embolic protection device

专利摘要:
ANGIOGRAPHY CATHETER. Embolic protection device and methods for capturing embolic debris. An embolic protection device includes a pig tail catheter having a lumen to accommodate a guidewire. The distal portion of the catheter has one or more openings in fluid communication with the lumen and one or more radiopaque markers in the most distal section. The device includes a self-expanding filter attached to one side of the catheter and a mobile outer casing surrounding the catheter. The outer shell keeps the filter in a collapsed configuration when surrounding the filter. The outer coating is retracted proximally to implant the filter. A method of capturing embolic debris includes inserting a guidewire into a body lumen, tracking the device through the guidewire, retracting the guidewire, positioning the device using the radiopaque marker, retracting the outer coating and implanting the filter, performing a procedure and advance the outer coating to recapture the filter.
公开号:BR112013017310B1
申请号:R112013017310-6
申请日:2011-12-27
公开日:2020-12-29
发明作者:William M. Merhi
申请人:Innovative Cardiovascular Solutions, Llc；
IPC主号:

专利说明:

CROSS REFERENCE TO RELATED ORDERS
[001] This application claims priority benefit from US Provisional Patent Application 61 / 460,660, filed on January 7, 2011, and claims priority from US Patent Application 13 / 311,265, filed on December 5, 2011, which claims the priority benefit of US Provisional Patent Application 61 / 460,660, all of which are incorporated herein by reference. FUNDAMENTALS Field
[002] The present application generally relates to devices and methods for locating the appropriate position to perform a cardiac procedure and / or to capture embolic debris during a cardiac procedure. Description of the Related Art
[003] During percutaneous cardiac procedures, the exact positioning of the various instruments and devices can be important. For example, when performing a percutaneous valve replacement procedure, the valve is usually placed no more than 4-6 millimeters (mm) below the lower edge of the aortic ring. Placing the valve prosthesis too low or too high can result in severe valve leakage, which in some cases can be fatal. Therefore, it may be important to identify the bottom edge of the ring to use as a landmark. A pig tail catheter can be used to inject a contrast agent to allow visualization of proper positioning. Pig tail catheters can include a curled distal portion and a plurality of small holes in the catheter side walls. The small holes allow the introduction of contrast media into the body for purposes of imaging or draining body fluids. The curled distal portion that helps maintain the catheter is placed and can decrease the flow of contrast fluids from the catheter lumen to avoid causing internal injuries or poor imaging results.
[004] A potential complication of cardiac procedures, such as valve replacement and repair, is that the calcium plaque and / or thrombus in the heart vessels, valves and / or chambers can be dislodged and cause an embolism. In fact, 2.9% -6.7% of patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) have a stroke within 30 days, and even more (4.5% -10.6%) have a stroke within a year, often leading to death. There are some devices on the market designed to protect the carotid arteries from emboli, however, these devices have several disadvantages. For example, Embrella Embolic Deflector®, available from Edwards Lifesciences of Irvine, California, diverts emboli from the carotid arteries within the descending aorta, but does not capture the emboli, so there is a risk of embolisms in other areas of the body. EMBOL-X®, also available from Edwards Lifesciences, employs a filtering screen, but is designed for use in open-heart procedures. In addition, the use of multiple devices, for example, a viewing catheter and a separate filter device, prolongs the procedure time and increases the risk of complications for the patient. SUMMARY
[005] A vascular device includes a pig tail and / or embolic protection device. A pig tail element is configured to screw on the distal end of the catheter, for example, when there is no guide wire in the catheter lumen. The pig tail element includes a radiopaque marker visible on x-rays or other radiation devices. The radiopaque marker is in the most distal section of the spiral pig's tail element in the form of a longitudinal marker, multiple bands, etc. The pig tail element may include openings for delivering drugs and / or contrast agents through the lumen. An embolic protection device includes a self-expanding filter, attached to the catheter and an outer movable coating in relation to the filter and the catheter. The outer coating keeps the filter in a collapsed configuration when surrounding the filter and is retracted proximally to implant the filter. The outer coating can recapture the filter and any captured debris can be advanced distally. The filter and the outer liner can both be movable relative to the catheter, for example, to be able to move longitudinally in the filter without having to move the entire catheter longitudinally. The combination of the pig tail element and the embolic protection device in the same vascular device can provide the benefits of both devices individually, as well as a synergistic effect. For example, expanding the filter can help anchor the pig tail element in a position to provide a more accurate positioning of the catheter than if the position of the pig tail element were influenced by blood flow, tissue movement, etc. In a valve replacement process, anchoring the pig tail element and more accurate catheter placement can, in turn, help to ensure that the prosthesis is properly positioned and stabilized. For another example, the position of the pig tail element can ensure that the filter is being positioned correctly.
[006] To use these types of devices, a guide wire is inserted through the patient's skin and into a lumen of the body, such as a femoral, radial, or brachial artery and guided near a target location. The guide wire is inserted into a lumen of the device, and the device is pushed or tracked in relation to the guide wire to the target location. When the guide wire is retracted from at least the distal portion of the catheter, the pig tail element takes on the generally arcuate shape. The radiopaque marker on the pig tail element is used to view and position the catheter. Once the catheter is in position, the outer liner is removed to implement the filter that covers the vessel. The user can then perform a procedure such as valve replacement, valve repair, radiofrequency ablation, etc. When the procedure is complete, the outer coating is advanced to recapture the filter and any debris trapped in the filter. The device is then retracted with the pig tail element being non-traumatic to the vessels during retraction.
[007] In some embodiments, an embolic protection device comprises a catheter having a proximal end and a distal end. A lumen extends from the proximal end of the catheter to the distal end of the catheter. The lumen is configured to house a guidewire. A distal portion of the catheter is configured to assume a generally arched shape that is at least a semicircle. The distal portion of the catheter includes a radiopaque marker that extends longitudinally configured to be arched in a more distal section of the catheter when the distal portion is in generally arched shape. The device also comprises a self-expanding embolic filter attached to the proximal catheter for the distal portion. The embolic filter has a generally tapered shape that extends between a distal opening and a closed proximal end. The device also includes an implantation mechanism arranged circumferentially around at least a portion of the catheter and longitudinally movable in relation to the catheter. The implantation mechanism is configured to contain the embolic filter in a collapsed configuration. The embolic filter is configured to self-expand when the implantation mechanism is longitudinally proximally retracted.
[008] In some embodiments, an angiography catheter comprises a catheter having a proximal end and a distal end. A lumen extends from the proximal end of the catheter to the distal end of the catheter and is configured to accommodate a guidewire. A distal portion of the catheter is configured to assume a generally arched shape that is at least a semicircle. The distal portion of the catheter includes a radiopaque marker that extends longitudinally, configured to be arched and in a more distal section of the catheter when the distal portion is in generally arched shape.
[009] In some embodiments, an embolic protection device comprises a catheter having a proximal end and a distal end. The device further comprises a self-expanding embolic filter attached to one side of the catheter. The embolic filter is generally conical in shape and extends between a distal opening and a closed proximal end. The device also includes an outer sheath, which is longitudinally movable with respect to the embolic filter. The outer coating is configured to contain the embolic filter in a collapsed state when the coating is at least partially around the embolic filter. The embolic filter is configured to self-expand when the outer sheath is longitudinally proximally retracted.
[0010] In some embodiments, an embolic protection device comprises a catheter having a proximal end and a distal end. A lumen extends from the proximal end of the catheter to the distal end of the catheter. The lumen is configured to house a guidewire. A distal portion of the catheter is configured to assume a generally arched shape that is at least a semicircle. The distal portion of the catheter includes a radiopaque marker that extends longitudinally, configured to be arched and in a more distal section of the catheter when the distal portion is in generally arched shape. The device further comprises a self-expanding deflector coupled to one side of the catheter and which has a longitudinal axis parallel to a longitudinal axis of the catheter. The device also includes an implantation mechanism arranged circumferentially around at least a portion of the catheter and longitudinally movable in relation to the catheter. The deployment mechanism is configured to contain the deflector in a collapsed configuration. The deflector is configured to self-expand when the implantation mechanism is moved longitudinally.
[0011] In some embodiments, an embolic protection device comprises a catheter having a proximal end and a distal end. The device comprises a deflector coupled to one side of the catheter. The deflector has a longitudinal axis parallel to a longitudinal axis of the catheter. The device also includes an outer shell, which is longitudinally movable in relation to the deflector. The outer sheath is configured to contain the baffle in a collapsed state when the sheath is at least partially around the baffle. The deflector is configured to self-expand when the outer sheath is longitudinally moved.
[0012] In some embodiments, an embolic protection device comprises a catheter having a proximal end and a distal end. The device comprises a deflector coupled to one side of the catheter. The deflector has a longitudinal axis parallel to a longitudinal axis of the catheter. The device also comprises a self-expanding embolic filter attached to the catheter. The embolic filter is generally conical in shape and extends between a distal opening and a closed proximal end. The device also includes an outer coating, which is longitudinally movable in relation to the deflector and embolic filter. The outer sheath is configured to contain the baffle and the embolic filter in a collapsed state when the sheath is at least partially around the baffle and the embolic filter. The embolic baffle and filter are configured to self-expand when the outer sheath is moved longitudinally.
[0013] In some modalities, a method of capturing embolic debris comprises inserting a distal end of an angiography catheter into a lumen of the body, tracking a lumen of the catheter along a guidewire inserted percutaneously into the body lumen . The angiography catheter has a proximal end and a distal end, and the lumen extends from the proximal end to the distal end. A distal portion of the angiography catheter includes a radiopaque marker extending longitudinally. A self-expanding embolic filter is attached to one side of the proximal to the distal portion of the catheter. The angiography catheter also includes an outer sheath that contains the embolic filter in a collapsed configuration. When the guidewire is removed from the distal portion of the catheter, the distal portion takes on a generally arcuate shape. The method also comprises the positioning of the catheter through the visualization of the radiopaque marker with an imaging technique and longitudinal retraction proximally of the outer coating, allowing the embolic filter to assume an expanded configuration, implanted having a distal opening substantially covering the lumen of the human body. .
[0014] For the purposes of summarizing the disclosure and the advantages achieved in the prior art, certain objects and advantages are described in this document. Of course, it must be understood that not necessarily all of these objects or advantages must be achieved according to any particular modality. Thus, for example, those skilled in the art will recognize that disclosure can be carried out or carried out in a way that achieves or optimizes an advantage or group of advantages as taught or suggested in this document, without necessarily achieving other objectives or advantages that can be taught. or suggested here.
[0015] All of these modalities are intended to be within the scope of the description here. These and other modalities will become readily apparent to those skilled in the art from the following detailed description with reference to the attached figures, the disclosure not being limited to any particular modality (s) disclosed. BRIEF DESCRIPTION OF THE DRAWINGS
[0016] These and other characteristics, aspects and advantages of the present disclosure are described with reference to the drawings of certain modalities, which are intended to illustrate schematically certain modalities and not to limit the invention.
[0017] FIGS. 1A and 1B show partial side views of an exemplary embodiment of an embolic protection device;
[0018] FIGS. 1C and 1D show partial side views of another exemplary embodiment of an embolic protection device;
[0019] FIG. 2A is a partial side view of an exemplary embodiment of an angiography catheter;
[0020] FIGS. 2B-2E are partial side views of other exemplary modalities of an angiography catheter;
[0021] FIGS. 3A and 3B are partial side views of an exemplary embodiment of an embolic protection device;
[0022] FIGS. 4A-4D are partial side views of another exemplary embodiment of an embolic protection device;
[0023] FIGS. 5A and 5B show partial side views of an exemplary embodiment of an alternative implantation mechanism for an embolic protection device;
[0024] FIG. 5C is an exemplary embodiment of a cross-sectional view of the implementation mechanism for the embolic protection device of FIGS. 5A and 5B along line 5C-5C in FIG. 5B;
[0025] FIG. 5D shows a partial side view of the implantation mechanism for the embolic protection device of FIGS. 5A5C;
[0026] FIG. 5E shows a partial top view of the implementation mechanism for the embolic protection device of FIGS. 5A-5D;
[0027] FIGS. 6A and 6B are partial side views of another exemplary embodiment of an embolic protection device;
[0028] FIGS. 7A and 7B are partial side views of another exemplary embodiment of an embolic protection device;
[0029] FIG. 7C is a bottom view of the embolic protection device of FIGS. 7A and 7B;
