WO2001070308A1 - Ensemble d'insertion de catheter dote d'une double valve hemostatique - Google Patents

Ensemble d'insertion de catheter dote d'une double valve hemostatique Download PDF

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Publication number
WO2001070308A1
WO2001070308A1 PCT/US2001/008511 US0108511W WO0170308A1 WO 2001070308 A1 WO2001070308 A1 WO 2001070308A1 US 0108511 W US0108511 W US 0108511W WO 0170308 A1 WO0170308 A1 WO 0170308A1
Authority
WO
WIPO (PCT)
Prior art keywords
valve
interventional element
blood
hemostatic
valves
Prior art date
Application number
PCT/US2001/008511
Other languages
English (en)
Inventor
Juan Carlos Parodi
Original Assignee
Arteria Medical Science, Inc.
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 Arteria Medical Science, Inc. filed Critical Arteria Medical Science, Inc.
Priority to AU2001249234A priority Critical patent/AU2001249234A1/en
Publication of WO2001070308A1 publication Critical patent/WO2001070308A1/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
    • 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
    • A61M39/0606—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof without means for adjusting the seal opening or pressure
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16K—VALVES; TAPS; COCKS; ACTUATING-FLOATS; DEVICES FOR VENTING OR AERATING
    • F16K15/00—Check valves
    • F16K15/14—Check valves with flexible valve members
    • F16K15/144—Check valves with flexible valve members the closure elements being fixed along all or a part of their periphery
    • F16K15/147—Check valves with flexible valve members the closure elements being fixed along all or a part of their periphery the closure elements having specially formed slits or being of an elongated easily collapsible form
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16K—VALVES; TAPS; COCKS; ACTUATING-FLOATS; DEVICES FOR VENTING OR AERATING
    • F16K15/00—Check valves
    • F16K15/18—Check valves with actuating mechanism; Combined check valves and actuated valves
    • F16K15/182—Check valves with actuating mechanism; Combined check valves and actuated valves with actuating mechanism
    • F16K15/1825—Check valves with actuating mechanism; Combined check valves and actuated valves with actuating mechanism for check valves with flexible valve members
    • 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
    • A61M2039/062—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof used with 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
    • A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
    • 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
    • A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
    • A61M2039/064—Slit-valve
    • 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
    • A61M2039/0686—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof comprising more than one seal

