Abstract:
The present invention relates to a device for interrupting a bloodstream flowing through a cavity, whereby the device displays a pipe-shaped cavity and a dilatable component with an aperture positioned in the cavity. Via the aperture, the at least one dilatable component is confluent with a fluid connection, whereby the at least one dilatable component is convertible from a non-dilated into a dilated state by feeding a fluid in from the fluid connection through the aperture. Moreover, mechanisms are provided in the fluid connection that control the feed-in of the fluid into the at least one dilatable component, the mechanisms being controllable via a second fluid.

Description:
RELATED APPLICATIONS  
       [0001]     This application claims the benefit of German application No. 10 2005 045 663.4, filed Sep. 13, 2005.  
       BACKGROUND OF THE INVENTION  
       [0002]     1. Field of the Invention  
         [0003]     The present invention relates to a device for interrupting a bloodstream flowing through a cavity in an extracorporeal circulation circuit, with a dilatable component which can be brought from a non-dilated state into a dilated state and which interrupts the blood flow when in the dilated state.  
         [0004]     Extracorporeal sanguiferous systems are used, for example, within the frame-work of an extracorporeal lung support in order to offer patients with a dysfunctional lung extracorporeal gas exchange.  
         [0005]     In the case of extracorporeal circulation circuits, and especially when series-connecting appliances such as oxygenators or dialyzers, there is often a risk of gas penetrating the blood circulation system and making its way across the system of tubes into the patient&#39;s blood vessels, triggering embolisms there. In order to avoid this, fast interruption of the blood flow is necessary. To do this, the sanguiferous tubes are usually clamped as soon as it is realized that gases are being conveyed around the bloodstream in the form of bubbles.  
         [0006]     Traditional techniques include manually or automatically actuated devices with which the blood flow through the tubes can be interrupted by exerting pressure on the external tube walls.  
         [0007]     The primary drawback of these traditional devices—brought about by the great expenditure of force necessitated—is the delay period, which prohibits the use of such systems, given the ever shorter external retention times of the blood.  
         [0008]     2. Related Prior Art  
         [0009]     From European Patent EP 0 373 847 a membrane oxygenator is known, featuring a device for maintaining the pressure automatically. Among other things the device presents a valve with an internal tube, onto which pressure can be exerted from the outside. The valve further serves to stem the flow of the oxygenating gases leaving the oxygenator utilizing the pressure of the blood leaving the oxygenator. The valve disclosed here therefore serves purely to maintain a pressure with which the oxygenating gas in the oxygenator is regulated .  
         [0010]     Thus, for instance, DE 40 12 525 discloses an actuation device for a tube system, the actuation device being able to be used optionally to block or to clear cross-sections of tubes. Also with this device, however, the tube, or alternatively the tube segments, are mechanically pressed shut, should blocking of the tube system be desired.  
         [0011]     From EP 0 706 343 B1 a circulatory system with a blood pump and occlusion device is known, in which, via a tube, the blood is in flow connection with the blood vessel of the person to be treated. Furthermore, a sealing device is provided to regulate the flow of the blood pump. In addition, the system includes regulation mechanisms for operationalizing the obturation device in the event of a malfunction in the blood pump.  
         [0012]     An object of the present invention is thus to provide a device with which a fluid flow, particularly in extracorporeal blood circulation circuits, can be interrupted with great speed and efficiency.  
       SUMMARY OF THE INVENTION  
       [0013]     According to the invention this object is performed by a refinement of the device mentioned by way of introduction, in which the device further displays at least one dilatable component positioned in the sanguiferous cavity, with an opening via which the at least one dilatable component is fluidly connected with a fluid connection, whereby the at least one dilatable component is convertible from a non-dilated into a dilated state by feeding a fluid in from the fluid connection through the opening, whereby moreover elements are provided in the fluid connection that control the feed-in of the fluid into the at least one dilatable component, the mechanisms being controllable via a second fluid.  
         [0014]     Furthermore, the invention concerns a process for interrupting a bloodstream in an extracorporeal circulation circuit, whereby the device according to the invention is utilized.  
         [0015]     Finally, the use according to the invention comprises the use of the device according to the invention for interrupting a bloodstream in an extracorporeal circulation circuit.  
