WO2015132435A1 - Catheter for treating hydrocephalus - Google Patents

Catheter for treating hydrocephalus Download PDF

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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
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WO
WIPO (PCT)
Prior art keywords
holes
ring
rings
catheter
number
Prior art date
Application number
PCT/ES2015/070146
Other languages
Spanish (es)
French (fr)
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
Priority to ES201400178 priority Critical
Priority to ES201400178A priority patent/ES2519940B1/en
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/en

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Classifications

    • 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
    • A61M27/00Drainage appliances for wounds or the like, i.e. wound drains, implanted drains
    • A61M27/002Implant devices for drainage of body fluids from one part of the body to another
    • A61M27/006Cerebrospinal drainage; Accessories therefor, e.g. valves
    • 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
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked

Abstract

The invention relates to a catheter design characterised by having a variable number of openings (2) in the different drainage rings (3), such that the uniformity of the flow of the fluid through the catheter (1) is facilitated, while the possibility of the openings (2) being obstructed is minimised, and the flow can be redistributed should any of the openings (2) become obstructed, thereby lengthening the useful life of the device. The invention also relates to two possible opening (2) distribution configurations based on described patterns for the distribution of openings (2) in rings (3), differing in terms of the distance between rings (3), the number of openings (2) in each of the rings (3), and the rotation of same.

Description

Catheter for treatment of hydrocephalus

OBJECT OF THE INVENTION

The present invention consists in a catheter of novel design intended for the treatment of hydrocephalus, where traditionally such elements comprises a device of tubular form arranged so that one end is inserted into one of the ventricles of the brain, of so that through holes in said end possible evacuate the accumulated or refer to another part of the body where it is naturally absorbed cerebrospinal fluid. This end of the catheter is closed at its base (the "tip" of the catheter) to enable insertion into the ventricle, and has on its side of ordered holes in transverse rings to the catheter shaft, called rings drain or simply wall, rings.

More specifically, this device is characterized by having a variable number of holes in the rings of drainage, so that the uniformity of the fluid flow is promoted through the catheter, while the possibility of blockage of holes is minimized and flow redistribution if any of said holes becomes clogged, thereby extending the life of the device is possible. SCOPE

The present invention will find application in the medical components industry, more specifically in the field of devices for the bypass or removal of body fluids of a patient. BACKGROUND

Hydrocephalus (a term derived from the Greek words "hydro" meaning water and "cephalic" meaning head) is a disorder whose primary characteristic is excessive accumulation of fluid in the brain, taking resulting in an abnormal widening of spaces brain called ventricles, causing potentially harmful pressure on the brain tissues. Generally increasing the fluid in the ventricles is produced by blockage of the ducts located below the cerebellum. The usual treatment involves draining excess liquid through a heat wave or inserted into one of the ventricles of the brain catheter. The catheter has the end inserted into the ventricle of several holes through which penetrates the liquid for removal, while the opposite end to a valve which regulates the pressure of liquid outlet is connected and transferred either to a second catheter directed the fluid to another part of the body where it can be absorbed or extracts it outside into a drainage bag. Currently there are various types of catheters for performing said drain.

The most common designs have 6 or 8 rings drain, providing each of these rings a constant number of holes, usually 2 (opposite with respect to the catheter axis) or 4 (two to two opposite). In most cases, the separation between the rings drain is identical, although designs where the distances between them vary exist as well.

studies have been published (J. Neurosurg. 99 (2003), 426-431 J. Lin et al.) where after analyzing numerical and experimentally these catheters, it was found that over 80% of the mass of the cerebrospinal fluid flowing through the two rings closest to the valve ( "proximal rings") drainage. The numerical study was based on a two-dimensional model, and based on this it shows that gradually varying the diameter of the holes (smaller in the proximal rings), is achieved smooth the flow, ie the flow through the different rings is like. Following this first study the type of catheter known rivulet, which was patented based on the results of this study arose. An advantage of the design rivulet is that elements in suspension within the ventricle (macromolecules and tissues) can hardly be introduced through the proximal holes, minimizing the risk of obstructing the inner conduit of the catheter downstream, and therefore it unusable by full. But that is also its weakness, because according CA Harris and JP McAllister II (Childs Nerv. Syst. 27 (2011) 1221- 1232), the adhesion of the suspenders catheter generally increases as orifice diameter decreases , which favors the obstruction of the proximal holes in the Rivulet design.

