DE3737121A1 - Controllable sealing system for catheter and instrument insertion kits - Google Patents

Controllable sealing system for catheter and instrument insertion kits

Info

Publication number
DE3737121A1
DE3737121A1 DE19873737121 DE3737121A DE3737121A1 DE 3737121 A1 DE3737121 A1 DE 3737121A1 DE 19873737121 DE19873737121 DE 19873737121 DE 3737121 A DE3737121 A DE 3737121A DE 3737121 A1 DE3737121 A1 DE 3737121A1
Authority
DE
Germany
Prior art keywords
seal
sealing
sealing sleeve
hollow organ
seals
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.)
Granted
Application number
DE19873737121
Other languages
German (de)
Other versions
DE3737121C2 (en
Inventor
Alexander Staeblein
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.)
STAEBLEIN, ALEXANDER, DR.MED., 50677 KOELN, DE
Original Assignee
Alexander Staeblein
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 Alexander Staeblein filed Critical Alexander Staeblein
Priority to DE19873737121 priority Critical patent/DE3737121A1/en
Publication of DE3737121A1 publication Critical patent/DE3737121A1/en
Application granted granted Critical
Publication of DE3737121C2 publication Critical patent/DE3737121C2/de
Granted legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3462—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals
    • 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
    • A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00902—Material properties transparent or translucent
    • A61B2017/00907—Material properties transparent or translucent for light
    • 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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
    • A61M2025/0079—Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
    • 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
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M39/0613—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof with means for adjusting the seal opening or pressure

Abstract

Medical interventions in hollow organs have to date frequently been carried out with thin-walled plastic tubes inserted in the hollow organ. If there is a pressure difference between the outside and the hollow organ, problems arise that have previously been solved by using elastic abradant seals which damaged sensitive instruments or tissue parts to be removed, however. In the present case, the seal used is an annular sealing cuff of an elastic or at least flexible material which seals, narrows or exposes the cross-section to be sealed on filling of the cuff interior with gaseous or liquid media. A pneumatically or hydraulically controllable sealing cuff permits partial or complete closure of the cross-section of the connection between the hollow organ and the outside as required, or complete exposure of it, and this permits unproblematical insertion even of sensitive instruments especially in conjunction with a conventional sealing system in the form of the specified system.

Description

Bei Eingriffen operativer- oder nichtoperativer Art in Hohlorgane oder Systeme von Hohlorganen (z. B. das Blutgefäßsystem) stellt sich häufig das Problem, Katheter oder andere Instrumente durch eine mittels Schnitt oder Stich geschaffene Öffnung einzuführen. Dies bietet keine Schwierigkeiten, solange der Durchmesser des einzuführenden Instrumentes klein und über die Länge gleichmäßig groß ist, und zwischen dem Inneren des punktierten Organs und der Umgebung kein zu großer Druckunterschied herrscht. Allerdings wirkt es erschwerend, wenn das eingeführte Instrument häufig aus dem Hohlorgan entfernt und wieder eingeführt werden soll, was z. B. bei Wechsel der Instrumentengröße oder bei einer Entfernung von Material aus dem Hohlorgan notwendig wird.In the event of surgical or non-surgical interventions in Hollow organs or systems of hollow organs (e.g. the Blood vessel system) often presents the problem, catheter or other instruments by means of a cut or Introduce stitch created opening. This does not offer Difficulties as long as the diameter of the inserted Instrument is small and uniform over the length, and between the inside of the dotted organ and the There is not too great a pressure difference in the environment. However, it is aggravating if the introduced Instrument often removed from the hollow organ and again should be introduced what z. B. when changing Instrument size or when removing material the hollow organ becomes necessary.

