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ES2368404A1 - Percutaneous catheter and method for measuring pressure in blood vessels - Google Patents

Percutaneous catheter and method for measuring pressure in blood vessels Download PDF

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Publication number
ES2368404A1
ES2368404A1 ES200803416A ES200803416A ES2368404A1 ES 2368404 A1 ES2368404 A1 ES 2368404A1 ES 200803416 A ES200803416 A ES 200803416A ES 200803416 A ES200803416 A ES 200803416A ES 2368404 A1 ES2368404 A1 ES 2368404A1
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Prior art keywords
pressure
catheter
blood
blood vessel
measure
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Granted
Application number
ES200803416A
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ES2368404B1 (en
Inventor
Jaime Bosch Genover
Andrea De Gottardi
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BIOMEDICA HOSPITAL CLINIC I PROVINCIAL
Universitat de Barcelona UB
Fundacio Clinic per a la Recerca Biomedica FCRB
Hospital Clinic de Barcelona
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BIOMEDICA HOSPITAL CLINIC I PROVINCIAL
Universitat de Barcelona UB
Fundacio Clinic per a la Recerca Biomedica FCRB
Hospital Clinic de Barcelona
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Priority to ES200803416A priority Critical patent/ES2368404B1/en
Priority to PCT/EP2009/066056 priority patent/WO2010063676A1/en
Publication of ES2368404A1 publication Critical patent/ES2368404A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021Measuring pressure in heart or blood vessels
    • A61B5/0215Measuring pressure in heart or blood vessels by means inserted into the body
    • A61B5/02152Measuring pressure in heart or blood vessels by means inserted into the body specially adapted for venous pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852Catheters
    • A61B5/6853Catheters with a balloon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0017Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/0208Subcutaneous access sites for injecting or removing fluids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M2025/0001Catheters; Hollow probes for pressure measurement
    • A61M2025/0003Catheters; Hollow probes for pressure measurement having an additional lumen transmitting fluid pressure to the outside for measurement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1052Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/0208Subcutaneous access sites for injecting or removing fluids
    • A61M2039/0211Subcutaneous access sites for injecting or removing fluids with multiple chambers in a single site
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2230/00Measuring parameters of the user
    • A61M2230/30Blood pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M25/0032Multi-lumen catheters with stationary elements characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Physics & Mathematics (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Pathology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Physiology (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Epidemiology (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Catéter percutáneo y método para medir presión en vasos sanguíneos, que permite una medición continua del gradiente de presión en la vena hepática, que comprende un catéter de presión (1), configurado para medir y registrar presión en un vaso sanguíneo (2), que comprende un elemento inflable (3) configurado para ocluir dicho vaso sanguíneo (2) cuando está inflado y permitir el flujo libre de sangre por dicho vaso sanguíneo (2) cuando está desinflado, en el que dicho catéter de presión (1) está operativamente conectado a un catéter intravenoso (4) de uso prolongado que comprende una cavidad doble.Percutaneous catheter and pressure measurement method in blood vessels, which allows continuous measurement of the gradient of pressure in the hepatic vein, which comprises a pressure catheter (1), configured to measure and record pressure in a blood vessel (2), comprising an inflatable element (3) configured to occlude said blood vessel (2) when inflated and allow flow free of blood by said blood vessel (2) when deflated, wherein said pressure catheter (1) is operatively connected to a long-term intravenous catheter (4) comprising a double cavity

Description

Catéter percutáneo y método para medir presión en vasos sanguíneos.Percutaneous catheter and pressure measurement method in blood vessels

Objeto de la invenciónObject of the invention

Un primer aspecto de la presente invención se refiere a un catéter percutáneo y un segundo aspecto se refiere a un método para medir presión en vasos sanguíneos, que tienen aplicación en el ámbito de la medicina, y más concretamente en el diagnóstico de enfermedades hepáticas crónicas, permitiendo un acceso de uso prolongado a la vena hepática así como la medición continua y a largo plazo del gradiente de presión venoso hepatoportal, sin necesidad de repetir procedimientos invasivos en el paciente.A first aspect of the present invention is refers to a percutaneous catheter and a second aspect refers to a method to measure pressure in blood vessels, which have application in the field of medicine, and more specifically in the diagnosis of chronic liver diseases, allowing access to use prolonged to the hepatic vein as well as continuous measurement and to long-term hepatoportal venous pressure gradient, without need to repeat invasive procedures in the patient.

