CA2394581A1 - Occlusive coil manufacture and delivery - Google Patents

Occlusive coil manufacture and delivery Download PDF

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Publication number
CA2394581A1
CA2394581A1 CA002394581A CA2394581A CA2394581A1 CA 2394581 A1 CA2394581 A1 CA 2394581A1 CA 002394581 A CA002394581 A CA 002394581A CA 2394581 A CA2394581 A CA 2394581A CA 2394581 A1 CA2394581 A1 CA 2394581A1
Authority
CA
Canada
Prior art keywords
coil
defect
shape memory
shape
anatomical defect
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
CA002394581A
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French (fr)
Other versions
CA2394581C (en
Inventor
Swaminathan Jayaraman
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Individual
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Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2394581A1 publication Critical patent/CA2394581A1/en
Application granted granted Critical
Publication of CA2394581C publication Critical patent/CA2394581C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172—Occluding 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12177—Occluding 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements 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
    • A61B2017/00575—Implements 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements 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
    • A61B2017/00575—Implements 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
    • A61B2017/00592—Elastic or resilient implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements 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
    • A61B2017/00575—Implements 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
    • A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements 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
    • A61B2017/00575—Implements 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
    • A61B2017/00623—Introducing or retrieving devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A61B2017/12095—Threaded connection

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Reproductive Health (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Neurosurgery (AREA)
  • Surgical Instruments (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Materials For Medical Uses (AREA)
  • Control And Safety Of Cranes (AREA)
  • Burglar Alarm Systems (AREA)
  • Glass Compositions (AREA)
  • Prostheses (AREA)

Abstract

The present invention includes a coiled wire (10) formed of a shape memory material for implantation into an anatomical defect. After implantation of o ne or more of the coiled wires (10) according to the present invention, the defect is occluded and thereby corrected or treated. Prior to implantation, the coiled wire (10) is generally elongated and thereafter it reverts to a predetermined shape that is suitable for occluding the defect. At least one clip having at least two prongs may be provided on the wire for attachment t o body tissue. Preferably the wire is made of nickel-titanium. In an alternati ve embodiment, the coil (10) includes a plurality of layers. At least one of these layers is formed of a shape memory material.

Claims (27)

