WO2015132435A1 - Cathéter pour le traitement de l'hydrocéphalie - Google Patents

Cathéter pour le traitement de l'hydrocéphalie Download PDF

Info

Publication number
WO2015132435A1
WO2015132435A1 PCT/ES2015/070146 ES2015070146W WO2015132435A1 WO 2015132435 A1 WO2015132435 A1 WO 2015132435A1 ES 2015070146 W ES2015070146 W ES 2015070146W WO 2015132435 A1 WO2015132435 A1 WO 2015132435A1
Authority
WO
WIPO (PCT)
Prior art keywords
holes
ring
rings
catheter
same
Prior art date
Application number
PCT/ES2015/070146
Other languages
English (en)
Spanish (es)
Inventor
Jose Maria AMIGO GARCIA
Angel Gimenez Pastor
Olga Pellicer Porcar
Jose VALERO CUADRA
Marcelo Galarza
Original Assignee
Universidad Miguel Hernandez De Elche
Fundacion Para La Formacion E Investigación Sanitaria En La Region De Murcia
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 Universidad Miguel Hernandez De Elche, Fundacion Para La Formacion E Investigación Sanitaria En La Region De Murcia filed Critical Universidad Miguel Hernandez De Elche
Publication of WO2015132435A1 publication Critical patent/WO2015132435A1/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
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
    • A61M27/006—Cerebrospinal drainage; Accessories therefor, e.g. valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M2025/0073—Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow

