METHOD FOR DISCONNECTION
20230218879 · 2023-07-13
Assignee
Inventors
Cpc classification
A61M2039/1016
HUMAN NECESSITIES
A61M1/36222
HUMAN NECESSITIES
A61M60/113
HUMAN NECESSITIES
International classification
A61M60/113
HUMAN NECESSITIES
A61M1/36
HUMAN NECESSITIES
Abstract
The present invention relates to a method for disconnecting two fluid-conducting line sections of a medical device which are detachably interconnected, wherein a first line section of the two line sections has at least partially an elastic property. The method comprises the steps of enclosing a fluid volume in the two line sections, generating a reduced pressure in the two line sections, as a result of which elastic deformation from a starting position into a tensioned position takes place in and/or on the first line section, wherein a fluid volume contained in the first line section is lower in the tensioned position than a fluid volume contained in the starting position, and detaching the connection of the line sections, wherein the fluid volume contained in the first line section in the tensioned position increases. Furthermore, the invention relates to a medical device which is configured to carry out a method of this kind.
Claims
1. Method for disconnecting two fluid-conducting line sections of a medical device, in particular a medical device according to claim 7, which are detachably interconnected, wherein a first line section of the two line sections has at least partially an elastic property, comprising the steps of: enclosing a fluid volume in the two line sections, generating a reduced pressure in the two line sections, as a result of which elastic deformation from a starting position into a tensioned position takes place in and/or on the first line section, wherein a fluid volume contained in the first line section is lower in the tensioned position than a fluid volume contained in the starting position, and detaching the connection of the line sections, wherein the fluid volume contained in the first line section in the tensioned position increases.
2. Method according to claim 1, wherein the first line section comprises at least one region which is more elastic than the second line section.
3. Method according to claim 1, wherein the first line section and the second line section comprise at least one region which is more elastic than the remainder of the first line section and the second line section.
4. Method according to claim 1, wherein the elastic property is provided by an elastic material and/or a geometry having elastic restoring force and/or an enclosed gas.
5. Method according to claim 1, wherein the first line section is part of a device-side fluidic system, in particular of the medical device, and the second line section is part of a disposable item, or the second line section is part of a device-side fluidic system, in particular of the medical device, and the first line section is part of a disposable item.
6. Method according to claim 1, wherein there is substantially only a physiological fluid and no blood in the first and the second line section.
7. Medical device, configured to receive at least two fluid-conducting line sections that can be detached from one another, wherein a first line section of the two fluid-conducting line sections has at least partially an elastic property, comprising at least a first and a second shut-off element for enclosing a fluid volume in the two line sections, a pump for generating a reduced pressure in the two line sections, as a result of which elastic deformation from a starting position into a tensioned position takes place in and/or on the first line section, a controller for actuating the pump, wherein the controller is programmed to operate the pump to generate the reduced pressure in a disconnection mode.
8. Medical device according to claim 7, wherein the controller is programmed to close one of the shut-off elements before generating the reduced pressure, to close the fluid volume on one side and/or to close one of the shut-off elements for enclosing the fluid volume after generating the reduced pressure.
9. Medical device according to claim 7, comprising the first or the second line section, wherein this line section is part of a device-side fluidic system of the medical device.
10. Medical device according to claim 9, comprising a fluid source, in particular a fluid source for a physiological liquid, fluidically connected to the second line section, optionally, a sterile filter fluidically arranged between and connected to the fluid source and the second line section, and a medical-device-side connector on one end of the second line section for connection to one end of the first line section.
11. Medical device according to claim 9, comprising discharge line, wherein the first line section is fluidically connected to the discharge line or is part thereof, a medical-device-side connector on one end of the first line section for connection to one end of the second line section.
12. Medical device according to claim 7, wherein the pump is a peristaltic pump and at least one actuator of the peristaltic pump is part of the first or second shut-off element or is the first or second shut-off element.
13. Medical device according to claim 7, wherein the pump is an ultrafiltration pump and/or a blood pump and/or a substituate pump of an extracorporeal blood-treatment machine, in particular a dialysis machine.
14. Medical device according to claim 7, comprising a user interface for a user to input an instruction, wherein the controller is programmed to activate the disconnection mode or to start the pump in response to the instruction being input on the user interface, and/or wherein the controller is programmed to activate a plurality of modes and to automatically switch from one of the modes into the disconnection mode.
15. Medical devices according to claim 9, comprising the other line section of the two line sections, wherein the first line section has at least partially an elastic property, wherein a fluid volume contained in the first line section is lower in the tensioned position than a fluid volume contained in the starting position, and wherein, optionally, the other line section of the two line sections is part of a disposable item, in particular a tube set or cassette system used as part of blood treatment, or, optionally, both line sections are part of one or more disposable items, in particular a tube set or cassette system used as part of blood treatment.