Definitions

  • Introducer devices and, more specifically, associated components are well known in the medical field for insertion into a cavity of the body, preferably into a blood vessel for introduction of medicines, prostheses, diagnostics, withdrawal of fluids, recanalization and many other treatment activities.
  • the sheath is hollow and is provided with a rear opening at a proximal end thereof to slidably receive the catheter and guide wires, which elements are inserted into the sheath through a proximal open end of the sheath and are moved into and out of the sheath to access the interior of the body.
  • a valve arrangement typically is provided at the proximal end. This valve arrangement usually includes a resilient seal or a manually operated seal, that keeps the rear opening normally closed and seals against the exterior surface of the element that is being inserted and moved within the sheath.
  • valves operate by sealing against a uniform and continuous outer cylindrical surface of the interventional element (e.g., introducer, catheter, guide wire) when these elements are disposed within the sheath.
  • the degree of sealing may not be adequate when a distal end of one of these elements is moved through the valve and out of the sheath.
  • the radially expanding seal of the valve does not continuously seal against the outer surface of the element being withdrawn from the sheath, and considerable blood leakage may result.
  • this blood loss may take the form of a spout or jet.
  • the number of sequential insertions and removals of such elements may result in bleeding that jeopardizes the patient's health.
  • valve arrangement and methods of use, that reduce the amount of air aspirated into the sheath during passage of instruments and guide wires through the valve arrangement .
  • an object of the present invention to provide an introducer device for inserting and manipulating instruments within a body cavity, with reduced blood loss.
  • an introducer assembly for insertion in a body for medical purposes, comprising a main flexible sheath for insertion into a blood vessel, the sheath having a distal end adapted for insertion into the vessel and a proximal end that remains outside the vessel, an introducer slidable longitudinally within the sheath, and a he ostatic valve arrangement at the proximal end of the sheath for sealingly receiving the introducer through the sheath, wherein the valve arrangement comprises at least two in-series connected valves.
  • FIG. 1 is a cross-sectional, side elevation view of a hemostatic valve in a previously known introducer device
  • FIG. 2 is a cross-sectional, side elevation view of the hemostatic valve of FIG. 1 during passage of an introducer through the valve;
  • FIG. 3 is a cross-sectional, side elevation view of an alternative hemostatic valve in a previously known introducer device
  • FIG. 4 is a cross-sectional, front elevation view of the iris-type sealing means of FIG. 3, taken along view line 4—4 of FIG. 3;
  • FIG. 5 is a cross-sectional, side elevation view of an embodiment of apparatus constructed in accordance with the present invention.
  • FIG. 6 is a cross-sectional, side elevation view of the valve arrangement of FIG. 5 during passage of an interventional element, such as an introducer;
  • FIG. 7 is a cross-sectional, side elevation view of the valve arrangement of FIG. 6 during withdrawal of the interventional element
  • FIG. 9 is a cross-sectional, side elevation view of an alternative embodiment of apparatus constructed in accordance with the present invention.
  • in-series connected valves refers to any two or more valves that are connected along a common flow path.
  • the outlet of one valve is in fluid communication with the inlet of the adjacent valve.
  • This fluid communication preferably includes a chamber designed to contain a limited amount of blood leaking from the inlet of the adjacent valve.
  • a previously known hemostatic valve is described that comprises vlave housing 1 having rear opening 2 and leading opening 3, sealed to sheath 4 for insertion into a cavity of the body, such as a blood vessel (not shown) .
  • seal 6 prevents egress of blood 5 from sheath 4.
  • an interventional element such as a catheter 7
  • the seal resiliently opens as long as it is resiliently expanded at the center thereof by catheter tip 8. Lips 9 of seal 6 remain in contact against the exterior of catheter 7, thus no leakage past seal 6 occurs.
  • lips 9 of seal 6 can behave unpredictably because the same are carried backwards by the catheter and cannot maintain an adequate seal against the catheter, often producing a sudden blood leakage, such as a blood jet.
  • This leakage referred to as "back bleeding,” occasionally is sufficiently forceful to spray surgery personnel, with obvious risk of contagion to the personnel.
  • Such jets may also result in excessive blood loss to the patient.
  • FIG. 3 depicts a previously known valve comprising valve housing 10 having rear opening 11 and leading opening 12 to which sheath 13 is connected. Seal 14 is mounted in the interior of the housing to permit passage of an interventional element, such as catheter 7, through the valve with reduced blood leakage.
  • Seal 14 comprises an iris-type seal formed by a plurality of sealing plates 15 capable of being closed and opened using manually operated ring 16.
  • ring 16 When catheter 7 is to be inserted through the seal, ring 16 is actuated to open the iris arrangement to- * form a passage of adequate diameter to receive catheter 7, indicated by dashed lines 17 in FIG. 4.
  • the ring which may be provided with ribs 18 to facilitate operation, must be quickly operated to close the passage (as indicated by center 19) once the catheter has been removed.
  • This maneuver is complex, and blood often passes through the valve, resulting in considerable back bleeding. In cases where the surgical operation is of relatively short duration, the back bleeding does not result in a significant loss of blood for the patient.
  • the volume of blood lost during the operation due to the exchange of elements through the hemostatic valve may be so excessive that the life of the patient may be endangered.
  • a dual hemostatic valve arrangement illustrated in FIGS. 5-8, is provided.
  • the valve arrangement of the present invention comprises housing valve 20 having an opening at proximal end 21, and an opening at distal end 22.
  • Distal end 22 is sealed in fluid communication to proximal end 23 of sheath 24, which has a distal end (not shown) inserted into a blood vessel (not shown) .
  • Sealing means preferably comprises a pair of disc-like seals 25 and 26, that are mounted in the interior of the valve housing. Seals 25 and 26 operate and/or form two in-series connected valves defining an intermediate chamber 27, which limits blood leakage from seal 26.
  • Seals 25 and 26 may be made of any suitable biomedical material and preferably are fixed to the interior of valve housing 20 using techniques well known in the art.
  • seals 25 and 26 may be fixed to housing 20 by adhesives or hot welding, or may be embedded or housed in a groove formed in the inner surface of the housing. Any of these techniques may be adapted for desired manufacturing and assembly procedures.
  • an interventional element such as a catheter, introducer or guide wire
  • provision of an intermediate chamber is expected to substantially reduce blood leakage through outermost seal 25.
  • tip 8 of element 7 is passed through seal 25, as shown in FIG. 8, spillage of blood through seal 26 is stopped, and little or no leakage occurs at seal 25.
  • the blood in chamber 27 operates as a pressure absorber, forming a hydraulic stopper or plug that reduces spillage through seal 25.