Antecedentes de la invenciónBackground of the invention

Existe una serie de características que confieren una gran importancia a la medición de la presión de la vena porta, derivadas de las significativas complicaciones que surgen en los casos de hipertensión portal, en inglés Portal Hypertension (PHT), en los que se produce un incremento anormal de la presión sanguínea en dicha vena porta. Es de destacar que contrariamente a otros vasos sanguíneos, la vena porta es de difícil acceso para la realización de procedimientos diagnósticos, por lo que todos ellos son invasivos y requieren ser realizados en el hospi-
tal.
There are a number of characteristics that give great importance to the measurement of portal vein pressure, derived from the significant complications that arise in cases of portal hypertension, in English Portal Hypertension (PHT) , in which there is an increase abnormal blood pressure in said portal vein. It is noteworthy that contrary to other blood vessels, the portal vein is difficult to access for diagnostic procedures, so all of them are invasive and need to be performed in the hospital.
such.

La hipertensión portal es una complicación muy frecuente en las enfermedades hepáticas crónicas como la cirrosis, siendo la principal causa de mortalidad y de trasplante hepático en estos pacientes.Portal hypertension is a very complicated complication. frequent in chronic liver diseases such as cirrhosis, being the main cause of mortality and liver transplantation in these patients

En tales casos, un incremento sostenido de la presión en la vena porta, tiene como consecuencia la aparición de varices esofágicas y gástricas, las cuales incrementan el riesgo de que se produzcan episodios de desangrado. Habitualmente, dichos episodios de desangrado ocurren en hasta un 35% de los pacientes que tienen cirrosis y varices esofagogástricas. Asimismo, la hipertensión portal determina la aparición de ascitis, trastornos circulatorios y de la función renal, y facilita la aparición de complicaciones graves como la peritonitis bacteriana espontánea y la encefalopatía hepática, entre otras.In such cases, a sustained increase in the pressure in the portal vein, results in the appearance of esophageal and gastric varicose veins, which increase the risk of that bleeding episodes occur. Usually said bleeding events occur in up to 35% of patients who They have cirrhosis and esophagogastric varices. Also, the Portal hypertension determines the appearance of ascites, disorders circulatory and renal function, and facilitates the appearance of serious complications such as spontaneous bacterial peritonitis and hepatic encephalopathy, among others.

La hipertensión portal se desarrolla cuando se produce un incremento de la resistencia al flujo de sangre a través del hígado y un incremento del flujo de entrada en la vena porta.Portal hypertension develops when produces an increase in resistance to blood flow through of the liver and an increase in the inflow into the vein holder.

