CATHETER HAVING A CORE WIRE AND A LOW PROFILE BOND

• US 20090163891A1
• Filed: 12/19/2008
• Published: 06/25/2009
• Est. Priority Date: 12/20/2007
• Status: Active Grant

• Current Assignee: Bayer Pharma AG (Bayer AG)
• Original Assignee: Bayer Schering Pharma AG (Bayer AG)
• Inventors: Periard, John R., Brucker, Gregory G., Bednar, Scott A., Ewing, Benjamin T.
• Granted Patent: US 8,267,886 B2
• Time in Patent Office: Days
• US Class Current: 604/526
• 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 2025/0036 with more than four lumina
• 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 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon
• CPC Class Codes: A61M 25/1036 Making parts for balloon catheter systems, e.g. shafts or distal ends A61M25/1029 takes precedence
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A catheter having a shaft that has at least two spaced-apart lumens is disclosed. A retractable core wire is disposed within at least one of the lumens. The retractable core wire is manipulated by the user to impart variable stiffness to the shaft as the core wire is retracted and extended within the lumen. A catheter having substantially low profile bonds at the junctions where an inflatable balloon is attached to the catheter is also disclosed. The low profile bonds are created by recesses extending around the circumference of the distal end of the shaft, the proximal and distal ends of a stem, and the proximal end of a tip. The catheter having the low profile bond optionally has either a retractable or an embedded core wire. In examples, the catheter has at least one component formed from, co-extruded with, or coated with a lubricious material or a hydrophilic material.

Claims

1. A core wire for use with a catheter, the core wire comprising a substantially stiff member configured for retractable disposition into a lumen of the catheter;

wherein the member has proximal and distal ends and a length defined by the ends that is substantially equal to or less than a length of the lumen of the catheter; and

wherein the member has an outer diameter that is less than an inner diameter of the lumen of the catheter.

2. The core wire as in claim 1, further comprising a tab coupled to at least one of the proximal end and a proximal portion of the substantially stiff member, wherein the tab facilitates retraction and extension of the member within the lumen.

3. The core wire as in claim 1, wherein the member is at least one of substantially elongate, substantially helical, substantially tapered, and substantially coiled with a solid substantially tapered inner core.

4. The core wire as in claim 1, wherein the member is made from at least one material selected from the group consisting of stainless steel, nitinol, and plastic.

5. The core wire as in claim 1, wherein the member is at least one of formed from, co-extruded with, and coated with a lubricious material or a hydrophilic material.

6. The core wire as in claim 5, wherein the lubricious material is selected from the group consisting of nylon, Rilsan®

nylon, polytetrafluoroethylene (PTFE), PEBAX®

material, PEEK, polyimide, polyethylene of varying densities, PE, PET, PU, HDPE, and fluorinated ethylene propylene.

7. A catheter comprising:

a connector having an inflation channel and a guidewire channel;

a shaft joined at a proximal end to the connector and having an inflation lumen that is in fluid communication with the inflation channel, at least one core wire lumen, and a guidewire lumen configured for disposition of a guidewire therein and in fluid communication with the guidewire channel;

at least one retractable core wire disposed within the at least one core wire lumen, wherein the at least one retractable core wire has an outer diameter that is smaller than an inner diameter of the at least one lumen into which the core wire is disposed, and wherein the retractable core wire comprises a substantially stiff member having proximal and distal ends and a length defined by the ends that is substantially equal to or less than a length of the core wire lumen;

a stem having a stem guidewire lumen portion configured for disposition of the guidewire therein and in fluid communication with the guidewire lumen;

a tip having a tip guidewire lumen portion configured for disposition of the guidewire therein and in fluid communication with the stem guidewire lumen portion; and

an inflatable balloon positioned substantially around the exterior of the stem, having proximal and distal ends, and that is in fluid communication with the inflation lumen.

8. The catheter as in claim 7, wherein the stem further comprises at least one stem core wire lumen portion configured for disposition of the core wire therein and in fluid communication with the at least one core wire lumen of the shaft.

