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WO2025146618A1 - Systèmes et méthodes de traitement d'une surpression comportant une membrane élastique en contact fluidique avec un fluide corporel - Google Patents

Systèmes et méthodes de traitement d'une surpression comportant une membrane élastique en contact fluidique avec un fluide corporel Download PDF

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Publication number
WO2025146618A1
WO2025146618A1 PCT/IB2024/063324 IB2024063324W WO2025146618A1 WO 2025146618 A1 WO2025146618 A1 WO 2025146618A1 IB 2024063324 W IB2024063324 W IB 2024063324W WO 2025146618 A1 WO2025146618 A1 WO 2025146618A1
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Prior art keywords
inlet
elastic membrane
outlet
fluidic channel
fluid
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PCT/IB2024/063324
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English (en)
Inventor
Nikolaos Stergiopulos
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Ecole Polytechnique Federale de Lausanne EPFL
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Ecole Polytechnique Federale de Lausanne EPFL
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Publication of WO2025146618A1 publication Critical patent/WO2025146618A1/fr
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F9/00—Methods 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
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment
    • 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

Definitions

  • the present technology is directed to systems and methods for draining excess bodily fluid, e.g., intraocular fluid and/or cerebrospinal fluid, to maintain pressure within physiological limits, for example, for treating glaucoma and/or hydrocephalus.
  • bodily fluid e.g., intraocular fluid and/or cerebrospinal fluid
  • Glaucoma affects about 70 million people worldwide, and is a disorder associated with high pressure in the eye resulting from the generation of excess intraocular fluid (aqueous humor).
  • Aqueous humor is produced at a rate of 2-3 pl/min by the ciliary body and in a normal human eye maintains a constant intraocular pressure (“IOP”) around 12-20 mmHg.
  • IOP intraocular pressure
  • Aqueous humor exits the eye primarily through the trabecular meshwork and Schlemm’s canal, where it eventually drains to the episcleral veins.
  • aqueous humor dynamics namely the production rate from the ciliary body (aqueous humor inflow) and its outflow rate through the trabeculum.
  • aqueous humor inflow The most frequent type of glaucoma, called open-angle glaucoma, results from an increase in the fluidic resistance of the trabecular meshwork. Left untreated, this disease typically causes damage to the optic nerve, with consequent loss of vision, initially peripheral, but progressively leading to total blindness. Unfortunately, glaucoma is often asymptomatic until late in the progress of the disease.
  • Glaucoma is treated using medication, for example, the daily application of eye drops, such as Brinzolamide ophthalmic, that reduce production of aqueous humor.
  • eye drops such as Brinzolamide ophthalmic
  • Such medications do not cure glaucoma, and must be continued to be taken to maintain intraocular pressures within accepted limits.
  • such treatment may fail, and other surgical treatments are employed, such as filtering procedures or placement of a glaucoma drainage device.
  • Glaucoma drainage devices reduce intraocular fluid pressure by providing an artificial drainage pathway, thus maintaining a low IOP.
  • Previously-known glaucoma drainage devices usually comprise a structure having a drainage tube that is inserted through a small incision made in the conjunctiva. The surgeon makes a tiny incision in the sclera of the eye and creates an opening for the drainage implant device.
  • the drainage tube is placed such that the opening of the tube is disposed in the anterior chamber of the eye within the aqueous humor.
  • the tube is sutured in place with the drainage device attached to the sclera of the eye.
  • Many surgeons will place an absorbable suture around the tube at the time of surgery to prevent over- filtration through the device until a fibrous capsule has formed. Accordingly, such devices typically are not functional until about 3 to 8 weeks after the procedure, so as to prevent over-filtration.
  • hypotensive maculopathy choroidal detachment
  • fibrosis which appears progressively at long term and which, depending on its extent and severity, may raise the effective fluidic resistance of the implant, thereby raising the IOP to different, often non-physiological, levels.
  • U.S. Patent No. 5,411,473 to Ahmed describes a drainage device that includes a membrane-type valve. More specifically, Ahmed describes a drainage system including a membrane folded and held in tension between two plates to provide a slit opening, such that the membrane responds to pressure changes to open or close the slit opening.
  • Ahmed describes a drainage system including a membrane folded and held in tension between two plates to provide a slit opening, such that the membrane responds to pressure changes to open or close the slit opening.
