Systems and methods for utilizing an antegrade sheath

Abstract

To help prevent limb ischemia resulting from the use of mechanical circulatory support, various systems and devices, such as sheaths configured for antegrade and retrograde insertion into a patient's vasculature, are provided. Such systems and devices may include, for example, various combinations of hub, sheath, and needle designs to allow for the insertion of multiple medical devices into a patient's vasculature while minimizing vascular obstruction.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Patent No. 63 / 444,536, filed February 9, 2023, the entire contents of which are incorporated herein by reference.

[0002] Technical Field The present disclosure relates to methods, devices, and systems used in the prevention of limb ischemia resulting from, for example, the use of mechanical circulatory support. [Background technology]

[0003] background This section is intended to introduce the reader to various aspects of art that may be related to various aspects of the present invention, which are described and / or claimed below. This discussion is believed to be helpful in providing the reader with background information to facilitate a better understanding of the various aspects of the present invention. Accordingly, it should be understood that these statements are to be read in this light, and not as admissions of prior art.

[0004] Intravascular medical devices, such as percutaneous pumps (e.g., IMPELLA® heart pump by Abiomed, Inc., Danvers, Massachusetts), catheters, guidewires, balloon angioplasty catheters, delivery sheaths, and implant delivery systems, can be used during minimally invasive procedures in the cardiovascular, cerebrovascular, and peripheral vasculature. Such medical devices can be introduced into a patient's body in a variety of ways. In one common approach, a pump assembly is inserted via a catheterization procedure through the femoral artery using a sheath system, which can remain in place throughout its lifespan. In other scenarios, the sheath system used to facilitate pump placement may be peeled off the pump catheter, and a secondary sheath assembled to the catheter is advanced into the vascular system for long-term access site management (e.g., hemostasis, pump stability). Summary of the Invention [Means for solving the problem]

[0005] overview In various aspects, a retrograde sheath may be provided. The sheath may include a hub. The hub may include a first opening extending from the proximal end to the distal end of the hub. The hub may include a second opening extending from the proximal end to the distal end of the hub. The sheath may include a first cannula. The first cannula may be coupled to the distal end of the hub. The first opening may be operably coupled to the cannula. The second opening may include a membrane or a hemostatic valve. The first opening may have a larger diameter at the proximal end such that the second opening connects to the first opening in the proximal hub at a point between the distal end and the proximal end. The first opening may be configured to be directed toward a blood vessel, and the second opening may be configured to be directed toward the same blood vessel. The first cannula may be configured to be directed into a blood vessel in a first direction, and the second cannula may be configured to be directed into a blood vessel in a second direction different from the first direction. The first cannula may have a larger diameter at the proximal end than at the distal end. The proximal end may include a first lumen extending a first length (such as the entire length of the cannula) toward the distal end and a second lumen parallel to the first lumen extending a distance toward the distal end less than the first length.

[0006] In various aspects, a retrograde sheath may be provided. The sheath may include a hub. The hub may include a first opening extending from the proximal end to the distal end of the hub. The sheath may include a distal cannula having a distal cannula body coupled to the distal end of the hub. The first opening may be operably coupled to the distal cannula. The sheath may include an attachment coupled to the proximal end of the distal cannula body or to the hub, the attachment comprising a separate cannula body. The distal cannula may be configured to be directed toward a blood vessel, and the separate cannula body may be configured to point toward the same blood vessel. The attachment may be removably coupled to the distal cannula body or the hub. The attachment may be permanently coupled to the distal cannula body or the hub.

[0007] In various aspects, a retrograde sheath may be provided. The sheath may include a proximal hub coupled to a cannula body. The retrograde sheath may include an adjustable portion. The adjustable portion may include a distal end of the proximal hub and / or a proximal end of the cannula body. The adjustable portion may be located within the distal end of the proximal hub. The adjustable portion may be coupled between the distal end of the proximal hub and the proximal end of the cannula body. The adjustable portion may include an articulation joint. The adjustable portion may be configured to allow rotation in only one dimension. The adjustable portion may be configured to allow rotation in only one dimension or in two dimensions. The distal end of the cannula body may be oriented to face proximally. The outer surface of the distal end of the cannula body may be separated from the outer surface of the central portion of the cannula body by a distance of 0.25 to 1 mm after being bent 180 degrees.

[0008] In various aspects, an introducer sheath may be provided. The sheath may include a tubular body. The tubular body may include a first lumen providing a first pathway extending from a proximal end of the tubular body to a distal end of the tubular body. The distal end of the tubular body may be configured to create a micropuncture in a blood vessel. The distal end of the tubular body may be configured to have an outer diameter of 21 French or less. The tubular body may include a proximal portion extending from the proximal end of the tubular body and defining a second lumen providing a second pathway extending distally. The second lumen may have an opening at the distal end of the proximal portion configured to be positioned outside the blood vessel into which the first lumen is inserted. The second lumen may be configured to slidably receive a curved needle or wire so that the second lumen may enter the blood vessel at a location different from the location where the first lumen enters the blood vessel. The sheath may include a hub operably coupled to the tubular body. The hub may include a Luer connection. The hub may include one Luer connection operably coupled to each lumen in the tubular body. The hub may include a first opening configured to be coupled to a proximal end of the first lumen. The hub may include a second opening configured to be coupled to a proximal end of the second lumen. The first opening may be configured to slidably receive one or more medical devices configured to be inserted into a blood vessel in a first direction. The second opening may be configured to slidably receive one or more medical devices configured to be inserted into a blood vessel in a second direction different from the first direction.

