Vascular Reentry Catheter

Abstract

To provide a vascular re-entry catheter and method for treatment of associated vascular conditions by crossing a CTO in a blood vessel by exploring the 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 the subintimal space. The catheter includes one or more exit ports 6 and radiopaque markers for steering a re-entry wire through one of the exit ports. The catheter includes a number of spiral-cut sections 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 is a continuation of U.S. Provisional Patent Application No. 62 / 050,456, filed September 15, 2014; , which claims priority to U.S. Provisional Patent Application No. 62 / 060,152, filed October 6, 2014. No. 6,299,499, the disclosures of each of which are incorporated herein by reference in their entirety. . [Background technology]

[0002] A chronic total occlusion ("CTO") is a complete or near-complete blockage of a blood vessel, such as a coronary artery. As many as 30% of patients with coronary artery disease have a CTO somewhere along the left or right arterial system. Traditionally, CTOs have usually been treated with bypass procedures, either autologous or synthetic. Synthetic vessels are attached by anastomosis to the vessels at locations upstream and downstream of the occlusive lesion. Although effective, such bypass procedures are quite traumatic for the patient.

[0003] In recent years, catheter-based endovascular procedures have been developed to treat CTOs with success. These procedures include angioplasty, atherectomy, and stent placement. The catheter is usually introduced percutaneously. This has significantly reduced the need for surgery (coronary artery bypass grafting - CABG). In this study, percutaneous coronary intervention (PCI) of the CTO resulted in symptom relief for the patient. This allows coronary blood flow to be re-established, improving left ventricular function and potentially conferring a survival advantage. Peripheral occlusive lesions outside the coronary vascular anatomy may also be treatable with such interventions. is.

[0004] Before such catheter-based treatments can be performed, interventional catheters are usually used. It is necessary to pass a guidewire through the occluded lesion to provide access for the catheter. The available techniques for delivering to the occluded lesion generally involve two approaches: This involves passing a wire from the distal end (either directly through the CTO or through the subintimal space) to the distal end. The antegrade approach and access to the distal cap of the CTO via collateral vessels are also indicated. The latter is usually the second choice in case of failure of intimal antegrade delivery. This is reserved as a measure to

[0005] For CTO treatment with antegrade access PCI, use CrossBoss™ Several different devices have been developed, including the Stingray™ System and the Stingray™ System. http: / / www.bostonscientific.com / en- US / medical-specialties / interventional-ca rdiology / procedures-and-treatments / coron ary-chronic-total-occlusion-system.html( See U.S. Patent No. 8,632,632, last accessed September 10, 2015. 556, 8,202,246, 8,636,712, 8,721,675, 6,511, See 458.

[0006] The CrossBoss™ catheter first inserts a small microinjector into the blood vessel through the obstructed lesion. Use it to facilitate passing the CTO when simply blunt dissecting through the channel If this is not successful, the device penetrates the subintimal space of the vessel wall. By way of example, FIG. 1A shows a CrossBoss™ catheter. 1 shows a schematic diagram of a CrossBoss™ catheter 100, which has a handle 130. a round / flexible proximal shaft 120 that is torquable via rotation; The shaft 120 includes a blunt distal tip 108 and accommodates the guidewire 102. It has a lumen.

[0007] Stingray™ catheters and Stingray™ guidewires are Orienting and guiding a guidewire or reentry device from the subintimal space into the true lumen of the artery Can be used after a CrossBoss™ catheter for ease. Illustratively, FIG. 1B shows a distally positioned laterally inflatable balloon 210 and Stingray with proximal shaft 220 having central guidewire lumen 225 2 shows a schematic diagram of a IV catheter. Side ports 212 and 214 are connected to a balloon 210. are located on either side of a portion of the central lumen disposed laterally, and radiopaque markers 232 and 234. The side ports 212 and 214 are connected to the central guidewire lumen. 225, and the tip of the Stingray™ guidewire re-entry device 240 is By allowing the catheter to exit from one of the ports, the pre-biased tip This facilitates guiding the re-entry device 240 through the endoscopic catheter (at an angle relative to the central lumen).

[0008] The CrossBoss™ catheter rotates the blunt tip to allow for near-CTO access. However, this was not successful. In case of CTO, CrossBoss™ catheter and Stingray This procedure involves the use of both the IV catheter and the IV catheter. It can be explained in a practical way. (1) The CrossBoss™ catheter is inserted between the distal tip of the catheter and the surrounding tissue. Advance the guidewire up to the junction between the (2) Penetrate the catheter tip into the vascular wall and insert the CrossBoss™ device into the vascular wall. The catheter is advanced to form a channel within the vessel wall so that the tip extends longitudinally across the occlusion. Established in the submembrane space, (3) withdraw the CrossBoss™ catheter over the guidewire; (4) Advance the Stingray™ catheter over the guidewire; (5) Inflate the balloon of the Stingray™ catheter to deliver the Stingray™ causing the balloon to assume one of two orientations; (6) withdrawing the guidewire from the Stingray™ catheter; (7) A reentry device having a preconfigured tip in a compressed state is called Stingray (trade name). Advance it into the lumen of the target catheter. (8) The tip of the reentry device is in its natural position in one side of the Stingray™ catheter. Re-enter the artery with the aid of radiography so that it exits the artery port and into the arterial lumen (true lumen). Operate the tip of the device.

[0009] The Stingray™ catheter can then be withdrawn and the re-entry device The proximal segment of the vessel lumen and the distal segment of the vessel lumen remain in place, thereby A pathway from the catheter is established and then introduced into the vascular lumen, followed by a balloon catheter for CT. The stent can be placed at the site O. The stent can also be placed at the site expanded by the balloon. It can be implanted in.

