Aneurysm treatment device and method of use

The present application discloses an apparatus for treating vascular aneurysms and includes a radially expandable substantially cylindrical structure formed from a plurality of support members and defining a plurality of openings, and at least one reactive material strand selectively integrated into the substantially cylindrical structure. The reactive material is configured to assume a non-reacted state and a reacted state. The reactive material in the reacted state is configured to restrict a flow of blood to an aneurysm.

BACKGROUND

Generally, the mammalian circulatory system is comprised of a heart, which acts as a pump, and a system of blood vessels which transport the blood to various points in the body. Due to the force exerted by the flowing blood on the blood vessel the blood vessels may develop a variety of vascular disabilities or dysfunctions. One common vascular dysfunction known as an aneurysm results from the abnormal widening of the blood vessel. Typically, vascular aneurysms are formed as a result of the weakening of the wall of a blood vessel and subsequent ballooning of the vessel wall. As shown inFIG. 1, the aneurysm10often comprises a narrow neck portion12which is in communication with the blood vessel14and a dome portion16in communication with the neck portion12. As shown inFIG. 1the neck portion12and the dome portion16form a cavity18. Aneurysms have been known to form in a plurality of location though the body, including, for example, the brain, the abdomen, and throughout the circulatory system.

In response, several surgical techniques for treating aneurysms have been developed. Initially, an aneurysmectomy was required to repair the dysfunctional tissue. The aneurysmectomy procedure requires the surgeon to gain access to the aneurysm, excise the aneurysm, and replace the void with a prosthetic graft. Because this is a major surgical undertaking, the mortality rate of the procedure is relatively high. Commonly, the aneurysmectomy procedure is unavailable to patients with severe coronary or cerebral arteriosclerosis, severe restrictive pulmonary disease, and significant renal disease or other complicating factors. An alternate method of treating cerebral aneurysms called ‘microsurgical clipping’ requires the placement of a metallic clip across the neck of the aneurysm, thereby excluding the aneurysm from the blood flow.

In response to the shortcomings of the aneurysmectomy and the microsurgical clipping procedures, less invasive methods of treatment have been developed. Commonly, these procedures require the formation of an artificial vaso-occlusion, which is obtained by implanting a number of devices or suitable materials into the cavity18of the aneurysm, thereby resulting in a decrease in the flow of blood into the aneurysm. The reduced flow results in hemostasis and the formation of a clot. Generally, this procedure requires the surgeon to advance a micro-catheter to a location inside the aneurysm and deposit a biologically-compatible vaso-occlusive material or device therein. Typical vaso-occlusive devices and materials include platinum micro-coils, hog hair, microfibrillar collagen, various polymeric agents, material suspensions, and other space filling materials.

FIG. 2shows an aneurysm10formed on a blood vessel14, the aneurysm10having a vaso-occlusive device20positioned within the aneurysm dome18. A disadvantage of filling an aneurysm with devices is that the vaso-occlusive mass may impinge on nerves or other biological structures, thereby resulting in adverse biological symptoms. For example, the impingement of the vaso-occlusive device20on structures or nerves within the brain, commonly known as ‘mass effect’, may result in adverse neurological symptoms. Another problem associated with vaso-occlusive devices is maintaining the device within the aneurysm. Blood flow through an otherwise functional blood vessel may be compromised should the device migrate from the aneurysm during or following implantation, thereby possibly resulting in a vascular embolism.

An alternate method of repairing an aneurysm has been developed which requires the implantation of a mechanical support device within the blood vessel near the neck portion of the aneurysm. Generally, these mechanical support devices, commonly referred to as “stents”, comprise deployable mechanical support structures capable of delivery to a situs within the blood vessel through catheters. In addition to providing mechanical support to the dysfunctional vessel wall, the stent may include a mechanical structure which seeks to restrict the blood flow though the portion of the blood vessel proximate the aneurysm, thereby reducing or eliminating the aneurysm. Exemplary mechanical structures capable of restricting blood flow to an aneurysm include meshes or fenestrated structures which are positioned near an aneurysm10and restrict the flow of blood thereto.

FIG. 3shows a stent22positioned in a blood vessel14proximal to an aneurysm10. While a stent may provide adequate mechanical support to the blood vessel, these devices have demonstrated limited effectiveness in limiting blood flow to the aneurysm. As such, the aneurysm typically remains intact and may increase in size. In response, stents may be covered with various coatings designed to limit blood flow to the aneurysm. These coatings typically include biologically compatible polymers, films, and fabrics. However, the application of these coatings to the stents increases the cross-sectional diameter of the device, thereby resulting in a high profile stent-graft. As a result, the blood flow through the blood vessel is reduced by the presence of a high profile stent-graft. In addition, device profile is a significant problem for the treatment of cerebral aneurysms due to the small size of the cerebral blood vessels, therefore requiring the device to be deliverable to the aneurysm through a micro-catheter. As such, high profile stent-grafts are typically not used in the treatment of cerebral aneurysms.

