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WO2014118172A1 - Cathéter muni d'un système de positionnement - Google Patents

Cathéter muni d'un système de positionnement Download PDF

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Publication number
WO2014118172A1
WO2014118172A1 PCT/EP2014/051625 EP2014051625W WO2014118172A1 WO 2014118172 A1 WO2014118172 A1 WO 2014118172A1 EP 2014051625 W EP2014051625 W EP 2014051625W WO 2014118172 A1 WO2014118172 A1 WO 2014118172A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
guide wire
channel
manipulation device
piston
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.)
Ceased
Application number
PCT/EP2014/051625
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German (de)
English (en)
Inventor
Dietmar Enk
Sebastian ENK
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.)
Ventinova Medical BV
Original Assignee
Ventinova Medical BV
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 Ventinova Medical BV filed Critical Ventinova Medical BV
Publication of WO2014118172A1 publication Critical patent/WO2014118172A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0488—Mouthpieces; Means for guiding, securing or introducing the tubes
    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0402—Special features for tracheal tubes not otherwise provided for
    • A61M16/0404—Special features for tracheal tubes not otherwise provided for with means for selective or partial lung respiration
    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0402—Special features for tracheal tubes not otherwise provided for
    • A61M16/0418—Special features for tracheal tubes not otherwise provided for with integrated means for changing the degree of curvature, e.g. for easy intubation
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09116—Design of handles or shafts or gripping surfaces thereof for manipulating guide wires
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0227—Materials having sensing or indicating function, e.g. indicating a pressure increase
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A61M2205/584—Means for facilitating use, e.g. by people with impaired vision by visual feedback having a color code
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/587—Lighting arrangements
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6063—Optical identification systems
    • A61M2205/6081—Colour codes
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • the present invention relates to a catheter, in particular a so-called bronchus blocker, which can be positioned for treatment and / or diagnosis at specific locations in a cavity system of a body and a method for positioning the catheter.
  • a known approach in the positioning of a catheter is to use as an aid an endoscope (eg a flexible fiber optic), the front end of which, when advancing in a cavity system, at least partially illuminates and images it, and possibly relatively well through a movable front segment a desired position can be advanced.
  • a catheter carried by the endoscope or a catheter introduced via or through the endoscope can thus be brought into a desired position.
  • endoscope eg a flexible fiber optic
  • One of the essential ideas of the present invention is therefore to be able to move a catheter independently of an endoscope and to be able to precisely position its tip, wherein this movement can be monitored and tracked by a distance-guided endoscope.
  • Interventions in the thorax for example and in particular at the lungs, often require a so-called one-lung ventilation, ie the respiration of the anaesthetized patient then takes place only via the lungs of the non-operated side.
  • the lung of the site to be operated is then functionally switched off for ventilation.
  • a bronchus blocker In contrast to the double-volume tube, in which one respiratory lumen leads to the left and the other to the right lung, a bronchus blocker does not have a ventilation lumen, but at most a small lumen through which air can be sucked out of the switched-off lung.
  • the lung In both the double-lumen and the bronchial blocker, the lung (s) are closed by means of an inflatable balloon (also called a cuff).
  • an inflatable balloon also called a cuff.
  • the lung of the operated side By inflating the cuff of the bronchial blocker, however, the lung of the operated side is completed; the ventilation of the opposite side then takes place via a conventional respiratory tube, next to or in which the bronchial blocker is located. Interventions in the thorax and in particular on the lung not only require the elimination of ventilation of the side to be operated, but also the most complete collapse of the lung.
  • double-lumen tubes generally allow a faster ventilation and thus a better collapse of the lungs on the side to be operated on.
  • double lumen tubes are relatively traumatic and should therefore only be placed as long as necessary. Umintubation of the patient to a conventional breathing tube is always necessary if the patient is already ventilated or must remain ventilated after the procedure. Due to the necessarily small outer diameter of children, double lumen tubes are also not available in pediatric sizes as the two ventilation lumens would simply be too small.
  • Bronchus blockers have the disadvantage that the venting of the lung takes longer on the side to be operated on and the collapse of the lung only becomes complete through gas absorption, thus typically requiring more time. But you can with a bronchus blocker but more easily adapt to the individual situation. Umintubation of the patient is (almost) always unnecessary as the blocker can be advanced through a recumbent conventional breathing tube and withdrawn after removal of one-lung ventilation. This is an important advantage, especially in critically ill patients with markedly reduced lung function or in patients with difficult airway conditions.
