Drive shaft having a metal inner layer and a polymer jacket

Abstract

To provide a device and system comprising a drive shaft for use in high-speed rotational medical procedures; e.g., atherectomy.SOLUTION: A drive shaft 60 is configured for transferring torque and activating rotation of an abrading head to attached thereto, and is covered by a polymer jacket 62. The polymer jacket is allowed to rotate in response to the rotation of the drive shaft such that the polymer jacket is not fixed at its proximal end. The drive shaft may include a proximal stop 70P and a distal stop 70D that enable the polymer jacket to move longitudinally between the stops, or the drive shaft only with the distal stop may include the proximal stop and / or the distal stop that enable the polymer jacket to move longitudinally to the distal stop. The drive shaft may include a metallic inner liner 64 within the drive shaft, in addition to or instead of the polymer jacket.SELECTED DRAWING: Figure 6

Description

[Technical Field]

[0001] Inventor Preston L. Grothe, United States, Minnesota (MN), lives in Maple Grove Matthew D. Cambronne, United States citizen, resident of North Oaks, Minnesota Joseph P. Higgins, United States citizen, Minnesota Minnetonka, MN Jeffrey R. Stone, United States citizen, Minnetonka, Minnesota CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Non-Provisional Patent Application No. 16 / 807,669, filed March 3, 2020, and entitled "Drive Shaft with Metallic Inner Layer and Polymer Jacket," and also claims the benefit of U.S. Provisional Application No. 62 / 834,023, filed April 15, 2019, and entitled "Drive Shaft with Metallic Inner Layer and Polymer Jacket," the entire contents of which are incorporated herein by reference.

[0002] STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not applicable Background of the Invention The technology of the present invention The present disclosure relates to drive shafts used in medical device procedures, and more particularly, to drive shafts used in rotational atherectomy and thrombectomy procedures. [Background technology]

[0003] 2. Description of Related Art A variety of techniques and instruments have been developed for use in the removal or repair of tissue in arteries and similar body passageways. A frequent goal of such techniques and instruments is the removal of atherosclerotic plaque in a patient's arteries. Atherosclerosis is characterized by the buildup of fatty deposits (atheromas) in the intimal layer (below the endothelium) of a patient's blood vessels. Over time, what initially deposits as relatively soft, cholesterol-rich atheromatous material often hardens into calcified atherosclerotic plaques. Because such atheromas restrict blood flow, they are often also called stenotic lesions or stenoses, and the obstructing material is referred to as stenotic material. If left untreated, such stenosis can lead to angina, hypertension, myocardial infarction, stroke, and the like.

[0004] Rotational atherectomy procedures have become a common technique for removing such stenotic material. Such procedures are most frequently used to initiate the opening of calcified lesions in the coronary arteries. In most cases, rotational atherectomy procedures are not used alone, but are frequently followed by a balloon angioplasty procedure, which is then followed by the placement of a stent to help maintain the patency of the opened artery. For non-calcified lesions, balloon angioplasty is often used alone to open the artery, and a stent is often placed to maintain the patency of the opened artery. However, a significant percentage of patients who undergo balloon angioplasty and have a stent placed in their artery do not undergo stent placement. Studies have shown that patients with stent-implanted coronary arteries experience post-stent restenosis. Post-stent restenosis is a blockage of the stent that most often develops over a period of time as a result of excessive scar tissue growth within the stent. In these situations, an atherectomy procedure is the preferred procedure to remove the excess scar tissue from the stent (balloon angioplasty is less effective within a stent), thereby restoring arterial patency. Summary of the Invention [Problem to be solved by the invention]

[0005] Several types of rotational atherectomy devices have been developed in an effort to remove stenotic material. Such devices generally include a drive shaft on which an abrading head is mounted and a handle with a rotatable drive mechanism coupled to a proximal portion of the drive shaft. Known drive shafts used with rotational atherectomy devices generally include metal wire windings, typically of stainless steel construction, and may be covered by a polymer coating or jacket that is longitudinally fixed relative to the drive shaft. The polymer coating or jacket may help contain fluid within and / or around the drive shaft during rotation and, to some extent, help the drive shaft maintain an operating diameter as close as possible to its static diameter during rotation. While the polymer coating may rotate with the drive shaft, the polymer jacket typically does not. In other words, in an atherectomy device that includes a polymer jacket covering the drive shaft, the drive shaft may rotate within the polymer jacket, while the polymer jacket remains stationary relative to the handle. [Means for solving the problem]

[0006] While a polymer jacket longitudinally fixed in place, such as in such known systems, can help a rotating drive shaft maintain a diameter close to its resting diameter during high-speed rotation better than systems that do not include a polymer jacket, Applicant has discovered that such known polymer jackets can be improved. For example, known fixed-position polymer jackets may not sufficiently mitigate other problems that can arise during high-speed rotation of the drive shaft, such as radial deflection of the drive shaft and undesirable vibrations and / or standing waves in the drive shaft during high-speed rotation. Radial deflection of the drive shaft, undesirable vibrations and / or standing waves in the drive shaft during high-speed rotation can deflect the abrading head from its intended path of travel, which in turn can reduce the effectiveness of the abrading head in removing occlusive material and / or contribute to complications caused by uncontrolled contact of the abrading head with the vessel wall.

