WO2025058646A1

WO2025058646A1 - Endovascular recanalization systems and methods for utilizing the same

Info

Publication number: WO2025058646A1
Application number: PCT/US2023/074232
Authority: WO
Inventors: John O'shea; Michael Whelan; Jakob WELLS
Original assignee: Bard Peripheral Vascular Inc
Current assignee: Bard Peripheral Vascular Inc
Priority date: 2023-09-14
Filing date: 2023-09-14
Publication date: 2025-03-20
Anticipated expiration: 2026-03-14

Abstract

In one embodiment, an endovascular recanalization system comprises a first catheter comprising a first catheter body and a retractable needle, wherein the retractable needle is configured to extend from a first position within the first catheter body to a second position protruding from a distal portion of the first catheter body further than in the first position; and a second catheter comprising a second catheter body defining a receiving recess for receiving the retractable needle of the first catheter.

Description

ENDOVASCULAR RECANALIZATION SYSTEMS AND METHODS FOR UTILIZING THE SAME

TECHNICAL FIELD

[0001] The present disclosure relates to systems and methods for endovascular treatment, and more particularly for systems and methods for endovascular recanalization utilizing at least one catheter with a retractable needle.

BACKGROUND

[0002] Endovascular treatments of a blood vessel may include endovascular recanalization. Endovascular recanalization typically involves the removal of an occlusion or blockage within a blood vessel, thereby at least partially restoring blood flow through the same. Endovascular recanalization may also occur as a precursor to other revascularization treatments, such as angioplasty. Endovascular recanalization may be a preferred method of treatment over other invasive forms of surgery or treatment.

[0003] However, one challenging aspect of endovascular recanalization is removing complete occlusions, particularly in the form of hard plaques. Such occlusions may be very difficult to remove through traditional procedures.

SUMMARY

[0004] Accordingly, new methods of endovascular recanalization are continually desired. Embodiments of the present disclosure are directed to systems and methods for endovascular recanalization that provide for improved recanalization.

[0005] In one embodiment, an endovascular recanalization system comprises a first catheter comprising a first catheter body and a retractable needle, wherein the retractable needle is configured to extend from a first position within the first catheter body to a second position protruding from a distal portion of the first catheter body further than in the first position; and a second catheter comprising a second catheter body defining a receiving recess for receiving the retractable needle of the first catheter.

[0006] In another embodiment, an endovascular recanalization system comprises a first catheter comprising a first catheter body and a retractable needle, wherein the retractable needle is configured to be advanced from a first position within the catheter body to a second position protruding from a distal portion of the first catheter body further than in the first position; and a second catheter comprising a second catheter body, wherein the first catheter and the second catheter are configured to be arranged opposite one another across an occlusion.

[0007] In yet another embodiment, a method of endovascular recanalization comprises advancing a first catheter through a vessel to an occlusion in a first direction, the first catheter comprising a first catheter body and a retractable needle, wherein the retractable needle is configured to extend from a first position within the catheter body to a second position protruding from a distal portion of the first catheter body further than in the first position; advancing a second catheter through the vessel to the occlusion in a second direction opposite the first direction, the second catheter comprising a second catheter body defining a receiving recess for receiving the retractable needle of the first catheter; alternatively advancing and retreating the first catheter from the occlusion to break up the occlusion; and at least partially seating the retractable needle of the first catheter within the receiving recess of the second catheter.

[0008] These and additional features provided by the embodiments described herein will be more fully understood in view of the following detailed description, in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The embodiments set forth in the drawings are illustrative and exemplary in nature and not intended to limit the subject matter defined by the claims. The following detailed description of the illustrative embodiments can be understood when read in conjunction with the following drawings, where like structure is indicated with like reference numerals and in which:

[0010] FIG. 1 schematically illustrates an endovascular recanalization system, associated power source, and controller, according to one or more embodiments shown and described herein;

[0011] FIG. 2A schematically illustrates a catheter in a first position contained at least partially within the catheter body along with an associated handle having one or more user input devices for controlling a retractable needle, according to one or more embodiments shown and described herein; [0012] FIG. 2B schematically illustrates the catheter of FIG. 2A in a second position protruding from the catheter body, according to one or more embodiments shown and described herein;

[0013] FIG. 3A schematically illustrates a wedge-type retractable needle, according to one or more embodiments shown and described herein;

[0014] FIG. 3B schematically illustrates a pyramidal -type retractable needle, according to one or more embodiments shown and described herein;

[0015] FIG. 3C schematically illustrates a cone-type retractable needle, according to one or more embodiments shown and described herein;

[0016] FIG. 4A schematically illustrates a second catheter with a receiving recess having a first depth along with an associated handle having one or more user input devices for controlling an adjustable terminating surface, according to one or more embodiments shown and described herein;

[0017] FIG. 4B schematically illustrates the second catheter of FIG. 4A having a second receiving depth, according to one or more embodiments shown and described herein;

[0018] FIG. 5 schematically illustrates a side view of a catheter, according to one or more embodiments shown and described herein, with a centralizer on the catheter body;

[0019] FIG. 6 illustrates a flow chart depicting a method for endovascular recanalization, according to one or more embodiments shown and described herein.

[0020] FIG. 7A schematically illustrates a first catheter of the system of FIG. 1 being advanced through a blood vessel toward an occlusion and a second catheter of the system of FIG. 1 being advanced through the same blood vessel from an opposite direction toward the occlusion, according to one or more embodiments shown and described herein;

[0021] FIG. 7B schematically illustrates advancing at least the retractable needle of the first catheter of FIG. 7A through at least a portion of the occlusion, according to one or more embodiments shown and described herein; and [0022] FIG. 7C schematically illustrates the retractable needle of the first catheter of FIGS. 7A and 7B seated within a receiving recess of the second catheter of FIGS. 7A and 7B after breaking through the occlusion, according to one or more embodiments shown and described herein.

[0023] Reference will now be made in greater detail to various embodiments of the present disclosure, some embodiments of which are illustrated in the accompanying drawings. Whenever possible, the same reference numerals will be used throughout the drawings to refer to the same or similar parts.

