Apparatus and method for use of a perforated introducer - Patent Application 20070122997

Abstract

The present invention provides an introducer. The introducer includes an introducer body having longitudinally spaced apart proximal and distal introducer ends. The introducer body has laterally spaced apart inner and outer introducer walls. The inner introducer wall defines an introducer lumen. At least one aperture extends laterally through the introducer body between the inner and outer introducer walls to fluidly connect the introducer lumen to the ambient space.

Description

Detailed Description of the Invention

[0001] (Related Applications) This application claims priority to U.S. Provisional Application No. 63 / 413,270, filed October 5, 2022, the entirety of which is incorporated herein by reference for all purposes.

[0002] The present technology is related to a U.S. patent application by Kenneth McCurry et al., entitled "Apparatus and Method for Use with Fluid Flow Devices," published January 19, 2023, and having publication number 2023 / 0019859 (hereinafter referred to as the "'859 publication"), the entire text of which is incorporated herein by reference for all purposes. [Technical Field]

[0003] The present invention relates to devices and methods for the use of a perforated introducer, and more particularly to methods and perforated introducer devices for use in extracorporeal membrane oxygenation. [Background technology]

[0004] Extracorporeal membrane oxygenation (ECMO), also known as extracorporeal life support, is an extracorporeal technique that provides long-term cardiac and / or respiratory support to people whose hearts and / or lungs cannot provide sufficient gas exchange and / or irrigation to sustain life. For example, ECMO can be provided to patients during or after major surgical procedures to help reduce the patient's own body's burden of oxygenating blood due to cardiac or pulmonary dysfunction, or both.

[0005] In ECMO, deoxygenated blood is removed from a patient's body vascular system through one lumen of a device, infused with oxygen gas and / or treated with other therapeutic methods, and then returned to the patient's vascular system (through a different lumen of the same device or a different device). Examples of ECMO systems and related devices are taught in the '859 publication, among others.

[0006] 1-2 illustrate a conventional ECMO cannula unit 100 (which may be the cannula unit taught in the above-mentioned '859 publication) configured for use within a patient's heart. In FIG. 1, the ECMO cannula unit 100 is configured to facilitate fluid exchange via the patient's right atrium ("RA"). In FIG. 2, the ECMO cannula unit is configured to facilitate fluid exchange via the patient's pulmonary artery ("PA"). In both figures, the cannula device 100 may be used to remove fluid from a patient's vasculature and simultaneously or sequentially return fluid to the patient's vasculature. An outer sheath 102 is inserted into a target removal site within the patient. An infusion cannula 104 may be at least partially retained within the outer sheath 102 for simultaneous insertion. Alternatively, the infusion cannula 104 may not be retained within the outer sheath 102 until the outer sheath 102 is deployed as needed. Once the outer sheath 102 is positioned at the target removal site, the infusion cannula 104 may be inserted (or further inserted) distally into the outer sheath 102, preferably using an introducer, until the distal infusion cannula end extends from the side of the outer sheath 102 and enters the bore, resulting in the configuration shown in Figures 1-2. The fluid return port 106 is positioned at the target return site within the patient's vasculature. The outer sheath 102 may then remove fluid from the target removal site (e.g., via the fluid removal port 108), and the infusion cannula 104 may return fluid to the target return site sequentially and / or simultaneously as needed.

[0007] Both the outer sheath 102 and the infusion cannula 104 are in at least partial fluid communication with an ECMO circuit outside the patient's body (shown schematically as an ECMO processor at 110) to provide for desired treatment, such as oxygenating blood removed from the body by the outer sheath 102 before returning it to the infusion cannula 104.

[0008] 3-4 schematically illustrate a prior art introducer 112. The introducer 112 allows the infusion cannula 104 to be positioned in the patient's vasculature, preferably via a guidewire 114. As shown in FIG. 3, when the introducer 112 is positioned within the infusion cannula 104 via an x-tip line, the introducer 112 prevents blood flow ("BF") supplied from the ECMO processor 110 to the infusion cannula 104 from passing through the infusion cannula 104. This prevents the prior art ECMO cannula unit 100 from being repositioned using the introducer 112 from the RA outlet position in FIG. 1 to the PA outlet position in FIG. 2 while still allowing blood to be infused into the patient's vasculature via the infusion cannula 104 via the ECMO circuit. Conversely, prior art cannula movement techniques require interruption of the ECMO blood supply to the patient when moving the infusion cannula 104, which may be detrimental to the patient's health in some cases. Summary of the Invention

[0009] In one aspect, an introducer is described. The introducer body has longitudinally spaced proximal and distal introducer ends. The introducer body has laterally spaced inner and outer introducer walls. The inner introducer wall defines an introducer lumen. At least one hole extends laterally through the introducer body between the inner and outer introducer walls to fluidly connect the introducer lumen to an ambient space.

