Atherectomy device including an axially oscillating cutting element

Abstract

A plaque removal device includes a cutter assembly. The cutter assembly includes a housing including a housing support surface. The cutter assembly also includes a cutting element rotatably and translationally carried by the housing. The cutting element includes at least one cutting blade configured to cut obstructive material as the cutting element is rotated relative to the housing. The cutting element also includes a cutter support surface configured to engage the housing support surface. As the cutting element is rotated relative to the housing and the at least one cutting blade cuts the obstructive material, the cutting element is translated distally relative to the housing until the cutter support surface engages the housing support surface.

Description

Technical Field

[0001] The devices and methods described herein generally relate to the treatment of occluded body cavities, such as removing occlusive material from blood vessels or other body parts. Background Technology

[0002] Peripheral and interventional cardiology is a medical specialty that involves the treatment of various forms of cardiovascular disease, including coronary artery disease and peripheral vascular disease. Coronary artery disease and peripheral vascular disease can result from narrowing of the arteries caused by atherosclerosis (also known as arteriosclerosis). Coronary artery disease generally affects the arteries of the heart—the arteries that carry blood to the heart muscle and surrounding tissues. Peripheral vascular disease refers to various diseases of the vascular system outside the heart and brain (for example, those that carry blood to the legs).

[0003] Atherosclerosis typically affects medium and large arteries and occurs when fat, cholesterol, and other substances accumulate on the arterial walls, forming fleshy or hard / calcified structures known as plaques / lesions. When plaques form within the arterial walls, the arteries may narrow and become less flexible, making it harder for blood to flow. In peripheral arteries, plaques are usually not localized but can extend up to 10 millimeters or more (and in some cases, 400 millimeters or more) along the axis of the artery.

[0004] Fragments of plaque can break off and travel through the affected artery to smaller vessels, potentially blocking them and causing tissue damage or death (embolism). In some cases, atherosclerotic plaques may be associated with weakening of the affected artery wall, which can lead to aneurysms. Minimally invasive surgery can be performed to remove plaque from arteries in an effort to alleviate or help prevent complications of atherosclerosis.

[0005] Several interventional procedures can be used to treat atherosclerosis. For example, in balloon angioplasty, a surgeon can advance a constricted intravascular balloon catheter into the narrowed artery and inflate the balloon to crush plaque and / or displace it against the vessel wall. Successful angioplasty can help reopen the artery and allow improved blood flow. Typically, balloon angioplasty is performed in conjunction with the placement of a stent or stent structure within the artery to help minimize restenosis. However, balloon angioplasty can stretch the artery and induce scar tissue formation, while stent placement can cut arterial tissue and also induce scar tissue formation. Scar tissue formation can lead to restenosis. In some cases, balloon angioplasty can also tear the vessel wall.

[0006] Plaque excision is another treatment for atherosclerosis and involves the mechanical removal (i.e., debulking) of plaque from the arterial wall using an endovascular device. Plaque excision devices allow plaque to be removed from the arterial wall, reducing the risk of stretching, cutting, or slicing the arterial wall and causing tissue damage that leads to restenosis. In some cases, plaque excision can be used to treat restenosis by removing scar tissue.

[0007] Unfortunately, some plaque resection devices are limited in structure and performance. For example, the cutting elements or components of some plaque resection devices cannot adequately treat total occlusion. Therefore, there is a need to provide improved plaque resection devices and methods. Summary of the Invention

[0008] This disclosure discloses a plaque removal device. The plaque removal device includes a handle configured for user operation. A conduit is coupled to the handle. The conduit includes an outer sheath and a drive shaft, the drive shaft being disposed within the outer sheath and rotatable relative to the outer sheath. A cutter assembly includes a housing coupled to and extending distally from the outer sheath, and the housing includes a housing support surface. The cutter assembly also includes a cutting element rotatably and translationally carried by the housing. The cutting element is coupled to and extends distally from the drive shaft. The cutting element includes at least one cutting blade configured to cut obstructive material as the cutting element rotates relative to the housing. The cutting element also includes a cutter support surface configured to engage the housing support surface. As the cutting element rotates relative to the housing and at least one cutting blade cuts obstructive material, the cutting element translates distally relative to the housing until the cutter support surface engages the housing support surface.