Thus, there is presently an ongoing need for a device and method for effectively treating aneurysms without significantly affecting blood flow through the blood vessel.

SUMMARY

The aneurysm treatment devices of the present application effectively occlude or inhibits blood flow to an aneurysm without substantially impairing blood flow through the blood vessel. In addition, the aneurysm treatment devices of the present application are capable of being applied to a variety of aneurysms formed on blood vessels throughout the body.

In one embodiment, the aneurysm treatment device of the present invention comprises at least one support member and reactive material selectively applied to the support member. The at least one support member, which has at least a first surface capable of receiving the reactive material, provides a substrate for receiving the reactive material. Alternatively, the at least one support member may also provide support to weakened vascular tissue. The reactive material has a non-reacted state and a reacted state. In a reacted stated the reactive material, as selectively applied to the at least one support member, is capable of restricting or occluding the flow of blood to the aneurysm. In an alternate embodiment, the at least one support member may be manufactured from or otherwise incorporate reactive material therein. The device is preferably controllably released from an elongate delivery apparatus. The release mechanism may be any of the vaso-occlusive device and stent detachment means known in the art including but not limited to mechanical, electrolytic, electromechanical, thermal, hydraulic, and shape-memory means.

In an alternate embodiment, the present invention is directed to a vascular patch comprising a radially and axially flexible patch body formed by a plurality of interlocking support members. The interlocking support members, which are capable of supporting vascular tissue, form a plurality of fenestrations. A reactive material capable of restricting or occluding the flow of blood to an aneurysm is selectively applied to, woven into, integral to, or otherwise incorporated into the interlocking support member. For example, the interlocking member may be manufactured from fibrous or formed reactive material

In yet another embodiment, the present invention is directed to a coiled bridge device comprising radially and axially flexible resilient sinusoidal body member which defines a plurality of openings. The sinusoidal body member has a first radius of curvature R and a second radius of curvature R′, wherein R′ is larger than R. The sinusoidal body member is formed by at least one support member and has a reactive material capable of restricting or occluding the flow of blood to an aneurysm, selectively applied thereto.

In another embodiment, the present invention is directed to a helical stent having a radially and axially flexible cylindrical body member positioned between a first end and a second end. The cylindrical body member, which is formed by at least one support member capable of supporting vascular tissue, defines an internal lumen which is in communication with the first and second ends. A reactive material capable of restricting or occluding the flow of blood to an aneurysm is selectively applied to the at least one support member.

In yet another embodiment, the present invention is directed to a helical stent having a radially and axially flexible cylindrical body member positioned between a first end and a second end. The cylindrical body member, which is formed by at least one support member capable of supporting vascular tissue, defines an internal lumen which is in communication with the first and second ends. A reactive material capable of restricting or occluding the flow of blood to an aneurysm is selectively applied to the at least one support member.

In another embodiment, the present invention is directed to a reticulated expandable stent comprising radially and axially flexible cylindrical body member positioned between a first end and a second end. The cylindrical body member, which is formed by at least one support member capable of supporting vascular tissue, defines an internal lumen which is in communication with the first and second ends. A reactive material capable of restricting or occluding the flow of blood to an aneurysm is selectively applied to the at least one support member.

In still another embodiment, the present invention is directed to a bifurcated vascular support device comprising a bifurcated body member positioned between a first end, a second end, and a third end. The bifurcated body member further defines an internal lumen which communicates with the first, second, and third ends. The bifurcated body member is formed by at least one support member capable of supporting vascular tissue. A reactive material capable of restricting or occluding the flow of blood to an aneurysm is selectively applied to the at least one support member.

In another embodiment, the present invention is directed to an intra-aneurysmal bridge device comprising a flexible bridge body in communication with at least two engagement members. The at least two engagement members cooperatively form a joint. A reactive material capable of restricting or occluding the flow of blood to an aneurysm is selectively applied to the at least two engagement members.

The present invention also discloses a novel method of treating a vascular aneurysm. More particularly, the novel method of treating vascular aneurysms comprises the steps of providing a device for treating vascular aneurysms having a reactive material applied thereto, delivering the device to a vascular aneurysm, supporting the tissue near the aneurysm with the device, and allowing the reactive material to react thereby permitting the flow of blood through the blood vessel while restricting or occluding the flow of blood to the aneurysm

In yet another embodiment, the present application discloses an apparatus for treating vascular aneurysms and includes a radially expandable structure formed from at least one support member and defining a plurality of openings, and at least one reactive material selectively applied to a portion of the at least one support member. The reactive material is configured to assume a reacted state which restricts the flow of blood to an aneurysm.

