CA2482241A1 - Device for providing full protection to a stent - Google Patents

Device for providing full protection to a stent Download PDF

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Publication number
CA2482241A1
CA2482241A1 CA002482241A CA2482241A CA2482241A1 CA 2482241 A1 CA2482241 A1 CA 2482241A1 CA 002482241 A CA002482241 A CA 002482241A CA 2482241 A CA2482241 A CA 2482241A CA 2482241 A1 CA2482241 A1 CA 2482241A1
Authority
CA
Canada
Prior art keywords
sleeve
catheter
medical device
constructed
receiving region
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002482241A
Other languages
French (fr)
Other versions
CA2482241C (en
Inventor
Eric B. Stenzel
Ronald A. Sahatijian
Sheng-Ping Zhong
Kinh-Luan Dao
Peter L. Dayton
Daniel J. Kalashian
Thomas Yung-Hui Chien
Stephen Griffin
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Ltd Barbados
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2482241A1 publication Critical patent/CA2482241A1/en
Application granted granted Critical
Publication of CA2482241C publication Critical patent/CA2482241C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/97—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
    • A61F2002/9511—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A61F2002/9583—Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A61F2210/0023—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply

Abstract

A catheter (10) comprises a catheter shaft (18), at least a portion of which defines a medical device receiving region (22), and at least one sleeve (12, 14). The at least one sleeve comprises a tubular member (50, 51) 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 memb er are at least partially constructed from a shape memory material.

Claims (43)

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 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. 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
LA 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.
CA2482241A 2002-05-08 2003-04-14 Device for providing full protection to a stent Expired - Fee Related CA2482241C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/142,008 2002-05-08
US10/142,008 US6830575B2 (en) 2002-05-08 2002-05-08 Method and device for providing full protection to a stent
PCT/US2003/011636 WO2003094793A1 (en) 2002-05-08 2003-04-14 Device for providing full protection to a stent

Publications (2)

Publication Number Publication Date
CA2482241A1 true CA2482241A1 (en) 2003-11-20
CA2482241C CA2482241C (en) 2010-06-22

Family

ID=29399785

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2482241A Expired - Fee Related CA2482241C (en) 2002-05-08 2003-04-14 Device for providing full protection to a stent

Country Status (8)

Country Link
US (2) US6830575B2 (en)
EP (1) EP1501448B1 (en)
JP (1) JP4777646B2 (en)
AT (1) ATE418943T1 (en)
CA (1) CA2482241C (en)
DE (1) DE60325578D1 (en)
ES (1) ES2318128T3 (en)
WO (1) WO2003094793A1 (en)

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JP2005524487A (en) 2005-08-18
ES2318128T3 (en) 2009-05-01
US20030212410A1 (en) 2003-11-13
US20050096724A1 (en) 2005-05-05
EP1501448B1 (en) 2008-12-31
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US6830575B2 (en) 2004-12-14
JP4777646B2 (en) 2011-09-21
WO2003094793A1 (en) 2003-11-20
EP1501448A1 (en) 2005-02-02
US7691138B2 (en) 2010-04-06
ATE418943T1 (en) 2009-01-15

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