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    • 专利摘要:
    METHOD, SURGICAL KIT AND DEVICE TO TREAT GLAUCOMA. A surgical kit includes at least one instrument and at least one implant device. The instrument has a needle body used to form a surgical passage through ocular tissue. The device includes a flexible tube that defines a duct for removing aqueous humor with an outer surface having a maximum cross-sectional dimension that is less than the maximum cross-sectional dimension of the needle body. The device incorporates a sealing feature including at least one element that defines a maximum cross-sectional dimension that is greater than the maximum cross-sectional dimension of the needle body and that is operatively disposed within the surgical passage and forms a seal between the surrounding ocular tissue and the element (s) as well as securing the device within the surgical passage. The kit (and devices thereof) can be used as part of a surgical method to divert aqueous humor into a space formed in ocular tissue.
    公开号:BR112014016938B1
    申请号:R112014016938-1
    申请日:2013-01-10
    公开日:2020-11-24
    发明作者:Leonard Pinchuk
    申请人:Innfocus, Inc；
    IPC主号:
    专利说明:

    Background of the Invention Field of the Invention
    [001] The present invention relates to surgical treatment of glaucoma. More particularly, this invention relates to medical devices and materials for diverting aqueous humor out of the anterior chamber through a surgically implanted duct passage. State of the art
    [002] Glaucoma is a progressive eye disease that manifests itself by means of high intraocular pressure ("IOP"). High blood pressure develops in an eye because of weakened outflow of aqueous humor. In open-angle glaucoma, the weakened outflow is caused by abnormalities in the drainage system of the anterior chamber. In closed-angle glaucoma, weakened outflow is caused by weakened aqueous access to the drainage system. If the pressure inside the eye remains high enough for a long enough period of time, total loss of vision occurs. Thus, glaucoma is a major cause of preventable blindness.
    [003] As shown in figure 1, eye 10 is a hollow structure in which the anterior chamber 20 contains a clear fluid called aqueous humor. Aqueous humor is formed by the ciliary body 12 adjacent to the posterior chamber 9 of the eye. The fluid, which is produced at a reasonably constant rate, then passes around lens 14, through the opening of the pupil in iris 18 and into the anterior chamber 20. Since in the anterior chamber 20, the fluid flows out of eye 10 through two different pathways. In the uveoscleral pathway, fluid permeates between muscle fibers of the ciliary body 12. This pathway accounts for approximately ten percent of the aqueous outflow in humans. The primary pathway for outflow of aqueous humor in humans is through the canalicular pathway, which involves the trabecular network (not shown) and the Schlemm canal 24.
    [004] The trabecular network and the Schlemm canal 24 are located at the junction between iris 18 and sclera 26. This junction, which is typically referred to as the angle, is identified as 28. The trabecular network is a shaped structure wedge that develops around the circumference of the eye. It is composed of bundles of collagens arranged in a structure such as a three-dimensional sieve. The bundles are lined with a monolayer of cells called trabecular cells. The spaces between the collagen bundles are filled with an extracellular substance that is produced by the trabecular cells. These cells also produce enzymes that degrade extracellular material. The Schlemm canal 24 is located adjacent to the trabecular network. The outer wall of the trabecular meshwork coincides with the inner wall of the Schlemm canal 24. The Schlemm canal 24 is a structure such as a tube that extends around the circumference of the cornea. In adult humans, the Schlemm channel is believed to be divided by septa into a series of autonomous channels with inactive ends. The aqueous fluid travels through the spaces between the trabecular bundles of the trabecular network, through the inner wall of the Schlemm 24 channel to the channel, through a series of collection channels that drain the Schlemm 24 channel and into the episcleral venous system (not shown).
    [005] The resistant outer membrane known as the sclera 26 covers the entire eye 10 except that part covered by the cornea 34, which is the thin transparent membrane that covers the opening of the pupil and the iris 18. The cornea 34 merges into the sclera 26 at a junction referred to as the limbus 32. A part of the sclera 26 is covered by a thin tissue called the Tenon membrane 36 (also called the Tenon capsule), which surrounds the optic nerve eye bulb (not shown) to the ciliary region. Close to its front, the Tenon 36 membrane merges with the conjunctiva 30 where it is attached to the ciliary region of the eye as shown.
    [006] In a normal patient, aqueous humor production is equal to the outflow of aqueous humor and intraocular pressure remains reasonably constant (typically in the range 8 to 18 mmHg). With glaucoma, there is abnormal resistance to the outflow of aqueous humor, which manifests itself as an increased IOP. Toometry is the measurement of IOP. In primary open-angle glaucoma, which is the most common form of glaucoma, abnormal resistance is believed to be along the external aspect of the trabecular network and the inner wall of the Schlemm canal 24. Primary open-angle glaucoma accounts for approximately eighty-five percent of all glaucomas. Other forms of glaucoma (such as angle-closure glaucoma and secondary glaucomas) also involve decreased outflow of aqueous humor through the canalicular pathway, but the increased resistance comes from other causes such as mechanical obstruction, inflammatory fragments, cellular obstruction, etc.
    [007] With increased resistance, the watery humor builds up because it can't get out fast enough. As the aqueous humor builds up, the IOP inside the eye increases. The increased IOP compresses the axons in the optic nerve and can also compromise the vascular supply to the optic nerve. The optic nerve carries vision from the eye to the brain. Some eyes appear more susceptible to damage from excessive lOP than other eyes. While research is investigating ways to protect the nerve from high blood pressure, the therapeutic approach currently available for glaucoma is to reduce intraocular pressure.
    [008] Clinical treatment of glaucoma is typically performed in a gradual manner. Medication is often the first treatment option. Administered topically or orally, these medications work to reduce aqueous production or they act to increase outflow. If a medication fails, the patient is often given a second medication and then a third and fourth medication. It is not uncommon to have glaucoma patients on four separate medications. Currently available medications have many serious side effects including: congestive heart failure, respiratory distress, hypertension, depression, kidney stones, aplastic anemia, sexual dysfunction and death. Furthermore, condoms in various medications are known to cause damage to the corneal endothelial cells that can manifest as corneal clouding. In addition, condoms can also change the characteristics of the conjunctiva which can result in additional filtering problems. Compliance with medication is also a major problem, with estimates that more than half of glaucoma patients do not follow their correct dosing plans, which can result in progressive vision loss.
    [009] When medication fails to adequately reduce IOP, laser trabeculoplasty is often performed. In laser trabeculoplasty, thermal energy from a laser is applied to several non-contiguous points in the trabecular meshwork. Laser energy is believed to stimulate the metabolism of trabecular cells in some way, and change the cellular material in the trabecular network. In a large percentage of patients, outflow of aqueous humor is improved and lOP decreases. However, the effect often does not last long and a significant percentage of patients develop a high IOP over the years following treatment. Treatment by laser trabeculoplasty is typically not repeatable. In addition, laser trabeculoplasty is not an effective treatment for primary open-angle glaucoma in patients under the age of fifty, nor is it effective for angle-closure glaucoma and many secondary glaucomas.
    [0010] If laser trabeculoplasty does not reduce IOP sufficiently, then incisional surgery (typically referred to as filtering surgery) is performed. The most commonly performed incisional procedure is trabeculetomy. The trabeculetomy procedure involves cutting a "trapdoor" in the sclera and then, from inside the trapdoor wall, punching a hole in the anterior chamber that allows fluid to drain from the previous chamber into the trapdoor, out of the trapdoor "door" and then into a pustule (a formation such as a bubble) under the conjunctiva, thus decreasing IOP. Suture materials are placed under controlled tension to keep the trap door sufficiently closed to control IOP and avoid hypotonia (ie, low IOP). This procedure is relatively difficult to perform correctly and has a high level of long-term complications. Additional interventions often need to be performed to adjust the tension on the suture materials to control IOP additionally.
