BE1029476B1 - Sterilizable tubing for a blood bag set or the like and a closing mechanism therefor, as well as a blood bag set equipped therewith - Google Patents

Abstract

Sterilizable flexible hose (3) made of a softened elastic PVC material as used in a blood bag set, which hose is provided with a closing section for local closure by moving opposite wall parts (7) of the hose (7) towards each other at that location. 3) by clamping or folding the hose (3) locally, characterized in that the hose (3) is provided with an anti-adhesive agent (6) at least locally at the location of the sealing part (6) during the sterilization of the hose (3) in closed condition, to prevent the wall parts (7) of the hose (3) that have moved towards each other at the location of the clamped or folded closing section from permanently sticking together or merging into each other and to prevent them from sticking together .

Description

Sterilizable tubing for a blood bag set or the like and a closing mechanism therefor, as well as a biomedical bag set equipped therewith.

The present invention relates to a sterilizable flexible hose as used in a blood bag set. A biced bag set is a system of one or more blood bags and other components such as, for example, a collection needle, in which the binding bags are mutually connected by means of siangen and in which one blood bag is connected to the collection needle by means of a hose.

After the Dlocc collection, in which the blood is collected in one blood bag, called the donor blood bag, the blood bag set with blood is centrifuged to separate the blood into different layers, more specifically into a layer of red blood cells, white biced cells and blood platelets, and plasma and are transferred one after the other to separate = blood bags, called satellite biobags, through the aforementioned tubing. The hoses of the blood bag set are flexible and are usually made of a softened elastic PVC material. The blood bags may contain a liquid which must not move freely from one blood bag or tubing to another. Therefore, sealing mechanisms are provided at certain points in the set to allow control of the passage of liquids.

Simply clamping the tubing to prevent the passage of liquids, for example with a so-called Roberts clamp or a sliding clamp, is effective in normal use of an already sterilized blood bag. However, such clamping cannot be used: on the soft PVC tubing as used in a blood bag kit in case the kit still needs to be sterilized. Such clogging of PVC tubing during steam sterilization usually results in the walls of the tubing material sticking or fusing due to the heat of the sterilizing steam, resulting in a tubing that is difficult to impossible to reopen. with one or more frangible connectors, which are generally referred to as a frangible connector, a breakaway connector or a frangible cannula connector, as in EP2777754A1.

Such connectors are hard plastic pieces on the inside of the tubing, which connectors are intended to prevent undesired displacement of fluids and/or biomes between the blood bags and/or between a blood bag and the collection needle.

At the appropriate time, the connectors can be broken or deformed, either manually or automatically, in such a way that the fluids and/or blood can travel through the tubing to an appropriate satellite bag.

The frangible connectors are typically opened manually by a back and forth motion, breaking the connector serst in one direction, followed by a break in the opposite direction.

From an ergonomic perspective, in particular “repetitive strain injury”, this is disadvantageous as bicedbanx operators have to process large quantities of blood bag sets on a daily basis, where each blood bag set may contain several fragile connectors. More recent semi-automatic component separators have integrated mechanisms that mimic the manual reciprocating movement, as in US29152756 and EPZ777754A1. A disadvantage of conventional breakable connectors is that they cannot be closed again after breaking or deformation and therefore a different a sealing mechanism is needed that then allows the pipes to be closed again, this sealing mechanism is usually a sliding clamp or the aforementioned Roberts clamp. Another disadvantage of the broken connector is that the sharp edges and/or constrictions in the flow profile can lead to negative effects on the bived components. Red cells can be directly damaged and/or undergo haemolysis and the shear stress created when bioeg components are pushed through can lead to platelet activation, which can have a negative effect on the quality and in vivo recovery of the blood cells. platelets, These possible negative effects are normally rather limited with a perfectly opened fragile connector, but can be very pronounced when the connector is not perfectly opened. This happens routinely and often goes unnoticed, contributing to a reduced quality of the blood components to be transfused.