  • the operational characteristics of the system depend on the properties of the membrane, which cannot be changed easily once the device is implanted.
  • the valve of Ahmed does not provide a true opening pressure to accurately control post-operation IOP.
  • U.S. Patent No. 6,544,208 to Ethier describes a self-regulating pressure system. More specifically, Ethier describes an implantable shunt device having a flexible tube positioned in a pressurized enclosure. In this patent, flow through the tube is dependent on a differential pressure between a pressure in the flexible tube and a pressure outside the flexible tube in the pressurized enclosure.
  • Ethier describes an implantable shunt device having a flexible tube positioned in a pressurized enclosure.
  • flow through the tube is dependent on a differential pressure between a pressure in the flexible tube and a pressure outside the flexible tube in the pressurized enclosure.
  • Ethier further describes that the pressure outside the flexible tube in the pressurized enclosure of the implantable shunt device is generated by osmotic effects. More specifically, the pressurized enclosure is filled with a solution containing a solute that generates an osmotic pressure which controls the opening pressure of the implantable shunt device.
  • the implantable shunt device includes a semi-permeable membrane affixed between support gratings that reduce deformation of the semi-permeable membrane. Unfortunately, significant deformation of the semi-permeable membrane makes it difficult to predict the osmotic pressure within the pressurized enclosure. Moreover, such a device with a pressurized enclosure may not work in higher altitudes where there is a relatively large change in atmospheric pressure.
  • U.S. Patent No. 9,101,445 to Bigler describes an ocular drainage system for treating diseases that produce elevated intraocular pressures, such as glaucoma, wherein the system includes an implantable device and an external control unit.
  • the implantable device includes a non-invasively adjustable valve featuring at least one deformable tube and a disk rotatably mounted within a housing, such that rotation of the disk using the external control unit causes the disk to apply a selected amount of compression to the deformable tube, thereby adjusting the fluidic resistance of the deformable tube and regulating the intraocular pressure.
  • U.S. Patent Nos. 5,626,558 and 6,508,779 to Suson describe a shunt which may be adjusted after implantation by using a low power laser to drill additional openings in the tube wall to adjust the flow rate.
  • U.S. Patent No. 6,186,974 to Allan et al. describes a drainage shunt having multiple layers, one of which may be a gel that swells upon absorption of fluid to adjust flow rate through the tube.
  • 6,726,664 to Yaron describes a drainage tube including a distal hook that retains the distal end of the implant within the anterior chamber of the eye, and various means, such as rods or sutures, for partially occluding the lumen of the tube to regulate flow.
  • U.S. Patent No. 6,077,299 to Adelberg, et al. describes a non-invasively adjustable valve implant for the drainage of aqueous humor for treatment of glaucoma, wherein an implant having an inlet tube is surgically inserted in the anterior chamber of the eye to allow aqueous humor to flow from the anterior chamber to a valve. After passing through a pressure and/or flow regulating valve in the implant, the fluid is dispersed along the periphery of the implant to the interior of the Tenon’s capsule where it is absorbed by the body.
  • the valve inhibits flow below, and allows flow above, a specific pressure difference between the IOP within the eye and the pressure within the bleb cavity in the Tenon’s capsule.
  • the specified pressure difference or set-point is always positive and the valve is always closed in the presence of negative pressure differences, to prevent reverse flow of fluid from the Tenon’s capsule back into the anterior chamber of the eye.
  • the valve is formed by a chamber to which the inlet tube is connected, such that the chamber is closed by a pressure sensitive valve in the shape of a flat cone.
  • the pressure regulation set point of the valve is governed by a flexible diaphragm that cooperates with an armature plate having an inclined surface, and which is configured to slide over a complementary inclined surface attached to the diaphragm. Cooperation of the inclined surface of the plate and the complementary surface causes the diaphragm to deflect depending on where the armature plate is located.
  • the armature plate is rotated, using a rotor and a set of speedreducing and torque- enhancing gears, to regulate the flow through the device.
  • the characteristics of the valve strongly depend on the configuration of the cone shaped valve.
  • the regulating mechanism is complex, including many rotating parts and gears, and this complexity poses a risk of malfunction.
  • U.S. Patent Application Pub. No. 2013/0211312 to Gelvin discloses a drainage device for implantation in the eye.
