Abstract:
According to one embodiment there is disclosed a device including a shield member including an ECM material and a retaining member conformable to maintain at least a portion of the shield member in a desired relationship with respect to an area of a blood vessel to be treated or repaired.

Description:
This application claims the benefit of U.S. Application No. 60/564,541 file Apr. 22, 2004 and the same is hereby incorporated by reference. 
    
    
     BACKGROUND 
     The present invention relates generally to devices, methods and systems for vascular treatment. One embodiment of the present invention relates to a device including an ECM material section and an associated retention member. The ECM material may be placed in a vascular lumen with at least one portion anchored to a vessel. The apparatus can shield a portion of the vessel and also permit further treatment to that or other area(s). While the invention is described with respect to vascular applications, it may also apply to treatment of the hepatic, urinary, respiratory, digestive or reproductive systems, and other anatomical lumen(s), for example. 
     Vascular diseases and disorders are widespread health problems affecting many people. There are many chronic and acute diseases and disorders relating to the vascular system including, for example, thrombosis, embolism, aneurysm, atherosclerosis, arterioschlerosis, infarction and still others. Heart attacks and strokes are leading health concerns. Obstruction of blood flow and/or vessel rupture may cause inadequate blood supply the heart, brain and other parts or all of the body. Occlusive diseases involving constriction, narrowing or obstruction of a blood vessel often present serious possibly life-threatening risks. Additionally, complications in vascular treatment(s) may themselves necessitate further treatment. Some such risks include formation of emboli, vessel damage, thrombogenesis, blood loss, hemorrhage, and others. Furthermore, trauma and other injuries may damage the vascular system and often require repair or replacement. 
     At present, treatment of vascular disease, damage and disorders suffers from limitations, drawbacks and risks. The invention provides unique treatments and solutions to treatment of the foregoing and other problems. 
     SUMMARY 
     According to one embodiment of the present invention there is contemplated a method including introducing a device into an organ, the organ having an interior surface and containing a fluid, shielding at least a portion of the interior surface from the fluid and administering additional treatment to at least the shielded portion. 
     A further embodiment according to the present invention relates to an implantable prosthesis including an ECM material and an anchoring member, wherein the implant is introduceable into a blood vessel in a first state and the anchoring member maintains a portion of the implant in a substantially fixed relationship with the blood vessel in a second state. 
     Yet another embodiment according to the present invention relates to a device including a buffer member adapted to be introduced into a blood vessel to buffer at least a portion of the blood vessel from blood therein, and a retaining member conformable to maintain at least a portion of the buffer member in contact with a portion of the blood vessel. 
     Still a further embodiment according to the present invention includes a treatment system including an intraluminal prosthesis including at least a first portion which is secured relative to a flow in the lumen, a second portion which is capable of movement relative to the first portion in a first state and a treatment device inserted into the lumen and positionable to a location adjacent the prosthesis, the device delivering treatment at about the adjacent location, wherein blood flow is substantially unobstructed by the prosthesis. 
     Yet another embodiment according to the present invention relates to a medical device including a lumen shield of ECM material and an anchor member which is conformable to a retaining position effective to maintain at least a part of the shield in a fixed position with respect to a lumen into which the device has been introduced. 
     Still a further embodiment according to the present invention relates to an apparatus including a tubular piece formed at least in part of an ECM and a stent at least a part of which is affixed to at least a part of the tubular piece wherein the apparatus is sized to permit introduction into a blood vessel in a first state and is conformable to a second state in which it is effective to shield an interior surface of the blood vessel from the blood flowing therethrough. 
     Yet a further embodiment according to the present invention relates to a method of treating disease or damage of a blood vessel including sheltering a portion of a luminal surface of the blood vessel from the blood flow therethrough, administering treatment to the blood vessel, and inducing repair or restoration of the blood vessel with an ECM material. 
     Various embodiments of the present invention provide unique apparatus and methods of treating the vascular system. Still other embodiments, examples and features according to the present invention will be apparent from the following description and claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWING 
         FIG. 1  illustrates a cross section of a stenotic blood vessel. 
