Devices, systems and methods for removing vascular obstructions - Patents.com

Abstract

An obstruction removal device, system, and / or method is provided. In one embodiment, a removal tool is disposed at a distal end of a delivery tool and is configured to at least partially separate an obstruction from an inner surface of a vascular system. An expandable member is also coupled to the delivery tool. The expandable member has a proximal end that is free or slidably coupled to the delivery tool. The proximal end of the expandable member is configured to evertate or slide toward the distal end of the expandable member, such that the expandable member surrounds the obstruction and at least a portion of the removal tool, thereby trapping the obstruction between the expandable member and the removal tool when the delivery tool is retracted from the vascular system to remove the removal tool and the obstruction from the vascular system.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Application No. 62 / 789,584, entitled "APPARATUS, SYSTEM, AND METHOD FOR VASCULATURE OBSTRUCTION REMOVAL," filed January 8, 2019, the entire contents of which are incorporated herein by reference. This application also claims priority to U.S. Nonprovisional Application No. 16 / 736,279, entitled "APPARATUS, SYSTEM, AND METHOD FOR VASCULATURE OBSTRUCTION REMOVAL," filed January 7, 2020, the entire contents of which are incorporated herein by reference.

[0002] The present invention relates generally to medical devices, and more particularly to medical devices for removing vascular obstructions. [Background technology]

[0003] Obstruction removal systems / devices operate by containing the obstruction within the removal system components, but in some cases, the obstruction may become dislodged. Dislodgment of the obstruction significantly increases the risk of potential complications (e.g., stroke or heart attack). Therefore, it is desirable to safely secure the obstruction and remove it from the body. Summary of the Invention

[0004] The present invention discloses an obstruction removal system. In one or more embodiments, the obstruction removal system includes a guide catheter configured to be inserted into a vascular system, and a delivery tool having a distal end configured to be inserted into the guide catheter and positioned near an obstruction in the vascular system. The obstruction removal system further includes a removal tool positioned at the distal end of the delivery tool. The removal tool is configured to at least partially separate the obstruction from an inner surface of the vascular system. An expandable member is also coupled to the delivery tool. The expandable member has a proximal end that is free or slidably coupled to the delivery tool. The proximal end of the expandable member is configured to evert or slide toward its distal end, thereby causing the expandable member to surround the obstruction and at least a portion of the removal tool, such that the obstruction is captured between the expandable member and the removal tool when the delivery tool is retracted from the vascular system to remove the removal tool and the obstruction from the vascular system.

[0005] More generally, an occlusion removal device is disclosed. In one or more embodiments, the occlusion removal device comprises a removal tool disposed at a distal end of a delivery tool and configured to at least partially separate an occlusion from an inner surface of a vascular system. The occlusion removal device further comprises an expandable member coupled to the delivery tool. The expandable member has a proximal end that is free or slidably coupled to the delivery tool. The proximal end of the expandable member is configured to evert or slide toward the distal end of the expandable member, causing the expandable member to encircle the occlusion and at least a portion of the removal tool, such that the occlusion is captured between the expandable member and the removal tool when the delivery tool is retracted from the vascular system to remove the removal tool and the occlusion from the vascular system.

[0006] Also disclosed is a method for removing obstructions from the vascular system. In one or more embodiments, the method includes: inserting a guide catheter into the vascular system; positioning a distal end of the delivery tool in the vascular system adjacent the obstruction by passing the delivery tool through the guide catheter; removing at least a portion of the obstruction in the vascular system with a removal tool disposed at the distal end of the delivery tool and configured to at least partially separate the obstruction from an interior surface of the vascular system; encircling the occlusion and at least a portion of the removal tool with an expandable member coupled to the delivery tool, the expandable member having a proximal end that is free or slidably coupled to the delivery tool, the proximal end configured to evert or slide toward the distal end of the expandable member, such that the occlusion is trapped between the expandable member and the removal tool when the delivery tool is retracted from the vascular system to remove the removal tool and the occlusion from the vascular system.

[0007] The above summary of the present invention is merely provided as an introduction to specific embodiments and aspects that are fully described in the drawings. The above summary of the present invention should not be considered as describing essential features, nor should it be used to specify the scope of protection of each claim. In addition, it should be understood that the above summary of the present invention and the following specific embodiments are merely illustrative and explanatory, and do not necessarily limit the subject matter to be protected by the present application. [Brief description of the drawings]

[0008] The following detailed description will be given with reference to the drawings. The same reference numerals used in different examples in the specification and drawings may represent similar or identical items. Various embodiments and examples ("Examples") of the present disclosure are disclosed in the following detailed description and drawings. The drawings are not necessarily drawn to scale. In general, the operations of the disclosed steps may be performed in any order unless otherwise limited in the claims.

[0009] [Figure 1A] 1 is a cross-sectional side view of a guide catheter of an obstruction removal system positioned within the vascular system in accordance with one or more embodiments of the present invention.

