Delivery aids for glaucoma shunts.
Abstract
Glaucoma treatment systems are described. In various examples, glaucoma treatment systems include a fluid body and conduit configured to facilitate evacuation of fluid, such as aqueous humor, from a fluid-filled body cavity, such as the anterior chamber of an eye. In some examples, the fluid conduit is soft and compliant, and the glaucoma treatment system includes one or more reinforcing members coupled with the fluid conduit to temporarily reinforce the fluid conduit and aid delivery of the glaucoma treatment device. glaucoma. In some examples, the stiffening members can be removed from the fluid conduit after the glaucoma treatment system has been implanted.

Term
11.5 yearsleft in the term
Expires 16 March 2038.
- Priority
- Filed
- Granted
- Today
- Expires
25 claims: 16 independent, 9 dependent
- 1REIVINDICACIONES 1. Un sistema biológico de drenaje de fluidos, caracterizado porque comprende:un cuerpo;un conducto de fluido flexible acoplado de manera fluida al cuerpo y que incluye un primer extremo, un segundo extremo y una luz, en donde el primer extremo se puede colocar dentro de una cavidad corporal llena de fluido de un tejido biológico, y el segundo extremo se puede colocar fuera de la cavidad corporal llena de fluido de tal manera que un fluido de la cavidad corporal llena de fluido es transferible a través de la luz del conducto de fluido al cuerpo;un miembro de refuerzo acoplado de manera extraíble con el conducto de fluido, en donde el miembro de refuerzo está colocado dentro de la luz y se extiende a lo largo del conducto de fluido.
- 2El sistema de conformidad con la reivindicación 1, caracterizado porque el miembro de refuerzo y el conducto de fluido, en combinación, forman un conjunto, en donde uno de una resistencia de columna, una rigidez lateral y una resistencia del aro del conjunto excede la resistencia de columna, la rigidez lateral y la resistencia del aro del conducto de fluido, respectivamente.
- 3El sistema de conformidad con cualquiera de las reivindicaciones anteriores, caracterizado porque un extremo del miembro de refuerzo se extiende desde uno del primero y segundo extremos del conducto de fluido de modo que el extremo del miembro de refuerzo sea accesible durante un procedimiento de implantación.
- 4El sistema de conformidad con cualquiera de las reivindicaciones anteriores, caracterizado porque el miembro de refuerzo forma una bobina dentro de la luz del conducto de fluido.
- 5El sistema de conformidad con la reivindicación 4, caracterizado porque el miembro de refuerzo está configurado para desenredarse tras una aplicación de tensión a uno del primero y segundo extremos del miembro de refuerzo.
- 6El sistema de conformidad con cualquiera de las reivindicaciones anteriores, caracterizado porque el miembro de refuerzo es un primer miembro de refuerzo, el sistema comprende adicionalmente un segundo miembro de refuerzo acoplado de manera desmontable con el conducto de fluido, en donde el segundo miembro de refuerzo se extiende a través de una pared lateral del conducto de fluido de modo que una primera porción del segundo miembro de refuerzo se extiende dentro de la luz del tubo y tal que una segunda porción del segundo miembro de refuerzo se extiende exterior al tubo a lo largo de la pared 63 lateral del tubo, en donde la segunda porción del segundo miembro de refuerzo es accesible durante un procedimiento de implantación.
- 7El sistema de conformidad con la reivindicación 6, caracterizado porque un segundo extremo del segundo miembro de refuerzo se extiende desde uno del primero y segundo extremos del conducto de fluido de modo que el segundo extremo del miembro de refuerzo sea accesible durante un procedimiento de implantación.
- 8El sistema de conformidad con cualquiera de las reivindicaciones anteriores, caracterizado porque el conducto de fluido comprende politetrafluoroetileno expandido.
- 9El sistema de conformidad con cualquiera de las reivindicaciones anteriores, caracterizado porque la cavidad corporal llena de líquido es una cámara anterior de un ojo y el líquido es humor acuoso, y en donde el sistema de drenaje biológico de fluido está configurado para regular la presión infraocular del ojo de un paciente cuando se implanta.
- 10Un sistema biológico de drenaje de fluidos, caracterizado porque comprende:un conducto de fluido flexible que tiene un primer extremo y un segundo extremo, y que define un lumen, en donde el primer extremo se puede colocar dentro de una cavidad corporal llena de fluido de un tejido biológico, y el segundo extremo se puede colocar fuera del depósito de tejido biológico de manera que el fluido de la cavidad corporal llena de fluido es transferidle a través de la luz del conducto de fluido a una región fuera de la cavidad corporal llena de fluido;y un miembro de refuerzo acoplado al conducto de fluido, en donde el miembro de refuerzo está colocado dentro de la luz del conducto de fluido y extiende una longitud del conducto de fluido de manera que el miembro de refuerzo y el conducto de fluido, en combinación, formen un conjunto, y en donde una resistencia de columna del conjunto excede la resistencia de columna del conducto de fluido.
- 11El sistema de conformidad con la reivindicación 10, caracterizado porque comprende adicionalmente un cuerpo microporoso acoplado de forma fluida con el conducto de fluido, en donde el segundo extremo del conducto de fluido está colocado dentro del cuerpo microporoso.
- 12El sistema de conformidad con cualquiera de las reivindicaciones 10 a 11, caracterizado porque el miembro de refuerzo está acoplado de manera extraíble al conducto de fluido.
- 13El sistema de conformidad con cualquiera de las reivindicaciones 10 a 12, caracterizado porque el miembro de refuerzo es un primer miembro de refuerzo, el sistema comprende adicionalmente un segundo miembro de refuerzo acoplado de manera desmontable con el conducto de fluido, en donde el segundo miembro de refuerzo se extiende a través de una pared lateral del conducto de fluido de modo que una primera porción del segundo miembro de refuerzo se extiende dentro de la luz del tubo y tal que una segunda porción del segundo miembro de refuerzo se extiende exterior al tubo a lo largo de la pared lateral del tubo, en donde la segunda porción del segundo miembro de refuerzo es accesible durante un procedimiento de implantación.
- 14El sistema de conformidad con la reivindicación 13, caracterizado porque un segundo extremo del segundo miembro de refuerzo se extiende desde uno del primero y segundo extremos del conducto de fluido de modo que el segundo extremo del miembro de refuerzo sea accesible durante un procedimiento de implantación.
- 15El sistema de conformidad con cualquiera de las reivindicaciones 10 a 14, caracterizado porque el conducto de fluido comprende politetrafluoroetileno expandido.
- 16El sistema de conformidad con cualquiera de las reivindicaciones 10 a 15, caracterizado porque la cavidad corporal llena de líquido es una cámara anterior de un ojo y el líquido es humor acuoso, y en donde el sistema de drenaje biológico de fluido está configurado para regular la presión infraocular del ojo de un paciente cuando se implanta.
- 17Un método caracterizado porque comprende:proporcionar un tubo que tiene una luz que se extiende a través del mismo;acoplar el tubo a un cuerpo de manera que la luz del tubo esté acoplada de manera fluida al cuerpo;y disponer un miembro de refuerzo dentro de la luz del tubo de modo que el miembro de refuerzo se pueda retirar de la luz del tubo y de manera que el miembro de refuerzo y el tubo, en combinación, formen un conjunto, y en donde la resistencia de columna del conjunto exceda una resistencia de columna del tubo.
- 18El método de conformidad con cualquiera de las reivindicaciones 17, caracterizado porque una rigidez lateral del conjunto excede una rigidez lateral del tubo, y una resistencia del aro del conjunto excede una resistencia del aro del tubo.
- 19El método de conformidad con cualquiera de las reivindicaciones 17 a 18, caracterizado porque disponer un miembro de refuerzo dentro de la luz del tubo incluye:enrollar un elemento alargado alrededor de un mandril para formar una bobina alrededor del mandril;formar un tubo alrededor del elemento alargado enrollado, de manera que el elemento alargado enrollado esté dispuesto dentro de una luz del tubo y de manera que el elemento alargado enrollado se pueda retirar de la luz del tubo;y retirar el mandril de manera que el elemento alargado permanezca enrollado dentro de la luz del tubo.
- 20El método de conformidad con la reivindicación 19, caracterizado porque formar el tubo alrededor del elemento alargado enrollado incluye envolver una película alrededor del elemento alargado enrollado.
- 21El método de conformidad con la reivindicación 20, caracterizado porque la película es una cinta.
- 22El método de conformidad con cualquiera de las reivindicaciones 19 a 21, caracterizado porque el elemento alargado es una fibra, en donde una de la película y la fibra es un fluoropolímero.
- 23El método de conformidad con la reivindicación 22, caracterizado porque el fluoropolímero es politetrafluoroetileno expandido.
- 24El método de conformidad con cualquiera de las reivindicaciones 17 a 23, caracterizado porque el miembro de refuerzo es un primer miembro de refuerzo, en donde el método comprende adicionalmente disponer un segundo miembro de refuerzo dentro de la luz del tubo de modo que el segundo miembro de refuerzo se extiende a través de una pared lateral del tubo, de modo que una primera porción del segundo miembro de refuerzo se extiende dentro de la luz del tubo y tal que una segunda porción del segundo miembro de refuerzo se extiende exterior al tubo a lo largo de la pared lateral del tubo, en donde la segunda porción del segundo miembro de refuerzo es accesible durante un procedimiento de implantación.
- 25El método de conformidad con la reivindicación 24, caracterizado porque el primer y el segundo miembros de refuerzo se pueden retirar independientemente de la luz del tubo.
Independent claims25
230 paragraphs in 5 sections, as filed
ADMINISTRATIVE ASSISTANTS FOR GLAUCOMA REFERRALS
BACKGROUND OF THE INVENTION
Aqueous humor is a fluid that fills the anterior chambers of the eye and contributes to the infraocular pressure or the pressure of the fluid within the eye. Glaucoma is a progressive eye disease characterized by increased infraocular pressure in the eye. This increase in infraocular pressure is commonly caused by an insufficient amount of aqueous humor reabsorbed by the body. In some cases, the aqueous humor is not absorbed fast enough or even at all, while in other cases, the aqueous humor is additionally or alternatively produced too quickly. An increase in infraocular pressure is associated with a gradual and sometimes permanent loss of vision in the affected eye.
Various attempts have been made to treat glaucoma. However, some of the conventional devices lack the flexibility, compliance, and device / tissue bond that is required to prevent relative movement between the device and the surrounding tissue. Such movement can lead to persistent irritation of the surrounding tissue. The irritation, in turn, can lead to an increased response from chronic inflammatory tissue, excessive scarring at the device site, and an increased risk of device erosion through the conjunctiva and endophthalmitis. In cases where erosion does not occur, scar tissue effectively prevents the reabsorption of aqueous humor. These complications can help prevent the correct functioning of the device. The resulting effect is a gradual increase in infraocular pressure and the progression of glaucoma.
BRIEF DESCRIPTION OF THE INVENTION
According to one example, ("Example 1"), a biological fluid drainage system includes a body; a flexible fluid conduit fluidly coupled to the body and including a first end, a second end, and a lumen, wherein the first end can be positioned within a fluid-filled body cavity of a biological tissue, and the second end it can be positioned outside the fluid-filled body cavity such that a fluid from the fluid-filled body cavity is transferred through the lumen of the fluid conduit to the body; and a stiffening member removably coupled to the fluid conduit, wherein the stiffening member is positioned within the lumen and extends along the fluid conduit.
According to another example, ("Example 2") additional to Example 1, the reinforcing member and the fluid conduit, in combination, form an assembly, wherein one of a column resistance, a lateral stiffness and a resistance of the assembly ring exceeds column strength, lateral stiffness, and fluid conduit ring strength, respectively.
According to another example, ("Example 3") in addition to either of Examples 1 and 2, one end of the reinforcing member extends from one of the first and second ends of the fluid conduit so that the end of the reinforcing member be accessible during an implantation procedure.
According to another example, ("Example 4") in addition to any of the previous Examples, the reinforcing member forms a coil within the lumen of the fluid conduit.
According to another example, ("Example 5") in addition to Example 4, the reinforcing member is configured to unravel upon application of tension to one of the first and second ends of the reinforcing member.
According to another example, ("Example 6") in addition to any of the previous Examples, the reinforcing member is a first reinforcing member, the system further comprises a second reinforcing member removably coupled to the fluid conduit, wherein the second reinforcement member extends through a side wall of the fluid conduit such that a first portion of the second reinforcement member extends into the lumen of the tube and such that a second portion of the second reinforcement member extends extends outside the tube along the side wall of the tube, where the second portion of the second reinforcing member is accessible during an implantation procedure.
According to another example, ("Example 7") in addition to Example 6, a second end of the second reinforcing member extends from one of the first and second ends of the fluid conduit so that the second end of the reinforcing member is accessible during an implantation procedure.
According to another example, ("Example 8") in addition to any of the previous Examples, the fluid conduit comprises expanded polytetrafluoroethylene.
According to another example, ("Example 9") in addition to any of the previous Examples, the fluid-filled body cavity is an anterior chamber of an eye and the fluid is aqueous humor, wherein the biological fluid drainage system is configured to regulate an infraocular pressure of a patient's eye when implanted.
According to another example, ("Example 10") in addition to any of the previous Examples, an axial length of the reinforcing member is configured to increase upon application of tension to the reinforcing member independent of the fluid conduit.
According to another example, ("Example 11") a biological fluid drainage system includes a compatible fluid conduit having a first end and a second end, and defining a lumen, the first end being positionable within a cavity body filled with biological fluid from a tissue, and the second end is positionable outside the tissue reservoir
Biological LZQrnn / nznz / q / Yi such that a fluid from the fluid-filled body cavity is transferred through the lumen of the fluid conduit to a region outside the fluid-filled body cavity; and a stiffening member coupled to the fluid conduit, wherein the stiffening member is positioned within the lumen of the fluid conduit and extends a length of the fluid conduit such that the stiffening member and the fluid conduit, in combination, form an assembly, and wherein a resistance of the column of the assembly exceeds the resistance of the column of the fluid conduit.
According to another example, ("Example 12") in addition to Example 11, the system further includes a microporous body fluidly coupled to the fluid conduit, wherein the second end of the fluid conduit is positioned within the microporous body.
According to another example, ("Example 13") in addition to any of Examples 11 to 12, the reinforcing member is removably coupled to the fluid conduit.
According to another example, ("Example 14") in addition to any of Examples 11 to 13, the reinforcing member is a first reinforcing member, the system further comprises a second reinforcing member removably coupled with the conduit of fluid, wherein the second reinforcement member extends through a side wall of the fluid conduit such that a first portion of the second reinforcement member extends into the lumen of the tube and such that a second portion of the second reinforcement member extends extends outside the tube along the side wall of the tube, where the second portion of the second reinforcing member is accessible during an implantation procedure.
According to another example, ("Example 15") in addition to Example 14, a second end of the second reinforcing member extends from one of the first and second ends of the fluid conduit so that the second end of the reinforcing member is accessible during an implantation procedure.
According to another example, ("Example 16") in addition to any of Examples 11 to 15, the fluid conduit comprises expanded polytetrafluoroethylene.
According to another example, ("Example 17") in addition to any of Examples 11 to 16, the fluid-filled body cavity is an anterior chamber of an eye and the fluid is aqueous humor, wherein the fluid drainage system Biological is configured to regulate the infraocular pressure of the patient's eye when implanted.
According to another example, ("Example 18") one method includes providing a tube having a lumen extending through it; coupling the tube to a body such that the tube lumen is fluidly coupled to the body; and arranging a reinforcing member within the tube lumen such that the reinforcing member can be removed from the tube lumen and such that the reinforcing member and the tube, in combination, form an assembly, and wherein the resistance column of the assembly exceeds a column resistance of the tube.
According to another example, ("Example 19") in addition to Example 18, a lateral stiffness of the assembly exceeds a lateral stiffness of the tube, and a resistance of the ring of the assembly exceeds a resistance of the tube ring.
According to another example, ("Example 20") in addition to any of Examples 18 to 19, arranging a reinforcing member within the tube lumen includes wrapping an elongated member around a mandrel to form a coil around the mandrel; forming a tube around the rolled elongated member so that the rolled elongated member is disposed within a tube lumen and such that the rolled elongated member can be removed from the tube lumen; and withdrawing the mandrel so that the elongated element remains coiled within the tube lumen.
According to another example, ("Example 21") in addition to Example 20, forming the tube around the rolled elongated member includes wrapping a film around the rolled elongated member.
According to another example, ("Example 22") additional to Example 21, the film is a tape.
According to another example, ("Example 23") in addition to any of Examples 20 to 22, the elongated element is a fiber, wherein one of the film and the fiber is a fluoropolymer.
According to another example, ("Example 24") additional to Example 23, the fluoropolymer is expanded polytetrafluoroethylene.
According to another example, ("Example 25") in addition to any of Examples 18 to 24, the reinforcing member is a first reinforcing member, and the method further includes disposing a second reinforcing member within the tube lumen. so that the second reinforcing member extends through a side wall of the tube, such that a first portion of the second reinforcing member extends into the lumen of the tube and such that a second portion of the second reinforcing member extends outside the tube along the side wall of the tube, wherein the second portion of the second reinforcing member is accessible during an implantation procedure.
According to another example ("Example 26") in addition to Example 25, the first and second reinforcing members can be removed independently of the tube lumen.
According to another example, ("Example 27") one method includes winding an elongated element around a mandrel to form a coil around the mandrel; forming a tube around the rolled elongated member so that the rolled elongated member is disposed within a tube lumen and such that the rolled elongated member can be removed from the tube lumen; and removing the mandrel without removing the elongated member from the tube lumen so that the elongated member defines a reinforcing member.
According to another example, ("Example 28") additional to Example 27, the elongated element is a fiber.
According to another example, ("Example 29") in addition to any of Examples 27 to 28, forming the tube around the rolled elongated member includes wrapping a film around the rolled elongated member.
According to another example, ("Example 30") additional to Example 29, the film is a tape.
According to another example, ("Example 31") in addition to Example 30, the film is a membrane.
According to another example, ("Example 32") in addition to any of Examples 29 to 31, one of the film and fiber is a fluoropolymer.
According to another example, ("Example 33") additional to Example 32, the fluoropolymer is expanded polytetrafluoroethylene.
According to another example, ("Example 34") in addition to any of Examples 27 to 33, the method further includes coupling the tube to a microporous body such that the lumen of the tube is fluidly coupled to the microporous body, wherein the reinforcing member extends into an interior of the microporous body.
According to another example, ("Example 35") in addition to any of Examples 27 to 34, the reinforcing member is a first reinforcing member, wherein the method further comprises disposing a second reinforcing member within the lumen of the tube such that a first end of the second reinforcement member extends through a side wall of the tube and such that the second reinforcement member can be removed from the lumen of the tube.
