Bioabsorbable flow diverting scaffold

Abstract

To provide an endovascular device configured to divert blood flow from a pathology associated with a blood vessel.SOLUTION: There is provided an endovascular device, comprising a resiliently deformable tubular body for positioning in a body lumen defined by a body wall. The tubular body spans at the neck of the aneurysm in the body lumen and is configured to divert blood flow from the aneurysm. The tubular body comprises a braid of interwoven bioabsorbable polymeric fibers, and at least one deformable metal wire. Each bioabsorbable polymeric fiber has a diameter in the range of about 30 μm to about 80 μm. The at least one deformable metal wire (i) is configured to facilitate or maintain at least one expansion of the bioabsorbable polymeric fiber in the radial or axial direction in the tubular body and (ii) comprises a radio opaque material configured to facilitate imaging.SELECTED DRAWING: Figure 9B

Description

[Technical Field]

[0001] 1. Field of the Invention This disclosure relates to a braid of bioabsorbable polymer fibers for implantation within a body cavity of a mammalian organism. Certain aspects of the present disclosure relate to scaffolds made of a material that diverts blood flow away from vascular associated lesions. The present invention relates to such a braided scaffold configured as follows:

[0002] 2. Related Applications This application claims priority to U.S. patent application Ser. No. 62 / 641,891, which The entire contents of which are incorporated herein by reference. [Background technology]

[0003] 3. Description of Related Technology There are many medical devices known in the art that are implanted into blood vessels in the body to treat various pathologies. For example, aneurysms are caused by localized weak spots in the blood vessel wall. Aneurysms are balloon-like structures that bulge outward. Because aneurysms have thin, weak walls, they can burst. There is a risk. "Flow-diverting" scaffolds have been proposed to treat aneurysms, which A stent is inserted across the neck of the aneurysm, diverting the flow through the aneurysm and preventing arterial obstruction. Heal the aneurysm. In this way, the flow is diverted so that it does not have to enter the aneurysm. Such deflection scaffolds are described, for example, in U.S. Pat. No. 871,531 and U.S. Pat. No. 82,531. No. 67986. U.S. Pat. No. 871,531 and U.S. Pat. No. 8,267,986 describes a scaffold made of braided metal wires. The Flex Embolization Device (Medtronic) is designed to Used for the endovascular treatment of intracranial aneurysms with a neck. Pipeline® Fle The embolization device consists of a 75% cobalt chromium / 25% platinum tungsten wire. are. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent No. 871,531 [Patent Document 2] U.S. Patent No. 8,267,986 Summary of the Invention [Problem to be solved by the invention]

[0005] The metallic compositions of the deflection scaffolds known in the art present drawbacks. They are permanent and and cannot be removed, increasing the risk of thrombosis (which may lead to patients being prescribed antiplatelet medications) (requiring long-term administration of steroids), hyperplasia, prevention of vascular lumen remodeling or dilation Metal scaffolds also present various drawbacks, including the risk of vascular occlusion. The reflected signal tends to be too bright, which can affect the state of CT and MRI imaging after implantation. This presents a drawback in certain circumstances.

[0006] Therefore, it is possible to prevent or treat disease while minimizing negative effects on the body at the implant site. There is a need for implantable devices that eliminate or reduce the adverse response. They have advantages over metal scaffolds, including being non-permanent. However, clinical studies have shown that It has been shown that the risk of thrombosis is higher in absorbed coronary arteries (Masayuki et al.,Circulation 136,A15796-A15796;Raeber et al.,ACC(Journal Am. Coll. Cardiol. 6 6,1901-1914;Kang et al.,ACC Cardiovasc. Interv. 9,1203-1212). Furthermore, Waksman et al. (Circ. Ca rdiovasc. Interv. 10,e004762) is a bioabsorption study of PLLA. The results demonstrate the high thrombogenicity of scaffolds fabricated with the properties of hydrophilic polymers.

[0007] Further aspects and features of the present invention will become apparent from the following detailed description of specific embodiments of the invention taken in conjunction with the accompanying drawings. This will become apparent to those skilled in the art upon review of the description. [Means for solving the problem]

[0008] Aspects of the present disclosure include an elastically deformable tubular catheter for placement within a body cavity defined by a body wall. a device comprising a tubular body, the tubular body being made of interwoven bioabsorbable polymer fibers; The device includes a braid, and the tubular body includes at least 38 polymer fibers. In various embodiments, when the device is in the expanded configuration, the braid has a thickness of about 5% to In various embodiments, the device has a porosity in the range of about 80%. When in the configuration, the braid has a porosity ranging from about 60% to about 80%.

[0009] Aspects of the present disclosure include a resiliently deformable tubular catheter for placement within a body cavity defined by a body wall. a device comprising a tubular body, the tubular body being made of a braid of interwoven bioabsorbable polymer fibers; and when the device is in the expanded configuration, the braid has a thickness in the range of about 60% to about 80%. In various embodiments, the tubular body has a porosity of at least 3 Contains eight polymer fibers.

[0010] In various embodiments of the device, the braid comprises 38 to 96 strands of a bioabsorbable polymer. In various embodiments, the braid comprises at least 44 bioabsorbable polymer fibers. In various embodiments, the braid comprises at least 46 bioabsorbable polymer fibers. In various embodiments, the braid comprises at least 48 bioabsorbable polymer fibers. In various embodiments, the braid comprises at least 72 bioabsorbable polymer fibers. In various embodiments, the braid includes 44 bioabsorbable polymer fibers. In one embodiment, the braid comprises 46 bioabsorbable polymer fibers. The braid includes 48 bioabsorbable polymer fibers. In various embodiments, the braid includes 72 bioabsorbable polymer fibers. In various embodiments, the braid comprises at least 96 bioabsorbable polymer fibers. It comprises absorbent polymer fibers.

[0011] In various embodiments of the device, the bioabsorbable polymer fibers are at least about 30 In various embodiments, the bioabsorbable polymer fibers have a diameter of about 30 μm to about 40 μm. In various embodiments, the bioabsorbable polymer fibers have a diameter in the range of about 80 μm. In various embodiments, the bioabsorbable polymer fibers have a diameter of about 50 μm. In various embodiments, the bioabsorbable membrane has a diameter of about 60 μm. In various embodiments, the bioabsorbable polymer fibers have a diameter of about 70 μm. In one embodiment, the bioabsorbable polymer fibers have a diameter of about 80 μm.

[0012] In various embodiments of the device, the bioabsorbable polymer fibers are 2-under- In various embodiments, the bioabsorbable polymer is woven in a 2-over-2 pattern. The yarns are interwoven in a 1-over-2-under-2 pattern. In this embodiment, the bioabsorbable polymer fibers are woven in a 1-over-1-under-1 pattern. They are combined.

[0013] In various embodiments of the above device, the diameter of the tubular body is about 4 mm. In this configuration, the bioabsorbable polymer fibers are interwoven at a pitch angle of about 16° or less. In various embodiments, the bioabsorbable polymer fibers are interwoven at a pitch angle of about 14° or less. can be.

[0014] In various embodiments of the above device, the diameter of the tubular body is about 5 mm. In the configuration, the bioabsorbable polymer fibers are interwoven at a pitch angle of about 12° or less. In various embodiments, the bioabsorbable polymer fibers are woven at a pitch angle of about 10° or less. will be done.

[0015] In various embodiments of the above device, the diameter of the tubular body is about 3 mm. In some embodiments, the bioabsorbable polymer fibers are interwoven at a pitch angle of about 18° or less. In various embodiments, the bioabsorbable polymer fibers are woven at a pitch angle of about 16° or less. To be combined.

[0016] In various embodiments of the above device, the diameter of the tubular body is about 7 mm. In the method, the bioabsorbable polymer fibers are interwoven at a pitch angle of about 9° or less.

[0017] In various embodiments of the above device, when the device is in the expanded configuration, the braid Approximately 10 pores / mm 2 ~approximately 32 pores / mm 2 The pore density ranges from 0.01 to 0.01.

[0018] In various embodiments of the above device, the tubular body further comprises a visualization aid. In embodiments, the visualization aid comprises a radiopaque material. Radiopaque materials include iodine or barium. The device includes at least one wire comprising a radiopaque material, each wire having a plurality of It is interwoven with bioabsorbable polymer fibers to form part of the braid.

[0019] In various embodiments of the device, the tubular body is configured to extend radially and radially within the body cavity. and / or means for promoting and / or maintaining axial expansion. In an embodiment, the means for promoting and maintaining expansion of the tubular body within the body cavity comprises at least It is a single wire, and each wire is woven with multiple bioabsorbable polymer fibers to form a braid. In various embodiments, at least one wire is radiopaque. Contains sexual materials.

