Vibrating wire guide for de-coring and suction of vein obstructions

Abstract

This disclosure generally relates to medical devices and the use of medical devices for treating vascular diseases. In particular, this disclosure provides apparatus and methods for cutting and / or core-removing vein obstructions (such as chronic clots) using a vibrating wire guide device.

Description

[0001] Cross-reference to related applications

[0002] none. Technical Field

[0003] This disclosure generally relates to medical devices and the use of medical devices for treating vascular diseases. In particular, this disclosure provides apparatus and methods for using a vibrating wire guide device to cut and / or coring through venous obstructions (such as chronic clots). Background Technology

[0004] Peripheral vascular disease refers to diseased blood vessels in a subject's vascular system that are far from the subject's heart and brain. Although peripheral vascular disease can occur in either the subject's arteries (arterial system) or veins (venous system), it typically occurs in the subject's venous system and often in the legs.

[0005] Veins carry blood back from all the body's organs to the heart. To reach the heart, blood needs to flow upwards through the veins in the legs. With each step, the muscles in the calves and feet contract to squeeze the veins and push the blood upwards. To keep blood flowing upwards and not downwards, veins contain one-way valves.

[0006] When these valves are damaged, venous insufficiency occurs, causing blood to leak back into the veins. Valve damage can be caused by aging, prolonged sitting or standing, or a combination of aging and reduced activity. When veins and valves weaken to the point where blood has difficulty flowing upwards to the heart, blood pressure in the veins remains high for extended periods, leading to blood clots.

[0007] A thrombosis is the formation of a blood clot within a blood vessel, called a thrombus. It obstructs the normal flow of blood through the circulatory system. When a blood clot forms in a vein, it is called venous thromboembolism. This can lead to deep vein thrombosis (DVT).

[0008] There are three main classifications of deep vein thrombosis (DVT), based on how long the blood clot has been present. When a blood clot forms and has been present for 14 days or less, it is called acute DVT. Within this short period, the blood clot in a DVT does not become very hard or adhere tightly to the vein wall, making acute DVT relatively easier to treat than other types of DVT. For example, acute DVT detected early enough can be treated with medications that dissolve the clot.

[0009] The second classification of DVT is called subacute DVT, which occurs when a blood clot has been present for 14 to 28 days. In the subacute phase, the blood clot may be slightly harder than during the acute phase, but not as hard as in the chronic phase.

[0010] The third major classification is chronic DVT, which occurs when a blood clot persists for 28 days or longer. In this case, the blood clot in the subject's arm or leg has the opportunity to harden and connect with the vein wall, which will later become scar tissue within the vein.

[0011] When a blood clot persists for longer than approximately 28 days, its composition changes from primarily fibrin (which can be dissolved by natural solubility) to cross-linked collagen. As the thrombus matures, it undergoes remodeling in a process similar to wound healing. White blood cells and other inflammatory cells infiltrate the thrombus; cellular components are replaced by collagen deposits, forming a new vascular network. These processes alter the composition and properties of the thrombus, thereby stimulating its resistance to thrombolytic therapy. The hardening of chronic thrombi is largely due to the cross-linking of fibrin and the replacement of cellular material with collagen. For example, after one week, the collagen content of the thrombus can reach approximately 20%, and after three weeks it can be as high as 80%.

[0012] Cross-linked collagen possesses rubbery, elastic, and resilient properties, and chronic clots can adhere firmly to the vein wall via tendrils known as adhesions. Once formed, chronic clots can drastically reduce venous blood flow, causing significant negative symptoms. Conventional interventional techniques, such as angioplasty, dissection, and stenting, are ineffective in treating cross-linked collagen in chronic clots because it is difficult to remove the clot without damaging the attached vein wall. Furthermore, conventional interventional techniques for treating chronic clots often require using a guidewire to penetrate the clot in order to introduce the interventional device. However, due to the hardening of chronic clots, known guidewires cannot penetrate and traverse the clot. Summary of the Invention

[0013] Certain rotatable cutting devices exist that can be used to cut through and / or core certain vascular lesions. However, using rotatable cutting devices to cut through and / or core chronic clots may not be desirable. What is needed is a non-rotatable cutting and / or core-removing device to penetrate and pass through the clot in order to introduce a guidewire. This disclosure discusses a non-rotatable wire guide device that penetrates chronic clots by ultrasonic vibration. These and other needs are addressed through various aspects, embodiments, and configurations of this disclosure. For example, this disclosure discusses a wire guide device with a specially designed non-rotatable head for cutting through and core-removing chronic clots, thereby creating a channel for insertion of the wire guide device therethrough.