16. Medical devices according to claim 15, wherein the first line section comprises at least one region which is more elastic than the second line section.
17. Medical devices according to, claim 15 wherein the first line section and the second line section comprise at least one region which is more elastic than the remainder of the first line section and the second line section.
Description
[0076] Other features and effects of the present invention become apparent from the following description of selected embodiments of the invention with reference to the appended drawings, in which identical or similar components are denoted by the same reference signs. The features described in the following can be implemented in embodiments that are described above. These embodiments described above are not all set out again in the following. In the drawings:
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[0090] When using the method according to the invention, an embodiment of the medical device 1, which is schematically shown in
[0091] The shut-off elements 7, 8 can be closed and a fluid volume can be enclosed in the two line sections 2, 3 as a result. The shut-off elements 7, 8 can be closed in succession or simultaneously, and in particular a first shut-off element can be closed, then the reduced pressure can be generated, and then the second shut-off element can be closed.
[0092] The connection of the line sections 2, 3 can then be detached, wherein the fluid volume contained in the first line section 2 increases compared with the fluid volume in the tensioned position.
[0093] The method will be explained on the basis of elastic mechanical deformation with reference to
[0094] If the shut-off element 8 is closed at the end of the second line section and the pump 6 pumps fluid or liquid from the first line section 2 towards the second shut-off element 7 (open), reduced pressure is generated at least in a part of the first line section 2. In this process, the volume of the first line section 2 can deform, for example contract inwards (see the arrows in
[0095] In other words, the walls of the line section 2 thus leave the starting position, which is shown by a schematic dashed line in
[0096] If the two line sections 2, 3 are detached from one another, the elastically deformable region relaxes owing to the elastic property and the first line section 2 returns towards the starting position from the tensioned position. As shown in
[0097] Before disconnecting the first line section from the second line section, there may be liquid or a liquid column in the connection region. Without the suction effect due to the relaxation, the liquid column could simply separate and the liquid would flow downwards out of the connection region, at least due to gravity.
[0098] In the case described here, when detaching the first line section from the second line section 2, 3, due to the relaxation in the first line section 2, the air can be drawn from the outside inwards in the disconnection region and the fluid column can likewise at least partially follow the suction effect. As a result, more liquid can remain in the first line section 2 overall during the disconnection and a directed flow of the liquid into the first line section 2 can also be achieved.
[0099] The risk of contamination of the second line section 2 and/or a leak (escape of liquid to the outside) can thus be reduced.
[0100] The medical device 1 may comprise a controller 9. The controller 9 may be programmed to operate the pump to generate the reduced pressure in a disconnection mode. Optionally, the controller 9 may also be programmed to actuate at least one or both shut-off elements 7, 8. For this purpose, the controller can be connected to the respective components to be actuated (pump 6, shut-off elements 7, 8, for example) via signal lines 10, 11, 12 of the medical device 1. The controller 9 may be programmed to start and/or stop the pump 6, for example.
[0101] For example, the controller may be programmed to start the pump 6 when the first valve 7 is closed or the valve 8 is closed and to close the other valve 7, 8 such that an enclosed volume is produced in which reduced pressure is applied or the deformable region has deformed.
[0102] The medical device 1 may comprise a user interface 13. The user interface 13 may be configured for a user to input an instruction and the controller 9 may be programmed to activate the disconnection mode in response to the instruction being input on the user interface 13.
[0103] The line sections 2, 3 are not necessarily both part of the medical device 1, but instead one or both of the line sections 2, 3 can be connected to the pump 6 and the shut-off elements 7, 8 only when the medical device 1 is being used.
[0104] The medical device 1 may comprise the first line section 2 and/or the second line section 3. The first line section 2 and/or the second line section 3 may be part of a device-side fluidic system of the medical device 1.
[0105] The first line section 2 and/or the second line section 3 may be part of a disposable item.
[0106] The pump 6 may be arranged along the first line section 2 and/or the second line section 3 or a point in the fluidic system outside the two line sections 2, 3 which is fluidically connected to the two line sections 2, 3. For example, the pump 6 may be arranged on the side of the shut-off elements 7, 8 arranged on the far side of the connectors 3, 4. The pump 6 only needs to be able to remove liquid from the elastically deformable region.
[0107] The medical device 1 may comprise an automatic disconnection device 14. This automatic disconnection device 14 may, for example, comprise a motor which moves the first and/or the second line section 2, 3 and therefore detaches the connection between the first and the second line section 2, 3. The controller 9 may be programmed to actuate the automatic disconnection device 14. This can make it possible for the hygienic disconnection method to be carried out fully automatically, i.e. without human intervention.