[0010] [Figure 1B] FIG. 1 is a cross-sectional side view of an obstruction removal device of an obstruction removal system positioned through a guide catheter in accordance with one or more embodiments of the present invention, where the obstruction removal device comprises a removal tool and an expandable member attached to a delivery tool, the delivery tool being inserted through the guide catheter by an intermediate catheter.

[0011] [Figure 1C] FIG. 1 is a cross-sectional side view of an occlusion removal device of an occlusion removal system positioned within a vascular system in accordance with one or more embodiments of the present invention, wherein pulling back on the intermediate catheter (and / or pushing the delivery tool forward) to expose the occlusion removal device allows the removal tool to abut the occlusion and at least partially separate the occlusion from the inner surface of the vascular system.

[0012] [Figure 1D] FIG. 1 is a cross-sectional side view of an occlusion removal device of an occlusion removal system disposed within a vascular system in accordance with one or more embodiments of the present disclosure, wherein a proximal end of the expandable member slides toward a distal end of the expandable member and an intermediate portion of the expandable member folds over the distal end of the expandable member and over at least a portion of the removal tool, such that the occlusion material is trapped between the expandable member and the removal tool when the delivery tool is retracted from the vascular system to remove the removal tool and the occlusion material from the vascular system.

[0013] [Figure 1D-1]FIG. 1 is a cross-sectional side view of an occlusion removal device of an occlusion removal system disposed within a vascular system in accordance with one or more embodiments of the present disclosure, wherein a proximal end of the expandable member slides toward a distal end of the expandable member and an intermediate portion of the expandable member folds over the distal end of the expandable member and over at least a portion of the removal tool, such that the occlusion is captured between the expandable member and the removal tool when the delivery tool is pulled back from the vascular system to remove the removal tool and the occlusion from the vascular system, where friction between the expandable member and the inner surface of the vascular system causes the expandable member to invert and / or fold over itself.

[0014] [Figure 1D-2] FIG. 1 is a cross-sectional side view of an occlusion removal device of an occlusion removal system deployed within a vascular system in accordance with one or more embodiments of the present invention, where a proximal end of the expandable member slides toward a distal end of the expandable member and an intermediate portion of the expandable member folds over the distal end of the expandable member and over at least a portion of the removal tool such that the occlusion is trapped between the expandable member and the removal tool as the delivery tool is pulled back from the vascular system to remove the removal tool and the occlusion from the vascular system, and where an intermediate catheter is used to push the expandable member to invert and / or fold upon itself.

[0015] [Figure 1E] FIG. 1 is a cross-sectional side view of an occlusion removal device of an occlusion removal system deployed within a vascular system in accordance with one or more embodiments of the present disclosure, wherein an intermediate portion of the expandable member is folded over a distal end of the expandable member and at least a portion of the removal tool, such that occlusion material is trapped between the expandable member and the removal tool.

[0016] [Figure 1F] FIG. 1 is a cross-sectional side view of an obstruction removal device and intermediate catheter of an obstruction removal system in accordance with one or more embodiments of the present invention, where the obstruction removal device and intermediate catheter are being pulled back through the guide catheter to remove obstruction from the vascular system.

[0017] [Figure 2A] 1 is a cross-sectional side view of a guide catheter of an obstruction removal system positioned within the vascular system in accordance with one or more embodiments of the present invention.

[0018] [Figure 2B] FIG. 1 is a cross-sectional side view of an obstruction removal device of an obstruction removal system deployed through a guide catheter in accordance with one or more embodiments of the present invention, where the obstruction removal device includes a removal tool and an expandable member attached to a delivery tool, the delivery tool being inserted through the guide catheter by an intermediate catheter.

[0019] [Figure 2C] FIG. 1 is a cross-sectional side view of an occlusion removal device of an occlusion removal system positioned within a vascular system in accordance with one or more embodiments of the present invention, wherein pulling back on the intermediate catheter (and / or pushing the delivery tool forward) to expose the occlusion removal device allows the removal tool to abut the occlusion and at least partially separate the occlusion from the inner surface of the vascular system.

[0020] [Figure 2D] FIG. 1 is a cross-sectional side view of an occlusion material removal device of an occlusion material removal system disposed within a vascular system in accordance with one or more embodiments of the present disclosure, wherein the proximal end of the expandable member is everted to cover the distal end of the expandable member and at least a portion of the removal tool, such that the occlusion material is trapped between the expandable member and the removal tool when the delivery tool is retracted from the vascular system to remove the removal tool and the occlusion material from the vascular system.

[0021] [Figure 2E] FIG. 1 is a cross-sectional side view of an occlusion removal device of an occlusion removal system deployed within a vascular system in accordance with one or more embodiments of the present disclosure, wherein the proximal end of the expandable member is everted to cover the distal end of the expandable member and at least a portion of the removal tool, such that occlusion is trapped between the expandable member and the removal tool.

[0022] [Figure 2F] FIG. 1 is a cross-sectional side view of an obstruction removal device and intermediate catheter of an obstruction removal system in accordance with one or more embodiments of the present invention, where the obstruction removal device and intermediate catheter are being pulled back through the guide catheter to remove obstruction from the vascular system.

