FR2954085A1 - Umbilical cord receiving device for sampling hematopoietic stem cell e.g. after expulsion of newborn, has gripping element extended from connecting part of body, arranged opposite to proximal end of receiving part and held in hand - Google Patents

Abstract

The device (1) has a body (2) comprising a receiving part (3) on which an umbilical cord is received, where the receiving part comprises a proximal end and a distal end. The body includes a connecting part (8) in extension of the proximal end of the receiving part, where the connecting part comprises an umbilical cord compression element (9) i.e. clamp, or umbilical cord compression element association units (10). A gripping element (11) i.e. rigid tongue, is extended from the connecting part, arranged opposite to the proximal end of the receiving part and arranged to be held in a hand.

Description

The invention relates to a device for receiving an umbilical cord for placental blood sampling.

The invention typically applies to the collection of placental blood which is a source of different types of stem cells, and in particular hematopoietic stem cells (HSCs). These HSCs are capable of reconstituting the hematopoietic system, at the origin of the manufacture of cells participating in the defense of the body, in its entirety. They are at the heart of new cell therapies, especially in the form of transplant to patients with congenital or acquired hematological diseases such as cancer or leukemia.

In addition, cord blood stem cells have the particularity to multiply rapidly and lead to a lower risk of rejection, because of their immature nature. They are therefore very coveted. There are two techniques for collecting placental blood: before delivery of the placenta (in utero) and after delivery of the placenta (ex utero).

To implement these techniques, there are medical devices in the form of a bag system such as those described in EP-1 262 202. These bag systems comprise collection bags and one or two puncture needles.

In practice, after expulsion of the newborn, the umbilical cord is clamped in two separate places and close to the newborn. The cord is then cut between the two clamps to separate the newborn from the mother. An umbilical cord puncture not associated with the neonate is then performed near the clamp attached to the cord with a needle connected to a blood collection bag. This operation is a dangerous technical gesture which entails a significant risk of stinging for the person performing it.

WO-01/76660 discloses a gutter-shaped device for receiving the cord by protecting the hand that supports the cord.

Similarly, the document FR-2 609 635 describes a gutter equipped with two clamps at each of these ends, one rigid to block the blood circulation and allow the puncture of the umbilical cord and the other flexible to hold the cord in place .

WO-98/08433 describes a similar device provided in addition to notches on the side of the device for holding the needle used to perform the puncture.

These different devices prevent the placental blood sampler from being stung by the needle which would cross the umbilical cord during the puncture. However, there remains the risk that the needle slides on the cord and comes prick the fingers of the sampler who holds such gutter devices in his hand. In addition, these devices are relatively bulky, which does not facilitate their handling.

The invention proposes to secure the puncture of the umbilical cord by providing a cord device which is held by the sampler away from the puncture site of the umbilical cord. In addition, the device is compact, easy to use and allows convenient access to the umbilical vein.

For this purpose, the invention provides a device for receiving an umbilical cord comprising a body having a receiving portion on which the umbilical cord is intended to be received, said portion having a proximal end and a distal end, said body having further a connecting portion in the extension of the proximal end of said receiving portion, said connecting portion carrying a compression member of said umbilical cord or means for associating such a compression member, the device comprising furthermore, a gripping member extending from said connecting portion and away from the proximal end of the receiving portion, the gripping member being arranged to be held in one hand.

The invention will be understood from the following description. Figure 1 shows a schematic perspective view of the device of the invention according to one embodiment.

Figure 2 shows a schematic and perspective view of the device of the invention according to another embodiment.

FIG. 3 represents a schematic and perspective view of the compression element of the device of FIG. 1 or 2.

FIG. 4 shows a schematic side view of the compression element of FIG. 3.

FIG. 5 represents a schematic and perspective view of the device of FIG. 2, without compression element.

FIG. 6 represents a schematic view from below and in perspective of the device of FIG. 1.

FIG. 7 represents a schematic side view of the device of FIG. 5.

FIG. 8 represents a schematic bottom view of the device of FIG. 2.

To collect blood from an umbilical cord or placental blood, after expulsion of the newborn, the cord is first cut between two compression members such as clamps, to separate the newborn from the mother. Then, a puncture is performed using a sampling needle connected to a bag system, on the portion of the cord still connected to the placenta. For this, the person taking the sample holds the cord in one of his hands and 5 comes to stitch the vein of the umbilical cord near the clamp with a needle held in his other hand.

