EP0935481A1

EP0935481A1 - Connector assembly for collecting fluids

Info

Publication number: EP0935481A1
Application number: EP97937569A
Authority: EP
Inventors: Valter Paderni
Original assignee: CRB Nederland BV
Current assignee: CRB Nederland BV
Priority date: 1996-08-16
Filing date: 1997-08-12
Publication date: 1999-08-18
Also published as: IT1288974B1; ITUD960160A1; WO1998007466A1; AU4014897A

Abstract

A connector assembly for collecting fluids, including a central hollow body (300) adapted to accommodate and lock the cut end portion of the umbilical cord or other vessel or tube; a coupling device (7) for hermetically coupling the central body (300) to a collection apparatus; a sealing device (8) for hermetically sealing the cord, vessel or tube and an outer surface of the central body (300).

Description

CONNECTOR ASSEMBLY FOR COLLECTING FLUIDS Technical Field

The present invention relates to a connector assembly for collecting fluids. In particular, the connector assembly is aαapted to connect the cut end portion of the umbilical cord, or of vessels, or of a hollow tube, having a variable cross-section with soft and elastic walls having a loose and easily collapsible consistency, to a container for collecting blood, or other fluids, from the placenta or another organ or part of an organ or another container, as stated in the main claim. Background Art The assembly according to the invention is used mainly in the biological, medical and veterinary field both for diagnostic and therapeutic purposes and for research purposes, for the collection of blood or other fluids from the placenta or another organ or part of an organ or other container, to be used subsequently as a source of cells, molecules or other.

In particular, the connector assembly according to the invention is used during childbirth, after neonatal expulsion, to collect placental blood, i.e., the blood that is present in the placenta, which is drained froπ the umbilical cord. By virtue of the connector assembly according to the invention it is possible to connect the cut end portion of the umbilical cord to a collection container so that blood collection occurs m a sterile environment and so as to facilitate maneuvers, such as for example expression of the umbilical cord, which are suitable to increase the amount of recovered blood. Furthermore, the use of the invention does not require particular skill or capability of the operator and does not expose the operator, the mother or the neonate to the risk of accidental punctures. In the biological, medical and veterinary fields it is necessary to collect fluids, particularly blood, from organs or tissues or containers in general, both for diagnostic and therapeutic purposes and for research purposes. Two non- limitative examples are: 1. the collection of blood from masses of tumoral tissue, since the blood contained in the tumoral tissue is potentially useful for therapeutic purposes after appropriate treatment; 2. the collection of blood from the placenta during childbirth directly after cutting the umbilical cord. In this second case, the blood is useful since it contains stem cells, which are hematopoietic precursor cells, i.e., cells which are capable of reconstituting the hematopoietic system and therefore can be used, if the need arises, for transplanting to the same donor or to another compatible recipient. The procedures currently used to collect placental blood from an umbilical cord are described hereinafter as a typical example of the recovery of fluids from an organ; it is important to note that the reference to this practice is not limitative and is merely an example of situations in which it is necessary to collect blood or another fluid from tissues, organs or other containers in general.

Placental blood from the umbilical cord is collected because it contains hematopoietic stem cells which can be used for transplants. To allow the collected blood and therefore the recovered cells to be truly and successfully usable, the following conditions must be met: 1. the largest possible amount of blood, i.e., the highest possible number of cells, must be recovered; 2. the collected blood, which is fetal in origin, must not be contaminated by foreign cell populations, such as for example maternal cells; 3. during collection, contact of the blood with the outside (air or other potentially contaminated objects) must be minimized, or the collection procedure must occur in sterile conditions, possibly in a closed environment; 4. the possibility of human error must be minimized. Steps of collection a. Before expulsion of the placenta.

Blood is currently extracted from the placenta in the medical field, both for diagnostic and therapeutic purposes and for research purposes, as follows: during childbirth, directly after the expulsion of the newborn child, the umbilical cord is closed (clamped) in two points and cut in a point which is intermediate between the two closure points. After cutting, the cut end of the umbilical cord which is connected to the placenta protrudes freely from the mother's vagina and is available for collection operations. Typically, blood is collected in the period between the cutting of the umbilical cord and expulsion of the placenta. During this period, the flow of blood is ensured by the pressure generated by uterine contractions, which by compressing the placenta facilitate the outflow of blood through the umbilical cord, b. After expulsion of the placenta.

