Cannula insertion system and method of using the same

Abstract

A cannulation system for cannulating a blood vessel includes a cannula system having a cannula defining a cannula lumen and having a distal end and a proximal end. The system includes a cannulation device for coupling with the system, the cannulation device including: a dilator having a dilator body and a dilator lumen; a needle having a needle body and a needle lumen, the needle being translatable along a first direction within the dilator lumen; a movable dilator actuator configured to move the dilator along the first direction; a movable needle actuator configured to cause movement of the needle along the first direction; and a housing defining a housing recess. The housing recess is configured to receive the cannula system, the dilator, and the needle. The needle and dilator are configured to be moved along the first direction within the cannula lumen.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 017,204, filed Apr. 29, 2020, which is hereby incorporated by reference in its entirety for all purposes.

[0002] [Technical Field] The present disclosure relates to embodiments of a cannula insertion system that includes a cannula system and a cannula insertion device.

Background Art

[0003] Extremely preterm birth is a major cause of morbidity and mortality among infants in the United States, with more than one - third of all infant deaths and one - half of cerebral palsy diagnoses being due to preterm birth. Respiratory insufficiency is the most common and difficult problem associated with extremely preterm birth, as gas exchange in extremely preterm neonates is impaired by the structural and functional immaturity of the lungs. Advances in neonatal intensive care have improved survival and pushed the limits of viability of preterm neonates to 22 - 24 weeks of gestation, which is characterized by the transition of lung development from the canalicular stage to the terminal sac stage. Survival is possible, but chronic lung disease and other complications of organ immaturity still exist at high rates, especially in neonates born before 28 weeks of gestation. The development of a system that can support normal neonatal growth and organ maturation even for several weeks could significantly reduce the morbidity and mortality of extremely preterm birth and improve the quality of life of survivors.

Summary of the Invention

Means for Solving the Problems

[0004] The foregoing deficiencies are addressed by the cannula insertion systems and methods of using them described throughout this specification. According to one aspect of the disclosure, a cannula insertion system for inserting a cannula into a blood vessel of a tissue includes a cannula system having a cannula that defines a cannula lumen therethrough. The cannula has a distal end and a proximal end opposite the distal end. The cannula insertion system further includes a cannula insertion device configured to couple with the cannula system. The coupling between the cannula insertion device and the cannula system can be made releasable. The cannula insertion device includes an introducer having an introducer body that defines an introducer lumen therethrough; a needle having a needle body that defines a needle lumen therethrough, the needle being translatable along a first direction inside the introducer lumen; an introducer actuator configured to be moved such that movement of the introducer actuator causes movement of the introducer along the first direction; a needle actuator configured to be moved such that movement of the needle actuator causes movement of the needle along the first direction; and a housing that defines a housing recess therein. The housing recess is configured to receive the cannula system, the introducer, and the needle. The needle and the introducer of the cannula insertion device are configured to be moved along the first direction inside the cannula lumen.

[0005] The actuator can be configured to translate the needle from a first position, where the distal end of the needle is positioned distal to the distal end of the introducer, to a second position, where the distal end of the needle is positioned proximal to the distal end of the introducer.

[0006] The cannula system can include a Y-connector adjacent to the proximal end of the cannula, the Y-connector having a first proximal portion defining a first proximal channel and a second proximal portion defining a second proximal channel. The first and second proximal channels can be configured to be in fluid communication with the cannula lumen. In some embodiments, the first proximal portion can define a slit seal that separates the first proximal channel from the second proximal channel. The slit seal has an open configuration through which the dilator and the needle are inserted, and a closed configuration through which the needle and the dilator do not extend. When the slit seal is in the closed configuration, liquid from the cannula lumen is prevented from entering the first proximal channel. In some embodiments, the cannula insertion system can include a plug configured to be removably inserted into the first proximal channel.

[0007] The cannula system can include a locking element thereon, and the housing can also include a locking element thereon. The locking element of the cannula system can be configured to releasably engage the locking element of the housing such that the cannula system is attached to the housing.

[0008] The system can further include a collet jaw configured to releasably secure the cannula to a blood vessel. The collet jaw can be attached to the cannula system. The collet jaw can have a base, deformable arms, and a head. When the collet jaw is in the open position, the head is spaced apart from the blood vessel and the cannula, and when the collet jaw is in the closed position, the head is in contact with the tissue and the blood vessel is held in place between the collet jaw and the cannula.

[0009] The tissue can be physiological tissue such as an organ. In some embodiments, the tissue can include the umbilical cord of a newborn. The head of the collec joe can contact the umbilical sheath of the umbilical cord, the Wharton's jelly of the umbilical cord, or the blood vessel itself. In some embodiments, the collec joe can include teeth on the head that extend towards the blood vessel. The teeth can be configured to bite into the tissue (e.g., the umbilical cord) when the collec joe is in a second position.

[0010] In some embodiments, the housing of the system can include a translucent portion configured to allow visibility into the housing recess through the housing.

[0011] The cannula system can be configured to be operatively connected to an extracorporeal membrane oxygenation (ECMO) system.

[0012] In some embodiments, the cannula insertion system can be used outside of the cardiovascular system, for example, within the urinary system, digestive system, lymphatic system, or another part of the body. In some embodiments, the cannula insertion system can be used with a ureter. In other embodiments, the cannula insertion system can be used with a bile duct.

[0013] According to another aspect of the present disclosure, a method of inserting a cannula into a blood vessel in a tissue includes creating an opening in the blood vessel wall by moving a needle towards and through the wall of the blood vessel to create a hole in the wall at the distal end of the needle; inserting a dilator into the opening to expand the opening; retracting the needle so that the needle exits the blood vessel; retracting the dilator so that the dilator exits the blood vessel; inserting the cannula into the opening in the blood vessel wall; and fixing the cannula within the blood vessel. The cannula defines a cannula lumen that extends between a distal end and a proximal end. The dilator and the needle can move within the cannula lumen. The steps described herein need not be performed in the recited order.

[0014] In some aspects of the method, the needle can define a distal end and a proximal end opposite the distal end, and the dilator can define a dilator lumen extending through the dilator between the distal end and the proximal end. The step of retracting the needle can include moving the needle within the dilator lumen from a first position where the distal end of the needle is outside the dilator lumen and distal to the distal end of the dilator to a second position where the distal end of the needle is within the dilator lumen and proximal to the distal end of the dilator.

[0015] The step of fixing the cannula to the blood vessel can include moving the collet jaw from an unlocked position where the collet jaw does not contact the tissue to a locked position where the collet jaw strongly clamps the tissue, the blood vessel is held between the collet jaw and the cannula, and at least a portion of the blood vessel is prevented from translating relative to the cannula. In some aspects, the method can further include the step of biting into the tissue by teeth disposed on the collet jaw.

[0016] The tissue can be physiological tissue such as an organ. In some aspects, the tissue can include the umbilical cord of a newborn.

[0017] The method can include the step of connecting the cannula to an extracorporeal membrane oxygenation (ECMO) system.

[0018] In some aspects, the cannula can be connected to a Y-connector that is divided into a first proximal portion and a second proximal portion separate from the first proximal portion. The step of connecting the cannula to the ECMO system can include the step of connecting the second proximal portion of the Y-connector to the ECMO system.

[0019] The method may further include the step of exiting the dilator and the needle from the cannula lumen after the step of securing the blood vessel to the cannula. In some embodiments, the cannula may be connected to a Y-connector that is divided into a first proximal portion and a second proximal portion separate from the first proximal portion, and the step of exiting the dilator and the needle from the cannula lumen may include the step of moving the dilator and the needle through the first proximal portion. In some embodiments, the method may further include the step of moving the needle and the dilator through a slit seal defined in the first proximal portion of the Y-connector.

[0020] In some embodiments, the method may further include the step of inserting a plug into the first proximal channel of the Y-connector to prevent the outflow of blood from the first proximal portion.

[0021] According to another aspect of the present disclosure, a cannula system includes a cannula having a distal end and a proximal end opposite the distal end; a cannula lumen extending through the cannula between the distal end and the proximal end; and a slit seal disposed on the cannula and configured to receive a cannula insertion device. The cannula system is configured to be in fluid communication with a blood vessel and also with an oxygenation device. The blood vessel can be one within a tissue. The tissue can be a physiological tissue such as an organ. In some embodiments, the tissue can include the umbilical cord of a neonate, and the cannula system can be configured to be in fluid communication with the blood vessels of the umbilical cord and also with an oxygenation device.

[0022] In some embodiments, the cannula of the cannula system may further include a Y-shaped connector having a first proximal portion and a second proximal portion; and a slit seal disposed on the cannula. The slit seal may be configured to receive a cannula insertion device therethrough. The cannula lumen may extend through the second proximal portion of the Y-shaped connector. The slit seal may be configured to permit fluid communication between the first proximal portion and the cannula lumen. The cannula system may optionally include one or more features of the cannula systems described throughout this specification.

[0023] According to another aspect of the present disclosure, a cannula for fluid communication with a blood vessel of a tissue includes a distal end; a proximal end opposite the distal end; a cannula lumen extending through the cannula between the distal end and the proximal end; a Y-shaped connector having a first proximal portion and a second proximal portion; and a slit seal disposed on the cannula and configured to receive a cannula insertion device therethrough. The cannula lumen extends through the second proximal portion of the Y-shaped connector. The slit seal is configured to permit fluid communication between the first proximal portion and the cannula lumen. The tissue can be a physiological tissue such as an organ. In some embodiments, the tissue can include the umbilical cord of a newborn. The cannula may optionally include one or more features of the cannulas described throughout this specification.

[0024] The foregoing summary, as well as the following detailed description of illustrative embodiments of the present application, will be better understood when read in conjunction with the accompanying drawings. For the purpose of illustrating the present disclosure, the drawings depict illustrative embodiments. However, it should be understood that the present application is not limited to the specific embodiments and methods disclosed, and reference should be made to the claims for that purpose.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0026] Certain terms are used for convenience in the following description but are not limiting. As used herein, the term "aligned" with respect to two elements along a direction means that a straight line that passes through one of those elements and is parallel to that direction also passes through the other of the two elements.

[0027] Aspects of the present disclosure will now be described in detail with reference to the drawings, in which like reference numerals refer to like elements throughout, unless otherwise specified. Certain terms are used herein for convenience only and are not limiting. As used herein, the term "plurality" means two or more. The terms "a part" and "at least a part" of a structure include the whole of that structure. Certain features of the present disclosure described herein in the context of separate embodiments may be provided in combination in a single embodiment. Conversely, various features of the present disclosure described in the context of a single embodiment may be provided separately or in any partial combination. The terms "proximal" and "distal" can refer to the position of a part of a device relative to the remainder or opposite end of the device when appearing in the drawings. The proximal end may be used to refer to the end that the user operates. The distal end may be used to refer to the end of the device that is inserted and advanced and is furthest from the user. As will be appreciated by those skilled in the art, the use of proximal and distal may vary in another context, such as in an anatomical context where proximal and distal are used with reference to the patient, or when the entry point is distal from the user.

[0028] One of the problems associated with existing systems that can support normal neonatal development and organ maturation is connecting the neonatal circulatory system to an oxygenation device configured to oxygenate the neonatal blood supply once the neonate is separated from the uterus. Cannulation of small blood vessels such as the arteries and veins within the umbilical cord requires precise manipulation of the devices used in the cannulation procedure. Further, since the blood supply within the neonate is low, cannulation of the blood vessels within the umbilical cord must be performed quickly and with minimal neonatal blood loss to maximize the chances of a successful outcome. Additionally, by reducing the time required to insert a cannula into the umbilical cord and the amount of stimulation applied to the umbilical cord, umbilical cord spasms can be reduced or prevented, and the time the neonate is without receiving oxygen can be reduced, thus lowering the potential for adverse effects due to hypoxia.

[0029] Accordingly, a cannula insertion system configured to quickly, effectively, and safely create an opening into a blood vessel, such as a vein or artery inside the umbilical cord, attach a cannula to the blood vessel, provide a passage for blood to enter and exit the blood vessel, and establish blood flow between a neonate and an oxygenation device, can increase the likelihood of success of a cannula insertion procedure.

[0030] Generally, a cannula insertion system can include a cannula insertion device configured to open a passage into a blood vessel and insert a cannula into the blood vessel, such that blood can flow from the blood vessel into the cannula or vice versa. The cannula insertion system can also include a needle assembly, a dilator assembly, and a cannula. The blood vessel can be inside the body, such as inside a human body. According to one aspect of the present disclosure, the blood vessel can form part of an external blood circuit outside the body, such as the umbilical cord of a full-term or premature neonate.

[0031] The disclosed aspects can be utilized with various humans or animals. Specifically, these embodiments can be used to insert a cannula into a blood vessel in the umbilical cord of a pediatric patient, such as a premature neonate. Once the cannula is inserted into the blood vessel, blood can flow from the umbilical cord through the cannula to a desired destination, such as an external blood circulation circuit. Some of the disclosed ones enable the cannula insertion process to be performed with one hand and without additional tools or assistance, thus improving ease of use and reducing the need for extra components or personnel in the cannula insertion space. This reduces the risk of using the wrong medical tool or inappropriately combining various tools in an attempt to achieve cannula insertion. By enabling the user to operate the cannula insertion system with one hand, the user's other hand is free to perform other tasks.