Definitions

  • the present invention consists of a catheter of novel design conceived for the treatment of hydrocephalus, where traditionally this type of elements consists of a tubular shaped device arranged so that one of the ends is inserted into one of the ventricular cavities of the brain, of so that through the holes at that end it is possible to evacuate the accumulated cerebrospinal fluid, or to divert it to another part of the body where it is naturally absorbed.
  • This end of the catheter is closed by its base (the "tip” of the catheter) to enable its insertion into the ventricle, and has holes arranged in its lateral wall in rings transverse to the axis of the catheter, called drainage rings or, simply, rings
  • this device is characterized by having a variable number of holes in the drain rings, so that the uniformity of the passage of fluid through the catheter is favored, while minimizing the possibility of hole obstruction and redistribution of the flow is possible in the event that any of said holes become clogged, thus extending the life of the device.
  • the present invention will have application within the medical components industry, more specifically within the field of devices intended for the derivation or evacuation of body fluids from a patient.
  • Hydrocephalus (a term that derives from the Greek words "hydro” meaning water and “head” meaning head) is a disorder whose main characteristic is the excessive accumulation of fluid in the brain, resulting in an abnormal dilation of the spaces in the brain called ventricles, causing potentially damaging pressure on the tissues of the brain. Generally the increase in fluid in the ventricles is caused by the obstruction of the ducts located below the cerebellum. The usual treatment involves the drainage of excess fluid through a cannula or catheter inserted into one of the ventricular cavities of the brain.
  • Said catheter disposes at the end inserted in the ventricle of several orifices through which the liquid penetrates for its extraction, while the opposite end is connected to a valve that regulates the pressure of exit of the liquid and transfers it well to a second catheter that directs the liquid to another part of the body where it can be absorbed or extracted outside, to a drainage bag.
  • a valve that regulates the pressure of exit of the liquid and transfers it well to a second catheter that directs the liquid to another part of the body where it can be absorbed or extracted outside, to a drainage bag.
  • drain rings each of these rings having a constant number of holes, usually 2 (opposite to the axis of the catheter) or 4 (opposite two to two). In most cases, the separation between the drain rings is identical, although there are also designs in which the distances between them vary.
  • Rivulet design An advantage of the Rivulet design is that the suspended elements within the ventricle (macromolecules and tissues) can hardly be introduced through the proximal holes, minimizing the risk of clogging the inner duct of the downstream catheter and, therefore, rendering it useless by full. But that is also its weak point, because according to CA Harris and JP McAllister II (Childs Nerv. Syst. 27 (2011) 1221-1232), the adhesion of the suspended elements to the catheter generally increases as the hole diameter decreases , which favors the obstruction of the proximal holes in the Rivulet design.
  • the catheter proposed herein achieves the same objective as the Rivulet catheter, namely to homogenize the distribution of the flow rates per ring, but without necessarily varying the diameters of the holes.
  • the new design achieves this objective thanks to the variation in the number of holes in the drain rings, said number being greater in the distal rings (the farthest from the valve) and smaller in the proximal rings, optionally also combined with the variation of the size of the holes.
  • This hole configuration also provides important advantages such as maintaining the uniformity of the flow when the drain rings are rotated independently, when holes are clogged randomly, or when the dimensions and / or geometry of the cavity of the cavity are varied. ventricle. In the case that the size of the holes is varied, this design prevents the holes from having to be excessively small and that there are large variations between their sizes.
  • This invention differs from that described in the present application in the fact of presenting a different objective, since its mission is not the drainage of the cerebrospinal fluid, but its derivation towards the area of natural absorption of this within the brain.
  • the composition of the device is very complex compared to that described herein, in addition to the way in which the flow is regulated for the evacuation of the liquid, by means of valves and flow regulators differs completely from the way described herein.
  • This invention therefore does not allow a simple intervention of insertion of the device and evacuation to the outside of the liquid since its high complexity forces its size to be relatively large, making it impossible to have a simple surgical intervention.
  • Fluid bypass system for the treatment of hydrocephalus (CSF Dynamics A / S, 11-09-2001) describes a system composed of a cerebral ventricle catheter and a sinus catheter intended to bridge the obstacle which prevents the circulation of cerebrospinal fluid.
  • the resistance to the flow of the system is set within different intervals, although it is not indicated how these values are achieved. No catheter configuration similar to that described in the present application is described.
  • Variable pressure device with double valve for hydrocephalus (Phoenix Biomedical Corp., 03-05-1994) describes a device that solves the problems of single valve devices, which do not regulate the correct relationship between the volume of fluid drained and the intracranial pressure and can cause hyper drainage due to the siphon effect.
  • Said device consists of a cylinder in which two valves are disposed inside, each with a differentiated function, at whose ends there are two input and output catheters of cerebrospinal fluid. This device differs in the object of the present invention, since it does not imply any improvement over any of the catheters that it incorporates, but is intended for the better control of the exit and entry of the liquid through said elements.
  • Ion beam Sputter-etched ventricular catheter for hydrocephalus shunt (National Aeronautics and space administration, NASA, 01-04-1982) describes a catheter composed of a plurality of microtubes that conduct the cerebrospinal fluid, where each microtubes have of a plurality of holes as well as a larger inlet at the end. It differs from the invention which is recommended in the present application in the fact that it has a highly complex configuration in comparison, requiring for its manufacture a novel process in which bombardment of ion beams on polymer microtubes is used. The invention of the present application is capable of offering similar benefits through a simple and easily manufactured configuration.
  • Device for the treatment of hydrochloride EVERY catheter perfectionné refers to a catheter in which at a predetermined distance its free end is arranged a collar that allows its positioning at the level of the dura, where next to said collar there is a plurality of holes that communicate with the subarachnoid spaces. Said holes are preferably axially elongated. and its rounded edges.