         [0016]     The object on which the invention is based is thereby performed perfectly. The device according to the invention makes it possible for the first time to effectively and very rapidly interrupt a fluid flow in a cavity system, for example the bloodstream in a system of blood tubes. System activation is effected, for instance, by means of an upstream bubble detector, which activates the device as and when required.  
         [0017]     The invention is particularly well suited to extracorporeal blood circulation circuit tubing systems in which the bloodstream needs to be interrupted quickly in the event that gaseous or corpuscular substances are detected in the blood being returned to the human body. The device according to the invention is not confined to extracorporeal blood circulation circuits, however, but can also be utilized for any other purpose calling for the flow of a fluid to be stemmed by means of a simple and quick process.  
         [0018]     In this case, the preferred fluid connection is a reservoir.  
         [0019]     It is also preferable for the reservoir to be positioned outside the cavity. By having the reservoir positioned outside the cavity, the fluid can be piped out of the reservoir via an opening in the dilatable component, thus bringing the dilatable component into an expanded state and thereby blocking the flow path. The fluid with which the dilatable component is brought into the dilated state can be either a liquid or a gas of suitable viscosity.  
         [0020]     Using the elements provided in the reservoir, the feed-in of the fluid with which the dilatable component is to be brought into a dilated state can be controlled. By controlling the fluid, it travels out of the reservoir and across the opening into the dilatable component, which widens in the process and seals the cavity.  
         [0021]     It is particularly preferable in this respect if the volumetric quantity of fluid contained in the reservoir is at least equal to the volumetric quantity of the dilatable component in the expanded state.  
         [0022]     This guarantees that the dilatable component is sufficiently expanded to seal off the cavity completely. To this end, the pipe-shaped cavity can be either a tube, a connector or any other tube-shaped system.  
         [0023]     In one embodiment it is preferable if the at least one dilatable component is a balloon. In the non-expanded state the balloon will eventually be located in the flux of the fluid flowing through the cavity system and will seal off this flow path as a result of its conversion into the dilated state.  
         [0024]     To this end it is particularly preferred if, in the expanded state, the balloon forms a tightly sealed fit against an annular constriction in the flow channel. This guarantees that even when the flow pressure is high the fluid flux is interrupted effectively and completely. In the process, the expanded balloon positions itself with its outer casing against the annular constriction, which molds to its external shape and design, the adjacent streaming pressure supporting the sealing function.  
         [0025]     In another embodiment, for example, the dilatable component can be a dilatable inner tube which—in the manner of a ring—is positioned in the cross section of the cavity, running around its inner wall, and when a fluid is fed in through the opening into the inner tube is subject to such expansion that the cavity system is sealed by the fully expanded inner tube and the bloodstream flowing through the cavity system is throttled.  
         [0026]     In the case of this embodiment, interruption to the cavity system and interruption to the bloodstream subsequently take place from the outside inwards with reference to the cross section of the cavity system. In the case of the aforementioned embodiment example of the dilatable balloon, which is positioned in the cavity, blocking of the cavity and, respectively, of the flux flowing through it, takes place from the inside outwards.  
         [0027]     The latter embodiment also guarantees that sealing of the cavity system can be undertaken more quickly, should this be desirable for instance in the case of gases penetrating the blood.  
         [0028]     From a technical point of view it is clear that a layout is conceivable in which such expandable components are set out in a multitude of arrangements.  
         [0029]     In a preferred embodiment the mechanisms provided in the reservoir represent a piston movably positioned in the reservoir via a second fluid.  
         [0030]     Hence, in the case of this embodiment—if a fluid flowing in a cavity has to be interrupted—a piston can be introduced into the reservoir via a second fluid, the fluid contained in the reservoir being forced by means of displacement from the reservoir through the opening of the dilatable component into this. This embodiment has the advantage that an exactly dosed amount of fluid can be quickly carried over into the expanding component and generates an accurately definable pressure here.  
         [0031]     It is self-evident that the piston is accommodated in the reservoir in a sealing fashion, i.e. together with the reservoir the piston limits the space for the first fluid.  
         [0032]     In the process, the piston motion, as described, is controlled by a second fluid, which presses the piston into the reservoir. The first fluid present in the reservoir is thereby displaced into the dilatable component.  
