Catheter and method for a stent delivery system

• US 6,217,586 B1
• Filed: 08/27/1999
• Issued: 04/17/2001
• Est. Priority Date: 04/21/1997
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Mackenzie, Andrew James
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US09/384,923
• Time in Patent Office: 599 Days
• Field of Search: 606/108, 606/192, 606/193, 606/194, 606/198, 606/200, 623/1.11
• US Class Current: 606/108
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially

Abstract

An apparatus and method for deploying one or more stents within a body lumen comprises a catheter (such as a dilatation catheter) having a detachable proximal portion. Detaching the proximal portion from the catheter shaft allows a substantially tubular sheath to be slidably received over the proximal end of the catheter shaft. The tubular sheath has one or more substantially tubular stents positioned in a delivery configuration over a distal portion of the sheath. The sheath preferably has a proximal portion that is resistant to compressive forces, so that a user may advance the sheath along the catheter by pushing the sheath proximal end, thereby positioning the stent or stents at a desired deployment location within the body lumen. With the stents in position, the catheter proximal portion can be attached to the catheter shaft, and the stents can be deployed at the desired position. After the stents have been deployed, the catheter proximal hub can be removed, the first sheath slidably removed from the catheter shaft, a second sheath (containing additional stents) slidably introduced over the catheter shaft, the catheter proximal hub reattached, and the additional stents deployed. Thus, multiple stents can be deployed without necessitating removal of the catheter shaft until the procedure is completed.

Claims

1. A catheter assembly, comprising:

a shaft having an outer surface, a central axis, a proximal end, and a distal end;

a substantially tubular sheath of substantially equal length to the shaft and slidably disposed over the shaft; and

a detachable, seamless proximal hub removably secured to the proximal end of the shaft to retain the sheath thereon wherein the proximal end of the shaft engages the hub through a distal bore of the hub.

2. The catheter of claim 1, wherein the shaft distal end includes an expandable member.

3. The catheter of claim 2, wherein the detachable proximal hub includes a control device for controlling expansion of the expandable member.

4. The catheter of claim 1, wherein the shaft proximal end has a diameter, and the detachable proximal hub has a diameter greater than the diameter of the shaft proximal end.

5. The catheter of claim 1, wherein the detachable proximal hub comprises:

a base element having a first threaded element;

a first nose cap having a threaded element and a central bore sized to receive the catheter shaft, said first nose cap threaded element configured to be threadably secured to the base element first threaded element; and

a first compression fitting adjacent the base element and first nose cap.

6. The catheter of claim 5, wherein the first compression fitting is formed of a substantially compressible material.

7. The catheter of claim 6, wherein the first compression fitting comprises a substantially annular element having a central bore sized to receive the catheter shaft.

8. The catheter of claim 5, wherein the catheter is a rapid-exchange catheter.

9. The catheter of claim 5, wherein the catheter shaft comprises an inner member and an outer member.

10. The catheter of claim 9, wherein the proximal hub base element further includes a second threaded element, the first nose cap central bore is sized to receive the catheter shaft outer member, and the catheter further comprises:

a second nose cap having a threaded element, said second nose cap threaded element configured to be threadably secured to the base element second threaded element; and

a second compression fitting adjacent the base element and second nose cap.

11. The catheter of claim 10, wherein the first threaded element of the proximal hub base element is located at a distal end of the proximal hub, and the second threaded element of the proximal hub base element is located at a proximal end of the proximal hub.

12. The catheter of claim 10, wherein the catheter is an over-the-wire catheter.

13. The catheter of claim 1, further comprising:

a first set of one or more projections on the detachable proximal hub; and

a first set of one or more apertures on the catheter shaft, said first set of shaft apertures sized and configured to receive said first set of proximal hub projections.

14. The catheter of claim 13, wherein the first set of shaft apertures each comprises an annular groove.

15. The catheter of claim 13, wherein the proximal hub includes a central bore sized to receive the catheter shaft, the first set of proximal hub projections are located within the central bore, and the first set of shaft apertures are located on an outer surface of the shaft.