[0023] [Figure 3A] FIG. 1 is a cross-sectional side view of an obstruction removal device of an obstruction removal system according to one or more embodiments of the present invention, the obstruction removal system including a passive removal tool in a deployed (expanded) configuration.

[0024] [Figure 3B] FIG. 2 is a cross-sectional side view of an obstruction removal device of an obstruction removal system in a deployed (extended) configuration, the obstruction removal system including a passive removal tool reinforced by an internal frame, in accordance with one or more embodiments of the present invention.

[0025] [Figure 4A] FIG. 2 is a cross-sectional side view of an obstruction removal apparatus of an obstruction removal system including an active removal tool in an undeployed (folded) configuration in accordance with one or more embodiments of the present invention.

[0026] [Figure 4B] FIG. 1 is a cross-sectional side view of an obstruction removal apparatus of an obstruction removal system including an active removal tool in a deployed (expanded) configuration in accordance with one or more embodiments of the present invention.

[0027] [Figure 4C] FIG. 2 is a cross-sectional side view of an obstruction removal device of an obstruction removal system in a deployed (extended) configuration, the obstruction removal system including an active removal tool reinforced by an internal frame, in accordance with one or more embodiments of the present invention.

[0028] [Figure 5A]FIG. 2 is a cross-sectional side view of an obstruction removal apparatus of an obstruction removal system including an active removal tool in an undeployed (folded) configuration in accordance with one or more embodiments of the present invention.

[0029] [Figure 5B] FIG. 1 is a cross-sectional side view of an obstruction removal apparatus of an obstruction removal system including an active removal tool in a deployed (expanded) configuration in accordance with one or more embodiments of the present invention.

[0030] [Figure 5C] FIG. 2 is a cross-sectional side view of an obstruction removal device of an obstruction removal system in a deployed (extended) configuration, the obstruction removal system including an active removal tool reinforced by an internal frame, in accordance with one or more embodiments of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] Reference will now be made in detail to the subject matter illustrated in the drawings. Referring generally to Figures 1A-5C, an obstruction removal system is shown, and in particular, an obstruction removal system configured to selectively place a removal tool having an expandable member in the vascular system to reduce risks associated with removing the obstruction. The expandable member is used to prevent the obstruction from breaking away from the removal tool and migrating to areas of higher potential risk (e.g., causing a total occlusion, occluding a portion of the critical vascular system, etc.). In this case, a physician may determine whether the obstruction is high risk and then selectively use the removal tool having the expandable member.

[0032] 1A-1F illustrate one or more embodiments of an obstruction removal system 100. As shown in FIG. 1A, the obstruction removal system 100 includes a guide catheter 104 (e.g., any suitable guide catheter, suction catheter, or any other suitable tube) configured to be inserted into a vascular system 102 to a location near an obstruction 101. As shown in FIG. 1B, the obstruction removal system 100 further includes an obstruction removal device having a removal tool 110 and an expandable member 112 configured to be inserted through the guide catheter 104. For example, the removal tool 110 and the expandable member 112 may be coupled to or formed at (or near) a distal end of a delivery tool 108 configured to be inserted through the guide catheter 104. In one embodiment, the delivery tool 108 may be a guidewire or tube. In this case, the removal tool 110 may be fixed to the distal end of the guidewire or tube, and the expandable member 112 may be fixed at a location near the removal tool 110 or slidably coupled to the guidewire or tube.

[0033] In one embodiment, the obstruction removal device (i.e., the removal tool 110 and expandable member 112 of the delivery tool 108) may be at least partially contained within the intermediate catheter 106 (e.g., any suitable intermediate catheter, microcatheter, or any other suitable tube) during the insertion process. The intermediate catheter 106 is used to contain the removal tool 110 and expandable member 112 and prevent them from expanding within the guide catheter 104. This may provide one or more advantages, including, but not limited to, reducing friction between the removal tool 110 / expandable member 112 and the guide catheter 104, allowing the removal tool 110 and expandable member 112 to be inserted through a distal opening in the guide catheter 104, and preventing the removal tool 110 / expandable member 112 from engaging the obstruction 101 prematurely.

[0034] 1B shows the obstruction removal device positioned near the obstruction 101 in the vascular system 102. A delivery tool 108 (e.g., a guidewire and / or tube) is configured to be inserted into a guide catheter 104 and positioned near the obstruction 101 in the vascular system 102. For example, a delivery tool 108 having a removal tool 110 and an expandable member 112 attached to its end may be inserted through the guide catheter 104 by an intermediate catheter 106, which contains / encloses the removal tool 110 and the expandable member 112 during the insertion process.

[0035] 1C , the intermediate catheter 106 may be configured to expose the removal tool 110 and expandable member 112 therefrom, allowing the removal tool 110 to abut against the occlusion 101 in the vascular system 102. For example, when a desired location within the vascular system 102 is reached, the intermediate catheter 106 may be pulled back (and / or the delivery tool 108 may be pushed forward relative to the intermediate catheter 106) to expose the removal tool 110 and expandable member 112, allowing the removal tool 110 to abut against the occlusion 101.

