Not Applicable
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.
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.
Various embodiments of the present invention address these, inter alia, issues.
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:
U.S. Pat. No. 6,295,712, “ROTATIONAL ATHERECTOMY DEVICE”;
U.S. Pat. No. 6,494,890, “ECCENTRIC ROTATIONAL ATHERECTOMY DEVICE”;
U.S. Pat. No. 6,132,444, “ECCENTRIC DRIVE SHAFT FOR ATHERECTOMY DEVICE AND METHOD FOR MANUFACTURE”;
U.S. Pat. No. 6,638,288, “ECCENTRIC DRIVE SHAFT FOR ATHERECTOMY DEVICE AND METHOD FOR MANUFACTURE”;
U.S. Pat. No. 5,314,438, “ABRASIVE DRIVE SHAFT DEVICE FOR ROTATIONAL ATHERECTOMY”;
U.S. Pat. No. 6,217,595, “ROTATIONAL ATHERECTOMY DEVICE”;
U.S. Pat. No. 5,554,163, “ATHERECTOMY DEVICE”;
U.S. Pat. No. 7,507,245, “ROTATIONAL ANGIOPLASTY DEVICE WITH ABRASIVE CROWN”;
U.S. Pat. No. 6,129,734, “ROTATIONAL ATHERECTOMY DEVICE WITH RADIALLY EXPANDABLE PRIME MOVER COUPLING”;
U.S. patent application Ser. No. 11/761,128, “ECCENTRIC ABRADING HEAD FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES”;
U.S. patent application Ser. No. 11/767,725, “SYSTEM, APPARATUS AND METHOD FOR OPENING AN OCCLUDED LESION”;
U.S. patent application Ser. No. 12/130,083, “ECCENTRIC ABRADING ELEMENT FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES”;
U.S. patent application Ser. No. 12/363,914, “MULTI-MATERIAL ABRADING HEAD FOR ATHERECTOMY DEVICES HAVING LATERALLY DISPLACED CENTER OF MASS”;
U.S. patent application Ser. No. 12/578,222, “ROTATIONAL ATHERECTOMY DEVICE WITH PRE-CURVED DRIVE SHAFT”;
U.S. patent application Ser. No. 12/130,024, “ECCENTRIC ABRADING AND CUTTING HEAD FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES”;
U.S. patent application Ser. No. 12/580,590, “ECCENTRIC ABRADING AND CUTTING HEAD FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES”;
U.S. patent application Ser. No. 29/298,320, “ROTATIONAL ATHERECTOMY ABRASIVE CROWN”;
U.S. patent application Ser. No. 29/297,122, “ROTATIONAL ATHERECTOMY ABRASIVE CROWN”;
U.S. patent application Ser. No. 12/466,130, “BIDIRECTIONAL EXPANDABLE HEAD FOR ROTATIONAL ATHERECTOMY DEVICE”;
U.S. patent application Ser. No. 12/388,703, “ROTATIONAL ATHERECTOMY SEGMENTED ABRADING HEAD AND METHOD TO IMPROVE ABRADING EFFICIENCY”;
U.S. Pat. No. 9,468,457, “ATHERECTOMY DEVICE WITH ECCENTRIC CROWN”;
U.S. Pat. No. 9,439,674, “ROTATIONAL ATHERECTOMY DEVICE WITH EXCHANGEABLE DRIVE SHAFT AND MESHING GEARS”;
U.S. Pat. No. 9,220,529, “ROTATIONAL ATHERECTOMY DEVICE WITH ELECTRIC MOTOR”;
U.S. Pat. No. 9,119,661, “ROTATIONAL ATHERECTOMY DEVICE WITH ELECTRIC MOTOR”;
U.S. Pat. No. 9,119,660, “ROTATIONAL ATHERECTOMY DEVICE WITH ELECTRIC MOTOR”;
U.S. Pat. No. 9,078,692, “ROTATIONAL ATHERECTOMY SYSTEM”;
U.S. Pat. No. 6,295,712, “ROTATIONAL ATHERECTOMY DEVICE”;
U.S. Pat. No. 6,494,890, “ECCENTRIC ROTATIONAL ATHERECTOMY DEVICE”;
U.S. Pat. No. 6,132,444, “ECCENTRIC DRIVE SHAFT FOR ATHERECTOMY DEVICE AND METHOD FOR MANUFACTURE”;
U.S. Pat. No. 6,638,288, “ECCENTRIC DRIVE SHAFT FOR ATHERECTOMY DEVICE AND METHOD FOR MANUFACTURE”;
U.S. Pat. No. 5,314,438, “ABRASIVE DRIVE SHAFT DEVICE FOR ROTATIONAL ATHERECTOMY”;
U.S. Pat. No. 6,217,595, “ROTATIONAL ATHERECTOMY DEVICE”;
U.S. Pat. No. 5,554,163, “ATHERECTOMY DEVICE”;
U.S. Pat. No. 7,507,245, “ROTATIONAL ANGIOPLASTY DEVICE WITH ABRASIVE CROWN”;
U.S. Pat. No. 6,129,734, “ROTATIONAL ATHERECTOMY DEVICE WITH RADIALLY EXPANDABLE PRIME MOVER COUPLING”;
U.S. patent application Ser. No. 11/761,128, “ECCENTRIC ABRADING HEAD FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES”;
U.S. patent application Ser. No. 11/767,725, “SYSTEM, APPARATUS AND METHOD FOR OPENING AN OCCLUDED LESION”;
U.S. patent application Ser. No. 12/130,083, “ECCENTRIC ABRADING ELEMENT FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES”;
U.S. patent application Ser. No. 12/363,914, “MULTI-MATERIAL ABRADING HEAD FOR ATHERECTOMY DEVICES HAVING LATERALLY DISPLACED CENTER OF MASS”;
U.S. patent application Ser. No. 12/578,222, “ROTATIONAL ATHERECTOMY DEVICE WITH PRE-CURVED DRIVE SHAFT”;