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[0109] The pump 6 may be a peristaltic pump and an actuator 15 may be engaged with the first tube section 2 in the region of a line loop 16. As a result, the closed fluid volume can be formed.
[0110] In this example, the pump 6 is a roller pump (an embodiment of a peristaltic pump) and the line loop 16 is inserted into the pump 6.
[0111] Before disconnecting the line sections 1 and 2, the rollers of the pump 6 are moved into a predetermined disconnection position such that at least part of the line loop 16 is within the second section (between the connection point and the fluidic shut-off point of the pump 6), and remain in this closing configuration during the disconnection. In this example, the pump 6 acts as the shut-off element on the side of the first line section 2. On the device side, the valve 8 acts as the shut-off element. The pump 6 also serves to generate the reduced pressure in the interconnected line sections 1 and 2.
[0112] The rollers of the pump 6 perform at least one rotation by a predetermined angle to generate reduced pressure. If the position of the rollers at the start of the process is such that the angle is no longer large enough, two rollers can additionally be rotated by a full revolution or a half revolution. The rotation can also take place until a predetermined reduced pressure is reached.
[0113] A pressure sensor 17 may be provided in the medical device 1, which measures the pressure in the enclosed volume and, if necessary, in cooperation with the user interface 13, displays the pressure or displays whether the reduced pressure is sufficient, and/or the controller 9 displays that the pump 6 needs to be rotated further.
[0114] The controller may be programmed to actuate the pump accordingly.
[0115] When detaching the first line section from the second line section 1, 2, the second line section 2 or the region 16 thereof moves back into the starting position and fluid is drawn into the second line section 2 or the region 16 thereof.
[0116] As shown in
[0117] By means of the pump 6, fluid, in particular liquid, is conveyed through the non-return valve 8, as a result of which the first line section 2, in particular the region 16 thereof, is brought into a tensioned position. In this embodiment, the enclosed volume can already be present before the pump is started. When the pump is operated, fluid is removed from the region of the first and/or second line section 2, 3.
[0118] Various types of pump can be used in this embodiment, for example, since occluding properties are not required for enclosing the fluid volume in this example; e.g. a peristaltic pump 6 comprising retractable actuators, a gear pump, impeller pump, centrifugal pump or membrane pump can be used.
[0119] The non-return valve may also be present in the embodiment described in conjunction with
[0120] The level of the generated reduced pressure can be set by a predetermined number of pump revolutions/actuations of the fingers of a finger pump or by means of a predetermined reduced pressure. This control or monitoring can be carried out by the controller 9.
[0121] When detaching the first and the second line sections 1 and 2, the second line section 2 or the region 16 thereof moves back into the starting position and fluid is drawn into the second line section 2 or the region 16 thereof.
[0122] The medical device 1, as schematically shown in
[0123] In an arrangement of this kind, fluid can be drawn towards the first line section 2 as part of one of the device-side hydraulics 18. This arrangement may be used if a liquid-filled tube set, for example after priming, which is at least partially formed by the second line section 3 is intended to be removed from the first line section 1 and is then intended to be connected to a patient. As a result, the second line section 3 may potentially be kept in a more hygienic state.
[0124] The medical device 1 may comprise a shut-off means 20. The shut-off means 20 can be opened or the controller 9 can be programmed to open said means before the reduced pressure is generated. As a result, the volume in which the reduced pressure acts can be increased (by the additional volume of the hydraulics 18), or the fluid volume of the first line section 2 can be increased and/or the gas reservoir can be part of the first line section 2. This may give the first line section 2 a more elastic property than if the shut-off element 20 were closed. Therefore, it is possible to enhance the effect of the relaxation out of the tensioned position.
[0125] The device-side hydraulics 18 may comprise a region made of an elastic material. The region can be moved into a tensioned position by the generated reduced pressure.
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[0127] The pump 6 may be a blood pump of a blood-treatment machine. The blood pump may be configured to pump blood in a blood line 21 during blood treatment. The first line section 2 may be a liquid-supply line. During treatment, liquid can be transferred into the blood line 21 from the first line section 2.
[0128] The line section 2 or at least a region thereof can be brought into a tensioned position by the reduced pressure generated by means of the pump 6 arranged outside, such that fluid is drawn into the second line section 2 when the line sections 2 and 3 are detached.