[0010] CrossBoss™ and Stingray™ catheter combination The above procedure of using subintimal delivery is comparable to previous generation techniques in direct antegrade CTO access. Although it overcomes certain drawbacks of the technique, this procedure is complex and time consuming. Switching from ossBoss(TM) to Stingray(TM) can lead to unexpected errors. For example, if a Stingray™ catheter is introduced over a guidewire, The CrossBoss™ catheter is then inserted over the guidewire (so that the catheter can be inserted). Due to the withdrawal, the guidewire may become displaced within the subintimal space or Even worse, it may retreat from the subintimal space, in which case the operator must The ingray™ catheter is properly introduced over the guidewire into the subintimal space. As a result, the CrossBoss It may be necessary to repeat the previous steps using the Stin™ catheter. Advance the gray™ catheter to secure the distal burr of the Stingray™ catheter. When the loons are inflated in the subintimal space, excessive delamination and substantial trauma occur to the vessel wall. This can occur in the layer.

[0011] Explore the subintimal space with a simplified procedure that reduces error rates and trauma to the vessel. Apparatus and method for treating intravascular CTO-related vascular conditions by studying the It would be desirable to provide Summary of the Invention

[0012] In one embodiment, the present invention provides a catheter device. a tube wall having an axis and including at least one side port; at least one radiopaque mark; and a distal catheter including at least one wing projecting radially outward from the vessel wall. Includes the ter tube section.

[0013] In some embodiments, the tube wall has two walls that project radially outward in diametrically opposed directions. In some of these embodiments, at least one side port includes two In certain embodiments, the first wing is radially offset by approximately 90° from each of the first wings. The first side port and the second side port are radially offset from each other by approximately 180°. do.

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

[0015] In some embodiments, the catheter device includes at least one side port and an axial In another embodiment, the catheter includes a radiopaque marker affixed to the distal catheter tube that matches the The catheter device includes a radiopaque marker surrounding at least one side port. Includes.

[0016] In some embodiments, the tube wall is longitudinally and radially spaced from the first side port. a second side port offset from the first side port, the second side port , located distal to the first side port. In some of these embodiments, the vessel wall a first radiopaque mask positioned longitudinally between the first side port and the second side port; and a second radiopaque marker distal to the second side port.

[0017] In some embodiments, at least one wing is adapted to engage the distal end of the catheter. In another embodiment, at least one wing is a part of the guide tip. The probe may be located within a distance from the distal end of the probe.

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

[0019] In certain embodiments, the catheter device includes at least two catheters having different pitches. Includes a spiral cut.

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

[0021] In certain embodiments, the catheter device includes at least two catheters having different pitches. It includes an interrupted spiral cut.

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

[0023] In another aspect, the present invention provides a catheter device as described herein for detecting a blood vessel. The present invention provides a method for facilitating treatment of an occlusion in a blood vessel, the method comprising: The occlusion separates the vessel lumen into a proximal segment and a distal segment. The catheter device has a lumen and includes 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] 1 shows a schematic representation of a CrossBoss™ catheter, as known in the art. [Figure 1B] FIG. 1B illustrates a schematic diagram of a Stingray™ catheter, which is known in the art. [Figure 2A] 1 shows a catheter (tube) with a guide tip having wings and a side port in the spiral cut, according to one embodiment of the present invention. [Figure 2B] 2B shows a front view of the guide tip of the catheter shown in FIG. 2A. [Figure 2C] FIG. 2B is a side cross-sectional view of a portion of the catheter shown in FIG. 2A. [Figure 2D] FIG. 1 is a front view of a guide tip having wings, according to one embodiment of the present invention. [Figure 2E]FIG. 10 is a front view of a guide tip having wings according to another embodiment of the present invention. [Figure 2F] 10 is a side cross-sectional view of a portion of a catheter having a winged guide tip in accordance with another embodiment of the present invention. [Figure 2G] FIG. 10 is a side cross-sectional view of a portion of a catheter having distal wings according to another embodiment of the present invention. [Figure 3A] 2C is a photograph of the tip of a guide such as that illustrated in FIGS. 2A and 2B. [Figure 3B] FIG. 2C is a rear view of the guide tip as illustrated in FIGS. 2A and 2B. [Figure 3C] 3B is a cross-sectional view of the guide tip taken along line AA shown in FIG. 3A. [Figure 3D] 3B is a cross-sectional view of the guide tip taken along line BB shown in FIG. 3A. [Figure 3E] FIG. 10 is a cross-sectional view of a guide tip according to another embodiment of the present invention. [Figure 3F] 1 illustrates an exemplary side cross-sectional wing shape according to some embodiments of the present invention. [Figure 3G] FIG. 10 is a front view of a guide tip having three or more wings, according to some embodiments of the present invention. [Figure 3H] 1A-1C are front views of guide tips having anisotropic transverse cross-sectional shapes according to some embodiments of the present invention. [Figure 4A] 1 is a schematic side view of a catheter having radiopaque markers, according to some embodiments of the present invention; [Figure 4B] 1 is a schematic side view of a catheter having radiopaque markers, according to some embodiments of the present invention; [Figure 5A] FIG. 1B is a top view of a chamfered port on a spiral cut of a catheter, according to one embodiment of the present invention. [Figure 5B] FIG. 5B is a side cross-sectional view of a chamfered port as shown in FIG. 5A. [Figure 6] 10A-10C illustrate a catheter including multiple spiral cuts on the distal catheter tube, according to some embodiments of the present invention. [Figure 7A] FIG. 1 is a side view of a spiral cut of a catheter including an interrupted helix, according to one embodiment of the present invention. [Figure 7B] 1 illustrates a portion of a catheter having an interrupted spiral cut pattern in an extended state according to one embodiment of the present invention. [Figure 8A] 10A-10C are photographs of different spiral cut sections of a catheter according to one embodiment of the present invention. [Figure 8B] 10A-10C are photographs of different spiral cut sections of a catheter according to one embodiment of the present invention. [Figure 8C] 10A-10C are photographs of different spiral cut sections of a catheter according to one embodiment of the present invention. [Figure 8D] 10A-10C are photographs of different spiral cut sections of a catheter according to one embodiment of the present invention. [Figure 9A] FIG. 10 is an exploded view of components of a handle assembly for use with a catheter, according to some embodiments of the present invention. [Figure 9B] 9B illustrates the handle assembly from the components shown in FIG. 9A when assembled in a first configuration. [Figure 9C] 9B shows the handle assembly from the components shown in FIG. 9A when assembled in a second configuration. [Figure 10A] 1 illustrates a configuration of a proximal portion of a catheter, according to some embodiments of the present invention. [Figure 10B] FIG. 9B is a front view of the components of the handle assembly shown in FIG. 9A. [Figure 10C] 10A-10C illustrate various cross-sectional configurations of a proximal portion of a catheter, according to some embodiments of the present invention. [Figure 11] 10 illustrates the configuration of a catheter after passage from the subintimal space through a CTO lesion and a re-entry device re-entering the vessel lumen through a side port of the catheter, according to some embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0025] In one embodiment, the present invention provides a catheter device (or catheter). The catheter is passed through the CTO either directly or via the subintimal space. In another aspect, the present invention provides a method for treating CTO. The present invention provides a method for treating

