Dialysis catheter having rigid and collapsible lumens and related method

• US 5,807,311 A
• Filed: 11/29/1996
• Issued: 09/15/1998
• Est. Priority Date: 11/29/1996
• Status: Expired due to Term

• Current Assignee: Aubrey M. Palestrant
• Original Assignee: Aubrey M. Palestrant
• Inventors: Palestrant, Aubrey M.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/758,382
• Time in Patent Office: 655 Days
• Field of Search: 604/27, 604/35, 604/43, 604/264, 604/280, 604/29, 604/28
• US Class Current: 604/28
• CPC Class Codes: A61M 2025/0025 having a collapsible lumen
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067

Abstract

A multiple-lumen catheter includes a first generally-cylindrical flexible lumen extending between a first distal end and a second proximal end; the first lumen is sufficiently rigid to maintain its generally-cylindrical shape when negative pressure is applied thereto for aspirating fluid from the blood vessel. A second flexible lumen also extends between a first distal end and a second proximal end alongside the first lumen. The first distal end of the second lumen is sufficiently pliable to collapse and flatten in the absence of any positive fluid pressure applied to the second lumen; upon the application of a positive fluid pressure to the second lumen, the collapsible first, distal end of the second lumen expands and assumes a generally-cylindrical shape for introducing fluid into the blood vessel. The first collapsible end of the second lumen can extend beyond the-first non-collapsible end of the first lumen for introducing fluid into the blood vessel through the second lumen at a point spaced apart from the first end of the first lumen. In hemodialysis applications, the first lumen is used to aspirate blood, and the second lumen is used to return cleansed blood.

Claims

1. A method of exchanging fluids with a blood vessel of a patient, said method comprising the steps of:

a. providing a first flexible tube surrounding a first lumen, the first flexible tube having a generally-cylindrical shape and having opposing first and second ends, while ensuring that the first tube is sufficiently rigid to maintain its generally-cylindrical shape when negative pressure is applied to the second end of the first lumen when aspirating fluid from the blood vessel;

b. providing a second flexible tube surrounding a second lumen, the second flexible having opposing first and second ends, and extending generally parallel to the first flexible tube;

c. forming the first end of the second tube to be sufficiently pliable to collapse and flatten in the absence of any positive fluid pressure applied to the second end of the second lumen, and sufficiently pliable to expand and assume a generally-cylindrical shape upon the application of a positive fluid pressure to the second end of said second lumen when introducing fluid into the blood vessel;

d. forming the second end of the second tube to be sufficiently rigid and non-collapsible to maintain a generally-cylindrical shape in the absence of any positive fluid pressure applied to the second end of said second lumen;

e. inserting the first ends of the first and second tubes through the patient'"'"'s skin and into a blood vessel, while leaving the second ends of the first and second tubes outside the patient'"'"'s body in order to access the first and second lumens externally;

f. forming a transition region within the second tube separating the collapsible first end of the second tube from the remaining non-collapsible portion of the second tube; and

g. inserting the first ends of the first and second tubes sufficiently far into the blood vessel to include the transition region of the second tube within the blood vessel.

2. The method recited by claim 1 including the further step of extending the first end of the second tube beyond the first end of the first tube for introducing fluid into the blood vessel through the second lumen at a point spaced apart from the first end of the first lumen.

3. The method recited by claim 2 further including the steps of coupling the second end of the first lumen to an aspiration port of a hemodialysis machine to withdraw blood containing toxins from the blood vessel, and coupling the second end of the second lumen to a cleaned blood return port of the hemodialysis machine to return cleaned blood to the blood vessel, thereby performing hemodialysis.

4. The method recited by claim 2 further including the step of securing the first tube along its length to the second tube.

5. The method recited by claim 4 wherein the step of providing the first tube includes the step of extruding generally-cylindrical walls that form the first tube, and wherein the extruding step includes the step of extruding a portion of the wall of the first tube that is secured to the second tube beyond the first end of the first lumen to the first end of the second tube to prevent the first end of the second tube from buckling during insertion into the blood vessel.

6. The method recited by claim 1 further including the step of placing an introducer sheath through the patient'"'"'s skin and into the patient'"'"'s blood vessel, and thereafter performing said inserting step by inserting the first ends of the first and second tubes through the introducer sheath.