[0030] FIGS. 8A-8D are partial side views of another exemplary embodiment of an embolic protection device;
[0031] FIG. 9 is a partial side view of another exemplary embodiment of an embolic protection device;
[0032] FIGS. 10A-10D show an exemplary embodiment of a method for capturing embolic debris using an embolic protection device;
[0033] FIG. 11 shows an exemplary embodiment of an embolic debris diversion method using an embolic protection device;
[0034] FIG. 12 shows another exemplary modality of an embolic debris diversion method using an embolic protection device, and
[0035] FIG. 13 shows an exemplary modality of a method of diversion and capture of embolic debris using an embolic protection device and a deflector device. DETAILED DESCRIPTION
[0036] Although certain modalities and examples are described below, those skilled in the art will appreciate that the disclosure of modalities extends beyond the specifically disclosed modalities and / or uses and obvious and equivalent modifications thereof. Thus, it is intended that the scope of the disclosure described here should not be limited by any particular modalities described below.
[0037] Figures 1A-1D illustrate exemplary embodiments of an embolic protection device 100. The device 100 comprises a pig tail catheter 102 having a proximal end 114, distal end 116 and a lumen 118 extending from the proximal end 114 to the distal end 116. The lumen 118 is configured to accommodate a guide wire 740 (Figures 7A and 7B). Pig tail catheter 102 includes a distal portion 104 configured to assume a generally arched shape with at least a semicircle. A side wall of catheter 102 includes at least one opening 108 in the distal portion 104 configured to deliver fluids. The openings 108 (the plural is intended to include modalities in which the distal portion includes an opening 108) are in fluid communication with the lumen 118. The distal portion 104 of catheter 102 includes a longitudinally extending radiopaque marker 106, which is configured to be arched and in the most distal section of catheter 102 when the distal portion 104 is in the generally arched shape. The device 100 additionally comprises a self-expanding embolic filter 110 and an outer sheath 112. The embolic filter 110 is coupled to one side of the proximal catheter 102 for the distal portion 104. When in an expanded configuration, the embolic filter 110 has a generally conical shape extending proximally from a distal opening 140 and a closed proximal end 142. The outer sheath 112 is configured to be circumferentially around at least a portion of catheter 102 and the embolic filter 110. The outer sheath 112 is configured to contain the embolic filter 110 in a collapsed configuration when surrounding the embolic filter 110. The outer sheath 112 is longitudinally movable in relation to catheter 102, and can be moved proximally to release the embolic filter 110 and moved distally to recapture the embolic filter 110 and the embolic material in the embolic filter 110. The embolic filter 110 is configured to fit auto-expand along the proximal longitudinal retraction of the outer coating. A device according to the disclosure here may comprise some or all of the characteristics of the embolic protection device 100 shown in Figures 1A-1D, and is described here, in various combinations and subcombination.
[0038] Pig tail catheter 102 can comprise a flexible material so that it can be manipulated within a lumen of the human body, as described herein. For example, in some embodiments, catheter 102 comprises a polymer (for example, polyurethane, silicone, latex, polytetrafluoroethylene (PTFE), a plastic material, etc.). In some embodiments, catheter 102 comprises a metal-reinforced plastic material (for example, including nitinol, stainless steel, etc.). Other materials are also possible. In some modalities, catheter 102 does not contain latex, which can cause allergic reactions in some patients. In some embodiments, catheter 102 comprises tubes reinforced with braids to advantageously increase the strength of catheter 102. In some embodiments, catheter 102 comprises a braided catheter rod, including a layer of braided wire between two layers of the catheter tube, the which can increase the resistance of catheter 102. In some embodiments, catheter 102 does not include a braided layer, which can increase the flexibility of catheter 102. In some embodiments, catheter 102 comprises a lubricating coating, for example, a coating with a low friction coefficient, to advantageously allow smooth navigation through the tortuous vasculature. In some embodiments, the lining of catheter 102 has antithrombotic properties, advantageously, to inhibit thrombus formation. In some embodiments, catheter 102 has a size (i.e., outside diameter) between about 6 French units and about 9 French units (approximately between about 2 mm and about 3 mm). Other sizes are also possible, for example, depending on the size of the lumen of the target body of a particular patient. In some embodiments, catheter 102 is between about 65 cm (cm) and about 135 cm in length. Other lengths are also possible, for example, to allow insertion of catheter 102 into the femoral, brachial, or radial artery. Catheter 102 can be manufactured, for example, by extrusion, injection molding, or by another suitable process.
[0039] The radiopaque marker 106 extends longitudinally along a section of the distal portion 104 of the catheter 102. When the distal portion 104 is in generally arched shape, the radiopaque marker 106 is also generally arched and in a more distal section of the catheter 102. In some embodiments, the radiopaque marker 106 is about 1 cm long. The radiopaque marker 106 comprises a radiopaque material, for example, platinum, tantalum, tungsten, palladium and / or iridium. Other radiopaque materials are also possible. In some embodiments, a material can be considered radiopaque, for example, if the average atomic number is greater than 24, if the density is greater than about 9.9 g / cm3, etc.
[0040] The embolic filter 110 has a generally conical shape (for example, cone, cone stem, etc.), and is coupled (for example, by adhesion, welding, welding, coupling with a separate component, combinations thereof) , and the like) to one side of catheter 102. As shown in Figures 1B and 1D, the embolic filter 110 includes a distal opening 140 and extends proximally from distal opening 140 and a closed proximal end 142. In some embodiments, the distal opening 140 of the embolic filter 110 has a diameter of about 4.5 cm. The embolic filter 110 can be made in different sizes, having different diameters for patients with different sizes of blood vessels. In some embodiments, the shape of the distal opening 140 of the embolic filter 110 is circular, oval, elliptical, oblong, egg-shaped, combinations thereof and the like. In some embodiments, the embolic filter 110 comprises a shape memory material, including, for example, nitinol, cobalt chromium and / or alloys, such as MP35N, 35NLT, Elgiloy, etc., in some embodiments, the filter embolic 110 comprises a braided mesh. In some embodiments, the embolic filter 110 comprises a porous membrane, for example, a semipermeable polyurethane membrane. In some embodiments, the embolic filter 110 is laser cut from a tube or sheet. In some embodiments, the distal opening 140 of the embolic filter 110 is attached to a self-expanding structure, for example, a nitinol structure. In some embodiments, the embolic filter 110 comprises an antithrombogenic coating (for example, comprising a heparin or thrombin or platelet inhibitor) to advantageously reduce thrombogenicity. The embolic filter 110 is configured to self-expand to a radially expanded open configuration, shown in Figures 1B and 1D, when an outer shell 112 is not limited, for example.
[0041] In some embodiments, for example, as illustrated in Figures 1A and 1B, the embolic filter 110 is coupled to catheter 102 on the side of the catheter facing the distal portion 104 when the distal portion 104 is generally arcuate in shape. In some embodiments, for example, as illustrated in Figures 1C and 1D, the embolic filter 110 is coupled to catheter 102 on the side of the catheter facing away from the distal portion 104 when the distal portion 104 is generally arcuate in shape. The embolic filter 110 can also be coupled to any other side of catheter 102 (for example, orthogonal to a plane of the arcuate member). In some embodiments, the embolic filter 110 is attached to catheter 102 along the entire length of the embolic filter 110. In some embodiments, the embolic filter 110 is attached to catheter 102, at the proximal and / or distal ends of the embolic filter 110 and / or any other points in between.
[0042] The outer shell 112 comprises a hollow tube configured to circumferentially surround at least a portion of catheter 102. The outer shell 112 is longitudinally movable in relation to catheter 102 and is configured to contain, at least partially (for example, contain) the embolic filter 110 in a collapsed configuration, when circumferentially around the embolic filter 110, for example, as shown in Figures 1A and 1C. The outer shell 112 is longitudinally proximally retractable to release the embolic filter 110. The embolic filter 110 expands to the open, expanded configuration when it is not contained by the outer shell 112. In some embodiments, the outer shell 112 extends proximally to the proximal end 114 of catheter 102 so that the user can grasp and manipulate the outer liner 112 directly. In some embodiments, the outer sheath 112 extends proximally along only a portion of catheter 102, and a secondary device (e.g., a push rod, as found in stent implantation systems) is coupled to the outer sheath 112 (for example, the proximal end of the outer shell 112) to allow indirect manipulation of the outer shell 112. The manipulation of the outer shell 112 can be mechanical, manual, combinations thereof, and the like.
[0043] Figure 2A illustrates an exemplary embodiment of an angiography catheter 200. The illustrated embodiment includes a flexible pig tail catheter 202 with a proximal end 214, distal end 216, and a lumen 218 extending from the proximal end 214 to the distal end 216. The lumen 218 is configured to accommodate a guide wire 740 (Figures 7A and 7B). Catheter 202 has a distal portion 204 configured to assume a generally arched shape and a radiopaque marker 206 on the distal portion 204.
[0044] Catheter 202 may comprise a flexible material so as to be manipulable within a lumen of the human body, as described herein. For example, in some embodiments, catheter 202 comprises a polymer (for example, polyurethane, silicone, latex, polytetrafluoroethylene (PTFE), a plastic material, etc.). In some embodiments, catheter 202 comprises metal-reinforced plastic (for example, including nitinol, stainless steel, etc.). Other materials are also possible. In some embodiments, catheter 202 does not contain latex, which can cause allergic reactions in some patients. In some embodiments, catheter 202 comprises a braided catheter rod, including a layer of braided wire between two layers of the catheter tube, which can increase the strength of catheter 202. In some embodiments, catheter 202 does not include a braided layer , which can increase the flexibility of catheter 202. In some embodiments, catheter 202 comprises a lubricating coating, for example, a coating with a low friction coefficient, to advantageously allow smooth navigation through the tortuous vasculature. In some embodiments, the catheter lining 202 has antithrombotic properties, advantageously, to inhibit thrombus formation. In some embodiments, catheter 202 has a size (i.e., outside diameter) between about 6 French units and about 9 French units (approximately between about 2 mm and about 3 mm). Other sizes are also possible, for example, depending on the size of the lumen of the target body of a particular patient. In some embodiments, catheter 202 is between about 65 cm and about 135 cm long. Other lengths are also possible, for example, to allow insertion of catheter 102 into the femoral, brachial, or radial artery. Catheter 202 can be manufactured, for example, by extrusion, injection molding, or by another suitable process.
[0045] As shown in Figure 2A, a distal portion 204 of catheter 202 is configured to assume a generally arched shape, such as a pig tail catheter. When a guide wire is in lumen 218, the guide wire substantially straightens distal portion 204 of catheter 202, allowing catheter 202 to maneuver through lumens of the body, as described herein. When the guidewire is removed from at least the distal portion 204 of the catheter 202, as described herein, the distal portion 204 assumes the generally arcuate shape. In some embodiments, the generally arched shape is at least about a semicircle. In some embodiments, the generally arched shape is at least about three quarters of a circle. In some embodiments, the generally arched shape is at least about 350 °. In some embodiments, the generally arched shape is at least about a full circle. In some embodiments, the generally arched shape is greater than about 90 °. Non-circular arched shapes (eg oval, oblong, elliptical, egg-shaped, spiral, etc.) are also possible, and descriptions of the terms circle, diameter and the like here should be interpreted as taking into account the shape arcuate of distal portion 204. In some embodiments, distal portion 204 of catheter 202 has a diameter of less than about 1 cm, while distal portion 204 is generally arcuate in shape. In some embodiments, the diameter of the distal portion 204 is less than about 0.75 cm. In some embodiments, for example, when the angiography catheter 200 is used during a valve replacement process, a diameter less than about 0.75 cm for the distal portion 204 can facilitate the positioning of the distal portion 204 inside or adjacent to a non-coronary limit of a patient.
[0046] In some embodiments, the proximal end 214 of the catheter 202 is configured to be coupled to a contrast material injector and also the lumen 218 is configured to provide a flow path for the contrast material from the proximal end 214 to the distal end 216 of catheter 202. For example, the proximal end 214 can include a Luer or other accessory. A side wall of catheter 202 can include at least one opening 208 in the distal portion 204. Opening 208 is in fluid communication with lumen 218, so that the contrast material, drugs such as antithrombotics, etc., are injected inwardly. the lumen 218 can be dispersed from opening 208, and optionally from an opening at distal end 216 of catheter 202. In some embodiments, distal end 216 is closed, for example, being configured to collapse internally when not kept open by a guide wire. In some embodiments, the distal end 216 is partially open to allow pressure measurements.
[0047] The angiography catheter 200 illustrated in Figure 2A comprises a radiopaque marker 206. The radiopaque marker 206 comprises a radiopaque material, for example, platinum, tantalum, tungsten, palladium and / or iridium. Other radiopaque materials are also possible. In some embodiments, a material can be considered radiopaque, for example, if the average atomic number is greater than 24, if the density is greater than about 9.9 g / cm3, etc.
[0048] As explained here, during certain cardiac procedures, the precise positioning of instruments and devices can be important. For example, when performing a percutaneous heart valve replacement procedure, the replacement valve device should be placed no more than about 4-6 mm below the lower edge of the aortic ring. Thus, the user can preferably identify the bottom edge of the ring to use as a landmark. The radiopaque marker 206 advantageously allows the user to define and visualize the lower border of the anatomical landmarks of the ring or others. A typical pig tail catheter without a radiopaque marker can be used for visualization during a procedure by injecting contrast material. However, a radiopaque marker or markers on the catheter itself can advantageously reduce the contrast load and allow for uninterrupted identification of the lower border of the aortic ring or other anatomical landmarks.
