JP2006055634A - Device for filtering blood inside vessel with helical element and method therefor - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a filter and a method for filtering blood inside a blood vessel effective for capturing a blood clot and preventing pulmonary embolism. <P>SOLUTION: The filter 50 for capturing an embolus in a blood vessel in a patient's body has at least one helix 55 made of mesh material. The at least one helix has a plurality of turns 65 disposed spirally around an axis in the longitudinal direction. The mesh material has a plurality of pores 53 whose size is at least 120 μm (≥120 μm). The at least one helix also has a plurality of panels, which can move from the crushed state to the expanded state when disposed inside the blood vessel. In one embodiment, the mesh material is made of a self-expanding material, such as a nickel titanium alloy. In another embodiment, the filter has a double helix structure. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  In the human cardiovascular and circulatory system, the consistency of blood remains fluid enough for blood cells and other molecules to move smoothly through arteries and veins. However, in some cases, clots occur during a process called clotting. When blood clots or other blood-clots of tissue move through the circulatory system, they are called emboli, and single moving blood clots are called emboli or embolisms.

  Pulmonary embolism is a condition in which blood clots move through the venous system and eventually remain in the pulmonary artery that carries blood from the heart to the lungs. This can interfere with the supply of blood to the lungs, which is potentially fatal and should be treated as an emergency.

  Many pulmonary emboli result from a condition called deep vein thrombosis (DVT). DVT is the formation of blood clots in muscles, usually the lower limbs and possibly veins deeply buried in the pelvis or groin.

  A small net, vena cava filter, helps to prevent emboli from moving through the heart and into the lungs. Most commonly, the vena cava filter is inserted into the inferior vena cava, a thick vein that carries blood from the lower limbs.

  The vena cava filter is a normally metallic, umbrella-shaped device that captures the clot to prevent it from moving to the lungs and causing pulmonary embolism. Vena cava filters are typically used when drug therapy, such as treatment with a blood diluent, appears to be unsuccessful or inappropriate, or when drug therapy causes other dangerous medical conditions.

  This procedure is safe and effectively reduces the risk of pulmonary embolism in most people when performed by physicians skilled in filter insertion and when supplemented with medication.

  People who are likely to accept a vena cava filter are those who are at risk for pulmonary embolism or who are considered unsuitable for drugs or other therapies. A vena cava filter is also inserted to protect a wounded patient from pulmonary embolism associated with the wound.

  The procedure of placing the vena cava filter in the patient's body typically requires the physician to administer local anesthesia at the insertion site, ie, the arm, neck or groin, and make an incision. Patients can also receive muscle relaxants to improve comfort. Alternatively, the procedure may be performed while the patient is under general anesthesia.

  The physician then inserts the crushed filter through the catheter (long thin thin flexible tube) into the incision and advances the filter to the vena cava. The physician then deploys the filter at the target site in the vein, removes the insertion instrument, and closes the incision. This procedure typically takes 10-40 minutes. Antibiotics are prescribed as needed to minimize the risk of infection.

  The patient may stay in the hospital until the supervisor's doctor confirms that the filter is properly secured in the vena cava and that there are no complications due to the procedure. Even if a vena cava filter is present in the body, this does not adversely affect the use of daily or other medications. Some patients may remain on anticoagulant therapy to reduce the risk of clot formation after insertion or the risk of expanding an already existing clot.

  However, even though known vena cava filters are about 98% successful in preventing symptomatic pulmonary embolism, there are known complications that may occur during placement of the vena cava filter. These known filter devices and their placement techniques may be associated with complications from surgery and anesthesia, such as bleeding at the insertion site, anesthesia-related complications such as allergic reactions or breathing The above problems include stroke, pulmonary embolism and blood clots. Furthermore, as is well known in the art, these complications can be fatal as well as severe for the patient's health.

  Inferior vena cava (IVC) filter thrombosis after filter placement is often reported, and such thrombosis can occur in any type of filter currently used in the art. The onset of thrombosis can be delayed from hours to months after placement of the filter, but appears to be often in the first three months. Continued anticoagulant therapy has not been shown to prevent IVC thrombosis.

  Research has also shown that unfavorable hydrodynamic phenomena, such as increased pressure gradients, have occurred in filters with high clot capture capabilities. Accordingly, it is desirable to provide an instrument with high clot capture efficiency while minimizing the risk of increased pressure gradient.

  Accordingly, there is a need for devices and methods that can further reduce these serious and fatal complications in a reliable and predictable manner. To date, there are known filter devices designed to be able to eliminate these complications consistently, especially those that can cause pulmonary embolism and blood clots. Not.

  The present invention is a novel filter device and method for filtering blood in blood vessels that is very effective for clot capture and embolism prevention as compared to known prior art devices and methods.

  The present invention provides fluid or blood in blood vessels or organs that is highly effective in capturing blood clots, emboli, particulates and particles, and preventing embolism compared to known prior art devices and methods. A novel filter device and method for filtering. This device also avoids obstruction or restriction (squeezing) of blood flow.

  The present invention relates to various embodiments of devices and methods for capturing or collecting emboli in a blood vessel or organ of a patient's body.

  In one embodiment, the present invention is an instrument for capturing emboli in a blood vessel in a patient's body, having at least one helix made of mesh material, the at least one helix about a longitudinal axis The device is characterized in that it has a plurality of turns arranged in a spiral shape, a mesh material is provided with a plurality of pores, and the size of the pores is 120 μm or more.

  In another embodiment, the present invention is an instrument for capturing emboli in a blood vessel having a plurality of mesh panels that can move from a collapsed state to an expanded state when placed in a blood vessel, When in the expanded state, it forms a plurality of turns arranged spirally around the longitudinal axis, the mesh panel is provided with a plurality of pores, and the size of the pores is 120 μm or more It is a featured instrument.

  In another embodiment, the present invention is an instrument for capturing emboli in a blood vessel having a plurality of mesh panels that can move from a collapsed state to an expanded state when placed in a blood vessel, When in the expanded state, it forms a double helix structure to form a plurality of turns arranged in a spiral around the longitudinal axis, the mesh panel is provided with a plurality of pores, and the pore size is , 120 μm or more.

  Another embodiment of the invention is a method of capturing an embolus in a blood vessel in a patient's body, having at least one helix made of mesh material, the at least one helix about a longitudinal axis Providing a device having a plurality of turns arranged in a spiral, the mesh material having a plurality of pores, the pore size being ≧ 120 μm, and the device in a blood vessel in a patient's body The method of arranging in a.

  The method of the present invention further comprises placing the device in a blood vessel in the patient's body by moving the device from a collapsed state to an expanded state when the device is placed in the blood vessel. As another step, for example, there is a step of fixing the instrument to the inner wall of the blood vessel using a plurality of barbs.

  Another embodiment of the present invention is a method for capturing an embolus in a blood vessel of a patient's body, having at least one helix made of mesh material, the at least one helix about a longitudinal axis The mesh material has a plurality of turns arranged in a spiral, the mesh material is provided with a plurality of pores, the pore size is 120 μm or more, and the pore size is large at one end of at least one spiral body Providing a device varying in size from a size to a small size at the other end of the at least one helix, and placing the device in a blood vessel in the patient's body.

  Another method of the present invention is a method of capturing emboli in a blood vessel in a patient's body, having a plurality of mesh panels that can move from a collapsed state to an expanded state when placed in the blood vessel, When the mesh panel is in an expanded state, the mesh panel forms a plurality of turns spirally arranged around the longitudinal axis, the mesh panel is provided with a plurality of pores, and the pore size is 120 μm or more A method comprising providing an instrument and placing the instrument in a blood vessel in a patient's body.

  The method includes placing the instrument into a blood vessel in a patient's body by moving the instrument mesh panel from a collapsed state to an expanded state when the instrument mesh panel is placed in the blood vessel, and one or more securing mechanisms, eg, And fixing the device to the inner wall of the blood vessel by using a thorn.

