Adjustable-size extracorporeal life support cannula

Abstract

A cannula (100) for an extracorporeal life support system may include a tubular element (110) and an actuation structure (140). The actuation structure (140) may be configured to be sensitive to an external stimulus such that an internal diameter of the tubular element (110) changes when the external stimulus changes. A system may include the cannula (100) and a control device (30) in electrical communication with the actuation structure (140). The control device may be configured by a user to set a desired value for an internal diameter of the tubular element (110). Figure for the abstract: Fig. 1

Description

Description Title of the invention: EX- LIFE SUPPORT CANNULA TRACORPORAL WITH ADJUSTABLE DIMENSIONS

[0001] TECHNICAL FIELD The present invention relates generally to life support systems. extracorporeal life support (“ECLS” for “Extra Corporeal Life Support” in English) and / or veno-arterial extracorporeal membrane oxygenation ("VA ECMO" for "Veno-Arterial Extra Corporeal Membrane Oxygenation" in English). More particu- Specifically, the present disclosure relates to a cannula for use with a extracorporeal life support (ECLS) and / or membrane oxygenation system veno-arterial extracorporeal mooring (VA ECMO). TECHNOLOGICAL BACKGROUND

[0002] — Extracorporeal membrane oxygenation (ECLS) and / or veno- arterial (VA ECMO) can draw blood from the circulatory system, ty- prick in the right atrium, pump blood through an external oxygenator, then return blood to the arterial circulation via the pulmonary artery or artery femoral. These systems are useful for treating patients with insufficiency right ventricular failure, respiratory failure, or both. In some systems and / or applications, multiple single-lumen cannulas are required. In some systems and / or applications, a double-lumen cannula may be used.

[0003] Patients receiving ECLS and / or VA ECMO may experience significant variety of anatomies and / or sizes. Due to the wide range of anatomies, there is no no "one size fits all" cannula. Hospitals and / or suppliers must stock many cannulas of the same type in many sizes to better suit to the patient's needs. In some cases, the size of the vascular system is not always known before the procedure, so an incorrectly sized cannula may be used and must then be discarded and replaced when the mismatch is discovered.

[0004] There is a continuing need for ECLS and / or VA ECMO devices, components and / or methods of using and / or manufacturing as a variant of these devices positives and / or components. SUMMARY

