Catheter having two coaxial lumens

• US 5,053,004 A
• Filed: 08/24/1990
• Issued: 10/01/1991
• Est. Priority Date: 08/24/1990
• Status: Expired due to Term

• Current Assignee: David F. Markel
• Original Assignee: Medical Components, Inc.
• Inventors: Roberts, David E., Harkins, William R., Madison, Anthony J., Markel, David F.
• Primary Examiner(s): Grieb, William H.
• Application Number:
  US07/571,930
• Time in Patent Office: 403 Days
• Field of Search: 604/43, 604/44, 604/45, 29/428
• US Class Current: 604/43
• CPC Class Codes: A61M 1/3661 for haemodialysis
• 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 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 5/1582 Double lumen needles
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A double-lumen catheter is made of two generally coaxial tubes. The tubes are joined, at their distal ends, by a sleeve inserted between the tubes, the sleeve being bonded to both tubes. The inner and outer tubes are connected, respectively, at their proximal ends, to first and second hubs. The hubs are bonded together. The distal ends of the tubes may be formed into a tapered tip, preferably having a rounded edge. The proximal ends of the tubes can be connected to external fluid devices. The invention also includes a method of making the catheter. According to this method, inner and outer tubes are separately formed, and the proximal end of each tube is connected to a hub. Then, the inner tube is threaded into the outer tube, until the distal ends of the tubes are near each other. A sleeve is inserted between the tubes, at the distal end, and the sleeve is then bonded to both tubes. The hubs are also bonded together. Thus, the tubes are firmly joined to each other, but only at their distal and proximal ends. The outer tube has a plurality of holes, located around its circumference, at the distal end, to provide access to the outer lumen. The distal tip provides an exit port for the inner lumen. The catheter can also be provided with a dilator/stylet which is initially inserted within the inner lumen, and which is withdrawn after the catheter has been inserted into a patient.

Claims

1. A double-lumen catheter, comprising:

a) a generally cylindrical inner tube having interior and exterior surfaces,

b) a generally cylindrical outer tube having interior and exterior surfaces, the outer tube being arranged around the inner tube such that the inner and outer tubes are substantially coaxial, the inner tube defining an inner lumen having a generally circular cross-section, the inner and outer tubes defining an outer lumen having a generally annular cross-section, the tubes having a proximal end and a distal end,

c) a generally cylindrical sleeve inserted between the tubes at the distal end, the sleeve being bonded to the inner tube and to the outer tube,

d) a first hub formed around the exterior surface of the proximal end of the inner tube,

e) a second hub formed around the exterior surface of the proximal end of the outer tube, the second hub extending beyond the outer tube in the proximal direction, wherein the first and second hubs are bonded together, and

f) means for connecting the lumens to fluid conveying devices.

2. The catheter of claim 1, wherein there are a plurality of holes in the outer tube, the holes being located near the distal end of the outer tube, the holes being disposed around more than half the circumference of the outer tube.

3. The catheter of claim 1, wherein the distal ends of the tubes define a tip, the tip including an opening fluidly connected to the first lumen.

4. The catheter of claim 3, wherein the edges of the tip are rounded.

5. The catheter of claim 1, further comprising a dilator, the dilator being inserted within the inner lumen, the catheter having means for attaching the dilator to the catheter.

6. The catheter of claim 5, wherein the attaching means comprises a threaded flange located near the proximal end of the catheter, and wherein the dilator includes threaded means for engaging said flange.

7. The catheter of claim 5, wherein the dilator comprises a generally hollow, cylindrical tube.

8. The catheter of claim 7, wherein the dilator protrudes beyond the distal ends of the inner and outer tubes.

9. The catheter of claim 1, wherein the connecting means includes a side port which is fluidly connected to the outer lumen.

10. The catheter of claim 9, wherein the first hub includes a bevel at its distal end, the bevel comprising means for directing fluid into the side port, and for preventing fluid from becoming trapped in the outer lumen, proximal of the side port.

11. A double-lumen catheter comprising a pair of generally coaxial tubes, the tubes defining independent inner and outer lumens, the tubes having distal ends and proximal ends, the tubes being joined at their distal ends by a sleeve located between the tubes, the sleeve being bonded to both of the tubes, each of the tubes being bonded, respectively, at their proximal ends, to first and second hubs, the hubs being bonded to each other.

12. The catheter of claim 11, wherein one of the tubes is the outer tube and one of the tubes is the inner tube, wherein there are a plurality of holes in the outer tube, the holes being located near the distal end of the outer tube, the holes being disposed around more than half the circumference of the outer tube.