[0010] For a better understanding, reference can be made to the drawings. [Brief explanation of the drawings]

[0011] [Figure 1] FIG. 1 is a schematic side view of a conventional ECMO device in a first use condition. [Figure 2] FIG. 1 is a schematic side view of a conventional ECMO device in a second use condition. [Figure 3] FIG. 3 is a schematic side view of a prior art introducer that can be used with the ECMO device of FIGS. 1-2. [Figure 4] 4 is a schematic side view of the prior art introducer of FIG. 3 in an exemplary environment of use. [Figure 5] 1 is a schematic side view of an introducer according to a first embodiment of the present invention. FIG. [Figure 5A] FIG. 6 is a cross-sectional view taken along line AA in FIG. 5. [Figure 6] 6 is a schematic side view of the introducer of FIG. 5 in an exemplary environment of use. [Figure 7] FIG. 2 is a schematic side view of an introducer according to a second embodiment of the present invention. [Figure 8] 8 is a schematic side view of the introducer of FIG. 7 in an exemplary environment of use. [Figure 9] FIG. 10 is a schematic side view of an introducer according to a third embodiment of the present invention. [Figure 10] 10 is a schematic side view of the introducer of FIG. 9 in an exemplary environment of use. DETAILED DESCRIPTION OF THE INVENTION

[0012] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0013] As used herein, the term "subject," while interchangeable with the term "patient," refers to any warm-blooded living organism, including, but not limited to, humans, pigs, rats, mice, dogs, goats, sheep, horses, monkeys, apes, rabbits, cows, farm animals, livestock, and the like.

[0014] As used herein, the singular forms "a", "an" and "said" may include the plural forms unless the context clearly dictates otherwise. It will be further understood that as used herein, the terms "comprise" and / or "include" may specify the presence of stated features, steps, operations, elements and / or units, but do not exclude the presence or addition of one or more other features, steps, operations, elements, units and / or combinations thereof.

[0015] As used herein, the term "and / or" may include any and all combinations of one or more of the associated items.

[0016] When an element is referred to as being "on," "attached to," "connected to," "coupled," "contacting," or "adjacent" another element, it should be understood that the element can be directly located on, attached to, connected to, coupled to, contacting, or adjacent to another element, or that intermediate elements may be present. In contrast, when an element is referred to as being "directly on," "directly attached to," "directly connected to," "directly coupled to," "directly in contact with," or "directly adjacent to" another element, for example, there are no intermediate elements present. As will be understood by those skilled in the art, a description of a structure or feature positioned "directly adjacent" to another feature may have portions that overlap or underlie the adjacent feature, and a structure or feature positioned "adjacent" to another feature may not have portions that overlap or underlie the adjacent feature.

[0017] For ease of description, spatially relative terms such as "lower," "below," "down," "upper," "top," "proximal," and "distal" may be used herein to describe the relationship of one element or feature illustrated in the figures to one or more other elements or features. As will be understood, in addition to the orientation depicted in the figures, the spatially relative terms can also include different orientations in use or operation of the device. For example, if the device in the figures were inverted, an element described as "below" or "below" another element or feature would be oriented so that it would be "above" the other element or feature.

[0018] As used herein, the phrase "at least one of X and Y" can be interpreted to include X, Y, or a combination of X and Y. For example, if an element is described as having at least one of X and Y, the element can include X, Y, or a combination of X and Y at a particular time, and the selection for X, Y, or X and Y can change over time. In contrast, the phrase "at least one of X" can be interpreted to include one or more Xs.

[0019] As can be understood, the terms "first," "second," etc. may be used to describe various elements herein, but these elements should not be limited to these terms. These terms are used to distinguish one element from another. Thus, a "first" element discussed below may also be referred to as a "second" element without departing from the meaning of the present invention. Unless otherwise specified, the order of operations (or steps) is not limited to the order shown in the claims or figures.