[0009] In various aspects, a system may be provided. The system may include a needle operably coupled to a hub or handle. The system may include a device including a proximal hub coupled to a proximal end of a distal tubular member. The distal tubular member may include a distal tip curved to point in a direction different from a central portion of the distal tubular member. The system may include a catheter having a hub coupled to the distal tubular member, the catheter configured to slidably receive the needle and, after the needle is removed, to slidably receive the device. The needle may be configured to puncture a blood vessel at multiple locations. The distal tip may have a fixed separation distance from the central portion. The distal tip may have a variable separation distance from the central portion. The needle may be dual-needle. A first needle of the dual-needle may be configured to provide an access point for an antegrade sheath. A second needle of the dual-needle may be configured to provide an access point for a retrograde sheath.

[0010] In various aspects, a device may be provided. The device may include a first needle, a second needle, and a proximal hub. The first needle may define a first lumen extending from a distal end to a proximal end of the first needle. The first needle may have a first length from the distal end to the proximal end. The second needle may define a second lumen extending from a distal end to a proximal end of the second needle. The second needle may have a second length from the distal end to the proximal end. The first needle and the second needle may be connected to a proximal hub. The proximal hub may have a first opening and a second opening. Each opening may extend from the proximal end to the distal end of the proximal hub. The first opening may be operably coupled to the first lumen. The second opening may be operably coupled to the second lumen. The first length may be longer than the second length. The first length may be equal to the second length. Each opening and lumen can be configured to slidably receive one or more medical devices.

[0011] In various embodiments, a needle may be provided. The needle may include a sidewall defining a first lumen extending from the proximal end to the distal end of the needle and a second lumen extending from the proximal end to an outlet in an intermediate portion of the sidewall. The outlet may be configured to be a predetermined distance from the distal end of the needle such that both the distal end and the outlet are positioned within a blood vessel during use.

[0012] In various aspects, a device may be provided. The device may include a hub coupled to at least one tubular member defining a first lumen and a second lumen. The at least one tubular member may extend distally away from the hub. The first lumen may be configured to slidably receive a medical device. The device may include one or more valves disposed within the hub. The hub may define a predetermined volume of space coupled to the first lumen and the second lumen, such that a path from a distal opening of the first lumen to a distal opening of the second lumen may be formed by passing through the predetermined volume of space. The first lumen may be configured such that excess space exists within the first lumen after the medical device is inserted.

[0013] In various embodiments, an inverted needle may be provided that includes one or more side walls defining a lumen extending from the proximal end toward the distal end of the inverted needle. The lumen may be configured to exit through an opening in a side of the inverted needle proximal to the distal end.

[0014] In various embodiments, a device may be provided. The device may include a tubular member having a proximal end coupled to the distal end of a proximal hub. The tubular member may have one or more regions pierceable by the distal end of a medical device that are smaller than the entire region of the tubular member. One or more regions may be free of a reinforcing coil. One or more regions may have a sidewall thickness that is thinner than the sidewall thickness at different locations. One or more regions may be laser cut and then filled with a filling material. The filling material may be a polymer. The filling material may be different from the polymer forming the sidewall at different locations. The one or more regions may be within a portion of the tubular member such that, during use, when the tubular member is correctly positioned, the one or more regions are within a blood vessel. Each of the one or more regions may be located between the distal end and the proximal end of the tubular member. The one or more regions may be configured such that a medical device passes through the one or more regions and extends within the blood vessel in a direction opposite to the extension direction of the tubular member.

[0015] In various aspects, a device may be provided. The device may include a tubular member coupled to a proximal hub. The tubular member may include a first lumen extending from the proximal hub to a distal end and a second lumen extending from the proximal hub and exiting a side opening proximal to the distal end. The first opening in the proximal hub may be configured to slidably receive a first medical device, the first opening being operably coupled to the first lumen.

[0016] The second opening of the proximal hub may be configured to slidably receive a second medical device, the second opening being operably coupled to the second lumen. At least a portion of the second medical device may have a memory shape so that it returns to its normal shape upon exiting the side opening. In use, the side opening may be configured to be positioned within a blood vessel when the tubular member is correctly positioned. The tubular member may include an expandable sleeve through which the second medical device is inserted. The tubular member may be a catheter, cannula, or needle. A sheath and / or sleeve may be positioned over or around any needle.

[0017] BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the general description of the invention given above and the detailed description of the embodiments given below, serve to explain the principles of the invention. [Brief explanation of the drawings]

[0018] [Figure 1] 1 shows antegrade and retrograde sheaths inserted into the vasculature of a patient. [Figure 2] FIG. 1 is a diagram of one embodiment of a system. [Figure 3] FIG. 1 is a diagram of one embodiment of a system. [Figure 4] FIG. 1 is a diagram of one embodiment of a system. [Figure 5] FIG. 1 is a diagram of one embodiment of a system. [Figure 6] FIG. 1 is a diagram of one embodiment of a system. [Figure 7] FIG. 1 is a diagram of one embodiment of a system. [Figure 8] FIG. 1 is a diagram of one embodiment of a system. [Figure 9] FIG. 1 is a diagram of one embodiment of a system. [Figure 10] FIG. 1 is a diagram of one embodiment of a system. [Figure 11] FIG. 1 is a diagram of one embodiment of a system. [Figure 12] FIG. 1 is a diagram of one embodiment of a system. DETAILED DESCRIPTION OF THE INVENTION

[0019] It should be understood that the accompanying drawings are not necessarily to scale and present somewhat simplified representations of various features illustrating the underlying principles of the present invention. Specific design features of the sequence of operations as disclosed herein, including, for example, the specific dimensions, orientations, locations, and shapes of the various components shown, are determined, in part, by the particular intended application and use environment. Certain features of the illustrated embodiments have been enlarged or distorted relative to others to facilitate visualization and clear understanding. In particular, thin features may be thickened, for example, for clarity or illustration.

