CA2593365C - Rolling membrane with hydraulic recapture means for self expanding stent - Google Patents

Rolling membrane with hydraulic recapture means for self expanding stent Download PDF

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Publication number
CA2593365C
CA2593365C CA2593365A CA2593365A CA2593365C CA 2593365 C CA2593365 C CA 2593365C CA 2593365 A CA2593365 A CA 2593365A CA 2593365 A CA2593365 A CA 2593365A CA 2593365 C CA2593365 C CA 2593365C
Authority
CA
Canada
Prior art keywords
outer sheath
stent
medical device
proximal
rolling membrane
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.)
Expired - Fee Related
Application number
CA2593365A
Other languages
French (fr)
Other versions
CA2593365A1 (en
Inventor
Andrzej Malewicz
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
Boston Scientific Ltd Barbados
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 Boston Scientific Ltd Barbados filed Critical Boston Scientific Ltd Barbados
Publication of CA2593365A1 publication Critical patent/CA2593365A1/en
Application granted granted Critical
Publication of CA2593365C publication Critical patent/CA2593365C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2/9661—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod the proximal portion of the stent or stent-graft is released first
    • 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
    • A61F2002/9528—Instruments specially adapted for placement or removal of stents or stent-grafts for retrieval of stents
    • 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
    • A61F2002/9534—Instruments specially adapted for placement or removal of stents or stent-grafts for repositioning of stents

Abstract

A medical device comprising (10) a catheter having a retractable outer sheath (20) and a rolling membrane (36). The catheter includes a catheter inner shaft (24) about which a stent (22) in a reduced diameter configuration may be disposed. A stent retaining region of the sheath is disposed about the stent to retain the stent in the reduced diameter state prior to delivery. The rolling membrane is positioned between the catheter inner shaft and the outer sheath and prior to retraction of the sheath the rolling membrane is disposed about at least a proximal section of the stent and is rollingly retracted therefrom when the sheath is retracted to deliver the stent. The device also recaptures a stent by pressurizing a intra-catheter space, which results in the longitudinal movement of the outer sheath in a distal direction to revocer and retain the stent.

Claims (31)

1. A medical device comprising:
a catheter, the catheter having a distal portion and a proximal portion and comprising:
an inner shaft, the inner shaft having a distal portion and a proximal portion, wherein a portion of the distal portion of the inner shaft defines a stent receiving region for receiving a stent that is expandable from a reduced state to an expanded state;
a distal outer sheath, the distal outer sheath being about the inner shaft and being longitudinally movable relative thereto between an extended position, which is at least partially about the receiving region, and a retracted position;
a rolling membrane having a first end and a second end, the first end being sealingly engaged with the distal outer sheath and the second end being sealingly engaged with the inner shaft; and an intra-catheter space, the intra-catheter space being defined by, at least in part, the rolling membrane and the distal outer sheath;
wherein, when the distal outer sheath is proximally retracted, the distal outer sheath and the rolling membrane rolls back from the stent mounted on the stent receiving region; and wherein, when the intra-catheter space is pressurized with the rolling membrane covering a part of the stent, the distal outer sheath moves distally relative to the inner shaft such that the rolling membrane captures the stent.
2. The medical device of claim 1, a portion of the distal outer sheath defining a stent retaining region at the distal portion of the catheter, the stent retaining region being disposed about the inner shaft and being longitudinally moveable relative thereto, the stent retaining region being moveable between the extended position and the retracted position, which is proximal to the extended position, wherein, when the distal outer sheath is in the extended position, the retaining region is disposed about the stent receiving region and, when it is in the retracted position, the distal outer sheath is proximally removed from the stent receiving region.
3. The medical device of claim 2, wherein, when the distal outer sheath is in its extended position, the engagement between the rolling membrane and the distal outer sheath is distally positioned relative to the engagement between the rolling membrane and the inner shaft and the rolling membrane is positioned between the inner shaft and the distal outer sheath, and wherein, when the distal outer sheath is in its retracted position, the engagement between the rolling membrane and the distal outer sheath is proximally positioned relative to the engagement between the rolling membrane and the inner shaft.
4. The medical device of claim 3, further comprising a proximal outer sheath, the proximal outer sheath being disposed about the inner shaft and being sealingly engaged therewith, wherein the proximal outer sheath is positioned proximal to the stent receiving region and is sealingly engaged with the distal outer sheath.
5. The medical device of claim 4, the intra-catheter space being further defined by the inner shaft and the proximal outer sheath.
6. The medical device of claim 5, further comprising a pressure port, the pressure port being in communication with the intra-catheter space, wherein, when the distal outer sheath is in its retracted position, introduction of fluid through the pressure port into the intra-catheter space causes the distal outer sheath to longitudinally move toward its extended position.
7. The medical device of claim 6, wherein the stent has a diameter in its reduced state that is less than the diameter in the expanded state, wherein, when the distal outer sheath is in the extended position, the stent is in the reduced state, disposed about the stent receiving region and wherein the stent has a proximal edge, a distal edge and a length measured from between the proximal edge and distal edge.
8. The medical device of claim 7, wherein, when the distal outer sheath is in the extended position, a portion of the rolling membrane is disposed about at least a proximal section of the stent.
9. The medical device of claim 8, the at least a proximal section of the stent defining about a half of the length of the stent as measured from the proximal edge.
10. The medical device of claim 8, the at least a proximal section of the stent defining about a 50 percent to about 100 percent of the length of the stent as measured from the proximal edge.
11. The medical device of claim 7, wherein the rolling membrane is defined by a single layer.
12. The medical device of claim 11, wherein the second end of the rolling membrane is engaged to the inner shaft at a point proximately positioned relative to the proximal edge of the stent.
13. The medical device of claim 7, wherein the pressure port is located in the proximal outer sheath.
14. The medical device of claim 12, wherein the second end of the rolling membrane is sealingly attached to a raised hub on the inner shaft.
15. The medical device of claim 7, wherein the first end of the rolling membrane is sealing attached to the distal end of the stent retaining region of the distal outer sheath.
16. The medical device of claim 7, wherein a distal portion of the proximal outer sheath and a proximal portion of the distal outer sheath overlap and are sealing engaged with one another via a sliding seal, the sliding seal maintaining a fluid seal between the proximal outer sheath and the distal outer sheath during longitudinal movement of the distal outer sheath relative to the proximal outer sheath and the inner shaft.
17. The medical device of claim 16, wherein the proximal outer sheath is sealingly attached to a raised hub on the inner shaft.
18. The medical device of claim 7, wherein at least a portion of the rolling
19 membrane includes a lubricious coating applied thereto.