[0009] According to the plaque removal device described in the preceding paragraph, the drive shaft extends axially when the cutting element is translated distally relative to the housing, and shortens axially and translates the cutting element proximally relative to the housing when the cutter support surface engages the housing support surface.

[0010] According to any of the preceding paragraphs, the plaque removal device further includes a collar coupled to the housing, and when the cutter support surface engages the housing support surface, the drive shaft shortens axially and translates the cutting element proximally relative to the housing, such that the cutting element engages the collar.

[0011] According to any of the preceding paragraphs, the plaque removal device wherein the cutting element is capable of translating a distance of 0.010 inches to 0.035 inches relative to the housing.

[0012] According to any of the preceding paragraphs, the plaque removal device wherein the cutting element is capable of translating a distance of 0.015 inches to 0.030 inches relative to the housing.

[0013] According to any of the preceding paragraphs, the plaque removal device, wherein the cutting element is a proximal cutting element, wherein the cutter assembly further includes a distal cutting element, the distal cutting element being coupled to the proximal cutting element and being rotatable relative to the housing together with the proximal cutting element, and the distal cutting element including at least one cutting blade.

[0014] According to any of the preceding paragraphs, the plaque removal device wherein a cutter support surface is disposed between the distal and proximal portions of at least one cutting blade.

[0015] This disclosure also discloses a plaque removal device. The plaque removal device includes a handle configured for user operation. A conduit is coupled to the handle. The conduit includes an outer sheath and a drive shaft, the drive shaft being disposed within the outer sheath and rotatable relative to the outer sheath. A cutter assembly includes a housing coupled to and extending distally from the outer sheath, and the housing includes a cutter translation cavity. The cutter assembly also includes a cutting element rotatably and translationally carried by the housing. The cutting element is coupled to and extends distally from the drive shaft. The cutting element includes at least one cutting blade configured to cut occlusive material when the cutting element rotates relative to the housing. The cutting element also includes a cutter limiting portion rotatably received within the cutter translation cavity and translatable within the cutter translation cavity from a first position to a second position and vice versa. When the cutting element rotates relative to the housing and at least one cutting blade cuts the occlusive material, the cutter limiting portion rotates and translates within the cutter translation cavity from the first position to the second position, and the cutting element translates distally relative to the housing. When the cutter limiting part reaches the second position, the cutter limiting part translates from the second position to the first position, and the cutting element translates proximally relative to the housing.

[0016] According to the plaque removal device described in the preceding paragraph, the drive shaft extends axially when the cutting element is translated distally relative to the housing, and shortens axially when the cutter restraint portion reaches the second position, causing the cutting element to translate proximally relative to the housing.

[0017] According to any of the preceding paragraphs, the plaque removal device wherein, when the cutter limiting portion is translated from the first position to the second position, the cutting element is translated relative to the housing by a distance of 0.010 inches to 0.035 inches.

[0018] According to any of the preceding paragraphs, the plaque removal device wherein, when the cutter limiting portion is translated from the first position to the second position, the cutting element is translated relative to the housing by a distance of 0.015 inches to 0.030 inches.

[0019] According to any of the preceding paragraphs, the arterial resection device, wherein the cutting element is a proximal cutting element, wherein the cutter assembly further includes a distal cutting element, the distal cutting element being coupled to and rotatable with the proximal cutting element relative to the housing, and the distal cutting element including at least one cutting blade.

[0020] 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, and 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 ).

[0021] 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.

[0022] The term “means” as used herein shall be given the broadest possible interpretation in accordance with Section 112(f) of 35 U.S.SC. Therefore, claims containing the term “means” shall cover all structures, materials, or actions set forth herein, and all their equivalents. Furthermore, structures, materials, or actions, and their equivalents, shall include all that is described in the summary, description of the drawings, detailed description, abstract, and claims.

[0023] 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.

[0024] The foregoing is a simplified summary of this disclosure, intended to provide an understanding of some aspects of the disclosure. This summary is neither extensive nor exhaustive; it is not intended to identify key or essential elements of the disclosure, nor to depict its scope, but rather to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description given below. As will be understood, other aspects, embodiments, and configurations of the disclosure may utilize one or more features described above or in detail below, individually or in combination. Attached Figure Description

[0025] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate several examples of this disclosure. These drawings, together with the description, explain the principles of this disclosure. The drawings simply illustrate preferred and alternative examples of how this disclosure can be made and used, and should not be construed as limiting this disclosure to the examples shown and described. Other features and advantages will become apparent from the following more detailed description of various aspects, embodiments, and configurations of this disclosure, as illustrated in the accompanying drawings with reference to them.