    [0011] When trabeculetomy does not successfully lower eye pressure, the next step, and usually the last, is a surgical procedure that implements a glaucoma drainage (GDI) implant that removes aqueous humor from the anterior chamber to control the IOP. A GDI like this, as shown in U.S. Patent 6,050,970 to Baerveldt, is a drain pipe that is attached at one end to a plastic plate. The drain tube is comprised of a silicone rubber shunt with an outside diameter between 1.0 and 3.0 Frenchs; preferably with an internal diameter of 0.3 mm and an external diameter of 0.6 mm (1.8 French). The Baerveldt tube is implanted when first making an incision in the conjunctiva 30, exposing the sclera 26 and the natural plane between the sclera and Tenon's conjunctiva / membrane is dissected downwards slightly beyond the equator. The plastic plate is then sewn to the sclera surface, usually over the equator. A full-thickness hole is made in the eye under limbus 32, usually with a needle. The tube is inserted into the eye through this needle tract. The outside of the tube is covered with cadaver sclera or another equivalent tissue to prevent it from eroding through the conjunctiva. Conjunctiva 30 is replaced and the incision is closed tightly. With this bypass device, aqueous drains out of the anterior chamber through the tube and along the surface of the plate and into the pustule, where the pustule is defined as a thin layer of connective tissue that encapsulates the plate and tube. The plate typically has a large surface area, which can be as large as 20 mm in diameter, in order to function as a wick and disperse fluid. Once fluid accumulates in the pustule, it can be absorbed through the tissues of the pustule and into the sclera venous system or to the surface of the eye where it can evaporate or be collected in the tear ducts. These plates are generally made of silicone rubber, which eventually becomes encapsulated by the connective tissue of the pustule. These large encapsulated plaques are irritating to some patients.
    [0012] Some of the currently approved GDIs include valves in the tube that enters the anterior chamber of the eye in order to control IOP and prevent hypotonia. In addition, many GDIs including the aforementioned Baerveldt valve have their tubes connected outside to prevent hypotonia in the acute phase before capsules form around the device. The bonding suture materials are then split with a laser or dissolve within a month.
    [0013] Current GDIs have an effective half-life of two to five years from implantation before a second, third or fourth GDI is required. Because of the massive size of current GDIs, there is room for only three devices in the eye; rarely is a fourth device implanted. The problems associated with GDIs of the current generation are: - Damage to eye movement and resulting double vision (diplopia). - Hypotonia (low IOP that can result in a separate retina). - Erosion of conjunctiva and infection and high costs associated with using a cadaver sclera to prevent erosion. In addition, cadaver sclerosis is difficult to obtain outside the United States and several religions do not allow the use of corpse tissue in the body. - Severe encapsulation of the plate that prevents proper fluid filtration and results in lower IOP control.
    [0014] The difficulty of performing trabeculetomias and GDIs as well as their associated morbidities led to the development of an unprecedented glaucoma drainage implant described in US patents 7,431,709, 7,594,899 and 7,837,644 by the same applicant of the present invention and incorporated in this document in its entirety by reference. Summary of the Invention
    [0015] In one embodiment, a kit is provided to treat glaucoma that includes at least one hand instrument and at least one aqueous humor drainage device. The hand instrument has a needle body that is inserted through ocular tissue into the anterior chamber of the eye to define a passage through the ocular tissue resulting in the anterior chamber. It is also considered that entry through the ocular tissue can be selectively enlarged by means of a piercing wound or by manipulating the tip of the needle body to better accommodate the aqueous humor drainage device. The needle body has a maximum cross-sectional dimension (for example, the diameter D1 in figure 5) along its length.
    [0016] The aqueous humor drainage device includes a flexible tube that defines a duct to remove aqueous humor from the anterior chamber. The tube has a proximal end and distal end opposite each other. The distal end may have a tapered profile that facilitates insertion into the passage resulting in the anterior chamber formed by the needle body. The outer surface of the tube has a maximum cross-sectional dimension (for example, the outer diameter D2 of figure 7) which is smaller than the maximum cross-sectional dimension of the needle body (for example, the diameter D1 of figure 5). The device also incorporates a sealing feature that includes at least one element that is spaced next to the proximal and distal ends of the tube and that extends radially outwardly beyond the outer surface of the tube. The element (s) define (s) a maximum cross-sectional dimension that is greater than the maximum cross-sectional dimension of the needle body (for example, the outer diameter D1 of figure 5). The element (s) is (are) operationally disposed (s) within the passage defined by the needle body, and its relative dimensions cause the surrounding eye tissue to directly contact the element (s) in order to form a seal between the surrounding tissue and the element (s). The seal surrounds the total circumferential circumference of the device defined by the element (s) and seal prevents leakage of aqueous humor through the space between the tube and the surrounding eye tissue. The sealing feature element (s) also acts to hold the device in place in the passageway and minimize migration of the device in both the proximal and distal directions. The maximum cross-sectional diameter of the sealing feature element (s) is defined by at least one abrupt surface to facilitate sealing.
    [0017] In one embodiment, the element (s) of the sealing feature is (are) realized by means of two flaps that are arranged opposite each other on opposite sides of the tube. The two flaps can be generally flat in shape and are in a common plane that extends across the central geometric axis of the tube. The generally coplanar configuration of the tabs minimizes the device profile in order to reduce erosion and migration of the device. The two tabs can be mirror images of each other reflected around the central geometric axis of the tube. The outer edges of the flaps may have a tapered profile facing the distal end of the tube. This tapered profile facilitates the introduction of the flaps into the passage formed by the needle body. The flaps can have a profile that tapers in the radial direction (that is, in the direction of the common plane of the two flaps) transverse to the central geometric axis of the tube.
    [0018] In one embodiment, the instruments in the kit (including at least one handheld instrument and at least one aqueous humor drainage device) are housed in one or more enclosures that provide the surgeon with easy access to the instruments as needed. The wrapper (s) can be made of suitable material (such as a thermoplastic) that is inexpensive and easily disposable to use once. Other materials (such as stainless steel and others) suitable for non-disposable applications can also be used.
    [0019] An insert can be used to position the device in the passage resulting in the anterior chamber formed by the needle body. The insert can be made by an apparatus similar to that described in U.S. patents 7,431,709, 7,594,899, and 7,837,644 with one or two slots that accommodate the flaps of the device. Alternatively, the insert can be made by a stylus and / or a trocar device as described below. In such embodiments, the insert may be part of the instrument kit housed in the housing.
    [0020] In another embodiment, one or more elements of the kit can be used as part of a surgical method to divert aqueous humor into a region of the bag formed in the ocular tissue (such as a bag formed between the conjunctiva-sclera and the membrane of Tenon). Brief Description of Drawings
    [0021] Figure 1 is an illustration showing anatomical details of the human eye.
    [0022] Figure 2 is a schematic view of a modality of a hand instrument to define a surgical passage through tissue leading into the anterior chamber of the eye.
    [0023] Figure 3 is a perspective view of an embodiment of an aqueous humor drainage device that drains aqueous humor from the anterior chamber of the eye.
    [0024] Figure 4 is a perspective view of an embodiment of a surgical kit wrapper.
    [0025] Figure 5 is a side view of an illustrative embodiment of a needle body that is part of the hand instrument of figure 2.
    [0026] Figure 6 is a top view of an illustrative embodiment of the aqueous humor drainage device of Figure 3.
    [0027] Figure 7 is a side view of an illustrative embodiment of the aqueous humor drainage device of Figure 3.
    [0028] Figures 8-11 are seen in perspective of different modalities of an aqueous humor drainage device.
    [0029] Figures 12A - 12D are schematic cross-sectional views of different modalities of an aqueous humor drainage device, showing the maximum cross-sectional profiles of the sealing flaps of the respective modalities.
    [0030] Figure 13A is a top view of an embodiment of an aqueous humor drainage device.
    [0031] Figure 13B is a schematic cross-sectional view of the aqueous humor drainage device of Figure 13A through the cross section identified by 13B-13B, showing a circular cross-sectional profile of the sealing tabs of the aqueous humor drainage device.
    [0032] Figure 14A is a top view of an embodiment of an aqueous humor drainage device.
    [0033] Figure 14B is a schematic cross-sectional view of the aqueous humor drainage device of Figure 14A through the cross section identified by 14B-14B, showing an oblong cross-sectional profile defined by the sealing tabs of the aqueous humor drainage device. .
    [0034] Figure 15 is an illustration showing the aqueous humor drainage device of Figure 3 implanted in the eye to derive aqueous humor from the anterior chamber to a space between Tenon's membrane and the sclera of the eye.
    [0035] Figure 16 is a schematic view illustrating an embodiment of a stylus and an aqueous humor drainage device, the stylus for use when positioning the aqueous humor drainage device.
    [0036] Figure 17 is a schematic view illustrating another embodiment of a stylus and an aqueous humor drainage device, the stylet for use when positioning the aqueous humor drainage device.
    [0037] Figure 18A is a schematic illustration of a modality of a knife used in a surgical method to treat high intraocular pressure, the knife to define a passage through tissue and in communication with the anterior chamber of the eye.
