Patent Publication Number: US-2022211409-A1

Title: Atherectomy devices including positive and negative rake angle cutting blades

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     None. 
     FIELD OF THE DISCLOSURE 
     The devices and methods described herein generally relate to treatment of occluded body lumens, such as the removal of occlusive material from a blood vessel or other body parts. 
     BACKGROUND 
     Peripheral and interventional cardiology is a medical specialty that relates to treatment of various forms of cardiovascular disease, including coronary artery disease and peripheral vascular disease. Coronary artery disease and peripheral vascular disease can arise due to the narrowing of the arteries by atherosclerosis (also called arteriosclerosis). Coronary artery disease generally affects arteries of the heart-arteries that carry blood to cardiac muscles and surrounding tissue. Peripheral vascular disease refers to various diseases of the vascular system outside the heart and brain, which carries blood, for example, to the legs. 
     Atherosclerosis commonly affects the medium and large arteries, and may occur when fat, cholesterol, and other substances build up on the walls of arteries and form fleshy or hard/calcified structures called plaques/lesions. As plaque forms within an arterial wall, the artery may narrow and become less flexible, which may make it more difficult for blood to flow therethrough. In the peripheral arteries, the plaque is typically not localized, but can extend in length along the axis of the artery for as much as 10 mm or more (in some instance up to 400 mm or more). 
     Pieces of plaque can break off and move through the affected artery to smaller blood vessels, which may in some instances block them and may result in tissue damage or tissue death (embolization). In some cases, the atherosclerotic plaque may be associated with a weakening of the wall of the affected artery, which can lead to an aneurysm. Minimally invasive surgeries may be performed to remove plaque from arteries in an effort to alleviate or help prevent the complications of atherosclerosis. 
     A number of interventional surgical methodologies may be used to treat atherosclerosis. In balloon angioplasty, for example, a physician may advance a collapsed, intravascular balloon catheter into a narrowed artery, and may inflate the balloon to macerate and/or displace plaque against the vessel wall. A successful angioplasty may help reopen the artery and allow for improved blood flow. Often, balloon angioplasty is performed in conjunction with the placement of a stent or scaffold structure within the artery to help minimize re-narrowing of the artery. Balloon angioplasty, however, can stretch the artery and induce scar tissue formation, while the placement of a stent can cut arterial tissue and also induce scar tissue formation. Scar tissue formation may lead to restenosis of the artery. In some instances, balloon angioplasty can also rip the vessel wall. 
     Atherectomy is another treatment methodology for atherosclerosis, and involves the use of an intravascular device to mechanically remove (that is, debulk) plaque from the wall of the artery. Atherectomy devices may allow for the removal of plaque from the wall of an artery, reducing the risk of stretching, cutter, or dissecting the arterial wall and causing tissue damage that leads to restenosis. In some instances, atherectomy may be used to treat restenosis by removing scar tissue. 
     Unfortunately, some atherectomy devices suffer from structural and performance limitations. For example, the cutting elements or assemblies of some atherectomy devices cannot adequately treat total occlusions. Accordingly, it is desirable to provide improved atherectomy devices and methods. 
     SUMMARY 
     The present disclosure presents an atherectomy device. The atherectomy device includes a handle configured to be manipulated by a user. A catheter is coupled to the handle. The catheter includes an outer sheath and a drive shaft, wherein the drive shaft is disposed within and rotatable relative to the outer sheath. A cutter assembly is coupled to and extends distally relative to the outer sheath. The cutter assembly includes a housing coupled to and extending distally from the outer sheath. A proximal cutting element is rotatably carried by the housing, and the proximal cutting element is coupled to and extends distally from the drive shaft. The proximal cutting element includes at least one proximal cutting blade, and the at least one proximal cutting blade has a negative rake angle. A distal cutting element is rotatable with the proximal cutting element relative to the housing. The distal cutting element includes at least one distal cutting blade, and the at least one distal cutting blade has a positive rake angle. 
     The atherectomy device according to the previous paragraph, wherein the proximal cutting element comprises a plurality of proximal cutting blades, each of the plurality of proximal cutting blades having the negative rake angle. 
     The atherectomy device according to any of the previous paragraphs, wherein the distal cutting element comprises a plurality of distal cutting blades, each of the plurality of distal cutting blades having the positive rake angle. 