  Another method of the present invention is a method of capturing emboli in a blood vessel in a patient's body, having a plurality of mesh panels that can move from a collapsed state to an expanded state when placed in the blood vessel, When the mesh panel is in an expanded state, the mesh panel forms a double spiral structure to form a plurality of turns arranged in a spiral around the longitudinal axis, and the mesh panel is provided with a plurality of pores. A method comprising providing an instrument having a size of 120 μm or more and placing the instrument in a blood vessel in a patient's body.

  In all embodiments of the invention, the pore size may be varied. For example, all the pore sizes may be 120 μm or more. Further, in all embodiments of the invention, the pore size of the instrument may vary from one end of the instrument to the other end of the instrument. For example, the pore size may vary from a large size pore at one end of the instrument to a small size pore at the other end of the instrument, with the pore size decreasing over the entire length of the instrument, i.e., fine. The size of the holes decreases from one end of the instrument to the other, which can be found, for example, in depth type filter instruments. At least one helix having a plurality of turns arranged in a spiral around the longitudinal axis may vary in pitch. This pitch may be reduced to zero, i.e. to the point where the spiral ends and contacts itself by forming a full convolution. In addition, in all embodiments of the present invention, the pore size may be uniform throughout the device, ie from one end of the device to the other end of the device.

  By using the blood vessel embolus capturing device and method of the present invention, blood in the blood vessel can be filtered very effectively for capturing blood clots and preventing embolism, and also obstructing blood flow. Absent. In the present invention, high clot capture efficiency is achieved while minimizing the risk of increased pressure gradient. Thus, serious and fatal complications associated with treatment, particularly complications that may cause pulmonary embolism and blood clots, can be eliminated.

  The novel features of the invention are set forth with particularity in the appended claims. However, the invention itself, both in terms of construction and operation, together with other objects and advantages thereof, can be understood by reading the following description in conjunction with the accompanying drawings.

  The present invention is a filter device, generally designated 50, in a spiral design, which is an arbitrary generally cylindrical path, blood vessel 10 such as a vein or artery in a human body (FIGS. 1A and 1B). For example, a surface type filter (FIGS. 1A, 1B, 2A, 2B, 4A and 4B) or a deep filter (FIGS. 3A and 3B) that can be used in a vena cava or a conduit or organ. ). The filter device 50 and methods of using the device 50 are particularly useful for filtering the vena cava and are particularly useful for the treatment of vascular diseases such as DVT. The instrument 50 and its method of use are not limited to this particular anatomical structure or disease state.

  The filter device 50 has a helix 55 (either as a single helix or a double helix as will be described below) that moves or circulates throughout the patient's circulatory system. Or is particularly useful for collecting and capturing blood clots, emboli, particulates, particles and thrombus that may tear off the attached tissue or structure in the body and move or circulate throughout the patient's circulatory system. As defined herein, “(one) clot”, “(plural) clot”, “(one) embolism”, “embolism”, “(plural) embolism”, “patty” The terms “curate”, “particulate”, “substance”, “particle”, “filtrate”, “(one) thrombus” and “(multiple) thrombus” have the same meaning for the purposes of this disclosure. However, it is used interchangeably throughout the specification, and is indicated generally by the numeral 20.

  The spiral body 55 of the filter device 50 is made of a mesh material 52, and the entire mesh 52 is provided with a plurality of pores 53. For example, the mesh 52 has a plurality of interlocking strands or fibers or rows of pores 53 that are made or arranged in the material 52 itself, such as by cutting, etching, stamping, or the like. Details of the pores 53 will be described below.

  The material 52 is an arbitrary form of material. In one embodiment, material 52 is a self-expanding material, such as a shape memory material, which may be a metal alloy, such as a nickel titanium alloy alloy (Nitinol). In another embodiment, material 52 is a stainless steel alloy. As a variant, the mesh material 52 is a polymer material. The polymer may be biodegradable and / or bioabsorbable. As used herein, the term “biodegradable” refers to the state in which a material or component becomes a product, by-product, component or subcomponent over time, for example days, weeks, months or years. Defined as the decomposition or sensitivity of a material or component that decomposes or breaks. “Bioresorbable” as used herein is defined as the biological removal of degradation products by metabolism and / or excretion.

  The expanded shape of the filter 50 is at least one helix 55, such as a single helix (FIGS. 1A, 1B, 2A, 2B, 3A and 3B) or a double helix (FIGS. 4A and 4B). including. The single helix 55 and the double helix 55 each have a plurality of pleats or panels 60 arranged in a spiral around the longitudinal axis of the instrument 50 in some embodiments of the invention. The panel 60 is spirally arranged around the longitudinal axis in the state of a plurality of spiral turns 65. The spiral turn 65 defines an inner diameter (ID) and an outer diameter (OD), respectively. Alternatively, the spiral 55 of the instrument 50 may be a single piece of mesh material 52 or fused or joined together to form a single or double helix (FIGS. 4A and 4B) of the filter instrument 50. It consists of separate sections. The spiral turn 65 of the filter device may have a uniform pitch, or alternatively, a variable pitch depending on the channeling effect desired by the end user.

  The mesh 52 of each turn 65 has, for example, a slope from the ID of the illustrated spiral body 55 to the OD of the spiral body 55, and is preferably slanted, inclined, or curved, or as a modification, the spiral body 55 is There may be no inclination towards the longitudinal axis. Since the mesh 52 is inclined from ID to OD or curved outward for each turn 65 of the spiral body 55, the fluid medium is pushed toward the outer peripheral portion of the spiral body 55 and circulates. The panel 60 design for the helical body 52 of the embodiment shown in FIGS. 1A and 1B facilitates this outwardly inclined feature and outward fluidic channeling effect.

The spiral 55 has a plurality of turns 65 arranged in a spiral around the longitudinal axis, and these turns may change the pitch. This pitch may be reduced to zero, i.e. where the helix 55 ends or terminates by forming a complete convolution and contacts itself.

  In some embodiments of the present invention, the helix 55 has a spinal member 57 as best shown in FIGS. 3A and 3B. The spine member 57 serves as a central longitudinal shaft or axis for the helical turn 65 of the helical body 55. Use of the spine member 57 is optional for the spiral 55. This is because the helical body 55 can be configured without this feature.

  The filter device 50 is expandable from a compressed state, a closed state, a pre-deployment state, or a collapsed state, for example, to an open state, a deployed state, or an expanded state partially illustrated in FIGS. 5B and 5C. For example, with respect to the embodiment with a plurality of panels 60 shown in FIGS. 1A and 1B, the panel 60 of the mesh 52 is circumferential when the instrument 50 is deployed as best shown by the directional arrows in FIG. 5B. Extend in the direction. The filter device 50 is introduced into the lumen 15 of the blood vessel 10 in a compressed state, a closed state, a pre-deployment state or a collapsed state, and the spiral body 55 is movably expanded to an open state, a deployed state, or an expanded state. In the lumen 15 of the blood vessel 10. When moved to the open, deployed or expanded state, the ID of the helix 55 is generally aligned along the longitudinal axis of the blood vessel 10 and the OD of the helix 55 is located adjacent to the inner wall 12 of the blood vessel 10.

  In addition, when moved to the open, deployed or expanded state, the helix 55 itself digs into the wall 12 of the blood vessel 10, for example as shown in FIGS. 1A and 1B. As best shown in FIGS. 2B, 3B and 4B, an anchoring mechanism 68, such as a plurality of barbs 68, is used to secure the helix 55 into the tissue, eg, the wall 12 of the blood vessel 10. ing.

  The size of each pore 53 is 120 μm or more. In addition, in all embodiments of the present invention, the size of the pores may be uniform over the entire length of the instrument 50, ie from one end of the instrument 50 to the other end of the instrument 50.

  The filter device 50 (all embodiments) of the present invention can expose a large surface area of the filter device 50 due to the unique features of the helix 55. The filter device 50 allows the realization of a small pore structure 53 (compared to known filters and filtration methods) based on its helical design. This is because there is no fear of stopping the venous flow. Thus, a small clot 20 can be targeted and captured, for example a clot 20 of size ≧ 120 μm, thereby reducing the risk to the patient, ie the risk of the small clot 20 causing harm. Can be made.

