Embolic protection device

Abstract

The present disclosure includes devices and methods of a distal protection system. The system may include a delivery catheter, an embolic protection device, and a retrieval catheter. An improved embolic protection device is provided that includes a wire, an expandable ring connected to a porous filter with two legs for attaching the ring to the wire. Embolic protection devices usable with lumens of a wide range of diameters are disclosed.

Description

[0001] Cross - reference to related applications

[0002] This application claims the benefit of U.S. Patent Application No. 18 / 213,178, filed Jun. 22, 2023, which claims the benefit of U.S. Patent Application No. 63 / 354,668, filed Jun. 22, 2022, the entire content of which is incorporated herein by reference. Technical Field

[0003] This application relates to embolic protection devices, systems, and methods of providing embolic protection. Background Art

[0004] Millions of people in the United States alone suffer from peripheral artery disease (PAD) and coronary artery disease (CAD). PAD and CAD are silent and dangerous diseases that can have catastrophic consequences if left untreated. CAD is the leading cause of death in the United States, and PAD is the leading cause of amputation in patients.

[0005] Coronary artery disease (CAD) and peripheral artery disease (PAD) are both caused by a gradual narrowing of blood vessels, most commonly due to atherosclerosis, which is the accumulation of plaque or fatty substances on the inner lining of the artery wall. Over time, this material hardens and thickens, potentially interfering with blood circulation in the arms, legs, stomach, and kidneys. This narrowing forms lesions that can completely or partially restrict blood flow through the artery. Blood circulation to the brain and heart may be reduced, increasing the risk of stroke and heart disease.

[0006] Procedures for treating arterial occlusive diseases (such as angioplasty, atherectomy, and stenting) often result in the formation of thrombi and / or the detachment of atherosclerotic material from the inner wall of the blood vessel and into the bloodstream. The detached material (such as plaque) is called an atherosclerotic embolus and may be large enough to block downstream blood vessels, which can then impede blood flow to tissues. In addition, a thrombus (called a thromboembolus) may be large enough to block downstream blood flow.

[0007] There are many previously known interventional systems and methods that employ a filtering mechanism designed to capture material detached from the blood vessel wall during the treatment or diagnosis of vascular diseases. Many newer devices employ an expandable filter disposed at the distal end of a guide wire. These filters have various configurations, such as a mesh or microporous membrane in the form of a sleeve, parachute, or basket, which is attached to the guide wire or other delivery mechanism by struts, wires, ribs, or a frame. The mesh is typically made of interwoven or braided fibers or wires made of, for example, stainless steel, nitinol, platinum alloy, polyester, nylon, or porous plastic. The microporous membrane is typically made of a polymeric material, such as polypropylene, polyurethane, polyester, polyethylene terephthalate, polytetrafluoroethylene, or a combination thereof.

[0008] Because the sizes of human arteries vary, users of embolic protection devices must stock embolic protection devices of various sizes, as known embolic protection devices are only suitable for a narrow range of vessel sizes. For example, the diameter of the coronary artery is typically up to 5 millimeters at most, and the diameter of non-aortic peripheral vessels is typically up to 10 millimeters at most. This document introduces an embolic filter designed for multiple vessel sizes.

[0009] There is still a need for new embolic protection devices that are more powerful than existing devices, such as those capable of operating under a wider range of conditions and vessel sizes.

[0010] All U.S. patents and applications and all other published documents mentioned anywhere in this application are hereby incorporated by reference in their entirety.

[0011] Some of the claimed embodiments of the present invention are briefly outlined below, but do not limit the scope of the present invention. Other details of the embodiments summarized in the present invention and / or additional embodiments of the present invention can be found in the following detailed description.

[0012] A brief abstract of the technical disclosure is also provided in the specification, solely for compliance with 37 C.F.R. 1.72. The abstract is not intended to be used to interpret the scope of the claims. Summary of the Invention

[0013] An embolic protection device deployed in a blood vessel or cavity in the body for collecting loose and / or shed debris is described herein.

[0014] In one embodiment, the distal protection device includes a guide wire with an expandable ring and a filter mounted on the wire near the distal end. The expandable ring includes two legs connected to the expandable ring, and the two legs extend from the ring at an angle of approximately 90° and are connected to the wire.

[0015] In another embodiment, the embolic protection device includes a guide wire with an expandable ring and a filter mounted on the wire near the distal end. The expandable ring includes two legs connected to the expandable ring, and the two legs extend from the ring at an angle of approximately 90° and are connected to the wire. The expandable ring includes a preferential bending region at a position 180° from the wire, and this region may include a small U-shaped portion of the wire of the expandable ring.

[0016] In another embodiment, the embolic protection device includes a guide wire with an expandable ring and a filter mounted on the wire near the distal end. The expandable ring includes two legs connected to the expandable ring, and the two legs extend from the ring at an angle of approximately 90° and are connected to the wire. In the static configuration, when the expandable ring is not restricted within a structure such as a body lumen, the ring has an oval or elliptical shape, where the smaller diameter of the ring is perpendicular to the guide wire.

[0017] In another embodiment, the filter material has a plurality of pores. To increase the efficiency of the filter, it is preferred to have the maximum number of pores. In this embodiment, the pores are arranged to avoid perforations or preferential tear lines in the filter.

[0018] In another embodiment, the device includes a delivery catheter sized to accommodate the embolic protection device. The delivery catheter can be used to cross a lesion. In some examples, the distal end of the wire is external to the distal end of the delivery catheter when crossing the lesion. In some examples, a retrieval catheter is used to capture the expandable distal protection device for removal from the body.