  • Bronchial blockers are also available in sizes suitable for (small) children and not only allow (like double-lumen tubes) the one-lung ventilation of the left or right lung, but also in principle a selective blockade of individual lung lobes or peripheral lung sections.
  • the gold standard with regard to left-right and depth positioning or position control of both double-lumen tubes and bronchial blockers is flexible (fiber) endoscopy. While a double-lumen sub- stance is typically first blindly advanced and subsequently the position is checked by means of an endoscope (eg a flexible fiber optic) and, if necessary, corrected under vision, a bron- chus blocker is positioned exclusively under endoscopic / fiber optic control.
  • an endoscope eg a flexible fiber optic
  • the Arndt Endobronchial Blocker is a more flexible system in this regard and even allows one-lung ventilation for children under one year old.
  • the Arndt Endobronchial Blocker has a nylon thread in the central channel. the one that sticks out as a noose at the top.
  • the blocker at the tip of the endoscope eg a flexible fiber optic
  • the blocker is then taken along with the advancement of the endoscope, brought to the desired position with the endoscope and then pushed off the endoscope.
  • this blocker guided through the sling can also be lowered down and into the desired position on the endoscope (eg a flexible fiber optic).
  • a special so-called multi-port adapter attached to the tube offers separate access for the bronchus blocker and the endoscope (eg a flexible fiber optic) and also allows the connection of the ventilation system.
  • the Arndt system also has disadvantages: Due to the principle, the blocker and the endoscope (eg a flexible fiber optic) must be brought together to the desired location in the bronchial system. The forward or deporting of the blocker from the endoscope happens blindly and once deported from the endoscope, the blocker is initially no longer controllable. The necessary to reposition the lying blocker receiving the loop with the endoscope is often difficult and requires some practice. However, once the loop has become too small due to retraction or the nylon thread has been pulled out of the blocker (which is usually necessary for optimum ventilation of the lung), it is impossible, at least for the smaller sizes of the Arndt Endobronchial Blocker Advance nylon thread again. The blocker is then no longer taxable or feasible.
  • the blocker and the endoscope eg a flexible fiber optic
  • the disadvantages or limitations of the Arndt system address the idea, initially via the working channel of the endoscope (eg a flexible fiber optic cable). optics) to push an oversized (140 cm) guide wire to the desired location, then remove the endoscope, then thread the bronchus blocker (after pulling out the nylon thread) onto the guide wire, advance over it, and then pass the blocker under endoscopic / fiber optic control (the Sebanek JJ et al: Placement of an Endoscopic Blocker Using a Seiding Technique in a Patient with Left Mainstem Bronchial Compression (Abstract), Society for Airway Management, 16th Scientific Meeting. Toronto, 21.-23.9.2012].
  • the Sebanek JJ et al Placement of an Endoscopic Blocker Using a Seiding Technique in a Patient with Left Mainstem Bronchial Compression (Abstract), Society for Airway Management, 16th Scientific Meeting. Toronto, 21.-23.9.2012.
  • the main drawback of this approach is the (sterile) handling of a (necessarily) overly long guidewire, which must be held blind in the correct position, while the endoscope (eg, a flexible fiber optic) is pulled back over the guidewire, reinserted through the tube, and then the bronchus blocker is threaded onto the guidewire and advanced.
  • endoscope eg, a flexible fiber optic
  • bronchus blocking systems and techniques have specific disadvantages or limitations. It is desirable to have a system that provides an optimal view of the working area, at the same time allowing a sensitive and targeted control or a quick and precise (re-) positioning of the bronchial obstructer and also ensuring the best possible ventilation of the lung.
  • a catheter having upper and lower ends and at least one first channel connecting both ends, and a positioning system for positioning the lower end in a cavity system of a human body.
  • the positioning system comprises the following elements:
  • a guide wire which can be inserted and removed in a translatory manner, ie axially, and rotationally movably, and which is at least so long that a first subregion of the guide wire can be pushed out of the first channel at the lower end, while a second subregion always extends at least partially sticking out of the catheter at the top,
  • a manipulation device for translationally and rotationally moving the guide wire in the first channel relative to the catheter.
