JP2017536944A - Apparatus, system and method for pilot tip bushing for rotary atherectomy - Google Patents

Abstract

A high speed rotary atherectomy device for opening an opening in a stenosis in a artery having a predetermined diameter is a flexible wire having a guide wire, a proximal end and a distal end and advanceable on the guide wire. An elongate rotatable drive shaft and a pilot element fixedly attached to the drive shaft. When the pilot element is advanced to the constriction, the pilot hole is formed by rotation of the drive shaft.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application claims priority to US Provisional Patent Application No. 61 / 780,283, filed on March 14, 2013, and is filed on January 28, 2014. No. 14/166207, a continuation-in-part of U.S. patent application Ser. No. 14 / 535,915, filed Nov. 7, 2014, which is hereby incorporated by reference in its entirety. Embedded in.

FIELD OF THE INVENTION The present invention relates to an apparatus and method for ablating tissue from a body flow path, for example, ablating atherosclerotic plaque from an artery using a high speed rotating atherectomy ablation device.

Description of Related Art Various techniques and devices have been developed that are used to ablate or repair tissue in arteries and similar body channels. The primary purpose of these techniques and devices is to remove atherosclerotic plaque in the patient's arteries. Atherosclerosis is characterized by the accumulation of fat deposits (atheromas) in the lining of the patient's blood vessels (under the vascular endothelium). Very often, the first relatively soft and deposited cholesterol-rich atherosclerotic substance hardens over time into calcified atherosclerotic plaques. Because such atheroma inhibits blood flow, it is often referred to as a stenotic lesion or stenosis, and the blocking substance is referred to as a stenotic substance. If left untreated, such stenosis can cause angina, hypertension, myocardial infarction, and stroke.

  Rotational atherectomy resection procedures have become a common technique for resecting such stenotic material. Most often, such a procedure is used to open an opening in a calcified lesion in the coronary artery. In most cases, a rotational atherectomy resection procedure is not used alone, and a balloon angioplasty is often performed after this procedure, followed by placement of a stent to maintain the patency of the opened artery. For non-calcified lesions, most often stents are placed to open the artery using balloon angioplasty alone and maintain the patency of the opened artery. However, patients who have undergone balloon angioplasty and have placed a stent in their arteries often have frequent stent restenosis, i.e., over time, due to overgrowth of scar tissue within the stent. Studies have shown that they experience stent blockages that form in In this case, atherectomy is the preferred method for excising excess scar tissue from the stent (balloon angioplasty is less effective within the stent) and restores the patency of the artery.

  Several types of rotary atherectomy ablation devices have been developed to ablate stenotic material. For example, in a device of the type shown in US Pat. No. 4,990,134 (Auth), a burl covered with an abrasive material such as diamond particles is attached to the distal end of a flexible transmission shaft. The bar rotates at high speed (typically at about 150000-190000 rpm) as it is advanced through the stenosis. However, the bar blocks blood flow when resecting stenotic tissue. When the bar is advanced and penetrates the stenosis, the artery is opened to a diameter that is equal to or slightly larger than the maximum outer diameter of the bar. Often more than one bar must be used to open the artery to the desired diameter.

  US Pat. No. 5,314,438 (Shturman) discloses another atherectomy device. The atherectomy device includes a drive shaft, a portion of the drive shaft having an enlarged diameter, and at least a portion of the enlarged surface is covered with an abrasive to define an abrasive segment of the drive shaft. When rotated at high speed, the abrasive segment can ablate stenotic tissue from the artery. This atherectomy device has certain advantages over the Auth device because of its flexibility, but because it is not eccentric, it opens the artery only to a diameter approximately equal to the diameter of the enlarged polished surface of the drive shaft. I can't.

  US Pat. No. 6,494,890 (Shturman) discloses a known atherectomy device. The atherectomy device includes a drive shaft having an enlarged eccentric portion, and at least one segment of the enlarged eccentric portion is covered with an abrasive. When rotated at high speed, the abrasive segment can ablate stenotic tissue from the artery. This device can open the artery to a diameter larger than the stationary diameter of the enlarged eccentric part by the orbital rotational motion during high-speed operation partially. Because the enlarged eccentric portion comprises a drive shaft wire that is not constrained integrally, the enlarged eccentric portion of the drive shaft can be deflected when placed in a constriction or during high speed operation. This deflection allows opening of a larger diameter during high speed operation, but less control over the diameter of the artery that is actually polished. In addition, a portion of the stenotic tissue may completely block the flow path, making it impossible to place the Shturman device in the flow path. Shturman is almost ineffective when the enlarged eccentric cannot pass through the stenosis because the enlarged eccentric of the drive shaft needs to be placed in the stenotic tissue to achieve polishing. The entire disclosure of US Pat. No. 6,494,890 is incorporated herein by reference.

  US Pat. No. 5,681,336 (Clement) provides a known eccentric tissue resection bar. The outer surface portion of the bar has a coating of abrasive particles adhered by a suitable adhesive. However, this configuration, as Clement explained in column 3, lines 53-55, the asymmetric bar is "rotated at a lower speed than is used in high speed ablation devices to compensate for heat or imbalance" Therefore, it is limited. That is, due to both the size and mass of the solid bar, it is not possible to rotate the bar at the high speeds used during atherectomy, i.e., 20000-200000 rpm. In essence, the center of mass deviated from the axis of rotation of the drive shaft creates a large centrifugal force, which exerts excessive pressure on the arterial wall, generating excessive heat and excessively large particles.

  In some situations, if the atherectomy device is pushed into the lesion at a high rotational speed, the device can be screwed into the lesion. Furthermore, due to the diameter of the bar, the atherectomy device can be limited to the treatment of certain size lesions or stenosis. For these and other reasons, preferably the atherectomy ablation device includes an abrasive structure disposed distally from the ablation bar, the abrasive structure piloting the stenosis first before the polishing head contacts the stenosis. Create a hole. Prior art, such as US Pat. No. 6,482,216 (Hiblar), proposes a device having a concentric cutting bar mounted on a drive shaft and a concentric abrasive tip mounted on the end of a guide wire. When the abrasive tip contacts the deposit, the device excises the deposit from the vessel or stent without fitting into the deposit. However, the pathways and diameters that can be treated by such devices are limited to minimally sized lesions.

  The present invention overcomes these shortcomings and provides improvements over those specifically described above.

SUMMARY OF THE INVENTION The system relates to various methods, apparatus and systems related to rotational atherectomy ablation. More specifically, a pilot element is attached to the drive shaft, and the pilot element includes a shape and structure that facilitates opening a pilot hole through a difficult occlusion and / or stenosis.