Only a small number of authors reports collection procedures which provide for cord blood collection after expulsion of the placenta by placing the placenta on a frame and collecting the blood by gravity. The limited use of collection after expulsion of the placenta is certainly due to the low yield of collection by gravity and to difficulty in handling the placenta, especially when the sterility of the collected blood must be guaranteed. Collection systems

Collection of placental blood from the umbilical cord in the medical field, both for diagnostic and therapeutic purposes and for research purposes, is currently performed with methods which can be traced back to two categories: "open-circuit" systems and "closed-circuit" systems. Both systems are used for collection both before and after expulsion of the placenta. a. "Open-circuit" systems

"Open-circuit" systems collect placental blood from the cut umbilical cord in containers which contain anticoagulant. This collection is performed by making the blood flow out directly into the collection container without connecting the end portion of the cord, which is placed loosely at the inlet of the container. Advantages The main advantage of this system is the absence of resistances to flow, since there are no bottlenecks or sudden decreases in cross-section of the cord and of its vessels .

A second advantage is that the three vessels which are present n the umbilical cord are simultaneously pervious.

Another advantage of the system is the possibility to express the umbilical cord during collection. Disadvantages

Various scientific papers have demonstrated that "open- circuit" systems do not ensure sterility and are in fact associated with a particularly high incidence of microbial contaminations. The cut end portion of the umbilical cord in fact has a loose consistency, and since it is simply rested on the inlet of the collecting container it can easily escape from it, consequently contaminating said end portion in addition to losing blood, which contaminates the outside environment . Furthermore, the system inherently (being an "open" system) collects both the blood that flows out of the vessels of the cord and potentially contaminated liquids which flow along the outer surface of the umbilical cord; in particular, the maternal blood which is abundantly present along the outer surface of the placenta flows along the cord and mixes with the blood of the umbilical cord.

This collection system furthermore exposes the blood to the air of the outside environment, thus facilitating contaminations by microorganisms which are present in the outside environment.

Another drawback is the constant need for an operator assigned to keeping the umbilical cord in the correct position, particularly if repeated maneuvers for expressing and cleaning the cord are performed. b. "Closed-circuit" systems Collection is performed by venipuncture of the cut and clamped end of the umbilical cord, after accurately disinfecting the entry point of the needle. The blood is collected in one or more syringes or in donation pouches. Advantages

With respect to "open-circuit" systems, "closed- circuit" systems reduce the risks of microbial contamination of the collected blood and do not require continuous cleaning and disinfection of the cord. Another advantage is reduction of the contamination of the sample with maternal blood or other liquids which flow along the outer surface of the cord. Disadvantages

"Closed-circuit" systems entail handling needles and therefore expose the operators to the r sk of accidental punctures.

Furthermore, the needle inserted in the umbilical vein is not stably fixed to it and can easily come loose, also in view of the highly dynamic nature of childbirth; this problem is particularly felt if collection is continued even after expulsion of the placenta. Accordingly, the continuous presence of an operator is required to ensure the correct placement of the needle during the various steps of collection.

If the needle leaves its seat, blood contaminations and accidental punctures of the operator are possible, and repetition of venipuncture is furthermore required in order to continue collection.

Owing to the limited cross-section of two of the three vessels of the umbilical cord (the arteries), collection is feasible only on one vessel (the vein), consequently reducing the collection potential.

The flow of blood is furthermore hindered by the sudden decrease in cross-section (the needle, no matter how large, can never have the same cross-section as the umbilical vein) .

The needle is inserted in an intermediate segment of the umbilical cord, upstream of the closure region; stasis of the blood downstream of the insertion point, with a consequent tendency to clotting, is thus inevitable; moreover, the blood which remains downstream of the insertion point is not recovered. Disclosure of the Invention

An aim of the present invention is to provide a connector assembly for collecting fluids that overcomes the drawbacks of the cited prior art.

