Devices and methods for removing obstructive material from intravascular site

Abstract

To provide systems for removing an embolic material from an intravascular site.SOLUTION: A system 2401 includes: an elongate, flexible tubular body, having a proximal end, a distal end, and a tubular side wall that defines at least one lumen extending axially therethrough; an axial restraint device carried by the side wall and exposed to the lumen; a rotatable core wire 2410 extendable through the lumen, the core wire having a distal end; a limiting device carried by the core wire, the limiting device having a bearing surface for rotatably engaging the restraint device; and an agitator tip on the distal end of the core wire. The limiting device and the restraint device are engageable to permit rotation of the core wire but limit distal advance of the tip relative to the tubular body.SELECTED DRAWING: Figure 24-2

Description

[Background technology]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. Provisional Application No. 62 / 665,369, filed May 1, 2018. The benefit of which is claimed, and the entirety of that application is incorporated herein by reference.

[0002] Stroke is the third leading cause of death and the most disabling neurological disorder in the United States. Approximately 70 0,000 patients suffer from stroke. Stroke is a localized complication of the central nervous system. It is a syndrome characterized by the acute onset of neurological deficits lasting at least 24 hours, reflecting Stroke is the result of impaired cerebral circulation. Its incidence increases with age. Risk factors for stroke include: Systolic or diastolic hypertension, hypercholesterolemia, smoking, heavy alcohol consumption, and oral contraceptives Examples include the use of.

[0003] Hemorrhagic stroke accounts for 20% of the annual stroke population. Hemorrhagic stroke is caused by aneurysms and arteriovenous pulmonary arteries. The vascular malformation often ruptures and bleeds into the brain tissue, causing a cerebral infarction. The remaining 80% of strokes ischemic stroke, which occurs when a blockage in a blood vessel deprives the brain of oxygen-carrying blood. Ischemic stroke occurs when an embolus or piece of thrombotic tissue breaks off from a blood vessel in the brain and spreads to other areas of the brain. This is often caused by occlusion of a narrow cerebral artery distal to the occlusion site. Patients may experience neurological symptoms and signs. If symptoms appear and disappear completely within an hour, it is called a transient ischemic attack (TIA). Etiologically, TIA and stroke share the same pathophysiological mechanisms. and thus represents a continuum based on the persistence of symptoms and the extent of ischemic damage. There are.

[0004] Emboli can form around the heart valves or in the left atrial appendage during an irregular heart rate. These emboli can then migrate to the brain, where they then break off and travel with the bloodstream to distal areas of the body. As discussed below, many of these blockages can result in embolic stroke. occurs in the middle cerebral artery (MCA), but it is not the only site of emboli.

[0005] If the patient presents with neurological deficits, review the patient's medical history, stroke risk factors, and neurological examination. Based on the diagnostic tests, a diagnostic hypothesis regarding the cause of the stroke can be made. If a thromboembolic event is suspected, the clinician should consider whether the patient has a cardiogenic embolic cause, extracranial or intracranial disease of the aorta. whether the patient has pulmonary artery disease, intraparenchymal disease of small arteries, or hematologic or other systemic disease A head CT scan can be used to provisionally assess whether the patient is suffering from ischemic or hemorrhagic injury. This is often done to determine whether or not the patient has sustained an injury. With intraventricular hemorrhage, blood may be present on a CT scan.

[0006] Traditionally, emergency management of acute ischemic stroke has consisted of general supportive care, e.g., hydration, neurological from monitoring of clinical status, blood pressure control, and / or antiplatelet or anticoagulant therapy In 1996, the Food and Drug Administration approved Genentech's (Genentech Inc) tissue plasminogen activator, a thrombolytic drug - (t-PA) i.e. Activase (registered trademark) approved for use The National Institute of Neurological Disorders and Neuropathy and t-PA Stroke Study, a randomized, double-blind trial, In patients who received t-PA intravenously within 3 hours of the onset of stroke, the stroke rate was 24 hours higher. The scale scores were statistically significantly improved. For the first time, emergency room physicians can offer stroke patients effective treatment beyond supportive care. I was able to do it.

[0007] However, treatment with systemic t-PA reduces the risk of intracerebral hemorrhage and other bleeding complications. Patients treated with t-PA were associated with an increased Patients with tP >3 hours after stroke onset were more likely to sustain symptomatic intracerebral hemorrhage. Administration of t-PA increases the frequency of symptomatic intracerebral hemorrhage. Besides the time constraints on its use, other contraindications include: the patient has had a prior Patients who have had a stroke or severe head trauma or have contractions of 185 mmHg or greater Patients had a mean blood pressure of 110 mmHg or higher or a diastolic blood pressure of 110 mmHg or higher. Patients may need aggressive therapy to lower their blood glucose levels to the lower limit, or may be taking anticoagulants. have a history of pulmonary embolism or bleeding tendency, and / or the patient has recently undergone an invasive surgical procedure Therefore, only a small proportion of selected stroke patients receive t-PA. Eligible.

[0008] For many years, occlusive emboli have been mechanically removed from various sites in the vascular system. Mechanical therapies include clot capture and removal, clot lysis, clot disruption and aspiration, and / or This involves the creation of a channel through the clot. One of the devices is the Merci Retriever System. stem (Concentric Medical ), Redwood City, California. To access the internal carotid artery (ICA) from the femoral artery, a balloon-tipped guide is used. A microcatheter is placed through the guide catheter, and This is used to deliver a coiled-tip retriever across the clot and then The microcatheter is then pulled back to place the retriever around the clot. The balloon is inflated and a syringe is connected to the balloon guide catheter to allow for gait retention during clot retrieval. While aspirating the guide catheter, insert the microcatheter and retriever into the balloon guide catheter. The device is then pulled back into the catheter to finally extract the clot. Initially, good results were obtained.

[0009] Other thrombectomy devices include expandable frameworks, baskets, or snares. ) to capture and retrieve the clot. Temporary stents are used as stentreakers or reperfusion catheters. Sometimes called a device, it is used to remove or retrieve blood clots and restore blood flow in blood vessels. There are also a range of devices that use active laser or ultrasound energy to break up blood clots. Other active energy devices use intra-arterial blood to promote the dissolution of blood clots. Many of these devices are used in conjunction with the injection of thrombolytic agents to help dislodge blood clots and reduce the risk of embolism. It is used in combination with aspiration to reduce the risk of clot aspiration. However, it has also been used in single lumen catheters, syringes, and suction pumps. A device that applies a vortex of injected fluid in combination with suction may improve the effectiveness of this thrombectomy procedure. Finally, balloons or stents have been used to dislodge or dissolve blood clots. It has been used to create a patent lumen through the clot when this is not possible.

[0010] Notwithstanding the above, acute ischemic stroke and occlusive cerebrovascular disease in the body are also known as vascular occlusions. There remains a need for new devices and methods for treating blockages. Summary of the Invention [Means for solving the problem]

[0011] In accordance with one aspect of the present invention, a system for removing embolic material from an intravascular site is provided. The system includes a proximal end, a distal end, and a tubular sidewall extending axially therethrough. an elongated, flexible tubular body having a tubular sidewall defining at least one lumen extending therefrom; an axial restraint device supported by the wall and exposed to the lumen; a rotatable core wire having a proximal end and a distal end; a limiting device having a bearing surface that rotatably engages the restraining device; and and a stirrer tip, the limiting device and the restraining device permitting rotation of the core wire but not The tip is engageable to limit distal advancement of the tip relative to the tubular body.

[0012] The axial restraint device is supported by a radially inwardly extending projection or annular flange. The restriction device may include a proximally facing bearing surface that is adapted to engage the proximal end of the restriction device. The distal end of the proximal end of the shaft may include a distally facing bearing surface supported by the proximal end of the shaft. The extending protrusion supports a slider configured for sliding contact with the inner surface of the tubular side wall. Some implementations may include at least one spoke supporting each slider. The bearing surface may include three spokes that are spaced apart from each other to facilitate positioning of the tubular body within a tortuous vasculature. In response to being pressed, the agitator tip is prevented from distal advancement beyond the tubular body.

[0013] In some implementations, the restriction device includes an annular ring. The annular ring extends from the core wire. At least two spokes may be provided, the spokes extending from the core wire to the outer periphery of the core wire. In one implementation, three spokes may extend between the core wire and the ring. The restriction device extends between the proximal and distal rings. % range.

[0014] A flow passage is defined between each adjacent pair of spokes and in communication with the central lumen. The device has three flow channels, the total cross-sectional area of ​​which is 1 cm proximal to the restraint device. Approximately [90% or 95%] of the cross-sectional area of ​​the lumen within the range.

[0015] The core wire is approximately 30% of its larger diameter at the proximal point and 30% of its larger diameter at the restrictor. The core wire may be tapered to the smaller diameter of the restriction device. The core wire may be tapered to a smaller diameter that is no greater than about 18% of the proximal diameter. From a diameter of about 0.025 inches at the point to a diameter of less than about 0.005 inches at the restrictor It may also be formed into a groove.

[0016] The stirrer tip may include a helical thread. The helical thread is adapted to fit the inner diameter of the lumen. and forming an annular passage between the tip and the inner surface of the side wall. The helical thread may have a blunt outer edge. a helical passage between adjacent threads, and a cross-sectional area of ​​the helical passage and a cross-sectional area of ​​the annular passage are The sum of the above is at least about 10%, or about 20%, or more than about 10% of the cross-sectional area of ​​the lumen without the tip. or about 25% or more.

[0017] At least one helical spring coil is supported by the core wire and extends from about 5 cm to The spring may extend proximally from the tip for a length in the range of about 60 cm. The distal end may extend proximally from the distal end to a length in the range of between about 40 cm and about 50 cm.

[0018] The core wire may be permanently positioned within the tubular body or may be removable within the tubular body. It may be reliably positionable.

[0019] In accordance with a further aspect of the present invention, a method for the removal of blood from a blood vessel using mechanical and suction assistance is provided. A method for removing embolic material is provided, the method comprising: providing a catheter; and advancing a distal end to the occlusive material within the blood vessel. and rotating the tip within the lumen, wherein the tip is rotated axially by no more than about 5 mm. A helix having a length and an outer thread diameter at least about 0.015 inches less than the inner diameter of the lumen. providing a suction channel around the exterior of the tip having a tubular thread; and applying a vacuum to the lumen. and rotating the tip to draw the material into the lumen.

[0020] The rotating step involves manually rotating a core wire extending through the catheter to rotate the distal end The method further includes rotating the slide with a restraining device positioned within the central lumen. The core wire is supported by a restricting device that is in dynamic contact with the restricting device and rotates. The method may include limiting distal advancement of the ear.

[0021] In accordance with another aspect of the present invention, a method for aspirating a vascular obstruction from a remote site is provided. The method includes advancing an elongated tubular body through a vascular access site to a vascular occlusion. a tubular body having a proximal end, a distal end, a central lumen, and a lumen extending from the tubular body. and a stop device; and advancing a rotatable core wire distally through the lumen, The core wire is advanced until a limiting device supported by the core wire slidably engages a stop. The rotatable bearing limits further distal advancement of the core wire within the lumen. applying a vacuum to the lumen and rotating the core wire to drive the thrombus into the lumen. and a attracting step.

[0022] The step of applying a vacuum may include applying a pulsed vacuum. The step of advancing the tubular body over the guidewire without any intervening tubular body may include The step of advancing the tubular body may be accomplished by directly advancing the tubular body through at least the cancellous bone of the internal carotid artery. The cerebral division of the internal carotid artery may be distal to the cerebral division, or at least distal to the cerebral division of the internal carotid artery.

[0023] The step of advancing the rotatable core wire may include advancing the elongated tubular body to the vascular access site. This may be accomplished after the step of advancing the catheter through the rotatable catheter to the vascular occlusion. The step of advancing the core wire includes passing the elongated tubular body through the vascular access site. This may be accomplished simultaneously with the step of advancing to the ductal obstruction.

[0024] In accordance with one aspect of the present invention, a beveled, atraumatic navigation tip is provided. A neurovascular catheter is provided having a proximal end, a distal end and a central lumen. The distal zone of the tubular body includes a tubular inner wall defining a distal end of the tubular body. a side liner; a helical coil surrounding the inner liner and having a distal end; and a tubular jacket surrounding the helical coil and extending distally beyond the distal end of the catheter; and a tubular jacket terminating at a distal surface of the tubular radiopaque marker. The coil is embedded in a tubular jacket between the distal end and the distal face. The distal face is approximately 3 lies on a plane that intersects the longitudinal axis of the tubular body at an angle within the range of 5 degrees to about 55 degrees; The proximal surface is generally perpendicular to the longitudinal axis and extends at an angle within a range of about 35 degrees to about 55 degrees. and a distal surface lying in a plane transverse to the longitudinal axis. The distal surface extends from the rear edge of the tubular body to The distally extending tubular body defines a leading edge and a training edge. g edge) are spaced approximately 180 degrees from each other about the longitudinal axis.

[0025] The forward advancement section of the tubular body extends distally beyond the marker band. The leading edge of the tubular body may have an axial length in the range of about 1 mm to about 3 mm. may be greater than the length of the forward moving section on the trailing edge side of the tubular body.

[0026] The axial length of the marker band on the leading edge side of the tubular body is the axial length of the marker band on the trailing edge side of the tubular body. The axial length of the marker band on the leading edge side of the tubular body may be at least about 20% longer than The marker band may be in the range of 1 mm to about 5 mm. The marker band has at least one axial slot. Includes .

[0027] The tubular liner may be formed by dip coating a removable mandrel. The tubular liner may comprise PTFE. The tubular body comprises an inner liner and a spiral coil. The tie layer may further comprise a wall thickness of about 0.005 inches or less. and may extend along at least the distal most 20 cm of the flexible body. .

[0028] The coil may include Nitinol and may be austenitic at body temperature. The outer jacket may include at least five axially adjacent pieces. In some implementations, the outer jacket may be formed from separate tubular sections. The proximal end of the tubular segment may be formed from at least nine individual adjacent tubular sections. The difference in durometer between the distal end of the tubular segment and the distal end of the tubular segment is at least about 20D. and in some implementations, the distance between the proximal tubular segment and the distal tubular segment is The difference in durometer between them is at least about 30D.

[0029] The tubular body further includes a tension support for increasing tension resistance in the distal zone. The tension carrier may include an axially extending filament. The extending filament may be supported between an inner liner and a helical coil. The filaments extending in the direction increase the tensile strength of the tubular body to at least about 2 pounds before failure. may be increased by

[0030] Any feature, structure, or step disclosed herein is intended to be included in the Substitute or combine with any other features, structures, or steps Further, for purposes of summarizing the disclosure, embodiments may be Certain aspects, advantages, and features of the present invention have been described herein. Any and all may be accomplished in accordance with any particular embodiment disclosed herein. It will be understood that no particular aspect of the present disclosure is essential. Further features and advantages of the embodiments are set forth in the accompanying drawings and are not essential. It will be apparent to those skilled in the art in light of the following detailed description when considered in conjunction with the claims. Let it be. [Brief description of the drawings]

[0031] [Figure 1] FIG. 1 is a side elevational schematic view of an intracranial aspiration catheter according to the present invention, with the distal section in a proximally retracted configuration. [Diagram 2] FIG. 2 is a side elevational view similar to FIG. 1, with the distal section in a distally extended configuration. [Diagram 3] 3A and 3B are cross-sectional elevational views of the distal end of catheter 10 with distal section 34 fully extended. [Figure 4-1] Figures 4A-C show schematics of different cutting tip configurations, while Figures 4D-E and 4J-K show schematics of distal dynamic funnel tip configurations. [Figure 4-2] Figures 4F-4G show a dynamic flared tip with a first constraint system, and Figures 4H-4I show a dynamic flared tip with an alternative constraint system. [Diagram 5] FIG. 5 shows the cerebral arterial vasculature including the Circle of Willis and an access catheter positioned at the occlusion of the left carotid siphon. [Figure 6] FIG. 6 shows the sequence of steps involved in positioning the catheter and aspiration of occlusive material from the middle cerebral artery. [Figure 7]FIG. 7 shows the sequence of steps involved in positioning the catheter and aspiration of occlusive material from the middle cerebral artery. [Figure 8] FIG. 8 shows the sequence of steps involved in positioning the catheter and aspiration of occlusive material from the middle cerebral artery. [Figure 9] FIG. 9 shows the sequence of steps involved in positioning the catheter and aspiration of occlusive material from the middle cerebral artery. [Figure 10] FIG. 10 illustrates removal of the catheter after aspiration of the occlusive material. [Figure 11-1] 11A and 11B illustrate a series of steps for accessing a neurovascular occlusion for aspiration. [Figure 11-2] 11C and 11D illustrate a series of steps for accessing a neurovascular occlusion for aspiration. [Figure 11-3] 11E and 11F illustrate a series of steps for accessing a neurovascular occlusion for aspiration. [Figure 12-1] 12A and 12B illustrate an alternative sequence of steps according to an embodiment of the invention involving accessing a neurovascular occlusion for aspiration. [Figure 12-2] 12C and 12D illustrate an alternative sequence of steps according to an embodiment of the invention involving accessing a neurovascular occlusion for aspiration. [Figure 12-3] 12E and 12F illustrate an alternative sequence of steps according to an embodiment of the invention involving accessing a neurovascular occlusion for aspiration. [Figure 13] FIG. 13 illustrates an aspiration system configured to apply pulsed negative pressure through a suction catheter. [Figure 14] FIG. 14 illustrates an alternative aspiration system configured to apply pulsed negative pressure through a suction catheter. [Figure 15] FIG. 15 illustrates a further alternative suction system configured to apply mechanical vibrations through a suction catheter. [Figure 16]FIG. 16 illustrates a further alternative suction system configured to apply mechanical vibrations through a suction catheter. [Figure 17] FIG. 17 illustrates a further alternative suction system configured to apply mechanical vibrations through a suction catheter. [Figure 18] FIG. 18 illustrates a further alternative aspiration system having an agitator configured to apply mechanical vibrations at a vibration zone on the aspiration catheter. [Figure 19] FIG. 19 illustrates a simplified agitator, for example a wire supported by a hypotube, positioned within a catheter to form a vibration zone. [Figure 20-1] 20A-20C illustrate agitators having various distal tip configurations. [Figure 20-2] 20D and 20E illustrate a stirrer located within the distal funnel-shaped tip of the swellable polymer. [Figure 21] 21A and 21B show the distal tip of the catheter moving or meandering in response to actuation of the agitator. [Figure 22] 22A and 22B show media injection from the distal tip of a moving or meandering stirrer. [Figure 23-1] 23A and 23B show injection of media from the distal tip of the stirrer to assist with aspiration. [Figure 23-2] FIG. 23C illustrates a proximal suction port supported by a catheter. [Figure 24-1] Figure 24A is a side elevational view of a catheter having an internal stop ring, and Figure 24B is a longitudinal cross-sectional view through the catheter of Figure 24A with detail of the stop ring. [Figure 24-2] FIG. 24C is a side elevational view of a stirrer having a complementary limiting device for engaging the stop ring of FIGS. 24A and 24B. [Figure 24-3] Figure 24D is a side elevational view of a distal portion of the stirrer of Figure 24C, and Figure 24E is a longitudinal cross-sectional view through the stirrer of Figure 24D. [Figure 24-4]FIG. 24F is a cutaway perspective view of a distal portion of the stirrer of FIG. 24C. [Figure 24-5] Figure 24G is a cross section through a distal stopper supported by a stirrer, and Figure 24H is a cross section through an alternative distal stopper. [Diagram 25] 25A-25C illustrate a pulsed aspiration cycle according to an embodiment. [Figure 26] FIG. 26 illustrates a perspective view of the rotating hemostatic valve and proximal drive assembly. [Figure 27] Figure 27A shows a longitudinal cross-sectional elevation view taken along line 27A-27A of Figure 26. Figure 27B shows an enlarged longitudinal cross-sectional elevation view of the proximal drive assembly 2602 of Figure 27A. [Figure 28] FIG. 28 shows a cross-sectional perspective view of the proximal portion of FIG. [Figure 29] FIG. 29 shows a perspective view of the agitator driver, proximal drive assembly, and rotary hemostasis valve. [Diagram 30] FIG. 30 shows a cross-sectional elevation view of a catheter wall according to an embodiment. [Figure 31-1] Figure 31A shows a cross-sectional elevational view of a catheter wall according to another embodiment, showing one or more axially extending filaments. Figure 31B depicts a side elevational view of the catheter of Figure 31A. Figure 31C shows a cross-sectional view taken along line CC of Figure 31B, showing one or more axially extending filaments. [Figure 31-2] FIG. 31D is a side cross-sectional elevation view through the beveled tip of the distal catheter or extension tube. [Diagram 32] Figure 32A illustrates a side elevational view of a catheter according to one embodiment. Figure 32B depicts a cross-sectional elevational view taken along line AA of Figure 32A. Figure 32C shows a cross-sectional view taken along line BB of Figure 32A. [Diagram 33]Figure 33A shows a side elevational view of a catheter according to another embodiment. Figure 33B depicts a cross-sectional elevational view taken along line AA of Figure 33A, showing one or more axially extending filaments. Figure 33C depicts a cross-sectional view taken along line BB of Figure 33A, showing one or more axially extending filaments. [Diagram 34] Figure 34A illustrates a side elevational view of a progressively more flexible catheter according to one embodiment, and Figure 34B illustrates a proximal end view of the more flexible catheter of Figure 34A. [Diagram 35] FIG. 35 illustrates a back-up support for a catheter according to the present invention. [Diagram 36] FIG. 36 illustrates a graph of the elastic modulus or durometer of the catheter along its length, from the proximal end to the distal end. [Figure 37] FIG. 37 illustrates a graph of the bend test profile of a catheter according to the present invention compared to a conventional catheter. [Figure 38] FIG. 38 is a schematic side elevational view of a deformable catheter according to the present invention. [Figure 39] FIG. 39 is a cross-sectional view taken along line 18-18 of FIG. 38, showing the heating components within the catheter sidewall. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0032] Referring to FIG. 1, a catheter 10 according to one embodiment of the present invention is disclosed. Although described in the context of an axially expandable distal segment aspiration catheter having a central lumen, the present The catheter of the invention can be easily modified to incorporate additional structures, and as such The structure may, for example, be a permanent or removable column strength enhancing mandrel, a drug, a contrast agent, or or an inflatable balloon supported by a catheter that allows for the infusion of irrigation fluid. two or more lumens, such as for supplying inflation media to the and the like, which will be readily apparent to those skilled in the art in light of the disclosure herein. In addition, the present invention is primarily directed to removing occlusive material from remote vasculature in the brain. Although described in the context of aspiration, it can also be used with a variety of diagnostic or therapeutic devices, with or without suction. The catheter has potential applications as an access catheter for delivery and removal in any location. is.

[0033] The catheters disclosed herein have a larger diameter proximal section leading to a low profile Wherever it may be desirable to advance the distal catheter section distally, For example, shafts according to the invention may be easily adapted for use in a variety of applications. The catheter shaft, which can be extended or retracted in any direction, is ideal for use in the coronary and peripheral vasculature, gastrointestinal tract, urethra, and ureter. , fallopian tubes, and other lumens, and dimensions suitable for use throughout any conceivable lumen. The telescopic structures of the present invention may also be used for minimally invasive percutaneous tissue access, e.g. Diagnostic or therapeutic to a target (e.g., breast or liver or brain biopsy or tissue resection) for intraoperative access, delivery of laparoscopic instruments, or for the delivery of screws, bone cement or other Used to provide access to bones such as the spine for delivery of instruments or implants It is possible.

[0034] Catheter 10 generally comprises an elongated tubular body 1 extending between a proximal end 12 and a distal working end 14. The length of the tubular body 16 depends on the desired application. For example, it may be from about 120 cm to about 1 Region lengths of 40 cm or greater are suitable for use in percutaneous transluminal coronary applications with femoral access are typical. Intracranial or other applications may be used in blood vessels, as would be understood in the art. Depending on the vascular access site, different catheter shaft lengths may be required.