[0019] These and other embodiments that constitute the features of the present invention are particularly pointed out in the appended claims, which form a part of the present invention. However, for a better understanding of the present invention, its advantages, and the purposes obtained by using the present invention, reference may be made to the accompanying drawings and the accompanying explanatory matter that form a part of the present invention, in which various embodiments of the present invention are illustrated and described. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1A is a schematic view of an embolic protection device in accordance with multiple embodiments of the present disclosure.

[0021] Figure 1B is a schematic view of an embolic protection device in accordance with multiple embodiments of the present disclosure.

[0022] Figure 2 is a schematic view of an expandable frame of an embolic protection device in accordance with multiple embodiments of the present invention.

[0023] Figure 3 is a schematic view of an embolic protection device in a distal view in accordance with multiple embodiments of the present invention.

[0024] Figure 4 is a schematic view of an expandable frame of an embolic protection device in accordance with multiple embodiments of the present invention.

[0025] Figure 5 is a schematic view of a filter material of an embolic protection device in accordance with multiple embodiments of the present invention.

[0026] Figure 6A and 6B illustrate embodiments of the present invention for two different diameter blood vessels.

[0027] Figure 7A and 7B illustrate embodiments of the present invention for two different diameter blood vessels. DETAILED DESCRIPTION

[0028] Although the present invention may be embodied in many different forms, specific embodiments of the invention are described in detail herein. This description is illustrative of the principles of the invention and is not intended to limit the invention to the particular embodiments shown.

[0029] For purposes of this disclosure, like reference numerals in the figures shall refer to like features unless otherwise indicated.

[0030] The present disclosure includes methods and devices for providing embolic protection. In one embodiment, a distal protection device includes a guidewire with an expandable ring and a filter mounted on the wire near the distal end. The expandable ring includes two legs connected to the expandable ring, the two legs extending from the ring at an angle of approximately 90° and connected to the wire. In one embodiment, the expandable ring includes a preferential bending region, which may include a small U-shaped portion of the wire of the expandable ring. In one embodiment, the expandable ring includes an oval or elliptical shape, with the smaller diameter of the ring perpendicular to the guidewire. In one embodiment, the filter material is provided with a plurality of holes arranged to avoid perforating a preferential tear line. In one embodiment, the distal protection device is designed to operate in a wide range of lumen diameters.

[0031] Example devices include a delivery catheter sized to accommodate the embolic protection device. The delivery catheter is for passing through a lesion. In some examples, the distal end of the wire is external to the distal end of the delivery catheter when passing through the lesion. In some examples, a retrieval catheter is used to capture the expandable distal protection device for removal from the body.

[0032] In the following detailed description of the present disclosure, reference is made to the accompanying drawings which form a part hereof, and in which are shown by way of illustration one or more embodiments of how the present disclosure may be practiced. These embodiments are described in sufficient detail to enable one of ordinary skill in the art to practice the embodiments of the present disclosure, and it should be understood that other embodiments may be used and that process, electrical, and structural changes may be made without departing from the scope of the present disclosure.

[0033] As used herein, indicators such as "X", "Y", "N", "M", etc., particularly with respect to reference numerals in the figures, represent the number of specific features that may be included as so designated. It should also be understood that the terms used herein are for the purpose of describing particular embodiments only and are not intended to be limiting. As used herein, the singular forms "a", "an", and "the" may include singular and plural referents unless the context clearly dictates otherwise. Additionally, "a plurality of", "at least one", and "one or more" (e.g., a plurality of pivot points) may refer to one or more pivot points, and "a plurality of" is intended to refer to more than one such thing. Further, throughout this application, "can" and "may" are used in an enabling sense (i.e., having the potential, being able to), rather than in a mandatory sense (i.e., must). The term "comprising" and its derivatives mean "including but not limited to". The terms "coupled" and "connected" refer to a physical connection, either directly or indirectly, or for approaching and moving a movable handle member, depending on the context.

[0034] It should be understood that the elements shown in various embodiments herein may be added, exchanged, and / or eliminated to provide multiple additional embodiments of the present disclosure. Additionally, the scale and / or relative scale of the elements provided in the figures are intended to illustrate certain embodiments of the present disclosure and should not be considered limiting.

[0035] Figure 1A is a perspective schematic view of an embolic protection device according to multiple embodiments of the present disclosure. In this example, the embolic protection device 100 may include a guide wire 102 attached to an expandable frame 104. In some examples, the guide wire extends through the interior of a filter 106 and is attached to the distal end of the filter material 106. The filter 106 includes a plurality of holes 112. The expandable frame includes legs 108 and 110 that are attached to the frame at an angle of approximately 90°. In some embodiments, the angle is between 70° and 90° or between 80° and 100°. In some embodiments, the legs 108 and 110 and the frame 104 are made from a single wire that is heat set into the appropriate shape. The proximal ends of the legs 108 and 110 are attached to the wire 102 at 114, and the length of the legs is approximately 2 to 20 millimeters, preferably 5 to 10 millimeters. The joint 114 may include welding, glue, or other adhesives, or may include a heat seal, shrink, or sleeve that is bonded to the legs 108 and 110 and to the wire 102.