[0026] As illustrated in FIGS. 2A and 2B, a catheter device 1 according to one embodiment of the present invention is The distal end of the distal tubular portion 11 includes a tubular wall 10 and a distal tubular portion 11 having a longitudinal axis L. On the distal end 101 of the catheter 1 is a blunt guide tip (or tip) 3. A blunt guide tip (or tip) 3 surrounds the distal end portion of the distal tube 11 . The guide tip 3 has a base portion 3a and a radially outwardly projecting portion 3b extending from the periphery of the tip 3. In a particular embodiment, the guide tip 3 comprises two outer wings 8a and 8b. The wing may have fewer or more wings, e.g., one wing, as described herein. It may contain only one wing or more than two wings.

[0027] When two wings are present, the wings are angled at about 30 to about 90 degrees, or about 90 to about 90 degrees. They may be radially separated or offset by approximately 180° or any fraction thereof. For example, the angle can be about 30°, about 60°, about 90°, about 120°, about 150°, or Or, it can be about 180°. As shown in FIGS. 2A and 2B, in some embodiments In the figure, two wings 8a and 8b are arranged opposite to each other around the guide tip. The angle can be positioned approximately diametrically from 180° ± 10°, more preferably about ± 5°. do.

[0028] Figure 2C shows a cross-sectional view of a portion of the tube 1 of Figure 2A along the longitudinal axis L. As shown in FIG. 1, the outer diameter of the guide tip ODt (not including the wings) is 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 base width Wb, which is the height measured from the OD to the highest point of the wing. The leading edge of the wing is generally rounded, i.e., smooth.

[0029] As shown in FIG. 2B, the guide tip 3 may, in certain embodiments, be positioned around the periphery of the distal tube 11. In an alternative embodiment, and as shown in FIGS. 2D and 2E, As shown, the guide tip 3 (including the base 3a and wings 8a / 8b) is For example, the guide tip 3 does not completely surround the distal tube 11. , 2 / 3, 1 / 4, or smaller percentages. 2E, the guide tip 3 is positioned along the periphery of the distal tube 11. The base portion may comprise a plurality of separate base portions (3a, 3b) distributed over the entire surface.

[0030] In a particular embodiment, the guide tip 3 with wings 8a and 8b is Some distance from the distal end 101, for example, 1 to about 100 mm (see FIG. 2F), about Position at a distance dw, for example, in the range of 10 mm to about 75 mm, or about 25 to about 50 mm. It can be decided.

[0031] In certain embodiments, one or more wings are supported by a terminal base portion. without being held, for example, at the distal end 101 and / or away from the distal end 101 As illustrated in FIG. 2G, wings 8a / 8b can be attached directly to the distal The distal end of the distal tube 11 is not part of the tip surrounding the tube 11 (e.g., by welding, In this situation, the wing itself is also It can be considered the only component of the tip of the rod.

[0032] Depending on the material and structural requirements in terms of flexibility, the thickness of the tube wall 10 may be, for example, about 0. 0.02 inches to about 0.02 inches, about 0.05 mm to 2 mm, e.g., 0.05 mm to about 1mm, about 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, It can be changed to 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1.0mm, etc. The inner diameter (ID) of the lumen of the distal tubular section 11 can be, for example, from about 0.01 inches to about 0. 0.4 inches, or from about 0.1 mm to about 2 mm, or from about 0.25 mm to about 1 mm, for example, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm mm, can be changed to about 0.7mm, about 0.8mm, about 0.9mm, about 1mm, etc. The outer diameter (OD) of the lumen of the distal tube portion may also be, for example, about 0.2 mm to about 3 mm, e.g., Approx. 0.2mm, approx. 0.3mm, approx. 0.4mm, approx. 0.5mm, approx. 0.6mm, approx. 0.7m m, approx. 0.8mm, approx. 0.9mm, approx. 1mm, approx. 1.1mm, approx. 1.2mm, approx. 1.3m m, approx. 1.4mm, approx. 1.5mm, approx. 1.6mm, approx. 1.7mm, approx. 1.8mm, approx. 1. The thickness of the tube wall, the inner diameter (ID) and the outer diameter (OD) can vary from 9mm to about 2.0mm. can each be constant throughout the length of the catheter, or It can vary along its length.

[0033] In certain embodiments, the wing height Hw is about 5% to about 5% of the outer diameter ODt of the tip 3. 0% (including about 10% to about 40%, about 15% to about 30%, or about 20%) Alternatively, the wing height Hw can be about 10% to about 15% of ODt, or about 15%. In some embodiments, the range may be from about 5% to about 45%. The bottom width Wb of the wing can be set to about 5% to 30% of the outer diameter ODt of the tip 3. The axial length of the base of the guide can be made approximately 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 The width of the wing can range from 10 mm to 12 mm, or about 10 mm. The axial length of the base portion can be made smaller than the axial length Lt of the guide tip 3.

