阅读说明：本技术 组织移除导管 (Tissue removal catheter ) 是由 M·弗莱明 A·詹莫斯 J·凯利 C·麦克马伦 C·米德 G·卡罗尔 于 2018-05-03 设计创作，主要内容包括：一种用于移除体腔中的组织的组织移除导管包括细长主体(12),该细长主体具有轴线以及沿着该轴线彼此间隔开的近端部分和远端部分。细长主体(12)的尺寸和形状设定成接纳在体腔中。手柄(40)安装于细长主体(12)的近端部分并且可操作成使得细长主体的旋转。组织移除元件安装在细长主体(12)的远端部分上。内衬套(14)接纳在细长主体(12)内,并且在内衬套(14)的近端处联接于手柄(40)。传感器相对于细长主体(12)和内衬套(14)布置并构造成检测由细长主体(12)在使用期间接触内衬套(14)引起的内衬套(14)的磨损。(A tissue-removing catheter for removing tissue in a body lumen includes an elongate body (12) having an axis and proximal and distal portions spaced apart from one another along the axis. The elongated body (12) is sized and shaped to be received in a body cavity. A handle (40) is mounted to a proximal portion of the elongated body (12) and is operable to cause rotation of the elongated body. A tissue-removing element is mounted on a distal portion of the elongate body (12). An inner liner (14) is received within the elongated body (12) and is coupled to the handle (40) at a proximal end of the inner liner (14). The sensor is arranged relative to the elongate body (12) and the inner liner (14) and is configured to detect wear of the inner liner (14) caused by the elongate body (12) contacting the inner liner (14) during use.)

1. a tissue-removing catheter for removing tissue in a body lumen, the tissue-removing catheter comprising:

An elongated body having an axis and proximal and distal portions spaced apart from each other along the axis, the elongated body sized and shaped to be received in the body lumen;

A handle mounted to the proximal portion of the elongated body and operable to cause rotation of the elongated body;

a tissue-removing element mounted on the distal end portion of the elongate body, the tissue-removing element configured to remove the tissue as the elongate tissue rotates the tissue-removing element within the body lumen;

an inner sleeve received within the elongate body and coupled to the handle at a proximal end of the inner sleeve, the inner sleeve defining a guidewire lumen; and

A sensor disposed relative to the elongated body and the inner liner and configured to detect wear of the inner liner caused by the elongated body contacting the inner liner during use.

2. the tissue-removing catheter set forth in claim 1, wherein the sensor provides an indication of at least one of: when the elongate body is in contact with a guidewire received in the guidewire lumen of the inner liner, and when a portion of the inner liner is in contact with a guidewire received in the guidewire lumen of the inner liner.

3. the tissue-removing catheter set forth in claim 2, wherein the sensor comprises a first contact associated with the elongate body and a second contact associated with the guidewire, the first contact in electrical communication with the second contact to indicate wear of the inner liner.

4. The tissue-removing catheter set forth in claim 3, wherein the handle includes a motor and a drive operably connecting the motor to the elongate body to rotate the elongate body, the first contact being attached to the drive.

5. the tissue-removing catheter set forth in claim 4, wherein the handle includes a guidewire lock configured to lock the guidewire in place relative to the handle, the second contact being attached to the guidewire lock.

6. The tissue-removing catheter set forth in claim 5, wherein the second contact is directly attached to the guidewire lock.

7. The tissue-removing catheter set forth in claim 5, further comprising a connector attached to the handle, wherein the second contact is directly attached to the connector.

8. The tissue-removing catheter set forth in claim 4, wherein the drive member includes a drive shaft and a drive key connected to the drive shaft, the first contact being attached to the drive key.

9. The tissue-removing catheter set forth in claim 2, wherein the sensor comprises a first contact associated with the inner liner and a second contact associated with the guidewire, the first contact in electrical communication with the second contact to indicate wear of the inner liner.

10. The tissue-removing catheter set forth in claim 1, wherein the distal end of the inner sleeve extends distally of the tissue-removing element.

11. The tissue-removing catheter set forth in claim 1, further comprising a motor located in the handle and operatively engaged with the elongate body for driving rotation of the elongate body and the tissue-removing element mounted thereon.

