JP2016510680A - Devices and methods for treating chronic total occlusion - Google Patents

Abstract

Devices and methods for releasing vascular obstructions such as chronic total occlusions are disclosed. The device has a perforation unit and a stationary unit having a plurality of curved alignment structures along its outer edge to support the inner surface of the vessel wall. A torque transmission member (drive shaft) is arranged in the stationary unit and extends into the rotary drilling unit. A curved alignment structure along the outer surface of the device helps align the device to the center within the vessel, thereby preventing the device from deflecting and penetrating the vessel wall. The piercing unit has a plurality of loops on its distal tip located in the distal region of the piercing unit. These loops disrupt the occlusion as the device is advanced and rotated through the blood vessel.

Description

(Citation of related application)
This application claims the benefit of US patent application Ser. No. 14/080970 filed Nov. 15, 2013, which is filed on Mar. 13, 2013. 13 / 801,228, each of which is a continuation-in-part application, each of which is incorporated herein by reference in its entirety.

  The present invention relates generally to devices and methods for reopening a blood vessel, and more specifically, devices and methods for aligning a vascular perforator to the center of a blood vessel to disrupt and open a chronic total occlusion. About.

  Chronic total occlusion (CTO) is a fully occluded vascular lesion. These can occur anywhere in the human body such as coronary arteriovenous, jugular arteriovenous, internal arteriovenous, ileal arteriovenous, femoral arteriovenous, and popliteal arteriovenous. Usually these lesions will occur over months to years. Due to its chronic nature, there will usually be an adequate amount of time for the development of side branch vessels to supply blood to the tissue. However, these side branch vessels cannot provide sufficient blood flow to keep the end organs alive and are inadequate to support the function of the dependent organs.

  Chronic total occlusion can have serious medical consequences depending on the location. For example, obstructions located in the coronary arteries can cause myocardial damage and heart failure, while obstructions located in the femoral and popliteal arteries can cause leg ulcers and gangrene.

  Chronic total occlusion itself is not “total occlusion”, but rather contains several essentially dysfunctional narrow channels. Conventionally, hydrophilic coated guidewires have been used and pierced through one or more of these narrow channels to provide a continuous path between the proximal open vascular compartment and the distal occlusion. Generate. The passage is subsequently inflated to accommodate a therapeutic device such as a balloon or stent.

  Various surgical procedures and minimally invasive methods have been the mainstream for revascularization of CTO for many years. Surgical grafts have been designed for decades to bypass obstructions in the coronary or peripheral vessels. Minimally invasive techniques include guidewires or CTO devices.

  CTO lesions often contain very hard and calcified plaques, making them impermeable. Guidewires are sometimes dangerous because they can inadvertently damage or even pierce the vessel wall when used in a CTO. In many cases, the guidewire tip has insufficient support and can buckle during attempts to penetrate into the calcified plaque. The guidewire, when pushed into the CTO, is also inadvertently misoriented in an unintended direction by the operator, creating a dead end surface (ie, the intimal lower surface) between the vessel wall and the plaque. obtain. If the guidewire cannot create a normal passage through the CTO, the resulting subintimal tract prevents the use of subsequent treatment devices such as balloons, stents, or atherectomy catheters. Another disadvantage of CTO devices is the shaft that is not robust enough to resist twisting when advanced inside the CTO. Yet another disadvantage is that the CTO device is not easily controlled, so that the tip of the CTO device is deflected eccentrically from the center of the blood vessel when the CTO device is pushed through the CTO. Due to these disadvantages, the success rate for guidewires in CTO revascularization is not very high.

  Several CTO techniques have been introduced in an attempt to overcome some of the difficulties faced when using guidewires and CTO devices, improving the success rate of CTO penetration. In US Pat. No. 6,599,304, Selmon et al “intravascular catheter system for treatment of occluded blood vessels, including tissue displacement or hinged expansion members movable from a closed position to an open position. A diffusion or mechanical force may thus be applied to the vessel wall and occlusion so as to rupture, break or otherwise destroy the occlusion adjacent to the vessel wall. As a part of the overall attempt to restore normal circulatory function surrounding a closed blood vessel region, a channel of sufficient size for passage of a guide wire or therapeutic catheter around or through at least a portion of an obstruction A passage can be created ".

  In US Pat. No. 8,062,316, Patel et al. Teach a CTO catheter with a spiral blade at its distal end and a novel rotating cutting head whose tip is placed within a protective sheath. “The application of torque to the inner catheter or wire attached to the cutting head applies a spin to the cutting head. Depending on the angle and nature of the protruding blade of the cutting head, the blade may actually be a body lumen. Can be designed to simply cut through the occlusive material without removing the occlusive material from, or alternatively, the blade cuts through the occlusive material and also cuts the seam to the body lumen, thereby Can be designed to be removed from the body lumen. "

  In US patent application Ser. No. 11 / 090,435, Hong teaches a system for opening a CTO by using a catheter having multiple channels. In addition, the catheter may have a bullet-shaped distal tip and / or torque groove in the proximal and distal shafts to facilitate manual advancement of the catheter through the CTO using manual torque action at the proximal end. Will do. Multiple channels extending along the length of the catheter can be expanded and used to advance a guidewire, balloon, or stent into the lesion.

  In U.S. Pat. No. 8,021,330, McAndrew states, “At its distal end is a guidewire shaft having a flexible shaft or a distal portion of a tubular section for selectively grasping a guidewire therein. A new balloon catheter is taught, with an “enclosed, wrinkle-free balloon”. In response to expansion, the flexible soft section of the guidewire shaft locks onto the guidewire. “This provides the clinician with a combined balloon catheter and guidewire assembly that can be pushed together through a tight stenosis such as a chronic total occlusion.”

  In US patent application Ser. No. 12 / 108,921, Duffy et al. Teaches a visualization and treatment system for treating CTO. The system includes an elongate member configured to be tracked to chronic total occlusion. The elongate member has a transducer located at its distal end. An acoustic activation material will be plugged into the distal end of the elongated member. The system also includes an external imaging system constructed and arranged to generate an image of chronic total occlusion. The external imaging system may also be configured to generate ultrasonic energy waves, which in turn vibrate the acoustically activated material located at the distal end of the elongate member. These vibrations in turn produce mechanical energy that can be used to penetrate and cross the CTO.

