EP3024531A1 - Revêtement de tuyau pour système médical de conduit en tuyau souple - Google Patents

Revêtement de tuyau pour système médical de conduit en tuyau souple

Info

Publication number
EP3024531A1
EP3024531A1 EP14741615.0A EP14741615A EP3024531A1 EP 3024531 A1 EP3024531 A1 EP 3024531A1 EP 14741615 A EP14741615 A EP 14741615A EP 3024531 A1 EP3024531 A1 EP 3024531A1
Authority
EP
European Patent Office
Prior art keywords
hose
hose cover
top layer
cover according
film
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP14741615.0A
Other languages
German (de)
English (en)
Inventor
John Heppe
Michael-Paul JESTRAM
Axel KORT
Maria MILLAN-GALANTE
Alexander Schrörs
Andreas WÜPPER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Medical Care Deutschland GmbH
Original Assignee
Fresenius Medical Care Deutschland GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fresenius Medical Care Deutschland GmbH filed Critical Fresenius Medical Care Deutschland GmbH
Publication of EP3024531A1 publication Critical patent/EP3024531A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3656—Monitoring patency or flow at connection sites; Detecting disconnections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
    • A61M39/165—Shrouds or protectors for aseptically enclosing the connector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/08—Tubes; Storage means specially adapted therefor
    • A61M2039/087—Tools for handling tubes, e.g. crimping tool for connecting tubes to a connector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1005—Detection of disconnection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1066—Tube connectors; Tube couplings having protection means, e.g. sliding sleeve to protect connector itself, shrouds to protect a needle present in the connector, protective housing, isolating sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production

Definitions

  • the invention relates to a sterile hose cover for a medical
  • Hose line system with which a liquid is supplied to a patient via a hose line and / or a liquid is discharged from the patient, in particular for monitoring the vascular access in an extracorporeal
  • Blood treatment in particular for monitoring vascular access with a central venous catheter for acute or chronic dialysis.
  • the known extracorporeal blood treatment devices include, for example, dialysis devices and cell separators that require access to the patient's vasculature.
  • extracorporeal blood treatment the patient is delivered via an arterial tubing with an arterial
  • Puncture cannula which is returned to the patient via a venous tubing with a venous puncture cannula.
  • a central venous catheter is used on the neck or leg of the patient to create the vascular access.
  • a catheter In the field of chronic dialysis, between 20% and 40% of patients have a catheter as a temporary or permanent vascular access.
  • Luer connection systems are generally used whose connection comprises steep inner and outer cones. These connection systems are referred to as Luer-Lock connections, if the inner and outer cone to secure the connection is extended by a screw thread.
  • Blood treatment devices rely on existing safety devices that trigger an immediate interruption of the extracorporeal blood circulation in case of improper vascular access.
  • WO 99/24145 describes a device for detecting blood, which has a closable with a lid, rigid housing in which a moisture sensor is arranged. To carry out the cannulas and tubing are in the
  • Moisture sensor is relatively expensive to produce in large quantities and is relatively difficult to handle in practice. In addition, a visual inspection is not possible due to the voltage applied to the wall of the housing halves sensors.
  • the invention has for its object to provide a sterile tube cover for a
  • hose line system that is inexpensive in large quantities can be produced.
  • the hose cover according to the invention for a hose line system has at least one flexible pad for supporting a section of at least one hose line and / or a connection system of at least one hose line and at least one flexible top cover for covering the section of the at least one hose line and / or the connection system of the at least one
  • the pad and the topsheet are interconnected such that they form a hinged enclosure for inserting the portion of the at least one tubing and / or the connection system of the at least one tubing, wherein attachment means for releasably connecting the topsheet and the pad to the top and bottom are provided.
  • a flexible layer is to be understood as meaning a piece of material which is not rigid but elastically deformable.
  • the piece of material can be very flexible, depending on the material properties, so that it is the outer one
  • the hinged enclosure can be quickly and safely attached to a portion of the tubing, especially in the region of the connection system of the tubing without further aids.
