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WO2000006241A1 - Device for introducing catheters into a blood vessel of a patient - Google Patents

Device for introducing catheters into a blood vessel of a patient Download PDF

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Publication number
WO2000006241A1
WO2000006241A1 PCT/ES1999/000241 ES9900241W WO0006241A1 WO 2000006241 A1 WO2000006241 A1 WO 2000006241A1 ES 9900241 W ES9900241 W ES 9900241W WO 0006241 A1 WO0006241 A1 WO 0006241A1
Authority
WO
WIPO (PCT)
Prior art keywords
proximal
introducer sheath
head
patient
branches
Prior art date
Application number
PCT/ES1999/000241
Other languages
Spanish (es)
French (fr)
Inventor
Alfonso Medina Fernandez-Aceituno
Original Assignee
Medina Fernandez Aceituno Alfo
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 Medina Fernandez Aceituno Alfo filed Critical Medina Fernandez Aceituno Alfo
Publication of WO2000006241A1 publication Critical patent/WO2000006241A1/en

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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/065—Guide needles
    • 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
    • A61M2039/0646—Duckbill-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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • 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

Definitions

  • the invention relates to a device for introducing catheters into a patient's blood vessel, said device comprising an introducer sheath that has a distal end and a proximal end and is traversible by a dilator.
  • the use of the aforementioned devices comprises the following steps: a percutaneous puncture is performed with a needle and through it a wire guide is passed, then removing the needle; the guide is inserted into a dilator in which the introduction device is mounted, until it penetrates the vessel; when removing the dilator and the guide, the device is ready to be used for the passage of a catheter.
  • the invention aims to overcome the aforementioned drawbacks.
  • This purpose is achieved by a device of the type indicated at the beginning and characterized in that said proximal end! of said introducer sheath is continued by a head provided with at least two proximal tubular branches, each of said proximal tubular branches: [a] presenting a proximal access mouth; [b] being communicated with said introducer sheath; and [c] being provided with a hemostasis valve; and because one of said proximal tubular branches is aligned with said introducer sheath, allowing said dilator access to said sheath.
  • the device can be applied in electrophysiology and other vascular techniques (pressure measurement in two or more places) as well as it can be applied in percutaneous procedures in different anatomical places (laparoscopic surgery) by modifying the current introducer trocars.
  • Another important field of application is intensive care, in which the device can remain in the patient for a long number of days.
  • Fig. 1 an elevation view of the device provided with three proximal tubular branches.
  • Fig. 2 a view similar to the previous one with the dilator going through the device.
  • Fig. 3 a view analogous to the previous ones being the device crossed by three catheters.
  • Fig. 4 an exploded partial section, on a larger scale, of the head, the tubular branches and the fixing system.
  • Fig. 5 a view analogous to those of Figs. 1 to 3 corresponding to an embodiment in which the introducer sheath and the head are different pieces.
  • Fig. 6 on a larger scale, a side elevation view, partially sectioned, of a preferred embodiment of the hemostasis valve.
  • the present device comprises an introducer sheath 2 with a distal end 4 (ie the end to be inserted in the patient and away from the person acting with the device) and a proximal end 6 (opposite to said distal end). From this proximal end there is a head 8 that can constitute a single piece with the introducer sheath 2 or be fixedly attached to the sheath 2.
  • the head 8 is provided with two or more proximal tubular branches 10 (three branches 10a, 10b and 10c in the embodiment shown) and one of them, in the figures the proximal branch 10a, is aligned with the introducer sheath 2 and is substantially of the same caliber, so that the device can be traversed end to end by a dilator 12 (Fig. 2); all the tubular branches 10 are communicated with the introducer sheath 2 and are also accessible by the respective proximal access mouths 14a, 14b and 14c, so that this mouth 14 can be pierced by a catheter 16 (Fig. 3); previously one of said proximal mouths 14 has been crossed by a wire guide (not shown) and which is useful for the correct placement of the device in a blood vessel.
  • Each of the tubular branches 10 has a hemostasis valve 18 (Figs. 4 and 6) that opens when it is traversed by a catheter 16 although it hinders an unwanted reflux of blood from the blood vessel that has been penetrated.
  • the device has a side tube 20 that is connected to a tubular branch 10 (tubular branch 10a, in the embodiment described and represented);
  • This side tube 20 is provided with connection means 22, which is preferably a Luer connection, which allows communication with a syringe or with an extension connected to a serum container or other devices.
  • the invention also comprises the possibility that there is a side tube and corresponding connection means 22 for each tubular branch 10; the connection 24 (Fig. 4) of the side tube 20 with the tubular branch 10 takes place downstream of the corresponding hemostasis valve 18.
  • the connection means 22 allows manual washing with a syringe, aspirating blood and re-injecting blood and serum to the patient, in order to remove air from the system prior to catheter insertion.
  • the device comprises fixing fins 26 provided with two holes 28 that allow a fastening with lines or the like, so that a catheter immobilization with respect to the patient is achieved.
  • each system 30 comprises a proximal section 32 located upstream with respect to the hemostasis valve 18; this section 32 is externally threaded and a small tubular element 34 of elastic material is freely housed therein; preferably the outer lateral surface of the tubular element 34 is concave.
  • the proximal section 32 is closed by means of a cap 36 as a cap, internally threaded and which is threadable to the proximal section 32.
  • This cap 36 has an internal axial rod 38 which has an axial hole 40.
  • the mouth of the plug 36 constitutes the proximal mouth 14 for access to the tubular element and it is preferred that the edge of this mouth be rounded or of a truncated conical configuration.
  • a preferred embodiment of the hemostasis valve 18 is shown on a larger scale, which is of special application in the proximal branch 10a aligned with the introducer sheath 2;
  • This hemostasis valve 18 is formed by a body of flexible plastic material. It comprises an upper circular base 42 at the center of which is a hole 44; From this base emerges a brief descending peripheral skirt 46 that surrounds a resistant ring 48.
  • the lower part of this hemostasis valve 18 has an ascending skirt which fits into said descending peripheral skirt 46 and a centrifugal radial part 50; of these two flat portions 52 continue, as sections of a cone by inclined planes; these portions have free edges 54 that tend to keep in contact, and which are separated when the hemostasis valve is crossed by the dilator 12.