DETAILED DESCRIPTION

[0024] Embodiments described herein are directed to systems and methods for endovascular treatment of a blood vessel such as, but not limited to endovascular recanalization. For example and as described in embodiments herein, a first catheter may include a retractable needle which may be selectively advanced and retracted to impact an occlusion. Moreover, by being able to retract the retractable needle, the needle may be fully or partially housed within a catheter body of the catheter to assist in preventing unwanted vessel wall contact such as during placement of the catheter at a target location in the vessel, thereby preventing scratching or piercing of the vessel wall by the retractable needle. A second catheter may also be provided defining a receiving recess for receiving the retractable needle of the first catheter during the recanalization procedure. Accordingly, during a recanalization procedure, the retractable needle may cyclically impact with the occlusion to break up or make a passage through the occlusion. The second catheter may act to catch the retractable needle as the retractable needle makes its way through the occlusion to prevent the retractable needle from inadvertently contacting the vessel wall. Accordingly, embodiments provide for improved recanalization or occlusion removal procedures. These and additional features and benefits will be described in greater detail herein.

[0025] As used herein, the term “proximal” means closer to or in the direction of an origin of an element, such as a catheter. The origin of a catheter may be a handle or other user-manipulated portion of the catheter. The term “distal” means further from the origin, or handle, of the catheter. Put another way, the term “distal” means closer to or in the direction of a tip of a catheter, which is separated from a handle or other user-manipulated portion of the catheter by the length of the catheter body. [0026] Referring now to FIG. 1, a system 10 for providing endovascular treatment of a vessel, such as endovascular recanalization, is schematically depicted. The system 10 may include a first catheter 100 and a second catheter 100’ which may interact with one another to perform an endovascular recanalization procedure, for example. It is noted that the first catheter 100 and the second catheter 100’ may be provided within a kit and/or separately from one another.

[0027] Referring now to FIGS. 1-2B, the first catheter 100 may include a first catheter body 102 extending between a distal portion 106 and a proximal portion 108 and a retractable needle 104. It is noted that the first catheter 100 may include a greater or fewer number of components without departing from the scope of the present disclosure. The retractable needle 104 may be configured to extend from a first position “pl” within the first catheter body 102 to a second position “p2” protruding from the distal portion 106 of the first catheter body 102 further than in the first position. In other words, a second distance “d2” the retractable needle 104 protrudes from the first catheter body 102 in the second position p2 is greater than a first distance “dl” the retractable needle 104 protrudes from the first catheter body 102 in the first position pl.

[0028] The first catheter body 102 may be sized to be advanced through a vessel, such as a blood vessel. For example, at least the distal portion 106 may be shaped and/or sized to aid in advancement of the first catheter 100 through a blood vessel. The first catheter body 102 may have any cross-sectional shape and any diameter suitable for intravascular use. The first catheter body 102 may be formed of any material or combination of materials able to be traversed through a vasculature of a body. For example, the first catheter body 102 may include, silicone, rubber, thermoplastic polymers, etc. The first catheter body 102 may be formed through any material generation process, including but not limited to injection molding, extrusion, or other machining processes. The first catheter body 102 may also be reinforced, such as with a stainless steel braiding to prevent buckling of the first catheter body 102 during operation.

[0029] Without being limited by theory, and as explained in further detail hereinbelow, the retractable needle 104 being adjustable (e.g., retractable/advanceable from the first catheter body 102) may allow the retractable needle 104 to be sheathed (such as fully or partially) within the first catheter body 102 while the first catheter 100 is inserted into a blood vessel and maneuvered to a desired location within the blood vessel. This may limit the chance of the retractable needle 104 damaging or inadvertently contacting the blood vessel wall during advancement. Additionally, the retractable needle 104 being adjustable may permit de-lodging of the first catheter 100 from an occlusion while the system 10 is in operation, such as if the first catheter 100 becomes stuck within at least a portion of the occlusion during routine operation, as explained in further detail hereinbelow.

[0030] In embodiments, the first catheter 100 may further include a first push/pull rod 130 positioned within a first internal passageway 107 defined within the first catheter body 102. The first push/pull rod 130 may be coupled to the retractable needle 104 (e.g., via welding, fastening, soldering, adhesive bonding, or through any suitable coupling technique), and may be operable to advance the retractable needle 104 from the first position to the second position, or retract the retractable needle 104 from the first position to the second position, as explained in further detail herein.

[0031] Referring specifically to FIGS. 2A-2B, the first catheter 100 may also include a first handle 136 for operation of the first catheter 100. The first handle 136 may include a first user input device 129 (also referred to as a first sliding limit assembly). The first user input device 129 may control advancement and/or retraction of the retractable needle 104. For example, the first user input device 129 may be a slider, button, switch, or the like, operatively coupled to the retractable needle 104 such that operation of the first user input device 129 controls the position of the retractable needle 104 between a retracted position and an extended position. In embodiments, the first user input device 129 may be coupled to the first push/pull rod 130 extending through the first internal passageway 107 to the retractable needle 104.

[0032] For example, and as depicted in FIGS. 2A and 2B, the first user input device 129 may include a first slider 132 and a first plurality of catches 134 arranged along a first slot 135, the first plurality of catches 134 and the first slot 135 of which may be formed within a body of the first handle 136. In embodiments, the first slider 132 may be coupled to the first push/pull rod 130 and may be positioned along the first slot 135 within one of the first plurality of catches 134. In this manner, adjustment of the first slider 132 along the first slot 135 and the first plurality of catches 134 may operate to translate the linear motion of the first slider 132 into movement of the first push/pull rod 130 and thereby the retractable needle 104 in a controlled manner, as illustrated in FIG. 2A as compared to FIG. 2B. The first plurality of catches 134 may have a first distal catch 134D and a first proximal catch 134P, which may define a maximum and minimum distance upon which the first slider 132, and thereby the retractable needle 104, may be adjusted. In embodiments, there may be any number of intermediate catches 134 between the first distal catch 134D and the first proximal catch 134P such as none, one or more, two or more, three or more, etc.

