Patent Publication Number: US-2021170146-A1

Title: Vascular occlusion and drug delivery devices, systems, and methods

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This Patent Application claims priority to and the benefit of Provisional Patent Application Ser. No. 61/660,615, entitled VASCULAR OCCLUSION AND DRUG DELIVERY DEVICES, SYSTEMS, AND METHODS, filed Jun. 15, 2012, which is incorporated by reference herein in its entirety. 
    
    
     BACKGROUND 
     Field 
     The present disclosure relates to occlusion and drug delivery devices, systems, and methods. Such devices and methods can be useful for tissue ablation, tissue and/or vascular drug delivery, and temporary and/or permanent vessel occlusion. 
     Discussion of the Related Art 
     The systemic administration of therapeutic agents treats the body as a whole even though the disease to be treated may be localized. In some cases of localized condition or disease, systemic administration may not be desirable because the drug agents may have deleterious or unwanted effects on parts of the body which are not to be treated or because treatment of the diseased part of the body requires a high concentration of drug agent that may not be achievable by systemic administration. It is therefore often desirable to administer therapeutic agents to only localized sites within the body. Common examples of where this is needed include cases of localized disease (e.g., heart disease and saphenous vein incompetence) and occlusions or lesions in body lumens. Several devices and methods for localized drug delivery are known. 
     Typically, with these types of treatments, an elongate member, such as a catheter, traverses the vasculature with a drug containing device mounted on the end. Once the target area is reached, the drug containing device delivers the drug. While the specifics of the drug containing device and the mode of delivery can vary, the problems encountered with these devices are usually the same. 
     Some of the problems encountered include dilution of the therapeutic agent with body fluids, migration away from the treatment area, and adverse effects caused by the migration. For example, in a method of treating an incompetent saphenous vein, chemical ablation involves treating the target vessel with a sclerosant that actually injures the contacted tissue. As expected by its effect, sclerosants are highly toxic and thus migration should be avoided to the extent possible to minimize unwanted side effects. Sclerosant migration through the vasculature has been linked with deep venous thrombosis, pulmonary embolism, ulceration and neurological events such as migraines, transient ischemic attacks and cerebrovascular accidents. In addition, sclerosants can have a high price per unit, so minimizing the amount utilized to effect treatment is also desirable. 
     Complicating the ability of designing drug delivery devices and modes of treatment that minimize the issues discussed above is the tortuosity of the vessel, both traversing a tortuous, narrow vessel and treating a tortuous section of a vessel. For example, tortuosity often occurs in the Greater Saphenous Vein (GSV) and can pose difficulty. In the case of the GSV, the treatment site may be, for example, 30-40 cm or more of a tortuous vein. 
     As can be appreciated by the example of saphenous vein sclerotherapy, improvements in vascular drug delivery that improve delivery rates or efficacy, minimize dilution, and/or minimize migration are desired. 
     SUMMARY 
     The present disclosure is directed to devices and methods for use in connection with drug delivery and/or vessel occlusion, useful in the treatment of numerous conditions, such as saphenous vein incompetency. Disclosed devices can be operable for providing close proximity to a surrounding tissue defining a lumen along a length of the device and further, applying a therapeutic agent, to the surrounding tissue along this length. Stated differently, the therapeutic agent can be intimately applied to at least a majority portion of the surrounding tissue along this length. 
     Additionally, disclosed devices can displace at least a portion of a fluid, such as blood, along the length of a vessel and thus, substantially occlude the vessel along this length. In effect, the close proximity to the surrounding tissue and the displacement of blood can reduce the amount of therapeutic agent required for an effective treatment as well as the amount of therapeutic agent migrating away from the treatment site. 
     In accordance with an aspect of the present disclosure, drug delivery and/or occlusion devices and methods comprise an expandable member and a drug delivery component that facilitate the application of a therapeutic agent to a surrounding tissue defining a lumen along a length. In some embodiments, a device is operable to evert and thereby extend along the length of the vessel to be treated. Once in position, a device can be operable to deliver a therapeutic agent to the surrounding tissue, upon pressurization of the expandable member at pressures less than 20 psi. The drug delivery component can be infused with a therapeutic agent, while located in the vasculature prior to pressurization, or in some embodiments, the drug delivers component can be infused or imbibed with a therapeutic agent prior to the introduction of the device into the vasculature. Once therapeutic agent has been transferred to the surrounding tissue, the expandable member is collapsed and then the expandable member and the drug delivery component are retracted. 
     In accordance with another aspect of the disclosure, drug delivery and/or occlusion devices and methods can comprise a bioabsorbable, lumen-occluding implant (bioabsorbable implant) member. Bioabsorbable implants can have an occlusive or flow stasis effect and also contribute to augment healing. Embodiments can be implanted via an implantation guide, such as a hollow needle or catheter, into the lumen of a vessel or into a tissue or body cavity. In some embodiments, the bioabsorbable, implant can be extended and retracted on demand to adjust the position of the bioabsorbable implant. In some embodiments, the bioabsorbable implant can be anchorable. In some embodiments, the bioabsorbable implant can have a narrow delivery profile and a wider implantation profile. 
     Bioabsorbable implant embodiments can further be imbibed with a therapeutic agent. The same or different embodiments can be configured to cause a thrombogenic response and/or a spasmodic response to have an occlusive effect. In some embodiments, imbibing can be performed on demand, e.g., with the use of a pressurizable capsule. The pressurizable capsule or other imbibing mode can be integrated into the delivery device. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure, and together with the description serve to explain the principles of the disclosure, wherein: 
         FIG. 1A  illustrates a top view of a hub comprising an expansion port, an infusion port, and a ventilation port; 
         FIG. 1B  illustrates a perspective, schematic view of a vascular drug delivery device; 
         FIG. 2A  illustrates a layered, cross-sectional view of a vascular drug delivery device; 
         FIG. 2B  illustrates a layered, cross-sectional view of a vascular drug delivery device; 
         FIG. 2C  illustrates side views of a vascular drug delivery device embodiment inserted into lumen of a vessel at a reduced pressure for drug infusion and at an increased pressure for drug delivery; 
         FIG. 2D  illustrates side views of a vascular drug delivery device embodiment retracted within lumen of elongate member and then extending outward as the expandable member is pressurized; 
         FIG. 2E  illustrates a side view of a vascular drug delivery device embodiment configured to traverse along a guidewire; 
         FIG. 2F  illustrates a side view of a non-everting vascular drug delivery device embodiment mounted on the end of elongate member; 
         FIGS. 2G-1 to 2G-2  provide two variously scaled illustrations of a porous microstructure suitable for use in the drug infusible layer; 
         FIG. 3A  illustrates an occluding device embodiment; 
         FIG. 3B  illustrates a cross-sectional view of a pre-loaded delivery capsule embodiment; 
         FIG. 3C-1  to  FIG. 3C-5  illustrate the steps of implanting an occluding device embodiment into a vessel; 
         FIG. 4A-1  illustrates an occluding device embodiment; 
         FIG. 4A-2  illustrates an occluding device embodiment during release from a implantation guide; 
         FIG. 4B-1  illustrates a proximal end of an occluding device embodiment inserted into a distal end of an implantation piston member embodiment; 
         FIG. 4B-2  illustrates the control end of a delivery device embodiment; 
         FIGS. 4C-1 and 4C-2  illustrate a distal end of a delivery device embodiment comprising a cutter mechanism; 
         FIG. 5A-1  illustrates a first component of a bioabsorbable implant embodiment delivered to a treatment site via a guidewire; 
         FIGS. 5A-2 and 5A-3  illustrates a implantation guide inserted into the first component of the bioabsorbable implant; and 
         FIGS. 5A-4 and 5A-5  illustrate an implantation guide injecting the second component of bioabsorbable implant into the first component of the bioabsorbable implant. 
     
    
    
     DETAILED DESCRIPTION 
     Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatuses capable of performing the intended functions. Stated differently, other methods and apparatuses can be incorporated herein to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not all drawn to scale, but can be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting. 
     Although the present disclosure can be described in connection with various principles and beliefs, the present disclosure should not be bound by theory. For example, the present disclosure can be described herein in connection with occlusion and drug delivery in the context of the vasculature. However, the present disclosure can be applied toward any space-filling and/or chemical agent delivery devices or methods of similar structure and/or function. Furthermore, the present disclosure can be applied in nonvascular applications and even non-biologic and/or non-medical applications. 
