DE102008045878A1 - Hose e.g. intravascular hose, or tubular medical device for use with heart-lung machine and extracorporal blood circulation set, has sensor determining parameters of patient, and device arranged in lumen and connected with sensor - Google Patents

Abstract

The hose or tubular medical device (1) has a sensor e.g. pressure sensor and temperature sensor, for determining parameters e.g. vital parameters, of a patient, and a device arranged in a guidance lumen (5) and connected with the sensor. The device is designed as a wire for transferring signals of the sensor, with respect to the position of the sensor. The guidance lumen and a lumen (3) e.g. electrical wire, extend in longitudinal direction of the hose that is designed as an intravascular hose. The lumens are designed in identical or different manner.

Description

The The present invention relates to a multi-lumen tubular or tubular medical device, hereinafter referred to as "hose", according to the preamble of claim 1. Furthermore, the invention relates to an extracorporeal Blood circulation set according to the preamble of claim 10 and a device according to the preamble of the claim 11th

For the measurement medical parameters, in particular vital parameters, are from the Practice known invasive and noninvasive procedures and related equipment.

task The invention is a further device for determining Parameter values of a patient, especially his vital parameter values, specify.

The inventive task is achieved by a hose having the features of claim 1.

According to the invention is a proposed at least 2-lumen tube, with at least one Guide lumen, in which a device - im Below also called connecting device - is performed, which with a or more sensors is connected. In this case, the first lumen a larger cross-section have as the second lumen. The two lumens can be the same or differently configured. At least one of the lumens can the cross-sectional shape of a circle, a circle segment (circle section), a circular sector (circular section) or another cross-sectional shape exhibit. One lumen may be attached to the other lumen. One lumen may be located within the other lumen.

there For example, a lumen may be provided for transporting fluids such as rinse fluid. One Lumen can lead to electrical conductor or optical fiber or other instruments be designed and provided, in particular those which are not with liquids or for other reasons - for example, the mechanical Protection of the sensor or to avoid turbulence in another Lumen - isolated guided Need to become. Lumens, in which, for example, ladder or other facilities be guided relative to a direction of extension of the hose, are used according to the invention as guide lumens designated. This applies in particular to the lumen, which is the connecting device with the sensor.

Under a tubular, Medical device according to the invention, a hose or a flexible Device to be understood, which or which preferably for advancement firmer, more fluid or gaseous Substances is usable. A hose can be flexible to different curvatures to adjust.

Under a tubular device In contrast, a rigid hollow cylinder is understood, such as known rigid endoscopes. The tubular device can according to the invention any and for have the appropriate purpose suitable length and thickness. she can also for promotion firmer, more fluid or gaseous Substances be usable.

The term "sensor" as used herein refers to a technical component for quantitatively and / or qualitatively measuring physical and / or chemical properties and / or for detecting the environmental nature of the material. Examples of sensors include, but are not limited to, pressure sensors, temperature sensors, lab-on-chip sensors, flow sensors, oxygen saturation sensors, humidity sensors, blood level sensors, and combinations thereof. In this case, a sensor can have a plurality of sensor elements, for example at least one measuring device for detecting at least one measured variable at at least one measuring point, and further devices, for example for acquiring and / or converting the measured data, as well as possibly for the operation of the sensor required facilities for a power supply include the sensor or take the latter tasks with. The sensor may be configured to determine different parameters, such as pressure and temperature. This can be advantageous also perform more complex measurements. The sensor can also be designed for a measurement according to the thermodilution principle or for a measurement to determine the volume flow or flow. A sensor may preferably transform the acquired measurement data in a suitable manner for a corresponding evaluation. For example, it may convert a sensed pressure value to a voltage value. This voltage value can be transmitted to a further device for evaluating the measured data. As a sensor, therefore, a technical component is generally referred to, which can detect certain physical, chemical, biological or other properties and / or material properties qualitatively or as a quantitative measure. The properties, properties or measured variables to be determined are referred to as parameters. Its expression is referred to here as the parameter value. In the medical field of application, basic functions of the human body can be measured by means of so-called vital parameters. Vital parameters are invented According to the example, the heart rate, the blood pressure, the body temperature, the respiratory rate, the oxygen saturation of the blood or the blood flow as a volume flow. Other vital parameters that are continuously measured are, for example, the electrocardiogram (ECG) or the cardiac output (HMV). According to the invention, the sensor can be designed to determine such parameters.

