Device for removing obstructive substances from blood vessels

Abstract

A medical device (10) includes: a shaft (38); and a cage (30) coupled to the shaft, the cage including an elongate cutting member (306) configured to cut material within a blood vessel lumen, the cage including a first end (302) and a second end (304), wherein one or both of the first end and the second end are movable along a longitudinal axis of the shaft to change a distance between the first end and the second end; wherein the cage has a natural expanded configuration having a first cross-sectional dimension (D1); wherein the cage is contractible to form a contracted configuration in response to an increase in the distance between the first end and the second end of the cage; and wherein the medical device further includes a controller (40) configured to apply a radial force to expand the cage beyond its natural expanded configuration to have a second cross-sectional dimension greater than the first cross-sectional dimension.

Description

[0001] Field

[0002] The field of the present application relates to medical devices and methods for using such medical devices to remove substances (such as arterial plaque) from blood vessels, and more particularly, to medical devices and methods for cutting and removing obstructive substances (such as plaque) within blood vessels.

[0003] Background

[0004] Medical devices have been used to remove obstructive substances, such as plaque, from within the lumen of blood vessels. Some of these devices may have a cutting element that is configured to cut the substance along the wall of the blood vessel. The cutting element may have a predetermined relaxed expanded configuration that allows the cutting element to cut the substance along the wall of the blood vessel. However, during the cutting operation, such a cutting element may not be able to expand further beyond the predetermined relaxed expanded configuration.

[0005] In addition, existing medical devices for removing substances from blood vessels may not have a filter that can effectively and reliably collect the cut substance and debris. If such substances and / or debris leave the target site in the blood vessel, they may pose a health risk to the patient. Accordingly, there is a need for improved devices and methods for removing substances from within the lumen of blood vessels.

[0006] Summary

[0007] In an exemplary embodiment of the disclosed invention, a device for removing obstructive substances from a blood vessel lumen includes a shaft having a longitudinal axis and a cage coupled to the shaft, the cage being sized to be placed within a blood vessel and including a plurality of elongate cutting members configured to cut substances within the blood vessel, wherein the cage includes a first end and a second end; wherein the first end, the second end, or both the first end and the second end are movable along the longitudinal axis of the shaft to change the distance between the first end and the second end of the cage; wherein when no external stress is applied to the cage, the cage has a natural expanded configuration, and when the cage is in the natural expanded configuration, the cage has a first cross-sectional dimension; wherein the cage is contractible to form a contracted configuration in response to an increase in the distance between the first end and the second end of the cage; and wherein the device further includes a controller configured to apply a radial force to expand the cage beyond its natural expanded configuration such that the cage has a second cross-sectional dimension greater than the first cross-sectional dimension.

[0008] Optionally, the medical device further includes a filter coupled to the first end of the cage.

[0009] Optionally, the filter and the cage are configured to expand and / or contract simultaneously in response to relative movement between the first end and the second end of the cage.

[0010] Optionally, a first cutting member of the cutting members extends from a first end of the cage to a second end of the cage in a helical configuration.

[0011] Optionally, a second cutting member of the cutting members extends from the first end of the cage to the second end of the cage in another helical configuration, and at least a portion of the first cutting member is parallel to at least a portion of the second cutting member.

[0012] Optionally, the cutting members each have a cutting edge, and when the cage is in a natural expanded configuration, each cutting edge faces in a direction parallel to or away from the wall of the blood vessel.

[0013] Optionally, the cutting members each have a cutting edge facing proximally.

[0014] Optionally, the cutting members each have a cutting edge facing distally.

[0015] Optionally, the medical device further includes a handle, wherein a controller is implemented on the handle and is configured to decrease and / or increase the distance between the first end and the second end of the cage.

[0016] Optionally, the medical device further includes a balloon coupled proximally to the cage, wherein the balloon is expandable to occlude a blood vessel.

[0017] Optionally, the medical device further includes a tube having a port, wherein the tube is configured to receive the cage, and the cage is movable distally relative to the tube to exit the tube via the port.

[0018] Optionally, the medical device further includes a balloon catheter having a lumen configured to receive at least a portion of the tube.

[0019] Optionally, the shaft includes an outer elongate member and an inner elongate member disposed within the outer elongate member and slidable relative to the outer elongate member.

[0020] Optionally, a first end of the cage is coupled to the inner elongate member, and a second end of the cage is coupled to the outer elongate member.

[0021] Optionally, the inner elongate member has a solid cross-section.

[0022] A medical device, comprising: a shaft having a longitudinal axis; a cage coupled to the shaft, the cage being sized to be placed within a blood vessel and including a plurality of elongate cutting members configured to cut material within the blood vessel, wherein the cage includes a first end and a second end; and a filter coupled to the cage; wherein the first end, the second end, or both the first end and the second end, can move along the longitudinal axis of the shaft to change the distance between the first end and the second end of the cage; and wherein the filter and the cage are configured to expand and / or contract simultaneously in response to relative movement between the first end and the second end of the cage.

[0023] Optionally, the first cutting member in the cutting member extends from the first end of the cage to the second end of the cage in a helical configuration.

[0024] Optionally, the second cutting member of the cutting member extends from the first end of the cage to the second end of the cage in another helical configuration, and at least a portion of the first cutting member is parallel to at least a portion of the second cutting member.

[0025] Optionally, the cutting members each have a respective cutting edge, and when the cage is in the expanded configuration, each cutting edge faces in a direction parallel to or away from the wall of the blood vessel.