Therefore, the appearance of a catheter design that allows uniform flow through the rings of drainage but, at the same time minimize the risk of clogging of the holes, so that the lifetime is lengthened is desirable device.

The proposed herein achieves the same objective catheter the catheter rivulet, namely homogenize the distribution of flow per ring, but not necessarily vary the diameters of the holes. Indeed, the new design achieves this objective by varying the number of holes in the rings drain, said greater number in the optionally combined (the farthest valve) and lower in the proximal rings, distal rings also with varying the size of the holes. This hole configuration also provides significant advantages such as the fact preserve flow uniformity where independently rotating rings drain when holes randomly clogged, or when the dimensions and / or geometry of the cavity is varied ventricle. In the case that the size of the holes is varied, this design prevents the holes have to be too small, with large variations between their sizes.

It is known by the holder of the invention the existence of several documents relating to catheter models that have some relevance to the invention disclosed in this application, such as: - The patent with publication number ES 2158548, treatment device hydrocephalus (Sinu shunt, a / S, 18.09.1996) relates to a shunt system to derive CSF cerebrospinal fluid from the cerebral ventricles to the sagittal sinus. Is broadly articulated in a device composed of antechamber flow regulator and valve connected in series which allows to derive the cerebrospinal fluid from the ventricles to the sagittal sinus, bypassing the pathological obstruction causing hydrocephalus and allowing derive said liquid into place normal resorption, regulating the flow of liquid to be within the normal range and avoiding complications due to hyperdrainage. This invention differs from that described in this application in fact have a different purpose, and its mission is not the cerebrospinal fluid drainage, but its derivation to the area of ​​natural absorption of it into the brain. Thus, the composition of the device is very complex compared to the described herein, in addition to how to regulate the flow for evacuation of liquid through valves and flow regulators differs completely from the shape described herein. This invention can not therefore a simple operation device insertion and removal to the outside of the fluid because its high complexity requires that its size is relatively large, disabling a simple surgery.

- Patent ES 2309089, fluid bypass system for the treatment of hydrocephalus (CSF Dynamics A / S, 09.11.2001) describes a system comprising a brain ventricle catheter and sinus catheter intended to bypass the obstacle preventing the circulation of cerebrospinal fluid. resistance flow passage system within different intervals are fixed, although not indicated how it is achieved achieve these values. any configuration similar to that described in the present application is disclosed catheter.

- Patent ES 2126107, variable pressure device with double hydrocephalus valve (Phoenix Biomedical Corp., 03/05/1994) describes a device which solves the problems of devices single valve, which does not regulate the correct relationship between the volume liquid drained and intracranial pressure and overdrainage can occur due to a siphon effect. Said device consists of a cylinder inside which two valves, each with a distinct function, whose ends respective inlet and outlet catheters cerebrospinal fluid are arranged are arranged. This device differs in the object of the present invention, since not imply any improvement over any of the catheters incorporating, but is intended to better control input and output of the liquid through those elements. - EP 0066685, Ion beam sputter-etched ventricular catheter for hydrocephalus shunt (National Aeronautics and Space Administration, NASA, 01-04- 1982) describes a catheter consisting of a plurality of microtubes cerebrospinal fluid lead, where each has microtubes a plurality of holes and a larger input at the end. It differs from the invention which is proposed in this application in fact have a highly complex shape compared, need for a novel manufacturing process wherein bombardment ion beam on microtubes polymer is used. The invention of the present application is able to provide similar benefits by simple and easy to manufacture configuration.

- Document US 4432853, Method of making an ion beam sputter-etched ventricular catheter for hydrocephalus shunt (Bruce A. Banks, 11.24.1982) discloses an improved composite manufacturing microtube as the previous paragraph catheter method, which likewise has large differences from the invention of the present application.

