device for detecting moisture and process for producing said device, device for monitoring access to

专利摘要:
DEVICE TO DETECT HUMIDITY TO USE WITH A DEVICE TO MONITOR ACCESS TO A PATIENT. The invention relates to a device (40) for detecting moisture for use with a device B for monitoring access to a patient for equipment, with which, through a conductive tube, fluid is supplied to a patient and / or a fluid is removed from the patient especially for a device for the treatment of extracopeal blood A. The device according to the invention to detect moisture is formed as a flat structure to be placed on the patient's skin which, as a humidity sensor, presents an electrically conductive structure. The device stands out for the fact that the flat structure is a flat textile structure, which is formed of both non-conductive warp and weft threads, as well as conductive warp and weft threads, as well as warp and weft threads conductors (50.60). The conductive and non-conductive warp and weft threads are arranged in such a way that the electrically conductive structure is produced. Through spatial separation of the warp and weft threads, a defined electrically conductive structure is produced in the fabric. A decisive advantage of (...).
公开号:BR112012023970B1
申请号:R112012023970-8
申请日:2011-03-23
公开日:2020-11-10
发明作者:John Heppe
申请人:Fresenius Medical Care Deutschland Gmbh；
IPC主号:

专利说明:

[001] The invention relates to a device for detecting moisture for use with a device to monitor access to a patient for equipment, with which, through a conductive tube, a fluid is supplied to a patient and / or a fluid is drawn from the patient especially to monitor vascular access in an extracorporeal blood treatment, in which a patient's blood is drawn through an arterial conductive tube, which has an arterial cannula and through a venous conductive tube, which has a venipuncture cannula is provided to the patient. In addition, the invention relates to a device for monitoring access to a patient, which has a device for detecting moisture. In addition, the invention relates to a device for treating blood with an extracorporeal blood circulation, which features an arterial conductive tube with an arterial cannula and a venous conducting tube with a venous cannula, in which the extracorporeal blood treatment device it has a device to monitor arterial and / or venous vascular access. The invention also relates to a process for producing devices for detecting moisture for connection to a device for monitoring access to a patient.
[002] In the field of medical technology, several devices are known, with which, through a conductive tube, it is possible to withdraw fluids from patients or supply fluids to patients. In this case, access to patients is usually performed with a catheter to introduce into organs of the body or with a cannula to puncture vessels. During the examination or treatment, adequate access to the patient must be ensured. Therefore, it is necessary to monitor access to the patient.
[003] Extracorporeal blood treatment devices, which have an extracorporeal blood circulation, also particularly require adequate access to the patient. Known extracorporeal blood treatment devices include, for example, dialysis devices and cell separators, which make access to the patient's vascular system necessary. In the treatment of extracorporeal blood, blood is drawn from the patient through an arterial conductive tube with an arterial puncture cannula, which is again supplied to the patient through a venous conducting tube with a venipuncture cannula.
[004] Despite the regular monitoring of vascular access by nurses, there is fundamentally the danger that the puncture cannula will escape imperceptibly from the patient's blood vessel. There is also a danger of imperceptible exit from the puncture cannula in domestic dialysis. To monitor vascular access, several devices of different structure are known. The known monitoring devices use, in general, the safety devices present as a standard feature in blood treatment devices, which in a vascular access not according to the regulation, cause an immediate interruption of extracorporeal blood circulation.
[005] Devices for monitoring vascular access are known, which have a device for detecting moisture, in order to be able to recognize the outflow of blood at the puncture point. Known devices for detecting moisture, which are used in monitoring devices known for patient access, are formed as a plug to be placed at the puncture point. The plug consists of an absorbent material, to which a humidity sensor is attached.
[006] WO 2006/008866 A1, US 2005/0038325 and US 6,445,304 BI describe devices for detecting moisture from an absorbent material, which is placed on the skin. The known plugs stand out for the fact that the humidity sensor is fitted to the absorbent material.
[007] From EP 1,537,264 BI an electrically conductive wire and an electrically conductive wire fabric are known. This fabric must be used for shielding electromagnetic fields or for dissipating static charges. The fabric must also be used for data transfer and current supply. Another purpose of using the electrically conductive wire is seen in the manufacture of expansion and humidity sensors.
[008] A nonwoven of synthetic fibers for shielding against sources of electromagnetic interference is described in DE 197 12 043 A1. In addition, fabrics consisting of several layers are known, in which some crossing points of warp and weft threads form electrical contact points.
[009] WO 2009/075592 A2 describes a device for detecting moisture in the form of a strip of fabric, on which or in which two parallel conducting paths are provided, among which the electrical resistance is measured. The two conducting pathways are formed by conducting threads, which extend only in the longitudinal direction of the fabric strip. Electrical contact points between intersecting conductive paths are not provided. It is disadvantageous that the humidity sensor, due to the shape of the electrically conductive structure, has only a relatively low sensitivity.
[010] The purpose of the invention is to create a device to detect moisture to be produced economically in large quantities with a high sensitivity, which is easy to handle and offers high comfort of use. Another object of the invention is to create a device for monitoring access to a patient with such a device for detecting moisture and a device for treating extracorporeal blood with such a device for monitoring access to a patient. An object of the invention is also a process for the economical manufacture of devices for detecting moisture in large quantities.
[011] The solution of these objectives is carried out according to the invention, with the characteristics of the independent claims. Advantageous embodiments of the invention are the subject of the subclaims.
[012] The device for detecting moisture according to the invention is intended for connection to a device for monitoring access to a patient. The device according to the invention is formed as a flat structure to be placed on the patient's skin which, as a humidity sensor, has an electrically conductive structure, to which the device can be connected to monitor access to the patient.
[013] The device for detecting moisture according to the invention stands out for the fact that the flat structure to be placed on the patient's skin is a flat textile structure, which is formed from both non-conductive warp and weft threads , as well as conductive warp and weft threads. The conductive and non-conductive warp and weft threads are arranged in such a way that they form the electrically conductive structure. Through the spatial separation of the warp and weft threads, a defined electrically conductive structure is formed in the fabric.
[014] The use of a fabric to produce the device to detect moisture results in decisive advantages in practice. A decisive advantage in using both conductive warp yarns, as well as conductive weft threads, is in being able to form an electrically conductive structure, which has sections that extend in different directions. With such a structure it is possible to produce a humidity sensor, which has a particularly high sensitivity.
[015] The tissue has all the properties, through which the device must be detached to detect moisture to be placed on the patient's skin. These include, in addition to the required biocompatibility, also high air permeability and absorbent power. The device to detect moisture formed as a flat textile structure is soft and flexible and pleasant to use on the skin. With a suitable choice of materials for the warp and weft threads, high biocompatibility can be achieved. Since the electrically conductive structure is a component of the fabric, additional materials for the production of an electrically conductive structure, which could not have the required biocompatibility, are not necessary. In a conventional weaving process, the device for detecting moisture can be produced economically in large quantities.
[016] The production process of the device according to the invention can be carried out with a high degree of automation. In this way, a large number of highly sensitive sensors can be produced economically with a single automatic loom on a fabric strip, where the individual sensors can be separated from the fabric strip during the process or later. For example, an automatic loom on a fabric strip up to 3,000 mm wide can produce up to 2,000 sensors per hour. Research has shown that the sensors produced with the process according to the invention are largely insensitive to the rupture of conductive pathways and have a high resistance to flexural fatigue.
[017] The device for detecting moisture can be formed in different forms. It can be used not only in devices for the treatment of blood, which create a vascular access through a cannula or needle, but, fundamentally, they are also suitable for use in catheters to supply and remove fluids.
[018] In a preferred embodiment of the device for detecting moisture, the electrically conductive structure has a first conductive path and a second conductive path, in which the ends of the two conductive paths are formed as terminal contacts. When the strip of tissue between the two conductive pathways comes into contact with blood, the electrical resistance measured between the two terminal contacts changes. When there is a terminal resistance, an electrical resistance is measured between the terminal contacts, which corresponds to a parallel connection of the terminal resistance and the electrical resistance between the conducting pathways. In this case, it is assumed that the blood connects the adjacent conductive pathways by means of a bridge.
[019] To increase the sensitivity of the humidity sensor, the two conducting pathways are preferably arranged side by side in a plurality of sections. In this case, the sensitivity with an increasing number of sections arranged next to each other increases. Preferably, all the space available on the device to detect moisture should be used for the humidity sensor.
[020] An alternative form of execution provides for only one conductive path, but formed as a closed conductive circuit for the electrically conductive structure, the ends of which are formed as terminal contacts.
[021] This form of execution provides that the conductive path has a defined resistance. The sensitivity of the humidity sensor increases with the increasing number of sections placed next to each other in the closed conductor circuit. If a precisely defined resistance cannot be adjusted in the production process, the resistance, also in the application of the sensor, can be initially measured and used as a reference value. The specific length resistance of a conductive wire can make up, for example, 100 Ohm per meter with a deviation of +/- 10%. But other values are also possible.
[022] From the use of a fabric to produce the device to detect moisture, it follows that the electrically conductive structure is composed of a plurality of electrically conductive sections that extend in a first direction and a plurality of electrically conductive sections that extend in a second direction, the first and second directions being orthogonal to each other. Therefore, one or two conductive pathways can be produced in the fabric that extend in a sinuous or spiral shape.
[023] A particularly preferred embodiment, provides that the flat textile structure is formed at least partially as a multilayered fabric. The multilayer fabric allows, in the weaving process, the electrical contact or insulation of the warp and electrically conductive threads that cross at the connection points in different planes. With this, a particularly safe contact or insulation of the warp and weft threads at the crossing points can be obtained.
[024] A preferred embodiment provides for a fabric with three layers. The three layers of tissue can be found in all points of the sensor or only in some points of the sensor.