According to another example, ("Example 36") in addition to Example 35, arranging a second reinforcing member within the tube lumen includes inserting the second reinforcing member into the tube lumen after the tube is formed. , so that the second reinforcing member pierces the side wall of the tube.
According to another example, ("Example 37") in addition to any of Examples 35 to 36, the first and second reinforcing members can be removed independently of the tube lumen.
According to another example, ("Example 38") one method includes providing a tube having a first end, a second end, and a lumen extending from the first end to the second end, wherein a first reinforcing member is extends into the lumen of the tube such that the reinforcing member and the tube, in combination, form a tubular assembly, and wherein at least one of the column strengths of the tubular assembly exceeds the column strength of the tube, a lateral stiffness of the tubular assembly exceeds a lateral stiffness of the tube, and the resistance of the ring of the tubular assembly exceeds the resistance of the ring of the tube; securing a position of the first end of the tube; advancing the second end of the tube to a position within a reservoir of biological tissue fluid; and removing the first reinforcing member from the tube so that the tube functions as a fluid conduit for fluid egress into the biological tissue fluid reservoir.
According to another example, ("Example 39") in addition to Example 38, the tube further comprises a second reinforcing member that extends into the lumen of the tube, the second reinforcing member extending through a side wall of the tube. tube, The method further comprises piercing the biological tissue with one end of the second reinforcing member and advancing the second reinforcing member and the second end of the tube until the second end of the tube advances into position within the fluid reservoir.
According to another example, ("Example 40") in addition to any of Examples 38 to 39, securing the position of the first end of the tube includes placing the first end of the tube between the tissue layers of a patient's eye, wherein the fluid is aqueous humor within an anterior chamber of the patient's eye.
BRIEF DESCRIPTION OF THE DRAWINGS
The accompanying drawings are included to provide a better understanding of the embodiments of the description, and are incorporated into and constitute a part of this specification, illustrate examples and, together with the description, serve to explain the principles of the specification.
Figure 1 is an illustration of a glaucoma drainage system consistent with various aspects of the present disclosure.
Figure 2A is an illustration of a glaucoma drainage system in a deflated state consistent with various aspects of the present disclosure.
Figure 2B is an illustration of a glaucoma drainage system in an inflated state consistent with various aspects of the present disclosure.
Figure 3 is an exploded view of the glaucoma drainage system illustrated in Figure 2.
Figure 4A, Figure 4B, Figure 4C and Figure 4D are illustrations of interface surfaces of the constriction diffusion membrane consistent with various aspects of the present disclosure.
Figure 5 is an illustration of a glaucoma drainage system consistent with various aspects of the present disclosure.
Figure 6 is an illustration of a glaucoma drainage system consistent with various aspects of the present disclosure.
Figure 7A is an illustration of a glaucoma drainage system in a deflated state consistent with various aspects of the present disclosure.
Figure 7B is an illustration of a glaucoma drainage system in an inflated state consistent with various aspects of the present disclosure.
Figure 8 is an illustration of a fluid conduit consistent with various aspects of the present disclosure.
Figure 9A is an illustration of a glaucoma drainage system consistent with various aspects of the present disclosure.
Figure 9B is a detailed view of a region 9B of the glaucoma drainage system of Figure 9A, but not in cross section.
Figure 90 is an illustration of a glaucoma drainage system consistent with various aspects of the present disclosure.
Figure 9D is an illustration of a glaucoma drainage system consistent with various aspects of the present disclosure.
Figure 10A is an illustration of a glaucoma drainage device consistent with various aspects of the present disclosure.
Figure 10B is a cross-sectional view of the glaucoma drainage system of Figure 9A taken along line 10B-10B.
Figure 10C is a cross-sectional view of the glaucoma drainage system of Figure 9A taken along line 10C-10C.
Figure 11 is an exploded view of a glaucoma drainage system consistent with various aspects of the present disclosure.
Figure 12 is an illustration of a glaucoma drainage system implanted within ocular tissue consistent with various aspects of the present disclosure.
Figure 13 is an illustration of a glaucoma drainage system implanted within ocular tissue consistent with various aspects of the present disclosure.
While multiple embodiments are described, still other embodiments will be apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be considered illustrative and not restrictive.
DETAILED DESCRIPTION OF THE INVENTION
Those skilled in the art will readily understand that the various embodiments of the inventive concepts provided in the present description can be accomplished by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying figures referenced herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present description, and, in that sense, the figures should not be interpreted as limiting. As used herein, the term "diffusion membranes" is intended to encompass one or more proliferation diffusion membranes and / or one or more constriction diffusion membranes.
Various aspects of the present disclosure relate to glaucoma drainage devices, drainage systems, and drainage methods. More specifically, the present disclosure relates to devices, systems, and methods for draining aqueous humor from the anterior chamber of a patient's eye so that it can be reabsorbed by the body. Providing a mechanism for the reabsorption of aqueous humor that has been evacuated from the anterior chamber of the eye works to lower or stabilize intraocular pressure.
A glaucoma drainage system 1000 according to some modalities is illustrated in Figure 1. The Glaucoma Drainage System 1000 is an implantable medical system that functions to facilitate the drainage of a fluid, such as aqueous humor, from a fluid-filled body cavity, such as the anterior chamber of the eye. The glaucoma drainage system 1000 includes a fluid conduit 1500 and a body, such as an aqueous humor diffusion member 1002. While the following description refers to a glaucoma drainage system 1000 for use in draining aqueous humor from the anterior chamber of the eye, one of skill in the art should understand and understand that the depicted glaucoma drainage system 1000 is can be set up and used to evacuate other fluids from other fluid filled body chambers. In some examples, as explained in more detail below, the Glaucoma Drainage System 1000 also helps facilitate the reabsorption of fluid evacuated from the body. For example, in some embodiments, the glaucoma drainage system 1000 provides an interface between the evacuated aqueous humor and tissues, vessels, and / or cells that have the ability to absorb the aqueous humor and are sufficiently close to the glaucoma drainage system. 1000 to interact with the evacuated aqueous humor. Thus, in some examples, the aqueous humor evacuated from the anterior chamber of the eye travels through the glaucoma drainage system 1000 before being reabsorbed by the body.
In some embodiments, when the glaucoma drainage system 1000 is implanted, the aqueous humor is evacuated from the anterior chamber through the fluid conduit 1500. The subsequently evacuated aqueous humor enters a reservoir of the aqueous humor diffusion member 1002 and it is filtered through one or more porous membranes of the aqueous humor diffusion member 1002, where the aqueous humor can be reabsorbed by the body. In various embodiments, in addition to permeability to aqueous humor, inward tissue growth is allowed or promoted along one or more regions of the glaucoma drainage system 1000. For example, the exterior of the aqueous humor diffusion member 1002 may include or be defined by one or more membranes that are porous or permeable to the fluid of the fluid-filled body cavity (hereinafter referred to as diffusion membranes), and that are configured to allow or promote growth into the tissue. Allowing tissue inward growth along surfaces or within regions of the Glaucoma Drainage System 1000 helps facilitate biointegration of the Glaucoma Drainage System 1000 into the surrounding tissue (e.g. eye tissue), and helps to facilitate the reabsorption of the evacuated aqueous humor by the surrounding tissue. Additionally, biointegration, which includes tissue ingrowth and fixation, helps minimize relative movement between the Glaucoma Drainage System 1000 and the tissue surrounding the Glaucoma Drainage System 1000, helping to prevent irritation of ocular tissue that can cause a tissue response to foreign body, scar formation and / or erosion and infection of the site of the glaucoma drainage system 1000.
In some examples, as discussed in greater detail below, the fluid conduit of the glaucoma drainage system 1000 is a soft and flexible biocompatible tubular structure. Accordingly, in some examples, the glaucoma drainage system 1000 further includes a reinforcing member that is removably integrated with the fluid conduit 1500, which aids in the administration / implantation of the glaucoma drainage system 1000. That is, in some examples, the glaucoma drainage system 1000 includes a removable component (eg, a reinforcing member) to provide temporary stiffness to the fluid passage, helping clinicians manipulate the fluid passage. and / or the body of the glaucoma drainage system. Such a configuration provides a Glaucoma Drainage System 1000 that is flexible and can be operated to conform to the tissue (e.g., eye tissue) and the profile of the anatomy where the Glaucoma Drainage System 1000 is implanted, while maintaining a profile. minimal to avoid irritation and / or interference with normal body functions (e.g. blinking of the eye) while being easily implanted, as such soft and flexible structures would otherwise be difficult to properly manipulate and orient within the anatomy.
In various embodiments, the aqueous humor diffusion member 1002 includes an interior region that defines a reservoir for aqueous humor that is evacuated from the anterior chamber through the fluid conduit 1500. The interior region of the aqueous humor diffusion member 1002 it may include one or more membranes that are porous or permeable to the fluid of the fluid-filled body cavity (hereinafter referred to as diffusion membranes). For example, as discussed in greater detail below, one or more of the diffusion membranes may be formed of a porous medium, such as a polymeric material, that has a microstructure that is suitable for transporting fluid through a porous space. of the porous medium. Thus, in some embodiments, the reservoir may be defined by the pore space of one or more of the diffusion membranes that form the aqueous humor diffusion member 1002. In some embodiments, the aqueous humor diffusion member 1002 can be configured so that the reservoir is additionally or alternatively defined between two or more of the diffusion membranes that form the aqueous humor diffusion member 1002. For example, in some embodiments, at least a portion of the surface areas between the adjacently located diffusion membranes that form the aqueous humor diffusion member 1002 remains unbonded or unbonded, such that the diffusion membranes adjacently located can be operated to separate from each other along at least a portion of their surface areas to form and define the reservoir. In some embodiments, as noted below, the reservoir defined between the adjacently located diffusion membranes can be operated to inflate or expand in a controlled manner (for example, to a predetermined profile when inflated) so that the drainage system Glaucoma 1000 does not interfere with normal eye function (eg, regular eye movement, including pivoting and blinking).
In various embodiments, the aqueous humor diffusion member 1002 is sized and shaped so that it can be implanted within the anatomy of the patient. For example, in some embodiments, aqueous humor diffusion member 1002 is sized and shaped so that it can be implanted within a dissected subconjunctival space (eg, between a sclera and a conjunctiva of the patient's eye). In some embodiments, the aqueous humor diffusion member 1002 is a thin, circular member. In some embodiments, the aqueous humor diffusion member 1002 has a thickness (for example, a distance measured between the first outer surface 1004 and the second outer surface 1006) less than or equal to half a millimeter (0.5 mm), such as between one tenth of a millimeter (0.1 mm) and half a millimeter (0.5 mm). However, given the different anatomies of the human body, an aqueous humor diffusion member 1002 may exceed half a millimeter (0.5 mm), as long as the thickness does not substantially interfere with the normal function of the eye (for example, pivot and blink) or substantially reduce flexibility of the aqueous humor diffusion member 1002 to the extent that undesirable relative movement occurs between the glaucoma drainage system 1000 and the surrounding tissue when implanted, causing a likely consequence of tissue irritation, tissue response to foreign body and / or excessive scarring.
In some embodiments, the aqueous humor diffusion member 1002 can have a diameter in the range of five (5) millimeters to fifteen (15) millimeters, such as, for example, ten (10) millimeters. In some embodiments, the aqueous humor diffusion member 1002 may be ovular and include a major dimension (eg, along a major axis of the ellipse) of up to about thirty (30) millimeters and the corresponding minor dimension (for example, along a major axis of the ellipse) of up to approximately ten (10) millimeters. As mentioned above, given the different anatomies of the human body, an aqueous humor diffusion member 1002 may exceed such dimensions (e.g., fifteen (15), ten (10) and thirty (30) millimeters) as long as the size does not substantially interferes with the normal functioning of the eyes (e.g., rolling and blinking) or substantially reduces the flexibility of the aqueous humor diffusing member, by causing undesirable relative movement between the glaucoma drainage system 1000 and surrounding tissue when implanted, it is caused by a likely consequence of tissue irritation, tissue response to foreign body, and / or excessive scarring. Similarly, the aqueous humor diffusion member 1002 may have a diameter less than five (5) millimeters, three (3) millimeters, or even less than three (3) millimeters, as long as the aqueous humor diffusion member 1002 can operated to accommodate a sufficient degree of evacuated aqueous humor and may be operated to facilitate reabsorption of aqueous humor to constitute an effective treatment for the patient.
In various embodiments, the fluid conduit 1500 functions to fluidly couple the reservoir with the fluid-filled body cavity (eg, the anterior chamber of the eye) when implanted in the body so that a differential pressure can be achieved. between the reservoir and the environment outside the glaucoma drainage system 1000 (eg atmosphere). Therefore, when implanted, it should be understood that the pressure within the reservoir is based, at least in part, on the pressure within the fluid-filled body cavity (eg, the infraocular pressure of the anterior chamber of the eye). In some embodiments, such differential pressure causes the reservoir to inflate or expand. Furthermore, in some embodiments, such differential pressure causes aqueous humor to leak through the diffusion membranes of aqueous humor diffusion member 1002. That is, in some embodiments, the evacuated aqueous humor enters the reservoir and is filtered through through the diffusion membranes of the aqueous humor diffusion member 1002, where the aqueous humor can be reabsorbed by the body.
Turning to Figure 2A and Figure 2B, a glaucoma drainage system 1000 is shown including an aqueous humor diffusion member 1002 comprised of a plurality of diffusion membranes. The aqueous humor diffusion member 1002 includes a first outer surface 1004, a second outer surface 1006 opposite the first outer surface 1004, and a periphery 1008. Figure 2A shows the glaucoma drainage system 1000 in a deflated state. Figure 2B shows the glaucoma drainage system 1000 in an inflated state, where aqueous humor is present within an inflexible or expandable reservoir 1010. Whereas the glaucoma drainage system 1000 is shown in Figure 2B in an inflated state where the glaucoma drainage system 1000 is not inflated uniformly (for example, the first proliferation and constriction diffusion membranes 1100 and 1200 are shown adopting a generally non-linear configuration, while the second proliferation and constriction diffusion membranes 1300 and 1400 are shown in a generally linear configuration), It should be understood that the glaucoma drainage system 1000 may deform uniformly (for example, the second proliferation and constriction diffusion membranes 1300 and 1400 may deform in a manner that reflects the deformation of the first constriction and constriction diffusion membranes 1100 and 1200). The aqueous humor diffusion member 1002 includes a body defined by a plurality of diffusion membranes including the first and second proliferation diffusion membranes 1100 and 1400, and the first and second constriction diffusion membranes 1200 and 1300. In some examples, the first and second proliferation diffusion membranes 1100 and 1400 and the first and second constriction diffusion membranes 1200 and 1300 are stacked on top of each other as shown to form the aqueous humor diffusion member 1002. As mentioned below, the first and second proliferation diffusion membranes 1100 and 1400 are configured to allow inward growth and attachment of tissue, while the first and second constriction diffusion membranes 1200 and 1300 are configured to minimize , resist or prevent tissue ingrowth and fixation.
In some embodiments, the first and second proliferation diffusion membranes 1100 and 1400 form or define an exterior of the aqueous humor diffusion member 1002, while the first and second constriction diffusion membranes 1200 and 1300 are located between the first and second proliferation diffusion membranes 1100 and 1400 and define an interior region of the aqueous humor diffusion member 1002. In various embodiments, the first and second proliferation diffusion membranes 1100 and 1400 and the first and second constriction diffusion membranes 1200 and 1300 are permeable to aqueous humor, as each is configured to allow evacuated aqueous humor (by example, aqueous humor disposed within the reservoir seal) seeps through and / or diffuses through. However, the first and second proliferation diffusion membranes 1100 and 1400 are configured to allow inward growth and fixation of tissue, while the first and second constriction diffusion membranes 1200 and 1300 are configured to minimize, resist, or prevent inward growth and fixation of tissue. A configuration of constricting diffusion membranes sandwiched or positioned between proliferating diffusion membranes as shown in Figure 2A and Figure 2B helps to minimize, for example, the ingress of bacteria that exceed the size of perforations or small holes. present in the constricting diffusion membranes and / or their migration to the anterior chamber of the eye.
In several examples, the first and second proliferation diffusion membranes 1100 and 1400 of the aqueous humor diffusion member 1002 are microporous, permeable to aqueous humor, and are configured to allow inward growth and / or attachment of vessels and tissues. In various embodiments, the first and second constricting diffusion membranes 1200 and 1300 are also microporous and permeable to aqueous humor, but are configured to resist or minimize inward growth and fixation of vessels and tissue structures. Thus, in various embodiments, aqueous humor diffusion member 1002 is formed of a plurality of distinct diffusion membranes including at least one first proliferation diffusion membrane 1100 and at least one first constriction diffusion membrane 1200.
While the glaucoma drainage system 1000 shown in Figure 2A and Figure 2B includes separate and distinct first and second proliferation diffusion membranes 1100 and 1400, it should be appreciated that the aqueous humor diffusion member 1002 can including the first proliferation diffusion membrane 1100 without also requiring a separate and distinct second proliferation diffusion membrane 1400. For example, the first proliferation diffusion membrane 1100 can be folded so that the first proliferation diffusion membrane 1100 surrounds the constriction diffusion membrane portion (e.g., the first and / or second constriction diffusion membranes 1200 and 1300) of the aqueous humor diffusion member 1002. In some such embodiments, one or more portions of the folded portion of proliferation diffusion membrane 1100 is bonded or welded to adjacent portions of the unfolded portion of proliferation diffusion membrane 1200 and / or one or more portions of the constriction diffusion membrane portion of the aqueous humor diffusion member 1002. Additionally or alternatively, while the glaucoma drainage system 1000 shown in Figure 2A and Figure 2B includes separate and distinct first and second constriction diffusion membranes 1200 and 1300, it should be appreciated that the diffusion member of Aqueous humor 1002 may include the first constriction diffusion membrane 1200 without also requiring a separate and distinct second constriction diffusion membrane 1300. For example, the first constriction diffusion membrane 1200 can be folded back on itself to form a multi-layer constriction diffusion membrane, wherein one or more portions of the folded portion of the constriction diffusion membrane 1200 are joined or welded in portions. adjacent areas of the unfolded portion of the constriction diffusion membrane 1200. In addition, a proliferation diffusion membrane 1100 may be further folded around the folded constriction diffusion membrane 1200, wherein the constriction diffusion membrane 1200 is folded back on itself with a fluid conduit 1500 positioned between the folded and unfolded portions. of the constriction diffusion membrane 1200. In some such embodiments, a reservoir may be defined between at least the folded and unfolded portions of the constricting diffusion membrane 1200.
