WO2023081365A1 - Fluid drainage devices, systems, and methods - Google Patents
Fluid drainage devices, systems, and methods Download PDFInfo
- Publication number
- WO2023081365A1 WO2023081365A1 PCT/US2022/048971 US2022048971W WO2023081365A1 WO 2023081365 A1 WO2023081365 A1 WO 2023081365A1 US 2022048971 W US2022048971 W US 2022048971W WO 2023081365 A1 WO2023081365 A1 WO 2023081365A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- flow resistance
- reservoir
- conduit
- internal
- microporous
- Prior art date
Links
- 239000012530 fluid Substances 0.000 title claims abstract description 87
- 238000000034 method Methods 0.000 title claims description 45
- 239000012229 microporous material Substances 0.000 claims abstract description 99
- 208000010412 Glaucoma Diseases 0.000 claims abstract description 44
- 238000004891 communication Methods 0.000 claims abstract description 19
- 239000012982 microporous membrane Substances 0.000 claims description 59
- 239000012528 membrane Substances 0.000 claims description 58
- 230000007704 transition Effects 0.000 claims description 22
- 230000002209 hydrophobic effect Effects 0.000 claims description 21
- 230000002093 peripheral effect Effects 0.000 claims description 17
- 230000008859 change Effects 0.000 claims description 12
- 210000001519 tissue Anatomy 0.000 description 31
- 239000010410 layer Substances 0.000 description 30
- 210000001742 aqueous humor Anatomy 0.000 description 15
- 230000035699 permeability Effects 0.000 description 14
- 238000005259 measurement Methods 0.000 description 11
- 210000002159 anterior chamber Anatomy 0.000 description 8
- 230000004048 modification Effects 0.000 description 8
- 238000012986 modification Methods 0.000 description 8
- 210000000795 conjunctiva Anatomy 0.000 description 6
- 230000035515 penetration Effects 0.000 description 6
- 238000002513 implantation Methods 0.000 description 5
- 239000000463 material Substances 0.000 description 5
- 239000002356 single layer Substances 0.000 description 5
- 229920000295 expanded polytetrafluoroethylene Polymers 0.000 description 4
- 230000004410 intraocular pressure Effects 0.000 description 4
- -1 polytetrafluoroethylene Polymers 0.000 description 4
- 210000003786 sclera Anatomy 0.000 description 4
- 238000009736 wetting Methods 0.000 description 4
- 239000013060 biological fluid Substances 0.000 description 3
- 238000009792 diffusion process Methods 0.000 description 3
- 230000003628 erosive effect Effects 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 230000033001 locomotion Effects 0.000 description 3
- 238000007789 sealing Methods 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- 239000004812 Fluorinated ethylene propylene Substances 0.000 description 2
- 239000000853 adhesive Substances 0.000 description 2
- 230000001070 adhesive effect Effects 0.000 description 2
- 239000000560 biocompatible material Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 230000004406 elevated intraocular pressure Effects 0.000 description 2
- 230000007794 irritation Effects 0.000 description 2
- 230000000670 limiting effect Effects 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 229920009441 perflouroethylene propylene Polymers 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 229920002635 polyurethane Polymers 0.000 description 2
- 239000004814 polyurethane Substances 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 238000001878 scanning electron micrograph Methods 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 230000029663 wound healing Effects 0.000 description 2
- 201000004569 Blindness Diseases 0.000 description 1
- PXGOKWXKJXAPGV-UHFFFAOYSA-N Fluorine Chemical compound FF PXGOKWXKJXAPGV-UHFFFAOYSA-N 0.000 description 1
- 229920001774 Perfluoroether Polymers 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 208000002847 Surgical Wound Diseases 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- NIXOWILDQLNWCW-UHFFFAOYSA-N acrylic acid group Chemical group C(C=C)(=O)O NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 description 1
- 229920006243 acrylic copolymer Polymers 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 208000002352 blister Diseases 0.000 description 1
- 210000002987 choroid plexus Anatomy 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 206010014801 endophthalmitis Diseases 0.000 description 1
- HQQADJVZYDDRJT-UHFFFAOYSA-N ethene;prop-1-ene Chemical group C=C.CC=C HQQADJVZYDDRJT-UHFFFAOYSA-N 0.000 description 1
- 208000030533 eye disease Diseases 0.000 description 1
- 229910052731 fluorine Inorganic materials 0.000 description 1
- 239000011737 fluorine Substances 0.000 description 1
- 208000003906 hydrocephalus Diseases 0.000 description 1
- 230000002757 inflammatory effect Effects 0.000 description 1
- 208000018769 loss of vision Diseases 0.000 description 1
- 231100000864 loss of vision Toxicity 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 238000002324 minimally invasive surgery Methods 0.000 description 1
- 230000003287 optical effect Effects 0.000 description 1
- 229920003229 poly(methyl methacrylate) Polymers 0.000 description 1
- 229920002492 poly(sulfone) Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 239000004926 polymethyl methacrylate Substances 0.000 description 1
- 229920000098 polyolefin Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 229920001296 polysiloxane Polymers 0.000 description 1
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 1
- 239000004810 polytetrafluoroethylene Substances 0.000 description 1
- 229920000131 polyvinylidene Polymers 0.000 description 1
- 230000000750 progressive effect Effects 0.000 description 1
- 230000009103 reabsorption Effects 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 230000002441 reversible effect Effects 0.000 description 1
- 231100000241 scar Toxicity 0.000 description 1
- 230000037390 scarring Effects 0.000 description 1
- 229920000260 silastic Polymers 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 230000008467 tissue growth Effects 0.000 description 1
- 230000004393 visual impairment Effects 0.000 description 1
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
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0023—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity
Definitions
- the present disclosure relates generally to apparatuses, systems, and methods for draining fluid and diverting the fluid to be reabsorbed elsewhere in the body. More specifically, the disclosure relates to apparatuses, systems, and methods for draining aqueous humor from the anterior chamber of a patient's eye such that it may be reabsorbed by the body.
- Various medical interventions involve evacuating excess fluid, e.g. biological fluid, from one portion of the body and redirecting it to another location of the body where it can be reabsorbed.
- this evacuation is achieved via minimally invasive procedures such as endoscopic third ventriculostomy (ETV) and choroid plexus cauterization procedure (CPC).
- this evacuation is performed post-operatively via implantable medical devices, such as a shunt.
- shunts of different forms have been employed as treatment for numerous diseases, such as hydrocephalus and glaucoma.
- glaucoma is a progressive eye disease characterized by elevated intraocular pressure.
- Aqueous humor is a fluid that fills the anterior chamber of the eye and contributes to intraocular pressure or intraocular fluid pressure. This increase in intraocular pressure is usually caused by an insufficient amount of aqueous humor absorbed by the body. In some cases, the aqueous humor is not absorbed quickly enough or even not absorbed at all, while in other cases, the aqueous humor is additionally or alternatively produced too quickly. Elevated intraocular pressure is associated with gradual and sometimes permanent loss of vision in the affected eye. [0005] Many attempts have been made to treat glaucoma.