         [0033]     On retraction of the piston, the fluid displaced into the dilatable component by negative pressure is returned to the reservoir, whereby the dilatable component is again converted into its non-dilatable state. This enables the blood flow to be interrupted quickly and efficiently on the one hand and reliable clearance of the cavity to be achieved on the other.  
         [0034]     In another embodiment it is preferable if the means provided in the reservoir represent a second dilatable component, which in the reservoir is to be brought from a non-dilated state into a dilated state by feeding the second fluid into the second dilatable component.  
         [0035]     In the case of this embodiment, therefore, the second fluid is introduced into the second dilatable component provided in the reservoir. The component is thereby dilated, its volume displacing the first fluid located in the reservoir. Having thus been displaced from the reservoir, the first fluid is forced into the first dilatable component via the opening of the first dilatable component, which is fluidly connected with the reservoir by virtue of this opening, whereby the component expands to seal off the cavity. This embodiment also has the advantage of being able to achieve speedy interruption of the bloodstream through the cavity, thereby advantageously avoiding the continued conveyance of particulate gases or solid matter in the bloodstream.  
         [0036]     To this end, the second dilatable component provided in the reservoir is positioned on a wall of the reservoir so that its dilatable part protrudes into the reservoir, simultaneously sealing it off tightly. In addition, the second dilatable component presents an opening via which it is fluidly connected with the space outside the reservoir, more particularly an inlet for the second fluid. This embodiment, too, therefore, advantageously ensures that the first fluid located in the reservoir cannot escape via locations that are not sealed. This embodiment, too, therefore, advantageously guarantees that the first fluid located in the reservoir is reliably carried over into the first dilatable component.  
         [0037]     In a further embodiment it is preferred if the mechanisms provided in the reservoir represent a membrane, which—by feeding in the second fluid—in the reservoir is convertible from an initial position into a second position.  
         [0038]     In the case of this embodiment, therefore, there is a membrane located in the reservoir which can span the reservoir, e.g. along its full length, thereby dividing it into an initial space, which—directly—is fluidly connected with the dilatable component via the opening, and a second space, which is fluidly connected with the second fluid. The membrane is located in an initial position when the dilatable component is in the non-dilated state. In this respect there is, in the space of the reservoir, which—directly—is fluidly connected with the dilatable component, a specific quantity of the first fluid. Owing to the reservoir&#39;s direct confluence with the dilatable component, the first fluid may thus be partly present in the dilatable component, though without converting it into an expanded state when the membrane is located in the initial position.  
         [0039]     If the second fluid is introduced into the space of the reservoir, which is fluidly connected with the second fluid, pressure is exerted on the membrane. In the process the membrane is brought from an initial position into a second position, whereby the membrane is shifted into the initial space of the reservoir, in which the first fluid is present. The first fluid is thus ousted from the reservoir and forced into the first dilatable component via the opening in the first dilatable component, which is fluidly connected with the reservoir via this opening, with this component expanding to seal the cavity.  
         [0040]     This embodiment also has the advantage of being able to achieve speedy interruption of the bloodstream through the cavity, thereby advantageously avoiding the continued conveyance of particulate gases or solid matter in the bloodstream.  
         [0041]     In the present case “membrane” means any component designed in the form of a foil, film, coating or leaf which displays on the one hand elastic properties and on the other hand sufficient resilience to counteract a specific pressure generated by a fluid or to yield to it. The membrane can thus feature a similar material or can consist of this, as with the second dilatable component in the embodiment described above. It is particularly preferred if the material concerned is proof or virtually proof against water vapor.  
         [0042]     Overall, in the case of the device according to the invention, it is further preferred if a valve is provided with which the feed-in of the second fluid is adjustable.  
         [0043]     It is preferred, moreover, if the first fluid provided in the reservoir is selected from a series of highly viscous liquids or gases, e.g. from the series of infusion solutions, physiological salines, blood expanders, artificial blood etc.  
         [0044]     It is further preferred if the second fluid controlling the mechanisms provided in the reservoir is selected from the series of gases or alternatively mixtures thereof, e.g. atmospheric air.  
         [0045]     This has the advantage that if, contrary to expectations, a leak in the first dilatable component should occur, it is guaranteed that there will be no passage of harmful or toxic substances when used in the extracorporeal blood circulation circuit.  