[0036] Figure 1BSchematic diagram of a bottom view of an embolization protection device according to multiple embodiments of the present disclosure. In this example, the embolization protection device 100 may include a guide wire 102 attached to an expandable frame or ring 104. The expandable frame 104 includes legs 108 and 110 attached to the frame at approximately right angles. In some embodiments, the legs 108 and 110 and the frame 104 are made of a single wire that is heat-set into the appropriate shape. As shown, the leg 110 is located on one side of the wire 102 and extends from a joint or connector 114 to the expandable ring 104. The other leg is located on the other side of the wire 102 and also extends from the joint 114 to the expandable ring 104. As shown, the two legs 108 and 110 extend in a proximal direction from the frame 104, but in other embodiments, they may extend in a distal direction. In some embodiments, the legs 108 and 110 (including the approximate right angles where they transition to the ring 104) are positioned on the side of the wire opposite the ring 104 such that they cross each other, and the wire 102 is positioned between this crossing location and the ring 104.

[0037] As Figure 1B shown, in some embodiments, the first wire in the two legs crosses the second wire. Following the wire path that forms the legs 108 and 110 and the frame 104, the wire of the first leg 110 starts from the joint 114 and extends along the first side of the wire 102. Before forming the frame 104, the first wire crosses the second wire, extends under the wire 102, and enters the frame 104 on the second side of the wire 102. The wire of the frame 104 continues from the second side of the wire 102, extends over the top of the wire 102 to the wire of the frame 104 on the first side of the wire 102. The wire of the frame 104 then extends under the wire 102, crosses the first leg 110, and subsequently forms the second leg 108, which extends on the second side of the wire 102 until it reaches the joint 114. Although this description is directed to a single wire, multiple wires may be used, including wires having different sizes or physical properties. Although this description has a specific number of crossings, bends, and direction changes, the description here is minimal; other and / or additional crossings, bends, and direction changes may also be used.

[0038] Figure 2 Schematic diagram of the wires of the legs 108 and 110 and the ring 104 according to multiple embodiments of the present invention. As shown, the wire of the ring 104 starts from the leg 108 and extends in one direction, then extends through an approximate right angle, then extends around the ring 104, then extends through another approximate right angle, and crosses over or passes under the leg 108 before readjusting to the direction in which the leg 108 extends.

[0039] Figure 3is a view of an embodiment from the proximal end (looking distally) of an embolic protection device in accordance with multiple embodiments of the present disclosure. In this embodiment, when the distal protection device is expanded, stationary, and not constrained within a lumen or other structure, the loop 104 has an elliptical, oval, egg-shaped, or other non-circular shape. In this embodiment, the distance A extending through the loop 104 in a direction perpendicular to and passing through the wire 102 has a vertical distance that is less than the horizontal distance B extending through the loop 104. In some embodiments, the distance B is approximately 5%, 10%, 15%, 20%, or more greater than the distance A. The non-circular shape helps ensure that when the device 100 is placed within a lumen, the loop 104 is positioned to contact the lumen wall. In some prior art devices, when the device is placed within a lumen, particularly within a tortuous lumen such as a blood vessel, certain portions of the expandable loop may be pulled apart and not contact the lumen wall. In one non-limiting embodiment, to create an embolic protection device that can operate within a blood vessel having a diameter of 4 millimeters to 10 millimeters, the distance A is approximately 9.2 millimeters and the distance B is approximately 11 millimeters.

[0040] In some embodiments, the height of the elliptical loop 104 may be greater than the width. In some embodiments, the distance A is approximately 5%, 10%, 15%, 20%, or more greater than the distance B.

[0041] Figure 4 is a schematic illustration of an expandable loop 104 in accordance with multiple embodiments of the present invention, the loop including a preferential bending region 116. The preferential bending region 116 may include a U-shaped, V-shaped, or omega-shaped portion of the wire of the expandable loop 104. The preferential bending region 116 is located at a position approximately 180° from the legs 108 and 110. The preferential bending region 116 helps collapse the distal protection device into the delivery catheter and / or retrieval catheter because the loop 104 will bend easily and collapse easily into the lumen of the delivery catheter and / or retrieval catheter at this location. In one non-limiting embodiment, the wire of the loop 104 is composed of nitinol, has a diameter of 0.006 inches, the radius of the preferential bending region 116 is 0.020 inches, and the depth is from 0.030 inches to 0.040 inches. The preferential bending region 116 may include any suitable shape that promotes deformation of the loop 104 at the preferential bending region 116. Although Figure 4 shows the preferential bending region 116 protruding outside of the basic cavity formed by the loop 104, in some embodiments, the preferential bending region 116 may extend into the cavity. In some embodiments, the preferential bending region 116 includes a higher curvature than other portions of the loop 104. In some embodiments, the preferential bending region 116 includes one or more inflection changes in the direction of the curvature.

[0042] Figure 5Schematic diagram of a filter material 106 according to multiple embodiments of the present disclosure. Holes 112 are formed in the filter material 106 to maximize the number of holes without significantly weakening the filter 106 due to the formation of preferential tear or perforation lines. The filter 106 requires the maximum number of holes to increase fluid flow when using an embolization protection device. For example, increasing blood flow when the filter is used in an artery or vein. The fluid flow can be increased by increasing the diameter of the holes, but this will result in a decrease in filter efficiency because larger particles will pass through the filter. As Figure 5 shown, the filter 106 includes a plurality of holes 112. The strength of the filter material is affected by the number of holes and the distance from the center of one hole to the center of another hole among the plurality of holes. To increase the number of holes and maintain an acceptable center-to-center distance of the holes, the holes are staggered along the longitudinal axis of the filter. 114, 116, 118, and 120 represent a row of holes extending around the filter. As shown, the holes in rows 114 and 118 are aligned relative to each other in the longitudinal axis direction of the filter. Similarly, the holes in rows 116 and 120 are also aligned. The holes in rows 116 and 120 are staggered with respect to the holes in rows 114 and 118 because the holes in rows 116 and 120 are generally aligned with the material between the holes in rows 116 and 120. This staggered pattern limits the formation of perforation or preferential tear lines.