- a glaucoma shunt for draining a fluid from an eye to a tissue surrounding the eye, the glaucoma shunt being implantable at least in part within the tissue of the eye, the glaucoma shunt includes a shunt body that is formed from a microporous material that is arranged so as to form a reservoir within the shunt body; and a conduit having a proximal end in fluid communication with the reservoir and a distal end that opposes the proximal end, the conduit distal end being insertable into the eye so as to facilitate a drainage of the fluid into the conduit via the distal end of the conduit, wherein the conduit and the reservoir together define a flow passage along which the drainage of the fluid flows through the conduit, to the reservoir, and into the tissue surrounding the eye via the microporous material, wherein the flow passage presents a variable flow resistance along the conduit that has a plurality of sequential flow resistances with a first flow resistance and
- Example 2 further to Example 1 , wherein the shunt body has a continuous wall that defines the reservoir and a reservoir opening in the continuous wall communicating with the internal reservoir and through which the conduit is engagingly receive; and wherein at least a portion of the continuous wall has a wall portion composed of the microporous material, the wall portion having an internal side facing the internal reservoir and an opposing external side facing the exterior region of the human eye, the wall portion internal side optionally having a low porosity surface extending an entirety of the wall portion internal side, the wall portion external side optionally having an alternating surface comprising the low porosity surface disposed between high porosity surfaces.
- Example 3 further to Example 1 , wherein the first flow resistance is less than the second flow resistance.
- Example 4 further to Example 1 , wherein the first flow resistance is greater than the second flow resistance.
- Example 5 further to Example 1 , wherein the microporous material defines a third flow resistance of the flow passage.
- Example 6 further to Example 5, wherein the microporous material is configured to transition from a hydrophobic state to a hydrophilic state when exposed to the fluid, and wherein the second flow resistance optionally corresponds to a rate of change in pressure with respect to a flow rate over time as the fluid engages the microporous material that defines the reservoir.
- Example 7 further to Example 6, wherein the rate of change corresponds to a tightness in a porosity of the microporous material.
- Example 8 further to Example 7, wherein the microporous material has a variable porosity across a thickness of the microporous material.
- Example 9 further to Example 5, wherein the first flow resistance corresponds to a ratio of an inner diameter of the conduit to a thickness of the conduit.
- Example 10 further to Example 1 , wherein the first flow resistance and the second flow resistance are oriented in a series arrangement such that the fluid flowing through the flow passage optionally encounters the first flow resistance before encountering the second flow resistance.
- Example 11 further to Example 1 , wherein the variable flow resistance along the conduit further includes a third flow resistance.
- Example 12 further to Example 11 , wherein each of the first flow resistance and the third flow resistance is greater than the second flow resistance.
- Example 13 further to Example 11 , wherein each of the first flow resistance, the second flow resistance, and the third flow resistance is different from one another.
- a drainage device for directing a drainage from an internal portion of an eye to a portion of a body external to the eye, the drainage device comprising a flow passage that is configured to facilitate the drainage of a fluid from the internal portion of the eye to a surrounding tissue that is external to the eye, wherein the flow passage includes a variable flow resistance to the drainage that passes through the flow passage, the flow passage having a first flow resistance portion with a first flow resistance and a second flow resistance portion with a second flow resistance, the first flow resistance optionally being different from the second flow resistance.
- Example 15 further to Example 14, wherein the first flow resistance is less than the second flow resistance.
- Example 16 further to Example 14, wherein the first flow resistance is greater than the second flow resistance.
- Example 17 further to Example 14, wherein the flow passage is positioned between a microporous material that is configured to transition from a hydrophobic state to a hydrophilic state when exposed to the drainage, and wherein the second flow resistance optionally corresponds to a rate of change in pressure with respect to a flow rate over time as the fluid engages the microporous material.
- Example 18 further to Example 17, wherein the rate of change corresponds to a tightness in a porosity of the microporous material.
- Example 19 further to Example 18, wherein the microporous material has a variable porosity across a thickness of the microporous material.
- Example 20 further to Example 14, wherein the first flow resistance corresponds to a diameter of the flow passage.
- Example 21 further to Example 14, wherein the first flow resistance and the second flow resistance are oriented in a series arrangement such that the fluid flowing through the flow passage optionally encounters the first flow resistance before encountering the second flow resistance.
- Example 22 further to Example 14, wherein the flow passage further has a third flow resistance portion with a third flow resistance.
- Example 23 further to Example 22, wherein each of the first flow resistance and the third flow resistance is greater than the second flow resistance.
- Example 24 further to Example 22, wherein each of the first flow resistance, the second flow resistance, and the third flow resistance is different from one another.
- a method of forming a drainage device includes arranging one or more microporous materials so as to form a device body with a reservoir defined therein, the reservoir being configured to receive and accumulate fluid; and securing a conduit to the reservoir such that the conduit is in fluid communication with the reservoir, wherein the conduit and the reservoir define a flow passage of the drainage device, and wherein the flow passage includes a variable flow resistance to a drainage that passes through the flow passage, the flow passage having a first flow resistance portion with a first flow resistance and a second flow resistance portion with a second flow resistance, the first flow resistance optionally being different from the second flow resistance.
- Example 26 further to Example 25, wherein forming the reservoir comprises securing a first portion of the microporous material to a second portion of the microporous material so as to optionally form the reservoir therebetween, the method further comprising securing the conduit between the first portion and the second portion, the conduit being configured to receive the drainage.
- Example 27 further to Example 26, wherein the one or more microporous materials comprise a first layer having a first microporous membrane bonded to a second microporous membrane and a second layer comprising a third microporous membrane bonded to a fourth microporous membrane, and wherein securing the first portion to the second portion optionally comprises bonding the second microporous membrane to the third microporous membrane.
- Example 28 further to Example 27, wherein the second and third microporous membranes are bonded to each other along peripheral edges of the first and second layers to define an inflatable reservoir disposed between the second and third microporous membranes, wherein the second and third microporous membranes are optionally configured to resist tissue ingrowth, and wherein the first and fourth microporous membranes are optionally configured to permit tissue ingrowth, and wherein the second and third microporous membranes optionally have an expanded state that is maintained adjacent to the peripheral edges of the first and second layers.
- Example 29 further to Example 27, wherein securing the first portion to the second portion comprises refraining from bonding the first microporous membrane to the fourth microporous membrane.
- Example 30 further to Example 27, wherein securing the first portion to the second portion comprises arranging the first layer and the second layer in a stacked configuration such that the first microporous membrane and the fourth microporous membrane are outermost membranes of the device body and the second microporous membrane and the third microporous membrane are innermost membranes of the device body.
- a glaucoma drainage device for draining a fluid from an interior region of a human eye to an exterior region of the human eye
- the glaucoma drainage device includes a body having a continuous wall defining an internal reservoir within the body and a reservoir opening in the continuous wall communicating with the internal reservoir; and a conduit extending from the body by a conduit length, the conduit having opposing first and second conduit ends defining a passage through the conduit extending between the opposing first and second ends, the conduit first end engaging the internal reservoir opening to provide a fluidic connection between the conduit second end and the internal reservoir, the conduit length being sufficient to dispose the conduit first end at the exterior region of the human eye and to dispose the conduit second end at the interior region of the human eye, wherein at least a portion of the continuous wall optionally has a wall portion composed of a microporous material, the wall portion having an internal side facing the internal reservoir and an opposing external side facing the exterior region of the human eye, the wall portion internal side optionally having
- Example 32 further to Example 31 , wherein the wall portion defines a wall portion thickness extending between the internal side and the external side, the wall portion thickness optionally defining an internal region of the wall portion having a transition porosity that is between a porosity of the low porosity surface of the internal side and a porosity of the high porosity surface of the external side.