Landscapes

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

Abstract

Device for the introduction of catheters into the blood vessel of a patient, comprising an introduction sheath which has a distal extremity and a proximal extremity and which can be traversed by an expander, said proximal extremity being provided with a head having at least two tubular proximal branches, each of said branches (a) presenting a proximal access mouth, (b) communicating with the introduction sheath and (c) being provided with a haemostasia valve; and wherein one of the tubular proximal branches is aligned with the introduction sheath, thereby enabling the access of the expander into the introduction sheath.

Description

DISPOSITIVO PARA INTRODUCCIÓN DE CATÉTERES EN UN VASO SANGUÍNEO DE UN PACIENTE DEVICE FOR INTRODUCTION OF CATHETERS IN A PATIENT'S BLOOD GLASS
D E S C R I P C I Ó ND E S C R I P C I Ó N
Campo de la InvenciónField of the Invention
La invención se refiere a un dispositivo para introducción de catéteres en un vaso sanguíneo de un paciente, dicho dispositivo comprendiendo una vaina introductora que presenta un extremo distal y un extremo proximal y que es atravesable por un dilatador.The invention relates to a device for introducing catheters into a patient's blood vessel, said device comprising an introducer sheath that has a distal end and a proximal end and is traversible by a dilator.
Referencia a la técnica anteriorReference to prior art
Como es sabido, la utilización de los referidos dispositivos comprende los siguientes pasos: se efectúa una punción percutánea con una aguja y a través de la misma se hace pasar una guía de alambre, retirando la aguja a continuación; la guía se introduce en un dilatador en el que está montado el dispositivo de introducción, hasta que penetre en el vaso; al retirar el dilatador y la guía, el dispositivo queda en disposición de ser utilizado para el paso de un catéter.As is known, the use of the aforementioned devices comprises the following steps: a percutaneous puncture is performed with a needle and through it a wire guide is passed, then removing the needle; the guide is inserted into a dilator in which the introduction device is mounted, until it penetrates the vessel; when removing the dilator and the guide, the device is ready to be used for the passage of a catheter.
No obstante estos dispositivos para introducción de catéteres habitualmente conocidos obligan a una nueva punción para cada catéter que se desee introducir.However, these devices for the introduction of commonly known catheters require a new puncture for each catheter to be introduced.
Sumario de la invenciónSummary of the invention
La invención se propone superar los inconvenientes citados. Esta finalidad se consigue mediante un dispositivo del tipo indicado al principio y que está caracterizado porque dicho extremo próxima! de dicha vaina introductora está continuado por una cabeza dotada de por lo menos dos ramas tubulares proximales, cada una de dichas ramas tubulares proximales: [a] presentando una boca proximal de acceso; [b] estando comunicada con dicha vaina introductora; y [c] estando dotada de una válvula de hemostasia; y porque una de dichas ramas tubulares proximales está alineada con dicha vaina introductora, permitiendo el acceso de dicho dilatador a dicha vaina.The invention aims to overcome the aforementioned drawbacks. This purpose is achieved by a device of the type indicated at the beginning and characterized in that said proximal end! of said introducer sheath is continued by a head provided with at least two proximal tubular branches, each of said proximal tubular branches: [a] presenting a proximal access mouth; [b] being communicated with said introducer sheath; and [c] being provided with a hemostasis valve; and because one of said proximal tubular branches is aligned with said introducer sheath, allowing said dilator access to said sheath.
Con el dispositivo objeto de la invención, se hace posible que tras una inserción similar a la descrita, sea posible introducir a su través varios catéteres que a su vez pueden ser manipulados individualmente sin que ello comprometa la estabilidad de los previamente introducidos y sin que se produzca reflujo.With the device object of the invention, it is possible that after an insertion similar to that described, it is possible to introduce several catheters through which can be manipulated individually without compromising the stability of the previously introduced ones and without produce reflux.