         [0046]     It is further preferred if the first dilatable component displays a hemocompatible material when used in extracorporeal circulation.  
         [0047]     Any reaction of the blood transported in the cavity as a result of contact with the material is thus avoided, which in the case of non-hemocompatible materials can lead, for example, to activation of the complement.  
         [0048]     In the case of the device according to the invention, interruption of the fluid flow can be halted by de-aerating the second balloon or retracting the piston kept in the reservoir. This will serve to ensure that the first fluid flows back into the reservoir through the opening and out of the first component dilated by the fluid. In this way—as described above—the at least one dilatable component is converted back into a non-expandable state and the path through the cavity cleared. As a result, the device according to the invention remains open to multiple applications.  
         [0049]     The invention further relates to a process with which the bloodstream in an extracorporeal circulation can be interrupted, for which purpose the device according to the invention is used.  
         [0050]     The device according to the invention can further be utilized to interrupt a bloodstream in extracorporeal circulation, particularly in an extracorporeal lung support with a lung-assist device.  
         [0051]     Additional advantages are illustrated in the description and the drawings enclosed.  
     
    
     BRIEF DESCRIPTION OF THE FIGURES  
       [0052]     Examples of embodiments of the invention are displayed in the drawing and will be elucidated further below by means of a description. In the figures:  
         [0053]      FIG. 1   a  shows a longitudinal section through the device according to the invention with a dilatable balloon as the dilatable first component and an additional dilatable balloon provided in the reservoir, both balloons being in the non-dilated state;  
         [0054]      FIG. 1   b  shows the device from  FIG. 1   a , this time with both balloons in the dilated state;  
         [0055]      FIG. 2   a  shows a further embodiment of the device according to the invention in the longitudinal section, whereby at least one first dilatable component is a balloon and, furthermore, a piston is provided, positioned movably in the reservoir;  
         [0056]      FIG. 2   b  show the device from  FIG. 2   a , with the balloon in the expanded state this time as a result of the piston having been introduced;  
         [0057]      FIG. 3   a  shows a further embodiment of the device according to the invention, whereby a at least one first dilatable component is a dilatable tube guided along the cross section of the cavity, and an additional dilatable balloon is provided in the reservoir, both components being in the non-dilatable state;  
         [0058]      FIG. 3   b  shows he device from  FIG. 3   a , with both dilatable components expanded;  
         [0059]      FIG. 4   a  shows yet another embodiment of the device according to the invention, whereby the dilatable component as in  FIG. 3   a  and  3   b  is a tube guided along the cross section of the cavity interior and whereby—as shown in  FIG. 2   a  and  2   b —a piston is positioned movably in the reservoir;  
         [0060]      FIG. 4   b  shows the device from  FIG. 4   a , whereby the inner tube is in the expanded state as a result of the piston having been inserted into the reservoir and as a result of the fluid originally present in the reservoir thus flowing into the inner tube;  
         [0061]      FIG. 5   a  shows a further embodiment of the device according to the invention, whereby the first dilatable component is a balloon and a movable membrane is additionally provided in the reservoir, located in first position; and  
         [0062]      FIG. 5   b  shows the device from  FIG. 5   a , whereby the fluid present in the reservoir brings the balloon into the expanded state by bringing the membrane in the reservoir from an initial position into a second position. 
     
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0063]     In  FIG. 1   a ,  10  as a whole designates a device for interrupting a bloodstream flowing through a cavity  12 . The device  10  displays a first dilatable element  14  in the form of a balloon, which in  FIG. 1   a  is in the non-dilated state. The component displays an opening  16  via which it is fluidly connected with a reservoir  18 . In the reservoir  18  is the first fluid, with which the dilatable element  14  can be brought into an expanded state. The device  10  further displays a second dilatable element  22 , which protrudes into the reservoir  18 , this element  22  being in the non-dilated state in  FIG. 1   a . The second dilatable element  22  displays an opening  24  via which it can be dilated with a second fluid.  
         [0064]     In the device  10  in  FIG. 1   a , a ring-shaped (cross-sectional) constriction in the cavity  12  is further characterized by the reference sign  26 , against which the dilated element  14  forms a tight seal.  
         [0065]     In  FIG. 1   b  the dilatable element  14  is in the dilated state, just like the dilatable element  22  in the reservoir  18 .  
