Bendable guidewire lumen

Abstract

One aspect of some embodiments of the present application relates to a redirecting microcatheter comprising: an outer tubular body comprising a first proximal end and a first distal end; at least one inner tubular body sized and shaped to be inserted within the outer tubular body; the inner tubular body comprising a second proximal end and a second distal end; a dome-shaped tip connected to and extending distally from the first distal end of the outer tubular body; the dome-shaped tip comprising a plurality of openings; at least one actuator for translating the second distal end of the inner tubular body from a non-actuated position, at which the second distal end of the inner tubular body faces the first distal end, to at least one actuated position, at which the second distal end of the inner tubular body faces at least one of the plurality of openings of the dome-shaped tip.

Description

[0001] Related applications This application claims priority to U.S. Provisional Patent Application No. 63 / 622,596, filed January 19, 2024, the entire contents of which are incorporated herein by reference. Technical Field

[0002] In some embodiments of the present invention, the invention relates to catheters having a dedicated guidewire lumen, and more specifically, but not exclusively, to catheters having a flexible internal lumen. Background Technology

[0003] Other background technologies include U.S. Patent No. US6,217,527B1, which discloses a method and apparatus for completely traversing a substantially occluded vessel by passing a deflectable wire (such as a guidewire) from a relatively proximal point through an occlusion within the subintimal space formed between the intima and adventitia of the vessel wall. The wire can be advanced to a point distal to the occlusion and then typically deflected back into the vessel lumen using a deflection catheter, which is advanced along the guidewire after positioning it in the subintimal space. The deflection catheter may include a baffle valve assembly or a pre-shaped actuator wire for deflecting the guidewire. After the guidewire returns to the vessel lumen, the deflection catheter can be withdrawn, and the guidewire can be used to introduce other interventional and diagnostic catheters for procedures such as stenting.

[0004] US Patent Application Publication No. US2020282187A1 discloses a plug including a hollow distal portion comprising a distal end and a side hole located proximal to the distal end for receiving a guidewire and guiding the guidewire laterally from the plug.

[0005] US Patent No. 9233224B1 discloses a medical device and method for accessing collateral arteries. The device includes a catheter having sidewalls, an internal lumen, and a side port formed through the sidewalls. A perforated guidewire has a proximal portion within the internal lumen and a distal portion arranged to be removable from the side port. When the catheter is deployed to a position where the side port is aligned with the collateral artery, the guidewire can be delivered to the collateral artery through the side port. In another embodiment, the catheter has internal and external telescopic tubes, in which an offset outlet port is formed. The telescopic tubes can be used to change the degree of deflection of the perforated guidewire by changing the relative position of the offset outlet port.

[0006] U.S. Patent Application Publication No. US20020055733A1 discloses a catheter assembly and method for delivering guidewires into blood vessels. The catheter assembly of the present invention features two guidewire lumens within a single catheter to prevent wire tangling and crossing. A torsion member is provided to assist in catheter rotation. This assembly allows for the delivery of guidewires into collateral vessels at a steep angle relative to the main vessel. The assembly also provides the capability to deliver two guidewires to a bifurcation point.

[0007] U.S. Patent Application Publication No. US20010236774A1 discloses a catheter that allows selective guidance of surgical instruments into multiple blood vessels in a patient. The catheter includes a catheter body having a main outlet port and side outlet ports. An internal balloon is disposed within the catheter body. The internal balloon is inflatable and can be located at or near the distal portion of the side outlet ports. Upon deflation, the internal balloon allows the surgical instrument to advance through the side outlet ports and exit the main outlet port. Upon inflation, the internal balloon guides the surgical instrument forward and out of the side outlet ports instead of the main outlet port.

[0008] U.S. Patent Application Publication No. US20190091438A1 discloses a catheter having a lumen and including one or more side ports (or side ports) through an elongated body passing through the catheter at a predetermined location. The side ports (or side ports) (or side ports) (or side ports) can be positioned at an anatomical location of interest, and fluid (e.g., a drug) is injected along the catheter lumen and flows out from the side ports (or side ports) (or side ports) (to treat the anatomical location). Alternative embodiments may include a translational inner sheath that may cover some of the side ports (or side ports) (or side ports) and may also include orifices that can be aligned with at least one side port (or side ports) (or side ports). The side ports (or side ports) can be opened and closed by actuators such as push / pull wires or electrically responsive shape memory materials. Selective filters may be used to cover the side ports, allowing only fluids of specific viscosities and / or molecular sizes to pass through the filter and the side ports.

[0009] US Patent 9610438B2 discloses a delivery catheter including a catheter body, a side port, a first electrode, and a second electrode. The catheter body may include a proximal end, a distal end, and a circumferential surface. The catheter body defines a delivery lumen extending longitudinally within the catheter body. The side port is defined in a circumferential surface of the catheter body near the distal end and in communication with the delivery lumen. The electrode may be adjacent to and spaced apart from the side port. Techniques for using the delivery catheter to identify desired lead implantation sites (e.g., via the electrode) and for implanting a medical lead or other implantable element at the desired site via the delivery lumen and the side port are also described. Summary of the Invention

[0010] The following is a non-exclusive list of some examples including embodiments of the present invention. The invention also includes embodiments that include fewer than all features in one instance and embodiments that use features from multiple instances, even if not explicitly listed below.

[0011] Example 1. A redirecting microcatheter, comprising: a. An external tubular body, comprising a first proximal end and a first distal end; b. At least one internal tubular body, the size and shape of which are adapted for insertion into the external tubular body; the internal tubular body includes a second proximal end and a second distal end; c. A dome head, which is connected to and extends distally therefrom the first distal end of the outer tubular body; the dome head includes a plurality of openings; d. At least one actuator for translating the second distal end of the inner tubular body from a non-actuated position to at least one actuated position, wherein in the non-actuated position the second distal end of the inner tubular body faces the first distal end, and in the actuated position the second distal end of the inner tubular body faces at least one of the plurality of openings of the dome head.

[0012] Example 2. The redirection conduit according to Example 1, wherein the dome head includes a distal region and a proximal region, the distal region including a small opening and the proximal region including a large opening.

[0013] Example 3. The redirection catheter according to Example 1 or Example 2, wherein the dome head is non-invasive.

[0014] Example 4. A diversion duct according to any one of Examples 1-3, wherein the dome head is made of a plurality of metal wires.

[0015] Example 5. A redirecting conduit according to any one of Examples 1-4, wherein the actuator includes at least one retainer coupled to a location adjacent to the second distal end of the inner tubular body, and the at least one actuator is coupled to the at least one retainer.

[0016] Example 6. A redirecting conduit according to any one of Examples 1-5, wherein the translation includes bending the second distal end of the inner tubular body by an angle of about 1 degree to about 150 degrees.

[0017] Example 7. A redirecting conduit according to any one of Examples 1-6, wherein the translation includes bending the second distal end of the inner tubular body at an angle of approximately 90 degrees.

[0018] Example 8. A redirecting conduit according to any one of Examples 1-7, wherein the outer tubular body is made of one or more of nylon, Pebax, polyurethane, metal, PTFE, and any combination thereof.

[0019] Example 9. A redirecting conduit according to any one of Examples 1-8, wherein the outer tubular body is a braided / spring-wound shaft.

[0020] Example 10. A diversion conduit according to any one of Examples 1-9, wherein the length of the outer tubular body is from about 90 cm to about 180 cm.

[0021] Example 11. A redirection catheter according to any one of Examples 1-10, wherein the external tubular body is sized to pass through a 5F or 6F sheath.

[0022] Example 12. The diversion conduit according to any one of Examples 1-11, wherein the inner tubular body is made of a flexible material.

[0023] Example 13. The redirecting conduit according to any one of Examples 1-12, wherein at least a portion of the internal tubular body is made of a flexible material.

[0024] Example 14. The redirecting conduit according to any one of Examples 1-13, wherein at least the distal portion of the internal tubular body is made of a flexible material.

[0025] Example 15. A redirecting conduit according to any one of Examples 1-14, wherein the stiffness of the flexible portion of the inner tubular body is about 20 D Shore to about 60 D Shore.

[0026] Example 16. The diversion conduit according to any one of Examples 1-15, wherein the inner tubular body is made of one or more of nylon, Pebax, polyurethane, metal, PTFE, and any combination thereof.