  • a flexible membrane is disposed within the housing of the drainage device.
  • Such a device would not be suitable for a person that travels to different altitudes as the pressure surrounding the device would change.
  • hydrocephalus also known as “water on the brain,” is a condition where cerebrospinal fluid (CSF) builds up in the brain’s ventricles, causing pressure to increase in the skull.
  • CSF cerebrospinal fluid
  • CSF cerebrospinal fluid
  • the body which protects and nourishes the brain and spinal cord; however, when the flow of CSF is disrupted, the fluid can build up and cause the ventricles to widen, thereby preventing the brain from functioning properly.
  • Fixed-pressure valves have a predetermined opening pressure, such that they allow CSF to drain only when the pressure in the brain exceeds a fixed threshold. While fixed-pressure valves are simple and cost-effective, do not require external adjustments, and are reliable for patients with stable CSF dynamics, such valves lack adaptability as pressure settings cannot be changed post-surgery, and further may require replacement if the patient’s CSF dynamics change over time.
  • Commercially available fixed-pressure valves include the Delta Valve (made available by Medtronic, Minneapolis, Minnesota) and Integra VP fixed-pressure valves (made available by Integra LifeSciences, San Diego, California).
  • adjustable- pressure valves are configured to allow for non- invasive adjustment of the opening pressure, e.g., using an external magnetic or mechanical tool, thereby enabling improved customization to the patient’s needs. While adjustable-pressure valves have the flexibility to adapt to changes in CSF dynamics over time, and reduces the need for additional surgeries to modify the pressure settings, such valves are typically more expensive, and the use of magnetic adjustments may interfere with MRI procedures.
  • Commercially available fixed-pressure valves include the Codman Hakim Programmable Valve (made available by Integra LifeSciences, San Diego, California), the proGAV valve (made available by Christoph Ricohke GmbH & Co. KG, Potsdam, Germany), and the Polaris and Sophy Mini valves (made available by Sophysa USA, Crown Point, Indiana).
  • the main drawbacks of programmable valves include their relatively large sizes (e.g., the Codman Hakim Programmable Valve is 18 mm in diameter and 5 mm in thickness), magnetic mechanisms for providing adjustability which may interfere with MRI imaging, and the requirement of a separate anti-siphoning mechanism.
  • the proximal site e.g., brain ventricles
  • the distal exit point e.g., peritoneum
  • the hydrocephalus shunts typically require a separate anti-siphoning mechanism.
  • the device may comprise a housing defining the inlet and the outlet.
  • the housing may be coupled to the elastic membrane to define the fluidic channel within the housing.
  • the elastic membrane may be disposed within a cavity of the housing, the cavity comprising one or more openings configured to expose the outer surface of the elastic membrane within the cavity to fluid or tissue surrounding the device at the implantation site.
  • the first bodily area may comprise a ventricle of a brain of the patient, such that the elastic membrane may be configured to deform to change the volume of the fluidic channel when the average pressure between the inlet and the outlet varies, thereby varying fluidic resistance of the flow of cerebrospinal fluid through the fluidic channel, e.g., to thereby treat hydrocephalus.
  • the device further may include a nozzle having an outlet end coupled to the inlet, and an inlet end configured to be disposed within the ventricle of the brain.
  • the device may include a drainage tube having a proximal end coupled to the outlet, a distal region configured to pass through a wall of a peritoneum to communicate with a peritoneal cavity of the patient, and a length selected such that the distal region of the drainage tube extends from the outlet to the peritoneal cavity.
  • the distal region of the drainage tube may comprise one or more drainage holes.
  • the device further may include a local constriction disposed within at least a portion of the fluidic channel to reduce the area of the fluidic channel and increase fluidic resistance of the flow of fluid through the fluidic channel.
  • a local constriction may be configured to engage the interior surface of the elastic membrane to divide the fluidic channel into a fluidic channel inlet portion in fluid communication with the inlet and a fluidic channel outlet portion in fluid communication with the outlet.
  • the elastic membrane may be configured to deform and disengage the local constriction to permit fluid flow between the fluidic channel inlet portion and the fluidic channel outlet portion when the average pressure between the inlet and the outlet varies.
  • the portion of the local constriction configured to engage the interior surface of the elastic membrane may comprise a circular ridge protruding from an outer surface of the local constriction towards the elastic membrane.