[0043] In some embodiments, the filter 106 includes a thermoplastic polymer or a thermoplastic elastomer. In some embodiments, the filter 106 includes a thermoplastic polyurethane or a thermoplastic polyurethane elastomer. In some embodiments, the filter 106 includes polyurethane. In some embodiments, the filter 106 includes a thermoplastic polyurethane, which includes an aromatic thermoplastic polyurethane. In some embodiments, the filter is made of a flat polymer that is rolled into a cone and sealed. In some embodiments, the filter 106 is formed in a cone shape. In some embodiments, the thickness of the filter 106 is 0.02 to 0.1 mm or 0.025 to 0.05 mm. In one embodiment, the thickness of the filter 106 is between 0.03 mm and 0.04 mm. In some embodiments, the diameter of the holes 112 can be 0.1 to 0.2 mm, or 0.14 to 0.16 mm. In one embodiment, the diameter of the holes 112 is 0.15 mm. In some embodiments, the center-to-center spacing of the holes 112 is 0.2 to 0.5 mm or 0.3 to 0.4 mm. In one embodiment, the center-to-center spacing of the holes 112 is 0.35 mm.

[0044] Figure 6A and 6BShows a distal protection device deployed within the lumen 122. In some embodiments, the embolic protection device 100 is designed to operate within a wide range of lumen diameters. In one example, the device 100 will operate in lumens having diameters of 4 to 12 millimeters or 5 to 10 millimeters. When positioned within a lumen of larger diameter, legs 110 and 108 are generally or substantially parallel to wire 102. When positioned within a lumen of smaller diameter, legs 108 and 110 extend at an angle to wire 102. The proximal ends of legs 108 and 110 are attached to wire 102 at 114. When positioned within a lumen of smaller diameter, each of legs 108 and 110 extends at an angle of 5° to 25° to wire 102. In Figure 6A wherein, the lumen 122 has a larger diameter. Ring 104 is positioned generally perpendicular to lumen 122 and wire 102, and legs 108 and 110 extend generally parallel to wire 102. In Figure 6B wherein, the diameter of lumen 122 is smaller. Ring 104 is positioned at an angle relative to lumen 122 and wire 102, and legs 108 and 110 extend at an arbitrary angle to wire 102 and connector 114. In one embodiment where lumen 122 is a blood vessel, Figure 6A represents a blood vessel having a diameter of 8 to 12 millimeters, while Figure 6B represents a blood vessel having a diameter of 4 to 7 millimeters.

[0045] In some embodiments, the embolic protection device 100 includes a guide wire 102, a support member 130, and a filter 106. In some embodiments, the support member 130 includes a first leg 108, a ring 104, and a second leg 110 as described herein. In some embodiments, the support member 130 includes a single piece of material. In some embodiments, the support member 130 includes a continuous wire. In some embodiments, the support member 130 is attached to the guide wire 102 at a junction 114 at a first end and extends along the length of the guide wire 102 as the first leg 108, positioned on a first side of the guide wire 102. In some embodiments, the support member 130 then bends and transitions into the ring 104, which can be shaped as described herein and includes an aperture 132. In some embodiments, the support member 130 crosses itself and bends at the transition from the ring 104 to the second leg 110. The second leg 110 can be located on a second side of the guide wire 102, and the support member 130 can be attached to the guide wire 102 at a second end at the junction 114. In some embodiments, a first portion of the support member 130 spans a second portion of the support member 130.

[0046] In some embodiments, the first leg 108 is located on a first side of the longitudinal bisecting plane, while the second leg 110 is located on a second side of the longitudinal bisecting plane. In some embodiments, the support member 130 intersects the longitudinal bisecting plane at the transition from the first leg 108 to the ring 104. Thus, in some embodiments, the first leg 108 is attached to a portion of the ring 104 that is on the second side of the longitudinal bisecting plane. In some embodiments, the ring 104 intersects the longitudinal bisecting plane at the location where the legs 108, 110 pass through the aperture 132. In some embodiments, the support member 130 again intersects the longitudinal bisecting plane at the transition from the ring 104 to the second leg 110. Thus, in some embodiments, the second leg 110 is attached to a portion of the ring 104 that is on the first side of the longitudinal bisecting plane.

[0047] In some embodiments, one end of the filter 106 material is attached to the ring 104, and the aperture 122 includes an inlet into the cavity of the filter 106. In some embodiments, the guide wire 102 passes through the interior of the aperture 122 and extends within the cavity of the filter 106. In some embodiments, the distal end of the filter 106 is attached to the guide wire 102.

[0048] In some embodiments, the support member 120 is attached to the guide wire 102 only at the joint 114. Thus, in some embodiments, the legs 108, 110 are attached to the guide wire 102 only at their proximal ends, and the ring 104 is not specifically attached to the guide wire 102. This configuration allows the ring 104 to have greater flexibility to adjust its size in response to a smaller blood vessel, as the ring 104 is able to move away from the guide wire 102. Additionally, the legs 108, 110 are able to pivot at the joint 114, allowing the distal ends of the legs 108, 110 to move away from the guide wire 102 together with the ring 104 and also allowing the distal ends of the legs 108, 110 to expand laterally when the size of the ring 104 is compressed.