     The terms “proximal” and “distal,” when used herein in relation to a device or device component refer to directions closer to and farther away from the operator of the device, respectively. Since the present disclosure is not limited to peripheral or central approaches, the device should not be narrowly construed when using the terms proximal or distal since device features can be slightly altered relative to the anatomical features and the device position relative thereto. 
     The term “lumen” or “body lumen”, as used herein in the context of the treatment site, comprises any vessel lumen or body cavity. “Vessel,” as used herein, can include an artery or vein or any other body conduit such as a gastro-intestinal tract, fallopian tube, or the like. 
     The term “infuse” as used herein, refers to spreading over, through, or in between something, and includes to permeate, fill, suffuse, infuse, or the like. Similarly, the term “infusible” as used herein, refers to the ability to be infused. Embodiments described herein can be infused with a therapeutic agent for purposes of applying the therapeutic agent to a surrounding area or tissue. 
     The term “imbibe” as used herein, refers to absorbing, saturating, bonding, and/or coating something. Embodiments described herein can be imbibed with a therapeutic agent for purposes of applying the therapeutic agent to a surrounding tissue. 
     The term “permeability” as used herein, refers to the ability to transmit fluids (liquid or gas) through the pores of a membrane or filter material when the material is subjected to a differential pressure across it. Permeability can be characterized by Gurley number, Frazier number, or water flux rate. Embodiments described herein can be configured to transmit a fluid at low differential pressures. 
     The term “bioabsorbable” or “absorption” refers to the physiological process in which at least a portion of a material hydrolyzes, degrades, dissolves, absorbs, resorbs, or otherwise assimilates into the body. 
     The term “therapeutic agent” or “drug” as used herein, refers to any substance that aids in any procedure, e.g., diagnostic or therapeutic procedures, or that aids in providing a therapeutic and/or curative effect. 
     Such agents include, but are not limited to, sclerosants, such as polidocanol (Aethoxysklerol), sodium teradecylsuflate (STS, Sotradecol), ethanolamine oleate (ethamolin), Sodium morrhuate (Scleromate), concentrated ethanol (&gt;90%), concentrated phenol (˜3%), hypertonic saline, hypertonic dextrose solutions (e.g. Sclerodex® produced by Omega Laboratories), chromated glycerin (Sklermo® or Chromex®), and glycerin-based sclerosants; anti-thrombotic agents such as heparin, heparin derivatives (low molecular weight heparins, danaparoid, and fondaparinux), thrombolytics (urokinase, etc.), and dextrophenylalanine proline arginine, chloromethylketone, Coumadin, Coumarin, and direct thrombin inhibitors such as argatroban; anti-inflammatory agents such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine and mesalamine, sirolimus and everolimus (and related analogs), anti-neoplastic/antiproliferative/antimiotic agents such as paclitaxel and analogues thereof, paclitaxel protein-bound particles such as ABRAXANE® (ABRAXANE is a registered trademark of ABRAXIS BIOSCENCE, LLC), paclitaxel complexed with an appropriate cyclodexdrin (or cyclodextrin like molecule), rapamycin and analogues thereof, rapamycin (or rapamycin analogs) complexed with an appropriate cyclodexdrin (or cyclocdextrin like molecule), beta-lapachone and analogues thereof, 5-fluorouracil, cisplatin, vinblastine, vincristine, opothilones, endostatin, angiostatin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, and thymidine kinase inhibitors; anesthetic agents such as lidocaine, bupivacaine and ropivacaine; anti-coagulants such as D-Phe-Pro-Arg chloromethyl ketone, an RGD peptide containing compound, AZX1 00 a cell peptide that mimics HSP20 (Capstone Therapeutics Corp., USA), heparin, hirudin, antithrombin compounds, platelet receptor antagonists, anti-thrombin antibodies, anti-platelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors and tick antiplatelet peptides; vascular cell growth promoters such as growth factors, transcriptional activators, and translational promotors; vascular cell growth inhibitors such as growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies directed against growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin, bifunctional molecules consisting of an antibody and a cytotoxin; protein kinase and tyrosine kinase inhibitors (e.g., tyrphostins, genistein, quinoxalines); prostacyclin analogs; cholesterol-lowering agents; angiopoietins; antimicrobial agents such as triclosan, cephalosporins, aminoglycosides and nitrofurantoin; cytotoxic agents, cytostatic agents and cell proliferation affectors; vasodilating agents; agents that interfere with endogenous vasoactive mechanisms; inhibitors of leukocyte recruitment, such as monoclonal antibodies; cytokines; hormones or a combination thereof. In an embodiment, therapeutic agent can comprise a biocompatible glue or tissue adhesive. Similarly, a therapeutic agent can comprise pro-coagulants, such as fibrin glue and/or thrombin administration. In one embodiment, said therapeutic agent is a hydrophilic agent. In another embodiment, said therapeutic agent is a hydrophobic agent. In another embodiment, said therapeutic agent is paclitaxel. 
     The therapeutic agents useful in conjunction with the present disclosure can be delivered to the tissue in various physical forms, including but not limited to nanospheres, microspheres, nanoparticles, microparticles, crystallites, inclusion complexes, emulsions, gels, foams, creams, suspensions, and solutions or any combination thereof. In one embodiment, the agent is delivered to the tissue in a solubilized form. In another embodiment, the agent is delivered to the tissue in a gel. 
     The present disclosure is directed to devices and methods for use in connection with drug delivery and/or vessel occlusion, useful in the treatment of numerous conditions, such as saphenous vein incompetency. Disclosed devices can be operable for providing close proximity to a surrounding tissue defining a lumen along a length of the device and applying a therapeutic agent, to the surrounding tissue along this length. For example, the therapeutic agent can be intimately applied to at least a majority portion of the surrounding tissue along this length. 
     Additionally, disclosed devices can displace at least a portion of a fluid, such as blood, along the length of a vessel and thus, substantially occlude the vessel along this length. In effect, the close proximity to the surrounding tissue and the displacement of blood can reduce the amount of therapeutic agent required for an effective treatment as well as the amount of therapeutic agent migrating away from the treatment site. 
     In accordance with an aspect of the present disclosure, drug delivery and/or occlusion devices and methods comprise an expandable member and a drug delivery component that facilitate the application of a therapeutic agent to a surrounding tissue defining a lumen along a length. In some embodiments, a device is operable to evert and thereby extend along the length of the vessel to be treated. Once in position, a device can be operable to deliver a therapeutic agent to the surrounding tissue, upon pressurization of the expandable member at pressures less than 20 psi. The drug delivery component can be infused with a therapeutic agent, while located in the vasculature prior to pressurization, or in some embodiments, the drug delivery component can be infused or imbibed with a therapeutic agent prior to the introduction of the device into the vasculature. Once therapeutic agent has been transferred to the surrounding tissue, the expandable member is collapsed and then the expandable member and the drug delivery component are retracted. 
     In accordance with another aspect of the disclosure, drug delivery and/or occlusion devices and methods can comprise a bioabsorbable, lumen-occluding implant (bioabsorbable implant) member. Bioabsorbable implants can have an occlusive or flow stasis effect and also contribute to augment healing. Embodiments can be implanted via an implantation guide, such as a hollow needle or catheter, into the lumen of a vessel or into a tissue or body cavity. In some embodiments, the bioabsorbable, implant can be extended and retracted on demand to adjust the position of the bioabsorbable implant. In some embodiments, the bioabsorbable implant can be anchorable. In some embodiments, the bioabsorbable implant can have a narrow delivery profile and a wider implantation profile. 
     Bioabsorbable implant embodiments can further be imbibed with a therapeutic agent. The same or different embodiments can be configured to cause a thrombogenic response and/or a spasmodic response to have an occlusive effect. In some embodiments, imbibing can be performed on demand, e.g., with the use of a pressurizable capsule. The pressurizable capsule or other imbibing mode can be integrated into the delivery device. 
     With reference to  FIGS. 1A and 1B , in accordance with various embodiments, a vascular drug delivery device  100  can comprise an inner expandable member  110  and an outer drug delivery component  120 , inner and outer being in reference to the relative location when device  100  is in an extended configuration. In such configuration, drug delivery component  120  can circumscribe or be mounted around at least a portion of the length of the expandable member  110 . 