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Figure 3 is an exploded view of the glaucoma drainage system 1000 shown in Figure 2A and Figure 2B. As shown in Figure 3, the aqueous humor diffusion member 1002 includes a body defined by a first proliferation diffusion membrane 1100, a first constriction diffusion membrane 1200, a second constriction diffusion membrane 1300, and a second proliferation diffusion membrane 1400. As shown, the various proliferation and constriction diffusion membranes each include interface surfaces and a periphery. For example, the first proliferation diffusion membrane 1100 includes a first interface surface 1102, a second interface surface 1104, and a periphery 1106. In some examples, the first interface surface 1102 of the first proliferation diffusion membrane 1100 corresponds to or defines the first outer surface 1004 of the glaucoma drainage system 1000. Additionally, as shown in Figure 3, the first diffusion membrane Constriction 1200 includes a first interface surface 1202, a second interface surface 1204, and a periphery 1206. Also, as shown in Figure 3, the second constriction diffusion membrane 1300 includes a first interface surface 1302, a second interface surface 1304, and a periphery 1306. As shown, the second proliferation diffusion membrane 1400 includes a first interface surface 1402, a second interface surface 1404, and a periphery 1406. In some examples, the second interface surface 1404 of the second proliferation diffusion membrane 1400 corresponds to or defines the second outer surface 1006 of the glaucoma drainage system 1000.
In various embodiments, the diffusion membranes (ie, proliferation diffusion membranes and constriction diffusion membranes) that form the aqueous humor diffusion member 1002 are located adjacent to each other in a stacked configuration. For example, as shown in Figure 2A, Figure 2B, and Figure 3, the first and second proliferation diffusion membranes 1100 and 1400 and the first and second constriction diffusion membranes 1200 and 1300 are located adjacent to each other at a stacked configuration, forming the first and second proliferation diffusion membranes 1100 and 1400 or otherwise defining an exterior of the aqueous humor diffusion member 1002, and wherein the first and second constriction diffusion membranes 1200 and 1300 are sandwiched or otherwise positioned between the first and second proliferation diffusion membranes 1100 and 1400. Therefore, the proliferation diffusion membranes that form the outer region of the aqueous humor diffusion member 1002 are configured to support or allow inward growth and tissue fixation, while the constriction diffusion membranes that form the interior region of the aqueous humor diffusion member 1002 is configured to minimize, resist, or preventing inward growth and attachment of tissue beyond or within a boundary or interface between the proliferating and constricting diffusion membranes.
By minimizing, resisting, or preventing ingrowth and attachment of tissue beyond or within the constricting diffusion membranes, the Glaucoma Drainage System 1000 minimizes, resists, or prevents ingrowth of tissue in the reservoir 1010, which helps maintain the performance of the Glaucoma Drainage System 1000 during and after biointegration of the same. For example, it is to be understood that minimizing, resisting, or preventing tissue ingrowth in constricting diffusion membranes, and thus reservoir 1010 operates to maintain flexibility of the glaucoma drainage system 1000, which, As stated herein, it helps to minimize relative movement between the Glaucoma Drainage System 1000 and the surrounding tissue, it helps to minimize irritation of the surrounding tissue. In particular, minimizing, resisting, or preventing tissue ingrowth on the constricting diffusion membranes helps prevent tissue proliferation across the interface between the adjacent constricting diffusion membranes and thus helps to prevent such growth into the tissue from entangling the constricting diffusion membranes. Preventing entanglement of the constricting diffusion membranes helps maintain the ability of the constricting diffusion membranes to slide and move relative to each other, helping to maintain the flexibility of the glaucoma 1000 drainage system.
In some examples, as described below, the aqueous humor diffusion membrane 1002 is configured such that the interface surfaces of the adjacent diffusion membranes face each other. In some examples, the first and second proliferation diffusion membranes 1100 and 1400 and the first and second constriction diffusion membranes 1200 and 1300 are oriented such that their peripheries align and / or are coaxial with each other. In some embodiments, one or more of the peripheries of the diffusion members that form the body of the aqueous humor diffusion member 1002 form the periphery 1008 of the aqueous humor diffusion member 1002. For example, as shown in Figure 2A and Figure 2B, the peripheries 1106, 1206, 1306 and 1406, collectively, form or define the periphery 1008 of the aqueous humor diffusion member 1002. However, it should be understood that the periphery of the aqueous humor diffusion member 1002 may be formed from less than all the peripheries of the diffusion membranes that form the body of the aqueous humor diffusion member 1002. For example, in some For example, the periphery 1008 of the aqueous humor diffusion member 1002 may be formed or defined by the peripheries 1106 and 1406 of the first and second proliferation diffusion membranes 1100 and 1400.
As mentioned above, in various embodiments, the adjacently located diffusion membranes are generally oriented such that one or more of their interface surfaces are located adjacent to an interface surface of an adjacently located diffusion membrane. That is, in various embodiments, the interface surfaces of the adjacently located diffusion membranes face each other. In the embodiment depicted in Figure 2A, Figure 2B, and Figure 3, the first proliferation diffusion membrane 1100 and the first constriction diffusion membrane 1200 are positioned adjacently such that the second interface surface 1104 of the First proliferation diffusion membrane 1100 faces the first interface surface 1202 of the first constriction diffusion membrane 1200. Similarly, as shown in Figure 2A, Figure 2B, and Figure 3, the first constriction diffusion membrane 1200 and the second constriction diffusion membrane 1300 are located adjacently so that the second constriction surface Interface 1204 of the first constriction diffusion membrane 1200 faces the first interface surface 1302 of the second constriction diffusion membrane 1300. Similarly, as shown in Figure 2A, Figure 2B, and Figure 3, the second proliferation diffusion membrane 1300 and the second constriction diffusion membrane 1400 are located adjacently so that the second surface of Interface 1304 of second constriction diffusion membrane 1300 faces the first interface surface 1402 of second proliferation diffusion membrane 1400.
Therefore, in some embodiments, stacked configurations such as those described above provide a first diffusion membrane having a first and second interface surface and a second diffusion membrane having a first and second interface surface. wherein the first and second diffusion membranes are located adjacently such that the second interface surface of the first diffusion membrane faces the first interface surface of the second diffusion membrane.
In various embodiments, the first and second proliferation diffusion membranes 1100 and 1400 and the first and second constriction diffusion membranes 1200 and 1300 may include or be formed of one or more layers or sheets of expanded polytetrafluoroethylene ("ePTFE", for or other polymers, such as, but not limited to, polyurethane, polysulfone, polyvinylidene fluoride or polyvinylidene difluoride (“PVDF”), polyhexafluoropropylene (PHFP), perfluoroalkoxy polymer (PFA), polyolefin, fluorinated ethylene propylene ("FEP"), acrylic copolymers and other suitable fluoro-copolymers. These polymers can be in sheet, woven or woven form (including single or multi-fiber yarns), or nonwoven porous forms. In some examples, one or more of the first and second proliferation diffusion membranes 1100 and 1400 and / or the first and second constriction diffusion membranes 1200 and 1300 may be formed from a plurality of layers or sheets of polymeric material. In some of these examples, the layers or sheets of polymeric material can be laminated or mechanically coupled to each other, such as by means of heat treatment and / or high pressure compression and / or adhesives and / or other lamination methods known to the skilled in the art. In some embodiments, as explained in greater detail below, the layers of polymeric material can be coupled together at discrete locations to form flush stabilizing structures that extend through the resulting proliferation and / or constricting diffusion membranes. Similarly, in some embodiments, as explained in greater detail below, the proliferating and / or constricting diffusion membranes may couple together at discrete locations to form stabilizing structures that extend through the aqueous humor diffusion member. resulting 1002. It should be understood that such stabilizing structures are operable to restrict a shape or profile of the aqueous humor diffusion member 1002 upon inflation or expansion of the reservoir 1010, as mentioned above.
In some embodiments, the layers or sheets of polymeric material that form the first and / or second proliferation diffusion membranes 1100 and 1400 and / or the first and / or second constriction diffusion membranes 1200 and 1300 may be subjected to one or more processes before or after their formation to modify their microstructure (and, therefore, their material properties) to increase or decrease a natural permeability (for example, a permeability to aqueous humor) of the polymeric material (s). In some examples, such processes include, but are not limited to, material coating processes, surface preconditioning processes, and / or drilling processes. Material coating processes can be used to at least partially fill the pore space of the polymeric material (s), thereby reducing permeability, as will be understood by those skilled in the art. Additionally or alternatively, material coating processes can be used to apply one or more drugs or antimicrobial coatings to the surface of the polymeric material (such as metal salts, including silver carbonate) and organic compounds (for example, chlorhexidine diacetate). to the polymeric material.
In some embodiments, one or both of the first and second proliferation diffusion membranes 1100 and 1400 and / or one or both of the first and second constriction diffusion membranes 1200 and 1300 may be hydrophilic. In some embodiments, one or both of the first and second proliferation diffusion membranes 1100 and 1400 and / or one or both of the first and second constriction diffusion membranes 1200 and 1300 may be hydrophobic. Thus, in some examples, the aqueous humor diffusion member 1002 may include one or more hydrophilic membranes, and one or more hydrophobic membranes.
i zarnn / nznz / zi / Yl
Accordingly, hydrophilic coatings to allow wetting of the polymeric matrix can also be applied as if the polymeric surfaces were hydrophobic in nature. Surface coatings comprising antioxidant components can be applied to mitigate the body's inflammatory response that occurs naturally during wound healing after surgery. Surfaces can be modified with antiproliferative compounds (eg, Mitomycin C, 5-fluoracil), to moderate the response of the surrounding tissue in the eye. In some examples, one or more surface preconditioning processes may additionally or alternatively be used to form layers that exhibit a preferred microstructure (eg, wrinkles, folds, or other out-of-plane geometric structures), as explained in US Pat. States number 9,849,629 of Zagl et al. Such surface preconditioning could facilitate a more marked early inflammatory phase after surgery, providing an early stable interface between the porous device and tissue. In some examples, a heparin coating (eg, resistant thrombus) can be additionally or alternatively applied to help minimize or reduce cell formation, including fibrinogen accumulation after a surgical implantation procedure.
In some embodiments, one or more perforation processes may be used additionally or alternatively to form a plurality of perforations or small holes in the polymeric material (s) in addition to any perforations or small holes that occur naturally in the ( the) polymeric material (s), which operate to increase a natural permeability (eg, a permeability to aqueous humor) of the polymeric material (s). Such perforation processes can increase several perforations or small holes present in the polymeric materials and / or can increase an average size of the perforations or small holes present in the polymeric materials, and can be performed before and / or after the formation of the membranes. diffusion of proliferation and / or constriction. In some embodiments, the permeability of the first and / or second proliferation diffusion membranes 1100 and 1400 and / or the first and second constriction diffusion membranes 1200 and 1300 can be altered to tune or otherwise modify resistance to flow and / or aqueous humor flow for a desired amount.
In various embodiments, the first and / or second proliferation diffusion membranes 1100 and 1400 may include perforations or small holes ranging in size (or with an average size) of between twenty (20) microns and one hundred (100) microns. In other examples, the size (or average size) of the perforations or small holes in the first and / or second proliferation diffusion membranes 1100 and 1400 may be greater than one hundred fifty (150) microns. In various embodiments, the first and / or second proliferation diffusion membranes 1100 and 1400 may include perforations or small holes smaller than twenty (20) microns, but greater than one (1) or two (2) microns, as perforations or small holes smaller than one (1) or two (2) microns generally inhibit, resist, or impede growth into vessels and other tissues.
Accordingly, in various embodiments, the first and second constriction diffusion membranes 1200 and 1300 are configured or selected such that the perforations or small holes in them are generally sized to be less than (or have an average size less than ) one (1) micron or two (2) microns to minimize, resist, or prevent inward growth and tissue fixation, while maintaining aqueous humor permeability.
It should be understood that the first and second proliferation diffusion membranes 1100 and 1400 can be configured to have the same permeability or different permeabilities. Similarly, it should be understood that the first and second constriction diffusion membranes 1200 and 1300 can be configured to have the same or different permeabilities. In some examples, the various proliferation and constriction diffusion membranes discussed herein may possess the same inherent permeabilities, but may undergo one or more of the material modification processes discussed herein to achieve different relative permeabilities. In some embodiments, one or more of the material modification processes discussed herein operate to change or otherwise modify the natural permeability of the polymeric material or materials. Thus, in some embodiments, the permeabilities of proliferating and / or constricting diffusion membranes may be based on the natural microstructure of the polymeric material (s) and / or one or more of the material modification processes mentioned herein. Those skilled in the art will understand that permeability is generally related to the resistance of a fluid that is transported through the pore space of the porous media, and that materials associated with low permeabilities exhibit greater resistance to flow than those materials with higher permeability.
In some embodiments, the perforations or small holes in the proliferating and constricting diffusion membranes can be formed by one or more salt inclusion processes, or by the use of one or more piercing, punching, needle punching, or shearing processes. laser, which can be carried out before and / or after the formation of the proliferation and / or diffusion membranes by constriction.
In general, the processes described above can be used to form proliferative diffusion membranes that have a microstructure that allows growth into surrounding vessels and other tissues, and that is permeable to aqueous humor. Similarly, the processes described above can be used to form constricting diffusion membranes that have a microstructure that minimizes, resists, or prevents inward growth of surrounding vessels and other tissues, but is permeable to aqueous humor. Aqueous humor that is filtered and / or diffused through the constricting and proliferating diffusion membranes can be absorbed by the vessels that have grown in the proliferation diffusion membranes and / or vessels outside the aqueous humor diffusion member. 1002, and / or can leak through surrounding tissues and into the tear film.
As mentioned above, in some embodiments, the observed differential pressure between reservoir 1010 of the glaucoma drainage system 1000 and the environment outside the glaucoma drainage system 1000 (e.g., atmospheric pressure) is a mechanism that facilitates the flow of aqueous humor through the aqueous humor diffusion member 1002 of the glaucoma drainage system 1000. In some embodiments, the mechanism of reabsorption and elimination of the evacuated aqueous humor by the vessels that grow in and surround the glaucoma drainage system 1000 helps to facilitate the evacuation of aqueous humor from the anterior chamber.
However, it should be understood that, in addition to facilitating the reabsorption and removal of evacuated aqueous humor, the inward growth of tissues, vessels and cells in the proliferation diffusion membranes of the aqueous humor diffusion member 1002 also helps prevent , reduce, minimize or limit the appearance of tissue responses to foreign bodies. Specifically, as mentioned above, tissue ingrowth and fixation helps minimize relative movement between the Glaucoma Drainage System 1000 and the eye tissue. By helping to minimize such relative movement, the Glaucoma Drainage System 1000 helps prevent eye tissue irritation that can occur that can lead to a tissue response to a foreign body, which can lead to excessive scarring and / or or erosion and infection of the site of the glaucoma 1000 drainage system.
In some embodiments, one or more of the adjacently located diffusion membranes that form the body of the aqueous humor diffusion member 1002 are connected or otherwise coupled to each other. In some embodiments, the adjacent diffusion membranes are coupled at one or more discrete portions or regions along their adjacent interface surfaces. In some embodiments, the adjacently located diffusion membranes may be coupled along at least a portion of a contiguous edge (or edges). In other embodiments, the adjacently located diffusion membranes may additionally or alternatively engage at one or more discrete locations along adjacent surfaces inside the edge (or edges). In still other embodiments, the adjacently positioned diffusion membranes can be engaged along a totality of their adjacent interface surfaces (eg, by applying an adhesive along a surface area of the adjacent facing interface surfaces). Thus, in some embodiments, one or more of the adjacently located diffusion membranes may be coupled on fewer than all of their adjacent interface surfaces (eg, at discrete locations or a portion thereof) or they may be coupled along a totality of interface surfaces that face each other.
In those embodiments where the adjacently located diffusion membranes are coupled along a portion of less than all of their adjacent facing interface surfaces, one or more discrete locations along the adjacent facing interface surfaces are connected. or coupled, while one or more discrete locations along adjacent facing interface surfaces are not coupled to each other. That is, in some embodiments, at least one region or area of adjacent interface surfaces intentionally remains unbonded, unbonded, or otherwise uncoupled.
In some such embodiments, these decoupled regions or areas may include regions or areas central to a peripheral edge. Generally, these uncoupled regions or areas are free to move or slide relative to one another, and can be separated from one another to act as a reservoir for the accumulation of evacuated aqueous humor. In several examples, providing such a degree of freedom (for example, in shear) provides considerable flexibility as the diffusion membranes can move relative to each other to accommodate changes in curvature as the aqueous humor diffusion member 1002 is moved. it bends and moves, just like a natural eye movement. Therefore, the discontinuity of the coupling of the diffusion membranes provides a glaucoma drainage system 1000 that exhibits better ocular compliance and is better suited to respond dynamically to changes in the curvature of the eye 2000 as the patient blinks. , focus and move the eye within the eye socket. Unlike more rigid conventional designs, the increased flexibility also minimizes movement of the Glaucoma Drainage System 1000 in relation to the surrounding tissue.
Referring to Figure 4A, Figure 4B, Figure 4C and Figure 4D, examples of interface surfaces are illustrated that include coupled and uncoupled (eg, bonded and unjoined) regions. Figure 4A is a cross-sectional view of the second interface surface 1204 taken along the boundary (4-4, Figure 2) located between the adjacent first and second interface surfaces 1204 and 1302, and where the conduit fluid 1500 is removed for clarity. As mentioned above, in some embodiments, adjacent interface surfaces may be coupled to each other at a plurality of discrete locations such that adjacent interface surfaces i zarnn / nznz / zi / Yl · include coupled regions and decoupled regions. Figure 4A shows the second interface surface 1204 of the first constricting diffusion membrane 1200, which includes coupled regions 1210 (illustrated as shaded regions) wherein the second interface surface 1204 is coupled to the first interface surface 1302 facing each other. adjacent to the second constricting diffusion membrane 1300, as well as a coupling along the peripheral edge 1206. As shown in Figure 4A, the second interface surface 1204 of the first constriction diffusion membrane 1200 also includes decoupled regions 1208 (illustrated as regions between and around the shaded regions) where the second interface surface 1204 is positioned adjacent to, but otherwise uncoupled from, the adjacent facing first interface surface 1302 of the second constricting diffusion membrane 1300. In this illustrated example of Figure 4A, the first and second adjacent facing interface surfaces 1204 and 1302 are free to slide and move relative to each other along the uncoupled regions 1208. In addition, these uncoupled regions 1208 are free to separate. together to form reservoir 1010 for accumulation of aqueous humor.