An further aim of the invention is to provide a connector assembly adapted to connect, in a sterile, practical and quick manner, the end portion of the umbilical cord or of vessels or of a hollow tube having a variable cross-section, with soft and elastic walls and having a loose and easily collapsible consistency, to a collection container by means of a closed system, which optionally contains anticoagulant or another liquid or is connected to another container and/or dispenser of anticoagulant or other liquid, such that the blood or other fluid drained from the umbilical cord or vessel or tube passes into the collection container in sterile conditions, without making contact with the outside. The above aims, and other aims that will become apparent to those skilled in the art, are achieved by a connector assembly for collecting fluids as claimed in the appended claims. Brief description of the drawings Further characteristics and advantages of the invention will become apparent from a reading of the detailed description of preferred but not exclusive embodiments of the invention, illustrated only by way of a non-limiting example in the accompanying drawings, wherein:

FIG. 1 is a side view of an anchoring device for anchoring the cut end portion of the umbilical cord, or of vessels, or a hollow tube, shown in an inactive position;

FIG. 2 is a side view of an anchoring device for anchoring the cut end portion of the umbilical cord, or of vessels, or a hollow tube, shown in an active position;

FIG. 3 s a side elevated view of the central body for accommodating and locking the cut end portion of the umbilical cord or of vessels or of a hollow tube; FIG. 4 is a top view of the central body of FIG. 3;

FIG. 5 is a section view according to the section line V-V of FIG. 4;

FIG. 6 is a side view of the cutting device for cutting the umbilical cord, or vessels, or hollow tube; FIG. 7 is a section view according to the section line II-VII of

FIG. 8 is a side view of a disinfecting and cleaning device;

FIG. 9 is a section view according to the section line IX-IX of FIG. 8;

FIGs. 10-12 are side views of the assembly according to the invention shown in three successive steps of the operation of the assembly;

FIG. 13 is a schematic side elevated view of a system for applying pressure to the placenta and optionally to the umbilical cord, using the connector assembly according to the present invention.

Ways of carrying out the Invention

With reference to the drawings, the collector assembly according to the invention, globally designated by the reference numeral 100, comprises six elements.

An anchoring device 200 for anchoring the cut end portion of the umbilical cord.

The anchoring device 200 has the purpose of anchoring the cut end portion of the umbilical cord or other vessel or tube and conveying it through the central body of the connector assembly according to the invention for subsequent positioning and locking.

In the exemplifying and non-limitative system shown in FIGs. 1 and 2, the anchoring system is constituted by four optionally pointed curved elements 1 which are fixed to one end of an element 3 which passes through the central body and has, at the opposite end, a tip 4 which can be grasped by a hand. A sheath 2 can slide along the longitudinal axis of the system and modifies the position of the curved elements from an inactive position, which allows to accommodate the end portion of the cord between said curved elements, to a "closed" position, which allows to fix and firmly anchor the end portion of the umbilical cord or other vessel or tube. In the inactive position (FIGs. l and 10), the anchoring system passes through the central body of the connector assembly, so that the anchoring elements protrude from the end from which the cord enters the central body and so that the tip that can be grasped protrudes from the opposite end portion 31. After anchoring, the umbilical cord is conveyed through the central body of the connector assembly according to the invention for subsequent positioning and locking.

A central body 300 for accommodating and locking the cut end portion of the umbilical cord.

The central body 300 has the function of locking the end portion of the umbilical cord or other vessel or tube once it has been positioned by means of the above described anchoring system. The central body can optionally have an access path leading to the internal space for connection to another container and/or dispenser of anticoagulant or other liquid or an access path for drawing part of the blood or fluid during collection.

