(12) Patent Application Publication (10) Pub. No.: US 2008/0051758 A1 Rioux Et Al

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US 20080051758A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2008/0051758 A1 Rioux et al. (43) Pub. Date: Feb. 28, 2008

(54) MEDICAL DEVICES (21) Appl. No.: 11/458,171 (75) Inventors: Robert F. Rioux, Ashland, MA (22) Filed: Jul. 18, 2006 (US); David J. Sauvageau, Methuen, MA (US) Publication Classification Correspondence Address: ( 51) Int. Cl. FSH & RICHARDSON PC A6M 3L/00 (2006.01) P.O. BOX 1022 (52) U.S. Cl...... 6O4/509 MINNEAPOLIS, MN 55440-1022 (57) ABSTRACT (73) Assignee: BOSTON SCIENTIFIC SCIMED, INC., Maple Grove, Medical devices, and related components and methods, are MN (US) disclosed.

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Patent Application Publication Feb. 28, 2008 Sheet 10 of 10 US 2008/0051758A1

US 2008/0051758 A1 Feb. 28, 2008

MEDICAL DEVICES the lumen of the generally tubular member, and/or at least one contrast agent can be flowed through the lumen of the TECHNICAL FIELD generally tubular member. The method can include viewing the embolic material (e.g., within the lumen of the subject) 0001. This invention relates to medical devices, and to using X-ray fluoroscopy. The method can include resecting related components and methods. liver tissue of the subject. BACKGROUND 0009 Curving the portion of the generally tubular mem ber that carries the inflatable member can include removing 0002 Therapeutic vascular occlusions (embolizations) an inner member from the lumen of the generally tubular are used to prevent or treat pathological conditions in situ. member, and/or disposing an inner member into the lumen Compositions including embolic particles are used for of the generally tubular member. The inner member can occluding vessels in a variety of medical applications. include a needle, a guidewire, a stylet, or a combination Embolic particles can be delivered to a target site in a body thereof. Curving the portion of the generally tubular member of a Subject using, for example, a catheter. that carries the inflatable member can include inflating the inflatable member and/or aligning the portion of the gener SUMMARY ally tubular member with a longitudinal axis of the lumen of 0003. In one aspect, the invention features a method that the subject. includes delivering a catheter into a lumen of a Subject. The 0010. The method can include inflating the inflatable catheter includes a generally tubular member having a member. The method can include delivering at least one lumen, a proximal region, and a distal region, and an embolic material and/or contrast agent into the lumen of the inflatable member carried by a portion of the generally generally tubular member during and/or after inflation of the tubular member. The method also includes curving the inflatable member. When inflated, the inflatable member can portion of the generally tubular member that carries the have a diameter of at least about one centimeter (e.g., at least inflatable member within the lumen of the subject, and about two centimeters, at least about three centimeters) disposing at least one embolic material into the lumen of the and/or at most about four centimeters (e.g., at most about generally tubular member. three centimeters, at most about two centimeters). The 0004. In another aspect, the invention features a method inflatable member can have a wall including at least two that includes delivering a catheter into a lumen of a subject. regions with different thicknesses. The inflatable member The catheter includes a generally tubular member having a can be eccentrically disposed on the portion of the generally lumen, a proximal region, and a distal region, and an tubular member that carries the inflatable member. inflatable member carried by a portion of the generally 0011. The distal region of the generally tubular member tubular member. The method also includes curving the can include a distal end of the generally tubular member, and portion of the generally tubular member that carries the the lumen of the generally tubular member can extend inflatable member within the lumen of the subject, and through the distal end of the generally tubular member. flowing at least one contrast agent into the lumen of the 0012. The lumen of the subject can be a branch of a portal generally tubular member. vein. The lumen of the Subject can have a longitudinal axis. 0005. In an additional aspect, the invention features a Delivering the catheter into the lumen of the subject can method of resecting liver tissue of a subject. The method include inserting the catheter into the lumen of the subject includes delivering a catheter into a lumen of a Subject. The along an axis that is perpendicular to the longitudinal axis of catheter includes a generally tubular member having a the lumen of the subject. Delivering the catheter into the lumen, a proximal region, and a distal region, and an lumen of the Subject can include inserting the catheter inflatable member that is carried by a portion of the gener through a location in the skin of the Subject and through a ally tubular member. The method also includes inflating the location in the lumen of the subject. The location in the inflatable member within the lumen of the subject, curving lumen of the subject can be located at most about three the portion of the generally tubular member that carries the millimeters (e.g., at most about two millimeters, at most inflatable member within the lumen of the subject, disposing about one millimeter), and/or at least about 0.1 millimeter embolic particles into the lumen of the generally tubular (e.g., at least about 0.5 millimeter, at least about one member, delivering the embolic particles into the lumen of millimeter), from the location in the skin of the subject. the Subject, and resecting liver tissue of the Subject. 0013 Embodiments can include one or more of the 0006 Embodiments can also include one or more of the following advantages. following. 0014. The method can be used to deliver one or more 0007. The embolic material can include one or more embolic materials, contrast agents, and/or therapeutic agents embolic gels, embolic particles, and/or embolic coils. The to a target site (e.g., a lumen of a subject) effectively and embolic particles can have an arithmetic mean diameter of efficiently. Curving the distal region of the generally tubular about 3,000 microns or less and/or about one micron or member can allow the embolic materials, contrast agents, O. and/or therapeutic agents to be delivered into the target site 0008. The method can include disposing at least one relatively easily and/or in a relatively high volume. embolic material into the lumen of the generally tubular 0015 The method can include embolizing one or more member, and/or delivering at least one embolic material into branches of a portal vein. The embolization of the branches the lumen of the subject. The method can include rotating of the portal vein can be executed relatively efficiently and the portion of the generally tubular member that carries the with a relatively low likelihood of harm to the subject (e.g., inflatable member within the lumen of the subject. During with a relatively low likelihood of perforation of the walls of and/or after rotation of the portion of the generally tubular the branches). In some embodiments, one or more branches member, at least one embolic material can be disposed into of a portal vein of a subject can be embolized prior to a liver US 2008/0051758 A1 Feb. 28, 2008