[0026] Figure 1 This is a side view of a plaque excision system according to an embodiment of the present disclosure.

[0027] Figure 2A yes Figure 1 Detailed side view of the distal portion of the plaque excision system.

[0028] Figure 2B yes Figure 1 Detailed perspective view of the distal portion of the plaque excision system.

[0029] Figure 2C yes Figure 2A Detailed transverse cross-sectional view of the distal portion of the plaque excision system.

[0030] Figure 3A yes Figure 2A A detailed side view of the distal portion of the plaque removal system, wherein the housing is shown in a hidden line and the cutting element is shown in a first position relative to the housing.

[0031] Figure 3B yes Figure 2A A detailed side view of the distal portion of the plaque removal system, wherein the housing is shown in a hidden line and the cutting element is shown in a second position relative to the housing.

[0032] Figure 4A yes Figure 1 A perspective view of the distal cutting element of the plaque resection system.

[0033] Figure 4B yes Figure 4A Side view of the distal cut element.

[0034] Figure 4C It is along Figure 4B A cross-sectional view of the distal cut element taken from line 4C-4C.

[0035] Figure 5A yes Figure 1 A perspective view of the proximal cutting element of the plaque resection system.

[0036] Figure 5B yes Figure 5A Front view of the proximal cut element.

[0037] It should be understood that the accompanying drawings are not necessarily drawn to scale. In some cases, details that are not necessary for understanding this disclosure or that make other details difficult to understand may be omitted. Of course, it should be understood that this disclosure is not limited to the specific embodiments shown herein. Detailed Implementation

[0038] Before explaining any embodiments of this disclosure in detail, it should be understood that the application of this disclosure is not limited to the details of the construction and component arrangement set forth in the following description or shown in the following drawings. This disclosure can have other embodiments and can be practiced or performed in various ways. Furthermore, it should be understood that the wording and terminology used herein are for descriptive purposes and should not be considered limiting. The terms “comprising,” “including,” or “having,” and variations thereof, as used herein, are intended to cover the items listed thereafter and their equivalents, as well as additional items.

[0039] This disclosure generally relates to devices, systems, and methods for mechanical plaque resection. (Reference) Figure 1This illustration shows an exemplary embodiment of the plaque resection system described herein. The plaque resection system 100 includes an intravascular plaque resection device 102 and a guidewire 104, the plaque resection device 102 being disposed on the guidewire. In some embodiments, the guidewire 104 is silicon-coated or uncoated (bare), or otherwise does not contain a PTFE coating. Some embodiments of the plaque resection system according to this disclosure include a guidewire 104 with a PTFE coating, or some embodiments of the plaque resection system according to this disclosure lack a guidewire 104.

[0040] Continue to refer to Figure 1 The plaque resection device 102 generally includes a handle 106 and a catheter 108. The handle 106 is configured to be gripped and manipulated by a user (e.g., a medical professional) during plaque resection procedures. 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 within a blood vessel of a subject (e.g., a patient) during plaque resection procedures to facilitate the removal of occlusive material (e.g., plaque). In some embodiments, and as shown, the distal portion 110 of the catheter 108 has an arcuate shape or configuration. In some embodiments, the distal portion 110 of the catheter 108 normally has an arcuate configuration (“normally” is understood to mean that the catheter 108 is not subjected to any external contact forces, such as contact with the vessel wall), and is deflectable to other configurations. In other embodiments, the distal portion 110 of the catheter 108 normally has a straight shape or configuration and is deflectable to other configurations. In some embodiments, the catheter 108 is selectively rotatable about a catheter rotation axis 112 relative to the handle 106 to facilitate proper positioning and / or “sweeping” of the distal portion 110 of the catheter 108 during plaque resection procedures. In some embodiments, and as shown, the handle 106 carries a rotatable knob or dial 114 for selectively rotating the catheter 108 relative to the handle 106. The catheter 108 includes an outer sheath 116 coupled to a cutter assembly 118 extending distally from the outer sheath 116. The cutter assembly 118 will be described in further detail below.