[0014] Examples of the methods disclosed herein for forming a lumen through an obstruction in a subject's venous system include: determining the location of the obstruction in the subject's venous system; positioning a balloon catheter within the subject's venous system and adjacent to the obstruction, wherein the balloon catheter includes an inflatable member that expands within the venous system; positioning an aspiration catheter within the subject's blood vessel, wherein the aspiration catheter extends beyond the distal end of the balloon catheter; and positioning a non-rotatable wire guide within the subject's venous system, wherein the non-rotatable wire guide includes a cutting head, and the cutting head is... The chronic clot is adjacent, wherein the cutting head includes a proximal end and a distal end, the proximal end including a concave shape and the distal end including a convex shape, the concave shape including a proximal end and a distal end, the proximal end of the cutting head including a diameter, wherein the ratio of the length between the distal end of the cutting head and the proximal end of the concave shape to the diameter of the cutting head is between 1.5:1 and 3:1; fluid is introduced into a balloon catheter or aspiration catheter; and ultrasonic energy is applied to a non-rotatable filament guide device such that the cutting head of the non-rotatable filament guide device is axially translated back and forth without rotation, and fluid is aspirated during the translation of the cutting head.

[0015] Another example includes the method described in the preceding paragraph, which also includes the step of repositioning the cutting head.

[0016] Another example includes the method described in any of the preceding paragraphs, and also includes the step of aspirating fluid.

[0017] Another example includes the method described in any of the preceding paragraphs, wherein the cutting head includes a plurality of blades spaced evenly around the periphery of the cutting head.

[0018] Another example includes the method described in any of the preceding paragraphs, wherein the blade is substantially parallel to and aligned with the longitudinal axis of the shaft.

[0019] Another example includes the method described in any of the preceding paragraphs, wherein the blade has a proximal end, a distal end, a height, and a width.

[0020] Another example includes the method described in any of the preceding paragraphs, wherein the height of at least one of the plurality of blades increases from the distal end of the at least one of the plurality of blades to its proximal end.

[0021] Another example includes the method described in any of the preceding paragraphs, wherein the width of at least one of the plurality of blades increases from the distal end of the at least one of the plurality of blades to its proximal end.

[0022] Examples of catheter systems disclosed herein include: a balloon catheter including an inflatable member; an aspiration catheter configured to extend beyond the distal end of the balloon catheter; and a non-rotatable filament guide including a cutting head comprising a proximal end and a distal end, the proximal end comprising a recessed shape, the distal end comprising a convex shape, the recessed shape comprising a proximal end and a distal end, the proximal end of the cutting head comprising a diameter, wherein the ratio of the length between the distal end of the cutting head and the proximal end of the recessed shape to the diameter of the cutting head is between 1.5:1 and 3:1, wherein the non-rotatable filament guide is configured to translate axially back and forth without rotation.

[0023] Another example includes the conduit system described in the preceding paragraph, wherein the cutting head includes a plurality of blades spaced evenly around the periphery of the cutting head.

[0024] Another example includes the conduit system described in the preceding paragraph, in which the blade is substantially parallel to and aligned with the longitudinal axis of the shaft.

[0025] Another example includes the catheter system described in the preceding paragraph, wherein the blade has a proximal end, a distal end, a height, and a width.

[0026] Another example includes the catheter system described above, wherein the height of at least one of the plurality of blades increases from the distal end of the at least one of the plurality of blades to its proximal end.

[0027] Another example includes the catheter system described above, wherein the width of at least one of the plurality of blades increases from the distal end of the at least one of the plurality of blades to its proximal end.

[0028] Another example includes the aforementioned conduit system, wherein the width of at least one of the plurality of blades increases from the distal end of the at least one of the plurality of blades to its proximal end.

[0029] 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 oWhen 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 ).

[0030] 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.

[0031] Unless otherwise specifically mentioned herein, the term “approximately” when used with a numerical value shall refer to the sum and / or negative ten percent (10%) of that value.

[0032] As used herein, the term "catheter" generally refers to a tube capable of being inserted into a body cavity, channel, lumen, or blood vessel (e.g., the vascular system). In most applications, a catheter is a relatively thin, flexible tube ("soft" catheter), but in some applications it may also be a larger, solid, less flexible (but still flexible) catheter ("rigid" catheter). In some applications, a catheter may contain a lumen along part or all of its length to allow for the introduction of other catheters or guidewires. An example of a catheter is a sheath.

[0033] As used herein, the term "balloon catheter" generally refers to various types of catheters that carry a balloon for containing fluid. Balloon catheters can also have a wide variety of internal structures (e.g., different lumen designs), among which at least three basic types exist: triple-lumen, double-lumen, and coaxial-lumen. It is intended in this document that the term "balloon catheter" encompasses all variations in internal structure and design. In some applications, balloon catheters can be used for angioplasty.

[0034] The term “means” as used herein shall be given the broadest possible interpretation in accordance with 35 U.S.SC §112(f). Therefore, claims containing the term “means” shall cover all structures, materials, or actions set forth herein and all their equivalents. Furthermore, structures, materials, or actions and their equivalents shall include all that is described in the summary, description of the drawings, detailed description, abstract, and claims.