  In US patent application Ser. No. 13 / 553,659, Richter teaches an apparatus and method for guided penetration of chronic total occlusion. The present invention relates to an apparatus that facilitates accurate placement of a guidewire and perforation tip into a blood vessel during reopening of a CTO. The apparatus comprises an imaging system that can detect lesions, vessel walls, and guidewire tips in real time. “Preferably, the device also facilitates penetration of CTO or other obstructions in the vessel. The method of using the device of the present invention facilitates the treatment of occlusions, vascular wall punctures and mistubes. Avoid or reduce complications and risks associated with the treatment of obstruction, such as the creation of cavities. "

  In US Pat. No. 7,763,012, Petrick et al. Teaches a catheter and method for crossing a CTO. The catheter consists of an elongated tubular member having a deflectable tip at the distal end. “The catheter is advanced to the region of interest in the artery proximal to the lesion. The control wire is operated to direct the deflectable tip toward the lesion. The guide wire is routed through the catheter lumen. Is advanced into and crosses the lesion. "

  In US Pat. No. 8,241,315, Jensen et al. Teach devices and methods that are configured to penetrate occlusions while limiting inadvertent vascular injury. The device includes an elongated sheath and a stylet disposed within the elongated sheath. The stylet includes a lumen from the proximal end to the distal end, which will allow passage of the guide wire after the occlusion has been pierced. In use, “the stylet can be moved distally so that the distal region of the stylet penetrates at least partially into the occlusion. The stylet extends through the proximal cap. After that, the guidewire can pass through the occlusion, and the resuming assembly is then advanced further through the occlusion, the balloon is placed near the distal cap, the stylet is centered and the distal Can be passed across the cap. "

  Still, success rates using these new technologies have been reported to vary from 50-70% due to various factors, including operator experience. In addition, cost, complexity, the need for complex preparations, and the long-term training required for proper use of these CTO devices can prevent its extensive and cost-effective use. Thus, despite these technological developments, there is still a great need for simple, safe, easy to operate, efficient and cost effective CTO devices.

US Pat. No. 6,599,304 US Pat. No. 8,062,316 US Pat. No. 8,021,330 US Pat. No. 7,763,012 US Pat. No. 8,241,315

  The present invention provides devices and methods for the treatment of vascular occlusions. The object of the present invention is one of the overall attempts to restore normal circulatory function with the advantage of a reinforced inner tube, easy controllability, and a shape that prevents vascular damage but maximizes occlusion fracture. As a part, to provide a route for placement of guidewires, interventional devices, and catheters, to destroy vascular occlusions or other obstructions formed within the vessel.

  In a first embodiment of the invention, the vascular perforation device has a main body. The main body has several components that help direct and mechanically break the occlusion. The device has an outer tubular member. The inside of the outer tubular member is an inner tubular member interposed therein. At the proximal ends of the outer and inner tubular members is a distal cap that is sealed to both the inner and outer tubular members. The distal cap is preferably a C-cup type that does not have a sharp edge for piercing the vessel wall. At the distal end of the device is a plurality of distal end loops that protrude from the distal end cap of the main body. The plurality of outer loops protrude from the outer tubular member proximal to the distal end loop. As the main body is advanced into the CTO, the operator spins the main body either manually or mechanically. The loop on the distal end mechanically breaks the CTO in front of it. As the loop on the distal end advances forward into the CTO, the outer loop on the outer tubular member mechanically breaks the CTO closer to the vessel wall. Because all loops have curved edges, the device is unlikely to puncture the vessel wall even when the loop touches the vessel wall.

  In one aspect of the invention, the inner tubular member is reinforced with one or more helical coiled wires. Preferably, two helical coiled wires surround the inner tubular member and are secured to the outer surface of the inner tubular member (by polymer glue or another anchoring material) in a double helix manner. The spiral wound wire bends within the vascular lumen and allows the main body flexibility to adapt to the vascular pathway. Surrounding the inner tubular member with the wire has the advantage of strengthening the main body shaft so that it will not twist when the main body curves along the vessel path. Coiled wires also have the advantage of improving the steering and pushability of the main body when advanced inside diseased blood vessels or inside obstructed hard fibrous calcified plaques.

  In another aspect of the invention, the device has an expandable material, such as a balloon, that encapsulates at least a portion of the main body and surrounds the outer tubular member of the main body. The distal end of the balloon is proximal to the outer loop. By being configured in this manner, when the balloon is inflated, the balloon presses against the vessel wall and places the main body of the device in the center of the vessel. The use of an inflatable balloon thus prevents mechanical disruption of the occlusion from occurring near the center of the vessel, and thus prevents undesired turning into the vessel body at the main body and distal end of the device. , Has the advantage of centering the main body.

  The distal end cap is sealed to the proximal ends of the inner and outer tubular members. The cap has a central hole that creates an opening from the lumen of the inner tubular member out of the device so that a guidewire can be inserted into and retracted through the central hole of the device. The guide wire can be used for further therapeutic procedures. In addition, the distal end cap may have a central parabore that allows multiple wire loops to protrude from the cap and break the occlusion.

  In another embodiment, the CTO device has a motor unit to assist in rotating the main body and / or the drilling tip. The motor unit has an electric motor for providing torque to the main body that spins a pair of opposing loops and breaks the CTO, and threaded inner and outer motor unit tubular bodies. The motor unit is connected to the main body via these motor unit inner and outer tubular members. To assist the rotation of the main body, the motor unit tubular member can be converted into a linear force when the electric motor pivots the tubular member, which causes the distal end of the device to pass through the CTO. It has a helical threaded surface so that it can be driven. The locking screw may lock the motor unit to the main body.

  In another embodiment of the invention, the main body is partitioned into two units: a drilling unit and a stationary unit. The stationary unit can still be inserted linearly into the blood vessel and retracted, but does not rotate when the motor unit rotates. Thus, the stationary unit is a rotating stationary unit. Instead of the motor unit being directly coupled to the main body of the device, the motor unit is coupled to a torque transmitting member that is housed within the stationary unit. The stationary unit has a stationary unit outer tubular member and an inner tubular member.

  A torque transmitting member (also known as a drive shaft) extends into the elongated lumen of the stationary unit inner tubular member and connects to the drilling unit via a coupling member. The piercing unit has a loop on its outer wall and a distal end cap as described above.

  The advantage of the main body separated into a stationary unit and a drilling unit is that instead of the entire main body rotating, only the small rotating part of the main body (ie the drilling unit) rotates. The miniature rotation unit prevents unintended damage that can occur if the device rotates relative to the vessel wall and would create additional frictional forces that damage the vessel wall.

  In one aspect of the stationary unit and perforation unit embodiment, a guidewire tubule having a guidewire lumen is disposed between the inner tubular member and the outer tubular member of the stationary unit, and the guidewire enters through the proximal hole. Retreat through the distal bore of the outer tubular member of the stationary unit. The guide wire can then be inserted through the main lumen and left in the patient after the device is removed for use in further treatment.

