CA2609933A1 - Percutaneous catheter directed intravascular occlusion devices - Google Patents

Percutaneous catheter directed intravascular occlusion devices Download PDF

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Publication number
CA2609933A1
CA2609933A1 CA 2609933 CA2609933A CA2609933A1 CA 2609933 A1 CA2609933 A1 CA 2609933A1 CA 2609933 CA2609933 CA 2609933 CA 2609933 A CA2609933 A CA 2609933A CA 2609933 A1 CA2609933 A1 CA 2609933A1
Authority
CA
Canada
Prior art keywords
medical device
disk
strands
diameter
recited
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
CA 2609933
Other languages
French (fr)
Other versions
CA2609933C (en
Inventor
Kurt Amplatz
Xiaoping Gu
John C. Oslund
Daniel O. Adams
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.)
St Jude Medical Cardiology Division Inc
Original Assignee
AGA Medical Corp
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=38879277&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2609933(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by AGA Medical Corp filed Critical AGA Medical Corp
Publication of CA2609933A1 publication Critical patent/CA2609933A1/en
Application granted granted Critical
Publication of CA2609933C publication Critical patent/CA2609933C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/08Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12177Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00592Elastic or resilient implements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00606Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00628T-shaped occluders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00632Occluding a cavity, i.e. closing a blind opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect

Abstract

The present invention provides an improved vascular occlusion device having improved flexibility and retention of the type fabricated from braided tubular metal fabric having an expanded preset configuration and an elongated collapsed reduced diameter configuration for delivery through a catheter to a treatment site and shaped to create an occlusion of an abnormal opening in a body organ or vessel, the woven metal fabric having a memory property whereby the medical device tends to return to said expanded preset configuration when unconstrained. The device further including at least one disk portion adjacent a body cylindrical portion formed from the fabric and having a transition diameter between the disk and cylindrical portion, significantly smaller than the diameter of the disk and the diameter of the cylindrical portion.

Claims (21)