[0035] As used herein, the term "sheath" generally refers to a tube that can be inserted into a body cavity, tube, lumen, or blood vessel (e.g., a vascular system), allowing the introduction of other devices (such as catheters) and the introduction of fluid along its length. Sheaths can have closed or open ends. Because a sheath is a tube that can be inserted into a body cavity, tube, lumen, or blood vessel (e.g., a vascular system), it can also be considered a catheter. Accordingly, catheters, such as laser catheters, can be introduced into another catheter.

[0036] As used herein, the term "therapeutic agent" generally refers to any known or subsequently discovered pharmacologically active agent that provides treatment to a subject by alleviating one or more of the subject's physiological symptoms. Therapeutic agents can be naturally occurring compounds, chemically modified naturally occurring compounds, or chemically synthesized compounds. Such agents are generally selected from recognized classes of pharmacologically active agents, including but not limited to: analgesics; anesthetics; anti-arthritis drugs; respiratory drugs (including anti-asthmatic drugs); anticancer drugs (including antitumor drugs); anticholinergics; anticonvulsants; antidepressants; antidiabetic drugs; antidiabetic drugs; antidiabetic drugs; anti-worm drugs; antihistamines; antilipidemic drugs; antihypertensive drugs; anti-infectives (e.g., antibiotics and antivirals); anti-inflammatory drugs; anti-migraine preparations; rectal medications; anti-Parkinson's disease drugs; antipruritics; antipsychotics; antipyretics; antispasmodics; antituberculosis drugs; antiulcer drugs; antiviral drugs; anxiolytics; appetite suppressants; and drugs for attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD). Drugs; cardiovascular preparations (including calcium channel blockers, CNS drugs); beta-blockers and antiarrhythmic drugs; central nervous system stimulants; cough and cold preparations (including decongestants); diuretics; genetic materials; herbal remedies; hormone blockers; hypnotics; hypoglycemic agents; immunosuppressants; leukotriene inhibitors; mitotic inhibitors; restenosis inhibitors; muscle relaxants; anesthetic antagonists; nicotine; nutritional supplements (e.g., vitamins, essential amino acids, and fatty acids); ophthalmic drops (e.g., antiglaucoma drops); parasympathetic drugs; psychostimulants; sedatives; steroids; sympathomimetic drugs; tranquilizers; and vasodilators (including those for the general coronary, peripheral, and cerebral arteries).

[0037] As used in this article, the terms "vascular system" and "vascular vessels" refer to any part of the subject's circulatory system (including peripheral and non-peripheral arteries and veins). The vascular system may be composed of materials such as nucleic acids, amino acids, carbohydrates, polysaccharides, lipid fibrous tissue, calcium deposits, dead cell remnants, and cell debris.

[0038] The term "vascular occlusion" or "occlusion" refers to the accumulation of fat, lipids, fibrin, fibrocalcified plaques, thrombi, and other atherosclerotic tissue within the lumen or intima of an artery. This accumulation narrows or completely obstructs the internal lumen of the artery, thereby restricting or blocking the normal flow of blood through the arterial segment. Occlusion can partially or completely block the vascular system. Therefore, the term "vascular occlusion" or "occlusion" should include both complete and partial occlusion. Alternatively, vascular occlusion or occlusion can also be referred to as vascular blockage (or obstruction) or vascular restriction (or limitation). Thus, vascular blockage can refer to complete or partial obstruction, while vascular restriction can refer to complete or partial restriction.

[0039] It should be understood that each maximum numerical limit given throughout this disclosure is considered to include, as alternative to, every and every lower numerical limit, as if such lower numerical limits were expressly stated herein. Each minimum numerical limit given throughout this disclosure is considered to include, as alternative to, every and every larger numerical limit, as if such larger numerical limits were expressly stated herein. Each numerical range given in this disclosure is considered to include, as if falling within that wider numerical range, every and every narrower numerical range, as if such narrower numerical ranges were all expressly stated herein.

[0040] The foregoing is a simplified summary of this disclosure, intended to provide an understanding of some aspects of the disclosure. This summary is neither extensive nor exhaustive; it is not intended to identify key or essential elements of the disclosure, nor to depict its scope, but rather to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description given below. As will be understood, other aspects, embodiments, and configurations of the disclosure may utilize one or more features described above or in detail below, individually or in combination. Attached Figure Description

[0041] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate several examples of this disclosure. These drawings, together with the description, explain the principles of this disclosure. The drawings simply illustrate preferred and alternative examples of how this disclosure can be made and used, and should not be construed as limiting this disclosure to the examples shown and described. Other features and advantages will become apparent from the following more detailed description of various aspects, embodiments, and configurations of this disclosure, as illustrated in the accompanying drawings with reference to them.

[0042] Figure 1 An exemplary system is shown, which includes an ultrasonic generator and a non-rotatable filament guide that transmits and emits ultrasonic energy.

[0043] Figure 2This is a side view of the kit, which includes a non-rotatable wire guide, an aspiration catheter assembly, and a balloon catheter assembly.

[0044] Figure 3 yes Figure 2 Side view of the balloon catheter assembly.