  In another aspect of the invention, a motor sensor is incorporated into the distal end of the main body of the drilling unit and a microprocessor is incorporated into the motor unit. The microprocessor acquires and analyzes the data transmitted from the sensors relating to the movement of the drilling unit, and in turn sends commands guided by the operator to the motor unit. In this way, the speed and characteristics of the rotation of the distal end of the device or perforation unit can be more precisely controlled by the operator to suit the CTO lesion characteristics.

  In another embodiment of the present invention, the additional structure helps align the vascular device within the center of the vascular lumen. The vascular perforation device has a stationary unit and a perforation unit. The stationary unit has an outer tubular member, an inner tubular member interposed within the outer tubular member, and a plurality of curved alignment structures extending from the outer tubular member. A torque transmitting member, known as the drive shaft, is interposed within the inner tubular member and provides rotation to the drilling unit without rotating the outer tubular member of the stationary unit. The curved alignment structure allows the vascular perforator to deviate and penetrate the vascular wall with an alignment structure in which the vascular perforator is centered within the blood vessel and the tip provides support between the stationary unit and the vascular wall. Makes it possible to prevent. The rotary drilling unit is located at the distal end of the vascular punch and is connected to the stationary unit via a drive shaft that rotates the distal tip at the distal end of the drilling unit. The distal end tip has a distal end loop protruding from the tip that breaks the occlusion in the blood vessel as the loop is advanced and rotated through the occlusion.

  In another embodiment of the vascular perforator with a curved alignment structure extending from the outer tubular member, the stationary unit has a guidewire tubule interposed therein, the guidewire proximate the vascular perforator. It can be inserted through the end and withdrawn from the perforator through a guide wire hole at the distal end of the stationary unit.

  A method of crossing a vascular occlusion using the aforementioned device is also disclosed. The steps involved in traversing the occlusion initially include positioning any of the aforementioned devices such that the distal end of the device is proximate to the occlusion. The distal end of the device is rotated so that the loop breaks the occlusion. As the device rotates, the operator advances the device through the occlusion. In another aspect of the method of crossing the occlusion, the operator advances the guidewire through the device.

FIG. 1A illustrates a front cross-sectional view of the main body of the vascular perforation device. FIG. 1B illustrates a front view of the device of FIG. 1A. FIG. 1C illustrates a side view of the device of FIG. 1A. FIG. 1D illustrates a bottom view of the device of FIG. 1A. FIG. 1E illustrates a bottom cross-sectional view of the device of FIG. 1A. FIG. 1F illustrates a front view of the inner tubular member of the device of FIG. 1A. FIG. 2A illustrates a front cross-sectional view of the device of FIG. 1B having an inflatable balloon. FIG. 2B illustrates a side view of the device of FIG. 1C with an inflatable balloon. FIG. 3A illustrates a front cross-sectional view of an alternative embodiment of the distal end of the vascular perforation device. FIG. 3B illustrates a front view of the device of FIG. 3A having a drilling unit and a rotating stationary unit. FIG. 3C illustrates a side view of the device of FIG. 3A. FIG. 3D illustrates a bottom cross-sectional view of the stationary unit of FIG. 3A. FIG. 4 illustrates a side cross-sectional view of the proximal end of the device of FIG. 3A. FIG. 5A illustrates a side cross-sectional view of the motor unit inner tubular member. 5B illustrates a side view of the motor unit inner tubular member of FIG. 5A. FIG. 6A illustrates a side cross-sectional view of the motor unit outer tubular member. 6B illustrates a perspective view of the motor unit outer tubular member of FIG. 6A. FIG. 7A illustrates a side cross-sectional view of the motor unit inner tubular member interposed within the motor unit outer tubular member. FIG. 7B illustrates a side view of the motor unit inner tubular member interposed within the motor unit outer tubular member of FIG. 7A. FIG. 8A illustrates a side view of a motor unit assembled over the main body of a CTO device that is inserted into a blood vessel. FIG. 8B illustrates a cross-sectional view of the motor unit assembled over the main body of the vascular perforation device. FIG. 9 is an exemplary view of a vascular perforation device inserted through a stoma in a patient's groin, with the distal end of the vascular perforation device approaching an occlusion. FIG. 10A is a side cross-sectional view of the device of FIG. 1A in a blood vessel prior to entering an occlusion. FIG. 10B is a side cross-sectional view of the device of FIG. 1A within the occlusion. FIG. 10C is a front cross-sectional view of the device of FIG. 1A after passing through the occlusion and after a guide wire has been inserted. FIG. 11 is a front cross-sectional view of the device of FIG. 3A after passing through the occlusion and after a guide wire has been inserted. FIG. 12A is a perspective view of a vascular perforator having an alignment structure extending from the outer tubular member of the perforator. FIG. 12B is a cross-sectional view of the device of FIG. 12A. FIG. 13A is a perspective view of a vascular perforator having an alignment structure extending from an outer tubular member and guidewire tubules and exit holes for placement of the guidewire. FIG. 13B is a cross-sectional view of the device of FIG. 13A. 14 is a top view of the distal tip of any of the vascular perforators illustrated in FIGS. 12A-13B. FIG. 15 is a cross-sectional view of a vascular perforator having an impedance sensor and a wire that transmits impedance information through a drive shaft. FIG. 16 is a front view of the distal end of a device having a distal loop exposed to the sensing region to transmit impedance.

  The present invention will now be described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown. However, the present invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. While the description of the present invention is in the context of vascular treatment, the present invention may also be used in any other body passage that is deemed useful.

  When an element is referred to as being “on” another element, it is understood that it can be directly on the other element, or that intervening elements may exist between them. Let's go. Similarly, when one element is referred to as being attached to another element, it can be attached directly to another element or via an intervening element that may exist in between. . As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items.

  The terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and / or sections, but these elements, components, regions, It will be understood that layers and / or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer or section from another element, component, region, layer or section.

  The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an”, and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. Further, the terms “comprises” and / or “comprising”, or “includes” and / or “including” or “having” and / Or “has”, as used herein, defines the presence of the described feature, region, integer, step, action, element, and / or component, but is one or more It will be understood that this does not exclude the presence or addition of other features, areas, integers, steps, operations, elements, components, and / or groups thereof that exceed.

  Furthermore, relative terms such as “lower” or “bottom” and “upper” or “top” are used herein to describe the relationship of one element to another as illustrated in the figures. Can be done. It will be understood that relative terms are intended to encompass different orientations of the device in addition to the orientation depicted in the figures.

