i��i���u�n�u�
`
`(12> United States Patent
`Kahook
`
`(lo> Patent No.: US 10,327,947 B2
`(4s� Date of Patent:
`
`Jun. 25, 2019
`
`(54)
`
`(71)
`
`M ODIFIED DUAL-BLADE CUTTING
`SYSTE M
`
`Applic ant: 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)
`
`(58) Field of Classification Search
`CPC .. A61 F 9/007; A61 F 9/00736; A61 F 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 Wharton
`12/1973 Peyman et al.
`(Continued)
`
`FOREIGN PATENT DOCU MENTS
`
`��)
`
`Notice: Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 927 days.
`
`EP
`EP
`
`0073803 B1 7/1985
`1455698 Al 9/2004
`(Continued)
`
`(21)
`
`Appl. No.:
`
`14/375,350
`
`OTHER PUBLICATIONS
`
`(22)
`
`PCT Filed:
`
`Apr. 19, 2013
`
`(s6)
`
`PCT No.:
`
`PCT/US2013/037374
`
`§ 371 (c)(1),
`(2) Date:
`
`Jul. 29, 2014
`
`(87)
`
`PCT Pub. No.: W O2013/163034
`
`PCT Pub. Date: Oct. 31, 2013
`
`(65)
`
`Prior Publication Data
`
`US 2015/0045820 Al Feb. 12, 2015
`
`Related U.S. Application Data
`
`(60)
`
`(51)
`
`(52)
`
`Provisional application No. 61/637,611, filed on Apr.
`24, 2012.
`
`Int. C1.
`A61F 9/007
`A61F 9/013
`U.S. C1.
`CPC A61F 9/00736 (2013.01); A61F 9/00781
`(2013.01); A61F 9/0133 (2013.01)
`
` (2006.01)
`
`
` (2006.01)
`
`Anderson, D. R. (1983) "Trabeculotomy compared to goniotomy
`for glaucoma in children," Ophthalmology 90(7), 805-806.
`(Continued)
`
`Primary Examiner Todd 7 Scherbel
`(74) Attorney, Agent, or Firm Morgan, Lewis &
`Bockius LLP
`
`(57)
`
` ABSTRACT
`
`The present invention relates to a microsurgical device and
`methods of its use for treatment of various conditions
`including eye diseases, such as glaucoma, using minimally
`invasive surgical techniques. The invention relates to a
`dual-blade device 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, 0.3-0.2 mm width) and
`configuration where the blade tip curves up providing a
`ramp-like action for cutting 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.
`
`22 Claims, 24 Drawing Sheets
`
`Patent Owner Ex. 2006-0001
`
`

`

`US 10,327,947 B2
`Page 2
`
`(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.
`
`(s6)
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`Patent Owner Ex. 2006-0002
`
`

`

`US 10,327,947 B2
`Page 3
`
`(56)
`
`
`
` References Cited
`
`OTHER PUBLICATIONS
`
`PCT International Search Report of International Application No.
`PCT/US2013/037374 dated Jul. 25, 2013.
`International Search Report and Written Opinion for Application
`No. PCT/US2016/068393, dated Apr. 17, 2017, 29 pages.
`Supplementary European search report, dated Jul. 9, 2015.
`International Search Report and Written Opinion for Application
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`
`* cited by examiner
`
`Patent Owner Ex. 2006-0003
`
`

`

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`U.S. Patent Jun. 2s, 2oi9
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`

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`U.S. Patent Jun. 2s, 2oi9
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`Increased platform thickness extending
`back from tip towards back side of L?ETAIL B
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`Patent Owner Ex. 2006-0021
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`U.S. Patent Jun. 2s, 2oi9
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`Sheet 19 of 24
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`©ual Blade Device
`
`Patent Owner Ex. 2006-0022
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`U.S. Patent Jun. 2s, 20><9
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`The angle between the handle and the
`ramp is important and should be
`between 90 and 12g degrees.
`
`There is a second angle between the
`handle and the ramp that is not
`illustrated here.
`The ramp does not only form an angle
`with the handle as shown in the picture
`to the right. it also forms an angle in
`the z-axis.
`The pivot is at the "'#" away from the
`page as viewed.
`
`The ramp: A is the part that pierces the B
`tissue and then the tissue moves uq
`the ramp from a to B. The blades ('')
`then meet the tissue and cut as the
`device is advanced.
`
`F� 23
`
`Patent Owner Ex. 2006-0026
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`