[0020] MODE FOR CARRYING OUT THE INVENTION The following description and drawings merely illustrate the principles of the present invention. Accordingly, it will be understood that those skilled in the art can devise various arrangements that embody the principles of the present invention and are within its scope, although not explicitly described or shown herein. Furthermore, all examples listed herein are expressly intended primarily for illustrative purposes only to aid the reader in understanding the principles of the present invention and the concepts provided by the inventors to advance the art, and should be construed as not being limited to such specifically listed examples and conditions. Furthermore, as used herein, the term "or" refers to a non-exclusive or (e.g., "or otherwise" or "or alternatively") unless otherwise indicated. Furthermore, the various embodiments described herein are not necessarily mutually exclusive, as some embodiments can be combined with one or more other embodiments to form new embodiments.

[0021] Many of the innovative teachings of the present application will be described with particular reference to presently preferred exemplary embodiments. However, it should be understood that this type of embodiment provides only a few examples of the many advantageous uses of the innovative teachings herein. In general, statements made in the specification of the present application do not necessarily limit any of the various claimed inventions. Moreover, some statements may apply to some inventive features but not to others. Those skilled in the art and informed by the teachings herein will understand that the present invention is applicable to a variety of other technical fields or embodiments.

[0022] For purposes of this disclosure, a "distal" element is the portion of the element located farthest from the clinician, and "proximal" is the portion of the element closest to the clinician. In the case of a sheath that is deployed inside a patient, the sheath end that is deployed inside the patient is the "distal" end, while the handle or end held by the clinician that is located outside the patient is the "proximal" end.

[0023] As will be appreciated, a sheath may be inserted into a patient's vasculature, such as the femoral artery, through an arteriotomy (i.e., an access site within an artery) to create an insertion pathway for a medical device, such as a pump assembly. A portion of the pump assembly may then be advanced into the artery through the inner lumen of an initial access sheath (also called an introducer sheath). As will be appreciated, the pump may be deployed through the introducer sheath, thereby remaining in place throughout the entire duration of support (e.g., in both the catheter lab and the ICU). In some embodiments, a repositioning sheath may be advanced into the arteriotomy over the pump assembly and remain with the patient for long-term access site management (e.g., hemostasis, pump stability).

[0024] As will be appreciated, the introducer sheath must be of sufficient diameter to accommodate an intravascular device, such as a blood pump. In some embodiments, the motor diameter of such pumps can be 12 Fr to 21 Fr or larger, depending on the type of device. In such embodiments, the sheath must be 13 to 22 Fr or larger, depending on the pump size.

[0025] During extracorporeal membrane oxygenation (ECMO) use, cannula devices are used to access the patient's vasculature, which is the conduit for blood pumped by the ECMO circuit either leaving or entering the body. These cannulae may be similar to introducer sheaths and may range in size from 13F to 30F, depending on the clinical application. Their diameter may also be restrictive to blood flow, similar to introducer sheaths.

[0026] While existing introducer sheaths generally work for device insertion, they have drawbacks. For example, due to their size, introducer sheaths can block the cross-sectional area of ​​the artery, thereby occluding the artery, which can severely restrict downstream blood flow. Restriction of blood flow can be problematic for many reasons, including causing limb ischemia, which can result in intermittent claudication, leg numbness / weakness, and even limb loss.

[0027] Limb ischemia is a rapid and sudden decrease in limb perfusion that often threatens the viability of the limb. This condition can occur as a result of blood choking by indwelling sheaths and / or catheters, local occlusion (e.g., atherosclerotic stenosis), and / or continuous occlusion by small vessels and / or large sheaths. It can also occur as a result of closure problems. Traditionally, limb ischemia is known as a "distal perfusion" problem, meaning it often occurs downstream from the device insertion site.

[0028] For relatively large medical devices (e.g., having a maximum outer diameter of 12 Fr or greater), the introducer sheath (or repositioning sheath) used in combination with the medical device may have an outer diameter substantially similar in size to the inner diameter of the artery or vessel in which the sheath is positioned. This match between the outer diameter of the sheath and the inner diameter of the artery or vessel prevents blood from flowing from a point upstream of the arteriotomy to a point downstream of the arteriotomy. Furthermore, for these relatively large medical devices, the introducer sheath (or repositioning sheath) used in combination with the medical device also requires a large access site that may be difficult to close or difficult to control bleeding when inserting or withdrawing the sheath. The size of the medical device (e.g., relatively large or relatively small), and therefore whether the introducer sheath or repositioning sheath is considered relatively large, may depend on the anatomy of a particular patient.

[0029] Other drawbacks include excessive bleeding at the arteriotomy site during sheath insertion or removal, which can result in blood loss and patient debilitation. This is typically treated by using closure devices such as collagen injections, sutures, or staples. However, these types of closure devices can be difficult to use when blood flow has not yet been adequately stopped and floods the access site while it is being closed. Furthermore, these types of closure devices generally require additional tools or steps and therefore require time to close effectively.

[0030] The size of the introducer sheath and its impact on the patient can be complicated by the patient's anatomy (e.g., severe stenosis and small vessels) and condition (e.g., patients with shock, vasospasm, or vasoconstriction due to vasopressors), which can limit the size of the introducer that can be used to gain access. In the case of vasospasm, even a sheath appropriately sized for the original vessel diameter will fill the entire constricted vessel. Thus, in some patients, a very small sheath, e.g., a 6 Fr, may be too large and lead to the same occlusion and access bleeding concerns as a 12 Fr sheath in another patient.

[0031] In general, the above drawbacks can be significant in long-term vascular procedures. Because certain procedures in the catheterization lab are short-term, the risks are low—for example, they typically require no more than 4–5 hours—and physicians regularly check distal (limb) perfusion. However, even in short-term situations, physicians may forget to ensure that patients are receiving adequate distal perfusion from the device or miss warning signs of inadequate limb perfusion. In addition, certain patients may be transferred to the ICU with introducer or repositioning sheaths remaining in the patient for longer periods, ranging from 1–14 days, potentially worsening the problems of vascular occlusion and associated limb ischemia, as well as access site bleeding.