Um diese Maßnahmen zu erleichtern werden bisher routinemäßig sogenannte Einführbestecke oder "Schleusen" verwendet, die vorwiegend aus einem Stück sehr dünnwandigen Kunststoff- Schlauches bestehen, der über einen Stich in das gewünschte Hohlorgan eingelegt wird und somit eine Verbindung des Innenraumes mit der Außenwelt schafft, durch die problemlos Katheter und die notwendigen Instrumente eingeführt werden können. Besteht zwischen dem Innenraum des Hohlorganes und dem äußeren Umfeld ein nennenswerter Druckunterschied, der aufrechterhalten werden soll, so ist am äußeren Ende des Schlauches eine Einrichtung angebracht, die über eine gelochte oder geschlitzte Gummischeibe oder ein profiliertes Elastomer-Teil, das von dem hindurchgeführten Instrument verformt und aufgedehnt wird und sich eng an das eigeführte Gerät anlegt (Abb. 2/7), eine Abdichtung herbeiführt.In order to facilitate these measures, so-called introducer or "locks" have been routinely used, which mainly consist of a piece of very thin-walled plastic tubing, which is inserted into the desired hollow organ via a stitch and thus creates a connection between the interior and the outside world which can be easily inserted catheters and the necessary instruments. If there is a significant pressure difference between the interior of the hollow organ and the external environment that is to be maintained, a device is attached to the outer end of the hose, which has a perforated or slotted rubber washer or a profiled elastomer part that deforms from the instrument passed through it and is stretched and lies close to the inserted device ( Fig. 2/7), creates a seal.

Die Nachteile einer solchen Abdichtung sind folgende:The disadvantages of such a seal are as follows:

  • 1. Bei Verwendung von Kathetern oder Instrumenten mit sehr großem Durchmesser (z. B. Ballonkathetern für die Auf­ weitung von Aortenklappen) ist eine zuverlässige Abdichtung über den gesamten Durchmesserbereich (0 mm bis ca. 6 mm Durchmesser) oft nicht zu erreichen.1. When using catheters or instruments with very large diameter (e.g. balloon catheters for opening dilation of aortic valves) is a reliable one Sealing over the entire diameter range (0 mm up to approx. 6 mm diameter) often cannot be reached.
  • 2. Müssen empfindliche Instrumente oder Katheter durch die Abdichtung in den Schlauch eingeführt werden, so besteht die Gefahr, daß sie durch den mechanischen Widerstand, der zur Verformung der elastischen Abdichtung überwunden werden muß, beschädigt oder zerstört werden (z. B. Führungsdrähte an Atherektomie-Kathetern).2. Need sensitive instruments or catheters through the Seal to be inserted into the hose, so there is a risk that the mechanical Resistance to deformation of the elastic Sealing must be overcome, damaged or destroyed (e.g. guide wires on Atherectomy catheters).
  • 3. Sollen mit Hilfe von Kathetern Gewebe oder Fremdkörper aus dem Hohlorgan entfernt werden, so besteht die Gefahr, daß die an der Katheterspitze durch Unterdruck oder andere Haltemechanismen festgehaltenen Körper durch die elastische Dichtung abgestreift werden und so verloren gehen.3. Should use tissue or foreign objects with the help of catheters are removed from the hollow organ, so there is Danger of negative pressure on the tip of the catheter or other holding mechanisms be stripped by the elastic seal and so get lost.
  • 4. Bei Eingriffen in das Blutgefäßsystem lagert sich abhängig von der Zeit, die der Katheter innerhalb des Gefäßes verbleibt eine Schicht von Ablagerungen des Blutgerinnungssystems an den Katheterschaft an. Diese Ablagerungen werden bei Entfernung des Katheters durch die elastische Abdichtung abgestreift, teils festgehalten und bei erneutem Einführen von Geräten durch die Abdichtung in das Gefäßsystem verschleppt, wo sie Anlaß zu akuten Gefäßverschlüssen sein können.4. During interventions in the blood vessel system, the patient is lying down depending on the time the catheter is inside the There remains a layer of deposits of the vessel Blood coagulation system to the catheter shaft. These Deposits are removed when the catheter is removed  the elastic seal stripped, partly and when devices are reinserted carried through the seal into the vascular system where they can give rise to acute vascular occlusions.