Of the Sensor can be a pressure sensor. Such a pressure sensor can thereby be used to a pressure inside a vessel and / or a pressure difference between two different measuring points and / or between two values measured at different times. As pressure sensors can for example, without limitation to be piezoresistive, piezoelectric, capacitive, inductive Pressure sensors and / or pressure sensors with Hall element can be used. A preferred embodiment a pressure sensor closes a piezocrystal. Such a "piezocrystal" can for Example of quartz, lithium niobate, gallium orthophosphate, berlinite, Minerals of the tourmaline group, Seignette salt, and all ferroelectrics such as barium titanate or lead zirconate titanate. Instead of such Single crystals it is also possible polycrystalline materials such as ceramics. These ceramics can made of synthetic, inorganic, ferroelectric and polycrystalline Ceramic materials are manufactured. Opposite piezoelectric crystals have piezoelectric ceramics such as lead zirconate titanate the advantage much higher piezoelectric coefficient. Advantages of Crystals Quartz, gallium orthophosphate and lithium niobate are higher temperature stability, lower Losses, a much lower hysteresis and a barely existing Creep (ie a delayed Deformation) after change the applied voltage. Furthermore piezoelectric thin layers can also be used as piezo crystals be used. With the help of well-known semiconductor technologies is it possible, for example, to deposit these active piezoelectric thin films on silicon. These are usually zinc oxide or aluminum nitride. Furthermore, for example, the plastic polyvinylidene fluoride polarized and thus be made piezoelectric. A suitable one Piezo crystal can according to the present conditions and the design of the pressure sensor can be optimally selected.

Of the Term "at least a sensor "means according to the invention that the hose one or more sensors, for example, two, three, four, etc. may have sensors. If the hose has multiple sensors has, can this same, that is identical, or different. "Different" means here, that it is possible, for example is that several sensors with the same functional principle at different Place the device with the sensor or sensors arranged are the same measure (eg Pressure or temperature) with the same measuring principle at different To capture measuring points. In addition, it is also possible to use the same measurand, for Example the pressure, with different sensors with different Measuring principles and / or by determining various parameters, for Example pressure and temperature to capture with different sensors. Furthermore, a plurality of parameters (at least two), for example pressure and temperature, measured or determined become. By arranging at least one sensor on the hose according to the invention can physiological or other conditions occurring within the body vessels or -organe prevail, in which the sensor or the hose according to the invention is introduced be recorded.

there the sensor determines parameter values of a patient and directs the obtained data as signals on. The signals can be either already processed in the sensor, for example by electronic circuits in the sensor element, or in shape of raw signals, for example in the form of voltage signals, and by means of or above the device connected to the sensor will be forwarded. An electronic processing of signals already in the sensor element especially useful for weak voltage or current signals be to reduce or avoid signal losses through the line and process stable signals at the other end of the hose to be able to. An integration of electronic circuits in the sensor element is for example in the embodiment of the sensor as a piezo-pressure sensor possible.

On the possible ones Sensors that can be used in the invention will be here only exemplified. A possible oxygen saturation sensor can for example consist of two flexible optical fibers for transmission the measuring signals exist. A possible Flow sensor for measuring the flow velocity and the Volume flow can be configured based on the basics to measure the ultrasound measurement technology.

