JP7042861B2 - Abrasive elements for rotary atherectomy system - Google Patents

Description

[0001] The present disclosure generally covers systems, devices and methods for atherectomy. More specifically, the present disclosure relates to novel shapes of abrasive elements used in atherectomy procedures.

[0002] Atherosclerosis is a major cause of coronary heart disease. Atherosclerosis occurs when lipids, cholesterol and / or other substances accumulate in the walls of blood vessels to form hard structures called plaques and / or atherosclerotic lesions. Over time, these plaques and / or lesions can grow to a size that clogs and / or completely occludes blood vessels.

[0003] Rotary atherectomy is a technique used, for example, to polish calcified arterial lesions. Also, rotary atherectomy devices and rotary atherectomy procedures can be referred to as rotary angioplasty devices and / or rotary angioplasty procedures. One type of rotary atherectomy device is known as orbital atherectomy device , eg, U.S. Patent Application Publication No. 2014/0081298 and U.S. Patent Application Publication No. 2014/0316449. It is described in the book etc.

[0004] The device for rotary atherectomy can include a polishing element attached to the proximal portion of a rotatable flexible drive shaft. The rotatable flexible drive shaft can be carried to the desired location on the guide wire and / or through the sheath. Abrasive elements may be referred to as burrs, crowns and / or bead edges. The drive shaft can be rotated at high speeds (eg, between 20,000 and 160,000 rpm). As the abrasive element rotates, it can be advanced on the stenotic lesion or plaque to contact the obstructed tissue and / or plaque. In this way, the polishing element rubs the lesion surface and polishes the lesion into very small particles. These small particles can be removed from this site by blood flow.

[0005] The devices, systems and methods of the present disclosure have several features, none of which alone contribute to their desired properties. Next, its superior features are briefly discussed without limiting the scope of the invention described below, which is represented by the claims. After considering this discussion, especially after reading the section "Forms for Carrying Out the Invention", how the features of this disclosure provide some advantages over other rotary atherectomy systems. Will be understood.

[0006] The present disclosure is directed to novel bead shapes that can provide improved polishing efficiency in atherectomy procedures. One embodiment is a high speed rotary atherectomy device for opening a stenosis in an artery having a lumen extending through the interior. The device can be equipped with a flexible elongated rotatable drive shaft. The device can also include a guide wire having a maximum diameter smaller than the diameter of the lumen. In such an embodiment, the drive shaft may be able to advance on the guide wire. Polishing elements can be placed on the drive shaft. The polishing element can have a first center of mass offset in the first radial direction from the center of mass of the drive shaft. The polishing element can have a second center of mass offset in the second radial direction from the center of mass of the drive shaft. The second center of mass may be positioned proximal to the first center of mass. The second radial direction may be predominantly the opposite of the first radial direction. In some embodiments, the polishing element is eccentric.

[0007] The polishing element can have a proximal end and a distal end. The polishing element can have a total center of mass located between the proximal and distal ends. In some embodiments, the total center of mass can be located at the midpoint between the proximal and distal ends. The distal end can have a first radial offset mass center from the mass center of the drive shaft. The proximal end can have a second radial offset mass center from the mass center of the drive shaft. The second radial direction may be the direction opposite to the first radial direction. In some embodiments, the abrasive element comprises a lumbar region located between the proximal and distal ends of the abrasive element. In some embodiments, at least a portion of the outward facing surface is roughened, i.e., rough compared to the outer surface of the drive shaft. In some embodiments, the center of mass contains a material that is heavier than the rest of the polishing element. In other words, the center of mass of the polishing element can include a material having a density higher than the density of the material of the rest of the polishing element. In some embodiments, the polishing element is arranged on the drive shaft so that the polishing element can move radially with respect to the drive shaft. For one embodiment, it is not unthinkable that the abrasive element comprises a distal portion, a central portion and a proximal portion. In such embodiments, each of these portions can have a radially offset mass center, even if the radial directions are more or less the same with respect to the distal and proximal portions. good. For the central portion, this shift may be in the direction approximately opposite to the offset direction with respect to the distal and proximal portions. The combined distal and proximal mass centers can be proximal or distal to the central mass center when viewed from the longitudinal direction of the drive shaft. However, it is not unthinkable that the combined distal and proximal mass centers coincide with the central mass center with respect to the longitudinal position along the drive axis. The center of mass may be balanced or slightly unbalanced with respect to the drive shaft.

[0008] Another embodiment is a high speed rotary atherectomy device for opening a stenosis in an artery having a lumen extending through the interior. The device can be equipped with a flexible elongated rotatable drive shaft that is sized and molded for insertion into the lumen. The device can also include a body. The body can have a radially expandable structure in place between its distal and proximal ends. At least two polishing elements may be placed on the outer surface of the body or distributed around a radially expandable structure, thereby at least two polishing elements when rotating the drive shaft. The elements are separated from each other and radially increase the dimensions of the radially expandable structure between them. The body can have slots that extend through the sides of the body at a location between its distal and proximal ends. Proximal and distal ends can be coupled to a flexible elongated rotatable drive shaft. The body and drive shaft can be forwardable on the guide wire. The body can be provided with an elongated tube. Abrasive elements can be placed on either side of the slot. When the drive shaft is rotated, at least two polishing elements can be pulled apart from each other and the width of the slot between them can be increased. In some embodiments, the polishing element and the body may be made of a different material, i.e., the polishing element may be made of a different material than the material on which the body is formed. In some embodiments, the at least two polishing elements are placed in different longitudinal locations along the body. In some embodiments, the rod extends from the proximal end of the slot to the distal end of the slot. The polishing element can be provided with a rough outer surface as compared to the outer surface of the drive shaft. It is not unthinkable that embodiments include three polishing elements or more. These can be evenly distributed around a radially expandable structure. The centers of mass may be balanced with respect to the drive shaft or may be slightly out of balance with each other.

[0009] Another embodiment comprises a method of excising a lesion in a blood vessel. This method can comprise a step of advancing the guide wire through the blood vessel. The sheath can be advanced on the guide wire. The sheath can have a proximal end, a distal end, and a lumen extending through the interior. The sheath can include an introducer sheath. In aspects, the sheath comprises a catheter having a lumen extending through the interior. The method can also include a step of advancing the flexible drive shaft through the sheath on a guide wire. The drive shaft can have a proximal end, a distal end, and a polishing element attached to the distal end. The polishing element can have a first diameter. The method can also include a step of advancing the polishing element out of the distal end of the sheath and a step of increasing the first diameter of the polishing element by rotating the drive shaft. The method can also comprise the step of excising the lesion. In some embodiments, the polishing element is suppressed to a second diameter smaller than the first diameter as the polishing element is advanced through the sheath. This diameter may be an effective diameter.