[0033] Alternatively or additionally to the embodiments above, the first push/pull rod 130 may have a radial diameter r2 that may be greater than the radial diameter rl of the first internal passageway 107 within a distal portion 106 of the first internal passageway 107, such as at first catheter opening 107a. That is, the radial diameter of the first internal passageway 107 may decrease to a diameter that is less than the radial diameter r2 of the first push/pull rod 130, thereby interfering with or otherwise preventing extension of the first push/pull rod 130 through the first catheter opening 107a, as well as limiting the extension distance of the retractable needle 104 from the first catheter body 102. Accordingly, and as illustrated in FIGS. 2A-2B, the maximum distance the retractable needle 104 may extend from the first catheter body 102 may be limited by the radial diameter r2 of the first push/pull rod 130 and/or the position of the first distal catch 134D with respect to the first proximal catch 134P.

[0034] As previously described, the first user input device 129 may be operated by a user to retract the retractable needle 104 so as to wholly or partially sheath the retractable needle 104 within the first catheter body 102 while the first catheter 100 is inserted into a vessel, which may protect the vessel from inadvertent contact with the retractable needle 104 while advancing the first catheter 100 to a target location. Further, the variable adjustment of the first push/pull rod 130 may operate to permit the retractable needle 104 to be dislodged from an occlusion should the same became stuck during routine operation, as described in further detail hereinbelow.

[0035] Still referring to FIGS. 1-2B, the first catheter 100 may further include a first electromagnet 110, which may be positioned on or within the distal portion 106 of the first catheter 100. The first electromagnet 110 may include one or more electromagnetic coils wrapped around a longitudinal axis of the first catheter 100, such as the first catheter body 102. As will be described in greater detail below, using the first electromagnet 110, the first catheter 100 may be cyclically advanced and impacted against an occlusion to break up an occlusion such as in a recanalization procedure. Accordingly, the first electromagnet 110 may be electrically coupled to a power source 112 (e.g., a battery, outlet, etc.) which delivers current to electromagnetic to produce the cyclic impacting motion. The first electromagnet 110 may be electrically coupled to the power source 112 via wiring which may be routed through the first internal passageway 107 of the first catheter body 102. In embodiments, the power source 112 may be mounted to or included within the first handle 136 or may be separate therefrom.

[0036] Now referring to FIGS. 3A-3C, the retractable needle 104 may comprise a variety of shapes, including, but not limited to, wedge-shaped (FIG. 3 A), pyramidal-shaped (FIG. 3B), cone- shaped (FIG. 3C), or any other shape. In embodiments, the retractable needle 104 have a pointed distal tip 104a as depicted. However, in other embodiments, the distal tip may be blunt. The retractable needle 104 may be formed of any suitable material for insertion within a vessel and/or impacting a vessel occlusion. For example, the retractable needle 104 may a metal or metal alloy, such as or including tungsten, tungsten carbide, steel, stainless steel, etc. In embodiments, during a recanalization procedure, the retractable needle 104 may be advanced to an extended position and impacted against an occlusion as will be described in greater detail below. In some embodiments, it is contemplated that the retractable needle may itself be electromagnetic. In such embodiments, one or more hardness coatings may be applied to the retractable needle to resist corrosion and/or damage due to impact.

[0037] Now referring to FIGS. 1, 4A, and 4B, the second catheter 100’ may have similar features to the first catheter 100 and/or may include features which interact with the first catheter 100 to assist in occlusion crossing/recanalization. In particular, the second catheter 100’ of the present embodiment generally includes a second catheter body 102’ extending between a distal portion 106’ and a proximal portion 108’. As illustrated in FIGS. 1, 4A, and 4B, the second catheter body 102’ may define a receiving recess 105’ for receiving the retractable needle 104 of the first catheter 100, as will be described in greater detail herein. It is noted that the second catheter 100’ may also comprise a greater or fewer number of components without departing from the scope of the present disclosure.

[0038] Similar to the first catheter 100, the second catheter body 102’ may be sized to be advanced through a vessel. For example, at least the distal portion 106’ may be shaped and/or sized to aid in advancement of the second catheter 100’ through a blood vessel. The second catheter body 102’ may have any cross-sectional shape and any diameter suitable for intravascular use. The second catheter body 102’ may be formed of any material or combination of materials able to be traversed through a vasculature of a body. For example, the second catheter body 102’ may include, silicone, rubber, a thermoplastic polymer etc. The second catheter body 102’ may be formed through any material generation process, including but not limited to injection molding, extrusion, or other machining process. The second catheter body 102’ may also be reinforced, such as with a stainless steel braiding, to prevent buckling of the second catheter body 102’ during operation.

[0039] As noted above, the second catheter body 102’ may define a receiving recess 105’. The receiving recess 105’ may be sized and shaped to receive the retractable needle 104 of the first catheter 100, such that the first catheter 100 may seat within the second catheter 100’ during a recanalization procedure as described in further detail below. For example, and as illustrated in FIG. 1, the receiving recess 105’ may be partially/ fully conical or rounded, such as frusto-conical, frusto-spherical, frusto-elliptical, or combinations thereof, which may allow for guiding of the retractable needle 104 of the first catheter 100 into the receiving recess 105’ to aid seating of the first catheter 100 into the second catheter 100’. The second catheter 100’ may also further include or define a terminating surface 120’ defining a depth of the receiving recess 105’. The terminating surface 120’ may be formed of a similar or different material than the second catheter body 102’. For example, and in embodiments, the terminating surface 120’ may be formed of a pebax or rubber material with a sufficient modulus of elasticity to dissipate the force generated by the seating of the retractable needle into the receiving recess, and doing so without damaging the end of the retractable needle, puncturing the terminating surface 120’, or both. To aid in preventing damage to the end of the retractable, preventing puncturing of the terminating surface 120’, or both, the retractable needle may also be blunt, as previously described. In embodiments, the position of the terminating surface 120’ may be adjustable.