[0035] In the illustrated embodiment, the tubular body 16 includes at least a fixed proximal section 33 and a transition section 34. The distal section 32 is divided into an axially extendable and retractable distal section 34 separated by a distal portion 32 . FIG. 2 is a side elevational view of the catheter 10 shown in FIG. 1 with the distal section in a distally extended configuration. It has become.

[0036] 3A and 3B, a distal section extending distally from a proximal section 33 in accordance with the present invention. A cross-sectional view of distal section 34 is shown. Distal section 34 extends between a proximal end 36 and a distal end 38. and defining at least one elongated central lumen 40 extending axially therethrough. Distal end 38 may include one or more movable side walls or jaws 39. , which, under the influence of suction, move laterally towards the opposing side wall or jaw 41, The distal end 38 can bite or break down the thrombus or other material into smaller particles. The walls 39, 41 are formed to allow the blood vessel to be easily suctioned through the lumen 40. and may be movable towards or away from each other to For certain applications, the proximal section 33 may be Additionally or alternatively, the device may fragment thrombi in response to vacuum or mechanical actuation. The clamping mechanism may have one or two opposing jaws for clamping.

[0037] The inner diameter of the distal section 34 is between about 0.030 inches and about 0.112 inches, about 0.040 Between about 0.102 inches and about 0.045 inches and about 0.097 inches, about 0 Between .050 inches and about .092 inches, between about .055 inches and about .087 inches Between about 0.060 inches and about 0.082 inches Between about 0.062 inches and about 0.080 Between about 0.064 inches and about 0.078 inches, between about 0.066 inches and about 0 Between .076 inches, between about .068 inches and about .074 inches, or about .07 It may be between 0 inches and about 0.072 inches.

[0038] The inner and outer diameters of the distal section 34 are constant or substantially constant along its longitudinal length. Alternatively, the distal section 34 may be tapered near its distal end. The distal section 34 may be about 5 cm, about 10 cm, about 15 cm, about 20 cm, or about 30 cm from its distal end. cm, approx. 23cm, approx. 25cm, approx. 30cm, approx. 31cm, approx. 35cm, approx. 40cm, approx. It tapers at 45cm, 50cm, 60cm, or 70cm or less. In some embodiments, the taper extends from about 25 cm from the distal end of the distal section 34. and about 35 cm.

[0039] The inner diameter of the distal section 34 may be about 95%, about 90%, about 85%, about 8% or about 10% of the adjacent pre-modification inner diameter. 0%, about 75%, about 70%, about 65%, about 60%, about 55%, or about 50% or less The inner diameter may taper or decrease distally near the distal end. In some embodiments, the inner diameter of the tapered distal section 34 is about 5 times smaller than the adjacent unmodified inner diameter. For example, the distal section 34 may be tapered at its proximal end. The inner diameter may be approximately 0.071 inches, with a tapered inner diameter at the distal end of the distal section 34. The diameter may be about 0.035 inches, about 0.045 inches, or about 0.055 inches. The inner diameter of the distal section 34 is about 102% of the inner diameter just proximal to the tapered transition, about The tape is tapered near the distal end by 104%, about 106%, about 108%, or more. The tapered inner diameter of the distal section 34 may be tapered or increased by about 0.1 1 inch, 0.1 inch, 0.090 inch, 0.080 inch, 0.070 inch inch, 0.065 inch, 0.060 inch, 0.055 inch, 0.050 inch inch, 0.045 inch, 0.040 inch, 0.035 inch, 0.030 inch inch, about 0.025 inch, about 0.020 inch, about 0.015 inch, or about 0.0 In some embodiments, the distal taper of the distal section 34 may be 10 inches or less. The length of the shaped part is between about 25cm and about 35cm, between about 25cm and about 30cm, and about 30cm. It may be between cm and about 35 cm, or approximately 30 cm.

[0040] The length of the distal section 34 may be between about 13 cm and about 53 cm, between about 18 cm and about 48 cm, Between about 23cm and about 43cm, between about 28cm and about 38cm, between about 29cm and about 39cm between about 30cm and about 40cm, between about 31cm and about 41cm, or between about 32cm and about The length of the distal section 34 may be between about 20 cm, about 25 cm, about 30 cm, about 42 cm, or about 50 cm. cm, approx. 33cm, approx. 35cm, approx. 40cm, approx. 41cm, approx. 45cm, approx. 50cm, approx. Distal section 3 may be less than 55 cm, about 60 cm, about 70 cm, or about 80 cm. The length of 4 may depend on the degree of tapering of the inner diameter of the distal section 34.

[0041] The proximal end 36 of the distal section 34 includes a puller wire 42 extending proximally. The wires 42 are connected to a control device 24 which may be supported by the manifold 18. The axial movement of the control device 24 will be discussed. , resulting in corresponding axial movement of the distal section 34 relative to the proximal section 33. The proximal end of the withdrawal wire 42 may exit through a port on the manifold 18. This allows the clinician to manually grasp the proximal end and pull or push it in to access the distal The length of the pull wire 42 is adapted to extend or retract the distal section 34. Between about 700mm and about 1556mm, between about 800mm and about 1456mm, about 850mm Between about 900mm and about 1356mm, Between about 950mm and about 1306 mm, between about 1000mm and about 1256mm, between about 1020mm and about 1236mm , between about 1040mm and about 1216mm, between about 1060mm and about 1196mm, Between 80mm and 1176mm, between 1100mm and 1156mm, 1110mm and about 1146 mm, or between about 1120 mm and about 1136 mm.

[0042] When the puller wire 42 is advanced distally to its limit of travel, the proximal end 36 of the distal section 34 and An overlapping portion 44 remains between the proximal section 33 and the distal section 34. The overlapping portion 44 is It is configured to provide a seal to allow efficient transfer of vacuum to the compartment 34 . The overlapping portion 44 may have various configurations to facilitate sealing, as described elsewhere herein. Additional features such as gaskets, coatings, or tight tolerance sliding fits may be provided. Preferably, there is a clearance between the OD of the distal section 34 and the ID of the proximal section 33. The lance is preferably sized to provide an effective seal in the blood environment, at least near the transition 32. It will be about 0.005 inches or less, and preferably about 0.003 inches or less. In embodiments including sealing features as described herein, even greater clearances may be required. It's even more likely to be achievable.

[0043] Following positioning of the distal end of the proximal section 33 within the vasculature, such as within the cervical carotid artery, a control 24 is manipulated to advance distally the distal section 34 deeper within the vasculature. For this purpose, the puller wire 42 is disposed distal to the distal tip 38, as discussed below. This provides sufficient column strength to allow for forward movement.

[0044] The puller wire 42 and the distal section 34 are connected to the catheter as illustrated in FIGS. Alternatively, the distal section 34 and the puller wire 42 may be , which is configured as a stand-alone catheter extension device, as discussed in more detail below. The catheter extension device may be introduced into the proximal end of the proximal section 33 after placement of the proximal section 33. 3A, and may be advanced distally therethrough, as shown in FIG. Elastically extend the reach of your system.

[0045] Referring to FIG. 3B, the puller wire 42 is a tube having a central lumen 45 extending axially therethrough. The central lumen 45 may include a tubular wall. 34. Additionally, a central lumen extending through the puller wire 42 is provided. 45 allows for the introduction of a stirrer, as will be discussed in more detail below. As shown in FIG. The central lumen 45 may open into the lumen 40. The distal opening of the central lumen 45 is , a point along the length of the distal section 34 such that the central lumen 45 ends where the lumen 40 begins. (The distal opening of central lumen 45 may be longitudinally aligned with the proximal opening of lumen 40. The proximal opening of lumen 40 may be angled or In some embodiments, the opening of the lumen 40 may be flat. The distal opening of the central lumen 45 may be flat, as shown in FIG. In an embodiment, this opening is angled or inclined, similar to the opening of lumen 40 in FIG. 3B. It is okay to do so.

[0046] In some embodiments, the central lumen 45 terminates proximally towards the opening of the lumen 40. In some embodiments, the central lumen 45 may be an opening to the lumen 40 and / or may terminate distally toward the proximal end of the distal section 34 (e.g., at a point within the lumen 40). For example, the central lumen 45 may terminate at the distal end of the distal section or may be immediately adjacent to the distal end. It may terminate proximally (e.g., approximately 1 cm or less from the distal end). , the puller wire 4 extends beyond the proximal end of the distal section 34 (e.g., into the lumen 40). The second section has a reduced distal stiffness (durometer) with or without a central lumen 45. The puller wire 42 is preferably provided to provide sufficient pushability of the elongated catheter. Additionally, the distal section 34 may be relatively stiff along a proximal portion toward the proximal end thereof. The stiffness of the portion of the puller wire 42 distal to the proximal end of the section 34 varies with the length of the distal section 34. The stiffness of the distal section 34 may be substantially equal to or less than that of the distal section 34 along the The portion of the puller wire 42 distal to the proximal end of the distal section 34 is The distal section 34 may have a uniform stiffness that is less than the stiffness of the proximal end of the distal section 34. The stiffness of the distal portion of the endoscopic catheter may be stepped or tapered in the distal direction, decreasing from the stiffness of the distal portion. For example, the puller wire 42 may extend along a portion proximal to the proximal end of the distal section 34. , and may include a metal along a portion distal to the proximal end of the distal section 34. In some embodiments, the distal end may include a more flexible polymer than the proximal end. The portion may be extruded to reduce stiffness in the distal direction.

[0047] 4A-4C, the distal tip 38 is adapted to receive an actuation force, such as a vacuum, within the lumen 40. Any of a variety of structures may be provided that respond to pressure to produce active movements, such as occlusal movements. Alternatively, an axially movable control wire can be connected to the side wall of the distal tip 38. , allowing a cutting action under a positive mechanical force. 4B shows the distal tip 38 being pulled together by negative pressure in the aspiration lumen 40. Illustrated is a distal tip 38 having opposed side walls 39 and 41 that are brought together. This can be achieved by providing side walls 39 and 41 with a tapered thickness or by providing side walls 39 and 41 with a tapered thickness. A groove or living hinge that facilitates lateral movement of at least one of the grooves 41 and 42. This may be achieved by providing a hinge.

[0048] Alternatively, referring to FIG. 4C, a pivot point or hinge 43 may be provided so that the side wall 39 The two opposing side walls may be movable laterally to act as jaws. Inner with bidirectional symmetry like duck bill valve Three or more jaws may be movable vertically and laterally, for example, closing under a suction pulse. Three triangles spaced approximately 120° apart that together form a pyramidal closed end. may be provided.

[0049] In some implementations of the present invention, the distal tip 14 is preferably sized to be 1 / 2" in diameter relative to the nominal diameter of the distal section 34. This allows for a cone-shaped catheter with an enlarged distal opening. A funnel-shaped tip is provided to facilitate the introduction of thrombotic material into lumen 40. See K. The diameter at the fully opened distal opening of the funnel is at least about 10%, preferably At least about 25%, or 45%, or more of the cylindrical extension of the adjacent tubular body. This is because the distal end 14 is provided with expandable material or laterally movable jaws. or petal-like structures, e.g., at least about 3, or 5, or 6, or more This may be achieved by providing petal-like structures on the jaws or petal structures. is capable of advancing radially inwardly and assuming a constrained orientation, and is radially outwardly The aspiration lumen 40 can be advanced in a divergent manner to increase in inner diameter in the distal direction. do.

[0050] The flexible petal-like structure may, for example, be adapted to move through the lumen 40 during transluminal navigation of the distal section 34. The radially inwardly tilted configuration may be maintained by application of negative pressure. When this occurs, the panel moves radially outward in response to a preset bias. The panels may then be closed radially inwards by application of a pulsed vacuum. 4 to perform the occlusion function described above.

[0051] The distal infundibulum opening can be opened by a variety of other methods, as will be apparent to those skilled in the art. It may be actuated, for example by a pull wire or an axially slidable outer or inner Providing a sleeve to open and close the funnel-like structure in response to mechanical movement of the wire or sleeve. Alternatively, the funnel opening may be provided by a control wire for the distal section 34. Throttling or spiral mechanisms controlled by the relative rotation of the ears or tubular sleeves, e.g. For example, a helical ribbon or wire supported by the distal tip may be actuated.

[0052] The normal state of the distal funnel may be a cylindrical configuration and may be mechanically, thermally, Alternatively, an electrical actuator may be used to enlarge the distal infundibulum opening. Alternatively, the normal state of the funnel may be conical, and the funnel may be mechanically, thermally, or or by using an electrical actuator to reduce the diameter, e.g., for transluminal navigation. The petals or other walls of the funnel-shaped structure or within the walls of the funnel-shaped structure may be The components are made of shape memory materials, such as shape memory polymers, or nitinol (Ni The materials may include metal alloys such as tinol, which are available in stock tubes. It may be laser cut or woven into a fine mesh. The geometry of the catheter is influenced by heat, e.g., body temperature, or the interior of the wall or adjacent catheter tip. The catheter is supported by a heat source, such as an electrically resistive wire. Alternatively, heat may be provided by a heat source introduced through the central lumen 40, e.g., a heated The heater may be a flexible elongated body carrying a fluid or a removable heater, such as a resistive coil. Alternatively, the transformation of the funnel-shaped structure from one configuration to the other may be By lowering the temperature of the structure below body temperature, for example by introducing a chilled fluid, the leakage By being in thermal communication with the funnel tip, or near the catheter or distal end To provide a removable cooling catheter having a Joule-Thomson expansion chamber located at This may be achieved by:

[0053] In an alternative configuration, the sidewall of the funnel-shaped structure communicates with an inflation lumen that extends the entire length of the catheter; The balloon is inflatable in the form of a ring or annulus. The annular balloon is inflated by the introduction of inflation medium. The loon expands and the configuration of the funnel tip changes from a reduced diameter to an expanded diameter. To become.

[0054] In an alternative configuration, the distal tip may be biased into a funnel-shaped configuration and constrained to, for example, be inserted into a transluminal catheter. In cases where it is desirable to enlarge the tip of the funnel-shaped structure, In this case, the restraint device can be removed. The restraint device pulls the puller wire in the proximal direction. The outer tubular cover or ring structure is configured to be removable by pulling out the outer tubular cover or ring structure. Alternatively, the restraint device may reach its final intravascular location from the vascular access. a bioabsorbable material that dissolves after a preset amount of time that exceeds the expected time to may be also possible.

[0055] 4J-4K, the distal flared tip may be formed by embedding an elastic component (e.g., (e.g., coil, strut, or cage), e.g., spring steel, Nitinol, or Other biases known in the art may also be included to bias the splay configuration. An elastic component, in the form of a tinol cage or the like, may be present on the ID of the catheter. The polymer tip may constrain the elastic component to provide a transluminal Provides a cylindrical exterior structure for navigation. By softening the polymer (e.g., hydrophilic blend), the elastic component becomes As can be seen, the tip can be deformed into a funnel-shaped configuration. The cone-shaped NiTi cage is coated with a dual hydrophilic non-crosslinkable adhesive. The catheter is advanced. As the adhesive melts, the tip gradually widens to form a funnel shape. The ends may be formed without embedded elastic components and instead may be formed from multiple layers. and a coextrusion having varying thickness in the multiple layers and a hydrophilic component. Different ratios may be used to control the divergence. The catheter is then inserted into an extruded lumen that runs axially through the entire catheter wall. By pushing or pulling the wire, the distal end of the catheter opens. or closed, flared or collapsed. The tip region spans the high and low durometer regions, but The length of the blood vessel can be increased in the high durometer region. When the stent is ready to engage the stent, it is pushed further distally into the low durometer tip. After complete clot retrieval, the stent is pulled into the high durometer region. This is an example of an active on-demand funnel tip.

[0056] Referring to FIG. 4F, a cross-sectional view of the distal end of the tubular catheter body, e.g., distal section 34, is shown. The tubular body is a self-expandable (e.g., The restraining device 52 has a distal tip 38 in the form of a mesh 50 (e.g., nitinol). a proximal retractable tubular body extending proximally relative to a control device on the proximal manifold; A peelable sheath supported by an elongated puller wire, which may be a pull-away sheath, or as otherwise disclosed herein. As shown in FIG. 4G, the tubular body 34 may include other mechanisms for The restraining device 52 is proximally retracted or the tubular body 34 is distally advanced relative to the restraining device 52. This exposes and releases the mesh 50, which then self-expands into a funnel shape and dislodges the remaining part of the blood vessel. This facilitates capture and removal of the carcasses.

[0057] 4H and 4I, a self-expandable conical mesh 50 is provided with internal restraining wires. The wire 54 is a procedural guide wire. Proximal retraction of the restraining wire 54 allows the catheter to be inserted into the catheter 10. This releases the mesh 50 and allows it to self-expand into its final funnel-shaped configuration. may be achieved through a variety of alternative methods, such as bioabsorbable materials, electrolytic separation, etc.

[0058] The proximal end 12 of the catheter 10 may include one or more access ports, as is known in the art. The manifold 18 further includes a proximal end having a port. Ports, such as over-the-wire guidewires port 20 and at least one side port, such as a suction port 22. If a guidewire is inserted proximally from the guidewire port 20 following placement of the aspiration catheter, If the procedure involves removing the catheter and using aspiration through the guidewire port, the aspiration port Depending on the functional capabilities of the catheter, additional accessories may be added as necessary. Access ports and lumens may be provided. The manifold 18 is compatible with a variety of medical grade The molded article may be injection molded from any of a variety of plastics or by other techniques known in the art. The endothelial cell may be formed by surgery.

[0059] The manifold 18 includes a control device for controlling the axial position of the distal section 34 of the catheter. The control device 24 controls the mechanical structure and axial direction of the distal section 34. The embodiment shown may take any of a variety of forms depending on the desired range of movement of the actuator. In the embodiment, the control device 24 includes a slider switch that is mechanically axially movable. a slider switch 24 connected to the distal segment such that proximal retraction of the slider switch 24 moves the distal segment This causes the distal section 34 to move proximally as shown in FIG. As shown, the slider switch 24 retracts into the proximal section 33. The distal axial advancement of the slider switch 24 , resulting in distal axial advancement of the distal section 34, as shown in FIGS.

[0060] Switches, buttons, levers, rotatable knobs, pull / push wires, and Any of a variety of control devices, including others that will be apparent to those of skill in the art in view of the disclosure herein. The control device is generally coupled to the distal section by a control wire 42.

[0061] Alternatively, the proximal and distal sections 33, 34 may be provided as separate devices, In that case, the proximal control device may be omitted. The distal end of the proximal section 33 is adapted to prevent the passage of blood from a thrombus or other obstruction. Morsel or otherwise break the obstruction into pieces or otherwise aspirate it To facilitate this, the clamp may be provided with one or more jaws, as discussed earlier in this specification. In addition, the proximal section 33 may be configured to, for example, provide intermittent or pulsed ventilation as discussed elsewhere herein. Vibrational motion or May be mechanically coupled or adapted to couple to a source of rotational motion .

[0062] The clinician may perform axial and / or rotational and / or distal occlusal movements. In some cases, the proximal section 33 can be used to reach the obstruction using the technique. 5, in which the proximal section 33 is able to reach the obstruction in the left carotid siphon. However, it is not possible to advance the proximal section 33 sufficiently close to the obstruction. If not possible, a separate telescopic distal section 34 may be introduced into the proximal section 33, as shown in Figs. As illustrated, advance the device through or beyond the segment to reach the obstruction. It may be achieved.

[0063] Cerebral circulation is such that a constant total cerebral blood flow (CBF) is generally maintained under various conditions. For example, the flow to one part of the brain, such as in acute ischemic stroke, is regulated by The decrease may be compensated for by an increase in flow to another part of the brain, resulting in CBF to this region remains unchanged. More importantly, parts of the brain are vascularized. When an obstruction causes ischemia, the brain increases blood flow to the ischemic area through its collateral circulation. The compensation will be provided by

[0064] FIG. 5 illustrates the cerebral arterial vasculature, including the Circle of Willis. The aorta 100 is connected to the right brachiocephalic artery. 82, the left common carotid artery (CCA) 80, and the left subclavian artery 84. The brachiocephalic artery 82 gives rise to , which further branches into the right common carotid artery 85 and the right subclavian artery 83. The left CCA is the left internal carotid artery (I CA) 90, which is connected to the left middle cerebral artery (MCA) 97 and the left anterior cerebral artery (ACA) On the anterior side, there are the internal carotid artery, the anterior cerebral artery, and the anterior communicating artery connecting the two ACAs. The right and left ICAs form the right posterior communicating artery, which is connected to the right posterior communicating artery. artery 72 and the left posterior communicating artery 95 feed the right posterior cerebral artery (PCA) 74 and Connect to the left PCA 94. Two posterior communicating arteries, the PCA, and the posterior major artery from the basilar artery 92. The origin of the cerebral arteries completes the circulation posteriorly.

[0065] For example, as shown in FIG. 5, an occlusion occurs acutely at the left carotid siphon 70. When it occurs, it is in the right cerebral artery, the left external carotid artery 78, the right vertebral artery 76, and the left vertebral artery 77. Blood flow increases to compensate for the sudden decrease in blood flow in the left carotid siphon. , the direction of blood flow in the circle of Willis changes. Specifically, the right posterior communicating artery 72, the right P Blood flow is reversed in the CA 74 and left posterior communicating artery 95. The anterior communicating artery 91 opens, and the left AC The blood flow in A99 was reversed, and the blood flow in the left external carotid artery increased, causing blood flow along the left ophthalmic artery 75. All of these contribute to blood flow in the left ICA90 distal to the occlusion. and provide perfusion to the ischemic area distal to the occlusion.

[0066] As shown in FIG. 5, the proximal section of the catheter 10 may be threaded along a guidewire or It is then navigated transluminally to the proximal side of the occlusion. The distal section 34 of the catheter may be brought into a first, proximally retracted configuration. Proximal compartment 3 until further progression is hindered by small and / or tortuous vasculature. Alternatively, the distal section 34 may be a separate device and may be inserted into the proximal section 33. The proximal section 33 is inserted only after it is determined that the obstruction cannot be safely reached. In the example shown in FIG. 1, the proximal section 3 is inserted without the need to insert or extend distally the distal section 34. 3 can reach the obstruction safely.

[0067] The distal end of the proximal section 33 of the aspiration catheter 10 is typically inserted through an incision on a peripheral artery. The catheter is then inserted over the guidewire and further into the distal carotid or intracranial artery, e.g. No endovascular treatment was considered safe in the carotid artery, peripheral ICA, carotid siphon, MCA, or ACA. The site of occlusion can be localized by cerebral angiography or IVUS. In emergency situations, IVUS or standard carotid Doppler and TCD support may be used. After localizing the occlusion using a catheter, a catheter can be inserted directly into the symptomatic carotid artery.

[0068] Distal navigation of the proximal segment 33 sufficient to reach the occlusion can be safely achieved If not, the distal section 34 is inserted into the proximal port 20, and / or or beyond the proximal section 33 until the distal tip 38 is positioned adjacent the proximal end of the obstruction. and is extended distally.

[0069] 6, the occlusion 70 is retained in the middle cerebral artery 97. The proximal segment 33 is It is positioned within the ICA and passes a specific point, e.g., the branching point 96 into the MCA artery 97. The proximal section 33 has a distal section 34 supported therein, which cannot be navigated. Alternatively, if it is determined that the proximal section 33 alone cannot directly reach the obstruction 70, Once cut, a separate distal section 34 may be introduced into the proximal end of the proximal section 33. 8, the distal section 34 then forms a distal gap between the proximal section 33 and the obstruction 70. The catheter may be navigated transluminally through the tortuous vasculature of the distal extremity.

[0070] Referring to FIG. 9, the occlusion 70 is then inserted into the distal compartment, as discussed elsewhere herein. With or without the use of jaws or other actuation on the distal end of 34, a constant or The distal section 34 may be drawn into the distal compartment 34 by applying a constant negative pressure. As phlegm obstruction 70 is drawn into distal section 34 or as it is withdrawn proximally from the body, Once the distal section 34 is sufficiently drawn into the proximal section 33 so that the and the distal section 34 is withdrawn proximally.

[0071] Suction may be applied through lumen 40 in a constant or pulsed mode. Preferably, the pulsed application of suction causes the distal tip 38 to open and close like jaws. This can result in remodeling of the thrombus or occlusion or crushing of the thrombus material. 2. The catheter may be easily broken into threads or fragments to facilitate proximal removal under negative pressure through lumen 40. The application of suction may be accompanied by distal advancement of distal tip 38 into the thrombus material.