         FIG. 2  illustrates  FIGS. 2 and 2A  illustrate a cross section of an apparatus according to embodiments of the present invention in a blood vessel. 
         FIG. 3  illustrates a cross section of the apparatus of  FIG. 2  in another state. 
         FIG. 4  illustrates a cross section of treatment of stenosis according to one embodiment of the present invention. 
         FIG. 5  illustrates a cross section of treatment of stenosis according to one embodiment of the present invention. 
         FIG. 6  illustrates a cross section of an apparatus according to one embodiment of the present invention. 
         FIGS. 7-10  illustrate cross sections of the apparatus of  FIG. 6  in other states. 
     
    
    
     DETAILED DESCRIPTION 
     For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. Nevertheless, no limitation of the scope of the invention is intended. Such alterations and further modifications in the illustrated and described embodiments, and such further applications of the principles of the invention as illustrated therein as would occur to one skilled in the art to which the invention relates are contemplated. 
     With reference to  FIG. 1  there is shown an illustrative view of a blood vessel  110  which includes interior surface  111  and lumen  150 . Blood flow through vessel  110  is generally in the direction indicated by arrow F and may vary according to physiological conditions. Stenosis  113  is a narrowing or constriction of lumen  150  of vessel  110  in the region generally indicated at  112 . The narrowing or constriction of lumen  150  results in reduced blood flow through vessel  110  and increased risk of thrombosis, embolism, and other complications. While stenosis  113  is illustrated, other diseases, damage, or disorders could be present in region  112  or other in other regions. For example, thrombosis, aneurysm, lodged embolism, necrotic tissue, cut or damaged vessel tissue, perforation, and other lesions, disease, disorders or damage including those described above (hereinafter “disease(s)”) may all be treated by the present invention. For the sake of brevity, treatment of stenosis is illustrated and described with the understanding that treatment of the aforementioned diseases and others is also contemplated and protected. Furthermore, it should be understood that the term “vascular” includes, without limitation, the vascular, cardiovascular and/or circulatory systems or portions thereof. Further still, it will be understood that present invention may be applied to still other tubular organs, such as the gall bladder, esophagus, kidney, as well as to organs of the renal, urinary, digestive, alimentary, hepatic, reproductive, respiratory, endocrine and other physiological systems. 
     With reference to  FIG. 2  there is shown an illustrative view of a device  119  according to one embodiment of the present invention which has been placed in lumen  150  of blood vessel  110 . Device  119  includes member  120  and expandable member  130 . Device  119  includes member  120  which extends from distal end  122  to proximal end  123 . Member  120  includes interior surface  121  and lumen  151 . 
     As illustrated in  FIG. 2 , member  120  is tubular, however, in other embodiments member  120  could be partially tubular, a split tube, a coil, a roll, an overlapping tube, a strip, overlapping strips, a ribbon, or a patch to name a few examples. Still other embodiments of the present invention contemplate combinations of these and other structures. 
     Member  120  may include ECM material(s). As used herein, ECM material(s) or extracellular matrix materials refer(s) to a class of biomaterials including, but not limited to, submucosa, mucosa, serosa, pericardium, dermis, fascia, basement membrane, and/or combinations thereof. ECM materials may be derived from various tissue sources including the alimentary, hepatic, respiratory, intestinal, integument, urinary, or genital tracts. ECM materials can be harvested from animals, including, for example, pigs, cattle, sheep, porcine, bovine, ovine or other warm-blooded vertebrates to produce heterologous implants or grafts. Products comprising submucosa tissue derived from porcine small intestine are commercially available ECM materials produced by COOK BIOTECH INCORPORATED of West Lafayette, Ind. 
     Member  120  can comprise any of the aforementioned ECM materials or other ECM materials. Member  120  can also include 1, 2, 3, 4, 5, 6, 7, 8 or more ECM layers. Further, in some embodiments, member  140  can comprise any devitalized or substantially acellular collagenous matrix, naturally-derived or synthetic, and desirably remodelable. The remainder of the text will refer to ECM material unless specifically stated to the contrary. This will not, however, be limiting of the broader aspects of the invention. 
