KR19980069297A - Renal Vascular Occlusion Device - Google Patents

Abstract

The present invention relates to a blood vessel occlusion device. Typically, the present invention relates to a vascular occlusion device comprising a primary spiral wound coil that can be wound into a secondary shape. The subject matter of the present invention utilizes an extension member that extends through the formed lumen, wherein the extension member is fixedly attached to the coil directly or indirectly in at least two positions. Preferably, the extension member is loosened somewhat within the lumen to prevent the coil from collapsing, adhering and tearing while the winding passes through the body. The coil can bend easily. In some variations of the invention, the stretch resistant member may be formed in the coil tip at the end of the coil using a simple mechanism such as solder iron or the like. Typically the tip is the same diameter as the coil body itself. Its main purpose is to prevent the extension of the coil during movement of the coil by reinserting or repositioning it after deployment. The apparatus has a secondary shape that itself forms as a preformed linear spiral winding coil, although it does not have to have a secondary shape. Preferably, the coil is flexible and can be controlled using a cuttable or mechanical joint, such as an electrolytically detachable joint. The outer fiber may be attached to the device and secured to the preformed linear member to increase thrombus formation. The highly flexible variant of the present invention is introduced hydraulically through the lumen of the catheter and reintroduced through the flow oriented catheter. The vascular occlusion member may be covered with fibers. The device is introduced into the body through a catheter. The device passes axially through the catheter sheath, the secondary shape being shaped upon exiting the catheter.

Description

Renal Vascular Occlusion Device

The present invention relates to an implantable vaso-occlusive device. Typically, the vascular occlusion coil comprises a spiral wound primary coil that can be wound into a secondary shape. In the center of the present invention, an extension member is used which extends through the formed lumen. This extensible member is fixedly attached to the coil directly or indirectly in at least two positions. This stretch-resistant member is preferably somewhat loose inside the lumen to prevent the coil from compressing, binding, and thus strengthening during passage of the winding through the body. This coil should be easy to bend. In some variations of the invention, the extension member may be formed at the coil tip at the end of the coil using a simple mechanism such as a soldering iron or the like. The diameter of this tip is equal to the diameter of the coil body itself. The main purpose of such an extension member is to prevent the coil from stretching during movement of the coil, for example, the number of times after deployment or repositioning. Typically, the device may have a self-forming secondary shape made from a helically wound and preformed primary linear coil, although it does not need to have a secondary shape. The coil is extremely flexible and controllable release using shearable or mechanical joints, such as electrolytically detachable joints. The outer fiber may be attached to the device or secured to a preformed linear member to increase thrombus formation. A highly flexible variant of the present invention is conveyed by hydraulic pressure through the lumen of the catheter, so that the flow-oriented catheter is retrievably conveyed. In addition, the vascular occlusion member may be covered with a fiber braid. Typically, the device is introduced into the body through a catheter. The device passes axially through the catheter sheath and exhibits its secondary shape upon exiting the catheter.

Vascular occlusion devices are surgical instruments or inserts that are usually placed within the vascular structures of the human body through a catheter, which block blood flow through the blood vessels that form part of the vascular structure by forming a thrombus, or an aneurysm derived from the blood vessel. It acts to form an embolus within. One widely used vessel occlusion device is a spiral wire coil with a winding that may be sized to engage the vessel wall. Other spiral coils with less rigidity and coils comprising woven braids have also been known. Indeed all such vascular occlusion inserts are carried by the wire guide catheter when the device is pushed through the catheter. Because of the need for a pusher, and because of concerns about the restoration of such a vascular occlusion device when it is misplaced in the body, there should have been a vascular occlusion device of the type conveyed through a flow-oriented catheter similar to the present invention. Not the same

As an example of a previous vessel occlusion device, US Pat. No. 4,994,069 to Ritchart et at. Discloses a vessel occlusion coil that takes a linear helical structure upon stretching and a folded convolutional structure upon relaxation. . This stretch state is used to place the coil (via its advance through the catheter) into the desired site, and as soon as the vessel occlusion device is so placed, the coil has a relaxed structure (more suitable for occluding the vessel). Take it. U.S. Patent No. 4,994,069 discloses various shapes. The secondary shapes of the disclosed coils include the shape of 0b flower 0c and the double vortex. Random secondary shapes are also disclosed.