[0036] The removal tool 110 is configured to at least partially separate the obstruction 101 from the inner surface (e.g., a vessel wall) of the vasculature 102. In one embodiment, the removal tool 110 has a cone- or umbrella-shaped portion (e.g., a cone-shaped and / or umbrella-shaped meshwork or structure) configured to at least partially surround the obstruction 101. In other embodiments, the removal tool 110 has a differently shaped meshwork or mesh (e.g., a semicircular or cylindrical structure, etc.) configured to at least partially surround the obstruction 101.

[0037] In embodiments in which the delivery tool 108 includes a guidewire disposed within a tube, a distal end of the removal tool 110 may be attached to the guidewire and another (middle) portion of the removal tool may be attached to the tube, such that the removal tool 110 can be expanded and contracted like an umbrella by moving the guidewire independently of (e.g., relative to) the tube. Additionally or alternatively, the removal tool 110 may be formed of a shape memory alloy and / or a superelastic alloy (e.g., Nitinol) such that the removal tool 110 can automatically expand upon exposure. For example, the removal tool 110 may be directed through the occlusion 101 and then pulled back upon exposure to scrape / dig out the occlusion 101 from the inner surface of the vasculature 102.

[0038] The expandable member 112 has a distal end 114 that is fixedly or slidably coupled to the delivery tool 108 and a proximal end 116 that is slidably coupled to the delivery tool 108. The expandable member 112 may be positioned such that the distal end 114 is located between the removal tool 110 and the proximal end 116 during the deployment process.

[0039] 1D , when the delivery tool 108 is retracted (e.g., back into the guide catheter 104 and / or intermediate catheter 106), the proximal end 116 of the expandable member 112 may be configured to slide toward the distal end 114 of the expandable member 112, thereby causing the expandable member 112 to surround the occlusion material 101 and at least a portion of the removal tool 110 and capture the occlusion material 101 between the expandable member 112 and the removal tool 110. In one embodiment, when the proximal end 116 of the expandable member 112 is slid toward the distal end 114 of the expandable member 112 by retracting the delivery tool 108 from the vasculature 102 to remove the removal tool 110 and the occlusion material 101 from the vasculature 102, the intermediate portion 118 of the expandable member 112 is configured to fold over the distal end 114 of the expandable member 112 and at least a portion of the removal tool 110. This causes the occlusion material 101 to be trapped between the expandable member 112 and the removal tool 110. For example, when the delivery tool 108 is retracted by the guide catheter 104 and / or intermediate catheter 106, friction between the intermediate portion 118 of the expandable member 112 and the inner surface of the vasculature 102 (e.g., as shown in FIG. 1D-1 ), the guide catheter 104, or the intermediate catheter 106 may cause the intermediate portion of the expandable member 112 to fold over the removal tool 110, thereby trapping the occlusion material 101 between the expandable member 112 and the removal tool 110. Additionally or alternatively, when the delivery tool 108 is retracted by the guide catheter 104 and / or intermediate catheter 106, resistance due to fluid in the vasculature 102 may cause the intermediate portion of the expandable member 112 to fold over the removal tool 110, thereby trapping the occlusion material 101 between the expandable member 112 and the removal tool 110. Also, as shown in FIG. 1D-2, in some embodiments, the intermediate catheter 106 (or guide catheter 104) is used to push the expandable member 112 to invert and / or fold upon itself.

[0040] 1E illustrates the occlusion material 101 being trapped between the expandable member 112 and the removal tool 110 as the delivery tool 108 is retracted from the vascular system 102 to remove the removal tool 110 and the occlusion material 101 from the vascular system 102. For example, the delivery tool 108 can be retracted into the guide catheter 104 and / or intermediate catheter 106, thereby removing the occlusion material 101 trapped between the expandable member 112 and the removal tool 110 from the vascular system 102.

[0041] As shown in FIG 1F, the intermediate catheter 106, including the delivery tool 108 and the occlusion material 101 trapped between the expandable member 112 and the removal tool 110, can be pulled back through the guide catheter 104, thereby removing the occlusion material 101 from the vascular system 102. As shown in FIG 1F, the delivery tool 108 with the occlusion material removal device (including the removal tool 110 and the expandable member 112) and the occlusion material 101 can be pulled back by the intermediate catheter 106. Alternatively, the delivery tool 108 with the occlusion material 101 trapped between the expandable member 112 and the removal tool 110 may be pulled back through the guide catheter 104 directly (without the use of the intermediate catheter 106).

[0042] 2A-2F show another embodiment of the obstruction removal system 100 in which an expandable member 112 has a distal end 114 that is coupled to the delivery tool 108 and a proximal end 116 that is configured to be freely movable. For example, the expandable member 112 may include a cone / umbrella mesh or mesh structure having one end that is fixedly or slidably coupled to the delivery tool 108 and the other end that is a free / open end.