    [0038] Figure 18B is an enlarged view of the distal end of the knife in figure 18A.
    [0039] Figure 18C is a schematic illustration of a modality of a hand instrument used in a surgical method to treat high intraocular pressure, the instrument for defining a passage through tissue and in communication with the anterior chamber of the eye.
    [0040] Figure 19 is a side view of a modality of a trocar device used in a surgical method to treat high intraocular pressure, the trocar device inserted in a passage through tissue and in communication with the anterior chamber of the eye, and the trocar device receiving the tube of an aqueous humor drainage device for insertion of the tube of the aqueous humor drainage device in the passage.
    [0041] Figures 20A to 20E illustrate the function of the trocar device of figure 19 in an exemplary surgical method.
    [0042] Figure 21 is a side view of an alternative embodiment of a trocar device used in a surgical method to treat high intraocular pressure, the trocar device inserted in a passage through tissue and in communication with the anterior chamber of the eye, and the trocar device receiving the tube from an aqueous humor drainage device for insertion of the tube from the aqueous humor drainage device into the passageway.
    [0043] Figures 22A to 22D illustrate the function of the trooper device of figure 21 in an exemplary surgical method. Detailed Description of Preferred Modalities
    [0044] As used in this document, the term "distal" is generally defined as in the direction of the patient's eye, or away from a user of the system / device / device. Conversely, "proximal" generally means towards the patient's eye, or towards the user of the system / device / device.
    [0045] Now returning to figures 2 and 3, a modality of a kit for treating glaucoma is shown, which includes at least one hand instrument 101 (figure 2) and at least one aqueous humor drainage device 201 (figure 3 ). The instrument 101 has a needle body 103 which is inserted through ocular tissue into the anterior chamber 20 of the eye (figure 1) to define a passage through the tissue leading into the anterior chamber 20. The needle body 103 it has a maximum cross-sectional dimension (for example, the diameter D1 in figure 5) along its length. The proximal end of the needle body 103 is rigidly coupled to a hub 105. A handle 107 is rigidly coupled to the hub 105. The handle 107 is gripped by the surgeon's fingers for manipulation of the needle body 103 as desired. A needle cover 109 can extend over the needle body 103 for security. The needle body 103 may have a hollow hole (or possibly a solid hole). The hub 105 and the handle 107 can be realized by means of a syringe body that includes a plunger that fits with the inside of a tube as is well known. A solution can be placed into the tube and pumped through the hollow needle body 103 through manual manipulation of the plunger. Furthermore, the needle body can be bent to a more desirable way to precisely place the needle tract, especially when the patient's nose is in the path of the needle handle.
    [0046] The aqueous humor drain device 201 includes a flexible tube 203 that defines a duct 205 for removing aqueous humor from the anterior chamber 20. The tube 203 has a proximal end 207 and the distal end 209 opposite each other. The distal end 209 can have a tapered profile that facilitates insertion into the passage resulting in the anterior chamber 20 formed by the needle body 103. The outer surface 211 of the tube has a maximum cross-sectional dimension (for example, the outer diameter D2 of figure 7) which is less than the maximum cross-sectional dimension of the needle body 103 (for example, the diameter D1 of figure 5). Device 201 also includes the first and second tabs or ribs 213A, 213B which are spaced beside the proximal and distal ends 207, 209 of tube 203. Flaps 213A, 213B extend radially outwardly beyond the outer surface 211 of tube 203 opposite each other on opposite sides of tube 203. The first and second flaps 213A, 213B can be generally flat in shape and are in a common plane that extends transversely to the central geometric axis of tube 203 as shown more clearly in figure 3. The generally coplanar configuration of the flaps 213A, 213B, when placed flat against the sclera of the eye, minimizes the profile of the device in order to reduce erosion and migration. The first and second tabs 213A, 213B can be mirror images of each other reflected around the central geometric axis of the tube 203 as shown. Flap 213A defines an outer edge 215A, and flap 213B defines an outer edge 215B. The maximum distance between the outer edge 215A and the outer edge 215B defines a maximum cross-sectional dimension that is greater than the maximum cross-sectional dimension of the needle body 103 (for example, the outer diameter D1 of figure 5). The flaps 213A, 213B are operatively arranged within the passage defined by the needle body 103 and their dimensions cause the surrounding fabric to directly contact the flaps 213A, 213B in order to form a seal between the surrounding fabric and the flaps 213A, 213B. The seal surrounds the total circumferential perimeter of the device defined by the flaps 213A, 213B and prevents leakage of aqueous humor through the space between the tube 203 and the surrounding tissue. The needle-defined passage can also be enlarged in the scleral area with the use of a sharp knife and associated piercing incision. The enlarged part can be formed before or after formation of the needle-defined passage. Flaps 213A, 213B may deform in the passage as they are inserted into the passage in response to forces applied by the surrounding tissue, and / or the surrounding tissue may deform (when compressing / stretching / thinning) as the flaps 213A , 213B are inserted into the passage. Such deformation is controlled by the maximum cross-sectional dimension of the flaps 213A, 213B in relation to the cross-sectional dimension of the passage (as formed by the needle body 103 or perforating incision) as well as by the hardness of the flap material 213A, 213B. Flaps 213A, 213B also act to hold device 201 in place in the passageway and minimize migration of device 201 in both proximal and distal directions.
    [0047] The outer edges 215A, 215B of the flaps 213A, 213B may have a tapered profile facing the distal end 209 as shown more clearly in figure 3. This tapered profile facilitates the introduction of the flaps 213A, 213B into the passage formed by the body needle 103.
    [0048] The flaps 213A, 213B can have respective profiles that taper in the radial direction (that is, the direction of the common plane of the flaps) transverse and away from the central geometric axis of the tube 203 as shown more clearly in figure 3.
    [0049] The outer surface 211 of the tube 203 has a maximum cross-sectional dimension (for example, the outer diameter D2) which is less than the maximum cross-sectional dimension of the needle body 103. For example, the outer surface 211 may have a outer diameter D2 less than 0.4 mm (as in the order of 0.35 mm) for a needle body 103 with a maximum cross sectional dimension of 0.4 mm. In one embodiment, duct 205 of tube 203 is a lumen of simple constant diameter with a diameter in the range between 0.05 mm and 0.15 mm. This small diameter duct limits the flow of aqueous humor through the 203 tube and allows control over IOP without the need for one-way valves or other structures (such as filters) that limit the flow of aqueous humor through the tube. More specifically, the diameter of the duct 205 alone controls the rate of aqueous humor flow through the 205 tube and thus controls the patient's IOP. The appropriate duct diameter can vary between patients depending on the rate of aqueous humor production and the extent of clogging of the patient's natural drainage paths and thus can be selected by the physician as desired.
    [0050] In one embodiment, the instruments in a kit, including at least one handheld instrument 101 (figure 2) and at least one aqueous humor drainage device 201 (figure 3) as described in this document, are housed in a or more wrappers, such as an instrument tray 401 as shown in figure 4, which provides the surgeon with easy access to the instruments as needed. The 401 instrument tray can be made of suitable material (such as a thermoplastic) that is inexpensive and readily disposable to use once. Other materials (such as stainless steel and others) suitable for non-disposable applications can also be used. The kit may include a plurality of hand instruments 101 (figure 2) with needle bodies of different diameters and / or a plurality of aqueous humor drainage devices 201 (figure 3) with tube ducts and / or flaps of different sizes (for example, a plurality of devices 201 with different flap sizes that correspond to needle body diameters ranging from instruments 101 in the kit). Furthermore, to make the piercing incision, knives of different diameters (discussed below with respect to figures 18A and 18B) can be included in the kit as well as measuring devices, medications, sponges for applying medication, measuring devices, markers, syringes, rinsing fluid, trocars, inserters and more.
    [0051] An insert can be used to position the device 201 in the passage resulting in the anterior chamber 20 formed by the needle body 103. The insert can be realized by means of an apparatus similar to that described in US patents 7,431,709, 7,594,899 , and 7,837,644 with one or two slots accommodating the flaps 213A, 213B of the device 201. Alternatively, the insert can be realized by means of a stylus and / or a changing device as described below. In such embodiments, the insert may be part of the instrument kit housed in tray 401.
    [0052] Figure 5 shows the dimensions of an exemplary embodiment of the needle body 103. In this exemplary embodiment, the needle body 103 has an outer diameter D1 of 0.4 mm (i.e., caliber 27). Other suitable D1 outside diameters can be in the range of 0.4 mm (i.e., caliber 27) to 0.635 mm (i.e., caliber 23). The needle body 103 can also be provided curved to a desirable shape to allow the needle to be inserted into the eye at an angle that if not curved would interfere with the patient's nose.