U. S. Patent No. 5,304, 194 to Chee et al. Discloses vascular occlusion coils to which various secondary shaped fibrous elements are attached. This patent discloses a spiral winding device having a secondary shape in which the fibrous element extends in the form of a sine wave down the length of the coil. Such a coil as disclosed in this patent is made to pass it through a lumen of the catheter in a generally straight structure and form a relaxed or folded shape in a selected lumen or cavity in the body when it is released from the catheter. The fibrous element disclosed in this patent enhances the coil's ability to fill the space in the vasculature and also promote the formation of thrombus and thus the formation of associated tissue.

There are various methods for discharging the shaping coil and the linear coil into the vascular structure of the body. While the patents clearly state that only physically pushing the coil outwards into the vasculature, there are many other ways of releasing the coil at a particular selected time and location. Uglielmi et al., US Pat. No. 5,354,295 and its original patent 5,122,136 disclose electrolytically separable embolic devices.

In addition, various devices that are mechanically detachable are known. For example, US Pat. No. 5,234,437 to Sepetka discloses a method of unscrewing a spiral winding coil from a pusher having an interlocking surface. No. 5,250,071 to Palermo discloses an embolic coil assembly using interlocking clasps mounted on both the pusher and the embolic coil. Engelson 5,261,916 discloses a detachable pusher-vessel closure coil assembly having an interlocking ball and keyhole coupling. 5,304, 195 to Twyford et al. Discloses a pusher-vessel closure coil assembly having an attached proximal extending wire supporting a ball on a proximal end and a pusher having a similar end. These two ends are interlocked and released upon release from the distal tip of the catheter. Parlor 5,312,415 discloses a method of discharging multiple coils from a single pusher using a guidewire having a section that can be interconnected with the interior of the spiral winding coil. No. 5,350,397 to Palermo et al. Discloses a pusher having a throat at its distal end and a pusher passing through it. A pusher sheath is retained on the end of the embolic coil, which will then be released when the axially disposed pusher wire is pushed towards the member on the proximal end of the vessel closure coil.

In addition, blood vessel occlusion coils with little or no inherent secondary shape are known. For example, US patent application filed on November 18, 1992 by Berenstein et al., Filed Ultrasoft Embolization Coils with Fluid-Like Properties 0c with 0b fluid-like properties. No. 07 / 978,320 discloses coils having little or no shape after introduction of blood vessels into the space.

None of these devices is a helical helical coil with an extension member contained therein.

The present invention relates to a vascular occlusion device comprising a spiral winding coil formed by winding a wire with a first or primary helix to form an outer helical member having first and second ends. An extension member extending through the formed lumen is fixedly attached to the coil directly or indirectly in at least two positions. The extension member is preferably held loose in the coil so as to prevent binding of the coil during passage of the coil through the bend in the blood vessel structure.

The primary spiral may be wound into a secondary shape, and may also preferably be heat treated to retain its shape prior to the step of introducing the extension member into the coil. The secondary shape may be to form a particular shape when released from the dispensing catheter. This shape may fill an aneurysm, perhaps a fistula or a vasculature cavity such as an AVM. The stiffness of various parts of the coil may be selected to enhance the usefulness of the vascular occlusion device in certain applications. Highly flexible coils are highly desirable. The fibrous material may be woven or bound into the blood vessel occlusion member or surrounding it to enhance clot formation.

This vascular occlusion device is simply used by temporarily correcting it if necessary and introducing it into a suitable catheter. The catheter is already disposed so that its distal hole is in the mouth or hole of the vessel cavity to be filled. The vascular occlusion device is then pushed through the catheter, which takes its relaxed shape as it exits into the vascular cavity from the distal end of the catheter.

The vascular occlusion device is usually used in the vascular structure of the body to form an embolus, but may be used anywhere in the body where occlusion is required, such as that of the device of the present invention.

Also forming an important embodiment of the present invention is a combination of the vascular occlusion device and the flow oriented catheter of the present invention.

1A is a partial cutaway side view of a vascular occlusion coil made in accordance with the present invention having a generally linear fiber extension member.

1B is a partial cutaway side view of a vascular occlusion coil made in accordance with the present invention having a generally linear wire extension member.

1C is a partial cutaway side view of a vascular occlusion coil made in accordance with the present invention having a generally helical extension member.

2A-2C are partial cutaway side views of representative ends of the vascular occlusion coils of the present invention.

3A, 3B and 3C show partial cutaway side views of a junction that is electrolytically detachable in combination with a vascular occlusion coil made in accordance with the present invention.