[0010] These and other features, embodiments, and advantages of the invention disclosed herein are illustrations of specific embodiments intended to illustrate, but not to limit, the invention. See below as described below. Additionally, throughout the figure, the same reference numbers are used to indicate the same components of the illustrated embodiments. The following is a brief description of each of the figures.

[0011] FIG. 1 is a schematic perspective view of an atherectomy system that can be used with the polishing elements disclosed herein, the atherectomy system may include a drive system coupled to a drive shaft. The polishing element can be coupled to the distal portion of the drive shaft. [0012] FIG. 1A is an enlarged perspective view of a polishing element coupled to the distal portion of the drive shaft shown in FIG. [0013] FIG. 3 is an enlarged perspective view of the polishing element of FIGS. 1 and 1A with the drive shaft removed. [0014] It is a side view of the polishing element of FIG. [0015] It is a top view of the polishing element of FIG. 2. [0016] It is sectional drawing of the polishing element of FIG. 4 along the line 5-5. [0017] It is a front view of the polishing element of FIG. [0018] It is a rear view of the polishing element of FIG. [0019] FIG. 2 is a schematic cross-sectional view of the polishing element of FIG. 2 coupled to a drive shaft and urged against the inner wall of the sheath. [0020] FIG. 6 is a cross-sectional view taken around line 8B-8B of FIG. 8A. [0021] FIG. 8A is the same as FIG. 8A, except that the polishing element has been removed from the sheath and returned to a non-bulging position. [0022] A cross-sectional view taken around line 8D-8D in FIG. 8C. [0023] The same figure as in FIG. 8A, except that the polishing element is coupled to the drive shaft in an alternative manner, and as shown, the polishing element is urged against the inner wall of the sheath. There is. [0024] FIG. 6 is a cross-sectional view taken around line 8F-8F of FIG. 8E. [0025] FIG. 8E is the same as FIG. 8E, except that the polishing element has been removed from the sheath and returned to a non-bulging position. [0026] FIG. 6 is a cross-sectional view taken around line 8H-8H of FIG. 8G. [0027] It is the same figure as FIG. 8G when the polishing element is rotated at high speed, and as shown, at least a part of the polishing element can move with respect to the drive shaft. [0028] It is a cross-sectional view cut around the line 8J-8J of FIG. 8I. [0029] FIG. 3 is a schematic cross-sectional view of a blood vessel showing exemplary operation of the polishing elements disclosed herein. [0030] A schematic side view of a polishing element according to another embodiment, which is similar to the polishing element of FIG. 2 but does not have an oblique internal lumen extending through it. [0031] FIG. 10A is the same as FIG. 10A, except that the polishing element is shown as being urged against the inner wall of the sheath. [0032] A perspective view of the polishing element according to another embodiment, wherein the polishing element comprises a tube with a slot and two polishing protrusions located on the outer surface of the tube and on either side of the slot. , Equipped with. [0033] It is an exploded view of the polishing element of FIG. [0034] It is a perspective view of the tube with a slot of FIG. [0035] It is a side view of the tube with a slot of FIG. [0036] It is a top view of the tube with a slot of FIG. [0037] FIG. 14 is a front view of the slotted tube of FIG. [0038] It is a perspective view of one of the polishing protrusions of FIG. [0039] It is a top view of the polishing protrusion of FIG. [0040] It is a bottom view of the polishing protrusion of FIG. [0041] It is a side view of the polishing protrusion part of FIG. [0042] It is a front view of the polishing protrusion of FIG. [0043] It is a side view of the polishing element of FIG. [0044] FIG. 11 is a top view of the polishing element of FIG. [0045] It is a cross-sectional view of the polishing element of FIG. [0046] It is the same as FIG. 22, and shows the polishing element in the non-suppressed state. [0047] FIG. 3 is a side view of the polishing element of FIG. 11 positioned in the sheath and in a restrained state. [0048] It is a side view of the polishing element of FIG. 11 when the polishing element is rotated at high speed, and as shown, the polishing protrusion opens a slot when the polishing element is rotated at high speed. It is a cross-sectional view of FIG. 26 cut out around lines 28-28. [0050] FIG. 25 is a cross-sectional view taken along the line 29-29. [0051] FIG. 27 is a cross-sectional view taken along the line 30-30. [0052] A perspective view of the polishing element according to another embodiment, which is similar to the embodiment of FIG. 11 except that the two polishing protrusions overlap at least partially with the slot. [0053] It is a side view of the polishing element of FIG. [0054] FIG. 3 is a top view of the polishing element of FIG. 31. [0055] FIG. 3 is a cross-sectional view of the polishing element of FIG. 32 cut out around lines 34-34. [0056] It is a side view of the polishing element of FIG. 31 positioned in the sheath. [0057] FIG. 35A is a cross-sectional view taken along the line 35B-35B. [0058] It is a side view of the polishing element of FIG. 31 when the polishing element is rotated at a high speed. FIG. 36A is a cross-sectional view taken along the line 36B-36B. [0059] A perspective view of the polishing element according to another embodiment, wherein the embodiment is similar to the embodiment of FIG. 11 except that the rod is positioned on a slot in a slotted tube. , May be referred to as an embodiment with double slots. Although not shown, a double-slotted version of the device of FIG. 31 is also conceivable. [0060] It is an exploded view of the polishing element of FIG. 37. [0061] It is a perspective view of the tube with a double slot of FIG. 38. [0062] It is a side view of the tube with a double slot of FIG. 38. [0063] It is a top view of the tube with a double slot of FIG. 38. [0064] It is a front view of the tube with a double slot of FIG. 40. It is a side view of the polishing element of FIG. 37, and shows the polishing element in a non-suppressing state. [0066] It is a side view of the polishing element of FIG. 37 positioned in the sheath in the restrained state. [0067] It is a side view of the polishing element of FIG. 37 when the polishing element is rotated at a high speed. [0068] FIG. 44 is a cross-sectional view taken along the line 46-46. [0069] FIG. 43 is a cross-sectional view taken along the line 47-47. [0070] FIG. 45 is a cross-sectional view of FIG. 45 cut around lines 48-48. It is a perspective view of the polishing element according to another embodiment, and the embodiment of FIG. 49 is similar to the embodiment of FIG. 11, but includes a polishing protrusion having a shape different from that of FIG. [0072] It is a side view of the polishing element of FIG. 49. [0073] It is a top view of the polishing element of FIG. 50. [0074] FIG. 5 is a cross-sectional view of the polishing element of FIG. 50 cut out around lines 52-52. [0075] FIG. 5 is a perspective view of the polishing element according to a different embodiment, and the embodiment of FIG. 53 is similar to the embodiment of FIG. 49, except that the polishing protrusions are offset from each other along the longitudinal axis. .. [0076] It is a side view of the polishing element of FIG. 53. [0077] It is a top view of the polishing element of FIG. 54. [0078] FIG. 5 is an axial direction view of the polishing element of FIG. 54.

