Double-lumen catheter
A catheter is described. In one embodiment, the catheter includes: a shaft segment including a shaft segment uptake lumen and a shaft segment return lumen; and a distal end segment coupled to the shaft segment, the distal end segment including a distal end segment uptake lumen and a distal end segment return lumen, where the distal end segment central axis forms a non-zero angle with the shaft segment central axis when the catheter is in its unstressed configuration. In a second embodiment, the catheter includes: a shaft segment; and a distal end segment coupled to the shaft segment; where the uptake lumen distal end is terminated by a closed surface, further where the uptake lumen distal segment includes only one side hole. In a third embodiment, the catheter includes: an uptake lumen; and a return lumen; where at least a portion of the return lumen distal segment is helically coiled around the uptake lumen distal end.
This application claims the benefit of U.S. Provisional Application Ser. No. 60/210,294, filed Jun. 8, 2000, and entitled “Double-Lumen Catheters Used for Hemodialysis”.
FIELD OF THE INVENTIONThe present invention relates generally to catheters and, in particular, though not exclusively, to double-lumen catheters used for hemodialysis.
BACKGROUND OF THE INVENTIONHemodialysis catheters are conventionally large double-lumen catheters. Generally, the lumens must be large enough to support flow rates greater than 250 c c/min through each lumen. A hemodialysis catheter resides within a large vein within the body or within the right atrium of the heart. The end of the catheter placed into a patient's body is referred to as the distal end of the catheter, while the end connected to a dialysis machine is called the proximal end. Blood is withdrawn out of a vein via an uptake lumen of the catheter and into the dialysis machine. The uptake lumen is also referred to herein as the withdrawal lumen. The dialyzed blood is returned to the body via the return lumen. The uptake lumen has an uptake lumen hole (also referred to as an uptake lumen opening) for withdrawal of blood from the body. The uptake lumen hole is typically disposed at the distal end of the uptake lumen. Similarly, the return lumen has a return lumen hole for return of blood to the body. The return lumen hole is typically disposed at the distal end of the return lumen. The uptake and return lumen holes are generally spatially separated from each other, typically with the uptake lumen hole located proximal to the return lumen. This is usually accomplished by making the uptake lumen shorter than the return lumen. The above configuration of the uptake and return lumen holes minimizes the immediate redialysis of blood just returned to the body.
On occasion, prior art catheters, such as that shown in
Some of the available hemodialysis catheters address this problem by designing the uptake lumen to have several side holes.
However, this design, in which multiple side holes are present to prevent occlusion by adjacent walls, presents a drawback of its own. When any hemodialysis catheter is not in use, both lumens are filled (or “locked”) with an anticoagulant solution, typically concentrated heparin sulfate. This solution is intended to prevent blood clots from forming on or within the catheter's lumens. Such blood clots would occlude the lumens, leading to catheter failure. If the uptake lumen has multiple side holes, the anticoagulant solution leaks away at the catheter tip through these multiple side holes, causing an increased risk of blood clot formation on the catheter's tip, thus causing subsequent catheter failure.
A hemodialysis catheter whose uptake lumen consists of a single end hole will retain the anticoagulant solution. However, as detailed above, such a prior-art hemodialysis catheter retains a tendency to have its uptake lumen end hole aspirate against an adjacent wall and occlude the uptake lumen.
The intravenous portion of conventional hemodialysis catheters are linear in configuration. The lumens of such catheters run parallel to each other within a single, flexible silicon housing, with the lumens separated by a silicone septum.
Discussion of prior art catheters, such as those described above, can be found in U.S. Pat. No. 5,209,723, U.S. Pat. No. 5,947,953, and U.S. Pat. No. 6,001,079, which are incorporated by reference herein.
Accordingly, there is a need for a catheter that addresses the above disadvantages of prior art catheters.