12. A tissue-removing catheter for removing tissue in a body lumen, the tissue-removing catheter comprising:

An elongated body having an axis and proximal and distal portions spaced apart from each other along the axis, the elongated body sized and shaped to be received in the body lumen;

A tissue-removing element mounted on the distal end portion of the elongate body, the tissue-removing element configured to remove the tissue as the elongate tissue rotates the tissue-removing element within the body lumen;

An inner liner received within the elongate body, the inner liner defining a guidewire lumen; and

A sensor disposed relative to the elongated body and the inner liner and configured to detect wear of the inner liner caused by the elongated body contacting the inner liner during use.

13. The tissue-removing catheter set forth in claim 12, wherein the sensor provides an indication of at least one of: when the elongate body is in contact with a guidewire received in the guidewire lumen of the inner liner, and when a portion of the inner liner is in contact with a guidewire received in the guidewire lumen of the inner liner.

14. the tissue-removing catheter set forth in claim 13, wherein the sensor comprises a first contact associated with the elongate body and a second contact associated with the guidewire, the first contact in electrical communication with the second contact to indicate wear of the inner liner.

15. The tissue-removing catheter set forth in claim 14, further comprising a motor and a drive operably connecting the motor to the elongate body to rotate the elongate body, the first contact attached to the drive.

16. The tissue-removing catheter set forth in claim 15, further comprising a guidewire lock configured to lock the guidewire in place, the second contact being attached to the guidewire lock.

17. the tissue-removing catheter set forth in claim 16, wherein the drive member includes a drive shaft and a drive key connected to the drive shaft, the first contact being attached to the drive key.

18. The tissue-removing catheter set forth in claim 13, wherein the sensor comprises a first contact associated with the inner liner and a second contact associated with the guidewire, the first contact in electrical communication with the second contact to indicate wear of the inner liner.

19. A method of removing tissue in a body lumen, the method comprising:

Advancing a tissue-removing catheter over a guidewire in the body lumen to position a distal end of the catheter adjacent the tissue and to position a proximal portion of the catheter outside the body lumen, the catheter including an elongate body, a tissue-removing element mounted on a distal portion of the elongate body, and an inner liner disposed within the elongate body, the inner liner defining a guidewire lumen in which the guidewire is disposed during advancement of the catheter;

Rotating the elongate body of the catheter and the tissue-removing element to remove the tissue; and

Detecting wear of the inner liner caused by the elongated body contacting the inner liner during use.

20. The method of claim 19, further comprising detecting wear of the inner liner using a sensor disposed relative to the elongate body and the inner liner, wherein the sensor includes a first contact associated with one of the elongate body and the inner liner and a second contact associated with the wire, the first contact in electrical communication with the second contact to indicate wear of the inner liner.

Referring to the drawings, and in particular to FIG. 1, a rotary tissue removal catheter for removing tissue in a body lumen is generally indicated by reference numeral 10. The illustrated catheter 10 is an atherectomy device adapted to remove (e.g., abrade, cut, resect, ablate, etc.) occlusive tissue (e.g., embolic tissue, plaque tissue, atherosclerosis, thrombolysis tissue, stenotic tissue, hyperplastic tissue, neoplastic tissue, etc.) from a vessel wall (e.g., a coronary artery wall, etc.). The catheter 10 may be used to facilitate percutaneous coronary angioplasty (PTCA) or subsequent stent delivery. Features of the disclosed embodiments may also be suitable for treating Chronic Total Occlusion (CTO) of blood vessels, as well as strictures of other body lumens such as ureters, biliary tracts, respiratory tracts, pancreatic ducts, lymphatic vessels, and the like, and strictures of other proliferative and neoplastic diseases in other body lumens. Tumors surrounding and invading body cavities often result in the growth of neoplastic cells. Thus, removing such material may be beneficial for maintaining patency of the body cavity.