Die obengenannten Nachteile der bisher verwendeten Systeme werden bei der vorgelegten Erfindung durch mehrere neue Maßnahmen vermieden:The above disadvantages of the systems used so far are in the presented invention by several new Measures avoided:

Alleine oder zusätzlich zu einer Abdichtung der Schleuse durch eine elastische, schleifende Abdichtung wird eine hydraulisch (oder pneumatisch) einstellbare Dichtmanschette eingeführt, die es gestattet, von außen durch Füllen oder Entleeren der Manschette mit Flüssigkeit (oder Gasen) sowohl den Durchlaß vollkommen abzudichten oder freizugeben, als auch jedem hindurchgeführten Instrument anzupassen. Dabei ist es durch Füllen der Manschette mit nicht zu hohem Druck auch möglich, sowohl eine Abdichtung, als auch eine leichte Verschiebbarkeit der hindurchgeführten Katheter oder Instrumente zu erreichen.Alone or in addition to sealing the lock an elastic, abrasive seal creates a hydraulically (or pneumatically) adjustable sealing sleeve introduced, which allows filling or filling from the outside Drain the cuff with both liquid (or gases) to completely seal the passage or to release it as also adapt to any instrument passed through it. Here it is by filling the cuff with not too high pressure also possible, both a waterproof and a light Slidability of the catheters passed through or Instruments.

Bei kombiniertem Einsatz sind die beiden Abdichtungssysteme voneinander räumlich getrennt angebracht und werden durch eine transparente Kammer verbunden (Abb. 2/4). Das von außen steuerbare Abdichtungssystem ist dabei an der dem Hohlorgan zugewendeten Seite der Kammer angebracht.When used in combination, the two sealing systems are installed separately from each other and are connected by a transparent chamber ( Fig. 2/4). The externally controllable sealing system is attached to the side of the chamber facing the hollow organ.

Die Verbindungskammer ist an jedem Ende mit verschließbaren Seitenanschlüssen versehen, die es ermöglichen, die Kammer zu spülen, um eine optimale Durchsicht zu gewähren und Fremdkörper durch Spülung aus der Kammer zu entfernen. The connection chamber is at each end with closable side connections provided it allow the chamber to be flushed for optimal To allow visibility and foreign bodies by flushing out the Remove chamber.  

Die transparente Kammer ist durch eine - ohne Werkzeug - schnell zu lösende Verbindung an dem steuerbaren Abdichtsystem befestigt (Abb. 2/3), so daß größere Fremdkörper problemlos aus der Kammer entfernt werden können und andere Katheter (eventuell mit anderen Kammern und Abdichtungen) eingesetzt werden können. Empfindliche Katheter können bei geschlossenem inneren Abdichtsystem in Ruhe und ohne Druckausgleich/Blutverlust - unter Verwendung eines dünnwandigen Rohres zum Offenhalten der Dichtmembran - durch das äußere Dichtsystem geführt werden. Daraufhin kann nach Entfernen des Rohres zum Einführen der Katheter ohne mechanische Belastung der Spitze durch die inzwischen geöffnete innere Abdichtung in das Hohlorgan vorgeschoben werden.The transparent chamber is attached to the controllable sealing system by a connection that can be quickly removed without tools ( Fig. 2/3), so that larger foreign bodies can be removed from the chamber without any problems and other catheters (possibly with other chambers and seals) are used can be. With the inner sealing system closed, sensitive catheters can be guided through the outer sealing system at rest and without pressure equalization / blood loss - using a thin-walled tube to keep the sealing membrane open. Thereupon, after removing the tube for inserting the catheter, the inner seal which has now been opened can be pushed into the hollow organ without mechanical stress on the tip.

