Method and device for providing full protection to a stent

• US 20030212410A1
• Filed: 05/08/2002
• Published: 11/13/2003
• Est. Priority Date: 05/08/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Kalashian, Daniel J., Sahatjian, Ronald A., Griffin, Stephen, Chien, Thomas Yung-Hui, Zhong, Sheng-Ping, Dayton, Peter L., Stenzel, Eric B., Dao, Kinh-Luan D.
• Granted Patent: US 6,830,575 B2
• Time in Patent Office: Days
• US Class Current: 606/108
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• 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: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0023 operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply

Abstract

A catheter comprises a catheter shaft, at least a portion of which defines a medical device receiving region, and at least one sleeve. The at least one sleeve comprises a tubular member constructed and arranged to transition between an extended state and a retracted state. The tubular member has a first portion being engaged to a portion of the catheter shaft adjacent to the medical device receiving region. In the extended state a second portion is constructed and arranged to at least partially overlay the medical device receiving region. In the retraced state the second portion is removed from about the medical device receiving region. At least one of the first portion and the second portion of the tubular member are at least partially constructed from a shape memory material.

Claims

1. A retractable sleeve for use with a catheter, the sleeve comprising:

a tubular member constructed and arranged to transition between an extended state and a retracted state, the tubular member further having a first portion and a second portion, the first portion is constructed and arranged to be engaged to at least a portion of a catheter shaft and in the extended state the second portion constructed and arranged to at least partially overlay a medical device receiving region of the catheter shaft, in the retraced state the second portion being removed from about the medical device receiving region, at least one of the first portion and the second portion of the tubular member being at least partially constructed from a shape memory material.

2. The sleeve of claim 1 wherein at least one of the first portion and the second portion of the tubular member are at least partially constructed from a non-shape memory material.

3. The sleeve of claim 1 wherein at least one portion of the tubular member is comprised of at least one strand of sleeve material.

4. The sleeve of claim 3 wherein at least one of the strands is made from a shape memory material.

5. The sleeve of claim 3 wherein at least one of the strands is made from a non-shape memory material.

6. The sleeve of claim 1 wherein in the retracted state the second portion is constructed and arranged to be longitudinally retracted from the medical device receiving region.

7. The sleeve of claim 1 wherein in the retracted state the second portion is constructed and arranged to be rollingly retracted from the medical device receiving region.

8. The sleeve of claim 1 wherein in the retracted state the second portion is constructed and arranged to radially expand off of the medical device receiving region.

9. The sleeve of claim 1 wherein in the extended state, the second portion is constructed and arrange to extend over the entire medical device receiving region of the catheter.

10. The sleeve of claim 1 wherein the second portion comprises at least two winged members, the at least two winged members extending from the first portion, in the extended state the at least two winged members constructed and arranged to at least partially overlay the medical device receiving region of the catheter shaft, in the retracted state the at least two winged members being removed from the medical device receiving region.

11. The sleeve of claim 10 wherein the at least two winged members in the extended state are constructed and arranged to provide sufficient radial strength to retain a medical device in an unexpanded state about the medical device receiving region.

12. The sleeve of claim 10 further comprising at least one securement member, in the extended state the at least one securement member is disposed about the at least two winged members and being constructed and arranged to secure at least a portion of each of the at least two winged members over at least a portion of the medical device receiving region, in the retracted state the at least one securement member being removed from about the at least two winged members.

13. The sleeve of claim 12 further comprising a covering layer, the covering layer overlaying at least a portion of the at least one securement member and the at least two winged members.

14. The sleeve of claim 12 further comprising a covering layer, the covering layer overlaying at least a portion of the at least one securement member and the tubular member.

15. The sleeve of claim 1 wherein, the shape memory material is selected from at least one member of the group consisting of:

shape memory metal;

natural rubber;

shape memory polymers and any combination thereof.

16. The sleeve of claim I wherein the transition between the extended state and the retracted state is achieved by exposing the tubular member to at least one transition condition.

17. The sleeve of claim I wherein the transition condition is selected from at least one member of the group consisting of:

a predetermined temperature, predetermined pH, predetermined light energy, predetermined mechanical stimulation, predetermined electrical stimulation, and any combination thereof.

18. A catheter comprising:

a catheter shaft, at least a portion of the catheter shaft defining a medical device receiving region; and

at least one sleeve, the at least one sleeve comprising a tubular member constructed and arranged to transition between an extended state and a retracted state, the tubular member further having a first portion and a second portion, the first portion being engaged to a portion of the catheter shaft adjacent to the medical device receiving region, in the extended state the second portion at least partially overlays the medical device receiving region of the catheter shaft, in the retraced state the second portion is removed from about the medical device receiving region, at least one of the first portion and the second portion of the tubular member being at least partially constructed from a shape memory material.

19. The catheter of claim 18 further comprising an expandable medical device, in the extended state the expandable medical device being disposed about at least a portion of the medical device receiving region, and being at least partially overlaid by the second portion of the at least one sleeve.

20. The catheter of claim 19 wherein the expandable medical device is a self-expanding stent, in the extended state, the self expanding stent being retained in a reduced state by the at least one sleeve.