[0049] The size and placement of the 206 radiopaque marker can provide additional benefits. For example, the preparation of the entire distal portion 204 of the radiopaque catheter 202 may result in the distal portion 204 being too rigid for maneuverability and to assume an arcuate shape. The radiopaque marker 206 illustrated in Figure 2A extends longitudinally along the outer curvature of the distal portion 204 of catheter 202 similar to the radiopaque marker 106 shown in Figures 1A-1D and described herein. When the distal portion 204 of catheter 202 is substantially straight (for example, due to a guide wire being in the lumen 218), the distal end 216 of catheter 202 is the most distal section of catheter 202. When in distal portion 204 of catheter 202 assumes the generally arcuate shape, the distal end 216 of catheter 202 curves at least partially proximally, so that the distal end 216 is not the most distal section of catheter 202. Instead, the most distal section of catheter 202 of the section of catheter 202 beyond which no other section of catheter 202 is distal, which is the curved section of the lower portion of distal portion 204 generally arcuate. The radiopaque marker 206 of Figure 2A is configured to be in the most distal section of catheter 202 when the distal portion 204 is in generally arched shape. This configuration can provide the unique advantage of precisely identifying the most distal edge of catheter 202 when the distal portion 204 is in generally arched shape, thus allowing the user to define an anatomical landmark, for example, the lower edge of the aortic ring. In some embodiments, the radiopaque marker 206 is about 1 cm long. In some embodiments, the radiopaque marker 206 is about 0.8 cm long. In some embodiments, the radiopaque marker 206 is about 0.5 cm long. Other lengths of the 206 radiopaque marker are also possible.
[0050] Figures 2B and 2C show examples of modalities for a radiopaque marker 206. Figure 2B illustrates an embodiment in which the radiopaque marker 206 is generally arched and configured to be in the most distal section of catheter 202 when the distal portion 204 has the generally arched shape. In the embodiment illustrated in Figure 2B, the radiopaque marker 206 is configured to be within the curvature of the most distal section of catheter 202 when the distal portion 204 is generally arcuate in shape. Certain embodiments can advantageously inhibit contact of body tissue by the radiopaque marker 206, which may be more difficult than the catheter 202 material. Figure 2C illustrates a embodiment in which the radiopaque marker 206 comprises a plurality of radiopaque markers 206 across , at least partially (for example, fully) circling catheter 202. Radiopaque markers 206 are configured to be in the most distal section of catheter 202 when distal portion 204 is in generally arched shape. Certain modalities may advantageously show a three-dimensional view of the most distal section of catheter 202 and / or may be visible from different perspectives. Figure 2C shows six radiopaque markers 206; however, more or less radiopaque markers 206 are possible. The spacing and / or thickness of the radiopaque markers 206 may be consistent or may vary from proximal to distal, towards a center or edge of the radiopaque marker 206, etc. Configurations of radiopaque markers 206 other than those shown in Figures 2A-2C are also possible.
[0051] In some embodiments, for example, as shown in Figure 2A, openings 208 are in an outer curved wall of distal portion 204 of catheter 202 when distal portion 204 is generally arcuate in shape. Other opening configurations 208 are also possible. For example, Figure 2D illustrates an embodiment in which the openings 208 are substantially transverse (e.g., transverse) to the plane of the distal portion 204 when the distal portion 204 is generally arcuate in shape. The openings 208 can be on one or both sides of the distal portion 204. For another example, Figure 2E illustrates an embodiment in which the openings 208 are in both the inner and outer curvature of the distal portion 204 of the catheter 202 when the distal portion 204 has a generally arched shape. The openings 208 shown in Figure 2E alternately alternate between the inner and outer curvature, but other arrangements are possible. Certain configurations of the openings 208 can advantageously reduce the forces of fluids that could make the distal portion 204 straight. In some embodiments, openings 208 are located in the same section as distal portion 204, where radiopaque marker 206 is located. In some embodiments, there are no openings 208 in the same section of the distal portion 204 as the radiopaque marker 206.
[0052] In some embodiments, the openings 208 are configured to neutralize forces in the distal portion 204 resulting from fluid ejection from an optional opening at the distal end 216 of catheter 202. For example, the force of the fluid coming out of an opening at the distal end 216 of the catheter 202 it may tend to unwind the distal portion 204, or cause the distal portion 204 to lose its generally arched shape. The openings 208 can be configured so that the force of the fluid exiting the openings 208 is at least partially opposed to any force that tends to unwind the distal portion 204 to assist the distal portion 204 of the catheter 202 to maintain the generally arcuate shape.
[0053] Figures 3A and 3B illustrate an exemplary embodiment of an embolic protection device 300 comprising a catheter 302, an embolic filter 310, and a movable outer coating 312. The catheter 302 can include at least one lumen therethrough. Catheter 302 may comprise a flexible material, such as a polymer (e.g., polyurethane, silicone, latex, polytetrafluoroethylene (PTFE), nylon, a plastic material, etc.), so as to be manipulable within a body lumen, as described herein. In some embodiments, catheter 302 comprises a metal-reinforced plastic material (for example, including nitinol, stainless steel, etc.). Other materials are also possible. In some modalities, catheter 302 does not contain latex, which can cause allergic reactions in some patients. In some embodiments, catheter 302 comprises a braided catheter rod, including a layer of braided wire between two layers of the catheter tube, which can increase the strength of catheter 302. In some embodiments, catheter 302 does not include a braided layer , which can increase the flexibility of catheter 302. In some embodiments, catheter 302 comprises a lubricating coating, for example, a coating with a low friction coefficient, to advantageously allow smooth navigation through the tortuous vasculature. In some embodiments, the lining of catheter 102 has antithrombotic properties, advantageously, to inhibit thrombus formation. In some embodiments, catheter 302 has a size (i.e., outside diameter) between about 6 French units and about 9 French units (approximately between about 2 mm and about 3 mm). Other sizes are also possible, for example, depending on the size of the lumen of the target body of the particular patient. In some embodiments, catheter 302 is between about 65 cm and about 135 cm long. Other lengths are also possible, for example, to allow insertion of catheter 302 into the femoral, brachial, or radial artery. Catheter 302 can be manufactured, for example, by extrusion, injection molding, or by another suitable process.
[0054] The embolic filter 310 has a generally conical shape (for example, cone, cone trunk, etc.), and is coupled (for example, by adhesion, welding, welding, coupling with a separate component, its combinations, and the like ) to one side of catheter 302. In some embodiments, embolic filter 310 is attached to catheter 302 along the entire length of embolic filter 310. In some embodiments, embolic filter 310 is attached to catheter 302, at the proximal ends and / or distal from the embolic filter 310 and / or any other points between them. As shown in Figure 3B, the embolic filter 310 includes a distal opening 340 and extends proximally from the distal opening 340 and a closed proximal end 342. In some embodiments, the distal opening 340 of the embolic filter 310 has a diameter of about 4.5 cm. The embolic filter 310 can be made in different sizes, with different diameters for patients with different sizes of blood vessels. In some embodiments, the shape of the distal opening 340 of the embolic filter 310 is circular, oval, elliptical, oblong, egg-shaped, combinations thereof, and the like. In some embodiments, the embolic filter 310 comprises a shape memory material, including, for example, nitinol, chromium cobalt and / or alloys, such as MP35N, 35NLT, Elgiloy, etc. In some embodiments, the embolic filter 310 comprises a porous membrane, for example, a semipermeable polyurethane membrane. In some embodiments, the embolic filter 310 comprises a braided mesh. In some embodiments, the embolic filter 310 is laser cut from a tube or sheet. In some embodiments, the distal opening 340 of the embolic filter 310 is attached to a self-expanding structure, for example, a nitinol structure. In some embodiments, the embolic filter 310 comprises an antithrombogenic coating (for example, comprising heparin or thrombin or platelet inhibitor), advantageously to reduce thrombogenicity. The embolic filter 310 is configured to self-expand to a radially expanded open configuration, illustrated in Figure 3B, when not coninned, for example, in an outer shell 312.
[0055] In use, the embolic filter 310 is configured to be placed within a lumen of the body, for example, a patient's blood vessels, and in the open, expanded configuration, the perimeter of the open distal end 340 engages the interior wall the lumen. The embolic filter 310 is oriented so that the distal opening 340 is configured to oppose the upstream direction of the blood flow. Because the distal end of the embolic filter 310 fits into the inner wall of the lumen, substantially all (for example, all) blood flow is directed into and through the embolic filter 310 instead of around the embolic filter 310. The embolic filter 310 has a pore size large enough to allow blood to pass freely, but small enough that embolic debris cannot pass through the embolic filter 310. For example, the pore size of the embolic filter 310 may be in the range of about 40 μm to about 200 μm, for example, about 100 μm. The pore size can be uniform across the embolic filter 310. The pore size can vary (for example, increase, decrease and combinations thereof) throughout the embolic filter 310, for example, from the proximal end of the embolic filter 310 to the distal end of the embolic filter 310. Embolic materials or debris (for example, particles resulting from aortic clamping, dislodged plaque, thrombi, other cardiac manipulation, etc.) can therefore be trapped in the embolic filter 310 so that the debris does not migrate to other parts of the body and potentially cause complications. For example, during a procedure on a patient's aortic valve, the embolic filter 310 can be positioned so that the distal opening 340 is in the ascending aorta below the carotid arteries. Embolic debris dislodged during the procedure can be attached to the embolic filter 310 before reaching the carotid arteries, where debris can travel to the brain and cause a stroke or descending aorta, where debris can travel to other parts of the body and cause embolization, for example, of the periphery, kidneys, and / or intestine.
[0056] Outer casing 312 comprises a hollow tube configured to circumferentially surround at least a portion of catheter 302. Outer casing 312 is longitudinally movable with respect to catheter 302 and is configured to contain, at least partially (for example, contain) the embolic filter 310 in a collapsed configuration, when circumferentially around the embolic filter 310, for example, as shown in Figure 3A. The outer sheath 312 is longitudinally proximally retractable to release the embolic filter 310. The embolic filter 310 expands to the expanded configuration, opened when not contained by the outer sheath 312. In some embodiments, the outer sheath 312 extends proximally to the end proximal to catheter 302 so that the user can grasp and manipulate the outer liner 312 directly. In some embodiments, the outer sheath 312 extends proximally along only a portion of catheter 302, and a secondary device (e.g., a push rod, as found in stent implantation systems) is coupled to an outer sheath ( for example, the proximal end of the outer liner 312) to allow indirect manipulation of the outer liner 312. The manipulation of the outer liner 312 can be mechanical, manual, combinations thereof, and the like.
[0057] In some embodiments, the outer sheath 312 may include an optional flap 332 projecting inwardly from the distal end of the outer sheath 312. Catheter 302 may include one or more shoulders 334 (e.g., a distal shoulder 334a and a proximal shoulder 334b) projecting outwardly from an outer wall of catheter 302. The flap 332 of outer liner 312 is configured to engage the flap or flaps 334 of catheter 302 to prevent (for example, preventing) the liner exterior 312 moves too far either in the proximal or distal direction. The flap 332 and the shoulder 334 can be arched, with teeth, and combinations thereof. In some embodiments, the outer liner 312 and / or the catheter 302 comprise projections and / or retainers configured to provide the user with information about the longitudinal position of the outer liner, without inhibiting further movement. In some embodiments, the outer sheath 312 and catheter 302 comprise flaps 332, shoulders 334, and retainers and protrusions (for example, to inhibit the longitudinal movement of the outer sheath 312 too far in any direction, and to provide information on the extent the movement of the outer sheath 312 relative to the catheter 302 (e.g., retracted,% retracted, etc.)).
[0058] The benefits of the 312 outer coating implantation mechanism may include its simplicity, ease of operation and small number of moving parts. The embolic protection device 300 is well suited for use in conjunction with delicate cardiac procedures that are at serious risk. As the duration of the procedure increases, the risk of complications typically increases as well. Therefore, it may be advantageous for the user to be able to deploy and retrieve the embolic filter 310 quickly and easily. A more complicated device may be more difficult to operate and may be more likely to malfunction or cause adverse effects. The ability to move the outer sheath 312 relative to the filter 310 can advantageously allow the user to partially recover the embolic filter 310, for example, to adjust the width of the distal opening 340. In some embodiments, the narrowing of the distal opening 340 allows the user inserts a second catheter or instrument into the lumen of the patient's body and maneuvers the second catheter or instrument around and passes catheter 302 and embolic filter 310, as described herein.
