Methods of intravascular fluid supply for preterm infants and devices therefor

Abstract

The present invention relates generally to the technological field of neonatal intensive care. More specifically, the present invention relates to aspects of umbilical venous or arterial catheterization. The claimed invention represents methods of intravascular fluid supply for preterm infants and devices for performing such methods, which require less infant handling and, furthermore, less time for performing manipulations with an infant staying in an open incubator, thereby providing an improvement of the technological field of neonatal intensive care.

Description

METHODS OF INTRAVASCULAR FLUID SUPPLY FOR PRETERMINFANTS AND DEVICES THEREFORCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority from U.S. Provisional Patent Application No. 63 / 523,177, filed on June 26, 2023, entitled “METHODS OF INTRAVASCULAR FLUID SUPPLY FOR PRETERM INFANTS AND DEVICES THEREFOR”, the contents of which are incorporated by reference herein in their entirety.FIELD OF THE INVENTION

[0002] The present invention relates generally to the technological field of neonatal intensive care. More specifically, the present invention relates to aspects of umbilical venous or arterial catheterization.BACKGROUND OF THE INVENTION

[0003] Intravascular fluid supply (e.g., medication or blood supply) for preterm infants is known to be a critical part of neonatal treatment of very and extreme preterm infants. Since blood vessels of umbilical cord are directly connected to infant’s cardiovascular system, umbilical venous or arterial catheterization is considered a reliable alternative to percutaneous peripheral or central venous catheterization or intraosseous cannulation.

[0004] Conventional method of umbilical venous or arterial catheterization include placing purse string suture or umbilical tape at the junction of the skin and the cord to provide hemostasis; cutting off the umbilical cord in proximity to the abdominal wall (leaving a 1-2 cm stump); identifying and slightly dilating the desired vessel; inserting the catheter through the vessel and positioning it properly (the correctness of catheter position is confirmed radiographically); securing the catheter to the umbilical stump using the purse string or umbilical tape and then securing it to the infant body.

[0005] The described method suffers from many disadvantages. It requires opening the incubator, which may cause hypothermia and lead to intracranial hemorrhage. In addition, sanitizing the abdominal wall may cause chemical bums. Other possible complications may include infections (such as Neonatal sepsis), thrombosis, air embolism, vessel perforation etc. Furthermore, the method is extremely hard to perform accurately, since the umbilicalstump and the blood vessels are very small. Hence, it often requires excessive baby handling, which may interfere with baby wellbeing, since the procedure needs to be done mainly in the first hours after birth, when the baby is extremely sensitive.SUMMARY OF THE INVENTION

[0006] Accordingly, there is a need for methods of intravascular fluid supply for preterm infants and devices for performing such methods, which would correct indicated deficiencies of the prior art. In particular, there is a need for methods and devices therefor, which would require less infant handling and, furthermore, less time for performing manipulations with an infant staying in an open incubator, thereby providing an improvement of the technological field of neonatal intensive care.

[0007] In the general aspect, the claimed invention may be directed to an umbilical catheter. The catheter may include a first tube having at least one first fluid supply lumen, at least one inflatable envelope, enveloping the first tube and sized to be movable along the first tube in a deflated state and to be secured thereto in an inflated state, and at least one second tube having a second fluid supply lumen in fluid connection to the at least one inflatable envelope.

[0008] In another general aspect, the claimed invention may be directed to an umbilical cord clamping device. The clamping device may include two elongated parts, said two elongated parts being pivotably connected at a first end and including lock means at a second end. Each of the elongated parts at an inner side may include a first groove configured to form, in a closed position, with a corresponding first groove of the other elongated part, an opening, sized to accommodate an umbilical cord so as to apply pressure on the umbilical cord while not occluding an umbilical catheter inserted into blood vessel of the umbilical cord. At least one of the elongated parts may include at an outer side at least one second groove sized to accommodate and secure a loose end of the umbilical catheter.

[0009] In yet another general aspect, the claimed invention may be directed to an umbilical cord slitting device. The slitting device may include a first elongated part and a second elongated part, said first and second elongated parts being pivotably connected at a first end and including lock means at a second end. At least one of the first and second elongated parts may include one or more sharpened edges, wherein said edges may be angled in relation to a transverse direction of a respective elongated part and project outwardly therefrom, thereby forming a cutting point. Each of said first and second elongated parts at an inner side may include at least one groove extending in the transverse direction of arespective elongated part, wherein said at least one groove may be configured to form, in a closed position, with a corresponding groove of the other elongated part, an opening, sized to accommodate an umbilical catheter so as to provide unobstructed movement of the device along the umbilical catheter.

[0010] In yet another general aspect, the claimed invention may be directed to a method of intravascular fluid supply for preterm infants. Said method may include cutting off an umbilical cord at a first distance from an abdominal wall of an infant (e.g., at least 5 cm away from the abdominal wall), inserting one or more umbilical catheters through one or more blood vessels of an umbilical stump, accommodating loose ends of the one or more umbilical catheters in a slitting device, wherein the slitting device may be configured to slide along the one or more umbilical catheters while maintaining the integrity thereof, moving the slitting device along the one or more umbilical catheters towards the abdominal wall up to a second distance from the abdominal wall, thereby slitting the umbilical stump into strips, cutting off the strips at the second distance from the abdominal wall, and supplying a fluid via the one or more umbilical catheters.

[0011] In yet another general aspect, the claimed invention may be directed to another method of intravascular fluid supply for preterm infants. Said method may include cutting off an umbilical cord at a first distance (e.g., at least 5 cm) from an abdominal wall of an infant, inserting one or more umbilical catheters through one or more blood vessels of an umbilical stump, wherein each of the one or more umbilical catheters include at least one protected portion at least partially covered with a hard covering, and wherein each of the one or more umbilical catheters may be inserted so as to have the at least one protected portion positioned at a second distance from the abdominal wall, cutting off the umbilical cord at the second distance from the abdominal wall around the at least one protected portion, and supplying a fluid via the one or more umbilical catheters.

[0012] In some embodiments, the umbilical catheter may be sized to be inserted into a blood vessel of an umbilical cord in the deflated state and to occlude the blood vessel in the inflated state, while maintaining the integrity of the blood vessel.

[0013] In some embodiments, the umbilical catheter may further include distance markings on the first tube, indicating distance from the proximal end thereof.

[0014] In some embodiments, the umbilical catheter may further include at least one dent portion along the first tube, sized to accommodate the at least one inflatable envelope in the inflated state.

[0015] In some embodiments, the umbilical catheter may further include at least one protected portion at least partially covered with a hard covering.

[0016] In some embodiments of the umbilical catheter, the hard covering may be made of or may contain a metal.

[0017] In some embodiments, the umbilical catheter may further include a plurality of inflatable envelopes arranged successively along the first tube, and a plurality of second tubes, each having the second fluid supply lumen in fluid connection to a respective inflatable envelope (to be inflated with air or fluid) of the plurality of inflatable envelopes.

[0018] In some embodiments of the umbilical catheter, the first tube and the at least one inflatable envelope may be made of materials having different transparency (in order to be detected by transillumination of the umbilical cord).

[0019] In some embodiments of the umbilical catheter, the first tube and the at least one inflatable envelope may be made of materials having different coloring.

[0020] In some embodiments of the umbilical catheter, the length of the first tube may be 15-40 cm, and the diameter may be 3.5-10 Fr.