SUMMARY OF THE INVENTIONThe present invention encompasses a catheter. In one embodiment, the catheter includes: a shaft segment, the shaft segment including a proximal end of the catheter and a shaft segment central axis, the shaft segment further including a shaft S segment uptake lumen and a shaft segment return lumen; a distal end segment coupled to the shaft segment, the distal end segment including a distal end of the catheter and a distal end segment central axis, the distal end segment further including a distal end segment uptake lumen and a distal end segment return lumen, where the distal end segment uptake and return lumens are coupled to the shaft segment uptake and return lumens, respectively; where the distal end segment central axis forms a non-zero angle with the shaft segment central axis when the catheter is in its unstressed configuration.
In a second embodiment, the catheter includes: a shaft segment, the shaft segment including a proximal end of the catheter and a shaft segment central axis; a distal end segment coupled to the shaft segment, the distal end segment including a distal end of the catheter and a distal end segment central axis; where the distal end segment central axis is parallel to the shaft segment central axis when the catheter is in its unstressed configuration, further where the distal end segment includes a return lumen and an uptake lumen having a return lumen distal end and an uptake lumen distal end, respectively, further where the uptake lumen distal end is terminated by a closed surface, further where the uptake lumen distal segment includes only one side hole.
In a third embodiment, the catheter includes: an uptake lumen including an uptake lumen shaft segment and an uptake lumen distal segment with an uptake lumen distal end; a return lumen including a return lumen shaft segment and a return lumen distal segment with a return lumen distal end; where the uptake lumen shaft segment is substantially parallel to the return lumen shaft segment, further where at least a portion of the return lumen distal segment is helically coiled around the uptake lumen distal end.
Catheter 400 includes an uptake lumen side hole 441 and a return lumen end hole 442 in the distal end segment 450. In catheter 400, uptake lumen side hole 441 is the only uptake lumen hole. Catheter 400 does not have any other uptake lumen side holes in addition to uptake lumen side hole 441. Additionally, catheter 400 does not include an uptake lumen end hole since the distal end of uptake lumen 440 is sealed i.e., the uptake lumen distal end is terminated by a closed surface. In other words, unlike catheter 100 (in FIG. 1), catheter 400 does not include an uptake lumen end hole. Catheter 400 can be inserted by a physician into a vein or the atrium of a patient such that the uptake lumen side hole 441 is oriented in a direction opposite that of the nearest wall to help prevent adherence of the lumen to a vein or atrium wall. Thus, uptake lumen side hole 441 is a directable uptake lumen hole, i.e., it can be directed away from a vessel or atrium wall. This addresses the problem associated with prior art catheters, such as that shown in
In one embodiment, the uptake lumen side hole 441 is directed away from a lateral wall of a vessel when the catheter is in the vessel. In one embodiment, the uptake lumen side hole 441 is medially oriented with respect to the lateral wall of the vessel.
Furthermore, since catheter 400 has only one uptake lumen hole, where the only uptake lumen hole is an uptake lumen side hole, it also addresses the problems associated with prior art catheters, such as that shown in
Accordingly, catheter 400 of the present invention addresses the disadvantages of the catheters 100 and 200 of the prior art. In other words, catheter 400 minimizes obstruction of uptake lumen caused by either adherence of the catheter to the side walls of a vein or atrium or by a rapid diffusion of anticoagulant solutions from the catheter when the catheter is not in use.
Angled distal end segment 550 includes both a portion of the uptake lumen and a portion of the return lumen. Three embodiments of the cross sectional view along line 3—3 in the distal end segment 550 are shown in
Angled distal end segment 550 includes a return lumen end hole 542 and an uptake lumen end hole 541 that is located proximally with respect to the return lumen end hole 542. Angled distal end segment 550 allows the uptake lumen end hole 541 of the uptake lumen of the catheter 500 to be directed away from the nearest vessel or atrium wall when the catheter is inserted into a patient. This helps prevent occlusion of the uptake lumen by the adjacent wall of the vein or right atrium. Furthermore, since catheter 500 includes only one uptake lumen hole it minimizes diffusion of anticoagulant solution from the catheter 500 when the catheter 500 is not in use.