  Further, in all embodiments of the present invention, the pore size of the filter device 50 may vary from one end of the device 50 to the other end of the device 50. For example, as best shown in FIGS. 3A and 3B, the pore size ranges from a large size pore at one end of the instrument (eg, a 5 mm pore size) to a smaller size at the other end of the instrument 50. May vary up to pore 53 (eg, 120 μm pore size), so the pore size decreases over the entire length of the device 50, ie, the pore size decreases from one end of the device 50 to the other, This extends the useful life of the instrument 50 found, for example, in a deep filter instrument. The large clot 20 is captured at the beginning of the helix 55 of the filter device 50 and a small pore structure at the opposite or far end of the helix 55 of the filter device 50 to remove the small clot 20. Take a part and put it.

  The structure of the spiral 55 is an expanded mesh 52 that creates a surface-type filter effect. Any particles or clot 20 that approach the filter device 50 of the present invention will encounter what appears to be a solid cylindrical obstruction in the lumen 15 of the blood vessel 10 (the OD of the helix 55 is shown in FIG. 1A and As best shown in FIG. 1B, it is expanded circumferentially to the inner wall 12 of the blood vessel 10 to conform to its shape in the circumferential direction). However, the helical twist of the helical body 55 allows a low viscosity fluid medium (eg, blood) to flow around the mesh 52 through the pores 53. The particles or clot 20 present in the fluid flow hits the mesh 52 of the spiral body 55 and is trapped therein or pushed toward the outer peripheral portion of the spiral body 55 by the flow effect due to the centrifugal force of the spiral. The helical structure of the filter device 50 of the present invention also induces an outward force by the outward curve or slope of the mesh 52, and the particles or clot 20 are trapped in this outward curve or slope. It will be. The fluid (blood) can move freely around the clot 20 and pass through it even if the filter structure is completely covered by particles or clot 20.

  The spiral filter design of the filter device 50 of the present invention has several advantages, for example, the spiral 55 of the filter device 50 filters a large amount of filtrate (blood clot 20) and the blood vessel 10, ie, the vena cava in this example. Clogging or blockage of ten lumens 15 can be completely avoided. This increases the resistance in the lumen 15 of the blood vessel 10 and eventually the flow in the blood vessel 10 when the prior art filter is eventually clogged or occluded by particulate matter (clot 20). It is particularly important because it restricts and thereby completely cuts off or stops the fluid flow.

  The helical filter design of the filter device 50 of the present invention captures the filtrate 20 by inertial collision, or diverts it to the outer edge or outer periphery of the helical body 55 and thereby captures it, along with the fluid medium (liquid or gas). ) Can pass around new obstacles created by the captured filtrate 20.

  Another advantage of the filter device 50 of the present invention is that, as shown in FIGS. 3A and 3B, a filter having different pore sizes from beginning to end, similar to a deep layer filter, thereby extending life. Can be configured. Due to this variable pore size (along the length of the instrument 50), large clots 20 are captured at the beginning of the filter where the size of the pores 53 is large and the filter's small fines are removed to remove the small clot 20. The hole structure part will be set aside.

  Other advantages of the filter device 50 of the present invention relate to its transport, transportability and manufacturability. For example, as shown in FIG. 5A, in the case of an embodiment of the invention made of a shape memory material, for example a nickel titanium alloy, for example, the shape memory alloy is used as the structure of the filter 50 itself, As will be described in an easy-to-understand manner, this also serves as a transport function for the filter 50.

  As shown in FIG. 5A, the filter device 50 may be laser cut from a tube of shape memory material (in this example, nickel titanium alloy) to the overall shape of the ribbon. The final cut shape obtained from the shape memory tube 40 is generally similar to a ribbon as best shown in FIG. A cut instrument 50 (ribbon-like at this point) is attached to the shaft 82 of the catheter 80, which is similar to holding the ribbon in hand and wrapping it around a pencil. The instrument 50 is mounted on the shaft 82 by advancing the shaft 82 while circumferentially wrapping the cut instrument 50 around the shaft 82 so that the instrument 50 does not overlap itself, thereby following a spiral pattern. A cover 85 is used on the catheter 80 to keep the wound-mounted instrument 50 compressed in its compressed, closed, pre-deployed or crushed state, although this is optional. is there.

  One geometric shape that is merely used as an example is shown in FIGS. 5A, 5B, and 5C, where the initial shape of the instrument 50 appears to have been cut from the ribbon (FIG. 5A). However, when expanded, one side / edge expands more than the other, thereby creating a circular path (FIGS. 5B and 5C). When an axial direction component is given to the circular path, a spiral filter shape (spiral body 55) of the filter device 50 is obtained.

  Therefore, as shown in FIG. 6, the filter device 50 of the present invention provides a very simple transport method, so that the flexibility of the transport method can be obtained. The helical shape (helix 55, ie a single or double helix design) inherently matches the shape of the shaft 82 of the catheter 80 and can achieve a tight bend radius as shown. Thus, the filter device 50 is self-aligning and can function in a very thin and easily bent environment.

  In addition, variations of the filter device 50 of the present invention are also contemplated herein. For example, as described above, the spiral turn 65 of the filter device 50 may have a variable pitch. In addition, one end of the filter device 50 may itself be coiled, thereby providing an absolute filter, thus eliminating the perception that the clot 20 is passing through the filter 50.

  Further, the filter device 50 is optionally coated with a drug, such as a cytotoxic drug or a cytostatic drug. Its purpose is to make the filter device 50 a drug eluting device for the treatment of diseases that respond to cytotoxic agents (eg, paclitaxel) or cytostatic agents (eg, one of various rapamycins). There is. As used herein, “(one) agent” or “(agent)” is used interchangeably herein and refers to some degree of therapeutic effect (often beneficial effect), eg, as two examples It means an agonist, a drug, a preparation, a substance composition or a mixture thereof that brings about an effect that is cytotoxic or cytostatic.

  These include pesticides, herbicides, fungicides, biocides, algicides, rodenticides, fungicides, insecticides, antioxidants, plant growth promoters, plant growth inhibitors, preservatives, antiseptics, disinfectants Medicines, sterilants, catalysts, chemical agents, fermentants, foods, food supplements, nutrients, cosmetics, pharmaceuticals, vitamins, infertility agents, fertilization inhibitors, fertilizers, microbial attenuators and others Of these agents. As used herein, the term includes physiologically or pharmacologically active substances that produce one or more local or systemic effects in animals, such as warm-blooded mammals, humans And primates, birds, poultry or livestock such as cats, dogs, sheep, goats, cattle, horses and pigs, laboratory animals such as mice, rats and guinea pigs, fish, reptiles, zoos and wild animals. Active agents that can be delivered include inorganic and organic compounds, such as peripheral nerves, adrenergic receptors, cholinergic receptors, skeletal muscle, cardiovascular system, smooth muscle, blood circulation system, junctions, nerves Examples include, but are not limited to, agents acting on the effector junction, endocrine system, hormone system, immune system, reproductive system, skeletal system, local hormone system, digestive system, excretory system, histamine system and central nervous system. . Suitable agents are, for example, proteins, enzymes, hormones, polynucleotides, nucleoproteins, polysaccharides, glycoproteins, lipoproteins, polypeptides, steroids, hypnotics, sedatives, psychic energizers, tranquilizers , Anticonvulsants, muscle relaxants, antiparkinson drugs, analgesics, anti-inflammatory agents, local anesthetics, muscle contractants, blood pressure drugs, cholesterol-lowering agents including statins, antibacterial agents, antimalarials, contraception Drugs, sympathomimetics, hormones including polypeptides and proteins that can induce physiological effects, diuretics, lipid regulators, antiandrogens, anthelmintics, tumor agents, antitumor agents, hypoglycemic agents, nutritional agents , Supplements, growth supplements, fats, eye medications, anti-enteritis agents, electrolytes, diagnostics.