4A and 4B are partial cutaway side views of a typical mechanically separable junction in combination with a vascular occlusion coil made in accordance with the present invention.

Fig. 5 shows the C0b-shaped secondary shape for the vascular occlusion device of the present invention.

Fig. 6 is a diagram showing a clover type secondary shape for the blood vessel occlusion device of the present invention.

Fig. 7 is a diagram showing a double loop type secondary shape for the vascular occlusion device of the present invention.

FIG. 8 illustrates bonding an outer fibrous material to the vessel occlusion device of the present invention. FIG.

FIG. 9 illustrates adhering the outer braided fiber material to the vessel occlusion device of the present invention. FIG.

10 is a view of the vascular occlusion device of the present invention assembled with a flow oriented catheter.

11A-11D illustrate a sequence for introducing a vascular occlusion coil into an aneurysm, as can be seen in other figures.

* Description of the symbols for the main parts of the drawings *

100, 200, 210: coil 104, 204: first end

106,206: second end

108, 134, 148, 162, 184, 208, 214, 234: absence of extension resistance

112: outer handle 130, 230: blood vessel occlusion coil

1A-1C are partial cross-sectional (cut) side views of a highly preferred variant for the coils 100, 200, 210 of the present invention.

The variant shown in FIGS. 1A and 1B is formed of helical wound outer coils 102, 202 having first ends 104, 204 and second ends 106, 206. This shape is referred to herein as primary winding or shape. This variant includes stretch resistant members 108, 208, 214 shown to be fixedly attached to the first ends 104, 204 and the second ends 106, 206. In such a situation, the extension members 108, 208 may be attached to only one of the two ends or at least one site between the ends, or not attached to either of the two ends. Clearly, in order to achieve extension resistance, the extension member must be attached to at least two points on the coil.

The stretchable member 108 of the variant shown in FIG. 1A consists of fibers and preferably a polymer. The extensible member 108 may be a thermoplastic or thermoset material and includes a single filament bonded to or melted on a bundle of threads or otherwise fixedly attached to the vascular occlusion coil 100. In some situations, it may also be desirable to include one or more metallic strands in the extension member 108 to provide rigid or electrical conductivity for certain applications.

The extension member 208 of the modification shown in FIG. 1B is fixed to the coil at one or more positions of the first end 204, the second end 206, or the middle of these ends by soldering, soldering, adhesive, or the like. It can be a simple wire or ribbon attached.

1C illustrates a spiral wound coil fixedly attached to a coil at one or more positions in the first end 204, the second end 206, or the middle of these ends by solder, solder, adhesive, or the like. It may include an extensible resistant member 214. The stretchable member 214 of this shape provides a measure of lateral flexibility greater than the modified wire 208 (FIG. 1B). It may be wound in the same direction as the outer coil 202 or in other directions. A reasonable disadvantage of this variant is that it can be stretched more than the variant of FIG. 1B when pressed in the axial direction.

The materials used to construct the vascular occlusion coils 102, 202 and the internal extension members 108, 208, 214 can be one of a wide range of materials, preferably radiopaque materials such as metals or polymers. Suitable metals and alloys for the wires that make the primary coils 102, 202 and the extension members 108, 208, 214 include platinum group metals, particularly platinum, rhodium, palladium, rhenium, as well as tungsten, gold, Silver, tantalum and alloys of these metals. These metals are quite radiopaque and may be made by these alloys to suitably balance flexibility and stiffness. They are also highly biologically inactive. Very good materials are, for example, platinum / tungsten alloys with 8% tungsten and the balance platinum.

In addition, the ribbon or coil extensible members 208 and 214 may be made from a wide range of stainless steels where it is acceptable to sacrifice some of the radiopacity and flexibility. From a mechanical point of view, a very preferred component is a material that retains its shape even when high stress is applied. Examples of 0b superelastic alloys 0c include nickel / titanium alloys (48-58 atomic% nickel and optionally containing appropriate amounts of iron); Copper / zinc alloy (38-42 weight percent zinc); Copper / zinc alloys containing 1 to 10% by weight of beryllium, silicon, tin, aluminum or gallium; Or a nickel / aluminum alloy (36 to 38 atomic percent aluminum). Especially preferred are the alloys described in US Pat. Nos. 3,174,851, 3,351,463 and 3,753,700. Particularly good is the titanium / nickel alloy known as 0c nitinol 0b. This is a very strong alloy that can withstand fairly large bends without deformation even when very small diameter wires are used.

