CA2113587A1 - Vasoocculsion device containing radiopaque fibers - Google Patents

Vasoocculsion device containing radiopaque fibers

Info

Publication number
CA2113587A1
CA2113587A1 CA002113587A CA2113587A CA2113587A1 CA 2113587 A1 CA2113587 A1 CA 2113587A1 CA 002113587 A CA002113587 A CA 002113587A CA 2113587 A CA2113587 A CA 2113587A CA 2113587 A1 CA2113587 A1 CA 2113587A1
Authority
CA
Canada
Prior art keywords
fibers
braided
radiopaque
radiolucent
tubular member
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.)
Abandoned
Application number
CA002113587A
Other languages
French (fr)
Inventor
Erik T. Engelson
Gene Samson
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.)
Target Therapeutics Inc
Original Assignee
Erik T. Engelson
Gene Samson
Target Therapeutics, Inc.
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 Erik T. Engelson, Gene Samson, Target Therapeutics, Inc. filed Critical Erik T. Engelson
Publication of CA2113587A1 publication Critical patent/CA2113587A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • 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
    • A61B17/12113Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • 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
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • 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
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • 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
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0108Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers

Abstract

ABSTRACT OF THE INVENTION

This invention is a vasoocclusive device. More particularly, it is a tubular vasoocclusion braid woven from at least radiopaque fibers. The braid may also be partially woven from radiolucent fibers. Optionally, the device may contain a fibrous center or wick in its interior. The device may be continuous or segmented and a fibrous covering or element may be attached.

Description

2113~87 , ;~ , ,~

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~ 5 VASOOCCLUSION DEVIC~ CONTAINING RADIOPAOU~ FIBERS
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Field of the I~ve~ion This invention is a vasoocclusive device. More particularly, it 18 a tubular vasoocclusion braid woven I from at least radiopaque fibers. The braid may also be partlally woven from radiolucent fibers. Optionally, the device may contain a flbrous center or wick in it i 15 interior. The device may be continuous or segmented and a fibrous covering or element may be attached.

Background of the Invention Vasoocclusion devices are surgical implements that are placed within the vascuIature of the human body, typically via a catheter, either to block the flow of blood through the vessel making-up that portion of the vasculature or to fonm a clot within an aneurysm stemming fron the vessel. one widely used vasoocclusive device is a helical wire coil having windings that are dimensioned to engage the walls of the vessels. Fibers may also be woven or laid crosswise through the windings to provide a sub~trate for clot formation and tissue growth within the chosen site. Coils having such a structure are readily commercially available.
U.S. Patent N`umber 4,994,069, to Richart et al., de w ribes a vasoocclusive coil which assume~ a ~i linear helical configuration when stretched, and a folded J, convoluted configuration ~hen relaxed. The coil is i 35 introduced into the human body in a stretched condition.

.~ .

2113a87 . .

When the coil reaches its intended site, the coil assumes its relaxed condition -- which is better suited to occlude the vessel -- and restricts blood flow beyond the space that it occupies.
U.S. Patent No. 5,226,gl1 to Chee et al.
teaches a helical vasoocclusion coil to which fibrous elements are attached in such a way that they will not be dislodged from the coil. The fibrous elements enhance the ability of the coil to fill space within the vasculature and to facilitate clot formation and tissue growth.
Care must be taken in creating combination fibroue vasoocclusive elements, i.e., those containing multiple cores and fibrous elements, since the fibrous elements may come off and migrate to vessels supplying blood to normal tissue. Fibrous elements, since they are not normally radiopaque, are difficult to find and to retrieve if separated from the metallic coil.
Nevertheless, it is desireable to increase the ratio of ---fibrou~ element to the metallic coil since the fibrous element increases the tendency of the coil assembly to --cause embolic and tissue growth. --The inventive vasoocclusive braid is desireable in that the ratio of fibrous material to metallic ---material is quite high, the fibrous material is held firmly in place due to the braided or woven configuration, and is easily placed within the body's vasculature.

Sun~K~c~ of the I~yen~Qa This inventlon is a vasoocclusive device comprising:
(a) a braided member which may be segmented, contlnuous, or segmented having a gap between the two end portion~, but ln each case having a first end and a 2113~7 ~ `

second end and woven at least from radiopaque fibers but optionally partially woven from radiolucent fibers; and optionally (b) at lea~t one fibrous woven element or 5 covering attached to the exterior of the braid, and -(c) a fibrous wick or center as the core of the braided member.

Brief De~c~ie~ion of the ~rawings Figure 1 is a ~chematic depiction of an overall system for introducing the inventive devices into the vessel of a human body.
Figures 2-5 are side views, partial cross-sectional side view~, or partial cutaway sideviews of a number of embadiments of the inventive vasoocclusive device.

