WITH A CONTROLLABLE SHEATH

The disclosure of U.S. Patent Application Ser. No. 15/425,321, to which this application claims priority, is incorporated herein by reference.

TECHNICAL FIELD

[0001] This document relates generally to the art of endovascular procedures and, more particularly, to an endovascular catheter using mechanical or vibrational energy to perform a medical procedure, such as an atherectomy or crossing an occlusion, with enhanced directional control of the energy delivery, such as by using a controllable sheath.

BACKGROUND

[0002] Ultrasonic catheters have been proposed. An example of such a catheter is shown in U.S. Patent No. 7,540,852, the disclosure of which is fully incorporated herein by reference. While this catheter achieves the desired result of providing enhanced disruption of blood vessel obstructions, the present disclosure proposes certain modifications or improvements to enhance the results achieved during an endovascular procedure in terms of clearing an obstruction from a vessel (such as, for example, an atherectomy for removing atherosclerosis from a blood vessel, or for crossing an occlusion).

SUMMARY

[0003] An object of the disclosure is to provide a medical apparatus that can selectively direct the delivery of mechanical or vibrational (e.g., ultrasonic) energy in a radial direction from a wave guide. The apparatus may be considered in general terms to provide a director for selectively directing the delivery of the ultrasonic energy from the wave guide. The director may be in the form of a first sheath, which may have a window for exposing a portion of the wave guide for delivering ultrasonic energy in the radial direction while blocking delivery of ultrasonic energy from other portions of the wave guide. An optional second sheath may also be provided for selectively covering the window. The director or sheaths may be rotatable relative to the wave guide (and each other, as applicable).

[0004] According to a first aspect of the disclosure, a medical apparatus is provided, such as for possible use in performing an endovascular procedure using ultrasonic energy. The apparatus comprises a catheter including a proximal end portion and a distal end portion having a first window, which may be elongated in a longitudinal direction of the catheter. A wave guide is provided for delivering the ultrasonic energy for performing the endovascular procedure. A cover is also provided for selectively covering the window.

[0005] In one embodiment, the distal end portion of the catheter includes an opening through which the wave guide may pass. The catheter may comprise a first sheath including the first window. The cover may comprise a rotatable second sheath for covering the first window of the first sheath. The second sheath may include a second window for aligning with the first window, as well as an opening through which the wave guide may pass.

[0006] According to a further aspect of the disclosure, a medical apparatus is provided, such as for performing an endovascular procedure. The apparatus includes a source of energy, and a wave guide for delivering the energy for performing the endovascular procedure. A catheter is provided for receiving the wave guide. The catheter includes a first window for transmitting ultrasonic energy from the wave guide and an opening at a distal end through which the wave guide may pass.

[0007] In one embodiment, a cover is provided for selectively covering the first window, which may be elongated in a longitudinal direction of the catheter. The catheter may comprise a first sheath including the window, and the cover may comprise a rotatable second sheath for covering the window of the first sheath. The second sheath may include a second window for aligning with the window of the first sheath. The second sheath may further include an opening through which the wave guide may pass.

[0008] Still a further aspect of the disclosure pertains to a medical apparatus, such as for performing an endovascular procedure using ultrasonic energy. The apparatus comprises a wave guide for delivering the ultrasonic energy for performing the endovascular procedure. A catheter is adapted for selectively blocking or transmitting the ultrasonic energy from the wave guide.

[0009] In one embodiment, the catheter comprises a first window for exposing a portion of the wave guide. A cover is also provided for covering the first window. The catheter may comprise a first sheath including the first window and a second sheath forming the cover. The second sheath may also comprise a second window corresponding to the first window. One or both of the first and second sheaths may be rotatably mounted to the catheter. A source connected to the catheter may supply energy to the wave guide.

[0010] Still further, the disclosure proposes a medical apparatus for supplying ultrasonic energy from a wave guide. The apparatus comprises a first sheath including a first window, and a rotatable second sheath for covering the first window of the first sheath. The second sheath includes a second window for aligning with the first window and the first and second sheaths each include an opening through which the wave guide may pass.