[0027] Example 17. A diversion conduit according to any one of Examples 1-16, wherein the length of the internal tubular body is from about 100 mm to about 1800 mm.

[0028] Example 18. A redirecting conduit according to any one of Examples 1-17, wherein the length of the inner tubular body is approximately the length of the outer tubular body.

[0029] Example 19. A redirection catheter according to any one of Examples 1-18, wherein the inner tubular body is configured to be extracted from the outer tubular body, thereby allowing the insertion of other instruments into the outer tubular body.

[0030] Example 20. A redirection catheter according to any one of Examples 1-19, wherein the inner tubular body is configured to allow other instruments to be inserted into itself without needing to be withdrawn from the outer tubular body.

[0031] Example 21. A diversion conduit according to any one of Examples 1-20, wherein the at least one actuator is made of one or more of stainless steel, nickel-titanium alloy, cobalt-chromium alloy, nylon, PEEK and Dynema.

[0032] Example 22. The redirecting conduit according to any one of Examples 1-21, wherein the at least one retainer is a ring.

[0033] Example 23. A redirecting conduit according to any one of Examples 1-22, wherein at least one retainer is positioned on a flexible portion of the inner tubular body.

[0034] Example 24. A redirecting conduit according to any one of Examples 1-23, wherein the at least one retainer is positioned at a distance of about 1 mm to about 20 mm from the second distal end.

[0035] Example 25. A redirecting conduit according to any one of Examples 1-24, wherein the at least one retainer is arranged around the inner tubular body.

[0036] Example 26. A redirecting conduit according to any one of Examples 1-25, wherein the at least one retainer is a groove on the surface of the inner tubular body.

[0037] Example 27. A redirecting conduit according to any one of Examples 1-26, wherein the at least one retainer is made of one or more of stainless steel, nitinol, cobalt-chromium alloy, nylon, PEEK, platinum-iridium alloy and gold.

[0038] Example 28. A redirection catheter according to any one of Examples 1-27, wherein the size and shape of the internal tubular body allow for the insertion of at least one guidewire.

[0039] Example 29. A redirection conduit according to any one of Examples 1-28, wherein the external tubular body includes a first internal lumen, and the at least one actuator extends in the first internal lumen.

[0040] Example 30. A redirecting conduit according to any one of Examples 1-29, wherein the internal tubular body includes at least one second internal lumen, and the at least one actuator extends in the second internal lumen.

[0041] Example 31. A redirection catheter according to any one of Examples 1-30, wherein the internal tubular body includes a third internal lumen, and at least one guidewire is inserted into the third internal lumen.

[0042] Example 32. The redirection conduit according to any one of Examples 1-31 further includes at least one handle located proximal to the redirection conduit, the handle being configured to receive one or more of the first proximal end of the outer tubular body, the second proximal end of the inner tubular body, and the third proximal end of the actuator.

[0043] Example 33. The redirection duct according to any one of Examples 1-32 further includes a stabilizer configured to prevent bending of the first distal end when the at least one actuator is actuated.

[0044] Example 34. A redirection conduit according to any one of Examples 1-33, wherein the stabilizer extends from the first proximal end to the first distal end.

[0045] Example 35. A redirecting conduit according to any one of Examples 1-34, wherein the stabilizer extends within the lumen of the outer tubular body.

[0046] Example 36. A redirecting conduit according to any one of Examples 1-35, wherein the stabilizer extends between the outer tubular body and the inner tubular body.

[0047] Example 37. A redirecting conduit according to any one of Examples 1-36, wherein the stabilizer is within the lumen of the outer tubular body but extends outside the inner tubular body.

[0048] Example 38. A redirection conduit according to any one of Examples 1-37, wherein the stabilizer is configured to extend beyond the distal opening when actuated.

[0049] Example 39. A method for actuating a redirecting microcatheter according to Example 1 when using a guidewire, the method comprising: a. Retract the guidewire from the distal opening of the redirecting catheter; b. Actuate the internal tubular body to translate the second distal end of the internal tubular body from a non-actuated position to an actuated position, in which the second distal end of the internal tubular body faces the distal opening, and in the actuated position, the second distal end of the internal tubular body faces at least one of the plurality of openings of the dome head. c. Move the guidewire distally to exit the guidewire from at least one opening in the redirecting microcatheter.

[0050] Example 40. The method according to Example 39 further includes inserting the redirecting microcatheter into the patient.

[0051] Example 41. The method according to Example 39 or Example 40 further includes using the guidewire to guide the redirecting microcatheter toward a desired location to assist the guidance.

[0052] Example 42. The method according to any one of Examples 39-41, wherein the insertion further comprises inserting the guidewire into the redirecting microcatheter.

[0053] Example 43. The method according to any one of Examples 39-42, wherein the redirecting microcatheter has included the guidewire inserted therein.

[0054] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. While similar or equivalent methods and materials to those described herein may be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification (including definitions) shall prevail. Furthermore, materials, methods, and examples are illustrative only and are not necessarily limiting. Attached Figure Description

[0055] This document describes some embodiments of the invention by way of example only, with reference to the accompanying drawings. Referring now to the drawings in detail, it should be emphasized that the details shown are merely illustrative and for the purpose of illustrating embodiments of the invention. In this regard, the description taken in conjunction with the drawings will make it clear to those skilled in the art how to practice embodiments of the invention.

[0056] In the attached diagram: Figures 1a-1b This is a schematic diagram of an exemplary redirecting microcatheter according to some embodiments of the present invention; Figure 1c -d is a schematic diagram of an exemplary redirecting microcatheter including a dome head according to some embodiments of the present invention; Figure 1e -j is a detailed schematic diagram of an exemplary redirecting microcatheter including a dome head according to some embodiments of the present invention; Figure 1k-1m This is a schematic diagram of an exemplary redirecting microcatheter including a reinforced region according to some embodiments of the present invention; Figures 2a-2b This is a schematic diagram of an exemplary redirecting microcatheter with a guidewire according to some embodiments of the present invention; Figures 3a-3b This is an exemplary multi-lumen redirection catheter according to some embodiments of the present invention; Figures 4a-4b This is an exemplary multi-lumen redirection catheter according to some embodiments of the present invention; Figure 5 This is a flowchart of an exemplary method according to some embodiments of the present invention; Figures 6a-6b This is a schematic diagram of an exemplary optional stabilizer according to some embodiments of the present invention; Figure 7 This is a flowchart of an exemplary method for using an exemplary stabilizer according to some embodiments of the present invention. Detailed Implementation

[0057] In some embodiments of the present invention, the invention relates to catheters having a dedicated guidewire lumen, and more specifically, but not exclusively, to catheters having a flexible internal lumen.

[0058] Overview One aspect of some embodiments of the present invention relates to a redirection catheter configured to allow one or more instruments to exit the catheter from one or more lateral openings in a dome located at the distal end of the redirection catheter. In some embodiments, the dome includes a mesh structure or any other similar construction. In some embodiments, the dome includes a plurality of openings. In some embodiments, the openings all have the same size. In some embodiments, the openings have different sizes. In some embodiments, the dome includes a distal region and a proximal region, the distal region including a small opening and the proximal region including a large opening. In some embodiments, the dome has two or more lateral openings, and the user can select which lateral opening to use. In some embodiments, the redirection catheter includes one or more inner tubes located within the redirection catheter, the one or more inner tubes being configured to be guided toward one or more lateral openings without changing the orientation of the redirection catheter. In some embodiments, when two inner tubes are located within the redirection catheter, one is actuated while the other remains stationary. In some embodiments, when two inner tubes are located within the redirection catheter, both tubes are configured to be optionally actuated simultaneously. In some embodiments, one or more lateral openings are large enough to allow passage of one or more of a guidewire, balloon catheter, stent catheter, interventional device, and drug delivery device. In some embodiments, one or more inner tubes can be guided at an angle of about 1 degree to about 150 degrees, preferably about 90 degrees, relative to the longitudinal axis of the redirecting catheter. In some embodiments, the redirecting catheter is reinforced, optionally proximal to the dome, at the area where one or more inner tubes are redirected. In some embodiments, reinforcement is achieved by adding a metal insert to the outer tube. In some embodiments, reinforcement is added over the entire area including the lateral opening. In some embodiments, reinforcement is added at selected locations near or adjacent to the lateral opening, optionally proximal to the dome. In some embodiments, reinforcement prevents undesirable bending of the outer tube at the location of the lateral opening. In some embodiments, the redirecting catheter includes a stabilizer. In some embodiments, the stabilizer is configured to prevent undesirable bending of the distal end of the outer tube when the inner tube is bent to allow the guidewire to be redirected through the lateral opening. In some embodiments, the stabilizer is a filament extending from the proximal end to the distal end of the outer tube within the lumen of the outer tube. In some embodiments, the stabilizer is a filament extending from the proximal end to the distal end of the outer tube within the lumen of the inner tube. In some embodiments, the filament is an internally integrated filament or an additional guide wire. In some embodiments, the stabilizer is configured to move forward and backward. In some embodiments, forward movement of the stabilizer allows the distal end of the stabilizer to exit through a distal opening in the outer tube and / or a distal opening in the dome head. In some embodiments, the stabilizer is rigid enough to prevent the distal end of the outer tube and / or the dome head from bending when one or more inner tubes are bent.