In another embodiment, the present application discloses an apparatus for treating aneurysms and includes at least one support member defining an expandable support body, at least one reactive material selectively applied to at least one support member and having a non-reacted state and a reacted state. The support member has a diameter D in a non-reacted state and a diameter D′ in a reacted state, wherein diameter D′ is larger than diameter D.

In another embodiment, the present application is directed to an apparatus for treating vascular aneurysms and includes an occlusive support defined by one or more support members and having a first end and a second end and a lumen formed therein, one or more fenestrations formed on the occlusive support and configured to permit blood to flow therethrough, an end cap secured to the second end and configured to restrict the flow of blood therethrough.

The present application further discloses a method of treating a vascular aneurysm and includes providing a device having a reactive material selectively applied to at least one support member, delivering the device to a position in a blood vessel proximate a vascular aneurysm, expanding the device to approximately a diameter of a blood vessel, and activating the reactive material disposed on the device to reduce the flow of blood into the aneurysm.

In another embodiment, the present application discloses a method of treating a vascular aneurysm and includes providing a device having at least one support member and an end cap secured to the support member, delivering the device to a position in a blood vessel proximate a vascular aneurysm, expanding the device to approximately the diameter of the blood vessel, and reducing a flow of blood to the aneurysm with the end cap while permitting blood flow through the blood vessel.

In another embodiment, the present application discloses a method of treating a vascular aneurysm and includes providing a device having at least one support member and an end cap secured to the support member, delivering the device to a position in a blood vessel proximate a vascular aneurysm, expanding the device to approximately the diameter of the blood vessel, delivering a catheter through the blood vessel to a position proximate to the vascular aneurysm, inserting a space occupying material into the aneurysm, and maintaining the space occupying material within the aneurysm with the end cap to reduce the flow of blood into the aneurysm.

In another embodiment, the present application discloses a method of treating a vascular aneurysm and includes providing a device having at least one support member and an end cap secured to the support member, the end cap having a reactive material disposed thereon, delivering the device to a position in the blood vessel proximate a vascular aneurysm, expanding the device to approximately a diameter of a blood vessel, delivering a catheter through the blood vessel to a position proximate to the vascular aneurysm, inserting a space occupying material into the aneurysm, and activating the reactive material to maintain the space occupying material within the aneurysm with the end cap to reduce the flow of blood into the aneurysm.

Other objects and further features of the aneurysm treatment device of the present application will become apparent from the following detailed description when read in conjunction with the attached drawings.

DETAILED DESCRIPTION

Disclosed herein is a detailed description of various illustrated embodiments of the invention. This description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the invention. The section titles and overall organization of the present detailed description are for the purpose of convenience only and are not intended to limit the present invention.

The aneurysm treatment devices of the present application are generally used to restrict the ability of blood flowing through a blood vessel from entering an aneurysm formed thereon or to otherwise limit the amount of blood within an aneyrysm. The devices disclosed herein may be applied to a blood vessel in a variety of ways, including, without limitation, conventional surgical techniques and minimally invasive surgical techniques utilizing catheters of various sizes, balloon catheters, micro-catheters, and other ways generally known in the art of minimally invasive surgery. The aneurysm treatment devices disclosed herein may be used to repair a variety of aneurysms at various locations throughout the body. For example, in one embodiment these devices may be used in procedures to repair or otherwise treat cerebrovascular aneurysms.

The devices and methods of the present application have particular compatibility with the materials and methods of manufacture and use disclosed in co-pending U.S. patent application Ser. No. 09/804,935 filed on Mar. 13, 2001, entitled “Hydrogels That Undergo Volumetric Expansion In Response To Changes In Their Environment And Their Methods Of Manufacture And Use,” and co-pending U.S. patent application Ser. No. 09/909,715 filed on Jul. 20, 2001, entitled “Aneurysm Treatment Devices and Methods of Use,” each of which has been assigned to the assignee of the present application and which are incorporated by reference as if set forth herein in their entirety. Those skilled in the art will appreciate that the present invention may be manufactured with one or more of a variety of alternate reactive materials applied thereto, including, for example, collagen-polymer conjugate materials, photopolymerizable biodegradable materials, and other biodegradable cross-linked hydrogels known in the art.