As a rule, a sensor is positioned in a specific manner in order to be able to measure or determine the corresponding parameters in a suitable manner. It is important to pay attention to various influences and boundary conditions, so that the measured value can be measured as uninfluenced as possible and the measurement signal can be forwarded in a suitable form to a viewer or a recording unit. For this purpose, the sensor is connected in the present invention with the device, which as Guide unit is arranged in the guide lumen. This connection device between sensor and device can be carried out in various ways. The sensor can be integrated directly into the hose. The guide lumen for the device connected to the sensor alone can be used to guide the line - if present - to or from the sensor, and otherwise not appear as a lumen in the sense of a continuous space in appearance or be recognizable. The lines can - if present - be integrated into a material section of the hose.

advantageous Further developments of the invention are the subject of the dependent claims.

So For example, in a preferred embodiment, the tube may be considered intravascular Hose executed become. The tube of this embodiment is suitable for introduction into a blood vessel. Here is the cross-sectional shape and the cross-sectional size of the hose the relevant blood vessel diameter preferably adjusted. In this way it can be prevented that the cross section of the vessel through the inserted hose being so restricted that the blood flow is obstructed. With a narrowing of the cross-section can be relevant parameters change; for example depends on that Blood pressure from the effective flow area. Also, concentration gradients can and change vital signs, if the blood flow changes accordingly, resulting in measurement artifacts can result. Of the hose according to the invention may be configured as an arterial or venous cannula.

In a further preferred embodiment the hose can be designed as a dwell hose. Be live hoses in health, for example, to administer volume and / or in liquid dissolved or suspended medication. Indwelling hoses, for example in the form of cannulas or catheters accomplished and over for a while find a puncture site introduced use.

In Another preferred embodiment the sensor by means of the guide lumen arranged guide means on the Be advanced end of the hose out. The hose end can be in a body vessel, for example into an artery or vein, or into a body cavity, or -opening, for example during arthroscopy. In a puncture of a Vessel can advancing the sensor over the hose end should be advantageous to a largely unadulterated To obtain measurement result: flow influences due to the hose, by material influences or concentration influences can be reduced or completely avoided. This advantage comes especially then to bear, if the hose is used in countercurrent the hose end thus acts as a dynamic pressure element. Then the measured parameter values when advancing over the hose end especially low due to the current influenced measured. This is all the more effective the smaller the sensor in its dimensions is. The device connected to the sensor or the connecting device may be configured as a wire or metal having structure.

In a further preferred embodiment is the tube as a cannula or the like, by what volume - so a fluid, such as saline, HASS, extracorporeally-guided blood the patient, erythrocyte concentrates (EKs) or the like - can be performed. The cannula can be a tubular device in the Be a sense of a rigid hollow cylinder. A rigid cannula has, for example the advantage of having their leadership and the positioning can be done more accurately the volume at a certain point in a body vessel or in a body opening to bring. In addition, a spatial Relation ensured between different lumens of the tube become. This can be known from the field of rigid endoscopes Advantage bring in which the image information through a lens system over a first lumen, while parallel to it in a second Lumen a rinsing fluid led to the object under consideration which ensures a clear image through the lens system. This is in particular due to the immutable position of the lumens to each other possible. The cannula this embodiment However, it can also be configured flexibly with those skilled in the art known advantages.

To the Introducing a corresponding flexible or soft tube according to the invention can even with a comparatively rigid "core" the initial positioning done and removed the core after positioning again to release the lumen. The invention can therefore be a such core, also called "soul", exhibit.

The hose according to the invention can be designed to be self-expandable, for example by means of a shape memory alloy. Advantageously, the smaller access (diameter) for the vascular puncture and the subsequent self-maximization of the passage opening within the vessel Another embodiment may, for example, have a spiral lattice structure which is opened after insertion of the tube by means of a screw movement such that the diameter increases and thus attaches to the vessel wall. During extraction, the lattice structure can be reduced again by means of an opposite rotational movement in the diameter. This serves to protect the fabric during insertion and / or removal of the hose. For this purpose, a diameter change of a few French suffice.

