# Patent

## Title
Catheter including arcuate transition region

## Abstract

A catheter, with one or more lumens, having a first portion and a second portion and an arcuate transition region extending between the first portion and the second portion. The first portion is nonparallel to the second portion.

## Background
CROSS-REFERENCE TO RELATED APPLICATION
This application claims the benefit of U.S. Provisional Application No. 60/744,094, entitled “CATHETER INCLUDING ARCUATE TRANSITION REGION AND/OR AT LEAST ONE TRANSFORMATION REGION,” filed Mar. 31, 2006, which is incorporated herein by reference in its entirety.


BACKGROUND
Embodiments described herein are related to a catheter suitable for insertion into a vein of a patient. A catheter is a conduit or tube that is inserted into a body cavity, duct or blood vessel. Catheters may be used for various processes in which bodily fluids, medicaments, or other solutions are introduced and removed from the body, such as perfusion, infusion, apheresis, hemodialysis, chemotherapy, or other processes known in the art.
SUMMARY
In one embodiment, a catheter includes a catheter body extending between a distal end and a proximal end and defining at least one lumen, a first portion and a second portion, and an arcuate transition region extending between the first portion and the second portion, such that the arcuate transition region is configured to be at or near an insertion site into the body of a patient, the arcuate transition region including an exterior angle greater than 180 degrees.
In another embodiment, a catheter includes a catheter body extending between a distal end and a proximal end and defining two lumens, a first portion and a second portion, and an arcuate transition region extending between the first portion and the second portion; wherein at least a majority of the first portion is configured to be disposed outside the body of a patient and, wherein at least a segment of the second portion has a length suitable for insertion inside the body of the patient, and wherein the exterior angle between a central axis of the first portion and a central axis of the second portion is greater than 180 degrees.
In another embodiment, a catheter includes a catheter body extending between a distal end and a proximal end and defining at least two lumens, a first portion and a second portion, and an arcuate transition region extending between the first portion and the second portion, wherein the arcuate transition region includes an exterior angle greater than 180 degrees, at least one transformation region between the first portion and the second portion within which the position of a septum dividing the two lumens at least partially changes, and a separation angle formed between a central axis of the first portion and a central axis of the second portion, wherein the separation angle is no more than about 90 degrees.



BRIEF DESCRIPTION OF THE DRAWINGS
Understanding that drawings depict only typical embodiments of the disclosure and are not therefore to be considered to be limiting of its scope, the present embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings as listed below.
FIG. 1 shows a perspective view of one embodiment of a catheter including an arcuate transition region.
FIG. 2 shows a bottom elevation view of the catheter shown in FIG. 1.
FIG. 3 shows a side view of the catheter shown in FIGS. 1 and 2.
FIG. 4 shows a perspective view of the arcuate transition region of the catheter shown in FIGS. 1-3.
FIG. 5 shows another embodiment of a catheter including an arcuate transition region.
FIG. 6 shows a top elevation view of the catheter shown in FIG. 5.
FIG. 7 shows a cross-sectional view of the catheter shown in FIGS. 5 and 6.
FIG. 8 shows a top elevation view of one embodiment of a catheter including at least one transformation region.
FIGS. 9-11 show different cross-sectional views of one embodiment of the catheter shown in FIG. 8.
FIGS. 12 and 13 show different cross-sectional views of another embodiment of the catheter shown in FIG. 8.
FIG. 14 shows a top elevation view of one embodiment of a catheter including a plurality of transformation regions.
FIGS. 15-19 show different cross-sectional views of one embodiment of the catheter shown in FIG. 14.
FIG. 20 shows one embodiment of a catheter including an arcuate transition region and at least one transformation region.
FIG. 21 shows a top elevation view of the catheter shown in FIG. 20.
FIG. 22 shows a top elevation view of another embodiment of a catheter according to the instant disclosure.
FIG. 23 shows a top elevation view of a further embodiment of a catheter according to the instant disclosure.



DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
Generally, one aspect of the instant disclosure relates to a catheter including an arcuate transition region. Another aspect of the instant disclosure relates to a transformation region within which an orientation of at least one lumen comprising the catheter changes. In addition, a catheter including an arcuate transition region and/or at least one transformation region may include at least one proximal connection structure for facilitating fluid communication with an associated lumen of the catheter and at least one distal leg or portion.
The relative term “distal” refers to those portions of a catheter and those portions of components of the catheter that are nearer, relatively, to an insertion end of the catheter, that is, the end of the catheter that is inserted into an area of a patient's body, such as a blood vessel. In addition, the relative term “proximal” refers to those portions of a catheter and those portions of components of the catheter that are farther, relatively, from the insertion end of the catheter. In one aspect of the instant disclosure, a distal portion of the catheter may cross over or intersect with a proximal portion of the catheter. In addition, optionally, a selected exterior angle may be formed between a central axis of a first portion of the catheter and a central axis of a second portion of the catheter.
As mentioned above, one aspect of the instant disclosure relates to a catheter including an arcuate transition region. Such a catheter may be used for various processes in which bodily fluids, medicaments, or other solutions are introduced and removed from the body, such as perfusion, infusion, apheresis, hemodialysis, chemotherapy, or other processes known in the art. For example, a catheter may be utilized for a hemodialysis catheterization, such as the internal jugular vein catheterization. However, it should be understood by one skilled in the art based on this disclosure, that a catheter can be structured (e.g., increasing or decreasing the catheter size and/or shape, changing a number of lumens defined by the catheter, selecting materials comprising a catheter, etc.) such that the catheter can be beneficially used for a selected medical application in which fluids are introduced and/or removed from the body.
For example, FIG. 1 shows a perspective view of one embodiment of a catheter 10 encompassed by the instant disclosure. As shown in FIG. 1, the catheter 10 extends between a distal end 50 for insertion into a patient and a proximal end 51. As known in the art, optionally, catheter 10 may include a stabilizing cuff affixed to an outer portion of the body of the catheter at a selected longitudinal position such that the cuff will be ultimately positioned within a subcutaneous tunnel formed in the patient. The catheter 10 may also optionally include a hub structure 20 and a clamp device 19. In one embodiment, as discussed in greater detail below, proximal end 51 may include a connector 12 configured for connection to a device used to introduce or remove fluid from at least one lumen of the catheter 10. In further detail, catheter 10 comprises a catheter body including a first portion 70, a second portion 80, and an arcuate transition region 90 extending between the first portion 70 and the second portion 80.
In one embodiment, the arcuate transition region 90 is configured to be at or near an insertion site into the body of a patient. The arcuate transition region 90 near the insertion site indicates that it is located at a position adjacent or close to the location where the catheter enters the body of a patient. The arcuate transition region near the insertion site can be located adjacent to the insertion site on either the interior of the body or the exterior of the body. For example, in one exemplary embodiment the arcuate transition region near the insertion site may be disposed within the body at a location within 5 cm of the insertion site. One having skill in the art would appreciate that “near the insertion site” is a relative term and may depend, in part, on the size of the arcuate region and the catheter used.
In one embodiment, at least a majority of the first portion 70 is configured to be disposed outside the body of a patient and at least a segment of the second portion 70 has a length suitable for insertion inside the body of the patient. In yet another embodiment, the distal end 50 may include a non-helical terminus. In one embodiment, catheter 10 may comprise one or more lumens.
Generally, the instant disclosure contemplates that arcuate transition region 90 may be structured so that first portion 70 is nonparallel with respect to second portion 80. FIG. 2 shows a bottom elevation view of catheter 10 that shows first portion 70 in relation to second portion 80. More particularly, as shown in FIG. 2, a selected exterior angle may be formed between the first portion 70 and the second portion 80, when the catheter 10 is in a substantially unstressed state.
