Bendable guidewire lumen

Abstract

An aspect of some embodiments of the invention relates to a redirection microcatheter comprising an outer tubular body having a first proximal end and a first distal end, the first distal end having a distal end opening and at least one side opening, an inner tubular body sized and shaped to be inserted into the outer tubular body, the inner tubular body having a second proximal end and a second distal end located adjacent the at least one side opening, and at least one actuator for translating the second distal end of the inner tubular body from an unactuated position in which the second distal end of the inner tubular body faces the distal opening to an actuated position in which the second distal end of the inner tubular body faces one or more side openings of the outer tubular body.

Description

[Technical field]

[0001] Related Applications This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 341,431, filed May 13, 2022, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] The present invention, in some embodiments thereof, relates to catheters having a dedicated guidewire lumen, and more particularly, but not exclusively, to catheters having a bendable inner lumen.

[0003] Further background art includes U.S. Pat. No. 6,217,527 B1, which discloses a method and apparatus for crossing a completely or significantly occluded blood vessel by passing a redirectable wire, such as a guidewire, from a relatively proximal location beyond the occlusion in the subintimal space formed between the intimal and adventitial layers of the blood vessel wall. The wire may be advanced to a point distal to the occlusion and then deflected back into the vessel lumen, typically using a deflecting catheter that is advanced along the guidewire after being positioned in the subintimal space. The deflecting catheter may include a flapper valve assembly or a preformed actuator wire for redirection of the guidewire. After the guidewire is returned to the vessel lumen, the deflecting catheter may be retracted and the guidewire may be available for introduction of other interventional and diagnostic catheters to perform procedures such as stent placement.

[0004] US Patent Publication No. 20200282187A1 discloses an obturator including a hollow distal end portion including a distal end and a side hole located proximally from the distal end for receiving a guidewire and directing the guidewire laterally from the obturator.

[0005] US Patent No. 9,233,224 B1 discloses a medical device and method for accessing a side branch in an artery. The device includes a catheter having a side wall, an internal lumen, and a side port formed through the side wall. A perforated guidewire has a proximal portion within the internal lumen and a distal portion movably disposed from the side port. When the catheter is deployed at a site with the side port aligned with the branch artery, the guidewire can be delivered through the side port to the branch artery. In another embodiment, the catheter has inner and outer telescopic tubes with offset exit ports formed therein. The telescopic tubes can be used to change the relative positions of the offset exit ports to change the degree of deflection of the perforated guidewire.

[0006] US Patent Publication No. 20020055733A1 discloses a catheter assembly and method for delivering a guidewire into a blood vessel. The catheter assembly of the present invention features two guidewire lumens within a single catheter to prevent wire wrapping and wire crossing. A torque member is provided to assist in rotation of the catheter. The assembly allows for the delivery of wires into side branch vessels at steep angles to the main vessel. The assembly also provides for the delivery of two guidewires into the bifurcation.

[0007] US Patent Application Publication No. 20210236774A1 discloses a catheter that allows for selective direction of a surgical tool into multiple blood vessels of a patient. The catheter includes a catheter body having a main exit port and a side exit port. An internal balloon is provided within the catheter body. The internal balloon is inflatable and can be located at or near a distal portion of the side exit port. When deflated, the internal balloon allows the surgical tool to advance out of the main exit port past the side exit port. When inflated, the internal balloon directs the surgical tool to advance out of the side exit port instead of the main exit port.

[0008] US Patent Publication No. 20190091438A1 discloses a catheter including one or more side ports having a lumen and penetrating the elongate body of the catheter at a predetermined site. The one or more side ports may be positioned at an anatomical site of interest and a fluid, e.g., a drug, injected down the lumen of the catheter, and the fluid flows out of the one or more side ports to treat the anatomical site. Alternative embodiments may include a translatable inner sheath that may cover a portion of the one or more side ports and have an opening that may be aligned with at least one of the one or more side ports. The side ports may be opened and closed by an actuator, such as a push / pull wire or an electrically responsive shape memory material. A selective filter may be used to cover the side port, which may allow only fluids of a particular viscosity and / or molecular size to pass through the filter and the side port.

[0009] US9610438B2 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 surrounding surface. The catheter body defines a delivery lumen extending longitudinally within the catheter body. The side port is defined in an outer circumferential surface of the catheter body proximate the distal end and in communication with the delivery lumen. The electrode may be adjacent to and spaced apart from the side port. Techniques are also described for using the delivery catheter to identify a desired lead implantation site, e.g., via the electrodes, and to implant a medical lead or other implantable element at the desired site via the delivery lumen and the side port. Summary of the Invention

[0010] Below is a non-exhaustive list including some example embodiments of the present invention. The present invention also includes embodiments including fewer than all of the features in the example, and embodiments that use features from more than one example, even if not explicitly listed below.

[0011] Example 1.a. An outer tubular body having a first proximal end and a first distal end, the first distal end having a distal end opening and at least one side opening; b. an inner tubular body sized and shaped for insertion into said outer tubular body, said inner tubular body having a second proximal end and a second distal end, said second distal end positioned adjacent said at least one side opening; c. at least one actuator for translating the second distal end of the inner tubular body from an unactuated position in which the second distal end of the inner tubular body faces the distal opening to an actuated position in which the second distal end of the inner tubular body faces the one or more side openings of the outer tubular body; A redirection microcatheter comprising:

[0012] Example 2. The actuator includes at least one holder coupled to a portion of the inner tubular body adjacent to the second distal end, and at least one wire coupled to the at least one holder; The redirection catheter of Example 1, comprising:

[0013] Example 3. The translating includes bending the second distal end of the inner tubular body at an angle of from about 1 degree to about 150 degrees. A redirection catheter according to Example 1 or 2.

[0014] Example 4. The translating includes bending the second distal end of the inner tubular body at an angle of about 90 degrees. The redirection catheter according to any one of Examples 1 to 3.

[0015] Example 5. The at least one side opening is at a distance of about 0.5 mm to about 10 mm from the distal opening. The redirection catheter according to any one of Examples 1 to 4.

[0016] Example 6. The distal opening has a size of about 0.015" to about 0.1". The redirection catheter according to any one of Examples 1 to 5.

