CONDUIT ARRANGEMENT

20200282129 ยท 2020-09-10

Assignee

Inventors

Cpc classification

International classification

Abstract

A conduit arrangement (1) comprises distal and proximal ends (2,3) and two tubular lumens (10,11). Each tubular lumen (10,11) comprises a longitudinal axis extending between the distal and proximal ends (2,3) and independently permits fluid communication between the distal and proximal ends (2,3). The interior of each of the two tubular lumens is made from a biocompatible material. At least a portion of at least one tubular lumen (10, 11) is capable of imparting helical flow on fluid passing through said portion of the tubular lumen (10,11). The helical flow is spiral laminar flow.

Claims

1. A conduit arrangement comprising distal and proximal ends and two tubular lumens, wherein each tubular lumen comprises a longitudinal axis extending between the distal and proximal ends and independently permits fluid communication between the distal and proximal ends and wherein the interior of each of the two tubular lumens is made from a biocompatible material, wherein at least a portion of at least one tubular lumen is capable of imparting helical flow on fluid passing through said portion of the tubular lumen and wherein said helical flow is spiral laminar flow.

2. The conduit arrangement according to claim 1, wherein the conduit arrangement comprises a tubular conduit and a septum which divides the tubular conduit parallel to its longitudinal axis so as to define the two tubular lumens.

3. The conduit arrangement according to claim 2, wherein the septum extends substantially across a diameter of the tubular conduit.

4. The conduit arrangement according to claim 1, wherein the conduit arrangement comprises a tubular conduit and wherein the two tubular lumens are located side-by-side in said tubular conduit.

5. The conduit arrangement according to claim 1, wherein the conduit arrangement comprises a tubular conduit comprising an outer wall, which defines an outer tubular lumen, and an inner wall, which defines an inner tubular lumen, and wherein the outer tubular lumen and the inner tubular lumen extend coaxially between the distal and proximal ends of the conduit arrangement.

6. The conduit arrangement according to claim 5, wherein the inner tubular lumen further comprises a subconduit which passes through the outer wall of the tubular conduit.

7. The conduit arrangement according to claim 1, wherein the pathway of each of the two tubular lumens is straight with respect to the longitudinal axis of each tubular lumen.

8. The conduit arrangement according to claim 1, wherein said portion of the tubular lumen comprises an axially extending internal helical protrusion located around the inside of the tubular lumen for imparting helical flow on fluid passing through said portion of the tubular lumen.

9. The conduit arrangement according to claim 1, wherein said portion of the tubular lumen follows a helical pathway.

10. The conduit arrangement according to claim 1, wherein sequential noncircular cross-sections of said portion of the tubular lumen transition rotationally along the longitudinal axis of the tubular lumen.

11. The conduit arrangement according to claim 1, wherein the conduit arrangement comprises first and second tubular conduits fused together, one of the tubular lumens being located in the first tubular conduit and the other of the tubular lumens being located in the second tubular conduit.

12. The conduit arrangement according to claim 11, wherein each of the two tubular lumens independently follows a helical pathway.

13. The conduit arrangement according to claim 11, wherein at least one of the tubular lumens comprises an axially extending internal helical protrusion located around the inside of the tubular lumen for imparting helical flow on fluid passing through the tubular lumen.

14. A catheter comprising the conduit arrangement according to claim 1.

15. A method of transferring fluid comprising the use of a conduit arrangement comprising distal and proximal ends and two tubular lumens, wherein each tubular lumen comprises a longitudinal axis extending between the distal and proximal ends and independently permits fluid communication between the distal and proximal ends and wherein the interior of each of the two tubular lumens is made from a biocompatible material, wherein at least a portion of at least one tubular lumen is capable of imparting helical flow on fluid passing through said portion of the tubular lumen and wherein said helical flow is spiral laminar flow.

16. The method according to claim 15, wherein the fluid is transferred to and/or from an individual.

17. The method according to claim 16, wherein the method comprises the use of a catheter comprising the conduit arrangement.

18. The method according to claim 15, wherein the fluid is blood.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0042] FIG. 1 is a perspective view of a tubular conduit, in accordance with a first embodiment of the present invention, showing views along each of the lines A-A, B-B and C-C.

[0043] FIG. 2 is a perspective view of a tubular conduit, in accordance with a second embodiment of the present invention, showing views along each of the lines A-A, B-B and C-C.

[0044] FIG. 3 is a perspective view of a portion of a tubular conduit, in accordance with a third embodiment of the present invention, with some hidden detail shown in dashed lines.

[0045] FIG. 4 is a perspective view of a portion of a conduit arrangement, in accordance with a fourth embodiment of the present invention.

[0046] FIG. 5 is a perspective view of a portion of a conduit arrangement, in accordance with a variant of the fourth embodiment of the present invention.