In one embodiment, an exterior angle formed between the first portion 70 and the second portion 80 may exceed 180°. For example, the angle formed between the first portion 70 and the second portion 80 may range from approximately 180-190°, 190-200°, 200-210°, 210-220°, 220-230°, 230-240°, 240-250°, 250-260°, and 260-270°. In yet another embodiment, an exterior angle formed between the first portion 70 and the second portion 80 may be less than 180°. For example, the angle formed between the first portion 70 and the second portion 80 may range from approximately 0-10°, 10-20°, 20-30°, 30-40°, 40-50°, 50-60°, 60-70°, 70-80°, 80-90°, 100-110°, 110-120°, 120-130°, 130-140°, 140-150°, 150-160°, 160-170°, and 170-180°. More particularly, an exterior angle between the first portion 70 and the second portion 80 may be about 225°.
The instant disclosure generally contemplates, without limitation, that the exterior angle may be measured between any surfaces of the first portion 70 and/or the second portion 80. Variations (i.e., increases or decreases) in the magnitude of a measurement of an exterior angle due to a thickness or size of the first portion 70 and/or the second portion 80 are encompassed by the above-discussed exterior angle embodiments. One of ordinary skill in the art will appreciate that at least a portion of arcuate transition region 90 may form a generally circular arc. The instant disclosure further contemplates that, in other embodiments, at least a portion of arcuate transition region 90 may comprise at least one of the following: a generally elliptical arc, a generally parabolic curve, and a generally concave curve.
In one embodiment, an exterior angle may be measured between a central axis of the first portion 70 and a central axis of the second portion 80. For example, angle θ is shown in FIG. 2 extending between a central axis 63 extending along first portion 70 (e.g., along a centroid of a cross-sectional area of the first portion 70) and a central axis 41 extending along second portion 80 (e.g., along a centroid of a cross-sectional area of the second portion 80). Thus, a selected angle θ may be formed between central axis 63 of first portion 70 and central axis 41 of second portion 80, when arcuate transition portion 90 of catheter 10 is in a substantially unstressed state. In one embodiment, as shown in FIG. 2, exterior angle θ may exceed 180°. In one embodiment, exterior angle θ may be about 225°. Further, central axis 63 may cross or intersect with central axis 41 (e.g., for a given reference plane, as shown in the exemplary bottom elevation view of FIG. 2).
In addition, the instant disclosure also contemplates that, optionally, an arcuate transition region of a catheter may form a separation angle between a first portion of a catheter and a second portion of a catheter that are connected by an arcuate transition region. More specifically, FIG. 3 shows a side view of the catheter 10 shown in FIGS. 1 and 2, wherein a separation angle λ is formed generally between first portion 70 and second portion 80 of catheter 10. In one embodiment, separation angle λ may be no more than about 90°. More specifically, separation angle λ may be approximately 10° or less.
One of ordinary skill in the art will appreciate that a catheter including an arcuate transition region may include one or both of a selected exterior angle and a selected separation angle. Put another way, an exterior angle and a separation angle may be employed in combination or may be employed separately, without limitation. One of ordinary skill in the art will appreciate that, in one embodiment of a catheter comprising both a separation angle and an exterior angle, at least a portion of arcuate transition region 90 may be substantially helical. FIG. 4 shows a perspective view of arcuate transition region 90, wherein arcuate transition region 90 is substantially helical.
Such a configuration may provide a catheter that is more comfortable and easier to secure to a patient. Additionally or optionally, such a unique shape may act to stabilize the catheter within the tunnel/venotomy region and may prevent pistoning and migration of the catheter prior to tissue ingrowth. Since the transition or path from tunnel track into vein is generally three dimensional and tortuous in nature such a catheter including an arcuate transition region may contour more closely to this transition or path.
In further detail, an arcuate transition region may be capable of handling even relatively tight curves. For example, the catheter can be more easily “rolled” by the doctor prior to placement to adjust where the distal end will end up. As a further note, the catheter may comprise a material (e.g., polyurethane) that significantly softens at body temperature. Thus, in one embodiment, the shape of the catheter may not generate residual stresses (i.e., outward forces) exceeding forces generated by a conventional (e.g., U-shaped) catheters. Conventional catheters are disclosed in U.S. Pat. No. 5,509,897 to Twardowski et al.
