Multidirectional blood vessel entry device

Abstract

An intravascular device delivery system includes (a) a sheath device for insertion of one or more wires or catheters within a blood vessel of a subject, the sheath device comprising: (i) an elongated member with a lumen, the lumen oriented to enter the subject in a retrograde direction; (ii) a deployable anchoring element convertible between an initial state that generally lies along the lumen to a deployed state that expands the anchoring element to anchor the sheath device within a blood vessel; and (b) a catheter configured for insertion through the lumen of the elongated member and into the blood vessel, the catheter comprising a shape memory material and the catheter further comprising: (i) a lumen configured to communicate a guidewire therethrough; and (ii) a distal portion characterized as having a curvature in a resting state.

Description

107329.000007 / 24-0003MULTIDIRECTIONAL BLOOD VESSEL ENTRY DEVICERELATED APPLICATIONS

[0001] The present application claims priority to and the benefit of United States patent application no. 63 / 697,136, “Multidirectional Blood Vessel Entry Device” (filed September 20, 2024). All foregoing applications are incorporated herein by reference in their entirety for any and all purposes.TECHNICAL FIELD

[0002] The present disclosure relates to anchorable sheaths and methods for multidirectional access of blood vessels using anchorable sheaths.BACKGROUND

[0003] Peripheral artery disease (PAD) is a common condition that occurs when arteries in the extremities, particularly the legs, become clogged with plaque. PAD affects over 12 million Americans and has been increasing over the years. Computed tomography (CT) angiograms are the gold standard for diagnosis of PAD, which is recommended before any surgical or procedure intervention. For patients with severe symptoms or failure to respond to medical therapy, endovascular procedures such as percutaneous angioplasties and stents are the recommended treatments. However, the current method for performing an angiogram from an antegrade approach is difficult due to the patient’s body habitus. As a result, the current access is unidirectional and does not fully image all the arteries that could be affected by PAD. In order to fully image these arteries, physicians can perform multiple procedures or create a second access point. These methods increase the cost of diagnosis and treatment. Additionally, the additional access point is the most common complication in angiograms. Moreover, the current sheaths depend on their long length to anchor in the vessels, which covers the vessel walls and leaves more areas untreated. There is thus a clear need in the art for improved catheter and sheath designs that permit positioning from more than one direction.107329.000007 / 24-0003SUMMARY

[0004] In meeting the long-felt needs described above, the present disclosure provides a catheter and sheath that facilitates bidirectional positioning and directionality of wire placement to simplify access of blood vessels and optimal wire placement for angiograms.

[0005] Disclosed herein is an intravascular device delivery system, comprising: (a) a sheath device for insertion of one or more wires or catheters within a blood vessel of a subject, the sheath device comprising: (i) an elongated member with a lumen extending between a distal end and a proximal end, the lumen oriented to enter the subject in a direction, the direction optionally being a retrograde direction; (ii) a deployable anchoring element convertible between an initial state that generally lies along the lumen to a deployed state that expands the anchoring element, the deployable anchoring element configured to anchor the sheath device within a blood vessel when the deployable anchoring element is in the deployed state; and (b) a catheter configured for insertion through the lumen of the elongated member of the sheath and into the blood vessel, the catheter comprising a shape memory material, and the catheter further comprising: (i) a lumen configured to communicate a guidewire therethrough; and (ii) a distal portion of the catheter characterized as having a curvature in a resting state, the curvature being reduced with communication of the distal portion within the lumen of the catheter, and the curvature returning with emergence of the distal portion from the elongated member of the sheath.

[0006] Also disclosed is a method, comprising: inserting a first guidewire into a blood vessel; inserting the sheath device of a catheter delivery system according to Aspect 1 into the blood vessel and over the first guidewire; converting the deployable anchoring element to the deployed state so as to anchor the sheath device in the blood vessel; advancing the catheter through the sheath device and into the blood vessel such that the distal portion of the catheter emerges from the sheath device and regains at least some of the curvature of the distal portion; and advancing a second guidewire through the catheter.

[0007] Further provided is a kit, comprising: an catheter device having a proximal portion and a distal portion, the distal portion characterized as having a curvature in a resting state; an anchorable sheath device, the anchorable sheath device being configured to receive the catheter device and permit passage of the distal portion of the catheter device therethrough; and optionally at least one guidewire, the at least one guidewire configured for107329.000007 / 24-0003 communication through the catheter device and / or the anchorable sheath device, and optionally, a dilator / introducer configured for communication through the sheath and configured to receive a catheter device and / or a guidewire.

[0008] Additionally provided is a kit, comprising: a catheter device having a proximal portion and a distal portion, the distal portion characterized as having a curvature in a resting state; an anchorable sheath device, the anchorable sheath device being configured to receive the catheter device and permit passage of the distal portion of the catheter device therethrough; and optionally at least one guidewire, the at least one guidewire configured for communication through the catheter device and / or the anchorable sheath device, and optionally a dilator / introducer configured for communication through the sheath and configured to receive a catheter device and / or a guidewire.

[0009] Also disclosed is an intravascular device delivery system, comprising: a sheath having a lumen; and a catheter configured for insertion through a lumen of the sheath and into the blood vessel, the catheter comprising a shape memory material, the catheter defining a lumen configured to communicate a guidewire therethrough; and a distal portion of the catheter having a curvature in a resting state, the curvature being reduced with communication of the distal portion within the lumen of the catheter, and the curvature returning with emergence of the distal portion from the elongated member of the sheath, the curvature exceeding about 180 degrees.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] In the drawings, which are not necessarily drawn to scale, like numerals can describe similar components in different views. Like numerals having different letter suffixes can represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various aspects discussed in the present document. In the drawings:

[0011] FIG. 1 A depicts a schematic of an exemplary intravascular device delivery system comprising two infusion ports placed in an artery of a subject. FIG. IB depicts a schematic of an exemplary intravascular device delivery system comprising two infusion ports and a bleed-back port placed in an artery of a subject.

