Cannulation system comprising a shapable tip

Abstract

A cannula system for intubating a blood vessel has a cannula having a distal end and a proximal end. The cannula defines a cannula lumen. The cannula system also includes a tip on the distal end of the cannula. The tip defines a tip lumen connected to the cannula lumen. The tip is changeable between a first shape and a second shape. The first shape has a first width dimensioned to fit through a lumen of a blood vessel. The second shape has a second width that is greater than the first width and is sized to engage the vascular lumen and secure the tip in position within the vascular lumen.

Description

Background Technology

[0001] In the United States, extreme preterm birth is a leading cause of infant morbidity and mortality in children under five years of age, accounting for more than one-third of infant deaths and half of cerebral palsy diagnoses. Respiratory failure is the most common and challenging problem associated with extreme preterm birth, as gas exchange in severely preterm newborns is impaired due to the structural and functional immaturity of their lungs. Advances in neonatal intensive care have improved survival rates and extended the developmental limits of preterm newborns from approximately 23 weeks of gestation to approximately 24 weeks, marking the transition of lung development from the tubular to the cystic stage. Despite improved survival, the incidence of chronic lung disease and other organ immaturity complications remains high, particularly in newborns born before 28 weeks of gestation. Developing a system that can support normal growth and organ maturation in newborns, even for just a few weeks, could significantly reduce morbidity and mortality in extremely preterm infants and improve the quality of life for survivors.

[0002] Cannulation systems facilitate the insertion of cannulas, arteries, and other vessels into patients, such as newborns. A cannulation system typically consists of a cannula or needle for puncturing the patient's body and a cannula for insertion into the patient's body via the puncture. Additionally, some cannulation systems may include a dilator for positioning the cannula. The needle and dilator must be inserted into the cannula from a proximal position to allow for precise extension through the cannula tip. In use, the needle is used to penetrate the vessel wall and advance until the dilator tip passes through the opening. The needle is then withdrawn, and the dilator is further advanced until the cannula reaches the appropriate depth within the vessel, at which point the dilator is withdrawn again. Simultaneously with the dilator withdrawal, a device must be engaged with the vessel to secure the cannula. The dilator must then be removed from the cannula to open the blood flow. The relatively large outer diameter of the dilator necessitates a large opening on the side of the cannula to allow the dilator to enter and exit the cannula lumen. Furthermore, the securing device is complex and therefore occupies a significant amount of space around or inside the cannula. As a result, the vessel may be over-occupied and stretched. In addition, there is a need to make the attachment between the cannula and the dissected blood vessel more secure. Summary of the Invention

[0003] This disclosure addresses this need by providing a cannula with a shape-adjustable distal end. Therefore, in one aspect, this document provides a cannulation system for cannulating a blood vessel. The cannulation system includes a cannula having a distal end and a proximal end. The cannula defines a cannula lumen. The cannulation system also includes a distal end at the distal end of the cannula. The distal end defines a distal lumen connected to the cannula lumen. The distal end is variable between a first shape and a second shape. The first shape has a first width sized to fit through the blood vessel lumen. The second shape has a second width greater than the first width and sized to engage with the blood vessel lumen and secure the distal end within the blood vessel lumen.

[0004] On the other hand, a method of cannulating a blood vessel in tissue includes inserting a needle through the vessel wall to form a channel for entry into the vessel. The needle extends through a distal tip at the end of the cannula. The method further includes inserting the tip and the cannula through the channel into a lumen defined by the blood vessel, and switching the tip from a first shape to a second shape. The first shape has a first width sized to fit through the blood vessel lumen. The second shape has a second width greater than the first width and sized to engage with the blood vessel lumen and secure the tip in place within the blood vessel lumen.

