Reentry Catheter

Abstract

The delivery system 100 can have the ability to change its configuration to achieve both access to and treatment of a target anatomical structure. Such treatment can include directing an interventional device around an occlusion. By providing different functionality at different stages, the need to swap and exchange tools at different stages can be reduced or eliminated. Thus, such procedures can be completed more quickly, efficiently, and safely.

Description

[Technical field]

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 886,239, entitled “RE-ENTRY CATHETER,” filed August 13, 2019, which is incorporated by reference in its entirety.

[0002] TECHNICAL FIELD This description relates generally to the treatment of stenoses in body vessels, and more particularly to catheters and methods for crossing chronic total occlusions in blood vessels. [Background technology]

[0003] Chronic total occlusions ("CTOs") are vascular lesions characterized by severe atherosclerotic plaques within a blood vessel, resulting in a complete (or near-complete) interruption of blood flow across the lesion. Such occlusions can occur anywhere in a patient's vascular system. Because most lesions occur gradually over a long period of time, ischemic tissue downstream of the lesion has time to develop collateral circulation. For example, in the case of a coronary artery, collateral vessels may arise from a proximal artery and connect to a distal artery ("ipsilateral collaterals"), or collateral vessels may arise from other major arterial branches and connect to a distal artery ("contralateral collaterals"). When the lesion eventually becomes totally occluded, the collateral circulation is usually sufficient to keep the distal tissue alive, albeit is ischemic. It is therefore desirable to reestablish blood flow through or around the obstruction in the blood vessel by crossing the CTO and advancing a therapeutic device, such as a balloon angioplasty catheter, to dilate and treat the CTO. Similarly, in some cases, it may be necessary to cross a CTO to gain access to a location along the vasculature distal to the CTO. CTOs may be more difficult to cross than partially occluded lesions because the guidewire must either penetrate the lesion, rather than through an existing lumen, or circumvent the lesion via the subintimal layer of the vessel wall when penetrating the occlusion would be impractically difficult and / or complicated.

[0004] The description provided in the Background section should not be considered prior art merely because it is mentioned in or associated with the Background section. The Background section may contain information that describes one or more aspects of the present technology. [Brief description of the drawings]

[0005] [Figure 1] FIG. 2 is a side view of a delivery device. [Diagram 2] FIG. 2 is a perspective view of a distal portion of a delivery device. [Diagram 3] FIG. 2 is a top view of a distal portion of a delivery device. [Figure 4] 4 is a cross-sectional view of a distal portion of the delivery device taken along line AA in FIG. 3. [Diagram 5] FIG. 2 is a side cross-sectional view of a delivery device and a guidewire. [Figure 6] 1 is a side cross-sectional view of a delivery device within a body vessel with a guidewire extending out of a distal end of the delivery device. [Figure 7] FIG. 13 is a side cross-sectional view of a delivery device with the guidewire retracted proximally within the delivery device. [Figure 8] FIG. 13 is a side cross-sectional view of a delivery device with a guidewire extending out of a side port of the delivery device. [Figure 9] FIG. 1C is a side cross-sectional view of a delivery device and guidewire in a rapid exchange configuration. [Figure 10] A side cross-sectional view of a delivery device with a guidewire extending through the distal end and side port of the delivery device. [Figure 11] A side cross-sectional view of a delivery device within a body vessel with a guidewire extending through the distal end and side port of the delivery device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0006] In one or more embodiments, not all of the components shown in each figure may be required, and one or more embodiments may include additional components not shown in the figures. The configuration and type of components may be changed without departing from the scope of the present disclosure. Additional, different, or fewer components may be utilized within the scope of the present disclosure.

[0007] The detailed description set forth below is intended as a description of various embodiments and is not intended to represent the only embodiments in which the present technology can be practiced. As will be understood by those skilled in the art, the described embodiments can be modified in a variety of different ways, all without departing from the scope of the present disclosure. Thus, the drawings and description should be regarded as illustrative in nature, and not restrictive.

