Catheter with tapered self-introducing low-recirculation distal tip

Abstract

Disclosed is a multi-lumen catheter having a distal end catheter tip configured to improve fluid flow into and out from the catheter tip while reducing undesired recirculation during hemodialysis treatment of a patient. A first lumen and a second lumen each extends from the catheter proximal end to the catheter distal end, the first lumen and the second lumen being parallel to each other. A septum having a first side and a second side separates the first lumen from the second lumen. Some embodiments of the catheter tip include a beveled shape region, having a first lumen orifice, a second lumen orifice, and a septum top surface. Within the beveled shape region, at least a portion of the septum first side and at least a portion of the septum top surface form a first eave over the first lumen and at least a portion of the septum second side and at least a portion of the septum top surface form a second eave over the second lumen.

Claims

1. A low recirculation multi-lumen catheter, comprising: an elongated catheter body comprising a catheter top, a catheter bottom, a catheter first side, and a catheter second side; a proximal end; a distal end having a catheter tip; a first lumen extending from the catheter proximal end to the catheter distal end and a second lumen extending from the catheter proximal end to the catheter distal end, wherein the first lumen is substantially parallel to the second lumen; a septum comprising a septum first side adjacent the first lumen and a septum second side adjacent the second lumen, wherein the septum separates the first lumen from the second lumen; a central longitudinal axis extending from the catheter proximal end to the catheter distal end; a central longitudinal plane comprising the central longitudinal axis and extending from the catheter top to the catheter bottom; and a beveled shape region, having bilateral symmetry along the central longitudinal plane, comprising a first lumen orifice, a second lumen orifice, at least a portion of the septum first side, at least a portion of the septum second side, and a septum top surface; wherein the first lumen orifices and second lumen orifices locate entirely within the beveled shape region, the first lumen orifices and second lumen orifices having generally ovate shape; at least a portion of the septum first side and at least a portion of the septum top surface form a first eave over the first lumen; and at least a portion of the septum second side and at least a portion of the septum top surface form a second eave over the second lumen; the first eave and the second eave extends to at least half of the septum top surface; the first eave is configured to act as a baffle, when the first lumen is used to introduce fluid, to direct fluid flow out from the first lumen via the first lumen orifice, while restricting cross-over fluid flow to the second lumen; the second eave is configured to act as a baffle, when the second lumen is used to introduce fluid, to direct fluid flow out from the second lumen via the second lumen orifice, while restricting cross-over fluid flow to the first lumen; and the first eave comprises a region of the septum first side leading up into the septum top surface and a half of the septum top surface spanning from the central longitudinal plane to the first lumen orifice, the first eave have an arched shape that forms at least a portion of the first lumen orifice; and the second eave comprises a region of the septum second side leading up into the septum top surface and a half of the septum top surface spanning from the central longitudinal plane to the second lumen orifice, the second eave have an arched shape that forms at least a portion of the second lumen orifice.

2. The multi-lumen catheter of claim 1, comprising: a central latitudinal plane comprising the central longitudinal axis and extending from the catheter first side to the catheter second side; an upper latitudinal plane parallel to the central latitudinal plane and bisecting the septum top surface at the top of the first lumen orifice and at the top of the second lumen orifice; a central latitudinal axis extending along the central latitudinal plane and bisecting the septum top surface; and an upper latitudinal axis extending along the upper latitudinal plane and bisecting the septum top surface.

3. The multi-lumen catheter of claim 1, wherein the first lumen can be a dedicated suction line or a dedicated return line; and the second lumen can be a dedicated suction line or a dedicated return line.

4. The multi-lumen catheter of claim 2, wherein the catheter body comprises a generally oval or stadium shaped cross-section; a height, H.sub.1, measured along the central longitudinal axis and extending from the catheter bottom to the catheter top; and a width, W.sub.3, measured along the central latitudinal axis and extending from the catheter first side to the catheter second side; wherein H.sub.1 is less than W.sub.3.

5. The multi-lumen catheter of claim 2, wherein the septum comprises a width, W.sub.1, measured along the central latitudinal axis and extending from the septum first side to the septum second side; and a width, W.sub.2, measured along the upper latitudinal axis and extending from the septum first side to the septum second side, wherein W.sub.1 is less than W.sub.2.

6. The multi-lumen catheter of claim 2, wherein the beveled shape region comprises a chamfered edge at the distal end of the catheter, the chamfered edge having a thickness, Th.sub.1, measured along the central longitudinal plane.

7. The multi-lumen catheter of claim 1, wherein the beveled shape region comprises a bevel top edge at a proximal end of the beveled shape region and adjacent the catheter top, wherein the bevel top edge can be straight or curved.

8. The multi-lumen catheter of claim 2, wherein the septum comprises: a septum first segment extending along the septum top surface from the catheter distal end for a distance, D.sub.1, to the central latitudinal axis; and a septum second segment extending along the septum top surface from the central latitudinal axis for a distance, D.sub.2, to the upper latitudinal axis.

9. The multi-lumen catheter of claim 6, wherein the beveled shape region extends for a distance, D.sub.3, measured parallel to the central latitudinal plane, from the chamfered edge at the catheter distal end to a z-axis; wherein the z-axis is perpendicular to the central latitudinal plane, tangential to the bevel top edge, and extends from the catheter top to the catheter bottom.

10. The multi-lumen catheter of claim 2, wherein the catheter body has a thickness, Th.sub.2, and a thickness Th.sub.3, wherein Th.sub.2 is measured along the central longitudinal plane and extends from the catheter bottom to the central latitudinal plane; and Th.sub.3 is measured along the central longitudinal plane and extends from the catheter bottom to the upper latitudinal plane.

11. The multi-lumen catheter of claim 1, wherein the catheter body comprises at least one aperture extending through the catheter top and into at least one of the first lumen and the second lumen.