[0012] FIG. 2 A depicts an exemplary sheath device as contemplated by the present disclosure. The image on the left displays the sheath device with the anchoring element in a107329.000007 / 24-0003 stowed configuration significantly flush to the sheath. The image on the right depicts the sheath device with the anchoring element in a deployed configuration.

[0013] FIG. 2B depicts an exemplary catheter as contemplated by the present disclosure.

[0014] FIG. 2C depicts images of the distal end of an exemplary catheter, including (right image) an exemplary catheter exhibiting a coiled shape.

[0015] FIG. 3 depicts an exemplary sheath as contemplated by the present disclosure including depth and orientation markers.

[0016] FIG. 4 depicts a schematic of an exemplary method of operating the catheter delivery system as contemplated by the present disclosure.

[0017] FIG. 5 depicts an exemplary method of the present disclosure.

[0018] FIGS. 6 A to 6C depict exemplary deployable anchoring elements as contemplated by the present disclosure. FIG. 6A depicts an exemplary deployable U-prong- shaped anchoring element. FIG. 6B depicts an exemplary double strut propeller-shaped anchor. FIG. 6C depicts and exemplary single-strut propeller shaped anchoring element.

[0019] FIGS. 7A to 7D depict exemplary anchor deployment mechanisms as contemplated by the present disclosure. FIG. 7A depicts a pusher tube type of anchor deployment mechanism. FIG. 7B depicts a slider deployment sheath type of anchor deployment mechanism. FIG. 7C depicts a deployment wire type of anchor deployment mechanism. FIG. 7D depicts a deployment dilator / introducer type of anchor deployment mechanism.

[0020] FIGS. 8 A to 8D provide exemplary intravascular device delivery system as contemplated by the present disclosure. FIG. 8A provides an exemplary intravascular device delivery system showing an exemplary inflatable or expandable balloon in an inflated state. FIG. 8B shows an exemplary intravascular device delivery system showing a dilator / introducer 400 inserted through hub 122. FIG. 8C shows an exemplary intravascular device delivery system showing a catheter 200 with a guidewire 300 inserted through the catheter lumen 240 reducing the curvature of the distal end 230 of the catheter as it is inserted through the elongate member 110 of the sheath 100. FIG. 8D shows an exemplary intravascular device delivery system with the guidewire 300 removed allowing the distal end 230 of the catheter 200 to recoil and form a curvature.107329.000007 / 24-0003

[0021] FIG. 9 depicts a schematic of an exemplary intravascular device delivery system with the guidewire 300 removed allowing the distal end 230 of the catheter 200 (not shown) to form a coil thus allowing the catheter to enter to vessel without touching the opposite wall of the blood vessel in which it is inserted.

[0022] FIG. 10 depicts exemplary balloon designs. The balloon shown in the left panel is a disk-like design for securing the distal end of the sheath with the lumen of a blood vessel in a non-occluding manner. The balloon in the right panel is a disk balloon combined with a semi-spherical balloon that when inflated can anchor the sheath and also at least partially occlude blood flow through the blood vessel into which it is inserted.

[0023] FIGS. 11 A to 11C provide a schematic of the sheath showing a plurality of lumens along the length of the sheath, which lumens can include a working lumen, one or more inflation lumens, a bleed-back lumen connected to a bleed-back port; the sheath can also include an inflatable balloon anchoring device. FIG. 11 A shows a cross-sectional view of the distal end of sheath. FIG. 1 IB shows a front-on view looking down the central lumen of the sheath, which central lumen can receive a catheter and / or guidewire, and also shows an inflated balloon anchoring device, an infusion lumen, and a bleed-back lumen. FIG. 11C shows a side view of sheath showing a sampling / infusion / bleed-back lumen extending along the outer surface of the primary lumen of the sheath.DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0024] The present disclosure may be understood more readily by reference to the following detailed description of desired embodiments and the examples included therein.

[0025] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In case of conflict, the present document, including definitions, will control. Preferred methods and materials are described below, although methods and materials similar or equivalent to those described herein can be used in practice or testing. All publications, patent applications, patents and other references mentioned herein are incorporated by reference in their entirety. The materials, methods, and examples disclosed herein are illustrative only and not intended to be limiting.107329.000007 / 24-0003

[0026] The singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.

[0027] As used in the specification and in the claims, the term "comprising" can include the embodiments "consisting of and "consisting essentially of.” The terms “comprise(s),” “include(s),” “having,” “has,” “can,” “contain(s),” and variants thereof, as used herein, are intended to be open-ended transitional phrases, terms, or words that require the presence of the named ingredients / steps and permit the presence of other ingredients / steps. However, such description should be construed as also describing compositions or processes as "consisting of and "consisting essentially of the enumerated ingredients / steps, which allows the presence of only the named ingredients / steps, along with any impurities that might result therefrom, and excludes other ingredients / steps.

[0028] As used herein, the terms “about” and “at or about” mean that the amount or value in question can be the value designated some other value approximately or about the same. It is generally understood, as used herein, that it is the nominal value indicated ±10% variation unless otherwise indicated or inferred. The term is intended to convey that similar values promote equivalent results or effects recited in the claims. That is, it is understood that amounts, sizes, formulations, parameters, and other quantities and characteristics are not and need not be exact, but can be approximate and / or larger or smaller, as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art. In general, an amount, size, formulation, parameter or other quantity or characteristic is “about” or “approximate” whether or not expressly stated to be such. It is understood that where “about” is used before a quantitative value, the parameter also includes the specific quantitative value itself, unless specifically stated otherwise.

[0029] Unless indicated to the contrary, the numerical values should be understood to include numerical values which are the same when reduced to the same number of significant figures and numerical values which differ from the stated value by less than the experimental error of conventional measurement technique of the type described in the present application to determine the value.