[0017] Example 7. The at least one side opening has a size of about 0.015" to about 0.1". The redirection catheter according to any one of Examples 1 to 6.

[0018] Example 8. The outer tubular body is made from one or more of nylon, Pebax, polyorithen, metal, PTFE, and any combination thereof. The redirection catheter according to any one of Examples 1 to 7.

[0019] Example 9. The outer tubular body is a braided / coiled shaft. The redirection catheter according to any one of Examples 1 to 8.

[0020] Example 10. The outer tubular body has a length of about 90 cm to about 180 cm. The redirection catheter according to any one of Examples 1 to 9.

[0021] Example 11. The outer tubular body is sized to pass through a 5F or 6F sheath. The redirection catheter according to any one of Examples 1 to 10.

[0022] Example 12. The outer tubular body includes a reinforced region located adjacent to and / or around the one or more side openings. The redirection catheter according to any one of Examples 1 to 10.

[0023] Example 13. The reinforced region includes one or more metal elements configured to increase the level of stiffness in the reinforced region. The redirection catheter described in Example 12.

[0024] Example 14. The inner tubular body is made of a flexible material. The redirection catheter according to any one of Examples 1 to 13.

[0025] Example 15. At least a portion of the inner tubular body is made from a flexible material. The redirection catheter according to any one of Examples 1 to 14.

[0026] Example 16. At least a distal portion of the inner tubular body is made of a flexible material. The redirection catheter according to any one of Examples 1 to 15.

[0027] Example 17. The flexible portion of the inner tubular body has a hardness of about 20D Shore to about 60D Shore. The redirection catheter according to any one of Examples 1 to 16.

[0028] Example 18. The inner tubular body is made of one or more of nylon, Pebax, polyurethane, metal, PTFE, and any combination thereof. The redirection catheter according to any one of Examples 1 to 17.

[0029] Example 19. The outer tubular body is a braided / coiled shaft. The redirection catheter according to any one of Examples 1 to 18.

[0030] Example 20. The inner tubular body has a length of about 100 mm to about 1800 mm. The redirection catheter according to any one of Examples 1 to 19.

[0031] Example 21. The inner tubular body has approximately the same length as the outer tubular body. The redirection catheter according to any one of Examples 1 to 20.

[0032] Example 22. The second distal end extends from the first distal end a distance of about 0.1 cm to about 1.5 cm. The redirection catheter according to any one of Examples 1 to 20.

[0033] Example 23. The inner tubular body is configured to be retracted from the outer tubular body to allow insertion of other instruments into the outer tubular body. The redirection catheter according to any one of Examples 1 to 21.

[0034] Example 24. The inner tubular body is configured to allow insertion of other instruments into the inner tubular body itself without having to be removed from the outer tubular body. The redirection catheter according to any one of Examples 1 to 23.

[0035] Example 25. The at least one actuator is made from one or more of stainless steel, nitinol, cobalt chrome, nylon, peek, and Dynema. The redirection catheter according to any one of Examples 1 to 24.

[0036] Example 26: The at least one holder is a ring. The redirection catheter according to any one of Examples 1 to 25.

[0037] Example 27. The at least one holder is positioned on the flexible portion of the inner tubular body. The redirection catheter according to any one of Examples 1 to 26.

[0038] Example 28. The at least one holder is positioned at a distance of about 1 mm to about 20 mm from the second distal end. The redirection catheter according to any one of Examples 1 to 27.

[0039] Example 29. The at least one holder is disposed around the inner tubular body. The redirection catheter according to any one of Examples 1 to 28.

[0040] Example 30. The at least one holder is a groove on a surface of the inner tubular body. The redirection catheter according to any one of Examples 1 to 28.

[0041] Example 31. The at least one holder is made from one or more of stainless steel, nitinol, cobalt chrome, nylon, PEEK, platinum iridium, and gold. The redirection catheter according to any one of Examples 1 to 29.

[0042] Example 32. The inner tubular body is sized and shaped to allow insertion of at least one guidewire into the inner tubular body. The redirection catheter according to any one of Examples 1 to 31.

[0043] Example 33. The outer tubular body comprises a first inner lumen through which the at least one actuator extends. The redirection catheter according to any one of Examples 1 to 32.

[0044] Example 34. The inner tubular body comprises a second inner lumen through which the at least one actuator extends. The redirection catheter according to any one of Examples 1 to 33.

[0045] Example 35. The inner tubular body comprises a third inner lumen through which the at least one guidewire is inserted. The redirection catheter according to any one of Examples 1 to 34.

[0046] Example 36. The catheter further comprises at least one handle located proximally within the redirection catheter 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. The redirection catheter according to any one of Examples 1 to 35.

[0047] Example 37. The device further comprises at least one marking configured to indicate a direction in which the one or more side openings face. The redirection catheter according to any one of Examples 1 to 36.

[0048] Example 38. The at least one marking is a radiopaque marking. The redirection catheter described in Example 37.

[0049] Example 39. The at least one marking is located at one or more of a site on the surface of the outer tubular body, a site on the surface of the first distal end of the outer tubular body, a site adjacent the one or more side openings, a site on the at least one actuator and a site on the at least one holder. The redirection catheter described in Example 37.

[0050] Example 40. The method further comprises a stabilizer configured to prevent bending of the first distal end when the at least one actuator is actuated. The redirection catheter according to any one of Examples 1 to 39.

[0051] Example 41. The stabilizer extends from the first proximal end to the first distal end. A redirection catheter as described in Example 40.

[0052] Example 42. The stabilizer extends into the lumen of the outer tubular body. A redirection catheter as described in Example 40.

[0053] Example 43. The stabilizer extends between the outer tubular body and the inner tubular body. A redirection catheter as described in Example 40.

[0054] Example 44. The stabilizer extends within the lumen of the outer tubular body and outside the inner tubular body. A redirection catheter as described in Example 40.

[0055] Example 45. The stabilizer is configured to extend beyond the distal end opening when actuated. A redirection catheter as described in Example 40.

