Vascular re-entry catheter

Abstract

To provide devices and methods for treatment of vascular conditions associated by crossing a chronic total occlusion (CTO) in a blood vessel by exploring a subintimal space in a more simplified procedure with a reduced error rate and reduced trauma to the blood vessel.SOLUTION: A catheter 1 has a guide tip 3 including at least one wing 8a, 8b for crossing a CTO lesion in an artery via exploring a subintimal space. The catheter can include one or more exit ports 6 and radiopaque markers 4 for steering a re-entry wire through one of the exit ports. The catheter may include a number of spiral-cut sections 15 with varying characteristics to provide different strength and flexibility along the axial direction.SELECTED DRAWING: Figure 2A

Description

Technical Field

[0001] Cross - reference to related applications This application claims priority to U.S. Provisional Patent Application No. 62 / 050,456, filed on September 15, 2014, and , U.S. Provisional Patent Application No. 62 / 060,152, filed on October 6, 2014, and the entire disclosure of each of these is incorporated herein by reference .

Background Art

[0002] Chronic total occlusion lesions ("CTO") are complete or nearly complete blockages of blood vessels, such as in the coronary arteries. Up to 30% of patients with coronary artery disease have a CTO somewhere along the left or right arterial system. Conventionally, CTOs have typically been treated by bypass procedures, where autologous or synthetic blood vessels are anastomosed to locations on the blood vessels upstream and downstream of the occlusive lesion. Such bypass procedures are effective but are quite traumatic to the patient . . . .

[0003] In recent years, catheter - based endovascular procedures have been developed to treat CTOs, with improving success rates. Such procedures include angioplasty, atherectomy, stent implantation, etc., and the catheter is typically introduced percutaneously. Treating CTOs percutaneously significantly reduces the need for surgery (coronary artery bypass grafting - CABG). Furthermore, CTO percutaneous coronary intervention (PCI) can, as a result, provide symptomatic relief to the patient, re - establish coronary blood flow, improve left ventricular function, and potentially provide survival benefits. Peripheral vascular occlusion lesions outside the coronary vessel anatomical tissue can also be treated by such interventions . . . . . . .

[0004] ​ Before such catheter - based treatment can be performed, it is usually necessary to pass a guidewire across the occluded lesion to provide access for the interventional catheter. Available techniques for crossing an occluded lesion generally fall into two approaches: a antegrade approach, which involves passing the wire from the proximal end to the distal end of the occluded lesion (either straight through the CTO or through the sub - intimal space), and a retrograde approach, which refers to accessing the CTO of the distal cap through collateral vessels. The latter is usually reserved as a second - choice strategy in case of failure of antegrade intimal passage.

[0005] For CTO treatment by PCI with antegrade access, several different devices have been developed, including the CrossBoss™ system and the Stingray™ system. See http: / / www.bostonscientific.com / en - US / medical - specialties / interventional - cardiology / procedures - and - treatments / coronary - chronic - total - occlusion - system.html (Last accessed: September 10, 2015), and also refer to U.S. Patents No. 8,632,556, 8,202,246, 8,636,712, 8,721,675, 6,511,458.

[0006] The CrossBoss™ catheter can be used to facilitate crossing of a CTO by simply blunt - dissecting through a small micro - channel within the blood vessel through the occluded lesion, or if this fails to cross, the device can create a path within the sub - intimal space of the vessel wall. ​ can proceed from. By way of example, FIG. 1A shows a CrossBoss™ catheter 100 in schematic, and the CrossBoss™ catheter 100 is attached to a flexible proximal shaft 120 that is torqueable via rotation of a handle 130 and includes a rounded / non-tapering distal tip 108, and the shaft 120 has a lumen for receiving a guidewire 102.

[0007] The Stingray™ catheter, Stingray™ guidewire can be used after the CrossBoss™ catheter to facilitate guiding a guidewire or reentry device from a subintimal space into the true lumen of an artery. By way of example, FIG. 1B shows a Stingray™ catheter having a laterally expandable balloon 210 positioned distally, and a proximal shaft 220 having a central guidewire lumen 225. Side ports 212 and 214 are located on either side of a portion of a central lumen in which the balloon 210 is disposed, and are identified by radiopaque markers 232 and 234. The side ports 212 and 214 communicate with the central guidewire lumen 225 to facilitate guiding a pre-loaded tip reentry device 240 (angled with respect to the central lumen) out of the catheter from one of the side ports.

[0008] The CrossBoss™ catheter can be used to pass through the proximal cap portion of the CTO by rotation of the non-tapering tip. However, if this is not successful, In such cases, it is necessary to use both the CrossBoss (trademark) catheter and the Stingray (trademark) catheter. This procedure can be described generally as follows. (1) Advance the CrossBoss (trademark) catheter above the guidewire to the connection between the distal tip of the catheter and the surrounding tissue, (2) Pierce the catheter tip through the vessel wall and advance the CrossBoss (trademark) device into the vessel wall so that the tip extends longitudinally across the entire occlusive lesion and establish a flow path in the subintimal space of the vessel wall, (3) Withdraw the CrossBoss (trademark) catheter above the guidewire, (4) Advance the Stingray (trademark) catheter above the guidewire, (5) Inflate the balloon of the Stingray (trademark) catheter to cause the Stingray (trademark) balloon to assume one of two orientations, (6) Withdraw the guidewire from the Stingray (trademark) catheter, (7) Advance a reentry device having a preconfigured tip in a compressed state into the lumen of the Stingray (trademark) catheter, (8) Using fluoroscopy assistance, manipulate the tip of the reentry device so that the tip exits from one of the side ports of the Stingray (trademark) catheter in its natural state and into the arterial lumen (true lumen).

[0009] The Stingray (trademark) catheter can then be withdrawn, and the reentry device remains in place, thereby establishing a path from the proximal segment of the vascular lumen and the distal segment of the vascular lumen. Thereafter, a balloon catheter is introduced It can be placed at the site of O. The stent can be further implanted at the site expanded by the balloon.

[0010] The above-described treatment of the subintimal passage using the combination of CrossBoss (trademark) and Stingray (trademark) catheters overcomes certain problems of previous-generation techniques in direct antegrade CTO access, but this treatment is complex and time-consuming. Furthermore, switching from CrossBoss (trademark) to Stingray (trademark) may invite unexpected errors. For example, (such that the Stingray (trademark) catheter can be introduced above the guidewire) when the CrossBoss (trademark) catheter is withdrawn from the guidewire, the guidewire may shift its position within the subintimal space or, even worse, may retreat from the subintimal space, in which case the operator will not be able to properly introduce the Stingray (trademark) catheter above the guidewire into the subintimal space. As a result, it may be necessary to repeat the previous step of using the CrossBoss (trademark) catheter to cross to the subintimal space. Furthermore, when the Stingray (trademark) catheter is advanced to inflate the distal balloon of the Stingray (trademark) catheter in the subintimal space, excessive dissection and substantial trauma may occur in the layers of the vessel wall. It is desirable to provide an apparatus and method for treating related vascular pathologies by exploring the subintimal space in a simpler procedure with a reduced error rate and reduced trauma to the blood vessel and then crossing to the CTO within the blood vessel. (trademark) catheter. Furthermore, when the Stingray (trademark) catheter is advanced to inflate the distal balloon of the Stingray (trademark) catheter in the subintimal space, excessive dissection and substantial trauma may occur in the layers of the vessel wall.

[0011] It is desirable to provide an apparatus and method for treating related vascular pathologies by exploring the subintimal space in a simpler procedure with a reduced error rate and reduced trauma to the blood vessel and then crossing to the CTO within the blood vessel.

Summary of the Invention

[0012] In one aspect, the present invention provides a catheter device. The catheter device has a longitudinal axis, a tube wall including at least one side port, at least one radiopaque marker, and a distal catheter tube portion including at least one wing that projects radially outward from the tube wall.

[0013] In some embodiments, the tube wall includes two wings that project radially outward in opposite directions. In some of these embodiments, at least one side port is radially offset by about 90° from each of the two wings. In certain embodiments, a first side port and a second side port are radially offset from each other by about 180°.

[0014] In some embodiments, at least one side port is chamfered.

[0015] In some embodiments, the catheter device includes a radiopaque marker affixed on the distal catheter tube portion that is axially aligned with at least one side port. In other embodiments, the catheter device includes a radiopaque marker that surrounds at least one side port.