[0026] Optionally, the cutting members each have a cutting edge facing proximally.

[0027] Optionally, the cutting members each have a cutting edge facing distally.

[0028] Optionally, the medical device further includes a handle having a controller, wherein the controller is configured to decrease and / or increase the distance between the first end and the second end of the cage.

[0029] Optionally, the medical device further includes a balloon coupled proximally to the cage, wherein the balloon is expandable to occlude the blood vessel.

[0030] Optionally, the medical device further includes a tube having a port, wherein the tube is configured to receive the cage, and the cage is movable distally relative to the tube to exit the tube via the port.

[0031] Optionally, the medical device further includes a balloon catheter having a lumen configured to receive at least a portion of the tube.

[0032] Optionally, the shaft includes an outer elongate member and an inner elongate member, the inner elongate member being disposed within the outer elongate member and slidable relative to the outer elongate member.

[0033] Optionally, the first end of the cage is coupled to the inner elongate member, and the second end of the cage is coupled to the outer elongate member.

[0034] Optionally, the inner elongate member has a solid cross-section.

[0035] Optionally, when no external stress is applied to the cage, the cage has a natural expanded configuration, and when the cage is in the natural expanded configuration, the cage has a first cross-sectional dimension; and wherein the medical device further includes a controller configured to apply a radial force to expand the cage beyond its natural expanded configuration such that the cage has a second cross-sectional dimension greater than the first cross-sectional dimension.

[0036] A medical method includes: occluding a blood vessel via an expandable balloon coupled to a tube; a cage presenting a natural expanded configuration, the cage including a plurality of elongate cutting members, wherein the action of the cage presenting the natural expanded configuration is performed when the cage is in the blood vessel and when the cage is outside the tube, and wherein when the cage is in the natural expanded configuration, the cage has a first cross-sectional dimension; the cage presenting an enhanced expanded configuration, the enhanced expanded configuration having a second cross-sectional dimension greater than the first cross-sectional dimension; and cutting a substance in the blood vessel via the elongate cutting members of the cage.

[0037] Optionally, the cage includes a first end and a second end, and wherein the action of the cage presenting the enhanced expanded configuration is performed in response to a decrease in the distance between the first end and the second end of the cage.

[0038] Optionally, the method further includes capturing the substance by a filter after the substance is cut.

[0039] Optionally, the method further includes the filter presenting an expanded configuration; wherein the action of the filter presenting the expanded configuration and the action of the cage presenting the natural expanded configuration are performed simultaneously.

[0040] Optionally, the action of cutting the substance includes using the blades of the elongate cutting members respectively, and wherein the blades of the elongate cutting members face proximally.

[0041] Optionally, the action of cutting the substance includes using the blades of the elongate cutting members respectively, and wherein the blades of the elongate cutting members face distally.

[0042] Other and further aspects and features will become apparent by reading the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] The drawings illustrate the design and use of embodiments, where like elements are denoted with the same reference numerals. These drawings are not necessarily to scale. To better understand how to obtain the above and other advantages and objects, embodiments will be described in more detail, which are shown in the drawings. These drawings depict only exemplary embodiments and should not be considered as limiting the scope of the claims.

[0044] Figure 1 Illustrated is a medical device configured to remove a substance in a blood vessel, particularly illustrating a medical device having a cage in a contracted configuration.

[0045] Figure 2 Illustrated is Figure 1 the medical device, particularly illustrating the cage in a natural expanded configuration.

[0046] Figure 3 Illustrated is Figure 1 the medical device, particularly illustrating the cage in an enhanced expanded configuration.

[0047] Figure 4 Illustrates Figure 1 a cross-section of a portion of the cage of , particularly showing that the cutting edge of the cutting member of the cage faces in a direction parallel to the wall of the blood vessel.

[0048] Figure 5 Illustrates Figure 1 a cross-section of a portion of the cage of , particularly showing that the cutting edge of the cutting member of the cage cuts into the substance in the blood vessel.

[0049] Figure 6 Illustrates Figure 1 A medical device of is used in a blood vessel to remove substances.

[0050] Figure 7 Illustrates another medical device.

[0051] Figure 8 Illustrates Figure 7 a medical device of , further including a catheter / tube.

[0052] Figure 9 Illustrates Figure 8 a medical device of , further including a balloon catheter.

[0053] Figure 10 Illustrates a method for removing substances in a blood vessel according to some embodiments.

[0054] Detailed description

[0055] Various embodiments are described below with reference to the accompanying drawings. It should be noted that the drawings are not drawn to scale, and in all the drawings, elements of similar structure or function are denoted by the same reference numerals. It should also be noted that the drawings are only intended to facilitate the description of the embodiments. They are not an exhaustive description of the present invention, nor are they a limitation on the scope of the present invention. In addition, the illustrated embodiments do not necessarily have all the aspects or advantages shown. The aspects or advantages described in connection with a particular embodiment are not necessarily limited to that embodiment and may be practiced in any other embodiment, even if not so shown or if not so explicitly described.

[0056] Figures 1-3 Illustrates a medical device 10 configured to remove substances in a blood vessel lumen according to some embodiments of the disclosed invention. The medical device 10 includes a tube 20, a cage 30 received in the tube 20 and extendable out of the tube 20, a shaft 38 coupled to the cage 30, and a controller 40 configured to manipulate the tube 20 and / or the cage 30.