El dispositivo puede ser aplicado en electrofisiología y otras técnicas vasculares (medición de presión en dos o más lugares) así como puede ser aplicado en procedimientos percutáneos en diferentes lugares anatómicos (cirugía laparoscópica) modificando los trocares introductores actuales. Otro importante campo de aplicación son los cuidados intensivos, en los que el dispositivo puede permanecer en el paciente durante un largo número de días.The device can be applied in electrophysiology and other vascular techniques (pressure measurement in two or more places) as well as it can be applied in percutaneous procedures in different anatomical places (laparoscopic surgery) by modifying the current introducer trocars. Another important field of application is intensive care, in which the device can remain in the patient for a long number of days.
Breve descripción de los dibujosBrief description of the drawings
Otras ventajas y características de la invención se aprecian a partir de la siguiente descripción, en la qué, sin ningún carácter limitativo, se relata un modo preferente de realización de la invención, haciendo mención de los dibujos que se acompañan. Las figuras muestran:Other advantages and features of the invention can be seen from the following description, in which, without any limitation, a preferred embodiment of the invention is mentioned, mentioning the accompanying drawings. The figures show:
Fig. 1, una vista en alzado del dispositivo dotado de tres ramas tubulares proximales.Fig. 1, an elevation view of the device provided with three proximal tubular branches.
Fig. 2, una vista análoga a la anterior con el dilatador atravesando el dispositivo. Fig. 3, una vista análoga a las anteriores estando el dispositivo atravesado por tres catéteres.Fig. 2, a view similar to the previous one with the dilator going through the device. Fig. 3, a view analogous to the previous ones being the device crossed by three catheters.
Fig. 4, una sección parcial explosionada, a mayor escala, de la cabeza, las ramas tubulares y el sistema de fijación. Fig. 5, una vista análoga a las de las Figs. 1 a 3 correspondiente a un modo de realización en el que la vaina introductora y la cabeza son piezas distintas.Fig. 4, an exploded partial section, on a larger scale, of the head, the tubular branches and the fixing system. Fig. 5, a view analogous to those of Figs. 1 to 3 corresponding to an embodiment in which the introducer sheath and the head are different pieces.
Fig. 6, a mayor escala, una vista en alzado lateral, parcialmente seccionada, de un modo preferente de realización de la válvula de hemostasia.Fig. 6, on a larger scale, a side elevation view, partially sectioned, of a preferred embodiment of the hemostasis valve.
Descripción detallada de la invenciónDetailed description of the invention
El presente dispositivo comprende una vaina introductora 2 con un extremo distal 4 (o sea el extremo a insertar en el paciente y alejado de la persona que actúa con el dispositivo) y un extremo proximal 6 (opuesto al citado extremo distal). A partir de este extremo proximal se encuentra una cabeza 8 que puede constituir una sola pieza con la vaina introductora 2 o estar unida fijamente a la vaina 2.The present device comprises an introducer sheath 2 with a distal end 4 (ie the end to be inserted in the patient and away from the person acting with the device) and a proximal end 6 (opposite to said distal end). From this proximal end there is a head 8 that can constitute a single piece with the introducer sheath 2 or be fixedly attached to the sheath 2.
