Splittable multiple catheter assembly and methods of inserting the same

• US 5,947,953 A
• Filed: 08/06/1997
• Issued: 09/07/1999
• Est. Priority Date: 08/06/1997
• Status: Expired due to Term

• Current Assignee: Medical Components, Inc.
• Original Assignee: HemoCleanse, Inc., Medical Components, Inc.
• Inventors: Schweikert, Timothy M., Ash, Stephen R., Madison, Anthony J.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): Thanh, LoAn H.
• Application Number:
  US08/907,311
• Time in Patent Office: 762 Days
• Field of Search: 604/43, 604/53-54, 604/93, 604/264, 604/280, 604/283, 604/284, 604/540, 604/541, 604/508, 138/115, 138/117
• US Class Current: 604/508
• 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
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/0043 characterised by structural features

Abstract

A multiple lumen catheter assembly and methods for inserting the same are provided. The assembly includes a splittable membrane joining a first catheter and a second catheter for allowing the catheters to be at least partially longitudinally split from each other. Each catheter has at least one lumen extending longitudinally through the catheter. One method for inserting the assembly includes making an incision near the area to be catheterized, at least partially splitting the distal end regions of the catheters from each other by splitting apart the splittable membrane, and inserting the distal end regions of the catheters in a juxtaposed relation through the incision and into the area to be catheterized. In another method, the catheters are first tunnelled subcutaneously by pulling the distal end regions of the catheters in the assembly through a tunnel and outwardly from the tunnel near the area to be catheterized, leaving proximal end regions at least partially within the tunnel. An incision is made near the area to be catheterized, the distal end regions of the catheters are at least partially split from each other by splitting the splittable membrane, and the distal end regions of the catheters are inserted in a juxtaposed relation through the incision and into the area to be catheterized.

Claims

1. A multiple catheter assembly, comprising:

(a) a first catheter having a proximal tip, a distal end region terminating in a distal tip, and an outer surface defining at least a first lumen extending longitudinally therethrough between a distal and a proximal opening;

(b) a second catheter having a proximal tip, a distal end region terminating in a distal tip, and an outer surface defining at least a second lumen extending longitudinally therethrough between a distal and a proximal opening, wherein the first lumen and the second lumen are independent from each other for facilitating simultaneous flow in opposite directions; and

(c) a splittable membrane joining the outer surfaces of both the first and second catheters for allowing the first and second catheters to be at least partially longitudinally split from each other.

2. The multiple catheter assembly according to claim 1, wherein the first and second catheters have a generally semi-circular cross section, the first catheter comprises a generally flat side surface, and the second catheter comprises a generally flat side surface.

3. The multiple catheter assembly according to claim 2, wherein the membrane extends longitudinally between the generally flat side surface of the first catheter and the generally flat side surface of the splittable second catheter, and the splittable membrane has a cross-sectional length which is significantly smaller than an outer diameter of said multiple catheter assembly as measured transversely across said multiple catheter assembly.

4. The multiple catheter assembly according to claim 2, wherein the distal end regions of the first and second catheters each have a generally circular cross section, and the outer surfaces of the first and the second catheters are rounded inwardly at a point of transition along each of the first and second catheters between the generally semi-cylindrical cross sections of the catheters and the generally circular cross sections of the distal end regions.

5. The multiple catheter assembly according to claim 1, wherein the first catheter has a first length as measured longitudinally between said distal and proximal tips of said first catheter and the second catheter has a second length as measured longitudinally between said distal and proximal tips of said second catheter, wherein said second length is longer than said first length.

6. The multiple catheter assembly according to claim 1, wherein the proximal tips of the first and second catheters are substantially aligned with each other and the distal tips are longitudinally spaced from each other.

7. The multiple catheter assembly according to claim 6, wherein the distal tips are longtudinally spaced a distance sufficient to prevent recirculation of fluid passing through the distal opening of the first catheter in a first flow direction and fluid passing through the distal opening of the second catheter in a second flow direction opposite to the first direction.

8. The multiple catheter assembly according to claim 1, wherein the first and second catheters are identical in cross section.