[0032] In some embodiments, the systems disclosed throughout this application can be used outside of the cardiovascular system. In some embodiments, the system can be used to insert a cannula into a lumen or blood vessel within the urinary system, digestive system, lymphatic system, or another part of the body. For example, in some embodiments, the systems and methods described herein can be used with the ureter or bile duct.

[0033] In one preferred embodiment, the cannula insertion system includes a cannula insertion device and a cannula system. The cannula system can be used to transport blood from a neonate between one or more external medical devices. The cannula system can be removably connected to the umbilical cord of the neonate. For example, the cannula insertion system can have multiple cannula systems, each connected to a separate blood vessel within the umbilical cord. In a preferred embodiment, two cannula systems can be connected to separate arteries, and one cannula system can be connected to a vein within the umbilical cord, thus forming a circulation loop in which blood exits the neonate, moves into the cannula system, moves into the connected circulation circuit, and then returns to the neonate. In some embodiments, if the cannula insertion process must be repeated, (as described in detail below) the cannula system is disengaged from the blood vessel and surrounding tissue, and the cannula insertion system is reset. The cannula system can then be introduced into a different part of the umbilical cord, and the first part of the umbilical cord that was used can be cut.

[0034] Continuing with the preferred embodiments, the cannula system can releasably engage a cannula insertion device, thereby facilitating connecting and securing the cannula system to respective blood vessels. The cannula insertion system can be handheld and designed to be operated by the user with the same hand that holds it. With such one-handed operation, the user can use the other hand for other tasks. Generally, in the preferred embodiments, the cannula insertion system can be configured to penetrate a target blood vessel, expand an opening in the vessel wall, and connect the cannula system to the blood vessel (e.g., by inserting a portion of the cannula system through the created opening into the blood vessel) and secure the cannula system to the blood vessel. Once the necessary steps are performed and the cannula system is secured to the blood vessel, the cannula insertion device can be detached from the cannula system.

[0035] Referring to FIGS. 1 - 7A, cannula insertion system 10 includes a cannula insertion device 20. Cannula insertion device 20 has a housing 220 that defines an internal housing recess 222 (see FIGS. 7 and 7A). Recess 222 can receive cannula system 28 therein. In some aspects, housing 220 can define a transparent or translucent portion 230 through which the user can observe the movement of components and the flow of blood through cannula system 28. The transparent or translucent portion 230 includes a transparent or translucent portion that enables the user to view at least a portion of housing recess 222.

[0036] A flashback chamber 231 (see FIG. 2) is disposed within the recess 222 and may be visible through the transparent or translucent portion 230 and may be configured to provide information to a user of the cannula insertion device 20. For example, the cannula insertion device 20 may be configured to indicate that the needle has successfully entered a blood vessel. When the blood vessel into which the cannula is to be inserted is connected to the cannula insertion system, fluid (e.g., blood) from the blood vessel can move through the cannula insertion device 20 and into the flashback chamber 231. The flashback chamber 231 defines an opening 232 through which blood can drip into the portion of the recess 222 that can be seen through the transparent or translucent portion 230, thus indicating that the blood vessel has been successfully cannulated. In some embodiments, prior to inserting the cannula into the blood vessel, the user can introduce a predetermined amount of fluid (e.g., saline) into the flashback chamber 231 through the opening 232 (e.g., by injecting the fluid). The cannula system can be primed with a suitable material (e.g., blood, saline, or a known composition such as PlasmaLyte) prior to use. Blood that moves through the flashback chamber 231 when the needle is successfully inserted can then be accelerated in its flashback time by the fluid within the flashback chamber 231, and droplets of the mixture can drip from the opening 232. Visualization of the flashback serves as an indication that the needle has pierced the blood vessel wall and entered the blood vessel. If blood does not drip from the flashback chamber 231, this can indicate, for example, that the needle did not properly enter the blood vessel, that the needle inadvertently pierced the opposite blood vessel wall and exited the blood vessel, and / or that there is a mechanical blockage within the cannula insertion device 20. An elastomeric plug 233 can be removably positioned within the opening 232. The plug 233 can be moved away from the opening 232 when the cannula system is primed. After the needle is retracted, the plug 233 is disposed within the opening 232 to prevent fluid from exiting the needle lumen, thus reducing blood loss.The plug can further serve as a physical barrier to prevent debris from entering the flashback chamber 231 through the opening 232.

[0037] The housing 220 can be sized such that the cannula insertion device 20 can be held by the user with one hand. It will be appreciated that the housing 220 need not fit entirely within the user's palm and may extend in one or more directions from that hand (see, e.g., FIG. 23). The housing 220 extends between a distal end 221 and a proximal end 223 opposite the distal end 221. The housing 220 has a maximum length L extending along an axis parallel to D1 from the distal end 221 to the proximal end 223, a maximum width W extending along an axis perpendicular to the length L, and a maximum height H extending along an axis perpendicular to both the length L and the width W (see FIG. 3). In some embodiments, the housing 220 can have a length L up to about 300 mm, up to about 250 mm, up to about 235 mm, up to about 200 mm, or another suitable length. In some embodiments, the housing 220 can have a width W up to about 50 mm, up to about 40 mm, up to about 30 mm, or another suitable width. In some embodiments, the housing 220 can have a height H up to about 50 mm, up to about 40 mm, up to about 30 mm, or another suitable height. In some particular embodiments, the housing 220 can have a length L of about 150 mm to about 300 mm, preferably about 175 mm to about 275 mm, more preferably about 175 mm to about 250 mm, a width W of about 20 mm to about 40 mm, preferably about 25 mm to about 35 mm, and a height H of about 25 mm to about 35 mm. In one embodiment, the housing 220 can have a length L of about 200 mm, a width W of about 28 mm, and a height H of about 31 mm. It will further be appreciated that the housing 220 can have different or additional dimensions, and that its specific size and shape will depend on the intended use. The exact dimensions of the housing 220, as well as the cannula insertion device 20 or the cannula insertion system 10 as a whole, can be selected to enable use by the user with one hand.For example, the housing 220 can be sized such that the average user can perform the expected separate functions of the cannula insertion system (e.g., retracting the needle, retracting the dilator, and disengaging the cannula from the cannula insertion device) without substantially repositioning the housing 220 in their hand between functions, and in some preferred embodiments, all functions can be performed with the same finger (e.g., the thumb of the hand holding the housing).

[0038] Referring to FIGS. 8 and 9, the cannula insertion system 10 can include a needle assembly 22. The housing recess 222 can be configured to receive the needle assembly 22. The needle assembly 22 can include a needle 40, which is configured to pierce a blood vessel, thereby creating a passageway into the blood vessel. According to one aspect of the present disclosure, the needle 40 can be configured to pierce a blood vessel, such as a blood vessel located within the umbilical cord of a neonate, and open a passageway into that blood vessel. The needle 40 can include a needle body 42, which extends from a proximal end 44 of the needle 40 to a distal end 46 of the needle 40. The proximal end 44 of the needle 40 can be spaced in a proximal direction PD from the distal end 46 of the needle 40, and the distal end 46 can be spaced in a distal direction DD from the proximal end 44 of the needle 40. As shown in the illustrated embodiment, the needle body 42 can be elongated along a first direction D1 that extends from the proximal end 44 to the distal end 46, or vice versa. The first direction D1 is bidirectional and can include both the proximal direction PD and the distal direction DD. The first direction D1 can be used for reference with other components of the cannula insertion system described throughout this specification.

[0039] The needle 40 defines a length L1 measured between the proximal end 44 and the distal end 46 of the needle 40. According to one embodiment, the length L1 can be from about 25 mm to about 305 mm. According to one embodiment, the length L1 can be from about 150 mm to about 180 mm, preferably from about 100 mm to about 200 mm.

[0040] As shown in FIG. 9, the needle 40 may further include a needle lumen 48 defined by a needle body 42 and extending along the entire length L1 between a proximal end 44 and a distal end 46. The needle lumen 48 may have a circular cross-section. The needle 40 can define a central axis 49 along which the needle lumen 48 extends. The central axis 49 can be parallel to a first direction D1. The needle 40 defines a gauge determined by the size of the needle lumen 48, specifically by a cross-sectional area J1 that is perpendicular to the first direction D1. The lumen 48 of the needle 40 is about 0.05 mm 2 to about 0.8 mm 2 or about 0.2 mm 2 to about 0.45 mm 2 and can define a cross-sectional area. The needle 40 can be a 20-gauge needle to a 25-gauge needle. According to another aspect, the needle 40 can be larger than a 20-gauge needle, for example, if the needle 40 is configured to be used within a blood vessel larger than the blood vessels typically found in the umbilical cord. In some aspects, the needle 40 can be solid and have no needle lumen 48. In some exemplary embodiments, the needle 40 can be a 20-gauge needle having an outer diameter of about 0.603 mm.

[0041] Still referring to FIG. 9, the needle 40 may include a bleedback reduction mechanism 45 configured to provide a restriction to blood flow through the needle lumen 48 while still allowing some amount of blood flow, which can be used to identify when the needle 40 enters a blood vessel. According to one embodiment, the needle 40 may include a micropore 47 that is smaller than the needle lumen 48. The bleedback reduction mechanism 45 may be positioned within the needle lumen 48, for example, in or near the distal end 46, in or near the proximal end 44, or between the distal end 46 and the proximal end 44. A portion of the bleedback reduction mechanism 45 may be positioned outside the needle lumen 48, for example, around the outside of the proximal end 44. In some exemplary embodiments, the bleedback reduction mechanism 45 may be in liquid communication with the flashback chamber 231, and blood is configured to move through the needle 40 and specifically through the bleedback reduction mechanism 45 and into the flashback chamber 231. The liquid can enter the flashback chamber 231 by passing through the micropore 47 as described above. In one embodiment, the bleedback reduction mechanism 45 effectively reduces the inner diameter of the needle lumen 48. In some aspects, the bleedback reduction mechanism 45 may include features on the needle 40 configured to locally reduce the inner diameter of the needle lumen 48 to define the micropore 47.

[0042] As shown in FIG. 9, the tip of the needle 40 can include a bevel 64 having a base end 65 and a tip end 66. As the bevel 64 extends from the base end 65 to the tip end 66, the cross-sectional area J1 decreases. The needle 40 can define a bevel angle α measured from the central axis 49 to the bevel 64. According to one embodiment, the bevel angle α can be from about 1° to about 60°. According to another embodiment, the bevel angle α can be from about 5° to about 45°. According to yet another embodiment, the bevel angle α can be from about 10° to about 25°. According to yet another embodiment, the bevel angle α can be from about 12° to about 22°. The smaller the bevel angle α, the easier it can be to puncture the blood vessel and insert the needle 40. However, reducing the bevel angle α increases the length of the bevel 64 measured from the base end 65 to the tip end 66. According to one aspect of the present disclosure, the needle 40 can include a plurality of bevels, and the bevel 64 is one of the plurality of bevels. The needle can be manufactured from a medical grade material such as surgical stainless steel, for example SAE 316, 420, or 440 stainless steel.

[0043] According to one embodiment, the success of the insertion of the needle 40 is achieved when both the tip end 66 and the base end 65 are positioned inside the blood vessel. As the length of the bevel 64 increases, the insertion depth of the needle 40 required to successfully insert can become deeper, thereby increasing the likelihood of "backwalling" or puncturing through the blood vessel. Thus, according to one embodiment, the needle 40 is configured to maintain a balance of ease of insertion into the umbilical cord while minimizing the likelihood of umbilical cord backwalling.

[0044] Referring again to FIGS. 1-7A, as shown in one aspect, the cannula insertion device 20 includes a mechanism for translating the needle 40 relative to the housing 220. A needle actuator 50 is connected to or disposed on the housing 220 (see particularly FIGS. 6-7). In some aspects, the needle actuator 50 can move within the recess 222. The needle actuator 50 is operably coupled to the needle assembly 22 (see FIG. 8), and when the needle actuator 50 is actuated, the needle 40 moves from a first position to a second position. Referring to FIGS. 4-7, the needle actuator 50 is attached to a hub 52 and a boom arm 54 disposed between the needle actuator 50 and the hub 52. The hub 52 can include a recess 56 configured to receive the needle 40. The recess 56 defines a shape corresponding to the outer surface 59 of the needle body 42. The needle assembly 22 can be configured such that the needle 40 is permanently or temporarily fixed to the hub 52. For example, the needle 40 and the hub 52 can be fixed by an adhesive, overmolding, welding, corresponding threads, etc.

[0045] According to one embodiment, the needle 40 and the needle actuator 50 are configured to be fixed, and movement including translational movement, rotation, or both of the needle 40 relative to the hub 52 is prevented without plastic deformation of the needle assembly 22.

