Dual action thrombectomy catheter

Abstract

A thrombectomy device includes a handle, a catheter, and a cutting assembly at a distal end of the catheter. The thrombectomy device includes two oppositely wound helical wires that, when rotated in opposite directions, cooperate to transport thrombus material from the distal end of the catheter to the proximal end of the thrombectomy device without the thrombus material adhering to the inner lumen of the catheter.

Description

TECHNICAL FIELD

[0001] The devices and methods described herein relate generally to the treatment of occluded body lumens, such as removing occlusive material, including thrombus, from a subject's vasculature. BACKGROUND

[0002] Various devices are used to clear thrombus, also known as blood clots, in percutaneous coronary intervention (PCI) and peripheral vessel interventions. For example, certain mechanical cutting catheters and aspiration catheters are currently used to remove thrombus. Due to the nature of thrombus, as it travels from the distal end of the catheter to the proximal end of the catheter, the thrombus can stick to the inner lumen of the catheter, even with suction.

[0003] US 2006 / 0229646 Al discloses a catheter system for operating within a stenotic blood vessel. The catheter system includes a catheter shaft having at least one lumen. The catheter system also includes a convex distal housing including a series of openings along a convex surface that allow blood vessel plaque tissue to enter an interior of the distal housing. The catheter system further includes an internal rotary cutter having a blade that approximates the portion of the interior surface of the distal housing that includes the openings. In addition, the catheter system includes a drive shaft coupled with the internal rotary cutter. SUMMARY

[0004] There is a need for a medical device that can perform thrombectomy and better transport the thrombus through the thrombectomy device from its distal end to its proximal end without sticking to the inner lumen of the catheter portion of the thrombectomy device. The present disclosure proposes a thrombectomy system and device that achieves this goal.

[0005] An example of a thrombectomy device includes a handle configured to be manipulated by a user, a catheter extending from the handle, a cutting assembly, wherein the cutting assembly includes a drive shaft having a proximal end, a distal end, and an inner helical coil affixed to the drive shaft, wherein the inner helical coil is wound in a first direction, an inner cutting head coupled to the distal end of the drive shaft, wherein the inner cutting head includes a plurality of openings, wherein each of the openings of the inner cutting head includes a respective number of cutting edges, an outer helical coil radially spaced apart from the drive shaft and the inner helical coil, wherein the outer helical coil is wound in a second direction opposite the first direction, an outer cutting head coupled to the distal end of the second helical coil, wherein the outer cutting head includes a plurality of openings, wherein each of the openings of the outer cutting head includes a respective number of cutting edges, wherein the inner cutting head is disposed radially within the outer cutting head and is rotatable relative to the outer cutting head, and an outer sheath disposed over the outer helical coil, and a drive mechanism disposed within the handle, wherein upon operation of the drive mechanism, the rotatable drive shaft and the inner cutting head rotate in the first direction, the outer helical coil and the outer cutting head rotate in the second direction, and the rotation of the inner helical coil and the outer helical coil appears to move from the distal end to the proximal end.

[0006] The thrombectomy device according to any of the preceding paragraphs, wherein the first direction is a clockwise direction.

[0007] The thrombectomy device according to any of the preceding paragraphs, wherein the second direction is a counterclockwise direction.

[0008] The thrombectomy device according to any of the preceding paragraphs, wherein the inner cutting head includes an inner blade.

[0009] The thrombectomy device according to any of the preceding paragraphs, wherein the inner blade is disposed within the inner cutting head.

[0010] The thrombectomy device according to any of the preceding paragraphs, wherein the inner blade is substantially perpendicular to the cutting edges of the inner cutting head.

[0011] The thrombectomy device according to any of the preceding paragraphs, wherein the inner blade has a curved shape.

[0012] The thrombectomy device according to any of the preceding paragraphs, wherein the curved shape resembles a sickle.

[0013] The phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that are both combined and separate in use. For example, each of the expressions “at least one of A, B, and C,” “at least one of A, B, or C,” “one or more of A, B, and C,” “one or more of A, B, or C,” and “A, B, and / or C” refers to a single A, a single B, a single C, A and B together, A and C together, B and C together, or A, B, and C together. When each of A, B, and C in the above expressions refers to an element (e.g., X, Y, and Z) or a class of elements (e.g., X1-X), the meaning is different. n Y1-Y m and Z1-Z o When used, this phrase is intended to refer to a single element selected from X, Y, and Z, or a combination of elements selected from the same category (e.g., X1 and X2), or a combination of elements selected from two or more categories (e.g., Y1 and Z). o ).