[0016] In some embodiments, the tube wall includes a first side port and a second side port that is displaced from the first side port in the longitudinal and radial directions, and the second side port is located distally of the first side port. In some of these embodiments, the tube wall includes a first radiopaque marker located longitudinally between the first side port and the second side port. situated longitudinally between the first side port and the second side port. ​​​​​​​​It includes a first marker and a second radiopaque marker distal to the second side port.

[0017] In some embodiments, at least one wing is part of a guide tip that engages the distal end of the catheter. In other embodiments, at least one wing can be placed within a distance from the distal end of the catheter.

[0018] In some embodiments, the catheter device includes at least one helical cut, and at least one side port is located within the helical cut.

[0019] In certain embodiments, the catheter device includes at least two helical cuts having different pitches.

[0020] In some embodiments, the catheter device includes at least one helical cut having an interrupted helix.

[0021] In certain embodiments, the catheter device includes at least two interrupted helical cuts having different pitches.

[0022] At least one wing can be formed of a polymeric material, metal, or composite material.

[0023] In another aspect, the present invention provides a method for facilitating treatment of an occlusion in a blood vessel with a catheter device as described herein. The blood vessel has a vessel wall that defines a vessel lumen containing the occlusion. The occlusion separates the vessel lumen into a proximal segment and a distal segment. The catheter device has a lumen and at least one side port and at least one The catheter includes a distal end including a guide tip and a vessel wall including a radiopaque marker. The guide tip includes a catheter tube portion having a small diameter extending radially outward in diametrically opposed directions. The method includes a step of positioning the catheter device adjacent to the occlusion. and a small amount of fluid to establish a flow path in the vessel wall that extends longitudinally across the occlusion. The guide tip is closed within the vessel wall until at least one side port is positioned distal to the occlusion. advancing the catheter adjacent to the occlusion and directing at least one side port toward the vessel lumen. and inserting a re-entry device through the lumen of the catheter device, the insertion device having a distal end portion in a compressed state; The distal end portion of the re-entry device is configured to, in a natural state, extend from at least one side port into the lumen of the blood vessel. and manipulating the re-entry device to exit the distal segment of the vein. [Brief explanation of the drawings]

[0024]

Figure 1A

Figure 1B

Figure 2A

Figure 2B

Figure 2C

Figure 2D

Figure 2E

Figure 2F

Figure 2G

Figure 3A

Figure 3B

Figure 3C

Figure 3D

Figure 3E

Figure 3F

Figure 3G

Figure 3H

Figure 4A

Figure 4B

Figure 5A

Figure 5B

Figure 6

Figure 7A

Figure 7B

Figure 8A

Figure 8B

Figure 8C

Figure 8D

Figure 9A

Figure 9B

Figure 9C

Figure 10A

Figure 10B

Figure 10C

Figure 11

DETAILED DESCRIPTION OF THE INVENTION

[0025] In one aspect, the present invention provides a catheter device (or catheter). The catheter can be used for treating a CTO by passing directly through the CTO or by passing through the CTO via a subintimal space. In another aspect, the present invention provides a method of treating a CTO.

[0026] As illustrated in FIGS. 2A and 2B, a catheter device 1 according to one embodiment of the present invention includes a distal tube portion 11 having a tube wall 10 and a longitudinal axis L. On the distal end 101 of the distal tube portion 11 (which is also the distal end of the catheter 1), there is a blunt guide tip (or tip) 3, and the blunt guide tip (or tip) 3 surrounds the distal end portion of the distal tube portion 11. The guide tip 3 includes a base portion 3a and two outer wings 8a and 8b that project radially outward from the peripheral portion of the tip 3. In certain embodiments, the guide tip 3 wings can include

[0027] fewer or more wings, e.g., only one wing, or more than two wings, as described herein. When two wings are present, the wings can be radially separated or displaced by an angle of about 30 to about 90°, or about 90 to about 180°, or a fraction therebetween. For example, the angle can be about 30°, about 60°, about 90°, about 120°, about 150°, or about 180°. As shown in FIGS. 2A and 2B, in some embodiments, the two wings 8a and 8b can be positioned opposite each other around the guide tip, i.e., along substantially the diameter

[0028] Figure 2C shows a cross-sectional view of a portion of the tube 1 of Figure 2A along the longitudinal axis L. Figures 2B and 2C As shown in, the outer diameter of the guide tip ODt (without wings) is larger than the outer diameter of the distal tube portion 11 (OD), and the outer diameter (OD) of the distal tube portion 11 is larger than the inner diameter (ID) of the distal tube portion 11 The wings have a bottom width Wb, that is, a height Hw measured from the OD to the highest point of the wings The leading edge of the wing is generally round, that is, smooth

[0029] As shown in Figure 2B, the guide tip 3 can, in a particular embodiment, completely surround the peripheral portion of the distal tube portion 11 In an alternative embodiment, and as illustrated in Figures 2D and 2E, the guide tip 3 (including the base 3a and the wings 8a / 8b) does not completely surround the distal tube portion 11 For example, the guide tip 3 only surrounds 3 / 4, 2 / 3, 1 / 4, or a smaller percentage of the peripheral portion of the distal tube portion 11 In a particular embodiment, and as illustrated in Figure 2E, the guide tip 3 may include a plurality of separate base portions (3a, 3b) distributed along the peripheral portion of the distal tube portion 11 In a particular embodiment, the guide tip 3 having the wings 8a and 8b is located at a distance, for example, 1 to about 100 mm (see Figure 2F), about 10 mm to about 75 mm, or about 25 to about 50 mm, away from the distal end 101 of the tube portion 11, for example, at a distance dw In a particular embodiment, one or more wings can be positioned without being supported by a portion of the base of the tip, for example, at the distal end 101 and / or away from the distal end 101

[0030]

[0031] ​​​​​​It can be directly joined to the tube. As illustrated in FIG. 2G, the wings 8a / 8b are directly joined to the distal end of the distal tube portion 11 (e.g., by welding, adhesion, etc.) without being a part of the tip surrounding the distal tube portion 11. In such a situation, the wing itself can also be regarded as the only component of the guide tip. Without being a part of the tip surrounding the distal tube portion 11, it is directly joined to the distal end of the distal tube portion 11 (e.g., by welding, adhesion, etc.). In such a situation, the wing itself can also be regarded as the only component of the guide tip. From the perspective of flexibility, depending on the material and structural requirements, the thickness of the tube wall 10 can vary, for example, from about 0.002 inches to about 0.02 inches, from about 0.05 mm to 2 mm, such as from 0.05 mm to about 1 mm, about 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm,

[0032] 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, etc. The inner diameter (ID) of the lumen of the distal tube portion 11 can vary, for example, from about 0.01 inches to about 0.04 inches, or from about 0.1 mm to about 2 mm, or from about 0.25 mm to about 1 mm, such as from about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, etc. The outer diameter (OD) of the lumen of the distal tube portion can also vary, for example, from about 0.2 mm to about 3 mm, such as from about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, etc. The thickness of the tube wall, the inner diameter ID, and the outer diameter OD can each be constant throughout the length of the catheter or can vary along the length of the catheter. From the perspective of flexibility, depending on the material and structural requirements, the thickness of the tube wall 10 can vary, for example, from about 0.002 inches to about 0.02 inches, from about 0.05 mm to 2 mm, such as from 0.05 mm to about 1 mm, about 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, etc. The inner diameter (ID) of the lumen of the distal tube portion 11 can vary, for example, from about 0.01 inches to about 0.04 inches, or from about 0.1 mm to about 2 mm, or from about 0.25 mm to about 1 mm, such as from about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, etc. The outer diameter (OD) of the lumen of the distal tube portion can also vary, for example, from about 0.2 mm to about 3 mm, such as from about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, etc. The thickness of the tube wall, the inner diameter ID, and the outer diameter OD can each be constant throughout the length of the catheter or can vary along the length of the catheter. 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, etc. The thickness of the tube wall, the inner diameter ID, and the outer diameter OD can each be constant throughout the length of the catheter or can vary along the length of the catheter. 1.4 mm, 1.5 mm, etc. The thickness of the tube wall, the inner diameter ID, and the outer diameter OD can each be constant throughout the length of the catheter or can vary along the length of the catheter. The thickness of the tube wall, the inner diameter ID, and the outer diameter OD can each be constant throughout the length of the catheter or can vary along the length of the catheter. The thickness of the tube wall, the inner diameter ID, and the outer diameter OD can each be constant throughout the length of the catheter or can vary along the length of the catheter. The thickness of the tube wall, the inner diameter ID, and the outer diameter OD can each be constant throughout the length of the catheter or can vary along the length of the catheter.

