Catheter sheath for acoustically amplifying laser-induced pressure waves

Abstract

The present disclosure relates generally to the use of medical devices for treating vascular disease. In particular, the present disclosure provides devices and methods for using laser-induced pressure waves generated within a sheath to disrupt intimal and medial calcium within a vessel.

Description

[0001] Cross-references to related applications

[0002] none. Technical Field

[0003] This disclosure generally relates to the use of medical devices for treating vascular diseases. Specifically, this disclosure provides materials and methods for using laser-induced pressure waves to disrupt vascular obstructions and deliver therapeutic agents to the obstructed area. Background Technology

[0004] Artery disease is a common ailment affecting millions of Americans. Coronary artery disease (CAD) is most commonly caused by a condition called atherosclerosis, which typically manifests as a buildup of a waxy substance inside a person's coronary arteries. This substance, called plaque, is formed from cholesterol, fatty compounds, calcium, and a clotting factor called fibrin. Similarly, peripheral artery disease (PAD) often results from the buildup of plaque inside a person's peripheral arteries, such as those in a patient's arm, hand, leg, and / or foot.

[0005] As plaque accumulates in the coronary arteries, peripheral arteries, and other arteries, the corresponding arteries narrow and / or become stenotic, making it more difficult for blood to flow through them. As the size of the stenosis increases and the blockage worsens, blood flow slows, and in the event of total vascular occlusion, blood flow through the corresponding artery stops completely. This can lead to limb pain and, in severe cases, gangrene, which may ultimately require amputation.

[0006] Balloon angioplasty and other transluminal medical treatments are well-known and have proven effective in treating stenotic lesions at the core of CAD and / or PAD, provided the artery is only partially blocked rather than completely blocked. In a typical angioplasty for CAD, a catheter is inserted into the subject's groin or arm and guided forward through the aorta and into the coronary arteries of the heart. Angioplasty catheters include a balloon that, when placed at the site of partial occlusion, can inflate to widen the blockage or restriction and increase the size of the artery's diameter to provide more typical blood flow through it.

[0007] Over time, a vascular occlusion, particularly a total occlusion, can calcify and / or become fibrotic, reducing the ability to balloon expand the vascular occlusion. Some types of catheters, such as an electrically induced shockwave balloon catheter, can be used to break up calcified tissue. An electrically induced shockwave balloon catheter can include a balloon filled with a liquid and one or more pairs of electrodes positioned within the balloon. When an electrical discharge is created across the electrodes, a plasma is created, which causes one or more bubbles to form. The bubbles created within the balloon cause the balloon to expand and contract. The expansion and contraction of the balloon creates a hydraulic pressure that delivers energy to the vascular occlusion and / or the vessel wall in an amount sufficient to break up calcifications within the lumen and within the tissue layers of the vessel (e.g., calcified deposits). In addition to the bubbles created when the plasma is formed by the electrical reaction in the liquid, a shockwave is also created. The shockwave is transmitted through the balloon to the calcified vascular occlusion, and the shockwave alters the calcified occlusion.

[0008] In the case of a total stenotic occlusion, it can be difficult for a balloon to access the stenosis. Moreover, if the total occlusion is calcified and / or becomes fibrotic, increasing the hardness of the occlusion, it can become even more difficult, if not impossible, to penetrate the occlusion and insert a balloon catheter. For example, the proximal and / or distal ends of the occlusion can become calcified to the point of creating a "cap" or "calcified cap" such that even an electrically induced shockwave balloon catheter can not be able to penetrate the calcified total occlusion because the balloon must be within and adjacent to the occlusion in order to operate. Moreover, because the balloon within an electrically induced shockwave balloon catheter is typically proximal to the distal end of the electrically induced shockwave balloon catheter, it cannot be inserted or passed through the calcified cap of a total occlusion.

[0009] It is also known to use a laser catheter surrounded by a sheath to generate a laser-induced pressure wave to break up a calcified cap or calcified tissue within a vessel to increase the compliance of the vessel. However, using a laser catheter to generate a pressure wave to break up calcifications has its challenges, particularly when using a laser catheter to generate a pressure wave in a smaller sized vessel, such as a peripheral vessel below the knee of a patient. As such, it is desirable for the laser catheter to emit an amount of energy that will translate into a predetermined pressure wave that will break up the calcifications in the vessel itself or in the various layers of the vessel. However, smaller sized vessels require a laser catheter having a reduced diameter to access the vessel, and a smaller sized laser catheter can have limitations on the amount of energy that can be delivered. That is, a reduced sized laser catheter can have fewer optical fibers or smaller diameter optical fibers than a larger sized laser catheter, thereby limiting the amount of energy that a reduced sized laser catheter can deliver before damage to the optical fibers. That is, if the optical fibers attempt to transmit too much energy, they can be damaged.

[0010] One way to compensate for the reduction in energy delivered and emitted by a laser catheter includes increasing the amount of contrast agent in the liquid medium within the outer sheath. The transmission of pulses of light energy into the liquid medium creates a vapor bubble. Vapor bubbles can be created inside the sheath and / or outside the sheath when light is emitted from an emitter, such as a laser catheter, within a sheath containing an absorptive liquid medium. Assuming that the vapor bubble is created inside the sheath, it can be desirable to limit the potential expansion of some or all of the relevant portion of the sheath caused by the vapor bubble. That is, it can be desirable to reduce the size of the vapor bubble created within the sheath to reduce or prevent the sheath from exerting hydraulic or pressure forces against the vessel occlusion and / or the vessel wall. Also, assuming that the vapor bubble is created outside the sheath that is located within the vessel wall, it can be desirable to reduce and / or prevent the formation of such vapor bubbles in order to reduce or prevent the formation of cavitation events and vapor bubbles themselves from exerting hydraulic or pressure forces against the vessel occlusion and / or the vessel wall. However, increasing the amount of contrast agent can create vapor bubbles of undesirable sizes within or outside the sheath, which can potentially damage the vessel.

[0011] In other words, the size of the vapor bubble created depends at least in part on the degree of absorption of the light energy by the liquid medium and the total amount of energy deposited by the light source. Generally speaking, the greater the absorption of the light energy by the liquid medium, the greater the force generated by the laser-induced pressure wave. Also, the greater the amount of light energy transmitted to the liquid medium, the greater the force generated by the laser-induced pressure wave. However, if the liquid medium absorbs too much energy, vapor bubbles of undesirable sizes can be created, and the vessel can be potentially damaged. SUMMARY

[0012] What is now needed is a device and method for penetrating calcified and / or fibrous vessel occlusions, especially calcified caps, and breaking at least a portion of the vessel occlusion as the device penetrates and traverses the fully occluded vessel. What is also needed is a device that is capable of delivering laser-induced pressure waves to a vessel occlusion in order to break the calcified and / or fibrous portions without exerting hydraulic pressure against it. These and other needs are addressed by aspects, embodiments, and configurations of the present disclosure. For example, the present disclosure discusses a sheath having multiple layers to increase the index of reflection of the pressure wave without increasing the size of undesirable vapor bubbles. The sheath has a composite structure that mimics an anisotropic metamaterial to increase the amplitude of the pressure wave transmitted through the sheath.

[0013] An example of a method for improving compliance of a blood vessel in a subject includes determining a location of a calcified portion within a media of a blood vessel of a subject; positioning a laser catheter within a vessel of the subject, the catheter including a proximal end, a distal end, and at least one emitter disposed adjacent the distal end; positioning a sheath over the laser catheter positioned within the vessel of the subject, wherein the sheath includes a proximal end and a distal end, wherein the sheath includes a first layer forming a lumen, a plurality of pairs of attenuating members radially outward of the first layer, and an intermediate layer, wherein the attenuating members are comprised of a first material having a first thickness and a first hardness, the intermediate layer is comprised of a second material having a second thickness and a second hardness, wherein the first hardness is greater than the second hardness, and the first thickness and the second thickness are different; positioning the sheath within the vessel such that the attenuating members are disposed adjacent a portion of the calcified portion within the media of the blood vessel; positioning the laser catheter within the vessel such that the at least one emitter is positioned within the attenuating members and adjacent the portion of the calcified portion within the media of the blood vessel; introducing a liquid medium into the sheath and to the at least one emitter; and emitting a plurality of pulses of light energy from the at least one emitter into the liquid medium, wherein the plurality of pulses of light energy react with the liquid medium and generate a plurality of propagating laser-induced pressure waves that disrupt the calcified portion of the media, thereby improving compliance of the blood vessel.

[0014] Another example is the method of any of the preceding paragraphs, further comprising the step of repositioning the sheath such that the attenuating members are adjacent another calcified portion of the media.

[0015] Another example is the method of any of the preceding two paragraphs, further comprising the step of repositioning the laser catheter within the sheath such that the one or more emitters are adjacent the other calcified portion of the media.

[0016] Another example is the method of any of the preceding three paragraphs, wherein the laser catheter is repositioned within the attenuating members.

[0017] Another example is the method of any of the preceding four paragraphs, further comprising the step of repositioning the laser catheter within the sheath.

[0018] Another example is the method of any of the preceding five paragraphs, wherein the laser catheter is repositioned within the attenuating members.

[0019] Another example is the method of any of the preceding six paragraphs, further comprising the steps of removing the laser catheter from the vessel and removing the sheath from the vessel.

[0020] An example of a method for performing atherectomy in a subject having a vessel occlusion within a vessel of the subject, includes inserting a guide wire through the vessel occlusion within the vessel; introducing a laser catheter into the vessel and over the guide wire, wherein the laser catheter includes at least one emitter; ablating at least a portion of the vessel occlusion with the laser catheter; introducing a sheath into the vessel and over the laser catheter, wherein the sheath includes a proximal end and a distal end, wherein the sheath includes a first layer forming a lumen, a plurality of pairs of attenuating members radially outward of the first layer, and a middle layer, wherein the attenuating members are comprised of a first material having a first thickness and a first hardness, the middle layer is comprised of a second material having a second thickness and a second hardness, wherein the first hardness is greater than the second hardness, wherein the first thickness and the second thickness are substantially equal; positioning the sheath within the vessel such that the attenuating members are disposed radially adjacent to a calcified portion within the vessel; positioning the laser catheter within the vessel such that the at least one emitter is positioned within the attenuating members and radially adjacent to the calcified portion; introducing a liquid medium into the sheath and to the at least one emitter; and emitting a plurality of pulses of light energy from the at least one emitter into the liquid medium, wherein the plurality of pulses of light energy react with the liquid medium and generate a plurality of propagating laser-induced pressure waves that disrupt the calcified portion.

[0021] Another example is the method of the preceding paragraph, further comprising extending the laser catheter distally of the sheath and ablating another portion of the second vessel occlusion; positioning the sheath within the vessel such that the attenuating members are disposed radially adjacent to a second calcified portion of the second vessel occlusion; positioning the laser catheter within the vessel such that the at least one emitter is positioned within the attenuating members and radially adjacent to the second calcified portion; introducing a liquid medium into the sheath and to the at least one emitter; and emitting a plurality of pulses of light energy from the at least one emitter into the liquid medium, wherein the plurality of pulses of light energy react with the liquid medium and generate a plurality of propagating laser-induced pressure waves that disrupt the second calcified portion.

[0022] An example of a catheter system of the present disclosure includes a laser catheter including a proximal end, a distal end, and at least one emitter disposed adjacent to the distal end, a sheath configured to be disposed over the laser catheter and configured to receive a liquid medium, the sheath including a proximal end and a distal end, wherein the sheath includes a first layer forming a lumen, a plurality of pairs of attenuating members radially outward of the first layer, and a middle layer, wherein the attenuating members are comprised of a first material having a first thickness and a first hardness, the middle layer is comprised of a second material having a second thickness and a second hardness, wherein the first hardness is greater than the second hardness.

[0023] Another example is the catheter system of the preceding paragraph, wherein the first thickness and the second thickness are different.

[0024] Another example is the catheter system described in the preceding paragraph, in which the first thickness and the second thickness are substantially equal.

[0025] Another example is the conduit system described in the preceding paragraph, where the difference between the first hardness and the second hardness is approximately Shore hardness 10D.

[0026] Another example is the conduit system described in the preceding paragraph, where the difference between the first hardness and the second hardness is approximately Shore hardness 20D.

[0027] Another example is the conduit system described in the preceding paragraph, where the difference between the first hardness and the second hardness is approximately Shore hardness 30D.

[0028] As used herein, “at least one,” “one or more,” and “and / or” are open-ended expressions that are both combined and separate in application. For example, each of the expressions “at least one of A, B, and C,” “at least one of A, B, or C,” “one or more of A, B, and C,” “one or more of A, B, or C,” and “A, B, and / or C” refers to a single A, a single B, a single C, A and B together, A and C together, B and C together, and A, B, and C together. When each of A, B, and C in the above expressions refers to an element (e.g., X, Y, and Z) or a class of elements (e.g., X1-X), the meaning is different. n Y1-Y m and Z1-Z o When used, this phrase is intended to refer to a single element selected from X, Y, and Z, or a combination of elements selected from the same category (e.g., X1 and X2), or a combination of elements selected from two or more categories (e.g., Y1 and Z). o ).

[0029] It should be noted that the term "a" or "an" entity refers to one or more of the same entity. Therefore, the terms "a" (or "an"), "one or more," and "at least one" are used interchangeably herein. It should also be noted that the terms "comprising," "including," and "having" are used interchangeably.

[0030] Unless otherwise specifically mentioned herein, the term “approximately” when used with a numerical value shall refer to ten percent (10%) of that value.

[0031] As used herein, the term "attenuation component" refers to any component that alters cavitation events and / or bubbles. An example of an attenuation component is an element that has minimal impact on laser-induced pressure waves but can still alter cavitation events and / or bubbles. An example of an attenuation component is a porous attenuation component. However, attenuation components do not need to be porous and can include solid constructions.

[0032] The term "catheter" as used herein generally refers to a tube that can be inserted into a body lumen, duct, lumen, or vessel (e.g., vasculature). In most uses, a catheter is a relatively thin, flexible tube ("soft" catheter), but in some uses it can also be a larger, solid, less flexible (but possibly still flexible) catheter ("hard" catheter). In some uses, a catheter can include a lumen along some or all of its length to allow for the introduction of other catheters or guide wires. An example of a catheter is a sheath.

[0033] The term "balloon catheter" as used herein generally refers to various types of catheters that carry a balloon for containing a fluid. Balloon catheters can also have a wide variety of internal structures (e.g., different lumen designs), with at least three basic types existing: triple lumen, dual lumen, and coaxial lumen. It is intended herein to include all variations in internal structure and design variations by use of the term "balloon catheter." In some uses, a balloon catheter can be used to perform angioplasty.

[0034] The term "cavitation event" as used herein describes a rapid fluid movement that causes a vapor bubble to collapse to its minimum radius. In some cases, a cavitation event can include the generation of a pressure wave.

[0035] The term "coupler" or "fiber coupler" refers to a fiber optic device having one or more input fibers or emitters and one or more output fibers or emitters. A fiber coupler is typically a special fiber optic device having one or more input fibers or emitters for coupling those fibers or emitters to an energy source. The energy source can be another fiber or emitter carrying optical energy that is coupled to one or more additional fibers or emitters.

[0036] The term "emitter" as used herein refers to an optical fiber or optical component (including any portion thereof, such as the end of an optical fiber) that emits light from the distal end of a device (such as a catheter) toward an intended target. In some uses, the target can be tissue or an absorptive medium, such as a contrast fluid. An emitter can be the output end of any device that transfers light from a light source to a target or treatment area. These light energy transfer devices can include glass or fused silica optical fibers, plastic optical fibers, air or gas light guides, and liquid light guides. As described herein, one or more emitters can be used to emit light of any wavelength. One or more emitters can emit light including, but not limited to, laser light, white light, visible light, infrared light, and ultraviolet light.

[0037] In accordance with the present disclosure, the catheter includes at least one emitter, which can include glass or fused silica optical fibers, plastic optical fibers, air or gas light guides, and liquid light guides. Examples of liquid light guides or catheters including liquid light guides can be found in U.S. Application Ser. No. 11 / 923,488, filed October 24, 2007, and U.S. Application Ser. No. 12 / 254,254, filed October 20, 2008, both of which are hereby incorporated by reference in their entirety for all purposes.

[0038] The term "flexible structure" as used herein shall mean a structure that is capable of bending or otherwise conforming to the shape of a vessel as it passes therethrough. The term "radially flexible structure" shall include a flexible structure that is also capable of expanding and / or contracting in a radial direction as a laser-induced pressure wave passes therethrough.

[0039] "Laser emitter" as used herein refers to an end portion of an optical fiber or optical component that emits laser light from the distal end of the catheter toward an intended target. In some uses, the target can be tissue or an absorptive medium, such as a contrast fluid.

[0040] The term "laser-induced pressure wave" as used herein is a pressure wave resulting from a reaction between a laser and an absorptive material. Laser-induced pressure waves can be generated in a gas, a liquid (e.g., saline that can or can not include a contrast medium), or a solid.

[0041] The term "means" as used herein shall be given its broadest possible interpretation in accordance with 35 U.S.C. § 112(f). Accordingly, claims containing the term "means" shall cover all structures, materials, or acts for which the term "means" is synonymous with in this document. Further, structures, materials, or acts for which equivalents are sought under 35 U.S.C. § 112(f) are intended to be covered by this specification, including any priority document(s) or application(s) incorporated herein by reference. In this document, the terms "including" and "comprising" are used in their open-ended, non-limiting sense.

[0042] The term "optical fiber" (or laser-active optical fiber) as used herein refers to a flexible transparent fiber made of an optically transmissive material (e.g., glass (silica) or plastic) that functions as a waveguide or "light pipe" to transport light between the two ends of the fiber.

[0043] The term "porous attenuating member" as used herein shall mean an attenuating member comprised of a rigid or semi-rigid member having openings therein. Examples of rigid and semi-rigid members include members comprised of wire coils, braids, laser cut tubes, reinforced polymer extrusions, patterned plastics, metals, and ceramics. Specific materials used to comprise such rigid and semi-rigid members can include nitinol (which is a nickel-titanium alloy), stainless steel, titanium, silver, aluminum, cobalt, chromium, nylon, pebax, silicone, polyurethane, polyethylene and its derivatives, nylon, polytetrafluoroethylene and its derivatives, polyethylene terephthalate, polypropylene, polyether ether ketone, hydroxyapatite, alumina, tricalcium phosphate, silicates, or other biocompatible metals, ceramics, or polymers. Possible configurations of porous attenuating members include, but are not limited to, helical cuts, interrupted helical cuts, honeycombs, lattice structures commonly found in vascular stents, slots, offset slots, spirals, longitudinal, radial, circumferential, or combinations thereof, openings shaped as cuts. The scope of the present disclosure also includes "porous attenuating members" comprised of flexible structures and / or radially flexible structures, although it can be preferred that the attenuating member be comprised of a rigid or semi-rigid member.

[0044] The term "rigid structure" as used herein shall mean a structure that is capable of bending or otherwise conforming to the shape of a vessel as it passes therethrough, but that is substantially unable to expand and / or contract in a radial direction as a laser-induced pressure wave passes therethrough.

[0045] The term "semi-rigid structure" as used herein shall mean a structure that is partially rigid and has an additional degree of flexibility as it passes through a vessel, but that is substantially unable to expand and / or contract in a radial direction as a laser-induced pressure wave passes therethrough.

[0046] The term "sheath" as used herein shall generally mean a tube that can be inserted into a body lumen, duct, lumen, or vessel (e.g., vasculature) that allows for the introduction of a catheter and the introduction of a fluid along its length. An example of a catheter that can be introduced into a sheath is a laser catheter. An example of a fluid that can be introduced into a sheath is an absorbent fluid, such as a contrast agent. A sheath can have a closed end or an open end. Because a sheath is a tube that can be inserted into a body lumen, duct, lumen, or vessel (e.g., vasculature), a sheath can also be considered a catheter. Accordingly, a catheter (such as a laser catheter) can be introduced into another catheter.

[0047] The term "therapeutic agent" as used herein generally refers to any known or later discovered pharmacologically active agent that provides a treatment for a subject by alleviating one or more of the subject's physiological symptoms. The therapeutic agent can be a naturally occurring compound, a chemically modified naturally occurring compound, or a chemically synthesized compound. The agent is typically selected from the recognized classes of pharmacologically active agents, including but not limited to the following: analgesics; anesthetics; antiarthritics; respiratory agents (including antiasthmatics); anticancer agents (including antineoplastics); anticholinergics; anticonvulsants; antidepressants; antidiabetics; antidiarrheals; antihelminthics; antihistamines; antihyperlipidemics; antihypertensives; anti-infectives (e.g., antibiotics and antivirals); antiinflammatories; antimigraine preparations; anorectal agents; antiparkinson agents; antipruritics; antipsychotics; antipyretics; antispasmodics; antituberculars; antiulceratives; antivirals; anxiolytics; appetite suppressants; attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD) agents; cardiovascular agents (including calcium channel blockers, CNS agents); beta blockers and antiarrhythmics; central nervous system stimulants; cough and cold preparations (including decongestants); diuretics; genetic materials; herbal agents; hormone blockers; hypnotics; hypoglycemics; immunosuppressants; leukotriene inhibitors; mitotic inhibitors; restenosis inhibitors; muscle relaxants; narcotic antagonists; nicotine; nutritional agents (e.g., vitamins, essential amino acids, and fatty acids); ophthalmic agents (e.g., antiglaucoma agents); parasympatholytics; psychostimulants; sedatives; steroids; sympathomimetics; tranquilizers; and vasodilators (including coronary, peripheral, and cerebral vasodilators).

[0048] The term "vapor bubble" as used herein is a gaseous chamber created in a liquid.

[0049] The terms "vasculature" and "vessel" as used herein refer to any portion of a subject's circulatory system (including peripheral and non-peripheral arteries and veins). The vasculature can be composed of materials such as nucleic acids, amino acids, carbohydrates, polysaccharides, lipid fibrous tissue, calcium deposits, dead cell remnants, cellular debris, and the like.