    [0053] Figures 6 and 7 show the dimensions of an exemplary embodiment of an aqueous humor drainage device 201 for use with the needle body 103 of figure 5. Tube 203 is 8.5 mm long. Duct 205 has a diameter of 0.07 mm. The outer surface 211 has a maximum cross-sectional diameter (diameter D2) of 0.35 mm, which is smaller than the outer diameter D1 of the needle body 103. The flaps 213A, 213B are spaced 4.5 mm from the distal end 209 of tube 203 and spaced 3 mm from proximal end 207 of tube 203. Flaps 213A, 213B are generally flat in shape and are in a common plane that extends across the central geometric axis of the tube 203. Flaps 213A, 213B are mirror images of each other reflected around the central geometric axis of tube 203 as shown. The flat shape of the first and second flaps 213A, 213B has a maximum thickness in the order of 0.35 mm (that is, the outer diameter D2 of the pipe 203), a dimension in the length of 1 mm parallel to the central geometric axis of the tube 203, and a maximum cross-sectional dimension between the edges 215A, 215B of 1.1 mm. In other designs, the maximum cross sectional dimension between edges 215A, 215B can be in the range between 0.9 mm and 1.5 mm. Such a maximum cross-sectional dimension is significantly larger than the 0.4 mm outer diameter D1 for the needle body 103 of Figure 5.
    [0054] Figures 8 to 14B illustrate alternative designs for the flaps of the implantable aqueous humor drainage device. In the design of figure 8, the flaps 213A1, 213B1 have a profile that tapers in the radial direction transverse to the central geometric axis of the tube 203 where the tapered radial surfaces of the flaps extend from a flat feature 217. In the design of figure 9, the flaps 213A2, 213B2 are parts of a wedge-shaped triangular body 219 arranged along the length extension of the pipe 203. The proximal walls 221A, 221B of the wedge-shaped body 219 are oriented transversely to the central geometric axis of the pipe 203, which is intended to help reduce migration of tube 203 in the proximal direction out of the passage formed by instrument 101. In the design of figure 10, flaps 213A3, 213B3 have proximal walls 223A, 223B that are oriented transversely to the central geometric axis of tube 203, which is intended to help reduce migration of tube 203 in the proximal direction out of the passage formed by instrument 101. In the design of figure 11, each of the flaps 213A4, 213B4 has a curved wedge-shaped shape. In the design of figure 12A, the flaps 213A5, 213B5 and the tube 203 define a cross sectional diamond profile with rounded corners (in particular, the diamond profile tapers in the transverse radial direction and away from the central geometric axis of the tube 203). The tapered surfaces of the flaps 213A5, 213B5 extend from the annular surface of the tube 203 as shown. In the design of figure 12B, the flaps 213A6, 213B6 define a cross sectional profile of an oblong with semicircular ends as shown. Alternatively, the flaps 213A6, 213B6 can define a cross sectional profile of an oblong with semi-elliptical ends. In the design of figure 12C, the flaps 213A7, 213B7 define a cross sectional profile of an ellipse whose contour is displaced radially from the annular surface of the tube 203 and surrounds it. In the design of figure 12D, the flaps 213A8, 213B8 define a cross-sectional profile of an ellipse of greater radius (when compared to the elliptical profile of figure 12C) whose contour is displaced radially from the annular surface of the tube 203 and surrounds it.
    [0055] In the design of figures 13A and 13B, a flap such as stopper 213 'is provided that extends circumferentially beyond the annular surface of tube 203. The flap such as stopper 213' has a cross sectional profile of such a circle as is evident in the view of figure 13B.
    [0056] In the design of figures 14A and 14B, a generally flat flange 213 "is provided that extends circumferentially beyond the annular surface of tube 203. The generally flat flange 213" has an oblong cross sectional profile as is evident in the view of figure 14B.
    [0057] The outer surface (s) of the flap (s) of the device 201 can be abrupt (s) with rounded lines as shown, and thus avoid any sharp corners and edges . The abrupt outer surface (s) of the flap (s) is (are) particularly suitable for forming a seal for the surrounding tissue as described in this document.
    [0058] In the design of figure 11, a slit 225 is formed in the flaps 213A, 213B in such a way that the slit 225 passes through the lumen 205 of the aqueous humor drain device 205. Slit 225 is positioned proximal to that part of the flaps 213A, 213B forming the seal for the surrounding fabric (i.e., the abrupt outer edges of the flaps 213A, 213B at their maximum radial distance from the central geometric axis of the tube 203). The purpose of the 225 slot is twofold. First, slit 225 can act as a pressure relief valve in the event that the lumen 205 of the aqueous humor drainage device 205 becomes clogged downstream because of overgrowth of tissue in the pustule. The elastomeric nature of the aqueous humor drain device 205 is such that, as pressure increases within the lumen 205, the slit 225 may deform to an open state where aqueous humor is released into the pustule thereby reducing pressure on the anterior chamber. The second advantage of slot 225 is to deliberately accomplish the same purpose, that is, to relieve pressure in the anterior chamber. In order to effect this release, lumen 205 downstream of slit 225 is tightly sealed thus forcing fluid to escape through slit 225. Slit 225 length and width controls the pressure at which aqueous humor escapes and can be adapted to prevent hypotonia . The aqueous humor escapes through the slit 225 and flows proximally in the space between the surrounding tissue and the external surface of the proximal part of the tube 203. Fluid that escapes through the slit 225 will have its pressure reduced both by the narrow lumen 205 of the distal part of the tube 203 and by the slot 225. Perianular leak of aqueous humor in the space between the surrounding tissue and the outer surface of the distal part of the tube 203 is prevented by the seal formed by the flaps 213A, 213B. More specifically, the abrupt outer edges of the flaps 213A, 213B in their maximum radial displacement with respect to the central geometric axis of the tube 203 form a seal with the surrounding tissue that prevents such perianular leakage of aqueous humor.
    [0059] The aqueous humor drainage device 201 may be formed of a homogeneous polymeric material. In one embodiment, the homogeneous polymeric material is a polyolefinic copolymer material having a triblock polymer backbone comprising polystyrene-polyisobutylene-polystyrene, which is referred to in this document as "SIBS". SIBS can also be referred to as polyl (styrene-b-isobutylene-b-styrene) where b represents "block". High molecular weight (GDP) polyisobutylene is a soft elastomeric material with a Shore hardness of approximately 10A to 30A. When copolymerized with polystyrene, it can be made with hardnesses varying up to the polystyrene hardness, which has a Shore hardness of 100D. Thus, depending on the relative amounts of styrene and isobutylene, the SIBS material can have a range of hardnesses from as soft as Shore 10A to as hard as Shore 100D. In this way, the SIBS material can be adapted to have the desired elastomeric and hardness qualities. In the preferred embodiment, the SIBS material of the aqueous humor drainage device tube 201 has a hardness less than Shore 50A and greater than Shore 20A. Details of the SIBS material are set out in U.S. Patent Nos. 5,741,331, 6,102,939, 6,197,240 and 6,545,097, which are incorporated into this document by reference in their entirety. The SIBS material of the aqueous humor drainage device 201 can be polymerized according to a control device using carbocationic polymerization techniques such as those described in U.S. Patent Nos. 4,276,394, 4,316,973, 4,342,849, 4,910,321, 4,929,683, 4,946,899, 5,066,730, 5,122,572 and Re 34,640, each of which is incorporated herein in its entirety by reference. The amount of styrene in the copolymer material is preferably between 16 mol% and 30 mol% and more preferably between 20 mol% and 27 mol%. The styrene and isobutylene copolymer materials are preferably glass limerized in solvents.
    [0060] Vitreous segments alternative to the aforementioned styrene can be used to make the aqueous humor drainage device 201. The vitreous segment provides a more rigid component for elastomeric polyisobutylene. The vitreous segment preferably does not contain any divisible groups that will release in the presence of body fluid within the human eye and will cause toxic side effects and cell encapsulation. The vitreous segment may be an aromatic vinyl polymer (such as styrene, alpha-methyl styrene or a mixture thereof), or a methacrylate polymer (such as methyl methacrylate, ethyl methacrylate, hydroxymethacrylate or a mixture thereof). Such materials preferably have a general block structure with a central elastomeric polyolefin block and thermoplastic end blocks. Such materials have a general structure:
    [0061] BAB or ABA (linear triblock),
    [0062] B (AB) n or a (BA) n (linear alternating block), or
    [0063] X- (AB) n or X- (BA) n (includes diblock, triblock and other radial block copolymers), where A is an elastomeric polyolefinic block, B is a thermoplastic block, n is a number positive integer and X is a seed seed molecule.
