阅读说明：本技术 组织移除导管 (tissue removal catheter ) 是由 A·詹莫斯 J·凯利 C·麦克马伦 M·弗莱明 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(10)包括细长主体(12)。组织移除元件(20)安装在细长主体(12)的远端部分(18)上。该组织移除元件(20)包括主体,该主体包括外表面,该外表面具有从组织移除元件(20)的近端朝向远端延伸的第一部段(80)。第二部段(82)从第一部段(80)朝向组织移除元件(20)的远端延伸。第三部段(84)从第二部段(84)延伸至组织移除元件(20)的远端。在第一部段(80)与第二部段(82)之间的过渡部限定有第一角度(α),该第一角度形成在第一部段(80)与第二部段(82)之间。在第二部段(82)与第三部段(84)之间的过渡部限定有第二角度(β),该第二角度在第二部段(82)与第三部段(84)之间形成。组织移除元件(20)构造成随着该组织移除元件(20)在体腔内由细长主体(12)旋转而移除组织。(A tissue-removing catheter (10) for removing tissue in a body lumen includes an elongate body (12). A tissue-removing element (20) is mounted on the distal end portion (18) of the elongate body (12). The tissue-removing element (20) includes a body including an outer surface having a first section (80) extending from a proximal end toward a distal end of the tissue-removing element (20). The second section (82) extends from the first section (80) towards the distal end of the tissue-removing element (20). The third section (84) extends from the second section (84) to the distal end of the tissue-removing element (20). A first angle (alpha) is defined at a transition between the first section (80) and the second section (82), the first angle being formed between the first section (80) and the second section (82). A second angle (beta) is defined at the transition between the second section (82) and the third section (84), said second angle being formed between the second section (82) and the third section (84). The tissue-removing element (20) is configured to remove tissue as the tissue-removing element (20) is rotated within the body lumen by the elongate body (12).)

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; and

A tissue-removing element mounted on the distal end portion of the elongate body, the tissue-removing element comprising a body including an outer surface having a first section extending from a proximal end of the tissue-removing element toward a distal end, a second section extending from the first section toward the distal end of the tissue-removing element, and a third section extending from the second section to the distal end of the tissue-removing element, a transition between the first section and the second section defining a first angle formed between the first section and the second section, and a transition between the second section and the third section defining a second angle formed between the second section and the third section, the tissue-removing element configured, removing the tissue as the tissue-removing element is rotated within the body lumen by the elongate body.

2. The tissue-removing catheter set forth in claim 1, wherein the tissue-removing element has a longitudinal axis, the first section having a cross-sectional dimension extending perpendicular to the longitudinal axis of the tissue-removing element, the cross-sectional dimension increasing from the proximal end of the tissue-removing element to the second section.

3. The tissue-removing catheter set forth in claim 2, wherein the second section has a cross-sectional dimension extending perpendicular to the longitudinal axis of the tissue-removing element, the cross-sectional dimension of the second section remaining constant from the first section to the third section.

4. The tissue-removing catheter set forth in claim 3, wherein the third section has a cross-sectional dimension extending perpendicular to the longitudinal axis of the tissue-removing element, the cross-sectional dimension of the third section decreasing from the second section to the distal end of the tissue-removing element.

5. The tissue-removing catheter set forth in claim 1, further comprising a cavity extending through the body of the tissue-removing element from the proximal end to the distal end.

6. The tissue-removing catheter set forth in claim 5, wherein the cavity comprises a first section extending distally from the proximal end of the tissue-removing element and a second section extending proximally from the distal end of the tissue-removing element, the first section having a cross-sectional dimension greater than a cross-sectional dimension of the second section.

7. the tissue-removing catheter set forth in claim 6, wherein the cavity comprises a third section extending from the first section to the second section, the third section having a decreasing cross-sectional dimension from the first section to the second section.

8. the tissue-removing catheter set forth in claim 6, wherein the cross-sectional dimension of the first section is about 0.035 inches (0.9 mm).

9. the tissue-removing catheter set forth in claim 6, wherein the cross-sectional dimension of the second section is about 0.022 inches (0.56 millimeters).