[0040] For example, and with reference specifically to FIGS. 4A-4B, the second catheter 100’ is illustrated with an adjustable terminating surface 120’. The receiving recess 105’ has a depth defined from a second catheter opening 114’ of the receiving recess 105 ’ to the terminating surface 120’. The terminating surface 120’ may be configured to advance, i.e. be adjustable, from a first position “Pl” with a first depth “DI” to a second position “P2” with a second depth “D2”, wherein the second depth D2 at the second position P2 is less than the first depth DI at the first position Pl. Without being limited by theory, and as explained in further detail hereinbelow, the terminating surface 120’ being adjustable may allow de-lodging of the second catheter 100’ from an occlusion while the system 10 is in operation, such as if the second catheter 100’ becomes stuck within at least a portion of the occlusion during routine operation. [0041] To assist in adjusting a position of the terminating surface 120’, the second catheter 100’ may further include a second push/pull rod 130’ positioned within a second internal passageway 107’ defined within the second catheter body 102’. The second push/pull rod 130’ may be coupled to the terminating surface 120’ of the receiving recess 105’ (e.g., via welding, fastening, soldering, adhesive bonding, or through any suitable coupling technique), and may be operable to transition the terminating surface 120’ from the first position to the second position, and vice versa, as explained in further detail herein. As illustrated in FIGS. 4A and 4B, the terminating surface 120’ may also define a cavity 115’, which may be radially centered on the terminating surface 120’. The cavity 115’ may be shaped to receive the tip of the retractable needle 104. In other words, the cavity 115’ may be rounded, semi-spherical, pyramidal, or any frusto- varations of the previous. For example, the cavity 115’ may be sized to receive the tip, while limiting insertion depth of the retractable needle 104 by engaging a side wall of the tip.

[0042] Still referring to FIGS. 1, 4A, and 4B, the second catheter 100’ may also include a second handle 136’ for operation of the second catheter 100’, which may be similar or identical to the first handle 136. The second handle 136’ may include a second user input device 129’ (also referred to as a second sliding limit assembly). The second user input device 129’ may control advancement/retraction of the terminating surface 120’. For example, the second user input device 129’ may be a slider, button, switch, or the like, operatively coupled to the terminating surface 120’ such that operation of the second user input device 129’ controls the position of the terminating surface 120’ between the first position and the second position. For example, in embodiments, the second user input device 129’ may be coupled to the second push/pull rod 130’ extending through the second internal passageway 107’ to the terminating surface 120’.

[0043] For example, and as depicted in FIGS. 4A and 4B, the second user input device 129’ may include a second slider 132’ and a second plurality of catches 134’ arranged along a second slot 135’, the second slot 135’ and the second plurality of catches 134’ of which may be formed within a body of the second handle 136’. In embodiments, the second slider 132’ may be coupled to the second push/pull rod 130’ and may be positioned along the second plurality of catches 134’. In this manner, adjustment of the second slider 132’ along the second slot 135’ within one of the second plurality of catches 134’ may operate to translate the linear motion of the second slider 132’ into movement of the second push/pull rod 130’ and thereby the terminating surface 120’ in a controlled manner, as illustrated in FIG. 4A as compared to FIG. 4B. The second plurality of catches 134’ may also have a second distal catch 134D’ and a second proximal catch 134P’, which may define a maximum and minimum distance upon which the second slider 132’, and thereby the terminating surface 120’, may be adjusted. In embodiments, there may be any number of intermediate catches 134 between the second distal catch 134D’ and the second proximal catch 134P’, such as none, one or more, two or more, three or more, etc. As noted above, the variable adjustment of the second push/pull rod 130’ and terminating surface 120’ may operate to permit occlusive material to be removed from the receiving recess 105’ or the second catheter 100’ to be dislodged from an occlusion should the same became stuck during routine operation, as described in further detail hereinbelow.

[0044] Still referring to FIGS. 1, 4A, and 4B, the second catheter 100’ may further include a second electromagnet 110’, which may be positioned on or within the distal portion 106’ of the second catheter 100’. In some embodiments, the second electromagnet 110’ may be positioned proximal the receiving recess 105’. The second electromagnet 110’ may be similar in some or all aspects to the first electromagnet 110 for the first catheter 100. For example, and in embodiments, the second electromagnet 110’ may include one or more electromagnetic coils wrapped around a longitudinal axis of the second catheter 100’, such as the second catheter body 102’. As will be described in greater detail below, using the second electromagnet 110’, the second catheter 100’ may be cyclically advanced and impacted against an occlusion to break up an occlusion such as in a recanalization procedure. The second electromagnet 110’ may be electrically coupled to a power source 112, via wiring which may be routed through an internal passageway of the second catheter body 102’. The power source 112 may be the same or different power source 112 that is electrically coupled to the first catheter 100, which delivers current to the second electromagnet 110’ to produce the cyclic impacting motion. As above, the power source 112 may be mounted to or included within the second handle 136’ or may be separate therefrom, such as where the first catheter 100 and the second catheter 100’ share the same power source 112.

[0045] In embodiments, the system 10 may include a controller 113 which may be communicatively coupled to the power source 112 (or power sources) and may be operable to execute logic to cause the power source 112 to deliver current to the first electromagnet 110 and/or the second electromagnet 110’ to generate magnetic fields sufficient to cause the cyclic impacting motion, as will be described in greater detail below. The controller 113 may be any type of computing device such as, but not limited to, control circuits, chipsets, laptop computers, desktop computers, tablets, etc. In embodiments, the controller 113 may be a console separate from the first handle 136 and the second handle 136’ and may be coupled to each via wiring, wireless communication, or the like. In other embodiments, the controller 113 may include multiple control elements distributed within the first handle 136, the second handle 136’ and/or a console. The logic executed by the controller 113 may be stored on one or more memories communicatively coupled to the controller 113. The one or more memories may include a storage device such as, but not limited to, a remote server.

[0046] Executing the logic, the controller 113 may control delivery of current to the first and second electromagnets 100/100’ to alter polarity of the first and/or second electromagnets 100/100’ to cyclically cause retraction/repulsion between the first electromagnet 110 and the second electromagnet 110’, thereby drawing the first catheter 100 and the second catheter 100’ toward and away from one another. Further, the cyclical retraction/repulsion may also create a jackhammer-like effect on an occlusion positioned between the first catheter 100 and the second catheter 100’. That is, the first and second electromagnets 110/110’ on or within the distal portion 106 of the first and second catheters 100/100’, respectively, may be operated to magnetically guide first and second catheters 100/100’ toward and away from each other while in operation. This guidance may further reduce the risk of the retractable needle 104 puncturing or inadvertently contacting the walls of the blood vessel during operation as it will be guided into the receiving recess 105’.