[0033] In certain embodiments, the height Hw of the wing is about 5% to about 5 0% (including about 10% to about 40%, about 15% to about 30%, or about 20%) of the outer diameter ODt of the tip 3, or the height Hw of the wing can be about 10% to about 15%, about 15 % to about 30%, or about 5% to about 45% of the ODt. In some embodiments the bottom width Wb of the wing can be about 5% to 30% of the outer diameter ODt of the tip 3. The axial length of the base of the wing can be substantially the same as the axial length Lt of the guide tip 3 (see FIG. 2C), about 5 mm to about 20 mm, about 7.5 mm to about 15 mm, about 8 mm to 12 mm, or about 10 mm. Alternatively, the axial length of the base of the wing can be less than the axial length Lt of the guide tip 3. The tube wall 10 and the guide tip 3 can be formed of metal, polymer, or composite material. Suitable metals include cobalt chrome, stainless steel, MP35N, nickel titanium, and metal alloys such as shape memory materials such as nitinol. Alternatively, the tube wall can be composed of a polymer such as aliphatic polyether urethane, polyamide, low density polyethylene (LDPE), polypropylene, or a mixture of polymers. The distal tube portion can also be formed of a polymer-metal composite such as a bonded or abutting composition of metal and polymer that generally forms a tube-like structure. The distal catheter tube portion can be formed of metal, such as stainless steel. The guide tip 3 and / or the wing 8a / 8b can be made of the same material as the tube wall or a different material. For example,

[0034] ​​​​​​​​​​​​The guide tip may include a radiopaque substance such as a radiopaque filler composition. The guide tip is capable of varying in a rain gauge from a substance such as soft rubber to a rigid composite polymer or plastic including metals and softer outer components such as polymers. Also, the wings may be made of the same or different materials as the rest of the guide tip. For example, the wings may be formed of a polymer material, a shape memory material such as nitinol, or a metal such as cobalt chromium.

[0035] FIG. 3A shows a micrograph of a guide tip 3 including two wings 8a and 8b extending from the top and bottom, respectively. The left side of the guide tip 101 can be engaged with the distal end of a catheter as described above. FIG. 3B shows a rear view of the guide tip. FIG. 3C is a cross-sectional view along line A-A of FIG. 3B (of the wings 8a / 8b). FIG. 3D is a cross-sectional view along line B-B of FIG. 3B showing that a base portion of the tip 3 has a rounded leading edge 102. The leading edge may alternatively include a tapered portion 103 as shown in FIG. 3E, and the tapered portion 103 can be smooth, i.e., have a non-sharp cutting edge, and control of blunt microdissection is possible.

[0036] The peripheral contour of the wing along the axial direction is generally convex in shape and can be, for example, in the form of a smooth long circular curve (see FIGS. 2A / 2C / 3A / 3C). In other embodiments, and as illustrated in FIG. 3F, the side profile or shape of the wing can be rectangular (111) trapezoidal (113), or a rectangle or trapezoid having rounded outer peripheral corners (112 and 114, respectively), or sinusoidal (115).

[0037] ​Three or more wings can be positioned around the periphery of the guide tip 3. For example, multiple wings can be positioned uniformly or non-uniformly along the periphery, and can be arranged symmetrically or asymmetrically. The multiple wings may have exactly the same or different shapes and / or sizes. As shown in FIG. 3G, eight wings (8a, 8b, 8c, 8 d, 8e, 8f, 8g, 8h) are arranged at or near the distal end of the distal tube portion. The lateral cross-section of these wings (perpendicular to the axial direction of the distal tube portion) can vary in size and shape as shown (e.g., a rectangle having generally bell-shaped, arcuate, rounded corners, etc.), and the outer surface of the wing usually forms a smooth transition with the outer wall of the tip.

[0038] In certain embodiments, the wing can form a continuous line with the base portion of the guide tip. For example, as illustrated in FIG. 3H, which is a front view of the guide tip 3, the wings 8a and 8b of the tip 3 protrude outward due to the anisotropic lateral cross-sectional shape of the guide tip 3. In such embodiments, the maximum cross-sectional width, D1 (which can be regarded as the "wing length") of the guide tip 3 is greater than the minimum cross-sectional width, D0, of the guide tip 3. For example, D1 can be about 10% to about 500%, such as about 50% to about 200% greater. In some embodiments, D1 can be about 10%, 20%, 50%, 80%, 100 %, 150%, 200%, 250%, or 300% greater than the inner diameter of the tip (which is approximately equal to

[0039] (Optionally having wings) The guide tip 3 fuses the guide tip 3 onto the tube wall 10 or positioned on the distal end of the distal tube portion 11 by joining in other ways can be. The wing can be made as an integral part of the tip 3, or the wing can be joined or otherwise attached to the base of the tip 3 by mechanical joining (e.g., friction), adhesion, chemical bonding, etc.

[0040] The catheter 1 can be a microlumen catheter having one lumen for use in connection with a guiding catheter. The catheter 1 can also have two or more lumens, e.g., two, three, four, or five lumens surrounded by the tube wall 1 0. The lumens can have equal or unequal inner diameters. One lumen can be connected to a balloon that can be fixed to the catheter 1 A guidable guide wire can be inserted through the lumen of the catheter The catheter can be designed to optimize parameters such as push, torque, torsional performance, tracking and transition. The wall thickness of the catheter can vary along the length so that the flexibility of the catheter can vary as needed or desired along the length.

[0041] As shown in FIGS. 2C and 2F, the tube wall 10 can be covered by a protective jacket 10a to provide a smooth outer surface while not reducing the flexibility of the distal tube portion 11. The jacket 10 a is made of a polymer, e.g., a single or multiple layer co-extruded polymer tubular structure and or by surrounding the tube wall 10 with heat to shrink the tubular structure or by coating the tube wall 10 through an immersion coating process. The polymer jacket material can be nylon, polyether block amide, PTFE, FEP, PFA, PET, PEEK, etc. ​​​​​​​ It can be done. Further, the distal tube portion 11 (or the entire length of the catheter 1) can be coated with a hydrophilic polymer coating to enhance followability. The hydrophilic polymer coating can include a polyelectrolyte and / or a nonionic hydrophilic polymer. The polyelectrolyte polymer can include poly(acrylamide-co-acrylic acid) salts, poly(methacrylamide-co-acrylic acid) salts, poly(acrylamide-co-methacrylic acid) salts, etc. The nonionic hydrophilic polymer can include poly(lactam), for example, polyvinylpyrrolidone (PVP), polyurethane, homopolymers and copolymers of acrylic and methacrylic acids, polyvinyl alcohol, polyvinyl ether, maleic anhydride-based copolymers, polyesters, hydroxypropyl cellulose, heparin, dextran, polypeptides, etc. For example, refer to U.S. Patent No. 6,458,867 and U.S. Patent No. 8,871,8 69. Also, FIG. 2A shows two radiopaque markers 4 and 5 positioned along the distal tube portion 11 that facilitate X-ray imaging of the positioning of the catheter 1 within the vascular lumen. The markers can be made of radiopaque substances such as platinum metal, platinum iridium, Ta, gold in the form of a wire coil or band, vapor deposition deposits, and radiopaque powders or fillers, for example, barium sulfate, bismuth trioxide, bismuth subcarbonate, etc. embedded or encapsulated within a polymeric matrix. Alternatively, the markers can be made of a radiopaque polymer such as radiopaque polyurethane. The markers can be in the form of a band surrounding the outer sheath of the distal tube portion 11, as shown in FIG. 2A.

[0042]

[0043] As shown in FIG. 2A, the distal tube portion 11 between the markers 4 and 5 is a side port (or The side port (or exit port) 6 is located on the wall 10 of the tube. Alternatively, another side portion between the guide tip 3 and the marker 5 may be formed as a through hole. There may be a port 7 (this side port may also be located proximal to marker 4). The side ports 6 and 7 are connected to the distal tube portion 11 in a direction away from the axis L of the distal tube portion 11. To be used at the exit of a reentry wire or another reentry device having a diameter smaller than that of one For example, the re-entry wire can have a pre-biased distal tip. As used herein, "pre-biased" when referring to the distal tip of a re-entry wire The term "compressed" refers to the fact that the tip of the re-entrant wire can be in two different states, compressed and uncompressed (or self-compressed). In the compressed state, the distal tip is The distal tip can be axially aligned with the rest of the shaft, and in an uncompressed state, the distal tip The angle (bend) of the wire with the rest of the wire to facilitate the exit of the catheter from the side port. ) is formed.