The catheter 10 is sized to be received in a blood vessel of a subject. Thus, the maximum dimension of the catheter 10 may be 3, 4, 5, 6, 7, 8, 9, 10, or 12 French (1, 1.3, 1.7, 2, 2.3, 2.7, 3, 3.3, or 4 millimeters) and the working length may be 20, 30, 40, 60, 80, 100, 120, 150, 180, or 210 centimeters, depending on the body lumen. While the remaining discussion is directed to a catheter for removing tissue in a blood vessel, it should be understood that the teachings of the present disclosure are also applicable to other types of tissue removal catheters, including, but not limited to, catheters for penetrating and/or removing tissue from various occlusions, stenoses, or proliferations in various body lumens.

referring to fig. 1 and 2, a catheter 10 includes an elongate outer layer 12 (broadly, an elongate body) disposed about an elongate inner liner 14. The outer layer 12 and the inner liner 14 extend along a longitudinal axis LA of the catheter from a proximal portion 16 to a distal portion 18 of the catheter. A tissue-removing element 20 is disposed on the distal end of the outer layer 12 and is configured to rotate to remove tissue from a body lumen, as will be described in more detail below. A sleeve 22 (fig. 1) is disposed about outer layer 12. Both outer layer 12 and inner liner 14 are configured to translate relative to sleeve 22. Outer layer 12 and inner liner 14 are also configured to translate relative to one another. The catheter 10 is sized and shaped for insertion into a body lumen of a subject. The sleeve 22 isolates the body cavity from at least a portion of the outer layer 12 and the inner liner 14. The inner liner 14 defines a guidewire lumen 24 (fig. 5) for slidably receiving a guidewire 26 within the guidewire lumen 24 such that the catheter 10 can be advanced through a body lumen by traveling along the guidewire. The guidewire may be a standard 0.014 inch outer diameter, 300 centimeter long guidewire. In certain embodiments, inner liner 14 may have a lubricious inner surface for sliding over guidewire 26 (e.g., the lubricious surface may be provided by a lubricious polymer layer or a lubricious coating). In the illustrated embodiment, the guidewire lumen 24 extends from the proximal portion 16 of the catheter 10 through the distal portion 18 such that the guidewire 26 may extend along the entire working length of the catheter 10. In one embodiment, the total working length of the catheter 10 may be between about 135 centimeters (53 inches) to about 142 centimeters (56 inches).

The catheter 10 also includes a handle 40 secured at the proximal portion 16 of the catheter. Handle 40 supports an actuator 42 (e.g., a lever, button, dial, switch, or other device), which actuator 42 is configured for selectively actuating a motor 43 disposed in the handle to drive rotation of outer layer 12 and tissue-removing element 20 mounted at the distal end of the outer layer. Motor 43 is coupled to outer layer 12 by a gear assembly 44 and a drive member 48 supported by handle 40. A slider or advancer 45 is positioned on the handle 40 and is operatively coupled to the outer layer 12 to move the outer layer relative to the handle to advance and retract the outer layer and the tissue removal element 20. The handle 40 defines a slot (not shown) that limits movement of the slider 45 relative to the handle. The length of the slot thus determines the amount of relative movement between the outer layer 12 and the handle 40. An irrigation port 46 may be provided at the proximal end 10 of the catheter 16. A port 46 communicates with the space between the sleeve 22 and the outer layer 12 for delivering a fluid (e.g., saline) to cool the rotating outer layer during use. Proximal port 47 allows guidewire 26 and inner liner 14 to pass through the proximal end of handle 40. A guidewire lock 49 (fig. 1A) may be provided on the handle 40 to lock the guidewire 26 in place relative to the handle.

the controller 50 may be provided in the handle 40. The controller 50 may be programmed to detect a signal indicating that contact has occurred between the guidewire 26 and the outer layer 12. Such contact may be due to wear of a portion of inner liner 14 during use. The controller 50 may be configured to generate an alert signal (e.g., an audible sound, a visual indication, etc.) when contact of the outer layer with the guidewire is detected. Bushing wear detection may be accomplished by creating one of a positive terminal and a negative terminal in the outer layer 12 and the other of the positive terminal and the negative terminal in the guide wire 26. Inner liner 14 is disposed between guidewire 26 and outer layer 12. Thus, if inner sleeve 14 is intact, the sleeve will space wire 26 from outer layer 12 and thereby space the terminals associated with the wire from the terminals associated with the outer layer, thereby preventing the circuit from completing. However, the material of the inner sleeve degrades to the extent that the wire 26 is able to contact the outer layer 12 in the worn region of the inner sleeve due to any wear in the inner sleeve 14, and then the metal-to-metal contact of the wire and the outer layer will place the terminal in electrical contact and constitute a sleeve wear circuit. The controller 50 is in electrical communication with the terminals such that the controller can identify a complete circuit that indicates that at least a portion of the bushing has worn. The controller 50 may then signal the alert section 57 to signal that bushing wear has occurred. Alternatively, the alarm portion 57 may also be part of the circuit as shown in FIG. 1A, such that when the circuit is closed, an alarm is automatically signaled.