When a superelastic alloy such as nitinol is used in the device, the diameter of the coil wire is considerably smaller than the wire diameter used when using a relatively softer platinum or platinum / tungsten alloy as the constituent material.

Coils may be made of radiation semipermeable fibers or polymers (or radiation semipermeable or radiopaque) such as dichron (polyester), polyglycolic acid, polylactic acid, fluoropolymer (polytetrafluoro-ethylene), nylon (polyamide) or even silk. It may also be made of metallic threads coated with fibers. When the polymer is used as the main component of the vascular occlusion coil member, it is preferable to fill a small amount of known radiopaque materials such as powdered tantalum, powdered tungsten, bismuth oxide, barium sulfate and the like.

First, the coil material is wound into the primary coils 102, 202. The primary coil is generally linear after being wound. Generally speaking, when the coils 102 and 202 are metallic coils and when the coils are superelastic alloys or platinum alloys such as nitinol, the diameter range of the wires used in the manufacture of the coils 102 and 202 is 0.00025 inches to 0.006 inches. The wire is wound into primary coils 102 and 202 having a primary diameter of 0.003 inches to 0.025 inches. For most neurovascular applications, the preferred diameters of the primary coils 102, 202 are 0.008 to 0.018 inches. The coil wire is intended to hold the device in place at selected body parts, lumens or cavities without expanding the walls of the body parts and moving away from the body parts as a result of repetitive fluid waves found within the vascular system. It may have a diameter sufficient to provide sufficient hoop strength to the final device. However, the present invention allows the user to use a very flexible packing assembly with very high packing performance. For example, coil wires with wire diameters of 0.00015 inches or less are suitable for such highly flexible devices. Typically the coil diameter may be 0.015 inches or less. The coil wire will drop more than about 20 °, preferably 35 ° to 90 °, when about 1 cm of the primary form of the coil with the free end is kept horizontal.

The axial length of the primary coil is usually included in the range of 0.5 to 100 cm, more typically 2.0 to 40 cm. Depending on the application, the coil may have 10 to 75 turns per cm, preferably 10 to 40 turns per cm. All dimensions herein are provided for guidance only and are not critical to the invention. However, only dimensions suitable for use in occluded areas within the human body are included within the scope of the present invention.

When the primary coils 102, 202 are wound up, the extension members 108, 208 are inserted into the lumen of the primary coils 102, 202 and secured to the coils as needed. The ends 104, 204, 106, 206 preferably have the same diameter as in the primary coils 102, 202.

Suitable polymeric materials for the polymeric stretchable member 108 can be either thermoset or thermoplastic materials. Thermoplastic materials are preferred because the thermoplastic material can be melted and formed into the ends 104, 106, which simplifies the method of manufacturing the device 100. Simple devices such as soldering irons can be used to form the ends. Thermosetting plastics are generally held in place by an adhesive. Suitable polymers may include optimal biocompatible materials that can be made from fibers, but may include polyethylene terephthalate (PET), in particular thermoset plastics such as Teqron; Polyamides including nylon; Polyethylene, polypropylene, polybutylene, mixtures thereof, alloys, blocks and random copolymers; Polyglycolic acid; Fluoropolymers (polytetrafluoro-ethylene) or silk. Particular preference is given to fibrous PET (sold in microns) and polypropylene for long-term safe and efficient use in the body. Particularly preferred among them is polypropylene.

2A shows a partial cross section of one end of a coil 100 of the present invention. 2A also shows a helical wound outer coil 102 having an end 106 formed of previously melted fibers forming an extensible member 108. Ends of this type may be considered to have adequately higher vessel occlusion properties than metal ends. Another functional equivalent to this structure has an end portion 106 formed of epoxy and its equivalents, such as epoxy, which is in fact mechanical.

2B shows an outer handle 112 that fixes the length of the coil member 102 and prevents the coil member from stretching. 2C shows a reforming scalpel made of glue or pre-molded polymer having a diameter greater than the inner diameter of the coil 102 and preventing the coil from stretching. The handle 112 and block 114 are not shown but attached to the coil 102, but may be attached.

The modifications shown in FIGS. 1A, 1B, 1C, 2A, 2B and 2C are configured to be arranged by the use of pushers and catheter in the manner disclosed in the above-mentioned Richard et al. Patent. Other methods (and additional fixtures or joints to accomplish such methods) may also be used.