[0032] To overcome the problems associated with conventional techniques, retrograde and antegrade cannulation are standard techniques. However, antegrade sheath placement can be challenging. While antegrade sheath placement is generally difficult and only select physicians possess the skill set to perform it, antegrade sheath placement after insertion of a large-bore sheath or cannula (such as Impella or ECMO) is even more challenging. In these clinical scenarios, blood flow is blocked by the sheath or cannula, and the device hub remains outside the skin. These issues make it difficult to identify the correct anatomical location of the artery by pulse (no blood flow means no pulse) or ultrasound (the device gets in the way, preventing easy use of the ultrasound probe).

[0033] It may be desirable to place an antegrade sheath even after inserting an intravascular device (e.g., an IMPELLA® heart pump) through a retrograde sheath. One challenge is that the retrograde sheath is typically in the way, but other difficulties include the need to use ultrasound to place it (because various medical devices have already been inserted), the need for the physician to switch hands to perform the insertion, and, even if successful, the potential for a "dead space" between the vascular entry site for the retrograde sheath and the vascular entry for the antegrade sheath.

[0034] This is illustrated in Figure 1, which shows a retrograde sheath 1 inserted into a first portion 2 of a patient's vasculature with a guidewire 3 passing through the sheath. An antegrade sheath 5 is shown inserted into a second portion 6 of the patient's vasculature. As can be seen, there is an obstruction 10 in the first portion of the patient's vasculature that prevents blood from flowing freely past the retrograde sheath. This, in turn, results in a dead zone 20 within the vasculature, which may form in some or all of the volume of the space within the vasculature between the antegrade and retrograde sheaths.

[0035] To improve upon these prior art techniques, various options have been considered by the inventors and are disclosed herein.

[0036] In some embodiments, features may be added to the hub to provide an insertion angle and / or needle angle that may allow for easier access to a blood vessel, such as the femoral artery. In some embodiments, a sheath may be provided that may include a distal cannula body and a proximal hub. The proximal hub may include a first opening at a distal end that extends to the proximal end and is operatively connected to the distal cannula body.

[0037] The cannulas described herein typically include a lumen extending from the distal end to the proximal end. In some embodiments, the cannula may be comprised of a coil of shape memory material, the coil disposed across the outer diameter of the inner layer. The cannula may further include an inner layer and a thermoformed outer layer disposed across the coil and extending along the length of the cannula. In certain implementations, the coil is embedded in the outer layer. In further embodiments, the shape memory material comprising the coil is at least one of nitinol or a copper-aluminum alloy. The outer layer of the cannula may include an outer material. In certain embodiments, the outer material may include polyurethane. In some implementations, the outer material may include Texin®. Texin is a thermoplastic polyurethane (TPU). In some implementations, the inner material may include polyurethane. In other implementations, the inner material may include Texin®. When polyurethane is used for the inner and / or outer layers, the polyurethane may include polyether or polyester. In certain implementations, the inner and outer materials may be the same.

[0038] The hubs described herein may include ethylene vinyl acetate (EVA), styrene butadiene copolymer (SBC), styrene ethylene butylene styrene (SEBS), high density polyethylene (HDPE) material, medium density polyethylene (MDPE) material, low density polyethylene (LDPE) material, polyether ether ketone (PEEK), polyether block amide, elastomer, synthetic rubber, polyethylene, polyurethane with a modulus of elasticity of about 40 ksi, or polycarbonate material, or combinations thereof. The hubs described herein may also include polyamide (nylon), acrylonitrile butadiene styrene (ABS), and / or polyether block amide (PEBA).

[0039] The proximal hub may also include a second opening at the distal end offset from the first opening and extending at least partially toward the proximal end, the second opening forming a hole, channel, or guide in the hub that points toward the blood vessel in which the cannula is positioned along a path that is offset and parallel to the distal cannula body to provide the blood vessel with a second entry point that is different from the entry point of the cannula.

[0040] An example of this can be seen in FIG. 2, which shows a sheath 100 with a distal cannula body 110 coupled to the distal end 121 of a proximal hub 120. The distal end 111 of the cannula body is positioned within a blood vessel 102 of a subject 104. The proximal hub can have a first opening 130 extending from the distal end to the proximal end, the first opening being operably coupled to the cannula body. In this manner, a medical device, such as an intravascular pump, can extend through the first opening, through the cannula body, and into the blood vessel in a first direction (e.g., toward the subject's heart). The proximal hub can include a second opening 140 extending at least partially from the distal end toward the proximal end. The second opening can be offset from the first opening. In some embodiments, a central axis 155 of the first opening is offset from a central axis 150 of the second opening by a predetermined distance 145. In some embodiments, the second opening extends entirely from the distal end to the proximal end. In some embodiments, the second opening may include, for example, a membrane or a hemostatic valve. In some embodiments, the first opening may have a larger diameter at the proximal end such that the second opening connects to the first opening in the proximal hub at a point between the distal and proximal ends.

[0041] In some embodiments, the second opening may form a hole, channel, or guide in the hub that points toward the blood vessel along a path (such as a linear path extending along the central axis 150 of the second opening) to target a second entry point 160 that is different from the distal cannula body entry point 112. This second entry point may allow, for example, a second cannula to extend through the second opening and through the second entry point and be directed into the blood vessel in a second direction that is different from the first direction (e.g., away from the subject's heart).

[0042] In some embodiments, the path is substantially parallel to the proximal end 115 of the cannula body. In some embodiments, the path is parallel to the central axis 155 of the first opening.

