endovascular filter-valve device to reduce the flow of an embolizing agent into a blood vessel durin

专利摘要:
MICRO VALVE PROTECTION DEVICE AND METHOD OF USE FOR PROTECTION AGAINST THE REFLUX OF EMBOLIZATION AGENTS. The present invention relates to an apparatus which is provided, which is useful in an embolization procedure and which allows substantially unrestricted blood to flow forward into a blood vessel and reduces or stops the reflux (regurgitation or regressive flow) of agents embolization that are introduced into the blood. A method for using the device is also provided.
公开号:BR112012013375B1
申请号:R112012013375-6
申请日:2010-12-02
公开日:2020-06-30
发明作者:James E. Chomas；Leonard Pinchuk；John Martin；Aravind Arepally；Brett E. Naglreiter；Norman R. Weldon；Bryan M. Pinchuk
申请人:Surefire Medical, Inc.；
IPC主号:

专利说明:

[0001] [0001] The present invention relates, in general, to an embolic medical treatment system. More particularly, the present invention relates to an embolizing treatment system that uses a protective device that reduces the reflux of a treatment agent into a blood vessel during an embolization therapy procedure, where the embolization agent is released via a catheter to deliver therapy to distal tissue through a catheter release port. State of the art
[0002] [0002] Embolization, chemoembolization and radioembolization therapy are often used clinically to treat a variety of diseases, such as hypervascular liver tumors, uterine fibroids, secondary liver cancer metastasis, preoperative treatment of menangiomas hypervascular vessels in the brain and bronchial artery embolization for hemoptysis. An embolizing agent can be realized in different ways, such as spheres, liquid, foam, or glue positioned in the arterial vasculature. The spheres can be uncoated or coated. Where the spheres are coated, the coating can be a chemotherapy agent, a radiation agent or another therapeutic agent. When it is desirable to embolize a small blood vessel, small capsule sizes (for example, 10 pm to 100 pm) are used. When a larger blood vessel is to be embolized, a larger sphere size (for example, 100 μm to 900 μm) is typically chosen.
[0003] [0003] Although embolizing agent therapies are considered minimally invasive or limited, they have often provided good results, they have a small incidence of non-specific embolization that can lead to adverse effects and morbidity. A cause of non-specific release of embolizing agents is reflux in the artery. Reflux occurs where the embolic agent exits the distal end of the catheter and then recedes around the outside of the catheter. This counterflow can end up in a healthy organ and harm it.
[0004] [0004] Reflux can also occur during administration of the embolization agent, although the artery is still free. Reflux can also occur when the artery becomes static and the injected embolizing agents flow back.
[0005] [0005] Additionally, reflux can be a time-sensitive phenomenon. Sometimes, reflux occurs as a response to an injection of the embolic agent, where reflux occurs quickly (for example, on the millisecond time scale) in a way that is too fast for a human operator to respond. In addition, reflux can happen momentarily, followed by a temporary resumption of forward flow in the blood vessel, only to be followed by additional reflux.
[0006] [0006] Figure 1 shows a conventional embolization treatment (prior art) in liver therapy 106. Catheter 101 releases embolization agents (spheres) 102 in a hepatic artery 106, with the aim of embolizing a target organ 103. It is important that the forward flow (direction of the sixth 107) of blood is maintained during an infusion of the embolization agents 102, as the forward flow is used to transport the embolization agents 102 deep into the vascular bed of the target organ 103.
[0007] [0007] Embolization agents 102 are injected continuously until reflux of the contrast agent is visualized in the distal area of the hepatic artery. In general, since embolization agents 102 can rarely be viewed directly, a contrast agent can be added to embolization agents 102. The addition of the contrast agent allows visualization of the reflux of the contrast agent (shown by Friday 108 ), which is indicative of the reflux of the embolization agents 102. Reflux can undesirably cause the embolization agents 102 to be released in a collateral artery 105, which is proximal to the tip of the catheter 101. The presence of embolization agents 102 in the collateral artery 105 leads to an untargeted embolization in an untargeted organ 104, which may be another lobe of the liver, stomach, small intestine, pancreas, gallbladder, or other organ.
[0008] [0008] Undirected release of the embolic agent can have significant unwanted effects on the human body. For example, in the treatment of the liver, the untargeted release of the embolic agent can have unwanted impacts on other organs, including the stomach and small intestine. In the treatment of uterine fibroma, undirected delivery of the embolic agent can embolize one or both ovaries that lead to loss of the menstrual cycle, subtle ovarian damage that can reduce fertility, early menopause and, in some cases, damage substantial for the ovaries. Other unintended adverse events include deep unilateral buttock pain, buttock necrosis, and uterine necrosis.
[0009] [0009] Radiologists often try to reduce the amount and impact of reflux by slowly releasing the embolic agent and / or by presenting a reduced dosage. The added time, complexity, increased x-ray doses for the patient and doctor (more time to monitor the patient) and potential for reduced efficacy make the slow release of embolization agents optimal. In addition, reducing the dosage often leads to the need for multiple treatments with follow-up. Even when the doctor tries to reduce the amount of reflux, the local flow conditions at the tip of the catheter change too fast to be controlled by the doctor, and therefore, momentary rapid reflux conditions can happen throughout the infusion. Summary of the Invention
[0010] [00010] According to one aspect of the invention, an implantable device is provided that is useful in an embolization procedure and that allows substantially unrestricted flow of blood into a blood vessel and reduces or stops reflux (regurgitation) or regressive flow) of embolization agents that are introduced into the blood.
[0011] [00011] In some embodiments, the device that can be implanted includes a delivery catheter that has a valve fixedly attached to its distal end. An external catheter is provided, which extends through the valve during introduction to keep the valve in a collapsing cylindrical configuration until the valve is advanced through the patient to the desired vascular destination. Once at the destination, the external catheter is retracted from the valve to allow expansion of the valve in an open state, as discussed below.
[0012] [00012] In other embodiments, the device that can be implanted includes a release catheter and a valve introducer that releases a valve to a valve seat at the distal end of the release catheter during the embolization procedure. No external catheter is required. A valve introducer keeps the distal end of the valve in a closed configuration, and a push wire is contiguous against the proximal end of the valve and is used to propel the valve out of the valve introducer and through the release catheter. The valve is advanced by the thrust wire to the valve seat located at the distal end of a delivery catheter. Once the valve seat captures a proximal part of the valve to lock the valve at the distal end of the release catheter, the push wire is then extracted from the release catheter to provide a device with a marked fluid flow through the release catheter. In certain embodiments, a pusher member is attached to the valve to release the lock between the valve and the valve seat and to allow the valve to retract into the delivery catheter after the embolic agent has been dispensed.
[0013] [00013] The valve that can be implanted includes a plurality of filaments that cross each other (that is, in weft) and that have a spring actuation to assume an angle of crossing in relation to each other. In the first state, the valve is preferably maintained in a cylindrical arrangement with a diameter substantially equal to the diameter of the delivery catheter. In a second state, the valve is free to open due to the spring acting on the filaments. In the second state, with the proximal end of the valve attached to the release catheter, in the bloodstream, if blood is not flowing distally beyond the valve, the valve takes on a substantially frusto-tapered shape. The distal end of the valve is intended to make contact with the walls of the blood vessel into which it is implanted when blood is not flowing distally beyond the valve.
[0014] [00014] In some embodiments, the valve, while allowing forward substantially unrestricted flow into a blood vessel and which reduces or stops the reflux of embolization agents, allows for reflux of blood and contrast agent. In other embodiments, the valve, while allowing substantially unrestricted forward flow into a blood vessel and reducing or stopping the reflux of embolizing agents, also reduces or blocks the flow of blood.
[0015] [00015] According to one aspect of the invention, the valve has a radial expansion force when in the unimplanted state less than 40 mN.
[0016] [00016] According to another aspect of the invention, the valve has an expansion time constant from the cylindrical arrangement to the fully open position where in a static fluid that at a viscosity of approximately 3.2cP from between 1.0 and 0 , 01 seconds, and more preferably between 0.50 and 0.05 seconds.
[0017] [00017] According to a further aspect of the invention, the valve has a Young modulus of elasticity that is greater than 100 MPa.
[0018] [00018] In accordance with yet another aspect of the invention, the preferred crossing angle of the valve filaments is approximately 130 degrees.
[0019] [00019] In accordance with yet another aspect of the invention, the valve filaments are selected to have a desired number and diameter, such that in an open position, they are able to capture the embolizing agents. By way of example only, the valve filaments are selected so that in an open position, they have a pore size of 500μm and thus are able to prevent reflux of the embolizing agent, such as spheres that are larger than 500μm. As another example, the valve filaments are selected due to the fact that in an open position they have a pore size of 250μm and thus are able to prevent reflux of the embolizing agent that is larger than 250μm.
[0020] [00020] In one embodiment, the valve filaments are coated with a filter that is formed and attached to the filaments in any of the desired ways, such as by spraying, spinning, electrospinning, bonding to an adhesive, thermal melting, bonding cast, or other method. The filter is preferably arranged to have a desired pore size, although it is noted that the pore size may be non-uniform, depending on the technique in which the filter is loaded and fixed. As an example, the pore size of the filter can be approximately 40 µm, such that embolizing agents that have a characteristic size of more than 40 µm are prevented from refluxing beyond the valve. As another example, the pore size of the filter can be approximately 20 µm, such that embolizing agents that have a characteristic size of more than 20 µm are prevented from refluxing beyond the valve. In both cases, blood cells (which have a characteristic size less than 20 μm), and the contrast agent which has a molecular size less than 20 μm will pass through the filter and the valve.
[0021] [00021] According to a further aspect of the invention, when in a fully open position where the filaments assume the preferred transverse angle, the valve is adapted to have a distal diameter that is at least twice the diameter of the delivery catheter, and preferably at least five times the diameter of the delivery catheter.
[0022] [00022] In one embodiment, the filaments are all formed from a polymer. In another embodiment, one or more of the filaments is formed from stainless steel, platinum or platinum iridium.
[0023] [00023] In an embodiment where one or more filaments are formed from a polymer, the filaments that are formed from the polymer are preferably fused at their proximal end in the delivery catheter.
[0024] [00024] The valve can be implanted in any of several ways. Thus, just as an example, in suitable modalities, an external catheter or sleeve extending through the release catheter can be used to keep the valve in an unimplanted state, and the external catheter or sleeve can be extracted back in relation to the release catheter in order to implant the valve. Where the external catheter or sleeve is used, the valve can be captured and returned to its non-implanted position by moving the release catheter proximally to the external catheter or the sleeves.
[0025] [00025] As another example, the distal end of the valve can be provided with loops that are adapted to engage a guidewire that extends through and distal to the distal end of the release catheter and through the distal loops of the valve. When the guidewire is extracted proximally, the valve is implanted.
[0026] [00026] As another example, a mesh sleeve with a control cable can be provided to cover the valve. The control cable, when pulled, causes the mesh sleeve to be unstitched, thus releasing the valve.
[0027] [00027] As yet another example, when no external catheter is provided, the valve can be implanted by advancing through the release catheter and engaging between a valve seat at the distal end of the release catheter and the corresponding mating structure at proximal end of the valve. When the valve is engaged in the valve seat, the valve filaments extend distally from the release catheter and without further restricting the dynamic operation of the valve.
[0028] [00028] In addition, the valve can be retracted in any way. Where an external catheter is provided, the external catheter and the release catheter can be movable relative to each other to cause the external catheter to collapse with the valve. In some embodiment where no external catheter is provided, the valve can be released from the distal end of the release and withdraw catheter, or so that it is either extracted entirely from the release catheter or completely extracted from the proximal end of the release catheter. One or more traction wires, which include a weft construct, can be attached to the valve to assist with such valve extraction. It is noted that the valve can be removed from the patient in an implanted state, if necessary. Brief Description of Drawings
