Steerable Sheath for Intravascular Medical Devices

INVENTORS

William G. Besser, a citizen of United States of America, resident at Minneapolis, MN Preston L. Grothe, a citizen of United States of America, resident at Maple Grove, MN Joseph P. Higgins, a citizen of United States of America, resident at Minnetonka, MN

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Non-Provisional Patent Application No. 16/298003, filed March 11, 2019 and entitled STEERABLE SHEATH FOR

INTRAVASCULAR MEDICAL DEVICES and further claims the benefit of U.S.

Provisional Application No. 62/641,625, filed March 12, 2018 and entitled STEERABLE SHEATH FOR ATHERECTOMY DEVICES AND SYSTEMS, the entirety of which is hereby incorporated by reference.

[0002] STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR

DEVELOPMENT

[0003] Not Applicable

[0004] BACKGROUND OF THE INVENTION

[0005] FIELD OF THE INVENTION

[0006] The disclosure relates to devices and methods using sheaths generally with intravascular medical devices and more specifically with atherectomy devices and systems, including but not limited to orbital atherectomy devices and systems.

[0007] DESCRIPTION OF THE RELATED ART

[0008] It is common to position catheters and/or sheaths to aid in the diagnosis and treatment of various medical disorders such as in the treatment of occlusions, lesions or stenotic material within a blood vessel using, e.g., and without limitation, atherectomy devices and systems including orbital atherectomy devices and systems as well as angioplasty systems. However, there are cases where a strong wire bias exists, such as in regions of vessel curvature, or vessels larger than, e.g., 6 mm. In these cases, the lesion location may not be accessible and, therefore, not treatable using atherectomy and/or angioplasty devices and systems.

[0009] Various embodiments of the present invention address these, inter alia, issues.

[0010] Moreover, we provide disclosure of the following patents and applications, each of which are assigned to Cardiovascular Systems, Inc., and incorporated herein in their entirety, each of which may comprise systems, methods and/or devices that may be used with various embodiments of the presently disclosed subject matter:

[0011] U.S. Pat 6,295,712,“ROTATIONAL ATHERECTOMY DEVICE”;

[0012] U.S. Pat 6,494,890,“ECCENTRIC ROTATIONAL ATHERECTOMY

DEVICE”;

[0013] U.S. Pat 6,132,444,“ECCENTRIC DRIVE SHAFT FOR ATHERECTOMY DEVICE AND METHOD FOR MANUFACTURE”;

[0014] U.S. Pat 6,638,288,“ECCENTRIC DRIVE SHAFT FOR ATHERECTOMY DEVICE AND METHOD FOR MANUFACTURE”;

[0015] U.S. Pat 5,314,438,“ABRASIVE DRIVE SHAFT DEVICE FOR

ROTATIONAL ATHERECTOMY”;

[0016] U.S. Pat 6,217,595,“ROTATIONAL ATHERECTOMY DEVICE”;

[0017] U.S. Pat 5,554,163,“ATHERECTOMY DEVICE”;

[0018] U.S. Pat 7,507,245,“ROTATIONAL ANGIOPLASTY DEVICE WITH

ABRASIVE CROWN”;

[0019] U.S. Pat 6,129,734,“ROTATIONAL ATHERECTOMY DEVICE WITH RADIALLY EXPANDABLE PRIME MOVER COUPLING”;

[0020] U.S. Pat Application 11/761,128,“ECCENTRIC ABRADING HEAD FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES”;

[0021] U.S. Pat Application 11/767,725,“SYSTEM, APPARATUS AND METHOD FOR OPENING AN OCCLUDED LESION”;

[0022] U.S. Pat Application 12/130,083,“ECCENTRIC ABRADING ELEMENT FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES”;

[0023] U.S. Pat Application 12/363,914,“MULTI-MATERIAL ABRADING HEAD FOR ATHERECTOMY DEVICES HAVING LATERALLY DISPLACED CENTER OF MASS”;

[0024] U.S. Pat Application 12/578,222,“ROTATIONAL ATHERECTOMY DEVICE WITH PRE-CURVED DRIVE SHAFT”;

