Surface manipulative balloon catheter system and method

Abstract

The invention provides a device and methods useful in manipulating the internal surface of a vessel. The device includes a catheter with a flexible membrane portion, which may include a compression member configured to rotate around an axis and / or translate along a second axis. The flexible membrane portion is in fluid communication with a lumen within an elongate member. The flexible membrane portion is configured to transition between deflated and inflated positions. Depending on the position of the flexible membrane portion, the compression member may transition between a retracted and an extended position. The methods include using a device within a vessel to break up and / or smooth deposits on the surface of the vessel to increase the flow of fluids with the vessel and / or facilitate the transfer of a drug to the surface of the vessel.

Description

SURFACE MANIPULATIVE BALLOON CATHETER SYSTEM AND METHODCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 678,752, filed on August 2, 2024, titled “Surface Manipulative Balloon Catheter System and Method, the contents of which are incorporated herein by reference in its entirety.BACKGROUND

[0002] The present disclosure relates generally to medical devices and more particularly the present disclosure relates to catheters and catheter systems.

[0003] Peripheral Artery Disease (PAD) is a prevalent circulatory condition that affects the arteries carrying blood away from the heart to the limbs, commonly the legs. It occurs due to a gradual build-up of plaque within the arteries, leading to a narrowing of the blood vessels and reduced blood flow. As a result, individuals with peripheral artery disease might experience symptoms like cramping, pain, or numbness in their legs, especially during physical activity. If left untreated, peripheral artery disease can have serious consequences, including impaired wound healing, an increased risk of heart attack or stroke and even amputation.SUMMARY

[0004] At least one implementation relates to a catheter, including; a first elongate member spanning between a first end and a second end and defining a first lumen therethrough; a second elongate member within the lumen and spanning between a third end and a fourth end, and defining a second lumen therethrough; a flexible membrane portion provided at the first end of the first elongate member and in fluid communication with the lumen, the flexible membrane portion including a flexible membrane wall enclosing a flexible membrane volume and configured to selectively transition between a deflated position and a fully inflated position; and an expandable member including: a third elongate member within the flexible membrane volume and spanning between a fifth end and a sixth end, the third elongate member configured to rotate around a first axis and / or translate along the first axis within the flexible membrane volume; and a compression member coupled to the third elongate member and configured to rotate around a second axis offset from the first axis, where the second axis rotates around the first axis when the third elongate member rotates around the first axis, the compression member biased toward an extended positionwhere the second axis is spaced from the first axis by a first distance; where, when the flexible membrane portion is in the deflated position the compression member is in a retracted position where the second axis is spaced from the first axis by a second distance that is less than the first distance.

[0005] In some implementations, when the flexible membrane portion is in the inflated position and the motor rotates the third elongate member around the first axis, the compression member is biased into tractive contact with the flexible membrane wall and rotates around the second axis in a first rotational direction, and rotates around the first axis in a second rotational direction opposite the first rotational direction.

[0006] In some implementations, the catheter further includes a motor fixedly coupled to the second elongate member and operably coupled to the expandable member; where the fifth end of the third elongate member is coupled to the motor.

[0007] In some implementations, the catheter includes a bushing (or bearing) portion provided at a distal end of the flexible membrane portion; and where the sixth end is received by the bushing portion. In some implementations, the flexible membrane wall is coated in a drug. In some implementations, the drug is Paclitaxel. In some implementations, the catheter includes an electrical conduit within the second lumen and operably coupled to the motor. In some implementations, the catheter includes a motor fixedly coupled to the third end of the second elongate member. In some implementations, the catheter includes a thrust bearing coupled to the third elongate member between the fifth end and an output shaft of the motor. In some implementations, the third elongate member includes an axial portion extending along the first axis and an eccentric portion that supports the compression member. In some implementations, the catheter includes a handle coupled to the second end of the first elongate member and the fourth end of the second elongate member.

[0008] In some implementations, the catheter includes a motor fixedly coupled to the handle and the second elongate member. In some implementations, the motor is configured to rotate the second elongate member within the lumen and relative to the handle and the first elongate member. In some implementations, the first elongate member and the second elongate member are made of a flexible material.

[0009] In some implementations, the catheter includes a collar coupled between the first elongate member and the second elongate member at the first end of the first elongate member, the collar including a multiple of fluid channels that permit passage of fluids therethrough, and where the collar supports the third end of the second elongate member within the lumen and substantially aligns the first axis and a longitudinal axis of the first elongate member. In some implementations, the catheter includes a seal provided at the third end of the second elongate member that fluidly separates an internal volume of the second lumen from the flexible membrane volume.

[0010] At least one implementation relates to a method, including: inserting a catheter with a flexible membrane portion within a vessel having a flow orifice constricted by debris; partially expanding the flexible membrane portion; operating a motor to rotate an expandable member to break up calcifications and hard deposits within the vessel; fully inflating the flexible membrane portion and operating the motor to rotate the expandable member to smooth the surface of the debris and improve a contact area between a flexible membrane wall of the flexible membrane portion and a surface of the debris; deflating and subsequently retracting the flexible membrane portion from the vessel.

[0011] Some implementations relate to a method, wherein the catheter includes: a first elongate member spanning between a first end and a second end and defining a first lumen therethrough; and a second elongate member within the first lumen and spanning between a third end and a fourth end, and defining a second lumen therethrough; and wherein the flexible membrane portion is provided at the first end of the first elongate member and is in fluid communication with the first lumen, the flexible membrane portion including a flexible membrane wall enclosing a flexible membrane volume and configured to selectively transition between a deflated position and an inflated position; and wherein the expandable member includes: a third elongate member within the flexible membrane volume and spanning between a fifth end and a sixth end, the third elongate member configured to rotate around a first axis or translate along a first axis within the flexible membrane volume; and a compression member coupled to the third elongate member and configured to rotate around a second axis offset from the first axis, wherein the second axis rotates around the first axis when the third elongate member rotates around the first axis, the compression member biased toward an extended position (e.g., smoothing position) wherein the second axis is spaced from the first axis by a first distance; and wherein, when the flexible membrane portion is in the deflated position the compression member is in a retracted position wherein the second axis is spaced from the first axis by a second distance that is less than the first distance.

[0012] Some implementations relate to a method, wherein when the flexible membrane portion is in an inflated position and a motor rotates the third elongate member around the first axis, the compression member is biased into contact with the flexible membrane wall and rotates around the second axis in a first rotational direction, and rotates around the first axis in a second rotational direction opposite the first rotational direction.

[0013] Some implementations relate to a method, wherein the catheter further includes a motor fixedly coupled to the second elongate member and operably coupled to the expandable member; wherein the fifth end of the third elongate member is coupled to the motor.

[0014] Some implementations relate to a method, wherein the catheter further includes a bushing or bearing portion provided at a distal end of the flexible membrane portion; and wherein the sixth end is received by the bushing or bearing portion.

[0015] Some implementations relate to a method, wherein the flexible membrane wall is coated in a drug.

[0016] Some implementations relate to a method, wherein the catheter further includes an electrical conduit within the second lumen and operably coupled to the motor.

[0017] Some implementations relate to a method, wherein the catheter further includes a thrust bearing coupled to the third elongate member between the fifth end and an output shaft of the motor.

[0018] Some implementations relate to a method, wherein the third elongate member includes an axial portion extending along the first axis and an eccentric portion that supports the compression member.

[0019] Some implementations relate to a method, further including a handle coupled to the second end of the first elongate member and the fourth end of the second elongate member.

[0020] Some implementations relate to a method, wherein the first elongate member and the second elongate member are made of a flexible material.

[0021] Some implementations relate to a method, wherein the catheter further includes a collar coupled between the first elongate member and the second elongate member at the first end of the first elongate member, the collar including a plurality of fluid channels that permit passage offluids therethrough, and wherein the collar supports the third end of the second elongate member within the first lumen and substantially aligns the first axis and a longitudinal axis of the first elongate member.