[0005] On the other hand, a distal end of a cannulation system for cannulating a blood vessel is provided. The distal end defines a distal end lumen connected to a cannulation lumen. The distal end may vary between a first shape and a second shape. The first shape has a first width, the first width being sized to fit through the blood vessel lumen. The second shape has a second width, the second width being greater than the first width and sized to engage with the blood vessel lumen and secure the distal end in place within the blood vessel lumen. Attached Figure Description

[0006] To gain a more complete understanding of the nature and intended purpose of the invention, the following detailed description will be made in conjunction with the accompanying drawings, wherein similar reference numerals throughout the various figures denote corresponding parts.

[0007] Figure 1 A schematic diagram of the external support system is depicted.

[0008] Figure 2 A schematic diagram of a portion of an external support system is shown.

[0009] Figure 3 An isometric view depicting a portion of the external support system.

[0010] Figure 4 An intubation system employing a variable tip is depicted according to an embodiment of the present disclosure, wherein the variable tip is in a first shape.

[0011] Figure 5 Depicting Figure 4 An isometric view of a portion of the cannulation system, in which the variable tip is in a second shape.

[0012] Figure 6 Depicting Figure 4 An enlarged isometric view of the variable tip of the cannulation system, showing surface features on the variable tip. Detailed Implementation

[0013] The invention can be most clearly understood by referring to the following definitions.

[0014] As used herein, the singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise.

[0015] Unless specifically stated or obvious from the context, as used herein, the term “about” should be understood as being within the normal tolerance range in the field, such as within 2 standard deviations of the mean. “About” can be understood as being within 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1%, 0.05%, or 0.01% of the specified value. Unless the context otherwise leads to conclusion, all numerical values ​​provided herein are modified by the term “about”.

[0016] As used in the specification and claims, the terms “comprises,” “comprising,” “including,” “having,” etc., may have the meanings given to them by U.S. patent law and may mean “includes,” “including,” etc.

[0017] Unless specifically stated or obvious from the context, the term “or” as used herein should be understood as inclusive.

[0018] The ranges provided herein should be understood as a simplified representation of all values ​​within that range. For example, the range 1 to 50 should be understood as including any number, combination of numbers, or subrange of any group consisting of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 (and their fractions, unless the context clearly specifies otherwise).

[0019] This document describes an improved cannulation system. For example, the cannulation system includes a distal end with a variable shape. The cannulation system eliminates the need for a dilator and is simpler than existing systems. Furthermore, the cannulation system described herein eliminates the need for slit ports or clamps on the sides of the cannula. Moreover, the cannulation system simplifies or eliminates the tools and methods required for coordinating and positioning the cannula. Additionally, the cannula can have a reduced diameter and is therefore easier to position in smaller vessels compared to existing cannulas. Furthermore, the described embodiments reduce the number of steps in the method of cannulation and simplify the cannulation procedure.

[0020] External support system

[0021] Now for reference Figures 1 to 6One aspect of this disclosure provides an intubation system for use in external support systems that are particularly useful for newborns.

[0022] refer to Figures 1 to 3 System 10 is configured to provide external support to the newborn. According to one aspect of this disclosure, system 10 can be configured to provide a system environment similar to the environment experienced by the newborn in the womb. By placing the newborn in the environment of system 10, the developmental capacity of newborns leaving the womb (e.g., due to preterm birth) and, for example, those between approximately 23 and approximately 24 weeks of gestation can be enhanced.

[0023] According to one aspect of this disclosure, the system environment can be configured to achieve any of the following: (1) limiting the newborn's exposure to light; (2) limiting the newborn's exposure to sound; (3) keeping the newborn immersed in a liquid environment; (4) keeping the newborn within a desired temperature range; (5) minimizing exposure to environmental contamination; or (5) any combination of the foregoing. The system also allows newborn activities necessary for organ growth and development (e.g., newborn respiratory movements, newborn swallowing liquids).