21. The catheter of claim 19 wherein the expandable medical device is a balloon expandable stent.

22. The catheter of claim 21 wherein the medical device receiving region further defines a medical balloon.

23. The catheter of claim 18 wherein the catheter shaft defines a lumen, the lumen constructed and arranged to transmit a transition inducing element therethrough.

24. The catheter of claim 23 wherein the transition inducing element is selected from at least one member of the group consisting of:

a fiber optic line, a heating element, an electrically resistive wire, an electrically conductive wire, an IR heat source, an ultrasonic heat source, a bolus of heated saline solution, a bolus of saline solution having a predetermined pH, and any combination thereof.

25. The catheter of claim 18 wherein in the retracted state the second portion of the at least one sleeve is constructed and arranged to be longitudinally retracted from the medical device receiving region.

26. The catheter of claim 18 wherein in the retracted state the second portion of the at least one sleeve is constructed and arranged to be rollingly retracted from the medical device receiving region.

27. The catheter of claim 18 wherein in the retracted state the second portion of the at least one sleeve is constructed and arranged to radially expand off of the medical device receiving region.

28. The catheter of claim 18 wherein in the extended state, the second portion of the at least one sleeve is constructed and arranged to extend over the entire medical device receiving region of the catheter.

29. The catheter of claim 18 wherein the second portion comprises at least two winged members, the at least two winged members extending from the first portion, in the extended state the at least two winged members constructed and arranged to at least partially overlay the medical device receiving region of the catheter shaft, in the retracted state the at least two winged members being removed from the medical device receiving region.

30. The catheter of claim 29, the at least two winged members in the extended state are constructed and arranged to provide sufficient radial strength to retain a medical device in a reduced state about the medical device receiving region.

31. The catheter of claim 29 wherein further comprising at least one securement member, in the extended state the at least one securement member is disposed about the at least two winged members and is constructed and arranged to secure at least a portion of each of the at least two winged members over at least a portion of the medical device receiving region, in the retracted state the at least one securement member being removed from about the at least two winged members.

32. The catheter of claim 29 further comprising at least one covering layer, the at least one covering layer overlaying at least a portion of the at least one securement member and the at least two winged members.

33. The catheter of claim 29 further comprising at least one covering layer, the at least one covering layer overlaying at least a portion of the at least one securement member and the tubular member.

34. The catheter of claim 29 further comprising a retractable body sheath, the retractable body sheath comprising a first sheath portion and a second sheath portion, the retractable body sheath constructed and arranged to transition between the extended state and the retracted state, the first sheath portion being engaged to an engagement portion of the catheter shaft adjacent to the medical device receiving region, in the extended state the second sheath portion constructed and arranged to overlay the medical device receiving region of the catheter shaft, in the retraced state the second sheath portion being longitudinally retracted from about the medical device receiving region, at least the first portion of the retractable body sheath being at least partially constructed from a shape memory material.

35. The catheter of claim 34 wherein in the extended state, the winged members of the at least one sleeve are removably engaged to at least a portion of the second sheath portion.

36. The catheter of claim 34 wherein in the retracted state, the winged members of the at least one sleeve release the at least a portion of the second sheath portion.

37. The catheter of claim 34 further comprising a protective casing, the protective casing being disposed about at least a portion of the first sheath portion.

38. The catheter of claim 37 wherein in the retracted state the protective casing is constructed and arranged to receivingly engage the first sheath portion and at least a portion of the second sheath portion.

39. The catheter of claim 37 further comprising a winged sleeve member, the winged sleeve member comprising a first sleeve portion engaged to at least a portion of the protective casing, and a second sleeve portion having two winged sleeve members, in the extended state the two winged sleeve members are removably engaged to at least a portion of the second sheath portion.

40. The catheter of claim 18 wherein the at least one sleeve is at least partially constructed from at least one member of the group consisting of:

shape memory metal, natural rubber, shape memory polymer, and any combination thereof.

41. The catheter of claim 18 wherein the at least one sleeve is at least partially constructed from at least one member of the group consisting of:

shape memory metal;

natural rubber;

shape memory polyurethanes;

crosslinked trans-polyoctylene rubber;

polynorbornene polymers and copolymers;

blends of polynorbornene polymers and copolymers with styrene elastomer copolymers and polyethylene;

styrene butadiene copolymers;

PMMA;

polyurethane;

cross-linked polyethylene;

cross-linked polyisoprene;

polycycloocetene;

polycaprolactone and copolymers of (oligo)caprolactone;

PLLA and PL/D L A copolymers;

PLLA PGA copolymers;

Azo-dyes;

photo chromatic materials; and

any combination thereof.

42. The catheter of claim 34 wherein the retractable body sheath is at least partially constructed from at least one member of the group consisting of:

shape memory metal, natural rubber, shape memory polymer, and any combination thereof.

43. The catheter of claim 39 wherein the winged sleeve member is at least partially constructed from at least one member of the group consisting of:

shape memory metal, natural rubber, shape memory polymer, and any combination thereof.