  • the circular ridge may define an inlet chamber of the fluidic channel inlet portion, such that, when the average pressure between the inlet and the outlet varies, fluid within the inlet chamber causes the elastic membrane to deform and disengage the circular ridge to permit fluid flow between the fluidic channel inlet portion and the fluidic channel outlet portion.
  • the ridge may have a height greater than a periphery of the elastic membrane to provide a pre-loaded tension to the elastic membrane.
  • the housing may comprise a circular shape, and an upper portion of the housing may comprise an inverted circular opening configured to expose the outer surface of the elastic membrane to fluid and tissue surrounding the device at the implantation site.
  • the housing, the elastic membrane, and the local constriction may be concentric.
  • a first portion of the fluidic channel inlet portion may be defined by a first inner surface of the local constriction, the first portion of the fluidic channel inlet portion fluidically coupling the inlet and the inlet chamber.
  • a first portion of the fluidic channel outlet portion may be defined by the outer surface of the local constriction and the interior surface of the elastic membrane, and the first portion of the fluidic channel outlet portion fluidically may be coupled to the outlet via a second portion of the fluidic channel outlet portion defined by a second inner surface of the local constriction.
  • a ratio of an area of the first portion of the fluidic channel outlet portion and an area of the inlet chamber may be selected to create an anti-siphoning effect.
  • the housing may comprise a tubular shape extending from the inlet to the outlet.
  • the housing may comprise one or more openings configured to expose the outer surface of the elastic membrane to fluid and tissue surrounding the device at the implantation site.
  • a longitudinal length of the one or more openings of the housing may be larger than a longitudinal length of the local constriction.
  • the one or more openings may comprise a first opening at a first portion of the housing, and a second opening at a second portion of the housing opposite the first portion of the housing, and the elastic membrane may comprise a first elastic membrane and a second elastic membrane, the first elastic membrane exposed via the first opening and configured to engage with an upper portion of the local constriction, and the second elastic membrane exposed via the second opening and configured to engage with a lower portion of the local constriction. Accordingly, when the average pressure between the inlet and the outlet varies, the first and second elastic membranes may deform and disengage the upper and lower portions of the local constriction, respectively, to permit fluid flow between the fluidic channel inlet portion and the fluidic channel outlet portion.
  • the housing may comprise a rectangular shape extending from the inlet to the outlet.
  • An upper portion of the housing may comprise a proximal tapered portion, a distal tapered portion, and an opening between the proximal and distal tapered portions, the opening configured to expose the outer surface of the elastic membrane to fluid and tissue surrounding the device at the implantation site.
  • a longitudinal length of the opening of the housing may be larger than a longitudinal length of the local constriction.
  • FIG. 1 A illustrates an exemplary device for the treatment of excess fluid pressure within an eye coupled to a nozzle and a drainage tube, constructed in accordance with some embodiments.
  • FIG. IB illustrates the device of FIG. 1A implanted on a scleral surface in accordance with some embodiments.
  • FIG. 2A is a close up view of the device of FIG. 1A
  • FIG. 2B is an exploded view of the components of the device of FIG. 2A.
  • FIG. 3 A illustrates cross-sectional views of the device of FIG. 2A when the valve is in a closed state.
  • FIG. 3B illustrates cross-sectional views of the device of FIG. 2A when the valve is in a deformed open state in response to distending pressures underneath the elastic membrane, ranging from a high inlet pressure to a low outlet pressure at each end of the device.
  • FIG. 4 is a graph illustrating exemplary steady state inlet and outlet pressures of the device in vivo.
  • FIG. 5 illustrates the exemplary device of FIG. 2A coupled to a nozzle and a diffuser plate via a drainage tube in accordance with some embodiments.
  • FIG. 6A is a schematic diagram illustrating the geometry of another exemplary device for the treatment of excess fluid pressure within an eye in accordance with some embodiments.
  • FIG. 6B is a cross-sectional view of the exemplary device of FIG. 6A when the valve is in a closed state.
  • FIG. 9A illustrates yet another exemplary device for the treatment of excess fluid pressure within an eye constructed in accordance with some embodiments.
  • any scenario causing IOP to increase will result in deformable structure equilibrating at a new, larger flow area and increased flow that will result in turn reduce IOP.
  • the expansion of elastic membrane 230 has a parabolic shape along elastic membrane 230.