[0057] The tube 20 has a distal end 104, a proximal end 106, and a body 108 extending between the distal end 104 and the proximal end 106. In the illustrated embodiment, the tube 20 further includes a balloon 110 located at the distal end 104 of the tube 20. The proximal end 106 of the tube 20 is coupled to a hub 200 at a controller 40. The hub 200 has a port 202 that is configured to receive fluid from a fluid source 204 for inflation of the balloon 110. The port 202 can also be configured to withdraw fluid from the balloon 110 to deflate the balloon 110. Optionally, another port at the hub 200 can be configured to withdraw fluid from the balloon 110 to deflate the balloon 110. The balloon 110 is sized to occlude a blood vessel when the balloon 110 is inflated.

[0058] The cage 30 is sized to be placed within a blood vessel. As Figures 1-2 shown, the cage 30 has a first end (distal end) 302, a second end (proximal end) 304, and a plurality of cutting members 306 that are configured to cut material within the blood vessel. As Figure 1 shown, when the cage 30 is contained within the lumen 122 of the tube 20, the cage 30 is in a collapsed configuration. As Figure 2 shown, when the cage 30 is deployed outside of the distal end 104 of the tube 20 via a port 109, the cage 30 is in a natural expanded configuration. When the cage 30 is in the natural expanded configuration, no stress is applied to the cage 30 (i.e., no outward radial force is applied externally to expand the cage 30), and the shape of the cage 30 in the natural expanded configuration depends on the preformed shape of the cutting members 306 and their elasticity. As Figure 2 shown, when in the natural expanded configuration, the cage 30 has a first cross-sectional dimension D1. Due to the preformed shape of the cutting members 306 and their elasticity, the cage 30 acts like a spring, i.e., when the cage 30 is deployed outside of the tube 20, the cage 30 springs open to form the natural expanded configuration. This action of the cage 30 pulls the first end 302 of the cage 30 towards the second end 304 of the cage 30, pulls the second end 304 towards the first end 302, or pulls the first end 302 and the second end 304 towards each other, thereby reducing the distance between the first end 302 of the cage 30 and the second end 304 of the cage 30.

[0059] Reference Figures 1-2, the shaft 38 includes an outer elongated member 310 and an inner elongated member 320. The inner elongated member 320 is located inside the outer elongated member 310 and is slidable relative to the outer elongated member 310. The outer elongated member 310 has a distal end 312 and a proximal end 314. The second end 304 of the cage 30 is coupled to the distal end 312, and the proximal end 314 is coupled to the first handle portion 330 of the controller 40. The inner elongated member 320 has a distal end 322 and a proximal end 324. The first end 302 of the cage 30 is coupled to the distal end 322, and the proximal end 324 is coupled to the second handle portion 340 of the controller 40. In the illustrated embodiment, the inner elongated member 320 of the shaft 38 has a solid cross-section along its length. In some cases, the inner elongated member 320 can be implemented using wire. In other embodiments, the inner elongated member 320 of the shaft 38 can include one or more cavities.

[0060] In the illustrated embodiment, the first end 302 of the cage 30, the second end 304 of the cage 30, or both the first end 302 and the second end 304 of the cage 30 can move along the longitudinal axis of the shaft 38 to change the distance between the first end 302 and the second end 304 of the cage 30. For example, the cage 30 is contractible to form a contracted configuration in response to an increase in the distance between the first end 302 and the second end 304 of the cage 30. Specifically, the first handle portion 330 and the second handle portion 340 of the controller 40 can be manipulated by a user to increase the distance between the first end 302 and the second end 304 of the cage 30, thereby causing the cage 30 to contract to produce Figure 1 the illustrated contracted configuration. The cage 30 can also expand beyond its natural expanded configuration in response to a decrease in the distance between the first end 302 and the second end 304 of the cage 30. Specifically, the first handle portion 330 and the second handle portion 340 of the controller 40 can be manipulated by a user to apply a radial force to expand the cage 30 beyond its natural expanded configuration such that the cage 30 has a second cross-sectional dimension D2 that is greater than the first cross-sectional dimension D1 ( Figure 3 ). As Figure 3 shown, the distance between the first handle portion 330 and the second handle portion 340 is increased to decrease the distance between the first end 302 of the cage 30 and the second end 304 of the cage. This produces a radial force that causes the cage 30 to expand beyond its natural expanded configuration.

[0061] It should be noted that the controller 40 is not limited to the illustrated configuration, and in other embodiments, the controller 40 can have other configurations. For example, in other embodiments, one or each of the first handle portion 330 and the second handle portion 340 can be implemented as a shifter, button, knob, etc. on the handle. Additionally, in some embodiments, the hub 200 can be implemented as part of the handle or can be separated from the handle.

[0062] AsFigures 1-3 As shown, the medical device 10 further includes a filter 380 coupled to the first end 302 of the cage 30. In some cases, the filter 380 can be a soft and / or elastic net coupled to one or more cutting members 306. This is advantageous because it allows the filter 380 and the cage 30 to expand and / or contract simultaneously in response to relative movement between the first end 302 and the second end 304 of the cage 30. Coupling the filter 380 to the cutting member 306 is also advantageous because as the cutting member 306 expands radially, the filter 380 will also expand radially accordingly. This allows the size of the filter 380 to be automatically adjusted in response to changes in the size of the cage 30. The filter 380 can be made of a variety of materials. As a non-limiting example, the filter 380 can be implemented using a polymer fabric, flashspun fabric, etc. Additionally, in some embodiments, the filter 380 can have a nose cone configuration.