  In some embodiments, a high speed rotating atherectomy device for opening an opening in a stenosis in a artery having a predetermined diameter is advanced over the guide wire with a guide wire having a maximum diameter smaller than the diameter of the artery. And a possible elongate flexible drive shaft, the drive shaft having a proximal end and a distal end and comprising a pilot element fixedly mounted near the distal end of the drive shaft. In some embodiments, the pilot element has a concentric or eccentric shape.

  In at least one embodiment, the pilot element includes a proximal portion that extends distally from the proximal end of the pilot element, a distal portion that extends proximally from the distal end of the pilot element, and An intermediate portion extending between the proximal portion and the distal portion. The proximal portion has a constant diameter. The diameter of the distal end of the pilot element is smaller than the diameter of the proximal end of the pilot element. The diameter of the distal portion of the pilot element increases proximally from the distal end of the pilot element. The intermediate portion of the pilot element has a generally parabolic shape, and the diameter of the intermediate portion of the pilot element increases from the proximal portion of the pilot element to the maximum diameter distally and then distally the distal portion of the pilot element Decrease to. The pilot elements may be concentric or eccentric. In some embodiments, the pilot element has a lumen having a diameter greater than the diameter of the drive shaft, at least in the proximal portion. In at least one embodiment, the pilot element has a diameter that is smaller than the diameter of the drive shaft.

  A method is provided for opening an opening in a stenosis in a blood vessel having a predetermined diameter. The method includes providing a guide wire having a maximum diameter that is smaller than the diameter of the artery, advancing the guide wire within the blood vessel to a position proximate to the stenosis, and an elongate flexibility that can be advanced over the guide wire. Providing a rotary drive shaft. The drive shaft has a maximum diameter that is smaller than the diameter of the artery. The drive shaft has a rotation axis. The drive shaft has a pilot element fixedly attached to the drive shaft. The method comprises advancing a pilot element within the artery to a position proximate to the stenosis and forming a pilot hole by rotating the drive shaft at a sufficient rotational speed. In some embodiments, since the pilot element has an orbital path, the pilot hole has a diameter that is greater than the maximum diameter of the pilot element.

1 is a perspective view illustrating a non-limiting exemplary embodiment of a rotary atherectomy device. FIG. FIG. 6 is a perspective view illustrating a non-limiting exemplary embodiment of a pilot element for a rotary atherectomy device. FIG. 3 is a side view showing the pilot element of FIG. 2. FIG. 4 is an end view showing the pilot element of FIGS. 2 and 3 from the distal end. FIG. 5 is an end view of the pilot element of FIGS. 2-4 from the proximal end. FIG. 7 is a perspective view of another non-limiting exemplary embodiment of a pilot element for a rotary atherectomy device. FIG. 7 is a side view showing the pilot element of FIG. 6. FIG. 8 is an end view of the pilot element of FIGS. 6-7 from the distal end. FIG. 9 is an end view of the pilot element of FIGS. 6-8 from the proximal end. FIG. 10 is a perspective view of another non-limiting exemplary embodiment of a rotary atherectomy device. FIG. 8 is a perspective view of yet another non-limiting exemplary embodiment of a rotary atherectomy device. 1 is a perspective view illustrating a non-limiting exemplary embodiment of a rotary atherectomy device. FIG. FIG. 13 is a perspective view showing the pilot element of FIG. 2 used in the rotary atherectomy device of FIGS. 11 and 12. FIG. 14 is a side view showing the pilot element of FIG. 13. FIG. 12 is a perspective view showing the pilot element of FIG. 6 used in the rotary atherectomy device of FIG. 11. FIG. 16 is a side view showing the pilot element of FIG. 15. FIG. 12 is a perspective view of the pilot element of FIG. 2 used in the rotary atherectomy device of FIG. 11 with a flexible drive shaft inserted into at least a portion of the pilot element. FIG. 18 is a side view showing the pilot element of FIG. 17. FIG. 13 is a perspective view of the pilot element of FIG. 6 used in the rotary atherectomy device of FIGS. 11 and 12 with a flexible drive shaft inserted into at least a portion of the pilot element. FIG. 20 is a side view showing the pilot element of FIG. 19.

DETAILED DESCRIPTION While the details of the present invention are shown by way of example in the drawings and are described in detail herein, the present invention can be modified in various modifications and alternatives. It should be understood, however, that the invention is not limited to the specific embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

  Various embodiments of the present invention include a rotational atherectomy system generally described in US Pat. No. 6,494,890, incorporated herein by reference and entitled “Eccentric Rotational Atherectomy Device”. . Further, the disclosures of the following co-owned patents or patent applications are hereby incorporated by reference in their entirety. These co-owned patents or patent applications are listed in US Pat. No. 6,295,712 entitled “Rotary Atherectomy Device”, US Pat. No. 6,132,444 entitled “Eccentric Drive Shaft and Manufacturing Method for Atherectomy Device”. US Pat. No. 6,638,288 entitled “Eccentric drive shaft and method of manufacture for atherectomy device”, US Pat. No. 5,314,438 entitled “Abrasive drive device for atherectomy device”, “Rotary atherectomy” US Pat. No. 6,217,595 entitled “Apparatus”; US Pat. No. 5,554,163 entitled “Atherectomy Device”; US Pat. No. 7,507,245 entitled “Rotary Angioplasty Device With Abrasive Crown”; Rotational atherectomy excision with a radially expandable prime mover connection US Pat. No. 6,129,734 entitled “Eccentric Abrasive Head for High Speed Rotational Atherectomy Device”, US Pat. No. 8,597,313, “System, Apparatus and Method for Opening an Occluded Lesion” U.S. Patent No. 8439937 entitled "Eccentric Abrasive Element for High Speed Rotational Atherectomy Device", US Patent Application No. 2009/0299392, "A laterally offset center of mass for an atherectomy device" US patent application 2010/0198239 entitled "Multi-material polishing head having", US patent application 2010/0036402 entitled "Rotary atherectomy device with pre-curved drive shaft", "High-speed rotation" US patent application entitled "Eccentric grinding and cutting head for atherectomy device" US 09/0299391, US Patent Application No. 2010/0100110 entitled “Eccentric Grinding and Cutting Head for High Speed Rotational Atherectomy Cutting Device”, US Utility Model Patent entitled “Abrasive Crown of Rotating Atherectomy Cutting Device” No. D610258, US utility model patent D6101072, entitled “Abrasive crown of rotary atherectomy device”, US patent application 2009 entitled “Bidirectionally expandable head for rotary atherectomy device” US Pat. No. 2010/0211088 entitled “Segmented Polishing Head and Method for Improving Polishing Efficiency of a Rotary Atherectomy Device” and “Rotary Atherectomy Device with Electric Motor” U.S. Patent Application No. 2013 entitled / 0018398 is included.