  • the sheath can be easily attached in the region of a connection system, for example a luer lock connection system, which connects a central venous catheter for acute dialysis with one or more hose lines.
  • a connection system for example a luer lock connection system, which connects a central venous catheter for acute dialysis with one or more hose lines.
  • the sheath may be easily removed from the tubing or connection system during and / or after treatment, which is particularly important when used with a central venous catheter.
  • connection system or the skin of the patient. This will be the
  • a particularly preferred embodiment provides that the upper and lower layers consist of two separate pieces of material, which are connected to one another on one side, in particular welded or glued. If different materials are to be applied to the top and bottom, this results
  • the tube cover is made of a single piece of material, a portion of which is the topsheet and a portion is the pad, with the underside of the topsheet lying on top of the pad when the sleeve is collapsed.
  • the hinged enclosure can therefore be produced inexpensively in large numbers by a simple folding of a single piece of material.
  • a superior aspect of the invention is to provide with the sterile hose cover protection of a connection system from external influences, in particular a protection of a Luer or Luer-Lock connection system, for example against the ingress of germs (splash guard). This eliminates the hitherto usual covering the hose connection with a sterile cloth.
  • a particular aspect of the invention is the monitoring of a patient access, in particular a vascular access in an extracorporeal blood treatment, in particular a vascular access with a central venous catheter for acute or chronic dialysis.
  • a preferred embodiment of the cover according to the invention provides a
  • Moisture sensor with the leakage of liquid, especially blood can be detected safely.
  • monitoring of patient access can also be done by visual inspection when the topsheet is transparent.
  • the tube cover may have both a moisture sensor and a transparent top layer, so that in addition to the detection of the leakage of blood with the moisture sensor and an additional visual inspection is possible.
  • the monitoring without humidity sensor can be done only by visual inspection if the top layer is transparent.
  • the tube cover according to the invention also permits the detection of a slow blood loss, for example as a result of handling
  • the pad has an absorbent material for absorbing liquid exiting the connection system.
  • the pad is a composite of an absorbent, preferably textile material, and a film, wherein the film on the outside of the hose cover and the absorbent material are arranged on the inside of the hose cover.
  • Moisture sensor is achieved with the absorbent material that attaches to the
  • Hose connection provides escaping blood directly to the moisture sensor arrives. This increases the overall sensitivity. Consequently, a can also
  • possibly lower cost sensor may be used with a design lower sensitivity. It is avoided with the absorbent material covering film that blood from a wound or due to a leak of the
  • the humidity sensor is preferably an electrical humidity sensor having an electrically conductive structure.
  • the electrically conductive structure of the moisture sensor is embedded in the liquid-absorbent layer or applied to the absorbent layer.
  • the electrically conductive structure does not need to extend over the entire surface of the absorbent layer, because due to the absorbency of the layer, the detection of liquid in a portion of the surface is sufficient.
  • the electrically conductive structure may comprise one or more conductor tracks, which extends in several sections over at least a portion of the pad. It can also be provided on the top layer.
  • the absorbent material for embedding the electrically conductive structure is a textile material.
  • the textile material is a non-conductive warp and non-conductive fabric
  • Weft threads and conductive warp threads and conductive weft threads which are arranged such that the electrically conductive structure is formed in the fabric.
  • the tube cover can thus be produced in a weaving process without large production engineering effort in large quantities particularly cost. You can still cut and sterilized without great technical effort and as Disposable sensor are provided sterile in a suitable packaging.
  • Such a fabric with an electrically conductive structure is described in detail in WO 2011/116943.
  • connection For electrical contacting of the moisture sensor, the hose cover on connection contacts, which at the end of an elongated portion of the
  • Hose cover are formed, which is connected to the top layer or pad. This ensures that the connection contacts are spatially separated from the humidity sensor. Therefore, unlike the area where the humidity sensor is located, the area of electrical contact need not be sterile. This is particularly advantageous if the terminal to be connected in the region of the electrical contact and / or the connection cable are not sterilized and are provided in particular for multiple use. This is particularly advantageous in the monitoring of central venous catheters.