- Example 33 further to Example 31 , wherein the wall portion defines a wall portion thickness extending between the internal side and the external side, the wall portion thickness optionally defining an internal region of the wall portion extending between the low porosity surface of the internal side and the low porosity surface of the external side, the internal region optionally having an internal region porosity that is equal to porosities of the low porosity surfaces of the internal side and the external side.
- Example 34 further to Example 31 , wherein the wall portion defines a wall portion thickness extending between the internal side and the external side, the wall portion thickness optionally defining an internal region of the wall portion extending between the low porosity surface of the internal side and the high porosity surface of the external side, the internal region optionally having an internal region porosity that is equal to a porosity of the low porosity surface of the internal side.
- Example 35 further to Example 31 , wherein the wall portion defines a wall portion thickness extending between the internal side and the external side, the wall portion thickness optionally defining an internal region of the wall portion extending between the low porosity surface of the internal side and the high porosity surface of the external side, the internal region optionally having an internal region porosity that is equal to a porosity of the high porosity surface of the external side.
- Example 36 further to Example 31 , wherein the fluidic connection between the conduit second end and the internal reservoir further extends from the internal reservoir through the microporous material to optionally provide a fluidic communication from the internal reservoir to the exterior region of the human eye.
- Example 37 further to Example 36, wherein the fluidic communication defines a flow path through the microporous material.
- Example 38 further to Example 37, wherein the flow path through the microporous material is in a direction that is directed away from the internal reservoir.
- Example 39 further to Example 37, wherein the flow path through the microporous material proceeds from a low porosity microporous region to a high porosity microporous region.
- FIG. 1 A is an illustration of an eye with a drainage system implanted therein consistent with various aspects of the present disclosure
- FIG. 1 B is an illustration of a cross section of Detail A1 from FIG. 1 A;
- FIG. 1 C is a schematic representation of the implanted drainage device at Detail A2 in FIG. 1 B;
- FIG. 2A is a side-view illustration of a drainage system in the form of a glaucoma shunt consistent with various aspects of the present disclosure
- FIG. 2B is a bottom-view illustration of the drainage system of FIG. 2A;
- FIG. 2C is a cross-sectional view of the drainage system of FIG. 2A taken at section B-B with the drainage system in a deflated state and having a conjunctival tab;
- FIG. 2D is a cross-sectional view of the drainage system 100 of FIG. 2A taken at section C-C with the drainage system in the deflated state and having first and second layers with different microstructure and thickness;
- FIG. 2E is a perspective view of an alternative, miniature embodiment of the drainage system 100 of FIG. 2A;
- FIG. 3A is a schematic view of wall of the drainage device in a deflated state
- FIG. 3B is a schematic view of the wall of the drainage device in an inflated state
- FIG. 3C is an SEM image of a portion of the microstructure schematically illustrated in the drainage system of FIGS. 3A and 3B, with the SEM image scaled as shown;
- FIGS. 4A through 4D each shows one of various configurations of a drainage device that may have undergone modification processes to have varying degrees of resistance
- FIG. 4E is a bar graph comparing the measured pressure values associated with the components in FIGS. 4A through 4D and implications of various modifications to those components;
- FIG. 5A is a flowchart of a method of manufacture consistent with various aspects of the present disclosure
- FIG. 5B is a flowchart of a method of use consistent with various aspects of the present disclosure.
- FIGS. 6A and 6B are schematic side views of a sessile drop method test performed on a surface for determining hydrophobicity/hydrophilicity.
- the terms “about” and “approximately” may be used, interchangeably, to refer to a measurement that includes the stated measurement and that also includes any measurements that are reasonably close to the stated measurement. Measurements that are reasonably close to the stated measurement deviate from the stated measurement by a reasonably small amount as understood and readily ascertained by individuals having ordinary skill in the relevant arts. Such deviations may be attributable to measurement error, differences in measurement and/or manufacturing equipment calibration, human error in reading and/or setting measurements, minor adjustments made to optimize performance and/or structural parameters in view of differences in measurements associated with other components, particular implementation scenarios, imprecise adjustment and/or manipulation of objects by a person or machine, and/or the like, for example. In the event it is determined that individuals having ordinary skill in the relevant arts would not readily ascertain values for such reasonably small differences, the terms “about” and “approximately” can be understood to mean plus or minus 10% of the stated value.
- FIGS. 1A-1C Various features of devices, systems, and methods disclosed herein can be seen in FIGS. 1A-1C. Aspects of the present disclosure relate to drainage devices, systems, and methods for fluids including but not limited to biological fluids. More particularly, the present disclosure relates to devices, systems, and methods for draining aqueous humor from the anterior chamber ‘AC’ of an eye 10 of a patient so that the aqueous humor may be resorbed by the body elsewhere.
- FIG. 1 A is an illustration of an eye 10 with a subconjunctival space 11 between a conjunctiva 13 and a sclera 15 of the eye 10. Implanted within the eye 10 is a drainage system 100 in accordance with principles of the present disclosure.
- FIG. 1 A is an illustration of an eye 10 with a subconjunctival space 11 between a conjunctiva 13 and a sclera 15 of the eye 10.
- Implanted within the eye 10 is a drainage system 100 in accordance with principles of
- FIG. 1 B shows a cross section of detail A1 from FIG. 1A.
- FIG. 1 C shows a schematic representation of the implanted drainage device 110 at Detail A2 in FIG. 1 B.
- a mechanism is provided for reabsorption of aqueous humor that has been expelled from the anterior chamber ‘AC’ of the eye 10 to reduce or otherwise stabilize intraocular pressure.
- AC anterior chamber
- the drainage system 100 illustrated in FIGS. 1A-1 C includes a drainage device 110 for treating glaucoma.
- this glaucoma drainage device 110 has a wall 112 (best seen in FIGS. 1 B and 1 C) that has a first side 114 and a second side 116.
- Fluidly coupled to the drainage device 110 can be an intake conduit 120.
- the intake conduit 120 extends from the anterior chamber ‘AC’ of the eye 10 to the drainage device 110.
- the aqueous humor at the anterior chamber ‘AC’ then flows through intake conduit 120 and into the drainage device 110.
- the drainage device 110 can contribute to its functionality and relatively low profile in comparison to other devices known in the art.
- the drainage device 110 can comprise biocompatible materials, including microporous materials such as expanded polytetrafluoroethylene (ePTFE) as discussed below.
- the intake conduit 120 can include biocompatible materials that are flexible and suitable for use in constructing elongate members. Some such suitable materials can include silicone, polytetrafluoroethylene, polypropylene, polymethyl methacrylate, acrylic, polyurethane, silastic, and metal. Such construction of the drainage system 100 is particularly useful for surgical implantation.
- a restrictive flow ‘valve’ is added distal of the intake conduit 120 where a plate section is located.
- These devices are relatively stiff and bulky and still can result in hypotony.
- drainage devices, systems, and methods according to principles of the present disclosure include low profile devices that generate appreciable flow resistance in the early post-operation period, e.g., to avoid hypotony.
- FIGS. 1 B and 1 C a non-limiting example implantation of the drainage system 100 is shown.
- the drainage system 100 is shown disposed in a subconjunctival space 11 between the conjunctiva 13 and the sclera 15 of the eye 10.
- the drainage system 100 is shown oriented such that the first layer 114 extends along the sclera 15 and such that the second layer 116 extends along the conjunctiva 13.
- the portion of the second layer 116 that interfaces with the conjunctiva 13 may be configured to promote or permit tissue ingrowth, as discussed below.