[0056] Example 46. A method of actuating the redirection catheter described in Example 1 using a guidewire, comprising: a. retracting the guidewire from the distal opening of the redirection catheter; b. actuating the inner tubular body to translate the second distal end of the inner tubular body from an unactuated position in which the second distal end of the inner tubular body faces the distal opening to an actuated position in which the second distal end of the inner tubular body faces the one or more side openings of the outer tubular body; c. moving the guidewire distally so that the guidewire exits the at least one side opening of the redirection catheter; and A method comprising:

[0057] Example 47. The method further comprises inserting the redirection catheter into a patient. The method described in Example 46.

[0058] Example 48. The method further includes directing the redirection catheter toward a desired site using the guidewire to assist in directing the redirection catheter. The method according to Example 46 or 47.

[0059] Example 49. The inserting step further comprises inserting the guidewire into the redirection catheter. The method according to any one of Examples 46 to 48.

[0060] Example 50. The redirection catheter already includes the guidewire inserted into the redirection catheter. The method according to any one of Examples 46 to 49.

[0061] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will prevail. In addition, the materials, methods, and examples are merely illustrative and are not necessarily intended to be limiting. [Brief description of the drawings]

[0062] Some embodiments of the present invention are herein described, by way of example only, with reference to the accompanying drawings. Referring now specifically to the drawings in detail, it is emphasized that the details shown are by way of example and are intended for illustrative discussion of embodiments of the invention. In this regard, the description in conjunction with the drawings will make apparent to those skilled in the art how embodiments of the invention may be practiced. [Figure 1a] FIG. 1 is a schematic diagram of an exemplary redirection microcatheter, according to some embodiments of the present invention. [Figure 1b] FIG. 1 is a schematic diagram of an exemplary redirection microcatheter, according to some embodiments of the present invention. [Figure 1c] FIG. 1 is a schematic diagram of an exemplary redirection microcatheter comprising a reinforced region, according to some embodiments of the present invention. [Figure 1d] FIG. 1 is a schematic diagram of an exemplary redirection microcatheter comprising a reinforced region, according to some embodiments of the present invention. [Figure 1e] FIG. 1 is a schematic diagram of an exemplary redirection microcatheter comprising a reinforced region, according to some embodiments of the present invention. [Figure 2a] FIG. 1 is a schematic diagram of an exemplary redirection microcatheter with a guidewire, according to some embodiments of the present invention. [Figure 2b] FIG. 1 is a schematic diagram of an exemplary redirection microcatheter with a guidewire, according to some embodiments of the present invention. [Figure 3a] 1 is an exemplary multi-lumen redirection catheter according to some embodiments of the present invention. [Figure 3b] 1 is an exemplary multi-lumen redirection catheter according to some embodiments of the present invention. [Figure 4a] 1 is an exemplary multi-lumen redirection catheter according to some embodiments of the present invention. [Figure 4b] 1 is an exemplary multi-lumen redirection catheter according to some embodiments of the present invention. [Diagram 5] 1 is a flowchart of an exemplary method according to some embodiments of the present invention. [Figure 6a] 1 is a schematic diagram of an exemplary optional stabilizer according to some embodiments of the present invention. [Figure 6b]1 is a schematic diagram of an exemplary optional stabilizer according to some embodiments of the present invention. [Figure 7] 4 is a flowchart of an exemplary method of using an exemplary stabilizer according to some embodiments of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0063] The present invention, in some embodiments thereof, relates to catheters having a dedicated guidewire lumen, and more particularly, but not exclusively, to catheters having a bendable inner lumen.

[0064] overview An 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 side openings. In some embodiments, there are two or more side openings, and the user can select which side opening to use. In some embodiments, the redirection catheter comprises an inner tube located inside the redirection catheter, configured to be directed toward one or more side openings while the redirection catheter does not turn. In some embodiments, the one or more side openings are large enough to allow the passage of one or more of a guidewire, a balloon catheter, a stent catheter, an interventional instrument, and a drug release device. In some embodiments, the inner tube can be oriented at an angle of about 1 degree to about 150 degrees, preferably about 90 degrees, relative to the longitudinal axis of the redirection catheter. In some embodiments, the redirection catheter is reinforced in the area where the redirection of the inner tube occurs. In some embodiments, the reinforcement is achieved by adding a metal insert to the outer tube. In some embodiments, the reinforcement is added throughout the area including the side openings. In some embodiments, the reinforcement is added at a selected site near or adjacent to the side opening. In some embodiments, the reinforcement avoids undesired bending of the outer tube at the site of the side opening. In some embodiments, the redirection catheter comprises a stabilizer. In some embodiments, the stabilizer is configured to avoid undesired bending of the distal end of the outer tube when the inner tube is bent to allow redirection of the guidewire through the side opening. In some embodiments, the stabilizer is a wire that extends within the lumen of the outer tube from the proximal end of the outer tube to the distal end of the outer tube. 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 the distal opening of the outer tube.In some embodiments, the stabilizer has sufficient rigidity to prevent the distal end of the outer tube from bending when the inner tube is bent.

[0065] Before describing at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of components and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0066] Reference is now made to FIGS. 1a-1b, which show schematic diagrams of an exemplary redirection microcatheter 100, according to some embodiments of the present invention. In some embodiments, the redirection microcatheter 100 comprises an outer tubular body 102 having 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 comprises a distal opening 108 located at the distal end 106 of the outer tubular body 102, and at least one side opening 110 (referred to herein simply as "side opening 110" and referred to in the singular, although it should be understood that the scope of the present invention encompasses more than one side opening) located adjacent to and proximal to the distal end 106 of the outer tubular body 102. In some embodiments, the outer tubular body 102 comprises one side opening 110. In some embodiments, the outer tubular body 102 comprises two side openings 110. In some embodiments, the outer tubular body 102 comprises three or more side openings 110. In some embodiments, optionally, the distal opening 108 and / or one or more of the side openings 110 are large enough to allow passage of one or more of a guidewire (a 0.035 mm guidewire or a 0.018 mm guidewire or a 0.014 mm guidewire), an inner tubular body (see below), a balloon catheter, a stent catheter, and a microcatheter.

[0067] In some embodiments, the distal opening 108 has a size (or diameter) of about 0.015" to about 0.1". For example, the distal opening 108 has a size of 0.015", 0.02", 0.036", 0.04", 0.055", 0.084", 0.09".