  • connection contacts depends on the design of the
  • the humidity sensor may be two
  • Connection contacts may be provided. Instead of a connecting lug with
  • Connection contacts for a connector of an electrical connection line it is also possible to lead out a connection line from the device according to the invention.
  • the desired flexibility of the ply can be adjusted by selecting a suitable film with a corresponding stiffness.
  • the respective layer is given sufficient stability with the film, but without losing the required flexibility.
  • the attachment means for releasably connecting the upper and lower layer, with a view to avoiding a risk to the patient by slipping out of the Catheter be designed differently.
  • the hose cover fasteners should open so that the cover is pulled off with the cable without exerting any appreciable tensile load on the hose or connection system.
  • a tensile load on the hose cover which may include a moisture sensor, also no significant tensile load should be exercised.
  • a preferred embodiment provides at least one surface provided with an adhesive or adhesion layer, preferably a strip provided with an adhesive or adhesion layer, for the reversible and repeated bonding of the upper and lower layers to the upper side of the base and / or the underside of the upper layer.
  • the hook and loop fasteners each have two elements that can be releasably connected to each other. While one element has a loop layer, the other element has a hook layer which reversibly hooks against the loop layer during pressing.
  • the two elements of the hook and loop fastener are preferably strips.
  • the fastening means have at least one tab provided on the top sheet for insertion into a recess provided on the base.
  • the tab can also be provided on the pad and the recess on the top layer.
  • the hose cover has at least one push button, which has a closure part provided with a button on the upper layer and a closure part with a depression provided on the base, wherein the button can be pressed into the depression in a latching manner.
  • the closure part with the button can also be provided on the base and the closure part with the recess on the top layer.
  • the button and / or the recess of the push button can be made by deep drawing the top or bottom.
  • the fastening means have at least one fold provided on the base for clamping the upper layer or at least one fold provided on the upper layer for clamping the pad to be clamped. With sufficient flexibility of the layers, this embodiment requires a certain rigidity, in particular of the top layer, which is preferably clamped into the fold in a snap-fit manner. The required stiffness can be adjusted in the composite of textile material and film by selecting suitable materials.
  • the upper layer and / or pad in a particularly preferred embodiment, at least one incision for receiving a portion of the hose.
  • the incision advantageously has a slot for insertion of the tubing, to which a recess for clamping receiving a portion of the tubing connects.
  • Embodiment provides an insert, which has at least one clamping part for clamping attachment of a portion of the hose.
  • the hose cover can differentiate the hose lines
  • tubing systems together with the associated connection systems, for example, the tubing or connection systems of single-lumen catheters, double-lumen catheters or Tesio catheters.
  • One or two hose lines or connection systems can be accommodated in a covering.
  • the tube cover has a first rectangular envelope and a second rectangular envelope, wherein the first envelope and the second envelope are connected to each other with a connecting tab.
  • the connecting strap is advantageously again a composite of a textile material and a film.
  • the connection tab has greater flexibility than the enclosure, which can be adjusted again by selecting a suitable foil.
  • 1A is a simplified schematic representation of a first embodiment of the unfolded sterile tube cover in plan view
  • Fig. IC is a section through the folded tube cover of FIG.
  • FIG. 2 shows the essential components of a blood treatment device having a device for monitoring a vascular access
  • 3A to 3C is a simplified schematic representation of an alternative
  • 4A to 4F show different embodiments of incisions in the upper or lower layer of the hose cover for clamping fixation of the hose lines
  • FIG. 5A shows another embodiment of the hose cover
  • hose cover 8 shows a further embodiment of the hose cover
  • Fig. 9 shows another embodiment of the hose cover
  • Fig. 10 shows another embodiment of the hose cover.
  • connection systems in particular Luer-Lock connection systems, for connecting tubing, in particular tubing of a central venous catheter for acute dialysis, against the penetration of germs, for example, prior to droplet infection.
  • FIGS 1A and 1B show an embodiment of the invention
  • the sterile tube cover intended especially for a central venous catheter in acute or chronic dialysis.
  • the sterile tube cover is made of a single piece of material 1, which is cut from a material web, or made of a piece of material composite piece, wherein the sections are each cut from a web.