  • This catheter has the usual cerebrospinal fluid entry holes in this type of elements, so that it does not solve in any case the problems that the device of the present application solves.
  • the catheter design that is recommended herein consists of a catheter similar to any of the traditional ones, configured as a thin and flexible hollow tube having at its closed end a series of holes distributed in various drain rings, where the number of holes in each of said rings is not the same in all of them.
  • This general concept has been tested by numerous three-dimensional numerical simulations that allow you to easily compare current catheters with respect to new geometric configurations. These models reproduce in great detail the geometry of the catheters and allow to calculate a whole series of Descriptive parameters of the fluid (speed, pressure, shear stress, flow rate, etc.). As a result of these numerical analyzes, the properties of the designs based on variable hole distributions have been verified.
  • the orifice distribution that characterizes the present invention has the following general characteristics:
  • the distance between rings and the inner and outer diameters of the conical holes may vary depending on the desired flow distribution. For reasons of mechanical strength, the distance between rings must not be less than 0.5 mm. In order to increase the distance between different ring holes, it is recommended that adjacent rings be rotated relative to each other (which does not vary the flow distribution per ring). The number of holes in each ring will vary progressively, being greater in the distal rings (the farthest from the valve) and smaller in the proximal rings. In this way it is possible to standardize the flow through all the drain rings, as well as minimize the impact of possible obstructions in any of the holes.
  • the distance between adjacent drain rings may be the same in all rings, or vary between each one.
  • the angle between two holes of the same ring is defined from the first distal ring (the one closest to the tip of the catheter and with the greatest number of holes), so that it is calculated by dividing the 360 ° of the cross-section of the catheter Enter the number of holes.
  • next ring in case of having the same number of holes, will have the same angular distance between them as in the previous ring, although (half of the angle between holes will be rotated with respect to the previous ring. Although this angular rotation does not affects the distribution of the flow, presents advantages from the point of view of the mechanical resistance of the catheter.
  • the distance between adjacent drain rings may be the same in all rings, or vary between each one.
  • the angle between two holes of the same ring is defined from the first distal ring (the one closest to the tip of the catheter and with the greatest number of holes), so that it is calculated by dividing the 360 ° of the cross-section of the catheter Enter the number of holes.
  • provisions 1 and 2 differ by the existence (provision 1) or not (provision 2) of rotations between adjacent rings. As stated above, these rotations are advisable for reasons of mechanical resistance in designs with very close rings.
  • Fig. 1.- A first configuration of the catheter is represented according to the orifice distribution patterns called "arrangement 1" with constant distance between rings, presenting a perspective view and a longitudinal section that is associated with a series of cross sections. corresponding to each drain ring, where the hole distribution can be easily observed.
  • Fig. 2.- A second configuration of the catheter is represented according to the orifice distribution patterns called "arrangement 1" with variable distances between rings, presenting a perspective view and a longitudinal section that is associated with a series of cross sections. corresponding to each drain ring, where the hole distribution can be easily observed.
  • Example 1 A catheter formed by a hollow tube (1) of 2.5 mm outer diameter and 1.5 mm inner diameter is provided, which will have a total of 18 holes (2) and 4 drain rings (3) .
  • the characteristics of each of the drain rings (3) are described below by a table, where they are designated from 1 to 4, with 1 being the ring closest to the tip (or closed end) of the catheter (4 ):
  • the distribution of holes (2) in the ring 1 will be such that a separation of 60 ° between each of them is arranged, while in the ring 2 they will be arranged with the same angular separation but rotated 30 ° with respect to the ring scheme 1.
  • the same distribution of the ring 1 is presented (that is, the configuration of the ring 2 by applying the 30 ° rotation again), removing two of the holes (2) so that the resulting arrangement presents symmetry with with respect to both axes of symmetry of the cross section of the tube (1).
  • the same configuration of ring 3 will be presented by applying the 30 ° rotation and removing two holes (2) so that symmetry is preserved.
  • Example 2 the same configuration of ring 3 will be presented by applying the 30 ° rotation and removing two holes (2) so that symmetry is preserved.
  • a catheter formed by a hollow tube (1) of 2.5 mm outer diameter and 1.5 mm inner diameter is provided, which will have a total of 24 holes (2) and 6 drain rings (3) , 1 being the ring (3) closest to the tip (or closed end) of the catheter (4).
  • the main feature of this design is that the rings are grouped two by two, forming strips (5).
  • rings 1 and 2 are grouped in a first strip (5), called distal, 1 mm from each other.
  • Rings 3 and 4 are grouped in an intermediate strip (5), 1 mm from each other.
  • rings 5 and 6 are grouped in a third strip (5), called proximal, also 1 mm from each other.
  • the two rings of the distal fringe (5) each have 6 holes, decreasing this number to 4 in the intermediate fringe (5), and 2 in the proximal fringe (5).
  • the characteristics of each of the drain rings (3) are described below in a table.
  • the holes (2) in rings 1 and 2 have an angular separation of 60 ° between them and the rotation between the first ring (3) and the second is 30 °.
  • the holes (2) of rings 3 and 4 have an angular separation of 90 ° between them and the rotation between rings is 45 °.
  • the holes (2) of rings 5 and 6 have an angular separation of 180 ° between them and the rotation between rings is 90 °.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Otolaryngology (AREA)
  • Neurology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • External Artificial Organs (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention concerne une conception de cathéter, lequel cathéter est caractérisé en ce qu'il dispose d'un nombre variable d'orifices (2) dans les différents anneaux de drainage (3), de manière à favoriser l'uniformité du passage du fluide à travers le cathéter (1), tout en minimisant la possibilité d'obstruction d'orifices (2) et en rendant possible la redistribution du flux si un des orifices (2) est obstrué, ce qui augmente la vie utile du dispositif. Il existe deux configurations possibles de répartition d'orifices (2) basées sur des règles décrites pour la distribution d'orifices (2) sur des anneaux (3), qui se différencient de par la séparation entre les anneaux (3), le nombre d'orifices (2) dans chacun des anneaux (3) et la rotation de ceux-ci.
PCT/ES2015/070146 2014-03-06 2015-03-02 Cathéter pour le traitement de l'hydrocéphalie WO2015132435A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ES201400178 2014-03-06
ES201400178A ES2519940B1 (es) 2014-03-06 2014-03-06 Catéter para tratamiento de la hidrocefalia