19. The medical device of claim 18, wherein the rolling membrane has an inner surface and an outer surface, the lubricious coating being applied to at least a portion of at least one of the inner surface and outer surface of the rolling membrane.
20. The medical device of claim 7, further comprising a stent securing hub, the stent securing hub being engaged to the inner shaft and being positioned immediately proximal of the stent receiving region.
21. The medical device of claim 20, wherein the rolling membrane is sealingly connected to the stent securing hub.
22. The medical device of claim 21, wherein the stent securing hub is at least partially radiopaque.
23. The medical device of claim 22, wherein the stent securing member is configured to be detectable by at least one of the following detection modalities: X-Ray, MRI, ultrasound, and any combination thereof.
24. The medical device of claim 7, wherein the distal outer sheath is at least partially constructed of at least one material of the group consisting of:
polyurethane, polytetrafluoroethylene, high density polyethylene, polyamide, polyimide, and any combinations thereof.
25. The medical device of claim 7, wherein the rolling membrane is at least partially constructed of at least one material of the group consisting of polyester, polyamide, polyethylene terephalate, crosslinked polyethylene, polyurethane, polyvinylchloride, polytetrafluoroethylene, nylon, polyether block amides, silicone, POC, polyether, and any combinations thereof.
26. The medical device of claim 7, wherein the stent is configured to be detectable by at least one of the following detection modalities: X-Ray, MRI, ultrasound, and any combination thereof.
27. The medical device of claim 7, wherein at least a portion of the stent comprises at least one therapeutic agent.
28. The medical device of claim 1, wherein the catheter is a fixed-wire catheter.
29. The medical device of claim 1, wherein the inner shaft defines a guidewire lumen for passage of a guidewire therethrough.
30. The medical device of claim 1, wherein the distal outer sheath is welded to the rolling membrane.
31. The medical device of claim 1, wherein the distal outer sheath is bonded to the rolling membrane with an adhesive.
CA2593365A 2005-03-03 2005-12-20 Rolling membrane with hydraulic recapture means for self expanding stent Expired - Fee Related CA2593365C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US11/071,644 US7632296B2 (en) 2005-03-03 2005-03-03 Rolling membrane with hydraulic recapture means for self expanding stent
US11/071,644 2005-03-03
PCT/US2005/046792 WO2006096229A1 (en) 2005-03-03 2005-12-20 Rolling membrane with hydraulic recapture means for self expanding stent

Publications (2)

Publication Number Publication Date
CA2593365A1 CA2593365A1 (en) 2006-09-14
CA2593365C true CA2593365C (en) 2012-09-04

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2593365A Expired - Fee Related CA2593365C (en) 2005-03-03 2005-12-20 Rolling membrane with hydraulic recapture means for self expanding stent

Country Status (7)

Country Link
US (2) US7632296B2 (en)
EP (1) EP1861040B1 (en)
JP (1) JP4974906B2 (en)
AT (1) ATE494864T1 (en)
CA (1) CA2593365C (en)
DE (1) DE602005025939D1 (en)
WO (1) WO2006096229A1 (en)

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US8066754B2 (en) 2011-11-29
US7632296B2 (en) 2009-12-15
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CA2593365A1 (en) 2006-09-14

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