[0025] U.S. Pat Application 12/130,024,“ECCENTRIC ABRADING AND CUTTING HEAD FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES”;

[0026] U.S. Pat Application 12/580,590,“ECCENTRIC ABRADING AND CUTTING HEAD FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES”;

[0027] U.S. Pat Application 29/298,320,“ROTATIONAL ATHERECTOMY

ABRASIVE CROWN”;

[0028] U.S. Pat Application 29/297,122,“ROTATIONAL ATHERECTOMY

ABRASIVE CROWN”;

[0029] U.S. Pat Application 12/466,130,“BIDIRECTIONAL EXPANDABLE HEAD FOR ROTATIONAL ATHERECTOMY DEVICE”;

[0030] U.S. Pat Application 12/388,703,“ROTATIONAL ATHERECTOMY

SEGMENTED ABRADING HEAD AND METHOD TO IMPROVE ABRADING EFFICIENCY”;

[0031] U.S. Pat 9,468,457,“ATHERECTOMY DEVICE WITH ECCENTRIC

CROWN”;

[0032] U.S. Pat 9,439,674,“ROTATIONAL ATHERECTOMY DEVICE WITH

EXCHANGEABLE DRIVE SHAFT AND MESHING GEARS”;

[0033] U.S. Pat 9,220,529,“ROTATIONAL ATHERECTOMY DEVICE WITH

ELECTRIC MOTOR”;

[0034] U.S. Pat 9,119,661,“ROTATIONAL ATHERECTOMY DEVICE WITH

ELECTRIC MOTOR”;

[0035] U.S. Pat 9,119,660,“ROTATIONAL ATHERECTOMY DEVICE WITH

ELECTRIC MOTOR”;

[0036] U.S. Pat 9,078,692,“ROTATIONAL ATHERECTOMY SYSTEM”;

[0037] U.S. Pat 6,295,712,“ROTATIONAL ATHERECTOMY DEVICE”;

[0038] U.S. Pat 6,494,890,“ECCENTRIC ROTATIONAL ATHERECTOMY

DEVICE”; [0039] U.S. Pat 6,132,444,“ECCENTRIC DRIVE SHAFT FOR ATHERECTOMY DEVICE AND METHOD FOR MANUFACTURE”;

[0040] U.S. Pat 6,638,288,“ECCENTRIC DRIVE SHAFT FOR ATHERECTOMY DEVICE AND METHOD FOR MANUFACTURE”;

[0041] U.S. Pat 5,314,438,“ABRASIVE DRIVE SHAFT DEVICE FOR

ROTATIONAL ATHERECTOMY”;

[0042] U.S. Pat 6,217,595,“ROTATIONAL ATHERECTOMY DEVICE”;

[0043] U.S. Pat 5,554,163,“ATHERECTOMY DEVICE”;

[0044] U.S. Pat 7,507,245,“ROTATIONAL ANGIOPLASTY DEVICE WITH

ABRASIVE CROWN”;

[0045] U.S. Pat 6,129,734,“ROTATIONAL ATHERECTOMY DEVICE WITH

RADIALLY EXPANDABLE PRIME MOVER COUPLING”;

[0046] U.S. Pat Application 11/761,128,“ECCENTRIC ABRADING HEAD FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES”;

[0047] U.S. Pat Application 11/767,725,“SYSTEM, APPARATUS AND METHOD FOR OPENING AN OCCLUDED LESION”;

[0048] U.S. Pat Application 12/130,083,“ECCENTRIC ABRADING ELEMENT FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES”;

[0049] U.S. Pat Application 12/363,914,“MULTI-MATERIAL ABRADING HEAD FOR ATHERECTOMY DEVICES HAVING LATERALLY DISPLACED CENTER OF MASS”;

[0050] U.S. Pat Application 12/578,222,“ROTATIONAL ATHERECTOMY DEVICE WITH PRE-CURVED DRIVE SHAFT”;

