CA2144725C - Large diameter vasoocclusion coil - Google Patents

Large diameter vasoocclusion coil Download PDF

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Publication number
CA2144725C
CA2144725C CA002144725A CA2144725A CA2144725C CA 2144725 C CA2144725 C CA 2144725C CA 002144725 A CA002144725 A CA 002144725A CA 2144725 A CA2144725 A CA 2144725A CA 2144725 C CA2144725 C CA 2144725C
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CA
Canada
Prior art keywords
coil
helical coil
helical
vessel
shaped structure
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.)
Expired - Fee Related
Application number
CA002144725A
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French (fr)
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CA2144725A1 (en
Inventor
Uriel Hiram Chee
Mike Mariant
Erik T. Engelson
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
Target Therapeutics Inc
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Filing date
Publication date
Application filed by Target Therapeutics Inc filed Critical Target Therapeutics Inc
Publication of CA2144725A1 publication Critical patent/CA2144725A1/en
Application granted granted Critical
Publication of CA2144725C publication Critical patent/CA2144725C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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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
    • 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
    • A61B17/1214Coils or wires
    • A61B17/12145Coils or wires having a pre-set deployed three-dimensional shape
    • 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

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Reproductive Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Neurosurgery (AREA)
  • Surgical Instruments (AREA)
  • Disintegrating Or Milling (AREA)
  • Filling Or Discharging Of Gas Storage Vessels (AREA)
  • Magnetic Resonance Imaging Apparatus (AREA)
  • Burglar Alarm Systems (AREA)

Abstract

A device for occluding a large diameter (1 to 3 cm) vessel. The device comprises a helical coil (10) having a multiplicity of windings (14). The helical coil (10) may further be shaped into a variety of structures including a C-shape, a cloverleaf, and a figure 8.

