Catheter system and methods of using same

• US 8,216,295 B2
• Filed: 07/01/2009
• Issued: 07/10/2012
• Est. Priority Date: 07/01/2008
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Endologix
• Inventors: Benjamin, Joshua, Schreck, Stefan
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): SHIPLEY, AMY R
• Application Number:
  US12/496,446
• Publication Number:
  US 20100004730A1
• Time in Patent Office: 1,105 Days
• Field of Search: None
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61M 2025/0006 which can be secured against axial movement, e.g. by using a locking cuff
• CPC Class Codes: A61M 2025/0079 Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

Some embodiments are directed to a catheter system comprising an introducer having a main body, an introducer sheath projecting from the main body, and a first seal supported within the introducer and a catheter having a main body, an outer sheath projecting from the main body, a second seal supported within the catheter, and an inner core configured to be advanced axially through the main body, the second seal, and the outer sheath. The introducer can be configured to be selectively engageable with the catheter so that the catheter can be selectively and removably linked with the introducer in the axial direction. The catheter system can also be configured such that, when the introducer and the catheter are linked, the catheter can be rotatable relative to the introducer. The introducer can be configured to radially restrain an endoluminal prosthesis.

Claims

1. A catheter system comprising:

an introducer comprising an introducer main body and an introducer sheath projecting from the introducer main body, the introducer sheath having an introducer lumen extending therethrough;

a delivery catheter comprising a delivery catheter main body, an outer sheath projecting from the delivery catheter main body having a delivery catheter lumen therethrough, and an inner core configured to advance through the delivery catheter lumen; and

a stent having a lumen axially therethrough supported about an outside surface of a distal end portion of the inner core;

wherein;

the inner core axially supports the stent such that, in use, advancing the inner core through the delivery catheter lumen simultaneously advances the stent through the outer sheath delivery catheter lumen;

the outer sheath is configured to radially restrain the stent;

the introducer sheath is configured to axially receive at least the inner core therein;

the catheter system is configured to prevent the outer sheath of the delivery catheter from advancing into the introducer sheath when the delivery catheter has reached a fully advanced position in the introducer; and

the introducer sheath is configured to directly radially restrain the stent while the stent is positioned within the introducer sheath.

2. The catheter system of claim 1, wherein the introducer is configured to be selectively engageable with the delivery catheter so that the delivery catheter can be selectively and removably linked with the introducer in the axial direction such that, when the introducer and the delivery catheter are linked, the axial movement either the introducer or the delivery catheter will cause the simultaneous and equal axial movement of the other of the introducer and the delivery catheter in both axial directions.

3. The catheter system of claim 2, wherein the catheter system is configured such that, when the introducer and the delivery catheter are linked, the delivery catheter is rotatable relative to the introducer.

4. The catheter system of claim 1, wherein an inner diameter of the outer sheath is approximately the same as an inner diameter of the introducer sheath.

5. The catheter system of claim 1, wherein the introducer comprises an adjustable hemostasis valve.

6. The catheter system of claim 1, further comprising a stent supported by the inner core, wherein the stent is tubular, bifurcated, and/or fenestrated and comprises a graft.

7. The catheter system of claim 1, wherein an inner surface of the introducer sheath is coated with a low-friction coating.

8. The catheter system of claim 1, wherein the delivery catheter has threads on an external surface thereof.

9. The catheter system of claim 1, wherein a proximal end portion of the introducer sheath is flared such that an inner diameter of the introducer sheath is larger in the proximal end portion of the introducer sheath than an inner diameter of the introducer sheath distal to the proximal end portion of the introducer sheath.

10. The catheter system of claim 1, wherein the introducer comprises a constricted portion distal to or adjacent to a distal end of the outer sheath of the catheter.

11. The catheter system of claim 1, wherein the outer sheath defines a proximal end portion and a distal end portion, and the introducer sheath further defines a proximal end portion, and the distal end portion of the outer sheath is positioned approximately adjacent to the proximal end portion of the introducer sheath when the delivery catheter is axially engaged with the introducer.

12. The catheter system of claim 1, wherein:

the delivery catheter further comprises a central tube axially supported by and projecting from the inner core;

the central tube comprises one or more tabs projecting from an outside surface of the central tube;

the one or more tabs are configured to provide axial support to a stent that is supported in a collapsed configuration on the central tube; and

the delivery catheter is configured such that the central tube and the stent are axially advanceable through at least the delivery catheter main body and the outer sheath of the delivery catheter by axially advancing the inner core.

13. The catheter system of claim 1, wherein the catheter system is configured such that a stent can be transferred from the outer sheath into the introducer sheath as the inner core is advanced into the introducer.

14. The catheter system of claim 1, wherein the delivery catheter comprises at least one deflectable tab and the introducer comprises at least one flange, and the at least one deflectable tab is configured to selectively engage with the at least one flange so as to axially engage the delivery catheter with the introducer, and the delivery catheter can be disengaged from the introducer by deflecting the at least one deflectable tab radially inwardly and axially retracting the delivery catheter away from the introducer.