[0020] The invention comprises, consists of or consists essentially of the following features in any combination:

[0021] 5-10 are schematic diagrams illustrating an introducer 500 that cooperates to guide an infusion cannula 502 for desired navigation within a patient's vasculature. While the patient's vasculature is used here as an example of an environment of use, the introducer 500 and / or infusion cannula 502 of the present invention can be configured for use with any desired environment of use (e.g., cerebrospinal fluid, ECMO (including pulmonary artery infusion), ECLS, right ventricular assist or RVAD, wound drainage and flushing, renal dialysis, peritoneal drainage and flushing, fluid transfer and removal, and other medical and / or non-medical applications).

[0022] As shown in FIG. 5 , the introducer 500 includes an introducer body 504 having longitudinally spaced apart proximal and distal introducer ends 506 and 508. As used herein, the "longitudinal direction" is generally parallel to the arrow "L" in FIG. 5 and corresponds to the direction of insertion of the introducer 500 into a patient. The cross-sectional view of FIG. 5A illustrates a portion of the introducer body 504 as having laterally spaced apart inner and outer introducer walls 510 and 512. As used herein, the "lateral direction" is generally perpendicular to the longitudinal direction and lies essentially in the plane of the page of FIG. 5A . The inner introducer wall 512 defines an introducer lumen 514.

[0023] At least one hole 516 extends laterally through the introducer body 504 between the introducer inner wall 510 and the introducer outer wall 512, thereby fluidly connecting the introducer lumen 514 to the environmental space (designated "A" in FIG. 5A ). That is, the at least one hole 516 allows fluid to flow laterally between the introducer lumen 514 and the environmental space A. The hole 516 may be of any suitable configuration and location on the introducer body 504, depending on the needs of a particular use of the introducer 100. For example, one skilled in the art can readily provide one or more holes 516 having any desired size, shape, wall arrangement (e.g., tapering outward from the introducer lumen 514), location on the introducer body 504, degree of coverage of the introducer body 504, alignment with other holes 516, and / or any other physical property, and any one of the holes 516 may have at least one physical property that is different from any one or more of the other holes 516.

[0024] An introducer coupler, shown schematically at 518, may be located at the proximal introducer end 506 and may connect the introducer 500 to any other desired components and / or may be a separate handle to assist a user in manipulating the introducer 500. If present, the introducer coupler 518 may be a hub with a seal and / or a hemostatic valve configured to prevent blood from flowing back out of the introducer coupler 518.

[0025] The introducer body 504 may taper inward from the center near the distal introducer end 508, forming a nosecone, as shown. If present, this tapered "nose cone" shape may be sized and shaped to provide a smooth distal transition for the infusion cannula 502 and to taper toward the tip to accommodate the diameter of a guidewire or small catheter inserted through the introducer 500, thereby facilitating easier tracking and guidance of the introducer 500 within the patient.

[0026] 6 illustrates introducer 500 ready for placement within a patient (or illustrating movement / adjustment of introducer 500's position if it is already in place). At least a portion of introducer 500 is inserted within infusion cannula 502. Introducer 500 and infusion cannula 502 may comprise at least part of a system for maintaining blood flow in the ECMO circuit when repositioning at least a portion of the system (i.e., fluid need not be blocked from flowing through infusion cannula 502, facilitating use of introducer 500). Accordingly, infusion cannula 502 may include proximal and distal cannula ends 520 and 522 longitudinally spaced apart by a cannula body 524 that defines cannula lumen 526. Optionally, introducer 500 is configured to pass at least a portion of cannula lumen 536. 6, fluid communication between the proximal cannula end 520 and the distal introducer end 508 via / through the cannula lumen 536 is maintained, at least in part, by at least one aperture 516 and the introducer lumen 514. In other words, blood flow in the figure, as indicated by arrows BF, may be guided from the ECMO processor 110 (previously removed from the patient's body and processed) to the proximal cannula end 530. Here, the blood enters the introducer lumen 514 via one or more apertures 516 adjacent the proximal introducer end 506. The blood then travels through the introducer lumen 514 and away from the one or more apertures 516 adjacent the distal introducer end 508, thereby maintaining blood flow from the ECMO circuit into the patient's vasculature as the introducer 500 assists in moving the infusion cannula 502. The introducer 500 may be configured to assemble tightly enough within the cannula lumen 526. In this manner, any holes 516 located within the cannula lumen 526 are effectively blocked, thereby favoring longitudinal blood flow out of the distal cannula end 522 before the majority of the blood passes through the holes 516 and away from the introducer lumen 514.