[0043] 2B and 2C, when the occlusion removal apparatus (i.e., the removal tool 110 and the expandable member 112 in the delivery tool 108) is guided through the vascular system 102 to reach the occlusion 101, the expandable member 112 may be oriented such that its proximal end 116 is away from the removal tool 110. Then, as shown in FIG. 2D, the proximal end 116 of the expandable member 112 may be configured to flip toward the distal end 114 of the expandable member 112 upon retraction of the delivery tool 108 (e.g., retraction into the guide catheter 104 and / or intermediate catheter 106), thereby causing the expandable member 112 to surround at least a portion of the occlusion 101 and the removal tool 110, trapping the occlusion 101 between the expandable member 112 and the removal tool 110. In one embodiment, the proximal end 116 of the expandable member 112 is configured to evert over and cover the distal end 114 of the expandable member 112 and at least a portion of the removal tool 110 when the delivery tool 108 is retracted from the vascular system 102 to remove the removal tool 110 and the occlusion material 101 from the vascular system 102. For example, when the delivery tool 108 is retracted through the guide catheter 104 and / or intermediate catheter 106, friction generated between the proximal end (i.e., free end) 116 of the expandable member 112 and the inner surface of the vascular system 102, the guide catheter 104, or the intermediate catheter 106 may cause the expandable member 112 to evert and cover the removal tool 110, such that the occlusion material 101 becomes trapped between the expandable member 112 and the removal tool 110. Additionally or alternatively, when the delivery tool 108 is pulled back by the guide catheter 104 and / or intermediate catheter 106, resistance from the fluid in the vascular system 102 allows the expandable member 112 to invert and cover the removal tool 110, trapping the occlusion material 101 between the expandable member 112 and the removal tool 110.

[0044] 2E illustrates the occlusion material 101 trapped between the expandable member 112 and the removal tool 110 as the delivery tool 108 is retracted from the vascular system 102 to remove the removal tool 110 and the occlusion material 101 from the vascular system 102. For example, the delivery tool 108 can be retracted into the guide catheter 104 and / or intermediate catheter 106 to remove the occlusion material 101 trapped between the expandable member 112 and the removal tool 110 from the vascular system 102.

[0045] As shown in FIGURE 2F, the intermediate catheter 106, containing the delivery tool 108 and the occlusion material 101 trapped between the expandable member 112 and the removal tool 110, can be pulled back through the guide catheter 104 to remove the occlusion material 101 from the vascular system 102. As shown in FIGURE 2F, the delivery tool 108 with the occlusion material removal device (including the removal tool 110 and the expandable member 112) and the occlusion material 101 can be pulled back by the intermediate catheter 106. Alternatively, the delivery tool 108 with the occlusion material 101 trapped between the expandable member 112 and the removal tool 110 can be pulled back through the guide catheter 104 directly (without the use of the intermediate catheter 106).

[0046] Also shown in Figures 3A-5C are various embodiments of removal tool 110. The embodiments of removal tool 110 shown in Figures 3A-5C may be used with any of the embodiments of obstruction removal system 100 shown in Figures 1A-2F or described herein.

[0047] In one embodiment, as shown in Figures 3A and 3B, the obstruction removal device may include a passive removal tool 110. In this case, the removal tool 110 may be configured to expand when positioned (e.g., exposed) away from the intermediate catheter 106. The removal tool 110 may have a distal end 109 (e.g., a tip coil) that is fixed to a distal end of the delivery tool 108 (e.g., a delivery tube or wire) and a proximal end 111 that is fixedly or slidably coupled to another portion of the delivery tool 108, thereby confining the obstruction attachment region 120 of the delivery tool 108 between the proximal end 111 of the removal tool 110 and the distal end 114 of the expandable member 112. In some embodiments, the end of the removal tool 110 and / or the expandable member 112 may include a marker band that is coupled to the delivery tool 108.

[0048] 4A-4C show an embodiment of an occlusion removal device that includes an active removal tool 110, where the removal tool 110 can be selectively expanded or collapsed. For example, the removal tool 110 can be expanded or contracted by driving both portions of the delivery tool 108 (e.g., the delivery wire 108A and the delivery tube 108B) relative to one another. The removal tool 110 can have a distal end 109 (e.g., a terminal coil) and a proximal end 111, where the distal end 109 is secured to the distal end of the delivery wire 108A and the proximal end 111 is secured to the distal end of the delivery tube 108B, either directly or via an occlusion attachment region 120 between the distal end 111 and the distal end 114 of the expandable member 112 (as shown in the figures).

[0049] In one embodiment, the expandable member 112 can be coupled to the delivery tube 108B to define an occlusion attachment region 120 between the proximal end 111 of the removal tool 110 and the distal end 114 of the expandable member 112. The occlusion attachment region 120 can include a wire mesh portion connecting the removal tool 110 and the expandable member 112. In some embodiments, the expandable member 112 and the removal tool 110 can each be part of a continuous wire mesh structure.

[0050] The ends of the removal tool 110 and / or the expandable member 112 may include marker bands that are coupled to corresponding portions of the delivery wire 108A and delivery tube 108B. As shown in Figures 4A and 4B, respectively, the removal tool 110 can be contracted by pushing the delivery wire 108A through the delivery tube 108B (or pulling the delivery tube 108B away from the distal end of the delivery wire 108A) and expanded by pulling the delivery wire 108A through the delivery tube 108B (or pushing the delivery tube 108B towards the distal end of the delivery wire 108A).

