HK1158996B - Device for opening a line - Google Patents

Description

The present invention relates to a device for opening a line, in particular a line of a blood tube or blood bag system, where the line has a closing element to prevent the passage of the line, where the device has at least one opening device designed to exert an external force on the line, compressing the closing element and opening the line.

A device for opening a line is known, for example, from DE 10 2005 019 855 A1. The opening device described therein consists of two tubes which are connected by machine or by hand, compressing the section of the line between the tubes and plastically deforming the closing element so that a free flowing cross-section is created in the line and remains free even after the opening device is applied.

Clinic and blood bank staff often have to process a relatively large number of blood bag sets to separate blood into its components in a separator and store these parts in separate containers. This places a relatively high demand on staff, particularly as continuous opening of standard sterile closures involves a high amount of force and can cause pain to staff in the long run.

Finally, there is a risk of malfunction and of the sterile closures not being accidentally or only partially opened or showing sharp points, especially if they are present, and of damage to the blood components by haemolysis.

There is therefore a need to simplify and speed up the procedures while meeting high safety and quality standards, in particular for the opening of sterile closures as defined in DE 10 2005 019 855 A1.

It is important that the opening device for opening the closing element works in the shortest possible time and with the best possible precision, ensuring a quick and easy operation, in particular when the device is operated by hand, so as to achieve a high level of user acceptance.

WO 2004/058046 A2 is a blood-processing device incorporating a device for opening sterile closures in blood vessels. This opening device is axially movable and additionally rotatable. It is used to open a sterile closure with a break cone. As described above, such sterile closures are unfavourable in that they may occasionally produce sharp edges and fragments of the sterile closure which may lead to damage to the blood components. A further disadvantage of the device described in WO 2004/058046 A2 is that the mechanism described is comparatively simple, since a constant back and forth actuator must be operated. This also requires a temporary adjustment.

The EP 1 294 061 B1 is a battery operated, hydraulically operated, hand-operated press, which is of a comparatively complex design, and is comparatively difficult and not as fast to operate as is required to open sterile closures in blood vessel or blood tube systems with high precision and speed.

The same applies to the electro-hydraulic hand tool described in WO 03/084719 A2 for compressing tubular objects and cable shoes.

Finally, a tool for pressing casings, cable shoes or similar is known from EP 0 106 182 B1.

The present invention is intended to develop a device of the type described at the outset which allows the opening of sterile closures, as described in DE 10 2005 019 855 A1, in a short time and with high accuracy.

This task is solved by a device with the characteristics of claim 1.

It is foreseen that the opening device shall be so designed that the line can be inserted only in such a way that the force acting on the line is exerted exclusively or at least also in the area where the locking element is located. The line or the section of line containing the locking element may therefore only be inserted in the opening device in such a way that the pressure exerted from the outside on the line acts at a predetermined point and the line is opened. There is therefore, in accordance with a key-to-key principle, an interaction between the opening unit and the line section in question which prevents a certain section from being inserted in the opening device in such a way that the opening element cannot be prevented from opening, but does not prevent the opening of the line.

The correct insertion of the section or line into the opening device is thus aided by the so-called key-lock principle. In a preferred design of the invention, a further device is provided which prevents only partial insertion of the line. The user of the device may thus be assisted in preventing the opening device from being actuated even though the line is only partially inserted into the opening device. For example, these devices may have a spring-operated conductor designed to push the line either out of the opening device or into the correct opening position. This spring-operated conductor is either not properly inserted or is not in the correct opening position or is placed in the correct opening position.

It can be expected that the opening device is designed in such a way that, in the event of an error, if the line is misplaced and the opening procedure is nevertheless initiated, the closing element is not so severely damaged that the sterility of the products is compromised, for example, the opening procedure can be interrupted in time or the closing element can be deformed only slightly so that the line remains closed and thus the sterility of the blood products is maintained.