For example, the end of the device may house an electrically cutable joint of the type disclosed in U.S. Patent Nos. 5,354,295 and 5,122,136 to Googleriel and Seppetka. 3A and 3B show this variant in partial cross-sectional view. The blood vessel occlusion coils 130 and 230 are attached to the filling members 132 and 232. The filling members or bushings 132 and 232 include thermoplastics or epoxy formed in place, and bond the extension members 134 and 234 to the core wires 136 and 236. The extension members 134 and 234 are preferably attached directly to the vascular occlusion coils 130 and 230 via the filling member or bushings 132 and 232. In the present modification, the core wires 136 and 236 have enlargement members embedded in the filling members 132 and 232. The core wires 136, 236 are made of polytetrafluoroethylene except for the small sacrificial junctions 138, 238 which are intended as sites of electrolysis when the junctions 138, 238 are corroded or cut and the coils are placed into body parts. It is insulated with a perylene (polyperesylene) combination. Details of the variant are disclosed in US patent application Ser. No. 08 / 367,061, filed December 30, 1994 (without extension members 136, 236), the entire contents of which are incorporated herein by reference. .

3C shows a preferred variant of the device of the present invention. Assembly 131 uses an extension member 133 that is indirectly coupled to coil 135. In particular, the extensible member 133 is a thermoplastic fiber or fibers that are melted to form a coil tip 137 at one end of the coil 135, and the hook 139 at the other end of the coil 135 (or close). Form a ring shape around. The anchor coil 141 is coaxially positioned between the vessel occlusion coil 135 and the pusher wire 136. The hook 139 forms the final or half winding of the anchor coil 141. The extension member 133 is indirectly attached to the vascular occlusion coil 135 via the anchor conyl 141. The anchor coil 141 and the blood vessel occlusion coil 135 are preferably welded together.

3C shows the vascular occlusion coil 135 in its fully extended state. The extensible member 133 can withstand other axial stretching of the assembly. If the vessel occlusion coil 135 is not extended, it is evident that the extension member 133 is loosely, ie, typically longer than the lumen of the assembly 131. If the stretch resistant member 133 is unable to have loose axial pit, adjacent windings of the coil 135 leave a “bottom” relative to each other during passage through windings in the vasculature.

4A shows another variant of the junction for releasing the coil of the present invention to any part of the body. In this modification, the junction is mechanically arranged. The primary coil 140 has a locking ring, one ring 142 of the locking ring is located at the end of the coil 140 and the other ring 144 is located on the end of the pusher 146. . The wear resistant member 148 is attached to the lock ring 142 via the filler block 154. The filler block 154 is attached to the stretch resistant member 148. The coil assembly 150 formed of the primary coil 140, the locking ring 142, and the extension member 148 is disposed by contracting the catheter body (or sheath) 152. FIG. 4B illustrates a variation of the apparatus shown in FIG. 4A without using a particular filler block material 154 to attach to the stretch resistant member.

In addition, suitable mechanical arrangement joints for use with the coil of the present invention include the following.

US Pat. No. 5,234,437 to Seppetka, which discloses a method of unwinding a spiral winding coil from a pusher with a locking surface.

US Pat. No. 5,250,071 to Palermo, which discloses an embolic coil assembly using a locking ring mounted on a pusher and on an embolic coil.

US Patent No. 5,261,916 to Engelson, which discloses a detachable pusher / vessel closure coil assembly with locking ball and keyway coupling.

US Pat. No. 5,304,195 to Twifold et al. (With a wire extending to a fixed base with balls on the base) and a pusher having similar ends, the two ends being mutually fixed and from the distal tip of the catheter Initiates a pusher-vessel closure coil assembly that is detached when evacuated)

US Pat. No. 5,312,415 to Palermo, which discloses a method for separating multiple coils from a single pusher using a guidewire having a portion engageable with the inside of a spiral winding coil.

U.S. Pat.No. 5,350,397 to Palermo et al., Which discloses a pusher having a neck through the shaft at the end and the pusher. The pusher is fixed at the end of the embolic coil and axially with respect to the member wound on the proximal end of the vascular occlusion coil. Push the pusher wire that is positioned to remove it.)

All patents mentioned above are incorporated herein by reference.