     Drug delivery component  120  is any structural component suitable for transferring a therapeutic agent from component to a surrounding tissue that defines a lumen. Drug delivery component  120  is configured to be in close proximity to the surrounding tissue along a length of device  100  and permit application of a therapeutic agent to the surrounding tissue along this length. In an embodiment, drug delivery component  120  can intimately transfer a therapeutic agent to at least a majority portion of the surrounding tissue along this length. In some embodiments, drug delivery component  120  can be imbibed or infused with a therapeutic agent. 
     Expandable member  110  is any structural component or material suitable for expanding into close proximity to the surrounding tissue along a length of the device. For example, expandable member  110  can be an inflatable device, such as a balloon wherein an inflation medium can be a fluid, such as a saline solution, contrast agent, or any other flowable material. 
     Expandable member  110  can be mounted to the distal end of an elongate member  130 . Elongate member  130  is any structural component suitable for traversing the vasculature and having a distal and a proximal end with at least one lumen there through. For example, elongate member  130  can comprise a catheter or a plurality of catheters. In other embodiments, elongate member  130  can comprise a needle, e.g. a hypodermic needle. Elongate member  130  can be rigid or flexible. 
     In an embodiment, elongate member  130 , as used herein, comprises an expandable lumen for purposes of expanding, inflating and/or everting expandable member. Elongate member  130  can also comprise an infusion lumen for purposes of infusing drug delivery component  120  with a fluid and ventilating drug delivery component  120 . Elongate member can further comprise a ventilation lumen can be useful to purge air in drug delivery component  120  and to indicate to a clinician when a drug delivery component  120  has been infused. Elongate member  130  can be configured to be bendable to traverse through tortuous vasculature, and can further be configured to minimize or eliminate kinking. Elongate member  130  can comprise an inner diameter of sufficient size to permit passage of an inflation medium. Elongate member  130  can comprise any medical-grade material. Elongate member  130  can comprise polymeric or metallic materials or combinations thereof. For example, elongate member  130  can comprise a polymeric film tube with spiral or braided nitinol reinforcements. 
     Typical materials used to construct elongate member  130  can comprise commonly known materials such as Amorphous Commodity Thermoplastics that include Polymethyl Methacrylate (PMMA or Acrylic), Polystyrene (PS), Acrylonitrile Butadiene Styrene (ABS), Polyvinyl Chloride (PVC), Modified Polyethylene Terephthalate Glycol (PETG), Cellulose Acetate Butyrate (CAB); Semi-Crystalline Commodity Plastics that include Polyethylene (PE), High Density Polyethylene (HDPE), Low Density Polyethylene (LDPE or LLDPE), Polypropylene (PP), Polymethylpentene (PMP); Amorphous Engineering Thermoplastics that include Polycarbonate (PC), Polyphenylene Oxide (PPO), Modified Polyphomylene Oxide (Mod PPO), Polyphenylene Ether (PPE), Modified Polyphenylene Ether (Mod PPE), Thermoplastic Polyurethane (TPU); Semi-Crystalline Engineering Thermoplastics that include Polyamide (PA or Nylon), Polyoxymethylene (POM or Acetal), Polyethylene Terephthalate (PET, Thermoplastic Polyester), Polybutylene Terephthalate (PBT, Thermoplastic Polyester), Ultra High Molecular Weight Polyethylene (UHMW-PE); High Performance Thermoplastics that include Polyimide (PI, Imidized Plastic), Polyamide Imide (PAI, Imidized Plastic), Polybenzimidazole (PBI, Imidized Plastic); Amorphous High Performance Thermoplastics that include Polysulfone (PSU), Polyetherimide (PEI), Polyether Sulfone (PES), Polyaryl Sulfone (PAS); Semi-Crystalline High Performance Thermoplastics that include Polyphenylene Sulfide (PPS), Polyetheretherketone (PEEK); and Semi-Crystalline High Performance Thermoplastics, Fluoropolymers that include Fluorinated Ethylene Propylene (FEP), Ethylene Chlorotrifluroethylene (ECTFE), Ethylene, Ethylene Tetrafluoroethylene (ETFE), Polychlortrifluoroethylene (PCTFE), Polytetrafluoroethylene (PTFE), expanded Polytetrafluoroethylene (ePTFE), Polyvinylidene Fluoride (PVDF), Perfluoroalkoxy (PFA). Other commonly known medical grade materials include elastomeric organosilicon polymers, polyether block amide or thermoplastic copolyether (PEBAX) and metals such as stainless steel and nickel/titanium alloys. 
     At the proximal end of elongate member  130 , a hub  140  can be coupled thereto. Hub  140  can comprise any structural component suitable for facilitating introduction of an inflation medium into expandable member  110 . For example, hub  140  can comprise an expansion port  141  in fluid communication with expandable member  110  via expansion lumen. In addition, in some infusible embodiments, hub  140  can further be configured to facilitate infusion and/or ventilation of drug delivery component  120 . For example, hub  140  can comprise an infusion port  142  in fluid communication with drug delivery component  120  via an infusion lumen, and a ventilation port  143  in fluid communication with drug delivery component  120  via a ventilation lumen. 
     In an embodiment, with reference to  FIGS. 2A to 2F , vascular drug delivery device  200  can comprise expandable member  210  and drug delivery component  220 . Drug delivery component  220  can circumscribe, be situated about, and/or be mounted around inner expandable member  210 . Drug delivery component  220  can be configured to deliver a therapeutic agent upon pressurization of the expandable member  210  to a pressure less than about 3 to about 20 psi. Drug delivery component  220  can be configured to be infused with a therapeutic agent, and can further be configured to be ventilated via a ventilation port. In some embodiments, device  200  can be configured to evert into position. 
     Expandable member  210  can comprise any inflatable device. Expandable member  210  can be any shape suitable to expand and substantially occupy the lumen at the treatment site. Expandable member  210  can be a generally compliant and/or bendable material to facilitate substantially occupying the vessel lumen along a length and further to enable reversion and expansion at low pressures, e.g., pressures about of 1 per to about 10 psi above the ambient pressure. In an embodiment, expandable member  210  can have a generally tubular shape. 
     In addition, in various embodiments, expandable members can also be radially compliant thereby permitting device  200  being capable of expanding into a range of diameters. In addition, expandable members can be radially compliant across a length. In the instance of treating the entire length of a tapered lumen, as is often the case for the greater saphenous vein, device  200  can be capable of treating a lumen that varies in diameter across its length by about 5 mm, about 10mm, or about 15 mm. For example, device  200  can treat a lumen that tapers from a diameter of about 10 mm to a diameter of about 5 mm. 
     In some embodiments, expandable member  210  can be liquid-tight or impermeable. In this manner, the lumen of expandable member  210  is not in fluid communication with drug infusible layer. In other embodiments, expandable member  210  can be permeable and/or be configured to permit a fluid to weep to its outer surface. The fluid weep-ability can facilitate the transfer of a therapeutic agent, e.g., by solvating or diluting the therapeutic agent. 
     In some embodiments, expandable member  210  can comprise a balloon. Balloon formation can be carried out in any conventional manner using known extrusion, blow molding and other molding techniques. Typically, three major steps in the process include extruding a tubular preform, molding the balloon and annealing the balloon. Depending on the balloon material employed, the preform can be axially stretched before it is blown. Techniques for balloon formation are described in U.S. Pat. Nos. 4,490,421 to Levy; RE32,983 to Levy; RE33,561 to Levy; and U.S. Pat. No. 5,348,538 to Wang et al., which are hereby incorporated by reference in their entireties. 
     The balloon can be attached to elongate member  230  by various bonding techniques known to the skilled artisan. Examples include, but are not limited to, solvent bonding, thermal adhesive bonding and heat shrinking or sealing. The selection of the bonding technique is dependent upon the materials from which the expandable element and tubular body are prepared. Refer to U.S. Pat. No. 7,048,713 to Wang, all of which is hereby incorporated by reference in its entirety. 
     According to the present disclosure, the balloon can be formed using any materials known to those of skill in the art with the desired physical properties. Commonly employed materials include the thermoplastic elastomeric and non-elastomeric polymers and the thermosets. 
     In various embodiments configured to evert, a thin, strong and impermeable version of PTFE membrane is useful because PTFE membranes possess a low coefficient of friction, are strong, and are very flexible, allowing device  200  to turn upon itself while everting. Expandable members made of PTFE can also be radially compliant. 