16. The catheter of claim 13, wherein the catheter shaft includes an inner surface defining a central lumen sized and configured to slidably receive a distal portion of the proximal hub, the first set of proximal hub projections are located on the proximal hub distal portion, and the first set of shaft apertures are located on the inner surface of the catheter shaft.

17. The catheter of claim 13, wherein the catheter shaft comprises a first element and a second element, and the first set of catheter shaft apertures are located on the catheter shaft first element, wherein the catheter further comprises:

a second set of one or more projections on the detachable proximal hub; and

a second set of one or more apertures on the catheter shaft, said second set of shaft apertures positioned on the catheter shaft second element and sized and configured to receive said second set of proximal hub projections.

18. The catheter of claim 17, wherein the catheter shaft first element and catheter shaft second element comprise coaxial shafts.

19. The catheter of claim 1, further comprising:

a first set of one or more projections extending from the shaft; and

a first set of one or more apertures in the detachable proximal hub, said first set of proximal hub apertures sized and configured to receive said first set of shaft projections.

20. The catheter of claim 19, wherein the catheter shaft includes an inner surface defining a central lumen sized and configured to slidably receive a distal portion of the proximal hub, the first set of proximal hub apertures are located on the proximal hub distal portion, and the first set of catheter shaft projections are located on the inner surface of the catheter shaft.

21. A stent deployment system for deploying one or more stents within a body lumen, the system comprising:

a substantially tubular sheath having a length a proximal end and a distal end, a proximal portion and a distal portion, an outer surface, and a lumen therethrough defining an inner surface; and

a substantially tubular stent having a delivery configuration and a deployed configuration, the stent being removably attached in the delivery configuration over the distal portion of the sheath; and

a catheter having;

a shaft with a length substantially equal to the length of the sheath, an outer surface, a central axis, a proximal end, and a distal end, said shaft configured to be slidably received within the lumen of the tubular sheath; and

a detachable, seamless proximal hub having a distal end, the removable proximal hub removably secured at its distal end to the proximal end of the shaft wherein the proximal end of the shaft engages the hub through a distal bore of the hub.

22. The system of claim 21, wherein the catheter shaft includes an expandable member at the shaft distal end.

23. The system of claim 22, wherein the detachable proximal hub includes a control device for controlling expansion of the expandable member.

24. The system of claim 21, further comprising:

a securing device that prevents rotation of the detachable proximal hub about the shaft axis when the detachable proximal hub is secured to the shaft.

25. The system of claim 21, wherein the shaft proximal end has a diameter, and the sheath is configured for slidable movement over the shaft proximal end.

26. The system of claim 25, wherein the detachable proximal hub has a diameter greater than the diameter of the shaft proximal end.

27. The system of claim 21, wherein the catheter is an over-the-wire catheter.

28. The system of claim 21, wherein the catheter is a rapid-exchange catheter.

29. The system of claim 21, wherein the expandable member is a dilatation balloon.

30. A stent deployment system for deploying one or more stents within a body lumen, the system comprising:

a substantially tubular sheath having a length, a proximal end and a distal end, a proximal portion and a distal portion, an outer surface, a lumen therethrough defining an inner surface, and a length; and

a substantially tubular stent having a delivery configuration and a deployed configuration, the stent being removably attached in the delivery configuration over the distal portion of the sheath; and

a catheter having;

a shaft with an outer surface, a central axis, a proximal end, and a distal end, the shaft configured to be slidably received within the lumen of the tubular sheath; and

a seamless extender section of the catheter shaft, said extender section removably secured at a distal end thereof to the proximal end of the catheter shaft, the extender section configured to be slidably received within the lumen of the tubular sheath, and wherein the length of the shaft and extender section is substantially equal to the length of the sheath.

31. The system of claim 30, wherein the extender section has a length that is longer than the length of the tubular sheath.

32. The system of claim 31, wherein the catheter has an expandable member at the catheter distal end, and the extender section includes a control device for controlling expansion of the expandable member.