WO2012152689A1 - Gaine d 'introduction extensible et système de gaine - Google Patents

Gaine d 'introduction extensible et système de gaine Download PDF

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Publication number
WO2012152689A1
WO2012152689A1 PCT/EP2012/058237 EP2012058237W WO2012152689A1 WO 2012152689 A1 WO2012152689 A1 WO 2012152689A1 EP 2012058237 W EP2012058237 W EP 2012058237W WO 2012152689 A1 WO2012152689 A1 WO 2012152689A1
Authority
WO
WIPO (PCT)
Prior art keywords
channel
introducer sheath
instrument
introducer
lock
Prior art date
Application number
PCT/EP2012/058237
Other languages
German (de)
English (en)
Inventor
Vilmos Nagy
Original Assignee
Vilmos Nagy
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 Vilmos Nagy filed Critical Vilmos Nagy
Publication of WO2012152689A1 publication Critical patent/WO2012152689A1/fr

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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • 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
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M25/0668—Guide tubes splittable, tear apart
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M2025/0024—Expandable catheters or sheaths
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M2025/0035—Multi-lumen catheters with stationary elements characterized by a variable lumen cross-section by means of a resilient flexible septum or outer wall

Definitions

  • the present invention relates to an introducer sheath having at least one circumferentially closed first channel and a second channel in an initial state.
  • Introduction locks are used in the medical and veterinary field, where via an introducer sheath a percutaneous access, for example by puncture of a body cavity, or an endoscopic access to a natural body opening must be placed.
  • the introducer sheath have multiple channels, of which the first channel can serve as a working channel, for example for the insertion of catheters, optical instruments or the like, and the auxiliary channel for the delivery of, for example, liquids such as medicaments.
  • EP 0 593 181 B1 shows an inflexible introducer sheath with a main channel and a second channel separated therefrom, which is smaller in cross-section than the main channel.
  • the US 50 25 778 A shows an endoscope with an introducer tube with an introducer, within which several working channels are formed. Flexibility is changed by the inlet of liquids or the use of stiffening wires. Furthermore, both percutaneous and endoscopic access through natural orifices may require subsequent radial expansion of the accessory for the introduction of subsequent instruments. structure is required.
  • DE 602 20 792 T2 describes a dilatation tube which is radially expandable and which has an inner axial volume into which an expansion member can be pushed axially. This can be achieved by a folded or elastic tube. Alternatively, a layered or laminated structure having an outer elastic sheath and a separate slip-coated inner sheath may be provided. In this way, the expanded radius of the access channel can be maintained, which is formed by the insertion of a dilatation instrument.
  • the object of the present invention to provide an expandable multi-channel lock, which can release an instrument located in her outward.
  • This object is achieved by an introducer sheath having at least one circumferentially closed first channel and at least one second channel in an initial state, wherein the second channel is apparent by introducing an instrument in the first channel or in the second channel to the outside.
  • the introducer sheath can be referred to as a two-channel or multi-channel sheath.
  • An essential feature of the lock is that the first channel is radially or predominantly radially expandable and the second channel can open laterally. It can be provided that the second channel opens by the elongation of the first channel per se, by radially acting forces exerted by the first channel upon expansion to the second channel, or by an instrument inserted directly into the second channel.
  • An essential feature of the first channel is its ductility and the fact that it always remains a closed channel.
  • An essential feature of the second channel is that it is a closed channel in its initial state but loses itself after the opening. The advantage here is that in the second channel instruments can be placed to release them by opening the second channel to the outside. In the first channel, instruments that are to be worked through the lock can be introduced in the unexpanded state.
  • These instruments may include, for example, catheters, lasers; Be dilators or optical instruments.
  • these instruments can be designed such that they serve as an expansion member, so that they can bring the first channel to expand, so that the second channel according to the invention opens outward Shen.
  • the second channel can be opened directly by inserting the instrument into the second channel.
  • the second channel is used to hold instruments that are to be placed outside the lock.
  • Such an instrument is placed in the second channel either before the introducer sheath is pushed up and pushed up together with the introducer sheath, or the instrument is advanced into the second channel after the introducer sheath is pushed up. This results in a flexibility with respect to the working techniques to be used by the operator.