Another disadvantage is the purity of the obtained blood components, when the layers separated after centrifugation are pressed through the breakable connector {as for example in fully automatic blood component preparers as described in patent US S,070,565 BZ, where this breakable connector is “breakable stopper 9” is mentioned). Due to the turbulence, especially when the buffy coat layer (the layer consisting of the platelets and a major part of the white blood cells) is pushed through the fragile connector, mixing can occur between the initially relatively well-separated layers of platelets and white blood cells (or between plasma and platelets or between white and red biced cells) which has a negative effect on the purity and/cE on the recovery of the desired bised components. The present invention aims to provide a solution to at least one of the aforementioned disadvantages and other disadvantages,

To this end, the object of the invention is to provide a sterilizable flexible hose made of a softened elastic PVC material as used in a biced bag set, which hose is provided with a sealing section in order to be able to be sealed later by moving opposite wall parts of the hose towards each other at that location. by locally clamping or folding the hose, characterized in that the hose is provided with an anti-adhesive agent at least locally at the location of the closing section to prevent the wall parts of the hose that have moved towards each other from being damaged during sterilization of the hose in the closed position. at the location of the pinched or folded over closure portion could permanently cleave or fuse together and prevent them from sticking together.

An advantage of this is that the sealing part of the hose can be squeezed and closed without the risk of the hose remaining closed due to the strands sticking together or fusing together during sterilization, which also ensures that the fragile connector is superfluous, The hose is preferably provided with a closing mechanism at the level of the closing section that can clamp the hose closed locally to prevent unwanted displacement of fluids and/or blood and/or components of the blood between blood bags. to omit the known breakable connector, whereby the intended closing mechanism takes over the aforementioned functions of the breakable connector, but without the presence of hard parts and/or sharp edges that would come into direct contact with the blood. avoid such connector. for example, the risk of badly broken connectors is non-existent and the passage in the relevant hose is not or hardly disturbed, so that the blood can flow through the hose relatively unimpeded. An advantage is that an unimpeded flow from the donor bag through the hose reduces the risk of mixing of strongly reduces separated layers after centrifugation, as well as the chance of generating a shear stress. Preferably, the closing mechanism is permanently attached around the hose, such that the closing mechanism cannot be lost.

The closing mechanism can be designed as a sliding clamp with a key hole-shaped passage with a round part with which the closing mechanism in the open position of the closing mechanism fits around the hose and a narrower slot-shaped part connecting to this round part with which the closing mechanism can be slid over the hose. for clamping the hose in the closed position,

An advantage of the above-mentioned closing mechanism is that it is simple to use, with a user needing only one hand to operate the closing mechanism.

In an alternative embodiment, the closing mechanism comprises a slide clamp with two slides that can move in opposite directions. The slides can each be provided with a passage through which the slides are fitted around the hose, which slides are movable with their passages relative to each other to form var a common passage with variable geometry and/or dimensions in the open position of the sliders. This offers the advantage that when sliding the sliders from a closed position with the hose clamped closed to the cpen position, the hose returns to the direction of original round shape.

With the intention of better demonstrating the features of the invention, a preferred embodiment of a sterilizable hose according to the invention and a closing mechanism therefor, as well as a blood bag set equipped therewith, is described hereinafter by way of example without any limiting character, with reference to the enclosed Drawings, in which:

figure 1 shows schematically and in front view a blood bag set provided with a sterilizable hose according to the invention; figure 2 represents the part F2 of figure 1 on a larger scale;

Figure 3 shows a front view of the closing mechanism according to arrow F3 in figure 2;

figure A shows a front view of the closing mechanism as in figure &, but in the closed position of the hose; figure 5a shows a longitudinal section through a hose of the biced bag set according to the invention at the location of a closing mechanism; figure So represents an alternative embodiment of figure 5a; figure © represents a section according to line VI-VI in figure 5; figures 7 and 8 show an alternative embodiment of the closing mechanism according to the invention, and this from different cog points:; figure 9 shows a cross-section according to line IX-IX in figure 8, with a closing mechanism in open position: figure 10 shows a cross-section as in figure 5, but with a closing mechanism in closed position;

Figures 11a and 1b show schematically the shape of the passages for the hose in the closing mechanism: Figures 12 and 13 show the mutual position of the dc-members of the [Figures 11a and 1b in different positions during use with a cross-section of the snake;

figures 14 to 16 show another alternative embodiment of the closing mechanism according to the invention, and this from different cog points.