12. The multi-lumen catheter of claim 1, wherein the catheter body comprises at least one aperture extending through the catheter bottom and into at least one of the first lumen and the second lumen.

13. The multi-lumen catheter of claim 1, further comprising a third lumen adjacent the first lumen and adjacent the second lumen.

14. The multi-lumen catheter of claim 2, wherein the beveled shape region comprises a first sidewall forming an outer portion of the first lumen; and a second sidewall forming an outer portion of the second lumen; wherein a first lateral plane tangential to the first sidewall and normal to the central latitudinal plane is offset from the central longitudinal plane by an angle, A.sub.1; and a second lateral plane tangential to the second sidewall and normal to the central latitudinal plane is offset from the central longitudinal plane by an angle, A.sub.2.

15. The multi-lumen catheter of claim 1, wherein the beveled shape region comprises a first lumen orifice cross-section of the first lumen orifice, wherein the first lumen orifice cross-section can have a generally ovate shape, a generally oblong shape, or a generally tear-drop shape; and a second lumen orifice cross-section of the second lumen orifice, wherein the second lumen orifice cross-section can have a generally ovate shape, a generally oblong shape, or a generally tear-drop shape.

16. The multi-lumen catheter of claim 15, wherein the first lumen orifice cross-section has a generally ovate shape with a first major axis and a first minor axis and the second lumen orifice cross-section has a generally ovate shape with a second major axis and a second minor axis.

17. The multi-lumen catheter of claim 2, wherein the beveled shape region comprises at least one plane of symmetry, wherein the plane of symmetry is the central longitudinal plane.

18. The multi-lumen catheter of claim 1, wherein the catheter is configured to improve fluid flow into and out from the catheter tip and to reduce undesired recirculation during hemodialysis treatment of a patient.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The above and other objects, aspects, features, advantages and possible applications of the present innovation will be more apparent from the following more particular description thereof, presented in conjunction with the following drawings. Like reference numbers used in the drawings may identify like components.

(2) FIG. 1 shows an embodiment of the catheter in combination with a connector.

(3) FIG. 2A shows a top view of an embodiment of the catheter.

(4) FIG. 2B shows a bottom view of an embodiment of the catheter.

(5) FIG. 3 shows a side view of an embodiment of the catheter.

(6) FIG. 4 shows a partial bottom view of an embodiment of the catheter tip.

(7) FIG. 5 shows a partial top view of an embodiment of the catheter tip.

(8) FIG. 6A shows a partial side view of an embodiment of the catheter tip.

(9) FIG. 6B shows a partial side view of an embodiment of the catheter tip.

(10) FIG. 7 shows a front view of an embodiment of the catheter tip illustrating exemplary dimensions of aspects of the catheter tip.

(11) FIG. 8 shows a partial top view of an embodiment of the catheter tip illustrating exemplary dimensions of aspects of the catheter tip.

(12) FIG. 9 shows a partial top view of an embodiment of the catheter tip illustrating exemplary dimensions of aspects of the catheter tip.

(13) FIG. 10 shows an embodiment of the catheter in combination with a connector.

(14) FIG. 10A shows a cross-section of one embodiment of the catheter body.

(15) FIG. 11 shows an exemplary fluid flow that is characteristic of an embodiment of the catheter tip.

(16) FIG. 12A shows a partial perspective view of an embodiment of the catheter tip.

(17) FIG. 12B shows a partial top view of an embodiment of the catheter tip.

(18) FIG. 12C shows a partial side view of an embodiment of the catheter tip.

(19) FIG. 13A shows a partial perspective view of an embodiment of the catheter tip.

(20) FIG. 13B shows a partial perspective view of an embodiment of the catheter tip.

(21) FIG. 13C shows a front view of an embodiment of the catheter tip.

(22) FIG. 14 shows a cross-section of one embodiment of the catheter body.

DETAILED DESCRIPTION

(23) The following description is of exemplary embodiments that are presently contemplated for carrying out the present disclosure. This description is not to be taken in a limiting sense, but is made merely for the purpose of describing the general principles and features of the present disclosure. The scope of the present disclosure is not limited by this description.

(24) Referring to FIGS. 1-5, embodiments of the catheter 100 can include a catheter body 102 having a catheter proximal end 104 and a catheter distal end 106 with a central longitudinal axis 108 extending from the catheter proximal end 104 to the catheter distal end 106. The catheter body 102 can be a tubular member made from plastic, silicone, rubber, etc. The catheter body 102 can have a catheter top 112, a catheter bottom 114, a catheter first side 116, and a catheter second side 118. The catheter proximal end 104 can be configured to connect to a pump, reservoir, or other device for providing means to cause fluid to flow into and out from the catheter 100.

(25) The catheter distal end 106 can be formed into a catheter tip 120. The catheter tip 120 can be configured to be inserted into a portion of a patient's body. For example, the catheter tip 120 can be tapered so as to facilitate spearheading the insertion of the catheter 100 into a patient's body, which may include insertion into a vein of the patient.

(26) The catheter tip 120 can have at least one aperture 110 extending through the catheter top 112 or the catheter bottom 114. In at least one embodiment, the catheter 100 can have at least one aperture 110 formed in a portion thereof. For example, the catheter 100 can have an aperture 110 formed in the catheter top 112. The aperture 110 can extend into at least one of the first lumen 122a and the second lumen 122b. For instance, the catheter 100 can have a first aperture 110 formed in the catheter top 112 that extends into the first lumen 122a. The catheter 100 can have a second aperture 110 formed in the catheter top 112 that extends into the second lumen 122b. Some embodiments can include at least one aperture 110 formed in the catheter bottom 114. The aperture 110 formed in the catheter bottom 114 can extend into at least one of the first lumen 122a and the second lumen 122b. For instance, the catheter 100 can have a first aperture 110 formed in the catheter bottom 114 that extends into the first lumen 122a, a second aperture 110 formed into the catheter bottom 114 that extends into the first lumen 122a, a third aperture 110 formed in the catheter bottom 114 that extends into the second lumen 122b, and a fourth aperture 110 formed into the catheter bottom 114 that extends into the second lumen 122b.

