WO1998032475A1

WO1998032475A1 - Apparatus for collecting fluids

Info

Publication number: WO1998032475A1
Application number: PCT/EP1998/000370
Authority: WO
Inventors: Valter Paderni
Original assignee: Crb Nederland B.V.
Priority date: 1997-01-28
Filing date: 1998-01-23
Publication date: 1998-07-30
Also published as: IT1290716B1; ITUD970015A1; AU6615598A

Abstract

An apparatus for collecting blood from a placenta or from other human or animal organs, comprising a support having supporting stems (13) which are substantially parallel to the orientation of the surface vessels and thus do not hinder blood drainage and by the presence of an opening (12) for easily positioning the placenta or organ and the umbilical cord or vascular bundle, respectively, which are possibly already connected to a collection system.

Description

APPARATUS FOR COLLECTING FLUIDS Technical Field

The present invention relates to an apparatus for collecting fluids, particularly a support system for optimizing the collection of blood or other fluids from a placenta or from other human or animal organs or tissues <by using the force of gravity (i.e., gravity collection).

The system according to the present invention is used predominantly in the biological, medical and veterinary field for diagnostic and therapeutic purposes and for research purposes in order to collect blood or other fluids from the placenta or from another organ or tissue to be used subsequently as a source of cells, molecules or other. Background Art

In the biological, medical and veterinary fields it is necessary to collect fluids, particularly blood, from organs or tissues or from containers in general 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 processing; 2) the collection of blood from the placenta during childbirth, directly after cutting the umbilical cord. In this second case, the blood is useful because it contains stem cells, which are he atopoietic progenitor cells, i.e., cells capable of reconstituting the hematopoietic system and therefore usable, if the need arises, for transplanting back into the donor or into 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 non-limitative and is merely an example of situations requiring collection of blood or other fluid from tissues, organs or other containers in general.

Placental blood from the umbilical cord is collected since 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 possibility of contamination of the collected blood, which is fetal in origin, by foreign cell populations, such as for example maternal cells, must be minimized; 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 birth, 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 that 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 in a net 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 performed in this way, since the efferent vessels located on the outer surface of the placenta are compressed by the structure of the net, preventing their unhindered emptying. Moreover, this procedure exposes both the operator and the environment to contamination with blood and other potentially infected material.

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 mouth 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 that are present in 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 has in fact a loose consistency, and since it is simply rested on the mouth of the collection container it can easily escape from it, consequently contaminating said end portion in addition to losing blood, which contaminates the outside environment.

Moreover, the system inherently (being an "open" system) collects both the blood that flows out of the cord vessels and the potentially contaminated liquids that flow along the outer surface of the umbilical cord; in particular, maternal blood, which is abundantly present on the outer surface of the placenta, flows along the cord and mixes with the blood of the umbilical cord.

This collection system also 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 exclusively 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 operators to the risk of accidental punctures.

Moreover, the needle inserted in the umbilical vein is not stably fixed to said vein and can easily come loose. also in view of the highly dynamic nature of childbirth; this problem is particularly felt if collection is continued also 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; moreover, repetition of venipuncture is 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. Blood flow is also 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 that remains downstream of the insertion point is not recovered. Disclosure of the Invention

The aim of the present invention is to overcome the drawbacks of the cited prior art.

A particular aim of the present invention is to optimize the extraction of fluids, particularly blood, from the placenta or from another human or animal organ or tissue, both for diagnostic and therapeutic purposes and for research purposes, by using a support whose shape is suitable to support the placenta, organ or tissue without compressing the vessels for the outflow of the blood or other fluid, as expressed in the accompanying claim. The system described hereinafter and illustrated in the figures is non-imitative and merely exemplifies one of the possible embodiments of the invention.

The above aims are achieved by an apparatus as claimed in the appended claims.

Brief Description of the Drawings Further characteristics and advantages of the invention will become apparent from the following description, illustrated by way of example, in the enclosed drawings, wherein:

Figure 1 is a top view of the apparatus according to the present invention;

Figure 2 is a front section view of the apparatus, according to line II-II of Fig. 1;

Figure 3 is a top view of the support, with the placenta in position, illustrating the path of the vessels and the orientation of the supporting stems;

Figure 4 is a sectional side view of the support, according to line IV-IV of Fig. 3, with the placenta in position;

Figure 5 is an enlarged-scale view of a detail of the support with the placenta in position;

Figure 6 is a side view of the stem;

Figure 7 is a schematic view of the system for connecting the umbilical cord;

Figure 8 is a schematic view of a placenta container, coupled hermetically to the connection system;

Figure 9 is a schematic view of the apparatus for applying pressure to the placenta, which comprises the placenta container and the umbilical cord coupling system connected hermetically to the collection container;

Figure 10 is a view similar to that of Fig. 6, showing a second embodiment of the stem. Ways of carrying out the Invention

The description of the system given hereinafter by way of non-limitative example relates to the application for extraction of blood from the placenta through the umbilical cord after expulsion of said placenta. The system according to the present invention can of course also be used to collect blood or other fluids from other organs or tissues.