[0022] Some implementations relate to a method, wherein the catheter further includes a seal provided at the third end of the second elongate member that fluidly separates an internal volume of the second lumen from the flexible membrane volume.

[0023] Some implementations relate to a method, wherein the flexible membrane portion is a balloon; wherein the expandable member is a balloon implement; wherein the third elongate member is a resilient wire; wherein the compression member is a compression member; wherein the first axis is a first axis; wherein the second axis is a roller axis; wherein the flexible membrane volume is a balloon volume; and wherein the flexible membrane wall is a balloon wall; and wherein the second axis is eccentrically located relative to the first axis.

[0024] This summary is illustrative only and is not intended to be in any way limiting. Other aspects, inventive features, and advantages of the devices or processes described herein will become apparent in the detailed description set forth herein, taken in conjunction with the accompanying figures, wherein like reference numerals refer to like elements.BRIEF DESCRIPTION OF THE DRAWINGS

[0025] FIG. 1 is a depiction of a catheter 100, according to an exemplary implementation;

[0026] FIG. 2 is a section view of the catheter 100 taken along line A-A of FIG. 1, according to some implementations;

[0027] FIG. 3 is a section view of the catheter 100 taken along line B-B of FIG. 2, according to some implementations;

[0028] FIG. 4 is a section view of the catheter 100 in a deflated position 126 taken along line B-B of FIG. 2, according to some implementations;

[0029] FIG. 5 is a section view of the catheter 100 in a partially inflated position 128 taken along line B-B of FIG. 2, according to some implementations;

[0030] FIG. 6 is a depiction of the catheter 100 within the lumen of a diseased vessel 10, according to some implementations;

[0031] FIG. 7 is a depiction of the catheter 100 within the lumen of the diseased vessel 10, according to some implementations;

[0032] FIG. 8 A is an image of a flexible membrane wall 122 including a drug coating, according to some implementations;

[0033] FIG. 8B is a depiction of a scanning electron microscope, according to some implementations;

[0034] FIG. 8C is an image of the flexible membrane wall 122 including crystallized paclitaxel taken by a scanning electron microscope at 2500x magnification, according to some implementations ;

[0035] FIG. 9 is a depiction of a vessel 10 with a lesion 12 having nodular calcium and a depiction of a vessel 10 having smooth calcium, according to some implementations;

[0036] FIG. 10A is an image of a vessel 10 having a lesion 12 having a nodular surface, according to some implementations;

[0037] FIG. 10B is a depiction of a vessel 10 having a lesion 12 having a nodular surface, according to some implementations;

[0038] FIG. 10C is a detail view of the vessel 10 of FIG. 10B, according to some implementations;

[0039] FIG. 10D is an image of a vessel 10 having a lesion 12 having a smooth surface, according to some implementations;

[0040] FIG. 10E is a depiction of a vessel 10 having a lesion 12 having a smooth surface, according to some implementations;

[0041] FIG. 10F is a detail view of the vessel 10 of FIG. 10E, according to some implementations;

[0042] FIG. 11A is a depiction of a vessel 10 being treated with flexible membrane angioplasty, and a stenotic vessel 10 having reduced patency, according to some implementations;

[0043] FIG. 1 IB is a depiction of a vessel 10 being treated with the catheter 100, and a vessel 10 featuring restored patency, according to some implementations;

[0044] FIG. 12 is a flow diagram of treating a patient having a vascular disease using the catheter 100, according to some implementations;

[0045] FIG. 13 is a flow diagram of percutaneous vascular intervention, according to some implementations;

[0046] FIG. 14A is an image of a drug-coated lesion having a “minimal” drug distribution; according to some implementations;

[0047] FIG. 14B is an image of a drug-coated lesion 12 having a rough surface, with a grading scale overlaid depicting drug coverage classification (i.e., minimal, good, moderate, excellent), according to some implementations;

[0048] FIG. 14C is an image of a drug-coated lesion having a “good” drug distribution; according to some implementations;

[0049] FIG. 14D is an image of a drug-coated lesion having a “moderate” drug distribution; according to some implementations;

[0050] FIG. 14E is an image of a drug-coated lesion 12 having an uneven surface, with a grading scale overlaid depicting drug coverage classification (i.e., minimal, good, moderate, excellent), according to some implementations;

[0051] FIG. 14F is an image of a drug-coated lesion having a “excellent” drug distribution; according to some implementations;

[0052] FIG. 15 is a bar chart of the classes of the sectors shown in FIG. 14B and FIG. 14E, where the uneven surface (FIG. 14B) bars are indicated by the label “N” and the smooth surface (FIG. 14E) bars are indicated by the label “S”, according to some implementations.DETAILED DESCRIPTION

[0053] Before turning to the figures, which illustrate the exemplary implementations in detail, it should be understood that the present application is not limited to the details or methodology set forth in the description or illustrated in the figures. It should also be understood that the terminology is for the purpose of description only. Like reference numerals in the figures may represent and refer to the same or similar element, feature, or function.

[0054] Described herein are systems and methods for treating vascular diseases and enhancing delivery of drug (e.g., an anti -proliferative agent such as Paclitaxel, Sirolimus, etc.) from drugeluting devices (e.g., drug-coated balloons, drug-coated vascular balloons, drug-eluting balloons) to affected portions (e.g., lesion 12) of a blood vessel 10 (e.g., a diseased artery). The systems and methods described herein may be used to treat, for example, peripheral artery disease, ischemia, and other vascular diseases.

[0055] Peripheral Artery Disease (PAD) poses a significant global health challenge. PAD is typically caused by atherosclerosis, which leads to stenosis or blockage in major vessels supplying the lower extremities. For example, below-the-knee arterial disease is seen in the majority (more than 50%) of chronic limb-threatening ischemia (CLTI) patients. Below-the-knee arterial disease tends to be diffuse, severely calcified, and involves long-segment chronic total occlusions. CLTI patients often present with non-healing wounds of the foot with possible secondary infection and gangrene, and some will undergo a major amputation within 1 year of presentation. The aim of treatment of PAD patients is to prevent amputation and / or death by restoring blood flow to heal wounds.

[0056] Percutaneous vascular intervention (PVI) involving guidewire insertion followed by balloon angioplasty (e.g., plain balloon angioplasty, a.k.a. POBA) is often used to treat PAD. However, treated vessels stenose or occlude again in -70% of cases in as few as three months after treatment, as shown in FIG. 11 A. The integration of drug-coated balloons covered with one or more drugs (e.g., paclitaxel) can reduce smooth muscle proliferation and consequential restenosis in peripheral arteries, as shown in FIG. 1 IB. However, conventional drug-coated devices have many shortcomings, including poor efficiency of the drug being delivered to the vessel wall, which can lead to distal embolization of the drug and higher amputation rates. For example, embolized drug entering distal circulation can lead to a "slow flow" phenomenon post-DCB use, which may be caused by the occlusion of distal arterioles and increased outflow resistance due to drug (e.g., paclitaxel crystals) that do not successfully transfer to the vessel wall. For example, the solid particles of an embolized portion of the drug coating can incite local tissue ischemia, inflammation, and hypoxia. Some studies of conventional drug-coated balloons have shown that as little as 10% of the drug reaches the diseased portion of the blood vessel, and the remainder of the drug is carried downstream.

[0057] A technical challenge in treating PAD patients via DCBs is the substantial variation in plaque morphology between patients, which directly impacts drug delivery. For example, unevensurfaces (e.g., ridged surfaces, pitted surfaces, lumpy surfaces, bumpy surfaces, etc.) of the affected portion of a diseased blood vessel limit the effectiveness of the DCB. See, e.g., FIGS. 9- 10. Moreover, the calcified nature of some target vessels exacerbates the shortcomings of DCBs. For example, highly irregular calcified vessels can cause variable contact pressure between the balloon and the vessel wall, hindering effective drug transfer.

