Abstract:
A line, in particular to a line of a blood tubing system or of a blood bag system, having a closing member blocking the line passage, with the closing member being formed by a plastically deformable closing body which is arranged in the line and which closes the line in at least one state and with at least the portion of the line in which the closing body is located being made flexible.

Description:
This is a national stage of PCT/EP2006/003937 filed Apr. 27, 2006. 
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The invention relates to a line, in particular to a line of a blood tubing system or of a blood bag system having a closing member blocking the line passage. 
     2. Description of the Related Art 
     It is known with blood tubing systems and blood bag systems known today to provide a closure which can be opened from the outside, which remains sterile and which is opened by breaking a plastic part. After the breaking of the so-called break cone, a passage for the previously enclosed or blocked liquid is released. A blood bag is known from U.S. Pat. No. 6,132,413 having a line which is closed by such a breakable member. To open the line passage, the line with the member therein is bent, which has the result that the member breaks and in so doing releases the line passage. A disadvantage of the closure known from the prior art comprises the fact that only a comparatively small cross-section is released for the flowing medium. In addition, particles arise due to the breaking off of plastic parts and said particles can enter into the organism of a patient. It is furthermore disadvantageous that sharp burrs can occur at the plastic which can cause hemolysis when blood flows through. It must finally be named as a further disadvantage that the manual breaking of the cones can cause pain for the personnel on frequent repetition of this action. 
     SUMMARY OF THE INVENTION 
     It is the object of the invention to further develop a line of the initially named kind such that its closing member can be opened such that a comparatively large cross-section is released for the flowing medium and such that furthermore the disadvantages known from the prior art of the arising of particles and of sharp burrs no longer occur. It should furthermore be made possible for the closing member also to be able to be opened by a machine. 
     This object is solved by a line, in particular a line of a blood tubing system or of a blood bag system, having a closing member blocking the line passage. Provision is accordingly made for a plastically deformable closing body to be arranged in the line which closes the line in at least one state and for at least the portion of the line in which the closing body is located to be made flexible. 
     The term “line” is to be understood with a wide meaning and includes any desired region which is flowed through such as line portions, tubes as well as connector regions of e.g. blood bag systems. 
     In the non-deformed state, the closing body blocks the line such that the passage for media is blocked. To open the passage, the closing body is deformed from the outside such that a flow of medium is possible. In this connection, the line surrounding the closing body must be so flexible that the deformation of the closing body is possible and subsequently a region is released for the flow of the medium. This can take place by restoring forces of the line itself or by outside support. 
     The closing body can be made as solid, as porous or as a hollow body which is made open or closed on one or more sides. If the plastically deformable closing body is made as a hollow body, the remaining volume of the closing body is so low after its deformation that a substantially unimpeded passage is ensured for the medium. 
     The closing body can be made in accordance with the invention such that no sharp burrs arise after its deformation which can cause damage to the blood and such that also no particles arise during the deformation which could enter into the patient&#39;s blood. 
     Since only a simple squeezing movement is required to open the closure, the present invention is particularly suitable for the processing or opening of the line by a machine. A manual opening is naturally likewise conceivable which is comfortable and ergonomically possible for the user. 
     The core of the invention comprises the fact that the closing body is brought from a shape in which it closes the line into a shape which permanently releases the passage through the line by the effect of force. 
     The closing body can be solid, it can be hollow, open or closed; it can also comprise porous material or also be hollow and have a filling. 
     In a conceivable embodiment, the closing body is filled with a liquid, preferably with a liquid compatible for the patient such as with a saline solution. Provision can be made in this connection for the liquid to be accommodated in a wrapping, for example a bag, which bursts when pressure is applied, for example by the hand, and releases the liquid. 
     To ensure good adhesion between the closing body, on the one hand, and the flexible line, on the other hand, provision can be made for the closing body and the portion of the line in which the closing body is located to be made of materials or comprise materials which adhere to one another. It can thereby be ensured that the line remains sealed up to a comparatively high internal pressure. 