[0044] The side ports 6 and 7 are spaced approximately 180° from each other, e.g., as shown in FIG. 2A. The radial positioning can be offset by approximately 180° (±10°). The radial displacement of the side port relative to the flange is about 0° to 90°, e.g., 10°, 2 The angle may range from 0°, 30°, 50°, 70°, and 80°. The side port location is offset radially from the wing at approximately 90°, as shown in Figure 2A. It is possible. In this way, when the two wings 8a / 8b are positioned within a stable configuration in the subintimal space of the artery, the port 6 can face towards the true lumen of the artery or can be considered to be opposed to the lumen, and the port 7 can be opposed to the opposite side. When positioned within a stable configuration in the subintimal space of the artery, the port 6 can face towards the true lumen of the artery or can be considered to be opposed to the lumen, and the port 7 can be opposed to the opposite side. When positioned within a stable configuration in the subintimal space of the artery, the port 6 can face towards the true lumen of the artery or can be considered to be opposed to the lumen, and the port 7 can be opposed to the opposite side. It is possible.

[0045] The side ports can be symmetric in shape and can be circular, semi-circular, oval, semi-oval, rectangular, or semi-rectangular. The ports can have the same shape and size (i.e., surface area) or can be different from each other and are configured to allow the passage of a re-entry wire or another medical device through the port. The dimensions of the port can be adjusted, for example, to a diameter in the range of about 0.05 mm to about 1.0 mm to accommodate different types of medical devices or wires. Erglis et al., [Eurointervention] 2010:6, 1-8. The distal tube portion 11 accommodates three or more outlet ports, for example, three, four, five, six, seven, eight,... n ports along the length direction and can be radially dispersed as desired. The side ports can be symmetric in shape and can be circular, semi-circular, oval, semi-oval, rectangular, or semi-rectangular. The ports can have the same shape and size (i.e., surface area) or can be different from each other and are configured to allow the passage of a re-entry wire or another medical device through the port. The dimensions of the port can be adjusted, for example, to a diameter in the range of about 0.05 mm to about 1.0 mm to accommodate different types of medical devices or wires. Erglis et al., [Eurointervention] 2010:6, 1-8. The distal tube portion 11 accommodates three or more outlet ports, for example, three, four, five, six, seven, eight,... n ports along the length direction and can be radially dispersed as desired. The side ports can be symmetric in shape and can be circular, semi-circular, oval, semi-oval, rectangular, or semi-rectangular. The ports can have the same shape and size (i.e., surface area) or can be different from each other and are configured to allow the passage of a re-entry wire or another medical device through the port. The dimensions of the port can be adjusted, for example, to a diameter in the range of about 0.05 mm to about 1.0 mm to accommodate different types of medical devices or wires. Erglis et al., [Eurointervention] 2010:6, 1-8. The distal tube portion 11 accommodates three or more outlet ports, for example, three, four, five, six, seven, eight,... n ports along the length direction and can be radially dispersed as desired. The side ports can be symmetric in shape and can be circular, semi-circular, oval, semi-oval, rectangular, or semi-rectangular. The ports can have the same shape and size (i.e., surface area) or can be different from each other and are configured to allow the passage of a re-entry wire or another medical device through the port. The dimensions of the port can be adjusted, for example, to a diameter in the range of about 0.05 mm to about 1.0 mm to accommodate different types of medical devices or wires. Erglis et al., [Eurointervention] 2010:6, 1-8. The distal tube portion 11 accommodates three or more outlet ports, for example, three, four, five, six, seven, eight,... n ports along the length direction and can be radially dispersed as desired. The side ports can be symmetric in shape and can be circular, semi-circular, oval, semi-oval, rectangular, or semi-rectangular. The ports can have the same shape and size (i.e., surface area) or can be different from each other and are configured to allow the passage of a re-entry wire or another medical device through the port. The dimensions of the port can be adjusted, for example, to a diameter in the range of about 0.05 mm to about 1.0 mm to accommodate different types of medical devices or wires. Erglis et al., [Eurointervention] 2010:6, 1-8. The distal tube portion 11 accommodates three or more outlet ports, for example, three, four, five, six, seven, eight,... n ports along the length direction and can be radially dispersed as desired. The side ports can be symmetric in shape and can be circular, semi-circular, oval, semi-oval, rectangular, or semi-rectangular. The ports can have the same shape and size (i.e., surface area) or can be different from each other and are configured to allow the passage of a re-entry wire or another medical device through the port. The dimensions of the port can be adjusted, for example, to a diameter in the range of about 0.05 mm to about 1.0 mm to accommodate different types of medical devices or wires. Erglis et al., [Eurointervention] 2010:6, 1-8. The distal tube portion 11 accommodates three or more outlet ports, for example, three, four, five, six, seven, eight,... n ports along the length direction and can be radially dispersed as desired. The side ports can be symmetric in shape and can be circular, semi-circular, oval, semi-oval, rectangular, or semi-rectangular. The ports can have the same shape and size (i.e., surface area) or can be different from each other and are configured to allow the passage of a re-entry wire or another medical device through the port. The dimensions of the port can be adjusted, for example, to a diameter in the range of about 0.05 mm to about 1.0 mm to accommodate different types of medical devices or wires. Erglis et al., [Eurointervention] 2010:6, 1-8. The distal tube portion 11 accommodates three or more outlet ports, for example, three, four, five, six, seven, eight,... n ports along the length direction and can be radially dispersed as desired. The side ports can be symmetric in shape and can be circular, semi-circular, oval, semi-oval, rectangular, or semi-rectangular. The ports can have the same shape and size (i.e., surface area) or can be different from each other and are configured to allow the passage of a re-entry wire or another medical device through the port. The dimensions of the port can be adjusted, for example, to a diameter in the range of about 0.05 mm to about 1.0 mm to accommodate different types of medical devices or wires. Erglis et al., [Eurointervention] 2010:6, 1-8. The distal tube portion 11 accommodates three or more outlet ports, for example, three, four, five, six, seven, eight,... n ports along the length direction and can be radially dispersed as desired. The side ports can be symmetric in shape and can be circular, semi-circular, oval, semi-oval, rectangular, or semi-rectangular. The ports can have the same shape and size (i.e., surface area) or can be different from each other and are configured to allow the passage of a re-entry wire or another medical device through the port. The dimensions of the port can be adjusted, for example, to a diameter in the range of about 0.05 mm to about 1.0 mm to accommodate different types of medical devices or wires. Erglis et al., [Eurointervention] 2010:6, 1-8. The distal tube portion 11 accommodates three or more outlet ports, for example, three, four, five, six, seven, eight,... n ports along the length direction and can be radially dispersed as desired.