En la actualidad, la medición de presión en la vena hepática ocluida, en inglés Wedged Hepatic Venous Pressure (WHVP), es el procedimiento diagnóstico más común para la determinación indirecta de la presión portal. Para ello, una de la venas hepáticas es cateterizada percutáneamente bajo control fluoroscópico por vía transyugular (o tras la punción de otra vena periférica, como la femoral o antecubital) mediante la utilización de un catéter que comprende un balón de oclusión, como por ejemplo el descrito en "Berenstein occlusion balloon catheter M001173010, 17-301, Boston Scientific". A continuación el balón es inflado hasta ocluir completamente una rama de la vena hepática, momento en el que se mide y se registra el valor de presión en la vena hepática ocluida (WHVP). Después, se desinfla el balón y se registra la presión en la vena hepática libre, en inglés Free Hepatic Venous Pressure (FHVP). La diferencia entre ambas presiones es el denominado gradiente de presión venosa hepática, en inglés Hepatic Venous Pressure Gradient (HVPG), el cual es un Índice de la presión portal en la cirrosis.Currently, the measurement of pressure in the occluded hepatic vein, in English Wedged Hepatic Venous Pressure (WHVP) , is the most common diagnostic procedure for the indirect determination of portal pressure. For this, one of the hepatic veins is catheterized percutaneously under fluoroscopic control by transjugular route (or after puncture of another peripheral vein, such as the femoral or antecubital) by using a catheter comprising an occlusion balloon, such as the described in " Berenstein occlusion balloon catheter M001173010, 17-301, Boston Scientific ". The balloon is then inflated until a branch of the hepatic vein is completely occluded, at which time the pressure value in the occluded hepatic vein (WHVP) is measured and recorded. Then, the balloon is deflated and the pressure in the free hepatic vein is recorded, in English Free Hepatic Venous Pressure (FHVP) . The difference between both pressures is the so-called hepatic venous pressure gradient, in English Hepatic Venous Pressure Gradient (HVPG) , which is an index of portal pressure in cirrhosis.

En ausencia de hipertensión portal, el gradiente de presión en la vena hepática, esto es el gradiente entre la presión ocluida y libre, es pequeño, (inferior a 5 mmHg), mientras que en presencia de hipertensión portal, dicho gradiente se incrementa. Cuando alcanza valores superiores a 10 mmHg indica el riesgo de aparición de complicaciones de la hipertensión portal (Clinically significant portal hypertension), y cuando éstas están presentes, permite discriminar pacientes que tienen bajo riesgo de sufrir episodios de sangrado, y por lo tanto con menor riesgo de mortalidad, así cómo guiar el tratamiento de la hipertensión
portal.
In the absence of portal hypertension, the pressure gradient in the hepatic vein, this is the gradient between occluded and free pressure, is small (less than 5 mmHg), while in the presence of portal hypertension, said gradient is increased. When it reaches values greater than 10 mmHg, it indicates the risk of complications of portal hypertension ( Clinically significant portal hypertension ), and when these are present, it allows discriminating patients who are at low risk of bleeding episodes, and therefore with less mortality risk, as well as guiding the treatment of hypertension
portal.

Sin embargo, el principal inconveniente que presenta el procedimiento anteriormente expuesto es que la determinación del gradiente de presión en la vena hepática (HVPG) es un procedimiento diagnóstico que frecuentemente tiene que ser realizado varias veces en el mismo paciente, y por lo tanto cada vez que se requiere su ejecución se necesita una infraestructura muy especializada, además del costo y las molestias que supone para el propio paciente el hecho de tener que sufrir procedimientos invasivos periódicos para la medición del HVPG.However, the main drawback that presents the procedure outlined above is that the Determination of the pressure gradient in the hepatic vein (HVPG) is a diagnostic procedure that often has to be performed several times on the same patient, and therefore each time that its execution is required a very infrastructure is needed specialized, in addition to the cost and inconvenience for the own patient the fact of having to undergo procedures Invasive newspapers for the measurement of HVPG.

Descripción de la invenciónDescription of the invention

Un primer aspecto de la presente invención se refiere a un catéter percutáneo para medir presión en vasos sanguíneos, que permite un acceso de uso prolongado a la vena hepática para una medición sencilla y repetida del gradiente de presión en la vena hepática (HVPG), superando la necesidad de repetir procedimientos diagnósticos invasivos en el paciente.A first aspect of the present invention is refers to a percutaneous catheter to measure pressure in vessels blood vessels, which allows prolonged access to the vein liver for a simple and repeated measurement of the gradient of hepatic vein pressure (HVPG), overcoming the need for Repeat invasive diagnostic procedures in the patient.

