JP7685496B2 - Ophthalmic knife - Google Patents

Description

This application is a continuation-in-part of U.S. Patent Application No. 16/015,078, filed on June 21, 2018 and issued on May 19, 2020 as U.S. Patent No. 10,653,558, which is a continuation-in-part of U.S. Patent Application No. 15/389,328, filed on December 22, 2016 and issued on February 26, 2019 as U.S. Patent No. 10,213,342, which was a non-provisional application and claim of U.S. Provisional Patent Application No. 62/387,351, filed on December 23, 2015, entitled "Ophthalmic Knife and Method of Use."

The present invention relates to an ophthalmic knife and method of use for treating various conditions, including ophthalmic diseases such as glaucoma, using minimally invasive surgical techniques. The ophthalmic knife can be used to cut tissue within the eye, such as the trabecular meshwork (TM). The present invention also relates to surgical medical interventions. For example, the present invention relates to a microsurgical device and method of use for treating various medical conditions, including, but not limited to, ophthalmic diseases such as glaucoma, using minimally invasive surgical techniques.

There are numerous medical and surgical procedures in which it is desirable to cut and remove strips of tissue of controlled width from the body of a human or veterinary patient. For example, it may be desirable to make incisions of controlled width (e.g., incisions wider than those made by a typical scalpel, cutting blade, or needle) in the eye, skin, mucosa, tumor, organ, or other tissue of a human or animal. Additionally, it may be desirable to remove a strip or amount of tissue from the human or animal body for use as a biopsy specimen, chemical/biological analysis, retention or archiving for DNA identification purposes, etc. Additionally, some surgical procedures require the removal of strips of tissue of known width from anatomical locations within the patient's body. One surgical procedure in which strips of tissue of known width are removed from anatomical locations within the patient's body is an ophthalmology procedure used to treat glaucoma. This ophthalmology procedure is sometimes referred to as a goniotomy. In a goniotomy procedure, a device operating to cut or ablate a strip of tissue about 2-10 mm or more in length 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. Currently, there remains a need in the art for the development of a simple, inexpensive, and precise instrument that can be used to perform procedures that cut the trabecular meshwork (TM) of the eye and effectively remove an entire full-thickness strip of TM without leaving any TM leaflets behind, as well as other procedures in which it is desired to remove a strip of tissue from a larger mass of tissue.

U.S. Patent No. 7,959,641 WO 2004/110501 US Patent Publication No. 2007/0276420 US Patent Publication No. 2009/0287233 US Patent Publication No. 2011/0077626 U.S. Patent No. 7,785,321 U.S. Patent No. 6,979,328 US Patent Publication No. 2006/0106370 US Patent Publication No. 2002/0111608 International Publication No. 2009/140185 European Patent No. 2303203 International Publication No. 2001/078631 U.S. Pat. No. 4,501,274 European Patent No. 0073803 US Patent Publication No. 2006/0149194 International Publication No. WO 2003/045290 European Patent No. 1455698 Korean Patent No. 1020040058309 US Patent Publication No. 2007/0073275 International Publication No. 2004/093761 European Patent No. 1615604 US Patent Publication No. 2011/0230877 International Publication No. 2013/163034

Pantcheva, M. B. and Kahook, M. Y. (2010) “Ab Interno Trabeculectomy”, Middle East Afr. J. Ophthalmol. 17(4), pp. 287-289(10)

The present invention relates to an ophthalmic knife and method of use thereof for treating various conditions, including ocular diseases such as glaucoma, using minimally invasive surgical techniques. The ophthalmic knife can be used to cut tissue within the eye, for example, the trabecular meshwork (TM). The present invention also relates to surgical medical interventions. For example, the present invention relates to a microsurgical device and method of use thereof for treating various medical conditions, including, but not limited to, ocular diseases such as glaucoma, using minimally invasive surgical techniques.