[0020] In various embodiments of the device, the at least one wire is elastically deformable. In various embodiments, the elastically deformable wire is a nickel- Titanium alloys or cobalt-chromium-nickel alloys. The wires are individually coated with a radiopaque material, nickel-titanium alloy, nickel- A drawn filled tube (DFT:dra) with an outer layer of titanium alloy and a core containing radiopaque material wn filled tube), an outer layer containing a radiopaque material and a nickel-titanium DFT with a core containing a nickel alloy, cobalt-chromium-coated with a radiopaque material Contains a nickel alloy, an outer layer of cobalt-chromium-nickel alloy, and a radiopaque material (DFT) with a core or outer layer containing a radiopaque material and cobalt-chromium The DFT includes a core comprising a nickel-nickel alloy.

[0021] In various embodiments of the above devices, the radiopaque material is iodine or barium. Includes:

[0022] In various embodiments of the device, the radiopaque material is a radiopaque metal. In various embodiments, the radiopaque metal includes tantalum, gold, platinum, or It's a combination of those.

[0023] In various embodiments of the device, at least one wire is a tantalum-coated nickel wire. Includes Tinol wire.

[0024] In various embodiments of the device, at least one wire is made of nitinol. It contains a DFT with an outer layer and a platinum core.

[0025] In various embodiments of the above-described devices, the at least one wire is a two-wire , 3 wires, 4 wires, 5 wires, 6 wires, 7 wires, 8 wires Includes ear, 9 wire, or 10 wire.

[0026] In various embodiments of the above device, the plurality of polymer fibers may comprise polylactide ( PLA), polyglycolide (PGA), polycaprolactone (PCL), polylactide co-glycolide (PLGA), polyanhydrides, polyorthoesters, poly(N-(2- Hydroxypropyl) methacrylamide), poly(l-aspartamide), DLPLA- Poly(dl-lactide), poly(L-lactic acid), LPLA-poly(l-lactide), PDO -Poly(dioxanone), PGA-TMC-poly(polyglycolide-co-trimethylene) carbonate), PGA-LPLA-poly(l-lactide-co-glycolide), PGA -DLPLA-poly(dl-lactide-co-glycolide), LPLA-DLPLA-poly Poly(l-lactide-co-dl-lactide), PDO-PGA-TMC-poly(glycolide) methylpropional-co-trimethylene carbonate-co-dioxanone), or any combination thereof In various embodiments, the plurality of polymer fibers includes polylactide. Polylactide (PLA), polylactide-co-glycolide (PLGA), DLPLA-poly(dl -lactide), poly-L-lactic acid), LPLA-poly(l-lactide), PGA-LPLA -Poly(l-lactide-co-glycolide), PGA-DLPLA-poly(dl-lactide) LPLA-DLPLA-poly(l-lactide-co-dl-lactide) In various embodiments, multiple The polymer fibers include poly-L-lactic acid (PLLA).

[0027] In various embodiments of the device, the tubular body is bonded to a bioabsorbable polymer fiber. In various embodiments, the bioabsorbable polymer fibers are coated with a therapeutic agent. In various embodiments, the therapeutic agent is an antibiotic, an antiviral, an analgesic, Muscle relaxants, chemotherapy drugs, intra-arterial vasodilators, calcium channel blockers, calcium channel blockers receptor antagonists, calcium channel blockers, transient receptor potential protein blockers, endothelial cell Phosphate antagonists, blood thinners, antiplatelet drugs, or any combination thereof. In embodiments, the therapeutic agent is aspirin, heparin, ticagrelor, 5-fluorouracil, or the like. In various embodiments, the therapeutic agent is cyclohexyl, melphalan, or clopidogrel. , paclitaxel, sirolimus, everolimus, temozolamide, cyclophosphamide, xorubicin, irinotecan, azathioprine, methotrexate, cisplatin, or is vincristine.

[0028] In various embodiments of the above device, the body cavity is the lumen of a blood vessel. In various embodiments, the blood vessel is an intracranial blood vessel. The catheter is positioned adjacent to the catheter to divert blood flow away from the lesion. The lesions may be aneurysms, cancer, infections, coronary artery disease, carotid atherosclerosis, or is intracranial atherosclerosis.

[0029] In various embodiments of the device, the device is used to treat a body wall lesion or a lesion in the body wall. and placed in a body cavity at a site adjacent to the lesion proximal to the This is for the purpose.

[0030] Aspects of the present disclosure include a catheter that is deployed within a body cavity to treat a lesion in a body wall defining the body cavity or a lesion in the body wall. The present disclosure relates to the use of the device as defined above for treating a lesion in the vicinity of a The present embodiment is a method for treating a lesion in a body wall defining the body cavity or in proximity to the body wall by deploying the device in the body cavity. The present disclosure relates to the use of the device as defined above for delivering a therapeutic agent to a lesion. In one embodiment, the device is deployed within a body cavity and positioned near a lesion in or proximal to a body wall defining the cavity. The present invention relates to the use of the device as defined above for delivering lactic acid to the site of a lesion. In embodiments, the body wall is a wall of a blood vessel. In various embodiments, the blood vessel is an intracranial blood vessel. In various embodiments, the lesion is an aneurysm, cancer, infection, coronary artery disease, carotid artery disease, or the like. atherosclerosis, or intracranial atherosclerosis.

[0031] Aspects of the present disclosure include a method of treating a lesion in or proximal to a body wall, comprising: The method includes injecting a sarcoma, as defined above, into a body cavity defined by the body wall at a location proximal to the lesion. Aspects of the present disclosure relate to methods for treating a body wall lesion or lesions thereof, including deploying a device. A method for delivering lactic acid to a site of a lesion proximal to a body wall, the method comprising: Deploying such a device within a body cavity defined by a body wall at a site In various embodiments, the body wall is a wall of a blood vessel. In various embodiments, the lesion is an aneurysm, cancer, infection, coronary artery disease, carotid atherosclerosis, or intracranial atherosclerosis. [Brief explanation of the drawings]

[0032] [Figure 1] FIG. 1 is an isometric view of an implantable device including a braid of interwoven bioabsorbable polymer fibers according to a first embodiment. [Figure 2]FIG. 2 is a photograph of an embodiment of an implantable intravascular device comprising 48 interwoven poly-L-lactic acid (PLLA) polymer fibers. [Figure 3] FIG. 3 is a photograph showing an embodiment of an implantable intravascular device comprising 48 interwoven poly-L-lactic acid (PLLA) polymer fibers demonstrating the elastic deformability of the device. [Figure 4] FIG. 4 is a schematic diagram of an implantable device comprising a braid of interwoven fibers showing the pitch angle. [Figure 5] FIG. 5 is a schematic diagram of a braiding machine useful for manufacturing devices of the present disclosure. [Figure 6A] FIG. 6A is an isometric view of an implantable device according to a second embodiment of the present invention, including a braid of interwoven bioabsorbable polymer fibers and a radiopaque material. [Figure 6B] FIG. 6B is a side view of the device shown in FIG. 6A. [Figure 7A] FIG. 7A is a photograph showing an embodiment of an implantable intravascular device comprising 44 interwoven poly-L-lactic acid (PLLA) polymer fibers and 4 radiopaque wires. [Figure 7B] FIG. 7B is an enlarged view of the device of FIG. 7A. [Figure 8A] FIG. 8A is a photograph of an embodiment of an implantable intravascular device comprising 46 interwoven poly-L-lactic acid (PLLA) polymer fibers and two radiopaque wires. [Figure 8B] FIG. 8B is an enlarged view of the device of FIG. 8A. [Figure 9A] FIG. 9A is a schematic illustration of a diversion application for treating an aneurysm. [Figure 9B] FIG. 9B is a schematic illustration of a diversion application for treating an aneurysm. [Figure 10] FIG. 10 is a schematic illustration of a diversion application in combination with an aneurysm bridging application. [Figure 11A]FIG. 11A is an early arterial phase angiogram taken before device implantation showing an aneurysm created in a rabbit carotid artery with a secondary aneurysm at the apex of the aneurysm. [Figure 11B] FIG. 11B is an early venous phase angiogram of the same aneurysm shown in FIG. 19A (same angiographic run as above) before device implantation, showing rapid contrast washout outside the daughter pouch. [Figure 11C] FIG. 11C is an early venous phase angiogram of the same aneurysm shown in FIGS. 19A and 19B after device deployment, showing contrast stagnation in the aneurysm body indicative of a spillover effect. [Figure 12A] FIG. 12A is an angiogram of a rabbit aorta immediately after implantation of a device containing 44 bioabsorbable PLA fibers and radiopaque tantalum-coated nitinol fibers. [Figure 12B] FIG. 12B is an angiogram of the rabbit aorta depicted in FIG. 14A one month after device implantation. [Figure 13] FIG. 13 is a scanning electron micrograph (SEM) showing sustained patency of rabbit aortic side branches one month after device implantation. [Figure 14] FIG. 14 is a gross histology image of a device containing 44 bioabsorbable PLA fibers and 4 radiopaque tantalum-coated nitinol fibers after implantation in a rabbit aorta. [Figure 15] FIG. 15 is a scanning electron micrograph (SEM) showing the formation of a smooth neointimal layer on the stent struts one month after the device was implanted in a rabbit aorta. [Figure 16A] FIG. 16A is a histological cross-section of a rabbit aorta showing the persistence of polymer fibers and neointima formation over the fibers one month after device implantation. [Figure 16B] FIG. 16B is a histological cross-section of a rabbit aorta showing persistence of the polymer fibers, neointima formation overlying the fibers, and the lack of a vigorous inflammatory response 2 months after device implantation. [Figure 17]FIG. 17 is a photograph of a device according to an embodiment disclosed herein consisting solely of bioabsorbable PLLA polymer fibers, demonstrating its ability to self-expand after being loaded into a 0.027 inch inner diameter catheter and then extruded. DETAILED DESCRIPTION OF THE INVENTION