It will be understood that while the uncoupled regions 1208 between the first and second constriction diffusion membranes 1200 and 1300 shown in Figure 4A, Figure 4B, Figure 4C, and Figure 4D are free to separate from each other to form the reservoir 1010, the coupled regions 1210 are configured to remain coupled. In various examples, these coupled regions 1210 operate to control the profile of the glaucoma drainage system 1000 as the reservoir 1010 inflates or dilates.
Figure 4B is a cross-sectional view of the second interface surface 1204 taken along the boundary (4-4, Figure 2) that lies between the adjacent first and second interface surfaces 1204 and 1302 facing each other. Figure 4B illustrates another configuration where the second interface surface 1204 includes a centrally positioned coupled region 1210 (illustrated as shaded regions) and where the second interface surface 1204 is coupled to the adjacent facing first interface surface 1302 of the second constriction diffusion membrane 1300 in addition to being coupled along the peripheral edge 1206. Although not illustrated, it should be understood that the coupling configurations of Figure 4B and Figure 4A may be combinable in whole or in part.
Figure 4C illustrates another configuration where the second interface surface 1204 includes a peripherally positioned coupled region 1210 (shown as a shaded region), while the second interface surface 1204 is coupled to the adjacent facing first interface surface 1302. of the second constriction diffusion membrane 1300. Although not illustrated, it should be understood that the coupling configurations of Figure 40, Figure 4B and / or Figure 4A may be combined in whole or in part.
Figure 4D illustrates another alternative configuration where the second interface surface 1204 includes a peripherally positioned coupled region 1210 and an internally coupled concentric annular region 1210 (both illustrated as shaded regions) and where the second interface surface 1204 is coupled. to the adjacent facing first interface surface 1302 of the second constriction diffusion membrane 1300. The configuration shown in Figure 4D is one that includes the possibility of two different reservoirs for the accumulation of aqueous humor. The first reservoir corresponds to the disengaged portion 1208 radially inward of the concentric annular region of internal engagement 1210 radially inward of the peripherally positioned engaged region 1210 around the periphery 1206. The second reservoir corresponds to the disengaged portion 1208 located between the concentric annular internal coupling region 1210 and the peripherally positioned coupled region 1210. It should be understood that a first fluid conduit may be fluidly coupled with the first reservoir, while a second fluid conduit is coupled with the second reservoir of the configuration shown in Figure 4D. Alternatively, a single fluid conduit may be fluidly coupled with the first and second reservoirs shown in Figure 4D, such as through corresponding openings in the fluid conduit. In another alternative example, a portion smaller than the entire concentric annular region of internal engagement 1210 may alternatively be disengaged so that the first and second reservoirs are fluidly engaged. Although not illustrated, it should be understood that the coupling configurations of Figure 4D, Figure 4C, Figure 4B and / or Figure 4A may be combined in whole or in part.
It should also be understood that while Figure 4A, Figure 4B, Figure 4C, and Figure 4D illustrate examples of coupled and uncoupled (eg, bonded and uncoupled) regions of the second interface surface 1204, the first surface Adjacent facing interface 1302 includes coupled and uncoupled regions corresponding to coupled and uncoupled regions, respectively, of the second interface surface 1204. Furthermore, it should be understood that the embodiments illustrated in Figure 4A, Figure 4B, Figure 4C, and Figure 4D are not to be construed as limiting the description to the embodiments illustrated. Rather, those skilled in the art will understand that virtually any pattern of coupled and uncoupled regions can be used without departing from the spirit or scope of the description.
Although the boundary between the first proliferation diffusion membrane 1100 and the first constriction diffusion membrane 1200 is not illustrated, it should be understood that the first and second adjacent facing interface surfaces 1202 and 1104 can be evenly coupled throughout. the limit or alternatively according to the aforementioned modalities. Similarly, although the boundary between the second proliferation diffusion membrane 1400 and the second constriction diffusion membrane 1300 is not illustrated, it should be understood that the adjacent first and second facing interface surfaces 1402 and 1304 may be uniformly coupled to along the entire boundary or alternatively coupled according to the aforementioned modalities.
As previously indicated, adjacent diffusion membranes can be connected or coupled to each other by means of one or more heat treatment processes and / or one or more bonding agents, such as one or more adhesives. In some embodiments, the adjacent diffusion membranes and / or the layers of material that form a diffusion membrane are partially or fully bonded by thermal methods when each of the materials is brought to or above their melting temperatures. . In some embodiments, such thermal processes facilitate the formation of adhesive or cohesive bonds between polymeric materials or layers of polymeric material. In some embodiments, the adjacently located diffusion membranes that form a diffusion membrane are partially or completely bonded by thermal methods when at least one of the materials is brought to or above its melting temperature. In some embodiments, such thermal processes facilitate the formation of adhesive or cohesive bonds between materials or layers of material. In some embodiments, one or more suitable adhesives are used and provide a sufficiently bonded interface, which can be continuous or discontinuous.
As mentioned above, in various embodiments, the glaucoma drainage system 1000 can be operated or is otherwise configured to evacuate aqueous humor from the anterior chamber (AC) of the eye. In some embodiments, the glaucoma drainage system 1000 includes a fluid conduit 1500, as shown in at least Figure 1. In various embodiments, the fluid conduit 1500 is a flexible tubular structure (eg, a catheter) that extends into the aqueous humor diffusion member 1002 and fluidly couples the aqueous humor diffusion member 1002 and the anterior chamber of the eye. Fluid conduit 1500 provides fluid outlet from the anterior chamber. As shown in Figure 3, fluid conduit 1500 includes a first end 1502 and a second end 1504, and a lumen extending from first end 1502 to second end 1504. Generally, fluid conduit 1500 can be formed of silicone, ePTFE, polycarbonate, polyethylene, polyurethane, polysulfone, PVDF, PHFP, PFA, polyolefin, FEP, acrylic copolymers and other suitable fluoro-copolymers, alone or in combination, or any other Biocompatible polymer suitable for forming a flexible fluid conduit 1500.
In some embodiments, fluid conduit 1500 is formed by a tubular melt extrusion process. In some embodiments, an extruded fluid conduit 1500 can be brought to a final target dimension. In some embodiments, the fluid conduit 1500 is formed through a tubular paste extrusion and expansion process in accordance with producing a desired wall thickness, porosity, stiffness, and / or dimension. In some embodiments, fluid conduit 1500 is formed by one or more tape wrapping processes, wherein a tape is wrapped around a mandrel of a designated dimension and cross section. In some embodiments, the rolled tape can be attached to itself by one or more thermal or adhesive methods before or after removal from the mandrel. In various embodiments, a wrapped tape configuration (eg, ePTFE or other suitable materials as described herein) provides a fluid conduit construction 1500 that has different layers with different porosities. For example, an inner wound layer may be more porous than an outer wound layer. In some embodiments, the fluid conduit 1500 is formed by successively dip coating a material onto a mandrel of the appropriate size followed by removal of the solvent and removal of the mandrel from the formed fluid conduit 1500.
In some embodiments, a diameter of the lumen of the fluid conduit 1500 is sufficient to allow the flow of aqueous humor through the fluid conduit 1500 from the anterior chamber to the aqueous humor diffusion member 1002, but that does not result in a fluid conduit 1500 with an outer diameter that significantly interferes with or affects normal ocular functions (eg, does not interfere with blinking or regular eye movement).
As mentioned above, fluid conduit 1500 fluidly couples aqueous humor diffusion member 1002 to the anterior chamber of the eye so that aqueous humor can be evacuated from the anterior chamber and delivered to aqueous humor diffusion member 1002. , and in particular to the reservoir defined within the interior region of the aqueous humor diffusion member 1002. Consequently, the fluid conduit 1500 is configured to extend between the anterior chamber of the eye and the position in the eye where the aqueous humor diffusion member 1002 is mounted or otherwise integrated. In some embodiments, a length of the fluid conduit 1500 may be between one (1) millimeter and thirty (30) millimeters, although generally the length of the fluid conduit 1500 is large (or otherwise longer than necessary) so that a physician can trim its length to a specific length required for the unique anatomy of the patient. However, in various embodiments, the length and diameter of the lumen of the fluid conduit 1500 are preselected to control the pressure drop along the length to minimize the risk of hypotonia (eg, dangerously low eye pressure), since the pressure drop across fluid conduit 1500 is a function of the length of fluid conduit 1500. In some embodiments, fluid conduit 1500 may be pre-marked with cut-length identifiers that correspond to theoretically expected pressure drops when implanted. Such a configuration provides the physician with an option to specifically tailor the pressure drop to the particular needs of the patient. In such embodiments, after trimming the fluid conduit 1500 to the length corresponding to the desired pressure drop, the physician may optionally advance the first end 1502 of the fluid conduit 1500 further into the anterior chamber, or alternatively position the diffusion of aqueous humor 1002 further from the point of penetration of the fluid conduit 1500 into the anterior chamber (e.g., at a greater distance around the eye) to accommodate a desired length.
In various embodiments, the fluid conduit 1500 can be porous or non-porous, or it can include a combination of porous portions and non-porous portions. For example, in some embodiments, the fluid conduit 1500 may have a length defined by a first portion (or region) and a second portion (or region). In some embodiments, the first portion can be a non-porous portion while the second portion is a porous portion. In some embodiments, the non-porous portion is impermeable to aqueous humor while the porous portion is permeable to aqueous humor. Thus, in some embodiments, aqueous humor evacuated from the anterior chamber via fluid conduit 1500 may leak through the porous portion of fluid conduit 1500. For example, the portion of the fluid conduit 1500 in the anterior chamber may have an outer surface that is impervious to aqueous humor or cell penetration, while a portion of the fluid conduit 1500 outside of the anterior chamber may allow or otherwise support cellular infiltration and inward growth and biointegration of tissue. In some embodiments, an internal surface of fluid conduit 1500 may be impermeable to aqueous humor and is configured to minimize bacterial ingress and growth into vessels and tissue structures.
In some embodiments, the porous portion of the fluid conduit 1500 may be formed by subjecting a region (eg, a portion of the length of the fluid conduit 1500) to one or more of the above-mentioned drilling processes to form a plurality of perforations in the subjected region. However, the fluid conduit 1500 need not include a portion that is permeable to aqueous humor.
Generally, the flow of aqueous humor through the glaucoma drainage system 1000 is governed by a pressure difference between the infraocular pressure and the pressure within the aqueous humor diffusion member 1002 (e.g., which is a function of the forces acting on the aqueous humor diffusion member 1002, such as atmospheric pressure). A pressure difference between these pressure regions will cause the aqueous humor to flow from the anterior chamber to the glaucoma drainage system 1000. In some embodiments, the rate at which the aqueous humor flows through the glaucoma drainage system 1000 is governed by this pressure difference and a resistance to flow. In some embodiments, flow resistance is a function of the flow resistance of the fluid conduit (for example, based on tube geometry, diameter, and length, generally based on the Hagen-Poiseuille equation) and a resistance to the flow of aqueous humor through aqueous humor diffusion member 1002, as will be understood by those skilled in the art. In some embodiments, as mentioned above, a resistance to aqueous humor flow through the aqueous humor diffusion member 1002 can be controlled by a permeability of the underlying materials that form the aqueous humor diffusion member 1002.
As mentioned above, the fluid conduit is a soft and flexible biocompatible tubular structure. In some embodiments, the fluid conduit 1500 is flexible in that it exhibits low column strength and is generally unable to support its own weight. That is, in some embodiments, the fluid conduit 1500 lacks a sufficient amount of structural integrity (eg, compression ring strength) necessary to prevent collapse (eg, a collapse of the internal lumen extending through 1500) under its own weight.
In some embodiments, the anterior chamber infraocular pressure is inflated or otherwise operated to maintain the generally tubular geometry (eg, prevent collapse of internal lumen 1506A) of fluid conduit 1500. That is, in some embodiments, Aqueous humor flowing through the lumen of fluid conduit 1500 operates to inflate the lumen. Such a configuration provides a smooth and flexible fluid passage 1500 that conforms to the curvature of the eye and avoids interfering with the normal function of the eye (eg, pivoting and blinking). It should be understood that, in some embodiments, the fluid conduit 1500 may alternatively be constructed so that it exhibits a sufficient amount of structural integrity to maintain its generally tubular geometry and / or prevent internal lumen collapse.
Referring again to Figure 3, in some embodiments, fluid conduit 1500 includes a first end 1502 and an opposite second end 1504. In some embodiments (not illustrated in Figure 3), fluid conduit 1500 includes a lumen that extends from first end 1502 to second end 1504. In some embodiments, the first end 1502 can be inserted into the anterior chamber and the second end 1504 is inserted or attached to the aqueous humor diffusion member 1002. In some embodiments, the first end 1502 can be positioned within the anterior chamber. such that the first end 1502 extends into an interior region of the anterior chamber.
In some embodiments, after placing the first end 1502 of the fluid conduit 1500 in the anterior chamber, the fluid conduit 1500 can be secured to prevent displacement of the fluid conduit 1500 from within the anterior chamber. In some embodiments, one or more stitches are used to couple fluid conduit 1500 and / or aqueous humor diffusion member 1002 to eye tissue. In some embodiments, a biocompatible tissue adhesive is used to bond the fluid conduit 1500 and / or aqueous humor diffusion member 1002 to surrounding or adjacent tissue. In some embodiments, a needle path that is created through tissue prior to placement of fluid conduit 1500 may be sized to provide sufficient interface fit with fluid conduit 1500 along the needle tract. In some embodiments, the first end 1502 of the fluid conduit 1500 may additionally or alternatively widen to a larger diameter than other portions (eg, a central portion) of the fluid conduit 1500 (or a lumen in the tissue through the which extends the fluid conduit 1500) to create an interference fixture that helps maintain the placement of the first end 1502 within the anterior chamber of the eye. In some examples, the first flared end 1502 of the fluid conduit 1500 helps prevent displacement of the fluid conduit 1500 from its position within the anterior chamber.
In some embodiments, the second end 1504 of the fluid conduit 1500 is coupled with the aqueous humor diffusion member 1002 such that the reservoir defined within the aqueous humor diffusion member 1002 is fluidly coupled with the fluid conduit 1500. , and thus the fluid-filled body cavity (eg, the anterior chamber of the eye) when the glaucoma drainage system 1000 is implanted within the body. In some embodiments, the second end 1504 of fluid conduit 1500 extends into or otherwise terminates within aqueous humor diffusion member 1002, such as between the first and second constricting diffusion membranes 1200 and 1300. that define the repository. For example, as shown in Figure 5, fluid conduit 1500 is coupled to aqueous humor diffusion member 1002 such that fluid conduit 1500 terminates within an interior of aqueous humor diffusion member 1002. That is, in some embodiments, the second end 1504 is coupled to the aqueous humor diffusion member 1002 such that the evacuated aqueous humor exiting the fluid conduit 1500 at the second end 1504 is diffused or injected into the aqueous humor member. diffusion of aqueous humor 1002 starting at some position inside its periphery 1008. Although not shown separately from one another in Figure 5, it should be understood that the first and second constriction diffusion membranes 1200 and 1300 can be operated to separate from each other, as mentioned above, so that the deposit is unreliable or reliable. dilatable.
LZQrnn / nznz / q / Yi
As shown in Figure 5, aqueous humor traveling through fluid conduit 1500 along arrow 1602 exits second end 1504 of fluid conduit 1500 and diffuses or is otherwise injected into reservoir 1010. As mentioned above, reservoir 1010 may include the pore space of the first and second diffusion constriction membranes 1200 and 1300 and / or a defined region between the first and second diffusion constriction membranes 1200 and 1300. As shown in Figure 5, aqueous humor is shown exiting fluid conduit 1500 into reservoir 1010, which includes at least the region defined between the first and second constriction diffusion membranes 1200 and 1300.
As the evacuated aqueous humor leaks through the constricting and diffusion membranes of the aqueous humor diffusion member 1002, the aqueous humor generally leaks to an exterior of the aqueous humor diffusion member 1002, as shown by the arrows 1604A-1604E. It should be understood that arrows 1604A1604E are not intended to represent actual aqueous humor pathways, but are intended to represent that aqueous humor is intended to leak away from an interior region, such as reservoir 1010, of the aqueous humor diffusion member. 1002 or at least away from the second end 1504 of the fluid conduit 1500.
In some other embodiments, the second end 1504 of the fluid conduit 1500 is coupled to the periphery 1008 of the aqueous humor diffusion member 1002. For example, as shown in Figure 6, the second end 1504 of the fluid conduit 1500 is coupled to aqueous humor diffusion member 1002 at its periphery 1008. That is, in some embodiments, the second end 1504 is coupled to the aqueous humor diffusion member 1002 so that the evacuated aqueous humor exiting the fluid conduit 1500 at the second end 1504 is diffused or otherwise injected into the first and second constriction diffusion membranes 1200 and 1300, beginning at or near a periphery 1008 of the aqueous humor diffusion member 1002.
In some such embodiments, as the evacuated aqueous humor leaks through the aqueous humor diffusion member 1002, the aqueous humor may leak into an interior of the aqueous humor diffusion member 1002 and / or it may leak outward. of the aqueous humor diffusion member 1002. In some embodiments, when aqueous humor traveling through fluid conduit 1500 exits second end 1504 of fluid conduit 1500 between the first and second constriction diffusion membranes 1200 and 1300, as mentioned above. As similarly mentioned above, aqueous humor enters reservoir 1010 of aqueous humor diffusion member 1002, which may be defined between first and second constriction diffusion membranes 1200 and 1300, or which may additionally or alternatively correspond to the pore space of the first and second constriction diffusion membranes 1200 and 1300.
i zarnn / nznz / zi / Yl
As mentioned above, the glaucoma drainage system 1000 is configured to allow evacuated aqueous humor to seep from within the aqueous humor diffusion member 1002 to an exterior of the aqueous humor diffusion member 1002.
Arrows 1604A-1604C in Figure 6 are representative of aqueous humor that generally seeps through aqueous humor diffusion member 1002. As shown, arrow 1604A represents aqueous humor that is filtered through aqueous humor diffusion member 1002 generally into an interior region of aqueous humor diffusion member 1002, while arrows 1604B and 1604C represent aqueous humor that it is filtered through the aqueous humor diffusion member 1002 generally to an exterior of the aqueous humor diffusion member 1002. As mentioned above, it should be understood that arrows 1604A-1604C are not intended to represent actual pathways of the aqueous humor, but rather are intended to represent that the aqueous humor is intended to leak at least away from the second end 1504 of the fluid conduit 1500 . Furthermore, although they are not shown separately from one another in Figure 6, it will be understood that the first and second constriction diffusion membranes 1200 and 1300 can be operated to separate from each other to define reservoir 1010 between them.