resection procedure. This can, for example, enable one or 0032 FIG.5D illustrates the inflation of the balloon of more segments of the liver of the subject to be resected with the balloon catheter of FIG. 5C, and the delivery of embolic relatively little blood loss, and/or enable one or more non material through the balloon catheter and into the lumen of resected segments of the liver of the Subject to experience a the subject. relatively high rate of growth. 0033 FIG. 5E is a cross-sectional view of the lumen of 0016. The distance between the point at which the cath the subject of FIGS.5A-5D, after embolic material has been eter enters the body of a subject and the point at which the delivered into the lumen of the subject. catheter enters a target site (e.g., a lumen of the Subject, Such as a branch of a portal vein) can be relatively short. As a DETAILED DESCRIPTION result, the catheter can be delivered into a target site without 0034 FIG. 1 shows a liver 10 of a subject 12, as well as having to navigate a long distance within the body of the a portal vein 14, a Superior mesenteric vein 16, an inferior Subject first. This can, for example, reduce procedure time mesenteric vein 18, a splenic vein 20, and a gastric vein 22. and/or result in a relatively low likelihood of injury to the Portal vein 14, which is formed by the union of superior Subject. mesenteric vein 16 and splenic vein 20, drains blood into 0017. The method can be used to provide a targeted area liver 10. Portal vein 14 has many different branches that for embolization, therapeutic agent delivery, and/or contrast extend into, and provide blood to, different segments of liver agent delivery. For example, in Some embodiments, a cath 10. eter can be used to occlude a portion of a lumen of a subject 0035. In some embodiments, it may be desirable to and to deliver one or more embolic materials, therapeutic embolize one or more of the branches of portal vein 14. For agents, and/or contrast agents into a specific region of the example, in certain embodiments, prior to a procedure in lumen of the subject that is defined by the occlusion. which one or more segments of liver 10 are to be resected 0018. The method can include occluding a lumen of a (e.g., because they are tumorous), one or more of the Subject, such as a branch of a portal vein, without using branches of portal vein 14 can be embolized. This embo X-ray fluoroscopy prior to or during the occlusion. In some lization of selected branches of portal vein 14 can be used to embodiments, the method can include using ultrasound to slow or stop blood flow to segments of liver 10 that will be locate a lumen of a subject, Such as a branch of a portal vein, resected, and to redirect blood flow to segments of liver 10 and percutaneously inserting a balloon catheter into the that will not be resected. The redireaction of blood flow to lumen after identifying its location. segments of liver 10 that will not be resected can initiate 0019. The method can include inflating an eccentrically hypertrophy, or exaggerated growth, of those segments. The disposed balloon of a balloon catheter within a lumen of a hypertrophy can be used to develop healthy liver tissue prior Subject, and the eccentricity of the balloon can cause the to resection of unhealthy liver tissue. inflated balloon to be relatively unlikely to slip and/or 0036 FIGS. 2A-2D illustrate a procedure that can be become dislodged from its location within the lumen of the used to embolize a branch 24 of portal vein 14. Subject. 0037 First, branch 24 is located using ultrasound. Then, 0020 Features and advantages are in the description, as shown in FIG. 2A, a needle 26 (e.g., a diagnostic needle drawings, and claims. from an AccuStickTM Introducer System from Boston Sci entific Corp.) is inserted through a layer 28 formed of skin DESCRIPTION OF DRAWINGS and/or tissue, and into branch 24. Branch 24 has a longitu dinal axis L., and needle 26 is inserted into branch 24 at an 0021 FIG. 1 is an illustration of a liver of a subject. angle C. that is perpendicular to longitudinal axis L. 0022 FIG. 2A illustrates the delivery of an embodiment 0038. As shown in FIG. 2B, a balloon catheter 30 is then of a needle into a lumen of a Subject. inserted over needle 26 and into branch 24, also at an angle 0023 FIG. 2B illustrates the delivery of an embodiment C. that is perpendicular to longitudinal axis L of branch 24. of balloon catheter into the lumen of the subject of FIG. 2A. Balloon catheter 30 enters layer 28 at a location L1 and 0024 FIG. 2C illustrates the inflation of a balloon of the enters branch 24 at a location L2. Typically, the distance D balloon catheter of FIG. 2B within the lumen of the subject. between location L1 and location L2 can be relatively short, 0025 FIG. 2D illustrates the delivery of embolic material such that balloon catheter 30 does not have to navigate a through the balloon catheter of FIG. 2C and into the lumen long and/or tortuous path to reach branch 24. In some of the subject. embodiments, distance D can be at most about three milli 0026 FIG. 3A is a cross-sectional view of an embodi meters (e.g., at most about two millimeters) and/or at least ment of a balloon catheter. about one millimeter (e.g., at least about two millimeters). The delivery of balloon catheter 30 into branch 24, and/or 0027 FIG. 3B is a cross-sectional view of a component the location of balloon catheter 30 within branch 24, can be of the balloon catheter of FIG. 3A. confirmed using, for example, ultrasound. 0028 FIG. 4 illustrates the delivery of embolic material 0039. As shown in FIG. 2B, balloon catheter 30 includes into a lumen of a subject. a generally tubular member 32 having a proximal region 34 0029 FIG. 5A illustrates the delivery of embolic material and a distal region 36 including the distal end 37 of generally through an embodiment of a balloon catheter and into a tubular member 32. Balloon catheter 30 also includes a lumen of a Subject. balloon 38 that is disposed on distal region 36 of generally 0030 FIG. 5B illustrates the partial deflation of a balloon tubular member 32. Generally tubular member 32 has a of the balloon catheter of FIG. 5A. central lumen 40 that allows generally tubular member 32 to 0031 FIG. 5C illustrates the rotation of the partially be inserted over needle 26. Generally tubular member 32 deflated balloon of the balloon catheter of FIG. SB within also has an inflation lumen 42 including a proximal end 44 the lumen of the subject. and a distal end 46. Distal end 46 forms an opening 48 in US 2008/0051758 A1 Feb. 28, 2008