[025] In the three-layer fabric, the electrically conductive and electrically non-conductive warp and weft threads can be arranged in such a way that a layer to be placed on the patient's skin, which is not electrically conductive, is formed by a layer, in which the electrically conductive sections of the conductive path are located in the first direction and by a layer, in which the electrically conductive sections of the conductive path are located in the second direction. To create electrical contact points, the electrically conductive warp yarns change the planes in the area of the crossing points of the warp and electrically conductive wires in such a way that the warp and weft threads come into contact at the crossing points. Isolation points are created by the fact that electrically conductive crossed warp and weft threads do not touch the planes due to a partial change.
[026] The individual sections of a conductive path can be fundamentally formed by only one warp thread and electrically conductive weft. But also several electrically conductive warp or weft threads that extend side by side can form the sections of the conductive path. This results in greater redundancy against breakage of the wires.
[027] In the manufacture of the fabric with the electrically conductive structure, the strips can be structured by the fact that the flat textile structure is cut into defined parts, so that a part of electrically conductive warp or weft threads extending side the side can be cut. Preferred embodiments of the invention essentially presuppose annular or cruciform sections in the flat textile structure. However, the sections can also have any other desired shape. They can be located inside or at the edge of the fabric. In this case, the sections can be used not only for the other structuring of the electrically conductive structure, but also for the conduction of the cannula or for fixing the device to detect moisture.
[028] An alternative form of execution of the device to detect moisture, in which the flat textile structure is a multilayer fabric, provides between the layer, in which are the electrically conductive sections of the conductive path that extend in the first direction and the layer, in which are the electrically conductive sections of the conductive path that extend in the second direction, another layer, with which the warp and weft threads in these two planes are electrically isolated from each other.
[029] The flat textile structure can have different sizes. On the one hand, it should be large enough to completely cover the puncture points, on the other hand, it should not be so big, to prevent the puncture. Preferred embodiments presuppose a flat U-shaped or annular textile structure. The U-shaped fabric allows you to place the device to detect moisture even when the cannula has already been placed. The annular tissue preferably has a central section for the passage of the cannula.
[030] Another particularly preferred embodiment includes a flap on the flat textile structure, on which the terminal contacts are arranged.
[031] Another particularly preferred embodiment, provides, that the flat textile structure has a section with a notch and a section with a cover for the notch, in which the electrically conductive structure is formed in such a way that the textile structure flat is sensitive to moisture on the upper side. The advantage of this form of execution is that the notch of the flat textile structure, in which the cannula is placed, can be covered with the cover. For this, the section with the cover is simply folded over the section with the notch. Then, the humidity sensor is sensitive on both sides.
[032] The device according to the invention for monitoring access to a patient, especially for monitoring venous access in an extracorporeal blood treatment, has a device according to the invention for detecting moisture. The monitoring device preferably has an evaluation unit that can be connected to the device to detect moisture, which detects an acoustic and / or optical and / or tactile alarm when it detects moisture. A control signal can also be produced for an intervention in the control of the equipment, with which a fluid can be supplied to the patient and / or a fluid can be removed from the patient through the conductor tube.
[033] The monitoring device preferably has one, to which the device to detect moisture is connected, to produce a connection between the evaluation unit of the monitoring device and the humidity sensor of the device to detect moisture. The connecting part of the monitoring device is electrically connected to the evaluation unit, preferably via a connecting cable of sufficient length. But alternatively, a wireless connection can also be formed.
[034] In the form of execution of the device to detect moisture, which has a conductive path formed as a closed conductive circuit with two union contacts, an input impedance is not provided. In the two-conductor design, two ends of the conductive path are connected with each other via an input impedance and the other ends of the conductive path are electrically connected with the evaluation unit of the monitoring device. The input impedance allows, in the form of execution with the two conducting paths, the examination of the device to detect humidity for its operational capacity through a resistance measurement between the union contacts. In the case of the humidity sensor capable of functioning, a resistance is measured between the union contacts, which corresponds to the sum of the input impedance and the resistance of the conducting path.
[035] In the form of execution with the two conductive paths connected through an input impedance, it is particularly advantageous that the input impedance is not a component of the device for detecting moisture, but a component of the monitoring device. This has the advantage that there is no need to provide an input impedance on the fabric or the fabric. In addition, it is advantageous that the input impedance after changing the device determined for single use to detect moisture is not discarded. It is also advantageous that a separate input impedance can be reproduced more easily than a resistance on or in the fabric. A printed input impedance, for example, is subject to much higher finishing tolerances. The finishing tolerance of, for example, miniature resistors (SMD resistors), on the contrary, can be less than 1% of the theoretical resistance value. It is also advantageous that the resistance value of a separate input impedance, as opposed to a printed resistance, cannot change due to alternating flexing efforts during dialysis treatment.
[036] Since the input impedance is not a component of the device to detect moisture, it is possible to use conventional resistors, especially miniature resistors (SMD resistance), which are economical and have a low tolerance to the component. The input impedance may not change if the device for detecting moisture is exposed to fluids. In addition, in the production of the device to detect moisture, another production step is omitted. In the production of the fabric moisture sensor, no solvents, pastes or the like are needed, which increases biocompatibility.
[037] In a particularly preferred embodiment, the input impedance is located on the connector of the monitoring device. The connecting piece has, in a particularly preferred embodiment, four connecting contacts, the connection cable for the production of an electrical connection being connected between the monitoring device evaluation unit in the first and second connection contact and the device for detecting moisture and the third and fourth connection contact is electrically connected with each other through the input impedance. In this case, the order in which the union contacts are arranged is arbitrary. It just depends on that two power contacts can be connected to a power source and two input contacts can have an input impedance.
[038] The joining piece is preferably formed as a clamping device to clamp the flat textile fabric of the device to detect moisture. The clamping device preferably has means, with which the device for detecting moisture is adjusted and / or fixed, in which the connection contacts of the device for detecting moisture are face to face with the corresponding connection contacts of the connection piece of the device of monitoring. These means may be formed as recesses corresponding to the shape of the device for detecting moisture or as additional parts corresponding to the shape of the notches of the device for detecting moisture. The fixation can be carried out by means of interlocking, adhesion or friction closing. The connection contacts of the connection piece of the monitoring device can also be formed as a means of attachment. For example, union contacts can be punches that penetrate the fabric.
[039] The device according to the invention for monitoring access to a patient can form a separate unit or be a component of the equipment, with which a fluid is supplied to a patient and / or the fluid is removed from the patient, can be especially component of the extracorporeal blood treatment device. When the monitoring device according to the invention is part of the blood treatment device, the monitoring device can make use of certain construction groups or construction parts, which are present in the blood treatment device anyway.
[040] The side of the device for detecting moisture, which is placed on the patient's skin, is preferably covered with a layer of adhesive or moisture impermeable glue for fixing the device to detect moisture on the skin. Preferably, a covering material covering the layer is applied to the adhesive or adhesive layer, which can be easily removed from the support material.
[041] In the production of the device to detect moisture, it has been proven to be advantageous, that in the woven bands, the layer of adhesive or glue in the weaving process together with the covering material, can be continuously easily applied on the flat textile structure. The devices for detecting moisture are present, then, as rollers and only need to be separated from each other. Preferably, the individual devices for detecting moisture are cut or punched to the desired shape directly after the application of the adhesive or glue layer and the covering material.
[042] Instead of the adhesive or glue layer, an adhesive film preferably impermeable to moisture, for example, a PET film, can be applied on the fabric. The adhesive film has, on the one hand, the advantage that a barrier can be created against soaking the tissue with the patient's sweat, on the other hand, a different adhesive force can be provided on the upper and lower sides. Preferably, the film on the side facing the patient's skin has a lower adhesive force than on the side away from the film and facing the tissue.
[043] Below, several examples of carrying out the invention are illustrated in detail with reference to the drawings.
[044] Show:
[045] figure 1 the essential components of a device for treating blood, which has a device for monitoring arterial and venous vascular access,
[046] figure 2 a section through the fabric,
[047] figure 3A is a schematic representation of the first tissue layer of the device to detect moisture,
[048] figure 3B is a schematic representation of the second tissue layer of the device to detect moisture,
[049] Figure 3C is a schematic representation of the device's third tissue layer to detect moisture,
[050] figure 3D a schematic representation of the second and third layer of tissue of the device of figure 3B and figure 3C,
[051] figure 3E is a schematic representation of the first conductive path,
[052] figure 3F is a schematic representation of the second conductive path,
[053] figure 3G is a representation of the conducting pathways of the second and third layers of tissue,
[054] figure 3H is a representation of the electrically conductive continuous warp and weft threads with the conducting pathways of the second and third layers of fabric,
[055] figure 4A shows the first layer of fabric in a second embodiment of the device to detect moisture with another layer of insulating fabric;
[056] figure 4B the second layer of tissue of the device to detect moisture,
[057] figure 4C the third layer of insulating fabric,
[058] figure 4D the fourth layer of tissue,
[059] figure 4E a representation of the electrically conductive warp and weft threads of the second and fourth layers of fabric,
[060] figure 4F is a schematic representation of the first conductive path,
[061] Figure 4G is a schematic representation of the second driving path,
[062] Figure 4H is a representation of the conducting pathways of the second and fourth layers of tissue,
[063] Figure 41 is a representation of the conductive pathways of the second and fourth layers of fabric together with the electrically conductive continuous warp and weft threads,
[064] figure 5A the first layer of fabric from another example of making the device to detect moisture,
[065] figure 5B the second layer of fabric,
[066] figure 5C the third layer of fabric,
[067] figure 5D a representation of the conductive warp and weft threads of the second and third layers of fabric,
[068] figure 5E a representation of the conductive path of the device to detect moisture,
[069] figure 5F a representation of the conductive path together with the continuous warp and weft threads,