(27) The apertures 110 can be used to prevent the catheter tip 120 from forming a vacuum when the distal end 106 the catheter 100 makes contact with a vein, which would limit movement and operability of the catheter 100. The apertures 110 relieve any suction that would be generated if the distal end 106 of the catheter 100 makes contact with a vein. However, the apertures 110 can also improve fluid flow. Placement, size, shape, and the number of apertures 110 can be set to meet specific design criteria. It has been found that use of only two apertures 110 in the catheter top 112, wherein a first aperture 110 is formed in the catheter top 112 so as to extend into the first lumen 122a and a second aperture 110 is formed into the catheter top 112 so that it extends into the second lumen 122b, provides the most beneficial effects to the fluid flow for the purposes of reducing undesired recirculation.

(28) The catheter body 102 can include at least one lumen 122 extending through at least a portion of the catheter body 102. The lumen 122 can be formed in the catheter body 102 so that it extends from the catheter proximal end 104 to the catheter distal end 106. In some embodiments, at least a portion of the lumen 122 can extend along the central longitudinal axis 108. For example, the catheter body 102 can have a first lumen 122a extending from the catheter proximal end 104 to the catheter distal end 106 and having a first lumen orifice 172a at the catheter distal end 106. The catheter body 102 can have a second lumen 122b extending from the catheter proximal end 104 to the catheter distal end 106 and having a second lumen orifice 172b at the catheter distal end 106. The first lumen 122a can be adjacent the second lumen 122b. In some embodiments, the first lumen 122a can be separated from the second lumen 122b by a septum 124. The septum 124 can be formed between the first lumen 122a and the second lumen 122b so as to extend along a central portion of the catheter body 102 from the catheter proximal end 104 to the catheter distal end 106.

(29) The catheter tip 120 can include a beveled shape region 130 at the distal end 106 of the catheter 100. The beveled shape region 130 can include a bevel top edge 164 at a proximal end of the beveled shape region and adjacent the catheter top 112. The bevel top edge can be straight or curved. The beveled shape region 130 can include a chamfered edge 136 at a distal end of the catheter tip 120. Within the beveled shape region 130, the septum 124 has a septum top surface 150. Within the beveled shape region 130, the first lumen 122a can have a first lumen orifice 172a having a first lumen orifice cross-section and the second lumen 122b can have a second lumen orifice 172b having a second lumen orifice cross-section.

(30) FIG. 6 illustrates side views of the catheter tip 120. The catheter tip 120 can include a beveled shape region 130 at the distal end 106 of the catheter 100. The beveled shape region 130 can include a chamfered edge 136 (FIG. 6A) having a thickness, Th.sub.1 (FIG. 6B). For example, Th.sub.1 can be within a range from 0.5 mm to 2.5 mm (e.g., 1.78 mm).

(31) A geometric plane along the central longitudinal axis 108 and extending from the catheter first side 116 to the catheter second side 118 defines a central latitudinal plane 128 (FIGS. 6A and 6B). A geometric plane parallel to the central latitudinal plane 128 and bisecting the septum top surface 150 at the top of the lumen orifice 172 defines an upper latitudinal plane 170 (FIGS. 6A and 6B). The septum top surface 150 can be bisected by the central latitudinal plane 128 at a central latitudinal axis 158 and the septum top surface 150 can be bisected by the upper latitudinal plane 170 at an upper latitudinal axis 156 (FIG. 6B). Within the beveled shape region 130, the septum 124 can have a septum first segment 160 (FIG. 6A) that extends along the septum top surface 150 from the catheter distal end 106 for a distance D.sub.1 to the central latitudinal axis 158 (FIG. 6B). The septum 124 can have a septum second segment 162 (FIG. 6A) that extends along the septum top surface 150 from the central latitudinal axis 158 for a distance D.sub.2 to the upper latitudinal axis 156 (FIG. 6B). For example, D.sub.1 can be within a range from 0.25 mm to 0.75 mm (e.g., 0.54 mm) and D.sub.2 can be within a range from 2.5 mm to 7.5 mm (e.g., 5.11 mm).

(32) A geometric axis perpendicular to the central latitudinal plane 128, extending from the catheter top 112 to the catheter bottom 114, and tangential to the bevel top edge 164 defines a z-axis 174 (FIG. 6B). The beveled shape region 130 can extend for a distance, D.sub.3, measured parallel to the central latitudinal plane 128, from the chamfered edge 136 at the catheter distal end 106 to the z-axis 174. For example, D.sub.3 can be within a range from 6.35 mm to 7.62 mm (i.e., 7.01 mm).

(33) The catheter body has a thickness, Th.sub.2, along the central longitudinal plane 126 and extending from the catheter bottom 114 to the central latitudinal plane 128 (FIG. 6B). The catheter body has a thickness, Th.sub.3, along the central longitudinal plane 126 and extending from the catheter bottom 114 to the upper latitudinal plane 170 (FIG. 6B). For example, Th.sub.2 can be within a range from 0.55 mm to 3.4 mm (e.g., 1.96 mm) and Th.sub.3 can be within a range from 1.0 mm to 8.7 mm (e.g., 3.48 mm).

