Catheter tunneler adapter and methods of assembly to a catheter and use

• US 8,905,998 B2
• Filed: 10/09/2007
• Issued: 12/09/2014
• Est. Priority Date: 10/19/2006
• Status: Active Grant

• Current Assignee: Medical Components, Inc.
• Original Assignee: Medical Components, Inc.
• Inventors: Stephens, John
• Primary Examiner(s): Bosworth, Kami A
• Assistant Examiner(s): HAYMAN, IMANI N
• Application Number:
  US11/973,550
• Publication Number:
  US 20080097409A1
• Time in Patent Office: 2,618 Days
• Field of Search: 604/158, 604523-532, 604/533, 606/108
• US Class Current: 604/533
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 2017/320056 Tunnelers
• 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 2039/1077 Adapters, e.g. couplings adapting a connector to one or several other connectors
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 39/105 Multi-channel connectors or couplings, e.g. for connecting multi-lumen tubes multi-channel connectors in general F16L37/56

Abstract

A catheter tunneling adapter including a generally elongated body having a proximal end, a distal end and a through passageway. The proximal end of the adapter is connectable both to a proximal hub of a stylet and subsequently to the distal end of a tunneler. The distal end of the adapter comprises a connector for connecting a plurality of proximal catheter tubes thereto, wherein the proximal end of one tube is affixed within the passageway at the adapter'"'"'s distal end and the proximal end of the second tube is plugged by a plug extending distally from a free end of an elongate flexible arm that also extends distally of the adapter'"'"'s distal end, such that the plug is offset laterally therefrom. The flexible arm and the affixed second tube end are deflectable toward the first tube to reduce the profile of the assembly during tunneling.

Claims

1. A catheter tunneling adapter for connection to a proximal end of a catheter, comprising:

an elongated body having a distal end and a proximal end and a tubular, open passageway extending through the body from the distal end to the proximal end, the passageway having an entrance at the proximal end and an exit at the distal end, and defining a longitudinal axis,

wherein the proximal end is adapted to be removably connected to a catheter tunneler,

wherein the distal end is adapted to be connected to at least one catheter lumen, and

wherein the catheter has a first lumen and a second lumen defined in respective first and second proximal tubes of the catheter, and the adapter further includes a flexible arm that protrudes distally of the distal adapter end, offset laterally from the passageway exit at the distal end, and concludes in an elongate plug adapted to fit sealingly in a proximal end of the second proximal tube of the catheter,

whereby the passageway permits insertion of a medical device through the adapter into the at least one catheter lumen when the tunneler is not connected to the adapter.

2. The catheter tunneling adapter according to claim 1, wherein the elongated body is generally tubular.

3. The catheter tunneling adapter according to claim 1, wherein the adapter is of unitary construction.

4. The catheter tunneling adapter according to claim 1, wherein the passageway entrance is sized to securely retain a distal end of a catheter tunneler.

5. The catheter tunneling adapter according to claim 1, wherein the passageway exit is sized to receive thereinto a proximal end of the at least one lumen of the catheter.

6. The catheter tunneling device according to claim 1, wherein the plug has a D-shaped cross-section, for insertion into a correspondingly D-shaped cross-section of the second lumen of the catheter, and the passageway exit also has a D-shaped cross-section to receive thereinto the correspondingly D-shaped cross-section of the first proximal tube of the catheter.

7. The catheter tunneling device according to claim 1, wherein the flexible arm includes an elongate section adapted to be easily deflectable toward the longitudinal axis of the passageway and the first proximal tube of the catheter during tunneling.

8. The catheter tunneling adapter according to claim 7, wherein the elongate section has a flattened cross-section oriented so that the flexible arm is easily deflectable toward a longitudinal axis of the through passageway.

9. The catheter tunneling adapter according to claim 1, wherein at least the flexible arm comprises a soft material facilitating flexing of the flexible arm.

10. The catheter tunneling adapter according to claim 9, wherein the adapter comprises polyurethane.

11. The catheter tunneling adapter according to claim 1, wherein the flexible arm includes an enlargement proximally of the plug that has a maximum diameter at least as great as an outer diameter of the second proximal tube and defines a distally facing abutment shoulder for abutment with the proximal end of the second proximal tube.