In the non-limitative example shown in FIGs. 3-5, the central body is composed of a hollow cylinder 5 which has appropriately selected length and diameters so as to allow the passage of the umbilical cord or other vessel or tube. Orientated means 6 protrude from the inner walls and allow the cord or vessel or tube to slide freely in one direction but lock it if it is pulled in the opposite direction. In the example shown in FIGs. 3-5 said means are represented by pointed metallic structures which protrude from the inside walls of the cylinder toward the center of said cylinder and are orientated toward the outlet with a suitable angle. The orientated means can be constituted by solid or hollow needles or by a hollow truncated cone with a saw-toothed edge or other. Another variation is constituted by a cone- shaped tapering and saw-toothed internal profile. The locking means can optionally be arranged at right angles to the cord, so as to allow positioning of the cord and therefore so that they are activated appropriately in order to lock the cord in both directions. Flow is ensured by the appropriate choice of the dimensions of the locking means.

A coupling device 7 for hermetically coupling the central body and a collection container.

Said coupling device is constituted by a coupling system of the conical or screw or ring or other type between the central body and a collecting container constituted by a pouch, syringe, flask, collection tube or other. In the example shown in FIG. 5, the coupling device s an element 7 which has a conical coupling with the central body and can be connected to a collection pouch. Other systems can be adopted for the connection of other containers. A sealing device 8 for hermetically sealing the umbilical cord and the outer surface of the central body.

The function of the sealing device is to isolate from the outside environment the cut end portion of the umbilical cord, which is locked inside the central body. Said isolation is produced by virtue of sealing elements which adhere to the cord, optionally proximate to the point where the cord enters the central body, and thus ensure sterility inside the central body. This device also allows to contain any anticoagulants or other substances introduced in the central body. The device does not entail significant decreases in cross-section or capacity of the umbilical cord or flow resistances of any other kind. The sealing device 8 comprises a cylindrical or conical sheath made of elastic material (rubber, silicone, polymers or other material suitable for the purpose), which is shaped and sized so that the walls of one end adhere to a preset portion of the umbilical cord without compressing it but also ensure a hermetic seal, whilst the other end adheres to the outer surface of the central body or is coupled or mated to it by gluing, rings, conical coupling or other means. The sealing means, which are given appropriate dimensions and studied appropriately, can also ensure pressure tightness.

A cutting device 400 for cutting the umbilical cord. The connector assembly according to the invention can optionally comprise a cutting device for cutting the umbilical cord or vessel or tube. The cutting device 400 of FIGs. 6 and 7 comprises a metallic element 9 which has a sharp end, with a central slot whose size and shape are suitable for the flow of blood (and which optionally corresponds to the inside diameter of the central body) and one end, which is opposite to the sharp one and has a radiused surface 10 which is suitable to be pushed by the operator. Said metal element is located in the central body in suitable guides 11 which allow its sliding (guillotine). The metal element, after cutting the end portion of the umbilical cord or vessel or tube, ensures the outflow of the blood through the system by means of the slot provided in the body of said metal element. The cutting system can optionally be connected to the central body only temporarily and can be disconnected after cutting 12: in this case, it is a metal element such as the one described n the previous hypothetical case; however, the presence of the slot required for the flow of blood after cutting is optional.

A disinfection and cleaning device 500 for disinfecting and cleaning the umbilical cord. The disinfection and cleaning device, which can optionally be connected to the central body, is an element which is suitable to appropriately clean and disinfect the cord or vessel or tube practically, quickly, effectively and without risks for the operator. The device 500, shown m FIGs. 8 and 9, comprises a cylinder, which contains an element 13 which is made of elastic material which is optionally spongy and cylindrical and has a central hole 14, or of two half cylinders which are mutually coupled so as to obtain a cylinder and contain two half cylinders provided with a central longitudinal groove. Said central element, made of optionally spongy elastic material and having appropriate dimensions so as to allow the accommodation and sliding of the umbilical cord or vessel or tube, is impregnated with disinfectant, which makes contact with the outer surface of the cord or vessel or tube while passing through the cylinder. At one end, two elements made of elastic material and having appropriate dimensions 15 ensure clamping upstream of the disinfection area. FIGs. 10-12 schematically show the operational steps of the assembly according to the invention.