[0072] Pulsed application of vacuum can be between positive and zero vacuum, or between a first low negative pressure and a second low negative pressure. It may be oscillated between high negative pressures, or a slight positive pressure may be applied alternating with negative pressure. It is primarily the application of negative pressure that provides the net suction through lumen 40. Operation is discussed in further detail in relation to FIG.

[0073] A proximal manifold and / or a proximal control unit (not shown) connected to the manifold. (without pre-determining) allows clinicians to control pulse rate, pulse duration, timing between pulses, and Any of a variety of pulse parameters can be adjusted, including the strength of the pulsed vacuum. There may be cases.

[0074] The distal section may then be proximally retracted into the proximal section 33, and the catheter removed from the patient. Alternatively, proximal retraction of the catheter 10 may be performed to a distally extended position. This may be accomplished with a certain distal compartment 34. Troprusside was injected through the second lumen to treat vasospasm induced as a result of instrumentation. may be suppressed.

[0075] Pressure can be measured using a manometer supported by the catheter or a pressure gauge located within the lumen of the catheter. The pressure may be monitored by wires positioned in the pressure control device and display. It may be included in a proximal control unit within the catheter, or at the proximal end, which allows The suction in the container can be adjusted.

[0076] Focal hypothermia, which has been shown to be neuroprotective, was used to treat hypothermic oxygenated blood Moderate hypothermia at approximately 32-34°C can be achieved by infusing the body with hypothermia or fluid. can be introduced during the perfusion of fluid through a port on the manifold 18. The perfusion is performed by withdrawing venous blood from a peripheral vein and processing it through a pump oxygenator. or by drawing oxygenated blood from a peripheral artery, such as the femoral artery, and pumping it through This can be achieved by moving it back towards the carotid artery.

[0077] If attempts to dislodge the blockage with continuous and / or intermittent suction are unsuccessful, A lytic agent, such as t-PA, may be injected through the central lumen 40 or through a second lumen to provide a localized effect. Able to dissolve thrombotic material with greater and less systemic complications However, administration of thrombolytic agents increases the risk of bleeding, so it is recommended to insert the agent directly into the carotid artery. may not be recommended for devices that use

[0078] The intensity of the intermittent or pulsed vacuum applied to the lumen 40 may be adjusted to control the flow of the catheter 1. 0 is subjected to an axial reciprocating motion or water hammer effect. This may be used to remove or destroy obstructions as well as to facilitate transluminal navigation. Water hammer, or more commonly known Essentially, fluid hammer occurs when a moving fluid is forced to suddenly stop or change direction. Water hammer is a pressure surge or pressure wave that occurs when a change in flow rate occurs. This usually occurs when a valve at the end of a pipeline system suddenly closes, causing a pressure wave to propagate through the pipe. This occurs when a solenoid or valve closes, suddenly stopping the flow of fluid. When the pulse generator or other pulse generator is operating, a pressure surge or pressure wave occurs in the lumen 40 of the aspiration catheter 10. As the pressure wave propagates within the catheter 10, the catheter 10 is axially vibrated. The vibration can reduce the surface friction between the outer diameter of the catheter 10 and the inner diameter of the blood vessel wall, so that the catheter can follow through the tortuous anatomical structure and can also assist in thrombus capture.

[0079] Referring to FIGS. 11A-11F, the cerebral circulation 1100 is simplified to facilitate demonstration of the steps of the procedure The thrombotic occlusion 1102 is in the right middle cerebral artery (RMCA) 1104 . The RMCA 1104 branches from the right internal carotid artery (RICA) 1106 . The RICA 1106 branches from the right common carotid artery (RCCA) (not shown). The RICA 1106 includes segments of the cerebrum 1108 (the most distal from the aorta 100), the cavernous body 1110, and the pyramidal part 1112 ( the most proximal from the aorta 100). The RCCA branches from the brachiocephalic artery. The brachiocephalic artery

[0080] The steps of the procedure for aspirating the thrombotic occlusion are described below. Referring to FIG. 11A , an introducer sheath 1120 is introduced into the femoral artery 1118. The intro ducer sheath 1120 may have an outer diameter of about 12F, 11F, 10F, 9F, 8F, 7F, or 6 F or less. Next, a guide sheath 1122 is inserted through the introducer sheath 112 0. The guide sheath 1122 may have an outer diameter of about 9F, 8F, 7F, 6F, 5 F, 4F, or 3F or less, and the inner diameter of the introducer sheath 1120 may be larger than the outer diameter of the guide sheath 1122.

[0081] Referring to FIG. 11B, an insertion catheter 1124 is inserted through the guide sheath 1122. The outer diameter of the insertion catheter 1124 is about 9F, 8F, 7F, 6F, 5F, The inner diameter of the guide sheath 1122 may be 4F, or 3F or less, and the inner diameter of the guide sheath 1122 may be 4F, or 3F or less, 1124. In some embodiments, the outer diameter of the first guidewire 1124 may be larger than the outer diameter of the first guidewire 1124. 126 may be introduced through an insertion catheter 1124 (not shown in FIG. 11B). The guide sheath 1122, the insertion catheter 1124, and optionally the first guide The wire 1126 is then followed to the aortic arch 1114. The insertion catheter 1124 is inserted into the vascular In FIG. 11B, an insertion catheter 1124 is used to engage the origin of the brachiocephalic The catheter 1124 is inserted into the artery 82 and engages the origin 1116 of the artery 82. Prior to the angiography procedure, the first guide wire 112 is inserted. When using the 6th embodiment, the first guidewire 1126 is inserted prior to injecting the contrast agent. Remove.

[0082] Referring to FIG. 11C, a first guidewire 1126 is inserted through the tube of the insertion catheter 1124. Then, the first guide wire 1126 and the insertion catheter 1 124, and guide sheath 1122 are advanced together into the ICA 1106. Referring to FIG. 1, a typical guide sheath 1122 currently available on the market (e.g., Penumbra NeuroMax system manufactured by Penumbra Inc. Due to the rigidity of the MAX system, the guide sheath 1122 is forced to navigate The most distal blood vessel that can be reached is the petrous division 1112 of the ICA 1106. The guide wire 1126, the insertion catheter 1124, and the guide sheath 1122 are connected to the ICA1. 106, the first guidewire 1126 and the insertion catheter 1124 are Remove both.

[0083] Referring to FIG. 11E, within the central lumen of a reperfusion catheter 1130 (e.g., 3Max), A second guidewire 1132 is inserted into the aspiration catheter 1128 (e.g., an ACE The catheter is introduced through a guide sheath 1122 mounted in the central lumen of the catheter 68. The diameter of the second guidewire 1132 is about 0.03 inches, about 0.025 inches, about 0.0 2 inches, about 0.016 inches, about 0.014 inches, about 0.01 inches, or about 0. The inner diameter of the reperfusion catheter 1130 may be equal to or smaller than the second guidewire. The inner diameter of the suction catheter 1128 may be larger than the outer diameter of the ear 1132. The inner diameter of the guide sheath 1122 may be larger than the outer diameter of the catheter 1130. The outer diameter of the second guidewire 1128 may be larger than the outer diameter of the aspiration catheter 1128. 32 is advanced distally to position it at the proximal end of the clot 1102 within the MCA 1104.

[0084] Referring to FIG. 11F, the suction catheter 1128 is connected to the reperfusion catheter 1130 and Over the second guidewire 1132 to the proximal end of the clot 1102 in the MCA 1104 Both the second guidewire 1132 and the reperfusion catheter 1130 are Next, a vacuum is applied to the proximal end of the suction catheter 1128 to remove the suction catheter. The clot 1102 is aspirated through the central lumen of 1128 .

[0085] A preferred and simplified method for aspirating thrombotic obstructions in accordance with the present invention is shown in FIG. The alternative steps for aspirating thrombotic obstruction are described in Transition Guide A-12F. A transitional guide wire and transitional guide sheath are utilized. The transitional guide wire has a smaller diameter. The transition guidewire has a soft, trackable distal section that is adapted to support the distal end of the catheter, as shown in FIG. The transition guide wire 1126 can be advanced deeper than the transition guide wire 1126. The transitional guide sheath has a soft, trackable distal section and is shown in FIG. 11D. The guide sheath 1122 can be advanced deeper than the guide sheath 1122 that is mounted on the guide sheath 1122. The use of a transitional guidewire and transitional guide sheath that can be advanced to the area allows for Eliminates the need for a second guidewire or reperfusion catheter for access .

[0086] Referring to FIG. 12A, an introducer sheath 1220 is introduced into the femoral artery 1218. The outer diameter of the introducer sheath 1220 is approximately 12F, 11F, 10F, 9F, , 8F, 7F, or 6F or less. A transitional guide sheath 1222, such as a combination access and aspiration catheter, is inserted into the femoral artery. 1218 through the introducer sheath 1120. The outer diameter may be about 9F, 8F, 7F, 6F, 5F, 4F, or 3F or less. Referring to FIG. 12B, an insertion catheter 1224 is inserted through a transitional guide sheath 1222. The outer diameter of the insertion catheter 1224 is about 9F, 8F, 7F, 6F, 5F, The inner diameter of the transition guide sheath 1222 may be smaller than 4F or 3F, and the inner diameter of the transition guide sheath 1222 may be smaller than the insertion catheter. The outer diameter of the first guide wire 1224 may be larger than the outer diameter of the first guide wire 1224. The ear may be introduced through an insertion catheter 1224 (not shown in FIG. 12B). The diameter of the proximal section of the first guidewire is about 0.079 inches, about 0.066 inches, about 0.053 inches, approx. 0.038 inches, approx. 0.035 inches, approx. 0.030 inches, or about 0.013 inches or less.

[0087] A transition guide sheath 1222, an insertion catheter 1224, and optionally a first guidewire The catheter is then inserted into the aortic arch 1214. See FIG. 12B. In FIG. 12B, an insertion catheter 1224 is inserted into the arm. The angiography procedure is performed by inserting a catheter 1224 into the cephalic artery 82 at its origin 1216. This may be accomplished by injecting a contrast agent as needed. If a guidewire is used, the first guidewire is preferably removed prior to injecting the contrast agent.

[0088] Referring to FIG. 12C, a transition guidewire 1226 may be inserted into the insertion catheter 1224 or A small amount of the transition guide wire 1226 is inserted through the lumen of the guide sheath 1222. At least a portion of the diameter (e.g., the proximal diameter) is substantially the same as the diameter of the first guidewire 1126. The diameter of at least a portion of the transition guidewire 1226 (e.g., the distal straight The diameter of the first guidewire 1126 may be smaller than the diameter of the first guidewire 1126 and may be slightly smaller along the proximal section. The diameter may be at least about 0.030 inches, and in one implementation, about 0.038 inches. The transition section begins within a range of about 15 cm to about 30 cm from the distal end, typically at the distal about 20 cm or about 25 cm or less from the distal end, tapering in diameter distally from the distal end This is about 0.018 inches, and in one implementation it is less than about 0.016 inches. Referring to FIG. 2D, if an insertion catheter 1224 is utilized, it may be removed. , because it is too stiff to be advanced into the MCA 1204. In certain implementations, the transition guidewire 1226 provides sufficient back-up support. The combination access and suction catheter 1224 can be used without any intervening device. The transition guidewire can then be advanced directly over the transition guidewire. 226 is advanced to the MCA 1204. The transition guidewire 1226 is The distal section has a diameter smaller than the diameter of the first guidewire 1126. The distal section of the guidewire 1226 includes a soft, atraumatic tip and is connected to the ICA1. 206 toward the petrous division 1212 and the distal remote neurovascular system, e.g., the MCA 1204 can be made to follow.

[0089] Referring to FIG. 12E, the transitional guide sheath 1222 is inserted into the cancellous section 1 of the ICA 1206. 210 or cerebral division 1208 or beyond. Unlike the guide sheath 1122 of the previous embodiment, the transitional guide sheath 1222 is a cone section 1212 and advancing beyond the cavernous division 1210 of the ICA 1206 or the cerebral division 1208. 30, for example, as described further below. As will be described in detail below, it has a soft, yet compliant, distal section. The larger proximal diameter and stiffer body of the Dwyer 1226 allows for a transitional guide sheath. 1222 may provide better support for tracking through the vasculature.

[0090] Referring to FIG. 12F, the transitional guide sheath 1222 is inserted into the cerebral division 120 of the ICA 1206. After the transition guide wire 1226 is advanced to the distal end of the graft, the transition guide wire 1226 is removed. Vacuum pressure is applied to the proximal end of the transition guide sheath 1222 to draw blood through the central lumen of the transition guide sheath 1222. The inner diameter of the transitional guide sheath 1222 is approximately 0.100 inches. , about 0.088 inches, about 0.080 inches, about 0.070 inches, or about 0.060 The inner diameter of the transition guide sheath 1222 may be 1.5 inches or more. It is larger than the suction catheter 1128, which translates into more effective suction. The cross-sectional area of ​​the central lumen of the guide sheath 1222 is approximately 100 mm larger than that of the largest aspiration catheters currently available. It may be approximately twice as large as the cross-sectional area of ​​28.

[0091] A guide sheath 1222 is inserted into the distal vasculature to reach the clot or other desired target site. If the device is unable to track deep enough into the The extension section is introduced into the proximal end of the sheath 1222 and extends beyond the distal end of the sheath 1222. The catheter may be advanced distally to extend beyond the distal end of the catheter, thereby extending the reach of the aspiration system. In one implementation of the present invention, the extension section has an ID of about 0.070 inches.

[0092] Drawing thrombotic material into the sheath 1222 or extension section under constant vacuum If this is not possible, a pulsed vacuum may be applied as described below. If the sheath 1222 does not adequately capture the clot, the agitator is removed through the sheath 1222 and the extension section. The agitator may be advanced to help draw the clot into the central lumen. Further details are disclosed below.

[0093] To improve the efficacy of aspiration for vascular thrombectomy and to navigate through tortuous vasculature A pulsed vacuum aspirator may be used to improve the trackability of the catheter. FIG. 13 illustrates a pulsed vacuum aspirator 30 that applies an intermittent or pulsed vacuum to a lumen 40. 3 shows one embodiment of the pulsating vacuum aspirator 300. In the illustrated embodiment, the pulsating vacuum aspirator 300 is The vacuum chamber 31 is connected to the proximal end 12 of the hose 10 and includes a vacuum generator 302 and a vacuum chamber 31. 0, a collection canister 312, a solenoid valve 314, a frequency modulator 316, The console 300 includes a control panel 318 and a remote controller 320.

[0094] The vacuum generator 302 includes a vacuum pump 304, a vacuum gauge 306, and a pressure regulator control device 307. 08. The vacuum pump 304 generates the vacuum. The vacuum gauge 306 is 304 and indicates the vacuum pressure generated by the vacuum pump 304. The pressure regulation control 308 allows the user to set a specific vacuum pressure. Switches, buttons, levers, rotatable knobs, and the like that are readily accessible to those of skill in the art in light of the disclosure herein. Any of a variety of control devices may be utilized, including others that will be apparent to those skilled in the art.

[0095] The vacuum chamber 310 is in fluid communication with the vacuum generator 302 and contains a pressure reservoir and The collection canister 312 is in fluid communication with the vacuum chamber 310. The collection canister 312 is a collection canister for collecting debris or tissue. The remains or tissue may be used for pathological diagnosis. The vacuum chamber 310 and the collection canister 312 are separate and fluidly connected to each other. or may be combined components. In one embodiment, the vacuum chamber 310 and the collection canister 312 are a combined component. It is in fluid communication with a vacuum generator 302 .

[0096] The solenoid valve 314 is adapted to releasably connect with the access port of the catheter 10. and a luer or other connector configured to connect the vacuum chamber 310 / collection canister 312. The solenoid valve 314 is disposed in a fluid-connected path between the catheter and the The pump controls the flow of fluid from the heater 10 to the vacuum chamber 310 / collection canister 312 .

[0097] The pulsed vacuum aspirator 300 uses a frequency modulation to control the solenoid valve 314. The frequency modulator 316 may include a frequency modulator 316 that modulates different frequencies and These frequencies and shapes are controlled by the valve controller 318. The waveform generated by the frequency modulator 316 is a sine wave. Waveforms generated by the frequency modulator 316 include a square wave, a square wave, and a sawtooth wave. Frequencies below 500Hz, with some operating modes below approximately 20Hz or below approximately 5Hz The waveform goes from 0% where the solenoid valve 314 is fully closed to The duty cycle ranges from 100% with the lubricant 314 fully open.

[0098] The valve controller 318 controls the on / off state of the solenoid valve 314. The controller 318 is electrically or mechanically connected to the solenoid valve 314. Electrical controllers, switches, buttons, levers, rotatable knobs, and Any of a variety of control devices, including others that will be apparent to those of skill in the art in view of the disclosure herein. The valve controller 318 may be mechanically controlled by a user. The frequency modulator 316 may be electrically controlled. 16 and the valve controller 318 are separate components that are electrically or mechanically connected. It may be a single component or a combined component.

[0099] The remote controller 320 allows the doctor to operate the catheter 10 at the patient's side. For various purposes, e.g. turning valves on / off, selecting different waveform frequencies To select different waveforms, the frequency modulator 316 and / or the valve controller may be The remote controller 320 can control the inhaler 300 and the suction device 318. The communication may be wired or wireless.

[0100] By adjusting the frequency, duty cycle, and waveform, one skilled in the art can tune the resonant frequency. It is possible to match or approximate the natural frequency of the catheter. This allows the suction The catheter's natural frequency is typically around 260 It is less than Hz.

[0101] In another embodiment shown in FIG. 14, the solenoid valve 414 is at atmospheric pressure. The air / fluid reservoir 422 and the catheter 10 are connected to the vacuum chamber 410 / collection canister 4 12. The suction line 424 of FIG. Unlike the first embodiment, this system allows the pressure to vary from vacuum to atmospheric pressure. The pressure in the catheter 10 is adjusted by adjusting the solenoid valve 414. When open to the air / fluid reservoir 422 at atmospheric pressure, the true pressure in the suction line 424 The air pressure drops to atmospheric pressure. Also, when the solenoid valve 414 is closed, the suction The vacuum pressure in line 424 increases.

[0102] In yet another embodiment shown in FIG. 15, an electromagnetically actuated diaphragm 522 The terminating electrode 10 is attached to the suction line 524 connecting the vacuum chamber 510 / collection canister 512. The electromagnetically actuated diaphragm 522 is similar to that of a speaker driver. 5, which generates acoustic pressure waves within catheter 10. Diaphragm 522 is typically It has a structure similar to that of a speaker driver, and includes a frame 526, a cone 528, and a dust collector. A cap 530, a surround 532, a spider or damper 534, and a voice coil 5 36 and magnet 538. The strength of the acoustic pressure wave is modulated by the strength of magnet 538. A frequency modulator 516 connected to a remote controller 520 may 522 to generate different frequencies and forms of electrical waves, which The diaphragm 522 induces acoustic pressure waves in the suction line 524 and the catheter 10. is converted to

[0103] The tortuous vascular structure makes it difficult to track the catheter to the lesion site. It is a common reason for failure to treat blockages in the body's vascular system. It is difficult to navigate a catheter through critical structures, such as the neurovasculature. The catheter must be very soft so as not to damage the blood vessel wall. The tell must be able to navigate multiple tight turns without kinking. In addition, the catheter requires a large amount of force to be transmitted axially for advancement through the vasculature. All of these performance characteristics must be able to compete. It is a design requirement that optimizes one performance characteristic without sacrificing others. It is difficult to do so.

[0104] By reducing friction between the inner diameter of the blood vessel and the outer diameter of the catheter, the catheter can navigate through tortuous vascular systems. This minimizes the axial force required to advance the catheter through the catheter. Therefore, the column strength of a catheter must be traded off to optimize other catheter performance requirements. The catheter may be used to reduce friction between the inside diameter of the blood vessel and the outside diameter of the catheter. One method is to apply a thin layer of coating, usually hydrophilic in nature, to the outer diameter of the catheter. , reducing the surface friction coefficient of the catheter while in vivo.

[0105] In addition to or as an alternative to the water hammer structure described above, an axial Mechanical vibrations or shock waves are transmitted or induced at the distal end of the catheter using a variety of vibration generators. The vibration generator may be, for example, a spark gap generator, a piezoelectric pulse generators, electric solenoids, or rotating devices having one or more bends or supporting an eccentric weight. a wire or various other well understood techniques, for example in lithotripsy. A mechanical generator of shock waves or pulses is either a proximal It may be incorporated into the manifold 18 or may be attached to the manifold or proximal catheter as desired. Preferably, the control is on the manifold, and is provided on a proximal control device coupled to the manifold to control the strength and duration of the mechanical pulse. The shock waves support transluminal advancement and allow the clinician to vary the interstitial parameters. along the proximal section 33 to assist in the insertion of the catheter and / or extend the catheter depending on the desired clinical performance. It may be propagated along the distal section 34 via the wire 42 .

[0106] In the embodiment shown in FIGS. 16 and 17, the distal end 608 of the vibration device 600 is The catheter 10 includes a proximal end 12 (not shown) and a lateral end 30 of the catheter 10. The catheter 10 is induced to vibrate in a transverse direction and / or a longitudinal direction. This reduces the effective contact surface area between the blood vessel and the catheter 10, which This, in turn, reduces the surface friction between the inner diameter of the blood vessel and the outer diameter of the catheter. The device 600 induces longitudinal vibration in the catheter 10 to measure the inner diameter and cavitation of the blood vessel. This breaks static friction between the outer diameter of the catheter 10 and the outer diameter of the catheter 10, which reduces the overall surface friction. By reducing friction between the inner diameter of the vessel and the outer diameter of the catheter 10, the vibration device 60 0 improves catheter trackability through tortuous vasculature.

[0107] In the illustrated embodiment, the proximal end 602 of the vibration device 600 is connected to a vacuum pressure source, such as a vacuum generator. The proximal connector 604 is attached to the housing 606. In at least one embodiment, the proximal connector 604 may be a Luer connector. The distal end 608 of the device 600 is connected to the catheter 10. The distal connector 610 6, and is held in place by a flexible seal 612 attached to the housing 606. In at least one embodiment, the distal connector 610 may be a luer connector. The flexible seal 612 allows the distal connector 610 to move longitudinally as well as laterally. The flexible tube connects the proximal connector 604 and the distal connector 610. The slits 612 and 613 are slits 614 formed to allow fluid to pass therethrough.

[0108] The vibration device has a controller to turn the vibration on and off as well as to change its frequency. In this embodiment, the controller 616 is a slide switch. Electrical controls, switches, buttons, levers, rotatable knobs, and and others that will be apparent to those of skill in the art in light of the disclosure herein. Any of the above control devices may be used.

[0109] A vibration generating device such as a motor 618 is mounted eccentrically on the shaft that generates the vibration. Various motors, including motors, electromagnetic actuators, and piezoelectric transducers, are used. The frequency of the vibration is related to the RPM of the motor 618. A drive circuit 620 is connected to the motor 618 and the controller 616. Based on the operation of the 16, the motor 618 is driven at different RPM. The drive circuit 620 drives the motor 618 at different RPMs based on the position of the slide switch. A battery 622 is connected to the drive circuit 620 and the motor 618 to provide power. Supply.

[0110] A motor 618 is arranged perpendicular to the length of the suction channel 614 to produce longitudinal vibration. Alternatively, to create even greater longitudinal reciprocating motion, a mechanical A cam may be attached to the motor 618. The frequency range generated by the electric motor is , typically less than about 85 Hz. To achieve this, the electric motor may be replaced by an electromagnetic actuator. A piezoelectric transducer is employed to achieve ultrasonic frequencies in the range of about 1.6 MHz. This is also fine.