[0059] Before explaining at least one embodiment of the present invention in detail, it should be understood that the invention is not necessarily limited to the details of the construction and / or arrangement of the components and / or methods illustrated and / or depicted in the following description and / or drawings and / or embodiments. The invention can have other embodiments, or can be practiced or performed in various ways.

[0060] Now for reference Figures 1a-1b This diagram illustrates an exemplary redirecting microcatheter 100 according to some embodiments of the present invention. In some embodiments, the redirecting microcatheter 100 includes an outer tubular body 102, which includes a proximal end 104 and a distal end 106. In some embodiments, the proximal end is connected to an actuation handle (not shown). In some embodiments, the outer tubular body 102 includes a distal opening 108 located at the distal end 106 of the outer tubular body 102, and at least one lateral opening 110 (hereinafter referred to as "lateral opening 110," although mentioned separately, it should be understood that the scope of the invention also includes more than one lateral opening) located near and proximally to the distal end 106 of the outer tubular body 102. In some embodiments, the outer tubular body 102 includes one lateral opening 110. In some embodiments, the outer tubular body 102 includes two lateral openings 110. In some embodiments, the outer tubular body 102 includes three or more lateral openings 110. In some embodiments, optionally, the distal opening 108 and / or one or more lateral openings 110 are large enough to allow passage of one or more of a guidewire (0.035 mm guidewire, 0.018 mm guidewire, or 0.014 mm guidewire), an internal tubular body (see below), a balloon catheter, a stent catheter, and a microcatheter.

[0061] In some implementations, the size (or diameter) of the distal opening 108 is about 0.015 inches to about 0.1 inches. For example, 0.015 inches, 0.02 inches, 0.036 inches, 0.04 inches, 0.055 inches, 0.084 inches, 0.09 inches.

[0062] In some implementations, the size (or diameter) of the lateral opening 110 is about 0.015 inches to about 0.1 inches. For example, 0.015 inches, 0.02 inches, 0.036 inches, 0.04 inches, 0.055 inches, 0.084 inches, 0.09 inches.

[0063] In some embodiments, the lateral opening 110 is located at a distance of about 0.5 mm to about 10 mm from the distal opening 108. Optionally, it is about 0.3 mm to about 20 mm. Optionally, it is about 0.1 mm to about 50 mm.

[0064] In some embodiments, the outer tubular body 102 is made of one or more of nylon, Pebax, polyurethane, metal, PTFE, and any combination thereof. In some embodiments, the outer tubular body is a braided / spring-wound shaft.

[0065] In some embodiments, the length of the outer tubular body 102 is from about 90 cm to about 180 cm. Optionally, it is from about 80 cm to about 200 cm. Optionally, it is from about 50 cm to about 250 cm. In some embodiments, the outer tubular body 102 is sized to pass through a 5F or 6F sheath.

[0066] In some embodiments, the redirecting microcatheter 100 includes an internal tubular body 112, which includes a proximal end 114 and a distal end 116. In some embodiments, the proximal end 114 of the internal tubular body 112 is connected to an actuation handle (not shown). In some embodiments, the distal end 116 of the internal tubular body 112 extends distally to one or more lateral openings 110 (…). Figure 1a -b shows the location of a lateral opening (but more than one lateral opening is also included within the scope of this invention). In some embodiments, the inner tubular body 112 is made of a flexible material. In some embodiments, at least a portion of the inner tubular body 112 is made of a flexible material. In some embodiments, at least the distal portion of the inner tubular body 112 is made of a flexible material.

[0067] In some embodiments, the hardness of the flexible portion of the internal tubular body 112 is about 20A Shore hardness to about 60A Shore hardness; optionally, about 10A Shore hardness to about 75A Shore hardness; optionally, about 0A Shore hardness to about 100A Shore hardness; for example, 70A Shore hardness, 50A Shore hardness, and 25A Shore hardness. In some embodiments, the hardness of the flexible portion of the internal tubular body 112 is about 20D Shore hardness to about 60D Shore hardness; optionally, about 10D Shore hardness to about 75D Shore hardness; optionally, about 0D Shore hardness to about 100D Shore hardness; for example, 55D Shore hardness, 40D Shore hardness, and 25D Shore hardness.

[0068] In some embodiments, the inner tubular body 112 is made of one or more of nylon, Pebax, polyurethane, metal, PTFE, and any combination thereof. In some embodiments, the outer tubular body is a braided / spring-wound shaft.

[0069] In some embodiments, the length of the inner tubular body 112 is from about 100 mm to about 1800 mm. Optionally, it is from about 50 mm to about 2000 mm. Optionally, it is from about 25 mm to about 2500 mm. In some embodiments, the length of the inner tubular body 112 is about the length of the outer tubular body 102.

[0070] In some embodiments, the distal end 116 of the inner tubular body 112 extends from the proximal end of the device to a distance of about 0.1 cm to about 1.5 cm from the distal end 106 of the outer tubular body 102.

[0071] In some embodiments, the internal tubular body 112 is configured to be withdrawn from the redirecting microcatheter 100 to allow insertion of other instruments into the redirecting microcatheter 200. In some embodiments, the internal tubular body 112 is configured to allow insertion of other instruments into itself without the need to withdraw the internal tubular body 112.

[0072] In some embodiments, the redirecting microcatheter 100 includes one or more actuators 118 (two are shown). In some embodiments, the actuator 118 is a filament. In some embodiments, the actuator 118 is a push-pull filament. In some embodiments, the actuator 118 is made of one or more of stainless steel, nitinol, cobalt-chromium alloy, nylon, PEEK, and Dyneema.

[0073] In some embodiments, actuator 118 includes a proximal end 120 and a distal end 122. In some embodiments, the proximal end 120 of actuator 118 extends into the interior of an actuation handle (not shown) to reach an actuation mechanism, which will be explained further below. In some embodiments, the distal end 122 of actuator 118 is connected to a retainer 124 (see below) located near the distal end 116 of the inner tubular body 112. In some embodiments, pulling one actuator will cause the inner tubular body 112 to bend in one direction, while pulling the other actuator will cause the inner tubular body 112 to bend in another direction.

[0074] In some embodiments, the redirecting microcatheter 100 includes a retainer 124. In some embodiments, the retainer 124 is connected to the inner tubular body 112 at a location adjacent to the distal end 116 of the inner tubular body 112. In some embodiments, the retainer 124 is connected to at least a portion of the flexible portion of the inner tubular body 112. In some embodiments, the retainer 124 is located from about 1 mm to about 20 mm from the distal end 116 of the inner tubular body 112. Optionally, it is from about 0.5 mm to about 40 mm. Optionally, it is from about 0.1 mm to about 60 mm.

[0075] In some embodiments, the retainer 124 is a ring or a band. In some embodiments, the retainer 124 is arranged around the inner tubular body 112. In some embodiments, the retainer 124 is a groove on the surface of the inner tubular body 112, and the distal end 122 of the actuator is located within the groove.

[0076] In some embodiments, the retainer 124 is made of one or more of stainless steel, nitinol, cobalt-chromium alloy, nylon, PEEK, platinum-iridium alloy, and gold.