- FR 2539298 patent Dispositif pour le traitemente perfectionné d'hydrocépahlie avec catheter (Universite Rene Descartes, 01.14.1983) relates to a catheter in which a predetermined distance is its free end a collar that allows its available positioning at the level of the dura where said collar with a plurality of holes communicating with the subarachnoid spaces available. Said holes are preferably axially elongated and rounded edges. This catheter, however, has the inlet of normal cerebrospinal fluid in such elements, so that in any case does not solve the problems that the device of the present application solves.

- Document ES 2309462, hydrocephalus shunt system with endoscopic placement elements (Codman & Shurtleff, Inc., 26-03-2004) discloses a system for deriving CSF which provides, inter alia, a catheter with one end for capturing the liquid and another end that is connected to an extraction device and the liquid bypass. The catheter has fluid inlet holes with the usual configuration of such elements, so as in the invention of the above paragraph, the above problems are not solved.

Therefore, in the prior art known holders herein, it may be noted that no catheter design that this is not known similar characteristics that presents the model that is foreseen, being therefore evident novelty of the present invention and so the protection offered for these types of inventions requested.

DETAILED DESCRIPTION OF THE INVENTION.

The catheter design which is proposed herein is similar to any of the traditional catheter, configured as a thin flexible hollow tube has at its closed a series of holes at multiple rings drain end where number of existing holes in each of said rings is not the same in all. This general concept has been tested by numerous three-dimensional numerical simulations that allow easily compare current catheters regarding new geometric configurations. These models reproduce in great detail the geometry of the catheters and to calculate a number of descriptive parameters of the fluid (velocity, pressure, shear, flow, etc.). The result of these numerical analysis has been found properties based designs varying distributions of holes. The distribution of holes that characterizes the present invention has the following general characteristics:

- it consists of conical holes (ie, the walls are conical surfaces truncated), distributed in a series of rings of drainage along a length less than 30 mm from the catheter tip. For reasons of mechanical strength, the number of holes per ring should not exceed 6.

- The distance between rings and the inner and outer diameters of the tapered holes may vary depending on the desired flow distribution. For reasons of mechanical strength, the distance between rings should not be less than 0.5 mm. To increase the distance between holes in different rings, it is advisable that adjacent rings are rotated relative to each other (which does not change the distribution of flow per ring). The number of holes in each ring will vary progressively, being longer (the farthest valve) and smaller rings in the proximal distal rings. Thus it is achieved smooth the flow through all rings of drainage and minimize the impact of any obstructions in the holes.

Following the guidelines to follow to configure the distribution of holes in the rings are described:

Additional file 1:

- The distance between adjacent rings drain may be equal in all rings or vary between each. - The angle between two holes of the same ring is defined from the first (closest to the catheter tip and greater number of holes) distal ring so calculated by dividing the 360 ​​° of the cross section of the catheter the number of holes.

- The next ring, should have the same number of holes will have the same angular distance between these than the previous ring, while (be rotated half the angle between holes from the previous ring Although this angular rotation not. it affects the flow distribution, has advantages from the standpoint of the mechanical strength of the catheter.

- If a ring see reduced the number of holes from the previous, the same arrangement of holes of the previous ring is maintained, the rotation indicated as it is a new ring, and then the holes would be removed until the desired number and maintaining symmetry with respect to the axes of the cross section of the catheter, so that the angle between holes would not necessarily uniform (if it would reduce the number of holes 2).

Configuration 2:

- The distance between adjacent rings drain may be equal in all rings or vary between each.

- The angle between two holes of the same ring is defined from the first (closest to the catheter tip and greater number of holes) distal ring so calculated by dividing the 360 ​​° of the cross section of the catheter the number of holes.

- The next ring, should have the same number of holes, have identical distribution.

- In case of reducing the number of holes of a ring relative to the above, the same cast will remain subsequently removing the orifices and maintaining the symmetry at least with respect to one axis of symmetry of the cross section of the catheter.

In summary, then, the requirements 1 and 2 are distinguished by the existence (arrangement 1) or not (Configuration 2) of rotation between adjacent rings. As mentioned above, these rotations are desirable for reasons of mechanical strength designs with very close rings.