generally tubular member 32, such that inflation lumen 42 is or less; about five microns or less) and/or about one micron in fluid communication with balloon 38. or more (e.g., about five microns or more; about 10 microns 0040. After balloon catheter 30 has been inserted into or more; about 50 microns or more; about 100 microns or branch 24 of portal vein 14, needle 26 is removed from more; about 300 microns or more; about 400 microns or central lumen 40 of generally tubular member 32. As shown more; about 500 microns or more; about 700 microns or in FIG. 2C, balloon 38 is inflated by flowing inflation fluid more; about 900 microns or more; about 1,000 microns or (e.g., a saline solution mixed with a radiopaque contrast more; about 1,200 microns or more; about 1,500 microns or agent) through inflation lumen 42. The removal of needle 26 more; about 2,000 microns or more; about 2,500 microns or from generally tubular member 32, and the inflation of more). The arithmetic mean diameter of a group of particles balloon 28, cause distal region 36 of generally tubular can be determined using a Beckman Coulter RapidVUE member 32 to become curved so that it is aligned with Image Analyzer version 2.06 (Beckman Coulter, Miami, longitudinal axis L of branch 24. Appropriate alignment can Fla.). Briefly, the RapidVUE takes an image of continuous be achieved by positioning a guidewire, followed by posi tone (gray-scale) form and converts it to a digital form tioning balloon 38 over the guidewire. through the process of sampling and quantization. The 0041. As shown in FIG. 2D, after balloon 38 has been arithmetic mean diameter of a group of particles (e.g., in a inflated, embolic particles 50 are added into central lumen composition) can be determined by dividing the sum of the 40 of generally tubular member 32, and are delivered into diameters of all of the particles in the group by the number branch 24 of portal vein 14. A sufficient volume of embolic of particles in the group. particles 50 can be delivered into branch 24 to result in the 0045 Embolic particles 50 can be formed of any of a embolization of branch 24. In some embodiments, embolic number of different materials. In some embodiments, embo particles 50 can be disposed within a carrier fluid to form a lic particles 50 can be formed of one or more polymers. composition (e.g., a Suspension), which can be delivered Examples of polymers include polyvinyl alcohols, poly through generally tubular member 32. The carrier fluid can acrylic acids, polymethacrylic acids, poly vinyl Sulfonates, be, for example, a pharmaceutically acceptable carrier, Such carboxymethyl celluloses, hydroxyethyl celluloses, substi as saline, contrast agent, therapeutic agent, or a combination tuted celluloses, polyacrylamides, polyethylene glycols, of these carriers. In certain embodiments, the carrier fluid polyamides, polyureas, polyurethanes, polyesters, poly can include deionized water, water for injection, liquid ethers, polystyrenes, polysaccharides (e.g., alginate), poly polymer, gel polymer, gas, or a combination of these carri lactic acids, polyethylenes, polymethylmethacrylates, poly ers. In certain embodiments, embolic particles 50 may not be caprolactones, polyglycolic acids, poly(lactic-co-glycolic) Suspended in a carrier fluid. For example, embolic particles acids (e.g., poly(d-lactic-co-glycolic) acids) and copolymers 50 alone can be delivered through generally tubular member or mixtures thereof. In some embodiments, embolic particles 32 and into branch 24. 50 can be formed of one or more styrenic block copolymers, 0042 Typically, the size of embolic particles 50 can be Such as styrene-isobutylene-styrene block copolymer selected to provide sufficient embolization of a lumen of a (SIBS). subject, such as branch 24 of portal vein 14. 0046 Particles are described, for example, in Lanphere et 0043. In some embodiments, one or more of embolic al., U.S. Patent Application Publication No. US 2004/ particles 50 can have a maximum dimension (e.g., a diam 0096662 A1, published on May 20, 2004, and entitled eter) of about 3,000 microns or less (e.g., about 2,500 “Embolization', DiCarlo et al., U.S. patent application Ser. microns or less; about 2,000 microns or less; about 1,500 No. 11/111.511, filed on Apr. 21, 2005, and entitled “Par microns or less; about 1,200 microns or less; about 1,000 ticles”. Song et al., U.S. patent application Ser. No. 1 1/314, microns or less; about 900 microns or less; about 700 056, filed on Dec. 21, 2005, and entitled “Block Copolymer microns or less; about 500 microns or less; about 400 Particles”. Song et al., U.S. patent application Ser. No. microns or less; about 300 microns or less; about 100 11/314,557, filed on Dec. 21, 2005, and entitled “Block microns or less; about 50 microns or less; about 10 microns Copolymer Particles, and Song, U.S. patent application Ser. or less; about five microns or less) and/or about one micron No. 1 1/355,301, filed on Feb. 15, 2006, and entitled “Block or more (e.g., about five microns or more; about microns or Copolymer Particles', all of which are incorporated herein more; about 50 microns or more; about 100 microns or by reference. more; about 300 microns or more; about 400 microns or 0047 FIG. 3A shows an enlarged cross-sectional view of more; about 500 microns or more; about 700 microns or balloon catheter 30. As shown in FIG. 3A, balloon 38, which more; about 900 microns or more; about 1,000 microns or is eccentrically disposed on generally tubular member 32. more; about 1,200 microns or more; about 1,500 microns or has a diameter D1 when balloon 38 is inflated. In some more; about 2,000 microns or more; about 2,500 microns or embodiments, diameter D1 can be at least about five milli more). For example, in certain embodiments, one or more of meters (e.g., at least about 10 millimeters, at least about 20 embolic particles 50 can have a maximum dimension (e.g., millimeters, at least about 30 millimeters) and/or at most a diameter) of from about five microns to about 1,200 about 40 millimeters (e.g., at most about 30 millimeters, at microns. most about 20 millimeters, at most about 10 millimeters). In 0044. In certain embodiments, embolic particles 50 can certain embodiments, diameter D1 can be from about 25 have an arithmetic mean diameter of about 3,000 microns or millimeters to about 33 millimeters. less (e.g., about 2,500 microns or less; about 2,000 microns 0048 Balloon 38 can be formed using, for example, a or less; about 1,500 microns or less; about 1,200 microns or molding process. Typically, balloon 38 can be formed of one less; about 1,000 microns or less; about 900 microns or less; or more polymers (e.g., homopolymers, copolymers). about 700 microns or less; about 500 microns or less; about Examples of polymers that can be used in balloon 38 include 400 microns or less; about 300 microns or less; about 100 silicone, polyurethanes, polyesters (e.g., polyethylene microns or less; about 50 microns or less; about 10 microns terephthalate (PET) polymers, polybutylene terephthalate US 2008/0051758 A1 Feb. 28, 2008

(PBT) polymers), polyamides (e.g., nylons such as aliphatic 0053. In certain embodiments, multiple (e.g., two, three) nylons and/or aromatic nylons), and polyethylenes. In some balloon catheters can be used together in an embolization embodiments, balloon 38 can be formed of one or more procedure. For example, FIG. 4 shows a branch 100 of a polyether block polyamide copolymers. In certain embodi portal vein that is located beneath a layer 104 of skin and/or ments, balloon 38 can be formed of latex. In some embodi tissue. Two balloon catheters 106 and 108 have been ments, balloon 38 can include a blend of polymers. Balloons (e.g., balloon materials) are described, for example, in Chin inserted into branch 100, and are used to deliver embolic et al., U.S. Patent Application Publication No. US 2002/ particles 110 into branch 100. As shown, balloon catheter 0165523 A1, published on Nov. 7, 2002, and entitled “Mul 106 includes a generally tubular member 112 having a tilayer Medical Balloon', Pierre et al., U.S. Patent Applica central lumen 114 and an inflation lumen 116, and also tion Publication No. US 2004/0078052 A1, published on includes a balloon 118 that is in fluid communication with Apr. 22, 2004, and entitled “Multilayer Medical Device', inflation lumen 116. Balloon 118 is inflated, and occludes a Chinet al., U.S. Pat. No. 6,951,675, and Sahatian et al., U.S. portion 120 of branch 100. Balloon catheter 108 includes a Pat. No. 5,306.246, each of which is incorporated herein by generally tubular member 121 having a central lumen 122 reference. and an inflation lumen 124, and also includes a balloon 126 0049 FIG. 3B shows generally tubular member 32 in its that is in fluid communication with inflation lumen 124. straight form. As shown in FIG. 3B, when in its straight Balloon 126 is inflated, and occludes another portion 128 of form, generally tubular member 32 has a length L2. In some branch 100. Embolic particles 110 are disposed into central embodiments (e.g., some embodiments in which generally lumens 114 and 122 of balloon catheters 106 and 108, and tubular member 32 is designed to travel a relatively short delivered into branch 100. The occlusion of portions 120 and distance within a body of a subject before reaching a target 128 of branch 100 by balloons 118 and 126 provides a site), length L2 can be relatively short. In certain embodi targeted region of branch 100 for embolization by embolic ments, length L2 can be at least about 10 centimeters (e.g., particles 110. at least about 20 centimeters, at least about 30 centimeters) 0054. In some embodiments, a balloon catheter can be and/or at most about 40 centimeters (e.g., at most about 30 used to define a target site for resection. For example, FIG. centimeters, at most about 20 centimeters). In some embodi 5A shows a branch 200 of a portal vein in a body of a subject ments, length L2 can be about 30 centimeters. that is located beneath a layer 202 of skin and/or tissue. A 0050. Before generally tubular member 32 is inserted balloon catheter 204 including a generally tubular member over needle 26, distal region 36 of generally tubular member 206 having a central lumen 208 and an inflation lumen 210, 32 is curved. The insertion of generally tubular member 32 and a balloon 212, has been inserted into branch 200. An over needle 26 causes distal region 36 to temporarily embolic gel 214 is disposed into central lumen 208 of straighten. When needle 26 is subsequently removed from generally tubular member 206, and is delivered into branch generally tubular member 32, distal region 36 re-assumes its 200. As shown in FIG. 5B, after embolic gel 214 has been curved form. delivered into branch 200, balloon 212 is slightly deflated, 0051. In certain embodiments, distal region 36 of gener and, as shown in FIG.5C, balloon catheter 204 is rotated 180 ally tubular member 32 can be formed of one or more shape degrees. Thereafter, and as shown in FIG. 5D, an embolic memory materials. Examples of shape memory materials gel 216 is disposed into central lumen 208 of generally include shape memory polymers, such as shape memory tubular member 206, and is delivered into branch 200. polyurethanes (available from Mitsubishi), polynorbornene Balloon catheter 204 is then removed from branch 200, (e.g., NorsorexTM, available from Mitsubishi), polymethyl which, as shown in FIG. 5E, includes a region 218 that is methacrylate (PMMA), poly(vinyl chloride), polyethylene occluded by embolic gel 214, and a region 220 that is (e.g., crystalline polyethylene), polyisoprene (e.g., trans occluded by embolic gel 216. Embolic gels 214 and 216 can polyisoprene), styrene-butadiene copolymer, rubbers, or be formed of the same materials or of different materials. In photocrosslinkable polymers including azo-dye, Zwitteri certain embodiments, embolic gel 214 and/or embolic gel onic and/or other photochromic materials (as described in 216 can include one or more polymers. Embolic gels are Shape Memory Materials, Otsuka and Wayman, Cambridge described, for example, in U.S. Patent Application Publica University Press, 1998). Additional examples of shape tion No. US 2006/0045900 A1, published on Mar. 2, 2006, memory polymers include shape memory plastics available and entitled “Embolization', which is incorporated herein from MnemoScience GmbH Pauwelsstrasse 19, D-52074 by reference. Aachen, Germany. 0055. In some embodiments, embolic gels 214 and 216 0.052. In some embodiments, when a balloon such as can include one or more radiopaque materials, materials that balloon 38, which is eccentrically disposed on generally are visible by magnetic resonance imaging (MRI-visible tubular member 32, is inflated, the eccentricity of the materials), ferromagnetic materials, and/or contrast agents balloon can help to cause the distal region of the generally (e.g., ultrasound contrast agents). These materials can allow tubular member to become curved. As the larger side of the embolic gels 214 and 216 to be viewed using, for example, eccentrically disposed balloon expands, the expansion can X-ray fluoroscopy, MRI, and/or ultrasound. When viewed cause the distal region of the generally tubular member to using these techniques, embolic gels 214 and 216 can define curve toward the smaller side of the eccentrically disposed a non-occluded region 222 between them. In certain balloon. embodiments, a physician can use non-occluded region 222 US 2008/0051758 A1 Feb. 28, 2008

