Surgery – Instruments – Internal pressure applicator
Reexamination Certificate
1998-02-04
2001-11-27
Reip, David O. (Department: 3731)
Surgery
Instruments
Internal pressure applicator
C606S194000, C606S198000
Reexamination Certificate
active
06322576
ABSTRACT:
FIELD OF THE INVENTION
This invention is an implantable vaso-occlusive device. More particularly, it is a vaso-occlusive device which, in a relaxed configuration, has a stable three-dimensional structure which may be used to fill an anatomical cavity. The vaso-occlusion member may be one or more strands of a helical coil or braid variously comprising a suitable metal, or, in the case of a braid, such metal may be co-woven with various polymeric or natural fibers. The relaxed configurations are comprises of a series of overall shapes including spherical, elliptical, oval, clover or box-like. The relaxed configurations may be substantially hollow or may have one or more strands or loops of the coil passing though the interior of the structure. The device is a self-forming shape made from a pre-formed vaso-occlusion member.
BACKGROUND OF THE INVENTION
Vaso-occlusion 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 through 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 a helical wire coil having windings which may be dimensioned to engage the walls of the vessels. Other less stiff helically coiled devices have been described, as well as those involving woven braids.
For instance, U.S. Pat. No. 4,994,069, to Ritchart et al., describes a vaso-occlusive 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 (by its passage through the catheter) and the coil assumes a relaxed configuration—which is better suited to occlude the vessel—once the device is so placed. Ritchart et al. describes a variety of shapes. The secondary shapes of the disclosed coils include “flower” shapes and double vortices. A random shape is described, as well. U.S. Pat. No. 5,648,082 to Sung et al., describes methods for treating arrhythmia using coils which assume random configurations upon deployment from a catheter.
Other three dimensional vaso-occlusive coils have been described. U.S. Pat. No. 5,624,461 to Mariant describes a three-dimensional in-filling vaso-occlusive coil. U.S. Pat. No. 5,639,277 to Mariant et al. describe embolic coils having twisted helical shapes and U.S. Pat. No. 5,649,949 to Wallace et al. describes variable cross-section conical vaso-occlusive coils.
U.S. Pat. No. 5,334,210 to Gianturco, describes a vascular occlusion assembly comprising a foldable material occlusion bag and a filler member, for example, a helical coil with a J-hook on the proximal end. The bag expands to form a diamond shape structure and the filler member inside the bag is forced into a convoluted configuration as it advanced into the cavity of the foldable bag.
Implantable devices using variously shaped coils are shown in U.S. Pat. No. 5,537,338 to Purdy. Purdy describes a multi-element intravascular occlusion device in which shaped coils may be employed. U.S. Pat. No. 5,536,274 to Neuss shows a spiral implant which may assume a variety of secondary shapes. Some complex shapes can be formed by interconnecting two or more of the spiral-shaped implants.
Spherical shaped occlusive devices are described in U.S. Pat. No. 5,645,558 to Horton. Horton describes how one or more strands can be wound to form a substantially hollow spherical or ovoid shape when deployed in a vessel.
There are a variety of ways of discharging shaped coils and linear coils into the human vasculature. In addition to those patents which apparently describe only the physical pushing of a coil out into the vasculature (e.g., Ritchart et al.), there are a number of other ways to release the coil at a specifically chosen time and site. U.S. Pat. No. 5,354,295 and its parent, 5,122,136, both to Guglielmi et al., describe an electrolytically detachable embolic device.
A variety of mechanically detachable devices are also known. For instance, U.S. Pat. No. 5,234,437, to Sepetka, shows a method of unscrewing a helically wound coil from a pusher having interlocking surfaces. U.S. Pat. No. 5,250,071, to Palermo, shows an embolic coil assembly using interlocking clasps mounted both on the pusher and on the embolic coil. U.S. Pat. No. 5,261,916, to Engelson, shows a detachable pusher-vaso-occlusive coil assembly having an interlocking ball and keyway-type coupling. U.S. Pat. No. 5,304,195, to Twyford et al., shows a pusher-vaso-occlusive coil assembly having an affixed, proximately 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. U.S. Pat. No. 5,312,415, to Palermo, also shows a method for discharging numerous coils from a single pusher by use of a guidewire which has a section capable of interconnecting with the interior of the helically wound coil. U.S. Pat. No. 5,350,397, to Palermo et al., shows a pusher having a throat at its distal end and a pusher through its axis. The pusher sheath will hold onto the end of an embolic coil and will then be released upon pushing the axially placed pusher wire against the member found on the proximal end of the vaso-occlusive coil.
Vaso-occlusive coils having little or no inherent secondary shape have also been described. For instance, in U.S. patent application Ser. No. 07/978,320, filed Nov. 18, 1992, entitled “Ultrasoft Embolization Coils with Fluid-Like Properties” by Berenstein et al., is found a coil having little or no shape after introduction into the vascular space.
None of these devices are stable coil designs having complex three-dimensional winding patterns. The complex winding patterns can be formed using mandrels of various designs, including a single center post having one or more side pins, a center post having one or more top pins or other random patterns having shape breaks.
SUMMARY OF THE INVENTION
This invention is a vaso-occlusive device comprising one or more vaso-occlusive members which are wound to form complex winding patterns when relaxed. The vaso-occlusive member itself may be a helically wound coil or braid typically comprising a biocompatible metal. Fibrous materials may be woven into the member or tied or wrapped onto it. The stable coils of the invention are formed by first winding a wire into a first helix; the first helix is then wound into a secondary form which is wound back onto itself, for example on a mandrel, to form two or more layers of the primary coil. The reverse winding may be on the same axis as the first winding axis or may be on a different axis. The overall form may be selected to be a variety of shapes deployed, including generally spheroid, elliptical, clover or box shapes. Generally, the shape of the relaxed configuration is formed by the outermost loops of the primary coil having the largest diameter. Loops having smaller diameters pass through the relaxed configuration. Desirably, the vaso-occlusive device is of a size and shape suitable for fitting snugly within a vascular cavity (e.g., an aneurysm, or perhaps, near a fistula). The stiffness of the various parts of the coil may be selected to enhance the utility of the device for specific applications. Fibrous materials may be woven into the member or tied or wrapped onto it.
The device is used simply by temporarily straightening the device and introducing it into a suitable catheter, the catheter already having been situated so that its distal opening is within the mouth of the vascular cavity or opening to be filled. The device is then pushed through the catheter and, upon its ejection from the distal end of the catheter into the vascular cavity, assumes its relaxed shape. The relaxed configuration of a device deployed into the body may be different than a device deployed in the open, due to constraints of vessels and the like.
The device is typically used in the human vasculature to form
Chen Mary M.
Ho Liem
Hui Delilah Yin
Levine Marc-Alan
Wallace Michael P.
Morrison & Foerster / LLP
Reip David O.
Target Therapeutics Inc.
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