[0058] Some PVI approaches use orbital atherectomy or other atherectomy devices (e.g., directional, laser, rotational) to core out the lesion 12 (e.g., plaque, calcified plaque, atheromatous plaque, plaque deposits, deposits, blockage, etc.) to prepare the surface for the drug-coated balloon. However, orbital atherectomy and other atherectomy devices increase the possibility of distal embolization due to the bits of plaque (e.g., shavings, trimmings, etc.) detaching from the deposit and entering the distal circulation. Further shortcomings of orbital atherectomy and other atherectomy devices include disrupting the intimal layer of the vessel wall and creating a thrombogenic surface, which can lead to increased re-occlusion rates.

[0059] The systems and methods described herein provide solutions to these and other technical problems through a catheter 100 having a compression member (e.g., compression member, rotating drill bit) within the drug-coated balloon that facilitates smoothing the blood vessel surface from within the balloon, and driving the drug-coated balloon wall into contact with the blood vessel surface. Advantageously, the catheter 100 provides a user the flexibility to manipulate (e.g., smooth, re-shape, etc.) the surface of a vessel while avoiding abrasion and also preventing portions of the lesion 12 from embolizing into distal circulation.

[0060] Referring to FIGS. 1-15, a catheter 100 (e.g., balloon catheter) includes a first elongate member 102 (e.g., tube, pipe, duct, etc.) spanning between a first end 104 (e.g., distal end) and a second end 106 (e.g., proximate end) and defining a first lumen 108 therethrough. In some implementations, the catheter 100 includes a second elongate member 110 within the first lumen 108 and spanning between a third end 112 (e.g., distal end) and a fourth end 114 (e.g., proximate end). In some implementations, the second elongate member 110 defines a second lumen 116 therethrough.

[0061] In some implementations, the catheter 100 includes a flexible membrane portion 120 (e.g., balloon portion) provided at the first end 104 (e.g., distal end) of the first elongate member 102. In some implementations, the flexible membrane portion 120 is in fluid communication with the first lumen 108. In some implementations, the flexible membrane portion 120 includes a flexiblemembrane wall 122 (e.g., balloon wall) enclosing a flexible membrane volume 124 (e.g., balloon volume). In some implementations, the flexible membrane portion 120 is configured to selectively transition between a deflated position 126 (see, e.g., FIG. 4) and an inflated position 127 (see, e.g., FIGS. 1-3). In some implementations, the deflated position 126 is achieved when the flexible membrane portion 120 is in a partial vacuum. In some implementations, the flexible membrane portion 120 is in a partially inflated position 128 between the deflated position 126 and the inflated position 128 (see, e.g., FIG. 5).

[0062] In some implementations, the flexible membrane portion 120 includes an expandable member 140 (e.g., a balloon implement, etc.). In some implementations, the expandable member 140 includes an elongate member 142 (e.g., a resilient wire) within the flexible membrane volume 124 and spans between a fifth end 144 (e.g., proximal end) and a sixth end 146 (e.g., distal end). In some implementations, the elongate member 142 is configured to rotate around a first axis 148 (e.g., a wire axis) within the flexible membrane volume 124.

[0063] In some implementations, a compression member 150 (e.g., roller) is coupled to the elongate member 142. In some implementations, the compression member 150 is rotatably coupled to the elongate member 142 and is configured to rotate around a second axis 152 (e.g., roller axis, compression member axis, etc.) eccentrically located relative to the first axis 148. In some implementations, the second axis 152 rotates around the first axis 148 when the elongate member 142 rotates around the first axis 148. In some implementations, the compression member 150 is biased toward an extended position 154 (e.g., smoothing position) where the second axis 152 is spaced from the first axis 148 by a first distance 158. In some implementations, shown in FIG. 4, when the flexible membrane portion 120 is in the deflated position 126 the compression member 150 is in a retracted position 160 wherein the second axis 152 is spaced from the first axis 148 by a second distance 162. In some implementations, the second distance 162 is less than the first distance 158. For example, in FIGS. 2-3, the second axis 152 is spaced from the first axis 148 by a first distance 158, and in FIG. 4 is spaced from the first axis 148 by a second distance 162.

[0064] In some implementations, when the flexible membrane portion 120 is in the inflated position 127, and a motor 130 rotates the elongate member 142 around the first axis 148, the compression member 150 is biased into tractive contact with the flexible membrane wall 122 and rotates around the second axis 152 in a first rotational direction 164, and rotates around the first axis 148 in a second rotational direction 166 opposite the first rotational direction 164. See, e.g., FIG. 3.

[0065] In some implementations, when the drug-coated flexible membrane portion 120 is partially inflated, the compression member 150 (e.g., roller, drill bit, motorized drill bit, etc.) within the flexible membrane portion 120 (e.g., balloon) within the vessel 10 takes action, pummeling inside the flexible membrane portion 120 (e.g., balloon) the surrounding calcified wall 12, according to some implementations. For example, the expandable member 140 may be operated in a pummel mode. In the pummel mode the compression member 150 may impart shockwaves or striking forces into the lesion 12 (e.g., calcified plaque). For example, the compression member 150 may be driven to strike the flexible membrane wall 122, which may cause the flexible membrane wall 122 to transfer the strike energy to the vessel wall. The pummeling of the lesion 12 may influence the brittle portions (e.g., calcified portions) of the lesion 12 to fracture. In some implementations, the compression member 150 may be operated in a rolling mode. In the rolling mode, the compression member 150 is driven into contact with the interior surface of the flexible membrane (e.g., balloon) and provides an increased contact pressure between the exterior surface of the flexible membrane and the vessel wall by smoothly rolling along the interior of the flexible membrane and indirectly (via the flexible membrane wall 122) along the lesions and vessel wall. For example, the compression member 150 may smoothly roll around the perimeter of the lumen of the vessel 10 to smooth the surface of the lesion 12 and press the drug-coating into contact with the surface of the lesion 12. In some implementations, the expandable member 140 is operated in the pummel mode and subsequently the rolling mode. See, e.g., FIGS. 6-7.

[0066] In some implementations, the catheter 100 includes a motor 130 (e.g., electric motor, DC motor, AC motor, brushless motor, micromotor, pneumatic motor, hydraulic motor, etc.) operably coupled to the expandable member 140. In some implementations, the motor 130 is fixedly coupled to the second elongate member 110. In some implementations, the fifth end 144 of the elongate member 142 is coupled to the motor 130. For example, the fifth end 144 of the elongate member 142 may be coupled to the output shaft of the motor 130. In some implementations, the motor 130 includes a transmission (e.g., gearbox, thrust bearing, planetary gears, etc.).

[0067] In some implementations, the catheter 100 includes a bushing (and / or bearing) portion 131 provided at a distal end 125 of the flexible membrane portion 120. In some implementations, the sixth end 146 is received by the bushing portion 131.

[0068] In some implementations, the flexible membrane wall 122 is coated in an anti-proliferative agent. In some implementations, the anti-proliferative agent prevents neointimal hyperplasia. In some implementations, the anti-proliferative agent kills proliferating smooth muscle cells aftertreating the vessel (e.g., ballooning, rolling, p mmeling, etc.), thereby preventing neointimal hyperplasia and re-narrowing post-procedure. In some implementations, the anti-proliferative agent is a chemotherapeutic drug. In some implementations, the chemotherapeutic drug is at least one of paclitaxel and / or sirolimus. In some implementations, at least a portion of the outer surface of the flexible membrane wall 122 is coated with the anti-proliferative agent. In some implementations, the flexible membrane wall 122 is at least partially coated with Ethylene diamine tetra-acetic acid (EDTA).