In another embodiment, a catheter may comprise a catheter body extending between a distal end and a proximal end and defining a plurality of lumens. Further, the distal end may comprise a plurality of distal end regions that extend generally from a junction region of the catheter body. In addition, the proximal end may comprise a plurality of proximal extension legs. In general, the instant disclosure contemplates, as discussed above, that such a catheter may include an arcuate transition region extending between the first portion and the second portion of the catheter.
For example, FIGS. 5 and 6 show a perspective view and a top elevation view, respectively, of a catheter 110 including distal end regions 132 and 134 (generally at a distal end 150 of the catheter 110) and proximal extension legs 108 and 106 (generally at a proximal end 151 of the catheter). Further, catheter 110 may include a proximal connection structure comprising a proximal end 151 of catheter 110. More particularly, couplings 112 and 114 may each comprise a luer-lock type coupling or other threaded or releasable fluid coupling structure as known in the art. As shown in FIG. 6, the hub structure 120 and proximal extension legs 108 and 106 may be suitably configured to establish a selected separation between the couplings 112 and 114 of proximal extension legs 108 and 106. Such a configuration may facilitate coupling of the catheter 110 to a fluid conveying or processing device, (e.g., dialysis equipment). As known in the art, hub structure 120 may facilitate fluid connection between proximal extension legs 108 and 106 and respective lumens defined by catheter 110. Further, the hub structure 120, as shown in FIGS. 5 and 6 may optionally include suture wings 121, which may be used to suture the catheter 110 to the patient for positioning of the catheter 110 after insertion into the patient.
Optionally, at least one of distal end regions 132 and 134 as well as one or more of proximal extension legs 108 and 106 and/or one or more of couplings 112 and 114, may include a visual or palpable indicator (e.g., a marking, a color, a symbol, a raised or indented feature, etc.) to indicate correspondence upon connection of catheter 110 to a fluid moving device. Also, each of proximal extension legs 108 and 106 may optionally include a clamp device, such as clamp devices 119 and 117, for clamping one or both of the proximal extension legs 108 and 106 when the catheter 110 is not connected to a fluid conveying device or when fluid flow through one or both of proximal extension legs 108 and 106 is not desired.
As shown in FIGS. 5 and 6, catheter 110 comprises a first portion 170, a second portion 180, and an arcuate transition region 190 extending between the first portion 170 and the second portion 180. Catheter 110 may comprise two lumens, wherein each of the lumens extends between one of proximal extension legs 106 or 108 and an associated one of distal end regions 132 or 134. More particularly, catheter 110 may include a first distal end region 132 and a second distal end region 134, each extending distally from a junction region 154. As shown in FIGS. 5 and 6, the second distal end region 134 may be shorter in length (e.g., measured from junction region 154) than a length (e.g., measured from junction region 154) of the first distal end region 132.
One of ordinary skill in the art will understand that proximal extension legs 106 and 108 in combination with couplings 112 and 114, respectively, may be used to connect catheter 110 to a fluid processing or fluid moving device (e.g., a medicine pump, a dialysis machine, etc.). Further, one of ordinary skill in the art will also understand that the first distal end region 132 may be used to remove fluid from a patient (e.g., as a venous extension leg in a hemodialysis application) and second distal end region 134 may be used to introduce fluid into a patient (e.g., as an arterial extension leg in a hemodialysis application). Additionally, the instant disclosure contemplates that the second distal end region 134 may be used to remove fluid from a patient (e.g., as a venous extension leg in a hemodialysis application) and first distal end region 132 may be used to introduce fluid into a patient (e.g., as an arterial extension leg in a hemodialysis application), if desired, without limitation.
The instant disclosure contemplates that arcuate transition region 190 may be configured, as discussed above in relation to any feature or aspect discussed above relative to arcuate transition region 90. Particularly, arcuate transition region 190 may be structured so that a first portion 170 is nonparallel with respect to a second portion 180.
FIG. 6 shows a top elevation view of catheter 110 that shows a selected exterior angle may be formed generally between the first portion 170 and the second portion 180, when the catheter 110 is in a substantially unstressed state. In one embodiment, an exterior angle formed between the first portion 170 and the second portion 180 may exceed 180°. In another embodiment, an exterior angle may be about 225°.