Publications (1)

Publication Number Publication Date
WO2015132435A1 true WO2015132435A1 (fr) 2015-09-11

Family

ID=51844998

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/ES2015/070146 WO2015132435A1 (fr) 2014-03-06 2015-03-02 Cathéter pour le traitement de l'hydrocéphalie

Country Status (2)

Country Link
ES (1) ES2519940B1 (fr)
WO (1) WO2015132435A1 (fr)

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001034237A1 (fr) * 1999-11-11 2001-05-17 Edwards Lifesciences Corporation Canule de retour veineux a drainage renforce
US6524300B2 (en) * 2000-01-03 2003-02-25 Angiodynamics, Inc. Infusion catheter with non-uniform drug delivery density
US6533763B1 (en) * 1999-12-06 2003-03-18 James A. Schneiter Harmonic flow catheter
US20030216710A1 (en) * 2002-03-26 2003-11-20 Hurt Robert F. Catheter
WO2009132065A1 (fr) * 2008-04-22 2009-10-29 Becton, Dickinson And Company Systèmes et procédés pour améliorer l'efficacité d'un réseau de trous de cathéter
ES2353221T3 (es) * 2004-09-30 2011-02-28 CODMAN & SHURTLEFF, INC. Implantes de gestiã“n de flujo de fluidos de resistencia a oclusiã“n mejorada.
US20110282264A1 (en) * 2002-03-26 2011-11-17 Medtronic Ps Medical, Inc. Method of draining cerebrospinal fluid
WO2013019947A2 (fr) * 2011-08-03 2013-02-07 Venous Therapy, Inc. Ensembles, systèmes et procédés de perfusion d'agents thérapeutiques dans le corps

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001034237A1 (fr) * 1999-11-11 2001-05-17 Edwards Lifesciences Corporation Canule de retour veineux a drainage renforce
US6533763B1 (en) * 1999-12-06 2003-03-18 James A. Schneiter Harmonic flow catheter
US6524300B2 (en) * 2000-01-03 2003-02-25 Angiodynamics, Inc. Infusion catheter with non-uniform drug delivery density
US20030216710A1 (en) * 2002-03-26 2003-11-20 Hurt Robert F. Catheter
US20110282264A1 (en) * 2002-03-26 2011-11-17 Medtronic Ps Medical, Inc. Method of draining cerebrospinal fluid
ES2353221T3 (es) * 2004-09-30 2011-02-28 CODMAN & SHURTLEFF, INC. Implantes de gestiã“n de flujo de fluidos de resistencia a oclusiã“n mejorada.
WO2009132065A1 (fr) * 2008-04-22 2009-10-29 Becton, Dickinson And Company Systèmes et procédés pour améliorer l'efficacité d'un réseau de trous de cathéter
WO2013019947A2 (fr) * 2011-08-03 2013-02-07 Venous Therapy, Inc. Ensembles, systèmes et procédés de perfusion d'agents thérapeutiques dans le corps

Also Published As

Publication number Publication date
ES2519940B1 (es) 2015-10-22
ES2519940A1 (es) 2014-11-07

Similar Documents

Publication Publication Date Title
US9694166B2 (en) Method of draining cerebrospinal fluid
US6913589B2 (en) Multi-catheter insertion device and method
JP3532219B2 (ja) 水頭症の治療装置
ES2743810T3 (es) Sistema de muestreo de sangre para mejorar el éxito de la extracción y reducir la hemólisis
JP2020534957A (ja) 流れ転向特徴を有する末梢静脈内カテーテル
US8852156B2 (en) Device for implanting medical catheters
US20070142817A1 (en) Catheter
US20220039901A1 (en) Neurosurgical apparatus
ES2488820T3 (es) Catéteres intracraneales optimizados para administración de agentes terapéuticos potenciada por convección
US20120078159A1 (en) Multi-lumen ventricular drainage catheter
CN105031749A (zh) 外部体积限制性csf引流系统
US20190136991A1 (en) Method and apparatus for draining
EP3038697A1 (fr) Appareil pour le traitement des cavités corporelles
WO2015132435A1 (fr) Cathéter pour le traitement de l'hydrocéphalie
US9731102B2 (en) Adjustable resistance, gravitationally activated, anti-siphon valve
US20180126120A1 (en) Catheter curvature braces and methods of using same
JP2018518313A5 (fr)
DE102013108373B4 (de) Ventrikelkatheter sowie System und Set mit einem Ventrikelkatheter
Oliveira et al. Updating technology of shunt valves
ES2952142B2 (es) Cateter ventricular de aplicacion en tratamientos de hidrocefalia
JP4370230B2 (ja) 医療用チューブおよびシャントシステム
RU2732346C1 (ru) Гравитационный регулятор потока жидкостей и газов
RU68901U1 (ru) Шунтирующее устройство для лечения гидроцефалии
US9533091B2 (en) System and method of efficacious body cavity washing
CN208259946U (zh) 可调节负压的引流装置

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 15758896

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 15758896

Country of ref document: EP

Kind code of ref document: A1