  • the piece of material 1 is a composite of an absorbent material 1A, in particular textile material, for example a fabric, and a film 1B, which is not permeable to liquid.
  • the film 1B is on the outside and the fabric 1A on the inside of the folded cover.
  • the piece of material 1 has a substantially rectangular blank.
  • the longitudinal sides are denoted by 2 and the narrow sides by 3.
  • On the narrow sides 3 of the material blank are each a gripping tab 4.
  • the grip tabs 4 on the narrow sides 3 are
  • the substantially rectangular piece of material 1 is folded in such a way that the
  • Enclosure 5 releasable fastening means 8 are provided, which in principle
  • the fastening means 8 are provided with an adhesive or adhesion layer surfaces 8A, which are provided on the top and / or bottom.
  • the surfaces 8A are preferably along the longitudinal and narrow sides 2, 3 at the edges of the piece of material extending strips, so that the sheath 5 can be completely closed.
  • the adhesive or adhesion strips 8A are designed such that the cover can be securely closed and on the other hand can be easily opened.
  • the tubing can be easily lead out of the enclosure 5 at different locations, so that the enclosure can adapt to the course of the tubes.
  • the envelope is closed with the adhesive or adhesive strips 8A, wherein the top and / or bottom 7, 6 fit tightly against the hoses, so that the risk of the ingress of germs is low.
  • a cover of the Luer-Lock connections with a sterile cloth omitted or the protection is improved.
  • a particular aspect of the invention is the monitoring of the luer-lock connections of the central venous catheter on the leakage of blood.
  • the film 1B of the material composite is a transparent film which is a permanent one
  • the film is preferably made of LDPE (Low Density Polyethylene).
  • the absorbent material 1A of the composite material has a light color, in particular, the absorbent material is a white tissue, so that blood absorbed by the tissue can be easily recognized by the transparent foil 1B.
  • the film 1B may also be a non-transparent film which is not permeable to liquid. It may also be provided only on the top layer 7 a transparent film.
  • Hose cover described that allow detection of the leakage of blood with a moisture sensor. These embodiments are connected to a device for monitoring a vascular access, which forms part of a
  • FIG. 2 shows the essential components of a blood treatment device, in particular hemodialysis device A for acute dialysis or chronic dialysis, which has a device B for monitoring a vascular access, in particular a vascular access with a central venous catheter.
  • a blood treatment device in particular hemodialysis device A for acute dialysis or chronic dialysis
  • a device B for monitoring a vascular access in particular a vascular access with a central venous catheter.
  • Hemodialysis apparatus A First, the dialysis apparatus will be described.
  • the hemodialysis apparatus A has a dialyzer 9, which passes through a
  • the semipermeable membrane 10 is divided into a blood chamber 11 and a dialysis fluid chamber 12.
  • the vascular access to the patient is carried out with a central venous catheter 13, which is connected to the neck of the patient.
  • the central venous catheter 13 is part of the extracorporeal blood circulation I, which is only hinted at, which encloses the blood chamber 11 of the dialyzer 9 and comprises tubing lines 14, 15.
  • a blood pump 16 is provided to convey the blood in the extracorporeal circuit.
  • the dialysis fluid circuit II of the dialysis machine A comprises a
  • a dialysis fluid discharge line 19 leaves, which leads to an outlet 20.
  • Dialysis fluid removal 19 is a dialysis fluid 21 connected.
  • the control of the dialysis device takes over a central control unit 22 which controls the blood and Dialysiersammlungspumpe 16, 21 via control lines 23, 24.
  • the central control unit 22 is connected via a data line 25 to an alarm unit 26, which gives an optical and / or acoustic and / or tactile alarm in the event of a malfunction.
  • the monitoring device S B has an evaluation device 29, which is connected via a connecting line 30 with the hose cover C according to the invention, which is arranged at the hose connection point 31.
  • the connecting line 30 is connected to an electrical connector 32 to those in Fig. 2, not shown
  • the evaluation device 29 is connected to the central control unit 22 of the dialysis machine A. In the event that blood from the
  • Monitoring device B a control signal that receives the central control unit 22, which performs an intervention in the blood treatment.