[0033] <Definition> As used herein, a "pathology" refers to any part of a body tissue that constitutes or characterizes a disease, condition, or disorder. Refers to structural and functional deviations from normal.

[0034] As used herein, "including" means "including but not limited to."

[0035] As used herein, "consisting of" means "including and limited to" .

[0036] As used herein, a "drug" or "therapeutic agent" refers to a substance used to prevent or treat a disease. It refers to any of a variety of drugs, pharmaceutical compounds, and other bioactive agents that can be used as active agents. This can be done.

[0037] "Bioabsorbable," "biodegradable," and "bioresorbable" are used synonymously herein. Materials or structures used in biological tissues or systems that degrade or dissolve over time Refers to the construction.

[0038] As used herein, "body cavity" includes, but is not limited to, blood vessels, ureters, urethras, biliary Refers to cavities defined by tubular structures in the mammalian body, including ducts.

[0039] As used herein, "wall" refers to, but is not limited to, blood vessel walls, ureteral walls, and urethral walls. refers to tissues that form tubular structures in the mammalian body, including the walls of the bile ducts.

[0040] As used herein, a "scaffold" refers to a tubular structure that can be inserted into a body cavity. A scaffold includes: They can be inserted into blocked passages to keep them open and restore blood or other fluid flow. Scaffolds include stents, which have the primary purpose of keeping a blocked passageway open. This also includes devices that are intended to divert fluid flow rather than act as a barrier. The scaffold also acts as a support for tissue growth, such as intimal growth. The scaffolding can be made of either metal or plastic. It can be made of either of these.

[0041] As used herein, a "visualization aid" refers to any agent that facilitates fluoroscopic imaging. Refers to the structure.

[0042] As used herein, "elastically deformable" refers to a material that can be bent, stretched, compressed, or otherwise deformed. or other deformed object that can autonomously return to its original shape when released Regarding.

[0043] As used herein, an "endovascular device" refers to a prosthesis that can be implanted within a body cavity or duct. Point.

[0044] As used herein, "fiber" refers to the filaments, yarns, strands, or fibers from which fabrics are formed. Refers to the tendrils or strands.

[0045] As used herein, a "polymer fiber" refers to a series of repeating monolayers that are crosslinked or polymerized. In some embodiments disclosed herein, a single polymer unit is referred to as a fiber. In another embodiment, a combination of two or more polymers may be used. In another embodiment, the polymer can be used in conjunction with a radiopaque material. and polymer combinations can be used in various ratios to provide different properties. Polymers that can be used in the present invention include, for example, stable polymers, biostable polymers, Durable polymers, inert polymers, organic polymers, organic-inorganic copolymers or inorganic polymers Suitable polymers include those that are bioabsorbable, biocompatible, bioresorbable, resorbable, Degradable and biodegradable polymers.

[0046] As used herein, "divert" refers to the diversion of fluid flow away from the lesion site.

[0047] As used herein, "porosity" refers to the total surface area of ​​the device in its fully expanded configuration. The ratio of the free area to the total area, where the free area is the total area minus the surface area of ​​the material. In other words, the percentage of the total device wall surface area that is open and fiber-free. do.

[0048] This disclosure generally relates to implantable devices in either the prevention or treatment of pathologies, Any term or expression not expressly defined herein is not intended to be limiting. These definitions are generally accepted by those skilled in the art. To the extent that it relates to a specific embodiment or specific use, it is intended as an illustration only. The present invention is not limited to the above and is consistent with the detailed description and the appended claims. The broadest interpretation that is consistent should be given.

[0049] 1 and 2, a first embodiment of the present invention is shown. A device for placement relative to a body cavity for the purpose of providing a surgical instrument is generally indicated at 10. See FIG. As shown, the device 10 is formed from a braid 14 of interwoven bioabsorbable polymer fibers 16. 1, the tubular body 12 is made of a deformable material. When the chair 10 is deployed within a body cavity, it defines a lumen 18 that allows bodily fluids to continue to flow. The overlapping bioabsorbable polymer fibers 16 define pores 22.

[0050] In the presently described embodiment, the braid 14 comprises 48 bioabsorbable polymer fibers. However, the flow is blocked by only 38 bioabsorbable polymer fibers and at most This may be achieved by braiding 96 bioabsorbable polymer fibers. In various embodiments of the device, the braid may be 40, 42, 44, 46, 48, 50, 5 2, 54, 56, 58, 60, 62, 64, 66, 68, 70, 72, 74, 76, 78 , 80, 82, 84, 86, 88, 90, 92, or 94 bioabsorbable polymer fibers In certain embodiments of the presently disclosed devices useful for diversion, a braid are 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64 , 66, 68, 70, 72, 74, 76, 78, 80, 82, 84, 86, 88, 90, The tubular support may consist of 92, or 94 bioabsorbable polymer fibers.

[0051] For applications where leakage current is not necessary or desired, the braids in the disclosed invention may be Only 20 bioabsorbable polymer fibers, 18 bioabsorbable polymer fibers, and 16 bioabsorbable polymer fibers. Absorbable polymer fibers, 14 bioabsorbable polymer fibers, or 12 bioabsorbable polymer fibers The material may include mer fibers.

[0052] In the presently described embodiment, the braid 14 is a bioabsorbable braid having a diameter of 50 μm. The polymer fibers 16 are used to fabricate the devices useful for diversion disclosed herein. Bioabsorbable polymer fibers useful for this purpose have a diameter of at least about 30 μm, and generally about The diameters range from 30 μm to about 80 μm. In various embodiments of the device, the bioabsorbable polymer fibers are about 30 μm, about 40 μm, 50 μm, about 60 μm, about 70 μm, or about 80 μm in diameter. Those skilled in the art will appreciate that bioabsorbable polymer fibers having any diameter within this range may be used in a flow diversion device. It will be appreciated that this may be useful in the manufacture of

[0053] In the case of a flow diversion device, the tubular body is inserted through a microcatheter and in various applications. It must be highly flexible so that it can be delivered through tortuous blood vessels to the intracranial circulatory system. Therefore, the upper limit of the diameter of the bioabsorbable polymer fiber is determined by the desired flexibility of the tubular body. , as well as the diameter of the body cavity into which the device is deployed.

[0054] Figure 3 shows the feasibility of a device consisting of 48 poly-L-lactic acid (PLLA) bioabsorbable fibers. Photographs showing flexible and elastic deformability.

[0055] <porosity> The braided nature of the device is essential for diversion applications. The braid provides a sufficiently high material surface area. / allows the production of a tubular body with a sufficiently low porosity, so that the and preventing significant lateral flow of fluids through any part of the subject over which the device is spread. The braid also allows for the diversion of fluid flow away from the delivery site. This allows the device to be folded inside the microcatheter. The fibers slide relative to each other, thereby facilitating expansion and contraction of the tubular body.