Aneurysms form as a result of outward pressure applied to a diseased or damaged blood vessel wall by blood flowing within the vessel, thereby resulting in a weakened section of tissue ballooning outwardly from a blood vessel.FIG. 1shows an aneurysm10comprising a neck portion12in communication with a blood vessel14and having a dome portion16defining aneurysm cavity18. Those skilled in the art will appreciateFIG. 1illustrates an exemplary vascular aneurysm and is not intended to limit the scope or intent of the present invention.

One method of treating an aneurysm requires the formation of an embolism proximate to or within the aneurysm, thereby restricting or depriving the aneurysm of blood flow and reducing the likelihood the aneurysm will rupture.FIGS. 2 and 3show prior art devices used to repair aneurysms by artificially creating embolisms within or proximate to the aneurysm. InFIGS. 2 and 3the reference numerals10,12,14,16, and18have analogous meanings to the reference numerals identifying the features ofFIG. 1.FIG. 2shows an aneurysm10in communication with a blood vessel14. As shown, a vaso-occlusive device20is positioned within the aneurysm cavity18. Typically, a micro-catheter or other device is used to inject or otherwise insert the vaso-occlusive device20into the aneurysm cavity18, thereby decreasing the volume of the aneurysm capable of receiving blood from the blood vessel14.FIG. 3shows another device useful in treating aneurysms. As shown inFIG. 3, a stent22is positioned within a blood vessel14proximate to an aneurysm10. A stent22is a mechanical scaffold used to provide support to otherwise incompetent or weakened tissue or to or maintain the patency of a narrowed or occluded blood vessel.

The present application discloses various embodiments of devices useful for the embolization or isolation of aneurysms. More particularly, the present application discloses various structures capable of implantation within an aneurysm or configured to be inserted into a blood vessel proximate to an aneurysm. Exemplary aneurysm treatment devices disclosed herein include, without limitation, neck bridges, vascular patches, stents, and intra-aneurysmal implants. In one embodiment, an aneurysm treatment device may include a series of interlocking or otherwise connected support members forming a predetermined shape. In an alternate embodiment, the aneurysm treatment device comprises an implant body which may be partially or completely inserted into an aneurysm formed on a blood vessel. The implant body may form a predetermined shape or, in the alternative, may form a random shape.

FIGS. 4 and 5ashow cross sectional views of a portion of a support member24as used in the formation of a number of embodiments of the aneurysm treatment device of the present application before and following implantation. As shown inFIG. 4, the support member24may comprise a device substrate26having a reactive coating or material28applied to the exterior portion thereof prior to implantation. The support member24having a non-reacted reactive coating thereon has a first diameter of D.FIG. 5ashows reactive coating28disposed on the support member24in a reacted state, wherein the reactive coating28has expanded outwardly from the device substrate26in a preferential direction. As shown, in a reacted state the support member24assumes a second diameter of D′, wherein the second diameter D′ is larger than the first diameter D. For example, in one embodiment the second diameter D′ is about 20% larger than the first diameter D. In the illustrated embodiment, the reactive coating28has expanded more along the horizontal axis than the vertical axis. This permits the coating to inhibit flow outwardly through the device in the radial direction while minimizing its impact on longitudinal flow through the device and also minimizing the coating's impact on the overall profile of the device.

FIGS. 5band5cshow an alternate embodiment of an aneurysm treatment device comprising a reactive material strand or wrap positioned on a support member24. A number of support members24are interwoven thereby forming an interwoven structure27. Reactive material or strands28may applied to a support member24or positioned within the interwoven structure27in a radial, axial, or radially and axial orientation. For example, a support member24may be wrapped with a reactive material strand28. In an alternate embodiment, a reactive strand28may be disposed within the interwoven structure27. Optionally, a reactive strand28may be interwoven within the structure27.FIG. 5bshows an embodiment of the aneurysm treatment device with the reactive material28in a non-reacted state. As shown inFIG. 5b, the orifices29formed by the reactive material strand28and surrounding support members24have a first area of A.FIG. 5cshows the material strands28of the aneurysm treatment device in a reacted state wherein the orifices29formed by the reactive material strand28and surrounding support members24have a second area of A′. As shown, the second area A′ of the orifices29in a reacted state is less than the first area A of the orifices in a non-reacted state, thereby limiting the flow therethrough. For example, the second area A′ of the orifices29in a reacted state is at least about 20% less then the first area A of the orifices in a non-reacted state.