In various embodiments, the second end 1504 of the fluid conduit 1500 may be coupled to the periphery 1008 of the aqueous humor diffusion member 1002 by means of an adhesive, a weld, seam, or one or more mechanical clamping mechanisms. In some embodiments, the second end 1504 of the fluid conduit 1500 may be coupled to the periphery 1008 by one or more of the thermal bonding methods noted above to create an adhesive or cohesive bond between the material or layers of material.
In various embodiments, fluid conduit 1500 is coupled to aqueous humor diffusion member 1002 so that evacuated aqueous humor exiting fluid conduit 1500 at second end 1504 diffuses into a constricting diffusion membrane before diffusing. on a proliferating diffusion membrane. For example, as shown in Figures 5 and 6, the second end 1504 of the fluid conduit 1500 is coupled to the aqueous humor diffusion member 1002 so that the evacuated aqueous humor exiting the fluid conduit 1500 at the second end 1504 diffuses into one or more of the first and second constriction diffusion membranes 1200 and 1300 before diffusing into the first and second proliferation diffusion membranes 1100 and 1400.
Unlike conventional designs, the Glaucoma Drainage System 1000 is soft and flexible, and does not require the preservation of a hollow aqueous humor reservoir internal to its aqueous humor diffusion member 1002. Therefore, the humor reservoirs Conventional hollow and permeable aqueous must be sufficiently rigid to preserve their volumes. Consequently, compared to the Glaucoma Drainage System 1000, conventional designs are relatively rigid and susceptible to causing relative movement between the tissue and the device and thus tissue irritation that can lead to excessive formation of scars and erosion of conventional devices.
As noted above, in various embodiments, the aqueous humor diffusion member 1002 includes one or more adjacently located diffusion membranes that have adjacent facing interface surfaces that can slide or otherwise move relative to each other. In some embodiments, the aqueous humor evacuated from the anterior chamber and introduced into the aqueous humor diffusion member 1002 functions as a lubricant that reduces friction between such interface surfaces and further facilitates sliding or relative movement between the portions or decoupled regions. Specifically, when the aqueous humor enters the aqueous humor diffusion member 1002, the aqueous humor is filtered and diffused through the various diffusion membranes. As the aqueous humor is filtered and diffused through the diffusion membranes, part of the aqueous humor diffuses through the boundaries that separate the adjacent diffusion membranes. In some embodiments, as the aqueous humor diffuses through the boundary, it functions as a lubricant that reduces friction between the interface surfaces of the boundary, further increasing the flexibility of the aqueous humor diffusion member 1002.
As noted above, in some embodiments, fluid conduit 1500 is smooth and flexible, and generally lacks a sufficient amount of structural integrity (eg, ring strength) to avoid collapsing under its own weight. In some embodiments, this lack of structural integrity results in a deformation of the fluid conduit 1500 as the lumen extending through it loses a significant portion of its cross-sectional area. In some embodiments, this lack of structural integrity results in a deformation of the fluid conduit 1500 to the extent that the aqueous humor in the anterior chamber is significantly restricted even to enter the lumen of the fluid conduit 1500. In some embodiments, to avoid these potential hazards, the fluid conduit 1500 can be configured such that one or more of its ends are sufficiently structurally sound so that they can be operated to maintain the integrity of the lumen and avoid collapse or significant deformation. of the light. In such embodiments, an intermediate portion of the fluid conduit 1500 located between the first and / or second ends 1502 and 1504 is generally not structurally sound, as it cannot support its own weight. For example, the end (or an end portion) of the fluid conduit 1500 that is positioned within the anterior chamber is configured so that it can be operated to maintain the integrity of the lumen and prevent significant collapse or deformation of the lumen. . In this example, the aforementioned risks associated with relative movement and irritation of tissues due to stiffness are generally avoided because the structurally sound end of fluid conduit 1500 is suspended within the aqueous humor of the anterior chamber and, therefore, it does not interact with tissue in a way that could cause tissue irritation.
In various embodiments, the fluid conduit material 1500 may undergo one or more material conditioning processes to achieve structurally sound first and / or second ends. In some embodiments, one or more structural members, such as one or more stents, struts, or reinforcing rings may be incorporated, integrated, or otherwise coupled to the first and / or second ends 1502 and 1504 to achieve the aforementioned structural integrity. These stents, struts, and / or reinforcing rings can be formed of any suitable biocompatible polymeric or metallic material mentioned herein (eg, FEP). In some embodiments, a localized densification at the first and / or second ends 1502 and 1504 of the fluid conduit 1500 can increase its structural integrity to a degree sufficient to withstand closing forces exerted at the ends by body tissue.
While the aqueous humor diffusion member 1002 illustrated and described herein includes a body defined by four diffusion membranes, the body of the aqueous humor diffusion member 1002 may alternatively be defined by as few as three diffusion membranes or in excess. of four diffusion membranes without departing from the spirit or scope of the present disclosure. For example, although the aforementioned embodiments include an aqueous humor diffusion member 1002 that includes a plurality of constriction diffusion membranes and a plurality of proliferation diffusion membranes, in some embodiments, the aqueous humor diffusion member 1002 includes a constriction diffusion membrane sandwiched between a plurality of proliferation diffusion membranes. For example, referring to Figure 7A and Figure 7B, a glaucoma drainage system 7000 is shown and includes an aqueous humor diffusion member 7002 defined by a first proliferation diffusion membrane 7100, a first diffusion membrane of constriction 7200 and a second proliferation diffusion membrane 7300. As shown, the first constriction diffusion membrane 7200 is located between the first and second proliferation diffusion membranes 7100 and 7300. The first constriction diffusion membrane 7200 is configured to minimize, resist, or prevent inward growth. and tissue fixation, while the first and second proliferation diffusion membranes 7100 and 7300 are configured to allow tissue growth and fixation. Figure 7A shows the 7000 Glaucoma Drainage System in a deflated state. Figure 7B shows the 7000 glaucoma drainage system in an inflated state, wherein aqueous humor is present within an inflexible or expandable reservoir 7010 defined between the first proliferation diffusion membrane 7100 and the first constriction diffusion membrane 7200. . While the 7000 glaucoma drainage system is shown in Figure 7B in an inflated state, wherein the 7000 glaucoma drainage system is not inflated evenly (for example, the first proliferation diffusion membrane 7100 is shown adopts a generally non-linear configuration, while the second proliferation diffusion membrane 7300 and the constriction diffusion membrane 7200 are shown in a generally linear configuration), It should be understood that the 7000 glaucoma drainage system may deform uniformly (for example, the second proliferation diffusion membrane 7300 and the diffusion constriction membrane 7200 can be deformed to reflect the deformation of the first proliferation diffusion membrane 7100 ). The fluid conduit 7500 may be located between the first constriction diffusion membrane 7200 and one of the first and second proliferation diffusion membranes 7100 and 7300. As shown, the fluid conduit 7500 is located between the first diffusion membrane. Constriction 7200 and First Proliferation Diffusion Membrane 7100. The proliferating and constricting diffusion membranes may be coupled to one another along a totality of their adjacent surface areas, or they may include one or more unjoined or uncoupled areas or regions, consistent with the above.
As shown in Figure 7B, the first constriction diffusion membrane 7200 and the first proliferation diffusion membrane 7100 are coupled along their peripheral edges, but include an unbound or uncoupled region within their interior, which defines the deposit 7010. Therefore, the unbonded or uncoupled regions between the first constriction diffusion membrane 7200 and the first proliferation diffusion membrane 7100 may separate from each other as the reservoir 7010 inflates or expands as aqueous humor enters the reservoir. 7010.
It should be understood that the configuration of the glaucoma drainage system 7000 shown in Figure 7A and Figure 7B includes a reservoir 7010 that is defined between a constricting diffusion membrane and a proliferation diffusion membrane. Such a configuration provides that inward growth of the tissue is allowed along one side of the reservoir, while inward growth of the tissue is minimized, resisted or prevented along another side of the reservoir. Furthermore, as the constriction diffusion membrane and the proliferation diffusion membrane are associated with different permeabilities, the evacuated aqueous humor will leak through the constriction diffusion membrane and the proliferation diffusion membrane at different rates.
In some embodiments, these differential rates at which aqueous humor diffuses or leaks through different membranes can be used to influence, direct, or "guide" aqueous humor through the aqueous humor diffusion member. In some embodiments, the aqueous humor diffusion member can be configured so that a greater percentage (or a higher volume) of aqueous humor is directed toward a first exterior surface of the aqueous humor diffusion member than toward a second exterior surface of the aqueous humor. aqueous humor diffusion member. Also, in some embodiments, the aqueous humor diffusion member can be configured such that a percentage of the aqueous humor is directed toward a periphery of the aqueous humor diffusion member. Such configurations provide that the evacuated aqueous humor can be directed to a designated region of the surrounding tissue, such as a region of the surrounding tissue that is more adapted to absorb the evacuated aqueous humor and that is more adapted to facilitate absorption into the tear film.
For example, with continued reference to Figure 7A and Figure 7B, in some embodiments, the first proliferation diffusion membrane 7100 has a higher flux than the flow rate of the first constriction diffusion membrane 7200 and therefore a greater percentage (or greater volume) of aqueous humor is directed towards an outer surface that extends along the first proliferation diffusion membrane 7100 relative to a percentage (or volume) of aqueous humor that is directed towards an outer surface extending along the second proliferation diffusion membrane 7400. It should be understood that, in some embodiments, such a configuration may be additionally or alternatively achieved by forming a first constriction diffusion membrane having a flux greater than the flow of a second constriction diffusion membrane. In some embodiments, such a configuration is additionally or alternatively achieved by forming the first proliferation diffusion membrane so that it has a flux greater than the flux of the second proliferation diffusion membrane. In some embodiments, such a configuration can be additionally or alternatively achieved by forming the boundaries between adjacently located diffusion membranes so that different boundaries are associated with a different flux. Different limits associated with different flux can be achieved through the manner in which adjacent located diffusion membranes adhere or bond to each other.
While the 7000 glaucoma drainage system shown in Figure 7A and Figure 7B includes a 7500 fluid conduit that is located between the first proliferation diffusion membrane 7100 and the first constriction diffusion membrane 7200, and a reservoir 7010 which is defined between the first proliferation diffusion membrane 7100 and the first diffusion constriction membrane 7200, It should be understood that the first constricting diffusion membrane may be formed of a plurality of laminated layers of polymeric material (as noted above) and the fluid conduit 7500 may be located between adjacent layers of polymeric material. Additionally or alternatively, in some examples, one or more of the adjacent layers of polymeric material that form the constriction membrane may include one or more unbonded, uncoupled, or unlaminated areas or regions, in accordance with the description above, so that the unbonded, uncoupled, or unlaminated areas or regions of adjacent layers of polymeric material remain free to separate, slide, or move relative to each other and may define, at least in part, deposit 7010.
It should be understood that while the aqueous humor diffusion members illustrated and described herein are generally thin, flat, and circular (or ovular), the aqueous humor diffusion member may have any suitable shape without departing from the spirit or scope of the description. For example, the aqueous humor diffusion member can be square, rectangular, trapezoidal, or some other polygonal shape, and can include beveled or rounded edges between the sides, and the sides can be linear or generally curved in nature. Alternatively, the aqueous humor diffusion member may have a generally continuous curved edge in the sense that it is circular or ovular, or otherwise suitable (eg, bean-shaped). Accordingly, the embodiments and illustrations included herein are not to be construed as limiting, and those skilled in the art will understand that the aqueous humor diffusion member can have any desired shape, as long as the aqueous humor diffusion member can be operated to to accommodate a sufficient degree of evacuated aqueous humor and to help facilitate reabsorption of aqueous humor to constitute an effective treatment for the patient.
In some alternative embodiments, an aqueous humor diffusion member may have a tubular or cylindrical profile that includes a plurality of concentrically located diffusion membranes. For example, an aqueous humor diffusion member may include a tubular constriction diffusion membrane and a tubular proliferation diffusion membrane, wherein the tubular constriction diffusion membrane corresponds to an inner diffusion membrane that is concentric with the membrane. proliferation diffusion, which defines an exterior of the aqueous humor diffusion member. Turning to Figure 8, a glaucoma drainage system 8000 is shown and includes an aqueous humor diffusion member 8002 that is defined by an 8100 outer tubular proliferation diffusion membrane that is concentric with a tubular constriction diffusion membrane. internal 8200. A portion of the aqueous humor diffusion member 8002 is shown cut away to expose the interior region of the aqueous humor diffusion member 800. As shown, a reservoir 8010 is defined within a central lumen of the internal tubular constriction diffusion membrane 8200, and a fluid conduit 8500 is fluidly coupled with reservoir 8010 at a second end 8006 of the diffusion member. aqueous humor 8002. In some embodiments, the concentric diffusion membranes of the aqueous humor diffusion member 8002 shown in Figure 8 may be uncoupled or partially uncoupled from each other, as indicated herein. In some embodiments, at least one end (eg, first end 8004 that is opposite fluid conduit 8500) of aqueous humor diffusion member 8002 is sealed to cause evacuated aqueous humor to leak through the membranes of Concentric diffusion of the aqueous humor diffusion member 8002.
As noted above, in various embodiments, the fluid conduit is a soft, flexible tubular member that can be inserted into the anterior chamber of the eye. In general, regardless of the specific surgical strategy adopted by the physician, one or more of the fluid conduit and aqueous humor diffusion member will be advanced or pushed during the implantation procedure. The soft, thin and flexible components are generally difficult to advance through tissue during implantation procedures. Accordingly, in various embodiments, the glaucoma drainage systems discussed herein can further include a reinforcing member that is removably integrated with the glaucoma drainage systems. The removable reinforcing member operates with the fluid conduit to temporarily form an installation assembly having a column resistance greater than the column resistance of the fluid conduit.
Furthermore, while the glaucoma drainage systems discussed herein include aqueous humor diffusion members and are described to include one or more diffusion membranes that are permeable to biological fluids (eg, aqueous humor) and that are configured to allow growth into the tissue as well as one or more diffusion membranes that are permeable to biological fluids (e.g. aqueous humor) and which are configured to resist tissue ingrowth, it should be understood that the reinforcing members mentioned herein be used with any soft and flexible fluid conduit to form an installation assembly having a column resistance greater than the column resistance of the fluid conduit. That is, while the reinforcing members described herein may be configured for use with any of the various glaucoma drainage systems described herein, it should be understood that the reinforcing members described herein are not limited to the systems having aqueous humor diffusion members that include one or more diffusion membranes that are permeable to biological fluids (e.g., aqueous humor) and that are configured to allow growth into tissues, and one or more diffusion membranes that are permeable to biological fluids (e.g., aqueous humor) and that are configured to resist growth into the interior of the tissue.
Looking at Figure 9A, Figure 9B, and Figure 9C, various glaucoma 9000 drainage systems are shown that include one or more reinforcing members, such as the 9700 reinforcing member, to help manage the glaucoma drainage system. 9000 glaucoma. The 9000 glaucoma drainage system includes a 9500 fluid conduit and a 9002 body. Body 9002 is configured to receive a biological fluid, such as aqueous humor, that has been evacuated through fluid conduit 9500. Therefore, while body 9002 may correspond in construction, shape, and composition to any of several aqueous humor diffusion members (eg, such as aqueous humor diffusion member 1002), it should be understood that the body 9002 may alternatively correspond to any suitable device configured to receive a biological fluid that has been evacuated through fluid conduit 9500. That is, the reinforcing members do not require that the body 9002 include one or more diffusion membranes that are permeable to biological fluids and that are configured to allow growth into the tissue, as well as one or more diffusion membranes that are permeable to biological fluids and are configured to resist growth into tissue
Referring specifically to FIG. 9A, the glaucoma drainage system 9000 may include a helically wound reinforcing member 9700 that helps to deliver the glaucoma drainage system 9000 to the eye. Reinforcing member 9700 includes an elongated removable member that extends into fluid conduit 9500. As shown, the reinforcing member 9700 is wound onto a helical coil, the construction of which functions to provide greater axial, lateral, and radial stiffness, while maintaining some lateral flexibility so that the fluid conduit 9500 can be flexed or manipulated. otherwise to a position within a fluid-filled body cavity, such as the anterior chamber of a patient's eye. In particular, said helical configuration of the reinforcement member 9700 provides that the reinforcement member 9700 can be axially compressed along a longitudinal axis of the helical coil, while providing some column strength. Axial compression is achieved by adjacent loops or windings of the helical coil that hook together and react with each other as the helical coil is compressed. Thus, in the examples where the reinforcing member 9700 is located within the fluid conduit 9500, these adjacent loops or windings of the helical coil are configured to engage with each other and react with each other when the fluid conduit 9500 is coupled. compresses. The helical configuration of the reinforcement member 9700 also allows the reinforcement member 9700 to have some lateral stiffness, without being too stiff. Lateral flexibility is achieved by adjacent loops or winding of the helical coil being able to translate and / or skew slightly relative to each other as lateral force is applied to reinforcing member 9700. Thus, in the examples where the reinforcement member 9700 is located within the fluid conduit 9500, the adjacent loops or windings of the helical coil of the reinforcement member 9700 are configured to translate and / or incline slightly relative to each other. to the other as lateral force is applied to fluid passage 9500, to
Lzomn / n ^ nz / q / Yi allow some flexing of the fluid conduit 9500. Radial stiffness is achieved by ring strength of the helical windings of the helical coil. Thus, in examples where the reinforcing member 9700 is located within the fluid conduit 9500, the ring strength of the helical windings can help provide the fluid conduit 9500 with temporarily increased ring strength.
In various embodiments, the stiffening member 9700 includes a first end 9702 and a second end 9704 as shown in Figure 9A. When disposed within fluid conduit 9500, first end 9702 of reinforcement member 9700 extends from first end 9502 of fluid conduit 9500. Second end 9704 of reinforcement member 9700 terminates within glaucoma drainage system 9000 . As shown in Figure 9A, in some embodiments, the portion of the reinforcing member 9700 that extends within the fluid conduit 9500 is helically wound. In some embodiments, the portion of the reinforcing member 9700 that extends from the first end of the fluid conduit 9500 is unwound, as shown.
In some embodiments, the second end 9704 of the stiffening member 9700 extends to a position within the fluid conduit 9500, such as proximal to the second end 9504 of the fluid conduit. In some embodiments, the second end 9704 of the stiffening member 9700 extends from the second end 9504 of the fluid conduit 9500 to a position within the body 9002 of the glaucoma drainage system 9000. For example, in some embodiments, the second end 9704 of the reinforcing member 9700 extends from the second end 9504 of the fluid conduit 9500 to a position between adjacent diffusion membranes.