[0008] The present technology generally relates to systems, methods, and devices for crossing and treating CTOs. Although CTOs are discussed, it will be understood that the devices and methods described herein can facilitate treatment of a variety of conditions.

[0009] It may be desirable to provide a system and / or device that facilitates access to a target anatomical structure (e.g., a vascular CTO) and further facilitates an intervention to restore flow across the CTO. Various stages of such an operation may involve the operation of multiple tools to access, traverse, and treat the target anatomical structure. The systems and methods described herein are directed to devices that provide multiple functions at different stages. By providing different functionality at different stages, the need to swap and replace tools at different stages can be reduced or eliminated. Thus, such operations can be completed more quickly, efficiently, and safely.

[0010] Specific details of several embodiments of the present technology are described herein with reference to Figures 1 through 11. Many of the embodiments are described below with respect to devices and methods for crossing and / or treating CTOs, however, any vascular occlusion may be crossed and / or treated within the scope of the present technology in addition to those described herein (e.g., total occlusions, partial occlusions, occlusions resulting from thrombus, occlusions resulting from embolism, occlusions resulting from atherosclerosis, etc.). Additionally, other embodiments of the present technology may have different configurations, components, or procedures than those described herein. For example, other embodiments may include additional elements and features other than those described herein, or other embodiments may not include some of the elements and features shown and described herein.

[0011] 1, the system can include a delivery device 100 for delivering another device through its lumen. The delivery device 100 can include a connector 106 at and / or defining a proximal end portion 102 of the delivery device 100 and providing a handle, luer, connector, and / or hub. For example, the connector 106 can include mating and / or receiving features for securely connecting to other components. The connector 106 can include a touhy bourst seal configured to secure the position of one or more devices within the delivery device 100.

[0012] The delivery device 100 can further include a distal tip 190 at and / or defining the distal end portion 104 of the delivery device 100. The distal tip 190 can include a radiopaque distal tip (e.g., polymer, tungsten, barium, etc.). The delivery device 100 can further include a shaft 110 extending between the connector 106 and the distal tip 190. The connector 106 can be configured to be disposed at a location external to the patient, and the shaft 110 can be configured to place the distal tip 190 at or near a total or partial occlusion inside a blood vessel of the patient (e.g., intravascularly). The delivery device 100 can have an internal lumen extending from the connector 106 to the distal tip 190 and / or the side port 150. The delivery device 100 can include a strain relief element between the shaft 110 and another portion of the connector 106. For example, the strain relief element may surround or engage the shaft 110 at its proximal end.

[0013] The delivery device 100 can receive one or more devices (e.g., guidewire 200) through the distal end portion 104 and into the lumen. The delivery device 100 can receive one or more devices (e.g., crossing device 300) through the proximal end portion 102 and into the lumen.

[0014] Shaft 110 can be sized and shaped to enter a target site (e.g., a treatment site) within a patient's blood vessel. In one embodiment, for example, shaft 110 has a length of about 150 cm to about 180 cm and a suitable cross-sectional dimension for placement within the vasculature of a subject. The length of shaft 110 can be a working length, such as a length that can be placed within the vasculature of a subject. In some embodiments, for example, the working length is from about 70 cm to about 300 cm, from about 150 cm to about 250 cm, or about 70 cm, about 80 cm, about 90 cm, about 100 cm, about 110 cm, about 120 cm, about 130 cm, about 140 cm, about 150 cm, about 160 cm, about 170 cm, about 180 cm, about 190 cm, about 200 cm, about 210 cm, about 220 cm, about 230 cm, about 240 cm, about 250 cm, about 260 cm, about 270 cm, about 280 cm, about 290 cm, or about 300 cm.