[0079] The following description and examples show preferred embodiments of the rotary atherectomy device of the invention disclosed in the context of use in an atherectomy procedure. More specifically, these embodiments relate, for example, to a rotary atherectomy device and related techniques used to resect a calcified lesion in a blood vessel.

[0080] The following description and accompanying drawings illustrating and showing the preferred embodiments are made to demonstrate some possible configurations. These configurations can be incorporated such that the atherectomy device and / or system has the various aspects and features disclosed. Those skilled in the art are not limited to any particular atherectomy system or device, wherein the disclosed embodiments and features may include one or more of the embodiments and features of the invention disclosed herein. You will understand that. In addition, the disclosed embodiments can be used with a variety of commercially available devices in a variety of medical procedures.

[0081] Certain implementations of the subject matter described herein may be performed to realize one or more of the following potential benefits: The atherectomy device described herein is specifically configured to more efficiently remove calcified lesions within a blood vessel. In some embodiments, the device comprises a polishing element, the polishing element being configured to move at least a portion thereof away from the central axis of the drive shaft. In some embodiments, the device comprises a distal polishing element, which is configured to expand when it is rotated at high speed. In this way, the abrasive elements disclosed herein can extend further out of the drive shaft and press against the lesion. In other words, the polishing elements disclosed herein have a larger polishing area and / or scraping area than the other polishing elements.

[0082] In some embodiments, the polishing element can effectively allow a larger polishing element to be fitted into a standard lumen when delivered to a location of interest. .. For example, the polishing element may be configured to be radially suppressed when placed in the lumen and then expanded radially as it exits the lumen. The polishing element may be further configured to expand further radially as it is rotated. In this way, the abrasive elements disclosed herein can open the stenotic lesion to a diameter substantially larger than the maximum diameter of the abrasive element and / or the sheath through which the abrasive element is carried. .. Thus, the polishing elements disclosed herein can have an improved polishing range, an increased scraping area, reduced treatment time, and / or more effectively restenosis. Can be prevented.

[0083] Various embodiments are then described with reference to specific embodiments or embodiments selected for exemplary purposes. It will be appreciated that the intent and scope of the atherectomy system disclosed herein is not limited to any selected form. Further, it should be noted that the figures provided herein are not drawn in a particular ratio or scale and that many changes can be made to the exemplary embodiments. A brief introduction to some of the features common to the described embodiments of the atherectomy system is described below.

[0084] The following coordinate terms are used to aid in the description of these components of the atherectomy system. The "longitudinal axis" is substantially parallel to the elongated sides of the polishing element disclosed herein. See, for example, FIG. The "diametrical axis" is perpendicular to the longitudinal axis and extends radially.

[0085] In addition, as used herein, "longitudinal" refers to a direction substantially parallel to the longitudinal axis, and "diametrical" means substantially parallel to the radial axis. The direction parallel to. The term "axis direction" may be used herein and is a synonym for the term "longitudinal" as used herein.

[0086] Also, the terms "proximal" and "distal" used to describe the atherectomy system of the present invention are used in line with the description of exemplary uses (specific illustrations). Will be done. Therefore, proximal and distal are used with reference to the handle of the atherectomy system.

[0087] The terms "upper", "lower", "upper", "bottom", "lower surface", "upper surface" and the like used to describe the atherectomy system of the present invention are illustrated. Used with reference to the orientation of the embodiment. For example, the term "top surface" can be used to describe a portion of the polishing element located above the longitudinal and / or radial axis that passes through the center of the polishing element. The term "bottom surface" can be used to describe a portion of the polishing element located below the longitudinal and / or radial axis that passes through the center of the polishing element.

[0088] FIG. 1 shows a system for rotary atherectomy according to one embodiment. The system 1 includes a drive system 3 configured to rotate the flexible drive shaft 5 at high speeds (eg, 20,000 to 160,000 rpm). The drive system 3 may include an electric motor. The drive system 3 is Boston Scientific Rotablator, Cardiovascular.
Systems Inc. (“CSI”) Stealth, CSI Diamondback360, and / or may be equipped with or designed to be substantially similar to other similar devices. The drive shaft 5 can be propellable on a guide wire (not shown) or through a sheath. The drive shaft 5 may include a proximal end coupled to the drive system 3 and a distal end inserted into the patient. The drive shaft 5 can extend, for example, through the lumen of an artery. In some embodiments, the rotary atherectomy system 1 comprises a sheath. In some embodiments, a catheter with a lumen extending through the interior is attached to the proximal end of the drive shaft. In such an embodiment, the drive shaft 5 can extend through the lumen of the catheter.

As shown in FIG. 1A, the polishing element 200 may be coupled to the distal portion of the drive shaft 5. In some embodiments, the polishing element 200 is coupled in a location proximal to the distal end of the drive shaft 5. For example, the polishing element 200 may be coupled to the drive shaft 5 at a location approximately 20 mm proximal to the distal end of the drive shaft 5. In some embodiments, the polishing element 200 is located approximately 10 mm proximal to the distal end of the drive shaft 5. The drive shaft 5 may include a wound wire. In another embodiment, the drive shaft 5 comprises a tube.