     It is also contemplated that member  120  could also include synthetic polymeric material instead of or in addition to ECM material(s). Such synthetic polymeric materials include, but not limited to polytetrafluoroethylene (“PTFE”) (including expanded PTFE) and/or polyethylene terephthalate (“PET). Further, the synthetic polymer materials can be either a biostable or a bioabsorbable polymer. Bioabsorbable polymers that could be used include, but are not limited to, poly(L-lactic acid), polycaprolactone, poly(lactide-co-glycolide), poly(hydroxybutyrate), poly(hydroxybutyrate-co-valerate), polydioxanone, polyorthoester, polyanhydride, poly(glycolic acid), poly(D,L-lactic acid), poly(glycolic acid-co-trimethylene carbonate), polyhydroxyalkanaates, polyphosphoester, polyphosphoester urethane, poly(amino acids), cyanoacrylates, poly(trimethylene carbonate), poly(iminocarbonate), copoly(ether-esters) (e.g., PEO/PLA), polyalkylene oxalates, and polyphosphazenes. Biostable polymers that could be used include, but are not limited to, polyurethanes, silicones, and polyesters and other polymers such as, but not limited to, polyolefins, polyisobutylene and ethylene-alphaolefin copolymers; acrylic polymers and copolymers, vinyl halide polymers and copolymers, such as polyvinyl chloride; polyvinyl ethers, such as polyvinyl methyl ether; polyvinylidene halides, such as polyvinylidene fluoride and polyvinylidene chloride; polyacrylonitrile, polyvinyl ketones; polyvinyl aromatics, such as polystyrene, polyvinyl esters, such as polyvinyl acetate; copolymers of vinyl monomers with each other and olefins, such as ethylene-methyl methacrylate copolymers, acrylonitrile-styrene copolymers, ABS resins, and ethylene-vinyl acetate copolymers; polyamides, such as Nylon 66 and polycaprolactam; alkyd resins, polycarbonates; polyoxymethylenes; polyimides; polyethers; epoxy resins, polyurethanes; rayon; and rayon-triacetate. The material may be in the form of yarns, fibers, and/or resins, monofilament yarns, high tenacity polyester and others. Further, the present application contemplates other plastic, resin, polymer, woven, and fabric surgical materials, other conventional synthetic surgical materials, and/or combinations of such materials. 
     It will be appreciated that the length, shape, thickness, layers, composition, orientation, other dimensions and attributes of member  120  may be dictated by the desired treatment. Examples of particularized treatment considerations include: a lesion spanning part of or the entire circumference of a vessel calling for a tubular structure, overlapping tube(s), split tube(s), overlapping strips or other circumference spanning configurations. Varying vessel dimensions may also influence attributes of member  120 . For example, an aneurysm may require one or more layers of certain materials to provide adequate strength. The location and nature of vascular disease(s) may also be a factor. Desire for tissue remodeling may suggest use of ECM materials, desire for other characteristics, for example, durability or strength may indicate one or more synthetic materials, and desire for combinations of characteristics may call for hybrid structures. It is also contemplated that member  120  could be one piece, or could include two or more pieces, parts, or units. 
     With continuing reference to  FIG. 2 , retention member  130  contacts the interior of member  120  and extends from outside proximal end  123  of member  120  into member  120 . Member  130  could also extend from farther outside end  123 , from end  123 , or from inside end  123 . In certain embodiments member  130  could extend substantially the length, the entire length, or more than the entire length of member  120 . 
     Member  130  is shown in an expanded configuration in which it can exert bias toward surface  121  of member  120  and maintain a portion of member  120  against interior surface  111  of blood vessel  110 . It is also contemplated that member  130  could contact the interior surface of member  120 , be between two layers of a multi-layer member  120 , embedded within member  120 , attached to the outer surface of member  120 , pierce through member  120 , be coupled to member  120  by intermediate structure, attached to member  120  using additional fasteners, connectors, glue, adhesive, tape, suture, staples, or other structures. 