In one embodiment, the present invention contemplates a dual platform/dual blade ophthalmic knife having a handle connected to a shaft, the shaft connected to a first platform and a second platform, the first platform having first and second blades and a first forward blade tip, and the second platform having third and fourth blades and a second forward blade tip. In one embodiment, the forward blade tip is a retractable or collapsible blade tip. In one embodiment, the first and second forward blade tips are retractable or collapsible blade tips. In one embodiment, the forward blade tip is a wedge blade tip. In one embodiment, the first and second blades are attached to a first and second lateral side (respectively) of the first platform. In one embodiment, the third and fourth blades are attached to a third and fourth lateral side (respectively) of the second platform. In one embodiment, the first and second platforms are configured at an angle of 180°. In one embodiment, the blade tips have a right angle triangle. In one embodiment, the right triangle follows the Pythagorean theorem equation ( ^a2 + ^b2 = ^c2 ), where the sides of the tip have lengths a and b, and the hypotenuse has a length of c.8. In one embodiment, the platforms each have a slope. In one embodiment, the distal ends of the platforms slope upward from the perforating blade to a parallel blade. In one embodiment, the distal ends of the platforms slope upward from the perforating blade to a parallel blade positioned above the level of the TM. In one embodiment, the first and second platforms are offset. In one embodiment, the first and second platforms are parallel. In one embodiment, the first platform has a first slope of increasing depth extending from a first forward blade tip to a first rear end. In one embodiment, the second platform has a second slope of increasing depth extending from a second forward blade tip to a second rear end. In one embodiment, the first and second blades are parallel. In one embodiment, the first and second blades are at an angle. In one embodiment, the platform has an annular cutting edge. In one embodiment, the third and fourth blades are parallel. In one embodiment, the third and fourth blades are at an angle. In one embodiment, the first platform has an annular cutting edge. In one embodiment, the second platform has an annular cutting edge. In one embodiment, the first and second lateral blades are retractable and mounted within the first and second platform cavities (respectively). In one embodiment, the third and fourth lateral blades are retractable and mounted within the third and fourth platform cavities (respectively). In one embodiment, the handle includes a lateral blade actuator switch in operative communication with the first, second, third and fourth platform cavities. In one embodiment, the platform further includes a gripping feature. In one embodiment, the parallel dual platforms can be actuated to grip tissue together. In one embodiment, the gripping feature includes, but is not limited to, a tweezer element or a forceps element. In one embodiment, the parallel dual platforms can be actuated to grip tissue together. In one embodiment, the gripping features include a sleeve extending over the shaft, where the handle includes a sleeve actuator switch. In one embodiment, the gripping features are made of a shape memory material that is retractable into a lumen of the device. In one embodiment, the platform further includes a slidable punch that can detach tissue from the multi-blade device. In one embodiment, the multi-blade device further includes at least one lumen extending longitudinally within the handle, shaft, and platform. In one embodiment, the lumen has an outlet in the platform. In one embodiment, the outlet is on a top surface of the platform. In one embodiment, the outlet is on a bottom surface of the platform. In one embodiment, the lumen has an inlet in the handle. In one embodiment, the lumen includes a viscoelastic fluid. In one embodiment, the lumen includes an aspirating fluid. In one embodiment, the platform further includes a through hole extending from the top surface to the rear end. In one embodiment, the handle is curved. In one embodiment, the device further includes a fiber optic visualization system. In one embodiment, the platform has a width of about 150-180 microns. In one embodiment, the platform is a color including, but not limited to, blue, white, black, orange, and yellow, or any combination thereof. In one embodiment, the platform has a concave bottom surface. In one embodiment, the shaft includes an annular ring. In one embodiment, the platform further includes at least one heating element. In one embodiment, the shaft is a telescoping shaft.