[0005] An example of a cannula for an extracorporeal life support system comprises a tubular element formed from a polymeric material and having a lumen extending from a proximal end to a distal end and a structure ac- actionable structure incorporated into the polymer material. The actionable structure is configured to be responsive to an external stimulus such that an internal diameter of the tubular element changes when the external stimulus changes. Additionally or alternatively to any example described herein, the tubular member is an inner tubular member of a double-lumen cannula. Additionally or alternatively to any example described herein, the tubular member is an outer tubular member of a double-lumen cannula. Additionally or alternatively to any example described herein, the actuatable structure comprises a shape memory material. Additionally or alternatively to any example described herein, the tubular member includes a proximal portion having a first outer diameter and a distal portion having a second outer diameter less than the first outer diameter. Additionally or alternatively to any example described herein, the actuatable structure is disposed within the distal portion of the tubular member. Additionally or alternatively to any example described herein, the actuatable structure extends proximally from the distal end of the tubular member. Additionally or alternatively to any example described herein, the actuatable structure is configured to be responsive to one of: an applied voltage, a temperature, and a light. Additionally or alternatively to any example described herein, the external stimulus is an applied voltage. Additionally or alternatively to any example described herein, the external stimulus is a temperature. Additionally or alternatively to any example described herein, the external stimulus is a light. Another illustrative example is a system for use with an extracorporeal life support system. The system includes a cannula including a tubular member defining a lumen, an actuatable structure attached to the tubular member, and a controller in electrical communication with the actuatable structure. The actuatable structure is configured to be responsive to a voltage applied from the controller such that an inner diameter of the tubular member changes when the applied voltage changes. The controller is configurable by a user to set a desired value for an inner diameter of the tubular member.The controller includes a known correlation between the inner diameter of the tubular member and the applied voltage, and the controller is configured to send the applied voltage to the actuatable structure to change the inner diameter of the tubular member to the desired value for the inner diameter. Additionally or alternatively to any example described herein, the inner diameter of the tubular member may be enlarged in situ. Additionally or alternatively to any example described herein, the internal diameter of the tubular member may be decreased in situ. Additionally or alternatively to any example described herein, the inner diameter of a distal portion of the tubular member is adjustable between about 2 mm and about 10.7 mm. Additionally or alternatively to any example described herein, a portion of the tubular member is devoid of the actuatable structure. Additionally or alternatively to any example described herein, the portion of the tubular member lacking the actuatable structure is configured to be disposed outside of a patient's body. Another illustrative embodiment is a method of connecting a patient's vasculature to an extracorporeal life support system. The method includes advancing a delivery sheath into the patient's vasculature. The delivery sheath has a cannula including a tubular member defining a lumen and an actuatable structure attached to the tubular member disposed therein. The method further includes moving the delivery sheath relative to the cannula to expose the cannula within the patient's vasculature, and changing the actuatable structure from a first configuration to a second configuration while at least a portion of the cannula is disposed within the patient's vasculature to change an inner diameter of the tubular member. Additionally or alternatively to any example described herein, shifting the actuatable structure includes applying an external stimulus to the actuatable structure. Additionally or alternatively to any example described herein, the external stimulus is applied by a control device in electrical communication with the actuatable structure. Additionally or alternatively to any example described herein, the method further comprises the step of removing the delivery sheath, and fluidly connecting the cannula to the extracorporeal life support system. The above summary of certain embodiments, aspects and / or examples is not intended to describe every embodiment or implementation of the present disclosure. The following figures and detailed description more particularly illustrate these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS The disclosure may be more fully understood by considering the description detailed below in relation to the attached drawings, in which: [Fig. 1] schematically illustrates selected aspects of a system and cannula for use with an extracorporeal life support system; [Fig.2A] is a cross-sectional view illustrating selected aspects of the cannula of [Fig.1] configured as a single-lumen cannula; [Fig.2B] is a cross-sectional view illustrating selected aspects of the cannula of [Fig.1] configured as a double-lumen cannula; [Fig.3] schematically illustrates a selected aspect of the cannula of [Fig.1]; [Fig.4] schematically illustrates a selected aspect of the cannula of [Fig.1]; [Fig.5] schematically illustrates a selected aspect of the cannula of [Fig.1]; [Fig.6] schematically illustrates a selected aspect of the cannula of [Fig.1]; [Fig.7] schematically illustrates a selected aspect of the cannula of [Fig.1]; [Fig.8] schematically illustrates a selected aspect of the cannula of [Fig.1]; [Fig.9] schematically illustrates a selected aspect of the cannula of [Fig.1]; [Fig.10] illustrates a selected aspect of an actuatable structure according to the disclosure; [Fig.10A] illustrates a selected aspect of an actuatable structure according to the disclosure; [Fig.10B] illustrates a selected aspect of an actuatable structure according to the disclosure; [Fig. 11] illustrates a selected aspect of an actuatable structure according to the disclosure; [Fig.11A] illustrates a selected aspect of an actuatable structure according to the disclosure; [Fig.11B] illustrates a selected aspect of an actuatable structure according to the disclosure; [Fig.12] illustrates a selected aspect of an actuatable structure according to the disclosure; [Fig.12A] illustrates a selected aspect of an actuatable structure according to the disclosure; [Fig.12B] illustrates a selected aspect of an actuatable structure according to the disclosure; and [Fig. 13] is a partially broken away view illustrating selected aspects relating to a method of using the system and cannula of [Fig. 1]. Although aspects of the invention are subject to various modifications and variations, details thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that it is not the intention to limit aspects of the disclosure to the particular embodiments described. Rather, the intent is to cover all modifications, equivalents, and variations within the spirit and scope of the disclosure. DETAILED DESCRIPTION The following description should be read with reference to the drawings, which are not necessarily to scale, in which like reference numerals indicate like elements throughout the several views. The detailed description and the drawings are intended to illustrate exemplary embodiments of the disclosure, but not to limit the disclosure. Those skilled in the art will recognize that the various elements described and / or shown may be arranged in various combinations and configurations without departing from the scope of the disclosure. For the terms defined below, these definitions shall apply, unless a different definition is given elsewhere in this description. All numerical values ​​herein are intended to be modified by the term "about," whether or not explicitly stated. The term "about," in the context of numerical values, generally refers to a range of numbers that one skilled in the art would consider equivalent to the cited value (e.g., having the same function or result). In many cases, the term "about" may include numbers that are rounded to the nearest significant digit. Other uses of the term "about" (e.g., in a context other than numerical values) may be assumed to have their ordinary and customary definition(s), as understood and consistent with the context of the specification, unless otherwise indicated. Reciting numeric ranges by endpoints includes all numbers in that range, including the endpoints (e.g., 1 to S includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although certain suitable dimensions, ranges and / or values ​​relating to various components, features and / or specifications are disclosed, those skilled in the art, induced by the present disclosure, will understand that the desired dimensions, ranges and / or values ​​may deviate from those expressly disclosed. As used in this specification, the singular forms "a," "an," and "the" include multiple referents unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in its meaning including "and / or" unless the content clearly indicates otherwise. It should be noted that for ease of understanding, certain features of the disclosure may be described in the singular, even though these features may be plural or recurring in the disclosed embodiment(s). Each instance of the features may include and / or be encompassed by the singular disclosure(s), unless expressly indicated otherwise. For reasons of For the sake of simplicity and clarity, not all elements of the invention are necessarily shown in each figure or described in detail below. However, it will be understood that the following discussion may apply equally to any and / or all components for which there is more than one, unless explicitly stated otherwise. Relative terms such as "proximal," "distal," "advance," "retraction," variations thereof, and the like may generally be considered with respect to the positioning, direction, and / or operation of various elements relative to a user / operator / manipulator of the device, with "proximal" and "retraction" indicating or referring to closer to or toward the user and "distal" and "advance" indicating or referring to farther or a greater distance from the user. In some instances, the terms "proximal" and "distal" may be arbitrarily assigned in an effort to facilitate understanding of the disclosure, and such instances will be readily apparent to the skilled artisan.Other related terms, such as "upstream," "downstream," "inflow," and "outflow," refer to a direction of fluid flow within a lumen, such as a body lumen, a blood vessel, or within a device. Other related terms, such as "axial," "circumferential," "longitudinal," "lateral," "radial," etc. and / or variations thereof generally refer to the direction and / or orientation relative to a central longitudinal axis of the disclosed structure or device. The terms "monolithic" and "unitary" generally refer to one or more elements consisting of a single basic structure or unit / element. A monolithic and / or unitary element excludes structures and / or elements manufactured by assembling or otherwise joining several separate structures or elements. It should be noted that references in the description to "an embodiment", "some embodiments", "other embodiments", etc., indicate that the described embodiment(s) may include a particular feature, structure or attribute, but that each embodiment may not necessarily include the particular feature, structure or attribute. Furthermore, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure or attribute is described in connection with one embodiment, one skilled in the art will know to assign the particular feature, structure or attribute in connection with other embodiments, whether or not explicitly described, unless otherwise clearly indicated.That is, the various