[0034] The vessel wall 10 and guide tip 3 may be made of metal, polymer, or composite materials. Suitable metals include cobalt chrome, stainless steel, MP35N, nickel titanium, and metal alloys such as shape memory materials, for example, Nitinol. The pipe wall is made of aliphatic polyether urethane, polyamide, low density polyethylene (LDP) E) The tube wall may be made of a polymer such as polypropylene or a mixture of polymers. The distal tube section may also comprise a metal and polymer composite that is bonded or abutted to form a generally tube-like structure. The distal catheter tube may be formed of a polymer and metal composite, such as a metal composition. The guide tip 3 and / or wings may be made of metal, for example stainless steel. 8a / 8b can be made of the same material as the pipe wall or a different material. For example: The guide tip may include a radiopaque material, such as a radiopaque filler composition. The materials used in rain gauges vary from soft rubber-like materials to hard composite polymers or plastics. The wings may include metal and softer outer components such as polymers. The wings may be made from the same or different material as the rest of the tip. For example, the wings may be made from a polymer. -material, shape memory material such as Nitinol, or metal such as Cobalt Chromium obtain.

[0035] FIG. 3A shows a gas turbine including two wings 8a and 8b extending from the top and bottom, respectively. The left side of the guide tip 101 is a micrograph of the catheter as previously described. FIG. 3B shows a rear view of the guide tip. FIG. 3C shows a FIG. 3D is a cross-sectional view of the tip 3 along line AA in FIG. 3B (of the wings 8a / 8b). 3B along line BB, showing the base portion having a rounded leading edge 102. The leading edge may alternatively include a tapered portion 103 as shown in FIG. 3E. The blade portion 103 may be smooth, i.e., have a blunt cutting edge, allowing for control of blunt microdissection. It is possible.

[0036] The peripheral contour of the wing along the axial direction is generally convex in shape, e.g., a smooth longitudinal It can be in the form of a circular curve (see Figures 2A / 2C / 3A / 3C). In an embodiment, and as illustrated in FIG. 3F, the side profile or shape of the wing is: The corners of the rectangle (111), trapezoid (113), or rounded shape (112 and 113, respectively) 4) or may be rectangular or trapezoidal, or sinusoidal (115).

[0037] More than two wings may be positioned around the periphery of the guide tip 3. For example, The number of wings may be evenly or unevenly positioned along the periphery, symmetrically or They can be asymmetrically positioned. Multiple wings can be identical in shape and / or size. As shown in Figure 3G, there are eight wings (8a, 8b, 8c, 8 d, 8e, 8f, 8g, 8h) are located at or near the distal end of the distal tube section The lateral cross-section of these wings (perpendicular to the axial direction of the distal tube) is shown in the figure. The size and shape can vary (e.g., generally bell-shaped, arc-shaped, with rounded corners). The outer surface of the wing usually forms a smooth transition with the outer wall of the tip.

[0038] In certain embodiments, the wings may 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 8a and 8b protrude outward due to the anisotropic transverse cross-sectional shape of the guide tip 3. In some embodiments, the maximum cross-sectional width of the guide tip 3 (which can be considered as the "wing length"); D1 is greater than the minimum cross-sectional width D0 of the guide tip 3. For example, D1 is greater than D0. It can be about 10% to about 500%, for example, about 50% to about 200% larger. In this embodiment, D1 is the outer diameter (O) of the distal tube section where the guide tip is to be engaged. D) Approximately equal to the inner diameter of the tip) %, 150%, 200%, 250%, or 300% greater.

[0039] The guide tip 3 (optionally with wings) is attached to the vessel wall 10. or otherwise attached to the distal end of the distal tube portion 11. The wings can be made as an integral part of the tip 3 or can be attached to the The ring is fused onto the base of the tip 3 by mechanical bonding (e.g., friction), adhesive bonding, chemical bonding, etc. The components may be joined or otherwise combined.

[0040] Catheter 1 is a microcatheter having one lumen for use in conjunction with a guide catheter. The catheter 1 may also have two or more lumens, e.g., a lumen It may have two, three, four, or five lumens surrounded by a 0. Lumen The lumen may have equal or unequal inner diameters. A navigable guidewire can be connected to the balloon. The catheter can be inserted through the lumen of the catheter. The catheter wall thickness can be designed to optimize parameters such as catheter length and transition. The flexibility of the ether can be varied along its length as needed or desired. The thickness may vary along its length.

[0041] As shown in FIGS. 2C and 2F, the tube wall 10 does not reduce the flexibility of the distal tube portion 11 and at the same time The jacket 10 may be covered with a protective jacket 10a to provide a smooth outer surface. a is a polymer, for example, a single or multiple layer coextruded polymer tubular structure and The tube wall 10 is surrounded by heat which shrinks the tubular structure or through a dip coating process. The polymer jacket material can be made by coating the pipe wall 10 with a Iron, polyether block amide, PTFE, FEP, PFA, PET, PEEK, etc. Furthermore, the distal tube 11 (or the entire length of the catheter 1) can be It may be coated with a hydrophilic polymer coating to enhance its properties. The polymer may comprise a polyelectrolyte and / or a non-ionic hydrophilic polymer. The electrolyte polymers are poly(acrylamide-co-acrylic acid) salts, poly(methacrylic acid) Poly(acrylamide-co-acrylic acid) salts, poly(acrylamide-co-methacrylic acid) salts, etc. The non-ionic hydrophilic polymer may include a poly(lactam), e.g., a polyvinylpyrrolidone. lolidone (PVP), polyurethane, homopolymers and copolymers of acrylic and methacrylic acid Polymers, polyvinyl alcohol, polyvinyl ether, maleic anhydride copolymers, Polyester, hydroxypropyl cellulose, heparin, dextran, polypeptide For example, U.S. Patent No. 6,458,867 and U.S. Patent No. 8,871,878 See 69.