[0077] In some embodiments, as described above, actuation of actuator 118 causes a portion of the distal end 116 of the internal tubular body 112 to translate from a first position to a second position. In some embodiments, the first position is a rest position in which a portion of the distal end 116 of the internal tubular body 112 is not actuated, and the distal end 116 of the internal tubular body 112 is aligned with the longitudinal axis 126 of the redirecting microcatheter 100, for example, as... Figure 1a As shown. In some embodiments, the second position is an actuated position in which a portion of the distal end 116 of the inner tubular body 112 is actuated and translated from the longitudinal axis 126 to face and / or be guided (see arrow 128) toward one of the lateral openings 110 (as previously described). Figure 1a -b only displays one), for example, such as Figure 1b As shown. The exemplary use of the push-pull wire will serve as an exemplary actuator for the following explanation. It should be understood that this is done to allow those skilled in the art to understand the invention and should not be used to limit the invention in any way. In some embodiments, the push-pull wire actuates the inner tubular body 112 from a first position to a second position (or from an unactuated position to an actuated position). In some embodiments, the push-pull wire actuates the inner tubular body 112 from a second position to a first position (or from an actuated position to an unactuated position). In some embodiments, the natural state of the inner tubular body 112 is in a rest position (unactuated position), and during actuation, the inner tubular body 112 will "want" to return to the rest position. Therefore, in some embodiments, actuation of the inner tubular body 112 includes actively translating a portion of the distal end 116 of the inner tubular body 112 from the rest position to the actuated position by pulling the push-pull wire and keeping the push-pull wire taut until actuation is no longer needed. Then, in some embodiments, releasing and / or reducing the tension of the push-pull wire allows the inner tubular body 112 to return to its natural rest position.

[0078] In some embodiments, the translation during actuation is about 1 degree to about 90 degrees relative to the longitudinal axis 126 of the redirecting microcatheter 100. Optionally, it is about 1 degree to about 150 degrees. Optionally, it is about 1 degree to about 170 degrees.

[0079] Now for reference Figures 1c-1dThis image shows a schematic diagram of an exemplary redirecting microcatheter 150 including a dome head according to some embodiments of the present invention. In some embodiments, the redirecting microcatheter 150 includes an outer tubular body 102 including a proximal end 104 and a distal end 106. In some embodiments, the proximal end is connected to an actuation handle (not shown). In some embodiments, a dome head 152 is located at the distal end of the outer tubular body 102. In some embodiments, the dome head includes a mesh structure or any other similar structure. In some embodiments, a potential advantage of having a dome head 152 is that it allows for easy redirection of an inner tubular body 112. In some embodiments, the dome head 152 is non-invasive. In some embodiments, the dome head 152 is a dome head made of one or more of metal wires, non-metal wires, and / or transmissive filaments. In some embodiments, the dome head is made of a single-piece molded part having openings therein. In some embodiments, the dome head includes a plurality of openings 154. In some embodiments, the plurality of openings 154 are configured to allow one or more guidewires (0.035 mm, 0.018 mm, or 0.014 mm guidewires), an internal tubular body (see below), a balloon catheter, a stent catheter, and a microcatheter to pass forward or from the side of the dome head. In some embodiments, the plurality of openings 154 have the same size. In some embodiments, the plurality of openings 154 have different sizes. In some embodiments, the openings 154 located on the side (here the internal tubular body 112 is configured as an outlet) are larger than the opening located at the most distal end of the dome head 150. In some embodiments, the dome head includes a distal region and a proximal region, the distal region including a small opening and the proximal region including a large opening. In some embodiments, exemplary dimensions of the openings 154 are from about 0.5 × 0.5 mm to about 1 × 4 mm, optionally from about 0.4 × 0.4 mm to about 3 × 8 mm, optionally from about 0.1 × 0.1 mm to about 5 × 10 mm.

[0080] In some embodiments, the length of the dome head is from about 1 mm to about 5 mm, optionally from about 3 mm to about 7 mm, and optionally from about 4 mm to about 10 mm. In some embodiments, the dome head extends beyond the farthest end of the outer tubular body 102.

[0081] In some embodiments, the outer tubular body 102 is made of one or more of nylon, Pebax, polyurethane, metal, PTFE, and any combination thereof. In some embodiments, the outer tubular body is a braided / spring-wound shaft.

[0082] In some embodiments, the length of the outer tubular body 102 is from about 90 cm to about 180 cm. Optionally, it is from about 80 cm to about 200 cm. Optionally, it is from about 50 cm to about 250 cm. In some embodiments, the outer tubular body 102 is sized to pass through a 5F or 6F sheath.

[0083] In some embodiments, the redirecting microcatheter 150 includes one or more internal tubular bodies 112 ( Figure 1c -d indicates one), which includes a proximal end 114 and a distal end 116. In the following paragraphs, embodiments having one internal tubular body 112 will be explained; it should be understood that more than one internal tubular body is also included within the scope of the invention. In some embodiments, the proximal end 114 of the internal tubular body 112 is connected to an actuating handle (not shown). In some embodiments, the distal end 116 of the internal tubular body 112 extends distally to near the location of the opening 154 on the dome head 152. In some embodiments, the internal tubular body 112 is made of a flexible material. In some embodiments, at least a portion of the internal tubular body 112 is made of a flexible material. In some embodiments, at least the distal portion of the internal tubular body 112 is made of a flexible material.

[0084] In some embodiments, the hardness of the flexible portion of the internal tubular body 112 is about 20A Shore hardness to about 60A Shore hardness; optionally, about 10A Shore hardness to about 75A Shore hardness; optionally, about 0A Shore hardness to about 100A Shore hardness; for example, 70A Shore hardness, 50A Shore hardness, and 25A Shore hardness. In some embodiments, the hardness of the flexible portion of the internal tubular body 112 is about 20D Shore hardness to about 60D Shore hardness; optionally, about 10D Shore hardness to about 75D Shore hardness; optionally, about 0D Shore hardness to about 100D Shore hardness; for example, 55D Shore hardness, 40D Shore hardness, and 25D Shore hardness.

[0085] In some embodiments, the inner tubular body 112 is made of one or more of nylon, Pebax, polyurethane, metal, PTFE, and any combination thereof. In some embodiments, the outer tubular body is a braided / spring-wound shaft.

[0086] In some embodiments, the length of the inner tubular body 112 is from about 100 mm to about 1800 mm. Optionally, it is from about 50 mm to about 2000 mm. Optionally, it is from about 25 mm to about 2500 mm. In some embodiments, the length of the inner tubular body 112 is about the length of the outer tubular body 102.

[0087] In some embodiments, the distal end 116 of the inner tubular body 112 extends from the proximal end of the device to a distance of about 0.1 cm to about 1.5 cm beyond the distal end 106 of the outer tubular body 102 and into the region of the dome head 152.

[0088] In some embodiments, the internal tubular body 112 is configured to be withdrawn from the redirecting microcatheter 150 to allow insertion of other instruments into the redirecting microcatheter 150. In some embodiments, the internal tubular body 112 is configured to allow insertion of other instruments into itself without the need to withdraw the internal tubular body 112.

[0089] In some embodiments, the redirecting microcatheter 150 includes one or more actuators 118. In some embodiments, the one or more actuators 118 are filaments. In some embodiments, the one or more actuators 118 are push-pull filaments. In some embodiments, the one or more actuators 118 are made of one or more of stainless steel, nitinol, cobalt-chromium alloy, nylon, PEEK, and Dyneema.

[0090] In some embodiments, one or more actuators 118 include a proximal end 120 and a distal end 122. In some embodiments, the proximal end 120 of one or more actuators 118 extends into the interior of an actuation handle (not shown) to reach an actuation mechanism, which will be explained further below. In some embodiments, the distal end 122 of the actuator 118 is connected to a retainer 124 located near the distal end 116 of the internal tubular body 112 (see below).