`

`This is the anatomy of interest.
`(Crass section of the eye)
`The handle is in the eye and going across to the
`opposite side Schlemm's canal outlined by a
`circle.. The angle between the handle and the
`ramp, shown previously, will allow the blade to
`enter Schlemm's canal and cut
`tissue.
`In this figure that first angle could make the
`ramp come out towards the viewer. However, a
`second angle would also need to exist that
`#ollaws the black lines to allow the device to
`also #it in the angle space of Schlemm's canal.
`
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`US 10,327,947 B2
`
`1
`MODIFIED DUAL-BLADE CUTTING
`SYSTE M
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`The present application claims the benefit of U.S. Provi-
`sional Patent Application No. 61/637,611, filed on. Apr. 24,
`2012, which is incorporated herein by reference [1].
`
`FIELD OF THE INVENTION
`
`This invention is in the field of surgical medicinal inter-
`vention. For example, the present invention relates 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 sur-
`gical techniques. Specifically, the device may be a dual-
`blade device for cutting the trabecular meshwork (T M) 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 0.3-0.2 mm width) and
`a configuration where the entry blade tip curves up provid-
`ing a ramp-like action for cutting the TM.
`
`BACKGROUND OF THE INVENTION
`
`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-
`timesreferred to as a goniotomy. In a gonioctomy 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 50-200
`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 normal 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 drainage 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 gonioc-
`tomy procedure can restore normal drainage of aqueous
`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. The gonioctomy
`
`2
`procedure and certain prior art instruments useable to per-
`form such procedure are described In U. S. patent application
`Ser. No. 10/052,473 issued as U.S. Pat. No. 6,979,328
`(Baerveldt) [2], the entirety of which is expressly incorpo-
`5 rated herein by reference.
`At present there remains a need in the art for the devel-
`opment of simple, inexpensive and accurate instruments
`useable to perform the procedure of cutting the trabecular
`meshwork (T M) in the eye and effectively remove a com-
`io plete full thickness strip of TM without leaving TM leaflets
`as well as other procedures where it is desired to remove a
`strip of tissue from a larger mass of tissue.
`
`SUM MARY OF THE INVENTION
`
`15
`
`This invention is in the field of surgical medicinal inter-
`vention. For example, the present invention relates to a
`microsurgical device and methods of its use for treatment of
`various medical conditions including but not limited to eye
`20 diseases, such as glaucoma, using minimally invasive sur-
`gical techniques. Specifically, the device may be a dual-
`blade device for cutting the trabecular meshwork (T M) in
`the eye. In particular, the device may have a device tip
`providing entry into the Schlemm's canal via its size (i.e.,
`25 for example, between approximately 0.3-0.2 mm width) and
`a configuration where the entry blade tip curves up provid-
`ing a ramp-like action for cutting the TM.
`In one embodiment, the invention relates to a device
`comprising: a handle 1, interface of tool shaft and handle 2,
`so a tool shaft 3, interface of tool shaft and beveled platform 4,
`beveled platform 5, a first end/beveled platform tip/insertion
`blade tip 6, a second end/back of the beveled platform 7, a
`first side 8, a second side 9, a first blade 10, and a second
`blade 11.
`ss In one embodiment, the invention relates to a device 12
`comprising: a handle 1 that necks down to a tool shaft 3 by
`a first interface 2 wherein said tool shaft widens into a
`beveled platform 5 by a second interface 4, wherein said
`beveled platform comprises a insertion blade tip 6 on a distal
`4o end of the beveled platform comprising a ramp from said
`insertion blade tip back towards the posterior end the
`beveled platform, and a first lateral blade 10 and second
`lateral blade 11 along the sides of said beveled platform. In
`one embodiment, said sides of said beveled platform com-
`45 prise a first side 8 and a second side 9. In one embodiment,
`said first lateral blade 10 and second lateral blade 11 are in
`a perpendicular alignment to the bottom of the beveled
`platform. In one embodiment, the the platform 5 is set at a
`specific angle and orientation relative to said handle 1. In
`so one embodiment, the platform 5 freely rotates in at least two
`dimensions. In one embodiment, said handle 1 and beveled
`platform 5 are operably attached at an angle ranging
`between 90 and 120 degrees in the Y-Z axis. In one embodi-
`ment, said handle 1 and beveled platform 5 are operably
`55 attached at an angle ranging between 90 and 180 degrees in
`the X-Z axis. In one embodiment, said platform 5 freely
`rotates in an X-Y dimension relative to said handle 1. In one
`embodiment, said platform 5 remains at a fixed angle in the
`X-Y, X-Z, and Y-Z dimensions relative to said handle 1. In
`60 one embodiment, said platform 5 freely rotates in a positive
`Z dimension relative to said handle 1. In one embodiment,
`said beveled platform 5 comprises a first end/beveled plat-
`form tip/insertion blade tip 6 and a second end/back of the
`beveled platform 7, wherein said second end/back of the
`65 beveled platform 7 is between 2 and 30 greater in thickness
`relative to the thickness of said first end/beveled platform
`tip/insertion blade tip 6. In one embodiment, the dimensions
`
`Patent Owner Ex. 2006-0028
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`