- the portion of the first layer 114 that interfaces with the sclera 15 may additionally or alternatively be configured to promote or permit tissue ingrowth, as discussed below.
- Such configurations help minimize relative movement between the drainage device 110 and the surrounding tissue.
- the intake conduit 120 is shown in FIGS. 1 B and 1 C as extending from the drainage device 110, and extending through a scleral access, perforation, or hole ‘H’ (e.g., made by a physician during the implantation procedure according to known methods) such that a first end 122 (e.g., a proximal end) accesses the anterior chamber ‘AC’ and places a port 271 in communication therewith.
- aqueous humor enters the first end 122 of the intake conduit 120 and travels to a second end 124 (e.g., a distal end) of the intake conduit 120 in fluid communication with the drainage device 110.
- the wall 112 and the intake conduit 120 can define a flow passage 140 along which the drainage flows through the drainage device 110.
- the second end 124 is positioned within the drainage device 110 such that the evacuated aqueous humor enters a reservoir 130 defined within the drainage device 110 and penetrates through the various diffusion membranes of the drainage device 110, where the aqueous humor is then absorbable by the surrounding and/or ingrown tissue.
- FIGS. 2A-2E various aspects of an example drainage system 100 in the form of a glaucoma shunt 110 are shown.
- FIG. 2A shows a sideview illustration of a drainage system 100.
- FIG. 2B shows a bottom-view illustration of the drainage system 100 of FIG. 2A.
- FIG. 2C shows a cross-sectional view of the drainage system 100 of FIG. 2A taken at section B-B with the drainage system 100 in a deflated state.
- This drainage system 100 illustrates a conjunctival tab to prevent erosion of the conjunctiva 13 by the conduit 120, a neck where the conduit 120 is bonded (e.g., via adhesive at “b”) to the wall 112, and a reservoir 130 at a distal end of the conduit 120.
- FIG. 2D shows a cross-sectional view of the drainage system 100 of FIG. 2A taken at section C-C with the drainage system 100 in the deflated state.
- FIG. 2E shows a perspective view of an alternative, miniature embodiment of the drainage system 100 of FIG. 2A.
- the drainage system 100 relates to draining fluid from one portion of a patient’s body to another.
- the conduit 120 can be inserted into the reservoir 130 at variable depth such as at a shallow depth as shown in FIG. 2C or a major depth in as shown in FIG. 2D so long as fluid is allowed to escape the distal end 124 of the conduit 120 to fill the reservoir 130.
- Such devices can have a low profile with appreciable fluid flow resistance in the early post-operation period to avoid hypotony.
- the drainage system 100 shown in these figures is useful for draining a fluid from the eye.
- This drainage can proceed from an internal portion (e.g., the anterior chamber) of the eye to a surrounding tissue external to an eye.
- the drainage device 110 can include a wall 112 that defines a reservoir 130 disposed within the wall 112.
- the reservoir 130 can be configured to be in fluid communication with the eye to receive the drainage from the internal portion of the eye into the reservoir 130.
- the wall 112 may be integrated into or altogether form a body of the drainage device 110.
- the body can have a wall 112 defining an internal reservoir 130 within the body and an internal reservoir opening (e.g., at or around adhesive ‘b’ in FIG.
- the wall 112 can include a microporous material that transitions from a hydrophobic state to a hydrophilic state.
- the wall 112 is configured to provide a variable flow resistance as the wall 112 transitions from the hydrophobic state to the hydrophilic state.
- the drainage device 110 can include a flow passage 140 that is configured to facilitate the drainage of a fluid from the internal portion of the eye to a surrounding tissue that is external to the eye.
- the flow passage 140 can include a variable flow resistance to the drainage that passes through the flow passage 140.
- the flow passage 140 can have a first flow resistance portion with a first flow resistance and a second flow resistance portion with a second flow resistance.
- the first flow resistance can be different from the second flow resistance.
- the wall 112 can be a multi-layered structure comprising one or more microstructures.
- the wall 112 can also be a continuous single-layer structure comprising multiple sub-layers within the continuous single-layer structure or that can define opposing sides of the continuous single-layer structure that present one porosity on a first side and a second porosity on a second side of the single-layer structure.
- examples of the wall 112 can include a first layer 114 having a first microporous membrane 241 engaging a second microporous membrane 242 and a second layer 116 comprising a third microporous membrane 243 engaging a fourth microporous membrane 244.
- this engaging between the first and second microporous membranes 241 , 242 and the third and fourth microporous membranes 243, 244 is such that the first and second microporous membranes 241 , 242 and the third and fourth microporous membranes 243, 244 respectively are integrally formed with each other.
- the first and second layers 114, 116 can comprise more or less microporous membranes, some such configurations are discussed in US Application No. 15/922,692 entitled “Integrated aqueous shunt for glaucoma treatment” and filed on March 15, 2018, the full contents of which are incorporated herein by reference.
- the presentation of varying microporous materials within the continuous single-layer structure can facilitate operation of the reservoir 130.
- the fluid can engage the microporous material of the wall 112.
- the second and third microporous membranes 242, 243 are engaging each other along peripheral edges 247 of the drainage device 110.
- the second and third microporous membranes 242, 243 can engage at the periphery of the first and second layers 114, 116 to define a reservoir 130 disposed between the second and third microporous membranes 242, 243.
- This engagement can be a bond that is a hermitically sealing bond, e.g., to ensure structural integrity of the reservoir 130.
- the second and third microporous membranes 242, 243 may initially contact or be in close proximity to one another such that, to initially inflate the reservoir 130, the fluid can engage the interface between the second and third microporous membranes 242, 243.
- the reservoir 130 can be configured to move between a deflated state in which the second and third microporous membranes 242, 243 resist fluid flow therebetween and an inflated state in which fluid is allowed to flow between the second and third microporous membranes 242, 243.
- first and fourth microporous membranes 241 , 244 can remain unbonded to each other while in other instances it may be useful to engage them to one another (e.g., similarly to the engagement of the second and third microporous membranes 242, 243).
- Arrangement of the microporous material to form the wall 112 can be such that wetting of the microporous material is promoted at an external side 253 of the wall 112 before an internal side 251 of the wall 112.
- the internal side 251 of the wall 112 can form the reservoir 130.
- the first layer 114 and the second layer 116 are in a stacked configuration such that the first microporous membrane 241 and the fourth microporous membrane 244 are the outermost membranes of the wall 112 and the second microporous membrane 242 and third microporous membrane 243 are the innermost membranes of the wall 112.
- the microporous material can comprise ePTFE.
- the microporous material can be configured to transition from the hydrophobic state to the hydrophilic state based on a wetting of the microporous material with the fluid, and wherein the microporous material is configured such that wetting of an outer portion of the wall 112 occurs before wetting of the surfaces defining the reservoir 130.
- the hydrophilic state promotes tissue ingrowth.
- the hydrophilic state can define a first side of the microporous material, and the hydrophobic state can define a second side of the microporous material.
- other materials similar to ePTFE are contemplated.
- Those other materials can include polymers, such as, but not limited, to polyethylene, polyurethane, polysulfone, polyvinylidene fluorine (PVDF), polyhexafluoropropylene (PHFP), perfluoroalkoxy polymer (PFA), polyolefin, fluorinated ethylene propylene (FEP), acrylic copolymers and other suitable fluorocopolymers.