[0069] In some implementations, the flexible membrane wall 122 includes a textured portion 170. See, e.g., FIG. 1. In some implementations, the textured portion 170 includes a raised pattern (e.g., dots, ribs, linear patterns, lattice, circular patterns, or combinations thereof). In some implementations, the textured portion 170 enhances the local contact pressure at the raised portions of the pattern. For example, the textured portion 170 may guide the drug-coating to penetrate the surface of the lesion 12 and / or be deposited into a recess (e.g., pockets, valleys, channels, etc.) formed by the textured portion 170 into the surface of the lesion 12. In some implementations, the patterns (e.g., micropatterns) improve the transfer efficiency of drug compounds to the vascular tissue. In some implementations, the textured portion 170 is configured to dimple the surface of the lesion 12 and enhance the flow behavior (e.g., boundary layer) of the fluid (e.g., blood) flowing within the vessel. In some implementations, the textured portion 170 forms pockets into the surface of the lesion 12 and the drug of a drug-coating occupies the pockets. In some implementations, the textured portion 170 increases the surface area of potential drug-binding sites of the lesion 12. In some implementations, the textured portion 170 textures the surface of the lesion 12 to prevent at least a portion of the drug deposited onto the surface of the lesion 12 from being washed away from the lesion 12 by blood flow.

[0070] In some implementations, the catheter 100 is configured to enhance compliance, even out plaque components, and make the vessel wall more amenable to further treatments (e.g., ballooning, DCB ballooning, or stent placement). In some implementations, the compression member of the catheter 100 massages the tissues of the vessel and / or the tissues proximate the vessel to improve the patency of the lumen of the diseased vessel. In some implementations, the flexible membrane wall 122 is not drug-coated. For example, the flexible membrane portion 120 may be a non-coated balloon. In some implementations, a drug-coated balloon may be applied during the procedure or in a subsequent procedure.

[0071] In some implementations, the catheter 100 includes an electrical conduit within the second lumen 116 and is operably coupled to the motor 1 0. For example, the electrical conduit may be electrically coupled to a power supply (e.g., via power cable(s)), and / or the controller 200 (e.g., via data cable(s)).

[0072] In some implementations, the catheter 100 includes a motor 130 fixedly coupled to the third end 112 of the second elongate member 110.

[0073] In some implementations, the catheter 100 includes a thrust bearing coupled to the elongate member 142 between the fifth end 144 and an output shaft of the motor 130. For example, the thrust bearing may support axial forces in the direction of the first axis 148.

[0074] In some implementations, the elongate member 142 includes an axial portion extending along the first axis 148 and an eccentric portion that supports the compression member 150.

[0075] In some implementations, the catheter 100 includes a handle 180 coupled to the second end 106 of the first elongate member 102 and the fourth end 114 of the second elongate member 110.

[0076] In some implementations, the catheter 100 includes a motor 130 fixedly coupled to the handle and the second elongate member 110.

[0077] In some implementations, the motor 130 is configured to rotate the second elongate member 110 within the first lumen 108 and relative to the handle 180 and the first elongate member 102.

[0078] In some implementations, at least a portion of the first elongate member 102 and / or at least a portion of the second elongate member 110 are at least partially made of a flexible material (e.g., a flexible polymer, a flexible composite material).

[0079] In some implementations, the catheter 100 includes a collar 190 coupled between the first elongate member 102 and the second elongate member 110 at the first end 104 of the first elongate member 102. See, e.g., FIG. 5. In some implementations, the collar 190 includes multiple fluid channels that permit passage of fluids therethrough. In some implementations, the collar 190 supports the third end 112 of the second elongate member 110 within the first lumen 108 and substantially aligns the first axis 148 and a longitudinal axis of the first elongate member 102.

[0080] In some implementations, the catheter 100 includes a seal provided at the third end 112 of the second elongate member 110. In some implementations, the seal fluidly separates an internal volume of the second lumen 116 from the flexible membrane volume 124.

[0081] In some implementations, the catheter 100 includes a deployable drug-eluting buttress. For example, the buttress may be coated with Paclitaxel. In some implementations, the buttress is deployed proximate to the surface of the deposit and is subsequently rolled and pressed into contact with the deposit via the compression member 150 operating in the rolling mode. In some implementations, the buttress includes a resilient material configured to bias the buttress toward an extended position that, when released by the catheter 100, holds the buttress against the lesion 12. In some implementations, the buttress is bioabsorbable. For example, the buttress may biodegrade into biocompatible bioabsorbable degradation products instead of, for example, persisting and being surgically retrieved in a subsequent procedure.

[0082] In some implementations, the catheter 100 includes a trap (e.g., net, webbing, etc.) proximate to the flexible membrane portion that is configured to capture particulate matter released during treatment (if any) such that the particulate matter does not pass. For example, if at least a portion of the deposit is freed from the vessel wall during treatment, the trap may capture the at least a portion of the lesion 12 and facilitate removal of the at least a portion of the lesion 12 as the catheter 100 is retracted from the vessel 10.

[0083] In some implementations, the catheter 100 includes a controller 200. The controller 200 can be deployed on the same or different computing systems.

[0084] The controller 200 includes a processing circuit 202 that is communicably coupled to communications circuit 204 such that the processing circuit 202 can send and receive data via communications circuit 204, according to some implementations. In some implementations, the communications circuit 204 facilitates communications between the controller 200 and the cloud (e.g., one or more network-based services). In some implementations, the communications circuit 204 is or includes wired or wireless communications interfaces (e.g., jacks, transmitters, receivers, antennas, transceivers, wire terminals, etc.).

[0085] In some implementations, the processing circuit 202 includes a processor 206 and a memory 208. The processor 206 can be implemented as a general purpose processor, one or more field programmable gate arrays (FPGAs), a group of processing components, an applicationspecific integrated circuit (ASIC), or other suitable electronic processing components. In some implementations, the processor 206 is a or includes an advanced RISC machine (ARM) based processor.

[0086] The memory 208 can be or include one or more devices (e.g., RAM, ROM, Flash memory, eROM, SSD storage, HDD storage, etc.) for storing data and / or computer code, instructions, for completing or facilitating the various processes, layers and modules described herein. In some implementations, the memory 208 is or includes volatile memory or non-volatile memory. The memory 208 can include database components, object code components, script components, or other instruction structures for supporting the various activities, tasks, and information structures described herein. In some implementations, memory 208 is communicably connected to processor 206 via the processing circuit 202 and includes computer code for executing (e.g., by the processing circuit 202 and / or the processor 206) one or more processes described herein.

[0087] In some implementations, the controller 200 may be operably coupled to a user interface 210. The user interface 210 may include one or more input devices (e.g., button, knob, keypad, joystick, microphone, camera, touch-sensitive surface, etc.) and one or more output devices (e.g., screens, lights, speakers, haptic-feedback device, etc.). The controller 200 may selectively display information or receive instructions regarding the operation of one or more sensors or actuators (e.g., motor 130), via the user interface 210.

[0088] In some implementations, the catheter 100 provides a user the flexibility to achieve plaque modification and enhanced vessel compliance while providing a protective shield for the endothelium via the flexible membrane wall 122. For example, the flexible membrane wall 122 may shield the endothelium from tractive forces. The flexible membrane wall 122 may prevent the compression member 150 from stripping the endothelium and distal embolization. In some implementations, the catheter 100 having a compression member within the flexible membrane volume 124, when operated in the rolling mode, provides a continuous rolling action (e.g., a radial pressure that travels around the longitudinal axis of the vessel) that significantly increases the contact pressure between the drug-coated surfaces of the flexible membrane and the vessel wall to facilitate improved drug transfer efficiency.

[0089] In some implementations, the catheter 100 is deployed to improve vessel conditions on rough surfaces of the deposit (e.g., nodular calcified lesions), which can not only increase permeability but also physically enhance drug transfer via DCBs. Smoothing the vessel wall viathe catheter 100 by, for example, operating the expandable member 140 in the pummel mode and / or rolling mode improves the coverage and quantity of drug transferred to the vessel wall.