     Examples of suitable materials include but are not limited to, polyolefins, polyesters, polyurethanes, polyamides, polyether block amides, polyimides, polycarbonates, polyphenylene sulfides, polyphenylene oxides, polyethers, silicones, polycarbonates, styrenic polymers, copolymers thereof, and mixtures thereof. Some of these classes are available both as thermosets and as thermoplastic polymers. For example, see U.S. Pat. No. 5,500,181, to Wang et al., which is hereby incorporated by reference, in its entirety. As used herein, the term “copolymer” shall be used to refer to any polymer formed from two or more monomers, e.g. 2, 3, 4, 5 and so on and so forth. 
     Useful polyamides include, but are not limited to, nylon 12, nylon 11, nylon 9, nylon 6/9 and nylon 6/6. The use of such materials is described in U.S. Pat. No. 4,906,244 to Pinchuk et al., for example, which is hereby incorporated by reference in its entirety. Examples of some copolymers of such materials include the polyether-block-amides, available from Elf Atochem North America in Philadelphia, Pa. under the tradename of PEBAX®. Another suitable copolymer is a polyetheresteramide materials available for use are vast and too numerous to be listed herein and are known to those of ordinary skill in the art. 
     Suitable polyester copolymers, include, for example, polyethyelene terephthalate and polybutylene terephthalate, polyester ethers and polyester elastomer copolymers such as those available from DuPont in Wilmington, Del. under the tradename of HYTREL®. 
     Block copolymer elastomers such as those copolymers having styrene end blocks, and midblocks formed from butadiene, isoprene, ethylene/butylene, ethylene/propene, and so forth can be employed herein. Other styrenic block copolymers include acrylonitrile-styrene and acrylonitrile-butadienestyrene block copolymers. Also, block copolymers wherein the particular block copolymer thermoplastic elastomers in which the block copolymer is made up of hard segments of polyester or polyamide and soft segments of polyether can also be employed herein. Specific examples of polyester/polyether block copolymers are poly(butylene terephthalate)-block-poly(tetramethylene oxide) polymers such as ARNITEL® EM 740, available from DSM Engineering Plastics and HYTREL® polymers available from DuPont de Nemours &amp; Co, already mentioned above. 
     Suitable materials which can be employed in balloon formation are further described in, for example, U.S. Pat. No. 6,406,457 to Wang et al.; U.S. Pat. No. 6,284,333 to Wang et al.; U.S. Pat. No. 6,171,278 to Wang et al.; U.S. Pat. No. 6,146,356 to Wang et al.; U.S. Pat. No. 5,951,941 to Wang et al.; U.S. Pat. No. 5,830,182 to Wang et al.; U.S. Pat. No. 5,556,383 to Wang et al.; U.S. Pat. No. 5,447,497 to Sogard et al.; U.S. Pat. No. 5,403,340 to Wang et al.; U.S. Pat. No. 5,348,538 to Wang et al.; and U.S. Pat. No. 5,330,428 to Wang et al., all of which are hereby incorporated by reference in their entireties. 
     The above materials are intended for illustrative purposes only, and not as a limitation on the scope of the present disclosure. Suitable polymeric materials available for use are vast and too numerous to be listed herein and are known to those of ordinary skill in the art. 
     In various embodiments, vascular drug delivery device  200  can comprise an inner expandable member  210  and an outer drug deliver component  220  wherein the drug delivery component  220  comprises a drug infusible layer  221  located on the outer surface of expandable member  210 . Drug infusible layer  221  can be infused via infusion lumen  222 . In accordance with specific embodiments, no therapeutic agent is present in drug delivery component  220  until drug delivery component  220  is in position for treatment. Once in position, a therapeutic agent can then be infused into drug delivery component  220 . In addition to, drug delivery component  220  can comprise an outer barrier  225 . Outer barrier  225  circumscribes, is mounted around, or is situated about infusible layer  221  and prevents the macroscopic transfer of a therapeutic agent until re-expansion of expandable member  210 . Outer barrier  225  is described in further detail below. 
     In various embodiments, drug delivery component  220  can be configured to customize the amount of therapeutic agent released per unit area. For example, the infusion volume and/or saturation capabilities can be varied by varying the thickness and/or distensibility of infusible layer  221  and/or by selecting infusible layer  221  materials with desired saturation properties. In this manner, the therapeutic agent release volumes can be tailored. By tailoring to utilize an effective but minimum amount of therapeutic agent, costs as well as unwanted secondary effects could potentially be reduced. 
     In an embodiment, with reference to  FIG. 2A , infusible layer  221  can comprise any material or structural configuration which facilitates distribution of a therapeutic agent throughout a majority or substantial portion of infusible layer  221 . For example, infusible layer  221  can comprise a wicking material, a porous wall or layer, and/or a material that provides sufficiently low resistance to fluid flow. In addition, infusible layer can comprises a sufficiently crush resistant material so that it does not kink when extended across a tortuous vasculature. In an embodiment, infusible layer  221  can comprise a highly nodal, low-density or open pore membrane of PTFE such as that described in U.S. Pat. No. 5,814,405 by Branca et al. entitled “Strong, Air Permeable Membranes of Polytetrafluroethylene,” which is hereby incorporated by reference in its entirety.  FIGS. 2G-1 to 2G-2  illustrate a porous microstructure (at two scales of magnification) suitable for use in drug infusible layer  221 . Other suitable materials can include open cell polyurethane foam, open cell silicone foam, open cell fluoropolymers, or any other pliable materials comprising micro or macro channels to allow infusion. 
     The material(s) utilized in infusible layer  221  can also be surface treated to vary the hydrophobic or hydrophilic properties of infusible layer  221 . Such treatments can vary based on the therapeutic agent to be infused. In an embodiment, infusible layer  221  comprising ePTFE can be coated with polyvinylalcohol (PVA) to render layer  221  more hydrophilic. 
     In various embodiments, with reference to  FIG. 2B , infusible layer  221  can comprise a film-like sleeve circumscribing the expandable member  210  and defining at least a portion of interstitial space, such interstitial space being the region to be at least partially filled with a therapeutic agent. To facilitate distribution of a therapeutic agent, an infusible layer  221  can comprise at least one seam  224  or a plurality of seams  224  which outlines an infusion path. In an embodiment, seam  224  can be a spiral shape. In other embodiments, drug infusible layer can comprise a plurality of seams  224  arranged in a substantially parallel manner. 
     In order to infuse, again with reference to both  FIGS. 2A and 2B , device  200  can comprise an infusion lumen  222  that transports a therapeutic agent to infusible layer  221  via an inflation port. In order to ensure and facilitate distribution, drug delivery component  220  can further comprise a ventilation lumen  223 , also in fluid communication with infusible layer  221 . 
     Infusion lumen  222  and ventilation lumen  223  can be in fluid communication with infusible layer  221  at any location on infusible layer  221 . In an embodiment, infusion lumen  222  is in fluid communication on a proximal end and ventilation lumen  223  is in fluid communication on a distal end, or vice versa. Embodiments can also comprise infusion lumen  222  in fluid communication at a first end of an infusion path and ventilation lumen  223  in fluid communication at a second end of the infusion path. 
     In an embodiment, infusion can occur prior to or after expansion of expandable member  210 . Infusing while expandable member  210  is at a minimal or negligible pressure can enhance the degree of distribution of the therapeutic agent throughout infusible layer  221 . Once infused, expandable member  210  can be expanded to occupy the lumen and facilitate the transfer of the therapeutic agent. 
     In addition, as referenced above, drug delivery component  220  can comprise outer barrier  225 . Outer barrier  225  can partially or substantially block the transfer of an infused therapeutic agent until drug delivery component  220  is approaching or in close proximity to the surrounding tissue. In some embodiments, drug delivery component  220  can be configured to transfer the therapeutic agent across outer barrier  225  once expandable member  210  is pressurized above a specific pressure threshold. As expandable member  210  is pressurized and expanded (as illustrated in  FIG. 2C ), infusible layer  221  can be compressed between expandable member  210  and a vessel wall  99 , causing transfer of the therapeutic agent to vessel wall  99 . 