The invention further specifies that the device or opening device shall have at least one sensor designed to detect the presence of the line in the opening device and/or its position in the opening device and/or at least one characteristic parameter for the opening operation of the locking device, such as force, torque, motor current or the like, which may be used when the locking device is opened.

The present invention may be implemented in the form of a hand tool, i.e. a hand-held device. Preferably, this hand-held device is used in processes in which the operation of blood bag systems for cell separation or other blood treatment is at least partially manual. However, the invention is not limited to this, but includes, for example, blood processing machines that are formed by the device of the invention or whose component is the device of the invention. These blood processing machines may be designed to use largely automatic processes for cell separation or other blood treatment. It may be planned that the opening of the process element will also be automated or initiated within a specified time.

Where the tool is a handheld device, it may be provided that it is connected to the device's processor unit by a wired or wireless communication link, which may be used, for example, to display information on the handheld device, such as a user guide indicating which locking device to open at which time by means of the handheld device. In this case, the hand tool is particularly easy and fast to use, as the user is shown, for example, on a display or by an acoustic or other means, which locking device or locking elements to open.

The processor may be located, for example, in a blood processing machine and the sensor (s) in the handheld device.

However, as shown above, the invention is not limited to hand-held devices, but also includes the case where at least one opening device is part of a larger unit, in particular a blood processing machine.

As shown, the device may be a blood treatment device, in particular a cell separation device, but the invention is not limited to that.

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Further details and advantages of the invention are explained in more detail by an example of the design shown in the figure. Figure 1:a perspective representation of a part of a blood treatment facility with an opening device,Figure 2:an opening device in perspective representation in composite state and in an explosion representation,Figure 3,4:a handheld device for opening sterile closures in perspective representation and in cut state,Figure 5,6:Details of the backlighting and the rotary body of the facility as shown in Figure 1, 2,Figure 7 - 12:Details of the backlighting and the rotary body with an opening,Figure 13 - 18:Different views and contour representations of the backlighting of the facility as shown in Figure 3,4.

Figure 1 shows in perspective a part 100 of a blood treatment device for cell separation, which has an opening device 10 on its front side to open a closing element, as described in detail in DE 10 2005 019 855 A1.

The opening device 10 is activated by an unspecified processing unit of the apparatus at specified times to compress the closing element and thereby open the line.

Figure 2a shows the opening device 10 in a magnified perspective, Figure 2b shows the arrangement in an explosion depiction. The reference symbol 12 indicates the housing of the arrangement. The reference symbol 14 indicates the two jointed elements of a mechanism that prevents the tube section from being only partially inserted into the opening device 10 shown. As shown in Figure 2b, the two tubes 14 are loaded by springs 19. These spring-loaded tubes 14 cause a tube to be either fully inserted into the arrangement or re-expressed if it has been inserted only in a sharp way. The actual jointed elements of the tube section 14 are either pressed in or not pressed out, provided that they are only pressed out horizontally. The actual jointed elements of the tubes 14 are exposed to the outside of the opening and are not confined by the area behind the opening.

The correct insertion of the line section into the opening device 10 to open the locking element can thus be assisted by a mechanism, as shown in Figure 2b in the form of the spring-loaded beams 14.

The opening device 10 described in Figure 1.2 operates on the principle of the pin. It may have a stretched or angled drive. The opening device 10 is designed in such a way that the locking elements or the sections of the line containing them can only be inserted by pressing them at the predetermined point and thus opening the lines. This key-lock principle prevents the insertion of sections of the line in which no such locking element is located. This would result in the opening device being operated but the line not being opened.

The opening devices 10 are also connected to a processor unit which receives information from a sensor in the opening device 10 that a line segment containing a locking element has been inserted and is in the correct position. This processor unit monitors its correct course during the opening process, which may be done, for example, by means of force measurement, torque monitoring or motor current measurement. In the case of incorrectly inserted or missing line segment or locking element or in the case of a locking element not properly opened, the processor unit may, for example, interrupt, interrupt or trigger an indication or alarm.