[0050] The term "vessel occlusion" or "occlusion" refers to the accumulation of fat, lipid, fibrin, fibrocalcific plaque, thrombus, and other atherosclerotic tissue within the lumen of a vessel or within the intima of an artery, which narrows the internal lumen of the artery or completely blocks the internal lumen of the artery, thereby limiting or blocking normal blood flow through the segment of the artery. An occlusion can partially or completely occlude the vasculature. Thus, the term "vessel occlusion" or "occlusion" shall include both complete occlusions and partial occlusions. Alternatively, a vessel occlusion or occlusion can also be referred to as a vessel blockage (or blockage) or a vessel restriction (or restriction). Thus, a vessel blockage can refer to a complete blockage or a partial blockage, while a vessel restriction can refer to a complete restriction or a partial restriction.

[0051] It is to be understood that every maximum numerical limitation given throughout this disclosure is deemed to include each and every lower numerical limitation, as if such lower numerical limitations were expressly written herein. Every minimum numerical limitation given throughout this disclosure is deemed to include each and every higher numerical limitation, as if such higher numerical limitations were expressly written herein. Every numerical range given throughout this disclosure is deemed to include each and every narrower numerical range that falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein.

[0052] The foregoing is a simplified summary of the disclosure to provide an understanding of some aspects of the disclosure. The summary is neither an extensive nor exhaustive overview of the disclosure and its various aspects, embodiments and configurations. It is intended to neither identify key or critical elements of the disclosure nor delineate the scope of the disclosure but to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description presented below. As will be appreciated, other aspects, embodiments and configurations of the disclosure can utilize one or more of the features described above or in the detailed description below. BRIEF DESCRIPTION OF DRAWINGS

[0053] The accompanying drawings are incorporated in and constitute a part of this specification, illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the disclosure. The drawings simply show preferred and alternative examples of how the present disclosure can be made and used, and should not be construed to limit the present disclosure to the examples shown and described. Other features and advantages will become apparent from the following detailed description of the examples, taken in conjunction with the accompanying drawings.

[0054] FIG. 1 An exemplary ablation system is shown, including a laser generator and a laser-induced pressure wave emitting catheter sheath;

[0055] FIG. 2 is a perspective view of a laser catheter and guidewire according to one embodiment of the present disclosure;

[0056] FIG. 3A is a perspective view of a kit within a vessel of a patient, wherein the kit includes a laser catheter according to one embodiment of the present disclosure, the laser catheter being radially disposed within a sheath and over a guidewire, wherein the kit and guidewire are disposed proximal to a vessel occlusion;

[0057] FIG. 3B is a perspective view of a kit within a vessel of a patient, wherein the kit includes a laser catheter according to one embodiment of the present disclosure, the laser catheter being radially disposed within a sheath and over a guidewire, wherein the kit is disposed proximal to a vessel occlusion and the guidewire has penetrated the vessel occlusion;

[0058] FIG. 3C is a perspective view of a kit within a vessel of a patient, wherein the kit includes a laser catheter according to one embodiment of the present disclosure, the laser catheter being radially disposed within a sheath and over a guidewire, wherein the sheath is disposed proximal to a vessel occlusion and the laser catheter and guidewire have penetrated the vessel occlusion;

[0059] FIG. 3D is a perspective view of a kit within a vessel of a patient, wherein the kit includes a laser catheter according to one embodiment of the present disclosure, the laser catheter being radially disposed within a sheath and over a guidewire, wherein the kit and guidewire have penetrated the vessel occlusion;

[0060] FIG. 4 is a representative flowchart of a method of treating a subject using a laser catheter and sheath according to one embodiment of the present disclosure;

[0061] FIG. 5 is a perspective view of an outer sheath including an attenuation member according to one embodiment of the present disclosure;

[0062] FIG. 5A is a side view of an attenuation member including a plurality of square openings according to one embodiment of the present disclosure;

[0063] FIG. 5B is a side view of an attenuation member including a plurality of diamond-shaped openings according to one embodiment of the present disclosure;

[0064] FIG. 5C is a side view of an attenuation member including a plurality of openings formed by a helical structure wound in a particular direction according to one embodiment of the present disclosure;

[0065] FIG. 5D is a side view of an attenuation member including a plurality of openings formed by a helical structure wound in a particular direction according to one embodiment of the present disclosure;

[0066] FIG. 5E is a side view of an attenuation member including a plurality of openings formed by helically wound tape according to one embodiment of the present disclosure;

[0067] FIG. 5F is a side view of an attenuation member including a plurality of hexagonal openings according to one embodiment of the present disclosure; and

[0068] FIG. 6 is a representative flowchart of a method of treating a subject using a laser catheter and sheath according to one embodiment of the present disclosure.

[0069] FIG. 7 is a cross-sectional view of an arterial wall taken in a direction perpendicular to a longitudinal axis of the arterial wall.

[0070] FIG. 7A is a scaled down version of a cross-sectional view of an arterial wall in FIG. 7

[0071] FIG. 8A is a longitudinal cross-sectional view of a healthy arterial wall taken in a direction parallel to a longitudinal axis of the arterial wall.

[0072] FIG. 8B is a longitudinal cross-sectional view of an arterial wall taken in a direction parallel to a longitudinal axis of the arterial wall, wherein the arterial wall includes fat and / or lipids.

[0073] FIG. 8C is a longitudinal cross-sectional view of an arterial wall taken in a direction parallel to a longitudinal axis of the arterial wall, wherein the arterial wall includes a plaque and calcium located in the intima.

[0074] FIG. 8D is a longitudinal cross-sectional view of an arterial wall taken in a direction parallel to a longitudinal axis of the arterial wall, wherein the arterial wall includes a calcified plaque and lipids located in the intima.

[0075] FIG. 8E is a longitudinal cross-sectional view of an arterial wall taken in a direction parallel to a longitudinal axis of the arterial wall, wherein the arterial wall has ruptured.

[0076] FIG. 8F is a longitudinal cross-sectional view of an arterial wall taken in a direction parallel to a longitudinal axis of the arterial wall, wherein the artery includes an occlusion.

[0077] FIG. 8G is a longitudinal cross-sectional view of an arterial wall taken in a direction parallel to a longitudinal axis of the arterial wall, wherein the laser catheter having an occlusion depicted in FIG. 8F

[0078] FIG. 8H ​​is a longitudinal section view of an arterial wall taken in a direction parallel to a longitudinal axis of the arterial wall, wherein the sheath and the laser catheter are disposed adjacent to a portion of the arterial wall that includes a calcified medial portion of the blood vessel. FIG. 8G is a longitudinal section view of an arterial wall taken in a direction parallel to a longitudinal axis of the arterial wall, wherein the sheath and the laser catheter are disposed adjacent to a portion of the arterial wall that includes a calcified medial portion of the blood vessel.

[0079] FIG. 8H is a longitudinal section view of an arterial wall taken in a direction parallel to a longitudinal axis of the arterial wall, wherein the sheath and the laser catheter are disposed adjacent to a portion of the arterial wall that includes a calcified medial portion of the blood vessel. FIG. 8G is a longitudinal section view of an arterial wall taken in a direction parallel to a longitudinal axis of the arterial wall, wherein the sheath and the laser catheter are disposed adjacent to a portion of the arterial wall that includes a calcified medial portion of the blood vessel.

[0080] FIG. 8I is a longitudinal section view of an arterial wall taken in a direction parallel to a longitudinal axis of the arterial wall. FIG. 8H and / or FIG. 8H is a longitudinal section view of an arterial wall taken in a direction parallel to a longitudinal axis of the arterial wall.

[0081] FIG. 9A and FIG. 9B is a method of removing a restrictive vascular occlusion and disposing of a remaining portion of the vascular occlusion located in the intima using a sheath and a laser catheter.

[0082] FIG. 10A is a longitudinal section view of a healthy arterial wall taken in a direction parallel to a longitudinal axis of the arterial wall (similar to the arterial wall illustrated in FIG. 8A ).

[0083] FIG. 10B is a longitudinal section view of an arterial wall taken in a direction parallel to a longitudinal axis of the arterial wall, wherein a calcified medial portion of the blood vessel is disrupted.

[0084] FIG. 10C is a longitudinal section view of an arterial wall taken in a direction parallel to a longitudinal axis of the arterial wall, wherein the sheath and the laser catheter are disposed adjacent to a portion of the arterial wall that includes a calcified medial portion of the blood vessel.

[0085] FIG. 10D is a longitudinal section view of an arterial wall taken in a direction parallel to a longitudinal axis of the arterial wall, wherein a calcified medial portion of the blood vessel is disrupted.

[0086] FIG. 11 is a method of treating a calcified medial portion of a blood vessel using a sheath and a laser catheter.

[0087] FIG. 12 is a kit comprising a laser catheter assembly and an outer sheath assembly.

[0088] FIG. 12A is FIG. 12enlarged view of the distal portion of the laser catheter assembly and the distal portion of the outer sheath assembly within line 12A-12A of FIG. 12, wherein the laser catheter assembly extends beyond the distal end of the outer sheath assembly, and a portion of the outer sheath assembly is shown as a translucent material for purposes of clarity of the figure.

[0089] FIG. 12B is a longitudinal cross-sectional view of the distal portion of the laser catheter assembly and the distal portion of the outer sheath assembly taken along line B-B of FIG. 13B. FIG. 12A is an enlarged longitudinal cross-sectional view of the distal portion of the laser catheter assembly and the distal portion of the outer sheath assembly illustrated in FIG. 13A, wherein the laser catheter assembly is disposed within the outer sheath assembly and extends beyond the distal end of the outer sheath assembly.

[0090] FIG. 12B is FIG. 12A is an enlarged longitudinal cross-sectional view of the distal portion of the laser catheter assembly and the distal portion of the outer sheath assembly illustrated in FIG. 13B, wherein the laser catheter assembly is disposed within the outer sheath and the distal end of the laser catheter assembly is proximal of the distal end of the outer sheath assembly.

[0091] FIG. 13 is FIG. 12 is the outer sheath assembly illustrated in FIG. 13A.

[0092] FIG. 13A is FIG. 12 is an enlarged view of the distal portion of the outer sheath assembly within line 13A-13A of FIG. 13A, wherein a portion of the outer sheath assembly is shown as a translucent material for purposes of clarity of the figure.

[0093] FIG. 13B is a longitudinal cross-sectional view of the distal portion of the outer sheath assembly taken along line B-B of FIG. 13B. FIG. 13A is an enlarged longitudinal cross-sectional view of the distal portion of the outer sheath assembly illustrated in FIG. 13A.

[0094] FIG. 13C is FIG. 13B is an enlarged longitudinal cross-sectional view of the distal portion of the outer sheath assembly within line 13C-13C of FIG. 13C.

[0095] FIG. 13C is FIG. 13B is an alternative embodiment of the enlarged longitudinal cross-sectional view of the distal portion of the outer sheath assembly illustrated in FIG. 13B.

[0096] FIG. 14 is FIG. 12 is the laser catheter assembly illustrated in FIG. 14A.

[0097] FIG. 14A is FIG. 14 is an enlarged view of the distal portion of the laser catheter assembly within line 14A-14A of FIG. 14A.

[0098] FIG. 15 is a flowchart illustrating steps of a method of using a kit comprising a laser catheter assembly and an outer sheath assembly.

[0099] FIG. 16 is a magnified view of a flat wire disposed in one or more embodiments of an outer sheath assembly.

[0100] FIG. 17 is an outer sheath for a kit that also includes a laser catheter assembly.

[0101] FIG. 17A is a magnified longitudinal section view of a distal portion of the outer sheath taken along line 17A-17A of FIG. 17

[0102] FIG. 18 is a magnified, partially exploded view showing the layers of the outer sheath of FIG. 17

[0103] FIG. 19 is a magnified section view of an alternative configuration of the outer sheath. DETAILED DESCRIPTION

[0104] The present disclosure relates generally to the use of medical devices for treating vascular disease. In particular, the present disclosure provides materials and methods for using laser-induced pressure waves to disrupt vascular obstructions and deliver therapeutic agents to obstructed regions.

[0105] Referring to FIG. 1 , an exemplary ablation system 100 of the present disclosure is illustrated. The ablation system 100 includes a laser device 130 coupled to a laser controller 165. The controller 165 includes one or more computing devices programmed to control the laser 130. The controller 165 can be internal or external to the laser device 130 (e.g., a laser generator). The laser device 130 can include an excimer laser or another suitable laser. In some embodiments, the laser 130 generates light in the ultraviolet frequency range. In one embodiment, the laser 130 generates light energy in the form of pulses.

[0106] The laser 130 is connected to a proximal end of a laser energy delivery system 120 (illustratively, a laser catheter 170) by a coupler 140. The laser catheter 170 includes one or more light energy delivery devices that receive laser energy from the laser 130 and transmit the received laser energy from a first, proximal end 124 of the laser energy catheter 170 toward a second, distal end 126 of the laser catheter 170. The distal end of the catheter 170 can be inserted into a blood vessel or tissue of a human body 110. In some embodiments, the system 100 employs a plurality of light guides as light energy delivery devices, such as optical fibers, that direct laser light from the laser 130 through the catheter 170 toward a target region within the human body 110.

[0107] ​​Exemplary laser catheter devices or assemblies can include laser catheters and / or laser sheaths. Examples of laser catheters or laser sheaths are sold by The Spectranetics Corporation under the trade names ELCA® TM and Turbo Elite TM (each of which is used for coronary interventions or peripheral interventions, such as recanalization of occluded arteries, modification of lesion morphology, and facilitation of stent placement), and SLS II TM and GlideLight TM which is used for lead removal in surgical implantation. The working (distal) end of the laser catheter typically has multiple laser emitters that emit energy and ablate target tissue. The opposite (proximal) end of the laser catheter typically has a fiber coupler 140 and optional strain relief member 124. The fiber coupler 140 is connected to a laser system or generator 130. One such example of a laser system is the CVX-300 excimer laser system, which is also sold by The Spectranetics Corporation.

[0108] FIG. 1 The laser controller 165 of the ablation system 100 includes a non-transitory computer readable medium (e.g., a memory (not shown)) that includes instructions that, when executed, cause one or more processors (not shown) to control the laser 130 and / or other components of the ablation system 100. The controller 165 includes one or more input devices to receive input from an operator. Exemplary input devices include keys, buttons, touchscreens, dials, switches, mice, and trackballs, which provide user control of the laser 130. The controller 165 also includes one or more output devices to provide feedback or information to the operator. Exemplary output devices include displays, lights, audio devices that provide user feedback or information.

[0109] The laser source of the laser 130 is operatively coupled to the laser controller 165. The laser source operatively generates a laser signal or beam and provides the laser signal through a fiber bundle of the catheter 170 to the human. The fiber bundle serves as a transmission device for transmitting the laser signal to the target region of the human body 110.

[0110] FIG. 1A catheter 170 is depicted that enters the leg of a human (preferably through the femoral artery). As described above, it can be desirable to treat CAD or PAD. After entering the femoral artery, if the catheter 170 is to treat CAD, the catheter 170 will pass through the patient’s vasculature and be directed to a coronary artery. Alternatively, if the catheter 170 is to treat PAD, the catheter 170 will pass through the patient’s vasculature and be directed to a peripheral artery, such as a vessel below the knee, specifically a vessel in the patient’s leg and / or foot. Unlike a balloon catheter, the catheter 170 of the present disclosure is able to more easily navigate and enter smaller sized vessels because the overall diameter of the sheath is smaller compared to a balloon catheter, thereby allowing the catheter 170 of the present disclosure to more easily treat PAD. That is, the increased size of the balloon of an electrically induced shockwave balloon catheter and / or a typical dilation balloon catheter (compared to the catheter 170 of the present disclosure) can prevent or increase the difficulty of a balloon-type catheter to enter, penetrate, and / or treat peripheral vessels (e.g., vessels below the knee in the leg and / or foot).

[0111] Reference is made to FIG. 2 , a distal end 126 of a laser catheter 170 and a guidewire 210 extending through the lumen of the catheter 170 are depicted. The laser catheter 170 includes one or more layers of optical fibers 186 surrounding a lumen extending therethrough, and a sheath 182 surrounding the layers of optical fibers 186. The distal end of the laser catheter 170 can include a metal band 180 that improves the strength of the distal end and provides a radiopaque marker. That is, the catheter 170 of the present disclosure can include an outer sheath 182, an inner sheath 184 (not shown), one or more optical fibers 186, and a tip. The outer sheath 182, the inner sheath 184, and the one or more optical fibers 186 generally span the length of the catheter 170, and each has a proximal end and a distal end. The inner sheath 184 is concentrically and / or radially disposed within the outer sheath 182, and the one or more optical fibers 186 are concentrically and / or radially disposed within the inner sheath 184. An example of a laser catheter 170 or laser sheath is sold by The Spectranetics Corporation under the trade name ELCA TM and Turbo Elite TM (each of which is used for coronary intervention or catheter treatment, such as recanalization of occluded arteries, changing lesion morphology, and facilitating stent placement) and SLSII TM and GlideLight TM(used to remove a lead implanted for a surgical procedure). Also, as shown in FIG. 10, the working (distal) end of the laser catheter typically has a plurality of laser emitters that emit energy and ablate the target tissue. The opposite (proximal) end of the laser catheter (not shown) typically has a fiber coupler that is connected to a laser system or generator. One such example of a laser system is the CVX-300 excimer laser system, which is also sold by The Spectranetics Corporation.

[0112] The inner sheath 184, which is composed of a biocompatible polymer, has one or more lumens that are used to deliver a liquid medium to the chamber, thereby partially or completely filling the chamber with the liquid medium. The liquid medium is introduced into the catheter 170 through one or more liquid medium ports (not shown) that are in fluid communication with one or more lumens 190 (not shown) within the inner sheath 184 and disposed about the outer sheath 182. The liquid medium ports can also serve as a means for removing the liquid medium from the catheter 170.

[0113] The liquid medium is configured to absorb light energy, thereby creating a laser-induced pressure wave in the liquid medium. The laser-induced pressure wave compresses the liquid around its origin, thereby creating a vapor bubble. As the laser-induced pressure wave propagates away from its origin, the liquid around the vapor bubble shifts inward, causing the vapor bubble to collapse and creating a cavitation event. The vapor bubble and the subsequent cavitation event are byproducts of the laser-induced pressure wave. Moreover, the subsequent cavitation event creates additional resultant pressure waves that are transmitted to the tip 180 and / or the outer sheath 182 to disrupt the vascular occlusion.

[0114] The liquid medium can include a contrast medium, including, for example, an iodine-containing contrast medium or a gadolinium contrast medium, as well as a contrast solution including a dye and / or particles. Moreover, any liquid medium can be used so long as the liquid medium is coupled with a light source, such as an emitter coupled with one or more optical fibers, that emits light at a suitable wavelength such that the liquid absorbs the light, creating a laser-induced pressure wave, a vapor bubble, and a cavitation event that creates additional resultant pressure waves. In some cases, the liquid medium can be a contrast medium (e.g., an iodine-containing contrast medium or a gadolinium contrast medium) and / or the liquid medium can be a contrast solution including a biocompatible fluid (e.g., saline) in which a contrast dye or particles have been mixed at varying concentrations.

[0115] As described above, one or more optical fibers 186 are disposed within the inner sheath 184, extending from a proximal portion of the inner sheath 184 to the distal end of the inner sheath 184 and into the chamber. The proximal end of the one or more optical fibers is coupled with the laser generator 130. The distal end of the one or more optical fibers 186 is proximal, at, or distal to the distal end of the inner sheath 184. Also, one or more emitters are disposed at the distal end of the one or more optical fibers 186. The emitters are in direct contact with the liquid medium such that when laser light energy is emitted from the emitters, the liquid medium absorbs the emitted light, which in turn generates a laser-induced pressure wave, and creates cavitation events that generate bubbles and additional pressure waves.

[0116] To treat a subject having a vascular occlusion, the tip 180 of the catheter 170 is positioned adjacent to the vascular occlusion. When the laser system 130 is activated, light energy travels through the one or more optical fibers until the light energy is released from the emitters. As a result of the liquid medium absorbing the light energy, a laser-induced pressure wave is generated. In addition, the liquid medium rapidly shifts outwardly and inwardly, creating bubbles. The energy generated by the laser-induced pressure wave is trapped within the chamber and is converted into mechanical energy by the moving tip and / or is transmitted to the vascular occlusion through the tip. The energy generated by the laser-induced pressure wave is transmitted to the vascular occlusion sufficient to disrupt the vascular occlusion, specifically the calcified and / or fibrous (e.g., calcium deposits) portion of the occlusion. It is desirable that the mechanical energy generated by the laser-induced pressure wave at the tip and the fluid displacement created be transmitted to the occlusion. Thus, as the energy generated by the laser-induced pressure wave is trapped within the chamber, it is desirable that the force generated by the laser-induced pressure wave propagate longitudinally, including in a forward (i.e., parallel to the blood vessel) direction, thereby increasing the ability of the tip to disrupt, destroy, and / or penetrate the vascular occlusion. That is, as the laser-induced pressure wave is generated, the tip of the catheter rapidly moves (translates) forward and backward toward and away from the occlusion, respectively. The pressure wave generated in this manner can also be used to increase the vessel compliance prior to performing another procedure, such as a traditional balloon angioplasty or a drug eluting balloon treatment.

[0117] To facilitate the direction along which the force generated by the laser-induced pressure wave is converted into movement of the tip in the forward / backward longitudinal direction, the outer sheath 182 is not only flexible, but the outer sheath 182 also has the ability to expand and contract in the longitudinal direction. One example of such an outer sheath 182 includes a slotted or laser cut hypotube composed of a biocompatible material, such as stainless steel, or a biocompatible polymer. The hypotube has spring-like properties that allow it to expand and contract in the longitudinal direction. Specifically, the pattern of slots or laser cuts in the hypotube allow it to expand and contract. Another example of the outer sheath 182 can include one or more helically wound wires, forming a coiled sheath, that also has the ability to expand and contract in the longitudinal direction.