[0046] The radiopaque markers configured as bands shown in Figure 2A can be used to facilitate the determination of the position of the side ports while the distal tube portion 11 is being manipulated in the subject's anatomical tissue. As shown in Figure 4A, the markers 4a and 5a (the marker 5a can be positioned on the opposite side of the tube 11 and is thus hidden from view as shown) can also be configured as partial bands or patches that form a specific alignment with the corresponding side ports. For example, as shown in Figure 4A, the marker 4a is axially The radiopaque markers configured as bands shown in Figure 2A can be used to facilitate the determination of the position of the side ports while the distal tube portion 11 is being manipulated in the subject's anatomical tissue. As shown in Figure 4A, the markers 4a and 5a (the marker 5a can be positioned on the opposite side of the tube 11 and is thus hidden from view as shown) can also be configured as partial bands or patches that form a specific alignment with the corresponding side ports. For example, as shown in Figure 4A, the marker 4a is axially The radiopaque markers configured as bands shown in Figure 2A can be used to facilitate the determination of the position of the side ports while the distal tube portion 11 is being manipulated in the subject's anatomical tissue. As shown in Figure 4A, the markers 4a and 5a (the marker 5a can be positioned on the opposite side of the tube 11 and is thus hidden from view as shown) can also be configured as partial bands or patches that form a specific alignment with the corresponding side ports. For example, as shown in Figure 4A, the marker 4a is axially The radiopaque markers configured as bands shown in Figure 2A can be used to facilitate the determination of the position of the side ports while the distal tube portion 11 is being manipulated in the subject's anatomical tissue. As shown in Figure 4A, the markers 4a and 5a (the marker 5a can be positioned on the opposite side of the tube 11 and is thus hidden from view as shown) can also be configured as partial bands or patches that form a specific alignment with the corresponding side ports. For example, as shown in Figure 4A, the marker 4a is axially The radiopaque markers configured as bands shown in Figure 2A can be used to facilitate the determination of the position of the side ports while the distal tube portion 11 is being manipulated in the subject's anatomical tissue. As shown in Figure 4A, the markers 4a and 5a (the marker 5a can be positioned on the opposite side of the tube 11 and is thus hidden from view as shown) can also be configured as partial bands or patches that form a specific alignment with the corresponding side ports. For example, as shown in Figure 4A, the marker 4a is axially The radiopaque markers configured as bands shown in Figure 2A can be used to facilitate the determination of the position of the side ports while the distal tube portion 11 is being manipulated in the subject's anatomical tissue. As shown in Figure 4A, the markers 4a and 5a (the marker 5a can be positioned on the opposite side of the tube 11 and is thus hidden from view as shown) can also be configured as partial bands or patches that form a specific alignment with the corresponding side ports. For example, as shown in Figure 4A, the marker 4a is axially is aligned, while marker 5a is axially aligned with side port 6. Thus, the markers 4a and 5a are also radially opposed to each other, such that the side ports 6 and 7 are radially opposed. In this way, the visualization of markers 4a and 5a can be used to determine the orientation of their respective side ports. The markers can be configured in different shapes, e.g., partial circumferential bands, or any other desired shape, to

[0047] facilitate the determination of the port orientation. As shown in FIG. 4B, the markers can be configured as surface patches 4b (hidden from view and illustrated by dashed border lines) and 5b surrounding the peripheries of the respective exit ports 7 and 6. In such an

[0048] embodiment, the visible marker positions directly correspond to the side port positions. In FIG. 4A or 4B, the markers should have a sufficient size and appropriate configuration / structure (e.g., type of

[0049] radiopaque material, amount of radiopaque material loaded, etc.) to be visualized with the aid of appropriate fluoroscopy. Also shown in FIG. 4A are additional wings 8c and 8d, which are proximal to side port 6 (wings 8a and 8b are distal to side port 6). The radiopaque material can also be included within wings 8a, 8b and / or 8c, 8d, and these Other configurations of the radiopaque marker for determining the orientation of the device can also be used. WO2010 092512A1, U.S. Patent No. 8,983,577, and U.S. Patent Publication No. 201 40180068 are hereby incorporated by reference.

[0050] In some embodiments, the side port 6 (or 7) can be chamfered as shown in FIGS. 5A (perspective view) and 5 B (side cross-sectional view taken along line B-B of FIG. 5A). The chamfered configuration of the side port facilitates the smooth exit and retraction of the reentry wire 17 having a bent tip from the side port (see FIG. 5B). The bevel angle θ (see FIG. 5B) can range from about 0° to about 90°, including 10° to about 90°, about 20° to about 70°, or 40° to about 60°.

[0051] The configuration of the distal tube portion 11 of the catheter 1 shown in FIGS. 2A-2G enables the catheter 1 to be used as an effective delivery device via subintimal exploration. The advancement of the guide tip 3 can be achieved by rotation of the proximal portion of the catheter, whereby a torque application device coupled to the outer sheath of the catheter tube material, e.g., as further described herein below, transmits torque via a torque handle to the guide tip 3. The rotational advancement of the outer wings 8a and 8b within the subintimal space creates a controlled wide cut formed by the opposing wings or a more effective delamination of the vascular layers than a symmetric non-pointed tip due to the presence of a separation plane can be generated. Further, the outwardly extending wings 8a / 8b can facilitate the orientation of the catheter 1 within the subintimal space, whereby the radiopaque marker and ... ... ... In connection with the side port, the catheter 1 can also serve as an orientation device. A pre-loaded re-entry wire, or other form of re-entry device, can be manipulated and guided from one of the side ports into the true lumen with the aid of X-ray imaging (e.g., fluoroscopic X-ray pictures).

[0052] As shown in FIGS. 2A and 2C, the wall 10 of the distal tube portion 11 of the catheter 1 can include a section that includes a helical cut 15 that progresses around the longitudinal axis L of the tube. The helical cut can be made by removing the tube material from the wall using a laser, e.g., a femtosecond solid-state cutting laser. The tube portion with the helical cut can also be viewed as a ribbon or flat coil wound helically around the longitudinal axis (made from the remaining wall tube portion).

[0053] The helical cut portion of the catheter can be used directly within the vasculature and may not require an outer jacket or inner liner. Alternatively, the helical cut portion can be covered by a jacket 10a as shown and described in connection with FIGS. 2C and 2F. Also, as shown in FIG. 5A, when located within the helical cut portion of the distal tube portion 11, the port 6 can have a solid rim 61 that is not damaged by the helical cut 15 (i.e., the helical cut 15 does not cut open the edge of the side port 6). As shown in FIG. 5B, when the tube wall is covered by the jacket 10a, the outer jacket 10a can be sufficiently removed around the side port so as not to prevent the re-entry wire from exiting or retracting from the side port.

[0054] The catheter can have several different helical cut patterns, including continuous and discontinuous ones. The helical cut can be provided such that a gradual transition in bend flexibility is obtained. For example, the helical cut pattern can have a pitch that changes to increase flexibility in one or more regions. The pitch of the helical cut can be measured by the distance between points at the same radial position within two adjacent threads. In one embodiment, the pitch can increase as the helical cut progresses from the proximal position to the distal end of the catheter. In another embodiment, the pitch can decrease as the helical cut progresses from the proximal position to the distal end of the catheter. In this case, the distal end of the catheter can be more flexible. By adjusting the pitch of the helical cut, the push - force transmission, torsional resistance, torque, flexibility, and compression resistance of the catheter can be adjusted.

[0055] Helical cuts with different cut patterns can be distributed along the length of the catheter. The helical cut pattern can be continuous or discontinuous along the length of the catheter. For example, one, two, three, four, five, six, seven,..., n helical cuts can be along the length of the catheter, and within each cut, a certain cut pattern can exist, but across different cuts, the cut pattern can change, for example, from the perspective of pitch. Each cut can also accommodate a variable pitch pattern within a particular cut. Each helical cut can be, for example, from about 0.05 mm to about 10 mm, for example, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0 ​ .7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.5 mm, 2.0 mm, 3.0 mm may have a constant pitch in the range of, for example, 3.5 mm, 4.0 mm, etc. The pitch may also vary within each cut-in portion. The pitches of different helical cut-in portions may be the same or different. Alternatively, the catheter may have a continuously varying helical cut pattern along the length of the catheter. The orientation or winding direction of the helical cut-in portions within the catheter may also vary between the helical cut-in portions.

[0056] As shown in FIG. 6, a catheter 1 having a distal tube portion 11 including three consecutive helical cut-in portions S1, S2, and S3 along the longitudinal direction is illustrated. The cut-in portion S1 is located at the distal end of the catheter 1 and may include the guide tip 3 of the distal end 101 of the catheter, as well as side ports 6 and 7 displaced longitudinally in two radial directions and facing each other. The three helical cut-in portions can all be made of the same tube (e.g., a hypo tube) having a constant diameter. The distal tube portion 11 may also include a non-cut portion NS proximal to the helical cut-in portion S3. The catheter 1 further includes a proximal tube portion 13. The proximal tube portion 13 can be made of the same tube as the distal tube portion 11 or constructed from a different tube and joined to the distal tube portion 11. The proximal tube portion 13 is connected to a proximal tab 800 located at the proximal end of the catheter 1 and passes through a handle assembly, i.e., a torque imparting device 700, as described herein. The proximal tube portion 13 may also include a section RS (also referred to as a "rail-equipped" section, as described later) having a non-circular cross-sectional shape for engagement with the handle assembly 700.