La cabeza 8 está dotada de dos o más ramas tubulares proximales 10 (tres ramas 10a, 10b y 10c en el ejemplo de realización que se ha representado) y una de ellas, en las figuras la rama proximal 10a, está alineada con la vaina introductora 2 y es substancialmente del mismo calibre, de manera que el dispositivo pueda ser atravesado de extremo a extremo por un dilatador 12 (Fig. 2); todas las ramas tubulares 10 se hallan comunicada con la vaina introductora 2 y además son accesibles por las respectivas bocas proximales de acceso 14a, 14b y 14c, de manera que esta boca 14 puede ser atravesada por un catéter 16 (Fig. 3); previamente una de dichas bocas proximales 14 ha sido atravesada por una guía de alambre (no representada) y que es útil para la correcta colocación del dispositivo en un vaso sanguíneo.The head 8 is provided with two or more proximal tubular branches 10 (three branches 10a, 10b and 10c in the embodiment shown) and one of them, in the figures the proximal branch 10a, is aligned with the introducer sheath 2 and is substantially of the same caliber, so that the device can be traversed end to end by a dilator 12 (Fig. 2); all the tubular branches 10 are communicated with the introducer sheath 2 and are also accessible by the respective proximal access mouths 14a, 14b and 14c, so that this mouth 14 can be pierced by a catheter 16 (Fig. 3); previously one of said proximal mouths 14 has been crossed by a wire guide (not shown) and which is useful for the correct placement of the device in a blood vessel.
Cada una de las ramas tubulares 10 dispone de una válvula de hemostasia 18 (Figs. 4 y 6) que se abre al ser atravesada por una catéter 16 si bien dificulta un indeseado reflujo de sangre procedente del vaso sanguíneo que ha sido objeto de penetración. La válvula de hemostasia 18 correspondiente a la rama proximal 10a alineada con la vaina introductora, debe tener un correcto funcionamiento tanto cuando es atravesada por un catéter 16, como cuando es atravesada por un dilatador 12.Each of the tubular branches 10 has a hemostasis valve 18 (Figs. 4 and 6) that opens when it is traversed by a catheter 16 although it hinders an unwanted reflux of blood from the blood vessel that has been penetrated. The hemostasis valve 18 corresponding to the proximal branch 10a aligned with the introducer sheath, it must have a correct functioning both when it is crossed by a catheter 16, and when it is crossed by a dilator 12.
En la realización que se describe y representa, el dispositivo presenta un tubo lateral 20 que está conectado con una rama tubular 10 (rama tubular 10a, en el modo de realización que se describe y representa); este tubo lateral 20 está dotado de unos medios de conexión 22, que preferentemente es una conexión Luer, que permite establecer comunicación con una jeringa o con una alargadera relacionada con un contenedor de suero o con otros dispositivos. La invención también comprende la posibilidad que exista un tubo lateral y correspondientes medios de conexión 22 para cada rama tubular 10; la conexión 24 (Fig. 4) del tubo lateral 20 con la rama tubular 10 tiene lugar aguas abajo de la correspondiente válvula de hemostasia 18. Durante la utilización del dispositivo, los medios de conexión 22 permiten el lavado manual con jeringa, aspirando sangre y reinyectando sangre y suero al paciente, con el objeto de eliminar el aire del sistema previamente a la inserción del catéter.In the embodiment described and represented, the device has a side tube 20 that is connected to a tubular branch 10 (tubular branch 10a, in the embodiment described and represented); This side tube 20 is provided with connection means 22, which is preferably a Luer connection, which allows communication with a syringe or with an extension connected to a serum container or other devices. The invention also comprises the possibility that there is a side tube and corresponding connection means 22 for each tubular branch 10; the connection 24 (Fig. 4) of the side tube 20 with the tubular branch 10 takes place downstream of the corresponding hemostasis valve 18. During the use of the device, the connection means 22 allows manual washing with a syringe, aspirating blood and re-injecting blood and serum to the patient, in order to remove air from the system prior to catheter insertion.
También es preferente que el dispositivo comprenda unas aletas de fijación 26 dotadas de sendos orificios 28 que permiten una sujeción con sedales o similares, de manera que se consiga una inmovilización del catéter con respecto al paciente.It is also preferable that the device comprises fixing fins 26 provided with two holes 28 that allow a fastening with lines or the like, so that a catheter immobilization with respect to the patient is achieved.