individual elements described below, even if not explicitly shown in a particular combination, are nevertheless considered to be capable of being combined or arranged with each other to form other additional embodiments or to supplement and / or enrich. the described embodiment(s), as would be understood by those skilled in the art. For the sake of clarity, certain identifying numerical nomenclature (e.g., first, second, third, fourth, etc.) may be used throughout the specification to name and / or differentiate various described features. It should be understood that the numerical nomenclature is not intended to be limiting and is only exemplary. In certain embodiments, modifications and deviations from the previously used numerical nomenclature may be made for the sake of brevity and clarity. In other words, a feature identified as a “first” element may be later referred to as a “second” element, a “third” element, etc. or may be omitted entirely, and / or a different feature may be referred to as the “first” element. The meaning and / or designation in each instance will be obvious to those skilled in the art. As used herein, the term "at least one of" is synonymous with "one or more of," and these terms may be used interchangeably. For example, the term "at least one of A, B, and C" means any one of A, B, and C, or any combination of any two or more of A, B, and C. For example, "at least one of A, B, and C" includes one or more A alone; or one or more B alone; or one or more C alone; or one or more A and one or more B; or one or more A and one or more C; or one or more B and one or more C; or one or more of all of A, B, and C. Similarly, as used herein, the term "at least two of" is synonymous with "two or more of." For example, the term "at least two of D, E, and F" means any combination of any two or more of D, E, and F.For example, “at least two of D, E and F” includes one or more Ds and one or more Es; or one or more Ds and one or more Fs; or one or more Es and one or more Fs; or one or more of all of D, E and F. Further, in a given figure, certain features may not be shown, or may be shown schematically, for clarity and / or simplicity. Additional details regarding certain components and / or method steps may be illustrated in more detail in other figures. The devices and / or methods described herein may provide a number of desirable features and advantages as described in more detail below. [Fig. 1] schematically illustrates selected aspects of an extracorporeal life support (ECLS) system 20. In some embodiments, the system may include a cannula 100 including a tubular member 110 defining a lumen extending from a proximal end to a distal end. The ECLS system 20 may be configured to be fluidly connected to the cannula 100 and / or the tubular member 110. In some embodiments, the system may optionally include a delivery sheath 10 having a lumen extending therein. The cannula 100 and / or the tubular member 110 may optionally be slidably received within the lumen of the delivery sheath 10. In at least some embodiments, the tubular member 110 may be formed from a polymeric material. In some embodiments, the tubular member 110 may include a distal end that is open, having an opening extending into a lumen of the tubular member 110. In some embodiments, the tubular member 110 may include a distal end that is closed. In some embodiments, the tubular member 110 may include a first plurality of openings 120 extending through a wall of the tubular member 110 proximate and / or adjacent the distal end, which are in fluid communication with a lumen of the tubular member 110.In some embodiments, the tubular member 110 may include a second plurality of openings 130 extending through the wall of the tubular member 110 proximate the first plurality of openings 120 that are in fluid communication with a lumen of the tubular member 110. The second plurality of openings 130 may be in communication with the same lumen as the first plurality of openings 120, or the second plurality of openings 130 may be in fluid communication with a lumen different from the lumen with which the first plurality of openings are in fluid communication. In some embodiments, a thickness of the wall of the tubular member | LO may be substantially fixed and / or may remain substantially constant. In some embodiments, the system and / or the cannula 100 may include an actuatable structure 140 attached (e.g., fixedly attached, fixedly secured, adhered, formed with, embedded in, etc.) to the tubular member 110. In some embodiments, the actuatable structure 140 may be attached (e.g., fixedly attached, fixedly secured, adhered, formed with, embedded in, etc.) to an exterior surface of the tubular member 110. In some embodiments, the actuatable structure 140 may be attached (e.g., fixedly attached, fixedly secured, adhered, formed with, embedded in, etc.) to an interior surface of the tubular member 110. In some embodiments, the actuatable structure 140 may be at least partially embedded in the tubular member 110 and / or the polymeric material.In some embodiments, the actuatable structure 140 may be completely incorporated into the tubular member 110 and / or the polymeric material. Other configurations are also contemplated. Certain configurations of the actuatable structure 140 are described in more detail herein. In some embodiments, the tubular member 110 may include a proximal portion 112 having a first outer diameter and / or a first inner diameter, and a distal portion 114 having a second outer diameter and / or a second inner diameter. In some embodiments, the second outer diameter may be less than the first outer diameter. In some embodiments, the second inner diameter may be less than the first inner diameter. Other configurations are also contemplated. In some embodiments, the tubular member (110) may be tapered between the proximal portion (112) and the distal portion (114) such that the first outer diameter is tapered radially inward in a direction distal to the second outer diameter and / or the first inner diameter is tapered radially inward in a direction distal to the second inner diameter.Other configurations are also being considered. In some embodiments, a portion of the length of the tubular member 110 may be devoid of the actuatable structure 140. In some embodiments, the portion of the length of the tubular member 110 devoid of the actuatable structure 140 may be configured to be disposed outside of a patient's body. In some embodiments, the portion of the length of the tubular member 110 lacking the actuatable structure 140 may be the proximal portion 112. In some embodiments, the actuatable structure 140 may be disposed along and / or within the distal portion 114 of the tubular member 110 configured for insertion into a patient's body. In some embodiments, the actuatable structure 140 may extend proximally from the distal end of the tubular member 110 along a distal end region of the tubular member 110.In some embodiments, the portion of the length of the tubular member 110 lacking the actuatable structure 140 may be the distal portion 114. In some embodiments, the actuatable structure 140 may be disposed along and / or within the proximal portion 112 of the tubular member 110. In some embodiments, the actuatable structure 140 may be disposed along and / or within at least a portion of the distal portion 114 and may be disposed along and / or within at least a portion of the proximal portion 112 of the tubular member 110. In some embodiments, the actuatable structure 140 may be disposed along and / or within at least a portion of the distal portion 114 and may be disposed along and / or within at least a portion of the proximal portion 112 of the tubular member 110. Other configurations are also envisaged. In some embodiments, the actuatable structure 140 may be configured to transition from a first configuration to a second configuration. In some embodiments, the first configuration may be a distribution configuration and the second configuration may be a deployed configuration. In some embodiments, the actuatable structure 140 may be responsive to an external stimulus such that the inner diameter and / or outer diameter of the tubular member 110 changes when the external stimulus changes. In some embodiments, the actuatable structure 140 may be configured to transition from the first configuration and / or the dispensing configuration to the second configuration and / or the deployed configuration in response to the external stimulus. In some embodiments, the actuatable structure 140 may comprise a shape memory material (e.g., a shape memory alloy, a shape memory polymer, etc.). In some embodiments, the external stimulus may be an applied voltage. In some embodiments, the external stimulus may be a temperature.In some embodiments, the voltage and / or current applied within the actuatable structure 140 may cause a temperature change within the actuatable structure 140. In some embodiments, the external stimulus may be a light. Other configurations and / or stimuli are also contemplated. In some embodiments, the system may include a controller 30 in electrical communication with the actuatable structure 140. In some embodiments, the controller 30 may be configurable by a user to set or select a desired value for an inner diameter of the tubular member 110. In some embodiments, the controller 30 may be configurable by a user to set or select a first desired value for the first inner diameter of the tubular member 110. In some embodiments, the controller 30 may be configurable by a user to set or select a second desired value for the second inner diameter of the tubular member 110.In some embodiments, the controller 30 may be configurable by a user to set or select a first desired value for the first inner diameter of the tubular member 110 and a second desired value for the second inner diameter of the tubular member 110. Other configurations are also contemplated. In some embodiments, the actuatable structure 140 may be responsive to a voltage applied from the controller 30 such that the actuatable structure 140 transitions from the first configuration and / or the dispensing configuration to the second configuration and / or the deployed configuration. In some embodiments, the actuatable structure 140 may be responsive to the voltage applied from the controller 30 such that the inner diameter of the tubular member 110 changes when the applied voltage changes. The controller 30 may be configured to send the applied voltage to the actuatable structure 140 to change the inner diameter of the tubular member 110 to the desired value for the inner diameter. As described herein, in some embodiments, the inner diameter of the tubular member 110 may be enlarged in situ and / or the inner diameter of the tubular member 110 may be decreased in situ. In some embodiments, the controller 30 and / or the desired value for the inner diameter may be changed during the procedure and / or while the cannula 100 and / or the tubular member 110 are disposed in situ. In some embodiments, the actuatable structure 140 may be responsive to voltage applied from the controller 30 such that the first inner diameter of the tubular member 110 changes when the applied voltage changes. The controller 30 may be configured to send the applied voltage to the actuatable structure 140 to change the first inner diameter of the tubular member 110 to the first desired value for the first inner diameter. As described herein, in some embodiments, the first inner diameter of the tubular member 110 may be enlarged in situ and / or the first inner diameter of the tubular member 110 may be decreased in situ. In some embodiments, the controller 30 and / or the first desired value for the first inner diameter may be changed during the procedure and / or while the cannula 100 and / or the tubular member 110 are disposed in situ. In some embodiments, the actuatable structure 140 may be responsive to voltage applied from the controller 30 such that the second inner diameter of the tubular member 110 changes when the applied voltage changes. The controller 30 may be configured to send the applied voltage to the actuatable structure 140 to change the second inner diameter of the tubular member 110 to the second desired value