Descri~tion o$ the Invention The vasoocclusive devices of this invention may be used in a manner similar to those described in U.S.
Pat. No. 4,994,069. Briefly, the inventive devices may be supplied in a pre-pac~aged form in a sterile cannula which is adapted to engage the prox;mAl end of a catheter. As is sho~n in Figure 1, once the catheter (100) is in place ~ithin a vessel (102) -- for instance, the distal end (104) of the catheter llOO) at an aneurysm ~106) -- the braid-containing cannula is placed into engagement with the proximal end of the catheter and the braide are transferred from the cannula lumen into the catheter lumen by exerting force on the proximal end of the coil. A flexible pu~her device ~10~) may be used to push the braid ~110) through the catheter ~100) to the deeired relea~e slte. The location o~ the braide ~110) may be observed due to the radiopaclty o~ the metallic etrands in the braid. Once at the eite, the braids are ., " ~
2~13~87 singly plunged from the catheter lumen into the ve~sel qite (106). ~ -Figure 2 depicts one embodiment of the va~oocclusive braid of the invention, generally ~hown as (120). The vasoocclusive device (120) has several component~: a first end (122), a ~econd end (124), and a braided or woven tubular fibrous element (126) extending from the first end (122) to a similar position on the second end (124). The tubular element (126) may be made up completely or partially of regular or randomly included radiopaque wlres (128) and optionally may be partially woven of, or cowoven with, radiolucent fibers or wires (130). The braided member may be woven using known weaving techniques and devices to form the tubular member (126) shown in this and the other figures.
Caps (122) and (124), variously in this configuration and in the others discussed herein, may be made of a radiopaque material such as platinum, tungsten, gold, silver, or alloys thereof, or other suitable generally radiopaque metals which are otherwise biologically inert. Radiopacity for the cap~ (122) and (124) is, of course, optional since the braid itself --contains radiopaque wires. The caps ~122) and (124) may be produced from a polymeric material or glue which seals the wires into the fibrous tubular element and keeps it from unraveling.
The diameter of the wire or fiber used in production of the braid will typically be in the range of 0.0005 and 0.005 lnches. The resulting woven braid diameter will normally be 0.008 to 0.018 inches.
Preferably, the braid diameter is 0.015 to 0.018 inches.
The wire may be a radlopaque material such as a metal or polymer, which polymer may be filled with a radiopaque material such a~ po~dered tantalum. Suitable metals and alloys include the platinum group metals especially 21135~7 platinum, rhodium, palladium, and tungsten, gold, silver, ~ tantalum, or alloys thereof. Preferred is a platinum-s tungsten alloy.
The wire may also be any of a variety of 5 stainless steels but may be made of other appropriate ~ materials including shape memory or highly elastic alloys i such as nickel-titanium alloys (48-58 atomic % nickel and 3 optionally containing modest amounts of iron); copper-zinc alloys (38.5-41.5 weight % zinc); copper-zinc alloys 10 containing 1-10 weight ~ of beryllium, silicon, tin, aluminum, or gallium; or nickel-aluminum alloys (36-38 atomic ~ aluminum). Particularly preferred are the alloy3 described in U.S. Pat Nos. 3,174,851, 3,351,463, and 3,753,700. Bspecially preferred is the Ti-Ni alloy 15 known as nitinol. Nitinol wire having the proper transition temperature allows the device to be introduced through the catheter in a linear fashion and upon raising the temperature of the vasoocclusive braid to body temperature, the wire in that braid assumes its pre-20 selected shape.
The radiolucent fibers may be made from biocompatible materials such as Dacron (polyester~, polyglycolic acid, polylactic acid, fluoropolymers (polytetrafluoroethylene), Nylon (polyamide), or silk.
25 The strands forming the braid should be reasonably heavy, e.g., having tensile strength of greater than about 0.15 pounds. Preferred materials are Dacron strands.
¦ The fibrous elements incorporated into the braid may be a bundle of individual fibers, e.g., between 30 5 and 100 flbers per fibrous bundle, preferably 20 to 30 fibers per bundle, or may be monofilaments.
The axial length of the braid will usually be in the range of 0.5 to 100 cm, more usually 2.5 to 40 cm.
Figure 3 shows another varlatlon of the inventive vasoocclusive device (140). In this variation, .. , ... ~

: , ,. . .~ . ~ . . .