[0059] Figures 4A-4D illustrate an example of an embolic protection device 400 in which the embolic filter 410 is movably coupled to catheter 402 and is movable longitudinally in relation to catheter 402. In some embodiments, the filter embolic 410 is coupled to an intermediate tube 430 that surrounds catheter 402 at least partially circumferentially (for example, circumferentially). The intermediate tube 430 is movable longitudinally in relation to the catheter 402. The outer sheath 412 is configured to, at least partially in a circumferential form (for example, circumferentially) surrounding both the catheter 402 and the intermediate tube 430. The intermediate tube 430 and the outer covering 412 can be moved at the same time and independently. The longitudinal position of the embolic filter 410 in relation to catheter 402 can be adjusted while the embolic filter 410 is in the collapsed configuration or in an expanded implanted or partially implanted configuration. In some embodiments, the perimeter of the distal opening of the embolic filter 410 comprises one or more radiopaque markers to allow the user to view the position of the distal opening, for example, in relation to various anatomical structures. For example, if the user is performing a procedure on the patient's aortic valve and wants to prevent emboli from entering the carotid arteries, radiopaque markers can be used to ensure that the distal opening of the embolic filter 410 is positioned in the ascending aorta upstream of the arteries carotid arteries.
[0060] Figure 4A shows the embolic filter 410 confined in a configuration collapsed by the outer shell 412 and a distal end of the intermediate tube 430 in position a. If the intermediate tube 430 is kept stationary in position a, the outer shell 412 can be retracted to implant the embolic filter 410, as shown in Figure 4C. If intermediate tube 430 and outer sheath 412 are moved at the same time, embolic filter 410 remains confined by outer sheath 412 while the longitudinal position of embolic filter 410 is adjusted. For example, Figure 4B shows the embolic filter 410 still confined by the outer shell 412, but intermediate tube 430 has been retracted so that the distal end of intermediate tube 430 is in position b. If the intermediate tube 430 is then held fixed in position b, the outer shell 412 can be retracted to implant the embolic filter 410, as shown in Figure 4D. The intermediate tube 430 and the outer shell 412 can be moved to adjust the longitudinal position of the embolic filter 410 in an implanted or partially implanted configuration. For example, intermediate tube 430 and outer shell 412 can be moved simultaneously to retract intermediate tube 430 from position a as shown in Figure 4C to position b as shown in Figure 4D. When the embolic filter 410 is partially open, the embolic filter 410 cannot be in contact with the vessel walls and freely mobile, for example, due to the lack of wall affixing. When the embolic filter 410 is fully implanted, all debris dislodged during movement can be attached to the embolic filter 410.
[0061] Figures 5A and 5B illustrate an example of an embolic protection device 500 comprising an implantation mechanism, including a mobile outer casing with four pillars 512. Figure 5C illustrates a cross-sectional view of catheter 502 and the outer coating 512 of Figures 5A and 5B made along line 5C-5C of Figure 5B. Like the outer shell 112 shown in Figures 1A-1D, the outer shell 512 is configured to surround circumferentially surrounding at least a portion of the catheter 502. The outer shell 512 is movable longitudinally relative to the catheter 502 and is configured to contain, at least partially (for example, contain) the embolic filter 510 in a collapsed configuration, when circumferentially around the embolic filter 510, for example, as shown in Figure 5A. The outer sheath 512 is longitudinally proximally retractable to release the embolic filter 510, as shown in Figure 5B.
[0062] As shown in Figures 5A-5C, two abutments 550a can be on the same side of catheter 502 as the embolic filter 510. The other two abutments 550b can be on the opposite side of catheter 502 from the embolic filter 510. In some embodiments, the two side pillars of the filter 550a can be coupled by means of a connector 554 so that the pillars 550a move in unison. The two side pillars without filter 550b can also be coupled via a connector 554 to move in unison. In some embodiments, connectors 554 have a longitudinal length of at least the longitudinal length of the embolic filter 510 when the embolic filter 510 is in the collapsed state. In some embodiments, stabilizers 552 measure the distances between the side pillars of the adjacent filters 550a and the side pillars of the filter 550b, as shown in Figure 5C. The 552 stabilizers can be solid or fenestrated. In some embodiments, stabilizers 552 have a longitudinal length of at least the longitudinal length of the embolic filter 510 when the embolic filter 510 is in the collapsed state. In some embodiments, the stabilizers 552 are fixed in relation to the side pillars without a filter 550b. In some embodiments, the side pillars of the 550a filters have longitudinal grooves configured to receive and act as a track so that the stabilizers 552, and the stabilizers 552 are configured to slide into the grooves.
[0063] In some embodiments, the outer covering 512 comprises a removable clamp 560, shown in Figures 5A and 5B. The clamp 560 is configured to be attached to the proximal ends of the columns 550a, 550b. When the clamp 560 is connected, the side pillars of the filter 550a move in unison with the side pillars of the non-filter 550b so that all four pillars can be moved together, for example, to fully implant the embolic filter 510, for example , as shown in Figure 5B, and / or to retrieve the embolic filter 510. When the clamp 560 is not connected, the side pillars of the filter 550a can be moved independently of the non-filter side pillars 550b. For example, if all four pillars 550a, 550b are retracted to fully implant the embolic filter 510, the non-filter side pillars 550b can be held in place, while the side pillars of the filter 550a are advanced, for example, as shown in Figures 5D and 5E, so that the connector 554 between the side pillars of the filter 550a covers part of the embolic filter 510. If the stabilizers 552 are fixed in relation to the side pillars non-filter 550b, the stabilizers 552 also remain in place and the grooves the side pillars of the filter 550a allow the side pillars of the filter 550a to slide along the stabilizers 552.
[0064] The ability to move independently of the side pillars of the filter 550a and the side pillars of the filter 550b may advantageously allow the user to partially recapture the embolic filter 510, for example, to adjust the width of the distal opening 540. In In some embodiments, the narrowing of the distal opening 540 allows the user to insert a second catheter or an instrument into the patient's body lumen and maneuver the second catheter or an instrument and pass around catheter 502 and embolic filter 510, as described herein. The connector 554 between the side pillars of the filter 550a can also serve as a deflection surface for the second catheter or an instrument to help the user guide the catheter or instrument to pass the embolic filter 510 to the desired location. In some embodiments, the four-pillar outer casing 512 can advantageously allow blood to flow through the body lumen more freely compared to a solid outer casing, which can allow blood to be trapped between the catheter and the casing outside.
[0065] In addition to those described here in detail, a wide variety of mechanisms for the implantation of embolic filters is possible. For example, an implantation system may comprise a portion of an annular coating including protrusions for the inner end, which are guided in bands along the body of the catheter. Certain modalities can advantageously reduce the profile of the catheter. In another example, an implantation system may comprise a threaded sheath, which moves longitudinally with screwing by the user. For another example, an implantation system can comprise a plurality of annular bands that can capture the embolic filter longitudinally and / or circumferentially. Combinations of the implantation systems described here and other implantation systems are also possible.
[0066] Figures 6A and 6B illustrate another exemplary embodiment of an embolic protection device 600. In the embodiment illustrated in Figures 6A and 6B, the embolic filter 610 is placed around catheter 602 instead of being attached to one side of the catheter 602. In some embodiments, this configuration advantageously allows the distal opening 640 of the embolic filter 610 to more fully envelop the interior body lumen wall. For example, when an embolic filter is attached to one side of a catheter, for example, as shown in Figures 3A and 3B, the catheter may be between the embolic filter and the inner body lumen wall, where the embolic filter is attached to the catheter. However, a lateral connection can advantageously allow the user to better maneuver the other instruments around the catheter and the filter.
[0067] The embolic protection device 600 comprises an implantation mechanism for the outer coating 612 similar to that of the embolic protection device 300 illustrated in Figures 3A and 3B, although other implantation mechanisms are also possible (for example, similar to the delivery mechanism) illustrated in Figures 5A5E). The implantation mechanism of the four-pillar outer casing 512 shown in Figures 5A-5E can provide additional benefits when used with the embolic protection device 600. For example, the ability to move the side pillars of the filter 550a and side pillars not of the filter 550b independently it can advantageously allow the user to implant and / or selectively recover one side of the embolic filter 610, for example, to allow other instruments to pass through the side of catheter 602 and filter 610, but to continue to capture debris in the remaining portion implanted. In some embodiments, the open distal end 640 of the embolic filter 612 is not fixed radially with respect to catheter 602. For example, the distal end 640 and the embolic filter 610 cannot be coupled to catheter 602 so that the movement of catheter 602 cause relatively less movement of the distal end 640 of the embolic filter 610. Therefore, the open distal end 640 can maintain contact with the inner body lumen wall, even if the catheter 602 moves radially within the body lumen. In some embodiments, the embolic filter 610 is coupled to an intermediate tube that at least partially circumferentially surrounds catheter 602, for example, similar to the configuration described in relation to Figures 4A-4D.
[0068] Figures 7A-7C illustrate another exemplary embodiment of an embolic protection device 700. Certain aspects of the embolic protection device 700 are compatible with the embolic protection device 100 illustrated in Figures 1A-1D and described here. The device 700 comprises a flexible pigtail catheter 702 with a proximal end 714, distal end 716 and a lumen 718 extending from the proximal end 714 to the distal end 716. The lumen 718 is configured to accommodate a guidewire. Catheter 702 has a distal portion 704 configured to assume a generally arched shape and a radiopaque marker 706 on distal portion 704. Apparatus 700 further comprises a baffle 760 instead of an embolic filter 110.
[0069] Catheter 702 may be similar to catheter 202 shown in Figures 2A-2E and may have any or all of the features and / or advantages shown and described in relation to catheter 202. For example, catheter 702 may comprise a material flexible so that it can be manipulated within a human body lumen, as described herein. For example, in some embodiments, the 702 catheter is composed of a polymer (for example, polyurethane, silicone, latex, polytetrafluoroethylene (PTFE), a plastic material, etc.). In some embodiments, catheter 702 comprises metal-reinforced plastic (for example, including nitinol, stainless steel, etc.). Other materials are also possible. In some modalities, the 702 catheter does not contain latex, which can cause allergic reactions in some patients. In some embodiments, catheter 702 comprises a catheter rod, including a braided layer including a layer of braided wire between two layers of the catheter tube, which can increase the strength of catheter 702. In some embodiments, catheter 702 does not include a braided layer, which can increase the flexibility of catheter 702. In some embodiments, catheter 702 comprises a lubricant coating, for example, a coating with a low friction coefficient, to advantageously allow smooth navigation through the tortuous vasculature. In some embodiments, the catheter lining 702 has antithrombotic properties, advantageously, to inhibit thrombus formation. In some embodiments, catheter 702 has a size (i.e., outside diameter) between about 6 French units and about 9 French French units (approximately between about 2 mm and about 3 mm). Other dimensions are also possible, for example, depending on the size of the target body lumen of a particular patient. In some embodiments, catheter 702 is between about 65 cm and about 135 cm long. Other lengths are also possible, for example, to allow insertion of catheter 702 into the femoral, brachial, or radial artery. Catheter 702 can be manufactured, for example, by extrusion, injection molding, or by another suitable process.
[0070] A distal portion 704 of catheter 702 is configured to assume a generally arched shape, such as a pig tail catheter. When a guidewire is in lumen 718, the guidewire remains substantially straight at the distal portion 704 of catheter 702, allowing catheter 702 to maneuver through the lumens of the body, as described herein. When the guide wire is removed from at least distal portion 704 of catheter 702, as described herein, distal portion 704 takes on the generally arcuate shape. In some embodiments, the arcuate shape is generally at least about a semicircle. In some embodiments, the generally arched shape is at least about three quarters of a circle. In some embodiments, the generally arched shape is at least about 350 °. In some embodiments, the arcuate shape is usually at least about a full circle. In some embodiments, the arcuate shape is generally greater than about 90 °. Non-circular arched shapes (eg oval, oblong, elliptical, egg-shaped, spiral, etc.) are also possible, and descriptions of the terms circle, diameter and the like should be interpreted here as taking into account the arched shape distal portion 704. In some embodiments, distal portion 704 of catheter 702 has a diameter of less than about 1 cm, when distal portion 704 is generally arcuate in shape. In some embodiments, the diameter of the distal portion 704 is less than about 0.75 cm. In some embodiments, for example, when the device 700 is used during a valve replacement process, a diameter less than about 0.75 cm for the distal portion 704 can facilitate the positioning of the distal portion 704 inside or adjacent to a non-coronary cusp of a patient.
[0071] In some embodiments, the proximal end 714 of the catheter 702 is configured to be coupled to a contrast material injector and also the lumen 718 is configured to provide a flow path for the contrast material from the proximal end 714 to the distal end 716 of catheter 702. For example, the proximal end 714 may include a Luer or other accessory. A side wall of the catheter 702 can include at least one opening 708 in the distal portion 704. The opening 708 is in fluid communication with the lumen 718, so that the contrast material, drugs such as antithrombotics, etc. injected into lumen 718 can be dispersed from opening 708, and optionally from an opening at the distal end 716 of catheter 702. In some embodiments, the distal end 716 is closed, for example, being configured to collapse to inside when not held open by a guide wire. In some embodiments, the distal end 716 is partially open to allow pressure measurements.