The description of the assembly given hereinafter is a non-limitative example of the invention and relates to its application to the withdrawal of placental blood from the umbilical cord during childbirth. The invention can of course be used to collect blood or other liquids drained from other vessels or tubes.

During childbirth, immediately after expulsion of the newborn child, the umbilical cord is closed in two points and then cut in a point which is intermediate between the two closure points. The end of the cord which is connected to the placenta remains available for coupling to the connector assembly.

First of all, it is necessary to accurately clean and disinfect the end portion of the umbilical cord which will be used for the collection procedures. This procedure can be performed with a swab impregnated with suitable disinfectant or by using the disinfection and cleaning system which is part of the invention: the cord is accommodated in the cleaning and disinfection element and, by sliding the element along the umbilical cord, the appropriate portion is disinfected and cleaned with an appropriate disinfectant as well as quickly and uniformly.

The connector assembly, which is sterilized beforehand, is in the illustrated configuration 31: the umbilical cord anchoring system passes through the central body. The operator must couple the anchoring system to the maternal end portion of the umbilical cord, sliding the sheath along the guiding element. Once the end portion of the cord has been anchored, the operator, by pulling the end that can be grasped, pulls the umbilical cord through the central body 32. When the umbilical cord is in the position deemed optimum, it is cut with the cutting system included in the invention or with a pair of scissors 32. When the umbilical cord is cut, the operator pulls the umbilical cord in reverse with respect to the entry direction; in this manner, the umbilical cord is fixed inside the central body by the needles or by other means or suitable locking elements. When the umbilical cord is locked, the operator can connect the central body to the collection container 33, optionally after removing the cutting system.

A variation of the cord connector assembly provides for the application of said system immediately after the expulsion of the neonate, before cutting the umbilical cord. The system, in this case, in order to be applied to the umbilical cord which is still joined to the child, is constituted so that it can be applied around the cord without requiring a cut and free end.

In the particular case of blood collection from the cut end portion of the umbilical cord, the system according to the invention combines the advantages of the systems currently used for this purpose and eliminates their shortcomings, since it is a closed system in which the umbilical cord portion, once disinfected and connected, is isolated from the outside; sterile collection, suitable for use for a transplant, is ensured because the risk of contamination of the collected blood with microorganisms present in the environment is eliminated and contamination with maternal blood, which usually abundantly flows along the outer surface of the cord, is also prevented; it does not produce resistances to the flow of blood and allows collection from all three vessels of the umbilical cord; since the umbilical cord, once it has been connected, is firmly placed in the central body of the system, no particular care in movements is required and optional expression is facilitated; it does not use needles or other exposed pointed objects and therefore the operators are not exposed to the risk of accidental punctures; the constant presence of an operator is not required; the system can be used by health operators, even non-medical ones, since it does not require particular experience or specific training.

As shown schematically in FIG. 13, the connector assembly according to the invention can be an integral part of a procedure which provides for the connection of the umbilical cord or vessel or tube to the collection container by means of the invention and for the subsequent application of pressure to the placenta by virtue of a suitable apparatus. The placenta is placed on a supporting membrane

20 so that its maternal surface is directed upward and its fetal surface is directed downward. The umbilical cord, which protrudes from the fetal surface of the placenta, is accommodated, in its initial portion, in a hollow cylindrical element of appropriate size 22, whilst the end portion, which has an appropriate length, is connected to a collection container by means of the invention. The maternal surface of the placenta is separated from a hermetic chamber 16 by means of a membrane made of elastic material: the pressure applied by the membrane in the inactive position or the pressure generated by a pneumatic, electric or other system inside the hermetic chamber is transmitted to the upper surface of the placenta by virtue of the elastic membrane 17. An appropriate mechanical pressure, generated by the rotary motion of a spiral conical element 26, is optionally applied to the fetal surface of the placenta. In the connector assembly according to the invention, the cut end portion of the umbilical cord or vessel or tube, optionally after disinfection, is inserted in the central body of the system, optionally by means of a guiding element, arranged as necessary, and locked by appropriate locking means without squeezing, compressing or choking or in any case compromising the capacity of said vessel; is isolated from the outside environment with appropriate sealing elements which adhere to said cord; and is finally connected to a collection container, thus allowing collection, in sterile conditions, of the blood or other fluid drained from the umbilical cord or vessel or tube.

