WO1995008310A1 - Implantable device for the treatment of ×demas - Google Patents

Implantable device for the treatment of ×demas Download PDF

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Publication number
WO1995008310A1
WO1995008310A1 PCT/IB1994/000284 IB9400284W WO9508310A1 WO 1995008310 A1 WO1995008310 A1 WO 1995008310A1 IB 9400284 W IB9400284 W IB 9400284W WO 9508310 A1 WO9508310 A1 WO 9508310A1
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WO
WIPO (PCT)
Prior art keywords
tube
characterized
device according
intended
implanted
Prior art date
Application number
PCT/IB1994/000284
Other languages
French (fr)
Inventor
François PITHON
Original Assignee
Voir Et Vivre E U R L
Pithon Francois
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 FR9311476A priority Critical patent/FR2710269A1/en
Priority to FR93/11476 priority
Application filed by Voir Et Vivre E U R L, Pithon Francois filed Critical Voir Et Vivre E U R L
Publication of WO1995008310A1 publication Critical patent/WO1995008310A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery
    • A61F9/00781Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment

Abstract

Device (1) implantable in any human or animal living organism, intended to evacuate any liquid from an ÷dematic collection, comprising at least one draining tube (6) of which one upstream extremity (6a) is intended to be implanted in the serous cavity in overpressure conditions, and of which another downstream extremity (6b) is intended to be implanted in the evacuation zone, said tube presenting at least partly a sufficient flexibility so that it can be adapted to the shape of the part wherein it is implanted, and being made of at least one biocompatible material, characterized in that the tube presents on the major part of its length between its upstream extremity (6a) and its downstream extremity (6b), and particularly in the portion intended to be associated with the evacuation zone, a lateral permeability providing for a diffusion of substantially all the liquid taken through its upstream extremity (6a), from the inside to the outside and through the wall of said tube, but in a direction opposite to a cellular migration from the outside to the inside of said tube.

Description

IMPLANTABLE DEVICE FOR TREATING EDEMA

The present invention relates to devices or other systems, implantable in humans or in animals to treat edematous collections.

The following description relates more particularly to implantable devices in the eye, both inside and outside of the eyeball to treat glaucoma, without the scope of the invention are is limited. In fact, the device of the invention applies to the treatment of edematous any collection of human and animal body such as cerebral edema, kidney and hydrocephalus ...

Glaucoma is an eye disease that can take sharp or particularly severe, as to cause partial or total blindness of the patient. This disease is characterized in general *, a hypertension of the eyeball, namely an increase in intraocular pressure, which increases the hardness of the world and causes compression of the optic nerve, with a decrease in visual acuity.

In ophthalmology, glaucoma are usually treated with trabeculectomy. This surgical technique is to incise the trabecular meshwork corneo-scleral, to create a valve draining the aqueous humor in pressure to the space under the conjunctiva. But to compensate for healing phenomena can be associated are introducing a biocompatible drainage tube with the eye, to remove excess aqueous humor from the anterior eye chamber.

To this end, the upstream end of the drainage tube enters and is maintained in the anterior chamber, while the other downstream end is first implanted under the scleral flap and subconjunctival, where the aqueous humor is drained to be diffused and absorbed by the surrounding tissue. The drainage tube has at least partially sufficient flexibility to adapt to the shape or to the local contour of the sclera.

Such a technique has its limitations, in that the drainage tube may be colonized by a cell proliferation and fibrosis, to the point of closing gradually, especially in its downstream end. Under these conditions, glaucoma returns gradually and requires a new intervention.

Incidentally, examples of this technique can be found in the presentations of invention WO-A-91 07195, WO-A-92 00112 and US-A-4,521,210, where the one or more drainage tubes are totally internally position and thus open into the anterior chamber flush it. To experience such a position is not satisfactory, because it prevents bad cell recolonization.

In addition, the device described in OA-91 07195 requires the use of a special pocket placed in the sclera. The device described in OA-92 00112 is not intrascleral; it is under the surface layers of the cornea, which can obviously not guarantee a continued proper place, even relatively short term. As for the device disclosed in US-A-4521210, we deem to its complexity, due in particular to be used of the side legs support (cross shape), lugs which moreover have any chance to be a discomfort to the eye or be poorly tolerated by the body.