  Examples of therapeutic agents or drugs useful in the present invention include prochlorperazine edicylate, ferrous sulfate, aminocaproic acid, mecamylamine hydrochloride, procainamide hydrochloride, amphetamine sulfate, methamphetamine hydrochloride, benzphetamine hydrochloride, isoproteronol sulfate (Isoproteronol sulfate), phenmetrazine hydrochloride, betanecol chloride, methacholine chloride, pilocarpine hydrochloride, atropine sulfate, scopolamine bromide, isopropamide iodide, tridihexetyl chloride, phenformin hydrochloride, methylphenidate hydrochloride, theophylline cholinate, Cephalexin hydrochloride, diphenidol, meclizine hydrochloride, prochlorperazine maleate, phenoxybenzamine, cetylperazine maleate, anisindione, diphenadione, erythronitrile Trityl, digoxin, isofluorophosphoric acid, acetazolamide, metazolamide, bendroflumesiazide, chlorpropamide, tolazamide, chlormadinone acetate, phenacrycodol, allopurinol, aspirin aluminum, methotrexate, acetylsulfixazole, hydrocortisone, hydrocorticosterone acetate, Cortisone acetate, dexamethasone and its derivatives, such as betamethasone, triamcinolone, methyltestosterone, 17-.beta.-estradiol, ethinylestradiol, ethinylestradiol 3-methylether, prednisolone, 17-beta-hydroxyprogesterone acetate (17-.beta.-hydroxyprogesterone acetate), 19-norprogesterone, norgestrel, noreth Delon, Norethisterone, Norethiederone, Progesterone, Norgesterone, Norethinodrel, Indomethacin, Naproxen, Fenoprofen, Sulindac, Indoprofen, Nitroglycerin, Isosorbide nitrate, Propranolol, Timolol, Atenolol, Alprenolol, Clonidine, imipramine, levodopa, chlorpromazine, methyldopa, dihydroxyphenylalanine, theophylline, calcium gluconate, ketoprofen, ibuprofen, atorvastatin, simvastatin, pravastatin, fluvastatin, lovastatin, cephalexin, erythromycin, haloperidol, haloperidol Ferrous iron, Vincamine (vinca mine), phenoxybenzamine, diltiazem, milrinone, captropril, mandol, quanbenz, hydrochlorothiazide, ranitidine, flurbiprofen, fenbufen, fluprofen, tolmethine, alclofenac , Mefenamic, flufenamic, difuninal, nimodipine, nitrendipine, nisoldipine, nicardipine, felodipine, lidoflazine, tiapamil, gallopamil, amlodipine, mioflazine, mioflazine, mioflazine Captopril, ramipril, enalaprilate, famotidine, nizatidine, sucralfate, ethinidine, tetratolol, Nokishijiru, chlordiazepoxide, diazepam, amitriptyline, imipramine. Another example is proteins and peptides, such as insulin, colchicine, glucagon, thyroid stimulating hormone, parathyroid hormone, pituitary hormone, calcitonin, renin, prolactin, corticotropin, thyroid hormone, follicle stimuli Hormone, Chorionic Gonadotropin, Gonadotropin Releasing Hormone, Bovine Somatropin, Porcine Somatropin, Oxytocin, Vazopressin, Prolactin, Growth Hormone Inhibitory Hormone, Ripressin, Pancreothymine, Lutein Hormone, LHRH, Interferon, Interleukin, Growth Hormones such as human growth hormone, bovine growth hormone, porcine growth hormone, fertilization inhibitors such as prostaglandins, fertilization promoters, growth factors, human pancreatic hormones It includes out factors, but not limited to.

Further, useful agents or therapeutic agents for the filter device 50 include natural products such as vinca alkaloids (ie, vinblastine, vincristine, vinorelbine), paclitaxel, epidipodophyllotoxins (ie, etoposide, Teniposide), antibiotics (dactinomycin (actinomycin D), daunorubicin, doxorubicin, idarubicin), anthracycline, mitoxantrone, bleomycin, primycin (mitromycin), mitomycin, enzyme (L-asparagine systemically metabolized) and, take away the cells without the ability to synthesize asparagine itself L- asparaginase), antiplatelet agents such as G (GP) II _b III _a inhibitors, anti-proliferative / antimitotic such vitronectin receptor antagonists Cleavage agents: nitrogen mustard (mechloretamine, cyclophosphamide and its analogs, melphalan, chlorambucil), ethylenimines, methylmelamine (hexamethylmelamine, thiotepa), alkyl sulfonates-busulfan Anti-proliferative / anti-mitotic alkylating agents such as nirtosoureas (carmustine (BCNU) and analogues, streptozocin), trazenes-decarbazine (DTIC); folic acid analogues (methotrexate), pyrimidine analogues Anti-proliferation / anti-mitosis such as (fluorouracil, flocuridine, cytarabine), purine analogs and related inhibitors (mercaptopurine, thioguanine, pentostatin, 2-chlorodeoxyadenosine {Cladribine}) Antagonists; platinum coordination compounds (complexes) (cisplatin, carboplatin), procarbazine, hydroxyurea, mitotane, aminoglutethimide, hormones (ie estrogens), anticoagulants (heparin, synthetic heparin salts and thrombin) Inhibitors), thrombolytic agents (eg tissue plasminogen activator, streptokinase, urokinase), aspirin, dipyridamole, ticlopidine, clopidogrel, abciximab, antimigratory drugs, antisecretory drugs (Breveldin; anti-inflammatory drugs such as corticosteroids (cortisol, cortisone, fludrocortisone, prednisone, prednisolone, 6α-methylfuredonizolone, triamcinolone, betamethasone, dexamethasone), non-steroids (Salicylic acid derivatives i.e. aspirin, paraaminophenol derivatives i.e. acetominophen, indole, indene acetic acids (indomethacin, sulindac, etodalac), heteroaryl acetic acids (tolmethine, Diclofenac, ketorolac), arylpropionic acid (ibuprofen and derivatives), anthranilic acid (mefenamic acid, meclofenamic acid), enolic acids (piroxicam, tenoxicam, phenylbutazone, oxyphenthatrazone), nabumetone, Gold compounds (auranofin, aurothioglucose, gold sodium thiomalate); immunosuppressants (cyclosporine, tacrolimus (FK-506), sirolimus (rapamycin), a Thiopurine, mycophenolate mofetil); angiogenic agents such as vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), platelet derived growth factor (PDGF), erythropoietin, angiotensin receptor Blockers, nitric oxide donors, anti-sense oligionucleotides and mixtures thereof, cell cycle inhibitors, mTOR inhibitors, growth factor signaling kinase inhibitors, chemical formulations, biomolecules, nucleic acids, eg Examples include DNA and RNA, amino acids, peptides, proteins or mixtures thereof.

  It is understood that the term “(one) agent” or “(agent)” includes all derivatives, analogs and salts thereof and does not exclude the use of two or more such agents. Should.

  One or more agents are applied to the filter device 50 itself, or any desired portion of the device 50, such as the outer periphery of the spiral turn 65. Further, the drug may be used with a polymer coating, or if the mesh material 52 itself is made of a polymer material as described above, the drug may be mixed into the mesh material 52 of the device 50.

  As shown in FIGS. 2B, 3B and 4B, the filter device 50 may alternatively be a securing mechanism 68 along the outer periphery of the helix 55, ie, the turn 65, to facilitate anchoring or anchoring to the vessel wall 12. For example, with sharp edges or stabs. In addition, the instrument 50 of the present invention is also intended to have any other type of attachment mechanism suitable for the intended environment.

  As described above, the deployment mechanism of the filter device 50 is due to the material 52 itself (if the material 52 is a shape memory material) and is either a spiral wound tube (FIG. 6) or a compression disc (FIG. (Not shown). The delivery device may be a structure composed solely of the compressed filter device 50 itself, or alternatively, the filter device 50 may be delivered to a delivery mechanism (eg, a delivery tube or catheter 80, in which case the filter device is a catheter). 80 may be inserted between the shaft 82 and the cover 85 in a compressed state.

  The mesh material 52 may vary in any form, i.e., from a self-expanding material, such as Nitinol, to a stainless steel material that requires a transport mechanism to form into a final shape, or to name a few. It can be a polymer or a blend of polymers. The filter device is also made to be retractable (if desired). For example, due to the nature of the helical design, the filter device 50 is crushed by applying a twisting action (inverse torque) that is the reverse of the twisting action that expands the filter instrument when originally deployed in the blood vessel 10. It can be withdrawn and removed from the blood vessel 10 and the patient's body. The material 52 may also be of a type that requires a transport mechanism to form the filter device 50 into its final helical shape.