[0043] Alternatively, referring to FIG. 3 , rather than a guide or channel extending through the hub, in some embodiments, an accessory 200 (e.g., an add-on) may be provided to access the second entry point. The accessory may be configured to attach to the proximal end 115 of the distal cannula body 110 or to a proximal hub 205 coupled to the cannula body. The accessory may include a separate cannula body 210 operably coupled to the distal cannula body 110 or the proximal hub 205. For example, the add-on may be clamped, snapped, glued, or otherwise coupled to the distal cannula body or the proximal hub. The separate cannula body may be configured to point toward the vessel along a path 220 (e.g., a linear path) to target the second entry point 160. In still other embodiments, rather than a separate cannula body for providing such access to the second entry point, the distal cannula body may have a larger diameter at the proximal end than at the distal end, and the proximal end includes a lumen that does not extend the entire length of the distal cannula body.

[0044] In some embodiments, the accessory may be removably coupled to the distal cannula body and / or the proximal hub. In some embodiments, the accessory add-ons may be permanently coupled to the distal cannula body and / or the proximal hub.

[0045] Referring to FIG. 4 , in some embodiments, a device 300 may be provided having a proximal hub 310 coupled to a cannula body 320. In such embodiments, the device may include an adjustable portion 330 that includes the distal end of the proximal hub and / or the proximal end 323 of the cannula body. In some embodiments, the adjustable portion is located within the distal end of the proximal hub. In some embodiments, the adjustable portion is coupled between the distal end of the proximal hub and the proximal end of the cannula body. In some embodiments, the adjustable portion may include an articulation joint, such as a flexible and adjustable ball joint. The adjustable portion may allow for only one-dimensional rotation (e.g., rotation in a single plane) or two-dimensional rotation.

[0046] In some embodiments, the distal end 321 of the cannula body may be oriented to point in a proximal direction. For example, the cannula body may be curved so that the distal end is parallel to the central portion 322 but oriented 180 degrees in the opposite direction. In some embodiments, after the 180-degree bend, the outer surface of the distal end 321 is spaced a distance 340 of 0.25 to 1 mm from the outer surface of the central portion. As will be appreciated, such a device may allow a physician flexibility in the direction in which access to a patient's vasculature is achieved.

[0047] Referring to FIG. 5, in some embodiments, an introducer sheath 400 (sometimes referred to as an "introducer" or "introducer sheath") may be configured for multiple access to the vasculature. As shown in this figure, the sheath 400 may include a tubular body 410. The tubular body 410 may include a first lumen 412 providing a first pathway extending from the proximal end of the tubular body to the distal end of the tubular body. The distal end of the tubular body may be configured to create a micropuncture in the blood vessel. In some embodiments, the distal end of the tubular body is configured to have an outer diameter of 21 Fr or less.

[0048] The tubular body may include a proximal portion 420 that defines a second lumen 422 that extends from the proximal end of the tubular body and provides a second pathway extending distally. The second lumen may have an opening 424 at the distal end of the proximal portion that is configured to be positioned outside of the blood vessel into which the first lumen is inserted. A curved needle or wire 455 may be configured to be slidably received by the second lumen to allow it to enter the blood vessel at a point different from the point where the first lumen enters the blood vessel.

[0049] The introducer may include a hub 430 that may include one or more luer connections. In some embodiments, the hub may include two luer connections, one operably coupled to each lumen in the tubular body. The hub may include a first opening 432 configured to be coupled to the proximal end of the first lumen. The hub may also include a second opening 434 configured to be coupled to the proximal end of the second lumen. The first opening may be configured to slidably receive one or more medical devices configured to be inserted in a first direction (e.g., retrograde), and the second opening may be configured to slidably receive one or more medical devices configured to be inserted in a second direction (e.g., antegrade) different from the first direction. In some embodiments, wires 450, 455 may be inserted retrogradely and / or antegradely through the appropriate lumens.

[0050] The needle tip is configured to puncture the blood vessel 102. In some embodiments, a second device 520 may be inserted into the catheter 500 after the needle is removed. As shown in FIG. 6C, the distal end of the second device may be configured to point in a first direction (e.g., antegrade), while another device (e.g., guidewire 450) is inserted in a second direction (e.g., retrograde).

[0051] In some embodiments, a large needle may be used with one or more tubular members to provide access to the vasculature. As shown in FIGS. 6A-6C, a catheter 500 having a hub 501 coupled to a distal tubular member 502 may be configured to slidably receive a large needle 510. The large needle may include a hub 511, or handle portion, and a distal needle tip 512 configured to extend through the catheter. Separately, a second device 520 may be provided, which includes a proximal hub 521 coupled to a proximal end 523 of the distal tubular member 522, which may include a distal tip 525 that is curved to point in a different direction than a central portion 524 of the distal tubular member 522. The distal tip may have a fixed or variable separation distance from the central portion.

[0052] It will be appreciated that instead of using two devices, a single assembled device can be utilized, where the introducer tip can be curved to an antegrade position once the needle is removed. For example, instead of using a micropuncture introducer (e.g., as shown in FIG. 6A) along with a second device (shown in FIG. 6B) into the catheter, the single assembled device can have a catheter similar in shape to catheter 520 (FIG. 6B). The needle (e.g., see 511 / 512) can be pre-assembled onto the catheter to straighten the tip for the user, allowing the user direct access using the assembly. Once access is achieved, the needle may be removed, and the catheter tip will be curved in the antegrade direction. The user can then place a guidewire antegradely through the catheter.

[0053] In some embodiments, a dual needle may be provided as a device for puncturing a blood vessel at multiple locations (see FIG. 7). One of the two needles may be usable to provide an access point for an antegrade sheath, and one of the two needles may be usable to provide an access point for a retrograde sheath. Referring to FIG. 7, a device 600 may be provided that includes a first needle 610. The first needle may define a lumen 613 extending from a distal end 611 to a proximal end 612. The first needle may have a first length 615, the length being from the distal end to the proximal end.