[0056] For leakage applications, porosity is one of the most important design factors. Lower porosity reduces the risk of arterial resulting in lower inlet and outlet velocities of blood flow into the aneurysm sac, thereby reducing thrombus formation and increases the chance of early occlusion. Reducing the porosity of BW stents reduces the risk of aneurysms and parenteral Wall shear stress (WSS) is also reduced in both the arterial wall and the dome of the aneurysmal sac. The pressure within the scaffold increases as the porosity decreases, thereby creating a leaky scaffold currently in clinical trials. There is an increased risk of aneurysm rupture associated with

[0057] In leakage applications, the porosity of the tubular body is preferably in the range of about 60% to about 80%. In a preferred embodiment, the porosity ranges from about 60% to about 70%. In various embodiments of the device, the porosity is about 60%, about 65%, about 70%, about 75%, about 80%, about 85 ... 5%, or about 80%. In various embodiments, 10 pores / mm 2 ~approximately 32 pores / m m 2 In certain embodiments, a pore density of about 18 pores / m is desirable. m 2 Those skilled in the art will appreciate that as the porosity of the tubular body decreases, the flexibility / deformability of the tubular body decreases. Therefore, the limit to which the porosity can be reduced is It can also be determined by the flexibility required for the tubular body.

[0058] <Pitch angle> The pitch angle of the braiding process determines the material surface area and multi-layer structure of the tubular body in its expanded form. It is an important factor that affects porosity and therefore the flow escape capability of the device. The angle also influences the resilience of the device to deformation and therefore its self-expanding properties. Referring to FIG. 4, the elastically deformable tubular body of a device according to an embodiment of the present disclosure is generally The tubular body 212 is shown at 212. The tubular body 212 comprises a plurality of bioabsorbable polymer fibers 216. The overlapping bioabsorbable polymer fibers 216 define pores 218. is depicted on the mandrel 230 as the braid is produced. The pitch angle of the braid 250 is the angle formed between the bioabsorbable polymer fiber 216 and the transverse axis 260 of the tubular body 212 is.

[0059] Referring to FIG. 5, the pitch angle 260 of the braid effectively causes the bioabsorbable fibers 280 to adhere to the carrier 2. 40 to the mandrel 250. The angle is determined by the angle formed between the horizontal axis 270 and the zero point.

[0060] The pitch angle, the diameter element of the tubular body, and the diameter element of the bioabsorbable polymer fiber together This affects the porosity of the tubular body and the ability of the device to deflect flow. These variables are used to achieve a porosity in the range of a typical flow escape device. The diameter of the bioabsorbable polymer fiber or tubular body to be used must be adjusted accordingly. For a bioabsorbable polymer fiber with a diameter of 50 µm and a desired tubular body diameter of 4 mm, , the pitch angle should be about 16° or less, or about 15° or less. For a conical body diameter, the pitch angle should be about 12° or less, or about 11° or less.

[0061] For a desired tubular diameter of 3 mm, the pitch angle should be about 18° or less, or about 17° or less. If the desired tubular diameter is 7 mm, the pitch angle should be approximately 9° or less. Table 1 below shows the appropriate combinations of tubular body diameter, fiber diameter, and pitch angle. However, those skilled in the art will be able to understand the combinations shown here. The above is not intended to be limiting, and each element may be adjusted accordingly to achieve the appropriate porosity. It will be appreciated that this is well within the capabilities of those skilled in the art.

[0062] [Table 1]

[0063] The achievable pitch angle also depends on the quality of the polymer fiber, since the pitch angle is determined by the fiber This is because the smaller the pitch angle, the more tension there is in the fibers, which can cause damage to the fibers. The more small diameter fibers are added, the less porous the material becomes and the greater the surface area of ​​the material. , it is possible to achieve a lower pitch angle and therefore a lower porosity for the device. It should be possible.

[0064] <Bioabsorbable polymer fiber> The polymer fibers used in the manufacture of the disclosed devices are made of bioabsorbable polymeric materials. This polymeric material is capable of acting in vivo at a controlled / predictable rate and The degradation rate is determined by the polymer material, bioabsorbable polymer fiber, It may depend on the diameter, physiological conditions, porosity of the tubular body, etc.

[0065] Referring back to FIG. 2, the bioabsorbable polymer fibers 16 in the illustrated embodiment are made of poly-L -lactic acid (PLLA). However, polylactide (PLA), polyglycolide ( PGA), polycaprolactone (PCL), polylactide-co-glycolide (PLGA ), polyanhydrides, polyorthoesters, poly(N-(2-hydroxypropyl)methacrylate Poly(l-lactide), poly(l-aspartamide), DLPLA-poly(dl-lactide), poly Poly(L-lactic acid), LPLA-poly(l-lactide), PDO-poly(dioxanone), P GA-TMC - Poly(polyglycolide-co-trimethylene carbonate), PGA-L PLA-poly(l-lactide-co-glycolide), PGA-DLPLA-poly(dl- Lactide-co-glycolide), LPLA-DLPLA-poly(l-lactide-co-d l-lactide), PDO-PGA-TMC-poly(glycolide-co-trimethylene ether), bioabsorbents containing benzoxanone, benzoxanone-co-dioxanone, or any combination thereof One or more absorbent polymer fibers could be utilized.

[0066] In some applications, the proximal portion of the deployed device is exposed to promote scar tissue formation. In some cases, it may be desirable to induce an inflammatory response in the vicinity of the underlying tissue. For example, In the therapeutic application of stenosis, scar tissue in the blood vessel wall at the neck of the aneurysm heals. This promotes blood flow to the blood vessels, improving their strength and reducing the risk of aneurysm recurrence. In such applications, bioabsorbable polymer fibers that degrade to form lactic acid are used. It may be useful to use embodiments in which acidic degradation products accumulate, causing the pH of the surrounding tissue to drop. This may cause an inflammatory reaction or a foreign body reaction at the lesion site. Implantation of PLLA scaffolds into the vein increased the expression of inflammatory markers, which mediate the expression of numerous inflammatory cytokines. Thus, certain embodiments of the present invention involve the use of polylamellar Polylactide (PLA), polylactide-co-glycolide (PLGA), DLPLA-poly( dl-lactide), poly(L-lactic acid), LPLA-poly(l-lactide), PGA-LP LA-poly(l-lactide-co-glycolide), PGA-DLPLA-poly(dl-lactide-co-glycolide) Poly(l-lactide-co-glycolide), LPLA-DLPLA-poly(l-lactide-co-dl -lactide), or any combination thereof. obtain.

[0067] The devices disclosed herein, when axially expanded / expanded or compressed, It exhibits a special structural feature: upon expansion, this structure changes the initially tilted fibers to align with the stress direction. , and can therefore substantially accommodate strain or stress. Additionally, the individual polymer fibers slide against each other, providing elasticity and flexibility to the device. It is possible.

[0068] <Visualization aid> This braided assembly exhibits special structural characteristics when axially stretched or compressed. The initially tilted fibers are free to rotate to a position parallel to the stress direction, When stretched, the structure can substantially accommodate strain or stress. The polymer fibers can slide past each other, providing elastic and flexible properties to the device.

[0069] A physician deploying a device within a body cavity can determine the location of the device within that body cavity. Therefore, the devices disclosed herein may include a visualization aid. Accordingly, various embodiments of the implantable devices disclosed herein may: Radiopaque materials to facilitate imaging of intraluminal devices by fluoroscopy This will include the fee.

[0070] Such radiopaque materials include tantalum, platinum, tungsten, gold, iodine, or The radiopaque material may be a bioabsorbable polymer fiber. The selection can depend on the polymer material, imaging technique, lesion to be treated, etc.

[0071] Radiopaque materials can be combined in various ways, e.g., radiopaque materials and bioabsorbable polymers. - covalent bonding to the fibers, adhesion of radiation absorbing materials to bioabsorbable polymer fibers, or other attached to or in contact with, bonded to, blended with, or incorporated into the polymer fibers in the form of can be brought into contact.

[0072] Referring to Figures 6A, 6B, 7A, 7B, 8A, and 8B, the present invention provides a method for detecting a tumor with a visualization aid. 1. A device for placement relative to a body cavity to achieve diversion of body fluids according to a second embodiment of the present invention. The device is generally designated 310. The device 310 comprises an interwoven bioabsorbable The device includes an elastically deformable tubular body 312 formed from a braid 314 of elastic polymer fibers 316. Referring to FIG. 1, the tubular body 312 is configured to extend from the distal end of the device 310 when the device 310 is deployed in vivo. , defining a lumen 318 through which bodily fluids can continue to flow. The visualization aid comprises four radiopaque The wires 317 are interwoven with the bioabsorbable polymer fibers 316. The overlapping bioabsorbable polymer fibers 316 and The radiopaque wire 317 defines a pore 322 .