[0045] Figure 4 yes Figure 2 Side view of the suction catheter assembly.

[0046] Figure 5 yes Figure 2 An enlarged side view of the distal portion of the kit 190 within line 5-5, wherein a portion of the aspiration catheter assembly extends beyond the distal end of the balloon catheter assembly, and a portion of the non-rotatable filament guide extends beyond the aspiration catheter assembly.

[0047] Figure 6 yes Figure 1 and Figure 5 An enlarged side view of the cutting head of the non-rotatable wire guide device shown.

[0048] Figure 6A yes Figure 6 A perspective view of the cutting head of the non-rotatable wire guide device shown.

[0049] Figure 7A yes Figure 1 and Figure 5 An enlarged side view of the alternative cutting head for the non-rotatable wire guide device shown.

[0050] Figure 7B It was cut along the BB line. Figure 7A A cross-sectional view of the alternative cutting head shown.

[0051] Figure 8A It is a longitudinal sectional view of a vein taken along a direction parallel to the vein's longitudinal axis, showing the presence of chronic clots within the vein.

[0052] Figure 8B This is a longitudinal cross-sectional view of a balloon catheter with a chronic clot in an adjacent vein.

[0053] Figure 8C This is a longitudinal cross-sectional view of an aspiration catheter extending distal to a balloon catheter carrying a chronic clot in an adjacent vein.

[0054] Figure 8D It is a longitudinal cross-sectional view of the cutting head extending distally to the aspiration catheter and balloon catheter, wherein the cutting head is adjacent to and proximal to a chronic clot in the vein.

[0055] Figure 8EIt is a longitudinal cross-sectional view of the cutting tip extending distally to the aspiration catheter and balloon catheter, wherein the cutting tip extends into the chronic clot in the vein and passes through the chronic clot to form a lumen.

[0056] Figure 8F It is a longitudinal cross-sectional view of the cutting tip extending distally to the aspiration catheter and balloon catheter, wherein the cutting tip extends completely through the chronic clot in the vein after forming a lumen by core removal through the chronic clot.

[0057] Figure 9 Is using Figure 2 The diagram shows a representative flowchart of the method for treating subjects with the kit.

[0058] Figure 10 This is an enlarged cross-sectional view of a vein with chronic blood clots, the chronic blood clots being composed of… Figure 5 , 6 The non-rotatable filament guides shown in 7A and 7 use Figure 9 The method shown in the figure produces a through-hole lumen. Detailed Implementation

[0059] This disclosure generally relates to the use of medical devices for treating vascular diseases. In particular, this disclosure provides materials and methods for using laser-induced pressure waves to disrupt vascular obstructions and deliver therapeutic agents to the obstructed area.

[0060] refer to Figure 1 The illustration depicts an exemplary ultrasound system 100 of this disclosure. The ultrasound system 100 includes an ultrasound generator 120 coupled to a controller 125. The controller 125 includes one or more computing devices programmed to control the ultrasound generator 120. The controller 125 may be internal to or external to the ultrasound generator 120. In some embodiments, the ultrasound generator 120 generates ultrasound energy in the form of fixed or modulated pulses at a given frequency or a variety of frequencies having a predetermined range.

[0061] The ultrasound generator 120 is connected to the proximal end of the non-rotatable wire guide 110 via a connector 115. The distal end of the non-rotatable wire guide 110 can be inserted into the vascular system or tissue of the human subject 105. For example, the distal end of the non-rotatable wire guide 110 can be inserted into the subject's venous system via one or more types of catheters as discussed herein.

[0062] Figure 1The controller 125 includes a non-transitory computer-readable medium (e.g., memory (not shown)) containing instructions that, when executed, cause one or more processors (not shown) to control the ultrasound generator 120 and / or other components of the ultrasound system 100. The controller 125 includes one or more input devices to receive input from an operator. Exemplary input devices include buttons, keypads, touchscreens, dials, switches, mice, and trackballs, which provide user control of the ultrasound generator 120. The controller 125 also includes one or more output devices to provide feedback or information to the operator. Exemplary output devices include displays, lights, and audio devices that provide user feedback or information.

[0063] Figure 1 The illustration depicts a non-rotatable wire guide 110 entering a human subject, preferably through the femoral vein, iliac vein, great saphenous vein, or other veins in the subject's leg. As described above, this may be preferred for treating peripheral vascular diseases, such as thrombi or chronic clots that have formed in the subject's venous system. Furthermore, the ultrasound system 100 can be used to treat coronary artery disease (CAD) or other types of peripheral artery disease (PAD). If the ultrasound system 100 is used to treat CAD, the non-rotatable wire guide 110 can enter the femoral artery, and the non-rotatable wire guide 110 will traverse the patient's vascular system and be guided to the coronary artery. Alternatively, if the wire guide 110 is used to treat PAD, the non-rotatable wire guide 110 will traverse the patient's vascular system and be guided to peripheral arteries, such as those below the knee, particularly those in the patient's leg and / or foot.