13. The catheter of claim 11, wherein the distal ends of the tubes define a tip, the tip including an opening fluidly connected to the inner lumen.

14. The catheter of claim 13, wherein the edges of the tip are rounded.

15. The catheter of claim 11, further comprising a dilator, the dilator being inserted within the inner lumen, the catheter having means for attaching the dilator to the catheter.

16. The catheter of claim 15, wherein the attaching means comprises a threaded flange located near the proximal end of the catheter, and wherein the dilator includes threaded means for engaging said flange.

17. The catheter of claim 15, wherein the dilator comprises a generally hollow, cylindrical tube.

18. The catheter of claim 17, wherein the dilator protrudes beyond the distal ends of the inner and outer tubes.

19. The catheter of claim 11, wherein the catheter includes means for connecting the lumens to fluid conveying devices.

20. The catheter of claim 19, wherein the connecting means includes a side port which is fluidly connected to the outer lumen.

21. The catheter of claim 20, wherein one of the tubes is an inner tube and one of the tubes is an outer tube, and wherein the hub which is connected to the inner tube includes a bevel at its distal end, the bevel comprising means for directing fluid into the side port, and for preventing fluid from becoming trapped in the outer lumen, proximal of the side port.

22. A method of making a double-lumen coaxial catheter, the method comprising the steps of:

a) forming an outer tube, the outer tube having a distal end and a proximal end, the outer tube having interior and exterior surfaces,

b) punching at least one hole near the distal end of the outer tube,

c) attaching a hub to the exterior surface of the outer tube, near the proximal end of the outer tube, such that the hub projects beyond the outer tube,

d) forming an inner tube, the inner tube having a distal end and a proximal end, the inner tube having interior and exterior surfaces,

e) attaching a hub to the exterior surface of the inner tube, near the proximal end of the inner tube,

f) threading the inner tube into the outer tube, such that the inner tube moves from the proximal end towards the distal end of the outer tube, until the inner tube reaches the vicinity of the distal end of the outer tube,

g) inserting a generally cylindrical sleeve between the inner and outer tubes, at their distal ends,

h) bonding the sleeve to both the inner and outer tubes, and

i) bonding the hubs of the tubes to each other.

23. The method of claim 22, wherein step (h) also includes forming the distal ends of the tubes into a tip, the tip including means for fluidly connecting the inner tube to the outside of the catheter.

24. The method of claim 22, further comprising the step of attaching fittings to the hubs for connection of the hubs to external fluid devices.

25. The method of claim 24, further comprising the step of inserting a dilator into the inner tube, such that the dilator protrudes beyond the distal end of the inner tube.

26. The method of claim 22, wherein step (h) comprises the step of applying heat to the tubes at their distal ends, so that the sleeve becomes fused to the tubes.

27. The method of claim 26, wherein the heat-applying step is preceded by the step of adhesively fastening the sleeve to the tubes.

28. A method of making a double-lumen coaxial catheter, comprising the steps of:

a) providing an inner tube having distal and proximal ends, and having at least one hole near the distal end,

b) connecting a first hub to the proximal end of the inner tube,

c) providing an outer tube having distal and proximal ends, the outer tube having a diameter greater than that of the inner tube,

d) connecting a second hub to the proximal end of the outer tube,

e) threading the inner tube into the outer tube such that the distal end of the inner tube is positioned near the distal end of the outer tube,

f) bonding the inner and outer tubes together at their distal ends, and

g) bonding the first and second hubs together.

29. The method of claim 28, wherein step (f) comprises the step of inserting a sleeve between the inner and outer tubes, at their distal ends, and applying heat to the tubes at their distal ends, so that the sleeve becomes fused to the tubes.

30. The method of claim 29, wherein the heat-applying step is preceded by the step of adhesively fastening the sleeve to the tubes.

31. A method of making a double-lumen coaxial catheter, comprising the steps of:

a) providing an inner tube having distal and proximal ends, and having at least one hole near the distal end, and an outer tube having distal and proximal ends, the outer tube having a diameter greater than that of the inner tube,

b) threading the inner tube into the outer tube such that the distal end of the inner tube is positioned near the distal end of the outer tube,

c) connecting a hub to the proximal ends of the tubes, in such a manner that the hub comprising means for holding the inner tube within the outer tube, and

d) bonding the inner and outer tubes together at their distal ends.