     The atherectomy device according to any of the previous paragraphs, wherein the negative rake angle is in a range of 8 degrees to 24 degrees. 
     The atherectomy device according to any of the previous paragraphs, wherein the negative rake angle is substantially 16 degrees. 
     The atherectomy device according to any of the previous paragraphs, wherein the positive rake angle is in a range of 40 degrees to 70 degrees. 
     The atherectomy device according to any of the previous paragraphs, wherein the positive rake angle is substantially 55 degrees. 
     The present disclosure also presents an atherectomy device. The atherectomy device includes a handle configured to be manipulated by a user. A catheter is coupled to the handle. The catheter includes an outer sheath and a drive shaft, wherein the drive shaft is disposed within and rotatable relative to the outer sheath. A cutter assembly is coupled to and extends distally relative to the outer sheath. The cutter assembly includes a housing coupled to and extending distally from the outer sheath. A proximal cutting element is rotatably carried by the housing about a rotational axis in a rotational direction. The proximal cutting element is coupled to and extends distally from the drive shaft. A proximal cutting element is carried by the housing, and the proximal cutting element is configured to cut occlusive material when rotating relative to the housing about a rotational axis in a rotational direction. The proximal cutting element is coupled to and extends distally from the drive shaft. The proximal cutting element includes at least one proximal cutting blade. The at least one proximal cutting blade has a first rake angle, and the first rake angle extends from (i) a radius from the rotational axis to a most radially distant edge of the at least one proximal cutting blade to (ii) a tangent from an inner face of the at least one proximal cutting blade at the most radially distant edge. The first rake angle is in the opposite direction as the rotational direction. A distal cutting element is coupled to the proximal cutting element. The distal cutting element is configured to cut occlusive material when rotating with the proximal cutting element relative to the housing about the rotational axis in the rotational direction. The distal cutting element includes at least one distal cutting blade. The at least one distal cutting blade has a second rake angle, and the second rake angle extends from (iii) a radius from the rotational axis to a most radially distant edge of the at least one distal cutting blade to (iv) a tangent from an inner face of the at least one distal cutting blade at the most radially distant edge of the at least one distal cutting blade. The second rake angle is in the same direction as the rotational direction. 
     The atherectomy device according to the previous paragraph, wherein the proximal cutting element comprises a plurality of proximal cutting blades, each of the plurality of proximal cutting blades having the first rake angle. 
     The atherectomy device according to any of the previous paragraphs, wherein the distal cutting element comprises a plurality of distal cutting blades, each of the plurality of distal cutting blades having the second rake angle. 
     The atherectomy device according to any of the previous paragraphs, wherein the first rake angle is in a range of 8 degrees to 24 degrees. 
     The atherectomy device according to any of the previous paragraphs, wherein the first rake angle is substantially 16 degrees. 
     The atherectomy device according to any of the previous paragraphs, wherein the second rake angle is in a range of 40 degrees to 70 degrees. 
     The atherectomy device according to any of the previous paragraphs, wherein the second rake angle is substantially 55 degrees. 
     The atherectomy device according to any of the previous paragraphs, wherein the housing comprises an inner surface, and the inner surface comprises at least one shearing element. 
     The atherectomy device according to any of the previous paragraphs, wherein the inner surface comprises a plurality of shearing elements. 
     The atherectomy device according to any of the previous paragraphs, wherein the at least one shearing element comprises a channel. 
     The phrases “at least one”, “one or more”, and “and/or” are open-ended expressions that are both conjunctive and disjunctive in operation. 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” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together. When each one of A, B, and C in the above expressions refers to an element, such as X, Y, and Z, or class of elements, such as X 1 -X n , Y 1 -Y m , and Z 1 -Z o , the phrase is intended to refer to a single element selected from X, Y, and Z, a combination of elements selected from the same class (for example, X 1  and X 2 ) as well as a combination of elements selected from two or more classes (for example, Y 1  and Z o ). 
     The term “a” or “an” entity refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” may be used interchangeably herein. It is also to be noted that the terms “comprising”, “including”, and “having” may be used interchangeably. 
     The term “means” as used herein shall be given its broadest possible interpretation in accordance with 35 U.S.C. Section 112(f). Accordingly, a claim incorporating the term “means” shall cover all structures, materials, or acts set forth herein, and all of the equivalents thereof. Further, the structures, materials or acts and the equivalents thereof shall include all those described in the summary, brief description of the drawings, detailed description, abstract, and claims themselves. 