[0063] In some embodiments, the first cutting member of the cutting member 306 extends from the first end 302 of the cage 30 to the second end 304 of the cage 30 in a helical configuration. Similarly, the second cutting member of the cutting member extends from the first end 302 of the cage 30 to the second end 304 of the cage 30 in another helical configuration, wherein at least a portion of the first cutting member is parallel to at least a portion of the second cutting member.

[0064] In some embodiments, the cutting member 306 has respective cutting edges that, when the cage 30 is in the expanded configuration, each face in a direction parallel to or away from the wall of the blood vessel. For example, in some embodiments, the cutting members 306 of the cage 30 each have a first cutting edge facing proximally. In this case, after the cage 30 is deployed into the blood vessel, moving the cage 30 proximally relative to the blood vessel will cause the proximally facing cutting edge to cut into the material attached to the inner wall of the blood vessel. Optionally or additionally, the cutting members 306 of the cage 30 each have a second cutting edge facing distally. In this case, moving the cage 30 distally relative to the blood vessel will cause the distally facing cutting edge to cut into the material attached to the inner wall of the blood vessel.

[0065] As discussed, in some embodiments, when the cage 30 is in the expanded configuration, each cutting member 306 has a cutting edge that faces only proximally or distally, or both proximally and distally simultaneously. This is beneficial because it can prevent the cutting member 306 from cutting into the wall of the blood vessel. For example, as Figure 4 shown, if the cutting members 306 each have a cutting edge that faces only in the proximal direction, the cutting members 306 will not cut into the wall of the blood vessel even when engaged with the wall of the blood vessel. On the other hand, if the expanded cage 30 engages with the material along the wall of the blood vessel, the cutting edges of the cutting members 306 will cut into the material ( Figure 5 ).

[0066] As Figures 2-3 shown, when the cage 30 is in the expanded configuration, the cutting members 306 are separated from each other to form an open porous body of the cage 30. This allows fluid (e.g., aspiration fluid, blood, etc.) to leave and / or enter the cage 30. Further, as shown, the cutting members 306 extend in an approximately parallel manner such that the cutting members 306 do not cross each other. This configuration is advantageous because it allows substances in the blood vessel to more easily enter between the cutting members 306, allowing the cutting members 306 to more effectively cut the substances in the blood vessel. In other embodiments, one or more of the cutting members 306 may cross other cutting members 306. For example, in other embodiments, the cutting members 306 may form a grid configuration.

[0067] It should be noted that the medical device 10 is not limited to the features and configurations described in the above embodiments, and the medical device 10 may have other features and configurations in other embodiments. For example, in other embodiments, the tube 20 may not include the balloon 110, and the controller 40 may not include the hub 200. In additional embodiments, the medical device 10 may not include the tube 20. In other embodiments, the medical device 10 may not include the filter 380. In additional embodiments, the inner elongate member 320 of the shaft 38 may have one or more lumens that may be used to accommodate a guide wire, deliver substances (e.g., drugs, saline, aspiration fluid, etc.), and / or remove substances from the patient's body.

[0068] Further, in other embodiments, the medical device 10 may optionally further include a sheath configured to receive the cage 30. In such a case, the sheath may be disposed within the lumen 122 of the tube 20 and be slidable relative to the tube 20. During use, the sheath containing the cage 30 may be advanced distally such that the distal portion of the sheath will move out of the port 109 at the distal end 104 of the tube 20. After the distal portion of the sheath (containing the cage 30 in its collapsed configuration) has exited the tube 20, the cage 30 may then be deployed outside of the sheath such that the cage 30 can expand into the expanded configuration. This can be achieved by retracting the sheath proximally relative to the cage 30 or by advancing the cage 30 distally relative to the sheath.

[0069] Further, in other embodiments, the distal end 104 of the tube 20 and / or the distal end of the sheath (if the medical device 10 includes a sheath) may have a sharp tip configured to pierce tissue and / or substances in a blood vessel.

[0070] In addition, in other embodiments, the medical device 10 may include a manipulation mechanism configured to manipulate the distal end 104 of the tube 20 or the distal end of the sheath (if the medical device 10 includes a sheath). The manipulation mechanism may include one or more manipulation wires, and the one or more manipulation wires are coupled to the distal end of the tube 20 or the distal end of the sheath for applying tension to bend the distal end of the tube 20 or the distal end of the sheath. In this case, the controller 40 may include buttons, knobs, sliders, etc. for allowing the user to apply tension to the manipulation wires.

[0071] In addition, in the above embodiments, the cage 30 is described as having a natural expansion configuration. In other embodiments, the cage 30 may not have a natural expansion configuration. Instead, the cage 30 may have a contracted configuration (as Figure 1 shown), i.e., its natural relaxed configuration. In this case, after the cage 30 is deployed outside the tube 20, the cage 30 will not automatically spring open. Instead, the cage 30 will remain in the contracted configuration. The first handle portion 330 and / or the second handle portion 340 can be manipulated to apply a radial force to expand the cage 30 from its contracted configuration. During use, the first handle portion 330 and / or the second handle portion 340 can be repeatedly manipulated to change the size of the cage 30, thereby adjusting the magnitude of the force applied by the cage 30 to the wall of the blood vessel or to the substance in the blood vessel.

[0072] Figure 1 The medical device 10 as Figure 6 shown can be used in a blood vessel to remove a substance. First, the tube 20 of the medical device 10 is inserted into a patient's blood vessel and advanced until the distal end 104 of the tube 20 reaches the target site in the blood vessel. As

[0073] shown, the distal end 104 of the tube 20 in the blood vessel 402 can be placed proximal to the substance 410 to be removed.