[0011] This disclosure also pertains to a method of providing a catheter including a proximal end portion and a distal end portion, the distal end portion having a first window associated with a wave guide for delivering ultrasonic energy. The method includes providing a cover for selectively blocking the release of ultrasonic energy from the wave guide, such as by covering the first window. The providing step may involve providing a second sheath having a second window corresponding to the first window. The providing step may further comprise rotatably mounting the first and second sheaths to the catheter. The method may further include the step of extending the wave guide through an opening in the distal end of the catheter (which may be formed by the concentric ends of the first and second sheaths).

BRIEF DESCRIPTION OF THE DRAWING FIGURES

[0012] The accompanying drawing figures incorporated herein and forming a part of the specification, illustrate several aspects of the ultrasonic endovascular catheter with a controllable sheath and, together with the description, serve to explain certain principles thereof. In the drawing figures: [0013] Figure 1 is a schematic view of a prior art catheter system including a vibrational catheter;

[0014] Figure 2 is a side view illustrating a general layout of a prior art catheter;

[0015] Figure 3 is a partially cross-sectional, partially cutaway view of a catheter including a wave guide;

[0016] Figure 4 is a side view of a catheter with a controllable sheath according to one aspect of the disclosure;

[0017] Figure 5 is a close-up view of the distal end portion of the catheter of Figure 4; and

[0018] Figures 6 and 7 illustrate an alternate embodiment.

[0019] Reference will now be made in detail to the presently disclosed embodiments of the inventive aspects of the ultrasonic endovascular catheter with a controllable sheath, examples of which are illustrated in the accompanying drawing figures.

DETAILED DESCRIPTION

[0020] Catheters for supplying energy from a remote source provide for disruption of occlusions in blood vessels, such as for example, plaques, clots, lesions, or like objects that hinder blood flow. Catheters generally include a catheter body (shaft), an energy transmission member, such as a wave guide, disposed within the catheter body and a distal head coupled with the energy transmission member and disposed at or near the distal end of the catheter body. The wave guide transmits energy from a transducer to the distal end of the catheter, causing it to vibrate and, thus, disrupt, dissolve, or debulk vascular occlusions (which procedures are generally called atherectomies or thrombectomies). A number of improved features of such a catheter are outlined more fully in the following description.

[0021] Referring now to Figure 1, one embodiment of a catheter system 20 includes a vibrational (ultrasound or ultrasonic) catheter 10 and an energy source 16 for delivering mechanical or vibrational energy (which may comprise an ultrasonic generator). Catheter 10 includes a distal end 26 for disrupting occlusions, a catheter shaft or body 27, and a proximal connector 12 for coupling catheter 10 with an ultrasonic transducer 14. Ultrasonic transducer 14 is coupled with source 16 via a connector 28, and generator is coupled with a control, such as a foot-actuated on/off switch 18 via another connector 29. Source 16 provides energy to transducer 14 and, thus, to ultrasonic catheter 10.

[0022] Catheter 10 further includes an ultrasonic wave guide (or "core wire"— not shown in Figure 1) that extends through the catheter body 27 and transmits energy from the transducer 14 to the distal end 26. Some embodiments of catheter 10 include a guidewire, which in Figure 1 is shown as a so-called "rapid exchange" guidewire 13 and guidewire port, while other embodiments include a proximal guidewire port for over the wire guidewire delivery. In some embodiments, transducer 14 further includes a coupler 15 for coupling the catheter 10 to transducer 14. Connectors 28, 29 may comprise an electric cord or cable or any other suitable connecting devices for coupling on/off switch 18, source 16 and transducer 14. In an alternative embodiment, on/off switch 18 is located on source 16.