The present invention can be divided into three components.

An upper part, suitable to support the placenta without constituting a hindrance to the outflow of the liquids contained therein through the umbilical vessels.

The upper part of the exemplifying and non-limitative system described here (figure 1) is constituted by a frame

11 made of suitable material, which is generally circular and is provided with an opening 12, and by a plurality of stems 13 which have a suitable length and cross-section, originate from the frame and are directed towards the center. The radial arrangement, from the frame towards the center, of the stems, which are therefore generally parallel to the orientation of the placental vessels

(figures 3, 5), reduces the probability of compression of the vessels and therefore of hindrance to the outflow of blood. The stems have an appropriate shape and elasticity. Figures 6 and 10 respectively illustrate two different exemplifying and non-limitative embodiments of a stem. Three regions can be identified: a lateral end 17,17a for connection to the frame; a central portion 18,18a, where the fetal surface of the placenta 28 rests, and shaped optimally to follow the profile of the placenta (figures 4, 5); a medial end 19,19a. The medial ends of the stems form, at the center of the frame, an appropriate space which is suitable to accommodate the umbilical cord (figures 4, 5). The central portion of the stem can be straight (figure 6) or can have such a shape as to further decrease the number of points of contact between the placenta and the support and therefore the probability of compressing the surface vessels, as shown, for example, in figure 10. The stems can be mutually separate, as shown in the illustrations, or connected to each other (embodiments not shown). A possible different embodiment which is not shown is constituted by a funnel-shaped element provided with stems which rest on the surface or are part thereof (ridges) and have a suitable size, shape and elasticity.

A lower component 14 is provided as a footing and optionally as a resting element for the container for collecting blood or other fluid. One or more components 15 are adapted to support the frame and provide vertical separation from the footing. These components, which have a suitable shape and cross- section, may optionally be adjustable in terms of length so as to adapt, in each instance, to the length of the umbilical cord. The support described so far can be an integral part of a system for extracting blood or fluids from the placenta or from organs or tissues which also comprises a system for coupling the umbilical cord to the collection container (figure 7). The system 23 for coupling the umbilical cord 20 to the collection container 26, shown in an exemplifying and non-limitative embodiment in figure 7, allows to isolate in an enclosed space 32 the end portion of the cut umbilical cord 20a and comprises sealing means 25, means for securing the cord 24, means 27 for coupling to a collection container 26 and an optional access pathway 31 for applying pressure or for introducing anticoagulant fluid or other fluid or to perform partial withdrawals of blood. The coupling system also comprises means 21 for disinfecting the end segment of the umbilical cord and means 22 for cutting it.

A container 29 for the placenta 28 and the umbilical cord is shown in an exemplifying and non-limitative embodiment in figure 8 and may include a hermetic connection to the coupling system 23.

An apparatus 30 for applying pressure to the placenta 28 is schematically shown in an exemplifying and non- limitative embodiment in figure 9, and may include the container for the placenta 29 and the system for coupling the umbilical cord 23 connected hermetically to the collection container 26.

The invention described so far and shown schematically in figures 1 and 2 is used as a support for draining blood from the placenta or organ or tissue when it becomes available, i.e., in the case of the placenta, after expulsion. The placenta can optionally be contained in a suitable container 29 having soft walls, with an optionally absorbent internal surface and an impermeable external surface, such as to not hinder drainage and have a protective and containment function respectively. The placenta is placed on the upper part of the support so that the maternal surface, hereinafter termed upper surface, is directed upward and the fetal surface, hereinafter termed lower surface, is directed downward (figure 4). The umbilical cord, which originates from the lower surface of the placenta, is accommodated, in its initial segment, at the center of the frame 11 in the space formed by the medial ends of the stems 19, while the end segment, having an appropriate length, is optionally already coupled or is subsequently coupled to a collection system. In the ideal configuration, the end segment of the umbilical cord is connected to a collection container 26 by means of a closed-circuit coupling system 23 which does not compress or in any case does not compromise the flow of blood while keeping all the vessels in the umbilical cord open. In this configuration, i.e., with the placenta placed on the upper part of the support (figures 3, 4) and the cord already connected to the collection container, the blood can flow freely out of the placenta into the container, since the supporting stems are orientated radially (figure 1) and therefore substantially parallel to the orientation of the vessels (figure 3).

The invention can be used, as described above, for gravity collection or can be adapted conveniently for use in a system which generates a suitable force (for example a centrifugal force).