[0090] In some implementations, the primary delivery mechanism of the drug-coated balloon is achieved by mechanically forcing the drug or the drug-carrying coating into the vascular wall during the treatment. For example, the drug or the drug-carrying coating may be mechanically forced into the vascular wall when the compression member is operated in the pummel mode and / or the rolling mode.

[0091] Referring to FIG. 13, a process 300 for percutaneous vascular intervention is shown, according to some implementations. The process 300 can be performed using the catheter 100. In some implementations, the process 300 begins with a step 302. In some implementations, the process 300 begins with a step 308.

[0092] In a step 302, the process 300 includes grouping patients based on a plaque type (e.g., plaque composition, plaque morphology, plaque heterogeneity, etc.). For example, the grouping may define multiple patient groups based on plaque type, according to some implementations. For example, the multiple groups may include a first group based on a first plaque type, and a second group based on a second plaque type different than the first type. In some implementations, the memory 208 maintains a database including the groupings. In some implementations, the grouping is based on an MRI histology protocol capable of identifying both hard (calcium, dense collagen) and soft (thrombus, fat, microchannels) lesion properties. In some implementations, the MRI histology protocol incorporates ultrashort echo time and fat-suppressed Steady State Free Precession flow-independent angiography sequences. In some implementations, the ultrashort echo time and fat- suppressed Steady State Free Precession flow-independent angiography sequences generate MRI-histology images that enable the differentiation of hard versus soft plaque components, determination of the degree of stenosis, and characterization of hard plaque components' morphology (concentric, eccentric, central, nodular). In some implementations, the MRI scanner is a 3T MRI scanner, giving results such as that shown in FIG. 12. In some implementations, the grouping is based on measured vessel diameters at the lesion site and calcium distribution over the target lesion. In some implementations, when a patient has undergone prior vascular imaging (such as computed tomography angiography, digital subtraction angiography, clinical MRI, or ultrasound), the imaging datasets are retrieved and analyzed to gather further details about the lesion 12. For example, the imaging datasets may be retrieved from a databasemaintained in the memory 208. In some implementations, the process 300 continues with a step 304.

[0093] In step 304, the process 300 includes matching a subject patient to a group of the multiple groups, according to some implementations. In some implementations, the matching is determined based at least partially on a comparison between an MRI result of the subject patient and MRI results typical of the multiple groups. In some implementations, the matching is performed by a matching module maintained in the memory 208. In some implementations, the process 300 continues with a step 306.

[0094] In step 306, the process 300 includes personalizing treatment for the subject patient based on the matching, according to some implementations. In some implementations, step 306 is or includes tailoring device selection (e.g., balloon size, balloon shape, roller size, roller shape, etc.) based on the matching. In some implementations, the user interface 210 is configured to display a message regarding the device selection based on the matching. In some implementations, the process 300 continues with a step 308.

[0095] In step 308, the process 300 includes inserting a flexible membrane portion into a diseased vessel, according to some implementations. In some implementations, step 308 is or includes inserting a flexible membrane portion 120 within the lumen of a vessel 10 having reduced patency. In some implementations, the drug-coated flexible membrane of the catheter 100 includes a multidirectional rotating compression member 150 within the flexible membrane portion 120. In some implementations, the flexible membrane portion 120 is inserted into human-diseased below- the-knee arteries. In some implementations, the flexible membrane portion 120 is inserted into popliteal and tibial arteries. In some implementations, the process 300 continues with a step 310.

[0096] In step 310, the process 300 includes partially inflating the flexible membrane near the target portion (e.g., lesion 12, according to some implementations. In some implementations, step 310 is or includes partially inflating the balloon to 2 - 4 atmospheres of pressure. In some implementations, the controller 200 is configured to regulate the pressure within the flexible membrane. For example, the controller 200 may selectively operate a pump and / or pressure release valve to achieve a setpoint pressure within a tolerance. In some implementations, the process 300 continues with a step 312.

[0097] In step 312, the process 300 includes operating the compression member in the pummel mode, according to some implementations. In some implementations, step 312 is or includes operating a motor 130 to cause the compression member 150 to strike the walls of the balloon, and thereby impart shockwaves and striking forces into the lesion 12 of the diseased vessel 10. In some implementations, step 312 is or includes fracturing calcified portions of the lesion 12. In some implementations, while the drug-coated flexible membrane portion 120 is being partially inflated to a first pressure (2-4 atmospheres), a motorized compression member within the flexible membrane within the vessel takes action, pummeling inside the flexible membrane the surrounding calcified wall. The compression member, when operating in the pummel mode, effectively breaks down the calcium deposits and avoids harming the protective endothelium. Additionally, the compression member 150 operating in the pummel mode reduces the likelihood of distal embolization. For example, the flexible membrane wall 122 can prevent the compression member 150 from imparting tractive forces onto the surface of the lesion, reducing the likelihood of the compression member 150 generating shavings from the lesion that could be embolized into the downstream circulation. In some implementations, the flexible membrane wall 122 maintains a retention pressure on the lesion 12 during the pummel mode to support the lesion 12 and prevent distal embolization. In some implementations, the below-the-knee arteries include nodular calcium. When the compression member 150 is operated in the pummel mode, the nodular calcium is fractured, allowing for the restoration of the patency of the lumen of the diseased artery 10. In some implementations, the controller 200 includes a mode manager maintained in memory 208 that selectively operates the motor 130 in the pummel mode. In some implementations, the pummel mode includes rapidly varying the distance 158 and / or the speed of the motor 130 to knock the compression member 150 around and into the flexible membrane wall 122 and vessel wall. In some implementations, the process 300 continues with a step 314. In some implementations, the process 300 continues with a step 316.

[0098] In step 314, the process 300 includes inflating the flexible membrane portion 120, according to some implementations. For example, the flexible membrane portion 120 may be inflated to 2-4 atmospheres of pressure. In some implementations, the flexible membrane portion 120 is inflated to a greater pressure than in step 310. In some implementations, the process 300 continues with a step 316.

[0099] In step 316, the process 300 includes operating the expandable member 140 in a rolling mode, according to some implementations. In some implementations, step 316 is or includesoperating a motor 130 to drive the expandable member 140 to smooth the surface of the lesion 12. In some implementations, step 316 is or includes rotating one or more compression members 150 around the first axis 148. In some implementations, step 316 includes rolling, by the compression member 150, the flexible membrane wall 122 onto the surface of the lesion 12 and / or depositing the drug of the drug-coating onto the surface of the lesion 12 by rolling the drug -coating onto the surface of the lesion 12. In some implementations, the catheter 100 is operated in the compression member mode to transition a nodular peripheral artery plaque morphology toward a smooth surface peripheral artery plaque morphology, while simultaneously pressing the drug-coating of the drug-coated flexible membrane onto and / or into the surface of the lesion 12. In some implementations, the compression member 150 smooths out irregularities on the inner surface of the vessel wall. In some implementations, after the initial fracture of the calcified tissue, the compression member 150 can be deployed in the rolling mode to increase the contact pressure while smoothly rolling along the inner vessel wall. The rolling mode can significantly enhance the contact pressure and efficiency of drug transfer, and reduce distal embolization of a quantity of drug that would otherwise not be effectively transferred to the lesion 12. In some implementations, the compression member 150 moves around like a roller spreading ink when the expandable member 140 is operating in the rolling mode. In some implementations, the controller 200 includes a mode manager maintained in memory 208 that selectively operates the motor 130 in the rolling mode. In some implementations, the rolling mode includes operating the motor to maintain a steady speed. In some implementations, the mode manager is configured to selectively operate the motor 130 to rotate the compression member 150 at a high angular velocity to develop centrical forces that contribute to the rolling pressure exerted by the compression member 150 onto the flexible membrane wall 122.