The present invention thus relates to an implantable device comprising a drainage tube, overcoming the disadvantages of conventional trabeculectomy, and other drawbacks mentioned above, involving the installation of non-closable drain. More specifically, the invention relates to a device for diffusing the body fluid to be discharged as the aqueous humor, ensuring that it can not be closed for the duration of its presence by cell colonies.

According to the invention, the one or more drainage tubes used each have, over the major part of their length between the upstream end and the downstream end, and in particular in their part in contact with the discharge zone, a permeability side, to diffuse substantially all of the liquid discharging charged on the upstream end of the inside outwards and the wall of said tube, but opposing cell migration from the outside to the within said tube. The tube is not completely intrascleral position and extends and emerges within the anterior chamber.

Failure to fully scleral path or tubes that their respective end than the equator of the eyeball to open into an area where adjacent structures are much less dense, which effectively avoids plugging or clogging of drainage by scar process. Typically, for a human eye, the tube or tubes emerge from the scleral flap with a length between 1.5 and 3 mm.

According to the invention, a drainage tube is then comprises side diffuser of aqueous humor, and this in a particularly simple manner.

The present invention further presents the following implementation conditions: - in a first mode of implementation, the drainage tube comprises, at least in its portion in contact with the discharge zone, a plurality of pores with micro-perforations through its wall right through, and distributed in all its side surface; according to another mode of implementation, the drainage tube material is continuous, that is to say, not perforated, but semi-permeable, at least from the inside outwards, thereby allowing a continuous distribution in Similarly, the aqueous humor by simple permeation; Preferably, each drainage tube is a hollow fiber, porous, particularly having a diameter between 0.3 and 1.2 mm, and a wall thickness of more than 50 microns; - the device of the invention may comprise one or more drainage tubes, independent of each other; in the latter case, the drain tubes can be connected or retained to one another by a flat connection means, for example by a link wire or matrix type encompassing or a biocompatible glue (in particular polyurethane), and swallow the ends of the tubes are plated in the discharge zone; it is important to note here that the collection takes a single bulge corresponding to the matrix points or bonding and does not include any fastening tab as in the aforementioned US exposed; this limited thickening on the path of the tubes for attaching the device by simply folding the scleral flap, both with respect to its introduction into the anterior chamber in relation to its emergence outside the scleral flap around the eye shell; the same remarks regarding the fixing being applicable also in case there is only one tube;

- Preferably, the downstream end of the drainage tube is open; the drainage tube material is preferably hydrophilic, but can be selected from the following flexible products, namely silicone, polymethyl methacrylate (abbreviated to PMMA) and polyvinyldifluoroéthylène (PVDF), hydrogel whatsoever; Preferably, the drainage tube is a hollow fiber hydrophilic and in particular a hollow fiber derived from cellulose products, a hollow fiber of ethylene / vinyl alcohol-type material, polymethyl methacrylate, polyacrylonitrile single nitrile or coupled to the sodium methallyl-sulfonate, polysulfone and any other combination of materials to achieve a porous tubule such as those already used for artificial kidneys; the drainage tube material can also be selected from rigid products as a porous ceramic, in particular of simple alumina, zirconia-alumina and tetragonal zirconia; all of these flexible or rigid materials having benefited from any surface treatment type;

- for or realized drainage tubes, each consisting of a hollow fiber porous hydrophilic, the porosity is preferably between 10 and 95%.

Can be used for obtaining a drainage tube according to the present invention, any biocompatible polymeric material, as used to perform any intra-ocular lens can be located on the optical axis in the corneal thickness, in the anterior chamber of the eye between the iris and the natural lens (placed against the latter), or the crystalline lens capsule in place of the natural lens, or in the vitreous lodge rearmost, and capable of correcting any form of optical anomaly (aphakia, high myopia, hyperopia, astigmatism, or presbyopia and magnifying system for ocular degeneration).