  • the catheter can be moved independently of the endoscope, and in particular can advance along the guide wire as soon as it has found the desired path.
  • the endoscope is designed as a flexible fiber optic or equipped with a camera chip.
  • the term endoscope in particular includes both embodiments below.
  • a particular field of application of the invention is the use in a bronchus blocker which has an inflatable balloon in the region of its lower end, in particular in the form of a concentric surrounding the catheter, the positioning system for positioning the lower end of the catheter in the respiratory tract of a Patients, especially in the field of bronchi, is designed.
  • the balloon While the catheter is inserted and has not yet reached its final position, the balloon is not or at least not fully inflated and thus requires only little more space than the catheter itself. Once the desired position of the bronchial blocker has been reached, the balloon can be inflated , which then typically a certain part of the lung is shut off and can be ventilated, for example, through the first channel of the catheter or even completely or partially evacuated.
  • the guide wire is torsionally rigid and its first portion is at least partially flexible and pre-bent, preferably with a pre-bent tip region in the form of approximately a quarter circle, also referred to in the art as "half J" (depending on the application can also have a longer again just executed tip).
  • the pre-bent tip region is designed in the form of an "S".
  • This special shape has the advantage that as the guide wire is pushed further out of the channel, the radius on which the tip of the guide wire moves increases.
  • the pre-bent tip portion Upon complete retraction of the guidewire into the lower end of the catheter, the pre-bent tip portion is bent almost straight, but must be resilient enough to resume its pre-bent shape when pushed out of the lower end.
  • the tip of the guide portion can be placed in any desired direction, even against gravity, allowing the catheter to follow the guide wire in any desired direction, and thus in branches Any desired branch of the bronchi can be pushed and positioned there.
  • This precise guidance of the guide wire can be carried out most easily by means of a manipulation device, this manipulation device comprising a piston guided in a hollow cylinder with a preferably rotatably supported piston in the piston, the piston guide rod, which preferably terminates in a manipulation end, wherein the piston in slidably mounted on the hollow cylinder and the guide wire in both, ie in the piston and / or in the hollow cylinder, each with sufficient friction that a set by manipulation of the manipulation device position is maintained until a next manipulation and wherein the guide wire to the piston guide rod for Transmission of translational and rotary movements is connectable, preferably by means of a locking device.
  • the manipulation device is suitable for so-called “one-hand operation.”
  • Hand Operation “allows the catheter to be used with one single person, along with the guided endoscope, allowing the guidewire, catheter and endoscope to move simultaneously for fast and precise guidance of the guidewire B.
  • Bronchial blockers can be positioned within a very short time.
  • a catheter according to the invention may have more than one channel, also called lumen.
  • the invention is applicable to various known catheters, in particular to bronchus blockers, in which there is at least one second channel, separate from the first channel, which serves in particular for inflating and venting a balloon.
  • the catheter is dimensioned and designed so that it can be inserted next to an endoscope through a breathing tube, in particular also of a pediatric size, into a trachea of a patient.
  • a catheter can be performed with a balloon at its lower end with an endoscope through a breathing tube so that the balloon is always in front of the tip of the endoscope, so that they do not have to fit through the breathing tube simultaneously with the thickened portion of the catheter to which the balloon is attached.
  • the catheter After removal of the guidewire and manipulation device, the catheter may continue to be used in a conventional manner. It is particularly advantageous if the guide wire is protected by a protective cover and thus kept hygienically clean.
  • a protective cover can be provided, which remains pushed together with mounted manipulation device on this and can be pushed back on pulling the wire over this, that the wire is completely enveloped by the protective cover.
  • the catheter of the invention is provided with suitable ports for connecting the manipulation device to the catheter and / or connecting all the channels of the catheter to other devices.
  • the guide wire has at least one marking at least in the first subregion. It is particularly proposed that these represent at least one marker (or more markers) units of length, z. In millimeters, inches or similar.
  • a plurality of markings should form a scale, preferably starting from the tip of the guide wire along the first subregion (and in particular along a curved central axis following the bending of the pre-formed tip region).