[0100] In some implementations, the process 300 includes or concludes by deflating the flexible membrane and retracting the catheter 100 from the diseased artery. In some implementations, the process 300 includes emplacing a stent within the vessel’s lumen proximate to the lesion 12. For example, implanting metal scaffolds (i.e., stents) to prop the vessel open and prevent elastic recoil.

[0101] In some implementations, a method includes: inserting a balloon portion within a vessel having a flow orifice constricted by debris; and / or partially expanding the balloon; and / or operating a motor to rotate an expandable member to break up calcifications and hard deposits within the vessel; and / or fully inflating the balloon and operating the motor to smooth the surface of the debris and improve the contact area (interface) between a balloon wall of the balloon portionand a surface of the debris; and / or deflating and subsequently retracting the balloon portion from the vessel.

[0102] In some implementations, the catheter 100 is provided as a kit including multiple interchangeable flexible membrane portions 120. For example, the kit may include: a set of flexible membrane portions (e.g., balloons) having various diameters, respectively; a set of balloons having various lengths, respectively; a set of balloons having drug coatings of varying compositions, respectively; and / or a set of balloons having various textured portions 170, respectively. In some implementations, the catheter 100 is provided as a kit including multiple interchangeable compression members 150. For example, the kit may include a set of compression members 150 including a bumpy roller, a smooth roller, a narrow roller, a wide roller, and a ridged roller.Test Data:

[0103] Referring to FIGS. 14-15, an amputated leg model was employed, complemented with advanced SEM technology to investigate the impact of plaque morphology on drug transfer in below-the-knee arteries. Nodular and smooth vessels were collected from two amputated limbs of CLTI patients, imaged with MRI, and fixed in formalin. The ex-vivo samples were then treated with appropriately sized Paclitaxel-coated balloons. The treated sections were sectioned into 5 mm samples and cut in half longitudinally. After air-drying, samples underwent gold coating and high-vacuum SEM. Two preselected samples (one “nodular” and one “smooth” surface) were scanned at 500x magnification, systematically covering the whole vessel surface for both samples with 300x300 micron field of views (FOV). Drug coverage area was quantified per FOV using ImageJ software and classified into percentage categories by two reviewers by consensus (minimal=0-25%, moderate=26-50%, good=51-75%, excellent=76-100%). Mann-Whitney U test compared drug amounts, and a Chi-square test assessed drug distribution homogeneity. SEM analysis provided 104 and 107 FOVs for the “nodular” and “smooth” samples, respectively.

[0104] Advantageously and unexpectedly, the study revealed significant differences in drug coverage between two groups: nodular lesions versus smooth lesions. This difference is statistically significant, as indicated by a chi-square value of 44.22 and a p-value of less than .001. Specifically, the overall drug coverage was substantially lower on the nodular samples compared to the smooth samples. The median drug coverage on nodular samples was categorized as “minimal to moderate”, whereas the smooth samples typically showed “good” drug coverage. Toelaborate, in the nodular sample group, 50% of the FOVs had “minimal” drug coverage. In contrast, 11% of the FOVs in the smooth sample group fell into this “minimal” coverage category. This discrepancy in coverage is statistically significant (p < .001). Furthermore, “excellent” drug coverage, was found in 38% of the FOVs in the smooth group, compared to 11% of the nodular group's FOVs, again with a statistically significant difference (p < .001).

[0105] As utilized herein with respect to numerical ranges, the terms “approximately,” “about,” “substantially,” and similar terms generally mean + / - 10% of the disclosed values. When the terms “approximately,” “about,” “substantially,” and similar terms are applied to a structural feature (e.g., to describe its shape, size, orientation, direction, etc.), these terms are meant to cover minor variations in structure that may result from, for example, the manufacturing or assembly process and are intended to have a broad meaning in harmony with the common and accepted usage by those of ordinary skill in the art to which the subject matter of this disclosure pertains. Accordingly, these terms should be interpreted as indicating that insubstantial or inconsequential modifications or alterations of the subject matter described and claimed are considered to be within the scope of the disclosure as recited in the appended claims.

[0106] It should be noted that the term “exemplary” and variations thereof, as utilized herein to describe various embodiments, are intended to indicate that such embodiments are possible examples, representations, or illustrations of possible embodiments (and such terms are not intended to connote that such embodiments are necessarily extraordinary or superlative examples).

[0107] The term “coupled” and variations thereof, as used herein, means the joining of two members directly or indirectly to one another. Such joining may be stationary (e.g., permanent or fixed) or moveable (e.g., removable or releasable). Such joining may be achieved with the two members coupled directly to each other, with the two members coupled to each other using a separate intervening member and any additional intermediate members. If “coupled” or variations thereof are modified by an additional term (e.g., directly coupled), the generic definition of “coupled” provided above is modified by the plain language meaning of the additional term (e.g., “directly coupled” means the joining of two members without any separate intervening member), resulting in a narrower definition than the generic definition of “coupled” provided above. Such coupling may be mechanical, electrical, or fluidic.

[0108] References herein to the positions of elements (e.g., “top,” “bottom,” “above,” “below”) are merely used to describe the orientation of various elements in the FIGURES. It should benoted that the orientation of various elements may differ according to other exemplary embodiments, and that such variations are intended to be encompassed by the present disclosure.

[0109] The hardware and data processing components used to implement the various processes, operations, illustrative logics, logical blocks, modules and circuits described in connection with the embodiments disclosed herein may be implemented or performed with a general purpose single- or multi-chip processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general purpose processor may be a microprocessor, or, any conventional processor, controller, or microcontroller. A processor may also be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. In some embodiments, particular processes and methods may be performed by circuitry that is specific to a given function. The memory (e.g., memory, memory unit, storage device) may include one or more devices (e.g., RAM, ROM, Flash memory, hard disk storage) for storing data and / or computer code for completing or facilitating the various processes, layers, and modules described in the present disclosure. The memory may be or include volatile memory or non-volatile memory, and may include database components, object code components, script components, or any other type of information structure for supporting the various activities and information structures described in the present disclosure. According to an exemplary embodiment, the memory is communicably connected to the processor via a processing circuit and includes computer code for executing (e.g., by the processing circuit or the processor) the one or more processes described herein.

[0110] The present disclosure contemplates methods, system and program products on any machine-readable media for accomplishing various operations. The implementations of the present disclosure may be implemented using existing computer processors, or by a special purpose computer processor for an appropriate system, incorporated for this or any other purpose, or by a hardwired system. Implementations within the scope of the present disclosure include program products comprising machine-readable media for carrying or having machine-executable instructions or data structures stored thereon. Such machine-readable media can be any available media that can be accessed by a general purpose or special purpose computer or other machine with a processor. By way of example, such machine-readable media can comprise RAM, ROM,EPROM, EEPROM, or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to carry or store desired program code in the form of machine-executable instructions or data structures and which can be accessed by a general purpose or special purpose computer or other machine with a processor. Combinations of the above are also included within the scope of machine-readable media. Machine-executable instructions include, for example, instructions and data that cause a general-purpose computer, special purpose computer, or special purpose processing machine to perform a certain function or group of functions.

[0111] Although the figures and description may illustrate a specific order of method steps, the order of such steps may differ from what is depicted and described, unless specified differently above. Also, two or more steps may be performed concurrently or with partial concurrence, unless specified differently above. Such variation may depend, for example, on the software and hardware systems chosen and on designer choice. All such variations are within the scope of the disclosure. Likewise, software implementations of the described methods could be accomplished with standard programming techniques with rule-based logic and other logic to accomplish the various connection steps, processing steps, comparison steps, and decision steps.