as a defined area in which resection can occur. Radiopaque antibodies, anti-platelet receptor antibodies, aspirin, pros materials, MRI-visible materials, ferromagnetic materials, taglandin inhibitors, platelet inhibitors and tick antiplatelet and contrast agents are described, for example, in Rioux et factors or peptides; vascular cell growth promoters such as al., U.S. Patent Application Publication No. US 2004/ growth factors, transcriptional activators, and translational 01.01564 A1, published on May 27, 2004, and entitled promoters; vascular cell growth inhibitors such as growth “Embolization', which is incorporated herein by reference. factor inhibitors (e.g., PDGF inhibitor-Trapidil), growth 0056. In some embodiments, a balloon catheter can be factor receptor antagonists, transcriptional repressors, trans used in a procedure in which one or more therapeutic agents lational repressors, replication inhibitors, inhibitory antibod (e.g., a combination of therapeutic agents) are delivered into ies, antibodies directed against growth factors, bifunctional a target site in a body of a Subject. In certain embodiments, molecules consisting of a growth factor and a cytotoxin, the therapeutic agents can be incorporated into and/or onto bifunctional molecules consisting of an antibody and a embolic material that is delivered into the target site using cytotoxin; protein kinase and tyrosine kinase inhibitors (e.g., the balloon catheter. In some embodiments, the therapeutic tyrphostins, genistein, quinoxalines); prostacyclin analogs; agents can provide a medium in which embolic material is cholesterol-lowering agents; angiopoietins; antimicrobial delivered to a target site using the balloon catheter. In certain agents such as triclosan, cephalosporins, aminoglycosides embodiments, the therapeutic agents and/or can be delivered and nitrofurantoin; cytotoxic agents, cytostatic agents and to the target site independently of any embolic material. cell proliferation affectors; vasodilating agents; and agents 0057 Therapeutic agents include genetic therapeutic that interfere with endogenous vasoactive mechanisms. agents, non-genetic therapeutic agents, and cells, and can be negatively charged, positively charged, amphoteric, or neu 0059 Exemplary genetic therapeutic agents include: anti tral. Therapeutic agents can be, for example, materials that sense DNA and RNA; DNA coding for anti-sense RNA, are biologically active to treat physiological conditions; tRNA or rRNA to replace defective or deficient endogenous pharmaceutically active compounds; proteins; gene thera molecules, angiogenic factors including growth factors such pies; nucleic acids with and without carrier vectors (e.g., as acidic and basic fibroblast growth factors, vascular endot recombinant nucleic acids, DNA (e.g., naked DNA), cDNA, helial growth factor, epidermal growth factor, transforming RNA genomic DNA, cDNA or RNA in a non-infectious growth factor C. and B, platelet-derived endothelial growth vector or in a viral vector which may have attached peptide factor, platelet-derived growth factor, tumor necrosis factor targeting sequences, antisense nucleic acids (RNA, DNA)); a, hepatocyte growth factor, and insulin like growth factor, oligonucleotides; gene?vector Systems (e.g., anything that cell cycle inhibitors including CD inhibitors, thymidine allows for the uptake and expression of nucleic acids); DNA kinase (“TK) and other agents useful for interfering with chimeras (e.g., DNA chimeras which include gene cell proliferation, and the family of bone morphogenic sequences and encoding for ferry proteins such as membrane proteins (“BMP’s”), including BMP2, BMP3, BMP4, translocating sequences (“MTS”) and herpes simplex BMP5, BMP6 (Vgr1), BMP7 (OP1), BMP8, BMP9, virus-1 (“VP22)); compacting agents (e.g., DNA compact BMP10, BM11, BMP12, BMP13, BMP14, BMP15, and ing agents); viruses; polymers; hyaluronic acid; proteins BMP16. Currently preferred BMP's are any of BMP2, (e.g., enzymes such as ribozymes, asparaginase); immuno logic species; nonsteroidal anti-inflammatory medications; BMP3, BMP4, BMP5, BMP6 and BMP7. These dimeric oral contraceptives; progestins; gonadotrophin-releasing proteins can be provided as homodimers, heterodimers, or hormone agonists; chemotherapeutic agents; and radioactive combinations thereof, alone or together with other mol species (e.g., radioisotopes, radioactive molecules, such as ecules. Alternatively or additionally, molecules capable of Y90 particles). Non-limiting examples of therapeutic agents inducing an upstream or downstream effect of a BMP can be include anti-thrombogenic agents; antioxidants; angiogenic provided. Such molecules include any of the "hedgehog and anti-angiogenic agents and factors; anti-proliferative proteins, or the DNA’s encoding them. Vectors of interest agents (e.g., agents capable of blocking Smooth muscle cell for delivery of genetic therapeutic agents include: plasmids; proliferation, such as rapamycin); calcium entry blockers viral vectors such as adenovirus (AV), adenoassociated virus (e.g., Verapamil, diltiazem, nifedipine); and Survival genes (AAV) and lentivirus; and non-viral vectors such as lipids, which protect against cell death (e.g., anti-apoptotic Bcl-2 liposomes and cationic lipids. family factors and Akt kinase). 0060 Cells include cells of human origin (autologous or 0058 Exemplary non-genetic therapeutic agents include: allogeneic), including stem cells, or from an animal source anti-thrombotic agents such as heparin, heparin derivatives, (Xenogeneic), which can be genetically engineered if desired urokinase, and PPack (dextrophenylalanine proline arginine to deliver proteins of interest. chloromethylketone); anti-inflammatory agents such as dex amethasone, prednisolone, corticosterone, budesonide, 0061. Several of the above and numerous additional estrogen, acetyl salicylic acid, Sulfasalazine and therapeutic agents are disclosed in Kunz et al., U.S. Pat. No. mesalamine; antineoplastic/antiproliferative/anti-mitotic 5,733.925, which is incorporated herein by reference. Thera agents such as paclitaxel, 5-fluorouracil, cisplatin, methotr peutic agents disclosed in this patent include the following: exate, doxorubicin, vinblastine, Vincristine, epothilones, 0062 “Cytostatic agents” (i.e., agents that prevent or endostatin, angiostatin, angiopeptin, monoclonal antibodies delay cell division in proliferating cells, for example, by capable of blocking Smooth muscle cell proliferation, and inhibiting replication of DNA or by inhibiting spindle fiber thymidine kinase inhibitors; anesthetic agents such as formation). Representative examples of cytostatic agents lidocaine, bupivacaine and ropivacaine; anti-coagulants include modified toxins, methotrexate, adriamycin, radionu such as D-Phe-Pro-Arg chloromethyl ketone, an RGD pep clides (e.g., such as disclosed in Fritzberg et al., U.S. Pat. tide-containing compound, heparin, hirudin, antithrombin No. 4,897.255), protein kinase inhibitors, including stauro compounds, platelet receptor antagonists, anti-thrombin sporin, a protein kinase C inhibitor of the following formula: US 2008/0051758 A1 Feb. 28, 2008