[0046] The boom arm 54 extends, as shown in the illustrated embodiment, from the hub 52 to the needle actuator 50, for example, at least partially in the distal direction DD. The boom arm 54 can include a proximal end 55 adjacent to the hub 52 and a distal end 57, and the distal end 57 is on the opposite side of the proximal end 55 and is positioned such that the distal end 57 of the boom arm 54 terminates at the needle actuator 50. The needle actuator 50 can include an actuation surface 58 configured for user contact. As shown in FIG. 6, the actuation surface 58 can face in a second direction D2. In other aspects, the actuation surface 58 can be oblique or perpendicular to the second direction D2. The user can push the actuation surface 58, for example, with a finger or thumb, such that the needle actuator 50 moves the needle 40.

[0047] As can be seen in FIGS. 6 and 6A, the needle actuator 50 can include a stop surface 60 positioned adjacent to, for example, the distal end portion 57. According to one embodiment, the stop surface 60 faces in the proximal direction PD. The stop surface 60 is configured to selectively abut against another surface of the cannula insertion device 20, such as a block surface 124 defined by the housing 220. FIG. 6 shows the stop surface 60 abutting against the block surface 124, and FIG. 6A shows the stop surface 60 spaced apart from the block surface 124.

[0048] The needle assembly 22 can further include a biasing member 62, such as a spring or a resilient elastic cord (see FIGS. 5 and 5A). The biasing member 62 is configured to apply a biasing force to the needle assembly 22. According to one embodiment, the biasing member 62 is configured to apply a force to the hub 52 in the proximal direction PD.

[0049] The needle assembly 22 can have a loaded configuration and an unloaded configuration. In the loaded configuration, the needle 40 is in a first position and the biasing member 62 is exerting a biasing force on the hub 52 in the proximal direction PD. The boom arm 54 can be held in a predetermined position against the biasing force by contact between the stop surface 60 and the block surface 124, which serves as a physical stop to prevent the needle assembly 22 from being moved by the biasing member 62 (see FIGS. 6 and 6A). It will be appreciated that the force exerted by the biasing member 62 is sufficient to move the needle assembly 22 in the absence of resistance to the movement of the needle assembly 22, but is insufficient to cause deformation or damage to any of the boom arm 54, the hub 52, the needle 40, or the housing 220 if the biasing force remains unchanged due to the engagement between the stop surface 60 and the block surface 124.

[0050] In the no-load configuration, the stop surface 60 is not in contact with the block surface 124, and the needle assembly 22 is positioned more proximally than when in the load configuration. To transition the needle assembly 22 from the no-load configuration to the load configuration, the needle assembly 22 is moved in the distal direction DD against the biasing force exerted on the needle assembly 22 by the biasing member 62, as described below. This transition can be actuated manually by the user. The user can apply a force to the needle assembly 22 (e.g., in the flashback chamber 231) and push the needle assembly 22 in the distal direction DD. In some embodiments, the housing 220 may have an open proximal end 221, and the user can insert a finger or thumb into the housing 220 and contact the flashback chamber 231. It will be appreciated that the force applied by the user must be greater than the biasing force exerted by the biasing member 62. In some embodiments, the user can apply a loading force by pushing the flashback chamber 231 in the distal direction DD. When the needle assembly 22 is in the load configuration, the user can hear an audible click sound indicating the successful transition of the needle assembly 22 from the no-load configuration to the load configuration.

[0051] In the load configuration, the needle assembly 22 is configured such that when the user contacts (e.g., presses) the actuation surface 58, the distal end 57 of the needle actuator 50 moves relative to the hub 52. This movement can cause the boom arm 54 to elastically deform. For example, as shown in FIGS. 18A and 18B, the user input can include an actuation force F applied to the actuation surface 58 in a third direction D3. The third direction D3 can be opposite to the second direction D2, perpendicular to the actuation surface 58, both, or neither. The boom arm 54 can be moved, for example, in the third direction D3, by applying a force to the actuation surface 58, and the stop surface 60 is disengaged from the block surface 124. Without this engagement, the needle assembly 22 moves in the proximal direction PD by the biasing force. The needle 40 is in a first position inside the cannula insertion device 20 (FIGS. 18A and 18D) when the stop surface 60 and the block surface 124 are engaged, and is in a second position (FIGS. 18B and 18E) when the stop surface 60 and the block surface 124 are not engaged and the needle assembly 22 is moved in the proximal direction PD by the biasing force exerted on the hub 52 by the biasing member 62 such that the stop surface 60 is positioned proximal to the block surface 124.

[0052] Referring to FIGS. 10 - 12, the cannula insertion system may further include an expander assembly 25. In one embodiment, the expander assembly 25 functions to receive the needle 40 and create a larger opening in the blood vessel after the needle has pierced the wall of the blood vessel. Expanding the opening in the blood vessel can assist in inserting the cannula into the blood vessel, as further described below. The expander assembly 25 includes an expander 26, an expander hub 246 configured to fixedly hold the expander 26 therein, and an expander movement mechanism 240. Referring particularly to FIG. 12, the expander 26 may include a distal end 90, a proximal end 92, and an expander body 94 extending from the proximal end 92 to the distal end 90. The expander 26 further includes an expander lumen 96 defined by the expander body 94. As shown in the illustrated embodiment, the expander lumen 96 can extend through the entire expander body 94 between the proximal end 92 and the distal end 90. The expander lumen 96 has a cross - sectional area slightly larger than the outer surface area of the needle 40 and is configured to receive the needle 40 therein. The needle 40 can move slidably within the expander lumen 96 and can extend at least partially from the distal end 90 of the expander lumen 96, from the proximal end 92 of the expander lumen 96, or from both ends of the expander lumen 96. In some aspects, the needle 40 may be longer than the expander 26.

[0053] The expander body 94 may define a tapered portion 98 adjacent to the distal end 90. The expander 26 can define an outer cross - sectional area J2, which decreases as the tapered portion 98 extends in the distal direction DD. As shown in the illustrated embodiment, the minimum cross - sectional area J2 of the tapered portion 98 can be located at the distal end 90 of the expander 26. In some aspects, the expander 26 can have an outer diameter 91 of from about 2 mm to about 6 mm. In some exemplary aspects (see FIG. 12B), the expander 26 can have an outer diameter 91 of from about 4 mm to about 5 mm. In other exemplary aspects (see FIG. 12A), the expander 26 can have an outer diameter 91 of from about 2 mm to about 3 mm. It will be appreciated that the specific size of the expander 26 depends on its intended use with the cannula insertion system 10. In some aspects, the specific expander 26 used depends on the vascular structure of the umbilical cord.

[0054] The tapered portion 98 may have a specific length 93 measured from the distal end portion 90 to the beginning portion of the taper located at a position on the expander body 94 where the outer cross-sectional area J2 begins to decrease compared to the outer cross-sectional area J2 of the remainder of the expander body 94. In some embodiments, the length 93 of the tapered portion 98 can be about 1 mm to about 12 mm, about 2 mm to about 11 mm, about 3 mm to about 10 mm, about 4 mm to about 9 mm, or another suitable length. In some exemplary embodiments (see FIG. 12A), the length 93 of the tapered portion 98 can be about 4 mm. In other exemplary embodiments (see FIG. 12B), the length 93 of the tapered portion 98 can be about 9 mm.

[0055] The tapered portion 98 may have an inner diameter 95 that is different from the inner diameter of the remainder of the expander body 94 that is not the tapered portion 98, or, alternatively, the inner diameter 95 can be the same throughout the expander body 94 including the tapered portion 98. In some exemplary embodiments, the inner diameter 95 of the tapered portion 98 can be about 0.5 mm to about 2 mm. In some specific exemplary embodiments, the inner diameter 95 of the tapered portion 98 can be about 0.96 mm.

[0056] The dilator 26 can be sized and shaped according to the specific aspects described above, based on the intended application in the cannula insertion system 10. Since the cannula insertion system 10 can be utilized to insert a cannula into an arterial or venous blood vessel, various parameters of the dilator 26 may be preferred. For example, in an aspect where the cannula insertion system 10 is used to insert a cannula into an arterial blood vessel, it may be preferred to utilize a dilator that is smaller than a dilator used to insert a cannula into a venous blood vessel. In some aspects, when the cannula insertion system 10 is intended to insert a cannula into an arterial blood vessel, the dilator 26 may have a tapered portion 98 having a length 93 of about 4 mm (see, e.g., FIG. 12A). The dilator 26 can be sized from about 3 Fr to about 17 Fr, from about 5 Fr to about 15 Fr, or another suitable size range. The size of the dilator can be determined relative to the size of the cannula 104. In some aspects, the dilator can be sized 3, 4, 5, …, 17 Fr, or another suitable size. In some exemplary aspects, when the cannula insertion system 10 is intended to insert a cannula into an arterial blood vessel, the dilator 26 can be from about 4 Fr to about 11 Fr. In other aspects, when the cannula insertion system 10 is intended to insert a cannula into a venous blood vessel, the dilator 26 may have a tapered portion 98 having a length 93 of about 9 mm (see, e.g., FIG. 12B). The dilator 26 in these embodiments can be from about 9 Fr to about 17 Fr. The differences in the size and geometric profile of the dilator tip make it desirable to insert the dilator into the blood vessel and also reduce the risk of inadvertently puncturing the opposite blood vessel wall.

[0057] Referring to FIGS. 10 and 11, the expander 26 can be translated linearly by an expander movement mechanism 240 that includes an expander actuator 242 disposed on or within the housing 220. When the expander actuator 242 is moved in a first direction, the expander hub 246 and the expander 26 therein are moved, for example, in the distal direction DD, toward the blood vessel into which the cannula is to be inserted. When the expander actuator 242 is moved in a second, opposite direction, the expander hub 246 and the expander 26 therein are moved away from the blood vessel, for example, in the proximal direction PD. In some embodiments, when the expander actuator 242 moves, the expander hub 246 and the expander 26 move in opposite directions. For example, when the expander actuator 242 is moved in the distal direction DD, the expander 26 moves in the proximal direction PD, and when the expander actuator 242 is moved in the proximal direction PD, the expander 26 moves in the distal direction DD.

[0058] In some embodiments, the expander movement mechanism 240 further includes a rack and pinion gear system 260 that is disposed within the housing 220 and configured to engage and operate with the expander hub 246. A first pinion 262 is disposed on the housing 220 and is rotatable about its axis. The first pinion 262 is configured to engage a first rack 264 and move the first rack 264 along a first direction D1. A second pinion 266 is disposed on the housing 220 and is rotatable about its axis. The second pinion 266 is configured to engage a second rack 268 and move the second rack 268 along the first direction D1. In some embodiments, the first pinion 262 can be attached to the second pinion 266 such that when one of the pinions rotates, the other pinion also rotates. It will be appreciated that the rack and pinion gear system 260 can include a single pinion that engages both racks, or alternatively, can include more than two pinions and more than two racks.

[0059] Referring to FIGS. 18A-18F, the position of the expander 26 along the first direction D1 can be controlled, for example, also by the movement of the expander actuator 242 along the first direction D1. When the expander actuator 242 is in the first position, for example, its proximal-most position, the expander 26 is in its intended configuration, for example, its distal-most position (FIGS. 18A and 18B). As the expander actuator 242 is moved in the distal direction DD, the expander 26 can move in the proximal direction PD by the rack and pinion gear system 260 within the expander movement mechanism 240 described above (FIGS. 18C and 18F). The movement of the expander hub 246 and the expander 26 can also cause the movement of the needle assembly 22 (along with the needles) in the proximal direction PD (FIGS. 18C and 18F). As best seen in FIGS. 5 and 5A, the needle hub 52 can contact the expander hub 246 such that when the expander hub 246 moves in the distal direction DD or the proximal direction PD, the needle hub 52 also moves in the same respective direction. For example, as shown in FIG. 18C, both the expander hub 246 and the needle hub 52 are more proximal than their respective positions in FIG. 18B.

[0060] As shown in FIGS. 10 to 11B, the expander assembly 25 may include a holding member 241 disposed thereon, for example, on the expander movement mechanism 240. The holding member 241 is elastically deformable, for example, in a second direction D2 or a third direction D3. Referring to FIGS. 11A and 11B, the holding member 241 is releasably engaged with a corresponding expander assembly block surface 225 defined on the housing 220 to prevent the expander assembly 25 from accidentally moving. The holding member 241 defines a holding surface 243 configured to contact the expander assembly block surface 225. For example, when the expander assembly 25 is arranged such that the expander 26 is in its intended configuration (such as in FIGS. 18A and 18B), the holding member 241 is inside the housing 220, for example, in the recess 222, and the holding surface 243 is not in contact with the housing 220 (see FIG. 11A). When the expander assembly 25 is moved such that the expander 26 is in its retracted configuration (such as that seen in FIG. 18C), the holding member 241 moves out of the recess 220, and the holding surface 243 is positioned in line with the expander assembly block surface 225 along a first direction D1 (see FIG. 11B). If, after the expander 26 has been retracted, the user attempts to move the expander actuator 242 rearward in the opposite direction, the holding surface 243 contacts the expander assembly block surface 225, preventing such movement. This prevents the expander 26 from accidentally extending after it has already been retracted. If such movement is still desired, or if the cannula insertion process is complete, the expander assembly 25 may be returned to its original position, where the expander 26 is extended by applying a force (for example, pushing down) to the holding member 241 in a third direction D3 such that, as the expander actuator 242 is moved in a proximal direction PD, the holding surface 243 no longer aligns with the expander assembly block surface 225 along the first direction D1.