    [0064] Such materials can be block copolymers in the form of a star (where n = 3 or more) or block copolymers in the form of multiple dendrites. In addition to the glass segments, crosslinkers can be incorporated into the polymer to provide a thermal set version of SIBS. Exemplary polymers incorporating these crosslinkers are described in detail in U.S. Patent Publication 20090124773, incorporated herein in its entirety by reference. These materials collectively belong to the polymeric material referred to in this document as SIBS material.
    [0065] Other polymeric materials can be used to provide the aqueous humor drainage device 201 according to this invention. Exemplary materials are flexible materials that can mold to the surface of the eye and include, but are not limited to, silicone rubber, polyolefins (butyl rubber, polybutadiene, styrene-ethylene-propylene-butadiene, polyethylene, polypropylene, etc.), polyurethane (polyether urethanes, polycarbonate urethanes, polyurethanes containing polyisobutylene or other soft polyolefin segments, etc.), acrylics (polyacrylates, poly (2-hydroxyethylmethacrylate), etc.), fluorine-containing polymers (PTFE, ePTFE, fluorosilicones, poly (- CH2-CF2) -, etc.), polyamides, hydrogels, bio-based structures such as those comprised of collagen, elastin, etc., and mixtures of all the materials indicated above as well as soft foams and Porous polymer materials can be used to make the aqueous humor drainage device 201. The polymeric material must be biocompatible and bio-stable within the ocular environment.
    [0066] The total aqueous humor drainage device 201 can be formed as a unitary part when molding the polymeric material. It is also considered that the polymeric material of the flaps 213A, 213B may be different from the polymeric material of the tube 203. This can be accomplished by means of insertion molding techniques or by other suitable thermoplastic forming techniques. The hardness of flaps 213A, 213B can be the same as that of tube 203, or they may differ from tube 203. In one embodiment, the hardness of flaps 213A, 213B are within the range between Shore 30A and Shore 80A.
    [0067] Now returning to figure 15, there is shown the aqueous humor drainage device 201 implanted in such a way that its distal end 209 is positioned inside the anterior chamber 20 of the eye and its proximal end 207 is positioned in a bag 300 formed between the Tenon membrane 36 and the sclera 26 (figure 1). Bag 300 defines a closed space between Tenon membrane 36 and sclera 26 (figure 1). The duct 205 of the aqueous humor drainage device 201 transfers aqueous humor from the anterior chamber 20 to the pocket 300, which forms a shallow pustule. Watery humor is absorbed by the surrounding tissue and ends up in the venous system in the eye or in the tear film or simply evaporates outside the conjunctiva once it reaches it.
    [0068] The pouch 300 may extend backwards from a location in or near the limbus to the posterior part of the globe near or beyond the equator of the eye. The pocket 300 can be defined by making an incision through the conjunctiva or membrane of Tenon 36 to the scleral surface and then cutting and separating the Tenon membrane 36 from the sclera 26 (figure 1) over the area of the pocket 300. If the pouch joint is in the fornix of the eye, this type of pouch is known as a fornix-based pouch. If the joint is in the limbus and the incision in the fornix, this type of bag is known as a limbo-based bag. The distal end 209 of the aqueous humor drainage device 201 is inserted through a needle-shaped passage through the angle 28 into the anterior chamber 20 of the eye. The device 201 is further advanced in the passage in such a way that the flaps 213A, 213B (only the flap 213A is shown in figure 15) are positioned inside the passage. The dimensions of the flaps 213A, 213B cause the surrounding fabric to directly contact the flaps 213A, 213B in order to form a seal between the surrounding fabric and the flaps 213A, 213B. The seal surrounds the total circumferential perimeter of the device defined by flaps 2213A, 213B and prevents leakage of aqueous humor through the space between the tube 203 and the surrounding tissue. Flaps 213A, 213B may be deformed in the passage as they are inserted into the passage in response to forces applied by the surrounding tissue, and / or the surrounding tissue may be deformed (by stretching / thinning) as the flaps 213A, 213B are inserted into the passage. Such deformation is controlled by the maximum cross-sectional dimension of the flaps 213A, 213B in relation to the cross-sectional dimension of the passage (as formed by the needle body 103) as well as by the hardness of the flap material 213A, 213B. Flaps 213A, 213B also act to hold tube 203 in place in the passage and minimize migration of tube 203 in both the proximal and distal directions. After proper positioning of device 201, pocket 300 is closed. A sponge, absorbent paper or other suitable carrier loaded with an antiproliferative agent can be placed inside the pouch 300 before it is closed. The antiproliferative agent can be, for example, mitomycin C or 5-Fuorouracil or other antimetabolites or other suitable drug (s) or compound (s) that are released immediately or over time and work (m) to minimize fibrosis of the conjunctiva-sclera to the Tenon membrane, thus maintaining the structure of the pocket 300 for an extended period of time. Alternatively, a collagen sponge or other space filling structure or fluid can be placed in the bag to prevent scarring of the Tenon's conjunctiva / membrane to the sclera. Aqueous humor flows from the anterior chamber 20 through the tube 205 of the device 203 and into the sealed bag 300. The sealed bag 300 prevents bacteria from entering the device 201 and infecting the eye. Watery humor exiting device 201 and entering sealed pouch 300 creates a very shallow pustule. The pustule fluid can filter through the conjunctiva 30 (figure 1) for tears or evaporate from it, and the fluid can be absorbed by the lymphatic system and capillaries that penetrate the conjunctiva 30 (figure 1). A fraction of the aqueous humor contained in the pustule can potentially leak through the permeable sclera 26 and be absorbed by the choroidal capillaries.
    [0069] The aqueous humor drainage device 201 can be implanted in the position shown in figure 15 using the following method. Bag 300 is made by cutting conjunctiva 30 in limbus 32 in an incision area that is smaller than a quadrant using miniature scissors (Vannas scissors or similar) and cutting and separating Tenon 36 membrane from sclera 26 in a few millimeters ( a tab based on the fornix). Then, retaining the edge of the pouch 300 in its center with toothed forceps, the closed ends of blunt scissors (for example, Westcott or similar) are pushed slowly down towards the eye equator and opened until the membrane is separated (delaminar) Tenon 36 from sclera 26. The scissors are closed again; their tips pushed further forward and reopened to separate a larger area of the Tenon 36 membrane. The process is repeated until the scissor tips are 17 to 20 mm away from the limbus 32. The bag 300 thus created is larger at the equatorial base of the than at the limbal entrance.
    [0070] The pocket 300 is formed adjacent to the limbus 32. A mark, centered in the middle part of the conjunctival opening, is made 2-3 mm behind the edge of the limbus using a blunt calibrator. A fabric dye can be used on the tip of the calibrator to increase contrast of the fabric mark. A hand instrument 101 with a needle body 103 (figure 1) is prepared and the tip of the needle body 103 is positioned on the mark made on the sclera. A surgical passage is modeled to connect the external scleral wall to the anterior chamber by pushing the needle body 103 in a plane such that the tip of the needle body 103 enters the eye through the angle 28 into the anterior chamber 20. In this way, the surgical passage passes through the conjunctiva-sclera in the vicinity of the 28 angle and into the anterior chamber 20. Instrument 101 can be a syringe that holds a pharmacological solution, such as epinephrine or lipo-caine. The surgeon may choose to dispense the syringe solution into the anterior chamber 20 after inserting the distal end of the syringe needle body 103 into the anterior chamber 20. After waiting for some time (for example, a few seconds), the needle body 103 is slowly retracted. The aqueous humor drainage device 201 is inserted into the surgical passage to the position shown in figure 15 whereby the distal end 209 exits into the anterior chamber 20 of the eye and the flaps 213A, 213B are positioned within the surgical passage. Before introducing device 201 into the surgical passage, the proximal end of the surgical passage can be enlarged on the scleral surface by means of a perforating incision with a sharp knife (such as the knife in figures 18A and 18B as described below) or by cut the entrance to the sclera with the sharp edge of the needle body 103 as it is removed. This perforating incision can assist in introducing the flaps 213A, 213B of device 201 into the surgical passage. Alternatively, before making the surgical passage, the sharp knife is used to make a shallow slit or perforating incision in the sclera. A needle is then inserted into the slot and the surgical passage is formed under the limbus. The flaps 213A, 213B are then threaded through the perforating incision as previously described. The dimensions of the flaps 213A, 213B cause the eye tissue surrounding the surgical passage to directly contact the flaps 213A, 213B in order to form a seal between the surrounding eye tissue and the flaps 213A, 213B. The seal surrounds the total circumferential perimeter of the device defined by the flaps 213A, 213B and prevents leakage of aqueous humor through the space between the tube 203 and the ocular tissue surrounding the surgical passage. The proximal end 207 of the tube 203 is positioned inside the pocket 300 as shown in figure 15. The aqueous humor drain device 201 can be positioned by an insertion device similar to that described in US patents 7,431,709, 7,594,899 and 7,837,644 with one or two slots that accommodate flaps 213A, 213B of device 201. Alternatively, the aqueous humor drain device 201 can be inserted into the passageway using a stylus 301 and / or a trocar device 350 (or 410) as described below. Bag 300 is then closed with suture materials 304. Instead of suture materials, coagulation by bipolar diathermy, laser welding or adhesives such as cyanoacrylate, fibrin glue, etc. can be used to close bag 300. In addition, a trocar can be used to facilitate placement of the aqueous humor drainage device through the needle passage.