BRIEF DESCRIPTION OF THE FIGURES

To complement the description being made and in order to facilitate a better understanding of the features of the invention herein as an integral part thereof, is attached drawings made with illustrative and non limitative, which then we proceed to describe:

Fig. 1. a first configuration of the catheter according to the distribution patterns of holes referred to as "layout 1" with constant distance between rings, showing a perspective view and a longitudinal section is associated with a number of cross sections Depicted for each drainage ring, where the distribution of holes can be easily observed.

Fig. 2. a second embodiment of the catheter according to the distribution patterns of holes referred to as "layout 1" with varying distances between rings, showing a perspective view and a longitudinal section is associated with a number of cross sections Depicted for each drainage ring, where the distribution of holes can be easily observed. Description of embodiments

The present invention is illustrated by the following examples, not claiming its representation limit its scope in any way, either partially or completely:

Example 1. A catheter formed by a hollow tube (1) outside diameter and 2.5 mm inner diameter 1.5 mm, which have a total of 18 holes (2) and 4-ring drain (3) are available . Below are described by a table the characteristics of each of the rings drain (3), wherein which are designated 1 through 4, with 1 being the closest ring to the tip (or closed end) of the catheter (4 ):

Figure imgf000012_0001

The distribution of holes (2) on the ring 1 is such that a separation of 60 ° between each of them while ring 2 will be arranged with the same angular separation but rotated 30 ° to the scheme ring available 1. in the ring 3, the same distribution ring 1 is presented (ie, the ring configuration 2 using the 30 ° swivel again), eliminating two of the holes (2) so that the resulting arrangement this symmetry respect to both axes of symmetry of the cross section of the tube (1). Finally, the ring 4 will present the same configuration of the ring 3 using rotation of 30 ° and eliminating two holes (2) so that the symmetry is maintained. Example 2. A catheter formed by a hollow tube (1) outside diameter and 2.5 mm inner diameter 1.5 mm, which have a total of 24 holes (2) and drain 6 rings (3) are available , with 1 being the ring (3) nearest to the tip (or closed end) of the catheter (4). The main feature of this design is that the rings are grouped in pairs, forming strips (5). Thus, the rings 1 and 2 are grouped into a first strip (5), called distal, 1 mm apart. The rings 3 and 4 are grouped in a strip (5) intermediate, 1 mm apart. Finally, the rings 5 ​​and 6 are grouped into a third strip (5), called proximal, likewise 1 mm from each other. The two rings of the strip (5) have distal openings 6 each, reducing the number 4 in the strip (5) intermediate, and 2 in the proximal strip (5). Below are described by a table the characteristics of each of the drain ring (3).

Figure imgf000013_0001

The holes (2) in the rings 1 and 2 have an angular spacing of 60 ° between them and the rotation between the first ring (3) and the second is 30 °. The holes (2) of the rings 3 and 4 have an angular spacing of 90 ° between them and the rotation between rings is 45 °. The holes (2) of the rings 5 ​​and 6 have an angular separation of 180 ° between them and the rotation between rings is 90 °.

sufficiently Described the nature of the present invention, as well as how to implement it, it is not considered necessary to make wider explanation for any expert in the matter to understand its scope and the advantages derived therefrom, stating that, within its essentiality, it may be put into practice in other embodiments differing in detail from that indicated by way of example, and which will also achieve the protection sought provided that no alteration, change or modify its fundamental principle .