[0061] The cannula insertion system 10 may further include a cannula system 28, which is configured to be fluidly connected to a blood vessel into which the cannula is to be inserted at one end and to a circulation system at the other end. Referring to FIGS. 13 to 17A, the cannula system 28 may include a cannula 104 having a distal end 100 and a proximal end 102 opposite the distal end 100. The cannula 104 includes a cannula lumen 106 defined by the cannula 104. As shown in the illustrated embodiment, the cannula lumen 106 can enter the cannula 104 at one of the proximal end 102 and the distal end 100, extend through the entire cannula 104, and exit the cannula 104 at the other of the proximal end 102 and the distal end 100.

[0062] The cannula 104 may define a tapered portion 108 adjacent to the distal end 100. The cannula system 28 can define a cross-sectional area J3 (see FIG. 17), which decreases as the tapered portion 108 extends in the distal direction DD. The minimum cross-sectional area J3 of the tapered portion 108 may be located at the distal end 100 of the cannula system 28.

[0063] The cannula 104 may define a reinforcing portion 110 configured to resist deformation. The reinforcing portion 110 may be adjacent to the distal end 100. The reinforcing portion 110 may include a component configured to resist stretching, such as a polyethylene wire or thread or a stainless steel wire. Thereby, when the cannula 104 is inserted into a blood vessel and the clamping mechanism is activated to fix the blood vessel to the cannula system 28, the reinforcing portion 110 is prevented from being stretched. The reinforcing portion 110 may be part of the cannula 104 or may constitute the entire cannula 104 between the distal end 100 and the proximal end 102. The reinforcing portion 110 may include one or more materials that resist stretching, such as nitinol, stainless steel, a polyaramid synthetic mesh such as KEVLAR® (available from E.I. Du Pont de Nemours and Company, Wilmington, Delaware), high modulus polyethylene (such as DYNEEMA®), or other suitable materials. Thus, the cannula 104 is less flexible near its distal end 100 and can increase rigidity near the blood vessel. Thus, in one embodiment, the distal 25%, more preferably 50%, of the cannula 104 is less flexible than the remaining proximal portion of the cannula 104.

[0064] In some embodiments, the dilator 26 and the cannula 104 can be a single component having a tapered distal end. The inner diameter of the tapered distal end may be approximately the same as or nominally larger than the outer diameter of the needle body 42, and the needle body 42 may be disposed within the tapered distal end. The tapered distal end of the combined dilator and cannula component in such an embodiment may be configured to be deformable and, when the combined dilator and cannula component is disposed within the blood vessel, the tapered end may be expanded to create a bore having a substantially constant inner diameter along its length. It will be appreciated that this combined component can provide functionality comparable to that of the separate dilator 26 and cannula 104 as described throughout this application.

[0065] The cannula system 28 can include a Y-connector 190 configured to connect to the cannula 104. The Y-connector divides the cannula system 28 into two proximal portions. The first proximal portion 194 defines a first proximal channel 206 that extends therethrough and is configured to be interlocked with and connected to the cannula insertion device 20. The second proximal portion 196 defines a second proximal channel 208 that extends therethrough and is configured to connect to one or more components of an external circulation circuit 400 (see FIG. 25), such as an extracorporeal membrane oxygenation (ECMO) system. The second proximal portion 196 can be connected to a tube 28b, which can then be connected to the external circulation circuit 400. The distal portion 192 of the Y-connector 190 defines a distal channel 210, which is disposed opposite the first proximal portion 194 and the second proximal portion 196 and communicates with the cannula 104, for example, at the proximal end 102. The distal channel 210 is in fluid communication with the cannula lumen 106 and also with the second proximal channel 208. The fluid communication between the distal channel 210 and the first proximal channel 206 is reversible and can be opened or closed during use. FIG. 14 depicts an embodiment in which the second proximal channel 208 is coaxial with the cannula lumen 106, but in other embodiments, the first proximal channel 206 can be arranged to be coaxial with the cannula lumen 106. Also, the needle 40 and the dilator 26 can be sufficiently flexible (e.g., elastically flexible) to bend along the insertion path from the first proximal channel 206 to the cannula lumen 106.

[0066] The Y-connector 190 may be a separate component from the cannula 104, or, in some embodiments, the Y-connector 190 and the cannula 104 may be formed as a monolithic integral part. When a Y-shaped connector is utilized, the needle 40 and the dilator 26 are introduced through a first channel, and the fluid (e.g., blood) from the cannula-inserted blood vessel moves through a different channel. This prevents blood loss, leakage, infections, or damage to the cannula system 28 or any connected tubing. This further facilitates the transition between the cannula insertion process and flowing blood through the cannula, and at least a portion of the assembly is connected to an external flow circuit during the cannula insertion process. In some embodiments, at least a portion of the Y-connector 190 may include a reinforcing portion 110.

[0067] In some embodiments, the entire cannula 104, the Y-connector 190, and the tube 28b can be a single integral part molded (e.g., dip molded) as one component. Such an integral construction can be beneficial to blood health by removing transition sections along the blood flow path, thereby reducing instances of blood clot formation, leakage, or bacterial growth sites. The Y-connector 190 can include one or more materials that resist stretching, such as nitinol, stainless steel, polyaramid synthetic mesh, such as KEVLAR® (available from E.I. Du Pont de Nemours and Company, Wilmington, Delaware), high modulus polyethylene (e.g., DYNEEMA®), or other suitable materials. Specifically, in some embodiments, the distal portion 192 may include the stretching-resistant material listed above, and the first proximal portion 194 and the second proximal portion 196 may not include the stretching-resistant material.

[0068] The first proximal portion 194 defines a seal 198 (see FIG. 15), and the needle 40 and / or the dilator 26 can removably pass through the seal 198 when the cannula insertion device 20 is engaged with the cannula system 28. It will be appreciated that the seal 198 is configured to open reversibly to allow the needle 40 and the dilator 26 to pass through, and to close when the needle 40 and the dilator 26 are removed from the cannula system 28. The seal 198 may comprise an elastic or resilient material configured to deform in response to the force of the needle 40 or the dilator 26 and return to its undeformed state when the needle 40 or the dilator 26 is removed. The seal 198 must be manufactured such that passage of liquid within the cannula is prevented when the seal 198 is closed. When the seal 198 is open, the distal channel 210 can be in fluid communication with both the first proximal channel 206 and the second proximal channel 208. When the seal 198 is closed, the distal channel 210 can communicate with only the second proximal channel 208. In some embodiments, the seal 198 can be a slit seal 198 in the wall of the Y-connector 190 within the first proximal portion 194. In some embodiments, the seal 198 can be a septum seal in the wall of the Y-connector 190 within the first proximal portion 194 configured to be penetrated by the needle 40 and the dilator 26.

[0069] A rigid casing 200 can be disposed on the Y-connector 190 to provide structure to the Y-connector 190. The casing 200 can be of any suitable shape, such as a Y-shape that complements the shape of the Y-connector 190. The casing 200 can be an integral part, or in some aspects, can include separate components, such as a first casing component disposed on the first proximal portion 194 and a second casing component disposed on the second proximal portion 196. The rigid casing 200 can be formed of a plastic such as polycarbonate.

[0070] For example, as shown in FIG. 13, the rigid casing 200 may include a locking component 202 disposed on the rigid casing for releasably engaging the cannula system 28 with the cannula insertion device 20. The cannula insertion device 20 includes complementary locking components 224 (see FIGS. 6 and 7), which interact with the locking component 202 to releasably lock the cannula system 28 to the housing 220 of the cannula insertion device 20 and are configured to prevent accidental movement, separation, relative translational movement, or relative rotation. The locking components 202, 224 can be any suitable locking mechanism, such as a protrusion, rail, hook, latch, or another mechanism. The locking engagement can be reversed to disconnect the cannula system 28 from the cannula insertion device 20.

[0071] Referring again to FIGS. 1 - 7A showing the cannula insertion device 20, a release mechanism 226 can be disposed on the housing 220 of the cannula insertion device 20 and configured to actuate the movement of the locking component 224 on the housing 220. When the locking component 224 on the housing 220 is moved, it is disengaged from the locking component 202 on the casing 200, and thus the cannula system 28 can be removed from the cannula insertion device 20. The release mechanism 226 can be a button, switch, latch, or another suitable mechanism. In some embodiments, a second release mechanism 226b can be disposed on the housing. The second release mechanism 226b can be used if the primary release mechanism 226 fails to fully disengage the components or if another emergency situation occurs.

[0072] In some embodiments, the casing 200 may further include a guide 270 over one or both of the first proximal portion 194 and the second proximal portion 196 (see, e.g., FIGS. 13-15). The guide 270 corresponds to the shape of the recess 222 such that the cannula system 28 can be inserted therein only in a desired orientation. For example, the guide 270 may be disposed over the second proximal portion 196, which cannot be inadvertently inserted into the recess 222 or engaged with the needle assembly 22 or the dilator 26. This prevents user error, reduces the likelihood of damaging the cannula system 28 or the cannula insertion device 20, and prevents incorrect connections that could result in improper blood circulation, blood loss, air bubble entry, or leakage.

[0073] In some embodiments, once the cannula 104 is inserted into a blood vessel, it is advantageous to secure the blood vessel into which the cannula is inserted to the cannula 104. A clamp mechanism can be used to releasably secure the cannula 104 to the blood vessel. It will be appreciated that the cannula 104 can be secured by indirectly contacting the blood vessel, for example, a portion of the umbilical cord. In some embodiments, the clamp mechanism can contact the umbilical cord sheath, Wharton's jelly within the umbilical cord, or the blood vessel itself. In some embodiments, the clamp mechanism is attached to the cannula system 28, or specifically to the cannula 104. Referring again to FIGS. 13 - 17A, one or more collet jaws 170 can be disposed on or adjacent to the cannula 104. The collet jaw 170 can include a base 172 (seen in FIG. 14) to which the collet jaw 170 is attached to the cannula 104, a head 174 on the opposite side of the base 172, and a deformable arm 176 extending between the base 172 and the head 174. The deformable arm 176 can be curved, and when the base 172 is attached to and contacts the cannula 104, the head 174 is spaced apart from the cannula 104. In this arrangement, the collet jaw 170 is biased open. In some embodiments, the collet jaw 170 can be formed from titanium. In other embodiments, the collet jaw 170 can be formed from stainless steel, such as 306 stainless steel or 316 stainless steel.

[0074] As depicted in the exemplary embodiment of FIG. 17, during engagement, the deformable arm 176 can be bent and straightened along its length, and the head 174 is moved towards the cannula 104. A portion of the blood vessel 2 into which the cannula has been inserted (shown in a perspective view) can be disposed between the cannula 104 and the head 174. When the deformable arm 176 is bent towards the cannula 104, the inner wall of the blood vessel 2 is pressed against the outer surface of the cannula 104 by the inner surface of the head 174. Thereby, the blood vessel 2 is fixed in place relative to the cannula 104. As described above, it will be understood that the head 174 can press the blood vessel 2 against the cannula 104 by pushing against another portion of the umbilical cord 1, such as the umbilical cord sheath, rather than directly contacting the blood vessel 2.

[0075] Still referring to FIGS. 13 - 17A, in some embodiments, the bending of the deformable arm 176 can be actuated by a collet sleeve 178 configured to slide along the cannula 104. The deformable arm 176 can be disposed between the cannula 104 and the collet sleeve 178. When the collet sleeve 178 is moved towards the distal end 100, it slides over the deformable arm 176, applying a force thereto to deform and straighten the deformable arm 176. The force applied by the collet sleeve 178 must be greater than the inherent resistance to bending in the deformable arm 176. When the collet sleeve 178 is moved away from the distal end 100, the force on the deformable arm 176 is removed and the deformable arm returns to its non-deformed configuration. In some embodiments, a physical stop 180 can extend from a portion of the collet jaw 170 to prevent the collet sleeve 178 from passing beyond the physical stop. In some embodiments, the stop 180 can be disposed on the head 174, on the deformable arm 176, on the base 172, or on the cannula 104.

[0076] The collet jaw 170 includes features that facilitate holding a blood vessel into which a cannula has been inserted. In some aspects, one or more teeth 182 (see FIGS. 16 and 17) may be disposed on the head 174 such that when the collet sleeve 178 deforms the deformable arm 176 to bring the head 174 into contact with the blood vessel, the teeth 182 bite into, pierce, or grip the umbilical cord 1. The teeth 182 may bite into the umbilical cord sheath of the umbilical cord, the blood vessel itself, or other connective tissue present within the umbilical cord. It will be appreciated that the teeth 182 need not bite into or completely penetrate and grip the umbilical cord. Such gripping or biting in further secures the blood vessel such that, for example, when the cannula 104 is inserted into the blood vessel and secured to the tissue and then pulled in the proximal direction PD, the blood vessel is prevented from translating or rotating relative to the collet jaw 170 or the cannula 104. In some aspects, the teeth 182 may be substantially orthogonal to the head 174 or, alternatively, may be disposed at an angle to the head 174, for example, and the teeth 182 extend away from the head 174 in a direction away from the distal end 100 of the cannula 104. The teeth 182 bite into the tissue (e.g., umbilical cord sheath) surrounding the blood vessel 2 or the blood vessel 2 itself and can prevent the blood vessel 2 from moving or being pulled away from the cannula system 28 during the cannula insertion process or subsequent use. The exemplary aspects herein are directed to blood vessels within the umbilical cord, but it will be understood that the disclosed system may be utilized in other parts of the human or other animal body. It will further be appreciated that "tissue" may refer to umbilical cord tissue or other physiological tissue including organs.