In one embodiment, the present invention contemplates a quad-blade ophthalmic knife having a handle connected to a shaft and said shaft connected to a platform having four cutting blades and a forward blade tip. In one embodiment, the forward blade tip is a retractable or retractable blade tip. In one embodiment, the forward blade tip is a wedge blade tip. In one embodiment, the platform has a first blade and a second blade attached (respectively) to a first lateral side and a second lateral side of the platform. In one embodiment, the blade tips have a right triangle. In one embodiment, the right triangle follows the Pythagorean theorem equation ( ^a2 + ^b2 = ^c2 ), where both sides of the tip have lengths a and b, and the hypotenuse has a length c. In one embodiment, the platform includes a slope. In one embodiment, the distal end of the platform slopes upward from the perforating blade to the parallel blade. In one embodiment, the distal end of the platform slopes upward from the perforating blade to a parallel blade positioned above the level of the TM. In one embodiment, the shaft further comprises a third blade and a fourth blade attached to a first lateral side and a second lateral side, respectively, of the shaft. In one embodiment, the third and fourth blades are slidably engaged with the shaft. In one embodiment, the handle comprises a compressible material in contact with the third and fourth blades. In one embodiment, the shaft is connected to a second quad-blade knife positioned at an angle of 180° from the first quad-blade knife. In one embodiment, the shaft is connected to the second quad-blade knife at a position parallel to the first quad-blade knife. In one embodiment, the platform comprises a slope of increasing depth extending from a forward blade tip to a rear end. In one embodiment, the first and second blades are parallel. In one embodiment, the first and second blades are at an angle. In one embodiment, the platform has an annular cutting edge. In one embodiment, the first and second lateral blades are retractable and mounted within the first and second platform cavities (respectively). In one embodiment, the handle comprises a lateral blade actuator switch in operable communication with the first and second platform cavities. In one embodiment, the platform further comprises a gripping arrangement. In one embodiment, the gripping arrangement includes, but is not limited to, a tweezers or forceps element. In one embodiment, the gripping arrangement comprises a sleeve extending over the shaft, where the handle comprises a sleeve actuator switch. In one embodiment, the platform further comprises a slidable punch capable of detaching tissue from the multi-blade device. In one embodiment, the multi-blade device further comprises at least one lumen extending longitudinally within the handle, shaft and platform. In one embodiment, the lumen comprises an outlet in the platform. In one embodiment, the outlet is on a top surface of the platform. In one embodiment, the outlet is on a bottom surface of the platform. In one embodiment, the lumen comprises an inlet in the handle. In one embodiment, the lumen comprises a viscoelastic fluid. In one embodiment, the lumen comprises an aspirating fluid. In one embodiment, the platform further comprises a through hole extending from the top surface to the rear end. In one embodiment, the handle is curved. In one embodiment, the device further comprises a fiber optic visualization system. In one embodiment, the platform has a width of about 150-180 microns. In one embodiment, the platform is a color including, but not limited to, blue, white, black, orange, and yellow, or any combination thereof. In one embodiment, the platform has a concave bottom surface. In one embodiment, the shaft comprises an annular ring. In one embodiment, the platform further comprises at least one heating element. In one embodiment, the shaft is a telescoping shaft.