[0049] Figure 7A and 7B Other views showing embodiments of the embolic protection device located in lumens 122 of different sizes. Figure 7A Shows a larger lumen 122, while Figure 7B Shows a smaller lumen. Figure 7B The ring 104 in limits a smaller aperture 132 as the size of the ring 104 decreases due to a compressive force (such as a compressive force applied by the wall of the lumen 122). As the size of the aperture 132 decreases, the location where the support member 130 crosses itself can change, and the legs 108, 110 can expand laterally, moving away from the guide wire 102. In some embodiments, as the size of the aperture 132 decreases, the filter 106 material can be folded and overlapped 134. Figure 7A and 7BAn embodiment of the catheter 136 is also shown.

[0050] In some embodiments, the embolic protection device 100 is capable of assuming a number of different deployment orientations, such as in response to an external force applied by blood vessels 122 of various sizes. In some embodiments, the embolic protection device 100 includes a first orientation (such as as shown in Figure 6A and 7A ), and a second orientation (such as as shown in Figure 6B and 7B ). In some embodiments, the cross-sectional area of the aperture 132 defined by the ring 104 is larger in the first orientation and smaller in the second orientation. In some embodiments, the angle between the legs 108, 110, measured, for example, from the connector 114, is larger in the second orientation than in the first orientation. In some embodiments, the spacing between the proximal ends of the legs 108, 110 is larger in the second orientation than in the first orientation. In some embodiments, the angle between a portion of the guide wire 102 located between the legs 108, 110 and the cross-section of the aperture 132 forms an oblique angle. In some embodiments, the angle between the guide wire 102 and the cross-section of the aperture 132 is greater in the second orientation than in the first orientation. In some embodiments, when the support member 130 deforms in response to an external force, the ring 104 and the legs 108, 110 pivot together away from the guide wire 102 at the connector 114. Thus, in some embodiments, the distal ends of the legs 108, 110 and a portion of the ring 104 are farther from the guide wire 102 in the second orientation than in the first orientation. In some embodiments, the filter 106 generally includes a single layer of material at the connection body connected to the ring 104 in the first orientation. In some embodiments, a portion of the filter 106 is foldable and forms an overlapping portion 134 in the second orientation. In some embodiments, the overlapping portion 134 is located near the ring 104. In some embodiments, the overlapping portion 134 is located at a position opposite the legs 108, 110.

[0051] U.S. Patent Application No. 17 / 556,967, published as US2022 / 0192689, the entire content of which is incorporated herein by reference.

[0052] In many embodiments, some portions of wire 102 have different diameters. In some embodiments, the diameter of the proximal portion of wire 102 is greater than the diameter of the wire extending with filter 106. Many commercially available devices for treating peripheral vascular diseases are compatible with wires up to 0.035 inches in diameter. Many commercially available devices for treating coronary vascular diseases are compatible with wires up to 0.014 inches in diameter. While larger diameter wires provide more support than smaller diameter wires, smaller diameter wires are generally more flexible and can more easily traverse tortuous anatomy. In some embodiments of the present invention, the embolic protection device 100 is located within the delivery catheter. For delivery, the combined delivery catheter and embolic protection device 100 are advanced together through the lumen and / or across the lesion. Traversing the lesion (especially in tortuous anatomy) requires balancing a number of characteristics, including pushability and flexibility. Thus, while smaller diameter devices are generally more flexible, larger diameter and / or stiffer devices will have greater pushability. The diameter of the delivery catheter depends on the minimum inner diameter required to accommodate the collapsed embolic protection device 100 including wire 102. In the portion of the filter extending from 114 to the distal end of filter 106, the effective diameter will include the diameter of the guide wire 102 plus the space required for legs 108 and 110 and the collapsed proximal ring 104 and filter 106. In some embodiments, the competing requirements of a large diameter wire for support and a small diameter profile for the delivery catheter can be balanced by using a wire such that the diameter of the proximal portion of the guide wire 102 (proximal end of 114) is greater than 0.030 inches, and the diameter of the portion of wire 102 extending from 114 to the distal end of filter 106 is less than 0.030 inches. In other embodiments, the diameter of the portion of wire 102 extending from 114 to the distal end of filter 106 is less than 0.025 inches or less than 0.020 inches. In some embodiments, the diameter of the portion of wire 102 distal to the distal end of filter 106 will be approximately equal to the diameter of the wire near 114. In some embodiments, the diameter of the portion of wire 102 distal to the distal end of filter 106 will be between about 0.010 and 0.025 inches. In some embodiments, the diameter of the portion of wire 102 distal to the distal end of filter 106 will include three sub-portions. The wire diameter of the proximal sub-portion will be greater than 0.30 inches, 0.035 inches in some embodiments. The wire diameter of the middle sub-portion will be between 0.015 and 0.03 inches or between 0.02 and 0.03 inches, 0.18 inches in some embodiments. The wire diameter of the distal sub-portion will be less than 0.02 inches or less than 0.015 inches, 0.014 inches in some embodiments.