[0090] The polishing element 200 can include a proximal end 213 and a distal end 211. The polishing element may have a length between about 1 and 25 mm. In another embodiment, the polishing element is about 1 to 15 mm long. In some embodiments, the polishing element is about 6 mm long. The polishing elements disclosed herein can be made of any suitable material or combination thereof. For example, the polishing element or a portion thereof may be made of surgical stainless steel, titanium, tungsten, nitinol, or the like. In some embodiments, the polishing element is solid as opposed to hollow. In some embodiments, the abrasive element comprises a raised lumbar region located between the proximal and distal ends. In some embodiments, the polishing element has an eccentric shape.

[0091] Moving to FIG. 2, an enlarged view of the polishing element 200 according to the embodiment of FIGS. 1 and 1A is shown. As shown, the polishing element 200 comprises a substantially cylindrical bead 201 having an inclined end 205 and a lumen 203 extending through the interior. The polishing element 200 may be attached to a flexible drive shaft 5 that is rotated at high speed by an electric motor. Generally, the polishing element 200 is coupled to the drive shaft 5, whereby the polishing element 200 and the drive shaft 5 rotate integrally about a longitudinal axis passing through the center of the drive shaft 5. That is, the polishing element 200 may be coupled to the drive shaft 5, whereby the polishing element 200 is suppressed from moving with respect to the drive shaft 5. In another embodiment, the polishing element 200 is configured to be restrained from moving longitudinally with respect to the drive shaft 5, but not crossing and / or laterally longitudinally. In some embodiments, the polishing element 200 moves in concert with at least a portion of the drive shaft 5 located within the polishing element 200.

[0092] In some embodiments, at least a portion of the drive shaft 5 positioned within the polishing element 200 is welded to at least a portion of the inner surface of the lumen 203. In certain embodiments, the polishing element 200 is welded to the entire inner surface of lumen 203. In another embodiment, the polishing element 200 is crimped so that at least a portion of the lumen 203 engages at least a portion of the drive shaft 5 positioned within the lumen 203. In some embodiments, the proximal portion of the lumen is welded to the proximal portion of the drive shaft and the distal portion of the lumen is welded to the distal portion of the drive shaft. For example, in some embodiments, a laser is used to melt at least a portion of the polishing element 200 to at least a portion of the drive shaft 5.

[0093] The polishing element 200 can include a roughened outer surface 207. The roughened outer surface 207 can improve the polishing ability of the polishing element 200. In some embodiments, the roughened outer surface 207 comprises diamond particles deposited on one or more of the outer surfaces of the abrasive element 200. The diameter of these particles may be about 20 μm. The polishing element 200 is shown as having a roughened overall outer surface, but in some embodiments the outer surface is roughened to a smaller extent than the overall outer surface. The roughened outer surface 207 can be similar to sandpaper and can improve the ability of the abrasive element 200 to excise the lesion.

[0094] The shape of the example of the polishing element 200 is further shown in FIGS. 3-7. As best shown in FIG. 5, the lumen 203 extending through the polishing element 200 extends obliquely within the substantially cylindrical bead 201. In other words, as shown in FIG. 5, lumen 203 extends from the left bottom corner of the distal end 211 of the cylindrical bead 201 to the upper right corner of the proximal end 213 of the cylindrical bead 201. In this way, when the polishing element 200 is attached to the flexible drive shaft 5 positioned in the lumen 203, for example as shown in FIG. 1A, the tilted end 205 of the polishing element 200 is polished. It extends radially away from the flexible drive shaft 5 more than the other outer surfaces of the element 200. In this way, the ends of the distal 211 and the proximal 213 can have a local center of mass, which is diagonally opposite to each other and from the center of the longitudinal axis of the drive shaft 5. Exists at a distance. For example, as shown in FIG. 1A, the local mass center of the distal end 211 of the polishing element 200 is located on the upper surface of the drive shaft 5 and is the local mass center of the proximal end 213 of the polishing element 200. Is located on the lower surface of the drive shaft 5.

[0095] In some embodiments, the beveled end 205 is shaped to improve the traceability of the abrasive element 200 through the vasculature. For example, one or more angled surfaces can improve the ability of the polishing element 200 to be inserted through winding and / or narrow passages. The sloping end 205 can also help the abrasive element 200 facilitate passage of calcified material within the blood vessel.

[0096] A substantially cylindrical bead 201 is shown, but other shapes are also conceivable. For example, in some embodiments, the polishing element 200 may comprise a lumbar region that is larger or smaller in diameter than the rest of the substantially cylindrical bead 201.

[0097] As shown in FIG. 5, the angle of lumen 203 can create two staggered local centers of mass located near the distal and proximal ends of the abrasive element 200. .. That is, due to the oblique lumen 203, the mass present below the longitudinal axis extending through the center of the polishing element 200 is greater at the proximal end 213 than at the distal end 211. Similarly, due to the oblique lumen 203, the mass present above the longitudinal axis extending through the center of the abrasive element 200 is greater at the distal end 211 than at the proximal end 213.

[0098] In other embodiments, the distal and / or proximal ends may be made from a material heavier than the material of the rest of the polishing element 200. For example, in some embodiments, at least a portion of the volume disposed under the sloping end 205 and / or the sloping end 205 is made of a material heavier than the material of the rest of the polishing element 200. For example, in some embodiments, at least a portion of the distal end 211 and the proximal end 213 of the substantially cylindrical bead 201 is made of tungsten, while the rest of the substantially cylindrical bead 201. Part is made of steel. In this way, the heavier material of the distal end 211 and the proximal end 213 can further disperse the two masses, which are eccentrically located at both ends and sides of the polishing element 200. do. In some embodiments, at least a portion of the polishing element 200 is hollow. For example, in some embodiments, at least a portion of the distal end and at least a portion of the proximal end comprises at least one hollow portion.

[0099] During operation, the distribution of mass within the polishing element 200 can change the polishing angle of the polishing element 200 with respect to the longitudinal axis extending through the lumen of the blood vessel. For example, at low speeds, the sides of the substantially cylindrical bead 201 can come into contact with and excise the material deposited on the walls of the vascular lumen. At high speeds, the displaced local center of mass can cause the abrasive element 200 to wobble with respect to the longitudinal axis extending through the blood vessel. In this way, the inclined end 205 of the polishing element 200 can also contact and excise the material deposited on the wall of the vascular lumen. In some embodiments, this variable polishing angle of the polishing element 200 can enhance the effectiveness of the atherectomy device.