[0042] FIG. 2A also shows a distal catheter 100, which facilitates radiographic imaging of the positioning of the catheter 1 within the vessel lumen. Two radiopaque markers 4 and 5 are shown positioned along the tube 11. The ka is made of metals such as platinum, platinum-iridium, tantalum, and gold in the form of wire coils or bands, and X-ray Opaque materials, vapor deposition deposits, and radiopaque powders or fillers, e.g., polymeric bases Barium sulfate, bismuth trioxide, bismuth subcarbonate, etc. embedded or enclosed in the material Alternatively, the marker may be made of a radiopaque polymer, such as a radiopaque polyurethane. The marker can be made by attaching the outer sheath tube of the distal tube portion 11 to the outer sheath tube as shown in FIG. 2A. It may be in the form of an encircling band.

[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. In this way, the two wings 8a / 8b can be stabilized in the subintimal space of the artery. When positioned in this configuration, the port 6 faces toward the true lumen of the artery or Alternatively, the port 7 may be positioned facing the lumen, and the port 7 may be positioned facing the opposite side. Cut.

[0045] The side ports may be symmetrical in shape and may be circular, semicircular, oval, semi-oval, rectangular, or The ports may be semi-rectangular. The ports may have the same shape and size (i.e., surface area). or can be different from each other, and the reentrant wires through the ports or The port is configured to allow passage of another medical device. Diameters range from 5mm to approximately 1.0mm to accommodate different types of medical devices or wires. [Eurointervention 2010:6, 1-8. The distal tube portion 11 may have three or more outlet ports, e.g., It accommodates 3, 4, 5, 6, 7, 8, ... n ports along the direction, allowing for desired The particles can be dispersed radially rather than in a circular arc.

[0046] The radiopaque marker configured as a band shown in FIG. 2A has a distal tube portion 11 that is in contact with the subject's Used to facilitate determination of the location of the side port while manipulating the anatomy. As shown in FIG. 4A, markers 4a and 5a (marker 5a is attached to the tube 11) and thus hidden from view as shown) may also be It may be configured as a partial band or patch that forms a specific match with the corresponding side port. For example, as shown in FIG. 4A, the marker 4a is axially aligned with the side port 7. marker 5a is axially aligned with the side port 6. Like the radially opposed configuration of ports 6 and 7, markers 4a and 5a are also In this way, the visualization of the markers 4a and 5a is The markers can be used to determine the orientation of each side port. To facilitate the determination of orientation, different shapes, e.g., partial circumferential bands, or can be configured in any other desired shape.

[0047] As shown in FIG. 4B, the markers are arranged around the periphery of each of the outlet ports 7 and 6. Constructed as surface patches 4b (hidden from view, indicated by dashed borders) and 5b In such an embodiment, the visible marker position is the side position. It corresponds directly to the port position.

[0048] In FIG. 4A or FIG. 4B, the markers are visualized with the aid of appropriate radiography. The device should be of sufficient size and suitable construction / structure (e.g., made of a radiopaque material) so that it can be type, radiopaque material loading, etc.)

[0049] Also shown in FIG. 4A are further wings 8c and 8d, with further wing 8c and 8d are proximal to the side port 6 (wings 8a and 8b are adjacent to the side port 6). The radiopaque material may also be located within wings 8a, 8b and / or 8c, 8d. These wings also help visualize the location of the side ports. The catheter can function as an X-ray opaque marker so that the catheter Other configurations of radiopaque markers for determining device orientation may also be used. 092512A1, U.S. Patent No. 8,983,577, and U.S. Patent Publication No. 201 Please refer to 40180068.

[0050] In some embodiments, the side port 6 (or 7) is shown in FIG. 5A (perspective view) and FIG. The side port may be chamfered as shown at B (side cross-sectional view taken along line BB in FIG. 5A). The beveled configuration of the side port allows the re-entry wire 17 with its bent tip to smoothly exit and 5B). 5B) can be from 10° to about 90°, from about 20° to about 70°, or from 40° to about It can range from about 0° to about 90°, inclusive of 60°.

[0051] The configuration of the distal tubular portion 11 of the catheter 1 shown in FIGS. 2A to 2G is such that the catheter 1 is inserted into the subintimal space. The advancement of the guide tip 3 allows it to be used as an effective handover device through the exploration. This can be achieved by rotating the proximal portion of the catheter, which allows, for example, As further described below, a torque applying device coupled to the outer sheath of the catheter tubing. Torque applied by the ball handle is transmitted to the guide tip 3. The outer wing 8a in the subintimal space and 8b rotational advancement creates a controlled wide cut or The tip produces more effective delamination of vascular layers than a symmetrical blunt tip due to the presence of a cutting surface. Furthermore, the outwardly extending wings 8a / 8b can be used to hold the catheter 1 in place. This can facilitate orientation within the submembrane space, thereby providing a radiopaque marker and In conjunction with the side port, the catheter 1 can also serve as an orientation device. A pre-energized re-entry wire or other type of re-entry device may be inserted into one of the side ports. Manipulation and exiting the catheter from the endoscopic catheter to the true lumen with the aid of radiographic imaging (e.g., fluoroscopic radiography) We can provide guidance.