9. The catheter as in claim 8, wherein the tip further comprises at least one tip core wire lumen portion configured for disposition of the core wire therein and in fluid communication with the at least one stem core wire lumen portion.

10. The catheter as in claim 7, wherein the connector further comprises a core wire channel that is in fluid communication with the core wire lumen, that is capable of receiving at least a proximal portion of the retractable core wire, and that is configured for retraction and extension of the retractable core wire therethrough.

11. The catheter as in claim 7, wherein the retractable core wire further comprises a tab connected to at least one of the proximal end and a proximal portion of the substantially stiff member, wherein the tab is configured for manipulation of the retractable core wire to retract the core wire in a proximal direction and to extend the core wire in a distal direction to vary the stiffness of the catheter.

12. The catheter as in claim 7, wherein the retractable core wire is removable.

13. The catheter as in claim 7, wherein the lumens are spaced apart.

14. The catheter as in claim 7, comprising at least two retractable core wires, wherein each core wire is disposed into the core wire lumens and wherein the retractable core wires have different stiffnesses.

15. The catheter as in claim 7 wherein at least two lumens are substantially parallel to each other.

16. The catheter as in claim 13 wherein one of the lumens is positioned substantially concentric to the other lumens.

17. The catheter as in claim 7 wherein the at least one core wire lumen is concentrically positioned around the inflation lumen.

18. The catheter as in claim 7 wherein the member is at least one of substantially elongate, substantially helical, substantially tapered, and substantially coiled with a solid substantially tapered inner core.

19. The catheter as in claim 7 wherein the member is made from at least one material selected from the group consisting of stainless steel, nitinol, and plastic.

20. The catheter as in claim 7 wherein at least one of the shaft, stem, tip, member, and lumen is at least one of formed from, co-extruded with, and coated with a lubricious material or a hydrophilic material.

21. The catheter as in claim 20 wherein the lubricious material is selected from the group consisting of nylon, Rilsan®

nylon, polytetrafluoroethylene (PTFE), PEBAX®

material, PEEK, polyimide, polyethylene of varying densities, PE, PET, PU, HDPE, and fluorinated ethylene propylene.

22. The catheter as in claim 7, wherein at least one of the shaft, at least one of the lumens, and the core wire are tapered in diameter.

23. The catheter as in claim 7, wherein the catheter is an over-the-wire catheter.

24. The catheter as in claim 7, wherein the catheter is a rapid exchange catheter.

25. The catheter as in claim 7, wherein a distal portion of the shaft has a recess that extends around a circumference thereof and that is substantially flush with a second recess that extends around a circumference of a proximal portion of the stem around which the inflation balloon is positioned to form a first junction, and wherein a distal portion of the stem has a third recess that extend s around a circumference thereof that is substantially flush with a fourth recess that extends around a circumference of a proximal portion of the tip to form a second junction, wherein the junctions have a substantially low profile and wherein proximal and distal ends of the balloon are secured in the junctions.

26. The catheter as in claim 25, wherein the junctions have a substantially zero profile.

27. The catheter as in claim 11, wherein the tab is at least one of an integrated tab that is integral with a portion of the connector, a detachable tab that is detachable from the connector, and a tab having a member that is configured for insertion into a substantially complementary slot in the connector.

28. A catheter comprising:

a connector having at least one of an inflation channel, at least one core wire channel, and a guidewire channel;

an inflatable balloon having proximal and distal ends;

a flexible tip;

at least one retractable core wire comprising a substantially stiff member having proximal and distal ends;

a first tubular member configured for connection at a proximal end with the connector and having a lumen in fluid communication with the inflation channel of the connector and the balloon, and configured for connection at a distal end with the inflatable balloon;

at least one second tubular member configured for connection at a proximal end with the connector and having a lumen configured for disposition of the retractable core wire therein and in fluid communication with the core wire channel of the connector, wherein a length of the retractable core wire is substantially equal to or less than a length of the lumen of the second tubular member;

a third tubular member having a lumen in fluid communication with the guidewire channel of the connector and configured for connection at a proximal end with the connector and for disposition of a guidewire therein; and

a sheath surrounding the tubular members.