Description

WO 94/11051 ~ ~ ~7 ~ ~ PCT/US93/00882 LARGE DIAMETER VASOOCCLUSION COIL
Technical Field This invention is in the general field of surgical instruments. More particularly, it relates to a vasoocclusion device that can be used in cardiovascular and endovascular procedures. .
Vasoocclusion devices are surgical implements that are placed within vessels, typically via a catheter, to block the flow of blood through the vessel.
Vasoocclusive coils have been used to occlude vessels in small-diameter, difficult to reach sites. United States Patent No. 4,994,069 provides a vasoocclusive wire that is guided to a vessel that has a diameter of between 0.5 and 6 mm. The patent describes a flexible vasoocclusive wire that ie designed to occlude a vessel when the wire is released into the vessel. The diameter of the coiled wire is betweea about 10-30 mils, the wire itself has an outside diameter of between about 2-6 mils and there are about 4-8 helical windings. For vasoocclusion of a vessel that is 0.5-2 mm, the wire has a preferred length 0~ about~3-6 cm, and for a vessel that is 2-6 mm, the wire has a preferred length of about 5-10 cm.
The above described coils, therefore, are effective to occlude vessels of between about 0.5 and 6 mm which require tortuous path access. Where, however, the vessel is between about 1-3 cm, the coils were 21 44~ 2 5 w.. _2_ thought to be impractical as they would be too long to be reliable and might occlude neighboring vessels.
~; gc-i ~RmrP of the Invention It is therefore an aspect of the present invention to provide a vasoocciusive device that can be used to occlude large diameter vessels. The device is a vasoocclusive coil that assumes a linear helical configuration when stretched and a folded convoluted configuration when relaxed. The stretched condition is used in placing the coil at the desired site and the coil assumes its relaxed configuration once the device is so placed.
The vasoocclusive device is a helical coil -having a multiplicity of windings between a first and second end wherein the primary coil diameter is between about 0.25 and 1.5 mm and the diameter of the vessel to be occluded is between about 1.0 and 3.0 cm. Once relaxed, the coil may assume a secondary coil diameter approaching that of the selected vessel.
Hr;ef Descriy~tion of the Drawings Figs. 1 to 9 are fragmentary elevational views (not to scale) of embodiments of the helical coil of the invention.
In the drawings, like structures are referred to by the same reference numeral.
Modes for Carrvina Out the Invention , .~_Fig. 1 depicts one embodiment, generally designated 10, of the helical vasoocclusive coil of the invention. The helical coil 10 will typically be made of a radiopaque material such as platinum, tungsten, gold, stainless steel, or of alloys such as tungsten and platinum. A tungsten-platinum alloy is preferred because 21 4 4 7 2 5 _3-of its strength and toughness. The material desirably is radiopaque and the diameter of the wire will usually be in the range of 0.05 to 0.25 mm. The coil has a multiplicity of individual windings 12. The axial length of the coil will usually be in the range of 0.2 to 100 cm, more usually 0.2 to 40 cm and the diameter of the coil will normally be 0.25 and 1.5 mm, more usually 0.5 to 1.0 mm. The coil will typically have about 40 to 200 windings per cm, more typically about 50 to 130 windings per cm.
The steps in the construction of the vasoocclusion coils of this invention are shown in Figs.
1-3. The coil itself may be formed by wrappings of windings of a fine radiopaque wire thread, preferably 5 to 8 mil (0.13 to 0.20 mm) platinum, tungsten, gold, stainless steel or alloy thread which is available, for example, from California Fine Wire Company (Grower City, CA). The windings are preferably made by wrapping the thread on a spinning mandrel, according to known coil-manufacturing methods. The wire advance on the mandrel is adjusted to produce a single-layer coil with a minimum helical pitch, i.e., in which the windings are closely packed. Typically, the mandrel has a diameter of between about 0.10 and 1.0 mm yielding a coil whose outer diameter is between about 0.25 and 1.5 aan. The soft, flexible coil produced on the mandrel ie cut to a desired length of between about 4 and 100 cm after removal from the mandrel.
The coiled wire may then be wound on a larger diameter mandrel to form a helical winding as shown in Fig. 2 whose helix diameter, indicated at 14, is approximately that of the vessel for which the coil is intended. The helical axis is indicated at 16. Thus for a wire designed for vasoocclusion of a vessel of about 1-3 cm, the diameter of this secondary helical winding is WO 94/11051. ~ ~ ~ ~ ~ ~ ~ PCT/US93/00882 preferably 1-3 cm, respectively. It can be appreciated from the above-mentioned wire lengths and winding diameters, that the wires typically will contain 1-20 helical windings, more typically 4-8 helical windings as illustrated in Fig. 2.
The coil may further be prefortned to contain irregularities in the helical winding, such that the coil adopts a folded, convoluted conformation in a relaxed condition as illustrated in Fig. 3. As seen, the irregularities in this embodiment are such as to offset the helical axis (indicated by arrows in the figure) of each winding by 20-40 degrees. The irregularities are preferably made by deforming, as by twisting, the coil in the region of desired bends with the coil on the helical winding mandrel. The coil may treated by heating at about 800°F for about 24 hours for memory retention after it is shaped.
According to an important feature of the invention, the combination of the helical winding and the irregularities in the winding cause the coil to form a randomly shaped, substantially apace-filling mass when released into a vessel, as will be illustrated below. In particular, the memory in the coil is effective to return the coil from a stretched, linear condition in which it is advanced through a catheter to a randomly oriented, space-filling relaxed~condition as the coil is released from the catheter.
The coil just described may be thought of as having a primary structure fotlned by the wire wrapping making up_the coil, a secondary structure formed by the helical winding of the coil, and a tertiary structure formed by the irregularities in the winding of the coil.
It will be appreciated that the random shape of the coil in its relaxed condition can be achieved by other, related secondary structures in the coil, such as a T ____~~. ____ ~..~..T____ .