[0091] In some embodiments, the redirecting microcatheter 150 includes a retainer 124. In some embodiments, the retainer 124 is attached to the inner tubular body 112 at a location adjacent to the distal end 116 of the inner tubular body 112. In some embodiments, the retainer 124 is attached to at least a portion of the flexible portion of the inner tubular body 112. In some embodiments, the retainer 124 is located from about 1 mm to about 20 mm from the distal end 116 of the inner tubular body 112. Optionally, it is from about 0.5 mm to about 40 mm. Optionally, it is from about 0.1 mm to about 60 mm.

[0092] In some embodiments, the retainer 124 is a ring or a band. In some embodiments, the retainer 124 is arranged around the inner tubular body 112. In some embodiments, the retainer 124 is a groove on the surface of the inner tubular body 112, and the distal end 122 of the actuator is located within the groove.

[0093] In some embodiments, the retainer 124 is made of one or more of stainless steel, nitinol, cobalt-chromium alloy, nylon, PEEK, platinum-iridium alloy, and gold.

[0094] In some embodiments, actuation of actuator 118 causes a portion of the distal end 116 of the internal tubular body 112 to translate from a first position to a second position. In some embodiments, the first position is a rest position in which a portion of the distal end 116 of the internal tubular body 112 is not actuated, and the distal end 116 of the internal tubular body 112 is aligned with the longitudinal axis 126 of the redirecting microcatheter 150, for example, as Figure 1c As shown. In some embodiments, the second position is an actuated position in which a portion of the distal end 116 of the inner tubular body 112 is actuated and translated from the longitudinal axis 126 to face and / or be guided (see arrow 128) toward one of the lateral openings 154, for example, as Figure 1d As shown. In some embodiments, the direction of translation depends on the actuated actuator; for example, actuating the bottom actuator will result in translation in another direction. The exemplary use of the push-pull wire will serve as an exemplary actuator explained below. It should be understood that this is done to allow those skilled in the art to understand the invention and should not be construed as limiting the invention in any way. In some embodiments, the push-pull wire actuates the inner tubular body 112 from a first position to a second position (or from an unactuated position to an actuated position). In some embodiments, the push-pull wire actuates the inner tubular body 112 from a second position to a first position (or from an actuated position to an unactuated position). In some embodiments, the natural state of the inner tubular body 112 is in a rest position (unactuated position), and during actuation, the inner tubular body 112 will "want" to return to the rest position. Therefore, in some embodiments, actuation of the inner tubular body 112 includes actively translating a portion of the distal end 116 of the inner tubular body 112 from the rest position to the actuated position by pulling the push-pull wire and keeping the push-pull wire taut until actuation is no longer needed. Then, in some embodiments, releasing and / or reducing the tension of the push-pull wire allows the inner tubular body 112 to return to its natural rest position.

[0095] In some embodiments, the translation during actuation is about 1 degree to about 90 degrees relative to the longitudinal axis 126 of the redirecting microcatheter 150. Optionally, it is about 1 degree to about 150 degrees. Optionally, it is about 1 degree to about 170 degrees.

[0096] Now for reference Figure 1e -j shows a schematic diagram of an exemplary redirection duct 160 including a dome head according to some embodiments of the present invention. Figure 1e-h indicates exemplary dimensions, which are provided by way of example only and are not intended to limit the invention in any way. In some embodiments, similar to the above disclosure, the exemplary redirection conduit 160 includes an outer tubular body 102 including a proximal end 104 and a distal end 106. In some embodiments, the redirection conduit 160 includes at least one inner tubular body 112, the size and shape of which allow for the insertion of at least one guidewire. In some embodiments, a dome head 152 is attached to the distal end 106 of the outer tubular body 102, partially shown here to allow for the display of other parts of the device. In some embodiments, the dome head 152 includes a plurality of openings 154. In some embodiments, the dome head 152 includes a denser region 156 having more and smaller openings at the most distal portion of the dome head 152, while in other embodiments it includes a sparser region 158 having fewer and larger openings proximal to the dome head 152, particularly in the region where the inner tubular body 112 is configured to withdraw upon rerouting (actuation). In some embodiments, the exemplary rerouting conduit 160 includes one or more actuators 118, such as two push-pull wires 118, extending from the proximal end 104 of the outer tubular body 102 to a location near or adjacent to the distal end of the inner tubular body 112. In some embodiments, as described above, actuation of the push-pull wires 118 causes the distal end of the inner tubular body 112 to bend to either side, for example, as... Figure 1i and Figure 1j As illustrated schematically. In some embodiments, the exemplary redirection conduit includes a dedicated channel 162 for each actuator 118 (see also...). Figure 1g and 1h In some embodiments, the push-pull wire 118 is connected to the inner tubular body 112 via a retainer 124. In some embodiments, optionally, the redirecting conduit includes a coil flat wire (e.g. Figure 1g As shown), it extends partly or entirely along the inner tubular body 112 and is configured to provide support to the inner tubular body 12 and prevent the inner tubular body 112 from collapsing.

[0097] Now for reference Figure 1k-1l This image shows a schematic diagram of an exemplary redirecting microcatheter 100 including a reinforced region according to some embodiments of the present invention. In some embodiments, Figure 1k and 1lThe reinforcement region shown can also be applied to the exemplary redirection conduits 150 and 160. In some embodiments, the redirection microcatheter 100 includes a reinforcement region 130 in the region surrounding the lateral opening 110. In some embodiments, the reinforcement region includes one or more metal elements that impart a degree of stiffness to the reinforcement region that is higher than the stiffness of the region without metal elements. For example, the outer tubular body 102 may be made of a flexible material (e.g., PEBAX), and the reinforcement region may include a metal braid embedded within the outer tubular body 102 and extending over the region surrounding the lateral opening 110, such as... Figure 1m As shown. In some embodiments, the metal element includes any suitable form, for example, it can be a metal braid, metal support, metal rod, metal ring, etc. In some embodiments, the metal element is located on a portion of the outer tubular body 102, meaning that not all areas around the lateral opening 110 are reinforced. For example, the reinforced area may be opposite the lateral opening 110, at two locations near the lateral opening 110, etc. In some embodiments, the reinforced area 130 does not obstruct the lateral opening 110. In some embodiments, a potential advantage of having a reinforced area 130 around the lateral opening 110 is that it potentially avoids undesirable bending of the outer tubular body 102 due to the force applied when actuating the inner tubular body 112, thereby reorienting the device located within the inner tubular body. In some embodiments, the reinforced area 130 is also present. Figure 2a The implementations disclosed in -b, 3a-b and 4a-b.

[0098] Now for reference Figures 2a-2b This diagram illustrates an exemplary redirecting microcatheter 100 with a guidewire 202 according to some embodiments of the present invention. The same mechanism applies to exemplary redirecting catheters 150 and 160 including a dome head 152. In some embodiments, an inner tubular body 112 allows the guidewire 202 to be inserted therein, for example, the guidewire 202 is used to guide the redirecting microcatheter 100 toward a desired location. In some embodiments, the redirecting microcatheter 100 is configured to allow the guidewire 202 to be inserted and withdrawn within the inner tubular body 112. In some embodiments, the distal end of the guidewire 202 can be withdrawn from the inner tubular body 112 and distal end 106 of the redirecting microcatheter 100 using a distal opening 108, for example, as... Figure 2a As shown. In the following text, this will be referred to as “distal withdrawal” of the guidewire. In some embodiments, this is permitted when the internal tubular body 112 is in a resting position. In some embodiments, when actuated, the distal end of the guidewire 202 can be withdrawn from the internal tubular body 112 and the redirecting microcatheter 100 using the lateral opening 110, for example, as... Figure 2bAs shown. In the following text, this will be referred to as the “lateral withdrawal” of the guidewire. In some embodiments, the guidewire 202 is switched from distal withdrawal to lateral withdrawal, and vice versa, requiring the guidewire 202 to be inserted into the internal tubular body 112 before actuating the internal tubular body 112 from one configuration (actuated or non-actuated) to another configuration.

[0099] In some implementations, the guidewire 202 may be a 0.035 mm guidewire, a 0.018 mm guidewire, a 0.014 mm guidewire, or a 0.009 mm guidewire.

[0100] Exemplary multi-lumen redirecting microcatheter Now for reference Figure 3a -b illustrates an exemplary multi-lumen redirecting conduit 200 according to some embodiments of the present invention. In some embodiments, one or more of the components disclosed above are incorporated within a dedicated lumen, optionally a dedicated elongated member, such as a tube.