7. The method recited by claim 6 including the step of tapering the first end of the first tube to reduce the likelihood of trauma to the blood vessel when the second lumen is advanced over the guide wire.

8. The method recited by claim 1 including the step of placing a guide wire through the patient'"'"'s skin and into the patient'"'"'s blood vessel, and thereafter performing said inserting step by inserting the first end of the second lumen over the guide wire and advancing the first ends of the first and second tubes through the patient'"'"'s skin and into the blood vessel.

9. A multiple lumen catheter for placement into a blood vessel of a patient, comprising in combination:

a. a first flexible tube having a generally-cylindrical shape and having opposing first and second ends, the first end of said first tube being adapted to extend within the blood vessel of the patient, the second end of said first tube being adapted to remain outside the patient'"'"'s body for exchanging fluids with the blood vessel of the patient, said first tube being sufficiently rigid to maintain its generally-cylindrical shape when negative pressure is applied to the second end of said first tube to aspirate fluid from the blood vessel, said first tube defining a first lumen;

b. a second flexible tube extending generally parallel to said first flexible tube, said second tube having opposing first and second ends, the first end of said second tube being adapted to extend within the blood vessel of the patient generally proximate the first end of said first tube, the second end of said second tube being adapted to remain outside the patient'"'"'s body for exchanging fluids with the blood vessel of the patient, the first end of said second tube being sufficiently pliable to collapse and flatten in the absence of any positive fluid pressure applied to the second end of said second tube, and sufficiently pliable to expand and assume a generally-cylindrical shape upon the application of a positive fluid pressure to the second end of said second tube when introducing fluid into the blood vessel, said second tube defining a second lumen;

c. the second end of said second tube being sufficiently rigid and non-collapsible to maintain a generally-cylindrical shape in the absence of any positive fluid pressure applied to the second end of said second tube; and

d. said second tube including a transition region separating the collapsible first end of said second tube from the remaining non-collapsible portion of said second tube, wherein said transition region is adapted to extend within the blood vessel of the patient.

10. The multiple lumen catheter recited by claim 9 wherein the first end of said second tube extends beyond the first end of said first tube for introducing fluid into the blood vessel through said second tube at a point spaced apart from the first end of said first tube.

11. The multiple lumen catheter recited by claim 10 wherein said first flexible tube is secured along its length to said second flexible tube.

12. The multiple lumen catheter recited by claim 11 wherein said first tube includes an extruded tubular wall secured to said second tube, and wherein a portion of said extruded tubular wall of said first tube is extruded beyond the first end of said first tube to the first end of said second tube to prevent the first end of said second tube from buckling during insertion of the multiple lumen catheter into the blood vessel.

13. The multiple lumen catheter recited by claim 12 further including an introducer sheath extending through the patient'"'"'s skin and into the patient'"'"'s blood vessel, said first and second tubes extending into and through said introducer sheath.

14. The multiple lumen catheter recited by claim 9 wherein the second end of said first tube is adapted to be coupled to an aspiration port of a hemodialysis machine to withdraw blood containing toxins from the blood vessel, and wherein the second end of said second tube is adapted to be coupled to a cleaned blood return port of the hemodialysis machine to return cleaned blood to the blood vessel, whereby the catheter may be used to perform hemodialysis.

15. The multiple lumen catheter recited by claim 9 including first and second connector tubes and further including a connector hub, the connector hub being secured to the second ends of said first and second tubes, the connector hub coupling the second end of said first tube to said first connector tube, and the connector hub coupling the second end of said second tube to said second connector tube.

16. The multiple lumen catheter recited by claim 9 wherein the first end of said second tube includes an elongated reinforcing member to prevent the first end of said second tube from buckling during insertion of the multiple lumen catheter into the blood vessel.

17. The multiple lumen catheter recited by claim 9 including a guide wire extending through said second lumen for inserting the multiple lumen catheter into the blood vessel through the skin of the patient.

18. The multiple lumen catheter recited by claim 17 wherein the first end of said first tube is tapered to reduce the likelihood of trauma to the blood vessel when said second lumen is guided over the guide wire.