[0064] refer to Figure 2 The illustration shows a kit 190, which includes a balloon catheter assembly 130, an aspiration catheter assembly 150, and a non-rotatable wire guide 110. The balloon catheter assembly 130 may also be referred to as an outer sheath assembly or outer catheter assembly 130 because of its position relative to the aspiration catheter assembly 150 and the non-rotatable wire guide 110.

[0065] Figure 3 draw Figure 2 The balloon catheter assembly 130 shown is... Figure 4 draw Figure 2The aspiration catheter assembly 150 is shown. The balloon catheter assembly 130 may include a proximal portion, a distal portion, and a catheter or sheath 132 having a working length of approximately 50 cm to 200 cm (inclusive), and a lumen extending between these ends. The proximal end of the balloon catheter assembly 130 may include a bifurcation 134 (or a Y-connector) that engages with the sheath 130 via a Luer connector 136. The bifurcation 134 may include a hemestasis valve comprising a tube 140 extending in one direction (e.g., an axial direction) and another tube 142 extending in a direction offset relative to the tube 140. The tube 140 may have an opening 138 through which the aspiration catheter assembly 150 can enter. The tube 140 may also include the hemestasis valve at or near the opening 138. The aspiration catheter assembly 150 extends through a lumen from the proximal end of the balloon catheter assembly 130 to the distal end of the balloon catheter assembly 130. The tube 142 may include a stopper through which a liquid medium can enter the balloon assembly 130. The liquid medium can be used to inflate the inflatable member or as a flushing fluid.

[0066] refer to Figure 4 , plotted Figure 2 The aspiration catheter assembly 150 is shown in the diagram. The aspiration catheter assembly 150 may include a proximal portion, a distal portion, and a catheter or sheath 152 having a working length of approximately 50 cm to 200 cm (inclusive), and a lumen extending between these ends. The proximal end of the aspiration catheter assembly 150 may include a bifurcator 154 (or a Y-connector) that engages with the sheath 152 via a Luer connector. The bifurcator 154 may include a tube 160 extending in one direction (e.g., an axial direction) and another tube 156 extending in a direction offset relative to the tube 160. The tube 160 may have an opening through which a non-rotatable filament guide 110 can enter. The tube 160 may also include a isomorphic valve at or near the opening. The non-rotatable filament guide 110 is capable of extending through the lumen therein from the proximal end to the distal end of the aspiration catheter assembly 150. Another tube 156 may include a plug 158 through which aspirated fluid exits the aspiration conduit assembly 150.

[0067] refer to Figure 5The figure illustrates the distal portion 500 of the assembly 190, particularly the distal portions of the shaft 165 of the balloon catheter assembly 130, the aspiration catheter assembly 150, and the non-rotatable wire guide 110, and the cutting head 200. As shown in the figure, the distal portion of the balloon catheter assembly 130 includes an inflatable member 144 (e.g., a balloon) surrounding the exterior of a sheath 132. The sheath 132 includes a lumen, while the distal portion of the aspiration catheter assembly 150, i.e., the sheath 152, extends from the sheath 132 of the balloon catheter assembly 130 through the lumen of the sheath 132. Arrows between the distal ends of the sheaths 132 and 152 indicate flushing fluid entering the vascular (e.g., venous) system between the distal ends of the sheaths 132 and 152.

[0068] Continue to refer to Figure 5 The diagram illustrates the distal portion of a non-rotatable filament guide 110, which includes a filament guide shaft 165 and a cutting or core-removing tip 200 attached to its distal end. A sheath 152 includes a lumen through which the distal portion of the non-rotatable filament guide 110 (including the cutting tip 200) extends from the sheath 152 of the aspiration catheter assembly 150 through the lumen of the sheath 152. An arrow between the distal end of the sheath 152 and the shaft 165 of the non-rotatable filament guide 110 indicates aspirated fluid exiting the vascular system (e.g., a venous system) between the distal end of the sheath 152 and the non-rotatable filament guide 110.

[0069] refer to Figure 6 and Figure 6A The diagram shows an enlarged view of the distal portion of a non-rotatable filament guide 110, including a filament guide shaft 165 and a cutting head 200. As shown in these figures, the cutting head 200 includes a concave proximal end 230 and a convex distal end 235. Regarding the concave proximal end 230, this portion of the cutting head 200 has a cup-shaped or bowl-shaped form because this end bends inward from the proximal end of the cutting head 200 toward the distal end of the cutting head 200, just as this end also bends inward from the circumferential cutting edge 270 toward the center of the cutting head 200, at which point the cutting head 200 is attached to the shaft 165.