beta or functional equivalents, derivatives or analogs thereof. Suramin, nitric oxide releasing compounds (e.g., NHMe nitroglycerin) or analogs or functional equivalents thereof, paclitaxel or analogs thereof (e.g., taxotere), inhibitors of specific enzymes (such as the nuclear enzyme DNA topoi somerase II and DNA polymerase, RNA polymerase, adenyl guanyl cyclase), Superoxide dismutase inhibitors, terminal deoxynucleotidyl-transferase, reverse transcriptase, anti sense oligonucleotides that Suppress Smooth muscle cell proliferation and the like. Other examples of “cytostatic agents' include peptidic or mimetic inhibitors (i.e., antago nists, agonists, or competitive or non-competitive inhibitors) of cellular factors that may (e.g., in the presence of extra cellular matrix) trigger proliferation of Smooth muscle cells as well as diindoloalkaloids having one of the following or pericytes: e.g., cytokines (e.g., interleukins such as IL-1). general structures: growth factors (e.g., PDGF, TGF-alpha or -beta, tumor necrosis factor, Smooth muscle- and endothelial-derived

growth factors, i.e., endothelin, FGF), homing receptors (e.g., for platelets or leukocytes), and extracellular matrix receptors (e.g., integrins). Representative examples of useful therapeutic agents in this category of cytostatic agents addressing Smooth muscle proliferation include: Subfrag ments of heparin, triazolopyrimidine (trapidil; a PDGF antagonist), lovastatin, and prostaglandins E1 or I2. 0063 Agents that inhibit the intracellular increase in cell Volume (i.e., the tissue volume occupied by a cell). Such as cytoskeletal inhibitors or metabolic inhibitors. Representa tive examples of cytoskeletal inhibitors include colchicine, vinblastin, cytochalasins, paclitaxel and the like, which act on microtubule and microfilament networks within a cell. Representative examples of metabolic inhibitors include staurosporin, trichothecenes, and modified diphtheria and ricin toxins, Pseudomonas exotoxin and the like. Trichoth ecenes include simple trichothecenes (i.e., those that have only a central sesquiterpenoid structure) and macrocyclic trichothecenes (i.e., those that have an additional macrocy clic ring), e.g., a verrucarins or roridins, including Verru carin A, Verrucarin B, Verrucarin J (Satratoxin C), Roridin A. Roridin C, Roridin D. Roridin E (Satratoxin D), Roridin H 0064. Agents acting as an inhibitor that blocks cellular protein synthesis and/or secretion or organization of extra cellular matrix (i.e., an “anti-matrix agent”). Representative examples of “anti-matrix agents' include inhibitors (i.e., agonists and antagonists and competitive and non-competi tive inhibitors) of matrix synthesis, secretion and assembly, organizational cross-linking (e.g., transglutaminases cross linking collagen), and matrix remodeling (e.g., following wound healing). A representative example of a useful thera peutic agent in this category of anti-matrix agents is colchi cine, an inhibitor of secretion of extracellular matrix. Another example is tamoxifen for which evidence exists regarding its capability to organize and/or stabilize as well as diminish Smooth muscle cell proliferation following angioplasty. The organization or stabilization may stem from the blockage of vascular Smooth muscle cell maturation in to a pathologically proliferating form. as well as stimulators of the production or activation of 0065 Agents that are cytotoxic to cells, particularly can TGF-beta, including Tamoxifen and derivatives of func cer cells. Preferred agents are Roridin A, Pseudomonas tional equivalents (e.g., plasmin, heparin, compounds exotoxin and the like or analogs or functional equivalents capable of reducing the level or inactivating the lipoprotein thereof. A plethora of Such therapeutic agents, including Lp(a) or the glycoprotein apolipoprotein(a)) thereof. TGF radioisotopes and the like, have been identified and are US 2008/0051758 A1 Feb. 28, 2008