  • the introducer for example in the form of a wire and in English referred to as "guide" advanced in the second channel of the lock and then the lock with his him inserted insertion instrument turned It is also possible that the lock is introduced first and then the insertion instrument is advanced in the second channel In both cases, the instrument is released outwardly when the first channel is expanded or expanded by means of the expansion member or
  • such instrument may be a guiding instrument in the form of an insertion wire, which after opening the second channel, that is, when the first channel is in the expanded state by means of the expansion member has been brought, a u outside the lock lies.
  • the first channel can be expanded by inserting an instrument in such a way that the second channel is exposed to the outside.
  • the second channel may be apparent, with the first channel maintaining its initial state when the second channel is opened by the instrument.
  • the cross-sectional area of the first channel after opening the second channel takes at least the Cross-sectional area of the introducer sheath in the initial state.
  • a cross-sectional area of the second channel is smaller than a cross-sectional area of the first channel, in particular smaller than half the cross-sectional area of the first channel.
  • the cross-sectional area of the second channel is less than a quarter of the cross-sectional area of the first channel.
  • the second channel has a longitudinal separation point.
  • the separation point is defined at which point the second channel opens when the first channel is expanded by means of the expansion member.
  • the separation point it can be provided that it is formed by two mutually abutting or overlapping wall regions.
  • the wall regions abut one another it is advantageous that the introducer sheath, viewed in cross-section, has a continuous course at the separation point.
  • the advantage of overlapping wall areas is that this arrangement effectively prevents an instrument inserted in a bend through the second channel from inadvertently escaping outwardly through the separation point.
  • the separation point is a predetermined breaking point.
  • separation point with predetermined breaking point means that the opposing wall regions are materially connected, wherein in this area the material thickness can be reduced in order to ensure a defined cracking or separation under the action of force. This ensures in a particularly effective form that the instrument, which is pushed up by a bend through the second channel, not unintentionally from the second channel can step outside.
  • the second channel is hermetically sealed prior to initial expansion of the introducer sheath.
  • the introducer sheath has a memory effect, by which it resumes the initial state without further action by the instrument. This ensures that the introducer sheath in its initial state can be pulled out of the body opening or the vessel again, without injuring tissue.
  • the memory effect can be used to set various configurations at introducer sheaths. For example, after expansion by the instrument and after removal of the instrument, the first channel may remain stretched or not stretched accordingly. The same can also be provided for the second channel, namely that after the removal of the instrument from the first channel it either remains open or closes again.
  • the introducer sheath may have a bendable body inner end.
  • This body-internal end can be designed as a bendable tip of the introducer sheath.
  • This can be bendable from the inside of the body to an arbitrarily long distance to the body end ßeren ßeren.
  • a memory effect can be provided, for example, for the body and / or technicallyäu ßeren ends of the introducer, namely by the tip after it has been bent by a suitable application from the inside or from the outside Shen either this bend retains or back in their initial state goes back.
  • the introducer sheath may or may not be endowed with a memory effect in both its ductility and flexibility. Also, only individual areas of the introducer sheath can be equipped with a memory effect.
  • the introducer sheath has a funnel-shaped bodily ßeres end.
  • it can attach to this connections, for example, for a flush, gas, drug, contrast agents or other substances.
  • an insertion aid can be fastened to a ßä ßeren end of the introducer sheath.
  • Fastenable means the insertion can be connected to the body outer end and in particular be separated again from this.
  • the connection is preferably made by the insertion is introduced with the expansion member in the ßere ßere end, the expansion member initially expanded, then relaxed and withdrawn from the import lock.
  • the insertion aid is thereby preferably plastically deformed at least partially, so that a non-positive connection with the elastic lock end is formed.
  • the introducer may have a funnel-shaped opening and / or ports for adding gas, drugs, contrast agents or other substances.
  • the lock on her body ßer end has means for marking, with which the properties of the lock can be displayed.