21 4 4 7 2 5 _s_ series of arcs which are interrupted at intervals by bends which orient the arcs in different directions.
In an alternative method of manufacture, the primary helical coil may be wound around a series of mandrels that are held in some unifozin configuration to yield the offset helical shape shown in Fig. 3. Multiple coils may be formed in this way and thereafter the coils may be cut to form individual vasoocclusive coils.
The coil is preferably supplied in prepackaged form in a sterile cannula. The cannula straightens the coil during shipment such that it can be placed within a catheter lumen for delivery to the targeted vessel.
A guidewire is inserted such that a catheter can be guided to the targeted vessel. Once the catheter is in place within a vessel, the guidewire is removed and the coil-containing cannula is placed into engagement with the proximal end of the catheter. The coil is then transferred from the cannula lumen into the catheter lumen by exerting force on the proximal end of the coil.
The coil is advanced through the catheter to the tissue of interest by means a guidewire or coil pusher that pushes against the proximal end of the coil.
Alternatively, water may be injected into the catheter to force the coil through the catheter lumen. The location of the coil may be visualized due to the radiopacity of the helical coil. Once at the site, the coil is plunged from the distal end of the catheter into the targeted vessel.
In an alternative method in which the guidewire ~nnains.iu place during coil ejection, the coil is supplied in a cannula which is adapted to engage the proximal end of a guidewire. Once the guidewire and catheter are in place, the coil-containing cannula is placed into engagement with the proximal end of the guidewire and the coil is transferred from the cannula 21447~~
WO 94/11051 PCT/US93/00882 ", lumen onto the guidewire by exerting force on the proximal end of the coil. The coil is delivered to the targeted site by being pushed with a guidewire, coil pusher or by means of hydraulic injection as described above.
Figs. 1 to 9 show variants of the invention, but for simplicity of explanation, show the shape when the coil is in the catheter lumen (Figs. 1 and 7) and after release of the coil at the targeted site (Figs. 2 to 6, 8 and 9).
Fig. 2 shows a partial side view of the helical coil 10 in its relaxed configuration. Typically the coil 10 will be placed inside the catheter lumen in its linear stretched form (as shown in Fig. 1) until discharged from the end of the catheter at which time the configuration shown in Fig. 2 will be assumed.
Fig. 3 shows another embodiment of a vasoocclusive coil of the invention after it has been released from the end of the catheter. The coil loops back upon itself to form a secondary coil having a tertiary configuration that may substantially fill the vessel to be occluded. Irregularities in the coil windings allow formation of the folded convoluted conformation in the coil s relaxed condition. As seen, the multiple convolutions or irregularities in the embodiment are such as to offset the helical axis (the arrows in Fig. 3) of each winding by 20-40 degrees.
Figs. 4, 5, and 6 each illustrate a different aspect of the invention. Whereas Fig. 3 shows a helical coil that fogs a tertiary shape that is circular, Figs.
4-6 show~additional coils whose tertiary structures are also useful in the invention. Fig. 4 shows a cloverleaf-shaped vasoocclusive coil, Fig. 5 shows a figure-8-shaped and Fig. 6 shows a C-shaped vasoocclusive coil. The tertiary structures are the relaxed configurations of the WO 94/11051 ~ ~ ~~ ~ ~ PCT/US93/00882 _.. -?-coils after release into the vessel. The devices are introduced as helical coils as shown in Fig. 1 and then assume the shapes shown. The maximum helical coil diameters of the coils shown as 20, 22 and 24 are equivalent to the size of the vessel to be occluded, that is 1-3 cm.
Figures 7 and 8 show a vasoocclusive coil such as is described above, but in which irregularities in the helical winding are produced by flattening the wire coil in different directions. This may be accomplished by flattening or squeezing the linear coil 30 in a number of places 32 along the winding at various angles (if so desired) such as ie shown in Fig. 7. The coil so formed will have the general appearance shown is Fig. 7 when in its linear configuration. The coil will be in its linear configuration as shown in Fig. 7 during its introduction into the vessel, but will assume the shape shown in Fig.
8 when in its relaxed configuration.
Fig. 9 shows a coil having a primary coil structure as described above, with a helical winding 40 having at least one helical turn whose diameter 42 is the size of the vessel to be occluded. In this variation, the irregularities in the helical winding take the fozm of continually changing helical diameters fotmiag spirals which are dimensioned to span the cross-sectional area of the vessel.
The coils of the present invention, therefore are useful for occluding vessels in the range of about 1 to 3 cm. Such applications include the occlusion of fistulas of the pulmonary vasculature in the lungs, trauma in the periphery, arteriovenous malformations, heart anomalies and aneurysms.
Modifications of the above-described modes for carrying out the invention that are obvious to those of skill in the fields of medical device design generally, 2~ 44725 and vasooccluaion specifically are intended to be within the scope of the following claims.
Although preferred embodiments of the invention have been described herein, it will be understood by those skilled in the art that variations, modifications, and equivalents may be made thereto without departing from the spirit of the invention or the scope of the appended claims.