     Additional possibilities of increasing the internal pressure which can be tolerated comprise the design of the surface property of the closing body and inner side of the wall of the flexible line, which can be porous or rough, for example, whereby the adhesion of the closing body to the line is improved. 
     The adhesion between the closing body and the line can be improved additionally or alternatively by materials which connect the closing body to the line, such as glue, for example. 
     In a further embodiment of the invention, provision is made for the line to have a first line part and a second line part which are in fluid-tight communication with one another at least one connection point, with the closing body closing the second line part in at least one state and with the first and second line parts being arranged at least portion-wise in that region of the second line part in which the closing body is located such that the first line part surrounds the second line part and both line parts are spaced apart from one another or can be released from one another in this region. 
     Such an embodiment of the line is in particular of advantage when high demands are made on the pressure resistance of the closure of the line. It is, for example, conceivable, that a ring-shaped peripheral space is present or arises on exertion of pressure between the first and second lines, which can both be made flexible, with a corresponding pressure prevailing in said space on the exertion of pressure onto the first line. This has the result that the second, inwardly disposed line, is pressed onto the closing body. An opening of the closure independently of the internal pressure is thereby completely prevented. 
     It can be determined by the positioning of the closing body with respect to the peripheral connection of the first and second line parts whether the pressure resistance is given by one side or by both sides of the closing body. 
     The lines, which are at least flexible in the region of the closing body, can also be components of an injection molded part or can be lines made in a different process. 
     It is particularly preferred when the first and second line parts are arranged concentrically with respect to one another. 
     Provision is made in a further embodiment of the invention that, in that portion in which the closing body is arranged in the second line part, both line parts are spaced apart from one another and that, in a region adjacent thereto, both line parts are connected to one another by means of a connection portion which extends conically, for example. 
     Provision is made in a further embodiment of the invention that the second line part is accommodated in the first line part and that the connection position in the marginal region of the second line part, or spaced apart therefrom, is, for example, arranged in a central region of the second line part. The closing body can likewise be accommodated centrally in the second line part. 
     The middle region of the closing body can be at the level of the connection point. 
     Provision can furthermore be made that the second line part is arranged partially in the first line part and partly projects therefrom, with the connection point being arranged in the end region of the first line part. 
     In a further embodiment of the invention, an adapter is provided which is plugged onto the first and second line parts. It is conceivable that the line parts have a connection point independently of the adapter and that the adapter is e.g. adhesively bonded onto the end portion of the line parts. It is furthermore conceivable that the adapter presses the line parts in a fluid-tight manner with one another to form the connection point. Provision is made in a possible embodiment that the first and second line parts terminate with one another and that the adapter is placed onto the end faces of the line ends. A further line portion can be provided in the other end region. 
     A first line part and a second line part are provided in a further embodiment of the invention, with the second line part being made in two parts and each of the parts terminating in a blunt manner at the closing body, with the first line part surrounding the second line part and being in fluid-tight communication with the parts of the second line part at both sides of the closing body. The region between the parts of the second line part and the closing body is hot made fluid tight, but medium can rather flow through it. This throughflow takes place on that side of the closing body on which pressure is exerted. The medium providing the pressure and located in the second line part flows through the region between the end face of the second line part and the adjacent end face of the closing body and enters in this manner into that region of the first line part which surrounds the closing body. This has the result that the first line part undergoes a bulging action and thereby becomes shorter in the longitudinal direction. This in turn has the result that the parts of the second line part are pressed at their end faces onto the closing body so that a reliable sealing is created. 
     The term of the “plastically deformable closing body” or of the “plastic deformation of the closing body” is not only to be understood as the case that the closing body is made plastic, but also the case that the closing body is made resiliently and that means are provided which fix the flexible or resilient closing body in a deformed position in which it at least partly releases the line passage. If the closing body is made of flexible material and if the system pressure enters into the interior of the flexile closing body, as is e.g. the case with a piece of flexible line closed at one side, the closing body can expand under pressure with the flexible line surrounding it, whereby the closure remains sealed. So that the closing body does not return to its original shape, which closes the line, after its deformation, the flexible closing body must be held in that position in which it at least party releases the line passage. It is, for example, conceivable for this purpose for the flexible or resilient body to be combined with plastic materials. 