[0023] In addition to proximal connector 12, ultrasonic catheter 10 may include one or more other various components, such as a Y-connector 11 including a fluid inlet port 17 (or aperture) for passage of irrigation fluid. Inlet port 17 may be removably coupled with an irrigation tube 24, which in one embodiment may be coupled with a fluid refrigerator 30. The refrigerator 30 may, in turn, be coupled with a fluid container 32 via a connector tube 34. This arrangement may be used for introducing one or more fluids into catheter 10. Fluid may be used to cool any part of the device, such as the ultrasonic wave guide, thus helping reduce wear and tear on the catheter 10. In some embodiments, fluid inlet port 17 is located farther proximally on proximal connector 12, to allow fluid to be applied within connector 12. In some embodiments, refrigerated fluid is used, while in other embodiments irrigation fluid may be kept at room temperature. In various embodiments, oxygen supersaturated fluid, lubricious fluid, or any other suitable fluid or combination of fluids may be used, and again, such fluids may be refrigerated or kept room temperature. In an alternative embodiment to that shown in Figure 1, refrigerator 30 and fluid container 32 are combined in one unit. [0024] Generally, catheter 10 may include any suitable number of side-arms or ports for passage of a guidewire, application of suction, infusing and/or withdrawing irrigation fluid, dye and/or the like, or any other suitable ports or connections. Also, ultrasonic catheters 10 per the disclosure may be used with any suitable proximal devices, such as any suitable ultrasonic transducer 14, energy source 16, coupling device(s) and/or the like. Therefore, the exemplary embodiment shown in Figure 1 and any following descriptions of proximal apparatus or systems for use with ultrasonic catheters 10 should not be interpreted to limit the scope of the appended claims.

[0025] Referring now to Figure 2, an enlarged view of catheter 10 is shown. Proximal connector 12, Y-connector 11, inlet port 17, catheter body 27, distal end 26 and guidewire 13 are all shown. Catheter body 27 is generally a flexible, tubular, elongate member, having any suitable diameter and length for reaching a vascular occlusion for treatment. In one embodiment, for example, catheter body 27 preferably has an outer diameter of between about 0.5 mm and about 5.0 mm. In other embodiments, as in catheters intended for use in relatively small vessels, catheter body 27 may have an outer diameter of between about 0.25 mm and about 2.5 mm. Catheter body 27 may also have any suitable length. As discussed briefly above, for example, some ultrasonic catheters have a length in the range of about 150 cm. However, any other suitable length may be used without departing from the scope of the present disclosure.

[0026] Referring now to Figure 3, a proximal portion of one embodiment of an ultrasonic catheter 110 is shown in cross-section. An ultrasonic wave guide 140 extends from a sonic connector 152 distally to a distal end (not shown) of catheter 110. A catheter body 127 of catheter 110 is shown only in part in this Figure, whereas catheter body may extend distally to (or near) the distal end of catheter 110, as shown in Figure 4, with the wave guide 140 also extending a particularly long distance (e.g., 30 centimeters or greater, and typically between about 15 centimeters and 30 centimeters). The catheter body 127 may be a constant diameter, or may have a variable diameter from the proximal to the distal end (such as, for example, wider in diameter at the proximal end near the point of entering the vasculature than at the distal end).

[0027] Catheter 110 also includes a proximal housing 112 (or "proximal connector"), having an inner bore 144 (or "inner cavity") in which sonic connector 152, a portion of ultrasonic wave guide 140 and one or more vibration absorbers 150 reside. Housing 112 is coupled with a Y-connector 111, which includes a fluid inlet port 117 (or aperture), and Y- connector 111 is coupled with catheter body 127.

[0028] In various embodiments, housing 112 may suitably include one or more surface features 142 for increasing the overall surface area of the outer surface of housing 112. Increased surface area enhances the ability of housing 112 to dissipate heat generated by ultrasonic wave guide 140 out of catheter 110. Surface features 142 may have any suitable size or shape, such as ridges, jags, undulations, grooves or the like, and any suitable number of surface features 142 may be used. Additionally, housing 112 may be made of one or more heat dissipating materials, such as aluminum, stainless steel, any other conductive metal(s), or any suitable non-metallic conductive material(s).