`US 10,327,947 B2
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`3
`of the beveled platform 5 are calculated using the formula
`A�+B� ��, wherein A is the length of said beveled platform
`5 from said insertion blade tip 6 to the back of the beveled
`platform 7, B is the height of the beveled platform 5 and C
`is the length of the ramp formed by the beveled platform
`insertion blade tip up to the height of said beveled platform.
`In one embodiment, the height of said beveled platform 5 is
`not to exceed 0.5 millimeters . In one embodiment, the length
`of said beveled platform 5 from said insertion blade tip 6 to
`the back of the beveled platform 7 is not to exceed 1.0
`millimeters. In one embodiment, the width of said beveled
`platform 5 is not to exceed 0.35 millimeters . In one embodi-
`ment, said beveled platform 5 increases in thickness from a
`fine blade tip towards the second end/back of the beveled
`platform 7 in the direction of the Y-axis. In one embodiment,
`said first end beveled platform tip/insertion blade tip 6
`comprises a pointed tip with fine edges of surgical sharp-
`ness. In one embodiment, said first end beveled platform
`tip/insertion blade tip 6 comprises a lancet. In one embodi-
`ment, said beveled platform 5 further comprises a first blade
`10 and a second blade 11. In one embodiment, said first
`blade 10 is attached to a first side 8 of said second end/back
`of the beveled platform 7. In one embodiment, said first
`blade 10 and beveled platform 5 are operably attached at an
`angle ranging between 90 and 180 degrees in the Y-Z axis.
`In one embodiment, said angle is preferably between 90 and
`120 degrees in the Y-Z axis. In one embodiment, said second
`blade 11 and beveled platform 5 are operably attached at an
`angle ranging between 90 and 120 degrees in the Y-Z axis.
`In one embodiment, said first blade 10 and handle 1 are
`operably positioned at an angle ranging between 90 and 120
`degrees in the Y-Z axis. In one embodiment, said second
`blade 11 and handle 1 are operably positioned at an angle
`ranging between 90 and 120 degrees in the Y-Z axis. In one
`embodiment, said second blade 11 is attached to a second
`side 9 of said second end/back of the beveled platform 7. In
`one embodiment, said beveled platform 5 increases in thick-
`ness from said second side 9 towards the first side 8 in the
`direction of the X-axis. In one embodiment, said beveled
`platform 5 increases in thickness from said first side 8
`towards the second side 9 in the direction of the X-axis. In
`one embodiment, said beveled platform 5 increases in thick-
`ness from said second side 9 towards the first side 8 in the
`direction of the X-axis and said beveled platform 5 increases
`in thickness from a fine blade tip of the first end 6 towards
`the second end/back of the beveled platform 7 in the
`direction of the Y-axis. In one embodiment, said beveled
`platform 5 increases in thickness from said first side 8
`towards the second side 9 in the direction of the X-axis and
`said beveled platform 5 increases in thickness from a fine
`blade tip of the first end 6 towards the second end/back of
`the beveled platform 7 in the direction of the Y-axis. In one
`embodiment, said first blade 10 and said second blade ll are
`parallel . In one embodiment, said first blade 10 and said
`second blade 11 extend above the top surface of said second
`end/back of the beveled platform 7. In one embodiment, said
`first blade 10 and said second blade 11 are positioned at an
`angle between approximately 100 to 140 degrees relative to
`the top surface of said second end/back of the beveled
`platform 7. In one embodiment, said beveled platform 5 is
`approximately 0.3 millimeters wide. In one embodiment,
`said beveled platform 5 is approximately 0.2 millimeters
`wide. In a preferred embodiment, said beveled platform 5 is
`approximately 0.25 millimeters wide.
`In one embodiment, the invention relates to a device