[0041] Figure 2A-2C The distal portion 110 of catheter 108 is shown, which, among other components, includes an outer sheath 116 and a cutter assembly 118. The cutter assembly 118 includes a collar 200 coupled to and extending distally from the outer sheath 116. The cutter assembly 118 also includes a housing 202 coupled to and extending distally from the collar 200. The housing 202 rotatably carries the cutting element. See details. Figure 2B-2CThe housing 202 rotatably carries a first or distal cutting element 204 and a second or proximal cutting element 206. The rotation of the first cutting element 204 and the second cutting element 206 relative to the housing 202 about the axis of rotation 208 in the direction of rotation 210 causes the cutting elements 204, 206 to cut the obstructing material and deliver the obstructing material into the housing 202 (also known as the process of "debulking").

[0042] Still referencing Figure 2B-2C The first cutting element 204 extends generally distally from the second cutting element 206 and the housing 202. The first cutting element 204 includes a central opening 212 (see...). Figure 2C A guide wire is provided for connection to the second cutting element 206. The second cutting element 206 is generally disposed within the housing 202, and in some embodiments, as shown, may be completely disposed within the housing 202. The second cutting element 206 is also generally disposed near the first cutting element 204, although the second cutting element 206 includes a shaft or rod 214 received in a central opening 212. The rod 214 can be connected to the first cutting element 204 in various ways. For example, the rod 214 can be connected to the first cutting element 204 by welding. In some embodiments, as shown, the rod 214 extends distally relative to the first cutting element 204. The rod 214 includes an inner lumen 216 for receiving a guide wire (shown elsewhere).

[0043] For details, please refer to the following: Figure 2C The plaque removal device 102 also includes a rotatable drive shaft 218 that connects the first cutting element 204 and the second cutting element 206 to a prime mover (e.g., a motor carried by the handle 106 – not shown). That is, the prime mover rotates the drive shaft 218, which in turn rotates the first cutting element 204 and the second cutting element 206 to facilitate cutting the occlusive material and delivering it into the housing 202. In some embodiments, the cutter assembly 118 captures the cut-off occlusive material from the blood without using vacuum suction. In other embodiments, vacuum suction can help capture the cut-off occlusive material.

[0044] Continue to refer to Figure 2C In some embodiments, the plaque removal device 102 further includes an internal delivery unit 220 coupled to and rotating with a drive shaft 218. As the occlusive material is delivered into the cutter housing 202 by the first cutting element 204 and the second cutting element 206, the delivery unit 220 moves the cut-off occlusive material proximally through the conduit 108 for removal from the subject's body. In some embodiments, this delivery can occur without the aid of vacuum suction. In other embodiments, vacuum suction can assist in the delivery of the cut-off occlusive material.

[0045] The cutter assembly 118 includes features that allow the cutting elements 204, 206 to repeatedly translate distally and proximally or to oscillate translationally relative to the housing 202 during plaque resection surgery. In some cases, this movement allows the cutting elements 204, 206 to make relatively small, intermittent cuts in the occlusive material. This facilitates the efficient cutting and delivery of relatively small amounts of occlusive material, which in turn reduces the likelihood of blockage and allows for more efficient cutting of relatively hard occlusive material, such as calcium. More specifically, see reference... Figure 3A and 3B The housing 202 includes an internal housing support surface 300, and the second cutting element 206 includes one or more cutter support surfaces 302 (illustratively, four cutter support surfaces 302, three of which are located in...). Figure 3A and 3B (As can be seen in the image). When the cutter assembly 118 advances relative to the obstructing material and the cutting elements 204, 206 rotate relative to the housing 202 and cut the obstructing material, the cutting elements 204, 206, as described above, transport the obstructing material proximally. This action causes the cutting elements 204, 206 to move distally. That is, this action causes the cutting elements 204, 206 to move from... Figure 3A The position shown is towards Figure 3B The position is translated as shown, and the drive shaft 218 is axially extended or stretched. When the cutting elements 204 and 206 reach... Figure 3B In the indicated position, the cutter support surface 302 engages the housing support surface 300, which inhibits further distal translation of the cutting elements 204, 206 relative to the housing 202. Therefore, as long as the cutter assembly 118 advances at a sufficiently low speed (e.g., 1 mm / s or less), the cutting elements 204, 206 are prevented from cutting and delivering further occlusive material proximally. Thus, the cutting elements 204, 206 are not pushed distally by the occlusive material, and the drive shaft 218 is axially shortened or relaxed, allowing the cutting elements 204, 206 to... Figure 3B The position shown is towards Figure 3A The position is translated as shown. When cutting elements 204 and 206 reach... Figure 3A At the indicated position, the second cutting element 206 engages with the collar 200. The process is then repeated until the advance of the cutter assembly 118 or the rotation of the cutting elements 204, 206 is terminated.

