Multilumen catheter assembly and methods for making and inserting the same

• US 6,881,211 B2
• Filed: 10/08/2003
• Issued: 04/19/2005
• Est. Priority Date: 06/01/2000
• Status: Expired due to Term

• Current Assignee: Medical Components, Inc.
• Original Assignee: Medical Components, Inc., Twincath LLC
• Inventors: Schweikert, Timothy M., Schon, Donald, Madison, Anthony
• Primary Examiner(s): ROBINSON, DANIEL LEON
• Application Number:
  US10/681,394
• Publication Number:
  US 20040075198A1
• Time in Patent Office: 559 Days
• Field of Search: 604/544, 604/43, 604/28, 604/34, 604/35, 604/284, 604/96.01, 604/536
• US Class Current: 604/544
• 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 2025/0081 Soft tip
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• 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 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip

Abstract

A multilumen catheter assembly and methods for making and inserting the same are provided. The catheter assembly includes a unitary catheter and at least two distal end tubes which extend distally from the unitary catheter. The at least two lumens in the unitary catheter are in fluid communication with passageways through the distal end tubes. The catheter assembly may be made by extruding a unitary catheter tube having internal longitudinally extending lumens, then splitting the tube on its distal end portion to form distal end tubes. The tubes are then ground and polished to form a smooth surface on the exterior of the tubes. The catheter assembly may also be made by forming an outer layer on at least two longitudinally extending catheters while leaving two distally extending portions of the tubes outside the outer layer to form the distal end tubes. The multilumen catheter assembly may be inserted in a patient for acute and chronic catheterization and subcutaneously tunneled and inserted using a single insertion procedure while leaving the distal end tubes within the vessel capable of free movement and sealing the insertion site into an area to be catheterized.

Claims

1. A method of making a multilumen catheter, comprising:

forming a unitary catheter tube to have a distal portion and a distal end portion terminating in a distal end, a proximal portion terminating in a proximal end, and a first lumen and a second lumen, each of the first lumen and the second lumen extending longitudinally through the unitary catheter tube; and

splitting the unitary catheter tube longitudinally along the distal end portion of the unitary catheter tube to form a first distal end tube and a second distal end tube.

2. The method according to claim 1, further comprising grinding and polishing the first and second distal end tubes to provide a generally smooth exterior surface to each of the two distal end tubes.

3. The method according to claim 2, further comprising grinding and polishing the first and second distal end tubes on a mandrel to shape the first and second distal end tubes to have a generally circular transverse cross sectional configuration.

4. The method according to claim 1, further comprising forming the unitary catheter tube by a heat molding process.

5. The method according to claim 4, wherein the heat molding process is extrusion.

6. The method according to claim 1, further comprising forming the unitary catheter tube such that the unitary catheter tube has a cross sectional configuration which is generally oval.

7. The method according to claim 1, further comprising forming the unitary catheter tube such that the first and second lumens of the unitary catheter tube are substantially identical in transverse cross section.

8. The method according to claim 7, wherein the first and second lumens have a generally circular transverse cross section.

9. The method according to claim 1, further comprising forming a plurality of holes through an exterior surface of the first distal end tube and through an exterior surfaced of the second distal end tube.

10. The method according to claim 1, wherein the first distal end tube has a length which is less than a length of the second distal end tube, the lengths being measured in a longitudinal direction.

11. The method according to claim 1, further comprising providing a first extension tube in fluid communication with a proximal end of the first lumen and a second extension tube in fluid communication with a proximal end of the second lumen.

12. The method according to claim 11, further comprising providing a hub having at least a first passageway and a second passageway extending therethrough which connects the proximal end of the unitary catheter tube to the first and second extension tubes such that the first passageway is in fluid communication with the first lumen and the first extension tube and the second passageway is in fluid communication with the second lumen and the second extension tube.

13. The method according to claim 12, wherein the hub is formed by heat molding and the method further comprises inserting a first rod in the first extension tube and in the first lumen such that the first lumen is spaced from the first extension tube, inserting a second rod in the second extension tube and in the second lumen such that the second lumen is spaced from the second extension tube, molding the hub around the rods such that the hub encloses the proximal end of the unitary catheter and connects the proximal end of the unitary catheter to the first and second extension tubes, and removing the first rod and the second rod after forming the hub.

14. The method according to claim 13, wherein the hub is molded to have proximally extending projections formed around distal ends of the first and second extension tubes to divert the first and second extension tubes away from each other.

15. A method of making a multilumen catheter assembly, comprising:

arranging a first catheter having a distal end, a distal end portion and at least one first lumen extending longitudinally therethrough and a second catheter having a distal end, a distal end portion and at least one second lumen extending longitudinally therethrough such that the first catheter and the second catheter are substantially longitudinally parallel; and

forming an outer layer around at least a portion of an exterior surface of the first catheter proximal to the distal end portion of the first catheter and around at least a portion of an exterior surface of the second catheter proximal to the distal end portion of the second catheter such that the first catheter and the second catheter are fixed within the outer layer, the first lumen and the second lumen are generally parallel within the outer layer and the distal end portions of the first and second catheters extend outwardly and distally from the portions of the exterior surfaces of the first and second catheters which are within the outer layer and the distal end portions are capable of independent movement.

16. The method according to claim 15, wherein the outer layer is heat molded around at least a portion of the exterior surface of the first catheter and around at least a portion of the exterior surface of the second catheter.

17. The method according to claim 16, wherein the first and second catheter are in juxtaposed relation within the outer layer.

18. The method according to claim 15, wherein a proximal end portion of the first catheter and a proximal end portion of the second catheter extend proximally from a proximal end of the outer layer and a hub is provided around the proximal end of the outer layer and around a section of the proximal end portions of the first and second catheter adjacent the outer layer.

19. A method of making a multilumen catheter assembly, comprising:

forming a unitary catheter tube to have a distal portion and a distal end portion terminating in a distal end, a proximal portion terminating in a proximal end, and a first lumen and a second lumen, each of the first lumen and the second lumen extending longitudinally through the unitary catheter tube;

forming a first distal end tube having a first passageway extending longitudinally therethrough and a second distal end tube having a second passageway extending longitudinally therethrough; and

attaching the first and second distal end tubes to the distal end of the unitary catheter tube such that the first passageway in the first distal end tube is in communication with the first lumen of the unitary catheter tube and the second passageway in the second distal end tube is in communication with the second lumen in the unitary catheter tube.