[0070] The cutting head 200 also includes a plurality of blades 215, which are aligned and / or parallel to the longitudinal axis of the non-rotatable wire guide 110 (including the wire guide shaft 165 and the cutting head 200) between their proximal and distal ends. The plurality of blades 215 are also evenly spaced around the periphery of the cutting head 200 such that the blades 215 are substantially parallel to and aligned with the shaft 165 of the wire guide 110 and the longitudinal axis of the cutting head 200. Each blade 215 has a height (h) extending from the surface of the cutting head 200. At the top of the height of each blade 215, there is a sharp surface to cut through chronic clots or thrombi. The blades 215 also have a proximal end 225 and a distal end 220, thus the blades 215 have a length (D). The height (h) of each or some blades 215 from distal end 220 to proximal end 225 can be constant, or the height (h) of each or some blades 215 can increase or decrease as the blades advance from distal end 220 to proximal end 225. This blade height configuration can improve the ability and effectiveness of the blades 215 in cutting through chronic clots or thrombi. The proximal end 230 of the recessed portion of the cutting head 200 may have a cutting edge 270. The cutting edge 270 can aid in core removal of lesions or chronic clots by utilizing longitudinal movement or vibration of the wire guide 110 from ultrasonic frequencies transmitted via the system transducer to the wire guide 110. The cutting edge 270 is sharp and depicted as having a flat profile, but alternatively, the cutting edge 270 may have a serrated or rounded serrated proximal profile. Because the cutting edge 270 is formed at the intersection of the outer periphery of the cutting head 200 and its recessed portion, at least a portion of the cutting edge 270 faces the proximal side.

[0071] The width (w) of each or some blades 215 from the distal end 220 to the proximal end can be constant, or the width (w) of each or some blades 215 can increase as the blade advances from the distal end 220 to the proximal end 225, or the width (w) of each or some blades 215 can decrease as the blade advances from the distal end 220 to the proximal end. The width configuration of the blades 215 can improve the ability and effectiveness of the blades 215 to cut through chronic clots or thrombi.

[0072] As described above, the cutting head 200 includes a concave proximal end 230. When the non-rotatable filament guide 110 (including the filament guide shaft 165 and the cutting head 200) oscillates axially back and forth along the longitudinal axis of the non-rotatable filament guide 110, the concave shape of the proximal end of the cutting head 200 facilitates the suction of flushing fluid and clot fragments, thereby directing the flushing fluid into the suction lumen of the suction conduit 150. For example, the proximal end of the cutting head 200 has a diameter (A), and the radius of the concave shape can preferably be shallow or deep to form a cutting edge on the proximal end. Alternatively, refer to... Figure 6A The ends of the cutting surface or cutting edge 270 can be serrated or rounded to further aid in the cutting. Examples of the depth of the recessed proximal end (or radius) can be between 0.025 inches and 0.100 inches, such as 0.025 inches, 0.050 inches, 0.075 inches, or 0.100 inches.

[0073] The concave shape at the proximal end of the cutting head 200 has a radially inner portion (closest to the wire guide shaft 165 radially) and a radially outer portion (farthest from the wire guide shaft 165 radially), with the radially outer portion proximal to the inner portion. For example... Figure 6 As shown, the distance or length between the farthest portion of the distal end 235 of the convex shape and the interior of the proximal end 230 of the concave shape is defined as length (F). Furthermore, the distance or length between the farthest portion of the distal end 235 of the convex shape and the exterior of the proximal end 230 of the concave shape is defined as length (B). Preferably, the difference between F and B can be quite large, such that the edge 235 is defined and sharp to aid in cutting lesions or core removal of lesions.

[0074] Continue to refer to Figure 6 The distal end of the cutting head 200 has a convex shape with a diameter (E), wherein the diameter of the cutting head 200 is determined at the position of the distal end 220 where the blade 215 is provided. Preferably, the ratio of diameter E to diameter A is between about 1:4 and 1:1.5, for example about 1:4, 1:3.5, 1:3, 1:2.5, 1:2, and 1:1.5.

[0075] Preferably, the ratio of the length B of the cutting head 200 to the diameter A of the proximal end of the cutting head 200 is between about 1.5:1 and 3:1, for example, about 1.5:1.0, 1.75:1.0, 2.0:1.0, 2.25:1.0, 2.50:1.0, 2.75:1.0 or 3.0:1.0.

[0076] Continue to refer to Figure 6As described above, the blade 215 has a length (D) extending from the proximal end 225 to the distal end 220. Preferably, the length D of the blade 215 is a percentage of the length B of the cutting head 200, such as ten percent or up to the entire length B, in which case the blade 215 extends from the cutting edge 270 to the distal end 220. The blades 215 may converge at the distal end of 200 and may connect or meet at the distal end. Figure 6 As shown, the proximal end 225 of the blade 215 is disposed distal to the recessed proximal end of the cutting head 200, while the distal end 220 of the cutting head 200 is disposed proximal to the protruding distal end of the cutting head 200. However, the proximal end 225 of the blade 215 may begin at the recessed proximal end of the cutting head 200 and extend to the protruding distal end of the cutting head 200 or to a position proximal to the protruding distal end of the cutting head 200. Similarly, the distal end 220 of the blade 215 may begin at the protruding distal end of the cutting head 200 and extend to the recessed proximal end of the cutting head 200 or to a position distal to the recessed proximal end of the cutting head 200.