Da general, the materials selected should have the following characteristics or properties: be of microporous Preferably, as to simplify the realization of tubes or, as to avoid any encroachment cell proliferation, even late;

- they are neither biodegradable nor absorbable, to allow a permanent and lasting diffusion of the liquid to be discharged; - being neither reactogenicity or irritants not favor any local fibrosis reaction, hindering the effectiveness of the medium-term device;

- be sure biocompatible, that is to say well tolerated by the human or animal body, without any form of local or general toxicity; have a particularly smooth surface, that is to say not present any roughness or major irregularities by electron microscopic observation, for example.

hydrogels and, more generally, any material used in artificial kidneys are preferred materials for obtaining or tubes belonging to a device according to the invention.

Hydrogels or "water-containing gels" are synthetic polymers absorbing water, soft but firm consistency induced by hydrophilicity and insolubility in water. These hydrogels are obtained by copolymerization of monomers having solubilizing groups water, for example hydroxyl, with other monomers, for example ethylene dimethacrylate. These hydrogels are widely used in ophthalmology, such as for corneal bandages.

For the purposes of the invention, namely obtaining tubes or tubules, hydrogels have proven well suited, since their hydrophilic to absorb water, while sOpposant a migration of cells and large molecules (MW greater than 40,000 Dalton). They also have good oxygen permeability, are transparent optically, and have proven durable in mechanical terms.

As hydrogel, acrylonitrile / sodium methallyl sulfonate are preferred as having, in particular, a large vis-à-vis liquid permeability, suitable for providing a large filter for glaucoma. Biocompatibility is excellent, since in particular it is the blood-compliant high-flow fiber known for artificial kidney.

As an example of such a material, we will refer to the commercial reference AN69 sold by the French company HOSPAL.

With the latter material, comprising by weight 30% non-crosslinked polymer and 70% water according to the invention was obtained and used tubes having an outer diameter of 340 microns, an inside diameter of 240 microns, and therefore, a wall 50 microns thick. These tubes are glycerin prior to use, have a high permeability, for example of the order of 60 ml / hr / m 2 / mmHg, with an outer diameter of less than 100 Angstroms pore.

The state of the surface of these fibers hydrogel already satisfactory at the time of obtaining can be further improved by a suitable surface treatment, for example with a treatment at room temperature, in one or more stages, with an alcohol long aliphatic chain with sequences at various temperatures.

The present invention is now described with reference to the accompanying drawings, in which:

- Figure 1 is an anatomical cross-sectional view of an eye and the scleral flap, against which a device according to the invention is installed; Figures 2, 3, 4 show, in correspondence with Figure 1, the eyeball with the scleral flap, under which a device according to the invention is installed;

- Figure 5 shows in an enlarged manner, and with partial cutaway, a drainage tube part of the device shown in Figures 1 and 2, the pores being generally invisible to the naked eye. Once implanted in the eye and the eye cavity 3, the device 1 according to the invention makes it possible to evacuate the aqueous humor from the anterior eye chamber 4 to the scleral shell 5. The device here comprises a plurality of drainage tubes 6, the upstream end or earlier 6a is implanted in the anterior chamber 4 and the other downstream end or posterior 6b is implanted under the conjunctiva 11 beyond the scleral flap 8, reference 9 representing the sclera and / or choroid. Each tube is made of a biocompatible material with the eye, in particular a hydrophilic material capable of being wetted by the aqueous humor, for example hydrogel, and has at the same time sufficient flexibility to adapt to the shape of scleral shell 5 and eyeball. As shown by Figures 1 and 5 together, each tube 6 comprises, at least in the sclera portion 6c, that is to say in its part disposed after implantation under the scleral flap 8, and in the anterior chamber 4, a porosity or microperforations plurality 6d through its wall from one side, and distributed in all its side surface. The porous tubes have lower openings v micron, to prevent cellular invasion.

In some cases, a single tube may be enough, but generally and for good regulate drainage, use will advantageously from 3 to 7 on average tubes eye.

As shown by Figure 3, the one or more drainage tubes are implanted into the eye, after cutting a scleral flap 8, which is then replaced by seam according to figure 3, the surgical procedure being described corresponding after.

As already indicated, each of tubes 6 can be replaced by a hollow fiber semi-permeable, such as those used in kidney dialysis devices, that is to say made from a semipermeable material, e.g. micro-porous polymer, such as hollow fibers or hydrogels.