In one embodiment, the present invention contemplates an ultrasonic ophthalmic knife having a handle, a shaft, a forward blade tip, and a platform, where the platform has a foot plate that protects surrounding tissue from the ultrasound emitter and the ultrasonic blade. In one embodiment, the ultrasound emitter forward blade tip vibrates at a fixed frequency when the device is activated. In one embodiment, both longitudinal and lateral motion is possible for the tip. In one embodiment, the ultrasound emitter has an adjustable power setting. In one embodiment, the power setting is optimized to minimize application of heat during use. The ultrasonic knife allows for tissue cutting while reducing the need to pre-stretch or tension the tissue. The knife tip vibrates at a fixed frequency when the device is activated. Both longitudinal and lateral motion is possible for the tip. The power setting is optimized to minimize application of heat to the tissue. In one embodiment, the forward blade tip is a wedge blade tip. In one embodiment, the forward blade tip is a retractable blade tip. In one embodiment, the blade tip has a right angle triangle shape. In one embodiment, the right triangle follows the Pythagorean theorem equation ( ^a2 + ^b2 = ^c2 ), where the distal sides have lengths a and b, and the hypotenuse has a length c. In one embodiment, the platform includes a beveled surface. In one embodiment, the distal end of the platform slopes upward from the perforating blade to a parallel blade. In one embodiment, the distal end of the platform slopes upward from the perforating blade to a parallel blade positioned above the level of the TM. In one embodiment, the platform further includes a gripping structure. In one embodiment, the gripping structure includes, but is not limited to, tweezers or forceps elements. In one embodiment, the gripping structure includes a sleeve extending over the shaft, where the handle includes a sleeve actuator switch. In one embodiment, the platform further includes a slidable punch capable of detaching tissue from the ultrasonic knife. In one embodiment, the ultrasonic device further includes at least one lumen extending longitudinally within the handle, shaft, and platform. In one embodiment, the lumen has an outlet at said platform. In one embodiment, the outlet is on a top surface of the platform. In one embodiment, the outlet is on a bottom surface of the platform. In one embodiment, the lumen has an inlet at said handle. In one embodiment, the lumen comprises a viscoelastic fluid. In one embodiment, the lumen comprises an aspiration fluid. In one embodiment, the platform further comprises a through hole extending from the top surface to the rear end. In one embodiment, the handle is curved. In one embodiment, the ultrasound device further comprises a fiber optic visualization system. In one embodiment, the platform has a width of about 150-180 microns. In one embodiment, the platform is a color including, but not limited to, blue, white, black, orange, and yellow, or any combination thereof. In one embodiment, the platform has a concave bottom surface. In one embodiment, the shaft has an annular ring. In one embodiment, the platform further comprises at least one heating element. In one embodiment, the shaft is a telescoping shaft.

In one embodiment, the present invention contemplates a pincer ophthalmic knife having a handle connected to a shaft, said shaft connected to a lower platform and an upper platform. In one embodiment, the lower platform includes a forward blade tip. In one embodiment, the forward blade tip is a wedge blade tip. In one embodiment, the shaft and the upper platform are connected by a hinge. In one embodiment, the lower platform has a first lateral side attached to a first blade and a second lateral side attached to a second blade. In one embodiment, the upper platform has a first slot and a second slot, where the first and second slots are positioned above said first and second blades. In one embodiment, the lower platform further comprises a forward blade tip. In one embodiment, said blade tip comprises a right triangle. In one embodiment, said right triangle follows the Pythagorean theorem formula ( ^a2 + ^b2 = ^c2 ), where both sides of said tip have lengths a and b, and the length of the hypotenuse is c. In one embodiment, said platform comprises a slope. In one embodiment, the distal end of the platform slopes upward from the perforating blade to a parallel blade. In one embodiment, the distal end of the platform slopes upward from the perforating blade to a parallel blade positioned above the level of the TM. In one embodiment, the lower platform is at least 8 mm long. In one embodiment, the platform further comprises a gripping arrangement. In one embodiment, the gripping arrangement includes, but is not limited to, a tweezers element or a forceps element. In one embodiment, the gripping arrangement comprises a sleeve extending over the shaft, where the handle comprises a sleeve actuator switch. In one embodiment, the platform further comprises a slidable punch capable of detaching tissue from the pincer ophthalmic knife. In one embodiment, the pincer ophthalmic knife device further comprises at least one lumen extending longitudinally within the handle, shaft and platform. In one embodiment, the lumen has an outlet in the platform. In one embodiment, the outlet is on a top surface of the platform. In one embodiment, the outlet is on a bottom surface of the platform. In one embodiment, the lumen has an inlet in the handle. In one embodiment, the lumen comprises a viscoelastic fluid. In one embodiment, the lumen comprises an aspiration fluid. In one embodiment, the platform further comprises a through hole extending from the top surface to the rear end. In one embodiment, the handle is curved. In one embodiment, the pincer ophthalmic knife device further comprises a fiber optic visualization system. In one embodiment, the platform has a width of about 150-180 microns. In one embodiment, the platform is a color including, but not limited to, blue, white, black, orange, and yellow, or any combination thereof. In one embodiment, the platform has a concave bottom surface. In one embodiment, the shaft comprises an annular ring. In one embodiment, the platform further comprises at least one heating element. In one embodiment, the shaft is a telescoping shaft.