[0052] As shown in FIGS. 2A and 2C, the wall 10 of the distal tube portion 11 of the catheter 1 is It may include a section including a spiral cut 15 progressing around the axis L. The cuts are made by using a laser, for example a femtosecond solid-state cutting laser, to separate the tubing material from the tubing wall. The tube portion having the spiral cut can also be removed by A ribbon or flat carp (made from the remaining wall of the tube) wound in a spiral around It can be seen as a

[0053] The spiral cut of the catheter allows for direct use within the vascular system and allows for the catheter to be inserted into the outer jacket. Alternatively, the spiral cut may be as shown in Figure 1. 2C and 2F, the jacket 10a may cover the Also, as shown in FIG. 5A, when positioned within the spiral cut of the distal tube portion 11, , the port 6 is not damaged by the spiral cut 15 (in other words, the spiral cut 1 5 may have a solid rim 61 (not cutting through the edge of the side port 6). As shown in FIG. 5B, when the pipe wall is covered with a jacket 10a, the outer jacket 10a The side port must be positioned so as not to prevent the re-entrant wires from exiting or retracting from the side port. It can be sufficiently removed around the

[0054] The catheter has several different spiral cut patterns, including continuous and discontinuous. The spiral cut is designed to provide a gradual transition in bending flexibility. For example, a spiral cut pattern may be present in one or more regions. The pitch of the spiral cut may vary to increase flexibility. It can be measured by the distance between points at the same radial position within the thread. In an embodiment, the pitch is determined by the length of the spiral cut as it progresses from the proximal position to the distal end of the catheter. In another embodiment, the pitch may increase as the spiral cut extends along the length of the catheter. The catheter may decrease in volume as it progresses from its proximal position to the distal end of the catheter. The distal end of the tube can be more flexible. By adjusting the pitch of the spiral cut, The catheter's pushability, kink resistance, torque, flexibility, and compression resistance can be adjusted. Cut.

[0055] Spiral cuts with different cut patterns distributed along the length of the catheter The spiral cut pattern may be continuous or discontinuous along the length of the catheter. For example, 1, 2, 3, 4, 5, 6, 7, ..., n spiral cuts can be There may be indentations along the length of the catheter, with a consistent indentation pattern within each indentation. There may be pins, but across the different cuts the cut pattern may be, for example, pins. Each cut also has a variable pitch pattern for that particular cut. Each spiral cut can be, for example, about 0.05 mm to about 10 mm, e.g. For example, 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0 .7mm, 0.8mm, 0.9mm, 1.0mm, 1.5mm, 2.0mm, 3.0mm The pitch may be in the range of 1.5 mm, 2.5 mm, 3.5 mm, 4.0 mm, etc. The pitch may also be The pitch of different spiral cuts may be the same or different. Alternatively, the catheter may have a continuously varying spiral cut pattern. The orientation or winding direction of the spiral cut in the catheter may also be It may also vary between spiral cuts.

[0056] a distal tube section including three continuous spiral cuts S1, S2, and S3 along its length; As shown in FIG. 6, the catheter 1 has a cutout S1. 1, a guide tip 3 at the distal end 101 of the catheter, as well as two radii The side ports 6 and 7 may be longitudinally offset in opposite directions. All spiral cuts are made from the same tube (e.g., hypotube) with a consistent diameter. The distal tube portion 11 can also have a spiral cut portion S3 without a proximal cut. The catheter 1 further includes a proximal tube portion 13. 3 may be made from the same tube as the distal tube portion 11 or may be constructed from a different tube to The proximal tube 13 can be joined to the proximal end of the catheter 1. 800 and is connected to a handle assembly, i.e., a torque The proximal tube 13 also extends through the applicator 700 for engagement with the handle assembly 700. Sections RS with non-circular cross-sectional shapes (as will be described later, "railed" sections) (also referred to as "common name").

[0057] Each of the spirals S1, S2, and S3 has dimensions and flexibility suitable for the intended use of the catheter. For example, the length and pitch of each spiral may be Performance requirements for performing a specific procedure, such as a PCI procedure (e.g., the ability to access the treatment site) The catheter may be selected based on its diameter, length, shape, and other configurations of the vascular system through which it will be advanced. For example, in one embodiment, the spiral portion S1 has a length in the range of about 10 cm to 15 cm, and The spiral portion S2 may have a pitch in the range of about 0.5 mm to about 1.0 mm. The length may range from 4 to 6 cm, and the pitch may range from about 1 to about 2 mm. The turning portion S3 has a length in the range of about 0.5 cm to 2 cm and a width in the range of about 0.05 mm to about 0.3 mm. The pitch can be in the range of

[0058] The spiral cuts exemplified above are continuous at the spiral cut portion. The spiral cut is an interrupted spiral, i.e., a spiral that includes cut and uncut portions. As illustrated in Figures 7A and 7B, the ribbon 12 may include a spiral pattern. The spirally cut tube section S11 of the catheter is substantially defined by an interrupted spiral 16. The interrupted spiral 16 has adjacent turns 14 that are fixed and separated, and alternately open or cut. The alternating notched and non-notched portions 18 and 20 are included. The paths 8 and 20 are oblique to the periphery of the tube (in other words, the pitch shown in FIG. 7B). The angle φ is less than 90°. Due to the presence of the uncut portion 20, the pipe portion more resistant to stretching than a wound ribbon or a tube with a continuous spiral 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 Nc can also be designed to include Integers such as 2, 3, 4, 5, …, n, as well as 2.2, 2.4, 2.7, 3.1, It can be any other real number, such as 3.3. For a given Nc, the no-cut range α and the cut range The cut-in range β is determined by the rotation of the cut-in part of the range β near the cut-out part of the range α. α=(360-(β * Nc)) / Nc For example, when Nc=1.5, 2.5 and 3.5, the following table shows the values ​​of α and 10 shows an exemplary selection of various embodiments for β and β. TIFF0007757366000001.tif159164

[0062] 8A-8D show interrupted spirals with different pitches as described herein. 1 is a photograph of a section of a tube having a notch.

[0063] The catheter of the present invention has a series of spiral cuts arranged in any order (Fig. 2A, 2C, 2F, and 6), interrupted spiral cuts (Figs. 7A-7D). 7C), or a mixture of both types of spiral cut patterns. It can be done.