The opening device of the invention may be combined with an aid for opening standard closures (reference 18 in Figure 2b) which are opened by bending, and may be so designed as not to impede the use of conventional blood bag systems but to be supported by the said refractive aid.

Figures 3 to 18 show a handheld device 20 for opening closing elements, as known from DE 10 2005 019 855 A1.

As shown in Figures 3 and 4, the handheld device has a rod-shaped shape. It has a battery or battery 22 which drives a DC motor 24. When the motor 24 is operated, the rotor body 28 is driven by the gear 26 connected to the motor 24, i.e. it is put into a rotational motion. The rotor body 28 has axles in its diametrically opposite areas on which rotating wheels 29 are arranged. This is shown, for example, in the detailed diagrams of Figures 5 and 6.

If the rotor body 28 is actuated by the engine 24 or by the transmission 26, the wheels 29 roll off on the surface of the backrest 30 leading to an axial protrusion or entry movement of the opening element 40. Figures 7 to 9 show the opening element in the inserted position. If a sterile closure is opened, the corresponding line section is inserted into the hooked end area 50 of the device 20 and then, by means of a key action by the user, the opening element 40 is removed, so that the closing element is extended and thus the leaf opens. The reversal of the opening element's movement by the springs acts, in particular, on the figure 7 and 12 by the release of the oil in the hooked end section and its release.

It is conceivable that the device described in Figure 3.4 may have a sensor which automatically detects that the line has been inserted correctly and initiates the opening operation automatically, or that the user may be induced by a user guide to cause the opening element 40 to exit by pressing a button or a switch.

The device described in Figure 3.4 may, for example, be wired or wirelessly connected to the blood treatment apparatus and receive signals from it; the communication between these two units may also be bidirectional, for example by transmitting data indicating that the opening has been completed.

Figures 13 to 18 show different perspectives of the back-end guide 30 and its contour lines. The back-end guide 30 is essentially made as a hollow cylinder section and has, in an end-point, the front-facing guide 32 on which the wheels or gliders or the like run, which are put into a rotational motion by the drive unit. The contour of the surface 32 of the back-end guide 30 is designed in such a way that it does not have a constant inclination but requires a near-constant torque to apply the force constantly increasing to a maximum value to open the locking element.

Claims (7)

1. Device for opening a line, in particular the line of a blood tube system or blood bag system, wherein the line is a tube in which a sealing element is located that blocks the passage through the line, wherein the device has at least one opening mechanism, which is designed in such a way that it exerts a force that acts on the line from the outside, as a result of which the sealing element is compressed and the line is opened, characterized in that the opening mechanism is contoured in such a way that the line can be introduced into the opening mechanism only in such a way that the force acting on the line is exerted exclusively, or at least also, in the area in which the sealing element is located.
2. Device according to Claim 1, characterized in that the device further comprises means that prevent an only partial introduction of the line into the opening mechanism, wherein the means preferably comprise a spring mechanism, which is designed in such a way that the line is either pressed out of the opening mechanism or pressed into the correct position in the opening mechanism.
3. Device according to one of the preceding claims, characterized in that the device or the opening mechanism has at least one sensor, which is designed in such a way that it detects the presence of the line in the opening mechanism and/or the position of the line in the opening mechanism and/or at least one parameter characteristic for the opening procedure of the sealing element.
4. Device according to one of the preceding claims, characterized in that the opening mechanism is a component of a hand-held mechanism.
5. Device according to Claim 4, characterized in that the hand-held device has means which are designed in such a way that they signal to the user of the hand-held devices that an opening procedure of a sealing element should be carried out.
6. Device according to one of the preceding claims, characterized in that the device is a blood treatment appliance or a component of a blood treatment appliance.
7. Use of a device according to one of the preceding claims for opening a tube, in particular a tube of a blood tube system or blood bag system, in which a sealing element is located.