[0068] In some embodiments, the side opening 110 has a size (or diameter) of about 0.015" to about 0.1". For example, the side opening 110 has a size of 0.015", 0.02", 0.036", 0.04", 0.055", 0.084", 0.09".

[0069] In some embodiments, the side opening 110 is located at a distance of about 0.5 mm to about 10 mm from the distal opening 108. Optionally, the side opening 110 is located at a distance of about 0.3 mm to about 20 mm from the distal opening 108. Optionally, the side opening 110 is located at a distance of about 0.1 mm to about 50 mm from the distal opening 108.

[0070] In some embodiments, the outer tubular body 102 is made from one or more of nylon, Pebax, polyorithen, metal, PTFE, and any combination thereof. In some embodiments, the outer tubular body is a braided / coiled shaft.

[0071] In some embodiments, the outer tubular body 102 has a length of about 90 cm to about 180 cm. Optionally, the outer tubular body 102 has a length of about 80 cm to about 200 cm. Optionally, the outer tubular body 102 has a length of 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.

[0072] In some embodiments, the redirection microcatheter 100 comprises an inner tubular body 112 comprising a proximal end 114 and a distal end 116. In some embodiments, the proximal end 114 of the inner tubular body 112 is connected to an actuation handle (not shown). In some embodiments, the distal end 116 of the inner tubular body 112 extends distally to near the site of the side opening 110. In some embodiments, the inner tubular body 112 is made from a flexible material. In some embodiments, at least a portion of the inner tubular body 112 is made from a flexible material. In some embodiments, at least a distal portion of the inner tubular body 112 is made from a flexible material.

[0073] In some embodiments, the flexible portion of the inner tubular body 112 has a hardness of about 20 A shore to about 60 A shore, optionally about 10 A shore to about 75 A shore, optionally about 0 A shore to about 100 A shore, such as 70 A shore, 50 A shore, 25 A shore. In some embodiments, the flexible portion of the inner tubular body 112 has a hardness of about 20 D shore to about 60 D shore, optionally about 10 D shore to about 75 D shore, optionally about 0 D shore to about 100 D shore, such as 55 D shore, 40 D shore, 25 D shore.

[0074] In some embodiments, the inner tubular body 112 is made from one or more of nylon, Pebax, polyurethane, metal, PTFE, and any combination thereof. In some embodiments, the outer tubular body is a braided / coiled shaft.

[0075] In some embodiments, the inner tubular body 112 has a length of about 100 mm to about 1800 mm. Optionally, the inner tubular body 112 has a length of about 50 mm to about 2000 mm. Optionally, the inner tubular body 112 has a length of about 25 mm to about 2500 mm. In some embodiments, the inner tubular body 112 has about the same length as the outer tubular body 102.

[0076] In some embodiments, the distal end 116 of the inner tubular body 112 extends from the proximal end of the device a distance of from about 0.1 cm to about 1.5 cm from the distal end 106 of the outer tubular body 102 .

[0077] In some embodiments, the inner tubular body 112 is configured to be retracted from the redirection microcatheter 100 to allow for the insertion of other instruments into the redirection microcatheter 100. In some embodiments, the inner tubular body 112 is configured to allow for the insertion of other instruments into the inner tubular body 112 itself without requiring the removal of the inner tubular body 112.

[0078] In some embodiments, the redirection microcatheter 100 comprises an actuator 118. In some embodiments, the actuator 118 is a wire. In some embodiments, the actuator 118 is a push-pull wire. In some embodiments, the actuator 118 is made from one or more of stainless steel, nitinol, cobalt chrome, nylon, peek, and Dynema.

[0079] In some embodiments, the actuator 118 comprises a proximal end 120 and a distal end 122. In some embodiments, the proximal end 120 of the actuator 118 extends to the inside of an actuation handle (not shown) to an actuation mechanism, which is described further below. In some embodiments, the distal end 122 of the actuator 118 is connected to a holder 124 (see below) located adjacent the distal end 116 of the inner tubular body 112.

[0080] In some embodiments, the redirection microcatheter 100 comprises a holder 124. In some embodiments, the holder 124 is connected to the inner tubular body 112 at a location adjacent the distal end 116 of the inner tubular body 112. In some embodiments, the holder 124 is connected to at least a portion of the flexible portion of the inner tubular body 112. In some embodiments, the location of the holder 124 is about 1 mm to about 20 mm from the distal end 116 of the inner tubular body 112. Optionally, the location of the holder 124 is about 0.5 mm to about 40 mm from the distal end 116 of the inner tubular body 112. Optionally, the location of the holder 124 is about 0.1 mm to about 60 mm from the distal end 116 of the inner tubular body 112.

[0081] In some embodiments, the holder 124 is a ring or band. In some embodiments, the holder 124 is disposed around the inner tubular body 112. In some embodiments, the holder 124 is a groove on the surface of the inner tubular body 112, and the distal end 122 of the actuator is positioned within the groove.

[0082] In some embodiments, the holder 124 is made from one or more of stainless steel, nitinol, cobalt chrome, nylon, PEEK, platinum iridium, and gold.

[0083] In some embodiments, actuation of the actuator 118 translates a portion of the distal end 116 of the inner tubular body 112 from a first position to a second position. In some embodiments, the first position is a resting position in which the portion of the distal end 116 of the inner tubular body 112 is not actuated and the distal end 116 of the inner tubular body 112 is aligned with the longitudinal axis 126 of the redirection microcatheter 100, as shown, for example, in FIG. 1a. In some embodiments, the second position is an actuated position in which the portion of the distal end 116 of the inner tubular body 112 is actuated and is directed (see arrow 128) from the longitudinal axis 126 toward and / or toward the side opening 110, as shown, for example, in FIG. 1b. A push-pull wire is illustratively used as an exemplary actuator for the following description. It should be understood that this is done to enable those skilled in the art to understand the present invention, but is in no way a limitation of the present invention. In some embodiments, the push-pull wires actuate the inner tubular body 112 from a first position to a second position (or from an un-actuated position to an actuated position). In some embodiments, the push-pull wires actuate the inner tubular body 112 from a second position to a first position (or from an actuated position to an un-actuated position). In some embodiments, the natural state of the inner tubular body 112 is in a rest position (un-actuated position), and during actuation, the inner tubular body 112 "wants" to return to the rest position. Thus, in some embodiments, actuation of the inner tubular body 112 involves actively translating a portion of the distal end 116 of the inner tubular body 112 from a rest position to an actuated position by pulling on the push-pull wires and holding them taut until actuation is no longer required. Then, in some embodiments, releasing and / or reducing tension on the push-pull wires allows the inner tubular body 112 to return to its natural rest position.

