This application relates generally to devices for treating aneurysms, and more specifically, to vaso-occlusive devices.
Vaso-occlusive devices are surgical implements or implants that are placed within the vasculature of the human body, typically via a catheter, either to block the flow of blood through a vessel making up that portion of the vasculature via the formation of an embolus or to form such an embolus within an aneurysm stemming from the vessel. One widely used vaso-occlusive device is provided in the form of a helical coil having “secondary shape” windings dimensioned to engage the walls of the vessels. Such vaso-occlusive coils are delivered out of a catheter to fill an aneurysm.
Applicants of the subject application determine that vaso-occlusive device formed using wire with larger outer diameter may be better for occupying the space of an aneurysm. However, using larger outer diameter wire to form the vaso-occlusive device may result in the vaso-occlusive device having too much stiffness, which may not be desirable for filling an aneurysm because the vaso-occlusive device may not be able to bend properly within the aneurysm.
In accordance with some embodiments, a vaso-occlusive device includes a coil comprising a helically wounded elongated member having a core and an outer layer, wherein the outer layer is made from a metal or alloy having a stiffness that is different from a stiffness of the core.
In accordance with other embodiments, a vaso-occlusive device includes first and second helical coils coupled to each other such that at least one loop of the first coil is between two adjacent loops of the second coil.
In accordance with still other embodiments, a vaso-occlusive device includes a first coil having a plurality of loops that define a lumen therethrough, and a second coil located within the lumen of the first coil, wherein each of the first and the second coils is made from a metal or an alloy.
Other and further aspects and features will be evident from reading the following detailed description of the embodiments.
The drawings illustrate the design and utility of embodiments, in which similar elements are referred to by common reference numerals. These drawings are not necessarily drawn to scale. In order to better appreciate how the above-recited and other advantages and objects are obtained, a more particular description of the embodiments will be rendered, which are illustrated in the accompanying drawings. These drawings depict only typical embodiments and are not therefore to be considered limiting of its scope.
Various embodiments are described hereinafter with reference to the figures. It should be noted that the figures are not drawn to scale and that elements of similar structures or functions are represented by like reference numerals throughout the figures. It should also be noted that the figures are only intended to facilitate the description of the embodiments. They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention. In addition, an illustrated embodiment needs not have all the aspects or advantages shown. An aspect or an advantage described in conjunction with a particular embodiment is not necessarily limited to that embodiment and can be practiced in any other embodiments even if not so illustrated.
It should be noted that the cross sectional dimension of the wire 14, and the sizes of the core 30 and outer layer 32 may be varied, depending on the requirements for a particular coil design. For example, if a stiffer coil 12 is desired, then the outer layer 32 may be made thicker while reducing the amount of material for the core 30 and keeping a constant cross sectional dimension for the wire 14. On the other hand, if a softer coil 12 is desired, then the core 30 may be made larger, while maintaining the same cross sectional dimension for the wire 14. In other embodiments, in addition to, or instead of, configuring the dimensions of the outer layer 32 and the core 30 to achieve a desirable stiffness for the coil 12, the materials for the core 30 and the outer layer 32 may be selected so that the desired stiffness for the coil 12 is achieved.
Also, it should be noted that any metallic materials may be used to form the core 30 and the outer layer 32 as long as they are biocompatible. In the above embodiments, the material for the core 30 is softer than the material for the outer layer 32. However, in other embodiments, the outer layer 32 may be made from a material that is softer (e.g., less stiff) than the material for the core 30. For example, in other embodiments, the outer layer 32 may be made from platinum, while the core 30 may be made from platinum-tungsten alloy, e.g., 8% tungsten and the remainder platinum.
In the illustrated embodiments, the first coil 12a and the second coil 12b may be made from different materials. For example, in some embodiments, the first coil 12a may be made from a metal, such as pure platinum, and the second coil 12b may be made from an alloy, such as platinum-tungsten alloy, e.g., 8% tungsten and the remainder platinum. The mechanical strength of pure platinum is about ⅓ of the platinum-tungsten alloy. Thus, forming part of the device 10 using a softer wire may provide a softer vaso-occlusive device 10 (e.g., for a given cross sectional dimension of the elongated member forming the coil 12a/12b). It should be noted that the first coil 12a is not limited to being formed from a metal, and that in other embodiments, the first coil 12a may be made from an alloy or a non-metallic material. Also, in other embodiments, the second coil 12b may not be an alloy, and may be made from a metal or a non-metallic material.
As shown in
In other embodiments, the core and the outer layer may be made from different materials. For example, the materials for the core and the outer layer described previously may be switched. In the illustrated embodiments, the wires 14a, 14b forming the respective coils 12a, 12b have the same cross-sectional dimension. In other embodiments, the wires 14a, 14b forming the respective coils 12a, 12b may have different cross-sectional dimensions, which may be selected to achieve a desired stiffness for the vaso-occlusive device 10.