  It will be understood that variations and modifications of the invention can be devised in accordance with the disclosed principles of the invention without departing from the scope of the invention, so long as the above description relates to preferred embodiments of the invention.

  While preferred embodiments of the present invention have been disclosed, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Those skilled in the art will envision many variations, modifications and substitutions without departing from the scope of the invention. Accordingly, the invention is limited only by the spirit and scope of the invention as set forth in the appended claims.

Specific embodiments of the present invention are as follows.
(1) A device for capturing an embolus in a blood vessel in a patient's body,
Having at least one helix made of mesh material;
The at least one helix has a plurality of turns helically arranged about a longitudinal axis;
The mesh material is provided with a plurality of pores,
The instrument has a pore size of 120 μm or more.
(2) The instrument according to the embodiment (1), wherein the at least one spiral body includes a plurality of panels.
(3) The instrument according to the embodiment (2), wherein the panel can move from a collapsed state to an expanded state when placed in a blood vessel.
(4) The instrument according to embodiment (3), wherein the mesh material includes a self-expanding material.
(5) The instrument according to embodiment (4), wherein the self-expanding material includes a shape memory material.

(6) The instrument according to the embodiment (5), wherein the shape memory material includes a metal alloy.
(7) The instrument according to the embodiment (6), wherein the metal alloy includes a nickel titanium alloy.
(8) The instrument according to the embodiment (3), wherein the mesh material includes stainless steel.
(9) The instrument of embodiment (4), wherein the self-expanding material comprises a polymer.
(10) The device according to embodiment (9), wherein the polymer is biodegradable.

(11) The device according to the embodiment (10), wherein the polymer is bioabsorbable.
(12) The device according to the embodiment (11), further comprising a medicine.
(13) The device according to the embodiment (9), further including a drug.
(14) The device according to the embodiment (12), wherein the drug is cytostatic.
(15) The device according to embodiment (14), wherein the drug is rapamycin.

(16) The device according to the embodiment (12), wherein the drug is cytotoxic.
(17) The device according to embodiment (16), wherein the drug is paclitaxel.
(18) The device according to the embodiment (13), wherein the drug is cytostatic.
(19) The device according to embodiment (18), wherein the drug is rapamycin.
(20) The instrument according to the embodiment (1), further including at least one fixing mechanism provided on the at least one spiral body.

(21) The instrument according to embodiment (20), wherein the at least one fixing mechanism has at least one barb.
(22) The instrument according to embodiment (1), wherein the at least one helix includes a double helix.
(23) The instrument according to the embodiment (22), further including at least one fixing mechanism provided in the double helix.
(24) The instrument according to embodiment (23), wherein the at least one fixing mechanism has at least one barb.
(25) The instrument of embodiment (22), wherein the at least one helix comprises a plurality of panels.

(26) The instrument of embodiment (25), wherein the panel is capable of moving from a collapsed state to an expanded state when placed in a blood vessel.
(27) The instrument of embodiment (26), wherein the mesh material comprises a self-expanding material.
(28) The device of embodiment (27), wherein the self-expanding material comprises a shape memory material.
(29) The instrument according to embodiment (28), wherein the shape memory material includes a metal alloy.
(30) The instrument according to the embodiment (29), wherein the metal alloy includes a nickel titanium alloy.

(31) The instrument according to embodiment (29), wherein the mesh material includes stainless steel.
(32) The device of embodiment (27), wherein the self-expanding material comprises a polymer.
(33) The device according to embodiment (32), wherein the polymer is biodegradable.
(34) The device according to embodiment (33), wherein the polymer is bioabsorbable.
(35) The device according to the embodiment (34), further comprising a drug.

(36) The device according to the embodiment (32), further comprising a drug.
(37) The device according to the embodiment (35), wherein the drug is cytostatic.
(38) The device according to embodiment (37), wherein the drug is rapamycin.
(39) The device according to the embodiment (35), wherein the drug is cytotoxic.
(40) The device according to the embodiment (39), wherein the drug is paclitaxel.

(41) The device according to the embodiment (36), wherein the drug is cytostatic.
(42) The device according to the embodiment (41), wherein the drug is rapamycin.
(43) The device according to the embodiment (36), wherein the drug is cytotoxic.
(44) The device according to embodiment (43), wherein the drug is paclitaxel.
(45) The instrument according to embodiment (25), further including at least one fixing mechanism provided on the at least one spiral body.

(46) The instrument according to embodiment (45), wherein the at least one fixing mechanism has at least one barb.
(47) The instrument according to embodiment (1), further including a spinal column member.
(48) The instrument according to embodiment (22), further comprising a spinal column member.
(49) The instrument according to embodiment (1), wherein the pores change in size from one end of the at least one helical body to the other end of the at least one helical body.
(50) The instrument of embodiment (49), wherein the pores vary in size from a large size at the one end of the at least one helix to a small size at the other end of the at least one helix. .

(51) The instrument according to the embodiment (22), wherein the size of the pore changes from one end of the double helix to the other end of the double helix.
(52) The device according to the embodiment (51), wherein the pores are changed in size from a large size at the one end of the double helix to a small size at the other end of the double helix.
(53) The instrument according to embodiment (49), wherein the pitch of the at least one helical body changes in size from the one end of the at least one helical body to the other end of the at least one helical body.
(54) The embodiment, wherein the pitch of the at least one helix varies from a large size at the one end of the at least one helix to a small size at the other end of the at least one helix. 53) The instrument of description.
(55) The instrument according to embodiment (1), wherein the pitch of the at least one helical body changes in size from one end of the at least one helical body to the other end of the at least one helical body.

(56) The embodiment, wherein the pitch of the at least one helical body changes in size from a large size at the end of the at least one helical body to a small size at the other end of the at least one helical body. (55) The instrument of description.
(57) A device for capturing an embolus in a blood vessel,
Having a plurality of mesh panels that can move from a crushed state to an expanded state when placed in a blood vessel;
When the mesh panel is in an expanded state, it forms a plurality of turns arranged in a spiral around the longitudinal axis;
The mesh panel is provided with a plurality of pores, and the pore size is 120 μm or more.
(58) The instrument of embodiment (57), wherein the mesh panel comprises a self-expanding material.
(59) The device of embodiment (58), wherein the self-expanding material comprises a shape memory material.
(60) The instrument according to embodiment (59), wherein the shape memory material includes a metal alloy.

(61) The instrument according to the embodiment (60), wherein the metal alloy includes a nickel titanium alloy.
(62) The instrument according to embodiment (57), wherein the mesh material includes stainless steel.
(63) The device of embodiment (58), wherein the self-expanding material comprises a polymer.
(64) The device according to embodiment (63), wherein the polymer is biodegradable.
(65) The device according to embodiment (64), wherein the polymer is bioabsorbable.

(66) The device according to the embodiment (65), further comprising a drug.
(67) The device according to the embodiment (63), further comprising a drug.
(68) The device according to the embodiment (66), wherein the drug is cytostatic.
(69) The device according to embodiment (68), wherein the drug is rapamycin.
(70) The device according to the embodiment (66), wherein the drug is cytotoxic.

(71) The device according to embodiment (70), wherein the drug is paclitaxel.
(72) The device according to the embodiment (67), wherein the drug is cytostatic.
(73) The device according to the embodiment (72), wherein the drug is rapamycin.
(74) The device according to embodiment (67), wherein the drug is cytotoxic.
(75) The device according to embodiment (74), wherein the drug is paclitaxel.

(76) The instrument according to embodiment (57), further comprising at least one fixing mechanism provided on the at least one spiral body.
(77) The instrument of embodiment (76), wherein the at least one securing mechanism comprises at least one barb.
(78) The instrument according to the embodiment (57), further including a spinal member.
(79) The instrument according to embodiment (57), wherein the pores change in size from one end of the at least one helix to the other end of the at least one helix.
(80) The instrument of embodiment (79), wherein the pores vary in size from a large size at the one end of the at least one helix to a small size at the other end of the at least one helix. .