[0057] The helical portions S1, S2, and S3 each can have dimensions, flexibility, a length, and a pitch suitable for the purpose of using the catheter. For example, the length and pitch of each helical portion can be selected according to performance requirements for performing a specific procedure, such as an antegrade CTO PCI procedure (e.g., the diameter, length, shape, and other configurations of the vasculature through which the catheter accessing the treatment site advances). For example, in one embodiment, the helical portion S1 can have a length in the range of about 10 cm to 15 cm and a pitch in the range of about 0.5 mm to about 1.0 mm, and the helical portion S2 can have a length in the range of about 4 to 6 cm and a pitch in the range of about 1 to about 2 mm, and the helical portion S3 can have a length in the range of about 0.5 cm to 2 cm and a pitch in the range of about 0.05 mm to about 0.3 mm . . . .

[0058] The helical cuts exemplified above are continuous in the helical cut portion. Further, the helical cuts can include an interrupted helix, i.e., a pattern of cut portions and non-cut portions of the helix. As exemplified in FIGS. 7A and 7B, the helical cut tube portion S11 of the catheter having the helical ribbon 12 has adjacent turns 14 substantially defined and separated by the interrupted helix 16, and the interrupted helix 16 includes alternating open or cut-in portions 18 and non-cut portions 20. The paths of the alternating cut and non-cut portions 18 and 20 are oblique with respect to the peripheral edge of the tube portion (in other words, the pitch angle φ shown in FIG. 7B is less than 90°). Due to the presence of the non-cut portions 20, the tube portion is stronger in extension than a typical wound ribbon or a tube having a continuous helical cut. .

[0059] Similar to what has been described herein with respect to continuous spiral cuts, interrupted spiral cuts may also be used. The indentation pattern also decreases from relatively stiff to relatively flexible regions. The side ports illustrated in connection with Figures 2A / 5A can have various pitches. Which side port 6 has an interrupted spiral cut instead of the continuous spiral shown in Figures 2A / 5A When located in the recess, the port 6 is also protected from damage by the interrupted spiral cut. The rim may have a small solid rim.

[0060] 1 shows a portion of a catheter tube in an expanded state with an interrupted spiral cut pattern. As illustrated in FIG. 7B, each helically oriented uncut portion 20 has an arcuate extent. "α", and each spirally oriented cut 18 has an arcuate extent "β". α and β can be expressed in degrees (each complete helical turn is 360°). The non-cut portion is such that the adjacent non-cut portions 20 (20a, 20b, 20c) are aligned along the longitudinal axis. so that they are not axially aligned with each other (i.e., "staggered") along a direction parallel to L. Alternatively, the unslit portion of the continuous spiral winding may be distributed in the tubular portion. Alternatively, the bending bias can be expressed as a bending bias, as shown in FIG. As shown, the unnotched portions 20 on every other turn of the interrupted spiral 16 are axially aligned. It is possible.

[0061] In some embodiments, the interrupted spiral cut is The spiral is defined as a spiral in which each turn, or rotation, has a certain number of cuts, Nc (e.g., 1.5, 2 .5, 3.5, 4.5, 5.5, etc.) can be designed to include. Nc can also be integers such as 2, 3, 4, 5,..., n, as well as other real numbers such as 2.2, 2.4, 2.7, 3.1, 3.3, etc. At a given Nc, the non-cutting range α and the cutting range β are such that each rotation has Nc repeating patterns each including the cutting part of range β near the non-cutting part of range α. α = (360 - (β Nc)) / Nc * can be chosen as. For example, at Nc = 1.5, 2.5, and 3.5, the following table shows exemplary selections for α and β for various embodiments. TIFF2025111790000002.tif159164

[0062] Figures 8A - 8D are photographs of portions of a tube having interrupted helical cuts with different pitches, as described herein.

[0063] The catheter of the present invention can include continuous helical cut portions (exemplified in FIGS. 2A, 2C, 2F, 6), interrupted helical cut portions (exemplified in FIGS. 7A - 7C), or a hybrid of both types of helical cut patterns, arranged in any order.

[0064] To facilitate the lateral position of the distal portion of the catheter tube 1 within the blood vessel of the subject, a torque applying device (i.e., a handle assembly) can be provided on the proximal portion of the catheter tube. The handle assembly can accommodate the catheter tube and include a lumen or internal opening to apply torque when a part of the handle assembly is rotated by frictional engagement with the catheter tube. ​​​

[0065] In one embodiment, and as illustrated in FIGS. 9A-9B, the handle assembly 7 00 includes a proximal sleeve 710, a distal outer gripping portion 720 (including a distal portion 721, a proximal portion 722, and a flange 723 disposed between the distal portion 72 1 and the proximal portion 722), a distal gripping portion sleeve 730, a spring 740, and a chuck 750 (including a distal flange 751 and a proximal portion 752 ). Each of the proximal sleeve 710, the chuck 750, and the distal outer gripping portion 720 includes a through lumen having a cross-sectional area sufficient to allow at least the proximal portion 13 of the catheter 1 to pass therethrough. Further, the proximal sleeve 710 has a second lumen for accommodating a part of the distal outer gripping portion 720 and a third lumen for accommodating a part of the chuck 750. Further, the proximal portion 722 of the distal outer gripping portion 720 includes a second lumen having a diameter for accommodating the chuck 750 (including the flange 751 ). The spring 740 has an axial length smaller than the axial length of the proximal portion 752 of the chuck 750, a diameter larger than the diameter of the proximal portion 752 of the chuck 750, but smaller than the diameter of the distal flange 751 of the chuck 750. The assembled handle assembly 700 is shown in FIG. 9B, but the distal portion 721 of the distal outer gripping portion 72 0 is covered by the distal gripping portion sleeve 730, while the flange 723 remains visible. The proximal portion 752 of the chuck 750 is surrounded by the coil of the spring 740. The chuck 750 and the spring 740 are accommodated inside the second lumen of the distal outer gripping portion 720 and the third lumen of the proximal sleeve 710. The proximal sleeve 71 .

[0066] The assembled handle assembly 700 is shown in FIG. 9B, but the distal portion 721 of the distal outer gripping portion 72 0 is covered by the distal gripping portion sleeve 730, while the flange 723 remains visible. The proximal portion 752 of the chuck 750 is surrounded by the coil of the spring 740. The chuck 750 and the spring 740 are accommodated inside the second lumen of the distal outer gripping portion 720 and the third lumen of the proximal sleeve 710. The proximal sleeve 71 0 0 covers most of the proximal portion 722 of the distal outer gripping portion 720. The short segment 720a proximal to the flange 723 of the distal outer gripping portion 720 is exposed. This configuration shown in FIG. 9B is also referred to as the "locked" position, and by the relative rotation of the proximal sleeve 710 and the distal gripping portion sleeve 730, the advancement or withdrawal of the catheter within the patient's vasculature can be controlled. Such rotation can be achieved by the operator using one hand or both hands. When compared to a known catheter stem where a torque-applying handle is located at a fixed proximal position of the catheter tube, the advantage of the handle assembly of the present invention illustrated herein is that the handle assembly can be easily unlocked or disengaged so that the operator can slide the handle assembly to different positions of the catheter tube, and the handle assembly can be re-locked or re-engaged with the catheter tube. For example, after passing the entire length of the catheter tube through the patient's vasculature, the handle assembly can be unlocked by pulling the proximal sleeve 710 away from the distal outer gripping portion 720. As a result, the exposed section 720b is in an unlocked state larger than the section 720a shown in FIG. 9C. In this unlocked configuration, the handle assembly 700 can be slid as a whole along the entire rail-equipped section of the catheter to a more distal position on the catheter (i.e., further away from the proximal tab 800 and closer to the entry point of the catheter into the patient's body), and the handle assembly 700 can be re-locked by returning to the configuration shown in FIG. 9B. At different positions on the catheter