[0030] All ranges disclosed herein are inclusive of the recited endpoint and independently of the endpoints. The endpoints of the ranges and any values disclosed herein are not limited to the precise range or value; they are sufficiently imprecise to include values approximating these ranges and / or values.107329.000007 / 24-0003

[0031] As used herein, approximating language can be applied to modify any quantitative representation that can vary without resulting in a change in the basic function to which it is related. Accordingly, a value modified by a term or terms, such as “about” and “substantially,” may not be limited to the precise value specified, in some cases. In at least some instances, the approximating language can correspond to the precision of an instrument for measuring the value. The modifier “about” should also be considered as disclosing the range defined by the absolute values of the two endpoints. For example, the expression “from about 2 to about 4” also discloses the range “from 2 to 4.” The term “about” can refer to plus or minus 10% of the indicated number. For example, “about 10%” can indicate a range of 9% to 11%, and “about 1” can mean from 0.9-1.1. Other meanings of “about” can be apparent from the context, such as rounding off, so, for example “about 1” can also mean from 0.5 to 1.4. Further, the term “comprising” should be understood as having its open- ended meaning of “including,” but the term also includes the closed meaning of the term “consisting.” For example, a composition that comprises components A and B can be a composition that includes A, B, and other components, but can also be a composition made of A and B only. Any documents cited herein are incorporated by reference in their entireties for any and all purposes.

[0032] The present disclosure provides a novel intravascular device delivery system, shown in FIG. 1 for providing multidirectional access to a blood vessel of a subject in need thereof. The blood vessel can include any suitable blood vessel for catheterization. For example, the blood vessel can include a femoral artery, a femoral vein, a brachial artery, an axillary artery, a carotid artery and the like. The intravascular device delivery system is suitable for performing one or more procedures that utilize catheterization, including, for example, an angiogram, an angioplasty, an angio-ablation, stent placement and the like. The intravascular device delivery system 10 can include a sheath device 100 and a catheter device 200. The intravascular device delivery system can also include one or more guidewires 300.

[0033] Referring now to FIG. 2 A, the intravascular device delivery system 10 includes a sheath device 100 for introducing one or more wires or catheters into a blood vessel of a subject. The sheath device 100 includes an elongated member 110. The elongated member includes a proximal end 120 and distal end 130 and has a lumen 140 extending between the distal end 130 and the proximal end 120. The lumen 140 provides access to the blood vessel from outside the body of the subject. The lumen 140 is oriented to107329.000007 / 24-0003 enter the subject in a particular direction. In some embodiments, the direction is a retrograde direction.

[0034] The distal end 130 of the elongated member 100 includes a deployable anchoring element 150. The deployable anchoring element 150 is convertible between an initial state that generally lies along the lumen (shown in the left panel of FIG. 2 A) and a deployed state that expands the anchoring element (shown in the right panel of FIG. 2A). The deployable anchoring element 150 is configured to anchor the sheath device within a blood vessel when the deployable anchoring element 150 is in the deployed state.

[0035] In some embodiments, the deployable anchoring element 150 can include a reversibly expandable element such as, for example, an expandable wire mesh cage-shaped anchor (not shown), a deployable U-prong-shaped anchor (FIG. 6A), a double strut propeller shaped-anchor (FIG. 6B), a single-strut propeller shaped anchor (FIG. 6C) or a combination thereof. In some embodiments, the expandable wire mesh cage-shaped anchor can be constructed of an expandable mesh material such as a shape-memory wire material. In some embodiments the reversibly expandable element is similar to an expandable stent-like structure. The reversibly expandable element can permit the passage of blood through the blood vessel with little to no obstruction while anchoring the sheath. The reversibly expandable element can be constructed of a biocompatible metal material. For example, the biocompatible metal material can include one or more of a 316L stainless steel (316L SS), a platinum-iridium (Pt-Ir) alloy, tantalum (Ta), nitinol (Ni-Ti), cobalt-chromium alloy(605L), and / or a titanium (Ti) nitinol.

[0036] Referring now to FIGs. 7A to 7D, the reversibly expandable element can be deployed using one or more deployment mechanisms. The one or more deployment mechanisms can include, for example, a pusher tube (shown in FIG. 7A), a deployment sheath (shown in FIG. 7B), one or more deployment wires (shown in FIG. 7C), a deployment dilator (shown in FIG. 7D), and the like.

[0037] Referring now to FIGs. 8A to 8D, an exemplary sheath having a triple lumen design for placing a coiled catheter 200 within the lumen of a blood vessel is shown. As shown in FIG. 8 A, a sheath 100 can be anchored within the lumen of a blood vessel by inflating an inflatable balloon 150 within the lumen of a blood vessel. As shown in FIG. 8B, the sheath 100 can be advanced into the vessel over a guidewire 200 using a dilator / introducer 400. The dilator / introducer 400 can in some embodiments provide a107329.000007 / 24-0003 smooth tapered transition allowing the sheath 100 to smoothly transition through the skin, subcutaneous tissue and the vessel wall. After the sheath 100 is introduced into the vessel, the dilator / introducer 400 can be removed. Balloon 150 can then be inflated and the sheath 100 can be pulled back until it reaches the vessel wall where the inflated balloon 150 causes resistance and provides a mechanical stop preventing the sheath 100 from exiting the blood vessel. As described elsewhere herein, a balloon can function to anchor the device to the blood vessel. A balloon can also, however, function to at least partially occlude blood flow in the blood vessel; a balloon can also completely occlude blood flow in the blood vessel. A balloon can be configured to be inflatable only to a degree that anchors the device. A balloon can also, however, be configured to be inflatable to a degree that the balloon anchors the device and also at least partially - or even completely - occludes blood flow in the blood vessel. A catheter 200 as contemplated herein can then be inserted over the guidewire 300 into the vessel lumen, as shown in FIG. 8C. After the catheter 200 has been placed in the blood vessel lumen, the guidewire 300 is withdrawn thereby returning the curvature of the distal end 230 of the catheter 200 to its coiled configuration, shown in FIG. 8D. In certain aspects, the catheter 200 is steerable by applying torque to the catheter 200 to enable horizontal directional change, while partially withdrawing the curved portion of distal end 230 of the catheter 200 into the sheath 100 enables vertical directional change. Thus, the combination of catheter movements allows full global directional control. Reinsertion of the guidewire 300 through the catheter lumen 240 allows for redirection of the guidewire 300 in the opposite direction of the original puncture.