[0054] The device may include a second needle 620. The second needle may define a lumen 623 extending from a distal end 621 to a proximal end 622. The second needle may have a second length 625, which is the length from the distal end to the proximal end. The second length may be shorter than the first length. As will be appreciated, the first and second needles may have any suitable lengths in other embodiments.

[0055] The outer surface of the first needle may be separated from the outer surface of the second needle by a distance 626 .

[0056] Each needle may be connected to a proximal hub 630 or handle. The proximal hub or handle may include a first opening 632 extending from the proximal end to the distal end of the hub and configured to be operably coupled to a lumen in the first needle. The proximal hub or handle may include a second opening 634 extending from the proximal end to the distal end of the hub and configured to be operably coupled to a lumen in the second needle. The openings and lumens may be configured to allow one or more medical devices (e.g., guidewires, etc.) to pass through the openings, pass through the lumens, and enter the blood vessel.

[0057] In some embodiments, a needle having two lumens may be provided as an alternative or in combination with other devices disclosed herein. Referring to FIG. 8 , a cross section of a needle may be shown. The needle 700 may include one or more side walls 705 that may define two lumens 710, 720 extending from the proximal end 701 toward the distal end 702 of the needle. The first lumen 710 may extend from the proximal end to the distal end and exit through an opening 707 at the distal end of the needle. The second lumen 720 may extend from the proximal end but not all the way to the distal end. Rather, it passes through the side wall at an intermediate portion 703 of the needle between the distal and proximal ends and exits through the side wall at a second opening 706. The second opening 706 should be positioned sufficiently close to the distal end so that the second opening will be positioned within a blood vessel during use.

[0058] Using such a configuration, antegrade and retrograde access can be provided through a single needle stick using a single access point (eg, the same arteriotomy).

[0059] 9, in some embodiments, the device may operably couple two lumens to one another, for example, to access a blood vessel without pressure. This may allow, for example, blood to flow into the distal end of the first lumen and out the distal end of the second lumen into the blood vessel. Similarly, this may allow the wire to be directed in a secondary direction. As will be appreciated, this may be used with devices having two lumens, including, for example, a dual-lumen needle.

[0060] As seen in FIG. 9 , device 800 may include a hub 810 coupled to at least one tubular member 815 defining a first lumen 820 and a second lumen 830, the tubular members extending distally away from the hub. The hub may include one or more valves 811, 812, and first lumen 820 may be configured to slidably receive a medical device passing through any of the valves. As shown, the hub may include a predetermined volume of space 813 coupled to both lumens, such that a pathway 850 from the distal opening of the first lumen to the distal opening of the second lumen can be formed by passing through the predetermined volume of space. Preferably, the first lumen is configured so that excess space exists within the first lumen after the medical device is inserted to allow, for example, blood or wires to pass outside the medical device.

[0061] In some embodiments, an inverted needle may be provided. For purposes of this specification, an inverted needle refers to a needle configured to be inserted in a first direction (e.g., retrograde) but with a single exit point of the needle facing a second direction (e.g., antegrade). Referring to FIG. 10, one embodiment of such a device may be shown. The inverted needle 900 may include one or more side walls 905 defining a lumen 910 extending from a proximal end 901 toward a distal end 902. The first lumen, similar to the second lumen shown in FIG. 8, is shaped to exit through an opening 906 in the side (rather than the end) of the needle. As will be appreciated, in such embodiments, the lumen may include a contact surface 920 that may orient the needle in a first direction (e.g., toward the distal end 902) and then move the needle in a second direction (e.g., away from the distal end) toward the side wall opening 906.

[0062] In some embodiments, a puncturable tubular member (such as a sheath) may be provided. For example, as shown in FIG. 11 , a tubular member 1010 may have a proximal end coupled to a distal end of a proximal hub 1020. The tubular member may have one or more regions 1060 (but not the entire region) of the tubular member that may be puncturable (e.g., by the distal end of a medical device). In some embodiments, the puncturable region may be free of a reinforcing coil. The puncturable region may also have a thinner sidewall thickness than the sidewall thickness at different locations. The puncturable region may further be laser cut and then filled, for example, with a polymer. In some embodiments, the polymer forming the puncturable region may be different from the polymer forming the sidewall at different locations. The puncturable region may have other suitable configurations in other embodiments.

[0063] The puncturable region may be within a portion 1015 of the tubular member such that, in use, when the tubular member is correctly positioned, the puncturable region is within a blood vessel. In some embodiments, this portion 1015 may be located between the distal and proximal ends of the tubular member.

[0064] The puncturable region may be configured so that an additional medical device 1050 (e.g., a cannula, wire, etc.) can be slidably received by the hub and passed through the opening 1030 in the hub into the tubular member, and the distal end 1055 of the additional medical device may be configured to pass through the puncturable region and extend in the opposite direction within the blood vessel compared to the direction in which the tubular member extends (e.g., extend antegradely when the tubular member extends antegradely).

[0065] Referring to FIG. 12 , in some embodiments, a device may be provided where tubular member 1110 may be coupled to proximal hub 1120. The tubular member may include two lumens. A first lumen 1112 may extend from the hub to a distal end 1111. A second lumen 1113 may extend from the hub and exit through a side opening. As shown, a medical device may be slidably received through a first opening 1122 in the hub operably connected to the first lumen. A second medical device (e.g., a guidewire, needle, etc.) may be slidably received through a second opening 1124 in the hub operably connected to the second lumen. At least a portion 1145 of the second medical device may have a memory shape such that it returns to its shape, e.g., a J-shape, upon exiting the opening through the side wall of the tubular member.

[0066] In some embodiments, the device can be configured such that, in use, when the tubular member is correctly positioned, the opening through the side wall is positioned within the blood vessel.

[0067] In some embodiments, the tubular member can include an expandable sleeve, for example a polymeric sleeve, through which a second medical device can be inserted.