[0024] System 10 can be configured to treat newborns (e.g., those with an estimated gestational age of less than 37 weeks, particularly those with an estimated gestational age of 28 to 32 weeks) or extremely preterm newborns (those with an estimated gestational age of 23 to 28 weeks). This gestational period is provided for humans, but corresponding preterm newborns in other animals can also be used. In certain embodiments, the newborn does not have underlying congenital diseases. Full-term or preterm newborns may have limited lung gas exchange capacity, for example due to lung dysplasia or congenital abnormalities affecting lung development, such as congenital diaphragmatic hernia. In certain aspects, the subject may be a preterm or full-term newborn awaiting lung transplantation, for example due to congenital lung diseases (e.g., bronchoalveolar dysplasia, surfactant protein B deficiency, etc.). Currently, such transplantation procedures are rarely performed in the United States. However, utilizing the more stable lung support methods provided by embodiments of this disclosure could increase the number of transplantation procedures. The newborn 5 may also be a participant in extrauterine treatment during labor (EXIT) delivery, including patients with severe airway disease and those expected to have a long course of illness before final resection. Neonate 5 may also be a patient for neonatal surgery or fetoscopy, especially in cases where preterm labor necessitates early delivery. According to one aspect of this disclosure, system 10 can be configured to keep neonate 5 in system 10 for the required period of time (e.g., days, weeks, or months, until neonate 5 is able to survive without system 10). System 10 should be able to keep neonate 5 in place for at least 7 days, at least 14 days, at least 21 days, at least 28 days, at least 35 days, at least 42 days, at least 49 days, or at least 56 days.

[0025] System 10 includes a neonatal chamber 100 configured to accommodate a newborn 5, a saline solution circuit configured to provide a flow (e.g., a constant flow) of saline solution (PSS) through the neonatal chamber 100, and an oxygenation circuit 400 (e.g., an extracorporeal membrane oxygenation system) configured to remove carbon dioxide from the newborn's blood and supply oxygen to the newborn's blood.

[0026] System 10 is configured to keep the newborn 5 in the neonatal ward 100 immersed in the PSS (Post-Oxygenation System). System 10 is also configured such that the oxygenation circuit 400 provides sufficient gas exchange for the newborn 5 to sustain life. In this way, system 10 provides an environment similar to the intrauterine environment to promote the continued growth and development of the newborn 5. System 10 may include a trolley or similar device to facilitate the monitoring, care, and transport of the newborn 5 within a medical facility.

[0027] According to one aspect of this disclosure, system 10 may be identical to that described in U.S. Patent No. 11,471,351 entitled “System and Method Configured to Provide Extracorporeal Support for Premature Fetus”.

[0028] The oxygenation circuit 400 can be connected to the newborn 5 in a venous / venous arrangement (e.g., using the mechanical pump included in system 10). Alternatively, the oxygenation circuit 400 can be connected to the newborn 5 in an arterial / venous arrangement. The cannula can be placed in a large carotid vessel (e.g., carotid artery, jugular vein) of the newborn 5 to connect the newborn 5's circulatory system to the oxygenator 500. Placement in a large carotid vessel avoids problems of spasm in the umbilical vessels and cannula instability. The outer portion of the cannula can mate with a sleeve (e.g., to allow for increased tension on the sutures). The sleeve can be made of silicone and can be, for example, about 1-10 cm long, particularly about 3-5 cm long. The cannula can be sutured to the newborn 5 (e.g., via the mating sleeve) to secure the cannula to the neck of the newborn 5.

[0029] In some embodiments, the oxygenation circuit 400 may be connected to the newborn 5 via the umbilical cord. In such an arrangement, the cannula may be sutured into the veins and arteries of the umbilical cord. It should be understood that other connection arrangements may also be used. U.S. Provisional Application No. 63 / 017,204 describes a non-sutureless device.

[0030] The oxygenation circuit 400 may include an oxygenator 500 for providing gas exchange functionality to the newborn 5, specifically exchanging oxygen to and from the newborn and exchanging carbon dioxide. The oxygenator 500 may be removably connected to the newborn 5 and optionally connected to the oxygenation circuit 400 and other components of the system 10. The oxygenator 500 is connected to the newborn 5 via two or more fluid lines and includes at least an outlet line 440 and an inlet line 445. Blood flows from the newborn 5 through the outlet line 440 to the oxygenator 500. The blood then flows through the oxygenator 500 and returns to the newborn 5 via the inlet line 445.

