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`
`(12) United States Patent
`Kahook
`
`(io) Patent No.: US 10,786,391 B2
`(45) Date of Patent:
`
` *Sep. 29, 2020
`
`(54) INTRAOCULAR DEVICE FOR DUAL
`INCISIONS
`
`(71) Applicant THE REGENTS OF THE
`UNIVERSITY OF COLORADO, A
`BODY CORPORATE, Denver, CO
`(US)
`
`(72) Inventor: Malik Y. Kahook, Denver, CO (US)
`
`(73) Assignee: THE REGENTS OF THE
`UNIVERSITY OF COLORADO, A
`BODY CORPORATE, Denver, CO
`(US)
`
`Notice: Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`This patent is subject to a terminal dis-
`claimer.
`
`(21) Appl. No.: 16/678,785
`
`(22) Filed:
`
` Nov. 8, 2019
`
`(65)
`
`Prior Publication Data
`
`(58) Field of Classification Search
`CPC .. A61F 9/007; A61F 9/00736; A61F 9/00754;
`A61F 9/00781; A61F 9/013;
`(Continued)
`
`(56)
`
`
`
` References Cited
`
`U.S. PATENT DOCU MENTS
`
`2,130,949 A
`3,776,238 A
`
`9/1938 Collens
`12/1973 Peyman
`(Continued)
`
`FOREIGN PATENT DOCU MENTS
`
`EP
`EP
`
`0073803
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`
` 7/1985
`
`
` 9/2004
`(Continued)
`
`OTHER PUBLICATIONS
`
`Anderson, "Trabeculotomy compared to goniotomy for glaucoma in
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`(Continued)
`
`Primary Examiner Todd 7 Scherbel
`(74) Attorney, Agent, or Firm Morgan, Lewis &
`Bockius LLP
`
`US 2020/0129337 Al Apr. 30, 2020
`
`(57)
`
` ABSTRACT
`
`Related U.S. Application Data
`
`Continuation of application No. 15/701,306, filed on
`Sep. 11, 2017, which is a continuation of application
`(Continued)
`
` (2006.01)
`
`
` (2006.01)
`
` (2006.01)
`
`Int. Cl.
`A61F 9/013
`A61B 17/3209
`A61F 9/007
`U.S. Cl.
`CPC A61F 9/0133 (2013.01); A61B 17/3209
`(2013.01); A61F 9/00736 (2013.01); A61F
`9/00781 (2013.01)
`
`A microsurgical device and methods of its use can be used
`for treatment of various conditions including eye diseases,
`such as glaucoma, using minimally invasive surgical tech-
`niques. A dual-blade device can be used for cutting the
`trabecular meshwork ("T M") in the eye. The device tip
`provides entry into the Schlemm's canal via its size (i.e., for
`example, 0.2-0.3 mm width) and configuration where a ramp
`elevates the TM away from the outer wall of the Schlemm's
`canal and guides the TM to first and second lateral elements
`for creating first and second incisions through the TM. The
`dimensions and configuration of the blade is such that an
`entire strip of TM is removed without leaving TM leaflets
`behind and without causing collateral damage to adjacent
`tissues.
`
`20 Claims, 26 Drawing Sheets
`
`20a
`
`2 2
`
`Patent Owner Ex. 2015–0001
`
`

`

`US 10,786,391 B2
`Page 2
`
`Related U.S. Application Data
`
`No. 15/484,041, filed on Apr. 10, 2017, now Pat. No.
`9,757,279, which is a division of application No.
`15/207,329, filed on Jul. 11, 2016, now Pat. No.
`9,872,799, which is a continuation-in-part of appli-
`cation No. 14/375,350, filed as application No. PCT/
`US2013/037374 on Apr. 19, 2013, now Pat. No.
`10,327,947.
`
`(60) Provisional application No. 61/637,611, filed on Apr.
`24, 2012.
`(58) Field of Classification Search
`CPC
`A61F 9/0133; A61F 9/0136; A61F
`2009/00868; A61 B 17/3209; A61 B
`17/32093; A61B 17/3211
`See application file for co mplete search history.
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`
`* cited by exa miner
`
`Patent Owner Ex. 2015–0003
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`US 10,786,391 B2
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`1
`INTRAOCULAR DEVICE FOR DUAL
`INCISIONS
`
`RELATED APPLICATIONS
`
`The present application is a continuation of U.S. patent
`application Ser. No. 15/701,306 filed on Sep. 11, 2017,
`which is a continuation of U.S. patent application Ser. No.