[0021] In some embodiments of the umbilical catheter, the diameter of the at least one inflatable envelope in the deflated state may be 4-11 Fr and in the inflated state may be 5- 10 mm.

[0022] In some embodiments of the umbilical cord clamping device, the first groove may be at least partially coarse textured.

[0023] In some embodiments, the umbilical cord clamping device may include a pair of second grooves on the outer side of at least one of the elongated parts.

[0024] In some embodiments of the umbilical cord clamping device, the at least one second groove may include at least one inwardly projected lip, configured to prevent dislodgement of the loose end of the umbilical catheter when accommodated in the at least one second groove.

[0025] In some embodiments of the umbilical cord clamping device, the length of each elongated part may be 1-5 cm.

[0026] In some embodiments of the umbilical cord slitting device, at least one of the first and second elongated parts may further include an additional slitting wing projecting perpendicularly from the outer side of a respective elongated part, wherein said additional slitting wing may include a sharpened edge angled in relation to a transverse direction of the respective elongated part and projecting outwardly therefrom, thereby forming, together with the other sharpened edges, in the closed position, the cutting point.

[0027] In some embodiments of the umbilical cord slitting device, at least one of the first and second elongated parts may include a handle.

[0028] In some embodiments of the umbilical cord slitting device, the length of each of said one or more sharpen edges may be 1-3 cm.

[0029] In some embodiments of the umbilical cord slitting device, the length of said additional slitting wing may be 1-3 cm.

[0030] In some embodiments of the umbilical cord slitting device, the length of said handle may be 3-15 cm.

[0031] In some embodiments of the umbilical cord slitting device, the diameter of said opening may be 1-3 mm.

[0032] In some embodiments of the claimed methods, the one or more blood vessels may include an umbilical artery and wherein the one or more umbilical catheters may include an umbilical arterial catheter (UAC).

[0033] In some embodiments of the claimed methods, the one or more blood vessels may include an umbilical vein and wherein the one or more umbilical catheters may include an umbilical venous catheter (UVC).

[0034] In some embodiments of the first of the claimed methods, the slitting device may include at least one sharpened front edge and may be positioned so as to face an umbilical stump.

[0035] In some embodiments of the first of the claimed methods, the method may further include clamping umbilical stump with an umbilical cord clamping device at a third distance from the abdominal wall, wherein the third distance is shorter than the second distance.

[0036] In some embodiments of the first of the claimed methods, the umbilical cord clamping device may be configured to clamp the umbilical cord so as to apply pressure on the umbilical cord while not occluding the one or more umbilical catheters.

[0037] In some embodiments of the first of the claimed methods, the umbilical cord clamping device may further include at least one groove, sized to secure loose ends of the one or more umbilical catheters; and the method may further include securing loose ends of the one or more umbilical catheters to the umbilical cord clamping device.

[0038] In some embodiments of the second of the claimed methods, the one or more umbilical catheters may include: at least one inflatable envelope; at least one first tube passing through the at least one inflatable envelope and having at least one first fluid supply lumen; and at least one second tube having a second fluid supply lumen in fluid connection to the at least one inflatable envelope; and wherein supplying the fluid via the one or more umbilical catheters may include supplying the fluid via a respective at least one first tube; wherein inserting the one or more umbilical catheters through the one or more blood vessels may be performed in a deflated state; and wherein the method may further include inflating the at least one inflatable envelope of the one or more umbilical catheters to occlude a respective blood vessel, thereby securing the umbilical catheter therein.

[0039] In some embodiments of the second of the claimed methods, the at least one first tube and the at least one inflatable envelope may be made of materials having different transparency or coloring; and wherein inserting the one or more umbilical catheters may further include transilluminating the umbilical stump to determine a position of the at least one inflatable envelope within the respective blood vessel, and positioning the at least one protected portion at the second distance from the abdominal wall, based on the determined position.

[0040] In some embodiments of the second of the claimed methods, the method may further include clamping the umbilical stump with an umbilical cord clamping device at a third distance from the abdominal wall, wherein the third distance is shorter than the second distance.

[0041] In some embodiments of the second of the claimed methods, said third distance is between the inflatable envelope of the one or more umbilical catheters and the abdominal wall.

[0042] In some embodiments of the second of the claimed methods, the umbilical cord clamping device is configured to clamp the umbilical cord so as to apply pressure on the umbilical cord while not occluding the one or more umbilical catheters.

[0043] In some embodiments of the second of the claimed methods, the umbilical cord clamping device may include at least one groove, sized to secure loose ends of the one or more umbilical catheters; and the method may further include securing loose ends of the one or more umbilical catheters to the umbilical cord clamping device.

[0044] In some embodiments of the second of the claimed methods, the method may further include clamping the umbilical stump with the umbilical cord clamping device at a fourth distance from the abdominal wall, wherein the fourth distance is between the second distance and the inflatable envelope of the respective one or more umbilical catheters.

[0045] In some embodiments of the second of the claimed methods, the one or more umbilical catheters may include: a first tube having at least one first fluid supply lumen, an inflatable envelope, enveloping the at least one first tube and sized to be movable along the at least one first tube in a deflated state and to be secured thereto in an inflated state, and a second tube having a second fluid supply lumen in fluid connection to the inflatable envelope; wherein supplying the fluid via the one or more umbilical catheters may include supplying the fluid via the first tube; wherein inserting the one or more umbilical catheters through the one or more blood vessels is performed in a deflated state. In such embodiments, the second method may further include, prior to inserting the one or more umbilical catheters through the one or more blood vessels, setting the inflatable envelope at the desired distance from the proximal end of the first tube; inflating the inflatable envelope of the one or more umbilical catheters to occlude a respective blood vessel, thereby securing the umbilical catheter therein; and clamping the umbilical stump with umbilical cord clamping devices, distal and proximal to the inflatable envelope.BRIEF DESCRIPTION OF THE DRAWINGS

[0046] The subject matter regarded as the invention is particularly pointed out and distinctly claimed in the concluding portion of the specification. The invention, however, both as to organization and method of operation, together with objects, features, and advantages thereof, may best be understood by reference to the following detailed description when read with the accompanying drawings in which:

[0047] Fig. 1A is a side view of an umbilical catheter, according to some embodiments;

[0048] Fig. IB is a side view of an umbilical catheter in the form of a cannula, according to some embodiments;

[0049] Fig. 2A is an isometric view of a catheter securing umbilical cord clamping device in a closed position, clamped on the umbilical cord and having loose ends of umbilical catheter secured thereto, according to some embodiments;

[0050] Fig. 2B in an isometric view of the catheter securing umbilical cord clamping device in a closed position, according to some embodiments;

[0051] Fig. 2C in an isometric view of the catheter securing umbilical cord clamping device in an open position, according to some embodiments;

[0052] Fig. 3A is an isometric view of an umbilical cord slitting device in an open position, facing an umbilical stump and having two umbilical catheters accommodated in respective grooves, according to some embodiments;

[0053] Fig. 3B is an isometric view of the umbilical cord slitting device in a closed position, according to some embodiments;

[0054] Fig. 3C is an isometric view of the umbilical cord slitting device in the closed position, having two umbilical catheters accommodate in respective openings and slitting the umbilical stump, according to some embodiments;

[0055] Fig. 3D is an isometric view of an umbilical cord slitting device in a closed position, the slitting device having additional slitting wings, according to some embodiments;

[0056] Fig. 3E is another isometric view of the umbilical cord slitting device in the closed position, the slitting device having additional slitting wings, according to some embodiments;

[0057] Fig. 3F is an isometric view of the umbilical cord slitting device in an open position, the slitting device having additional slitting wings, according to some embodiments;

[0058] Fig. 4A is a flow diagram, depicting a first method of intravascular fluid supply for preterm infants, according to some embodiments;

[0059] Fig. 4B is a flow diagram, depicting a second method of intravascular fluid supply for preterm infants, according to some embodiments; and

[0060] Fig. 5 is an illustration of a system in use according to some embodiments.