`comprising a handle and a beveled platform, wherein said
`platform freely rotates in at least two dimensions. In one
`
`4
`embodiment, said handle and beveled platform are operably
`attached at an angle ranging between 90 and 120 degrees. In
`one embodiment, said platform freely rotates in an X-Y
`dimension relative to said handle. In one embodiment, said
`5 platform freely rotates in a positive Z dimension relative to
`said handle. In one embodiment, said beveled platform
`comprises a first end and a second end, wherein said second
`end is at least 20 times greater in thickness relative to said
`first end. In one embodiment, said beveled platform further
`io comprises a first blade and a second blade. In one embodi-
`ment, said first blade is attached to a first side of said second
`end. In one embodiment, said second blade is attached to a
`second side of said second end. In one embodiment, said first
`blade and said second blade are parallel . In one embodiment,
`is said first blade and said second blade extend above the top
`surface of said second end. In one embodiment, said first
`lateral blade and said second lateral blade are positioned at
`an angle between approximately 100-140 degrees in the Y-Z
`axis relative to the bottom surface of said beveled platform.
`20 In one embodiment, said beveled platform is approximately
`0.3 millimeters wide. In one embodiment, said beveled
`platform 5 is approximately 0.2 millimeters wide. In a
`preferred embodiment, said beveled platform 5 is approxi-
`mately 0.25 millimeters wide.
`25 In one embodiment, said beveled platform is set at a
`specific angle and orientation relative to said handle. In one
`embodiment, said handle and beveled platform are operably
`attached at an angle ranging between 90 and 120 degrees in
`the Y-Z axis. In one embodiment, said handle and beveled
`so platform are operably attached at an angle ranging between
`90 and 180 degrees in the X-Z axis. In one embodiment, said
`platform freely rotates in an X-Y dimension relative to said
`handle. In one embodiment, said platform remains at a fixed
`angle in the X-Y, X-Z, and Y-Z dimensions relative to said
`ss handle. In one embodiment, said platform freely rotates in a
`positive Z dimension relative to said handle. In one embodi-
`ment, the dimensions of the beveled platform are calculated
`by the formula A�+B�=C�, wherein A is the length of said
`beveled platform from said beveled platform insertion blade
`4o tip to the posterior end of the beveled platform, B is the
`height of the beveled platform and C is the length of the
`ramp formed by the beveled platform insertion blade tip up
`to the height of said beveled platform. In one embodiment,
`the height of said beveled platform is not to exceed 0.5
`45 millimeters . In one embodiment, the length of said beveled
`platform from said beveled platform insertion blade tip to
`the posterior end of the beveled platform is not to exceed 1.0
`millimeters. In one embodiment, the height of said beveled
`platform is greater than 0.5 millimeters. In one embodiment,
`so the length of said beveled platform from said beveled
`platform insertion blade tip to the posterior end of the
`beveled platform is greater than 1.0 millimeters. In one
`embodiment, the width of said beveled platform 5 is not to
`exceed 0.35 millimeters. In one embodiment, said beveled
`55 platform 5 is approximately 0.2 millimeters wide. In a
`preferred embodiment, said beveled platform 5 is approxi-
`mately 0.25 millimeters wide. In one embodiment, said
`beveled platform increases in thickness from a fine blade tip
`towards the posterior end of the beveled platform in the
`6o direction of the Y-axis. In one embodiment, said beveled
`platform insertion blade tip comprises a pointed tip with fine
`edges of surgical sharpness . In one embodiment, said bev-
`eled platform insertion blade tip comprises a lancet. In one
`embodiment, said beveled platform further comprises a first