     Pressure thresholds can be as low as about 0.5 psi to about 28 psi above ambient pressure of the lumen. (Ambient pressure can be the normal pressure within the lumen, or in other embodiments where compression is to be applied to the surrounding tissue before and/or during a procedure, ambient pressure can be the pressure within the lumen under compression.) For example, outer barrier  225  can comprise any film or membrane material that does not permit macroscopic transfer of the therapeutic agent in a vein below a pressure of about 15 psi, about 5 psi, or about 3 psi and does permit such transfer above the threshold pressure. In an embodiment, outer barrier  225  can comprise a fluoropolymer film, e.g., PTFE film. Other suitable film materials include polyurethane, polyester, PEBAX and other nylons, PVC, PVDF, polyethylene, and or other biocompatible polymer used in medical applications. 
     In other or the same embodiments, outer barrier  225  can be configured to transfer the therapeutic agent upon radial expansion, which alters the permeability of the microstructure of outer barrier  225 . In an embodiment, outer barrier  225  material can comprise a fibrillated structure, such as expanded fluoropolymers (e.g., ePTFE) or polyethylene, fibrous structures (such as woven or braided or non-woven mats of fibers, microfiber, nanofibers), or films with openings created during processing (such as laser or mechanically drilled holes or foams or microporous membranes, etc.). In another embodiment, the material comprises micropores between nodes interconnected by fibrils, such as in ePTFE. In another embodiment, the material comprises micropores in an essentially nodeless ePTFE, as described in U.S. Pat. No. 5,476,589 to Bacino, which is hereby incorporated by reference in its entirety. 
     Outer barrier  225 , on its outer surface, can be modified with textures, protrusions, depressions, grooves, coatings, particles, and the like. These can serve various purposes such as to modify tissues into which therapeutic agents will be (or have been) delivered, control placement of the system of the disclosure, and direct fluid transfer. In another embodiment, outer barrier  225  can contain or be marked with radiopaque markers or be constructed to be radiopaque in its entirety. To properly track and place vascular drug delivery device  200 , clinicians can use such radiopaque indicators. 
     To further control the delivery of a therapeutic agent, outer barrier  225  can comprise sections or areas that remain impermeable to the therapeutic agent throughout the treatment process. For example, having an impermeable end cap(s) can further mitigate undesired migration of the agent. Areas of outer barrier  225  can be made impermeable by coating or imbibing with polyurethane, silicone, or any other material that can render the outer barrier  225  impermeable where applied. 
     In some embodiments, with reference to  FIG. 2D , vascular drug delivery device  200  can comprise an inner expandable member  210  and an outer drug delivery component  220  which can extend and retract through the lumen of a vessel by eversion. Everting permits expandable member  210  and drug delivery component  220  to extend through and substantially occupy a lumen, even a tortuous lumen, e.g. a saphenous vein, along lengths up to and greater than 200 cm. Expandable member  210  and drug delivery component  220  together can form a layered tubular member, wherein expandable member  210  is a base layer and drug delivery component  220  is a surface layer that covers at least a section of the expandable member  210 . The proximal end of layered tubular member can be mounted on the distal end of elongate member  230 . In an extended configuration, drug delivery component  220  is located about the outer surface of expandable member  210  and both extend from the end of elongate member  230 . In the initial position, expandable member  210  and drug delivery component  220  can be folded or longitudinally compressed about elongate member  230  or retracted within lumen of elongate member  230  (as illustrated in  FIG. 2C ). Upon pressurization of expandable member  210 , expandable member  210  and drug delivery component  220  can evert and/or extend through the lumen of a vessel or the like. In some embodiments, with reference to  FIG. 2D , the distal end of layered tubular member can be sealed and can extend into lumen unguided. In other embodiments, with reference to  FIG. 2E , a distal end of the layered tubular member can be coupled to a distal end of second elongate member  235 , which is slideable with the lumen of elongate member  230 . This embodiment can facilitate extending along a path provided by a guidewire. 
     Once expandable member  210  and drug delivery component  220  are in the desired location, the position of the components can be fixed to prevent further extension. To facilitate fixation, device  200  can further comprise a length fixation mechanism, i.e., a mechanism to prevent further extension of device  200  once desired location is reached. For example, length fixation mechanism can comprise a tethering device  250 , such as a tube, guidewire, filament, thread, or the like coupled to the distal end of expandable member  210 . Tethering device  250  can slideably extend from the distal end of expandable member  210  to the proximal end of device  200 . In some embodiments, tethering device  250  can extend through inflation lumen. During a treatment procedure, once the device is located along the treatment area, the proximal end of tethering device  250  can be secured, and thereby, the length of expandable member  210  and drug delivery component  220  can be fixed. Other length fixation mechanisms can comprise a clamp, a fastener, or the like which secures a proximal section of expandable member  210  and/or drug delivery component  220  to elongate member  230 , thereby preventing further extension. 
     Once the therapeutic agent has been delivered to the surrounding tissue, expandable member  210  and drug delivery component  220  can be collapsed and then retracted. To facilitate retraction, tethering device  250  can be pulled and the expandable member  210  and drug delivery component  220  can evert into the lumen of expandable member  210  and eventually into the lumen of elongate member  230 . Optionally, tethering device  250  can be twisted and pulled during re-eversion to retract. Another mode of retraction can include simply pulling, or twisting and pulling, in the proximal direction on the proximal end of elongate member  230 . In an embodiment, retraction of expandable member  210  and drug delivery component  220  can be conducted in conjunction with extrinsic manipulation (e.g., manual compression) of the treated tissue. 
     In an alternative configuration, with reference to  FIG. 2F , vascular drug delivery device  200  can comprise inner expandable member  210  and outer drug delivery component  220  mounted on a distal portion of elongate member  230 . Elongate member  230  extends through the length of the lumen to be treated. Once in position, drug delivery component  220  can be infused and expandable member  210  can be pressurized. 
     In accordance with another embodiment, a method of delivery can comprise the steps inserting drug delivery device  200  into a vessel; advancing to a location proximate the treatment site; and evening expandable member  210  and drug delivery component  220  by increasing the pressure within expandable member  210 . Pressure can be increased by injecting an inflation medium into expandable member  210 . During eversion, the compliant layered tubular combination of drug delivery component  220  and expandable member  210  will advance along the path of least resistance, thereby avoiding any minor side branches. 
     Once drug delivery component  220  is extended along the desired treatment site, reduce the pressure within expandable member  210 ; e.g., reduce the pressure to a minimal or negligible pressure; and secure proximal end of tethering device  250 . Securing tethering device  250  will “lock” the length of device  200 , i.e., not allow further eversion during subsequent pressurizations. 
     A further step can comprise infusing a therapeutic agent into drug infusible layer  221 . During injection of the therapeutic agent, the agent can displace any air entrapped in drug infusible layer  221 ; this air can be expelled through ventilation lumen  223  and exit the ventilation port located on the hub. Once a drop of therapeutic agent exits the ventilation port, the clinician can be sure that drug infusible layer  221  is substantially infused or full. Upon observing a certain amount of the therapeutically agent exiting the ventilation port, the infusion and ventilation ports can be closed. 
     Another step can comprise increasing the pressure within expandable member  210 . Increasing pressure within expandable member  210  will apply pressure to drug infusible layer  221  and outer barrier  225 . When a pressure threshold is exceeded, outer barrier  225  will begin to allow trans-mural perfusion of the therapeutic agent. In this manner, the agent can be delivered directly to the surrounding tissue. 
     Additional steps can comprise slightly reducing the pressure within the expandable member  210  an amount to permit device  200  to evert into elongate member  230  and applying tension to tethering device  250 . Tension applied to tethering device  250  will force device  200  to evert back within itself, and ultimately, back within the elongate member  230 . As device is re-everted, i.e., retracted, the inflation medium within expandable member  210  will be slowly forced out of the unlocked expansion port. 
     A further step can require repeating the aforementioned steps because once expandable member  210  and drug deliver component  220  are completely retracted, elongate member  230  can be repositioned and the procedure can be repeated. Once the therapy is complete, elongate member  230  can be removed from the vasculature. 
     In the above described method of delivery, it is contemplated that compression to the surrounding tissue can be applied before, during, and/or after a treatment procedure. Compression, which reduces the volume of the lumen, can be applied across the length of the lumen. For example, in the case of a treatment procedure involving an arm or a leg, such as a saphenous vein treatment, compression socks or the like can be utilized. In addition, the tissue can be monitored with non-invasive imaging, e.g., ultrasound to assess the efficacy of the treatment. 