  The terms “distal” and “proximal” are used in the following description with respect to position or orientation relative to the treating clinician. “Distal” or “distal” describes the position in a direction away from or away from the operator and refers to the tip of the CTO device closest to the occlusion. “Proximal” and “proximal” describe the position in the vicinity of or toward the operator and are away from the occlusion.

  Unless defined otherwise, all terms used herein generally have the same meaning as understood by one of ordinary skill in the art to which this invention belongs. In addition, terms such as those defined in commonly used dictionaries should be construed as having a meaning consistent with their meaning in the relevant technical field and context of the present disclosure, and as such herein It will be understood that unless defined otherwise, it is not to be interpreted in an idealized or excessively formal sense.

  As shown in FIGS. 1A-1E, the main body 100 comprises two tubular members, an inner tubular member 11 disposed within the outer tubular member 10. Inner tubular member 11 has a lumen 38 through which a guidewire can be passed. A guidewire coated with a hydrophilic polymer is generally used to cross an occlusive lesion inside a blood vessel. The polymer on the guidewire is activated upon contact with water, making the guidewire surface very lubricious and advancing the guidewire across the narrow cracks and holes contained inside the CTO's atherosclerotic plaque Promote. A guide wire can be used to facilitate drilling through the CTO.

  Between the inner tubular member 11 and the outer tubular member 10, there is an intertubular space 12, a distal cap that can be in the shape of a C-cup that seals the distal ends of both tubular members 11, 10. 15 is sealed at both ends of the main body 100. In a preferred embodiment, the inner tubular member 11 is at least 5 mm longer than the outer tubular member 10 such that the C-cup mold 15 has a depth of at least 5 mm. The curved C-cup shape prevents sharp edges from contacting the blood vessel and potentially damaging the vessel wall 50.

  The outer surface of the outer tubular member 10 is coated with a highly lubricious hydrophilic polymer (such as polytetrafluoroethylene or other hydrophilic polymer known to those skilled in the art) to allow free rotation and rotation in healthy or diseased blood vessels. Directional movement may be promoted. The distal and proximal ends of the main body 100 and the cap 15 may be sealed with similar polymers. The main body 100 may be of various lengths, but preferably the main body 100 of 90 cm to 130 cm is suitable for most clinical applications.

  The outer surface 11 of the inner tubular member is reinforced with one or more wires. These wires are coated with a hydrophilic polymer. As shown in FIGS. 1A, 1E, 1F, 3A, 3B and 4, the inner tubular member 11 is reinforced with wires 13, 14 coated with two hydrophilic polymers. These wires 13 and 14 are wound around the inner tubular member 11 in a double spiral manner.

  In the embodiment illustrated in FIGS. 1A-1E, the distal cap 15 has a central bore 16 that is aligned with the inner tubular member 11 and provides a withdrawal path for the guidewire to exit through the central lumen 38. In the vicinity of the central hole 16, there is a pair of central side holes 17, as shown in FIG. 1D. The central side holes 17 are each about 180 degrees from each other around the circumference of the cap 15 when viewed in cross section. Proximal to the central side hole 17 is a pair of outer tubular member holes 18. In one embodiment, the pair of outer tubular member holes 18 are located proximal from 0.5 cm to 2.0 cm from the most distal region of the distal cap 15. In a preferred embodiment, the pair of outer tubular member holes 18 are about 1.0 cm from the distal cap 15. In the embodiment illustrated in FIG. 1, the outer tubular member holes 18 are each positioned approximately 180 degrees from each other, and the outer tubular member holes 18 are positioned orthogonal to the central parabore 17. In a preferred embodiment, the outer tubular member holes 18 are each about 4.0 mm to 5.0 mm apart from each other along the major axis of the outer tubular member of the main body 100.

  Each of the wires 13 and 14 is spirally coiled around the shaft of the inner tubular member 11. The wires 13, 14 are drawn through the central side holes 17, 18 to form a distal end loop 20 and a pair of outer loops 19. The loops 18, 19 are secured to the holes 17, 18 using a point fixing polymer. In some embodiments, the distal end loop 20 may be oriented slightly inward (not shown) toward the central axis. Perhaps this orientation will reduce the chance of vessel wall trauma caused by the distal loop 20 while the device is spinning.

  This type of loop design and configuration, in which there is a distal pair of loops 20 directed toward occlusion and an outer loop 19 oriented in the direction of vessel wall 50, is as the device penetrates and advances through the CTO. This is advantageous because the device will penetrate the CTO proximal cap at four different locations located at about 90 degrees from each other at different depths of the CTO.

  In a preferred embodiment, the main body of the device is approximately 5 mm in diameter at the level of the outer loop 19 and helps to keep the distal end of the main body 100 in the central portion of the occlusion during device use. A centrally located device within the occluded plaque has less chance of trauma to the vessel wall and has a higher chance of reentry into the true lumen of the vessel located distal to the CTO. In contrast, a device whose distal end is positioned closer to the vessel wall has a higher chance of vessel trauma, leading to vessel wall dissociation and / or penetration. In addition, if the distal end of the device is eccentric and placed close to the vessel wall, its chance to re-enter the true lumen of the vessel is scarce. If the device tip is closer to the vessel wall, the tip may also generate a subintimal dissection surface that is distal to the CTO instead of intended reentry into the true vessel lumen. Can be advanced in the vessel wall.

  FIG. 1F illustrates the inner tubular member 11 without the outer tubular member 10. Here, the wires 13, 14 are seen in a double helix fashion around the inner tubule member and can form an outer loop 20 and a distal loop 19 that protrude from the inner tubular member 11. When assembled, the outer loop 19 protrudes from the outer tubular member 10 and the distal loop protrudes from the distal cap 15 as illustrated in FIGS. 1A-1E.

  In another embodiment of the device, dilatation balloon 52 encloses a portion of main body 100 as depicted in FIGS. 2A and 2B. In a preferred embodiment, the balloon 52 is about 5.0 cm to 7.0 cm long, 5.0 mm to 6.0 mm in diameter, and is made from a polyethylene material. Balloon 52 is positioned across outer tubular member 10 about 1 cm proximal to outer loop 19. In this embodiment, the intertubular space 12 between the outer tubular member 10 and the inner tubular member 11 is used as an injection lumen. Balloon 52 communicates with an infusion lumen that extends to the proximal end of the main body. When inflated with the infusion medium, the balloon 52 repositions the distal end of the main body 100 toward a central location inside the vessel and also widens the passage created by the device inside the CTO, and thus Promote stent placement.