The blood bag set 1, as shown in figure 1, contains three blood bags 2 that are mutually connected by means of hoses 3. One of the aforementioned blood bags 2a, hereinafter referred to as the donor biobag 2a, is intended to be used to collect blood during a blood test and is connected to a needle 4 via a tube 3 for this purpose.

The other Blood bags 2b and 2, hereinafter referred to as salelite bags 2b and 2c, are intended to collect separated components of the blood. The bioed bag set 1 can also be provided with a test bag 2d in which bioed can be collected for testing on Diivorebee! d quality and/or pathogens. To this end, the test bag 2d can be connected via a hose 3 to the donor blood bag Za, preferably to the hose 3 to which a needle 4 is fitted at one end.

The blood bags 2 can be provided with a liquid for blood collection,

Thus, the donor blood bag 2a is preferably provided with an anticoagulant fluid to prevent the coagulation of the blood entering the donor blood bag Za.

In addition, at least one satalite bag 2b,2c is preferably provided with a preservative, for example a storage agent such as saline-adenine glucosermannitol, which preservative is intended to store the red blood cells. The siangen 3 are made of a softened elastic PVC material that can be closed by a closing mechanism 5, for example a reversible slide nub 19 as shown in Figures 2 to 4 or a squeezable clamp 33 as shown in Figures 7 to 10, or a pleating mechanism as shown in Figures 14 to 16, this cm to avoid inadvertent movement of vice material between the blood bags 2 to avoid. Closing mechanisms 5 are necessary to ensure that the anticoagulant fluid from donor blood bag Za cannot enter test bag 2d, which could affect the test results, or enter one of the satellite bags 2b or 2c. location of a closing section of the hose 3 to be able to be closed locally by moving opposite wall parts 7 of the hoses 3 towards each other at that location by locally clamping or twisting the hoses to a closed position, as for instance shown in figures 4 , 12 and 14,

A special feature of the invention is that the hoses 3 are provided, at least locally at the location of the closing section, with an anti-cling agent 6 in order to prevent the wall parts 7 of the hoses 3 that have moved towards each other from closing while sterilizing the hoses 3. at the location of the clamped or folded closure section could permanently stick together or fuse together and prevent them from sticking together, which ensures that the hose 3 can be opened again by releasing the closure mechanism 5.

The anti-sticking agent 6 is preferably formed by an anti-sticking layer B of a material whose melting temperature or the temperature at which the material could become tacky is higher than the temperature of the sterilization process, typically a temperature between 115 and 122°C. .

In a preferred embodiment, the anti-adhesive layer 8 contains or is formed from one or more products from the following non-limitative list: - silicone; - a polyolefin; - a fluoropolymer such as PIPE (polytetrafluorocethylene)}-: - a polyester: - paper.

In the case of the embodiment of Figures 2 to 4, the non-stick layer 8 is formed by a strip 9 of the aforementioned material which extends locally or over a certain length of the hose 3 and has a width B approximately equal to half the inner circumference of the hose 3.

In this case the shut-off mechanism S comprises a sliding clamp 19 which is plate-shaped with a keyhole-shaped opening in which the hose 3 is or can be arranged.

The aforementioned opening 10 comprises a round part 11 with which the sliding clamp 19 with the hose 3 in the open position, as shown in figures 2 and 3, fits around the hose 3 and a narrower slot-shaped part 12 connecting to this round, sited 11, with which the slide clamp 19 can be slid over the closing portion of the hose 3 to clamp the hose 3 closed until it is in the closed position as shown in figure 4. An advantage is that the slide clamp 19 can be operated with one hand, both to switch from open to to go through the closed position as if to go from the closed to the open position, and this in Legend to the known breakable connectors that require both hands and can no longer be reclosed.

as shown in figures 5 to 10, it is possible, as an alternative to the embodiments of figures 2 and 3, for the non-stick layer 8 to be formed by a piece of intestine 13 arranged coaxially in the hose 3 .