[0061] It will be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements.DETAILED DESCRIPTION OF THE PRESENT INVENTION

[0062] One skilled in the art will realize the invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing embodiments are therefore to be considered in all respects illustrative rather than limiting of the invention described herein. Scope of the invention is thus indicated by the appended claims, rather than by the foregoing description, and all changes that come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

[0063] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be understood by those skilled in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the present invention. Some features or elements described with respect to one embodiment may be combined with features or elements described with respect to other embodiments. For the sake of clarity, discussion of same or similar features or elements may not be repeated.

[0064] Although embodiments of the invention are not limited in this regard, discussions utilizing terms such as, for example, “processing,” “computing,” “calculating,” “determining,” “establishing”, “analyzing”, “checking”, “choosing”, “selecting”, “omitting”, “training” or the like, may refer to operation(s) and / or process(es) of a computer, a computing platform, a computing system, or other electronic computing device, that manipulates and / or transforms data represented as physical (e.g., electronic) quantities within the computer’s registers and / or memories into other data similarly represented as physical quantities within the computer’s registers and / or memories or other information non-transitory storage medium that may store instructions to perform operations and / or processes.

[0065] Although embodiments of the invention are not limited in this regard, the terms “plurality” and “a plurality” as used herein may include, for example, “multiple” or “two or more”. The terms “plurality” or “a plurality” may be used throughout the specification to describe two or more components, devices, elements, units, parameters, or the like. The term “set” when used herein may include one or more items.

[0066] In the context of the present description, the terms “proximal” and “distal” when applied in relation to the methods, devices and components thereof, shall be understood as describing an arrangement and / or positioning with respect to the infant’s body.

[0067] The main disadvantages of the prior art conventional method of intravascular fluid supply for preterm infants, and, in particular, of the process of umbilical venous or arterial catheterization, occur in result of performing manipulations with a short umbilical stump (1- 2 cm). Taking into account the extremely small dimensions of the umbilical cord and the vessels of preterm infants, the process appears to be sophisticated and cumbersome, thus increasing the chance of medical errors. Furthermore, the method known in the art involves a lot of infant handling and requires a critical amount of time for the infant to stay under the poorly controlled environmental conditions (within an open incubator or out of it), which may be harmful for the infant.

[0068] In some embodiments, the claimed invention, in turn, makes it possible to perform the majority of the manipulations (e.g., inserting a catheter) with a long umbilical stump and cut it off at the desired distance closer to the abdominal wall afterwards, without endangering the inserted catheter. Obviously, operating with a long umbilical stump is much more convenient than with a short 1-2 cm one, since it gives more freedom (the umbilical stump may be rotated almost in any direction and positioned so as to make it convenient for the physician to perform required manipulations). Furthermore, all major manipulations may be performed distant from the infant, without excessively disturbing him / her.

[0069] Reference is now made to Fig. 1A, which is a side view of an umbilical catheter 100, according to some embodiments.

[0070] In some embodiments, umbilical catheter 100 may include first tube 110 having first fluid supply lumen 110’. Umbilical catheter 100 may further include inflatable envelope 120, enveloping first tube 110 and sized to be movable along first tube 110 in a deflated state and to be secured inside the umbilical stump in an inflated state. Umbilical catheter 100 may further include second tube 130 having second fluid supply lumen 130’ in fluid connection to inflatable envelope 120.

[0071] In the context of the present description, the term “fluid” shall be understood in the broadest possible meaning, e.g., covering both liquid and gas state of substances. For example, in some embodiments, second fluid supply lumen 130’ may be an air supply lumen.

[0072] As known in the art, the correct positioning of the umbilical catheter (e.g., catheter 100) is an extremely important aspect of umbilical vessel catheterization. The proximal end (with respect to the infant) of the umbilical catheter should be advanced until reaching the desired location inside the cardiovascular system of an infant. The correctness of the umbilical catheter (e.g., catheter 100) positioning is confirmed by radiographic imaging.

[0073] In case of UAC, from the umbilicus, the catheter may dive inferiorly and join the right or left internal iliac artery before turning superiorly to the common iliac artery and aorta. As known, positioning of the catheter (e.g., catheter 100) tip can be either “high” or “low”. The high range may be judged relative to thoracic vertebra, e.g., between T6 and T10, to avoid major aortic branches. The low range may be determined relative to lumbar vertebra, e.g., between L3 and L5. As known, the lower position may be associated with a higher rate of vascular complications such as thrombosis or vasospasm.

[0074] As for the UVC, anomalous positioning may occur frequently (approximately 50% of first attempts) because the catheter is usually inserted without imaging guidance and confirmed after placement on subsequent plain film. From the umbilical vein at the umbilicus, the catheter curves superiorly and to the right, joining the left portal vein, passing through the infant ductus venosus to the inferior vena cava and right atrium. The appropriate UVC tip position is in the high inferior vena cava to the low right atrium, typically within 1 cm of the diaphragm. If the UVC tip is proximal to ductus venosus it can lead to administration of intravenous fluids into the portal system, with potential portal vein thrombosis, or, in cases of TPN administration, a TPN abscess.

[0075] Since preterm infants may vary in size substantially, it makes it even harder to determine the length of the portion of the catheter that should be inserted in order to reach said location in each particular case.

[0076] Furthermore, once the desired location is reached, the catheter should be properly secured with respect to the umbilical stump, in order to prevent dislodgement.

[0077] The claimed invention addresses the abovementioned issues as follows.

[0078] The claimed umbilical catheter (e.g., catheter 100) may be inserted in the desired vessel in the deflated state, and the first tube (e.g., first tube 110) may be advanced therethrough. Once the proximal end of the first tube (e.g., first tube 110) reaches the desired location, the inflatable envelope (e.g., envelope 120) may be inflated through the second tube (e.g., tube 130). In the inflated state the inflatable envelope (e.g., envelope 120) createspressure on the inner walls of the vessel from the one side, and on the first tube (e.g., first tube 110) from the other side, thereby resisting the relative motion of first tube and the vessel. In some embodiments, the position of the inflatable envelope (e.g., envelope 120) may be additionally secured by clamping the umbilical stump either proximal to or distal to the inflatable envelope.

[0079] Furthermore, since the inflatable envelope (e.g., envelope 120) may stay within the umbilical stump (without advancing further) while the end of the first line (e.g., first line 110) may be positioned at the desired location within the cardiovascular system of the infant, the envelope (e.g., envelope 120) may be configured and sized to be movable along the first tube (e.g., first tube 110) in a deflated state, thereby allowing to change the length of the portion of the first tube (e.g., tube 110) proximal to the envelope (e.g., envelope 120). Therefore, the claimed umbilical catheter (e.g., umbilical catheter 100) may be adjustable according to the size of the infant. In some embodiments, the desired position of the inflatable envelope may be 2-5 cm distal to the abdominal wall.