  3A-3D illustrate another embodiment of the main body 100 of the CTO device. The main body 100 is partitioned into a stationary unit 110 and a drilling unit 21. The piercing unit 21 spins when torque is applied through the torque transmitting member 26 that extends longitudinally through the lumen 38 of the main body 100. Torque transmission member 26 can be a solid or hollow wire, tube, or shaft made from a variety of materials such as stainless steel (SS304) or similar compatible materials. The torque transmitting member 26 is coupled to the drilling unit 21 via a coupler 27 that connects the drilling unit to the stationary unit 110 and forms the entire main body 100 of the CTO device. In one embodiment, the perforation unit 21 is about 2.0-4.0 cm long. In a preferred embodiment, the drilling unit 21 is about 3.0 cm long. The piercing unit 21 has the features of the distal end of the embodiment illustrated in FIGS. 1A-1F. However, in the embodiment of the piercing unit 21 shown in FIGS. 3A-C, there is no distal end cap hole 16 that allows the guide wire to pass through the lumen 38 of the distal cap 15. The proximal end of the piercing unit 21 is covered with a proximal cap 42 and the distal end 110 of the stationary unit is covered with a distal cap 40. The coupler 27 attaches to the proximal cap 42 on the drilling unit 21 and connects the stationary unit 110 to the drilling unit 21.

  One advantage of the partitioned main body 100 embodiment of FIGS. 3A-3C is that the drilling unit 21 spins independently of the stationary unit 110 and does not spin when the torque transmitting member 26 rotates. . Because only the small perforation unit 21 spins, the majority of the main body 100 in the blood vessel remains rotationally stationary and therefore does not produce any frictional force against the inner wall of the blood vessel. Thus, the operator will have better control of the exact location of the drilling action of the device. The compartmented main body 100 increases device safety and prevents undesired forces on the unoccluded area of the blood vessel.

  To accommodate the guide wire, in this embodiment, a guide wire tubular member 44 is located in the intertubular space 12 of the stationary unit 110 having a guide wire lumen 28. The guide wire 39 can be passed through the guide wire lumen 28 and exit the stationary unit 110 at the guide wire exit hole 29 so that the guide wire can be used in later procedures. In one embodiment, exit hole 29 is located 0.5-5.0 cm proximal to distal end stationary unit 110. In a preferred embodiment, exit hole 29 is located approximately 1.0 cm proximal to the distal end of stationary unit 110. The helical coiled wires 13, 14 are spirally wound and secured around the inner tubular member 11 of the stationary unit, and the second pair of wires 24, 25 are wound around the inner tubular member 11 of the drilling unit 21. And fixed there. In a preferred embodiment, the first wire 24 is spirally wound around the inner tubular member 11 to form two of the four loops 19, 20 (one outer tubular member hole 18 and one center). Projecting from the distal distal cap hole 17). The second wire 25 is spirally wrapped around the inner tubular member 11 to form the other two of the four loops (projecting from the opposed outer tubular member hole 18 and the opposed central para-distal cap hole 17). To do). The loops 19, 20 on the distal unit 21 are brought through the holes 17, 18 and point fixed as described above in FIGS. 1A-1E.

  FIG. 4 illustrates the proximal end of the stationary unit 110 of FIG. The torque transmission member 26 retracts from the proximal end of the stationary unit 110, attaches to the motor unit, and applies torque to the torque transmission member 26. The guide wire tubular member 44 has a guide wire entry hole 30 for insertion of the guide wire into the stationary unit 110.

  5A and 5B illustrate a motor unit inner tubular member 31, and FIGS. 6A, 6B, 7 A, and 7 B illustrate a motor unit outer tubule member 32 that fits over the motor unit inner tubular member 31. An assembled motor unit 130 illustrating the electric motor 36, inner and outer motor unit tubular members 31, 32 attached to the main body 100 of the device is illustrated in FIGS. 8A and 8B.

  In a preferred embodiment, the inner tubular member of the motor unit 31 is disposed within the lumen 46 of the outer tubular member of the motor unit 32 that is approximately 15 cm to 20 cm long and, in turn, approximately 5-7 cm. The The lumen diameter of the motor unit inner tubular member 31 is such that the motor unit 130 can be easily slid over the main body 100 as shown in FIGS. 7A and 7B. About 0.5 mm to 1.0 mm larger. The outer surface 33 of the motor unit inner tubule member 31 has a corresponding threaded inner surface 34 for the motor unit inner tubule member 31 to fit into the motor unit inner tubule member 31. It is threaded into a helical configuration so that it can fit inside. The motor unit inner tubular member 31 can spin in the outer tubular member 32 upward or downward. The threaded configuration of the motor unit tubule members 31, 32 converts a portion of the torque from the electric motor 36 into linear motion and thus facilitates advancement of the distal end of the device through the CTO.

  One embodiment of the electric motor has a gear system that is attached to the main body 100 and is configured to generate oscillating curve torque motion within the rotor unit. In one embodiment, the rotor unit in turn transmits a curved oscillating motion with a circular third of the main body 110 of the device. This pendulum movement of the main body 100, when transmitted to the main body 100 or the proximal end of the drilling unit 21, will have less chance of plaque removal and distal embolism compared to spin transfer. The motor unit 130 can be locked and unlocked from the main body, preferably via a locking screw device 35 made from polyethylene material or equivalent.

  The electric motor 36 may be a DC or AC motor having a type of gear box known by those skilled in the art. In use, the operator inserts the main body 100 through the stoma in the groin into the blood vessel and advances the distal end of the main body 100 adjacent to the CTO 37, as shown in the exemplary configuration in FIG. . The motor unit 130 is inserted coaxially over the main body 100 and advanced to the vicinity of the skin entry point of the main body 100. The motor unit inner tubular member 31 is then locked to the main body 100 using the locking screw member 35. The electric motor 36 is then inserted coaxially over the main body 110, advanced, and locked to the distal end of the motor unit inner tubule member 31. The electric motor 36 is powered and the operator guides the inward and outward movement of the locked motor unit inner tubule member 31 and main body 100 combination. The torque generated by the motor 36 and the advancement of the inner tubular member 31 within the outer tubule member 32 transmit both linear and rotational movement to the distal end of the main body 100. In the embodiment of FIGS. 1A-E, the motor unit 130 transmits rotational movement to the entire main body 110, whereas in the embodiment depicted in FIGS. 3A-D, the motor unit 130 is connected to the torque transmission device 26. Only the rotational movement is transmitted to the drilling unit 21.

  As the main body 100 or the drilling unit 21 spins, the wire loops 19, 20 in turn advance through the proximal cap of the CTO, as shown in FIGS. 10A-C. After successfully crossing the entire length of occlusion 37, the operator confirms the intraluminal position of the distal end of main body 100 and injects a small amount of radiopaque contrast agent through the guidewire lumen under fluoroscopy guidance. To do. The operator then advances guidewire 39 through device lumen 38 and into vascular lumen 48 as shown in FIGS. 10C and 11.