[0101] For example, in some embodiments, the actuator 118 is incorporated within a dedicated tube 302 that extends from the proximal end 104 of the outer tubular body 102 to a position adjacent to the retainer 124. In some embodiments, the dedicated tube 302 extends in a region within the outer tubular body 102 and outside the inner tubular body 112.

[0102] Another example is that, in some embodiments, the guidewire 202 is incorporated within a dedicated tube 304 that extends from the proximal end 104 of the inner tubular body 112 to a position adjacent to the distal end 116 of the inner tubular body 112. In some embodiments, the dedicated tube 304 extends within a region of the inner tubular body 112.

[0103] Now for reference Figure 4a -b shows another exemplary multi-lumen redirecting catheter 300 according to some embodiments of the present invention. In some embodiments, an actuator 118 is incorporated within a dedicated tube 402 extending from the proximal end 104 of the outer tubular body 102 to a position adjacent to the retainer 124. In some embodiments, the dedicated tube 402 extends within a region of the inner tubular body 112. Furthermore, in some embodiments, a guidewire 202 is incorporated within the dedicated tube 404 extending from the proximal end 104 of the inner tubular body 112 to a position adjacent to the distal end 116 of the inner tubular body 112. In some embodiments, the dedicated tube 404 extends within a region of the inner tubular body 112.

[0104] Exemplary handle In some embodiments, the device includes a handle at the proximal end. In some embodiments, the handle includes a dedicated mechanism for actuating one or more mechanisms of the catheter, as known in the art. In some embodiments, the handle includes an actuator to which a push-pull wire is connected. In some embodiments, the user actuates the actuator, pulling the push-pull wire to translate the internal tubular body toward one or more lateral openings. In some embodiments, the user actuates the actuator again to release and / or push the push-pull wire, translating the internal tubular body back to its initial position facing the distal opening of the device. In some embodiments, the actuator includes two modes: a free-actuating mode, in which the user freely actuates the actuator from one position to another; and a semi-locked actuating mode, in which actuation of the actuator is incremental, for example, the internal tubular body translates a certain amount, such as 10 degrees, each time the user actuates the actuator. In some embodiments, this means, for example, that the user needs to actuate the actuator nine times to move the internal tubular body to a 90-degree angle. In some implementations, in the semi-locked actuation mode, the actuator remains in the last actuated position after each actuation step. In some implementations, in the free actuation mode, the user maintains tension on the push-pull wire by holding the actuator, and releasing the actuator allows the internal tubular body to return to a stationary, unactuated position.

[0105] Exemplary methods Now for reference Figure 5This diagram illustrates a flowchart of an exemplary method according to some embodiments of the present invention. In some embodiments, the user inserts a redirection catheter into the patient's body 502. In some embodiments, the user inserts a guidewire into the redirection catheter 504. In some embodiments, the guidewire is already inside the redirection catheter when it is inserted into the patient's body. In some embodiments, the user guides the redirection catheter toward a desired location using known methods, optionally using the guidewire to assist in this guidance 506. In some embodiments, the guidewire is withdrawn from the redirection catheter at this point using a distal opening in the redirection catheter. In some embodiments, at some point during guidance, the user assesses whether the redirection catheter is needed 508. In some embodiments, if the answer is no, the user continues guiding the redirection catheter 510. In some embodiments, if the answer is yes, the user moves the guidewire proximally until the distal end of the guidewire reaches the internal tubular body 512. In some embodiments, once the distal end of the guidewire is within the internal tubular body, the user actuates the internal tubular body 514 to translate the distal end of the internal tubular body from a first position to a second position, wherein the first position is the position where the internal tubular body follows the longitudinal axis of the redirecting catheter, and the second position is the position where the distal end of the internal tubular body is redirected toward at least one lateral opening of the redirecting catheter. In some embodiments, the user then moves the guidewire distally to withdraw it from at least one lateral opening of the redirecting catheter 516. In some embodiments, once the guidewire is in place, the user can push the redirecting catheter into the correct position. In some embodiments, once in the correct position, the user retracts the guidewire, returning the internal tubular body to its rest position, and continues to guide the device to the desired position.

[0106] Example mark In some embodiments, the exemplary redirection conduit includes one or more markings that help a user identify the direction the lateral opening 110 faces. For example, a radiopaque marker is positioned near the lateral opening 110, which can be seen using known visualization techniques. Another example is that the lateral opening 110 is marked with, for example, a semicircle or a full circle surrounding the opening itself. In some embodiments, the radiopaque marker is added as a dot (e.g.) on the surface of the outer tubular body 102 and around the opening itself.

[0107] In some embodiments, the elements of the redirecting conduit may be made of or have an addition of a radiopaque material. For example, one or more of the actuator 118, retainer 124, and dedicated ring located at the distal end of the outer tubular body 102 of the redirecting mechanism may be made of or have an addition of a radiopaque material. In some embodiments, a potential advantage of marking the actuator 118 is that it will provide a “line” that directly indicates the direction of the opening.

[0108] In some implementations, additionally or alternatively, the redirection conduit includes a marking at the handle that indicates to the user the direction in which the lateral opening 110 is facing.

[0109] In some embodiments, additionally or alternatively, the redirection conduit includes an actuation element on the handle that, once actuated, performs a redirection action. In some embodiments, the position of the actuation element on the handle indicates to the user the direction the opening is facing, as it is located on the same side as the opening.

[0110] Example optional stabilizer Now for reference Figure 6a -b illustrates an exemplary optional stabilizer according to some embodiments of the invention. In some embodiments, the exemplary redirecting conduit 600 optionally includes a stabilizer 602. In some embodiments, the stabilizer 602 includes a filament extending from the proximal end 104 to the distal end 106 of the outer tubular body 102. In some embodiments, the stabilizer 602 is positioned between the outer tubular body 102 and the inner tubular body 112. In some embodiments, the stabilizer 602 includes its own dedicated tube (not shown) or extends only within the lumen of the outer tubular body 102, identical to the inner tubular body 112.

[0111] In some embodiments, stabilizer 602 includes a dedicated channel extending from the proximal end of the device to the distal end.

[0112] In some embodiments, the stabilizer 602 is a metal wire. In some embodiments, the diameter of the stabilizer 602 is from about 150 micrometers to about 0.5 mm. In some embodiments, the stabilizer 602 is strong enough to prevent the outer tube from bending when the redirecting actuator is actuated, but weak enough not to affect the flexibility of the outer tube, and thus the flexibility of the redirecting conduit.

[0113] In some embodiments, during operation of the redirection catheter 600, when the user wishes to use the distal opening 108 of the outer tubular body 102 as the exit of the guidewire 202—the distal end of the guidewire 202 is withdrawn, and the stabilizer 602 is held within the lumen of the outer tubular body 102—this is the inactive state of the stabilizing element, such as... Figure 6a As shown schematically.

[0114] In some embodiments, as described above, during operation of the redirection conduit 600, when the user wants to redirect the guidewire 202 to exit through the lateral opening 110—lateral exit—the user needs to bend the inner tubular body 112 toward the lateral opening 110 by actuating the actuator 118. In some embodiments, before or during actuation of the redirection mechanism, the user “activates” the stabilization mechanism by withdrawing the stabilizer 602 through the farthest lateral opening 108 of the outer tubular body 102 into the lumen of the outer tubular body 102—this is the active state of the stabilizing element, such as… Figure 6b As illustrated schematically. In some embodiments, the activation of stabilizer 602 is achieved by pushing stabilizer 602 forward in the distal direction of the diversion duct, while the deactivation of stabilizer 602 is achieved by pulling stabilizer 602 backward in the proximal direction of the diversion duct.

[0115] In some implementations, a potential advantage of having stabilizer 602 is that it can potentially prevent bending of the outer tubular body 102 during actuation of the reversing mechanism, which would mean bending of the inner tubular body 112 during reversing action.