(34) FIG. 7 is a front view of the beveled shape region 130 of the catheter tip 120. A geometric plane along the central longitudinal axis 108 and extending from the catheter first side 116 to the catheter second side 118 defines a central latitudinal plane 128. A geometric plane parallel to the central latitudinal plane 128 and bisecting the septum top surface 150 at the top of the first lumen 122a and the second lumen 122b defines an upper latitudinal plane 170. The septum top surface 150 can have a width, W.sub.1, where the septum top surface 150 is bisected by the central latitudinal plane 128. The septum top surface 150 can have a width, W.sub.2, where the septum top surface 150 is bisected by the upper latitudinal plane 170. W.sub.1 can be less than W.sub.2. For example, W.sub.1 can be within a range from 0.25 mm to 1.5 mm (e.g., 0.51 mm) and W.sub.2 can be within a range from 1.5 mm to 3.5 mm (e.g., 2.65 mm).

(35) The beveled shape region 130 can have a first sidewall 132 forming an outer portion of the first lumen 122a and a second sidewall 134 forming an outer portion of the second lumen 122b. For example, the first lumen 122a can be formed within the catheter body 102 and share a first sidewall 132 with that of the catheter first side 116. The second lumen 122b can be formed within the catheter body 102 and share a second sidewall 134 with that of the catheter second side 118.

(36) Septum 124 can have a septum first side 146 forming an inner portion of the first lumen 122a and a septum second side 148 forming an inner portion of the second lumen 122b. For example, the septum first side 146 can form at least part of the first lumen 122a and the septum second side 148 can form at least part of the second lumen 122b. For example, the first lumen 122a can extend along the catheter body 102 adjacent the catheter first side 116 so that the first sidewall 132 and the septum first side 146 form the first lumen 122a. The second lumen 122b can extend along the catheter body 102 adjacent the catheter second side 118 so that the second sidewall 134 and the septum second side 148 form the second lumen 122b.

(37) At least a portion of the septum first side 146 can have an arcuate shape. For example, the portion of the septum first side 146 leading up into the septum top surface 150 can be arched. At least a portion of the septum second side 148 can have an arcuate shape. For example, the portion of the septum second side 148 leading up into the septum top surface 150 can be arched.

(38) The septum top surface 150 can be bisected by central longitudinal plane 126. The half of the septum top surface 150 spanning from the central longitudinal plane 126 to the first lumen orifice 172a and the region of the septum first side 146 leading up into the septum top surface 150 can be referred to as the first eave 152. The half of the septum top surface 150 spanning from the central longitudinal plane 126 to the second lumen orifice 172b and the region of the septum second side 148 leading up into the septum top surface 150 can be referred to as the second eave 154. For example, the first eave 152 formed over the first lumen 122a includes a region of the septum first side 146 leading up into the septum top surface 150 and the half of the septum top surface 150 spanning from the central longitudinal plane 126 to the first lumen orifice 172a. The second eave 154 formed over the second lumen 122b includes a region of the septum second side 148 leading up into the septum top surface 150 and the half of the septum top surface 150 spanning from the central longitudinal plane 126 to the lumen second lumen orifice 172b. The first eave 152 can have a curved or arched shape that forms at least a portion of the first lumen orifice 172a and the second eave 154 can have a curved or arched shape that forms at least a portion of the second lumen orifice 172b. In some embodiments, the first eave 152 acts as a baffle to direct fluid flow out from the first lumen 122a via the first lumen orifice 172a, while restricting cross-over fluid flow to the second lumen orifice 172b, thereby reducing undesired recirculation. In some embodiments, the second eave 154 acts as a baffle to direct fluid flow out from the second lumen 122b via the second lumen orifice 172b, while restricting cross-over fluid flow to the first lumen orifice 172a, thereby reducing undesired recirculation.

(39) The beveled shape region 130 can have a chamfered edge 136 having a thickness, Th.sub.1. For example, Th.sub.1 can be within a range from 0.5 mm to 2.5 mm (e.g., 1.78 mm).

(40) In some embodiments, the catheter 100 can have a third lumen 122c having a third lumen orifice 172c at the catheter distal end 106. The third lumen 122c can extend along the catheter body 102, extending from the catheter proximal end 104 to the catheter distal end 106. The third lumen 122c can be positioned adjacent the first lumen 122a and adjacent the second lumen 122b. For example, the third lumen 122c can be positioned below the septum 124 and adjacent the catheter bottom 114. In some embodiments, the third lumen can have a generally circular shaped cross-section. In some embodiments, the third lumen 122c can be configured to facilitate insertion of a guidewire for easier manipulation of the catheter 100.

(41) FIG. 8 illustrates a top perspective view of the catheter tip 120. Within the beveled shape region 130, the catheter top 112 can lead into the septum top surface 150. For example, within the catheter body 102, the septum 124 can be a member extending from the catheter bottom 114 to the catheter top 112, but within the beveled shape region 130, the catheter top 112 gives way to (meaning to lead into and take the shape of) the septum top surface 150. The beveled shape region 130 can have a bevel top edge 164 at a proximal end of the beveled shape region and adjacent the catheter top 112. For example, the bevel top edge can be straight. In some embodiments, the bevel top edge can be curved.

(42) Within the beveled shape region 130, the first lumen 122a can have a first lumen orifice 172a having a first lumen orifice cross-section. The first lumen orifice cross-section can have a generally ovate shape, a generally oblong shape, or a generally tear-drop shape, etc. Within the beveled shape region 130, the second lumen 122b can have a second lumen orifice 172b having a second lumen orifice cross-section. The second lumen orifice cross-section can have a generally ovate shape, a generally oblong shape, or a generally tear-drop shape, etc. For example, the first lumen orifice cross-section can have a generally ovate shape with a first major axis 138 and a first minor axis 140. The second lumen orifice cross-section can have a generally ovate shape with a second major axis 142 and a second minor axis 144. In some embodiments, the length of the first major axis 138 equals the length of the second major axis 142 and the length of the first minor axis 140 equals the length of the second minor axis 144. For example, any one of the first major axis 138 and the second major axis 142 can be within a range from 5.0 mm to 10.0 mm (e.g., 7.06 mm) and any one of the first minor axis 140 and the second minor axis 144 can be within a range from 0.5 mm to 3.0 mm (e.g., 1.47 mm). A ratio of a first major axis 138 to a first minor axis 140 can be within a range from 3 to 5 (e.g., 4.8). A ratio of a second major axis 142 to a second minor axis 144 can be within a range from 3 to 5 (e.g., 4.8).