  In addition to or in lieu of the above, co-owned US Pat. No. 8,348,965, which is incorporated herein by reference in its entirety and entitled “Rotary Atherectomy Device with Counterweight,” Non-limiting exemplary embodiments of the device are disclosed. The disclosed rotary atherectomy ablation device has a flexible elongated rotatable drive shaft that includes an abrasive portion having an enlarged portion of the drive shaft or a solid abrasive crown that can be attached to the drive shaft. The apparatus further includes a proximal counterweight and / or a distal counterweight attached to the drive shaft and spaced from the polishing portion, each counterweight having a center of mass offset from the longitudinal axis of the drive shaft and polishing Induces orbital motion by the part. When placed in an artery with respect to a stenotic tissue and rotated at a sufficiently high speed (for example, within a range of about 20,000 rpm to about 200,000 rpm), the polishing section is moved more than the stationary diameter of the polishing section by the orbital movement of the polishing section. Also rotate to open an opening having a substantially larger diameter in the stenotic lesion.

  In addition to the above, co-owned US Pat. Nos. 8,551,128 and 8,628,551, which are incorporated herein by reference in their entirety and entitled “Rotary atherectomy device with pre-bent drive shaft,” Discloses a rotary atherectomy ablation system, apparatus and method comprising a flexible elongated rotatable drive shaft. The drive shaft has a polishing portion located in a pre-bent portion of the drive shaft. The apparatus may further include a concentric or eccentric diameter-enlarged portion that is at least partially covered with an abrasive that forms the polishing portion. The polishing portion may further include a polishing crown or a polishing bar attached to the drive shaft. With a pre-bent drive shaft, smaller diameters and / or larger polishing areas can be used, and larger diameters can be swept during high speed rotation. The pre-bent region is stretched substantially straight for insertion into the vasculature and is placed adjacent to the stenosis by inserting a guide wire. By removing the guide wire along the proximal direction from the pre-bent region, the drive shaft can be returned to a curvilinear shape for cutting. When the guidewire is reinserted beyond the pre-bent area, the drive shaft becomes straight and is easily removed.

  One or more features, including the configuration, arrangement, position, operational characteristics and functional characteristics, etc. of various non-limiting exemplary embodiments of any and all polishing elements are equivalent or substantially equivalent to the pilot elements of the present disclosure. Can be applied equally. One or more pilot elements may be provided alone and / or in combination with one or more abrasive elements.

  FIG. 1 shows an embodiment of a rotary atherectomy device according to the present invention. The apparatus includes a handle 10, an elongate flexible drive shaft 20, and an elongate catheter 13 extending distally from the handle 10. The drive shaft 20 includes an eccentric abrasive element 28 and a pilot element 29 that includes a pilot tip or bushing attached or otherwise disposed on the flexible drive shaft at a distal point of the abrasive element 28. Prepare. The drive shaft 20 is comprised of a wire wound around a helical coil as is well known in the art, and the abrasive element 28 and pilot element 29 are fixedly attached to the drive shaft 20. The drive shaft 20 has an outer surface 24 and an inner surface 22 that defines a lumen. This allows the drive shaft 20 to advance and rotate on the guidewire 15. Catheter 13 has a lumen for receiving most of the drive shaft 20 except for the enlarged abrasive element 28 and the portion of the drive shaft 20 distal to the enlarged abrasive element 28. A fluid supply line 17 may be provided to introduce a cooling solution and a lubricating solution (generally saline or another biocompatible fluid) into the catheter 13.

  FIG. 10 illustrates another non-limiting exemplary embodiment of a rotary atherectomy ablation device that does not include an abrasive element 28. The apparatus shown in FIG. 10 is substantially similar to the apparatus described with reference to FIG. 1 in all other respects.

  Desirably, the handle 10 includes a turbine (or similar rotational drive mechanism) for rotating the drive shaft 20 at high speed. In general, the handle 10 may be connected to a power source such as compressed air supplied through the tube 16. A pair of fiber optic cables or a single fiber optic cable 25 may also be provided to monitor the rotational speed of the turbine and drive shaft 20 (details regarding handles and associated instruments are well known in the art). For example, as described in US Pat. No. 5,314,407 issued to Auth). Also preferably, the handle 10 includes a control knob 11 for advancing and retracting the turbine and drive shaft 20 relative to the catheter 13 and the body of the handle.

  As described above, in at least one embodiment, the eccentric abrasive element 28 comprises an eccentric enlargement of the drive shaft, or an eccentric solid crown, or an eccentric bar attached to the drive shaft. In some embodiments, the polishing element 28 has a center of mass that is radially spaced from the rotational axis of the drive shaft 20. This can facilitate the ability of the device to open an opening having a diameter substantially larger than the outer diameter of the polishing element 28 in the stenotic lesion. This means that the geometric center of the polishing element 28, i.e. the eccentric enlarged portion of the drive shaft 20, or an eccentric solid polishing element, e.g. a polishing head or polishing crown or bar attached to the drive shaft 20, It can be achieved by separating from the 20 rotation axes. Alternatively, by providing an abrasive element 28 comprising different combinations of materials, specifically including at least one side of the abrasive element 28 with a heavier or denser material than the other side, By forming the eccentricity described in the book, the center of mass of the polishing element 28 can be spaced radially from the rotational axis of the drive shaft. As those skilled in the art will recognize, the formation of eccentricity by the use of different materials within the structure of the polishing element 28, eg, the formation of a center of mass that is offset from the rotational axis of the drive shaft, can be concentric solid bar or eccentric solid bar. Regardless of whether it is a generally hollow crown or abrasive element, or an enlarged portion of the drive shaft, or equivalent, it is applicable to any embodiment of the abrasive element 28 described herein. When the drive shaft 20 rotates at a high rotational speed, it facilitates the orbital motion of the eccentric abrasive element 28 and forms an ablation diameter that is larger than the diameter of the abrasive element.

  In the present invention, the polishing element 28 can include a concentric shape or an eccentric shape. In some embodiments, by using different density materials and / or by moving the center of mass of the polishing element 28 geometrically along the radial direction from the center of mass of the drive shaft, By placing the center of mass at a position that is radially offset from the rotational axis of the drive shaft, the polishing element 28 can achieve orbital motion. This “eccentricity” can be achieved with either a concentric geometry or an eccentric geometry. The polishing element 28 may be an enlarged portion of the drive shaft, a bar, or a curved polishing element, and may include a diamond coating. In other embodiments, the polishing element 28 can include a center of mass located on the rotational axis of the drive shaft.