The hose 3 can also be formed by co-extrusion with an outer part in softened elastic PVC and an inner part in anti-sticking agent 6.

Figure Sa shows a possible embodiment with a coaxially inserted intestine 13 without interruption of the hose 3.

In the example shown in Figure Sa, the inserted intestine 13 extends longitudinally over a portion of the hose 3.

The outer diameter E of this casing 13 is preferably equal to or slightly larger than the inner diameter D of hose 3, so that the casing 13 remains present in the fitted position in hose 3 due to the friction and/or pinching.

In this case of Figure Sa, the passage in the hose 3 is narrowed locally at the level of the intestine 13.

The reduction of the inner diameter D of hose 3 by the insertion of the aforementioned intestine 13 can, if desired, be avoided by locally interrupting the hose 3 over a certain distance À, and this interrupted part 15 can be bridged by a bridging 16 in the form of a piece of hose, the bridge being attached by gluing or the like to the ends 17 of the interrupted section 15 as shown in Figure 5b.

The bridging 16 should also be made of a relatively flexible material, for instance the same material as the hose 3. The anti-cling layer 8 in this case is formed by the intestine 13 that is enclosed in the interrupted part 15 of the hose 3, which intestine 13 has an inner diameter C which is preferably equal to the inner diameter D of the tube 3, so that the blood or a component thereof can flow through the tube 3 without constrictions and extra resistance, so that the blood or a component thereof remains intact.

Due to the fact that the intestine 13 is enclosed between ends 14 of hose 3, this causes an axial blocking of the anti-adhesive layer E.

The outer diameter E of the casing 13 is preferably equal to or greater than the inner diameter F of the bridging 16. The aforementioned non-stick layer B can also be formed by a coating of the inner side 18 of the hose 3. This can happen, at preferably locally at the location of the closing mechanism 5, with a surface treatment with a chemical product, or by an oil or ver, so that this inner side 16 of the siang 3 does not become superficially tacky.

The hose 3 should not be interrupted in this case. Such a surface cocating can also be obtained, as described in patent US4675361A, among others, by adding a component to the extruding material before the extrusion of the hose 3, for example a Dloc copolymer, which migrates to the surface of the hose during extrusion.

One can then either cut the whole hose 3 or a short piece at the place where it is ; want to place the closing mechanism 5 replaced by a hose 3 whose surface has been modified in this way with a less tacky surface, Cp area of the closing mechanisms 5 are also possible alternative embodiments as described below, Figures 7 to 13 show an alternative embodiment of a closing mechanism 5 according to the invention, wherein the closing mechanism 5 is designed as a squeezable germ 33 which in this case is U-shaped and elastic with at least one passage 27 for the hose 3 in the feed 28 of the U-shaped part and with two legs 29a and 29b, the legs 29a and 29h being provided at their ends with fingers 30 pleated towards each other, each having a passage 31a and 31b for the hose 3, as shown in Figures 11a and 11b. The germ 33 is permanently around the hose 3 arranged as shown in Figure 9, with hose 3 extending longitudinally through passage 27 in base 28 of the U-shaped portion and through the passages 31a and 315 in the aforementioned fingers 30. The fingers 30 are provided with complementary clip parts 32 which clip together in the closed position of the clip 33.

From the open position of Figure 9, the legs 29a and 295 can be pressed towards each other into a snap position, whereby the common passage through the two passages 31a and 310 in the fingers 30 becomes smaller and the hose 3 is thereby clamped closed, as shown. in figure 19. To open the germ 33, it suffices to unclip the clip parts 32, so that the elasticity of the clamp 33 returns to the open rest position of figure 9 .

In this case too, the clamp 33 can be opened and closed with one hand, just like the classic Roberts clamp, in contrast to the known breakable connectors.