[0029] [00029] Figure 1 of the prior art shows a conventional embolizing catheter in a hepatic artery with the embolizing agent that has reflux in an undirected organ; figures 2A to 2C are schematic diagrams of a first exemplary embodiment of a device of the invention respectively in an unimplanted state, an partially implanted open state with blood passing in the distal direction, and a fully implanted open state where blood flow is static; figures 3A and 3B are schematic diagrams of an exemplary embodiment of a valve that has a weft component that is covered by a filter component, respectively, in an unimplanted and an implanted state; figures 4A to 4C are schematic diagrams of the exemplary embodiment of a valve of figures 3A and 3B covered by a braided mesh, respectively, in an unimplanted state, a partially implanted state and a fully implanted state; figures 5A to 5B are schematic diagrams showing the exemplary modality of a valve that can be implanted by the movement of a guidewire; figures 6A to 6D show two exemplary methods of attaching the valve mesh component to a catheter; and figures 7A to 7B show an exemplary embodiment of a valve composed of a single format memory filament and a filter; figures 8A to 8D show a modality of an exemplary structure and method for attaching a valve to the release catheter, with figures 8B and 8D being schematic cross sections through line 8B-8B in figure 8A and line 8D-8D in figure 8C, respectively; figure 8E is a schematic view of an introducer surrounding a valve and a thrust wire for the introduction into the infusion port of a delivery catheter according to the embodiment shown in figures 8A to 8D; figures 9A to 9D show another exemplary structure and method for attaching a valve to the release catheter, with figures 9B and 9D being cross sections through line 8B-8B in figure 9A and line 9D-9D in figure 9C , respectively; figures 10A to 13B show the additional exemplary structures and methods for attaching a valve to the release catheter, with figures A 'and' B 'corresponding to the valve which is located in a pre-set position and a post-position adjusted, respectively, in relation to a valve seat of the release catheter; figures 14A-17B show the modalities with the example structure for the release of the release catheter valve so that the valve can be extracted in the release catheter, with figures 'A' and 'B' corresponding to the longitudinal section and cross-sectional views, respectively; figures 18A and 18B show another exemplary structure and method for attaching a valve to the delivery catheter; figure 19 is a schematic view of the distal end of another embodiment of an apparatus for releasing a valve at the distal end of a delivery catheter; figure 20 is a schematic view of the valve of figure 19; figures 21A to 21C are distal end views of the respective modalities which employ the different valve structure for the valve of figure 20; figures 22 to 23 illustrate the apparatus of figure 19 in the implanted configurations; figures 24 to 26 are schematic views of another apparatus for implanting a sleeve valve, with figure 24 showing the valve in a housed configuration and figures 25 and 26 showing the valve in two different implanted configurations; figures 27 to 39 are schematic views of an apparatus for implanting a valve using a balloon, with figure 27 showing the valve in a closed configuration and figures 28 and 39 showing the valve in two different implanted configurations; figures 30 to 32 are a schematic view of another apparatus for implanting a filter using a balloon; figure 33 is a schematic view of another apparatus for implanting a valve; figures 34 to 36 are schematic views of another device for implanting a valve, with figures 34 showing the valve in a housed configuration, figures 35 showing the implanted valve, and figure 36 showing the valve in use ; figures 37 to 40 are schematic views of another modality of an apparatus for implanting a valve, with figure 37 showing an initial closed configuration, figures 38 and 39 illustrating the implanted configurations, and figure 40 illustrating a configuration closed assumed again; figures 41 to 43 show various discharge valves that can be used in conjunction with any of the other embodiments of the invention; figures 44 to 47 are schematic illustrations of another modality of an apparatus for implanting a valve; Figures 48 to 51 are schematic illustrations of another embodiment of a device for implanting a valve. Detailed Description of Preferred Arrangements
[0030] [00030] A first exemplary embodiment of the invention is seen in figures 2A to 2C. It is observed that figures 2A to 2C are not shown in relative size, but on the contrary, they are shown for the purpose of explanation. In figures 2A to 2C, a release catheter 201 that has a proximal end (not shown) and a distal end 205 is shown positioned within an artery 204. The release catheter 201 is adapted to release an embolizing agent from the side outside the patient's body (not shown) to a target blood vessel (artery or vein) in the patient. Attached to the distal end 205 of catheter 201 is an exemplary embodiment of a valve 203 shown that has multiple filaments 203a, 203b, 203c, ... which are preferably weft and can move relative to each other. As discussed later in this document, the filaments are spring-loaded (that is, they have "shape memory") to assume a desired transverse angle with respect to each other, so that the valve can take on a substantially frusto-tapered shape (it is noted that for the purposes here, the term "substantially frusto-conical" should be understood to include not only a truncated cone, but a truncated hyperboloid, a truncated paraboloid, and any other formation that begins from a circular proximal end and diverges from that). Around catheter 201 is an external catheter or sleeve 202 which can be moved by release catheter 201 and valve 203. If desired, the external catheter or sleeve 202 can extend the entire length of the release catheter. Where the external catheter or sleeve 202 extends along the entire length of the release catheter, it has a proximal end (not shown) that extends proximally and can be controlled by a professional from the outside of the patient's body. Alternatively, the external catheter or sleeve 202 extends only over the distal end of the release catheter 201 and valve 203, but is controlled by a control element that extends proximally and can be controlled by a professional from the outside of the patient's body.
[0031] [00031] As seen in figure 2A, when the external catheter or sleeve 202 extends through valve 203, the multiple filaments are forced into a cylindrical shape. Thus, figure 2A shows the weft valve in a non-implanted cylindrical or retracted state, with weft filaments 203a, 203b, 203c ... attached to a distal end of a catheter 205 and covered by the sleeve 202. The catheter 201 is positioned inside an artery 204 that has blood flow ahead in the direction of arrows 220 (for example, as experienced during systole with the catheter held still within the artery and blood moving against the valve in the proximal to distal direction, that is, blood that flows distally). As seen in figure 2B, by retracting sleeve 202 in the direction of arrow 210, the non-constricted valve part 203 is released to expand radially (and retract longitudinally) towards its shape memory position. However, the blood that flows distally (indicated by arrows 220) that generate a force, for example, equal to or greater than 80 to 120 mmHg, prevents the valve from opening more fully, and prevents the valve from touching the walls of blood vessel 204. As a result, valve 203 is kept in a condition where it is not opened sufficiently to block blood flow in the distal or proximal directions. In other words, the blood flow ahead causes the web to lengthen and simultaneously decrease its diameter (in relation to the fully open position) to allow fluid to pass between the web and the blood vessel wall.
[0032] [00032] Figure 2C shows valve 203 where the blood stream is a slow flow ahead 221, a static flow or a reverse flow 222 that can occur after the release of embolic agents through catheter 201 and beyond valve 203 (as if occurs, by way of example and not as a limitation, with the valve kept stationary longitudinally in the blood vessel during diastole and with blood moving against the valve in the proximal to distal direction) or static flow (with substantially equal pressure on opposite sides of the valve, as occurs when there is no significant blood movement either in the proximal or distal direction (ie, approximately U mmHg) or in flow reading ahead (with only slightly greater pressure on the distal side of the valve than the side proximal to the valve (eg 0 to 80 mmHg). In the slow flow ahead 221, the force applied by the blood against the filaments of the latched valve is not sufficient to prevent the 203 valve from opening and to reach the blood vessel wall 204. In the static flow, the blood does not apply any forward force against the valve. During reverse flow 222, the blood applies a force that helps the valve to fully open. In the fully deployed arrangement of figure 2C, the weft valve acts as a filter to block embolic agents from flowing close to the valve. However, as discussed in more detail later in this document, depending on the pore size of weft valve 203, blood and contrast agent can be allowed to flow back through the valve and around catheter 201 at the same time. that stop or significantly reduce the flow of embolic agents.
[0033] [00033] It should be noted by those skilled in the art that catheter 201 can be any catheter known in the art. Typically, the catheter will be between two to eight feet long, has an outside diameter of between 0.67 mm and 3 mm (corresponding to French 2 to French 9 catheter sizes), and will be produced from a liner produced from from fluorinated polymer, such as polytetrafluoro ethylene (PTFE) or fluorinated propylene elylene (FEP), a weft produced from metal such as stainless steel or titanium, or a polymer, such as polyethylene terephthalate (PET) or liquid crystal polymer, and an outer coating produced from an amide block polyether thermoplastic elastomeric resin, such as PEBAX (R), polyurethane, polyamide, polyamide copolymers, polyester, polyester copolymers, fluorinated polymers such as PTFE, FEP, polyimides, polycarbonate or any other suitable material, or any other standard or special material used in the manufacture of catheters used in the bloodstream. The outer sleeve or catheter 202 comprises a material capable of holding the valve web 203 in a cylindrical configuration and capable of sliding through the valve web 203 and the catheter 201. The outer sleeve or catheter 202 may consist of polyurethane, polyamide, copolymers of polyamide, polyester, polyester copolymers, fluorinated polymers such as PTFE, FEP, polyimides, polycarbonate or any other suitable material. The sleeve or external catheter may also contain a weft composed of metal, such as stainless steel or titanium, or a polymer, such as PET or liquid crystal polymer, or any other suitable material. The wall thickness of the sleeve or external catheter 202 is preferably in the range of 0.05 mm to 0.25 mm with a most preferred thickness of 0.1 mm to 0.15 mm.
[0034] [00034] The 203 valve is composed of one, two, or more metals (for example, stainless steel or Nitinol) or polymer filaments, which form a substantially frusto-conical shape when not subjected to external forces. Where polymeric filaments are used, the filaments can be composed of PET, polyethylene napphalate (PEN), liquid crystal polymer, fluorinated polymers, nylon, polyamide or any other suitable polymer. If desired, when polymeric filaments are used, one or more metal filaments can be used in conjunction with the polymeric filaments. According to one aspect of the invention, where a metal filament is used, it can be made of a radio-opaque material, such that it can be traced on the body. The valve is capable of expanding in diameter while reducing in length, and reducing in diameter while expanding in length. The valve is preferably composed of a shaped memory material that is formed and defined in a large diameter orientation. As previously mentioned, the valve is preferably maintained in a small diameter orientation until it is released and when released by removing the sleeve or other restricting component 202, the distal end of the valve expands to a larger diameter. Where the valve comprises multiple filaments, it is preferred that the filaments are not connected to each other along their lengths or at their distal ends, in order to allow the valve to open and close automatically in response to flow conditions dynamic.
[0035] [00035] In the preferred embodiment, the valve is constricted only at its proximal end where it is coupled to the catheter body, although the rest of the valve can be either constricted (retracted) by a sleeve or by a catheter, or partially not constricted (partially implanted state) or completely unconstrained (completely implanted state). When in partially or completely unconstrained conditions, depending on the flow conditions in the blood vessel, the valve may reach the walls of the blood vessel or not.
[0036] [00036] As previously mentioned, the valve diameter should change automatically in response to local flow conditions in order to allow flow ahead, but capture the embolic agents in short or prolonged periods of reverse flow. For the sake of simplicity, the valve can be considered to exist in two conditions. In a "closed" condition, the valve is not sealed against the blood vessel wall and blood can flow around at least one proximal to distal direction. In an "open" condition, the valve expands against the blood vessel wall and blood must pass through the valve if it does not flow past the valve into the blood vessel in both directions; in the "open" condition, the embolic agent is prevented from passing downstream (or in a proximal to distal direction) of the valve.
[0037] [00037] Three parameters help to define the performance and the new nature of the valve: the radial force (outward) of the valve, the time constant by which the valve changes the conditioning from closed to open, and the pore size of the valve .
[0038] [00038] In a preferred embodiment, the valve expands fully to the blood vessel wall (that is, it reaches an open condition) when any part of the flow around the web is close to permanence and remains in the closed condition when the blood is flowing distally with regular force in the distal direction. More particularly, when the radial force of expansion of the valve is greater than the force of the blood flow ahead, the valve expands to the wall of the blood vessel. However, according to one aspect of the invention, the radial force of expansion of the valve is chosen to be slow (as described in more detail below) so that blood flow in the distal direction will prevent the valve from reaching the open condition. This low expansion force is different from the expansion forces of prior art stents, stent grafts, distal protective filters and other vascular devices, which have a sufficiently high radial force to fully expand into the blood vessel wall. all flow conditions.
[0039] [00039] The radial force of expansion of a weave is described by Jedwab and Clerc (Journal of Applied Biomaterials, Volume 4, 77 to 85, 1993) and later updated by DeBeule (DeBeule et al, Computer Methods in Biomechanics and Biomedical Engineering , 2005) as:
[0040] [00040] In one embodiment, with an arrangement of valves as shown in figures 2A-2C, valve 203 is composed of twenty-four filaments of polyethylene terephthalate (PET) 203 a, 203b, ..., each having a diameter of 0.1 mm and pre-formed for a mandrel with a diameter of 8 mm and a weft angle of 130 ° (that is, the filaments are spring-loaded or have a shape memory to assume an angle of 130 ° um relative to the other when the valve assumes a fully implanted state and opens in a frusto-conical configuration). The filaments preferably have a Young modulus greater than 200 MPa, and the valve preferably has a radial force of less than 40 mN in the fully implanted position (that is, where the filaments assume their shape memory). More preferably, the valve has a radial force in the fully deployed position of less than 20mN, and even more preferably, the valve has a radial force of approximately 10mN (where the term "approximately" for use in the present invention is defined to mean + -20%) in the implanted position. Where the valve includes a filter, as well as the weft filaments (as will be discussed later in this document with respect to figures 3A and 3B), the weft component preferably has a radial force of less than 20mN in the fully deployed position, and more preferably, a radial force of less than 10mN, and even more preferably, a radial force of approximately 5mN. This compares prior art embolic capture devices, such as ANGIOGUARD (R) (a registered trademark of Cordis Corporation), and prior art Nitinol stents and stent grafts that typically have radial forces of between 40 mN and 100 mN in their fully implanted positions.