[0072] The distal portion of device 700 also comprises a radiopaque marker 706. The radiopaque marker 706 comprises a radiopaque material, for example, platinum, tantalum, tungsten, palladium and / or iridium. Other radiopaque materials are also possible. In some embodiments, a material can be considered radiopaque, for example, if the average atomic number is greater than 24, if the density is greater than about 9.9 g / cm3, etc. The radiopaque marker 706 may be similar to the marker of any of the examples of the modalities shown in Figures 2A-2C and described herein. For example, the radiopaque marker 706 may be a longitudinal band that extends along the outer or inner curvature of the distal section, most of the catheter 702 when the distal portion 704 is generally arcuate in shape. The radiopaque marker 706 may comprise a plurality of radiopaque marker 706, at least partially transversely surrounding catheter 702. Another configuration of radiopaque marker 706 is also possible.
[0073] In the modalities with openings 708 in the side wall of the catheter 702 in fluid communication with the lumen 718, the openings 708 can be similar to any of the examples of modalities shown in Figures 2A and 2D, 2E and described herein. For example, the openings 708 may be in an outer curved wall of the distal portion 704 of the catheter 702 when the distal portion 704 is generally arched in shape, with an inner curved wall of the distal portion 704 when the distal portion is the generally arched shape, substantially transverse to the plane of the distal portion 704 when the distal portion 704 is generally arcuate in shape, and / or some combination thereof. Other configurations of 708 openings are also possible.
[0074] Various types and models of deflectors can be used with an embolic protection device, such as device 700. These deflectors can have different shapes and / or sizes and can vary where and how they are connected to the catheter. For example, deflectors can be made in various sizes, for example, to accommodate differences in the patient's anatomy. In some embodiments, the deflector comprises a material with shape memory, including, for example, nitinol, cobalt chromium and / or alloys, such as MP35N, 35NLT, Elgiloy, etc. In some embodiments, the deflector comprises a porous membrane, for example, a semipermeable polyurethane membrane, mounted on a self-expanding structure, for example, a frame comprising a material with shape memory.
[0075] The example of deflector 760 shown in Figures 7A-7C generally has a butterfly or elliptical shape with two wings or petals 760a, 760b extending to both sides of a central axis 764. The wings 760a, 760b can be same or different in shape, size, material, etc. Deflector 760 is coupled to one side of catheter 702 by means of an elongated member 762 which is coupled (for example, by adhesion, welding, welding, coupling using a separate component, combinations thereof, and the like), to one end for the central axis 764 of the baffle 760, and at the other end to the catheter 702. In some embodiments, the elongated member 762 comprises a shape-memory material, including, for example, nitinol, cobalt chromium and / or alloys, such as the MP35N, 35NLT, Elgiloy, etc., which is configured (for example, shape set) to polarize the baffle away from catheter 702. Baffle 760 is configured to release to an open configuration, shown in Figure 7B and 7C, when not limited by, for example, an outer sheath 712. In some embodiments, the baffle 760 is configured to fold along the central axis 764 away from the elongated member 762 so that the wings or petals 760a, 760b come together and the deflet or 760 can be contained in, for example, an outer shell 712, as shown in Figure 7A. As shown in Figure 7A, the baffle 760 can be initially folded and contained in the outer shell 712 such that the wings or petals 760a, 760b are positioned distally from the central axis 764. In some embodiments, the baffle 760 can be initially folded in the opposite direction so that the wings or petals 760a, 760b are positioned proximal to the central axis 764.
[0076] Figures 8A-8D show another exemplary embodiment of an embolic protection device 800 with a deflector. The device 800 is similar to the device 700 shown in Figures 7A-7C and described here as the exception of the deflector 860 design. Deflector 860 is generally convex in shape, for example, as a slightly flattened umbrella, parachute, or a mushroom cap. In some embodiments, a frame may extend along a perimeter of the baffle 860. In some embodiments, one or more frame holders also, or alternatively, extend parallel to the longitudinal or transverse axis of the baffle of 860, for example, to create and / or maintain the expanded form.
[0077] The baffle 860 is coupled to one side of the catheter 802 by means of an elongated member 862. In some embodiments, the elongated member 862 comprises a material with shape memory, including, for example, nitinol, cobalt chromium and / or alloys, such as the MP35N, 35NLT, Elgiloy, etc., which is configured (for example, shape set) to polarize the baffle away from the 802 catheter. In some embodiments, the elongated member 862 includes a plurality of arms ( for example, two arms 862a, 862b), extending from the main body of the elongated member 862, which is coupled (for example, by adhesion, welding, welding, coupling using a separate component, combinations thereof, and the like ) for the 802 catheter. In some embodiments, the elongated member includes a plurality of arms that are coupled (for example, by adhesion, welding, welding, coupling using a separate component, combinations thereof, and the like) for the catheter. In some embodiments, the arms 862a, 862b, or a plurality of elongated members 862 are coupled (for example, by adhesion, welding, welding, coupling using a separate component, combinations thereof, and the like) to different sides of the deflector perimeter 860, for example, as shown in Figures 8A-8C. In some embodiments, the arms 862a, 862b, or a plurality of elongated members 862 are coupled to a part of the baffle 860 with the exception of the perimeter, for example, as shown in Figure 8E. In some embodiments, the arms 862a, 862b, or a plurality of elongated members 862 are coupled to the baffle 860 in the vicinity of a proximal end of the baffle 860, for example, as shown in Figures 8A-8D. This configuration can advantageously allow the baffle 860 to be more easily recovered by the outer shell 812, as described herein. In some of these embodiments, during the retraction of the baffle 860 back to the outer sheath 812, the distal end of the baffle may continue to deflect the debris from the branched arteries. In some embodiments, the arms 862a, 862b, or a plurality of elongated members 862 are coupled to the baffle 860 near a distal end of the baffle 860. In some embodiments, the arms 862a, 862b, or a plurality of elongated members 862 are coupled to the baffle 860 in the vicinity of a middle or central part of the baffle 860. If the baffle 860 comprises a frame, the arms 862a, 862b, or a plurality of elongated members 862 can be coupled to the structure.
[0078] Deflectors 760 and 860 shown in Figures 7A-8D and described here are examples of deflectors, and other designs and configurations are possible. For example, the deflector can be generally flat, convex or concave in shape. The deflector can be coupled to the catheter through an elongated member, such as elongated member 762 shown in Figures 7A and 7B, an elongated member including multiple arms, such as elongated member 862 shown in Figures 8A-8D, multiple elongated elements, their combinations, and the like. Multiple arms can advantageously allow a better distribution of the retraction and of an implantation mechanism as described herein. Fewer arms or a single arm can result in less blood flow obstruction in use and / or can make the device less expensive to manufacture. The elongated member or members can also be coupled to the deflector at various locations. For example, an elongated member can be coupled to the center of the deflector so that the deflector is folded in the configuration contained, for example, as the deflector 760 shown in Figures 7A and 7B. In another example, an elongated member or members may be coupled to the deflector in the vicinity of the proximal end of the deflector, for example, as deflector 860 shown in Figures 8A-8D, or close to the distal end of the deflector.
[0079] Deflectors 760 and 860 are configured to be contained, released, and recaptured by an outer shell 712, 812 implantation mechanism. In some embodiments, the outer covering 712, 812 is similar to the outer covering 112, 312, 412 shown in Figures 1A-1D, 3A-3B and 4A-4D and described herein. The outer sheath 712, 812 comprises a hollow tube configured to circumferentially surround at least a portion of the catheter 702, 802. The outer sheath 712, 812 is longitudinally movable relative to the catheter 702, 802 and is configured to contain, at least partially ( for example, contain) the baffle 760, 860 in a collapsed configuration, when circumferentially surrounded to the baffle 760, 860, for example, as shown in Figures 7A and 8A. The outer sheath 712, 812 is longitudinally proximal retractable to release the baffle 760, 860. The baffle 760, 860 unfolds and the elongated member 762, 862 extends from the catheter 702, 802 to the implanted configuration when it is not contained by the sheath exterior 712, 812, for example, as shown in Figures 7B and 8B-8D.
[0080] In some embodiments, the outer sheath 712, 812 extends proximally to the proximal end of the catheter 702, 802 so that the user can grasp and manipulate the outer sheath 712, 812 directly. In some embodiments, the outer sheath 712, 812 extends proximally along only part of the catheter 702, 802, and a secondary device (e.g., a push rod, as found in stent implantation systems) is attached to the outer sheath 712, 812 (for example, to the proximal end of the outer sheath 712, 812) to allow indirect manipulation of the outer sheath 712, 812. The handling of the outer sheath 712, 812 can be mechanical, manual, combinations thereof , and the like. In some embodiments, catheter 702, 802 and outer sheath 712, 812 may include lips, shoulders, protrusions, and / or restraints, for example, similar to those shown in Figures 3A and 3B and described herein. In some embodiments, the deflector 760, 860 can be movable coupled to catheter 702, 802 and longitudinally movable in relation to catheter 702, 802 by coupling to an intermediate tube, for example, as shown in Figures 4A-4D and described here . In some embodiments, deflector 760, 860 may comprise one or more radiopaque markers, for example, at the proximal and distal ends of deflector 760, 860, to allow the user to view the position of deflector 760, 860, for example, with respect to respect to various anatomical points. For example, if the user is performing a procedure on the patient's aortic valve and wants to prevent emboli from entering the carotid arteries, radiopaque markers can be used to ensure that the deflector 760, 860 is positioned so that it covers the openings to the arteries carotid arteries. In some embodiments, the device 700, 800 may comprise an alternative four-pillar outer cover implantation mechanism, for example, similar to that shown in Figures 5A-5E described herein.
[0081] Although embolic protection devices 700 and 800 specimens comprise pig-tail catheters, deflectors can also be coupled to other types of catheters, such as catheters that do not have distal portions configured to assume a generally arched shape. In some embodiments, deflectors, for example, deflectors 760 and 860, can be attached to the side of a straight catheter.
[0082] In use, the deflector 760, 860 is configured to be placed in the lumen of a main body, for example, blood vessels, of a patient, and in the expanded, open configuration, deflector 760, 860 extends to the opening of a secondary body lumen or lumens or lumens that branch out from the main body lumen. For example, deflector 760, 860 can be placed in the aorta to cover the openings of the arteries that branch out from the aortic arch, for example, the left common brachiocephalic and carotid arteries. Thus, substantially all (for example, all) blood flow to the branched arteries is directed through deflector 760, 860. Deflector 760, 860 has a pore size large enough to allow blood to pass freely, but small enough so that the embolic debris cannot pass through the deflector 760, 860. For example, the pore size of the deflector 760, 860 can range from about 40 μm to about 200 μm, for example, about 100 μm. The pore size can be uniform throughout the deflector 760, 860. The pore size can vary (for example, increase, decrease and combinations thereof) throughout the deflector 760, 860. Embolic materials or debris (for example, the particles resulting from aortic clamping, dislodged plaque, thrombi, other cardiac manipulations, etc.) in the blood flow to the arteries agencies can therefore be trapped or deflected by the deflector 760, 860 so that the debris does not travel to the brain and cause complications.
[0083] Figure 9 shows another exemplary embodiment of an embolic protection device 900 comprising a catheter 902, a deflector 960, an embolic filter 910, and a movable outer coating 912. In some embodiments, the device 900 is similar to the device embolic protection 700, with the addition of the 910 embolic filter. In some embodiments, catheter 902 is a pig tail catheter as shown in Figure 9 and described here. In some embodiments, the deflector 960 and the embolic filter 910 can be coupled to another type of catheter, for example, a catheter without a distal portion configured to assume an arcuate shape. The embolic filter 910 may be similar to the embolic filters 110, 310 shown in Figures 1A-1D and 3A-3B and described herein. In some embodiments, the embolic filter 910 is attached to catheter 902 proximal to deflector 960, for example, as shown in Figure 9. In some embodiments, the embolic filter 910 is attached to catheter 902 distal to deflector 960. In some embodiments, the embolic filter 910 is coupled to the same side of catheter 902 as deflector 960, for example, as shown in Figure 9. In some embodiments, embolic filter 910 is coupled to a different side of catheter 902 than deflector 960.
[0084] The combination of deflector 960 and embolic filter 910 can advantageously provide additional protection against potential complications resulting from the presence of thrombi in the bloodstream. For example, if the embolic filter 910 (for example, the distal end of the embolic filter 910) is distal to the deflector 960, the embolic filter 910 can serve as the primary means of embolic protection, and the deflector 960 can serve as the secondary means embolic protection. If any blood is able to flow around the 910 filter instead of through it, the baffle 960 serves as a protective support device and prevents any debris not captured by the 910 filter from entering the carotid arteries and traveling to the brain. If the embolic filter 910 is proximal to the baffle 960, the baffle 960 can serve as the primary means of embolic protection, and the filter 910 can serve as the secondary means of embolic protection. Deflector 960 first deflects debris from carotid arteries, then embolic filter 910 captures debris (for example, including deflected debris) as blood flows through the descending aorta.
[0085] In some embodiments, catheter 902 and outer sheath 912 may have flaps, protrusions, shoulders and / or holders, for example, similar to those shown in Figures 3A-3B and described herein. For example, the flaps, bosses, projections, and / or holders can be positioned over catheter 902 distal to deflector 960, between deflector 960 and embolic filter 910, and proximal to the embolic filter 910 to fit the flaps, bosses, projections, and / or corresponding holders on the outer cover 912. The tabs, shoulders, projections, and / or holders can advantageously provide the user with information about the longitudinal position of the outer cover 912 so that the user knows when neither, one, or both deflector 960 and embolic filter 910 are implanted. In some embodiments, one or both of the baffles 960 and the embolic filter 910 can be mobilely coupled to catheter 902 by means of an intermediate tube similar to that shown in Figures 4A-4D and described herein. In some embodiments, device 900 may comprise an alternative four-pillar outer cover implantation mechanism, for example, similar to that shown in Figures 5A-5E and described herein.