[0067] When compared to a known catheter stem where a torque-applying handle is located at a fixed proximal position of the catheter tube, the advantage of the handle assembly of the present invention illustrated herein is that the handle assembly can be easily unlocked or disengaged so that the operator can slide the handle assembly to different positions of the catheter tube, and the handle assembly can be re-locked or re-engaged with the catheter tube. For example, after passing the entire length of the catheter tube through the patient's vasculature, the handle assembly can be unlocked by pulling the proximal sleeve 710 away from the distal outer gripping portion 720. As a result, the exposed section 720b is in an unlocked state larger than the section 720a shown in FIG. 9C. In this unlocked configuration, the handle assembly 700 can be slid as a whole along the entire rail-equipped section of the catheter to a more distal position on the catheter (i.e., further away from the proximal tab 800 and closer to the entry point of the catheter into the patient's body), and the handle assembly 700 can be re-locked by returning to the configuration shown in FIG. 9B. At different positions on the catheter positions on the catheter, the handle assembly 700 can be easily unlocked or disengaged so that the operator can slide the handle assembly 700 to different positions of the catheter tube, and the handle assembly 700 can be re-locked or re-engaged with the catheter tube. That is, after passing the entire length of the catheter tube through the patient's vasculature, the handle assembly can be unlocked by pulling the proximal sleeve 710 away from the distal outer gripping portion 720. As a result, the exposed section 720b is in an unlocked state larger than the section 720a shown in FIG. 9C. In this unlocked configuration, the handle assembly 700 can be slid as a whole along the entire rail-equipped section of the catheter to a more distal position on the catheter (i.e., further away from the proximal tab 800 and closer to the entry point of the catheter into the patient's body), and the handle assembly 700 can be re-locked by returning to the configuration shown in FIG. 9B. For example, after passing the entire length of the catheter tube through the patient's vasculature, the handle assembly can be unlocked by pulling the proximal sleeve 710 away from the distal outer gripping portion 720. As a result, the exposed section 720b is in an unlocked state larger than the section 720a shown in FIG. 9C. In this unlocked configuration, the handle assembly 700 can be slid as a whole along the entire rail-equipped section of the catheter to a more distal position on the catheter (i.e., further away from the proximal tab 800 and closer to the entry point of the catheter into the patient's body), and the handle assembly 700 can be re-locked by returning to the configuration shown in FIG. 9B. For example, after passing the entire length of the catheter tube through the patient's vasculature, the handle assembly can be unlocked by pulling the proximal sleeve 710 away from the distal outer gripping portion 720. As a result, the exposed section 720b is in an unlocked state larger than the section 720a shown in FIG. 9C. In this unlocked configuration, the handle assembly 700 can be slid as a whole along the entire rail-equipped section of the catheter to a more distal position on the catheter (i.e., further away from the proximal tab 800 and closer to the entry point of the catheter into the patient's body), and the handle assembly 700 can be re-locked by returning to the configuration shown in FIG. 9B. For example, after passing the entire length of the catheter tube through the patient's vasculature, the handle assembly can be unlocked by pulling the proximal sleeve 710 away from the distal outer gripping portion 720. As a result, the exposed section 720b is in an unlocked state larger than the section 720a shown in FIG. 9C. In this unlocked configuration, the handle assembly 700 can be slid as a whole along the entire rail-equipped section of the catheter to a more distal position on the catheter (i.e., further away from the proximal tab 800 and closer to the entry point of the catheter into the patient's body), and the handle assembly 700 can be re-locked by returning to the configuration shown in FIG. 9B. For example, after passing the entire length of the catheter tube through the patient's vasculature, the handle assembly can be unlocked by pulling the proximal sleeve 710 away from the distal outer gripping portion 720. As a result, the exposed section 720b is in an unlocked state larger than the section 720a shown in FIG. 9C. In this unlocked configuration, the handle assembly 700 can be slid as a whole along the entire rail-equipped section of the catheter to a more distal position on the catheter (i.e., further away from the proximal tab 800 and closer to the entry point of the catheter into the patient's body), and the handle assembly 700 can be re-locked by returning to the configuration shown in FIG. C. In this unlocked configuration, the handle assembly 700 can be slid as a whole along the entire rail-equipped section of the catheter to a more distal position on the catheter (i.e., further away from the proximal tab 800 and closer to the entry point of the catheter into the patient's body), and the handle assembly 700 can be re-locked by returning to the configuration shown in FIG. 9B. In this unlocked configuration, the handle assembly 700 can be slid as a whole along the entire rail-equipped section of the catheter to a more distal position on the catheter (i.e., further away from the proximal tab 800 and closer to the entry point of the catheter into the patient's body), and the handle assembly 700 can be re-locked by returning to the configuration shown in FIG. 9B. In this unlocked configuration, the handle assembly 700 can be slid as a whole along the entire rail-equipped section of the catheter to a more distal position on the catheter (i.e., further away from the proximal tab 800 and closer to the entry point of the catheter into the patient's body), and the handle assembly 700 can be re-locked by returning to the configuration shown in FIG. 9B. 9B. Due to this ability to reposition the handle assembly in place, the handle assembly can be kept close to the patient's body, thereby shortening the distance between the distal tip of the catheter and the location where torque is applied, and as a result, enabling more efficient transmission of torque from the location where torque is applied to the distal tip of the catheter.

[0068] To increase the frictional engagement between the handle assembly and the catheter and to facilitate the transmission of torque from the handle assembly, a portion of the proximal tube portion 13 of the catheter can be modified to have a cross-sectional shape that deviates from the general circular cross-sectional shape. For example, as shown in FIG. 10A, the entire length of a wire or tube (solid or hollow) 13a can be mounted outside a portion of the proximal catheter tube portion 13. The portion of the catheter tube having the mounted wire or tube 13a is also referred to as a "ribbed" section (RS) as described above. The wire or tube 13a can have a size or diameter that is smaller than the proximal catheter tube portion 13, for example, about 5% to about 50% of the diameter of the proximal catheter tube portion 13. Alternatively, the cross-section of the proximal portion of the catheter can be modified so that the proximal portion has a non-circular cross-section, in which case an externally mounted wire or tube may not be required.

[0069] As shown in FIG. 13C, the cross-section of the wire or tube 13a (including 13a1, 13a2, and 13a3) can be circular (13a1) or non-circular, for example, rectangular (13a2) or triangular (13a3)), as well as other shapes such as semi-circular, oval, pentagonal, or hexagonal. It can be in a state. The attachment between the wire or tube (13a1, 13a2, and 13a3) and the catheter tube portion 13 is achieved by performing a shrink wrap (13b1, 13b2, 13b3) that tightly surrounds the wire or tube 13a and the proximal catheter portion 13. The internal lumen of the proximal sleeve 710 of the chuck 750 and the handle assembly can take a corresponding cross-sectional shape in order to correspond to the rail section of the catheter. For example, as shown in FIG. 10B which is a front view of the chuck 750 (the front surface of the flange 751 is visible), the lumen 755 corresponding to the rail section of the catheter is shown to have a shape and size that can slidably conform to the entire cross-sectional shape and size of the rail section, as shown in FIG. 10A. The lumen 755 can also be shaped and sized to slidably conform to any of the cross-sections of the shrink wraps 13b1, 13b2, or 13b3, as shown in FIG. 10C. It can be achieved.

[0070] To correspond to the rail section of the catheter, the internal lumen of the proximal sleeve 710 of the chuck 750 and the handle assembly can take a corresponding cross-sectional shape. For example, as shown in FIG. 10B which is a front view of the chuck 750 (the front surface of the flange 751 is visible), the lumen 755 corresponding to the rail section of the catheter is shown to have a shape and size that can slidably conform to the entire cross-sectional shape and size of the rail section, as shown in FIG. 10A. The lumen 755 can also be shaped and sized to slidably conform to any of the cross-sections of the shrink wraps 13b1, 13b2, or 13b3, as shown in FIG. 10C. For example, as shown in FIG. 10B which is a front view of the chuck 750 (the front surface of the flange 751 is visible), the lumen 755 corresponding to the rail section of the catheter is shown to have a shape and size that can slidably conform to the entire cross-sectional shape and size of the rail section, as shown in FIG. 10A. As shown in FIG. 10A, the lumen 755 corresponding to the rail section of the catheter is shown to have a shape and size that can slidably conform to the entire cross-sectional shape and size of the rail section. As shown in FIG. 10A, the lumen 755 corresponding to the rail section of the catheter is shown to have a shape and size that can slidably conform to the entire cross-sectional shape and size of the rail section. As shown in FIG. 10C, the lumen 755 can also be shaped and sized to slidably conform to any of the cross-sections of the shrink wraps 13b1, 13b2, or 13b3. As shown in FIG. FIG. 10C, the lumen 755 can also be shaped and sized to slidably conform to any of the cross-sections of the shrink wraps 13b1, 13b2, or 13b3. It can be shaped and sized.