  However, the known abrasive elements 28 described above are limited to the smallest size lesions that can be treated because the abrasive features of the abrasive elements have a diameter that is greater than the diameter of the drive shaft. The device solves this problem among others. In addition, when pushing or driving a known abrasive element into a lesion, the abrasive element 28 may grip and distort the lesion by subsequent formation and release of force, thus causing undesirable effects on the lesion or blood vessel. There is a possibility of effect. The present invention solves this problem by opening a pilot hole having a diameter equal to the diameter of the flexible drive shaft of the atherectomy ablation system. This creates a minimum necessary clearance between the polishing element 28 and the lesion, preventing the lesion from being grasped and twisted.

  The pilot element 29 may be fixedly attached to the drive shaft 20 by being attached directly to the outer surface of the drive shaft or by being attached to the drive shaft along the axial direction at the distal end of the drive shaft. . Since the pilot element 29 is fixedly attached to the drive shaft 20 with the polishing element 28, it rotates in the same direction and at the same speed as the polishing element 28.

  The pilot element 29 may be coupled to the drive shaft 20 with a concentric or eccentric shaped polishing element 28 as described with reference to FIG. In alternative embodiments, the pilot element 29 may be coupled to the drive shaft 20 without a concentric or eccentric shaped polishing element 28. The pilot element 29 may be coupled to a concentric or eccentric shaped polishing element 28. In this case, the center of gravity of the polishing element is offset in the radial direction from the center of mass of the drive shaft. The pilot element 29 may be coupled to a concentric or eccentric shaped polishing element 28. In this case, the center of mass of the polishing element is collinear with the center of mass of the drive shaft. The pilot element 29 coupled to the drive shaft 20 with or without the polishing element 28 may have a concentric shape or an eccentric shape. Regardless of the presence or absence of the polishing element 28, the pilot element can be removed from the drive shaft rotation axis using a center of mass that is collinear with the drive shaft rotation axis, or a technique similar to the connection of the polishing element 28 described above. It is also possible to provide a center of mass that is offset in the radial direction. Therefore, when the polishing element 28 is not provided, the pilot element 29 configured as described above has the same operating characteristics and functional characteristics as the polishing element 28 described. In at least one embodiment, the polishing element 28 is eccentric, the pilot element 29 is concentric, and the polishing element 28 functions as a counterweight and causes the orbital motion of the pilot element 29, thereby polishing element 28. Increase the diameter of rotation. In some embodiments, both the polishing element 28 and the pilot element 29 are eccentric. In yet other embodiments, both the polishing element 28 and the pilot element 29 are concentric. In a non-limiting exemplary embodiment that does not have the polishing element 28, the eccentricity and / or position of the center of mass of the pilot element 29 can increase the diameter of the rotational motion.

  The pilot element 29 may be spaced apart from the polishing element 28 along the drive shaft 20. In other embodiments, the proximal end of pilot element 29 abuts the distal end of polishing element 28. In at least some embodiments, the pilot element 29 includes a tip having a diameter similar to the drive shaft to facilitate opening an opening in the stenosis in preparation for rotational entry of the polishing element.

  2-9 show non-limiting exemplary shapes of the pilot element 29. In certain embodiments, pilot element 29 comprises a proximal end 42, a distal end 44, an outer surface 46, and an inner surface 48 that defines a lumen. In some embodiments where the pilot element 29 is fixedly installed around the outer surface of the drive shaft 20, the inner surface 48 of the pilot element 29 fits or engages the outer surface 24 of the drive shaft 20. In another embodiment, the pilot element 29 is fixedly attached to the distal end of the drive shaft 20 such that the lumen defined by the inner surface 48 causes the pilot element 29 to advance and rotate over the guidewire 15. Can do. Significantly, the pilot element 29 is fixedly mounted on the outer surface of the drive shaft or fixedly attached to the distal end of the drive shaft 20. This causes the pilot element 29 to rotate with the polishing element, rather than rotating separately or selectively.

  The pilot element 29 may have a shape with a distal end having a smaller diameter than the proximal end. In some embodiments, the diameter of the pilot element 29 increases from the distal end 44 to the proximal end 42. In some embodiments, the pilot element 29 has a spherical shape. In some embodiments, for example in the embodiment shown in FIGS. 2 and 3, the outer diameter of the pilot element 29 has a constant diameter at the proximal portion that extends distally of the proximal end 42. In the middle part, the diameter of the pilot element 29 increases to a maximum at the distal end of the middle part. At the distal portion, the diameter of the pilot element 29 decreases with a constant slope and decreases at the distal end 44 to a diameter smaller than the constant diameter of the proximal end. In some embodiments, for example, in the embodiment shown in FIGS. 6 and 7, the outer diameter of the pilot element 29 has a constant diameter at the proximal portion that extends distally of the proximal end 42. In the middle part, the diameter of the pilot element 29 increases to a maximum at the distal end of the middle part. At the distal portion, the outer diameter of the pilot element 29 decreases at the distal end 44 to a diameter that is smaller than the constant diameter of the proximal end. In some embodiments, the outer diameter of the pilot element 29 may be reduced to a diameter that is smaller than the outer diameter of the drive shaft. In the embodiment shown in FIGS. 2-9, the pilot element 29 is symmetrical about the central axis. In other embodiments, the pilot element 29 is asymmetric with respect to the central axis. Thereby, the pilot element 29 has an orbital path. This orbital path may be different from or similar to the orbital path of the polishing element 28.

  The pilot element 29 may have an abrasive coating disposed on part or all of the outer surface 46 of the pilot element 29. The abrasive coating may be placed in a separate area in the desired pattern. In some embodiments, the pilot element 29 has cutting features provided on the outer surface 46. In some embodiments, the pilot element 29 has an impact feature provided on the outer surface 46. In some embodiments, the pilot element 29 has a thread-like cutting feature provided on the outer surface 46. In some embodiments, the pilot element 29 is formed in the shape of an auger drill bit with a helical screw blade.

  In some embodiments, the pilot element 29 can be used to form a pilot cavity that penetrates the stenosis or extends distally from the pilot hole into the stenosis, as will be readily apparent to those skilled in the art. An existing cavity can be formed. For example, in a non-limiting exemplary embodiment, after opening the pilot hole, the cavity can be achieved by continuing advancement of the pilot element 29 to penetrate the stenosis distally. Thus, a pilot cavity can be formed using the atherectomy device with or without the polishing element 28. For devices with an abrasive element 28 proximal to the pilot element 29, the pilot cavity can be formed by separating the abrasive element 28 and the pilot element 29 by a distance approximately equal to the length of the stenosis. As described elsewhere, in a non-limiting exemplary embodiment, by using a pilot tip or bushing having a center of mass radially offset from the axis of rotation, or causing an eccentric rotation path Thus, the diameter of the pilot cavity is made larger than the maximum outer diameter of the pilot element 29 by using an eccentric pilot element 29 with a mass element fixed at the proximal and / or distal end of the pilot element 29 Can do. In a non-limiting exemplary embodiment, as described elsewhere, the polishing element 28 can be used to form a pilot cavity having a diameter that is greater than the maximum outer diameter of the pilot element 29. Additional embodiments for configuring and / or using a pilot element 29 to form a pilot hole and / or a pilot cavity through the stenosis as described herein will be apparent to those skilled in the art. It will be. All such embodiments are considered to fall within the scope of the claimed disclosure.