[0111] As shown in FIG. 18, in yet another embodiment, a stylet 702 A stirring body such as a stirring rod is inserted permanently or removably into the lumen 40 of the catheter 10, The catheter 10 is rotated to generate vibrations, which allow the catheter to pass through a tortuous vascular system. The stylet 702 has an outer diameter of about 0.005 inches (about .127mm) to approximately 0.035 inches (approximately 0.889mm) , may have at least one bend or at least one weight. The transverse distance between the apex and the tip of the catheter 10 when positioned within the catheter The bend or weight of the stylet 702 extends along the entire length of the catheter 10. may be positioned at different locations along the length of the catheter depending on the desired performance. Contained within the most distal 50%, 30%, or 10% of the vibration zone The purpose is to provide a catheter 10 with a suitable catheter-like structure, which is most desirable when tracking the catheter 10 through the distal vasculature. The aim is to create new vibrations.

[0112] Alternatively, the stylet 702 may have a distal vibration zone or a distal end that is provided with beads or the like. The stylet 702 may be made of monofilament or braided. It may include wrapped or woven filaments or wires.

[0113] In another alternative, the stylet 702 may include a heater (e.g., an electrical coil) at its distal end. which promotes dissolution of the clot or is aspirated into the catheter. It changes the size of the thrombus.

[0114] The proximal end of the stylet generates rotational and axial reciprocating motions at various frequencies. The motor drive 704 is attached to the motor drive-stylet The assembly 700 is formed. The assembly 700 can be used not only to turn on and off the rotational motion, but also to In this embodiment, the controller 706 is The controller 706 is depicted as an on / off button. switches, buttons, levers, rotatable knobs, and any other components that will be apparent to those of ordinary skill in the art in light of the disclosure herein. Any of a variety of control devices may be utilized, including others that may be readily apparent. 0 proximal luer 708 or other connector connects catheter 10 to motor drive 804 Can be installed in both directions.

[0115] Once the catheter 10 reaches its intended location, the motor drive-stylet assembly The entire frame 700 may be disconnected and removed from the catheter 10, thereby removing the central suction A catheter lumen is left behind.

[0116] In patients with vertebral artery occlusion, treatment with angioplasty may be effective in preventing the occlusion of the basilar artery downstream of the occlusion. This may cause complications due to embolization of the cerebrovascular disease. Emboli small enough to enter the vein are usually trapped at the top of the basilar artery where it branches into the posterior cerebral artery. The resulting reduction in blood flow to the ascending reticular formation of the midbrain and thalamus has immediate consequences. The devices described herein may be delivered to the vertebral artery or further distally, e.g. For example, it can be used to remove thromboembolic material in M1, M2, or M3 arteries. can.

[0117] To provide vibration aids for navigation and / or for debris acquisition and The agitator for assisting the aspiration is further described in relation to Figs. 19-24. As seen in FIG. 1, the agitator 1900 has a proximal control device end and a distal active zone or end. The device may include an elongated flexible body such as a wire or hypotube having a The tube stirrer has a longitudinally extending inner lumen that allows for the injection of media. 19, an agitator 1900 includes a wire or hypotube 1904, This is introduced into the proximal end of the catheter 1902 and into the distal end 1907 of the catheter 1902. The distal tip 1905 of the agitator 1900 is advanced to the distal end of the catheter 1902. The agitator 1900 may be disposed at, beyond, or within the catheter. The catheter 1902 is preloaded into the catheter 1902 and inserted into the patient's body together with the catheter. or added after the catheter 1902 is placed. When loaded into the catheter 1902, the agitator 1900 extends along the length of the catheter 1902. The agitator 1900 may extend substantially longitudinally along the length of the agitator 1900. It may further include a controller at the proximal end for axial adjustment. The controller of the 00 controls the agitation of the variable length catheter, such as that discussed in connection with FIG. 1900, is used to axially adjust the position of the distal tip 1905. Good too.

[0118] In one implementation of the invention, the stirrer and the drive are configured as stand-alone devices. Once the distal section 34 (FIG. 3B) is within a few centimeters (e.g., about 3 or 2 centimeters) of the obstruction, When the stirrer 1900 is positioned within the range of the pull wire 42, the distal end of the stirrer 1900 is The agitator 1900 may then be advanced distally to introduce the agitator into the proximal end of the central lumen 45. A distal section of the stirrer 1900 extends beyond the distal end of the puller wire 42 into the distal section 34. The stirring body 1900 included within the range of the lumen 45 of the pull wire 42 may be The section is restrained from any significant lateral movement. However, the puller wire The distal portion of the agitator 1900 that extends beyond the distal end of 42 is relatively laterally constrained. 3, but rather agitates the thrombus to facilitate drawing the thrombus into and through the distal section 34. Once the clots have formed, they can be stirred under vacuum and, if necessary, by the action of the stirrer. When the suction reaches the increased ID at the proximal end of the distal section 34, the suction becomes clogged. The risk of injury is significantly reduced.

[0119] The agitator 1900 can be manually or motor driven from the proximal end of the catheter 1902. 1906 to rotate or translate the distal end of the agitator 1900. The driver 1906 may be permanently or removably attached to the proximal end of the agitator 1900. The driver 1906 may be connected to a guidewire torquer. The drive may be a manually controlled manual drive such as a manual torquer. The motorized drive 1906 may be a motorized drive that can be rotated in a direction (CCW / It may be manually controlled with respect to one or more factors such as CW, speed, duration, etc. The actuators may be driven with respect to one or more factors such as direction (CCW / CW), speed, duration, etc. In one embodiment, the rotation direction of the stirring body is reversed periodically. .

[0120] The automatically controlled drive device may include an actuator, and the operation of the actuator may be The actuator can execute a series of pre-programmed steps. buttons, dials, knobs, switches, levers, valves, slides, keypads, or or any combination thereof. The drive unit 1906 may also be a synchronously controlled In this case, the drive unit 1906 may perform stirring and agitation in synchronization with the aspiration and injection of the medium. The agitator 1900 drives the agitator 1900 at its distal end to promote clot engagement and The device may be configured to assist with movement and mobility.

[0121] Injecting a medium into / around the area of ​​the clot can help dislodge the clot from the vasculature. It is possible.

[0122] The agitator 1900 includes a distal end 1912, a proximal end 1914, and a distal tip 1905. The proximal end 1914 of the agitator 1900 is adapted to allow the agitator 1900 to move within the curved vasculature. The torque required to rotate the distal end 1912 of the catheter 1902 when placed therein. The agitator 1900 has a cross section and / or wall thickness large enough to transmit the torque. The outer diameter is about 0.25 mm to about 0.65 mm, about 0.3 mm to about 0.6 mm, about 0.3 5mm to about 0.55mm, about 0.4mm to about 0.5mm, about 0.42mm to about 0. 48 mm, or from about 0.44 mm to about 0.46 mm. For 904, the wall thickness of the hypotube 1904 ranges from about 0.01 mm to about 0.29 mm; Approximately 0.05mm to approximately 0.25mm, approximately 0.1mm to approximately 0.2mm, approximately 0.12mm from about 0.18 mm, from about 0.13 mm to about 0.17 mm, or from about 0.14 mm to about 0 It may also be .16mm.

[0123] The agitator 1900 may further include a guide tube 1910, such as a hypotube. , rotate the agitator while restraining the proximal drive section of the agitator 1900 from lateral movement. or reciprocating in the axial or rotational direction. The distal end 1911 of the guide tube 1910 may be adjusted to accommodate the agitator 190 depending on the desired performance. Within about 25 cm, or within about 20 cm, or within about 15 cm of the distal end of The guide tube 1910 may be positioned within the distal end 1911 of the guide tube 1910. The distal section of the agitator 1900 is laterally unconstrained within the ID of the distal section 34 and the material to agitate materials and facilitate the aspiration of materials into and through the central lumen It can be used to

[0124] The diameter of the stirring body 1900 may be constant along its longitudinal length. The diameter of 900 is adjusted along its longitudinal length to match the characteristics of the catheter 1902. In one implementation, the diameter of the agitator 1900 may increase or decrease along its longitudinal length. Reduced distally by at least one step or tapered zone to increase flexibility This is what they are doing.

[0125] The distal end 1912 of the agitator 1900 may be straight. The distal end 1912 of the catheter may be curved or shaped in various ways to interact with the clot. FIG. 19 shows a motion segment having a length of about 1 mm to about 15 mm. 20A illustrates a curved portion 1917 spaced from the distal tip 1905 by 1909. 20C illustrates a more complex exemplary shape of the moving section 1909 of the stirring body 1900. 20D-20E show a swellable polymer having a distal funnel-shaped structure positioned within the distal funnel-shaped structure tip. The stirring body is illustrated.

[0126] The stirring body 1900 may comprise a single homogenous material or multiple materials. The material of the body 1900 may be engineered (e.g., processed) to impart various properties suited to local performance requirements. The stirring body 1900 exhibits high torque transmission properties while The agitator 1900 may be constructed to provide flexibility. Stainless steel, 316LVM stainless steel, PTFE, Parylene, At least one of the surfaces of the stirring body 1900 may be made of any combination thereof. The entire length of the stirring member 1900 may be coated. The coating on the agitator 1900 provides lubrication between the ID wall of the catheter 1902 and the agitator 1900. An intermediate hypotube may be provided between the wall of the catheter 1902 and the agitator 1900. In the case where a tube, such as a restraining tube 1910 or a tubular pull wire 42 is disposed In this case, the coating on the agitator 1900 is between the intermediate hypotube and the proximal drive of the agitator 1900. The coating material of the wire or hypotube 1904 may provide lubrication between the wire and the hypotube. Includes PTFE, Parylene, Teflon, or any combination thereof.

[0127] of any catheter shaft or other catheter component disclosed herein, Any ID or OD may have a lubricating coating or may have a lubricating coating. They may be made from a variety of materials, such as polyacrylamide, PEO, thermoplastic starch, etc. Hydrophilic polymers such as propylene, PVP, and copolymers of hydrophilic polymers are used in the Tecoflex (T Hydrophobic polymers such as PEO soft segmented polyurethanes blended with ecoflex The lubricating coating or material may be extruded with the polymer during melt processing. The lubricant coating or material may comprise at least one surface modification additive (SMA). Ease of navigation, lower ID surface friction, or better clot removal. In some embodiments, after treatment of the wire for exposure to moisture, temperature, etc. , electron beam, gamma radiation, UV, etc. may be more desirable. The catheter is Aims for both OD and ID lubricity and inherent thrombophilic properties without the need for a coating process Hydrothane, Tecophilic ic) may be made from PEO impregnated polyurethanes such as polyurethane.

[0128] Referring to FIG. 20A, the distal end 2012 of the agitator 1900 includes a coil 2020. The coil may be configured to grip the embolized clot and rotate the catheter 2006. The coil 2020 is for agitating the distal end 2010 of the catheter 2002 and the blood clot. The coil may be wound around the center of the wire and may be off-centered, with at least one complete turn. , and may optionally include two, three or more complete revolutions.

[0129] Referring to FIG. 20B, the distal end 2012 of the agitator 1900 grasps and emulsifies the clot. The hook 2022 may include a hook 2022 for receiving the needle. The hook 2022 may be proximally concave. 20C, or may extend transversely to the axis of the stirrer and circumferentially. By way of reference, the distal end 2012 of the agitator 1900 is fitted with a loosely wound coil or spring 2024. The loosely wound coil or spring 2024 may include a It may expand (get longer) and contract (get shorter).

[0130] 20D-20E, the distal end 2012 of the stirring body 2000 includes a coil 2026 The coil may include a coil that grips the embolized clot and causes the catheter 2 to rotate. 20. The catheter 2002 is provided with a distal end 2010 for agitating the distal end 2010 of the catheter 2002 and the blood clot. The distal end 2010 of the catheter 2002 may include a polymeric sidewall that deforms upon hydration. The polymer maintains the lumen of the guidewire during catheter placement. The distal end 2010 of the catheter 2002 expands into a funnel shape after absorbing serum from the blood. See FIG. 20E.

[0131] 21A-21B, the distal tip 2110 of the catheter 2102 includes an agitator 1900. The distal end of the stirring body 1900 may move or swing. When the stirring member rotates (e.g., via a drive 2106), the moving section 1909 of the stirring member and The distal tip 1905 is connected to the oscillating catheter 2102 as shown by the dashed line 2112. The length of the moving section, the stiffness of the agitator 1900, and the rotation speed determine the The catheter 2102 is then moved along with the side wall of the catheter 2102 and the agitator 1900 as it rotates. The amount of oscillation transmitted to the coil 2101 is determined.

[0132] Alternatively, the distal tip 2110 of the catheter 2102 may be attached to the distal end of the hypotube 2124. A pulsed medium jet existing in one or more holes near the end of the The hypotube 2124 may be moved or swung by a jet. The tube 2124 has an inner lumen extending along the longitudinal length thereof. 2128 may be disposed near the distal end of the hypotube 2124. The lumen of the hypotube 2124 and the outside of the hypotube 2124 (i.e., the lumen of the catheter 2102) A medium (e.g., saline) is pumped under pressure through the hypotube. From the proximal end of the tube 2124, through the lumen of the hypotube 2124, The medium may be introduced through one or more holes in the tube 2124. When injected into the hypotube 2124, a pulsed jet of media 124 and transmits a force to the wall of the catheter 2102, resulting in the catheter 21 The hypotube 2124 causes the catheter 2102 to swing. For ease, it may further be rotated (eg, via drive 2106).

[0133] 22A-22B, the hypotube 2204 includes one or more holes 22 10 and flexed near a distal portion thereof to provide a motion section 1909. The medium (e.g. saline, drug, lubricant such as polyethylene glycol) , injected from the proximal end 2200, through the inner lumen, and into the hypotube 2204. The vacuum exits through the hole 2210 (direction of media release shown as 2208). 202 at its proximal end 2200, which is connected to the central lumen of the hypotube 2204. Media discharged from the holes 2210 flows along the central lumen of the catheter 2202 to its proximal end 2206. This is done by pulling it proximally towards 200.

[0134] As the hypotube 2204 rotates, it expels the media. At the same time, the distal tip of the catheter 2202 is rocked. When the distal tip of the catheter 2202 swings due to rotation, the swinging of the catheter 2202 may push the clot 2214 to the left or right, and the hypotube 2204 may simultaneously push the clot 22 14 and catheter 2202, releasing the medium to the interface between the blood clot 2214. This provides a lubricious passageway for fluid to flow into the catheter 2202.

[0135] Rotation of the motion segment 1909, with or without injection of a medium, breaks up or reshapes the clot. This helps facilitate entry into the aspiration lumen. In certain circumstances, blood clots may form within the central lumen. In other circumstances, the clot may be partially aspirated, as shown in FIG. In some cases, the catheter can only be pulled into the central lumen by force. To hold the clot at the distal end of the catheter, the agitator rotation was stopped while the vacuum was still applied. The catheter is then removed proximally, pulling the clot out into the access sheath along with it. It may exit through a proximal vascular access point.

[0136] 23A-23B, the hypotube 2304 extends from the distal end more proximally to the distal end. It may have one or more holes along its surface, allowing the catheter 23 02 tends to migrate or flow to the proximal end 2300 of the catheter. A vacuum 2316 is applied to the proximal end 2300 of the catheter 2302 to remove the removed blood. The rice cake 2314 is moved from the distal end toward the proximal end 2300 of the catheter 2302. As shown in FIG. 3A, the holes provide a membrane 2312 around the inside of the wall of the catheter 2302. This facilitates the flow of media and / or blood clot 2314 and reduces the amount of blood clot 2314. As shown in FIG. 23B, the hypotube 2304 may include one or more 2304, which allows the fluid to be radially discharged from the hypotube 2304. A media jet is provided to cause the blood clot 2314 to form a single or multiple layers on the surface of the hypotube 2304. or multiple holes to grasp, draw out, and / or emulsify the clot 2314. To make.

[0137] Referring to FIG. 23C, a vacuum port 2416 may be provided on the catheter 24, such as on a manifold. 02 proximal end 2400, which may be provided for aspirating blood clots from the vasculature. This allows the vacuum port 2416 to be 24, which may be separated from the proximal port 2417 for receiving the agitator 1900. Thus, movement or control of the wire or hypotube 2404 at its proximal end is essentially Minimize risk of adverse effects from empties, aspirated clots, and / or media The vacuum port can be connected to the catheter 2400 via a rotating hemostatic valve, discussed below. May be connected.

[0138] 24A-24H, a distal tip having enhanced axial position control is provided. 2 shows an embolic therapy system 2401 in accordance with the present invention having

[0139] Referring to FIGS. 24A and 24B, the suction catheter or tubular Any of the extension sections may include a distal axial restraint device, which may be located on the stirrer. In cooperation with a complementary stopper, the agitator is permitted to rotate but the agitator's distal axial range of movement is limited. This limits the amount of bending of the catheter shaft. Accurate positioning of the distal agitator tip relative to the distal end of the catheter and The distal tip is prevented from extending beyond a preset location, such as the distal end of the catheter. It is possible.

[0140] In the illustrated implementation, the distal restraint device or component extends radially from the inner surface of the tubular body. The aspiration lumen includes at least one inwardly extending protrusion that limits the inner diameter of the aspiration lumen. and providing an interference surface for engaging a distal surface supported by the agitator. The restraint device may be configured with one, two, three or four tabs. may include four or more lobes, or may be continuous, as illustrated. The axial restraint may include an annular ring providing an annular, proximally facing restraint surface. The proximal bearing surface of the device is about 50 cm, or about 30 cm, or about 15 cm from the distal end of the tubular body. The distal rotatable tip 450 and the distal port of the catheter may be located within a range of 1 cm. To optimize the alignment with the port and its axial alignment, For example, tortuous vessel pathways that change the relative axial position of the catheter exit port and tip. To separate the row, the proximal bearing surface of the axial restraint device should be in the range of about 3 mm to about 50 mm. In some implementations, the range is about 5 mm to about 20 mm, and in one implementation, the distal end of the catheter. The location of the port is often within about 6 mm to about 14 mm of the port.

[0141] The distal restraint device is attached to the side wall 2403 of the catheter near the distal tip and has a metal (e.g., nitinol, stainless steel, aluminum, etc.) embedded therein. The distal restraining component 24 may be a circular band or ring or protrusion 2402. 02 extends into the ID of the catheter. Additionally, the distal restraining component 2402 is fluoroscopically The distal restraining component 2402 may be radiopaque for visibility under 2405 supports a proximally facing surface 2405 that extends within the inner diameter of the catheter, for example. 2414 on the rotating assembly. For example, the distal stop 2414 may be an annular feature on the rotating assembly, The function is to contact the distal restraining component 2402 of the catheter and stop distal advancement, thereby retracting the catheter. This prevents displacement of the distal tip beyond the distal tip of the catheter.

[0142] In one implementation, the ring 2402 may be in its relaxed configuration prior to being secured within the catheter lumen. In the present case, the casing is C-shaped or cylindrical with a slit extending axially to form a split ring. The ring 2402 is compressed using a fixation device that contracts the ring into a closed circular shape. This allows the ring to slide within the (e.g., 0.071 inch) catheter. Once the ring is released from the fixation device, it can be moved to the catheter as allowed by the inner diameter of the catheter. The ring expands radially to its maximum diameter. The radial force of the ring acts on the inner surface of the catheter. and resists axial displacement under the applied forces of intended use. So, the ring is a completely closed continuous annular structure (like a typical marker belt). The distal end of the ring is slightly flared radially outward to form a locking edge. The gag is inserted into the catheter from the distal end. When an axial force is applied from the proximal side, A flared section with locking edges holds the ring in place.

[0143] 24C and 24D, the distal section 2407 of the rotatable core wire The torque coil 2412 surrounds the eye wire 2410. 2413 concentrically surrounds an inner coil 2415 having windings in the opposite direction. Although the coil 2412 is shown as having a constant diameter, it may be tapered. As a result of the core wire being pulled out of the coil, there is a trapped space between the coil and the core wire. The area of ​​the aspiration lumen between the coil and the corresponding inner wall of the catheter is optimally maximized. The diameter of the coil 2412 tapers distally to follow the taper of the core wire. This is done by attaching the coil to a core wire that acts as a tapered mandrel. This can be accomplished by rolling or using other techniques known in the art. When this is done, the OD of the core wire tapers distally. Meanwhile, the area of ​​the aspiration lumen tapers distally.

[0144] As further illustrated in FIGS. 24E and 24F, the torque coil 2412 has a proximal end 4 30 and a distal end 432. The proximal end 430 is tapered to the distal end of the core wire 2410. As illustrated in FIG. 24E, the core wire 2410 is secured to the proximal zone. The distal zone 434 tapers from a larger diameter in the distal region 435 to a smaller diameter in the distal zone 434. a tapered portion and a distal zone which may have a substantially constant diameter therethrough. The inner diameter of the inner coil 2415 is 434, with a distal transition 436 between the inner coil 2415 and the core wire 434. The outer diameter of the core wire 2410 at the proximal end 430 is complementary (approximately the same). The tapered portion of the core wire 2410 extends from the distal transition 436 until the core wire 2410 reaches a constant diameter. The proximal transition portion extends proximally to a proximal transition portion (not shown) having a

[0145] The torque coil 2412 may additionally include proximal radiopaque markers and / or connectors. In the illustrated implementation, the proximal connector may include a connector such as a solder joint 438. 438 is an annular silver solder band that surrounds the inner coil 415 and the outer coil 2413 abuts against its proximal end.

[0146] The axial length of the torque coil 2412 is within a range of about 10 mm to about 50 mm. In some embodiments, the distance is within a range of about 20 mm to about 40 mm. and distal stop 2414 may range from about 5 mm to about 20 mm, and in some implementations 24, the distal cap 2420 is positioned within a range of about 8 mm to about 12 mm from the proximal end of the distal cap 2420. This may also be the case.

[0147] Referring to FIG. 24E, a distal stopper 2414 is disposed radially outward from the outer coil 413. having one, two, three or more spokes 440 extending along the Optionally, the torque coil 2412 may be supported by an annular hub 442. The spokes 440 may be configured to slidably fit within the inner diameter of the delivery catheter lumen. The slider 441 has a peripheral surface 442. 3, 4, 5 or more spokes 440 provide balance in rotation. In the illustrated embodiment, three spokes 44 are provided at equal distances apart. The torque coil 2412 has zeros spaced approximately at 120° intervals around its circumference.

[0148] The distal stop 2414 supports, for example, a plurality of distal surfaces 446 on the slider 441. The surface 446 may extend radially inwardly, e.g., toward the proximal surface of a stop device on the inner diameter of the delivery catheter. 2402. The proximal facing surface 2405 on the annular flange or ring 2402 slideably engages the proximal facing surface 2405 on the annular flange or ring 2402. See FIG. 24B discussed above. This provides a bearing surface and An interference fit is created to allow the distal stopper 2414 to rotate within the delivery catheter. and a distal surface 446 slidably engages a proximal surface 2405 on the stop ring 2402. The distal end can move axially in the distal direction to the same extent as or just before the distal end is engaged with the distal end.

[0149] Referring to FIG. 24E, the distal end 432 of the torque coil 2412 is secured to the distal cap 242. 0. The distal cap 2420 includes an annular band, e.g., a radiopaque marker band. The band may be attached to the outer surface of the inner coil 2415 and to the outer coil 2416. 413. A proximally extending appendage, such as 7, may be provided on the agitator tip 2416, which 24 for coupling to the position cap 2420 and, in the illustrated embodiment, to the outer coil 2413. The distal cap 2420 also secures the distal end of the core wire 2410 to the may be directly or indirectly bound to

[0150] The agitator tip 2416 has a distal end 450 and extends proximally and increases in diameter in the proximal direction. The flange includes a helical flange 452 that extends along the length of the core wire 2410. At least nearly one complete revolution around the extension of the directional axis, and generally about 5, or about 4 The helical flange may extend for 3 or fewer revolutions. and a rounded, blunt edge 454 configured to slidably rotate within the is.

[0151] The maximum OD of the tip 2416 is the maximum OD when the stopper 2414 is engaged with the stop ring. When measured at the axial operating location of end 2416, embolic therapy system 2401 is passed through Generally at least as far away as the ID of the catheter aspiration lumen that is intended to be advanced through the catheter. about .005 inches, preferably at least about 0.01 inches, or 0.015 inches; or smaller. For example, a maximum OD in the range of about 0.050 to about 0.056 inches. In one embodiment, the tip has a diameter in the range of about 0.068 to about 0.073 inches. would be positioned in a catheter having a distal ID of approximately 0.071 inches. With the tip in the center of the lumen of the delivery (aspiration) catheter, the tip From the inner wall of the tube, at least about 0.005 inches, and in one embodiment at least about 0. .007 inches, or approximately .010 inches, or more, away in all directions. It's been a while.