  • pressure at outlet 204 increases, for example, due to the development of fibrosis at outlet 204, the average pressure within fluidic channel outlet portion 218b will increase, causing elastic membrane 230 to deform into opening 208 and disengage ridge 220, which in turn will result in increased flow area and smaller fluidic resistance within the fluidic channel of device 200. Consequently, the increase of IOP at inlet 202 will be limited.
  • device 200 may be coupled to distal end 106 of nozzle 102 via inlet 202 as described above, and further coupled to diffuser plate 506, e.g., a Seton tube, via drainage tube 500.
  • diffuser plate 506 e.g., a Seton tube
  • outlet 204 of device 200 may be coupled to proximal end 502 of drainage tube 500, and distal region 504 of drainage tube 500 may be fluidically coupled to diffuser plate 506.
  • diffuser plate 506 may include a groove shaped and sized to receive drainage tube 500, and drainage tube 500 may be maintained within the groove via, e.g., friction or an adhesive.
  • diffuser plate 506 may include one or more drainage holes along its upper surface such that the lumen of drainage tube 500 may be in communication with the upper surface of diffuser plate 506.
  • device 200 may be designed to be implanted within the diffuser plate on the scleral surface of a human eye.
  • the nozzle is sized and shaped to extend from within the diffuser plate along the curvature of the eye and to be disposed through the wall of the eye and into the anterior chamber. Flow enters the implantable device through the nozzle coupled to the inlet of the device and exits through the outlet into the diffuser plate and is ultimately deposited beneath the tissue of the eye, where it drains primarily to the connecting vein network.
  • Implantable device 600 may be constructed similar to implantable device 200.
  • inlet 602, outlet 604, and lower portion 610 of housing shell 601 correspond with inlet 202, outlet 204, and lower portion 210 of housing shell 201
  • local constriction 612 having inlet end 614, outlet end 616, openings 622, 628, circular ridge 620 defining inlet chamber 624 of fluidic channel inlet portion 618a
  • groove 626 defining a first portion of fluidic channel outlet portion 618b
  • local constriction 212 having inlet end 214, outlet end 216, openings 222, 228, circular ridge 220 defining inlet chamber 224 of fluidic channel inlet portion 218a, and groove 226 defining the first portion of fluidic channel outlet portion 218b
  • elastic membrane 630 correspond with elastic membrane 230.
  • inlet 602 is configured to be fluidically coupled to a nozzle, e.g., distal end 106 of nozzle 102
  • outlet 604 is configured to be fluidically coupled to a drainage tube, e.g., proximal end 110 of drainage tube 108.
  • Device 600 differs from device 200 in that upper portion 606 of housing shell 601 includes non-hermetic, enclosed cavity 608, such that in an assembled configuration, elastic membrane 630 is disposed within cavity 608. As shown in FIG.
  • upper portion 606 further includes one or more holes 609 sized and shaped to permit vapor to pass therethrough, e.g., even if holes 609 are covered by tissue ingrowth, such that the outer surface of elastic membrane 630 is in direct fluid contact with fluid and tissue surrounding device 600 at the implantation site.
  • FIG. 6B depicts expected operation of device 600 at low IOP levels, e.g., when there is no flow of aqueous humor through device 600
  • FIG. 6C depicts expected operation of device 600 when the average pressure between inlet 602 and outlet 604 varies, e.g., if IOP increases and/or if distal pressure increases beyond a predetermined threshold, such that fluid within fluid channel inlet portion 618a causes elastic membrane 620 to deform and disengage from ridge 620 to permit fluid flow between fluid channel inlet portion 618a and fluid channel outlet portion 618b, e.g., through the gap formed between the interior surface of elastic membrane 630 and the upper edge of ridge 620.
  • Implantable device 700 includes housing shell 701 having a tubular shape defining inlet 702, outlet 704, and a fluidic passageway/channel extending between inlet 702 and outlet 704.
  • Inlet 702 may be in the form of an inlet connector configured to be removably coupled to various drainage tubes, e.g., distal end 106 of nozzle 102
  • outlet 704 may be in the form of an outlet connector configured to be removably coupled to various drainage tubes, e.g., proximal end 110 of drainage tube 108.
  • outlet 704 may be fluidically coupled to, e.g., a diffuser plate, and/or device 700 may be disposed within a diffuser plate, as described above with regard to FIG. 5.