(81) The instrument of embodiment (79), wherein the pitch of the at least one helix varies in size from one end of the at least one helix to the other end of the at least one helix.
(82) In the embodiment, the pitch of the at least one helical body is changed in size from a large size at the one end of the at least one helical body to a small size at the other end of the at least one helical body. 81) The instrument according to the above.
(83) The instrument of embodiment (57), wherein the pitch of the at least one helix varies in size from one end of the at least one helix to the other end of the at least one helix.
(84) The embodiment wherein the pitch of the at least one helix varies in size from a large size at the one end of the at least one helix to a small size at the other end of the at least one helix. 83) The device according to the above.
(85) A device for capturing an embolus in a blood vessel,
Having a plurality of mesh panels that can move from a crushed state to an expanded state when placed in a blood vessel;
When the mesh panel is in an expanded state, the mesh panel forms a double spiral structure and forms a plurality of turns arranged in a spiral around the longitudinal axis;
The mesh panel is provided with a plurality of pores,
The instrument has a pore size of 120 μm or more.

(86) The instrument of embodiment (85), wherein the mesh panel comprises a self-expanding material.
(87) The device of embodiment (86), wherein the self-expanding material comprises a shape memory material.
(88) The instrument according to embodiment (87), wherein the shape memory material includes a metal alloy.
(89) The instrument according to the embodiment (88), wherein the metal alloy includes a nickel titanium alloy.
(90) The instrument according to embodiment (85), wherein the mesh material includes stainless steel.

(91) The instrument of embodiment (86), wherein the self-expanding material comprises a polymer.
(92) The device of embodiment (91), wherein the polymer is biodegradable.
(93) The device of embodiment (92), wherein the polymer is bioabsorbable.
(94) The device according to the embodiment (93), further comprising a medicine.
(95) The device according to the embodiment (91), further comprising a drug.

(96) The device according to the embodiment (94), wherein the drug is cytostatic.
(97) The device according to embodiment (96), wherein the drug is rapamycin.
(98) The device according to the embodiment (94), wherein the drug is cytotoxic.
(99) The device according to embodiment (98), wherein the drug is paclitaxel.
(100) The device according to the embodiment (95), wherein the drug is cytostatic.

(101) The device according to embodiment (100), wherein the drug is rapamycin.
(102) The device according to embodiment (95), wherein the drug is cytotoxic.
(103) The device according to embodiment (102), wherein the drug is paclitaxel.
(104) The instrument of embodiment (85), further comprising at least one securing mechanism provided in the double helix structure.
(105) The instrument of embodiment (104), wherein the at least one securing mechanism comprises at least one barb.

(106) The instrument of embodiment (85), further comprising a spinal member.
(107) The instrument according to embodiment (85), wherein the pores change in size from one end of the at least one spiral to the other end of the at least one spiral.
(108) The instrument of embodiment (107), wherein the pores vary in size from a large size at the one end of the at least one helix to a small size at the other end of the at least one helix. .
(109) The instrument of embodiment (107), wherein the pitch of the at least one helix varies in size from one end of the at least one helix to the other end of the at least one helix.
(110) The embodiment wherein the pitch of the at least one helix varies in size from a large size at the one end of the at least one helix to a small size at the other end of the at least one helix. 109).

(111) The instrument of embodiment (85), wherein the pitch of the at least one helix varies in size from one end of the at least one helix to the other end of the at least one helix.
(112) The embodiment wherein the pitch of the at least one helix varies in size from a large size at the one end of the at least one helix to a small size at the other end of the at least one helix. 111).
(113) A method of capturing an embolus in a blood vessel in a patient's body,
Having at least one helix made of mesh material, the at least one helix having a plurality of turns arranged helically around a longitudinal axis, the mesh material having a plurality of pores Providing an instrument, wherein the pore size is 120 μm or more;
Placing the device in a blood vessel in a patient's body.
114. The method of embodiment 113, comprising placing the device in a blood vessel of a patient's body by moving the device from a collapsed state to an expanded state when the device is placed in the blood vessel.
(115) The method of embodiment (114), further comprising securing the device to the inner wall of a blood vessel.

(116) The method of embodiment (115), further comprising the step of securing the device to the inner wall of a blood vessel using a plurality of stabs.
(117) The method according to the embodiment (114), wherein the instrument is placed in a blood vessel by using a delivery catheter.
(118) The method of embodiment (113), further comprising eluting at least one agent from the device.
(119) The method of embodiment (118), further comprising eluting at least one cytostatic drug from the device.
(120) The method of embodiment (119), further comprising the step of eluting rapamycin from the device.

(121) The method of embodiment (118), further comprising eluting at least one cytotoxic agent from the device.
(122) The method according to the embodiment (121), further comprising the step of eluting paclitaxel from the device.
123. The method of embodiment 114, further comprising moving the device from a collapsed state to an expanded state using a self-expanding material.
(124) The method of embodiment (123), further comprising moving the device from a collapsed state to an expanded state using a shape memory material.
125. The method of embodiment 124, further comprising using a metal alloy to move the device from a collapsed state to an expanded state.

126. The method of embodiment 125, further comprising moving the instrument from a collapsed state to an expanded state using a nickel titanium material.
(127) The method of embodiment (114), further comprising moving the instrument from a collapsed state to an expanded state using a stainless steel material.
128. The method of embodiment 123, further comprising moving the device from a collapsed state to an expanded state using a polymeric material.
129. The method of embodiment 128, further comprising moving the device from a collapsed state to an expanded state using a biodegradable polymer material.
(130) The method of embodiment (129), further comprising moving the device from a collapsed state to an expanded state using a bioabsorbable polymer material.

(131) A method of capturing an embolus in a blood vessel of a patient's body,
Having at least one helix made of mesh material, said at least one helix having a plurality of turns arranged in a spiral around a longitudinal axis, said mesh material having a plurality of pores The pore size is 120 μm or more, and the pore size varies from a large size at one end of the at least one helix to a small size at the other end of the at least one helix. Preparing the instrument,
Placing the device in a blood vessel in a patient's body;
Having a method.
(132) The method of embodiment (131), comprising placing the device in a blood vessel of a patient's body by moving the device from a collapsed state to an expanded state when the device is placed in the blood vessel.
(133) The method according to the embodiment (132), further comprising the step of fixing the device to the inner wall of a blood vessel.
(134) The method according to the embodiment (133), further comprising the step of fixing the device to the inner wall of a blood vessel using a plurality of stabs.
(135) The method according to the embodiment (132), wherein the instrument is placed in a blood vessel by using a delivery catheter.

(136) The method of embodiment (131), further comprising eluting at least one agent from the device.
(137) The method of the above embodiment (136), further comprising the step of eluting at least one cytostatic drug from the device.
(138) The method of the above embodiment (137), further comprising eluting rapamycin from the device.
(139) The method of embodiment (136), further comprising eluting at least one cytotoxic agent from the device.
(140) The method of embodiment (139), further comprising the step of eluting paclitaxel from the device.

141. The method of embodiment 132, further comprising moving the device from a collapsed state to an expanded state using a self-expanding material.
(142) The method of embodiment (141), further comprising moving the device from a collapsed state to an expanded state using a shape memory material.
(143) The method of embodiment (142), further comprising moving the instrument from a collapsed state to an expanded state using a metal alloy.
(144) The method of embodiment (143), further comprising moving the instrument from a collapsed state to an expanded state using a nickel titanium material.
(145) The method of embodiment (132), further comprising moving the instrument from a collapsed state to an expanded state using a stainless steel material.

(146) The method of embodiment (141), further comprising moving the device from a collapsed state to an expanded state using a polymeric material.
(147) The method of embodiment (146), further comprising moving the device from a collapsed state to an expanded state using a biodegradable polymer material.
148. The method of embodiment 147, further comprising moving the device from a collapsed state to an expanded state using a bioabsorbable polymer material.
(149) A method of capturing an embolus in a blood vessel in a patient's body,
A plurality of mesh panels that can move from a crushed state to an expanded state when disposed in a blood vessel, and wherein the mesh panels are spirally disposed about a longitudinal axis when in the expanded state. Forming a turn, providing a device in which the mesh panel is provided with a plurality of pores, and the pore size is 120 μm or more;
Placing the device in a blood vessel in a patient's body.
(150) The embodiment (149), further comprising the step of placing the device in a blood vessel of a patient's body by moving the mesh panel of the device from a collapsed state to an expanded state when the mesh panel is placed in the blood vessel. the method of.