[0029] In most embodiments, ultrasonic wave guide 140, such as wire, extends longitudinally through a lumen of catheter body 127 to transmit ultrasonic energy from an ultrasonic transducer 14 (not shown in Figures 2 and 3), connected to the proximal end of proximal housing 112, to the distal end of catheter 110. Wave guide 140 may be formed of any material capable of effectively transmitting ultrasonic energy from the ultrasonic transducer 14 to the distal end of catheter body 127, including but not limited to metals such as pure titanium or aluminum, titanium or aluminum alloys, or shape memory materials (such as nitinol), and may be coated (such as using a polymeric material). Again, additional details of ultrasonic wave guides 140 may be found in the patent applications incorporated by reference. Similarly, reference may be made to the incorporated references for descriptions of housing 112, sonic connector 152, vibration absorbers 150, Y-connector 111 and the like. For example, housing 112 and other features are described in U.S. Patent No. 7,335,180, the disclosure of which is incorporated herein by reference.

[0030] Ultrasonic wave guide 140 typically passes from a sonic connector 152, through bore 144 and Y-connector 111, and then through catheter body 127. Fluid inlet port 117 is in fluid communication with a lumen in Y-connector, which is in fluid communication with a lumen extending through catheter body 127. Thus, fluid introduced into fluid inlet port 117 is typically free to flow into and through catheter body 127 to contact ultrasonic wave guide 140. Fluid may flow out of catheter body 127 through apertures in the distal head (not shown) or through any other suitable apertures or openings, such as apertures located in catheter body 127 itself. Any suitable fluid may be passed through fluid inlet port 117 and catheter body 127, such as refrigerated fluid, lubricious fluid, super- saturated saline or contrast/saline mixture, or the like. Cooling and/or lubricating ultrasonic wave guide 140 may reduce friction and/or wear and tear of ultrasonic wave guide 140, thus prolonging the useful life of ultrasonic catheter 110 and enhancing its performance.

[0031] Referring now to Figure 4, it can be understood that a director may be provide for directing the release of ultrasonic energy in a radial direction. Specifically, the catheter body 127 may take the form of a sheath 127a in which the wave guide 140 is at least partially positioned. The proximal end of the sheath 127a may be positioned adjacent to the housing 112, and may extend within the Y-connector 111, as shown in Figure 3, or may be external to it, as shown in Figure 4. In either case, the sheath 127a may be adapted to rotate relative to the wave guide 140, as indicated by action arrow R. Alternatively, the sheath 127a may be fixed in position relative to the connector 111 or housing 112.

[0032] The sheath 127a may also include a lateral or side opening, such as a window

127b, adjacent to a portion of the wave guide 140, and thus exposing it to the interior of a lumen or vessel when positioned therein. As indicated in Figure 5, the sheath 127a may be rotated relative to the wave guide 140, thus serving as a director. Specifically, the direction of the ultrasonic energy is controlled by the position of the window 127b (note action arrows E) or, alternatively, the entire catheter 110 may be rotated if the sheath is fixed. In either case, by selectively controlling the position of the window 127b through rotation, a focused or targeted treatment may be provided for a particular area of the vessel in which the catheter 110 is at least partially positioned, since only a portion of the wave guide 140 is exposed to the opening thus formed.

[0033] To allow for an enhanced level of control by controlling the direction of the ultrasonic energy, the window 127b may also be selectively blocked. In one example, this may be achieved by providing a cover 128 for selectively covering the opening or window 127b in the sheath 127a. As indicated in Figures 6 and 7, the cover 128 in one particular version may comprise a second sheath 128a over the first sheath 127a, such that the two structures are generally concentric relative to each other and about source of ultrasonic energy, such as the wave guide 140. This second sheath 127a may also extend to the proximal end of the catheter 110, such as adjacent to or within the connector 111, and may include an open end 128c. The second sheath 128a may further include a lateral or side opening, such as a window 128b, which may have a size and shape matching or corresponding to window 127b in the first sheath 127a.