Se prevé que el dispositivo esté dotado también de sistemas de fijación 30 para los catéteres; cada sistema 30 (Fig. 4) comprende un tramo proximal 32 situado aguas arriba con respecto a la válvula de hemostasia 18; este tramo 32 está roscado exteriormente y en su interior se aloja libremente un pequeño elemento tubular 34 de material elástico; preferentemente la superficie lateral externa del elemento tubular 34 es cóncava. El tramo proximal 32 se cierra por medio de un tapón 36 a modo de capuchón, roscado interiormente y que es roscable al tramo proximal 32. Este tapón 36 dispone de un vastago axial interno 38 que presenta un orificio 40 también axial. En esta realización preferente, la boca del tapón 36 constituye la boca proximal 14 de acceso al elemento tubular y es preferente que el borde de esta boca sea redondeado o de configuración troncocónica. Al introducir un catéter 16, éste atraviesa el orificio 40, el elemento tubular 34 y el propio tramo proximal 32; en esta situación se rosca fuertemente el tapón 36, con lo que el vastago axial 38 ocasiona la deformación del pequeño elemento tubular 34, de manera que esta deformación conduce a una inmovilización del catéter que facilita su estabilización, a fin de que permanezca inmóvil cuando se manipula otra catéter introducido a través de otra rama tubular proximal 10It is envisioned that the device is also provided with fixing systems 30 for catheters; each system 30 (Fig. 4) comprises a proximal section 32 located upstream with respect to the hemostasis valve 18; this section 32 is externally threaded and a small tubular element 34 of elastic material is freely housed therein; preferably the outer lateral surface of the tubular element 34 is concave. The proximal section 32 is closed by means of a cap 36 as a cap, internally threaded and which is threadable to the proximal section 32. This cap 36 has an internal axial rod 38 which has an axial hole 40. In this preferred embodiment, the mouth of the plug 36 constitutes the proximal mouth 14 for access to the tubular element and it is preferred that the edge of this mouth be rounded or of a truncated conical configuration. When introducing a catheter 16, it passes through the hole 40, the tubular element 34 and the proximal section 32 itself; in this situation, the plug 36 is screwed tightly, whereby the axial rod 38 causes the deformation of the small tubular element 34, so that this deformation leads to an immobilization of the catheter that facilitates its stabilization, so that it remains immobile when manipulates another catheter inserted through another proximal tubular branch 10
En la Fig. 6 se representa a mayor escala un modo preferente de realización de la válvula de hemostasia 18, que es de especial aplicación en la rama proximal 10a alineada con la vaina introductora 2; esta válvula de hemostasia 18 está formada por un cuerpo de material plástico flexible. Comprende una base circular superior 42 en cuyo centro se halla un orificio 44; de esta base emerge un breve faldón periférico descendente 46 que envuelve un anillo resistente 48. La parte inferior de esta válvula de hemostasia 18 dispone de un faldón ascendente que encaja en el citado faldón periférico descendente 46 y una parte radial centrífuga 50; de éstas continúan dos porciones planas 52, a modo de secciones de un cono por planos inclinados; estas porciones presentan sendos bordes libres 54 que tienden a mantenerse en contacto, y que son separados cuando la válvula de hemostasia es atravesada por el dilatador 12. In Fig. 6 a preferred embodiment of the hemostasis valve 18 is shown on a larger scale, which is of special application in the proximal branch 10a aligned with the introducer sheath 2; This hemostasis valve 18 is formed by a body of flexible plastic material. It comprises an upper circular base 42 at the center of which is a hole 44; From this base emerges a brief descending peripheral skirt 46 that surrounds a resistant ring 48. The lower part of this hemostasis valve 18 has an ascending skirt which fits into said descending peripheral skirt 46 and a centrifugal radial part 50; of these two flat portions 52 continue, as sections of a cone by inclined planes; these portions have free edges 54 that tend to keep in contact, and which are separated when the hemostasis valve is crossed by the dilator 12.