In one embodiment, an exterior angle formed between the first portion 170 and the second portion 180 may exceed 180°. For example, the angle formed between the first portion 170 and the second portion 180 may range from approximately 180-190°, 190-200°, 200-210°, 210-220°, 220-230°, 230-240°, 240-250°, 250-260°, and 260-270°. In yet another embodiment, an exterior angle formed between the first portion 170 and the second portion 180 may be less than 180°. For example, the angle formed between the first portion 170 and the second portion 180 may range from approximately 0-10°, 10-20°, 20-30°, 30-40°, 40-50°, 50-60°, 60-70°, 70-80°, 80-90°, 100-110°, 110-120°, 120-130°, 130-140°, 140-150°, 150-160°, 160-170°, and 170-180°. More particularly, an exterior angle between the first portion 170 and the second portion 180 may be about 225°. Further, one of ordinary skill in the art will appreciate that at least a portion of arcuate transition region 190 may comprise at least one of the following: a substantially circular arc, an elliptical arc, a parabolic curve, and a concave curve.
In addition, the instant disclosure generally contemplates, without limitation, that an exterior angle may be measured between any surfaces of the first portion 170 and/or the second portion 180, and such an exterior angle encompasses variations (i.e., increases or decreases) in the magnitude of the exterior angle due to a thickness or size of the first portion 170 and/or the second portion 180.
In one embodiment, an exterior angle may be measured between a central axis of the first portion 170 and a central axis of the second portion 180. For example, exterior angle θ is shown in FIG. 6 extending between a central axis 163 extending along first portion 170 (e.g., along a centroid of a cross-sectional area of the first portion 170) and a central axis 141 extending along the second portion 180 (e.g., along a centroid of a cross-sectional area of the second portion 180). Thus, a selected exterior angle θ may be formed between central axis 163 of first portion 170 and central axis 141 of second portion 180, when arcuate transition portion 190 is in a substantially unstressed state.
In one embodiment, exterior angle θ may exceed 180°. In another embodiment, exterior angle θ may be about 225°. Further, central axis 163 may cross or intersect with central axis 141 (e.g., for a given reference plane, as shown in the exemplary bottom elevation view of FIG. 6). In addition, arcuate transition region 190 of catheter 110 may form a separation angle (as discussed above relative to catheter 10) measured between first portion 170 and second portion 180 of catheter 110. In one embodiment, such a separation angle may be from approximately 0-90°. More particularly, a separation angle may be about 10° or less. Further, one of ordinary skill in the art will appreciate that a catheter including an arcuate transition region, in one embodiment, may comprise both a separation angle and an exterior angle. For example, in one embodiment, at least a portion of arcuate transition region 190 may be substantially helical.
Optionally, the first distal end region 132 may include one or more apertures formed through the first distal end region 132 in fluid communication with a lumen of catheter 110. Similarly, the second distal end region 134 may include one or more apertures in fluid communication with a lumen of catheter 110. Such one or more apertures formed through one or both first distal end region 132 and second distal end region 134 may facilitate fluid flow into or from the distal end regions 132 and 134.
FIG. 7 shows a cross-sectional view of the catheter shown in FIG. 6, taken along reference line 7-7. Direction V, as shown in FIG. 7, denotes the direction from which catheter 110 is viewed in FIG. 6. As shown in FIG. 7, the portion of catheter 110 extending generally between hub structure 120 and junction region 154 may include two lumens, such as lumens 202 and 204, exhibiting a generally semicircular (e.g., a generally D-shaped) cross-sectional shape. In one embodiment, a septum 205 may comprise a membrane extending (e.g., diametrically) across a generally circular tube or lumen. In one embodiment, the cross-sectional shape shown in FIG. 7 may extend along catheter 110 substantially uniformly (i.e., substantially unchanging in orientation) along the length of catheter 110 between hub structure 120 and junction region 154. One of ordinary skill in the art will appreciate that the shape and cross-section configuration of any of the lumens of the catheter or extension legs may be varied, and, thus, the scope of the instant disclosure should not be limited to the above-described embodiments.