[0077] refer to Figure 7A and Figure 7B An alternative non-rotatable filament guide 110' is shown, comprising a filament guide shaft 165' and a cutting head 700, wherein the cutting head 700 has a concave proximal end 730 and a convex distal end 735. (Compared to...) Figure 5 , Figure 6 and Figure 6A Compared to the cutting head 200 shown (which has a plurality of blades 215 extending from the outside of the cutting head 200), the cutting head 700 includes a plurality of recesses 705 recessed into the outside of the cutting head 700. Each recess 705 has a distal end 710 and a proximal end 715, and the recesses 705 are evenly spaced around the outside or periphery of the cutting head 700 and are aligned and parallel to the non-rotatable wire guide 110' and the longitudinal axis of the cutting head 700. Since each recess 705 is recessed into the cutting head 700, each recess 705 has two sharp cutting edges 220 on each side of the recess 705.

[0078] Each groove 705 has a depth (d) extending from the surface of the cutting head 700 toward its center. The depth (d) of each or some grooves 705 from the distal end 710 to the proximal end 715 may be constant, or the depth (d) of each or some grooves 705 may increase as the groove advances from the distal end 710 to the proximal end 715, or the depth (d) of each or some grooves 705 may decrease as the groove advances from the distal end 710 to the proximal end 715. The height configuration of the grooves 705 can improve the ability and effectiveness of the grooves 705 in cutting through chronic clots or thrombi.

[0079] The width (w) of each or some grooves 705 from the distal end 710 to the proximal end 715 can be constant, or the width (w) of each or some grooves 705 can increase as the grooves advance from the distal end 710 to the proximal end 715, or the width (w) of each or some grooves 705 can decrease as the grooves advance from the distal end 710 to the proximal end 715. The width configuration of the grooves 705 can improve the ability and effectiveness of the grooves 705 to cut through chronic clots or thrombi.

[0080] Continue to refer to Figure 7A and Figure 7B References A, B, C, E, and F of the cutting head 700 are shown, which are related to... Figure 6 Reference items A, B, C, E, and F of the cutting head 200 shown are the same or similar. The cutting head 700 does not have a plurality of blades 215 extending from the outside of the cutting head 200, but instead includes a plurality of grooves 705 recessed into the outside of the cutting head 700. However, including and / or relating to... Figure 6 The ratios of reference items A, B, C, E, and F in the cutting head 200 are applicable to Figure 7A and 7B Reference items A, B, C, E, and F of the cutting head 700 are shown in the figure.

[0081] Continue to refer to Figure 7A and 7B The groove 705 has a length (D) extending from a proximal end 715 to a distal end 710. Preferably, the percentage of the length D of the groove 705 to the length B of the cutting head 700 is as small as ten percent of the length of 700 or the entire length of 700. The groove 705 may converge at the distal end 735, such that the groove connects or terminates at the distal end. Figure 7A and 7B As shown, the proximal end 715 of the groove 705 is disposed at the recessed proximal end of the cutting head 700, while the distal end 710 of the cutting head 700 is disposed proximal to the protruding distal end of the cutting head 700. However, the proximal end 715 of the groove 705 may begin distal to the recessed proximal end of the cutting head 700 and extend to the protruding distal end of the cutting head 700 or to a position proximal to the protruding distal end of the cutting head 700. Furthermore, the distal end 220 of the groove 705 may begin at the protruding distal end of the cutting head 200 and extend to the recessed proximal end of the cutting head 700 or to a position distal to the recessed proximal end of the cutting head 700.

[0082] refer to Figure 9 The illustration shows examples of the use of, for example, a non-rotatable wire guide device 110 and a balloon catheter assembly 130 (in... Figure 3 (as shown in the diagram) and aspiration catheter assembly 150 (in Figure 4 The kit 190 (as shown in the illustration) Figure 2The steps of method 900 (illustrated in the diagram) are to create a lumen in and through a thrombus, chronic clot, or vascular obstruction in the vascular system of a human subject (particularly the subject's venous system). For example, Figure 8A A chronic clot 805 is depicted within vein 810. Figure 9 Method 900 includes determining the location of a chronic clot 805 in a subject's vein at step 905. A next step 910 of method 900 includes positioning a balloon catheter 130 (e.g., a sheath 132) within the subject's vein 810 adjacent to the chronic clot 805, wherein the balloon catheter 130 includes an inflatable member 144. When the balloon catheter 130 (e.g., a sheath 132) is positioned adjacent to the chronic clot, the inflatable member 144 is inflated within the vein 810, as... Figure 8B As shown, contrast agents and saline are typically used to make the image visible under X-ray / fluorescence examination.