  • the central control unit 22 stops the blood pump 16 and generates an alarm signal, so that the alarm unit 26 gives an audible and / or visual and / or tactile alarm.
  • Hose cover differs from the embodiment described with reference to FIGS. 1A to 1C essentially in the fact that a moisture sensor 34 is embedded in the absorbent material 1A, which is attached to the Monitoring device B is connected.
  • the corresponding parts are provided in the figures with the same reference numerals.
  • FIGS. 3A to 3C show a first exemplary embodiment of a hose cover C with a moisture sensor 34.
  • the tube cover is made of a single piece of material or a piece of material 1 composed of two sections, the single piece of material or sections being respectively cut from a web of material which is a composite of absorbent fabric 1A and liquid-impermeable film 1B ,
  • the film 1B is on the outside and the fabric 1A on the inside of the folded cover.
  • the film and the fabric may consist of individual sections with different material properties.
  • the piece of material 1 has a first
  • a hinged enclosure 5 with a base 6 for laying a luer-lock connection and a top layer 7 for covering the luer-lock connection which together with the associated hose line section Envelope can be inserted.
  • the piece of material 1 has a second, elongated portion which serves as a connecting plate 35, which is connected in the present embodiment with the pad 6, but may also be attached to the top layer 7. At the end of the terminal lug, the electrical contact is made with the connector 32 of the monitoring device B.
  • the releasable fastening means 8 for connecting the top layer 7 and the base 6 or for closing the envelope 5 have in the present
  • Embodiment provided on the outer side of the upper layer Fixing tab 8B and provided on the outer side of the pad 6 recess 8C.
  • the tab 8A is provided with lateral slots 8D and the recess IC with lateral undercuts 8E, so that the tab is captively but easily detachably secured in the recess.
  • a recess may also be provided a slot.
  • a gripping tab 4 for opening the cover.
  • FIG. 3B shows the Luer-Lock connections 27 lying next to one another between the upper and lower layers 7, 6, which are enclosed by the sheath 5.
  • the moisture sensor 34 is embedded in the absorbent fabric 1A of the composite material, which consists of electrically conductive and electrically non-conductive warp and weft threads.
  • the non-conductive warp yarns and non-conductive weft yarns as well as conductive warp yarns and conductive weft yarns are arranged such that an electrically conductive structure is formed in the fabric 1A, which forms the
  • Moisture sensor 34 forms. Such a fabric with an electrically conductive structure is described in detail in WO 2011/116943, to which reference is expressly made.
  • FIG. 3C shows the conductor track sections 34A, 34B of the electrically conductive structure which are orthogonal to one another.
  • the crossing points 34 C at which the orthogonally extending warp and weft threads in the tissue contact electrically, are marked with a circle.
  • a portion of the conductor track portions 34A, 34B lead to the end of the terminal tab 35, wherein the terminal contacts 35A for the connector 32 (FIG. 2) of the monitoring device B at the ends of
  • Track sections 34 B are formed.
  • the film 1B of the composite material can impart sufficient rigidity to the material, which is not given by the fabric 1A alone. If the film 1B consists of several sections of different stiffness, individual sections The casing 5 also have a different flexibility. Preferably, the terminal tab 35 has a greater flexibility, wherein the film 1B in the region of
  • Terminal tab is stiffer and / or thicker than in the region of the substantially rectangular portion in which the film is thinner and / or more flexible.
  • the film 1B is laminated with the fabric 1A.
  • the composite of film and fabric is thermally deformed such that the enclosure 5 is biased in the folded state.
  • the composite of film and fabric is elastically deformed against the bias, in particular in the region of the fold 36. In the area of the fold 36 can be
  • Luer-Lock connections 27 or the associated hose lines 27C can already be sufficiently fixed in the sheath 5 by the bias of the upper and lower layers 7, 6 alone. However, a preferred embodiment provides an additional fixation of the hose lines 27C in the enclosure 5. To fix the
  • Hose lines are provided on the base 6 cuts 37, which are preferably arranged on both sides of the connecting plate 35. They each have a slot 37A into which the hose line sections 27A can be inserted laterally. The slot 37A is followed by a recess 37B for receiving the
  • Hose line section 27C which can be clamped in the recess.