  A method for opening an opening in a stenosis in a blood vessel having a predetermined diameter includes providing a guide wire having a maximum diameter smaller than the diameter of the artery and advancing the guide wire to a position proximate to the stenosis in the blood vessel. And providing an elongate flexible rotatable drive shaft advanceable on the guide wire. The drive shaft has a maximum diameter that is smaller than the diameter of the artery. The drive shaft has a rotation axis. The drive shaft has at least one eccentric abrasive element 28 and pilot element 29 fixedly attached to the drive shaft. The method includes advancing the pilot element 29 within the artery to a position proximate to the stenosis, forming the pilot hole by rotating the drive shaft at a sufficient rotational speed, and advancing the polishing element 28 through the pilot hole. And moving the drive shaft through the stenotic lesion while rotating the drive shaft at a rotational speed to open an opening having a diameter larger than the nominal diameter of the eccentric enlarged portion in the stenotic lesion.

  FIGS. 11 and 12 illustrate non-limiting exemplary embodiments of rotary atherectomy devices 100 and 150 with a guidewire 15 retracted, respectively. Devices 100 and 150, substantially similar to the non-limiting exemplary rotary atherectomy device described elsewhere with reference to FIGS. 1 and 10. The only difference between the devices 100 and 150 and the devices of FIGS. 1 and 10 is the drive shaft. While the drive shaft 20 of the device of FIGS. 1 and 10 is substantially linear throughout its length, the drive shafts 102 and 152 of the devices 100 and 150 are each a pre-curved or pre-curved distal portion. 104. As shown in FIGS. 11 and 12, the pilot element 29 is fixedly attached to the pre-bent distal portion 104 in a manner similar to that described elsewhere with reference to FIGS. As shown in FIG. 11, the device 100 is substantially linear with the drive shaft 102 located proximal to the pre-bent distal portion 104, as described elsewhere with reference to FIGS. A polishing element 28 fixedly attached to the profile. In contrast to device 100, device 150 does not include polishing element 28.

  In a non-limiting exemplary embodiment, the device 100 uses the guide wire 15 to straighten the pre-bent distal portion 104 or to bend the distal portion 104 into a pre-bent shape. Composed. For example, in the exemplary embodiment shown in FIGS. 2, 3, 6 and 7, when the guidewire 15 extends through or extends through the distal portion 104, the distal portion 104 is , Become linear. As shown in FIGS. 13-16, if the guidewire 15 is retracted proximally so that the guidewire 15 does not penetrate the distal portion 104 or extend through the distal portion 104, the distal The positioning part 104 returns to its pre-bent shape. Of course, the pilot element 29 fixedly attached to the distal portion 104 will also be stretched or bent linearly with the distal portion 104.

  In a non-limiting exemplary embodiment, the device 100 may be configured with a distal portion 104 (and a pilot element 29). As shown in FIGS. 13-16, the distal portion 104 has two separate or discrete portions: a substantially straight portion and a maximally curved portion. For example, in the exemplary embodiments shown in FIGS. 2, 3, 6, and 7, the distal portion is provided when the guidewire 15 is inserted through or extends through the distal portion 104. 104 is substantially linear. When the distal end of the guidewire 15 is pulled out of the distal portion 104 along the proximal direction, the guidewire 15 is not inserted through the distal portion 104 or the distal portion 104 is removed as shown in FIGS. When not extending through, the distal portion 104 is fully bent. Distally, when any portion of the guidewire 15 including the distal end is extended into the distal portion 104, the entire distal portion 104 is substantially as shown in FIGS. 2, 3, 6 and 7. It becomes straight. In some embodiments, the guidewire 15 need not extend or pass through the entire distal portion 104 to straighten the distal portion 104.

  In another non-limiting exemplary embodiment, the device 100 may be configured with a distal portion 104. The distal portion 104 has a bent shape that varies continuously with the amount or length of the guidewire 15 within the distal portion 104. For example, in the exemplary embodiment shown in FIGS. 2, 3, 6 and 7, when the guidewire 15 extends through or extends through the entire distal portion 104 The distal portion 104 is substantially straight. When the distal end of the guide wire 15 is pulled out of the distal portion 104 along the proximal direction, at least a portion of the distal portion 104 located distal to the distal end of the guide wire 15 begins to bend, FIG. A fully bent shape is reached when the guidewire 15 is not inserted through or extends through the distal portion 104, as shown at -16. When the distal end of the guidewire 15 extends into the distally bent distal portion 104, it is inserted by the guidewire 15 and proximal to the distal portion 104 proximal to the distal end of the guidewire. Becomes substantially straight and the distal end of the distal portion 104 distal to the distal end of the guidewire 15 is bent. In the exemplary embodiment shown in FIGS. 2, 3, 6 and 7, when the guidewire 15 is inserted through or extends through the entire distal portion 104, the distal The entire positioning portion 104 is substantially linear.

  As described elsewhere and well known to those skilled in the art, the drive shaft 102/152 extends into the lumen of the catheter 13 and is delivered to the stenosis over the guidewire 15. The drive shaft 102/152 is also configured to rotate about a guide wire 15 extending through the drive shaft. Therefore, the rotation axis 110 of the drive shaft 102/152 substantially coincides with the longitudinal axis of the guide wire 15. Referring to FIGS. 13-16 compared to FIGS. 2, 3, 6 and 7, the guidewire 15 is not inserted through or extends through the distal portion 104. When the distal end 112 of the wire 15 is withdrawn from the distal portion 104 along the proximal direction, it can be seen that the distal portion 104 is fully bent into an initially bent shape, as shown in FIGS. . When the guidewire 15 is retracted into the lumen of the substantially straight drive shaft 102/152 proximal to the pre-bent distal portion 104, the rotation axis 110 of the drive shaft 102/152 and the guidewire 15 The longitudinal axes substantially coincide with each other. Thus, despite the fully bent, partially bent or straight shape of the distal portion 104, the rotational axis 110 of the drive shaft 102/152 and the longitudinal axis of the guide wire 15 are substantially It can be seen that they remain consistent. As can be seen, regardless of whether the guidewire 15 or a portion thereof extends through or even extends through the distal portion 104 and the shape of the distal portion 104. The rotation axis 110 of the drive shaft 102/152 and the longitudinal axis of the guide wire 15 remain substantially coincident with each other. Thus, the terms “rotation axis 110 of drive shaft 102/152” and the term “longitudinal axis of guidewire 15” may be used interchangeably, both referenced by 110.