[0041] [00041] In accordance with one aspect of the invention, the valve opens and closes quickly enough to achieve high efficiency in capturing embolic agents in the presence of a rapidly changing direction of flow. In one embodiment, the valve moves from a fully closed (not implanted) position to a fully open position in a static fluid (eg, glycerin) that has a viscosity approximately equal to the viscosity of the blood (ie, approximately 3 , 2 cP) in 0.067 seconds. For the purposes here, the time it takes to move from the fully closed position to the fully open position in a static flow is called a "time constant". According to another aspect of the invention, the valve is arranged such that the time constant of the valve in a fluid that has a blood viscosity is between 0.01 second and 1.00 second. Most preferably, the valve is arranged such that the time constant of the valve in a fluid that has a blood viscosity is between 0.05 and 0.50 seconds. The valve time constant can be adjusted by changing one or more of the parameters described above (for example, the number of filaments, the modulus of the filament elasticity, the diameter of the filaments, etc.).
[0042] [00042] As will be seen by those skilled in the art, the weft geometry and material properties are closely related to the radial force and the time constant of the valve. Since, according to one aspect of the invention, the valve is useful in a variety of arteries of different diameters and flow conditions, each implantation can be exclusively optimized. Just as an example, in one embodiment, the valve has ten filaments, while in another embodiment, the valve has forty filaments. Preferably, the filament diameter is chosen in the range of 0.00 25 mm to 0.127 mm although other diameters can be used. Preferably, a gap angle (that is, the crossing angle assumed by the filaments in their fully open position, the shape memory position) is chosen in the range of 100 ° to 150 °, although other gap angles can be used . Preferably, the Young modulus of the filament is at least 100 MPa, and more preferably at least 200 MPa. In accordance with another aspect of the invention, the valve is chosen to have a pore size that is small enough to capture the embolic agents (filter) in the bloodstream as blood passes through the valve. Where large embolic agents (eg 500μm) are used, it may be possible for the valve filaments to act directly as a filter to prevent embolic agents from passing through the valve (provided the filaments present in the smaller pores, for example, 500μm ). Alternatively, a filter can be added to the filament structure. Such a separate filter is particularly useful where minor emolic agents are used.
[0043] [00043] Figure 3A shows a weft valve 203 at the distal end of a catheter 201 and which has a filter 301 which is added to the weft structure 203. The filter can be positioned in the weft by spraying, wiring, electrospinning , bonding with an adhesive, thermally melting, mechanically capturing the web, bonding by melting or any other desired method. The filter can either be a material with pores, such as ePTFE, a solid material that has pores added, such as polyurethane with laser-drilled holes, or the filter can be a very thin filament blanket that is positioned in the weft. Where filter 301 is a thin filament blanket, the characteristic pore size of the filter can be determined by attempting to pass the balls of different diameters through the filter and find which balls of diameter are capable of passing through the filter in large quantities. Very thin filaments can rotate in a rotating mandrel according to U.S. patent 4,738,740 with the help of an electrostatic field or in the absence of an electrostatic field or both. The filter formed in this way can be adhered to the weft structure with an adhesive or the weft can be positioned on the mandrel and the filter can rotate on it, or under it, or both, on or under the weft to capture it in an essential way. The filter can have the same pores formed from spraying or electrospinning and then a secondary step where the pores are laser drilled or formed by a secondary operation. In the preferred embodiment, a material capable of being deposited or rotated electrostatically is used to form a filter in the web, with the preferred material being able to bond to itself. The filter can be produced from polyurethane, polyethylene, polyolefin, polyester, fluoropolymers, acrylic polymers, acrylates, polycarbonates, or other suitable material. The polymer is spun in the web in a wet state and therefore it is desirable that the polymer be soluble in a solvent. In the preferred embodiment, the filter is formed from polyurethane which is soluble in dimethylacetamide. The polymeric material is spun in the web in a liquid state, with a preferred concentration of 5 to 10% solids for an electrostatic spinning process and 15 to 25% solids for a wet spinning process. Figure 3B shows the valve in the implanted state, with external catheter 202 retracted proximally (as indicated by the arrow) where weft 203 and filter 31 <)> 1 are expanded.
[0044] [00044] According to one aspect of the invention, filter 301 has a characteristic pore size between [auction] [Omicron] [mu] [eta] [iota] and 500 [mu] [eta] [iota]. Most preferably, the 301 filter has a characteristic pore size between 15 [mu] [eta] [iota] and [auction] [Omicron] [Omicron] [mu] [eta] [iota]. Even more preferably, the 301 filter has a characteristic pore size of less than 40μm and, more preferably, between 20 μm and 40μm. More desirably, the filter 301 is provided with a characteristic pore size that will allow blood and the contrast agent to pass through it, while blocking the passage of the embolizing agent through it. By allowing blood and the regurgitated contrast agent to pass through the filter, in a direction from the distal valve to the proximal end of the valve, the contrast agent can be used to indicate when the target site is fully embolized and can serve to identify a clinical endpoint of the embolization procedure. Therefore, according to one aspect of the invention, the valve allows reflux of the contrast agent as an indicator of the clinical endpoint while preventing reflux of the embolization agents at the same time. In addition, by allowing blood to flow back through the material filter, even at a relatively slow rate, the counterweight on the distal side of the valve can be reduced. However, it is noted that the filter does not need to be constructed to allow either the blood or the contrast agent to pass through in the direction of "reflux".
[0045] [00045] According to one aspect of the method of the invention, the valve is capable of endovascular implementation. The valve is preferably coupled to the distal end of a catheter. When the distal end of the catheter is in the correct location for treatment, the valve is implanted. Preferably, with the valve implanted, the embolization agents are released distally through the catheter into the blood vessel. The release of embolization agents will tend to result in sluggishness or paralysis of blood flow in the distal direction and an expansion resulting from the valve from an initial diameter, which is less than or equal to the outside diameter of the catheter (that is, its lodged position or not implanted) to a final diameter (its open position) which is preferably at least twice, and more typically four to ten times the outside diameter of the catheter. In its open position, the valve prevents embolization agents from moving beyond the valve (between the catheter wall and the blood vessel wall) in a proximal direction. According to one aspect of the invention, the valve is preferably capable of being retracted to its closed position after the embolization treatment procedure is completed.
[0046] [00046] It is important to note that the valve is a dynamic element that opens and closes based on local flow conditions. Under normal flow conditions, the flow pressure is sufficient to overcome the weak actuation force, thus forcing the valve to the contact position, such that it is not in contact with the vascular wall. In static or reverse flow, the actuation force of the valve filaments causes the valve to be in an open position where it is preferably in full contact with the vascular wall, thus restricting the reflux of the embolizing agents, even in which preferably allows the reflux of blood and contrast agents. It is not necessary for blood and contrast agent to be allowed to return through the valve, however, blood reflux prevents back pressure on the distal side of the valve and reflux of the contrast agent helps in visualizing blood flow.
[0047] [00047] According to one aspect of the invention, the implantation of the valve is controlled from the proximal end of the catheter. In some embodiments, a control wire or a set of two or more control wires extending from the proximal end of the catheter to the distal end of the catheter can be used and controlled by the practitioner to implant and optionally retract the valve . In some embodiments, a control cable that extends from the proximal end of the catheter to the distal end of the catheter is used to sew the tissue covering the valve in order to implant the valve. In some embodiments, an external catheter that extends the length of the catheter to which the valve is attached, covers the valve and is pulled back during implantation to allow the valve to expand. In some embodiments, an outer sleeve that is attached to a control element that extends the length of the catheter, covers the valve and during implantation is pulled back by the control element to allow the valve to expand. In some embodiments, the valve is attached to a guidewire, and removal of the guidewire catheter initiates implantation of the valve. Control wires, cables, sleeves, etc. can be in the standard length range, from 60 cm to 240 cm in length.
[0048] [00048] As previously mentioned, valve implantation can be achieved in a variety of ways. As described in figure 2, the valve can be implanted by moving an external catheter or sleeve that covers the valve. In that modality, the valve can be captured again by the external catheter or by the sleeve by moving the catheter or sleeve distally or the release catheter and the valve proximally. In another embodiment, and as seen in figures 4A to 4C, the valve is released by irreversibly removing (unraveling) a mesh mage (braided mesh) 402 that covers valve 203 (shown with filter 301). More particularly, as seen in Figure 4A, valve 203 is attached to the distal end of catheter 201. At the top of the valve is a braided mesh sleeve 402. A control cable 401 is attached to the braided mesh and extends to the end proximal to the catheter. In one embodiment, the mesh that can be misaligned is made of polyester with a thickness between μm and 60 μm, the mesh can be a textile wrap that is kept under tension. Figure 4B shows the implantation of the valve by attracting control cable 401. In one embodiment, cable 401 is connected to the distal end of the mesh sleeve 402 and releases the valve first by removing material from the distal end of the sleeve 402 As control cable 401 is pulled back and the sleeve is reduced in size, the distal end of valve 203 that has filter 301 is free to open. The braided mesh sleeve 402 can be partially or fully removed to allow the clinician to control the diameter or length of the valve. In figure 4C, the braided mesh is removed more completely allowing more of the length of valve 203 and filter 301 to be free. In another embodiment, the cable is attached to the median or proximal end of the sleeve, and releases the valve first by removing material from the proximal end or middle of the sleeve.
[0049] [00049] Now, with reference to figures 5A and 5B, in another embodiment, a guidewire 501 can be used to implant the valve 503. More particularly, the valve 503 is provided with loops 502, which are fixed in or near the distal end of the filaments of valve 503. Loops 502 can be integral with the filaments or can be produced from a separate material and fixed to the filaments. As seen in figure 5A, loops 502 are wrapped around the distal end of guide wire 501 that extends through the lumen of catheter 201. Loops on valve end 502 are wrapped around guide wire 501 while catheter 201 and the 501 guide wire is advanced through the vasculature. In this way, the distal end of the valve is kept in a closed position. When the guidewire 501 is extracted proximally as indicated by the arrow in figure 5B, distal loops 502 are released, and valve 503 is implanted.
[0050] [00050] According to one aspect of the invention, the valve of any embodiment of the invention is attached to the distal end of the catheter in several ways. As seen in figure 6A, valve 203 is attached to catheter 201 by a sleeve 601 that overlaps the proximal end of valve 203 and is understood to be proximal to the proximal end of valve 203 by catheter 201. Figure 6B shows a cross-sectional view of catheter 201, valve 203 and sleeve 601. Sleeve 601 is mechanically connected or maintained by a heat shrinking process or other mechanical process to catheter 201 and thus maintains the distal end of valve 203 in catheter 201 by means of capturing the distal end of the valve between catheter 201 and sleeve 601.
[0051] [00051] In a preferred embodiment, the valve is fused in the catheter. More particularly, as seen in figure 6C, valve 203 fused to catheter 201, such that in the region 602 where the valve and catheter are fused, there is at most a minimal change to the internal or external diameter of catheter 201. Figure 6D shows a cross-sectional view of the cast valve, where catheter 201, valve 203 and cast region 602 all have the same diameter. The fusion of the catheter and the valve can be achieved by thermally fusing the valve, fusing the catheter, fusing both the valve and the catheter, or through a chemical process.
[0052] [00052] Now, with reference to figures 7A d 7B, a valve 702 composed of a single filament coil is seen. The coil can be produced from metal or polymer and, preferably, the filament has a memory format polymer. Figure 7A shows a coil valve 701 in the retracted state on a 201 catheter. The coil valve is provided with a filter 702 at its distal end. Figure 7B shows the coil valve in the implanted state, where valve 701 and filter 702 are expanded at the distal end. Any of a variety of methods, as shown above, can be used in implanting the valve.
[0053] [00053] Now, with reference to figures 8A to 8E, another embodiment of an implantation device 800 is shown. The implantation apparatus 800 includes a delivery catheter 801, a valve 803, an implantation element 810 and a valve introducer 812. In contrast to certain previous embodiments, the delivery catheter is not required to be advanced in relation to an external catheter or external sleeve to implant the valve, as will be evident from the description below.
[0054] [00054] The delivery catheter 801 is preferably 3 French microcatheters or 4 or 5 French catheters. The 801 delivery catheter is constructed of one, two or more than two layers. In one embodiment, the release catheter 801 includes an inner liner produced from, for example, FEP or PTFE, a central web produced from one or more between metal, polymer or liquid crystal polymer, and an external polymeric cover produced from, for example, a thermoplastic elastomeric polyether block amide resin, such as PEBAX (R), polyether ether ketone (PEEK), or other suitable polymer.
[0055] [00055] The release catheter 801 has a distal end 805 provided with a valve seat 814 and a radio-opaque marker strip 816 located proximal to, distal to, or around valve seat 814. Valve seat 814 is preferably defined by a circumferential internal groove located at the distal end 805 of the release catheter 801. Valve seat 814 can be defined directly on the release catheter, or can be attached or fused to the release catheter or to the distal end 805 release catheter. When valve seat 814 is defined directly on release catheter 801 and the release catheter is produced from a multilayer construct, valve seat 814 can be defined through one or two layers, or two layers and a partial depth of a third outer layer.
[0056] [00056] The 803 valve is, in general, as described in any of the above modalities. The valve 803 can be a polymer web coated with a polymer surface, a metal web coated with a polymer surface, or a combination of polymer and metal web coated with a polymer surface. The polymer surface can be a blade, a blade with holes drilled in it or a mesh. The valve can be permeable or impermeable to blood. Regardless of the construct, the valve is a dynamic element that opens and closes based on the conditions of blood flow. The proximal part of valve 803 includes mating structure 818 which can engage with valve seat 812 at distal end 805 of release catheter 801 when the valve is advanced through the release catheter, as described in more detail below.