  • the scale may be attached to the pre-bent tip region such that the length units are of a (imaginary) rectilinear first region. Guide wire, ie, from a straight center axis, are projected onto the pre-bent tip portion.
  • At least the tip of the guide wire or at least the pre-bent tip region or at least the first subregion has at least one color coding.
  • different colors can be used, so that z. B. the markers on the guidewire or certain portions of the guidewire are designed differently colored.
  • the at least one color coding or the at least one marking be reflective or fluorescent.
  • At least partial regions of the guide wire have a coating or are formed by a coating of the guide wire.
  • the coating differs in color from the guide wire.
  • the coating preferably has reflective or fluorescent properties.
  • a particularly advantageous embodiment of the guide wire comprises that at least partial regions of the guide wire (the tip, the pre-bent tip region, the first partial region, the region with markings) are formed by a metal-free and flexible (atraumatic) plastic material.
  • these subregions are each executed exclusively (ie not as a coating) of this plastic material (where further Be laminations are possible on this plastic material, eg as markings and / or color markings).
  • the markings and / or the color identifications are designed so that they can be detected or read by means of a tracked endoscope.
  • the markings and / or the color identifications are preferably designed so that they are better visible when illuminated by a light source in the endoscope or on the catheter (eg, markings and / or color identifications are reflective or fluorescent).
  • a light source is arranged in the usual way in the endoscope and / or at the lower end of the catheter.
  • the catheter may have LEDs or similar small-sized light sources at the lower end of the catheter.
  • light is transported through the catheter by means of light-conducting fibers toward the lower end of the catheter, so that light sources and light exit towards the guide wire can also be arranged at a distance from one another.
  • At least the lower end of the catheter may (like the guide wire) be reflective or fluorescent, so that an additional light source is not required.
  • the illumination or marking / color coding of the guide wire in particular facilitates the positioning of the tip of the guide wire.
  • the markers / color identifiers Drawings but suitable to determine the dimensions of tumors, injuries and openings or distances.
  • the guide wire has a low-friction surface, for.
  • a suitable guidewire material for example, a hydrophilic material / a hydrophilic coating is proposed.
  • the low friction surface minimizes friction between both the guidewire and the inner wall of the canal in the catheter as well as the surrounding tissue.
  • a method for positioning a catheter according to the invention in a cavity system of a human / animal body is also provided.
  • the catheter has an upper end and a lower end and at least one first channel connecting both ends, into which a guide wire which is translationally, ie axially and rotationally movable, is inserted, which is at least so long that a first at least partially flexible and pre-bent part region of the Guidewire at the lower end of the first channel is pushed out, while a second portion at least partially always protrudes from the upper end of the catheter, and wherein a manipulation device with the upper end of the catheter and the guide wire is connected so that the guide wire by means of Manipulation device is translationally and rotationally displaceable in the first channel and wherein the guide wire is guided by the manipulation device in the cavity system to a desired position and then the catheter is pushed together with the guide wire or via this to a desired position.
  • the guide wire and the catheter are guided to a desired position by means of a tracked endoscope and by visual
  • This method is preferably used for positioning a bronchus blocker with an inflatable balloon in the region of its lower end, wherein the cavity system is formed by the trachea and the bronchi of a human lung and the positioning is carried out under observation by an endoscope, in particular a bronchoscope.
  • an endoscope in particular a bronchoscope.
  • the method is by no means limited to such applications. In particular, it is suitable for all organs or body parts of humans and animals containing gases or transparent liquids (eg also digestive tract, urinary tract, etc.).
  • a bronchial obturator which can be controlled by means of a manipulation device and a (axially) rigid guide wire with (preferably) pre-bent, flexible (semi-rigid) tip.
  • the guidewire lies in the lumen of the bronchus Blockers and can be advanced and retracted by the attached manipulation device and rotated (independent of the axial movement).
  • the displacement of the manipulation device is dimensioned so that the maximally advanced guidewire on the one hand optimally leads the bronchial block or holds in position, but on the other hand when advancing or after positioning of the bronchus blocker not so far in the lung periphery that the guide wire can perforate the lungs ,
  • the preferred shape of the tip portion of the guidewire corresponds to a half "J" (with a radius of "J” of about 2 cm).