Die Größe und Form der Kammer, sowie Art und Größe der zweiten (äußeren) Abdichtung läßt sich der geplanten Anwendung anpassen. Auch während des Vorgehens läßt sich die Kammer mit ihrer zweiten Abdichtung leicht gegen eine andere austauschen, ohne daß es bei blockierter innerer Abdichtung zu einem Blutverlust, Druckausgleich o. ä. kommt.The size and shape of the chamber, as well as the type and size of the second (outer) sealing can be the planned Customize the application. Even during the procedure, the Chamber with its second seal slightly against another replace without it if the inner seal is blocked blood loss, pressure equalization or similar occurs.

Durch die Konstruktion der inneren Abdichtung ist gewähr­ leistet, daß Gewebe oder Materialien, die mittels eines Katheters o. ä, aus dem Hohlorgan entfernt werden sollen nicht durch die Abdichtung von dem Katheter o. ä. abgestreift werden und somit verlorengehen. Dies wird dadurch erreicht, daß der Innenraum der dehnbaren Manschette mit Unterdruck beaufschlagt wird, sich die Manschette dem Druckgefälle folgend eng an die Innenwandung des Schleusenkörpers anlegt und somit den vollen Querschnitt freigibt (Abb. 1a). The construction of the inner seal ensures that tissues or materials which are to be removed from the hollow organ by means of a catheter or the like are not stripped off by the seal from the catheter or the like and are therefore lost. This is achieved by applying a vacuum to the interior of the stretchable sleeve, pressing the sleeve tightly against the inner wall of the lock body in accordance with the pressure drop, thus releasing the full cross-section ( Fig. 1a).

Querschnitt, Länge und Form der Dichtmanschette können den Anforderungen entsprechend gewählt werden. Je nach abzudichtendem Querschnitt sind dafür eine oder mehrere Kammern, die gleichzeitig oder getrennt voneinander gefüllt werden vorzusehen. Die Dichtmanschette ist aus einem dehnbaren, weichen und flexiblen aber dennoch reißfesten Material gefertigt (Natur- oder Synthesekautschuk oder Weichkunststoff, eventuell textilverstärkt).Cross section, length and shape of the sealing sleeve can be chosen according to the requirements. Depending on the cross-section to be sealed is one or more Chambers filled simultaneously or separately will be provided. The sealing sleeve is made of one stretchy, soft and flexible but still tearproof Material manufactured (natural or synthetic rubber or Soft plastic, possibly textile reinforced).

Claims (8)