The above described assembly is non- 1 imitative , exemplifies one of the possible embodiments of the invention and relates to its application to the collection of placental blood from the umbilical cord, but it can of course be used to collect blood or other fluids drained from one or more vessels or from a hollow tube which has a variable cross-section with soft and elastic walls which have a loose and easily collapsible consistency.

Claims

CLAIMS 1. A connector assembly for collecting fluids, characterized in that it comprises a central hollow body adapted to accommodate and lock the cut end portion of the umbilical cord or other vessel or tube; a coupling device for hermetically coupling said central body to a collection means; a sealing device for hermetically sealing said cord, vessel or tube and an outer surface of said central body.

2. The assembly according to claim 1, characterized in that it further comprises a cutting device for cutting said cord, vessel or tube.

3. The assembly according to claim 1, characterized in that it further comprises a disinfection and cleaning device for disinfecting and cleaning said cord, vessel or tube.

4. The assembly according to one or more of the preceding claims, characterized in that t comprises an anchoring device adapted to anchor the cut end portion of the umbilical cord or other vessel or tube and convey it through said central hollow body.

5. The assembly according to one or more of the preceding claims, characterized in that said central body is constituted by a cylindrical hollow body whose cross-section is suitable for the passage of said cord or vessel or tube, with an end for the entry of said cord or vessels or tube and with the opposite end for exit; said central body allowing the insertion of said cord through the entry end and optionally its exit from the opposite end.

6. The assembly according to one or more of the preceding claims, characterized in that said anchoring device comprises an end which protrudes from the inlet of the central body and is suitable to engage the cord or vessel or vessels or tube and an opposite end which protrudes from the exit of the system and can be gripped by the operator or an element which passes through the connector assembly and allows to engage the cord or vessel or vessels or tube, pull or guide the cord or vessel or vessels or tube through the system, position it appropriately, and can be easily disengaged from the umbilical cord or vessel or vessels or tube at the selected time.

7. The assembly according to one or more of the preceding claims, characterized in that said hollow element is obtained by coupling two parts to allow to open the connector assembly or to position said system around the umbilical cord or vessel or vessels or tube even before cutting the cord or when a free end of the umbilical cord or vessel or tube is not available.

8. The assembly according to one or more of the preceding claims, characterized in that said hollow body has, on its inside wall or inside it, elements or means for locking the umbilical cord or vessel or vessels or tube in at least one direction without squeezing, compressing or choking said umbilical cord or vessel or tube.

9. The assembly according to one or more of the preceding claims, characterized in that said hollow body has inner locking means arranged in a direction which allows the passage and positioning of the umbilical cord or vessel or tube and then locks it in at least one direction without squeezing, compressing or choking said umbilical cord or vessel or tube.

10. The assembly according to one or more of the preceding claims, characterized in that said locking means comprises pointed or sharp and rigid members which protrude from the inside wall, are directed toward the exit of the body and are inclined toward the central axis of the body so as to allow the umbilical cord or vessel or tube to pass in the direction from the inlet to the outlet and to lock it, by penetrating its walls, when the umbilical cord or vessel or tube is made to slide in the opposite direction.

11. The assembly according to one or more of the preceding claims, characterized in that said locking means are elastic so as to allow the umbilical cord or vessel or tube to pass but so as to lock it once the locking means has penetrated it.

12. The assembly according to one or more of the preceding claims, characterized in that said locking means allow movement of the umbilical cord or vessel or tube in a single direction.

13. The assembly according to one or more of the preceding claims, characterized in that said locking means are constituted by pointed or sharp elements, which in the inactive position do not prevent the passage of the umbilical cord or vessel or tube and, after activation, lock it in at least one direction inside the hollow body.

