Catheter with removable balloon protector and stent delivery system with removable stent protector

• US 6,152,944 A
• Filed: 03/04/1998
• Issued: 11/28/2000
• Est. Priority Date: 03/05/1997
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Eidenschink, Tracee E. J., Holman, Thomas J., Hanson, Scott M., Ellis, Louis G., Traxler, Richard J., Olson, Gregory K., Lorentzen Cornelius, Linda R., Williams, Sonja J. K.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Lewis, William W.
• Application Number:
  US09/034,434
• Time in Patent Office: 1,000 Days
• Field of Search: 606/1, 606/108, 606/191, 606/194, 606/195, 606/198, 606/200, 604/96, 623/1, 623/12
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A balloon catheter is provided having an expandable distal portion and balloon protector means comprising a first removable sleeve having a variable inner diameter to ease sliding the first sleeve over the balloon, and an optional second removable (outer) sleeve positioned over the inner sleeve, the second (outer) sleeve having a constrictive relationship with the first (inner) sleeve, said first and second sleeves being removed prior to use of the catheter. A stent delivery system is provided to facilitate introduction and placement of a stent, and includes a catheter having an expandable distal portion constructed and arranged for expanding the outer diameter of the catheter from a contracted state to an expanded state, said distal portion further comprising a balloon and at least one dam over which the balloon extends, and a stent positioned around the distal portion of the catheter around the balloon or gripper linear control device, said stent having a contracted condition, being sized in the contracted condition to closely surround the balloon in the contracted state, and being expandable to an expanded condition; a first removable (inner) sleeve in the region of the distal portion of the catheter positioned around the stent (and between the dams where the device comprises two dams), said first sleeve comprising a first end, a second end and a variable inner diameter to ease sliding the sleeve over the balloon and stent; an optional second removable (outer) sleeve positioned over the stent, first sleeve and at least one dam, said second (outer) sleeve having a constrictive relationship with the first (inner) sleeve, whereby when compressed by the outer sleeve, the inner sleeve will have an inner diameter approximately equal to or less than the outer profile of the collapsed balloon over the at least one dam, said first and second sleeves being removed prior to use of the stent delivery system and release of the stent by expansion of the balloon.

Claims

1. A stent delivery system comprising:

a catheter comprising a proximal portion, a distal portion, a shaft and an expandable member located at the distal portion, said expandable member having a first end and a second end and being constructed and arranged for expanding the outer diameter of said catheter from a contracted state to an expanded state;

a radially expandable stent of generally cylindrical configuration positioned around said distal portion of said catheter around the expandable member, said stent having a contracted condition, being sized in the contracted condition to closely surround the catheter in the contracted state, and further being expandable to an expanded condition;

removable stent protector means comprising a first removable sleeve in the region of the distal portion of the catheter positioned around the stent, said first sleeve further comprising a first end, and a second end, said first sleeve having a variable inner diameter to ease sliding the first sleeve over the ballon and stent, said stent protector means being removed prior to use of the stent delivery system and release of the stent by expansion of the balloon, wherein the stent protector means further comprises a second removable sleeve having a first and a second end, said second sleeve being positioned over the first sleeve and having a constrictive relationship with said first sleeve.

2. The stent delivery system of claim 1 wherein at least one of said first sleeve and second sleeve is a continuous tube.

3. The stent delivery system of claim 2 wherein at least a portion of said at least one continuous tube is dimpled.

4. The stent delivery system of claim 3 wherein the entire continuous tube is dimpled.

5. The stent delivery system of claim 3 wherein the dimples are round-like.

6. The stent delivery system of claim 3 wherein the dimples are helical grooves.

7. The stent delivery system of claim 3 having round-like dimples and helical dimples.

8. The stent delivery system of claim 2 wherein said at least one straight tube further comprises a proximal flare.

9. The stent delivery system of claim 1 wherein at least one of said first and second sleeves has a slit extending therethrough.

10. The stent delivery system of claim 9 wherein the slit is a longitudinal slit extending from the first end of the sleeve to the second end of the sleeve.

11. The stent delivery system of claim 9 wherein the slit is a spiral slit extending in a helical manner from the first end of the sleeve to the second end of the sleeve.