El catéter que la invención propone permite su utilización por la vía transyugular o por la vía subclavia, para medir presión en cualquier vaso sanguíneo, es decir en cualquier vena y arteria, como puede ser la vena hepática.The catheter that the invention proposes allows its use by the transjugular route or by the subclavian route, to measure pressure in any blood vessel, that is in any vein and artery, such as the hepatic vein.

Pues bien, de acuerdo con la invención el catéter comprende un catéter de presión, configurado para medir y registrar presión en un vaso sanguíneo, y además, dicho catéter comprende cerca de su extremo distal un elemento inflable, a modo de balón o globo, que está configurado para ocluir dicho vaso sanguíneo cuando está inflado e insertado en el vaso sanguíneo, así como para permitir el flujo libre de sangre por dicho vaso sanguíneo cuando está desinflado. Posicionado en la vena hepática permite medir las presión ocluida cuando está hinchado, y la presión libre estando desinflado, y por tanto el gradiente de presión venosa hepático (HVPG).Well, according to the invention the catheter comprises a pressure catheter, configured to measure and record pressure in a blood vessel, and in addition, said catheter comprises an inflatable element near its distal end, as a balloon or balloon, which is configured to occlude said blood vessel when it is inflated and inserted into the blood vessel, as well as to allow the free flow of blood through said blood vessel when It is deflated. Positioned in the hepatic vein allows measuring occluded pressure when swollen, and free pressure being deflated, and therefore the hepatic venous pressure gradient (HVPG).

Adicionalmente, dicho catéter de presión está operativamente conectado a un dispositivo denominado en inglés Port-a-cath, de uso prolongado que comprende una cavidad doble.Additionally, said pressure catheter is operatively connected to a long-term device called Port-a-cath , comprising a double cavity.

El sistema Port-a-cath comprende un catéter conectado a un sistema de acceso venoso denominado en inglés Totally Implantable Venous Access System. Este sistema consiste en un pequeño dispositivo médico que es instalado bajo la piel permite conectarse a una vena. El dispositivo tiene unas membranas, que comúnmente se denominan como septum, a través de los cuales se inyecta la medicación o se extraen muestras de sangre, tantas veces como sea necesario y con mucha menos molestia para un paciente, en comparación con los medios hasta ahora utilizados, consistentes la cateterización repetida de la vena yugular o femoral. Los catéteres Port-a-cath se utilizan principalmente en tratamientos hematológicos y en pacientes de oncología.The Port-a-cath system comprises a catheter connected to a venous access system called in English Totally Implantable Venous Access System . This system consists of a small medical device that is installed under the skin to connect to a vein. The device has membranes, which are commonly referred to as septum , through which the medication is injected or blood samples are taken, as many times as necessary and with much less discomfort for a patient, compared to the means so far used, consistent repeated catheterization of the jugular or femoral vein. Port-a-cath catheters are mainly used in hematological treatments and in oncology patients.

Un Port-a-cath comprende un reservorio o compartimento de depósito, también denominado "port", que está encapsulado en silicona para permitir la inserción de una aguja, justamente en el septum. Preferentemente el septum está hecho de una silicona autosellante especial permitiendo ser pinchado por una aguja hasta miles de veces antes de tener que ser sustituido.A Port-a-cath comprises a reservoir or reservoir compartment, also called "port", which is encapsulated in silicone to allow the insertion of a needle, just into the septum. Preferably the septum is made of a special self-sealing silicone allowing it to be punctured by a needle up to thousands of times before having to be replaced.

Para su colocación en un paciente se requiere una pequeña intervención quirúrgica. En la misma se coloca el Port-a-cath debajo de la piel, y el catéter a él conectado se introduce a través de la vena yugular o subclavia hasta alcanzar la vena hepática.A small surgical intervention is required for placement in a patient. In it the Port-a-cath is placed under the skin, and the catheter connected to it is inserted through the jugular or subclavian vein until it reaches the hepatic vein.