[0007] Therefore, a rotational medical device (e.g., a rotational atherectomy device) including a drive shaft and a polymer jacket configured to address these challenges is desirable. Such a device may provide improved performance compared to known rotational medical devices, such as by improving the effectiveness of the rotational procedure and reducing the risk of associated complications. Additionally, Applicant has discovered that in some embodiments, a smooth metallic inner layer may be used to provide improved performance of the rotational medical device.

[0008] Various embodiments of the present invention address these challenges, among others. It should be noted that such challenges may arise in devices configured to use rotational procedures other than atherectomy, and that the challenges are similarly addressed by various embodiments of the present invention.

[0009] Additionally, we provide the disclosure of the following patents and applications, each of which belongs to Cardiovascular System, Inc. and is incorporated herein in its entirety: In rare cases, each may include systems, methods and / or devices that can be used in conjunction with various embodiments of the presently disclosed subject matter.

[0010] U.S. Patent No. 9,468,457, "ATHERECTOMY DEVICE WITH ECCENTRIC CROWN"; U.S. Patent No. 9,439,674, "ROTATIONAL ATHERECTOMY DEVICE WITH EXCHANGEABLE DRIVE SHAFT AND MESHING GEARS"; U.S. Patent No. 9,220,529, "ROTATIONAL ATERECTOMY DEVICE WITH ELECTRIC MOTOR"; U.S. Patent No. 9,119,661, "ROTATIONAL ATERECTOMY DEVICE WITH ELECTRIC MOTOR"; U.S. Patent No. 9,119,660, "ROTATIONAL ATERECTOMY DEVICE WITH ELECTRIC MOTOR"; U.S. Patent No. 9,078,692, "Rotational Atherectomy System"; U.S. Patent No. 6,295,712, "ROTATIONAL ATHERECTOMY DEVICE"; U.S. Patent No. 6,494,890, "ECCENTRIC ROTATIONAL ATHERECTOMY DEVICE"; U.S. Patent No. 6,132,444, "ECCENTRIC DRIVE SHAFT FOR ATHERECTOMY DEVICE AND METHOD FOR MANUFACTURE"; U.S. Patent No. 6,638,288, "ECCENTRIC DRIVE SHAFT FOR ATHERECTOMY DEVICE AND METHOD FOR MANUFACTURE"; U.S. Patent No. 5,314,438, "ABRASIVE ROTARY ATHERECTOMY DRIVE SHAFT APPARATUS" DRIVE SHAFT DEVICE FOR ROTATIONAL ATHERECTOMY); U.S. Patent No. 6,217,595, "ROTATIONAL ATHERECTOMY DEVICE"; U.S. Patent No. 5,554,163, "ATHERECTOMY DEVICE"; U.S. Patent No. 7,507,245, "ROTATIONAL ANGIOPLASTY DEVICE WITH ABRASIVE CROWN"; U.S. Patent No. 6,129,734, "ROTATIONAL ATHERECTOMY DEVICE WITH RADIALLY EXPAMDABLE PRIME MOVER COUPLING"; U.S. Patent Application No. 11 / 761,128, "ECCENTRIC ABRADING HEAD FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICE"; U.S. Patent Application No. 11 / 767,725, "SYSTEM, APPARATUS AND METHOD FOR OPENING AN OCCLUDED LESION"; U.S. Patent Application No. 12 / 130,083, "ECCENTRIC ABRADING ELEMENT FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES"; No. 12 / 363,914, entitled "MULTI-MATERIAL ABRADING HEAD FOR ATHERECTOMY DEVICES WITH LATERALLY DISPLACED CENTER OF MASS" ATHERECTOMY DEVICES HAVING LATERALLY DISPLACED CENTER OF MASS)”; U.S. Patent Application No. 12 / 578,222, entitled "Rotational Atherectomy Device with Pre-Curved Drive Shaft" DRIVE SHAFT)"; U.S. Patent Application No. 12 / 130,024, "ECCENTRIC ABRADING AND CUTTING HEAD FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES"; U.S. Patent Application No. 12 / 580,590, "ECCENTRIC ABRADING AND CUTTING HEAD FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES"; U.S. Patent Application No. 29 / 298,320, "ROTAITONAL ATHERECTOMY ABRASIVE CROWN"; U.S. Patent Application No. 29 / 297,122, "ROTAITONAL ATHERECTOMY ABRASIVE CROWN"; U.S. Patent Application No. 12 / 466,130, "BIDIRECTIONAL EXPANDABLE HEAD FOR ROTATIONAL ATHERECTOMY DEVICE" "; U.S. Patent Application No. 12 / 388,703, "ROTATIONAL ATHERECTOMY SEGMENTED ABRADING HEAD AND METHOD FOR IMPROVING ABRADING EFFICIENCY" AND METHOD TO IMPROVE ABRADING EFFICIENCY).

[0011] SUMMARY OF THE INVENTION Various embodiments of rotary devices are disclosed that include a drive shaft for use in high-speed rotational medical procedures, such as atherectomy. Generally, the drive shaft is configured to transmit torque and activate the rotation of a tool attached thereto, such as an abrasive element (also referred to herein as an "abrasive head"), and is covered by a polymer jacket. In certain embodiments, the polymer jacket is loose at its proximal end, allowing it to rotate in response to the rotation of the drive shaft. Various embodiments of the drive shaft may include proximal and / or distal outer stops that allow the polymer jacket to move longitudinally between the stops in embodiments that include proximal and distal outer stops, or to the distal outer stop in embodiments that include only distal stops. Various embodiments of the devices and systems described herein may optionally include a metal inner liner within the drive shaft in addition to or instead of the polymer jacket. In certain embodiments, the metal inner liner is loose at its proximal end, allowing it to rotate in response to the rotation of the drive shaft. Some embodiments including a metallic inner liner may include proximal and / or distal inner stops that allow the metallic inner liner to move longitudinally between the proximal and distal inner stops in embodiments including such stops, or up to the distal inner stop in embodiments including only distal stops.