[0051] U.S. Pat Application 12/130,024,“ECCENTRIC ABRADING AND CUTTING HEAD FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES”;

[0052] U.S. Pat Application 12/580,590,“ECCENTRIC ABRADING AND CUTTING HEAD FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES”;

[0053] U.S. Pat Application 29/298,320,“ROTATIONAL ATHERECTOMY

ABRASIVE CROWN”;

[0054] U.S. Pat Application 29/297,122,“ROTATIONAL ATHERECTOMY

ABRASIVE CROWN”; [0055] U.S. Pat Application 12/466,130,“BIDIRECTIONAL EXPANDABLE HEAD

FOR ROTATIONAL ATHERECTOMY DEVICE”; and

[0056] U.S. Pat Application 12/388,703,“ROTATIONAL ATHERECTOMY

SEGMENTED ABRADING HEAD AND METHOD TO IMPROVE ABRADING

EFFICIENCY”

[0057] U.S. Pat Application 13/681,398,“ROTATIONAL ATHERECTOMY DEVICE WITH A SYSTEM OF ECCENTRIC ABRADING HEADS”; and

[0058] U.S. Pat Application 15/906067,“ECCENTRIC SYSTEM OF ABRASIVE ELEMENTS WITH EQUAL MASS FOR ROTATIONAL ATHERECTOMY

[0059] BRIEF SUMMARY OF THE INVENTION.”

[0060] Various embodiments of a steerable sheath or catheter are disclosed. The sheath or catheter may comprise a preformed curve or angle proximate the distal end of the sheath or catheter and may comprise either an outer straighter or an inner straightener to deform, or control, the degree of curvature. Other embodiments comprise at least two lumens axially along the sheath or catheter wall that are anchored proximate the distal end of the sheath or catheter and extend proximally to the operator, allowing either pushing or pulling control of the region of the sheath or catheter located distal to the anchoring points of the push or pull wires. The push/pull wires may be used to deform, or at least partially straighten, a precurved section of the sheath or catheter or may be use deform, or at least partially curve a straight section of the sheath. In some cases, the curving point may be a weakened portion of the sheath or catheter wall, or may comprise a shape memory material with at least one preset position. Further, the push/pull wires may be configured to transmit heat to a curveable section that is responsive to changes in temperature, thereby enabling curving, or straightening, when activated by heat.

[0061] The figures and the detailed description which follow more particularly exemplify these and other embodiments of the invention.

[0062] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0063] Figure 1A is a cutaway view of a prior art device.

[0064] Figure 1B is a cutaway view of one embodiment of the present invention illustrated as an angled or J-shape activated steerable sheath within a blood vessel and proximate a lesion.

[0065] Figure 2 is a side view of one embodiment of the present invention.

[0066] Figure 3A is a side view of one embodiment of the present invention prior to deployment.

[0067] Figure 3B is a side view of the embodiment of Figure 3A in a deployed configuration.

[0068] Figure 4A is a side view of one embodiment of the present invention prior to deployment.

[0069] Figure 4B is a side view of the embodiment of Figure 4A in a deployed configuration.

[0070] Figure 5 is a front view of first, second and inner lumens comprising one embodiment of the steerable sheath of the present invention.

[0071] Figure 6A is a side cutaway view of one embodiment of the present invention.

[0072] Figure 6B is a side cutaway view of one embodiment of the present invention.

[0073] Figure 6C is a side cutaway view of one embodiment of the present invention.

[0074] Figure 6D is an end view of one embodiment of the present invention.

[0075] Figure 7 is a side cutaway view of one embodiment of the present invention.

[0076] Figure 8 is a side cutaway view of one embodiment of the present invention.

[0077] Figure 9 is a side cutaway view of one embodiment of the present invention.

[0078] Figure 10A is a side cutaway view of one embodiment of the present invention.

[0079] Figure 10B is a side cutaway view of one embodiment of the present invention.

[0080] Figure 10C is a side cutaway view of one embodiment of the present invention.