[0116] Exemplary method with stabilizing element Now for reference Figure 7This diagram illustrates a flowchart of an exemplary method of using a stabilizer according to some embodiments of the present invention. In some embodiments, the user inserts a redirection catheter into the patient's body 702. In some embodiments, the user inserts a guidewire into the redirection catheter 704. In some embodiments, the guidewire is already inside the redirection catheter when it is inserted into the patient's body. In some embodiments, the user guides the redirection catheter toward a desired location 706 using known methods, optionally using the guidewire to assist in this guidance. In some embodiments, the guidewire is withdrawn from the redirection catheter at this point using a distal opening in the redirection catheter. In some embodiments, at some point during guidance, the user assesses whether the redirection catheter is needed 708. In some embodiments, if the answer is no, the user continues guiding the redirection catheter 710. In some embodiments, if the answer is yes, the user moves the guidewire proximally until the distal end of the guidewire reaches the inner tubular body 712. In some embodiments, once the distal end of the guidewire is inside the inner tubular body, the user actuates the stabilizer 714 by withdrawing the stabilizer through the distal end of the outer tubular body. In some embodiments, after activating the stabilizer, the user actuates the internal tubular body 716 to translate the distal end of the internal tubular body from a first position to a second position, wherein the first position is the position where the internal tubular body follows the longitudinal axis of the redirecting conduit, and the second position is the position where the distal end of the internal tubular body is redirected toward at least one lateral opening of the redirecting conduit. In some embodiments, the user then moves the guidewire distally to withdraw the guidewire from at least one lateral opening of the redirecting conduit 718. In some embodiments, once the guidewire is in place, the user can push the redirecting conduit into the correct position. In some embodiments, once in the correct position, the user retracts the guidewire, returning the internal tubular body to the rest position, and continues to guide the device to the desired position.

[0117] In this article, when referring to quantities or values, the term “about” means “within ±20%”.

[0118] The terms “comprises,” “comprising,” “includes,” “including,” “has,” “having,” and their cognates mean “including but not limited to.”

[0119] The phrase “consisting of” means “including and limited to”.

[0120] The term "consisting essentially of" means that the composition, method, or structure may include additional components, steps, and / or portions, provided that such additional components, steps, or portions do not materially alter the basic and novel features of the claimed composition, method, or structure.

[0121] As used herein, unless the context clearly specifies otherwise, the singular forms “a,” “an,” and “the” include plural references. For example, the terms “compound” or “at least one compound” can include a variety of compounds, including mixtures thereof.

[0122] Throughout this application, embodiments of the invention may be presented with reference to the scope format. It should be understood that the scope format is merely for convenience and brevity and should not be construed as a rigid limitation on the scope of the invention. Therefore, the description of a scope should be considered as specifically disclosing all possible sub-scopes and the individual numerical values ​​within those scopes. For example, a description of a scope such as "1 to 6" should be considered as specifically disclosing sub-scopes such as "1 to 3", "1 to 4", "1 to 5", "2 to 4", "2 to 6", "3 to 6", etc.; and the individual numbers within those scopes, such as 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the scope.

[0123] Whenever a range of numbers is indicated herein (e.g., “10-15”, “10 to 15”, or any pair of numbers linked by such other ranges), it means that any number (fraction or integer) within the indicated range boundary, including that range boundary, is included, unless the context explicitly states otherwise. The phrases “range / ranging / ranges” meaning “between” the first and second indicated numbers and “range / ranging / rangesfrom” meaning “to”, “up to”, “until”, or “through” (or another such range indication term) the second indicated number are used interchangeably herein and are intended to include the first and second indicated numbers and all fractions and integers in between.

[0124] Unless otherwise stated, the figures used herein and any ranges of figures based thereon are approximations within the reasonable range of measurement precision and rounding error as understood by those skilled in the art.

[0125] As used herein, the term "method" refers to the manner, means, techniques, and procedures used to accomplish a given task, including but not limited to those manner, means, techniques, and procedures known to practitioners in the fields of chemistry, pharmacology, biology, biochemistry, and medicine, or readily derived from known manner, means, techniques, and procedures.

[0126] It should be understood that, for clarity, certain features of the invention described in the context of a single embodiment may also be provided in combination in a single embodiment. Conversely, for brevity, various features of the invention described in the context of a single embodiment may also be provided individually, or in any suitable sub-combination, or appropriately provided in any other described embodiment of the invention. Certain features described in the context of various embodiments should not be considered as essential features of those embodiments unless the embodiment is inoperable without these elements.

[0127] The various embodiments and aspects of the invention as described above and claimed in the claims section below are experimentally / computationally supported in the following exemplary embodiments.

[0128] Exemplary Implementation Reference is now made to the following exemplary embodiments, which, together with the foregoing description, illustrate some embodiments of the invention in a non-limiting manner.

[0129] In some embodiments, the device is used as a re-entry microcatheter for one or more of the following: coronary arteries, peripheral arteries, cerebral vessels, aortic arch vessels, intra-abdominal vessels, and peripheral arteries (e.g., leg arteries, including the superficial femoral artery, popliteal artery, anterior tibial artery, etc.).

[0130] In some implementations, the device is used as a redirecting conduit as described above.

[0131] In some implementations, the common principle of both procedures is to facilitate the advancement of the guidewire at different angles into a branch or lateral vessel for treatment, such as balloon angioplasty, stenting, embolization devices (e.g., coils), and / or drug delivery (e.g., chemotherapy). In some implementations, the guidewire may not be able to reach the desired area due to acute angles or the presence of obstructive materials, such as stent struts. In some implementations, the guidewire must first pass through a branch or lateral vessel to deliver a balloon catheter, stent catheter, or microcatheter (or drug therapy, embolization coils, etc.).

[0132] For example: a. Example of coronary artery disease: i. The first example is an angulated large vessel, with the left anterior descending artery (LAD) or circumflex artery (Cx) angulated at the origin of the left main coronary artery, and a lesion located distal to the LAD or Cx.

[0133] ii. The second example is an angulated branch vessel, such as an angulated diagonal branch of the LAD, or an angulated obtuse marginal branch of the circumflex branch, or a distal branch of the right coronary artery (RCA).

[0134] iii. In the third example, after stent placement, the surgeon may wish to access the diagonal branch of the LAD following stent placement, or the blunt-edged branch of the Cx following stent placement. In this case, the guidewire often cannot be advanced into the branch vessel between the stent struts.

[0135] iv. The fourth instance involves an attempt to advance the guidewire into a coronary artery or bypass graft whose origin (also known as the sinus ostium) is difficult to access, and the guiding catheter cannot be engaged with the sinus ostium.

[0136] Other examples include: angulated lesions (where the guidewire cannot advance along the desired path), branch vessels passing through the stent strut, proximal caps of CTOs (where the initial penetration position is incorrect), and bypass grafts returning retrogradely to their own vessels.

[0137] b. Non-coronary artery examples: Due to excessive angle, access to branches of the aortic arch is required (e.g., left subclavian artery, left carotid artery, brachiocephalic artery), and intervention on branch vessels or branches of branch vessels is necessary. For example, if a right radial artery approach is performed after bypass surgery, and an attempt is made to inject the left internal mammary artery (LIMA) to check the patency of the bypass, access to the left subclavian artery via the right radial artery approach is difficult because the left subclavian artery is angulated during the procedure. Although it is possible to perform the surgery via the femoral artery approach, this may be highly undesirable for many reasons (very severe patient, severe peripheral vascular disease, etc.).

[0138] Other examples include: peripheral vessels (including abdominal and neck / brain vessels), angulated branching vessels, and the proximal cap of a CTO (where the initial penetration location was incorrect).

[0139] Other examples of 0.035mm redirecting microcatheters include treatment of the lower extremities, abdomen, supra-arch vessels (e.g., the left subclavian artery, left carotid artery, brachiocephalic artery, including the subclavian artery (LIMA) via the right radial artery approach), and proximal caps of CTOs (where the initial penetration position is incorrect). For example, due to the angulation at the aorta where the left subclavian artery originates, it is extremely difficult to perform a left internal mammary artery (LIMA) injection via the right radial artery approach to check LIMA patency in patients after bypass surgery. Although it is possible to perform the procedure via the femoral artery approach, this may be highly undesirable for many reasons (very severe patients, severe peripheral vascular disease, etc.).

[0140] Other examples include accessing specific arteries in the abdomen (e.g., the liver) for chemotherapy, or accessing endometrial arteries to treat leiomyomas (uterine fibroids). Sometimes, at the angulation point, even if the guidewire can advance, the microcatheter may fail to follow and prolapse. This also occurs in peripheral arteries: accessing the superficial femoral artery can be challenging, and the guidewire may only be able to engage the deep femoral artery.