[0015] 2-4, the shaft 110 may be or may include a catheter shaft lined with an inner layer (e.g., PTFE, hydrophilic coating, etc.) and / or coated with an outer layer (e.g., polymer, stainless steel braid, polyimide, etc.). A side port 150 may be formed in the shaft 110 at a location between the proximal end and the distal end portion 104 of the delivery device 100. The side port 150 connects the lumen 140 to the space adjacent the exterior of the shaft 110. The side port 150 may be molded, laser cut, or otherwise formed in the shaft 110.

[0016] As shown in FIGS. 2 and 3, the flap member 160 can be disposed at or near the side port 150. For example, the flap member 160 can extend from a portion of the shaft 110 adjacent the side port 150. The flap member 160 can extend at least partially into the lumen 140 and at least one configuration thereof. The flap member 160 can be integrally formed (e.g., monolithic) with at least a portion of the shaft 110 and / or can be securely coupled thereto. As used herein, a monolithic structure is a structure integrally formed of a single material, rather than separate pieces joined together by an interface. For example, the flap member 160 and the shaft 110 can be unitary and / or one-piece structures. By providing the flap member 160 and the shaft 110 as monolithic, one-piece, and / or one-piece structures, these components need not include interfaces or discontinuities as would occur in assembled parts. Thus, the monolithic, one-piece, and / or unitary flap member 160 and shaft 110 can be manufactured to more precise and consistent dimensions and can provide greater structural support.

[0017] The flap member 160 may include a metal such as a shape memory alloy (e.g., Nitinol). The flap member 160 may be heat set (e.g., annealed) into a certain configuration (e.g., a first position) such that the flap member 160 is biased into such a position and / or configuration without an external force biasing the flap member 160.

[0018] 4, in at least one configuration, the flap member 160 can extend from the shaft 110 into the lumen 140. The flap member 160 can block at least a portion of the lumen 140 for an object traveling along the longitudinal axis 108 of the delivery device 100 (e.g., within the lumen 140). The flap member 160 can be positioned and shaped to allow an object to remain in the lumen 140 when traversing the flap member 160 if the object approaches the flap member 160 from one side thereof. The flap member 160 can be positioned and shaped to deflect an object to exit the lumen 140 through the side port 150 when traversing the flap member 160 if the object approaches the flap member 160 from another side thereof.

[0019] 4, flap member 160 can include a distal end that facilitates interaction with, or passage of, guidewire 200 or other interventional devices. For example, the distal end can include a concave shape that receives a portion of guidewire 200. Such a shape can help orient guidewire 200 in a preferred position relative to flap member 160 and retain guidewire 200 in a particular position (e.g., radially and / or circumferentially) within lumen 140 as guidewire 200 advances longitudinally within lumen 140.

[0020] 5-8, the delivery device 100 can be manipulated to facilitate placement of other devices relative to a body vessel and / or an object therein (e.g., a CTO). As shown in FIG. 5, a guidewire 200 can be inserted from the distal end portion 104 of the delivery device 100. As the guidewire 200 passes through the flap member 160, the flap member 160 can deflect as needed to allow the guidewire 200 to pass through the lumen 140 and over the flap member 160. Additionally, the flap member 160 can retain the guidewire 200 within the lumen 140 and prevent the guidewire 200 from exiting the shaft 110 through the side port 150. Thus, the guidewire 200 can be directed to the proximal end of the delivery device 100 for manipulation by a user at the proximal end.

[0021] As shown in FIG. 6 , the delivery device 100 and guidewire 200 can be positioned within the patient's anatomy (e.g., adjacent to an occlusion 180 within a blood vessel). At least a portion of the guidewire 200 can remain within the lumen 140 and distal to the flap member 160. Thus, the flap member 160 can remain in a deflected (e.g., second) position. The guidewire 200 can be manipulated to penetrate the occlusion. Additionally or alternatively, another device (e.g., coupled to the guidewire 200 and / or inserted from the proximal end of the delivery device) can be manipulated to penetrate the occlusion. The guidewire 200 and / or another device can move within the lumen 140 and can be held in a partially distal position relative to the flap member 160 by limiting its proximal retraction.