  In one embodiment of the device, the electric motor 36 rotates in a curvilinear motion and does not include the inner and outer motor tubular members 31, 32. Here, the rotating axle of the electric motor 36 is directly attached to the torque transmission device 25 and the torque will be transmitted directly from the axle of the motor 36 to the drilling unit 21. In this embodiment, the operator uses an inward push to impart linear motion to the main body 100 and the motor 36 provides torque to the drilling unit 21 to break up the CTO.

  In the embodiment illustrated in FIGS. 8A and 8B, the operator locks the motor 36 to the torque transmission device and the rotor unit of the electric motor 36 rotates the drilling unit in a curvilinear manner via the torque transmission device 26. During the operation, the main body 100 is gently advanced into the blood vessel 48 and through the CTO 37. Here, the operator adds a linear movement of the curved movement of the drilling unit 21 at the forward tip of the main body 100 and the distal end of the main body 100. In this embodiment, the motor unit 130 is not used for linear movement because the operator controls the forward movement of the main body 100.

  FIG. 11 illustrates an exemplary embodiment of the device shown in FIGS. 3A-D inside vessel 50 passed through CTO 37. Here, the guidewire 39 exits from a hole 29 located approximately 1 cm proximal to the distal end of the stationary unit 110. Guidewire 39 remains in vascular lumen 48 after main body 100 is withdrawn from the patient. The guide wire 39 can then be used for further therapeutic intervention.

  12A and 12B illustrate an exemplary embodiment of a vascular perforator 120 having a curved alignment structure 50 for aligning the perforator 120 to the center within the blood vessel. FIG. 12A illustrates the perforator 120 in a perspective view and FIG. 12B illustrates the perforator 120 in a cross-sectional view. There are two main sections of the punch 120, namely the stationary unit 110 and the rotary drilling unit 21. The stationary unit 110 may move along the blood vessel path, but does not rotate when the torque transmitting member (drive shaft) 26 rotates. Surrounding the drive shaft 26 in the stationary unit 110 is the inner tubular member 11. Surrounding the inner tubular member 11 is an outer tubular member 10 that is spatially separated by an inner tubular space or lumen. The inner tubular member 11 does not extend throughout the perforator 120. Rather, the inner tubular member 11 has a termination region 66 where the drive shaft 26 retracts from the inner tubular member 11 and enters the rotary perforation unit 21.

  As the drive shaft 26 retracts from the enclosure of the inner tubular member 11 into the piercing unit 21, the drive shaft 26 remains encapsulated within the outer tubular member 10 and drives the drive shaft 26 of the piercing unit 21 of the device 120. Enter the inner hypotube 56 to be sealed.

  The curved alignment structure 50 is supported by the outer tubular member 10, which may have an inner layer 56 that assists in attaching the curved alignment structure 50 to the outer tubular member 10. The outer tubular member 10 and the inner layer 56 keep the distal region (ie, tip) of the piercing unit 21 from bending or joining. Inner hypotube 56 is secured to drive shaft 26 by either adhesive, epoxy, and / or welds 54. The inner hypotube 56 is used as a way to splice the drive shaft 26 to the tip of the drilling unit 21 while maintaining a consistent surface for supporting rotational loads. Between the inner hypotube 56 and the outer tubular member, a hypotube-like inner space (hypotube lumen) that allows the drive shaft 26 to rotate without rotating the stationary unit 110 of the device 120. There are 64.

  The distal end of the piercing unit 21 may have a curved atraumatic cap 15 to prevent blood vessel piercing. Extending from the distal end of the piercing unit 21 is a distal loop 20 for breaking the occlusion (as described above) as the piercing unit 21 rotates and advances through a blood vessel having one or more occlusions. Is). The distal loop 20 may have various configurations relative to each other, such as having an overlapping configuration (as illustrated in FIGS. 12-14) or offset from each other (as illustrated in FIGS. 1-3). It may be. To attach the distal loop 20 to the drive shaft 26, the non-looped end portion of the distal loop 20 may extend at least partially along the drive shaft 26, where the drive The region of the distal loop 20 that extends the length of the shaft 26 may be secured to the drive shaft 26 and / or the hypotube 56 via an adhesive, epoxy, and / or weld 58. it can. In a preferred embodiment, the proximal end of the loop 20 follows the drive shaft 26 and terminates at about 1 mm to 2 mm.

  A curved alignment structure 50 projects from the outer tubular member 10 through a hole 54 in the outer tubular member 10 to help center the vessel perforator. In the embodiment shown, there are three equally spaced curved alignment structures 50. However, when the curved alignment structure 50 supports the inner wall of the blood vessel, there are any number of alignment structures arranged in any number of ways that allow the vessel perforator 120 to be centered in the lumen of the blood vessel. Can exist.

  The curved alignment structure 50 may be made from any type of wire material, and specific embodiments may include a wire made from a shape memory alloy having superelastic properties, such as Nitinol. The curved alignment structure 50 can also be coated with a hydrophilic polymer coating to help advance the device through the blood vessel. Although the curved alignment structure 50 may be of any length and height, a preferred embodiment has a curved structure that extends from about 3 mm to 8 mm from the surface of the outer tubular member 10 of the device. In a preferred embodiment, the curved alignment structures are each attached at two locations along the stationary unit 110, ie, a proximal location and a distal location that are separated by approximately 25-50 mm.

  The curved alignment structure 50 is due to the curved alignment structure 50 not having any area that can pierce the blood vessel because the only protruding area is curved and supports the vessel wall instead of penetrating it. Press against the blood vessel without causing damage. Aiding the support of the alignment structure 50 is a coiled alignment member loop 52 at each end of each curved alignment structure 50. These coils 52 allow the curved alignment structure 50 to collapse within a tight space near the surface of the outer tubular member 10 of the stationary unit 110 of the device. The coiled section 52 of the alignment structure 50 facilitates the alignment structure 50 to bend into a collapsed position (as compared to a non-coiled alignment structure) while the device is being introduced and removed through a narrow guide catheter. Each of the coils 52 extends from the outer tubular member 10 through a curved alignment structure opening (entrance and exit hole) 54, and through the adhesive, epoxy, or weld, of the outer tubular member 10 and / or the outer tubular member 60. Fixed on or in the inner layer. In one embodiment, the stationary unit hole on the outer tubular member 10 on the stationary unit 110 is configured to be inclined about 20-80 degrees. In one embodiment, the entry and exit holes 54 are inclined about 60 degrees laterally (not downward or upward) with respect to the major axis of the device 120, 130. In a preferred embodiment, the coil 52 comprises 4-10 loops before transitioning to the non-coiled region of the curved matching structure 50.