In a further preferred embodiment is over one of the lumens carried a slidable tube. This can be advanced to perform extracorporeal actual measurement or determination, for example, of blood pressure or another value for a corresponding position of the hose according to the invention. So the blood pressure can be measured an extracorporeal water column become. An additional line for flushing the hose with NaCl solution, Water or the like may be provided.

In a further preferred embodiment At least two arbitrary lumens of the hose extend in a longitudinal direction of the hose. In this embodiment For example, a flow and the connected to the sensor Device parallel to one another through the respective lumens and / or executed. The Lumens can each case about the entire length the hose or just over extend a section hereof.

In a further preferred embodiment is the device connected to the sensor or the connecting device as a signal conductor for transmission formed of signals from the sensor. This can be beneficial to this contribute that the hose according to the invention with low dimensions is executable.

In a further preferred embodiment of the hose according to the invention The recorded measured values of the sensor are telemetered to a Recording and / or Transfer processing unit. This has the advantage that, for example, the choice of material with the device connected to the sensor according to criteria other than one good signal forwarding selected can be, for example, the biocompatibility of the material in the form of medical grade polymers, optionally fiber-reinforced for greater stability and rigidity. The telemetrically transmitted sensor signals can transmitted by means of carrier frequencies be, in particular by means of which other signals are not to disturb or disturbed by other signals become.

In a further preferred embodiment is the sensor or the end of the device connected to the sensor equipped with a position sensor to determine the exact position of the To determine sensors. This can have the advantage that collected readings with the position of the sensor can be correlated. Based on the knowledge of the position of the sensor can its Location in the body changed be used to record fair values at defined locations or positions. Knowing the position of the sensor may also be of interest in the evaluation of the signal obtained or parameter value, for example in blood pressure or blood flow.

The transfer the position signals and / or the signals detected by the sensor to an evaluation and output unit can in different ways will be realized. A possibility consists in the application of RFID technology (Radio Frequency Identification), the identification by electromagnetic waves. This application has the advantage that the transponder z. B. in its function as Position signal transmitter no energy supply by means of batteries or similar needed. The transponder receives its energy usually from the reader (evaluation and output unit), the sends an electromagnetic high-energy field to the transponder, which in turn signals, in this case position signals or Sensor measuring signals, outputs.

In a preferred embodiment the hose has an ASIC. The abbreviation "ASIC" here stands for "Application Specific Integrated Circuit "or" application specific integrated circuit "and denotes an implemented as an integrated circuit, electronic Circuit. Unlike universally integrated circuits, like For example, microprocessors in computers, the function of a ASIC given and no longer manipulatable. That's why ASIC realized in the smallest sizes can be, and the production costs can be reduced. The ASIC may preferably be one of the at least one Sensor converted analog signal into a digital signal. To convert an analogue measurement into a digital signal, For example, an integrated into an ASIC Digital Down Converter (DDC) can be used. The converted data can then in appropriately selected, Experts are well-known institutions evaluated.

Of the hose according to the invention can be designed by means of a suitable device to through a spatial approaching a device for reading or receiving a sensor signal related on the sensor whose parameter acquisition and possibly the recording or storage and / or transmission trigger or initiate the collected data or values; or to support.

The determined sensor or parameter values can be stored in a memory device can be stored permanently, but they can also be temporary, for example be stored until their reading out.

The Memory device may be configured such that data or Sensor values immediately after their storage or after a period of time, especially if they are not read after a certain time were overwritten can be preferably similar a loop routine. The attending physician can do so at any time the values of a set period of time, for example the past one two weeks, read.

The Memory device may be configured such that values from Sensor, which before or after a medically relevant, arbitrary definable "event" or circumstance - what happens can be detected at the determined sensor values - be determined or determined are saved.

Of the hose according to the invention can in a preferred embodiment a functional device such as an electrical or optical conductor or the like also integrated in a lumen wall. A such arrangement could with increased Protection of the functional device against damage or functional impairment accompanied. In addition, this can be a manufacturing advantage how to bring reduced manufacturing costs and / or costs with it.