Referring again toFIGS. 4 and 5a, the support members24of the various embodiment of the aneurysm treatment device may be manufactured from a plurality of biologically-compatible materials. For example, in one embodiment at least one support member24is manufactured from materials including, without limitation, platinum, gold, tantalum, titanium, stainless steel, tungsten, Nitinol, shape memory alloys, formed reactive material, or other suitable material. Optionally, at least one support member24may be manufactured from a variety of biologically-compatible polymer materials, including, but not limited to, polyurethane, polyvinyl alcohol, polyester, polytetrafluoroethylene, silicone, acrylic, or similar polymeric materials. At least one support member24may incorporate radio-opaque or echogenic materials or agents, thereby enabling the surgeon to precisely position the device within an aneurysm, blood vessel, or other hollow organ.

At least one support member24used in forming an aneurysm treatment device includes at least one reactive material28applied thereto. The reactive material28may be applied in a variety of ways known in the art. For example, one or more support members24may be coated with a reactive material28. In an alternate embodiment, one or more support members24may have a reactive material28selectively applied thereto. For example, a reactive material28may be wrapped around or adhesively bonded to a portion of a support member24.FIGS. 5d-5eshow various embodiments of an aneurysm treatment device having a reactive fiber strand28applied thereto. As shown, the aneurysm treatment device comprises a support member24defining an internal passage25. A portion of the support member24includes a reactive fiber stand28encircling a portion of the support member24. In one embodiment, the reactive fiber strand may be adhesively coupled to the support member24. For example, a fiber substrate having an adhesive applied to one surface and a reactive material28applied thereto may be positioned on or selectively applied to one or more support members24.

The support member24receiving the reactive material strand28may have a constant or variable diameter or tangential width. For example,FIGS. 5fand5gshow an embodiment of a support member24′ having a variable tangential width. As such, the diameter of the support member24′ having the reactive material wrap28applied thereto is approximately equal to the diameter of surrounding support members24. As a result, the diameter of the aneurysm treatment device in a non-reacted state remains substantially constant. In one embodiment, the reactive material wrap28is closely wound about the support member24′. In an alternate embodiment, the reactive material wrap28may be intermittently applied to the support member24′.

Optionally, at least one support member24and/or the reactive material28applied to the support member24may include one or more therapeutic agents applied thereto. Exemplary therapeutic agents include, for example, embolizing factors, anti-embolizing factors, and anti-restenotic compounds. For example, the reactive material28applied to one or more support members24may be chemically doped or impregnated with a drug, compound, and/or endothelial cell assays to promote endothelial cellular adhesion. An exemplary coating is described in U.S. Patent Application Publication No. 2002/0049495 to Kutryk et al. which is incorporated in its entirety by this reference. In an alternate embodiment, the reactive material28applied to one or more support members24may be chemically doped or impregnated with a drug or compound to promote tissue growth or impart other therapeutic benefit about the support member24.

The reactive material28may be fabricated from a plurality of materials capable of expanding or volumetrically changing over time within the presence of blood or other fluid. For example, the Applicant's co-pending U.S. patent application Ser. No. 09/804,935 filed on Mar. 13, 2001 entitled “Hydrogels That Undergo Volumetric Expansion In Response To Changes In Their Environment And Their Methods Of Manufacture And Use” discloses a hydrogel useful as a reactive coating or material28for treating aneurysms. The above-referenced hydrogel comprises 1.25 g (0.021 moles) acrylamide, 0.87 g (0.009 moles) sodium acrylate, 0.005 g (0.00003 moles) N,N-methylenebisacrylamide, 7.95 g water, and 4.5 g sodium chloride (<10 micron particle size) added to an amber jar. The initiators, 53 microliters of N,N,N′,N-tetramethylethylenediamine and 65 microliters of 20% w/w ammonium persulfate in water, are added and the solution is aspirated into a 3-cc syringe. The solution is then injected into 0.025″ ID tubing and allowed to polymerize for 2 hours. The tubing is cut into 2-inch sections and dried in a vacuum oven. The dried hydrogel is washed 3 times in distilled water for 10-12 hours, 2 hours, and two hours, respectively, to remove porosigen, any unreacted monomer and any unincorporated monomers. The hydrogel may then be cut into sections of approximately 0.100 inch length called “pellets” and skewered with a platinum coil/wire assembly. In the alternative, the hydrogel may be drawn or formed into fibrous strands or portions of similar size and dimension as the support members24. These pellets or strands are then hydrated in alcohol and dried under vacuum at approximately 55 C for about 2 hours.