     It should be understood that every maximum numerical limitation given throughout this disclosure is deemed to include each and every lower numerical limitation as an alternative, as if such lower numerical limitations were expressly written herein. Every minimum numerical limitation given throughout this disclosure is deemed to include each and every higher numerical limitation as an alternative, as if such higher numerical limitations were expressly written herein. Every numerical range given throughout this disclosure is deemed to include each and every narrower numerical range that falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein. 
     The preceding is a simplified summary of the disclosure to provide an understanding of some aspects of the disclosure. This summary is neither an extensive nor exhaustive overview of the disclosure and its various aspects, embodiments, and configurations. It is intended neither to identify key or critical elements of the disclosure nor to delineate the scope of the disclosure but to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description presented below. As will be appreciated, other aspects, embodiments, and configurations of the disclosure are possible utilizing, alone or in combination, one or more of the features set forth above or described in detail below. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings are incorporated into and form a part of the specification to illustrate several 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 may be made and used and are not to be construed as limiting the disclosure to only the illustrated and described examples. Further features and advantages will become apparent from the following, more detailed, description of the various aspects, embodiments, and configurations of the disclosure, as illustrated by the drawings referenced below. 
         FIG. 1  is a side view of an atherectomy system according to an embodiment of the present disclosure. 
         FIG. 2A  is a detail side view of a distal portion of the atherectomy system of  FIG. 1 . 
         FIG. 2B  is a detail perspective view of the distal portion of the atherectomy system of  FIG. 1 . 
         FIG. 2C  is a detail transverse sectional view of the distal portion of the atherectomy system of  FIG. 2A . 
         FIG. 3A  is a perspective view of a distal cutting element of the atherectomy system of  FIG. 1 . 
         FIG. 3B  is a side view of the distal cutting element of  FIG. 3A . 
         FIG. 3C  is a cross sectional view of the distal cutting element along line  3 C- 3 C of  FIG. 3B . 
         FIG. 4A  is a perspective view of a proximal cutting element of the atherectomy system of  FIG. 1 . 
         FIG. 4B  is a front view of the proximal cutting element of  FIG. 4A . 
         FIG. 5A  is a perspective view of a cutter housing of the atherectomy system of  FIG. 1 . 
         FIG. 5B  is a front view of the cutter housing of  FIG. 5A . 
     
    
    
     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 disclosure or that render other details difficult to perceive may have been omitted. It should be understood, of course, that the disclosure is not necessarily limited to the particular embodiments illustrated herein. 
     DETAILED DESCRIPTION 
     Before any embodiments of the disclosure are explained in detail, it is to be understood that the 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 disclosure is capable of other embodiments and of being practiced or of 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. 
     The present disclosure relates generally to devices, systems, and methods for mechanical atherectomy. Referring to  FIG. 1 , there is shown an exemplary embodiment of the atherectomy systems described herein. The atherectomy system  100  includes an intravascular atherectomy device  102  and a guide wire  104  over which the atherectomy device  102  may be deployed. In some embodiments, the guide wire  104  is silicon-coated or non-coated (bare), or otherwise free of a PTFE coating. Atherectomy systems according to some embodiments of the present disclosure comprise a guide wire  104  that includes a PTFE coating, or atherectomy systems according to some embodiments of the present disclosure lack a guide wire  104 . 
     With continued reference to  FIG. 1 , the atherectomy device  102  generally includes a handle  106  and a catheter  108 . The handle  106  is configured to be grasped and manipulated by a user (for example, a medical professional) during an atherectomy procedure. The catheter  108  is coupled to and extends distally relative to the handle  106 . The catheter  108  is configured to be positioned in the vasculature of a subject (for example, a patient) during an atherectomy procedure to facilitate removal of occlusive material (for example, plaque) therefrom. In some embodiments and as illustrated, 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  normally has a curved configuration (“normally” being understood as the catheter  108  not being subjected to any external contact forces due to, for example, contact with blood vessel walls) and may be deflected to other configurations. In other embodiments, the distal portion  110  of the catheter  108  normally has a straight shape or configuration and may be deflected to other configurations. In some embodiments, the catheter  108  is selectively rotatable about a catheter  108  rotational axis  112  relative to the handle  106  to facilitate appropriately positioning and or “sweeping” the distal portion  110  of the catheter  108  during an atherectomy procedure. In some embodiments and as illustrated, 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 , and the outer sheath  116  couples to a cutter assembly  118  that extends distally therefrom. The cutter assembly  118  is described in further detail below. 