`15/484,041 filed on Apr. 10, 2017, now U.S. Pat. No.
`9,757,279, issued on Sep. 12, 2017, which is a divisional of
`U.S. patent application Ser. No. 15/207,329 filed on Jul. 11,
`2016, now U.S. Pat. No. 9,872,799, issued on Jan. 23, 2018,
`which is a continuation-in-part of U.S. patent application
`Ser. No. 14/375,350 filed on Jul. 29, 2014, now U.S. Pat. No.
`10,327,947, issued on Jun. 25, 2019, which is a national
`stage entry of PCT Application No. PCT/US13/37374 filed
`on Apr. 19, 2013, which claims the benefit of U.S. Provi-
`sional Patent Application No. 61/637,611 filed on Apr. 24,
`2012, each of which is incorporated herein by reference in
`its entirety.
`
`BACKGROUND
`
`There are numerous medical and surgical procedures in
`which it is desirable to cut and remove a strip of tissue of
`controlled width from the body of a human or veterinary
`patient. For example, it may sometimes be desirable to form
`an incision of a controlled width (e.g., an incision that is
`wider than an incision made by a typical scalpel, cutting
`blade or needle) in the eye, skin, mucous membrane, tumor,
`organ or other tissue or a human or animal. In addition, it
`may sometimes be desirable to remove a strip or quantity of
`tissue from the body of a human or animal for use as a
`biopsy specimen, for chemical/biological analysis, for reten-
`tion or archival of DNA identification purposes, etc. In
`addition, some surgical procedures require removal of a strip
`of tissue of a known width from an anatomical location
`within the body of a patient.
`One surgical procedure wherein a strip of tissue of a
`known width is removed from an anatomical location within
`the body of a patient is an ophthalmological procedure used
`to treat glaucoma. This ophthalmological procedure is some-
`times referred to as a goniotomy. In a goniotomy procedure,
`a device that is operative to cut or ablate a strip of tissue of
`approximately 2-10 mm in length or more and about 50-230
`µm in width is inserted into the anterior chamber of the eye
`and used to remove a full thickness strip of tissue from the
`trabecular meshwork. The trabecular meshwork is a loosely
`organized, porous network of tissue that overlies a collecting
`canal known as Schlemm's canal. A fluid, known as aqueous
`humor, is continually produced in the anterior chamber of
`the eye. In healthy individuals, aqueous humor flows
`through the trabecular meshwork, into Schlemm's canal and
`out of the eye through a series of ducts called collector
`channels. In patients who suffer from glaucoma, the drain-
`age of aqueous humor from the eye may be impaired by
`elevated flow resistance through the trabecular meshwork,
`thereby resulting in an Increase in intraocular pressure. The
`goniotomy procedure can restore normal drainage of aque-
`ous humor from the eye by removing a full thickness
`segment of the trabecular meshwork, thus allowing the
`aqueous humor to drain through the open area from which
`the strip of trabecular meshwork has been removed.
`
`SUM MARY
`
`Embodiments of the present disclosure can be used for
`surgical medicinal intervention. For example, some embodi-
`
`2
`ments relate to a microsurgical device and methods of its use
`for treatment of various medical conditions including but not
`limited to eye diseases, such as glaucoma, using minimally
`invasive surgical techniques. Specifically, the device may be
`5 a dual-blade device for cutting the trabecular meshwork
`("TM") in the eye. In particular, the device may have a
`device tip providing entry into the Schlemm's canal via its
`size (i.e., for example, between approximately 0.2-0.3 mm
`width) and a configuration where the entry blade tip ramps
`io upwardly providing a wedge or ramp-like action for cutting
`the TM.
`To facilitate the understanding of the present disclosure, a
`number of terms are defined below.
`Terms defined herein have meanings as commonly under-
`15 stood by a person of ordinary skill in the areas relevant to the
`present disclosure. Terms such as "a," "an," and "the" are
`not intended to refer to only a singular entity, but include the
`general class of which a specific example may be used for
`illustration.
`20 As used herein, the term "patient" or "subject" refers to a
`living mammalian organism, such as a human, monkey, cow,
`sheep, goat, dog, cat, mouse, rat, guinea pig, or transgenic
`species thereof. In certain embodiments, the patient or
`subject is a primate. Non-limiting examples of human sub-
`25 jects are adults, juveniles, infants and fetuses.