1. A collapsible medical device, comprising a plurality of metal strands woven into a tubular woven metal fabric having a proximal end and a distal end, each end having a means for securing each end attached to said tubular woven metal fabric, thereby gathering said strands and inhibiting unraveling of the strands, said tubular woven metal fabric having an expanded preset configuration shaped to create an occlusion of an abnormal opening in a body organ, said expanded preset configuration having a disk shape portion of a first diameter on at least one of the proximal and distal ends and an adjacent cylindrical shaped portion of a second diameter, the disk and cylindrical portions being connected by a transition segment whose diameter is smaller than both the first and second diameters and the device being deformable to a lesser cross-sectional dimension for delivery through a channel in a patient's body, the woven metal fabric having a memory property whereby the medical device tends to return to said expanded preset configuration when unconstrained.
2. The medical device as recited in claim 1, wherein said means for securing each end has a threaded bore for rotational attachment to a delivery device.
3. The medical device as recited in claim 2, optionally including an occluding fiber retained within at least one of the disk-shaped portion and the cylindrical shaped portion formed in said tubular woven fabric.
4. The medical device as recited in claim 1, wherein the metal strands comprise an alloy selected from the group consisting of stainless steel, nickel-titanium, and cobalt-chromium-nickel.
5. The medical device as recited in claim 4, further including an occluding fiber retained within at least one of the disk-shaped portion and the cylindrical-shaped portion.
6. The medical device as recited in claim 1, further including an occluding fiber retained within at least one of the disk-shaped portion and the cylindrical-shaped portion.
7. The medical device of claim 1 where an end of the cylindrical portion has a concave tapered surface.
8. The medical device as recited in claim 7 and further including an occluding fiber retained within a hollow portion of said tubular woven fabric.
9. The medical device as in claim 1 wherein the medical device has the dimensions as identified in Figure 5A of the drawings hereof and quantified in Table I
of the specification.
10. The medical device of claim 1 wherein the metal strands have a diameter in a range of from 0.002 to 0.005 inch and the woven metal fabric comprise a plurality of strands in a range from 36 to 144.
11. A collapsible medical device, comprising: a tubular woven metal fabric including a plurality of metal braided strands and having a proximal end and a distal end, each end having a clamp attached to said metal fabric to thereby gather said strands together and inhibit unraveling of the strands, said medical device having a collapsed configuration for delivery through a channel in a patient's body and a double disk shaped expanded preset configuration for substantially creating an occlusion of an abnormal opening in a body organ, the medical device in its expanded configuration having two expanded disk end portions and a reduced diameter middle cylindrical portion disposed between the two disk end portions, the disk end portions and middle cylindrical portions being connected by a reduced diameter portion that is smaller in diameter than both the disk end portions and middle cylindrical portions.
12. The device of claim 11 wherein each expanded disk end portion has an inner and outer wall, the inner wall of at least one of the expanded disk end portions being generally concave.
13. The medical device as recited in claim 11 wherein said means for securing each end has a threaded bore for rotational attachment to a delivery device.
14. The medical device as recited in any one of claims 7 and 11-13 and further including an occluding fiber retained within a hollow central portion formed by said double disk shaped expanded configuration.
15. The medical device as in any one of claims 1-10 and further including a plurality of hook members disposed on the cylindrical portion.
16. A collapsible medical device, comprising a tubular woven metal fabric including a plurality of braided metal strands and having a proximal end and a distal end, each end having a clamp attached to said tubular woven metal fabric to thereby gather said strands together and inhibit the strands from unraveling, said tubular woven metal fabric having an expanded preset configuration shaped to create an occlusion of an abnormal opening in a body organ, said expanded preset configuration being deformable to a lesser cross-sectional dimension for delivery through a channel in a patient's body, wherein the expanded preset configuration comprises two expanded diameter disk portions and a reduced diameter cylindrical middle portion, said middle portion having a length approximating a thickness of a patient's atrial septum, said middle and disk portions being connected by a connection portion having a diameter smaller than both the middle and disk portions, the woven metal fabric having a memory property whereby the medical device tends to return to said expanded preset configuration when unconstrained.
17. The device of claim 16 wherein the connection portion is at least partially recessed within the middle portion.
18. The medical device as recited in claim 16 wherein said clamp has a threaded bore adapted for rotationally receiving a threaded end on a delivery device.
19. The medical device as recited in claim 16, further including an occluding fiber contained within an interior of one of said middle portion and disk portions.
20. The medical device as recited in claim 16 wherein the strands comprise an alloy selected from the group consisting of stainless steel, nickel-titanium, and cobalt-chromium-nickel.
21. The medical device of claim 20 wherein the metal strands have a diameter in a range of from 0.002 to 0.005 inch and the woven metal fabric comprise a plurality of strands in a range from 36 to 144.
CA2609933A 2007-07-12 2007-11-07 Percutaneous catheter directed intravascular occlusion devices Active CA2609933C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11/827,590 US8034061B2 (en) 2007-07-12 2007-07-12 Percutaneous catheter directed intravascular occlusion devices
US11/827,590 2007-07-12

Publications (2)

Publication Number Publication Date
CA2609933A1 true CA2609933A1 (en) 2009-01-12
CA2609933C CA2609933C (en) 2011-03-15

Family

ID=38879277

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2609933A Active CA2609933C (en) 2007-07-12 2007-11-07 Percutaneous catheter directed intravascular occlusion devices

Country Status (15)

Country Link
US (7) US8034061B2 (en)
EP (5) EP2878273B1 (en)
JP (3) JP5248103B2 (en)
KR (1) KR101164479B1 (en)
CN (2) CN103381102B (en)
AT (1) ATE490733T1 (en)
AU (1) AU2007231904B2 (en)
BR (1) BRPI0704145A8 (en)
CA (1) CA2609933C (en)
DE (2) DE602007011049D1 (en)
ES (3) ES2718481T3 (en)
MX (1) MX2007014644A (en)
RU (1) RU2432128C1 (en)
SG (1) SG149740A1 (en)
WO (1) WO2009008868A1 (en)

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