[0084] In some embodiments, the translation during actuation is from about 1 degree to about 90 degrees relative to the longitudinal axis of the longitudinal axis 126 of the redirection microcatheter 100. Optionally, the translation during actuation is from about 1 degree to about 150 degrees relative to the longitudinal axis of the longitudinal axis 126 of the redirection microcatheter 100. Optionally, the translation during actuation is from about 1 degree to about 170 degrees relative to the longitudinal axis of the longitudinal axis 126 of the redirection microcatheter 100.

[0085] Reference is now made to FIGS. 1c-1e, which show schematic diagrams of an exemplary redirection microcatheter 100 with a reinforced region, according to some embodiments of the present invention. In some embodiments, in the region around the side opening 110, the redirection microcatheter 100 comprises a reinforced region 130. In some embodiments, the reinforced region comprises one or more metal elements that impart a certain level of stiffness to the reinforced region, which is higher than the level of stiffness of the region without the metal elements. For example, the outer tubular body 102 may be made of a bendable material (e.g., Pebax), and the reinforced region may comprise a metal braid embedded within the outer tubular body 102 and extending across the region around the side opening 110, as shown, for example, in FIG. 1e. In some embodiments, the metal element may have any suitable form, and may be, for example, a metal braid, a metal scaffold, a metal rod, a metal ring, or the like. In some embodiments, the metal element is located in a portion of the outer tubular body 102. This means that not all the region around the side opening 110 is reinforced. For example, the reinforcement region may face the side opening 110, such as at two locations near the side opening 110. In some embodiments, the reinforcement region 130 does not block the side opening 110. In some embodiments, a potential advantage of having the reinforcement region 130 around the side opening 110 is to potentially avoid undesired bending of the outer tubular body 102 due to forces applied when actuating the inner tubular body 112 to redirect a device located within the inner tubular body 112. In some embodiments, the reinforcement region 130 is also present in the embodiments disclosed in Figures 2a-b, 3a-b, and 4a-b.

[0086] Reference is now made to Figures 2a-b, which show schematic diagrams of an exemplary redirection microcatheter 100 having a guidewire 202, according to some embodiments of the present invention. In some embodiments, the inner tubular body 112 allows for the insertion of the guidewire 202 within the inner tubular body 112. This is used, for example, to direct the redirection microcatheter 100 to a desired site. In some embodiments, the redirection microcatheter 100 is configured to allow for the insertion of the guidewire 202 within the inner tubular body 112 and the removal of the guidewire 202 within the inner tubular body 112. In some embodiments, the distal end of the guidewire 202 can exit the inner tubular body 112 and the distal end 106 of the redirection microcatheter 100 using the distal opening 108, for example, as shown in Figure 2a. Hereinafter, this is referred to as "distal exiting" of the guidewire. In some embodiments, this is possible when the inner tubular body 112 is in a resting position. In some embodiments, upon actuation, the distal end of the guidewire 202 can exit the inner tubular body 112 and the redirection microcatheter 100 using the side opening 110, for example, as shown in FIG. 2b. This is hereafter referred to as "side exiting" of the guidewire. In some embodiments, passing the guidewire 202 from the distal exit to the side exit and from the side exit to the distal exit requires that the guidewire 202 be inserted into the inner tubular body 112 prior to actuation of the inner tubular body 112 from one configuration (actuated or non-actuated) to another configuration.

[0087] In some embodiments, the guidewire 202 can be a 0.035 mm guidewire, a 0.018 mm guidewire, a 0.014 mm guidewire, or a 0.009 guidewire.

[0088] Exemplary Multi-Lumen Redirection Microcatheter Reference is now made to Figures 3a-b, which illustrate an exemplary multi-lumen redirection catheter 200, according to some embodiments of the present invention. In some embodiments, one or more of the above-disclosed components are incorporated within a dedicated lumen, optionally within a dedicated lumen of a dedicated elongate member, e.g., a tube.

[0089] For example, in some embodiments, the actuator 118 is incorporated into a dedicated tube 302 that extends from the proximal end 104 of the outer tubular body 102 to a location adjacent to the holder 124. In some embodiments, the dedicated tube 302 extends within the outer tubular body 102 and into a zone outside the inner tubular body 112.

[0090] As another example, in some embodiments, the guidewire 202 is incorporated into a dedicated tube 304 that extends from the proximal end 104 of the inner tubular body 112 to a location adjacent the distal end 116 of the inner tubular body 112. In some embodiments, the dedicated tube 304 extends into a zone within the inner tubular body 112.

[0091] Reference is now made to FIGS. 4a-b, which illustrate another exemplary multi-lumen redirection catheter 300, according to some embodiments of the present invention. In some embodiments, the actuator 118 is incorporated into a dedicated tube 402 that extends from the proximal end 104 of the outer tubular body 102 to a location adjacent to the holder 124. In some embodiments, the dedicated tube 402 extends to a zone within the inner tubular body 112. Additionally, in some embodiments, the guidewire 202 is incorporated into a dedicated tube 404 that extends from the proximal end 104 of the inner tubular body 112 to a location adjacent to the distal end 116 of the inner tubular body 112. In some embodiments, the dedicated tube 404 extends to a zone within the inner tubular body 112.

[0092] Exemplary Handle In some embodiments, the device comprises a handle at the proximal end. In some embodiments, the handle comprises a dedicated mechanism for actuating one or more features of the catheter, as known in the art. In some embodiments, the handle comprises an actuator to which a push-pull wire is connected. In some embodiments, the user actuates the actuator to cause tension on the push-pull wire, translating the inner tubular body towards one or more side openings. In some embodiments, the user actuates the actuator again to release and / or push the push-pull wire, thereby translating the inner tubular body back to its original position opposite the distal opening of the device. In some embodiments, the actuator includes two modalities: a free actuation mode, where the user is free to actuate the actuator from one position to another, and a half-locked actuation mode, where actuation of the actuator is stepped, e.g., each time the user actuates the actuator, the inner tubular body is translated a fixed amount, e.g., 10 degrees. In some embodiments, this means, for example, that the user needs to actuate the actuator 9 times to move the inner tubular body to an angle of 90 degrees. In some embodiments, in the half-locked actuation mode, after each actuation step the actuator remains in the last actuated position, while in some embodiments, in the free actuation mode, the user holds the actuator and maintains tension in the push-pull wires by releasing the actuator, thereby allowing the inner tubular body to return to the resting, unactuated position.