Claims

What is claimed
1. Catheter for treatment of hydrocephalus, configured from a hollow tube (1) and closed by a tip (4), in which a series of holes (2) distributed in transverse rings (3) I have laterally, characterized that the number of holes (2) present in each of the rings (3) varies from one ring to another, where the number of holes in each ring will vary progressively, being greater in the rings (3) distal (the near the tip (4)) and lower in the rings (3) proximal (farthest to the tip).
2. CATHETER FOR TREATMENT HYDROCEPHALUS according to claim 1, characterized in that the distribution orifice (2) follow the following guidelines:
- The distance between rings (3) adjacent drainage may be equal in all rings or vary between each.
- The angle between two holes (2) of the same ring (3) is defined from the first (closest to the catheter tip (4) with a larger number of holes (2)) ring (3) distal, so that is calculated by dividing the 360 ​​° of the cross section of the catheter between the number of holes (2).
- The next ring (3), should have the same number of holes (2) have the same angular distance between them in the previous ring (3), but are rotated half the angle between holes (2) relative to the ring (3) above.
- If a ring (3) see reduced the number of holes from the previous, the same arrangement of holes of the ring (3), with rotation indicated for a new ring (3) is held and then suppress the holes (2) until the desired number and maintaining symmetry with respect to the symmetry axes of the cross section of the catheter.
3. CATHETER FOR TREATMENT HYDROCEPHALUS according to claim 1, characterized in that the distribution orifice (2) follow the following guidelines:
- The distance between drain rings (3) adjacent may be equal in all rings or vary between each.
The angle between two holes of the same ring (3) is defined from the first (closest to the catheter tip (4) with a larger number of holes (2)) ring (3) distal, so that calculated by dividing the 360 ​​° of the cross section of the catheter between the number of holes.
The next ring (3), should have the same number of holes, have identical distribution.
If reducing the number of holes of a ring (3) with respect to the above, the same cast will remain subsequently removing the holes (2) and maintaining the symmetry at least with respect to one axis of symmetry of the cross section of the catheter.
4. CATHETER FOR TREATMENT HYDROCEPHALUS according to claims 1 and 2, characterized in that it has 18 holes over four rings, with the following characteristics:
Ring 1 Ring 2 Ring 3 Ring 4
No. holes 6 6 4 2
Distance
4.5 9.0 13.5 18.0 tip (4) (mm)
Radio int / ext
0.25 / 0.20 / 0.25 / hole (2) 0.20 / 0.50
0.50 0.50 0.50 (mm) CATHETER FOR TREATMENT HYDROCEPHALUS according to claims 1 and 3, characterized in that has 24 holes distributed in three strips (5) two rings (3) each, with following characteristics:
Gaza strip
distal strip
proximal intermediate
No. holes 2x6 2x4 2x2
Distance
rings to 4.5 / 6.5 12.0 / 14.0 19.5 / 21.5 tip (4) (mm)
int./ext Radio.
holes (2) 0.25 / 0.50 0.20 / 0.50 0.25 / 0.50 (mm)
PCT/ES2015/070146 2014-03-06 2015-03-02 Catheter for treating hydrocephalus WO2015132435A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
ES201400178 2014-03-06
ES201400178A ES2519940B1 (en) 2014-03-06 2014-03-06 Catheter for treatment of hydrocephalus

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001034237A1 (en) * 1999-11-11 2001-05-17 Edwards Lifesciences Corporation Venous return cannula with enhanced drainage
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 (en) * 2008-04-22 2009-10-29 Becton, Dickinson And Company Systems and methods for improving catheter hole array efficiency
ES2353221T3 (en) * 2004-09-30 2011-02-28 CODMAN & SHURTLEFF, INC. Gestia implants "n fluid flow resistance oclusiã" improved n.
US20110282264A1 (en) * 2002-03-26 2011-11-17 Medtronic Ps Medical, Inc. Method of draining cerebrospinal fluid
WO2013019947A2 (en) * 2011-08-03 2013-02-07 Venous Therapy, Inc. Assemblies, systems, and methods for infusing therapeutic agents into the body

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001034237A1 (en) * 1999-11-11 2001-05-17 Edwards Lifesciences Corporation Venous return cannula with enhanced drainage
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 (en) * 2004-09-30 2011-02-28 CODMAN & SHURTLEFF, INC. Gestia implants "n fluid flow resistance oclusiã" improved n.
WO2009132065A1 (en) * 2008-04-22 2009-10-29 Becton, Dickinson And Company Systems and methods for improving catheter hole array efficiency
WO2013019947A2 (en) * 2011-08-03 2013-02-07 Venous Therapy, Inc. Assemblies, systems, and methods for infusing therapeutic agents into the body

Also Published As

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

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