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

• US 6,416,529 B1
• Filed: 03/20/2000
• Issued: 07/09/2002
• Est. Priority Date: 03/05/1997
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Hanson, Scott M., Olson, Gregory K., Williams, Sonja J. K., Eidenschink, Tracee E. J., Holman, Thomas J., Ellis, Louis G., Traxler, Richard J., Lorentzen Cornelius, Linda R.
• Primary Examiner(s): Reip, David O.
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US09/528,613
• Time in Patent Office: 841 Days
• Field of Search: 606/194, 606/195, 606/198, 604/96.01, 604/103.05, 623/1.11, 623/1.12, 623/1.18, 623/1.19, 623/1.2
• US Class Current: 606/194
• 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 damns 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 medical device comprising:

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

protector means comprising a removable sleeve formed from a shape memory material, said sleeve being positioned around the expandable member, said sleeve comprising a first end and a second end and having a variable inner diameter by having a slit extending therethrough and from compressive forces generated by said shape memory material.

2. The medical device of claim 1 wherein the expandable member comprises a balloon and the distal portion further comprises at least one dam.

3. The medical device of claim 1 wherein the sleeve comprises a straight tube.

4. The medical device of claim 1 wherein the first end of the sleeve further comprises a proximal flare.

5. The medical device of claim 1 wherein the slit is a longitudinal slit extending from the first end of the sleeve to the second end of the sleeve.

6. A medical device comprising:

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

protector means comprising a removable sleeve positioned around the expandable member, said sleeve comprising a first end and a second end and having a variable inner diameter, said sleeve comprising a straight tube and wherein at least a portion of the sleeve is dimpled.

7. The medical device of claim 6 wherein the dimples are round-like.

8. The medical device of claim 6 wherein the dimples are helical grooves.

9. A medical device comprising:

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

protector means comprising a removable sleeve positioned around the expandable member, said sleeve comprising a first end and a second end and having a variable inner diameter, said sleeve comprising a straight tube and wherein the entire sleeve is dimpled.

10. A medical device comprising:

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

protector means comprising a removable sleeve positioned around the expandable member, said sleeve comprising a first end and a second end and having a variable inner diameter, said sleeve having a slit extending therethrough, 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 and said sleeve is formed from a shape memory material to provide said variable inner diameter.

11. A medical device comprising:

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

protector means comprising a removable sleeve positioned around the expandable member, said sleeve comprising a first end and a second end and having a variable inner diameter, said sleeve having a slit extending therethrough, 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.

12. The medical device of claim 11 wherein the distal continuous tubular portion further comprises a dimpled region and a substantially smooth region.

13. The medical device of claim 12 wherein the dimples are round-like.

14. The medical device of claim 12 wherein the dimples are helical grooves.

15. The medical device of claim 11 wherein the first end of the sleeve further comprises a proximal flare.

16. A medical device comprising:

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

removable protector means comprising;

a first removable inner sleeve positioned around the expandable member, said sleeve comprising a first end and a second end and having a variable inner diameter;

a second removable outer sleeve positioned over the first sleeve, said second sleeve having a first end and a second end,

said first and second sleeves being removed prior to use of the medical device.

17. The medical device of claim 16 wherein the expandable member and the first sleeve are of a material which resiliently deforms under radial pressure.

18. The medical device of claim 16 wherein the first sleeve and the second sleeve are made of a low friction material.

19. The medical device of claim 16 wherein at least one of said first and second sleeves is a straight or continuous tube.

20. A medical device comprising:

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

removable protector means comprising;

a first removable inner sleeve positioned around the expandable member, said sleve comprising a first end and a second end and having a variable inner diamete;

a second removable outer sleeve positioned over the first sleeve, said second sleeve having a first end and a second end,

said first and second sleeves being removed prior to use of the medical device, wherein said first sleeve is coextruded and has a high friction inner diameter and a low friction outer diameter, whereby the inner sleeve will not slip when the outer sleeve is pushed thereon.

21. A medical device comprising:

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

removable protector means comprising;

a first removable inner sleeve positioned around the expandable member, said sleeve comprising a first end and a second end and having a variable inner diameter;

a second removable outer sleeve positioned over the first sleeve, said second sleeve having a first end and a second end,

said first and second sleeves being removed prior to use of the medical device, wherein at least one of said first and second sleeves is a straight or continuous tube and wherein at least a protion of said atleast one continuous tube is dimpled.

22. The medical device of claim 21 wherein the continuous tube has round-like dimples.

23. The medical device of claim 21 wherein the continuous tube has helical grooved dimples.

24. The stent delivery system of claim 21 wherein the entire continuous tube is dimpled.

25. A medical device comprising:

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

removable protector means comprising;

a first removable inner sleeve positioned around the expandable member, said sleeve comprising a first end and a second end and having a variable inner diameter;

a second removable outer sleeve positioned over the first sleeve, said second sleeve having a first end and a second end,

said first and second sleeves being removed prior to use of the medical device, and wherein at least one of said and second sleeves has a slit extending therethrough.

26. The medical device of claim 25 wherein the slit is a longitudinal slit extending from the first end of the sleeve to the second end of the sleeve.

27. The medical device of claim 25 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.

28. The medical device of claim 25 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 medical device comprising:

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

removable protector means comprising;

a first removable inner sleeve positioned around the expandable member, said sleeve comprising a first end and a second end and having a variable inner diameter;

a second removable outer sleeve positioned over the first sleeve, said second sleeve having a first end and a second end,

said first and second sleeves being removed prior to use of the medical device, and wherein the distal portion of the cather further comprises at least one enlarged portion, whereby when compressed by the outer sleeve, the inner sleeve will have an inner diameter less than or equal to the outer diameter of the at least one enlarged portion.

33. The medical device of claim 32 wherein the at least one enlarged portion comprises a proximal dam and a distal dam spaced a predetermined distance apart, said dams having an equal outer diameter, and the expandable member comprises a balloon located over and between said dams.