for the second inner diameter. As described herein, in some embodiments, the second inner diameter of the tubular member 110 may be enlarged in situ and / or the second inner diameter of the tubular member 110 may be decreased in situ. In some embodiments, the controller 30 and / or the second desired value for the second inner diameter may be changed during the procedure and / or while the cannula 100 and / or the tubular member 110 are disposed in situ. In some embodiments, the inner diameter of the distal portion 114 of the tubular member 110 and / or the second inner diameter of the tubular member 110 may be adjustable between about | millimeter and about 12 millimeters. In some embodiments, the inner diameter of the distal portion 114 of the tubular member 110 and / or the second inner diameter of the tubular member 110 may be adjustable between about 2 millimeters and about 10.7 millimeters. In some embodiments, the inner diameter of the distal portion 114 of the tubular member 110 and / or the second inner diameter of the tubular member 110 may be adjustable between about 3 millimeters and about 9 millimeters. Other configurations are also contemplated. In some embodiments, the actuatable structure 140 may be responsive to voltage applied from the controller 30 such that the first inner diameter of the tubular member 110 and the second inner diameter of the tubular member 110 both change when the applied voltage changes. The controller 30 may be configured to send the applied voltage to the actuatable structure 140 to change the first inner diameter of the tubular member 110 to the first desired value for the first inner diameter, and the second inner diameter of the tubular member 110 to the second desired value for the second inner diameter. In some embodiments, the controller 30 may include a known correlation between the inner diameter of the tubular member 110 and the applied voltage. In some embodiments, the known correlation may be stored in the controller 30 in a lookup table and / or an algorithm. In some embodiments, the controller 30 may include a plurality of known correlations corresponding to a range of possible values ​​for the desired value of the inner diameter.Thus, a user can set or select the desired value for the internal diameter, and the controller 30 can be configured to check the desired value against the lookup table and / or the algorithm, and as long as the desired value is within the range of possible values, the controller 30 can automatically send the applied voltage corresponding to the desired value to the actuatable structure 140, which will then cause the internal diameter of the tubular element 110 to change by moving the actuatable structure 140 from the first configuration and / or the distribution configuration to the second configuration and / or the deployed configuration. In some embodiments, the cannula 100 may be a single-lumen cannula comprising the proximal portion 112 and the distal portion 114, as shown in [Fig. 2A], having a single lumen extending therethrough. The openings 120 and / or the openings 130 may be in fluid communication with the single lumen. In some embodiments, the cannula 100 may be a dual-lumen cannula comprising an inner tubular member 118 and an outer tubular member 116, as shown in [Fig. 2B], having a first lumen defined by the inner tubular member 118 and a second lumen defined between the inner tubular member 118 and the outer tubular member 116. inner tubular member 118 and the outer tubular member 116. In some embodiments, the inner tubular member 118 may be coaxial with the tubular member 116. In some embodiments, the tubular member 110 may be the inner tubular member 118 of the double-lumen cannula. In some embodiments, the tubular member 110 may be the outer tubular member 116 of the double-lumen cannula and / or the cannula 100. In some embodiments, the distal portion 114 may be a distal portion of the inner tubular member 118 of the double-lumen cannula and the proximal portion 112 may be a distal portion of an outer tubular member 116 of the double-lumen cannula and / or the cannula 100.The openings 120 may be in fluid communication with the first lumen defined by the inner tubular member 118, and the openings 130 may be in fluid communication with the second lumen defined between the inner tubular member 118 and the outer tubular member 116. In some embodiments, the discussion relating to the proximal portion 112 may be directed to a proximal portion of the inner tubular member 118 of the dual-lumen cannula and / or the cannula 100. Other configurations are also contemplated. Figures 3-8 schematically illustrate the cannula 100 and / or the tubular member 110 undergoing various optional passages of the actuatable structure 140 between the first configuration and / or the dispensing configuration and the second configuration and / or the deployed configuration. In Figures 3-9, the cannula 100 is illustrated as a double-lumen cannula with the inner tubular member shown in broken lines, but the cannula 100 may be understood to be a single-lumen cannula (devoid of the inner tubular member), the figures illustrating various changes to the tubular member, except Figures 6, 7 and 9, which illustrate modifications to the inner tubular member of the double-lumen cannula. As seen in [Fig. 3], in some embodiments of the single-lumen cannula, the actuatable structure 140 may be configured to expand radially in response to the external stimulus and / or the applied voltage such that the inner diameter and / or the outer diameter of the tubular member 110 expands radially. In some embodiments of the single-lumen cannula, when the actuatable structure 140 transitions from the first configuration and / or the dispensing configuration to the second configuration and / or the deployed configuration, the inner diameter and / or the outer diameter of the tubular member 110 expands radially.In some embodiments of the single-lumen cannula, when the actuatable structure 140 transitions from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration, the inner diameter and / or the outer diameter of the proximal portion 112 of the tubular member 110. and the distal portion 114 of the tubular member 110 are radially enlarged. In some embodiments of the single-lumen cannula, the actuatable structure may extend along both the proximal portion 112 of the tubular member 110 and the distal portion 114 of the tubular member 110. In some embodiments of the single-lumen cannula, the first plurality of openings 120 and / or the second plurality of openings 130 may be present or may be omitted. Optionally, the first plurality of openings 120 and / or the second plurality of openings 130 may provide fluid communication between the lumen of the tubular member 110 and an exterior of the cannula 100 and / or the body lumen in which the cannula 100 has been placed.Radially enlarging the inner diameter and / or outer diameter of the tubular member 110 in situ may allow for greater fluid flow through the cannula 100 while having a reduced size and / or cross-sectional area for insertion into the body lumen. Other advantages, including, but not limited to, improved sealing at an access site or puncture and / or puncture and / or maintaining patency of the body lumen, are also contemplated. As also seen in [Fig. 3], in some embodiments of the dual-lumen cannula, the actuatable structure 140 may be configured to radially expand in response to the external stimulus and / or the applied voltage such that the inner diameter and / or outer diameter of at least the distal portion of the outer tubular member 116 is radially expanded, and / or the inner diameter and / or outer diameter of the distal portion of the inner tubular member 118 is radially expanded.In some embodiments of the dual-lumen cannula, when the actuatable structure 140 transitions from the first configuration and / or the dispensing configuration to the second configuration and / or the deployed configuration, the inner diameter and / or the outer diameter of at least the distal portion of the outer tubular member 116 is radially enlarged, and / or the inner diameter and / or the outer diameter of the distal portion of the inner tubular member 118 is radially enlarged. In some embodiments of the dual-lumen cannula, the actuatable structure may extend along at least the distal portion of the outer tubular member 116 and the distal portion of the inner tubular member 118. In some embodiments of the dual-lumen cannula, the first plurality of openings 120 and / or the second plurality of openings 130 may be present or may be omitted.Optionally, the first plurality of openings 120 may provide fluid communication between the lumen of the inner tubular member 118 and the exterior of the cannula 100 and / or the body lumen in which the cannula 100 has been placed, and the second plurality of openings 130 may provide fluid communication between the lumen of the outer tubular member 116 and the exterior of the cannula 100 and / or the lumen. body lumen into which the cannula 100 has been placed. Radially enlarging the inner diameter and / or outer diameter of the tubular member 110 in situ may allow for greater fluid flow through the cannula 100 while having a reduced size and / or cross-sectional area for insertion into the body lumen. Other advantages, including, but not limited to, improved sealing at an access site or puncture and / or puncture and / or maintaining patency of the body lumen, are also contemplated. As seen in [Fig. 4], in some embodiments of the single-lumen cannula, the actuatable structure 140 may be configured to expand radially in response to the external stimulus and / or the applied voltage such that the first inner diameter and / or the first outer diameter of the proximal portion 112 of the tubular member 110 are radially expanded. In some embodiments of the single-lumen cannula, when the actuatable structure 140 transitions from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration, the first inner diameter and / or the first outer diameter of the proximal portion 112 of the tubular member 110 are radially expanded.In some embodiments of the single-lumen cannula, when the actuatable structure 140 transitions from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration, the first inner diameter and / or the first outer diameter of the proximal portion 112 of the tubular member 110 are radially enlarged, and the second inner diameter and / or the second outer diameter of the distal portion 114 of the tubular member 110 remain constant or generally constant. In some embodiments of the single-lumen cannula, the actuatable structure 140 may extend along the proximal portion 112 of the tubular member 110, and the distal portion 114 of the tubular member 110 may be devoid of the actuatable structure 140.In some embodiments of the single-lumen cannula, the first plurality of openings 120 and / or the second plurality of openings 130 may be present or may be omitted. If present, the first plurality of openings 120 and / or the second plurality of openings 130 may provide fluid communication between the lumen of the tubular member 110 and an exterior of the cannula 100 and / or the body lumen into which the cannula 100 has been placed. Radially enlarging the first inner diameter and / or the first outer diameter of the proximal portion 112 of the tubular member 110 in situ may allow for greater fluid flow through the proximal portion 112 of the tubular member 110 while having a reduced size and / or cross-sectional area for insertion into the body lumen. Other benefits including, but not limited to, improved sealing at a . access site or puncture and / or puncture and / or maintenance of the patency of the body lumen, are also considered. As also seen in [Fig. 4], in some embodiments of the double-lumen cannula, the actuatable structure 140 may be configured to radially expand in response to the external stimulus and / or applied voltage such that the inner diameter and / or outer diameter of at least the distal portion of the outer tubular member 116 are radially expanded and the inner diameter and / or outer diameter of the distal portion of the inner tubular member 118 remain constant or generally constant. In some embodiments of the