[0152] Thus, the annular space between the maximum OD of the tip and the ID of the catheter lumen is free of obstructions. This annular passage cooperates with the vacuum and the spiral tip to rotate and The catheter is then placed under vacuum to grasp and extract the obstructing material. Due to manufacturing tolerances in the tip that is configured to shear embolic material between the catheter wall This is significantly larger than any flow path that may result.

[0153] A helical flow passage in which an additional suction volume is defined between every two adjacent threads of the tip The maximum OD ranges from about 0.050 inches to about 0.056 inches. The cross-sectional area of ​​the spiral passage at the tip is generally at least about 0.0003 square inches. , in some embodiments at least about 0.00035 inches, or at least about 0. 000375 inches. Therefore, the total suction flow path across the spiral tip is and an annular flow path defined between the OD of the tip and the ID of the catheter lumen. This is the sum of the two.

[0154] A rounded edge 454 on the thread 452 and less than about 20 turns, or less than about 10 turns, or The threads 452 and the cartridge are attached to the tip by slow manual rotation of the tip through approximately 5 or less turns. By combining the space between the inner wall of the catheter and the adjacent helical threads, It is possible to draw both through the spiral channel and around the outside of the tip 2416. This suction acts only to allow the assembly to engage and capture embolic material. However, the catheter is configured so as not to shear embolic material between the sharp edge and the inner wall of the catheter. Once engaged, additional rotation can be used to move the aspiration catheter away from the clot. to anchor the proximal portion of the clot and facilitate proximal retraction and removal. The axial length of the tip 2416, including the attachment sleeve 2417, is generally about 6 mm. and preferably less than about 4 mm, or less than about 3 mm, or less than about 4 mm, or less than about 3 mm, depending on the desired performance. or less than about 2.5 mm.

[0155] The pitch of the threads 452 is generally within the range of about 35 degrees to about 80 degrees, depending on the desired performance. A thread pitch in the range of about 40 degrees to about 50 degrees provides optimal results for hard clots. While pitches between about 50 degrees and about 70 degrees may work well, pitches between about 50 degrees and about 70 degrees may not be suitable for soft clots. In some implementations, the pitch is between about 40 degrees and about 65 degrees. Within the range, or within the range of about 40 degrees to about 50 degrees.

[0156] The tip 2416 may additionally attract and / or enhance the adhesion of a blood clot to the tip. For example, the tip material may be treated or coated with a coating. By deposition, microporous, microparticulate, nanoporous, or nanoparticulate The tip may be textured, such as with a granular surface. A coating of an attractive compound may be applied to the surface of the tip. For example, a roughened polyurethane coating may be applied. Polyurathane (Tecothane, Tecoflex (Tecoflex) coating at least on the thread surface and optionally over the entire tip. The polyurethane is preferably roughened after coating, for example by solvent treatment. Alternatively, the tip surface may be roughened prior to coating to prevent coating of the tip. The adhesion of the film may be improved.

[0157] Alternatively, the core wire 2410 may be provided with an insulating coating, which may provide a negative charge. The propagation of the thrombus is delivered to the tip, allowing the thrombus to be attracted. For example, it may be in a coaxial configuration and extend the entire length of the body. and discussion in U.S. Pat. No. 10,028,782 to Orion; As disclosed in U.S. Patent Publication No. 2018 / 0116717 to Taff et al. No. 6,399,633, the disclosures of which are expressly incorporated herein by reference in their entireties. As a further alternative, tip 2416 can be cryogenically cooled to create a small gap between the tip and the thrombus. Small cryoadhesion can be produced. Small cryogenic tips for intravascular catheters can be fabricated. The study of how to achieve this is described in U.S. Pat. No. 015 / 0112195, and Ryba et al., 2018 / 0 No. 116,704, the disclosures of each of which are incorporated herein by reference in their entireties. Explicitly included.

[0158] Referring to FIG. 24G, a cross section through the distal stopper 2414 is shown. In the embodiment, the slide 441 is a continuous circumferential bearing surface 442. The wall is made up of three spaced apart struts 440 with three axially extending struts 440 extending therethrough. The sum of the surface areas of the leading edges of the struts 440 is equal to the surface area of ​​the open flow passage 443. As a percentage of the sum of the areas, the maximum area for suction is preferably minimized. At the same time, distal surface 446 (see FIG. 24F) contacts the inner wall of the catheter. for engaging a complementary stop surface and for moving beyond a preset relationship with the catheter. Sufficient support is also provided axially to prevent end 2416 from advancing distally. The sum of the (distal-facing) surface areas of the tips of the struts is generally less than about 45%, typically less than about 30%, or less than about 25%, or less than about 20% of the sum of the areas of the channels 443 .

[0159] In an embodiment having a torque coil 2412 with an OD of about 0.028 inches, The OD of the 2414 is approximately .068 inches. The wall thickness of the post is generally approximately .015 inches. The distance is less than about 0.010 inches, typically less than about 0.0 The length of the support 440 is less than about 0.08 inches, or less than about 0.005 inches. A catheter with sufficient axial length to support the assembly against distal migration beyond the ring. The length may be at least about 50% of the OD of the stopper 2414. In a stopper 2414 having an OD of 68 inches, the support 2440 is at least about 0. .75mm, or approximately 0.95mm axial length.

[0160] Referring to FIG. 24H, three different The stopper 2414 having the slider 441 is illustrated. The sum of the circumferential portions of the three peripheral surfaces The total is preferably about 75% or less, and in some implementations, as shown in FIG. 24G, The total length of the peripheral surface 442 of the continuous circumference is about 50%, or about 40% or less. , the cross-sectional area of ​​the flow passage 443 is further increased. Hub 44 with OD of .026, or approximately .028, or approximately .030, or larger In a catheter having 3, the total of the flow channels 443 is at least about 0.0015 inches. , preferably at least about 0.020, or about 0.022 inches, or more. The area of ​​the leading edge of post 440 and slider 441 is preferably about .003 inches or less. , more preferably about 0.001 inches, or 0.0008 inches, or less. In the axial direction of the catheter, the length of the struts 440 is at least about 0.50 mm, and is about 0.75 mm, and in one embodiment, the length of the post 440 and the slider 441 is about It is 1mm.

[0161] One method for using the above system is described below. Introduce the catheter, if possible, with the tip of the catheter slightly closer to the site of obstruction. The .071 suction catheter in Figures 24A and B is advanced into the .088 LDP. The catheter is then advanced through the endoscopic catheter until the tip of the catheter reaches the clot surface. 2. Remove any intermediate catheters or guidewires. 3. Replace the rotatable core wire with the Introduce the distal tip flush with the distal end of the .071 suction catheter. Proximal RH Seal the V and apply vacuum to the .071 suction catheter using the suction pump. Rotate the catheter by hand approximately 2 to 10 times, but generally no more than 20 times, to remove the blood clot. Engage the catheter without cutting it and pull the catheter partially distally across the clot. Stop rotating the Awire.

[0162] The aspiration catheter is now secured to the clot. Advance the .088 catheter over the aspiration catheter until the catheter reaches the surface of the clot. The suction catheter acts like a guidewire. Using a vacuum source such as a Lok) syringe, apply vacuum to the 088LDP guide catheter. The suction catheter with the clot attached to its tip is inserted into the occlusion site, and the 088LDP is positioned. While maintaining this position, retract proximally through the 088LDP guide.

[0163] If flow is not restored through the 088LDP, remove the core wire from the aspiration catheter. If necessary, wipe the spiral tip of the core wire to remove any residual clots. The core wire and aspiration catheter are then returned to the site of the occlusion and the clot retriever is used until flow is restored. The procedure may be repeated. Once flow is restored, remove the .088LDP guide catheter. .

[0164] 25A-25C, the experiment showed that the vacuum was interrupted and the vacuum and release cycles were After the catheter is inserted, the blood clot that has become stuck to the distal end 2512 of the catheter 2510 is loosened and the catheter is then inserted. Reshaping the catheter to fit the 2510 may aid in the aspiration of the clot. Simply turning off the vacuum is not sufficient to loosen the clot. The clot was then completely released (vented to atmospheric pressure) to relax, after which the vacuum was reapplied, resulting in embolization. It has been found that the blood clot is most efficiently aspirated at the time of each vacuum and release cycle. The limits are approximately 0.1 seconds, 0.5 seconds, 1 second, 2 seconds, 3 seconds, 4 seconds, 5 seconds, 6 seconds, 7 seconds, 8 seconds, and 9 seconds. , or may be 10 seconds or more.

[0165] 25A-25C illustrate a diagram of cycles of vacuum and release applied to catheter 2510. The release line 2518 and the vacuum line 2520 are connected to the catheter 251. 0 at or near its proximal end. Release line 2518 is and is in communication with atmospheric pressure to open and close the fluid communication between the catheter 2510 and the vacuum. The vacuum line 2520 has a relief valve 2514 configured at its proximal end. in communication with a vacuum and configured to open and close fluid communication between the catheter 2510 and the vacuum; The vacuum valve 2516 is connected to the vacuum source 2516.

[0166] As shown in FIG. 25A, in the first step, the relief valve 2514 is closed, The vacuum valve 2516 is opened and a vacuum is applied to the catheter 2510 to aspirate the clot. Then, as shown in FIG. 25B, with the vacuum valve 2516 still open, In this state, the relief valve 2514 is opened. The relief line 2518 and the vacuum line 2520 are directly Since the catheter 2510 is in fluid communication with the suction port 2520, the vacuum can It is applied primarily through the open line 2518 to reduce the vacuum applied to the catheter. Finally, as shown in FIG. 25C, the vacuum valve 2516 is shut off to completely release the vacuum and remove the blood. The rice cake is then released. After that, the release valve 2514 is closed and the vacuum valve 2516 is opened. This starts another cycle from FIG. 25A to FIG. 25C.

[0167] Referring to FIG. 26, a proximal portion of the stirrer 1900 is provided which provides an interface for driving the stirrer 1900. A drive assembly and / or a rotating hemostatic valve are illustrated, and a port for injecting a medium is provided. A suction port and a suction port are provided. See Figures 26, 27A, 27B, and 28. The proximal drive assembly 2602 and the rotary hemostatic valve 2620 are connected to the proximal end of the agitator 1900. The proximal portion of the agitator 1900 may be releasably or permanently coupled to the agitator 1900. 2602. The hemostatic valve 2620 is then passed proximally through the lumen of the proximal drive assembly 2602. The proximal end of the agitator 1900 terminates within the lumen of the proximal drive assembly 2602. The distal portion of the proximal drive assembly 2602 may be inserted into the proximal end of the rotating hemostatic valve 2620. In another embodiment, the proximal drive assembly 2602 is integral with the rotating hemostatic valve 2620. It may be embodied.

[0168] The rotating hemostatic valve (RHV) 2620 includes a distal connector 2630 at its distal end. The connector is configured to couple the rotating hemostatic valve to the proximal end of a catheter (not shown). The distal connector 2630 may be a luer connector. The rotating hemostatic valve 2620 is Includes a central lumen along its longitudinal length through which a proximal section of the agitator 1900 passes. The rotating hemostatic valve 2620 further includes a suction port 2622, which is A suction flow path is provided by branching off from the central lumen of the hemostasis valve 2620. The rotating hemostasis valve 2620 is The proximal rotating collar 2628 is disposed at the proximal end of the V-seal 2626. 628 controls the opening and closing of the RHV seal 2626. The user (e.g., a physician) The RHV seal 2626 can be opened or closed by rotating the collar 2628. When closed, the RHV seal 2626 is in contact with the inner lumen distal to the RHV seal 262. and the inner lumen proximal to the RHV seal 262. The portion 262 is a longitudinal extension of the distal portion of the proximal drive assembly 2602 within the rotating hemostatic valve 2629. Does not impede movement.

[0169] In the experiment, the wire or hypotube 1900 rotates back and forth (i.e., vibrates). ) and the distal end of the stirring body 1900 changes its position relative to the catheter. The distal end of the stirring body 1900 is rotated by the stirring body 1900 or the medium injection pressure is increased. The wire or hypotube 2624 may become coiled or wound within the catheter due to the increase / decrease in pressure. The proximal rotating collar 2628 and the RHV The seal 2626 allows the user (e.g., a physician) to account for this length variation and to adjust the agitation accordingly. The agitator 1900 can be advanced / removed relative to the catheter, and the proximal drive assembly By simply moving the stand 2602 in / out of the rotating hemostatic valve 2629, the agitator can be placed in the correct position. If the agitator 1900 is preloaded in the catheter, it can be fixed to the catheter. The distance may initially be set to a nominal position. The proximal rotating collar 2628 may be part of the proximal drive assembly 2602.

[0170] The proximal drive assembly 2602 includes a proximal drive connector 2604 to which a drive unit is connected; and a media inlet port 2610 through which media is infused. The proximal drive assembly also includes a bearing. 2606, which provides a bearing for the proximal drive connector to the proximal drive assembly 2602. The proximal drive connector 2604 is adapted to rotate freely. Rotation of the rotor 2604 is translated into rotation of the wire or hypotube 1900. , may be coupled to the proximal end of the agitator 1900. The proximal drive assembly may further include a drive tube seal. 2608, which is distal from the drive tube seal 2608 (proximal drive assembly 2 602) and the inner lumen proximal to the drive-tube seal 2608. Stop.

[0171] Referring to FIG. 29, the driver 2950 is connected to the proximal drive connector 2604 via the proximal drive connector 2604. The drive assembly 2902 is removably connected to a proximal end thereof. The drive assembly 2950 is , which drives the agitator 1900. The driver 2950 rotates in a direction (CCW / CW), speed, duration, or other factors. The actuator 2950 is a pre-loaded actuator that, when pressed by the control device 2954, e.g. It includes a button that executes a series of programmed steps. The driver 2954 is 2952, in which case the back of the drive 2950 plugs into the sync port 2952. When the driver 2954 is inserted, the driver 2954 drives the stirring body 1900 in synchronization with the suction and injection of the medium. do.

[0172] The clot retrieval system includes an aspiration catheter and a catheter inserted longitudinally into the lumen of the aspiration catheter. An extendable agitator 1900; with or without a synchronization port at the proximal end of the agitator 1900 and a drive unit connectable (e.g., via a rotating hemostatic valve or a proximal drive assembly). The system may allow for impulse aspiration and / or impulse injection of media. The vehicle may be water, saline, or an effective amount of a drug (e.g., heparin, plavitin, The drug may contain a vehicle containing a drug therapy such as plavix or tPA. The components may be operated independently or may be operated in parallel (e.g., synchronized aspiration, injection, and are operated in a synchronized manner with predetermined operating parameters (for rotation and for Good too.

[0173] The method of retrieving a blood clot comprises an aspiration catheter and a catheter extending longitudinally within a lumen of the aspiration catheter. and a drive device coupled to a proximal end of the agitator. placing a catheter adjacent to the clot and attempting to aspirate the clot. if not, advancing the agitator distally through the catheter; activating the drive to rotate the agitator to loosen the clot; and optionally, configured to inject a medium to lubricate the thrombus and / or assist in aspirating the thrombus, generating a medium jet from the distal end of the agitator body; applying a vacuum at the proximal end of the catheter to transport the thrombus proximally within the lumen of the catheter; and optionally, pulsing the vacuum. When a fragment of the thrombus separates, transport may be assisted by the rotating agitator body and / or the injected medium. To dislodge a more stubborn thrombus, aspiration, medium injection, and / or timing of the rotation of the wire or hypo-tube may be coordinated. When excess medium accumulates around the thrombus, a plug is formed. When aspiration is activated and / or applied in a pulsed manner, the vacuum can draw the "plug" proximally within the lumen of the wire or hypo-tube, such as a syringe plunger. Adding more medium maintains a higher local vacuum around the thrombus and applies a greater momentum to the "plug". Coordinating the timing of the rotation of the wire or hypo-tube with aspiration and medium injection may help dislodge or fatigue the thrombus and detach it from the vasculature. Any section of the catheter shaft or telescoping extension compliant with the present invention may include a multi-layer structure having a high degree of flexibility and sufficient pushing ability to reach deep into the cerebral vasculature, for example, at least to the conus, spongy, or cerebral segments of the internal carotid artery (ICA). In one example, referring to FIG. 30, catheter 3000 extends from the manifold to the distal tip

[0174]

[0175]

[0176] ​​​​​​​​​​​​​​The effective length is about 70cm to about 150cm, about 80cm to about 140cm, about 90cm to about 130cm, about 100cm to about 120cm, or about 105cm to about 115cm The outer diameter of the catheter 3000 may be from about 0.07 inches to about 0.15 inches. , about 0.08 inches to about 0.14 inches, about 0.09 inches to about 0.13 inches, About 0.1 inch to about 0.12 inch, or about 0.105 inch to about 0.115 inch The distal segment may be smaller than the proximal segment. In an embodiment, the inner diameter 3108 of the catheter 3000 is about 0.11 inches or more, and preferably about 0.1 inch or more, about 0.09 inch or more, about 0.088 inch or more, about 0.08 inch or more, It may be about 0.07 inches or more, about 0.06 inches or more, or about 0.05 inches or more. The inner diameter 3108 of the catheter 3000 in a single central lumen embodiment is about 0.1 1 inch or less, approximately 0.1 inch or less, approximately 0.09 inch or less, approximately 0.088 inch or less, About 0.08 inches or less, about 0.07 inches or less, or about 0.06 inches or less, or about 0.05 inches or less. Referring to FIG. 30, the inner liner 3014 is A thin dremel (not shown) is formed on the catheter body 3000 by dip coating. A thin walled tubular inner layer may be provided. Dip coating may be performed by applying wire such as silver coated copper wire to the P This may be accomplished by coating the mandrel with TFE. The mandrel is then stretched axially. The inner liner may be removed to reduce its diameter and leave the tubular inner liner. The outer surface of the 3014 is then coated with polyurethane (e.g., Tecoflex 3. Apply a soft tie layer 3012 such as (trademark) to the surface of the adhesive 3012 to a thickness of about 0.005 inches or less. Implementations of this type may produce layers having thicknesses of about 0.001 inches or less. Typically, the distal most 10 or 20 cm of the catheter shaft 3000, typically less than In one implementation, the catheter shaft extends along at least about 50 cm. 3000, 3100 may extend approximately the distal 30 cm.

[0177] Then, a braid such as 75 ppi stainless steel braid 3010 is threaded through the proximal zone. The inner liner 3014 may be wrapped up to the distal transition 3011. A coil 3024, which may include a shape memory material such as gold, is inserted into the catheter 30 from the distal transition portion 3011. 00 distal end of the inner liner 3014. The liner is heated below body temperature so that Nitinol remains in its austenitic (springy) state at body temperature. The adjacent loops or threads of the coil 3024 have a transition temperature in the proximal zone. It is tightly wound and the spacing between adjacent rings is looser in the distal segment. The axial length is between about 20% and about 30% of the total catheter length. 28 cm of catheter shaft 3000 (e.g., 110 cm of catheter shaft 3000) In embodiments having a coil length of at least 1, 2, or 3 mm, 4 cm is at least about 130% of the spacing of the proximal coil segments, and in some implementations, The spacing will be at least about 150% or more. For a 110 cm catheter shaft 3000, the spacing in the proximal coil is approximately 0. 004 inches, and at least about 0.006 inches in the distal section; In embodiments including elongated catheters, the diameter may be 0.007 inches or more. The distal expandable section of the catheter may be constructed as described above. The length of 24 may be the length of the expandable catheter section or the entire length of the catheter 3000 (e.g. The coil 3024 may extend from the distal end of the expandable section. At least about 50%, about 60%, about 70%, about 80%, or about 90% of the length of the shrinkable segment. %. In some embodiments, the catheter 3000 or expandable The expandable section may not include a braid, and the coil 3024 may be located at the proximal end (length It may extend up to 100% of the

[0178] The distal end of the coil 3024 is spaced proximally from the distal end of the inner liner 3014, e.g. For example, a coil may be provided to provide room for an annular radiopaque marker 3040. 3024 may extend proximally from the distal end, in some embodiments, approximately 1 cm, 2 cm, or In one embodiment, the catheter 30 may be in a retracted position, or may be in a retracted position of 3 cm or less. the distal end of the catheter 3000 is at least about 10° relative to the longitudinal axis of the catheter 3000, or An inclined distal surface 3 lying on a plane having an angle of about 20°, in one embodiment about 30° The radiopaque marker 3040 is disposed transversely to the longitudinal axis. Alternatively, at least one of the annular radiopaque markers 3040 may be present on a plane. The distally facing end is angled relative to the longitudinal axis to complement the bevel of the distal surface 3006. It may be an ellipse lying on a plane. Further details are described in relation to FIG. 31D below. Posted.

[0179] After attaching the proximal braid 3010, the distal coil 3024, and the RO marker 3040, the catheter An outer jacket 3020 such as a shrink-wrap tube is attached to surround the thermocouple body 3000. The outer shrink-wrapped sleeve 3020 may be made of polyethylene, polyurethane, Polyether block amide (e.g., PEBAX™), nylon, or other polymers known in the art. It may comprise any of a variety of materials, including others known in the art. This allows the polymer to flow and embed within the proximal braid and distal coil. .

[0180] In one implementation, the outer shrink-wrap jacket 3020 is formed by a number of short tubular sections. 3022, 3026, 3028, 3030, 3032, 3034, 3036, 3038 , and sequentially advance the catheter shaft subassembly concentrically over the catheter shaft subassembly and apply heat to the catheter. The section is then shrunk onto the Thermo 3000 to provide a smooth, continuous outer tubular body. The structure is preferably formed over at least the most distal 10 cm of the catheter body 3000, and more preferably over at least the most distal 10 cm of the catheter body 3000. At least about 20cm, 25cm, 30cm, 35cm, 40cm, or less than 40cm distal The entire length of the outer shrink-wrap jacket 3020 may be formed from the tubular section. The distal tubular sections (e.g., 3022, 3026, 3028, 3030, 3032, 3034, 3036, 3038) from the distal end of the catheter body 3000 20 to provide an abrupt flexibility transition from the outer shrink-wrap jacket 3020 to the outer may be shorter than one or more tubular sections forming a proximal portion of the

[0181] The durometer of the outer wall section may decrease in a distal direction. The proximal section, such as 26, may have a durometer of at least about 60 or 70D. The durometer of successive segments increases distally to a durometer of about 35D or less than 25D. The 25 cm plot is at least about three, or about five, or There may be about seven or more sections, and the entire catheter 3000 may have at least At least about six, eight, ten, or more distinct flexibility zones. The distal one, two, four or more segments 303 may be 6, 3038 has a smaller post-contraction OD than the more proximal segments 3022-3034. This will result in a tapered OD in the finished catheter body 3000. The length of the lower OD section 3004 may range from about 3 cm to about 15 cm. In some embodiments, the distance is within the range of about 5 cm to about 10 cm, for example, about 7 or 8 cm. m, which is accomplished by providing a lower wall thickness in the distal sections 3036, 3038. This may also be the case.

[0182] Referring to FIGS. 31A-31C, the catheter has increased tension resistance in the distal zone. The tension support may further include a tension support for supporting the tension support. The tension support may include a filament. More specifically, one or more axially extending filaments 3042 may be provided. The catheter may include one or more axially extending filaments 3042. The catheter may be disposed axially within the catheter wall near the distal end of the catheter. The filament or filaments 3042 may be under tension (e.g., as the catheter navigates through tortuous blood vessels). Acts as a tensile support to resist stretching of the catheter wall as it is retracted proximally through the system .

[0183] At least one of the one or more axially extending filaments 3042 is Within approximately 1.0 cm of the distal end of the catheter to approximately 5 cm from the distal end of the catheter Full, less than about 10 cm from the distal end of the catheter, less than about 15 cm from the distal end of the catheter, Less than approximately 20 cm from the distal end of the catheter, Less than approximately 25 cm from the distal end of the catheter, less than approximately 30 cm from the distal end of the catheter, less than approximately 35 cm from the distal end of the catheter, The catheter should be inserted no further than approximately 40 cm from the distal end of the catheter or no further than approximately 50 cm from the distal end of the catheter. It may extend proximally along the length of the catheter wall.