[0022] 7, guidewire 200 can be manipulated to facilitate subintimal penetration and / or crossing of the occlusion. Guidewire 200 can be retracted proximally until it is completely proximal of flap member 160. Once guidewire 200 no longer straddles flap member 160, flap member 160 can return to a biased (e.g., first) position in which flap member 160 blocks at least a portion of lumen 140.

[0023] As shown in FIG. 8 , the flap member 160 can direct the guidewire 200 through the side port 150. The guidewire 200 can be advanced distally until it contacts the flap member 160. In its biased position, the flap member 160 can provide a surface that directs the guidewire 200 through the side port 150 and away from the lumen 140 toward the vessel wall. For example, the flap member 160 can form an oblique (i.e., not parallel or perpendicular) angle with respect to the longitudinal axis 108 of the shaft 110. Thus, by advancing the guidewire 200 longitudinally relative to the flap member 160, the flap member 160 redirects the guidewire 200 out of the side port 150 in a direction that forms an oblique angle with respect to the longitudinal axis 108 of the shaft 110.

[0024] Guidewire 200 may be manipulated to penetrate the vessel wall. Additionally or alternatively, another device (e.g., coupled to guidewire 200 and / or inserted from the proximal end of a delivery device) may be manipulated to penetrate the vessel wall. Such penetration may allow guidewire 200 to navigate around occlusion 180, thereby providing access to its opposing side. Such access may be used to restore and enhance flow across occlusion 180.

[0025] Additionally or alternatively, in one or more of the steps described herein and / or in additional steps, the guidewire 200 may be used in conjunction with or replaced by an interventional device. An example of such an interventional device is the crossing device disclosed in International Patent Application PCT / US2010 / 047170, entitled "SYSTEMS, METHODS AND DEVICES FOR ABLATION, CROSSING, AND CUTTING OF OCCLUSIONS," filed August 30, 2010, which is incorporated herein by reference in its entirety. For example, the interventional device may be actuated (e.g., advanced, retracted, rotated, etc.) to provide a mechanism (e.g., blades, edges, cutting tools, etc.) that facilitates penetration or other action against the target anatomical structure (e.g., CTO, vessel wall, etc.).

[0026] The delivery device can include any number of side ports 150 and flap members 160. Different side ports 150 and flap members 160 can be proximal, distal, and / or axially overlapping with respect to one another. Different side ports 150 and flap members 160 can be in the same radial plane with respect to one another or in different radial planes. Devices (e.g., guidewires, interventional devices, etc.) extending through different side ports can extend through the same proximal end and / or lumen of the shaft or can extend through different locations.

[0027] 9-11, a delivery device 400 can be manipulated to facilitate device manipulation and / or fluid flow relative to a body vessel and / or objects therein (e.g., CTOs). As shown in FIG. 9, a guidewire 200 can be inserted from a distal end 404 of the delivery device 400. Such manipulation can be performed while the delivery device 400 is outside the patient's body.

[0028] 10, the flap member 460 can direct the guidewire 200 through the side port 450. The guidewire 200 can be advanced proximally until it contacts the flap member 460. In its biased position, the flap member 460 can provide a surface that directs the guidewire 200 through the side port 450 and away from the lumen 440.

[0029] As shown in FIG. 11, a delivery device 400 can be placed in the patient's anatomy (eg, a blood vessel) along with a guidewire 200.

[0030] At least a portion of the guidewire 200 can remain within the lumen 140 and distal to the flap member 160. The guidewire 200 and / or another device can be moved within the lumen 140 and / or alongside the shaft 410.