[0080] Additionally, in some embodiments, umbilical catheter 100 may further include distance markings 111 on first tube 110, indicating distance from the proximal end thereof, thereby providing a tool to control the length of the inserted portion of first tube 110. E.g., the physician may mark the distance from the proximal end of first tube 110 at which inflatable envelope 120 should be positioned once the desired location of the proximal end of first tube 110 within the cardiovascular system of the infant is reached.

[0081] Hence, the claimed invention provides an additional improvement of the technological field of neonatal intensive care by suggesting an umbilical catheter (e.g., catheter 100), that can be self-secured with respect to the blood vessel of the umbilical cord, thereby preventing an undesired dislodgement therewithin, while being adjustable to the size of the infant.

[0082] In some embodiments, to further ensure the secured positioning of inflatable envelope 120 in relation to first tube 110, catheter 100 may further comprise at least one dent portion (not shown in the Figures) along first tube 110, sized to accommodate inflatable envelope 120 in the inflated state.

[0083] In some embodiments, umbilical catheter 100 may further include protected portion 101 at least partially covered with a hard covering. Hard covering may be made of or containing a metal or other material hard enough to protect catheter 100 from being cut whencutting the umbilical cord. Since the hardness of the material may affect the required flexibility of the catheter, it is suggested to protect a comparatively short portion (e.g., portion 101) of the catheter (e.g., 1-2 cm), which, when the catheter is inserted and positioned correctly, will be at the place where the umbilical cord is to be cut off (e.g., slightly distal to inflatable envelope 120). The exact location of protected portion 101 may be easily determined by the physician by palpating the umbilical cord.

[0084] In some alternative embodiments (not shown in figures), the issue of making the umbilical catheter adjustable to the size of the infant is addressed as follows. The umbilical catheter (e.g., catheter 100 as shown in Fig. 1 A) may further include a plurality of inflatable envelopes (e.g., same as envelope 120 shown in Fig. 1A) arranged successively along the first tube (e.g., same as tube 110 shown in Fig. 1A), and a plurality of second tubes (e.g., same as tube 130 shown in Fig. 1A), each having the second fluid supply lumen in fluid connection to a respective inflatable envelope of the plurality of inflatable envelopes. In such alternative embodiments, it may not be necessary to move inflatable envelopes (e.g., same as envelope 120 shown in Fig. 1 A) along the first tube (e.g., same as tube 110 shown in Fig. 1A). After inserting and positioning the catheter correctly, the physician may evaluate and decide which one of the plurality of envelopes should be inflated to fit the size of the particular infant (e.g., the one located 2-5 cm distal to the abdominal wall).

[0085] In some embodiments, in order to alleviate the process of determining the position of inflatable envelope 120 within the umbilical cord, first tube 110 and the inflatable envelope 120 may be made of materials having different transparency or different coloring. In such embodiments, the exact position of inflatable envelope 120 may be determined by transilluminating the umbilical stump. Since, in such embodiments, different elements (e.g., tube 110 and envelope 120) of catheter 100 will look different when transilluminated, they can be easily distinguished by the physician.

[0086] Reference is now made to Fig. IB, depicting a side view of an umbilical catheter in the form of a cannula, according to some embodiments.

[0087] In some embodiments, for short term fluid and medicine delivery after birth - a short (2-5) cm catheter 100”’ arranged as a cannula can be used. Such a catheter (e.g., catheter 100’”) may be placed upon a needle like a standard I.V. cannula. Because no blood flow is needed in the umbilical vein after clamping the cord - catheter 100’” may also have an inflatable envelope (e.g., inflatable envelope 120) for securement. Catheter 100’” can besecured to the umbilical cord with an umbilical cord clamping device (not shown), which is configured to be attached to catheter 100”’.

[0088] In some embodiments, umbilical catheter 100’” may include first tube 110 having first fluid supply lumen 110’. Inflatable envelope 120 (same as shown in Fig. 1A) may be sized to envelop first tube 110. Umbilical catheter 100’” may further include second tube 130 having second fluid supply lumen 130’ in fluid connection to inflatable envelope 120.

[0089] In some embodiments, umbilical catheter 100’” may further include connecting portion 112, configured to be connected to fluid supply means (e.g., syringe) and to be capped in between uses.

[0090] Reference is now made to Figs. 2A-2C, depicting isometric views of catheter securing umbilical cord clamping device 200, according to some embodiments.

[0091] In some embodiments, catheter securing umbilical cord clamping device 200 may include two elongated parts 210 and 220. Two elongated parts 210 and 220 may be pivotably connected at first end 200’ and may comprise lock means 202 at second end 200”.

[0092] In some embodiments, each of elongated parts 210 and 220 at an inner side may have a first groove 211 and 221 configured to form an opening 201, when in a closed position (as shown in Figs. 2A and 2B), with corresponding first groove 211 or 221 of other elongated part 210 or 220, respectively. Opening 201 may be sized to accommodate umbilical cord 400 so as to apply pressure on umbilical cord 400 while not occluding umbilical catheters 100’ and 100” inserted into blood vessels of umbilical cord 400 (as shown in Fig. 2A).

[0093] In some embodiments, at least one of elongated parts 210 and 220 includes at an outer side a pair of second grooves 213’, 213” and 223’, 223” respectively. Grooves 213’, 213” and 223’, 223” may be sized to accommodate and secure loose ends of umbilical catheters 100’ and 100”, as shown in Fig. 2A.

[0094] The illustrated way of securing umbilical catheters 100’ and 100” by securing them in one groove 213 ’or 223’ of the pair in one direction, and then securing in another groove 213” or 223” of the pair in another direction, creates a strong connection and further prevents dislodgement of catheters 100’ and 100”.

[0095] In some embodiments, first grooves 211 and 221 are at least partially coarse- textured, in order to further resist the relative motion of catheter securing clamping device 200 and the umbilical cord 400.

[0096] In order to further ensure securing of umbilical catheters 100’ and 100” in second grooves 213’, 213” and 223’, 223”, respectively, in some embodiments, grooves 213’, 213”, 223’, and 223” may include inwardly projected lips 214”, 224’, 224”. Lips 214”, 224’, 224” may be configured so as to prevent dislodgement of loose ends of umbilical catheters 100’ and 100” when accommodated in respective second groove 213 ’ , 213 ” , 223 ’ , or 223”.

[0097] Therefore, the claimed invention provides yet another additional improvement of the technological field of neonatal intensive care by suggesting an umbilical catheter clamping device (e.g., device 200), that can be used to properly secure umbilical catheters (e.g., catheters 100, 100’, or 100”) with respect to the umbilical cord right after insertion, thereby preventing their undesired dislodgement, and allowing to put the infant in the prone position and not disturb him further while performing other manipulations with the umbilical catheters.

[0098] Reference is now made to Figs. 3A-3C, depicting isometric views of umbilical cord slitting device 300, according to some embodiments, wherein slitting device 300 has two sharpened edges 323’ and 323”. Reference is also made to Figs. 3D-3F, depicting isometric views of umbilical cord slitting device 300, according to some embodiments, wherein slitting device 300 includes additional slitting wings 313 and 324, thereby having four sharpened edges 323’, 323”, 313’ and 324’.

[0099] In some embodiments, slitting device 300 may include first elongated part 310 and second elongated part 320. First and second elongated parts 310 and 320 may be pivotably connected at first end 300’ and may have lock means 301 at second end 300”. In some embodiments, second elongated part 320 may include sharpened edges 323’ and 323”. Edges 323 ’ and 323 ” may be angled in relation to a transverse direction of second elongated part 320 and project outwardly therefrom, thereby forming cutting point 302.