[0027] The introducer lumen 514 may further be configured to selectively receive at least a portion of a guidewire 528 passing completely longitudinally therethrough. For example, as shown at least in FIG. 6 , the system may include a guidewire 528. The guidewire 528 is configured to be selectively inserted at least partially through the introducer lumen 514 from the proximal introducer end 506 and into a distal bore 530 located at the distal introducer end 508. The distal bore 530 may extend generally coaxially with the introducer lumen 514 and be configured to selectively receive at least a portion of the guidewire 528 passing longitudinally therethrough. In this manner, when the introducer 500 is at least partially positioned within the infusion cannula 502, a “straight shot” is created for a user to assist in moving the infusion cannula 502 with the guidewire 528 in a known manner.

[0028] Preferably, for example, if it is desired to separate the guidewire 528 from the blood flow, the guidewire lumen 532 may be defined within the introducer lumen 514 by a guidewire tube (preferably shown in dashed lines at 534), at least a portion of which extends longitudinally through the introducer lumen 514.

[0029] The infusion cannula 502 may include a bifurcated coupler (generally designated 536; the coupler may be integral to the infusion cannula 502 or may be provided separately) located at the proximal cannula end 520. The bifurcated coupler 536, if present, may include a first coupler branch 538 configured to selectively fluidly connect to the ECMO process machine 110 that supplies blood to the infusion cannula 502. The bifurcated coupler 536 may include a second coupler branch 540 configured to selectively allow entry of the introducer body 504 (e.g., entry at an angle to one side of the infusion cannula 502). The first coupler branch 538 and the second coupler branch 540 meet within the cannula lumen 526 at the distal-most side of the bifurcated coupler 536. As shown, the introducer 500 is sufficiently flexible to enter the second coupler branch 540 and then curve along the cannula lumen 526, thereby supporting the structure of the infusion cannula 502 and guiding it for movement within the body.

[0030] In particular, if the introducer 500 and infusion cannula 502 are used in an ECMO procedure or any other filtration or fluid treatment procedure, the removed fluid may be therapeutically treated (e.g., oxygenated and / or filtered) after being removed from the vascular system via the infusion cannula 502 and before being returned to the vascular system. If desired, therapeutic devices with any suitable connectors may be provided to and / or used with the introducer 500 and infusion cannula 502.

[0031] 5, at least one of the holes 516 may comprise a void in a repeating grid pattern formed by the introducer body 504. Although not shown to scale in the drawings, the holes 516 are not limited to being located at predetermined locations along the introducer body 504, and the hole placement in FIG. 5 is exemplary of a repeating void / grid pattern placement.

[0032] More generally, the description "grid pattern" may be one specific, non-limiting example of an introducer 500 configuration. The plurality of holes 516 are spaced apart from one another but are collectively positioned along most (substantially the entire) length (longitudinal) of the introducer body 504. Other configurations of the one or more holes 516 may be used for the introducer 500 and are readily provided by those skilled in the art for specific environments of use. Two other specific, non-limiting examples of introducer 500 configurations are discussed in more detail below with reference to FIGS. 7-10. However, it should be noted again that the drawings herein are substantially schematic and not drawn to scale.

[0033] Regardless, and as shown, the plurality of holes 516 may be spaced apart longitudinally along the introducer body 504. Direct or indirect fluid communication from a fluid source (e.g., the ECMO processor 110, as shown) into the introducer lumen 514 may be provided by a first subset of the plurality of holes 516 located in a first region of the introducer 500. As shown, the first subset of the plurality of holes 516 is located in an area adjacent the proximal introducer end 506, but where inflow is not substantially blocked by lateral proximity of the inner wall of the infusion cannula 502. Once a fluid flow (herein designated blood flow BF) has entered the introducer lumen 514 via a first subset of holes 516, a second subset of holes 516 can provide fluid communication from the introducer lumen 514 to environmental space A (where, at least initially, it enters longitudinally along a region spaced from the distal infusion cannula end 522), where the second subset of holes 516 is located in a second region of the introducer 500 and spaced longitudinally from the first region. As shown, the second subset of holes 516 is located in a region adjacent the distal introducer end 508, but is not substantially blocked by, for example, lateral proximity of the inner wall of the infusion cannula 502. The second subset of holes may also be located in a portion of the introducer body 504 that protrudes distally from the distal infusion cannula end 522.