[0057] [00057] The mating structure 818 may include a shaped memory polymer or an elastic polymer that can be compressed for advancement through the catheter body, but which will automatically expand to fit on the valve seat 814. Referring to figures 8C and 8D, when mating structure 818 is engaged with valve seat 814, such engagement locks valve 803 with respect to release catheter 801 to prevent further distal movement of the valve from the release catheter and to prevent the valve from exiting the distal end of the release catheter during the procedure. The mating structure 818 can comprise a plurality of independent features, for example, four features, each of which separately engages the valve seat. In addition, the characteristics must be small with respect to the profile, for example, which does not exceed 0.25 mm in a dimension of radial "height" 818h through a center of characteristics, in order to be discreet inside the release catheter 801 to the as valve 803 is advanced through the release catheter and also after the valve is engaged with valve seat 814. As an example, the mating structure on valve 803 includes a plurality of radio-metal pellets opaque 818a-d connected, cast, furrowed or otherwise attached to valve 803 and which can be received in valve seat 814. Valve seat 814 may additionally include a radio-opaque marker. In this way, the alignment of the valve to the valve seat can be visualized by fluoroscopy. Pellets 818a-d have proximal and distal surfaces 819a, 819b which are formed to prevent the advancement or withdrawal of valve 803 once the pellets are received in the valve seat. That is, surfaces 819a, 819b can extend in planes perpendicular to the longitudinal axis of the delivery catheter. The proximal portion of valve 803 is preferably constricted by the inner wall 801a of the release catheter 801 in order to define an internal diameter 803 through the valve.
[0058] [00058] The implanting element 810 is a driving wire, preferably in general, similar in construction to a conventional guide wire. The outer diameter of the distal end 810a of the push wire is greater than the inner diameter of the proximal end of the 803 valve. As a result, the push wire 810 can be used to provide a pulling force on the proximal part 803a of the 803 valve and advance the valve through the release catheter 801; that is, the distal end 810a of the push wire 810 and the proximal part 803a of the valve is relatively dimensioned so that the push wire 810 will not extend freely through valve 803. When the proximal part 803a is constricted by inner wall 801a, the push wire 810 may include a polymer microsphere or metal microsphere to increase its distal end diameter and to facilitate the application of traction force to the valve. Additionally or alternatively, a cylindrical or tubular member can be cast or bonded at the distal end of the push wire to assist in applying a pulling force against the valve. Additionally or alternatively, one or more coils of metal or polymer may be provided at the distal end of the drive wire to increase its outside diameter. Any feature added to the distal end of the push wire must maintain the tracking ability of the push wire. The drive wire 810 is preferably produced from a radio-opaque material or contains one or more radio-opaque markers, such as platinum, along its length.
[0059] [00059] The valve introducer 812 is a polymeric tube made, for example, of PTFE. The introducer 812 is preferably 1 cm to 50 cm in length and can optionally be provided with a cable at its proximal end (not shown) to facilitate its manipulation. As shown in figure 8E, valve 803 and, preferably, at least a part of the push wire are held within introducer 812 with the distal end of valve 803 maintained in a collapsed configuration. The introducer 812, by retaining valve 803 in the collapsed configuration, presents the valve in a size suitable for advancement through the release catheter 801. Introducer 812 has a large internal diameter sufficiently to contain the collapsing valve 803 and the push wire 810. The introducer 812 has an outside diameter smaller than the inside diameter of the infusion port 807 at the proximal end of the delivery catheter, so that the introducer can be advanced into the infusion port. In one embodiment, the inside diameter is 0.89 mm and the outside diameter is 0.96 mm.
[0060] [00060] With reference to figures 8C and 8D, when using the 800 device, a standard guidewire (not shown) is advanced through the patient's vasculature towards a desired treatment site. The 801 delivery catheter is advanced through the standard guidewire to the desired location. Once the 801 delivery catheter is in the desired location, the standard guidewire is removed from the delivery catheter and the patient. The valve introducer 812 is then inserted into the infusion port of release catheter 801. Depending on the length of the introducer valve 812, it can act as a guide for valve insertion only at the proximal end of the release catheter or as a guide along a substantial length of the delivery catheter. The thrust wire 810 is then advanced distally from the introducer 812 to propel valve 803 (in an unimplanted configuration) into release catheter 801 towards valve seat 814. When valve 803 approaches valve seat 814, mating structure 818 automatically expands inwardly and engages valve seat 814 to lock valve 803 in relation to distal end 805 of release catheter 801. In the locked configuration, the valve is implanted at the distal end of the release catheter. The push wire 810 is then extracted from the release catheter 801.
[0061] [00061] The embolic agents are then infused through the release catheter 801 and the valve 803. The valve 803 works as described above. That is, as embolic agents are infused, valve 803 allows forward flow, but prevents the reverse flow (reflux) of embolic agents into the blood vessel into which the delivery catheter is inserted. As a result of not using a tube inside a tube construct during the infusion of embolic agents (ie, a delivery catheter with an external sleeve), as described in several embodiments above, a larger delivery catheter can be used to provide a greater flow of embolic agents to the treatment site. After completion of the infusion, the delivery catheter 801, together with valve 803 at its distal end 805, is removed from the patient.
[0062] [00062] It should be noted that although positive enlargement between a valve and the valve seat is desired, it is not necessary. That is, the supplied alignment of the valve in relation to the distal end of the catheter can be visualized by means of a fluoroscope, as with the use of respective radio-opaque markers, the valve can be manually held in the appropriate location in relation to the catheter.
[0063] [00063] Another modality similar to the implantation device 800 includes an implantation element constructed by a thin wire attached to the valve. The term wire, preferably, a diameter from 0.0025 mm to 0.125 mm, and can be a standard wire or a flat wire. A flat wire may correspond more closely to the internal surface of the catheter to limit any obstruction of the catheter lumen. In use, the thin wire advances the valve to the valve seat and then remains attached to the valve and into the catheter during the infusion of the embolic agent.
[0064] [00064] Now, with reference to figures 9A to 9D, another embodiment of an implantation device 900 is shown. The implantation device 900 is substantially similar to the device 800 and includes a release catheter 901, a valve 903, a push wire 910 and a valve introducer (as described with respect to the introducer 812). The difference between apparatus 900 and apparatus 800 described above is the mating structure 918 provided for the valve to lock the valve in relation to the valve seat. In figures 9A and 9B, mating structure 918 is a proximal ring-shaped flange that is compacted radially or otherwise deformed to a size that allows advancement through the release catheter as it is driven by push wire 910. As shown in figures 9C and 9D, once push wire 910 releases valve 903 to the distal end 905 of release catheter 901, flange 918 expands on valve seat 914 once located in valve seat for locking valve 903 in relation to valve seat 914. Ring-shaped flange 918 can be defined by an elastic element coupled to the valve web or a metal web or metal part of the valve that does not have a expansion force much greater than the rest of the valve.
[0065] [00065] Figures 10A to 12B illustrate the additional modalities of a mating structure flange that can be used on the valve to lock the engagement between a valve and a valve seat. Figures 10A and 10B show a flange 1018 that has a proximal end that in the cross section appears reformed or J-shaped that engages inside the valve seat 1014. Figures 11A and 11B show a flange 1118 that has a front surface in contiguity 1118a and a posterior chamfer 1118b (which appears as a barb in the cross section) so that the flange has a proximal taper (that is, a smaller proximal diameter and a relatively larger distal diameter). This structure facilitates the proximal release of the flange 11 18 of the valve seat 1014 for the removal of the valve 1 103 from the release catheter 1101, which is particularly suitable in conjunction with an embodiment of the apparatus provided with a valve retraction element, discussed below. Figures 12A and 12B show a flange 1218 comprising an O-ring and, where the valve seat 1214 is in the form of a circular channel in which the O-ring is captured. Figures 13A and 13B illustrate another embodiment of a valve seat 1314 at the distal end of release catheter 1301 and the corresponding mating structure 1318 on a valve 1303. Valve seat 1314 and mating structures 1318 are "keyed" with multiple longitudinally displaced structures that accentuate the engagement between valve 1303 and valve seat 1314, but which can prevent locking engagement until the structures are in proper longitudinal alignment with each other. As an example shown, the valve seat can include a plurality of longitudinally displaced channels 1314a, 1314b, wherein a distal channel 1314a is wider than a proximal channel 1314b. The mating structure 1318 includes a distal flange 1318a sized to be received in the distal channel 1314a, but too large to be received in the proximal channel 1314b. The mating structure also includes a proximal flange 1318b which is adequately sized to be received and captured by the proximal channel 1314b. When the proximal and distal flanges 1318a, 1318b are aligned with the proximal and distal channels 1314a, 1314b, the flanges expand in the respective channels and lock the valve 1303 in relation to the distal end of the release catheter 1301. In any case of the embodiments described above, the flange may include an uninterrupted element in a circumferential manner or may comprise the separate elements radially displaced around the proximal part of the valve. In addition, although the valve seat is shown to comprise the "negative" space and the mating structure as one or more expanding elements in such a space, it should be noted that the structure for the valve seat and the structure mating can be reverse; that is, such that the valve seat comprises the elements that extend into the lumen of the release catheter and the mating structure being a groove or other negative space around the proximal end of the valve. However, such a reverse configuration is less desirable as it reduces the diameter of the infusion path at the distal end of the delivery catheter.
[0066] [00066] Now, with reference to figures 14A and 14B, another embodiment of the implantation device 1400 is shown. The implantation apparatus 1400, which includes elements similar to the apparatus 800, has a release catheter 1401, a valve 1403, a push wire 1410 and a valve introducer (as described with respect to the introducer 812). In addition, apparatus 1400 includes a retraction element 1420 which is attached to the proximal part of valve 1403 and, more preferably, to the mating structure 1418 thereof, to apply a release and retraction force to the valve to thereby disengage the valve from the valve seat and extract the valve through the release catheter.
[0067] [00067] The retraction element 1420 is a tension wire fixed to the mating structure 1418. The tension wire 1420 can be flattened or otherwise formed, such that it conforms close to the inner surface 1401a of the release catheter 1401 for maximize unused space within the lumen of the delivery catheter for the release of the embolic agent. The traction wire 1420 must have sufficient mechanical strength with respect to tension to release and extract valve 1403 from the release catheter. However, it should be noted that the draw wire 1420 is not required to have a compression stiffness as the draw wire 1410 extends parallel to the draw wire 1420 and performs the function of advancing the valve to the distal end of the release catheter.
[0068] [00068] The use of the device is similar to the device 800. The valve 1403, the thrust wire 1410 and the pull wire 1420 are all surrounded by an introducer (not shown) that facilitates the introduction of such elements in the infusion port of the release catheter. Push wire 1410 advances valve 1403 and pull wire 1420 out of the introducer and into the distal end of release catheter 1401. Once valve 1403 engages valve seat 1414, push wire 1410 is pulled out release catheter 1401. Embolic agents are then infused through the release catheter 1401 to treat the patient. After the embolic agents have been infused, valve 1403 can be extracted into release catheter 1401 by applying sufficient traction force to the traction wire 1420 to release valve 1403 from valve seat 1414 and retract it into the catheter. release 1401. The release catheter is then removed from the patient. Optionally, the traction wire 1420 can be used to completely extract valve 1403 from release catheter 1401 before removing the release catheter from the patient.
[0069] [00069] In addition to a single traction wire, the retraction element can take other forms that can be used in a similar way to extract the valve from the release catheter after infusion of the embolic agent. For example, with reference to figures 15A and 15B, the retracting element includes a plurality of pulling strands, such as the pulling strand pair 1520a, 1520b shown. In addition, with reference to figures 16A and 16B, the retraction member may comprise a tubular retraction web 1620 of multiple metal wires or polymeric filaments. The 1620 weft can be produced from stainless steel, Elgiloy (R), Nitinol or other elastic material. The tubular web 1620 can have a predefined diameter that is equal to or greater than the diameter of the lumen of the delivery catheter. In this way, the retraction web can be held tight against the push force of the push wire 1610 in order to decrease it to a diameter less than the diameter of the lumen of the release catheter 1601. Once the push wire 1610 advances valve 1603 to valve seat 1614, tension is released from web 1620 to allow the web to be held out against the inner wall 1601a of release catheter 1601. Additionally, with reference to figures 17A and 17B, a web retraction 1720 may be coated with a polymeric coating 1722. The polymeric coating 1722 may include, for example, one or more of polyurethane, polyamide, polyimide, PTFE or FEP, such that the retraction element defines a catheter body. It is observed that in the modalities, with the use of a retraction element separated from a push wire, the retraction element can be developed with a low resistance to compression, as the 1710 push wire advances both the valve and the retraction element through the release catheter.