[0047] FIG. 6 is a perspective view of a portion of a conduit arrangement, in accordance with a further variant of the fourth embodiment of the present invention.

[0048] FIG. 7 is a perspective view of a conduit arrangement, in accordance with a further variant of the fourth embodiment of the present invention.

[0049] FIG. 8 is a perspective view of a conduit arrangement, in accordance with a further variant of the fourth embodiment of the present invention.

[0050] FIG. 9 is a perspective view of a portion of a tubular conduit, in accordance with a fifth embodiment of the present invention, with some hidden detail shown in dashed lines.

[0051] FIG. 10A is a cross-sectional view of an outflow lumen of a tubular conduit through a plane perpendicular to the longitudinal axis of the tubular conduit.

[0052] FIG. 10B is an enlarged section showing detail of the base of an axially extending internal helical protrusion as circled in FIG. 10A.

DETAILED DESCRIPTION OF THE INVENTION

[0053] Referring to FIG. 1, a tubular conduit 1 in accordance with a first embodiment of the present invention is shown. The tubular conduit 1 comprises proximal and distal ends 2, 3 and a longitudinal axis 4 therebetween. As can be seen from the views along each of the lines A-A, B-B and C-C, the tubular conduit 1 is defined by an axially extending, elliptical perimeter wall 5 which defines the exterior of the tubular conduit 1. Thus, the tubular conduit 1 has an elliptical cross-section. The tubular conduit further comprises an axially extending septum 6, which extends substantially across a diameter of the tubular conduit 1. The inner surface 7 of the perimeter wall 5 of the tubular conduit 1 and each side 8, 9 of the septum 6 define two axially extending tubular lumens: an inflow lumen 10 and an outflow lumen 11. Each of the inflow lumen 10 and the outflow lumen 11 are D-shaped in cross-section and each independently permits fluid communication between the proximal and distal ends 2, 3 of the tubular conduit 1.

[0054] In this embodiment, each of the inflow and outflow lumens 10, 11 follows a helical pathway, with a helix angle of 20, between the proximal and distal ends 2, 3 of the tubular conduit 1 such that sequential non-circular cross-sections of the tubular conduit 1 transition rotationally along the length of the tubular conduit 1. The helical pathway of each of the inflow and outflow lumens 10, 11 between the proximal and distal ends 2, 3 of the tubular conduit 1 consists of one single revolution. That is to say, the pathway of each of the inflow and outflow lumens 10, 11 between the proximal and distal ends 2, 3 of the tubular conduit 1 makes one complete turn of 360.

[0055] In use, the tubular conduit 1 is comprised within a dialysis catheter (not shown) and the distal end 3 of the tubular conduit 1 is connected so as to be in fluid communication with a dialysis machine (not shown) and the proximal end 2 of the tubular conduit 1 is inserted into the vein of an individual who is suffering from kidney failure (not shown). At the distal end 3 of the tubular conduit 1, the inflow and outflow lumens 10, 11 separate into two independent conduits (not shown) so as to permit independently fluid communication with a dialysis machine (not shown). At the proximal end 2 of the tubular conduit 1, the inflow and outflow lumens 10, 11 also separate into two independent conduits so as to prevent mixing of the blood in the vein of the individual (not shown). In alternative embodiments, the proximal end 2 of each of the inflow and outflow lumens 10, 11 is staggered with respect to the other so as to prevent mixing of the blood in the vein of the individual (not shown).

[0056] Once the distal end 3 of the tubular conduit 1 is connected so as to be in fluid communication with the dialysis machine and the proximal end 2 is inserted into the vein of the individual, blood flows independently from the individual to the dialysis machine through the inflow lumen 10 of the tubular conduit 1 and from the dialysis machine to the individual through the outflow lumen 11 of the tubular conduit 1. As the blood passes through each of the inflow and outflow lumens 10, 11, the helical pathway of said lumens imparts helical flow on the blood, which reduces turbulence in the blood. The helical blood flow continues after the blood exits the outflow lumen 11 and enters the blood vessel of the individual. Thus turbulent blood flow is reduced, or even eliminated, in the blood vessel downstream of the outflow lumen 11.