The reinforcing member 9700 can include one or more fibers (such as structures that have minimal or relatively minimal column resistance), one or more cables (such as structures that exhibit some column resistance), or a combination of fibers and cables. . In some embodiments, the reinforcing member can include silicone, ePTFE, polycarbonate, polyethylene, polyurethane, polysulfone, PVDF, PHFP, PFA, polyolefin, FEP, acrylic copolymers and other suitable fluoro copolymers, or any other suitable polymer, or metallic components, such as stainless steel or nitinol (straight or stranded). It will be understood that the material properties of the reinforcing material and / or gauge can be varied to produce reinforcing members of a desired axial, lateral and / or radial stiffness. In other embodiments, the reinforcing member may additionally or alternatively be formed of a removable or alternatively absorbed material.
Incorporation of reinforcing member 9700 into the smooth, thin, and flexible structure that forms fluid conduit 9500 provides that fluid conduit 9500, in combination with reinforcing member 9700, can advance through or advance between one or more tissues. That is, in addition to or as an alternative to passing through or being pulled between one or more tissues, the fluid conduit 9500, in combination with the reinforcing member 9700, can advance through or advance between one or more tissues. For example, such a configuration provides that the 9500 fluid conduit of the 9000 glaucoma drainage system can be advanced between the scleral and conjunctival tissue, as well as advanced through a perforation, incision or hole in the sclera and into an anterior chamber. (CA) of a patient's eye. In some examples, the fluid conduit 9500, in combination with the reinforcing member 9700, can be held, for example with a clamping device, by a physician implanting the glaucoma drainage system 9000 and can be advanced to a position wherein the first end 9502 of the fluid conduit 9500 is located within an anterior chamber (CA) of a patient's eye.
In some embodiments, after the fluid conduit is advanced into the anterior chamber, the reinforcing member 9700 is accessed and removed from the fluid conduit using a front clear corneal approach. For example, after device placement and insertion into the anterior chamber, a small incision is made near the limbus of the clear cornea. The clinician may enter the anterior chamber with one or more small fasteners to engage the exposed end of the removable reinforcement member 9700 to facilitate removal of the reinforcement member 9700 from the fluid conduit 9500. Such small corneal incisions generally do not require closure. suture. In embodiments involving a rolled reinforcing member, such as reinforcing member 9700, the reinforcing member can uncoil, partially uncoil, or remain coiled during extraction.
In various embodiments, the backing member 9700 can be removed from the fluid conduit 9500. The backing member 9700 can be removed from the fluid conduit 9500 after the practitioner has installed the glaucoma drainage system 9000, or at least after that one end (such as first end 9502) of fluid conduit 9500 has advanced into an anterior chamber or other fluid filled body cavity. In some embodiments, the stiffening member 9700 is removed from the evacuation chamber by pulling one end of the stiffening member 9700, such as one end of the stiffening member 9700 proximate the end of the fluid conduit projecting or positioned within the anterior chamber when the 9000 Glaucoma Drainage System is implanted. In various embodiments, an application of tension to the first end 9702 of the reinforcement member 9700 causes the successive helical winding of the reinforcement member 9700 to unravel. In various embodiments, as the reinforcing member 9700 progressively unravels, it is withdrawn or removed from the fluid conduit 9500 as illustrated in Figure 9B. In some embodiments, untangling the reinforcing member 9700 causes the axial length of the reinforcing member to increase. For example, when in a spiral configuration, reinforcing member 9700 has a first axial length, and when unraveled in an unrolled configuration, reinforcing member 9700 has a second axial length that exceeds the first axial length. In some embodiments, unwinding or unraveling reinforcing member 9700 causes a reduction in an effective diameter of reinforcing member 9700. For example, when in a spiral configuration, reinforcing member 9700 has a first effective diameter based on a diameter of the windings, and when unraveled in an unwound configuration, reinforcing member 9700 has a second effective diameter based in a diameter of the element (eg, fiber) from which the reinforcing member 9700 is formed, wherein the second effective diameter is less than the first effective diameter. Therefore, it should be understood that reinforcing member 9700 is easier to remove from fluid conduit 9500 when unraveled or unwound than reinforcing member 9700 when wound due to the reduction in effective diameter from the first effective diameter to the second. effective diameter.
In some embodiments, instead of a stiffening member located within the lumen of the fluid conduit, a stiffening member may be provided around an exterior of one or more portions of the glaucoma drainage system 9000, such as, for example , around an exterior of the fluid conduit 9500. For example, as shown in Figure 9C, the reinforcing member 9700 is shown disposed and extending along an exterior of the fluid conduit 9500.
In some such embodiments, the Glaucoma Drainage System 9000 includes or is otherwise associated with a delivery system that includes a needle-shaped insertion tool / injector that has sufficient spinal or other mechanical stiffness to facilitate delivery. administration of the fluid conduit and / or other components of the Glaucoma Drainage System 9000 to the eye. In some embodiments, the needle-shaped injector / insertion tool is disposed at least around the fluid conduit, which facilitates placement of the fluid conduit 9500 in the anterior chamber (CA).
Again referring to Figure 9D, in some embodiments, the glaucoma drainage system 9000 includes a plurality of reinforcement members, such as a first reinforcement member 2100 and a second reinforcement member 2200. As shown, the first member Reinforcement 2100 extends into fluid conduit 9500 and includes a first end 2102 and a second end 2104. The first end 2102 extends from the first end 9502 of the fluid conduit 9500, and may terminate at some position within the fluid conduit 9500 as long as the first reinforcing member 2100 can be subsequently accessed and removed. As shown in Figure 9D, the second end 2104 of the first stiffening member 2100 extends to an interior position towards or within the glaucoma drainage system 9000. Although not shown, in some embodiments, the first stiffening member 2100 may extend to a position proximate the second end 9504 of the fluid conduit. In other embodiments, the second end 2104 of the first reinforcing member 2100 may extend from the second end 9504 of the fluid conduit 9500 to a position between adjacent layers, membranes, or strata of the glaucoma drainage system 9000. As shown in Figure 9D, the second end 2104 of the first reinforcement member 2100 extends to a position within the body 9002. In some embodiments, the second end 2104 of the first reinforcement member 2100 can extend to a position within the body. 9002 between adjacent diffusion membranes.
Similar to the aforementioned reinforcing member 9700, the first reinforcing member 2100 can be operated as a mechanism to advance or push the smooth, thin, and flexible structure that forms the fluid conduit 9500 between one or more tissues. Thus, in some embodiments, the stiffening member 2100 may be operated to help advance the fluid conduit 9500 of the glaucoma drainage system 9000 to a target delivery position, such as between the conjunctival and scleral tissue. In some embodiments, after the fluid conduit 9500 and body 9002 are positioned within the subconjunctival cavity so that the first end 9502 of the fluid conduit 9500 is positioned to advance into the fluid-filled body cavity, the first reinforcing member 2100 can be removed from the glaucoma drainage system 9000 and discarded. Removal of the first reinforcing member 2100 from the glaucoma drainage system 9000 may alternatively occur after the fluid conduit 9500 from the glaucoma drainage system 9000 is properly positioned within the fluid-filled body cavity.
In addition to the first backing member 2100, the glaucoma drainage system 9000 shown in Figure 9D includes a second backing member 2200. As shown, the second backing member 2200 extends into a portion of the fluid conduit 9500 and includes a first end 2202 and a second end 2204. As shown in Figure 9D, first end 2202 extends from first end 9502 of fluid conduit 9500. However, it should be understood that the first end 2202 may terminate at some position within the fluid conduit 9500.
In some embodiments, the stiffening member 2200 extends through a wall of the fluid conduit 9500. For example, in some embodiments, the fluid conduit 9500 includes an opening 9510, and the stiffening member 2200 extends through the opening 9510 of the fluid conduit 9500. As shown in Figure 9D, the second end 2104 of the first stiffening member 2100 extends outside the fluid conduit 9500 such that the stiffening member 2200 extends through the opening 9510 in the fluid conduit 9500. In various embodiments, opening 9510 is located between first and second ends 9502 and 9504 of fluid conduit 9500. In some embodiments, the opening 9510 is located closer to the first end 9502 than it is to the second end 9504. That is, in some embodiments, the opening 9510 is located closer to the end of the fluid conduit that is configured to be positioned within a cavity. fluid-filled body than one end of fluid conduit 9500 engaged with body 9002. In some embodiments, by positioning the opening 9510 closer to the first end 9502 of the fluid conduit 9500 than the second end 9504, the opening 9510 can be positioned such that the opening 9510 is positioned within the fluid-filled cavity (e.g. , the anterior chamber of the eye) when the 9000 Glaucoma Drainage System is implanted. Such a configuration provides that opening 9510 does not offer a path for fluid traveling through fluid conduit 9500 to leak from there. However, it should be understood that aperture 9510 may alternatively be positioned closer to second end 9504 than first end 9504, or it may be positioned equidistant between first end 9502 and body 9002.
As mentioned above, the second reinforcement member 2200 includes a second end 2204 that extends from the opening 9510 in the fluid conduit 9500. During implantation of the glaucoma drainage system 9000, the second reinforcement member 2200 may be used to advance the first end 9502 of the fluid conduit 9500 to a position within the fluid-filled body cavity (eg, the anterior chamber of the eye). For example, the physician can manipulate the second reinforcing member 2200 and use it to guide the first end 9502 of the fluid conduit 9500 into a preformed penetration tract through tissue in a fluid-filled body cavity.
In some embodiments, in addition to facilitating advancement of the fluid conduit 9500 through a preformed incision in a tissue of a fluid-filled body cavity, the second reinforcing member 2200 may be used to form the puncture in the tissue (e.g., scleral tissue) to access the fluid-filled body cavity (for example, the anterior chamber of the eye). That is, instead of making an incision or piercing the tissue with a separate instrument, the reinforcing member 2200 can be configured so that it can be used to penetrate the tissue and access the fluid-filled body cavity within which the device will be placed. fluid conduit 9500. For example, in some embodiments, the first end 2202 of the reinforcing member 2200 includes a pointed or pointed tip that is configured to pierce tissue, such as scleral tissue.
Devices suitable for attaching fluid conduit 9500 to first and / or second reinforcing members 2100 and 2200 include, but are not limited to, biocompatible ties, sutures, closures, and / or adhesives that are soluble in biological fluids, such as aqueous humor. In some embodiments, a diameter of the first and / or second reinforcement members 2100 and 2200 can be narrowed such that the diameter exceeds a diameter of the fluid conduit 9500, which minimizes or even prevents the first and / or second reinforcement members from advance into fluid conduit 9500 beyond a designated amount, due to interference between first and / or second reinforcing members 2100 and 2200 and fluid conduit 9500. However, it should be understood that in such embodiments, the first and / or second reinforcement members 2100 and 2200 are removable or retractable from the fluid conduit 9500 without also causing a withdrawal of the fluid conduit 9500. In some embodiments, the diameter of the first and / or second reinforcing members 2100 and 2200 can taper continuously or discontinuously. For example, in some embodiments, the first and / or second reinforcing member 2100 and 2200 may include one or more discrete regions, including a first region that has a first diameter and a second region that has a second diameter. In some embodiments, the transition between the first and second regions is configured such that the first and second regions are discrete regions. For example, the transition between the first and second regions may be in the form of a step that extends radially and perpendicularly to a longitudinal axis of the reinforcing member. In some other embodiments, the transition may alternatively be tapered or angled relative to the longitudinal axis of the reinforcing member. Such conical configurations provide that the first and / or second reinforcing member 2100 and 2200 releasably engage fluid conduit 9500 and can be removed from fluid conduit 9500 after advancing through tissue, such as after the fluid conduit 9500 has advanced through the sclera and into the anterior chamber of the eye.
In various embodiments, after the first end 9502 of the fluid conduit 9500 is placed within the fluid-filled body cavity, the second backing member 2200 can be removed from the glaucoma drainage system 9000 and discarded. In some embodiments, a physician may delay removal of the first reinforcing member 2100 until after the first end 9502 of the fluid conduit 9500 has been properly positioned within the fluid-filled body cavity.
As mentioned above, one of the first and second reinforcing members 2100 and 2200 can include or be formed of nylon, polyether ether ketone ("PEEK"), polyimide, polycarbonate, polyethylene, polyurethane, PVDF, polyolefin. , acrylic copolymers or any other suitable polymer, or metallic components, such as stainless steel, nitinol or other biocompatible alloy (straight or braided). The properties of the reinforcing material and / or gauge can be varied to produce reinforcing members of desirable axial, lateral and / or radial stiffness, as will be understood by those skilled in the art. In some embodiments, an outer surface of at least one of the first and second reinforcement members 2100 and 2200 may be textured to provide better traction of the fluid conduit 9500 with the respective reinforcement member.
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The novel concepts of this application have been described above generically and with respect to specific modalities. It will be apparent to those skilled in the art that various modifications and variations in modalities can be made without departing from the scope of the description. Therefore, the modalities are intended to cover such modifications and variations as long as they fall within the scope of the appended claims and their equivalents.
In various embodiments, the fluid passages of the various glaucoma drainage systems discussed herein can be configured to include multiple lumens. Therefore, while the aforementioned embodiments related to bracing members are illustrated and described in association with single-lumen fluid conduits, it should be understood that the glaucoma drainage systems discussed herein may include a conduit of multi-light fluid conduit and may include one or more reinforcing members removably integrated with one or more of the lights of the multi-light fluid conduit, to temporarily form an installation assembly with a column resistance greater than the column resistance of the multi-lumen fluid conduit.
In some embodiments, the glaucoma drainage systems discussed herein can be implanted AB internally (eg, from inside the eye), such as through an incision in the clear cornea, and placed through the sclera and into a space dissected subconjunctival, as will be understood by those skilled in the art. In some other embodiments, glaucoma drainage systems can be implanted AB externally (eg, from outside the eye), such as through a conjunctival incision, as should be understood by those of skill in the art. In some embodiments, a radial conjunctival incision is made typically near the limbal junction, and a blunt dissection of the conjunctiva is performed to expose the sclera and provide a site for placement of the aqueous humor diffusing member. In some embodiments, this may require suturing the aqueous humor diffusion member to the sclera. In some embodiments, a small needle, typically a 22 or 23 gauge needle, is also inserted near the scleral spur to provide a path for subsequent insertion and placement of the fluid conduit into the anterior chamber.
As noted above, in various embodiments, the aqueous humor diffusion members mentioned herein are formed of a plurality of diffusion membranes including a proliferation diffusion membrane and a constriction diffusion membrane, wherein the porosity or Aqueous humor permeability of the proliferation diffusion membrane exceeds the porosity of the constriction diffusion membrane. Thus, the disclosed aqueous humor diffusion members comprise a plurality of different membranes having different degrees of porosity (eg, different amounts of pores and / or pores having different sizes). Generally, different diffusion membranes having different degrees of porosity will be associated with different rates at which aqueous humor diffuses into the associated membrane (also described as flow rates). For example, the aqueous humor diffusion member can be configured so that an amount of aqueous humor diffuses into the constricting diffusion membranes at a different rate (eg, a lower flow rate) than the amount of humor Aqueous diffuses into proliferating diffusion membranes (eg, increased flow rate). Therefore, the aqueous humor diffusion member can be configured so that the aqueous humor diffuses into a first region of the aqueous humor diffusion member at a different rate than the aqueous humor diffuses into a second region of the member. diffusion of aqueous humor.
As noted above, in various embodiments, the layers of polymeric material (s) that make up the diffusion membranes can be coupled together at one or more discrete locations to form stabilizing structures that extend through the diffusion membrane. diffusion. In some embodiments, during a lamination process, the various layers that make up the diffusion membrane can be laminated together so that one or more discrete pillar or column structures extend through the diffusion membrane from a first interface surface of the diffusion membrane. the diffusion membrane to a second surface interface of the diffusion membrane. In various embodiments, these pillar or column-like structures can be formed of adhesives. In some embodiments, one or more of these abutments can effectively hold an interface open or otherwise maintain an effective deformable, shear, and slidable interface, such that the glaucoma drainage device is flexible and can be operated to accommodate aqueous humor. evacuated. Additionally, in some embodiments, inadvertent expansion (eg, dilation) of the aqueous humor diffusion member beyond a designated amount or beyond a designated profile can be minimized and / or avoided by discreetly bonding adjacent facing interface surfaces. of adjacent located diffusion membranes, as mentioned above.
As mentioned above, in various embodiments, the fluid conduit and / or the body of the aqueous humor diffusion member can be formed from soft and flexible materials to create a construction that conforms to the curvature of the eye, which helps minimize relative movement between glaucoma drainage systems and surrounding tissue that can cause tissue irritation, tissue response to foreign body, excessive scarring, and / or erosion. Another potential problem experienced with conventional designs includes erosion of the fluid conduit through the conjunctiva, generally proximal to the region where the fluid conduit passes through the sclera and extends into the anterior chamber of the eye. Conjunctival erosion in this way can lead to direct exposure of the anterior chamber, providing a pathway for bacteria to enter the eye, a risk of endophthalmitis, and possible loss of vision in the eye.
Although various strategies have been tried to minimize the potential for such erosion through the conjunctiva, none of the known solutions include a unique device or system that combines aqueous humor drainage while protecting against fluid conduit erosion.
Referring to Figure 10A, Figure 9B, Figure 9C and Figure 11, in various embodiments, a glaucoma drainage system 10000 includes an aqueous humor diffusion member 10002 and a fluid conduit 10500. The fluid conduit 10500 may be consistent with respect to construction, form, composition, and function with the various fluid conduits (eg, fluid conduit 1500) mentioned above. Similarly, the aqueous humor diffusion member 10002 can be consistent with respect to construction, form, composition and function with the various aqueous humor diffusion members (eg, aqueous humor diffusion member 1002) mentioned above, but with the exception that the aqueous humor diffusion member 10002 additionally includes one or more erosion elements 10600.
In various embodiments, an erosion element 10600 is an element, feature, component, or portion of the glaucoma drainage system 10000 that overlaps a portion of the fluid passage 10500 to help minimize erosion of the fluid passage 10500 through one or more tissues of the eye when the Glaucoma Drainage System 10000 is implanted. As noted above, in various embodiments, the Glaucoma Drainage System 10000 can be implanted within a pocket formed between the conjunctiva and the sclera of the eye, as will be understood by those of skill.
In some cases, for example, the erosion element 10600 extends from the body of the glaucoma drainage system 10000 to overlap the fluid passageway 10500. The erosion element 10600 functions as a protective barrier between the fluid passageway 10500 and a or more surrounding tissues of the eye. For example, the glaucoma drainage system 10000 can be configured such that an erosion element 10600 extends along the fluid passage 10500 between the fluid passage 10500 and a conjunctiva of the eye when implanted. In some such embodiments, the erosion element 10600 helps to minimize or even prevent erosion of the fluid conduit 10500 through the conjunctiva by forming a barrier between the fluid conduit 10500 and the conjunctiva when the glaucoma drainage device 10000 it is implanted in the eye, as indicated below.