[070] figure 5G the conductive path with an isolated tissue area on the upper side,
[071] figure 6 a first example of execution of the connection piece of the device to monitor access to a patient,
[072] figure 7 a second example of execution of the connection piece of the monitoring device,
[073] figure 8 is a representation of the process steps for producing the device to detect moisture,
[074] figure 9 another form of execution of the device to detect moisture in schematic representation,
[075] figure 10 a matrix to show the crossing points of the device's warp and weft threads to detect moisture in figure 9,
[076] figure 11 an equivalent electrical circuit of the device in figure 9,
[077] figure 12 a representation to show the sensitive areas of the device of figure 9,
[078] figure 13 a representation to show the various cuts through the device of figure 9,
[079] figure 14A - figure 14E
[080] a representation to show the connections between the warp and weft threads of the device of figure 9 in the cutting planes of figure 13,
[081] figure 15 is an example of executing the flap of the device to detect moisture,
[082] figure 16 another example of executing the device flap to detect moisture,
[083] figure 17A is another example of how the device can be used to detect moisture in a side view,
[084] figure 17B the device for detecting moisture from figure 17A in the top view together with a representation of the individual layers in a table,
[085] figure 18 is another example of how the device can detect moisture together with a representation of the individual layers in a table,
[086] figure 19 is another example of how the device can detect moisture together with a representation of the individual layers in a table,
[087] figure 20 shows another example of the device to detect moisture together with a representation of the individual layers in a table,
[088] figure 21 is another example of how the device can detect moisture together with a representation of the individual layers,
[089] figure 22 is another example of how the device can detect moisture together with a representation of the individual layers and
[090] FIGURE 23 another example of executing the device to detect moisture together with a representation of the individual layers.
[091] Figure 1 shows the essential components of a blood treatment device, especially a hemodialysis device A, which has a device B to monitor arterial and venous vascular access. In the present execution example, the monitoring device B is a component of the hemodialysis device A. Initially, the dialysis device is described with reference to figure 1.
[092] The hemodialysis device A features a dialyzer 1, which is subdivided by a semipermeable membrane 2 in a blood chamber 3 and in a dialysis fluid chamber 4. In the patient's fistula or shunt, it is connected, by means of an arterial puncture cannula 5, an arterial conducting tube 6, which leads to the entrance of the dialyzer blood chamber. From the outlet of the blood chamber 3 of the dialyzer 1, a venous conducting tube 7 is broken, which is connected via a venipuncture cannula 8 to the patient's fistula or bypass. The arterial conductive tube 6 is connected to a blood pump 9, which carries blood in the extracorporeal circulation.
[093] The dialysis fluid circulation II of dialysis device A comprises a source of dialysis fluid 10, to which is connected a dialysis fluid supply tube 11, which leads to the entrance of the dialysis fluid chamber 4 of the dialyzer. A dialysis fluid outlet tube 12 leaves from the dialysis fluid chamber 4 of the dialyzer 1, which leads to an outlet 13. A dialysis fluid pump 14 is connected to the dialysis fluid outlet tube 12.
[094] The dialysis device control takes on a central control unit 15, which activates the dialysis fluid and blood pump 9, 14 through control tubes 16, 17. The central control unit 15 is connected via a data transmission cable 18 with an alarm unit 19, which in the event of an accident, triggers an optical and / or acoustic and / or tactile alarm.
[095] Downstream of the blood chamber 3 of the dialyzer 1, in the venous conductive tube 7, an electromagnetically operated tube clamp 20 is located, which is closed by the central control unit 15 by means of another control tube 21, when the venipuncture cannula (needle) leaves the vascular access and the humidity sensor should be moistened with blood. In addition, after leaving the cannula by moistening the sensor, the control unit 15 stops the blood pump 9.
[096] The monitoring device B serves, in the present execution example, to monitor the venous vascular access. The monitoring device B has a device 40 for detecting moisture, which is arranged at the puncture point. This detection device 40 is shown schematically in figure 1. In addition, the monitoring device has an evaluation unit 41, which is electrically connected to the detection device 40 via a connection tube 42.
[097] Via the data transmission cable 43, the evaluation unit 41 is connected to the central control unit 15 of the dialysis device A. In the event that blood leaves the venous cannula and / or the puncture point and moistens a humidity sensor, the evaluation unit 41 of the monitoring device B produces a control signal, which the central control unit 15 captures via the data transmission cable 43, which makes an intervention in the treatment of blood. The control unit 15 stops the blood pump 9 and closes the tube clamp 20. In addition, the control unit produces an alarm signal, so that the alarm unit 19 provides an acoustic and / or optical alarm and / or tactile. The data between the monitoring device B and the dialysis device A can also be transmitted wirelessly.
[098] The following describes a first example of execution of the device 40 to be placed on the patient's skin at the puncture point to detect moisture. The detection device 40 is formed as a plug of a flat textile structure (fabric) to be placed on the patient's skin. In the first example of execution, the flat textile structure 100 is a multilayer fabric, which has three layers (planes).
[099] Figure 2 shows a cross-section through the three-layer fabric 100. Figure 2 shows the warp threads that extend from left to right. The cross section shows a total of 600 warp threads 101 - 106. The number of layers of the fabric is defined according to the number of the planes 110, 120, 130, in which the weft threads 107, 108, 109 are located; 107 ', 108', 109 '. The weft threads 107, 108, 109; 107 ', 108', 109 'which are in the three planes 110, 120, 130 essentially perpendicular to the warp threads, are characterized by circles. The production of a three-layer fabric is known to the expert. In weaving, the weft yarns 107, 108, 109; 107 ', 108', 109 'are in three planes 100, 110, 120. The warp threads 101 - 106 are added to the three planes. Of the three planes of warp yarn, each individual warp yarn can be raised or lowered to allow the passage of a weft yarn hook. In the three-layer fabric, in the production of originally 60 threads / cm in one plane, 20 threads are taken to an upper plane, 20 threads are taken to an intermediate plane and 20 threads are taken to a lower plane. The number of 60 threads / cm represents a conventional example, however, it can also deviate from this.
[100] In the weaving process, weft threads 107, 108, 109; 107 ', 108', 109 'need not necessarily be taken to overlapping planes, but the layer of a weft thread in a plane in the weaving process can result in the "return to the original position" of the raised warp yarns or lowered, which pull the weft thread, in this case, obligatorily to a defined plane. Plans must always be understood as "imaginary" layers, which need not be "flat".
[101] In the present execution example, detection device 40, which is also referred to as a plug, is U-shaped. The U-shaped plug 40 has a central area 40A with two arms 40B, 40C, that laterally surround a semicircular notch 40D. In the central section 40A, a flap 40E is formed opposite the two arms 40B, 40C.
[102] The multilayer fabric consists of electrically conductive and electrically non-conductive warp and weft threads (monofilaments, carbon fibers, silver polyamide thread). The electrically conductive and electrically non-conductive warp and weft threads are arranged in such a way that the fabric has a lower layer to be placed on the patient's skin, an intermediate layer and an upper layer not facing the patient's skin.
[103] Figure 3A shows the bottom layer of the fabric. The lower tissue layer is electrically non-conductive. In this plane, there are no electrically conductive warp and weft threads. But it is also possible to give up the bottom layer. The electrically conductive warp and weft threads are in the middle and upper plane. In these two planes, the conductive and non-conductive warp and weft threads form an electrically conductive structure. In the case of the electrically conductive structure, there are two conducting paths, each extending over the entire plug. Both conductive pathways are made up of sections that extend perpendicularly to each other, as explained below.
[104] Figure 3B shows the middle layer of the tissue. The electrically conductive warp yarns 50, which are located in the intermediate plane, are characterized by vertical lines. These warp threads form the sections of the two conductive pathways that extend in a first direction, if by creating suitable points of contact or insulation, they are "assigned" to a conductive path.
[105] Figure 3C shows the top layer of the fabric. The electrically conductive weft threads 60 are characterized by horizontal lines. These weft threads form the sections of the two conductive pathways, which extend in the second direction following orthogonal to the first direction, when, when creating suitable points of contact or insulation, they are "assigned" to a conductive path.
[106] In figure 3D, the electrically conductive warp and weft threads 50, 60 of the fabric are characterized by vertical and horizontal lines. It results in a structure in the form of a grid of electrically conductive wires.
[107] The two conducting pathways 80, 90 are formed in the middle and upper plane of the fabric by the fact that the electrically conductive warp and weft threads 50, 60 are arranged at the crossing points 70 in such a way that either they are electrically conductive or electrically isolated from each other. A point of contact between the warp yarns and electrically conductive weft is obtained by a partial change of plane of the warp yarn during the weaving process, as shown in figure 2.
[108] Figure 2 shows the weft threads 107, 108, 109; 107 ', 108', 109 'which are in the three planes 110, 120, 130. By partially exchanging the electrically conductive warp yarn 102, for example, from the upper plane 110 to the lower plane 130, an electrical connection is produced between this warp thread 101 and that electrically conductive weft thread 109 in the lower plane, which intersects the warp thread 102. Without the partial exchange of the planes, the electrically conductive warp and weft threads are isolated from each other. For example, the electrically conductive warp yarn 102 is not electrically connected to the electrically conductive weft yarn 109, since the warp yarn 102 does not partially exchange the plane in the area of the weft 109.
[109] Figure 3E shows the electrical contact points at the crossing points 70 between the electrically conductive warp yarns 50 of Figure 3B and the electrically conductive braided wires 60 of Figure 3C, as circles. The conductive path 80 results in a closed conductive circuit, which runs from the flap 40E through the central area 40A to the left arm 40B and from the left arm 40B through the central area 40A to the right arm 40C and from the right arm 40C through the central area 40A back to the flap 40E of the buffer 40. The straight sections in a position orthogonal to each other can clearly be recognized 80A, 80B of the first conducting track 80. The two ends of the conducting track 41 form the two joining contacts 80C, 80D of the first via conductive 80. Both 80C, 80D connection contacts are located on the outside of the flap.
[110] The second conductive track 90 with sections 90A, 90B extending vertically to each other, is shown in figure 3F. It follows again from the flap 40E through the central area 40A to the left arm 40B and from the left arm 40B through the central area 40A to the flap 40E of the buffer 40. The two ends of the second conductive path form a second pair of 90C joining contacts , 90D, which are arranged on the flap 40E between the connection contacts 80C, 80D of the first conductive track 80.
[111] Figure 3G shows the two conducting tracks 80, 90 together with the contact points. The individual sections 80A, 80B, 90A, 90B of the two conducting tracks 90, 90 are arranged in such a way that they follow essentially parallel to each other.
[112] For the best visualization, in figures 3E to 3G, only the sections of the woven and twisted conductive wires, which form the conductive pathways, are drawn. The warp and weft threads, however, run through the fabric across the entire width and length.