[0086] In some embodiments, the embolic filter 910 can be arranged around catheter 902, instead of coupled to one side of catheter 902, for example, similar to the embolic filter 610 of device 600 shown in Figures 6A and 6B and here described. In some embodiments, this configuration advantageously allows the embolic filter 910 to fit better on the interior wall of the body lumen, since the position of the catheter 902 inside the body lumen can be affected by the implanted deflector 860.
[0087] As described herein, Figures 1A and 1B illustrate an exemplary embodiment of an embolic protection device 100 comprising a combination of features of the angiography catheter 200 illustrated in Figure 2A and the embolic protection device 300 illustrated in Figures 3A and 3B . Other combinations and subcombination of the characteristics illustrated in Figures 2A-6B and described here are possible and should be considered within the scope of this disclosure. In some embodiments, the distal portion 104 of catheter 102 of the embolic protection device 100 may comprise any of the configurations of openings 208 and radiopaque markers 206 shown in Figures 2A-2E. In some embodiments, the embolic protection device 100 may comprise the movable embolic filter 410 shown in Figures 4A-4D and / or the alternative implantation mechanism shown in Figures 5A and 5B. In some embodiments, the embolic filter 110 can be arranged around catheter 102 like the embolic filter 610 shown in Figures 6A and 6B, instead of being coupled to one side of catheter 102. In some embodiments, the outer shell 112 and the catheter 102 in the embolic protection device 100 may have tabs 332 and shoulders 334, for example, as shown in Figures 3A and 3B, and / or holders and projections to inhibit the longitudinal movement of the outer casing 112 in relation to catheter 102 and / or to provide additional information on the extent of movement of the outer sheath 112 relative to catheter 102. In some embodiments, catheters 302, 402, 502 and / or 602 of embolic protection devices 300, 400, 500 and / or 600 may include a distal portion configured to assume a generally arched shape similar to catheter 102 shown in Figures 1A1D and / or catheters 202 shown in Figures 2A-2E. In some embodiments, embolic filters 310, 410, 510 and / or embolic protection devices 300, 400 and / or 500 can be arranged around catheters 302, 402, and / or 502, such as the embolic filter 610 illustrated in Figures 6A and 6B, instead of being coupled to one side of catheters 302, 402, 502. In some embodiments, embolic protection devices 100, 300, 400 and / or 600 may comprise the implantation mechanism illustrated in Figures 5A and 5B. In some embodiments, embolic protection devices 100, 300, 500 and / or 600 can be coupled to catheters 102, 302, 502 and / or 602, through an intermediate tube, such as intermediate tube 430 illustrated in Figures 4A-4D and the embolic filters 110, 310, 510 and / or 610 can be longitudinally movable in relation to catheters 102, 302, 502 and / or 602. The outer linings 112, 412, 512 and / or 612 and catheters 402, 502, and / or 602 of embolic protection devices 100, 400, 500 and / or 600 may have tabs 332 and shoulders 334, for example, as shown in Figures 3A and 3B, and / or holders and projections to inhibit the longitudinal movement of the coating outer 412, 512, and / or 612 in relation to catheter 402, 502 and / or 602 and / or to provide information on the extent of movement of the outer coating 412, 512, and / or 612 in relation to catheter 402, 502 and / or 602. Other combinations and subcombination of the characteristics described here, even if not explicitly described, are also possible. Embolic Debris Capture Methods
[0088] Figures 10A-10D show an exemplary embodiment of a method of capturing embolic debris during a medical procedure, for example, a procedure for replacing the aortic valve. The method can be carried out using an embolic protection device 100 as described herein. According to some modalities of the method, a 740 guide wire is inserted percutaneously into a lumen of a patient's body, for example, a femoral artery, radial artery, or brachial artery, and navigated with the desired anatomical location, for example, the level of the ascending aorta. The guide wire 740 can be a J-tipped wire having a diameter of about 0.035 inch (about 0.089 centimeter). Other types and dimensions of 740 guide wires are also possible. The proximal end of the guide wire 740 is inserted into the opening of the distal end 116 of the catheter 102. When the guide wire 740 is in the lumen 118 of the catheter 102 in the distal portion 104 of the catheter 102, the distal portion 104 of the catheter is stretched or acquires curvature of the guide wire 740. The distal end 116 of catheter 102 is inserted into the lumen of the body by tracking the lumen 118 of catheter 102 over the guide wire 740, as shown in Figure 10A. The outer diameter of the guide wire 740 is smaller than the inner diameter of the embolic protection device 100 in such a way that the embolic protection device 100 can be traced along the guide wire 740. The inner surface of the lumen 118 and / or the The outer surface of the 740 guide wire may include a lubricant coating to reduce friction during crawling. The guide wire 740 keeps the distal portion 104 of catheter 102 substantially straight (for example, from the generally arcuate state) when catheter 102 is inserted and navigated into the patient's body. The radiopaque marker 106 is used to view and position the distal portion 104 of catheter 102 during screening. The guide wire 740 is removed proximally or retracted sufficiently far to allow the distal portion 104 of catheter 102 to assume the generally arcuate shape, as shown in Figure 10B. The distal portion 104 of catheter 102 is positioned at the desired anatomical landmark, for example, the lower border of the non-coronary cusp of the aortic valve. The radiopaque marker 106 is in the most distal section of the distal portion 104. In some embodiments of the method, the proximal end 114 of catheter 102 is connected to an injector of contrast material, and the contrast material is injected into lumen 118 of the catheter 102, for example, to view the anatomy around device 100. The contrast material exits lumen 118 of catheter 102 through the opening at the distal end 116 of catheter 102 and / or through one or more openings 108 in the side wall of the catheter 102. The contrast material injector can help to visualize and position catheter 102.
[0089] In some embodiments, a second guidewire is inserted percutaneously into a second lumen of the body, for example, the other femoral artery, and a second catheter is tracked along the second guidewire. The second catheter can carry a medical device or instrument, for example, a replacement valve, a valve repair system, or a radio frequency ablation system. Once the second catheter and the associated device or instrument are properly positioned, the outer casing 112 of catheter 102 is longitudinally proximally retracted, allowing the embolic filter 110 to assume the expanded implemented configuration, as shown in Figure 10C. The second guide wire and / or the second catheter can be positioned after the embolic filter 112 is released. The open distal end 140 of the embolic filter 110 is located in the ascending aorta so that blood flows through the filter before it flows into the carotid or descending aorta. In some embodiments, when the embolic filter 110 is implanted, catheter 102 is supported against the wall of the inner lumen, thereby stabilizing catheter 102. The procedure can then be performed, and embolic debris dislodged or, otherwise, in bloodstream during the procedure are captured by the 110 embolic filter.
[0090] After the procedure, the outer casing 112 is advanced distally longitudinally to recapture the embolic filter 110, returning the embolic filter 110 to the collapsed configuration and capturing any embolic debris 750 contained within the embolic filter 110, as shown in Figure 10D . The second catheter and catheter 102 can then be removed from the patient's body. Catheter 102 can be retracted over guide wire 740, without smoothing the distal portion 104 of catheter 102, because the arcuate shape of distal portion 104 is atraumatic to blood vessels.
[0091] Figure 11 illustrates an exemplary modality of a method of bypassing embolic debris during a medical procedure, for example, an aortic valve replacement procedure. The method can be carried out using an embolic protection device 700 as described herein. The method is similar to the method performed using the embolic protection device 100 illustrated in Figures 10A-10D and described herein. Once the pig tail catheter 702 and a second catheter with an associated device or instrument are correctly positioned, the liner 712 is longitudinally proximally retracted to implant the baffle 760, as shown in Figure 11. Baffle 760 covers the mouths or bottlenecks of the arteries that branch from the aortic arch so that blood enters the vessels flows through the deflector 760. The procedure can then be performed, and the embolic debris dislodged or otherwise in the blood flow during the procedure is diverted to away from the carotid arteries by the baffle 760. After the procedure, the outer coating 712 is advanced distally longitudinally to recapture the baffle 760, returning the baffle 760 with the collapsed configuration. The second catheter and catheter 702 can then be removed from the patient's body.
[0092] Figure 12 illustrates another exemplary modality of a method of capturing and diverting embolic debris during a medical procedure using an embolic protection device. Certain aspects of the embolic protection device are similar to the 900 device illustrated in Figure 9 and described here. The embolic filter 1210 is disposed around catheter 1202, instead of coupled to one side of catheter 1202, similar to the embolic filter 610 illustrated in Figures 6A-6B and described herein. The baffle 1260 and the embolic filter 1210 are also coupled to an intermediate tube 1230 that is longitudinally movable in relation to catheter 1202, for example, similar to the embolic protection device 400 illustrated in Figures 4A-4D and described herein. The method is otherwise similar to the method of using devices 100 and 700, as illustrated in Figures 10A-11 and described herein.
[0093] The methods of deflecting and capturing embolic debris during a medical procedure can also be performed using a protective device comprising an embolic filter as described herein and a separate deflector device. Figure 13 illustrates an exemplary embodiment of this method. The embolic protection device of Figure 13 comprises a pig tail catheter 1302 with a radiopaque marker 1306 and an embolic filter 1310 disposed around embolic catheter 1302 similar to filter 610 illustrated in Figures 6A-6B and described herein. As shown, deflector 1360 is mounted on a stem 1362 and contained in an introducer 1368 during insertion. The 1368 introducer is introduced into the patient's body through the right radial artery and navigated through the aortic arch, through the brachiocephalic artery. Once in position, deflector 1360 is implanted from the introducer and pulled back to cover the left common and brachiocephalic carotid artery. In some patients, deflector 1360 may also cover the left subclavian artery. In some embodiments, deflector 1360 can be introduced and implanted before catheter 1302 is navigated to the aortic arch. During a subsequent medical procedure, the deflector 1360 can prevent emboli from entering the carotid arteries, and the embolic filter 1310 can capture emboli deflected by the deflector 1360, before they travel to other parts of the patient's body. The method can also be performed with other embolic protection devices, for example, as described here, and deflector devices that can vary in configuration and how they are introduced into the body and navigated to the aortic arch can also vary.
[0094] In some modalities, the procedure performed is a heart valve replacement procedure, for example, an aortic valve replacement procedure. The embolic protection device 100 is introduced into the patient and connected to the aortic valve as described here and shown in Figures 7A and 7B. The radiopaque marker 106 helps to outline the lower border of the non-coronary cusp to help position a percutaneous implanted aortic valve replacement. Once catheter 102 is positioned, a second guidewire can be inserted percutaneously into a second body lumen and navigated to the level of the ascending aorta or left ventricle. A balloon can be traced along the second guide wire of the aortic valve. The outer shell 112 is then retracted to implant the embolic filter 110. The inflation of the valve balloon can then be performed, and the embolic filters 110 capture 750 embolic debris dislodged during the process or otherwise in the blood flow. After pre-dilation of the balloon, the outer lining 112 is advanced to recapture the embolic filter 110 and any embolic debris 750 contained in the embolic filter 110. The balloon is removed, and a second catheter that carries a valve prosthesis is advanced to the level ascending aorta, tracking the catheter along the second guidewire. The outer liner 112 is retracted again to reimplant the embolic filter 110. The radiopaque marker 106 allows the user to correctly position the prosthesis, for example, about 4 mm to about 6 mm below the lower border of the non-coronary cusp. After the process is completed, the outer shell 112 is advanced to recapture the embolic filter 110 and any captured embolic debris 750, and the catheters are removed from the body. In some embodiments, the second catheter can be removed before advancing the outer liner 112 to recapture the embolic filter 110 and embolic debris 750.
[0095] In some modalities, the process is a process of repairing the heart valves. The method described here can also be adapted for mitral valve repair or replacement procedures. In some modalities, the procedure is a radiofrequency ablation procedure, for example, to treat atrial fibrillation. In some modalities, the procedure is a catheterization procedure.
[0096] Although this disclosure has been described in the context of certain modalities and examples, it should be understood by those skilled in the art that the disclosure extends beyond the modalities specifically described for other alternative modalities and / or obvious and equivalent uses and modifications. In addition, although several variations of the disclosure modalities have been shown and described in detail, other modifications, which are within the scope of this disclosure, will be readily apparent to those skilled in the art. It is also contemplated that the various combinations and subcombination of characteristics and aspects of the specific modalities can be made and still be part of the scope of the description. It should be understood that various characteristics and aspects of the described modalities can be combined with, or replaced by, others in order to form different modes of disclosure modalities. In addition, the dimensions of the various components provided here are examples, and other dimensions can be used. Thus, it is intended that the scope of the description here is not limited by the particular modalities described above.