double-lumen cannula, when the actuatable structure 140 transitions from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration, the inner diameter and / or outer diameter of at least the distal portion of the outer tubular member 116 are radially expanded.and the inner diameter and / or the outer diameter of the distal portion of the inner tubular member 118 remains constant or generally constant. In some embodiments of the double-lumen cannula, the actuatable structure 140 may extend along at least the distal portion of the outer tubular member 116, and the inner tubular member 118 may be devoid of the actuatable structure 140. In some embodiments of the double-lumen cannula, the first plurality of openings 120 and / or the second plurality of openings 130 may be present or may be omitted. Optionally, the first plurality of openings 120 may provide fluid communication between the lumen of the inner tubular member 118 and an exterior of the cannula 100 and / or the body lumen in which the cannula 100 has been placed,and the second plurality of openings 130 may provide fluid communication between the lumen of the outer tubular member 116 and the exterior of the cannula 100 and / or the body lumen in which the cannula 100 has been placed. Radially enlarging the inner diameter and / or outer diameter of at least the distal portion of the outer tubular member 116 in situ may allow for greater fluid flow through the proximal portion 112 of the tubular member 110 while having a reduced size and / or cross-sectional area for insertion into the body lumen. Other advantages, including, but not limited to, improved sealing at an access site or puncture and / or puncture and / or maintaining patency of the body lumen, are also contemplated. As seen in [Fig. 5], in some embodiments of the single-lumen cannula, the actuatable structure 140 may be configured to expand radially in response to the external stimulus and / or the applied voltage such that the second inner diameter and / or the second outer diameter of the distal portion 114 of the tubular member 110 are radially expanded. In some embodiments of the single-lumen cannula, when the actuatable structure 140 transitions from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration, the second inner diameter and / or the second outer diameter of the distal portion 114 of the tubular member 110 are radially enlarged. In some embodiments of the single-lumen cannula, when the actuatable structure 140 transitions from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration, the second inner diameter and / or the second outer diameter of the distal portion 114 of the tubular member 110 are radially enlarged, and the first inner diameter and / or the first outer diameter of the proximal portion 112 of the tubular member 110 remain constant or generally constant.In some embodiments of the single-lumen cannula, the actuatable structure 140 may extend along the distal portion 114 of the tubular member 110, and the proximal portion 112 of the tubular member 110 may be devoid of the actuatable structure 140. In some embodiments of the single-lumen cannula, the first plurality of openings 120 and / or the second plurality of openings 130 may be present or may be omitted. Optionally, the first plurality of openings 120 and / or the second plurality of openings 130 may provide fluid communication between the lumen of the tubular member 110 and an exterior of the cannula 100 and / or the body lumen in which the cannula 100 has been placed.Radially enlarging the second inner diameter and / or the second outer diameter of the distal portion 114 of the tubular member 110 in situ may allow for greater fluid flow through the distal portion 114 of the tubular member 110 while having a reduced size and / or cross-sectional area for insertion into the body lumen. Other advantages, including, but not limited to, improved sealing at an access site or puncture and / or puncture and / or maintaining patency of the body lumen, are also contemplated. As also seen in [Fig. 5], in some embodiments of the double-lumen cannula, the actuatable structure 140 may be configured to expand radially in response to the external stimulus and / or the applied voltage such that the inner diameter and / or the outer diameter of the distal portion of the inner tubular member 118 are radially expanded and the inner diameter and / or the outer diameter of at least the distal portion of the outer tubular member 116 remains constant or generally constant. In some embodiments of the double-lumen cannula, when the actuatable structure 140 transitions from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration, the inner diameter and / or the outer diameter of the distal portion of the inner tubular member 118 are radially expanded, and the inner diameter and / or the outer diameter external of at least the distal portion of the outer tubular member 116 remain constant or generally constant. In some embodiments of the double-lumen cannula, the actuatable structure 140 may extend along at least the distal portion of the inner tubular member 118, and the outer tubular member 116 may be devoid of the actuatable structure 140. In some embodiments of the double-lumen cannula, the first plurality of openings 120 and / or the second plurality of openings 130 may be present or may be omitted.Optionally, the first plurality of openings 120 may provide fluid communication between the lumen of the inner tubular member 118 and an exterior of the cannula 100 and / or the body lumen into which the cannula 100 has been placed, and the second plurality of openings 130 may provide fluid communication between the lumen of the outer tubular member 116 and the exterior of the cannula 100 and / or the body lumen into which the cannula 100 has been placed. Radially enlarging the inner diameter and / or outer diameter of the distal portion of the inner tubular member 118 in situ may allow for greater fluid flow through the distal portion of the inner tubular member 118 while having a reduced size and / or cross-sectional area for insertion into the body lumen.Other advantages, including, but not limited to, improved sealing at an access site or puncture and / or puncture and / or maintenance of patency of the body lumen, are also contemplated. As seen in [Fig. 6], in some embodiments of the dual-lumen cannula, the actuatable structure 140 may be configured to expand radially in response to the external stimulus and / or applied voltage such that the inner diameter and / or outer diameter of a proximal portion of the inner tubular member 118 (e.g., a portion of the inner tubular member 118 disposed proximate the distal end of the outer tubular member 116) are radially expanded and the inner diameter and / or outer diameter of at least the distal portion of the outer tubular member 116 remain constant or generally constant.In some embodiments, the inner diameter and / or outer diameter of the distal portion of the inner tubular member 118 (e.g., a portion of the inner tubular member 118 disposed distally of the distal end of the outer tubular member 116) remains constant or generally constant. In some embodiments of the dual-lumen cannula, when the actuatable structure 140 transitions from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration, the inner diameter and / or outer diameter of the proximal portion of the inner tubular member 118 is radially enlarged, and the inner diameter and / or outer diameter of at least the distal portion of the outer tubular member 116 remains constant or generally constant. generally constant. In some embodiments of the double-lumen cannula, the actuatable structure 140 may extend along the proximal portion of the inner tubular member 118, and the outer tubular member 116 may be devoid of the actuatable structure 140. In some embodiments, the distal portion of the inner tubular member 118 may be devoid of the actuatable structure 140. In some embodiments of the double-lumen cannula, the first plurality of openings 120 and / or the second plurality of openings 130 may be present or may be omitted.Optionally, the first plurality of openings 120 may provide fluid communication between the lumen of the inner tubular member 118 and an exterior of the cannula 100 and / or the body lumen in which the cannula 100 has been placed, and the second plurality of openings 130 may provide fluid communication between the lumen of the outer tubular member 116 and the exterior of the cannula 100 and / or the body lumen in which the cannula 100 has been placed. Radially enlarging the inner diameter and / or outer diameter of the proximal portion of the inner tubular member 118 in situ may allow for greater fluid flow through the proximal portion of the inner tubular member 118 and / or may reduce fluid flow through at least the distal portion of the outer tubular member 116.In some embodiments, the actuatable structure 140 may be used to control fluid flow within the outer tubular member 116. Other benefits are also contemplated. As seen in [Fig. / ], in some embodiments of the double-lumen cannula, the actuatable structure 140 may be configured to expand radially in response to the external stimulus and / or applied voltage such that the inner diameter and / or outer diameter of the inner tubular member 118 are radially expanded, and the inner diameter and / or outer diameter of at least the distal portion of the outer tubular member 116 remains constant or generally constant. In some embodiments of the double-lumen cannula, when the actuatable structure 140 transitions from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration, the inner diameter and / or the outer diameter of the inner tubular member 118 are radially expanded,and the inner diameter and / or outer diameter of at least the distal portion of the outer tubular member 116 remains constant or generally constant. In some embodiments of the double-lumen cannula, the actuatable structure 140 may extend along the proximal portion and the distal portion of the inner tubular member 118, and the outer tubular member 116 may be devoid of the actuatable structure 140. In some embodiments of the double-lumen cannula, the first plurality of openings 120 and / or the second plurality of openings 130 may be present or may be omitted. If applicable, the first, plurality of openings 120 may provide fluid communication between the lumen of the inner tubular member 118 and an exterior of the cannula 100 and / or the body lumen in which the cannula 100 has been placed, and the second plurality of openings 130 may provide fluid communication between the lumen of the outer tubular member 116 and the exterior of the cannula 100 and / or the body lumen in which the cannula 100 has been placed. Radially enlarging the inner diameter and / or outer diameter of the inner tubular member 118 in situ may allow for greater fluid flow through the inner tubular member 118 and / or may reduce fluid flow through at least the distal portion of the outer tubular member 116. In some embodiments, the actuatable structure 140 may be used to control fluid flow within the outer tubular member 116 and / or the inner tubular member 118.In some embodiments, radially enlarging the inner diameter and / or outer diameter of the inner tubular member 118 in situ may allow for greater fluid flow through the inner tubular member 118 while providing a reduced size and / or cross-sectional area for insertion of at least the distal portion of the inner tubular member 118 into the body lumen. Other advantages, including, but not limited to, improved sealing at an access site or puncture and / or puncture and / or maintaining patency of the body lumen, are also contemplated. As seen in [Fig. 8], in some embodiments of the single lumen cannula, the actuatable structure 140 may be configured to decrease radially in response to the external stimulus and / or the applied voltage such that the first inner diameter and / or the first outer diameter of the proximal portion 112 of the tubular member 110 decrease radially. In some embodiments of the single lumen cannula, when the actuatable structure 140 transitions from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration, the first inner diameter and / or the first outer diameter of the proximal portion 112 of the tubular member 110 decrease radially.In some embodiments of the single-lumen cannula, as the actuatable structure 140 transitions from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration, the first inner diameter and / or the first outer diameter of the proximal portion 112 of the tubular member 110 decreases radially, and the second inner diameter and / or the second outer diameter of the distal portion 114 of the tubular member 110 remains constant or generally constant. In some embodiments of the single-lumen cannula, the actuatable structure 140 may extend along the proximal portion 112 of the tubular member 110, and the distal portion 114 of the tubular member. 