[0112] It is important to note that the construction and arrangement of the catheter 100 as shown in the various exemplary implementations is illustrative only. Additionally, any element disclosed in one implementation may be incorporated or utilized with any other implementation disclosed herein. Although only some examples of an element from one implementation that can be incorporated or utilized in another implementation have been described above, it should be appreciated that other elements of the various implementations may be incorporated or utilized with any of the other implementations disclosed herein.EXEMPLARY ASPECTSIn view of the described processes and compositions, hereinbelow are described certain more particularly described aspects of the disclosures. These particularly recited aspects should not, however, be interpreted to have any limiting effect on any different claims containing different or more general teachings described herein, or that the “particular” aspects are somehow limited in some way other than the inherent meanings of the language and formulas literally used therein.Example 1. A catheter, comprising; a first elongate member spanning between a first end and a second end and defining a first lumen therethrough; a second elongate member within the first lumen and spanning between a third end and a fourth end, and defining a second lumen therethrough; a flexible membrane portion provided at the first end of the first elongate member and in fluid communication with the first lumen, the flexible membrane portion comprising a flexible membrane wall enclosing a flexible membrane volume and configured to selectively transition between a deflated position and an inflated position; an expandable member comprising: a third elongate member within the flexible membrane volume and spanning between a fifth end and a sixth end, the third elongate member configured to rotate around a first axis or translate along a first axis within the flexible membrane volume; and a compression member coupled to the third elongate member and configured to rotate around a second axis offset from the first axis, wherein the second axis rotates around the first axis when the third elongate member rotates around the first axis, the compression member biased toward an extended position (e.g., smoothing position) wherein the second axis is spaced from the first axis by a first distance; wherein, when the flexible membrane portion is in the deflated position the compression member is in a retracted position wherein the second axis is spaced from the first axis by a second distance that is less than the first distance.Example 2. The catheter according to any example herein, particularly example 1, wherein when the flexible membrane portion is in an inflated position and a motor rotates the third elongate member around the first axis, the compression member is biased into contact with the flexible membrane wall and rotates around the second axis in a first rotational direction, and rotates around the first axis in a second rotational direction opposite the first rotational direction.Example 3. The catheter according to any example herein, further comprising a motor fixedly coupled to the second elongate member and operably coupled to the expandable member; wherein the fifth end of the third elongate member is coupled to the motor.Example 4. The catheter according to any example herein, further comprising a bushing or bearing portion provided at a distal end of the flexible membrane portion; and wherein the sixth end is received by the bushing or bearing portion.Example 5. The catheter according to any example herein, wherein the flexible membrane wall is coated in a drug.Example 6. The catheter according to any example herein, further comprising an electrical conduit within the second lumen and operably coupled to the motor.Example 7. The catheter according to any example herein, particularly example 6, further comprising a thrust bearing coupled to the third elongate member between the fifth end and an output shaft of the motor.Example 8. The catheter according to any example herein, wherein the third elongate member comprises an axial portion extending along the first axis and an eccentric portion that supports the compression member.Example 9. The catheter according to any example herein, further comprising a handle coupled to the second end of the first elongate member and the fourth end of the second elongate member.Example 10. The catheter according to any example herein, wherein the first elongate member and the second elongate member are made of a flexible material.Example 11. The catheter according to any example herein, further comprising a collar coupled between the first elongate member and the second elongate member at the first end of the first elongate member, the collar comprising a plurality of fluid channels that permit passage of fluids therethrough, and wherein the collar supports the third end of the second elongate member within the first lumen and substantially aligns the first axis and a longitudinal axis of the first elongate member.Example 12. The catheter according to any example herein, further comprising a seal provided at the third end of the second elongate member that fluidly separates an internal volume of the second lumen from the flexible membrane volume.Example 13. The catheter according to any example herein, wherein the flexible membrane portion is a balloon; wherein the expandable member is a balloon implement; wherein the third elongate member is a resilient wire; wherein the compression member is a compression member; wherein the first axis is a first axis; wherein the second axis is a roller axis; wherein the flexible membrane volume is a balloon volume; and wherein the flexible membrane wall is a balloon wall; wherein the second axis is eccentrically located relative to the first axis.Example 14. A method, comprising: inserting a catheter with a flexible membrane portion within a vessel having a flow orifice constricted by debris; partially expanding the flexible membraneportion; operating a motor to rotate an expandable member to break up calcifications and hard deposits within the vessel; fully inflating the flexible membrane portion; operating the motor to rotate the expandable member to smooth a surface of the debris and improve a contact area between a flexible membrane wall of the flexible membrane portion and a surface of the debris; and deflating and subsequently retracting the flexible membrane portion from the vessel.Example 15. The method according to any example herein, particularly example 14, wherein the catheter comprises: a first elongate member spanning between a first end and a second end and defining a first lumen therethrough; and a second elongate member within the first lumen and spanning between a third end and a fourth end, and defining a second lumen therethrough; and wherein the flexible membrane portion is provided at the first end of the first elongate member and is in fluid communication with the first lumen, the flexible membrane portion comprising a flexible membrane wall enclosing a flexible membrane volume and configured to selectively transition between a deflated position and an inflated position; and wherein the expandable member comprises: a third elongate member within the flexible membrane volume and spanning between a fifth end and a sixth end, the third elongate member configured to rotate around a first axis or translate along a first axis within the flexible membrane volume; and a compression member coupled to the third elongate member and configured to rotate around a second axis offset from the first axis, wherein the second axis rotates around the first axis when the third elongate member rotates around the first axis, the compression member biased toward an extended position (e.g., smoothing position) wherein the second axis is spaced from the first axis by a first distance; and wherein, when the flexible membrane portion is in the deflated position the compression member is in a retracted position wherein the second axis is spaced from the first axis by a second distance that is less than the first distance.Example 16. The method according to any example herein, particularly example 15, wherein when the flexible membrane portion is in an inflated position and a motor rotates the third elongate member around the first axis, the compression member is biased into contact with the flexible membrane wall and rotates around the second axis in a first rotational direction, and rotates around the first axis in a second rotational direction opposite the first rotational direction.Example 17. The method according to any example herein, particularly examples 15-16, wherein the catheter further comprises a motor fixedly coupled to the second elongate member and operably coupled to the expandable member; wherein the fifth end of the third elongate member is coupled to the motor.Example 18. The method according to any example herein, particularly examples 15-17, wherein the catheter further comprises a bushing or bearing portion provided at a distal end of the flexible membrane portion; and wherein the sixth end is received by the bushing or bearing portion.Example 19. The method according to any example herein, particularly examples 15-18, wherein the flexible membrane wall is coated in a drug.Example 20. The method according to any example herein, particularly examples 15-19, wherein the catheter further comprises an electrical conduit within the second lumen and operably coupled to the motor.Example 21. The method according to any example herein, particularly examples 15-20, wherein the catheter further comprises a thrust bearing coupled to the third elongate member between the fifth end and an output shaft of the motor.Example 22. The method according to any example herein, particularly examples 15-21, wherein the third elongate member comprises an axial portion extending along the first axis and an eccentric portion that supports the compression member.Example 23. The method according to any example herein, particularly examples 15-22, further comprising a handle coupled to the second end of the first elongate member and the fourth end of the second elongate member.Example 24. The method according to any example herein, particularly examples 15-23, wherein the first elongate member and the second elongate member are made of a flexible material.Example 25. The method according to any example herein, particularly examples 15-24, wherein the catheter further comprises a collar coupled between the first elongate member and the second elongate member at the first end of the first elongate member, the collar comprising a plurality of fluid channels that permit passage of fluids therethrough, and wherein the collar supports the third end of the second elongate member within the first lumen and substantially aligns the first axis and a longitudinal axis of the first elongate member.Example 26. The method according to any example herein, particularly examples 15-25, wherein the catheter further comprises a seal provided at the third end of the second elongate member that fluidly separates an internal volume of the second lumen from the flexible membrane volume.- T1 -Example 27. The method according to any example herein, particularly examples 15-26, wherein the flexible membrane portion is a balloon; wherein the expandable member is a balloon implement; wherein the third elongate member is a resilient wire; wherein the compression member is a compression member; wherein the first axis is a first axis; wherein the second axis is a roller axis; wherein the flexible membrane volume is a balloon volume; and wherein the flexible membrane wall is a balloon wall; and wherein the second axis is eccentrically located relative to the first axis.