[0081] DETAILED DESCRIPTION OF THE INVENTION

[0082] While the invention is amenable to various modifications and alternative forms, specifics thereof are shown by way of example in the drawings and described in detail herein. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention. [0083] FIG. 1A illustrates a known catheter or sheath 10 comprising a lumen extended partially within a blood vessel V. Guide wire 12 and drive shaft 14 comprising a lumen along which drive shaft is translated and/or rotated, an abrasive element 16, extend distally out of the distal end of catheter 10. As shown, the blood vessel V comprises a curve, with an occlusion or lesion 50 at the bottom wall of the curve within the vessel V. Because the catheter 10 is unable to bend to accommodate the curvature of the vessel V, the guide wire 12 and drive shaft 14 curve along the upper wall of the vessel V, effectively missing the lesion 50.

[0084] Figure 1B shows the blood vessel V and lesion 50 of Fig. 1A. However, catheter 100 comprises a curvature C proximate the distal end 102. Curvature C enables, as illustrated, the guide wire 12 and drive shaft 14 with associated abrasive element 16 to reach further down within the vessel V, i.e., closer to the lower wall and away from the upper wall and lesion 50 than the prior art device of Fig. 1 A. At this point, the abrasive element 16 may contact lesion 50 and drive shaft 14 may be rotated to enable abrasive element 16 to abrade the lesion 50.

[0085] Figure 2 illustrates one embodiment of a steerable catheter 100, comprising a precurved section 104 resulting in a curvature of the catheter 100 in the precurved section 104. Precurved section 104 is preferably proximate the distal end 102 of catheter 100.

[0086] Figures 3A and 3B illustrate the steerable catheter 100 of Fig. 2, with an outer straightener 200. Outer straightener 200 comprises a lumen L within which the steerable catheter 100 is at least partially disposed and wherein the steerable catheter 100 may be translated and/or rotated relative to the steerable catheter 100. As illustrated,

advancement of the outer straightener 200 over the precurved section 104 of steerable catheter effectively straightens, or deforms, the precurved section 104. The deformation or straightening of preformed section 104 of steerable catheter 100 may also be achieved by retraction of the steerable catheter 100 relative to the outer straightener 104. As may be appreciated, the undeformed or precurved curvature of precurved section 104 may be controlled by an incremental coverage of the precurved section 104 by the outer straightener 200 by the methods described above. As a result, the precurved section 104 may comprise a curvature that ranges from a maximum curvature at its undeformed precurved configuration, as in Fig. 2, to a fully straightened deformed configuration as in Fig. 3B. Figure 3 A illustrates an incremental deformation of precurved section 104 by outer straightener 200, wherein the curvature of precurved section 104 is not at its maximum nor is it fully straightened.

[0087] The elements of Figures 3A and 3B may be reversed as shown in Figures 4A and 4B. Thus, steerable catheter 100 comprises a precurved section 104 as described above and a lumen Li therethrough. Inner straightener 300, comprising lumen L ₂ therethrough, is configured to be advanceable and/or rotateable within lumen Li. Lumen L ₂ enables the guide wire 12 and/or the drive shaft 14 of Fig. 1B to translate and/or rotate therein. As the inner straightener 300 is advanced to and in some cases incrementally through the precurved section 104 of steerable catheter 100, the curvature of precurved section 104 may be deformed from a maximum undeformed curvature to a minimum curvature, i.e., a straightened deformed shape as in Figure 4B, and any incremental curvature

therebetween. The degree or increment of advancement of the inner straightener 300 relative to the precurved section 104 determines the deformation of precurved section 104 and, therefore, the curvature thereof. The skilled artisan will now appreciate the incremental steering capabilities of the embodiments shown in Figures 3A/3B and 4A/4B.