Landscapes

  • Engineering & Computer Science (AREA)
  • General Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention se rapporte à un ensemble d'insertion et à des procédés d'utilisation d'un tel ensemble. Ledit ensemble comporte une gaine souple principale (24) conçue pour être insérée dans un vaisseau sanguin et dotée d'une extrémité proximale (23) comprenant un agencement à deux valves (25, 26).
PCT/US2001/008511 2000-03-20 2001-03-15 Ensemble d'insertion de catheter dote d'une double valve hemostatique WO2001070308A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2001249234A AU2001249234A1 (en) 2000-03-20 2001-03-15 Catheter introducer assembly with dual hemostatic valve

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US52854800A 2000-03-20 2000-03-20
US09/528,548 2000-03-20

Publications (1)

Publication Number Publication Date
WO2001070308A1 true WO2001070308A1 (fr) 2001-09-27

Family

ID=24106131

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2001/008511 WO2001070308A1 (fr) 2000-03-20 2001-03-15 Ensemble d'insertion de catheter dote d'une double valve hemostatique

Country Status (2)

Country Link
AU (1) AU2001249234A1 (fr)
WO (1) WO2001070308A1 (fr)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8267897B2 (en) 2010-01-06 2012-09-18 W. L. Gore & Associates, Inc. Center twist hemostatic valve
US8945059B2 (en) 2009-01-30 2015-02-03 W. L. Gore & Associates, Inc. Medical apparatus and method of making the same
US9044581B2 (en) 2012-03-19 2015-06-02 Cook Medical Technologies Llc Medical devices, methods, and kits for delivering medication to a bodily passage
WO2015168006A1 (fr) * 2014-04-28 2015-11-05 Edwards Lifesciences Corporation Dispositifs d'introduction intravasculaire
US9314593B2 (en) 2012-09-24 2016-04-19 Cook Medical Technologies Llc Medical devices for the identification and treatment of bodily passages
US9833130B2 (en) 2011-07-22 2017-12-05 Cook Medical Technologies Llc Irrigation devices adapted to be used with a light source for the identification and treatment of bodily passages
US9895055B2 (en) 2013-02-28 2018-02-20 Cook Medical Technologies Llc Medical devices, systems, and methods for the visualization and treatment of bodily passages
US9937323B2 (en) 2014-02-28 2018-04-10 Cook Medical Technologies Llc Deflectable catheters, systems, and methods for the visualization and treatment of bodily passages
US10195398B2 (en) 2014-08-13 2019-02-05 Cook Medical Technologies Llc Tension member seal and securing mechanism for medical devices
EP4173668A1 (fr) * 2021-10-28 2023-05-03 Biosense Webster (Israel) Ltd Système de soupape composite pour outils intracardiaques