(151) The method according to the embodiment (150), further comprising the step of fixing the device to the inner wall of a blood vessel.
(152) The method according to the embodiment (151), further comprising fixing the device to the inner wall of a blood vessel using a plurality of stabs.
(153) The method according to the embodiment (150), wherein the device is placed in a blood vessel by using a delivery catheter.
(154) The method of embodiment (149), further comprising eluting at least one agent from the device.
(155) The method according to the embodiment (154), further comprising eluting at least one cytostatic drug from the device.

(156) The method of embodiment (155), further comprising eluting rapamycin from the device.
(157) The method of embodiment (154), further comprising eluting at least one cytotoxic agent from the device.
(158) The method of embodiment (157), further comprising eluting paclitaxel from the device.
159. The method of embodiment 150, further comprising using a self-expanding material to move the mesh panel of the device from a collapsed state to an expanded state.
160. The method of claim 159, further comprising using a shape memory material to move the mesh panel of the appliance from a collapsed state to an expanded state.

161. The method of embodiment 160, further comprising using a metal alloy to move the mesh panel of the appliance from a crushed state to an expanded state.
162. The method of embodiment 161, further comprising the step of moving the mesh panel of the appliance from a collapsed state to an expanded state using a nickel titanium material.
(163) The method of embodiment (150), further comprising moving the mesh panel of the instrument from a crushed state to an expanded state using a stainless steel material.
164. The method of embodiment 159, further comprising moving the mesh panel of the appliance from a collapsed state to an expanded state using a polymeric material.
(165) The method of embodiment (164), further comprising moving the mesh panel of the device from a collapsed state to an expanded state using a biodegradable polymer material.

(166) The method of embodiment (165), further comprising moving the mesh panel of the device from a collapsed state to an expanded state using a bioabsorbable polymer material.
(167) A method for capturing an embolus in a blood vessel in a patient's body,
Having a plurality of mesh panels that can move from a crushed state to an expanded state when placed in a blood vessel, and when the mesh panels are in an expanded state, form a double helical structure and spiral around a longitudinal axis Forming a plurality of turns arranged in a shape, the mesh panel is provided with a plurality of pores, and the size of the pores is 120 μm or more;
Placing the device in a blood vessel in a patient's body.
168. The embodiment of claim 167, comprising the step of placing the device in a blood vessel of a patient's body by moving the mesh panel of the device from a collapsed state to an expanded state when the mesh panel of the device is placed in the blood vessel. Method.
(169) The method of embodiment (168), further comprising securing the device to the inner wall of a blood vessel.
(170) The method of embodiment (169), further comprising the step of securing the device to the inner wall of a blood vessel using a plurality of stabs.

(171) The method of embodiment (168), wherein the device is placed in a blood vessel by using a delivery catheter.
(172) The method of embodiment (167), further comprising eluting at least one agent from the device.
(173) The method according to the embodiment (172), further comprising the step of eluting at least one cytostatic drug from the device.
(174) The method of embodiment (173), further comprising eluting rapamycin from the device.
(175) The method of embodiment (172), further comprising eluting at least one cytotoxic agent from the device.

(176) The method of embodiment (175), further comprising eluting paclitaxel from the device.
177. The method of embodiment 168, further comprising moving the device from a collapsed state to an expanded state using a self-expanding material.
(178) The method of embodiment (177), further comprising moving the mesh panel of the appliance from a collapsed state to an expanded state using a shape memory material.
(179) The method of embodiment (178), further comprising using a metal alloy to move the mesh panel of the appliance from a collapsed state to an expanded state.
(180) The method of embodiment (179), further comprising moving the mesh panel of the appliance from a collapsed state to an expanded state using a nickel titanium material.

(181) The method of embodiment (168), further comprising moving the mesh panel of the instrument from a crushed state to an expanded state using a stainless steel material.
(182) The method of embodiment (177), further comprising moving the mesh panel of the appliance from a collapsed state to an expanded state using a polymeric material.
(183) The method of embodiment (182), further comprising moving the mesh panel of the device from a collapsed state to an expanded state using a biodegradable polymer material.
(184) The method of embodiment (183), further comprising using a bioabsorbable polymer material to move the mesh panel of the device from a collapsed state to an expanded state.

  The method of the present invention is applied to the field of filtering blood in blood vessels for capturing blood clots and preventing embolism.

1 is a schematic diagram showing in cross-section a blood vessel provided with a helical filter device for capturing emboli according to the present invention. FIG. 2 is an enlarged view of a portion of the filter instrument blood vessel of FIG. 1 capturing emboli in a blood vessel in accordance with the present invention. 2 is a schematic illustration of another embodiment of the filter device of FIGS. 1A and 1B of the present invention. 2B is a schematic illustration of the filter device of FIG. 2A, showing the filter device including a plurality of fixation mechanisms for fixing the filter device to the inner wall of a blood vessel or organ in accordance with the present invention. 1A and 1B are schematic illustrations of another embodiment of the filter device of FIG. 1A and FIG. 1B, wherein the filter device has a graded pore size extending from one end of the filter device to the other end according to the present invention and is optionally used. It is a figure which shows the state which has a member. FIG. 3B is a schematic illustration of the filter device of FIG. 3A showing the filter device including a plurality of fixation mechanisms for fixing the filter device to the inner wall of a blood vessel or organ in accordance with the present invention. 1B is a schematic illustration of another embodiment of the filter device of FIGS. 1A and 1B having a double helix design in accordance with the present invention. 4B is a schematic illustration of the filter device of FIG. 4A showing the filter device including a plurality of securing mechanisms for securing the filter device to the inner wall of a blood vessel or organ in accordance with the present invention. FIG. (A), (B) and (C) are schematic diagrams showing a method of manufacturing and expanding the filter device of FIGS. 1A and 1B of the present invention. 1 is a schematic illustration of an apparatus for conveying a filter device of the present invention.

Explanation of symbols

10 blood vessels 12 blood vessel walls 15 lumens 20 blood clots 50 filter devices 52 mesh 53 pores 55 spirals 60 pleats or panels 65 turns

Claims (113)