1. A device for occluding an anatomical defect, comprising a member formed of a shape memory alloy, the member having a free bottom end and a free top end, a first predetermined unexpended shape, and a second predetermined expanded shape, wherein the unexpended shape is substantially linear and the expanded shape is substantially conical, the expanded shape having a plurality of loops coaxially disposed about a longitudinal axis, the loops progressively decreasing in diameter from one end of the device to the other, wherein at least one of the ends of the member includes a clip having at least two prongs for contacting areas adjacent the anatomical defect.
2. The device of claim 1, wherein the loops form a substantially conical coil having a constant pitch.
3. The device of claim 1, wherein the loops form a substantially conical coil having a variable pitch.
4. The device of claim l, wherein the shape memory alloy is a nickel-titanium alloy.
5. The device of claim 1, wherein the member is substantially arcuate in cross-section.
6. The device of claim 1, wherein at least one of the prongs has a sharp portion for attaching to an area adjacent the defect.
7. The device of claim 6, wherein the diameter of the plurality of loops is smaller than about 1.5 cm.
8. The device of claim 7, wherein the shape memory alloy displays a one-way shape memory effect.
9. The device of claim 8, wherein the shape memory alloy displays a two-way shape memory effect.
10. The device of claim 8, wherein the shape memory alloy has an austenite finish temperature below body temperature, thereby permitting the device to have superelastic properties at body temperature.
11. The device of claim 8, wherein the shape memory alloy displays a superelastic effect at body temperature.
12. A device of claim 1, wherein the shape memory alloy member includes a plurality of layers.
13. The device of claim 12, wherein the plurality of layers includes at least one layer formed of a passive memory material.
14. The device of claim 12, wherein the plurality of layers includes at least two layers formed of active memory materials.
15. The device of claim 14, wherein at least one of the layers is a wire formed of a shape memory material, and at least one of the layers is a braid formed of a shape memory material.
16. The device of claim 12, wherein the plurality of layers includes at least two layers braided together or one layer surrounded by a braid.
17. The device of claim 1 further comprising at least one crooked section, a substantially conical section, and a substantially cylindrical section disposed between the crooked section and the conical section.
18. A method of occluding an anatomical defect in the vascular tree of a mammal, comprising:
delivering a member formed of a shape memory alloy in a first, substantially straight configuration to an anatomical defect in the body, the member having a temperature below a first transition temperature; and allowing the member to warm above a second transition temperature and form a second, predetermined, coiled configuration having an end with a clip having at least two prongs, wherein the prongs contact areas adjacent the anatomical defect for occlusion of same.
19. The method of claim 18, wherein the second, predetermined, coiled configuration is substantially conical.
20. The method of claim 18, wherein the second, predetermined, coiled configuration comprises a substantially conical section ending at a free end, at least one crooked section, and a substantially cylindrical section disposed therebetween.
21. The method of claim 18, wherein the second, predetermined, coiled configuration is generally at least one of circular, rectangular, offset coiled, concentric coiled, and combinations thereof.
22. A method of manufacturing a superelastic device for placement inside an anatomical defect, the method comprising:
providing an inner mandril of a preselected shape for supporting a coil of a wire formed of a shape memory material;
winding the wire about the mandril to create a coil conforming to the mandril shape;
providing an outer mold to completely surround the coil and mandril and thereby constrain movement of the wire with respect to the mandril;
heating the outer mold for a predetermined period of time while the outer mold surrounds the coil and mandril; and allowing the coil to cool.
23. A device for occluding an anatomical defect, comprising a member formed of a shape memory alloy, the member having a free bottom end and a free top end, a first predetermined unexpanded shape, and a second predetermined expanded shape, wherein the unexpanded shape is sufficiently compact for delivery of the device to the defect and the expanded shape is sufficiently enlarged to occlude the defect by providing a plurality of inner loops and at least one outer loop coaxially disposed about a longitudinal axis, the inner loops progressively decreasing in diameter from a wide end of the device to a narrow end of the device, the at least one outer loop having a diameter greater than the diameter of the inner loops at the narrow end of the device.
24. The device of claim 23, wherein the device includes at least two prongs for contacting areas adjacent the defect.
25. A method of delivering a device for occluding an anatomical defect, the method comprising the steps of:
providing a coil having a proximal portion, a transition portion, and a distal portion, and further having an initial length;
placing the coil in a movable sheath for delivery to the defect;
delivering the movable sheath through the anatomical defect, the anatomical defect having a near side, an inner region, and a far side;
withdrawing a portion of the movable sheath from the anatomical defect and allowing the distal portion of the coil to emerge from the sheath;
allowing the distal portion of the coil to reach body temperature and expand to a spiral configuration at the far side of the anatomical defect;
withdrawing a further portion of the movable sheath from the anatomical defect and allowing the further portion of the coil to emerge from the sheath;
and allowing a further portion of the coil to reach body temperature and expand within the anatomical defect.
26. The method of claim 25, wherein the further portion of the coil is the transition portion which expands within the inner region of the anatomical defect.
27. The method of claim 26, wherein the method further comprises the steps of:
withdrawing an additional portion of the movable sheath from the anatomical defect and allowing the proximal portion of the coil to emerge from the sheath;
and allowing the proximal portion of the coil to reach body temperature and expand to a spiral configuration at the near side of the anatomical defect.
CA002394581A 1999-12-23 2000-12-21 Occlusive coil manufacture and delivery Expired - Fee Related CA2394581C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US17159399P 1999-12-23 1999-12-23
US60/171,593 1999-12-23
PCT/US2000/034889 WO2001045571A1 (en) 1999-12-23 2000-12-21 Occlusive coil manufacture and delivery

Publications (2)

Publication Number Publication Date
CA2394581A1 true CA2394581A1 (en) 2001-06-28
CA2394581C CA2394581C (en) 2009-11-24

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA002394581A Expired - Fee Related CA2394581C (en) 1999-12-23 2000-12-21 Occlusive coil manufacture and delivery

Country Status (9)

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US (2) US6790218B2 (en)
EP (1) EP1239780B1 (en)
JP (1) JP2003517869A (en)
AT (1) ATE406842T1 (en)
AU (1) AU774515B2 (en)
CA (1) CA2394581C (en)
DE (1) DE60040165D1 (en)
DK (1) DK1239780T3 (en)
WO (1) WO2001045571A1 (en)

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