Claims (12)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A vasoocclusive device comprising a primary helical coil having a multiplicity of windings between a first and second end, wherein the diameter of the primary helical coil is between about 0.25 and 1.5 mm and the diameter of the vessel to be occluded is between about 1.0 and 3.0 cm.
2. The vasoocclusive device of claim 1 wherein the helical coil is from about 0.2 to 100 cm in length and has about 40-200 windings per cm.
3. The device of claim 1 wherein the helical coil assumes a secondary helical coil-shaped structure with between about 4-8 windings.
4. The device of claim 3 wherein the diameter of the secondary helical coil-shaped structure is between about 1.0 and 3.0 cm.
5. The device of claim 3 wherein the helical coil assumes a tertiary structure formed by irregularities in the windings of the secondary helical coil-shaped structure.
6. The device of claim 1 wherein the helical coil assumes a secondary cloverleaf-shaped structure.
7. The device of claim 1 wherein the helical coil assumes a secondary figure 8-shaped structure.
8. The device of claim 1 wherein the helical coil assumes a secondary C-shaped structure.
9. The device of claim 1 wherein the helical coil assumes a secondary randomly-shaped structure.
10. The device of claim 9 wherein the randomly-shaped structure forms a substantially space-filling mass when released into the vessel.
11. The device of claim 1 wherein the helical coil assumes a secondary structure of continually changing helical diameters forming spirals.
12. The device of claim 11 wherein at least one spiral is dimensioned to span the cross-sectional area of the vessel to be occluded.
CA002144725A 1992-11-19 1993-02-03 Large diameter vasoocclusion coil Expired - Fee Related CA2144725C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US97823092A 1992-11-19 1992-11-19
US07/978,230 1992-11-19
PCT/US1993/000882 WO1994011051A1 (en) 1992-11-19 1993-02-03 Large diameter vasoocclusion coil

Publications (2)

Publication Number Publication Date
CA2144725A1 CA2144725A1 (en) 1994-05-26
CA2144725C true CA2144725C (en) 2000-06-06

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CA002144725A Expired - Fee Related CA2144725C (en) 1992-11-19 1993-02-03 Large diameter vasoocclusion coil

Country Status (6)

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EP (1) EP0743866A1 (en)
JP (1) JPH08500273A (en)
AU (1) AU681073B2 (en)
CA (1) CA2144725C (en)
IL (1) IL104870A0 (en)
WO (1) WO1994011051A1 (en)

Cited By (2)

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US9011480B2 (en) 2012-01-20 2015-04-21 Covidien Lp Aneurysm treatment coils
US9050095B2 (en) 2004-09-22 2015-06-09 Covidien Lp Medical implant

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US6705323B1 (en) 1995-06-07 2004-03-16 Conceptus, Inc. Contraceptive transcervical fallopian tube occlusion devices and methods
US6270495B1 (en) 1996-02-22 2001-08-07 Radiotherapeutics Corporation Method and device for enhancing vessel occlusion
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US6709667B1 (en) 1999-08-23 2004-03-23 Conceptus, Inc. Deployment actuation system for intrafallopian contraception
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US7033374B2 (en) 2000-09-26 2006-04-25 Microvention, Inc. Microcoil vaso-occlusive device with multi-axis secondary configuration
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US7029486B2 (en) 2000-09-26 2006-04-18 Microvention, Inc. Microcoil vaso-occlusive device with multi-axis secondary configuration
JP4109627B2 (en) * 2001-11-07 2008-07-02 マイクロ ベンション インコーポレイテッド Microcoil vascular occlusion device with multi-axis secondary shape
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DE502004010411D1 (en) 2004-09-22 2009-12-31 Dendron Gmbh DEVICE FOR IMPLANTING MICROWAVES
US8864790B2 (en) 2006-04-17 2014-10-21 Covidien Lp System and method for mechanically positioning intravascular implants
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WO2008112436A2 (en) 2007-03-13 2008-09-18 Micro Therapeutics, Inc. An implant, a mandrel, and a method of forming an implant
US9579104B2 (en) 2011-11-30 2017-02-28 Covidien Lp Positioning and detaching implants
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Cited By (2)

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Publication number Priority date Publication date Assignee Title
US9050095B2 (en) 2004-09-22 2015-06-09 Covidien Lp Medical implant
US9011480B2 (en) 2012-01-20 2015-04-21 Covidien Lp Aneurysm treatment coils

Also Published As

Publication number Publication date
CA2144725A1 (en) 1994-05-26
JPH08500273A (en) 1996-01-16
WO1994011051A1 (en) 1994-05-26
AU681073B2 (en) 1997-08-21
AU3603793A (en) 1994-06-08
EP0743866A1 (en) 1996-11-27
EP0743866A4 (en) 1996-07-26
IL104870A0 (en) 1993-06-10

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