[0034] Thus, as indicated in Figure 6, the second sheath 128a may be rotated relative to the first sheath 127a (which may be fixed or stationary, or also rotatable as noted above) such that the window 127b is covered by a portion of the second sheath. In this manner, the energy may be directed to wave guide 140 through the open end 127c of the sheaths 127a, 128a, and the catheter 110 may be used in crossing a chronic total occlusion (CTO) in this configuration.

[0035] When it is desired to allow for ultrasonic energy to be transmitted radially of the longitudinal axis of the catheter 110, the second sheath 128a may be rotated to align the windows 127b, 128b. This allows the energy (arrow E) to pass into the vessel through the opening thus formed, as shown in Figure 7. The relative rotation may also be achieved such that the opening only partially exposes the wave guide 140, which may provide for a further level of control.

[0036] Control of the relative rotation may be achieved at the proximal end of the catheter by providing suitable markings on the sheaths 127a, 128a to indicate the aligned position of the openings or windows 127b, 128b. The markings may be in the form of printed indicia, but may also take the form of bosses or embosses (and may be arranged to interact to create a temporary locked condition). Alternatively, radiographic visualization may be used, such as by providing one or more radiopaque markers on the periphery of the windows 127b, 128b. Alignment of the markers under fluoroscopy may indicate the aligned position of the windows.

[0037] In summary, an improved ultrasonic catheter 110 includes directional capabilities for selectively controlling the output of energy in a radial direction. In the illustrated embodiment, a controllable sheath 127a or 128a (or both) is provided. One or both of the sheaths 127a, 128a may include a window 127b, 128b and may be adapted for relative rotation. By aligning the windows 127b, 128b to form an opening, the transmission of energy from a wave guide 140 associated with the catheter 110 may result. Yet, the catheter 110 may also be used in a "crossing" mode, such as for crossing a CTO, by reorienting the sheaths 127a, 128a and thus closing the opening formed by the windows 127b, 128b and regulating the transmission of ultrasonic energy.

[0038] This disclosure may be considered to disclose the following items:

[0039] 1. A medical apparatus for supplying ultrasonic energy, comprising: a catheter including a proximal end portion and a distal end portion, the distal end portion having a first window; a wave guide for delivering the ultrasonic energy for performing the endovascular procedure; and a cover for selectively covering the first window.

[0040] 2. The apparatus of item 1, wherein the distal end portion of the catheter includes an opening through which the wave guide may pass.

[0041] 3. The apparatus of item 1 or item 2, wherein the catheter comprises a first sheath including the window, and the cover comprises a rotatable second sheath for covering the first window of the first sheath.

[0042] 4. The apparatus of any of items 1-3, wherein the second sheath includes a second window for aligning with the first window.

[0043] 5. The apparatus of any of items 1-4, wherein the second sheath includes an opening through which the wave guide may pass.

[0044] 6. The apparatus of any of items 1-5, wherein the first window is elongated in a longitudinal direction of the catheter.

[0045] 7. A medical apparatus, comprising: a source of ultrasonic energy; a wave guide for delivering the ultrasonic energy for performing the endovascular procedure; and a catheter for receiving the wave guide, the catheter including a first window for transmitting ultrasonic energy from the wave guide and further including an opening at a distal end through which the wave guide may pass.

[0046] 8. The apparatus of item 7, further including a cover for selectively covering the first window.

[0047] 9. The apparatus of item 7 or item 8, wherein the catheter comprises a first sheath including the first window, and the cover comprises a movable second sheath for selectively blocking or covering the first window of the first sheath.

[0048] 10. The apparatus of any of items 7-9, wherein the second sheath includes a second window for aligning with the first window of the first sheath.

[0049] 11. The apparatus of any of items 7-10, wherein the second sheath includes an opening through which the wave guide may pass.

[0050] 12. The apparatus of any of items 7-11, wherein the window is elongated in a longitudinal direction of the catheter.