[0074] As Figure 6As shown, after the distal end 104 of the tube 20 has been ideally positioned, fluid for inflation from the fluid source 204 is delivered via the port 202 to inflate the balloon 110 at the distal end 104 of the tube 20. The inflated balloon 110 occludes the blood vessel to be treated. In some cases, the inflated balloon 110 stops the blood flow proximal to the lesion to be removed in the blood vessel.

[0075] When the tube 20 is within the blood vessel, the cage 30 is initially contained within the tube 20 such that the cage 30 has a contracted configuration, as Figure 1 shown. Next, the cage 30 within the tube 20 is advanced distally to exit the distal end 104 of the tube 20. This can be achieved by manually advancing the second handle portion 340 relative to the hub 200 at the controller 40 or manually advancing both the first handle portion 330 and the second handle portion 340. After the cage 30 exits the tube 20, depending on the inherent shape of the cage 30, the cage 30 automatically assumes its natural expanded configuration, as Figure 2 shown. In some embodiments, the cross-sectional dimension D1 of the natural expanded configuration is smaller than the diameter of the blood vessel lumen. In some cases, to place the cage 30 distally relative to the substance 410, the controller 40 can be operated to contract the cage 30 while the cage 30 is outside the tube 20. For example, the second handle portion 340 can be advanced distally towards the first handle portion 330, or the first handle portion 330 can be retracted proximally towards the second handle portion 340 to increase the distance between the first end 302 of the cage 30 and the second end 304 of the cage, thereby contracting the cage 30. The contracted cage 30 can then be advanced distally until it has passed through the substance 410 to a position distal to the substance 410. Next, the manipulation force applied by the user on the first handle portion 330 and / or the second handle portion 340 can be released, thereby allowing the cage 30 to assume its natural expanded configuration while the cage 30 is located distal to the substance 410.

[0076] In other embodiments, if the cage 30 does not have a natural expanded configuration, after the cage 30 is deployed outside the tube 20, the cage 30 will continue to have a contracted configuration. In such a case, the cage 30 in the contracted configuration can be advanced distally until it has passed through the substance 410 to a position distal to the substance 410. Then, when the cage 30 is distal to the substance 410, the controller 40 can be manipulated to expand the cage 30.

[0077] In other cases, if the medical device 10 includes an additional sheath that contains the cage 30, the sheath (with the cage 30 in its contracted configuration) can be advanced distally relative to the tube 20 to exit the tube 20. The distal end of the sheath and the cage 30 contained therein can be advanced distally such that the distal end of the sheath and the cage 30 are located distal to the substance 410. Next, the sheath can be retracted to deploy the cage 30 outside the sheath, resulting in the deployed cage 30 being distal to the substance 410.

[0078] Next, the cage 30 is moved proximally relative to the blood vessel to cut the substance 410 along the inner wall of the blood vessel 402( Figure 6 ). This can be achieved by moving the first handle portion 330 proximally relative to the hub 200 at the controller 40, or by moving both the first handle portion 330 and the second handle portion 340 proximally (as Figures 1-3 shown).

[0079] In some cases, if the cutting element 306 of the cage 30 has a distally facing cutting edge, the cage 30 can also be moved distally relative to the blood vessel to cut the substance 410 along the inner wall of the blood vessel 402. This can be achieved by moving the first handle portion 330 distally relative to the hub 200 at the controller 40, or by moving both the first and second handle portions 330, 340 distally.

[0080] In some cases, if the cross-sectional dimension D1 of the natural expanded configuration of the cage 30 is smaller than the lumen diameter of the blood vessel 402, the cage 30 can be expanded beyond its natural expanded configuration such that the cage 30 has a cross-sectional dimension D2 that is larger than the cross-sectional dimension D1 (similar to Figure 3 shown). In particular, the second handle portion 340 can be moved proximally relative to the first handle portion 330 to pull the first end 302 of the cage 30 toward the second end 304 of the cage 30. This creates an outward radial force that causes the cage 30 to expand further beyond its natural expanded configuration.

[0081] In addition, in some cases, if the natural expanded configuration of the cage 30 has circumferentially abutted against the inner wall of the blood vessel 402, the cage 30 can still be expanded beyond its natural expanded configuration to increase the abutting force exerted by the cage 30 against the inner wall of the blood vessel 402. This technique can allow the cage 30 to be used to cut the substance 410 closer to the inner wall of the blood vessel 402.

[0082] In addition, in one technique of using the medical device 10, when the cage 30 is used to cut the substance 410, the radial expansion force of the cage 30 against the wall of the blood vessel 402 can be selectively adjusted. For example, by pulling the second handle portion 340 proximally relative to the first handle portion 330, or by advancing the first handle portion 330 distally relative to the second handle portion 340, the user of the medical device 10 can increase the abutting force exerted by the cage 30 against the substance 410 or the wall of the blood vessel 402. This has the effect of bringing the first end 302 and the second end 304 of the cage 30 closer to each other to cause the cage 30 to expand radially. As a result, more of the substance 410 can enter between the cutting members 306 to allow more of the substance 410 to be cut from the blood vessel wall. Thus, the controller 40 can be used to adjust the amount (e.g., thickness) of the substance 410 desired to be cut from the blood vessel 402.

[0083] As the cage 30 cuts the material 410 from the blood vessel 402, the cut material 410 is captured by the filter 380, which prevents the material 410 from leaving the target site in the blood vessel 402. Since the filter 380 is coupled to the cutting element 306 of the cage 30, regardless of the size formed by the cage 30 during the use of the medical device 10, the size of the filter 380 will change accordingly to match the size of the cage 30 (e.g., cross-sectional size).