In another aspect of the instant disclosure, an orientation of a lumen may change along the length of at least a portion of a catheter. For example, a catheter may include at least one region within which an orientation of a lumen changes. Particularly, FIG. 8 shows a top elevation view of a catheter 111. In one embodiment, catheter 111, as shown in FIG. 8, may comprise a curved region 230. In other embodiments, catheter 111 may comprise an arcuate transition region as previously described, or may be substantially straight or linear, if desired. In addition, catheter 111 may include a proximal connection structure comprising a proximal end 151 including couplings 112 and 114 as described previously with respect to FIG. 6. Thus, hub structure 120 and extension legs 108 and 106 may be configured to establish a selected separation between the couplings 112 and 114 of proximal extension legs 108 and 106. Hub structure 120 may facilitate fluid connection between proximal extension legs 108 and 106 and respective lumens defined by catheter 111. Also, each of proximal extension legs 108 and 106 may optionally include a clamp device, such as clamp devices 119 and 117.
Further, catheter 111 may include a transformation region 220, within which an orientation of a lumen at least partially changes. More particularly, FIGS. 9-11 show cross-sectional views of catheter 111, taken at reference lines 9-9, 10-10, and 11-11, respectively. More specifically, FIGS. 9-11 show lumens 202 and 204 and septum 205. Direction V, as shown in FIGS. 9-11, denotes the direction from which catheter 111 is viewed in FIG. 8. In one embodiment, lumens 202 and 204, as shown in FIG. 8, may be generally unchanged between hub structure 120 and transformation region 220. Also, in one embodiment, lumens 202 and 204, as shown in FIG. 11, may be generally unchanged between transformation region 220 and junction region 154. As shown in FIG. 8, a coupler 222 may optionally operably connect transformation region 220 to an adjacent portion of catheter 111. Such a configuration may ease manufacturing of catheter 111.
Within transformation region 220, the orientation of lumens 202 and 204 may change between respective orientations shown in FIGS. 9 and 11. More specifically, as shown in FIG. 10, lumens 202 and 204 (and septum 205) may be rotated in a counter-clockwise (CCW) direction with reference to a distal direction along catheter 111 within transformation region 220. In other words, the position of the septum 205 may at least partially change within transformation region 220. In one embodiment, septum 205 may smoothly and continuously rotate along a distal direction within catheter 111, such as in a screw or twist transformation, wherein the angle of rotation is proportional to the distal translation at any position within transformation region 220. Lumens 202 and 204 as well as septum 205 may be otherwise transformed, abruptly or gradually, between the cross section shown in FIG. 9 and the cross section shown in FIG. 11, without limitation.
In another embodiment, lumens 202 and 204, and septum 205, may rotate in a clockwise direction relative to a distal direction within transformation region 220 between the orientations shown in FIGS. 9 and 11. More specifically, as shown in FIG. 12, lumens 202 and 204, and septum 205, may be rotated in a clockwise direction (CW) with reference to a distal direction along catheter 111 within transformation region 220. In one embodiment, septum 205 may smoothly and continuously rotate along a distal direction within catheter 111, such as in a screw or twist transformation, wherein the angle of rotation is proportional to the distal translation at any position within transformation region 220. In one embodiment, the relative difference in the position of septum 205 shown in FIG. 9 and the position of septum 205 shown in FIG. 11 may be about 90°. In other embodiments, a difference in position of septum 205 may be any selected angle, such as an angle up to about 360°, or greater than 360°, without limitation.
A catheter including at least one transformation region may exhibit at least one selected mechanical property (e.g., a flexibility, moment of inertia, strength, etc.). Also, one of ordinary skill in the art will appreciate that position of septum 205, as shown in FIG. 11 or FIG. 13, may be beneficial for resisting kinking and/or reducing the cross-sectional area of a selected region of the catheter. In one embodiment, septum 205 may be aligned with a plane of bending, such as a plane in which bending deflections occur. Thus, in one embodiment, a neutral axis of the septum during bending may lie within a cross-sectional area of the septum, similar to a web of an I-beam in pure bending. One of ordinary skill in the art will understand that in such a configuration, a moment of inertia of the septum may be generally maximized with respect to bending in the plane of bending. Thus, septum 205 may resist bending, and reduce deflection or deformation of the catheter 111, to a degree exceeding an identical septum oriented transverse to a plane of bending or otherwise oriented. Such a configuration may inhibit deformation of the catheter 111 and may resist deformation that causes one or more of lumens 202 and 204 to become smaller in cross-sectional area.