     In another aspect of the present disclosure, an occluding device comprises a bioabsorbable, lumen-occluding implant, which can optionally be imbibed with a therapeutic agent. Bioabsorbable, lumen-occluding implants (also referred to herein “bioabsorbable implants”) comprise an implant made of a bioabsorbable material that has an occlusive effect. In some embodiments, the bioabsorbable implant can expand to occupy a width or cross-section approximately the width of the lumen or body cavity to be occluded. In the same or different embodiments, based on the selection of the bioabsorbable material or the therapeutic agent, the bioabsorbable implant can cause a thrombogenic response to form an occlusion and/or a spasmodic response to form an occlusion by causing the surrounding tissue to shrink or collapse around the implant. To facilitate the occlusive effect, manual compression techniques about the surrounding tissue to collapse and/or reduce to volume of the lumen can be utilized. In some embodiments, bioabsorbable implants have lengths which extend along a length of a lumen and/or conform to the shape of the lumen. 
     Bioabsorbable, lumen-occluding implants can be useful for the treatment of saphenous vein incompetency, endoleaks, perivalvular leaks, patent ductus, patent foramen ovale, aortic dissection, growing aneurysms, gastro-esophageal reflux, and obesity (by shrinking the gastro-esophageal junction or pylorus), tumors, or any disease or condition where local drug delivery and/or an occlusive or spasmodic effect is desired. Some embodiments could be used as an alternative to tubal ligation or vasectomies, and embodiments causing a spasmodic response could also be useful in cosmetic wrinkle reduction applications. 
     Embodiments herein can be adapted for use in cell based therapy such as cell seeding. Embodiments can be imbibed with cells and further imbibed with nutrients and/or other therapeutic agents. 
     Further embodiments described herein include systems or kits comprising a bioabsorbable implant and a delivery device. In some embodiments, delivery devices comprise an implantation guide which facilitates delivery of the bioabsorbable implant or bioabsorbable implant component to an implantation site by providing a delivery path. In other embodiments, delivery devices comprise an implantation guide and a translating member, wherein the translating member facilitates translation of the bioabsorbable implant along the delivery path defined by the implantation guide. Translating member embodiments include a syringe, an implantation piston member, or any other device that facilitates translation of the bioabsorbable implant along the delivery path. 
     Bioabsorbable lumen-occluding implants describe herein can comprise any shape suitable for introduction into a lumen. For example, in occluding a lumen, bioabsorbable implant can comprise any space-filling member with a generally round or polygonal cross-section such as a spherical, ovoidal, cylindrical, ellipsoidal or prismoidal shape, or combinations and/or repetitions of the foregoing. Bioabsorbable implant can have a generally open framework or a hollow center, or alternatively, it can be generally solid. In addition, in some embodiment, bioabsorbable implants can comprise a generally elongated dimension, i.e., having a greater length than width or height. Bioabsorbable implants can be made to be permeable and/or can also be fashioned into bioabsorbable conduits through which a therapeutic agent can be infused. 
     In an embodiment, the bioabsorbable implant can be configured to conform approximately to the dimensions of the lumen to be occluded. In the same or different embodiments, the bioabsorbable implant can facilitate the surrounding tissue conforming to the dimensions of the bioabsorbable implant, such as through the use of therapeutic agents like spasmodic agents, pro-coagulants, and/or biocompatible glues/tissue adhesives, as well as manual compression. 
     Bioabsorbable, lumen-occluding implants describe herein can optionally be imbibed or infused with a therapeutic agent and/or comprise a modified outer surface to have an improved or additional bioactive response. In an embodiment, modifying the surface can comprise any modification that increases the surface area of the bioabsorbable implant. In some embodiments, surface modifications can enhance the thrombogenic response caused by bioabsorbable implant. One modification comprises adhering small fiber particles to at least a portion of the surface of bioabsorbable implant, creating an at least partially flocked surface. These small fiber particles can also be bioabsorbable. Another modification can comprise an abraded or roughened surface. 
     Bioabsorbable elements referred to herein, namely, bioabsorbable, lumen-occluding implants, anchoring mechanisms, radiopaque markers, occlusive material, and occlusive members, comprise bioabsorbable material(s). Bioabsorbable materials, as used herein, comprise any material capable of biological absorption. Such materials include copolymers of lactic acid and glycolic acid (PLA/PGA) adjusted in the desired ratio to achieve the desired rate of biological absorption. Other potentially useful bioabsorbable materials include polyglycolic acid (PGA), poly-L-lactic acid (PLA), polydiaoxanone (PDS), polyhydroxybutyrate, copolymers of hydroxybutyrate and hydroxyvalerate, copolymers of lactic acid and E-caprolactone, oxidized regenerated cellulose and various forms of collagen. A most preferred material is polyglycolide: trimethylene carbonate tri-block copolymer (PGA:TMC), e.g., the non-woven, bioabsorbable web material described in U.S. Pat. No. 7,659,219 by Biran et al. entitled “Highly porous self-cohered web materials having hemostatic properties,” which is hereby incorporated by reference in its entirety. This material has a history of use as bioabsorbable sutures; it is described in detail by U.S. Pat. No. 4,429,080 to Casey et al., which is hereby incorporated by reference in its entirety. The proportions of this or any other selected copolymer or blends of polymers can be adjusted to achieve the desired absorption rate. Other potentially useful bioabsorbable, non-autologous materials including porous forms are described by U.S. Pat. No. 4,243,775 to Rosencraft et al.; U.S. Pat. No. 4,300,565 to Rosencraft et al.; U.S. Pat. No. 5,080,665 Jarrett et al.; U.S. Pat. No. 5,502,092 Barrows et al.; U.S. Pat. No. 5,514,181 to Light et al. and U.S. Pat. No. 5,559,621 to Minato et al., and published PCT application WO 90/00060 to Chu et al., all of which are hereby incorporated by reference in their entireties. 
     Implantation guide, referred to herein, can comprise any tubular member or hollow needle having a lumen through which an occluding device can pass through to be implanted into a lumen. In some embodiments, the implantation guide can be sufficiently flexible to extend along or traverse a curved or tortuous section of vasculature. In other embodiments, implantation guide does not need to extend along a curved or tortuous section of vasculature and thus, flexibility is not required. 
     The bioabsorbable implant embodiments described herein can further comprise bioabsorbable radiopaque markers to facilitate monitoring of the bioabsorbable implant in situ with non-invasive imaging techniques (e.g., ultrasound imaging). For example, markers can be mounted on a proximal and/or distal end of the implant. In an embodiment, markers may be useful to ensure the device is properly positioned at a vessel junction. 
     In one embodiment, with reference to  FIG. 3A , an occluding device  300  comprises a bioabsorbable, lumen-occluding implant  360  having an anchoring mechanism  365  coupled thereto. Anchoring mechanism  365  is any device suitable for maintaining the position of the bioabsorbable implant  360  in situ. For example, when implanted into a blood vessel for purposes of creating a permanent occlusion, the flow of blood should not dislodge the bioabsorbable implant  360 . Anchoring mechanisms  365  can include a barb, a suture line  366 , stent, or the like. Anchoring mechanism  365  can be coupled to implant at a proximal or distal end of implant  360  or any other suitable location on implant  360 . 
     In one embodiment, occluding device  300  comprises a bioabsorbable, lumen-occluding implant  360  securely coupled to bioabsorbable suture line  366 . Suture line  366  can be any length sufficient to extend from implant  360  to a point where suture line  366  can be secured, such as through the insertion path to the skin surface. A first end of suture line  366  can be securely coupled to bioabsorbable implant  360  at a proximal or distal end of bioabsorbable implant  360  or any other suitable location on implant  360 . In an embodiment where suture line  366  exits the surface of the skin, suture line  366  can be knotted or, taped or cut flush with the surface of the skin. 
     In another embodiment, an occluding device  300  comprises a bioabsorbable, lumen-occluding implant  360  coupled to at least one bioabsorbable barb, hook, or stent (collectively referred to as “barb”). Barb can be any structural component that can penetrate a tissue making it difficult to become naturally dislodged from the implantation site. In an embodiment, barb can be self-setting such that as implant  360  is inserted or injected into position, the barb will radially extend away from implant  360  and into surrounding tissue. The barb can be coupled to implant  360  at a proximal or distal end of the implant or any other suitable location on implant  360 . In an embodiment, at least a portion of the barb can be oriented to generally curve, point or extend in the direction of blood flow to facilitate engagement with the surrounding tissue. 