[0100] In some embodiments, each of first and second elongated parts 310 and 320 at an inner side may have grooves 311, 312 and 321 , 322, respectively, extending in the transverse direction of a respective elongated part 310 and 320. Grooves 311 and 312 may be configured to form, in a closed position, with corresponding grooves 321 and 322, openings 303’ and 303” (as shown in Fig. 3B, 3D and 3E), sized to accommodate umbilical catheters 100’ and 100”, so as to provide unobstructed movement of umbilical cord slitting device 300 along umbilical catheters 100’ and 100”.

[0101] In some embodiments, umbilical cord slitting device 300 may be configured so as to have openings 303’ and 303” positioned in the slitting plane (as it is shown in Figs. 3A-3F). In such embodiments, it is easy to release catheters 100’ and 100” out of strips 400’, obtained after slitting umbilical cord 400. Otherwise, catheters 100’ and 100” may pass through strips 400’, and it may be harder to release them.

[0102] In some embodiments, second elongated part 320 may include handle 304.

[0103] As shown in Figs. 3D-3F, in some embodiments, first and second elongated parts 310 and 320 may further include additional slitting wings 313 and 324 projecting perpendicularly from the outer side of a respective elongated part 310 and 320. Additional slitting wings 313 and 324 may include sharpened edges 313’ and 324’, accordingly. Sharpened edges 313’ and 324’ may be angled in relation to a transverse direction of respective elongated part 310 and 320 and project outwardly therefrom, thereby forming, together with sharpened edges 323’ and 323”, in the closed position (shown in Figs. 3D and 3E), cutting point 302.

[0104] Therefore, the claimed umbilical cord slitting device (e.g., device 300) may be used for slitting a long umbilical stump, into four strips, after umbilical catheters (e.g., catheters 100, 100’ and 100”) are inserted. Then the obtained strips can be easily cut off, and thereby a short umbilical stump may be formed, while the inserted umbilical catheters remain inserted and even positioned as required.

[0105] Reference is now made to Fig. 4 A, depicting the first method of intravascular fluid supply for preterm infants, according to some embodiments.

[0106] As shown in step S 1005, the claimed method may include cutting off an umbilical cord (e.g., umbilical cord 400, as shown in Figs. 2A, 3A and 3C) at a first distance (a longer distance, e.g., 5-30 cm) from an abdominal wall of an infant. Step S1005 may be carried out by using a scalpel.

[0107] As shown in step S1010, the claimed method may further include inserting one or more umbilical catheters (e.g., umbilical catheters 100, 100’ or 100”, as shown in Figs. 1, 2A, 3 A and 3C) through one or more blood vessels of an umbilical stump (e.g., umbilical cord 400, as shown in Figs. 2A, 3A and 3C). Step S1010 may be carried out either by entering through the blood vessel orifice or by puncturing the vessel wall and using Seidinger technique.

[0108] The umbilical vessels are commonly circular and torturous and may collapse very soon after birth. Because of that, inserting the catheter through the vessel into the infant’s body may be hard, and may additionally need a special guide wire for advancing. Furthermore, the claimed methods may involve usage of other tools, e.g., a skin dilator, a string or umbilical tape, a measuring tape, a sterile mat, syringes and needles, corks to close the tubes of the catheter etc.

[0109] In some embodiments, the one or more blood vessels may include an umbilical artery and either of said umbilical catheters (e.g., umbilical catheters 100, 100’ or 100”, as shown in Figs. 1, 2A, 3 A and 3C) may be used as umbilical arterial catheter (UAC). In some embodiments, the one or more blood vessels may include an umbilical vein and either of said umbilical catheters (e.g., umbilical catheters 100, 100’ or 100”, as shown in Figs. 1, 2A, 3A and 3C) may be used as umbilical venous catheter (UVC).

[0110] As shown in step S 1015, the claimed method may further include accommodating loose ends of the one or more umbilical catheters (e.g., umbilical catheters 100, 100’, and 100”, as shown in Figs. 1, 2A, 3A and 3C) in a slitting device (e.g., slitting device 300, as shown in Figs. 3A-3F), wherein the slitting device (e.g., slitting device 300, as shown in Figs. 3A-3F) is configured to slide along the one or more umbilical catheters (e.g., umbilical catheters 100, 100’, and 100”, as shown in Figs. 1, 2A, 3 A and 3C) while maintaining the integrity thereof.

[0111] In some embodiments, the slitting device (e.g., slitting device 300, as shown in Figs. 3A-3F) may include at least one sharpened front edge (e.g., sharpened edges 323’, 323”, 313’, and 324’, as shown in Figs. 3A-3C) and is positioned so as to face an umbilical stump (e.g., umbilical cord 400, as shown in Figs. 2A, 3A and 3C).

[0112] As shown in step S1020, the claimed method may further include moving the slitting device (e.g., slitting device 300, as shown in Figs. 3A-3F) along the one or more umbilical catheters (e.g., umbilical catheters 100, 100’, and 100”, as shown in Figs. 1, 2A, 3A and 3C) towards the abdominal wall up to a second distance (a shorter distance, e.g., 1- 5 cm) from the abdominal wall, thereby slitting the umbilical stump (e.g., umbilical cord 400, as shown in Figs. 2A, 3A and 3C) into strips (e.g., strip 400’, as shown in Fig. 3C). Steps S1015 and S1020 may be carried out by applying umbilical catheters 100, 100’, and 100”, as shown in Figs. 1, 2A, 3A and 3C, and slitting device 300, as shown in Figs. 3A- 3F.

[0113] In some embodiments, the method may further include clamping umbilical stump (e.g., umbilical cord 400, as shown in Figs. 2A, 3A and 3C) with an umbilical cord clamping device (e.g., catheter securing umbilical cord clamping device 200, as shown in Figs. 2A- 2C) at a third distance from the abdominal wall, wherein the third distance is shorter than the second distance. The umbilical cord clamping device (e.g., catheter securing umbilical cord clamping device 200, as shown in Figs. 2A-2C) may be configured to clamp the umbilical cord (e.g., umbilical cord 400, as shown in Figs. 2A, 3A and 3C) so as to apply pressure on the umbilical cord (e.g., umbilical cord 400, as shown in Figs. 2A, 3A and 3C) while not occluding the one or more umbilical catheters (e.g., umbilical catheters 100, 100’, and 100”, as shown in Figs. 1, 2A, 3 A and 3C).

[0114] In some embodiments of the method, the umbilical cord clamping device may include at least one groove (e.g., grooves 213’, 213”, 223’, and 223”, as shown in Figs. 2A- 2C), sized to secure loose ends of the one or more umbilical catheters (e.g., umbilical catheters 100, 100’, and 100”, as shown in Figs. 1, 2A, 3A and 3C). The method may further include securing loose ends of the one or more umbilical catheters (e.g., umbilical catheters 100, 100’, and 100”, as shown in Figs. 1, 2A, 3A and 3C) to the umbilical cord clamping device (e.g., as shown in Fig. 2A).

[0115] As shown in step S1025, the claimed method may further include cutting off the strips (e.g., strip 400’, as shown in Fig. 3C) at the second distance from the abdominal wall. Step S1025 may be carried out by using a scalpel.