Of the hose according to the invention may, regardless of other features, a means of increasing its Have stiffness. For this he can, for example, a wire mesh or have a spiral of suitable material or augmented with it be.

Further he can advantageously control his position in the body Have marking for detection in an optical process. He can for imaging techniques such as X-rays, Kernspin or the like be detectably marked. The mark may be provided at any portion of the hose. It can be X-ray visible or radiopaque be configured, for example by means of a radiopaque Mark.

Of the hose according to the invention may in one further preferred embodiment of one or more Materials to be made, which in application of imaging techniques no artifacts z. B. in an X-ray or in computed tomography or MRI scans or when examined by means of further imaging methods such as ultrasound revealed. combinations of materials that are involved in a particular imaging process let represent and such, for which does not apply or which at least do not lead to artifacts are for the Device according to the invention also being considered. So can certain sections from a first material, others from one be made second material, wherein z. B. the first material radiopaque can be, the second, however, not.

In a further preferred embodiment The hose of the present invention has a mark the device connected to the sensor or another section or element of the hose. By means of the marking, which, for example. is a centimeter mark, a depth estimate can be made, based on which can be determined how far the hose in a tissue (eg vessel) is introduced.

Of the Hose can in any embodiment for example, one end thereof a plurality of outlet openings for optimizing flow conditions within the tube and / or within a tissue or vessel, in which the tube is inserted is, have.

The inventive task is also solved by an extracorporeal blood circulation set with at least one tube according to the invention with the features of claim 10, and by a device according to claim 11th

In a preferred embodiment the device according to the invention be the measuring signals of the sensor, either as raw data signals or already after an electronic processing, at an output unit, for example, a monitor or a printer, displayed. The user can then directly access the displayed measured values react and, where appropriate, initiate therapeutic measures. The output unit can in addition to a monitor or alternatively also a recording or storage medium or another form of an output unit.

In a further preferred embodiment the device according to the invention can the signals are further processed with a suitable device. This has the advantage that, for example, set alarm limits and be monitored can. Also for proper presentation on a monitor, it may be advantageous be the signals first to further process these in specific units, diagrams or specific software programs suitable for the user.

The signals can be used in a farther Favor th embodiment of the device according to the invention as a basis for a control and / or regulation z. B of extracorporeal blood circulation or other medical device find use. A corresponding, further device can therefore be included in the present invention. Examples include cardiac pumps, heart-lung machines, respiratory or anesthetic devices, and the like.

A Another preferred embodiment of Device according to the invention may include an alarm device. The alarm device may be preferred if a predefined "event" occurs, an alarm signal is output and preferably trigger a visual or audible alarm.

With the hose according to the invention achievable benefits are undiminished even with the extracorporeal invention Blood circulation set achievable. To avoid repetition is on This point therefore referred to their discussion.

By the invention may include determining parameters of a patient in particular their vital parameters, are greatly simplified. By the integration of the device with the sensor in the guide lumen of the hose can separate accesses for sensors, for example about own puncture sites, be avoided. According to the invention, sensors together with the guide lumen and the connection means for purposes beyond the signal measurement used hoses, cannulas, Catheters or the like are integrated. This can be, for example in mobile extracorporeal circulatory systems, especially for patient transport are capable of offering significant benefits.

The Invention is described below with reference to the accompanying drawings with reference to embodiments explained in more detail. In the drawing:

1 shows a simplified perspective view of a 2-lumen tube of a first embodiment of the invention, in which the second, smaller volume is placed on a first circular tube lumen;

2 shows a simplified perspective view of a 2-lumen tube of a second embodiment of the invention, in which the second, smaller volume is integrated into the first circular tube lumen as a segment; and

3 shows a simplified, overall perspective view of a possible embodiment of the device according to the invention with a tubular device, a sensor, a device connected to the sensor, a position receiver and an output unit.