  • the marking can be arranged on both channels or only on one of the two channels.
  • expandable means that the introducer sheath and / or the first channel increases in diameter elastically and / or by dissolution of at least one fold-like or meandering wall section. This advantageously ensures that the ratio between the unexpanded state, that is, the initial state and the expanded state of the introducer sheath, can be large.
  • the at least one second channel is formed by an indentation on a wall region of the first channel.
  • the indentation of one or more second channels takes place in particular during the production of the introducer sheath.
  • circular wall of the first channel is provided in sections or over the entire circumference with meandering recesses on the Au .seite whose openings are closed, arise around the first channel a plurality of second channels, extending by stretching the first Open channels.
  • the second channels may be lost, that is, the indentations do not reform again when the sluice is released.
  • an introducer sheath system with at least one introducer sheath according to the invention and with an introducer, which is arranged in the initial state in the second channel and is movable out of the introducer sheath by introducing an instrument into the first channel or into the second channel. to serve as an introduction instrument for another introducer sheath.
  • the introducer is a single-channel sheath, in particular a bendable and / or expandable single-channel sheath.
  • a cascade-like introducer sheath system is advantageously provided in which after a single puncture or a primary introduction through a natural body opening more introducer sheaths can be placed so that, if necessary, a lock system with a basically unlimited number of locks available.
  • the introducer sheath system is very efficient, because through some locks the actual intervention can take place by means of instruments and at the same time the transport of different substances can be carried out by other sheaths.
  • On the ßere ßere end can also be connected to an adjustable suction device. So one of the channels can serve as a sucker, the suction strength is adjustable.
  • Another advantage of such a lock system is that the individual locks of the system may have different diameters, materials and lengths.
  • the material of a Introducer sheath may be radiopaque, ie be visible in fluoroscopy.
  • three introducer sheaths may be provided for urological treatment purposes, with one sheath each for the three sebaceous septa.
  • an embodiment of an introducer sheath with a plurality of second channels may be provided.
  • the second channels are opened upon expansion of the introducer sheath by means of an instrument.
  • One use of the introducer sheath of the invention is also for access to joint cavities in which ligaments form a cavity, e.g. Knee puncture or knee-reflection, further for access to vertebral channels or gaps, i. to the cavity between spinal cord and dorsal shell and intervertebral disc, further for access to the cavity between brain and skullcap possible.
  • ligaments form a cavity
  • vertebral channels or gaps i. to the cavity between spinal cord and dorsal shell and intervertebral disc
  • introducer sheath according to the invention is also possible in technical fields, for example video investigations of drainage pipes or the like.
  • FIG. 1 shows a first embodiment of the introducer sheath
  • FIG. 2 shows a second embodiment of the introducer sheath
  • FIG. 3 shows a variant of the first embodiment of the introducer sheath
  • FIG. 4 shows a perspective view of an introducer sheath with a partially opened second channel
  • FIG. 5 shows a third embodiment of the introducer sheath.
  • Figures 6a and 6b show an embodiment of the introducer sheath with an insertion aid in cross section and in longitudinal section.
  • FIG. 7 shows an embodiment of an introducer sheath system.
  • FIG. 8 shows a fourth embodiment of the introducer sheath.
  • An introducer sheath 1 consists of a tubular body in which a first channel 2 and a second channel 3 are formed, which are separated by a wall portion 12.
  • a first channel 2 and a second channel 3 are formed, which are separated by a wall portion 12.
  • two wall regions 5, 6 are guided to one another in such a way that they lie against one another in the state of small clear width of the introducer sheath 1.
  • the second channel 3 is closed, wherein it does not need to be hermetically sealed via the separation point 4.
  • a predetermined breaking point can be provided between the two wall regions 5, 6 as separation point 4, which connects the two wall regions 5, 6 in a material-locking manner. It can be seen in FIG.
  • an instrument in the form of an expansion member 11 is partially inserted from the body-end 8 of the introducer sheath 1.
  • the introducer sheath 1 has been widened such that the second channel 3 has opened to the outside and releases an insertion instrument in the form of a wire 10, which has been pushed up in the second channel 3.
  • the wire 10 is one possible form of introducer.
  • the two wall regions 5, 6 have separated, so that the insertion wire 10 lying in the second channel 3 is partially released and can emerge from the second channel 3.