     Retention member  130  is illustrated as a self-expanding vascular stent but could also be a balloon expandable vascular stent, or any other structure that is not classified as a stent but capable of being introduced into a blood vessel and maintaining at least a portion of member  120  in a desired position or location. Member  130  could be compressible, flexible, bendable, collapsible, rolled, coiled, or twistable, hinged, jointed or otherwise conformable to permit retention of member  120 . Member  120  could also include or consist of barbs or other structures (e.g.  FIG. 2A ) which perforate part or all of member  120  and/or a vascular structure. 
     Member  130  is shown as having a particular braided structure, however, it is contemplated that a wide variety of structures could be used. For example, coil structure(s), spiral structure(s), helical structure(s), woven structure(s), other braided structure(s), ring(s), sinusoidal structure(s), Z-shaped structure(s), zig-zag structure(s), closed cell structure(s), open cell structure(s), and other types of vascular stents are contemplated. Furthermore, the material or materials of member  130  could include stainless steel, tantalum, nitinol, platinum, iridium, polymers, niobium, cobalt, molybdenum, drug eluting coating(s), ECM coating(s) and other materials, alloys, or combinations of the foregoing non-limiting examples. Additionally, it is contemplated that one or more other members could be used at various locations in connection with member  120 , and could be the same, similar to or different from member  130  including, for example, the variations described above. 
     As shown in  FIG. 2 , a portion of member  120  extends beyond member  130  to end  122 . This portion of member  120  is maintained against interior surface  111  by hemostatic pressure. As illustrated, member  120  can conform to the shape of interior  111  as well as to the irregularities presented by stenosis  112 . Hemostatic pressure may be present within member  120  due to the blood flow therethrough, but in the case of trauma or patient and treatment conditions, for example, wide variation in pressure may exist. Blood flow enters member  120  at end  123  and is routed through lumen  151  of member  120  and out of end  122  in the direction generally indicated by arrow F 1 . Thus, blood flow is isolated from stenosis  113  and from portions of interior surface  111 . 
     With reference to  FIG. 3  there is shown an illustrative view of the apparatus and blood vessel described above under different environmental conditions. There are shown various attributes described above in connection with  FIGS. 1 and 2  indicated with identical reference numerals. In  FIG. 3  the fluid or hemostatic pressure of blood in vessel  110  is less than in  FIG. 2  and could be neutral or negative as well. Accordingly, there may be less tendency for member  120  to be maintained against interior surface  111  by hemostatic pressure and a portion of member  120  may move to the position illustrated in  FIG. 3  or to other positions, or might move minimally or substantially not at all. In other embodiments, member  130  could be differently positioned or proportioned to maintain more or less of member  120  against interior surface  111 . In still further embodiments part or all of member  120  need not directly contact the vessel wall, and could be maintained in position by an intermediate structure or structures. Furthermore, in some situations hemostatic pressure and/or properties of member may increase the tendency of member  120  to remain against or adjacent to interior surface  111 . 
       FIGS. 4 and 5  illustrate treatments of stenosis  113 . In  FIG. 4  a dilation balloon  410  has been introduced into blood vessel  110  and advanced to region  112  where it has been expanded as indicated by arrow E. This expansion exerts force on stenosis  113  which causes it to break down. This treatment and others can produce emboli  420  which are fragments of stenosis  113 . Member  120  protects emboli  420  from blood flow and prevents them from entering the bloodstream. 
     As illustrated in  FIG. 5 , vascular stent  510  may be used to reduce stenosis instead of or in addition to dilation balloon  410 . Stent  510  may be any vascular stent or other structure including the examples discussed above. Treatment(s) including multiple stents, interconnected stent, stents which do not touch, stents kept apart by intermediate structures, stent segments, supplemental stents and other structures is also contemplated.  FIG. 5  also shows emboli  520  which are isolated by member  120  from blood flow. 
     Still further treatments are contemplated, for example, administration of drugs, hormones, testing compounds, and other medicaments. Introduction of devices, suturing, anastomosis, cutting, fusing, testing, biopsy, and other operations are also contemplated. Furthermore, laser treatment, heat application, assisted viewing and probing may occur. As used herein “treating” and “treatment(s)” includes, without limitation, the foregoing examples, unless specifically indicated to the contrary. 