  • the outer surface of the inlet connector and outlet connector may have ridges for a fluid-tight connection with the additional drainage tubes such that external bodily fluids may not enter the fluidic channel of device 700 via inlet 702 and outlet 704.
  • housing shell 701 may include an opening, e.g., upper opening 706a, sized and shaped to expose an elastic membrane, e.g., upper elastic membrane 708a, such that upper elastic membrane 708a is in direct contact with fluid and tissue surrounding device 700 at the implantation site.
  • housing shell 701 may include another opening, e.g., lower opening 706b, opposite upper opening 706a and sized and shaped to expose another elastic membrane, e.g., lower elastic membrane 708b, such that lower elastic membrane 708b is in direct contact with fluid and tissue surrounding device 700 at the implantation site.
  • device 700 includes local constriction 710 disposed within at least a portion of the fluidic passageway of housing shell 701 to reduce the area of the fluidic passageway and increase fluidic resistance of the flow of fluid through the passageway.
  • local constriction 710 may be sized and shaped to define upper fluidic channel 712a between the upper surface of local constriction 710 and the interior surface of upper elastic membrane 708a, and lower fluidic channel 712b between the lower surface of local constriction 710 and the interior surface of lower elastic membrane 708b, such that fluid flowing through the fluidic channel of device 700 may flow across local constriction 710 via either upper fluidic channel 712a or lower fluidic channel 712b.
  • Local constriction 710 and housing shell 701 may be separate pieces and molded together during manufacturing of device 700, or alternatively, local constriction 710 and housing shell 701 may be formed as a single piece, and accordingly formed of the same material.
  • FIG. 8A illustrates cross- sectional views of the components of device 700 in the assembled configuration, depicting expected operation of device 700 at regular IOP levels, e.g., when the downstream external pressure is very low ( ⁇ 3 mmHg). As shown in FIG.
  • local constriction 710 divides the fluidic channel of device 700 into fluidic channel inlet portion 714a and fluidic channel outlet portion 714b, such that fluidic channel inlet portion 714a is not in fluid communication with fluidic channel outlet portion 714b when upper elastic membrane 708a and lower elastic membrane 708b are in their undeformed states and engage with local constriction 710.
  • FIG. 8B illustrates expected operation of implantable device 700 when there is, for example, an increase in IOP levels at inlet 702.
  • IOP will increase and the average pressure forces within fluidic channel inlet portion 714a will increase, which will cause upper elastic membrane 708a and lower elastic membrane 708b to bulge, e.g., deform into upper opening 706a and lower opening 706b, respectively, and disengage local constriction 710 when the average pressure forces within fluidic channel inlet portion 714a exceeds the predetermined threshold, resulting in fluid communication between fluidic channel inlet portion 714a and fluidic channel outlet portion 714b, a larger flow area, smaller fluidic resistance, and consequently a decrease in IOP, thereby allowing the IOP to be maintained at a pre-determined desired level.
  • IOP at inlet 702 decreases, for example, during the period of time right after implantation which may cause hypotony
  • the average pressure within fluidic channel inlet portion 714a will decrease, which may cause upper elastic membrane 708a and lower elastic membrane 708b to deform toward local constriction 710, thereby strengthening the seal between local constriction 710 and upper elastic membrane 708a and lower elastic membrane 708b, and increasing fluidic resistance within the fluidic channel of device 700, and further preventing fluid flow from fluidic channel inlet portion 714a to fluidic channel outlet portion 714b.
  • This in turn will limit the decrease of IOP at inlet 702 and reduce the risk of hypotony.
  • device 700 becomes an upstream pressure regulator in the sense that, if fluidic pressure within fluidic channel inlet portion 714a increases, upper elastic membrane 708a and lower elastic membrane 708b will deform into upper opening 706a and lower opening 706b, respectively, and the hydraulic resistance will decrease. In this case, the pressure at inlet 702 may be maintained relatively constant.
  • device 900 may be coupled to various drainage tubes such that fluid passing through device 900 may be deposited with an orbital fat space or on the sclera of the patient’s eye to thereby treat excess fluid pressure within a patient’s eye.
  • an inlet of device 900 may be fluidically coupled to distal end 106 of nozzle 102
  • an outlet of device 900 may be fluidically coupled to proximal end 110 of drainage tube 108 having one or more drainage holes 114 at distal region 112 of drainage tube 108.