[0093] Exemplary Methods Reference is now made to FIG. 5, which illustrates a flow chart of an exemplary method, according to some embodiments of the present invention. In some embodiments, a user inserts a redirection catheter into a patient (502). In some embodiments, a user inserts a guidewire into the redirection catheter (504). In some embodiments, the guidewire is already in the redirection catheter when the redirection catheter is inserted into the patient. In some embodiments, the user directs the redirection catheter toward the desired site (506) using known methods to aid in the orientation of the redirection catheter, optionally using a guidewire to direct the redirection catheter. In some embodiments, at this point, a guidewire is present in the redirection catheter using the distal opening of the redirection catheter. In some embodiments, at some point in the orientation, the user evaluates whether a reorientation of the redirection catheter is necessary (508). In some embodiments, if the answer is no, the user continues directing the redirection catheter (510). In some embodiments, if the answer is YES, the user moves the guidewire proximally (512) until the distal end of the guidewire reaches the inner tubular body. In some embodiments, when the distal end of the guidewire is within the inner tubular body, the user actuates the inner tubular body (514) to translate the distal end of the inner tubular body from a first position, where the inner tubular body follows the longitudinal axis of the redirection catheter, to a second position, where a redirection of the distal end of the inner tubular body occurs toward at least one side opening of the redirection catheter. In some embodiments, the user then moves the guidewire distally (516) to cause the guidewire to exit at least one side opening of the redirection catheter. In some embodiments, when the guidewire is in place, the user can push the redirection catheter to enter the correct site.In some embodiments, when at the correct site, the user retracts the guidewire, returning the inner tubular body to a resting position and continuing to direct the device to the desired site.

[0094] Exemplary markings In some embodiments, the exemplary redirection catheter includes one or more markings to assist a user in identifying the direction in which the side opening 110 faces. For example, a radiopaque marker is positioned adjacent the side opening 110 and is visible using known visualization techniques. In another example, the side opening 110 is marked with, for example, a semicircle or full circle surrounding the opening itself. In some embodiments, radiopaque markings are added both on the surface of the outer tubular body 102 as dots (for example) and around the opening itself.

[0095] In some embodiments, elements of the redirection catheter may be made from or populated with radiopaque material. For example, one or more of the actuator 118 of the redirection mechanism, the holder 124, and the dedicated ring located at the distal-most end of the outer tubular body 102 may be made from or populated with radiopaque material. In some embodiments, a potential advantage of marking the actuator 118 is to provide a "line" that directly indicates the direction of the opening.

[0096] In some embodiments, additionally or alternatively, the redirection catheter includes markings on the handle that indicate to the user the direction in which the side opening 110 is facing.

[0097] In some embodiments, additionally or alternatively, the redirection catheter comprises an actuation element on the handle that, when actuated, performs the redirecting action, hi some embodiments, the location of the actuation element on the handle is located on the same side as the opening, thereby indicating to the user the direction in which the opening is facing.

[0098] Exemplary Optional Stabilizer Reference is now made to Figures 6a-b, which illustrate an exemplary optional stabilizer, according to some embodiments of the present invention. In some embodiments, the exemplary redirection catheter 600 optionally comprises a stabilizer 602. In some embodiments, the stabilizer 602 comprises a wire that extends from the proximal-most end 104 to the distal-most 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 comprises its own dedicated tube (not shown) or simply runs within the lumen of the outer tubular body 102, similar to the inner tubular body 112.

[0099] In some embodiments, the stabilizer 602 is a metal wire. In some embodiments, the stabilizer 602 has a diameter of about 150 micrometers to about 0.5 mm, and in some embodiments, the stabilizer 602 has a strength high enough to stop the outer tube from bending when the redirection catheter is actuated, but low enough so as not to affect the flexibility of the outer tube, and therefore the flexibility of the redirection catheter.

[0100] In some embodiments, during operation of the redirection catheter 600, if the user wants to use the distal-most opening 108 of the outer tubular body 102 as an exit point for the guidewire 202, i.e., the distal exit of the guidewire 202, the stabilizer 602 is retained within the lumen of the outer tubular body 102 (inactive state of the stabilizing element), as shown diagrammatically in FIG. 6a.

[0101] In some embodiments, as described above, during operation of the redirection catheter 600, if the user desires to redirect the guidewire 202 so that it exits through the side opening 110, i.e., for side exit, the user must cause a curvature of the inner tubular body 112 towards the side opening 110 by actuating the actuator 118. In some embodiments, before or during the act of actuating the redirection mechanism, the user "activates" the stabilizing mechanism (active state of the stabilizing element) by causing the stabilizer 602 to exit the lumen of the outer tubular body 102 through the distal-most opening 108 of the outer tubular body 102, as shown diagrammatically in FIG. In some embodiments, the stabilizer 602 is activated by pushing the stabilizer 602 forward in the direction of the distal end of the redirection catheter, and the stabilizer 602 is deactivated by pulling the stabilizer 602 back in the direction of the proximal end of the redirection catheter.

[0102] In some embodiments, a potential advantage of having the stabilizer 602 is to potentially avoid bending of the outer tubular body 102 during operation of the redirection mechanism, i.e., bending of the inner tubular body 112 during the act of redirection.