  • the cuts 37 may also be provided on the top layer 7.
  • the arrangement of the notches 37 on both sides of the terminal tab 35 has the advantage that the slots 37A can be easily opened by lifting the terminal tab 35, thereby facilitating the insertion of the tubing.
  • FIGS. 4A to 4F show different embodiments of the notches 37 on the casing 5.
  • Fig. 4A shows an embodiment in which the slits 37A are inclined to the lower side edge of the base 6. This will be both a secure stop and a easy insertion of the hose lines 27 A guaranteed.
  • Fig. 4B shows a
  • FIG. 4C shows an embodiment with a slot 37A having two sections perpendicular to each other. This slot has a larger width than the other slots and forms an insertion channel, in which the hose lines can be easily inserted and provides a secure grip.
  • Fig. 4D shows the embodiment as in the embodiment of Figures 3A to 3C.
  • Fig. 4E shows a
  • FIG. 4F shows an embodiment in which the slots 37A have a portion perpendicular to the lower side edge and a side edge inclined portion, whereby the hose lines can be easily inserted and a secure hold is ensured.
  • Recesses is dimensioned such that the hose lines 27C are clamped.
  • Fig. 5 shows a further embodiment of the hose cover according to the invention.
  • the hose cover of Fig. 5 differs from the hose cover of Figures 3A to 3C by the different arrangement of the tracks 34A, 34, B and the different configuration of the terminal tab 35 and the slots 37 for receiving the hose lines and the shape and dimensions.
  • the corresponding parts are again provided with the same reference numerals.
  • Terminal tab 35 of the embodiment of Fig. 5 is connected to the top layer 7 and extends parallel to the longitudinal side of the top layer beyond the top layer, wherein the terminal tab to the top layer in the region of the connection between upper and
  • the hose cover has on the base 6 via cuts 37 for receiving the hose lines, which are designed differently.
  • the cuts 37 differ in the diameter of the circular recesses 37B. However, it is also possible to provide the cuts shown in FIGS. 4A to 4F.
  • the different design of the incisions 37 allows the clamping fixation of the various blood tube systems, which include, for example, single-lumen or double-lumen catheter.
  • the incisions 37 are formed such that at a greater tensile force, the tube cover can be detached from the blood tube system.
  • the piece of material 1 of the hose cover can basically consist of different materials. It can be achieved by selecting suitable materials, whether the top and
  • Pad 7, 6 are resiliently biased in the folded position of the hose cover.
  • the resilient bias is determined by the material properties.
  • Figures 6A to 6C show a further embodiment of the hose cover according to the invention, which has two sheaths 5, each of which can accommodate one or two connection systems together with the associated hose line sections.
  • the formation of the two sheaths 5, each having a top and bottom layer 7, 6, corresponds to the envelope of Figures 3A to 3C.
  • the corresponding parts are again provided with the same reference numerals.
  • the first and second sheath 5 are connected to each other with a connecting tab 38, the ends of which are connected to the opposite narrow sides of the
  • the hose cover is again made of a piece of material 1, which is a composite of an absorbent material 1A and a film 1B.
  • a film 1B which has a lower rigidity, with the
  • FIG. 6C shows the tracks 34A, 34B of the humidity sensor 34.
  • FIGS. 7A to 7D show a further embodiment of the hose cover according to the invention.
  • the hose cover of FIGS. 7A to 7D does not have a fastening tab on the top sheet that is inserted into a recess on the backing, but a fold 39 provided on the base 6 for clamping the top sheet 7.
  • the seam 39 on the backing 6 runs along its longitudinal edge.
  • the piece of material 1 has sufficient rigidity in order to be able to fix the upper layer 7 in a clamping manner (FIG. 7D). With sufficient rigidity of the top layer 7, the required clamping force is achieved.
  • the top layer is preferably wider than the base 6, so that the top layer 7 bulge outwards and thus sufficient space for the hose (s) can be created.