[0012] Embodiments of the present invention may address problems associated with known rotary devices by providing a rotatable, longitudinally movable polymer jacket surrounding the drive shaft, which minimizes undesirable radial deflection of the drive shaft and damps vibrations better than the fixed polymer jackets of known rotary devices. Additionally or alternatively, the configurations of embodiments of the present invention may reduce or eliminate undesirable vibrations and / or standing waves in the drive shaft during high speed rotation better than the fixed polymer jackets of known rotary devices.

[0013] One embodiment is a medical device comprising a rotatable drive shaft and a polymer jacket partially surrounding the rotatable drive shaft, wherein the polymer jacket does not rotate in response to rotation of the rotatable drive shaft and the polymer jacket is fixed in a longitudinal position.

[0014] A further embodiment is a medical device comprising a rotatable drive shaft and a polymer jacket partially surrounding the rotatable drive shaft, the polymer jacket configured to move rotationally and / or longitudinally independently of the drive shaft in response to rotation of the drive shaft.

[0015] A further embodiment is a rotational atherectomy device comprising: a prime mover having a prime mover drive shaft operatively connected thereto; a rotatable drive shaft; an abrading head disposed on the rotatable drive shaft; and a polymer jacket partially surrounding the rotatable drive shaft, wherein a distal end of the polymer jacket is proximal to the abrading head, and the polymer jacket is configured to move rotationally and / or longitudinally independently of the drive shaft in response to rotation of the drive shaft.

[0016] The description of the present invention and its applications set forth herein is illustrative and is not intended to limit the scope of the invention. Features of various embodiments may be combined with other embodiments within the scope of this invention. Variations and modifications of the embodiments disclosed herein are possible, and practical alternatives and equivalents to the various elements of the embodiments will be apparent to those skilled in the art upon studying this patent document. These and other variations and modifications of the embodiments disclosed herein can be made without departing from the scope and spirit of the invention.

[0017] A brief description of some of the figures in the drawing [Brief explanation of the drawings]

[0018] [Figure 1] 1 is a perspective view of one embodiment of a known rotational atherectomy device and system. [Figure 2] 1 is a partial schematic and partial longitudinal cross-sectional view of one known embodiment of a rotational medical device and system, the cross-section being taken substantially parallel to the longitudinal axis A. FIG. [Figure 3] FIG. 1 is a longitudinal cross-sectional view of one embodiment of the present invention, taken substantially parallel to the longitudinal axis A. [Figure 4] FIG. 2 is a longitudinal cross-sectional view of another embodiment of the present invention, taken substantially parallel to the longitudinal axis A. [Figure 5] 5 is an axial cross-sectional view of the embodiment of FIGS. 3 and 4, showing a cross-section taken substantially perpendicular to the longitudinal axis A. FIG. [Figure 6] FIG. 2 is a longitudinal cross-sectional view of another embodiment of the present invention, taken substantially parallel to the longitudinal axis A. [Figure 7] 7 is an axial cross-sectional view of the embodiment of FIG. 6, showing a cross-section taken substantially perpendicular to the longitudinal axis A. FIG. [Figure 8] FIG. 2 is a longitudinal cross-sectional view of another embodiment of the present invention, taken substantially parallel to the longitudinal axis A. [Figure 9] FIG. 2 is a longitudinal cross-sectional view of another embodiment of the present invention, taken substantially parallel to the longitudinal axis A. DETAILED DESCRIPTION OF THE INVENTION

[0019] Detailed Description of the Invention While the invention is amenable to various modifications and alternative forms, its features have been shown by way of example in the drawings and are herein described in detail. It should be understood, however, that it is not intended to limit the invention to the particular embodiments described. On the contrary, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention. Furthermore, one or more of the embodiments described herein may include a proximal stop, a distal stop, a Although described or illustrated as including each of a stopper, a stopper, and a metal liner, it should be understood that embodiments including less than all of these features are also contemplated within the scope of this disclosure.

[0020] 1-9 show various embodiments of known devices and devices of the present invention. Although these embodiments are shown separately, it will be understood by those skilled in the art that one or more aspects of the shown embodiments may be combined.

[0021] FIG. 1 illustrates one known embodiment of a rotational atherectomy device that may incorporate the present invention. The device includes a handle portion 10, an elongated, flexible drive shaft 20 having an enlarged abrading head 28, and an elongated catheter 13 extending distally from the handle portion 10. The drive shaft 20 is constructed from a helically coiled wire, as known in the art, to which the abrading head 28 is fixedly attached. Known drive shafts, such as the drive shaft 20, are fabricated from a multi-filar wound coil. The coil may comprise any suitable metallic material. The unique configuration of this known coil allows for spaces between the filars. These spaces allow for the passage of fluid, such as saline and / or water, or other fluids, to the inner diameter of the drive shaft coil to provide a cooling and / or lubricating effect at the interface between the drive shaft coil and the guidewire 15.