In any of the embodiments described herein, the vaso-occlusive device 10 may have coil with different degrees of pitch along the length of the coil 12. For example, as shown in
In other embodiments, instead of having three sections with three different pitches, the vaso-occlusive device 10 may have more than three sections with more than three different pitches, or may have less than three sections with less than three different pitches. In further embodiments, the variability of the pitch along the length of the vaso-occlusive device 10 may be gradual.
It should be noted that the vaso-occlusive device 10 of
In further embodiments, the inner coil 12b may have a pitch that is more open that that of the outer coil 12a. For example, in other embodiments, the outer coil 12a may have a closed pitch, and the inner coil 12b may have an open pitch. Such configuration provides a vaso-occlusive device 10 that has a substantially continuous outer surface formed by the loops of the outer coil 12a.
In other embodiments, the first and second coils 12a, 12b in the devices 10 of
In further embodiments, the inner coil 12b may have a pitch that is more open that that of the outer coil 12a. For example, in other embodiments, the outer coil 12a may have a closed pitch, and the inner coil 12b may have an open pitch. Such configuration provides a vaso-occlusive device 10 that has a substantially continuous outer surface formed by the loops of the outer coil 12a.
Regarding the above-described embodiments of
Furthermore, while the above-described embodiments of
For example, the outer coil 12a may be embedded within the blunt tip 90 as that shown in the figure, or be directly attached to the blunt tip 90 using other mechanisms, such as a weld, glue, screw threads, or other suitable adhesive. In some embodiments, the inner coil 12b is secured to respective blunt tips at opposite ends of the inner coil 12b. The outer coil 12a may be secured to a blunt tip at one of the ends of the coil 12a, or to the respective blunt tips at both ends of the coil 12a. Securing the outer coil 12a to only one of the blunt tips (or to only one end of the inner coil 12b) has the advantage in that the outer coil 12a will be allowed to move more easily relative to the inner coil 12b, thereby providing a vaso-occlusive device 10 that is softer.
It should be noted that the materials for forming the coil(s) 12 of the vaso-occlusive device 10 should not be limited to the examples described previously. In any of the embodiments described herein, the material for the coil(s) 12 may be a radio-opaque material such as a metal or a polymer. Also, in other embodiments, the material for the coil(s) 12 may be rhodium, palladium, rhenium, as well as tungsten, gold, silver, tantalum, and alloys of these metals. These metals have significant radio-opacity and in their alloys may be tailored to accomplish an appropriate blend of flexibility and stiffness. They are also largely biologically inert. Also, any materials which maintain their shape despite being subjected to high stress may be used to construct the coil(s) 12.
For example, certain “super-elastic alloys” include various nickel/titanium alloys (48-58 atomic % nickel and optionally containing modest amounts of iron); copper/zinc alloys (38-42 weight % zinc); copper/zinc alloys containing 1-10 weight % of beryllium, silicon, tin, aluminum, or gallium; or nickel/aluminum alloys (36-38 atomic % aluminum), may be used. In further embodiments, titanium-nickel alloy known as “nitinol” may be used to form the coil(s) 12. These are very sturdy alloys which will tolerate significant flexing without deformation even when used as very small diameter wire.
In any of the embodiments described herein, the wire 14 used to form the coil may have a cross-sectional dimension that is in the range of 0.00002 and 0.006 inches. The coil 12 formed by the wire 14 may have a cross-sectional dimension between 0.003 and 0.025 inches. For neurovascular applications, the coil 12 diameter may be anywhere from 0.008 to 0.018 inches. In other embodiments, the wire 14 may have other cross-sectional dimensions, and the coil 12 may have other cross-sectional dimensions. In some embodiments, the wire 14 for forming the coil should have a sufficient diameter to provide a hoop strength to the resulting device 10 sufficient to hold the device 10 in place within the chosen body site, lumen or cavity, without substantially distending the wall of the site and without moving from the site as a result of the repetitive fluid pulsing found in the vascular system.
In any of the embodiments described herein, the axial length of the coil 12 may be in the range of 0.5 to 100 cm, and more preferably, in the range of 2.0 to 40 cm. Depending upon use, the coil 12 may have 10-75 turns per centimeter, or more preferably 10-40 turns per centimeter. In other embodiments, the coil 12 may have other lengths and/or other number of turns per centimeter.
In some embodiments, the vaso-occlusive devices 10 described herein may have the simple linear shape shown previously, or may have shapes which are more complex.
In any of the embodiments described herein, the vaso-occlusive device 10 may be delivered using a catheter.
