Multiple lumen catheter for hemodialysis

• US 5,405,320 A
• Filed: 04/08/1993
• Issued: 04/11/1995
• Est. Priority Date: 01/08/1990
• Status: Expired due to Term

• Current Assignee: Curators of the University of Missouri (University of Missouri)
• Original Assignee: Curators of the University of Missouri (University of Missouri)
• Inventors: Nichols, W. Kirt, Van Stone, John C., Twardowski, Zbylut J.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/045,016
• Time in Patent Office: 733 Days
• Field of Search: 604/43, 604/275, 604/264, 604/280, 604/281
• US Class Current: 604/43
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 1/3658 Indicating the amount of purified blood recirculating in the fistula or shunt
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 5/1582 Double lumen needles

Abstract

A catheter for hemodialysis comprises a flexible catheter tube defining a plurality of separate lumens. The catheter defines an arc angle of generally U-shape in its natural, unstressed configuration. Thus, the catheter may be implanted with a distal catheter portion residing in a vein of the patient, the distal catheter portion being of substantially the shape of the vein in its natural, unstressed condition. Also, a proximal catheter portion resides in a surgically created tunnel extending from the vein and through the skin of the patient, this section of the catheter also being typically in its natural, unstressed condition. Thus blood may be removed from the vein through one lumen of the catheter, and blood may be returned to the vein through another lumen of the catheter, while the catheter is subject to long term indwelling in the body. Improved results are achieved because of the lack of mechanical stress in the shape of the catheter, which stress causes the catheter to press unduly against adjacent tissues.

Claims

1. A catheter for access to the venous system of a patient, said catheter comprising a flexible catheter tube having at least a pair of separate lumens for respectively withdrawing blood from said vein and returning blood thereto, said catheter defining relatively straight end portions, plus a central portion which defines, in its natural, unstressed configuration, a U-shaped section which is substantially coplanar with a major portion of the catheter, plus a second, curved arc section connected to said U-shaped section, which second section bends in an arc which extends in the dimension perpendicular to said U-shaped section, whereby said catheter may be implanted with a distal portion thereof occupying one or more of the jugular, subclavian, brachiocephalic, or vena cava veins of a patient, said distal portion being of substantially the shape of said vein or veins, and a proximal portion of said catheter is adapted to occupy a surgically-created tunnel extending from said vein or veins through the skin of the patient, while said catheter occupies substantially its natural, unstressed shape.

2. The catheter of claim 1 in which said second arc section defines an arc angle of essentially 50-90 degrees.

3. The catheter of claim 1 which carries a spaced pair of tissue securance cuffs along its proximal portion for implantation in said surgically-created tunnel.

4. The catheter of claim 1 in which the pair of separate catheter lumens terminate at distal ends in, respectively, first and second ports, said second port being positioned proximally of said first port to permit simultaneous withdrawal of blood from, and infusion of blood to said vein while minimizing recirculation of blood through the catheter.

5. The catheter of claim 1 in which a third curved section of said catheter is defined, in its natural, unstressed configuration, said third curved section being positioned between said second curved section and the distal catheter end.

6. The catheter of claim 1 in which said catheter distal portion is of a length sufficient to permit the positioning of the catheter distal end in the right atrium of the patient'"'"'s heart while the catheter enters the patient'"'"'s venous system through the left jugular vein.

7. The catheter of claim 1 in which said catheter distal portion is of a length sufficient to permit the positioning of the catheter distal end in the right atrium of the patient'"'"'s heart while the catheter enters the patient'"'"'s venous system through a jugular vein.

8. The catheter of claim 1 in which said catheter distal portion is of a length sufficient to permit the positioning of the catheter distal end in the right atrium of the patient'"'"'s heart while the catheter enters the patient'"'"'s venous system through a subclavian vein.

9. The catheter of claim 1 in which a distal portion of said arc section defining said U-shape of the catheter also defines said second arc section projecting in the dimension perpendicular to the arc section of said U-shape.

10. The catheter of claim 1 in which in said natural, unstressed configuration, said U-shaped section defines a central arc angle between a pair of relatively straight terminal catheter sections, the terminal catheter section which comprises a distal portion of said catheter bending in the dimension perpendicular to said U-shaped arc angle of the catheter.