[0083] Refer again Figure 9 Method 900 further includes step 915 of positioning an aspiration catheter 150 within a vein 810 of the subject, wherein the aspiration catheter 150 (e.g., sheath 152) extends through the lumen of a balloon catheter 130 (e.g., sheath 132) and beyond the distal end of the balloon catheter 130 (e.g., sheath 132), and is adjacent to a chronic clot 805, as shown. Figure 8C As shown. The next step 920 of method 900 includes positioning a non-rotatable wire guide 110 within a vein 810 of the subject, wherein the non-rotatable wire guide 110 (including a wire guide shaft 165 and a cutting head 200) extends through the lumen of an aspiration catheter 150 (e.g., a sheath 152) and beyond the distal end of the aspiration catheter 150 (e.g., a sheath 132), and is adjacent to a chronic clot 805, as shown. Figure 8D As shown in the diagram. The next step 925 of method 900 includes introducing a flushing fluid (such as sterile saline) into the working channel of the aspiration catheter 150, such that the flushing fluid reaches the chronic clot 805, and simultaneously applying ultrasonic energy to the non-rotatable filament guide 110, causing the filament guide shaft 165 and the cutting head 200 of the non-rotatable filament guide 110 to translate axially back and forth without rotation, so that the filament guide shaft 165 and the cutting head 200 pass through the chronic clot, as shown. Figure 8E and 8FAs shown. When the wire guide 110 vibrates and / or rubs against the lesion, the flushing fluid in the aspiration catheter or flushing sheath also helps to cool the wire guide 110. As the cutting head 200 passes through the chronic clot 805, the aspiration catheter 150 (e.g., sheath 152) aspirates flushing fluid during the translation of the cutting head 200 through the chronic clot. The user of kit 190 may repeat any of steps 905 to 925 as needed, as shown in step 930. After completing steps 905 to 930, the non-rotatable wire guide, aspiration catheter, and balloon catheter are removed from the vascular system (after the inflatable member has contracted), as shown in step 935.

[0084] refer to Figure 10 After method 900 is completed, the thrombus, chronic clot, or vascular obstruction 805 passing through the subject's blood vessel 810 is cored or a lumen 815 is formed. As shown in the figure, the indentation 820 within the vascular obstruction corresponds to the shape of the blade 215 on the cutting head 200.

[0085] 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.

[0086] 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.

[0087] Furthermore, while the description of this disclosure has included descriptions of one or more aspects, embodiments, and configurations, as well as certain variations and modifications, other variations, combinations, and modifications are also within the scope of this disclosure, for example, upon understanding this disclosure and to the skill and knowledge of those skilled in the art. It is intended to obtain rights to alternative aspects, embodiments, and configurations included within the permissible scope, including alternative, interchangeable, and / or equivalent structures, functions, scopes, or steps to be claimed, whether such alternative, interchangeable, and / or equivalent structures, functions, scopes, or steps are disclosed herein, and it is not intended to publicly offer any patentable subject matter.

Claims

1. A catheter system, comprising: Balloon catheters including expandable components; Aspiration catheter, which is configured to extend beyond the distal end of the balloon catheter; as well as A non-rotatable filament guide includes a cutting head having a proximal end and a distal end, the proximal end having a concave shape and the distal end having a convex shape, the concave shape having a proximal end and a distal end, the proximal end of the cutting head having a diameter, wherein the ratio of the length between the distal end of the cutting head and the proximal end of the concave shape to the diameter of the cutting head is between 1.5:1 and 3:1, wherein the non-rotatable filament guide is configured to translate axially back and forth without rotation; The non-rotatable filament guide is configured to be connected to an ultrasonic generator to apply ultrasonic energy to the non-rotatable filament guide, causing the cutting head of the non-rotatable filament guide to translate axially back and forth without rotation.

2. The catheter system according to claim 1, wherein, The cutting head includes a plurality of blades evenly spaced around its periphery.

3. The catheter system according to claim 2, wherein, The blade is substantially parallel to and aligned with the longitudinal axis of the non-rotatable wire guide.

4. The catheter system according to claim 2, wherein, The blade has a proximal end, a distal end, a height, and a width.

5. The catheter system according to claim 4, wherein, The height of at least one of the plurality of blades increases from the distal end to the proximal end of the at least one of the plurality of blades.

6. The catheter system according to claim 4, wherein, The width of at least one of the plurality of blades increases from the distal end of the at least one of the plurality of blades to its proximal end.

7. The catheter system according to claim 1, wherein, The balloon catheter is configured to be positioned within the venous system of the subject and adjacent to an obstruction at a determined location, wherein the inflatable member is configured to be inflated within the venous system; The aspiration catheter is configured to be positioned within the venous system of the subject. The non-rotatable wire guide is configured to be positioned within the subject's venous system, wherein the cutting head is configured to be positioned adjacent to the obstruction. The balloon catheter or the aspiration catheter is configured to introduce fluid into the balloon catheter or the aspiration catheter; and The non-rotatable filament guide is configured to aspirate the fluid during the translation of the cutting head.

8. The catheter system according to claim 7, wherein, The cutting head is configured to be repositioned.

9. The catheter system according to claim 7, wherein, The suction conduit is configured for suctioning fluid.

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