9. The multiple catheter assembly according to claim 1, wherein the assembly further comprises a third catheter having an outer surface defining at least a first longitudinally extending lumen and a second splittable membrane joining the outer surface of the first catheter and the outer surface of the third catheter.

10. The multiple catheter assembly according to claim 9, wherein the assembly further comprises a third splittable membrane extending longtudinally between the outer surface of the second catheter and the outer surface of the third catheter.

11. The multiple catheter assembly according to claim 1, further comprising a first proximally extending extension tube in fluid communication with the proximal opening of the first catheter and a second proximally extending extension tube in fluid communication with the proximal opening of the second catheter.

12. The multiple catheter assembly according to claim 11, wherein the first and second catheters are attached to the respective first and second extension tubes by a hub.

13. The multiple catheter assembly according to claim 1, wherein the first catheter comprises an internal longitudinally extending septum dividing said first lumen.

14. The multiple catheter assembly according to claim 1, wherein a plurality of apertures is arranged circumferentially around each of the distal end region of the first catheter and the distal end region of the second catheter.

15. A method for inserting a multiple catheter assembly into an area of a body to be catheterized, the multiple catheter assembly comprising (i) a first catheter having a proximal end region terminating in a proximal tip, a distal end region terminating in a distal tip, and an outer surface defining at least a first longitudinally extending lumen, (ii) a second catheter having a proximal end region terminating in a proximal tip, a distal end region terminating in a distal tip, and an outer surface defining at least a second longitudinally extending lumen, wherein the first lumen and the second lumen are independent from each other for facilitating simultaneous flow in opposite directions, and (iii) a splittable membrane joining the outer surfaces of both the first and second catheters, the method comprising the steps of:

(a) making an incision near the area to be catheterized;

(b) at least partially splitting the distal end regions of the first catheter and the second catheter from each other by splitting the splittable membrane; and

(c) inserting the distal end regions of the first and second catheters in juxtaposed relation through the incision and into the area to be catheterized.

16. The method according to claim 15, further comprising inserting a tearable sheath into the area to be catheterized prior to step (c), and wherein step (c) further comprises inserting the distal end regions through the sheath and into the area to be catheterized.

17. The method according to claim 16, further comprising removing the sheath after the distal end regions of the first and second catheters are in the area to be catheterized.

18. The method according to claim 15, further comprising closing the incision after the distal end regions are inserted in the area to be catheterized.

19. The method according to claim 15, further comprising securing the proximal end regions of the first and second catheters to the body.

20. A method for inserting a multiple catheter assembly into an area of a body to be catheterized, the multiple catheter assembly comprising (i) a first catheter having a proximal end region terminating in a proximal tip, a distal end region terminating in a distal tip, and an outer surface defining at least a first longitudinally extending lumen, (ii) a second catheter having a proximal end region terminating in a proximal tip, a distal end region terminating in a distal tip, and an outer surface defining at least a second longitudinally extending lumen, wherein the first lumen and the second lumen are independent from each other for facilitating flow in opposite directions, and (iii) a splittable membrane joining the outer surfaces of both the first and second catheters, the method comprising the steps of:

(a) subcutaneously moving the first and second catheters through a tunnel formed in the body by pulling the distal end regions through the tunnel and outwardly therefrom near the area to be catheterized, leaving the proximal end regions at least partially within the tunnel;

(b) making an incision near the area to be catheterized;

(c) at least partially splitting the distal end regions of the first and the second catheters from each other by splitting the splittable membrane; and

(d) inserting the distal end regions of the first and second catheters in juxtaposed relation through the incision and into the area to be catheterized.

21. The method according to claim 20, further comprising inserting a tearable sheath into the area to be catheterized prior to step (d), and wherein step (d) further comprises inserting the distal end regions through the sheath and into the area to be catheterized.

22. The method according to claim 21, further comprising removing the sheath after the distal end regions of the first and second catheters are in the area to be catheterized.

23. The method according to claim 20, further comprising closing the incision after the distal end regions are inserted in the area to be catheterized.

24. The method according to claim 20, further comprising securing the proximal end regions of the first and second catheters within the tunnel.