[0057] In a variant of the first embodiment, the inflow and outflow lumens 10, 11 each follow a helical pathway along only a portion of the length of the tubular conduit 1. In this variant of the first embodiment, the inflow and outflow lumens 10, 11 each follow a helical pathway, with a helix angle of 20, between the proximal end 2 of the tubular conduit 1 and a termination point, which is short of the distal end 3 of the tubular conduit 1. In a further variant of the first embodiment, the inflow and outflow lumens 10, 11 each follow a helical pathway, with a helix angle of 20, between the distal end 3 of the tubular conduit 1 and a termination point, which is short of the proximal end 2 of the tubular conduit 1. The helical pathway of each of the inflow and outflow lumens 10, 11 between the proximal end 2 of the tubular conduit 1 and the termination point or, alternatively, between the distal end 3 of the tubular conduit 1 and the termination point consists of one single revolution. That is to say, the pathway of each of the inflow and outflow lumens 10, 11 between the proximal end 2 of the tubular conduit 1 and the termination point or, alternatively, between the distal end 3 of the tubular conduit 1 and the termination point makes one complete turn of 360. From the termination point to the distal end 3 of the tubular conduit or, alternatively, from the termination point to the proximal end 2 of the tubular conduit, the pathway of each of the inflow and outflow lumens 10, 11 is substantially straight with respect to the longitudinal axis 4 of the tubular conduit, subject to any overall curvature of the tubular conduit 1. It is to be appreciated that the total length of the tubular conduit 1 varies depending on its specific use. However, a dialysis catheter typically comprises a tubular conduit 1 that is between approximately 5 and 55 cm in length. In this variant, the proportion of the length of the tubular conduit 1 in which the inflow and outflow lumens 10, 11 follow a helical pathway varies but it is generally less than 50% of the total length of the tubular conduit 1. In preferred embodiments, the proportion of the length of the tubular conduit 1 in which the inflow and outflow lumens 10, 11 follow a helical pathway is less than 25% or less than 15% of the total length of the tubular conduit 1

[0058] In a further variant of the first embodiment, the length of the tubular conduit 1 in which the inflow and outflow lumens 10, 11 follow a helical pathway is selected with reference to the diameter of the lumen of the tubular conduit 1. This relationship is explained in Table 1 below. For example, for a tubular conduit with a lumen diameter of 2 mm, the minimum length of the tubular conduit in which the inflow and outflow lumens 10, 11 follow a helical pathway would be 17.26 mm. In embodiments such as the first embodiment, where each lumen 10, 11 of the tubular conduit is D-shaped, the diameter of the lumen is taken as an approximation or average of the diameter of the D-shaped lumen.

TABLE-US-00001 TABLE 1 Relationship between lumen diameter and minimum length of helical flow inducing means Minimum length of helical flow Lumen Diameter (mm) inducing means (mm) 1 8.63 2 17.26 3 25.89 4 34.53 5 43.16 6 51.79 7 60.42 8 69.05 9 77.68 10 86.31 11 94.95 12 103.58 13 112.21 14 120.84 15 129.47 16 138.10 17 146.73 18 155.37 19 164.00 20 172.63

[0059] In the first embodiment and the variants of the first embodiment described above, the helical pathway of each of the inflow and outflow lumens 10, 11 consists of one single revolution. However, in alternative embodiments, the helical pathway of each of the inflow and outflow lumens 10, 11 is either shorter or longer than one single revolution and is, for example, between 50% and 150% of a single revolution.

[0060] In use, the variants of the first embodiment operate in substantially the same way as the first embodiment. As blood passes through each of the inflow and outflow lumens 10, 11 in the portion of the length of the tubular conduit 1 that follows a helical pathway, helical flow is imparted on the blood which reduces turbulence in the blood. Furthermore, the helical flow of the blood in the inflow or outflow lumens 10, 11 continues after the blood passes the termination point of the helical pathway. Therefore, turbulent blood flow is likewise reduced, or even eliminated, along the length of the inflow or outflow lumen 10, 11. Similarly, the helical blood flow continues after the blood exits the outflow lumen 11 at the proximal end 2 of the tubular conduit 1 and enters the blood vessel of the individual. Thus turbulent blood flow is reduced, or even eliminated, in the blood vessel downstream of the outflow lumen 11.

[0061] Referring to FIG. 2, a tubular conduit 1 in accordance with a second embodiment of the present invention is shown. The tubular conduit 1 comprises proximal and distal ends 2, 3 and a longitudinal axis 4 therebetween. As can be seen from the views along each of the lines A-A, B-B and C-C, the tubular conduit 1 is defined by an axially extending, elliptical perimeter wall 5 which defines the exterior of the tubular conduit 1. Thus, the tubular conduit 1 has an elliptical cross-section. The tubular conduit 1 further comprises an axially extending septum 6, which extends substantially across a diameter of the tubular conduit. The inner surface 7 of the perimeter wall 5 of the tubular conduit 1 and each side 8, 9 of the septum 6 define two axially extending tubular lumens 10, 11: an inflow lumen 10 and an outflow lumen 11. Each of the inflow lumen 10 and the outflow lumen 11 is D-shaped in cross-section and each independently permits fluid communication between the proximal and distal ends 2, 3 of the tubular conduit 1. Located around the inner surface 7 of the perimeter wall 5 and the side 9 of the septum 6 is an axially extending internal helical protrusion 12 which projects radially inwardly into the outflow lumen 11. The helix angle of the axially extending internal helical protrusion 12 is 20. In this embodiment, the cross-section of the axially extending internal helical protrusion 12 perpendicular to the longitudinal axis 4 of the tubular conduit 1 is of a bell shape. Sequential views along each of the lines A-A, B-B and C-C demonstrate the location of the axially extending internal helical protrusion 12 along the length of the tubular conduit 1. In this embodiment, the axially extending internal helical protrusion 12 consists of one single revolution. That is to say, the axially extending internal helical protrusion makes one complete turn of 360 between the proximal and distal ends 2, 3 of the tubular conduit 1.