  As shown in FIGS. 13-16, when the distal portion 104 is maximally bent into an initially bent shape, i.e., the guidewire 15 is not inserted through the distal portion 104 or the distal portion 104 is When not extending through, the distance 106 between the longitudinal axis 108 of the distal portion 104 and the rotational axis 110 of the drive shaft 102/152 is maximized at the distal end 44 of the pilot element 29. In other words, the pilot element 29, in particular its distal end 44, is maximally offset or spaced from the axis of rotation 110 of the drive shaft and the longitudinal axis of the guide wire 15 substantially coincident. As described elsewhere and as will be appreciated by those skilled in the art, when the drive shaft 102/152 rotates about the rotation axis 110, the pilot element 29 that is spaced from the rotation axis 110 causes a trajectory path. This orbital path is likewise offset or spaced from the rotational axis 110 of the drive shaft 102/152. In some embodiments having a concentric pilot element 29 with a center of mass and / or geometric center that coincides with the longitudinal axis 108, the diameter of the orbital path, ie the distance between the orbital path and the rotation axis 110, is a distance 106. Or slightly greater than the distance 106. In certain embodiments, depending on the shape of the pilot element 29, this “slightly larger” diameter is approximately the sum of the distance 106 and the maximum distance between the outer surface 46 of the distal portion 104 and the longitudinal axis 108. May be equal. In some embodiments having an eccentric pilot element 29 with a center of mass and / or geometric center that does not coincide with the longitudinal axis 108, the diameter of the orbital path, i.e., the distance between the orbital path and the axis of rotation 110, is It is a function of the eccentricity of the pilot element 29 and / or the position of the center of mass and / or geometric center. In certain embodiments, the diameter of the orbital path is not a constant, but changes as the pilot element pivots or rotates about the rotational axis 110 of the drive shaft 102/152. Accordingly, the diameter of the trajectory path at many circumferential positions around the rotation axis 110 is smaller and / or equal and / or larger than the distance 106.

  In a non-limiting exemplary embodiment, the distance 106 depends on the initial curved shape of the distal portion 104. In another non-limiting exemplary embodiment, the distance 106 can be customized and / or changed prior to using the device 100. For example, the device 100 can be bent into a substantially straight distal portion 104, or a distal portion 104 having an initial pre-bent shape, or an initial pre-bent shape as desired by the user. It may be manufactured and supplied so as to include the section 104. In a non-limiting exemplary embodiment, shape memory material can be used in at least the bent portion or position of the drive shaft 102/152.

  With reference to FIGS. 2, 3, 6, and 7, when the guidewire 15 extends through or extends through the distal portion 104, the distal portion 104 is substantially straight. It can be seen that it coincides with the drive shaft 102/152 located proximal to the distal portion 104. Thereby, the longitudinal axis 108 of the distal portion 104 and the rotational axis 110 of the drive shaft 102/152 substantially coincide and the distance 106 is negligibly small. As described elsewhere, the orbital path of the pilot element 29 and / or the diameter of the orbital path is determined by the eccentricity or concentricity of the pilot element 29, the position of the center of mass and / or geometric center of the pilot element 29, the pilot element 29 and the function of one or more factors for the pilot element 29 including the presence or absence of the polishing element 28. When the drive shaft 102/152 includes the polishing element 28, the pilot element's orbital path and / or diameter of the orbital path is determined by the eccentricity or concentricity of the polishing element 28, the mass center and / or geometric center of the polishing element 28. It is also a function of one or more factors relating to the polishing element 28, including position and shape of the polishing element 28.

  In a non-limiting exemplary embodiment, the fully bent, partially bent or linear shape of the distal portion 104 can be affected by the advancement and retraction of the distal portion 104 in the catheter 13. For example, if the guidewire 15 does not penetrate the distal portion 104 or extend through the distal portion 104 and / or penetrates the distal portion 104 or extends to a portion of the distal portion 104 If the existing guidewire 15 is sufficiently flexible, the catheter 13 is used to retract all or part of the distal portion 104 proximally and into the lumen of the catheter 13 through which the drive shaft 102/152 passes. Thus, the distal portion 104 can be in a fully bent shape, a partially bent shape, or a linear shape. Conversely, withdrawing or extending all or a portion of the distal portion 104 distally from the lumen of the catheter 13 completely completes at least a portion of the pre-bent distal portion 104 drawn from the lumen of the catheter 13. Can be bent or partially. Of course, the combination of the catheter 13 and the guide wire 15 can be used to make the whole and / or part of the pilot element 29 completely and / or partially linear and / or bent. As described, a non-limiting exemplary embodiment of a rotational atherectomy device having a flexible drive shaft 15 extending through a portion of the distal portion 104 or through the entire distal portion 104 is shown in FIG. 17-20. FIGS. 17 and 18 are perspective and side views, respectively, showing the distal portion 104 or pilot element with a flexible drive shaft 15 extending at least in part thereof. FIGS. 19 and 20 are perspective and side views, respectively, showing the distal portion 104 or pilot element through which the flexible drive shaft 15 extends.

  In some embodiments, the catheter 13 may be used to shape (ie, bend, straight, shape) when the guidewire 15 is inserted or passed through the entire distal portion 104 or at least a portion of the distal portion 104. , And / or partially bent shape / partial linear shape). In other words, such an embodiment does not require the guide wire 15 to be fully withdrawn from the distal portion 104 before the distal portion 104 is withdrawn into or withdrawn from the catheter 13. In certain embodiments, the guidewire 15 must be fully withdrawn from the distal portion 104 before the distal portion 104 is withdrawn into or withdrawn from the catheter 13. In other words, the distal portion 104 is used prior to affecting the shape (ie, bent shape, straight shape, and / or partially bent shape / partial straight shape) using the catheter 13. The guide wire 15 has to be completely pulled out from. Thus, in some embodiments, the guidewire 15 can have a high flexibility. In certain embodiments, the guidewire 15 is sufficiently rigid to bend and straighten with the distal portion 104 while having sufficient flexibility to penetrate the vasculature. May be.

  In a non-limiting exemplary embodiment where the distal portion 104 (and the pilot element 29) has a continuously varying bent shape, the distance 106 is such that the guidewire 15 penetrates the distal portion 104 or distally. Increases or decreases by the amount extending through portion 104. For example, the distance 106 increases when the distal end of the guidewire 15 is retracted proximally into the distal portion 104. On the other hand, the distance 106 decreases as the distal end of the guidewire 15 is extended distally through the distal portion 104. As described elsewhere, when no portion of the guidewire 15 is present in the distal portion 104, that is, the distal end of the guidewire 15 is retracted proximally of the distal portion 104. The distance 106 is at a maximum.