[0047] The alternating magnetic polarity may have a frequency of from greater than or equal to 1 Hz to less than or equal to 150 Hz, such as from 1 Hz to 2 Hz, from 2 Hz to 10 Hz, from 10 Hz to 20 Hz, from 20 Hz to 50 Hz, from 50 Hz to 80 Hz, from 80 Hz to 100 Hz, from 100 Hz to 120 Hz, from 120 Hz to 150 Hz, or any combination of the preceding ranges or smaller ranger therein, such as from 2 Hz to 20 Hz. Similarly, the first electromagnet 110, the second electromagnet 110’, or both may have an electromagnetic intensity of from 50,000 Gauss to 100,000 Gauss when supplied with power from the power source 112, such as from 50,000 Gauss to 60,000 Gauss, from 60,000 Gauss to 70,000 Gauss, from 70,000 Gauss to 80,000 Gauss, from 80,000 Gauss to 90,000 Gauss, from 90,000 Gauss to 100,000 Gauss, or any combination of the preceding ranges or smaller range therein, such as from 60,000 Gauss to 90,000 Gauss. Without being limited by theory, the electromagnetic intensity of the electromagnets may vary depending on a number of factors, including but not limited to the amperage supplied to the electromagnets, the size of the electromagnets, and the size of the intravascular lesion or occlusion. Accordingly, assumed in the electromagnetic intensity previously stated is a greater than 1 amp to less than or equal to 5 amp current to the electromagnets for an approximately 5 centimeter intravascular lesion or occlusion.

[0048] In some embodiments, it is contemplated that the power source 112 may be configured to maintain a magnetic polarity in the first catheter 100 or second electromagnet 110’, and generate an alternating magnetic polarity in the other of the first electromagnet 110 of the second catheter 100’, such as through the controller 113.

[0049] In some embodiments, it is contemplated that the controller 113 may be communicatively coupled to the first user input device 129, the second user input device 129’, or both. For example, the first user input device 129, the second user input device 129’, or both may include an actuator (e.g., linear actuator, motor, etc.) which may be used to adjust the positioning of the retractable needle 104 and/or the terminating surface 120’. In embodiments, based on a user input to the controller 113 (e.g., such as via a button, touch screen joystick, etc.) the controller 113 may operate to adjust the position of the retractable needle 104 and/or the terminating surface 120’.

[0050] Now referring to FIG. 5, the first catheter body 102, the second catheter body 102’, or both may include a centralizer 116 disposed on an external surface of the first and catheter bodies 102/102’, respectively. The centralizer 116 may include one or more centralizer blades 118 and one or more one or more channels 117 extending between each centralizer blade 118 along the length of the centralizer 116. Without being limited by theory, the one or more centralizer blades 118 may operate to center the first catheter 100 within the blood vessel by engaging at least a portion of the sidewall of the blood vessel to generally assist in maintaining axial alignment of the first catheter 100, the second catheter 100’, or both, within the blood vessel. Further, the one or more channels 117 may allow blood flow along the centralizer 116 and by the one or more centralizer blades 118, thereby assisting in prevention of further occlusions. The one or more centralizer blades 118 may extend parallel along the length of the centralizer 116 or the one or more centralizer blades 118 may extend along the length of the centralizer 116 in a helical manner, as illustrated. Alternatively, the centralizer may take on other forms, such as a balloon, which may be inflated. For example, the balloon may be inflated sufficiently to provide centralization forces but not gripping forces against the vessel walls.

[0051] Still referring to FIG. 5, it is noted that the first catheter 100 and/or the second catheter 100’ and any accompanying elements may be sized and/or shaped to be advanced through any target vessel or blood vessel. For example, in blood vessels having an internal diameter of about 3 mm, it may be desirable to configure any of the catheter elements to be less than about 3 mm in diameter/width. In some embodiments, the first catheter 100 and/or the second catheter 100’ may have any suitable diameter for intravascular use, such as, for example, about 4 French (1.33 mm), about 5.7 French (1.9 mm), about 6.1 French (2.03 mm), about 7 French (2.33 mm), about 8.3 French (2.77 mm), or a value between about 4 French (1.33 mm) and about 9 French (3.0 mm), between about 4 French (1.33 mm) and about 7 French (2.33 mm), between about 4 French (1.33 mm) and about 6 French (2.0 mm), or the like.

[0052] Referring now to FIG. 6, a flow chart illustrating a method 600 of endovascular recanalization is generally illustrated, such as by utilizing the system 10 as previously described. It is noted that the method 600 may include a greater or fewer number of steps, taken in any order, without departing from the scope of the present disclosure. It is noted that the method 600 illustrated in FIG. 6, may be best understood when reviewed in conjunction with FIGS. 7A-7C, which generally illustrate insertion and recanalization of a blood vessel utilizing the first catheter 100 and the second catheter 100’ as described herein.

[0053] Still referring to FIGS. 6-7C, at block 602 the method 600 includes advancing the first catheter 100 through a vessel 180 to an occlusion 182 in a first direction 184. The first catheter 100 may be advanced through the vessel 180 while the retractable needle 104 is in the first position. Once the first catheter 100 is positioned as desired relative to the occlusion 182, the retractable needle 104 may be extended to the second position, such as via the first user input device 129. As previously described, by waiting to extend the retractable needle 104 to the second position until positioned as described within the vessel 180, inadvertent contact of the needle tip with the vessel wall may be limited or avoided during traversal of the first catheter 100 to the occlusion 182.

[0054] At block 604, the method 600 includes advancing the second catheter 100’ through the vessel 180 to the occlusion 182 in a second direction 186, wherein the second direction 186 may be opposite the first direction 184. In other words, the second catheter 100’ may be positioned opposite the first catheter 100 across the occlusion 182 in the vessel 180.