  13A and 13B illustrate a perspective view and a cross-sectional view of a vascular punch 130, similar to the vascular punch 120 of FIGS. 12A and 12B, respectively. The embodiment of FIGS. 13A and 13B illustrates additional elements of the guidewire tubule 44, which can be inserted through the vascular perforator 130 and withdrawn through the guidewire hole 29. In order to accommodate the additional space required for the guidewire tubule 44, the drive shaft 26 and the proximal portion of the inner tubular member 11 are offset from the center of the lumen 12 to allow for the guidewire tubule 44. Create a space. As described above with reference to FIGS. 12A and 12B, the embodiment of FIGS. 13A and 13B similarly includes a drive shaft 26 connected to the piercing unit 21, an inner hypotube 56, a stationary unit 110 and a piercing unit 21. And a curved alignment structure 50 that aligns the distal portion of the tube within the central region of the vessel lumen.

  FIG. 14 illustrates a top view of the distal tip with three curved alignment structures 50 spaced about 120 degrees equidistant from each other of the vascular perforators 120, 130 depicted in FIGS. 12-13. Equidistant alignment allows the curved alignment structure 50 to support the inner surface of the blood vessel and center the distal region of the device 120, 130. Although the curved alignment structure 50 may extend in various directions from the surface of the outer tubular member 10, in a preferred embodiment, the curved alignment structure 50 of the outer tubular member 10 is illustrated in FIG. Extends non-perpendicular from the surface. In a preferred embodiment, the alignment structure 50 extends about 45 degrees from the surface of the outer tubular member 50. In another embodiment, the curved alignment structure 50 extends from about 60 degrees relative to the outer tubular member surface. By extending non-vertically, the alignment structure 50 can be better crushed in a tight space near the surface of the outer tubular member 10. This crushability is advantageous when the device 120, 130 is introduced and withdrawn through the narrow guide sheath, and the alignment structure 50 is provided when the alignment structure 50 extends vertically from the outer surface of the outer tubular member 10. Crushing more easily. In a preferred embodiment, the guide sheath has an inner diameter of about 2.0-2.2 mm and the body of the device 120, 130 around the outer tubular member is about 1.8 mm, however, the device 120, The overall diameter of 130 is preferably about 5 mm to 6 mm wide in the open position when the alignment structure 50 is considered, but when crushed against the outer tubular member 10, the diameter of the device 120, 130. The whole is about 2 mm to fit through the guide sheath.

  In another embodiment, the vascular perforator 140 has an impedance sensor 51 as illustrated in FIGS. 15 and 16. FIG. 15 illustrates a cross-sectional view of the vascular perforator 140 and FIG. 16 illustrates the vascular perforator tip 21 and the exposed sensor area 41 on the distal loop 20. The impedance sensor 41 is disclosed in Cao et al. U.S. patent application Ser. No. 12 / 893,707 and Wernet et al. For use in a variety of sensors within a tissue ablation system as described in US patent application Ser. No. 11 / 438,678, both of which are fully incorporated herein by reference in their entirety. It can be used in any of the aforementioned vascular perforator embodiments, such as impedance sensors and interfaces. The signal from the sensor 41 may be transmitted to a receiver located at the proximal end of the device via a transmission wire 43 extending through the drive shaft 26. The drive shaft may have a hollow channel 45 that allows placement of the transmission wire 43 into the vascular perforator. The mechanical impedance properties of the outer membrane are different from atherosclerotic non-calcified and calcified plaques. The impedance information can therefore be used to determine the location of the distal loop 20 relative to calcified or non-calcified plaque, which in turn guides the operator to properly cross the lesion. Minimize the chance of vessel wall dissection or puncture. The perforator includes a tip 21 such as an impedance sensing circuit and circuitry and sensors disclosed in Deno et al., US patent application Ser. No. 12 / 346,592, which is fully incorporated by reference herein in its entirety. And location sensing and orientation circuitry for determining the location and orientation of the device. Failure to successfully cross the CTO often occurs while passing through highly calcified plaques, instead of information from the impedance sensor guiding the distal loop 20 safely and dissociating or penetrating blood vessels. , Will help to successfully cross the CTO.

  Although all aspects of the invention have been described with reference to the drawings, this description of various embodiments and methods should not be construed in a limiting sense. The foregoing is presented for purposes of illustration and description. It should be understood that all aspects of the invention are not limited to the specific depictions, configurations, or relative proportions described herein, but depend on various conditions and variables. The actual dimensions and materials of devices constructed in accordance with the principles of the present invention may clearly extend beyond the listed ranges and materials without departing from their basic principles. The specification is not intended to be exhaustive or to limit the invention to the precise form disclosed herein. Various modifications and imaginary changes in the form and details of specific embodiments of the disclosed invention, as well as other variations of the invention, will be apparent to those skilled in the art upon reference to the disclosure. Accordingly, the appended claims are intended to cover any such modifications or variations of the described embodiments that fall within the true spirit and scope of this invention.

Claims (31)