  • the expansion member may be, for example, a catheter, an optical device or a laser. It should be noted in all figures that the proportions are only sketchy reproduced.
  • the inner diameter of the first channel 2 in the state of small clear width of the introducer sheath 1 is greater or significantly larger than the inner diameter of the second channel 3.
  • the inner diameter of the second channel 3 is larger by 0.2 mm than the diameter of the instrument to be performed, which is the insertion wire 10 in FIG. 4, for example.
  • the difference between the first embodiment in FIG. 1 and the second embodiment in FIG. 2 lies in the way in which the two wall regions 5, 6 abut one another.
  • these two wall regions 5, 6 are designed to overlap, so that the separation point 4 is formed in this overlapping region.
  • This embodiment according to FIG. 2 can also be provided with a cohesive predetermined breaking point. This overlapping design in the region of the separation point 4 ensures that an instrument which is pushed upwards over a bend by the second channel 3 can not unintentionally escape from the second channel 3 to the outside.
  • the wall region 12, which separates the first channel 2 and the second channel 3 is designed as a meander-like wall section 9. This ensures that with a small clear width of the introducer sheath 1 a significant expansion of the outer diameter in the expanded state of the introducer sheath 1 can be achieved.
  • the wall region 12 may have greater extensibility than the outer wall of the introducer sheath 1, by a targeted force line in the direction of the second channel 3 to ensure.
  • the body end 8 of the introducer sheath 1 may be funnel-shaped (not shown), thereby facilitating the insertion of instruments.
  • connections may be made, for example, for flushing, gas, medication, contrast agents, or other means.
  • an adjustable suction device can be connected on the body end 8 . So one of the channels can serve as a sucker, the suction strength is adjustable.
  • the body-outer end 8 in the funnel-shaped or non-funnel-shaped variant can be equipped with the possibility (not shown) of setting markings which indicate to the operator which instruments have already advanced in the lock.
  • FIG. 4 An introducer sheath system results from the figure 4 in that by further advancing the expansion member 1 1, the second channel 3 is fully opened, i. loses, the insertion wire 10 is released to the outside and on this insertion wire 10, another lock next to the already lying lock 1 is pushed up.
  • This further lock may be a multi-channel lock according to the invention or a conventional lock. In the case in which a multi-channel lock according to the invention has been pushed up as a further lock, it can be exposed over this another time a lead-in wire from the second channel by expansion of the lock, so that this exposed wire can be repeatedly used to push up a lock.
  • the introducer sheath 1 may be provided with a bendable body-inner tip (not shown) which is actively movable by means of a conventional actuator (not shown).
  • the movable tip can be equipped with a memory effect, so that it resumes its starting position without being acted upon by the actuator.
  • FIG. 5 shows a third embodiment of the introducer sheath with two second channels 3, 3 '. All functional variants to the previously described embodiments can also be realized here. Furthermore, an unillustrated conceivable form in which circumferentially distributed around the first channel a plurality of second channels are arranged.
  • FIG. 6 a shows a further preferred embodiment of the introduction loop in cross section. This is connected to the body end with an insertion aid 14 which is inserted into the body outer end 8 of the introducer sheath 1.
  • Figure 6b illustrates the position of the parts to each other in a longitudinal section.
  • the deformation of the insertion 14 may in particular have a plastic portion, which creates a frictional connection with the end 8 of the elastic lock, which is just as easy to solve again.
  • the insertion aid 14 may have a funnel-shaped opening and / or ports for the addition of gas, drugs, contrast agents or other substances.
  • FIG. 7 shows an introducer sluice system according to the invention with an introducer sheath 1 according to the invention with two channels 2, 3, a bendable, expandable single-channel sheath being arranged as an introduction instrument 10 in the second channel 3.
  • a cascade-like introducer sphincter system is advantageously provided in which after a single puncture or a primary introduction through a natural body opening further introducer sheaths can be placed so that, if necessary, a lock system is available with a basically unlimited number of locks.
  • a fourth embodiment of the introducer sheath 1 is shown schematically in cross section.
  • the wall of the first channel 2 is provided with meandering recesses, which are directed radially from outside to inside, so that on the outside of the wall, a plurality of second channels 3 is formed.
  • the second channels 3 open at the separation points 4.
  • the indentations may lose in particular after the expansion, so that a cross-sectionally substantially round first channel 2 remains.