    [0071] To minimize inflammation as well as reduce surgical time, bag 300 can also be created by dissecting the conjunctiva in the limbus and, starting at one edge of the dissection, cutting the conjunctival tissue later by about 3 mm, thus creating a flap door. After forming the surgical passage through the exposed sclera and into the anterior chamber, the device 201 is positioned in the surgical passage with the proximal end of the device inside the bag 300 as shown in figure 15. The released edge of the conjunctiva 30 is then juxtaposed by surrounding 2 mm beyond its original position and retained stretched with a single suture, or a single laser weld, or a bipolar diathermy coagulation of a single point, or with a single point of adhesive. The edge of the conjunctiva 30 along the limbus 32 is never treated, but left intact to prevent necrosis of tissue that produces fibrosis. The corneal limb epithelial cells will quickly cover the wound edge (1 hour or less), sealing the conjunctival limbus.
    [0072] A sponge, absorbent paper or other suitable carrier loaded with one or more therapeutic agents can be placed inside the pouch 300 before it is closed. Such therapeutic agent (s) is released over time and minimizes fibrosis of the Tenon's membrane to the sclera, thus preventing further lamination and closure of the pustule space (the internal space of the closed pouch 300 surrounding proximal end 207 of tube 203). Therapeutic agents can include cytostatic agents (i.e., antiproliferation agents that prevent or delay cell division, for example, by inhibiting DNA reproduction, and / or by inhibiting spindle fiber formation, and / or by inhibiting cell migration) or other agents that minimize fibrosis or blood clots. Examples of such therapeutic agents are described below.
    [0073] Figure 16 shows the aqueous humor drainage device 201 with a stylus 301 which is removably inserted into the lumen 205 of the proximal part 209 of the device 201 to assist in the insertion of the device 201 into the needle-formed passage. The proximal end of stylet 301 is folded into a pigtail configuration 302 to enable the surgeon to pick up stylet 301 and remove it from the lumen 205 of the aqueous humor drain device 201 once it is in place. Figure 17 shows another embodiment of stylet 301 where a larger tube 303 is kneaded over the proximal end of the stylet to facilitate grasping and removal.
    [0074] Figures 18A and 18B show a hand knife 340 that can be used to make the perforating incision in the sclera to further secure the elements of the aqueous humor drainage device 201 to the sclera. The diameter "a" of the knife edge 341 is less than the maximum cross sectional diameter of the flaps 213A, 213B of the device 201 in order to enable a tight fit of the flaps 213A, 213B in the perforating incision. The length b of the edge knife 341 can be approximately equal to dimension a.
    [0075] Figure 18C shows an embodiment of a hand instrument 342 that includes a distal needle body 343 extending from a flat blade portion with the cutting surfaces 344A, 344B. The needle body 343 creates the passage leading through the sclera and the cutting surfaces 344A, 344B create an enlarged piercing incision in the sclera in one movement of the surgeon's hand.
    [0076] When the needle body is removed from the needle-formed passage, the needle passage from time to time may become oval (or collagen fibers may cross the passage or there is a fold in the passage), resulting in difficulty to place the aqueous humor drain device 201 through the passage. In order to facilitate placement of the aqueous humor drainage device 201 in the needle-formed passage through the sclera, a trocar 350 that includes a conduit 352 with an open slot 351 (figure 19) can be provided. The conduit 352 is dimensioned to receive the needle body 103 as well as the tube 203 of the aqueous humor drain device 201. The trocar 350 is placed over the needle body 103 to provide the assembly 360 shown in figure 20A. Figures 20B to 20E illustrate the function of trocar 350. Assembly 360 is inserted into the needle-shaped passage through sclera 400 as shown in figure 20B. The needle body 103 is then removed from the assembly leaving the trocar 350 in place as shown in figure 20C. The aqueous humor drain device 201 is then introduced through trocar 350 as shown in figure 20D. Trocar 350 is then removed leaving the aqueous humor drain device 201 inside the needle-shaped passage as shown in figure 20E. The elastic nature of tube 203 of device 201 allows tube 203 to bend and deform in such a way that it passes through slot 351 of trocar 350 as trocar 305 is removed. The position of the aqueous humor drainage device 201 within the passage can then be adjusted by the surgeon (for example, when additionally inserting the device 201 into the passage) in such a way that the flaps 213A, 213B connect via the wall interface of the passage and provide a seal between the fabric and the device 201. In this position, the flaps 213A, 213B also act to secure the device in the passage.
    [0077] Figure 21 shows another embodiment of a trocar 410, which includes a conduit 412 with a groove 411 that is partially opened along conduit 412. A section of the open groove cover (for example, tongue 413) remains integral with the tube as shown. The conduit 412 is sized to receive the needle body 103 as well as the tube 203 of the aqueous humor drainage device 201. The trocar 410 is placed over the needle body 103 with the hub 415 adjoining the proximal end of the conduit 412 for provide the assembly shown in figure 22A. Figures 22B to 22D illustrate the function of trocar 410. The assembly is inserted into the needle-shaped passage through the sclera 400 as shown in figure 22B. The contact of the conduit 412 with the hub 415 prevents the trocar 410 from sliding backwards over the needle body as it is inserted through tissue. The needle body 103 is removed from the trocar 410 as shown in figure 22C, which is facilitated by grasping the tongue 413 with forceps as the needle 103 is pulled out of the trocar 410. Once the needle body 102 is removed, trocar 410 is cut on line 420 (for example, with scissors) and the proximal portion of conduit 412 with tongue 413 is discarded as shown in figure 22D. The aqueous humor drainage device 201 is then introduced into the remaining trocar part 421 in the needle-formed passage in a manner similar to the method described above in combination with figure 20D. The trocar part 421 is then removed leaving the aqueous humor drainage device 201 inside the needle-shaped passage as shown in figure 20E. The elastic nature of tube 203 of device 201 allows tube 203 to bend and deform in such a way that it passes through slot 411 of trocar part 421 as the trocar part 421 is removed. The position of the aqueous humor drainage device 201 within the passage can then be adjusted by the surgeon (for example, when additionally inserting the device 201 into the passage) in such a way that the flaps 213A, 213B connect via interface to the wall. - fabric net of the passage and provide a seal between the fabric and the device 201. In this position, the flaps 213A, 213B also act to secure the device in the passage.
    [0078] Another embodiment considered by this invention is to first form the needle tract under the limbus with the needle 103, then preload the 203 tube of the aqueous humor drain device 201 in the trocar 350 or 410 and then push the assembly through the needle tract. The trocar is then removed from the needle tract as explained above.
    [0079] The trocars of figures 19 and 21 can be made of a fine rigid material, preferably polyimide. Other materials that can work in this capacity are PEEK, PEEKEK, polyurethane, polypropylene, high molecular weight polyethylene, nylon, fluorine-containing polymers, etc. Alternatively, the material forming the trocars can be made of metal (preferably well-known metals used in medical devices such as stainless steel, titanium, Nitinol, etc.). The main requirement is that when the trocar is inserted through tissue it cannot bend. The thickness of the trocar wall must be between 0.005 mm (0.0002 ") and 0.076 mm (0.003"); preferably between 0.025 mm (0.001 ") and 0.076 mm (0.003"). The internal diameter of the trocar should be equal to or greater than the diameter of the needle body 103, that is, if inserted over a needle, or equal to or greater than the flexible tube 102 if the trocar is preloaded with the drainage device. watery humor.