(43) In some embodiments, the first major axis 138 is not an axis of symmetry. In some embodiments, the second major axis 142 is not an axis of symmetry. In some embodiments, the first minor axis 140 is not an axis of symmetry. In some embodiments, the second minor axis 144 is not an axis of symmetry.

(44) FIG. 9 illustrates a top perspective view of the catheter tip 120. The beveled shape region 130 can have a first sidewall 132 forming an outer portion of the first lumen 122a and a second sidewall 134 forming an outer portion of the second lumen 122b. A first lateral plane 166 tangential to the first sidewall 132 and normal to the central latitudinal plane 128 can be offset from the central longitudinal plane 126 by an angle A.sub.1. A second lateral plane 168 tangential to the second sidewall 134 and normal to the central latitudinal plane 128 can be offset from the central longitudinal plane 126 by an angle A.sub.2. For example, Angle A.sub.1 can be within a range from 10 degrees to 30 degrees (e.g., 17.5 degrees) and Angle A.sub.2 can be within a range from 10 degrees to 30 degrees (e.g., 17.5 degrees). It is contemplated for the angle A.sub.1 to be equal to or essentially equal to the angle A.sub.2. In some embodiments, A.sub.1 does not equal A.sub.2.

(45) Referring to FIG. 10, in at least one embodiment, the catheter body 102 can be configured to have an oval or stadium shaped cross-section (FIG. 10A). For example, the catheter top 112 and the catheter bottom 114 can be of equal length, the catheter first side 116 and the catheter second side 118 can be of equal length, and the catheter top 112 and the catheter bottom 114 can each be longer than each of the catheter first side 116 and the catheter second side 118. The catheter body 102 where the catheter top 112 meets the catheter first side 116 can be smooth or arched, the catheter body 102 where the catheter top 112 meets the catheter second side 118 can be smooth or arched, the catheter body 102 where the catheter bottom 114 meets the catheter first side 116 can be smooth or arched, and the catheter body 102 where the catheter bottom 114 meets the catheter second side 118 can be smooth or arched.

(46) For example, cross-section “A-A” can be stadium shaped (FIG. 10A). For instance, the catheter body 102 can have a height, H.sub.1, defined along the central longitudinal plane 126 and extending from the catheter top 112 to the catheter bottom 114 that is within a range from 3.175 mm to 4.445 mm (e.g., 3.886 mm). The catheter body 102 can have a width, W.sub.3, defined along the central latitudinal plane 128 and extending from the catheter first side 116 to the catheter second side 118 that is within a range from 3.81 mm to 6.35 mm (e.g., 5.36 mm).

(47) Referring to FIG. 11, the shapes, dimensions, and ratios thereof disclosed herein are specifically designed to improve the performance of the catheter when used for hemodialysis (e.g., when fluid is being ejected from one lumen 122 and received by another lumen 122). For example, the catheter 100 can be used for hemodialysis treatment, in which the first lumen 122a is used as the suction line (withdrawing toxic blood) and the second lumen 122b is used as the return line (returning treated blood). It should be noted that the first lumen 122a can be used as the return line while the second lumen 122b is used as the suction line. The configuration of the catheter tip 120, and in particular the ramp of the septum 124 within the beveled shape region 130 and the septum top surface 150 forming the eaves 152, 154, provides improved fluid flow (an increase in the amount and rate of toxic blood being withdrawn via one lumen orifice 172 and an increase in the amount and rate of treated blood being introduced via another lumen orifice 172) with reduced undesired recirculation (i.e., a decrease in the amount and rate of treated blood being introduced via the return line that is undesirably withdrawn via the suction line). The eaves 152, 154 act as baffles to direct fluid flow out from the lumen 122 via the lumen orifice 172, while restricting cross-over fluid flow, thereby reducing undesired recirculation. For example, blood exiting the first lumen 122a via the first lumen orifice 172a is significantly restricted by the eaves 152, 154 so as to not flow into the path of the second lumen 122b and be entrained within the suction force of the second lumen 122b. This can result in a significant reduction of treated blood being withdrawn back via the second lumen orifice 172b throughout the hemodialysis treatment. This result can improve reliability and efficiency of the hemodialysis treatment. Additional improvements in fluid flow are achieved by limiting the catheter tip 120 to the angles (angle A.sub.1 and angle A.sub.2), the major axes and minor axes dimensions, and the ratios of the dimensions disclosed herein. In addition, embodiments of catheter 100 having a plane of mirror symmetry coplanar with central longitudinal plane 126 improve fluid flow, as well as provide for self-dilation. That is, embodiments of catheter 100 having improved fluid flow and which are capable of self-dilation can have mirror symmetry of the first lumen 122a with the second lumen 122b, mirror symmetry of the first lumen orifice 172a with the second lumen orifice 172b, and mirror symmetry of the first eave 152 with the second eave 154. In some embodiments, a third lumen 122c can be configured to facilitate insertion of a guidewire for easier manipulation of the catheter 100.