[0100] In some embodiments, the mass dispersion within the abrasive element 200 can increase the static friction of the abrasive element 200 with the material deposited on the walls of the vascular lumen. For example, the mass dispersion within the polishing element 200 can reduce the degree to which the polishing element bounces away from the material with which it comes into contact when rotated. Therefore, in some embodiments, the mass dispersion of the abrasive element 200 can enhance the effectiveness of the atherectomy device. The relative size and shape of the polishing element 200 can also be modified to increase static friction. For example, in some embodiments, the polishing element 200 comprises one or more protrusions and / or irregularities, which increases the static friction of the polishing element with the material to be excised.

[0101] As best shown in FIGS. 2, 4 and 5, the polishing element 200 has a proximal notch 223 communicating with the proximal end of lumen 203 and a distal end of lumen 203. It can also be provided with a distal notch 221 that communicates with. Therefore, lumen 203 opens upward and distally, and downwards and proximally. Proximal notch 223 and distal notch 221 can provide a welded area. That is, the weld can be at least partially disposed within the proximal notch 223 and / or the distal notch 221 to secure the polishing element 200 to the drive shaft 5. In some embodiments, the proximal notch 223 and the distal notch 221 maximize the distance between the two staggered local mass centers while maintaining a low profile while carrying the abrasive element 200. Can help you to. In some embodiments, the notch can remove mass from a portion of the proximal and distal ends to create two staggered local centers of mass.

[0102] In a particular embodiment, the polishing element 200 can move in the axial direction at an angle with respect to the longitudinal axis of the drive shaft 5. In other words, at least a portion of the drive shaft 5 can pass through at least a portion of the distal notch 221 and / or the proximal notch 223. Therefore, the polishing element 200 is coupled to the drive shaft 5 so as to be restrained from moving in the longitudinal direction with respect to the drive shaft 5, but moves in the longitudinal direction intersecting and / or laterally with respect to the drive shaft 5. Doing is not suppressed. Thus, when the drive shaft 5 and the polishing element 200 are rotated about a longitudinal axis, the proximal and / or distal ends of the polishing element 200 can be further separated from the central axis of the drive shaft 5. .. In another embodiment, the polishing element 200 is attached to the drive shaft 5 so as to be restrained from moving with respect to the drive shaft 5. In certain embodiments, the polishing element 200 can be coupled to the drive shaft 5 so that the distal end of the polishing element 200 can move radially with respect to the drive shaft.

[0103] FIGS. 8A-8D show exemplary positions of the polishing element 200 attached to the flexible drive shaft 5. As shown in FIGS. 8A to 8D, the welded portion 800 can fix the polishing element 200 to the drive shaft 5. Welds may be placed at or near the proximal and distal ends of the polishing element 200. As shown in FIGS. 8B and 8D, the weld 800 may be arranged around the circumference of the lumen 203 and the drive shaft 5.

[0104] In FIGS. 8A-8B, the polishing element 200 attached to the flexible drive shaft 5 is shown at a restraining position within the sheath 801. The polishing element 200 can move to a non-suppressing position when advanced and out of the sheath, as shown in FIGS. 8C-8D. That is, the effective diameter of the polishing element 200 increases when the polishing element 200 exits the sheath 801 (eg, length d ₂ in FIG. 8D is greater than d ₁ in FIG. 8B). In some embodiments, the abrasive element 200 has an unsuppressed or unfolded profile that is 10-60% larger, 35-45% larger, or at least 40% larger than the suppressed profile. The portion of the polishing element 200 that overlaps the portion of the drive shaft 5 may be fixed together, whereby the polishing element 200 and the portion of the drive shaft 5 within the polishing element 200 move together.

[0105] FIGS. 8E-8J show exemplary positions of the polishing element 200 attached to the flexible drive shaft 5 according to another embodiment. 8E-8J show the polishing element 200 attached to the flexible drive shaft 5 by the weld 800. Although the mounting means are described as welds, other mounting means may be used. For example, in some embodiments, an adhesive is used to attach the polishing element 200 to the flexible drive shaft 5. As shown, the weld 800 is located approximately in the center of the polishing element 200 and couples the outer surface of the drive shaft 5 to the inner surface of the lumen 203. However, the weld 800 can cover more or less than the area shown. For example, in some embodiments, the weld 800 couples the entire length of the lumen 203 to the drive shaft 5. In another embodiment, the weld 800 does not contact the entire surface of the diameter of the lumen 203. As discussed above, the weld 800 prevents the polishing element 200 from moving longitudinally with respect to the drive shaft 5. Depending on the type, size and / or location of the weld 800, the polishing element 200 may or may not move radially with respect to the drive shaft 5 during rotation.

[0106] In certain embodiments, the weld 800 allows the abrasive element 200 to pivot around the weld 800. That is, a portion of the polishing element 200 can move and / or rotate radially. In another embodiment, the weld 800 is located at the proximal and distal ends of the polishing element as described above. In some embodiments, a portion of the polishing element 200 that overlaps a portion of the drive shaft 5 is fixed together so that the polishing element 200 and the portion of the drive shaft 5 within the polishing element 200 work together. Moving.

[0107] In FIGS. 8E-8F, the polishing element 200 attached to the flexible drive shaft 5 is shown in the restraint position within the sheath 801. The polishing element 200 can move to a non-suppressing position when it is advanced out of the sheath as shown in FIGS. 8G-8H. That is, the effective diameter of the polishing element 200 increases when the polishing element 200 exits the sheath 801 (for example, d ₃ in FIG. 8J is longer than d ₂ in FIG. 8H). In some embodiments, the abrasive element 200 has an unsuppressed or unfolded profile that is 10-60% larger, 35-45% larger, or at least 40% larger than the suppressed profile. In certain embodiments, when the polishing element 200 and the flexible drive shaft 5 are rotated as shown in FIGS. 8I-8J, centrifugal force exerts a flexible drive shaft on the tilted end 205 of the polishing element 200. Further away from the central axis of 5. Therefore, the polishing range of the polishing element 200 can be further increased, and the polishing element 200 can have an even larger effective diameter when rotated (eg, d ₃ of FIG. 8J is FIG. 8H. The length is larger than d ₂ of). Therefore, within a tightly closed blood vessel, the centrifugal force acting on the local mass center of the distal and proximal ends of the abrasive element 200 allows the abrasive element 200 to have a larger effective diameter and therefore. The effectiveness of the device is improved and / or the treatment time is shortened.