- PVDF polyvinylidene fluorine
- PHFP polyhexafluoropropylene
- PFA perfluoroalkoxy polymer
- FEP fluorinated ethylene propylene
- acrylic copolymers such as, but not limited, to polyethylene, polyurethane, polysulfone, polyvinylidene fluorine (PVDF), polyhexafluoropropylene (PHFP), perfluoroalkoxy polymer (PFA), polyolefin, fluorinated ethylene propylene (FEP), acrylic copoly
- Drainage from the internal portion of the eye can flow through the drainage device 110 via a flow passage 140 as exemplified in FIGs. 1 C and 2D but also as presented in other figures defining a reservoir and/or a tube to allow a fluid to pass into the device.
- the flow passage 140 can include portions (e.g., some or all) of the wall 112 and, optionally, an intake conduit 120 as discussed in further detail below.
- fluid can flow into the reservoir 130 via the flow passage 140 after being received at the wall 112 via an intake conduit 120 or directly and then out of the reservoir 130. For instance, upon a first instance of the reservoir 130 filling with fluid, the reservoir 130 can gradually move from the deflated state toward the inflated state.
- the fluid can then remain in the reservoir 130 until portions of the wall 112 transition from the hydrophobic state to the hydrophilic state.
- the biologic fluid can penetrate through the wall 112 (e.g., from the internal side 251 of the wall 112 to either the external side 253 or peripheral edge of the wall 112) to be diverted into surrounding portions of the body at the wall 112.
- the bonding of the microporous material can occur at the peripheral edges 261 , 262, 263, 264of the microporous membranes 241 , 242, 243, 244 in the drainage device 110.
- the first microporous membrane 241 is shown with a first peripheral edge 261
- the second microporous membrane 242 is shown with a second peripheral edge 262
- the third microporous membrane 243 is shown with a third peripheral edge 263
- the fourth microporous membrane 244 is shown with a fourth peripheral edge 264.
- any combination of these microporous membranes 241 , 242, 243, 244 can be bonded at their respective peripheral edges 261 , 262, 263, 264.
- the second and third microporous membranes 242, 243 are bonded at their peripheral edges 262, 263 to form the reservoir 130 therebetween the second and third microporous membranes 242, 243.
- the first and fourth microporous membranes 241 , 244 are unbonded from the second and third peripheral edges 262, 263 of the second and third microporous membranes 242, 243 respectively.
- the first and fourth microporous membranes 241 , 244 are unbonded from each other in part or entirely.
- the bonding at peripheral edges 261 , 262, 263, 264 of the microporous membranes 241 , 242, 243, 244 can be a sealing bond and can optionally accommodate and sealingly bond additional structures, such as the intake conduit 120, to the drainage device 110.
- the bonding can be applied as described except between the first and second membranes 241 and 242 which can be replaced with a single unified layer with sub-layers having the properties of the first and second membranes, and except between the third and fourth membranes 243 and 244 which can likewise be replaced with a single unified layer with sub-layers having the properties of the third and fourth membranes.
- the continuous wall 112 can have a wall portion (e.g., some or all of the wall 112) composed of a microporous material.
- the wall portion can have a wall portion internal side 251 facing the internal reservoir 130 and a wall portion external side 253 that opposes the wall portion internal side 251 and faces the exterior region of the human eye.
- the wall portion internal side 251 can have a low porosity surface extending an entirety of the wall portion internal side 251.
- the wall portion external side 253 can have an alternating surface comprising the low porosity surface disposed between high porosity surfaces.
- the conduit 120 can be arranged so as to be extending from the body by a conduit length.
- the conduit 120 can have opposing first and second conduit ends 122, 124 defining a passage through the conduit 120 such that the passage extends between the opposing first and second conduit ends 122, 124.
- the first conduit end 122 can be engaging the internal reservoir opening to provide a fluidic connection between the second conduit end 124 and the internal reservoir 130.
- the conduit length can be sufficient enough to dispose the first conduit end 122 at the exterior region of the human eye and to dispose the second conduit end 124 at the interior region of the human eye.
- the fluidic connection between the second conduit end 124 and the internal reservoir 130 further extends from the internal reservoir 130 through the microporous material to provide a fluidic communication from the internal reservoir 130 to the exterior region of the human eye.
- This fluidic communication can define a flow path through the microporous material.
- the flow path through the microporous material can be in a direction that is directed away from the internal reservoir 130 and/or proceeds from a low porosity microporous region to a high porosity microporous region.
- FIGS. 1A-1 C and 2A-2D show a drainage system 100 having a wall 112 with a reservoir 130 defined therein and an intake conduit 120 that is in fluid communication with the reservoir 130.
- the drainage system 100 relates to draining fluid from one portion of a patient’s body to another.
- Such devices can have a low profile with appreciable fluid flow resistance in the early post-operation period to avoid hypotony.
- This device 110 may be smaller in size (e.g., in one or multiple dimensions, including length, width, and thickness) and therefore more suitable for smaller patients than the device 110 in FIGS. 2A-2D.
- thickness of the device 110 may range from about 25 pm to about 30 pm, about 30 pm to about 40 pm, about 40 pm to about 50 pm, about 50 pm to about 60 pm, from about 60 pm to about 70 pm, from about 70 pm to about 80 pm, from about 80 pm to about 90 pm, from about 90 pm to about 100 pm, from about 10 pm to about 150 pm, from about 150 pm to about 200 pm, from about 200 pm to about 250 pm, from about 250 pm to about 300 pm, from about 300 pm to about 350 pm, from about 350 pm to about 400 pm, from about 400 pm to about 450 pm, from about 450 pm to about 500 pm, or any other suitable value or range therebetween and/or combination of ranges thereof.
- the drainage system 100 shown here is similar in many respects to the drainage systems discussed above.
- the drainage system 100 shown here can include first and second layers as discussed with respect to FIGS. 2A-2D. These layers are bonded (e.g., at second and third microporous membranes) around an intake conduit 120 similar to that discussed with respect to FIGS. 1A-1 C.
- the distal end of the intake conduit 120 can be positioned (e.g., more proximally or distally than illustrated, suspended between or positioned along the internal side of the reservoir 130, etc.) such that it is in communication with the reservoir 130.
- Other variations will be apparent to those skilled in the art.
- the intake conduit 120 can be a hollow member that is optionally elongate and flexible, such as a shunt.
- the intake conduit 120 can be arranged to be in fluid communication with the reservoir 130 and optionally in sealing engagement therewith.
- the intake conduit 120 can have the second end thereof communicating with the reservoir 130 and the opposing first defining a port.
- the first end can be a proximal end of the intake conduit 120
- the second end can be a distal end of the intake conduit 120.
- the intake conduit 120 can be configured for placement within the eye to facilitate a drainage from the internal portion of the eye, through the port, and to the reservoir 130.
- FIGS. 3A-3C show cross- sectional views of the wall 112 in the drainage system with a reservoir 130 disposed therein taken along a midsection of a width of the drainage system. More specifically, FIG. 3A shows the drainage device in a deflated state (where little to no fluid is in the reservoir 130); and FIG. 3B shows the drainage device in an inflated state (where fluid has collected in the reservoir 130 so as to cause the reservoir 130 to inflate).
- FIG. 3A shows the drainage device in a deflated state (where little to no fluid is in the reservoir 130); and FIG. 3B shows the drainage device in an inflated state (where fluid has collected in the reservoir 130 so as to cause the reservoir 130 to inflate).
- FIG. 3A shows the drainage device in a deflated state (where little to no fluid is in the reservoir 130); and FIG. 3B shows the drainage device in an inflated state (where fluid has collected in the reservoir 130 so as to cause the reservoir 130 to inflate).