12. The stent delivery system of claim 9 wherein the slit extends distally in a helical manner from the first end of the sleeve and defines a proximal spiral region, said sleeve further comprising a distal continuous tubular portion.

13. The stent delivery system of claim 12 wherein at least a portion of the distal continuous tubular portion further comprises a dimpled region.

14. The stent delivery system of claim 13 wherein the dimpled region has round-like dimples.

15. The stent delivery system of claim 13 wherein the dimpled region has dimpled helical grooves.

16. The stent delivery system of claim 1 wherein the expandable member comprises a balloon made of an elastomeric material.

17. A system for intraluminal delivery of a stent comprising:

a balloon catheter comprising a shaft, a balloon associated with a distal portion of the shaft for receiving a stent, the shaft further comprising at least one dam and an inflation lumen associated with the balloon for inflation thereof;

stent retaining means comprising a first removable sleeve for positioning around a stent and a second removable sleeve for positioning around the first sleeve such that the first sleeve is compressed by the second sleeve to an inner diameter less than or equal to the outer diameter of the at least one dams, said first and second sleeves being removed prior to use of the delivery system and release of a stent mounted to the catheter for delivery thereof by expansion of the balloon;

wherein the first sleeve is made of a lubricious material and further comprises a first end, a second end and a slit extending therethrough, said slit providing a variable inner diameter to ease sliding the first sleeve over a stent mounted on the balloon; and

the second sleeve has an inner diameter, prior to mounting on the catheter, less than the outer diameter of the first sleeve prior to mounting on the catheter, and wherein the slit extends distally in a helical manner from the first end of the sleeve and defines a proximal spiral region, said sleeve further comprising a distal continuous tubular portion.

18. The system of claim 17 wherein at least a portion of distal continuous tubular portion is dimpled.

19. The system of claim 18 wherein said dimpled portion has round-like dimples.

20. The system of claim 18 wherein said dimpled portion has dimpled helical grooves.

21. The system of claim 17 wherein one of said first and second sleeves comprises a coiled flat wire, spring wound without a gap between the coils thereof.

22. The system of claim 17 wherein at least one of said sleeves comprises a polymeric tube having a first end, a second end, and a variable inner diameter, wherein at least one of said ends is flared, said tube having a slit extending from the first end to the second end, enabling said sleeve to be peeled off the catheter.

23. A stent delivery system comprising:

a catheter comprising a proximal portion, a distal portion, a shaft and an expandable member located at the distal portion, said expandable member having a first end and a second end and being constructed and arranged for expanding the outer diameter of said catheter from a contracted state to an expanded state;

a radially expandable stent of generally cylindrical configuration positioned around said distal portion of said catheter around the expandable member, said stent having a contracted condition, being sized in the contracted condition to closely surround the catheter in the contracted state, and further being expandable to an expanded condition;

removable stent protector means comprising a first removable sleeve in the region of the distal portion of the catheter positioned around the stent, said first sleeve further comprising a first end, and a second end, said first sleeve having a variable inner diameter to ease sliding the first sleeve over the balloon and stent, said stent protector means being removed prior to use of the stent delivery system and release of the stent by expansion of the balloon, wherein the first sleeve is a straight continuous tube.

24. The medical device of claim 23 wherein at least a portion of the continuous tube is dimpled.

25. The medical device of claim 24 wherein the continuous tube has round-like dimples.

26. The medical device of claim 24 wherein the continuous tube has helical grooved dimples.

27. The medical device of claim 24 wherein the entire continuous tube is dimpled.

28. A stent delivery system comprising:

a catheter comprising a proximal portion, a distal portion, a shaft and an expandable member located at the distal portion, said expandable member having a first end and a second end and being constructed and arranged for expanding the outer diameter of said catheter from a contracted state to an expanded state;

a radially expandable stent of generally cylindrical configuration positioned around said distal portion of said catheter around the expandable member, said stent having a contracted condition, being sized in the contracted condition to closely surround the catheter in the contracted state, and further being expandable to an expanded condition;

removable stent protector means comprising a first removable sleeve in the region of the distal portion of the catheter positioned around the stent, said first sleeve further comprising a first end, and a second end, said first sleeve having a variable inner diameter to ease sliding the first sleeve over the balloon and stent, said stent protector means being removed prior to use of the stent delivery system and release of the stent by expansion of the balloon, wherein said first sleeve has a slit extending therethrough, and wherein the slit extends distally in a helical manner from the first end of the sleeve and defines a proximal spiral region, said sleeve further comprising a distal continuous tubular portion.