[0108] FIG. 9 schematically illustrates an exemplary operation of the polishing elements disclosed herein. When the vessel 900 is opened by the rotating abrasive elements 200, 300, 1000, the shape of the abrasive element (s) can also trigger and / or facilitate a second action. The small track 920 represents the path that the outermost radial surface of the polishing element can follow as the drive shaft 5 and the polishing element are rotated. The small track 920 can represent the path of the grind element 200 as it wobbles with respect to the longitudinal axis through its center. In other words, the effective diameter of the small track 920 can be increased by the relative movement of the polishing element with respect to the longitudinal axis through the center of the polishing element and / or by the physical deformation of the polishing element. In some embodiments, the small orbital 920 may increase in effective diameter as the polishing element is rotated. In certain embodiments, for example, the effective diameter of the polishing element can have a first diameter at a first rotation speed and a second effective diameter at a second rotation speed. The second effective diameter can be larger in size than the first effective diameter if the second rotation speed is greater than the first rotation speed. In some embodiments, for example, if the polishing element 200 is attached to the drive shaft 5 to allow relative radial movement, this relative radial movement further increases the size of the small trajectories. Can be made to. Thus, the operation of the drive shaft 5 and the polishing element can extend the scraping area and / or the polishing range of the polishing element beyond the small track 920.

[0109] In certain embodiments, for example, if the polishing elements have ends with local mass centers dispersed opposite to each other and away from the central axis of the drive shaft 5. Due to the rotation of the drive shaft 5, the drive shaft 5 and the polishing element can produce a large orbital 910 by centrifugal force (especially after sufficient space is created in the lesion at high rotational speeds, eg at 30,000 rpm and above). can. Accordingly, the polishing elements disclosed herein may be configured such that the scraping area and / or polishing range of the polishing element is extended beyond the small track 920.

[0110] FIGS. 10A-10B show the polishing element 300 according to a similar embodiment as described above. As shown, the polishing element 300 has two local mass centers. The two local centers of mass are spaced apart (with approximate locations at 301 and 303) and located at diagonal corners offset from the center of the flexible drive shaft 5. The polishing element 300 can comprise a substantially straight lumen extending from the proximal end 313 to the distal end 311 of the polishing element 30. The polishing element 300 may have a substantially cylindrical shape. The polishing element 300 may be attached to the drive shaft 5 as shown in FIG. 10A, whereby the distal center of mass 301 is located above the longitudinal center of the drive shaft 5 and the proximal mass center 303 is the drive. It is located below the center of the longitudinal direction of the shaft 5. Therefore, when the polishing element 300 is rotated, the polishing range of the polishing element is increased beyond the small trajectories as described above. Further, as shown in FIG. 10B, the polishing element 300 has an effective diameter larger than the sheath 801 from which the polishing element 300 is developed. The polishing element 300 is provided with a curved edge, which can improve the slidability of the device through winding paths and / or through the lumen.

[0111] FIGS. 11-30 show the polishing element 400 according to another embodiment. For example, as shown in FIG. 11, the polishing element 400 comprises a slotted tube 409 having at least two protrusions extending from the polishing element 400. As shown, the protrusion comprises a bipartite bead 405 attached to the polishing element 400. The polishing element 400 can have a distal end 411 and a proximal end 413. At least a portion of the bead 405 comprises a roughened outer surface 407. Similar to the embodiments described above, the polishing element 400 may be coupled to the proximal portion of the flexible drive shaft 5. As described in more detail, the slotted tube 409 may be configured to compress, whereby the polishing element 400 passes through the sheath for low profile transfer and expands during high speed rotation. The polishing range can be increased.

[0112] FIG. 12 shows an exploded view of the polishing element 400. As shown, the bipartite bead 405 comprises two molded halves with a roughened outermost surface 407. As shown, the bipartite bead 405 is formed such that the surface of the bead 405 facing the slotted tube 409 is in contact with the curved outer surface of the slotted tube 409. The bipartite bead 405 has a shape such that the bead does not extend and / or cover any portion of the slot 416. The bead 405 can be coupled to the slotted tube 409 by any suitable means. For example, the bead 405 can be welded, glued and / or fused to the slotted tube 409. The bead 405 can be made of the same or different material as the tube 409. In some embodiments, the slotted tube 409 and the bead 405 are made as an integral piece.

[0113] As shown in FIGS. 13-16, the slotted tube 409 can comprise a substantially cylindrical tube with a lumen 433 penetrating longitudinally. The slot 416 may have a substantially rectangular shape and may extend radially through the tube 409 to communicate with the lumen 433. Tube 409 can be made from one or more materials that are flexible enough to contract and / or expand under applied force. In some embodiments, the tube 409 may be configured to shrink in size when an external force is applied and substantially return to its original form and shape when the external force is removed. In some embodiments, the tube 409 can be configured to stretch when an external force is applied and substantially return to its original form and shape when the external force is removed.

[0114] FIGS. 17-21 further show the bead 405. As shown, the bead 405 comprises a curved lower surface 440 having a shape that contacts the unslotted portion of the slotted tube 409. The bead 405 comprises two sloping transitions 445 and a central substantially cylindrical portion having a roughened surface 407. In some embodiments, the bead 405 has a shape that is thicker in a region further away from slot 416 of the slotted tube 409. In some embodiments, the bead 405 is formed from a material that is relatively harder and / or denser than the tube 409.

[0115] As shown in FIG. 22, when the bipartite bead 405 is coupled to the slotted tube 409, the mass of each half of the bead 405 is from the longitudinal center of the flexible drive shaft 5. Be separated. Therefore, the polishing element 400 includes two local center of mass offset from the longitudinal center of the flexible drive shaft 5. The local center of mass of the polishing element 400 is radially spaced apart, unlike the embodiments shown in FIGS. 1-10B, but the local center of mass is not longitudinally separated from each other. However, in some embodiments, the polishing element 400 may be configured such that this local center of mass is offset both radially and longitudinally. For example, the two bead elements 409 may not be symmetrically attached to the slotted tube 409. In other words, the first bead element may be coupled to a slotted tube 409 such that its most proximal end is positioned on the most proximal end of slot 416, while the first bead element may be coupled to a slotted tube 409. , The second bead element may be coupled such that its most distal end is positioned on the most distal end of slot 416.