[0088] Turning now to Figures 5-7C, an alternate steerable catheter 100’ is illustrated. Fig. 5 is an and view showing central lumen Li, catheter wall W with a first wall lumen L ₃ and a second wall lumen L ₄ spaced apart from each other, the lumens L ₃ and L ₄ are formed within catheter wall W and extend at least partially along the length of catheter 100’. Preferably, lumens L ₃ and L ₄ are spaced at a rotational angle of 180 degrees from each other as shown in Fig. 5. However, alternate rotational angle spacings between L ₃ and L ₄ , e.g., greater or less than 180 degrees, may also be used and are within the scope of the present invention. Lumen Li extends longitudinally through the central portion of catheter 100’ and is defined by wall W. Lumens L3 and L4 formed within wall S and extend from the proximal end 105 of steerable catheter 100’ to a location or terminus that is located proximal to the distal end 102’ of the catheter 100’. Stated differently, L ₃ and L ₄ do not extend all the way through the catheter 100’.

[0089] Figures 6A-6B show steerable catheter 100’ with curvable section 104’ disposed proximate the distal end 102’ of catheter 100’. A first pull wire Pi is disposed in lumen L ₃ and a second pull wire P ₂ is disposed in lumen L ₄ . Accordingly, pull wires Pi and P ₂ are rotationally spaced from each other in accordance with the rotational angle separating lumens L ₃ and L ₄ . Pull wires Pi and P ₂ each comprise a proximal end 106 and a distal end 108 and are shown extending proximally away from the proximal end 105 of steerable catheter 100’.

[0090] As shown, the distal ends 108 of pull wires Pi and P ₂ are attached to a pull ring 110 that may also be disposed within wall W of steerable catheter 100’ . In the illustrated embodiment, pull ring 110 and distal ends 108 of pull wires Pi, P ₂ are positioned proximal to the curvable section 104’. As shown in Fig. 6B, pulling pull wire Pi in the proximal direction may cause the curvable section 104’ to curve in an upward direction while pulling pull wire P ₂ in the proximal direction may cause curvable section 104’ to curve in a downward direction as in Fig. 6C.

[0091] Pull ring 110 of Figures 6A-6C is shown as viewed from the distal end 102’ of catheter 100’ in Figure 6D as embedded in wall W and comprising a circular shape, with attachment to distal ends 108 of pull wires.

[0092] Alternatively, as in Fig. 7, pull ring 110 may be disposed distal to the curveable section 104’, so that pulling pull wires Pi or P ₂ will have similar curving effects as shown in Figures 6B and 6C.

[0093] Still more alternatively, as shown in Figures 8 and 9, the attachment of the distal ends 108 to the catheter 100’ proximate the distal end 102 of catheter 100’ need not comprise a fully circular pull ring 110 as in Figures 6A-6D. Instead, as shown a partial, e.g., semicircular or other shape pull ring 110’ may be provided within wall W to attach to the distal ends 108 of pull wires Pi and P ₂ . Still more alternatively, distal ends 108 of pull wires Pi and P ₂ may simply be embedded within the material of wall W distal to lumens L ₃ and L ₄ . Figure 8 shows the distal ends 108 of pull wires Pi and P ₂ terminating on the proximal side of curvable section 104’.

[0094] Still further, partial pull rings 110’ may be disposed within wall W of catheter 100’ on the distal side of curvable section 104’. As described above, an alternative embodiment may comprise the distal ends of pull wires Pi and P ₂ to simply be embedded in the wall W material distal to lumens L ₃ and L ₄ .

[0095] Figures 10A-10B illustrate an embodiment of steerable catheter 100’ comprising push wires P ₃ and P ₄ rather than pull wires Pi and P ₂ of the previously described embodiments. However, the skilled artisan will readily recognize that a wire of sufficient stiffness may be used to both pull and to push, as shown by the double-sided arrows of Figures 7-9.

[0096] Thus, as in Figure 10B, pushing top push wire P ₃ results in curvable section 104’ curving away from the straightened undeformed configuration of Figure 10A while pushing bottom wire P ₄ results in curvable section 104’ curving in a different direction away from the straightened configuration of Figure 10A.

[0097] As described previously, whether pull wires Pi, P ₂ , push wires P ₃ , P ₄ or a combination of push/pull wires are employed, the distal ends of the wires may be attached either on the proximal side of the curvable region 104’ or on the distal side of curvable region 104’.