       FIGS. 2A-2C  illustrate the distal portion  110  of the catheter  108 , including, among other components, the outer sheath  116  and the cutter assembly  118 . The cutter assembly  118  includes a ferrule  200  that couples to the outer sheath  116  and extends distally therefrom. The cutter assembly  118  further includes a housing  202  that couples to the ferrule  200  and extends distally therefrom. The housing  202  rotatably carries cutting elements. Referring specifically to  FIGS. 2B-2C , the housing  202  rotatably carries a first, or distal, cutting element  204  and a second, or proximal, cutting element  206 . Rotation of the first cutting element  204  and the second cutting element  206  about a rotation axis  208  in a rotational direction  209  relative to the housing  202  causes the cutting elements  204 ,  206  to cut occlusive material and convey the occlusive material into the housing  202  (a process also referred to as “debulking”). 
     Still referring to  FIGS. 2B-2C , the first cutting element  204  generally extends distally from the second cutting element  206  and the housing  202 . The first cutting element  204  includes a central opening  210  (see  FIG. 2C ) for coupling to the second cutting element  206 . The second cutting element  206  is generally disposed within the housing  202  and, in some embodiments and as illustrated, may be completely disposed within the housing  202 . The second cutting element  206  is also generally disposed proximally from the first cutting element  204 , although the second cutting element  206  includes a shaft or stem  212  that is received in the central opening  210 . The stem  212  may couple to the first cutting element  204  in various manners. For example, the stem  212  may couple to the first cutting element  204  via welding. In some embodiments and as illustrated, the stem  212  extends distally relative to the first cutting element  204 . The stem  212  includes an inner lumen  214  for receiving a guide wire (shown elsewhere). 
     Referring specifically to  FIG. 2C , the atherectomy device  102  further includes a rotatable drive shaft  216  that couples the first cutting element  204  and the second cutting element  206  to a prime mover (for example, a motor carried by the handle  106 —not shown). That is, the prime mover rotates the drive shaft  216 , which in turn rotates the first cutting element  204  and the second cutting element  206  to facilitate cutting occlusive material and conveying the occlusive material into the housing  202 . In some embodiments, the cutter assembly  118  captures the cut occlusive material from the blood without the use of vacuum aspiration. In other embodiments, vacuum aspiration may assist capture of the cut occlusive material. 
     With continued reference to  FIG. 2C , in some embodiments, the atherectomy device  102  also includes an internal conveyor  218  that is coupled to and rotates with the drive shaft  216 . As occlusive material is conveyed into the cutter housing  202  by the first cutting element  204  and the second cutting element  206 , the conveyor  218  displaces the cut occlusive material proximally through the catheter  108  for discharge outside the subject&#39;s body. In some embodiments, this conveyance may occur without the use of vacuum aspiration assistance. In other embodiments, vacuum aspiration may assist conveyance of the cut occlusive material. 
     Referring now to  FIGS. 3A-3C , the first cutting element  204  includes one or more first, or distal, cutting flutes or blades  300  that extend distally relative to the housing  202 . In some embodiments and as illustrated, the first cutting element  204  includes two cutting blades  300 . In some embodiments and as illustrated, one or more of the first cutting blades  300  extend helically relative to the rotation axis  208  of the first cutting element  204  and the second cutting element  206 . In some embodiments and referring specifically to  FIG. 3C , one or more of the first cutting blades  300  have a positive rake angle  302 . That is, one or more of the first cutting blades  300  has a rake angle  302  that is measured between an imaginary radius  304  extending from the rotation axis  208  of the first cutting element  204  to a most radially distant edge  306  of the cutting blade  300  and a tangent  308  from an inner face  310  of the cutting blade  300  at the most radially distant edge  306 . The rake angle  302  is in the same direction as the rotational direction  209  of the first cutting element  204  and the second cutting element  206  about the rotation axis  208 . In some embodiments, the rake angle  302  is in a range of 30 degrees to 80 degrees. In some embodiments, the rake angle  302  is in a range of 35 degrees to 75 degrees. In some embodiments, the rake angle  302  is in a range of 40 degrees to 70 degrees. In some embodiments, the rake angle  302  is in a range of 45 degrees to 65 degrees. In some embodiments, the rake angle  302  is in a range of 50 degrees to 60 degrees. In some embodiments, the rake angle  302  is substantially 55 degrees (that is, 55 degrees±2.5 degrees). 