[0046] During the above process, the cutting elements 204 and 206 can be translated a various distance relative to the housing 202. In some embodiments, the cutting elements 204 and 206 are translated a distance of 0.010 inches to 0.035 inches relative to the housing 202 during the above process. In some embodiments, the cutting elements 204 and 206 are translated a distance of 0.015 inches to 0.030 inches relative to the housing 202 during the above process.

[0047] The feature of the cutter assembly 118 that allows the cutting elements 204, 206 to repeatedly oscillate translationally relative to the housing 202 can be described in other ways. For example, the housing 202 may be described as including an internal cutter translation cavity 304, and the second cutting element 206 may be described as including a cutter restraint portion 306 rotatably received within the cutter translation cavity 304. The cutter restraint portion 306 is capable of moving from a first position (more specifically, such as...) within the cutter translation cavity 304. Figure 3A (As shown) translate to the second position (more specifically, as shown) Figure 3B (As shown), and vice versa. As the cutter assembly 118 advances relative to the obstructing material and the cutting elements 204, 206 rotate relative to the housing 202 and cut the obstructing material, the cutting elements 204, 206 deliver the obstructing material proximally as described above. This action causes the cutting elements 204, 206 to move from a first position to a second position, and the drive shaft 218 to extend or stretch axially. When the cutting elements 204, 206 reach the second position, the cutter restraint portion 306 reaches the distal portion 308 of the cutter translation chamber 304, which inhibits further distal translation of the cutting elements 204, 206 relative to the housing 202. Therefore, as long as the cutter assembly 118 advances at a sufficiently low speed (e.g., 1 mm / s or less), the cutting elements 204, 206 are prevented from cutting and delivering further obstructing material proximally. Therefore, the cutting elements 204 and 206 are not pushed distally by the obstructing material, the drive shaft 218 shortens or relaxes axially, and the cutting elements 204 and 206 translate from the second position to the first position. When the cutting elements 204 and 206 reach the first position, the second cutting element 206 reaches the proximal portion 310 of the cutter translation cavity 304. Then, this process is repeated until the forward movement of the cutter assembly 118 or the rotation of the cutting elements 204 and 206 is terminated.

[0048] Now for reference Figures 4A-4CThe first cutting element 204 includes one or more first or distal cutting grooves or blades extending distally relative to the housing 202. In some embodiments, as shown, the first cutting element 204 includes two distal cutting blades 400. In some embodiments, the first cutting element 204 includes a different number of cutting blades, for example, three, four, five, six, seven, eight, nine, ten, or more. In some embodiments, as shown, one or more of the distal cutting blades 400 extend helically relative to the axis of rotation 208 of the first cutting element 204 and the second cutting element 206.

[0049] For details, please refer to the following: Figure 4C In some embodiments, the distal cutting blade 400 has a positive rake angle 402. That is, the distal cutting blade 400 has a rake angle 402 that is measured between an imaginary radius 404 extending from the rotation axis 208 of the first cutting element 204 to the radially furthest edge 406 of the cutting blade 400 and a tangent 408 at the radially furthest edge 406 that is tangent to the inner surface 410 of the cutting blade 400. The direction of the rake angle 402 is the same as the direction of rotation 210 of the first cutting element 204 and the second cutting element 206 about the rotation axis 208. In some embodiments, the rake angle 402 is in the range of 40 degrees to 80 degrees. In some embodiments, the rake angle 402 is in the range of 45 degrees to 75 degrees. In some embodiments, the rake angle 402 is in the range of 40 degrees to 70 degrees. In some embodiments, the rake angle 402 is in the range of 45 degrees to 65 degrees. In some embodiments, the rake angle 402 is in the range of 50 degrees to 60 degrees. In some embodiments, the front angle 402 is essentially 55 degrees (i.e., 55 degrees ± 2.5 degrees).