2113587 ~

the tubular braid (142) contains a slightly higher incidence of radiopaque wires (12 a ) than the braid shown in Figure 2. This aspect is ~hown merely for the purpose of illustration. A3 noted above, the intent is to include at least radiopaque elements and optionally radiolucent elements which enhance the embolic features of the inventive braid. More importantly, Figure 3 shows the use of outlying fibers (144) which have been tied (or otherwise attached) to the tubular braid fibers. These fibers (144) are tied at various intervals to increase the propensity of the device to occlude blood. The outlying fibers (144) are typically Dacron but may be any of the natural and manmade fibers listed above.
Figure 4 shows another variation (150) of the inventive device in which tassels (152) are tied to the tubular braid to increase the breadth of the device and increase its overall clotting ability. These tassels are typically Dacron but, again, may be any of the fibrous materials described above. The tassels (152) may be short or long and may be singular or multiple depending upon the use intended.
Figure 5 shows a cutaway sideview of the invenSive device in which the braided tubular vasoocclusion device discussed above contains a core of radiolucent fibers. Although the fibers making up the braided tube may be radiolucent or radiopaque, the radiopaque fibers are preferred. The interior core of the braided tubular occlusion device (154) contains a bundle of radiolucent fibers (156) extending from one end of the braided tube to the other. The fiber bundle may be made up of fibers selected from those thermoplastics and natural materials noted above. The ends of the bundle may be ~ealed by heating those ends where the material~ 80 allow. The bundle may be pre-filled or infused with drugs ~ultable for later hastening of . , : : ,, ; . - . - .:

~, . . . .

coagulation after the device i8 introduced into the selected vascular site. The vasoocclusive device of IFigure 5 may also have outlying fibers attached to the !braided tubular element as has been discussed generally ! 5 above.
¦The braided ccclusion devices may be made in a variety of ways, as should be apparent from the ¦discussion above. The devices may be strung on a guidewire or other similar device for installation, ¦10 necessitating that the braided tubular device have open ends for pascage of the guidewires. The ends may be closed if 80 desired.
The ultimate shape of the device is a matter of choice. We contemplate that it may be straight, as introduced into the body lumen, or may be C~ shaped, circular, figure ~8~, random, or any other shape desirable to the physician user in view of the physical situation to be resolved.
Modifications of the above-described variations for carrying out the invention which are obvious to those of ordinary skill in the fields of medical device design generally, and vasoocclusion devices specifically, are intended to be within the scope of the following claims.

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Claims (17)

1. A vasoocclusive device comprising a tubular member of braided fibers, at least a portion of said braided fibers being radiopaque, and having an interior cavity and a proximal and a distal end and which is of a size suitable for occluding a chosen site within the human vasculature.
2. The device of claim 1 where the tubular member braided fibers also comprise radiolucent fibers.
3. The device of claim 2 where the radiolucent fibers are selected from polyesters, polyglycolic acid, polylactic acid, fluoropolymers, polyamides, and silk.
4. The device of claim 3 where the radiolucent fibers comprise polyester.
5. The device of claim 1 where the radiopaque fibers comprise metals or polymers.
6. The device of claim 5 where the braided radiopaque fibers are selected from platinum, tungsten, gold, silver, tantalum, and alloys thereof, shape memory alloys, and stainless steels.
7. The device of claim 6 where the braided radiopaque fibers comprise a platinum-tungsten alloy.
8. The device of claim 6 where the braided radiopaque fibers comprise a shape memory alloy.
9. The device of claim 8 where at least a portion of the braided radiopaque fibers comprise nitinol.
10. The device of claim 1 additionally comprising braided fibers tied to the fibers in the braided tubular member.
11. The device of claim 10 where the fibers tied to the braided fibers are tied at multiple locations.
12. The device of claim 10 where the fibers tied to the braided fibers are tied so as to form tassels.
13. The device of claim 1 where the braided tubular member contains radiolucent fibers within the interior cavity.
14. The device of claim 13 where the radiolucent fibers in the interior cavity extend from the tubular member's distal end to the tubular member's proximal end.
15. The device of claim 13 where the radiolucent fibers in the interior cavity are selected from polyesters, polyglycolic acid, polylactic acid, fluoropolymers, polyamides, and silk.
16. The device of claim 15 where the radiolucent fibers in the interior cavity comprise polyester.
17. The device of claim 1 where the tubular member of braided fibers has a diameter of 0.015 to 0.018 inches.
CA002113587A 1993-01-15 1994-01-17 Vasoocculsion device containing radiopaque fibers Abandoned CA2113587A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US005,478 1993-01-15
US08/005,478 US5423849A (en) 1993-01-15 1993-01-15 Vasoocclusion device containing radiopaque fibers

Publications (1)

Publication Number Publication Date
CA2113587A1 true CA2113587A1 (en) 1994-07-16

Family

ID=21716084

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002113587A Abandoned CA2113587A1 (en) 1993-01-15 1994-01-17 Vasoocculsion device containing radiopaque fibers

Country Status (11)

Country Link
US (1) US5423849A (en)
EP (1) EP0679069B1 (en)
JP (1) JP2548514B2 (en)
AT (1) ATE224673T1 (en)
AU (1) AU669054B2 (en)
CA (1) CA2113587A1 (en)
DE (1) DE69332341T2 (en)
ES (1) ES2184757T3 (en)
IL (1) IL108182A0 (en)
TW (1) TW240165B (en)
WO (1) WO1994015534A1 (en)

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ATE224673T1 (en) 2002-10-15
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EP0679069A1 (en) 1995-11-02
DE69332341D1 (en) 2002-10-31

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