[0116] As also shown in FIG. 22, the drive shaft 5 does not need to pass the entire length of the polishing element 400. Therefore, the proximal end of the polishing element 400 may be fixed to the distal end of the first drive shaft 5, and the distal end of the polishing element 400 is close to the portion of the second drive shaft 5. It may be fixed to the position end. With the drive shaft removed from the center of the polishing element 400, the polishing element can be compressed and the two bead elements 409 can move towards each other, whereby the polishing element has a low profile. Can be taken. In another embodiment, the drive shaft 5 passes through the entire length of the polishing element.

[0117] FIGS. 22-24 show that the polishing element 400 can generally include a central polishing area 450 and proximal and distal mounting areas 455. The central polishing area 450 may be coupled to the proximal and distal mounting areas 455 by the tube gap area 460. Proximal and distal mounting areas 455 are portions of slotted tube 409 secured to a flexible drive shaft 5 extending through the lumen 433 of slotted tube 409. Proximal and distal mounting areas 455 can be provided with welds and / or crimps or any other suitable fixing means. Therefore, the proximal and distal mounting areas 455 are restrained from moving away from the flexible drive shaft 5. In the embodiment in which the drive shaft 5 passes through the entire length of the polishing element, the drive shaft may be fixed to the mounting area 455, but not to the tube gap region 460 and the central polishing area 450. Therefore, the tube gap region 460 and the central polishing region 450 are unrestrained and can move towards and / or away from the flexible drive shaft 5.

[0118] FIGS. 25-30 show exemplary positions of the polishing element 400 attached to the flexible drive shaft 5. The polishing element 400 is shown in a stationary configuration in FIGS. 25 and 29. The radial thickness of this unsuppressed quiescent device is labeled as dl. The polishing element 400 is shown in a restrained form in FIGS. 26 and 28. In FIGS. 26 and 28, the polishing element 400 is positioned within the sheath 801. In this restrained form, the radial thickness of the device is the thickness of the sheath 801 and is labeled as d2. As shown, the radial thickness d2 in the suppressed form is smaller than the radial thickness d1 in the non-suppressed form. As shown in FIGS. 26 and 28, in the restrained position, the slotted tube is compressed so that the slot has a width smaller than the width in the non-suppressed form of FIGS. 25 and 29. In other words, the slotted tube 409 allows the polishing element 400 to be compressed radially. In this way, the polishing element 400 can have an effective diameter larger than the sheath 801 in which it is carried.

[0119] In some embodiments, the polishing element 400 spontaneously returns to its non-suppressed form in a relatively short time after being removed from the sheath 801. In other words, the material of the polishing element 400 is selected so that the slotted tube 409 bounces back to its non-suppressing form as soon as the passive inhibition applied by the sheath is removed. In another embodiment, the polishing element 400 is rotated at a relatively low speed (eg, 5000 rpm or less) and then returns to its non-suppressed form.

[0120] In FIGS. 27 and 30, the polishing element 400 is shown in an expanded configuration. For example, when the polishing element 400 is rotated at high speed, centrifugal force causes the polishing element 400 to expand as the slotted tube 409 expands. That is, since the bipartite bead 405 has a local mass center dispersed away from the central axis of the slotted tube 409 and the drive shaft 5, rotation also pulls the bead portion 405 away from the tube axis by centrifugal force. Therefore, the tube with slot 409 is expanded. Therefore, when the polishing element 400 is rotated at high speed (eg, about 90,000 rpm or more), the polishing element 400 can be expanded to a diameter d3 larger than d1 and d2. Therefore, the polishing range of the polishing element 400 extends beyond its non-suppressing diameter d2. Although d3 is shown to be significantly larger than d2, it is understood that the diameter of the polishing element 400 does not actually have to increase to that extent when the device is rotated. The relative sizes of d1 to d3 are merely to aid an easy understanding of the functionality of the device and do not indicate the actual percentage of expansion in use.

[0121] In some embodiments, the polishing element 400 spontaneously returns to its non-suppressed form in a relatively short time after it ceases to rotate. In other words, the material of the polishing element 400 is selected so that the slotted tube 409 returns to the non-suppressed form as soon as the drive shaft 5 rests. In another embodiment, the polishing element 400 returns to a substantially non-suppressed form as soon as the drive shaft 5 rests, and shifts to a suppressed form when pulled into the sheath 801.

[0122] The polishing element 400 has been shown and described as a two-part bead 405 coupled to a slotted tube 409, but a single structure is also conceivable. Thus, in some embodiments, the slotted tube 409 can have a wall thicker than the walls at its proximal and distal ends in the central region of the slotted tube 409. At least a portion of the slotted tube can comprise a polished outer surface. In other words, the thickness of the walls on both sides of the slot 416 increases from the two ends of the slotted tube 409 and can reach the peak of the thickness at the center of the slotted tube 409. Changes in wall thickness can create two local mass centers dispersed away from the central axis of the slotted tube 409 and the drive shaft 5. Changes in wall thickness can form one or more protrusions extending radially outward from the center of the polishing element. Therefore, when the device is rotated at high speed, centrifugal force causes the two local center of mass to pull open the slot, causing the polishing element 400 to expand radially. Similarly, materials of different masses can be used to create slotted tubes that expand when the slotted tube is rotated at high speed.

[0123] FIGS. 31-36 show the polishing element 500 according to another embodiment. The polishing element 500 is configured such that the bipartite bead 505 is configured to extend at least partially over slot 416 of the slotted tube 409 when the polishing element 500 is unrestrained and stationary. It is the same as the polishing element 400.

[0124] For example, as shown in FIGS. 31-34, the bipartite rim 505 substantially extends over the slot of slot 416 of the slotted tube 409, whereby the bipartite rim only in the small void 515. Separate 505. For example, as shown in FIGS. 35A-35B, the bipartite rims 505 are pressed against each other when restrained by the sheath 801 as in the embodiment shown in FIG. 26. Similar to the embodiments described above in FIGS. 27 and 30, when the polishing elements 500 are rotated at high speeds as shown in FIGS. 36A-36B, the bead 505s are separated from each other by centrifugal force. Forced to be separated. Therefore, the diameter d3 of the working polishing element 500 is larger than the diameter d1 when the device is in its non-suppressed form.