  The entire drive shaft 102/152, including the pre-bent distal section 104 with the pilot element 29, is substantially straight when the guidewire 15 extends or is inserted through the entire distal section 104. The rotational axis 110 of the drive shaft 102/152 and the longitudinal axis of the guide wire 15 substantially coincide with each other. Thus, the entire substantially linear drive shaft 102/152 rotates about the longitudinal axis of the guidewire 15, and the pilot element 29 is as described elsewhere with reference to FIGS. Have an orbital path. When part or all of the distal portion 104 is bent, the rotational axis 110 of the drive shaft 102/152 and the longitudinal axis of the guidewire 15 are substantially coincident. The pilot element 29 attached to the bent distal portion 104 is radially offset or spaced from the substantially coincident rotational axis 110 of the drive shaft 102/152 and the longitudinal axis of the guidewire 15. Thus, when drive shaft 102/152 rotates about its axis of rotation 110, ie, the longitudinal axis of guidewire 15, pilot element 29 is radially spaced from axis of rotation 110 of drive shaft 102/152. Alternatively, the diameter of the trajectory path inserted by the pilot element 29 having an offset trajectory path and attached to the bent distal portion 104 is substantially straight, i.e., unbent distal portion 104. Larger than the diameter of the orbital path inserted by the pilot element 29 attached to the. In an exemplary non-limiting embodiment, the diameter of the trajectory path is substantially similar to the distance 106. In another non-limiting exemplary embodiment, the diameter of the orbital path is any number including the distance 106 and the configuration and / or structure of the pilot element 29 (eg, eccentricity, center of mass location, geometric center location). Depends on these parameters. The operational and functional characteristics of the different configurations and / or structures of the pilot element 29 and the effect on the trajectory path will be described elsewhere with reference to FIGS.

  In some non-limiting exemplary embodiments, the polishing element 28 and the pilot element 29 are configured or constructed such that their trajectories are substantially parallel to each other and attached to the drive shaft 20/102/152. It is done. In certain embodiments, the orbital paths are not parallel to each other. In some embodiments, the diameters of the orbital paths of the polishing element 28 and the pilot element 29 are substantially similar. In certain embodiments, the orbital paths of the polishing element 28 and the pilot element 29 have different diameters. In some embodiments, the center of mass and / or geometric center of the polishing element 28 and the center of mass and / or geometric center of the pilot element 29 may or may not be substantially collinear. Or substantially coplanar or non-coplanar. In certain embodiments, the center of mass and / or geometric center of polishing element 28 and the center of mass and / or geometric center of pilot element 29 are offset in angle. For example, the offset angle between the centers may be in the range of 0 ° to 360 °.

  In some non-limiting exemplary embodiments, the rotational atherectomy device includes a proximal counterweight and / or a distal counterweight for one or both of the polishing element 28 and the pilot element 29. One or more counterweights are disclosed in commonly owned US Pat. No. 8,348,965, which is incorporated herein by reference in its entirety. In U.S. Pat. No. 8,348,965, only counterweights for or related to or connected to the polishing element are shown and described, but similar or different counterweights for or related to or connected to the pilot elements are contemplated, Included within the scope and scope of this disclosure. In certain embodiments, the one or more counterweights are included as separate or discrete components or elements separate from each or corresponding abrasive element 28 and / or pilot element 29. Thus, the one or more counterweights may be fixedly attached to the drive shaft proximate or remote from the polishing element 28 and / or the pilot element 29, or may be otherwise installed on the drive shaft. . In some embodiments, one or more counterweights may be integral with each or corresponding polishing element 28 and / or pilot element 29, or otherwise arranged. In certain embodiments, any two or more counterweights may be substantially collinear or non-collinear, or may be substantially coplanar or non-coplanar. Good. In some embodiments, any two or more counterweights may be offset from each other by an angle ranging from 0 ° to 360 °.

  In view of this, it is to be understood that all configurations, operating characteristics and functional characteristics, etc. of an abrasive element with or without one or more counterweights can be applied to a pilot element in a similar or substantially similar manner. It will be readily and clearly apparent to the merchant. Further, the one or more pilot elements may be provided individually by themselves or in combination with one or more abrasive elements. In addition, one or more pilot elements are secured to a pre-bent drive shaft or a linear drive shaft, i.e. the distal portion or distal tip or distal end of the drive shaft that is not bent. Or may be installed in other ways. All such embodiments, including modifications, are considered to be within the scope of this disclosure.

  Co-owned US Pat. Nos. 8,551,128 and 8,628,551, entitled “Rotary atherectomy device with pre-bent drive shaft”, which is incorporated herein by reference in its entirety, are pre-bent. Various techniques for fixedly forming or configuring the distal portion 104 are disclosed. In a non-limiting exemplary embodiment, a unique thermosetting method is used with conventional metals such as stainless steel. Briefly, the method of forming the pre-curved distal portion 104 is to first wind up the drive shaft using a coil winding machine, and then to relax and stabilize the coil dimensions. The entire wound drive shaft is heated at a predetermined temperature for a predetermined time. Next, a mandrel shaped into the desired curved drive shaft shape is inserted into the lumen at the distal end of the straight (and pre-relaxed) drive shaft. Thus, the distal portion of the drive shaft is forced to take the shape of a mandrel. Next, with the mandrel placed at a predetermined position, a local heat treatment is performed at a predetermined temperature and a predetermined time for the curved portion of the drive shaft. After the local heat treatment is complete, the mandrel is removed and the drive shaft retains the curved shape. Thereby, a pre-curved or pre-curved distal portion 104 is formed.

  Other mechanisms and methods for forming the pre-curved distal portion 104 may include using a shape memory alloy material. In some non-limiting exemplary embodiments, a shape memory alloy material that exhibits superelastic properties and increased flexibility, such as Nitinol, is used. Further non-limiting examples of superelastic metal alloys that can be used to form the pre-curved or pre-curved distal portion 104 are described in detail in US Pat. No. 4,665,906. US Pat. No. 4,665,906 describes the composition, properties, chemistry and behavior of certain metal alloys that are superelastic within the temperature range in which the pre-curved distal portion 104 of the drive shaft 102/152 operates. Thus, it is incorporated herein by reference. Any or all of such superelastic metal alloys can be used to form the pre-curved portion 104 of the drive shaft 102/152.

  Prior to being inserted into the vasculature, the drive shaft 102/152 having the pre-curved distal portion 104 is provided in a pre-curved form. The pre-curved distal portion 104 is then generally linear and / or linear by inserting a substantially straight guide wire 15 into the lumen of the drive shaft and through the distal portion 104. Mechanically “deforms” into the configuration and shape of In particular, with a drive shaft 102/152 having a generally linear and / or straight distal portion 104, a guidewire 15 is introduced into the vasculature to target the distal end or tip of the drive shaft 102/152 to the target. After being placed in close proximity, the guidewire 15 can be withdrawn proximally. This allows the precurved distal portion 104 to return to its original curved shape and configuration.