[0031] Fluid may be provided through lumen 440 for injection into a target anatomical structure. For example, fluid may be provided through lumen 440 to a proximal end of delivery device 400. When the fluid flow strikes flap member 460, flap member 460 may deflect as needed to allow fluid to pass through lumen 440 and past flap member 460. Additionally, flap member 460 may retain at least some of the fluid within lumen 440 and may prevent at least some of the fluid from exiting shaft 410 through side port 450. Thus, fluid may be directed to distal end 404 of delivery device 400 for injection. Such manipulation may be performed while guidewire 200 and / or another device remain at least partially within lumen 440 (e.g., distal to flap member 460 and / or side port 450).

[0032] The delivery device can include any number of side ports 450 and flap members 460. Different side ports 450 and flap members 460 can be proximal, distal, and / or axially overlapping with respect to one another. Different side ports 450 and flap members 460 can be in the same radial plane with respect to one another or in different radial planes. Devices (e.g., guidewires, interventional devices, etc.) extending through different side ports can extend through the same distal end and / or lumen of the shaft or can extend through different locations.

[0033] Although delivery device 100 and delivery device 400 are shown as separate devices, it will be understood that a single delivery device may include one or more of each of side port 150, flap member 160, side port 450, and / or flap member 460. Side port 150 and flap member 160 may be proximal, distal, and / or axially overlapping side port 450 and flap member 460. Side port 150 and flap member 160 may be in the same radial plane relative to the radial plane of side port 450 and flap member 460 or in different radial planes.

[0034] The vessels within which the delivery devices described herein may be sized and shaped for placement include arteries such as coronary arteries, peripheral arteries, carotid arteries, Circle of Willis, anterior cerebral arteries, middle cerebral arteries, posterior cerebral arteries, lenticulostriate arteries, renal arteries, femoral arteries, cerebral veins, saphenous veins, arteriovenous fistulas, or any other vessel that may contain a treatment site. Other vessels are envisioned as well, and the delivery device may be shaped and / or selected according to known destinations and / or travel routes within the patient's body.

[0035] Thus, the systems and methods described herein provide multiple functions at different stages. By providing different functionality at different stages, the need to swap and replace tools at different stages can be reduced or eliminated, thus allowing such operations to be completed more quickly, efficiently, and safely.

[0036] Various examples of aspects of this disclosure are itemized below for convenience and are provided as examples and not as limitations of the technology.

[0037] Section A: A delivery device comprising: a shaft defining a proximal end, a distal end, and a lumen extending between the proximal and distal ends; a side port extending through the shaft at a portion of the shaft between the proximal and distal ends; and a flap member extending from the shaft distal to the side port toward the proximal end of the delivery device, the flap member configured to transition from a first position blocking at least a portion of the lumen to a second position blocking at least a portion of the side port.

[0038] Section B: A delivery device comprising: a shaft defining a proximal end, a distal end, and a lumen extending between the proximal and distal ends; a side port extending through the shaft at a portion of the shaft between the proximal and distal ends; and a flap member extending from the shaft proximal to the side port toward a distal end of the delivery device, the flap member configured to transition from a first position blocking at least a portion of the lumen to a second position blocking at least a portion of the side port.

[0039] Section C: A method comprising inserting a proximal portion of a guidewire through a distal end of a delivery device and into a lumen of the delivery device and over a flap member of the delivery device; retracting the guidewire until the distal portion of the guidewire is proximal to the flap member; and advancing the guidewire until the flap member directs the distal portion of the guidewire out of the lumen through a side port of the delivery device.

[0040] One or more of the above clauses may include one or more of the features described below. It is noted that any of the following clauses may be combined with one another in any combination and placed into their own independent clauses, e.g., clauses A, B, or C.

[0041] Node 1: The flap member is biased towards a first position.

[0042] Node 2: An interventional device extending within the lumen, across the side port, and capable of being retracted proximally so that it is completely proximal to the flap member.

[0043] Node 3: The flap member is biased towards the interventional device.

[0044] Node 4: The interventional device is a guidewire.

[0045] Node 5: While in the first position, the flap member extends from the side port to a wall of the shaft opposite the side port.