  • other tip geometries are imaginable (eg straight or slightly bent, half "J” with an optionally longer straight-drawn tip, full “J", different radii of the "J”).
  • a prototype of the manipulation device was realized on the basis of a 1 ml syringe.
  • the function of this prototype in combination with a pediatric Arndt Endobronchial Blocker, from which the nylon thread was pulled out, will be explained.
  • This combination creates a new bronchus blocker system because the Arndt Endobronchial Blocker without nylon thread or loop is equivalent to a single-channel catheter with an inflatable balloon at the tip.
  • the construction of the 1 ml syringe (hollow cylinder and piston with rotatable sealing plug), the axial advancement or retraction of the guide wire by advancing or retracting the piston and the rotation of the guide wire and thus orientation of its tip separated by rotation of the piston in the hollow cylinder.
  • the torsion-resistant guidewire is passed through the rotatable sealing plug and firmly braided through holes in the piston.
  • the prototype manipulation device inserted in the Luer-Lock connector of the Arndt Endobronchial Blocker allows a displacement of the guidewire of approx. 5 cm.
  • the bronchial obturator is prepared with the tamper-evident guidewire with manipulation device that appears appropriate for the intended procedure. It is advisable to rinse the channel of the bronchus blocker with sterile water or sterile "physiological" saline before inserting the guidewire much easier and then sliding on a fluid film with virtually no friction, resulting in precise manipulation with the guide wire allows.
  • the bronchial blocker is first placed in the trachea with the manipulation device (but not yet inserted) in place and the guidewire is fully inserted in the channel of the blocker. For the sake of simplicity, this happens before the intubation, ie the bronchus blocker is then located after the intubation next to the (or coaxial with) the conventional breathing tube.
  • the bristle of the bronchus blocker is pressed against the tracheal wall by the inflated cuff of the breathing tube and fixed - albeit still displaceable.
  • the endoscope is then replaced by a conventional bronchoscopic adapter attached to the tube (contra-angle with a sealable membrane opening on which the respiratory system is attached). tem) is introduced. Special multi-port adapters (with a dead volume that is not unproblematic in pediatric surgery) are therefore unnecessary for ventilation during the endoscopically / fiber-optically controlled positioning of the bronchial blocker.
  • the guide wire is now pushed out of the bronchial obturator by advancing the plunger of the manipulation device and the (preferably) prebent, flexible (semi-rigid) tip so orientates it to travel into the desired (main) bronchus as the guidewire and / or bronchus blocker advances further. If the bronchus blocker is advanced further, it will inevitably follow the guide wire in the desired direction.
  • the tip By appropriately advancing or retracting the (preferably) pre-bent, flexible (semi-rigid) tip of the guidewire into the lumen of the bronchial obturator, the tip can also be partially deburred so that it can reach almost any point in the space in front of the bronchial block. As a result, the targeted probing and positioning of the bronchus blocker at the desired location in the bronchial system is ultimately possible.
  • Positioning of the bronchial obturator against gravity is also possible with a suitably shaped tip of the guide wire.
  • the entire positioning procedure can easily be controlled endoscopically / fiber optically. Difficult manipulations on or with the endoscope are unnecessary; the endoscope is merely a camera that only needs to be kept still, but not a tool or positioning device (as in the above-described Arndt system), so this new bronchus blocking system is easier and faster to use.
  • the space required for the positioning of the bronchus blocker is inherently minimal. This procedure is limited only by the bronchus (inner) diameter, which must be large enough to possibly insert an endoscope next to the guide wire or to be able to advance and position the bronchus obstruction after placement of the guide wire and retraction of the endoscope. Thus, in principle, therefore, positions of the bronchus blocker far into the lung periphery are possible. At the same time one always keeps an overview; The view of lower-lying structures in the bronchial system is lost only by advancing the blocker into the desired position and inflating the cuff.
  • the (cylindrical, spherical or even aspherical) cuff is made of a very thin membrane (eg polyurethane) and dimensioned so that the cuff already tightly seals the bronchus to be blocked before the cuff is maximally inflated.
  • a very thin membrane eg polyurethane
  • the guidewire After placement of the bronchus blocker, the guidewire is typically completely removed to remove the lumen of the bronchial tube. Blockers for draining or sucking gas from the blocked lung release.