[0064] To facilitate lateral positioning of the distal portion of the catheter tube 1 within the subject's blood vessel, A torque applying device (i.e., a handle assembly) is provided that is attached to the proximal portion of the tertube. The handle assembly can accommodate the catheter tube and can also be used to The handle assembly is frictionally engaged with the handle tube to apply torque when a portion of the handle assembly is rotated. The catheter may include a lumen or internal opening for receiving the catheter.

[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 that houses a portion of the distal outer gripping portion 720 and a third lumen that houses a portion of the chuck 750. Further, the proximal portion 722 of the distal outer gripping portion 720 includes a second lumen having a diameter for housing 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. Shown in FIG. 9B is the handle assembly 700 when assembled, with the distal portion 721 of the distal outer gripping portion 72 0 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 coils of the spring 740. The chuck 750 and the spring 740 are housed 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

[0066] 0 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 coils of the spring 740. The chuck 750 and the spring 740 are housed 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 0 covers most of the proximal portion 722 of the distal outer gripping portion 720. The short segment 720a proximal to the flange 723 is exposed. This configuration, also referred to as the "locked" position, allows the proximal sleeve 710 and the distal gripper sleeve 730 relative rotation to control advancement or withdrawal of the catheter within the patient's vascular system. Such rotation can be performed using one hand or using both hands. This can be achieved by the radar.

[0067] A known catheter system in which the torque handle is located at a fixed proximal position on the catheter tube. The advantage of the handle assembly of the present invention as illustrated herein compared to a stem is that the handle assembly The handle assembly allows the operator to slide the handle assembly to different positions on the catheter tube. The handle assembly can be easily unlocked or disengaged to allow for easy access. The advantage is that it can be locked or re-engaged with the catheter tube. For example, after the entire length of the catheter tubing has been threaded through the patient's vascular system, the handle assembly may be Unlock by pulling the proximal sleeve 710 away from the proximal outer grip 720. 9C, resulting in exposed section 720b. In this unlocked configuration, the section is larger than that of 20a. The handle assembly 700 generally fits along the entire railed section of the catheter. , at a more distal location on the catheter (i.e., further away from the proximal tab 800 and closer to the patient's body). The handle assembly 700 can be slid to the catheter entry point (closer to the catheter entry point) and the handle assembly 700 can be moved to the It can be relocked by returning to the configuration shown in 9B. This ability to reposition the handle assembly on a point allows the handle assembly to be attached to the patient's body. This allows the catheter to be held close to the distal tip and torque to be applied. The distance to the point where the catheter is inserted is shortened, resulting in a torque being applied to the distal tip of the catheter. This allows for more efficient transmission of torque from a point.

[0068] To increase the frictional engagement between the handle assembly and the catheter, and To facilitate torque transmission from the catheter, a portion of the proximal tubular section 13 is generally It can be modified to have a cross-sectional shape that deviates from a circular cross-sectional shape. As shown in 10A, the entire length of the wire or tube (solid or hollow) 13a is The wire or tube 13a may be attached to the outside of a portion of the wire or tube 13a. The catheter tubing section also has a "railed" section ( The wire or tube 13a is smaller than the proximal catheter tube section 13, e.g. , and may have a size or diameter that is 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 may be such that the proximal portion has a non-circular cross section. can be modified to fit the externally attached wires or tubes. could be.

[0069] As shown in FIG. 13C, wires or tubes 13a (including 13a1, 13a2, and 13a3) The cross section of the casing (including the casing) may be circular (13a1) or non-circular, e.g. rectangular (13a2) or triangular. (13a3)), as well as other shapes such as semicircular, oval, pentagonal, or hexagonal shapes. The wires or tubes (13a1, 13a2, and 13a3) and the catheter The attachment between the wire or tube 13a and the proximal catheter section 13 is performed by firmly securing the wire or tube 13a and the proximal catheter section 13. This is achieved by shrink-wrapping the product (13b1, 13b2, 13b3) around the product. can be done.

[0070] Chuck 750 and handle assembly to accommodate railed sections of catheter The inner lumen of the proximal sleeve 710 of the bridge can have a corresponding cross-sectional shape. For example, FIG. 10B is a front view of chuck 750 (showing the front of flange 751). As shown, a lumen 755 corresponding to the railed section of the catheter is provided as shown in FIG. As shown in A, the railed section is slidably fitted to the overall cross-sectional shape and size of the railed section. The lumen 755 is also shown as having a shape and size that allows for As shown in FIG. 1C, the cross section of any of the shrink wraps 13b1, 13b2, or 13b3 The suction cup may also be shaped and sized to slidably fit within the suction cup.

[0071] The catheter device of the present invention facilitates the treatment of CTO lesions, such as in the coronary arteries of a patient. First, at least one wing (e.g., two halves) a guide tip having radially opposed wings and a side port in the distal tube The catheter of the present invention is advanced in a blood vessel and removes a CTO lesion (or blockage) in an artery. Then, the guide tip of the catheter is positioned so that at least one side port is in the CT Advance through the intima of the artery in a distal direction until reaching a location within the subintimal space distal to the lesion In this process, the guide tip causes the separation of the layers that form the wall of the artery. and establish a flow path that extends longitudinally across the CTO lesion. The guide port can be oriented toward the true vessel lumen. Then, the guide tip is inserted into the subintima. While being held within the space, the re-entrant wire or the pre-biased distal tip The device is introduced into the lumen of the catheter in a compressed state and the re-entry wire or distal tip of the device is inserted. At least one side with the edge in its natural (uncompressed) state with the aid of radiography It can be manipulated to exit the port and enter the true lumen.