[0077] In some embodiments, it may be preferable to fix the blood vessel 2 as close as possible to the distal end 100 of the cannula 104, reducing the space between the distal end 100 and the portion of the blood vessel 2 fixed to the cannula system 28. This reduces the collection of blood in that space, reducing the swelling of the blood vessel 2 where blood accumulates between the distal end 100 and the portion of the blood vessel 2 fixed, increasing the pressure and stretching and expanding the blood vessel. This can lead to undesirable separation of the blood vessel 2 from the cannula system 28, as well as blood stasis, blood clotting, infections, insufficient blood flow, blood loss, and / or leakage. FIG. 16 depicts the collet jaw 170 in the unlocked position, where the head 174 is spaced from the cannula 104, and FIG. 17 depicts the collet jaw 170 in the locked position, where the head 174 clamps the blood vessel 2 to the cannula 104 between the head 174 and the cannula 104. The collet jaw 170 can have one, two, three, four, or another suitable number of deformable arms 176 and respective heads 174. In some exemplary embodiments, the collet jaw 170 has two deformable arms 176 and respective heads 174. It will be understood that the collet jaw 170 can be used to apply a clamping action to the blood vessel 2 by clamping the external tissue (e.g., umbilical cord or Wharton's jelly) around the blood vessel 2, without the need to directly clamp the blood vessel wall.

[0078] In some embodiments, the spring lock 179 may be disposed on the deformable arm 176 (see FIG. 17A). The spring lock 179 is compressed and held by the collet sleeve 178 when the collet jaw 170 is in the unlocked configuration. When the collet sleeve 178 is moved in the distal direction DD to deform the deformable arm 176 to secure the cannula 104 to the blood vessel 2, the collet sleeve 178 passes across the spring lock 179, returning the spring lock 179 to its uncompressed state. The spring lock 179 is then positioned proximal to the collet sleeve 178 (not shown) and acts as a physical barrier to prevent the collet sleeve 178 from moving in the proximal direction PD. The spring lock 179 can be returned to the compressed configuration by pushing it toward the cannula 104 and sliding the collet sleeve 178 back in the proximal direction PD over the spring lock 179. For example, if it is necessary to remove the cannula 104 from the blood vessel, moving the spring lock 179 and sliding the collet sleeve 178 back resets the cannula insertion device 20 to disengage the collet jaw 170 from the tissue.

[0079] The housing 220 may include a mechanism for moving the collet jaw 170. In some aspects, this mechanism may be part of or connected to the expander actuator 242 described above. Referring again to FIGS. 1-7A, the expander actuator 242 disposed on the housing 220 is movable relative to the housing 220 in a distal direction DD and a proximal direction PD and can move the collet jaw 170. When the expander actuator 242 is moved in the distal direction DD, the collet jaw 170 can move from an unlocked position where the blood vessel 2 is not fixed between the collet jaw 170 and the cannula system 28 to a locked position where the blood vessel 2 is fixed between the collet jaw 170 and the cannula system 28. The expander actuator 242 may be configured to contact the collet sleeve 178, and when the expander actuator 242 moves, the collet sleeve 178 moves. The collet sleeve 178 may also be moved from the locked position to the unlocked position, and this movement can be achieved by moving the expander actuator 242 in the direction opposite to that described above or, alternatively, by manually moving the collet sleeve 178 (i.e., the user moves the collet sleeve 178).

[0080] In some embodiments, the collet sleeve 178 may include a handle 184, which can be gripped, pushed, or pulled to translate the collet sleeve 178. In some embodiments, the dilator actuator 242 may be attached to the collet sleeve 178 and configured to contact and move the handle 184 (see FIGS. 13-15). In some embodiments, the dilator actuator 242 includes a collet engagement surface 252 configured to contact the handle 184 (see, e.g., FIGS. 1, 2, 6, and 7). The collet engagement surface 252 may also serve as a block surface to prevent the handle 184 from moving extremely proximally in the proximal direction PD. The reinforcement portion 110 can prevent stretching when the collet sleeve 178 is moved along the cannula 104, which helps maintain the desired size and shape of the cannula system 28 and reduces the possibility of components being damaged or accidentally disengaging.

[0081] The collet jaw 170 may be disposed on or adjacent to the reinforcement portion 110 of the cannula system 28. When the collet jaw 170 is in the closed position and the blood vessel 2 is fixed to the cannula system 28, the clamping force applied to the cannula system 28 through the blood vessel 2 by the collet jaw 170 does not deform the reinforcement portion 110 of the cannula system 28. According to one aspect of the present disclosure, the reinforcement portion 110 is configured to receive the collet jaw 170 and maintain a cylindrical shape.

[0082] A method of assembling the cannula insertion system 10 may include coupling the needle 40 to the needle actuator 50 such that at least one (or both) of the needle 40 and the needle actuator 50 is locked against translational movement and locked against rotational movement. The step of coupling the needle 40 to the needle actuator 50 may include positioning at least a portion of the needle 40 within the recess 56 of the hub 52. The step of coupling the needle 40 to the needle actuator 50 may further include securing at least a portion of the needle 40 within the recess 56. The step of securing at least a portion of the needle 40 within the recess 56 may include using an adhesive, overmolding, welding, threading, etc.

[0083] A method of assembling the cannula insertion system 10 may include coupling the dilator 26 to the dilator hub 246, wherein the dilator 26 and the dilator hub 246 are locked against at least one of translational movement and rotational movement. The step of securing at least a portion of the dilator 26 to the dilator hub 246 may include using an adhesive, overmolding, welding, threading, etc.

[0084] A method of assembling the cannula insertion system 10 may include coupling the needle 40, the needle actuator 50, the dilator 26, the dilator actuator 242, and the housing 220 such that the needle 40 and the needle actuator 50 are translatable with respect to both the dilator 26 and the housing 220. According to one aspect of the present disclosure, the step of coupling the needle 40, the needle actuator 50, the dilator 26, the dilator actuator 242, and the housing 220 is performed after the step of coupling the needle 40 to the needle actuator 50 and after the step of coupling the dilator 26 to the dilator hub 246. The step of coupling the needle 40, the needle actuator 50, the dilator 26, the dilator actuator 242, and the housing 220 may include inserting the needle 40 into the dilator lumen 96 and translating the needle 40 in the distal direction DD with respect to the dilator 26 within the dilator lumen 96.

[0085] A method of assembling the cannula insertion system 10 may include, for example, the step of compressing the biasing member 62 in an embodiment where the biasing member 62 is a compressible spring or elastic element.

[0086] A method of assembling the cannula insertion system 10 may include the step of preventing movement of the needle assembly 22 relative to the housing 220 in the proximal direction PD. According to one aspect of the present disclosure, this step may include the step of bringing the stop surface 60 into contact with the blocking surface 124 as described above. This step may be performed by applying a force to the needle assembly 22 in the distal direction DD. The flashback chamber 231 can be pushed by the user to move the needle assembly 22 in the distal direction DD.

[0087] The method of assembly may include the step of connecting the cannula system 28 to the housing 220. According to one aspect of the present disclosure, the step of connecting the cannula system 28 to the housing 220 may include the step of connecting the cannula system 28 to the housing 220 such that movement of the housing 220 relative to the cannula system 28 in the distal direction DD is blocked and movement of the housing 220 relative to the cannula system 28 in the proximal direction PD is not blocked. According to one aspect of the present disclosure, the step of connecting the cannula system 28 to the housing 220 may include the step of connecting the cannula system 28 to the housing 220 such that movement of the housing 220 relative to the cannula system 28 in both the distal direction DD and the proximal direction PD is blocked. The step of connecting the cannula system 28 to the housing 220 may include inserting the dilator 26 into the cannula lumen 106 and translating the dilator 26 in the distal direction DD relative to the cannula system 28 within the cannula lumen 106.

[0088] The step of connecting the cannula system 28 to the housing 220 may include the step of orienting the cannula system 28 so that it can be inserted into the recess 222 of the housing. In some embodiments, if a particular orientation of the cannula system 28 relative to the housing 220 is desired, this step may further include the step of aligning the guide 270 with an opening within the recess 222 defined, for example, by the shape of the housing 220, such that the cannula system 28 can enter into the recess 222.

[0089] The method of assembly may also include the step of engaging a first proximal portion 194 of the Y-connector 190 with the housing 220. The needle 40, the dilator 26, or both may be inserted into the first proximal channel 206, through a seal 198 (e.g., a slit seal 198), into the distal channel 210, and into the cannula lumen 106. In some embodiments, the method of assembly may further include the step of engaging the casing 200 with the housing 220 such that the cannula system 28 is prevented from translating or rotating relative to the housing. In some embodiments where the casing 200 includes one or more locking components 202 and the housing includes complementary locking components 224, the step of engaging the casing 200 with the housing 220 may further include the step of securing the locking components 202 on the casing 200 with the respective corresponding locking components 224 on the housing 220 to lock the cannula system 28 to the housing 220. In some embodiments, engaging the locking components 202 with the locking components 224 may produce an audible click sound, thus providing the user with an auditory feedback that the connection action has been successfully completed.

[0090] The cannula system 28 can be primed with the required liquid and be ready to be connected to a blood vessel. The method of assembly may further include the step of priming the cannula system 28. The step of priming the cannula system 28 may include introducing into the cannula 104 a solution having a composition that mimics the concentration, weight osmolarity, and pH of blood, plasma, saline, PlasmaLyte, and / or human physiological plasma electrolytes. The one or more liquids introduced may be brought to or maintained at the desired temperature, pressure, and gas concentration. It will be appreciated that the specific values of the aforementioned parameters will depend on the specific requirements of the intended application. The step of priming may include removing air bubbles from the cannula 104 so that the cannula 104 is completely filled with liquid.

[0091] After the method of assembling the cannula insertion system 10 is completed, the cannula insertion device 20 and the cannula system 28 may define an assembled configuration, such as shown in FIGS. 1 and 2, for example. According to one aspect of the present disclosure, in the assembled configuration: 1) the needle 40 is coupled to the needle actuator 50 such that the needle 40 and the needle actuator 50 are locked in translational movement; 2) the dilator 26 and the housing 220 are coupled such that the dilator 26 and the housing 220 are locked in translational movement; 3) the needle assembly 22 is coupled to the dilator such that the needle assembly 22 is translatable relative to the dilator 26; 4) the cannula system 28 is coupled to the housing 220 such that the cannula system 28 is translatable relative to the housing 220 in the distal direction DD and the cannula system 28 is locked in translational movement relative to the housing 220 in the proximal direction PD.

[0092] After the desired use, the method may further include the step of separating the cannula system 28 from the housing 220. The separating step may include actuating the release mechanism 226 to disengage the locking component 202 on the casing 200 from the corresponding locking component 224 on the housing 220. In some embodiments, the method may include an alternative step of separating the cannula system 28 from the housing 220 by actuating a second release mechanism 226b instead of the primary release mechanism 226. This may be done, for example, in an emergency situation if the release mechanism 226 fails to or is unable to separate the cannula system 28 from the housing 220. In some embodiments, actuating the release mechanism 226 or the second release mechanism 226b produces an audible click sound, thus providing the user with an auditory feedback that the separation action has been successfully completed. After disengaging the locking components 202, 224 from each other, the cannula system 28 can be removed from the recess 222 and out of the housing 220. The needle 40 can be removed from the cannula lumen 106, pulled through the seal 198, and out of the first proximal channel 206. The dilator 26 can be removed from the cannula lumen 106, pulled through the seal 198, and out of the first proximal channel 206.

[0093] In some embodiments, the assembling method may further include the step of inserting the attachment component 212 into the first proximal channel 206 (see FIGS. 13 and 15 showing the attachment component 212 and FIG. 14 showing the first proximal channel 206). The attachment component 212 can be a cap or plug for preventing blood from flowing out of the first proximal channel 206. In some embodiments, the first proximal portion 194 may include a seal element 204 configured to engage with the attachment component 212 to create a liquid-tight seal between the attachment component 212 and the first proximal portion 194. The seal element 204 can be a cross-slit seal. The seal element 204 and the attachment component 212 together can form a liquid-tight seal. The seal 198 and the seal formed between the seal element 204 and the attachment component 212 help prevent liquid from entering the first proximal channel 206 from the cannula lumen 106 or debris from entering the cannula lumen 106 from the first proximal channel 206 after the cannula insertion process is completed.