[0051] 5A-5C show one embodiment of an occlusion removal device including an active removal tool 110 and an active expandable member 112. In this case, the removal tool 110 and the expandable member 112 can be selectively expanded and contracted. For example, the removal tool 110 can be expanded and contracted by driving both portions of the delivery tool 108 (e.g., the delivery wire 108A and the delivery tube 108B) relative to one another. The removal tool 110 can have a distal end 109 (e.g., a terminal coil) and a proximal end 111, where the distal end 109 is fixed to the distal end of the delivery wire 108A and the proximal end 111 is connected to the distal end 114 of the expandable member 112 via an occlusion attachment region 120 between the distal end 109 and the distal end 114 of the expandable member 112. The occlusion attachment region 120 can include a wire mesh portion for connecting the removal tool 110 and the expandable member 112. In some embodiments, the expandable member 112 and the removal tool 110 may each be part of a continuous wire mesh structure.

[0052] The ends of the removal tool 110 and / or expandable member 112 may include marker bands that are coupled to corresponding portions of the delivery wire 108A and delivery tube 108B. As shown in Figures 5A-5C, the proximal end 116 of the expandable member 112 is coupled to the distal end of the delivery tube 108B such that pulling the delivery tube 108B back relative to the delivery wire 108A (or pushing the delivery wire 108A forward relative to the delivery tube 108B) can cause the removal tool 110 and expandable member 112 to contract, while pulling the delivery wire 108A back relative to the delivery tube 108B (or pushing the delivery tube 108B forward relative to the delivery wire 108A) can cause the removal tool 110 and expandable member 112 to expand.

[0053] 3B, 4C, and 5C, in some embodiments, the removal tool 110 may include a support frame 122 (e.g., one or more rigid or semi-rigid structures) that may provide structural reinforcement to the removal tool 110 when the removal tool 110 is in the deployed (i.e., extended) configuration. The support frame 122 may be configured to fold (e.g., fold towards the delivery tool 108) when the removal tool 110 is in the folded state. Additionally or alternatively, the removal tool 110 may include a non-uniform wire mesh. For example, the structure of the removal tool 110 may include a thick, strong, and / or dense wire mesh at the distal end 109 of the removal tool 110 to provide a strong cone / funnel-shaped structure when the removal tool 110 is deployed / expanded, and a thin, weak, and / or less dense wire mesh at the proximal end 111 of the removal tool 110 to provide flexibility to the removal tool 110 so that it can be more easily expanded / contracted.

[0054] 1A-5C or combinations thereof, the expandable member 112 may be configured to be convertible between a contracted / collapsed state and an expanded state. The expandable member 112 may be configured to be convertible between the contracted state and the expanded state by any suitable means, including but not limited to exposing the expandable member 112 to allow expansion and wrapping / re-wrapping the expandable member 112 to induce contraction thereof.

[0055] In the expanded state, the expandable member 112 can surround at least a portion of the removal tool 110 and / or the obstruction 101, and in the contracted state, the expandable member 112 is suitable for inserting or withdrawing the obstruction removal device (including the expandable member 112 and removal tool 110) through the guide catheter 104 and / or intermediate catheter 106. For example, when the expandable member 112 is in a collapsed / contracted state surrounding at least a portion of the removal tool 110 and / or the obstruction 101, the expandable member 112, together with the removal tool 110, can be withdrawn through the guide catheter 104 and / or intermediate catheter 106 to remove the obstruction 101 from the vascular system 102.

[0056] Advantages of surrounding at least a portion of the removal tool 110 and / or obstruction 101 with the expandable member 112 include, but are not limited to, reduced cross-sectional area, reduced friction at the vessel wall, reduced likelihood of getting caught in the openings of the guide catheter 104 and / or intermediate catheter 106, and reduced likelihood of the obstruction being displaced.

[0057] As can be seen generally with reference to the embodiments of the obstruction removal system 100 disclosed herein, the expandable member 112 may be configured to be transformed between the first and second configurations, or between the contracted and expanded states, by any number of means, including, but not limited to, exposing the expandable member 112 (which may be accomplished, for example, by pulling back the intermediate catheter 106 or threading the expandable member 112 through the guide catheter 104), detaching a locking member (e.g., wire, hook, etc.) attached to the expandable member 112, using a shape memory alloy (e.g., Nitinol), etc. From the above, it is believed that the expandable member may occupy a majority of a cross-section of the vasculature 102 when in an expanded state.

[0058] In one embodiment, the expandable member 112, removal tool 110, and occlusion 101 are pulled back into the guide catheter 104 and removed from the vascular system 102. In some embodiments, the expandable member 112, removal tool 110, and occlusion 101 may be further pulled back into the intermediate catheter 106. The expandable member 112 can not only surround at least a portion of the occlusion 101 to prevent its displacement, but can also contribute to compressing (e.g., by pulling, tightening, rolling, etc.) the occlusion 101 for storage within the guide catheter 104 and / or intermediate catheter 106.