known in the art. In addition, protocols for the identification ocreotide), TGF-B pathway agents such as polyanionic of cytotoxic moieties are known and employed routinely in agents (heparin, fucoidin), decorin, and TGF-B antibodies, the art. EGF pathway agents (e.g., EGF antibodies, receptor antago 0066. A number of the above therapeutic agents and nists, chimeric fusion proteins), TNF-C. pathway agents (e.g., thalidomide and analogs thereof), thromboxane A2 several others have also been identified as candidates for (TXA2) pathway modulators (e.g., Sulotroban, Vapiprost, vascular treatment regimens, for example, as agents target daZOXiben, ridogrel), protein tyrosine kinase inhibitors (e.g., ing restenosis. Such agents include one or more of the tyrphostin, genistein, and quinoxaline derivatives); MMP following: calcium-channel blockers, including benzothi pathway inhibitors (e.g., marimastat, illomastat, metastat), azapines (e.g., diltiazem, clentiaZem); dihydropyridines and cell motility inhibitors (e.g., cytochalasin B); antipro (e.g., nifedipine, amlodipine, nicardapine); phenylalky liferative/antineoplastic agents including antimetabolites lamines (e.g., Verapamil); Serotonin pathway modulators, Such as purine analogs (e.g., 6-mercaptopurine), pyrimidine including 5-HT antagonists (e.g., ketanserin, naftidrofuryl) analogs (e.g., cytarabine and 5-fluorouracil) and methotrex and 5-HT uptake inhibitors (e.g., fluoxetine); cyclic nucle ate, nitrogen mustards, alkyl Sulfonates, ethylenimines, anti otide pathway agents, including phosphodiesterase inhibi biotics (e.g., daunorubicin, doxorubicin, daunomycin, bleo tors (e.g., cilostazole, dipyridamole), adenylate? guanylate mycin, mitomycin, penicillins, cephalosporins, ciprofalxin, cyclase stimulants (e.g., forskolin), and adenosine analogs; Vancomycins, aminoglycosides, quinolones, polymyxins, catecholamine modulators, including C-antagonists (e.g., erythromycins, tertacyclines, chloramphenicols, clindamy prazosin, bunaZosine), B-antagonists (e.g., propranolol), and cins, linomycins, Sulfonamides, and their homologs, ana C/B-antagonists (e.g., labetalol, carvedilol); endothelin logs, fragments, derivatives, and pharmaceutical salts), receptor antagonists; nitric oxide donors/releasing mol nitrosoureas (e.g., carmustine, lomustine) and cisplatin, ecules, including organic nitrates/nitrites (e.g., nitroglycerin, agents affecting microtubule dynamics (e.g., vinblastine, isosorbide dinitrate, amyl nitrite), inorganic nitroso com Vincristine, colchicine, paclitaxel, epothilone), caspase acti pounds (e.g., sodium nitroprusside), Sydnonimines (e.g., vators, proteasome inhibitors, angiogenesis inhibitors (e.g., molsidomine, linsidomine), nonoates (e.g., diazenium endostatin, angiostatin and squalamine), and rapamycin, diolates, NO adducts of alkanediamines), S-nitroso com pounds, including low molecular weight compounds (e.g., cerivastatin, flavopiridol and Suramin; matrix deposition/ S-nitroso derivatives of captopril, glutathione and N-acetyl organization pathway inhibitors (e.g., halofuginone or other penicillamine) and high molecular weight compounds (e.g., quinazolinone derivatives, tranilast); endothelialization S-nitroso derivatives of proteins, peptides, oligosaccharides, facilitators (e.g., VEGF and RGD peptide); and blood rhe polysaccharides, synthetic polymerSfoligomers and natural ology modulators (e.g., pentoxifylline). polymers/oligomers), C-nitroso-, O-nitroso- and N-nitroso 0067. Other examples of therapeutic agents include anti compounds, and L-arginine; ACE inhibitors (e.g., cilaZapril, tumor agents, such as docetaxel, alkylating agents (e.g., fosinopril, enalapril); ATII-receptor antagonists (e.g., Sarala mechlorethamine, chlorambucil, cyclophosphamide, mel sin, losartin); platelet adhesion inhibitors (e.g., albumin, phalan, ifosfamide), plant alkaloids (e.g., etoposide), inor polyethylene oxide); platelet aggregation inhibitors, includ ganic ions (e.g., cisplatin), biological response modifiers ing aspirin and thienopyridine (ticlopidine, clopidogrel) and (e.g., interferon), and hormones (e.g., tamoxifen, flutamide), GP IIb/IIIa inhibitors (e.g., abciximab, epitifibatide, as well as their homologs, analogs, fragments, derivatives, tirofiban, intergrilin); coagulation pathway modulators, and pharmaceutical salts. including heparinoids (e.g., heparin, low molecular weight 0068 Additional examples of therapeutic agents include heparin, dextran Sulfate, B-cyclodextrin tetradecasulfate), organic-soluble therapeutic agents, such as mithramycin, thrombin inhibitors (e.g., hirudin, hirulog, PPACK (D-phe cyclosporine, and plicamycin. Further examples of thera L-propyl-L-arg-chloromethylketone), argatroban), FXa peutic agents include pharmaceutically active compounds, inhibitors (e.g., antistatin, TAP (tick anticoagulant peptide)), anti-sense genes, viral, liposomes and cationic polymers Vitamin K inhibitors (e.g., warfarin), and activated protein (e.g., selected based on the application), biologically active C; cyclooxygenase pathway inhibitors (e.g., aspirin, ibupro Solutes (e.g., heparin), prostaglandins, prostcyclins, L-argi fen, flurbiprofen, indomethacin, Sulfinpyrazone); natural and nine, nitric oxide (NO) donors (e.g., lisidomine, molsidom synthetic corticosteroids (e.g., dexamethasone, predniso ine, NO-protein adducts, NO-polysaccharide adducts, poly lone, methprednisolone, hydrocortisone); lipoxygenase meric or oligomeric NO adducts or chemical complexes), pathway inhibitors (e.g., nordihydroguairetic acid, caffeic enoxaparin, Warafin Sodium, dicumarol, interferons, inter acid; leukotriene receptor antagonists; antagonists of E- and leukins, chymase inhibitors (e.g., Tranilast), ACE inhibitors P-selectins; inhibitors of VCAM-1 and ICAM-1 interac (e.g., Enalapril), serotonin antagonists, 5-HT uptake inhibi tions; prostaglandins and analogs thereof, including pros tors, and beta blockers, and other antitumor and/or chemo taglandins such as PGEL and PGI2; prostacyclins and pros therapy drugs, such as BiCNU, buSulfan, carboplatinum, tacyclin analogs (e.g., ciprostene, epoprostenol, carbacyclin, cisplatinum, cytoxan, DTIC, fludarabine, mitoxantrone, vel iloprost, beraprost); macrophage activation preventers (e.g., ban, VP-16, herceptin, leustatin, navelbine, rituxan, and bisphosphonates); HMG-CoA reductase inhibitors (e.g., lov taXOtere. astatin, pravastatin, fluvastatin, simvastatin, cerivastatin): 0069. Therapeutic agents are described, for example, in fish oils and omega-3-fatty acids; free-radical scavengers/ DiMatteo et al., U.S. Patent Application Publication No. US antioxidants (e.g., probucol, Vitamins C and E. ebselen, 2004/0076582 A1, published on Apr. 22, 2004, and entitled retinoic acid (e.g., trans-retinoic acid), SOD mimics); agents “Agent Delivery Particle', and in Schwarz et al., U.S. Pat. affecting various growth factors including FGF pathway No. 6,368,658, both of which are incorporated herein by agents (e.g., bFGF antibodies, chimeric fusion proteins), reference. PDGF receptor antagonists (e.g., trapidil), IGF pathway 0070 While certain embodiments have been described, agents (e.g., Somatostatin analogs such as angiopeptin and other embodiments are possible. US 2008/0051758 A1 Feb. 28, 2008