1 shows a 2-lumen tube 1 with a first lumen 3 in which a second, smaller lumen 5 on the first lumen 3 is attached. The first lumen 3 corresponds to a circular cross-section element, as it is often used. For the exemplary application of the tube according to the invention in the context of extracorporeal circulation by a heart-lung machine, a medical grade polymer tube can be used with an inner diameter of 9.5 mm (3/8 inch), the diameter of the tube can also for example, between 12 and 25 French lie. These hoses are usually made by an extrusion process. With regard to the medical grade classification, special requirements for the material, for example regarding toxicity, are guaranteed. The second lumen is configured for receiving a connection device with a sensor.

2 shows a 2-lumen tube 1 in which the second, smaller lumen 5 the circle diameter of the hose 1 divided. This means at unchanged outside diameter of the hose 1 opposite to that of the lumen 3 in that the effective flow area of the larger lumen 3 is reduced compared to the embodiment of 1 , The advantage here is that compared to a design without a second lumen no changes with respect to the outer diameter of the hose 1 to be observed. The disadvantage is the reduced flow cross-section. This disadvantage can be avoided with an overall enlarged outside diameter, in which the flow cross-section is equal to a tube without a second lumen. Such multi-lumen hoses already have applications and related manufacturing methods.

3 shows a possible embodiment of the device according to the invention. The tubular or tubular device 1 is shown here as a rigid tube. A sensor 7 is via a device with a sensor or a connecting device 11 clearly beyond the end 13 pushed out of the tube. On the other end 19 of the tube is symbolically an RFID sensor 21 represented, among other things, by the position of the sensor 7 can be detectable. This RFID sensor 17 can alternatively be attached to another location. Furthermore, more than one RFID sensor may be provided in each embodiment. This advantageously allows a better spatial detection of the hose or sensor position, possibly up to the three-dimensional detection. Furthermore, a leader 23 from the end 19 the management device to a monitor 25 ge leads to output or display the measuring signals. At the same time, a voltage source for supplying the sensors can be provided here.

Claims (14)

Tubular or tubular medical device ( 1 ) with at least one guide lumen ( 5 ) and at least one second lumen ( 3 ), characterized by at least one sensor ( 7 ) for determining parameters of a patient, in particular vital parameters, and one in the guide lumen ( 5 ) ( 11 ), which with the sensor ( 7 ) connected is. Tube ( 1 ) according to claim 1, designed as an intravasal tube. Tube ( 1 ) according to claim 1 or 2, configured as a dwell tube. Tube ( 1 ) according to one of the preceding claims with an end inserted into a body vessel or an opening ( 13 ), whereby the sensor ( 7 ) by means of the device ( 11 ), to which it is connected, via the inserted end ( 13 ) protruding into the vessel or the opening can be introduced. Tube ( 1 ) according to one of the preceding claims, configured as a cannula ( 15 ) for passing volumes. Tube ( 1 ) according to any one of the preceding claims, wherein at least two lumens ( 3 and 5 ) in a longitudinal direction of the hose ( 1 ). Tube ( 1 ) according to any one of the preceding claims, wherein the device ( 11 ), which with the sensor ( 7 ), as a conductor for transmitting signals from the sensor ( 7 ) is configured. Tube ( 1 ) according to one of the preceding claims, comprising a device for the conductorless transmission of signals from the sensor ( 7 ). Tube ( 1 ) according to one of the preceding claims with a device for transmitting signals, the position of the sensor ( 7 ) concerning. Extracorporeal blood circulation set by at least one hose according to one of claims 1 to 9th Contraption ( 17 ) characterized by at least one hose according to claim 1 to 9. Device according to Claim 11, having at least one device for outputting signals from the sensor ( 7 ). Contraption ( 17 ) according to claim 11 or 12 with at least one device for processing signals. Contraption ( 17 ) according to claim 11 to 13, in particular a heart-lung machine, which with at least one hose ( 1 ) according to any one of claims 1 to 9 and / or an extracorporeal blood circulation set according to claim 10.