[0022] Generally, in this known configuration, a coupling (typically comprising a solid metal tube) is attached to the proximal end of the coiled drive shaft and the drive shaft of the handle portion 10. The drive shaft of the handle portion 10 is driven by a prime mover, thereby providing a connection between the prime mover, e.g., a turbine or electric motor, and the drive shaft 20. However, other suitable drive shaft configurations may be used that are compatible with the embodiments of this disclosure without departing from the scope and spirit of the present invention.

[0023] 1 , catheter 13 has a lumen in which most of the length of drive shaft 20 is disposed, except for enlarged abrading head 28 and a short section distal to abrading head 28. Drive shaft 20 also defines an inner lumen that allows drive shaft 20 to advance and rotate over guidewire 15. A fluid supply line 17 may be provided for introducing a cooling and lubricating solution (typically saline or another biocompatible fluid) into catheter 13.

[0024] The handle portion 10 desirably includes a turbine (or similar rotatable drive mechanism) for rotating the drive shaft 20 at high speed. The handle portion 10 may be connected to a power source, typically compressed air delivered through a tube 16. A pair of fiber optic cables 25 may be provided to monitor the speed of rotation of the turbine and drive shaft 20, or alternatively, a single fiber optic cable may be used. The handle portion 10 also desirably 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 portion 10.

[0025] Figure 2 is a partial schematic and partial longitudinal cross-sectional view of one known embodiment of a rotational medical device, the cross-section being taken substantially parallel to the longitudinal axis A. It should be noted that any one or more of the features, functions, and advantages described herein with respect to the rotational medical device of Figure 1 may optionally be included in the rotational medical device of Figure 2, and vice versa. It should also be noted that like reference numerals indicate substantially like features throughout the rotational medical devices of Figures 1 and 2. For example, the drive shaft 20 may be substantially the same in the rotational medical devices of Figures 1 and 2.

[0026] The rotary medical device shown in FIG. 2 includes a drive shaft 20 with wire or metal windings operably connected to a prime mover 30, such as a turbine, pneumatic device, or electric motor. A fluid reservoir 32 is operably and fluidly connected to the system, and an outer polymer jacket 22 is fixed in a longitudinal position at the proximal end of the drive shaft 20 and extends distally to the distal ends of the wire windings of the drive shaft 20. The polymer jacket 22 and the wire windings of the drive shaft 20 terminate at approximately the same location. That is, in the embodiment of FIG. 2, the polymer jacket 22 covers all of the drive shaft 20. The drive shaft 20 rotates independently of and within the polymer jacket 22. Generally, the polymer jacket 22 helps to contain fluid within and / or around the drive shaft 20 during rotation, further helping the drive shaft 20 maintain an operating diameter as close as possible to its resting diameter. Stated differently, the polymer jacket 22 minimizes unwanted radial deflection due to the flexible wire windings of the drive shaft 20 and helps to keep the drive shaft 20 aligned as closely as possible with the stationary nominal axis of rotation A.

[0027] FIG. 3 is a longitudinal cross-sectional view of one embodiment of the present invention, the cross-section being taken substantially parallel to the longitudinal axis A. Elements of the prime mover 30 and fluid reservoir 32 illustrated in FIG. 2 are omitted from FIG. 3 but may be considered part of the system of FIG. 3. A drive shaft 40 is provided having metal wire windings and is partially covered by an outer polymer jacket 42 secured at its proximal end. One or more configurations of the drive shaft 40 and polymer jacket 42 may be substantially similar to the corresponding configurations of the drive shaft 20 and polymer jacket 22 of the embodiment of FIG. 2 (e.g., the wire windings of the drive shaft 20 and / or the composition of the materials forming the drive shaft 20 and polymer jacket 22). The polymer jacket 42 does not rotate; the drive shaft 40 rotates independently within the polymer jacket 42. The embodiment of FIG. 3 differs from the embodiment of FIG. 2 in that a distal section 46 of the drive shaft 40 is exposed and not covered by the polymer jacket 42. This distal section 46 may be provided with a tool, such as an atherectomy crown, e.g., an abrasive head (not shown), or other tool.

[0028] Alternatively, the polymer jacket 42 may not be fixed at its proximal end. In this alternative embodiment of FIG. 3, the polymer jacket 42 is capable of rotating in response to the rotation of the drive shaft 40, but the polymer jacket 42 and the drive shaft 40 are not themselves connected. The drive shaft 40 may include a proximal atraumatic stop 48P and a distal atraumatic stop 48D. The proximal atraumatic stop 48P and the distal atraumatic stop 48D may comprise smooth, atraumatic ridges on the outer surface of the drive shaft 40. Thus, the polymer jacket 42 is longitudinally constrained between the stops 48P and 48D, which may prevent any longitudinal movement of the polymer jacket 42 or allow some longitudinal movement, depending on the distance between the stops 48P and 48D relative to the length of the polymer jacket 42. Further alternatively, only the distal stop 48D may be provided, with the polymer jacket 42 free to move distally up to the distal stop 48D. Further alternatively, proximal stop 48P and / or distal stop 48D may each include more than one ridge, with some of the proximal ridges and / or some of the distal ridges being radially spaced apart from one another around the circumference of the corresponding proximal or distal section of drive shaft 40. In all cases of this embodiment, polymer jacket 42 rotates freely during rotation of drive shaft 40, although not necessarily at the same speed as drive shaft 40.