(48) In alternative embodiments, the catheter 500 can include a catheter body 502 having a catheter proximal end 504 and a catheter distal end 506 with a central longitudinal axis 508 extending from the catheter proximal end 504 to the catheter distal end 506. The catheter body 502 can be a tubular member made from plastic, silicone, rubber, etc. The catheter body 502 can have a catheter top 512, a catheter bottom 514, a catheter first side 516, and a catheter second side 518. The catheter proximal end 504 can be configured to connect to a pump, reservoir, or other device for providing means to cause fluid to flow into and out from the catheter 500.

(49) The catheter distal end 506 can be formed into a catheter tip 520. The catheter tip 520 can be configured to be inserted into a portion of a patient's body. For example, the catheter tip 520 can be tapered so as to facilitate spearheading the insertion of the catheter 500 into a patient's body, which may include insertion into a vein of the patient.

(50) The catheter tip 520 can have at least one aperture 510 extending through the catheter top 512 or the catheter bottom 514. In at least one embodiment, the catheter 500 can have at least one aperture 510 formed in a portion thereof. For example, the catheter 500 can have an aperture 510 formed in the catheter top 512. The aperture 510 can extend into at least one of the first lumen 522a and the second lumen 522b. For instance, the catheter 500 can have a first aperture 510 formed in the catheter top 512 that extends into the first lumen 522a. The catheter 500 can have a second aperture 510 formed in the catheter top 512 that extends into the second lumen 522b. Some embodiments can include at least one aperture 510 formed in the catheter bottom 514. The aperture 510 formed in the catheter bottom 514 can extend into at least one of the first lumen 522a and the second lumen 522b. For instance, the catheter 500 can have a first aperture 510 formed in the catheter bottom 514 that extends into the first lumen 522a, a second aperture 510 formed into the catheter bottom 514 that extends into the first lumen, a third aperture 510 formed in the catheter bottom 514 that extends into the second lumen 522b, and a fourth aperture 510 formed into the catheter bottom 514 that extends into the second lumen 522b.

(51) The catheter body 502 can include at least one lumen 522 extending through at least a portion of the catheter body 502. The lumen 522 can be formed in the catheter body 502 so that it extends from the catheter proximal end 504 to the catheter distal end 506. In some embodiments, at least a portion of the lumen 522 can extend along the central longitudinal axis 508. For example, the catheter body 502 can have a first lumen 522a extending from the catheter proximal end 504 to the catheter distal end 506 and having a first lumen upper orifice 572a.sub.1 and a first lumen lower orifice 572a.sub.2 at the catheter distal end 506. The catheter body 502 can have a second lumen 522b extending from the catheter proximal end 504 to the catheter distal end 506 and having a second lumen upper orifice 572b.sub.1 and a second lumen lower orifice 572b.sub.2 at the catheter distal end 506. The first lumen 522a can be adjacent the second lumen 522b. In some embodiments, the first lumen 522a can be separated from the second lumen 522b by a first septum 524. The first septum 524 can be formed between the first lumen 522a and the second lumen 522b so as to extend along a central portion of the catheter body 502 from the catheter proximal end 504 to the catheter distal end 506.

(52) FIG. 12 illustrates a perspective view, a top view, and a side view of the catheter tip 520. The catheter tip 520 can include a conical shaped region 530 at the distal end 506 of the catheter 500. The conical shaped region 530 can have a conical frustum shape having a flat distal edge 536. The flat distal edge 536 of the conical shaped region 530 can have a thickness, Th.sub.4.

(53) FIG. 13 illustrates perspective views (FIGS. 13A and 13B) and a front view (FIG. 13C) of the conical shaped region 530 of the catheter tip 520. FIG. 13A is oriented such that the septum top surface 550a is located at the top of FIG. 13A. FIG. 13B is a perspective view that is oriented 90 degrees clockwise relative to the view shown in FIG. 13A.

(54) First septum 524a can have a first septum first side 546a forming an inner portion of the first lumen 522a and a first septum second side 548a forming an inner portion of the second lumen 522b. For example, the first septum first side 546a can form at least part of the first lumen 522a and the first septum second side 548a can form at least part of the second lumen 522b.

(55) Second septum 524b can have a second septum first side 546b and a second septum second side 548b. Second septum 524b can extend from a proximal end of the conical shaped region to the distal end 506 of the catheter 500. Second septum 524b can bisect at least a portion of the first lumen 522a such that the first lumen 522a has a first lumen upper orifice 572a.sub.1 and a first lumen lower orifice 572a.sub.2. Second septum 524b can bisect at least a portion of the second lumen 522b such that the second lumen 522b has a second lumen upper orifice 572b.sub.1 and a second lumen lower orifice 572b.sub.2.

(56) Within the conical shaped region 530, the first septum 524a and the second septum 524b can have a plurality of surfaces. The first septum 524a can have a septum top surface 550a separating the first lumen upper orifice 572a.sub.1 from the second lumen upper orifice 572b.sub.1. The first septum 524a can have a septum bottom surface 550b separating the first lumen lower orifice 572a.sub.2 from the second lumen lower orifice 572b.sub.2. The second septum 524b can have a septum first lateral surface 550c separating the first lumen upper orifice 572a.sub.1 from the first lumen lower orifice 572a.sub.2. The second septum 524b can have a septum second lateral surface 550d separating the second lumen upper orifice 572b.sub.1 from the second lumen lower orifice 572b.sub.2.

(57) At least a portion of the first septum first side 546a can have an arcuate shape. For example, the portion of the first septum first side 546a leading up into the septum top surface 550a can be arched and the portion of the first septum first side 546a leading up into the septum bottom surface 550b can be arched. At least a portion of the first septum second side 548a can have an arcuate shape. For example, the portion of the first septum second side 548a leading up into the septum top surface 550a can be arched and the portion of the first septum second side 548a leading up into the septum bottom surface 550b can be arched.