In one embodiment, the uptake lumen end hole 541 is directed away from a lateral wall of a vessel when the catheter is in the vessel. In one embodiment, the uptake lumen end hole 541 is medially oriented with respect to the lateral wall of the vessel.
Distal end segment 650 includes an uptake lumen end segment 651 and a return lumen end segment 652. Uptake lumen end segment 651 and return lumen end segment 652 each comprise separate tubes. Uptake lumen end segment 651 has a central axis 661 that forms a non-zero angle Z with central axis 630. Thus, uptake lumen end segment 651 is angled with respect to the central axis 630. On the other hand, return lumen end segment 652 has a central axis 662 that is parallel to the central axis 630. Thus, return lumen end segment 652 is not angled with respect to the central axis 630. However, there is a non-zero angle Z between central axis 662 of the return lumen end segment 652 and central axis 661 of the uptake lumen end segment 651. Thus, the distal end segment central axis 655 is parallel to the central axis 661 of the uptake lumen end segment 651, and the return lumen end segment 652 is angled at an angle Z with respect to the uptake lumen end segment 651.
In catheter 600, the angle between central axis 661 and central axis 630 is the same as the angle between central axis 661 and central axis 662. In another embodiment, these angles may be different from each other. This may happen, for example, when there is a first non-zero angle A1 between central axis 662 and central axis 630 and a second non-zero angle A2 between central axis 661 and central axis 630, where A1 is not equal to A2.
Uptake lumen (and more specifically the uptake lumen end segment 651) includes an uptake lumen end hole 641. Similarly, return lumen (and more specifically the return lumen end segment 652) includes a return lumen end hole 642.
The angled uptake lumen end hole 641 can be directed away from the nearest vessel or atrium wall when the catheter is inserted into a patient. This reduces occlusion of the uptake lumen end hole 641 by the adjacent wall of the vein or right atrium as in the embodiment shown in FIG. 5. Furthermore, since catheter 600 includes only one uptake lumen hole it minimizes leakage of anticoagulant solution from the catheter 600 when the catheter 600 is not in use.
In one embodiment, the uptake lumen end hole 641 is directed away from a lateral wall of a vessel when the catheter is in the vessel. In one embodiment, the uptake lumen end hole 641 is medially oriented with respect to the lateral wall of the vessel.
Referring to
The distal end of the return lumen 702 corresponds to the distal end 720 of catheter 700. At the distal end 720, the return lumen 702 includes a return lumen end hole 742. As can be seen in
In
Angled distal end segment 950 includes both a portion of the uptake lumen and a portion of the return lumen. Three embodiments of the cross sectional view along line 10—10 in the distal end segment 950 are shown in
An additional factor that helps reduce occlusion of the uptake lumen in catheter 900 is the relative position of the uptake lumen, more specifically uptake lumen end hole 941, within catheter 900. As can be seen in
Double lumen catheters such as 400, 500, 600, 700, and 900 can be made of flexible plastic material such as silicone, but need not be made of silicone. Catheters 400, 500, 600, 700 and 900 in
In the above embodiments, the angle Y may, for example, be in the range of 5 to 60 degrees, 5 to 45 degrees, or 5 to 30 degrees. Similarly, the angle Z may, for example, be in the range of 5 to 60 degrees, 5 to 45 degrees, or 5 to 30 degrees. As noted above, catheters 400, 500, 600, 700 and 900 in
In the above description one lumen in each of the drawings has been referred to as an uptake lumen while the other lumen has been referred to as the return lumen. It is to be noted that the present invention may encompass embodiments in which the designation of uptake lumen and return lumen are the reverse of those in the above description.
While the present invention has been particularly described with respect to the illustrated embodiments, it will be appreciated that various alterations, modifications and adaptations may be made based on the present disclosure, and are intended to be within the scope of the present invention. While the invention has been described in connection with what are presently considered to be the most practical and preferred embodiments, it is to be understood that the present invention is not limited to the disclosed embodiment but, on the contrary, is intended to cover various modifications and equivalent arrangements included within the scope of the appended claims.