[0053] In some embodiments, the delivery catheter embolic protection device 100 is advanced in a body lumen that may include an obstruction. In some embodiments, the portion of the wire 102 that extends distally of the filter 106 is distal to the distal end of the delivery catheter and wraps proximally. This wrapped wire may assist the doctor / operator in advancing the delivery catheter and embolic protection device through the lumen and / or lesion. When in the proper position, the delivery catheter may be retracted such that the expandable ring 104 and the porous filter 106 expand. The expandable ring 104 expands to contact the lumen wall and the porous filter 106 opens. The diameter of the expandable ring 104 is equal to or slightly larger than the diameter of the target lumen such that it contacts the inner surface of the lumen. In some examples, the expandable ring 104 is radiopaque so that the doctor / operator can ensure that it has expanded to contact the lumen wall. The expandable ring 104 can be made more radiopaque by using crimping or platinum, tungsten, or gold markers applied to the ring. After the filter 100 is properly positioned in the lumen, the delivery catheter can be removed from the body. At this time, the doctor / user can use an interventional device, such as a balloon catheter, drug-coated balloon catheter, stent delivery catheter, drug-coated stent delivery catheter, thrombectomy catheter, IVUS, other imaging catheter, or atherectomy catheter. When the balloon catheter or other interventional device is advanced through the lumen and / or lesion and expanded, or when used with other interventional devices, embolic particles can be released. The embolic particles can be thromboembolic (thrombus particles) or plaque particles. By having the expandable ring 104 and the porous filter 104 in a delivery configuration, the embolic protection device 100 is capable of capturing emboli and thus protecting the downstream lumen.

[0054] After the intervention is completed, the doctor / user will retract the interventional device, leaving the embolic protection device 100 in place. Then, the retrieval catheter can be advanced along the wire 102 and the filter 100 to capture the filter 100 and remove it from the lumen.

[0055] In some of the illustrated embodiments, the wire 102 extends with the filter outside of the porous filter 106. In these embodiments, the porous filter is attached to the expandable ring, and in some embodiments, the distal end of the porous filter is attached to the wire. This attachment point may include a radiopaque marker. In other embodiments, the wire 102 extends into the filter 104. In these embodiments, the porous filter 106 is attached to the expandable ring 104, and in some embodiments, the distal end of the porous filter is attached to the wire, preferably at the point where the wire exits the porous filter. This attachment point may include a radiopaque marker. For all of the embodiments shown herein, both configurations are applicable.

[0056] In some embodiments, a single size of embolic protection device is used for lumens of various diameters. For example, an embolic protection device with an expandable ring diameter of 12 millimeters can be used for lumens with diameters of 5 to 10 millimeters.

[0057] The length of the collapsible filter described herein can be from 2 cm to 7 cm. In some embodiments, the length of the collapsible filter can be from 2.5 cm to 5 cm. In some embodiments, the length that the wire 102 extends distally from the distal end of the filter 106 can be from 10 cm to 15 cm. In embodiments having a segmented distal tip, the length of each segment of the tip can be from 2 cm to 5 cm.

[0058] The devices described herein can be used for two different clinical indications. In many cases, but not all, both indications may be present. First, the device will be used as a peripheral embolization protection device. Many endovascular procedures carry an unacceptable risk of peripheral embolization, and many peripheral procedures are performed in the presence of existing thrombi. The device will protect the patient from the risks of atherosclerotic embolization and thromboembolization. Deploying an embolization protection basket distal to the lesion / thrombus will mitigate the risk of embolization complications during endovascular procedures. Its design and size can be customized according to peripheral arteries, including the aorta, iliac arteries, femoral arteries, popliteal arteries, common carotid arteries, subclavian arteries, and brachiocephalic trunks. Its design and size can also be customized according to veins. Second, the design of the device will make it easier for the operator to cross chronic total occlusions (CTOs) of the above arteries. In some cases, endovascular treatment of chronic total occlusions carries an unacceptable risk of embolization complications, and the devices described herein will allow the operator to treat CTOs in a safer, more intuitive, and faster manner. For example: The presence of an occluded peripheral graft and occlusion caused by old thrombi will always be associated with a very high risk of embolization complications. The devices described herein will significantly reduce this risk.

[0059] The devices of the present disclosure can be used in a variety of clinical situations. Lesions (including thrombotic occlusions) in the following items can be treated using the devices described herein: including the superficial femoral artery (SFA), common femoral artery, popliteal artery, iliac artery, iliac artery bypass, or fem-pop bypass. Vessels extending from the aortic arch, such as brachiocephalic arteries, left and right common carotid arteries, brachiocephalic trunk, brachial branches, and left subclavian artery, can be treated using these devices. The devices described herein can also be used in the venous system and can be used to treat lesions in the following items: iliac veins, femoral veins, popliteal veins, brachial veins, subclavian veins, axillary veins, innominate veins, and inferior vena cava and superior vena cava. According to clinical requirements, radial artery, brachial artery, subclavian artery, pedal artery, proximal tibial artery, or femoral artery access can be used.

[0060] Although many examples herein show and describe devices and methods used and performed in the vascular system, these devices and methods are also applicable to non-vascular lumens.

