Method and device for providing full protection to a stent

• US 20050096724A1
• Filed: 12/14/2004
• Published: 05/05/2005
• Est. Priority Date: 05/08/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Sahatjian, Ronald A., Dayton, Peter L., Dao, Kinh-Luan D., Kalashian, Daniel J., Zhong, Sheng-ping, Griffin, Stephen, Chien, Thomas Yung-hui, Stenzel, Eric B.
• Granted Patent: US 7,691,138 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• 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 second portion being at least partially constructed from a shape memory material and 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, 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 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 1 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 1 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.

18-43. -43. (canceled)

44. 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 exerting a preloaded elastic proximal force on the second portion, in the extended state the second portion extending into the medical device receiving region and secured in place by securement members which break when a retraction trigger is activated, in the retracted state the second portion retracted from the medical device receiving region.

45. The catheter of claim 44 wherein the securement members are frangible strands.

46. The catheter of claim 44 wherein the retraction trigger is sufficient inflation of a balloon disposed about the catheter shaft to break the securement members.

47. The catheter of claim 44 wherein wing members on the distal end of the catheter shaft further secure the second portion of the sleeve when in the extended state, the wing members overlaying at least a portion of the second portion of the sleeve.

48. The catheter of claim 44 wherein the first portion comprises a multiplicity of elastic strands.