[0038] In some embodiments, the deployable anchoring element 150 comprises a biocompatible inflatable balloon. The inflatable balloon can be constructed of one or more biocompatible materials including for example, one or more nylons, polyethylene terephthalate (PET), one or more polyurethanes, one or more polyolefins (e.g., HDPE), and the like. The inflatable balloon can be inflated by introducing one or more inflation fluids via deployment port 124b. For example, one or more fluids such as air, saline, and / or one or more other biocompatible fluids can be introduced via deployment port 124b and used to inflate deployable anchoring element 150 for securing sheath 100 to a desire position in a subject. The inflatable balloon can have a disk-like shape, as shown in FIG. 2A, FIG. 3, FIG. 9 and FIG. 10 left panel. The inflatable balloon can have a disk-like shape coupled to a semi- spherical shape, as shown in FIG. 10, right panel. A balloon can, in some embodiments,107329.000007 / 24-0003 include a first portion configured to anchor the device to a blood vessel and a second portion that is configured to at least partially occlude the blood vessel. The first portion and the second portion can be in fluid communication with one another such that they can be inflated simultaneously. This is not, however, a requirement, as a balloon can be constructed such that the first portion and the second portion are independently inflated. A balloon can also be constructed such that the first portion and the second portion are inflated sequentially.

[0039] The deployable anchoring element 150 can expand to a diameter at least 10% greater than the outer diameter of the sheath so as to anchor the distal end of the sheath to an inner portion of the blood vessel. For example the deployable anchoring element can expand to a diameter that is greater than the diameter of the sheath 100 by an amount of at least 10%, an amount in the range of from about 10% to about 20%, from about 20% to about 30%, from about 30% to about 40%, from about 40% to about 50%, from about 50% to about 60%, from about 60% to about 70%, from about 70% to about 80%, from about 80% to about 90%, from about 90% to about 100%, from about 100% to about 120%, from about 120% to about 140%, from about 140% to about 160%, from about 160% to about 180%, from about 180% to about 200%, and so on, including any and all increments therebetween.

[0040] The deployable anchoring element 150 can be positioned a distance from the end of distal portion 130 so that the sheath is sufficiently anchored within the blood vessel but does not obstruct blood flow within the blood vessel. In some embodiments, the deployable anchoring element 150 can be positioned a distance from the distal end 130 of the sheath of up to about 1 mm, from about 1 mm to about 2 mm, from about 2 mm to about 3 mm, from about 3 mm to about 4 mm, from about 4 mm to about 5 mm, from about 5 mm to about 6 mm, from about 6 mm to about 7 mm, from about 7 mm to about 8 mm, from about 8 mm to about 9 mm, from about 9 mm to about 10 mm, from about 10 mm to about 11 mm, from about 11 mm to about 12 mm, from about 12 mm to about 13 mm, from about 13 mm to about 14 mm, from about 14 mm to about 15 mm, from about 15 mm to about 16 mm, from about 16 mm to about 17 mm, from about 17 mm to about 18 mm, from about 18 mm to about 19 mm, from about 19 mm to about 20 mm, including any and all increments therebetween.

[0041] In some embodiments, the sheath device 100 can include a hub 122 positioned at the proximal end of the elongated member and comprising one or more ports107329.000007 / 24-0003 and configured for receiving one or more catheters, one or more guidewires, or a combination thereof, that enters the lumen and advances into the blood vessel.

[0042] In some embodiments, such as the embodiment of FIG. 3, the sheath device 100 includes at the proximal end 120 a sheath orientation indicator 126 for tracking the position of the distal portion 130 of the sheath 100. The sheath orientation indicatorl26 can include, for example, an arrow, a notch, a tab, or the like. The sheath orientation indicator 126 can be used to aid a user in positioning the sheath in a blood vessel so that the distal portion 130 of the sheath enters the blood stream in a retrograde orientation, an anterograde orientation, or the like. The sheath orientation indicator 126 can be used to aid a user in positioning the catheter in a blood vessel so that the distal portion 240 of the catheter enters the blood stream in a retrograde orientation, an anterograde orientation, or the like. In some embodiments, the sheath orientation indicator 126 can be used to aid a user in adjusting the positioning and / or repositioning the distal portion 130 from an anterograde orientation to a retrograde orientation, and vice versa. In some embodiments, the sheath device 100 include one or more depth indicators 127 for indicating to the user how deep into the body the sheath is positioned. The depth indicators 127 can include numbers, graded hash marks, grade lines, or the like corresponding to one or more preferred depths.

[0043] In some embodiments, the sheath device can include one or more ports 124. For example, the one or more ports 124 can include one or more injection ports 124a for introducing one or more fluids into the patient through the sheath 124, and / or one or more deployment ports 124b configured for actuating the deployable anchoring element 150; port 124b can be, for example, a balloon deployment port as shown in FIG. 8 A. The one or more ports injection ports 124a can be configured for passing one or more fluids to and / or through the sheath 100. For example, the one or more injection ports 124a can be configured for flushing the sheath and / or catheter with a flushing fluid including, for example, saline. The one or more ports 124 can also include an injection port 124a for introducing one or more therapeutic agents, contrast agents and the like. The one or more therapeutic agents can include saline, a thrombolytic agent, or a combination thereof. The contrast agent can include any suitable contrast agent for performing an angiogram including for example, one or more iodinated contrast agents and the like. The one or more ports 124 can include a bleed-back port 124c for receiving blood from the lumen of a blood vessel thereby indicating or confirming placement of the distal end 130 of the sheath 100 within the lumen of the blood107329.000007 / 24-0003 vessel of interest. The bleed-back port 124c can be connected to a bleed-back lumen 111, as shown in FIGS. 11A-11C.

[0044] The one or more ports 124 can include a fitting including, for example, a Luer lock fitting for engaging with, for example, a syringe for introducing the one or more fluids described herein. The one or more ports 124 can be configured with one or more valves such as a stopcock to regulate the passage of fluid through the port.