[0118] The energy generated by producing laser-induced pressure waves is delivered to the vascular occlusion and / or vessel wall, sufficient to disrupt intraluminal calcium and intravascular tissue calcium, vascular occlusions (e.g., calcium deposits). The force generated by the laser-induced pressure waves can propagate radially, including in forward (i.e., parallel to the vessel), upward (i.e., perpendicular to the vessel), and backward (i.e., proximal) directions. Laser-induced pressure waves generated in this way can also be used to increase vascular compliance before performing another procedure such as conventional balloon angioplasty, drug-eluting balloon angioplasty, and / or stent placement. That is, by disrupting intraluminal calcium and / or intravascular tissue calcium and vascular occlusions, the laser-induced pressure waves can improve the vessel's ability to absorb drugs, especially when such drugs are applied using a drug-eluting balloon.

[0119] Refer again FIGS. 3A-3D The catheter system 300 includes a laser catheter 170 disposed within and near the end of a sheath 250, thereby allowing laser-induced pressure waves to propagate radially from the sheath 250 and forward (i.e., parallel to the blood vessel) from the end.

[0120] This disclosure envisions a two-piece catheter system or kit 300. (Reference) FIG. 3A System 300 may include a laser conduit 170 radially disposed within a sheath 250. The system may optionally include a guidewire 210 disposed within the lumen of the laser conduit 170. A liquid medium is introduced into the sheath 250 distal to the laser conduit 170, particularly distal to the fiber / transmitter of the laser conduit 170, such that when the laser is activated, the liquid absorbs the light and generates laser-induced pressure waves and / or bubbles, as well as additional synthetic pressure waves and / or cavitation events. Although the liquid is not shown in the figure, it may be introduced through a lumen in the laser conduit 170, a lumen in the sheath 250, and / or a lumen or space between the laser conduit 170 and the sheath 250. Regardless of which locations are used, one or more liquid medium ports will also be used, located proximally to or towards the conduit system.

[0121] refer to FIG. 4, illustrating a representative flowchart of a method 400 of using a laser catheter 170 to ablate a portion of a vessel occlusion, and / or using a laser catheter 170 in combination with a sheath 250 to generate laser-induced pressure waves in the presence of a liquid medium and to disrupt a portion of a vessel occlusion to remove a restrictive vessel occlusion. The method 400 can include a step 405 of positioning a guidewire 210 within a vessel 185 of a subject, a step 410 of positioning a laser catheter 170 over the guidewire 210 positioned within the vessel, a step 415 of positioning a sheath 250 over the laser catheter 170 positioned within the vessel, and a step 420 of positioning the sheath 250 and the laser catheter 170 (and optionally the guidewire 210) adjacent to a restrictive vessel occlusion 175' within the vessel 185 of the subject. Again with reference to FIG. 3A Positioning the sheath 250 and the laser catheter 170 adjacent to the vessel occlusion 175 creates a chamber for the liquid medium to collect distal of the laser catheter 170, particularly distal of the emitter / fiber of the laser catheter 186.

[0122] FIG. 3A The distal end of the laser catheter 170 is illustrated as being positioned proximal of the distal end of the sheath 250. However, it is contemplated that the distal end of the laser catheter 170 can be positioned at or distal of the distal end of the sheath 250, so long as there is a liquid medium between the emitter / fiber of the laser catheter 170 and the vessel occlusion 175'. The axial position of the laser catheter 170 and the sheath 250 can be adjusted by translating one or both of the components relative to one another. To visualize the respective positions of the laser catheter 170 and the sheath 250 under fluoroscopy, the laser catheter 170 and the sheath 250 can include radiopaque markers at any respective positions along their lengths.

[0123] Continuing with reference to FIG. 3A Once the sheath 250 and the laser catheter 170 are positioned adjacent to the vessel occlusion 175 within the vessel (or blood vessel) 185, a liquid medium can be introduced to the distal end of the laser catheter as described in step 425 of FIG. 4 Continuing with reference to FIG. 4 Step 430 includes activating the laser to generate laser-induced pressure waves in the presence of the liquid medium and to disrupt a portion of the vessel occlusion, specifically the calcified cap of the vessel occlusion. The laser catheter 170 and the sheath 250 can be used to traverse the entire vessel occlusion 175 as described in step 440 of FIG. 4 (and optional step 435 of FIG. 4 If the laser catheter 170 and the sheath 250 are only used to disrupt a portion of the vessel occlusion 175, then the guidewire 210 can penetrate and traverse the vessel occlusion 175. For example, FIG. 3BThe guidewire 210 is shown penetrating and crossing the vessel occlusion 175'.

[0124] Referring to FIG. 3C , assuming that the laser catheter 170 and the sheath 250 are only used to disrupt a portion of the vessel occlusion 175", the laser catheter 250 can be used to cross the vessel occlusion 175" without the sheath 250. Referring to FIG. 4 Step 445 of the procedure, the insertion of the liquid medium can stop, and as the laser catheter 170 crosses the vessel occlusion 175" over the guidewire 210, with the sheath 250 remaining proximal of the vessel occlusion, the laser catheter 170 can be used to ablate the vessel occlusion.

[0125] Once the laser catheter 170 has crossed the entire vessel occlusion, the opening created by the laser catheter 170 should be large enough for the sheath 250 to be translated distally and through the vessel occlusion. At this point, the distal end of the sheath 250 and the distal end of the laser catheter 170 should both be distal of the vessel occlusion. At this point, referring to FIG. 3D , the laser catheter 170 can be translated proximally while the sheath 250 remains stationary within the vessel occlusion. As the liquid medium is introduced within the sheath 250 in front of the laser catheter 170, the laser can be activated to create a laser-induced pressure wave in the presence of the liquid medium. At least a portion of the laser-induced pressure wave is directed radially and, as the laser catheter 170 is translated proximally within the sheath 250, the laser-induced pressure wave is transmitted through the sheath 250 to disrupt the remaining portion of the vessel occlusion 175".

[0126] To ensure that a substantial portion of the remaining portion of the vessel occlusion 175" is disrupted, and if desired, the calcium within the lumen and / or the tissue layer of the vessel (e.g., the media layer) and the vessel occlusion, the laser catheter 170 can be repeatedly translated distally and proximally within the sheath 250. As described above, disrupting the lumen and / or the tissue layer of the vessel (e.g., the media layer) and the vessel occlusion can improve the ability of the vessel to absorb a drug, especially when such drug is applied with a drug eluting balloon. Also, it is contemplated that the laser catheter 170 can be used to ablate a portion of the vessel occlusion alone, prior to, during and / or after any of the steps outlined in FIG. 4

[0127] ​Laser-induced pressure waves generally have different characteristics than ultrasound. Ultrasound generally comprises periodic oscillations with a finite bandwidth. Laser-induced pressure waves are single, primarily positive pressure pulses followed by a relatively small tensile wave component. Ultrasound exerts an alternating high frequency load on tissue, in the frequency range of several megahertz, and can therefore result in heating, tissue laceration, and high amplitude cavitation phenomena. In contrast, however, the effects of laser-induced pressure waves are primarily related to energy directed radially, as described above, which can enable enhanced sensitivity of treatment of deep tissue as well as adjacent tissue.

[0128] The ability of the catheter of the present disclosure to generate laser-induced pressure waves to treat a vascular occlusion in a subject involves the proper coupling of the light system and the liquid medium. Light of any wavelength can be used, including but not limited to laser light, visible light, ultraviolet light, and infrared light, so long as the light emitted is coupled with a liquid medium that is capable of absorbing the light and generating a laser-induced pressure wave. Furthermore, any liquid medium can be used, so long as the liquid medium is coupled with a light source that emits light of the appropriate wavelength such that the liquid absorbs the light and generates a laser-induced pressure wave and / or bubble. In some cases, the liquid medium can be a contrast medium (e.g., an iodine-containing contrast medium or a gadolinium contrast medium) and / or the liquid medium can be a contrast solution comprising a biocompatible liquid (e.g., saline) in which contrast dyes or particles have been mixed at varying concentrations.

[0129] The amplitude of the force generated by the laser-induced pressure wave is dependent in part on the degree of absorption of the light energy by the liquid medium, as well as the total energy deposited by the light source. Generally, the greater the absorption of the light energy by the liquid medium, the greater the force generated by the laser-induced pressure wave. Also, the greater the amount of light energy delivered to the liquid medium, the greater the force generated by the laser-induced pressure wave. For example, excimer lasers typically emit laser light at a wavelength of about 308 nanometers, with a pulse duration of between about 120 nanoseconds and about 140 nanoseconds, a frequency of between about 25 pulses / second to about 80 pulses / second, and a total energy output of between about 1 and about 100 millijoules. However, in some cases, the total energy output of the laser system can range from greater than 0 to about 300 mJ. When emitted within a contrast medium (e.g., an iodine-containing contrast medium or a gadolinium contrast medium), there will be a very high degree of absorption by the contrast medium, resulting in a laser-induced pressure wave with sufficient force to treat a vascular occlusion in a subject.

[0130] The optical energy can be emitted at any suitable wavelength capable of generating a laser-induced pressure wave. The optical energy can be emitted between about 1 nanometer and about 1 millimeter. In some cases, the light can be emitted from about 10 nanometers to about 5000 nanometers. In some cases, the light can be emitted from about 100 nanometers to about 1000 nanometers. In some cases, the light can be emitted from about 250 nanometers to about 750 nanometers. In some cases, the light can be emitted from about 300 nanometers to about 600 nanometers. In other cases, the light can be emitted from about 300 nanometers to about 350 nanometers.

[0131] The optical energy can be emitted at any suitable pulse duration capable of generating a laser-induced pressure wave. In some cases, the light can be emitted at a pulse duration between about 1 femtosecond to about 1 second. In some cases, the light can be emitted at a pulse duration between about 10 nanoseconds to about 500 nanoseconds. In some cases, the light can be emitted at a pulse duration between about 100 nanoseconds to about 150 nanoseconds. In other cases, the light can be emitted at a pulse duration between about 120 nanoseconds to about 140 nanoseconds.

[0132] The optical energy can be emitted at any suitable pulse repetition frequency (PRF) or number of pulses per second capable of generating a bubble and resulting synthetic pressure wave that propagates through surrounding vasculature. In some cases, the light can be pulsed at a frequency between about 1 pulse per second to about 5000 pulses per second. In some cases, the light can be pulsed at a frequency between about 10 pulses per second to about 2500 pulses per second. In some cases, the light can be pulsed at a frequency between about 10 pulses per second to about 1500 pulses per second. In some cases, the light can be pulsed at a frequency between about 100 pulses per second to about 1000 pulses per second. In other cases, the light can be pulsed at a frequency between about 50 pulses per second to about 500 pulses per second. In other cases, the light can be pulsed at a frequency between about 50 pulses per second to about 150 pulses per second. In other cases, the light can be pulsed at a frequency between about 50 pulses per second to about 100 pulses per second. In other cases, the light can be pulsed at a frequency between about 25 pulses per second to about 80 pulses per second.

[0133] The total number of pulses administered during a particular treatment period depends on various factors, including the characteristics of the patient, the type of disorder being treated, and the particular characteristics of the vasculature occlusion, which will be readily understood by one of ordinary skill in the art based on the present disclosure. In some cases, the total number of pulses administered during a treatment period can range from a single pulse to any number of pulses generated over a 10 second treatment period, a 15 second treatment period, a 20 second treatment period, a 25 second treatment period, a 30 second treatment period, up to a 1 minute treatment period. The treatment period can be repeated depending on the extent of vasculature occlusion remaining after the initial treatment.

[0134] For example, the generator and / or one or more emitters can be configured to emit laser energy having a wavelength between about 150 nanometers and about 400 nanometers, a pulse duration between about 1 femtosecond and about 1 second, and a frequency between about 1 pulse per second and about 5,000 pulses per second. In some cases, the generator and / or emitter can be configured to emit laser energy having a wavelength between about 400 nanometers and about 800 nanometers, a pulse duration between about 1 femtosecond and about 1 second, and a frequency between about 1 pulse per second and about 5,000 pulses per second. In other cases, the generator and / or emitter can be configured to emit laser energy having a wavelength between about 800 nanometers and about 3,000 nanometers, a pulse duration between about 1 femtosecond and about 1 second, and a frequency between about 1 pulse per second and about 5,000 pulses per second. In other cases, the generator and / or emitter can be configured to emit laser energy having a wavelength between about 3,000 nanometers and about 12,000 nanometers, a pulse duration between about 1 femtosecond and about 1 second, and a frequency between about 1 pulse per second and about 5,000 pulses per second. In other cases, the generator and / or emitter can be configured to emit laser energy having a wavelength between about 300 nanometers and about 360 nanometers, a pulse duration between about 1 femtosecond and about 1 second, and a frequency between about 1 pulse per second and about 5,000 pulses per second.

[0135] The degree of force generated by the laser-induced pressure wave can be modulated by using lasers that produce laser energy at different wavelengths and different pulse durations, as would be understood by one of ordinary skill in the art based on the present disclosure. For example, breaking a vessel occlusion can require a different degree of force than is required to deliver a therapeutic agent to vessel tissue. In some embodiments, a laser having a holmium source (referred to as a holmium laser) can emit laser energy having a wavelength of about 2,100 nanometers (nm) and can be coupled with various light-absorbing materials, including water-based or salt-based media, to treat vessel occlusions in a subject.

[0136] Other sources of laser light energy can be paired with corresponding light absorbing materials to generate laser-induced pressure waves to treat vascular occlusions. For example, YAG crystal lasers can produce infrared wavelengths of light that are highly absorbable in aqueous solutions. Aqueous solutions can be used as light absorbing materials or media to generate laser-induced pressure waves. Aqueous solutions include, but are not limited to, normal saline, dextrose, radiopaque contrast agents, lactated Ringer's solution, and electrolyte solutions. In some cases, the YAG wavelength can be doubled to generate light in the visible spectrum at a wavelength of 532 nm. Materials or media capable of absorbing light at this wavelength include, but are not limited to, gold nanospheres, nitrite solutions, potassium permanganate solutions, copper salts, aluminum solutions, aluminon, ammonia salts, and dyes such as hematoxylin and propidium iodide. Light absorbing materials like these can be part of a solution, such as the aqueous solutions described above, and / or they can be applied as a coating on various surfaces within the device.

[0137] In some embodiments, a YAG holmium laser can emit laser light energy at a wavelength of about 2,120 nm and can be coupled with various light absorbing materials, including aqueous or saline-based media, to treat vascular occlusions in a subject. In some embodiments, a thulium laser, such as a YAG thulium laser, can emit laser light energy at a wavelength of about 2,013 nm and can be coupled with various light absorbing materials, including aqueous or saline-based media, to treat vascular occlusions in a subject. In some embodiments, a thulium laser, such as a thulium fiber laser, can emit laser light energy at a wavelength of about 1,908 nm and can be coupled with various light absorbing materials, including aqueous or saline-based media, to treat vascular occlusions in a subject. In some embodiments, a Nd-YAG laser can emit laser light energy at a wavelength of about 1,064 nm and can be coupled with various light absorbing materials to treat vascular occlusions in a subject. In some embodiments, a doubled YAG laser can emit laser light energy at a wavelength of about 532 nm and can be coupled with various light absorbing materials to treat vascular occlusions in a subject. In some embodiments, an alternative band YAG laser can emit laser light energy at a wavelength of about 1,319 nm and can be coupled with various light absorbing materials to treat vascular occlusions in a subject. In other embodiments, an Er-YAG laser can emit laser light energy at a wavelength of about 2,940 nm and can be coupled with various light absorbing materials to treat vascular occlusions in a subject.

[0138] Carbon dioxide (CO2) lasers can emit infrared light, which is highly absorbent in aqueous solutions. CO2 lasers are common surgical lasers and are highly absorbent in tissue due to the high water content of tissue. Light absorbing materials that can be coupled with a CO2 laser that emits infrared light, such as light emitted at a wavelength of 10.6 microns, to generate laser-induced pressure waves include, but are not limited to, aqueous solutions such as normal saline, dextrose, radiopaque contrast agents, lactated Ringer's solution, and electrolyte solutions.

[0139] Nitrogen lasers can be used to produce low frequency, high energy laser pulses. Nitrogen lasers can emit light within the UV spectrum, can emit laser light energy at a wavelength of about 337 nm, and can be coupled with various light absorbing materials to generate laser-induced pressure waves, including but not limited to radiopaque contrast agents and metals and oxides such as aluminum, silver, gold, copper, nickel, cerium, zinc, titanium, and dyes such as hydroxycoumarin and aminocoumarin.

[0140] Other medically useful lasers that can be used to generate laser-induced pressure waves to treat vascular occlusions include Ti-sapphire lasers, which can emit laser light energy at a wavelength of about 800 nm, ruby lasers, which can emit laser light energy at a wavelength of about 694 nm, and Alexandrite lasers, which can emit laser light energy at a wavelength of about 755 nm. These medical lasers emit laser light energy within the near infrared spectrum and can be used for the generation of laser-induced pressure waves. Light absorbing materials or media that can be coupled with these lasers include, but are not limited to, dyes and colorants, which can be used in solutions, suspensions, or coatings on another material or surface within a device. Various materials capable of absorbing laser light energy at these wavelengths include aqueous copper, copper salts, and copper sulfate, as well as materials such as fluorophores used in fluorescence microscopy (e.g., methylene blue).

[0141] Dye lasers can also be used to generate laser-induced pressure waves to treat vascular occlusions. In some cases, dye lasers can be tuned to output light at a specific wavelength within the visible spectrum, which can allow the laser to be optimized for a certain light absorbing material, as an alternative or in addition to using a material that has a high absorbance for light at a specific wavelength. In this way, the light absorbing material can be any of the materials mentioned previously, as well as dyes, colorants, and visible light chromophores.

[0142] For some applications, it can be desirable to increase the number and / or size of the bubbles generated with the laser-induced pressure wave generated by the emission of laser energy into the corresponding light-absorbing liquid medium. For example, when entering a blood vessel of small diameter size, the size of the catheter can be limited. In some cases, the force exerted by the bubble on the tissue (e.g., a vascular occlusion) can be proportional to the size of the individual bubble generated, as the bubble expands and collapses after the laser light energy is emitted into the liquid medium and generates a pressure wave. That is, in the case of using a liquid medium that is not saturated with a gaseous substance, the strength of the initial laser-induced pressure wave and / or the size of the bubble can be limited. One way to increase the size of the individual bubble (e.g., to exert a greater force on a particular tissue) is to saturate the liquid medium with a gaseous substance such that the gas in the liquid medium exhibits a higher vapor pressure than a liquid medium without such a gas. Suitable gaseous substances that can be used to create a gas-saturated liquid medium include, but are not limited to, ambient air, carbon dioxide, iodine gas, oxygen, nitrogen, compressed air, nitrous oxide, and combinations of these.

[0143] The higher vapor pressure of the gaseous substance added to the liquid medium will result in the gaseous substance returning to the gaseous state more quickly (at smaller pressure fluctuations) than the liquid medium. In other words, less pressure is required to bring the saturated gaseous substance out of solution, resulting in the creation of larger bubbles, which in turn results in greater force. In some cases, the use of a gas-saturated liquid medium allows for the use of laser light energy at reduced intensity, or reduced pulse or pulse duration, without a concomitant reduction in the total force generated by the bubbles (as each bubble is larger). This can improve the safety and effectiveness of the procedure being performed.

[0144] The gaseous substance can be applied to the liquid medium in various ways, including under pressure, by mechanical agitation, and / or by blowing the gas into the liquid medium. In some cases, the gas-saturated liquid medium can be prepared prior to the procedure and then delivered to the distal end of the catheter prior to performing the procedure. Additionally or alternatively, the gaseous substance can be delivered into the liquid medium already present in the catheter.

[0145] Gases and / or gaseous substances can be dissolved and quantified by the amount of gas present in 1 kg of liquid medium. The maximum amount of gas that can be dissolved in a liquid medium depends on the solubility of the particular gas in that liquid medium, the pressure, and the temperature, as described by Henry's law of gas solubility. For example, carbon dioxide can be dissolved in water at 30 degrees Celsius at atmospheric pressure at a concentration of 1.25 g / kg water or less. Also, when carbon dioxide is dissolved in water or saline, a total concentration of 0.25-3.5 g / kg H2O is produced. Other dissolved gases have the following concentrations in 1 kg of liquid medium: iodine gas is 1 mg-1 g / kg, oxygen is 5-80 mg / kg, nitrogen is 5-40 mg / kg, room air is 5-500 mg / kg, and nitrous oxide is 0.1-4 g / kg.

[0146] Gases and / or gaseous substances can be dissolved in amounts that exceed the theoretical limit, which is referred to as supersaturation. As previously described, the theoretical limit is described by Henry's law. By dissolving a gas at increased pressure or reduced temperature, and then returning it to normal atmospheric conditions, it is possible to dissolve larger amounts of gas than would be possible at atmospheric conditions. For example, 2.5 g of carbon dioxide can be dissolved in water at 30 degrees Celsius at 2 atmospheres of pressure, and then returned to atmospheric pressure. For any dissolved gas, the percent saturation is defined by the concentration of the gas divided by the maximum concentration possible by theory. For any of the gases in the supersaturated solutions mentioned previously, the percent saturation can range from 100-300%.

[0147] The use of a gas-saturated liquid medium or a supersaturated liquid medium can also increase the initial laser-induced pressure wave caused by the interaction of the laser and the liquid medium. That is, a gas-saturated liquid medium or a supersaturated liquid medium can contain more potential energy, which when activated by a laser, can produce a larger initial laser-induced pressure wave than would be produced by the interaction of a laser and a non-gas-saturated liquid medium.

[0148] Additionally or alternatively, the methods of the present disclosure further include activating at least one proximal laser emitter encased within the sheath assembly to transmit a pulse of laser light energy through the liquid medium and propagate a laser-induced pressure wave to assist in stent deployment. The pressure wave generated by the bubble can help the stent to be seated or expanded to its full diameter as part of the medical procedure.