     Any other means can also be used with which the restoration of the deformed resilient closing body into its closing position is prevented. It is e.g. conceivable that glue is provided for this purpose. This can e.g. fix regions of the closing body adjacent to one another in this position in the deformed state. It is e.g. possible that the closing body is made hollow and has an adhesive layer on its inner side. 
     Furthermore a hook and loop fastener can be provided as the means fixing the closing body in its deformed position. It can, for example, be arranged on the inner side of a closing member made as a hollow body and can ensure in the deformed state that the adjacent walls of the closing body are fixed to one another. It is generally also conceivable that a part of the hook and loop fastener is arranged at the line and the complementary part of the hook and loop fastener is arranged at the closing body. 
     The present invention furthermore relates to a method of opening a line, with the closing body being plastically deformed from that state in which it closes the line for the purpose of opening the line such that a passage through the line is released. The deformation preferably takes place from the outside, i.e. through the line. 
     The deformation of the closing body for the purpose of releasing the passage can be carried out, for example, by means of a tool. An advantage of the invention comprises the fact that not only a manual actuation is possible, but also an actuation by a machine. The tool can thus be a component of a machine or apparatus for the opening of the line. The use of hand-actuated pincers is also conceivable. 
     The tool can be a tool with smooth jaws. It is likewise conceivable that the tool has one jaw with a projection and one jaw with a recess into which the projection engages when the tool is closed. 
     A deformation of the closing body preferably takes place such that it is fixed against displacement in the line after its deformation. Such an embodiment of the invention makes the use of special holding or fixing members superfluous which prevent a displacement of the closing body after its deformation. Embodiments of the invention are naturally also conceivable in which such fixing means are provided. 
     The invention furthermore relates to a blood tube or to a blood bag having a line in accordance with the invention. 
     Metals such as aluminum or plastics such as polyethylene can be considered as materials for the closing body, for example. The plastic can then be made brittle and can be comminuted into individual parts on its deformation. 
     If the line should be used in the medical field, provision is preferably made that the closing body is blood-compatible or has a blood-compatible coating. 
     The introduction of the closing body into the line can take place, for example, in that the closing body is mechanically inserted into the line. To ensure a good fit and a good seal, the external dimensions of the closing body should be slightly above the internal dimensions of the line so that the line is slightly extended on insertion and the closing body remains at the desired position and is sealingly accommodated in the line. 
     It is also conceivable to shrink the line at least in that region in which the closing body is located after the introduction of the closing body into the line. The line can thus also be shrunk onto the closing body. The process of shrinking advantageously takes place under the effect of heat. It is conceivable that the shrinking takes place during the heat sterilization. It is equally naturally possible to carry out the procedure of shrinking independently of the heat sterilization. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Further details and advantages of the invention will be explained in more detail with reference to an embodiment shown in the drawing. There are shown: 
         FIGS. 1 to 4 : a schematic representation of the steps in the deformation of a closing body by means of a tool in a first embodiment; 
         FIGS. 5 to 8 : a schematic representation of the steps in the deformation of a closing body by means of a tool in a second embodiment; 
         FIG. 9 : a schematic representation of a line having a first line part and a second line part in which the closing body is located in an embodiment resistant to pressure on one side; 
         FIG. 10 : a schematic representation of the line having a first line part and a second line part in which the closing body is located in an embodiment resistant to pressure on two sides; 
         FIG. 11 : a schematic representation of the line having a first line part and a second line part in which the closing body is located in a further embodiment resistant to pressure on one side; 
         FIG. 12 : a schematic representation of the line having a first line part and a second line part in which the closing body is located in a further embodiment pressure tight on one side with an adapter; 
         FIGS. 13, 14 : schematic representations of the line having a first line part and a second line part which is made in two parts in an embodiment pressure tight on two sides before the exertion of pressure ( FIG. 13 ) and after the exertion of pressure ( FIG. 14 ); and 
         FIG. 15 : a cross-sectional view of the line with a deformed closing body with detailed representations. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Further scope of applicability of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description. 