- 3C is a close-up view of a microstructure in the drainage system of FIGS. 3A and 3B. Displayed at the bottom of FIG. 3C is: “5.00kV 4.2mm x500 SE 1/23/2018,” and the distance between two consecutive lines as shown at the bottom right hand corner represents 10 pm.
- a microstructure through which fluid penetrates, can be included within a portion (e.g., some or all) of the microporous material.
- the microstructure can comprise multiple deposits of microporous membranes therein such that the microporous material is a multimembrane material. Grouped or coupled deposits of microporous membranes can form a layer of the microporous material, which can be overlapped, folded, or similarly arranged.
- a reservoir 130 can be formed with a reservoir proximal section 231 and a reservoir distal section 232 and can diffuse collected fluid into surrounding tissue outside of the wall 112.
- Inflation of the reservoir 130 can occur at the unbonded portions of the wall 112.
- the second and third microporous membranes 242, 243 can be bonded at their peripheries such that interior portions thereof are unbonded. As these portions are unbonded, they are free to separate from each other (or one from the other) to allow the reservoir 130 to fill with fluid.
- the reservoir 130 can have a reservoir proximal section 231 , which can be positioned adjacent the distal end of the intake conduit as further discussed below, and a reservoir distal section 232 that is positioned opposite of the reservoir proximal section 231 . Fluid flow into (or within) the reservoir 130 can be directed from the distal end of the intake conduit toward a periphery of chamber.
- the reservoir proximal section 231 can be configured to inflate before the reservoir distal section 232.
- second and third microporous membranes 242, 243 of the wall 112 can be situated adjacent to each other and can optionally be in contact with each other. As the reservoir 130 fills, the second and third microporous membranes 242, 243 can be gradually forced apart by fluid flowing into the reservoir 130. For instance, because the interior surface of the reservoir 130 can initially be hydrophobic, flow into the reservoir 130 can build pressure thereby forcing inflation of the reservoir 130 (e.g., second and third chambers being forced away from each other).
- variable flow resistance can be imparted to the fluid flow.
- the variable flow resistance can correspond to a rate of change in pressure with respect to flow rate over time.
- the wall 112 transitions from the hydrophobic state having a first flow resistance, to a partially hydrophilic state having a second flow resistance, to the hydrophilic state having a third flow resistance; and wherein the first flow resistance is greater than both the second flow resistance and the third flow resistance, and the second flow resistance is greater than the first flow resistance.
- Diffusion rates of fluid from the reservoir 130 through the wall 112 can be influenced by the flow rate, which increases with decreasing flow resistance.
- this diffusion can occur in many directions (e.g., radially outward from the reservoir 130, through unbonded portions of the peripheral edge, etc.).
- the reservoir 130 can move from the inflated state toward the deflated state.
- the reservoir 130 can move from the deflated state toward the inflated state.
- the reservoir 130 can remain in the inflated state, in an intermediate state between the inflated and deflated states. In any of these instances, there is a pressure associated with the amount of flow and/or a fill level of the reservoir 130. After collection of the fluid in the reservoir 130, fluid can be diffuse via penetration through the wall 112 at various rates depending on the state of transition of the microporous material.
- Permeabilities of each layer of the microporous material can vary across dimensions (e.g., the thickness or length) of the microstructure therein. Under these circumstances, in certain instances, a first microporous membrane 241 permeability of the first microporous membrane 241 can be higher than a second microporous membrane 242 permeability of the second microporous membrane 242. Similarly, a fourth microporous membrane 244 permeability of the fourth microporous membrane 244 can be higher than a third microporous membrane 243 permeability of the third microporous membrane 243. In examples, the second microporous membrane 242 permeability can be about the same as the third microporous membrane 243 permeability.
- the first microporous membrane 241 permeability can be about the same as the fourth microporous membrane 244 permeability.
- each of the second microporous membrane 242 permeability and the third microporous membrane 243 permeability are different from the first microporous membrane 241 permeability and the fourth microporous membrane 244 permeability.
- Porosities of membranes within the microporous material can be arranged to influence tissue ingrowth capabilities at portions thereof. It may be desired that tissue ingrowth occurs at portions of the wall 112 (e.g., at an external side 253 of the wall 112) and resisted at other portions of the wall 112 (e.g., at the reservoir 130). Tissue ingrowth at the external side 253 of the wall 112 can fix the device at an implanted location, and resisting ingrowth at the reservoir 130 can inhibit the reservoir 130 from being uninflatable due to tissue growth across the reservoir 130. For this function to be achieved, porosity at one side of the microporous material can be greater than that of another opposing side of the microporous material.
- the microporous material can have a tight side (e.g., where the porosity is greater) and an open side (e.g., where the porosity is lesser).
- the second and third microporous membranes 242, 243 can be configured to resist tissue ingrowth.
- the first and fourth microporous membranes 241 , 244 are configured to permit tissue ingrowth, and wherein the second and third microporous membranes 242, 243 have an expanded state that is maintained adjacent to the bonded peripheral edges of the first and second layers 114, 116.
- Penetrations in the microstructure can permit penetration of fluid into the microporous material. These penetrations can vary in size, e.g., based on the function of a given microporous membrane.
- first and fourth microporous membranes 241 , 244 can include penetrations that range in size (or average size) to permit ingrowth of vessels and other tissues.
- second and third microporous membranes 242, 243 are configured or selected such that the penetrations therein are generally sized to minimize, resist, or prevent the ingrowth and attachment of tissue, while maintaining aqueous humor permeability.
- Internal portions of the microporous material can have varying porosities as can be seen in FIG. 3C.
- the internal portions can extend between the wall internal side 251 and the wall external side 253.
- the porosity can comparatively range in degree from low porosity (LP), medium- low porosity (MLP), medium porosity (MP), medium-high porosity (MHP), and high porosity (HP).
- LP low porosity
- MLP medium- low porosity
- MP medium porosity
- MHP medium-high porosity
- HP high porosity
- the wall portion internal side 251 typically has a low porosity throughout (e.g., to resist tissue ingrowth into the reservoir 130), and portions of the interior portions and wall portion external side 253 can have any of the aforementioned degrees of porosity.
- the flow passage through the microporous material from the reservoir 130 to tissue surrounding the device can be represented as LP- MP-HP. More examples are discussed here below.
- Various flow paths can be present within the microporous material.
- Relatively linear flow paths may comprise regions LP1-LP4-LP5, for example or LP3- MHP1-MP1-MLP1 .
- at least some flow may proceed through the most direct path through the microporous material, such as LP1-LP4-LP5 or LP2-HP1-HP2.
- some flow paths may be relatively straight, there are also flow paths that are nonlinear. For instance, under certain conditions, at least some flow may proceed to flow through areas of increasingly less resistance such as LP1-HP1-HP2 or LP3-MHP1-HP1-HP2.
- the microstructure of the microporous materials may undergo modification processes to obtain certain types of flow through the microstructure.
- the microstructure may have relatively uniform layers across layered within the microstructure, or as shown here, have variable portions throughout the thickness of the microporous material.
- the wall portion defines a wall portion thickness extending between the wall portion internal side 251 and the wall portion external side 253.
- the wall portion thickness can define an internal region of the wall portion having a transition porosity that is between a porosity of the low porosity surface of the wall portion internal side 251 and a porosity of the high porosity surface of the wall portion external side 253.