Thereafter, the dried pellets or strands are then placed in 50% hydrochloric acid/50% water and incubated for about 70 hours at 37 C. After the incubation, the excess hydrochloric acid solution is rinsed off of the pellets or strands with consecutive rinses of a) 70% isopropyl alcohol: 30% water for about 5 minutes, b) 100% isopropyl alcohol for about 15 minutes, c) 100% isopropyl for about 15 minutes and d) 100% isopropyl alcohol for about 15 minutes. The hydrogel pellets or strands are then dried under vacuum at 55 C for at least 2 hours. Prior to or following the complete drying process, the pellets or strands may be selectively applied to the at least one support member24as desired in a plurality of ways. In one embodiment the reactive material28is applied to the entire surface of a support member24. For example, the reactive material28may be maintained in a liquid form and a support member24may be submerged therein, thereby coating the entire surface of the support member24. In an alternate embodiment, the reactive material28is selectively applied to a portion of the support member24. For example, the reactive material28may be selectively applied to the portion of a support member24which will engage a wall of a blood vessel. Optionally, a strand of the reactive material28may be wound about or around a support member24. In another embodiment, the reactive material28may be applied to a substrate having a biologically compatible adhesive applied thereto. Thereafter, the substrate may be adhered to a support member24thereby applying the reactive material28thereto.

Once implanted in vivo, the reactive material28of the present embodiment becomes fully swollen after approximately one hour at physiological pH (about 7.4). For example, in one embodiment the reactive material28positioned on the support member24from a diameter of about 0.026 inch to a diameter of about 0.035 inch. As such, the cross sectional diameter of the support member24having reacted reactive material28thereon is about 25% larger than the cross sectional diameter of the support member24having non-reacted reactive material28thereon. Alternatively, the strands of reactive material28may be woven or integrated into the support structure. Optionally, the support structure24may be manufactured from a reactive material28without a substrate26. (SeeFIG. 4)

FIGS. 6-9show an embodiment of an aneurysm treatment device useful in isolating an aneurysm from a blood vessel. As shown inFIG. 6, the aneurysm treatment device comprises a vascular patch device30having a body member32formed by a plurality of interwoven or otherwise joined support members24axially displaced in relation to each other and capable of supporting weakened vascular tissue. The interwoven support members24form a plurality of fenestrations34. InFIGS. 6-8, a reactive material35is selectively applied to the interwoven support members24. As illustrated, the present embodiment permits the isolation and embolization of an aneurysm formed on a blood vessel without substantially occluding blood flow therethrough. As shown inFIG. 7, the vascular patch device30is formed by the plurality of support members24and may have an arcuate profile36. In one embodiment, the arcuate profile36may be selected to approximate the radius of curvature of the receiving blood vessel, thereby further limiting blood vessel occlusion following implantation. The vascular patch device30may be manufactured in a variety of sizes, lengths, and radiuses. For example, the vascular patch device30may approximate 270 degrees of the receiving blood vessel, thereby using mechanical force to secure the device within the blood vessel. If desired, the vascular patch device30may incorporate malleable support members24, thereby permitting the surgeon to adjust the arcuate profile36to conform to the radius of curvature of the receiving blood vessel during implantation.

Referring toFIG. 8, a vascular patch device30is shown positioned within a blood vessel14proximate to an aneurysm10, wherein the device30traverses the opening38to the aneurysm cavity18formed by the neck portion12. As shown, the expansion of the reactive coating35results in a decrease in the size of the fenestrations34formed in the vascular patch device30, thereby reducing the amount of blood entering the aneurysm. In an alternate embodiment, the device30may include a plurality of attachment devices (not shown) to assist in implanting and securing the device within a blood vessel. The attachment devices may include, for example, hooks, barbs, or similar devices manufactured from a plurality of materials, such as platinum, gold, tantalum, titanium, stainless steel, Nitinol, or other suitable material. In an alternate embodiment, the vascular patch device30may incorporate alternate attachment mechanisms, including, without limitation, adhesive materials, mechanical attachment mechanisms, or vacuum attachment mechanisms.FIG. 9shows a cross sectional view of a blood vessel14having the vascular patch device30positioned proximate to an aneurysm10. Those skilled in the will appreciate the present embodiment may be manufactured in a plurality of sizes, thereby enabling usage in various blood vessels to repair a plurality of aneurysms.

