Catheter system and methods of using same

• US 9,700,701 B2
• Filed: 07/09/2012
• Issued: 07/11/2017
• Est. Priority Date: 07/01/2008
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Endologix
• Inventors: Benjamin, Joshua, Schreck, Stefan
• Primary Examiner(s): Weisberg, Amy R
• Application Number:
  US13/544,426
• Publication Number:
  US 20120277847A1
• Time in Patent Office: 1,828 Days
• Field of Search: 606108, 606194, 606200, 606190-191, 606184-185, 623 111- 154, 600585
• 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 a main body and a tubular introducer sheath projecting from the main body;

a catheter comprising a main body and an outer sheath projecting from the main body, the outer sheath configured to be at least partially advanced through the main body of the introducer;

a locking element configured to selectively lock the catheter to the introducer in an axial direction such that, when the introducer and the catheter are axially locked, axial movement of either of the introducer and the catheter in a proximal or a distal direction will cause the simultaneous and equal axial movement of the other of the introducer and the catheter so as to prevent the movement of either of the introducer and the catheter relative to the other of the introducer and the catheter; and

a stent or a stent graft axially supported by the catheter in a predeployment state;

wherein the locking element is configured such that, when the introducer and the catheter are axially locked, there is rotational freedom between the catheter and the introducer;

wherein the locking element is configured to axially lock the catheter to the introducer while the stent or the stent graft is released from the catheter system.

2. The catheter system of claim 1, wherein the catheter is configured to deploy the stent or the stent graft.

3. The catheter system of claim 1, wherein the catheter system is configured such that the outer sheath of the catheter does not overlap any portion of the tubular introducer sheath when the catheter is axially engaged with the introducer.

4. The catheter system of claim 1, wherein the outer sheath comprises a proximal end portion and a distal end portion, and the tubular introducer sheath comprises a proximal end portion and a distal end portion, and the tubular introducer sheath is configured to directly radially restrain the stent or the stent graft after the stent or the stent graft has been axially advanced past the distal end portion of the outer sheath and the proximal end portion of the tubular introducer sheath.

5. The catheter system of claim 1, wherein the outer sheath comprises a proximal end portion and a distal end portion, and the tubular introducer sheath comprises 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 tubular introducer sheath when the catheter is axially engaged with the introducer.

6. The catheter system of claim 5, wherein the tubular introducer sheath is configured to directly radially restrain the stent or the stent graft that is axially supported by the catheter after the stent or the stent graft has been axially advanced past the distal end portion of the outer sheath.

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

8. The catheter system of claim 1, wherein the catheter further comprises an inner core configured to be advanceable through the main body of the catheter and the outer sheath, and wherein the catheter further comprises a central tube axially supported by and projecting from the inner core, the central tube being configured to support the stent or the stent graft thereon, the catheter being configured such that the central tube and the stent or the stent graft are axially advanceable through at least the main body of the catheter and the outer sheath of the catheter by axially advancing the inner core.

9. The catheter system of claim 8, further comprising the stent or the stent graft supported on the central tube and one or more tabs supported by the central tube, the one or more tabs being configured to provide axial support to the stent or the stent graft that is supported by the catheter when the stent or the stent graft is in a collapsed configuration.

10. The catheter system of claim 8, wherein the catheter further comprises a distal tip supported by an end portion of the central tube, and both the distal tip and the central tube have an opening therethrough configured to receive a guidewire.

11. The catheter system of claim 1, wherein the catheter system is configured such that the stent or the stent graft can be transferred from the outer sheath into the tubular introducer sheath as the stent or the stent graft is advanced into the introducer.

12. The catheter system of claim 1, wherein the outer sheath and the tubular introducer sheath form a lumen having a substantially uniform cross-sectional size through the catheter system through which the stent or the stent graft can be advanced.

13. The catheter system of claim 12, wherein the lumen is substantially continuous along a length thereof.

14. The catheter system of claim 1, wherein the catheter comprises at least one deflectable tab supported by the main body of the catheter 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 catheter with the introducer.

15. The catheter system of claim 14, wherein the catheter can be disengaged from the introducer by deflecting the at least one deflectable tab radially inwardly toward an axial centerline of the catheter and axially retracting the catheter away from the introducer.

16. The catheter system of claim 1, wherein the catheter further comprises:

an inner core that is advanceable through the main body of the catheter and the outer sheath;

a first seal supported within the introducer; and

a second seal supported within the catheter;

wherein;

the inner core that is advanceable through the second seal;

the first seal is configured to at least inhibit a flow of blood through the introducer when the catheter is engaged with the introducer; and

the second seal is configured to at least inhibit a flow of blood through the catheter.

17. The catheter system of claim 16, wherein the first seal is an adjustable hemostasis valve.

18. The catheter system of claim 16, wherein the first seal is created by a close tolerance fit between the outer sheath and an inside surface of the main body of the introducer.

19. The catheter system of claim 16, wherein the second seal is created by a close tolerance fit between the inner core and an inside surface of the main body of the catheter.

20. The catheter system of claim 1,

wherein the catheter further comprises at least one deflectable tab supported by the main body of the catheter, the at least one deflectable tab configured to selectively engage the introducer by distally advancing a distal free end of each of the at least one deflectable tab into a proximal end of the main body of the introducer;

and

wherein the catheter is configured to be disengaged from the introducer by deflecting the at least one deflectable tab radially inwardly toward the axial centerline of the catheter.

21. The catheter system of claim 1, wherein the catheter further comprises an inner core configured to be advanceable through the main body of the catheter, and wherein when the introducer and the catheter are axially locked, the inner core is rotatable relative to the main body of the catheter and the introducer.

22. The catheter system of claim 1, wherein when the introducer and the catheter are axially locked, a distal end of the outer sheath is proximal to the tubular introducer sheath.

23. The catheter system of claim 1, wherein when the introducer and the catheter are axially locked the catheter is freely rotatable relative to the introducer to allow for precise rotational positioning of the catheter within the introducer.

24. The catheter system of claim 1, wherein the catheter is configured to permit a user to selectively control or prevent the rotational freedom of the catheter relative to the introducer.