权利要求:
Claims (15)
[0001]
1. Embolic protection device (100, 300, 400, 500, 600, 700, 800, 900) comprising: an angiography catheter (102, 200, 202, 302, 402, 502, 602, 702, 802, 902 , 1202, 1302) having a proximal end (114, 214, 714), a distal end (116, 216, 716) and a lumen (118, 218, 718) extending from the proximal end (114, 214, 714 ) from the catheter (102, 200, 202, 302, 402, 502, 602, 702, 802, 902, 1202, 1302) to the distal end (116, 216, 716) of the catheter (102, 202, 302, 402, 502, 602, 702, 802, 902, 1202, 1302), the lumen (118, 218, 718) configured to house a guide wire (740, 1040), a distal portion (104, 204, 704) of the catheter (102 , 202, 302, 402, 502, 602, 702, 802, 902, 1202, 1302) configured to assume an arcuate shape that is at least a semicircle; the distal portion (104, 204, 704) of the catheter (102, 202, 302, 402, 502, 602, 702, 802, 902, 1202, 1302) comprising a radiopaque marker (106, 206, 706, 1306) extending longitudinally, configured to be arched and in a more distal section of the catheter (102, 202, 302, 402, 502, 602, 702, 802, 902, 1202, 1302) when the distal portion (104, 204, 704) is at arched shape; characterized by the fact that a self-expanding embolic filter (110, 310, 410, 510, 610, 910, 1210, 1310) coupled to one side of the catheter (102, 202, 302, 402, 502, 602, 702, 802, 902 , 1202, 1302) proximal to the distal portion (104, 204, 704), the embolic filter (110, 310, 410, 510, 610, 910, 1210, 1310) having a conical shape, the embolic filter (110, 310 , 410, 510, 610, 910, 1210, 1310) comprising a distal opening (140, 340, 540, 640) having an elliptical shape and extending proximally from the distal opening (140, 340, 540, 640) to a closed proximal end (142, 342); wherein the distal opening (140, 340, 540, 640) of the embolic filter (110, 310, 410, 510, 610, 910, 1210, 1310) faces the distal portion (104, 204, 704) and is fixed a self-expanding structure configured to self-expand into a radially expanded open configuration; and an implantation mechanism (112, 312, 412, 512, 612, 712, 812, 912) circumferentially arranged around at least a portion of the catheter (102, 202, 302, 402, 502, 602, 702, 802, 902, 1202, 1302) and longitudinally movable in relation to the catheter (102, 202, 302, 402, 502, 602, 702, 802, 902, 1202, 1302), the implantation mechanism (112, 312, 412, 512, 612, 712, 812, 912) is configured to contain the embolic filter (110, 310, 410, 510, 610, 910, 1210, 1310) in a collapsed configuration, and the embolic filter (110, 310, 410, 510, 610, 910, 1210, 1310) configured to self-expand in view of the proximal longitudinal retraction of the implantation mechanism (112, 312, 412, 512, 612, 712, 812, 912).
[0002]
2. Embolic protection device (100, 300, 400, 500, 600, 700, 800, 900), according to claim 1, characterized by the fact that the embolic filter (110, 310, 410, 510, 610, 910, 1210, 1310) comprises a braided nitinol mesh.
[0003]
3. Embolic protection device (100, 300, 400, 500, 600, 700, 800, 900), according to claim 1 or 2, characterized by the fact that the embolic filter (110, 310, 410, 510, 610, 910, 1210, 1310) is movably coupled to the catheter (102, 202, 302, 402, 502, 602, 702, 802, 902, 1202, 1302) and is longitudinally movable in relation to the catheter (102, 202 , 302, 402, 502, 602, 702, 802, 902, 1202, 1302).
[0004]
4. Embolic protection device (100, 300, 400, 500, 600, 700, 800, 900), according to any one of claims 1 to 3, characterized by the fact that the arcuate shape of the distal portion (104, 204, 704) is towards the side of the catheter (102, 202, 302, 402, 502, 602, 702, 802, 902, 1202, 1302) for which the embolic filter (110, 310, 410, 510, 610 , 910, 1210, 1310) is coupled.
[0005]
5. Embolic protection device (100, 300, 400, 500, 600, 700, 800, 900), according to any one of claims 1 to 4, characterized by the fact that it still comprises a self-expanding deflector (760, 860, 960, 1260, 1360) coupled to the catheter (102, 202, 302, 402, 502, 602, 702, 802, 902, 1202, 1302) proximal to the distal portion (104, 204, 704), the deflector (760, 860, 960, 1260, 1360) having a longitudinal axis parallel to a longitudinal axis of the catheter (102, 202, 302, 402, 502, 602, 702, 802, 902, 1202, 1302).
[0006]
6. Embolic protection device (100, 300, 400, 500, 600, 700, 800, 900), according to any one of claims 1 to 5, characterized by the fact that the radiopaque marker (106, 206, 706, 1306) is located on the outer curvature of the distal portion (104, 204, 704) of the catheter (102, 202, 302, 402, 502, 602, 702, 802, 902, 1202, 1302) when the distal portion (104, 204 , 704) takes an arched shape.
[0007]
7. Embolic protection device (100, 300, 400, 500, 600, 700, 800, 900), according to any one of claims 1 to 6, characterized by the fact that the distal opening (140, 340, 540, 640) has a diameter of 4.5 cm.
[0008]
8. Embolic protection device (100, 300, 400, 500, 600, 700, 800, 900) according to any one of claims 1 to 7, characterized by the fact that the embolic filter (110, 310, 410, 510, 610, 910, 1210, 1310) comprises a plurality of pores having a pore size of 40 to 200 French units.
[0009]
9. Embolic protection device (100, 300, 400, 500, 600, 700, 800, 900), according to any one of claims 1 to 8, characterized by the fact that the embolic filter (110, 310, 410, 510, 610, 910, 1210, 1310) comprises a polyurethane membrane or a nitinol mesh.
[0010]
10. Embolic protection device (100, 300, 400, 500, 600, 700, 800, 900) according to any one of claims 1 to 9, characterized by the fact that the embolic filter (110, 310, 410, 510, 610, 910, 1210, 1310) is movably coupled to the catheter (102, 202, 302, 402, 502, 602, 702, 802, 902, 1202, 1302) through a fixation to an intermediate tube (430 , 1230) coupled to the catheter (102, 202, 302, 402, 502, 602, 702, 802, 902, 1202, 1302), in which the intermediate tube (430, 1230) circumferentially surrounds the catheter (102, 202, 302 , 402, 502, 602, 702, 802, 902, 1202, 1302) and is mobile longitudinally relative to the catheter (102, 202, 302, 402, 502, 602, 702, 802, 902, 1202, 1302), in that the implantation mechanism (112, 312, 412, 512, 612, 712, 812, 912) is configured to circumferentially surround both catheters (102, 202, 302, 402, 502, 602, 702, 802, 902, 1202 , 1302) and the intermediate tube (430, 1230).
[0011]
11. Embolic protection device (100, 300, 400, 500, 600, 700, 800, 900) according to any one of claims 1 to 10, characterized by the fact that the implantation mechanism (112, 312, 412 , 512, 612, 712, 812, 912) comprises an outer sheath (112, 312, 412, 512, 612, 712, 812, 912) movable longitudinally relative to the embolic filter (110, 310, 410, 510, 610, 910, 1210, 1310), where the outer sheath (112, 312, 412, 512, 612, 712, 812, 912) is configured to contain the embolic filter (110, 310, 410, 510, 610, 910, 1210 , 1310) in a collapsed state when the coating is around the embolic filter (110, 310, 410, 510, 610, 910, 1210, 1310), and the embolic filter (110, 310, 410, 510, 610, 910 , 1210, 1310) is configured to self-expand against the proximal longitudinal retraction of the outer sheath (112, 312, 412, 512, 612, 712, 812, 912).
[0012]
12. Embolic protection device (100, 300, 400, 500, 600, 700, 800, 900) according to any one of claims 1 to 11, characterized by the fact that it still comprises a mechanism to determine the extent of movement of the implantation mechanism (112, 312, 412, 512, 612, 712, 812, 912) related to the catheter (102, 202, 302, 402, 502, 602, 702, 802, 902, 1202, 1302) to adjust the distal opening width (140, 340, 540, 640).
[0013]
13. Embolic protection device (100, 300, 400, 500, 600, 700, 800, 900) according to any one of claims 1 to 12, characterized by the fact that the mechanism for determining the extent of movement of the mechanism implantation (112, 312, 412, 512, 612, 712, 812, 912) related to the catheter (102, 202, 302, 402, 502, 602, 702, 802, 902, 1202, 1302) comprises lips (332) , projections (334), protrusions, restraints or any combination thereof in the catheter (102, 202, 302, 402, 502, 602, 702, 802, 902, 1202, 1302), outer sheath (112, 312, 412, 512 , 612, 712, 812, 912), or both.
[0014]
14. Embolic protection device (100, 300, 400, 500, 600, 700, 800, 900) according to any one of claims 1 to 13, characterized by the fact that the catheter (102, 202, 302, 402 , 502, 602, 702, 802, 902, 1202, 1302) has an outer diameter of 2 mm to 3 mm.
[0015]
15. Embolic protection device (100, 300, 400, 500, 600, 700, 800, 900) according to any one of claims 1 to 14, characterized in that the arcuate shape is at least 350 °.