[0103] Exemplary Methods Having Stabilizing Elements Reference is now made to FIG. 7, which illustrates a flow chart of an exemplary method of using a stabilizer, according to some embodiments of the present invention. In some embodiments, a user inserts a redirection catheter into a patient (702). In some embodiments, a user inserts a guidewire into the redirection catheter (704). In some embodiments, the guidewire is already in the redirection catheter when the redirection catheter is inserted into the patient. In some embodiments, a user directs the redirection catheter toward a desired site (706) using known methods to aid in the orientation of the redirection catheter, optionally using a guidewire to direct the redirection catheter. In some embodiments, at this point, a guidewire is present in the redirection catheter using the distal opening of the redirection catheter. In some embodiments, at some point in the orientation, a user evaluates whether a reorientation of the redirection catheter is necessary (708). In some embodiments, if the answer is no, the user continues directing the redirection catheter (710). In some embodiments, if the answer is YES, the user moves the guidewire proximally (712) until the distal end of the guidewire reaches the inner tubular body. In some embodiments, when the distal end of the guidewire is within the inner tubular body, the user actuates the stabilizer (714) by causing the stabilizer to exit through the distal end of the outer tubular body. In some embodiments, after activation of the stabilizer, the user actuates the inner tubular body (716) to translate the distal end of the inner tubular body from a first position, where the inner tubular body follows the longitudinal axis of the redirection catheter, to a second position, where a redirection of the distal end of the inner tubular body occurs toward at least one side opening of the redirection catheter. In some embodiments, the user then moves the guidewire distally (718) to cause the guidewire to exit at least one side opening of the redirection catheter.In some embodiments, once the guidewire is in place, the user can push the redirection catheter to enter the correct site, in some embodiments, once in the correct site, the user retracts the guidewire, returning the inner tubular body to a resting position and continuing to direct the device to the desired site.

[0104] As used herein in reference to an amount or value, the term "about" means "within ±20% of."

[0105] The words "comprises," "comprising," "includes," "including," "has," "having" and their conjugations mean "including but not limited to."

[0106] The term "consisting of" means "including and limited to."

[0107] "Consisting essentially of" means that the composition, method, or structure may include additional components, steps, and / or moieties, but only if the additional components, steps, and / or moieties do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0108] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" can include a plurality of compounds, including mixtures thereof.

[0109] Throughout this application, embodiments of the present invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the present invention. Thus, the description of a range should be considered to specifically disclose all possible subranges as well as individual numerical values ​​within that range. For example, the description of a range such as "1 to 6" should be considered to specifically disclose subranges such as "1 to 3", "1 to 4", "1 to 5", "2 to 4", "2 to 6", "3 to 6", etc. within that range, as well as individual numbers, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0110] When a numerical range is given herein (e.g., any pair of numbers connected by "10 to 15 (10-15)", "10 to 15 (10 to 15)", or other similar range designation), it is meant to include any number (fractional or integer) within the limits of the given range, including the limits of the range, unless the context clearly indicates otherwise. The phrase "range / ranging / ranges between" a first given number and a second given number, and the phrase "range / ranging / ranges from" a first given number "to", "up to", "until" or "through" a second given number are used interchangeably herein and are meant to include the first given number, the second given number, and all fractional and integer numbers therebetween.

[0111] Unless otherwise indicated, numbers used herein, and any numerical ranges based thereon, are approximations within the accuracy of reasonable measurement and rounding errors, as will be understood by one of ordinary skill in the art.

[0112] As used herein, the term "method" refers to methods, means, techniques, and procedures for accomplishing a given task, including, but not limited to, methods, means, techniques, and procedures that are known to the practitioner of chemistry, pharmacology, biology, biochemistry, and medicine, or that are readily developed from known methods, means, techniques, and procedures by the practitioner of chemistry, pharmacology, biology, biochemistry, and medicine.

[0113] It is understood that certain features of the invention that are described for clarity in the context of separate embodiments may also be provided in combination in a single embodiment. Conversely, various features of the invention that are described for brevity in the context of a single embodiment may also be provided separately or in any suitable subcombination or as preferred in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be construed as essential features of those embodiments, unless the embodiment is inoperable without those elements.

[0114] Various embodiments and aspects of the present invention as delineated hereinabove and as claimed in the claims section below find experimental / computational support in the following exemplary embodiments.

[0115] Exemplary embodiments Reference is now made to the following exemplary embodiments, which together with the above description illustrate some embodiments of the present invention in a non-limiting manner.

[0116] In some embodiments, the device is used as a re-entry microcatheter for chronic total occlusions (CTOs) in one or more of the coronary arteries, peripheral arteries, cerebral vessels, aortic arch vessels, intraperitoneal vessels, and peripheral arteries (e.g., arteries of the legs including the superficial femoral artery, popliteal artery, anterior tibial artery, etc.).

[0117] In some embodiments, the device is used as a redirection catheter, as disclosed above.

[0118] In some embodiments, the principle common to both procedures is to facilitate the advancement of a guidewire over different angulations into a branch or side vessel to allow treatment such as balloon angioplasty, embolic devices such as stents, coils, and / or drug delivery (e.g., chemotherapy). In some embodiments, the guidewire cannot enter the desired area due to a sharp bend or the presence of some occluding material such as stent struts. In some embodiments, to deliver a balloon catheter, stent catheter, or microcatheter (or drug therapy, embolic coils, etc.), the guidewire must first pass through the branch or side vessel.

[0119] For example, A. Example of coronary artery i. The first example is an angulated great vessel, the angulated origin of the left anterior descending artery (LAD) or circumflex artery (Cx) from the left main coronary artery, with a lesion distal to the LAD or Cx. ii. The second example is a tortuous branching vessel, a tortuous diagonal branch of the LAD, or a tortuous obtuse marginal branch of the circumflex or distal branch of the right coronary artery (RCA). iii. A third example is when, after placing a stent, the operator wants to access the diagonal side branch of a stented LAD or the obtuse marginal branch of a stented Cx. The guidewire may not be able to advance between the struts of the stent and into the branch vessel. iv. A fourth example is when attempting to advance a guidewire into a coronary artery or bypass graft that has difficult-to-access origins (also called ostia), where the guiding catheter is unable to engage the ostium.

[0120] Other examples include tortuous lesions where the guidewire does not advance in the desired path, branching vessels passing between stent struts, the proximal cap of a CTO where the initial penetration is not in the correct place, and retrograde backing into the parent vessel with a bypass graft.