[0055] Now referring to FIG. 6 and FIG. 7B, at block 606 the method 600 may include alternatively or cyclically advancing and retreating at least one of the first catheter 100 and the second catheter 100’ to and from the occlusion 182 to break up or cross the occlusion 182. In embodiments, the retractable needle 104 is positioned within the second, advanced position during impaction of the occlusion 182 to assist in breaking up and/or crossing the occlusion 182. As noted above, the first catheter 100 and the second catheter 100’ may include the first electromagnet 110 and the second electromagnet 110’, respectively, which may both be electrically coupled to the power source 112, or two separate power sources. The controller 113 may operate the power source 112 (or power sources) to adjust magnetic polarities of the first electromagnet 110 and/or the second electromagnet 110’ to have them be cyclically repelled or attracted to one another, thereby impacting the occlusion 182 from either side and creating a jackhammer-like effect. That is, the power source 112 may alternate the magnetic polarities between the first and second electromagnets 110/110’ to create repulsive and attractive forces, causing the first and second catheters 100/110’ to repeatedly impact the occlusion 182. Accordingly, as the retractable needle 104 is impacted against the occlusion 182, the retractable needle 104 may penetrate, break up, or otherwise create a pathway through the occlusion 182. Similarly, the second catheter 100’ may impact the opposite side of the occlusion 182, which may assist in breaking up the occlusion 182 in a similar manner. Accordingly, a jackhammer-like effect is made on the occlusion 182 via operation of the first catheter 100 and/or the second catheter 100’.

[0056] Still referring to FIGS. 6-7B, at block 608 the method 600 may include an observation step, wherein, while alternating the magnetic polarity, the first catheter 100 is observed to confirm that movement to and from the occlusion 182 by the retractable needle 104 is occurring. Without being limited by theory, if such movement is not observed while alternating the magnetic polarity, it may indicate that the retractable needle 104 is stuck within at least a portion of the occlusion 182. Such observation means may occur through fluoroscopy, although any other means commonly used to observe endovascular operations are contemplated without departing from the scope of the present disclosure. If a lack of movement away from the occlusion 182 by the retractable needle 104 is observed, the method 600 may progress to block 610, which includes retracting the retractable needle 104 to the first position, which may dislodge the retractable needle 104 from the occlusion 182. In some embodiments, the method 600 may further include, at block 612, modifying the magnetic polarity to a magnetic repulsion between the first electromagnet 110 and the second electromagnet 110’ to assist in dislodging the retractable needle 104 from the occlusion 182 with or without first retracting the retractable needle 104 to the first position.

[0057] In some embodiments, at block 614, once dislodged, the retractable needle 104 may be advanced back to the second position, with cyclic impacting of the occlusion 182 resuming at block 606. In embodiments, periodically extending and retracting the retractable needle 104 may operate to push out occlusive material (not illustrated) that may be jammed in the first internal passageway 107, clearing occlusive material potentially built up during the method 600.

[0058] Still referring to FIGS. 6-7B, the method 600 may include at block 616 similarly observing the second catheter 100’ to confirm that movement to and from the occlusion 182 by the second catheter 100’ is occurring. Similar to block 608, if a lack of movement away from the occlusion 182 by the second catheter 100’ is observed while alternating the magnetic polarity, the method 600 may progress to block 618, which may include advancing the terminating surface 120’ of the receiving recess 105’ to the second position, which may push out occlusive material that may be stuck within the receiving recess 105’ and free the second catheter 100’. In some embodiments, the method 600 may include, at block 612, modifying the magnetic polarity to a magnetic repulsion between the first electromagnet 110 and the second electromagnet 110’ to assist in dislodging the second catheter 100’ from the occlusion 182 with or without the terminating surface 120’ having been advanced to the second position. It is further noted that periodically advancing the terminating surface 120’ from the first position to the second position may assist in periodically clearing the receiving recess 105 ’ to thereby prevent the second catheter 100’ from becoming stuck or bogged down with occlusive material. Furthermore, and in embodiments, advancing the terminating surface 120’ may clear occlusive material potentially built up during the method 600 and aid in seating of the first catheter 100 into the second catheter 100’, described below. Once free or cleared, the terminating surface 120’ may be returned to the first position. After freeing the first catheter 100, the second catheter 100’ or both, resuming cyclically impacting the occlusion 182 may occur, such as at block 606 of the method 600.

[0059] Now referring to FIGS. 6-7C, assuming continued movement of the first and/or second catheter 100/100’, the method 600 may further include cyclically impacting the occlusion 182 until the first catheter 100 becomes seated in the second catheter 100’. For example, the method 600 may continue with cyclic impaction of the occlusion 182 until the retractable needle 104 is seated within the receiving recess 105’. Such seating may be determined via user observation for example. Without being limited by theory, observation of the first catheter 100 seating into the second catheter 100’ may be visually observed through fluoroscopy, or it may be observed through a light jarring feedback to the user differentiable from vibration attributable to the alternating of the magnetic polarity. In some embodiments, upon seating of the first catheter 100 into the second catheter 100’, the magnetic polarity may be modified to repulsion, upon which the first catheter 100 and the second catheter 100’ may be withdrawn from the vessel 180. [0060] Embodiments can be described with reference to the following numerical clause:

[0061] 1. An endovascular recanalization system comprising a first catheter comprising a first catheter body and a retractable needle, wherein the retractable needle is configured to extend from a first position within the first catheter body to a second position protruding from a distal portion of the first catheter body further than in the first position; and a second catheter comprising a second catheter body defining a receiving recess for receiving the retractable needle of the first catheter.

[0062] 2. The system of clause 1, further comprising a power source, wherein: the first catheter comprises a first electromagnet positioned on or within the distal portion of the first catheter; the second catheter comprises a second electromagnet positioned proximal the receiving recess; and the power source is electrically coupled to the first and second electromagnets and is configured to generate an alternating magnetic polarity between the first and second electromagnets.

[0063] 3. The system of clause 2, wherein the alternating magnetic polarity comprises a frequency of from 50 Hz to 150 Hz.

[0064] 4. The system of clause 2 or 3, wherein the first electromagnet, the second electromagnet, or both have an electromagnetic intensity of from 50,000 Gauss to 100,000 Gauss.

[0065] 5. The system of any preceding clause, wherein the first catheter, the second catheter, or both further comprise a centralizer disposed on an external surface of the first catheter body, the second catheter body, or both, respectively.

[0066] 6. The system of any preceding clause, wherein: the receiving recess has a depth defined from an opening of the receiving recess to a terminating surface of the receiving recess; the terminating surface of the receiving recess is configured to advance from a first position to a second position, wherein the depth at the second position is less than the depth at the first position.