15. The catheter system of claim 1, wherein:

the introducer comprises a constricted portion distal to or adjacent to a distal end of the outer sheath of the delivery catheter.

16. The catheter system of claim 15, wherein an inner diameter of the outer sheath is approximately the same as an inner diameter of at least a distal portion of the introducer sheath.

17. The catheter system of claim 15, wherein the catheter system is configured such that a stent can be transferred from the outer sheath into the introducer sheath as the inner core is advanced into the introducer.

18. The catheter system of claim 15, further comprising a stent supported by the inner core, wherein the stent comprises at least one of a tubular, bifurcated, and fenestrated stent graft.

19. The catheter system of claim 15, wherein the outer sheath defines a proximal end portion and a distal end portion, and the introducer sheath defines a proximal end portion and a distal end portion, and the distal end portion of the outer sheath is positioned approximately adjacent to the proximal end portion of the introducer sheath when the delivery catheter is axially engaged with the introducer.

20. The catheter system of claim 15, wherein:

the delivery catheter further comprises a central tube axially supported by and projecting from the inner core;

the central tube comprises one or more tabs projecting from an outside surface of the central tube;

the one or more tabs are configured to provide axial support to a stent that is supported in a collapsed configuration on the central tube; and

the delivery catheter is configured such that the central tube and the stent are axially advanceable through at least the delivery catheter main body and the outer sheath of the delivery catheter by axially advancing the inner core.

21. The catheter system of claim 15, wherein the delivery catheter has threads on an external surface thereof.

22. The catheter system of claim 15, wherein the introducer sheath has a flared proximal end portion.

23. The catheter system of claim 1, wherein:

an inner diameter of the outer sheath is approximately the same as an inner diameter of at least a distal portion of the introducer sheath.

24. The catheter system of claim 22, wherein the catheter system is configured such that a stent can be transferred from the outer sheath into the introducer sheath as the inner core is advanced into the introducer.

25. The catheter system of claim 22, further comprising a stent supported by the inner core, wherein the stent is tubular, bifurcated, and/or fenestrated.

26. The catheter system of claim 22, wherein the outer sheath defines a proximal end portion and a distal end portion, and the introducer sheath defines a proximal end portion and a distal end portion, and the distal end portion of the outer sheath is positioned approximately adjacent to the proximal end portion of the introducer sheath when the delivery catheter is axially engaged with the introducer.

27. The catheter system of claim 22, wherein:

the delivery catheter further comprises a central tube axially supported by and projecting from the inner core;

the central tube comprises one or more tabs projecting from an outside surface of the central tube;

the one or more tabs are configured to provide axial support to a stent that is supported in a collapsed configuration on the central tube; and

the delivery catheter is configured such that the central tube and the stent are axially advanceable through at least the delivery catheter main body and the outer sheath of the delivery catheter by axially advancing the inner core.

28. The catheter system of claim 22, wherein the delivery catheter comprises threads on an external surface thereof.

29. The catheter system of claim 22, wherein the introducer sheath has a flared proximal end portion.

30. The catheter system of claim 1, wherein the introducer sheath has a flared proximal end portion.

31. The catheter system of claim 30, wherein an inner diameter of the outer sheath is approximately the same as an inner diameter of at least a distal portion of the introducer sheath.

32. The catheter system of claim 1, wherein:

the delivery catheter further comprises a central tube axially supported by and projecting from the inner core;

the central tube comprises one or more tabs projecting from an outside surface of the central tube;

the one or more tabs are configured to provide axial support to a stent that is supported in a collapsed configuration on the central tube; and

the delivery catheter is configured such that the central tube and the stent are axially advanceable through at least the delivery catheter main body and the outer sheath of the delivery catheter by axially advancing the inner core.

33. The catheter system of claim 1, wherein:

the introducer comprises a first docking mechanism and the delivery catheter defines a second docking mechanism removably engageable with the first docking mechanism; and

in use, when the second docking mechanism of the delivery catheter is engaged with the first docking mechanism of the introducer, axially moving either the introducer or the delivery catheter in either axial direction will cause the simultaneous and equal axial movement of the other of the introducer and the delivery catheter.

34. The catheter system of claim 1, wherein:

the introducer comprises a flange;

the delivery catheter comprises a deflectable tab selectively engageable with the flange; and

in use, when the deflectable tab is engaged with the flange, axially moving either the introducer or the delivery catheter in either axial direction will cause the simultaneous and equal axial movement of the other of the introducer and the delivery catheter.

35. The catheter system of claim 1, wherein a proximal end portion of an inner diameter of the introducer sheath is flared.

36. The catheter system of claim 12, wherein the central tube has a smaller outer diameter than the inner core.