[0070] [00070] As yet another alternative, the push wire and the retraction element may comprise a single element that has sufficient compressive and tension forces to advance the valve to the valve seat and retract the valve from the valve seat at the end of the procedure. Such a unique element must be of a design that retains the space that cannot be used within the lumen of the release catheter to allow sufficient infusion of embolic agents.
[0071] [00071] Referring to figure 18A, another 1800 implantation device is shown. The 1800 implantation device has a 1801 delivery catheter, a 1803 valve, an 1810 push wire, a retraction element in the form of an 1820 polymer-coated lock and a valve introducer (as described with respect to the 812 introducer) . Valve seat 1814 is defined by the distal end of release catheter 1801. The mating structure 1818 of valve seat 1814 is compacted for advancement through the release catheter. As shown in figure 18B, once the mating structure 1818 passes through the distal end 1805 of the release catheter 1801, the mating structure expands and is in contact with the valve seat 1814. The retracting element 1820 maintains the pulling force on valve 1803 to hold valve 1803 against valve seat 1814.
[0072] [00072] In another embodiment of the invention, no implantation element is required. The valve is advanced through the catheter to a valve seat using hydraulic pressure. Any of the valve designs described above with respect to figures 8 to 17 are provided inside the catheter, for example, using an introducer. Then, through the infusion port, a bolus of saline or heparin saline is injected into the catheter through the valve to force the valve to the distal end. U.S. Patent No. 6,306,074, which is incorporated herein by reference, describes the use of hydraulic pressure to advance treatment elements, such as radioactive therapeutic seeds through a catheter, to an application site. Hydraulic pressure can similarly be applied to advance the valve, considering the frictional forces between the valve and the internal surface of the catheter, blood pressure and gravitational force. It should be noted that when the valve is inside the catheter, it collapses radially sufficiently to provide an adequate barrier within the catheter on which the solution bolus acts.
[0073] [00073] Another embodiment of a 1900 delivery device is shown in figure 19. The 1900 delivery device includes an external catheter 1901 that has a proximal end (not shown) and a distal end 1903, an internal catheter 1904 that can be extended through the external catheter, and a valve 1905 located at the distal end 1903 of the external catheter 1901. The valve 1905 includes a proximal structure that can be expanded 1906, one or more control members 1908 (or 1908a, 1908b in figure 20) coupled to the proximal end of frame 1906, a central collar 1910 at the distal end of frame 1906, and one or more flaps of valve 1912 that extend distally from collar 1910. Frame 1906 and collar 1910 are preferably produced from a structure that can be expanded. Both the 1906 frame and the 1910 collar are preferably produced from a material that has the shape memory or other spring-like expandable properties, so that they are self-expanding or are constructed from a non-shape or material memory non-flexible that can be expanded by force, for example, by balloon expansion, as further described below. Structure 1906 when collar 1910 may be a mesh of metal wire or polymeric filaments, a wire or tubular structure, or other suitable structure. Structure 1906 when collar 1910 can be integrally formed together, or formed separately and then coupled together. The 1910 collar can be expanded sufficiently and sized appropriately to be in contact with the internal wall of an artery when partially or fully expanded. The flaps of the 1912 valve are preferably constructed in a similar manner to the valve structures described above. For example, the flaps of valve 1912 may each comprise a fibrous structure or other mesh superimposed on a polymer coating. The valve flaps can be structured to allow blood and / or contrast agent to pass through their material, or they can be impermeable to such fluids. The flaps of valve 1912 may include two flaps 1912 of equal size in a platypus formation (figure 21A), three or more flaps 1912 'of equal size (figure 21B), or flaps 1912a ", 1912b" of different size (figure 21C). In each embodiment, the distal parts of the flaps can be formed (as shown by the dotted lines) to define a circular opening 1913 for the passage of the internal catheter 1904 through them. The control member 1908 can advance and retract the valve 1905 in relation to the external and internal catheter 1901, 1904 between the housed and implanted configurations. Alternatively, the valve 1905 can be directly coupled to the internal catheter 1904, with the movement of the internal catheter in relation to the external catheter 1901 which performs the movement of the valve 1905 between the housed configuration and an implanted configuration. In a first housed configuration, frame 1906 and collar 1910 are constricted radially by external catheter 1901, and flaps 1912 are held together against each other (before insertion of internal catheter 1904 through the valve) (figures 21A to 21C). In a second housed configuration shown in figure 19, frame 1906, collar 1910 and valve 1905 remain radially constricted inside external catheter 1901 and internal catheter 1904 is extended through the flaps of valve 1912. In a first implanted configuration, the Operation of control member 1908 distances valve 1905 distally from the distal end of external catheter 1901, and collar 1910 is allowed to self-expand until the proximal ends of valve flaps 1912 are adjacent to arterial wall 1920 (figure 22) . Alternatively, where valve 1905 is coupled to internal catheter 1904, the internal catheter functions as the control member and the internal catheter and external catheter are moved relative to each other to advance the valve out of the distal end external catheter in the same implanted configuration. In the first implanted configuration, valve 1905 is forced to open in the forward flow of blood 1922a through the arterial passage. The embolizing agent 1924 is infused through the internal catheter 1904 and the forward blood flow prevents 1922a advances from the embolic agent 1924 with the artery1920. When the blood flow changes to a retrograde, static or slow 1922b flow, the valve changes dynamically due to pressure flow conditions for a second implanted configuration in which the distal end of the 1912 valve flaps close against the internal catheter 1904 (figure 23). This prevents any embolizing agent from passing back beyond the valve.
[0074] [00074] Now, with reference to figure 24, another modality of a release device 2000, substantially similar to the release device 1900, is equipped with a valve 2005. The valve 2005 includes a proximal structure that can be expanded 2006, optionally a or more control members 2008a, 2008b coupled to the proximal end of the 2006 structure, a central collar 2010 at the distal end of the 2006 structure and a 2012 tubular valve sleeve. The 2012 sleeve is preferably constructed in a manner similar to any valve described above, for example, with a fibrous polymer-coated construct, but may be of another construction. In a housed configuration, the 2012 sleeve resides between the external catheter 2001 and the internal catheter 2004 of the release device 2000, with the internal catheter 2004 extending through the sleeve. Sleeve 2012 can be advanced in relation to the external catheter 2001 in a configuration implanted by assembling it in relation to the internal catheter 2004 and which advances the internal catheter in relation to the external catheter or, alternatively, through the operation of the control member 2008a, 2008b to move the sleeve in relation to both the external catheter 2001 and the internal catheter 2004. Regardless of how the 2010 valve collar 2010 is released from the external catheter, once released, the 2010 collar expands to be in contact with the arterial wall 2020 and implant the valve 2012. Blood can flow between the valve and the internal catheter (figure 25). In a second implanted configuration, which results when blood flow 2012b is slow, static or retrograde, the valve sleeve 2012 closes against the internal catheter 2004 (figure 26).
[0075] [00075] Now, with reference to figure 27, another embodiment of a 2100 release device is shown. The release apparatus 2100 includes a valve 2105 coupled to a catheter 2101. The valve 2105 includes a plurality of supports 2116 coupled at its proximal ends by a collar 2117. A suitable filter material 21 18 extends between the supports 21 16. The release device 2100 also includes a protector 2126 attached to catheter 2101 that shields the arterial wall 2120 from the distal ends of the supports 21 16 when valve 2105 is in an unimplanted configuration. The release device 2100 includes a control member in the form of a balloon 2124 which, when expanded, applies a radial force to the supports that flex sufficiently to release the valve from protector 2126. This results in valve 2105 which comes into contact an deployed configuration. The balloon 2124 can be expanded using a specialized lumen of the internal catheter 2104, a separate inflation catheter or through any other suitable system (such as the one described below with respect to figures 30 to 32). In the implanted configuration, forward blood flow is allowed around the outside of the valve (figure 28). However, in static flow (2122b), slow flow or reverse flow, valve 2105 responds dynamically or quickly to changing flow conditions and opens fully to the arterial wall 2120 preventing the flow of embolizing agent beyond the valve (figure 29).
[0076] [00076] Now, with reference to figures 30 to 32, another modality of a release device [Zeta] [Zeta] [upsilon] [upsilon] is shown. A catheter 2201 includes an external control member balloon 2234. A valve 2205 is provided by balloon 2234 and includes filter material 2212 that extends through the circumferentially displaced supports 2216. The balloon is positioned centrally radially between the supports. The balloon 2224 includes a pressure valve 2235 in communication with the lumen 2228 of the catheter 2201. A guide wire 2240 with an occlusive tip 2242 is advanced through the lumen 2228 of the catheter 2201. The occlusive tip 2242 is advanced beyond the pressure 2235 (figure 31). An injectable 2234, such as saline, is then injected into the lumen catheter 2228. With reference to figure 32, sufficient fluid and pressure are provided to cause the injectable to enter pressure valve 2235 and fill the balloon 2234. The 2234 balloon fills up to high pressure and then seals to prevent leakage under low pressure conditions. As the 2234 balloon is filled to a high pressure state, it is in contact with valve 2205 to move the valve to an implanted configuration. The 2240 guidewire can then be extracted from catheter 2201. The valve is then used as described above in conjunction with the infusion of an embolizing agent through catheter 2201. After completion of the procedure, catheter 2201 can be taken back to an external catheter (not shown) and such that contact between valve 2205 and the distal end of the external catheter will bypass pressure valve 2235 and cause the pressure valve to release balloon 2234 to deflate and the valve again assumes an unimplanted configuration for patient removal.
[0077] [00077] Now, with reference to figure 33, another embodiment of a 2300 release device is shown. The apparatus includes an external catheter 2301, an internal catheter 2304 that extends through the external catheter, and valve 2305 which comprises an expandable wire structure 2306 coupled to the internal catheter 2304 or which can be operated through the control members independent 2308, an expandable collar 2310 coupled to the structure, a first tapered sleeve part 2311 extending from the collar, and a second sleeve part 2312 extending from the first sleeve part. In a housed configuration (not shown), the internal catheter 2304, the structure 2306, the control members 2308, the collar 2310 and the sleeve parts 2311, 2312 are held within the external catheter 2301 and advanced to the site of interest within of the 2320 artery. In an implanted configuration, the internal catheter 2304 is advanced out of the distal end of the external catheter 2301 and the control members 2308 are operated from the proximal end of the device to implant the structure 2306, the collar 2310 and the sleeves 231 1, 2312 outside the external catheter 2301 and over the internal catheter 2304. The collar 2310 expands the proximal end of the first tapered sleeve 2311 adjacent to the arterial wall 2320. During blood flow ahead 2322a, blood flows between the internal catheter 2304 and the sleeves 231 1, 2312, similar to the air flowing through a windsock. However, at least the second sleeve 2312 is structured to collapse in response to reverse blood flow conditions 2322b, so that the embolizing agent is in contact with the outside of the sleeves 2311, 2312, but cannot pass.
[0078] [00078] Now, with reference to figures 34 to 36, another embodiment of a 2400 release device is shown. The release device 2400 includes a control member 2408 with a self-expanding loop (or collar) 2410 at its distal end. A valve 2412 is understood from loop 2410. Valve 2412 has an open distal end 2413. Control member 2408 is operated to advance valve 2412 to the distal end 2403 of an external catheter 2401 which is advanced to arterial location of interest. With reference to figure 35, the control member 2408 is then operated to advance the loop and the valve out of the distal end 2403 of the external catheter 2401, with the loop expanding automatically causing the proximal end valve 2412 is positioned against or adjacent to arterial wall 2420. Then, as shown in figure 36, an internal catheter 2404 is advanced through external catheter 2401 and completely through the open distal end 2413 of filter valve 2412. The embolizing agent 2424 is infused through the internal catheter 2404. Blood can blow in the forward direction between the internal catheter 2404 and the filter valve 2412. During retrograde blood flow, loop 2410 retains its diameter against arterial wall 2420, but distal and central parts of the filter valve 2412 dynamically collapse against the internal catheter 2404 in response to the change in blood pressure that prevents the reservoir flow d the embolic agent 2424 in addition to the valve.
[0079] [00079] Now with reference to figure 37, another embodiment of a 2500 release device is shown. The delivery device 2500 includes a catheter 2501, a first collar 2530 around the catheter 2501 and coupled to the catheter or a first control member 2532, a second collar 2534 displaced from the first 2530 and located around the catheter and coupled to a second control member 2536, a plurality of supports 2516 extending between the first and second collar 2530, 2534 and a valve sleeve 2512 extending over at least part of the supports 2516 and preferably the second collar 2534. With reference to figure 38, in operation, when the second control member 2536 is retracted in relation to the catheter 2501 and / or the first control member 2532 (that is, whichever first collar 2530 is attached), the supports 2516 are blown forward, thus moving the proximal end of the valve sleeve 2512 against the arterial wall 2520. Embolizing agent 2524 can be injected through catheter 2512. Blood advancing forward 2522a can fl flow between valve sleeve 2512 and catheter 2501. Referring to figure 39, when blood changes the direction of flow 2522b, the rapid change in pressure in valve sleeve 2512 causes the valve sleeve to react dynamically with its distal end that collapses against catheter 2501 to prevent retrograde flow of embolizing agent 2524. Release device 2500 can collapse for extraction by moving the first control member 2532 proximally to the second control member 2536 to adjust the supports 2516 and thus reduce the diameter of the valve sleeve 2512 (figure 40).