[0050] Now for reference Figures 5A-5B The second cutting element 206 includes one or more second or proximal cutting grooves or blades 500. In some embodiments, the number of blades 500 in the second cutting element 206 is twice that of the first cutting element 204. In some embodiments, as shown, the second cutting element 206 includes four cutting blades 500. In some embodiments, as shown, the proximal cutting blades 500 extend helically relative to the axis of rotation 208 of the first cutting element 204 and the second cutting element 206. In some embodiments, specifically referring to... Figure 5BThe proximal cutting blade 500 has a negative rake angle 502. Alternatively, the proximal cutting blade 500 has a rake angle 502 that is measured between an imaginary radius 504 extending from the rotation axis 208 of the second cutting element to the radially furthest edge 506 of the cutting blade 500 and a tangent 508 at the radially furthest edge 506 that is tangent to the inner surface 510 of the cutting blade 500. The direction of the rake angle 502 is opposite to the direction of rotation 210 of the first cutting element 204 and the second cutting element 206 about the rotation axis 208. Alternatively, the inner surface 510 of the proximal cutting blade 500 may be tilted outward or forward from the cutting edge. In some embodiments, the rake angle 502 is in the range of 5 degrees to 45 degrees (also referred to as -5 degrees to -45 degrees). In some embodiments, the rake angle 502 is in the range of 6 degrees to 35 degrees (also referred to as -6 degrees to -35 degrees). In some embodiments, the front angle 502 is in the range of 8 to 24 degrees (also referred to as -8 to -24 degrees). In some embodiments, the front angle 502 is substantially 16 degrees (i.e., 16 degrees ± 2.5 degrees; also referred to as substantially -16 degrees (i.e., -16 degrees ± 2.5 degrees)).

[0051] In some embodiments, the positive rake angle 402 of the first cutting element 204 and the negative rake angle 502 of the second cutting element 206 are beneficial for improving cutting efficiency and / or suppressing blockage of occlusive material in the housing 202. More specifically, in some embodiments, the positive rake angle 402 of the first cutting element 204 is beneficial for cutting and conveying occlusive material toward the second cutting element 206, while the negative rake angle 502 of the second cutting element 206 is beneficial for moving the occlusive material radially outward and proximally toward the housing 202, thereby suppressing blockage of occlusive material in the housing 202.

[0052] In some embodiments, and as shown, a cutter support surface 302 is formed on each of the proximal cutting blades 500. In some embodiments, and as shown, the cutter support surface 302 may be disposed between the distal portion 512 and the proximal portion 514 of the proximal cutting blade 500. In such embodiments, the cutter support surface 302 may be disposed at any of a variety of locations between the distal portion 512 and the proximal portion 514 of the proximal cutting blade 500. In some embodiments, the cutter support surface 302 is disposed at other locations, such as the distal portion 512 of the proximal cutting blade 500.

[0053] In some embodiments, as shown, the cutting rod 214 further includes one or more cutting features 516 that facilitate the breaking down of occlusive material into smaller particles for capture and removal by the plaque removal system 100. In some embodiments, as shown, the cutting rod 214 includes two cutting features 516. In other embodiments, the cutting rod 214 includes a different number of cutting features 516 (e.g., one, three, four, five, six, seven, eight, nine, ten, or more). In some embodiments, the cutting features 516 are negative features (e.g., recesses formed on the surface of the cutting rod 214, as shown, or grooves formed on the surface of the cutting rod 214). In some embodiments, the cutting features 516 are positive features (e.g., ridges or protrusions extending from the surface of the cutting rod 214). In some embodiments, the cutting features 516 extend proximally from the leading end 518 of the cutting rod 214. In some embodiments, the cutting features 516 are configured to be separate from the leading end 518 and / or not extend proximally along the rod 214.

[0054] The foregoing discussion has been presented for purposes of illustration and description. The foregoing is not intended to limit this disclosure to the one or more forms disclosed herein. For example, in the preceding summary of the invention, various features of this disclosure have been combined in one or more aspects, embodiments, and / or configurations for the purpose of simplification. 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 approach to disclosure 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.

[0055] 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, to the skill and knowledge of those skilled in the art upon understanding this disclosure. It is intended to obtain rights to alternative aspects, embodiments, and / or configurations included within the permitted scope, including alternative, interchangeable, and / or equivalent structures, functions, scopes, or steps to the claimed structure, function, scope, or steps, whether such alternative, interchangeable, and / or equivalent structures, functions, scopes, or steps are disclosed herein, and it is not intended to publicly offer any patentable subject matter.