[0014] The term "a" or "an" entity refers to one or more of the same entity. Therefore, the terms "a" (or "an"), "one or more," and "at least one" are used interchangeably herein. It should also be noted that the terms "comprising," "including," and "having" are used interchangeably.

[0015] Therefore, claims containing the term "means" should cover all structures, materials, or actions set forth herein, and all their equivalents. Furthermore, structures, materials, or actions, and their equivalents, should include all content described in the summary, description of drawings, detailed description, abstract, and claims.

[0016] It should be understood that each maximum numerical limit given throughout this disclosure is considered to include, as alternative to, every and every lower numerical limit, as if such lower numerical limits were expressly stated herein. Each minimum numerical limit given throughout this disclosure is considered to include, as alternative to, every and every larger numerical limit, as if such larger numerical limits were expressly stated herein. Each numerical range given in this disclosure is considered to include, as if falling within that wider numerical range, every and every narrower numerical range, as if such narrower numerical ranges were all expressly stated herein.

[0017] The foregoing is a simplified summary of this disclosure, intended to provide an understanding of some aspects of the disclosure. This summary is a neither extensive nor exhaustive overview of the disclosure and its various aspects, embodiments, and configurations. As will be understood, other aspects, embodiments, and configurations of this disclosure may utilize one or more features described above or in detail below, individually or in combination. Attached Figure Description

[0018] The accompanying drawings, which are incorporated in and form a part of the specification, illustrate various examples of the present disclosure. These drawings, together with the description, explain the principles of the disclosure. The drawings simply illustrate preferred and alternative examples of how the disclosure can be made and used, and should not be construed to limit the present disclosure to only the examples illustrated and described. Other features and advantages will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, as determining aspects, embodiments, and configurations of the present disclosure, as illustrated in the drawings.

[0019] Figure 1 is a side / schematic view of an example of a thrombectomy system according to the present disclosure.

[0020] Figure 2 is a detailed side view of a distal portion of a thrombectomy device of Figure 1

[0021] Figure 3 is a detailed perspective, cutaway view of a distal portion of a thrombectomy device of Figure 1

[0022] Figure 4A is a detailed perspective, exploded view of a distal portion of a thrombectomy device of Figure 3

[0023] Figure 4B is a perspective view of an inner cutting head of a thrombectomy device of Figure 1

[0024] Figure 5A is a perspective view of a distal portion and a proximal portion of a thrombectomy device according to an example of the present disclosure, the thrombectomy device including a cutting assembly and a drive system coupled to an inner cutting head and an outer cutting head.

[0025] Figure 5B is a perspective view of an inner cutting head and a drive system coupled to the inner cutting head according to an example of the present disclosure.

[0026] It should be understood that the drawings are not necessarily to scale. In certain instances, details that are not necessary for an understanding of the present disclosure or that render other details difficult to perceive can have been omitted. It should be understood, of course, that the present disclosure is not necessarily limited to the particular embodiments illustrated herein. DETAILED DESCRIPTION

[0027] ​​​​Before any embodiments of the present disclosure are explained in detail, it is to be understood that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The present disclosure is capable of other embodiments and of being practiced or being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

[0028] The present disclosure relates generally to devices, systems, and methods for performing thrombectomy. Although the present disclosure primarily discusses the use of the devices and systems to perform thrombectomy, the devices and systems discussed herein can be used to perform other vascular procedures, such as atherectomy. Reference is made to Figure 1 , an example thrombectomy system 100 described herein is shown. The thrombectomy system 100 includes an intravascular thrombectomy device 102 and a guidewire 104 over which the thrombectomy device 102 can be deployed within a subject's vasculature. In some embodiments, the guidewire 104 is silicon-coated or uncoated (bare), or otherwise lacks a PTFE coating. Thrombectomy systems according to some embodiments of the present disclosure include a guidewire 104 having a PTFE coating, or atherectomy systems according to some embodiments of the present disclosure lack a guidewire.