     Referring now to  FIGS. 4A-4B , the second cutting element  206  includes one or more second, or proximal, cutting flutes or blades  400 . In some embodiments, the second cutting element  206  has two times the number of blades  400  as the first cutting element  204 . In some embodiments and as illustrated, the second cutting element  206  includes four cutting blades  400 . In some embodiments and as illustrated, one or more of the second cutting blades  400  extend helically relative to the rotation axis  208  of the first cutting element  204  and the second cutting element  206 . In some embodiments and referring specifically to  FIG. 4B , one or more of the second cutting blades  400  have a negative rake angle  402 . Stated another way, one or more of the second cutting blades  400  has a rake angle  402  that is measured between an imaginary radius  404  extending from the rotation axis  208  of the second cutting element to a most radially distant edge  406  of the cutting blade  400  to a tangent  408  from an inner face  410  of the cutting blade  400  at the most radially distant edge  406 . The rake angle  402  is in the opposite direction as the rotational direction  209  of the first cutting element  204  and the second cutting element  206  about the rotation axis  208 . Stated yet another way, the inner face  410  of one or more of the second cutting blade  400  may slant outward or forward of the cutting edge. In some embodiments, the rake angle  402  is in a range of 5 degrees to 45 degrees (also referred to as −5 degrees to −45 degrees). In some embodiments, the rake angle  402  is in a range of 6 degrees to 35 degrees (also referred to as −6 degrees to −35 degrees). In some embodiments, the rake angle  402  is in a range of 8 degrees to 24 degrees (also referred to as −8 degrees to −24 degrees). In some embodiments, the rake angle  402  is substantially 16 degrees (that is, 16 degrees±2.5 degrees; also referred to as substantially −16 degrees (that is, −16 degrees±2.5 degrees)). 
     In some embodiments, the positive rake angle  302  of the first cutting element  204  and the negative rake angle  402  of the second cutting element  206  facilitate improved cutting efficiency and/or inhibit clogging of occlusive material in the housing  202 . More specifically, in some embodiments the positive rake angle  302  of the first cutting element  204  facilitates cutting and conveying occlusive material toward the second cutting element  206  and the negative rake angle  402  of the second cutting element  206  facilitates displacing occlusive materially radially outwardly toward the housing  202  and proximally, thereby inhibiting clogging of occlusive material in the housing  202 . 
       FIGS. 5A-5B  illustrate the housing  202  of the cutter assembly  118 . In some embodiments and as illustrated, the inner surface  500  of the housing  202  includes one or more shearing elements  502  that further macerate occlusive material. In some embodiments and as illustrated, the housing  202  includes five shearing elements  502 . In other embodiments, the housing  202  includes a different number of shearing elements  502  (for example, one, two, three, four, six, seven, eight, nine, ten, or more shearing elements  502 ). In some embodiments, the shearing elements  502  are negative features (for example, channels formed on the inner surface  500  of the housing  202 , as illustrated). In some embodiments, the shearing elements  502  are positive features (for example, ridges or protrusions extending from the inner surface  500  of the housing  202 ). In some embodiments and as illustrated, the shearing elements  502  extend in a direction substantially parallel to the rotation axis  208  (shown elsewhere—that is, parallel±10 degrees). In some embodiments, one or more of the shearing elements  502  do not extend in a direction substantially parallel to the rotation axis  208  (for example, one or more of the shearing elements  502  may extend helically relative to the rotation axis  208 ). 
     The foregoing discussion has been presented for purposes of illustration and description. The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Summary for example, various features of the disclosure are grouped together in one or more aspects, embodiments, and/or configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and/or configurations of the disclosure may be combined in alternate aspects, embodiments, and/or configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and/or configuration. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure. 
     Moreover, though the description has included description of one or more aspects, embodiments, and/or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the disclosure, for example, as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and/or configurations to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.