CA2451665A1 - Implant having improved fixation to a body lumen and method for implanting the same - Google Patents

Implant having improved fixation to a body lumen and method for implanting the same Download PDF

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Publication number
CA2451665A1
CA2451665A1 CA002451665A CA2451665A CA2451665A1 CA 2451665 A1 CA2451665 A1 CA 2451665A1 CA 002451665 A CA002451665 A CA 002451665A CA 2451665 A CA2451665 A CA 2451665A CA 2451665 A1 CA2451665 A1 CA 2451665A1
Authority
CA
Canada
Prior art keywords
prosthetic component
graft
hem
body lumen
cord
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
CA002451665A
Other languages
French (fr)
Other versions
CA2451665C (en
Inventor
Paul Dicarlo
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 Bermuda
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 CA2451665A1 publication Critical patent/CA2451665A1/en
Application granted granted Critical
Publication of CA2451665C publication Critical patent/CA2451665C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • A61F2002/075Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/0054V-shaped

Abstract

A device for improving fixation and sealing of a prosthetic component when implanted in a body lumen during laparoscopic, endovascular, or open surgical procedures. In one embodiment, the prosthetic component comprises a graft having a hem defining an interior space. Enclosed within the space is an absorbent cord. The cord expands as it comes in contact with body fluids. The expansion due to the absorbed fluids forms a seal closely following the irregular shape of the lumen and improves fixation at the junction of the body lumen and the prosthetic component. Hem and cord arrangement also used to improve fixation of one prosthetic component to another in a modular graft. In another embodiment, an attachment tab has one part affixed to the outer periphery of the graft and another part attached to an area adjacent to the body lumen upon implantation, to resist forces tending to move the implant.

Claims (34)