[0149] As described above, activation of one or more emitters and transmission of pulses of light energy into a liquid medium can generate vapor bubbles. When light is emitted from an emitter (e.g., a laser catheter) within a sheath containing an absorptive liquid medium, vapor bubbles can be generated inside the sheath and / or outside the sheath. Assuming that the vapor bubbles are generated inside the sheath, it can be desirable to limit the potential expansion of some or all of the relevant portion of the sheath caused by the vapor bubbles. That is, it can be desirable to reduce or prevent the ability of the sheath to expand and contract when vapor bubbles are generated therein, in order to reduce or prevent the sheath from exerting hydraulic or pressure forces on the vessel occlusion and / or the vessel wall. Also, assuming that the vapor bubbles are generated outside the sheath that is positioned within the vessel wall, it can be desirable to reduce and / or prevent the formation of such vapor bubbles, in order to reduce or prevent the exertion of hydraulic or pressure forces on the vessel occlusion and / or the vessel wall by the cavitation events and vapor bubbles themselves.

[0150] Reference is made to FIG. 5 FIG. 22 illustrates a perspective view of a biocompatible sheath 250" that can be used in conjunction with a laser catheter or any of the previous embodiments to perform methods of treating a subject, such as removing or treating a vessel occlusion. The sheath 250" can include a sleeve or cannula 522" and an attenuation member 524". FIG. 5 The attenuation member 524" is shown as being exposed and coupled with the distal end of the sleeve 522" by an adhesive. However, the attenuation member 524" can alternatively be integrally disposed within the sleeve 522", disposed on the exterior of the sleeve 522", and / or disposed on the interior of the sleeve 522". Furthermore, if the attenuation member 524" is coupled with the distal end of the sleeve 522", or the attenuation member 524" is integrally disposed within or on the interior of the sleeve 522", the entire attenuation member 524" can be covered (not exposed) by the sleeve 522", the entire attenuation member 524" can be exposed, or a portion (e.g., a distal portion) of the attenuation member 524" can be exposed and another portion (e.g., a proximal portion) can be covered.

[0151] FIG. 5 The attenuation member 524" is also shown as being disposed at the distal end of the sheath 250". However, the attenuation member 524" can alternatively and / or additionally be disposed at the proximal end of the sheath 250", at a central portion of the sheath 250", at any location or locations between the proximal and distal ends of the sheath 250", or along the entire length or substantially the entire length of the sheath 250".

[0152] The dampening member 524" has two purposes. One purpose is to reinforce the sleeve 522" and / or the sheath 250", and the other purpose is to reduce or prevent the possible formation of vapor bubbles outside of the dampening member 524", the sleeve 522", and / or the sheath 250". With respect to reinforcing the sleeve 522", coupling the dampening member 524" with the sleeve 522" can reduce or prevent the ability of the sheath to expand and contract when vapor bubbles are created therein, thereby reducing or preventing the sleeve 522" from exerting hydraulic or pressure forces against the vessel occlusion and / or the vessel wall. Reinforcing the sleeve 522" can minimize and / or prevent the sleeve from bulging, splitting, or delaminating (in the case where the sleeve includes multiple layers), and minimize and / or prevent the formation of holes within the sleeve. When one or more of these situations occur, the difficulty of subsequently translating the sleeve through the patient's vessel and / or relative to the translation of the laser catheter can increase.

[0153] The dampening member 524" and the sleeve 522" are both constructed of biocompatible materials. Coupling the dampening member 524" with the sleeve 522" within the sheath 250" creates a rigid or semi-rigid structure such that little or no hydraulic pressure is exerted against the vessel occlusion and / or the vessel wall when vapor bubbles are created therein. It can be desirable that the majority or only force exerted against the vessel occlusion and / or the vessel wall be the result of the laser-induced pressure waves passing through the sheath 250", thereby allowing for more precise control of the laser-induced pressure waves.

[0154] With respect to another purpose of the dampening member 524", it is to reduce or prevent the formation of vapor bubbles outside of the dampening member 524", the sleeve 522", and / or the sheath 250", and continuing with reference to FIG. 5The openings 526" within the attenuating member 524" can prevent the formation and propagation of vapor bubbles on the sheath 250". The openings 526" not only allow the laser-induced pressure waves to pass through, but the number and size of the openings 526", particularly relative to the rest of the structure of the sleeve 522" (or portion 528" thereof), can also limit the size of vapor bubbles that can form outside of the sheath 250". The relationship between the open area and the closed area (or the ratio of the open area to the total area) within the attenuating member 524" should be such that a sufficient amount of the laser-induced pressure waves pass through the attenuating member 524". Also, the size of the openings 526" should allow the laser-induced pressure waves to pass therethrough while also limiting the size of vapor bubbles that can form outside of the sheath 250". Thus, it can be desirable for the ratio of the open area to the total area of the attenuating member 524" to be between 1% and 99%, including any increments therebetween, such as 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%,..., 15%..., 20%,..., 25%,..., 30%,..., 35%,..., 40%,..., 45%,..., 50%,..., 55%,..., 60%,..., 65%,..., 70%,..., 75%,..., 80%,..., 85%,..., 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, and 98%. It can also be desirable for the ratio of the open area to the total area of the attenuating member 524" to be within a particular range, such as between 5% and 95%, 10% and 90%, 15% and 85%, 20% and 80%, 25% and 75%, 30% and 70%, 35% and 65%, 40% and 60%, 45% and 55%.Further, for any of the above ratios, it can be desirable for each opening to have a particular size, such as between 10 microns and 10,000 microns (1 millimeter), including any increments therebetween, such as 10 microns,..., 12.5 microns,..., 15 microns, 17.5 microns,..., 20 microns,..., 30 microns,..., 40 microns,..., 50 microns,..., 75 microns,..., 100 microns,..., 125 microns,..., 150 microns, 175 microns,..., 200 microns,..., 300 microns,..., 400 microns,..., 500 microns,..., 600 microns,..., 700 microns,..., 800 microns,..., 900 microns,..., 1000 microns,..., 2000 microns,..., 3000 microns,..., 4000 microns,..., 5000 microns,..., 6000 microns,..., 7000 microns,..., 8000 microns,..., 9000 microns,..., 9100 microns,..., 9200 microns,..., 9300 microns,..., 9400 microns,..., 9500 microns,..., 9600 microns,..., 9700 microns,..., 9800 microns,..., 9900 microns,..., and 10000 microns. It can also be desirable for the openings 526" within the dampening member 524" to have a size within a particular range, such as between 1000 and 9000 microns, 2000 and 8000 microns, 3000 and 7000 microns, 4000 and 6000 microns, and 4500 and 5500 microns.

[0155] The dampening member's ability to reduce or prevent the formation of vapor bubbles on the outside of the dampening member 524", the sleeve 522", and / or the sheath 250" potentially reduces the presence and / or size of vapor bubbles formed on the outside of the dampening member 524", the sleeve 522", and / or the sheath 250", which in turn reduces the likelihood of vapor bubbles being created and expanding and contracting between the dampening member 524", the sleeve 522", and / or the sheath 250" and the vessel wall. Moreover, reducing or preventing the expansion and contraction of vapor bubbles between the sleeve 522", and / or the sheath 250" and the vessel wall can prevent or reduce the likelihood that hydraulic or pressure forces will be exerted onto the vessel occlusion and / or the vessel wall, thereby preventing and / or minimizing potential damage to the vessel itself.

[0156] With respect to the ability of the reinforcing sleeve 522" and / or the sheath 250" to dampen the dampening member 524", the dampening member 524" can reduce or prevent the ability of the sleeve and / or the sheath to expand and contract when vapor bubbles are created therein. Reducing the ability of the sleeve and / or the sheath to expand and contract when vapor bubbles are created therein can reduce or prevent the sleeve 522" and / or the sheath 250" from exerting hydraulic or pressure forces onto the vessel occlusion, the restriction, and / or the vessel wall.

[0157] FIG. 5 The openings 526" in the attenuation member 524" illustrated in FIG. 28 are shown as hexagons, which are disposed around the perimeter of the attenuation member 524" and along its length. Although the openings 526" in the attenuation member 524" are shown as hexagons, the openings can have alternative shapes, such as circles, ovals, triangles, squares, rectangles, spiral shapes, polygons, diamonds, pentagons, heptagons, octagons, nonagons, and decagons. For example, FIG. 5A a side view of an attenuation member 524" including a plurality of square openings is shown; FIG. 5B is a side view of an attenuation member 524" including a plurality of diamond-shaped openings, FIG. 5C is a side view of an attenuation member 524" including a plurality of openings formed by a spiral-shaped structure that is wound in a particular direction (e.g., clockwise or left-to-right), and FIG. 5D is a side view of an attenuation member 524" including a plurality of openings formed by a spiral-shaped structure that is wound in an alternative direction (e.g., counterclockwise or right-to-left). Moreover, two spiral-shaped attenuation members 524" can be combined to form FIG. 5E an attenuation member 524" illustrated in FIG. 28. FIG. 5E an attenuation member 524" illustrated in FIG. 28 is similar to FIG. 5B an attenuation member 524" illustrated in FIG. 28, but FIG. 5B an attenuation member 524" illustrated in FIG. 28 is woven, and FIG. 5E an attenuation member 524" illustrated in FIG. 28 is wound or formed from one or two hypotubes. Moreover, FIG. 5E the structure (or portions thereof) of the attenuation member 524" illustrated in FIG. 28 is larger than FIG. 5B the structure (or portions 528" thereof) of the attenuation member 524" illustrated in FIG. 28 is larger because the size of the woven material is generally smaller. Referring to FIG. 5F the structure (or portions thereof) of the attenuation member 524" illustrated in FIG. 28 is comparable in size to the hexagonal openings.

[0158] Referring to FIG. 6 the treatment of a subject using the laser catheter 170 (illustrated in FIG. 27) and the sheath 250" (illustrated in FIG. 28), and / or the use of the laser catheter 170 in combination with the sheath 250" to ablate a vascular occlusion and / or to generate laser-induced pressure waves in the presence of a liquid medium and to disrupt a portion of the vascular occlusion (as illustrated in FIG. 29). FIG. 2 FIG. 5 FIGS. 3A-3D ​​A representative flowchart of the method 600 is illustrated in FIG. 6. The method 600 can include the step 605 of positioning a guidewire 210 within a vessel 185 of a subject, the step 610 of positioning a laser catheter 170 over the guidewire 210 positioned within the vessel 185, the step 615 of positioning a sheath 250" over the laser catheter 170 positioned within the vessel, and the step 620 of positioning the sheath 250" and the laser catheter 170 (and optionally the guidewire 210) adjacent to a vessel occlusion positioned within the vessel 185 of the subject. Again referring to FIG. 3A Positioning the sheath 250 and the laser catheter 170 adjacent to the vessel occlusion 175 creates a chamber for the liquid medium to accumulate distal to the distal end of the laser catheter 170, and in particular, distal to the emitter / fiber of the laser catheter 170.

[0159] FIG. 3A The distal end of the laser catheter 170 is illustrated as being positioned proximal to the distal end of the sheath 250. However, it is contemplated that the distal end of the laser catheter 170 can be disposed at or distal to the distal end of the sheath 250, so long as there is liquid medium between the emitter / fiber of the laser catheter 170 and the vessel occlusion 175. The axial position of the laser catheter 170 and the sheath 250 can be adjusted by translating one or both of the components relative to each other. In order to visualize the respective positions of the laser catheter 170 and the sheath 250 under fluoroscopy, the laser catheter 170 and the sheath 250 can include radiopaque markers at any respective positions along their lengths.

[0160] Continuing to refer to FIG. 3A Once the sheath 250 and the laser catheter 170 are disposed adjacent to the vessel occlusion 175, the liquid medium can be introduced to the distal end of the laser catheter as described in step 625 of FIG. 6 Continuing to refer to FIG. 6 Step 630 includes activating the laser to generate a laser-induced pressure wave in the presence of the liquid medium and to disrupt a portion of the vessel occlusion, and in particular, the calcified cap of the vessel occlusion. The laser catheter 170 and the sheath 250 can be used to traverse the entire vessel occlusion 175 as described in step 640 of FIG. 6 (and optionally step 635 of FIG. 6 If the laser catheter 170 and the sheath 250 are only used to disrupt a portion of the vessel occlusion 175, then the guidewire 210 can penetrate and traverse the vessel occlusion 175. For example, FIG. 3B The guidewire 210 is illustrated penetrating and traversing the vessel occlusion 175'.

[0161] Referring to FIG. 3C, assuming the laser catheter 170 and sheath 250 are only used to disrupt a portion of the vessel occlusion 175", the laser catheter 250 can be used to cross the vessel occlusion 175" without the sheath 250. Referring to step 645 of FIG. 6 , the insertion of the liquid medium can cease and, as the laser catheter 170 is passed over the guidewire 210 through the vessel occlusion 175", the laser catheter 170 can be used to ablate the vessel occlusion while the sheath 250 remains proximal of the vessel occlusion.

[0162] Referring to step 650 of FIG. 6 , once the entire vessel occlusion has been crossed by the laser catheter 170, the opening created by the laser catheter 170 should be large enough for the sheath 250 to be translated distally and through the vessel occlusion. At this point, the distal end of the sheath 250 and the distal end of the laser catheter 170 should be located distal of the vessel occlusion. At this point, referring to FIG. 3D , the laser catheter 170 can be translated proximally while the sheath 250 remains stationary within the vessel occlusion. While the liquid medium is introduced into the sheath 250 in front of the laser catheter 170, the laser can be activated to create a laser-induced pressure wave in the presence of the liquid medium. At least a portion of the laser-induced pressure wave is directed radially and, as the laser catheter 170 is translated proximally within the sheath 250, the laser-induced pressure wave is transmitted through the sheath 250 and / or the sheath 250 itself expands and contracts, thereby disrupting the remaining portion of the vessel occlusion 175".

[0163] To ensure that a majority of the remaining portion of the vessel occlusion 175' is disrupted, and if desired, the intimal layer and / or the tissue of the vessel and the vessel occlusion, the laser catheter 170 can be repeatedly translated distally and proximally within the sheath 250. As discussed above, disrupting the intimal layer and / or the tissue of the vessel and the vessel occlusion can improve the ability of the vessel to absorb a drug, especially when such a drug is applied with a drug eluting balloon. Additionally, it is contemplated that any of the steps of the process outlined in FIG. 6 may be used to ablate a portion of the vessel occlusion alone, or the laser catheter 170 can be used in conjunction with the sheath 250, before, during, and / or after any of the steps of the process.

[0164] As described above, the transmission of pulses of optical energy from the emitter into the liquid medium produces laser-induced pressure waves and / or bubbles and cavitation events, which in turn produce additional pressure waves that at least disrupt a portion of the vessel occlusion. The catheter can include a guidewire lumen through which a guidewire can be passed and through the vessel occlusion. It can also be desirable to excite and vibrate the guidewire to increase the ability of the guidewire to pierce and pass through the vessel occlusion. Accordingly, the present disclosure also contemplates introducing laser light energy emitted by the emitter into the liquid medium in a direction that causes the liquid medium to propagate pressure waves toward the guidewire lumen and / or the guidewire, such that the pressure waves excite and vibrate the guidewire.

[0165] In some embodiments, the devices and methods of the present disclosure can also be used to transmit laser-induced pressure waves to ablate a vessel occlusion using a substantially solid light-absorbing material instead of a liquid medium. In some cases, pairing a laser that emits light of a particular wavelength with a light-absorbing material designed to absorb light of that wavelength can significantly improve the energy efficiency of the resulting laser-induced pressure waves. Using such pairings can ultimately reduce the energy input needed to treat a vessel occlusion, which can improve the safety of the procedure and reduce costs. For example, a catheter according to embodiments of the present disclosure can be filled with air or a substantially inert liquid medium, such as saline, instead of a contrast medium, which can significantly reduce the number and size of bubbles produced with the laser-induced pressure waves. Because the laser-induced pressure waves can propagate outside of the catheter to ablate the vessel occlusion, in some cases it is advantageous to reduce (e.g., fill the catheter with saline) or eliminate (e.g., fill the catheter with air or an inert gas) the production of bubbles. In other cases, the liquid medium delivered to the distal end of the catheter can be pre-treated to remove the amount of gas dissolved therein using methods known to those of ordinary skill in the art based on the present disclosure, as this can also reduce the amount of bubbles produced with the laser-induced pressure waves.

[0166] Suitable light-absorbing materials can be any formulation capable of absorbing light energy and generating laser-induced pressure waves. For example, light-absorbing materials can contain iodine-bound aromatic hydrocarbons, such as iodinated X-ray contrast agents. Low-osmotic, nonionic, iodinated, and radiopaque contrast agents are also suitable light-absorbing materials and can be used to generate laser-induced pressure waves. Other light-absorbing materials include, but are not limited to: iodinated contrast agents, such as diatrizoate, mesylate, lodamiamine, lotalamine, loxitamine, loglicic acid, kojic acid, locametic acid, methylthioacetal, diiodophenone, metrizamide, lohexol, loxaglic acid, loparadol, loproamide, lotolan, loperamide, lopentol, lodixanol, lomepre Lopelido, Loxilan, Lodoxamine, Lotocilactenol, Loxylglycine, Hexadiiodone, Lobenzoic acid, Lopacic acid, Loxitamic acid, Sodium iodide, Tyrosine, Calcium iodide, Lopidochlor, Propiodone, Isofen ester, Iodized oil, Non-iodinated contrast agents such as barium sulfate, MRI contrast agents such as gadobenzene, gadobutrol, gadodiamine, gadophosphine, gadolinium, gadopentetate, gadoteric acid, gadoterol, gadovitylamine, gadoxetine, citric acid Ferric ammonium, Mangafodipir, Ferumoxsil, and Ferristene iron oxide nanoparticles, Perflubron, glucose and other carbohydrates, albumin and other proteins, nitroglycerin or other vasodilators, hydrocarbons such as oils, alcohols, or other organic functional groups (amines, alkanes, carboxyl groups, etc.), blood / tissue products such as platelet-rich plasma (PRP), concentrated red blood cells, plasma, platelets, fat, charcoal, biocompatible materials such as stainless steel, biopolymers, and bioceramics, or other pharmaceutical agents containing a combination of aromatic carbocyclic rings and functional groups, such as salicylic acid, acetylsalicylic acid, methyl salicylate, mesalazine, aspirin, acetaminophen, ibuprofen, clopidogrel, or other drugs and / or biological agents that may be compatible with the medical procedures described herein.

[0167] Suitable light absorbing materials can also include those materials capable of absorbing wavelengths in the UV spectrum. For example, the light absorbing material can include, but is not limited to, PABA, Padimate 0, Phenylbenzimidazole Sulfonic Acid, Cinoxate, Dioxybenzone, Oxybenzone, Homosalate, Methyl Anthranilate, Octocrylene, Octyl Methoxy Cinnamate, Octyl Salicylate, Sulisbenzone, Trolamine Salicylate, Avobenzone, Ecamsule, 4-Methylbenzylidene camphor, Tinosorb M, Tinosorb S, Tinosorb A2B, Neo Heliopan AP, Mexoryl XL, Benzophenone-9, Uvinul T 150, Uvinul A Plus, Uvasorb HEB, Parsol SLX, or Amiloxate, silicon and its various atomic structures, cadmium telluride, copper indium gallium selenide, gallium arsenide, ruthenium metallo-organic dyes, polyphenylene vinylene, copper phthalocyanine, carbon fullerenes and derivatives, carbon compounds (e.g., graphite, graphene, diamond, charcoal), titanium and oxides, nickel and oxides, gold, silver, zinc and oxides, tin and oxides, aluminum and oxides, or alloys or ceramics of the foregoing metals.

[0168] The light absorbing material can be combined with various other compounds to facilitate its attachment to the substrate. For example, the light absorbing material can be combined with various compounds (e.g., solubilizing agents) that aid in the creation of a solution or mixture containing the light absorbing material that can be used to coat the substrate. In some embodiments, a biodegradable and biocompatible hydrophobic polymer can be used as the light absorbing material. For example, the biodegradable and biocompatible hydrophobic polymer can be poly(glycerol sebacate) (PGSA) or variants and combinations thereof, which can be crosslinked with ultraviolet light. The ultraviolet light can be emitted from the distal end of a catheter that can be disposed within or outside of a sheath to activate, for example, the PGSA.

[0169] Other light absorbing materials can also include formulations having similar adhesive properties, and in some cases, the light absorbing properties of these formulations can be outside of, or independent of, their use as an adhesive. For example, light absorbing materials can include, but are not limited to, cyanoacrylate, bovine serum albumin (BSA)-glutaraldehyde, fibrin sealant, gelatin matrix thrombin, gelatin sponge, oxidized cellulose, collagen sponge, collagen fleece, recombinant factor Vila, and the like. In some embodiments, light absorbing materials can include hydrophobic functional groups such as hexanoyl (Hx; C6), palmitoyl (Pam; C16), stearoyl (Ste; C18), and oleoyl (Ole; C18 unsaturated) groups in order to resist being washed away or dislodged from their substrate in a water- dominant environment such as vasculature. Such light absorbing materials can include, but are not limited to, 10Ole- disuccinimidyl tartrate, 10Ste-disuccinimidyl, and variations and combinations thereof.

[0170] The light absorbing material can be configured to exhibit high absorption of light energy from the emitter. The light energy can be emitted at any suitable wavelength capable of generating a laser-induced pressure wave. The light energy can be emitted between about 1 nanometer and about 1 millimeter. In some cases, the light can be emitted from about 10 nanometers to about 5000 nanometers. In some cases, the light can be emitted from about 100 nanometers to about 1000 nanometers. In some cases, the light can be emitted from about 250 nanometers to about 750 nanometers.

[0171] In some cases, the light can be emitted from about 300 nanometers to about 600 nanometers. In other cases, the light can be emitted from about 300 nanometers to about 350 nanometers.