[0094] The cannula insertion device 20 can be configured in an assembled configuration such that the housing 220 abuts against the cannula system 28 and movement of the housing 220 relative to the cannula system 28 in a third direction D3 is prevented.

[0095] The assembled configuration of the cannula insertion system 10 can include an extended configuration (such as shown in FIGS. 18A and 18D) in which the needle 40 and the dilator 26 extend in the distal direction DD. The assembled configuration can further include a first retracted configuration (FIGS. 18B and 18E) in which the needle 40 is in the retracted position as described above and the dilator 26 is in the extended position. The assembled configuration can further include a second retracted configuration (FIGS. 18C and 18F) in which both the needle 40 and the dilator 26 are in the retracted positions as described above.

[0096] In the first and second retracted configurations, the distal end 46 of the needle 40 is positioned within the dilator lumen 96, and the distal end 46 of the needle 40 is positioned proximal to the distal end 90 of the dilator 26. According to one aspect of the present disclosure, the cannula insertion system 10 is configured such that a user can shift the cannula insertion system 10 from the extended configuration to the first retracted configuration and from the first retracted configuration to the extended configuration with one hand. The user can further shift the cannula insertion system 10 from the first retracted configuration to the second retracted configuration and from the second retracted configuration to the first retracted configuration with one hand. By being configured to be shiftable with one hand, the cannula insertion system 10 allows the user's other hand to remain free to hold, for example, the umbilical cord during the insertion procedure.

[0097] In the first and second retracted configurations, the stop surface 60 may be spaced from the block surface 124. In these retracted configurations, the biasing force applied by the biasing member 62 resists movement of the needle 40 in the distal direction DD relative to the housing 220. Applying a force to the cannula insertion device 20 that is greater than the biasing force applied by the biasing member 62 in a direction opposite to the direction of the biasing force causes the needle 40 to move in the distal direction DD relative to the housing 220, thereby allowing the cannula insertion device 20 to be shifted from the retracted configuration to the extended configuration.

[0098] In the extended configuration, the distal end 46 of the needle 40 is positioned outside the dilator lumen 96, and the distal end 46 of the needle 40 is positioned distal to the distal end 90 of the dilator 26. In the extended configuration, the stop surface 60 abuts the block surface 124 of the housing 220, and movement of the needle 40 in the proximal direction PD relative to the housing 220 is prevented by interference between the stop surface 60 and the block surface 124.

[0099] According to one aspect of the present disclosure, the cannula insertion system 10 can be assembled and transported to the operating room in a retracted configuration. In the first or second retracted configuration, the distal end 46 of the needle 40 is surrounded by the dilator 26, thus reducing the possibility of damage to the distal end 46 of the needle 40 and also reducing the possibility of injury to the user of the cannula insertion system 10 by the sharp distal end 46 of the needle 40. Alternatively, the cannula insertion system 10 may be presented to the user such that the cannula system 28 is separated from the cannula insertion device 20. In some aspects, the cannula system 28 can be primed before being engaged with the cannula insertion device 20 as described above. In some aspects, the cannula insertion device 20 can be delivered to the user in a first retracted configuration where the dilator 26 is in the extended position, the needle 40 is in the retracted position, and the needle tip 66 is inside the dilator lumen 96.

[0100] The method of use may include the step of moving the cannula insertion device 20 from a first retracted configuration to an extended configuration. The user can apply a loading force to the needle assembly 22 to move the needle 40 in the distal direction DD until the distal end 46 of the needle 40 moves outside the dilator lumen 96 and is positioned distal to the distal end 90 of the dilator 26 along the first direction D1, and until the stop surface 60 on the needle actuator 50 is positioned distal to the block surface 124 along the first direction D1. For example, in some exemplary embodiments, the user can apply a force to the flashback chamber 231 or the plug 233. As described above, in some aspects, the housing 220 may have an open proximal end 221 and the user can insert a finger or thumb into the housing 220. To apply a force to the flashback chamber 231 or the plug 233, the user can insert one or more fingers into the housing 220 (e.g., into the portion of the housing 220 that includes the translucent portion 230) and push the flashback chamber 231. The applied force must be greater than the force applied in the opposite proximal direction PD by the biasing member 62. The biasing member 62 can be compressed or extended. When the needle actuator 50 passes beyond the block surface 124 in the distal direction DD, the distal end 57 of the boom arm 54 and the needle actuator 50 move in the second direction D2, thereby aligning the stop surface 60 and the block surface 124 along the first direction D1. The user can stop pushing the needle assembly 22 after the stop surface 60 has been moved into alignment with the block surface 124. In this position, the cannula insertion device 20 is in the extended configuration (Figures 18A and 18D). In some aspects, the user may receive an indication, such as an audible click or a tactile feedback, that the cannula insertion device 20 is in the appropriate extended configuration.

[0101] The needle actuator 50, and in particular the boom arm 54, can be formed of a deformable yet elastic or resilient material, such that the boom arm 54 can be deformed when a force is applied, but can also return to its undeformed state when the force is removed. When a force F is applied to the actuating surface 58 at the distal end 57 of the needle actuator 50, the boom arm 54 is deformed, for example, in a third direction D3 that is opposite to a second direction D2. When this force is removed, the boom arm 54, which is biased to return to its undeformed state, moves the distal end 57, and the attached needle actuator 50, in the second direction D2.

[0102] The method of use can include advancing the cannula insertion device 20 toward a blood vessel 2, such as a blood vessel within the umbilical cord, while the needle 40 is in an extended configuration in which the distal end 46 (i.e., the needle tip) extends distally beyond the distal end 90 of the dilator 26. Referring to FIG. 19, the method of use can further include puncturing the first wall 4 of the blood vessel 2 with the distal end 46 of the needle 40. As shown, the assembled configuration of the cannula insertion device 20 can include the needle 40 being "tilted downward" such that the tip 66 is spaced distally from the base end 65 in a second direction D2, and the tip 66 is closer to the actuating surface 58 with respect to the second direction D2 than the base end 65 is away from the actuating surface 58 with respect to the second direction D2. Alternatively, the cannula insertion system 10 can include the needle being "tilted upward" (opposite to tilting downward) when the cannula insertion device 20 is in the assembled configuration. Alternatively, the cannula insertion system 10 can include the needle being oriented in a direction that is neither tilted upward nor tilted downward when the cannula insertion device 20 is in the assembled configuration.

[0103] As shown, the step of making a hole in the first wall 4 of the blood vessel 2 includes orienting the cannula insertion device 20 with respect to the blood vessel 2 such that the angle β measured from the central axis 49 of the needle 40 to the first wall 4 of the blood vessel 2 is about 5° to about 60°, about 10° to about 45°, or about 15° to about 30°. The cannula insertion device 20 can define a length L2 measured along a first direction D1 from the base end 65 to the distal end 90 of the dilator 26. According to one aspect of the present disclosure, the length L2 can be about 1.5 mm to about 2 mm. Alternatively, the length L2 can be less than 1.5 mm or greater than 2 mm such that the cannula insertion device 20 can be configured for blood vessels of various sizes. The cannula insertion device 20 can be configured such that the length L2 is large enough to allow insertion of the entire bevel 64 into the blood vessel while minimizing the possibility of a back wall of the blood vessel 2. It will be appreciated that the insertion angle of the needle 40 can vary greatly from application to application. For example, blood vessels within the umbilical cord can be oriented in a variety of different ways and thus require various insertion angles. Some exemplary and non-limiting examples of such blood vessels are shown in FIGS. 24A and 24B. FIG. 24A depicts, for example, the step of inserting a cannula into an arterial blood vessel, and FIG. 24B depicts the step of inserting a cannula into a venous blood vessel. It will be understood that these figures are pictorial depictions and do not show all of the components involved in the cannula insertion process. Despite the specific insertion angle, the cannula insertion process for each blood vessel is preferably performed such that the blood vessel can be properly secured to the cannula 104 without damaging the blood vessel itself.

[0104] The method of use can further include advancing the cannula insertion device 20 in a distal direction DD with respect to the blood vessel 2 until both the distal end 66 of the needle 40 and the base end 65 of the needle 40 are positioned inside the blood vessel 2. The method of use can further include stopping the movement of the cannula insertion device 20 in the distal direction DD with respect to the blood vessel 2 before the distal end 66 of the needle 40 makes a hole in the second wall 6 of the blood vessel 2.

[0105] The method of use may include advancing the cannula insertion device 20 in the distal direction DD with respect to the blood vessel 2 until the tip 66 of the needle 40, the base end 65 of the needle 40, and the distal end 90 of the dilator 26 are each positioned within the blood vessel 2. The step of advancing the cannula insertion device 20 in the distal direction DD with respect to the blood vessel 2 until the tip 66 of the needle 40, the base end 65 of the needle 40, and the distal end 90 of the dilator 26 are each positioned within the blood vessel 2 may include inserting at least a portion of the tapered portion 98 of the dilator 26 into the blood vessel 2. Next, as shown in FIG. 20, the needle 40 may then be retracted, and the tip 66 of the needle 40 will be more proximal relative to the distal end 90 of the dilator 26.

[0106] After at least a portion of the tapered portion 98 of the dilator 26 is positioned within the blood vessel 2, the method of use may include retracting the needle 40. The step of retracting the needle 40 may include moving the needle 40 in the proximal direction PD with respect to the blood vessel 2. According to one aspect of the present disclosure, the step of retracting the needle 40 includes moving the needle 40 in the proximal direction PD until the needle 40 is no longer positioned within the blood vessel 2. The step of retracting the needle 40 may be performed while maintaining the relative position between the dilator 26 and the blood vessel 2.

[0107] According to one aspect of the present disclosure, the step of retracting the needle 40 includes moving the needle actuator 50, for example, by depressing the actuation surface 58 using a finger. The user may push the actuation surface 58 in a direction, for example, a third direction D3, etc., a direction towards the needle 40. The force exerted on the actuation surface 58 needs to be greater than the inherent resistance to bending from the boom arm 54 itself and large enough to temporarily deform the boom arm 54 and move the distal end 57 towards the needle. According to one aspect of the present disclosure, the boom arm 54 may be designed in a bent shape, and the boom arm 54 provides its own biasing mechanism. In some embodiments where an additional biasing force is applied to the boom arm 54, the force exerted on the actuation surface 58 must be greater than those biasing forces.

[0108] The step of retracting the needle 40 may include sliding the stop surface 60 along the block surface 124, for example in a third direction D3, until the stop surface 60 and the block surface 124 are no longer aligned along the first direction D1. Once the stop surface 60 and the block surface 124 are no longer aligned along the first direction D1, the force applied by the biasing member 62 (see, e.g., FIG. 18B) moves the needle actuator 50, boom arm 54, hub 52, and attached needle 40 in a proximal direction PD relative to the housing 220. In some embodiments, the step of retracting the needle 40 may produce an audible click sound, thus providing the user with an auditory feedback that the needle retraction has been successfully completed.

[0109] Referring to FIG. 21, the method of use may include advancing the cannula insertion device 20 in a distal direction DD relative to the blood vessel 2 until both the distal end 90 of the dilator 26 and the distal end 100 of the cannula system 28 are positioned within the blood vessel 2. As shown in the illustrated embodiment, the step of advancing the cannula insertion device 20 itself may include inserting at least a portion of the tapered portion 108 of the cannula system 28 into the blood vessel 2.

[0110] According to one embodiment, the step of advancing the cannula insertion device 20 in a distal direction DD relative to the blood vessel 2 until both the distal end 90 of the dilator 26 and the distal end of the cannula 100 are positioned within the blood vessel 2 is performed after the step of retracting the needle 40. This step may include inserting the entire tapered portion 108 of the cannula system 28 into the blood vessel 2.

[0111] The method of use may include the step of retracting the dilator 26. The step of retracting the dilator 26 may include the step of moving the dilator 26 in the proximal direction PD with respect to the blood vessel 2. According to one aspect of the present disclosure, the step of retracting the dilator 6 includes the step of moving the dilator 26 in the proximal direction PD until the dilator 26 is no longer located inside the blood vessel 2. The step of retracting the dilator 26 may be performed while maintaining the relative position of the cannula system 28 and the blood vessel 2. According to one aspect of the present disclosure, the step of retracting the dilator 26 is performed after the step of advancing the cannula insertion device 20 in the distal direction DD with respect to the blood vessel 2 until both the distal end 90 of the dilator 26 and at least the distal end 100 of the cannula are positioned inside the blood vessel 2.

[0112] The step of retracting the dilator 26 may include the step of applying a force to the dilator actuator 242 to move the dilator actuator 242 along a first direction D1. The dilator actuator 242 may be connected to a rack and pinion gear system 260.