Claims
1. A hemodialysis catheter comprising:
- a shaft segment, said shaft segment including a proximal end of the catheter and a shaft segment central axis, wherein said shaft segment comprises a shaft segment uptake lumen and a shaft segment return lumen;
- a distal end segment coupled to the shaft segment, said distal end segment including a distal end of the catheter and a distal end segment central axis, wherein said distal end segment comprises a distal end segment uptake lumen and a distal end segment return lumen, further wherein said distal end segment uptake and return lumens are coupled to said shaft segment uptake and return lumens, respectively;
- wherein said distal end segment uptake lumen comprises a distal end segment uptake lumen central axis,
- said distal end segment return lumen comprises a distal end segment return lumen central axis, and
- said distal end segment central axis is parallel to said distal end segment uptake lumen central axis and forms a non-zero angle with the shaft segment central axis when said catheter is in its unstressed configuration whereby said uptake lumen can be directed away from an adjacent wall when the catheter is inserted into a patient.
2. The catheter of claim 1, wherein the non-zero angle is in the range of 5 to 60 degrees.
3. The catheter of claim 1, wherein the non-zero angle is in the range of 5 to 45 degrees.
4. The catheter of claim 1, wherein the non-zero angle is in the range of 5 to 30 degrees.
5. The catheter of claim 1, wherein said distal end segment uptake lumen and distal end segment return lumen comprise a distal end segment uptake lumen central axis and distal end segment return lumen central axis, respectively.
6. The catheter of claim 5 claim 1, wherein the distal end segment uptake lumen central axis and distal end segment return lumen central axis are both parallel to the distal end segment central axis.
7. The catheter of claim 5 claim 1, wherein the distal end segment uptake lumen central axis is parallel to the distal end segment central axis and forms a non-zero angle with the shaft segment central axis, and further wherein the distal end segment return lumen central axis is parallel to the shaft segment central axis.
8. The catheter of claim 5 claim 1, wherein the distal end segment uptake lumen central axis is parallel to the distal end segment central axis and forms a non-zero angle with the shaft segment central axis, and further wherein the distal end segment return lumen central axis forms a second non-zero angle with the shaft segment central axis.
9. The catheter of claim 1, wherein said distal end segment uptake lumen comprises an uptake hole and said distal end segment return lumen comprises a return hole.
10. The catheter of claim 9, wherein said uptake hole is located proximally with respect to the return hole.
11. The catheter of claim 9, wherein said uptake hole is directed away from a lateral wall of a vessel when the catheter is in the vessel.
12. The catheter of claim 9, wherein said shaft segment comprises a lateral side wall, further wherein said uptake hole is directed away from the lateral side wall such that a separation is maintained between a lateral wall of a vessel and said uptake hole when the catheter is in the vessel and the lateral side wall abuts the lateral wall of the vessel.
13. The catheter of claim 9, wherein said distal end segment return lumen comprises a return lumen end segment, further wherein said return lumen end segment maintains a separation between a medial wall of a vessel and said uptake hole when the catheter is in the vessel.
14. The catheter of claim 9, wherein said distal end segment return lumen comprises a return lumen end segment, further wherein said return lumen end segment shields the uptake hole from a medial wall of a vessel when the catheter is in the vessel.
15. The catheter of claim 11, wherein said uptake hole is medially oriented with respect to the lateral wall of the vessel.
16. The catheter of claim 1, wherein the catheter is comprised of a flexible plastic material.
17. A catheter comprising:
- a shaft segment, said shaft segment including a proximal end of the catheter and a shaft segment central axis;
- a distal end segment coupled to the shaft segment, said distal end segment including a distal end of the catheter and a distal end segment central axis;
- wherein said distal end segment central axis is parallel to the shaft segment central axis when said catheter is in its unstressed configuration, further wherein said distal end segment comprises a return lumen and an uptake lumen having a return lumen distal end and an uptake lumen distal end, respectively, further wherein the uptake lumen distal end is terminated by a closed surface, further wherein the uptake lumen distal segment includes only one side hole whereby leakage of anticoagulant solution can be minimized.