14. The assembly according to one or more of the preceding claims, characterized in that it further comprises separation means which form a closed space for the passage of the blood; the blood that flows out from the end of the umbilical cord or vessel or tube passes into the inner space of the connector assembly, which is delimited and formed by the internal surfaces of the central body, by the surfaces of the locking means, by the outer surface of the portion of the umbilical cord or vessel or tube which is contained inside the assembly and is locked inside the connector assembly by the means that protrude from the inner walls, the internal surfaces of the system for coupling the central body to the collection container, any internal surfaces of other useful elements, such as the duct that conveys anticoagulant, overpressure valves, etcetera.

15. The assembly according to one or more of the preceding claims, characterized in that said central body has, at the entry end, separation means which are suitable to isolate the inner part of the system from the outside environment when the umbilical cord or vessel or tube is positioned in the system and in the subsequent steps, thus ensuring sterility of the collection operation.

16. The assembly according to one or more of the preceding claims, characterized in that said separation means ensure a hermetic seal.

17. The assembly according to one or more of the preceding claims, characterized in that said separation means ensure pressure tightness.

18. The assembly according to one or more of the preceding claims, characterized m that said sealing means comprises elastic membranes, forming a seal with the central body and with the umbilical cord or vessel or tube, said membrane being sufficiently elastic to prevent any significant compression of the umbilical cord or vessel or tube whilst ensuring perfect adhesion and therefore a hermetic seal.

19. The assembly according to one or more of the preceding claims, characterized in that said sealing means comprises elastic elements made of foamed material.

20. The assembly according to one or more of the preceding claims, characterized in that said sealing means contain, or are impregnated with, a disinfectant substance which is released onto the outer surface of the portion of the umbilical cord or vessel or tube during its passage through the sealing means.

21. The assembly according to one or more of the preceding claims, characterized in that it comprises a valve means arranged at the exit end of the central body for allowing to temporarily halt the flow for optional separate collections or for particular collection procedures.

22. The assembly according to one or more of the preceding claims, characterized in that it comprises an element for disinfecting the cord at the exit end of the body of the system.

23. The assembly according to one or more of the preceding claims, characterized in that the central body has an access path for drawing amounts of blood or fluid during collection.

24. The assembly according to one or more of the preceding claims, characterized in that it can be applied during childbirth, directly after expulsion of the neonate and in any case even before expulsion of the placenta, in order to begin collecting blood or fluids as soon as possible or directly after expulsion of the neonate.

25. The assembly according to one or more of the preceding claims, characterized in that it remains in connected position or coupled to the cord before, during and after expulsion of the placenta and therefore does not require additional handling during blood collection.

26. The assembly according to one or more of the preceding claims, characterized in that it can be used with an apparatus suitable to apply pressure to the placenta without having to be repositioned on the vessel or in any case ithout requiring handling which can compromise sterility, yield or practicality and safety of the collection.

27. The assembly according to one or more of the preceding claims, characterized in that it is an integral part of a process for collecting blood or fluids from a placenta or organs or tissues which comprises an apparatus for applying to the placenta a positive pressure of an appropriate kind and intensity, such as to cause the outflow of the blood or fluid contained in the placenta or organ or tissue.

28. The assembly according to one or more of the preceding claims, characterized in that it is an integral part of a procedure which sequentially includes the connection of the umbilical cord or vessel or tube to the collection container by means of the connector assembly according to the invention and the subsequent application of pressure to the placenta by means of a suitable apparatus, ensuring a high yield of collection by means of a procedure which is practical and safe to use for the operator.

29. The assembly according to one or more of the preceding claims, characterized in that it s adapted to connect the end portion of the umbilical cord or of one or more vessels or of a hollow tube having a variable cross- section with soft and elastic walls, having a loose and easily collapsible consistency, to a system for collecting blood or fluid, characterized in that the cord or vessel or tube, is inserted in the system, optionally by means of a guiding element; is locked in the central body of the system by appropriate locking means without squeezing, compressing or choking or otherwise compromising the capacity of said vessel; is isolated from the outside environment with suitable sealing means; and is finally connected to a collection container, thus allowing collection of the blood or fluid drained from the cord or vessel or tube by means of a closed system, in a confined space, which ensures sterility.