[0113] In some embodiments, the step of moving the expander actuator 242 may include the step of moving the expander actuator 242 in the distal direction DD. As a result, the second rack 268, which engages with the second pinion 266, can also move in the distal direction DD. The second pinion 266 may be fixed to the housing 220, and the second pinion 266 can rotate, but is prevented from translating along the first direction D1. When the second rack 268 moves, the second pinion 266 rotates. In some embodiments, the second pinion 266 is connected to the first pinion 262, and when the second pinion 266 rotates, the first pinion 262 also rotates. When the second pinion 266 rotates, the first pinion 262 rotates, causing movement of the first rack 264 engaged with the first pinion 262. Due to such rotation, the first rack 264 can move in the proximal direction PD. The expander assembly 25 and the expander 26 may be connected to the first rack 264, and when the first rack 264 moves in the proximal direction PD, the expander 26 also moves in the proximal direction PD. In some embodiments, the step of retracting the expander 26 may produce an audible click sound, thus providing the user with an auditory feedback that the expander retraction has been successfully completed. The cannula insertion device 20, with both the needle 40 and the expander 26 in the retracted position, is depicted in FIG. 18C.

[0114] The method of use may include the step of fixing the position of the cannula system 28 relative to the blood vessel 2. For example, the cannula 104 may be clamped to the blood vessel 2. In some embodiments, one or more collet jaws 170, as described above, may be disposed on the cannula system 28 to fix the cannula 104 to the blood vessel 2.

[0115] The method of use may include the step of moving the collet jaw 170 from an unlocked position where the blood vessel 2 is not fixed between the collet jaw 170 and the cannula 104 (see FIG. 16 showing the blood vessel 2 in a perspective view) to a locked position where the blood vessel 2 is fixed between the collet jaw 170 and the cannula 104 (see FIG. 17 showing the blood vessel 2 in a perspective view). The step of moving the collet jaw 170 to the locked position may include the step of moving the collet sleeve 178 in the distal direction DD toward the distal end portion 100 of the cannula 104. The collet sleeve 178 slides over the deformable arm 176, deforming the deformable arm 176, and the head 174 is moved toward the cannula 104. The farther the collet sleeve 178 is moved distally in the distal direction DD, the closer the head 174 approaches the cannula 104. The portion of the blood vessel 2 to be fixed may be positioned between the cannula 104 and the head 174. When the collet sleeve 178 is moved in the distal direction DD, the head 174 contacts the blood vessel 2 and compresses the blood vessel 2 between the head 174 and the cannula 104 (see FIG. 17).

[0116] The step of moving the collet sleeve 178 may include the step of moving the collet handle 184. The handle 184 may be attached to the collet sleeve 178, and when the handle 184 is moved in the distal direction DD, the collet sleeve 178 is also moved in the distal direction DD.

[0117] The step of moving the collet handle 184 may include the step of moving the dilator actuator 242 in the distal direction DD until the collet engagement surface 252 contacts the handle 184, and the step of pushing the handle 184 in the distal direction DD with the collet engagement surface 252.

[0118] In some alternative embodiments, the step of clamping the blood vessel 2 may be performed by a blood vessel clamp configured as a clip that is operated by pinching with one hand to fix a thin and slippery umbilical blood vessel to the cannula.

[0119] The step of fixing the position of the cannula system 28 relative to the blood vessel 2 may include the step of suturing the cannula 104 to the blood vessel 2. According to one embodiment, the suture may be wound around the reinforcing portion 110 of the cannula 104.

[0120] The step of fixing the position of the cannula system 28 relative to the blood vessel 2 may be performed after the step of retracting the dilator 26.

[0121] The method of use may also include the step of separating the cannula system 28 from the cannula insertion device 20 as described above. The separating step may include actuating the release mechanism 226 to disengage the locking component 202 on the casing 200 from the corresponding locking component 224 on the housing 220. In some aspects, the method may include an alternative step of separating the cannula system 28 from the housing 220 by actuating a second release mechanism 226b instead of the primary release mechanism 226. This may be done if the release mechanism 226 is not sufficient to separate the cannula system 28 from the housing 220 or in other emergency situations. In some aspects, actuating the release mechanism 226 or the second release mechanism 226b produces an audible click sound, thus providing the user with auditory feedback that the separation action has been successfully completed.

[0122] The method of use may further include the step of attaching the attachment component 212 to the first proximal portion 194 after the cannula system 28 is detached from the cannula insertion device 20. The attachment component 212 can be a trocar valve or a cross-slit valve and can be moved through the seal element 204 to prevent blood from passing out of the first proximal channel 206. The attachment component 212 can also move the liquid between the seal 198 and the seal element 204 and can prevent additional liquid from entering the space between the two seals. By moving (or removing) the liquid between the seal 198 and the seal element 204, stagnant blood or priming fluid is removed. The attachment component 212 can also provide a physical barrier adjacent to the seal 198 to prevent the seal 198 from opening due to the pressure within the cannula lumen 106. In some embodiments, the attachment component 212 can be fastened to the rigid casing 200 or the cannula 104.

[0123] The cannula insertion system 10 may be part of a kit that includes one or more cannula insertion devices 20, one or more cannula systems 28, one or more needle assemblies 22, one or more dilator assemblies 25, or any combination thereof. The method of use may include repeating any of the steps described above an additional two times, with three of the cannula insertion systems 10 being used to create access, for example, to three blood vessels 2. According to one aspect of the present disclosure, the three blood vessels may include one vein and two arteries, and the vein and the two arteries are located within the umbilical cord of a neonate. The blood vessels within the umbilical cord may have various sizes, and thus it will be appreciated that appropriate sized components of the disclosed systems should be used with each blood vessel. The method of use may include securing each cannula system 28 of the cannula insertion devices 20 relative to one another, movement of any one of the cannula systems 28 relative to any of the other cannula insertion systems 28. The step of securing the cannula 104 may include winding a suture around each of the cannulas 104. The step of securing the cannula 104 allows each of the cannula systems 28 to remain aligned with their respective blood vessels 2 and reduces rubbing and friction between the cannula systems 28 and their respective blood vessels 2.

[0124] According to one aspect of the present disclosure, the cannula insertion system 10 may include a wrapping, tape, suture, or another structure configured to fix the cannulas 104 of the plurality of cannula insertion devices 20 to each other after the cannulas 104 are inserted into their respective blood vessels. According to one aspect of the present disclosure, the cannula insertion system 10 may include cannulas 104 of various sizes. It will be appreciated that the size of the cannula 104 may depend on the intended application of that cannula 104. For example, the size of the cannula 104 may be determined based on which particular blood vessel the cannula is inserted into. In some exemplary aspects, the cannula 104 may have a size in the range of about 4Fr to about 18Fr. The cannula 104 may be 4Fr, 5Fr, 6Fr, …, 18Fr, or another size suitable for the intended use. In some exemplary applications where a plurality of cannulas 104 may be introduced into blood vessels of different sizes, the separate cannulas 104 may have various sizes. For example, in an aspect where the cannula 104 is introduced into a first type of blood vessel (e.g., the umbilical artery), the cannula 104 may be about 5Fr to about 12Fr, and when the cannula 104 is introduced into a second type of blood vessel (e.g., the umbilical vein), the cannula 104 may be about 12Fr to about 18Fr.

[0125] Figure 22 depicts an exemplary process 300 for inserting a cannula into a blood vessel 2. In step 302, the cannula insertion system 10 is positioned relative to the blood vessel 2 such that the needle 40 is at the desired angle and location to pierce the blood vessel 2. It will be appreciated that other surgical preparation steps, such as disinfecting, cleaning, or otherwise preparing the blood vessel 2, or priming the cannula system 28, may be performed either before or after step 302.

[0126] In step 304, the cannula insertion device 20 is moved towards blood vessel 2 such that the needle 40 pierces the wall of blood vessel 2. It will be appreciated that the needle 40 is of a suitable size and rigidity to pierce the desired blood vessel. After the needle 40 has pierced the wall of blood vessel 2, blood from blood vessel 2 can flow through the cannula insertion system 10 and exit into the flashback chamber 231 through the opening 232. The blood can pool within the recess 222 of the housing 220, and the user can visually detect the presence of blood within the recess 222 by looking through the translucent portion 230 or through the open proximal end 223 of the housing 220. This can indicate to the user that the blood vessel 2 has been successfully pierced.

[0127] In step 306, after piercing blood vessel 2, the dilator 26 enters blood vessel 2 through the opening created by the needle 40 in step 304. The dilator 26 moves translationally into the blood vessel 2 to expand the opening in the wall of the blood vessel 2.

[0128] In step 308, the needle 40 can be retracted according to the mechanisms described throughout this specification. This removes the sharp needle tip from inside blood vessel 2 and reduces the potential for backwalling or otherwise puncturing, scratching, or irritating the blood vessel wall. Also, this increases the space within blood vessel 2 such that the dilator 26 can enter into that space and further expand the opening in the blood vessel wall.

[0129] In step 310, the dilator 26 can be retracted as described throughout this specification. Retraction of the dilator 26 creates a larger space inside blood vessel 2 for the cannula 104 and also increases the open space inside the cannula lumen 106, allowing more blood to flow from blood vessel 2 into the cannula system 28.

[0130] In step 312, the tip of the cannula 104 enters the blood vessel 2 through the enlarged hole in the vessel wall. The entry of the cannula 104 can be facilitated by the tapered portion 108 at the distal end 100 of the cannula 104. The blood in the blood vessel 2 can now flow into the cannula lumen 106. The blood can flow through the cannula lumen 106, through the second proximal portion 196 of the Y-connector 190, and through the tube 28b that is connected to (or is part of) the cannula system 28.

[0131] In step 314, the cannula 104 can be fixed to the blood vessel 2 to prevent the separation of the blood vessel and the cannula. The step of fixing the cannula 104 to the blood vessel 2 can be achieved by moving one or more collet jaws 170 from the unlocked position to the locked position, as described throughout this specification. Specifically, this step can include moving the collet sleeve 178, deforming the deformable arm 176, and moving the head 174 towards the cannula 104 and the blood vessel 2 between the cannula 104 and the head 174. This step can further include the step of piercing the wall of the blood vessel 2 with one or more teeth 182.

[0132] It will be appreciated that some of the steps of the process 300 can be performed in a different order. For example, in some embodiments, the step 310 of retracting the dilator 26 can be performed after the step 312 of inserting the cannula 104 into the blood vessel 2.

[0133] Process 300 may further include the optional step of connecting cannula system 28 to an external circulation circuit 400 (see, e.g., FIG. 25), e.g., an extracorporeal membrane oxygenation circuit. In some embodiments, this connection may be made at the second proximal portion 196 of Y-connector 190. In some embodiments, an intermediate tube 28b may be connected to the second proximal portion 196, which may then be connected to the external circulation system. The step of connecting cannula system 28 to the external circulation system may be performed before step 302, and cannula system 28 may already be connected to the external circulation system when the cannula is inserted into blood vessel 2.

[0134] Process 300 may further include the step of introducing a liquid into flushback chamber 231. The user may inject a liquid through opening 232 into flushback chamber 231. This step may include moving plug 233 out of opening 232 before injecting the liquid through opening 232.

[0135] Process 300 may include the step of visually observing whether blood or a priming fluid drips from opening 232 into flushback chamber 231 when the needle is retracted to confirm whether needle 40 is properly inserted into blood vessel 2. This step may be performed immediately after step 308.

[0136] In some embodiments, process 300 may further include the optional step of disconnecting cannula system 28 from cannula insertion device 20 after fixing cannula 104 to blood vessel 2. This step may include disengaging a lock component 202 on cannula system 28 from a corresponding lock component 224 on cannula insertion device 20, as described throughout this specification. The step of disconnecting cannula system 28 from cannula insertion device 20 may further include moving needle 40 and dilator 26 through seal 198 such that no component is inserted into seal 198 anymore and thus the seal closes to prevent liquid from passing through it.

[0137] In some embodiments, process 300 may further include the optional step of inserting attachment component 212 into first proximal channel 206 of first proximal portion 194, moving the liquid present within first proximal channel 206, and preventing liquid or debris from entering first proximal channel 206.

[0138] As referred to throughout this application, cannula system 28 may fluidly connect a neonate to an extracorporeal circuit. The extracorporeal circuit may include an oxygenator configured to provide gas exchange for blood passing therethrough. It will be appreciated that the extracorporeal circuit may also include other components that help maintain the blood passing through the circuit at suitable parameters.

[0139] In some embodiments, the cannula insertion process 300 can be performed on multiple blood vessels to define a blood circuit between separate blood vessels (e.g., cannula insertion into an arterial blood vessel and cannula insertion into a venous blood vessel). When a cannula is inserted into a first blood vessel through which blood flows into the cannula system 28 from the first blood vessel, the blood flows through the cannula lumen 106 and into the second proximal portion 196 of the Y-connector 190 and then into the tube 28b. The blood can then move through an external circulation circuit (including one or more components for treating the blood, such as an oxygenation device). After the blood is treated by any of the components within the external circulation circuit, the blood can flow into the tube 28b of the second cannula system 28 that can be connected to a second blood vessel and flow through it. The blood can then flow from the tube 28b of the second cannula system 28 into the second proximal portion 196 and also through the cannula lumen 106 of the second cannula system 28. From the second cannula system 28, the blood can move to the second blood vessel into which the cannula was inserted by the process 300. By inserting cannulas into at least the first blood vessel and the second blood vessel such that the cannula system 28 connected to the first blood vessel and the cannula system 28 connected to the second blood vessel are in fluid communication with each other, the user can create a blood circuit between the first blood vessel and the second blood vessel. In such an exemplary arrangement, the blood can flow out of the first blood vessel, move through the external circulation circuit, and flow into the second blood vessel. It will be appreciated that multiple first blood vessels (i.e., the blood vessels from which the blood flows out) and / or multiple second blood vessels (i.e., the blood vessels into which the blood flows) can have cannulas inserted and be connected to a single external circulation circuit.