The invention proposes a device 1 intended to receive an umbilical cord, and in particular the portion of the umbilical cord on which the puncture of the placental blood will be performed.

As illustrated in Figure 1, the device 1 comprises a body 2 having a receiving portion 3 on which is intended to receive the umbilical cord, said portion 3 having a proximal end and a distal end.

The terms "distal" and "proximal" are defined relative to the person when using the device at the time of placental blood sampling. The terms "high" and "low" are defined relative to the device in its position of use.

In particular, the receiving portion 3 comprises a groove 4 in which the cord is received. The throat is for example U-shaped more or less flared which follows the circular shape of the umbilical cord. This particular shape 20 keeps the cord in place and forms a wedging zone.

In Figures 2, 5 and 8, the groove 4 comprises on each side a side wall 5 from which extends a peripheral skirt 6. In addition, an open space 7 is formed under the groove 4 between said side wall and said peripheral skirt. This space gives the possibility to the sampler to slide the fingers of a hand, for example the thumb and forefinger to maintain the device, for example during the puncture. The peripheral skirt 6 then protects the fingers of the sampler from the risk of stinging.

To position the cord on the device 1, the sampler is free to hold the device by the peripheral skirts 6. The straight shape of the skirts makes it easier to hold the device than when the receiving part is curved and in the absence of peripheral skirt.

The receiving portion 3 is wide enough to receive the cord in its width. The length of the receiving part is for example of the order of a few centimeters, in particular of about 3 cm. This length is sufficient to easily access the vein of the umbilical cord which must be stitched to perform the puncture.

The length of the receiving part 3 is also sufficiently short so as not to risk breaking the device during the puncture, by pressing too heavily on the receiving part, for example.

In addition, the relatively small size of the device facilitates its handling.

Alternatively not shown, the receiving portion is curved downwardly so as to bend the cord and make the umbilical vein more accessible.

According to the figures, the body 2 of the device further has a connecting portion 8 in the extension of the proximal end of the receiving portion 3. The connecting portion 8 carries a compression element 9 of the umbilical cord, such as a clamp, and / or associating means 10 of such a compression element 9. When the compression element 9 is not associated with the rest of the device, it is for example used as a conventional clamp. In particular, it is used to clamp the umbilical cord near the neonate, before cutting the cord. Once the cord is cut, the sampler mounts this compression member over the rest of the device and conducts the placental blood puncture safely as explained below.

In another example of use, once the puncture is performed, the body 2 is dissociated from the compression element 9, and used as a means of protection of the hand to perform another puncture elsewhere in the cord.

In connection with FIG. 1, the device 1 of the invention further comprises a gripping element 11 extending from the connecting part 8 and opposite the proximal end of the receiving part 3, the gripping element 11 being arranged to be held in a hand without contact with the receiving part 3.

The gripping element 11 is in the form of a rigid tongue. It is held between the thumb and the other four fingers of the hand.

In another embodiment, the tongue is held between the thumb and two fingers of the hand.

In particular, the tongue has a length of about 10 cm, sufficient to be firmly gripped in one hand and short enough to handle the device without interference.

In particular and as shown in the figures, the body 2 and the gripping element 11 are formed in one piece, for example by injection molded in a thermoplastic material. The thermoplastic material is in particular polyamide, polyacetal or polyoxymethylene.

To make a placental blood sample, the cord is placed in the receiving portion 3 and in the compression member 9, for example, so that the free end of the cord, i.e., the end which has been cut to separate the newborn from the mother, is disposed proximally, that is to say on the side of the gripping element 11.

The umbilical cord is compressed with the aid of the compression element 9 to stop the flow of blood into the cord.

In order to perform the puncture, the sampler holds the device 1 in one hand with the aid of the gripping element 11 serving as a handle and, with its second hand, pricks the vein of the umbilical cord with a needle.

As the gripping element 11 is remote from the receiving portion 3, the risk of puncture is almost zero.

When handling the device 1, the receiving part 3 of the cord is advantageously placed horizontally, so as to facilitate access to the umbilical vein.

In this position, the gripping element 11 extends downwardly relative to the receiving portion 3 of the device. The gripping member 11 extends proximally, in particular by being inclined to form an angle of about 45 ° to the vertical. This particular position ensures a good maintenance of the device. According to FIG. 2, the connecting portion 8 has a zone 12 that is horizontal and parallel to the receiving portion 3 and an inclined zone 13 connecting the receiving portion 3 and said parallel zone 12.