In some embodiments, the erosion element 10600 forms an integral, non-separable element, feature, component, or portion of the glaucoma drainage system 10000. In some other embodiments, the erosion element 10600 is formed as a distinct element or component that is coupled with one or more portions of the 10000 Glaucoma Drainage System. In some such embodiments, the erosion element 10600 may be coupled with one or more portions of the glaucoma drainage system 10000 and thus become an integral part of the glaucoma drainage system 10000. Alternatively, in some embodiments, the erosion element 10600 can be coupled with one or more portions of the glaucoma drainage system 10000 such that the erosion element 10600 can subsequently be detached and removed from the glaucoma drainage system 10000.
As noted above, the glaucoma drainage system 10000 may include multiple (or a plurality of) erosion elements 10600. In some such embodiments, the fluid conduit 10500 of the glaucoma drainage system 10000 may be isolated from interface with the surrounding tissue of the eye (eg, a sclera or conjunctiva) by incorporating multiple elements of erosion 10600. That is, in some embodiments, the glaucoma drainage system 10000 may include one or more erosion elements 10600 that isolate the fluid conduit 10500 of the glaucoma drainage system 10000 from the tissue of the eye. For example, glaucoma drainage system 10000 can be configured such that erosion elements 10600 flank fluid passage 10500 on either side of a plane that bisects fluid passage 10500 along a longitudinal axis thereof. In such a configuration, for example, one of the erosion elements 10600 may extend along the fluid conduit 10500 between the fluid conduit 10500 and a sclera of the eye. Similarly, a second erosion element 10600 may extend along fluid conduit 10500 between fluid conduit 10500 and a conjunctiva of the eye. Such a configuration provides protection against erosion for both the conjunctiva and the sclera of an eye when the Glaucoma Drainage Device 10000 is implanted in the eye (for example, when it is implanted within a pocket formed between the conjunctiva and the sclera). as the fluid conduit 10500 is prevented from interacting directly with the conjunctiva and sclera of the eye.
As mentioned above, with the exception of the erosion element 10600, the glaucoma drainage system 10000 is similar with respect to construction, shape and composition to the other glaucoma drainage systems mentioned herein (for example, the glaucoma drainage system glaucoma drainage system 1000). Therefore, in various embodiments, the glaucoma drainage system 10000 comprises a multilayer construction and is configured to help drain aqueous humor from the anterior chamber of the eye by facilitating not only the evacuation of aqueous humor from within the chamber. anterior of the eye, but also the reabsorption of the aqueous humor evacuated by the body, for example. Like the Glaucoma Drainage System 1000, in various embodiments, the Glaucoma Drainage System 10000 similarly includes one or more constricting diffusion membranes and one or more proliferation diffusion membranes arranged to optimize drainage and reabsorption of aqueous humor (as mentioned above).
In various embodiments, the erosion element 10600 includes a thin, flexible, porous membrane consisting of construction, shape, and composition with the other thin, flexible, and porous membranes mentioned herein (eg, the diffusion membranes mentioned above). For example, the erosion element 10600 may include a microstructure that is configured to resist growth into tissue (eg, a constricting diffusion membrane), or may alternatively include a microstructure that is configured to promote or allow growth into tissue (eg, proliferation diffusion membrane). Alternatively, in some embodiments, the erosion element 10600 may comprise a multilayer construction that includes a first membrane configured to promote or allow growth into tissue (eg, proliferation diffusion membrane) and a second membrane configured to resist growth into the tissue or growth into the cell (eg, a constricting diffusion membrane). The permissive / resistive membranes in such modalities are oriented to optimize their effect when the glaucoma drainage device 10000 is implanted in the eye. For example, as discussed in more detail below, in various embodiments, the erosion element 10600 is configured to promote or allow tissue ingrowth along an interface between the erosion element 10600 and a tissue of the eye (for example, the sclera or conjunctiva). Therefore, it will be understood that the material of the erosion element 10600 can include any material and can be constructed according to any method mentioned herein as suitable for the diffusion membranes mentioned above.
Accordingly, in various embodiments, the erosion element 10600 may be coupled with (or alternatively may be an extension of or integral with) any of the various proliferation diffusion membranes or constriction diffusion membranes mentioned herein. Thus, in some embodiments, the erosion element 10600 may be a constricting diffusion membrane (e.g., configured to minimize, resist, or prevent growth into tissue) or a proliferation diffusion membrane (e.g. , configured to allow growth into the tissue). In some such embodiments, the erosion element 10600 is a constriction diffusion membrane coupled or integral with a constriction diffusion membrane of the aqueous humor diffusion member. Additionally or alternatively, in some embodiments, the erosion element 10600 is a constriction diffusion membrane coupled to a proliferation diffusion membrane of the aqueous humor diffusion member. In some embodiments, the erosion element 10600 is a proliferation diffusion membrane coupled to a constriction diffusion membrane of the aqueous humor diffusion member. In some embodiments, the erosion element 10600 is a proliferation diffusion membrane coupled or integral with a proliferation diffusion membrane of the aqueous humor diffusion member.
Referring to Figure 10A, Figure 9B, Figure 10C and Figure 11, a glaucoma drainage system 10000 is shown. Figure 10A is a top view of the glaucoma drainage system. Figure 10B is a cross-sectional view of the 10000 glaucoma drainage system taken along line 10B-10B in Figure 10A. Figure 10C is a cross-sectional view of the 10000 glaucoma drainage system taken along line 10C-10C in Figure 10A. Figure 11 is an exploded view of the 10000 glaucoma drainage system.
As shown, the glaucoma drainage system 10000 includes an aqueous humor diffusion member 10002, a fluid conduit 10500 (eg, a shunt), and an erosion element 10600. The aqueous humor diffusion member 10002 includes a plurality of layers including a first layer 10010 and a second layer 10020. Each of the first and second layers 10010 and 10020 include one or more diffusion membranes configured to promote or allow growth into tissue (eg, proliferation diffusion membrane) and / or one or more diffusion membranes configured to resist growth into tissue (eg, a constricting diffusion membrane). Therefore, it will be understood that the first layer 10010 may be composed of one or more diffusion membranes configured to promote or allow growth into the tissue and one or more diffusion membranes configured to minimize, resist or prevent growth towards inside the fabric. Similarly, it will be understood that the section layer 10020 may be additionally or alternatively formed by one or more diffusion membranes configured to promote or allow growth into the tissue and one or more diffusion membranes configured to minimize, resist or prevent growth into the tissue. Therefore, it will be understood that the aqueous humor diffusion member 10002 may be similar with respect to construction, shape and function to the other aqueous humor diffusion members mentioned herein.
As shown in Figure 10A, Figure 10B, Figure 10C, Figure 11 and Figure 12, the glaucoma drainage system 10000 includes an erosion element 10600. The erosion element 10600 extends away from the diffusion member Aqueous humor 10002 from the Glaucoma Drainage System 10000 as shown. In some embodiments, the i zarnn / nznz / zi / Yl erosion element 10600 extends away from the aqueous humor diffusion member 9002 along the fluid conduit 10500 between the fluid conduit 10500 and the humor diffusion member. aqueous 10002. In some embodiments, the erosion element 10600 extends between the aqueous humor diffusion member 10002 and an end of the fluid conduit 10500 (eg, a first end or a second end of the fluid conduit 10500) that is configured to access to a body cavity filled with biological fluid, such as the anterior chamber of an eye, among other modalities that will be understood by those skilled in the art.
Although Figure 10A, Figure 9B, Figure 10C and Figure 11 are shown to include a rectangular shape, it will be understood that the erosion element 10600 may have any suitable shape without departing from the spirit or scope of the description. For example, the erosion element 10600 can be square, rectangular, trapezoidal, or some other polygonal shape, and can include beveled or rounded edges between the sides, and the sides can be linear or generally curved in nature. Erosion member 10600 may have a generally continuous curved edge in that it is circular or ovular, or otherwise suitable (eg, bean-shaped). It should be understood that one of skill in the art will understand that the erosion element 10600 may have any desired shape, as long as the erosion element 10600 helps protect against fluid conduit erosion through the tissue surrounding the fluid conduit and always that the erosion element 10600 can be positioned within a subconjunctival space (such as a pocket formed between the conjunctiva and the sclera) as described herein.
In some embodiments, the erosion element 10600 extends along a length of the fluid conduit, but includes a length that is shorter than a length of the portion of the fluid conduit that extends from the humor diffusion member. aqueous 10002. In other embodiments, the erosion element 10600 extends along a length of the fluid conduit, and includes a length that is equal to or greater than the length of the portion of the fluid conduit extending from the diffusion member of aqueous humor 10002. In some embodiments, the erosion element 10600 has a width that is greater than or equal to a diameter of the fluid conduit 10500. However, in some embodiments, the width of the erosion element 10600 may be less than the diameter of the fluid passage, as long as the erosion element 10600 does not become ineffective in helping to protect against erosion of the fluid passage through the surrounding tissue. In accordance with the versatility in suitable sizes and shapes of the aforementioned erosion element 10600, it will be understood that the width of the erosion element 10600 may remain constant along the erosion element 10600, or alternatively, the width of the erosion element 10600 it can vary along the erosion element 10600. For example, the width can decrease (linearly or non-linearly) along the longitudinal length of the erosion element.
In some embodiments, the erosion element 10600 can be configured to be more resistant to abrasion in areas of high wear or high abrasion (for example, areas where the fluid conduit 10500 has a potential to move relative to the plate. erosion 10600). Resistance to abrasion in such areas can be achieved according to any known method, including material compositions and / or material thickness. Therefore, a thickness of the erosion element 10600 can vary along the length of the erosion element 10600, and / or can vary laterally along its width. For example, the thickness can decrease (linearly or non-linearly) along the length of the erosion element 10600 and / or transversely through it. For example, a thickness of the erosion element 10600 along a longitudinally extending center line may be greater than a thickness of the erosion element 10600 along one or more of its longitudinally extending edges. Alternatively, it will be understood that a thickness of the erosion element 10600 along a longitudinally extending center line may be less than a thickness of the erosion element 10600 along one or more of its longitudinally extending edges. Additionally or alternatively, a thickness of the erosion element 10600 along one section of its longitudinal length may be greater than a thickness of the erosion element 10600 along a second section of its longitudinal length. For example, if a region where the fluid conduit 10500 accesses the fluid-filled body cavity corresponds to a region of high abrasion, a section of the erosion element 10600 that is closest to the end of the fluid conduit 10500 that is configured to access the fluid-filled body cavity may be thicker than a section of the erosion element 10600 that is closer to the aqueous humor diffusion member 10002. It should be understood that a thickness of the erosion plate 10600 can be optimized in areas of high wear or high abrasion to reduce the risk of premature failure of the glaucoma drainage system 10000, due to abrasion of the erosion plate 10600 by the canal. fluid 10500. These variations in thickness can be achieved by the selective layering of materials that collectively form the erosion element 10600 or other known methods.
In some embodiments, the erosion element 10600 may be longitudinally spaced from the aqueous humor diffusion member 10002, or it may include a region of reduced width (eg, as illustrated in Figure 10) and / or thickness (no! luster) extending between the erosion element 10600 and the aqueous humor diffusion member 10002 along those regions of the fluid conduit 10500 that are associated with a low risk of erosion through the surrounding tissue. For example, if the portion of the fluid conduit 10500 adjacent to the aqueous humor diffusion member 10002 is associated with a low risk of erosion through the surrounding tissue, a region of reduced width and / or thickness of the erosion member 10600 may be located adjacent to this region of fluid conduit 10500. Alternatively, the erosion element 10600 can be configured so that the fluid conduit 10500 is exposed to the surrounding tissue in this low erosion risk region. Therefore, in some examples, the erosion element 10600 may not extend from the aqueous humor diffusion member 10002.
In some embodiments, the erosion member 10600 is coupled to the fluid conduit 10500. The erosion member 10600 may be coupled to the fluid conduit 10500 continuously along a length of the fluid conduit 10500, or alternatively along the conduit of 10500 fluid in one or more discrete locations. Erosion member 10600 may be coupled to fluid conduit 10500 in accordance with any known method, including, but not limited to, suturing or stitching the eroding member along the length of the conduit. In some embodiments, the suture can be a series of interrupted sutures or a continuous stitch. Additionally or alternatively, fluid conduit 10500 can be mechanically adhered to erosion element 10600 by partially fusing fluid conduit 10500 into the microporous structure of erosion element 10600. In some embodiments, erosion element 10600 can be coated with an adhesive that is tacky so that fluid conduit 10500 can releasably adhere to erosion member 10600. In some embodiments, one or more webs of material (eg, microporous material) may have their ends adhered to erosion element 10600 so that an eyelet is formed between the web of material and erosion element 10600 and the fluid conduit. 10500 can be threaded through the hole.
As stated above, when used to treat conditions such as glaucoma, the Glaucoma Drainage System 10000 can be located within a subconjunctival space (eg, a pocket formed between the conjunctiva and the whites of the eye). The glaucoma drainage system 10000 is positioned so that it assumes a relatively flat and minimal radial profile within the subconjunctival space, and so that the anterior chamber of the eye can be accessed via the fluid conduit 10500. Referring now to Figure 11 and Figure 12, glaucoma drainage systems are illustrated in implanted configurations. Figure 12 includes a glaucoma drainage system 10000 having an aqueous humor diffusion member 10002, a fluid conduit 10500 and an erosion element 10600. Figure 13 includes a glaucoma drainage system 10000 having a member of aqueous humor diffusion 10002, a fluid conduit 10500, and a plurality of first and second erosion elements 10600A and 10600B.
Referring to Figure 12, for example, the glaucoma drainage system 10000 is shown arranged in a subconjunctival space 2006 between the conjunctiva 2002 and the sclera 2004 of the eye 2000. The glaucoma drainage system 10000 is shown oriented in such a way that the first layer 10010 extends along the sclera 2004 and that the second layer 10020 extends along the conjunctiva 2002. It will be understood that the portion of the second layer 10020 that interacts with the conjunctiva 2002 can be configured to promote or allow growth into the tissue, as noted above. It will also be understood that the portion of the first layer 10010 that interacts with the sclera may be additionally or alternatively configured to promote or allow growth into the tissue, as noted above. Such configurations help minimize relative motion between aqueous humor diffusion member 10002 and surrounding tissue.
Additionally, fluid conduit 10500 is shown in Figure 12 extending from aqueous humor diffusion member 10002, and extending through a scleral access, perforation, or hole 2008 (for example, performed by a physician during the implantation procedure according to known methods) so that a first end 10502 accesses the anterior chamber (CA). Furthermore, as shown, the erosion element 10600 extends between the fluid conduit 10500 and the conjunctiva 2002 of the eye 2000. In particular, the erosion element 10600 extends between the fluid conduit 10500 and the conjunctiva 2002 in such a way that a portion of the erosion element 10600 is positioned adjacent or proximal to the scleral access 2008 and / or adjacent or proximal to the portion 10506 of the fluid conduit that extends through the scleral access 2008. Such a configuration provides that the conjunctiva 2002 is not directly exposed to the fluid conduit 10500. Instead, as shown, the erosion element 10600 extends the length of the conjunctiva 2002. This configuration helps protect against erosion of the fluid conduit. fluid 10500 through conjunctiva 2002, as erosion element 10600 operates as a protective barrier between conjunctiva 2002 and fluid conduit 10500. For example, the erosion element 10600 operates as a protective barrier between the fluid conduit and a portion 2010 of the conjunctiva positioned adjacent or proximal to the scleral access 2008, as shown.
It will be understood that the portion of the erosion element 10600 that interacts with the conjunctiva 2002 may be configured to promote or allow growth into tissue, as noted above. Such a configuration helps to minimize relative movement between the erosion element 10600 and the conjunctiva, even when there may be relative movement between the fluid conduit 10500 and the erosion element 10600.
Although the erosion element 10600 is shown in Figure 12 as a portion that extends beyond the scleral access 2008 (and thus the portion of the fluid conduit 10500 that extends through the scleral access), in some modalities, the erosion element 10600 may extend up to or even less than the scleral access
2008, as long as the erosion element 10600 is not ineffective against erosion protection.
In some embodiments, when implanted, the aqueous humor enters the first end 10502 of the fluid conduit 10500 and travels to a second end 10504 of the fluid conduit in fluid communication with the aqueous humor diffusion member 10002. In some embodiments, the second end 10504 is positioned within the aqueous humor diffusion member 10002 in the same manner as indicated above with respect to the second end 1504 of the fluid conduit 1500 and the aqueous humor diffusion member 1002. In accordance with the above, the evacuated aqueous humor enters a defined reservoir within aqueous humor diffusion member 10002 and is filtered through the various diffusion membranes of aqueous humor diffusion member 10002, wherein the aqueous humor it can then be absorbed by surrounding tissue and / or growing inward.
Looking at Figure 13, a 10,000 glaucoma drainage system is shown arranged in a 2006 subconjunctival space between the 2002 conjunctiva and the 2004 sclera of the 2000 eye. The 10000 Glaucoma Drainage System configuration shown in Figure 13 is similar to the 10000 Glaucoma Drainage System configuration shown in Figure 12, with the exception that the 10000 Glaucoma Drainage System shown in Figure 13 includes two erosion elements (eg, a first erosion element 10600A and a second erosion element 10600B). The first erosion element 10600A, corresponds in construction, form and function to the erosion element 10600 mentioned above with respect to Figure 12. It will be understood that while the glaucoma drainage system 10000 shown in Figure 13 includes the second erosion element 10600B in combination with the first erosion element 10600A, a glaucoma drainage system can include the second erosion element 10600B without requiring also the first erosion element 10600A. That is, in some embodiments, the glaucoma drainage system 10000 can be configured to include an erosion element that extends between the fluid passage 10500 and the sclera 2004 without also requiring an erosion element that extends between the fluid passage. 10500 and the conjunctiva 2002.
In addition, as shown in Figure 13, fluid conduit 10500 extends through opening 10602B of second erosion element 10600B before extending through scleral access, perforation, or hole 2008 (for example, performed by a physician during the implantation procedure according to known methods) and in the anterior chamber (CA). Therefore, it will be understood that in various embodiments, an erosion element (such as the second erosion element 10600B) may include one or more incisions, perforations, or openings that are configured to accommodate the fluid conduit 10500. In some embodiments, the second erosion element 10600B is constructed or manufactured with such a preformed opening. In some other embodiments, an incision, perforation, or opening may be formed in the erosion element during or just prior to the implantation procedure. In some modalities, the incision, perforation, or opening is formed by the physician or a physician's assistant.