The invention described so far can be an integral part of a system for extracting blood or fluids from the placenta or organs or tissues as follows: after expulsion of the newborn child, the umbilical cord 20 is cleaned and disinfected 21, cut 22 and coupled by means of an appropriate coupling system 23 which comprises suitable securing means 24 and means 25 for isolating from the outside the cut end segment of the cord 20a. The coupling system can be connected, or is already connected, to a collection container 26 by virtue of suitable hermetic means 27. A first collection of blood, prior to expulsion of the placenta, can thus be performed. During expulsion of the placenta, the cord remains connected to the coupling system and to the collection container, since the cord is firmly fixed and isolated from the outside by means of suitable securing means 24 and sealing means 25. After expulsion, the placenta 28 is inserted in a suitable soft container 29 provided with suitable hermetic closure means; said container can be an integral part of the coupling system and can be for example rolled up and packed on the outer edges of the coupling system and activated when required by unrolling along the umbilical cord and then around the placenta to be finally closed at the apex of said placenta. At this point, the placenta possibly contained in the container and positioned in the support according to the present invention (figures 2, 3, 4) is subjected to appropriate pressure, such as to facilitate the flow of blood from the placenta to the collection container through the umbilical cord and the coupling system. The pressure can be equal to the gravitational pressure, i.e., equal to one, and therefore collection occurs by gravity. As an alternative, the placenta 28 can be subjected to a higher-than-gravitational pressure with suitable means. Pressure can be applied for example only to the placenta by directly applying pressure to said placenta arranged on the support, which is suitably modified in order to include suitable means 30 for applying pressure. As an alternative, pressure can be applied to the entire support-placenta system; for example, by centrifuging the placenta already arranged on the support according to the present invention (an embodiment which is not illustrated). In this last case, the support is modified appropriately in order to withstand centrifuging and can include one or more systems for coupling the umbilical cord and blood collection containers which are suitable for centrifugal collection. If necessary, in order to optionally further improve collection or eliminate any clots in the umbilical vessels, it is possible to apply suction to the open end segment of the umbilical cord by means of an access pathway provided in the coupling system or in the collection container 31. By means of the sealing elements provided in the coupling system, which isolate the enclosed space 32 in which the cut end segment of the umbilical cord is located from the space that contains the placenta, it is also possible to apply the pressure directly inside the hermetic container 29 of the placenta by means of an appropriate access pathway 33.

The described procedure allows, with simple and safe operations, to maximize yield through sequential collection before and after expulsion of the placenta. The procedure also provides for the coupling of the cord to a system which allows to keep pervious all three vessels present in the umbilical cord, which can contribute to the maximum yield of the collection. The operation provides for containment, from the very start, of the placenta and of the cord without using exposed pointed or sharp objects, ensuring the best safety of the operator. In the procedure, all the steps of collection are performed in a closed system in which the blood does not make contact with the outside, thus preventing contamination of the sample.

The described system provides for use on the part of health operators, including non-medical personnel, since it does not require particular experience or training. It is also studied so as to make its use safe and free from critical points and from the risk of error. A normally- experienced health operator is capable of performing the entire procedure without risk while ensuring an optimum yield which is repeatable over time. The system also limits the contamination of the environment with blood and other potentially infected material.

Claims

1. An apparatus for collecting fluids comprising a supporting structure adapted to support an organ or tissue, such as a placenta, from which a fluid, such as blood, has to be extracted, characterized in that said supporting structure comprises a frame (11) and a plurality of stems (13) originating from said frame and directed towards the center of said frame to form a supporting surface means for said organ.

2. An apparatus according to claim 1, characterized in that the stems (13) are orientated radially or conveniently or parallel to the orientation of the surface vessels of said organ.

3. An apparatus according to claim 1, characterized in that the frame (11) from which the stems extend has an opening which allows easy positioning of said organ and of any vascular structures originating therefrom, also if they are already connected to a collection system.

4. An apparatus according to claim 1, characterized in that the frame (11) can be separated vertically from a footing by means of one or more elements.

5. An apparatus according to claim 1, characterized in that the frame can be suspended by virtue of suitable means.

6. An apparatus according to one or more of the preceding claims, characterized in that it is suitable to apply pressure to a placenta.

7. An apparatus according to one or more of the preceding claims, characterized in that it is suitable to apply pressure to the support-placenta system for example by centrifuging.

8. An apparatus according to claim 1, characterized in that said organ is confined in a partially or fully hermetic container of appropriate shape, optionally having an absorbent internal surface and an impermeable external surface, which allows to prevent the outer surface of the placenta or organ or tissue that is potentially contaminated from making direct contact with components of the apparatus and in any case isolates the placenta or organ or tissue from the outside environment.

9. An apparatus according to one or more of the preceding claims, characterized in that it is an integral part of a standardized system for collecting blood or fluids from a placenta or from organs or tissues which comprises the coupling of the umbilical cord to a collection container by means of a coupling system suitable to form a closed system for transferring said blood or fluids which prevents contamination of the collected blood and is easy and safe to use.

10. An apparatus according to one or more of the preceding claims, characterized in that it is an integral part of a procedure which entails coupling the umbilical cord or vessel to the collection container by means of a coupling system and subsequently arranging of the placenta in said apparatus and then applying pressure to the placenta by means of the system according to the present invention.