In particular, the inclination of the inclined zone 13 corresponds to the inclination of the gripping element 11, so that the surface of the device substantially forms a staircase with two steps, the highest step forming the receiving portion 3, and the lowest step the horizontal zone 12 of the connecting part 11. According to FIGS. 1 and 2, the compression element 9 is disposed on the horizontal zone 12, so that the umbilical cord passes through said element compression 9.

In this way, the compression element 9 is at the same level as the bottom of the receiving part 3. Thus, the cord, once in place on the device, is straight.

According to FIG. 3, the compression element 9 comprises a first and a second part 14, 15 between which the bead is intended to be positioned, said parts being rotatably mounted relative to one another between a position open and a closed position and said parts comprising reciprocal locking means of the closed position.

The parts 14, 15, for example in the form of a narrow and long bar, are rotated relative to each other by means of a hinge 16.

The hinge 16 is in the form of a hollow cylinder portion connecting the ends of the two parts 14,15. The inside of the cylinder is provided with a strip 33 (FIGS. 3 and 4) which prevents the cord from coming inside the joint and thus ensures that the cord is totally compressed, when the element is closed. compression 9.

The reciprocal locking means are for example snap-fastening means.

In particular, each of the opposite ends of the two parts are provided with a locking element which cooperates with the other by engagement when the two parts are brought together.

According to Figure 1, the upper part 14 is provided with a hook 17. The other part 15 is provided with a groove 18 adapted to receive the hook 17.

According to a first variant embodiment, the compression element 9, once closed, can be opened again. This variant is suitable in the case where, for example, the sampler wishes to change the position of the clamp on the cord, following a bad initial positioning and / or to perform another puncture at another location of the cord. In this variant, the locking means must be reversible, that is to say able to be unlocked. If snap-in means are used, a way of easily disengaging the locking elements is to make the hinge 16 of the compression element 9 sufficiently flexible so that the parts 14, 15 can be laterally displaceable so that disengaging the locking elements.

In a second variant, the locking means are irreversible, that is to say, once engaged, the compression element can not be opened again, in particular by the only manual force and without tools.

For example, if snap-in means are used and unlike the first variant, the locking elements can not be unlocked by lateral sliding.

In connection with FIGS. 3 and 4, the locking means are arranged to maintain the first and second parts 14, 15 in a pre-closed position intermediate between the open and closed position.

To do this, a second groove 19 is disposed above the first groove 18. When the piece provided with the hook pivots towards the part provided with the two grooves, the hook 17 engages first in the groove of the top 19 , defining a pre-closed position. In this position, the compression element 9 is closed, but there remains a space between the two parts. Advantageously, this gap is sufficiently small to block the blood circulation of the cord disposed within the compression member between the two pieces.

When additional pressure is exerted, the hook 17 then engages in the groove 18 the lowest, defining the closed position. In this position, the space between the two parts is reduced with respect to the pre-closed position, up to, for example, zero.

The pre-closed position of the compression element is reversible, that is to say that the hook 17 and the highest groove 19 form reversible locking means. The pieces 14, 15 can slide sideways on one side to disengage the hook from the groove.

On the contrary, the closed position of the compression element 9 is irreversible, that is to say that the hook 17 and the lowest groove 18 form irreversible locking means. The lateral sliding of the parts is prevented by a side wall 20 at the level of the lowest groove.

In this embodiment, the sampler is free to choose the position of the compression element 9 of its choice from the irreversible reversible or closed pre-closed position.

The parts 14,15 further comprise an inner toothed surface 21 in contact with the cord to prevent slippage of the bead.

Moreover, the outer surface of one of the parts 14 is provided with ridges 22 to improve the adhesion of the fingers of the sampler and to prevent the accidental slipping of the fingers of the sampler during the closure of the compression element.

In a particular embodiment, the compression element 9 further comprises a projection 23 provided with a notch 24 for containing a needle or a portion of tubing.

In the figures, each of the parts 14, 15 of the compression element 9 is in the form of a long and narrow bar. In this case, the compression element 9 is associated horizontally in the lengthwise direction on the connecting element, perpendicularly to the bead.

The notch 24 of the compression element 9 is disposed on the upper part 14 in the axis of the umbilical cord when it is on the device. In combination with the step form of the device, the particular situation of the notch 24, allows to install the needle parallel to the cord, which is the optimal position for the removal of placental blood. In addition, the needle pierces the cord just behind the compression member 9 to recover as much placental blood as possible. In addition, the needle, once disposed in the notch 24, remains in place without being maintained. Thus, the sampler has the opportunity to use both hands to, for example, massage the cord to recover the maximum of placental blood. In an embodiment not shown, the body of the device 2 and the compression element 9 are formed in one piece.