(58) At least a portion of the second septum first side 546b can have an arcuate shape. For example, the portion of the second septum first side 546b leading up into the septum first lateral surface 550c can be arched and the portion of the second septum first side 546b leading up into the septum second lateral surface 550d can be arched. At least a portion of the second septum second side 548b can have an arcuate shape. For example, the portion of the second septum second side 548b leading up into the septum first lateral surface 550c can be arched and the portion of the second septum second side 548b leading up into the septum second lateral surface 550d can be arched.

(59) FIG. 13C illustrates a front view of the conical shaped region 530 of the catheter tip 520. The conical shaped region can have a plurality of lumen orifices. For example, the first lumen 522a can have a first lumen upper orifice 572a.sub.1 and a first lumen lower orifice 572a.sub.2. The second lumen 522b can have a second lumen upper orifice 572b.sub.1 and a second lumen lower orifice 572b.sub.2. The third lumen 522c can have a third lumen orifice 572c.

(60) A geometric plane along the central longitudinal axis 508 and extending from the catheter top 512 to the catheter bottom 514 defines a central longitudinal plane 526. A geometric plane along the central longitudinal axis 508, normal to the central longitudinal plane 526, and extending from the catheter first side 516 to the catheter second side 518 defines a central latitudinal plane 528.

(61) The septum top surface 550a and the septum bottom surface 550b can be bisected by central longitudinal plane 526. The half of the septum top surface 550a spanning from the central longitudinal plane 526 to the first lumen upper orifice 572a.sub.1 and the region of the first septum first side 546a leading up into the septum top surface 550a can be referred to as the first eave 552. The half of the septum top surface 550a spanning from the central longitudinal plane 526 to the second lumen upper orifice 572b.sub.1 and the region of the first septum second side 148a leading up into the septum top surface 550a can be referred to as the second eave 554. The half of the septum bottom surface 550b spanning from the central longitudinal plane 526 to the first lumen lower orifice 572a.sub.2 and the region of the first septum first side 546a leading up into the septum bottom surface 550b can be referred to as the third eave 576. The half of the septum bottom surface 550b spanning from the central longitudinal plane 526 to the second lumen lower orifice 572b.sub.2 and the region of the first septum second side 148a leading up into the septum bottom surface 550b can be referred to as the fourth eave 578.

(62) The septum first lateral surface 550c and the septum second lateral surface 550d can be bisected by central latitudinal plane 528. The half of the septum first lateral surface 550c spanning from the central latitudinal plane 528 to the first lumen upper orifice 572a.sub.1 and the region of the second septum first side 546b leading up into the septum first lateral surface 550c can be referred to as the fifth eave 580. The half of the septum first lateral surface 550c spanning from the central latitudinal plane 528 to the first lumen lower orifice 572a.sub.2 and the region of the second septum second side 148b leading up into the septum first lateral surface 550c can be referred to as the sixth eave 582. The half of the septum second lateral surface 550d spanning from the central latitudinal plane 528 to the second lumen upper orifice 572b.sub.1 and the region of the second septum first side 546b leading up into the septum second lateral surface 550d can be referred to as the seventh eave 584. The half of the septum second lateral surface 550d spanning from the central latitudinal plane 528 to the second lumen lower orifice 572b.sub.2 and the region of the second septum second side 148b leading up into the septum second lateral surface 550d can be referred to as the eighth eave 586.

(63) Each of the first eave 552 and the fifth eave 580 can have a curved or arched shape that forms at least a portion of the first lumen upper orifice 572a.sub.1. Each of the second eave 554 and the seventh eave 584 can have a curved or arched shape that forms at least a portion of the second lumen upper orifice 572b.sub.1. Each of the third eave 576 and the sixth eave 582 can have a curved or arched shape that forms at least a portion of the first lumen lower orifice 572a.sub.2. Each of the fourth eave and the eighth eave can have a curved or arched shape that forms at least a portion of the second lumen lower orifice 572b.sub.2.

(64) Each of the first eave 552 and the fifth eave 580 acts as a baffle to direct fluid flow out from the first lumen 522a via the first lumen upper orifice 572a.sub.1, while restricting cross-over fluid flow to the second lumen 522b, thereby reducing undesired recirculation. Each of the third eave 576 and the sixth eave 582 acts as a baffle to direct fluid flow out from the first lumen 522a via the first lumen lower orifice 572a.sub.2, while restricting cross-over fluid flow to the second lumen 522b, thereby reducing undesired recirculation. Each of the second eave 554 and the seventh eave 584 acts as a baffle to direct fluid flow out from the second lumen 522b via the second lumen upper orifice 572b.sub.1, while restricting cross-over fluid flow to the first lumen 522a, thereby reducing undesired recirculation. Each of the fourth eave 578 and the eighth eave 586 acts as a baffle to direct fluid flow out from the second lumen 522b via the second lumen lower orifice 572b.sub.2, while restricting cross-over fluid flow to the first lumen 522a, thereby reducing undesired recirculation.

(65) FIG. 14 illustrates a cross-section of catheter 500. The catheter body 502 can have a catheter top 512, a catheter bottom 514, a catheter first side 516, and a catheter second side 518. The catheter body 502 can have a generally circular shaped cross-section. The catheter body 502 can have a first lumen 522a extending from the catheter proximal end 504 to the catheter distal end 506, a second lumen 522b extending from the catheter proximal end 504 to the catheter distal end 506, the first lumen 522a being adjacent the second lumen 522b, the first lumen 522a being separated from the second lumen 522b by a first septum 524a. The first septum 524a can extend along the central longitudinal plane 526 from the catheter proximal end 504 to the catheter distal end 506. The catheter body 502 can have a third lumen 522c extending from the catheter proximal end 504 to the catheter distal end 506. The third lumen 522c can be positioned adjacent the first lumen 522a and adjacent the second lumen 522b. The third lumen 522c can have a generally circular shaped cross-section. The third lumen 522c can be positioned centrally within the catheter body 502 such that the third lumen 522c bisects the first septum 524a.