0071. As an example, in some embodiments, a catheter Dec. 1, 2004, and entitled "Embolic Coils', and in Buiser et can include a generally tubular member having a distal al., U.S. patent application Ser. No. 11/311,617, filed on region that is not formed of a shape-memory material and/or Dec. 19, 2005, and entitled “Coils, both of which are that is not curved prior to being delivered into a lumen of a incorporated herein by reference. Subject. In some embodiments, the distal region of the (0075. As a further example, while the delivery of embolic generally tubular member can be formed of one or more material using a balloon catheter has been described, in polymers having Sufficient stiffness to allow the distal region Some embodiments, one or more other types of materials can to become curved. For example, in certain embodiments, the alternatively or additionally be delivered into a body of a distal region can include one or more polymers (e.g., poly Subject using a balloon catheter. For example, in certain urethanes, polyethylenes, polyvinylchlorides, polyamide embodiments, one or more contrast agents, such as one or polyether block copolymers) having a hardness of for more radiopaque and/or MRI contrast agents, can be deliv example, from 55 Shore D durometer to 72 Shore D durom ered into a body of a Subject using a balloon catheter. eter. The distal region can become curved (e.g., after the Examples of radiopaque contrast agents include generally tubular member has been inserted into a lumen of OmnipaqueTM, Renocal(R), iodiamide meglumine, diatrizoate a subject) by inserting a device into the lumen of the meglumine, ipodate calcium, ipodate Sodium, iodamide generally tubular member, and manipulating the device Sodium, iothalamate Sodium, iopamidol, and metrizamide. within the lumen such that the device causes the distal region Radiopaque contrast agents are commercially available to become curved. from, for example, Bracco Diagnostic. Examples of MRI 0072. As another example, in certain embodiments, a contrast agents include Superparamagnetic iron oxides (e.g., catheter can include a balloon having a relatively thick ferumoxides, ferucarbotran, ferumoXSil, ferumoXtran (e.g., portion and a relatively thin portion. For example, the ferumoxtran-10), PEG-feron, ferucarbotran); gadopentetate catheter can include a balloon having one portion with a dimeglumine; gadoterate meglumine; gadodiamide; gadot thickness of at most about 0.006 inch, and another portion eridol; gadoversetamide: gadobutrol; gadobenate dimeglu with a thickness of at least about 0.001 inch. When the mine; mangafodipir trisodium; gadoxetic acid, gadobenate balloon is inflated, the relatively thick portion of the balloon dimeglumine; macromolecular Gd-DOTA derivate; gado can experience less overall inflation than the relatively thin benate dimeglumine; gadopentetate dimeglumine; ferric portion of the balloon. The greater extent of inflation of the ammonium citrate; manganese chloride; manganese-loaded relatively thin portion of the balloon can cause the distal Zeolite; ferristene; perfluoro-octylbromide; and barium sul region of the generally tubular member to assume a curved fate. MRI contrast agents are described, for example, in shape. In some embodiments, a balloon having portions with Zhong et al., U.S. Patent Application Publication No. US different thicknesses can be formed using a two-step mold 2004/0186377 A1, published on Sep. 23, 2004, and entitled ing process. First, a balloon mold (in the form of a mandrel) “Medical Devices’, which is incorporated herein by refer is oriented vertically and dipped into a solution of a balloon ence. In some embodiments, one or more therapeutic agents, material, to form a relatively even layer of balloon material Such as one or more of the therapeutic agents described over the mold. The layer of balloon material is then allowed above, can be delivered into the body of a subject using a to dry, and thereafter the mold is rotated into a horizontal balloon catheter. position, and is only partially dipped into the balloon mate 0076. As another example, while the use of a balloon rial solution to form a second layer on a portion of the catheter and embolic material in a portal vein embolization balloon. Once the balloon material has dried, the balloon can procedure has been described, in Some embodiments, a be removed from the mold. balloon catheter and/or embolic material can be used in one 0073. As an additional example, in certain embodiments, or more other procedures. For example, a balloon catheter a catheter can include a balloon having different portions and/or embolic material can be used in a procedure to treat that are formed of different materials. The result can be that one or more sites having cancerous lesions, such as the the different portions of the balloon inflate at different rates breast, prostate, lung, thyroid, or ovaries. A balloon catheter when inflation fluid is added into the balloon. This differ and/or embolic material can be used in, for example, neural, ential inflation can cause the distal region of a generally pulmonary, and/or AAA (abdominal aortic aneurysm) appli tubular member of the catheter to become curved. cations. A balloon catheter and/or embolic material can be 0074 As another example, while particles and gels have used in the treatment of for example, fibroids, tumors, been described as examples of embolic materials, in some internal bleeding, arteriovenous malformations (AVMs), embodiments, one or more other devices and/or materials and/or hypervascular tumors. A balloon catheter and/or can be used to embolize a target site. For example, in some embolic material can be used in, for example, a procedure embodiments, a mixture of N-butyl-2-cyanoacrylate that is used to fill one or more aneurysm sacs, AAA sac (NBCA) ethiodized oil, and/or a mixture of fibrin glue with (Type II endoleaks), endoleak sealants, arterial sealants, ethiodized oil, can be used to embolize a lumen of a subject, and/or puncture Sealants, and/or can be used to provide Such as a branch of a portal vein. In certain embodiments, occlusion of other lumens such as fallopian tubes. Fibroids one or more coils can be used in an embolization procedure. can include uterine fibroids which grow within the uterine In some embodiments, a target site can be embolized using wall (intramural type), on the outside of the uterus (subse particles, and at the end of the embolization procedure, a rosal type), inside the uterine cavity (Submucosal type), relatively small number of coils can be added into the target between the layers of broad ligament Supporting the uterus site. In certain embodiments, the coils can have enhanced (interligamentous type), attached to another organ (parasitic visibility under ultrasound relative to the particles, and can type), or on a mushroom-like Stalk (pedunculated type). be used to determine the location of the embolized region Internal bleeding includes gastrointestinal, urinary, renal and under ultrasound. Coils are described, for example, in Elliott varicose bleeding. AVMs are for example, abnormal collec et al., U.S. patent application Ser. No. 11/000,741, filed on tions of blood vessels (e.g. in the brain) which shunt blood US 2008/0051758 A1 Feb. 28, 2008