[0073] The embodiment shown in FIG. 7 has 44 bioabsorbable polymer fibers and 4 radiopaque fibers. The embodiment shown in Figure 8A utilizes 46 bioabsorbable polymer fibers. and two radiopaque wires. However, how many radiopaque wires are used? can also be used as a visualization aid. The number used will depend on various factors, including the nature of the radiopaque material. This may depend on various factors. At a minimum, one radiopaque wire may be sufficient. However, the ability to visualize the device is limited by the radiopaque wires used. In various embodiments, 2, 3, 4, 5, 6, 7, 8 9, 10, or 12 radiopaque wires may be utilized. Alternatively, an even number of radiopaque wires may be utilized to maintain balance. In this case, six radiopaque wires or eight radiopaque wires are utilized. The manufacturer has warned that the resolution of the device may decrease with increasing number of radiopaque wires. Therefore, the number selected determines the balance between image detectability and clarity. will understand that the

[0074] As mentioned above, the radiopaque wire 317 may be made of tantalum, platinum, tungsten, gold, The material may include a radiopaque material such as iodine, or a combination thereof. In embodiments, the radiopaque wire may be elastically deformable. In an embodiment, the elastically deformable wire is made of a nickel-titanium alloy (e.g., Nitinol ), cobalt-chromium alloys (e.g., Phynox), or cobalt-chromium-nickel Each elastically deformable wire is independently coated with a radiopaque material. Covered nickel-titanium alloy, nickel-titanium alloy outer layer and radiopaque material a drawn filled tube (DFT) having a core comprising a nickel-containing outer layer and an outer layer comprising a radiopaque material; - DFT with a core containing titanium alloy, cobalt coated with radiopaque material Chromium-nickel alloy, cobalt-chromium-nickel alloy outer layer and radiopaque material DFT with a core containing a radiopaque material, or an outer layer containing a radiopaque material and a cobalt- The core may be fabricated from DFT with a chromium-nickel alloy. In this example, the radiopaque wire is a tantalum coated nitinol wire. In one embodiment, the radiopaque wire has a Nitinol outer layer and a platinum core. This includes the DFT.

[0075] <Promoting and maintaining expansion> In particular, in devices for intravascular diversion applications, upon deployment within a body cavity, the presently disclosed It is important that the outer tubular surface of the device remain in intimate contact with the body wall. If the outer surface of the tubular body is not in close contact with the blood vessel wall, a blood clot may form in the space between the tubular body and the blood vessel wall. The device includes only the bioabsorbable polymer fibers disclosed herein. Although the embodiments are elastically deformable, they may contract or partially collapse within the vessel. Furthermore, bioabsorbable polymer fibers tend to degrade when stored in a compressed state for extended periods. They may tend to lose some of their ability to expand themselves.

[0076] Thus, various embodiments of the devices disclosed herein may be configured to include a tubular catheter that is intimately attached to the body wall. Promoting and / or maintaining radial expansion of the tubular body within the body cavity so as to maintain the outer surface of the body. Such means also facilitate axial expansion of the device and / or thus facilitating radial and / or axial expansion. and / or maintaining the device's ability to self-expand upon deployment within the lumen. obtain.

[0077] Promoting and / or maintaining radial and / or axial expansion of the tubular body within a body cavity The means for retaining the wire is interwoven with a plurality of bioabsorbable polymer fibers to form part of the braid. During operation, the wires exert a radial force on the tubular structure, causing the The tubular structure is then compressed against the body wall to facilitate radial expansion of the tubular structure in a fully expanded form. In certain embodiments, the wire is elastically deformable. The elastically deformable wire is made of nickel-titanium alloy or cobalt-chromium-nickel alloy. It may contain gold.

[0078] To facilitate and maintain radial and / or axial expansion of the tubular body, at a minimum, a simple A single wire may be sufficient, provided that the radial force exerted by the tubular body as it expands is increases with the number of wires used. In various embodiments, two, three, , 4, 5, 6, 7, 8, 9, 10, or 12 radiopaque wires Preferably, an even number of radiopaque wires can be used to balance the In a preferred embodiment, six radiopaque wires or eight radiopaque wires are used. A transparent wire is utilized.

[0079] The same wire serves as a visual aid and to facilitate radial and / or axial expansion. It will be readily apparent to those skilled in the art that the invention may be used both as a means to establish and / or maintain the integrity of the device. Therefore, the wire may be made of tantalum, platinum, tungsten, gold, iodide, or the like. The material may include radiopaque materials such as silicon dioxide, silicon dioxide particles ... In embodiments, the radiopaque wire can be elastically deformable. In an embodiment, the elastically deformable wire is made of a nickel-titanium alloy (e.g., NiTi). Cobalt-chromium alloys (e.g., Phynox), or cobalt-chromium-nickel Each elastically deformable wire is made of a Kell alloy. Each elastically deformable wire is independently made of a radiopaque material. Coated nickel-titanium alloy, nickel-titanium alloy outer layer and radiopaque material a drawn filled tube (DFT) having a core containing a material, an outer layer containing a radiopaque material, and a nickel Kel-DFT with a core containing titanium alloy, cobalt coated with radiopaque material -Chromium-nickel alloy, cobalt-chromium-nickel alloy outer layer and radiopacity DFT with a core containing a material, or an outer layer containing a radiopaque material and cobalt- It may be manufactured from DFT with a core comprising a chromium-nickel alloy. In this example, the radiopaque wire is a tantalum-coated nitinol wire. In an embodiment, the radiopaque wire has a Nitinol outer layer and a platinum core. This includes the DFT.

[0080] Therefore, metal wire components offer at least three independent advantages: 1) X-ray 1) radiopacity, thus enabling visualization by fluoroscopy; and 2) self-expanding. and 3) radial force (crushing force and By improving the chronic outward force, the outer wall of the tube can be kept in close contact with the body wall. and can provide.

[0081] <Manufacturing> Referring again to FIGS. 4 and 5, the devices disclosed herein may include, for example, individual Interwoven bioabsorbable polymer fibers, and (in various embodiments) radiopaque wire. The yarns can be formed into a braid that forms a tubular body.

[0082] For example, a device for deployment within a body cavity can be fabricated by braiding a tubular body using a "Maypole" machine. This avoids the need for known laser cutting techniques to manufacture the vise. Bioabsorbable polymer fibers of various diameters were braided on a mandrel at various pitch angles. This allows for the creation of braided hollow tubular bodies with varying porosity. The braid is oriented along the longitudinal axis of the structure. FIBER ASSEMBLIES WITH SET OF BIOABSORBABLE FIBER INTERMEDIATED IN A BIASED MANNER - Patent application The braid may be a clockwise or counterclockwise interlaced or spiral arrangement of fibers. That's fine.

[0083] Several patterns of braided or intertwined fibers can be used. The present invention is based on the following examples: That is, "1-over-1-under-1" or "half load" pattern, "2 -Under-2-Over-2" or "Diamond" pattern, "1-Under- 2-Over-2" (also known as "1-Over-2-Under-2"), if The present invention is not limited to either a "full load" pattern or other variations.

[0084] For a 1-under-2-over-2 pattern, use a 48 carrier machine. You can create a 1-over-1-under-1 pattern with 48 The design, which also includes two fibers, requires a 96-carrier machine. The desired pattern is: The width of the tubular body, the diameter of the bioabsorbable polymer fibers, and the number of fibers containing the particular bioabsorbable polymer. This can depend on several factors. For example, 2-under-2-over-2 means thicker braid. This affects the selection of possible tubular bodies that can be made with this pattern.

[0085] Referring to FIG. 5, as described above, the pitch angle of the braid is determined by the distance from the carrier 250 to the mandrel. 270, the bioabsorbable polymer fiber 280 (or wire 290) and the the transverse axis 275 of the mandrel 270 (i.e., the axis perpendicular to the longitudinal direction of the mandrel 270) is the angle formed between

[0086] With further reference to FIG. 5, in embodiments including optionally radiopaque wires, the braid The wires 290 are arranged in pairs on opposing carriers 240 so that forces are balanced within the assembly. It is preferable that the sensor be loaded as follows.