La invención permite por tanto acceder a la vena hepática y medir el gradiente de presión hepatoportal venoso, es decir medir la diferencia de presión en la vena hepática ocluida y libre, a largo plazo y de manera continua.The invention therefore allows access to the vein liver and measure the venous hepatoportal pressure gradient, it is say measure the pressure difference in the occluded hepatic vein and free, long term and continuously.

El catéter de la invención integra una doble luz (lumen), una para medir la presión en el interior de la vena en que está colocado, la otra para permitir hinchar un balón en su extremo (balón de oclusión) para medir la presión en la vena hepática libre y oclui-
da.
The catheter of the invention integrates a double light (lumen), one to measure the pressure inside the vein in which it is placed, the other to allow a balloon to swell at its end (occlusion balloon) to measure the pressure in the free and occluded hepatic vein
gives.

Se contempla la posibilidad de que el catéter esté configurado para acceder a la vena hepática y medir, así como registrar, presión en la vena hepática y detectar hipertensión portal mediante la diferencia entre un valor de presión en la vena hepática ocluida y un valor de presión en la vena hepática libre.The possibility that the catheter is contemplated be configured to access the hepatic vein and measure, as well as record, pressure in the hepatic vein and detect hypertension portal through the difference between a pressure value in the vein hepatic occluded and a pressure value in the hepatic vein free.

Se contempla la posibilidad de que el catéter percutáneo para medir presión en vasos sanguíneos comprenda medios de monitorización continua de la presión medida en dicho vaso sanguíneo.The possibility that the catheter is contemplated percutaneous to measure blood vessel pressure understand means for continuous monitoring of the pressure measured in said vessel blood

Un segundo aspecto de la presente invención se refiere a un método diagnóstico para medir presión en vasos sanguíneos, que comprende utilizar un catéter percutáneo como el anteriormente definido, sin la necesidad de realizar procedimientos invasivos repetitivos en el paciente.A second aspect of the present invention is refers to a diagnostic method to measure pressure in vessels blood, which includes using a percutaneous catheter such as previously defined, without the need to perform procedures Invasive repetitive in the patient.

Para el propósito de la invención, el catéter puede ser insertado vía transyugular.For the purpose of the invention, the catheter It can be inserted transjugularly.

El método esté configurado para determinar casos clínicos de hipertensión portal mediante la medición continua y/o repetida de la presión en la vena hepática y del HVPG, comprendiendo las siguientes etapas:The method is configured to determine cases Clinical portal hypertension through continuous measurement and / or repeated pressure in the hepatic vein and HVPG, comprising the following stages:

- implantar un catéter intravenoso en la vena hepática, y un sistema subcutáneo para uso prolongado de vía venosa,- implant an intravenous catheter into the vein liver, and a subcutaneous system for prolonged use of the pathway venous,

- conectar dicho catéter intravenoso a un catéter de presión,- connect said intravenous catheter to a pressure catheter,

- ocluir la vena hepática mediante inflado de un elemento inflable y medir, así como registrar, presión, y- occlude the hepatic vein by inflating a inflatable element and measure, as well as record, pressure, and

- desinflar el elemento inflable y medir presión.- deflate the inflatable element and measure Pressure.

Asimismo, se contempla que el catéter comprenda medios de monitorización continua de la presión medida en la vena hepática, comprendiendo monitorizar de manera continua dicha presión, sin la necesidad de realizar sucesivos procedimientos invasivos.It is also contemplated that the catheter comprises means for continuous monitoring of the pressure measured in the vein hepatic, comprising continuously monitoring said pressure, without the need to perform successive procedures invasive

Descripción de los dibujosDescription of the drawings

Para complementar la descripción que se está realizando y con objeto de ayudar a una mejor comprensión de las características del invento, de acuerdo con un ejemplo preferente de realización práctica del mismo, se acompaña como parte integrante de dicha descripción, un juego de dibujos en donde con carácter ilustrativo y no limitativo, se ha representado lo siguiente:To complement the description that is being performing and in order to help a better understanding of the characteristics of the invention, according to a preferred example of practical realization of it, is accompanied as an integral part of said description, a set of drawings where with character Illustrative and not limiting, the following has been represented:

