CA2711507A1 - Pleated deployment sheath - Google Patents

Pleated deployment sheath Download PDF

Info

Publication number
CA2711507A1
CA2711507A1 CA2711507A CA2711507A CA2711507A1 CA 2711507 A1 CA2711507 A1 CA 2711507A1 CA 2711507 A CA2711507 A CA 2711507A CA 2711507 A CA2711507 A CA 2711507A CA 2711507 A1 CA2711507 A1 CA 2711507A1
Authority
CA
Canada
Prior art keywords
sheath
medical device
delivery system
deployment
length
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
CA2711507A
Other languages
French (fr)
Other versions
CA2711507C (en
Inventor
Craig W. Irwin
James D. Silverman
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.)
Gore Enterprise Holdings Inc
Original Assignee
Gore Enterprise Holdings, Inc.
Craig W. Irwin
James D. Silverman
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 Gore Enterprise Holdings, Inc., Craig W. Irwin, James D. Silverman filed Critical Gore Enterprise Holdings, Inc.
Publication of CA2711507A1 publication Critical patent/CA2711507A1/en
Application granted granted Critical
Publication of CA2711507C publication Critical patent/CA2711507C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3468Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/97Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421Cannulas
    • A61B2017/3435Cannulas using everted sleeves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments 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
    • A61F2002/9665Instruments 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 with additional retaining means

Abstract

A deployment sheath (20) for medical devices (38) is provided that includes one or more pleats (34) in its pre-deployment state that are allowed to open during deployment so as to facilitate easier device deployment and sheath removal. Preferably, the sheath is removed by everting it over itself during the delivery process.
By orienting the pleats along the length of the sheath, preferably helically around the sheath, the sheath undergoes a predictable enlargement during deployment so as to relieve friction of the everted sheath sliding along itself during deployment. This allows the sheath to be removed with less tension than previous everting sheath constructions and assures more accurate device placement in a patient.

Claims (22)

1. A medical device delivery system comprising a tubular sheath, having a length, mounted about and containing a medical device;
wherein said tubular sheath includes at least one pleat oriented along at least a portion of the length.
2. The medical device delivery system of claim 1 wherein the pleat is oriented helically along at least a portion of the length of the sheath.
3. The medical device delivery system of claim 1 wherein the sheath includes means to assist in defining the pleat.
4. The medical device delivery system of claim 1 wherein a portion of the pleat is reinforced.
5. The medical device delivery system of claim 4 wherein the pleat is reinforced with a reinforcing material.
6. The medical device delivery system of claim 5 wherein the reinforcing material comprises a polymer strip attached to the sheath.
7. The medical device delivery system of claim 2 wherein at least a portion of the sheath is everted over itself prior to the medical device deployment.
8. The medical device delivery system of claim 7 wherein when tension is applied to the portion of the sheath that is everted, the everted portion of the sheath slides along the length of the device and the pleat progressively opens to provide an enlarged diameter to the everted portion of the sheath.
9. The medical device delivery system of claim 1 wherein the sheath comprises expanded polytetrafluoroethylene.
10. The medical device delivery system of claim 9 wherein the sheath comprises a tube of multiple layers of expanded polytetrafluoroethylene film.
11. The medical device delivery system of claim 1 wherein the medical device is an endoprosthesis.
12. The medical device delivery system of claim 11 wherein the endoprosthesis is a self-expanding device.
13. A medical device deployment system comprising a medical device having a length;
a sheath mounted around the medical device along at least a portion of its length, wherein prior to deployment the sheath is at least partially everted over itself to form an interior segment and an exterior segment;
wherein at least a portion of the interior segment of the sheath includes a helically oriented pleat.
14. The medical device deployment system of claim 13 wherein deployment occurs by applying tension to the exterior segment of the sheath to evert the interior segment and progressively reorient it into the exterior segment, with the pleat progressively opening as the sheath everts.
15. The medical device deployment system of claim 14 wherein the un-pleated exterior segment is of a sufficiently greater diameter than the pleated interior segment so as to reduce frictional contact between the interior segment and the exterior segment during deployment.
16. The medical device deployment system of claim 13 wherein a portion of the pleat is reinforced with a reinforcing material.
17. The medical device deployment system of claim 16 wherein the reinforcing material comprises a polymer strip attached to the sheath.
18. The medical device deployment system of claim 13 wherein the sheath comprises expanded polytetrafluoroethylene.
19. The medical device deployment system of claim 18 wherein the sheath comprises a tube of multiple layers of expanded polytetrafluoroethylene film.
20. The medical device delivery system of claim 13 wherein the medical device is an endoprosthesis.
21. The medical device delivery system of claim 20 wherein the endoprosthesis is a self-expanding device.
22. A delivery and deployment system for an endoprosthesis, comprising:
an endoprosthesis having a distal end, a proximal end, a first, smaller compacted diameter for insertion into a body conduit and a second, larger deployed diameter, said endoprosthesis provided at the first, smaller compacted diameter; and a constraining sheath wherein a first length portion of said sheath is fitted around the compacted endoprosthesis and extends along a length of the endoprosthesis and a second length portion that is everted back over the first length portion, wherein at least the first length portion of the constraining sheath includes a helically oriented fold.
CA2711507A 2008-01-15 2009-01-15 Pleated deployment sheath Active CA2711507C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US12/014,536 2008-01-15
US12/014,536 US8845712B2 (en) 2008-01-15 2008-01-15 Pleated deployment sheath
PCT/US2009/000321 WO2009091603A1 (en) 2008-01-15 2009-01-15 Pleated deployment sheath

Publications (2)

Publication Number Publication Date
CA2711507A1 true CA2711507A1 (en) 2009-07-23
CA2711507C CA2711507C (en) 2013-04-16

Family

ID=40592085

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2711507A Active CA2711507C (en) 2008-01-15 2009-01-15 Pleated deployment sheath

Country Status (8)

Country Link
US (2) US8845712B2 (en)
EP (1) EP2249749B1 (en)
JP (1) JP5710981B2 (en)
AU (1) AU2009205667B2 (en)
CA (1) CA2711507C (en)
ES (1) ES2581936T3 (en)
HK (1) HK1150530A1 (en)
WO (1) WO2009091603A1 (en)

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Also Published As

Publication number Publication date
AU2009205667A1 (en) 2009-07-23
JP5710981B2 (en) 2015-04-30
HK1150530A1 (en) 2012-01-06
US20130296877A1 (en) 2013-11-07
WO2009091603A1 (en) 2009-07-23
US20090182411A1 (en) 2009-07-16
CA2711507C (en) 2013-04-16
AU2009205667B2 (en) 2012-05-31
ES2581936T3 (en) 2016-09-08
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US8845712B2 (en) 2014-09-30
JP2011509744A (en) 2011-03-31

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