[0116] As shown in step S1030, the claimed method may further include supplying a fluid via the one or more umbilical catheters (e.g., umbilical catheters 100, 100’, and 100”, as shown in Figs. 1, 2A, 3 A and 3C).

[0117] Reference is now made to Fig. 4B, depicting the second method of intravascular fluid supply for preterm infants, according to some embodiments.

[0118] As shown in step S2005, the claimed method may include cutting off an umbilical cord (e.g., umbilical cord 400, as shown in Figs. 2A, 3A and 3C) at a first distance (a longer distance, e.g., 5-30 cm) from an abdominal wall of an infant. Step S2005 may be carried out by using a scalpel.

[0119] As shown in step S2010, the claimed method may include inserting one or more umbilical catheters (e.g., umbilical catheters 100, 100’ or 100”, as shown in Figs. 1, 2A, 3A and 3C) through one or more blood vessels of an umbilical stump (e.g., umbilical cord 400,as shown in Figs. 2A, 3A and 3C), wherein each of the one or more umbilical catheters (e.g., umbilical catheters 100, 100’ or 100”, as shown in Figs. 1, 2A, 3 A and 3C) may include at least one protected portion (e.g., protected portion 101, as shown in Fig. 1 A) at least partially covered with a hard covering; and wherein each of the one or more umbilical catheters (e.g., umbilical catheters 100, 100’ or 100”, as shown in Figs. 1, 2A, 3A and 3C) may be inserted so as to have the at least one protected portion (e.g., protected portion 101, as shown in Fig. 1A) positioned at a second distance (e.g., 1-5 cm) from the abdominal wall. Step S2010 may be carried out by using umbilical catheters 100, 100’ or 100”, as shown in Figs. 1, 2A, 3A and 3C.

[0120] In some embodiments, said hard covering may be made movable along the catheter and the method may further include advancing the hard covering along the catheter (e.g., umbilical catheters 100, 100’ or 100”, as shown in Figs. 1, 2A, 3A and 3C) so as to position the hard covering at the second distance (e.g., 1-5 cm) from the abdominal wall. In some embodiments, the hard covering may be made dark colored, and the method may further include transilluminating the umbilical stump (e.g., umbilical cord 400, as shown in Figs. 2A, 3A and 3C) to determine the position of the hard covering within the respective blood vessel.

[0121] In some embodiments, the one or more blood vessels may include an umbilical artery and either of said umbilical catheters (e.g., umbilical catheters 100, 100’ or 100”, as shown in Figs. 1, 2A, 3 A and 3C) may be used as umbilical arterial catheter (UAC). In some embodiments, the one or more blood vessels may include an umbilical vein and either of said umbilical catheters (e.g., umbilical catheters 100, 100’ or 100”, as shown in Figs. 1, 2A, 3A and 3C) may be used as umbilical venous catheter (UVC).

[0122] In some embodiments, the one or more umbilical catheters (e.g., umbilical catheters 100, 100’ or 100”, as shown in Figs. 1, 2A, 3A and 3C) may include: at least one inflatable envelope (e.g., inflatable envelope 120, as shown in Fig. 1 A); at least one first tube (e.g., first tube 110, as shown in Fig. 1 A) passing through the at least one inflatable envelope (e.g., inflatable envelope 120, as shown in Fig. 1 A) and having at least one first fluid supply lumen (e.g., first fluid supply lumen 110’, as shown in Fig. 1A); and at least one second tube (e.g., second tube 130, as shown in Fig. 1 A) having a second fluid supply lumen (e.g., second fluid supply lumen 130’, as shown in Fig. 1 A) in fluid connection to the at least one inflatable envelope (e.g., inflatable envelope 120, as shown in Fig. 1A).

[0123] In some embodiments, supplying the fluid via the one or more umbilical catheters (e.g., umbilical catheters 100, 100’ or 100”, as shown in Figs. 1, 2A, 3A and 3C) may include supplying the fluid via a respective at least one first tube (e.g., first tube 110, as shown in Fig. 1A). In some embodiments, inserting the one or more umbilical catheters (e.g., umbilical catheters 100, 100’ or 100”, as shown in Figs. 1, 2A, 3A and 3C) through the one or more blood vessels may be performed in a deflated state, and the method may further include inflating the at least one inflatable envelope (e.g., inflatable envelope 120, as shown in Fig. 1A) of the one or more umbilical catheters (e.g., umbilical catheters 100, 100’ or 100”, as shown in Figs. 1, 2A, 3A and 3C) to occlude a respective blood vessel, thereby securing the umbilical catheter therein.

[0124] In some embodiments, prior to inserting the one or more umbilical catheters (e.g., umbilical catheters 100, 100’ or 100”, as shown in Figs. 1, 2A, 3 A and 3C) through the one or more blood vessels, the method may further include setting the inflatable envelope (e.g., inflatable envelope 120, as shown in Fig. 1A) at the desired distance from the proximal end of the first tube (e.g., 10-25 cm for UAC and 5-15 cm for UVC) (e.g., first tube 110, as shown in Fig. 1 A), according to the size of the infant (as it is discussed with reference to Fig. 1A).

[0125] In some embodiments, the at least one first tube (e.g., first tube 110, as shown in Fig. 1A) and the at least one inflatable envelope (e.g., inflatable envelope 120, as shown in Fig. 1A) are made of materials having different transparency or coloring. In some embodiments, inserting the one or more umbilical catheters (e.g., umbilical catheters 100, 100’ or 100”, as shown in Figs. 1, 2A, 3A and 3C) may further include: transilluminating the umbilical stump (e.g., umbilical cord 400, as shown in Figs. 2A, 3A and 3C) to determine a position of the at least one inflatable envelope (e.g., inflatable envelope 120, as shown in Fig. 1 A) within the respective blood vessel; and positioning the at least one protected portion (e.g., protected portion 101, as shown in Fig. 1A) at the second distance from the abdominal wall, based on the determined position.

[0126] In some embodiments, the method may further include clamping the umbilical stump (e.g., umbilical cord 400, as shown in Figs. 2A, 3A and 3C), with an umbilical cord clamping device (e.g., catheter securing umbilical cord clamping device 200, as shown in Figs. 2A-2C) at a third distance from the abdominal wall, wherein the third distance is shorter than the second distance. In particular, according to some embodiments, said thirddistance may be between the inflatable envelope (e.g., inflatable envelope 120, as shown in Fig. 1A) of the one or more umbilical catheters (e.g., umbilical catheters 100, 100’ or 100”, as shown in Figs. 1, 2A, 3 A and 3C) and the abdominal wall, e.g., slightly proximal to the inflatable envelope (e.g., inflatable envelope 120, as shown in Fig. 1A).

[0127] In some embodiments, the umbilical cord clamping device (e.g., catheter securing umbilical cord clamping device 200, as shown in Figs. 2A-2C) may include at least one groove (e.g., grooves 213’, 213”, 223’, and 223”, as shown in Figs. 2A-2C), sized to secure loose ends of the one or more umbilical catheters (e.g., umbilical catheters 100, 100’ or 100”, as shown in Figs. 1, 2A, 3A and 3C); and the method may further include securing loose ends of the one or more umbilical catheters (e.g., umbilical catheters 100, 100’ or 100”, as shown in Figs. 1, 2A, 3A and 3C) to the umbilical cord clamping device (e.g., catheter securing umbilical cord clamping device 200, as shown in Figs. 2A-2C).