In one embodiment, the present invention contemplates a grip-type ophthalmic knife having a handle connected to a shaft, the shaft including a first lateral alligator clip and a second lateral alligator clip, a platform connected to the shaft, the platform having a first lateral blade and a second lateral blade, and a forward blade tip. In one embodiment, the forward blade tip is a wedge blade tip. In one embodiment, the forward blade tip is a retractable blade tip. In one embodiment, the blade tip has a right triangle. In one embodiment, the right triangle follows the Pythagorean theorem formula ( ^a2 + ^b2 = ^c2 ), where both sides of the tip have lengths a and b, and the length of the hypotenuse is c. In one embodiment, the platform has a slope. In one embodiment, the distal end of the platform slopes upward from the perforating blade to a parallel blade. In one embodiment, the distal end of the platform slopes upward from the perforating blade to a parallel blade positioned above the level of the TM. In one embodiment, the first and second lateral blades are attached to the first and second lateral sides (respectively) of the platform. In one embodiment, the first lateral alligator clip has a first serrated jaw and a second serrated jaw. In one embodiment, the second lateral alligator clip has a first serrated jaw and a second serrated jaw. In one embodiment, the first and second serrated jaws of the first lateral alligator clip are hinged. In one embodiment, the first and second serrated jaws of the second lateral alligator clip are hinged. In one embodiment, the handle comprises a compressible material in contact with the first and second alligator clips. In one embodiment, the platform further comprises a gripping arrangement. In one embodiment, the gripping arrangement includes, but is not limited to, tweezers or forceps elements. In one embodiment, the gripping arrangement comprises a sleeve extending over the shaft, where the handle comprises a sleeve actuator switch. In one embodiment, the platform further comprises a slidable punch capable of detaching tissue from the multi-blade device. In one embodiment, the multi-blade device further comprises at least one lumen extending longitudinally within said handle, shaft and platform. In one embodiment, the lumen has an outlet in said platform. In one embodiment, the outlet is on a top surface of the platform. In one embodiment, the outlet is on a bottom surface of the platform. In one embodiment, the lumen has an inlet in said handle. In one embodiment, the lumen contains a viscoelastic fluid. In one embodiment, the lumen contains an aspiration fluid. In one embodiment, the platform further comprises a through hole extending from the top surface to the rear end. In one embodiment, the handle is curved. In one embodiment, the device further comprises a fiber optic visualization system. In one embodiment, the platform has a width of about 150-180 microns. In one embodiment, the platform is a color including, but not limited to, blue, white, black, orange and yellow, or any combination thereof. In one embodiment, the platform has a concave bottom surface. In one embodiment, the shaft has an annular ring. In one embodiment, the platform further comprises at least one heating element. In one embodiment, the shaft is a telescoping shaft.