110 may be devoid of the actuatable structure 140. In some embodiments of the single-lumen cannula, the first plurality of openings 120 and / or the second plurality of openings 130 may be present or may be omitted. Optionally, the first plurality of openings 120 and / or the second plurality of openings 130 may provide fluid communication between the lumen of the tubular member 110 and an exterior of the cannula 100 and / or the body lumen in which the cannula 100 has been placed. Radially decreasing the first inner diameter and / or the first outer diameter of the proximal portion 112 of the tubular member 110 in situ may reduce fluid flow through the proximal portion 112 of the tubular member 110.In some embodiments, the actuatable structure 140 may be used to control fluid flow within the tubular member 110 and / or within the proximal portion 112 of the tubular member 110. Other benefits are also contemplated. As also seen in [Fig. 8], in some embodiments of the dual-lumen cannula, the actuatable structure 140 may be configured to decrease radially in response to the external stimulus and / or the applied voltage such that the inner diameter and / or outer diameter of at least the distal portion of the outer tubular member 116 decreases radially and the inner diameter and / or outer diameter of the inner tubular member 118 remains constant or generally constant.In some embodiments of the double-lumen cannula, as the actuatable structure 140 transitions from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration, the inner diameter and / or the outer diameter of at least the distal portion of the outer tubular member 116 decreases radially, and the inner diameter and / or the outer diameter of the inner tubular member 118 remains constant or generally constant. In some embodiments of the double-lumen cannula, the actuatable structure 140 may extend along at least the distal portion of the outer tubular member 116, and the inner tubular member 118 may be devoid of the actuatable structure 140. In some embodiments of the double-lumen cannula, the first plurality of openings 120 and / or the second plurality of openings 130 may be present or may be omitted.Optionally, the first plurality of openings 120 may provide fluid communication between the lumen of the inner tubular member 118 and an exterior of the cannula 100 and / or the body lumen in which the cannula 100 has been placed, and the second plurality of openings 130 may provide fluid communication between the lumen of the outer tubular member 116 and the exterior of the cannula 100 and / or the body lumen in which the cannula 100 has been placed. The radial decrease in the inner diameter and / or outer diameter of at least the distal portion of the outer tubular member 116 in situ may reduce fluid flow to . through at least the distal portion of the outer tubular member 116. In some embodiments, the actuatable structure 140 may be used to control fluid flow within the outer tubular member 116. Other benefits are also contemplated. As seen in [Fig.9], in some embodiments of the dual-lumen cannula, the actuatable structure 140 may be configured to decrease radially in response to the external stimulus and / or applied voltage such that the inner diameter and / or outer diameter of the inner tubular member 118 decreases radially and the inner diameter and / or outer diameter of at least the distal portion of the outer tubular member 116 remains constant or generally constant.In some embodiments of the double-lumen cannula, as the actuatable structure 140 transitions from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration, the inner diameter and / or the outer diameter of the inner tubular member 118 decreases radially, and the inner diameter and / or the outer diameter of at least the distal portion of the outer tubular member 116 remains constant or generally constant. In some embodiments of the double-lumen cannula, the actuatable structure 140 may extend along the proximal portion and the distal portion of the inner tubular member 118, and the outer tubular member 116 may be devoid of the actuatable structure 140. In some embodiments of the double-lumen cannula, the first plurality of openings 120 and / or the second plurality of openings 130 may be present or may be omitted.Optionally, the first plurality of openings 120 may provide fluid communication between the lumen of the inner tubular member 118 and an exterior of the cannula 100 and / or the body lumen in which the cannula 100 has been placed, and the second plurality of openings 130 may provide fluid communication between the lumen of the outer tubular member 116 and the exterior of the cannula 100 and / or the body lumen in which the cannula 100 has been placed. The radial decrease in the inner diameter and / or the outer diameter of the inner tubular member 118 in situ may reduce fluid flow through the inner tubular member 118 and / or may increase fluid flow through at least the distal portion of the outer tubular member 116.In some embodiments, the actuatable structure 140 may be used to control fluid flow within the outer tubular member 116 and / or the inner tubular member 118. Other benefits are also contemplated. [Fig. 10] illustrates an exemplary configuration of the actuatable structure 140. In some embodiments, the actuatable structure 140 may comprise and / or may be a helical coil. The actuatable structure 140 is illustrated in [Fig. 10] in the first configuration and / or the dispensing configuration. In In some embodiments, the actuatable structure 140 and / or the helical coil may comprise a plurality of adjacent windings. The plurality of adjacent windings may be spaced generally uniformly along the length of the actuatable structure 140 and / or the helical coil. In some embodiments, the plurality of adjacent windings may be spaced by varying distances along the length of the actuatable structure 140 and / or the helical coil. Other configurations are also contemplated. [Fig. 10A] illustrates an example of the actuatable structure 140 of [Fig. 10] in the second configuration and / or the deployed configuration. In some embodiments, in the second configuration and / or the deployed configuration, the actuatable structure 140 may be radially tapered relative to the first configuration and / or the delivery configuration. [Fig.10B] illustrates another example of the actuatable structure 140 of [Fig. 10] in the second configuration and / or the deployed configuration. In some embodiments, in the second configuration and / or the deployed configuration, the actuatable structure 140 may be radially enlarged relative to the first configuration and / or the dispensing configuration. In some embodiments, the actuatable structure 140 may be progressive such that the second configuration and / or the dispensing configuration depend on and / or vary depending on the external stimulus to which the actuatable structure 140 is subjected, as described herein. [Fig. 11] illustrates another exemplary configuration of the actuatable structure 140. In some embodiments, the actuatable structure 140 may comprise and / or may be a cage-like structure (e.g., a ribbed cage, etc.). The actuatable structure 140 is illustrated in [Fig. 11] in the first configuration and / or the dispensing configuration. In some embodiments, the actuatable structure 140 and / or the cage-like structure may comprise a plurality of curved ribs 142 extending from a longitudinal spine 141. In some embodiments, the plurality of curved ribs 142 may extend in an arcuate direction from the longitudinal spine 141. In some embodiments, the plurality of curved ribs 142 may extend circumferentially from the longitudinal spine 141.In some embodiments, a first portion of the plurality of curved ribs 142 may extend from the longitudinal spine 141 in a first arcuate direction from a first side of the longitudinal spine 141, and a second portion of the plurality of curved ribs 142 may extend from the longitudinal spine 141 in a second arcuate direction from a second side of the longitudinal spine 141. The first arcuate direction and / or the first side may be opposite the second. arcuate direction and / or to the second side, In some embodiments, the plurality of curved ribs 142 may extend alternately from opposite sides of the longitudinal spine 141. In other words, the direction in which the curved ribs 142 extend from the longitudinal spine 141 may alternate along the length of the longitudinal spine 141. In at least some embodiments, the plurality of curved ribs 142 may be monolithically formed and / or may be unitary with the longitudinal spine 141.In some embodiments, the plurality of curved ribs 142 may be configured to deflect and / or pivot at and / or about the longitudinal spine 141 as the actuatable structure 140 and / or the cage-like structure transition from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration. The plurality of curved ribs 142 may be spaced generally uniformly along the length of the actuatable structure 140 and / or the cage-like structure. In some embodiments, the plurality of curved ribs 142 may be spaced by varying distances along the length of the actuatable structure 140 and / or the cage-like structure.In some instances, the longitudinal spacing between adjacent curved ribs 142 may gradually increase in the distal direction, or the longitudinal spacing between adjacent curved ribs 142 may gradually decrease in the distal direction, if desired. Other configurations are also contemplated. [Fig. 11A] illustrates an example of the actuatable structure 140 of [Fig. 11] in the second configuration and / or the deployed configuration. In some embodiments, in the second configuration and / or the deployed configuration, the actuatable structure 140 may be radially decreased relative to the first configuration and / or the delivery configuration. [Fig. 11B] illustrates another example of the actuatable structure 140 of [Fig. 11] in the second configuration and / or the deployed configuration.In some embodiments, in the second configuration and / or the deployed configuration, the actuatable structure 140 may be radially enlarged relative to the first configuration and / or the delivery configuration. In some embodiments, the actuatable structure 140 may be progressive such that the second configuration and / or the delivery configuration depend on and / or vary depending on the external stimulus to which the actuatable structure 140 is subjected, as described herein. [Fig. 12] illustrates another example configuration of the actuatable structure 140. In some embodiments, the actuatable structure 140 may comprise and / or may be a braided stent-like structure. The actuatable structure 140 is illustrated in [Fig. 12] in the first configuration and / or the delivery configuration. In some embodiments, the actuatable structure 140 and / or the braided stent-like structure may comprise a plurality of intertwined filaments 143. In some embodiments, the plurality of intertwined filaments 143 may be configured to move relative to one another as the actuatable structure 140 and / or the braided stent-like structure transitions from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration. Other configurations are also contemplated. [Fig. 12A] illustrates an example of the actuatable structure 140 of [Fig. 12] in the second configuration and / or the deployed configuration. In some embodiments, in the second configuration and / or the deployed configuration, the actuatable structure 140 may be radially tapered and / or longitudinally elongated relative to the first