[113] Figure 3H shows, to illustrate, the electrically conductive warp and weft threads 50, 60 of the two conductive tracks 80, 90 along their entire length. The electrically conductive warp and weft threads that intersect, however, contact only the points of contact represented by circles.
[114] In the present execution example, the electrically conductive warp and weft threads are separated, on the one hand, by the semicircular cutout 40D. On the other hand, the conductive warp and weft threads are separated by another cutout 40F, which is located in the intermediate section 40B. In the present example, this cutout is a 40F cruciform cutout. However, this cutout can also have any other desired shape. It is decisive, that with one or more additional cutouts, an electrical structure of a particular formation can be visually created, which are separated into individual conductive wires.
[115] The especially cruciform cutout 40F serves, on the one hand, for the targeted, posterior and permanent interruption of the conducting threads in the finished fabric, so that in the finished product, a single conducting path remains. With the 40F cutout, redundant conducting paths should be avoided. On the other hand, the cutout 40F in combination with an additional piece correspondingly formed, can serve to fix the union contacts by means of interlocking.
[116] The semicircular cutout 40D serves to pass the puncture cannula, and the plug 40 can also be placed on the patient's skin, when the puncture cannula is already in place. The intermediate recess 40F can be used to adjust and / or fix the plug on a support or clamping piece, but which is not shown in the figures.
[117] In the following, other examples of execution of the plug are described, but which differ from the execution example described with reference to figures 3A - 3B, only by the shape of the plug, as well as by the electrical structure. All forms of execution are based on the same basic principle, connecting, through the targeted creation of points of contact or isolation points, the electrically conductive warp and weft threads in a woven fabric of electrically conductive and electrically conductive threads not conducting to crossing points, electrically with each other or electrically isolating each other.
[118] Figures 4A - 41 show another way of making the U-shaped buffer 40, but which does not have a central cutout. The course of the two conducting paths differs from the course of the conducting path of the first example of execution. The elements corresponding to each other are provided with the same reference signs. In the second example of execution, another insulation plan is provided, which separates the electrically conductive warp and weft threads from the planes located above and below each other. This is visible based on figures 4A - 41.
[119] Figure 4A shows the first layer of the buffer to be placed on the patient's skin, which is not electrically conductive. On the first plane there is a second plane with 50 electrically conductive warp threads (figure 4B). In the plane with the electrically conductive warp threads there is a third plane, which is electrically non-conductive, since the electrically conductive warp and weft threads do not contact (figure 4C). In the third plane, there is a fourth plane with electrically conductive weft threads 60. In the second and fourth plane, the electrically conductive warp and weft threads 50, 60 are arranged at a different distance from each other, so that the structure represented in figure 4E.
[120] The electrically conductive warp and weft threads 50, 60, which form the first conductive path 80, show Figure 4F, while Figure 4G shows the electrically conductive warp and weft threads 50, 60, which form the second path conductor 90. Figures 4F and 4G show that the semicircular cutout 40D interrupts a part of the sections 80A, 90A that extend parallel to each other between two electrical connection points of the first and second conductive path 80, 90, which form a circuit parallel of electrically conductive wires. In this example of execution, both the first as well as the second conductive track 80, 90 each have a section of the conductive track, which is formed by more than two wires. Consequently, the first or second conductive path cannot be interrupted either when one of the at least two wires in that section of the conductive path breaks. The figures must show that, through the number and formation of the cutouts in the buffer, the redundancy can increase or decrease. To increase redundancy, the number of electrically conductive warp and weft threads, which form a parallel circuit, can increase in some or all sections of the conductive pathways of the conducting path, while to reduce redundancy, the number of warp threads or weft of some or all sections of the conducting pathways may decrease.
[121] A high redundancy of the conductive pathways, that is, a multiple of conductive wires, leads to a high sensitivity of the humidity sensor, because at each point of the sensor small amounts of blood can already be recognized between the nearby conductive pathways. A small or no redundancy results, conversely, in low sensitivity. A disadvantage of high redundancy, however, is that in a conductive path rupture, the defective function of an unexamined sensor is verified only during application, unless each individual conductive path is tested for integrity beforehand. Therefore, in the case of sensors with redundancy, an in-process control (IPK) is carried out, in which each individual conducting path in the production process is tested for functionality.
[122] In the case of sensors, which have no redundancy, an in-process control (IPK) can also be carried out, in which each individual conducting path in the production process is tested for functionality.
[123] When wires with high break resistance are used in the fabric, an electrical structure with less redundancy may be sufficient, while when using threads with a lower break resistance, an electrical structure with high redundancy is advantageous.
[124] Incidentally, the functionality of the humidity sensor can be tested by the fact that the resistance between the union contacts is measured. When a section of the conductive path of a conductive wire is interrupted, an infinitely high resistance is measured. In the case of an interruption of a wire in a section of the conductive path of several wires, which form a connection in parallel, the defect of a single wire, on the contrary, cannot be detected by the fact that an infinitely high resistance is measured.
[125] Figure 4H shows, for additional illustration, the two conducting tracks 80, 90 with the respective connection contacts 80C, 80D, 90C, 90D in the flap 40E of the buffer 40. Figure 41 shows the warp and weft threads 50, 60 that forms the two conductive tracks 80, 90 along its entire length.
[126] For the sake of clarity, in figures 4F to 4H, only the sections of the conductive warp and weft threads, which form the conductive pathways, are drawn again. However, the warp and weft threads pass through the fabric over its entire width.
[127] Figures 5A - 5F show another example of execution of buffer 40, where again the same reference signals are used for the elements corresponding to each other. In this embodiment, the plug 40 is round and has a central circular cutout 40G for the passage of the cannula. Furthermore, this example of execution differs from the forms of execution described with reference to figures 3 and 4 by the fact that only one conducting path 85 is provided in the form of a closed winding circuit.
[128] Buffer 40 consists of a three-layer fabric with a bottom layer (figure 5A), which is electrically non-conductive, an intermediate layer (figure 5B) with electrically conductive warp threads 50 and an upper layer (figure 5C ) with electrically conductive weft threads 60. Figure 5D depicts the warp and weft threads that intersect 50, 60 of the intermediate and upper plane. Figure 5E shows the contact points represented as circles between the electrically conductive warp and weft threads 50, 60, which intersect at connection points 70 (figure 5D). The overlapping of the intersecting warp and weft threads 50, 60 results from a large number of conductive circuits consisting of rectangular sections 85A, 85B extending to each other, in which the conducting path 85 follows from the outside inwards in shape helical. The two connecting contacts 85C, 85D of the conductive track 85 are led outwards and are parallel to each other.
[129] In order to prevent the electrically conductive cannula cannula from causing a short circuit in each of the conductive path sections described in each case, it is possible to create an area of tissue on the upper side of the plug insulation 40H, in which the conductive wires do not go to the surface. Figure 5G shows, as an example, an area of triangular insulation fabric 40H on the upper side of circular plug 40. The area of fabric 40H extends to the central cutout 40G for the passage of the needle. But any other arbitrary form for the insulation layer is also possible. It is only decisive that the surface of the plug facing outwards, at least in the area below the puncture cannula, is electrically non-conductive, so that the metal puncture cannula cannot cause any short circuit. As described above, this can be achieved only by the weaving process. An additional layer of local insulation, then, is no longer needed in the finished fabric, but it would also be possible, which, however, would increase expenses and costs.
[130] Figure 5F shows again all the crossing points with the electrically conductive warp and weft threads 50, 60 along their entire length.
[131] The device for detecting moisture, which has only a conducting path 85 with two connecting contacts (figures 5A - 5F), is connected to the evaluation unit 41 of the monitoring device B via a bifilar connection cable 42 ( figure 2). Terminal resistance is not required in this embodiment. Depending on the humidity, the resistance between the connection contacts 85A, 85B changes. If the resistance exceeds a predetermined limit value, it is sensitive to the evaluation unit 41.
[132] In the form of two conductive paths 80, 90 (figures 3 and 4), on the contrary, a terminal resistor R is required, which connects one end of a conductive path with the other end of the other conductive path, so that a conductive circuit is formed. The terminal resistor R is connected between the internal union contacts 90C, 90D. To the external connection contacts 80C, 80D a two-wire connection cable 42 is connected, which connects the humidity sensor with the evaluation unit 42 electrically to the monitoring device B. The total resistance of the conductive circuit is then composed of the sum of the resistances of both conductive pathways 80, 90 and the terminal resistance R. In the case of the terminal resistance, it is a resistance of high ohmic value, especially a resistance greater than 100 kOhm, while the resistances of the conductive path are low ohmic value. Electrically conductive wires can, as such, exhibit, for example, a resistance of specific length of 100 Ohm per meter of wire length. For example, the resistances of the conductive pathways of woven conductive pathways, including the resistances of all connection points are, in sum, less than 1 kOhm.
[133] The evaluation unit 42 of the monitoring device measures the resistance between the 80C, 80D connection contacts. When the buffer 40 is to be moistened with fluid, especially blood, the resistance measured between the union contacts decreases, so that the evaluation unit 41 detects a failure.
[134] The evaluation unit 41 also allows an inspection of the functionality of the detection device 40. For this purpose, the evaluation unit 41 measures the resistance between the connecting contacts. This resistance must correspond to the sum of the terminal resistance R and conductive path resistance, if the buffer 40 is not moistened with fluid. If the resistance measured by a predetermined difference must vary from the terminal resistance, the evaluation unit verifies that the detection device 40 is not capable of functioning, that is, a conductive path is interrupted.
[135] The detection device 40 according to the invention with the two conducting paths has the advantage that the particular conduction of the conducting path allows the displacement of the terminal resistor R outside the plug. This makes it easier to finish the plug.
[136] For in a weaving process, the terminal strength could not be produced with sufficient reproductive capacity. Therefore, the buffer can be produced without additional process steps only by weaving. A terminal resistance does not need to be applied to the plug, also after the weaving process. As a result, the advantage of a constantly reproducible end strength is independent of the weaving process.
[137] Figure 6 shows a schematic diagram of the essential elements of a connecting piece 150 to connect the plug 40 of figures 4 without cruciform cutout to the evaluation unit 41 of the monitoring device B. But fundamentally, the plug 40 of figures 3 with cruciform cutout it can also be connected to the connection piece 150. But then, the cruciform cutout cannot be used to fix the plug.