[0184] The axially extending filament or filaments 3042 may be about 50 cm or more, about 40 cm or more. cm or more, approx. 35cm or more, approx. 30cm or more, approx. 25cm or more, approx. 20cm or more, approx. 15 The length may be greater than or equal to about cm, greater than or equal to about 10 cm, or greater than or equal to about 5 cm.

[0185] At least one of the axially extending filaments 3042 is about 50 cm or less, about 40 cm or less, about 35 cm or less, about 30 cm or less, about 25 cm or less, about 20 cm or less, approximately 15 cm or less, approximately 10 cm or less, or approximately 5 cm or less in length At least one of the one or more axially extending filaments 3042 The catheter is inserted into the distal portion of the catheter at least about 50 cm away from the catheter. Approximately 40 cm distal to the catheter, at least approximately 35 cm distal to the catheter length. At least about the most distal 30 cm of the length, at least about the most distal 25 cm of the length of the catheter 2. About 20 cm of the distal end of the catheter, about 20 cm of the distal end of the catheter, Approximately 15 cm distal to the catheter, at least approximately 10 cm distal to the catheter length, or The distal end of the distal end of the distal tip may extend for at least about 5 cm of the length of the distal tip.

[0186] In some implementations, the filament extends along the length of the coil 24 and out of the distal end of the catheter. 3024 and extending proximally from either side of the transition 3011 between the coil 3024 and the braid 3010. The filament terminates proximally within about 5 cm or 2 cm or less of the braid 3010. 3011. Alternatively, the two lines may terminate at transition 3011 without overlapping.

[0187] In another embodiment, the most distal portion of the catheter 3000 is made of a highly flexible To form the distal portion of the and may have a length between about 25 cm and about 35 cm. A section may contain one or more tubular sections of the same durometer (e.g., section 3038). A series of proximally adjacent tubular sections may be provided to define a proximal rigid portion of the catheter 3000 and a distal rigid portion of the catheter 3000. A transition region may be formed between the highly flexible portion of the tube and the highly flexible portion of the tube. The shaped sections have the same or substantially similar lengths, e.g., approximately 1 cm in length. It's fine.

[0188] The relatively short series of tubular sections provides a steep drop in durometer across the transition region. For example, the transition region may include a proximal tubular section having a durometer of about 35D. The distal portion may have a proximal segment 3036 adjacent to the distal portion. 034 may have a durometer of about 55D. The adjacent proximal section 3032 may have a durometer of about 55D. The adjacent proximal section 3030 may have a durometer of about 72D. It may have a durometer.

[0189] The more proximal section may include a durometer greater than about 72D; and The catheter may extend to the proximal end of the catheter or the elongated catheter section. The tube segment includes a proximal portion greater than approximately 72D, between about 1 cm and about 3 cm. In some embodiments, the proximal portion may be about 2 cm in length. In some embodiments, the distal most section (e.g., 3038-3030) is made of Pebax (PE BAX™), and the proximal section is generally made of a harder material, e.g. For example, Vestamid® may be included.

[0190] The inner diameter of the catheter 3000 or catheter extension section is approximately 0.06 inches and Between .08 inches, approximately between .065 inches and .075 inches, or approximately .06 The inner diameter may be between 0.8 inches and 0.073 inches. In some embodiments, the inner diameter is about 0. It is .071 inches.

[0191] In some embodiments, the distal most portion may be tapered inwardly as described elsewhere herein. The taper may be approximately from a distal highly flexible section to a transition region. (eg, over the proximal-most portion of the distal highly flexible portion). The taper may be relatively gradual (e.g., occurring over about 10 cm or more). or may be relatively abrupt (e.g., occurring over less than about 5 cm). may taper to an inside diameter of between about 0.03 inches and about 0.06 inches. For example, the inner diameter at the distal end of the catheter 3000 may be about 0.035 inches, about 0.04 inches, or about 0.06 inches. 5 inches, or about 0.055 inches. In some embodiments, the inner diameter is , may be constant over at least the catheter extension section.

[0192] In some embodiments, the coil 3024 extends from the distal end of the catheter 3000 at a high The distal end of the distal end of the transition region may extend proximally along the flexible distal portion and terminate at a distal end of the transition region. In this embodiment, the coil 3024 is transitioned from the distal end of the catheter to the proximal end of the transition region. It may extend to a point along the row region or proximally beyond the transition region. In this embodiment, the coil 3024 may be attached to a catheter 3000 or catheter 3022, as described elsewhere herein. The braid 3010, if present, may extend the entire length of the catheter extension section. From the proximal end of the coil 3024 to the proximal end of the catheter 3000 or catheter extension section It may be extended.

[0193] The axially extending filament or filaments 3042 may be disposed within the tie layer 3012 or the inner The axially extending pipe 3014 may be disposed adjacent to or radially outward from the side liner 3014. The filament or filaments 3042 may be attached to the braid 3010 and / or the coil 3024. The axially extending filaments may be disposed proximal or radially inward. The support 3042 may be supported between the inner liner 3014 and the helical coil 3024. stomach.

[0194] One or more axially extending filaments 3042 are disposed within the catheter wall. When present, the axially extending filaments 3042 may be arranged radially symmetrically. For example, between two filaments 3042 extending axially relative to the radial center of the catheter. The angle may be approximately 180 degrees. Alternatively, the angle may be adjusted to accommodate the desired clinical performance (e.g., flexibility, In response to the force of the axially extending filaments 3042, the filaments 3042 are arranged to be asymmetric in the radial direction. Any two axially extending catheters may be arranged in a radial direction. The angle between the filaments 3042 may also be less than about 180 degrees, less than about 165 degrees, or less than about 150 degrees. , about 135 degrees or less, about 120 degrees or less, about 105 degrees or less, about 90 degrees or less, about 75 degrees or less, about 60 degrees or less, approximately 45 degrees or less, approximately 30 degrees or less, approximately 15 degrees or less, approximately 10 degrees or less, or approximately 5 degrees It may be the following.

[0195] The axially extending filament or filaments 3042 may be made of Kevlar ), polyester, meta-para-aramid, or The shaft may be made of any combination of these materials. At least one of the filaments 3042 may be a single fiber or a bundle of multiple fibers. The fibers or bundles may have a circular or rectangular cross section. The term filament or sintered fiber does not convey composition but is a function of design considerations, e.g. Depending on the desired tensile fracture limit and wall thickness, a variety of high tensile polymers, metals, or alloys are available. The cross-sectional dimension of the axially extending filament or filaments 3042 may include is about 1%, 2%, 3%, 4% of the cross-sectional dimension of the catheter 3000, measured in the radial direction. ,5%,6%,7%,8%,9%,10%,11%,12%,13%,14%,15%, The thickness of the axially extending flute may be less than 20%, 25%, or 30%. The cross-sectional dimension of filament 3042 is approximately 0.001 inches, approximately 0.0 02 inch, approx. 0.003 inch, approx. 0.004 inch, approx. 0.005 inch, approx. 0.0 06 inch, approx. 0.007 inch, approx. 0.008 inch, approx. 0.009 inch, approx. 0.0 10 inches, approximately 0.015 inches, approximately 0.020 inches, approximately 0.025 inches, or approximately It may be 0.030 inches or less.

[0196] The axially extending filament or filaments 3042 are arranged in the distal zone of the catheter. Tensile strength is at least about 1 lb., at least about 2 lb., at least about 3 lb., or less. At least about 4 pounds, at least about 5 pounds, at least about 6 pounds, at least about 7 pounds , at least about 8 pounds, or at least about 10 pounds, or more It may be possible.

[0197] Any of the aspiration catheters or tubular extension sections disclosed herein may include an axial filament. The catheter may have a beveled distal tip, with or without a distal tip. Referring to FIG. 31D, a distal catheter tip 3110 includes an advancement section 3114 and a marker. The tubular body 3112 includes a band 3116 and a proximal section 3118. The inner 3120 may extend the entire length of the distal catheter tip 3110, The material may include PTFE that is dip coated.

[0198] A reinforcing element 3122, such as a braid or spring coil, is embedded in the outer jacket 3124. The jacket may extend the entire length of the distal catheter tip 3110.

[0199] The forward section 3114 terminates distally at an angled surface 3126 to define a marker band 3116. 16. A leading sidewall portion having a length measuring the dimension between the distal end 3130 and the distal tip 3132. 3128. A trailing sidewall portion 3134 of the forward moving section 3114 is provided in the illustrated embodiment. The catheter has an axial length extending from the leading side wall portion 3128 to the leading end of the catheter. approximately equal to the axial length of the preceding sidewall portion 3128, measured approximately 180 degrees around the tail. The leading sidewall portion 3128 has an axial length within a range of about 0.1 mm to about 5 mm. The axial length may be generally within the range of about 1 to about 3 mm. The trailing sidewall portion 3134 may be axially spaced from the leading sidewall portion 3128 depending on the desired performance. at least about 0.1, or about 0.5, or about 1 mm, or about 2 mm, Or it may have a shorter length.

[0200] The beveled surface 3126 is angled from about 45 degrees to about 80 degrees from the longitudinal axis of the catheter. In one implementation, the angle A is within a range of about 55 degrees to about 65 degrees, all That is, within a range of about 55 degrees to about 65 degrees from the longitudinal axis of the catheter. In this example, angle A is about 60 degrees. One consequence of angle A being less than about 90 degrees is that the distal The extension of the major axis of the port area increases the surface area of ​​the port, which improves the absorption of blood clots. In some cases, this can enhance traction or retention. Compared to the surface area of ​​a circular port (angle A is 90 degrees), In comparison, the area of ​​a beveled port is generally at least about 105% and no more than about 130%. , in some implementations in the range of about 110% and about 125%, and in one example about 115%.

[0201] In an exemplary embodiment, the axial length of the advancement section is substantially uniform around the circumference of the catheter. As a result, the beveled surface 3126 is approximately parallel to the distal surface 3136 of the marker band 3116. The marker band 3116 is approximately transverse to the longitudinal axis of the catheter and proximal to the This results in a marker band 3116 having a right trapezoidal configuration in the side elevation view. The short side wall 3138 is rotationally aligned with the trailing side wall 3134 and is spaced apart by about 0.2 mm. axial length in the range of about 0.5 mm to about 2 mm, and typically in the range of about 0.5 mm to about 2 mm The opposing long sidewall 3140 is rotationally aligned with the preceding sidewall portion 3128. The long sidewall 3140 of the marker band 3116 is generally less thick than the short sidewall portion 3138. 3138. At least about 10%, or about 20% longer than the short sidewall portion 3138, depending on the desired performance. At least about 50%, or about 70%, or about 90%, or even longer. Generally, the long sidewall 3140 is at least about 0.5 mm or 1 mm, and preferably at least about It will have a length of less than 5 mm or 4 mm.

[0202] The marker band is axially aligned along its entire length to allow for radial expansion. having at least one, and optionally two, or three, or more slits extending therethrough. The slits may be located on or off the short sidewall 3138 depending on the desired bending characteristics. The marker strips may be located on or between the long side walls 3140. Various radiating devices have wall thicknesses of approximately 0.003 inches or less, and in one implementation, approximately 0.001 inches. It may comprise any radiopaque material, such as a platinum / iridium alloy.

[0203] The marker band zone of the assembled catheter has relatively high bending stiffness and high crush strength. degree, e.g., at least about 50% or at least about 100% smaller than the proximal segment 18; However, it will generally have a size that is no more than about 200% smaller than the proximal section 3118. The high crush strength provides a radially inwardly extending portion 3114, particularly the leading sidewall portion 3128. directional support may be obtained, providing an atraumatic cushion during transluminal advancement. This allows the distal tip 3132 to function better and resist shrinking under vacuum. The forward section 3118 preferably has a lower bending stiffness than the marker band zone, and the forward section 3119 preferably has a lower bending stiffness than the marker band zone. 114 preferably has a lower bending stiffness and crush strength than the proximal section 3118. do.

[0204] The forward movement section 3114 is attached to the outer periphery of the marker band 3116 without any other internal support structure distal to the marker band 3116. Jacket 3124 and optionally a distal extension of inner liner 3120 . The outer jacket may include extruded Tecothane. The forward section 3114 is approximately 50% or less shorter than the corresponding value for the proximal section 3118. , in some implementations, bending stiffness of about 25%, or about 15%, or about 5% or less; It may have a radial crush stiffness.

[0205] Support fibers 3142, as discussed elsewhere herein, extend along the length of the proximal section 3118. 31. As illustrated, the support fibers 3142 extend through at least the distal portion of the marker band 31. 16 and may terminate distally at a proximal surface of the tubular liner 3120 at an axial radius of The fibers 3142 may extend radially outward from the support coil 3122 and radially inward from the support coil 3122. may extend substantially parallel to the longitudinal axis or may be inclined to extend along the length of the helix. 10, or 7, or 3, or 1, or less times around the catheter along the It may be in a gentle spiral with a complete turn. The fiber is Vectran Multif Filament LCP (Vectran multifilament LCP) fiber, etc. It may also include high tensile materials such as multifilament yarns spun from liquid crystal polymers. .

[0206] 32A-32C, the catheter 3000 is sufficiently far to reach the target site. Depending on whether the catheter can be navigated to a desired location, an intraluminal catheter 3200, for example, 3A and 3B, a telescopic extension section having a proximally extending control wire as shown in FIG. B) from the proximal end of the catheter 3000 through the catheter 3000. The intraluminal catheter 3200 may be inserted into the catheter at a distal end thereof. The catheter 3000 is inserted so as to reach a more distal end. The outer diameter of the catheter 3200 is smaller than the inner diameter of the catheter 3000. The inner catheter 3200 can slide within the lumen of the catheter 3000.

[0207] The intraluminal catheter 3200 has the same sidewall structure as the catheter 3000 described herein. The axial length of the tubular extension section is approximately 5 times the length of the catheter 3000. The axial length of the tubular extension section may be less than about 0%, and typically less than about 25%. Generally, at least about 10 cm, or about 15 cm, or about 20 cm, or about 25 cm m or more, but generally no larger than about 70 cm, or about 50 cm, or about 30 cm It will be below.

[0208] 33A to 33C, the intraluminal catheter 3200 is a single axially extending catheter. The filament may have one or more filaments 3242 extending in the axial direction. The filament 3242 may be one or more filaments extending in the axial direction of the catheter 3000. The catheter 3200 incorporates the properties of the filament 3042, but The cross-sectional dimensions, measured in the radial direction, of one or more axially extending filaments 3242 The diameter may be smaller than the corresponding dimension of the filament 3042 of the catheter 3000. That is a different matter.

[0209] 34A-34B, a progressively flexible catheter of the type discussed in connection with FIG. An example of a layering pattern of the outer jacket section toward the distal section 3 is shown. 038 is a tubular tube with a length in the range of about 1-3 cm and a durometer of about 35D or less than 30D. The adjacent proximal section 3036 may have a length in the range of about 4 to about 6 cm. and may have a durometer of about 35D or less than 30D. 3034 has a length within the range of about 4 to about 6 cm and a durometer of about 35D or less. The adjacent proximal section 3032 may be in the range of about 1 to about 3 cm in length and about It may have a durometer in the range of 35D to about 45D (e.g., 40D). The adjacent proximal section 3030 has a length in the range of about 1 to about 3 cm and a width of about 50D to about 60D. The proximal section may have a durometer in the range of about 55D (e.g., about 55D). 3028 has a length in the range of about 1 to about 3 cm, and a length of about 35D to about 50D to about 60D. The proximal section may have a durometer in the range of about 55D (e.g., about 55D). 3026 has a length in the range of about 1 to about 3 cm, and at least about 60D, typically The more proximal section may have a durometer of at least about 65D. The distal most two or three segments may have a durometer of about 70D or about 70D. The more proximal section may contain materials such as Tecothane, (PEBAX), or other catheter jacket materials known in the art. At least three, or five, or seven, or nine, or more These sections may be utilized at the maximum along the length of the catheter shaft. The change in durometer between the highest and lowest is at least about 10D, preferably at least about 2 0D, and in some implementations at least about 30D, or 40D, or even more. minutes.

[0210] Catheter performance indicators include backup support, tracking ability, pushability, and kink resistance. Backup support means that the catheter remains in the correct anatomical position and is supported by the body. This refers to the ability to provide a stable platform from which an intraluminal device can be advanced. See Figure 35. In light of this, when the device is pushed through the catheter 3202, the catheter 3202 Without sufficient backup support within the catheter 3202, the distal portion 3204 of the catheter 3202 may become 3. Blood vessels branching from the nasal canal (e.g., brachiocephalic artery 82, common carotid artery 80, or subclavian artery 84) 206 may escape, withdraw, or regress from it. The backup support of the Teru 3202 is the proximal region with a high durometer or modulus. and a distal region having a lower durometer or modulus of elasticity. The durometer or modulus of the proximal region of the catheter 3202 may be increased by the braid. The catheter may be improved by increasing the durometer or modulus. The area includes the aortic arch 1114, 1214, the brachiocephalic artery 82, the common carotid artery 80, or the clavicle. near the bifurcation point where the main vessel branches into the inferior artery 84 or into one or more smaller Others that branch into the blood vessels and cause the catheter to prolapse with poor backup support It may be placed near an anatomical structure (i.e., a bifurcation). Alternatively, the area of ​​the catheter with enhanced elasticity may be used to guide the catheter through one or more smaller major blood vessels. Approximately 0.5cm, 1cm, 2cm, 3cm, 4cm from the branching point into the other blood vessels, It may be located within a range of about 5 cm, or about 6 cm.

[0211] Trackability refers to a catheter that tracks further distally (e.g., to M1) than other catheters. For example, the ability to reach the cerebral division of the internal carotid artery (ICA) The catheter is more flexible than a catheter that can reach the cavernous or petrous division of the ICA. The catheter has better tracking ability than catheters with low durometer or modulus. By using a catheter wall that is In some cases, this can be improved by adding a coating such as a hydrophilic coating. A hydrophilic coating may be disposed along the distal-most region of the catheter. The coating may be located about 1 cm, about 5 cm, about 10 cm, about 15 cm, or about 20 cm from the distal end of the catheter. The area having a lower durometer or modulus of elasticity may extend up to about 20 cm. The region having a lower durometer or modulus of elasticity may be located in the distal most region of the distal end of the catheter. is about 1 cm, about 5 cm, about 10 cm, about 15 cm, or about 2 cm from the distal end of the catheter. It may extend to 0 cm.

[0212] Pushability means that the material has enough force to be pushed through the anatomy without "buckling". The pushability of a catheter is determined by its durometer or modulus of elasticity. In addition, the pushability of the catheter can be improved by increasing the dura a proximal region having a lower durometer or modulus and a distal region having a lower durometer or modulus The durometer or modulus of elasticity may be improved by providing a region. along its length in the axial direction (e.g., durometer or elasticity from the proximal end to the distal end). The transition region of the catheter is approximately 50% to 60% of the length of the catheter from its proximal end. It may start at %, 70%, 75%, 80% or even higher.

[0213] Kink resistance means that the catheter is less likely to kink. If the catheter is kinked during use, its kink resistance helps it return to its original shape. Kink resistance is important in the distal section of the catheter, which is weaker than the proximal section. The kink resistance of a catheter is determined by the presence of one or more Ni By adding a Ti coil (or a coil at least part of which is Nitinol) This may improve the situation.

[0214] FIG. 36 shows a graph of the catheter length from the proximal end (x=0) to the distal end (x=1). 1 illustrates a graph of the durometer or modulus of elasticity of a catheter according to the present invention. The conformal catheter has a decreasing durometer or elasticity as it approaches its distal end. The proximal end of the catheter may have a higher density (E) than the distal end of the catheter. The higher durometer or modulus near the proximal end allows for Provides excellent back-up support for the catheter. Catheter durometer or modulus is substantially constant along the length of the catheter near its proximal end 3302. The durometer or modulus of the catheter decreases near the distal end 3304 of the catheter. The durometer or modulus of a catheter is measured over the length of the catheter from its proximal end. The decrease may begin at about 50%, about 70%, about 75%, 80%, or about 90%. (i.e., the transition region). The catheter has a smaller durometer or elasticity near the distal end. By using materials with high thermal conductivity or having a catheter wall that is thin therein. , and may have a gradually decreasing durometer or modulus of elasticity near the distal end. The reduced durometer or modulus near the distal end provides excellent catheter trackability. can be.

[0215] FIG. 37 shows a flexibility test pattern of a catheter according to the present invention compared to a conventional catheter. The catheter flexibility was measured using a 1 inch span and 2 mm displacement. In other words, in FIG. 37, the stress release (i.e., the catheter The distance from the proximal end of the catheter to the point of force application was determined by a 1 inch long catheter section. The force required to displace 2 mm in the vertical direction (i.e., bending load) is shown in Figure 37. All catheters tested in this study had similar modulus or elasticity to those shown in Figure 36. The catheter has a flexural profile showing its elastic modulus along its length near the proximal end. remains substantially constant until the distal end and then gradually decreases near the distal end.

[0216] Catheters according to the invention have a substantially constant, The bending load decreases rapidly near the distal end. The catheter is about 85 cm from the proximal end, with a pressure of about 1.0 lbF and about 1 .5lbF, about 2.0lbF, about 2.5lbF, about 3.0lbF, or about 3.5lbF The catheter may have a bending load of about 95 cm from the proximal end. Approximately 2.5 lbF, approximately 2.0 lbF, approximately 1.5 lbF, approximately 1.0 lbF, or approximately 0.5 liters The catheter may have a bending load of 0.15 to 0.25 mm or less. The catheter may have a bending load of 0.15 to 0.25 mm or less. Approximately 1.5 lbF, approximately 1.0 lbF, approximately 0.75 lbF, approximately 0.5 lbF, approximately 0.2 The catheter may have a bending load of about 5 lbF or less, or about 0.1 lbF or less. At approximately 115 cm from the end, the values ​​are approximately 1.0 lbF, 0.75 lbF, and 0.5 lbF. , about 0.4 lbF, about 0.3 lbF, about 0.2 lbF, or about 0.1 lbF or less of bending For catheters having different lengths, the dimensions may vary depending on the catheter. The catheter can be scaled from its distal end as a percentage of its length.

[0217] In a particular implementation constructed in accordance with Figure 30, the bending load is Less than approximately 3.0 or 3.25 lbF at the tip and 65 cm to 85 cm from the proximal end The bending load averages about 90% of the proximal end and is greater than about 2.25 or 2.5 lbF. At 5 cm, the pressure drops to about 1.0 lbF or less, preferably about 0.5 lbF or less. This allows for excellent back-up in the aorta while maintaining excellent compliance with the distal vasculature. Support is gained.

[0218] In another embodiment, the catheter has a pressure of about 1.0 lbF at about 60 cm from the proximal end. , about 1.5 lbF, about 2.0 lbF, about 2.5 lbF, about 3.0 lbF, or about 3.5 The catheter may have a bending load of 1.2 lbF or more. The catheter is 2.0 lbF, 1.5 lbF, 1.0 lbF, or 0.5 lbF or less The catheter may have a bending load of about 1. 0lbF, approx. 0.75lbF, approx. 0.5lbF, approx. 0.4lbF, approx. 0.3lbF, approx. 0 The catheter may have a bending load of about 0.2 lbF or less, or about 0.1 lbF or less. At approximately 90 cm from the proximal end, approximately 1.0 lbF, approximately 0.75 lbF, and approximately 0.5 lbF , about 0.4 lbF, about 0.3 lbF, about 0.2 lbF, or about 0.1 lbF or less of bending It may have a load.

[0219] The catheters are available in a variety of sizes, including about 1.0 lbF, about 1.5 lbF, about 2.0 lbF, about 2.5 lbF, having a transition region that changes the bending load by about 3.0 lbF or more than about 3.5 lbF The longitudinal length of the transition region may be about 20 cm, about 15 cm, about 10 cm, about 5 cm, about 3 cm, or about 1 cm or less.