1. A device for implantation in a body lumen comprising:
a prosthetic component comprising a graft having a hem formed on said graft, wherein said hem defines an interior space; and a cord disposed within said interior space for expanding upon absorbing fluid for aiding in fixating said prosthetic component against said body lumen.
2. The device of claim 1, wherein said prosthetic component further comprises a stent disposed radially inside of said graft.
3. The device of claim 1, wherein said hem is disposed at a distal end of said prosthetic component.
4. The device of claim 3, wherein said graft further comprises a second hem disposed at a proximal end of said prosthetic component and defining a second interior space and said device further comprises a second cord disposed within said second interior space.
5. The device of claim 3, wherein said cord is in a compressed state prior to being contacted with fluid.
6. The device of claim 5, wherein the thickness of said cord in the Compressed state is less than thirty thousandths of an inch.
7. The device of claim 1, wherein said cord has a flat ribbon shape.
8. The device of claim 1, wherein said cord has a shape selected from the group consisting of annular, circular, semi-circular, D-shaped, rectangular, octagonal, trapezoidal, triangular, and square.
9. The device of claim 1 further comprising an outer coating formed over said cord, wherein said coating dissolves upon exposure to fluid for varying the rate at which said cord expands after deployment of said device.
10. The device of claim 1, wherein said hem has holes to adjust the porosity of said hem for allowing fluid to contact said cord.
11. The device of claim 1, wherein said hem is sufficiently ductile to conform to irregular shapes.
12. The device of claim 2, wherein said hem is positioned to allow said stent to protrude distally relative to said hem.
13. The device of claim 12, wherein at least one hoop of said stent is distal relative to said hem.
14. The device of claim 1, wherein said graft has a first permeability at areas remote from said hem and a second permeability, greater than said first permeability, at said hem.
15. The device of claim 1 further comprising an attachment tab having a first part attached to the graft and a second part extending radially outward of said first part for attachment to an adjacent area of the body surrounding the prosthetic component.
16. A device for implantation in a body lumen comprising:
a prosthetic component comprising a graft having an outer periphery; and at least one attachment tab having a first part attached to the outer periphery and a second part extending radially outward of said first part for attachment to an adjacent area of the body surrounding the prosthetic component.
17. The device of claim 16, wherein said attachment tab is a polyester, polytetrafluorethylene or bio-absorbable material.
18. The device of claim 16 further comprising a wire to connect said attachment tab to said graft.
19. The device of claim 16, wherein said prosthetic component further comprises a self expanding stent disposed radially inside of said graft.
20. The device of claim 16, wherein said prosthetic component further comprises a balloon expandable stent disposed radially inside of said graft.
21. The device of claim 16, wherein said at least one attachment tab comprises a plurality of attachment tabs and said device further comprises at least one tab extension ring positioned along the outer periphery of the graft to attach to the tabs for radially extending the tabs to contact the adjacent area of the body.
22. The device of claim 16, wherein said attachment tab is square.
23. The device of claim 16, wherein said attachment tab is chevron.
24. The device of claim 16, wherein said attachment tab is an integral part of said graft.
25. A method for implanting a device in a body lumen comprising the steps of:
introducing a device into a body lumen, wherein said device comprises: a prosthetic component comprising a graft having a hem formed on said graft, wherein said hem defines an interior space; and a cord disposed within said interior space for expanding upon absorbing fluid; and contacting said cord with fluid to aid in fixating said prosthetic component against said body lumen.
26. The method of claim 25, wherein introducing said device comprises the following steps:
compressing the device into an introduces;
inserting the introduces into the body lumen;
positioning the introduces such that the compressed prosthetic component is at a predetermined location within the body lumen; and withdrawing the introducer to expand the prosthetic component to its decompressed size at the predetermined location within the body lumen.
27. The method of claim 25, wherein contacting said cord with fluid comprises the following steps:
aligning the outside circumference of the hem within the inside diameter of the body lumen; and removing an impediment to the flow of fluid within the body lumen to said cord.
28. A method for implanting a device in a body lumen comprising the steps of:
introducing a device into a body lumen, wherein said device comprises a prosthetic component comprising a graft having an outer periphery and at least one attachment tab having a first part attached to the outer periphery and a second part extending radially outward of said first part; and attaching said second part of said attachment tab to an adjacent area of the body surrounding the prosthetic component.
29. The method of claim 28, wherein the attaching step comprises suturing said second part of said attachment tab to the adjacent area of the body.
30. The method of claim 28, wherein said device further comprises a wire for attaching said attachment tab to the outer periphery and the attaching step comprises suturing said second part of said attachment tab to the adjacent area of the body surrounding the prosthetic component after the wire expands due to contact with a fluid.
31. The method of claim 20, wherein the attaching step comprises the following steps:
sliding a tab extension ring having a spur axially along the outer periphery of the prosthetic component; and engaging said spur of said tab extension ring into a proximal end pouch of said attachment tab for radially extending said attachment tab.
32. A device for implantation in a body lumen comprising:
a prosthetic component comprising a graft having a hem formed on said graft, wherein said hem defines an interior space;
a stent disposed radially inside of said graft;
a cord disposed within said interior space for expanding upon absorbing fluid for aiding in fixating said prosthetic component against said body lumen;
at least one attachment tab having a first part attached to the outer periphery of said graft and a second part configured for extending radially outward of said first part for attachment to an adjacent area of the body surrounding the implantation of the prosthetic component; and at least one tab extension ring configured as part of the stent along the outer periphery of the graft and attach to at least one tab for radially extending the tab to contact the adjacent area of the body.
33. A device for implantation in a body lumen comprising:
a first prosthetic component comprising a first graft;
a second prosthetic component comprising a second graft having a first hem, wherein said first hem defines an interior space and a portion of said second prosthetic component is adapted to be disposed within said first prosthetic component such that said first hem contacts the interior wall of said first prosthetic component; and a cord disposed within said interior space for expanding upon absorbing fluid for aiding in fixating said second prosthetic component against said first prosthetic component.
34. The device of claim 33, wherein said second prosthetic component further comprises a second hem radially disposed around said second prosthetic component proximal to the proximal end of said first prosthetic component for resisting movement of said second prosthetic component in the distal direction.
CA2451665A 2001-07-03 2002-06-26 Implant having improved fixation to a body lumen and method for implanting the same Expired - Fee Related CA2451665C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/898,936 US6994722B2 (en) 2001-07-03 2001-07-03 Implant having improved fixation to a body lumen and method for implanting the same
US09/898,936 2001-07-03
PCT/US2002/020259 WO2003003945A2 (en) 2001-07-03 2002-06-26 Implant having means for fixation to a body lumen and method for implanting the same

Publications (2)

Publication Number Publication Date
CA2451665A1 true CA2451665A1 (en) 2003-01-16
CA2451665C CA2451665C (en) 2010-02-23

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2451665A Expired - Fee Related CA2451665C (en) 2001-07-03 2002-06-26 Implant having improved fixation to a body lumen and method for implanting the same

Country Status (9)

Country Link
US (1) US6994722B2 (en)
EP (1) EP1401357B1 (en)
JP (1) JP4384909B2 (en)
AT (1) ATE358459T1 (en)
AU (1) AU2002315457A1 (en)
CA (1) CA2451665C (en)
DE (1) DE60219313T2 (en)
ES (1) ES2284881T3 (en)
WO (1) WO2003003945A2 (en)

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CA2451665C (en) 2010-02-23
EP1401357B1 (en) 2007-04-04
WO2003003945A3 (en) 2003-06-19
JP4384909B2 (en) 2009-12-16
US6994722B2 (en) 2006-02-07
US20030009211A1 (en) 2003-01-09
ATE358459T1 (en) 2007-04-15
EP1401357A2 (en) 2004-03-31
DE60219313T2 (en) 2008-01-03
JP2004531356A (en) 2004-10-14
AU2002315457A1 (en) 2003-01-21
WO2003003945A2 (en) 2003-01-16
DE60219313D1 (en) 2007-05-16
ES2284881T3 (en) 2007-11-16

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