configuration and / or the delivery configuration. [Fig.12B] illustrates another example of the actuatable structure 140 of [Fig. 12] in the second configuration and / or the deployed configuration. In some embodiments, in the second configuration and / or the deployed configuration, the actuatable structure 140 may be radially enlarged and / or longitudinally shortened relative to the first configuration and / or the delivery configuration. In some embodiments, the actuatable structure 140 may be progressive such that the second configuration and / or the delivery configuration depend on and / or vary depending on the external stimulus to which the actuatable structure 140 is subjected, as described herein. In some embodiments, a method of connecting a patient's vasculature to the extracorporeal life support (ECLS) system 20 may include advancing the delivery sheath 10 into the patient's vasculature. The patient's vasculature may include one or more of the patient's arteries, veins, and / or heart. [Fig. 13] illustrates an exemplary configuration and / or placement of the cannula 100 in the patient's vasculature relative to the heart 40. For illustrative purposes, the heart 40 includes the right atrium 42, the right ventricle 44, the left ventricle 46, and the left atrium 48. The left ventricle 46 is fluidly connected to the aorta 50, and the right ventricle 44 is fluidly connected to the pulmonary artery 52. ​​It is understood that the cannula 100 may be arranged and / or placed in other portions of the patient's vasculature, as is known in the art. As described herein, the delivery sheath 10 may have the cannula 100 including the tubular member 110 defining a lumen, and the actuatable structure 140 attached to the tubular member 110 disposed therein. In some embodiments, the cannula 100 may be a single-lumen cannula as described herein. In some embodiments, the cannula 100 may be a double-lumen cannula as described herein. In some embodiments, the method may include advancing the delivery sheath 10 into and / or through the superior vena cava 54 and into the right atrium 42. In some embodiments, the delivery sheath 10 may be advanced into and / or through the right ventricle 44 and into the pulmonary artery 52. ​​In some embodiments, the method may include moving the delivery sheath 10 relative to the cannula 100 to expose the cannula 100 within the patient's vasculature. In the exemplary configuration of [Fig. 13], the method may include moving the delivery sheath 10 relative to the cannula 100 to expose the cannula 100 within the patient's heart 40.In some embodiments, the method may include withdrawing the delivery sheath 10 relative to the cannula 100 while the cannula 100 is maintained in a generally constant position relative to the patient's vasculature. In some embodiments, the method may include advancing the cannula 100 out of the distal end of the delivery sheath 10 while the delivery sheath 10 is maintained in a generally constant position relative to the patient's vasculature. In some embodiments, the method may include transitioning the actuatable structure 140 from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration while at least a portion of the cannula 100 is disposed within the patient's vasculature to change the inner diameter and / or the outer diameter of the tubular member 110. In some embodiments of the single lumen cannula, the method may include changing the actuatable structure 140 from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration while at least a portion of the cannula 100 is disposed within the patient's vasculature to change the first inner diameter and / or the first outer diameter of the proximal portion 112 of the tubular member 110.In some embodiments of the single lumen cannula, the method may include changing the actuatable structure (140) from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration while at least a portion of the cannula (100) is disposed within the patient's vasculature to change the second inner diameter and / or the second outer diameter of the distal portion (114) of the tubular member (110). In some embodiments of the single lumen cannula, the method may include changing the actuatable structure 140 from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration while at least a portion of the cannula 100 is disposed within the patient's vasculature. to change the first internal diameter and / or the first external diameter of the proximal portion 112 of the tubular element 110 and the second internal diameter and / or the second external diameter of the distal portion 114 of the tubular element 110. In some embodiments of the double-lumen cannula, the method may include changing the actuatable structure 140 from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration while at least a portion of the cannula 100 is disposed within the patient's vasculature to change the inner diameter and / or the outer diameter of at least a portion of the inner tubular member 118. In some embodiments of the double-lumen cannula, the method may include changing the actuatable structure 140 from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration while at least a portion of the cannula 100 is disposed within the patient's vasculature to change the inner diameter and / or the outer diameter of at least a portion of the outer tubular member 116.In some embodiments of the dual-lumen cannula, the method may include transitioning the actuatable structure 140 from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration while at least a portion of the cannula 100 is disposed within the patient's vasculature to change the inner diameter and / or outer diameter of at least a portion of the inner tubular member 118 and at least a portion of the outer tubular member 116. In some embodiments, transitioning the actuatable structure 140 from the first configuration and / or the delivery configuration to the second configuration and / or the deployed configuration while at least a portion of the cannula 100 is disposed within the patient's vasculature may include applying an external stimulus to the actuatable structure 140. In some embodiments, the external stimulus may be applied by the controller 30. The controller 30 may be in electronic and / or electrical communication with the actuatable structure 140. In some embodiments, the external stimulus may be applied to the actuatable structure 140 actively and / or selectively (e.g., an applied voltage). In some embodiments, the external stimulus may be applied passively (e.g., body heat).In some embodiments, the external stimulus may comprise a plurality of stimuli. In some embodiments, the method may include removing the delivery sheath 10 from the patient's vasculature. In some embodiments, the method may include fluidly connecting the cannula 100 to the extracorporeal life support (ECLS) system 20. In some embodiments, the method may include fluidly connecting the cannula 100 to the extracorporeal life support (ECLS) system 20. lization, the method may include fluidly connecting the cannula 100 to the extracorporeal life support (ECLS) system 20 using means, methods and / or techniques known in the art. In some embodiments, such as in a double-lumen cannula, the second plurality of openings 130 may be in fluid communication with the extracorporeal life support (ECLS) system 20 and may be configured to provide fluid flow from the patient's vasculature (e.g., right atrium 42, etc.) to the extracorporeal life support (ECLS) system via the outer tubular member 116, and / or the first plurality of openings 120 may be in fluid communication with the extracorporeal life support (ECLS) system 20 and may be configured to provide fluid flow into the patient's vasculature (e.g., pulmonary artery 52, etc.) from the extracorporeal life support (ECLS) system 20 via the inner tubular member 118, as illustrated by arrows in [Fig. 13]. Other configurations are also being considered.For example, in a single lumen cannula, the first plurality of openings 120 and / or the second plurality of openings 130, if applicable, may be configured to provide fluid flow from the patient's vasculature to the extracorporeal life support (ECLS) system 20. In another example, in a single lumen cannula, the first plurality of openings 120 and / or the second plurality of openings 130, if applicable, may be configured to provide fluid flow from the extracorporeal life support (ECLS) system 20 to the patient's vasculature. The materials that may be used for the various components of the cannula and the various elements thereof described herein may include those commonly associated with medical devices. For simplicity, the following discussion refers to the device. However, this is not intended to limit the devices, components, and methods described herein, as the discussion may be applied to other elements, members, components, or devices described herein, such as, but not limited to, the delivery sheath, the tubular member, the inner tubular member, the outer tubular member, the actuatable structure, etc., and / or elements or components thereof. In some embodiments, the device and / or components thereof may be fabricated from a metal, a metal alloy, a polymer (some examples of which are described below), a metal-polymer composite, a ceramic, combinations thereof, and the like, or another suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM), polyether block ester, polyurethane, poly- propylene (PP), polyvinyl chloride (PVC), polyether ester, ether or ester based copolymers (e.g. butylene / poly(alkylene ether) phthalate and / or other polyester elastomers), polyamide, polyamide elastomers, polyamide / ether block, polyether block amide (PEBA, e.g. available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), high density polyethylene, low density polyethylene, linear low density polyethylene, polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide, polysulfone, nylon, nylon-12, perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol,polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), , poly(styrene-b-isobutylene-b-styrene), polycarbonates, polyisobutylene (PIB), polyisobutylene polyurethane (PIBU), polyurethane-silicone copolymers, jonomers, biocompatible polymers, other suitable materials, or blends, combinations, copolymers thereof, polymer / metal composites, and the like. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the blend may contain up to about 6% LCP. Examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; a nickel-titanium alloy such as linear elastic and / or superelastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys, nickel-copper alloys, nickel-cobalt-chromium-molybdenum alloys, nickel-molybdenum alloys, other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys; platinum-enriched stainless steel; titanium; combinations of these; or any other suitable material. In some embodiments, the device and / or other elements described herein may comprise and / or be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents may include anti-thrombogenic agents (such as heparin, heparin derivatives, urokinase and PPack (dextrophenylalanine-proline-arginine-chloromethyl-ketone)); anti-protein and / or anti-bacterial agents (such as 2-methacryroyloxyethylphosphorylcholine (MPC) and its polymers or copolymers); anti-proliferative agents (such as enoxaparin, angiopeptin, monoclonal antibodies capable of blocking the proli- smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine); antineoplastic / antiproliferative / antimitotic agents (such as paclitaxel, S-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine); anticoagulants (such as D-Phe-Pro-Arg chloromethylketone, a compound containing an RGD peptide, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors and tick antiplatelet peptides); vasodilating agents;and agents that interfere with endogenous vasoactive mechanisms. It should be understood that this disclosure is, in most respects, illustrative only. Changes may be made in the details, particularly with respect to the shape, size, and arrangement of steps, without exceeding the scope of the disclosure. This may include, to the extent appropriate, the use of any of the features of an exemplary embodiment used in other embodiments.