[0172] In general, the light absorbing material can be disposed anywhere within the catheter so long as it substantially intersects the path of light emitted from the optical fiber. In some embodiments, the light absorbing material can be substantially solid (e.g., stabilized in a general solid state such as metals and metal alloys). The substantially solid light absorbing material can be used to construct various portions of a component of the catheter, and / or the substantially solid light absorbing material can be used to construct a separate structure independent of another catheter component.

[0173] In some embodiments, the light-absorbing material may be applied to a separate support structure (i.e., a support structure not primarily made of the light-absorbing material, or not used as a light-absorbing material support structure) and used to generate laser-induced pressure waves using the apparatus and methods of this disclosure. In some embodiments, the light-absorbing material is stable only in liquid, gel, or semi-liquid form. In these embodiments, the light-absorbing material may be included as part of a formulation or coating suitable for application to the support structure, such as impregnation in a hydrogel or other solid support matrix. In some embodiments, the light-absorbing material may be part of a formulation or coating containing other agents that facilitate their placement and / or adhesion on the support structure. For example, the solid absorbing material may be formulated with coating agents, thickeners, adhesives, and / or other pharmaceutical or biological agents suitable for use with the apparatus and methods of this disclosure.

[0174] As stated above, this disclosure discusses the use of laser conduit 170 (in... FIG. 2 (as shown in the drawing) and sheath 250″ (in FIG. 5 (Illustrated in the figure) Before generating a laser-induced pressure wave in the presence of a liquid medium and destroying a portion of the vascular occlusion, the laser catheter 170 is used to ablate at least a portion of the vascular occlusion or restriction in the subject's blood vessels. FIGS. 7-8F Included to illustrate the formation of vascular occlusions within the blood vessels of a subject treated with laser catheter 170 and sheath 250. Reference FIG. 7 The diagram shows a cross-sectional view of a healthy arterial wall 700 taken along a direction perpendicular to the longitudinal axis of the arterial wall. The healthy arterial wall 700, or vascular wall, typically includes an outer layer called the "adventitia" or "arterial adventitia," which... FIG. 7 The adventitia is shown as layer 720. Further layers of the arterial wall 700, such as layer 710, may exist lateral to the adventitia. A healthy arterial wall 700 also includes an intermediate or central layer called the media 730. The media 730 is located radially medial to the adventitia 720 and adjacent to the inner portion of the adventitia 720. The media 730 has a layer of smooth muscle cells and a layer of elastic fibers, which allows the artery to expand and contract. A healthy arterial wall 700 also includes an inner layer called the intima 740. The intima 740 is located radially medial to the media 730 and adjacent to the media 730. A healthy arterial wall 700 also includes an endothelial layer 750, which lies on the innermost surface of the intima 740 and forms the boundary of the channel (or internal lumen) 760.

[0175] As noted above, the media 730 is located radially inward of and adjacent to the inner portion of the adventitia 720. Specifically, an outer elastic membrane 735, often referred to as an outer elastic layer, separates the media 730 from the adventitia 720. As noted above, the intima 740 is located radially inward of and adjacent to the inner portion of the media 730. An inner elastic membrane 725, often referred to as an inner elastic layer, separates the intima 740 from the media 730.

[0176] Referring to FIG. 7A , a smaller version of the structure of the healthy arterial wall 700 is illustrated. FIG. 7 Moreover, FIG. 8A is a longitudinal cross-sectional view of the healthy arterial wall 700 taken in a direction parallel to the longitudinal axis of the arterial wall. Specifically, FIG. 8A is a longitudinal cross-sectional view of the structure of the healthy arterial wall 700 taken along line B-B of FIG. 7A

[0177] Referring to FIG. 8B , over time, due to the accumulation of fat and lipids in the blood, fat and / or lipids 770' can begin to collect and / or deposit in the intima 740' of the arterial wall 700. This disease process is commonly referred to as atherosclerosis and occurs in the arteries of the body, including the coronary arteries and peripheral arteries. It is this collection of fat and / or lipids 770' in the intima 740' that will lead to the formation of a vascular occlusion that can reduce or completely block blood flow in the passageway 760'. Over time, this accumulation of fat and lipids 770" becomes a heterogeneous mixture 765" of many components, commonly referred to as a plaque, including but not limited to fat, lipids, fibrin, fibrocalcific plaque, calcium crystals, thrombus, etc. For example, a portion of the fat and / or lipids 770' can become plaque 765" and even calcified portions, which are shown as 755" in FIG. 8C

[0178] Referring to FIG. 8D , as the atherosclerotic disease progresses, and without treatment of the condition of the arterial wall 700"", the plaque 765"" (not shown) continues to collect and the intima 740"" continues to expand and reduce the cross-sectional area of the passageway 760"". However, when the intima 740 of the arterial wall 700"" reaches its limit to expand further, the intima 740 and endothelium can rupture 758 and release the plaque contents previously contained in the thickened lipid and expanded intimal leukocytes into the passageway 760, as shown in FIG. 8E ​​The platelets and fibrin collect within the passageway 760 of the artery wall 700, attempting to repair the breach, and thus form a vascular occlusion 780, which can have calcified portions 785, as shown in FIG. 8F The figure also shows that the formation of the vascular occlusion 780 further reduces the size of the passageway 760, and in some cases completely occludes flow.

[0179] Referring to FIG. 8D and FIG. 8G and FIG. 8H The laser catheter 170 can be used to de-bulk or remove the plaque accumulation 770 or a portion thereof contained within the intima behind the plaque accumulation or within the vascular occlusion 780 from the passageway of the artery wall 700. After de-bulking the plaque accumulation or occlusive disease, the combination of the laser catheter 170 and the sheath 250 of the present disclosure can be used to treat the remaining portion of the plaque accumulation 770 or vascular occlusion 780, particularly by creating laser-induced pressure waves to disrupt the calcified portions 785 shown in FIG. 8H and / or FIG. 8H to treat the condition of the artery wall 700 shown in FIG. 8I

[0180] FIG. 8I The figure shows the artery wall 700 with an enlarged passageway 760, with the majority of the plaque 770" or vascular occlusion 780 removed, and the calcified portion of the remaining portion of the vascular occlusion broken or modified along with the calcified portion of the intima 740, making it more amenable to dilation at lower atmospheric pressure. FIG. 7 、 FIG. 7A and FIGS. 8A-8I Similar numerical values are used, but different figures include different designations, such as'and " and combinations thereof, for numerical values due to changes occurring within the artery wall as the vascular occlusion is formed and treated, which are shown progressively from one figure to the next. For the purpose of brevity, some layers of the artery wall 700 are omitted in the discussion of particular figures, and numerical values for some items of the artery wall 700 are omitted in particular figures. However, it is to be understood that the layers of the artery wall 700 and the values formed therein are the same, even if omitted from FIG. 7 、 FIG. 7A and FIGS. 8A-8I

[0181] Referring to FIG. 9A and 9B a method 900 is shown by performing atherectomy and using a laser catheter 170 (shown in FIG. 5 in combination with a sheath 250 (shown in FIG. 2 ​​(Illustrated) This method 900 removes plaque buildup or occlusive disease by treating the remaining portion of a vascular occlusion within the intima by generating laser-induced pressure waves in the presence of a liquid medium and destroying a portion of the occlusion. This method 900 can be used to treat coronary arteries and / or peripheral arteries, including but not limited to arteries of the leg vessels, renal arteries, subclavian arteries, etc.

[0182] FIG. 9A and 9B Method 900 includes determining the location of a vascular occlusion in a subject's blood vessel at step 905. A subsequent step 910 is optional and includes placing a guidewire at the vascular occlusion and / or inserting a guidewire through or across the vascular occlusion. Step 915 includes performing plaque resection to remove the plaque or vascular occlusion or a portion thereof. One type of plaque resection device is an ablation catheter, such as the laser ablation catheter 170 discussed herein, which is capable of ablating at least a portion of the vascular occlusion, such as... FIG. 8G As illustrated in the diagram. Other types of ablation catheters include radiofrequency ablation catheters, microwave ablation catheters, and cryoablation catheters. Plaque resection devices other than ablation catheters, such as mechanical plaque resection devices, can also be used to remove vascular occlusions.

[0183] After the vascular occlusion (or a portion thereof) has been removed from the blood vessel, step 920 can then be performed. Step 920 includes positioning the sheath 250 of this disclosure onto the laser conduit 170 located within the blood vessel of the subject, as... FIG. 8H As illustrated, the next step is step 925, which includes positioning the sheath 250 and the laser conduit 170 adjacent to the vascular occlusion, as shown in the diagram. FIG. 8H As illustrated in the illustration. For example, if a clinician uses a catheter 170 with a guidewire lumen and a sheath 250, the catheter 170 can slide on the guidewire 210 and enter the blood vessel, and the sheath 250 subsequently slides on the catheter 170, which is then coupled to the sheath 250. Step 925 also includes positioning the sheath 250 and the laser catheter 170 adjacent to the blood vessel occlusion (or the remainder thereof). The axial position of the laser catheter 170 and the sheath 250 can be adjusted by translating one or both components relative to each other. Specifically, the sheath 250 can be adjusted from... FIG. 8H The position shown in the drawing (which indicates the distal end of the laser conduit 170 extending beyond the sheath 250) is translated to... FIG. 8H The axial positions of the laser conduit 170 and sheath 250 are shown in the figure, wherein the emitter of the laser conduit 170 is located within the attenuation member of the sheath 250 and is axially aligned with both the attenuation member and the remainder of the vascular occlusion, and the corresponding portions of the sheath and the attenuation member are adjacent to the vascular occlusion (or the remainder thereof).

[0184] Once the sheath 250 and laser guide 170 are positioned adjacent to the vascular occluder, such that the emitter and attenuation components are... FIG. 8H As illustrated in the diagram, axially aligned and adjacent to the vascular occlusion, a liquid medium can be introduced to the distal end of the laser conduit, such as... FIG. 9A and FIG. 9B As described in step 930. Continue to refer to... FIG. 9A and FIG. 9B Step 935 includes activating an energy source (such as a laser) to generate a laser-induced pressure wave in the presence of a liquid medium and to destroy a portion of the vascular occlusion. The laser conduit 170 and sheath 250 can be used to traverse the entire vascular occlusion or to destroy only a portion of it. That is, the laser conduit 170 and sheath 250 can be relative to one another (in... FIG. 8H and FIG. 8H The laser catheter 170 and sheath 250 are moved axially (between the positions shown) and / or together, while emitting laser-induced pressure waves to destroy a portion of the vascular occlusion. If the laser catheter 170 and sheath 250 are used to destroy a portion of the vascular occlusion, then the guidewire 210 can penetrate and pass through the vascular occlusion as described in step 940.

[0185] At least one energy source coupled to at least one transmitter of the laser conduit (enclosed by a sheath 250) is activated to emit and transmit laser energy pulses into and / or react with the liquid medium to generate a propagating laser-induced pressure wave and disrupt the remaining portion of the vascular occlusion. The disruption of the remaining portion of the vascular occlusion, particularly any calcified portions within the occlusion, creates cracks within the calcified portions and / or reduces their size because the laser-induced pressure wave disrupts the calcified portions, causing them to rupture and / or breaking down the size of the calcified particles, thereby reducing the adjoint area. In some cases, method 900 may include the additional step (not shown) of activating at least one energy source coupled to at least one transmitter enclosed within the sheath to emit and transmit laser energy pulses into and / or react with the liquid medium to generate a propagating laser-induced pressure wave, thereby delivering a therapeutic agent from the sheath to the remaining portion of the vascular occlusion and / or the vascular tissue adjacent to the obstruction or restriction.

[0186] One of the benefits of this disclosure is that FIG. 8H and FIG. 8H The catheter 170 and sheath 250 illustrated may optionally include attenuation members, such as those described above. FIG. 5 The attenuation member is shown in the 250″ sheath. Attenuation member 524″ or FIGS. 5A-5FThe alternatives illustrated in FIG. 25 can reduce or prevent bubble formation and / or stiffen the sheath 250" outside of the attenuating member, thereby minimizing or preventing expansion of the sheath. Stiffening the sheath and / or reducing or preventing bubble formation outside of the attenuating member (or sheath) reduces or prevents fluid displacement outwardly and inwardly to expand the arterial wall, while allowing the laser-induced pressure waves to penetrate the arterial wall and disrupt the plaque and / or calcified portions in the intima. That is, including the attenuating member, stiffening the sheath, reducing or preventing bubble formation outside of the attenuating member, potentially inhibits displacement of soft tissue within the arterial wall, and can reduce or prevent delamination of the layers of the arterial wall.

[0187] Referring again to FIG. 25 FIG. 9A and 9B After performing steps 935 (and possibly 940), step 945 can be performed. Step 945 includes continuing to insert the liquid medium into the gap between the combination of the laser catheter 170 and the sheath 250, thereby continuing to disrupt the plaque with the laser-induced pressure waves while the laser catheter 170 remains within the sheath 250 proximal of the distal end of the sheath 250. Alternatively, the insertion of the liquid medium can cease, and the laser catheter 170 can be used to ablate the plaque as the laser catheter 170 is passed over the guidewire 210 through the plaque, while the sheath 250 remains proximal of the plaque, as described in step 950. That is, the introduction of the liquid medium between the laser catheter 170 and the sheath 250 can terminate, and the laser catheter 170 can extend beyond the distal end of the sheath 250 so that the laser catheter 170 can perform additional atherectomy. After performing additional atherectomy, the distal end of the laser catheter 170 can be returned to a position within the distal end of the sheath 250, and the liquid medium can be supplied to the distal end of the laser catheter 170 within the sheath 250 again, thereby generating laser-induced pressure waves again to disrupt remaining portions of the plaque that were recently ablated by the laser catheter.

[0188] To ensure that a substantial portion of the remaining portion of the plaque is disrupted, and if desired, the tissue of the intima and / or the vessel and the plaque, the laser catheter 170 can be repeatedly translated distally and proximally within the sheath 250, as in step 945 and / or step 955. As described above, disrupting the tissue of the intima and / or the vessel and the plaque can improve the ability of the vessel to absorb drugs, especially when these drugs are applied with a drug-eluting balloon. Also, it is contemplated that the laser catheter 170 can be used alone to ablate a portion of the plaque before, during, and / or after any of the steps in the process outlined in FIG. 25, or the laser catheter 170 can be used in conjunction with the sheath 250. FIG. 6

[0189] ​As described above, transmitting a pulse of optical energy from the emitter into the liquid medium creates laser-induced pressure waves and / or bubbles and an additional resultant pressure wave that disrupts at least a portion of the vessel occlusion. The catheter can include a guidewire lumen through which a guidewire can be passed and through the vessel occlusion. It can also be desirable to energize and vibrate the guidewire to improve the ability of the guidewire to pierce and pass through the vessel occlusion. Accordingly, the present disclosure also contemplates directing the laser light energy emitted by the emitter into the liquid medium in a direction that causes the laser-induced pressure waves to propagate toward the guidewire lumen and / or the guidewire such that the laser-induced pressure waves energize and vibrate the guidewire.

[0190] Although the methods shown in FIG. 9A and FIG. 9B illustrate that steps 905-955 of method 900 are performed consecutively, any or all of the steps within method 900 can be performed in any order and / or in parallel with any other steps. For example, some steps can be performed without performing other steps. After completing step 935 and / or step 940, the combined laser catheter and sheath can optionally be repositioned within the vessel adjacent another portion thereof. Similarly, after completing step 935 and / or step 945, the emitter can optionally be repositioned within the sheath. The sheath can be repositioned within the vessel and / or the emitter can be repositioned within the sheath. The method 900 also includes ending the operation upon achieving a desired therapeutic result, or any of the steps 905-945 can need to be repeated as can be necessary in treating a subject having a vessel occlusion.

[0191] Further, a drug eluting (coated) balloon (DEB or DCB) catheter can be used to deliver a drug to the remaining portion of the vessel occlusion. Disrupting the remaining portion of the vessel occlusion with laser-induced pressure waves prior to utilizing the DEB can increase the effectiveness of the drug applied to the vessel occlusion because the laser-induced pressure waves disrupt the intimal layer within the vessel as well as the calcium formed in the tissue, thereby creating a path for the drug to enter the intima and tissue of the vessel and / or the vessel occlusion.

[0192] The present disclosure also contemplates using the laser-induced sheath in conjunction with a conventional angioplasty balloon and DEB. For example, a surgical procedure can include performing an atherectomy with the laser catheter, using the sheath in conjunction with the laser catheter to treat calcified portions of the vessel as described above in FIG. 9A and 9B , and then inserting an angioplasty balloon (or DEB) into the vessel adjacent the relevant portion of the vessel and expanding the angioplasty balloon to dilate the relevant portion of the vessel.

[0193] As described above, the laser-induced pressure waves generated by the laser catheter and sheath of the present disclosure not only disrupt the calcification in the intimal layer and / or the vessel occlusion, the laser-induced pressure waves generated by the catheter of the present disclosure can also disrupt calcified portions of the tissue within the vessel wall. That is, the laser-induced pressure waves can be used to break up or alter calcified tissue regardless of whether the vessel includes an occlusion. For example, patients with medial arterial calcification, also known as sclerosis, can potentially benefit from treatment using the catheter of the present disclosure.

[0194] Referring to FIG. 10A , a healthy arterial wall 1000 is illustrated that is similar to the arterial wall illustrated in FIG. 8A . For example, FIG. 8A the reference numerals 710, 720, 730, 740, 750, and 760 correspond to the reference numerals 1010, 1020, 1030, 1040, 1050, and 1060 of FIG. 10A . That is, the reference numerals 1010 and 1020 are the adventitia, the reference numeral 1030 is the media, the reference numeral 1040 is the intima, the reference numeral 1050 is the endothelium, and the reference numeral 1060 is the lumen.

[0195] Referring to FIG. 10B , a cross-sectional view of an arterial wall 1000' is illustrated that includes a calcification deposit 1070 formed in the media 1030. The calcification deposit begins as a crystal aggregation and typically collects along the elastin layer within the media. As sclerosis, commonly referred to as medial calcification, develops, multiple layers of calcification can form, involving the entire circumference of the vessel. The calcification can also extend radially to the adventitial and intimal layers. Sclerosis (medial calcification) is caused by smooth muscle cells taking up the calcification and is attributed to, but not limited to, common comorbidities found in patients experiencing vascular disease, including diabetic, renal patients, and other metabolic or hormonal imbalances. The media 1030 includes smooth muscle cells and elastin that enable the artery to expand and contract. However, after the formation of the calcification deposit 1070, the ability of the artery to expand and contract is reduced. That is, the calcification deposit 1070 formed in the media 1030 reduces the compliance of the artery 1000', which in turn potentially reduces blood flow through such an artery and can potentially have a negative impact on other health conditions, such as diabetes. This condition can occur in conjunction with the atherosclerotic disease described previously or be an isolated condition without narrowing of the arterial lumen.

[0196] The combined catheter 170 and sheath 250 of the present disclosure is capable of generating laser-induced pressure waves that break up or disrupt the calcification deposit in the media 1030 of the arterial wall 1000", as illustrated in FIG. 10CAs shown, this increases the compliance of the arterial wall by 1000″ and the blood flow through it, while minimizing or preventing arterial wall dilation. In other words, one of the benefits of this disclosure is... FIG. 10C The sheath shown in the image may optionally include attenuation members, as described above. FIG. 5 The attenuation member 524″ is shown in the figure. Attenuation member 524″ or FIGS. 5A-5F The alternative examples shown can reduce or prevent the formation of bubbles on the exterior of the attenuating member and / or reinforce the sheath, thereby minimizing or preventing their expansion. The reinforced sheath and / or reduction or prevention of bubble formation on the exterior of the attenuating member reduce or prevent outward and inward fluid displacement to avoid arterial wall expansion and contraction, while allowing laser-induced pressure waves to penetrate the arterial wall and disrupt calcium deposits in the vascular tissue (e.g., the tunica media) and / or tissue layers (e.g., the tunica media layer).

[0197] FIGS. 10A-10D Similar numerical values ​​are used, but different figures include different notations, such as 'and' and their combinations, to indicate the values ​​resulting from changes occurring within the arterial wall during calcium formation and processing, which are progressively shown from one figure to the next. For the sake of brevity, some layers of the arterial wall 1000 are omitted in the discussion of certain figures, and numerical values ​​for some items of the arterial wall 1000 are omitted in certain figures. However, one should assume that the layers of the arterial wall 1000 and the formation therein have the same numerical values, even when derived from... FIGS. 10A-10D Omitted in .

[0198] refer to FIG. 11 The illustration depicts a method 1100 that uses a catheter to generate a laser-induced pressure wave to dispose of calcium deposits within the tissue (e.g., tunica media) and / or tissue layers (e.g., tunica media layer) of a blood vessel by disrupting the deposits, thereby increasing vascular compliance and thus increasing blood flow through it. This method 1100 can be used to treat calcium deposits in the tissue of coronary arteries and / or peripheral arteries. FIG. 11 Method 1100 includes, at step 1110, determining the location of calcifications in tissue (e.g., tunica media) and / or tissue layers (e.g., tunica media layer) within the subject's blood vessels. The next step 1120 is optional and includes positioning a guidewire within the subject's blood vessels.

[0199] After the location of the calcified portion of the tissue (e.g., the media) and / or tissue layer (e.g., the media layer) within the vessel is determined, step 1130 can then be performed. Step 1130 includes introducing the laser catheter of the present disclosure and the sheath of the present disclosure located on the laser catheter into the vessel. Step 1140 includes positioning the sheath and laser catheter (and optionally the guidewire) within the vessel such that the attenuating member within the sheath is adjacent to the portion of the vessel having the calcification and the distal end of the laser catheter is disposed within the attenuating member and adjacent to the vessel including the calcified portion. For example, if the clinician is using the laser catheter 170 described herein, which has a guidewire lumen, the laser catheter can be slid over the guidewire and into the vessel such that the emitter of the laser catheter is positioned adjacent to the vessel having the calcification. The sheath 250 of the present disclosure is then slid over the laser catheter 170 to a position within the vessel such that the attenuating member is adjacent to the vessel including the calcified portion. Thus, the emitter will be disposed within the portion of the sheath including the attenuating member.