[0087] Elastically deformable radiopaque requiring heat treatment to set the original shape of the wire With respect to the embodiments disclosed herein that include wires, in some embodiments, the wires Setting the shape is not necessary or desirable, except to set the original shape of the wire. If you need to straighten the shape, try not to "anneal" it. It is important to note that this is due to the downstream radial force exerted by the tubular body during expansion. This can adversely affect the ability of the tubular body to properly expand after deformation or delivery through the catheter. Therefore, the wire cannot be shaped on the mandrel. However, it is preferable to form the wire on a mandrel using bioabsorbable polymer fibers. It is not desirable to heat the wire to 500 degrees Celsius in order to set the shape of the wire. The wire must be heated to a temperature of 300°C or higher, and the bioabsorbable polymer fiber is then inserted into the If it is on the dorel, it will melt. One option is to use polymer fibers. The first step is to shape the wire on the mandrel without any additional work. The yarn can be rewound onto a bobbin and braided with bioabsorbable polymer fibers. The advantage is that the final braid design is set at a lower temperature, which allows for Any residual stresses on the polymer fibers (e.g.) are relieved. This allows the final design to The shape of the bioabsorbable polymer fiber is essentially set, whereas the radiopaque wire is set. Another option is to use wires or bioabsorbable wire fibers, as mentioned above. The solution is to simply abandon the shape setting.

[0088] Some metal wires may flare at the ends of the scaffold during manufacturing and may cause damage during delivery. There is a possibility of perforation of the body wall (blood vessels, etc.). Flaring of the metal wires may occur if the scaffold is mandrel. It also depends on where the wire is cut from the scaffolding, for example, at the point where two metal wires meet. If the cut is accurate, it will be less likely to flare. , it may be preferable to solder metal wires together.

[0089] <Delivery of therapeutic drugs> The devices disclosed herein also can be used to treat lesions in or near a body wall defining a body cavity. The bioabsorbable polymer fibers of the tubular body may also be useful for delivering therapeutic agents to the target tissue. The therapeutic agent may be coated or bonded to the therapeutic agent, or the therapeutic agent may be The therapeutic agent may be incorporated into bioabsorbable polymer fibers. In the context of intravascular devices for implantation in blood vessels, ,Medical treatments include antibiotics, antivirals, analgesics, muscle relaxants, chemotherapy drugs, and intra-arterial vasodilators. Drugs, calcium channel inhibitors, calcium channel antagonists, calcium channel blockers , transient receptor potential protein blockers, endothelin antagonists, blood thinners, antiplatelet agents , or any combination thereof.

[0090] In various embodiments, the therapeutic agent is paclitaxel, sirolimus, everolimus, tetanus, or the like. Mozolamide, cyclophosphamide, doxorubicin, irinotecan, azathioprine, It may contain thiazolinone, cisplatin, or vincristine. In certain circumstances, the therapeutic agent may be an aspirin. Phosphate, heparin, ticagrelor, 5-fluorouracil, melphalan, or clopid It may contain one or more anticoagulants / antiplatelets such as grel.

[0091] The therapeutic agents may also be used in the form of their pharmaceutically acceptable salts or derivatives, and in the form of chiral active compounds. In the case of the active component, both the optically active isomers and the racemates, or the diastereomeric It is also possible to use stereoisomeric mixtures. Similarly, the therapeutic agent may be a compound or Prodrugs, hydrates, esters, derivatives or analogs of the molecule may be included.

[0092] As mentioned above, the polymer material itself may in some circumstances give rise to lactic acid upon degradation. This may help heal and strengthen the body wall at the site of lesions such as aneurysms. There is.

[0093] The therapeutic agent can be eluted over a controlled period of time, which minimizes side effects. The devices disclosed herein have been shown to be effective for treating ulcerative colitis. In this way, the therapeutic agent can be targeted to the disease site. On the other hand, the therapeutic agent may not be distributed to organs that do not contain the disease, so oral administration of the therapeutic agent This minimizes side effects such as those seen in the case of intravenous or intravenous administration.

[0094] At least two mechanisms can control the release kinetics of therapeutic agents: 1) concentration A diffusion-controlled mechanism in which the therapeutic agent diffuses out through the bulk polymer due to the gradient. and 2) release of the therapeutic agent is due to hydrolysis or other degradation of the polymeric material and the polymer fibers. This is a degradation control mechanism that relies on surface erosion.

[0095] The devices of the present disclosure are designed so that the early release of the therapeutic agent corresponds to the delayed clinical symptoms of the disease. The desired timing of release of the therapeutic agent can be varied. For example, it may be immediate for a patient who already has the disease. The device can be used prophylactically in patients at high risk of developing a disease or condition; In this case, the desired timing of drug release may be delayed.

[0096] The devices of the present disclosure may also regulate the release of the therapeutic agent in response to the introduction of another therapeutic agent, physiological conditions, or or may be configured to be triggered by any change within the body cavity.

[0097] <Operation> The disclosed device, which includes an elastically deformable tubular body, self-expands when deployed within a body cavity. The degree of expansion can vary depending on the polymer material, the crystallinity of the polymer, and the diameter of the polymer fiber. , the diameter of the tubular body, the pitch angle of the weave, the physiological conditions, the annealing temperature of the polymer, or It relies on the structural contribution of the included materials, such as radiopaque materials or similar components. Various embodiments of the devices disclosed herein are capable of self-expanding memory in vivo. can be shown.

[0098] The elastically deformable and self-expanding tube in the device disclosed herein The characteristic of the shaped bodies is that they are configured in a radially compressed state for implantation in an intracatheter. When properly deployed adjacent to a lesion within a body cavity, the device The tubular body expands radially and axially so that the outer surface of the tubular body is in close contact with the body wall defining the body cavity. The radial expansion of the device is achieved by the inflation of a balloon attached to the catheter. This can be assisted by Zhang.

[0099] The devices disclosed herein may be configured to facilitate delivery or rapid deployment. For example, the kit may be pre-loaded with a sheath or microcatheter. The device may be a delivery system suitable for inserting a device as disclosed herein into a patient. and delivering the device through a body cavity, e.g., the patient's vascular system, and into the patient's body. and deploying the device at a desired location for implantation. The delivery system may include a sheath, catheter, guidewire, and / or vascular device insertion system. , any other elements for delivery, guidance, deployment, and implantation, or a combination thereof. It may include.

[0100] According to one embodiment of the present disclosure, an intravascular device is provided for detecting an intravascular region or disease downstream of the blood flow. In particular, the device may be configured to prevent or divert unruptured or ruptured cerebral aneurysms. It may be necessary to divert blood through the vascular network to treat the vascular system. 9B, an intravascular device 910 is inserted into a vessel wall 91 proximal to an aneurysm 916. 8, and when the tubular body 914 is fully expanded, The outer surface is capable of adhering to the vessel wall 918 and expanding to span the neck 919 of the aneurysm. Therefore, a low braid porosity may divert blood flow past the neck of the aneurysm 916. At the same time, the braid is sufficiently thick to allow a small amount of blood to enter the aneurysm sac at a slow rate. Porous, which allows for thrombosis and occlusion of the aneurysm, allowing for healing of the aneurysm Referring to FIG. 9B, the braid is sufficiently porous to allow sufficient blood to pass through the pores to promote healthy circulation. The device is configured to connect the branches of the blood vessel, e.g., bifurcations 920, to the branches. It can span or partially span, thereby maintaining the patency of these branches.

[0101] In another embodiment, an intravascular device according to an embodiment disclosed herein may be used to: Supports coils deployed within an aneurysm and provides access to the parent vessel, e.g., by bridging the aneurysm The intravascular device is combined with a metal coil or balloon. 10, the aneurysm neck 101 may be configured to fit into the body cavity. In such a situation, the intravascular device 1010 may be 9 and supports a metal coil 1030 positioned within the aneurysm 1016. The intravascular device may, for example, This can prevent the metal coil from moving within the body cavity 1012 where the coil is inserted, for example, by preventing the coil from becoming engorged with blood. After the procedure, the intravascular device 1010 is typically In another embodiment, the intravascular The device may be configured to fit into a body cavity and support the metal coil in any manner. . [Example]

[0102] <Example> Although specific embodiments of the present invention have been described and illustrated, such embodiments are not intended to be limiting of the scope of the present invention. They are illustrative only and should not be considered as limiting the invention which is to be construed according to the appended claims. It should not be.

[0103] Example 1 Referring to Figure 4, the molecular weight of poly-L-lactic acid was 30,000 g / mol and the diameter was 50 μm. The device was made of 48 bioabsorbable polymer fibers.

[0104] Example 2 Referring to Figure 7, the bioabsorbable poly-L-lactic acid with a molecular weight of 30,000 g / mol and a diameter of 50 μm Consists of 44 absorbent polymer fibers and 4 radiopaque fibers of tantalum-coated nitinol The device was then placed in an animal's blood vessel, namely the large intestine of a rabbit. When tested in arteries, it did not occlude any blood vessels, keeping important side branches open. I was able to keep it that way.