  • the envelope 5 is closed with an adhesive or adhesion strip 8A, which can be provided in one or both narrow sides of the top or bottom layer 7, 6.
  • an adhesive or adhesion strip 8A which can be provided in one or both narrow sides of the top or bottom layer 7, 6.
  • a hook and loop fastener is provided only on one of the two narrow sides.
  • Fig. 7E shows an embodiment of the insert 40 in a perspective view.
  • Fig. 7D shows an alternative embodiment in a sectional view.
  • the insert 40 of Fig. 7E has a frame 40 A with two juxtaposed clamping parts 40 B, 40 C, in which the hose line sections 27 A be held clamped.
  • the insert part of FIG. 7D has a clamping part 4D with two recesses 40E, 40F for clamping the two hose lines 27A.
  • the connecting tab 35 extends in the embodiment of Figures 7A to 7D parallel to the longitudinal side of the top layer 7 beyond the top layer addition.
  • Fig. 8 shows a further embodiment of the folded
  • Hose cover in plan view.
  • the hose cover of FIG. 8 has a gripping tab 4 provided in the upper layer 7, on the underside of which there is a closure part 8D with only a hint of closure with a button which can be pressed into the recess 6 in a recess 8E.
  • the two closure parts of the push button can be made of metal or plastic and connected to the piece of material 1. But it is also possible to form a button and a recess on the top or bottom layer by a permanent deformation (deep drawing) of the film 1B.
  • Figures 9 and 10 show alternative embodiments of the hose cover, which are not made of a one-piece piece of material, but of two sections, which are connected to a single piece of material. The each other
  • the 9 is made of a piece of material 1 composed of two parts 1 ', 1 ", wherein the parts are each cut from a material web
  • the material web is a transparent film web, in particular a film made of LDPE (Low Density Polyethylene)
  • the first part 1 ' forms the top layer 7 and the second part the cover 6.
  • the two parts 1' 1 are joined together on one side.
  • Reference numeral 41 denotes. In the present embodiment, both sections 1 ', 1 "have a substantially rectangular blank.
  • the connecting means 8 for connecting the top layer 7 and the base 6 or for closing the envelope 5 are in the present embodiment
  • Velcro closures in particular micro-Velcro closures, each consisting of two
  • One strip 8 ' has a hook layer and the other strip 8' 'has a loop layer
  • the strips 8' with the hook layer are located on the upper side of the base 6 and the strips 8 "with the loop layer on the underside of the top layer 7. They run along the edges of the two layers 6, 7.
  • a piece of material 1A made of an absorbent material is applied, which has the above-described in Fig. 9 only schematically illustrated moisture sensor 34, which is formed as an electrically conductive structure.
  • the absorbent piece of material 1A extends to the strips of the hook and loop fastener, wherein the connecting tab 35 on the pad 6 addition to one side of the
  • Hose cover extends to the outside. Since the strips 8 "of the hook-and-loop fastener 8 with the loop layer are located on the underside of the top layer 7, the hook-and-loop fastener strips can not get caught on the absorbent piece of material 1A.
  • Fig. 10 shows an embodiment which differs from the embodiment of Fig. 9 in that the absorbent piece of material 1A is not a
  • the absorbent material may be a hydrophilic nonwoven which should be low in particle size and sterilizable.
  • the strips 8 "of the hook and loop fastener 8 are applied to the loop layer at a predetermined distance from each other, while on a second material web, in particular film web, the strip 8 'of the hook and loop fastener 8 are applied to the hook layer at a predetermined distance from each other.
  • the Velcro strips can be strips provided with an adhesive or adhesive layer which are glued to the film webs.
  • pieces of material 1A made of absorbent material which have a
  • Moisture sensor 34 (FIG. 9) or not having a moisture sensor (FIG. 10) is applied. Subsequently, the first portions 1 'of the first material web and the second portions 1' 'separated from the second material web. The two sections 1 ', 1 "are then connected to each other to form a single piece of material 1.