  • a desirable embodiment of the invention is attached to the manipulation device, thin plastic sheath, which pushed together during advancement of the guide wire while z. B. is pushed onto the manipulation device. Upon retraction of the guidewire, this sheath is pulled apart again, then envelops the guidewire and keeps it sterile. If the bronchial blocker has to be repositioned, the guidewire can be pushed forward quickly and hygienically (even without sterile gloves).
  • the guidewire can of course also remain in the bronchial blocker or, if there is sufficient lung collapse, be pushed back into it, in order to stabilize the blocker even better and thus to hold it in position better.
  • the bronchus blocker which is already fixed by the inflated cuff of the breathing tube something, if necessary, even with an adhesive strip or Velcro (or similar fasteners) are secured to the tube.
  • the manipulation device described is also useful in combination with any other guidewire or catheter (with or without balloon), as well as the probing or catheterization of other cavities vacate in the human body z.
  • B. for vascular imaging or for interventional procedures under fluoroscopy (X-rays) can be simplified.
  • the use of the manipulation device described in a long-term probing requires only a modification in which the guide wire is then passed through the rotatable sealing plug, along the piston and through a hole in the rear piston plate.
  • a small clamping device (unless the friction in the sealing plug is sufficient) makes it possible to secure the guidewire on the piston, if necessary, so that it can not be displaced.
  • FIG. 1 shows a schematic view in longitudinal section of a catheter according to the invention during the process of positioning
  • Fig. 2 a cross section along the line II-II through Fig. 1; 3 shows a prototype of the device according to the invention with the first section withdrawn;
  • FIG. 4 shows a prototype of a catheter according to the invention with the first section of the guidewire extended.
  • Fig. 5 a lower end of the catheter and the largely withdrawn guidewire
  • Fig. 6 a lower end of the catheter and the advanced guide wire
  • FIG 8 shows the guide wire with pre-bent tip region according to a second embodiment variant.
  • Fig. 1 shows schematically a cavity system 1 in the human body, in the present case a portion of the bronchi in the lungs of a human.
  • An inventive catheter 2 is shown during the process of positioning in this cavity system 1.
  • the catheter 2 has an upper end 3 and a lower end 4, wherein a first channel 5 connects these two ends together.
  • a guide wire 6 which is so long that a first portion 7 protrudes from the lower end 4, while a second portion 8 protrudes from the upper end 3 of the catheter 2.
  • the first portion 7 has a pre-bent tip portion 9, which is approximately the shape of a quarter circle Has.
  • the catheter 2 has a connection 10, on which a manipulation device 11 can be attached.
  • this consists of a hollow cylinder 12, in which a piston 13 is guided on a piston guide rod 14.
  • the guide wire 6 extends in the manipulation device 11 in a passage 15 and enters a passage 16 in the piston 13 and the piston guide s rod 14 a.
  • the piston guide s rod 14 passes into a tamper end 17, which is shaped for handling by the human hand, as is known for example from medical syringes.
  • a locking device 18 serves to connect the guide wire 6 in any initial position with the piston guide s rod 14 so that the guide wire 6 with the piston guide s rod 14 and the piston 13 translationally, ie axially, can be moved and at the same time the piston guide s rod 14 is rotatably movable, so in the first channel 5 can be rotated.
  • an inflatable balloon 19 is arranged, which preferably has the shape of a catheter 2 enclosing the full-thickness.
  • This balloon (cuff) can be replaced by a second 20 inflated so that it closes the surrounding vessel, in the present case a bronchus, and thus separates the underlying part of the lung from the rest of the lungs.
  • a suitable inflator 21 serves to inflate at an appropriate pressure and to maintain this pressure for a desired period of time.
  • a flexible fiber optic in the present case a bronchoscope 22, wherein the catheter 2 and the endoscope (eg flexible fiber optic) 22 should be designed to simultaneously pass through a breathing tube 24 can be passed in the trachea of a patient, although, as described above, it is also possible to move the catheter 2 adjacent to a breathing tube 24.
  • Fig. 2 shows a cross-section through Fig. 1 along the line II-II, that is, a cross section through the breathing tube 24 with inserted bronchoscope 22 and parallel catheter 2.
  • Fig. 2 illustrates without being true to scale the conditions in the trachea a patient.