[0034] FIGS. 7-8 illustrate a second embodiment of an introducer 500'. Because the introducer 500' of FIGS. 7-8 is similar to the introducer 500 of FIGS. 5-6, structures in FIGS. 7-8 that are the same as or similar to structures described in FIGS. 5-6 have the same reference numerals followed by a prime symbol. Descriptions of common elements and operations similar to elements and operations in the first embodiment described above are not repeated in the second embodiment and are deemed incorporated herein by appropriate reference. For clarity, many of the reference numerals used to designate structures similar to those in FIGS. 5-6 have been omitted in FIGS. 7-8.

[0035] In the introducer 500' shown in FIGS. 7-8, the first plurality of holes 516' (generally designated "1A") are located near the proximal introducer end 506', and the second plurality of holes 516' (generally designated "2A") are located near the distal introducer end 508'. A central portion (generally designated "C") of the introducer body 504' is located longitudinally between the first plurality of holes 1A and the second plurality of holes 2A and does not include holes, i.e., does not have holes 516'. In some use environments, the central portion C may comprise at least half of the entire longitudinal length of the introducer body 504'. However, it should be noted that the drawings herein are not drawn to scale. Additionally, in some use environments, one of the first hole 1A and the second hole 2A may be used to allow blood (e.g., blood from the ECMO treatment machine 110) to enter the introducer lumen 514′, and the blood may then travel (e.g., along blood flow arrow BF) through the other of the first hole 1A and the second hole 2A and away from the introducer lumen 514 (e.g., to reach environmental space A).

[0036] 7-8, the holes 516' are positioned toward the distal introducer end 508' and the proximal introducer end 506' to help provide rigidity to the introducer 500' structure while still maintaining blood flow in and out of the introducer lumen 514' during repositioning of the infusion cannula 502'. The holes 516' may have essentially the same size and distribution density at appropriate locations adjacent the proximal introducer end 506' and the distal introducer end 508' and may be configured to help achieve the required fluid dynamics (e.g., large holes in some areas and small holes in other areas).

[0037] FIGS. 9-10 illustrate a third embodiment of an introducer 500″. Because the introducer 500″ of FIGS. 9-10 is similar to the introducer 500 and introducer 500′ of FIGS. 5-8, structures in FIGS. 9-10 that are the same as or similar to structures described in FIGS. 5-8 are designated with the same reference numerals followed by a double prime symbol. Descriptions of common elements and operations similar to elements and operations in the first and second embodiments described above are not repeated in the third embodiment and are deemed to be incorporated herein by appropriate reference. For clarity, many of the reference numerals used to designate structures similar to those in FIGS. 5-8 have been omitted in FIGS. 9-10.

[0038] In the introducer 500'' shown in FIGS. 7-8, the plurality of holes 516'' are arranged at multiple locations along the introducer body 504''. That is, there are multiple holes 516'', with a single hole 516'' located at one of multiple locations along the introducer body 504''. The average location density of the plurality of holes 516'' adjacent the proximal introducer end 506'' and / or the distal introducer end 508'' is greater than the average location density of the plurality of holes 516'' at a center (generally designated "C") of the introducer body 504''. The center C comprises at least half of the entire longitudinal length of the introducer body 504''. In other words, the holes 516'' adjacent one or both of the proximal introducer end 506'' and the distal introducer end 508'' may be more closely ``clustered'' than the holes 516'' ``clustered'' at the center C of the introducer body 504''. When arranged in such a ``clustering'' of holes 516'', one skilled in the art can easily configure the introducer 500'' as needed for a particular use environment.