[138] The connecting piece 150 is formed as a clamping device for crimping the flap 40E of the plug 40. It has a lower clamping piece 155 and an upper clamping piece 160, with the lower clamping piece 155 having four connection contacts 156, 157, 158, 159 next to each other and in the upper clamp 160, four connection contacts 161, 162, 163, 164 next to each other. The upper and lower clamping parts 155, 160 can be clamped together, the flap 40E of the plug 40 with the union contacts 80C, 80D, 90C, 90D is located between the union contacts 156, 157, 158 , 159 and 161, 162, 163, 164 opposite each other from the upper and lower clamp 155, 160. The two internal contacts 162, 163 inside the clamp 160 are electrically connected to each other via a resistor termination R represented only schematically. The terminating resistor R can be an SMD resistor integrated with the upper clamping piece 160 (miniature resistor).
[139] Figure 7 shows a schematic representation of a second example of execution of the connecting piece 170 formed as a clamping device. The connecting piece 170 has arms 175, 180 elastically connected with each other, one arm 175 being longer than the other arm 180.
[140] The longer lower arm 175 shown in Figure 7 of the connector 170, has a projecting projection 185, which in shape corresponds to a cutout of a plug. In the present embodiment, the protruding shoulder 185 is cruciform, since the appropriate plug not shown has a central cruciform cutout 40F. But any other desired shape is also possible.
[141] The shorter upper arm 180 has four joining contacts 181, 182, 183, 184 next to each other, which are formed as punches. On the opposite inner sides of the two arms 175, 180, locking means 190 are provided, represented only by reference, so that the arms are fixed locked after compression. Also in this embodiment, the two internal connection contacts 182, 183 of the connection piece 170 are connected via a terminating resistor R, which is formed as an SMD resistor integrated with the upper arm 180.
[142] To connect the detection device 40 to the monitoring device B, the plug not shown is placed between the two arms 175, 180 of the connecting piece 170, so that the cruciform projection 185 grips the cruciform cutout 40F of the buffer 40 Then, the two arms 175, 180 of the connecting piece 180 are compressed, and the connecting contacts 181, 182, 183, 184 of the connecting piece 170 come into contact with the connecting contacts 80C, 80D, 90C, 90D of the buffer. In this case, the plug is fixed by the punching contacts 181, 182, 183, 184.
[143] Figure 8 shows the essential procedural steps of the weaving process for the production of the detection device according to the invention. To produce the fabric preferably of multilayers, warp yarns 50 and weft yarns 60 are provided. After the production of the fabric, other process steps known to the skilled person are carried out, which include washing. Then, a covering material with an adhesive or adhesive layer is applied to the underside of the fabric strip. The adhesive can be applied, for example, with a cylindrical brush. Preferably, an adhesive coated silicone paper is applied to the back side of the fabric strip. Alternatively and particularly preferably, a bilaterally self-adhesive film, for example, a PET film, is applied to the rear side of the fabric strip. The function of an adhesive film is, on the one hand, to provide a barrier against soaking the buffer sensor with the patient's sweat. On the other hand, with the bilaterally adhesive film a different adhesive force can be provided on the upper and lower sides. Preferably, on the side facing the patient's skin, the film has a lower adhesive force than on the side away from the skin and facing the tissue. On the side facing the skin, the adhesive film preferably has a silicone paper to protect the adhesive layer.
[144] Instead of silicone paper, a siliconized plastic film can also be used. It is crucial, that the adhesive layer of the sensor can be easily separated from the silicone paper or the siliconized plastic film.
[145] The plugs are then separated from the fabric strip, for example, by stamping or cutting. In the stamping or cutting process, the cutouts of the plugs can also be produced.
[146] The plugs can be individually packed in a sterile way or several plugs can be packed in a sterile way. However, sterile packing of the plugs is not necessarily necessary. When using plugs to monitor a central venous catheter, a sterile plug is preferably used, which has been sterilized, for example, with the known ETO (ethylene oxide) or E-Beam (Electron Beam Sterilization) sterilization processes. Alternatively, steam sterilization can also be performed.
[147] For use, the cover material is removed from the tampon and the tampon is placed with the adhesive or adhesive layer on the patient's skin. Then, the puncture can be performed with the cannula. But it is also possible to place the tampon on the patient's skin after the puncture, if the tampon is laterally notched. It is possible to connect the connection piece before or after placing the plug on the patient's skin.
[148] Figure 9 shows another example of making the device to detect moisture in schematic representation, which is then referred to again as a buffer. The plug, with the exception of the central cutout, has the same shape as the plug described with reference to figures 3A through 3H. This features a central area 200A with two arms 200B, 200C, which surround a semicircular notch 200D laterally. In the central area, a flap 200E is molded, which is opposite the two arms.
[149] The electrically conductive warp and weft threads that form an electrically conductive structure are characterized by thin horizontal and vertical lines. In this embodiment, unlike the examples described above, the weft threads S extend in a vertical direction and the warp threads K in a horizontal direction. The electrically conductive structure is formed by 8 warp threads K [1] to K [8] and 12 weft threads S [1] to S [12], which are arranged at the crossing points in such a way that they are or electrically connected conductors or are electrically isolated from each other.
[150] Figure 10 shows a matrix to show the 88 crossing points of the 8 warp threads K [1] to K [8] and 12 weft threads S [1] to S [12]. The points of intersection of two conductors, which produce a contact, are designated in the matrix with "cont.", While the points of intersection of two conductors, which form an isolation point, are designated with "Isol.". The result is an electrically conductive structure, which has two conductive pathways, which each form a conductive circuit realized in a non-redundant way.
[151] Figure 9 shows the electrical contact points at the crossing points between the electrically conductive warp and weft threads K [i], S [i] as circles. The first conductive path L1A-L1E extends from the flap 200D through the central area 200A to the left arm 200B and from the left arm through the central area to the right arm 200C and from the right arm through the central area back to the flap of the plug . The start of the respective conductive path is designated with "A" and the end of the conductive path with "E". The two ends LIA, LIE of the first conductive path L1A-L1E form the two joining contacts. The second conductive path L2A-L2E extends from the flap 200D through the central area 200A to the left arm 200B and from the left arm through the central area to the right arm 200C and from the right arm through the central area to the flap of the buffer 40. The two ends L2A, L2E of the second conductive path L2A-L2E form the second for contact contacts. On the 200D tab, the connection contacts are arranged in such a way that the connection contacts L2A and LIE are located between the connection contacts LIA and L2E.
[152] The fabric of the embodiment in figure 9 can be a three-layer fabric that extends over the entire sensor, which has a first non-conductive layer, a second conductive layer with conductive threads in a first direction and a third conductive layer with conductive wires in a second direction, the second direction being essentially vertical to the first direction.
[153] An alternative embodiment provides for a fabric, in which the number of layers is locally different. In this way, the tissue can have a different number of layers in the individual regions of the sensor. In this case, three different regions can be formed, in which the first area forms a contact point, in which the conducting wires cross through contact, the second area forms an isolation point, in which, between the conducting wires, an insulating wire is located and the third area forms neither a contact point nor an isolation point.
[154] A particularly preferred form of execution provides that local regions, which form a point of contact and local regions, which form neither a point of contact nor an isolation point, consist of two layers altogether. In the first layer are found both the conducting wires that extend in the first direction, as well as those that extend in the second direction. The second (upper) layer forms a non-conductive covering layer, which provides that the sensor is advantageously not sensitive to contacts. If the sensor were sensitive to contacts, the contact of the exposed sensor sensor surface glued to the patient, for example, with fingers, would have a false alarm as a consequence. Such contact of the sensor can be made, for example, by the patient himself or by medical personnel. The wires of this second insulating layer partially immerse in the first layer, with which a mechanical composite is produced between the first and second layers.
[155] The particularly preferred form of execution also includes a local area forming an isolation point, which has a total of four layers. In the first (bottom) layer are the conducting wires that extend in the first direction. The second layer has a layer of non-conductive wires, which insulates the first from the third layer. In the third layer are the conducting wires that extend in the second direction. The fourth (upper) layer is formed by a non-conductive covering layer, which makes the sensor advantageously insensitive to contact.
[156] The isolation point described above can be provided, for example, at points, which in figure 10 are designated "Isol". In this execution example, 66 isolation points result. The isolation of the skin in this embodiment is achieved with an insulating adhesive film.
[157] The buffer with the locally different regions has a different thickness. A particular advantage of this form of execution lies in the saving of material, because the plug only needs to be sufficiently thick at the points, where the electrically conductive wires must be isolated from each other. The material savings allow for particularly economical sensor production.
[158] The plug of figure 9 can be connected to a connection piece, which is distinguished from the connection piece described with reference to figure 6 only in the fact that the terminating resistor R is connected with an internal connection contact and an external one.
[159] Figure 11 shows the equivalent electrical diagram of the electrically conductive structure of the pad connected to the connection piece. The equivalent scheme is a series connection of the resistor RI of the first conductive path L1A-L1E, the resistor RI of the terminating resistor and the resistance R3 of the second conductive path L2A-L2E. The resistances RI and R3 of the first and second conductive path should preferably not be greater than 200 Ω each.
[160] The buffer sensitivity to moisture does not only exist directly in the area of the conductive structure of the warp and weft threads, but also in the marginal areas of the plug, as the warp and weft threads extend to the edge of the plug . In figure 12, as an example, two marginal areas of the buffer are characterized with circles, in which the buffer is sensitive to moisture. In addition, the buffer sensitivity to moisture can be adjusted with a non-conductive woven cover layer.
[161] Figures 14A to 14E show a cut through the cover 210 (liner), for example, a silicone paper and the interweaving of the warp and weft threads in the cutting planes, which are shown in figure 13. In cutting plane V - V, the warp threads K [i] and weft S [i] are not intertwined, because in this plane there are no weft threads. In the cutting plane W - W, the warp yarn K [8] is interlaced with the weft yarn S [9], as well as the warp yarn K [8] with the weft yarn S [11], so that an electrical connection is established between the warp and weft threads. In the cutting plane X - X, the warp threads K [i] and the weft threads S [i] are not intertwined, because in this plane there are no weft threads. In the Y - Y cutting plane, the warp yarn K [7] is interlaced with the weft yarn S [10], as well as the warp yarn K [7] with the weft yarn S [12], so that an electrical connection is established between the warp and weft threads. In the Z - Z cutting plane, the warp threads K [i] and the weft threads S [i] are not intertwined, because in this plane there are no weft threads.