       FIG. 1 , left hand representation, shows a tool  50  which can be actuated manually or by a machine and which has a jaw  54  with a semi-circular projection  55  and a jaw  56  in which a likewise semi-circular recess  57  is arranged, with the diameter of the recess  57  being above that of the projection  55 . 
       FIG. 1 , middle representation, shows the line  10  in accordance with the invention in a schematic cross-sectional view, said line being closed by the closing body  20 . The closing body  20  is located in that portion  12  of the line  10  which is made flexible. Embodiments are also conceivable in which only that portion  12  is made flexible in which the closing body  20  is located. It is likewise conceivable that the total line  10  is made flexible. 
     The closing body  20  can be made solid, hollow, open to one side of the line or fully closed. It can comprise porous and impermeable material or also be made hollow and have a filling. 
     To improve the adhesion between the closing body  20  and the inner side of the wall of the line in the portion  12 , provision can be made for adhesive to be arranged between both members, said adhesive having to be metered such that the desired sealing effect is achieved, but the connection nevertheless remains releasable for the case that the passage through the line  10  should be opened. 
       FIG. 1 , right hand representation shows the line  10  in accordance with the invention in a schematic longitudinal sectional view, with the closing body  20  being accommodated in the portion  12  of said line such that it closes the line  10 . 
       FIG. 2  shows the accommodation of the line  10  in the tool  50 . As can be seen from  FIG. 2 , the radius of the recess  57  of the jaw  56  of the tool  50  approximately corresponds to the outer diameter of the portion  12  of the line  10 . The line  10  is fixed in the recess  57  by means of the projection  55 , as can be seen from  FIG. 2 . 
     If the tool  50  is actuated by machine or by hand, that is if the jaws  54 ,  56  are guided together, the line portion between the jaws  54 ,  56  is squeezed, as is indicated in  FIG. 3 . The closing body  20  is plastically deformed in this process. Due to the embodiment of the recess  57  and of the projection  55 , the shape of part of a circle results for the closing body  20  during deformation, as can be seen from  FIG. 3 . The force for the deformation of the closing body  20  is transmitted through the wall of the line  10 . 
       FIG. 4  shows the arrangement after the opening of the tool  50 . As can be seen from  FIG. 4 , the closing body  20  remains in its deformed position and thereby permanently releases a passage through the line  10 . The line  10  or its portion  12  again adopts the original design before the deformation process due to the flexible embodiment. 
     The line  10  or is portion has the same shape before and after the deformation. 
       FIG. 5  shows a tool  50  with jaws  52  made smooth. The design of the line  10  with a closing body  20  corresponds to the embodiment with respect to  FIGS. 1 to 4 . 
       FIG. 6  shows the positioning of the line  10  with a closing body  20  between the jaws  52  of the tool  50 . 
     The state is shown in  FIG. 7  which results during the compression of the jaws  52  of the tool  50 . During compression, the closing body  20  is brought into a shape which holds it in place in the portion  12  of the line  10  after the opening of the tool  50  and nevertheless releases a large passage in the line  10 . The force for the deformation of the closing body  20  is transferred through the wall of the line  10  which is flexible at least in the portion  12 . 
       FIG. 8  shows the arrangement after the opening of the tool. As can be seen from  FIG. 8 , left hand representation, the closing body  20  is permanently deformed and adopts the shape of a strip. The closing body  20  divides the portion  12  of the line  10  into two passage regions above and below the deformed closing body  20 . The closing body  20  is permanently located in a shape which fixes it in place after the deformation. For this purpose, as can also be seen from the schematic longitudinal portion in accordance with  FIG. 8 , right hand representation, the flexible part  12  of the line  10  is extended by the shape of the closing body  20 , which results in a restoring force of the portion  12  of the line  10 . This force holds the deformed closing body in place in its new shape. 