  Any and all of the above combinations of pilot and abrasive elements in a rotary atherectomy ablation system are within the scope of the present invention. It is to be understood that the present invention is not limited to the specific examples described above, but rather encompasses all aspects of the present invention. Various modifications, equivalent processes and numerous structures to which the present invention can be applied will be readily apparent to those of skill in the art to which the present invention is directed upon review of the specification.

Claims (27)

A device,
A guide wire;
An elongate flexible drive shaft advanceable on the guidewire;
The drive shaft is
A pre-bent distal portion extending proximally from a distal end of the drive shaft;
At least a portion of the distal portion not inserted by the guide wire has a curved shape;
At least a portion of the distal portion inserted by the guide wire has a substantially linear shape;
A pilot element fixedly attached to at least a portion of the distal portion;
An abrasive element fixedly attached to the drive shaft located proximal to the distal portion. The pilot elements are concentric or eccentric;
The apparatus of claim 1, wherein the polishing element is concentric or eccentric. The pilot element has a center of mass that is collinear with or coplanar with the longitudinal axis of the distal portion or a center of mass that is radially offset from the longitudinal axis of the distal portion;
The apparatus of claim 1, wherein the polishing element has a center of mass that is collinear with or coplanar with a rotational axis of the drive shaft or a center of mass that is radially offset from the rotational axis of the drive shaft. The pilot element is symmetric or asymmetric about the longitudinal axis of the distal portion;
The apparatus of claim 1, wherein the polishing element is symmetric or asymmetric about an axis of rotation of the drive shaft.   The apparatus of claim 1, wherein at least a portion of the outer surface of the pilot element includes one of an abrasive coating, a cutting feature, an impact feature, and an auger.   The apparatus of claim 1, wherein the pilot element comprises a spherical shape. The pilot element is
A proximal portion extending distally from a proximal end of the pilot element;
A distal portion extending proximally from a distal end of the pilot element;
The apparatus of claim 1, comprising an intermediate portion extending between the proximal portion and the distal portion of the pilot element.   The apparatus of claim 7, wherein the proximal portion of the pilot element has a substantially constant diameter.   8. The apparatus of claim 7, wherein the diameter of the distal portion of the pilot element increases proximally from the distal end of the pilot element.   8. The apparatus of claim 7, wherein the diameter of the distal end of the pilot element is smaller than the diameter of the proximal end of the pilot element or the diameter of the drive shaft. The intermediate portion of the pilot element has a generally parabolic shape;
The diameter of the intermediate portion of the pilot element increases from the proximal portion of the pilot element to a maximum diameter distally and then decreases distally to the distal portion of the pilot element. The device described.   8. The apparatus of claim 7, wherein the diameter of the intermediate portion of the pilot element increases distally from the proximal portion of the pilot element to a maximum diameter of the distal end of the intermediate portion of the pilot element.   The distance between the longitudinal axis of the distal portion and the longitudinal axis of the guide wire is such that the distal end of the guide wire is pulled proximally from the distal end of the drive shaft through the distal portion. The apparatus of claim 1, wherein the apparatus increases with time.   14. The apparatus of claim 13, wherein the distance between the longitudinal axis of the distal portion and the longitudinal axis of the guidewire is maximum when the distal portion is not inserted through the guidewire. .   The distance between the longitudinal axis of the distal portion and the longitudinal axis of the guidewire decreases as the distal end of the guidewire is extended distally through the distal portion. Equipment.   16. The apparatus of claim 15, wherein at least in the portion of the distal portion that is inserted by the guidewire, the rotational axis of the drive shaft and the longitudinal axis of the guidewire substantially coincide with each other.   The apparatus of claim 1, wherein the pilot element comprises an orbital path that is offset from an axis of rotation of the drive shaft when rotated. The abrasive element is
A proximal portion extending distally from a proximal end of the abrasive element;
A distal portion extending proximally from a distal end of the abrasive element;
The apparatus of claim 1, comprising an intermediate portion extending between the proximal portion and the distal portion of the polishing element. The proximal diameter increases distally;
The apparatus of claim 18, wherein the diameter of the distal portion increases proximally.   The apparatus of claim 18, wherein at least a portion of the outer surface of the polishing element includes one of an abrasive coating, a cutting feature, an impact feature, and an auger.   The apparatus of claim 1, wherein the polishing element comprises an orbital path having a diameter greater than a maximum diameter of the polishing element when rotated. The apparatus comprises a catheter having a lumen extending therethrough;
The drive shaft extends through the lumen of the catheter;
The apparatus of claim 1, wherein the shape of the distal portion is affected by the position of the distal portion relative to an opening located at a distal end of the lumen of the catheter. When the entire distal portion is withdrawn from the lumen of the catheter, the shape of the distal portion changes from the substantially linear shape to the curved shape;
23. The device of claim 22, wherein the shape of the distal portion changes from the curvilinear shape to the substantially linear shape when the entire distal portion is retracted into the lumen of the catheter. The shape of at least the portion of the distal portion drawn from the lumen of the catheter changes from the substantially linear shape to a non-linear shape;
24. The apparatus of claim 23, wherein the shape of at least the portion of the distal portion drawn into the lumen of the catheter changes from the non-linear shape to the substantially linear shape. A device,
A guide wire;
An elongate flexible drive shaft advanceable on the guidewire;
The drive shaft is
A pre-bent distal portion extending proximally from a distal end of the drive shaft;
At least a portion of the distal portion not inserted by the guide wire has a curved shape;
At least a portion of the distal portion inserted by the guide wire has a substantially linear shape;
An apparatus comprising a pilot element fixedly attached to at least a portion of the distal portion. A device,
A guide wire;
An elongate flexible drive shaft advanceable on the guidewire;
The drive shaft is
A pre-bent distal portion extending proximally from the distal end of the drive shaft, the distal portion changing shape between a predetermined curvilinear shape and a substantially linear shape Composed of
A pilot element fixedly attached to at least a portion of the distal portion;
An abrasive element fixedly attached to the drive shaft proximal to the distal portion;
The apparatus wherein the guidewire is flexible enough to change shape between a curved shape and a substantially linear shape in response to a change in the shape of the distal portion. A device,
A guide wire;
An elongate flexible drive shaft advanceable on the guidewire;
The drive shaft is
A pre-bent distal portion extending proximally from a distal end of the drive shaft, the distal portion configured to change shape between a curved shape and a substantially linear shape And
A pilot element fixedly attached to at least a portion of the distal portion;
The apparatus wherein the guidewire is flexible enough to change shape between a curved shape and a substantially linear shape in response to a change in the shape of the distal portion.

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