Claims

Claims

1. Canulc (100) for an extracorporeal life support system, including: a tubular member (110) formed from a polymeric material and having a lumen extending from a proximal end to a distal end; and an actuatable structure (140) incorporated in the polymer material; wherein the actuatable structure (140) is configured to be sensitive to an external stimulus such that an internal diameter of the tubular member (110) changes when the external stimulus changes.

2. The cannula of claim 1, wherein the tubular member (110) is an inner tubular element (118) of a double cannula lumen or an external tubular element (116) of a double cannula light.

3. The cannula of claim 1, wherein the actuatable structure (140) comprises a shape memory material.

4. The cannula of claim 1, wherein the tubular member (110) comprises a proximal portion (112) having a first outer diameter and a distal portion (114) having a second outer diameter less than the first outer diameter.

5. The cannula of claim 4, wherein the actuatable structure (140) is disposed within the distal portion (114) of the element tubular (110), in particular the actuatable structure (140) extends from proximally from the distal end of the tubular element (110).

6. The cannula of claim 1, wherein the actuatable structure (140) is configured to be responsive to one of an external stimulus: a applied voltage, temperature and light.

7. A system for use with an ex-life support system tracorporeal, including: a cannula (100) comprising a tubular element (110) defining a light ; an actuatable structure (140) attached to the tubular member (110); and a control device (30) in electrical communication with the actionable structure (140); wherein the actuatable structure (140) is configured to be responsive to a voltage applied from the control device (30) so that an internal diameter of the tubular element (110) changes when the applied voltage changes; wherein the control device (30) is configurable by a user lizer to set a desired value for an internal diameter of the tubular element (110); wherein the control device (30) comprises a correlation known between the internal diameter of the tubular element (110) and the applied voltage, and the control device (30) is configured to send the applied voltage to the actuable structure (140) in order to change the internal diameter of the tubular element (110) to the value desired for the internal diameter.

8. The system of claim 7, wherein the inner diameter of the tubular member (110) can be enlarged or reduced in situ.

9. The system of claim 7, wherein the internal diameter of a distal portion (114) of the tubular element (110) is adjustable between about 2 mm and about 10.7 mm.

10. The system of claim 7, wherein a portion of the element tubular (110) is devoid of the actuable structure (140), in par- in particular the part of the tubular element (110) devoid of the structure actuable (140) is configured to be disposed outside the body of a patient.