[0046] Node 6: The ends of the flap members define a concave shape.

[0047] Node 7: While in the first position, the flap member forms an oblique angle with respect to the longitudinal axis of the shaft.

[0048] Section 8: The distal end of the delivery device, the length of the lumen distal to the side port, and the interventional device extending through the side port.

[0049] Node 9: After inserting and before retracting, advance a guidewire to the target anatomy and advance a delivery device over the guidewire to the target anatomy.

[0050] Node 10: The flap member is biased to a first position away from a second position blocking at least a portion of the lumen and blocking at least a portion of the side port.

[0051] Node 11: Insertion transitions the flap member from the second position to the first position.

[0052] Reference to an element in the singular is not intended to mean just one, unless specifically stated otherwise, but rather means one or more. For example, "a" module may refer to one or more modules. An element followed by "a," "an," "the," or "said" does not, without further constraints, exclude the presence of more of the same element.

[0053] Headings and subheadings, if any, are used for convenience only and do not limit the invention. The word exemplary is used to mean serve as an example or illustration. To the extent terms such as including, having, etc. are used, such terms are intended to be inclusive in a manner similar to the manner in which the term comprising is interpreted when used as a transitional term in the claims. Relative terms such as first and second may be used to distinguish one entity or act from another without necessarily requiring or implying an actual, such as a relationship or order, between the entities or acts.

[0054] Phrases such as "an aspect," "the aspect," "another aspect," "some aspects," "one or more aspects," "embodiment," "the embodiment," "another embodiment," "some embodiments," "one or more embodiments," "example," "the embodiment," "another embodiment," "an example," "one or more examples," "configuration," "the configuration," "another configuration," "some configurations," "one or more configurations," "the technology," "disclosure," "the disclosure," and other variations thereof, are used for convenience and do not imply that disclosure associated with such phrases is essential to the technology or that such disclosure applies to all configurations of the technology. Disclosure associated with such phrases may apply to all configurations, or to one or more configurations. Disclosure associated with such phrases may provide one or more examples. Phrases such as "an aspect" or "some aspects" may refer to one or more "aspects," and vice versa, which applies to the other aforementioned phrases as well.

[0055] The phrase "at least one" preceding a list of items, with the term "and" or "or" separating any of the items, modifies the entire list and not each member of the list. The phrase "at least one" does not require the selection of at least one item, but rather allows the phrase to mean including at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. By way of example, the phrase "at least one of A, B, and C" or "at least one of A, B, or C" refers, respectively, to only A, only B, or only C, any combination of A, B, and C, and / or at least one of each of A, B, and C.

[0056] It is understood that the particular order or hierarchy of steps, operations, or processes disclosed is an example of an example approach. It is understood that the particular order or hierarchy of steps, operations, or processes may be performed in different orders unless otherwise specified. Some of the steps, operations, or processes may be performed simultaneously. Method claims in the appended claims present various steps, operations, or process elements in an example order, and are not meant to be limited to the particular order or hierarchy presented. They may be performed sequentially, serially, in parallel, or in different orders. It is understood that the instructions, operations, and systems described may generally be integrated into a single software / hardware product or packaged into multiple software / hardware products.

[0057] In one aspect, a term such as "coupled" may refer to being directly coupled. In another aspect, a term such as "coupled" may refer to being indirectly coupled.

[0058] Terms such as "top," "bottom," "front," "back," "side," "horizontal," and "vertical" refer to any frame of reference other than the usual gravitational frame of reference, and thus may refer to directions upward, downward, diagonal, or horizontal in a gravitational frame of reference.

[0059] In general, unless the context indicates otherwise, the terms "distal" and "proximal" in this disclosure refer to a location relative to an operator or an operator's control device. For example, "proximal" can refer to a location closer to the operator or an operator's control device, and "distal" can refer to a location farther away from the operator or an operator's control device.