In one embodiment, the present embodiment contemplates a lancet ophthalmic knife having a handle connected to a shaft and the shaft connected to a wire element. In one embodiment, the wire element has a geometric shape including, but not limited to, a triangle, a square, a rectangle, an octagon, a circle, an ellipse, or an oval. In one embodiment, the wire element has a first wire end and a second wire end. In one embodiment, the first wire end is connected to the shaft at a first location. In one embodiment, the second wire end is connected to the shaft at a second location. In one embodiment, the shaft further comprises a gripping arrangement. In one embodiment, the gripping arrangement includes, but is not limited to, a tweezers element or a forceps element. In one embodiment, the gripping arrangement comprises a sleeve extending over the shaft, where the handle comprises a sleeve actuator switch. In one embodiment, the shaft further comprises a slidable punch capable of detaching tissue from the wire element. In one embodiment, the lancet knife further comprises at least one lumen extending longitudinally within the handle and the shaft. In one embodiment, the lumen comprises an outlet in the shaft. In one embodiment, the lumen has an inlet in said handle. In one embodiment, the lumen contains a viscoelastic fluid. In one embodiment, the lumen contains an aspiration fluid. In one embodiment, the handle is curved. In one embodiment, the device further comprises a fiber optic visualization system. In one embodiment, the wire element is a color including, but not limited to, blue, white, black, orange, and yellow, or any combination thereof. In one embodiment, the shaft comprises an annular ring. In one embodiment, the wire element further comprises at least one heating element. In one embodiment, the shaft is a telescoping shaft.

In one embodiment, the present invention contemplates a shaft-oriented blade ophthalmic knife having a handle connected to a shaft and the shaft connected to first and second blades. In one embodiment, the first and second blades extend axially from the shaft. In one embodiment, a shaft overhang is positioned between the first and second blades and a lateral edge of the shaft. The overhang is positioned to limit the depth of a cut made by the blade. In one embodiment, the shaft further comprises a gripping arrangement. In one embodiment, the gripping arrangement includes, but is not limited to, a tweezers or forceps element. In one embodiment, the gripping arrangement comprises a sleeve extending over the shaft, where the handle comprises a sleeve actuator switch. In one embodiment, the shaft further comprises a slidable punch capable of detaching tissue from the shaft. In one embodiment, the ophthalmic knife further comprises at least one lumen extending longitudinally within the handle and shaft. In one embodiment, the lumen comprises an outlet in the shaft. In one embodiment, the lumen comprises an inlet in the handle. In one embodiment, the lumen comprises a viscoelastic fluid. In one embodiment, the lumen comprises an aspiration fluid. In one embodiment, the handle is curved. In one embodiment, the device further comprises a fiber optic visualization system. In one embodiment, the shaft is a color including, but not limited to, blue, white, black, orange, and yellow, or any combination thereof. In one embodiment, the shaft comprises an annular ring. In one embodiment, the first and second blades further comprise at least one heating element. In one embodiment, the shaft is a telescoping shaft.

In one embodiment, the present invention contemplates a V-blade ophthalmic knife having a handle connected to a shaft having a first blade, and the shaft connected to a platform, where the first blade extends from the platform such that the first blade and the platform are connected at an angle. In one embodiment, the platform further comprises a forward blade tip. In one embodiment, the forward blade tip is a retractable blade tip. In one embodiment, the forward blade tip is a wedge blade tip. In one embodiment, the blade tip comprises a right triangle. In one embodiment, the right triangle follows the Pythagorean theorem formula ( ^a2 + ^b2 = ^c2 ), where both sides of the tip have lengths a and b, and the length of the hypotenuse is c. In one embodiment, the platform comprises a slope. In one embodiment, the distal end of the platform slopes upward from the perforating blade towards a parallel blade. In one embodiment, the distal end of the platform slopes upward from the perforating blade towards a parallel blade positioned above the level of the TM. In one embodiment, the platform has a bevel of increasing depth extending from the forward blade tip to the rear end. In one embodiment, the platform has a bevel of increasing depth extending from the forward blade tip to the rear end. In one embodiment, the platform has an annular cutting edge. In one embodiment, the shaft further comprises a gripping structure. In one embodiment, the gripping structure includes, but is not limited to, a tweezers or forceps element. In one embodiment, the gripping structure comprises a sleeve extending over the shaft, where the handle comprises a sleeve actuator switch. In one embodiment, the shaft further comprises a slidable punch capable of detaching tissue from the shaft. In one embodiment, the ophthalmic knife further comprises at least one lumen extending longitudinally within said handle and shaft. In one embodiment, the lumen comprises an outlet in said shaft. In one embodiment, the lumen comprises an inlet in said handle. In one embodiment, the lumen comprises a viscoelastic fluid. In one embodiment, the lumen comprises an aspirating fluid. In one embodiment, the handle is curved. In one embodiment, the device further comprises a fiber optic visualization system. In one embodiment, the shaft is a color including, but not limited to, blue, white, black, orange, and yellow, or any combination thereof. In one embodiment, the shaft comprises an annular ring. In one embodiment, the first and second blades further comprise at least one heating element. In one embodiment, the shaft is a telescoping shaft.