[0067] 7. The system of clause 6, wherein: the terminating surface of the receiving recess is configured to advance from the first position to the second position through a second sliding limit assembly; the second sliding limit assembly comprises a second plurality of catches, a second slider configured to be advanced through the second plurality of catches, and a second push/pull rod coupled to the second slider and to the terminating surface; and the second push/pull rod is positioned within a second internal passageway defined within the second catheter body.

[0068] 8. The system of any preceding clause, wherein: the retractable needle is configured to extend from the first position to the second position through a first sliding limit assembly; the first sliding limit assembly comprises a first plurality of catches, a first slider configured to be advanced through the first plurality of catches, and a first push/pull rod coupled to the first slider and to the retractable needle; and the first push/pull rod is positioned within a first internal passageway defined within the first catheter body.

[0069] 9. The system of any preceding clause, wherein the retractable needle is wedge- shaped, cone-shaped, or pyramidal-shaped.

[0070] 10. The system of any preceding clause, wherein the retractable needle is formed from tungsten, tungsten carbide, steel, stainless steel, or combinations thereof.

[0071] 11. An endovascular recanalization system comprising: a first catheter comprising a first catheter body and a retractable needle, wherein the retractable needle is configured to be advanced from a first position within the catheter body to a second position protruding from a distal portion of the first catheter body further than in the first position; and a second catheter comprising a second catheter body, wherein the first catheter and the second catheter are configured to be arranged opposite one another across an occlusion.

[0072] 12. The system of clause 11, further comprising a power source, wherein the first catheter comprises a first electromagnet positioned on or within the distal portion of the first catheter; the second catheter comprises a second electromagnet positioned proximal the receiving recess; and the power source is electrically coupled to the first and second electromagnets and is configured to generate an alternating magnetic polarity between the first and second electromagnets.

[0073] 13. The system of either clause 11 or 12, wherein the retractable needle is configured to extend from the first position to the second position through a first sliding limit assembly; the first sliding limit assembly comprises a first plurality of catches, a first slider configured to be advanced through the first plurality of catches, and a first push/pull rod coupled to the first slider and to the retractable needle; and the first push/pull rod is positioned within a first internal passageway defined within the first catheter body. [0074] 14. A method of endovascular recanalization, the method comprising: advancing a first catheter through a vessel to an occlusion in a first direction, the first catheter comprising a first catheter body and a retractable needle, wherein the retractable needle is configured to extend from a first position within the catheter body to a second position protruding from a distal portion of the first catheter body further than in the first position; advancing a second catheter through the vessel to the occlusion in a second direction opposite the first direction, the second catheter comprising a second catheter body defining a receiving recess for receiving the retractable needle of the first catheter; alternatively advancing and retreating the first catheter from the occlusion to break up the occlusion; and at least partially seating the retractable needle of the first catheter within the receiving recess of the second catheter.

[0075] 15. The method of clause 14, wherein: the first catheter further comprises a first electromagnet positioned on or within the distal portion of the first catheter; the second catheter further comprises a second electromagnet positioned proximal the receiving recess; a power source is electrically coupled to the first and second electromagnets; and alternatively advancing and retreating at least the first catheter from the occlusion further comprises alternating a magnetic polarity between the first and second electromagnets utilizing the power source.

[0076] 16. The method of clause 14 or 15, further comprising extending the retractable needle to the second position prior to alternatively advancing and retreating the first catheter, wherein: the retractable needle is configured to be advanced from the first position to the second position through a first sliding limit assembly; the first sliding limit assembly comprises a first plurality of catches, a first slider configured to advance through the first plurality of catches, and a first push/pull rod coupled to the first slider and to the retractable needle; and the first push/pull rod is positioned within a first internal passageway defined within the first catheter body.

[0077] 17. The method of clause 15 or 16, further comprising: observing a lack of movement away from the occlusion by the retractable needle while alternating the magnetic polarity; retracting the retractable needle to the first position; modifying the magnetic polarity to a magnetic repulsion between the first and second electromagnets; extending the retractable needle back to the second position; and resuming alternating the magnetic polarity.

[0078] 18. The method of any of clauses 15-17, further comprising: observing a lack of movement away from the occlusion by the second catheter while alternating the magnetic polarity, the second catheter having a depth defined from an opening of the receiving recess to a terminating surface of the receiving recess; extending the terminating surface from a first position to a second position, wherein a depth at the second position is less than the depth at the first position; modifying the magnetic polarity to a magnetic repulsion between the first and second electromagnets, retracting the terminating surface of the receiving recess to the first position, and resuming alternating the magnetic polarity.

[0079] 19. The method of any of clauses 15-18, further comprising alternatively advancing and retreating at least the retractable needle from the occlusion at a frequency of from greater than or equal to 50 Hz to less than or equal to 150 Hz.

[0080] 20. The method of any of clauses 15-19, further comprising alternatively advancing and retreating at least the retractable needle from the occlusion at an electromagnetic intensity of from 50,000 Gauss to 100,000 Gauss.

[0081] 21. The method of any one of clauses 14-20, further comprising engaging at least a portion of a sidewall of the vessel with a centralizer disposed on an external surface of the first catheter body, the second catheter body, or both.

[0082] 22. The method of any one of clauses 14-21, wherein the retractable needle is wedge- shaped, cone-shaped, or pyramidal-shaped.

[0083] It should now be understood that embodiments described herein are directed to improved systems and methods for endovascular treatment of a blood vessel such as, but not limited to endovascular recanalization. In particular, embodiments of the present disclosure use catheters to cyclically impact an occlusion to cross and/or break up an occlusion. In particular, embodiments utilize magnetic attraction and repulsion to create a jack hammer-like effect on the occlusion for crossing and/or break-up. In some embodiments, retractable and extendable elements (e.g., a retractable needle and/or terminating surface) may be used to periodically free catheters embedded and/or stuck within an occlusion, to allow procedures to continue without interruption.

[0084] It is noted that the terms "substantially" and "about" may be utilized herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. These terms are also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue. [0085] While particular embodiments have been illustrated and described herein, it should be understood that various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. Moreover, although various aspects of the claimed subject matter have been described herein, such aspects need not be utilized in combination. It is therefore intended that the appended claims cover all such changes and modifications that are within the scope of the claimed subject matter.