[0031] In some embodiments, the oxygenator 500 may be configured to be disconnected and replaced during operation of the oxygenation circuit 400. If the oxygenator 500 is damaged or has exceeded its expected lifespan (typically 8 hours, subject to regulatory approval), the oxygenation circuit 400 may be temporarily configured to bypass the oxygenator 500 so that the oxygenator 500 can be disconnected from the oxygenation circuit 400 and a new, ready-to-use oxygenator 500 can be connected in its place without interrupting blood flow.

[0032] Heating and / or cooling element 600 may be connected to system 10 and arranged to regulate the temperature of one or more components of system 10.

[0033] Intubation system

[0034] Figure 4 An intubation system 200 according to an embodiment of the present disclosure is depicted. The intubation system can be integrated into a reference. Figure 1-3 The oxygenation circuit 400. In some cases, the cannula can be integrated into the cannula insertion system described with reference to U.S. Patent Publication No. 2021 / 0338270A1.

[0035] refer to Figure 4-6 A cannulation system (generally indicated by 200) is used for cannulating a blood vessel. Cannulation system 200 includes a cannula 202 having a distal end 204 and a proximal end 206. Cannula 202 defines a cannula lumen 208 extending from the proximal end 206 to the distal end 204. In this example, cannula 202 includes a rigid segment 205 extending proximally from the distal end 204 and a flexible segment 207 extending from the rigid segment to the proximal end 206.

[0036] The intubation system 200 includes a tip 210 located at the distal end 204 of the cannula 202. The tip 210 defines a tip lumen 212 connected to the cannula lumen 208. The tip 210 may be in a first shape (in Figure 4 (shown in) and the second shape (in) Figure 5 and 6The first shape has a first width, the dimensions of which are set to fit through the lumen of a blood vessel. The second shape has a second width greater than the first width, and the dimensions of the second width are set to engage with the lumen of the blood vessel and fix the tip 210 in place within the lumen of the blood vessel.

[0037] The cannulation system 200 includes a needle 214 sized to fit through a cannulation lumen 208 and a distal lumen 212. A distal end 210 defines a distal opening 216 arranged to allow the needle 214 to extend through and engage with a blood vessel.

[0038] In this example, the cannula 202 includes a diaphragm seal 218 located proximal to the tip 210, and the diaphragm seal 218 is arranged to allow the needle 214 to enter or exit the cannula lumen 208. The diaphragm seal 218 is located on the flexible section 207 of the cannula. The diaphragm seal 218 facilitates the insertion of the needle 214 and allows for easy removal of the needle without a slit port.

[0039] Suitable, the cannula is made of biocompatible materials such as stainless steel, cobalt-chromium alloy, titanium, nickel-titanium alloy, tantalum, tungsten-nickel plated, tungsten-brass plated, polycarbonate, PEEK, PES, fiber-reinforced plastics, or combinations thereof.

[0040] End of intubation

[0041] Figure 4-6 An example of a tip 210 is shown. The tip 210 can vary between a first shape and a second shape. In embodiments, the second shape can have different dimensions and / or geometry than the first shape. For example, the tip 210 is a perforated flexible sleeve or support. The first shape of the tip 210 is a gradually tapering truncated cone shape. The second shape of the tip 210 is a cylindrical shape with a defined diameter. This diameter defines the width of the second shape and is greater than the width of the first shape. For example, the width of the first shape can be about 1 mm or less, while the second width of the second shape can be in the range of 3 mm to 6 mm. The length of the tip 210 can be in the range of 6 mm to 11 mm. In other embodiments, the tip 210 can have other shapes. For example, in some embodiments, the tip 210 can be a cuboid, a sphere, a rectangular cuboid, and / or any suitable shape.