[0071] The catheter device of the present invention can be used to facilitate the treatment of CTO lesions, such as in a patient's coronary artery. First, a catheter of the present invention having at least one wing (e.g., having two radially opposed wings) and a side port in the distal tube portion advances in a blood vessel and approaches a CTO lesion (or occlusion) in the artery. Then, the guide tip of the catheter advances distally through the intima of the artery until at least one side port reaches a position within the subintimal space distal to the CTO lesion. In this process, the guide tip causes separation of the layers forming the arterial wall. The catheter of the present invention, having at least one wing (e.g., having two radially opposed wings) and a side port in the distal tube portion, advances in a blood vessel and approaches a CTO lesion (or occlusion) in the artery. Thereafter, the guide tip of the catheter advances distally through the intima of the artery until at least one side port reaches a position within the subintimal space distal to the CTO lesion. In this process, the guide tip causes separation of the layers forming the arterial wall. In this process, the guide tip causes separation of the layers forming the arterial wall. and establish a longitudinal channel extending across the entire CTO lesion. At least one side port can be oriented towards the true vascular lumen. Thereafter, while the guide tip is retained within the subintimal space, a reentry wire or a device having a prebiased distal tip can be introduced into the catheter lumen in a compressed state, and the distal tip of the reentry wire or device can be manipulated to exit at least one side port and enter the true lumen in a natural (uncompressed) state with the aid of fluoroscopy.

[0072] FIG. 11 shows the final stage of this process. In a section of artery 300 having a vascular wall 350, the occlusion 360 separates the vascular lumen into a proximal segment 310 and a distal segment 3 20. The distal tube portion 11 of catheter 1 has advanced into the subintimal space 340, and the proximal side port 6 (as well as the distal side port 7) of the catheter has advanced past the location of the occlusion 360. The radially opposed wings 8a / 8b on the guide tip (such as those shown in FIG. 2A) are circumferentially oriented with the vascular wall 350. Side port 6 faces the distal segment of the vascular lumen 320. The distal tip 17b of the reentry device 17 having a prebiased tip 17a has exited side port 7 and into the distal segment 320 of the vascular lumen with the aid of the radiopaque marker 4. The distal tip 17b of the reentry device enables visualization within the catheter lumen while the distal tip 17b is advancing or retracting a wire, and also enables the operator to visually select a reentry wire and guide it out of the side port from the correct orientation under fluoroscopic guidance. ​​​​​​​​​It can include a material with high radiopacity.

[0073] In the above approach where a reentry device or wire having a preloaded tip is introduced into the true lumen through a side port one or more side ports can be utilized during the reentry operation. For example, for a catheter having two radially opposed side ports and two corresponding radiopaque markers as illustrated in FIG. 2A, the reentry wire can be introduced into the true lumen by a first attempt that penetrates the preloaded tip of the reentry wire through either one of the side ports. If the first attempt is unsuccessful, the reentry wire is withdrawn from that side port and a second attempt is made to manipulate the tip of the reentry device so that it exits through the other side port while maintaining the position and orientation of the catheter's wings. The second attempt is expected to succeed because the orientation of the exit ports is such that one exit port faces towards the true lumen and the other exit port faces in the opposite direction. Such reentry can also be achieved using only one side port. If the first attempt is unsuccessful, the catheter can be rotated approximately 180° within the subintimal space so as to reach another stable position and the reentry is attempted again, which is expected to succeed. The radiopaque markers illustrated in connection with FIGS. 4A and 4B can also be used to determine the orientation of the catheter and side ports for the manipulation of the reentry wire to enter the true lumen.

[0074] The scope of the present invention is not limited by what has been specifically illustrated and described hereinabove. It is not. Those skilled in the art will recognize that there are suitable alternatives to the illustrated embodiments of the configuration, structure, dimensions, and materials. The citation and discussion of the references in this application are presented only for the purpose of clarifying the description of the present invention, and the references are not admitted to be prior art of the invention described herein. All references cited and discussed in this specification are hereby incorporated by reference in their entirety into this specification. Although specific embodiments of the present invention have been illustrated and described, it will be apparent to those skilled in the art that changes and modifications can be made without departing from the spirit and scope of the present invention. The matters described in the above description and the accompanying drawings are provided by way of example only and are not provided as limiting. The citation and discussion of the references in this application are presented only for the purpose of clarifying the description of the present invention, and the references are not admitted to be prior art of the invention described herein. All references cited and discussed in this specification are hereby incorporated by reference in their entirety into this specification. Although specific embodiments of the present invention have been illustrated and described, it will be apparent to those skilled in the art that changes and modifications can be made without departing from the spirit and scope of the present invention. The matters described in the above description and the accompanying drawings are provided by way of example only and are not provided as limiting. The citation and discussion of the references in this application are presented only for the purpose of clarifying the description of the present invention, and the references are not admitted to be prior art of the invention described herein. It is not. Those skilled in the art will recognize that there are suitable alternatives to the illustrated embodiments of the configuration, structure, dimensions, and materials.

Claims

1. A distal tube portion having a distal tip and a longitudinal axis, wherein the distal tube portion comprises a tube wall including at least one side port and at least one radiopaque marker, and at least one wing projecting radially outward from the tube wall. A catheter device comprising the distal tube portion.

2. The catheter device according to claim 1, wherein the at least one wing comprises two wings projecting radially outward in opposite directions.

3. The catheter device according to claim 2, wherein the at least one side port is offset approximately 90° radially from each of the two wings.

4. The catheter device according to claim 2, wherein the at least one side port comprises a first side port and a second side port, the second side port being located distally to the first side port and offset longitudinally and radially from the first side port.

5. The catheter device according to claim 4, wherein the at least one radiopaque marker comprises a first radiopaque marker located longitudinally between the first side port and the second side port, and a second radiopaque marker distal to the second side port.

6. The catheter device according to claim 4, wherein the first side port and the second side port are offset approximately 180° radially from each other.

7. The catheter device according to claim 1, wherein the at least one wing is part of a guide tip engaging the distal end portion of the distal catheter tube portion.

8. The catheter device according to claim 1, wherein the catheter device comprises at least one helical cut, and the at least one side port is located within the helical cut and includes a rim that is not damaged by the helical cut.

9. The catheter device according to claim 1, wherein the catheter device comprises at least two helical cuts having different pitches.

10. The catheter device according to claim 1, wherein the catheter device comprises at least one helical cut having an interrupted helix.

11. The catheter device according to claim 1, further comprising a radiopaque marker fixed on the distal tube portion axially aligned with the at least one side port.

12. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ The catheter device according to claim 1, further comprising an X-ray impermeable marker surrounding the at least one side port. **Claim 13** The catheter device according to claim 1, wherein the at least one side port is chamfered. **Claim 14** The catheter device according to claim 1, wherein the at least one wing is formed of a polymer material. **Claim 15** The catheter device according to claim 1, wherein the at least one wing is formed of metal. **Claim 16** The catheter device according to claim 1, wherein the distal tube portion is formed of stainless steel. **Claim 17** A method for facilitating treatment of an occlusion in a blood vessel having a blood vessel wall defining a blood vessel lumen containing the occlusion by means of a catheter device, comprising the steps of: positioning the catheter device in proximity to the occlusion, the catheter device having a lumen, a tube wall including at least one side port and at least one X-ray impermeable marker, and a guide tip located at a distal end of the catheter, the guide tip including at least two wings radially protruding outwardly in opposite directions, wherein the distal catheter tube portion includes: advancing the guide tip within the blood vessel wall in the vicinity of the occlusion until the at least one side port is positioned distal to the occlusion to establish a flow path within the blood vessel wall extending longitudinally across the entire occlusion; orienting the at least one side port toward the blood vessel lumen; inserting a reentry device through the lumen of the catheter device, the reentry device having a distal end portion in a compressed state; operating the reentry device such that the distal end portion of the reentry device exits from the at least one side port into a distal segment of the blood vessel lumen in a natural state. **Claim 18** The method according to claim 17, wherein the at least one side port includes a first side port and a second side port, the second side port being located distal to the first side port and being displaced longitudinally and radially from the first side port. **Claim 19** The method according to claim 17, wherein the at least one X-ray impermeable marker is located between the first side port and the second side port. **Claim 18** The at least one side port includes a first side port and a second side port, the second side port being located distal to the first side port and being displaced longitudinally and radially from the first side port. **Claim 19** The at least one X-ray impermeable marker is located between the first side port and the second side port. ​ A first radiopaque marker longitudinally positioned between the port and a second radiopaque marker distal to the second side port The method according to claim 17, comprising a second radiopaque marker distal to the second side port.

Images