An embodiment of the present invention is now described, with one or more tubes each having micro-perforations, or microporosity.

A drainage tube of the invention is preferentially delivered sterile and ready to use is located in a few minutes under the microscope for 1 intervention.

The drainage tube is then obliquely cut at both ends to allow, in the anterior chamber, a picking area at its upstream end of the aqueous humor, wider, and more easily avoid endothelial contact, by appropriate rotation the tube. At its downstream end, the cut is the same, so that the tube can, if necessary, be returned to the time of implantation, as to allow as sweet and harmonious back contact as possible.

Sterilization of perforated drainage tube can be performed:

1) directly from a sterile tube delivered in early intervention,

2) after rinsing the tube in an ultrasonic tank, with antiseptic and biocompatible product; This procedure usually requires 48 hours, but may be replaced by one of silicone applicable procedures;

3) after exposure to ethylene oxide vapor or Aldhylène (trade name).

The establishment of the drainage tube is in a simple trabeculectomy or trépanotrabulectomie practiced in Elliot bit 1.7 mm, so you can easily insert the drain tube (0.7 mm or less in diameter if three fibers of acrylonitrile polymer or derivative are used), in a slightly larger rounded orifice. The drainage tube is then pushed under the conjunctiva of radial way towards the equator of the globe it must extend to the rear.

Attaching the drainage tube may be carried out under the scleral flap or by a separate item with a prolene 10/0 yarn (0.2) in préplaquant deck in the sclera and by making a "round turn" around the tube or simply by closing the scleral flap, even having made a passing strap to the tubule further on eye shell. Before tightening any possible point, it is important to ensure, to better protect the corneal endothelium, that:

1) the length of which emerges into the anterior chamber is about 2 mm,

2) the oblique section of the upstream or front end of the tube is rotated upwards, that is to say the space between the endothelium and the drainage tube may be increasing towards the pupil, due to the oblique section of the upstream end.

By way of indication and in relation to Figure 2 showing a human eye in which the cornea has a diameter of about 12 mm, the length of the tubes 10 around the point of their meeting beam is between 4 and 5 mm and the rear portion 6c extends for example over a length of between 8 and 24 mm.

The conjunctival closure is then performed so entirely made classic, according to the custom of the surgeon, knowing that a remote opening of the limb seems more appropriate. Thus, the implementation of an efficient drainage system represented only simple and easy addition to add to a conventional surgical protocol "trabeculectomy".

This same type of drainage device can be introduced in a comparable manner in the space in which circulates the cerebrospinal fluid possibly under overpressure to the surrounding connective tissue.

