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

• US 20080097409A1
• Filed: 10/09/2007
• Published: 04/24/2008
• Est. Priority Date: 10/19/2006
• Status: Active Grant

• Current Assignee: Medical Components, Inc.
• Original Assignee: Medical Components, Inc.
• Inventors: Stephens, John
• Granted Patent: US 8,905,998 B2
• Time in Patent Office: Days
• 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 (10) including a generally elongated body (12) having a proximal end (14), a distal end (16) and a through passageway (18) extending therethrough between the proximal and distal end. The proximal end (14) of the adapter (10) is connectable both to a proximal hub of a stylet (70) and subsequently to the distal end (84,94) of a tunneler (80,90). The distal end (16) of the adapter (10) comprises a connector for connecting a plurality of proximal catheter tubes (52,54) thereto, wherein the proximal end of one tube (52) is affixed within the passageway at the adapter'"'"'s distal end (16) and the proximal end of the second tube (54) is plugged by a plug (40) extending distally from a free end of an elongate flexible arm (30) that also extends distally of the adapter'"'"'s distal end (16), such that the plug is offset laterally therefrom. The flexible arm (30) and the affixed second tube end (58) are deflectable toward the first tube (52) to reduce the profile of the assembly during tunneling. Methods of affixing an adapter to a catheter, of inserting a catheter into a patient, and of subcutaneously tunneling a catheter under a patient'"'"'s skin using the tunneling device, are also disclosed.

Claims

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

a generally 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 proximal end is adapted to be removably connected to a catheter tunneler, and

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

2. The catheter tunneling adapter according to claim 1, wherein the generally 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 adapter comprises a passageway extending generally longitudinally through the generally elongated body from an entrance at the proximal end to an exit at the distal end.

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

6. 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.

7. The catheter tunneling adapter according to claim 4, 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 distal end, and concludes in an elongate plug adapted to fit sealingly in a proximal end of the second proximal tube of the catheter.

8. The catheter tunneling device according to claim 7, 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.

9. The catheter tunneling device according to claim 7, 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.

10. The catheter tunneling adapter according to claim 9, 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.

11. The catheter tunneling adapter according to claim 7, wherein at least the flexible arm comprises a soft material facilitating flexing of the flexible arm.

12. The catheter tunneling adapter according to claim 11, wherein the adapter comprises polyurethane.

13. The catheter tunneling adapter according to claim 7, 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.

14. The catheter tunneling adapter according to claim 13, wherein the enlargement is frustoconical increasing in diameter proceeding distally to the plug.

15. The catheter tunneling adapter according to claim 7, 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.

16. The catheter tunneling adapter according to claim 15, 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.

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

18. A catheter tunneling adapter for connection to a proximal end of a single-lumen catheter, comprising:

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

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

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

wherein the exit is adapted to receive thereinto to a proximal end of the catheter.

19. An assembly of the adapter of claim 18 and a single-lumen catheter affixed thereto at the distal end of the adapter.

20. The assembly of claim 19, further including a stylet extending into the entrance and through the assembly, and having a proximal hub removably affixed to the adapter proximal end.

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

a generally 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 generally longitudinally through the generally 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.

22. The catheter tunneling device according to claim 21, 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.

23. The catheter tunneling adapter according to claim 22, 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.

24. The catheter tunneling adapter according to claim 22, wherein at least the flexible arm comprises a soft material facilitating flexing of the flexible arm.

25. The catheter tunneling adapter according to claim 24, wherein the adapter comprises polyurethane.

26. The catheter tunneling adapter according to claim 21, 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.

27. The catheter tunneling adapter according to claim 26, wherein the enlargement is frustoconical increasing in diameter proceeding distally to the plug.

28. The catheter tunneling adapter according to claim 21, 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.

29. The catheter tunneling adapter according to claim 28, 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.

30. The catheter tunneling adapter according to claim 29, wherein the enlargement and the plug extend generally parallel to the longitudinal axis.

31. An assembly of the adapter of claim 21 and dual-lumen catheter affixed thereto at the distal end of the adapter.

32. The assembly of claim 31, further including a stylet extending into the entrance and through the assembly, and having a proximal hub removably affixed to the adapter proximal end.