     If high demands are made on the pressure resistance of the flexible line, embodiments are possible which permit any desired pressure resistance from a construction aspect. Provision is made for this purpose that the first flexible line is supplemented by a second flexible line which is arranged such that the second flexible line extends at least portion-wise inside the first flexible line. 
     Provision is preferably made in this connection that the first and second lines are connected to one another such that a ring-shaped, peripheral closure arises between both lines. The closing body is located in the interior of the second line. Both lines are preferably made flexible. 
       FIG. 9  shows an embodiment of the invention in this design. The line  10  includes a first line part  14  and a second line part  16 , with the closing body  20  being located in the second line part  16  such that it closes it. The second line part  16  has an inwardly projecting web  100  which is contacted by the closing body  20 , on the one hand, and by a further line part  110 , on the other hand, which represents the connection to further vessels or to the outlet. 
     As can be seen from  FIG. 9 , the first line part  14  and the second line part  16  are mutually arranged in that region of the second line part  16  in which the closing body  20  is located such that the first line part  14  concentrically surrounds the second line part  16 . A ring-shaped space  11  results in this region between both line parts  14 ,  16 , i.e. both line parts  14 ,  16  are radially spaced apart from one another in this region. If a pressure acts in the first line part  14 , as is indicated by the vertically arranged arrow, this has the result that a force directed to the closing body  20  is exerted onto the portion of the second line part  16  in the space  11  in accordance with the double arrows, whereby an opening of the closure independently of the internal pressure is completely prevented. 
     The conically tapering region  17  which connects the cylindrical portion of the first line part  14  to the second line part  16  adjoins the cylindrically extending portion of the first line part  14 . In the end region of the conical portion  17 , the two line parts  14 ,  16  are connected to one another in a fluid-tight manner while forming the connection point  18 . 
     It is conceivable that the first line part  14  is adjacent to the second line part  16  in the state not acted on by pressure and the position shown in  FIG. 9  only results in the state acted on by pressure. An embodiment is furthermore feasible in which a spacing is also formed between both line parts  14 ,  16  in the state not acted on by pressure while forming the ring space  11 . 
     It can be determined by the positioning of the closing body with respect to the peripheral connection of the first and second line parts  14 ,  16  whether the pressure resistance is given by one side or by both sides of the closing body  20 . 
     As stated above, the line parts  14 ,  16  are made flexible at least in the region of the closing body. 
       FIG. 10  shows an embodiment of the line  10  in accordance with the invention in which the second line part  16  is completely surrounded by the first line part  14 , with both line parts  14 ,  16  contacting one another in the pressure-less state, as is illustrated in  FIG. 10 . The closing body  20  is sealingly accommodated in the second line part  16 . The two line parts  14 ,  16  are fixedly connected to one another in a fluid-tight manner at the peripheral connection point  18 . If the first line part  14  is extended due to the inner pressure prevailing therein, a gap is created between the line parts  14 ,  16  in which the pressure can propagate such that it presses the second line part  16  onto the closing body  20 , whereby a reliable sealing is achieved. 
     The connection point  18  between the line parts  14 ,  16  is located approximately centrally at the second line part  16 . The closing body  20  is likewise received approximately centrally in the second line part  16  so that an embodiment pressure-tight on two sides results overall. 
       FIG. 11  shows an embodiment pressure-tight at one side in which the second line part  16  is partly received inside the first line part  14  and projects beyond it in part. The connection point  18  which connects the line part  14 ,  16  to one another in a fixed and fluid-tight manner is located in the end region of the first line part  14 . The closing body  20  is located in the second line part  16  in that portion in which the second line part  16  is received in the first line part  14 . If the first line part  14  is loaded with pressure, this has the result that a gap arises between both line parts  14 ,  16 , with the pressure prevailing in the gap pressing the region of the second line part  16  bounding the gap onto the closing body  20 . 