类似技术:

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公开号 | 公开日 | 专利标题

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BR112013017310B1|2020-12-29|embolic protection device

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JP2016533228A|2016-10-27|Embolization prevention medical device

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同族专利:

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公开号 | 公开日

---

WO2012094195A1|2012-07-12|

---

ES2686018T3|2018-10-16|

---

AU2011353593B2|2015-10-08|

---

RU2597371C2|2016-09-10|

---

KR102094046B1|2020-03-26|

---

KR20140034752A|2014-03-20|

---

EP2661305A1|2013-11-13|

---

IL227099A|2018-07-31|

---

CA2823198C|2019-03-26|

---

JP2014505537A|2014-03-06|

---

JP5896575B2|2016-03-30|

---

EP2661305A4|2015-11-18|

---

EP2661305B1|2018-06-06|

---

US8948848B2|2015-02-03|

---

AU2011353593A1|2013-07-11|

---

CA2823198A1|2012-07-12|

---

RU2013136918A|2015-02-20|

---

US20120179033A1|2012-07-12|

---

BR112013017310A2|2016-10-04|

---

DK2661305T3|2018-09-03|

---

PL2661305T3|2018-11-30|

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法律状态:
2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

---

2019-08-27| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

---

2020-05-19| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|

---

2020-11-03| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

---

2020-12-29| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 27/12/2011, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US201161460660P| true| 2011-01-07|2011-01-07|

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