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[0131] The configuration as described in conjunction with
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[0133] The dialysis machine in the form of the medical device 1 comprises or may comprise the following components:
[0134] A liquid source 26, a balancing system comprising a pump 27, a first sterile filter 28 (optional), a second sterile filter 29 (optional), a dialyzer 30 (optional), a ventilation chamber 19 (optional), an ultrafiltration pump 6′ (optional), a priming or substituate port 5, a priming or substituate pump 6 (optional), a discharge port 4′, a blood pump 31, a controller 9, a user interface 13, signal lines 10, 11, 12 (only a selection shown), a venous clamp 8′, an arterial clamp 32 (optional), a pre-dialyzer shut-off element 36 (optional), a post-dialyzer shut-off element 37 (optional), a first discharge-line shut-off element 7′ (optional), a first priming-line shut-off element 8, a second priming-line shut-off element 7, a discharge shut-off element 20 (optional), and a T-piece or Y-piece 24 (optional).
[0135] The components may be connected to liquid-conducting lines as follows: The liquid, generally a physiological liquid or dialysate, is pumped from the liquid source 26 into a dialysate line 33 through the balancing system 27, optionally through the first sterile filter 28, to the dialyzer 30, and is then discarded from the dialyzer 30 in a discharge line 34, optionally through a ventilation chamber 19, again through the balancing system 27 into a discharge 35 (not part of the medical device 1). The dialysate line 33 may comprise a branch line, in the form of a second line section 3, for example optionally via a second sterile filter 29, which can be guided via a priming or substituate port 5 to a priming or substituate line, in the form of a second line section 2. This priming or substituate line 2 may be connected to an arterial blood line 22 or a venous blood line 23. Liquid, e.g. blood during the treatment or priming or flushing liquid in the priming phase, can be pumped by means of a blood pump 31 in the blood line(s) 22, 23. The balancing system ensures that only a predetermined quantity of liquid is removed from the patient. Various balancing systems are known, for example the quantity of liquid that is pumped to the patient and the quantity that is pumped away from the patient can be determined by flow measurement and the delta, as prescribed, can be set such that a desired ultrafiltration rate, in other words a net balance rate, is implemented. Another balancing system is shown in
[0136] In addition, the medical device 1 may also comprise a series of shut-off elements. For example, the device 1 may comprise a venous shut-off element 8′ (venous clamp), an arterial shut-off element 32 (arterial clamp), a pre-dialyzer shut-off element 36, a post-dialyzer shut-off element 37, a first discharge-line shut-off element 7′ and a first and second priming-line shut-off element 7, 8.
[0137] The difference between the embodiments shown in
[0138] The following components or lines may in particular be designed as disposable items: the dialyzer 30, the arterial blood line 22, the venous blood line 23, or the priming or substituate line 2. These lines can together form a tube set or cassette system. A cassette system means that at least two of these lines are detachably interconnected and/or the lines are at least partially formed by flexible tubes, and otherwise by dimensionally stable channels.
[0139] The medical device 1 may for example be configured to fill the tube set or cassette system with physiological liquid before the treatment. For this purpose, the controller 9 may for example be programmed to transfer liquid from the liquid source 26 into the tube set or cassette system via the priming or substituate port 4 by means of the pumps of the balancing system 27, for example in a filling mode, which can also be called a priming mode. In another method step, for example a flushing mode, the tube set or cassette system can be flushed after filling, wherein liquid is flushed through the tube set or cassette system and is flushed through the discharge port 4′ into the discharge line 34. For the treatment, the venous line 23 must be connected to the patient. For this purpose, for example in the embodiment in
[0140] It should be noted at this point that the medical devices 1 as described in conjunction with
[0141] The medical device 1 may also be configured for a disconnection step after the treatment. For this purpose, the controller 9 can close the shut-off element 8 and operate the pump 6. The pump 6 may be a peristaltic pump in the form of a substituate pump. Alternatively, the blood pump 31 can also be used to generate reduced pressure in the line section 2 or to pump liquid out of said line section. The shut-off element 7 may be a non-return valve and may also be part of a transition piece or part of the arterial tube 22, and therefore it is not necessary to actively close this shut-off element.
[0142] In other configurations of the shut-off element 7, the controller may be programmed to close the shut-off element 7 after operation of the pump 6. Owing to the elastic property of the first line section 2, at least part of the first line section 2 deforms into a tensioned position. The first line section 2 may also be more elastic than the second line section 3. When subsequently detaching the second line section 3 from the priming or substituate port 5, which is optionally carried out manually or automatically, the first line section 2 can relax.
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[0144] Where reference is made to an embodiment here, this should be understood to be a purely exemplary embodiment according to the invention.
[0145] Embodiments according to the invention may have one or more of the above-mentioned features in any combination, provided that the specific embodiment does not appear to be technically impossible to a person skilled in the art.