[0072] Figure 11 shows the final stage of this process. A section of artery 300 with vessel wall 350 is In this case, the occlusion 360 separates the vessel lumen into the proximal segment 310 and the distal segment 312. The distal tubular portion 11 of the catheter 1 has been advanced into the subintimal space 340. The proximal side port 6 (and distal side port 7) of the catheter is positioned at the occlusion 360. The radial direction on the guide tip (such as that shown in Figure 2A) has been advanced past the position The opposing wings 8a / 8b are oriented circumferentially with the vessel wall 350. 6 faces the distal segment of the vessel lumen 320. The distal tip 17b of the re-entry device 17 is positioned at the side port 7 with the aid of the radiopaque marker 4. and exiting the distal segment 320 of the vessel lumen. 17b is used to advance or withdraw the wire while the distal tip 17b is This allows the operator to select the re-entry wire and visualize it within the lumen. Fluoroscopic guidance allows for visual guidance out of the side port from the correct orientation The material may include a highly radiopaque material.

[0073] A re-entry device or wire with a pre-biased tip is inserted into the true lumen through a side port. In the above approach, one or more side ports are implemented for reentrant operations. For example, two radially opposed side poles as illustrated in FIG. 2A may be used. For a catheter with a port and two corresponding radiopaque markers, the re-entry wire is A first wire is inserted through the pre-biased tip of the re-entry wire via one of the side ports. If the first attempt is unsuccessful, a re-entry wire may be introduced into the true lumen. The catheter is withdrawn from its side port, maintaining the position and orientation of the wings. A second attempt is made to manipulate the tip of the re-entry device so that it exits the other side port. The second trial was conducted by orienting the outlet ports so that one of the outlet ports was facing the true lumen. , the other exit port is facing the opposite direction, so it is expected to be successful. Such reentrancy can also be achieved using only one side port, If one attempt is unsuccessful, the catheter should be moved to another stable position to allow the subintimal void to be reached. The re-entry is attempted again, and this may be successful. The radiopaque markers illustrated in connection with FIGS. 4A and 4B are also expected to be true internal Determining catheter and side port orientation for maneuvering a re-entry wire to enter the cavity can be used for

[0074] The scope of the present invention is not to be limited by what has been particularly shown and described hereinabove. Those skilled in the art will appreciate that suitable substitutions may be made to the illustrated examples in terms of configuration, construction, dimensions, and materials. The citation and discussion of references in this application is solely for the purposes of this invention. The references are provided solely for clarity of explanation and are not intended to be limiting unless otherwise specified. No admission of prior art is made. All references cited and discussed herein are hereby expressly incorporated by reference. The disclosures are incorporated herein by reference in their entirety. Although the present invention has been described and illustrated, changes and modifications may be made without departing from the spirit and scope of the invention. It will be apparent to those skilled in the art that the matter set forth in the above description and accompanying drawings is by way of example only. It is offered as an exclusive offer, not as a limitation.

Claims

1. a distal tube section having a longitudinal axis and a tube wall including at least one side port; and a guide tip engaged with the distal end of the distal tube section; A catheter device comprising: the guide tip defines a unitary body having an outer wall; and a plurality of fixation wings integrally formed with and fixed to the unitary body; Each wing extends radially outward from a portion of the outer wall; each wing defining an edge that is flush with the distal-most end of the guide tip; the catheter device includes at least one spiral cut, the at least one side port including a rim located within the spiral cut and undamaged by the spiral cut; each of the plurality of fixation wings is formed of a metal or a composite material; The catheter device.

2. The catheter device of claim 1 , wherein each of the plurality of fixation wings has an axial length that is less than the overall axial length of the guide tip.

3. The catheter device of claim 1 , wherein the plurality of fixation wings comprises four or more equally spaced wings.

4. The catheter device of claim 1 , wherein the at least one side port is radially offset from each of the plurality of fixation wings.

5. The catheter device of claim 1 , wherein the height of each of the plurality of fixation wings is in the range of 5% to 50% of the outer diameter of the guide tip.

6. a distal tube section having a longitudinal axis and a tube wall including at least one side port; and a guide tip engaged with the distal end of the distal tube section; A catheter device comprising: the guide tip defines a unitary body having an outer wall; and a plurality of fixation wings integrally formed with and fixed to the unitary body; Each wing extends radially outward from a portion of the outer wall; each wing defining an edge that is flush with the distal-most end of the guide tip; the catheter device further comprising a radiopaque marker affixed to the distal tube section in axial alignment with the at least one side port; each of the plurality of fixation wings is formed of a metal or a composite material; The catheter device.

7. The catheter device of claim 6 , wherein each of the plurality of fixation wings has an axial length that is less than the overall axial length of the guide tip.

8. The catheter device of claim 6 , wherein the plurality of fixation wings includes four or more equally spaced wings.

9. The catheter device of claim 6 , wherein the at least one side port is radially offset from each of the plurality of fixation wings.

10. The catheter device of claim 6, wherein the height of each of the plurality of fixation wings is in the range of 5% to 50% of the outer diameter of the guide tip.

11. a distal tube section having a longitudinal axis and a tube wall including at least one side port; and a guide tip engaged with the distal end of the distal tube section; A catheter device comprising: the guide tip defines a unitary body having an outer wall; and a plurality of fixation wings integrally formed with and fixed to the unitary body; Each wing extends radially outward from a portion of the outer wall; each wing defining an edge that is flush with the distal-most end of the guide tip; the catheter device further comprising a radiopaque marker surrounding the at least one side port; each of the plurality of fixation wings is formed of a metal or a composite material; The catheter device.

12. The catheter device of claim 11 , wherein each of the plurality of fixation wings has an axial length that is less than the overall axial length of the guide tip.

13. The catheter device of claim 11 , wherein the plurality of fixation wings comprises four or more equally spaced wings.

14. The catheter device of claim 11 , wherein the at least one side port is radially offset from each of the plurality of fixation wings.

15. The catheter device of claim 11, wherein the height of each of the plurality of fixation wings is in the range of 5% to 50% of the outer diameter of the guide tip.

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