29. The medical device of claim 28 wherein the distal continuous tubular portion further comprises a dimpled region and a substantially smooth region.

30. The medical device of claim 29 wherein the dimples are round-like.

31. The medical device of claim 29 wherein the dimples are helical grooves.

32. A stent delivery system comprising:

a catheter comprising a proximal portion, a distal portion, a shaft and an expandable member located at the distal portion, said expandable member having a first end and a second end and being constructed and arranged for expanding the outer diameter of said catheter from a contracted state to an expanded state;

a radially expandable stent of generally cylindrical configuration positioned around said distal portion of said catheter around the expandable member, said stent having a contracted condition, being sized in the contracted condition to closely surround the catheter in the contracted state, and further being expandable to an expanded condition;

removable stent protector means comprising a first removable sleeve in the region of the distal portion of the catheter positioned around the stent, said first sleeve further comprising a first end, and a second end, said first sleeve having a variable inner diameter to ease sliding the first sleeve over the balloon and stent, said stent protector means being removed prior to use of the stent delivery system and release of the stent by expansion of the balloon, wherein the stent is crimped to the expandable member for delivery.

33. A stent delivery system comprising:

a catheter comprising a proximal portion, a distal portion, a shaft and an expandable member located at the distal portion, said expandable member having a first end and a second end and being constructed and arranged for expanding the outer diameter of said catheter from a contracted state to an expanded state;

a radially expandable stent of generally cylindrical configuration positioned around said distal portion of said catheter around the expandable member, said stent having a contracted condition, being sized in the contracted condition to closely surround the catheter in the contracted state, and further being expandable to an expanded condition;

removable stent protector means comprising a first removable sleeve in the region of the distal portion of the catheter positioned around the stent, said first sleeve further comprising a first end, and a second end, said first sleeve having a variable inner diameter to ease sliding the first sleeve over the balloon and stent, said stent protector means being removed prior to use of the stent delivery system and release of the stent by expansion of the balloon, wherein the first sleeve is made of a low friction material.

34. A stent delivery system comprising:

a catheter comprising a proximal portion, a distal portion, a shaft and an expandable member located at the distal portion, said expandable member having a first end and a second end and being constructed and arranged for expanding the outer diameter of said catheter from a contracted state to an expanded state;

a radially expandable stent of generally cylindrical configuration positioned around said distal portion of said catheter around the expandable member, said stent having a contracted condition, being sized in the contracted condition to closely surround the catheter in the contracted state, and further being expandable to an expanded condition;

removable stent protector means comprising a first removable sleeve in the region of the distal portion of the catheter positioned around the stent, said first sleeve further comprising a first end, and a second end said first sleeve having a variable inner diameter to ease sliding the first sleeve over the balloon and stent, said stent protector means being removed prior to use of the stent delivery system and release of the stent by expansion of the balloon, wherein the first end of the first sleeve further comprises a proximal flare.

35. A stent delivery system comprising:

a catheter comprising a proximal portion, a distal portion, a shaft and an expandable member located at the distal portion, said expandable member having a first end and a second end and being constructed and arranged for expanding the outer diameter of said catheter from a contracted state to an expanded state;

a radially expandable stent of generally cylindrical configuration positioned around said distal portion of said catheter around the expandable member, said stent having a contracted condition, being sized in the contracted condition to closely surround the catheter in the contracted state, and further being expandable to an expanded condition;

removable stent protector means comprising a first removable sleeve in the region of the distal portion of the catheter positioned around the stent, said first sleeve further comprising a first end, and a second end, said first sleeve having a variable inner diameter to ease sliding the first sleeve over the balloon and stent, said stent protector means being removed prior to use of the stent delivery system and release of the stent by expansion of the balloon, wherein said first sleeve has a slit extending therethrough, and wherein the slit is a spiral slit extending in a helical manner from the first end of the sleeve to the second end of the sleeve.