[0045] Referring now to FIG. 2B, the intravascular device delivery system 10 includes a catheter 200 configured for insertion through the sheath lumen 140 of the elongated member 100 and into the blood vessel. The catheter includes a proximal portion 220 a distal portion 230 and a catheter lumen 240. The catheter lumen 240 can be configured for receiving a guidewire 300 introduced at the proximal end 200 and configured to communicate the guidewire from outside the subject to the lumen of the blood vessel. The distal portion 240 is characterized as having a curvature in a resting state, as shown in FIG. 2C and FIG. 9. In some embodiments, at least the distal portion 240 of the catheter 200 is constructed of a shape memory material. The memory shape material can include, for example, nitinol (Ni-Ti). At least the distal portion 240 of catheter 200 can have a resting state curvature that is reduced to a nearly linear configuration when in communication with the sheath 100 and returns to its resting curvature upon emergence from the sheath including for example, emergence from the distal end 130 of the sheath 100, shown in FIG. 8D and FIG. 9. The resting curvature of at least the distal portion 240 of the catheter 200 can also be reduced by, for example, a guidewire introduced through the catheter lumen 240 can significantly reduce the resting curvature of distal portion 230, as shown in FIG. 8C. In some embodiments, the distal portion 230 of catheter 200 can include a radio-opaque marker for visualizing the distal portion 230 once placed in a blood vessel.

[0046] The distal portion 230 of catheter 200 can be formed to have a resting state curvature of about 270°. The distal portion 230 of catheter 200 can have a resting state curvature of at least 270°. The distal portion 230 of catheter 200 can have a resting state curvature in the range of from about 240° to about 310°. The distal portion 240 of catheter 200 can have a resting state curvature of from about 200° to about 220°, from about 220° to about 240°, from about 240° to about 260°, from about 260° to about 280°, from about 280° to about 300°, from about 300° to about 320°, from about 320° to about 340°, from about 340“° to about 360° including any and all increments therebetween. In some embodiments, the distal107329.000007 / 24-0003 portion 230 of catheter 200 can be formed to have a resting state curvature of at least about 180°. The distal portion 230 of catheter 200 can have a resting state curvature in the range of about 181° to about 300°, from about 250° to about 290°, or any and all increments therebetween.

[0047] The distal portion 230 of catheter 200 can have a resting curvature that has a resting (fully coiled) diameter of less than 1 cm. The distal portion 230 can have a curvature with a resting diameter of less than about 1 cm, less than about 0.9 cm, less than about 0.8 cm, less than about 0.7 cm, less than about 0.6 cm, less than about 0.5 cm, less than about 0.4 cm, less than about 0.3 cm, less than about 0.2 cm less than about 0.1 cm, including any and all increments therebetween.

[0048] In some embodiments, the proximal portion 220 of catheter 200 includes an orientation indicator for tracking the position of the distal portion 230 of the catheter 200. The orientation indicator can include, for example, an arrow, a notch, a tab, or the like. The orientation indicator can allow a user to track the position of the distal opening of the catheter lumen 240, the degree of curvature of distal portion 230, and / or a combination thereof. The orientation indicator can be used to aid a user in positioning the catheter in a blood vessel so that the distal portion 230 of the catheter enters the blood stream in a retrograde orientation. The orientation indicator can be used to aid a user in positioning the catheter in a blood vessel so that the distal portion 230 of the catheter enters the blood stream in an anterograde orientation. In some embodiments, the orientation indicator can be used to aid a user in adjusting the positioning and / or repositioning the distal portion 230 from an anterograde orientation to a retrograde orientation, and vice versa.

[0049] In some embodiments, the distal portion 230 of the catheter 200 can include one opening at the distal end for exiting the lumen 240. In some embodiments, the opening at the distal end is configured allowing the passage of a fluid into the lumen of a blood vessel, and / or for permitting a guidewire to exit the catheter lumen 240 from the distal portion 230 of the catheter 200. In some embodiments, the distal portion 230 of catheter 200 includes one or more holes or openings. For example, distal portion 230 can include a primary hole or opening at a distal end. Distal portion 230 can include one or more additional openings or holes for introducing one or more agents including, for example, one or more contrast agents, one or more therapeutic agents and the like into the lumen of a blood vessel. The one or more contrast agents can include any suitable contrast agent for performing an angiogram107329.000007 / 24-0003 including for example, one or more iodinated contrast agents and the like. The one or more therapeutic agents can include saline, a thrombolytic agent, or a combination thereof.

[0050] Methods

[0051] The present disclosure provides method 500 for delivering a catheter into a blood vessel using the catheter delivery system as described herein. Referring now to FIG. 5, embodiments of step S502 of method 500 include inserting a first guidewire into a blood vessel. The blood vessel can include any suitable blood vessel for catheterization including for example a femoral artery, a femoral vein, a brachial artery, an axillary artery, and the like. The guidewire can be introduced through an access point prepared by a clinician.

[0052] Embodiments of step S504 of method 500 include introducing the sheath device 100 of an intravascular device delivery system 10 into the blood vessel and over the first guidewire. The sheath device 100 can be introduced by inserting the sheath 100 through an incision prepared by a clinician using suitable techniques as understood in the art.

[0053] Embodiments of step S506 of method 500 include converting the deployable anchoring element 150 from a resting state where the deployable anchoring element 150 is significantly flush with the sheath 100 to a deployed state where the deployable anchoring element is expanded to a diameter greater than that of the sheath 100 so as to anchor the sheath device in the blood vessel. For example the deployable anchoring element can be expanded to a diameter that is greater than the diameter of the sheath 100 by an amount of at least 10%, an amount in the range of from about 10% to about 20%, from about 20% to about 30%, from about 30% to about 40%, from about 40% to about 50%, from about 50% to about 60%, from about 60% to about 70%, from about 70% to about 80%, from about 80% to about 90%, from about 90% to about 100%, from about 100% to about 120%, from about 120% to about 140%, from about 140% to about 160%, from about 160% to about 180%, from about 180% to about 200%, and so on, including any and all increments therebetween.

[0054] In some embodiments, the deployable anchoring element 150 can include an expandable mesh material. The expandable mesh material can include a biocompatible metal material. The biocompatible metal material can include one or more of a 316L stainless steel (316L SS), a platinum-iridium (Pt-Ir) alloy, tantalum (Ta), nitinol (Ni-Ti), cobalt-chromium alloy (605L), and a titanium (Ti) nitinol.