A device for capturing emboli in blood vessels in a patient's body,
Having at least one helix made of mesh material;
The at least one helix has a plurality of turns helically arranged about a longitudinal axis;
The mesh material is provided with a plurality of pores,
The instrument has a pore size of 120 μm or more. The instrument of claim 1, wherein the at least one helix comprises a plurality of panels.   The instrument of claim 2, wherein the panel is capable of moving from a collapsed state to an expanded state when placed in a blood vessel.   The instrument of claim 3, wherein the mesh material comprises a self-expanding material.   The instrument of claim 4, wherein the self-expanding material comprises a shape memory material.   The instrument of claim 5, wherein the shape memory material comprises a metal alloy.   The instrument of claim 6, wherein the metal alloy comprises a nickel titanium alloy.   The instrument of claim 3, wherein the mesh material comprises stainless steel.   The device of claim 4, wherein the self-expanding material comprises a polymer.   The device of claim 9, wherein the polymer is biodegradable.   The device of claim 10, wherein the polymer is bioabsorbable.   12. The device of claim 11, further comprising a drug.   The device of claim 9 further comprising a medicament.   The device of claim 12, wherein the drug is cytostatic.   15. The device of claim 14, wherein the drug is rapamycin.   The device of claim 12, wherein the agent is cytotoxic.   The device of claim 16, wherein the drug is paclitaxel.   14. The device of claim 13, wherein the drug is cytostatic.   The device of claim 18, wherein the drug is rapamycin.   The instrument of claim 1, further comprising at least one securing mechanism provided on the at least one helix.   21. The instrument of claim 20, wherein the at least one securing mechanism comprises at least one barb.   The instrument of claim 1, wherein the at least one helix comprises a double helix.   23. The instrument of claim 22, further comprising at least one securing mechanism provided on the double helix.   24. The instrument of claim 23, wherein the at least one securing mechanism comprises at least one barb.   24. The instrument of claim 22, wherein the at least one helix includes a plurality of panels.   26. The instrument of claim 25, wherein the panel is capable of moving from a collapsed state to an expanded state when placed in a blood vessel.   27. The device of claim 26, wherein the mesh material comprises a self-expanding material.   28. The device of claim 27, wherein the self-expanding material comprises a shape memory material.   30. The device of claim 28, wherein the shape memory material comprises a metal alloy.   30. The instrument of claim 29, wherein the metal alloy comprises a nickel titanium alloy.   30. The instrument of claim 29, wherein the mesh material comprises stainless steel.   28. The device of claim 27, wherein the self-expanding material comprises a polymer.   35. The device of claim 32, wherein the polymer is biodegradable.   34. The device of claim 33, wherein the polymer is bioabsorbable.   35. The device of claim 34, further comprising a drug.   35. The device of claim 32, further comprising a drug.   36. The device of claim 35, wherein the agent is cytostatic.   38. The device of claim 37, wherein the drug is rapamycin.   36. The device of claim 35, wherein the agent is cytotoxic.   40. The device of claim 39, wherein the medicament is paclitaxel.   38. The device of claim 36, wherein the agent is cytostatic.   42. The device of claim 41, wherein the drug is rapamycin.   38. The device of claim 36, wherein the agent is cytotoxic.   44. The device of claim 43, wherein the medicament is paclitaxel.   26. The instrument of claim 25, further comprising at least one securing mechanism provided on the at least one helix.   46. The instrument of claim 45, wherein the at least one securing mechanism comprises at least one barb.   The instrument of claim 1, further comprising a spinal member.   24. The device of claim 22, further comprising a spinal member.   The instrument of claim 1, wherein the pores vary in size from one end of the at least one helix to the other end of the at least one helix.   50. The device of claim 49, wherein the pores vary in size from a large size at the one end of the at least one helix to a small size at the other end of the at least one helix.   23. The instrument of claim 22, wherein the pores vary in size from one end of the double helix to the other end of the double helix.   52. The device of claim 51, wherein the pores vary in size from a large size at the one end of the double helix to a small size at the other end of the double helix.   50. The instrument of claim 49, wherein the pitch of the at least one helix varies in size from the one end of the at least one helix to the other end of the at least one helix.   54. The instrument of claim 53, wherein the pitch of the at least one helix varies in size from a large size at the one end of the at least one helix to a small size at the other end of the at least one helix.   The instrument of claim 1, wherein the pitch of the at least one helix varies in size from one end of the at least one helix to the other end of the at least one helix.   56. The instrument of claim 55, wherein the pitch of the at least one helix varies in size from a large size at the end of the at least one helix to a small size at the other end of the at least one helix. . A device for capturing emboli in blood vessels,
Having a plurality of mesh panels that can move from a crushed state to an expanded state when placed in a blood vessel;
When the mesh panel is in an expanded state, it forms a plurality of turns arranged in a spiral around the longitudinal axis;
The mesh panel is provided with a plurality of pores, and the pore size is 120 μm or more.   58. The device of claim 57, wherein the mesh panel comprises a self-expanding material.   59. The device of claim 58, wherein the self-expanding material comprises a shape memory material.   60. The device of claim 59, wherein the shape memory material comprises a metal alloy.   61. The instrument of claim 60, wherein the metal alloy comprises a nickel titanium alloy.   58. The instrument of claim 57, wherein the mesh material comprises stainless steel.   59. The device of claim 58, wherein the self-expanding material comprises a polymer.   64. The device of claim 63, wherein the polymer is biodegradable.   65. The device of claim 64, wherein the polymer is bioabsorbable.   66. The device of claim 65, further comprising a medicament.   64. The device of claim 63, further comprising a drug.   68. The device of claim 66, wherein the agent is cytostatic.   69. The device of claim 68, wherein the drug is rapamycin.   68. The device of claim 66, wherein the agent is cytotoxic.   71. The device of claim 70, wherein the medicament is paclitaxel.   68. The device of claim 67, wherein the agent is cytostatic.   75. The device of claim 72, wherein the drug is rapamycin.   68. The device of claim 67, wherein the agent is cytotoxic.   75. The device of claim 74, wherein the medicament is paclitaxel.   58. The instrument of claim 57, further comprising at least one securing mechanism provided on the at least one helix.   77. The instrument of claim 76, wherein the at least one securing mechanism comprises at least one barb.   58. The device of claim 57, further comprising a spinal member.   58. The device of claim 57, wherein the pores vary in size from one end of the at least one helix to the other end of the at least one helix.   80. The device of claim 79, wherein the pores vary in size from a large size at the one end of the at least one helix to a small size at the other end of the at least one helix.   80. The instrument of claim 79, wherein the pitch of the at least one helix varies in size from one end of the at least one helix to the other end of the at least one helix.   82. The instrument of claim 81, wherein the pitch of the at least one helix varies in size from a large size at the one end of the at least one helix to a small size at the other end of the at least one helix.   58. The instrument of claim 57, wherein the pitch of the at least one helix varies in size from one end of the at least one helix to the other end of the at least one helix.   84. The instrument of claim 83, wherein the pitch of the at least one helix varies in size from a large size at the one end of the at least one helix to a small size at the other end of the at least one helix. A device for capturing emboli in blood vessels,
Having a plurality of mesh panels that can move from a crushed state to an expanded state when placed in a blood vessel;
When the mesh panel is in an expanded state, the mesh panel forms a double spiral structure and forms a plurality of turns arranged in a spiral around the longitudinal axis;
The mesh panel is provided with a plurality of pores,
The instrument has a pore size of 120 μm or more.   The instrument of claim 85, wherein the mesh panel comprises a self-expanding material.   90. The device of claim 86, wherein the self-expanding material comprises a shape memory material.   90. The device of claim 87, wherein the shape memory material comprises a metal alloy.   90. The device of claim 88, wherein the metal alloy comprises a nickel titanium alloy.   88. The instrument of claim 85, wherein the mesh material comprises stainless steel.   90. The device of claim 86, wherein the self-expanding material comprises a polymer.   92. The device of claim 91, wherein the polymer is biodegradable.   94. The device of claim 92, wherein the polymer is bioabsorbable.   94. The device of claim 93 further comprising a medicament.   92. The device of claim 91, further comprising a drug.   95. The device of claim 94, wherein the agent is cytostatic.   99. The device of claim 96, wherein the agent is rapamycin.   95. The device of claim 94, wherein the agent is cytotoxic.   99. The device of claim 98, wherein the medicament is paclitaxel.   96. The device of claim 95, wherein the agent is cytostatic.   101. The device of claim 100, wherein the drug is rapamycin.   96. The device of claim 95, wherein the agent is cytotoxic.   105. The device of claim 102, wherein the agent is paclitaxel.   86. The instrument of claim 85, further comprising at least one securing mechanism provided in the double helix structure.   105. The instrument of claim 104, wherein the at least one securing mechanism comprises at least one barb.   86. The device of claim 85, further comprising a spinal member.   86. The device of claim 85, wherein the pores vary in size from one end of the at least one helix to the other end of the at least one helix.   108. The device of claim 107, wherein the pores vary in size from a large size at the one end of the at least one helix to a small size at the other end of the at least one helix.   108. The instrument of claim 107, wherein the pitch of the at least one helix varies in size from one end of the at least one helix to the other end of the at least one helix.   110. The instrument of claim 109, wherein the pitch of the at least one helix varies in size from a large size at the one end of the at least one helix to a small size at the other end of the at least one helix.   86. The instrument of claim 85, wherein the pitch of the at least one helix varies in size from one end of the at least one helix to the other end of the at least one helix.   112. The instrument of claim 111, wherein the pitch of the at least one helix varies in size from a large size at the one end of the at least one helix to a small size at the other end of the at least one helix. A method of capturing an embolus in a blood vessel in a patient's body,
Having at least one helix made of mesh material, the at least one helix having a plurality of turns arranged helically around a longitudinal axis, the mesh material having a plurality of pores Providing an instrument, wherein the pore size is 120 μm or more;
Placing the device in a blood vessel in a patient's body.

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