[0059] The expandable member 112 may surround at least a portion of the removal tool 110 and / or the obstruction 101 to perform various functions, including, but not limited to, reducing the likelihood that the removal tool 110 will get caught (e.g., on the inner surface / vessel wall of the vascular system 102 or on an opening in the guide catheter 104), reducing the profile of the obstruction 101 so that it may be removed by the guide catheter 104 and / or intermediate catheter 106, and / or immobilizing the obstruction 101 to prevent it from displacing from the removal tool 110.

[0060] In one embodiment, the removal tool 110 and / or the expandable member 112 may include a wire mesh. Such a wire mesh may include wires made of a flexible material (e.g., Nitinol, Cobalt Chromium, polymer mesh (e.g., PET, Nylon, etc.) where the wires (e.g., 16-288 or more wires) have a certain diameter (e.g., 0.0005 inches to 0.0050 inches) and certain material properties (e.g., strength, coefficient of friction with blood, resistance to plastic deformation, etc.) suitable for abutting the occlusion 101 and / or the removal tool 110. The wire mesh may be single or multi-layered. The wire mesh may also include various groups of wires (e.g., large diameter support wires, wires that abut the vessel wall, wires that abut the occlusion or portions of the occlusion removal device, radiopaque or x-ray opaque wires, etc.).

[0061] Any number of the disclosed members are suitable for imaging by non-invasive imaging techniques (e.g., x-ray, CT scan, etc.). For example, the guide catheter 104, intermediate catheter 106, delivery tool 108, removal tool 110, expandable member 112, and / or any additional components may comprise a radiopaque or radiopaque material suitable for introduction into the human body (e.g., titanium, tungsten, barium sulfate, zirconium oxide, DFT wire (Drawn Filled Tube), etc.). In some embodiments, the removal tool 110 and the expandable member 112 are both part of the same wire mesh structure formed from a radiopaque or radiopaque material (e.g., DFT wire).

[0062] It should be understood that any number of components included in the obstruction removal system 100 may be connected by any suitable means, including, but not limited to, welding, adhesives, mechanical fastening, an interference fit, etc. For example, the delivery tool 108 may be attached to the removal tool 110 and / or the expandable member 112 by such means. Alternatively or additionally, two or more components may each be part of the same structure (e.g., the same mold or print).

[0063] It is contemplated that one or more devices in the obstruction removal system 100 may be placed in different sequences, depending on factors such as, but not limited to, vascular system characteristics (e.g., vascular system size, vascular system geometry, vascular system branching, vascular system wall strength, etc.), blood pressure, blood flow direction, duration of procedure (i.e., does the procedure time need to be reduced for patient safety reasons), obstruction size, or obstruction removal device specifications.

[0064] Generally, referring to FIGS. 1A-5C, a method for removing obstructions from a vascular system 102 includes: inserting a guide catheter 104 into the patient's vascular system 102 to a location adjacent the obstruction 101; extending a delivery tool 108 having a removal tool 110 attached to its end through the guide catheter 104 to position the distal end of the delivery tool 108 (with or without the intermediate catheter 106) in the vascular system 102 near the occlusion 101; removing at least a portion of the obstruction 101 in the vascular system 102 by at least partially separating the obstruction 101 from an inner surface of the vascular system 102 with a removal tool 110; encircling at least a portion of the occlusion material 101 and the removal tool 110 with the expandable member 112, wherein the proximal end 116 of the expandable member 112 is configured to evert or slide toward the distal end 114 of the expandable member 112, such that the occlusion material 101 is captured between the expandable member 112 and the removal tool 110 when the delivery tool 108 is retracted from the vascular system 102 to remove the removal tool 110 and the occlusion material 101 from the vascular system 102; The process may include, but is not limited to, these steps.

[0065] It should be noted that embodiments of the methods disclosed herein may include one or more of the steps described herein. These steps may be performed in any desired order, and in some embodiments, two or more steps may be performed simultaneously. Two or more steps disclosed herein may be combined into a single step, and in some embodiments, one or more steps may be performed as two or more substeps. Other steps or substeps may be performed in addition to or instead of one or more steps disclosed herein.

[0066] It should be noted that the terms used in this disclosure are not intended to be limiting. For example, "occlusion" as used herein may refer to any vascular obstruction, including, but not limited to, blood clots, plaque (e.g., fat, cholesterol, etc.), internal structures / growths, foreign bodies, etc.

[0067] Although the present invention has been described above with reference to the embodiments shown in the drawings, the configurations described herein may be replaced with equivalents without departing from the scope of the present invention as defined in the claims. The elements shown and described herein are merely examples of equipment and members that may realize the embodiments of the present invention, and may be replaced with other equipment and members without departing from the scope of the present invention. Furthermore, unless otherwise specifically described in the claims, any dimensions, degrees and / or numerical ranges described herein should be considered as non-limiting examples.