[0029] This arrangement allows the polymer jacket 42 to rotate freely while the drive shaft 40 rotates. As discussed above, maintaining the outer diameter of the drive shaft 40 at an operating diameter that approximates its resting diameter during rotation and allowing the polymer jacket 42, when properly positioned between the proximal stop 48P and the distal stop 48D, with or without longitudinal movement of the polymer jacket 42 therebetween, helps add additional resonance reduction or mitigation features. For example, allowing the polymer jacket 42 to rotate and longitudinally move between the proximal stop 48P and the distal stop 48D helps reduce undesirable vibration and / or standing wave issues that may arise during high speed rotation of the drive shaft 40 by allowing the polymer jacket 42 to rotate and / or move longitudinally. That is, by allowing the polymer jacket 42 to rotate and / or move longitudinally between the proximal stop 48P and the distal stop 48D, the polymer jacket 42 can rotate and / or slide into a natural position, helping to minimize or eliminate these potential issues.

[0030] In addition to the above benefits, the arrangement of FIG. 3 provides additional stability and support for a guidewire (not shown, but well known to those skilled in the art; e.g., guidewire 15 shown in FIG. 1) that may extend through the lumen of drive shaft 40. It is known that vibrations and other forces can adversely affect the guidewire in addition to the driveshaft, particularly at its distal end. In damping radial deflection of drive shaft 40, polymer jacket 42 also acts to dampen vibrations and other forces imparted to the guidewire in known devices.

[0031] FIG. 4 is a longitudinal cross-sectional view of another embodiment of the present invention, the cross-section being taken substantially parallel to longitudinal axis A. Specifically, the embodiment of FIG. 4 is a variation of the embodiment of FIG. 3. A drive shaft 50 is provided that includes metal wire windings and proximal and distal stops 58P, 58D, with the drive shaft 50 partially covered by a polymer jacket 52, leaving proximal and distal sections 54, 56 of the drive shaft 50 exposed. One or more configurations and advantages of the drive shaft 50, proximal and distal stops 58P, 58D, and polymer jacket 52 may be substantially similar to the corresponding configurations and advantages of the drive shaft 40, stops 48P and 48D, and polymer jacket 42 of the embodiment of FIG. 3. FIG. 4 shows that the proximal stop 58P and the distal stop 58D are spaced apart by a distance greater than the longitudinal length of the polymer jacket 52, thus allowing the polymer jacket 52 a predetermined length of longitudinal movement that corresponds to the rotation and associated radial movement of the drive shaft 50, providing the same benefits to the drive shaft 50 and guidewire as described above.

[0032] Figure 5 is an axial cross-sectional view of the embodiment of Figures 3 and 4, with the cross-section taken substantially perpendicular to longitudinal axis A. As shown in Figure 5, an outer polymer jacket 52 surrounds the inner wire turns of the drive shaft 50. A small circumferential space (not shown) may be defined between the drive shaft 50 and the polymer jacket 52, which may allow for independent rotation of the drive shaft 50 and the polymer jacket 52.

[0033] 6-9 illustrate various embodiments of the rotary medical device of the present disclosure, which include a smooth metal liner disposed within a drive shaft. As described below, the metal liner can be used with or without a polymer jacket. When used with a polymer jacket, both the polymer jacket and the metal liner can optionally be longitudinally fixed to prevent either the polymer jacket or the metal liner from rotating and not connected to the drive shaft, or one or both of the polymer jacket and the metal liner can be configured to rotate independently of the drive shaft.

[0034] FIG. 6 is a longitudinal cross-section of another embodiment of the present invention, the cross-section taken substantially parallel to the longitudinal axis A. A drive shaft 60 is provided having metal wire windings, the drive shaft 60 being partially covered by a polymer jacket 62 such that a distal section 66 and a proximal section 67 of the drive shaft 60 are exposed. The drive shaft 60 includes a proximal stop 68P and a distal stop 68D. One or more configurations and advantages of the drive shaft 60, the stops 68P and 68D, and the polymer jacket 62 may be substantially similar to the corresponding configurations and advantages of the drive shaft, stops, and polymer jacket of the embodiments of FIGS. 3-5. The embodiment of FIG. 6 adds to the embodiments of FIGS. 4 and 5 a smooth metal liner 64 inside the wire windings of the drive shaft 60.

[0035] The smooth metal liner 64 is flexible but is not attached to the drive shaft 60. As shown in FIG. 6 , the drive shaft 60 further includes an inner proximal stop 70P and an inner distal stop 70D. Alternatively, the inner stop of the drive shaft 60 may include only the distal inner stop 70D. The inner stops 70P and 70D include ridges extending radially inward from the inner surface of the drive shaft 60 into the lumen defined by the drive shaft 60. In some cases, the inner proximal stop 70P and / or the inner distal stop 70D may each include more than one ridge, with several proximal ridges and / or several distal ridges radially spaced apart from one another around the inner circumference of the corresponding proximal or distal section 67 or 66 of the drive shaft 60. In such a case, the metal liner 64 is free to move within the drive shaft 60 between the inner proximal stop 70P and / or the inner proximal stop 70D, or between the proximal end of the drive shaft 60 and the inner distal stop 70D, in a manner similar to that described above in connection with the polymer jacket and drive shaft embodiment of Figures 3-5. Thus, the metal liner 64 is capable of longitudinal movement within a predetermined distance. If both the inner proximal stop 70P and the inner distal stop 70D are used, the distance between the proximal stop 70P and the distal stop 70D can be greater than or equal to the length of the metal liner 64 to define the desired longitudinal movement of the metal liner 64.