[0068] In various embodiments, the tubular member may be a catheter, a cannula, or a needle.

[0069] In some embodiments, a sheath and / or sleeve may be provided over or around any needle.

[0070] During insertion using a needle and catheter, if the patient's blood backs up, the physician may advance the catheter. The physician may then attach a guidewire, which may be used, for example, with or for a kink-resistant sheath.

[0071] Dual-lumen embodiments allow for one lumen to be used to provide retrograde access and one lumen to provide antegrade access. When providing antegrade access, in some embodiments, the lumens may be shaped or configured to reduce resistance to changes in direction required for such insertion. For example, sharp bends are typically less preferable than more gentle curves or bends.

[0072] In some embodiments, various embodiments may include one or more attachments for the needle. For example, in some embodiments, a clutch may be provided that applies a spring force / tension forward so that the guidewire drops slightly forward if there is free space, e.g., upon entry into a vessel with a guidewire including a needle. This may be used in constricted vessels (e.g., in limbs that are already ischemic). Such attachments may facilitate access and feedback for proper placement without the use of ultrasound. In some embodiments, such attachments may be used with a probe rather than a wire.

[0073] Various modifications may be made to the systems, methods, devices, mechanisms, techniques, and portions thereof described herein with respect to the various figures, and such modifications are considered to be within the scope of the present invention. For example, while a particular order of steps or arrangement of functional elements is presented in various embodiments described herein, various other orders / arrangements of steps or functional elements may be utilized within the context of various embodiments. Furthermore, while modifications to embodiments may be discussed individually, various embodiments may employ multiple modifications simultaneously or sequentially, combined modifications, etc.

[0074] While various embodiments incorporating the teachings of the present invention have been shown and described in detail herein, those skilled in the art can readily devise many other various embodiments which still incorporate these teachings. Thus, while the foregoing is directed to various embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof.

Claims

1. A retrograde sheath, a hub including a first opening extending from a proximal end to a distal end of the hub and a second opening extending from the proximal end to the distal end of the hub; a first cannula coupled to a distal end of a hub, the first opening being operably coupled to the first cannula; and Including, retrograde sheath.

2. The retrograde sheath of claim 1 , wherein the second opening comprises a membrane or a hemostatic valve.

3. 2. The retrograde sheath of claim 1, wherein the first opening has a larger diameter at the proximal end such that the second opening connects with the first opening in the hub at a point between the distal end and the proximal end.

4. The retrograde sheath of claim 1 , wherein the first opening is configured to be directed toward a blood vessel and the second opening is configured to be directed toward the blood vessel.

5. 5. The retrograde sheath of claim 4, wherein the first cannula is configured to be oriented into the blood vessel in a first direction and the second cannula is configured to be oriented into the blood vessel in a second direction different from the first direction.

6. 2. The retrograde sheath of claim 1, wherein the first cannula has a larger diameter at a proximal end than at a distal end, the proximal end including a first lumen extending a first length toward the distal end and a second lumen parallel to the first lumen extending a distance toward the distal end less than the first length.

7. A retrograde sheath, a hub including a first opening extending from a proximal end to a distal end of the hub; a distal cannula having a distal cannula body coupled to a distal end of a hub, the first opening being operably coupled to the distal cannula; an accessory coupled to the proximal end of the distal cannula body or to the hub, the accessory including a separate cannula body; Including, retrograde sheath.

8. The retrograde sheath of claim 7 , wherein the distal cannula is configured to be directed toward a blood vessel and the separate cannula body is configured to point toward the blood vessel.

9. The retrograde sheath of claim 8 , wherein the attachment is removably coupled to the distal cannula body or the hub.

10. The retrograde sheath of claim 8 , wherein the attachment is permanently attached to the distal cannula body or the hub.

11. A retrograde sheath, A proximal hub coupled to the cannula body Including, The retrograde sheath includes an adjustable portion, the adjustable portion including a distal end of the proximal hub and / or a proximal end of the cannula body.

12. The retrograde sheath of claim 11 , wherein the adjustable portion is located within the distal end of the proximal hub.

13. The retrograde sheath of claim 11 , wherein the adjustable portion is coupled between the distal end of the proximal hub and the proximal end of the cannula body.

14. The retrograde sheath of claim 11 , wherein the adjustable portion includes an articulation joint.

15. The retrograde sheath of claim 11 , wherein the adjustable portion is configured to allow rotation in only one dimension.

16. The retrograde sheath of claim 11 , wherein the adjustable portion is configured to allow rotation in only one dimension or in two dimensions.

17. The retrograde sheath of claim 11 , wherein the distal end of the cannula body is oriented to face proximally.

18. 12. The retrograde sheath of claim 11, wherein the outer surface of the distal end of the cannula body is spaced from the outer surface of the central portion of the cannula body by a distance of 0.25 to 1 mm after being bent 180 degrees.

19. an introducer sheath, a tubular body including a first lumen providing a first pathway extending from a proximal end of the tubular body to a distal end of the tubular body; an introducer sheath.

20. The introducer sheath of claim 19, wherein the distal end of the tubular body is configured to create a micropuncture in a blood vessel.

21. 20. The introducer sheath of claim 19, wherein the distal end of the tubular body is configured to have an outer diameter of 21 Fr or less.

22. 20. The introducer sheath of claim 19, wherein the tubular body includes a proximal portion defining a second lumen extending from the proximal end of the tubular body and providing a distally extending second passageway.

23. 23. The introducer sheath of claim 22, wherein the second lumen has an opening at a distal end of the proximal portion configured to be positioned outside a blood vessel into which the first lumen is inserted.

24. 24. The introducer sheath of claim 23, wherein the second lumen is configured to slidably receive a curved needle or wire such that the second lumen may enter the blood vessel at a location different from the location where the first lumen enters the blood vessel.