[0105] 11A and 11B show the arterial and venous phases of the blood vessels during the early arterial and venous phases before implantation of the device. Figure 11B shows a time-lapse angiogram of an aneurysm. Washout indicates fluid flow into the aneurysm. In contrast, Figure 11C shows the device. This shows the early venous phase after implantation of the device, where the signal is retained in the aneurysm. that fluid is no longer flowing freely into the aneurysm and that the device has successfully redirected the flow away from the aneurysm. This shows that the target is being deflected.

[0106] Referring to Figures 12A and 12B, the aorta of the rabbit in which the device was placed was The patient demonstrated sustained angiographic patency of the aorta in which the device was placed, and was still considered a "jailbroken" aorta after one month. Figure 13 shows the side branch after implantation of the device. Scanning electron micrographs of rabbit aorta after 1 month showing persistent patency of side branches. .

[0107] Referring to Figure 14, the device demonstrated excellent vessel wall apposition.

[0108] Figure 15 shows a smooth neointima formed on the inner surface of the tubular body one month after implantation of the device. 1 is a scanning electron micrograph showing the layers.

[0109] FIG. 16A shows a histological cross section of a rabbit aorta, showing the polymer ion transporter 1 month after implantation of the device. -Shows persistence of fibers and neointima formation over the fibers.

[0110] FIG. 16B shows a histological cross section of a rabbit aorta 2 months after implantation of the device. The study demonstrated the persistence of polymer fibers, the formation of neointima overlying the fibers, and the absence of an active inflammatory response. are.

[0111] The lack of an active inflammatory response on histology at 2 months is indicative of the efficacy of bioabsorbable polymer fibers. This is believed to be due to the small diameter (approximately 50 microns). , and the previously FDA-approved laser-cut bioabsorbable stent (Abbott Vasc In contrast to the thick struts of the AbsorbBVS stent (marketed by ular) It is illustrative.

[0112] Formation of neointima lining the inner surface of this organ, as shown by histology at 2 months The lack of an active inflammatory response demonstrates the biocompatibility of the device with the vessel wall. Blood reactions to the material may result in undesired thrombosis or hemolysis. The thrombogenicity of the device is important in terms of thrombogenic response compared to the leading metallic flow escape device. The thrombogenicity of the device of the present disclosure was compared with that of a device called Pipeline (registered trademark). As shown in Tables 2 and 3, the blood The plug surface coverage % was low, indicating a low hemolytic index.

[0113] Table 2 shows the low thrombogenic surface coverage of the devices of the present disclosure compared to Pipeline®. The % coverage (tests performed according to ISO standards) is shown.

[0114] [Table 2]

[0115] Table 3 provides the results of in vitro hemolysis tests (performed according to ASTM standards) and shows the The device disclosed herein exhibits a lower hemolytic index compared to Prine®. .

[0116] [Table 3]

[0117] Without wishing to be bound by theory, the small diameter (approximately 50 μm) of the bioabsorbable polymer fibers This is believed to contribute to the observed biocompatibility. The relatively thick polymer fiber (Abso) with a fiber diameter of approximately 150 μm was confirmed. (marketed by Abbott Vascular as rbBVS) (Expert Opinion Drug Deliv. 2016 Oct;13(10):1489-99).

[0118] Example 3 Referring to FIG. 8A, the biosynthesis of poly-L-lactic acid with a molecular weight of 30,000 g / mol and a diameter of 50 μm was performed. 46 absorbable polymer fibers were inserted into two radiopaque tantalum-coated nitinol The device was then woven with fibers and tested in animal blood vessels. However, it was possible to keep important side branches open without occluding the vessel.

[0119] Although specific embodiments of the present invention have been described and illustrated, such embodiments are not intended to be limiting of the scope of the present invention. They are illustrative only and should not be considered as limiting the invention, which is to be construed in accordance with the appended claims. It should not be.

Claims

1. A device having an elastically deformable tubular body for placement within a body cavity defined by a body wall. the tubular body comprises a braid of interwoven bioabsorbable polymer fibers, The device, wherein the body comprises at least 38 polymer fibers.

2. When the device is in the expanded configuration, the braid has a porosity ranging from about 5% to about 80%. The device of claim 1 having a power of 1000 W / m.

3. When the device is in the expanded configuration, the braid has a multiplicity in the range of about 60% to about 80%. The device of claim 1 having a porosity.

4. A device having an elastically deformable tubular body for placement within a body cavity defined by a body wall. the tubular body comprises a braid of interwoven bioabsorbable polymer fibers, When the chair is in the expanded configuration, the braid has a porosity ranging from about 60% to about 80%. device.

5. The device of claim 4 , wherein the tubular body comprises at least 38 polymer fibers.

6. 6. Any one of claims 1 to 5, wherein the braid comprises 38 to 96 bioabsorbable polymer fibers. Item 1. A device as described in item 1.

7. 6. The method of claim 1, wherein the braid comprises at least 44 bioabsorbable polymer fibers.

10. The device according to claim 1.

8. 6. The method of claim 1, wherein the braid comprises at least 46 bioabsorbable polymer fibers.

10. The device according to claim 1.

9. 6. The method of claim 1, wherein the braid comprises at least 48 bioabsorbable polymer fibers.

10. The device according to claim 1.

10. 6. The method of claim 1, wherein the braid comprises at least 72 bioabsorbable polymer fibers.

10. The device according to claim 1.

11. 6. The method according to claim 1, wherein the braid comprises 44 bioabsorbable polymer fibers. Devices listed.

12. 6. The method according to claim 1, wherein the braid comprises 46 bioabsorbable polymer fibers. Devices listed.

13. 6. The method according to claim 1, wherein the braid comprises 48 bioabsorbable polymer fibers. Devices listed.

14. 6. The method according to claim 1, wherein the braid comprises 72 bioabsorbable polymer fibers. Devices listed.

15. 6. The method of claim 1, wherein the braid comprises at least 96 bioabsorbable polymer fibers.

10. The device according to claim 1.

16. Claims 1-15, wherein the bioabsorbable polymer fibers have a diameter of at least about 30 μm.

10. The device according to claim 1, wherein

17. The bioabsorbable polymer fibers have a diameter ranging from about 30 μm to about 80 μm.

16. A device according to any one of claims 1 to 15.

18. 16. Any of claims 1 to 15, wherein the bioabsorbable polymer fibers have a diameter of about 40 μm.

2. The device according to claim 1.

19. 16. Any of claims 1 to 15, wherein the bioabsorbable polymer fibers have a diameter of about 50 μm.

2. The device according to claim 1.

20. The bioabsorbable material according to any one of claims 1 to 15, having a diameter of about 60 μm. device.

21. 16. Any of claims 1 to 15, wherein the bioabsorbable polymer fibers have a diameter of about 70 μm.

2. The device according to claim 1.

22. 16. Any of claims 1 to 15, wherein the bioabsorbable polymer fibers have a diameter of about 80 μm.

2. The device according to claim 1.

23. The bioabsorbable polymer fibers are woven in a 2-under-2-over-2 pattern. The device according to any one of claims 1 to 22,

24. The bioabsorbable polymer fibers are woven in a 1-over-2-under-2 pattern. The device according to any one of claims 1 to 22,

25. The bioabsorbable polymer fibers are woven in a 1-over-1-under-1 pattern. The device according to any one of claims 1 to 22,

26. The device of any one of claims 1 to 25, wherein the diameter of the tubular body is about 4 mm. 。

27. 10. The method of claim 9, wherein the bioabsorbable polymer fibers are interwoven at a pitch angle of about 16° or less.

27. The device described in 26.

28. 10. The method of claim 9, wherein the bioabsorbable polymer fibers are interwoven at a pitch angle of about 14° or less.

27. The device described in 26.

29. The device of any one of claims 1 to 25, wherein the diameter of the tubular body is about 5 mm. 。

30. 10. The method of claim 9, wherein the bioabsorbable polymer fibers are interwoven at a pitch angle of about 12° or less.

29. The device described in 29.

31. 30. The method of claim 29, wherein the bioabsorbable polymer fibers are interwoven at a pitch angle of about 10° or less. The device described in

32. The device of any one of claims 1 to 25, wherein the diameter of the tubular body is about 3 mm. 。

33. 10. The method of claim 9, wherein the bioabsorbable polymer fibers are interwoven at a pitch angle of about 18° or less.

33. The device described in 32.

34. 10. The method of claim 9, wherein the bioabsorbable polymer fibers are interwoven at a pitch angle of about 16° or less.