[0128] As shown in step S2015, the claimed method may include cutting off the umbilical cord (e.g., umbilical cord 400, as shown in Figs. 2A, 3A and 3C) at the second distance from the abdominal wall around the at least one protected portion (e.g., protected portion 101, as shown in Fig. 1A). Step S2015 may be carried out by using a scalpel.

[0129] In some embodiments, the method may further include clamping the umbilical stump (e.g., umbilical cord 400, as shown in Figs. 2A, 3A and 3C) with the umbilical cord clamping device (e.g., catheter securing umbilical cord clamping device 200, as shown in Figs. 2A-2C) at a fourth distance from the abdominal wall, wherein the fourth distance is between the second distance and the inflatable envelope (e.g., inflatable envelope 120, as shown in Fig. 1 A) of the respective one or more umbilical catheters (e.g., umbilical catheters 100, 100’ or 100”, as shown in Figs. 1, 2A, 3A and 3C). E.g., said clamping may be done slightly distal to the inflatable envelope (e.g., inflatable envelope 120, as shown in Fig. 1A).

[0130] As shown in step S2020, the claimed method may further include supplying a fluid via the one or more umbilical catheters (e.g., umbilical catheters 100, 100’, and 100”, as shown in Figs. 1, 2A, 3A and 3C).

[0131] As can be seen from the provided description, the claimed invention represents methods of intravascular fluid supply for preterm infants and devices for performing such methods, which require less infant handling and, furthermore, less time for performing manipulations with an infant staying in an open incubator, thereby providing an improvement of the technological field of neonatal intensive care.

[0132] Unless explicitly stated, the method embodiments described herein are not constrained to a particular order or sequence. Furthermore, all formulas described herein are intended as examples only and other or different formulas may be used. Additionally, some of the described method embodiments or elements thereof may occur or be performed at the same point in time.

[0133] Reference is now made to Fig. 5 which is an illustration of a system according to some embodiments, when in use. As illustrated, an umbilical catheter 500 (or umbilical catheters 100, 100’, and 100”, as shown in Figs. 1, 2A, 3A and 3C), may be introduced, through an insertion point 502 through blood vessels in umbilical cord (e.g., umbilical cord 400, as shown in Figs. 2A, 3A and 3C). It should be appreciated that insertion point should be located in a sterile field surrounding the insertion point from all directions.

[0134] According to some embodiments, umbilical catheter 500 may include first tube 110 having first fluid supply lumen (110’ in Figs 1A and IB). Umbilical catheter 500 may further include inflatable envelope (120 in Figs. 1A and IB), enveloping first tube 110 and sized to be movable along first tube 110 in a deflated state and to be secured inside the umbilical stump in an inflated state.

[0135] In some embodiments, a standard umbilical clamp 508 (not to be confused with the catheter securing umbilical cord clamping device 200 in Figs 2A-2C) may be placed along the umbilical cord at a distance from the abdominal wall leaving a stump sufficiently long to allow the introduction of the at least one catheter through the umbilical stump as described above. For example, standard umbilical clamp 508 may be placed at least 10 cm from the abdominal wall of preterm infant 505. According to some embodiments, clamp 508 may be placed between 10 and 50 cm from abdominal wall, between 15 and 25 cm, and the like. The long cord segment may enable a significant distance between the abdominal wall and the insertion point. This unnecessitates cleaning the abdominal wall, and in some cases the cord can be even taken out from a small opening in a neonatal incubator, enabling having the sterile field outside the incubator that can remain closed during the procedure.

[0136] While certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents may occur to those skilled in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.

[0137] Various embodiments have been presented. Each of these embodiments may of course include features from other embodiments presented, and embodiments not specifically described may include various features described herein.

Claims

CLAIMS1. An umbilical catheter, comprising: a first tube (102) having at least one first fluid supply lumen; at least one inflatable envelope (101), enveloping the first tube and sized to be movable along the first tube in a deflated state and to be secured inside an umbilical stump in an inflated state; and at least one second tube (103) having a second fluid supply lumen in fluid connection to the at least one inflatable envelope (101).

2. The umbilical catheter of claim 1, wherein the umbilical catheter is sized to be inserted into a blood vessel of an umbilical cord in the deflated state and to occlude the blood vessel in the inflated state, while maintaining the integrity of the blood vessel.

3. The umbilical catheter according to any one of claims 1-2, further comprising distance markings on the first tube, indicating distance from the proximal end thereof.

4. The umbilical catheter according to any one of claims 1-3, further comprising at least one dent portion along the first tube, sized to accommodate the at least one inflatable envelope (101) in the inflated state.

5. The umbilical catheter according to any one of claims 1-4, further comprising at least one protected portion (102’) at least partially covered with a hard covering.

6. The umbilical catheter according to any one of claims 1-5, wherein the hard covering is made of or containing a metal.

7. The umbilical catheter according to any one of claims 1-6, further comprising: a plurality of inflatable envelopes arranged successively along the first tube; and a plurality of second tubes, each having the second fluid supply lumen in fluid connection to a respective inflatable envelope of the plurality of inflatable envelopes.

8. The umbilical catheter according to any one of claims 1-7, wherein the first tube and the at least one inflatable envelope are made of materials having different transparency.

9. The umbilical catheter according to any one of claims 1-8, wherein the first tube and the at least one inflatable envelope are made of materials having different coloring.

10. The umbilical catheter according to any one of claims 1-9, wherein the length of the first tube is 15-40 cm, and the diameter is 3-10 Fr.

11. The umbilical catheter according to any one of claims 1-10, wherein the diameter of the at least one inflatable envelope in the deflated state is 3.5-11 Fr and in the inflated state is 5-10 mm.

12. An umbilical cord clamping device (200), comprising two elongated parts (210, 220), said two elongated parts (210, 220) being pivotably connected at a first end (200’) and comprising lock means (202) at a second end (200”); wherein each of the elongated parts (210, 220) at an inner side comprises a first groove (211, 221) configured to form, in a closed position, with a corresponding first groove (211, 221) of the other elongated part (210, 220), an opening (201), sized to accommodate an umbilical cord (400) so as to apply pressure on the umbilical cord (400) while not occluding an umbilical catheter (100’, 100”) inserted into blood vessel of the umbilical cord (400); and wherein at least one of the elongated parts (210, 220) comprises at an outer side at least one second groove (213’, 223’, 223”) sized to accommodate and secure a loose end of the umbilical catheter (100’, 100”).

13. The umbilical cord clamping device of claim 12, wherein the first groove is at least partially coarse textured.

14. The umbilical cord clamping device according to any one of claims 12-13, comprising a pair of second grooves (223’, 223”) on the outer side of at least one of the elongated parts.

15. The umbilical cord clamping device according to any one of claims 12-14, wherein the at least one second groove (213’, 223 ’ , 223 ’ ’) comprises at least one inwardly projected lip (224’, 224”), configured to prevent dislodgement of the loose end of the umbilical catheter when accommodated in the at least one second groove.

16. The umbilical cord clamping device according to any one of claims 12-15, wherein the length of each elongated part is 1-5 cm.