`"Prevention" or "preventing" includes: (1) inhibiting the
`onset of a disease in a subject or patient which may be at risk
`and/or predisposed to the disease but does not yet experience
`or display any or all of the pathology or symptomatology of
`30 the disease, and/or (2) slowing the onset of the pathology or
`symptomatology of a disease in a subject or patient which
`may be at risk and/or predisposed to the disease but does not
`yet experience or display any or all of the pathology or
`symptomatology of the disease.
`35 The term "therapeutically effective amounts" or "phar-
`maceutically effective amounts", as used herein means that
`amount which, when administered to a subject or patient for
`treating a disease, is sufficient to effect such treatment for the
`disease or to ameliorate one or more symptoms of a disease
`40 or condition (e.g. ameliorate pain).
`As used herein, the terms "treat" and "treating" are not
`limited to the case where the subject (e.g. patient) is cured
`and the disease is eradicated. Rather, embodiments of the
`present disclosure also contemplate treatment that merely
`45 reduces symptoms, improves (to some degree) and/or delays
`disease progression. It is not intended that embodiments of
`the present disclosure be limited to instances wherein a
`disease or affliction is cured. It is sufficient that symptoms
`are reduced.
`50 As used herein "goniotomy" refers to a surgical procedure
`primarily used to treat various types of glaucoma (ex,
`primary open angle glaucoma).
`As used herein "trabecular meshwork" refers to area of
`tissue in the eye located around the base of the cornea, near
`55 the ciliary body, (between the scleral spur and Schwalbe's
`line) and is responsible for draining the aqueous humor from
`the eye via the anterior chamber (the chamber on the front
`of the eye covered by the cornea). The tissue is spongy and
`lined by trabeculocytes; it allows fluid to drain into a circular
`60 channel in the eye called Schlemm's canal and eventually
`flowing into the blood system.
`As used herein "Schlemm's canal" refers to a circular
`channel in the eye that collects aqueous humor from the
`anterior chamber and delivers it into the bloodstream via the
`65 collector channels and anterior ciliary veins.
`As used herein "eye diseases" refers to various conditions
`of the eye including, but not limited to Glaucoma —optic
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`3
`neuropathy, Glaucoma suspect —ocular hypertension, Pri-
`mary open-angle glaucoma, Primary angle-closure glau-
`coma, primary open angle glaucoma, normal or low tension
`glaucoma, pseudoexfoliation glaucoma, pigment dispersion
`glaucoma, angle closure glaucoma (acute, subacute,
`chronic), neovascular or inflammatory glaucoma, ocular
`hypertension, and other types of glaucoma that are related to
`dysregulation of intraocular pressure.
`As used herein "hypotony" refers to reduced intraocular
`pressure. The statistical definition of hypotony is intraocular
`pressure ("IOP") less than 6.5mmHg, which is more than 3
`standard deviations below the mean IOP. The clinical defi-
`nition of hypotony is IOP low enough to result in pathology
`(vision loss). The vision loss from low IOP may be caused
`by corneal edema, astigmatism, cystoid macular edema,
`maculopathy, or other condition. Hypotony maculopathy is
`characterized by a low IOP associated with fundus abnor-
`malities, including chorioretinal folds, optic nerve head
`edema in the acute setting, and vascular tortuosity.
`As used herein "Schwalbe's line" refers to the anatomical
`line found on the interior surface of the eye's cornea, and
`delineates the outer limit of the corneal endothelium layer.
`Specifically, it represents the termination of Descemet's
`membrane.
`As used herein "Descemet's membrane" refers to the
`basement membrane that lies between the corneal proper
`substance, also called stroma, and the endothelial layer of
`the cornea.
`As used herein "scleral spur" refers to an annular structure
`composed of collagen in the human eye, a protrusion of the
`sclera into the anterior chamber. It is the origin of the
`longitudinal fibers of the ciliary muscle and is attached
`anteriorly to the trabecular meshwork. Open-angle glau-
`coma (OAG) and closed-angle glaucoma (CAG) may be
`treated by muscarinic receptor agonists (e.g., pilocarpine),
`which cause rapid miosis and contraction of the ciliary
`muscles, this pulls the scleral spur and results in the trabe-
`cular meshwork being stretched and separated. This opens
`the fluid pathways and facilitates drainage of the aqueous
`humour into the canal of Schlemm and ultimately decreasing
`intraocular pressure.
`As used herein "Trabectome®" refers to a minimally
`invasive glaucoma surgical electrosurgical or ablation tool
`for the surgical management of adult, juvenile and infantile
`glaucoma. Unlike a trabeculectomy, the surgery with a
`Trabectome® should not create an external filtering bleb or
`require leaving a permanent hole in the eye. Instead, the
`Trabectome® electro- surgical handpiece opens access to the
`eyes natural drainage system.