  • the bronchoscope 22 and the catheter 2 according to the invention should be designed and dimensioned such that they both fit into the respiratory tube 24, preferably even in confined spaces, such as may occur in very young children. It can be seen that the second channel 20 for inflating the balloon 19 generally requires only little space in the cross section of the catheter, possibly also on its outside, and that the guide wire 6 does not necessarily have to fill a large part of the first channel 5, then that there are also situations in which the first channel 5 can fulfill its actual function while the guidewire 6 remains therein.
  • FIG 3 shows a photograph of a prototype of the catheter 2 according to the invention with the first part region 7 of the guide wire 6 withdrawn.
  • Fig. 4 shows the same prototype but with advanced first portion 7 of the guidewire 6 and during rotational manipulation by rotation at the manipulating end 17 of the piston guide rod 14.
  • Fig. 5 shows a lower end of the catheter 4 and the largely withdrawn guidewire 6.
  • the guidewire 6 faces in the pre-bent tip portion 9 an S-shape.
  • the largely withdrawn guide wire 6 is supported laterally on the inner wall of the lower end of the catheter 4, so that the tip 28 of the guide wire 6 can be arranged around the central axis 31 only within a small radius 32 due to a rotational movement.
  • 6 shows a lower end of the catheter 4 and the now extended guidewire 6 of FIG. 5.
  • the pre-bent tip region 9 is now located outside the lower end of the catheter 4, the tip 28 of the guidewire 6 due to a rotational movement within a Nes larger radius 32 can be arranged around the central axis 31.
  • the lower end of the catheter 4 can be used as a light source 35.
  • photoconductive fibers may extend along the catheter 2, wherein the light source 35 z. B. in the second portion 8 of the catheter 2 is arranged.
  • LEDs can also be arranged at the lower end of the catheter 4 or the lower end of the catheter 4 can be made fluorescent.
  • FIG. 7 shows the guidewire 6 with pre-bent tip region 9 according to a first embodiment in an enlarged view.
  • the guide wire 6 has towards the second portion 8 a largely rectilinear region 33.
  • the guide wire 6 has a scale 23 with length units 27, which are identified by markings 26.
  • the scale 23 extends from the tip 28 of the guide wire 6 along the curved central axis 34.
  • the curved central axis 34 follows the course of the guide wire 6.
  • a mark 26 in the form of a color coding 29 is arranged , This is designed here as a coating 30 of the guide wire 6.
  • FIG. 8 shows the guidewire 6 with pre-bent tip region 9 according to a second embodiment s variant in an enlarged representation.
  • Fig. 7 is a scale 23 is arranged on the guide wire 6, which was projected from the (rectilinear) central axis 31 on the pre-bent tip portion 9 of the guide wire 6. This projection makes it possible to measure the distance or size even at the pre-bent tip region 9, which in the extended state is largely undeformed.
  • the present invention enables rapid and precise positioning of a catheter at locations where this is slow or difficult with conventional means. Positioning against gravity, in particular, is possible even without transferring a patient.

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  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Emergency Medicine (AREA)
  • Otolaryngology (AREA)
  • Biophysics (AREA)
  • Endoscopes (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un cathéter (2) comprenant une extrémité supérieure (3) et une extrémité inférieure (4), et muni d'au moins un premier conduit (5) reliant les deux extrémités ainsi que d'un système de positionnement servant à positionner l'extrémité inférieure (4) dans un système creux (1) du corps humain. Le système de positionnement comprend un fil de guidage (6) qui peut effectuer un mouvement de rotation ou de translation dans le premier conduit (5) dans lequel il peut être introduit ou dont il peut être retiré, et qui est au moins suffisamment long pour qu'une première partie (7) du fil de guidage (6) puisse être extraite du premier canal (5) au niveau de l'extrémité inférieure (4), tandis qu'une deuxième partie (8) continue de dépasser au moins en partie du cathéter (2) au niveau de l'extrémité supérieure (3). L'invention concerne également un dispositif de manipulation (11) permettant d'imprimer au fil de guidage (6) un mouvement de translation ou de rotation par rapport au cathéter (2) dans le premier canal (5).