Claims

1. a guide catheter configured to be inserted into the vascular system; a delivery tool having a distal end configured to be inserted into the guide catheter and positioned near an obstruction in the vascular system; a removal tool disposed at the distal end of the delivery tool and configured to at least partially separate the occlusion material from an interior surface of the vascular system; an expandable member coupled to the delivery tool; the expandable member is formed from a portion of a continuous wire mesh, another portion of the continuous wire mesh further forming the removal tool and obstruction attachment area; the removal tool includes a cone or umbrella-shaped portion configured to at least partially surround the obstruction, the removal tool having a support frame that may provide structural reinforcement to the removal tool when in a deployed configuration; the expandable member has a proximal end that is free or slidably coupled to the delivery tool relative to the delivery tool, the proximal end of the expandable member being configured to invert or slide relative to the delivery tool such that at least a portion of an outer surface of the expandable member at least partially surrounds the occlusion material toward a distal end of the expandable member, thereby causing the expandable member to surround at least a portion of the occlusion material and at least a portion of the removal tool, such that the occlusion material is captured between the expandable member and the removal tool when the delivery tool is retracted from the vascular system to remove the removal tool and the occlusion material from the vascular system; The obstruction removal system, wherein the obstruction attachment area is defined between the removal tool and the expandable member.

2. The obstruction removal system of claim 1 , wherein the distal end of the expandable member is coupled to the delivery tool, either fixedly or slidably relative to the delivery tool.

3. The proximal end of the expandable member comprises: a delivery tool coupled to the delivery tool so as to be slidable relative to the delivery tool; configured to slide relative to the delivery tool toward the distal end of the expandable member when the delivery tool is retracted from the vascular system to remove the removal tool and the occlusion material from the vascular system; an intermediate portion of the expandable member configured to fold over the distal end of the expandable member and over at least a portion of the removal tool; This means:

2. The occlusion removal system of claim 1, wherein the occlusion becomes trapped between the expandable member and the removal tool as the proximal end of the expandable member slides relative to the delivery tool toward the distal end of the expandable member as the delivery tool is pulled back from the vascular system to remove the removal tool and the occlusion from the vascular system.

4. 2. The occlusion removal system of claim 1, wherein the proximal end of the expandable member is free and configured to invert so that the inner and outer surfaces of the expandable member alternate to cover the distal end of the expandable member and at least a portion of the removal tool, such that the occlusion is trapped between the expandable member and the removal tool when the delivery tool is retracted from the vascular system to remove the removal tool and the occlusion from the vascular system.

5. The occlusion removal system of claim 1 , further comprising an intermediate catheter configured to encase the removal tool and the expandable member as the delivery tool is inserted into the guide catheter and guided into the vascular system.

6. 6. The occlusion removal system of claim 5, wherein the intermediate catheter is further configured to expose the removal tool and the expandable member to allow the removal tool to at least partially separate the occlusion from an inner surface of the vascular system.

7. The obstruction removal system of claim 1 , wherein the delivery tool comprises at least one of a guidewire or a tube.

8. A removal tool disposed at a distal end of the delivery tool and configured to at least partially separate the occlusion material from an inner surface of the vascular system; an expandable member coupled to the delivery tool; the expandable member is formed from a portion of a continuous wire mesh, another portion of the continuous wire mesh further forming the removal tool and obstruction attachment area; the removal tool having a cone or umbrella-shaped portion configured to at least partially surround the obstruction; the expandable member has a proximal end that is free or slidably coupled to the delivery tool relative to the delivery tool, the proximal end of the expandable member being configured to invert or slide relative to the delivery tool such that inner and outer surfaces of the expandable member are inverted and concave toward the distal end of the expandable member causing at least a portion of the outer surface of the expandable member to at least partially surround the occlusion, thereby causing the expandable member to surround at least a portion of the occlusion and at least a portion of the removal tool, such that the occlusion becomes trapped between the expandable member and the removal tool when the delivery tool is retracted from the vascular system to remove the removal tool and the occlusion from the vascular system; The obstruction removal device, wherein the obstruction attachment area is defined between the removal tool and the expandable member.

9. 9. The occlusion removal device of claim 8, wherein the distal end of the expandable member is coupled to the delivery tool, either fixedly or slidably relative to the delivery tool.

10. The proximal end of the expandable member comprises: a delivery tool coupled to the delivery tool so as to be slidable relative to the delivery tool; configured to slide relative to the delivery tool toward the distal end of the expandable member when the delivery tool is retracted from the vascular system to remove the removal tool and the occlusion material from the vascular system; an intermediate portion of the expandable member configured to fold over the distal end of the expandable member and over at least a portion of the removal tool; This means:

9. The occlusion removal device of claim 8, wherein the occlusion becomes trapped between the expandable member and the removal tool as the proximal end of the expandable member slides relative to the delivery tool toward the distal end of the expandable member as the delivery tool is pulled back from the vascular system to remove the removal tool and the occlusion from the vascular system.

11. 9. The occlusion removal device of claim 8, wherein the proximal end of the expandable member is free and configured to invert so that the inner and outer surfaces of the expandable member alternate to cover the distal end of the expandable member and at least a portion of the removal tool, such that the occlusion is trapped between the expandable member and the removal tool when the delivery tool is retracted from the vascular system to remove the removal tool and the occlusion from the vascular system.

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