    [0080] The polymeric aqueous humor drainage device 201 (or parts of it) can be loaded with one or more therapeutic agents that release over time and minimize fibrosis from the Tenon membrane to the sclera, thus preventing further laxation. demining and closing the pustule space. Therapeutic agents loaded on device 100 may include cytostatic agents (i.e., antiproliferation agents that prevent or delay cell division, for example, by inhibiting DNA reproduction, and / or by inhibiting spindle fiber formation, and / or by inhibiting cell migration) or other agents that minimize fibrosis or blood clots. Examples of such therapeutic agents are as follows.
    [0081] Representative examples of therapeutic agents include the following: Visudyne, Lucentis (rhuFab V2 AMD), Combretastatin A4 Prodrug, SnET2, H8, VEGF Trap, Candõ, LS 11 (Taporfin Sodium), AdPEDF, RetinoStat, Integrin, Panzem, Retaane , Anecortave Acetate, VEGFR-1 mRNA, ARGENT cell signaling technology, Angiotensin II Inhibitor, Accutane for Blindness, Macugen (PE-Gylated aptamer), PTAMD, Optrin, AK-1003, NX 1838, Avb3 and 5 antagonists, Neovastat , Eos 200-F and any other VEGF inhibitor.
    [0082] Other therapeutic agents can be used such as: mitomycin C, 5-fluorouracil, corticosteroids (triamcino-canvas acetonide corticosteroid is the most common), modified toxins, methotrexate, adriamycin, radionuclides (for example, as disclosed in the US Patent No. 4,897,255, hereby incorporated by reference in its entirety), protein kinase inhibitors (including staurosporine, which is a protein kinase C inhibitor, as well as dihydroalkaloids and stimulators of TGF production or activation -beta, including tamoxifen and derivatives of functional equivalents, for example, plasmin, heparin, compounds capable of reducing the level or inactivating the Lp lipoprotein (a) or the glycoprotein apolipoprotein (a) thereof, nitric oxide releasing compounds ( eg nitro-glycerin) or analogues or functional equivalents thereof, paclitaxel or analogues or functional equivalents thereof (eg, taxotere or a Taxol®-based agent, c an active ingredient is paclitaxel), specific enzyme inhibitors (such as the nuclear enzyme DNA topoisomerase II and DAN polymerase, RNA polymerase, adenyl guanyl cyclase), superoxide dismutase inhibitors, terminal deoxynucleotidyl transferase, reverse transcriptase, antisense oligonucleotides which suppress cell proliferation, angiogenic inhibitors (for example, endostatin, angiostatin and squalamine), rapamycin, everolimus, zotarolimus, cerivastatin, and flavopyridol and suramine and more.
    [0083] Other examples of therapeutic agents include the following: peptide or mimetic inhibitors, such as antagonists, agonists, or competitive or non-competitive inhibitors of cellular factors that can activate cell proliferation or pericytes (for example, cytokines (eg , interleukins such as IL-1)), growth factors (e.g., PDGF, TGF-alpha or beta, tumor necrosis factor, smooth muscle and endothelial growth factors such as endothelin or FGF), addressing receptors (for example, for platelets or leukocytes), and extracellular matrix receptors (for example, integrins).
    Representative examples of therapeutic agents useful in the category of agents that address cell proliferation include: heparin subfragments, triazolopyrimidine (e.g., trapidil, which is a PDGF antagonist), lovastatin, and E1 or I2 prostaglandins.
    [0085] Some of the above and numerous additional therapeutic agents suitable for the practice of the present invention are disclosed in U.S. Patent Nos. 5,733,925 and 6,545,097, which are incorporated into this document by reference in their entirety.
    [0086] If desired, a therapeutic agent of interest can be provided at the same time as the polymer of which the device 201 is made, for example, by adding it to a molten polymer during thermoplastic processing or by adding it to a solution of polymer during solvent-based processing. Alternatively, a therapeutic agent can be provided after forming the device or part of the device. As an example of these embodiments, the therapeutic agent can be dissolved in a solvent that is compatible with both the device polymer and the therapeutic agent. Preferably, the device polymer is at most only slightly soluble in this solvent. Subsequently, the solution is brought into contact with the device or part of the device in such a way that the therapeutic agent is loaded (for example, by leaching / diffusion) into the copolymer. For this purpose, the device or part of the device can be immersed or bathed in the solution, the solution can be applied to the device or component, for example, by spraying, coating by printing immersion, immersion in a fluidized bed and so on. onwards. The device or component can subsequently be dried, with the therapeutic agent remaining therein.
    [0087] In another alternative, the therapeutic agent can be supplied within a matrix comprising the polymer of device 201. The therapeutic agent can also be covalently bonded, hydrogen bonded, or electrostatically bonded to the 201 device polymer. specific examples, nitric oxide-releasing functional groups such as S-nitroso-thiols can be provided in connection with the polymer, or the polymer can be provided with charged functional groups to fix therapeutic groups with oppositely charged functionalities.
    [0088] Also in another alternative embodiment, the therapeutic agent can be precipitated on one or more surfaces of the device 201 (or part of the device). These one or more surfaces can be subsequently covered with a polymer coating (with or without additional therapeutic agent) as described above.
    [0089] Consequently, for the purposes of this document, when it is reported in this document that the polymer is "loaded" with therapeutic agent, it means that the therapeutic agent is associated with the polymer in a manner such as those discussed above or in a related manner .
    [0090] In some cases a binder can be useful for adhering to a substrate. Examples of materials suitable for binders in connection with the present invention include silanes, titanates, isocyanates, carboxyls, amides, amines, hydroxyl and epoxide acrylates, including specific polymers such as EVA, polyisobutylene, natural rubbers, polyurethanes, siloxane coupling agents , ethylene and propylene oxides.
    [0091] It may also be useful to coat the polymer of device 201 (which may or may not contain a therapeutic agent) with an additional polymer layer (which may or may not contain a therapeutic agent). This layer can serve, for example, as a boundary layer to delay diffusion of the therapeutic agent and prevent an overflow phenomenon whereby much of the agent is released immediately upon exposure of the device or part of the device to the implant site. The material constituting the coating, or boundary layer, may or may not be the same polymer as the charged polymer. For example, the barrier layer can also be a polymer or small molecule of the following classes: polycarboxylic acids, including polyacrylic acid; cellulosic polymers, including cellulose acetate and cellulose nitrate; gelatine; polyvinylpyrrolidone; cross-linked polyvinylpyrrolidone; polyanhydrides including maleic anhydride polymers; polyamides; polyvinyl alcohols; copolymers of vinyl monomers such as EVA (vinyl ethylene acetate copolymer); polyvinyl ethers; polyvinyl aromatics; polyethylene oxides; glycosaminoglycans; polysaccharides; polyesters including polyethylene terephthalate; polyacrylamides; polyethers; polyether sulfone; polycarbonate; polyalkylene including polypropylene, polyethylene and high molecular weight polyethylene; halogenated polyalkylenes including polytetrafluoroethylene; polyurethanes; polyorthoesters; polypeptides, including proteins; silicones; siloxane polymers; polylactic acid; polyglycolic acid; polycaprolactan; polydroxybutyrate valerate and mixtures and copolymers thereof; polymer dispersion coatings such as polyurethane dispersions (BAYHDROL.RTM., etc.); fibrin; collagen and its derivatives; polysaccharides such as celluloses, starches, dextrans, alginates and derivatives; and hyaluronic acid.
    [0092] Copolymers and mixtures of those indicated above are also considered.
    [0093] It is also possible to form the aqueous humor drainage device 201 (or device part) with mixtures by adding one or more of the above or other polymers to a block copolymer. Examples include the following: - Mixtures can be formed with homopolymers that are miscible with one of the block copolymer phases. For example, polyphenylene oxide is miscible with polystyrene-polyisobutylene-polystyrene copolymer styrene blocks. This should increase the strength of a molded part or coating made of polystyrene-polyisobutylene-polystyrene copolymer and polyphenylene oxide. - Mixtures can be made with added polymers or other copolymers that are not completely miscible with the blocks of the block copolymer. The added polymer or copolymer can be advantageous, for example, in that it is compatible with another therapeutic agent, or it can change the release rate of the block copolymer therapeutic agent (for example, polystyrene-poly copolymer). isobutylene-polystyrene). - Mixtures can be made with a component such as sugar (see list above) that can be leached by device 201 (or device part), making the device or device component more porous and controlling the release rate through the porous structure .