[0061] The retrieval catheter, delivery catheter, and embolic protection device will be made of materials known in the art. The delivery catheter and retrieval catheter may have a multi-layer or single-layer construction. In a multi-layer construction, the catheter may have a polymer inner layer surrounded by a support structure such as a metal braid, which is then surrounded by an outer polymer layer. Either catheter may have a consistent flexibility along the length of the catheter or may have increased flexibility at the distal end. Alternatively, the catheter may be made by single-flow or multi-flow extrusion, with or without an internal support structure. When one or both of the delivery catheter and retrieval catheter have one or more marker bands, the marker bands may be formed of any radiopaque material and may be in the form of a ring attached to the inner or outer surface, embedded in the inner or outer surface such that they are flush with the surface, embedded within the wall structure of the catheter, or be a radiopaque agent mixed with the plastic of the catheter. One or both of the delivery catheter and retrieval catheter may have a distal tip that is softer and / or more flexible than the catheter body. The embolic protection filter wire may be composed of a superelastic material, nitinol, stainless steel, cobalt-chromium-nickel-molybdenum-iron alloy, or cobalt-chromium alloy, or a combination thereof. In embodiments where the diameter of the distal portion of the basket and / or wire is less than the proximal portion, the smaller diameter may be achieved by grinding or milling of the wire or by attaching a smaller diameter wire to the distal end of a larger diameter wire. The expandable ring may be composed of a superelastic material, nitinol, stainless steel, cobalt-chromium-nickel-molybdenum-iron alloy, or cobalt-chromium alloy, or a combination thereof.

[0062] The porous filter 106 can be made of a variety of different materials, such as, but not limited to, interwoven or woven plastic or metal mesh, perforated polymer membranes, shape memory materials or meshes, combinations thereof, or other materials capable of capturing substances in flowing blood while allowing blood to flow through the pores of the material. In some embodiments, the porous filter includes expanded polytetrafluoroethylene (ePTFE), polyurethane, polyolefin elastomer, polyamide, nylon, polyether, polyamide block ether (PEBAX), polyester, and / or copolyester. In some embodiments, the thickness of the filter material is 0.001 inches (25 microns), and the material has a Shore A hardness of 85A. In some embodiments, the thickness of the filter material is 0.0017 inches and the Shore A hardness is 80. In some embodiments, the porous filter can be interwoven or woven into a mesh and can be made of polyester, polyamide, polyurethane, nitinol, or stainless steel wire. The porous filter can have pores of various different sizes, ranging from about 50 microns to about 200 microns, from about 60 microns to about 180 microns, or from about 75 microns to about 150 microns. For some applications, the pore size can be as high as 250 microns. The pores can have various different configurations, can be circular, oval, polygonal, combinations thereof, and the porous filter can include pores of different sizes and configurations. In practice, the pore size can vary as needed, as long as the pore size is such that the pores do not affect the flow of blood through the filter and can collect emboli that may have an adverse effect on downstream blood vessels. The porous filter can be coated with a hydrophilic coating, a heparinized coating, PTFE, silicone, combinations thereof, or other coatings. In some embodiments, the porous filter can be attached to the expandable ring by dip coating or winding around the ring and then heating or by sealing with an adhesive.

[0063] In some embodiments, the retrieval catheter has a length of 120 to 140 cm, an outer diameter between 0.07 and 0.09 inches, preferably about 0.08 inches, and an inner diameter between 0.065 and 0.085 inches, preferably about 0.07 inches. In some embodiments, the delivery catheter has a length of about 260 to 300 cm, an outer diameter between 0.06 and 0.08 inches, preferably 0.06 inches, and an inner diameter between 0.04 and 0.075 inches, preferably 0.055 inches. In other embodiments, the delivery catheter has a length of about 100 to 150 cm. In some embodiments, the catheter itself has a length of 120 to 140 cm and the proximal wire has a length of 120 to 160 cm. In some embodiments, the embolic protection device has a length of 260 to 300 cm. In some embodiments, the wire has a diameter of 0.035 inches. In embodiments where the basket and / or distal portion have a smaller diameter, their diameter can be 0.018 inches or 0.014 inches. In embodiments where the delivery catheter is angled, the angled portion 114 can be located 1 cm from the distal tip. In embodiments where the delivery catheter has one or more radiopaque markers, the distal marker can be located 1 cm from the distal end, while the proximal band (if any) will be located 5 cm from the distal end. In embodiments where the retrieval catheter is angled, the angled portion 114 can be located 2 cm from the distal tip. In embodiments where the retrieval catheter has one or more radiopaque markers, the distal marker can be located 2 cm from the distal end. In embodiments where the distal portion of the retrieval and / or delivery catheter is angled, they can be angled between 10 and 30 degrees with respect to the longitudinal axis of the catheter. In some embodiments, the two legs and / or the expandable frame are made of nitinol wire. In some embodiments, radiopaque markers are provided on the wire of the two legs and / or the expandable frame. In some embodiments, the wire of the two legs and / or the expandable frame can be a core wire or a wire formed of two materials, platinum and nitinol.

[0064] In some embodiments, a method of protecting a blood vessel includes providing a distal protection device that includes a wire with a collapsible basket located near the distal end of the wire. The collapsible basket includes: an expandable ring having two legs that are connected to the wire at a connection body; and a porous filter that is attached to the ring at one end. In some embodiments, the two legs extend along the wire between the collapsible basket and the connection body. In some embodiments, the distal protection device is located within a delivery catheter. The delivery catheter and the distal protection device are advanced through the lumen to a position downstream of the treatment area. The delivery catheter is withdrawn to allow the expandable ring to expand to contact the interior of the lumen.