Abstract

L'invention concerne une gaine d'introduction (1) qui comporte, dans un état initial, au moins un premier canal (2) fermé sur sa périphérie et un deuxième canal (3).
PCT/EP2012/058237 2011-05-06 2012-05-04 Gaine d 'introduction extensible et système de gaine WO2012152689A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE201110050173 DE102011050173A1 (de) 2011-05-06 2011-05-06 Dehnbare Einführschleuse und Schleusensystem
DE102011050173.8 2011-05-06

Publications (1)

Publication Number Publication Date
WO2012152689A1 true WO2012152689A1 (fr) 2012-11-15

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Application Number Title Priority Date Filing Date
PCT/EP2012/058237 WO2012152689A1 (fr) 2011-05-06 2012-05-04 Gaine d 'introduction extensible et système de gaine

Country Status (2)

Country Link
DE (2) DE102011050173A1 (fr)
WO (1) WO2012152689A1 (fr)

Cited By (1)

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Publication number Priority date Publication date Assignee Title
CN105147234A (zh) * 2015-11-02 2015-12-16 王文一 喉部手术器械

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015193047A1 (fr) * 2014-06-17 2015-12-23 Biotronik Se & Co. Kg Gaine de guidage allongée

Citations (6)

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US5025778A (en) 1990-03-26 1991-06-25 Opielab, Inc. Endoscope with potential channels and method of using the same
US20030032941A1 (en) * 2001-08-13 2003-02-13 Boyle William J. Convertible delivery systems for medical devices
WO2003090834A2 (fr) * 2002-04-25 2003-11-06 The Board Of Trustees Of The Leland Stanford Junior University Gaine de guidage expansible et appareils et procedes faisant appel a ce type de gaine
US20050192532A1 (en) * 2004-01-29 2005-09-01 Kucklick Theodore R. Atraumatic arthroscopic instrument sheath
DE60220792T2 (de) 2001-03-27 2008-03-06 Exxonmobil Research And Engineering Co. Verfahren zur herstellung von dieselbrennstoff aus bitumen
EP0593181B1 (fr) 1992-10-09 2009-11-25 Cook Incorporated Gaines pour introduction

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US20090076484A1 (en) * 2004-10-22 2009-03-19 Kaneka Corporation Therapeutic Catheter
DE102006032583A1 (de) * 2006-07-13 2008-01-17 Biotronik Crm Patent Ag Einführvorrichtung
US8187222B2 (en) * 2008-09-12 2012-05-29 Boston Scientific Scimed, Inc. Devices and systems for delivery of therapeutic agents to body lumens
DE102008052752A1 (de) * 2008-10-22 2010-04-29 Medi-Globe Gmbh Katheter und Verfahren zu dessen Herstellung

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Publication number Priority date Publication date Assignee Title
US5025778A (en) 1990-03-26 1991-06-25 Opielab, Inc. Endoscope with potential channels and method of using the same
EP0593181B1 (fr) 1992-10-09 2009-11-25 Cook Incorporated Gaines pour introduction
DE60220792T2 (de) 2001-03-27 2008-03-06 Exxonmobil Research And Engineering Co. Verfahren zur herstellung von dieselbrennstoff aus bitumen
US20030032941A1 (en) * 2001-08-13 2003-02-13 Boyle William J. Convertible delivery systems for medical devices
WO2003090834A2 (fr) * 2002-04-25 2003-11-06 The Board Of Trustees Of The Leland Stanford Junior University Gaine de guidage expansible et appareils et procedes faisant appel a ce type de gaine
US20050192532A1 (en) * 2004-01-29 2005-09-01 Kucklick Theodore R. Atraumatic arthroscopic instrument sheath

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105147234A (zh) * 2015-11-02 2015-12-16 王文一 喉部手术器械

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DE102011050173A1 (de) 2012-11-08
DE202012012838U1 (de) 2014-01-29

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