Claims

R E I V I N D I C A C I O N E S
1.- Dispositivo para introducción de catéteres en un vaso sanguíneo de un paciente, dicho dispositivo comprendiendo una vaina introductora (2) que presenta un extremo distal (4) y un extremo proximal (6) y que es atravesable por un dilatador (12), caracterizado porque dicho extremo proximal (6) de dicha vaina introductora (2) está continuado por una cabeza (8) dotada de por lo menos dos ramas tubulares proximales (10), cada una de dichas ramas tubulares proximales (10): [a] presentando una boca proximal de acceso (14); [b] estando comunicada con dicha vaina introductora (2); y [c] estando dotada de una válvula de hemostasia (18); y porque una de dichas ramas tubulares proximales (10) está alineada con dicha vaina introductora (2), permitiendo el acceso de dicho dilatador (12) a dicha vaina introductora (2).1. Device for introducing catheters into a patient's blood vessel, said device comprising an introducer sheath (2) having a distal end (4) and a proximal end (6) and which is traversible by a dilator (12) , characterized in that said proximal end (6) of said introducer sheath (2) is continued by a head (8) provided with at least two proximal tubular branches (10), each of said proximal tubular branches (10): [a ] presenting a proximal access mouth (14); [b] being communicated with said introducer sheath (2); and [c] being provided with a hemostasis valve (18); and because one of said proximal tubular branches (10) is aligned with said introducer sheath (2), allowing said dilator (12) access to said introducer sheath (2).
2.- Dispositivo según la reivindicación 1 , caracterizado porque dicha vaina introductora (2) y dicha cabeza (8) constituyen una sola pieza.2. Device according to claim 1, characterized in that said introducer sheath (2) and said head (8) constitute a single piece.
3.- Dispositivo según la reivindicación 1 , caracterizado porque dicha vaina introductora (2) y dicha cabeza (8) constituyen dos piezas distintas aptas para ser unidas fijamente.3. Device according to claim 1, characterized in that said introducer sheath (2) and said head (8) constitute two distinct pieces suitable for being fixedly joined.
4.- Dispositivo según por lo menos una de las reivindicaciones 1 a 3, caracterizado porque por lo menos una de dichas válvulas de hemostasia (18) está constituida por un cuerpo de material plástico flexible, que comprende: una base circular superior (42), en la que se encuentra un orificio (44) centrado, y que presenta un breve faldón periférico descendente (46), que envuelve un anillo resistente (48); y una parte inferior provista de un faldón ascendente apto para encajar en dicho faldón periférico descendente (46) y que está continuado por dos porciones planas (52), en mutua inclinación y que presentan sendos bordes libres (54) que tienden a mantenerse en contacto. 4. Device according to at least one of claims 1 to 3, characterized in that at least one of said hemostasis valves (18) is constituted by a body of flexible plastic material, comprising: an upper circular base (42) , in which there is a centered hole (44), and which has a brief descending peripheral skirt (46), which surrounds a resistant ring (48); and a lower part provided with an ascending skirt suitable for fitting in said descending peripheral skirt (46) and which is continued by two flat portions (52), in mutual inclination and having two free edges (54) that tend to keep in contact .
5.- Dispositivo según por lo menos una de las reivindicaciones 1 a5. Device according to at least one of claims 1 to
4, caracterizado porque por lo menos una de dichas ramas tubulares proximales (10) está en comunicación, aguas abajo de dicha válvula de hemostasia (18), con un tubo lateral (20) dotado de medios de conexión (22).4, characterized in that at least one of said proximal tubular branches (10) is in communication, downstream of said hemostasis valve (18), with a side tube (20) provided with connection means (22).
6.- Dispositivo según por lo menos una de las reivindicaciones 1 a6. Device according to at least one of claims 1 to
5, caracterizado porque por lo menos una de dichas ramas tubulares proximales (10) dispone de un sistema de fijación (30) apto para fijar un catéter (16) introducido en la rama, dicho sistema de fijación (30) estando acoplado a dicha boca proximal de acceso (14).5, characterized in that at least one of said proximal tubular branches (10) has a fixing system (30) suitable for fixing a catheter (16) inserted in the branch, said fixing system (30) being coupled to said mouth proximal access (14).
7.- Dispositivo según la reivindicación 6, caracterizado porque dicho sistema de fijación (30) comprende: un tramo proximal (32) situado aguas arriba con respecto a dicha válvula de hemostasia (18) y roscado exteriormente; un elemento tubular (34) elástico, alojado libremente en dicho tramo proximal (32); y un tapón (36) a modo de capuchón, dotado de un vastago axial (38) horadado axialmente y roscable a dicho tramo proximal hasta una posición de roscado en la que deforma dicho elemento tubular elástico.7. Device according to claim 6, characterized in that said fixing system (30) comprises: a proximal section (32) located upstream with respect to said hemostasis valve (18) and externally threaded; an elastic tubular element (34), freely housed in said proximal section (32); and a cap (36) as a cap, provided with an axial rod (38) axially drilled and threaded to said proximal section to a threaded position in which said elastic tubular element deforms.
8.- Dispositivo según por lo menos una de las reivindicaciones 1 a 7, caracterizado porque dicha cabeza (8) dispone de unas aletas de fijación (26) para la inmovilización del dispositivo con respecto a dicho paciente. 8. Device according to at least one of claims 1 to 7, characterized in that said head (8) has fixing fins (26) for immobilization of the device with respect to said patient.
PCT/ES1999/000241 1998-07-30 1999-07-29 Device for introducing catheters into a blood vessel of a patient WO2000006241A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ESU9802040 1998-07-30
ES9802040U ES1040985Y (en) 1998-07-30 1998-07-30 DEVICE FOR THE INTRODUCTION OF CATHETERS IN A BLOOD VESSEL OF A PATIENT.