[0141] c. Other examples include: chemotherapy administered via a specific artery in the abdomen (e.g., the liver), or treatment of leiomyomas (uterine fibroids) via an artery in the uterine lining.

[0142] Other uses of the present invention may include one or more of the following: LIMA angiography via the right radial artery approach; delivery of intraperitoneal chemotherapy drugs in tortuous arteries (hepatocellular carcinoma, liver metastases (colorectal cancer, pancreatic cancer, breast cancer), uterine fibroid embolization); coronary artery structural surgery, including access tocoronary sinus, coronary artery access after TAVI, and perivalvular leak rupture; intervention for peripheral artery disease with lower extremity tortuosity (especially below the knee); renal artery approach; traversal of chronic total occlusion (coronary and peripheral arteries); arteriovenous anastomosis; and traversal of atrial septal defects and ventricular septal defects (VSDs).

[0143] Although the invention has been described in conjunction with specific embodiments thereof, it will be apparent to those skilled in the art that many alternatives, modifications, and variations will be readily apparent. Therefore, the invention is intended to cover all such alternatives, modifications, and variations falling within the spirit and broad scope of the appended claims.

[0144] The applicant (one or more) intends that all publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety, just as each individual publication, patent, or patent application is specifically and separately indicated to be incorporated herein by reference. Furthermore, any reference to or identification of any prior art document in this application should not be construed as an admission that such prior art is prior art to the present invention. The use of section headings should not be construed as an inherent limitation. In addition, the entire contents of any priority documents (one or more) of this application are incorporated herein by reference.

Claims

1. A redirecting microcatheter, comprising: a. An external tubular body, comprising a first proximal end and a first distal end; b. At least one internal tubular body, the size and shape of which are adapted for insertion into the external tubular body; the internal tubular body includes a second proximal end and a second distal end; c. A dome head, which is connected to and extends distally therefrom the first distal end of the outer tubular body; the dome head includes a plurality of openings; d. At least one actuator for translating the second distal end of the inner tubular body from a non-actuated position to at least one actuated position, wherein in the non-actuated position the second distal end of the inner tubular body faces the first distal end, and in the actuated position the second distal end of the inner tubular body faces at least one of the plurality of openings of the dome head.

2. The redirecting conduit according to claim 1, wherein the dome head includes a distal region and a proximal region, the distal region including a small opening and the proximal region including a large opening.

3. The redirection catheter according to claim 1, wherein the dome head is non-invasive.

4. The redirecting duct according to claim 1, wherein the dome head is made of multiple metal wires.

5. The redirecting conduit of claim 1, wherein the at least one actuator includes at least one retainer coupled to a location adjacent to the second distal end of the inner tubular body, and the at least one actuator is coupled to the at least one retainer.

6. The redirecting conduit of claim 1, wherein the translation comprises bending the second distal end of the inner tubular body by an angle of about 1 degree to about 150 degrees.

7. The redirecting conduit of claim 1, wherein the translation comprises bending the second distal end of the inner tubular body at an angle of approximately 90 degrees.

8. The redirecting conduit of claim 1, wherein the outer tubular body is made of one or more of nylon, Pebax, polyurethane, metal, PTFE, and any combination thereof.

9. The redirecting conduit according to claim 1, wherein the outer tubular body is a braided / spring-wound shaft.

10. The redirecting conduit according to claim 1, wherein the length of the outer tubular body is from about 90 cm to about 180 cm.

11. The redirecting catheter of claim 1, wherein the outer tubular body is sized to pass through a 5F or 6F sheath.

12. The redirecting conduit according to claim 1, wherein the inner tubular body is made of a flexible material.

13. The redirecting conduit of claim 1, wherein at least a portion of the internal tubular body is made of a flexible material.

14. The redirecting conduit of claim 1, wherein at least the distal portion of the internal tubular body is made of a flexible material.

15. The redirecting conduit of claim 14, wherein the hardness of the flexible material of the inner tubular body is about 20D Shore to about 60D Shore.

16. The redirecting conduit of claim 1, wherein the inner tubular body is made of one or more of nylon, Pebax, polyurethane, metal, PTFE, and any combination thereof.

17. The redirecting conduit of claim 1, wherein the length of the internal tubular body is from about 100 mm to about 1800 mm.

18. The redirecting conduit according to claim 1, wherein the length of the inner tubular body is approximately the length of the outer tubular body.

19. The redirecting catheter of claim 1, wherein the inner tubular body is configured to be withdrawn from the outer tubular body, thereby allowing the insertion of other instruments into the outer tubular body.

20. The redirecting catheter of claim 1, wherein the inner tubular body is configured to allow other instruments to be inserted into itself without needing to be withdrawn from the outer tubular body.

21. The redirecting conduit of claim 1, wherein the at least one actuator is made of one or more of stainless steel, nickel-titanium alloy, cobalt-chromium alloy, nylon, PEEK and Dyneema.

22. The redirecting conduit according to claim 5, wherein the at least one retainer is a ring.

23. The redirecting conduit of claim 5, wherein the at least one retainer is positioned on the flexible portion of the inner tubular body.

24. The redirecting conduit of claim 5, wherein the at least one retainer is positioned at a distance of about 1 mm to about 20 mm from the second distal end.

25. The redirecting conduit of claim 5, wherein the at least one retainer is arranged around the inner tubular body.

26. The redirecting conduit of claim 5, wherein the at least one retainer is a groove on the surface of the inner tubular body.

27. The redirecting conduit of claim 5, wherein the at least one retainer is made of one or more of stainless steel, nickel-titanium alloy, cobalt-chromium alloy, nylon, PEEK, platinum-iridium alloy, and gold.

28. The redirection catheter according to any one of claims 1-2 to 19, wherein the size and shape of the internal tubular body allow for the insertion of at least one guidewire.

29. The redirecting conduit of claim 1, wherein the outer tubular body includes a first inner lumen, and the at least one actuator extends within the first inner lumen.

30. The redirecting conduit of claim 1, wherein the internal tubular body includes at least one second internal lumen, and the at least one actuator extends in the second internal lumen.

31. The redirecting catheter according to claim 1, wherein the internal tubular body includes a third internal lumen, and at least one guidewire is inserted into the third internal lumen.

32. The redirection conduit of claim 1, further comprising at least one handle located proximal to the redirection conduit, the handle being configured to receive one or more of the first proximal end of the outer tubular body, the second proximal end of the inner tubular body, and the third proximal end of the actuator.

33. The redirecting duct of claim 1, further comprising a stabilizer configured to prevent bending of the first distal end when the at least one actuator is actuated.

34. The redirection conduit of claim 33, wherein the stabilizer extends from the first proximal end to the first distal end.

35. The redirecting conduit of claim 33, wherein the stabilizer extends within the lumen of the outer tubular body.

36. The redirecting conduit of claim 33, wherein the stabilizer extends between the outer tubular body and the inner tubular body.

37. The redirecting conduit of claim 33, wherein the stabilizer extends within the lumen of the outer tubular body but outside the inner tubular body.

38. The redirecting conduit of claim 33, wherein the stabilizer is configured to extend beyond the distal opening when actuated.

39. A method for actuating a redirecting microcatheter according to claim 1 when using a guidewire, the method comprising: a. Retract the guidewire from the distal opening of the redirecting catheter; b. Actuate the internal tubular body to translate the second distal end of the internal tubular body from a non-actuated position to an actuated position, in which the second distal end of the internal tubular body faces the distal opening, and in the actuated position, the second distal end of the internal tubular body faces at least one of the plurality of openings of the dome head. c. Move the guidewire distally to exit the guidewire from at least one opening in the redirecting microcatheter.

40. The method of claim 39, further comprising inserting the redirecting microcatheter into the patient.

41. The method of claim 39, further comprising using the guidewire to guide the redirecting microcatheter toward a desired location to assist the guidance.

42. The method of claim 39, wherein the insertion further comprises inserting the guidewire into the redirecting microcatheter.

43. The method of claim 39, wherein the redirecting microcatheter has included the guidewire inserted therein.

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