referring to fig. 1 and 1A, the wire lock 49 may include a terminal 59, such as a negative terminal, for association with the wire 26. Thus, when the guidewire lock is mated 49 to lock guidewire 26 in place, the guidewire lock is in contact with the guidewire so that terminal 59 in the guidewire lock is also in electrical contact with the guidewire. The drive key 53 on the drive shaft 55 of the driver 48 may also include a terminal 61, such as a positive terminal, for association with the outer layer 12. The drive key 53 is in contact with the outer layer 12 and connects the outer layer to the drive shaft 55 and the motor 43. Thus, during normal operation of catheter 10, inner sleeve 14 spaces and isolates guidewire 26 from outer layer 12, thereby preventing the terminals from making electrical contact with each other. This creates an open circuit without current flowing between the terminals. However, if inner sleeve 14 wears to the extent that guidewire 26 can contact outer layer 12, metal-to-metal contact between the components will place the terminals in electrical communication in which current flows between the two terminals closing a circuit. In the event that the circuit is closed, the warning member 57 warns the user of the bushing wear condition.

alternatively, a connector (not shown) including a terminal may be attached to the guide wire lock 49. For example, the connector may be attached to the proximal end of the handle 40 over the guidewire lock 49 to place the terminal in the connector in contact with the guidewire 26.

in some embodiments, a barrier coating may be applied to the guidewire 26 in addition to or in lieu of the inner liner 14. The bushing wear circuit may also be used to indicate that the guide wire coating has worn. In this embodiment, as described above, one of the positive and negative terminals is associated with the guidewire 26, while the other of the positive and negative terminals is associated with the outer layer 12.

Additionally or alternatively, one of the positive and negative terminals may be associated with the inner sleeve 14 and the other of the positive and negative terminals may be associated with the outer layer 12. For example, the terminals associated with inner liner 14 may be attached to the interior or inner surface of the liner, such as middle layer 62, and the terminals associated with outer layer 12 may be attached to drive shaft 55 and drive key 53. In this embodiment, the rubbing of outer layer 12 on the outer surface of inner liner 14 may wear the liner, exposing the interior or inner surface of the liner, thereby forming a metal-to-metal contact to complete the liner wear circuit.

It should be understood that in other embodiments, other suitable actuators, including but not limited to touch screen actuators, wireless controlled actuators, automatic actuators guided by a controller, etc., may be suitable for selectively actuating the motors. In some embodiments, the power supply may come from a battery 63 housed within the handle 40. The battery 63 may provide a source of current for the bushing wear circuit. In other embodiments, the power supply may also be from an external source.

referring to fig. 1 and 3, the outer cannula 22 includes a tubular sleeve configured to isolate and protect arterial tissue within a body lumen of a subject from the rotating outer layer 12. The sleeve 22 is fixed to the handle 40 at the proximal end of the sleeve and does not rotate. An interface 52 mounted on the proximal end of the cannula 22 attaches the cannula to the handle 40. The hub 52 includes a locking feature 54 (e.g., a threaded luer lock), the locking feature 54 for engaging the handle 40 to attach the cannula 22 to the handle. The sleeve 22 provides a partial enclosure for movement of the outer layer 12 and inner liner 14 within the sleeve. The inner diameter of the sleeve 22 is sized to provide clearance for the outer layer 12. The space between the sleeve 22 and the outer layer 12 allows the outer layer to rotate within the sleeve and provides an area for saline infusion between the sleeve and the outer layer. The outer diameter of the cannula 22 is sized to provide clearance with the inner diameter of a guide catheter (not shown) used to deliver the catheter 10 to a desired location in a body lumen. A strain relief 56 is provided at the proximal end of the sleeve 22 to relieve tension applied to the proximal end of the sleeve 22 as the sleeve bends during use of the catheter 10. In one embodiment, the cannula 22 has an inner diameter of about 0.050 inches (1.27 millimeters), an outer diameter of about 0.055 inches (1.4 millimeters), and a length of about 1500 millimeters (59 inches). The sleeve 22 may have other dimensions without departing from the scope of the present disclosure. In one embodiment, the outer sleeve 22 is made of Polytetrafluoroethylene (PTFE). Alternatively, the outer sleeve 22 may comprise a multi-layer construction. For example, the outer sleeve 22 may include an inner layer of Perfluoroalkoxy (PFA), an intermediate braided wire layer, and an outer layer of Pebax.