[0029] With continued reference to Figure 1 The thrombectomy device 102 generally includes a handle 106 and a catheter 108. The handle 106 is configured to be grasped and manipulated by a user (e.g., a medical professional) during a thrombectomy procedure or other vascular procedure. The catheter 108 is coupled to the handle 106 and extends distally relative to the handle 106. The catheter 108 is configured to be positioned in a subject's (e.g., a patient's) vasculature during a thrombectomy procedure to facilitate removal of an occlusive material (e.g., a thrombus) from the vasculature. In some embodiments and as shown, a distal portion 110 of the catheter 108 has a curved shape or configuration. In some embodiments, the distal portion 110 of the catheter 108 generally has a curved configuration ( "generally" is understood to mean that the catheter 108 is not affected by any external contact forces, e.g., from contact with a vessel wall) and can be deflected to other configurations. In other embodiments, the distal portion 110 of the catheter 108 generally has a straight shape or configuration and can be deflected to other configurations. In some embodiments, the catheter 108 is selectively rotatable relative to the handle 106 about a catheter rotation axis 112 to facilitate proper positioning of the distal portion 110 of the catheter 108 and / or to "sweep" the distal portion 110 of the catheter 108 during atherectomy. In some embodiments and as shown, the handle 106 is provided with a switch 120 for rotating the catheter 108 relative to the handle 106. Reference is made to Figure 2The catheter 108 includes an outer sheath 116 that is coupled with a cutter assembly 200 that extends distally from the outer sheath 116. The cutter assembly 200 will be described in further detail below. Although not shown in the figures, the thrombectomy device 102 can also include another outer sheath that is stationary and connected with the distal end of the handle 106 to minimize damage to the blood vessel by the rotating catheter 108.

[0030] Referring now to Figure 3 , Figure 4A and Figure 4B , a distal portion 110 of the catheter 108 is illustrated that includes, among other components, the outer sheath 116 and the cutter assembly 200. The cutter assembly 200 includes a rotating outer cutting head 202 and a rotating inner cutting head 204 that is radially, concentrically disposed within the outer cutting head 202. The outer cutting head 202 has a plurality of openings 214, and at least a portion of the outer cutting head 202 that forms the openings 214 includes sharp cutting edges (or blades) 216. The inner cutting head 204 has a plurality of openings 218, and at least a portion of the inner cutting head 204 that forms the openings 218 includes sharp cutting edges (or blades) 220.

[0031] Preferably, the number of openings 218 in the inner cutting head 204 is the same as the number of openings 214 in the outer cutting head 202. As will be discussed in detail below, the inner cutting head 204 will rotate in one direction, while the outer cutting head 202 will rotate in the opposite direction. For example, viewed from the proximal end of the cutter assembly 200 in a distal direction, the inner cutting head 204 will rotate in a clockwise direction, while the outer cutting head 202 will rotate in a counterclockwise direction. Because the outer cutting head 202 and the inner cutting head 204 both rotate in opposite directions, the respective edges 216, 220 of the cutting heads 202, 204 act like a pair of scissors and cut a thrombus within a subject’s vasculature.

[0032] The inner cutting head 204 can also have one or more inner blades 224 disposed within the inner cutting head 204. The inner blades 224 are generally perpendicular to the sharp cutting edges (or blades) 220. After the respective edges 216, 220 of the cutting heads 202, 204 have cut the thrombus, the cut portions of the thrombus enter the inner cutting head 204, and the inner blades 224 rotate and cut the thrombus into smaller pieces. The inner blades 224 can have a curved shape similar to a sickle, and the curved sickle shape can function or act like a turbine to further draw the thrombus material into the inner cutting head 204 and push the material proximally within the catheter 108. The cutting depth of the curved inner blades 224 is designed to be coordinated with the rotational speed of the outer blades 216. For example, slow rotation or stop-start of the inner blades 224 and the outer blades 220 and 216, respectively, results in a fenestration effect through which the thrombus material protrudes and enters the inner cutting head 204 for cutting. Conversely, high speed effectively pushes the thrombus material away from the rotating sharp edges of the cutting heads 202, 204 to minimize cutting by the inner blades 224. Thus, the depth of cutting can be controlled by the rotational speed. As will be clear from the description of the drive system below, the cutting heads 202, 204 rotate at the same or substantially the same speed.