In one embodiment, the present invention contemplates a method for using an ophthalmic knife, the method comprising: a) providing an ophthalmic knife selected from the group consisting of a dual platform/dual blade ophthalmic knife, a quad blade ophthalmic knife, an ultrasonic ophthalmic knife, a pincer ophthalmic knife, a grip ophthalmic knife, a lancet ophthalmic knife, an axial blade ophthalmic knife, and a V-blade ophthalmic knife; b) advancing the ophthalmic knife through an incision to a tissue target site; and c) severing a strip of tissue from the target site. In one embodiment, the knife is integrated into an endoscope. In one embodiment, the method further comprises visualizing the cut with a fiber optic visualization system. In one embodiment, the tissue target site is located within a patient's body. In one embodiment, the method further comprises removing the strip of tissue from the tissue target site. In one embodiment, the method further comprises treating the patient for glaucoma. In one embodiment, the treatment comprises draining aqueous humor from the subject's eye. In one embodiment, the advancing further comprises: i) inserting the knife into the anterior chamber of the eye; and ii) positioning the knife adjacent to or within the trabecular meshwork of the eye. In one embodiment, the incision is in an anatomical location selected from the group consisting of an eyeball, skin, a mucosa, an organ, and a tumor.

According to some embodiments, disclosed is a dual blade ophthalmic knife having a handle, a shaft connected to the handle, and a platform connected to the shaft, where the platform has a first blade, a second blade, a forward blade tip, and an extension member, where the extension member is configured in a gripping configuration.

The ophthalmic knife may further have the gripping arrangement being tweezers or forceps. The gripping arrangement may have a spring biased to close the gripping arrangement. The forward blade tip may be a retractable blade tip. The first and second blades may be attached to a first and second lateral side of the platform, respectively. The platform may have a slope of increasing depth extending from the forward blade tip to the rear end. The platform may further have a first annular cutting edge. The width of the platform may be between 0.2 and 0.3 mm. The shaft may be a telescoping shaft. The ophthalmic knife may further have a movable sleeve configured to slidably move along the shaft. The sleeve may be configured to overcome the bias of the gripping arrangement by engaging at least a portion of the gripping arrangement as the sleeve moves in a direction along the shaft. The handle may have an actuation member coupled to the sleeve, the actuation member configured to move the sleeve. At least a portion of the gripping configuration may have a sharpened (sharp) surface configured to cut tissue.

According to some embodiments, disclosed is a method of dissecting trabecular meshwork tissue to form an opening in the trabecular meshwork tissue of an eye having a Schlemm's canal, an anterior chamber, and a trabecular meshwork. The method may include providing a dual blade ophthalmic knife having a handle, a shaft connected to the handle, and a platform connected to the shaft, where the platform has a first blade, a second blade, a forward blade tip, and an extension member, the extension member configured in a gripping configuration. The method may further include inserting the platform into the anterior chamber, the platform including a forward tip, advancing the platform forward tip first through the trabecular meshwork into Schlemm's canal, advancing the platform forward tip first through Schlemm's canal such that the trabecular meshwork tissue is contacted and cut by the first and second blades, and gripping the cut trabecular meshwork tissue in the gripping configuration.