(66) Embodiments of catheter 500 disclosed herein are specifically designed to improve the performance of the catheter when used for hemodialysis (e.g., when fluid is being ejected from one lumen 522 and received by another lumen 522). For example, the catheter 500 can be used for hemodialysis treatment, in which the first lumen 522a is used as the suction line (withdrawing toxic blood) and the second lumen 522b is used as the return line (returning treated blood). It should be noted that the first lumen 522a can be used as the return line while the second lumen 522b is used as the suction line. The configuration of the catheter tip 520, and in particular the angle of the conical shaped region 530 and the septum surfaces 550a, 550b, 550c, and 550d forming the eaves 552, 554, 576, 578, 580, 582, 584, and 586, provides improved fluid flow (an increase in the amount and rate of toxic blood being withdrawn via one lumen orifice 572 and an increase in the amount and rate of treated blood being introduced via another lumen orifice 572) with reduced undesired recirculation (i.e., a decrease in the amount and rate of treated blood being introduced via the return line that is undesirably withdrawn via the suction line). The eaves 552, 554, 576, 578, 580, 582, 584, and 586 act as baffles to direct fluid flow out from the lumen 522 via the lumen orifices 572, while restricting cross-over fluid flow, thereby reducing undesired recirculation. For example, blood exiting the first lumen 522a via the first lumen upper orifices 572a is significantly restricted by the eaves 552, 576, 580, and 582 so as to not flow into the path of the second lumen 522b and be entrained within the suction force of the second lumen 522b. This can result in a significant reduction of treated blood being withdrawn back via the second lumen orifices 572b throughout the hemodialysis treatment. This result can improve reliability and efficiency of the hemodialysis treatment. In addition, embodiments of catheter 500 having a plane of mirror symmetry coplanar with the central longitudinal plane 526 and a plane of symmetry coplanar with the central latitudinal plane 528 improve fluid flow, as well as provide for self-dilation.

(67) In some embodiments, a third lumen 522c can be configured to facilitate insertion of a guidewire for easier manipulation of the catheter 500. The third lumen 522c can extend from the catheter proximal end 504 to the catheter distal end 506 and have a third lumen orifice 572c at the catheter distal end 506. The third lumen 522c can be positioned adjacent the first lumen 522a and adjacent the second lumen 522b. The third lumen 522c can have a generally circular shaped cross-section. The third lumen 522c can be positioned centrally within the catheter body 502 such that the third lumen 522c bisects the first septum 524a and bisects the second septum 524b.

Example 1—Recirculation Analysis

(68) Percent lumen-to-lumen recirculation was determined for an exemplary embodiment of the present disclosure shown in FIGS. 1-12, referred to as “13.5F Trio-CT” and for a traditional catheter referred to as “15.5F T-3.” Two catheter lengths were tested for each of the 13.5F Trio-CT and the 15.5F T-3 catheters. A total of 30 catheters were tested as follows:

(69) 10×13.5F Trio-CT 15 cm catheter,

(70) 10×13.5F Trio-CT 30 cm catheter,

(71) 5×15.5F T-3 15 cm catheter, and

(72) 5×15.5F T-3 32 cm catheter.

(73) Both normal and reverse flow re-circulation values were determined under a simulated use condition using saline. A two-head rotary pump was used with a flow rate of 2.5 L/min. For each of the 10 (traditional) 15.5F T-3 catheters, a single replicate experiment was conducted for each of the normal and reverse flow conditions. For each of the 20 13.5F Trio-CT catheters of the present disclosure, three replicate experiments were conducted for each of the normal and reverse flow conditions. For each condition and replicate, conductivity was measured in mili-Siemen (mS) for the water reservoir, the saline (venous) sample, and the collected (arterial) sample.

(74) Percent recirculation was calculated using Formula 1 and averaged for replicate catheters and replicate experiments.
% Recirculation=[(Collected Fluid mS−Water Reservoir mS)/(Saline mS)]×100%  Formula 1:

(75) Averaged % Recirculation results are shown below in Table 1.

(76) TABLE-US-00001 TABLE 1 % Recirculation 13.5 F Trio-CT 15.5 F T-3 15 cm 30 cm 15 cm 32 cm Normal Reverse Normal Reverse Normal Reverse Normal Reverse Flow Flow Flow Flow Flow Flow Flow Flow Average 0.42 0.65 1.44 1.99 0.00 7.78 0.00 7.72 Max. 2.33 3.16 4.00 4.64 0.00 8.39 0.00 10.46

(77) Results from recirculation testing show that % recirculation is low for the traditional catheters (15.5F T-3 15 cm and 32 cm catheters) under normal flow conditions, but that % recirculation increases significantly under reverse flow for the traditional catheters. Unexpectedly, the catheters of the present disclosure (13.5F Trio-CT 15 cm and 30 cm catheters) show low % recirculation under both normal and reverse flow conditions.

(78) It should be understood that modifications to the embodiments disclosed herein can be made to meet a particular set of design criteria. For instance, the number of or configuration of catheters 100 and 500, lumen 122 and 522, septa 124 and 524, apertures 110 and 510, and/or other components or features may be used to meet a particular objective.

(79) It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teachings of the disclosure. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternative embodiments may include some or all of the features of the various embodiments disclosed herein. Therefore, it is the intent to cover all such modifications and alternative embodiments as may come within the true scope of this disclosure, which is to be given the full breadth thereof. Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range, including the end points.

(80) Therefore, while certain exemplary embodiments of apparatuses and methods of making and using the same have been discussed and illustrated herein, it is to be distinctly understood that the disclosure is not limited thereto but may be otherwise variously embodied and practiced within the scope of the following claims.