[0080] [00080] It should be noted that any of the modalities described above may be desirable to wash the external catheter in a controlled way through a route that comes out behind the valve. Such washing may include a contrast agent, saline, etc. Now, with reference to figure 41, an embodiment of a discharge valve includes one or more open slits 2640 in the external catheter 2601. A side lock 2642 is provided in the annular space between the external and internal catheter 2601, 2604.
[0081] [00081] Alternatively, block 2642 can be provided against an external catheter 2601 in which no internal catheter is provided. Side lock 2642 is coupled to the distal end of a control member 2644. In a closed state, the proximal end of the control member 2644 is manipulated to position side lock 2642 in obstruction of open slits 2640 to prevent fluid from passing through the same. To allow washing, the proximal end of the control member 2644 is manipulated to position the lateral lock 2642 or proximal or distal (shown) in relation to the opening slits 2640 so that the fluid can be discharged through them. Now, with reference to figure 42, another embodiment of a washing system is shown that incorporates the 2740 slit valves in the external catheter 2701. Such 2740 slit valves are normally in a closed configuration. However, by applying a pressure wash, the 2740 slit valves are opened and the wash is allowed to escape the catheter (figure 43).
[0082] [00082] Now, with reference to figure 44, another embodiment of a 2800 valve implantation device is shown. Apparatus 2800 includes two longitudinally displaced catheters 2801, 2802 and a dynamic valve 2805 located between them. More particularly, the first closest microcatheter 2801 is a high flow microcatheter that preferably has an internal diameter of 0.69 mm and an external diameter of 0.97 mm and includes a proximal luer 2803 or other suitable connector in its proximal end 2801a and has a distal end 2801b. The second distal microcatheter 2802 preferably has a proximal end 2802a with a proximal face 2802c, an inner diameter less than 0.53 mm, and the same outer diameter of 0.97 mm as the microcatheter. The valve 2805 preferably comprises a web which is fused at its proximal end 2805a to the distal end 2801b of the first microcatheter 2801 and at its distal end 2805b to the proximal end 2802b of the second microcatheter 2802. The web is naturally actuated to self-expand in an radial from an unimplanted state to an implanted state, where the valve in the non-implanted state (described below) has a diameter approximately equal to the outer diameter of the first and second microcatheters, and in the implanted states it has a substantially larger diameter . The web includes a proximal part 2805c which is coated with polymer as described with respect to the various valves described above, while a distal part 2805d of the web is uncoated and forms an opening design that allows fluid to flow through it.
[0083] [00083] The apparatus 2800 additionally includes an elongated thin-walled tubular member 2850 which preferably has an internal diameter of 0.53 mm and an external diameter of 0.64 mm. The tubular member 2850 is most preferably in the form of a coil of thread 2852, preferably with a peripheral thread that extends axially 2854 or lining 2856 for longitudinal stability. The tubular coil member has a proximal end 2850a provided with a hub 2858 to lock in relation to the luer connector 2803, such as the Tuohy Borst adapter and a distal end 2850b. When the tubular coil member 2850 is inserted into the luer connector 2803, through the first microcatheter 2801, and through the valve 2805, its distal end 2850b is in contiguity with the proximal face 2802c of the second microcatheter 2802. The tubular coil member 2850 it is dimensioned such that when fully advanced in the first microcatheter 2801, the proximal end 2802a of the second microcatheter 2802 is displaced from the distal end 2801b of the first microcatheter 2802 by a sufficient distance to apply a pulling force on the valve to cause the valve lengthen and retract in diameter to a significantly smaller non-implanted diameter suitable for advancement through the blood vessel. The 2800 device can be presented in this configuration as a manufactured and / or sterilized package.
[0084] [00084] With reference to figure 45, a standard 0.356 mm guide wire 2860 is provided for use with the 2800 device. The 2860 guide wire is inserted through hub 2858 and luer connector 2803 and through the first microcatheter 2801, valve 2805 and second microcatheter 2802. Guide wire 2860 is advanced to the plunger location and apparatus 2800 is then traced by the guide wire to the location.
[0085] [00085] With reference to figure 46, the guide wire 2860 is shown extracted, and the tubular coil member 2850 is released from the luer connector 2803 and removed from the first microcatheter 2801, allowing valve 2805 to expand into the arterial wall ( not shown). The embolizing agent 2824 is then infused through the first microcatheter 2801 and exits through the uncoated distal part 2805d of the valve and the second microcatheter 2802. Importantly, valve 2805, although attached at its distal end to the second microcatheter, it is a dynamic valve that quickly adjusts to the flow conditions that result from the change in blood pressure in systole and diastole. Thus, during the forward flow of blood in the systole, the coated proximal part 2805c collapses to allow blood to flow around the valve, and during retrograde, static or slow blood flow in the diastole, the coated proximal part of the valve opens against the arterial wall preventing the passage of any embolizing agent.
[0086] [00086] Now, with reference to figure 47, after the procedure, the device comprising microcatheters 2801, 2802 and valve 2805 can simply be extracted from the artery, which will automatically collapse with the valve. However, as an option, the tubular coil member 2805 can be reinserted to aid in collapse and the 2860 guide wire can also optionally be inserted to facilitate reverse tracking out of the patient. Regardless of the method of removal, it is observed that any 2824 embolizing agent that remains in the valve upon collapse of the valve will remain trapped in the valve for recovery as the weft angle will be reduced in size through collapse to define the very openings. small for the embolizing agent to pass.
[0087] [00087] Now, with reference to figures 48 and 49, another embodiment of a 2900 valve implantation device, substantially similar to the 2800 implantation device, is shown. The 2900 apparatus includes two longitudinally displaced catheters 2901, 2902 and a 2905 dynamic valve located between them. More particularly, the first closest microcatheter 2901 is a high flow microcatheter that preferably has an internal diameter of 0.69 mm and an external diameter of 0.97 mm and includes a 2903 connector at its proximal end 2901a and has a distal end 2901b. The second distal microcatheter 2902 preferably has a proximal end 2902a with a proximal face 2902c, an inner diameter less than 0.53 mm, and the same outer diameter of 0.97 mm as the first microcatheter. The valve 2905 preferably comprises a web which is fused at its proximal end 2905a to the distal end 2901b of the first microcatheter 2901 and at its distal end 290b to the proximal end 2902b of the second microcatheter 2902. The web includes a proximal part 2905c which is polymer coated, as described with respect to the various valves described above, while a distal part 2905d of the web is uncoated and forms an open design that allows fluid to flow between them.
[0088] [00088] The 2900 apparatus additionally includes an elongated member, such as a 2960 guide wire. The 2960 guide wire is preferably a 0.45 mm diameter guide wire, but may have other dimensions and includes a hub 2958 adjacent to its proximal end 2960a and, preferably, a radiopaque marker strip 2962 adjacent to its distal end 2960b. Marking tape 2962 is larger than the internal diameter of the second microcatheter and is thus adapted to be contiguous against the proximal face 2902c. A fixed length is indicated, either by the actual length, indications, or blockages between the guide wire at the proximal end 2901a of the first microcatheter 2901 or the distal end of the 2962 marker tape. The guide wire is inserted through the first microcatheter, such length fixed, so that the marker tape is contiguous against the proximal face of the second microcatheter; this results in the valve entering the collapsed configuration. The device with the guidewire is then advanced to the target. Once on the target, the guidewire is removed from the device.
[0089] [00089] With reference to figure 50, the device in use is substantially similar to that described above with respect to figure 46. Valve 2905 expands into the arterial wall (not shown). The embolising agent 2924 is then infused through the first microcatheter 2901 and exits through the uncoated distal part 2905d of the valve and the second microcatheter 2902. Importantly, valve 2905, although attached at its distal end to the second microcatheter, it is a dynamic valve that quickly adjusts to the flow conditions that result from the change in blood pressure in systole and diastole. Thus, during the forward flow of blood in the systole, the coated proximal part 2905c collapses to allow blood to flow around the valve, and during retrograde, static or slow blood flow in the diastole, the coated proximal part of the valve. valve opens against the arterial wall preventing the passage of any embolizing agent.
[0090] [00090] Now, with reference to figure 51, after the procedure, the device comprising the microcatheters 2901, 2902 and the valve 2905 can be extracted simply by retracting it from the artery, which will cause the valve to collapse. However, optionally, the 2960 guide wire can be reinserted for valve 2905 to collapse. It should be noted that any embolic agent 2924 that remains in the valve upon collapse of the valve will remain trapped in the valve for recovery as the weft angle will be reduced in size through collapse to define very small openings for the embolic agent. pass.
[0091] [00091] In any of the modalities described here, the valve components can be coated to reduce friction during implantation and retraction. The components can also be coated to reduce clot formation along the valve or to be compatible with therapeutics, biologies, or embolism. The components can be coated to increase the binding of the embolizing agents so that they are removed from the blood vessel during retraction.
[0092] [00092] According to one aspect of the invention, the catheter body and mesh can be identified separately to facilitate visualization by fluoroscopy. The catheter body can be identified using any means known in the art, for example, by combining a radio-opaque material in the catheter tube. The radio-opaque material can be barium sulfate, bismuth subcarbonate or other material. Alternatively or additionally, the radio-opaque rings can be positioned or attached to the catheter, where the rings are produced from platinum, platinum iridium, gold, tantalum and the like. The valve can be identified by attaching a small radio-opaque element, such as a ring to one or a plurality of filaments. Alternatively or additionally, the radio-opaque medium can be mixed into the weft and filter materials. Or, as previously described, one or more of the filaments can be chosen to be produced from a radio-opaque material, such as platinum iridium.
[0093] [00093] In certain embodiments, the valve is attached to a catheter which can be a single lumen or multiple lumen catheter. Preferably, the catheter has at least one lumen used to deliver the embolization agents. According to other modalities, however, the catheter can be provided with a lumen that either serves to store the valve before implantation or through which the valve can be released. Where control members are used to control valve implantation, one or more additional lumens can be provided, if desired, to contain control wires for implantation and retraction. Alternatively, the catheter around which the control members extend may include the longitudinal opening channels through which the control wires can extend. An additional lumen can also be used to administer fluids, for example, for flushing the artery after administration of embolization agents, or for controlling a balloon that could be used in conjunction with the valve.
[0094] [00094] The apparatus and methods above were mainly directed to a system that allows the flow of biological fluid proximal and distal (eg blood) within a blood vessel in the body, and that prevents the reflux of an infusate beyond the valve in a proximal direction. It should be noted that the valve can also be optimized to reduce blood flow in the distal direction. The radial force of the valve can be tuned by adjusting the weft angle. The tuning of the radial force allows blood flow to be reduced by more than 50 percent. As an example, learning a weft angle greater than 130 ° will significantly reduce blood flow beyond the valve in the distal direction, with a weft angle of approximately 150 ° that decreases blood flow by 50 to 60 percent. Other frame angles can provide different reductions in distal blood flow. The distal blood flow can be used in place of a "wedge" technique, in which the distal blood flow is reduced for the treatment of the weft and spinal malformations related to an artery or vein. Once the blood flow is decreased by the valve, a glue, such as a cyanoacrylic, can be applied to the target site.
[0095] [00095] The multiple modalities of devices and method for reducing or preventing reflux of embolization agents in a blood vessel have been described and illustrated here. Although the particular embodiments of the invention have been described, it is not intended that the invention be limited to them, it is intended that the invention be broader in scope that the technique will allow and that the specification and be read in the same way. Thus, although the particular implantation means for the protection valve have been described, such as a catheter, a sleeve and control element, a fabric sleeve with a control thread, etc., it is observed that other mechanisms of implantation, such as balloons, sleeves that can be absorbed or combinations of elements could be used. In the same way, although several materials have been listed for the valve filaments, the valve filter, the catheter and the implantation media, it is observed that other materials can be used for each one. Furthermore, although the invention has been described with respect to specific human arteries, it is noted that the invention can be applied to any blood vessel and other vessels, including human and animal channels. In particular, the device can also be used for liver, renal or pancreatic carcinoma treatments. In addition, the modalities have been described with respect to their distal extremities, due to the fact that their proximal extremities can take various forms, including those well known in the art. As an example only, the proximal end may include two cables with a cable connected to the inner (delivery) catheter, and another cable connected to an external catheter or sleeve or drive wire or column. The movement of one cable in a first direction in relation to the other cable can be used to implant the valve, and where applicable, the movement of that cable in a second opposite direction can be used to recapture the valve. Depending on the cable layout, valve deployment can occur when the cables are moved away from each other and towards each other. As is well known, the cables can be arranged to exhibit linear motion in relation to each other or rotational motion. If desired, the proximal end of the internal catheter can be provided with markings or other indications at intervals along the catheter, so that the movement of the cables relative to each other can be visually calibrated and result in an indication of the point at which the valve is opened. Therefore, it is observed by those skilled in the art that yet other modifications can be made to the supplied invention without deviating from its spirit and scope as claimed.