[0084] In some embodiments, the port 109 at the distal end 104 of the tube can be used to collect the cut material 410, debris, aspirated fluid, and / or blood. Alternatively, another suction tube can be provided in the tube 20 to collect the cut material 410, debris, aspirated fluid, and / or blood from inside the blood vessel.

[0085] It should be noted that the medical device 10 is not limited to the exemplary features and configurations described in the foregoing embodiments, and the medical device 10 can have other features and / or configurations. For example, in other embodiments, the medical device 10 may not include the tube 20. Instead, the medical device 10 may only include the cage 30 coupled to the handles 330, 340 via respective elongate members 310, 320 ( Figure 7 ). In this case, the medical device 10 can insert another device (e.g., a catheter, such as a microcatheter, balloon catheter, etc.) during use. In some embodiments, the elongate member 320 can be stiff enough to provide tension and / or pressure during use.

[0086] In addition, in other embodiments, Figure 7 the medical device 10 can further include a catheter (tube) 600 for accommodating the cage 30 and the elongate member 310 ( Figure 8 ). The catheter 600 can include a handle 610 for allowing the user to manipulate. During use, by advancing the handle 330 distally relative to the handle 610, the cage 30 can be deployed beyond the distal end of the catheter 600. In some embodiments, the catheter 600 can be a microcatheter.

[0087] In additional embodiments, Figure 8 the medical device 10 can further include a balloon catheter 620 ( Figure 9 ). The balloon catheter 620 includes an inflatable balloon 622 and a handle 624. The inflatable balloon 622 is configured to occlude the blood vessel when inflated, and the handle 624 has a port 626 that receives fluid for inflation to inflate the balloon 622. The balloon catheter 620 is configured to accommodate Figure 7a catheter / tube 600, where the catheter / tube 600 houses the cage 30. During use, by advancing the handle 610 distally relative to the handle 624 of the balloon catheter 620, the distal portion of the catheter / tube 600 containing the cage 30 can be deployed outside the balloon catheter 620 while the cage 30 is contained inside the catheter / tube 600. Then, the cage 30 can be deployed outside the distal end of the catheter / tube 600. This can be achieved by retracting the catheter / tube 600 proximally relative to the cage 30 or by advancing the cage 30 distally relative to the catheter / tube 600. Figure 9 The medical device 10 is advantageous because it allows adjustment of the deployment position of the cage 30 even after the balloon 622 is inflated and fixed within a blood vessel. In other embodiments, the medical device 10 may not include the catheter / tube 600, and the balloon catheter 620 may be configured to directly house the cage 30 and the elongate member 310 without the catheter / tube 600.

[0088] Figure 10 Illustrated is a method 700 for clearing substances in a blood vessel according to some embodiments. The method 700 includes occluding the blood vessel via an expandable balloon coupled to a tube (item 702). The method 700 further includes the cage presenting a natural expanded configuration, the cage including a plurality of elongate cutting members, wherein the action of the cage presenting the natural expanded configuration is performed when the cage is in the blood vessel and when the cage is outside the tube, and wherein the cage has a first cross-sectional dimension when in the natural expanded configuration (item 704). The method 700 further includes the cage presenting an enhanced expanded configuration having a second cross-sectional dimension greater than the first cross-sectional dimension (item 706); and cutting the substances in the blood vessel via the elongate cutting members of the cage (item 708).

[0089] Optionally, in the method 700, the cage includes a first end and a second end, and wherein the action of the cage presenting the enhanced expanded configuration is performed in response to a decrease in the distance between the first end and the second end of the cage.

[0090] Optionally, the method 700 further includes capturing the substances by a filter after the substances are cut.

[0091] Optionally, the method 700 further includes the filter presenting an expanded configuration; wherein the action of the filter presenting the expanded configuration and the action of the cage presenting the natural expanded configuration are performed simultaneously.

[0092] Optionally, in the method 700, the action of cutting the substances includes using the blades of the elongate cutting members respectively, and wherein the blades of the elongate cutting members face proximally.

[0093] Optionally, in the method 700, the action of cutting the substances includes using the blades of the elongate cutting members respectively, and wherein the blades of the elongate cutting members face distally.

[0094] The following items are exemplary features of the embodiments described herein. Each item may be an embodiment itself or may be part of an embodiment. In one embodiment, one or more of the items described below may be combined with other items.

[0095] Item 1: A medical device, comprising: a shaft having a longitudinal axis, and a cage coupled to the shaft, the cage being sized to be placed in a blood vessel and including a plurality of elongated cutting members configured to cut substances within the blood vessel, wherein the cage includes a first end and a second end; wherein the first end, the second end, or both the first end and the second end are movable along the longitudinal axis of the shaft to change the distance between the first end and the second end of the cage; wherein when no external stress is applied to the cage, the cage has a natural expanded configuration, and when the cage is in the natural expanded configuration, the cage has a first cross-sectional dimension; wherein the cage is contractible to form a contracted configuration in response to an increase in the distance between the first end and the second end of the cage; and wherein the medical device further includes a controller configured to apply a radial force to expand the cage beyond its natural expanded configuration such that the cage has a second cross-sectional dimension greater than the first cross-sectional dimension.

[0096] Item 2: The medical device further includes a filter coupled to the first end of the cage.