18. The catheter of claim 17, wherein said shaft segment comprises a shaft segment uptake lumen and a shaft segment return lumen, further wherein said shaft segment uptake and return lumens are coupled to the distal end segment uptake and return lumens, respectively.
19. The catheter of claim 17, wherein said distal end segment return lumen comprises a return hole, further wherein said only one side hole is located proximally with respect to the return hole.
20. The catheter of claim 17, wherein said one side hole is directed away from a lateral wall of a vessel when the catheter is in the vessel.
21. The catheter of claim 20, wherein said one side hole is medially oriented with respect to the lateral wall of the vessel.
22. The catheter of claim 17, wherein the catheter is comprised of a flexible plastic material.
23. A catheter comprising:
- an uptake lumen including an uptake lumen shaft segment and an uptake lumen distal segment with an uptake lumen distal end;
- a return lumen including a return lumen shaft segment and a return lumen distal segment with a return lumen distal end;
- wherein the uptake lumen shaft segment is substantially parallel to the return lumen shaft segment, further wherein at least a portion of the return lumen distal segment is helically coiled around the uptake lumen distal end.
24. The catheter of claim 23, wherein said uptake lumen distal end segment comprises an uptake hole and said return lumen distal end segment comprises a return hole, further wherein said return hole is located distally with respect to the uptake hole.
25. The catheter of claim 23, wherein the return lumen end segment comprises a portion parallel to the uptake lumen end segment and disposed more distally than the uptake lumen distal end.
26. The catheter of claim 23, wherein said uptake lumen distal segment includes an uptake lumen end hole at the uptake lumen distal end, further wherein said portion of the return lumen distal segment helically coils 360 degrees about the uptake lumen end hole.
27. The catheter of claim 26, wherein said portion of the return lumen distal segment shields the uptake lumen end hole from a blood vessel or atrium wall when said catheter is disposed in a blood vessel or atrium.
28. The catheter of claim 23, wherein the catheter is comprised of a flexible plastic material.
29. A hemodialysis catheter comprising:
- a shaft segment, said shaft segment including a proximal end of the catheter and a shaft segment central axis, wherein said shaft segment comprises a shaft segment uptake lumen and a shaft segment return lumen;
- a distal end segment coupled to the shaft segment, said distal end segment including a distal end of the catheter, wherein said distal end segment comprises a distal end segment uptake lumen and a distal end segment return lumen, further wherein said distal end segment uptake and return lumens are coupled to said shaft segment uptake and return lumens and comprise a distal end segment uptake lumen central axis and distal end segment return lumen central axis, respectively;
- wherein said distal end segment uptake lumen central axis forms a non-zero angle with the shaft segment central axis when said catheter is in its unstressed configuration whereby said uptake lumen can be directed away from an adjacent wall when the catheter is inserted into a patient.
30. The catheter of claim 29, wherein the non-zero angle is in the range of 5 to 60 degrees.
31. The catheter of claim 29, wherein the non-zero angle is in the range of 5 to 45 degrees.
32. The catheter of claim 29, wherein the non-zero angle is in the range of 5 to 30 degrees.
33. The catheter of claim 29, wherein the distal end segment uptake lumen central axis and distal end segment return lumen central axis are parallel to each other.
34. The catheter of claim 29, wherein the distal end segment return lumen central axis is parallel to the shaft segment central axis.
35. The catheter of claim 29, wherein the distal end segment return lumen central axis forms a second non-zero angle with the shaft segment central axis.
36. The catheter of claim 29, wherein said distal end segment uptake lumen comprises at least one uptake hole and said distal end segment return lumen comprises at least one return hole.
37. The catheter of claim 36, wherein said uptake hole is located proximally with respect to the return hole.
38. The catheter of claim 36, wherein said uptake hole is directed away from a lateral wall of a vessel when the catheter is in the vessel.
39. The catheter of claim 36, wherein said shaft segment comprises a lateral side wall, further wherein said uptake hole is directed away from the lateral side wall such that a separation is maintained between a lateral wall of a vessel and said uptake hole when the catheter is in the vessel and the lateral side wall abuts the lateral wall of the vessel.