Referring to fig. 1, 2, 4 and 5, outer layer 12 may comprise a tubular stainless steel coil configured to transmit rotation and torque from motor 43 to tissue-removing element 20. Configuring the outer layer 12 into a coiled configuration, thereby provides flexibility to the outer layer that facilitates delivery of the catheter 10 through a body lumen. Further, the coil configuration allows rotation and torque of the outer layer 12 to be applied to the tissue-removing element 20 as the catheter 10 traverses a tortuous path. The stiffness of the outer layer 12 also affects the ease with which the coil traverses the body lumen and the ability of the coil to effectively transfer torque to the tissue-removing element 20. In one embodiment, the outer layer 12 is relatively rigid such that axial compression and extension of the coil is minimized during movement of the catheter 10 through a body lumen. The coil configuration of outer layer 12 is also configured to expand its inner diameter as the coil rotates so that the outer layer remains spaced from inner liner 14 during operation of catheter 10. In one embodiment, the outer layer 12 has an inner diameter of about 0.023 inches (0.6 millimeters) and an outer diameter of 0.035 inches (0.9 millimeters). The outer layer 12 may have a single layer configuration. For example, the outer layer may comprise a 7-filament (i.e., wire) coil having a lay angle of about 30 degrees. Alternatively, the outer layer 12 may be constructed from multiple layers without departing from the scope of the present disclosure. For example, the outer layer 12 may include a base coil layer and a sheath (e.g., Tecothane) disposed over the base layer^TM). In one embodiment, the outer layer comprises 15-wire coils having a lay angle of about 45 degrees. Tecothane^TMA sheath may be disposed over the coil. Alternatively, the outer layer 12 may comprise a dual coil layer configuration that also includes an additional jacket layer over the two coil layers. For example, the outer layer may include an inner coil layer comprising a 15-wire coil having a lay angle of about 45 degrees and an outer coil layer comprising a 19-wire coil having a lay angle of about 10 degrees. Outer layers having other configurations are also contemplated.

referring to fig. 1, 2, and 4-6, inner liner 14 includes a multi-layered tubular body configured to isolate guidewire 26 from outer layer 12 and tissue-removing element 20. Inner liner 14 may extend through handle 40 from a position proximal to the handle to a position distal to the handle. In one embodiment, inner liner 14 is coupled to handle 40, but is not fixedly attached to handle 40 to allow inner liner to translate relative to the handle. In this embodiment, rotation of inner liner 14 is not prevented. However, the gap between inner liner 14 and outer layer 12 prevents any rotation of the inner liner caused by rotation of the outer layer. In this embodiment, both inner liner 14 and outer layer 12 are allowed to translate relative to handle 40. Allowing this co-translation of inner liner 14 and outer layer 12 minimizes compression and extension of coiled outer layer 14 when a force is applied to the outer layer to move the outer layer within the body lumen. In another embodiment, inner liner 14 may be fixedly attached to handle 40 to prevent relative movement between the inner liner and the handle. Thus, in this embodiment, inner liner 14 remains stationary and inner liner 14 is prevented from translating relative to handle 40. Furthermore, all rotation of inner liner 14 is prevented. In this embodiment, outer layer 12 translates over stationary inner liner 14.

inner liner 14 has an inner diameter sized to pass guidewire 26. Inner liner 14 protects the guidewire from damage caused by rotation of outer layer 12 by isolating the guidewire from the rotatable outer layer. Inner sleeve 14 also extends past tissue-removing element 20 to protect guidewire 26 from the rotating tissue-removing element. Thus, inner liner 14 is configured to prevent any contact between guidewire 26 and rotating components of catheter 10. Thus, inner liner 14 eliminates any metal-to-metal fit. This isolation of the outer layer 12 and tissue removal element 20 from the guidewire 26 also ensures that rotation of the outer layer and tissue removal element is not transferred or transmitted to the guidewire. As a result, a standard guidewire 26 may be used with the catheter 10 because the guidewire does not have to be configured to withstand the twisting action of the rotating components. In addition, by extending through tissue-removing element 20 and past the distal end of the tissue-removing element, inner sleeve 14 stabilizes the tissue-removing element by providing a centering shaft for rotating the tissue-removing element about the inner sleeve.