Passages 31a and 31b in the fingers 30 of the clamp 33 are formed in such a way that, in the closed position of the clamp 33, they form one common and flattened passage, as shown in figure 12, the inside 18 of the wall parts 7 of the clamped hose 3 being at least lie against each other to prevent fluids and/or blood and/or components of the blood from moving around the blood bags and/or between a blood bag and the needle â,

as shown in figure 13, the passages 31a and 31b in the fingers 30 in the open position of the clamp 33 also form a common passage, but with a round shape such that at least in the closing part of the hose 3, after opening the germ 33, is pushed back in the direction of its original round shape for an optimal flow through the hose 3 without increased flow resistance as a result of a constriction that would continue to exist after the hose 3 has been clamped shut.

Figures 14 to 16 show yet another alternative embodiment of the closing mechanism 5 according to the invention, in which a closure of the hose 3 is obtained by folding the hose 3 around Le at the location of the non-stick layer 53, for instance once or twice, and keeping the hose 3 closed in this condition by, for example, using a hard or soft seed part 36 and placing this over the relevant part of the hose 3.

For such hard or soft closure mechanisms 5 use can be made of a material that preferably becomes non-sticky and/or becomes flexible and/or melts during sterilization. and/or other deformation in the hose 3. such pleat 34 and/or folded over portion and/or other deformation can result in opposite wall parts 7 of the hose 3 closing up towards each other, whereby the passage in the hose 3 is locally closed so that no unwanted flow of liquid can take place.

The closing mechanism 5, in the case of figures 14 to 216, is a piocoi mechanism which is made in two parts,

a molding 35 and clamping part 36, respectively, wherein the molding part 35 has a tubular design along its inner circumference and is arranged around the hose 3 and is intended to push the hose 3 back into its original round shape when in the open position, and wherein the clamping part 36 is intended to is to hold the hose 3 in its crimped condition in the sintered position. The clamping part 36 can be designed as a slide with an opening 37 intended to be used over the pleat 34 and/or the over-plotted portion and/or the deformation of the hose. 3 to close the hose 3 in the closed position, : To return the hose 3 to its open position, as shown in figures 15 and 16, the hose 3 can be removed from the clamping part 36, for example by whether or not ; simultaneous sliding of both parts 35 and 36.

The shaping part 35 can then be fitted over the pleat 24 and/or the folded-over portion and/or the deformation of the hose 3 to push the hose 3 back towards its original round shape.

The inner diameter H of the shaper 35 is preferably substantially equal to the outer diameter E of the hose 3.

This embodiment is the preferred embodiment when preferably no use is made of a closing mechanism 5 made of a hard material in order to avoid the risk of damage to the biodeposits in the centrifuge.

The closing mechanisms 5 as described above can also be used for clamping soft PVC hoses 2# in other applications. { The present invention is by no means limited to the embodiments described as example 9 and shown in the figures, but a sterilizable hose according to the invention and a closing mechanism therefor, as well as a blood bag set equipped therewith, can be realized in various shapes and sizes without going beyond the scope of to enter the invention,

Claims (1)