[162] Figure 15 shows in schematic representation the arrangement of the LIA, LIE and L2A, L2E connection contacts in the 200D tab of the plug execution described above. The ends of the warp and weft threads extend in these forms of execution in the same distance to the edge of the flap. To form the connection contacts LIA, LIE and L2A, L2E, the wires are located on the surface of the 200D flap. To avoid a short circuit between the connecting contacts of the connecting piece, the width or diameter of the connecting contacts of the connecting piece must be less than the distance between the connecting contacts LIA and L2A, L2A and LIE, as well as LEL and L2E of the buffer. As a result, the width or diameter of the connection contacts of the connection piece is limited.
[163] Figure 16 shows an alternative embodiment of the arrangement of the connection contacts to the flap 200D of the plug in schematic representation, in which the connection contacts LIA and LIE of a conductive path L1A-L1E are arranged out of alignment with respect to connection contacts L2A and L2E of the other conductive path L2A-L2E. The connection contacts LIA and LIE of one conducting path are, in this case, in the upper half and the connection contacts L2A and L2E of the other conducting path, in the lower half of the flap 200D. Since the plug has a layer of insulating woven cover on the surface, targeted "dipping" of the threads is possible. In the embodiment of figure 16, the weft threads S [5] and S [7] (figure 9) are in the lower half of the flap below the covering layer and the weft threads S [6] and S [8] (figure 9), in the upper half of the flap below the cover layer, so that the joining contacts of the joining piece can have a larger width or a larger diameter than in the example of execution of figure 15, without occurring a short - circuit between contacts LIA and LIE or L2A and L2E.
[164] In the following, other alternative ways of implementing the buffer are described, which are distinguished from each other in the form and along the conductive pathways. Figure 17A shows a plug 300 that splits into two halves in a side view, in which one half after being placed on the patient's skin is folded over the other half. Figure 17A shows the side view of the plug after folding.
[165] In figure 17B, the plug in figure 17A is shown in the top view before being folded. The first half of the buffer, which is placed on the patient's skin, is designated with 300A, while the second half of the buffer to be folded is designated with 300B. The plug consists of several layers, which in Figure 17B are described in the form of a table associated with the plug, showing the lines or columns associated with the individual areas of the plug. The first half 300A of buffer 300 is divided into two fields (two columns in the table) of the same size. A field (a column in the table) is associated with the second half 300B of buffer 300. The lines in the table characterize the individual layers.
[166] The lower layer forms a cover 210, for example, a removable film, with which a layer of adhesion 220 adheres over the patient's skin. As is evident from the table, the cover 210 is on the underside of the two halves 300A and 300B of the buffer 300, since all fields are characterized with "X". Adhesion layer 200, in contrast, is only in the central area of the first half 300A of buffer 300.
[167] After the adhesion layer 220, a layer 230 is impermeable to moisture or fluid, for example, a PET film, which extends over the entire surface of the plug. On the upper side of the PET film is an adhesive coating 240, on which is a multilayer fabric 250 with an electrically conductive structure, which is formed by 12 warp threads K [1] to K [12] and 12 weft threads S [1] to S [12].
[168] The intersection points, at which an electrical connection is produced between the warp and weft threads, are again characterized with a circle in figure 17B. The intersecting warp and weft threads are again arranged in such a way that they form a first and a second conductive path, the ends of which form the connection contacts LIA, LIE and L2A, L2E of buffer 300. In this case, the paths conductors are arranged in such a way that the two electrical circuits are not redundant.
[169] The first half 300A of the rectangular plug has a central circular cutout 310, from which extends a narrow cutout 320 which runs obliquely to the narrow side of the first half of the plug. The second half 300B of the plug 300 is cut in such a way that on the inside a flap 330 for the contact contacts LIA, LIE and L2A, L2E results and on the outside, a circular cover 340 for the circular cutout 310 of the first half of the buffer. The circular cover 340 of the second half, in this case, is larger than the circular cutout 310 of the first half, so that the circular cutout of the first half of the circular cover is completely covered, if the second half of the plug is folded over the first half.
[170] Buffer 300 is used as follows. After placing the cannula not shown and removing the removable film 210, the plug is glued with the adhesive layer 220 on the patient's skin. Since the plug is laterally notched, the plug can be pushed laterally over the cannula already in place, so that the cannula is in the circular cutout 310 of the first half of the plug. Now, the second half 300B of the buffer is folded over the first half 300A (figure 17A). Since only the central area of the first half of the tampon adheres to the patient's skin, the second half of the tampon can be easily covered for this purpose. The second half 300B can be attached to the skin at the puncture point, for example, with adhesive tape. After folding the plug, the flap 330 is free of the connection contacts LIA, LIE and L2A, L2E, so that the connection piece can be connected.
[171] In the plug, the electrically conductive structure with the warp and weft threads is on the top side of the plug, so that the plug is sensitive on the top side. This is evident from the table by the designation "a", which represents the sensitivity on the upper side. After folding the second half 300B over the first half 300B of the plug 300, the plug in the area of the circular cutout 310, which is in direct proximity to the puncture point, is also sensitive on the underside, as this area is covered through the sensitive cover 340 before folding on the upper side.
[172] Figure 18 shows another way of carrying out buffer 400, but which, unlike buffer 300 of figure 17A and figure 17B, is not folded. The parts corresponding to each other are provided with the same reference signs. The formation of the multilayer plug results from the table and the representation of the intersection points, in which an electrical connection is produced between the warp and weft threads. The intersecting warp and weft threads are again arranged in such a way that they form a first and a second conductive path, the ends of which are the connection contacts of the plug. The electrically conductive structure is formed by 12 warp threads K [1] to K [12] and 12 weft threads S [1] and S [12].
[173] In the example shown in Figure 18, plug 400 is essentially rectangular. On the one hand, the plug has, for example, a rectangular cutout 410, while the plug has a flap 420 on the side opposite the cutout. The rectangular cutout 410 on one side of the plug follows on one side of the plug as a narrow slot 430, which passes through the conductive pathways, so that the two energy circuits of the electrically conductive structure are not redundant. The width of the slot 430 is measured in such a way that the impact points of conducting wires cannot cause a short circuit. In the execution example, the slot 430 has, for example, a U-shaped course, the slot partially surrounding the central area 440 of the plug, which can be placed over the puncture point.
[174] The table shows that the plug 400 in the central area 440, which is surrounded by the narrow slot 430, is sensitive on the lower side, as this area is designated in the table with "s", which represents a sensitivity on the side bottom. In other areas, the plug, on the other hand, is sensitive on the upper side ("a"). The sensitivity of the bottom side of the plug is obtained by the fact that the PET 230 film impermeable to water and moisture is not present in the central area 440, which results from the table. In this area, adhesion layer 220 and adhesive coating 240 (table) are also missing.
[175] The advantage of this embodiment is that the puncture point is additionally covered with sensitive tissue on the underside, so that the plug is bilaterally sensitive. Leakage bleeding at the puncture point can be recognized immediately and safely with the sensitive plug also at the bottom. Since the other areas on the upper side are sensitive, the cannula placed under the plug must not cause any short circuit.
[176] Another way of making a bilaterally sensitive plug 500, which is folded, shows figure 19. The parts corresponding to each other are again provided with the same reference signals. The intersecting warp and weft threads are again arranged in such a way that they form a first and a second conductive path, the ends of which form the connection contacts of the plug, the two electrical circuits being not redundant. The electrically conductive structure is formed by 10 warp threads K [1] to K [10] and 14 weft threads S [1] to S [14].
[177] The plug has a central section 510 with two arms 520, 530, which surround a semicircular cutout 540 laterally. In the central section 510, a flap 550 opposite one of the two arms 520, 530 is molded with the LIA joining contacts , LIE and L2A, L2E. The plug 500 furthermore has a side cover 560 for the semicircular cutout 540, which is molded in one of the two arms 520, 530. The side cover 560 is measured in such a way that the semicircular cutout 540 of the plug, in which the cannula is completely covered after folding the cover.
[178] As shown in the table, plug 500 before folding cover 560 is sensitive only on the upper side. After folding the cover, the plug in the area of the semicircular cutout 540 is also sensitive on the underside, so that leakage bleeds that arise at the puncture point can be recognized safely.
[179] Figure 20 shows another way of making buffer 600, which does not need to be folded, to be bilaterally sensitive. The electrically conductive structure of the plug is formed by 12 warp threads K [1] to K [12] and 12 weft threads S [1] to S [12]. The plug 600 has on the side, which is opposite the flap 610, a shoulder 620, which is in the area of the puncture point. In the area of this 610 shoulder, the plug is sensitive on the lower side, in the other areas on the upper side (table). A narrow semicircular notch 630 that connects to the shoulder cuts the wires again in such a way that the two electrical circuits of the electrically conductive structure are not redundant.
[180] Figure 21 shows another way of making a plug 700, which is sensitive only on the upper side (table). The electrically conductive structure of the plug is formed by 10 warp threads K [1] to K [10] and 14 weft threads S [1] to S [14]. The plug stands out for a central, eg oval, 710 cutout, from which a narrow notch 720 extends to the side of the plug, which is opposite flap 730 with the LIA, LIE and L2A, L2E connection contacts. The cannula is in the central cutout 710. Since the cannula is almost completely enclosed by the plug, leakage bleeding can also be recognized safely in the opposite direction to the needle.
[181] Another example of making a sensitive plug 800 on the upper side only, shows figure 22. The electrically conductive structure of the plug is formed by 4 warp threads K [1] to K [4] and 8 weft threads S [1] to S [8]. The plug differs from the plug in Figure 21 essentially in the fact that the notch 820 that starts from the central cutout 810 does not extend to the side, which is opposite the flap 830, but through the flap itself. Thus, the flap 830 is divided into two halves 830A, 830B, in which, in each case, two contact contacts LIA, LIE or L2A, L2E are arranged. The central cutout 810 is not oval in this form of execution, but circular.
[182] Another form of execution shows Figure 23, which is bilaterally sensitive. The plug 900 has a central section 910, which is sensitive on the underside. With the central section 910, the plug is placed over the puncture point. The electrically conductive structure of the plug is formed by 4 warp threads K [1] to K [4] and 4 weft threads S [1] to S [4], which intersect in a central section 910. The crossing points , in which the wires come into contact, are characterized by circles.
[183] This form of execution differs from other plugs, especially since the plug has two flaps 920, 930 each with four LIA, LIE or L2A, L2E connection contacts, which are molded in the central section 910 The two flaps 920, 930 may contain, for example, a 90 ° angle. The advantage of this embodiment is that the connection piece can be connected to the plug at two different points. In this form of execution, the conductor circuit is not redundant.