[0121] b. Non-coronary examples: When accessing a branch of the aortic arch (e.g., left subclavian artery, left carotid artery, brachiocephalic artery) due to extreme angulation and intervention is required on a branch vessel or a branch of a branch vessel. For example, when performing a right radial approach on a patient after bypass surgery and attempting a left internal thoracic artery (LIMA) infusion to confirm bypass patency, it is difficult to access the left subclavian artery via the right radial approach due to the tortuosity of the left subclavian artery via this approach. Cases via femoral artery approach are possible but may be highly undesirable for many reasons (very critically ill patients, severe peripheral vascular disease, etc.).

[0122] Other examples include peripheral vessels (including abdominal and cervical / intracranial vessels), tortuous branch vessels, and the proximal cap of a CTO where the initial penetration is not in the correct place.

[0123] In addition, other examples of 0.035 mm redirection microcatheters include treatment in the lower extremities, abdomen, arch vessels (e.g., right radial approach, including the subclavian artery (LIMA), left subclavian artery, left carotid artery, brachiocephalic artery), and proximal cap of CTO where initial penetration is not in the correct location. For example, right radial approach for patients after bypass surgery is extremely difficult to access left internal mammary artery (LIMA) infusion to confirm LIMA patency due to the tortuosity of the left subclavian artery from the aorta. Cases with femoral artery approach are possible but may be highly undesirable for many reasons (very critically ill patients, severe peripheral vascular disease, etc.).

[0124] Further examples include accessing certain abdominal (e.g., liver) arteries for chemotherapy delivery, and endometrial arteries for treatment of leiomyomas (fibroids). Angulated take-offs may allow the guidewire to advance, but the microcatheter may not follow and may prolapse. Also, in peripheral arteries, access to the superficial femoral artery may be difficult, with only the guidewire engaging the deep femoral artery.

[0125] c. Further examples include accessing certain arteries in the abdomen (e.g., liver) for delivery of chemotherapy, and accessing endometrial arteries for treatment of leiomyomas (fibroids).

[0126] Further applications of the present invention include LIMA angiography via right radial approach, delivery of intraperitoneal chemotherapy in tortuous arteries (hepatocellular carcinoma, liver metastatic disease (colon cancer, pancreatic cancer, breast cancer), uterine fibroid embolization), access to the coronary sinuses, coronary artery access after TAVI, coronary structural procedures including paravalvular leak crossing, peripheral artery disease interventions with lower limb tortuosity (especially below the knee), renal artery access, chronic total occlusion crossing (coronary and peripheral arteries), creation of arterial-venous anastomoses, crossing of atrial septal defects, patent foramen ovale and ventricular septal defects (VSD).

[0127] While the present invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0128] It is the intention of the applicants (applicants) that all publications, patents, and patent applications mentioned herein are incorporated herein by reference in their entirety as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated herein by reference. Furthermore, citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not necessarily be construed as limiting. Additionally, any priority document(s) of this application are hereby incorporated herein by reference in their entirety.

Claims

1. A redirection microcatheter having a tubular body, The tubular body is, a. A guide wire lumen extending between the proximal and distal ends of the tubular body, b. At least one actuator configured to actively and selectively bend the distal portion of the guidewire lumen, Define the area, The tubular body comprises a distal opening and at least one side opening that communicates fluidly with the guide wire lumen, The distal portion of the guidewire lumen is such that the guidewire inserted into the guidewire lumen can selectively exit through either the distal opening or the at least one side opening. (i) From the first configuration in which the guidewire lumen is aligned with the distal opening, (ii) Up to a second configuration in which the guidewire lumen is directed toward the at least one side opening, It is configured to bend actively and selectively, The actuator comprises at least one holder connected to a portion adjacent to the distal portion of the guidewire lumen, and at least one wire connected to the at least one holder. Redirection microcatheter.

2. The bending described above includes bending the distal portion of the guidewire lumen at an angle ranging from approximately 1 degree to approximately 150 degrees. The redirection microcatheter according to claim 1.

3. The bending described above includes bending the distal portion of the guide wire lumen at an angle of approximately 90 degrees. The redirection microcatheter according to claim 1.

4. The at least one lateral opening is located at a distance of approximately 0.5 mm to approximately 10 mm from the distal opening. The redirection microcatheter according to claim 1.

5. The distal opening has a size ranging from approximately 0.015" to approximately 0.1" The redirection microcatheter according to claim 1.

6. The at least one side opening has a size ranging from about 0.015" to about 0.1" The redirection microcatheter according to claim 1.

7. The tubular body is made from one or more of the following: nylon, Pebax, polyurethane, metal, PTFE, and any combination thereof. The redirection microcatheter according to claim 1.

8. The tubular body is a braided / coiled shaft. The redirection microcatheter according to claim 1.

9. The tubular body has a length ranging from approximately 90 cm to approximately 180 cm. The redirection microcatheter according to claim 1.

10. The tubular body has a size that allows it to pass through the 5F or 6F sheath. The redirection microcatheter according to claim 1.

11. The tubular body comprises reinforcing regions adjacent to and / or around the one or more side openings. The redirection microcatheter according to claim 1.

12. The reinforcing region includes one or more metal elements configured to increase the rigidity in the reinforcing region. The redirection microcatheter according to claim 11.

13. The at least one actuator is made from one or more of the following materials: stainless steel, nitinol, cobalt-chromium, nylon, PEEK, and Dyneema. The redirection microcatheter according to claim 1.

14. The at least one holder is a ring. The redirection microcatheter according to claim 1.

15. The at least one holder is made from one or more of the following: stainless steel, nitinol, cobalt-chromium, nylon, PEEK, platinum-iridium, and gold. The redirection microcatheter according to claim 1.

16. The tubular body is sized and shaped to allow insertion of at least one guide wire into the tubular body. The redirection microcatheter according to claim 1.

17. The device is configured to receive the tubular body and further comprises at least one handle located proximal within the redirection microcatheter. The redirection microcatheter according to claim 1.

18. The system further comprises at least one marking configured to indicate the direction in which one or more side openings are facing. The redirection microcatheter according to claim 1.

19. The at least one of the markings is a radiopaque marking. The redirection microcatheter according to claim 18.

20. The at least one marking is located on the surface of the tubular body, adjacent to one or more side openings, on the at least one actuator, and on the at least one holder. The redirection microcatheter according to claim 18.

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