FIGS. 10-12show an alternate embodiment of an aneurysm treatment device useful in treating aneurysms. As shown inFIG. 10, the aneurysm treatment device includes a resilient coiled bridge device40having a sinusoidal body member42defining a plurality of openings44. The body member42may be formed along an arc46, thereby aiding in the implantation of the device while limiting the occlusion of blood vessel. The resilient body member42may be compressed along the line48to enable delivery and positioning of the coiled bridge device40in vivo. Upon placement of the coiled bridge device40the resiliency of body member42exerts an outward pressure along line50, wherein the resilient body member42engages the blood vessel wall (not shown). In an alternate embodiment, the coiled bridge device40may be used to provide mechanical support to weakened vascular tissue. As shown inFIG. 10, the body member42is coated with or otherwise disposes a reactive coating, thereby occluding or otherwise inhibiting the flow of blood to the aneurysm.FIG. 11shows an alternate embodiment of the coiled bridge device40comprising a resilient sinusoidal body member42having at least one reactive section52disposed thereon, and defining a plurality of openings44. The reactive portions52are areas selectively coated or otherwise incorporating a reactive material as defined above. The present embodiment permits the embolization of the aneurysm while limiting the occlusion within the blood vessel.FIG. 12shows a cross sectional view of an aneurysm treatment device positioned within a blood vessel14wherein the at least one reactive section52occludes or inhibits blood flow to an aneurysm10.

FIGS. 13-15show yet another embodiment of an aneurysm treatment device useful in treating aneurysms formed on weakened vascular tissue.FIGS. 13-15show various implantable expandable intraluminal prosthetic devices commonly referred to as “stents” capable of embolizing or isolating an aneurysm formed on weakened blood vessel tissue. In an alternate embodiment, the intraluminal vascular prosthetic devices may be used to provide mechanical support to weakened vascular tissue. As shown inFIG. 13, a helical expandable stent54comprises a cylindrical body member60disposed between a first end56and a second end58. The cylindrical body member60defines a central lumen62co-axially aligned with the longitudinal axis64of the stent54. The helical expandable stent54has a first diameter, D, thereby enabling insertion and positioning of the device within a blood vessel, and a larger second diameter, D′, which is capable of engaging and supporting a blood vessel wall. As shown, a reactive material66is selectively applied to the external surface of the helical expandable stent54.FIG. 14shows an alternate embodiment of the helical expandable stent54, comprising a cylindrical body member60having a first end56and a second end58. The cylindrical body member60further comprises at least one reactive section66disposed thereon, thereby enabling the embolization or isolation of an aneurysm while limiting blood vessel occlusion.FIG. 15shows cross sectional view of the present embodiment positioned within a blood vessel14, wherein the at least one reactive section66occludes or otherwise inhibits blood flow to an aneurysm10.

In another embodiment,FIGS. 16-18show various embodiments of reticulated expandable intraluminal stents. As shown inFIGS. 16 and 17, the reticulated stent68comprises a first end70and a second end72, having a cylindrical reticulated body74positioned therebetween. The cylindrical reticulated body74, which is comprised of a series of interconnected support members24, defines a flow lumen76co-axially aligned along the longitudinal axis78of the stent68having a first compacted diameter D, and a second larger diameter D′. As shown inFIGS. 16-18, a reactive material may be applied to the external portion of the stent68. Alternatively, the reactive material may be applied to selected areas or individual support members24may be manufactured from reactive material or otherwise incorporated therein.FIG. 18shows an embodiment of the reticulated expandable stent68positioned within a blood vessel14, wherein a reactive section80is occluding or otherwise inhibiting the flow of blood to an aneurysm10.

FIG. 19show an embodiment of an occlusive bifurcated supports. As shown inFIG. 19, the occlusive bifurcated support82comprising a first end84, a second end86, and a third end88and having a cylindrical body90positioned between the first, second, and third ends,84,86, and88, respectively. The cylindrical body90further defines an internal lumen92, which is in communication with the first, second, and third ends,84,86, and88, respectively. The occlusive bifurcated support82has first diameter D, thereby enabling insertion and positioning of the device within a blood vessel, and a larger second diameter D′, which is capable of engaging a blood vessel wall. As such, the cylindrical body90may be manufactured from a plurality of interlocking or otherwise joined support members24, and may be reticulated. Reactive material92is incorporated into the cylindrical body82, thereby occluding the aneurysm10formed on the blood vessel14.