[0036] Metal liner 64 may help prevent fluid migration in / out of the lumen defined by drive shaft 60 and may also provide advantages related to those discussed above for rotatable / longitudinally movable polymer jackets with respect to minimizing resonance, vibration, etc., thereby helping to maintain the integrity of drive shaft 60 and the guidewire, which may move and / or rotate within and relative to metal liner 64. In some embodiments, metal liner 64 may have a stiffness that is different (e.g., greater) than the stiffness of polymer jacket 62 and / or the other polymer jackets discussed above to provide a desired amount of flexibility to a device including metal liner 64.

[0037] Figure 7 is an axial cross-sectional view of the embodiment of Figure 6, with the cross-section taken substantially perpendicular to the longitudinal axis A. As shown in Figure 7, an outer polymer jacket 62 surrounds the inner wire turns of the drive shaft 60. A small circumferential space (not shown) may be defined between the metal liner 64 and the drive shaft 60, which may allow for independent rotation of the drive shaft 60 and the metal liner 64. A small circumferential space (not shown) may be defined between the drive shaft 60 and the polymer jacket 62, which may allow for independent rotation of the drive shaft 60 and the polymer jacket 62.

[0038] 8 is a longitudinal cross-sectional view of another embodiment of the present invention, the cross-section being taken substantially parallel to the longitudinal axis A. A drive shaft 80 is provided having metal wire windings, the drive shaft 80 having a distal section 86 and a proximal section 88 of the drive shaft 60. 4 and 5, the drive shaft 80 is partially covered by a polymer jacket 82 so that a portion of the wire windings 87 is exposed. The drive shaft 80 includes a proximal stop 88P and a distal stop 88D. One or more configurations and advantages of the drive shaft 80, stops 88P and 88D, and polymer jacket 82 may be substantially similar to the corresponding configurations and advantages of the drive shaft and polymer jacket of the embodiments of FIGS. 3-5. The embodiment of FIG. 8 adds to the embodiments of FIGS. 4 and 5 a smooth metal liner 84 inside the wire windings of the drive shaft 80.

[0039] The smooth metal liner 84 is flexible and fixed at its proximal end. Unlike the embodiment of FIG. 6, the drive shaft 80 does not include an inner proximal stop and / or an inner distal stop, allowing longitudinal movement of the metal liner 84 therebetween. When the metal liner 84 is fixed at its proximal end, the metal liner 84 does not rotate, and the drive shaft 80 and polymer jacket 82 rotate independently on the metal liner 84. Alternatively, the smooth metal liner 84 may not be fixed at its proximal end. In such a case, the metal liner 84 rotates freely within the drive shaft 80 during rotation of the drive shaft 80.

[0040] 9 is a longitudinal cross-sectional view of another embodiment of the present invention, the cross-section being taken substantially parallel to longitudinal axis A. A drive shaft 90 is provided having metal wire windings, the drive shaft 90 being partially covered by a polymer jacket 92 such that a distal section 96 and a proximal section 97 of the drive shaft 90 are exposed. The embodiment of FIG. 9 adds to the embodiment of FIG. 2 a smooth metal liner 94 inside the wire windings of the drive shaft 90. One or more configurations and advantages of the drive shaft 90 and polymer jacket 92 may be substantially similar to the corresponding configurations and advantages of the drive shaft and polymer jacket of the embodiment of FIG. 2.

[0041] The smooth metal liner 94 is flexible and is not attached to the drive shaft 90. As shown in FIG. 9 , the drive shaft 90 further includes an inner proximal stop 100P and an inner distal stop 100D. Alternatively, the inner stop of the drive shaft 90 may include only a distal inner stop 100D. Similar to the inner stops 70P and 70D of the embodiment of FIG. 6 , the inner stops 100P and 100D include ridges extending radially inward from the inner surface of the drive shaft 90 into the lumen defined by the drive shaft 90. In some cases, the inner proximal stop 100P and / or the inner distal stop 100D may each include more than one ridge, with several proximal ridges and / or several distal ridges radially spaced apart from one another around the inner circumference of the corresponding proximal or distal section 97 or 96 of the drive shaft 90. In such a case, the metal liner 94 is free to move within the drive shaft 90 between the inner proximal stop 100P and / or the inner proximal stop 100D, or between the proximal end of the drive shaft 90 and the inner distal stop 100D, in a manner similar to that described above in connection with the polymer jacket and drive shaft of the embodiment of Figures 3-5. Thus, the metal liner 94 is capable of longitudinal movement within a predetermined distance. If both the inner proximal stop 100P and the inner distal stop 100D are used, the distance between the proximal stop 100P and the distal stop 100D may be greater than or equal to the length of the metal liner 94 to define the desired longitudinal length of movement of the metal liner 94. Thus, the metal liner may provide any or all of the advantages described above in connection with the metal liner 64 of the embodiment of Figure 6.