     With reference to FIG. B and  FIGS. 3C-1 to 3C-5 , bioabsorbable implant  360  can be pre-loaded into a capsule  370 . The pre-loaded device capsule  370  can be designed to connect to a syringe  382  and an implantation guide  380 . With the use of the syringe  382 , capsule  370  and syringe  382  can be filled with a delivery fluid (such as saline or a therapeutic agent solution). With the use of implantation guide  380  (and optionally, an ultra sound device), access is gained to the implantation site, e.g., the lumen of a vessel. Once implantation guide  380  is in position, capsule  370  and syringe  382  are connected to implantation guide  380 . The plunger of the syringe  382  can then be depressed causing occluding device  300  to be implanted and anchored into position. 
     In various embodiments, pre-loaded device capsule  370  comprises a housing  371  defining at least one delivery chamber  372  in which at least one occluding device  300  as described above is oriented for delivery. Delivery chamber  372  is any pass-through cavity or compartment within housing  371  of appropriate dimensions for storing occluding device  300  in position for expulsion. As a pass-through, chamber  372  has an entrance end  376  and an exit end  375 . 
     In order to connect to implantation guide  380  and syringe  382 , housing  371  comprises connectors  373 ,  374 , such as a Luer taper fitting, about each end  375 ,  376 . For examine, housing  371  can comprise a male-taper fitting about exit end  375  for connecting to implantation guide  380 . About entrance end  376 , housing  371  can comprise a female taper fitting for connecting to syringe  382 . Device capsule  370  can further be hygienically sealed to maintain a sterilized delivery chamber  372  and occluding device  300 . The caps or seals can be fitted onto the connectors  373 ,  374  and can be removed or disrupted at the time of use. 
     In various embodiments, pre-loaded device capsule  370  can be configured to receive an imbibing fluid containing at least one therapeutic agent. In this manner, occluding device  300  contained therein can be imbibed with a therapeutic agent moments prior to implantation. In an embodiment, delivery capsule  370  can comprise a pressure imbibing port and be configured to withstand positive pressures. The delivery chamber  372  can be filled with an imbibing fluid, liquid and/or gas, and held under positive pressure. 
     In other embodiments, pre-loaded device capsule  370  can comprise a plurality of delivery chambers  372  configured to revolve, such as with the aid of a ratchet device. Each delivery chamber  372  is loaded with occluding device  300  as described above. Such embodiments can help streamline the process of implanting multiple occluding devices  300  in a single treatment procedure. For example, in occluding a length of a vessel, a plurality of device can be implanted to align end to end as illustrated in  FIG. 3C-5 . In a further embodiment, pre-loaded device capsule  370  can comprise a pressure imbibing port for purposes of simultaneously imbibing a plurality of occluding devices  300 . 
     In accordance with another embodiment, implant kit can comprise (i) implantation guide  380  having a lumen through which occluding device  300  as described above can pass through; (ii) pre-loaded device capsule  370  as described above, and (iii) at least one syringe which facilitates the expulsion of at least one occluding device  300  from chamber  372  through the lumen of implantation guide  380  out of distal tip. In an embodiment, a distal end of implantation guide  380  can comprise an angled-cut tip and/or have a generally arced profile to facilitate placement of occluding device  300 . Syringe  382  can be manually operated or be operated through automation. 
     In accordance with another embodiment, a method of delivery can comprise the following steps. In any particular order, a clinician can connect syringe  382  to pre-loaded device capsule  370  and insert implantation guide  380  into the lumen of a vessel ( FIG. 3C-1 ). Placement of implantation guide  380  can be guided with the use of an ultrasound device. Once implantation guide  380  is in position, pre-loaded device capsule  370  is fitted onto implantation guide  380  ( FIG. 3G-2 ). Bioabsorbable implant  360  can then be expulsed through implantation guide  380  via the depression of syringe  382  plunger ( FIG. 3C-3 ). Anchor mechanism  365  is then deployed ( FIG. 3C-1 ). 
     In an embodiment where anchor mechanism  365  comprises suture line  366 , suture line  366  remains within lumen of implantation guide  380 , so upon retraction of implantation guide  380 , suture line  366  extends along the insertion path to the surface of the skin. Suture line  366  can then be cut flush with skin, taped down, and/or knotted. 
     Implantation guide can be withdrawn and the aforementioned steps can be repeated at a neighboring location to implant a plurality of occluding devices  300  ( FIG. 3C-5 ). 
     In another embodiment, with reference to  FIGS. 4A-1 and 4A-2 , and  FIGS. 4B-1 TO 4B-2  an occluding device  400  comprises bioabsorbable, lumen-occluding implant  460  having a generally conformable conformation  461  when loaded into implantation guide  480  and a convoluted conformation  462  when released from implantation guide  480 . Convoluted conformation  462  can comprise coiled or spiral configuration, an undulating configuration, and/or a more random configuration of bends, twists, or whorls configuration. 
     In accordance with another aspect of the disclosure, with reference to  FIGS. 4A-1 to 4A-2  and  FIGS. 4B-1 to 4B-2 , an occluding device and delivery device system comprises implantation guide  480  circumscribing an extendable and retractable implantation piston member  496 : and bioabsorbable lumen-occluding implant  460  having a generally conformable conformation  461  when loaded into implantation guide  480  and a convoluted conformation  482  when released from guide  480 , wherein bioabsorbable lumen-occluding implant  460  can be releasably coupled to implantation piston member  496 . 
     Implantation piston member  496  can comprise an elongated component that passes through the lumen of implantation guide  480  and releasably couples to occluding device  400 . In an embodiment, implantation piston member  496  comprises an outer tube  497  with a translatable inner core  498  located within and along the lumen of outer tube  497 . Implantation piston member  496  has a recessed distal end by way of outer tube  497  extending beyond translatable inner core  498  a certain distance. Along this distance or a portion thereof, outer tube  497  is dimensioned to fit snugly over occluding device  400 . Outer tube  497  is also dimensioned to slideably extend and retract throw implantation guide  480 . In this manner, occluding device  400  can be loaded into implantation guide  480  and then it can be retracted and extended until occluding device  400  is released. 
     In order to release, translatable inner core  498  can be actuated to slide and extend within the lumen of outer tube  497  so that it is at least flush with the distal end of outer tube  497 . In this manner, occluding device  400  is forced out of the lumen of outer tube  497  and released from implantation piston member  496 . 
     In accordance with another embodiment, a method of loading occluding device  400  into implantation guide  480  comprises the steps of inserting a proximal end of occluding device  400  into a distal end of implantation piston member  496 ; retracting implantation piston member  496  and occluding device  400  into implantation guide  480  lumen. 
     In accordance with another embodiment, a method of delivery can comprise the following steps. First, implantation guide  480  is inserted into lumen. Once in position, implantation piston member  496  can be selectively extended so that occluding device  400  is released from implantation guide  480  and acquires a convoluted conformation  462 . If desired, occluding device  400  can be again retracted into the lumen of implantation guide  480  by retracting implantation piston member  496 . The steps at extending and retracting occluding device  400  can be repeated until occluding device  400  is in the desired implantation position. Once in the proper position, occluding device  400  can be released by actuating implantation piston member  496 . For example, actuating implantation piston member  496  can comprise sliding and extending translatable inner core  498  along the lumen of the outer tube  497 . 
     In an embodiment, with reference to  FIGS. 4C-1 to 4C-2 , occluding device and delivery system comprises a implantation guide  480 , an actuatable cutter mechanism  484 , and a bioabsorbable implant  460  having a conformable conformation  461  when loaded into guide  480  and a convoluted conformation  462  when released from guide  480 , wherein the bioabsorbable implant  460  can be selectively extended and retracted, and then selectively severed with cutter mechanism  484  after a sufficient length of bioabsorbable implant  360  is implanted. Similarly, in an embodiment, occluding device and delivery system comprise guide  480 , a cutter mechanism  484 , and a bioabsorbable implant  480  having a customizable length. 