17. An umbilical cord slitting device (300), comprising:a first elongated part (310); and a second elongated part (320); said first and second elongated parts (310, 320) being pivotably connected at a first end (300’) and comprising lock means (301) at a second end (300”); wherein at least one of the first and second elongated parts (310, 320) comprises one or more sharpened edges (322’, 322”), wherein said edges are angled in relation to a transverse direction of a respective elongated part (310, 320) and project outwardly therefrom, thereby forming a cutting point (302); wherein each of said first and second elongated parts (310, 320) at an inner side comprises at least one groove (311, 321) extending in the transverse direction of a respective elongated part (310, 320), wherein said at least one groove (311, 321) is configured to form, in a closed position, with a corresponding groove (311, 321) of the other elongated part (310, 320), an opening (303’, 303”), sized to accommodate an umbilical catheter (100’, 100”) so as to provide unobstructed movement of the device along the umbilical catheter (100’, 100”).

18. The umbilical cord slitting device of claim 17, wherein at least one of the first and second elongated parts (310, 320) further comprises an additional slitting wing (313, 323) projecting perpendicularly from the outer side of a respective elongated part (310, 320); wherein said additional slitting wing (313, 323) comprises a sharpened edge (313’, 323’) angled in relation to a transverse direction of the respective elongated part (310, 320) and projecting outwardly therefrom, thereby forming, together with the other sharpened edges (322’, 322”), in the closed position, the cutting point (302).

19. The umbilical cord slitting device according to any one of claims 17-18, wherein at least one of the first and second elongated parts (310, 320) comprises a handle (304).

20. The umbilical cord slitting device according to any one of claims 17-19, wherein the length of each of said one or more sharpen edges is 1-3 cm.

21. The umbilical cord slitting device according to any one of claims 17-20, wherein the length of said additional slitting wing is 1-3 cm.

22. The umbilical cord slitting device according to any one of claims 17-21, wherein the length of said handle is 3-15 cm.

23. The umbilical cord slitting device according to any one of claims 17-22, wherein the diameter of said opening is 1-3 mm.

24. A method of intravascular fluid supply for preterm infants, the method comprising: cutting off an umbilical cord at a first distance from an abdominal wall of an infant; inserting one or more umbilical catheters through one or more blood vessels of an umbilical stump; accommodating loose ends of the one or more umbilical catheters in a slitting device, wherein the slitting device is configured to slide along the one or more umbilical catheters while maintaining the integrity thereof; moving the slitting device along the one or more umbilical catheters towards the abdominal wall up to a second distance from the abdominal wall, thereby slitting the umbilical stump into strips; cutting off the strips at the second distance from the abdominal wall; and supplying a fluid via the one or more umbilical catheters.

25. The method of claim 24, wherein the one or more blood vessels comprise an umbilical artery and wherein the one or more umbilical catheters comprise an umbilical arterial catheter (UAC).

26. The method according to any one of claims 24-25, wherein the one or more blood vessels comprise an umbilical vein and wherein the one or more umbilical catheters comprise an umbilical venous catheter (UVC).

27. The method according to any one of claims 24-26, wherein the slitting device comprises at least one sharpened front edge and is positioned so as to face an umbilical stump.

28. The method according to any one of claims 24-27, further comprising clamping umbilical stump with an umbilical cord clamping device at a third distance from the abdominal wall, wherein the third distance is shorter than the second distance.SUBSTITUTE SHEET (RULE 26)29. The method according to any one of claims 24-28, wherein the umbilical cord clamping device is configured to clamp the umbilical cord so as to apply pressure on the umbilical cord while not occluding the one or more umbilical catheters.

30. The method according to any one of claims 24-29, wherein the umbilical cord clamping device comprises at least one groove, sized to secure loose ends of the one or more umbilical catheters; and the method further comprises securing loose ends of the one or more umbilical catheters to the umbilical cord clamping device.

31. A method of intravascular fluid supply for preterm infants, the method comprising: cutting off an umbilical cord at a first distance from an abdominal wall of an infant; inserting one or more umbilical catheters through one or more blood vessels of an umbilical stump, wherein each of the one or more umbilical catheters comprise at least one protected portion at least partially covered with a hard covering; and wherein each of the one or more umbilical catheters are inserted so as to have the at least one protected portion positioned at a second distance from the abdominal wall; cutting off the umbilical cord at the second distance from the abdominal wall around the at least one protected portion; and supplying a fluid via the one or more umbilical catheters.

32. The method of claim 31, wherein the one or more blood vessels comprise an umbilical artery and wherein the one or more umbilical catheters comprise an umbilical arterial catheter (UAC).

33. The method according to any one of claims 31-32, wherein the one or more blood vessels comprise an umbilical vein and wherein the one or more umbilical catheters comprise an umbilical venous catheter (UVC).

34. The method according to any one of claims 31-33, wherein the hard covering is made of or containing a metal.

35. The method according to any one of claims 31-34, wherein the one or more umbilical catheters comprise: at least one inflatable envelope;at least one first tube passing through the at least one inflatable envelope and having at least one first fluid supply lumen; and at least one second tube having a second fluid supply lumen in fluid connection to the at least one inflatable envelope; and wherein supplying the fluid via the one or more umbilical catheters comprises supplying the fluid via a respective at least one first tube; wherein inserting the one or more umbilical catheters through the one or more blood vessels is performed in a deflated state; and wherein the method further comprises inflating the at least one inflatable envelope of the one or more umbilical catheters to occlude a respective blood vessel, thereby securing the umbilical catheter therein.

36. The method according to any one of claims 31-35, wherein the at least one first tube and the at least one inflatable envelope are made of materials having different transparency or coloring; and wherein inserting the one or more umbilical catheters further comprises: transilluminating the umbilical stump to determine a position of the at least one inflatable envelope within the respective blood vessel; and positioning the at least one protected portion at the second distance from the abdominal wall, based on the determined position.

37. The method according to any one of claims 31-36, further comprising clamping the umbilical stump with an umbilical cord clamping device at a third distance from the abdominal wall, wherein the third distance is shorter than the second distance.

38. The method according to any one of claims 31-37, wherein said third distance is between the inflatable envelope of the one or more umbilical catheters and the abdominal wall.

39. The method according to any one of claims 31-38, wherein the umbilical cord clamping device is configured to clamp the umbilical cord so as to apply pressure on the umbilical cord while not occluding the one or more umbilical catheters.

40. The method according to any one of claims 31-39 wherein the umbilical cord clamping device comprises at least one groove, sized to secure loose ends of the one ormore umbilical catheters; and the method further comprises securing loose ends of the one or more umbilical catheters to the umbilical cord clamping device.

41. The method according to any one of claims 31-40, wherein the method further comprises clamping the umbilical stump with the umbilical cord clamping device at a fourth distance from the abdominal wall, wherein the fourth distance is between the second distance and the inflatable envelope of the respective one or more umbilical catheters.

42. The method according to any one of claims 31-41, wherein the one or more umbilical catheters comprise: a first tube having at least one first fluid supply lumen; an inflatable envelope, enveloping the at least one first tube and sized to be movable along the at least one first tube in a deflated state and to be secured thereto in an inflated state; and a second tube having a second fluid supply lumen in fluid connection to the inflatable envelope; wherein supplying the fluid via the one or more umbilical catheters comprises supplying the fluid via the first tube; wherein inserting the one or more umbilical catheters through the one or more blood vessels is performed in a deflated state; and wherein the method further comprises: prior to inserting the one or more umbilical catheters through the one or more blood vessels, setting the inflatable envelope at the desired distance from the proximal end of the first tube; inflating the inflatable envelope of the one or more umbilical catheters to occlude a respective blood vessel, thereby securing the umbilical catheter therein; and clamping the umbilical stump with umbilical cord clamping devices, distal and proximal to the inflatable envelope.

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