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5009391A (en) * 1988-05-02 1991-04-23 The Kendall Company Valve assembly
US5405323A (en) * 1994-02-22 1995-04-11 Aeroquip Corporation Catheter check valve assembly

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5009391A (en) * 1988-05-02 1991-04-23 The Kendall Company Valve assembly
US5405323A (en) * 1994-02-22 1995-04-11 Aeroquip Corporation Catheter check valve assembly

Cited By (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8945059B2 (en) 2009-01-30 2015-02-03 W. L. Gore & Associates, Inc. Medical apparatus and method of making the same
US8267897B2 (en) 2010-01-06 2012-09-18 W. L. Gore & Associates, Inc. Center twist hemostatic valve
US9980631B2 (en) 2011-07-22 2018-05-29 Cook Medical Technologies Llc Irrigation devices adapted to be used with a light source for the identification and treatment of bodily passages
US9833130B2 (en) 2011-07-22 2017-12-05 Cook Medical Technologies Llc Irrigation devices adapted to be used with a light source for the identification and treatment of bodily passages
US9586034B2 (en) 2012-03-19 2017-03-07 Cook Medical Technologies Llc Medical devices, methods, and kits for delivering medication to a bodily passage
US10188828B2 (en) 2012-03-19 2019-01-29 Cook Medical Technologies Llc Medical devices, methods, and kits for delivering medication to a bodily passage
US9592370B2 (en) 2012-03-19 2017-03-14 Cook Medical Technologies Llc Medical devices, methods, and kits for delivering medication to a bodily passage
US11045625B2 (en) 2012-03-19 2021-06-29 Cook Medical Technologies Llc Medical devices, methods, and kits for delivering medication to a bodily passage
US9044581B2 (en) 2012-03-19 2015-06-02 Cook Medical Technologies Llc Medical devices, methods, and kits for delivering medication to a bodily passage
US9314593B2 (en) 2012-09-24 2016-04-19 Cook Medical Technologies Llc Medical devices for the identification and treatment of bodily passages
US10426925B2 (en) 2012-09-24 2019-10-01 Cook Medical Technologies Llc Medical devices for the identification and treatment of bodily passages
US9895055B2 (en) 2013-02-28 2018-02-20 Cook Medical Technologies Llc Medical devices, systems, and methods for the visualization and treatment of bodily passages
US9937323B2 (en) 2014-02-28 2018-04-10 Cook Medical Technologies Llc Deflectable catheters, systems, and methods for the visualization and treatment of bodily passages
US10814098B2 (en) 2014-02-28 2020-10-27 Cook Medical Technologies Llc Deflectable catheters, systems, and methods for the visualization and treatment of bodily passages
US10154904B2 (en) 2014-04-28 2018-12-18 Edwards Lifesciences Corporation Intravascular introducer devices
JP2020014887A (ja) * 2014-04-28 2020-01-30 エドワーズ ライフサイエンシーズ コーポレイションＥｄｗａｒｄｓ Ｌｉｆｅｓｃｉｅｎｃｅｓ Ｃｏｒｐｏｒａｔｉｏｎ 血管内導入器デバイス
WO2015168006A1 (fr) * 2014-04-28 2015-11-05 Edwards Lifesciences Corporation Dispositifs d'introduction intravasculaire
US11123188B2 (en) 2014-04-28 2021-09-21 Edwards Lifesciences Corporation Intravascular introducer devices
US11998448B2 (en) 2014-04-28 2024-06-04 Edwards Lifesciences Corporation Intravascular introducer devices
US10195398B2 (en) 2014-08-13 2019-02-05 Cook Medical Technologies Llc Tension member seal and securing mechanism for medical devices
EP4173668A1 (fr) * 2021-10-28 2023-05-03 Biosense Webster (Israel) Ltd Système de soupape composite pour outils intracardiaques

Also Published As

Publication number Publication date
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