         [0066]     Operation of the device according to the invention is such that if the blood-stream is to be interrupted—e.g. owing to the ingress of gas—the dilatable element  22  is put into a dilated state by the introduction of a second fluid through the opening  24 . By increasing the volume of the dilatable element  22 , the fluid present in the reservoir  18  is displaced through the opening  16  into the dilatable element  14 . As a result of the flowing fluid, the dilatable element  14  is put into a dilated state in which the dilatable element  14  forms a tight seal against the annular projection  26 , thereby sealing off the cavity  12 . The fluid flow, or alternatively interruption of the same, in the device  10  is indicated in  FIG. 1   a  and  1   b  with arrows.  
         [0067]      FIG. 2   a  shows another embodiment of the device according to the invention  30 , whereby those elements that are common with elements of the embodiment from  FIG. 1   a  and  1   b  are designated with the same reference signs.  
         [0068]     This embodiment also displays a dilatable component  14  present in the cavity  12  with an opening  16  via which the dilatable component  14  is fluidly connected with a reservoir  38 . The dilatable component  14  lies in the direction of flow in the cavity  12 , in a non-dilated state ( FIG. 2   a ). In the reservoir  38  a piston  32  is positioned displaceably. The piston  32  displays a pin  34  guided along a groove, via which the excursion of the piston  32  in the reservoir  38  can be limited.  FIG. 2   a  shows an initial position of the piston  32 , in which the bulk of the reservoir  38  is cleared, leaving space in the reservoir  38  for the fluid. The migration of the piston  32  out of the reservoir  38  is restricted by the pin  34 , which at one point  36  of the reservoir  38  abuts against its walling and thereby stops the travel of the piston  32  out of the reservoir  38 .  
         [0069]      FIG. 2   b  shows the piston  32  in the reservoir  38  displaced into a second position, the fluid present in the reservoir  38  having been displaced through the opening  16  into the dilatable component  14 . In the process, the dilatable component  14  is converted into an expanded state and forms a tight seal at the point  26  on the annular constriction in the cavity system  12 , thereby interrupting the bloodstream in the cavity system  12 . Insertion of the piston  32  into the reservoir  38  is thus limited by the pin  34  striking against a second point  37  of the reservoir  38  walling.  
         [0070]     The piston  32 , or alternatively its insertion, is thus controlled via a second fluid, which is fed in and siphoned off via the aperture  39 .  
         [0071]      FIG. 3   a  shows another embodiment of the device according to the invention  40 , elements similar to those in  FIG. 1  and  2  again having been designated by the same reference signs. The device  40  once again displays a reservoir  18  as well as a dilatable element  22  in that reservoir  18  with an opening  24  via which the second fluid can be supplied. The device  40  further displays a dilatable component  44  in the shape of a tube guided to the inner wall of the cavity  12 , which in  FIG. 3   a  clings in the non-dilated state to the inner surface of the cavity  12  along its cross section. The dilatable element  44  is connected to the reservoir  18  via an opening  46 .  
         [0072]     If the second dilatable component  22  is now put into an expanded state by feeding in a fluid via the opening  24 , the fluid present in the reservoir  18  is displaced via the opening  46  into the first dilatable element  44 , whereby this is once again converted into a dilated state. The dilatable element  44 , present in  FIG. 3  as a tube, thus seals the cavity  12  into a dilated state. This position is shown in  FIG. 3   b.    
         [0073]     By siphoning the second fluid out of the dilatable element  22  in the reservoir  18 , the dilatable element  22  is converted into a non-dilatable state. Through this reduction in volume, the first fluid is returned to the reservoir  18  by negative pressure, whereby the dilatable element  44  is again converted into the non-dilated state.  
         [0074]      FIG. 4   a  shows a further embodiment of the device according to the invention  50  which, as in  FIG. 3 , displays a dilatable element  44  in the form of a tube guided on the inner wall of the cavity  12 , shown in  FIG. 4   a  in the non-dilated state. The dilatable element  44  in  FIG. 4   a  clings in the non-dilated state to the inner surface of the cavity  12  along its cross section. The dilatable element  44  is fluidly connected with the reservoir  38  via the opening  46 .  
