CATHETER SYSTEM AND METHODS OF USING SAME

• US 20100004730A1
• Filed: 07/01/2009
• Published: 01/07/2010
• Est. Priority Date: 07/01/2008
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Endologix
• Inventors: Schreck, Stefan, Benjamin, Joshua
• Granted Patent: US 8,216,295 B2
• Time in Patent Office: Days
• 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 a main body, a tubular introducer sheath projecting from the main body, and a first seal supported within the introducer;

a catheter comprising a main body, a outer sheath projecting from the main body, a second seal supported within the catheter, and an inner core that is advanceable through the main body, the second seal, and the outer sheath;

wherein;

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

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

the introducer sheath is configured to axially receive at least the inner core therethrough and to be selectively engageable with the catheter so that the catheter can be selectively and removably linked with the introducer in the axial direction such that, when the introducer and the catheter are linked, the axial movement of either of the introducer and the catheter will cause the simultaneous and equal axial movement of the other of the introducer and the catheter; and

the catheter system is configured such that, when the introducer and the catheter are linked, the catheter is rotatable relative to the introducer.

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

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 introducer sheath when the catheter is axially engaged with the introducer.

4. The catheter system of claim 1, wherein the outer sheath defines a proximal end portion supported by the main body of the catheter and a distal end portion, and the introducer sheath defines a proximal end portion supported by the main body of the introducer and a distal end portion, and the introducer sheath is configured to directly radially restrain a stent that is axially supported by the catheter after the stent has been axially advanced past the distal end portion of the outer sheath and the proximal end portion of the introducer sheath.

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

6. The catheter system of claim 5, wherein the introducer sheath is configured to directly radially restrain a stent that is axially supported by the catheter after the stent 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 introducer sheath.

8. The catheter system of claim 1, wherein the catheter further comprises a central tube axially supported by and projecting from the inner core, the central tube being configured to support a stent thereon, the catheter being configured such that the central tube and the stent 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 one or more tabs supported by the central tube, the one or more tabs being configured to provide axial support to the stent that is supported by the catheter when the stent 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 a stent can be transferred from the outer sheath into the introducer sheath as the stent is advanced into the introducer.

12. The catheter system of claim 1, wherein the outer sheath and the introducer sheath form a lumen having a substantially uniform cross-sectional size through the catheter system through which a stent 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 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 and axially retracting the catheter away from the introducer.

16. The catheter system of claim 1, wherein the first seal is an adjustable hemostasis valve.

17. The catheter system of claim 1, 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.

18. The catheter system of claim 1, 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.

19. A catheter system comprising:

an introducer comprising a main body and an introducer sheath projecting from the main body;

a catheter comprising a main body, a outer sheath projecting from the main body, and an inner core that is advanceable through the main body and the outer sheath;

wherein;

the inner core is configured to axially support a stent such that the stent can be advanced through the outer sheath by advancing the inner core through the outer sheath;

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 such that the outer sheath of the catheter does not advance into the introducer sheath when the catheter is fully axially advanced into the introducer; and

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

20. The catheter system of claim 19, wherein the introducer is 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 such that, when the introducer and the catheter are linked, the axial movement of either of the introducer and the catheter will cause the simultaneous and equal axial movement of the other of the introducer and the catheter.

21. The catheter system of claim 19, wherein the catheter system is configured such that, when the introducer and the catheter are linked, the catheter is rotatable relative to the introducer.

22. The catheter system of claim 19, wherein an inner diameter of the outer sheath is approximately the same as an inner diameter of the introducer sheath.

23. The catheter system of claim 19, wherein the introducer comprises an adjustable hemostasis valve.

24. A method of deploying a stent in a blood vessel, comprising:

positioning an introducer within a patient'"'"'s blood vessel so as to advance an introducer sheath of the introducer into the patient'"'"'s blood vessel, the introducer having a proximal end portion and a distal end portion;

advancing an outer sheath of a catheter into the introducer so that an end portion of the outer sheath of the catheter is positioned approximately adjacent to the proximal end portion of the introducer sheath and such that no portion of the outer sheath overlaps the introducer sheath, the catheter further comprising an inner core that is axially moveable within the outer sheath;

axially supporting a stent with the inner core;

axially advancing the inner core and the stent through the outer sheath of the catheter, through the introducer sheath, and past the distal end of the introducer sheath; and

deploying the stent in the blood vessel.

25. The method of deploying a stent of claim 24, further comprising selectively axially engaging the catheter with the introducer such so as to removably link the catheter to the introducer in the axial direction.

26. The method of deploying a stent of claim 25, further comprising rotating the catheter relative to the introducer so as to change the rotational orientation of the catheter relative to the introducer without disengaging the catheter from the introducer.