[0055] In some embodiments, the deployable anchoring element 150 comprises a biocompatible expandable balloon. In such embodiments, the deployable anchoring element107329.000007 / 24-0003 can be deployed by introducing one or more fluids through a deployment port 124b at the proximal end 120 of elongate body 100, thereby deploying or inflating deployable anchoring element 150.

[0056] Embodiments of step S508 of the methods 500 include advancing the catheter through the sheath device and into the blood vessel such that the distal portion of the catheter emerges from the sheath device and regains at least some of the curvature of the distal portion. The curvature of distal portion 230 is reduced when the catheter 200 is introduced into the sheath lumen 140 of sheath 100 so that the catheter 200 can pass through the lumen 140. The orientation of the curvature of distal end 230 of catheter 200 can be tracked by observing an orientation indicator at proximal end 220 of catheter 200. The orientation indicator can provide an operator with information related to the orientation of the curvature of distal portion 230. That is, the orientation indicator can be used to indicate whether the curvature of distal portion 230 is oriented in an upstream direction (retrograde) or downstream (anterograde) direction within the blood vessel of the subject. The operator can rotate the catheter 200 within the lumen 140 of sheath 100 so that the distal portion 240 is oriented in a desired direction. In some embodiments, step S508 includes advancing the catheter 200 through the sheath device 100 and into the blood vessel such that the distal portion is positioned in a retrograde orientation.

[0057] Embodiments of step S510 of the methods 500 include advancing a second guidewire through the catheter lumen 240. In some embodiments, advancing the second guidewire through the catheter reduces the regained curvature of the distal portion of the catheter.

[0058] Kits

[0059] In certain aspects, the present disclosure provides a kit that includes a catheter device 200 as described herein. The catheter includes a proximal portion 220 and a distal portion 230 where the distal portion 230 is characterized as having a curvature in a resting state. The kit also includes an anchorable sheath device 100. The anchorable sheath device 100 can be configured to receive the catheter device 200 and permit passage of the distal portion 230 of the catheter device 200 through a sheath lumen 140 in the anchorable sheath device 100. In some embodiments, the kit can also include at least one guidewire 300. The at least one guidewire 300 can be configured to pass through a catheter lumen 240 in the107329.000007 / 24-0003 catheter device 200 and / or the through a sheath lumen 140 in the anchorable sheath device 100.

[0060] Aspects

[0061] The following Aspects are illustrative only and do not limit the scope of the present disclosure or the appended claims. Any part or parts of any one or more Aspects can be combined with any part or parts of any one or more other Aspects.

[0062] Aspect 1. A intravascular device delivery system, comprising: (a) a sheath device for insertion of one or more wires or catheters within a blood vessel of a subject, the sheath device comprising: (i) an elongated member with a lumen extending between a distal end and a proximal end, the lumen oriented to enter the subject in a direction, the direction optionally being a retrograde direction; (ii) a deployable anchoring element convertible between an initial state that generally lies along the lumen to a deployed state that expands the anchoring element, the deployable anchoring element configured to anchor the sheath device within a blood vessel when the deployable anchoring element is in the deployed state; and (b) a catheter configured for insertion through the lumen of the elongated member of the sheath and into the blood vessel, the catheter comprising a shape memory material, and the catheter further comprising: (i) a lumen configured to communicate a guidewire therethrough; and (ii) a distal portion of the catheter characterized as having a curvature in a resting state, the curvature being reduced with communication of the distal portion within the lumen of the catheter, and the curvature returning with emergence of the distal portion from the elongated member of the sheath.

[0063] Aspect 2. The intravascular device delivery system of Aspect 1, wherein the sheath device further comprises a hub positioned at the proximal end of the elongated member and comprising one or more ports and configured for receiving one or more catheters, one or more guidewires, or a combination thereof, that enters the lumen and advances into the blood vessel.

[0064] Aspect 3. The intravascular device delivery system of Aspect 1 or 2, wherein the sheath device further comprises one or more ports comprising a deployment port configured for actuating the deployable anchoring element.

[0065] Aspect 4. The intravascular device delivery system of Aspect 3, wherein the one or more ports comprise a bleed-back port configured to receive blood from a vessel lumen so as to indicate placement of the catheter within a vessel lumen. In some aspects, the107329.000007 / 24-0003 intravascular device delivery system of Aspect 3 comprises a triple lumen sheath. Each sheath of the triple lumen sheath can be configured to engage with one of the ports.

[0066] Aspect 5. The intravascular device delivery system of any one of Aspects 1 to 4, wherein the catheter further comprises a proximal portion comprising an orientation indicator.

[0067] Aspect 6. The intravascular device delivery system of any one of Aspects 1 to 5, wherein the deployable anchoring element comprises a reversibly expandable element comprising an expandable wire mesh cage-shaped anchor, a deployable U-prong-shaped anchor, a double strut propeller shaped-anchor, a single-strut propeller shaped anchor or a combination thereof.

[0068] Aspect 7. The intravascular device delivery system of Aspect 5, wherein the reversibly expandable element comprises a biocompatible metal material.

[0069] Aspect 8. The intravascular device delivery system of Aspect 6, wherein the biocompatible metal material comprises one or more of a 316L stainless steel (316L SS), a platinum-iridium (Pt-Ir) alloy, tantalum (Ta), nitinol (Ni-Ti), cobalt-chromium alloy(605L), and a titanium (Ti)nitinol.

[0070] Aspect 9. The intravascular device delivery system of any one of Aspects 1 to 9, wherein the deployable anchoring element comprises a biocompatible expandable balloon.

[0071] Aspect 10. The intravascular device delivery system of Aspect 9, wherein the biocompatible expandable balloon defines, when expanded, a first portion that defines a disk shape or a disk-like shape.

[0072] Aspect 11. The intravascular device delivery system of Aspect 9, wherein the biocompatible expandable balloon defines, when expanded, (i) a disk shape or a disk-like shape coupled to (ii) a semi -spherical shape.