Claims

1. An atherectomy device comprising: a handle configured to be manipulated by a user; a catheter coupled to the handle, the catheter including an outer sheath and a drive shaft, wherein the drive shaft is disposed within the outer sheath and is rotatable relative to the outer sheath; and a cutter assembly including: a housing coupled to the outer sheath and extending distally therefrom, the housing including a housing support surface; a cutting element rotatably and translationally carried by the housing, the cutting element coupled to the drive shaft and extending distally therefrom, the cutting element including: at least one cutting blade configured to cut obstructive material as the cutting element is rotated relative to the housing; and a cutter support surface configured to engage the housing support surface; wherein, as the cutting element is rotated relative to the housing and the at least one cutting blade cuts obstructive material, the cutting element is translated distally relative to the housing until the cutter support surface engages the housing support surface, and as the cutter support surface engages the housing support surface, the drive shaft is axially shortened and translates the cutting element proximally relative to the housing, thereby allowing the cutting element to be repeatedly translated distally and proximally relative to the housing.

2. The atherectomy device of claim 1, wherein, The drive shaft is axially lengthened as the cutting element is translated distally relative to the housing.

3. The atherectomy device of claim 1, wherein, The cutter assembly further includes a ferrule coupled to the housing, and as the cutter support surface engages the housing support surface, the drive shaft is axially shortened and translates the cutting element proximally relative to the housing such that the cutting element engages the ferrule.

4. The atherectomy device of claim 1, wherein, The cutting element is translatable relative to the housing a distance of 0.010 inch to 0.035 inch.

5. The atherectomy device of claim 1, wherein, The cutting element is translatable relative to the housing a distance of 0.015 inch to 0.030 inch.

6. The atherectomy device of claim 1, wherein, The cutting element is a proximal cutting element, wherein the cutter assembly further includes a distal cutting element coupled to the proximal cutting element and rotatable with the proximal cutting element relative to the housing, and the distal cutting element includes at least one cutting blade.

7. The atherectomy device of claim 1, wherein, The cutter support surface is disposed between a distal end portion and a proximal end portion of the at least one cutting blade.

8. An atherectomy device comprising a handle configured to be manipulated by a user; a catheter coupled to the handle, the catheter including an outer sheath and a drive shaft, wherein the drive shaft is disposed within the outer sheath and is rotatable relative to the outer sheath; and a cutter assembly including: a housing coupled to the outer sheath and extending distally therefrom, the housing including a cutter translation lumen; a cutting element rotatably and translationally carried by the housing, the cutting element coupled to the drive shaft and extending distally therefrom, the cutting element including: at least one cutting blade configured to cut obstructive material as the cutting element is rotated relative to the housing; and a cutter support surface configured to engage the housing support surface; a cutter limiting portion rotatably received within the cutter translation lumen and capable of translating within the cutter translation lumen from a first position to a second position and vice versa; wherein, when the cutting element is rotated relative to the housing and the at least one cutting blade cuts occlusive material, the cutter limiting portion rotates within the cutter translation lumen and translates from the first position to the second position, and the cutting element translates distally relative to the housing, and when the cutter limiting portion reaches the second position, the cutter limiting portion translates from the second position to the first position, and the drive shaft axially shortens and translates the cutting element proximally relative to the housing, thereby allowing the cutting element to repeatedly translate distally and proximally relative to the housing.

9. The atherectomy device of claim 8, wherein, the drive shaft axially lengthens when the cutting element translates distally relative to the housing.

10. The atherectomy device of claim 8, wherein, the cutting element translates a distance of 0.010 inches to 0.035 inches relative to the housing when the cutter limiting portion translates from the first position to the second position.

11. The atherectomy device of claim 8, wherein, the cutting element translates a distance of 0.015 inches to 0.030 inches relative to the housing when the cutter limiting portion translates from the first position to the second position.

12. The atherectomy device of claim 8, wherein, the cutting element is a proximal cutting element, wherein the cutter assembly further comprises a distal cutting element coupled to the proximal cutting element and capable of rotating with the proximal cutting element relative to the housing, and the distal cutting element comprises at least one cutting blade.

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