Claims

1. A device (1) implantable in any living human or animal body, for discharging any liquid edematous collection comprising at least one drainage tube (6) having one end (6a) of said upstream is intended to be implanted in the serous cavity under positive pressure and another end (6b) of said downstream is intended to be implanted in a discharge zone, the tube having at least partially sufficient flexibility to adapt to the shape of the part in which it is implanted, and being made of at least one biocompatible material, characterized in that the tube has on the major part of its length between its upstream end (6a) and its downstream end (6b) and in particular in the part intended to be relationship with the discharge zone, a lateral permeability allowing diffusion of substantially all of the liquid drawn by its upstream end (6a), from the inside to the outside and the wall of said tube, but opposing cell migration from the outside to the inside of said tube, and in that the tube is not fully intrascleral position.
2. Device according to Claim 1, characterized in that for discharging the aqueous humor from the anterior eye chamber (4) to the scleral shell (5) and comprising at least one tube (6), the end (6a) upstream is intended to be implanted in the anterior chamber (4) of the eye and the other end (6b) downstream is intended to be implanted under the conjunctiva beyond the scleral flap (8) .
3. Device according to claim 1 or 2, characterized in that the tube material (6) is continuous drainage but semi-permeable, at least from the inside to the outside, and enables transmission in the same direction , of the liquid discharging.
4. Device according to claim 1 or 2, characterized in that it comprises a plurality of drainage tubes (6), independent of each other or connected to each other by a flat connection means.
5. Device according to claim 1 or 2, characterized in that the downstream end (6b) of the drain tube (6) is open.
6. Device according to claim 1 or 2, characterized in that the drainage tube material (6) is preferably hydrophilic, but can be selected from silicone, methyl polymethacrylate, polyvinyldifluoroéthylène, and hydrogels, derivatives cellulosic products, ethylene / vinyl alcohol type products, polymethyl methacrylate, and preferably polyacrylonitrile single or coupled to the sodium methallyl-sulfonate, polysulfone, and any combination to achieve a porous tubule, or from rigid products such as a porous ceramic and in particular a simple alumina, zirconia-alumina and tetragonal zirconia.
7. Device according to claim 1, characterized in that the drainage pipe is made of polyacrylonitrile / sodium methallyl sulfonate.
8. Device according to claim 1, characterized in that the drainage tube is a porous hollow fiber, particularly the porosity of which is between 10 and 95%.
9. Device according to claim 1, characterized in that the drainage tube is a hollow fiber, in particular having a diameter between 0.3 and 1.8 mm, with a wall thickness of more than 50 micrometers.
10. Device according to claim 1, characterized in that the pores of the drainage tube have a mean diameter less than 100 Angstroms.
PCT/IB1994/000284 1993-09-22 1994-09-20 Implantable device for the treatment of ×demas WO1995008310A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
FR9311476A FR2710269A1 (en) 1993-09-22 1993-09-22 An implantable device for the treatment of Óoedèmes.
FR93/11476 1993-09-22

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
AU75455/94A AU7545594A (en) 1993-09-22 1994-09-20 Implantable device for the treatment of aedemas

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WO1995008310A1 true WO1995008310A1 (en) 1995-03-30

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FR (1) FR2710269A1 (en)
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WO1998023237A1 (en) * 1996-11-29 1998-06-04 The Lions Eye Institute Of Western Australia Incorporated Biological microfistula tube and implantation method and apparatus
EP0898947A3 (en) * 1997-08-15 1999-09-08 GRIESHABER & CO. AG SCHAFFHAUSEN Method and apparatus to improve the outflow of the aqueous humor of an eye
WO2000013627A1 (en) * 1998-09-02 2000-03-16 Thomas Neuhann Device for improving in a targeted manner and/or permanently ensuring the ability of the aqueous humor to pass through the trabecular meshwork
EP1007113A1 (en) * 1996-10-25 2000-06-14 Anamed, Inc. Implantable devices and methods for controlling the flow of fluids within the body
AU721915B2 (en) * 1996-11-29 2000-07-20 Lions Eye Institute Limited Biological microfistula tube and implantation method and apparatus
EP1114627A1 (en) * 2000-01-05 2001-07-11 GRIESHABER & CO. AG SCHAFFHAUSEN Method and apparatus to improve the outflow of the aqueous humor of an eye
WO2002017832A1 (en) * 2000-09-01 2002-03-07 Ioltechnologie-Production Glaucoma drain
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EP1007113A1 (en) * 1996-10-25 2000-06-14 Anamed, Inc. Implantable devices and methods for controlling the flow of fluids within the body
EP1007113A4 (en) * 1996-10-25 2000-06-14 Anamed Inc Implantable devices and methods for controlling the flow of fluids within the body
US6544249B1 (en) 1996-11-29 2003-04-08 The Lions Eye Institute Of Western Australia Incorporated Biological microfistula tube and implantation method and apparatus
WO1998023237A1 (en) * 1996-11-29 1998-06-04 The Lions Eye Institute Of Western Australia Incorporated Biological microfistula tube and implantation method and apparatus
AU721915B2 (en) * 1996-11-29 2000-07-20 Lions Eye Institute Limited Biological microfistula tube and implantation method and apparatus
EP0898947A3 (en) * 1997-08-15 1999-09-08 GRIESHABER & CO. AG SCHAFFHAUSEN Method and apparatus to improve the outflow of the aqueous humor of an eye
WO2000013627A1 (en) * 1998-09-02 2000-03-16 Thomas Neuhann Device for improving in a targeted manner and/or permanently ensuring the ability of the aqueous humor to pass through the trabecular meshwork
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