U.S. patent application Ser. No. 12/130,024, “ECCENTRIC ABRADING AND CUTTING HEAD FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES”;
U.S. patent application Ser. No. 12/580,590, “ECCENTRIC ABRADING AND CUTTING HEAD FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES”;
U.S. patent application Ser. No. 29/298,320, “ROTATIONAL ATHERECTOMY ABRASIVE CROWN”;
U.S. patent application Ser. No. 29/297,122, “ROTATIONAL ATHERECTOMY ABRASIVE CROWN”;
U.S. patent application Ser. No. 12/466,130, “BIDIRECTIONAL EXPANDABLE HEAD FOR ROTATIONAL ATHERECTOMY DEVICE”; and
U.S. patent application Ser. No. 12/388,703, “ROTATIONAL ATHERECTOMY SEGMENTED ABRADING HEAD AND METHOD TO IMPROVE ABRADING EFFICIENCY”
U.S. patent application Ser. No. 13/681,398, “ROTATIONAL ATHERECTOMY DEVICE WITH A SYSTEM OF ECCENTRIC ABRADING HEADS”; and
U.S. patent application Ser. No. 15/906,067, “ECCENTRIC SYSTEM OF ABRASIVE ELEMENTS WITH EQUAL MASS FOR ROTATIONAL ATHERECTOMY
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.
The figures and the detailed description which follow more particularly exemplify these and other embodiments of the invention.
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.
The elements of
Turning now to
As shown, the distal ends 108 of pull wires P1 and P2 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 P1, P2 are positioned proximal to the curvable section 104′. As shown in
Pull ring 110 of
Alternatively, as in
Still more alternatively, as shown in
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 P1 and P2 to simply be embedded in the wall W material distal to lumens L3 and L4.
Thus, as in
As described previously, whether pull wires P1, P2, push wires P3, P4 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′.
We note further that pull P1, P2 and/or push wires P3, P4 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′.
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.
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 P1, P2 and/or push P3, P4 wires discussed herein.
Moreover, a shape memory material such as Nitinol may be used to develop a preset curved configuration for precurved section 104.
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.
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.
According to the above description, the following embodiments, among others, are possible for a steerable sheath or sheath:
1. A steerable catheter or sheath comprising a precurved section formed by heat treatment and/or shape memory alloy such as Nitinol.
2. The precurved sheath of (1) wherein the precurved section may be straightened incrementally away from the curvature of the precurved section.
3. The precurved sheath of (1)-(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.
4. The precurved sheath of (1)-(3) wherein the precurved section may be straightened by pull and/or push wires.
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.
6. A steerable sheath comprising a curvable section, wherein the curvable section may be deformed to a curved configuration.
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.
8. The steerable sheath of (6)-(7), wherein the deformation to a curved configuration is achieved by manipulation of pull and/or push wires.
9. The steerable sheath of (1)-(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.
10. The steerable sheath of (1)-(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.
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.
12. The steerable sheath of (1)-(11) 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.
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.
This application claims the benefit of U.S. Provisional Application No. 62/641,625, filed Mar. 12, 2018 and entitled STEERABLE SHEATH FOR ATHERECTOMY DEVICES AND SYSTEMS, the entirety of which is hereby incorporated by reference.
Number | Date | Country | |
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62641625 | Mar 2018 | US |