Method and device for providing full protection to a stent

• US 6,830,575 B2
• Filed: 05/08/2002
• Issued: 12/14/2004
• Est. Priority Date: 05/08/2002
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Sahatjian, Ronald A., Griffin, Stephen, Dayton, Peter L., Chien, Thomas Yung-hui, Stenzel, Eric B., Dao, Kinh-Luan D., Kalashian, Daniel J., Zhong, Sheng-ping
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US10/142,008
• Publication Number:
  US 20030212410A1
• Time in Patent Office: 951 Days
• Field of Search: 606/108, 606/194, 606/195, 606/198, 623/1.11, 623/1.12, 623/1.13
• 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 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 consisting of a first portion and a second portion being at least partially constructed from a shape memory material, 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, the second portion retracting away from the medical device receiving region by self-transitioning from the extended state to the retracted state of the tubular member.

2. The catheter of claim 1 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.

3. The catheter of claim 2 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.

4. The catheter of claim 2 wherein the expandable medical device is a balloon expandable stent.

5. The catheter of claim 4 wherein the medical device receiving region further defines a medical balloon.

6. The catheter of claim 1 wherein the catheter shaft defines a lumen, the lumen constructed and arranged to transmit a transition inducing element therethrough.

7. The catheter of claim 6 wherein the transition inducing element is selected from at least one member of the group consisting of:

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

8. The catheter of claim 1 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.

9. The catheter of claim 1 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.

10. The catheter of claim 1 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.

11. The catheter of claim 1 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.

12. The catheter 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.

13. The catheter of claim 12, 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.

14. The catheter of claim 12 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.

15. The catheter of claim 12 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.

16. The catheter of claim 12 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 end arranged 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 refracted 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.

17. The catheter of claim 16 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.

18. The catheter of claim 16 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.

19. The catheter of claim 1 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.

20. The catheter of claim 1 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.

21. The catheter of claim 16 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.

22. 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 consisting of 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 retracted state the second portion is removed from about the medical device receiving region, the first portion and the second portion of the tubular member being at least partially constructed from a shape memory material, the second portion comprising 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,

the catheter further comprising a 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 refracted state the at least one securement member being removed from about the at least two winged members.

23. 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 consisting of 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 retracted state the second portion is removed from about the medical device receiving region, the first portion and the second portion of the tubular member being at least partially constructed from a shape memory material, the second portion comprising 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,

the catheter 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 retracted 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 shave memory material,

the catheter still further comprising a protective casing, the protective casing being disposed about at least a portion of the first sheath portion.

24. The catheter of claim 23 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.

25. The catheter of claim 23 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.

26. The catheter of claim 25 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.

27. A catheter comprising:

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

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 consisting of 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, the second portion comprising 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 about the medical device receiving region; and

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.

28. The catheter of claim 27 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.