Conclusions, 11,- Sterilizable {flexible hose (3) of a softened elastic PVC material as used in a blood bag set, which hose is provided with a closing section to be able to be closed off locally by moving opposite wall parts towards each other at that location ( 7) of the hose {3} by locally clamping or folding the hose (33), characterized in that the hose {3} is provided with an anti-adhesive agent {6} at least locally at the sealing part to prevent it from being sterilized during the hose {3} in a closed position, to prevent the wall parts (7) of the hose {3} that have moved towards each other from permanently sticking together or to fuse together at the location of the clamped or folded closing section, and to prevent them from would stick to each other, Z. Sterilizable flexible hose according to claim 1, characterized in that the anti-adhesive agent (6) is formed by an anti-adhesive layer (8) of sen material whose melting temperature or the temperature at which the material could become tacky is higher than the temperature of the sterilization process, typically a temperature between 115 and 122°C. Sterilizable flexible hose according to claim 1 or 2, characterized in that the non-stick layer (8) contains or is formed from one or more products from the following non-limitative list: * silicone; = senpolvoleFine; = a fluoropolymer such as PTFE (polytetrafluoroethylene) : — a polyester: + paper, A sterilizable flexible hose according to any one of the preceding claims, characterized in that the anti-stick layer (8) extends locally or over a certain length of the hose (3) and over a width {B} which is at least equal to half inner circumference of the hose {3}, A sterilizable flexible hose according to any one of claims 1 to 4, characterized in that the anti-kist layer {8} is formed by a casing (13) inserted coaxially in the hose {3}. b.- Sterilizable {flexible hose according to one of claims 1 to 4, characterized in that the non-stick layer {8} is formed by a strip that fits axially in the hose (3) and forms a kind of partition between two radially opposite wall parts of the hose (31. 7.7 Sterilizable flexible hose according to claim 1, characterized in that the non-stick agent (6) consists of a layer of oil or fat or by a coating on the inner side {18} of the hose {3}, sterilizable flexible hose according to claims 7, characterized in that the client or grease or coating is a silicone-based oil or grease or coating on the inside (18) of the hose (3). 3. Sterizable flexible hose according to claim 7, characterized in that the non-stick agent (6) is formed by a chemical surface treatment by applying a coaling on the inside {18} of the hose {3} with a chemical product with which the PVC of the hose (3) reacts superficially and converts into a non-adhesive layer, or where the anti-adhesive agent is formed by adding an additive to the bulk material before extruding the hose, which additive migrates during extrusion to the surface and converts it into a non-tacky layer. A sterilizable flexible hose according to any one of claims 1 to 3 and 7 to 9, characterized in that the hose {3} 18 is formed by co-extrusion with an outer part in the softened elastic PVC and an inner part in anti-cling material. 11. Sterilizable flexible hose as claimed in any of the foregoing claims, characterized in that it is provided with Olocking means to limit or block the freedom of movement of the non-stick layer {8} in axial direction of the hose (3). 12. Sterilizable flexible hose according to any of the preceding claims, characterized in that the above-mentioned locking means are formed by friction with the hose 13}. [For example, through a casing with an outer diameter equal to or slightly larger than the inner diameter of the hose}. 13," Sterilizable flexible hose according to any one of the preceding claims, characterized in that the blocking means are formed by a local portion of the hose (3) with a larger diameter in which the anti-kiss layer (8) is axially confined. 14.- Sterilizable flexible hose according to claim 13, characterized in that the larger diameter local part of the hose (3) is formed by a local interruption of the hose (3) and by a piece of hose (3) made of the same material manufactured and has an inner diameter equal to or slightly smaller than the outer diameter of the interrupted hose 43) and which forms a bridging (16) of the interrupted part {15}, Sterilizable flexible hose according to one of the preceding claims, characterized in that the hose (3) at least at the height of the closing portion contains a closing mechanism {5} that is fixed around the hose (3}. 16. Sterilizable flexible hose according to claim 15, characterized in that the closing mechanism (5) is designed as a sliding clamp {159} with a key hole-shaped passage with a round part with which the closing mechanism (5) fits into the open position of the closing mechanism {5}. around the hose {3} and a narrower slot-shaped part connecting to this round part, with which the closing mechanism (5) can be slid over the closing part of the hose {3} to close off the hose (3), 17,- Sterilizable flexible hose according to claim 15, characterized in that the closing mechanism (5) comprises two or more parts (35 and 36) which are connected to each other, respectively a molding part (35) and clamping part {36}, the molding part {35} being tubular along its inner circumference. has been carried out and is intended to keep the hose {33 in its original round shape or to restore it to its original round shape and where the sprouting part {36} is intended to keep the lettuce ng {3} to clamp in closed position, 18." Sterilizable flexible hose according to Claim 1%, characterized in that the clamping part {36} is designed as a slider with an opening (37} which is intended to be passed over the PLCI (34) and/or the folded-over portion and/or the deformation of the hose {3} must be applied to close the hose {3} in closed position, 19.- Sterilizable flexible hose according to claim 17 or 18, characterized in that after opening the hose {33 the molded part {35} is placed over the pleat (34) and/or the folded-over part and/or the deformation of the hose (3 ) is applied to push the hose (3) back into its original round shape,