[0039] As with any of the embodiments of introducer 500, 500′, and 500″, the introducer 500″ shown in FIGS. 9-10 may include at least one selected bore 516S. The selected bore 516S may have a size and / or profile that is different from the size and / or profile of at least one other bore 516″. For example, the selected bore 516S may have a larger cross-sectional area than at least one of the other bores 516″. In FIGS. 9-10, the selected bore 516S is configured to serve as a cannula bore 516S adjacent the proximal introducer end 506″. When at least a portion of the introducer 500″ is inserted through the cannula lumen 526″, the cannula bore 516S is located near the proximal cannula end 520″, as shown in FIG. 10. When present, cannula bore 516S is configured to provide fluid communication between introducer lumen 514'' and cannula lumen 526'' in a direction extending generally coaxially with cannula lumen 526''. That is, cannula bore 514'' may be generally aligned with cannula lumen 526'' as shown in FIG. 10 , particularly when introducer 500'' is curved to enter cannula lumen 526'' through branch coupler 536'' (which may be integral to or separately provided on infusion cannula 502'').

[0040] The above-referenced methods may be performed to maintain blood flow through the ECMO processor 110 while repositioning at least a portion of the ECMO circuit (wherein any embodiment of introducer 500, 500′, 500″ is used to reposition the infusion cannula 502). A guidewire 528 may optionally be inserted at least partially through the proximal introducer end 506, through the introducer lumen 514, and into a distal hole 530 located at the distal introducer end 508. The introducer 500 may be threaded at least partially through the cannula lumen 526, preferably using a bifurcated coupler 536 or other structure to assist in “side-loading” the introducer 500 onto the infusion cannula 502. By allowing blood flow through at least one hole 516 and the introducer lumen 514, fluid communication between the proximal cannula end 520 and the distal introducer end 508 can be maintained at least in part by the cannula lumen 526.

[0041] While various aspects of the present invention have been particularly shown and described with reference to the above exemplary embodiments, various other aspects are contemplated, as will be understood by those skilled in the art. For example, the specific method of using the above-described device is exemplary. Those skilled in the art can readily determine any number of tools, step sequences, or other means / options to position the device or its components in essentially similar locations to those shown herein. To maintain clarity in the figures, some duplicated parts are not specifically numbered; however, those skilled in the art will recognize the part numbers that should be associated with unnumbered parts based on the numbered parts. The presence or absence of part numbers in the figures does not imply a distinction between similar parts. Any of the structures and components may form a single, entire component or may be composed of individual subcomponents, any of which may be any suitable stock or customized component and / or any suitable material or combination of materials. However, the materials selected should be biocompatible for many applications. Any of the structures and components may be disposable or reusable, thereby meeting the needs of a particular use environment. Any component may be provided with a user-perceptible marking that may indicate material, configuration, at least one size, or the like associated with the component, and the user-perceptible marking may assist the user in selecting one component for a particular use environment from an array of similar components. The term "substantially" is used herein to indicate a large degree of quality, but not necessarily all of the quality. It is recognized that "substantially" quality may include relatively minor non-quality items. While some components described herein are shown as having particular geometric shapes, all structures of the present invention may have any suitable shape, size, configuration, relative relationship, cross-sectional area, or any other physical characteristic preferred for a particular application.Any structure or feature described with reference to one aspect or configuration may be provided alone or in combination with other structures or features in any other aspect or configuration, and it is not practical to describe each aspect and configuration described herein as every option described in connection with every other aspect and configuration. Apparatus or methods incorporating any one of these features should be understood to fall within the scope of the invention, as determined by the following claims and any equivalents thereof.

[0042] Other aspects, goals and advantages can be obtained from a study of the drawings, the disclosure and the appended claims.

Claims

1. an introducer, an introducer body and at least one hole; the introducer body having longitudinally spaced apart proximal and distal introducer ends, the introducer body having laterally spaced apart inner and outer introducer walls, the inner introducer wall defining an introducer lumen; The at least one hole extends laterally through the introducer body between the introducer inner wall and the introducer outer wall, thereby fluidly connecting the introducer lumen to an ambient space.

2. The introducer of claim 1 , wherein the introducer includes an introducer coupler located at the proximal introducer end.

3. The introducer of claim 2, wherein the introducer coupler is a hub having at least one of a sealing material and a hemostatic valve, and the introducer coupler is configured to prevent blood from flowing back from outside the introducer coupler.

4. The introducer of claim 1 , wherein the at least one aperture comprises a plurality of spaced apart apertures, the plurality of apertures collectively disposed along substantially the entire length of the introducer body.