[0062] In use, the tubular conduit 1 is comprised within a dialysis catheter (not shown) and the distal end 3 of the tubular conduit 1 of the second embodiment is connected so as to be in fluid communication with a dialysis machine (not shown) and the proximal end 2 of the tubular conduit 1 is inserted into the vein of an individual who is suffering from kidney failure (not shown). The structure of the proximal and distal ends 2, 3 of the tubular conduit 1 can be the same as that described above in relation to the first embodiment.

[0063] Once the distal end 3 of the tubular conduit 1 is connected so as to be in fluid communication with the dialysis machine and the proximal end 2 is inserted into the vein of the individual, blood flows independently from the individual to the dialysis machine through the inflow lumen 10 of the tubular conduit 1 and from the dialysis machine to the individual through the outflow lumen 11 of the tubular conduit 1. As the blood passes the axially extending internal helical protrusion 12 of the outflow lumen 11, helical flow is imparted on the blood, which reduces turbulence in the blood. Furthermore, the helical blood flow continues after the blood exits the outflow lumen 11 and enters the blood vessel of the individual. Thus turbulent blood flow is reduced, or even eliminated, in the blood vessel downstream of the outflow lumen 11.

[0064] In a variant of the second embodiment, the axially extending internal helical protrusion 12 extends for only a portion of the length of the tubular conduit 1. In this variant of the second embodiment, the axially extending internal helical protrusion 12 extends around the inner surface 7 of the wall 5 and the side 9 of the septum 6 from the proximal end 2 of the tubular conduit 1 to a termination point, which is short of the distal end 3 of the tubular conduit 1. In a further variant of the first embodiment, the axially extending internal helical protrusion 12 extends around the inner surface 7 of the wall 5 and the side 9 of the septum 6 from the distal end 3 of the tubular conduit 1 to a termination point, which is short of the proximal end 2 of the tubular conduit 1. The helix angle of the axially extending internal helical protrusion 12 is 20. The axially extending internal helical protrusion 12 consists of one single revolution. That is to say, the axially extending internal helical protrusion 12 makes one complete turn of 360 between the proximal and distal ends 2, 3 of the tubular conduit 1. It is to be appreciated that the total length of the tubular conduit 1 varies depending on its specific use. However, a dialysis catheter typically comprises a tubular conduit 1 that is between approximately and 55 cm in length The proportion of the length of the tubular conduit 1 which comprises an axially extending internal helical protrusion 12 varies but it is generally less than 50% of the total length of the tubular conduit 1. In preferred embodiments, the proportion of the length of the tubular conduit 1 which comprises the axially extending internal helical protrusion 12 is less than 25% or less than 15% of the total length of the tubular conduit 1.

[0065] In a further variant of the second embodiment, the length of the axially extending internal helical protrusion 12 is selected with reference to the diameter of the lumen of the tubular conduit 1, as discussed above with reference to the first embodiment and Table 1.

[0066] In the variants of the second embodiment described above, the axially extending internal helical protrusion 12 consists of one single revolution. However, in alternative variants, the axially extending internal helical protrusion is either shorter or longer than one single revolution and may, for example, be between 50% and 150% of a single revolution.

[0067] In use, the variants of the second embodiment operate in substantially the same manner as is described for the second embodiment. As the blood passes through the outflow lumen 11 in the portion of the tubular conduit 1 that comprises the axially extending internal helical protrusion 12, helical flow is imparted on the blood which reduces turbulence in the blood. Furthermore, the helical blood flow continues after the blood passes the termination point of the axially extending internal helical protrusion 12. Therefore, turbulent flow is reduced, or even eliminated, along the length of the outflow lumen 11 that downstream of the termination point. Similarly, the helical blood flow continues after the blood exits the outflow lumen 11 at the proximal end of the tubular conduit 1 and enters the blood vessel of the individual. Thus turbulent blood flow is reduced, or even eliminated, in the blood vessel downstream of the outflow lumen 11.