[0200] The method 1100 also includes step 1150, which includes introducing a liquid medium (e.g., a contrast medium) having a light-absorbing material to the distal end of the laser catheter, where the laser catheter is disposed within the sheath and preferably within the portion of the sheath including the attenuating member. At step 1160, the emitter on the laser catheter is activated, thereby initiating the formation of a laser-induced pressure wave, a portion of which passes through at least the sheath including the attenuating member, thereby disrupting the calcification in the vessel. That is, the laser-induced pressure wave breaks and / or shatters the calcified portion of the tissue (e.g., the media) and / or tissue layer (e.g., the media layer) into smaller particles. Disrupting the calcified portion within the tissue of the vessel causes the calcified portion to crack apart as the laser-induced pressure wave is absorbed by the calcified portion, thereby increasing the compliance of the arterial wall, which in turn results in improved blood flow and positive effects on other health conditions.

[0201] Step 1170 of the method 1100 can include continuing to insert the liquid medium to the distal end of the laser catheter and axially translating the laser catheter and / or the sheath to disrupt a portion of the calcified tissue of the vessel within the same portion or other portions of the vessel. Also, any of the steps of the method 1100 can be repeated until a sufficient amount of the calcification is disrupted and the compliance of the arterial wall is satisfactorily increased, as described in step 1180.

[0202] Further, although in the above description the laser catheter is described as being inserted into the vessel prior to the sheath, the sheath can be inserted into the vessel prior to the laser catheter. In this case, the laser catheter can be slid over the sheath and into the vessel such that the emitter of the laser catheter is positioned adjacent to the vessel having the calcification. The laser catheter can then be slid over the sheath to a position within the vessel such that the attenuating member is adjacent to the vessel including the calcified portion. Thus, the emitter will be disposed within the portion of the sheath including the attenuating member. FIG. 11While not shown in FIG. 12A, in some cases, the method 1100 can include the step of activating at least one energy source coupled with at least one emitter encased within the sheath to emit and send pulses of laser light energy into and / or react with the liquid medium to generate a propagating laser-induced pressure wave to transport the therapeutic agent from outside of the sheath through the fissure in the calcified portion and / or potentially through (or to).

[0203] Referring to FIG. 12 , a kit 1200 is illustrated that includes a laser catheter assembly 1208 and a sheath assembly 1204. The sheath assembly 1204 can also be referred to as an outer sheath assembly 1204 due to its disposition relative to the laser catheter assembly 1208. FIG. 13 Illustrated in FIG. 12 is the sheath assembly 1204 shown in FIG. 12A, FIG. 14 Illustrated in FIG. 12 is the laser catheter assembly 1208 shown in FIG. 12A. The sheath assembly 1204 can include a proximal end portion, a distal end portion 1240, and a sheath 1212 having a working length of between about 50 cm and 200 cm (including 140 cm), and a lumen 1224 extending between these end portions. The sheath 1212 can also be referred to as an outer sheath 1212 due to its disposition relative to the laser catheter assembly 1208. The distal end portion 1240 is shown in further detail in FIG. 13A . The proximal end of the sheath assembly 1204 can include a bifurcator 1216 (or Y-connector) that is coupled to the sheath 1212 by a luer fitting 1220. The bifurcator 1216 can include a tube 1228 that extends in one direction (e.g., an axial direction) and another tube 1232 that extends in a direction that is offset from the tube 1228. The tube 1228 can have an opening 1224 through which a guidewire (not shown) can pass into the proximal end of the sheath assembly 1204. The tube 1228 can also include a hemostatic valve at or near the opening 1224. A lumen through which the guidewire can extend from the proximal end of the sheath assembly 1204 to the distal end of the sheath assembly 1204. The tube 1232 can include a tube stopcock 1236 through which a liquid medium can enter the sheath assembly 1204.

[0204] Referring to FIG. 13A , FIG. 13B , 13C , and 13C', an enlarged view of the distal end portion 1240 of the sheath assembly 1204 is illustrated having a lumen 1224 therethrough. The distal end portion 1240 of the sheath assembly 1204 can include a sheath 1212 (or outer cannula), an inner liner 1296 disposed radially or concentrically within the sheath 1212, an outer band 1272 FIG. 13C) and a tapered end 1276 disposed distal to the outer band 1272. The outer band 1272' may alternatively be integrally disposed within the distal end of the sheath 1212', such that the outer sheath (or sleeve) 1212' covers ( FIG. 13C ')Outer band 1272'. The distal portion 1240 of the sheath 1212 may also have an attenuation member formed therein. The attenuation member may be included throughout the entire length of the sheath 1212, or only at the distal portion 1240. Assuming the length of the sheath 1212 is 140 cm, the length of the distal portion 1240 including the attenuation member may be between 0.010 and 10.0 cm, which represents between 0.05% and 20.0% of the length of the sheath 1212.

[0205] The attenuation component may include one or more coils 1268 integrally formed of flat wire within the sheath 1212. Examples of flat wire include... FIG. 16 As shown, the cross-sectional width (X) of the flat wire is 0.005 inches, and the cross-sectional height (Y) is 0.001 inches. The flat wire can be made of stainless steel (such as 304 stainless steel) or other types of metals or metal alloys. Furthermore, the flat wire is preferably made in alternative dimensions, such as a cross-sectional width (X) between 0.001 and 0.010 inches, and a cross-sectional height (Y) between 0.0005 and 0.015 inches. Alternatively, round wire with a diameter between 0.0005 and 0.015 inches is preferred instead of flat wire.

[0206] As discussed herein, it may be desirable for the ratio of the open area of ​​the attenuation member to the total area of ​​the attenuation member to be within a certain range, for example, between 30% and 70%, and possibly between 40% and 60%, more likely between 45% and 55%, such as 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, or 55%. Although round wire can be used to form the coil 1268, using flat wire to form the coil 1268 allows the attenuation member to have a thinner overall longitudinal cross-sectional profile, while reducing the amount of open area per turn of wire, since the height of the flat wire can be less than the width of the flat wire. The width of the flat wire provides the desired ratio of the open area of ​​the attenuation member to the total area of ​​the attenuation member, while the height of the material increases the strength of the coil to withstand laser-induced pressure waves without breaking. In other words, the smaller longitudinal cross-sectional profile reduces the overall diameter of the sheath assembly, allowing the kit to fit into smaller-sized pulses while maintaining sufficient strength and stiffness to absorb and attenuate laser-induced pressure waves.

[0207] There are three factors in determining the percentage of open area in the attenuation member: (1) the width of the flat wire (or diameter of the round wire); (2) the number of windings of the flat wire; and (3) the gap between each turn of wire. Given the desired percentage of open area in the attenuation member, once two of these factors are determined, the third factor can be resolved. In order to maintain a certain percentage of open area in the attenuation member, there is an inverse relationship between the number of windings and the width of the flat wire (or diameter of the round wire). That is, for a certain percentage of open area in the attenuation member, the number of turns per inch decreases as the wire width increases, and the number of turns per inch increases as the wire width decreases. Further, there is an inverse relationship between the number of turns per inch and the gap between the wire turns. That is, for a certain percentage of open area in the attenuation member using a predetermined wire size, the number of turns per inch increases as the gap between the wire decreases. Further, there is a direct relationship between the size of the gap between the wire and the amount of open area in the attenuation member. That is, for a given wire width, the larger the gap between each turn, the larger the open area in the attenuation member, and the smaller the gap between each turn, the smaller the open area in the attenuation member.

[0208] For example, assume the attenuation member is comprised of flat wire that is 0.005 inches wide and 0.001 inches tall, and that an expected open area is between 30% and 70%, then the attenuation member can include between about 75 and 125 turns (or wraps) per inch. Specifically, the gap between each turn of 0.005 inches wide flat wire is about 0.008 inches, which results in an open area of about 61.5%, while the gap between each wrap of 0.005 inches wide flat wire is about 0.003 inches, which results in an open area of about 37.5%. Further, the gap between each turn of 0.005 inches wide flat wire is about 0.005 inches, which results in an open area of about 50%. Thus, the attenuation member can be comprised of flat wire such that the attenuation member includes between 75 and 125 turns (or wraps) per inch of flat wire, between 80 and 120 turns per inch of flat wire, between 85 and 115 turns per inch of flat wire, between 90 and 110 turns per inch of flat wire, depending on the amount of open area desired within the attenuation member, the size (i.e., width) of the flat wire, and the gap between each turn of flat wire. Thus, it can also be preferable for the attenuation member to include about 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, or 125 turns per inch of flat wire, where the flat wire is wrapped such that the width (X) of the flat wire is parallel to the longitudinal axis of the jacket 1212, and the height (Y) of the flat wire is perpendicular to the longitudinal axis of the jacket 1212. Further, if it is desired for the attenuation member to have an expected open area between 30% and 70% using 0.004 inches wide flat wire, then the gap between turns can be between 0.0017 and 0.0093 inches, respectively. These are examples and should not limit the scope of the present disclosure, as it can be desirable to have flat wire that is 0.0002 to 0.010 inches wide and 0.0005 to 0.002 inches tall, as well as round wire that is 0.0005 to 0.010 inches in diameter. For these ranges of wire sizes, the gap between turns of wire and the number of turns per length (inches) of wire can be adjusted accordingly in order to produce the expected open area in the attenuation member.

[0209] After forming the sheath 1212 with the internally disposed dampening member, the sheath 1212 can have an inner diameter between 0.010 and 0.200 inches and an outer diameter of about 0.014 inches, such that the wall thickness of the sheath 1212 is between 0.002 and 0.015 inches. The sheath 1212 can be composed of a polymeric material, such as nylon- 12. As described above, the distal portion 1240 can also include an inner liner 1296 disposed radially or concentrically within the sheath 1212. The inner liner 1296 can be composed of a polymer, such as polyimide, having a thickness between 0.0005 and 0.010 inches, such as 0.0005, 0.0006, 0.0007, 0.0008, 0.0009, 0.001, 0.0015, 0.002, 0.00025, 0.003, 0.0035, 0.004, 0.0045, 0.005, 0.0055, 0.006, 0.0065, 0.007, 0.0075, 0.008, 0.0085, 0.0090, 0.0095, and 0.010 inches.

[0210] Likewise, the distal portion 1240 of the sheath assembly 1204 can include an outer band 1272 disposed about the distal end of the sheath 1212, which can also be referred to as a marker band, and a tapered tip 1276 disposed distally of the outer band 1272. The outer band 1272 can be composed of a highly radiopaque material, such as platinum-iridium alloy or a polymer doped with a radiopaque material, such as barium sulfate, bismuth subcarbonate, bismuth oxychloride, or tungsten. The tapered tip 1276 can be composed of the same material as the sheath 1212 or an alternative material, such as nylon, pebax, polysulfone, HDPE, LDPE, UHMWPE, polypropylene, polyolefin, carbothane, polyurethane, Suralyn, an ionomer, Estane, EPTFE, PTFE, or FEP. Thus, the tapered tip 1276 can be integrally formed with the sheath 3012 or formed as a separate component. The perimeter of the tapered tip 1276 can taper radially inwardly from its proximal end to its distal end by between 1 and 10 degrees (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 degrees).

[0211] It can also be preferred that the inner diameter of the tapered tip 1276 is slightly smaller than the inner diameter of the inner liner 1296 of the sheath 1212, especially when the inner liner 1296 is omitted from the distal end 1240 of the sheath assembly 1204. For example, it can be preferred that the tapered tip 1276 seals the interface between the sheath assembly 1204 and the laser catheter assembly 1208 such that the escape of liquid media at the distal end of the kit 1200 is minimized or reduced. If the 5 French size laser catheter 1280 of the laser catheter assembly 1208 has an outer diameter of about 0.056 inches, it can be preferred that the inner diameter of the tapered tip 1276 is about 0.057 inches, leaving a radial distance or gap of about 0.0005 inches between the laser catheter 1280 and the tapered tip 1276. For purposes of this disclosure, about 0.0005 inches means 0.0001 to 0.001 inches. Further, if the 6 French size laser catheter 1280 of the laser catheter assembly 1208 has an outer diameter of about 0.069 inches, it can be preferred that the inner diameter of the tapered tip 1276 is about 0.070 inches, leaving a distance or gap of about 0.0005 inches between the laser catheter 1280 and the tapered tip 1276. Although the above examples include a gap of about 0.0005 inches between the laser catheter 1280 and the tapered tip 1276, such a gap can be between 0 and 0.002 inches and still perform adequate sealing.

[0212] The gap between the laser conduit 1280 and the liner 1296 (of the sheath 1212) is preferably larger than the gap between the laser conduit 1280 and the tapered end 1276, thereby allowing liquid media to enter the gap between the laser conduit 1280 and the liner 1296. For example, for a 5-French size laser conduit 1280 of laser conduit assembly 1208 with an outer diameter of approximately 0.056 inches, it is preferable that the inner diameter of the liner 1296 is approximately 0.0615 inches, thus leaving a radial distance or gap of approximately 0.00275 inches between the laser conduit 1280 and the liner 1296, which is approximately five times the gap between the laser conduit 1280 and the tapered end 1276. For the 6-French-sized laser conduit 1280 of the laser conduit assembly 1208, with an outer diameter of approximately 0.069 inches, it is preferable that the inner diameter of the liner 1296 is approximately 0.0745 inches, thereby leaving a distance or gap of approximately 0.00275 inches between the laser conduit 1280 and the liner 1296, which is approximately five times the gap between the laser conduit 1280 and the tapered end 1276. Accordingly, the lumen diameter in the liner 1296 is larger than the lumen diameter in the tapered end 1276. Although the above embodiment includes a radial gap of approximately 0.00275 inches between the laser conduit 1280 and the liner 1296, this radial gap can be between approximately 0.001 and 0.010 inches and still provide a sufficient amount of liquid medium to enter the radial gap and generate the desired pressure wave upon exposure to laser energy.

[0213] refer to FIG. 14 and FIG. 14A , plotted FIG. 12 The laser conduit assembly 1208 is shown. An example of the laser conduit assembly 1208 is the Turbo-Elite manufactured by The Spectranetics. TMLaser atherectomy catheter. Laser catheter assembly 1208 can include laser catheter 1280, a y-adapter 1244, a luer adapter 1248, another sheath 1252, and a coupler 1256. Coupler 1256 is coupled to a laser system, such as a CVX-300 excimer laser system, which is also produced by The Spectranetics Corporation. Sheath 1252 is coupled to coupler 1256, and sheath 1252 encloses a fiber bundle that passes through y-adapter 1244 and laser catheter 1280. Coupler 1256 is configured to enclose or include the fiber bundle. Y-adapter 1244 can be coupled to the proximal end of sheath 1280. In addition, luer adapter 1248 can also be coupled to the proximal end of y-adapter 1244, providing an entry point for a guidewire to enter and pass through laser catheter assembly 1208. Distal portion 1260 of laser catheter assembly 1208 can include a radiopaque outer band 1284 and an emitter 1288 disposed distal to radiopaque outer band 1284, where emitter 1288 is the distal end of a fiber or is coupled to a fiber.

[0214] Reference is made to FIG. 15 FIG. 15, which illustrates a flowchart that exemplifies steps of a method 1500 for removing a plaque buildup or occlusive disease by performing an atherectomy and treating a remaining portion of an endoluminal vessel occlusion using a kit 1200 (illustrated in FIG. 14 ) that includes a laser catheter assembly 1208 (illustrated in FIG. 13 ) and a sheath assembly 1204 (illustrated in FIG. 12 ), by generating a laser-induced pressure wave in the presence of a liquid medium and breaking apart a portion of the vessel occlusion using laser catheter assembly 1208 in combination with sheath assembly 1204. The method 1500 can be used to treat coronary and / or peripheral arteries, including but not limited to arteries of the leg vessels, renal arteries, subclavian arteries, and the like. FIG. 15The method 1500 in the's includes determining a location of a vessel occlusion in a vessel (or blood vessel) of a subject at step 1505. The next step 1510 is optional and includes positioning a guidewire 1292 at the vessel occlusion and / or inserting the guidewire 1292 through the vessel occlusion or through a passageway beyond the vessel occlusion. Step 1515 includes inserting a plaque removal device on the guidewire 1292 and into the vessel of the patient. One type of plaque removal device is an ablation catheter, such as the laser catheter assembly 1208 discussed herein, which is capable of ablating at least a portion of the vessel occlusion. Other types of ablation catheters include radiofrequency ablation catheters, microwave ablation catheters, and cryoablation catheters. Other plaque removal devices besides ablation catheters, such as mechanical plaque removal devices, can also be used to remove the vessel occlusion. Assuming the laser catheter assembly 1208 is used as the plaque removal device, the sheath assembly 1204 can also be introduced into the vessel of the patient simultaneously or sequentially with the laser catheter assembly 1208, e.g., before or after the laser catheter assembly 1208 is introduced into the vessel of the patient.

[0215] Once the laser catheter assembly 1208 and the sheath assembly 1204 (and particularly the laser catheter 1280 and the sheath 1212) are respectively positioned within the vessel of the patient, the laser catheter 1280 is positioned beyond the distal end of the sheath 1212 and adjacent to the vessel occlusion at step 1520. The clinician using the kit 1200 will be able to determine that the laser catheter assembly 1208 (and particularly the emitter 1288) is positioned beyond the distal end 1240 of the sheath assembly 1204 and adjacent to the vessel occlusion because the radiopaque outer band 1284 of the laser catheter 1280 will be shown to be distal to the outer band 1272 of the sheath assembly 1204 under fluoroscopy, as shown in FIG. 12A At this point, step 1525 can be initiated by activating the emitter 1288, e.g., by providing laser light energy thereto, and ablating the vessel occlusion (or a portion thereof), as shown in FIG. 8G 、 FIG. 8H and / or FIG. 8H 'where the laser catheter assembly 1208 and the sheath assembly 1204 respectively replace the sheath 250 and the catheter 170 in the '. FIG. 8G 、 FIG. 8H and / or FIG. 8H '.

[0216] After the vessel occlusion (or a portion thereof) is removed from the vessel, step 1530 can then be performed. Step 1530 includes positioning the sheath assembly 1204 over the laser catheter assembly 1208 (and particularly positioning the sheath 1212 over the laser catheter 1280) within the vessel of the subject and adjacent to the vessel occlusion, similar to the manner in which the sheath 250 and the catheter 170 are positioned in the '. FIG. 8H The axial positions of the laser catheter 1280 and the sheath 1212 can be confirmed by observing the radiopaque outer band 1284 of the laser catheter 1280 and the radiopaque outer band 1272 of the sheath 1212 under fluoroscopy.FIG. 8H and FIG. 8H one or both components relative to one another to adjust. For purposes of clarity, FIG. 12A and FIG. 12B corresponding to if FIG. 8H Catheter 170 and sheath 250 would be replaced with laser catheter 1280 and sheath 1212, how laser catheter assembly 1240 and sheath assembly 1204 (and in particular laser catheter 1280 and sheath 1212) would be oriented in the vessel, and FIG. 12B corresponding to if FIG. 8H Catheter 170 and sheath 250 would be replaced with laser catheter 1280 and sheath 1212, how laser catheter 1280 and sheath 1212 would be oriented in the vessel. In particular, the axial positions of laser catheter 1280 and outer sheath 1212 can be axially aligned such that emitter 1288 is located within attenuating member 1268 of sheath 1212, and sheath 1212 and the corresponding portion of attenuating member 1268 are adjacent to the vessel occlusion (or the remaining portion thereof). That is, step 1530 includes positioning sheath 1212 over laser catheter 1280 located within a vessel of a subject and adjacent to the vessel occlusion such that distal end 1260 of laser catheter assembly 1208 (including emitter 1288 thereof) is located within distal end 1240 of sheath assembly 1208, such that emitter 1288 is located within attenuating member 1268 of sheath assembly 1204, and outer band 1284 of laser catheter assembly 1208 is proximal of radiopaque outer band 1272 of sheath assembly 1204, as illustrated in FIG. 12B (and FIG. 8H ).

[0217] Once distal portions 1240, 1260 of sheath assembly 1204 and laser catheter assembly 1208 are disposed adjacent to the vessel occlusion such that emitter 1288 and attenuating member 1268 are axially aligned and adjacent to the vessel occlusion, a liquid medium can be introduced to distal end 1260 of laser catheter assembly 1208, as described in step 1535 of FIG. 15 Liquid medium can be introduced to kit 1500 through tube 1232 and / or tube stopper 1236 located at the proximal end of sheath assembly 1204. With continued reference to FIG. 15Step 1540 includes activating the energy source (e.g., laser) to generate laser-induced pressure waves in the presence of the liquid medium and to disrupt a portion of the vessel occlusion. The laser catheter assembly 1208 and the distal end 1240, 1260 of the sheath assembly 1204 can be used to traverse the entire vessel occlusion or to only disrupt a portion of the vessel occlusion. That is, the laser catheter assembly 1208 and the sheath assembly 1204 (and particularly their respective distal portions 1240, 1260) can be moved axially relative to one another and / or together while emitting laser-induced pressure waves to disrupt a portion of the vessel occlusion. While the emitter 1288 is activated, it can be desirable to translate the laser catheter assembly 1208 within the sheath assembly 1204 while the sheath assembly 1204 remains stationary as the liquid medium continues to be introduced to the distal end 1210 of the set 1200. For example, it can be desirable to axially move the laser catheter assembly 1208 within the sheath assembly 1204 in a proximal direction to retract the laser catheter assembly 1208 within the sheath assembly 1204 at a rate between 0.5 mm / sec and 5 mm / sec, and particularly at a rate less than or equal to 4.5, 4.0, 3.5, 3.0, 2.5, 2.0, 1.5, or 1 mm / sec. In addition to moving the laser catheter assembly 1208 within the sheath assembly 1204 in a proximal direction, the laser catheter assembly 1208 can be moved within the sheath assembly 1204 in a distal direction while keeping the emitter 1288 proximal of the distal end 1240 of the sheath assembly 1208. For purposes of clarity, the emitter 1288 is within the distal end 1240 of the sheath assembly 1208 during emitter activation and proximal and distal movement of the sheath assembly 1208 to disrupt the calcification such that the emitter 1288 is within the attenuating member 1268 of the sheath assembly 1204 and the outer band 1284 of the laser catheter assembly 1208 is proximal of the radiopaque outer band 1272 of the sheath assembly 1204.