权利要求:
Claims (18)
[0001]
Endovascular filter-valve device to reduce the flow of an embolizing agent into a blood vessel (204) during an embolization therapy procedure comprising: an elongated release catheter (201) having a proximal end and a distal end (205) defining an open tip, the release catheter (201) being able to release the embolization agent through the open tip of the distal end (205); a valve (203) having a proximal end and a distal end, the valve (203) coupled to its proximal end and to the distal end (205) of the catheter (201), so that the embolizing agent is released through the delivery catheter (201) feeds the proximal end of the valve (203), the valve (203) having a plurality of filaments (203a, 203b, 203c) in the form of a weft, the valve (203) configured and inclined to expand from a state not implanted to an implanted state; wherein once the valve (203) is in the implanted state in the blood vessel, the valve (203) is dynamically movable between an expanded open valve configuration and a collapsed closed valve configuration depending on the local biological fluid pressure over the valve ; and characterized by the fact that: the valve (203) opening from the non-implanted state to a completely open state in less than one second in a fluid at rest having a viscosity of 3.2 cP; and a filter (301) integrated with the valve (203), the filter (301) fixed to said plurality of filaments (203a, 203b, 203c), covering said filter (301) over said plurality of filaments (203a, 203b, 203c), said filter (301) having pores with a characteristic diameter of less than 500 μm; wherein when the fluid pressure is higher on a proximal side of the valve (203), the valve (203) is in the closed valve configuration allowing fluid flow over the valve; when the fluid pressure is higher on a distal side of the valve (203), the valve (203) is in the open valve configuration in which the valve makes contact with the blood vessel wall (204) and the characteristic pore diameter the filter (301) makes the filter impermeable to the embolic agent so that the valve (203) is thus adapted to reduce reflux; where integration of the filter (301) and the valve (203) causes the filter (301) and the valve (203) to move together between the open and closed valve configurations while fluid pressure conditions over the valve change.
[0002]
Device according to claim 1, characterized in that the plurality of filaments (203a, 203b, 203c) includes a plurality of crossing filaments defining a weft angle of less than 70 ° when in the non-implanted state.
[0003]
Device according to claim 2, characterized in that the weft angle is approximately 110 ° when the valve (203) is in a fully open position.
[0004]
Device according to claim 1, characterized by the fact that the valve in a completely open position has a diameter of at least twice the outside diameter of the catheter.
[0005]
Device according to claim 1, characterized by the fact that the filaments have a filament diameter between 25.4 μm (0.001 ") to 127 μm (0.005").
[0006]
Device according to claim 1, characterized by the fact that it further comprises a controllable implantation element from the proximal end of the catheter, the implantation element adapted to maintain the valve in the non-implanted state and to release the valve from the not implanted state.
[0007]
Device according to claim 6, characterized by the fact that the implantation element is an external catheter that extends around the release catheter and the valve.
[0008]
Device according to claim 1, characterized by the fact that the plurality of filaments includes a plurality of polymeric filaments that form a frusto-conical shape, when the valve is in the implanted state.
[0009]
Device according to claim 8, characterized in that the valve (203) further comprises at least one metal filament.
[0010]
Device according to claim 1, characterized in that the plurality of filaments (203a, 203b, 203c) comprises a plurality of crossing filaments, which are not connected to each other where they intersect.
[0011]
Device according to claim 1, characterized by the fact that the plurality of filaments (203a, 203b, 203c) comprises from ten to forty filaments.
[0012]
Device according to claim 1, characterized by the fact that the plurality of filaments (203a, 203b, 203c) is composed of a material chosen from polyethylene terephthalate (PET), polyethylene naphthalate (PEN), liquid crystal polymer , stainless steel, nitinol, fluorinated polymers, nylon, polyamide, platinum or platinum iridium.
[0013]
Device according to claim 1, characterized by the fact that the filter (301) is chosen from (i) a material having pores, (ii) a solid material having pores formed in it, and (iii) a blanket of material coupled to at least one filament by spraying, spinning, electrospinning, bonding with an adhesive, thermal melting, mechanically capturing the weft or melting bonding.
[0014]
Device according to claim 1, characterized by the fact that the filter (301) has pores having a characteristic size of approximately 40 μm or less.
[0015]
Device according to claim 1, characterized in that the filter (301) is composed of a material selected from a group consisting of polyurethane, polyolefin, polyester, fluorine polymers, acrylic polymers, acrylates, and polycarbonates.
[0016]
Device according to claim 1, characterized by the fact that each of the plurality of filaments (203a, 203b, 203c) has a Young's modulus of elasticity greater than 200 MPa.
[0017]
Device according to claim 1, characterized in that the valve (203) opens from the non-implanted state to a completely open state in between 0.05 and 0.50 seconds in a fluid at rest having a viscosity of 3.2 cP.
[0018]
Device according to claim 1, characterized by the fact that the proximal end of the valve (203) is attached to the distal end of the catheter.