[0042] like Figure 4As shown, in the first shape, the tip 210 tapers gradually from a larger diameter at the proximal end 204 to a smaller diameter that matches the outer diameter of the needle at the distal end. This smaller diameter defines the minimum width of the first shape. The tip 210 defines a distal opening 216, which is arranged to allow the needle to extend through and engage with a blood vessel at the distal end. The tapering shape provides a smooth transition between the outer diameter of the needle 214 and the outer diameter of the cannula 202.

[0043] In this example, the distal end 210 includes a feature 220 disposed on its outer surface and arranged to engage with the inner surface of the blood vessel. This feature may include ribs or projections and facilitate engagement and fixation of the distal end 210 to the blood vessel. For example, the feature may be arranged on the outer surface of the distal end 210 in an irregular pattern (e.g., asymmetrical relative to the transverse axis of the cannula) such that the feature facilitates engagement with the blood vessel without hindering the introduction of the distal end 210 into the blood vessel. In other embodiments, this feature is omitted.

[0044] In this example, the tip 210 is made of a shape memory alloy such as a nickel-titanium (NiTi) alloy. The shape memory alloy can facilitate the tip 210 to switch shapes. In other examples, the tip is made of biocompatible materials such as stainless steel, cobalt-chromium alloy, titanium, nickel-titanium alloy, tantalum, tungsten-plated nickel, tungsten-plated brass, polycarbonate, PEEK, PES, fiber-reinforced plastics, or combinations thereof.

[0045] A retainer may be provided to secure the tip to either a first or second shape. For example, the retainer may be a separate component that engages with the tip 210 of the first or second shape. Alternatively, the retainer may be incorporated into the tip 210 and / or the cannula 202. The retainer may be removed or adjusted to switch the tip between the first and second shapes. In some embodiments, the retainer is a biasing member, a pin, a snap-fit, and / or any other suitable retainer.

[0046] When the tip 210 is in the neutral position, the tip 210 may have a first shape or a second shape, and a force is required to hold or maintain the other shape between the first and second shapes. Suitably, a retainer can hold the tip 210 in the first and / or second shape. In some embodiments, the retainer is omitted.

[0047] In one embodiment, the tip 210 has a second shape in a neutral state, and the retainer is merged with the needle 214. A feature on the needle 214 engages with the tip 210 and holds the tip 210 in a first shape, which is a folded state of the tip 210. When the needle is removed, the constraint on the tip 210 is removed, and the tip 210 expands into the second shape.

[0048] In one embodiment, the distal end 210 has a second shape in a neutral state, and the retainer is a sheath. For example, the sheath is placed on the distal end 210 to secure it in a first folded shape. The sheath can be removed from the distal end 210 when the cannula 202 and the distal end are in place within the blood vessel. When the sheath is removed, the distal end 210 expands into a second expanded shape.

[0049] In one embodiment, the tip has a second shape in a neutral state, and the retainer is a constraint filament engaged with the tip 210. When the filament is removed, the constraint on the tip 210 is removed and the tip 210 expands into the second shape.

[0050] In one embodiment, a retainer is not required. The distal end 210 is in a first shape in a neutral state. When the distal end 210 is in place within the blood vessel, a sac expands within the distal end 210, and the sac causes the distal end 210 to expand to a second shape through plastic deformation, after which the sac is removed.

[0051] In one embodiment, a retainer is incorporated into the tip 210 and the cannula, such that the tip 210 is held in a first shape by its position relative to the cannula. For example, twisting the distal end of the tip 210 relative to the cannula causes the distal end of the tip 210 to be positioned in the first shape. After the tip 210 is positioned within the blood vessel, the distal end of the tip is twisted in the opposite direction relative to the cannula to change the tip to a second shape.

[0052] In some embodiments, at least a portion of the cannula 202 (e.g., a flexible segment) and the tip 210 are integral components. The tip 210 and the cannula 202 may be made of the same material, such as a nitinol shape memory alloy, to facilitate the manipulation of the cannula and the tip. In other embodiments, the flexible segment of the cannula proximal to the tip 210 is a deformable support structure and facilitates the dimensional expansion of the tip 210 and / or introduced elements (such as a balloon). The system may include a deformable fluid-tight cap around or inside the deformable cannula 202 to achieve a fluid-tight structure.