[0218] During the disruption of the calcification, it can be desirable to adjust the settings of the laser system coupled to the laser catheter assembly 1208 such that the fluence produced by the emitter 1288 is between 30 and 80 mJ / mm 2 , more preferably between 40 and 70 mJ / mm 2 , and even more preferably 45, 50, 55, 60 mJ / mm 2a repetition rate of between 25 and 80 hertz, including 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, and 80 hertz. It can also be desirable for the laser to have a pulse width of between 125 and 200 nanoseconds, including 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195, and 200 nanoseconds. As also discussed herein, the wavelength of the laser light energy and the wavelength emitted by the emitter can include various wavelengths, including wavelengths between about 150 nanometers and about 400 nanometers, such as 308 nanometers.

[0219] If the use of the laser catheter assembly 1208 and the sheath assembly 1204 to disrupt a portion of the vascular occlusion is continued, the laser catheter assembly 1208 and the sheath assembly 1204 are used as described in step 1540. However, if the clinician wishes to stop using the laser catheter assembly 1208 and the sheath assembly 1204 to disrupt a portion of the vascular occlusion and use the laser catheter assembly 1208 to perform additional ablation, the clinician repeats step 1520 (and additional subsequent steps) as illustrated in FIG. 12B (and FIG. 15 and the distal portion 1260 of the laser catheter assembly 1208 is again extended beyond the distal portion 1240 of the sheath assembly 12 as illustrated in FIG. 12B (and FIG. 12A and as illustrated in FIG. 12B (and FIG. 8G , FIG. 8H and / or FIG. 8H ). After the vascular occlusion has been satisfactorily ablated and disrupted by repeating steps 1520 through 1540 or 1545, the activation of the emitter and the introduction of the liquid medium into the kit 1200 are stopped and the kit is removed from the patient’s vasculature.

[0220] As described above, the transmission of the pulses of light energy from the emitter into the liquid medium creates laser-induced pressure waves and / or bubbles and additional resultant pressure waves that disrupt at least a portion of the vascular occlusion. The catheter can include a guidewire lumen through which a guidewire can be passed and through the vascular occlusion. It can also be desirable to excite and vibrate the guidewire to increase the ability of the guidewire to pierce and pass through the vascular occlusion. Accordingly, the present disclosure also contemplates directing the laser light energy emitted by the emitter into the liquid medium in a direction that causes the laser-induced pressure waves to propagate toward the guidewire lumen and / or the guidewire such that the laser-induced pressure waves excite and vibrate the guidewire.

[0221] Although FIG. 15The method shown in FIG. 15 illustrates that steps 1505-1550 of method 1500 are performed consecutively, but any or all of the steps within method 1500 can be performed in any order and / or in parallel with any other steps. For example, some steps can be performed without performing other steps. After completing step 1535 and / or step 1540, the combined laser catheter and sheath can optionally be repositioned within the vessel and adjacent to another portion thereof. Similarly, after completing step 1535 and / or step 1540, the emitter can optionally be repositioned within the sheath. The sheath can be repositioned within the vessel and / or the emitter can be repositioned within the sheath.

[0222] Similar to FIGS. 12-14 the laser catheter assembly 1208 and sheath assembly 1204 can be substituted for the catheter 170 and sheath 250 shown in FIG. 8G , FIG. 8H and FIG. 8H to perform the method of FIG. 15 which is similar to the methods of FIG. 9A and FIG. 9B to perform an atherectomy and then to destroy the remaining portion of the vessel occlusion, FIGS. 12-14 the laser catheter assembly 1208 and sheath assembly 1204 (and in particular the laser catheter 1280 and sheath 1212) can be substituted for the catheter 170 and sheath 250 shown in FIG. 10C to perform the method of FIG. 15 which is similar to the methods of FIG. 9A and FIG. 9B to perform the method illustrated in FIG. 11 As described above, FIG. 11 illustrates a method of using the kit 1200 to generate a laser-induced pressure wave to treat a calcific deposit in a tissue (such as a media) and / or a tissue layer (such as a media layer) of a blood vessel by destroying the calcific deposit to increase the compliance of the vessel to increase blood flow therethrough.

[0223] With reference to FIG. 17 and FIG. 17A , an outer sheath assembly 1704 for a kit (not shown) is illustrated that can also include a bifurcator (such as a bifurcator or Y-connector) and a laser catheter assembly (such as laser catheter assembly 1208). The sheath assembly 1704 can include a luer fitting 1720 at a proximal end portion for detachably coupling to the bifurcator. The sheath assembly 1704 can also include a distal end portion 1740 and an outer sheath 1712 having a working length of between about 50 cm and 200 cm (including 140 cm) and a lumen 1724 extending between these end portions. FIG. 17 , FIG. 17A and FIG. 18The outer sheath 1712 of the sheath assembly 1704 can be used in place of the outer sheath 1212 discussed above in FIG. 12 and FIG. 13 .

[0224] Reference is now made to FIG. 17A and FIG. 18 , which depict enlarged views of a distal end portion 1740 of the sheath assembly 1704 and a partial exploded view showing the layers of the sheath 1712, respectively. The distal end portion 1740 of the sheath assembly 1704 can include a tapered tip 1776, an outer band 1772 disposed proximal to the tapered tip 1776 and around the distal end of the sheath 1712, and the distal end of the sheath 1712.

[0225] The tapered tip 1776 can be composed of various materials, such as nylon, pebax, polysulfone, high density polyethylene (HDPE), low density polyethylene (LDPE), ultra-high molecular weight polyethylene (UHMWPE), polypropylene, polyolefin, carbothane, polyurethane, Suralyn, ionomer, Estane, expanded polytetrafluoroethylene (EPTFE), polytetrafluoroethylene (PTFE), or fluorinated ethylene propylene (FEP). The tapered tip 1776 can be formed integrally with the sheath 1712 or as a separate component. The tapered tip 1776 can taper radially inwardly between 1 and 10 degrees (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 degrees) from its proximal end to its distal end. It can be preferable for the tapered tip 1776 to have an inner diameter that facilitates sealing the interface between the sheath assembly 1704 and the laser catheter assembly such that the escape of liquid media at the distal end of the set is minimized or reduced. If the outer diameter of a 6 French size laser catheter of the laser catheter assembly is about 0.069 inches, it can be preferable for the inner diameter of the tapered tip 1776 to be about 0.058 inches. If a 7 French size laser catheter of the laser catheter assembly is to be used, it can be preferable for the inner diameter of the tapered tip 1776 to be about 0.071 inches. If an 8 French size laser catheter of the laser catheter assembly is to be used, it can be preferable for the inner diameter of the tapered tip 1776 to be about 0.082 inches.

[0226] The outer band 1772, which can also be referred to as a marker band, can be composed of a highly radiopaque material, such as platinum-iridium alloy or a polymer doped with a radiopaque material, such as barium sulfate, bismuth subcarbonate, bismuth oxychloride, or tungsten.

[0227] Reference is now made to FIG. 18The sheath 1712 includes an outer sleeve 1778 that covers an outer band 1772 (not shown). The sheath 1712 also includes an attenuation member 1768 disposed radially or concentrically within the outer band 1772, an intermediate layer 1770 disposed radially or concentrically within the attenuation member 1768, and an inner liner 1775 disposed radially or concentrically within the intermediate layer 1770. Proximal to the outer band 1772, the sheath 1712 includes similar structure. Specifically, the attenuation member 1768 is disposed radially or concentrically within the outer sleeve 1778, the intermediate layer 1770 is disposed radially or concentrically within the attenuation member 1768, and the inner liner 1775 is disposed radially or concentrically within the intermediate layer 1770. In some embodiments, the attenuation member 1768 is only present at the distal end portion 1740. Assuming the length of the sheath 1712 is 140 centimeters, the length of the distal end portion 1740 that includes the attenuation member 1768 can be between 0.010 and 10.0 centimeters, which represents between 0.05% and 20.0% of the length of the sheath 1712.

[0228] The outer sleeve 1778 can be constructed of various materials, such as nylon, pebax, polysulfone, HDPE, LDPE, UHMWPE, polypropylene, polyolefins, carbothane, polyurethane, Suralyn, ionomers, Estane, EPTFE, PTFE, or FEP. If a 6 French size laser catheter is to be used with the laser catheter assembly, the outer sleeve 1778 can provide an outer diameter for the sheath 1712 of between 0.058 and 0.098 inches, such as 0.058, 0.062, 0.066, 0.070, 0.074, 0.078, 0.082, 0.086, 0.090, 0.094, and 0.098 inches. If a 7 French size laser catheter is to be used with the laser catheter assembly, the outer sleeve 1778 can provide an outer diameter for the sheath 1712 of between 0.071 and 0.111 inches, such as 0.071, 0.075, 0.079, 0.083, 0.087, 0.091, 0.095, 0.099, 0.103, 0.107, and 0.111 inches. If an 8 French size laser catheter is to be used with the laser catheter assembly, the outer sleeve 1778 can provide an outer diameter for the sheath 1712 of between 0.082 and 0.122 inches, such as 0.082, 0.086, 0.090, 0.094, 0.098, 0.102, 0.106, 0.110, 0.114, 0.118, and 0.122 inches. The outer sleeve 1778 can have a wall thickness of between 0.0015 and 0.0035 inches, such as 0.0015, 0.0017, 0.0019, 0.0021, 0.0023, 0.0025, 0.0027, 0.0029, 0.0031, 0.0033, and 0.0035.

[0229] The attenuating member 1768 is a braided structure 1768. The braided structure 1768 can include between 4 and 28 carriers, more particularly between 12 and 20 carriers, such as 12, 13, 14, 15, 16, 17, 18, 19, or 20 carriers. Each carrier can include between 1 and 10 filaments, such as 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 filaments. Each filament can have a cross-sectional height between 0.0005 and 0.005, such as 0.0005, 0.0007, 0.0009, 0.001, 0.002, 0.003, 0.004, and 0.005. Each filament can be a flat wire having a cross-sectional width between 0.0005 and 0.003, such as 0.0005, 0.0007, 0.0009, 0.001, 0.002, and 0.003. Each filament can be composed of stainless steel, such as 304 stainless steel, or other types of metals or metal alloys. The braided structure 1768 can have a braiding density with a pick per inch (PPI) between 20 and 100, particularly between 40 and 80 PPI, such as 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, and 80 PPI. The relationship between the open area and the closed area (or the ratio of the open area to the total area) within the braided structure 1768 should be such that a sufficient number of laser-induced pressure waves pass through the braided structure 1768, and the open area should allow the laser-induced pressure waves to pass therethrough while also limiting the size of the bubbles that can form outside of the sheath 1712. The open area of the braided structure 1768 can be between 45% and 85%, and possibly between 55% and 75%, such as 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, or 75%. The open area of the braided structure depends on the braiding density, the number of carriers in the braided structure 1768, the number of filaments in each carrier, and the size of the filaments.

[0230] The intermediate layer 1770 can be composed of various materials, such as nylon, pebax, polysulfone, HDPE, LDPE, UHMWPE, polypropylene, polyolefin, carbothane, polyurethane, Suralyn, ionomer, Estane, EPTFE, PTFE, or FEP. The intermediate layer 1770 can have a wall thickness between 0.0005 and 0.0025 inches, such as 0.0005, 0.0007, 0.0009, 0.0011, 0.0013, 0.0015, 0.0017, 0.0019, 0.0021, 0.0023, and 0.0025.

[0231] The inner liner 1775 can be constructed of various materials, such as polyamide or fluoropolymers, particularly Neoflon FEP NP-101 available from Daikin America. If a 6 French size laser catheter is to be used with the laser catheter assembly, the inner liner 1775 can provide an inner diameter for the sheath 1712 of between 0.040 and 0.080 inches, such as 0.044, 0.048, 0.052, 0.056, 0.060, 0.064, 0.068, 0.072, 0.076, and 0.080 inches. If a 7 French size laser catheter is to be used with the laser catheter assembly, the inner liner 1775 can provide an inner diameter for the sheath 1712 of between 0.053 and 0.093 inches, such as 0.053, 0.057, 0.061, 0.065, 0.069, 0.073, 0.077, 0.081, 0.085, 0.089, and 0.093 inches. If an 8 French size laser catheter is to be used with the laser catheter assembly, the inner liner 1775 can provide an inner diameter for the sheath 1712 of between 0.064 and 0.104 inches, such as 0.064, 0.068, 0.072, 0.076, 0.080, 0.084, 0.088, 0.092, 0.096, 0.100, and 0.104 inches. The inner liner 1796 can have a wall thickness of between 0.0005 and 0.0025 inches, such as 0.0005, 0.0007, 0.0009, 0.0011, 0.0013, 0.0015, 0.0017, 0.0019, 0.0021, 0.0023, and 0.0025.

[0232] The kit including the sheath assembly 1704 can be used to perform any of the methods described herein. In some embodiments, the sheath assembly 1704 is capable of resisting damage for a duration of at least 1, 2, 3, 4, or 5 minutes (or any duration therebetween) when laser pulses are emitted out of the laser catheter during performance of such methods. More particularly, the sheath assembly 1704 is capable of resisting damage when used with the Spectranetics 1.4, 1.7, and 2.0 Turbo-Elite TM and 2.0 Turbo-Power TMWhen the laser catheter emits laser pulses at a flux of 60 and a frequency of 25 Hz into a contrast medium consisting of 50% Optiray 320 contrast agent and saline solution injected at a rate of 5 mL / min into the sheath 1704, the sheath 1704 is resistant to damage. To facilitate this capability, one or both of the outer sheath 1778 and the intermediate layer 1770 may be integrally formed with the braided structure 1768 (i.e., formed such that one or both of the outer sheath 1778 and the intermediate layer 1770 occupy at least some of the open area of ​​the braided structure). For example, the liner 1775 may be extruded, the intermediate layer 1770 may be over-extruded on the liner 1775, the braided structure 1768 may be positioned on the intermediate layer 1770, and the outer sheath 1778 may be over-extruded on the braided structure 1768. The sheath 1712 is laminated and coupled to the Luer connector 1720, and the outer sheath 1778 may be peeled off at the distal end of the sheath 1712.

[0233] Compared to conventional unreinforced and / or reinforced sheaths, such as sheath assemblies comprising various or multiple layers or using other manufacturing processes, this article is relative to FIGS. 17-18 The disclosed and discussed sheath assembly 1704 is less susceptible to damage when used with a laser catheter, and laser pulses are emitted into the contrast agent within this sheath assembly for a shorter or longer duration, specifically, the duration of continuous laser pulse emission is greater than 20 seconds, 40 seconds, 1 minute, and / or 2 minutes. Minimizing and / or preventing such potential damage to the sheath, such as bulging, splitting, or delamination (in the case of a multi-layered sheath), forms a single unit within the sheath, thereby reducing the likelihood of increased difficulty experienced by the surgeon when translating the sheath across the patient's blood vessels and / or relative to the laser catheter.

[0234] refer to FIG. 19 An enlarged sectional view of another configuration of the outer sheath 1912 is shown. FIG. 19 The outer sheath 1912 shown is FIG. 18 The sheath 1712 shown is different because FIG. 18 The sheath 1712 shown includes an attenuation member 1768 and an intermediate layer 1770 disposed between the outer tube 1778 and the inner liner 1775, but FIG. 19 The outer sheath 1912 shown includes multiple pairs of attenuating members 1968 and an intermediate layer 1970 located between the outer tube 1978 and the inner liner 1996. That is, FIG. 19 The outer sheath 1912 shown includes multiple pairs of alternating attenuation members 1968 and intermediate layer 1970 located between the outer sheath 1978 and the inner liner 1996, wherein the attenuation members 1968 have a higher density than the intermediate layer 1970.

[0235] As described above, smaller sized blood vessels require laser catheters with reduced diameters to access the blood vessels, and smaller sized laser catheters can have limitations on the amount of energy that can be transmitted. That is, a reduced sized laser catheter can have fewer optical fibers or smaller diameter optical fibers than a larger sized laser catheter, thereby limiting the amount of energy that the reduced sized laser catheter can transmit before damage to the optical fibers. Moreover, if the optical fibers attempt to transmit too much energy, they will be damaged.

[0236] The amount of energy transmitted by the laser-induced pressure wave to the blood vessel (and the calcification included therein) is proportional to the amount of energy transmitted by the optical fibers to the liquid medium within the outer sheath. That is, the more energy that the optical fibers transmit to the liquid medium, the more energy that is transmitted by the laser-induced pressure wave to the blood vessel. Moreover, the less energy that is transmitted by the optical fibers to the liquid medium, the less energy that is transmitted by the laser-induced pressure wave to the blood vessel. Since a smaller sized laser catheter can have fewer optical fibers or smaller diameter optical fibers, the amount of energy transmitted by the optical fibers to the liquid medium, and the energy transmitted by the laser-induced pressure wave to the blood vessel, is limited, thereby potentially limiting the ability to disrupt the calcification in the blood vessel.

[0237] One way to compensate for the reduction in energy transmitted and emitted by the laser catheter includes increasing the amount of contrast agent of the liquid medium within the outer sheath. Transmitting pulses of light energy into the liquid medium creates bubbles. Bubbles can be created inside the sheath and / or outside the sheath when light is emitted from an emitter, such as a laser catheter, within a sheath containing an absorptive liquid medium. However, increasing the amount of contrast agent can create bubbles of an undesirable size within or outside the sheath, thereby potentially damaging the blood vessel.

[0238] Also, FIG. 19 The outer sheath 1912 illustrated in FIG. 19 includes pairs of attenuating members 1968 and intermediate layers 1970 between the outer sleeve 1978 and the inner liner 1996. That is, FIG. 19 The outer sheath 1912 illustrated in FIG. 19 includes pairs of alternating attenuating members 1968 and intermediate layers 1970 between the outer sleeve 1978 and the inner liner 1996, where the attenuating members 1968 have a higher density relative to the intermediate layers 1970. The plurality of alternating attenuating members 1968 and intermediate layers 1970 increase the index of refraction of the pressure wave transmitted to the blood vessel and do not increase the size of undesirable bubbles. The plurality of alternating attenuating members 1968 and intermediate layers 1970 form a composite structure that mimics an anisotropic metamaterial to increase the amplitude of the pressure wave transmitted through the sheath because the attenuating members 1968 are stiffer than the intermediate layers 1970, and alternating stiff and soft layers increase the amplitude of the pressure wave as it is transmitted through the alternating stiff and soft layers.

[0239] With continued referenceFIG. 19 The outer sheath 1912 includes an outer tube 1978, an inner liner 1996, and a plurality of alternating intermediate layers 1970 and attenuation members 1968 disposed radially or concentrically between the outer tube 1978 and the inner liner 1996. FIG. 19 The outer tube (1978) and inner lining (1996) can be made of respectively and FIG. 18 The outer tube 1778 and the inner lining 1796 are made of the same material. FIG. 19 The outer tube in 1978 and the inner lining in 1996 are related to FIG. 18 Compared to the inner liner 1776, the outer tube 1778 can be the same, similar, or smaller in size (e.g., smaller or reduced in thickness). FIG. 19 The intermediate layer 1970 and the attenuation component 1968 can be respectively composed of and FIG. 18 The intermediate layer 1770 and the attenuation member 1768 are made of the same material. FIG. 19 The intermediate layer in 1970 and the attenuation element in 1968 are... FIG. 18 The intermediate layer 1770 and the attenuation member 1768 can be of the same, similar or smaller size or thickness, respectively.

[0240] although FIG. 19 The intermediate layer in 1970 and the attenuation element in 1968 are... FIG. 18 The intermediate layer 1770 and the attenuation member 1768 can each have the same or similar thickness, but preferably, FIG. 19 The intermediate layer 1970 and attenuation member 1968 have smaller dimensions (e.g., smaller or reduced thickness) because it is preferable to increase the number of intermediate layers 1970 and attenuation members 1968 while maintaining... FIG. 19 The total diameter of the outer sheath in 1912 and FIG. 19 The overall dimensions (e.g., diameter) of the outer sheath are the same. One of the keys to increasing the amplitude of the pressure waves transmitted through the sheath and minimizing the size of unwanted bubbles is to increase the number of paired, alternating attenuation members 1968 and intermediate layers 1970 to form a composite structure that mimics anisotropic metamaterials.

[0241] With respect to the overall size of the outer jacket 1912, it can be desirable to use a 4 French, 5 French, 6 French, 7 French, or 8 French sized catheter in the vasculature below the patient’s knee. Generally, it can be desirable for the alternating attenuating members 1968 to have a relatively higher density compared to the intermediate layer 1970, while the intermediate layer 1970 will have a lower density compared to the attenuating members 1968. With respect to the materials of the catheter, such as polymers, elastomers, rubbers, and plastics, the density can be related to the hardness. For the purposes of this disclosure, it is assumed that the intermediate layer and the attenuating members are made of different types of these materials, and that the intermediate layer and the attenuating members are solid, the higher the density of the material, the more likely the higher the hardness, and the lower the density of the material, the more likely the lower the hardness. In other words, the density and hardness of the catheter material are directly related, one increases, the other also increases, one decreases, the other also decreases. Thus, it can be desirable to alternate the harder layers (e.g., the attenuating members 1968) with the relatively softer layers (e.g., the intermediate layer 1970). Notwithstanding the above, for the purposes of this disclosure, it is understood that if the attenuating members 1968 are composed of a metal, while the intermediate layer 1970 is composed of a polymer, elastomer, rubber, or plastic, the attenuating members 1968 are to be considered to have a greater density than the intermediate layer 1970, even if the attenuating members 1968 have openings, are porous, or are coiled, as shown in the configurations of FIG. 19 and FIG. 19

[0242] Hardness can be tested using a durometer, which is a gauge that measures the resistance to surface penetration. There are several scales of durometers, used for materials with different properties. Two common scales, using slightly different measurement systems, are the ASTM D2240 A scale and the D scale. The A scale is used for softer materials, while the D scale is used for harder materials. Higher numbers on the scale indicate materials that resist indentation more and are therefore harder. Lower numbers indicate softer, more flexible materials, while higher numbers indicate materials that are harder and generally more durable.