[0065] In some embodiments, a method of approaching a lesion within an occluded lumen includes providing an embolic protection device disposed within a delivery catheter. In some embodiments, the embolic protection device includes a wire, two legs, and an expandable ring having a porous filter. In some embodiments, the two legs connect the expandable ring to the wire at a connector body, and the two legs extend along the wire between a collapsible basket and the connector body. In some embodiments, a distal end of the wire extends beyond a distal end of the delivery catheter. In some embodiments, the distal end of the wire is flexible, allowing the wire to wrap back toward a proximal end of the delivery catheter. With the distal end of the wire looped around the distal end of the delivery catheter, the delivery catheter and the embolic protection device are advanced through a body lumen to a lesion site by applying a forward force to the delivery catheter or the wire until the distal end of the delivery catheter is distal to the lesion. The delivery catheter is retracted from above the collapsible basket, causing the collapsible basket to assume an open state.

[0066] Although specific embodiments have been illustrated and described herein, those of ordinary skill in the art will recognize that arrangements calculated to achieve the same results may be substituted for the specific embodiments shown. For example, while the present disclosure may display a system or method using one example of a distal protection device, any distal protection device may be used, including the devices disclosed herein. The present disclosure is intended to cover variations or modifications of one or more embodiments of the present disclosure. It should be understood that the foregoing description has been presented in an illustrative manner, and not a restrictive one. Combinations of the above-described embodiments and other embodiments not specifically described herein will be apparent to those of skill in the art upon review of the foregoing description. The scope of one or more embodiments of the present disclosure includes other applications using the above-described structures and processes. Accordingly, the scope of one or more embodiments of the present disclosure should be determined with reference to the appended claims and the full scope of equivalents to such claims.

[0067] In the foregoing detailed description, for purposes of simplifying the disclosure, some features are combined in one embodiment. This method of the present disclosure should not be construed as reflecting an intention that the disclosed embodiments of the present disclosure must use more features than are expressly recited in each claim. Rather, as the following claims reflect, the inventive subject matter lies in less than all features of a single disclosed embodiment. Accordingly, the following claims are hereby incorporated into the detailed description, with each claim standing on its own as a separate embodiment.

Claims

1. An embolic protection device, comprising: a wire with a collapsible basket, the collapsible basket being located near the distal end of the wire; the collapsible basket includes an expandable ring having two legs and a porous filter attached to the ring at one end, the two legs being connected to the wire at a connection body; wherein the two legs extend along the wire between the collapsible basket and the connection body.

2. The embolic protection device according to claim 1, wherein the expandable ring comprises a material that enables the expandable ring to expand from a delivery configuration to an open configuration.

3. The embolic protection device according to claim 1, wherein the two legs extend proximally from the expandable ring.

4. The embolic protection device according to claim 3, wherein a first leg of the two legs is connected to the wire on a first side of the wire, a second leg of the two legs is connected to the wire on a second side of the wire, and wherein the first leg is connected to a portion of the expandable ring that is on the second side of the wire, and the second leg is connected to a portion of the expandable ring that is on the first side of the wire.

5. The embolic protection device according to claim 1, wherein a first leg of the two legs crosses a second leg of the two legs between the connection body of the two legs to the wire and the expandable basket.

6. The embolic protection device according to claim 1, wherein the expandable ring comprises a preferential bending region.

7. The embolic protection device according to claim 6, wherein the preferential bending region is generally located on a side of the expandable ring opposite to the two legs.

8. The embolic protection device according to claim 6, wherein the preferential bending region comprises a U-shaped, V-shaped or omega-shaped region.

9. The embolic protection device according to claim 1, wherein when expanded in an unconstrained manner, the expandable ring has a non-circular shape.

10. The embolic protection device according to claim 9, wherein when the expandable ring is positioned with the wire at the bottom of the ring, the vertical diameter of the expandable ring is smaller than the horizontal diameter.

11. The embolic protection device according to claim 10, wherein the horizontal diameter is more than about 5% larger than the vertical diameter.

12. The embolic protection device according to claim 1, wherein the porous filter comprises pores, and the pores are arranged in a staggered pattern.

13. An embolic protection device, comprising: a wire with a collapsible basket, the collapsible basket being located near the distal end of the wire; the collapsible basket includes an expandable ring connected to the wire, and a porous filter attached to the ring at one end; and wherein the expandable ring has a non-circular shape when in an unconstrained and expanded position.

14. The device according to claim 13, further comprising: two legs, wherein one end of each of the two legs is connected to the ring, and the other end of the two legs is connected to the wire.

15. The device according to claim 13, wherein the expandable ring comprises a preferential bending region.

16. The device according to claim 15, wherein the preferred bending region is generally located on a side of the expandable ring opposite to the wire.

17. An embolic protection device, comprising: a guide wire; a support member including a first leg, a ring, and a second leg, the first leg being attached to the guide wire at a junction, the first leg extending distally of the junction, the second leg being attached to the guide wire at the junction, the second leg extending distally of the junction, the ring extending distally of the first leg and the second leg, the ring defining an aperture, and the guide wire extending through the aperture; and a porous filter attached to the ring.

18. The embolic protection device according to claim 17, wherein the first leg is located on a first side of the guide wire and is attached to a portion of the ring located on a second side of the guide wire, and the second leg is located on the second side of the guide wire and is attached to a portion of the ring located on the first side of the guide wire.

19. The embolic protection device according to claim 17, comprising a first orientation and a second orientation, wherein the aperture is smaller in the second orientation than in the first orientation, and the distance between the first leg and the second leg is greater in the second orientation than in the first orientation.

20. The embolic protection device according to claim 17, wherein the ring includes a preferred bending region.

Images