La figura 1.- Muestra una vista esquemática del catéter percutáneo que la invención propone ubicado en una vena hepática.Figure 1.- Shows a schematic view of the percutaneous catheter that the invention proposes located in a vein Hepatic

La figura 2.- Muestra un detalle del elemento inflable que comprende el catéter de presión, habiéndose representado en la posición de inflado.Figure 2.- Shows a detail of the element inflatable comprising the pressure catheter, having represented in the inflation position.

La figura 3.- Muestra una vista esquemática en perspectiva del catéter de la invención en el que se ha efectuado un corte transversal, para una mejor apreciación de la doble cavidad interior.Figure 3.- Shows a schematic view in perspective of the catheter of the invention in which a cross section, for a better appreciation of the double cavity inside.

Realización preferente de la invenciónPreferred Embodiment of the Invention

A la vista de las figuras reseñadas puede observarse como en una de las posibles realizaciones de la invención el catéter percutáneo para medir presión en vasos sanguíneos que la invención propone comprende un catéter de presión (1), configurado para medir y registrar presión en un vaso sanguíneo (2), donde dicho catéter de presión (1) comprende un elemento inflable (3) que está configurado para ocluir dicho vaso sanguíneo (2) cuando está inflado e insertado en el vaso sanguíneo (2), así como para permitir el flujo libre de sangre por dicho vaso sanguíneo (2) cuando está desinflado.In view of the figures outlined you can be observed as in one of the possible embodiments of the invention the percutaneous catheter to measure pressure in blood vessels that the invention proposes comprises a pressure catheter (1), configured to measure and record pressure in a blood vessel (2), where said pressure catheter (1) comprises an inflatable element (3) that is configured to occlude said blood vessel (2) when it is inflated and inserted into the blood vessel (2), as well as to allow the free flow of blood through said blood vessel (2) when it is deflated.

Adicionalmente, el catéter de presión (1) está operativamente conectado a un catéter intravenoso (4) de uso prolongado que comprende una cavidad doble.Additionally, the pressure catheter (1) is operatively connected to an intravenous catheter (4) for use prolonged comprising a double cavity.

La invención permite acceder a la vena hepática y medir el gradiente de presión hepatoportal venoso, es decir medir la diferencia de presión en la vena hepática ocluida y libre, a largo plazo y de manera continua.The invention allows access to the hepatic vein and measure the hepatoportal venous pressure gradient, that is, measure the pressure difference in the occluded and free hepatic vein, at Long term and continuously.

El catéter de la invención integra un dual lumen Port-a-cath con un catéter de presión (1), esto es un catéter tipo Berenstein con balón de oclusión para medir la presión en la vena hepática libre y ocluida.The catheter of the invention integrates a dual Port-a-cath lumen with a pressure catheter (1), this is a Berenstein type catheter with occlusion balloon to measure the pressure in the free and occluded hepatic vein.

De acuerdo con una realización preferente de la invención, el catéter percutáneo comprende medios de monitorización continua o repetida de la presión medida en dicho vaso sanguíneo.According to a preferred embodiment of the invention, the percutaneous catheter comprises monitoring means continuous or repeated pressure measured in said vessel blood

Asimismo, el catéter está configurado para acceder a la vena hepática y medir, así como registrar, presión en la vena hepática y detectar hipertensión portal mediante la diferencia entre un valor de presión en la vena hepática ocluida y un valor de presión en la vena hepática libre.Also, the catheter is configured to access the hepatic vein and measure, as well as record, pressure in the hepatic vein and detect portal hypertension through the difference between a pressure value in the occluded hepatic vein and a pressure value in the free hepatic vein.