[0053] In one embodiment, an external clamping mechanism is incorporated into the cannula 202 and clamps onto the vascular tissue surrounding the cannula to facilitate securing the cannula, along with the distal end 210, into place.

[0054] Intubation system and methods of using the intubation system

[0055] The cannula tip can be used in cannulation systems, such as Figure 4 The cannulation system described herein. For example, the cannulation system may be configured to penetrate a target blood vessel, enlarge an opening in the vessel wall, connect a cannula to the blood vessel (e.g., by inserting a portion of the cannula through the resulting opening into the blood vessel), and secure the cannula to the blood vessel via the distal end described herein.

[0056] The cannulation system may include a needle assembly and a cannula. The needle assembly may include a needle. For example, the needle is configured to extend through an opening in a distal tip of the cannula and puncture a blood vessel, thereby creating a channel for access to the blood vessel. The distal tip and the cannula can be inserted through the channel into a lumen defined by the blood vessel.

[0057] Suitablely, the cannulation system does not require a dilator assembly. For example, the needle is housed in a distal end rather than within a dilator assembly. Furthermore, the distal end is arranged to facilitate needle manipulation and cannulation into the vessel lumen. Additionally, after the tip of the needle pierces the vessel wall, the distal end dilates to secure the cannula in place and create a larger opening in the vessel. For example, the distal end switches between a first shape and a second shape, the first shape having a first width sized to fit through the vessel lumen, and the second shape having a second width greater than the first width and sized to engage with the vessel lumen and secure the distal end within the vessel lumen.

[0058] The cannula is configured to have a fluid connection at one end to the blood vessel to be cannulated and a fluid connection at the other end to the circulatory system. The cannula and the distal end may define a lumen extending along the length of the cannula and the distal end.

[0059] In one embodiment, the cannulation system provides a clinician with a method for securely attaching a cannula to a cannulation region (such as, but not limited to, a blood vessel). In one example, a needle passes through a diaphragm seal, through the interior of the cannula lumen, and exits from a distal tip on the cannula. The tip has a first shape in which it tapers gradually from a larger diameter at the distal end to a smaller diameter that matches the outer diameter of the needle. The tapering shape provides a smooth transition between the outer diameter of the needle and the outer diameter of the cannula. During cannulation, the needle is used to penetrate the vessel wall. The cannula is advanced such that the distal end of the tip passes through an opening and enters the interior of the vessel. When the tip is within the vessel, the needle retracts into the lumen defined by the tip. The cannula assembly is advanced until the entire tip and at least a portion of the rigid section of the cannula are within the vessel lumen.

[0060] Therefore, a cannula is inserted into the lumen defined by the blood vessel. When the cannula is in place, the method includes switching the distal tip of the cannula from a first shape to a second shape. The second shape has a second width greater than the first width of the first shape, and is sized to engage with the blood vessel lumen and secure the tip within the lumen. The expanded second shape presses into the inner surface of the blood vessel and provides an open path from the blood vessel lumen to the cannula lumen.

[0061] When the distal end is in the second dilated shape, the needle can be removed from the blood vessel and distal end through the lumen of the cannula. The cannulation system may include a diaphragm seal for inserting and removing the needle from the cannula.

[0062] Although preferred embodiments of the invention have been described using specific terminology, such description is for illustrative purposes only, and it should be understood that changes and modifications may be made without departing from the spirit or scope of the following claims.

[0063] By incorporating references

[0064] All patents, published patent applications and other references cited in this article are explicitly incorporated herein in their entirety through citation.

Claims

1. A cannulation system for cannulating a blood vessel, the cannulation system comprising: A cannula having a distal end and a proximal end, the cannula defining a lumen; as well as A distal end, located at the distal end of the cannula, defines a distal lumen connected to the lumen of the cannula, wherein the distal end is versatile between a first shape and a second shape, the first shape having a first width sized to fit through the lumen of the blood vessel, and the second shape having a second width greater than the first width and sized to engage with the lumen of the blood vessel and secure the distal end within the lumen of the blood vessel.