[0033] With continued reference to Figure 3 , Figure 4A and Figure 4B , the inner cutting head 204 (e.g., the proximal end of the inner cutting head 204) is fixedly coupled to the distal end of the rotatable drive shaft 206, which can have a lumen extending therethrough. The outer cutting head 202 (e.g., the proximal end of the outer cutting head 202) is fixedly coupled to the distal end of the rotatable helical coil 208, which can also be referred to as an outer helical coil. Specifically, the outer cutting head 202 is coupled to the distal end of the rotatable helical coil 208 by a coupling 212. The coupling 212 has a lumen through which the rotatable drive shaft 206 passes. That is, the rotatable drive shaft 206 is configured to freely rotate relative to the coupling 212. Further, the rotatable drive shaft 206 rotates in one direction while the coupling 212 rotates in the opposite direction. The helical coil 208 drives the outer cutting head 202 (and the coupling 212) in one direction, while the rotatable drive shaft 206 drives the inner cutting head 204 in the opposite direction. As noted above, the inner cutting head 204 will rotate in a clockwise direction, while the outer cutting head 202 will rotate in a counterclockwise direction. Thus, the rotatable drive shaft 206 rotates in a clockwise direction and drives the inner cutting head 204 in a clockwise direction, while the helical coil 208 rotates in a counterclockwise direction and rotates the outer cutting head 202 in a counterclockwise direction.

[0034] As Figure 3 , Figure 4A and Figure 4BAs shown, helical coil 208 is wound in a clockwise direction as it extends axially from its proximal end to its distal end. Drive shaft 206 also includes a helical coil 222 affixed to drive shaft 206. Helical coil 222 can also be referred to as an inner helical coil. Helical coil 222 is wound in a direction opposite to the direction in which outer helical coil 208 is wound. That is, inner helical coil 222 is wound in a counterclockwise direction as it extends axially from its proximal end to its distal end. Because rotatable drive shaft 206 and inner cutting head 204 rotate in a clockwise direction, while inner helical coil 222 is wound in a counterclockwise direction from its proximal end to its distal end, inner helical coil 222 transports thrombus material through catheter 108 in a direction from its distal end to its proximal end because inner helical coil 222 appears to move from the distal end of catheter 108 toward the proximal end of catheter 108. Also, because outer helical coil 208 and outer cutting head 202 rotate in a counterclockwise direction, and outer helical coil 208 is wound in a clockwise direction from its proximal end to its distal end, outer helical coil 208 transports thrombus material through catheter 108 in a direction from its distal end to its proximal end because outer helical coil 208 appears to move from the distal end of catheter 108 toward the proximal end of catheter 108. That is, even though inner helical coil 222 and outer helical coil 208 have coil winding configurations in opposite directions, and inner helical coil 222 and outer helical coil 208 rotate in opposite directions, the winding configurations of inner helical coil 222 and outer helical coil 208 cooperate and work in concert to move thrombus material through catheter 108 in the same direction (from the distal end of catheter 108 to its proximal end) because as the winding configurations of inner helical coil 222 and outer helical coil 208 rotate, they pull and convey thrombus material in the same direction (i.e., from the distal end of catheter 108 to its proximal end). Because the winding configurations of inner helical coil 222 and outer helical coil 208 cooperate and work in concert to move thrombus material in the same direction through catheter 108 in thrombectomy device 102, from the distal end of the device to the proximal end of the device, without sticking to the inner lumen of catheter 108. Although not shown in any of the figures, thrombectomy system 100 and / or thrombectomy device 102 can be configured to provide suction to catheter 108 to further enhance the transport of thrombus. In addition, saline, drugs, and other liquids can be injected distally through ports or holes drilled radially through drive shaft 206 to allow the liquid to migrate from within hollow drive shaft 206 into the catheter space to suspend and / or lubricate and / or dissolve thrombus, thereby suspending it for improved proximal movement toward the handle, where optional suction can assist in removing thrombus material.