33. The device described in 32.

35. The device of any one of claims 1 to 25, wherein the diameter of the tubular body is about 7 mm. 。

36. 3. The bioabsorbable polymer fibers are interwoven at a pitch angle of about 9° or less.

5. The device described in 5.

37. When the device is in the expanded configuration, the braid has about 10 holes / mm ２ ~Approximately 32 holes / mm ２ 37. The device of any one of claims 1 to 36, having a pore density in the range of

38. The device of any one of claims 1 to 37, wherein the tubular body further comprises a visualization aid. vinegar.

39. 39. The device of claim 38, wherein the visualization aid comprises a radiopaque material.

40. 40. The device of claim 39, wherein the radiopaque material comprises iodine or barium. 。

41. The visualization aid includes at least one wire comprising a radiopaque material, and each wire is interwoven with a plurality of said bioabsorbable polymer fibers to form part of said braid, 39. The device of claim 38.

42. The tubular body is configured to expand radially and / or axially within the body cavity.

41. The method according to claim 1, further comprising means for promoting and / or maintaining the device.

43. means for promoting and maintaining expansion of said tubular body within said body cavity; each wire interwoven with a plurality of bioabsorbable polymer fibers to form the braid; 42. The device of claim 41, forming part of

44. 44. The device of claim 43, wherein the at least one wire comprises a radiopaque material. vinegar.

45. 41, 43, or 44, wherein the at least one wire is an elastically deformable wire.

44. The device according to claim 44.

46. The elastically deformable wire is made of a nickel-titanium alloy or a cobalt-chromium-nickel alloy.

46. ​​The device of claim 45, comprising an alloy.

47. Each wire is independent, a nickel-titanium alloy coated with said radiopaque material; A stretch-filled catheter having an outer layer of nickel-titanium alloy and a core containing the radiopaque material. Filling tube (DFT), D having an outer layer including the radiopaque material and a core including a nickel-titanium alloy. FT, a cobalt-chromium-nickel alloy coated with said radiopaque material; an outer layer comprising a cobalt-chromium-nickel alloy; and a core comprising said radiopaque material. (DFT) with, or an outer layer comprising the radiopaque material; and a core comprising a cobalt-chromium-nickel alloy.

47. The method of claim 41, 43, 44, 45, and 46, comprising a DFT comprising: Devices listed.

48. Claims 41 and 43-47, wherein the radiopaque material comprises iodine or barium.

10. The device according to claim 1, wherein

49. The radiopaque material of claims 41 and 43 to 48 includes a radiopaque metal.

10. The device according to any one of claims 1 to 9.

50. The radiopaque metal is tantalum, gold, platinum, or a combination thereof.

50. The device of claim 49.

51. 41. The method of claim 41, wherein the at least one wire comprises a tantalum-coated nitinol wire. and a device according to any one of claims 43 to 50.

52. The at least one wire is a DF wire having a Nitinol outer layer and a platinum core.

52. The device of any one of claims 41 and 43 to 51, comprising T.

53. The at least one wire may be two wires, three wires, four wires, five wires, wire, 6 wire, 7 wire, 8 wire, 9 wire, or 10 wire 53. The device of any one of claims 41 and 43-52, comprising an ear.

54. The polymer fibers may be polylactide (PLA), polyglycolide (PGA), polycarbonate (PC), or Prolactone (PCL), polylactide-co-glycolide (PLGA), polyanhydride , polyorthoester, poly(N-(2-hydroxypropyl)methacrylamide), poly DLPLA-poly(dl-lactide), poly(L-lactic acid), LPLA - poly(l-lactide), PDO - poly(dioxanone), PGA - TMC - poly Poly(glycolide-co-trimethylene carbonate), PGA-LPLA-poly(l -lactide-co-glycolide), PGA-DLPLA-poly(dl-lactide-co- glycolide), LPLA-DLPLA-poly(l-lactide-co-dl-lactide), PDO-PGA-TMC-poly(glycolide-co-trimethylene carbonate-co- dioxanone), or any combination thereof. Item 1. A device as described in item 1.

55. The polymer fibers may be made of polylactide (PLA), polylactide-co-glycolide ( PLGA), DLPLA - poly(dl-lactide), poly-L-lactic acid), LPLA - poly (l-lactide), PGA-LPLA-poly(l-lactide-co-glycolide), PG A-DLPLA-poly(dl-lactide-co-glycolide), LPLA-DLPLA- poly(l-lactide-co-dl-lactide), or any combination thereof 54. A device according to any one of claims 1 to 53.

56. 54. Any of claims 1 to 53, wherein the plurality of polymer fibers comprises poly-L-lactic acid (PLLA).

2. The device according to claim 1.

57. Claims 1-5, wherein the tubular body includes a therapeutic agent bonded to the bioabsorbable polymer fiber.

7. A device according to any one of claims 6 to 6.

58. 57. The method of claim 1, wherein the bioabsorbable polymer fiber is coated with a therapeutic agent.

10. The device according to any one of claims 1 to 9.

59. The therapeutic agent may be an antibiotic, an antiviral agent, an analgesic, a muscle relaxant, a chemotherapy agent, an intra-arterial blood Vasodilators, calcium channel blockers, calcium channel antagonists, calcium channel Blockers, transient receptor potential protein blockers, endothelin antagonists, blood thinners, antihypertensives 55. The device of claim 53 or 54, which is a platelet-based drug, or any combination thereof. 。

60. The therapeutic agent may be aspirin, heparin, ticagrelor, 5-fluorouracil, melphalan, 55. The device of claim 53 or 54, which is tetracycline, tetracycline, or clopidogrel.

61. The therapeutic agent may be paclitaxel, sirolimus, everolimus, temozolamide, cyclophosphamide, or cyclophosphamide. Famide, doxorubicin, irinotecan, azathioprine, methotrexate, cisplatin 54. The device of claim 53, wherein the anticoagulant is vincristine or vincristine.

62. The device of any one of claims 1 to 61, wherein the body cavity is the lumen of a blood vessel.

63. 63. The device of claim 62, wherein the blood vessel is an intracranial blood vessel.

64. 62. A device according to claim 61, for placement adjacent to a lesion in the blood vessel to divert blood flow away from the lesion. Or the device described in 62.

65. The lesion may be an aneurysm, cancer, infection, coronary artery disease, carotid atherosclerosis, or 65. The device of claim 64, wherein the is intracranial atherosclerosis.

66. Within the body cavity, at a site adjacent to the body wall lesion or a lesion proximal to the body wall 57. A device as described in claim 55 or 56 for deployment to supply lactic acid to the site.

67. 67. The device of claim 66, wherein the lactic acid induces a biological response at the site of the lesion. Chair.

68. 68. The device of claim 67, wherein the response is healing of the aneurysm.

69. Use of the device of any one of claims 1 to 61, when deployed in a body cavity, Use for treating a lesion in or proximal to a body wall defining said body cavity. 。

70. The device is deployed in a body cavity to treat a lesion in the body wall defining the body cavity or a lesion proximal to the body wall.

62. Use of a device according to any one of claims 57 to 61 for delivering a therapeutic agent.

71. The device is deployed in a body cavity to treat a lesion in the body wall defining the body cavity or a lesion proximal to the body wall.

62. A device according to any one of claims 1 to 61 for delivering lactate to a site proximal to the Use of chairs.

72. 72. The use of claim 69, 70, or 71, wherein the body wall is a wall of a blood vessel.

73. 73. The use of claim 72, wherein the blood vessel is an intracranial blood vessel.

74. The lesion may be an aneurysm, cancer, infection, coronary artery disease, carotid atherosclerosis, or The use according to any one of claims 69 to 73, wherein the disease is intracranial atherosclerosis. 。

75. A method for treating a lesion in or near a body wall, comprising the steps of: a device defined in any one of claims 1 to 4, wherein the device is inserted into the body wall at a location proximal to the lesion. and deploying the device in a body cavity defined by the

76. Methods for delivering lactic acid to a site proximal to a body wall lesion or a lesion proximal to the body wall A device as defined in any one of claims 1 to 61 is placed in proximity to the lesion. deploying the device within a body cavity defined by the body wall at the site.

77. 77. The method of claim 75 or 76, wherein the body wall is a wall of a blood vessel.

78. 78. The method of claim 77, wherein the blood vessel is an intracranial blood vessel.

79. The lesions may be aneurysms, cancers, infections, coronary artery disease, carotid atherosclerosis, or The method according to any one of claims 75 to 77, wherein the disease is intracranial atherosclerosis or intracranial atherosclerosis. Law.

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