25. The introducer sheath of claim 19, further comprising a hub operably coupled to the tubular body.

26. The introducer sheath of claim 25, wherein the hub includes a luer connection.

27. 27. The introducer sheath of claim 26, wherein the hub includes one luer connection operably coupled to each lumen in the tubular body.

28. The introducer sheath of claim 25, wherein the hub includes a first opening configured to be coupled to a proximal end of the first lumen.

29. The introducer sheath of claim 28, wherein the hub includes a second opening configured to be coupled to a proximal end of a second lumen.

30. 30. The introducer sheath of claim 29, wherein the first opening is configured to slidably receive one or more medical devices configured to be inserted into a blood vessel in a first direction, and the second opening is configured to slidably receive one or more medical devices configured to be inserted into the blood vessel in a second direction different from the first direction.

31. 1. A system comprising: a needle operably coupled to a hub or handle; a device including a proximal hub coupled to a proximal end of a distal tubular member, the device including a distal tip curved to point in a different direction than a central portion of the distal tubular member; a catheter having a hub coupled to a distal tubular member, the hub configured to slidably receive the needle and, after the needle is removed, to slidably receive the device; Including, the system.

32. 32. The system of claim 31, wherein the needle is configured to puncture a blood vessel at multiple locations.

33. 32. The system of claim 31, wherein the distal tip has a constant separation distance from the central portion.

34. 32. The system of claim 31, wherein the distal tip has a variable separation distance from the central portion.

35. 32. The system of claim 31, wherein the needle is a twin needle.

36. 36. The system of claim 35, wherein a first needle of the twin needles is configured to provide an access point for an antegrade sheath and a second needle of the twin needles is configured to provide an access point for a retrograde sheath.

37. A device, a first needle defining a first lumen extending from a distal end to a proximal end of the first needle and having a first length from the distal end to the proximal end; a second needle defining a second lumen extending from a distal end to a proximal end of the second needle and having a second length from the distal end to the proximal end; a proximal hub, the first needle and the second needle connected to the proximal hub, the proximal hub having a first opening and a second opening, each opening extending from a proximal end to a distal end of the proximal hub, the first opening operably coupled to the first lumen, and the second opening operably coupled to the second lumen; Including, the device.

38. 38. The device of claim 37, wherein the first length is greater than the second length.

39. 38. The device of claim 37, wherein the first length is equal to the second length.

40. 38. The device of claim 37, wherein each opening and lumen is configured to slidably receive one or more medical devices.

41. A needle, a sidewall defining a first lumen extending from the proximal end to the distal end of the needle and a second lumen extending from the proximal end to an outlet in an intermediate portion of the sidewall, the outlet being configured to be a predetermined distance from the distal end of the needle such that both the distal end and the outlet are positioned within a blood vessel in use; Including needles.

42. A device, a hub coupled to at least one tubular member defining a first lumen and a second lumen, the at least one tubular member extending distally away from the hub, the first lumen configured to slidably receive a medical device; one or more valves disposed within the hub; Including, A device wherein the hub defines a space of a predetermined volume coupled to the first lumen and the second lumen, whereby a pathway from a distal opening of the first lumen to a distal opening of the second lumen can be formed by passing through the space of the predetermined volume.

43. 43. The device of claim 42, wherein the first lumen is configured such that there is extra space within the first lumen after a medical device is inserted.

44. It is an inverted needle, one or more side walls defining a lumen extending from the proximal end toward the distal end of the inverted needle, the lumen being configured to exit through an opening in a side of the inverted needle proximal to the distal end; Including, inverted needles.

45. A device, a tubular member having a proximal end coupled to a distal end of a proximal hub, the tubular member having one or more areas pierceable by the distal end of a medical device that are less than the total area of ​​the tubular member; Including, the device.

46. 46. ​​The device of claim 45, wherein the one or more regions are free of reinforcing coils.

47. 46. ​​The device of claim 45, wherein the one or more regions have a sidewall thickness that is thinner than the sidewall thickness at different locations.

48. 46. ​​The device of claim 45, wherein the one or more regions are laser cut and then filled with a filler material.

49. 49. The device of claim 48, wherein the filler material is a polymer.

50. 49. The device of claim 48, wherein the filler material is different from the polymer that forms the sidewalls in different locations.

51. 46. ​​The device of claim 45, wherein the one or more regions are within a portion of the tubular member such that, in use, when the tubular member is correctly positioned, the one or more regions are within a blood vessel.

52. 46. ​​The device of claim 45, wherein each of the one or more regions is located between a distal end and a proximal end of the tubular member.

53. 46. ​​The device of claim 45, wherein the one or more regions are configured to allow a medical device to pass through the one or more regions and extend in an opposite direction within the blood vessel relative to the direction in which the tubular member extends.

54. A device, a tubular member coupled to a proximal hub, the tubular member including a first lumen extending from the proximal hub to a distal end, and a second lumen extending from the proximal hub and exiting a side opening proximal to the distal end; Including, the device.

55. 55. The device of claim 54, wherein a first opening in the proximal hub is configured to slidably receive a first medical device, the first opening being operably coupled to the first lumen.

56. 56. The device of claim 55, wherein a second opening in the proximal hub is configured to slidably receive a second medical device, the second opening being operably coupled to the second lumen.

57. 57. The device of claim 56, wherein at least a portion of the second medical device has a memory shape such that the second medical device returns to its normal shape when the second medical device exits the side opening.

58. 55. The device of claim 54, wherein, in use, the side opening is configured to be positioned within a blood vessel when the tubular member is correctly positioned.

59. 55. The device of claim 54, wherein the tubular member includes an expandable sleeve into which a second medical device is inserted.

60. 55. The device of claim 54, wherein the tubular member is a catheter, cannula, or needle.

61. 61. The device of claim 60, wherein the sheath and / or sleeve may be placed over or around any needle.

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