12. The catheter tunneling adapter according to claim 11, wherein the enlargement is frustoconical increasing in diameter proceeding distally to the plug.

13. The catheter tunneling adapter according to claim 1, wherein the elongate section of the flexible arm extends from an outer surface of the adapter body at an angle of between 3 and 15 degrees with respect to the longitudinal axis.

14. The catheter tunneling adapter according to claim 13, wherein the elongate section extends from the outer surface of the adapter body at an angle of about 10 degrees with respect to the longitudinal axis.

15. The catheter tunneling adapter according to claim 13, wherein the enlargement and the plug extend substantially parallel to the longitudinal axis.

16. A catheter tunneling adapter for connection to a proximal end of a multiple lumen catheter, comprising:

an elongated body having a distal end and a proximal end and a longitudinal axis extending therethrough between the distal end and the proximal end,

wherein the adapter comprises a passageway extending longitudinally through the elongated body from an entrance at the proximal end to an exit at the distal end,

wherein the entrance is adapted to be removably connected to a distal end of a catheter tunneler,

wherein the exit is adapted to be connected to a first proximal tube of a catheter through which extends a first lumen of the catheter,

wherein the adapter further includes a flexible arm that protrudes distally from all other portions of the adapter and offset laterally from the passageway exit, and concludes in an elongate plug adapted to fit sealingly in a proximal end of a second proximal tube of the catheter and thus occlude a second lumen of the catheter.

17. The catheter tunneling device according to claim 16, wherein the flexible arm includes an elongate section adapted to be easily deflectable toward the longitudinal axis of the passageway and the first proximal tube of the catheter during tunneling.

18. The catheter tunneling adapter according to claim 17, wherein the elongate section has a flattened cross-section oriented so that the flexible arm is easily deflectable toward a longitudinal axis of the through passageway.

19. The catheter tunneling adapter according to claim 17, wherein at least the flexible arm comprises a soft material facilitating flexing of the flexible arm.

20. The catheter tunneling adapter according to claim 19, wherein the adapter comprises polyurethane.

21. The catheter tunneling adapter according to claim 16, wherein the flexible arm includes an enlargement proximally of the plug that has a maximum diameter at least as great as an outer diameter of the second proximal tube and defines a distally facing abutment shoulder for abutment with the proximal end of the second proximal tube.

22. The catheter tunneling adapter according to claim 21, wherein the enlargement is frustoconical increasing in diameter proceeding distally to the plug.

23. The catheter tunneling adapter according to claim 16, wherein the elongate section of the flexible arm extends from an outer surface of the adapter body at an angle of between 3 and 15 degrees with respect to the longitudinal axis.

24. The catheter tunneling adapter according to claim 23, wherein the elongate section extends from the outer surface of the adapter body at an angle of about 10 degrees with respect to the longitudinal axis.

25. The catheter tunneling adapter according to claim 24, wherein the enlargement and the plug extend substantially parallel to the longitudinal axis.

26. An assembly of the adapter of claim 16 and dual-lumen catheter affixed thereto at the distal end of the adapter.

27. The assembly of claim 26, further including a stylet extending into the entrance and through the assembly, and having a proximal hub removably affixed to the adapter proximal end.

28. A catheter tunneling adapter for connection to a proximal end of a multiple lumen catheter, comprising:

an elongated body having a distal end and a proximal end and a longitudinal axis extending therethrough between the distal end and the proximal end,

wherein the adapter comprises a passageway extending longitudinally through the elongated body from an entrance at the proximal end to an exit at the distal end,

wherein the entrance is adapted to be removably connected to a distal end of a catheter tunneler,

wherein the exit is adapted to be connected to a first proximal tube of a catheter through which extends a first lumen of the catheter,

wherein the adapter further includes a flexible arm that protrudes distally of the distal adapter end, offset laterally from the distal end, and concludes in an elongate plug adapted to fit sealingly in a proximal end of a second proximal tube of the catheter and thus occlude a second lumen of the catheter, and

wherein the flexible arm includes an enlargement proximally of the plug that has a maximum diameter at least as great as an outer diameter of the second proximal tube and defines a distally facing abutment shoulder for abutment with the proximal end of the second proximal tube, and the enlargement is frustoconical increasing in diameter proceeding distally to the plug.