[0068] In the first and second embodiments, the tubular conduit 1, 1 has an elliptical cross-section. However, in alternative embodiments, the tubular conduit 1, 1 has a circular cross-section or a substantially circular cross section.

[0069] In the first and second embodiments, the septum 6, 6 extends substantially across a diameter of the tubular conduit 1, 1. However, in alternative embodiments, the septum 6, 6 follows a curved or an S-shaped path perpendicular to the longitudinal axis 4, 4 of the tubular conduit 1, 1.

[0070] Referring to FIG. 3, a portion of a tubular conduit 13 in accordance with a third embodiment of the present invention is shown. The tubular conduit 13 comprises proximal and distal ends 14, 15 and a longitudinal axis 16 therebetween. An axially extending, tubular inner wall 17 defines an inflow lumen 18 of relatively small diameter and an axially extending, tubular outer wall 19 defines an outflow lumen 20 of relatively large diameter. In addition, the axially extending, tubular outer wall 19 defines the exterior of the tubular conduit 13. The inner wall 17 shares the longitudinal axis 16 of the tubular conduit 13 such that the inner wall 17 and the outer wall 19 extend coaxially between the proximal and distal ends 14, 15 of the tubular conduit 13. The inflow lumen 18 has a circular cross-section and the outflow lumen 20 has a ring-shaped cross-section and each of the inflow and outflow lumens 18, 20 independently permits fluid communication between the proximal and distal ends 14, 15 of the tubular conduit 13. The tubular conduit 13 has a circular cross-section. Located around the inner surface 22 of the outer wall 19 is an axially extending, internal helical protrusion 21, which projects radially inwardly into the outflow lumen 20. The helix angle of the axially extending internal helical protrusion 21 is 20. In this embodiment, the cross-section of the axially extending internal helical protrusion 21 perpendicular to the longitudinal axis 16 of the tubular conduit 13 is of a bell shape. The axially extending internal helical protrusion 21 extends between the proximal and distal ends 14, 15 of the tubular conduit 13 and consists of one single revolution. That is to say, the axially extending internal helical protrusion 21 makes one complete turn of 360 between the proximal and distal ends 14, 15 of the tubular conduit 13. In alternative embodiments, the axially extending internal helical protrusion 21 is either shorter or longer than one single revolution and may, for example, be between 50% and 150% of a single revolution.

[0071] In some embodiments, the axially extending internal helical protrusion 21 projects radially inwardly into the outflow lumen 20 to the extent that it contacts the axially extending, tubular inner wall 17. Thus, the axially extending, tubular inner wall 17 is supported in the centre of the outflow lumen 20 by the axially extending internal helical protrusion 21 (not shown).

[0072] In some embodiments, at each of the proximal and distal ends 14, 15 of the tubular conduit 13, the inner wall 17 penetrates and passes through the outer wall 19 of the tubular conduit 13 via a subconduit (not shown). At these points, the path of the inflow lumen 18 therefore passes across the path of the outflow lumen 20, to the exterior of the tubular conduit 13. In an alternative embodiment, at the proximal end 14 of the tubular conduit 13, the proximal ends of each of the inner wall 17 and the outer wall 19 are staggered (not shown). Specifically, the proximal end of the inner wall 17 extends beyond the proximal end of the outer wall 19. Thus the inflow lumen 18 extends beyond the outflow lumen 20 at the proximal end 14 of the tubular conduit.

[0073] In a variant of the third embodiment, the axially extending internal helical protrusion 21 extends for only a portion of the length of the tubular conduit 13. The description of the variants of the first and second embodiments are also relevant to this variant of the third embodiment.

[0074] In use, the tubular conduit 13 is comprised within a dialysis catheter (not shown) and the distal end 15 of the tubular conduit 13 is connected so as to be in fluid communication with a dialysis machine (not shown) and the proximal end 14 of the tubular conduit 13 is inserted into the vein of an individual who is suffering from kidney failure (not shown). The structure of the proximal and distal ends 14, 15 of the tubular conduit 13 can be analogous to that described above in relation to the first embodiment.

[0075] Once the distal end 15 of the tubular conduit 13 is connected so as to be in fluid communication with the dialysis machine and the proximal end 14 is inserted into the vein of the individual, blood flows independently from the individual to the dialysis machine through the inflow lumen 18 of the tubular conduit 13 and from the dialysis machine to the individual through the outflow lumen 20 of the tubular conduit 13. As the blood passes the axially extending internal helical protrusion 21 of the outflow lumen 20, helical flow is imparted on the blood, which reduces turbulence in the blood. Furthermore, the helical blood flow continues after the blood exits the outflow lumen 20 and enters the blood vessel of the individual. Thus turbulent blood flow is reduced, or even eliminated, in the blood vessel downstream of the outflow lumen 20.