5. 2. The introducer of claim 1, wherein the at least one hole includes a plurality of first holes adjacent the proximal introducer end and a plurality of second holes adjacent the distal introducer end, a center portion of the introducer body is located longitudinally between the first and second holes, the center portion does not include any holes, and the center portion comprises at least half of the entire longitudinal length of the introducer body.

6. 2. The introducer of claim 1, wherein the at least one hole comprises a plurality of holes located at a plurality of positions along the introducer body, and wherein an average location density of the plurality of holes adjacent at least one of the proximal introducer end and the distal introducer end is greater than an average location density of the plurality of holes located at a center portion of the introducer body, the center portion comprising at least half of the entire longitudinal length of the introducer body.

7. 10. The introducer of claim 1, wherein the at least one aperture comprises a plurality of apertures, and at least one selected aperture differs in at least one of size and contour from at least one other aperture.

8. The introducer of claim 1 , wherein the introducer body tapers inward from a center near the distal introducer end to form a nosecone.

9. The introducer of claim 1 , wherein the introducer lumen is configured to selectively receive at least a portion of a guidewire passing completely longitudinally therethrough.

10. The introducer of claim 9 , wherein the introducer lumen has a guidewire lumen defined at least in part by a guidewire tube passing longitudinally therethrough.

11. The introducer of claim 1 , wherein the introducer includes a distal hole located at the distal introducer end and extending coaxially with the introducer lumen.

12. The introducer of claim 11 , wherein the distal hole is configured to selectively receive at least a portion of a guidewire longitudinally therethrough.

13. The introducer of claim 1 , wherein the at least one hole comprises a void in a repeating grid pattern formed by the introducer body.

14. 1. A system for maintaining blood flow in an extracorporeal membrane oxygenation (ECMO) circuit when repositioning at least a portion of the system, comprising: an infusion cannula having proximal and distal cannula ends longitudinally spaced apart by a cannula body defining a cannula lumen; and the introducer of claim 1 , the introducer is configured to be selectively inserted at least partially into the cannula lumen; The system, wherein fluid communication between the proximal cannula end and the distal introducer end via the cannula lumen is maintained at least in part by the at least one hole and the introducer lumen.

15. 15. The system of claim 14, wherein the system includes a guidewire selectively inserted at least partially from the proximal introducer end through the introducer lumen and into a distal hole located at the distal introducer end.

16. 15. The system of claim 14, wherein the at least one hole is a plurality of holes spaced apart longitudinally along the introducer body, wherein fluid communication from the ambient space into the introducer lumen is provided by a first subset of the plurality of holes located in a first region of the introducer, and fluid communication from the introducer lumen to the ambient space is provided by a second subset of the plurality of holes located in a second region of the introducer, the second region being spaced apart longitudinally from the first region.

17. 15. The system of claim 14, wherein the introducer includes a cannula lumen adjacent a proximal introducer end, the cannula lumen positioned adjacent the proximal sleeve end when at least a portion of the introducer is inserted into the cannula lumen, the cannula lumen configured to provide fluid communication between the introducer lumen and the cannula lumen substantially coaxial with the cannula lumen.

18. 15. The system of claim 14, wherein the infusion cannula includes a branched coupler located at a proximal end thereof, the branched coupler including a first coupler branch configured to be selectively fluidly connected to an ECMO processor that supplies blood to the infusion cannula, and the branched coupler including a second coupler branch configured to selectively accept entry of the introducer body, the first coupler branch and the second coupler branch meeting within the cannula lumen at a distal-most side of the branched coupler.

19. 1. A method of maintaining blood flow in an extracorporeal membrane oxygenation (ECMO) circuit when repositioning at least a portion of the ECMO circuit, comprising: providing an infusion cannula having proximal and distal cannula ends longitudinally spaced apart by a cannula body defining a cannula lumen; Providing an introducer according to claim 1; selectively inserting at least a portion of the introducer into the cannula lumen; and at least partially maintaining fluid communication between the proximal cannula end and the distal introducer end via the cannula lumen via the at least one hole and the introducer lumen.

20. 20. The method of claim 19, comprising selectively inserting at least a portion of a guidewire from the proximal introducer end, through the introducer lumen, and into a distal hole located at the distal introducer end.

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