10. The tissue-removing catheter set forth in claim 1, wherein the distal end of the tissue-removing element is blunt.

11. the tissue-removing catheter set forth in claim 1, wherein the body of the tissue-removing element comprises one of stainless steel, titanium, brass, and ceramic.

12. The tissue-removing catheter set forth in claim 11, wherein the outer surface of the body comprises a diamond grit coating.

13. The tissue-removing catheter set forth in claim 12, wherein the diamond grit coating comprises between about 2 and about 50 microns of exposed diamond crystals.

14. The tissue-removing catheter set forth in claim 1, wherein the tissue-removing element is radiopaque, thereby configuring the tissue-removing element to be visible under fluoroscopy.

15. A tissue-removing element for use with a tissue-removing catheter for removing tissue in a body lumen, the tissue-removing element comprising a body including an outer surface having a first section extending from a proximal end towards a distal end of the tissue-removing element, a second section extending from the first section towards the distal end of the tissue-removing element, and a third section extending from the second section to the distal end of the tissue-removing element, a transition between the first section and the second section defining a first angle formed between the first section and the second section, and a transition between the second section and the third section defining a second angle formed between the second section and the third section, the tissue-removing element is configured to remove the tissue as the tissue-removing element is rotated within the body lumen by the tissue-removing catheter.

16. the tissue-removing element of claim 15, wherein the tissue-removing element has a longitudinal axis, the first section having a cross-sectional dimension extending perpendicular to the longitudinal axis of the tissue-removing element, the cross-sectional dimension increasing from the proximal end of the tissue-removing element to the second section.

17. The tissue-removing element of claim 15, wherein the second section has a cross-sectional dimension extending perpendicular to the longitudinal axis of the tissue-removing element, the cross-sectional dimension of the second section remaining constant from the first section to the third section.

18. The tissue-removing element of claim 15, wherein the third section has a cross-sectional dimension extending perpendicular to the longitudinal axis of the tissue-removing element, the cross-sectional dimension of the third section decreasing from the second section to the distal end of the tissue-removing element.

19. The tissue-removing element of claim 15, further comprising a cavity extending through the body of the tissue-removing element from the proximal end to the distal end, wherein the cavity comprises a first section extending distally from the proximal end of the tissue-removing element, a second section extending proximally from the distal end of the tissue-removing element, and a third section extending from the first section to the second section, the first section having a cross-sectional dimension that is greater than a cross-sectional dimension of the second section, and the third section having a cross-sectional dimension that decreases from the first section to the second section.

20. The tissue-removing element of claim 15, wherein the distal end of the tissue-removing element is blunt.

Technical Field

The present disclosure relates generally to a tissue-removing catheter, and more particularly to a tissue-removing element for a tissue-removing catheter.

Background

Tissue removal catheters are used to remove unwanted tissue in a body cavity. As an example, rotational atherectomy catheters are used to remove material from a blood vessel to open the blood vessel and improve blood flow through the blood vessel. The procedure may be used to prepare a lesion in a coronary artery of a patient to facilitate Percutaneous Transluminal Coronary Angioplasty (PTCA) or stent delivery in a patient with a heavily calcified coronary lesion. Atherectomy catheters typically employ a rotating element that is used to abrade or otherwise destroy unwanted tissue.

Disclosure of Invention

In one aspect, a tissue removal catheter for removing tissue in a body lumen generally includes an elongate body having an axis and proximal and distal portions spaced apart from one another along the axis. The elongated body is sized and shaped to be received in a body lumen. A tissue-removing element is mounted on the distal portion of the elongate body. The tissue-removing element includes a body including an outer surface having a first section extending from a proximal end of the tissue-removing element toward a distal end, a second section extending from the first section toward the distal end of the tissue-removing element, and a third section extending from the second section to the distal end of the tissue-removing element. A transition between the first segment and the second segment defines a first angle formed between the first segment and the second segment. A transition between the second section and the third section defines a second angle formed between the second section and the third section. The tissue-removing element is configured to remove tissue as the tissue-removing element is rotated by the elongate body within the body lumen.