As mentioned above, the apparatus of the present invention may take the simple linearity shown in FIGS. 1 and 2, or may take the shape that is not so simple. 5 to 7 show a shape called a secondary shape because it is formed from the primary coil in a simple operation of winding the primary coil in a shape having a predetermined shape and then heating the shape thus formed. 5 illustrates a C-shaped coil assembly 160 having an extension member 162. 6 shows a clover-type coil assembly 164 with an extension member 162. 7 shows a double loop coil assembly 166. It represents various secondary shapes suitable for the present invention.

In addition, the apparatus of the present invention may be used in connection with various external fiber additives. FIG. 8 is a partial side view illustrating a variation of the apparatus 170 of the present invention having a yarn material 172 wrapped in a loop through the coil 174. The attachment method is described in more detail in US Pat. Nos. 5,226,911 and 5,304,194 to Chi et al., The entire contents of which are incorporated herein by reference. Additional description of certain fiber attachments is disclosed in US patent application Ser. No. 08 / 265,188, filed June 24, 1994.

9 shows a partial ablation of the device 180 with the braided covering 182 of the fibrous material and the stretch resistant member 184. This coil closure method is described in more detail in US Pat. No. 5,382,259 to Phelps et al., The entire contents of which are incorporated herein by reference.

Fibrous woven or braided tubular materials are made from biocompatible materials such as dichron (polyester), polyglycolic acid, polylactic acid, fluoropolymer (polytetrafluoroethylene), nylon (polyamide) or silk May be The strands forming the braid are quite heavy and have a tensile strength greater than about 0.15 pounds, for example. The aforementioned materials may be melted or fused to the coil to the extent that they are thermoplastic. As a variant, it may be glued to the coil or otherwise fixed. Preferred material is Dacron.

Figure 10 illustrates a preferred assembly that embodies a number of desired embodiments of the present invention. In particular, the highly flexible variant of the vascular occlusion device of the present invention described above, that is, the vascular occlusion device may be provided with a drop of 20 ° or more and a polymeric extensible member contained therein, is a flow-oriented catheter, It is especially suitable for inclusion in the case of using a junction which can be cut by electrolysis. 10 illustrates a flow oriented catheter 200 including a highly flexible vascular occlusion coil 202 as described above and using a similar flexible stress resistant member 204. The flow oriented catheter 200 may be provided with a terminal radiopaque marker 206 if desired.

At the proximal end of the blood vessel occlusion coil 202, there is a coupling wire 208 installed at all points of the proximal end of the electrolytic junction 210.

Flow oriented catheter 200 may be a known design, such as described in US Pat. No. 5,336,205 to Jensen et al., The disclosure of which is incorporated herein. “Flow-directed catheters” are oriented through the vasculature to the treatment site in the body by the driving force of the original blood flow. The more terminal segments of the flow oriented catheter are often of material with significant elastic properties but can be of high burst strength, for example polyurethane, polyvinyl chloride, silicone, and the like. They are often free to spring. Thus, flow oriented catheter is not particularly suitable for use in guidewires or the like.

However, when using such a variant of the vascular occlusion device, the vascular occlusion device is complicated and can be introduced using hydraulic pressure (with salin) alone, so that they can be used as a flow orientation catheter. Furthermore, because the vessel occlusion device 202 includes an extensible member 204, the vessel occlusion device 202 may be retracted into the catheter 200 using the binding wire 208.

The bond wire 208 used therein must be very flexible so as not to interfere with the movement of the catheter 200. It is conductive and is located at the proximal end of the electrolytic junction 210. The introduction of a current into the bond wire 208 causes the electrolytic junction 210 to corrode and the vascular occlusion device 202 to detach. A complex description of such a device is described in U.S. Pat.Nos. 5,122,136 and 5,354,295 to Google Limite and Seppetka.

11A-11D illustrate a conventional deployment method for introducing the vascular occlusion device of the present invention described above. It will be appreciated that this method is quite different from that described in the above described patents of Ricardo. In particular, FIG. 11A shows the distal tip of the introduction catheter 310 disposed within the opening 212 of the aneurysm 314 found in the artery 316. The distal and end portions of the vascular occlusion device 318 are shown to be within the catheter 310. In FIG. 11B, the distal end of the vascular occlusion device 318 is released from the distal end of the catheter 310 and wound in a secondary shape in the aneurysm 314. FIG. 11C shows the completion of the formation of the secondary body in the aneurysm 314. FIG. 11D shows the vessel occlusion device 318 separated from the pusher and placed in the aneurysm 314, with the catheter retracted from the inlet of the aneurysm.