- the internal region can have an internal region porosity that is equal to porosities of the low porosity surfaces of the internal side and the external side.
- the internal region can have an internal region porosity that is equal to a porosity of the low porosity surface of the internal side.
- the internal region can have an internal region porosity that is equal to a porosity of the high porosity surface of the external side.
- FIGS. 4A through 4E show various configurations of drainage devices with different modifications to achieve certain flow resistances along a flow path provided by the wall 112 and the conduit 120.
- four configurations (FIGS. 4A, 4B, 4C, and 4D) are shown where a tightness (as indicated by the distance between consecutive x marks along the internal side 251 ) of the microporous material in the wall 112 and/or the inner diameter of the conduit 120 (diameter D1 or D2 according to the configurations) is modified.
- the configuration of FIG. 4A can be considered a base configuration where the microporous material in the wall 112 has a nominal porosity and the diameter of conduit 120 is a nominal diameter D1.
- the configuration of FIG. 4A can be considered a base configuration where the microporous material in the wall 112 has a nominal porosity and the diameter of conduit 120 is a nominal diameter D1.
- FIG. 4A the configuration of FIG. 4B shows a similar tightness but a smaller inner diameter D2 (where, by definition, D2 ⁇ D1 ) of the conduit 120 which may increase flow resistance thereat.
- D2 the configuration of FIG. 4C shows a tighter porosity (x marks are positioned closer together along the internal side 251 of the wall 112) but a similar inner diameter (D2).
- the configuration of FIG. 4D shows the similarly tight porosity as in the configuration of FIG. 4C but the nominal inner diameter D1 similar to the configuration of FIG. 4A.
- the configurations of FIGS. 4A through 4D also show “resistors” R1 (for the conduit 120) and R2 (for the wall 112) and FIG.
- FIG. 4E shows how pressure along the flow path can change by modifying R1 and R2 at various points.
- reducing the inner diameter from D1 to D2 may increase the pressure by +6.9 mmHg (from FIG. 4Ato FIG. 4B)
- increasing the tightness of the internal side 251 of the wall 112 may increase the pressure by +91.8 mmHg (from FIG. 4B to FIG. 4C)
- increasing the inner diameter from D2 to D1 while maintaining the tightness may decrease the pressure by -8.3 mmHg (from FIG. 4C to FIG. 4D).
- the pressure along the flow path may be measured at the first end (proximal end) 122, which is where the fluid flows into the intake conduit 120, as shown by the bold arrow labeled “Flow Direction”. Furthermore, the fluid passes into the reservoir 130 and leaves the device through the external side 253 of the wall 112 as shown by the bold curved arrows.
- the tightness of the external side 253 may remain the same as the tightness of the internal side 251 is modified. In some examples, the effect of modifying the tightness of the external side 253 may be negligible or minimal compared to the effect of modifying the tightness of the internal side 251 of the wall 112.
- Modifications to the microporous material and/or conduit 120 can be used to tune an overall flow resistance of the drainage device.
- the first flow resistance and the second flow resistance can be oriented in a series arrangement such that the fluid flowing through the flow passage encounters the first flow resistance before encountering the second flow resistance.
- the first flow resistance corresponds to a diameter of the flow passage.
- inner and/or outer diameters of the conduit 120 can define the first flow resistance.
- the flow passage extends between a microporous material (e.g., from the conduit 120 when one is present) that is configured to transition from a hydrophobic state to a hydrophilic state when exposed to the drainage such as when the reservoir is in an initial uninflated state.
- the second flow resistance can correspond to a rate of change in pressure with respect to a flow rate over time as the fluid engages the microporous material.
- the microporous material has a variable porosity across a thickness of the microporous material.
- the rate of change corresponds to a tightness in a porosity of the microporous material.
- Example combinations of flow resistances along the flow passage will now be described. Drainage flowing through the flow passage can encounter the plurality of flow resistances defined therein. Each flow resistance in the plurality of flow resistances at various components or portions of components. Each such flow resistance can vary in magnitude along the length of the flow passage.
- the first flow resistance and the second flow resistance can be said to be oriented in a series arrangement in view of the configurations of FIGS. 4A through 4D.
- fluid flow through the flow passage can encounter the first flow resistance (e.g., ‘R1’) before encountering the second flow resistance (e.g., ‘R2’).
- R1 and R2 can be representative of a single component (e.g., the intake conduit 120 or the drainage device 110) in the drainage system 100, or of multiple components (e.g., R1 is the intake conduit 120 and R2 is the drainage device 110) in the drainage system 100 to represent a plurality of sequential flow resistances as shown in FIGS.
- the first flow resistance portion can be provided by the conduit 120, and the second flow resistance portion can be provided by the wall 112 of the drainage device. In further instances, both the first and third flow resistance portions can be provided by the conduit 120 or alternatively provided by the wall 112. In and of these examples, the first flow resistance can be less than the second flow resistance. In other examples, the first flow resistance can be greater than the second flow resistance.
- the flow passage can have additional flow resistances (e.g., third, fourth, fifth, and so on).
- the flow passage can have a third flow resistance portion with a third flow resistance.
- each of the first flow resistance and the third flow resistance can be higher than the third flow resistance.
- each of the first flow resistance, the second flow resistance, and the third flow resistance can be different from one another.
- the first and second flow resistances can be defined by the intake conduit 120, and the third flow resistance can be defined by the drainage device 110.
- the first and second flow resistances can be defined by the drainage device 110, and the third flow resistance can be defined by the intake conduit 120.
- each of the first, second, and third flow resistances can be defined by the intake conduit 120 or alternatively by the drainage device 110.
- FIG. 5A shows a flowchart of a method 500 consistent with aspects of the present disclosure.
- the method 500 can be useful for forming glaucoma drainage device is disclosed herein and can include drainage systems disclosed elsewhere herein, including the drainage system 100.
- the method 500 can include arranging a first portion of a first microporous material over a second portion of a second microporous material. Each of the first microporous material and the second microporous material that transitions from a hydrophobic state that to a hydrophilic state.
- the method 500 can include securing the first portion to the second portion so as to form a wall that has a reservoir therebetween.
- the reservoir can be configured to be in fluid communication within the eye to receive a drainage from an internal portion of the eye into the reservoir.
- the wall can define a variable flow resistance as the wall transitions from the hydrophobic state to the hydrophilic state.
- the method 500 can include securing an intake conduit between the first portion and the second portion.
- the intake conduit can be configured to receive the drainage.
- securing the first portion to the second portion can include arranging the first layer and the second layer in a stacked configuration such that the first microporous membrane and the fourth microporous membrane are the outermost membranes of the wall and the second microporous membrane and third microporous membrane are the innermost membranes of the wall.
- FIG. 5B Another method 550 is shown in FIG. 5B. This method a method of use for drainage devices disclosed elsewhere herein, including the drainage device 110.
- the method 550 can include directing a drainage from an internal portion of the human to flow toward a reservoir in a drainage device.
- the method 550 can include directing the drainage to encounter a first flow resistance of a flow passage.
- the method 550 can include collecting drainage in the reservoir until microporous material transitions from a hydrophobic state to a partially hydrophilic state.
- the method 550 can include directing the drainage to flow from the reservoir to a portion of the body external to the eye via compliant wall.
- FIGS. 1A-1 C The system shown in FIGS. 1A-1 C is provided as an example of the various features of the system and, although the combination of those illustrated features is clearly within the scope of invention, that example and its illustration are not meant to suggest the inventive concepts provided herein are limited from fewer features, additional features, or alternative features to one or more of those features shown in FIGS. 1A-1 C.