[0097] Item 3: In the medical device, the filter and the cage are configured to expand and / or contract simultaneously in response to relative movement between the first end and the second end of the cage.

[0098] Item 4: In the medical device, a first cutting member of the cutting members extends from the first end to the second end of the cage in a helical configuration.

[0099] Item 5: In the medical device, a second cutting member of the cutting members extends from the first end to the second end of the cage in another helical configuration, and wherein at least a portion of the first cutting member is parallel to at least a portion of the second cutting member.

[0100] Item 6: In the medical device, the cutting members each have a cutting edge, and when the cage is in the natural expanded configuration, each cutting edge faces a direction parallel to or away from the wall of the blood vessel.

[0101] Item 7: In the medical device, the cutting members each have a cutting edge facing proximally.

[0102] Item 8: In the medical device, the cutting members each have a cutting edge facing distally.

[0103] Item 9: The medical device further includes a handle, wherein the controller is implemented on the handle and is configured to decrease and / or increase the distance between the first end and the second end of the cage.

[0104] Item 10: The medical device further includes a balloon coupled proximally to the cage, wherein the balloon is expandable to occlude a blood vessel.

[0105] Item 11: The medical device further includes a tube having a port, wherein the tube is configured to receive the cage and the cage is movable distally relative to the tube to exit the tube via the port.

[0106] Item 12: The medical device further includes a balloon catheter having a lumen configured to receive at least a portion of the tube.

[0107] Item 13: In the medical device, the shaft includes an outer elongate member and an inner elongate member disposed within the outer elongate member and slidable relative to the outer elongate member.

[0108] Item 14: In the medical device, a first end of the cage is coupled to the inner elongate member and a second end of the cage is coupled to the outer elongate member.

[0109] Item 15: In the medical device, the inner elongate member has a solid cross-section.

[0110] Item 16: A medical device includes: a shaft having a longitudinal axis; a cage coupled to the shaft, the cage sized to be placed within a blood vessel and including a plurality of elongate cutting members configured to cut material within the blood vessel, wherein the cage includes a first end and a second end; and a filter coupled to the cage; wherein the first end, the second end, or both the first end and the second end are movable along the longitudinal axis of the shaft to change the distance between the first end and the second end of the cage; and wherein the filter and the cage are configured to expand and / or contract simultaneously in response to relative movement between the first end and the second end of the cage.

[0111] Item 17: In the medical device, a first cutting member of the cutting members extends from the first end of the cage to the second end of the cage in a helical configuration.

[0112] Item 18: In the medical device, a second cutting member of the cutting members extends from the first end of the cage to the second end of the cage in another helical configuration and wherein at least a portion of the first cutting member is parallel to at least a portion of the second cutting member.

[0113] Item 19: In the medical device, the cutting members each have a cutting edge such that when the cage is in an expanded configuration, each cutting edge faces in a direction parallel to or away from the wall of the blood vessel.

[0114] Item 20: In the medical device, the cutting members each have a cutting edge facing proximally.

[0115] Item 21: In the medical device, the cutting members each have a cutting edge facing distally.

[0116] Item 22: The medical device further includes a handle having a controller, wherein the controller is configured to decrease and / or increase the distance between the first end and the second end of the cage.

[0117] Item 23: The medical device further includes a balloon coupled proximally to the cage, wherein the balloon is expandable to occlude a blood vessel.

[0118] Item 24: The medical device further includes a tube having a port, wherein the tube is configured to receive the cage, and the cage is movable distally relative to the tube to exit the tube via the port.

[0119] Item 25: The medical device further includes a balloon catheter having a lumen configured to receive at least a portion of the tube.

[0120] Item 26: In the medical device, the shaft includes an outer elongate member and an inner elongate member disposed within the outer elongate member and slidable relative to the outer elongate member.

[0121] Item 27: In the medical device, the first end of the cage is coupled to the inner elongate member, and the second end of the cage is coupled to the outer elongate member.

[0122] Item 28: In the medical device, the inner elongate member has a solid cross-section.

[0123] Item 29: In the medical device, when no external stress is applied to the cage, the cage has a natural expanded configuration, and when the cage is in the natural expanded configuration, the cage has a first cross-sectional dimension; and wherein the medical device further includes a controller configured to apply a radial force to expand the cage beyond its natural expanded configuration such that the cage has a second cross-sectional dimension greater than the first cross-sectional dimension.

[0124] Item 30: A medical method includes: occluding a blood vessel via an expanded balloon coupled to a tube; the cage assuming a natural expanded configuration, the cage including a plurality of elongate cutting members, wherein the action of the cage assuming the natural expanded configuration is performed when the cage is in the blood vessel and when the cage is outside the tube, and wherein when the cage is in the natural expanded configuration, the cage has a first cross-sectional dimension; the cage assuming an enhanced expanded configuration, the enhanced expanded configuration having a second cross-sectional dimension greater than the first cross-sectional dimension; and cutting a substance in the blood vessel via the elongate cutting members of the cage.

[0125] Item 31: In the method, the cage includes a first end and a second end, and wherein the action of the cage assuming the enhanced expanded configuration is performed in response to a decrease in the distance between the first end and the second end of the cage.

[0126] Item 32: The method further includes capturing the substance by a filter after the substance is cut.

[0127] Item 33: The method further includes presenting the filter in an expanded configuration; wherein the action of presenting the filter in the expanded configuration and the action of presenting the cage in the natural expanded configuration are performed simultaneously.

[0128] Item 34: In the method, the action of cutting the substance includes using the cutting edge of the elongate cutting member respectively, and wherein the cutting edge of the elongate cutting member faces proximally.