[0098] We note further that pull Pi, P ₂ and/or push wires P ₃ , P ₄ may be of same or similar length, or may be unequal in length. In certain embodiments, therefore, the terminus or location of the distal end 108 of one or more push and/or pull wires comprise variable distance(s) from the distal end 102’ of catheter 100’.

[0099] Moreover, the skilled artisan will recognize that more than two lumens in catheter wall W may be used, wherein each lumen may either be equally rotationally spaced from adjacent lumens or unequally rotationally spaced from adjacent lumens.

[00100] The precurving of precurved section 104 may be achieved by heat treatment to provide an undeformed curvature that may be straightened by degrees or increments as discussed herein. This straightening may be achieved using the

straighteners 200, 300 or the pull Pi, P ₂ and/or push P ₃ , P ₄ wires discussed herein.

[00101] Moreover, a shape memory material such as Nitinol may be used to develop a preset curved configuration for precurved section 104.

[00102] Curvable section 104’ may be formed by creating a weakened region along the catheter wall W using, e.g., striations or slits or thinner or more flexible material to enable and encourage curving at the curvable section 104.

[00103] Further, the precurved section 104 may be moved to a preset curvature, or a range of curvatures, by application of heat transmitted from an external heat generator through one or more than one of the push and/or pull wires. This embodiment may comprise a shape memory alloy to facilitate achieving preset curvatures activated by the application of varying degrees of heat.

[00104] According to the above description, the following embodiments, among others, are possible for a steerable sheath or sheath:

[00105] 1. A steerable catheter or sheath comprising a precurved section formed by heat treatment and/or shape memory alloy such as Nitinol.

[00106] 2. The precurved sheath of (1) wherein the precurved section may be straightened incrementally away from the curvature of the precurved section.

[00107] 3. The precurved sheath of (l)-(2), wherein the precurved section may be straightened by translation of an outer straightener or an inner straightener relative to the catheter and precurved section.

[00108] 4. The precurved sheath of (l)-(3) wherein the precurved section may be straightened by pull and/or push wires.

[00109] 5. The precurved sheath or catheter of (4) wherein the pull and/or push wires may be used to move the steerable catheter or sheath from one undeformed shape to a deformed shape.

[00110] 6. A steerable sheath comprising a curvable section, wherein the curvable section may be deformed to a curved configuration.

[00111] 7. The steerable sheath of (6), wherein the deformation to a curved configuration is achieved by a weakened or stressed or striated section on the steerable catheter or sheath.

[00112] 8. The steerable sheath of (6)-(7), wherein the deformation to a curved configuration is achieved by manipulation of pull and/or push wires.

[00113] 9. The steerable sheath of (l)-(8), wherein a deformation from an undeformed configuration to a deformed configuration is achieved using push and/or pull wires disposed in lumens defined in the wall of the steerable catheter.

[00114] 10. The steerable sheath of (l)-(9), wherein the push and/or pull wires comprise distal ends that are located on the proximal side of the precurved section or curvable section.

[00115] 11. The steerable sheath of (1)-(10), wherein the push and/or pull wires comprise distal ends that are located on the distal side of the precurved section or curvable section.

[00116] 12. The steerable sheath of (l)-(l 1) wherein the push and/or pull wires are anchored at their distal ends at a point distal to the terminus of the first and second wall lumens.

[00117] The descriptions of the embodiments and their applications as set forth herein should be construed as illustrative, and are not intended to limit the scope of the disclosure. Features of various embodiments may be combined with other embodiments and/or features thereof within the metes and bounds of the disclosure. Upon study of this disclosure, variations and modifications of the embodiments disclosed herein are possible, and practical alternatives to and equivalents of the various elements of the embodiments will be understood by and become apparent to those of ordinary skill in the art. Such variations and modifications of the embodiments disclosed herein may be made without departing from the scope and spirit of the invention. Therefore, all alternatives, variations, modifications, etc., as may become to one of ordinary skill in the art are considered as being within the metes and bounds of the instant disclosure.