    The rate of release of therapeutic agent from polymers loaded with the therapeutic agent of the present invention can be varied in several ways. Examples include: - Varying the molecular weight of block copolymers. - Vary the specific components selected for the elastomeric and thermoplastic parts of the block copolymers and the relative quantities of these components. - Vary the type and relative amounts of solvents used in the processing of block copolymers. - Vary the porosity of the block copolymers. - Provide a boundary layer over the block copolymer. - Mix the block copolymer with other polymers or copolymers.
    [0095] Furthermore, although it appears desirable to provide control over the release of the therapeutic agent (for example, as a quick release (hours) or as a slow release (weeks)), it may not be necessary to control the release of the therapeutic agent. In such embodiments, one or more of the therapeutic drug agents described in this document (for example, an antiproliferative agent derived from mitomycin C or 5-fluorouracil) can be injected into bag 300 at the time of surgery.
    [0096] Various types of glaucoma implant devices, kits and methods that remove aqueous humor from the anterior chamber of the eye and surgical methods associated with it have been described and illustrated in this document. Although particular embodiments of the invention have been described, it is not intended that the invention be limited to this, as it is intended that the invention be as broad in scope as the technique will allow and that the specification be read equally.
    [0097] Thus, although particular manufacturing methods have been revealed, it will be understood that other manufacturing methods can be used. For example, because the copolymer materials described in this document are of a thermoplastic nature, a variety of standard thermoplastic processing techniques can be used for the devices described in this document. Such techniques include compression molding, injection molding, blow molding, drawing, vacuum forming and calendering, and pipe extrusion and more. Such devices can also be made using solvent-based techniques involving solvent casting, spin coating, solvent spraying, dipping, fiber formation, inkjet techniques and more. Also, although it is preferred that the aqueous humor drainage device is realized by means of a simple tubular structure, it will be recognized that adaptations can be made to such structures. For example, other duct formation structures and models can be used. In another example, the device may include holes through the side wall of the tubular structure. In another example, the tubular structure can include multiple lumens in it. Also, although it is preferred that the aqueous humor drainage device is realized by means of simple flat flap structures, it will be recognized that adaptations can be made to such structures. Therefore, it will be appreciated by those skilled in the art that other modifications can also be made to the supplied invention without deviating from its spirit and scope as claimed.
    权利要求:
    Claims (13)
    [0001]
    1. Implantable device for the treatment of elevated eye pressure within the anterior chamber of the eye characterized by the fact that it comprises: a flexible tube and tissue sealing means, in which the tube defines a duct to deflect aqueous humor from the chamber above, the tube having a proximal end and distal end opposite to each other and an outer surface having a first maximum transverse dimension, and wherein the fabric sealing means includes at least one element that is spaced from the proximal and distal ends of the tube , at least one element extending radially outwardly beyond the outer surface of the tube in at least two opposite directions transverse to the central axis of the tube and having a second maximum transverse dimension greater than the first maximum transverse dimension, wherein the at least an element has a tapered distal part that extends from the tube with a profile that tapers in a transverse and outward radial direction of the central axis of the tube and the second maximum transverse dimension is defined by at least one abrupt surface of the at least one element.
    [0002]
    2. Kit for surgical treatment of elevated eye pressure inside the anterior chamber of the eye characterized by the fact that it comprises: an aqueous humor drainage device including a flexible tube and tissue sealing means, in which the tube defines a duct to deflect the aqueous humor from the anterior chamber, the tube having a proximal end and distal end opposed to each other and an outer surface having a first maximum transverse dimension, and in which the fabric sealing means include at least one element that is spaced apart from the proximal and distal ends of the tube, at least one element extending radially outwardly beyond the outer surface of the tube in at least two opposite directions transverse to the central axis of the tube and having a second maximum transverse dimension; and an instrument having a needle body for insertion through the fabric to define a passage connecting the anterior chamber, the needle body having a maximum maximum third transverse dimension along its length; wherein the first maximum transverse dimension of the outer surface of the tube is less than the third maximum transverse dimension of the needle body, and the second maximum transverse dimension of at least one element is greater than the third maximum transverse dimension in order to form a seal between the fabric and at least one element; and wherein the at least one element has a tapered distal portion extending from the tube with a profile that tapers in a transverse radial direction and outward from the central axis of the tube and the second maximum transverse dimension is defined by at least one surface abruptness of at least one element.
    [0003]
    3. Implantable device or kit according to claim 1 or 2, characterized in that the tube has a proximal portion defining a cylindrical outer surface and a distal portion defining a cylindrical outer surface, the cylindrical outer surface of the proximal part and the distal part defining the first maximum transverse dimension, and in which at least one element of the fabric sealing means is spaced apart and intermediates the cylindrical outer surfaces of the proximal and distal parts of the tube, and at least one element extends radially outwards to in addition to the cylindrical outer surfaces of the proximal and distal portions of the tube in at least two opposite directions transverse to the central axis of the tube and defines the second maximum transverse dimension.
    [0004]
    Implantable device or kit according to any one of claims 1 to 3, characterized by the fact that: the at least one element has a circular cross-section in a direction transverse to the central axis of the tube; and / or the at least one element has a cross-section broken in a direction transversal to the central axis of the tube; and / or the at least one element has an oblong cross section in a direction transverse to the central axis of the tube; and / or the at least one element has an ovoid cross section in a direction transverse to the central axis of the tube.
    [0005]
    Implantable device or kit according to any one of claims 1 to 4, characterized in that at least one element includes first and second flaps that extend radially from the tube on opposite sides of the tube and have a distal part tapered, the first tab defining a first outer edge, the second tab defining a second outer edge, where the second maximum transverse dimension is defined by the maximum distance between the first outer edge and the second outer edge.
    [0006]
    6. Implantable device or kit, according to claim 5, characterized by the fact that: the first and second tabs are mirror images of each other reflected around the central axis of the tube; and / or the first and second flaps are generally flat in shape and remain in a common plane that extends transversely in relation to the central axis of the tube; and / or the first and second flaps have a maximum thickness no more than the first maximum transverse dimension.
    [0007]
    An implantable device or kit according to any one of claims 1 to 6, characterized by the fact that: the first maximum transverse dimension is not greater than 0.4 mm; the second maximum transverse dimension is at least 0.9 mm; and the third maximum transverse dimension is in the range between 0.4 mm and 0.7 mm.
    [0008]
    8. Implantable device or kit, according to any one of claims 1 to 7, characterized by the fact that: the tube is made from a homogeneous polymeric material; and / or the aqueous humor drainage device is a single molded part made from polymeric material, which is preferably selected from the group consisting of SIBS material, silicone rubber, a polyolefin polymer, a polyurethane polymer, an acrylic polymer, a fluorine-containing polymer, a polyamide polymer, a hydrogel polymer, a bio-based structure, a soft polymer foam material, a porous polymer material and combinations thereof; and / or the polymeric material for at least a portion of the device is loaded with at least one therapeutic agent.
    [0009]
    Kit according to any one of claims 2 to 8, characterized in that it further comprises a device that includes a conduit sized to receive the tube of the aqueous humor drainage device, the conduit having a slot that allows passage the tube of the aqueous humor drainage device through it.
    [0010]
    10. Kit according to claim 9, characterized in that the slit extends along a portion of the conduit, in which a flap is arranged adjacent to a proximal end of the slit to position the conduit.
    [0011]
    11. Kit according to any one of claims 2 to 9, characterized in that it further comprises a stylus sized for insertion into the tube of the aqueous humor drainage device in order to position the aqueous humor drainage device.
    [0012]
    Kit according to any one of claims 2 to 11, characterized in that the needle body has a folded configuration.
    [0013]
    13. Kit according to any one of claims 2 to 12, characterized in that the instrument has a flat blade portion proximally arranged from the needle body, the flat blade portion having two cutting surfaces arranged on sides opposites of the flat blade part
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    法律状态:
    2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-10-08| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-07-28| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2020-11-24| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 10/01/2013, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US13/348,931|2012-01-12|
    US13/348,931|US9101444B2|2012-01-12|2012-01-12|Method, surgical kit and device for treating glaucoma|
    PCT/US2013/020920|WO2013147978A2|2012-01-12|2013-01-10|Method, surgical kit and device for treating glaucoma|
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