         [0075]     The reservoir  38  in  FIG. 4  is fitted with a piston  32 , positioned movably in the reservoir  38 . As in  FIG. 2  the piston  32  displays a pin  34  guided along a groove, via which the migration of the piston  32  in the reservoir  38  can be limited.  FIG. 4   a  shows an initial position for the piston  32 , in which the bulk of the reservoir  38  is cleared, thereby creating space for the fluid in the reservoir  38 . The migration of the piston  32  out of the reservoir  38  is restricted by the pin  34 , which at one point  36  of the reservoir  38  abuts against its walling and thereby stops the travel of the piston  32  out of the reservoir  38 .  
         [0076]      FIG. 4   b  shows, as in  FIG. 2   b , that the piston  32  in the reservoir  38  can be shifted into a second position, whereby the fluid present in the reservoir  38  is displaced into the dilatable element  44  via the opening  46 , thus bringing the dilatable element  44  into an expanded state to form a tight seal at the point  26  on the annular constriction of the cavity  12 , interrupting the bloodstream in the cavity  12 . Insertion of the piston  32  into the reservoir  38  is thus limited by the pin  34  striking against a second point  37  of the reservoir  38  walling.  
         [0077]     The piston  32 , or insertion thereof, is thus controlled as in  FIG. 2  via a second fluid, which is fed in and out via the opening  39 .  
         [0078]     By returning the piston  32  to its starting position, the first fluid is returned from the dilatable element  44  into the reservoir  38  via the opening  46  by the negative pressure arising.  
         [0079]      FIG. 5   a  shows a further embodiment of the device according to the invention  60 , whereby those elements that are common with the elements of the embodiment from  FIG. 1   a ,  1   b ,  2   a  and  2   b  are designated by the same reference marks.  
         [0080]     In  FIG. 5   a ,  60  as a whole denotes a device for interrupting a bloodstream flowing through a cavity  12 . The device  60  displays an initial dilatable element  14  in the form of a balloon, which in  FIG. 1   a  is in the non-dilated state. The element displays an opening  16  via which it is fluidly connected with a reservoir  18 . Through the reservoir extends a membrane  62 , spatially dividing the reservoir  18  into a first part  64  and a second part  65 . The first part  64  is—directly—fluidly connected with the dilatable element  14  via the opening  16 . The second part  65  is fluidly connected with the second fluid.  
         [0081]     As in  FIG. 5   a  the membrane  62  is in a first position whenever the dilatable element  14  is in the non-dilated state. In  FIG. 5   a  this is shown by slight vaulting of the membrane  62  in the direction of the second part of the reservoir. The first part contains a specific amount of the first fluid. Small quantities of the first fluid may also be located in the dilatable element  14 , without putting it in a dilated state, however.  
         [0082]     In the device  60  in  FIG. 5   a  an annular (cross-sectional) constriction in the cavity  12  is once again characterized by the reference sign  26 , with which the dilated element  14  forms a tight seal.  
         [0083]     In  FIG. 5   b  the dilatable element  14  is in the dilated state.  
         [0084]     Operation of the device according to the invention  60  is such that if the blood-stream is to be interrupted—e.g. on account of the ingress of gas—a second fluid is fed into the reservoir  18  via the opening  66 , or alternatively into the second part  65  of the reservoir  18 . By means of the second fluid, pressure is exerted on the membrane  62 , which in turn transmits this pressure onto the first fluid present in the first part  64  on account of its elasticity. In the process, this in turn is forced out of the first part  64  of the reservoir  18  via the opening  16  into the dilatable element  14 , causing the latter to dilate. The dilatable element  14  forms a tight seal against the circulating annular projection  26 , thereby sealing off the cavity  12 . The fluid flow, or interruption thereof, respectively, in the device  60  is indicated in  FIG. 5   a  and  5   b  with arrows.  
         [0085]      FIG. 5   b  shows the membrane arching into the first part  64  following the introduction of the second fluid into the second part  65  of the reservoir  18 , whereby the volume of fluid in the first part  64  of the reservoir  18 , as mentioned, is displaced into the dilatable element  14 . Siphoning the second fluid out of the reservoir  18 , or alternatively the second reservoir  18 , “relieves” the membrane and returns it to its initial position. In the first fluid is conveyed out of the dilatable element  14  by negative pressure, the being put into a non-dilated state.