[0220] Neuron Max (Penumbra, I nc))) 3402, compared to catheters according to the present invention (e.g., 3404, 3406 , 3408, 3410) have similar elastic moduli near their proximal ends. The catheter according to the present invention provides backup support equivalent to that of Neuron Max. In addition, these catheters have a nucleation zone near the transition area (between the proximal and distal ends). It has a modulus of elasticity that declines more rapidly than that of Lon Max.

[0221] Ace 68 Catheter (Penumbra) 3412, Ace 64 64) Catheter (Penumbra) 3414, Benchmark 71 71) Catheter (Penumbra) 3416, and Sofia Plus (Sofia Pl us (MicroVention) 3418, this invention Catheters according to the invention have a greater modulus of elasticity near their proximal ends and a similar modulus near their distal ends. Thus, the catheter according to the present invention has a modulus of elasticity greater than that of the conventional catheter. In comparison with the above, excellent backup support with the same degree of compliance is obtained. The catheters have inner diameters (and therefore lumen volumes) of ACE 68, ACE 64, , Benchmark 71, and Sophia Plus, 0.064 inches to 0.071 inches This modulus profile may be achieved even with inner diameters in the range up to 100 mm. .

[0222] Referring to FIG. 38, a deformable access sheath 200 is illustrated. The base 200 includes an elongated, flexible tubular body 202 extending between a proximal end 204 and a distal end 206. The proximal access port 208 is connected to a distal port on the distal end 206 via a central lumen 212. It communicates with port 210. See FIG.

[0223] At least one transition zone 214 is provided on the tubular body 202. 14 is controllably deformable between a relatively rigid configuration and a relatively flexible configuration. The access sheath 200 may be configured as desired, for example, to provide column strength or to accommodate At least one transition zone having a relatively rigid configuration to facilitate the introduction of instruments therethrough. 214 may be used to advance distally through tortuous anatomy. 214 may be relatively flexible, for example to navigate tight bends in the vasculature, if desired. The stimuli may be controllably transformed into a sexual configuration.

[0224] In the illustrated embodiment, three transition zones 214 are shown. However, as desired One, two, three, four or more transitions depending on clinical performance A transition zone 214 may be used, ranging from about 1 cm to about 20 or 30 cm. In certain embodiments, the transition zone may be about 2 mm or longer in length. The length and location of the transition zone are within the range of about 10 cm to about 20 cm. The size of the catheter may depend on the target anatomy and can be positioned accordingly.

[0225] Referring to FIG. 39, taken along line 18-18 of FIG. 38 through transition zone 214. The tubular body 202 includes at least one heating element 218. a sidewall 216 having a heating element supported by the sidewall 216; or In the illustrated embodiment, the heater 218 is a conductive spiral coil. The conductive filament may be a conductive wire such as a wire or a braid. , may be disposed within the inner and outer layers of the sidewall 216 or may be laminated. In at least one embodiment, the inner layer of the sidewall 216 is made of polytetrafluoroethylene for lubricity. In at least one embodiment, the sidewall 216 may include a PTFE. The outer layer preferably comprises a biocompatible material having a glass transition temperature of about 40° C. to about 80° C. It's okay to do that.

[0226] Alternatively, a conductive polymer may be used to form the sidewall 216. Alternatively, the sidewall 216 may be printed, laminated, embedded, or otherwise formed on the exterior, interior, or exterior of the sidewall 216. If desired, they may be attached to or laminated within the inner and outer layers. In at least one embodiment, the resistance of the heater 218 is set to: It may be calibrated to a specific heating temperature, for example 40 to 80°C. This eliminates the need for a thermocouple. This may help prevent potential overheating.

[0227] One or more electrical conductors extend between the transition zone 214 and the proximal actuation port 215. and adapted to couple to a power source from an external controller. A single conductor for each transition zone 214 may extend proximally to the actuation port 215 . As understood in the art, a catheter is used to conduct electricity through the patient's body to an external electrode. To this end, a second conductor may be connected to a conductive surface on the tubular body 202 or Alternatively, in bipolar embodiments, each transition zone 214 may include a surface. There may be at least two electrical conductors extending proximally to the movement port 215.

[0228] At least the transition zone is relatively stiff at body temperature (e.g., 37°C) but becomes stiffer when heat is applied. The material may be biocompatible, transitioning to a relatively soft and flexible material. It has a relatively low melting point so that it can be softened at temperatures that are not high enough to damage blood vessels. Regardless, the material has a softening point or glass transition temperature above body temperature. The melting point is significantly higher than body temperature and can be reached by activating the heating component 218. In one embodiment, the biocompatible material is preferably heated to a temperature of about 40° C. to about 8 A polymer that has a glass transition temperature of 0° C. when heated, causing the polymer to break apart. Suitable materials may include polymers with chain orientation.

[0229] Examples of suitable bioabsorbable materials are polymers, typically polyolefins and polyurethanes. Typical polymers include thermoplastic polymers such as cellulose acetate, cellulose ether, and most other biocompatible polymers. Suitable bioabsorbable materials include polyglycolide (PGA), poly(L-lactide) (PL Poly(ε-caprolactone) (LA), poly(ε-caprolactone) (PCL), and blends or combinations thereof For example, polyglycolide has a glass transition temperature between 35 and 40°C. which has a fairly high melting point.

[0230] Typical operating (softening) temperatures in this respect are on the order of between about 40°C and 80°C, with transition to cause a softening transition of zone 214, and then turn off the power to allow transition zone 214 to reach body temperature. It is placed at a temperature between about 40°C and 60°C so that it can transition back to a solid state when cooled. Temperatures above about 80°C can be reached for short periods of time, depending on the total energy delivered. There is no limit to what temperature the heater 218 can reach. This restriction can be achieved without causing damage to the vessel wall or without causing the formation of thrombus. It all depends on what the patient's body can handle. For this reason, suitable polymers If the material exhibits appropriate flexibility at its softening point temperature and appropriate hardness at a lower body temperature, It may be desirable to stay within the lower end of the temperature range illustrated in .

[0231] The energy activated biocompatible transition zone 214 softens when heated to For example, this material allows the robot to navigate through tight bends. It is said that the application of energy makes it soft enough to increase its flexibility, but It retains the structural integrity necessary for gating and hardens back to its original configuration when the heat source is discontinued. To maintain the integrity of the tubular body, the sidewall 216 is spirally The wires may be wound, ribbons, or polymeric threads such as polyimide, or neurovascular catheters. Flexible reinforcements, such as other braids or wovens as understood in the electrical art. A resistive coil or other resistive filament may also be provided in the transition zone. While in the softened state it may provide a mechanical reinforcement function.

[0232] Heating is achieved by inserting a resistive heat component supported by a heat source, e.g., a heater catheter, into a central lumen. Alternatively, this may be accomplished by positioning the catheter within the vascular system 212. Once the heater catheter has reached its final position within the central lumen 212, it may be withdrawn proximally from the central lumen 212. The central lumen is now open for aspiration or to receive the distal section 34 therein. In either heater configuration, the power source is connected to the suction catheter or may be provided inside the proximal manifold on the heater catheter or electrically connected to it. They may also be bonded selectively.

[0233] Suitable access for the catheter of the present invention is via the peripheral arteries, e.g., the right femoral artery, the left femoral artery, Right radial artery, left radial artery, right brachial artery, left brachial artery, right axillary artery, left axillary artery, right subclavian artery This can be accomplished using conventional techniques through an incision in the left subclavian artery or left subclavian artery. In an emergency, either the right or left carotid artery can be cut open.

[0234] By avoiding a tight fit between the guidewire 40 and the inner diameter of the guidewire lumen 28, The catheter slides easily over the guidewire. In ultra-small catheter designs, the catheter 10 moves axially relative to the guidewire 40. , the outer surface of the guidewire 40 and / or the inner surface of the lumen 38 defining the wall thereof may be coated with a lubricious coating. It may be desirable to coat the surface with various coatings, such as Paralene. ), Teflon, silicone, polyimide-polytetrafluoroethylene composite, or Utilizing a guidewire or other suitable means known in the art depending on the inner tubular wall 38. This is also fine.

[0235] Aspiration catheters of the present invention adapted for intracranial applications generally have a length of about 60 cm to about 2 It has a total length in the range of 50 cm, usually in the range of about 135 cm to about 175 cm. 33 is typically about 20 cm to about 220 cm in length, more typically about 100 cm to about The length of the distal section 34 is typically from 10 cm to about 60 cm. range, usually from about 25 cm to about 40 cm.

[0236] The catheters of the present invention have suitable properties when formed into a tubular catheter body section. The material may be composed of any of a variety of biologically compatible polymeric resins. Typical materials include polyvinyl chloride, polyether, polyamide, polyethylene, and polyurethane. In one embodiment, the proximal body Both section 33 and distal body section 34 will comprise polyvinyl chloride (PVC); The proximal body section is constructed from a relatively stiff PVC, while the distal body section is relatively flexible. Optionally, the proximal body section is formed from a metallic or polymeric braid. or other conventional reinforcing layers.

[0237] The proximal body section is adapted to axially position the catheter through the guide catheter. and at least a portion of the proximal body section 33 exhibits sufficient column strength to enable , which extends beyond the guide catheter into the patient's vascular system. Shore hardness ranging from D to 100D, often from about 70D to about 80D Typically, the proximal shaft has a resistance of 20,000 psi to 1,000,000 psi. si, preferably in the range of 100,000 psi to 600,000 psi flexural modulus The distal body section 34 is adapted to navigate the narrower distal vasculature of the patient. In a highly flexible embodiment, The Shore hardness of the distal body section 34 may range from about 20A to about 100A, The flexural modulus of section 34 may be from about 50 psi to about 15,000 psi.

[0238] The catheter body may contain other components, such as radiopaque fillers; colorants; reinforcing materials; a reinforcing layer, such as a braided or helical reinforcing element; and the like. In particular, the proximal body section preferably has a limited wall thickness and outer diameter while maintaining its column strength. It may be reinforced to improve strength and torqueability (torque transmission).

[0239] Typically, radiopaque markers are provided at least at the distal end 14 and distal to the proximal section 33. The radiopaque marker is located at the end transition region 32. The band may be completely embedded or surfaced on the exterior of the distal end of the proximal body section 33. Suitable marker bands are available in a variety of materials including platinum, gold, and tungsten / rhenium alloys. Preferably, the radiopaque marker band has a smooth outer surface. It will be embedded within the annular channel to create a surface.

[0240] The proximal section 33 of the tubular body 16 may be made using any of a variety of known techniques for manufacturing interventional catheter bodies. The implant may be fabricated according to any suitable technique, for example by extrusion of a suitable biocompatible polymeric material. Alternatively, at least a proximal portion or all of the length of the tubular body 16 may be made of polystyrene. Polymer or metallic spring coils, solid wall hypodermic needle tubing, or braided reinforced wall The catheter may include a catheter-like device, as is known in the microcatheter art.

[0241] In catheters intended for neurovascular applications, the proximal section 33 of the body 16 is typically about The outer diameter may range from 0.117 inches to about 0.078 inches. The proximal section 33 has an OD of about 0.104 inches and an ID of about 0.088 inches. The distal section 34 has an OD of about 0.085 inches and an ID of about 0.070 inches. do.

[0242] Diameters outside the preferred range may also be used, provided that the functional consequences of the diameter are: Provided that it is acceptable for the catheter's intended purpose, e.g. The lower limit of the diameter of any portion of the tubular body 16 in a given application is determined by the minimum allowable suction flow rate. and contraction resistance, as a function of the number of fluid or other functional lumens contained in the catheter. It becomes.

[0243] The tubular body 16 is adapted to guide the catheter to a distal location without buckling or undesirable bending of the tubular body. Sufficient structural integrity (e.g., column strength or For example, it must be possible to avoid twisting during rotation and to operate it smoothly. To aid in the operation, torque transmission capability of the tubular body 16 may also be desirable. In particular, the distal section 34 may include any of a variety of structures that enhance torque and / or column strength. For example, the reinforcing wires may be axially extending, a spirally wound support layer, or a braided or Reinforcing filaments, such as woven or woven reinforcing filaments, may be incorporated into or on the tubular body 16. They may also be laminated. See, for example, U.S. Pat. No. 5,399,343 to Chien, et al. See US Pat. No. 5,891,114, the disclosure of which is incorporated herein by reference in its entirety. Be absorbed.

[0244] In many applications, the proximal section 33 is particularly suitable for traversing low profile or tortuous arteries. For example, the proximal section 33 may be largely or entirely of a relatively large diameter. The transition portion 32 is located approximately at the distal end of the guide catheter. It can be positioned on the catheter shaft 16 to coincide with or extend beyond it. Cut.

[0245] For certain applications, such as intracranial catheterization, the distal section 34 preferably comprises at least Both are about 5 cm or 10 cm long and 3 mm or 2 mm or less in diameter. The distal segment is of sufficient diameter to pass through blood vessels as small as 10 mm in diameter. or at least about 20 cm, or about 30 cm, or about 40 cm, depending on the area to be treated , or even longer.

[0246] The distal section may be supported within the proximal section as an integrated device or may be attached to the proximal section during the procedure. Regardless of whether it is a separate device inserted into the compartment, it is substantially shorter than the proximal compartment. When the distal end of the distal section and the distal end of the proximal section are axially aligned, the proximal end of the distal section is A control element, such as a control wire or tube, is spaced distally from the proximal end of the proximal section. , spanning the distance between the proximal end of the distal section and the proximal manifold or proximal control device. There are.

[0247] In this configuration, the proximal end of the distal section is generally spaced distally from the proximal end of the proximal section. At least about 25%, and in some embodiments at least about 50%, or 70% or more.

[0248] According to one embodiment, a proximal section having at least one lumen and a distal end portion axially movable within the lumen. a distal section positioned in the proximal section; and a first flexible tubular body having a first groove in the proximal section. from a proximal retracted position to a second extended position that extends distally beyond the proximal segment; and an active tip on the distal end of the distal section, the smaller of the components. and a distal opening movable between a distal end and a larger configuration. Telephone is provided.

[0249] In one aspect of the present disclosure, the control device includes a puller wire that extends through the proximal section. In another embodiment of the disclosure, the distal segment extends beyond the proximal segment by a distance of at least about 10 cm. In yet another aspect of the present disclosure, the distal section comprises at least It can also be advanced distally to extend beyond the proximal segment a distance of approximately 25 cm.

[0250] In one aspect of the present disclosure, the distal opening is movable in response to movement of the control wire. In another aspect of the disclosure, the distal opening changes between a smaller configuration and a smaller configuration in response to application of a vacuum to the lumen. In yet another aspect of the present disclosure, the distal opening is movable between a larger configuration and a smaller configuration. The size is changed by lateral movement of the sidewall of the distal section. In yet another aspect of the present disclosure, the distal opening includes at least one movable jaw. The distal section of the distal portion includes a duck bill valve configuration.

[0251] In one aspect of the present disclosure, the telescopic catheter includes a control that applies an intermittent vacuum to the lumen. The controller may further include a pressure sensor for detecting the pressure of the pipes separated by a neutral pressure space. The controller may be configured to apply a pulse of vacuum to the cavity. The catheter may be configured to apply alternating pulses of high pressure and pulses of lower negative pressure. The distal tip of the probe may reciprocate axially in response to application of a vacuum pulse to the lumen.

[0252] According to one embodiment, an elongated flexible tubular body having a longitudinal length extending therethrough. a tubular body including at least one central lumen through which the agitator passes; a stirrer that is extendable and retractable so that a distal end of the stirrer is disposed near a distal end of the tubular body; a driver connectable to a proximal end of the agitator and configured to actuate the agitator; a vacuum port near the proximal end of the tubular body and in fluid communication with the central lumen of the tubular body. A system is provided for aspirating vascular occlusions from a remote site.

[0253] In one aspect of the present disclosure, the agitator comprises an elongated tube. The agitator may comprise a wire. The wire extends through the elongated tube and has at least one bend near its distal end. In another aspect of the present disclosure, the stirring body has a proximal end, a distal end, and a distal end. In yet another aspect of the present disclosure, the drive device drives the agitator in an alternating manner. The optical axis is configured to rotate periodically in a direction.

[0254] In one aspect of the present disclosure, the agitator body has at least one lumen along its longitudinal length. and a proximal portion thereof configured to enable flow communication between the lumen of the agitator body and the source of medium. Allowing flow communication between the inlet ports near the ends and the lumen of the agitator and the central lumen of the tubular body and at least one outflow port configured to aspirate the vascular obstruction. The system further includes a control device for expressing a medium from an outlet port of the agitator body into a central lumen of the tubular body. The distal portion of the tubular body may be adapted to vibrate transversely in response to injection of a medium. The present invention may be configured as follows.

[0255] In one aspect of the present disclosure, a system for aspirating vascular obstruction includes a central lumen having a pulsed vacuum source. In another aspect of the present disclosure, the present invention further includes a controller for applying a suction to the blood vessel obstruction. The system further includes a rotating hemostatic valve coupled to the proximal end of the tubular body, the rotating hemostatic valve comprising: At least one main lumen along its longitudinal length through which the agitator body passes A main lumen through which the proximal portion passes, and a suction lumen branching from the main lumen and having a vacuum port. In yet another aspect of the present disclosure, the system includes a catheter coupled to a proximal end of the tubular body. The proximal drive assembly further comprises: a proximal drive assembly for receiving the agitator; at least one main lumen along a longitudinal length; a central lumen of the tubular body through which a medium is injected; a proximal media inlet port in fluid communication with the agitator and operably connected between the agitator and the driver; and a proximal drive connection at the end.

[0256] In accordance with another aspect, a method of aspirating vascular occlusion from a remote site is provided, comprising: providing a system for pulling the tubular body adjacent to the obstruction; and a drive mechanism. and applying a vacuum to the central lumen to remove the obstruction. and drawing the material into a central lumen. In one aspect of the present disclosure, a system for aspirating vascular obstruction is provided, comprising: placing the body adjacent to the obstruction; and actuating the drive to rotate the distal tip of the agitator. injecting a medium through the injection port; and applying a vacuum to the central lumen to create an occlusive and aspirating the material into a central lumen. The actuation of the drive, suction, and medium injection are performed to remove obstructions and / or aspiration. may be synchronized to facilitate

[0257] In one aspect of the disclosure, a method for aspirating vascular occlusion from a remote site comprises the steps of: and advancing the guidewire distal to at least the cavernous segment of the internal carotid artery; advancing the tubular body directly through the tubular body to a distal location at least to the cancellous segment; removing the guidewire from the tubular body; and removing the thrombus from the tubular body by applying a vacuum to the tubular body. and aspirating a vascular occlusion from a remote site, the method comprising: aspirating the vascular occlusion into a vascular occlusion body. In one aspect of the present disclosure, the method of aspirating a vascular occlusion includes: inserting a tubular body into at least a large portion of the internal carotid artery. In another aspect of the present disclosure, the method includes aspirating the vascular occlusion. The method includes advancing a guidewire at least as distal as the middle cerebral artery.

[0258] In yet another aspect of the present disclosure, a method for aspirating a vascular occlusion includes aspirating a prolapsed tubular body into an aorta. The present invention further includes providing sufficient back-up support for the tubular body to resist the In this study, the backup support was positioned distally at least to the cancellous segment of the internal carotid artery. a guidewire having a distal end and a diameter at the point where it enters the brachiocephalic artery of at least about By advancing the tubular body over a guidewire that is 0.030 inches In another aspect, the backup support may be at least the cancellous section of the internal carotid artery. a guidewire having a distal end positioned distally at a point where it enters the brachiocephalic artery; and advancing the tubular body over a guidewire having a diameter of about 0.038 inches at . The guidewire may have a diameter not exceeding about 0.020 inches. By having a distal segment that can be used to navigate to at least the cerebral division of the internal carotid artery, The guidewire may have a distal section having a diameter of about 0.016 inches. By using a cerebrovascular procedure, it may be possible to navigate at least the cerebral division of the internal carotid artery. The distal section may have a length not exceeding about 25 cm. The distal section may have a length not exceeding about 20 cm. It may have a long length.

[0259] According to another embodiment, the femoral access site is at least as distant as the cerebral division of the internal carotid artery. advancing the guidewire to a position where the guidewire is at least about 0. A proximal section having a diameter of 0.030 inches and a length of 25 cm or less and a length of at least about 0.0 a distal section having a diameter of 20 inches; and following the suction catheter directly distally to at least the cancellous section. Thus, the suction catheter has a distal end, a diameter of at least about 0.080 inches, and a tapered and a central lumen at the distal end having a distal tip. The aspiration catheter was traced from the insertion site to a point at least as distal as the cavernous division of the internal carotid artery. In one aspect of the present disclosure, a method is provided in which the diameter of the proximal section of the guidewire is about 0.03 mm. 8 inches and the diameter of the distal section is approximately 0.016 inches.

[0260] In another aspect of the disclosure, the distal section of the catheter includes a sidewall defining a central lumen, The wall is made up of: a tubular inner liner; a soft bonding layer separated from the lumen by the inner liner; A helical coil surrounding the bundle layer, adjacent turns of the coil being spaced apart gradually in a distal direction. a coil surrounding the helical coil and positioned coaxially around the coil; An outer jacket formed from a plurality of tubular sections; The distal portion of the tubular section has a durometer of about 35D or less. and an outer jacket having a meter. The tubular liner includes a removable mandrel. It may be formed by dip coating and may include PTFE. The layer may include polyurethane. The tie layer has a wall thickness of about 0.005 inches or less. and may extend along at least the distal most 20 cm of the flexible body. It may also include a shape memory material.

[0261] In accordance with one aspect, a neurovascular catheter having enhanced flexibility is provided, the tel includes an elongated flexible body having a proximal end, a distal end, and a sidewall defining a central lumen; The distal zone of the sidewall is made up of a tubular inner liner and a soft inner liner separated from the lumen by the inner liner. a helical coil surrounding the bonding layer, the adjacent turns of the coil being in a distal direction; and a coil spaced progressively further apart in the direction of the helical coil; surrounding the helical coil and an outer jacket formed from a plurality of tubular sections positioned coaxially about the outer jacket; The proximal portion of the tubular section has a durometer of at least about 60D and the distal portion of the tubular section has a durometer of at least about 60D. and an outer jacket having a durometer of about 35D or less. The tubular liner is formed by dip coating a removable mandrel. In another embodiment of the disclosure, the tubular liner comprises PTFE.

[0262] In yet another aspect of the present disclosure, the tie layer comprises polyurethane. The flexible body may have a wall thickness of up to 20 inches and extend along at least the distal most 20 cm of the flexible body. In one aspect of the present disclosure, the coil comprises a shape memory material. The nitinol may be in an austenitic state at body temperature.

[0263] In one embodiment of the present disclosure, the outer jacket is formed from at least five individual tubular sections. The outer jacket may be formed from at least nine individual tubular sections. The difference in durometer between the proximal and distal tubular sections is at least about 2 The durometer between the proximal and distal tubular sections may be 0D. The difference in data may be at least about 30D.

[0264] In another aspect of the present disclosure, a neurovascular catheter with enhanced flexibility comprises a distal zone The filament further includes a tension support for increasing the tension resistance of the filament. The axially extending filaments may be included, or may include axially extending filaments. The filaments may be supported between the inner liner and the helical coil. The filaments have a tensile strength of at least about 1 lb., at least about 2 lbs., at least about 100 lbs. About 3 pounds, at least about 4 pounds, at least about 5 pounds, at least about 6 pounds, a little at least about 7 pounds, at least about 8 pounds, or at least about 10 pounds, or It may be increased even more than that.

[0265] In accordance with one aspect, a neurovascular catheter having enhanced flexibility is provided, the neurovascular catheter comprising: The catheter has an elongated flexible body having a proximal end, a distal end, and a sidewall defining a central lumen. a distal zone of the side wall surrounding the helical coil and positioned coaxially about the coil; an outer jacket formed from a plurality of tubular sections; , having a durometer of at least about 60D, and the distal one of the tubular sections having a durometer of no more than about 35D. an outer jacket having a durometer of about 10 at least at the most distal portion of the catheter length; and an axially extending filament within the sidewall, the filament extending about 1 cm. The filament may extend for at least about the distal most 15 cm of the length of the catheter. The filaments may extend for at least about the distal most 20 cm of the length of the catheter. The fibers may extend axially between the coil and the inner liner.