     With reference to  FIGS. 6-10  there is illustrated one delivery method and apparatus according to the present invention. Attributes which are the same or similar to those discussed above are indicated with reference numerals which are increased from the 100&#39;s to the 600&#39;s (e.g. 120 becomes 620). It should be understood that delivery of various other embodiments, including those mentioned above, is also contemplated. It should further be understood that the following procedures could be performed in the order listed or in a variety of other orders, for example, deploying an opposite end first, staggered deployment, fluoroscopically aided deployment, and in still other manners.  FIG. 6  shows guidewire  610  which may be any guidewire appropriate for endovascular surgery and may vary according to various treatment indications, including those mentioned above. 
     With continuing reference to  FIG. 6 , tubular member  620  and expandable member  630  are shown compressed about guidewire  610 . Tip  605  may cover a terminal portion of guidewire  610  and an end portion of member  620 . Tip  605  could be a flexible tip, a guiding tip, a cannula or any other tip or tips of differing size, shape and structure. Member  630  and a portion of member  620  are housed within sheath or catheter  640 . Sheath or catheter  640  maintains member  630  in a compressed state in the case of a self-expanding stent, for example. Sheath or catheter  640  could also extend to house more of member  620  and guidewire  610  and could extend even further to house some or all of tip  605 . As a further option, sheath or catheter  640  could have a tip of its own, for example, a nose cone. In still other embodiments tip  605  may not be present and member  620  could be maintained in place by a dissolvable adhesive, by a low profile removable wrap or other structure, or could be compressed about guidewire  610  where exposure to liquid, e.g. blood, was limited or eliminated until deployment was desired. 
     With reference to  FIGS. 7 and 8  there is illustrated an example of deployment of member  630  and one end of member  620 . In  FIG. 7  catheter or sheath  640  has been moved relative members  620  and  630 . This can be accomplished by advancing guidewire  610  in the direction indicated by arrow G effective to move members  620  and  630  in the same direction, by retracting catheter or sheath  640  in the direction indicted by arrow C, or by a combination of both movements. Other deployment techniques and devices are also contemplated. For example, one or more additional wires, sheaths, catheters, snares, pushers, dilation balloons, or other structures which could move members  620  and  630  and/or catheter or sheath  640  are contemplated. 
     Regardless of which deployment mode is used, member  630  can expand as it exits catheter or sheath  640 . This expansion also causes member  620  to expand with member  630 .  FIG. 8  illustrates member  630  after it has completely exited catheter or sheath  640  and is fully expanded. In vivo, member  630  can maintain member  620  against the interior surface of a blood vessel as was described above or in another desired position or location. 
     With reference to  FIGS. 9 and 10  there is illustrated deployment of the opposite end of member  620 . In  FIG. 9 , guidewire  610  has been advanced in the direction indicated by arrow T which is effective to move tip  605  in the same direction. During this movement, members  620  and  630  can be maintained in place by force exerted by member  630  against the interior wall of a blood vessel. The result of this movement is shown in  FIG. 10  where tip  605  has been advanced completely off of end  622  of member  620  allowing expansion of end  622 . Once members  620  and  630  are in the configuration shown in  FIG. 10 , blood flow can be routed through member  620  to expand member  620  as described above and illustrated in connection with  FIGS. 2 and 3 . Additional deployment modes for the opposite end of member  620  are also contemplated including, for example, those discussed above. 
     While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected. It should be understood that while features described above may be desirable, they nonetheless may not be necessary and embodiments lacking the same may be contemplated as within the scope of the invention, that scope being defined by the claims that follow. In reading the claims it is intended that when words such as “a,” “an,” “at least one,” “a portion,” “at least a portion” are used there is no intention to limit the claim to only one item unless specifically stated to the contrary in the claim. Further, when the language “at least a portion” and/or “a portion” is used the item may include a portion and/or the entire item unless specifically stated to the contrary.