When the coil of the present invention is placed in an aneurysm or at another site, it may be necessary to move or even retrieve the coil. For example, in FIG. 11D, the coil may extend into the artery through the inlet 312 of the aneurysm. Occlusion will not be desired in the arteries. A device, such as the vascular occlusion snare disclosed in Rappe US Pat. No. 5,387,219, may then be used to grasp the exposed coil and move it, or to retrieve it from the body. The stretch resistant member of the present invention prevents the coil from stretching into a single strand of wire and increasing its length.

Modifications of embodiments of the invention for carrying out the invention, which will be apparent to designers of medical devices, in particular vascular occlusion devices, are intended to be within the scope of the following claims.

The present invention relates to a vascular occlusion device comprising a spiral winding coil formed by winding a wire with a first or primary helix to form an outer helical member having first and second ends. An extension member extending through the formed lumen has the effect of being fixedly attached to the coil directly or indirectly in at least two positions.

Claims (37)

A spiral wound outer primary coil having a first end and a second end and defining a lumen between the first end and the second end; And a stretchable member extending through said lumen and fixedly attached to said primary coil in at least two positions. The method of claim 1, And a deployment tip attached to at least one of the first end or the second end. The method of claim 2, The deployment tip includes a mechanically separable end suitable for attaching to and detaching from a pusher. The method of claim 2, And the deploying tip includes an electrolytically separable end adapted to be separated from the pusher by applying a current on the pusher. The method of claim 1, And the extensible member comprises at least one fiber. The method of claim 1, The renal member includes a plurality of fibers. The method of claim 1, And the stretchable member comprises a wire. The method of claim 1, And the extensible member comprises a spiral coil. The method of claim 1, The device is a vessel occlusion device having a secondary shape. The method of claim 1, And said spiral winding coil comprises a metal selected from the group consisting of platinum, palladium, rhodium, gold, tungsten and alloys thereof. The method of claim 10, And said spiral winding coil comprises an alloy of platinum and tungsten. The method of claim 1, And said spiral winding coil comprises an alloy selected from the group consisting of stainless steel and a superelastic alloy. The method of claim 12, The spiral winding coil is a vessel occluding device comprising a nickel-titanium superelastic alloy. The method of claim 1, A vascular occlusion device comprising a polymer containing a radiopaque filler. The method of claim 1, And an external fibrous material attached to said primary coil. The method of claim 1, And the extensible member comprises a polymer. The method of claim 16, And the extensible member comprises a thermoplastic material. The method of claim 17, And the thermoplastic material comprises polyethylene terephthalate. The method of claim 17, And the thermoplastic material comprises polypropylene. The method of claim 17, The thermoplastic material forming a cap positioned at at least one end of the primary coil. The method of claim 1, And the extensible member is attached to at least one end of the primary coil. The method of claim 20, The cap is a vessel occlusion device of the same diameter as the primary coil. The method of claim 20, And the thermoplastic material forms caps at both ends of the first coil. The method of claim 1, And the extensible member extends through the lumen and is indirectly attached to and secured to both the first end and the second end. The method of claim 1, And the extensible member extends through the lumen and is attached and fixed directly to at least one of the first and second ends. The method of claim 1, The renal member includes a ribbon. The method of claim 26, And the ribbon is a metal selected from the group consisting of platinum, palladium, rhodium, gold, tungsten and alloys thereof. The method of claim 26, And the ribbon comprises an alloy of platinum and tungsten. The method of claim 26, And said spirally wound coil comprises an alloy selected from the group consisting of stainless steel and a superelastic alloy. The method of claim 29, And the spirally wound coil includes a nickel-titanium superelastic alloy. The method of claim 1, And the extension member is loosened in the lumen of the spirally wound coil. The method of claim 1, And an anchor coil positioned coaxially within the lumen of the coil spirally wound at at least one end of the spirally wound coil. The method of claim 32, And the extension member is fixedly attached to the anchor coil. The method of claim 33, wherein And the extensible member is fixedly attached to a hook on the anchor coil. The method of claim 1, A spirally wound primary coil is flexible, such that the blood vessel occlusion device bends more than about 20 ° by 1 cm when kept horizontal. The method of claim 4, wherein The spirally wound primary coil is flexible such that the spirally wound primary coil is flexible such that 1 cm bends more than about 20 ° when kept horizontal. The method of claim 36, And a combination of flow-oriented catheter surrounding at least a portion of the spirally wound primary coil.