[0266] In one aspect of the present disclosure, the sidewall comprises: a tubular inner liner; and a lumen separated by the inner liner. a soft bonding layer; and a helical coil surrounding the bonding layer and adjacent the coil. The adjacent windings are spaced progressively further apart in the distal direction. The tubular liner is The support may be formed by dip coating the support and may comprise PTFE. The tie layer may include polyurethane and have a wall thickness of about 0.005 inches or less. The tie layer may extend along at least the distal-most 20 cm of the flexible body. The coil may include a shape memory material and may include Nitinol. Tinol may contain an austenitic state at body temperature.

[0267] In one embodiment of the present disclosure, the outer jacket is formed from at least five individual tubular sections. In another embodiment of the present disclosure, the outer jacket may be formed of at least nine individual tubular sections. The durometer may be formed from a durometer between the proximal and distal tubular sections. The difference in meters may be at least about 20D. The difference in durometer between the distal one and the distal one may be at least about 30D. In another embodiment, the catheter is capable of withstanding at least about 3.5 pounds of tension before failure. In yet another embodiment, the catheter can withstand at least about 5 pounds of tension before failure. can withstand.

[0268] In one aspect of the present disclosure, a method for forming a highly flexible distal zone on a neurovascular catheter is provided. The method includes dip-coating a removable mandrel to form a tubular inner layer on the mandrel. forming a tubular inner layer; and coating the tubular inner layer with a soft binding layer; applying a helical coil; and positioning a plurality of tubular sections over the helical coil. wherein the plurality of segments have a durometer that decreases in a distal direction. and; heating the tubular section to form a highly flexible distal zone on the neurovascular catheter. and removing the mandrel. In one aspect of the present disclosure, removing the mandrel In another aspect of the present disclosure, the step of extending the mandrel in an axial direction includes: Methods for creating a highly flexible distal zone on a neurovascular catheter include at least one on a helical coil. In yet another embodiment of the present disclosure, the neurovascular catheter includes positioning all seven segments. The method for producing a highly flexible distal zone on a catheter comprises forming at least nine sections on a helical coil. This includes positioning the minutes.

[0269] In one aspect of the present disclosure, a discontinuity between a proximal tubular section and a distal tubular segment is provided. The difference in durometer is at least about 20D. The difference in durometer between the distal one and the distal one may be at least about 30D. The layer may comprise PTFE. In another aspect of the present disclosure, the tie layer comprises polyurethane. The tie layer may have a wall thickness of about 0.005 inches or less. It may extend along at least the distal most 20 cm.

[0270] In one aspect of the present disclosure, the coil comprises a shape memory material. The coil comprises Nitinol. Nitinol may include an austenitic state at body temperature. In one embodiment, a method for creating a highly flexible distal zone on a neurovascular catheter includes heat treating a tubular section. Prior to contracting, at least one tensile strength enhancing fibril is disposed between the coil and the tie layer. The method further includes the step of positioning the filament along the length of the catheter. The filament may extend along at least about the distal most 15 cm of the length of the catheter. The filament may extend along at least about 20 cm of the distal-most portion of the length of the fiber. In yet another aspect of the present disclosure, a highly flexible distal end is provided on the neurovascular catheter. The method of forming the position zone includes at least one step before applying the helical coil step. The method further includes the step of positioning a tensile strength enhancing filament on the tie layer.

[0271] In one aspect, a method of aspirating vascular obstruction from a remote site is provided, the method comprising: Advancing the tubular body through the vascular access site and into the body lumen, the tubular body comprising: a proximal end, a distal end, and a central lumen; and and applying a vacuum to the lumen to draw the thrombus into the lumen. and mechanically disrupting the thrombus to facilitate its entry into the lumen. nothing.

[0272] In one aspect of the present disclosure, the mechanically disrupting step includes introducing vibrations to the distal end of the tubular body. The vibration may be introduced by rotating a stirrer within the tubular body. The method of aspirating the obstruction may include rotating a wire within the tubular body. The method of aspirating the obstruction may include rotating a tube within the tubular body, and The method of aspirating a vascular obstruction may further include introducing a medium through the The method may include introducing a lubricant into the tube to advance the thrombus through the lumen. and introducing polyethylene glycol into the tube.

[0273] In another aspect of the disclosure, the step of applying a vacuum comprises applying a pulsed vacuum. In yet another aspect of the present disclosure, the step of advancing the elongate tubular body includes The method of aspirating the vascular occlusion is accomplished directly over the guidewire without the need for a catheter. The method may further include advancing the catheter distally to at least the cavernous segment of the internal carotid artery. The method of aspirating the vascular occlusion involves advancing the tubular body distally to at least the cerebral division of the internal carotid artery. The method for aspirating a vascular obstruction may include at least one guidewire. The method may also include advancing the catheter distally to the middle cerebral artery.

[0274] In one aspect of the present disclosure, the method of aspirating a vascular occlusion includes: The method further includes providing sufficient back-up support for the tubular body to support the tubular body. The support comprises a guide having a distal end positioned distal to at least the cancellous portion of the internal carotid artery. Dwyer, with a diameter of at least about 0.030 inches at the point where it enters the brachiocephalic artery By advancing the tubular body over a guidewire, The backup support should be positioned distally at least to the cancellous segment of the same internal carotid artery. a guidewire having a distal end that is approximately 0.05 mm in diameter when it enters the brachiocephalic artery; The tubular body is advanced over a guidewire measuring 0.038 inches. may be provided to

[0275] In one embodiment of the present disclosure, the guidewire has a distal section having a diameter of about 0.020 inches or less. By having a guidewire, it is possible to navigate to at least the cerebral division of the internal carotid artery. Dwyer has a distal section with a diameter of about 0.016 inches to reduce the risk of internal carotid arthritis. In some cases, the method may be capable of navigating to at least a cerebral division of the ventricle. The method for aspirating a blood vessel obstruction includes, following the positioning step, introducing an agitator into the tubular body. The method further includes the step of: a proximal section of the agitator may extend through a tube of the restraining device; The distal section of the agitator may extend beyond the distal end of the restraint device tube.

[0276] In accordance with one aspect of the present disclosure, a method is provided for aspirating vascular occlusion from a remote site, the method comprising: The method involves: vascular access to a site distal to at least the cavernous portion of the internal carotid artery. and advancing a guidewire directly over the guidewire to access and The suction combination catheter is advanced to achieve distal suction at least to the cancellous segment. Accessing the site; Removing the guidewire; Access and aspiration catheters and aspirating the thrombus through the catheter. The method involves inserting a combination access and aspiration catheter into the cerebral division of the internal carotid artery and into the In another aspect of the present disclosure, the method of aspirating vascular obstruction includes advancing the catheter distally to the same location. The method includes advancing a guidewire distally to at least the middle cerebral artery.

[0277] In yet another aspect of the present disclosure, a method for aspirating a vascular obstruction includes inserting a catheter into the aorta. The combination access and suction catheter must have sufficient back-up to resist prolapse. The back-up support may be provided to the access and suction combination. To deliver the aligned catheter, position it distally at least to the cavernous segment of the internal carotid artery. a guidewire having a distal end that is narrowed in diameter at the point where it enters the brachiocephalic artery; The combined access and aspiration is performed over a guidewire that is approximately 0.030 inches long. Backup support may be used as a combination of access and aspiration. To provide the catheter with a catheter, it must be positioned distally at least to the cavernous portion of the internal carotid artery. a guidewire having a distal end with a diameter of about 0.03 mm at the point where it enters the brachiocephalic artery; A combined access and aspiration catheter was placed over an 8-inch guidewire. Move the rule forward.

[0278] In one embodiment of the present disclosure, the guidewire has a distal section having a diameter of about 0.020 inches or less. By having a guidewire, it is possible to navigate to at least the cerebral division of the internal carotid artery. Dwyer has a distal section with a diameter of about 0.016 inches to reduce the risk of internal carotid arthritis. In some cases, it may be possible to navigate to at least the cerebral division of the ventricle. The diameter may be about 0.038 inches, and the distal section may have a diameter of about 0.016 inches. may be also possible.

[0279] In another aspect of the present disclosure, the distal section of the combination access and aspiration catheter comprises The sidewall defines a central lumen, the sidewall having a tubular inner liner; a bonding layer separated from the coil; and a helical coil surrounding the bonding layer, the adjacent turns of the coil being spaced apart from each other. a coil in which the wires are spaced progressively further apart in the distal direction; and a coil surrounding the helical coil. an outer jacket formed from a plurality of tubular sections positioned coaxially around the a proximal one of the tubular sections having a durometer of at least about 60D; a distal one of the outer jacket having a durometer of at least about 35D or less; The tubular liner is formed by dip coating a removable mandrel. The tubular liner may include PTFE. The tie layer may be constructed of polyurethane. The tie layer may be 0.01 to 0.5 mm thick and may have a wall thickness of about 0.005 inches or less. It may extend along at least the distal-most 20cm of the flexure.

[0280] In one aspect of the present disclosure, the coil may include a shape memory material. So, the method of aspirating vascular obstruction is to use a combination of access and aspiration catheters. The method of aspirating vascular obstruction further includes introducing a body into the vascular obstruction. The method may further include vibrating the distal portion of the body. During the aspirating step, the method may further include introducing a fluid medium through the agitator. The method for aspirating vascular obstruction includes, during the aspirating step, introducing polyethylene glycol through the agitator. The method may further include introducing a

[0281] In one aspect, an elongated flexible tube having a proximal end, a distal end, and a sidewall defining a central lumen. A neurovascular catheter is provided that includes a tubular body and a distal zone of the tubular body including: a tubular inner liner; a bundling layer separated from the lumen by an inner liner; and a helical coil surrounding the bundling layer. a coil in which adjacent windings of the coil are spaced progressively further apart in a distal direction; An outer jacket surrounding the helical coil; and a first inner diameter for transluminal navigation. to a second, larger inner diameter to facilitate aspiration of the thrombus into the lumen. and an opening at a distal end. In one aspect of the present disclosure, the distal opening is adapted to expand in response to exposure to blood. In another aspect of the present disclosure, the distal opening is expandable in response to exposure to body heat. In yet another aspect of the present disclosure, the distal opening can be expanded in response to removal of the restraining device. The restraining device comprises a polymer that has reduced structural integrity in the intravascular environment. It's okay to do that.

[0282] In one aspect of the present disclosure, the catheter body adjacent the distal opening is radially outwardly biased. The catheter body adjacent the distal opening includes an embedded Nitinol support. The support may comprise a wire mesh. The body may include a stent. In another aspect of the present disclosure, a catheter adjacent the distal opening is In yet another aspect of the present disclosure, the tubular liner comprises a hydrophilic blend. The tubular liner is formed by dip coating a removable mandrel. may also include

[0283] In one embodiment of the present disclosure, the tie layer comprises polyurethane. The tie layer may extend along at least the distal most 20 cm of the flexible body. In another aspect of the present disclosure, the coil comprises a shape memory material. Nitinol may include an austenitic state at body temperature. In one embodiment of the present disclosure, the outer jacket is formed from at least five individual tubular sections. The outer jacket may be formed from at least nine individual tubular sections. The difference in durometer between the proximal and distal portions of the tubular segment is at least The distance between the proximal tubular section and the distal tubular section may be about 20D. The difference in diameter may be at least about 30D.

[0284] In accordance with one aspect of the present disclosure, a control wire is provided having a proximal end and a distal end. a tubular extension having side walls defining a central lumen supported by the distal end of the control wire; and a sidewall of the extension section of the neurovascular catheter, the sidewall comprising: a tubular inner liner; a bundling layer separated from the lumen by an inner liner; and a helical coil surrounding the bundling layer. and an outer jacket surrounding the helical coil. The coil is formed from a plurality of tubular sections positioned coaxially around the coil. The proximal portion may have a durometer of at least about 60D and may be tubular. The distal one of the segments may have a durometer of about 35D or less.

[0285] In another aspect of the present disclosure, the tubular liner is formed by dip coating a removable mandrel. The tubular liner may comprise PTFE. In an embodiment, the tie layer comprises polyurethane. The tie layer has a wall thickness of about 0.005 inches or less. The tie layer may extend along at least the distal most 20 cm of the tubular extension section. In one aspect of the present disclosure, the coil comprises a shape memory material. Nitinol may include an austenitic state at body temperature.

[0286] In one embodiment of the present disclosure, the outer jacket is formed from at least five individual tubular sections. The outer jacket may be formed from at least nine individual tubular sections. The difference in durometer between the proximal and distal tubular sections is at least about 2 The durometer between the proximal and distal tubular sections may be 0D. In another embodiment of the present disclosure, the control wires may have a difference of at least about 30D. The central lumen of the control wire may be in communication with the central lumen of the tubular extension section. In yet another aspect of the present disclosure, the inner diameter of the neurovascular catheter extension section is The inner diameter of the neurovascular catheter extension section is at least twice the inner diameter of the central lumen. It may be at least three times the inner diameter of the central ear lumen.

[0287] In accordance with another aspect, the neurovascular catheter extension section and the central lumen of the control wire are and a stirrer configured to extend through the neurovascular catheter into a central lumen of the tubular extension section. A catheter extension section system is provided.

[0288] The present invention has been described with respect to certain preferred embodiments, which are within the scope of the disclosure herein. In view of the above, those skilled in the art may incorporate the above into other embodiments. The scope of the present invention is not intended to be limited by the specific embodiments disclosed herein. It is intended that the full scope of the present invention be defined by the following claims, rather than by the full scope of the claims.

Claims

1. 1. A system for removing embolic material from an intravascular site, comprising: a proximal end, a distal end, and a tubular sidewall extending axially therethrough; an elongated, flexible tubular body having a tubular sidewall defining a lumen; an axial restraint device supported by the sidewall and exposed to the lumen; a core wire extending through the lumen and having a proximal end and a distal end; a bearing surface supported by the core wire and rotatably engaging the restraining device; A limiting device for restricting the movement of the a stirrer tip on the distal end of the core wire; The limiting device and the restraining device permit rotation of the core wire but not of the tubular body. and a distal end portion engageable with said distal end to limit distal advancement of said tip relative to said distal end portion.

2. The system of claim 1 , wherein the axial restraint device includes a proximally facing bearing surface.

3. 3. The system of claim 2, wherein the axial restraint device includes a radially inwardly extending protrusion. Hmm.

4. The system of claim 3 , wherein the axial restraint device comprises an annular flange.

5. The system of claim 1 , wherein the restriction device includes a distally facing bearing surface.

6. The system of claim 5 , wherein the restriction device includes a radially outwardly extending protrusion.

7. The radially outwardly extending protrusion is configured to be in sliding contact with an inner surface of the tubular sidewall.

7. The system of claim 6, further comprising spokes supporting the slides.

8. The system of claim 7 including three spokes supporting each of the slides.

9. The system of claim 6 , wherein the restriction device comprises an annular ring.

10. 2. The method of claim 1, wherein the restriction device includes an annular ring spaced radially outward from the core wire. Item 2. The system described in item 1.

11. and at least two spokes extending between said core wire and said ring. The system of claim 10.

12. 12. The method of claim 11 including three spokes extending between the core wire and the ring. system.

13. a flow passage defined between each adjacent pair of spokes and in communication with said central lumen. The system of claim 8 .

14. The device includes three flow paths, the sum of the cross-sectional areas of the three flow paths being within a proximal 1 cm area of ​​the restraint device. The system of claim 13 , wherein the periphery is at least about 75% of the cross-sectional area of ​​the lumen.

15. The sum of the cross-sectional areas of the three flow paths is the cross-sectional area of ​​the lumen within 1 cm proximal to the restraint device. The system of claim 14 , wherein the area is at least about 90%.

16. The core wire is adapted to change from a larger diameter at the proximal point to a larger diameter at the restriction device.

2. The cylinder of claim 1, which tapers to a smaller diameter that is no more than about 30% of the diameter of the cylinder. Stem.

17. The core wire has a minor diameter that is about 18% or less than the major diameter of the restriction device. The system of claim 16 , wherein the diameter tapers.

18. The core wire may be configured to change from a diameter of about 0.025 inches at the proximal point to a diameter of about 0.5 inches at the restriction device.

20. The system of claim 17, tapered to a diameter of 0.005 inches or less.

19. The system of claim 1 , wherein the tip of the agitator includes a helical thread.

20. The helical thread has an outer thread diameter that is about 90% or less of the inner diameter of the lumen, and the tip 20. The system of claim 19, further comprising: a recess for recessing said first and second recesses for retaining said first and second recesses;

21. The core wire is supported by the core wire and has a length ranging from about 5 cm to about 60 cm. The system of claim 16 , further comprising a spring extending proximally from the tip.

22. The spring extends proximally from the tip by a length ranging from about 20 cm to about 40 cm.

22. The system of claim 21 .

23. 20. The system of claim 19, wherein the helical thread has a blunt outer edge.

24. 2. The catheter of claim 1, wherein the restriction device is located within the distal portion of the catheter. Item 2. The system described in item 1.

25. 2. The catheter of claim 1, wherein the restriction device is located within the distal portion of the catheter.

25. The system described in item 24.

26. 2. The method of claim 1, wherein the core wire is removably positionable within the tubular body. The system described in

27. The helical threads define helical flow paths between axially adjacent threads, The sum of the cross-sectional area of ​​the conical passage and the cross-sectional area of ​​the annular passage is at least about 20% of the cross-sectional area of ​​the lumen.

21. The system of claim 20, wherein the ratio of the number of

28. The bearing surface adjusts the agitation pressure in response to positioning of the tubular body within a tortuous vasculature.

26. The system of claim 25, further comprising: a distal end portion that is adapted to be coupled to said distal end of said distal end portion;

29. 1. A method for removing embolic material from a blood vessel using mechanical and suction assistance, comprising: Providing an aspiration catheter having a central lumen and a distal end; advancing the distal end to occlusive material within a blood vessel; rotating the tip within the lumen, the tip extending from about 5 mm or less an axial length and an outer diameter at least about 0.015 inches less than the inner diameter of said lumen; providing a suction passage around an exterior of the tip, the suction passage having a helical thread; applying a vacuum to the lumen and rotating the tip to draw material into the lumen. and, A method comprising:

30. The rotating step includes manually rotating a core wire extending through the catheter.

30. The method of claim 29, comprising: rotating the tip.

31. A restraining device is positioned within the central lumen and supported by the core wire. and limiting distal advancement of the core wire by rotating a limiting device disposed in the distal end of the core wire.

31. The method of claim 30, further comprising:

32. 1. A method for aspirating a vascular obstruction from a remote site, comprising: advancing an elongated tubular body through a vascular access site to a vascular occlusion; the tubular body having a proximal end, a distal end, a central lumen, and a lumen extending from the tubular body into the lumen. a stopping device; A limiting device supported by the rotatable core wire is connected to the stop device. and advancing the distal end of the catheter through the lumen until the catheter slides into engagement with the distal end of the catheter. providing a rotatable bearing to limit further distal advancement of the core wire at and, A vacuum is applied to the lumen and the core wire is rotated to draw the thrombus into the lumen. Steps and 4. A method of aspirating vascular obstruction from a remote site, comprising:

33. 33. The method of claim 32, wherein the step of applying a vacuum comprises applying a pulsed vacuum. A method for aspirating a vascular obstruction as described above.

34. The step of advancing the elongated tubular body includes a guide without any interposition of the tubular body.

33. The method of aspirating a vascular obstruction as claimed in claim 32, wherein the aspirating is accomplished directly across the wire.

35. and advancing the tubular body distally to at least the cancellous portion of the internal carotid artery. The method for aspirating a vascular obstruction as described in claim 32.

36. and advancing the tubular body distally to at least the cerebral division of the internal carotid artery.

33. A method for aspirating vascular obstruction as described in 32.

37. The step of advancing the rotatable core wire includes advancing an elongate tubular body to a vascular access site.

33. The method of claim 32, wherein the step of advancing the catheter through the catheter to the vascular obstruction is performed after the step of advancing the catheter through the catheter to the vascular obstruction. How to aspirate duct obstructions.

38. The step of advancing the rotatable core wire extends the elongate tubular body through a vascular access 33. The method of claim 32, wherein the step of advancing the catheter through the catheter site to the vascular occlusion is accomplished simultaneously. A method for aspirating a vascular obstruction as described above.

39. 1. A neurovascular catheter having an atraumatic navigation tip, comprising: The device includes an elongated, flexible, tubular body having a proximal end, a distal end, and a sidewall defining a central lumen. , the distal zone of the tubular body is a tubular inner liner; a helical coil surrounding the inner liner and having a distal end; encircling the helical coil and extending distally beyond the distal end of the helical coil; a tubular jacket terminating at a distal surface of the catheter; a tubular member embedded within the tubular jacket between the distal end of the coil and the distal face; a radiopaque marker; The distal surface intersects with the longitudinal axis of the tubular body at an angle within a range of about 35 degrees to about 55 degrees. exists on a transverse plane, The marker has a proximal surface that is generally perpendicular to the longitudinal axis and an angle between about 35 degrees and about 55 degrees. and a distal surface lying on a plane intersecting the longitudinal axis at an angle within the range of 0.01 mm to 0.1 mm. Tube catheter.

40. The distal surface defines a leading edge of the tubular body extending distally from a trailing edge of the tubular body, 40. The method of claim 39, wherein the edge and the trailing edge are spaced about 180 degrees from each other about the longitudinal axis. Neurovascular catheter.

41. 41. The method of claim 40, wherein the advancement section of the tubular body extends distally beyond the marker band. Transvascular catheter.

42. The forward moving section is axially extending within a range of about 1 mm to about 3 mm from the leading edge of the tubular body.

42. The neurovascular catheter of claim 41 having a diagonal length.

43. The length of the forward moving section of the tubular body on the leading edge side is greater than the length of the forward moving section of the tubular body on the trailing edge side.

41. The neurovascular catheter of claim 40, wherein the length is greater than

44. The axial length of the marker band on the leading edge side of the tubular body is 41. The neurovascular catheter of claim 40, wherein the length of the catheter is at least about 20% longer than the axial length of the band. 。

45. The axial length of the leading edge marker band of the tubular body is in the range of about 1 mm to about 5 mm.

45. The neurovascular catheter of claim 44,

46. 41. The neurovascular device of claim 40, wherein the marker band includes at least one axial slit. Tube catheter.

47. The tubular liner is formed by dip coating a removable mandrel.

41. The neurovascular catheter of claim 40.

48. 48. The neurovascular catheter of claim 47, wherein the tubular liner comprises PTFE.

49. 41. The coil of claim 40, further comprising a tie layer between the inner liner and the helical coil. Neurovascular catheter.

50. 50. The neurovascular catheter of claim 49, wherein the bonding layer has a wall thickness of about 0.005 inches or less. Thetell.

51. 51. The method of claim 50, wherein the tie layer extends along at least a distal-most 20 cm of the flexible body.

2. A neurovascular catheter according to claim 1 .

52. 41. The neurovascular catheter of claim 40, wherein the coil comprises Nitinol. Tell me.

53. 4. The method of claim 1, wherein the Nitinol comprises an austenite state at body temperature.

53. A neurovascular catheter as described in 52.

54. The outer jacket is formed from at least five axially adjacent discrete tubular sections.

40. The neurovascular catheter of claim 39.

55. the outer jacket being formed from at least nine axially adjacent discrete tubular sections; 55. The neurovascular catheter of claim 54.

56. the difference in durometer between the proximal and distal tubular sections is:

55. The neurovascular catheter of claim 54, which is at least about 20D.

57. the difference in durometer between the proximal and distal tubular sections is:

57. The neurovascular catheter of claim 56, which is at least about 30D.

58. 41. The method of claim 40, further comprising: providing a tension support to increase tension resistance in the distal zone. Neurovascular catheter.

59. 59. The flexible tension support of claim 58, wherein the tension support comprises an axially extending filament. Reinforced neurovascular catheter.

60. The axially extending filament is supported between the inner liner and the helical coil.

60. The neurovascular catheter of claim 59.

61. The axially extending filaments provide the tubular body with a tensile strength of at least about 2 pounds.

60. The neurovascular catheter of claim 59, wherein the neurovascular catheter is increased by

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