11. The catheter of claim 1, adapted to be implanted in a patient and entering the left jugular vein, in which said distal portion in its natural, unstressed condition occupies and is substantially the shape of the left brachiocephalic vein and the vena cava, said U-shaped section being positioned both inside and outside of said venous system and adapted to extend through a wall of the left jugular vein, said second, curved arc section being connected to said U-shaped section and bending medially in an arc of 30°

-90°

in the coronal plane and 5°

-30°

anteriorly in the sagittal plane with respect to the patient, said distal portion being adapted to extend through the left brachiocephalic vein about 20-100 mm. from the second arc section to the brachiocephalic apex.

12. The catheter of claim 11 in which said catheter distal portion defines a third, curved section in its natural, unstressed configuration, said third curved section being adapted to be positioned adjacent the vein brachiocephalic apex and comprising an arc of 20°

-90°

posteriorly and about 10°

-70°

downwardly to project a catheter section 10-50 mm. in length a distance sufficient to position a portion of said catheter into the superior vena cava of the patient and to position the catheter distal end into the right atrium of the patient'"'"'s heart.

13. The catheter of claim 11 in which a portion thereof is adapted to occupy a surgical tunnel extending between the venous system and the skin of the patient, said portion carrying a pair of spaced, tissue invasive securance cuffs.

14. The catheter of claim 1, adapted to be implanted in a patient and to enter the venous system of the patient at the right jugular vein, with said U-shaped section being positioned both inside and outside of said venous system and extending through the wall of the right jugular vein, in which said distal portion of the catheter, in its natural, unstressed condition, occupies and is substantially the shape of said right brachiocephalic vein and the vena cava, said second curved arc section is adapted to be positioned in the right brachiocephalic vein.

15. The catheter of claim 14 which comprises a second bent section which extends laterally and anteriorly about 5-30 mm., and is adapted to cross anteriorly of the right clavicle, said catheter defining a proximal portion from said second bent portion extending about 20-80 mm. anteriorly at an angle of 5°

-50°

in the sagittal plane and carrying a pair of spaced, tissue invasive securance cuffs, said catheter defining a distal tip which is adapted to reside in the right atrium of the patient'"'"'s heart.

16. The catheter of claim 1, adapted to be implanted in a patient and entering the patient'"'"'s venous system at the left subclavian vein, with said U-shaped section being positioned inside and outside of said venous system and extending through the wall of the left subclavian vein, in which said distal catheter portion in its natural, unstressed condition occupies and is substantially the shape of said left brachiocephalic vein and the vena cava when so implanted, said second curved arc section defining an arc of about 10°

-50°

in the coronal plane and 5°

-30°

anteriorly in the sagittal plane relative to the patient, to direct said catheter, when implanted, distally through the left brachiocephalic vein, said catheter extending from said second arc section a distance of 20-100 mm. to a third curved section which comprises an arc extending about 20°

-90°

posteriorly in the sagittal plane and 10°

-70°

downwardly, and adapted to direct a portion of the catheter into the superior vena cava, said catheter extending about 20-120 mm. distally from said third curved section to a distal tip.

17. The catheter of claim 16 in which a portion thereof is adapted to occupy a surgical tunnel extending between the venous system and the skin of the patient, said portion carrying a pair of spaced, tissue invasive securance cuffs.

18. The catheter of claim 1, adapted to be implanted in a patient whereby the catheter enters the patient'"'"'s venous system at the right subclavian vein, said U-shaped section being adapted to be positioned inside and outside of said venous system and extending through the wall of the right subclavian vein, in which the distal catheter portion, in its natural, unstressed condition, occupies and is of substantially the shape of said right brachiocephalic vein and the vena cava.

19. The catheter of claim 18 which comprises an intramural segment extending from the entry point to the right subclavian vein through a surgical tunnel and through the skin, said intramural segment extending downwardly and anteriorly at an angle of about 5°

-30°

relative to a substantially straight distal portion of said catheter occupying the vena cava of the patient, said intramural portion carrying a pair of spaced, tissue invasive securance cuffs.

20. The catheter of claim 1, said catheter defining a tube portion positioned proximally of said U-shaped section for residing in a surgical tunnel under the skin, said proximal portion carrying a pair of spaced, tissue invasive securance cuffs.