PCT/EP2014/051625 2013-01-31 2014-01-28 Cathéter muni d'un système de positionnement Ceased WO2014118172A1 (fr)

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Application Number Priority Date Filing Date Title
DE102013100991.3 2013-01-31
DE201310100991 DE102013100991A1 (de) 2013-01-31 2013-01-31 Katheter mit Positioniersystem

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WO2014118172A1 true WO2014118172A1 (fr) 2014-08-07

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Cited By (2)

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WO2016207583A1 (fr) * 2015-06-24 2016-12-29 Smiths Medical International Limited Ensembles de dispositifs d'introduction de tube et procédés associés
EP3538193A4 (fr) * 2016-11-10 2020-07-29 Eva Innovations Dispositif d'insertion pour insertion par une seule main d'un fil-guide dans la lumière d'un vaisseau/cavité

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US11285286B1 (en) 2020-09-08 2022-03-29 Lukasz R. Kiljanek Ventilator system with multiple airflow control lumens

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EP0803263A2 (fr) * 1996-04-25 1997-10-29 Smiths Industries Public Limited Company Dispositif d'introduction et ses éléments
EP1062971A1 (fr) * 1999-06-25 2000-12-27 BIOTRONIK Mess- und Therapiegeräte GmbH & Co Ingenieurbüro Berlin Cathéter muni d'un port distal pour un fil
WO2002070038A2 (fr) * 2001-03-05 2002-09-12 O'mara Sean T Dispositif et procede d'intubation
US20060157060A1 (en) * 2004-06-05 2006-07-20 Nelson Lindsey A Intubation device
US7650886B1 (en) * 2004-03-04 2010-01-26 Christian Keller Esophageal airway management device guides
WO2013008087A1 (fr) * 2011-07-14 2013-01-17 Med Works Limited Fil de guidage doté d'une poignée

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US5904648A (en) * 1996-06-18 1999-05-18 Cook Incorporated Guided endobronchial blocker catheter

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EP0803263A2 (fr) * 1996-04-25 1997-10-29 Smiths Industries Public Limited Company Dispositif d'introduction et ses éléments
EP1062971A1 (fr) * 1999-06-25 2000-12-27 BIOTRONIK Mess- und Therapiegeräte GmbH & Co Ingenieurbüro Berlin Cathéter muni d'un port distal pour un fil
WO2002070038A2 (fr) * 2001-03-05 2002-09-12 O'mara Sean T Dispositif et procede d'intubation
US7650886B1 (en) * 2004-03-04 2010-01-26 Christian Keller Esophageal airway management device guides
US20060157060A1 (en) * 2004-06-05 2006-07-20 Nelson Lindsey A Intubation device
WO2013008087A1 (fr) * 2011-07-14 2013-01-17 Med Works Limited Fil de guidage doté d'une poignée

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SEBRANEK JJ ET AL., PLACEMENT OF AN ARNDT ENDOBRONCHIAL BLOCKER USING A SELDINGER TECHNIQUE IN A PATIENT WITH LEFT MAINSTEM BRONCHIAL COMPRESSION (ABSTRACT), SOCIETY FOR AIRWAY MANAGEMENT 16TH SCIENTIFIC MEETING. TORONTO, 21.-23.9.2012

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016207583A1 (fr) * 2015-06-24 2016-12-29 Smiths Medical International Limited Ensembles de dispositifs d'introduction de tube et procédés associés
US11020555B2 (en) 2015-06-24 2021-06-01 Smiths Medical International Limited Tube introducers, assemblies and methods
EP3538193A4 (fr) * 2016-11-10 2020-07-29 Eva Innovations Dispositif d'insertion pour insertion par une seule main d'un fil-guide dans la lumière d'un vaisseau/cavité
US11260206B2 (en) 2016-11-10 2022-03-01 EVA Innovations, Inc. Insertion device for one-handed insertion of a guidewire into the lumen of a vessel/cavity
EP4137192A1 (fr) * 2016-11-10 2023-02-22 Eva Innovations Dispositif d'insertion pour l'insertion d'un fil guide dans la lumière d'un vaisseau/cavité
US11819643B2 (en) 2016-11-10 2023-11-21 EVA Innovations, Inc. Insertion device for one-handed insertion of a guidewire into the lumen of a vessel/cavity

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