from a high pressure artery to a low pressure vein, resulting Some embodiments, a balloon can have a non-spherical in hypoxia and malnutrition of those regions from which the inflated shape. For example, in certain embodiments, a blood is diverted. In certain embodiments, a balloon catheter balloon can have a cylindrical or ellipsoidal inflated shape. and/or embolic material can be used to prophylactically treat The shape of a balloon can be selected, for example, based a condition. on the shape of the region the balloon is designed to treat. 0077. In some embodiments, a catheter including a bal I0081. As a further example, in certain embodiments, a loon can be used in a mitral valve repair procedure. For catheter can include a balloon having multiple (e.g., two, example, in certain embodiments, the balloon can be inflated three, four, five) layers. Balloons with multiple layers are and used to section off a portion of the mitral valve that is described, for example, in Chin et al., U.S. Patent Applica to be treated. In some embodiments, a catheter including a tion Publication No. US 2002/0165523 A1, published on balloon can be used to tighten a mitral valve. In certain Nov. 7, 2002, and entitled “Multilayer Medical Balloon”, embodiments, a balloon that is used in a mitral valve Pierre et al., U.S. Patent Application Publication No. US procedure can have a diameter of at least about 0.5 inch 2004/0078052 A1, published on Apr. 22, 2004, and entitled and/or at most about 0.8 inch. In general, the mitrial valve “Multilayer Medical Device', and Chin et al., U.S. Patent can be entered from below or from above. The distal end of Application Publication No. US 2004/0146670 A1, pub the catheter can be manipulated to a target site where, for lished on Jul. 29, 2004, and entitled “Multilayer Balloon example, a Suturing/stapling device can be passed through, Catheter, each of which is incorporated herein by reference. and secure the tissue to tighten the valve. I0082. As an additional example, while the use of a needle 0078. In certain embodiments, the arithmetic mean diam to temporarily straighten the distal region of a generally eter of particles that are delivered to a subject through a tubular member of a balloon catheter has been described, in balloon catheter can vary depending upon the particular Some embodiments, one or more other devices can alterna condition to be treated. As an example, in certain embodi tively or additionally be used to temporarily straighten the ments in which the particles are used to embolize a liver distal region of a generally tubular member. For example, in tumor, the particles delivered to the subject can have an certain embodiments, a guidewire and/or a stylet can be used arithmetic mean diameter of about 500 microns or less (e.g., to temporarily straighten the distal region of a generally from about 100 microns to about 300 microns; from about tubular member. 300 microns to about 500 microns). As another example, in I0083. As a further example, in some embodiments, a Some embodiments in which the particles are used to embo balloon catheter can be delivered into a target site (e.g., a lize a uterine fibroid, the particles delivered to the subject lumen of a Subject, Such as a portal vein) through an can have an arithmetic mean diameter of about 1,200 introducer sheath. microns or less (e.g., from about 500 microns to about 700 0084 As another example, in certain embodiments, a microns; from about 700 microns to about 900 microns; balloon catheter can be delivered into a target site, and a from about 900 microns to about 1,200 microns). As an microcatheter can then be delivered into a lumen of a additional example, in certain embodiments in which the generally tubular member of the balloon catheter. Thereafter, particles are used to treat a neural condition (e.g., a brain embolic material (e.g., embolic particles) can be delivered tumor) and/or head trauma (e.g., bleeding in the head), the into the target site through the microcatheter. particles delivered to the subject can have an arithmetic I0085. As a further example, while a catheter including a mean diameter of less than about 100 microns (e.g., less than generally tubular member having two lumens has been about 50 microns). As a further example, in some embodi described, in Some embodiments, a catheter can include a ments in which the particles are used to treat a lung generally tubular member having more than two lumens condition, the particles delivered to the subject can have an (e.g., three lumens, four lumens). arithmetic mean diameter of less than about 100 microns I0086. As another example, in some embodiments, a cath (e.g., less than about 50 microns). As another example, in eter can include a generally tubular member having coaxial certain embodiments in which the particles are used to treat lumens. For example, a catheter can include a generally thyroid cancer, the particles can have a diameter of about tubular member having a central lumen and an inflation 1,200 microns or less (e.g., from about 1,000 microns to lumen that are coaxial. about 1,200 microns). I0087 As a further example, in certain embodiments, a 0079. As a further example, in some embodiments, par lumen of a Subject can have a longitudinal axis, and a needle ticles having different shapes, sizes, physical properties, and/or a balloon catheter can be inserted into the lumen at an and/or chemical properties, can be used together in an angle that is not perpendicular to the longitudinal axis. embolization procedure. The different particles can be deliv I0088 As an additional example, while embolic gels ered into the body of a subject in a predetermined sequence including one or more radiopaque materials, MRI-visible or simultaneously. In some embodiments, particles having materials, ferromagnetic materials, and/or contrast agents different shapes and/or sizes can be capable of interacting have been described, in some embodiments, embolic par synergistically (e.g., by engaging or interlocking) to form a ticles and/or coils can include one or more of these mate well-packed occlusion, thereby enhancing embolization. rials. Particles with different shapes, sizes, physical properties, 0089. Other embodiments are in the claims. and/or chemical properties, and methods of embolization using such particles are described, for example, in Bell et al., What is claimed is: U.S. Patent Application Publication No. US 2004/0091543 1. A method, comprising: A1, published on May 13, 2004, and entitled “Embolic delivering a catheter into a lumen of a subject, the catheter Compositions”, and in DiCarlo et al., U.S. Patent Applica comprising: tion Publication No. US 2005/0095428 A1, published on a generally tubular member having a proximal region May 5, 2005, and entitled “Embolic Compositions', both of and a distal region, the generally tubular member which are incorporated herein by reference. defining a lumen, and 0080. As an additional example, while balloons having an inflatable member carried by a portion of the gen generally spherical inflated shapes have been shown, in erally tubular member; US 2008/0051758 A1 Feb. 28, 2008 10

curving the portion of the generally tubular member that 20. The method of claim 19, wherein the method further carries the inflatable member within the lumen of the comprises resecting liver tissue of the Subject. Subject; and 21. The method of claim 1, wherein the lumen of the disposing at least one first embolic material into the lumen Subject defines a longitudinal axis, and delivering the cath of the generally tubular member. eter into the lumen of the Subject comprises inserting the 2. The method of claim 1, wherein the at least one first catheter into the lumen of the Subject along an axis that is embolic material is selected from the group consisting of perpendicular to the longitudinal axis. embolic gels, embolic particles, embolic coils, and combi 22. The method of claim 21, wherein the at least one first nations thereof. embolic material comprises embolic particles. 3. The method of claim 1, wherein the at least one first 23. The method of claim 22, wherein the method further embolic material comprises embolic particles. comprises delivering the at least one first embolic material 4. The method of claim 3, wherein the embolic particles into the lumen of the subject. have an arithmetic mean diameter of about 3,000 microns or 24. The method of claim 1, wherein delivering the cath less. eter into the lumen of the Subject comprises inserting the 5. The method of claim 4, wherein the embolic particles catheter through a first location in skin of the Subject and have an arithmetic mean diameter of about one micron or inserting the catheter through a second location in the lumen O. of the Subject, and the second location is located at most 6. The method of claim 1, wherein the at least one first about three millimeter from the first location. embolic material comprises an embolic gel. 25. The method of claim 1, wherein curving the portion of 7. The method of claim 1, wherein the method further the generally tubular member that carries the inflatable comprises delivering the at least one first embolic material member comprises aligning the portion of the generally into the lumen of the subject. tubular member that carries the inflatable member with a 8. The method of claim 7, wherein the method further longitudinal axis of the lumen of the Subject. comprises rotating the portion of the generally tubular 26. A method, comprising: member that carries the inflatable member within the lumen delivering a catheter into a lumen of a subject, the catheter of the subject. comprising: 9. The method of claim 8, wherein the method further comprises disposing at least one second embolic material a generally tubular member having a proximal region into the lumen of the generally tubular member. and a distal region, the generally tubular member 10. The method of claim 9, wherein the method further defining a lumen, and comprises delivering the at least one second embolic mate an inflatable member carried by a portion of the gen rial into the lumen of the subject. erally tubular member; 11. The method of claim 1, wherein curving the portion of curving the portion of the generally tubular member that the generally tubular member that carries the inflatable carries the inflatable member within the lumen of the member comprises removing an inner member from the Subject; and lumen of the generally tubular member, the inner member flowing at least one contrast agent into the lumen of the being selected from the group consisting of needles, generally tubular member. guidewires, and combinations thereof. 27. A method of resecting liver tissue of a subject, the 12. The method of claim 1, wherein curving the portion of method comprising: the generally tubular member that carries the inflatable delivering a catheter into a lumen of a subject, the catheter member comprises inflating the inflatable member. comprising: 13. The method of claim 1, wherein the inflatable member a generally tubular member having a proximal region has a wall comprising a first region having a first thickness and a distal region, the generally tubular member and a second region having a second thickness that is defining a lumen, and different from the first thickness. an inflatable member carried by a portion of the gen 14. The method of claim 1, wherein the inflatable member erally tubular member; is eccentrically disposed on the portion of the generally inflating the inflatable member within the lumen of the tubular member that carries the inflatable member. Subject; 15. The method of claim 1, wherein the method further curving the portion of the generally tubular member that comprises inflating the inflatable member. carries the inflatable member within the lumen of the 16. The method of claim 15, wherein the method further Subject; comprises delivering the at least one first embolic material into the lumen of the generally tubular member after the disposing embolic particles into the lumen of the gener inflatable member has been inflated. ally tubular member; 17. The method of claim 15, wherein the inflatable delivering the embolic particles into the lumen of the member has a diameter of at least about five millimeters Subject; and when inflated. resecting liver tissue of the Subject. 18. The method of claim 17, wherein the inflatable 28. The method of claim 27, wherein the inflatable member has a diameter of at most about 40 millimeters when member is eccentrically disposed on the portion of the inflated. generally tubular member that carries the inflatable member. 19. The method of claim 1, wherein the lumen of the Subject comprises a branch of a portal vein. k k k k k