In another aspect, a tissue-removing element for use with a tissue-removing catheter for removing tissue in a body lumen generally includes a body including an outer surface having a first section extending from a proximal end toward a distal end of the tissue-removing element. The second section extends from the first section toward the distal end of the tissue-removing element. The third section extends from the second section to the distal end of the tissue-removing element. A transition between the first segment and the second segment defines a first angle formed between the first segment and the second segment. A transition between the second section and the third section defines a second angle formed between the second section and the third section. The tissue-removing element is configured to remove tissue as the tissue-removing element is rotated within the body lumen by the tissue-removing catheter.

Drawings

Fig. 1 is a front view of a catheter of the present disclosure;

FIG. 2 is an enlarged front view of the distal portion of the catheter;

FIG. 3 is an enlarged front view of the proximal portion of the catheter;

FIG. 4 is an enlarged, fragmentary, longitudinal cross-sectional view of the distal portion of the catheter of FIG. 2;

FIG. 5 is a cross-sectional view taken through line 5-5 of FIG. 2;

FIG. 6 is a partial front view of an insulation bushing of a catheter with portions broken away to show internal detail;

FIG. 7 is an enlarged elevation view of the distal portion of the catheter showing the atraumatic tip on the inner liner;

FIG. 8 is an enlarged elevation view of the distal portion of the catheter showing the tapered tip on the inner liner; and

FIG. 9 is an enlarged longitudinal cross-sectional view of the tissue-removing element of the catheter.

Corresponding reference characters indicate corresponding parts throughout the drawings.

Detailed Description

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., grind, cut, resect, ablate, etc.) occlusive tissue (e.g., embolic tissue, plaque tissue, atherosclerosis, thrombolytic tissue, stenotic tissue, hyperplastic tissue, neoplastic tissue, etc.) from a vessel wall. 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 to maintain 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 occlusive, stenotic or proliferative materials 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 the 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 so that it can be inserted into a body cavity 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 26 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 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 16 of the catheter 10. The 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 (not shown) may be provided on the handle 40 to lock the guidewire 26 in place relative to the handle.

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 (not shown) housed within the handle 40. In other embodiments, the power supply may 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 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 outer layer 12 to be applied to tissue-removing element 20 as catheter 10 traverses a curved 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 is rotated 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 construction. 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 construction,The dual coil layer construction 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, inner liner 14 and outer layer 12 are both 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. In addition, 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 layer 64 of polyimide. The PTFE inner layer 60 provides a lubricious interior to the inner liner 14 that aids in threading the guidewire 26 through the inner liner. 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. Outer polyimide layer 64 provides wear resistance and has lubricity that reduces friction between inner liner 14 and outer layer 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. The space provided between the inner liner 14 and the 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, a tapered tip 70 may be attached to the distal end of inner sleeve 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 includes a body extending from a proximal end adjacent the distal end portion of outer layer 12 to an opposite distal end along longitudinal axis LA 2. 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, tissue-removing element 20 comprises a stainless steel spherical body having an outer surface comprising between about 2 and about 50 microns of exposed diamond crystals. In one embodiment, tissue-removing element 20 comprises about 5 microns of exposed diamond crystals. Tissue-removing element 20 may also be made of titanium, brass, or a ceramic such as zirconia. Other materials are also contemplated. 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.

The cavity 72 extends longitudinally through the body of the tissue removal element 20 such that the tissue removal 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 pass inner liner 14 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 the body 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 transition between the proximal section 80 and the intermediate section 82 forms a first angle a between the proximal section and the intermediate section. In one embodiment, the angle α is less than about 170 degrees. In one embodiment, angle α is about 165 degrees. Similarly, the transition between the intermediate section 82 and the distal section 84 forms a second angle β between the intermediate section and the distal section. In one embodiment, the angle β is less than about 170 degrees. In one embodiment, the angle β is about 165 degrees. Tapered proximal and distal portions 80, 84 provide tissue-removing element 20 with a generally forward and rearward wedge configuration to wedge the narrowed tissue channel open as it simultaneously removes 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.