  • the outlet of device 900 may be fluidically coupled to, e.g., a diffuser plate, and/or device 900 may be disposed within a diffuser plate, as described above with regard to FIG. 5.
  • the outer surface of the inlet connector and outlet connector may have ridges for a fluid-tight connection with the additional drainage tubes such that external bodily fluids may not enter the fluidic channel of device 900 via the inlet or outlet of device 900.
  • implantable device 900 includes housing shell 901 having a tubular shape defining inlet 902, outlet 904, and a fluidic passageway/channel extending between inlet 902 and outlet 904.
  • Inlet 902 may be in the form of an inlet connector configured to be removably coupled to various drainage tubes, e.g., distal end 106 of nozzle 102
  • outlet 904 may be in the form of an outlet connector configured to be removably coupled to various drainage tubes, e.g., proximal end 110 of drainage tube 108.
  • housing shell 901 may include proximal tapered portion 906a, distal tapered portion 906b, and opening 908 disposed between proximal tapered portion 906a and distal tapered portion 906b.
  • the cross- sectional area of housing shell 901 may decrease along proximal tapered portion 906a and along distal tapered portion 906b in the direction towards opening 908.
  • Opening 908 is sized and shaped to expose elastic membrane 910 therethrough, such that elastic membrane 910 is in direct contact with fluid and tissue surrounding device 900 at the implantation site.
  • device 900 includes local constriction 912 disposed within at least a portion of the fluidic passageway of housing shell 901 to reduce the area of the fluidic passageway and increase fluidic resistance of the flow of fluid through the passageway.
  • Local constriction 912 may have a rectangular cross-sectional area, such that the upper surface of local constriction 912 engages with the interior surface of elastic membrane 910 when elastic membrane 910 is in its undeformed state, e.g., at regular IOP levels.
  • local constriction 912 divides the fluidic channel of device 900 into fluidic channel inlet portion 914a and fluidic channel outlet portion 914b, such that fluidic channel inlet portion 914a is not in fluid communication with fluidic channel outlet portion 914b when elastic membrane 910 is in its undeformed states and engages with local constriction 910.
  • Local constriction 912 and housing shell 901 may be separate pieces and molded together during manufacturing of device 900, or alternatively, local constriction 912 and housing shell 901 may be formed as a single piece, and accordingly formed of the same material.
  • FIG. 9D is a cross-sectional view of the components of device 900 in the assembled configuration, depicting expected operation of device 900 at regular IOP levels, e.g., when the downstream external pressure is very low ( ⁇ 3 mmHg).
  • any scenario causing IOP to increase will result in deformable structure equilibrating at a new, larger flow area and increased flow that will result in turn reduce IOP.
  • the expansion of elastic membrane 910 may have a parabolic shape along elastic membrane 910.
  • pressure at outlet 904 increases, for example, due to the development of fibrosis at outlet 904, the average pressure within fluidic channel outlet portion 914b will increase, causing elastic membrane 910 to deform into opening 908 and disengage local constriction 912, which in turn will result in increased flow area and smaller fluidic resistance within the fluidic channel of device 900. Consequently, the increase of IOP at inlet 902 will be limited.
  • FIG. 10A illustrates upper portion 1006 having four openings 1008, upper portion 1006 may have less or more than four openings, each configured to expose the exterior surface of elastic membrane 1030 to fluid and tissue surrounding device 1000.

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  • Otolaryngology (AREA)
  • Neurology (AREA)
  • Anesthesiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Surgery (AREA)
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Abstract

L'invention concerne des systèmes et des méthodes pour traiter des maladies qui produisent une pression élevée, par exemple, une pression intraoculaire ou une pression de liquide céphalorachidien, telles que le glaucome ou l'hydrocéphalie, le dispositif comprenant une enveloppe de boîtier, une membrane élastique et un étranglement local qui réduit la surface du passage fluidique à travers l'enveloppe de boîtier et augmente la résistance fluidique de l'écoulement de fluide à travers le passage. Aux niveaux d'IOP normaux, la membrane élastique vient en prise avec l'étranglement local pour empêcher ou réduire l'écoulement de fluide à travers le passage. Lorsque la pression moyenne entre l'entrée et la sortie du dispositif varie, par exemple, dépasse un seuil prédéterminé, la membrane élastique se déforme et se sépare de l'étranglement local pour permettre ainsi l'écoulement de fluide à travers le passage.