33. A method of assembling a tunneling adapter to a proximal end of a dual-lumen catheter, comprising the steps of:

providing an adapter, the adapter having a proximal end and a distal end and a passageway extending therethrough from an entrance at the proximal end and an exit at the distal end, the adapter entrance adapted to receive removably thereinto a distal end of a tunneler, and the adapter further including a flexible arm extending distally beyond the distal end and concluding in a distally extending plug spaced laterally of the longitudinal axis of the adapter;

providing a dual-lumen catheter and splitting a proximal portion thereof into first and second proximal tubes;

affixing a proximal end of the first proximal tube within the passageway exit of the adapter, and

affixing a proximal end of the second proximal tube onto and around the plug, thereby occluding the second lumen.

34. The method of assembling a tunneling adapter to a catheter according to claim 33, further including the step of shortening the length of the second proximal tube such that the affixing of the first and second proximal tubes to the adapter permits the first and second proximal tubes to remain adjacent to each other.

35. A method of inserting a catheter having a single lumen into a patient, comprising the steps of:

providing an adapter assembled to a single lumen catheter, the adapter having a proximal end and a distal end and a passageway extending therethrough from an entrance at the proximal end and an exit at the distal end, the adapter entrance adapted to receive removably thereinto a distal end of a tunneler, and the single lumen catheter having a proximal end and a distal end, the proximal end of the catheter being affixed within a passageway exit of the adapter;

inserting a distal end of the catheter lumen into a blood vessel in the patient;

connecting a distal end of a tunneler to the passageway entrance of the adapter and forming a subcutaneous tunnel with the tunneling device and drawing the proximal end of the lumen through the tunnel;

severing the proximal end of the catheter adjacent the adapter; and

connecting the thus-newly defined proximal end of the lumen to a fitting.

36. The method according to claim 35, wherein the forming of the tunnel is performed prior to connecting the tunneler to the adapter and drawing the proximal end of the lumen through the tunnel.

37. The method according to claim 35, wherein the distal end of the tunneler is removably secured to the proximal end of the adapter, and the steps of tunneling and drawing the proximal end of the catheter are performed simultaneously.

38. The method according to claim 37, further including an additional step of removably affixing a stylet to the adapter at the proximal end of the adapter such that the stylet extends through the adapter passageway and through the lumen of the catheter, and the step of inserting the distal portion of the catheter in the blood vessel includes the step of accessing the blood vessel with a dilator, inserting a guide wire through the dilator and extending it to the desired location in the blood vessel, removing the dilator, inserting the proximal end of the guide wire into the stylet from the distal end of the catheter, and inserting the distal end of the catheter into the blood vessel along the guide wire.

39. A method of inserting a dual-lumen catheter into a blood vessel of a patient, comprising the steps of:

providing an adapter assembled to a dual-lumen catheter, the adapter having a proximal end and a distal end and a passageway extending therethrough from an entrance at the proximal end and an exit at the distal end, the adapter entrance adapted to receive removably thereinto a distal end of a tunneler, and the adapter further including a flexible arm extending distally beyond the distal end and concluding in a distally extending plug spaced laterally of the longitudinal axis of the adapter, and the dual-lumen catheter having a proximal end and a distal end, the proximal end of the catheter defined by two proximal tubes through which extend a first and second lumen of the catheter, respectively, the proximal end of the first proximal tube being affixed within the passageway exit of the adapter, and the proximal end of the second proximal tube being inserted around the plug;

inserting a distal end of the catheter into a blood vessel in the patient;

connecting a distal end of a tunneler to the passageway entrance of the adapter and forming a subcutaneous tunnel with the tunneling device and drawing the proximal ends of the catheter through the tunnel;

severing the proximal ends of the catheter adjacent the adapter; and

connecting the thus-newly defined proximal ends of the lumen to respective fittings.

40. The method according to claim 39, wherein the forming of the tunnel is performed prior to connecting the tunneler to the adapter and drawing the proximal end of the lumen through the tunnel.

41. The method according to claim 39, wherein the distal end of the tunneler is removably secured to the proximal end of the adapter, and the steps of tunneling and drawing the proximal end of the catheter are performed simultaneously.

42. The method according to claim 41, further including an additional step of removably affixing a stylet to the adapter at the proximal end of the adapter such that the stylet extends through the adapter passageway and through the lumen of the catheter, and the step of inserting the distal portion of the catheter in the blood vessel includes the step of accessing the blood vessel with a dilator, inserting a guide wire through the dilator and extending it to the desired location in the blood vessel, removing the dilator, inserting the proximal end of the guide wire into the stylet from the distal end of the catheter, and inserting the distal end of the catheter into the blood vessel along the guide wire.