[0073] Aspect 12. The intravascular device delivery system of any one of Aspects 1 to 11, wherein the curvature comprises about 270 degrees.

[0074] Aspect 13. The intravascular device delivery system of any one of Aspects 1 to 12, wherein the distal portion comprises one or more openings for introducing one or more fluids into the blood stream of the subject.107329.000007 / 24-0003

[0075] Aspect 14. The intravascular device delivery system of Aspect 13, wherein the one or more fluids comprise one or more contrast agents, one or more thrombolytic agents or a combination thereof.

[0076] Aspect 15. The intravascular device delivery system of any one of Aspects 1-14, wherein the blood vessel comprises a femoral artery.

[0077] Aspect 16. A method, comprising: inserting a first guidewire into a blood vessel; inserting the sheath device of a catheter delivery system according to Aspect 1 into the blood vessel and over the first guidewire; converting the deployable anchoring element to the deployed state so as to anchor the sheath device in the blood vessel; advancing the catheter through the sheath device and into the blood vessel such that the distal portion of the catheter emerges from the sheath device and regains at least some of the curvature of the distal portion; and advancing a second guidewire through the catheter.

[0078] Aspect 17. The method of Aspect 16, wherein advancing the second guidewire through the catheter reduces the regained curvature of the distal portion of the catheter.

[0079] Aspect 18. The method of Aspect 16 or 17, wherein the deployable anchoring element comprises an expandable mesh material.

[0080] Aspect 19. The method of Aspect 18, wherein the expandable mesh material comprises a biocompatible metal material.

[0081] Aspect 20. The method of Aspect 19, wherein the biocompatible metal material comprises one or more of a 316L stainless steel (316L SS), a platinum-iridium (Pt- Ir) alloy, tantalum (Ta), nitinol (Ni-Ti), cobalt-chromium alloy(605L), and a titanium (Ti)ni tinol.

[0082] Aspect 21. The method of Aspect 16 or 17, wherein the deployable anchoring element comprises a biocompatible expandable balloon.

[0083] Aspect 22. The method of any one of Aspects 16 to 21, wherein the blood vessel comprises a femoral artery.

[0084] Aspect 23. A kit, comprising: an catheter device having a proximal portion and a distal portion, the distal portion characterized as having a curvature in a resting state; an anchorable sheath device, the anchorable sheath device being configured to receive the catheter device and permit passage of the distal portion of the catheter device therethrough; and optionally at least one guidewire, the at least one guidewire configured for107329.000007 / 24-0003 communication through the catheter device and / or the anchorable sheath device, and optionally, a dilator / introducer configured for communication through the sheath and configured to receive a catheter device and / or a guidewire.

[0085] Aspect 24. A kit, comprising: a catheter device having a proximal portion and a distal portion, the distal portion characterized as having a curvature in a resting state; an anchorable sheath device, the anchorable sheath device being configured to receive the catheter device and permit passage of the distal portion of the catheter device therethrough; and optionally at least one guidewire, the at least one guidewire configured for communication through the catheter device and / or the anchorable sheath device, and optionally a dilator / introducer configured for communication through the sheath and configured to receive a catheter device and / or a guidewire.

[0086] Aspect 25. An intravascular device delivery system, comprising: a sheath having a lumen; and a catheter configured for insertion through a lumen of the sheath and into the blood vessel, the catheter comprising a shape memory material, the catheter defining a lumen configured to communicate a guidewire therethrough; and a distal portion of the catheter having a curvature in a resting state, the curvature being reduced with communication of the distal portion within the lumen of the catheter, and the curvature returning with emergence of the distal portion from the elongated member of the sheath, the curvature exceeding about 180 degrees.

[0087] Aspect 26. The intravascular device delivery system of Aspect 25, wherein the curvature is from about 181 to about 300 degrees, optionally from about 250 to about 290 degrees.

[0088] Aspect 27. The intravascular device delivery system of any one of Aspects 25-26, further comprising a deployable anchoring element convertible between an initial state that optionally lies along the lumen to a deployed state that expands the anchoring element, the deployable anchoring element configured to anchor the sheath device within a blood vessel when the deployable anchoring element is in the deployed state

[0089] Aspect 28. The intravascular device delivery system of Aspect 27, wherein the deployable anchoring element comprises a biocompatible expandable balloon.

[0090] Aspect 29. The intravascular device delivery system of Aspect 28, wherein the biocompatible expandable balloon defines, when expanded, a first portion that defines a disk shape or a disk-like shape.107329.000007 / 24-0003

[0091] Aspect 30. The intravascular device delivery system of Aspect 29, wherein the biocompatible expandable balloon defines, when expanded, (i) a disk shape or a disk-like shape coupled to (ii) a semi -spherical shape.

Claims

107329.000007 / 24-0003What is Claimed:

1. An intravascular device delivery system, comprising:(a) a sheath device for insertion of one or more wires or catheters within a blood vessel of a subject, the sheath device comprising:(i) an elongated member with a lumen extending between a distal end and a proximal end, the lumen oriented to enter the subject in a direction, the direction optionally being a retrograde direction;(ii) a deployable anchoring element convertible between an initial state that optionally lies along the lumen to a deployed state that expands the anchoring element, the deployable anchoring element configured to anchor the sheath device within a blood vessel when the deployable anchoring element is in the deployed state; and(b) a catheter configured for insertion through the lumen of the elongated member of the sheath and into the blood vessel, the catheter comprising a shape memory material, and the catheter further comprising:(i) a lumen configured to communicate a guidewire therethrough; and(ii) a distal portion of the catheter characterized as having a curvature in a resting state, the curvature being reduced with communication of the distal portion within the lumen of the catheter, and the curvature returning with emergence of the distal portion from the elongated member of the sheath.

2. The intravascular device delivery system of claim 1, wherein the sheath device further comprises a hub positioned at the proximal end of the elongated member and comprising one or more ports and configured for receiving one or more catheters, one or more guidewires, or a combination thereof, that enters the lumen and advances into the blood vessel.107329.000007 / 24-00033. The intravascular device delivery system of claim 1 or 2, wherein the sheath device further comprises one or more ports, the one or more ports comprising a deployment port configured for actuating the deployable anchoring element.