As shown, the second erosion element 10600B extends between the fluid passage 10500 and the sclera 2004, while the first erosion element 10600A extends between the fluid passage 10500 and the conjunctiva 2002. Although the second erosion element 10600B shown in Figure 13 includes the opening 10602B and therefore a portion thereof that extends beyond the scleral access 2008, it will be appreciated that the second erosion element 10600B cannot extend up to scleral access 2008 or beyond, and therefore may not require a 10602B opening. In such configurations, the second erosion element 10600B may extend between the sclera 2004 and the fluid conduit 10500 to a position prior to the scleral access 2008 (not shown).
Configurations that include an erosion element that can be positioned between fluid conduit 10500 and sclera 2004 provide that sclera 2004 is not directly exposed to fluid conduit 10500. Such configurations help protect against erosion of fluid conduit 10500 throughout sclera 2004, as these erosion elements function as a protective barrier between sclera 2004 and fluid conduit 10500.
In some embodiments, the portion of the second erosion element 10600B that interacts with the sclera 2004 may be configured to promote or allow growth into the tissue, as noted above. Such a configuration helps to minimize relative movement between the second erosion element 10600B and the sclera 2004, even though there may be relative movement between the fluid conduit 10500 and the second erosion element 10600B.
In various embodiments, one or more portions of the glaucoma drainage systems discussed herein may include or be coated with one or more therapeutic agents, such as one or more glaucoma medications, as those of skill will understand. Additionally or alternatively, in various embodiments, one or more portions of the glaucoma drainage systems mentioned herein may include one or more markers to visually or electronically determine (e.g., radiopaque markers) to determine the proper placement of the glaucoma drainage system. glaucoma within the anatomy.
It should be understood that, in various embodiments, diffusion membrane materials may additionally or alternatively undergo one or more processes to remove trapped air within the various voids within the material (eg, denucleation).
These processes can be combined with one or more of the hydrophilic coating processes mentioned above. Trapped air can sometimes interfere with the wetting or saturation of the material with the aqueous humor, which could affect the efficiency with which the aqueous humor diffuses into the aqueous humor diffusion member and with which the body reabsorbs it. In some embodiments, trapped air can be removed by immersing the material in a series of baths. In some embodiments, these baths can progress from one or more alcohol baths to one or more sterile water baths.
Example 1
A medical device was constructed according to the following method. A lower sacrificial compression layer of thick distended PTFE tape was prepared by laser cutting a small coupon of distended PTFE tape. In particular, the shape of the laser cut glaucoma drainage device of the sacrificial PTFE layer corresponded to the shape of the first layer 9010 illustrated in Figure 10. All trimmings were removed, the sacrificial layer was aligned, and placed on a template plate configured to accommodate the small coupon. Next, a first coupon of microporous diffusion material (eg multilayer ePTFE) was placed over the small coupon of sacrificial PTFE material. The shape of the glaucoma drainage device was not laser cut in the first coupon of microporous diffusion material. The first coupon of microporous diffusion material was oriented such that the growth proliferation side into the tissue of the first coupon of microporous diffusion material was oriented downward and towards the sacrificial PTFE coupon.
Next, a layer of cling film (eg FEP) was prepared by laser cutting the shape of the glaucoma drainage device on the cling film identical in size and location to that made on the sacrificial PTFE coupon. Next, all the scraps were removed, and the cling film layer was aligned and placed on the microporous diffusion, ensuring that the cling film lay flat, without wrinkles or creases. Next, a second coupon of microporous diffusion material (eg multilayer ePTFE) was placed on the adhesive film. The shape of the glaucoma drainage device was not laser cut in the second coupon of microporous diffusion material. The second coupon of microporous diffusion material was oriented such that the tissue-inward growth proliferation side of the second coupon of microporous diffusion material was oriented upward and away from the adhesive film. Next, a top sacrificial compression layer of thick distended PTFE tape was placed over the second coupon of microporous diffusion material. The shape of the glaucoma drainage device was not laser cut into the upper sacrificial compression layer of thick distended PTFE tape. With this lamination stack configuration, the template was compressed so that the first and second coupons of
LZQrnn / nznz / q / Yi microporous diffusion material was uniformly compressed with the exception of the laser cut areas corresponding to the size and shape of the glaucoma drainage device. That is, with cutting the shape of the glaucoma drainage device made in the first lower sacrificial layer, only insufficient minimum force is applied to create a bond between the first and second coupons of microporous diffusion material in the area. corresponding in size and shape to the glaucoma drainage device. Similarly, because a cutout corresponding to the size and shape of the glaucoma drainage device was removed from the adhesive layer during the layering process, no adhesive film is applied to the corresponding areas of the first and second coupons. microporous diffusion material.
The stencil and placed layers were placed on a heated press plate, such as a desktop hot press, preheated to approximately 280 ° C, and compressed sufficiently for a designated period of at least 5 minutes to produce a bond. between the first and second coupons of microporous diffusion material and the adhesive film, while avoiding significant bonding of the laminate to the sacrificial layers. The laminate was then removed from the press and allowed to cool to room temperature.
The resulting laminate was laser cut to final size. In particular, the cutting line traced the shape of the glaucoma drainage device that was formed in the first sacrificial layer of PTFE, offset a short distance (~ 1mm) outward, so that the perimeter of the The shape of the device will include the portion of the first and second coupons of microporous diffusion material that are bonded together.
A fluid conduit consisting of a silicone tube was inserted between the uncompressed layers leading into the glaucoma drainage device, slightly separating the uncompressed layers and inserting the tube to a defined interior perimeter where the first and second coupons of microporous diffusion material. The tube was then secured to the glaucoma drainage device according to known methods.
Example 2
A medical device was constructed according to the following method. A lower sacrificial compression layer of thick distended PTFE tape was prepared by laser cutting a small coupon of distended PTFE tape. The shape of a glaucoma drainage device consistent with the above was laser cut from the small coupon and included approximately an 8mm circular dimension. In particular, the shape of the glaucoma drainage device laser cut from the small coupon corresponded to the shape of the second layer 9020 illustrated in Figure 10. That is, the shape of the glaucoma drainage device laser cut from of the small coupon included an ovular aqueous humor diffusion region and a rectangular erosion element consistent with the above description. All trimmings were removed, the sacrificial layer was aligned, and placed on a template plate configured to accommodate the small coupon. Next, a first coupon of microporous diffusion material (eg multilayer ePTFE) was placed over the small coupon of sacrificial PTFE material. The shape of the glaucoma drainage device was not laser cut in the first coupon of microporous diffusion material. The first coupon of microporous diffusion material was oriented such that the growth proliferation side into the tissue of the first coupon of microporous diffusion material was oriented downward and towards the sacrificial PTFE coupon.
Next, an adhesive file layer (e.g. FEP) was prepared by laser cutting the shape of the glaucoma drainage device, minus the feature of the rectangular erosion element, into the adhesive film of identical size and location (but with the exception of the characteristic of the rectangular erosion element) to that made in the PTFE sacrifice coupon. In particular, the shape of the adhesive film laser cut glaucoma drainage device corresponded to the shape of the first layer 9010 illustrated in Figure 10. Next, all the cutouts were removed, and the adhesive film layer was aligned. and was placed on the microporous diffusion, ensuring that the adhesive film lay flat, without wrinkles or folds. Next, a second coupon of microporous diffusion material (eg multilayer ePTFE) was placed on the adhesive film. The shape of the rectangular erosion element was laser cut into the second coupon of microporous diffusion material, identical in size and location to those made in the sacrificial PTFE coupon. Next, all cuttings were removed and the second coupon of microporous diffusion material was oriented such that the tissue-inward growth proliferation side of the second coupon of microporous diffusion material was oriented upward and away from the cling film.
Next, a top sacrificial compression layer of thick distended PTFE tape was placed over the second coupon of microporous diffusion material. The shape of the glaucoma drainage device was not laser cut into the upper sacrificial compression layer of thick distended PTFE tape. With this lamination stack configuration, the template was compressed so that the first and second coupons of microporous diffusion material were uniformly compressed with the exception of the laser cut areas corresponding to the size and shape of the drainage device. glaucoma cut into the first sacrificial layer.
The stencil and placed layers were placed on a heated press plate, such as a desktop hot press, preheated to approximately 280 ° C, and compressed sufficiently for a designated period of at least 5 minutes to produce a bond. between the first and second coupons of microporous diffusion material and the adhesive film, while avoiding significant bonding of the laminate to the sacrificial layers. The laminate was then removed from the press and allowed to cool to room temperature.
The resulting laminate was then laser cut to the final size consistent with the laser cutting process of Example 1, with the exception that no ridges were cut around the rectangular portion defining the erosion element. The resulting laminate included a lower microporous diffusion material layer consistent in size and shape with the shape of the second layer 9020 illustrated in Figure 10 and an upper microporous diffusion material layer consistent in size and shape with the shape of the first layer 9010. illustrated in Figure 10.
A fluid conduit consisting of a silicone tube was inserted between the uncompressed layers leading into the glaucoma drainage device, slightly separating the uncompressed layers and inserting the tube to a defined interior perimeter where the first and second coupons of microporous diffusion material. The tube was then secured to the glaucoma drainage device according to known methods.
Example 3
The ePTFE hydrophobic device assembly of Example 1 or 2 was hydrophilically coated in the following manner. The ePTFE was moistened by direct administration of approximately 1 ml of 100% isopropyl alcohol through the device's fluid conduit (eg, silicone tubes) and rinsed through the ePTFE reservoir. The excess alcohol was flushed out of the device with approximately 1 ml of deionized water (nominal resistance ~ 10<sup>Λ</sup>6 ohms) directed through the fluid path and the ePTFE reservoir. Approximately 1 ml of aqueous 0.2% by weight polyvinyl alcohol solution was rinsed directly through the fluid conduit and ePTFE reservoir, and allowed to equilibrate for approximately 10 minutes. Approximately 1 ml of distilled water was expelled through the fluid line and the ePTFE reservoir. Approximately 1 ml of aqueous crosslinking solution (2 volume% glutaraldehyde in approximately 0.3 Molar hydrochloric acid) was raised in temperature to approximately 40 ° C and rinsed directly through the device, and allowed to equilibrate for approximately 15 minutes. Approximately 2.5 ml of deionized water was rinsed directly through the fluid line and the ePTFE reservoir. The material was then equilibrated in a beaker of approximately 40 ml of fresh deionized water.
The resulting assembly was subsequently dried in an air oven at 115 ° C for approximately 10 minutes.
Example 4
A device of Example 3 was implanted in the superotemporal quadrant in the subconjunctival plane of a White New Zealand Rabbit and evaluated over a live period of 14 days. During implantation, the limbus was tunneled using a 25 gauge needle, in which the fluid passage was passed into the anterior chamber. To visualize the aqueous fluid reservoir, a 0.01% sodium fluorescein aqueous solution was used. Strong fluorescent and ultraviolet light excites the infused fluorescein, and it is easily visible in a dark environment. Prior to sacrifice, a 0.01% aqueous sodium fluorescein solution is injected into the anterior chamber of the implanted eye using a 30-gauge needle at a nominal flow rate of approximately 10 µΙ / min over a period of approximately 10 minutes. In the 14 day time interval, a strongly fluorescent deposit was observed, as well as fluorescent vessels emanating from the implant deposit area.
The inventive scope of this application has been described above, both generically and with respect to specific examples. It will be apparent to those skilled in the art that various modifications and variations can be made to the examples without departing from the scope of the description. Also, the various components mentioned in the examples mentioned herein can be combined. Therefore, the examples are intended to cover modifications and variations of the inventive scope.
Example 5
A thin coil was created by tightly wrapping an ePTFE suture around a 0.114 cm (0.045 ”) stainless steel wire. The suture coil was helically wrapped with approximately 2 layers of ePTFE (with an FEP coating on the ePTFE facing outward). The ePTFE was subsequently wrapped with another layer of ePTFE. The whole assembly was heated to 320 ° C for approximately 5 minutes. Once cooled, the 0.114 cm (0.045 ") stainless steel core wire was removed, leaving an ePTFE fluid conduit with a suture coil reinforcing member in the lumen of the fluid conduit.
To remove the suture coil reinforcing member from the fluid conduit lumen, the clinician grasps the end of the suture at the end of the fluid conduit and pulls, which causes the suture coil to unravel and emerge from the fluid conduit.
Example 6
A ~ 2.3 cm length of raw 6 mil nitinol wire ("first mandrel") was inserted through the end of the fluid conduit of Example 1, and advanced into the center of the reservoir of the device of Example 1. The The first mandrel (eg, first reinforcing member) is configured to add temporary rigidity to the device and facilitate device placement during the implantation procedure. The first mandrel can be removed once the device is implanted, but before the fluid conduit is inserted through the scleral tissue and into the anterior chamber.
A ~ 0.9 cm length of straight 7 mil nitinol wire ("short mandrel") was inserted through the end of the Example fluid conduit, advanced approximately 0.2 cm from the end of the fluid conduit, and subsequently advanced through from the fluid conduit wall. The short mandrel (eg, the second reinforcing member) is configured to remain engaged with the fluid conduit to assist the clinician in advancing the end of the fluid conduit through the scleral tissue and into the anterior chamber. The short mandrel can be removed once the end of the fluid conduit advances through the scleral tissue into the anterior chamber. The opening formed in the fluid conduit for the short mandrel is close enough to the end of the fluid conduit that it can fully reside in the anterior chamber to avoid a risk of aqueous humor leakage.
Contents5
14 sheets
Sheet 1 Sheet 2 Sheet 3 Sheet 4 Sheet 5 Sheet 6 Sheet 7 Sheet 8 Sheet 9 Sheet 10 Sheet 11 Sheet 12 Sheet 13 Sheet 14
72 members in 10 offices
Priority claims5
| Document | Office | Kind | Date |
|---|---|---|---|
| 62473090 | United States of America | – | |
| 201762473090 | United States of America | P | |
| 15922696 | United States of America | – | |
| 201815922696 | United States of America | A | |
| 2018022929 | United States of America | W |
Members72
| Document | Office | Kind | |
|---|---|---|---|
| CA3056639A1 | Canada | A1 | |
| CA3056642A1 | Canada | A1 | |
| CA3056643A1 | Canada | A1 | |
| CA3194418A1 | Canada | A1 | |
| US2018263817A1 | United States of America | A1 | |
| US2018263818A1 | United States of America | A1 | |
| US2018263819A1 | United States of America | A1 | |
| WO2018170429A1 | World Intellectual Property Organization (WIPO) | A1 | |
| WO2018170433A1 | World Intellectual Property Organization (WIPO) | A1 | |
| WO2018170434A1 | World Intellectual Property Organization (WIPO) | A1 | |
| AU2018234851A1 | Australia | A1 | |
| AU2018236437A1 | Australia | A1 | |
| AU2018236441A1 | Australia | A1 | |
| KR20190123348A | Republic of Korea | A | |
| KR20190123349A | Republic of Korea | A | |
| KR20190126893A | Republic of Korea | A | |
| MX2019010900A | Mexico | A | |
| MX2019010901A | Mexico | A | |
| CN110621269A | China | A | |
| CN110621270A | China | A | |
| CN110621271A | China | A | |
| EP3595598A1 | European Patent Office (EPO) | A1 | |
| EP3595599A1 | European Patent Office (EPO) | A1 | |
| EP3595600A1 | European Patent Office (EPO) | A1 | |
| MX2019010902AThis record | Mexico | A | |
| JP2020509888A | Japan | A | |
| JP2020509892A | Japan | A | |
| JP2020509893A | Japan | A | |
| AU2018234851B2 | Australia | B2 | |
| AU2021200179A1 | Australia | A1 | |
| AU2021203695A1 | Australia | A1 | |
| CN113616415A | China | A | |
| CA3056643C | Canada | C | |
| CN110621270B | China | B | |
| AU2021200179B2 | Australia | B2 | |
| JP7068332B2 | Japan | B2 | |
| CN114522019A | China | A | |
| US11351058B2 | United States of America | B2 | |
| CN110621271B | China | B | |
| JP7100656B2 | Japan | B2 | |
| US11406533B2 | United States of America | B2 | |
| JP7122318B2 | Japan | B2 | |
| CA3056642C | Canada | C | |
| CN110621269B | China | B | |
| US2022331162A1 | United States of America | A1 | |
| JP2022163140A | Japan | A | |
| US11523940B2 | United States of America | B2 | |
| US2023054622A1 | United States of America | A1 | |
| US2023117758A1 | United States of America | A1 | |
| CA3056639C | Canada | C | |
| AU2021203695B2 | Australia | B2 | |
| KR102584827B1 | Republic of Korea | B1 | |
| KR102585488B1 | Republic of Korea | B1 | |
| KR20230142654A | Republic of Korea | A | |
| AU2023237149A1 | Australia | A1 | |
| KR102591905B1 | Republic of Korea | B1 | |
| JP7458446B2 | Japan | B2 | |
| JP2024069527A | Japan | A | |
| CN113616415B | China | B | |
| CN114522019B | China | B | |
| US12150897B2 | United States of America | B2 | |
| EP3595599B1 | European Patent Office (EPO) | B1 | |
| US2025057697A1 | United States of America | A1 | |
| EP4516276A2 | European Patent Office (EPO) | A2 | |
| ES3015563T3 | Spain | T3 | |
| EP4516276A3 | European Patent Office (EPO) | A3 | |
| KR102854128B1 | Republic of Korea | B1 | |
| AU2023237149B2 | Australia | B2 | |
| JP7812395B2 | Japan | B2 | |
| EP3595598B1 | European Patent Office (EPO) | B1 | |
| ES3069954T3 | Spain | T3 | |
| EP3595600B1 | European Patent Office (EPO) | B1 |
Numbers
- Publication
- 2019010902
- Application
- 10902
Titles2
- Spanish
- AUXILIARES DE ADMINISTRACIÓN PARA DERIVACIONES DE GLAUCOMA
- English
- ADMINISTRATIVE ASSISTANTS FOR GLAUCOMA REFERRALS
Classification
- CPC, 18
- A61F9/00781
- A61F9/0017
- A61F2240/001
- A61F2210/0076
- A61F2250/0003
- A61F2230/0091
- A61F2250/0023
- A61F2250/0051
- A61F2250/0059
- A61L2430/16
- A61L31/048
- A61M27/002
- A61L31/146
- A61M2210/0612
- A61M2205/04
- A61M2205/3334
- A61M2205/3341
- A61M27/00
- IPC, 1
- A61F9 007