`65 lateral blade and a second lateral blade. In one embodiment,
`said first lateral blade is attached to a first side of said
`posterior end of the beveled platform. In one embodiment,
`
`Patent Owner Ex. 2006-0029
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`US 10,327,947 B2
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`5
`said first lateral blade and beveled platform are operably
`attached at an angle ranging between 90 and 180 degrees in
`the Y-Z axis. In one embodiment, said angle is preferably
`between 90 and 120 degrees in the Y-Z axis. In one embodi-
`ment, said second blade and beveled platform are operably
`attached at an angle ranging between 90 and 120 degrees in
`the Y-Z axis. In one embodiment, said first lateral blade and
`handle are operably positioned at an angle ranging between
`90 and 120 degrees in the Y-Z axis. In one embodiment, said
`second lateral blade and handle are operably positioned at an
`angle ranging between 90 and 120 degrees in the Y-Z axis.
`In one embodiment, said second lateral blade is attached to
`a second side 9 of said posterior end of the beveled platform.
`In one embodiment, said beveled platform increases in
`thickness from said second side towards the first side in the
`direction of the X-axis. In one embodiment, said beveled
`platform increases in thickness from said first side towards
`the second side in the direction of the X-axis. In one
`embodiment, said beveled platform increases in thickness
`from said second side towards the first side in the direction
`of the X-axis and said beveled platform increases in thick-
`ness from a fine blade tip of the beveled platform insertion
`blade tip towards the posterior end of the beveled platform
`in the direction of the Y-axis. In one embodiment, said
`beveled platform increases in thickness from said first side
`towards the second side in the direction of the X-axis and
`said beveled platform increases in thickness from a fine
`blade tip of the beveled platform insertion blade tip towards
`the posterior end of the beveled platform in the direction of
`the Y-axis. In one embodiment, said first lateral blade and
`said second lateral blade are parallel. In one embodiment,
`said first lateral blade and said second lateral blade extend
`above the top surface of said posterior end of the beveled
`platform. In one embodiment, said first lateral blade and said
`second lateral blade are positioned at an angle between
`approximately 100 to 140 degrees in the Y-Z axis relative to
`the bottom surface of said posterior end of the beveled
`platform. In one embodiment, said beveled platform is
`approximately 0.3 millimeters wide. In one embodiment,
`said beveled platform 5 is approximately 0.2 millimeters
`wide. In a preferred embodiment, said beveled platform 5 is
`approximately 0.25 millimeters wide. In one embodiment,
`said device is integrated into an endoscope. In one embodi-
`ment, said device is placed on the end of the endoscope. In
`one embodiment, said device is made from at least one of the
`following materials: titanium, stainless steel, polyether ether
`ketone, shape memory alloy, and shape memory polymers.
`In one embodiment, said device is rigid at room temperature,
`but is more flexible at body temperature. In one embodi-
`ment,portions of the device of the current invention are rigid
`at room temperature, but are more flexible at body tempera-
`ture. In one embodiment, portions of the device are made
`from different materials. In one embodiment, portions of the
`device are made from materials of various rigidity. In one
`embodiment, said tool shaft is flexible. In one embodiment,
`said tool shaft is made from a lower density material.
`In one embodiment, the invention relate to a method for
`cutting a strip of tissue of width W from a tissue mass, said
`method comprising the steps of: a) providing a device which
`comprises; i) a handle attached to a beveled platform, ii) an
`anterior insertion blade tip of the beveled platf