[0076] Referring to FIG. 4, a portion of a conduit arrangement 23 in accordance with a fourth embodiment of the present invention is shown. The conduit arrangement 23 comprises first and second tubular conduits 24, 25, which each comprise proximal 26, 27 and distal 28, 29 ends and a tubular perimeter wall 30, 31 that extends therebetween. The tubular perimeter wall 30, 31 defines the exterior of the first and second tubular conduits 24, 25. Thus, the first and second tubular conduits have circular cross-sections. The tubular perimeter wall 30, 31 of the first and second tubular conduits 24, further defines first and second tubular lumens 32, 33: an inflow lumen 32 and an outflow lumen 33. Each of the inflow and outflow lumens 32, 33 are circular in cross-section and each independently permits fluid communication between the proximal 26, 27 and distal 28, 29 ends of the tubular conduits 24, 25.

[0077] The first and second tubular conduits 24, 25 are intertwined such that each of the inflow and outflow lumens 32, 33 independently follows a helical pathway, having a helix angle of 20, between the proximal 26, 27 and distal 28, 29 ends of the tubular conduits 24, 25. In some embodiments, the outer surface 34, 35 of the tubular perimeter wall 30, 31 of the first and second tubular conduits 24, 25 is fused together along the length of the first and second tubular conduits 24, 25 for stabilising the conduit arrangement 23. In other embodiments, at least a portion of the outer surface 34, 35 of the tubular perimeter wall 30, 31 of the first and second tubular conduits 24, is fused together at intersection points (not shown) for stabilising the conduit arrangement 23.

[0078] In a variant of the fourth embodiment, the conduit arrangement 23 is stabilised by embedding the first and second tubular conduits 24, 25 within a single, relatively larger tubular structure, as shown in FIG. 5. Referring to FIG. 6, a further variant of the fourth embodiment is shown in which the proximal end 27 of the second tubular conduit extends beyond the proximal end 26 of the first tubular conduit 24. Thus the outflow lumen 33 extends beyond the inflow lumen 32 at the proximal end 26, 27 of the conduit arrangement 23.

[0079] In a further variant of the fourth embodiment, the inflow and outflow lumens 32, 33 independently follow a helical pathway along only a portion of the conduit arrangement 23. An example of such a variant is shown in FIG. 7. The description of the variants of the first and second embodiments are also relevant to this variant of the fourth embodiment.

[0080] Referring to FIG. 8, yet a further variant of the fourth embodiment is shown in which there is located around the inner surface 51 of the tubular perimeter wall 31 an axially extending, internal helical protrusion 50, which projects radially inwardly into the outflow lumen 33. The helix angle of the axially extending internal helical protrusion 50 is 20. In this embodiment, the cross-section of the axially extending internal helical protrusion 50 perpendicular to the longitudinal axis 52 of the tubular conduit 25 is of a bell shape. The axially extending internal helical protrusion 50 extends between the proximal and distal ends 27, 29 of the second tubular conduit 25 and consists of one single revolution. That is to say, the axially extending internal helical protrusion 50 makes one complete turn of 360 between the proximal and distal ends 27, 29 of the second tubular conduit 25. In alternative embodiments, the axially extending internal helical protrusion 50 is either shorter or longer than one single revolution and may, for example, be between 50% and 150% of a single revolution. In yet further variants of the fourth embodiment described above and as shown in FIGS. 4 to 7, the internal helical protrusion of the variant shown in FIG. 8 is provided in the outflow lumen 33 thereof.

[0081] In use of the fourth embodiment (depicted in FIGS. 4 to 8), the conduit arrangement 23 is comprised within a dialysis catheter (not shown) and the distal ends 28, 29 of the first and second tubular conduits 24, 25 are connected so as to be in fluid communication with a dialysis machine (not shown) and the proximal ends 26, 27 of the first and second tubular conduits 24, 25 are inserted into the vein of an individual who is suffering from kidney failure (not shown). The structure of the proximal and distal ends 26, 27 of the conduit arrangement 23 can be analogous to that described above in relation to the first embodiment.

[0082] Once the distal ends 28, 29 of the first and second tubular conduits 24, 25 are connected so as to be in fluid communication with the dialysis machine and the proximal ends 26, 27 are inserted into the vein of the individual, blood flows independently from the individual to the dialysis machine through the inflow lumen 32 of the first tubular conduit 24 and from the dialysis machine to the individual through the outflow lumen 33 of the second tubular conduit 25. As the blood passes through the two lumens 32, 33 the helical pathway of said lumens imparts helical flow on the blood, which reduces turbulence in the blood. The helical blood flow continues after the blood exits the outflow lumen 33 and enters the blood vessel of the individual. Thus turbulent blood flow is reduced, or even eliminated, in the blood vessel downstream of the outflow lumen 33.