Claims

1. An endovascular recanalization system comprising: a first catheter comprising a first catheter body and a retractable needle, wherein the retractable needle is configured to extend from a first position within the first catheter body to a second position protruding from a distal portion of the first catheter body further than in the first position; and a second catheter comprising a second catheter body defining a receiving recess for receiving the retractable needle of the first catheter.

2. The system of claim 1, further comprising a power source, wherein: the first catheter comprises a first electromagnet positioned on or within the distal portion of the first catheter; the second catheter comprises a second electromagnet positioned proximal the receiving recess; and the power source is electrically coupled to the first and second electromagnets and is configured to generate an alternating magnetic polarity between the first and second electromagnets.

3. The system of claim 2, wherein the alternating magnetic polarity comprises a frequency of from 50 Hz to 150 Hz.

4. The system of claim 2, wherein the first electromagnet, the second electromagnet, or both have an electromagnetic intensity of from 50,000 Gauss to 100,000 Gauss.

5. The system of claim 1, wherein the first catheter, the second catheter, or both further comprise a centralizer disposed on an external surface of the first catheter body, the second catheter body, or both, respectively.

6. The system of claim 1, wherein: the receiving recess has a depth defined from an opening of the receiving recess to a terminating surface of the receiving recess; the terminating surface of the receiving recess is configured to advance from a first position to a second position, wherein the depth at the second position is less than the depth at the first position.

7. The system of claim 6, wherein: the terminating surface of the receiving recess is configured to advance from the first position to the second position through a second sliding limit assembly; the second sliding limit assembly comprises a second plurality of catches, a second slider configured to be advanced through the second plurality of catches, and a second push/pull rod coupled to the second slider and to the terminating surface; and the second push/pull rod is positioned within a second internal passageway defined within the second catheter body.

8. The system of claim 1, wherein: the retractable needle is configured to extend from the first position to the second position through a first sliding limit assembly; the first sliding limit assembly comprises a first plurality of catches, a first slider configured to be advanced through the first plurality of catches, and a first push/pull rod coupled to the first slider and to the retractable needle; and the first push/pull rod is positioned within a first internal passageway defined within the first catheter body.

9. The system of claim 1, wherein the retractable needle is wedge-shaped, cone-shaped, or pyramidal-shaped.

10. The system of claim 1, wherein the retractable needle is formed from tungsten, tungsten carbide, steel, stainless steel, or combinations thereof.

11. An endovascular recanalization system comprising: a first catheter comprising a first catheter body and a retractable needle, wherein the retractable needle is configured to be advanced from a first position within the catheter body to a second position protruding from a distal portion of the first catheter body further than in the first position; and a second catheter comprising a second catheter body, wherein the first catheter and the second catheter are configured to be arranged opposite one another across an occlusion.

12. The system of claim 11, further comprising a power source, wherein: the first catheter comprises a first electromagnet positioned on or within the distal portion of the first catheter; the second catheter comprises a second electromagnet positioned proximal the receiving recess; and the power source is electrically coupled to the first and second electromagnets and is configured to generate an alternating magnetic polarity between the first and second electromagnets.

13. The system of claim 11, wherein: the retractable needle is configured to extend from the first position to the second position through a first sliding limit assembly; the first sliding limit assembly comprises a first plurality of catches, a first slider configured to be advanced through the first plurality of catches, and a first push/pull rod coupled to the first slider and to the retractable needle; and the first push/pull rod is positioned within a first internal passageway defined within the first catheter body.

14. A method of endovascular recanalization, the method comprising: advancing a first catheter through a vessel to an occlusion in a first direction, the first catheter comprising a first catheter body and a retractable needle, wherein the retractable needle is configured to extend from a first position within the catheter body to a second position protruding from a distal portion of the first catheter body further than in the first position; advancing a second catheter through the vessel to the occlusion in a second direction opposite the first direction, the second catheter comprising a second catheter body defining a receiving recess for receiving the retractable needle of the first catheter; alternatively advancing and retreating the first catheter from the occlusion to break up the occlusion; and at least partially seating the retractable needle of the first catheter within the receiving recess of the second catheter.

15. The method of claim 14, wherein: the first catheter further comprises a first electromagnet positioned on or within the distal portion of the first catheter; the second catheter further comprises a second electromagnet positioned proximal the receiving recess; a power source is electrically coupled to the first and second electromagnets; and alternatively advancing and retreating at least the first catheter from the occlusion further comprises alternating a magnetic polarity between the first and second electromagnets utilizing the power source.

16. The method of claim 14, further comprising extending the retractable needle to the second position prior to alternatively advancing and retreating the first catheter, wherein: the retractable needle is configured to be advanced from the first position to the second position through a first sliding limit assembly; the first sliding limit assembly comprises a first plurality of catches, a first slider configured to advance through the first plurality of catches, and a first push/pull rod coupled to the first slider and to the retractable needle; and the first push/pull rod is positioned within a first internal passageway defined within the first catheter body.

17. The method of claim 15, further comprising: observing a lack of movement away from the occlusion by the retractable needle while alternating the magnetic polarity; retracting the retractable needle to the first position; modifying the magnetic polarity to a magnetic repulsion between the first and second electromagnets; extending the retractable needle back to the second position; and resuming alternating the magnetic polarity.

18. The method of claim 15, further comprising: observing a lack of movement away from the occlusion by the second catheter while alternating the magnetic polarity, the second catheter having a depth defined from an opening of the receiving recess to a terminating surface of the receiving recess; extending the terminating surface from a first position to a second position, wherein a depth at the second position is less than the depth at the first position; modifying the magnetic polarity to a magnetic repulsion between the first and second electromagnets, retracting the terminating surface of the receiving recess to the first position, and resuming alternating the magnetic polarity.

19. The method of claim 15, further comprising alternatively advancing and retreating at least the retractable needle from the occlusion at a frequency of from greater than or equal to 50 Hz to less than or equal to 150 Hz.

20. The method of claim 15, further comprising alternatively advancing and retreating at least the retractable needle from the occlusion at an electromagnetic intensity of from 50,000 Gauss to 100,000 Gauss.

21. The method of claim 14, further comprising engaging at least a portion of a sidewall of the vessel with a centralizer disposed on an external surface of the first catheter body, the second catheter body, or both.

22. The method of claim 14, wherein the retractable needle is wedge-shaped, cone-shaped, or pyramidal-shaped.