[0140] The components of the various cannula insertion systems described throughout this specification can be manufactured from a variety of materials suitable for use in a medical environment, a surgical environment, or another aseptic environment. The cannula insertion device 20 and the cannula system 28 can include medical grade plastics or metals, or can have a combination of plastic components and metal components. Suitable materials include, but are not limited to, high density polyethylene (HDPE), polyetheretherketone (PEEK), polycarbonate, polyamide, polypropylene, polytetrafluoroethylene (PTFE), silicone, or another suitable one. The materials must be biocompatible and non-toxic, and must not react adversely with liquids, body fluids, gases, temperature, or the drugs being utilized. It will be understood that the cannula system 28, and any tubing used with the cannula system 28 (e.g., cannula 104 or tube 28b), must be non-hemolytic to avoid damage to the blood flowing therethrough. For example, in some aspects of the cannula insertion system 10, the needle 40 can be formed from stainless steel, the dilator 26 can be formed from HDPE, and the housing 220 can be formed from polycarbonate. The cannula 104 can be formed from urethane or silicone. The collet jaw 170 can be formed from titanium, or stainless steel, such as 304 stainless steel or 316 stainless steel.

[0141] It will be recognized that the foregoing description provides examples of the disclosed systems and techniques. However, it is contemplated that other embodiments of the present disclosure may differ in detail from the foregoing examples. All references to the present disclosure or its examples are intended to refer to the particular example being discussed at that time, and are not intended to further imply limitations with respect to the scope of the disclosure in general. All words of distinction and disparagement with respect to specific features are intended to indicate a lack of preference for those features, but are not intended to exclude them entirely from the scope of the disclosure unless otherwise expressly stated.

[0142] The description of a range of values in this specification is intended to serve only as a shorthand way of referring individually to each separate value that falls within the range, including the endpoints of the recited range, unless otherwise indicated herein. Each separate value is incorporated herein as if it were individually recited herein. All methods described herein can be performed in any suitable order, unless otherwise indicated herein or otherwise clearly contradicted by context.

[0143] While the present disclosure has been described in detail, it is to be understood that various changes, substitutions, and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims. Furthermore, the scope of the present disclosure is not intended to be limited to the specific embodiments described herein. As will be readily recognized by those of skill in the art, processes, machines, manufactures, compositions of matter, means, methods, or steps that presently exist or are later developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein can be utilized in accordance with the present disclosure.

[0144] 〔Embodiments〕 (1) A cannula insertion system for inserting a cannula into a blood vessel of a tissue, comprising a cannula system including a cannula defining a cannula lumen therethrough, the cannula having a distal end and a proximal end opposite the distal end, and a cannula insertion device configured to couple with the cannula system, the cannula insertion device including a dilator having a dilator body defining a dilator lumen therethrough, a needle having a needle body defining a needle lumen therethrough, the needle being translatable along a first direction within the dilator lumen, An expander actuator configured to be moved such that the movement of the expander actuator causes the movement of the expander along the first direction, and the expander actuator; A needle actuator configured to be moved such that the movement of the needle actuator causes the movement of the needle along the first direction, and the needle actuator; A housing that defines a housing recess therein, the housing recess being configured to receive the cannula system, the expander, and the needle, and the housing; A cannula insertion system, wherein the needle and the expander of the cannula insertion device are configured to be moved along the first direction inside the cannula lumen. (2) The cannula insertion system according to Embodiment 1, wherein the actuator is configured to translate the needle from a first position where the distal end of the needle is positioned distal to the distal end of the expander to a second position where the distal end of the needle is positioned proximal to the distal end of the expander. (3) The cannula system includes a Y-connector adjacent to the proximal end of the cannula, the Y-connector having a first proximal portion that defines a first proximal channel and a second proximal portion that defines a second proximal channel. The cannula insertion system according to Embodiment 1, wherein the first proximal channel and the second proximal channel are configured to be in fluid communication with the cannula lumen. (4) The first proximal portion defines a slit seal that separates the first proximal channel from the second proximal channel, the slit seal having an open configuration through which the expander and the needle are inserted and a closed configuration through which the needle and the expander do not extend. The cannula insertion system according to Embodiment 3, wherein when the slit seal is in the closed configuration, liquid from the cannula lumen is prevented from entering the first proximal channel. The cannula insertion system according to embodiment 3, further comprising a plug configured to be removably inserted into the first proximal channel.

[0145] (6) The cannula system further includes a locking element thereon, and the housing includes a locking element thereon, The locking element of the cannula system is configured to releasably engage with the locking element of the housing such that the cannula system is attached to the housing, the cannula insertion system according to embodiment 1. (7) The cannula insertion system further includes a collet jaw configured to releasably fix the cannula to the blood vessel, the collet jaw being attached to the cannula, the collet jaw having a base, deformable arms, and a head, When the collet jaw is in the open position, the head is spaced apart from the blood vessel and the cannula, and when the collet jaw is in the closed position, the head is in contact with the tissue and the blood vessel is held in place between the collet jaw and the cannula, the cannula insertion system according to embodiment 1. (8) The collet jaw further includes teeth on the head that extend towards the blood vessel, The teeth are configured to bite into the tissue when the collet jaw is in the second position, the cannula insertion system according to embodiment 7. (9) The housing includes a translucent portion configured to allow visibility into the housing recess through the housing, the cannula insertion system according to embodiment 1. (10) The cannula system is configured to be operatively connected to an extracorporeal membrane oxygenation (ECMO) system, the cannula insertion system according to embodiment 1.

[0146] (11) The tissue includes the umbilical cord of a neonate, the cannula insertion system according to embodiment 1. (12) A method of inserting a cannula into a blood vessel within a tissue, comprising: creating an opening in the wall of the blood vessel by moving a needle towards the blood vessel and through the wall of the blood vessel to create a hole in the wall at the distal end of the needle; inserting a dilator into the opening and expanding the opening; retracting the needle so that the needle exits the blood vessel; retracting the dilator so that the dilator exits the blood vessel; inserting a cannula into the opening in the wall of the blood vessel; fixing the cannula within the blood vessel, wherein the cannula defines a cannula lumen extending between a distal end and a proximal end and passing through the cannula, and wherein the dilator and the needle are capable of moving within the cannula lumen. (13) The needle defines a distal end and a proximal end opposite the distal end, the dilator defines a dilator lumen extending through the dilator between a distal end and a proximal end, wherein the step of retracting the needle comprises moving the needle within the dilator lumen from a first position where the distal end of the needle is outside the dilator lumen and distal to the distal end of the dilator to a second position where the distal end of the needle is within the dilator lumen and proximal to the distal end of the dilator, the method according to embodiment 12. (14) The step of fixing the cannula to the blood vessel comprises moving a collet jaw from an unlocked position where the collet jaw does not contact the tissue to a locked position where the collet jaw firmly clamps the tissue, the blood vessel is held between the collet jaw and the cannula, and at least a portion of the blood vessel is prevented from translating relative to the cannula, the method according to embodiment 12. (15) The method according to embodiment 14, further comprising the step of penetrating the tissue by teeth disposed on the collet jaw.

[0147] (16) The method according to embodiment 12, further comprising the step of connecting the cannula to an extracorporeal membrane oxygenation (ECMO) system. (17) The cannula is connected to a Y-connector that is divided into a first proximal portion and a second proximal portion separate from the first proximal portion, The step of connecting the cannula to the ECMO system includes the step of connecting the second proximal portion of the Y-connector to the ECMO system, the method according to embodiment 16. (18) The method according to embodiment 12, further comprising the step of withdrawing the dilator and the needle from the cannula lumen after the step of fixing the blood vessel to the cannula. (19) The cannula is connected to a Y-connector that is divided into a first proximal portion and a second proximal portion separate from the first proximal portion, The step of withdrawing the dilator and the needle from the cannula lumen includes the step of moving the dilator and the needle through the first proximal portion, the method according to embodiment 18. (20) The method according to embodiment 19, further comprising the step of moving the needle and the dilator through a slit seal defined in the first proximal portion of the Y-connector.

[0148] (21) The method according to embodiment 19, further comprising the step of inserting a plug into a first proximal channel of the Y-connector to prevent outflow of blood from the first proximal portion. (22) The tissue includes the umbilical cord of a neonate, the method according to embodiment 12. (23) A cannula system, A cannula having a distal end and a proximal end opposite the distal end, A cannula lumen extending through the cannula between the distal end and the proximal end, A slit seal disposed on the cannula, the slit seal being configured to receive a cannula insertion device, and the cannula system is a cannula system configured to be in fluid communication with a blood vessel and an oxygenation device. (24) The cannula has a Y-shaped connector having a first proximal portion and a second proximal portion, and further includes a slit seal disposed on the cannula, the slit seal being configured to receive a cannula insertion device therethrough, and the cannula lumen extends through the second proximal portion of the Y-shaped connector, the slit seal is configured to allow fluid communication between the first proximal portion and the cannula lumen, the cannula system according to embodiment 23. (25) The tissue includes a neonatal umbilical cord, the cannula system according to embodiment 23.

[0149] (26) A cannula for fluid communication with a blood vessel of a tissue, having a distal end, a proximal end opposite the distal end, a cannula lumen extending through the cannula between the distal end and the proximal end, a Y-shaped connector having a first proximal portion and a second proximal portion, and a slit seal disposed on the cannula, the slit seal being configured to receive a cannula insertion device therethrough, and the cannula lumen extends through the second proximal portion of the Y-shaped connector, the slit seal is configured to allow fluid communication between the first proximal portion and the cannula lumen, the cannula. (27) The tissue includes a neonatal umbilical cord, the cannula according to embodiment 26.

Claims

1. A cannula insertion system for inserting a cannula into a blood vessel of a tissue, comprising: A cannula system including a cannula that defines a cannula lumen therethrough, the cannula having a distal end and a proximal end opposite the distal end; A cannula insertion device configured to be coupled to the cannula system, the cannula insertion device including: An introducer having an introducer body that defines an introducer lumen therethrough; A needle that is translatable along a first direction within the introducer lumen; An introducer actuator configured to be moved such that movement of the introducer actuator causes movement of the introducer along the first direction; A needle actuator configured to be moved such that movement of the needle actuator causes movement of the needle along the first direction; A housing that defines an internal housing recess, the housing recess being configured to receive the cannula system, the introducer, and the needle; The cannula insertion system, wherein the needle and the introducer of the cannula insertion device are configured to be moved along the first direction within the cannula lumen.

2. The cannula insertion system according to claim 1, wherein the needle actuator is configured to translate the needle from a first position where a distal end of the needle is positioned distal to a distal end of the introducer to a second position where the distal end of the needle is positioned proximal to the distal end of the introducer.

3. The cannula system includes a Y-connector adjacent to the proximal end of the cannula, the Y-connector having a first proximal portion that defines a first proximal channel and a second proximal portion that defines a second proximal channel; The cannula insertion system according to claim 1, wherein the first proximal channel and the second proximal channel are configured to be in fluid communication with the cannula lumen.

4. The first proximal portion defines a slit seal that separates the first proximal channel from the second proximal channel, and the slit seal has an open configuration through which the dilator and the needle are inserted, and a closed configuration in which the needle and the dilator do not extend therethrough. The cannula insertion system according to claim 3, wherein when the slit seal is in the closed configuration, liquid from the cannula lumen is prevented from entering the first proximal channel.

5. The cannula insertion system according to claim 3, further comprising a plug configured to be removably inserted into the first proximal channel.

6. The cannula system further includes a locking element thereon, and the housing includes a locking element thereon. The cannula insertion system according to claim 1, wherein the locking element of the cannula system is configured to releasably engage the locking element of the housing such that the cannula system is attached to the housing.

7. The cannula insertion system according to claim 1, further comprising a collet jaw configured to releasably fix the cannula to the blood vessel, the collet jaw being attached to the cannula and having a base, deformable arms, and a head. When the collet jaw is in the open position, the head is spaced apart from the blood vessel and the cannula, and when the collet jaw is in the closed position, the head is in contact with the tissue and the blood vessel is held in place between the collet jaw and the cannula.

8. The collet jaw further includes teeth on the head that extend toward the blood vessel. The cannula insertion system according to claim 7, wherein the teeth are configured to bite into the tissue when the collet jaw is in the closed position.

9. The cannula insertion system according to claim 1, wherein the housing includes a translucent portion configured to allow visibility into the housing recess through the housing.

10. The cannula insertion system according to claim 1, wherein the cannula system is configured to be operatively connected to an extracorporeal membrane oxygenation (ECMO) system.

11. The tissue is the cannula insertion system according to claim 1, including the umbilical cord of a newborn.

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