In some embodiments, the distal portion of the catheter 200 may be made from any material, such as polyurethane, polyvinylchloride, silicones, or other polymers. The connective wire 208 used therein should be very flexible so that it does not interfere with the movement of the catheter 200. It is conductive and insulated proximally of the electrolytic joint 210. Introduction of an electric current into the connective wire 208 will cause the electrolytic joint 210 to erode and the vaso-occlusive device 10 to become detached. In the illustrated embodiments, the vaso-occlusive device 10 further includes a stretch-resisting member 204 for preventing over-stretching of the vaso-occlusive device 10. In other embodiments, the stretch-resisting member 204 is not needed.
It should be noted that the manner of releasing the vaso-occlusive device 10 from a delivery catheter is not limited to the example described, and that other ways of discharging vaso-occlusive devices into the human vasculature are possible. For example, in other embodiments, mechanically detachable devices may be used to detachably couple the vaso-occlusive device 10 to the pusher.
In some embodiments, the vaso-occlusive device 10 may be unscrewed from a pusher having interlocking surfaces. In other embodiments, interlocking clasps mounted both on the pusher and on the vaso-occlusive device 10 may be used to detachably couple the vaso-occlusive device 10 to the pusher. In other embodiments, an interlocking ball and keyway-type coupling may be used to detachably couple the vaso-occlusive device 10 from the pusher. In further embodiments, a pusher-vaso-occlusive coil assembly may have a proximally extending wire carrying a ball on its proximal end and a pusher having a similar end. The two ends are interlocked and disengage when expelled from the distal tip of the catheter.
In some embodiments, the vaso-occlusive device 10 may have a secondary shape. In such embodiments, while the vaso-occlusive device 10 is housed within the catheter 310, the vaso-occlusive device 10 is stretched into a low profile. When the vaso-occlusive device 10 is deployed out of the lumen of the catheter 310, the vaso-occlusive device 10 then assumes its relaxed configuration to have the secondary shape.
In
In some embodiments, the pusher merely abuts against the vaso-occlusive device 10. In such embodiments, as soon as the vaso-occlusive device 10 is deployed out of the lumen of the catheter 310, the vaso-occlusive device 10 is then separated from the pusher. In other embodiments, the vaso-occlusive device 10 may be mechanically coupled to the pusher. In such embodiments, the user may operate on the coupling mechanism to detach the vaso-occlusive device 10 from the pusher. For example, if the coupling mechanism includes an electrolytic joint, the user may apply energy to sever the joint, thereby releasing the vaso-occlusive device 10 from the pusher.
In any of the embodiments described herein, the vaso-occlusive device may further include fibrous elements coupled to the coil. For example, the fibrous elements may extend in a sinusoidal fashion down the length of the coil, and may be coupled to loops of the coil. The fibrous elements may enhance the ability of the coil to fill space within the vasculature and to facilitate formation of embolus and subsequent allied tissue. The fibrous materials may be made from biocompatible materials, such as Dacron (polyester), polyglycolic acid, polylactic acid, fluoropolymers (polytetrafluoroethylene), Nylon (polyamide), or silk. The strands forming the braid should be reasonably heavy, e.g., having tensile strength of greater than about 0.15 pounds. The materials mentioned, to the extent that they are thermoplastics, may be melted or fused to the coils. Alternatively, they may be glued or otherwise fastened to the coils. Preferred materials include Dacron.
Also, in any of the embodiments described herein, the vaso-occlusive device 10 may further include a stretch-resisting member coupled (e.g., soldered, brazed, glued, or otherwise fixedly attached) to both ends of the vaso-occlusive device 10 and extending through a central lumen of the vaso-occlusive device 10. The stretch-resisting member enhances the tensile strength of the vaso-occlusive device 10, and may prevent the vaso-occlusive device 10 from being over-stretched during use. In other embodiments, the stretch-resisting member may be coupled to the vaso-occlusive device 10 at one or more locations intermediate to the ends of the vaso-occlusive device 10. The stretch-resisting member may be thermoplastic or thermosetting and comprise a bundle of threads or a single filament melted onto, glued, or otherwise fixedly attached to the vaso-occlusive device 10. In some instances, it may also be desirable to include one or more metallic strands in the stretch-resisting member to provide stiffness or electrical conductance for specific applications.
Although particular embodiments have been shown and described, it will be understood that they are not intended to limit the present inventions, and it will be obvious to those skilled in the art that various changes and modifications may be made. The specification and drawings are, accordingly, to be regarded in an illustrative rather than restrictive sense. The various embodiments shown and described herein are intended to cover alternatives, modifications, and equivalents of the disclosed inventions, which may be included within the scope of the appended claims.
The present application claims the benefit under 35 U.S.C. §119 to U.S. provisional patent application Ser. No. 61/321,052, filed Apr. 5, 2010. The foregoing application is hereby incorporated by reference into the present application in its entirety.
Number | Date | Country | |
---|---|---|---|
61321052 | Apr 2010 | US |