     In order to sever bioabsorbable implant  460 , cutter mechanism  484  can comprise a blade  485  located on a distal end portion of implantation guide  380  and an actuating component extending from the blade  485 . Blade  485  can be oriented so that the cutting edge faces toward the center of implantation guide  480  lumen. Upon actuation, blade  485  moves across implantation guide  480  lumen and can optionally reset itself. Blade  485  can comprise any material of suitable hardness to cut bioabsorbable implant  460 . Blade  485  can be a hard polymer or a metallic component. Blade  485  can comprise a shape memory material, such as nitinol. 
     In an embodiment, with reference to  FIGS. 4C-1 to 4C-2 , an occluding device and delivery system comprise implantation guide  480 , an actuatable cutter mechanism  484 , and a bioabsorbable implant  460  having a conformable conformation  461  when loaded into guide  480  and a convoluted conformation  462  when released from guide  480 , wherein the bioabsorbable implant  460  can be selectively extended and retracted, and then selectively severed with cutter mechanism  484  after a sufficient length of bioabsorbable implant  360  is implanted. Similarly, in an embodiment, occluding device and delivery system comprise guide  480 , cutter mechanism  484 , and a bioabsorbable implant  460  having a customizable length. 
     In order to sever bioabsorbable implant  460 , cutter mechanism  484  can comprise a blade  485  located on a distal end portion of implantation guide  380  and an actuatable component extending from the blade  485 . Blade  485  can be oriented so that the cutting edge faces toward the center of implantation guide  480  lumen. Upon actuation, blade  485  moves across implantation guide  480  lumen, and can optionally reset itself. Blade  485  can comprise any material of suitable hardness to cut bioabsorbable implant  460 . Blade  485  can be a hard polymer or a metallic component. Blade  485  can comprise a shape memory material, such as nitinol. 
     In accordance with another embodiment, a method of delivery comprise the steps of extending and/or retracting occluding device  400  through lumen of implantation guide  480 ; selectively severing occluding device  400  by actuatable cutter mechanism  484 . 
     In an embodiment, with reference to  FIGS. 5A-1 to 5A-5 , occluding device  500  can comprise a two-component bioabsorbable, lumen-occluding implant  560  wherein a first component comprises an occlusive member  590  defining a lumen or a cavity and a second component comprises an occlusive material  592 . A further embodiment can also comprise a guidewire  594  and implantation guide  580  wherein occlusive member  590  is mounted around the distal end of guidewire  594 . Implantation guide  580  can be configured to slide over guidewire  594  into the lumen or cavity of occlusive member  510 , and after the retraction of guidewire  594 , guide  580  can inject occlusive material  592  therein. For example, occlusive member  590  can be a sleeve closed at a distal end and dimensioned, in its unexpanded state, to be situated around or circumscribe the distal end of implantation guide  580 . 
     In an embodiment, as occlusive material  592  is injected into the lumen, occlusive member  510  can distend or expand to occupy and approximately conform to the lumen of a vessel or other surrounding empty space. For example, occlusive member  590  can have a pleated or knitted conformation which can expand upon introduction of occlusive material  592 . In other embodiments, occlusive member  590  can comprise a flexible material which stretches and/or expends upon introduction of occlusive material  592 . 
     In other embodiments, occlusive member  590  can comprise an elongated, compliant, and convoluted conformation, which permits occlusive member  590  to be substantially straight when fitted or mounted around implantation guide  580  or guide wire  594 , but as it  590  is released from implantation guide  580 , it  590  takes on a convoluted conformation, which has a space-filling, occlusive effect. 
     In the same or different embodiments, occlusive member  590  is not distensible, but rather, bioabsorbable implant  500  facilitates the surrounding tissue conforming to the dimensions of the filled occlusive member ( 590  and  592 ), such as through the use of therapeutic agents like spasmodic agents, pro-coagulants, and/or biocompatible glues/tissue adhesives imbibed or infused into occlusive material  592 , as well as manual compression. 
     Similar to other bioabsorbable implants described herein, occlusive material  592  can be optionally imbibed with a therapeutic agent. Occlusive member  590  can comprise a sufficiently porous or permeable material to permit transfer of the therapeutic agent to its outer surface. 
     Occlusive material  592  can comprise any bioabsorbable material that is suitable for filling occlusive member  590 . In an embodiment, occlusive material  592  can be an injectable material, i.e., suitable for transporting through the lumen of implantation guide  580 . For example, occlusive material  592  can comprise flowable material like a liquid, small particle solid materials and/or materials having loft, which can include non-woven web materials, tufts of fibers, a plurality of small spherical particles, or an emulsion. In a preferred embodiment, occlusive material  592  can comprise the non-woven, bioabsorbable web material made with poly(glycolide), also known as PGA, and poly(trimethylene carbonate), also known as TMC, described in U.S. Pat. No. 7,659,219 by Biran et al., entitled “Highly porous sell-cohered web materials having hemostatic properties,” which is hereby incorporated by reference in its entirety. 
     Occlusive member  590  comprises a bioabsorbable material formed into any thin-walled structural component that defines a lumen or cavity and can be expanded to occupy and approximately conform to a lumen vessel or a body cavity. Occlusive member  590  can comprise a bioabsorbable film or fabric that does not permit passage of occlusive material  592 . Occlusive member  590  can comprise a distensible and compliant film or fabric to facilitate approximately conforming to the surrounding space. 
     Occlusive member  590  can be any shape suitable for occluding the desired lumen or body cavity. As mentioned above, occlusive member  590  can comprise an expandable sleeve. Expandable sleeve comprise a generally tubular shape having a proximal and a distal end and a lumen there through. The distal end can be permanently closed to contain occlusive material  592  as it is injected. Implantation guide  580  can be inserted through the proximal end to deliver occlusive material  592 . 
     In order to close the occlusive member  590  so that occlusive material  592  does not leak from occlusive member  590  once implantation guide  580  is withdrawn, occlusive member  590  can be self-sealing or comprise a closure in order to at least substantially close the proximal end upon withdrawal of guide  580 . Closure can comprise any mechanism or configuration that will close the proximal end of occlusive member  590 . For example, closure can comprise self-collapsing section of occlusive member  590 , such as an elastic band the will collapse down and close the proximal end of the occlusive member  590  upon retraction of implantation guide  580 . Other closure embodiments can include a purse string, cap, or the like. 
     In an embodiment, wherein occlusive material  592  is injected along with a therapeutic agent, the transfer of the therapeutic agent may need to be restricted to permeating through only certain portions of occlusive member  590 . According, occlusive member  590  can comprise sections or areas that remain impermeable to a therapeutic agent at least during the initial absorption phase. For example, having an impermeable end cap(s) on occlusive member  590  can mitigate undesired migration of a therapeutic agent. Areas of occlusive member  590  can be made impermeable by coating with bioabsorbable sealant such as copolymers of lactic acid and glycolic acid (PLA/PGA), or varying the microstructure or thickness in these areas to make less permeable. 
     In accordance with another embodiment, a method of delivering occluding device  500  can comprise the steps of extending occlusive member  590  on guidewire  594  into a vessel; passing implantation guide  580  over guidewire  594  and into lumen of occlusive member  590 ; and injecting occlusive material  592  into lumen of occlusive member  590 . Implantation guide  380  can be retracted as it injects occlusive material  592 . Once implantation guide  580  is completely retracted, occlusive member  590  can collapse around the opening of occlusive member  590  through which the implantation guide  580  entered. Collapsing can be facilitated by a closure. 
     While bioabsorbable implants are discussed in relation to providing an occlusive effect, implants can be modified to cause a thrombolytic effect and can be inserted into a tissue or vasculature where a thrombolytic response is desired. 
     It will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the spirit or scope of the disclosure. Thus, it is intended that the present disclosure cover the modifications and variations of this disclosure provided they come within the scope of the appended claims and their equivalents. 
     Likewise, numerous characteristics and advantages have been set forth in the preceding description, including various alternatives together with details of the structure and function of the devices and/or methods. The disclosure is intended as illustrative only and as such is not intended to be exhaustive. It will be evident to those skilled in the art that various modifications can be made, especially in matters of structure, materials, elements, components, shape, size and arrangement of parts including combinations within the principles of the disclosure, to the full extent indicated by the broad, general meaning of the terms in which the appended claims are expressed. To the extent that these various modifications do not depart from the spirit and scope of the appended claims, they are intended to be encompassed therein.