[0051] 13. A medical apparatus for providing ultrasonic energy, comprising: a wave guide for delivering the ultrasonic energy for performing the endovascular procedure, the wave guide including a distal end; and a catheter at least partially covering the wave guide and adapted for selectively blocking or transmitting the ultrasonic energy by exposing a portion of the wave guide proximal of a distal end of the catheter.

[0052] 14. The apparatus of item 13, wherein the catheter comprises a first window for exposing the portion of the wave guide. [0053] 15. The apparatus of item 13 or item 14, further including a cover for covering the first window.

[0054] 16. The apparatus of any of items 13-15, wherein the catheter comprises a first sheath including the first window and a second sheath forming the cover.

[0055] 17. The apparatus of any of items 13-16, wherein the second sheath comprises a second window corresponding to the first window.

[0056] 18. The apparatus of any of items 13-17, wherein the first sheath is rotatably mounted to the catheter.

[0057] 19. The apparatus of any of items 13-18, wherein the second sheath is rotatably mounted to the catheter.

[0058] 20. The apparatus of any of items 1-19, further including a source connected to the catheter for supplying ultrasonic energy to the wave guide.

[0059] 21. A medical apparatus for supplying ultrasonic energy from a wave guide, comprising: a first sheath including a first window; a rotatable second sheath for covering the first window of the first sheath; wherein the second sheath includes a second window for aligning with the first window, and the first and second sheaths each include an opening through which the wave guide may pass in a travel direction, such as for crossing a lesion with the first and second sheaths arranged to close the path for delivering ultrasonic energy formed by the first and second windows when aligned.

[0060] 21a. The apparatus of item 21, in combination with any of the features of items

1-20, considered together or alone. [0061] 22. A method of providing a catheter including a proximal end portion and a distal end portion, the distal end portion having a first window associated with a wave guide for delivering ultrasonic energy comprising; providing a cover for selectively covering the first window.

[0062] 23. The method of item 22, wherein the providing step comprises providing a second sheath having a second window corresponding to the first window.

[0063] 24. The method of item 22 or item 23, wherein the providing step comprises rotatably mounting the first and second sheaths to the catheter.

[0064] 25. The method of any of items 22-24, further including the step of extending the wave guide through an opening in the distal end of the catheter.

[0065] 26. A medical apparatus comprising: a wave guide for delivering ultrasonic energy in a radial direction; and a director for selectively directing the delivery of the ultrasonic energy from the wave guide.

[0066] 27. The medical apparatus of item 26, wherein the director comprises a first sheath.

[0067] 28. The medical apparatus of item 27, wherein the first sheath comprises a window for exposing a portion of the wave guide for delivering ultrasonic energy in the radial direction while blocking delivery of ultrasonic energy from other portions of the wave guide.

[0068] 29. The medical apparatus of item 28, further including a second sheath for selectively covering the window.

[0069] 30. The medical apparatus of item 26, wherein the director is rotatable relative to the wave guide. [0070] 31. The medical apparatus of any of items 26-31, wherein the director includes an opening for allowing the wave guide to advance in a travel direction, such as for crossing a lesion.

[0071] 32. A pair of concentric sheaths for forming a medical apparatus, each having windows that align for releasing ultrasonic energy from a source at least partially covered by the sheaths.

[0072] The foregoing description has been presented for purposes of illustration. It is not intended to be exhaustive or to limit the embodiments to the precise form disclosed. Obvious modifications and variations are possible in light of the above teachings. For instance, instead of rotatable sheaths 127a, 128a, one or both of the sheaths may be made to telescope relative to each other to selectively uncover or block the opening for transmitting energy radially from the wave guide 140. The size and shape of the opening formed by the window 127b or 128b may also be altered from what is shown in the drawings to suit a particular desire or need in terms of a treatment regimen. All modifications and variations are within the scope of the appended claims when interpreted in accordance with the breadth to which they are fairly, legally and equitably entitled.