FIGS. 20 and 21show an embodiment of an occlusive support device. As shown inFIG. 20, an aneurysm110may form on a blood vessel114at a vascular junction. The blood vessel114includes a first passage116, a second passage118, and a third passage120. The occlusive support device100comprises one or more support members122forming a first end124and a second end126and defining a lumen128therethrough. One or more fenestrations130may be defined by the one or more support members122. When implanted the one or more support member122provide support along line L to the surrounding tissue while permitting blood to flow through the fenestrations130formed by the support members122. An end cap may be secured to the second end126of the occlusive support device100. In one embodiment the end cap132is comprised of a support member122having reactive material133applied thereto. For example, as shown inFIGS. 20 and 21the end cap132comprises a support member122formed in a circular shape of decreasing diameter. In an alternate embodiment, the end cap132may be comprised of a plurality of interwoven support members122thereby forming a fenestrated end cap. The end cap132may be comprised from one or more filamentary elements that can easily be linearized for movement through a catheter. Optionally, the end cap132is comprised of reactive material133. As such, the end cap132may have no reactive material thereon, reactive material133applied thereto, or manufactured solely from one or more reactive materials133. Once implanted, the end cap132decreases the flow of blood from the first passage116of the blood vessel into aneurysm110formed at the vascular junction, thereby directing the blood flow into the second and third passages118,120. As shown inFIG. 21, a space-occupying material136may be injected into the aneurysmal space138formed in the aneurysm110. For example, a catheter134may be advanced though occlusive device100positioned within a blood vessel114and inserted through the end cap132into the aneurysmal space138. Thereafter, a space occupying material136may be injecting or inserted into the aneurysmal space138from the catheter134. Exemplary space occupying material136include, without limitation, hydrogels, hog hair, microfibrillar collagen, various polymeric agents, material suspensions, metallic or radio-opaque materials, and other space filling materials. In an alternate embodiment, therapeutic agents may be delivered to the aneurysmal space138through the catheter134. Once the space occupying material136has been inserted into the aneurysmal space138the end cap132may be used to maintain the space occupying material136within the aneurysm110or to facilitate the formation of a substantially continuous surface bridging the neck of the aneurysm110.

FIGS. 22 and 23show an embodiment of an intra-aneurysmal neck bridge structure. As shown, the intra-aneurysmal neck bridge structure150comprises device body152in communication with at least two engagement members154A and154B cooperatively forming a device joint156. In one embodiment, the device joint156sealably isolates the aneurysm from the flow of blood through the blood vessel. The engagement members154A-B are formed to approximate the radius of curvature of the aneurysm thereby providing an interface between the device and the aneurysm. Reactive portions158A-B are positioned on the engagement members154A-B, respectively. As shown inFIG. 23, a reactive or occlusive material160may be inserted into the aneurysm162prior to or after applying the intra-aneurysmal neck bridge structure150. Such reactive or occlusive materials160may include, for example, a plurality of materials such as hydrogels, hog hair, microfibrillar collagen, various polymeric agents, material suspensions, metallic or radio-opaque materials, and other space filling materials.

The present application further discloses methods of treating vascular aneurysms. In the one embodiment, a method of percutaneously inserting an aneurysmal treatment device into an aneurysm is disclosed and includes percutaneously inserting am aneurysmal treatment device into a blood vessel, advancing the treatment device to a location proximate to a vascular aneurysm, and applying the device to the aneurysm or surrounding tissue without substantially restricting blood flow through the blood vessel. The aneurysm treatment devices disclosed in the present application may be delivered to a situs in vivo in a plurality of manners, including, for example, on guidewires, balloon catheters or through micro-catheters.FIG. 24shows an exemplary embodiment170of an aneurysm treatment device being applied to an aneurysm172using a balloon micro-catheter174.

In practice, the surgeon positions an aneurysm treatment device, for example, an expandable reticulated stent170on a delivery device, for example, a micro-balloon catheter174. Thereafter, a first incision is made proximate a blood vessel and a guidewire176is inserted therein. Commonly, the guidewire will enter the circulatory system through the femoral artery, the femoral vein, the jugular vein, the carotid artery, or a similar blood vessel. The guidewire176may then be directed through the circulatory system to a location proximate to the aneurysm172and, thereafter, made to exit the body through a remote exit point. The delivery device174and stent170may then be advanced along the guidewire176and positioned proximate to the aneurysm172. Typically, visualization methods, such as fluoroscopy, ultrasound visualization, or echogenic location are utilized to precisely position the delivery device near or within the aneurysm172. Once positioned, the micro-balloon174is inflated and the expandable reticulated stent170is applied to the tissue. The portion of the expandable reticulated stent170disposing the reactive material178is positioned proximate to the aneurysm. Thereafter, the delivery device174and guidewire176are removed from the body. The activation of the reactive material178selectively applied to the stent170restricts or occludes the flow of blood to the aneurysm172. The activation process may result from a plurality of occurrences, including, for example, the presence of a physiological pH for an extended period, the presence of an enzyme or other material within the blood, electromagnetic-activation resulting from the introduction of a pre-determined wavelength of electromagnetic energy. The procedure above discloses one such activation method, however, other activation methods known in the art are contemplated.

In closing it is understood that the embodiments of the aneurysm treatment device disclosed herein are illustrative of the principles of the invention. Other modifications may be employed which are within the scope of the invention. Accordingly, the present invention is not limited to that precisely as shown and described in the present invention.