In the illustrated embodiment, inner liner 14 includes an inner PTFE layer 60, an intermediate braid layer 62 composed of stainless steel, and an outer polyimide layer 64. The PTFE inner layer 60 provides a lubricious interior to the inner liner 14 that facilitates passage of the guidewire 26 therethrough. The braided stainless steel intermediate layer 62 provides rigidity and strength to the inner liner 14 so that the liner can withstand torsional forces exerted by the outer layer 12 on the inner liner. In one embodiment, the intermediate layer 62 is formed from 304 stainless steel. The polyimide outer layer 64 provides wear resistance and has lubricity that reduces friction between the inner liner 14 and the outer layer 12. In addition, a lubricating film such as silicone may be added to inner liner 14 to reduce friction between the inner and outer layers 12. In one embodiment, inner liner 14 has an inner diameter ID of about 0.016 inches (0.4 mm), an outer diameter OD of about 0.019 inches (0.5 mm), and a length of about 59 inches (1500 mm). The inner diameter ID of inner liner 14 provides clearance for a standard 0.014 inch guidewire 26. Outer diameter OD of inner sleeve 14 provides clearance for outer layer 12 and tissue-removing element 20. Having a space between inner liner 14 and outer layer 12 reduces friction between the two components and allows saline between the components to be poured.

In the illustrated embodiment, marker bands 66 are disposed on the outer surface of the distal end of inner liner 14. Marker band 66 configures the tip of inner liner 14 to be visible under fluoroscopy, which allows the physician to verify the position of the liner during a medical procedure. In this embodiment, the distal end of inner liner 14 may be laser cut to provide a low profile tip. In one embodiment, marker band 66 comprises a platinum iridium strip.

It is also contemplated that the distal end of inner liner 14 may have other configurations without departing from the scope of the present disclosure. For example, atraumatic tip 68 may be attached to the distal end of inner sleeve 14 (fig. 7). Atraumatic tip 68 provides a soft, low profile distal end to facilitate delivery of inner liner 14 through a body lumen without causing trauma. The atraumatic tip 68 may have a maximum outer diameter of about 0.02 inches (0.6 millimeters). Other sizes of atraumatic tips are also contemplated. In another embodiment, tapered tip 70 may be attached to the distal end of inner liner 14 (FIG. 8). Tapered tip 70 may be formed from a layer of material configured to protect the distal end of inner liner 14.

Referring to fig. 1, 2 and 9, tissue-removing element 20 extends along longitudinal axis LA from a proximal end adjacent the distal portion of outer layer 12 to an opposite distal end. Tissue-removing element 20 is operatively connected to motor 43 for rotation by the motor. When the catheter 10 is inserted into a body lumen and the motor 43 rotates the tissue-removing element 20, the tissue-removing element is configured to remove occluded tissue in the body lumen to separate the tissue from the body lumen wall. In one or more embodiments, any suitable tissue-removing element for removing tissue in a body lumen as the body lumen is rotated can be used. In one embodiment, the tissue removal element 20 comprises an abrading rasp configured to abrade tissue in a body cavity as the motor 43 rotates the abrading rasp. The grinding rasp 20 may have a ground outer surface formed, for example, by diamond grit coating, surface etching, or the like. In one embodiment, the tissue-removing element comprises a stainless steel sphere, the outer surface of which comprises 5 microns of exposed diamond crystals. The tissue-removing element 20 may also be radiopaque to allow the tissue-removing element to be visible under fluoroscopy. In other embodiments, the tissue-removing elements may include one or more cutting elements having smooth or serrated cutting edges, macerators, thrombectomy lines, or the like.