29. The catheter as in claim 28, wherein the retractable core wire further comprises a tab coupled to at least one of the proximal end and a proximal portion of the substantially stiff member, wherein the tab facilitates retraction and extension of the member within the lumen of the second tubular member.

30. The catheter as in claim 28, wherein at least one of the tubular members, lumens, and retractable core wire is at least one of formed from, co-extruded with, or coated with a lubricious material or a hydrophilic material.

31. The catheter as in claim 30, wherein the lubricious material is selected from the group consisting of nylon, Rilsan®

nylon, polytetrafluoroethylene (PTFE), PEBAX®

material, PEEK, polyimide, polyethylene of varying densities, PE, PET, PU, HDPE, and fluorinated ethylene propylene.

32. The catheter as in claim 28, wherein the tubular members are substantially parallel to each other.

33. The catheter as in claim 28, wherein at least one second tubular member is substantially concentrically positioned around the first tubular member.

34. The catheter as in claim 28, wherein at least one of the second tubular member and the core wire is at least one of substantially elongate, substantially helical, substantially tapered, and substantially coiled.

35. The catheter as in claim 28, wherein at least one second tubular member extends at least partially through the stem or tip.

36. A catheter comprising:

a connector having at least one channel;

a shaft having a proximal end connected to the connector, a first recess that extends around a circumference of a distal portion of the shaft, an inflation lumen in fluid communication with the channel of the connector and an inflatable balloon, and a guidewire lumen that is configured for disposition of a guidewire therein and in fluid communication with a channel of the connector;

a stem having a stem guidewire lumen portion configured for disposition of the guidewire therein and in fluid communication with the guidewire lumen, a second recess that extends around a circumference of a proximal portion of the stem and a third recess that extends around a circumference of a distal portion of the stem, wherein the first and second recesses are substantially flush to form a first junction;

a tip having a tip guidewire lumen portion configured for disposal of the guidewire and in fluid communication with the stem guidewire lumen portion and a fourth recess that extends around a circumference of a proximal portion of the tip, wherein the third and fourth recesses are substantially flush with each other to form a second junction; and

an inflatable balloon positioned substantially around the exterior of the stem, wherein a proximal end of the balloon is adhered substantially in the first junction and a distal end of the balloon is substantially adhered in the second junction, wherein the junctions have substantially low profile bonds.

37. The catheter as in claim 36, wherein the low profile bonds are substantially zero profile bonds.

38. The catheter as in claim 36, wherein at least one of the shaft, stem, tip, and lumen is at least one of formed from, co-extruded with, and coated with a lubricious material or hydrophilic material.

39. The catheter as in claim 38, wherein the lubricious material is selected from the group consisting of nylon, Rilsan®

nylon, polytetrafluoroethylene (PTFE), PEBAX®

material, PEEK, polyimide, polyethylene of varying densities, PE, PET, PU, HDPE, and fluorinated ethylene propylene.

40. The catheter as in claim 36, further comprising at least one core wire.

41. A method of using a catheter comprising at least one retractable core wire and a shaft having proximal and distal ends, an inflation lumen configured for communication with an inflatable balloon, at least one core wire lumen configured for disposition of the retractable core wire therein, and a guidewire lumen configured for disposition of a guidewire therein, the method comprising the steps of:

inserting a guidewire into a vessel;

advancing the guidewire in a distal direction within the vessel to a target site in the vessel;

advancing the catheter into the vessel by inserting the guidewire into the guidewire lumen to a tortuous region within the vessel; and

retracting the retractable core wire in a proximal direction or extending the core wire in a distal direction within the core wire lumen to adjust the stiffness of the shaft, wherein the stiffness of the shaft facilitates movement of the catheter through the tortuous region.

42. The method of claim 41 further comprising the step of removing the retractable core wire from the core wire lumen.