[0035] Reference Figure 5A and 5BThe diagram illustrates a device for driving and rotating a rotatable drive shaft 206 to rotate in one direction and for driving and rotating a helical coil 208 to rotate in the opposite direction. This drive device may be housed within the handle 106 of the thrombectomy device 102 and includes a set of planetary gears, wherein a distal gear 226 is fixedly coupled to the drive shaft 206, which is fixedly coupled to a motor (not shown). Since the distal gear 226 is fixedly coupled to the drive shaft 206, when the user activates a switch 120 electrically connected to the motor, the motor causes the distal gear 226 and the drive shaft 206 to rotate clockwise. Two planetary gears 228, 230 connect the proximal planetary gear 226 to the distal planetary gear 232 and are configured to rotate the proximal planetary gear 232 in the opposite direction to the distal planetary gear 226 (i.e., counterclockwise). The planetary distal gear 232 is connected to the outer helical coil 208 via a coupling 224, which may be a separate component or integrated with the planetary distal gear 232. Similar to the coupling 212, the drive shaft 206 passes through a cavity in the coupling 224 and / or the planetary distal gear 232, and the drive shaft 206 rotates in the opposite direction to the rotation of the coupling 224.

[0036] The foregoing discussion has been given for purposes of illustration and description. The foregoing is not intended to limit this disclosure to one or more of the forms disclosed herein. For example, the lumen in drive shaft 206 allows a variety of devices to pass through it, such as guidewires, ultrasound catheters, vision systems, inflatable nets for capturing debris, and fluid or drug delivery.

[0037] In the foregoing summary section, for the purpose of simplifying this disclosure, various features of this disclosure have been combined in one or more aspects, embodiments, and / or configurations. Features of aspects, embodiments, and / or configurations of this disclosure may be combined in alternative aspects, embodiments, and / or configurations different from those discussed above. This disclosure approach should not be construed as reflecting an intention that the claims require more features than expressly recited in each claim. Rather, as reflected in the following claims, the inventive aspect lies in fewer than all features of a single foregoing aspect, embodiment, and / or configuration. Therefore, the following claims are incorporated herein by reference, and each claim stands independently as a separate preferred embodiment of this disclosure.

[0038] Furthermore, although the description has included descriptions of one or more aspects, embodiments and / or configurations, as well as certain variations and modifications, other variations, combinations and modifications are also within the scope of this disclosure, for example, which may be within the skill and knowledge of those skilled in the art after understanding this disclosure.

Claims

1. A thrombectomy device (102), comprising: A handle (106) configured to be operated by a user; A conduit (108) extends from the handle; Cutting assembly (200), wherein the cutting assembly includes: A drive shaft (206) having a proximal end, a distal end, and an inner helical coil (222) attached to the drive shaft, wherein the inner helical coil is wound along a first direction; An inner cutting head (204) is coupled to the distal end of the drive shaft, wherein the inner cutting head includes a plurality of openings (218), wherein each of the openings of the inner cutting head includes a corresponding number of cutting blades (220). An outer helical coil (208) is radially spaced from the drive shaft and the inner helical coil, wherein the outer helical coil is wound in a second direction opposite to the first direction; An outer cutting head (202) is coupled to the distal end of the outer spiral coil, wherein the outer cutting head includes a plurality of openings (214), each of the openings of the outer cutting head including a corresponding number of cutting blades (216), wherein the inner cutting head is radially disposed within the outer cutting head and is rotatable relative to the outer cutting head; and Outer sheath (116), which is disposed on the outer helical coil; and A drive mechanism is disposed within the handle and configured such that, during operation of the drive mechanism, the rotatable drive shaft and the inner cutting head rotate in the first direction, and the outer helical coil and the outer cutting head rotate in the second direction; The inner cutting head includes an inner blade (224), and the inner blade is disposed inside the inner cutting head.

2. The thrombectomy device according to claim 1, wherein, The first direction is clockwise.

3. The thrombectomy device according to claim 2, wherein, The second direction is counterclockwise.

4. The thrombectomy device according to claim 1, wherein, The inner blade is perpendicular to the cutting edge of the inner cutting head.

5. The thrombectomy device according to claim 4, wherein, The inner blade has a curved shape.

6. The thrombectomy device according to claim 5, wherein, The curved shape resembles a sickle.

7. A thrombectomy system (100), comprising: The thrombectomy device (102) according to any one of claims 1 to 6; and Guide wire (104); The thrombectomy device is configured to be placed on the guidewire into the blood vessel.

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