PCT/IB2024/063324 2024-01-02 2024-12-31 Systèmes et méthodes de traitement d'une surpression comportant une membrane élastique en contact fluidique avec un fluide corporel Pending WO2025146618A1 (fr)

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US4457757A (en) 1981-07-20 1984-07-03 Molteno Anthony C B Device for draining aqueous humour
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US5411473A (en) 1988-10-07 1995-05-02 Ahmed; A. Mateen Medical valve
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US6077299A (en) 1998-06-22 2000-06-20 Eyetronic, Llc Non-invasively adjustable valve implant for the drainage of aqueous humor in glaucoma
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US6726664B2 (en) 1999-06-02 2004-04-27 Optonol Ltd. Flow control device, introducer and method of implanting
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US20130211312A1 (en) 2012-02-14 2013-08-15 Michael L. Gelvin Prefilled Ocular Implants and Methods
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WO2020049508A1 (fr) * 2018-09-06 2020-03-12 Ecole Polytechnique Federale De Lausanne (Epfl) Appareil pour traiter un excès de liquide intraoculaire comportant une membrane élastique
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US11779489B2 (en) 2020-03-06 2023-10-10 Ecole Polytechnique Federale De Lausanne (Epfl) Apparatus for treating excess intraocular fluid having an elastic membrane

Patent Citations (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4457757A (en) 1981-07-20 1984-07-03 Molteno Anthony C B Device for draining aqueous humour
EP0276356B1 (fr) * 1987-01-29 1991-04-17 Pudenz-Schulte Medical Research Corporation Dispositif de limitation de siphonnage
US5411473A (en) 1988-10-07 1995-05-02 Ahmed; A. Mateen Medical valve
WO1994026214A1 (fr) * 1993-05-10 1994-11-24 Pudenz-Schulte Medical Research Corporation Shunt pour fluide adapte a un ecoulement pulse
US5626558A (en) 1995-05-05 1997-05-06 Suson; John Adjustable flow rate glaucoma shunt and method of using same
US6508779B1 (en) 1995-05-05 2003-01-21 John Suson Adjustable flow rate glaucoma shunt and method of using same
US6186974B1 (en) 1997-01-10 2001-02-13 University College London And Moorfields Eye Hospital Nhs Trust Device for use in the eye
US6077299A (en) 1998-06-22 2000-06-20 Eyetronic, Llc Non-invasively adjustable valve implant for the drainage of aqueous humor in glaucoma
US6726664B2 (en) 1999-06-02 2004-04-27 Optonol Ltd. Flow control device, introducer and method of implanting
US6544208B2 (en) 2000-12-29 2003-04-08 C. Ross Ethier Implantable shunt device
US9101445B2 (en) 2011-01-14 2015-08-11 Ecole Polytechnique Federale De Lausanne (Epfl) Apparatus and methods for treating excess intraocular fluid
WO2013090231A1 (fr) * 2011-12-13 2013-06-20 Alcon Research, Ltd. Systèmes de drainage actifs dotés de soupapes actionnées par pression à double entrée
US20130211312A1 (en) 2012-02-14 2013-08-15 Michael L. Gelvin Prefilled Ocular Implants and Methods
US20130211311A1 (en) * 2012-02-14 2013-08-15 Leslie A. Field Pressure-Driven Membrane Valve for Pressure Control System
US10596035B2 (en) 2016-06-06 2020-03-24 Ecole Polytechnique Federale De Lausanne (Epfl) Apparatus for treating excess intraocular fluid
WO2020049508A1 (fr) * 2018-09-06 2020-03-12 Ecole Polytechnique Federale De Lausanne (Epfl) Appareil pour traiter un excès de liquide intraoculaire comportant une membrane élastique
US12005000B2 (en) 2018-09-06 2024-06-11 Ecole Polytechnique Federale De Lausanne (Epfl) Apparatus for treating excess intraocular fluid having an elastic membrane
US11779489B2 (en) 2020-03-06 2023-10-10 Ecole Polytechnique Federale De Lausanne (Epfl) Apparatus for treating excess intraocular fluid having an elastic membrane

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