[0129] Item 35: In the method, the action of cutting the substance includes using the cutting edge of the elongate cutting member respectively, and wherein the cutting edge of the elongate cutting member faces distally.

[0130] Accordingly, it should be understood that in addition to the various embodiments of the medical device disclosed herein, a method of removing a substance from within a blood vessel using such a device is also disclosed, including but not limited to a method that includes the following actions: occluding the blood vessel via an expandable balloon coupled to a tube; presenting the cage in a natural expanded configuration, the cage including a plurality of elongate cutting members, wherein the action of presenting the cage in the natural expanded configuration is performed when the cage is within the blood vessel and when the cage is outside the tube, and wherein when the cage is in the natural expanded configuration, the cage has a first cross-sectional dimension; presenting the cage in an enhanced expanded configuration, the enhanced expanded configuration having a second cross-sectional dimension greater than the first cross-sectional dimension; and cutting the substance within the blood vessel via the elongate cutting members of the cage. The cage may include a first end and a second end, and wherein the action of presenting the cage in the enhanced expanded configuration is performed in response to a decrease in the distance between the first end and the second end of the cage. The method may further include capturing the substance by a filter after the substance is cut. The method may further include presenting the filter in an expanded configuration; wherein the action of presenting the filter in the expanded configuration and the action of presenting the cage in the natural expanded configuration are performed simultaneously. The action of cutting the substance may include using the cutting edge of the elongate cutting member respectively, and wherein the cutting edge of the elongate cutting member faces proximally or distally.

Claims

1. A medical device, comprising: a shaft having a longitudinal axis; and a cage coupled to the shaft, the cage being sized to be placed within a blood vessel and including a plurality of elongated cutting members configured to cut material within the blood vessel, wherein the cage includes a first end and a second end; wherein the first end, the second end, or both the first end and the second end are capable of moving along the longitudinal axis of the shaft to change the distance between the first end and the second end of the cage; wherein when no external stress is applied to the cage, the cage has a natural expanded configuration, and when the cage is in the natural expanded configuration, the cage has a first cross-sectional dimension; wherein the cage is contractible to form a contracted configuration in response to an increase in the distance between the first end and the second end of the cage; and wherein the medical device further includes a controller configured to apply a radial force to expand the cage beyond its natural expanded configuration such that the cage has a second cross-sectional dimension greater than the first cross-sectional dimension; wherein at least one of the cutting members has a first cutting edge and a second cutting edge, and when the cage is in the natural expanded configuration, each of the first cutting edge and the second cutting edge faces a direction parallel to or away from the wall of the blood vessel, wherein the first cutting edge faces proximally and the second cutting edge faces distally.

2. The medical device according to claim 1, further comprising a filter coupled to the first end of the cage.

3. The medical device according to claim 2, wherein, The filter and the cage are configured to be capable of expanding simultaneously and / or capable of contracting simultaneously in response to relative movement between the first end and the second end of the cage.

4. The medical device according to any one of claims 1-3, wherein, A first cutting member among the cutting members extends from the first end of the cage to the second end of the cage in a helical configuration.

5. The medical device according to claim 4, wherein, A second cutting member among the cutting members extends from the first end of the cage to the second end of the cage in another helical configuration, and wherein at least a portion of the first cutting member is parallel to at least a portion of the second cutting member.

6. The medical device according to any one of claims 1-3 and 5, wherein, Each of the cutting members has a first cutting edge facing proximally.

7. The medical device according to claim 4, wherein, Each of the cutting members has a first cutting edge facing proximally.

8. The medical device according to any one of claims 1-3 and 5, wherein, Each of the cutting members has a second cutting edge facing distally.

9. The medical device according to claim 4, wherein, Each of the cutting members has a second cutting edge facing distally.

10. The medical device according to any one of claims 1-3, 5, 7, and 9, further comprising a handle, wherein the controller is implemented on the handle and is configured to decrease and / or increase the distance between the first end and the second end of the cage.

11. The medical device according to claim 4, further comprising a handle, wherein the controller is implemented on the handle and is configured to decrease and / or increase the distance between the first end and the second end of the cage.

12. The medical device according to claim 6, further comprising a handle, wherein the controller is implemented on the handle and is configured to decrease and / or increase the distance between the first end and the second end of the cage.

13. The medical device according to claim 8 further comprises a handle, wherein the controller is implemented on the handle and is configured to decrease and / or increase the distance between the first end and the second end of the cage.

14. The medical device according to any one of claims 1-3, 5, 7, 9 and 11-13 further comprises a balloon, the balloon being coupled proximally to the cage, wherein the balloon is expandable to occlude the blood vessel.

15. The medical device according to any one of claims 1-3, 5, 7, 9 and 11-13 further comprises a tube having a port, wherein the tube is configured to receive the cage and the cage is movable distally relative to the tube to exit the tube via the port.

16. The medical device according to claim 15 further comprises a balloon catheter having a lumen configured to receive at least a portion of the tube.

17. The medical device according to any one of claims 1-3, 5, 7, 9, 11-13 and 16, wherein, The shaft includes an outer elongate member and an inner elongate member, the inner elongate member being disposed within the outer elongate member and slidable relative to the outer elongate member.

18. The medical device according to claim 17, wherein, The first end of the cage is coupled to the inner elongate member while the second end of the cage is coupled to the outer elongate member.

19. The medical device according to claim 17, wherein, The inner elongate member has a solid cross-section.

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