40. The catheter of claim 36, wherein said distal end segment return lumen comprises a return lumen end segment, further wherein said return lumen end segment maintains a separation between a medial wall of a vessel and said uptake hole when the catheter is in the vessel.
41. The catheter of claim 36, wherein said distal end segment return lumen comprises a return lumen end segment, further wherein said return lumen end segment shields the uptake hole from a medial wall of a vessel when the catheter is in the vessel.
42. The catheter of claim 38, wherein said uptake hole is medially oriented with respect to the lateral wall of the vessel.
43. The catheter of claim 29, wherein the catheter is comprised of a flexible plastic material.
44. A hemodialysis catheter comprising:
- a shaft segment, said shaft segment including a proximal end of the catheter and a shaft segment central axis, wherein said shaft segment comprises a shaft segment uptake lumen and a shaft segment return lumen;
- a distal end segment coupled to the shaft segment, said distal end segment including a distal end of the catheter, wherein said distal end segment comprises a distal end segment uptake lumen and a distal end segment return lumen, further wherein said distal end segment uptake and return lumens are coupled to said shaft segment uptake and return lumens and comprise a distal end segment uptake lumen central axis and distal end segment return lumen central axis, respectively;
- wherein said distal end segment uptake lumen central axis forms a non-zero angle with the shaft segment central axis when said catheter is in its unstressed configuration, wherein the non-zero angle is in the range of 5 to 60 degrees.
45. The catheter of claim 44, wherein the distal end segment uptake lumen central axis is angled with respect to the shaft segment central axis so that said uptake lumen can be directed away from an adjacent wall when the catheter is inserted into a patient.
46. The catheter of claim 44, wherein the non-zero angle is in the range of 5 to 45 degrees.
47. The catheter of claim 44, wherein the non-zero angle is in the range of 5 to 30 degrees.
48. The catheter of claim 44, wherein the distal end segment uptake lumen central axis and distal end segment return lumen central axis are parallel to each other.
49. The catheter of claim 44, wherein the distal end segment return lumen central axis is parallel to the shaft segment central axis.
50. The catheter of claim 44, wherein the distal end segment return lumen central axis forms a second non-zero angle with the shaft segment central axis.
51. The catheter of claim 44, wherein said distal end segment uptake lumen comprises at least one uptake hole and said distal end segment return lumen comprises at least one return hole.
52. The catheter of claim 51, wherein said uptake hole is located proximally with respect to the return hole.
53. The catheter of claim 51, wherein said uptake hole is directed away from a lateral wall of a vessel when the catheter is in the vessel.
54. The catheter of claim 51, wherein said shaft segment comprises a lateral side wall, further wherein said uptake hole is directed away from the lateral side wall such that a separation is maintained between a lateral wall of a vessel and said uptake hole when the catheter is in the vessel and the lateral side wall abuts the lateral wall of the vessel.
55. The catheter of claim 51, wherein said distal end segment return lumen comprises a return lumen end segment further wherein said return lumen end segment maintains a separation between a medial wall of a vessel and said uptake hole when the catheter is in the vessel.
56. The catheter of claim 51, wherein said distal end segment return lumen comprises a return lumen end segment further wherein said return lumen end segment shields the uptake hole from a medial wall of a vessel when the catheter is in the vessel.
57. The catheter of claim 53, wherein said uptake hole is medially oriented with respect to the lateral wall of the vessel.
58. The catheter of claim 44, wherein the catheter is comprised of a flexible plastic material.
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Type: Grant
Filed: Nov 19, 2004
Date of Patent: Dec 26, 2006
Assignee: Spire Biomedical, Inc. (Bedford, MA)
Inventor: William G. Kuhle (Camas, WA)
Primary Examiner: Patricia Bianco
Attorney: Nutter, McClennen & Fish LLP
Application Number: 10/994,218
International Classification: A61M 37/00 (20060101); A61M 3/00 (20060101); A61M 25/00 (20060101); A61F 7/00 (20060101);