1. Abdichtsystem, z. B. zur Abdichtung von Einführbestecken und "Schleusen", das eine von außen steuerbare - hydraulisch oder pneumatisch betätigte - variable Abdichtung ermöglicht, gekennzeichnet dadurch, daß eine Dichtmanschette verwendet wird, durch deren Beaufschlagung mit Unterdruck der abzudichtende Querschnitt freigegeben wird (Abb. 1a), um z. B. empfindliche Instrumente einzuführen oder Proben aus dem betroffenen Hohlorgan zu entnehmen. Wird die Manschette unter Überdruck gesetzt, so verschließt sie den freibleibenden Querschnitt entweder vollständig (Abb. 1b) oder legt sich an hindurchgeführte Instrumente eng an und führt eine Abdichtung herbei (Abb. 1c).1. sealing system, e.g. B. for sealing introducers and "locks", which enables an externally controllable - hydraulically or pneumatically operated - variable seal, characterized in that a sealing sleeve is used, by the action of which the negative pressure is released, the cross-section to be sealed is released ( Fig. 1a) to z. B. introduce sensitive instruments or take samples from the affected hollow organ. If the cuff is pressurized, it either closes the remaining cross-section completely ( Fig. 1b) or fits tightly on instruments passed through it and creates a seal ( Fig. 1c). 2. Dichtmanschette nach Anspruch 1, gekennzeichnet dadurch, daß sie aus Natur- oder Synthese-Kautschuk oder einem Weichkunststoff, eventuell gewebeverstärkt gefertigt ist.2. Sealing sleeve according to claim 1, characterized in that that they are made of natural or synthetic rubber or a Soft plastic, possibly fabric reinforced. 3. Dichtmanschette nach Anspruch 1 und 2, dadurch gekennzeichnet, daß sie eine Kammer besitzt (Abb. 1a- 1c).3. Sealing sleeve according to claim 1 and 2, characterized in that it has a chamber ( Fig. 1a- 1c). 4. Dichtmanschette nach Anspruch 1 und 2, dadurch gekennzeichnet, daß sie mehrere Kammern besitzt (z. B. Abb. 1d). 4. Sealing sleeve according to claim 1 and 2, characterized in that it has several chambers (z. B. Fig. 1d). 5. Dichtmanschette nach Anspruch 1 und 2 und einem der Ansprüche 3 bis 4, dadurch gekennzeichnet, daß sie als einzige Abdichtung an dem Ende eines Einführbesteckes oder ähnlichen Instrumentes angebracht ist.5. Sealing sleeve according to claim 1 and 2 and one of the Claims 3 to 4, characterized in that they as only seal at the end of an introducer or similar instrument is attached. 6. Dichtmanschette nach Anspruch 1 und 2 und einem der Ansprüche 3 bis 4, dadurch gekennzeichnet, daß sie in Verbindung mit einer zweiten Abdichtung (gelochte oder geschlitzte Membran oder zweite Dichtmanschette) a dem Ende eines Einführbesteckes oder ähnlichen Instrumentes angebracht ist (z. B. Abb. 2).6. Sealing sleeve according to claim 1 and 2 and one of claims 3 to 4, characterized in that it is attached in connection with a second seal (perforated or slotted membrane or second sealing sleeve) a the end of an introducer or similar instrument (z. B. Fig. 2). 7. Abdicht-System nach Anspruch 6, dadurch gekennzeichnet, daß die Verbindung zwischen beiden Abdichtungen durch eine durchsichtige Kammer hergestellt wird (Abb. 2/4), die an beiden Enden Seitenanschlüsse (Abb. 2/5 und 2/6) besitzt, die ein Spülen des Innenraumes mit durchsichtigen Flüssigkeiten und das Herausspülen von Verunreinigungen, Blut, Thromben etc. ermöglichen.7. Sealing system according to claim 6, characterized in that the connection between the two seals is made by a transparent chamber ( Fig. 2/4), which has side connections at both ends ( Fig. 2/5 and 2/6), which allow the interior to be rinsed with transparent liquids and contaminants, blood, thrombi etc. to be rinsed out. 8. Abdicht-System nach Anspruch 6 oder Anspruch 7, dadurch gekennzeichnet, daß zumindest eine - ohne Werkzeug - leicht trennbare, dichte Verbindung zwischen der Verbindungskammer und einer, oder beiden Abdichtungen besteht, die ein schnelles Abnehmen, Wechseln oder Reinigen der Verbindungskammer ermöglicht (Abb. 2/3), während sich das (mit der steuerbaren Abdichtung bockierte) Einführungsbesteck noch in dem zu untersuchenden/behandelnden Hohlorgan befindet.8. Sealing system according to claim 6 or claim 7, characterized in that there is at least one - without tools - easily separable, tight connection between the connecting chamber and one, or both seals, which enables quick removal, changing or cleaning of the connecting chamber ( Fig. 2/3), while the introducer (blocked with the controllable seal) is still in the hollow organ to be examined / treated.
DE19873737121 1987-11-02 1987-11-02 Controllable sealing system for catheter and instrument insertion kits Granted DE3737121A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
DE19873737121 DE3737121A1 (en) 1987-11-02 1987-11-02 Controllable sealing system for catheter and instrument insertion kits

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE19873737121 DE3737121A1 (en) 1987-11-02 1987-11-02 Controllable sealing system for catheter and instrument insertion kits

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DE3737121A1 true DE3737121A1 (en) 1989-05-11
DE3737121C2 DE3737121C2 (en) 1990-08-02

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