- the components and/or characteristics of the system shown in FIG. 1A-1C may include the components and characteristics described with reference to any other figure, such as FIGS. 2A-2E, 3A-3C, 4A through 4E, and 5A and 5B. It should also be understood that the reverse is true as well.
- FIGS. 2A-2E, 3A-3C, 4A through 4E, and 5A and 5B It should also be understood that the reverse is true as well.
- FIGS. 1A-1C can be employed in addition to, or as an alternative to components depicted in FIGS. FIGS. 2A-2E, 3A-3C, 4A through 4E, and 5A and 5B. This goes for any figure and the components and characteristics shown therein and discussed with reference thereto herein.
- FIGS. 6A and 6B show an example of how to test whether a surface is hydrophobic or hydrophilic, also referred to as a “sessile drop method”. Such a test is typically performed with an optical tensiometer which ranges from manual instruments to completely automated systems.
- a drop of liquid or fluid (“Liquid”) is placed on a surface that is to be tested, which in this case is the wall 112 (represented by the horizontal arrow) of the glaucoma drainage device 110.
- a static contact angle (0) of the liquid is measured from the surface, i.e. the wall 112, by taking an image of the drop using a high-resolution camera, from which the contact angle may be automatically determined using any suitable software.
- the contact angle is an obtuse angle, i.e. greater than 90 degrees, which indicates that the surface of the wall 112 is hydrophobic.
- the contact angle is an acute angle, i.e. less than 90 degrees, which indicates that the surface of the wall 112 is hydrophilic.
- the transition from the hydrophobic state to the hydrophilic state constitutes a decrease in the contact angle by at least 10 degrees, at least 15 degrees, at least 20 degrees, at least 25 degrees, at least 30 degrees, at least 35 degrees, at least 40 degrees, at least 45 degrees, at least 50 degrees, at least 55 degrees, at least 60 degrees, at least 65 degrees, at least 70 degrees, at least 75 degrees, at least 80 degrees, at least 85 degrees, at least 90 degrees, or any other suitable value or range therebetween.
- the wall 112, or more specifically a microporous material thereof may transition from a hydrophobic state to a hydrophilic state, and the speed or rate of this transition can be measured using this method.
Landscapes
- Health & Medical Sciences (AREA)
- Ophthalmology & Optometry (AREA)
- Heart & Thoracic Surgery (AREA)
- Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- External Artificial Organs (AREA)
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU2022380562A AU2022380562A1 (en) | 2021-11-05 | 2022-11-04 | Fluid drainage devices, systems, and methods |
CN202280073792.8A CN118201571A (en) | 2021-11-05 | 2022-11-04 | Fluid drainage devices, systems, and methods |
CA3234586A CA3234586A1 (en) | 2021-11-05 | 2022-11-04 | Fluid drainage devices, systems, and methods |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US202163276183P | 2021-11-05 | 2021-11-05 | |
US63/276,183 | 2021-11-05 | ||
US17/980,431 | 2022-11-03 | ||
US17/980,431 US20230142430A1 (en) | 2021-11-05 | 2022-11-03 | Fluid drainage devices, systems, and methods |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2023081365A1 true WO2023081365A1 (en) | 2023-05-11 |
Family
ID=84519862
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2022/048971 WO2023081365A1 (en) | 2021-11-05 | 2022-11-04 | Fluid drainage devices, systems, and methods |
Country Status (1)
Country | Link |
---|---|
WO (1) | WO2023081365A1 (en) |
Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9375347B2 (en) * | 2007-11-23 | 2016-06-28 | Ecole Polytechnique Federale De Lausanne (Epfl) | Non-invasively adjustable drainage device |
US20180263817A1 (en) * | 2017-03-17 | 2018-09-20 | W. L. Gore & Associates, Inc. | Integrated aqueous shunt for glaucoma treatment |
US20190167475A1 (en) * | 2013-02-19 | 2019-06-06 | Aquesys, Inc. | Adjustable intraocular implant |
US20200337897A1 (en) * | 2017-11-21 | 2020-10-29 | Forsight Vision4, Inc. | Fluid exchange apparatus for expandable port delivery system and methods of use |
EP3773377A1 (en) * | 2018-04-03 | 2021-02-17 | Jack Chu | A new ocular device and method for glaucoma treatment |
AU2017439185B2 (en) * | 2017-11-08 | 2021-05-13 | Aquesys, Inc. | Manually adjustable intraocular flow regulation |
-
2022
- 2022-11-04 WO PCT/US2022/048971 patent/WO2023081365A1/en active Application Filing
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9375347B2 (en) * | 2007-11-23 | 2016-06-28 | Ecole Polytechnique Federale De Lausanne (Epfl) | Non-invasively adjustable drainage device |
US20190167475A1 (en) * | 2013-02-19 | 2019-06-06 | Aquesys, Inc. | Adjustable intraocular implant |
US20180263817A1 (en) * | 2017-03-17 | 2018-09-20 | W. L. Gore & Associates, Inc. | Integrated aqueous shunt for glaucoma treatment |
AU2017439185B2 (en) * | 2017-11-08 | 2021-05-13 | Aquesys, Inc. | Manually adjustable intraocular flow regulation |
US20200337897A1 (en) * | 2017-11-21 | 2020-10-29 | Forsight Vision4, Inc. | Fluid exchange apparatus for expandable port delivery system and methods of use |
EP3773377A1 (en) * | 2018-04-03 | 2021-02-17 | Jack Chu | A new ocular device and method for glaucoma treatment |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
JP7458446B2 (en) | Integrated aqueous shunt for glaucoma treatment | |
JP4977758B2 (en) | Microfluidic valve having free floating member and method of manufacturing the same | |
US8585630B2 (en) | Implantable intraocular pressure drain | |
JP2023083326A (en) | Ocular drainage system devices and methods | |
US20230142430A1 (en) | Fluid drainage devices, systems, and methods | |
WO2023081365A1 (en) | Fluid drainage devices, systems, and methods | |
US20230142433A1 (en) | Fluid drainage devices, systems, and methods | |
WO2023081356A1 (en) | Fluid drainage devices, systems, and methods | |
KR20240097927A (en) | Fluid discharge devices, systems and methods | |
US20240065891A1 (en) | Biological fluid drainage devices and methods | |
WO2024044300A1 (en) | Biological fluid drainage devices and methods | |
KR20240097928A (en) | Fluid discharge devices, systems and methods | |
US20230218286A1 (en) | Biological fluid drainage devices, systems, and methos | |
US20230310211A1 (en) | Biological fluid shunt devices and methods | |
AU2023207083A1 (en) | Biological fluid drainage devices, systems, and methods |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 22823187 Country of ref document: EP Kind code of ref document: A1 |
|
WWE | Wipo information: entry into national phase |
Ref document number: 3234586 Country of ref document: CA |
|
WWE | Wipo information: entry into national phase |
Ref document number: AU2022380562 Country of ref document: AU |
|
ENP | Entry into the national phase |
Ref document number: 2022380562 Country of ref document: AU Date of ref document: 20221104 Kind code of ref document: A |
|
WWE | Wipo information: entry into national phase |
Ref document number: 2022823187 Country of ref document: EP |
|
ENP | Entry into the national phase |
Ref document number: 2022823187 Country of ref document: EP Effective date: 20240605 |