In a further embodiment, a catheter may include a plurality of transformation regions. For example, FIGS. 14-19 show a perspective view and several cross-sectional views of a catheter 101 including transformation regions 220 and 240. Generally, catheter 101 may be as described previously in relation to catheter 111. More particularly, within transformation region 220, lumens 202 and 204 may generally rotate clockwise, shown as CW in FIG. 16, between the orientation shown in FIG. 15 and the orientation shown in FIG. 17 (i.e., about 90°). In addition, catheter 101 further includes transformation region 240. As shown in FIGS. 18 and 19, lumens 202 and 204 of catheter 101 may generally rotate counter-clockwise, shown as CCW in FIG. 18, within region 240, between the orientation shown in FIG. 17 and the orientation shown in FIG. 19 (i.e., about 90°). Thus, proximal extension leg 106 may be in fluid communication with second distal end region 134 via lumen 202. Further, proximal extension leg 108 may be in fluid communication with first distal end region 132 via lumen 204. The instant disclosure contemplates that a catheter including at least one transformation region may include any lumen configuration, such as one or more lumens exhibiting a selected size and shape as known in the art, without limitation.
The instant disclosure further encompasses any combination of features or attributes described above. For example, in one embodiment, a catheter may include an arcuate transition region and at least one transformation region. More particularly, FIGS. 20 and 21 show a perspective view and a top elevation view of catheter 301, which includes arcuate transition region 190 as well as transformation regions 220 and 240. In one embodiment, transformation region 220 may comprise lumens 202 and 204 as shown in FIGS. 15-17. More specifically, lumens 202 and 204 may rotate within transformation region 220 between the orientation shown in FIG. 15 and the orientation shown in FIG. 17 (e.g., about 90°). Further, in one embodiment, transformation region 240 may include lumens 202 and 204 as shown in FIGS. 17-19. Particularly, lumens 202 and 204 may rotate within transformation region 240 between the orientation shown in FIG. 17 and the orientation shown in FIG. 19 (e.g., about 90°). Accordingly, proximal extension leg 106 may be in fluid communication with second distal end region 134 via lumen 202 and proximal extension leg 108 may be in fluid communication with first distal end region 132 via lumen 204.
While aspects of the instant disclosure are described in relation to one embodiment of a catheter comprising two lumens, the instant disclosure is not so limited and other embodiments and catheter configurations are encompassed by the instant disclosure. For example, a catheter defining a plurality of lumens may comprise a plurality of substantially concentric tubes of varying diameter. In a further embodiment, a catheter may comprise three (or more) lumens. Generally, any lumen configuration known in the art may be utilized in combination with at least one of the following: an arcuate transition region and at least one transformation region. In addition, any distal tip structure as known in the art may comprise a catheter including at least one of the following: an arcuate transition region and at least one transformation region.
For example, any distal tip structure, such as a so-called “stepped-tip,” “split-tip,” or any catheter distal tip structure as known in the art, without limitation, may be included by a catheter comprising at least one of the following: an arcuate transition region and at least one transformation region. For example, in one embodiment, a catheter may include a so-called “stepped tip.” More particularly, FIG. 22 shows a catheter 303, which generally comprises components as described with respect to FIGS. 5 and 6. However, catheter 303 included a distal tip structure 250 including an extending end region 232 and a recessed region 235. As known in the art, an aperture 237 may be formed to communicate with at least one of the lumens of catheter 303. Thus, FIGS. 21 and 22 show respective catheters 301 and 303 comprising different distal tip configurations.
In a further aspect of the instant disclosure, one of ordinary skill in the art will appreciate that a transition region of a catheter may extend between a first portion and second portion of a catheter in a variety of ways. For instance, by way of illustration, FIG. 22 shows an arcuate transition region 190 extending from first portion 170, in a generally clockwise direction, toward second portion 180. In another embodiment, FIG. 23 shows a catheter 305, which generally comprises components as described with respect to FIG. 22, wherein an arcuate transition region 190 extends from first portion 170, in a generally counter-clockwise direction, toward second portion 180.
Without further elaboration, it is believed that one skilled in the art can use the preceding description to utilize the present disclosure to its fullest extent. The examples and embodiments disclosed herein are to be construed as merely illustrative and not a limitation of the scope of the present disclosure in any way. It will be apparent to those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the disclosure described herein. In other words, various modifications and improvements of the embodiments specifically disclosed in the description above are within the scope of the appended claims.