[0083] Referring to FIG. 9, a portion of a tubular conduit 38 in accordance with a fifth embodiment of the present invention is shown. The tubular conduit 38 comprises proximal and distal ends 39, 40 and a longitudinal axis therebetween 41. The tubular conduit 38 is defined by an axially extending tubular wall 42. Thus, the tubular conduit 38 has a circular cross-section. The tubular conduit further comprises two axially extending tubular lumens 43, 44: an inflow lumen 43 and an outflow lumen 44. Each of the inflow and outflow lumens 43, 44 is defined by an inner surface 45, 46 of the axially extending tubular wall 42 and each of the inflow and outflow lumens 43, 44 is substantially circular in cross-section. The inflow and outflow lumens 43, 44 are located side-by-side within the tubular conduit 38 and each of said lumens follows a pathway which is substantially straight with respect to the longitudinal axis 41 of the tubular conduit 38, subject to any overall curvature of the tubular conduit 38. Each of the inflow and outflow lumens 43, 44 independently permits fluid communication between the proximal and distal ends 39, 40 of the tubular conduit 38. Located around the inner surface 46 of the axially extending tubular wall 42 which defines the outflow lumen 44 is an axially extending internal helical protrusion 47, which projects radially inwardly into the outflow lumen 44. The helix angle of the axially extending internal helical protrusion 47 is 20. In this embodiment, the cross-section of the axially extending internal helical protrusion 47 perpendicular to the longitudinal axis 41 of the tubular conduit 38 is of a bell shape. The axially extending internal helical protrusion 47 extends between the proximal and distal ends 39, 40 of the tubular conduit 38 and consists of one single revolution. That is to say, the axially extending internal helical protrusion 47 makes one complete turn of 360 between the proximal and distal ends 39, 40 of the tubular conduit 38. In alternative embodiments, the axially extending internal helical protrusion 47 is either shorter or longer than one single revolution and may, for example, be between 50% and 150% of a single revolution.

[0084] In a variant of the fifth embodiment, the axially extending internal helical protrusion 47 extends for only a portion of the length of the tubular conduit 38. The description of the variants of the first and second embodiments are also relevant to this variant of the fifth embodiment.

[0085] In use, the distal end 40 of the tubular conduit 38 is connected so as to be in fluid communication with a dialysis machine (not shown) and the proximal end 39 of the tubular conduit 38 is inserted into the vein of an individual who is suffering from kidney failure (not shown). The structure of the proximal and distal ends 39, 40 of the tubular conduit 38 can be analogous to that described above in relation to the first embodiment.

[0086] Once the distal end 40 of the tubular conduit 38 is connected so as to be in fluid communication with the dialysis machine and the proximal end 39 is inserted into the vein of the individual, blood flows independently from the individual to the dialysis machine through the inflow lumen 43 of the tubular conduit 38 and from the dialysis machine to the individual through the outflow lumen 44 of the tubular conduit 38. As the blood passes the axially extending internal helical protrusion 47 of the outflow lumen 44, helical flow is imparted on the blood, which reduces turbulence in the blood. Furthermore, the helical blood flow continues after the blood exits the outflow lumen 44 and enters the blood vessel of the individual. Thus turbulent blood flow is reduced, or even eliminated, in the blood vessel downstream of the outflow lumen 44.

[0087] In one embodiment, the tubular conduit 1, 1, 13, 24, 25, 38 is made from polyurethane. However, in alternative embodiments, the tubular conduit 1, 1, 13, 24, 25, 38 is made from PVC, PTFE, latex, silicone or carbothane. The interior of each of the inflow and outflow lumens 10, 11, 10, 11, 18, 20, 32, 33, 43, 44 is made from a biocompatible material. In the embodiments described above, the tubular conduit 1, 1, 13, 24, 25, 38 is flexible. The conduit arrangement 23 of the fourth embodiment is also flexible.

[0088] In the embodiments described above, the helical flow imparted on the blood in the tubular lumen is spiral laminar flow such that natural blood flow patterns are replicated. Spiral laminar flow has been observed in vivo in both animals and humans and may be a constant (veins primarily) or pulsatile (arteries) flow waveform. In the tubular lumen of the embodiments of the present invention, spiral laminar flow means that in addition to the laminar flow in the direction of the tubular conduit, there is a rotation in the plane of the cross-section of the tubular conduit, produced by the portion of the tubular lumen that is capable of imparting helical flow.

[0089] If the tubular conduit of any of the embodiments described above were to comprise a narrowed section or a bifurcation or branch, spiral laminar flow would be maintained through the narrowing of a tubular conduit and beyond the braches or bifurcations of the tubular conduit.