权利要求:
Claims (24)
[0001]
1. Device to detect moisture for use with a device to monitor a patient's access to equipment, with which a fluid is supplied to a patient and / or a fluid is taken from the patient, through a conductive tube, especially to monitor vascular access in an extracorporeal blood treatment, in which a patient's blood is taken from the patient through an arterial conductive tube, which features an arterial cannula, and is delivered back to the patient via a venous conductive tube, which has a venipuncture cannula, and the device for detecting moisture is formed as a flat structure to be placed on the patient's skin, said device comprising an electrically conductive structure as a moisture sensor characterized by: the device for detecting moisture is formed as a fabric made of non-conductive warp yarns and non-conductive weft yarns, as well as conductive warp yarns (50) and coarse weft yarns nductors (60), in which the conductive and non-conductive warp and weft threads are arranged in such a way that the electrically conductive structure is formed.
[0002]
Device according to claim 1, characterized in that the electrically conductive structure comprises a first conductive path (80) and a second conductive path (90), in which the ends of the two conductive paths are formed as connecting contacts (80C , 80D, 90C, 90D) and the first conductive path and the second conductive path in a plurality of sections (80A, 80B; 90A, 90B) are arranged side by side.
[0003]
Device according to claim 1, characterized in that the electrically conductive structure has a conductive path (85) formed as a closed conductive circuit, the ends of which are formed as connecting contacts (85C, 85D), the conductive path being it has a plurality of sections (85A, 85B) arranged side by side.
[0004]
Device according to any one of claims 1 to 3, characterized in that the electrically conductive structure comprises a plurality of electrically conductive sections (80A, 80B; 90A, 90B; 85A, 85B) extending in a first direction and extend in a second direction, the first and second directions being orthogonal to each other.
[0005]
Device according to any one of claims 1 to 4, characterized in that the flat textile structures are formed, at least partially, as a fabric comprising a plurality of layers.
[0006]
Device according to claim 5, characterized in that the electrically conductive and electrically non-conductive (50, 60) warp and weft threads are arranged in the multilayer fabric in such a way as to form: a non-conductive layer, the which is placed on the patient's skin; a layer, in which the electrically conductive sections of the conductive path are located, extend in the first direction; and a layer, in which are the electrically conductive sections of the conductive path that extend in the second direction.
[0007]
Device according to claim 6, characterized in that the electrically conductive and electrically non-conductive warp and weft threads (50, 60) are arranged in the multilayer fabric, in such a way that an intermediate layer, which is not electrically conductive, is located between the layer on which are the sections of the conducting path that extend in the first direction and the layer on which are the sections of the conductive path that extend in the second direction.
[0008]
8. Device according to claim 6 or 7, characterized in that, to create electrical contact points (70), the electrically conductive warp threads (50) partially change the position in the multilayer fabric in such a way, that electrically conductive warp and weft threads come into contact at the crossing points.
[0009]
Device according to any one of claims 2 to 8, characterized in that the sections of the conductive path are formed by a plurality of electrically conductive warp and weft threads (50, 60) which extend next to each other.
[0010]
Device according to claim 9, characterized in that the flat textile structure is cut out in such a way that a part of the electrically conductive warp and weft threads (50, 60) extending next to each other is cut.
[0011]
Device according to claim 10, characterized in that the flat textile structure comprises a circular cutout (40G) or a cruciform cutout (40F).
[0012]
Device according to any one of claims 1 to 11, characterized in that the flat textile structure is formed in a U-shape.
[0013]
Device according to any one of claims 1 to 11, characterized in that the flat textile structure is formed in a circular shape.
[0014]
Device according to any one of claims 1 to 13, characterized in that the flat textile structure comprises a flap (40E), in which the connecting contacts (80C, 80D; 90C, 90D) are arranged.
[0015]
Device according to any one of claims 1 to 14, characterized in that the flat textile structure comprises a section with a cutout (310; 540) and a section with a cover (340; 560) for the cutout, the electrically conductive structure is formed in such a way that the flat textile structure is sensitive to moisture on the upper side.
[0016]
16. Device (B) to monitor the access of a device to a patient, with which a fluid is supplied to a patient and / or a fluid is removed from the patient, through a conductive tube, especially to monitor vascular access in a treatment of extracorporeal blood, in which the blood of a patient is drawn through an arterial conductive tube, which has an arterial cannula and delivered back to the patient via a venous conducting tube, which has a venipuncture cannula, said device characterized in that it comprises a device for detecting moisture according to any one of claims 1 to 15.
[0017]
17. Device according to claim 16, characterized in that the monitoring device (B) has an evaluation unit (41) connectable to the device to detect moisture (40).
[0018]
18. Device according to claim 16 or 17, characterized in that the monitoring device has a connecting piece (150; 170), to which it can be connected to the device (40) to detect moisture.
[0019]
19. Device according to claim 18, characterized in that the connection piece (150; 170) has four connection contacts (156-159; 181-184), in which two connection contacts (160, 164; 181, 184) are connected to a connection cable (42) to produce an electrical connection between the evaluation unit (41) of the monitoring device (B) and the device for detecting moisture (40) and two joining contacts (162 , 163; 182, 183) electrically connected with each other through a terminating resistor (R).
[0020]
Device according to claim 19, characterized in that the connecting piece (150; 170) is formed as a clamping device for tightening the flat textile fabric.
[0021]
21. Device for treating blood with an extracorporeal blood circulation (I) characterized by comprising an arterial blood conduit (6) with an arterial cannula (5) and a venous blood conduit (7) with a venous cannula (8) and further comprising a device for monitoring (B) arterial and / or venous vascular access according to any one of claims 16 to 20.
[0022]
22. Process for the production of devices to detect moisture for use with a device for monitoring a patient's access to equipment, with which a fluid is supplied to a patient and / or a fluid is removed from the patient, through a conductive tube, especially for monitoring vascular access in an extracorporeal blood treatment, in which a patient's blood is drawn from the patient via an arterial conductive tube, which features an arterial cannula and delivered back to the patient via a conductive tube venous, which has a venipuncture cannula, said process characterized by comprising the following steps: weaving a fabric made of non-conductive warp threads and non-conductive weft threads, as well as conductive warp threads and conductive weft threads, being that conductive and non-conductive warp and weft threads are arranged in such a way, that conductive and non-conductive warp and weft threads form a structure conductive; and separate individual devices to detect moisture.
[0023]
23. Process according to claim 22, characterized in that the side of the flat textile structure to be placed on the patient's skin has an adhesive layer or an adhesive film and on the adhesive layer or adhesive film a covering material is applied which covers the adhesive layer or the adhesive film.
[0024]
24. Process according to claim 23, characterized in that the adhesive layer or the adhesive film is impermeable to moisture.