A vascular perforation device for crossing an occluded blood vessel, said device having a main body;
An outer tubular member;
An inner tubular member interposed within the outer tubular member;
A distal end cap secured to the outer tubular member and the inner tubular member;
A plurality of distal end loops projecting from the distal end cap to break the occlusion;
A plurality of outer loops projecting from the outer tubular member to crush the occlusion;
Thereby, the distal end loop and the outer loop break the occlusion within the blood vessel as the distal end loop and the outer loop are rotated and pushed through the occluded blood vessel.   The device of claim 1, wherein the plurality of distal end loops are a pair of distal end loops, and the plurality of outer loops are a pair of outer loops substantially orthogonal to the outer loop.   The device of claim 1, wherein the plurality of outer loops are positioned about 0.5 cm to 1.0 cm from a distal end of the outer tubular member. And further comprising at least one wire helical coil surrounding the inner tubular member;
Thereby, the helical coil increases the strength and flexibility of the inner tubular member as compared to the strength and flexibility of the inner tubular member without the at least one helical coil surrounding the inner tubular member. The device of claim 1, which improves.   The device of claim 4, wherein the at least one wire helical coil has a hydrophilic polymer coating.   The device of claim 4, wherein the at least one wire helical coil is a two wire helical coil.   The device of claim 4, wherein the plurality of distal loops and the plurality of outer loops are formed from the at least one wire helical coil. An expandable balloon configured for inflation, further comprising an expandable balloon enclosing at least a portion of the outer tubular member;
Thereby, when the expandable balloon is inflated, the expandable balloon expands the occlusion and places the device in a central vascular position, thereby substantially into the lower intimal surface of the blood vessel. The device of claim 1, which prevents unintended entry of the device.   The inner tubular member has a central lumen for guide wire exchange, and the distal end cap has a hole located in the center for guide wire exchange. The device according to 1.   The device of claim 1, wherein the distal end cap is a C-cup type distal end cap. The device is
A motor unit,
An electric motor;
A motor unit inner tubular member having a threaded outer surface;
A motor unit outer tubular member having a threaded inner surface configured to engage the threaded outer surface of the motor unit inner tubular member, wherein the motor unit inner tubular member is the motor A motor unit comprising: a motor unit outer tubular member positioned within the inner lumen of the unit outer tubular member;
A locking screw for locking the motor unit to the motor unit inner tubular member; and
The electric motor thereby transmits torque to the main body, thereby rotating the plurality of distal loops and the plurality of outer loops to break the blockage in the blocked vessel. The device according to 1. A motion sensor in the main body for measuring the speed and characteristics of rotation of the main body;
And a microprocessor for receiving and analyzing speed and feedback data,
12. The device of claim 11, whereby the motion sensor and microprocessor allow greater control of the device in conjunction with operator instructions. The main body is partitioned into a rotating stationary unit and a drilling unit,
The rotating stationary unit is:
A rotating stationary unit outer tubular member;
A rotating stationary unit inner tubular member interposed in the rotating stationary unit outer tubular member;
A torque transmission member interposed in the rotating stationary unit inner tubular member, the torque transmission member connected distally to the drilling unit;
The drilling unit is
The outer tubular member;
The inner tubular member;
The distal end cap;
The plurality of distal end loops;
A plurality of outer loops, and
2. The device of claim 1, wherein only the main body perforation unit rotates when the device rotates, thereby preventing unnecessary frictional forces against blood vessels that are not occluded.   14. The device of claim 13, further comprising a guidewire tubular member disposed within the rotating stationary unit for inserting a guidewire into a patient. An outer tubular member; an inner tubular member interposed within the outer tubular member; a distal end cap secured to the outer tubular member and the inner tubular member; and a plurality of distal ends projecting from the distal end cap A method of traversing a vascular occlusion using a vascular drilling device comprising a distal loop and a plurality of outer loops protruding from said outer tubular member,
Positioning the device such that the distal end of the device is proximate to an occlusion;
Rotating at least a portion of the device to break the occlusion;
Advancing the device through the occlusion. The vascular perforation device further comprises an expandable balloon that encloses at least a portion of the outer tubular member;
16. The method of claim 15, further comprising inflating the balloon for dilation of the occlusion.   The method of claim 15, further comprising advancing a guidewire through the device. A vascular perforation device for centering and intersecting an occluded blood vessel, said device comprising a stationary unit and a perforation unit;
The stationary unit is
An outer tubular member;
An inner tubular member interposed within the outer tubular member;
A torque transmission member interposed in the inner tubular member extending from the stationary unit to the drilling unit;
A plurality of curved alignment structures extending from the outer tubular member, thereby aligning the device within a central region of a blood vessel, thereby preventing accidental penetration of the vessel wall With structure and
The drilling unit is
A device comprising: a plurality of distal end loops protruding from a distal region of the perforation unit, whereby the loop rotates and breaks the occlusion as it advances through the occlusion. Each of the curved alignment structures comprises a coiled alignment member that is integral with the curved alignment structure, thereby allowing the curved alignment structure to compress and expand,
The device of claim 18, wherein each of the coiled alignment members is attached to the stationary unit.   The device of claim 19, wherein each of the coiled alignment members comprises 4-10 coils.   The device of claim 18, wherein the torque transmitting member is substantially encapsulated and attached thereto by an inner rotatable hypotube.   The device of claim 18, wherein the plurality of curved matching structural loops are made from a composition comprising nitinol (nickel and titanium) and a hydrophilic polymer coating.   The device of claim 18, wherein the plurality of curved alignment structures are three curved alignment structures that are substantially equally spaced from each other along the outer tubular member.   The device of claim 18, wherein the plurality of curved alignment structures extend non-vertically from the outer tubular member.   25. The device of claim 24, wherein the plurality of curved alignment structures extend about 45 degrees from a surface of the outer tubular member. The curved alignment structure extends from an outer surface of the outer tubular member in a range of about 3 mm to 8 mm;
The device of claim 18, wherein each of the curved alignment structures is about 25 mm to 50 mm in length. A guidewire tubule interposed in the stationary unit of the vascular perforator;
The device of claim 18, further comprising a guidewire tubule opening in the outer tubular member, thereby allowing a practitioner to insert a guidewire through the device. .   A sensor coupled to the piercing tip that allows the measurement of mechanical impedance to indicate the presence or absence of calcified or non-calcified plaque so that the operator knows the location of the distal tip relative to the plaque The device of claim 18, further comprising a sensor that makes it possible to do so. A vascular perforation device for aligning the center and crossing an occluded blood vessel, comprising a stationary unit and a perforation unit;
The stationary unit is
An outer tubular member;
An inner tubular member interposed within the outer tubular member;
A torque transmitting member interposed within the inner tubular member extending from the stationary unit to the perforating unit, substantially enclosed by and attached to an inner rotatable hypotube A transmission member;
A plurality of coiled curved alignment structures extending non-perpendicularly from the outer tubular member, wherein the curved alignment structures extend in a range from about 3 mm to 8 mm from an outer surface of the outer tubular member; A curved alignment structure having a length of about 25 mm to 50 mm,
Thereby, the plurality of curved alignment structures align the device within the central region of the blood vessel, thereby preventing accidental penetration of the vessel wall;
The drilling unit is
A device comprising: a plurality of distal end loops protruding from a distal region of the perforation unit, whereby the loop rotates and breaks the occlusion as it advances through the occlusion. A method of traversing a vascular occlusion using a vascular perforation device comprising a stationary unit and a piercing unit, the stationary unit comprising: an outer tubular member; and an inner tubular member interposed within the outer tubular member; A torque transmitting member extending from the stationary unit to the drilling unit, interposed in the inner tubular member, and a plurality of curved alignment structures extending from the outer tubular member, the drilling unit comprising: The torque transmitting member and a plurality of distal end loops protruding from a distal region of the drilling unit;
The method
Positioning the device such that the distal end of the device is proximate to an occlusion;
Rotating at least a portion of the device to break the occlusion;
Advancing the device through the occlusion.   The method of claim 12, further comprising advancing a guidewire through the device.

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