4. The intravascular device delivery system of claim 3, wherein the one or more ports comprise a bleed-back port configured to receive blood from a vessel lumen so as to indicate placement of the catheter within a vessel lumen.

5. The intravascular device delivery system of any one of claims 1 to 4, wherein the catheter further comprises a proximal portion comprising an orientation indicator.

6. The intravascular device delivery system of any one of claims 1 to 5, wherein the deployable anchoring element comprises a reversibly expandable element comprising an expandable wire mesh cage-shaped anchor, a deployable U-prong-shaped anchor, a double strut propeller shaped-anchor, a single-strut propeller shaped anchor or a combination thereof.

7. The intravascular device delivery system of claim 6, wherein the reversibly expandable element comprises a biocompatible metal material.

8. The intravascular device delivery system of claim 7, wherein the biocompatible metal material comprises any one or more of a 316L stainless steel (316L SS), a platinumiridium (Pt-Ir) alloy, tantalum (Ta), nitinol (Ni-Ti), cobalt-chromium alloy(605L), and a titanium (Ti)nitinol.

9. The intravascular device delivery system of any one of claim 1 to 5, wherein the deployable anchoring element comprises a biocompatible expandable balloon.

10. The intravascular device delivery system of claim 9, wherein the biocompatible expandable balloon defines, when expanded, a first portion that defines a disk shape or a disk-like shape.

11. The intravascular device delivery system of claim 9, wherein the biocompatible expandable balloon defines, when expanded, (i) a disk shape or a disk-like shape coupled to (ii) a semi -spherical shape.107329.000007 / 24-000312. The intravascular device delivery system of any one of claim 1 to 11, wherein the curvature comprises about 270 degrees.

13. The intravascular device delivery system of any one of claims 1 to 12, wherein the distal portion comprises one or more openings for introducing one or more fluids into the blood stream of the subject.

14. The intravascular device delivery system of claim 13, wherein the one or more fluids comprise one or more contrast agents, one or more thrombolytic agents or a combination thereof.

15. The intravascular device delivery system of any one of claims 1-14, wherein the blood vessel comprises a femoral artery.

16. A method, comprising: inserting a first guidewire into a blood vessel; inserting the sheath device of a catheter delivery system according to claim 1 into the blood vessel and over the first guidewire; converting the deployable anchoring element to the deployed state so as to anchor the sheath device in the blood vessel; advancing the catheter through the sheath device and into the blood vessel such that the distal portion of the catheter emerges from the sheath device and regains at least some of the curvature of the distal portion; and advancing a second guidewire through the catheter.

17. The method of claim 16, wherein advancing the second guidewire through the catheter reduces the regained curvature of the distal portion of the catheter.

18. The method of claim 16 or 17, wherein the deployable anchoring element comprises an expandable mesh material.107329.000007 / 24-000319. The method of claim 18, wherein the expandable mesh material comprises a biocompatible metal material.

20. The method of claim 19, wherein the biocompatible metal material comprises one or more of a 316L stainless steel (316L SS), a platinum -iridium (Pt-Ir) alloy, tantalum (Ta), nitinol (Ni-Ti), cobalt-chromium alloy(605L), and a titanium (Ti)nitinol.

21. The method of claim 16, wherein the deployable anchoring element comprises a biocompatible expandable balloon.

22. The method of any one of claims 16-21, wherein the blood vessel comprises a femoral artery.

23. A kit, comprising: a catheter device having a proximal portion and a distal portion, the distal portion characterized as having a curvature in a resting state, the curvature being reduced with communication of the distal portion within the lumen of the catheter, and the curvature returning with emergence of the distal portion from the elongated member of the sheath; an anchorable sheath device, the anchorable sheath device being configured to receive the catheter device and permit passage of the distal portion of the catheter device therethrough; and optionally, at least one guidewire, the at least one guidewire configured for communication through the catheter device and / or the anchorable sheath device, and optionally, a dilator / introducer configured for communication through the sheath and configured to receive a catheter device and / or a guidewire.

24. A kit, comprising: a catheter device having a proximal portion and a distal portion, the distal portion characterized as having a curvature in a resting state;107329.000007 / 24-0003 an anchorable sheath device, the anchorable sheath device being configured to receive the catheter device and permit passage of the distal portion of the catheter device therethrough; and optionally, at least one guidewire, the at least one guidewire configured for communication through the catheter device and / or the anchorable sheath device, and optionally, a dilator / introducer configured for communication through the sheath and configured to receive a catheter device and / or a guidewire.

25. An intravascular device delivery system, comprising: a sheath having a lumen; and a catheter configured for insertion through a lumen of the sheath and into the blood vessel, the catheter comprising a shape memory material, the catheter defining a lumen configured to communicate a guidewire therethrough; and a distal portion of the catheter having a curvature in a resting state, the curvature being reduced with communication of the distal portion within the lumen of the catheter, and the curvature returning with emergence of the distal portion from the elongated member of the sheath, the curvature exceeding about 180 degrees.

26. The intravascular device delivery system of claim 25, wherein the curvature is from about 181 to about 300 degrees, optionally from about 250 to about 290 degrees.

27. The intravascular device delivery system of claim 25, further comprising a deployable anchoring element convertible between an initial state that optionally lies along the lumen to a deployed state that expands the anchoring element, the deployable107329.000007 / 24-0003 anchoring element configured to anchor the sheath device within a blood vessel when the deployable anchoring element is in the deployed state28. The intravascular device delivery system of claim 27, wherein the deployable anchoring element comprises a biocompatible expandable balloon.

29. The intravascular device delivery system of claim 28, wherein the biocompatible expandable balloon defines, when expanded, a first portion that defines a disk shape or a disk-like shape.

30. The intravascular device delivery system of claim 29, wherein the biocompatible expandable balloon defines, when expanded, (i) a disk shape or a disk-like shape coupled to (ii) a semi -spherical shape.

Images