Publications (1)

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WO2000006241A1 true WO2000006241A1 (en) 2000-02-10

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WO (1) WO2000006241A1 (en)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2565491A1 (en) * 1984-06-08 1985-12-13 Monties Jean Raoul Multi-path catheter
US4573470A (en) * 1984-05-30 1986-03-04 Advanced Cardiovascular Systems, Inc. Low-profile steerable intraoperative balloon dilitation catheter
EP0244955A1 (en) * 1986-04-07 1987-11-11 Advanced Cardiovascular Systems, Inc. Multiple angioplasty apparatus
WO1993025252A1 (en) * 1992-06-05 1993-12-23 Thomas Medical Products, Inc. Catheter introducer with lubrication means
WO1995013840A1 (en) * 1993-11-17 1995-05-26 Pressure Products Medical Supplies, Inc. Sliceable hemostatic valve and sheath and method

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4573470A (en) * 1984-05-30 1986-03-04 Advanced Cardiovascular Systems, Inc. Low-profile steerable intraoperative balloon dilitation catheter
FR2565491A1 (en) * 1984-06-08 1985-12-13 Monties Jean Raoul Multi-path catheter
EP0244955A1 (en) * 1986-04-07 1987-11-11 Advanced Cardiovascular Systems, Inc. Multiple angioplasty apparatus
WO1993025252A1 (en) * 1992-06-05 1993-12-23 Thomas Medical Products, Inc. Catheter introducer with lubrication means
WO1995013840A1 (en) * 1993-11-17 1995-05-26 Pressure Products Medical Supplies, Inc. Sliceable hemostatic valve and sheath and method

Also Published As

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ES1040985Y (en) 1999-11-01
ES1040985U (en) 1999-06-01

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