Claims

WHAT IS CLAIMED IS:

1. A catheter, comprising; a first elongate member spanning between a first end and a second end and defining a first lumen therethrough; a second elongate member within the first lumen and spanning between a third end and a fourth end, and defining a second lumen therethrough; a flexible membrane portion provided at the first end of the first elongate member and in fluid communication with the first lumen, the flexible membrane portion comprising a flexible membrane wall enclosing a flexible membrane volume and configured to selectively transition between a deflated position and an inflated position; an expandable member comprising: a third elongate member within the flexible membrane volume and spanning between a fifth end and a sixth end, the third elongate member configured to rotate around a first axis or translate along a first axis within the flexible membrane volume; and a compression member coupled to the third elongate member and configured to rotate around a second axis offset from the first axis, wherein the second axis rotates around the first axis when the third elongate member rotates around the first axis, the compression member biased toward an extended position (e.g., smoothing position) wherein the second axis is spaced from the first axis by a first distance; wherein, when the flexible membrane portion is in the deflated position the compression member is in a retracted position wherein the second axis is spaced from the first axis by a second distance that is less than the first distance.

2. The catheter of claim 1, wherein when the flexible membrane portion is in an inflated position and a motor rotates the third elongate member around the first axis, the compression member is biased into contact with the flexible membrane wall and rotates around the second axis in a first rotational direction, and rotates around the first axis in a second rotational direction opposite the first rotational direction.

3. The catheter of any one of the preceding claims, further comprising a motor fixedly coupled to the second elongate member and operably coupled to the expandable member; wherein the fifth end of the third elongate member is coupled to the motor.

4. The catheter of any one of the preceding claims, further comprising a bushing or bearing portion provided at a distal end of the flexible membrane portion; and wherein the sixth end is received by the bushing or bearing portion.

5. The catheter of any one of the preceding claims, wherein the flexible membrane wall is coated in a drug.

6. The catheter of any one of the preceding claims, further comprising an electrical conduit within the second lumen and operably coupled to the motor.

7. The catheter of claim 6, further comprising a thrust bearing coupled to the third elongate member between the fifth end and an output shaft of the motor.

8. The catheter of any one of the preceding claims, wherein the third elongate member comprises an axial portion extending along the first axis and an eccentric portion that supports the compression member.

9. The catheter of any one of the preceding claims, further comprising a handle coupled to the second end of the first elongate member and the fourth end of the second elongate member.

10. The catheter of any one of the preceding claims, wherein the first elongate member and the second elongate member are made of a flexible material.

11. The catheter of any one of the preceding claims, further comprising a collar coupled between the first elongate member and the second elongate member at the first end of the first elongate member, the collar comprising a plurality of fluid channels that permit passage of fluids therethrough, and wherein the collar supports the third end of the second elongate member within the first lumen and substantially aligns the first axis and a longitudinal axis of the first elongate member.

12. The catheter of any one of the preceding claims, further comprising a seal provided at the third end of the second elongate member that fluidly separates an internal volume of the second lumen from the flexible membrane volume.1 . The catheter of any one of the preceding claims, wherein the flexible membrane portion is a balloon; wherein the expandable member is a balloon implement; wherein the third elongate member is a resilient wire; wherein the compression member is a rolling compression member;wherein the first axis is coupled to the output shaft of the motor; wherein the second axis is a roller axis; wherein the flexible membrane volume is a balloon volume; and wherein the flexible membrane wall is a balloon wall; wherein the second axis is eccentrically located relative to the first axis.

14. A method, comprising: inserting a catheter with a flexible membrane portion within a vessel having a flow orifice constricted by debris; partially expanding the flexible membrane portion; operating a motor to rotate an expandable member to break up calcifications and hard deposits within the vessel; fully inflating the flexible membrane portion; operating the motor to rotate the expandable member to smooth a surface of the debris and improve a contact area between a flexible membrane wall of the flexible membrane portion and a surface of the debris; and deflating and subsequently retracting the flexible membrane portion from the vessel.

15. The method of claim 14, wherein the catheter comprises: a first elongate member spanning between a first end and a second end and defining a first lumen therethrough; and a second elongate member within the first lumen and spanning between a third end and a fourth end, and defining a second lumen therethrough; and wherein the flexible membrane portion is provided at the first end of the first elongate member and is in fluid communication with the first lumen, the flexible membrane portion comprising a flexible membrane wall enclosing a flexible membrane volume and configured to selectively transition between a deflated position and an inflated position; and wherein the expandable member comprises: a third elongate member within the flexible membrane volume and spanning between a fifth end and a sixth end, the third elongate member configured to rotate around a first axis or translate along a first axis within the flexible membrane volume; and a compression member coupled to the third elongate member and configured to rotate around a second axis offset from the first axis, wherein the second axis rotates around the first axis when the third elongate member rotates around the first axis, the compression memberbiased toward an extended position (e.g., smoothing position) wherein the second axis is spaced from the first axis by a first distance; and wherein, when the flexible membrane portion is in the deflated position the compression member is in a retracted position wherein the second axis is spaced from the first axis by a second distance that is less than the first distance.

16. The method of claim 15, wherein when the flexible membrane portion is in an inflated position and a motor rotates the third elongate member around the first axis, the compression member is biased into contact with the flexible membrane wall and rotates around the second axis in a first rotational direction, and rotates around the first axis in a second rotational direction opposite the first rotational direction.

17. The method of any one of claims 15-16, wherein the catheter further comprises a motor fixedly coupled to the second elongate member and operably coupled to the expandable member; wherein the fifth end of the third elongate member is coupled to the motor.

18. The method of any one of claims 15-17, wherein the catheter further comprises a bushing or bearing portion provided at a distal end of the flexible membrane portion; and wherein the sixth end is received by the bushing or bearing portion.

19. The method of any one of claims 15-18, wherein the flexible membrane wall is coated in a drug.

20. The method of any one of claims 15-19, wherein the catheter further comprises an electrical conduit within the second lumen and operably coupled to the motor.

21. The method of any one of claims 15-20, wherein the catheter further comprises a thrust bearing coupled to the third elongate member between the fifth end and an output shaft of the motor.

22. The method of any one of claims 15-21, wherein the third elongate member comprises an axial portion extending along the first axis and an eccentric portion that supports the compression member.

23. The method of any one of claims 15-22, further comprising a handle coupled to the second end of the first elongate member and the fourth end of the second elongate member.

24. The method of any one of claims 15-23, wherein the first elongate member and the second elongate member are made of a flexible material.

25. The method of any one of claims 15-24, wherein the catheter further comprises a collar coupled between the first elongate member and the second elongate member at the first end of the first elongate member, the collar comprising a plurality of fluid channels that permit passageof fluids therethrough, and wherein the collar supports the third end of the second elongate member within the first lumen and substantially aligns the first axis and a longitudinal axis of the first elongate member.

26. The method of any one of claims 15-25, wherein the catheter further comprises a seal provided at the third end of the second elongate member that fluidly separates an internal volume of the second lumen from the flexible membrane volume.

27. The method of any one of claims 15-26, wherein the flexible membrane portion is a balloon; wherein the expandable member is a balloon implement; wherein the third elongate member is a resilient wire; wherein the compression member is a rolling compression member; wherein the first axis is coupled to the output shaft of the motor; wherein the second axis is a roller axis; wherein the flexible membrane volume is a balloon volume; and wherein the flexible membrane wall is a balloon wall; and wherein the second axis is eccentrically located relative to the first axis.

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