## Claims

1. A catheter comprising:
a catheter body extending between a distal end and a proximal end and defining at least one lumen, the catheter body including:
a first straight portion, a second straight portion, and an arcuate transition region extending in a continuous helical curve for more than a half revolution between the first straight portion and the second straight portion, the first straight portion crossing the second straight portion for a given reference plane, the arcuate transition region positioned at or near an insertion site into a body of a patient during catheter use.

2. The catheter of claim 1, wherein the helical curve of the arcuate transition region traverses about 225°.

3. The catheter of claim 1, wherein a separation angle between 0° and 90° is formed between a central axis of the first portion and a central axis of the second portion.

4. The catheter of claim 1, wherein the catheter body defines at least two lumens.

5. The catheter of claim 4, wherein the distal end of the catheter body comprises a venous extension leg including a first lumen, and an arterial extension leg including a second lumen.

6. The catheter of claim 4, wherein the first straight portion and the second straight portion are separated by at least one transformation region within which a position of a septum dividing the at least two lumens at least partially changes.

7. The catheter of claim 6, wherein the position of the septum changes in a clockwise direction relative to a distal direction along the catheter.

8. The catheter of claim 6, wherein the position of the septum changes in a counter-clockwise direction relative to a distal direction along the catheter.

9. The catheter of claim 6, wherein the position of the septum changes up to about 360°.

10. The catheter of claim 1, wherein the proximal end of the catheter body comprises at least one connector.

11. The catheter of claim 10, wherein the proximal end of the catheter body comprises a first connector including a first lumen, and a second connector including a second lumen.

12. The catheter of claim 1, wherein at least a majority of the first straight portion is configured to be disposed outside the body of the patient and, wherein at least a segment of the second straight portion has a length suitable for insertion inside the body of the patient.

13. A catheter comprising:
a catheter body extending between a catheter body first end and a catheter body second end and defining two lumens in a Cartesian x-y-z coordinate system, the catheter body including:
a first portion extending from the catheter body second end along an x-axis in a positive direction to a first end of an arcuate transition region and a second portion extending from a second end of the arcuate transition region in a negative x and negative y direction to the catheter body first end, the arcuate transition region connecting the first portion to the second portion;
wherein, during use, at least a majority of the first portion is disposed outside of a body of a patient and, wherein at least a segment of the second portion has a length suitable for insertion inside the body of the patient; and
wherein an exterior arc angle between a central axis of the first portion and a central axis of the second portion is greater than 180° when the arcuate transition region is in a substantially unstressed state such that the first portion and the second portion have a common (x,y) coordinate point not at the catheter body first end or catheter body second end when a z axis of the x-y-z coordinate system is oriented parallel to a longitudinal axis of the arcuate transition region such that the arcuate transition region curls around the longitudinal axis.

14. The catheter of claim 13, wherein the catheter body first end includes a non-helical terminus.

15. The catheter of claim 13, wherein the first portion and the second portion are separated by at least one transformation region within which a position of a septum dividing the at least two lumens at least partially changes.

16. The catheter of claim 13, wherein a separation angle between 0° and 90° is formed between the central axis of the first portion and the central axis of the second portion in the z-direction.

17. The catheter of claim 13, wherein the exterior arc angle is about 225°.