A la vista de esta descripción y juego de figuras, el experto en la materia podrá entender que las realizaciones de la invención que se han descrito pueden ser combinadas de múltiples maneras dentro del objeto de la invención. La invención ha sido descrita según algunas realizaciones preferentes de la misma, pero para el experto en la materia resultará evidente que múltiples variaciones pueden ser introducidas en dichas realizaciones preferentes sin exceder el objeto de la invención reivindicada.In view of this description and game of figures, the expert in the field may understand that the Embodiments of the invention that have been described may be combined in multiple ways within the object of the invention. The invention has been described according to some embodiments. Preferred, but for the person skilled in the art it will be clear that multiple variations can be introduced in said preferred embodiments without exceeding the purpose of the claimed invention.

Claims (3)

1. Catéter percutáneo para medir presión en vasos sanguíneos, que comprende un catéter de presión (1), configurado para medir y registrar presión en un vaso sanguíneo (2), que comprende un elemento inflable (3) configurado para ocluir dicho vaso sanguíneo (2) cuando está inflado y permitir el flujo libre de sangre por dicho vaso sanguíneo (2) cuando está desinflado, caracterizado porque dicho catéter de presión (1) está operativamente conectado a un catéter intravenoso (4) de uso prolongado que comprende una cavidad o reservorio doble a la que se accede por punción, de las que una está conectada a la luz del catéter que permite hinchar y deshinchar el balón de oclusión y la otra a la luz que permite medir la presión u obtener muestras sanguíneas.1. Percutaneous catheter for measuring pressure in blood vessels, comprising a pressure catheter (1), configured to measure and record pressure in a blood vessel (2), comprising an inflatable element (3) configured to occlude said blood vessel ( 2) when inflated and allow the free flow of blood through said blood vessel (2) when deflated, characterized in that said pressure catheter (1) is operatively connected to a prolonged use intravenous catheter (4) comprising a cavity or double reservoir that is accessed by puncture, of which one is connected to the catheter light that allows the occlusion balloon to swell and deflate and the other to the light that allows to measure the pressure or obtain blood samples. 2. Catéter percutáneo para medir presión en vasos sanguíneos, según la reivindicación 1, caracterizado porque comprende medios de monitorización continua de la presión medida en dicho vaso sanguíneo (2).2. Percutaneous catheter for measuring pressure in blood vessels according to claim 1, characterized in that it comprises means for continuous monitoring of the pressure measured in said blood vessel (2). 3. Catéter percutáneo para medir presión en vasos sanguíneos, según cualquiera de las reivindicaciones 1 y 2, caracterizado porque puede medir la diferencia entre un valor de presión en la vena hepática ocluida y un valor de presión en la vena hepática libre.3. Percutaneous catheter for measuring blood vessel pressure according to any of claims 1 and 2, characterized in that it can measure the difference between a pressure value in the occluded hepatic vein and a pressure value in the free hepatic vein.
ES200803416A 2008-12-01 2008-12-01 PERCUTANEOUS CATHETER AND METHOD FOR MEASURING PRESSURE IN BLOOD VESSELS. Expired - Fee Related ES2368404B1 (en)

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PCT/EP2009/066056 WO2010063676A1 (en) 2008-12-01 2009-11-30 Percutaneous catheter and method for measuring pressure in blood vessels

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WO2013012721A2 (en) 2011-07-15 2013-01-24 Vanderbilt University Apparatus and methods for measuring peripheral venous pressure and applications of same
CN105825070A (en) * 2016-04-06 2016-08-03 南方医科大学南方医院 Measurement method of virtual hepatic vein pressure gradient
WO2019103694A1 (en) * 2017-11-24 2019-05-31 National University Hospital (Singapore) Pte Ltd Balloon-anchored biopsy device
CN110270004A (en) * 2019-07-25 2019-09-24 苏州恒瑞宏远医疗科技有限公司 HVPG foley's tube and preparation method thereof

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US4878898A (en) * 1987-08-17 1989-11-07 Nova Medical Specialties Thermodilution and pressure transducer balloon catheter
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