       FIG. 12  shows a further embodiment of a design pressure-tight on one side in which the line parts  14 ,  16  terminate flush with one another. An adapter  30  is provided in this end region of the line parts  14 ,  16  which is placed onto the end regions of the line parts  14 ,  16  and which presses them to one another in a fluid-tight manner while forming the connection point  18 . It is also feasible that the adapter  30  is connected to the line parts  14 ,  16  by means of adhesive bonding. It also results from this embodiment that, on an application of pressure on the first line part  14 , a gap or an annular space results between the two line parts  14 ,  16 , with the pressure prevailing therein pressing the second line part  16  onto the closing body  20 . 
     A line is designated by the reference numeral  110  which extends to further vessels or to an outlet and is in fluid-tight communication with the adapter  30 . 
       FIGS. 13 and 14  show a further embodiment of the present invention in an embodiment pressure-tight on two sides. In this embodiment, the second line part  16  is made in two pieces, with both parts  16 ′,  16 ″ of the second line part  16  bluntly bordering the closing body  20  arranged between them. In this connection, the outer sides of the two parts of the second line part  16  are flush with the outer side of the closing body  20 . Furthermore, a first line part  14  is provided which concentrically surrounds the closing body  20  as well as the regions of the parts of the second line part  16  which are adjacent to the closing body  20 . The parts of the second line part  16  are connected in a fluid tight manner to the first line part  14  at both sides of the closing body  20 . 
     If the arrangement in accordance with  FIG. 13  is acted on by pressure, as is indicated in  FIG. 14  by the vertically arranged arrow  140 , this has the result that the pressure-carrying medium flows between the end face of a part  16 ″ of the second line part  16  and of the adjoining end face of the closing body  20  and results in a bulging of the first line part  14 , as can be seen from  FIG. 14 . An arched annular space thereby results between the outer side of the closing body  20  and the inner side of the adjacent line part  14 . The bulging (arrows  160 ) of the first line part  14  caused by the exertion of pressure in the region in which the closing body  20  is located has the result that both parts  16 ′,  16 ″ of the second line part  16  experience the force indicated by the arrows  150  in the direction of the closing body  20 , which has the result that the end faces of the parts of the second line part  16  are pressed onto the adjoining end faces of the closing body  20  and ensure the sealing. 
       FIG. 15 , top, shows a cross-sectional view of the line  10  in accordance with the invention with the deformed closing body  20  accepted therein. As can be seen from  FIG. 15 , top, the deformed closing body  20  releases a substantial part of the line cross-section. 
     As is stated above, the closing body  20  can comprise a plastic material or also a resilient material. Combinations of elastic and plastic materials can also be used. 
     If the closing body  20  is resilient or flexible, it must be ensured that it does not again adopt its original shape closing the line  10  after its deformation. Any desired means which hold the flexible closing body  20  in its deformed position are conceivable for this purpose. 
     The illustrations in accordance with  FIG. 15 , middle and bottom representations, are detailed representations of the detail A in  FIG. 15 , top, which disclose two different alternatives how the flexible closing body  20  can be held in the deformed position. 
       FIG. 15 , middle illustration, shows the two walls of the closing body  20  which are each provided with an adhesive layer  70 . If these adhesive layers  70  are guided toward one another, as is the case with the deformation of the closing body  20  and as is shown in  FIG. 15 , middle illustration, this has the result that the closing body  20  is fixed in its deformed position shown in  FIG. 15 .  FIG. 15 , bottom illustration, shows an alternative embodiment in which the inner sides of the walls of the closing body  20  are provided with a hook and loop fastener  80  which likewise has the effect that the deformed closing body  20  remains in its deformed position. 
     In the embodiment shown in  FIG. 15 , the closing body  20  is made, for example, as a hollow body open at one side whose inner walls are provided with the adhesive layer  70  or with the hook and loop fastener  80 . 
     Other means than those shown can naturally also be used to ensure that the closing body  20  remains in its deformed position. 
     The invention being thus described, it will be apparent that the same may be varied in many ways. Such variations are not to be regarded as a departure from the spirit and scope of the invention, and all such modifications as would be recognized by one skilled in the art are intended to be included within the scope of the following claims.