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同族专利:

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公开号 | 公开日

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US8696698B2|2014-04-15|

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JP5806227B2|2015-11-10|

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US20120089102A1|2012-04-12|

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AU2010326055A1|2012-07-05|

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US20140207178A1|2014-07-24|

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US9295540B2|2016-03-29|

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BR112012013375A2|2016-03-01|

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EP2506800A4|2016-12-07|

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CN102665608A|2012-09-12|

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CA2782386C|2017-05-02|

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EP2506800B1|2020-01-22|

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CN102665608B|2015-11-25|

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CA2782386A1|2011-06-09|

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WO2011068924A1|2011-06-09|

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US8696699B2|2014-04-15|

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AU2010326055B2|2015-01-29|

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JP2013512735A|2013-04-18|

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US20110137399A1|2011-06-09|

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ES2784744T3|2020-09-30|

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EP2506800A1|2012-10-10|

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法律状态:
2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|

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2019-07-23| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|

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2020-01-07| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application according art. 36 industrial patent law|

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2020-05-05| B09A| Decision: intention to grant|

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2020-06-30| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 02/12/2010, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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US12/957,533|2010-12-01|

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PCT/US2010/058641|WO2011068924A1|2009-12-02|2010-12-02|Microvalve protection device and method of use for protection against embolization agent reflux|

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