[0243] Along with the numbers, there is also an alpha scale that is graded with “A” and “D”, with “A” indicating softer materials and “D” indicating harder materials. This scale is commonly used for rubbers / elastomers and softer plastics, such as polyolefins, fluoropolymers, and vinyls. The hardness value is determined by the depth of the indenter foot of the durometer into the sample. Shore A is commonly used for flexible materials, while Shore D is used for semi-flexible materials.

[0244] ​While Shore hardness A is one scale and Shore hardness D is another scale, there can be an overlap between the two scales. For example, the Shore hardness A scale has a hardness of 0 to 100, while the Shore hardness D scale has a hardness of 0 to 100, but the range of Shore hardness 60A to Shore hardness 100A can overlap with the range of Shore hardness 0D to Shore hardness 60D. That is, the hardness range of Shore hardness 40A overlaps with the hardness range of Shore hardness 60D.

[0245] Another scale of hardness is the Rockwell scale. Rockwell hardness is often chosen for "harder" plastics, such as nylon, polycarbonate, polystyrene, and acetals. Three common Rockwell hardness scales are Rockwell A, Rockwell B, and Rockwell C. As with the scales for Shore hardness, a higher number indicates a harder material.

[0246] While the Shore hardness scale is one scale and the Rockwell hardness scale is another scale, there can be an overlap between the two scales. For example, the Shore hardness D scale has a hardness of 0 to 100, while the Rockwell hardness B scale has a hardness of 0 to 110, but the range of Shore hardness 75D to Shore hardness 100D can overlap with the range of Rockwell hardness 0B to Rockwell hardness 40B. That is, the hardness range of Shore hardness 25D overlaps with the hardness range of Rockwell hardness 40B. However, due to the different methods of measurement, a direct conversion between the scales can not be possible.

[0247] If an outer sleeve 1978 is included in the construction of the outer jacket 1912, it can be desirable for the hardness and / or density of the outer sleeve 1978 to be the same or relatively similar to the hardness and / or density of the intermediate layer 1970, or it can be desirable for the hardness and / or density of the outer sleeve 1978 to be between the hardness and / or density of the attenuating member 1968 and the intermediate layer 1970. That is, it can be desirable for the hardness and / or density of the outer sleeve 1978 to be less than the hardness and / or density of the attenuating member 1968, and the hardness and / or density of the outer sleeve 1978 can be the same or greater than the hardness and / or density of the intermediate layer 1970.

[0248] As described above, one of the keys to increasing the amplitude of the pressure wave transmitted through the jacket and minimizing the size of the undesirable bubbles is to increase the number of layers of the pair of alternating attenuating members 1968 and intermediate layers 1970, forming a composite structure that mimics an anisotropic metamaterial. Also, the alternating hardness of the plurality of attenuating members 1968 and intermediate layers 1970 forms such a composite structure that amplifies the pressure wave.

[0249] For example, it can be desirable for the difference in hardness (or stiffness) between the attenuating member 1968 and the intermediate layer 1970 to be about a difference of about Shore 5A, Shore 10A, Shore 15A, Shore 20A, Shore 25A, Shore 30A, Shore 35A, Shore 40A, Shore 45A, Shore 50A, Shore 55A, Shore 60A, Shore 65A, or Shore 70A. It can also be desirable for the difference in hardness (or stiffness) between the attenuating member 1968 and the intermediate layer 1970 to be about a difference of about Shore 5D, Shore 10D, Shore 15D, Shore 20D, Shore 25D, Shore 30D, Shore 35D, Shore 40D, Shore 45D, Shore 50D, Shore 55D, Shore 60D, Shore 65D, or Shore 70D. It can also be desirable for the difference in hardness (or stiffness) between the attenuating member 1968 and the intermediate layer 1970 to be about a difference of about Rockwell 5B, Rockwell 10B, Rockwell 15B, Rockwell 20B, Rockwell 25B, Rockwell 30B, Rockwell 35B, or Rockwell 40B.

[0250] Because the attenuating member 1968 can be comprised of a material whose hardness can be more appropriately determined using one scale, while the intermediate layer 1970 can be comprised of a different material whose hardness can be more appropriately determined using a different scale, the difference in hardness between the materials can be determined using two or more scales. For example, if the hardness of the attenuating member 1968 is Shore 80D, while the hardness of the intermediate layer is Shore 85A (which is similar to Shore 35D), then the difference in hardness is about Shore 45D. Further, if the hardness of the attenuating member 1968 is Shore 90D, while the hardness of the intermediate layer is Shore 40A, and there is no overlap between the relevant hardnesses on the Shore A scale (which ranges from 0-100) and the Shore D scale, then the difference in hardness is Shore 60A plus Shore 30D (which ranges from 0-100, and Shore 100A overlaps at Shore 60D).

[0251] The attenuating member 1968 can be between Shore 80D and Rockwell 80B, and potentially more desirably between Rockwell 20B and Rockwell 70B. It can be desirable for the hardness of the intermediate layer 1970 to be between Shore 20D and Shore 80D, and potentially more desirably between Shore 35D and Shore 75D. It can be desirable for the hardness of the outer sleeve 1978 to be similar to the intermediate layer 1970.

[0252] The density of the attenuating member 1968 and the intermediate layer 1970 can differ simply due to the difference in materials, while the thickness of the attenuating member 1968 and the intermediate layer 1970 are substantially the same. Additionally or alternatively, the density of the attenuating member 1968 and the intermediate layer 1970 can also differ due to both the difference in materials and thickness of the attenuating member 1968 and the intermediate layer 1970.

[0253] Referring again to FIG. 3A-3C The outer sleeve 1978 can be constructed of various materials, such as nylon, pebax, polysulfone, HDPE, LDPE, UHMWPE, polypropylene, polyolefin, carbothane, polyurethane, Suralyn, ionomer, Estane, EPTFE, PTFE, or FEP. If a 6 French size laser catheter is to be used with the laser catheter assembly, the outer sleeve 1978 can provide an outer diameter for the sheath 1912 of between 0.058 and 0.098 inches, such as 0.058, 0.062, 0.066, 0.070, 0.074, 0.078, 0.082, 0.086, 0.090, 0.094, and 0.098 inches. If a 7 French size laser catheter is to be used with the laser catheter assembly, the outer sleeve 1978 can provide an outer diameter for the sheath 1912 of between 0.071 and 0.111 inches, such as 0.071, 0.075, 0.079, 0.083, 0.087, 0.091, 0.095, 0.099, 0.103, 0.107, and 0.111 inches. If an 8 French size laser catheter is to be used with the laser catheter assembly, the outer sleeve 1978 can provide an outer diameter for the sheath 1912 of between 0.082 and 0.122 inches, such as 0.082, 0.086, 0.090, 0.094, 0.098, 0.102, 0.106, 0.110, 0.114, 0.118, and 0.122 inches. The outer sleeve 1978 can have a wall thickness of between 0.0002 and 0.0035 inches, such as 0.0002, 0.0004, 0.0006, 0.0008, 0.001, 0.0012, 0.0015, 0.0017, 0.0019, 0.0021, 0.0023, 0.0025, 0.0027, 0.0029, 0.0031, 0.0033, and 0.0035.

[0254] Attenuation members 1968 can be solid structures or porous structures, such as those described in the present disclosure, including those composed of various metals and polymeric materials. If attenuation members 1968 are porous, they can be woven structures or coiled structures. If attenuation members 1968 are woven, the woven structure can include between 4 and 28 carriers, more specifically between 12 and 20 carriers, such as 12, 13, 14, 15, 16, 17, 18, 19, or 20 carriers. Each carrier can include between 1 and 10 filaments, such as 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 filaments. Each filament can have a cross-sectional height of between 0.0002 and 0.005 inches, such as 0.0002, 0.0003, 0.0005, 0.0007, 0.0009, 0.001, 0.002, 0.003, 0.004, and 0.005 inches. Each filament can be a flat wire having a cross-sectional width of between 0.0002 and 0.003 inches, such as 0.0002, 0.0003, 0.0005, 0.0007, 0.0009, 0.001, 0.002, and 0.003 inches. Each filament can be composed of stainless steel, such as 304 stainless steel, or other types of metals or metal alloys. The woven density of the woven structure can be between 20 and 200 wefts per inch (PPI), specifically between 40 and 80 PPI, such as 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, and 80 PPI. The relationship between the open area and the closed area (or the ratio of the open area to the total area) within woven structure 1968 should be such that a sufficient number of laser-induced pressure waves pass through woven structure 1968, and the open area should allow the laser-induced pressure waves to pass therethrough while also limiting the size of the bubbles that can form outside of sheath 1912. The open area of woven structure 1968 can be between 45% and 85%, possibly between 55% and 75%, such as 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, or 75%. The open area of the woven structure depends on the woven density, the number of carriers in the woven structure, the number of filaments in each carrier, and the size of the filaments.

[0255] The thickness of the attenuation member 1968 can be between 0.0002 and 0.0030 inches, such as 0.0002, 0.0005, 0.00075, 0.0010, 0.0015, 0.0020, 0.0025, and 0.0030 inches. Each attenuation member 1968 in the outer sheath 1912 can have the same (or similar) or different thicknesses and porosities. For example, each attenuation member 1968 in the outer sheath 1912 can increase in size or decrease in size as the attenuation member progresses from the inner liner 1996 to the outer sleeve 1978.

[0256] Similar to the attenuation member 1968, the intermediate layer 1970 can have the same (or similar) or different thicknesses. For example, each intermediate layer 1970 can increase or decrease in thickness in proportion to the adjustment in thickness of the attenuation member 1968 in the outer sheath 1912 as the attenuation member progresses from the inner liner 1996 to the outer sleeve 1978. Alternatively, the thickness of each intermediate layer 1970 can increase or decrease inversely to the adjustment in thickness of the attenuation member 1968 in the outer sheath 1912 as the attenuation member progresses from the inner liner 1996 to the outer sleeve 1978.

[0257] The intermediate layer 1970 can be constructed of various materials, such as nylon, pebax, polysulfone, HDPE, LDPE, UHMWPE, polypropylene, polyolefin, carbothane, polyurethane, Suralyn, ionomer, Estane, EPTFE, PTFE, or FEP. The intermediate layer 1970 can have a wall thickness between 0.0002 and 0.0030 inches, such as 0.0002, 0.0005, 0.00075, 0.0010, 0.0015, 0.0020, 0.0025, and 0.0030 inches.

[0258] The inner liner 1996 can be constructed of various materials, such as polyamide or fluoropolymers, particularly Neoflon FEP NP-101 available from Daikin America, PTFE, FEP, PFA, ETFE, EFEP. If a 6 French size laser catheter is to be used with the laser catheter assembly, the inner liner 1996 can provide an inner diameter for the outer sheath 1912 of between 0.040 and 0.080 inches, such as 0.044, 0.048, 0.052, 0.056, 0.060, 0.064, 0.068, 0.072, 0.076, and 0.080 inches. If a 7 French size laser catheter is to be used with the laser catheter assembly, the inner liner 1996 can provide an inner diameter for the outer sheath 1912 of between 0.053 and 0.093 inches, such as 0.053, 0.057, 0.061, 0.065, 0.069, 0.073, 0.077, 0.081, 0.085, 0.089, and 0.093 inches. If an 8 French size laser catheter is to be used with the laser catheter assembly, the inner liner 1996 can provide an inner diameter for the outer sheath 1912 of between 0.064 and 0.104 inches, such as 0.064, 0.068, 0.072, 0.076, 0.080, 0.084, 0.088, 0.092, 0.096, 0.100, and 0.104 inches. The inner liner 1996 can have a wall thickness of between 0.0002 and 0.0025 inches, such as 0.0005, 0.0007, 0.0009, 0.0011, 0.0013, 0.0015, 0.0017, 0.0019, 0.0021, 0.0023, and 0.0025.

[0259] Although FIG. 4 The pattern of pairs of attenuating members and intermediate layers is shown with the attenuating members 1968 located radially outward of the intermediate layers 1970, but the pattern of pairs of attenuating members and intermediate layers can be arranged with the attenuating members 1968 located radially inward of the intermediate layers 1970. With continued reference to FIG. 19 The outer sheath 1912 can not include the outer sleeve 1978, the inner liner 1996, or both, as doing so can reduce the overall cross-sectional diameter and / or size of the outer sheath 1912 and / or allow the outer sheath 1912 to have a greater number of alternating pairs of attenuating members 1968 and intermediate layers 1970.

[0260] FIG. 5 The outer sheath 1912 illustrated in the figures can replace any sheath discussed in the present disclosure and / or illustrated in any of the figures. FIGS. 5A-5FThe outer sheath illustrated in the diagram may replace any outer sheath used to treat a subject using any of the methods discussed and / or illustrated in the representative flowchart. For example, FIG. 6 The outer sheath shown in the image 1912 is replaceable. FIG. 19 The diagram in the middle is used for execution. FIG. 9A The representative flowchart illustrates the method of treating the subject with a sheath 250. FIG. 9B The outer sheath shown in the image 1912 is replaceable. FIG. 19 and FIG. 11 The diagram in the middle is used for execution. FIG. 19 The representative flowchart illustrates the method of treating the subject with a 250″ sheath. FIG. 12 The outer sheath 1912 shown in the diagram can be replaced and used for execution. FIG. 12A and FIG. 12B The representative flowchart illustrates the method of treating the subject with a protective sheath. FIG. 12B The outer sheath 1912 shown in the diagram can be replaced and used for execution. FIG. 13 The representative flowchart illustrates the method of treating the subject with a protective sheath. FIG. 13A The outer sheath shown in the image 1912 is replaceable. FIG. 13B , FIG. 13C , FIG. 13C , FIG. 15 '、 FIG. 19 , FIG. 17 , ​ , ​ and ​ The image shown in the middle is used for execution. ​ The representative flowchart illustrates the method of treating the subject with an outer protective sheath 1212. ​ The outer sheath shown in the image 1912 is replaceable. ​ , Figure 17A and Figure 18 The sheath 1212 is shown in the drawing.

[0261] use Figure 19 The outer sheath 1912 illustrated here, replacing the sheath discussed elsewhere in this disclosure, should increase the amplitude of the pressure wave transmitted through the sheath. Multiple pairs of attenuating members 1968 and the intermediate layer 1970 increase the reflection index of the pressure wave transmitted to the blood vessel without increasing the size of unwanted bubbles, thereby potentially improving the overall effectiveness of the treatment while enhancing patient safety.

[0262] While a significant portion of this disclosure relates to laser ablation catheters used in conjunction with sheath assemblies for performing CAD and PAD procedures, others besides these laser ablation catheters and sheath assemblies can be used to perform other types of medical and / or surgical procedures. Laser catheters typically transmit laser energy via an optical fiber housed within a relatively flexible tubular catheter inserted into a lumen of the body, such as a blood vessel, ureter, fallopian tube, or cerebral artery, to remove obstructions or restrictions within the lumen. Catheters used for laser angioplasty and other procedures may have a central channel or tube that receives a guidewire inserted into a body lumen (e.g., the vascular system) prior to catheter introduction. This guidewire facilitates the advancement and placement of the catheter into a selected portion of the body lumen for laser ablation of tissue.

[0263] In various aspects, embodiments, and configurations, this disclosure includes components, methods, processes, systems, and / or apparatuses substantially as depicted and described herein, including aspects, embodiments, configurations, sub-combinations, and subsets thereof. Upon understanding this disclosure, those skilled in the art will understand how to make and use these aspects, embodiments, and configurations. In various aspects, embodiments, and configurations, this disclosure includes providing devices and processes to improve performance, achieve simplicity, and / or reduce implementation costs without items not depicted and / or described herein; or in various aspects, embodiments, and configurations of this disclosure, this disclosure includes providing devices and processes to improve performance, achieve simplicity, and / or reduce implementation costs without such items that may have already been used in prior devices or processes.

[0264] The foregoing discussion of this disclosure has been presented for purposes of illustration and description. The foregoing is not intended to limit this disclosure to one or more forms disclosed herein. For example, in the preceding detailed description, various features of this disclosure have been combined in one or more aspects, embodiments, and configurations for the purpose of simplifying this disclosure. Features of aspects, embodiments, and configurations of this disclosure may be combined in alternative aspects, embodiments, and configurations other than those discussed above. This approach to disclosure should not be construed as reflecting an intention to require more features than expressly recited in each claim. Rather, as reflected in the following claims, the inventive aspect lies in fewer than all features of a single aspect, embodiment, and configuration of the foregoing disclosure. Therefore, the following claims are incorporated herein by reference, and each claim stands independently as a separate preferred embodiment of this disclosure.

[0265] Further, although the description of the present disclosure has included description of one or more aspects, embodiments, and configurations and some variations and modifications, other variations, combinations, and modifications in addition to those specifically set forth can occur to persons skilled in the art, based on the overall teachings of the present disclosure. It is therefore intended that the scope of the present disclosure be determined by the claims which have been appended, including any equivalents to which such claims are entitled, including substitutions, permutations, and / or equivalents to structures, functions, ranges, or steps specifically recited herein, whether or not such equivalents are disclosed herein, and without intent to dedicate any patentable subject matter to the public.

Claims

1. A catheter system, comprising: A laser guide tube includes a proximal end, a distal end, and at least one emitter disposed adjacent to said distal end; A sheath, configured to be disposed on the at least one transmitter and configured to receive a liquid medium, the sheath including a proximal end and a distal end, wherein the sheath includes a first layer forming a lumen, a plurality of pairs of attenuating members radially located outside the first layer, and an intermediate layer, wherein the attenuating members are made of a first material having a first thickness and a first hardness, and the intermediate layer is made of a second material having a second thickness and a second hardness, wherein the first hardness is greater than the second hardness. The sheath includes alternating attenuation members and an intermediate layer.

2. The catheter system according to claim 1, wherein, The first thickness and the second thickness are different.

3. The catheter system according to claim 1, wherein, The first thickness and the second thickness are equal.

4. The catheter system according to claim 1, wherein, The difference between the first hardness and the second hardness is Shore hardness 10D.

5. The catheter system according to claim 1, wherein, The difference between the first hardness and the second hardness is Shore hardness 20D.

6. The catheter system according to claim 1, wherein, The difference between the first hardness and the second hardness is Shore hardness 30D.

7. The catheter system according to claim 2, in, The laser catheter is configured to be positioned within the subject's blood vessels after the location of the calcified portion within the medial membrane of the subject's blood vessels has been determined. The sheath is configured to be positioned on the laser conduit located within the blood vessel of the subject; The sheath is configured to be positioned such that the attenuating member is positioned adjacent to a portion of the calcified portion within the media of the blood vessel; The laser conduit is configured to be positioned within the blood vessel such that the at least one emitter is positioned within the attenuation member and adjacent to a portion of the calcified portion within the media of the blood vessel. The sheath is configured to introduce a liquid medium into the sheath and into the at least one transmitter; and The at least one transmitter is configured to emit a plurality of light energy pulses into the liquid medium, wherein the plurality of light energy pulses are used to react with the liquid medium and generate a plurality of propagating laser-induced pressure waves that disrupt the calcified portions within the medial membrane, thereby improving the compliance of the blood vessel.

8. The catheter system according to claim 7, wherein, The sheath is configured to be repositioned such that the attenuation member is adjacent to another calcified portion within the middle membrane.

9. The catheter system according to claim 7, wherein, The laser conduit is configured to be repositioned within the sheath such that the at least one emitter is adjacent to another calcified portion within the middle membrane.

10. The catheter system according to claim 9, wherein, The laser guide is configured to be repositioned within the attenuation member.

11. The catheter system according to claim 7, wherein, The laser conduit is configured to be repositioned within the sheath.

12. The catheter system of claim 11, wherein, The laser guide is configured to be repositioned within the attenuation member.

13. The catheter system according to claim 7, wherein, The laser conduit and the sheath are configured to be removed from the blood vessel.

14. The catheter system according to claim 3, wherein, The catheter system also includes a guidewire; The guidewire is configured to be inserted into a vascular occlusion that passes through the blood vessels of the subject. The laser conduit is configured to be introduced into the blood vessel and located on the guidewire; The laser conduit is configured to ablate at least a portion of the vascular occlusion. The sheath is configured to be introduced into the blood vessel and located on the laser conduit; The sheath is configured to be positioned within the vessel such that the attenuating member is arranged radially adjacent to the calcified portion within the vessel. The laser conduit is configured to be positioned within the pulse vessel such that at least one emitter is positioned within the attenuation member and is radially adjacent to the calcified portion; The sheath is configured to introduce a liquid medium into the sheath and into the at least one transmitter; and The transmitter is configured to emit a plurality of light energy pulses from the at least one transmitter into the liquid medium, wherein the plurality of light energy pulses are used to react with the liquid medium and generate a plurality of propagating laser-induced pressure waves that destroy the calcified portion.

15. The catheter system according to claim 14, in, The laser conduit is configured to extend distally to the sheath and ablate another portion of the second vascular occlusion. The sheath is configured to be positioned within the blood vessel such that the attenuating member is arranged radially adjacent to the second calcified portion of the second blood vessel occlusion. The laser conduit is configured to be positioned within the pulse vessel such that the at least one emitter is positioned within the attenuation member and radially adjacent to the second calcified portion; and The plurality of light energy pulses are used to generate a plurality of propagating laser-induced pressure waves that destroy the second calcified portion.

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