In the embodiments of the figures, the body 2 and the compression element 9 are separate and assembled either at the time of manufacture or at the time of use.

For assembly and as shown in FIGS. 5 to 7, the horizontal zone 12 of the connecting portion 8 and the compression element 9 comprise complementary association means which cooperate to associate the compression element with the device. .

In particular, the complementary association means are snap engagement means. In particular, the compression element 9 is provided on one of the parts 15 of at least one hook 25 forming a projection. For example, the compression element comprises two hooks on one of the parts of the compression element.

In a complementary manner, the connecting element is provided with at least one opening 26 (FIGS. 6 and 8), for example two openings, in which the hooks 25 of the compression element 9 engage.

In the embodiment shown, the association means are symmetrical, that is to say that the compression element is mounted indifferently with the articulation on one side or the other of the device.

These means of association are reversible or irreversible. When reversible, the compression member may be disengaged from the link element. This embodiment allows, for example, once the bead compressed by the compression element and the puncture performed, dissociate the compression element 9 from the rest of the body 2 and use the body alone as a hand protector to achieve another puncture.

In Figures 3 and 4, a stop is arranged on the compression element 9, between the two hooks 25, so as to drive the compression element 9 in the openings 26 to the position allowing the engagement of the hooks in the openings.

In addition, the connecting element 8 is provided with two tabs 28 parallel to each other intended to be assembled on indentations 29 made on the compression element 9. This arrangement makes it possible to hold the compression element 9 securely on the body 2 of the device. In FIGS. 2 and 5, the body 2 is furthermore provided at its distal end with a holding element 30 for the cord on the receiving part 3. In particular, the holding element is in the form of a lanyard. adjustable by means of a plurality of apertures 31. Each aperture may engage a protrusion 32 disposed at the distal end of the receiving portion of the device.

This strap is used to fix the cord in the receiving part, regardless of its size. Thus, the cord does not slip when it is stung by the needle and the sampler does not need to hold it manually. 10 25 30

Claims (12)

REVENDICATIONS1. Device (1) for receiving an umbilical cord comprising a body (2) having a receiving portion (3) on which the umbilical cord is intended to be received, said portion (3) having a proximal end and a distal end, said body (2) further having a connecting portion (8) in the extension of the proximal end of said receiving portion (3), said connecting portion (8) carrying a compression member (9) of said umbilical cord or means for associating (10) such a compression element, characterized in that it further comprises a gripping element (11) extending from said connecting portion (8) and opposite the proximal end of the receiving portion (3), the gripping member (11) being arranged to be held in one hand. 2. Device according to claim 1, characterized in that the gripping element (11) extends downwardly relative to the receiving portion (3). Device according to claim 1 or 2, characterized in that the connecting part (8) has a horizontal zone (12) parallel to the receiving part and an inclined zone (13) connecting the receiving part (3). and said parallel area (12). 4. Device according to claim 3, characterized in that the compression element (9) or the association means (10) are arranged on the zone (12) 25 horizontal. 5. Device according to any one of claims 1 to 4, characterized in that the receiving portion (3) comprises a groove (4) in which the cord is intended to be received. 6. Device according to claim 5, characterized in that the groove (4) comprises on each side a side wall (5) from which extends a peripheral skirt (6). 15 7. Device according to any one of claims 1 to 6 characterized in that the compression element (9) comprises a first and a second part (14,15) between which the bead is intended to be placed, said parts being mounted in rotation relative to each other between an open position s and a closed position and said parts comprising interlocking means (17,18) of the closed position. 8. Device according to claim 7, characterized in that the locking means (17,19) are further arranged to maintain the first and second parts (14,15) in a pre-closed position intermediate between the open position and closed. 9. Device according to any one of claims 1 to 8, characterized in that the body (2) and the compression element (9) are formed in one piece. 10. Device according to any one of claims 1 to 9, characterized in that the compression element (9) comprises a projection (23) provided with a notch (24) for containing a needle or a portion of tubing . 20 11. Device according to any one of claims 1 to 10, characterized in that the body (2) is further provided at its distal end of a member (30) for holding the cord on the receiving portion (3). . 12. Device according to claim 11, characterized in that the holding element is in the form of an adjustable strap.