2. The cannulation system according to claim 1, wherein, The cannula includes a rigid section extending from the distal end and a flexible section extending from the rigid section to the proximal end.

3. The cannulation system of claim 1 further includes a needle, the needle being sized to move through the cannulation lumen and the distal lumen, and wherein, The distal end defines a distal opening, which is arranged to allow the needle to extend outward from the distal lumen and engage with the blood vessel.

4. The cannulation system according to claim 3, wherein, The cannula includes a diaphragm seal located proximal to the tip and arranged to allow the needle to enter the cannula lumen.

5. The cannulation system according to claim 1, wherein, The tip is a perforated flexible sleeve, wherein the first shape of the tip is a truncated cone shape, and the second shape of the tip is a cylindrical shape.

6. The cannulation system according to claim 1, wherein, The terminal includes a feature portion disposed on the outer surface of the terminal and arranged to engage with the inner surface of the blood vessel.

7. The cannulation system according to claim 6, wherein, The feature portion is arranged in an irregular pattern on the outer surface of the tip.

8. The cannulation system according to claim 1, wherein, At least one of the cannula and the tip is made of a nickel-titanium shape memory alloy.

9. The cannulation system of claim 1, further comprising a retainer for securing the distal end to the first shape or the second shape, wherein, The retainer is removed or adjusted to allow the tip to switch between the first shape and the second shape.

10. The cannulation system according to claim 1, wherein, The cannula is made of stainless steel, cobalt-chromium alloy, titanium, nickel-titanium alloy, tantalum, tungsten-plated nickel, tungsten-plated brass, polycarbonate, PEEK, PES, fiber-reinforced plastic, or a combination thereof.

11. The cannulation system according to claim 1, wherein, The cannulation system is configured to be operatively connected to an extracorporeal membrane oxygenation (ECMO) system.

12. The cannulation system according to claim 1, wherein, The blood vessels in question are the vascular system of the newborn's umbilical cord.

13. A method for cannulating a blood vessel in a tissue, the method comprising: A needle is inserted through the blood vessel to form a channel in the blood vessel, wherein the needle extends through a tip located at the distal end of the cannula; The distal end and the cannula are inserted through the channel into the lumen defined by the blood vessel; as well as The tip is switched from a first shape to a second shape. The first shape has a first width, the size of which is set to fit through the lumen of the blood vessel. The second shape has a second width, the second width being greater than the first width and its size being set to engage with the lumen of the blood vessel and fix the tip in place within the lumen of the blood vessel.

14. The method of claim 13, further comprising inserting the needle through a diaphragm seal of the cannula and inserting it into the cannula lumen.

15. The method of claim 13, further comprising removing the needle from the cannula lumen when the tip is in the second shape.

16. A distal end of a cannulation system for cannulating a blood vessel, the distal end defining a distal end lumen connected to a cannulation lumen, wherein the distal end is configurable between a first shape and a second shape, the first shape having a first width sized to fit through the lumen of the blood vessel, and the second shape having a second width greater than the first width and sized to engage with the lumen of the blood vessel and secure the distal end within the lumen of the blood vessel.

17. The distal end according to claim 16, wherein, The distal end defines a distal opening, which is arranged to allow the needle to extend through and engage with the blood vessel.

18. The distal end according to claim 16, wherein, The tip is made of stainless steel, cobalt-chromium alloy, titanium, nickel-titanium alloy, tantalum, tungsten-plated nickel, tungsten-plated brass, polycarbonate, PEEK, PES, fiber-reinforced plastic, or a combination thereof.

19. The distal end according to claim 16, wherein, The end is a perforated flexible sleeve.

20. The distal end according to claim 16, wherein, The first shape of the tip is a truncated cone shape, and the second shape of the tip is a cylindrical shape.

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