[0042] Unlike the embodiment of FIG. 8, the drive shaft 80 does not include an outer proximal stop and / or an outer distal stop to allow longitudinal movement of the polymer jacket 92 therebetween. The polymer jacket does not rotate, and the drive shaft 90 and metal liner 94 rotate independently within the polymer jacket 92. Alternatively, the polymer jacket 92 may not be fixed at its proximal end. In such a case, the polymer jacket 92 rotates freely on the drive shaft 90 during rotation of the drive shaft 90. The polymer jacket 92 of FIG. 9 may provide one or more of the advantages of the polymer jackets of FIGS. 2-8.

[0043] The description of the present invention and its applications set forth herein is illustrative and is not intended to limit the scope of the invention. Features of various embodiments may be combined with other embodiments within the scope of this invention. Variations and modifications of the embodiments disclosed herein are possible, and practical alternatives and equivalents to the various elements of the embodiments will be apparent to those skilled in the art upon studying this patent document. These and other variations and modifications of the embodiments disclosed herein can be made without departing from the scope and spirit of the invention. It should be noted that the present specification discloses the following aspects. [Aspect 1] a rotatable drive shaft; a polymer jacket partially surrounding the rotatable drive shaft; A medical device wherein the polymer jacket does not rotate in response to rotation of the rotatable drive shaft, and the polymer jacket is fixed in longitudinal position. [Aspect 2] 10. The medical device of embodiment 1, further comprising a flexible metal liner within a lumen defined by the rotatable drive shaft. [Aspect 3] 3. The medical device of embodiment 2, further comprising the flexible metal liner fixed in place both rotationally and longitudinally. [Aspect 4] 3. The medical device of embodiment 2, further comprising the flexible metal liner adapted for rotational and / or longitudinal movement independent of the drive shaft. [Aspect 5] A medical device as described in aspect 4, wherein the flexible metal liner is adapted to move longitudinally independently from the drive shaft, the drive shaft including an inner distal stop extending from an inner surface of a distal portion of the drive shaft into the lumen defined by the drive shaft, the inner distal stop limiting longitudinal movement of the flexible metal liner in the distal direction to the inner distal stop. [Aspect 6] A medical device as described in aspect 5, wherein the drive shaft further comprises an inner proximal stop extending from the inner surface of the proximal portion of the drive shaft into the lumen defined by the drive shaft, the inner proximal stop and the inner distal stop limiting longitudinal movement of the flexible metal liner between the inner proximal stop and the inner distal stop. [Aspect 7] a rotatable drive shaft; a polymer jacket partially surrounding the rotatable drive shaft; The medical device, wherein the polymer jacket is configured to move rotationally and / or longitudinally independently of the drive shaft in response to rotation of the drive shaft. [Aspect 8] 8. The medical device of embodiment 7, further comprising a flexible metal liner within the lumen of the rotatable drive shaft. [Aspect 9]

[0023] Embodiment 9. The medical device of embodiment 8, further comprising the flexible metal liner fixed in place both rotationally and longitudinally. [Aspect 10] 9. The medical device of embodiment 8, further comprising the flexible metal liner adapted for rotational and / or longitudinal movement independent of the drive shaft. [Aspect 11]

[0023] Aspect 9. The medical device of aspect 8, further comprising the flexible metal liner adapted for rotational and / or longitudinal movement independent of both the drive shaft and the polymer jacket. [Aspect 12] The flexible metal liner is adapted to move longitudinally independent of the drive shaft, the drive shaft including an inner distal stop extending from an inner surface of a distal portion of the drive shaft into the lumen defined by the drive shaft, the inner distal stop restricting longitudinal movement of the flexible metal liner in a distal direction relative to the inner distal stop. 12. The medical device of embodiment 11, wherein the medical device is limited to a fastener. [Aspect 13] A medical device as described in aspect 12, wherein the drive shaft further comprises an inner proximal stop extending from the inner surface of the proximal portion of the drive shaft into the lumen defined by the drive shaft, the inner proximal stop and the inner distal stop limiting longitudinal movement of the flexible metal liner between the inner proximal stop and the inner distal stop. [Aspect 14] A medical device as described in aspect 7, wherein the polymer jacket is adapted to move longitudinally independently from the drive shaft, the drive shaft including an outer distal stop extending radially outward from an outer surface of a distal portion of the drive shaft, the outer distal stop limiting longitudinal movement of the polymer jacket in the distal direction to the outer distal stop. [Aspect 15] A medical device as described in aspect 14, wherein the drive shaft further comprises an outer proximal stop extending radially outward from the outer surface of the proximal portion of the drive shaft, the outer proximal stop and the outer distal stop limiting longitudinal movement of the polymer jacket between the outer proximal stop and the outer distal stop. [Aspect 16] a prime mover having a prime mover drive shaft operatively connected thereto; a rotatable drive shaft; a polishing head mounted on the rotatable drive shaft; a polymer jacket partially surrounding the rotatable drive shaft, the distal end of the polymer jacket being proximal to the polishing head; A rotational atherectomy device, wherein the polymer jacket is configured to move rotationally and / or longitudinally independently of the drive shaft in response to rotation of the drive shaft. [Aspect 17] 17. The rotational atherectomy device of embodiment 16, further comprising a flexible metal liner within the lumen of the rotatable drive shaft. [Aspect 18] 20. The rotational atherectomy device of embodiment 17, further comprising the flexible metal liner fixed in place both rotationally and longitudinally. [Aspect 19] 20. The rotational atherectomy device of embodiment 17, further comprising the flexible metal liner adapted for rotational and / or longitudinal movement independent of the drive shaft. [Aspect 20] 20. The rotational atherectomy device of embodiment 17, further comprising the flexible metal liner adapted for rotational and / or longitudinal movement independent of both the drive shaft and the polymer jacket. [Aspect 21] A rotational atherectomy device as described in aspect 20, wherein the flexible metal liner is adapted to move longitudinally independently from the drive shaft, the drive shaft having an inner distal stop extending from the inner surface of a distal portion of the drive shaft into the lumen defined by the drive shaft, the inner distal stop limiting the longitudinal movement of the flexible metal liner in the distal direction to the inner distal stop. [Aspect 22] The drive shaft further comprises an inner proximal stop extending from an inner surface of a proximal portion of the drive shaft into the lumen defined by the drive shaft, 22. The rotational atherectomy device of claim 21, wherein a proximal stop and the inner distal stop limit longitudinal movement of the flexible metal liner between the inner proximal stop and the inner distal stop. [Aspect 23] A rotational atherectomy device as described in aspect 16, wherein the polymer jacket is adapted to move longitudinally independently from the drive shaft, the drive shaft having an outer distal stop extending radially outward from the outer surface of the distal portion of the drive shaft, the outer distal stop limiting the longitudinal movement of the polymer jacket in the distal direction to the outer distal stop. [Aspect 24] A rotational atherectomy device as described in aspect 23, wherein the drive shaft further comprises an outer proximal stop extending radially outward from the outer surface of the proximal portion of the drive shaft, the outer proximal stop and the outer distal stop limiting longitudinal movement of the polymer jacket between the outer proximal stop and the outer distal stop.