[0125] FIGS. 37-47 show the polishing element 600 according to another embodiment. For example, as shown in FIGS. 37-40, the polishing element 600 comprises a support rod 520 in which the slotted tube 509 extends on both sides of the slotted tube 509 over the longitudinal length of the slot, thereby providing two openings. It is similar to the polishing element 400 described above, except that it produces 516 and 517. The support rod 520 can help cure the polishing element 600. As shown in FIG. 42, the slotted tube 509 comprises a substantially cylindrical tube having a lumen 433 penetrating longitudinally.

[0126] FIGS. 43-48 show various forms of the polishing element 600 in use. Similar to FIGS. 26 and 35A, the polishing element 600 can be suppressed to a smaller maximum diameter when an external force is applied, for example, to the bipartite bead 405. As shown in FIG. 44, the slotted tube 509 may be compressed in the sheath 801 thereby reducing the radial width of the slotted tube 509. As described above, the polishing element 600 can return to its non-suppressed form when removed from the sheath 801 as shown in FIG. 43. 27, 30 and 36A, similar to the embodiments described above, the polishing element 600 can expand in diameter when rotated at high speeds and when rotation is stopped. It is possible to return to the non-suppressed form.

[0127] FIGS. 49-52 show a polishing element 700 according to another embodiment similar to the polishing element 400 (eg, as shown in FIG. 11), except that the bipartite bead 705 has a different shape. The bipartite rim 705 is shown as not extending over slot 416 of the slotted tube 409, but in some embodiments the bipartite rim 705 extends at least partially or completely over the slot.

[0128] FIGS. 53-56 show the polishing element 1000 according to another embodiment similar to the polishing element 700, except that the bead edges 705 are longitudinally offset from each other. Therefore, as described above, the polishing range of the polishing element 1000 extends beyond a small trajectory when the polishing element 1000 is rotated by the drive shaft 5.

[0129] The atherectomy system disclosed herein can be used, for example, in the following embodiments. A guide wire is inserted into the patient and can move forward on the area of interest. A rotatable drive shaft with the abrasive element attached to its proximal portion can be advanced on the guide wire. The rotatable drive shaft and polishing element can be advanced through the sheath. In some embodiments, the abrasive element expands radially as it advances and exits the sheath. In some embodiments, the polishing element expands to a first diameter when rotated at a first speed and from a first diameter when rotated at a second speed greater than the first speed. Extend to a larger second diameter. Abrasive elements can be advanced on arterial lesions. The abrasive element can be rotated to remove the arterial lesion. The fluid may or may not be carried through the sheath. Arterial lesions may be resected and abrasive elements, drive shafts, sheaths and guide wires may be removed from the patient. In some embodiments, it is sucked and the material is pulled out through the drive shaft.

[0130] One of ordinary skill in the art is one of the features described herein that the disclosed embodiments and features are not limited to any particular embodiment of the atherectomy system. Or you will recognize that a atherectomy system with multiple can be designed for use in a variety of medical procedures. Moreover, one of ordinary skill in the art will recognize the interchangeability of various features from different embodiments. For example, the features of the polishing elements disclosed in various embodiments can be interchanged between embodiments. In addition to the variants described herein, other known equivalents of each feature have been mixed and combined by one of ordinary skill in the art for polishing elements and atherectomy according to the principles of the invention. You can build a technique.

[0131] It should be understood that, of course, not all objectives or benefits need to be achieved by any particular embodiment of the invention. Thus, for example, the present invention achieves or optimizes one advantage or group of advantages as taught herein and achieves another purpose or advantage as can necessarily be taught or proposed herein. Those skilled in the art will recognize that they can be embodied or implemented in ways that do not need to be done.

[0132] Further, while the invention has been disclosed in the context of specific embodiments and examples, the invention goes beyond the details disclosed embodiments to other alternative embodiments and / or the invention. It will be appreciated by those skilled in the art that it extends to its use and its well-defined variants and equivalents. Accordingly, it is intended that the scope of the invention disclosed herein should not be limited by the particular disclosed embodiments described above.

1 ... Rotary atherectomy system 3 ... Drive system 5 ... Drive shaft 30,200,300,400,500,600,700,1000 ... Polishing element 201,405,505,705 ... Ball edge 203,433 ... Tube Cavity 205… Inclined end 207,407… External surface 211,311,411… Distal end 213,313,413… Proximal end 221… Distal notch 223… Proximal notch 301… Distal mass center 303 ... Proximal mass center 409,509 ... Slotted tube 416 ... Slot 440 ... Lower surface 445 ... Transition part 450 ... Central polishing area 455 ... Mounting area 460 ... Pipe gap area 515 ... Void 516 ... Opening 520 ... Support rod 800 ... Welded part 801 ... Sheath 900 ... Blood vessel 910, 920 ... Orbit

Claims (8)

A device for atherectomy,
With a flexible, elongated rotatable drive shaft,
A polishing element having a substantially cylindrical shape arranged on the drive shaft,
Equipped with
The polishing element has a first end having a first radial center of mass, the first center of mass being offset in the first radial direction.
The polishing element has a second end having a second mass center radially offset, proximal to the first mass center and opposite to the first mass center.
The second center of mass is located proximal to the first center of mass and is offset in the second radial direction.
The second radial direction is primarily the opposite of the first radial direction, the atherectomy device. The atherectomy device according to claim 1.
The polishing element is a atherectomy device comprising a lumbar region disposed between the first end and the second end. The atherectomy device according to claim 1 or 2.
The polishing element is an atherectomy device having an eccentric shape. The atherectomy device according to any one of claims 1 to 3.
An atherectomy device configured such that the drive shaft is advanced on a guide wire and rotated around the guide wire. The atherectomy device according to any one of claims 1 to 4, wherein the polishing element includes an outer surface rough as compared with the outer surface of the drive shaft. The atherectomy device according to any one of claims 1 to 5 .
An atherectomy in which the abrasive element has a distal end and a proximal end and is configured as a substantially cylindrical structure at a position between the distal end and the proximal end. Surgical device. The atherectomy device according to any one of claims 1 to 6 .
The polishing element is a device for atherectomy containing tungsten. The atherectomy device according to any one of claims 1 to 7 .
An atherectomy device in which the first end and the second end of the polishing element are made of a heavier material than the rest of the polishing element.

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