[0060] The present disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. In some cases, well-known structures and components are shown in block diagrams to avoid obscuring the concepts of the present technology. The present disclosure provides various examples of the present technology, but the present technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art. Also, the principles described herein may be applied to other aspects.

[0061] All structural and functional equivalents to the elements of the various aspects described throughout the disclosure that are known or that later become known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, nothing disclosed herein is made available to the public, regardless of whether such disclosure is expressly recited in the claims. No claim element is to be construed under 35 U.S.C. ...

[0062] The title, background, brief description of the drawings, abstract, and drawings are hereby incorporated into this disclosure and are provided as illustrative examples of the disclosure and not as a limiting description. They are submitted with the understanding that they will not be used to limit the scope or meaning of the claims. It will be further appreciated that in the detailed description, the description provides an illustrative example, and that various features have been grouped into various embodiments for the purpose of streamlining the disclosure. The method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Instead, as the claims reflect, inventive subject matter lies in less than all features of a single disclosed structure or operation. The claims are hereby incorporated into the detailed description, with each claim standing on its own as separately claimed subject matter.

[0063] The claims are not intended to be limited to the embodiments described herein, but are to be accorded the full scope consistent with the language of the claims and include all legal equivalents. Nonetheless, none of the claims are intended to, and should not be construed to, cover subject matter that does not comply with the requirements of applicable patent law.

Claims

1. A delivery device comprising: A proximal end portion; A distal end portion. a shaft defining a lumen extending between the proximal end and the distal end; a side port extending through the shaft at a portion of the shaft between the proximal end and the distal end; a flap member extending from the shaft toward the proximal end of the delivery device distal to the side port, a distal end of the flap member defining a concave shape for receiving an interventional device and configured to transition from a first position blocking at least a portion of the lumen to a second position blocking at least a portion of the side port; A delivery device comprising:

2. The delivery device of claim 1 , wherein the flap member is biased toward the first position.

3. 10. The delivery device of claim 1, further comprising an interventional device extending within the lumen across the side port, the interventional device being retractable proximally to be completely proximal of the flap member.

4. The delivery device of claim 3 , wherein the flap member is biased toward the interventional device.

5. The delivery device of claim 3 , wherein the interventional device is a guidewire.

6. The delivery device of claim 1 , wherein while in the first position, the flap member extends from the side port to a wall of the shaft opposite the side port.

7. The delivery device of claim 1 , wherein while in the first position, the flap member forms an oblique angle with respect to a longitudinal axis of the shaft.

8. A proximal end portion; A distal end portion. a shaft defining a lumen extending between the proximal end and the distal end, a longitudinal portion of the shaft defining an inner diameter; a side port extending through the shaft at a portion of the shaft between the proximal end and the distal end; a flap member extending from a first radial side of the shaft, a distal end of the flap member defining a concave shape having an apex and a pair of protruding ends opposite the apex, the flap member comprising: a first position in which a distal end of the flap member extends to a second radial side of the shaft beyond the inner diameter defined by the longitudinal portion of the shaft to block at least a portion of the lumen; a second position blocking at least a portion of the side port; and The delivery device is configured to transition between

9. The delivery device of claim 8 , wherein the flap member is biased toward the first position.

10. The delivery device of claim 8 , further comprising an interventional device extending within the lumen across the side port, the interventional device being retractable proximally into full approximation of the flap member.

11. The delivery device of claim 10 , wherein the flap member is biased toward the interventional device.

12. The delivery device of claim 10 , wherein the interventional device is a guidewire.

13. The delivery device of claim 10 , wherein the interventional device is a crossing device comprising a sharp-tipped blade.

14. The delivery device of claim 8 , wherein while in the first position, the flap member forms an oblique angle with respect to a longitudinal axis of the shaft.

15. The delivery device of claim 8 , wherein the flap member extends distally from the shaft toward the distal end of the delivery device.

16. The delivery device of claim 8 , wherein the flap member extends proximally from the shaft toward the proximal end of the delivery device.

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