Claims

1. a rotatable drive shaft; a polymer jacket partially surrounding at least a portion of the length of the rotatable drive shaft; the polymer jacket does not rotate in response to rotation of the rotatable drive shaft, and the polymer jacket is restricted in longitudinal movement relative to the rotatable drive shaft; further comprising a flexible metal liner within a lumen defined by the rotatable drive shaft, the flexible metal liner defining a lumen configured to accommodate a guidewire; the flexible metal liner is adapted to move longitudinally independent of the rotatable drive shaft, and the rotatable drive shaft is adapted to rotate within the polymer jacket independent of the flexible metal liner; the drive shaft includes an inner distal stop extending from an inner surface of a distal portion of the drive shaft into the lumen defined by the drive shaft, the inner distal stop limiting longitudinal movement of the flexible metal liner in a distal direction to the inner distal stop; Medical devices.

2. 2. The medical device of claim 1, wherein the drive shaft further comprises an inner proximal stop extending from an inner surface of a proximal portion of the drive shaft into the lumen defined by the drive shaft, the inner proximal stop and the inner distal stop limiting longitudinal movement of the flexible metal liner between the inner proximal stop and the inner distal stop.

3. a rotatable drive shaft; a polymer jacket partially surrounding at least a portion of the length of the rotatable drive shaft; the polymer jacket is configured to move rotationally and / or longitudinally relative to the rotatable drive shaft independently of the drive shaft; further comprising a flexible metal liner within the lumen of the rotatable drive shaft, the flexible metal liner defining a lumen configured to accommodate a guidewire; the flexible metal liner is adapted to move longitudinally independent of the rotatable drive shaft, and the rotatable drive shaft is adapted to rotate within the polymer jacket independent of the flexible metal liner; the flexible metal liner is limited in distal movement relative to the drive shaft; A medical device, wherein the drive shaft includes an inner distal stop extending from an inner surface of a distal portion of the drive shaft into the lumen defined by the drive shaft, the inner distal stop limiting longitudinal movement of the flexible metal liner in the distal direction to the inner distal stop.

4. 4. The medical device of claim 3, wherein the drive shaft further comprises an inner proximal stop extending from an inner surface of a proximal portion of the drive shaft into the lumen defined by the drive shaft, the inner proximal stop and the inner distal stop limiting longitudinal movement of the flexible metal liner between the inner proximal stop and the inner distal stop.

5. 4. The medical device of claim 3, wherein the drive shaft includes an outer distal stop extending radially outward from an outer surface of a distal portion of the drive shaft, the outer distal stop limiting longitudinal movement of the polymer jacket in a distal direction to the outer distal stop.

6. 6. The medical device of claim 5, wherein the drive shaft further comprises an outer proximal stop extending radially outward from an outer surface of the proximal portion of the drive shaft, the outer proximal stop and the outer distal stop limiting longitudinal movement of the polymer jacket between the outer proximal stop and the outer distal stop.

7. a prime mover having a prime mover drive shaft operatively connected thereto; a rotatable drive shaft; a polishing head mounted on the rotatable drive shaft; a polymer jacket partially surrounding at least a portion of the length of the rotatable drive shaft, the distal end of the polymer jacket being proximal to the polishing head; the polymer jacket is configured to move rotationally and / or longitudinally independent of the drive shaft relative to rotation of the drive shaft; further comprising a flexible metal liner within the lumen of the rotatable drive shaft; the flexible metal liner is fixedly secured in a predetermined longitudinal position relative to the rotatable drive shaft, the rotatable drive shaft being adapted to rotate within the polymer jacket independently of the flexible metal liner; the drive shaft includes an inner distal stop extending from an inner surface of a distal portion of the drive shaft into the lumen defined by the drive shaft, the inner distal stop limiting longitudinal movement of the flexible metal liner in a distal direction to the inner distal stop; Rotational atherectomy device.

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