cavity 72 extends longitudinally through tissue-removing element 20 such that the tissue-removing element defines openings at its proximal and distal ends. The cavity 72 receives a portion of the outer layer 12 for mounting the tissue-removing element 20 to the outer layer. The cavity 72 includes a first diameter portion 74 extending from the proximal end of the tissue removal element 20, a tapered diameter portion 76 extending from the first diameter portion toward the distal end of the tissue removal element, and a second diameter portion 78 extending from the tapered diameter portion to the distal end of the tissue removal element. The diameters of the first diameter portion 74 and the second diameter portion 78 are constant along their lengths. In the illustrated embodiment, the diameter D1 of the first diameter portion 74 is greater than the diameter D2 of the second diameter portion 78. In one embodiment, the diameter D1 of the first diameter portion 74 is approximately 0.035 inches (0.9 millimeters) and the diameter D2 of the second diameter portion 78 is approximately 0.022 inches (0.56 millimeters). The tapered diameter portion 76 provides a transition between the first diameter portion 74 and the second diameter portion 78. The outer layer 12 is received in the first diameter portion 74 and the distal end of the outer layer abuts the tapered diameter portion 76. Tissue-removing element 20 may be fixedly attached to the distal end of outer layer 12 by any suitable means. In one embodiment, an adhesive bonds tissue-removing element 20 to outer layer 12. Inner sleeve 14 extends through outer layer 12 and second diameter portion 78 of tissue-removing element 20. Second diameter portion 78 is sized to allow inner liner 14 to pass therethrough with a small clearance. Inner diameter D2 provides clearance between tissue-removing element 20 and inner sleeve 14 to reduce friction between the components and allow space for saline perfusion. Thus, the tissue-removing elements 20 are shaped and arranged to extend around at least a portion of the inner and outer liners 14, 12 and thus provide a relatively compact assembly for abrading tissue at the distal portion of the catheter 10.

The outer surface of tissue-removing element 20 includes a proximal section 80, an intermediate section 82, and a distal section 84. The diameter of proximal section 80 increases from the proximal end of tissue-removing element 20 to intermediate section 82. The intermediate section has a constant diameter and extends from the proximal section 80 to the distal section 84. The diameter of distal section 84 tapers from intermediate section 82 to the distal end of tissue-removing element 20. The tapered distal section 84 provides the tissue-removing element 20 with a generally wedge-like shape to wedge the narrowed tissue channel open as it simultaneously clears the channel by removing tissue using the abrasive action of the tissue-removing element. The distal end of tissue-removing element 20 is also rounded to provide a blunt distal end for the tissue-removing element.

Referring to fig. 1 and 2, to remove tissue in a body lumen of a subject, a physician inserts a guidewire 26 into the body lumen of the subject to a location distal to the tissue to be removed. The physician then inserts the proximal portion of guidewire 26 through guidewire lumen 24 of inner sleeve 14 and through handle 40 such that the guidewire extends through proximal port 47 in the handle. Inner liner 14 may also extend through handle 40 and out proximal port 47. With the catheter 10 loaded onto the guidewire 26, the physician advances the catheter along the guidewire until the tissue-removing element 20 is positioned proximal to and adjacent to the tissue. When tissue-removing element 20 is positioned proximal to and adjacent to tissue, the physician uses actuator 42 to actuate motor 43 to rotate outer layer 12 and the tissue-removing element mounted thereon. As the tissue-removing element is rotated, tissue-removing element 20 abrades (or otherwise removes) tissue in the body lumen. While tissue-removing element 20 is rotated, the physician may selectively move outer layer 12 and inner liner 14 distally along guidewire 26 to abrade tissue and, for example, increase the size of the passage through the body lumen. The physician may also move outer layer 12 and inner sleeve 14 proximally along guidewire 26, and may repeatedly move the components in the distal and proximal directions to achieve a back and forth movement of tissue-removing element 20 across the tissue. During the milling process, inner liner 14 isolates guidewire 26 from rotating outer layer 12 and tissue-removing element 20 to protect the guidewire from damage by rotating components. Thus, inner sleeve 14 is configured to withstand the twisting and frictional effects of rotating outer layer 12 and tissue-removing element 20 without transferring those effects to guidewire 26. When the physician is finished using the catheter 10, the catheter can be withdrawn from the body cavity and detached from the guidewire 26 by sliding the catheter proximally along the guidewire. The guidewire 26 used for the milling procedure may remain in the body lumen for subsequent procedures.

When introducing elements of the present invention or one or more embodiments thereof, the articles "a," "an," "the," and "said" are intended to mean that there are one or more of the elements. The terms "comprising," "including," and "having" are intended to be inclusive and mean that there may be additional elements other than the listed elements.

As various changes could be made in the above devices, systems, and methods without departing from the scope of the invention, it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.