类似技术:

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BR112012023970B1|2020-11-10|device for detecting moisture and process for producing said device, device for monitoring access to a patient, blood treatment device

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TWI499437B|2015-09-11|A device for detecting moisture for a device for monitoring an access to a patient, in particular for monitoring the vascular access in an extracorporeal blood treatment

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同族专利:

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公开号 | 公开日

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EA023198B1|2016-05-31|

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EP2550038A1|2013-01-30|

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BR112012023970A2|2016-08-02|

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HK1180989A1|2013-11-01|

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EP2550038B1|2014-07-23|

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PL2550038T3|2015-01-30|

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CA2791925C|2019-04-09|

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US9867934B2|2018-01-16|

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AU2011231967A1|2012-11-15|

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ES2511140T3|2014-10-22|

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CA2791925A1|2011-09-29|

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US20150328389A1|2015-11-19|

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TWI637759B|2018-10-11|

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DE102010012545A1|2011-09-29|

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EA201290942A1|2013-03-29|

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KR101823070B1|2018-01-30|

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TW201200188A|2012-01-01|

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TW201811384A|2018-04-01|

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KR20130021357A|2013-03-05|

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CN102811753B|2016-01-27|

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AU2011231967B2|2014-12-18|

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BR112012023970B8|2021-05-25|

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US20130053754A1|2013-02-28|

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DK2550038T3|2014-10-13|

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JP5882294B2|2016-03-09|

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JP2013521959A|2013-06-13|

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WO2011116943A1|2011-09-29|

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CN102811753A|2012-12-05|

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US9119916B2|2015-09-01|

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法律状态:
2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-09-03| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-05-26| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|

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2020-08-25| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2020-11-10| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 23/03/2011, OBSERVADAS AS CONDICOES LEGAIS. |

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2021-05-25| B16C| Correction of notification of the grant [chapter 16.3 patent gazette]|Free format text: REFERENTE AO DESPACHO 16.1 PUBLICADO NA RPI 2601, QUANTO AO ENDERECO DO TITULAR. PATENTE RETIFICADA CONFORME ADI 5529, QUANTO AO PRAZO DE VIGENCIA |

优先权:

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申请号 | 申请日 | 专利标题

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DE201010012545|DE102010012545A1|2010-03-23|2010-03-23|A device for detecting moisture for use with a device for monitoring access to a patient, in particular for monitoring vascular access in an extracorporeal blood treatment|

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DE102010012545.8|2010-03-23|

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PCT/EP2011/001435|WO2011116943A1|2010-03-23|2011-03-23|Moisture detection device for use with a device for monitoring an access to a patient|

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