Surgery – Instruments – Internal pressure applicator
Reexamination Certificate
1999-05-25
2001-09-11
Recla, David O. (Department: 3731)
Surgery
Instruments
Internal pressure applicator
Reexamination Certificate
active
06287318
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a device for occluding a space within the body, and particularly, it is useful as a vaso-occlusive device. In particular, it typically comprises a metallic core or core member, and two polymeric conjuncts, often polymeric members, of differing thrombogenicity. Typically, the core member will comprise a metallic helically-wound coil and the first polymeric member and second polymeric member will be fibrous materials woven into a braid. These devices may be placed at the desired site within a mammal to facilitate the formation of an occlusion. The inventive device has been found to promote the formation of scar tissue, healing tissue, or neocapillaries in vascular occlusions made by the device.
BACKGROUND OF THE INVENTION
Occlusive devices used for the blocking of openings within the human body, particularly vaso-occlusive devices, are now well-known and widely accepted as specific treatments for a variety of maladies. Although we often discuss the invention herein as one dealing with the occlusion of blood vessel or aneurysm closure, the invention is not so limited and may be used in a variety of other sites in the human body, e.g., fallopian tubes, bile ducts, etc. All members of the class of vaso-occlusive devices are surgical implements that may be placed within the vasculature of the human body, typically by a catheter, either to block the flow of blood through the vessel making up that portion of the vasculature, or to fill an aneurysm which stems from such a vessel. One member of the class of widely used vaso-occlusive devices includes the helically wound wire coil. Fibers may be woven into or laid crosswise through the coil windings to provide an additional substrate for clot formation and tissue growth within the chosen site. Vaso-occlusive devices having such a structure are widely commercially available from, for instance, Target Therapeutics Inc.
One very early patent, U.S. Pat. No. 4,994,069, to Ritchart et al., describes such a vaso-occlusive coil. This vaso-occiusive device assumes a linear helical configuration when placed within a delivery catheter and a folded, convoluted configuration when relaxed after having been released from the delivery catheter. Ritchart et al. describes a number of secondary or relaxed configurations, each of which is suitable for a specific type of malady.
U.S. Pat. No. 5,226,911, to Chee et al., teaches a helical vaso-occlusive coil to which fibrous elements are attached in such a way that they will not be dislodged during use. The fibrous elements are placed on the coil to enhance the tendency of the coil assembly to cause clot formation and tissue growth.
U.S. Pat. No. 5,382,259, to Phelps et al., teaches a vaso-occlusive device having a braided covering produced of polymeric fibrous elements on the exterior of the device. A variety of biocompatible materials are shown as suitable for the braided exterior tubular member.
Although these patents and others describe vaso-occlusive devices having metallic substrates and fibrous additions, none of them show the combination of polymeric materials as described here nor their utility in promoting tissue growth. Specifically, none of the references discussed above suggest that the noted combination is able to produce neocapillary formation in the vasculature.
SUMMARY OF THE INVENTION
This invention is an occlusive device suitable for placement in an internal area of the human body. It may be, and preferably is, used in the vasculature either in the open lumen of an artery or vein, in a somewhat more quiescent area such as the interior of an aneurysm, or perhaps to close a fistula or similar structure such as an arterio-venous malformation (AVM). When used in the vasculature, the occlusive device of this invention has been found to facilitate the formation of neocapillaries, scar tissue, cellular growth, or healing tissue in the occlusion.
The device itself typically comprises three components. The first is a core element and typically is a helically-wound coil. Braids or multiple coils or their combinations are also suitable as the core element. The remaining two components are polymeric in nature. The first is a polymer, typically in a fibrous form, which is present in the inventive device quickly to form clots when placed in the vasculature.
The second polymeric component typically composed of a polymer which is degradable or dissolvable within the human body. Especially preferred is polyglycolic acid.
It is within the scope of this invention that the polymeric components are either separate, e.g., in filamentary or covering form, or in the form of a mixture or copolymer (block or random) of the two polymeric components.
The preferred structure comprises a helically-wound core member produced of platinum wire (or other biocompatible material). The two polymeric materials are preferably wound into a braid, placed on the exterior of the coil, and fastened (perhaps by gluing or heat shrinking or melting) at the ends of the braid onto the coil. It is not, however, believed that the physical structure of the device is critical but that the combination of a bulk core member and two different types of polymeric materials as outlined above is central to the invention.
REFERENCES:
patent: 4739768 (1988-04-01), Engelson
patent: 4994069 (1991-02-01), Ritchart et al.
patent: 5122136 (1992-06-01), Guglielmi
patent: 5226911 (1993-07-01), Chee et al.
patent: 5250071 (1993-10-01), Palermo et al.
patent: 5382259 (1995-01-01), Phelps et al.
patent: 5490859 (1996-02-01), Mische et al.
patent: 5522836 (1996-06-01), Palermo
patent: 5549624 (1996-08-01), Mirigian et al.
patent: 5700258 (1997-12-01), Mirigian et al.
patent: 5733294 (1998-03-01), Forber et al.
patent: 5743905 (1998-04-01), Eder et al.
patent: 5800454 (1998-09-01), Jacobsen et al.
patent: 5823198 (1998-10-01), Jones et al.
patent: 5855578 (1999-01-01), Gugliemi et al.
patent: 5891128 (1999-04-01), Gia et al.
patent: 5891130 (1999-04-01), Palermo et al.
patent: 5895385 (1999-04-01), Gugliemi et al.
patent: 5895391 (1999-04-01), Farnholtz
patent: 5911717 (1999-06-01), Jacobsen et al.
patent: 5916235 (1999-06-01), Gugliemi
patent: 5919187 (1999-07-01), Guglielmi et al.
patent: 5925037 (1999-07-01), Fober
patent: 5925060 (1999-07-01), Forber
patent: 5925062 (1999-07-01), Purdy
patent: 5927345 (1999-07-01), Samson
patent: 5928226 (1999-07-01), Gugliemi et al.
patent: 5944714 (1999-08-01), Gugliemi et al.
patent: 0778005 (1997-06-01), None
patent: WO 94/09705 (1994-05-01), None
patent: 94/10936 (1994-05-01), None
patent: 94/15534 (1994-07-01), None
patent: WO 95/20916 (1995-08-01), None
patent: WO 96/00035 (1996-01-01), None
patent: WO 97/48351 (1997-12-01), None
patent: WO 98/04198 (1998-02-01), None
patent: WO 98/04315 (1998-02-01), None
patent: WO 98/02100 (1998-02-01), None
Aganon Nestor
Villar Francisco S.
Ho (Jackie ) Tan-Uyen T.
Morrison & Foerster / LLP
Recla David O.
Target Therapeutics Inc.
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