[0090] In the embodiments described above, the cross-section of the axially extending internal helical protrusion 12, 21, 47, 50 perpendicular to the longitudinal axis 4, 16, 41, 52 of the tubular conduit 1, 13, 38, 25 is of a symmetric bell shape. However, in variants of these embodiments, the axially extending internal helical protrusion 12, 21, 47, 50 instead has an asymmetrical cross-section.

[0091] Referring to FIG. 10, a cross-section of an axially extending internal helical protrusion 60 with an asymmetric profile is shown. As shown in FIG. 10, the axially extending internal helical protrusion has a first face 61 and a second face 62 coupled together by a curved surface 63. The main central section of the first face 61 is at an angle of approximately 10 to a diameter 64 of the tubular conduit 65 that intersects the curved surface 63. The main central section of the second face 62 is at an angle of approximately 38 to a diameter 64 of the tubular conduit 65 that intersects the curved surface 63. The height 65 of the axially extending internal helical protrusion 60 is half the radius of the tubular conduit 65. In variants of the second, third, fourth and fifth embodiments of the present invention described above, an axially extending internal helical protrusion 60 having an asymmetric cross-section, as shown in FIG. 10, is provided.

[0092] In use, the tubular conduit 65 comprising the axially extending internal helical protrusion 60 with the asymmetric profile is orientated so that the blood flow is against the first face 61.

[0093] In alternative embodiments, the axially extending internal helical protrusion 12, 21, 47, 50 has a different cross-section perpendicular to the longitudinal axis 4, 16, 41, 52 of the tubular conduit 1, 13, 38, 25, instead of a bell shape, such as having a U-shaped cross-section as is described in WO03/045279 or a triangular cross-section such as described in WO2005/004751, each of which are incorporated herein by reference.

[0094] In the embodiments described above, the helix angle of the helical pathway or the axially extending internal helical protrusion 12, 21, 47, 50 is 20. However, in other embodiments the helical pathway or the axially extending internal helical protrusion 12, 21, 47, 50 has a helix angle of between 5 and 50, 5 and 40, 5 and 30, 5 and 25 and preferably between 5 and 20, more preferably between 8 and 20.

[0095] In the embodiments described above, the axially extended internal helical protrusion 12, 21, 47 of the second, third or fifth embodiments; the portion of the tubular conduit 1 that follows a helical pathway in the first embodiment; or the portion of the conduit arrangement 23 in which the inflow and outflow lumens 32, 33 independently following a helical pathway in the fourth embodiment is comprised within a portion of the dialysis catheter that is not implanted into the body of an individual. However, in alternative embodiments, the feature is comprised within a portion of the dialysis catheter that is implanted into the body of an individual.

[0096] The first embodiment described above is manufactured using the following method. The tubular conduit 1 is extruded using standard techniques known in the art. The portion of the tubular conduit 1 is which the inflow and outflow lumens 10, 11 follow a helical pathway is manufactured through use of a rotating extrusion die during the extrusion process. In an alternative method of manufacture, the tubular conduit 1 is extruded such that the inflow and outflow lumens 10, 11 follow a substantially straight pathway. The helical pathway of the inflow and outflow lumens 10, 11 is then introduced post-extrusion using appropriate tools and temperature.

[0097] The fourth embodiment described above is manufactured using a similar method as for the first embodiment. The first and second tubular conduits 24, 25 are extruded using standard techniques known in the art. The first and second tubular conduits 24, 25 are intertwined such that the inflow and outflow lumens 32, 33 independently follow a helical pathway through use of a rotating extrusion die during the extrusion process. In an alternative method of manufacture, the first and second tubular conduits 24, 25 extruded such that the inflow and outflow lumens 32, 33 follow a substantially straight pathway. The first and second tubular conduits 24, 25 are then intertwined post-extrusion using appropriate tools and temperature.

[0098] The second, third and fifth embodiments described above are manufactured using the following method. The axially extending internal helical protrusion 12, 21, 47 is produced by injection moulding and is then connected to rest of the tubular conduit 1, 13, 38 by using thermal or radio frequency (RF) fusion or by using solvent bonding or gluing. The tubular conduit 1, 13, 38 minus the axially extending internal helical protrusion is made using standard techniques in the field. The axially extending internal helical protrusion 12, 21, 47 is made from the same material as the rest of the tubular conduit 1, 13, 38.

[0099] Dual or multi-lumen catheters are used for various medical applications, aside from dialysis catheters, and may transfer fluids other than blood independently to and from an individual. Therefore, although the above described embodiments relate to dialysis catheters, it is to be understood that the present invention is not limited to dialysis catheters. The present invention may be embodied in other types of dual or multi-lumen catheters where it would be desirable to induce helical flow during the transfer of fluids independently to and from an individual, such as in urinary catheters, tracheotomy catheters, angioplasty catheters and central venous catheters.