  • the pieces of film are preferably welded to one side, whereupon the individual pieces of material 1 are folded such that the underside of the top layer 7 lies on top of the base 6
  • the individual tube covers are sterilized and then packaged, but they can also be packaged and then sterilized, and it is also possible to package the unfolded tube covers.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Pulmonology (AREA)
  • Epidemiology (AREA)
  • Cardiology (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne un revêtement de tuyau destiné à un système de conduit en tuyau souple, notamment pour la surveillance d'une intervention sur des vaisseaux pour un traitement extracorporel du sang. Le revêtement de tuyau de l'invention comprend au moins une couche inférieure flexible (6) destinée à supporter une portion d'au moins un conduit en tuyau souple et/ou un système de raccordement d'au moins un conduit en tuyau souple et au moins une couche supérieure flexible (7) destinée à recouvrir la portion de l'au moins un conduit en tuyau souple et/ou le système de raccordement de l'au moins un conduit en tuyau souple. La couche inférieure (6) et la couche supérieure (7) sont reliées entre elles de façon à former une gaine repliable (5) pour l'insertion de la portion d'au moins un conduit en tuyau souple et/ou du système de raccordement de l'au moins un conduit en tuyau souple. Des moyens de fixation (8) sont prévus sur la couche supérieure et la couche inférieure pour relier de façon amovible la couche supérieure et la couche inférieure. Selon un aspect particulier de l'invention, le revêtement de tuyau de l'invention est pourvu d'une protection contre les influences extérieures, notamment les germes. Un aspect particulier de l'invention est la surveillance de l'intervention sur un patient, notamment en ce qui concerne la perte de sang, qui peut être effectuée au moyen d'un capteur d'humidité (34) placé dans le revêtement de tuyau et/ou par inspection visuelle.
EP14741615.0A 2013-07-25 2014-07-18 Revêtement de tuyau pour système médical de conduit en tuyau souple Withdrawn EP3024531A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102013012365.8A DE102013012365B4 (de) 2013-07-25 2013-07-25 Sterile Schlauchabdeckung für ein medizinisches Schlauchleitungssystem
PCT/EP2014/065564 WO2015011065A1 (fr) 2013-07-25 2014-07-18 Revêtement de tuyau pour système médical de conduit en tuyau souple

Publications (1)

Publication Number Publication Date
EP3024531A1 true EP3024531A1 (fr) 2016-06-01

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EP14741615.0A Withdrawn EP3024531A1 (fr) 2013-07-25 2014-07-18 Revêtement de tuyau pour système médical de conduit en tuyau souple

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US (1) US10314964B2 (fr)
EP (1) EP3024531A1 (fr)
CN (1) CN105517622A (fr)
DE (1) DE102013012365B4 (fr)
WO (1) WO2015011065A1 (fr)

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US10617809B2 (en) 2015-12-29 2020-04-14 Fresenius Medical Care Holdings, Inc. Electrical sensor for fluids
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EP3512580B1 (fr) * 2016-09-16 2023-06-07 Redsense Medical AB Dispositif de surveillance de raccords de tuyaux et de fuite de fluide corporel
DE102016013334B3 (de) * 2016-11-10 2018-04-05 Fresenius Medical Care Deutschland Gmbh Medizinisches Gerät mit einem Verbindungsstück für die Herstellung einer Flüssigkeitsverbindung zwischen flüssigkeitsführenden Leitungen
GB201808826D0 (en) * 2018-05-30 2018-07-11 Ge Healthcare Bio Sciences Ab Connector for aseptic connection, and method for connecting and disconnecting such connectors
GB201819185D0 (en) 2018-11-26 2019-01-09 Royal Liverpool & Broadgreen Univ Securement device for an endotracheal tube
JP7244714B1 (ja) 2022-07-14 2023-03-23 健太 西堀 医療用チューブ保護具

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Also Published As

Publication number Publication date
DE102013012365A1 (de) 2015-02-19
DE102013012365B4 (de) 2019-06-13
US20160166756A1 (en) 2016-06-16
CN105517622A (zh) 2016-04-20
US10314964B2 (en) 2019-06-11
WO2015011065A1 (fr) 2015-01-29

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