`Embodiments of the present disclosure are illustrated, for
`example, according to various aspects described below.
`According to some embodiments, disclosed is a device for
`incising a trabecular meshwork. The device includes a shaft,
`a distal member positioned at a distal end of the shaft, the
`distal member having a forward end and a rearward end, a
`tip disposed at the forward end of the distal member, a right
`edge and a left edge extending towards the rearward end
`from the tip, wherein the right edge and the left edge
`increase in height as they extend rearward, a gap rearward
`of the tip and between the right edge and the left edge,
`wherein at least portions of the right and left edges are
`configured to cut trabecular meshwork tissue as the trabe-
`cular meshwork tissue advances in a rearward direction over
`the right and left edges, wherein as the trabecular meshwork
`tissue advances over the right and left edges, an incline of
`
`4
`the right and left edges is configured to cause the trabecular
`meshwork tissue to be lifted away from a back wall of a
`Schlemm's canal.
`According to some embodiments, disclosed is a method
`5 for incising a trabecular meshwork to form an opening in
`trabecular meshwork tissue of an eye having a Schlemm's
`Canal, an anterior chamber and a trabecular meshwork. The
`method includes inserting a distal portion of a device into the
`anterior chamber. The device includes a shaft, a distal
`io member positioned at a distal end of the shaft, the distal
`member having a forward end and a rearward end, a tip
`disposed at the forward end of the distal member, a right
`edge and a left edge extending towards the rearward end
`from the tip, wherein the right edge and the left edge
`15 increase in height as they extend rearward, and wherein a
`width between the right and left edges increases as they
`extend rearward, and a gap rearward of the tip and between
`the right edge and the left edge, wherein the distal portion
`includes the distal member. The method also includes,
`20 advancing the distal member, tip first, through the trabecular
`meshwork and into the Schlemm's Canal, and advancing the
`distal member, tip first, through the Schlemm's Canal such
`that trabecular meshwork tissue contacts, is stretched
`between, and is severed by the right and left edges of the
`25 distal member.
`According to some embodiments, disclosed is a method
`for incising a trabecular meshwork, the method comprising:
`providing a device for incising the trabecular meshwork, the
`device comprising: a platform for elevating a portion of the
`30 trabecular meshwork away from an outer wall of a
`Schlemm's canal, the platform comprising a tip at a distal
`side of the platform and a planar ramp extending from the
`distal side to a proximal side of the platform, opposite the
`distal side of the platform, wherein the ramp increases from
`35 a distal thickness at the distal side to a proximal thickness,
`greater than the distal thickness, at the proximal side; and
`first and second lateral elements for creating first and second
`incisions through the trabecular meshwork, the first and
`second lateral elements (i) being separated by a gap having
`4o a width and (ii) extending from the proximal side of the
`platform; inserting the tip into a Schlemm's canal of a
`patient; advancing the ramp between the trabecular mesh-
`work and an outer wall of the Schlemm's canal such that (i)
`a portion of the trabecular meshwork is elevated away from
`45 the outer wall of the Schlemm's canal, (ii) the portion
`remains attached to adjacent portions of the trabecular
`meshwork on opposing sides of the ramp, and (iii) the
`portion is guided to the first and second lateral elements; and
`creating first and second incisions through the trabecular
`50 meshwork with each of the first and second lateral elements
`while the trabecular meshwork is elevated away from the
`outer wall of the Schlemm's canal so a strip of the trabecular
`meshwork has a width between the first and second incisions
`corresponding to the width of the gap.
`55 Creating the first and second incisions can comprise
`creating only the first and second incisions. The strip
`between the first and second incisions remains intact after
`creating the first and second incisions. The method can
`further comprise excising the strip from the trabecular
`60 meshwork after the strip has reached a desired length. The
`excising can be performed with forceps. Creating the first
`and second incisions can be performed without ablation or
`burning of the trabecular meshwork. Creating the first and
`second incisions can be performed while the portion of the
`65 trabecular meshwork is stretched to be elevated away from
`the outer wall of the Schlemm's canal. Creating the first and
`second incisions can be performed while the portion of the
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`separated by a gap having a width and (ii) extending from
`trabecular meshwork is under tension that is greater than the
`the proximal side of the platform.
`tension of the trabecular meshwork in a natural state. The
`