The method may include the gripping structure being tweezers or forceps. The method may include the gripping structure being spring biased to close the gripping structure. The method may further include the platform of the device having a bottom surface that is transversely concave, where the platform is configured such that a posterior wall of Schlemm's canal is apposed to the bottom surface when the platform is advanced into Schlemm's canal. The method may include the handle of the device having an actuation member, where application of a force to the actuation member causes the gripping structure to close. The method may include the handle of the device having an actuation member, where application of a force to the actuation member causes the gripping structure to open.

(definition)
To facilitate understanding of the present invention, certain terms are defined below. Terms defined herein have the meanings as commonly understood by those skilled in the art in the areas relevant to the present invention. Terms such as "a", "an" and "the" are not intended to refer to only a single entity, but include general classes for which specific instances may be used for illustration. Terms herein are used to describe specific embodiments of the present invention, but their usage does not limit the present invention, except as outlined in the claims. 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 subjects are adults, adolescents, infants, and fetuses.

The subject matter disclosed herein should not be limited except in the spirit of the disclosure. Also, in interpreting this disclosure, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms "comprise" and "having" should be interpreted to refer to elements, components, or steps in a non-exclusive manner, indicating that the referenced element, component, or step may be present, utilized, or combined with other elements, components, or steps not expressly referenced.

"Prevention" or "prevent" includes (1) inhibiting the onset of a disease in a subject or patient who may be at risk and/or predisposed to the disease, but who has not yet experienced or displayed some or all of the pathology or symptoms of the disease, and/or (2) delaying the onset of a disease pathology or symptoms in a subject or patient who may be at risk and/or predisposed to the disease, but who has not yet experienced or displayed some or all of the pathology or symptoms of the disease.

As used herein, the term "therapeutically effective amount" or "pharmacologically effective amount" means an amount that, when administered to a subject or patient for treating a disease, is sufficient to effect treatment for the disease or ameliorate one or more symptoms of the disease or condition (e.g., ameliorate pain).

As used herein, the terms "treat" and "treatment" are not limited to cases where a subject (e.g., a patient) is cured and the disease is eradicated. Rather, the present invention also contemplates treatments that merely reduce, ameliorate (to some extent) symptoms, and/or slow the progression of a disease. The present invention is not intended to be limited to instances where a disease or affliction is cured. It is sufficient that symptoms are alleviated.

As used herein, "goniotomy" refers to a surgical procedure primarily used to treat congenital or other types of glaucoma.

As used herein, "trabecular meshwork" refers to the region of eye tissue located around the base of the cornea, near the ciliary body (between the scleral promontory and Schwalbe's line), which is responsible for draining aqueous humor from the eye through the anterior chamber (the chamber at the front of the eye covered by the cornea). The tissue is spongy and lined by trabecular cells, which allow the fluid to drain into a set of canals called Schlemm's canals and ultimately into the blood system.

As used herein, "Schlemm's canal" refers to the circular channel in the eye that collects aqueous humor from the anterior chamber and delivers it into the bloodstream via the collecting tract and the anterior ciliary veins.

As used herein, "ocular disease" refers to various conditions of the eye, including, but not limited to, glaucoma-optic neuropathy, glaucoma suspected-ocular hypertension, primary open-angle glaucoma, primary angle-closure glaucoma, primary open-angle glaucoma, normal or low tension glaucoma, pseudoexfoliation glaucoma, pigment scattering glaucoma, angle-closure glaucoma (acute, subacute, chronic), neovascular or inflammatory glaucoma, ocular hypertension, and other types of glaucoma associated with dysregulation of intraocular pressure.

As used herein, "low intraocular pressure" refers to a reduction in intraocular pressure. The statistical definition of low intraocular pressure is intraocular pressure (IOP) less than 6.5 mmHg, which is more than three standard deviations above the mean IOP. The clinical definition of low intraocular pressure is an IOP low enough to result in pathology (vision loss). Vision loss from low IOP may be caused by corneal edema, astigmatism, cystoid macular edema, maculopathy, or other conditions. Low intraocular pressure maculopathy is characterized by low IOP associated with fundus abnormalities including choroidal folds, optic nerve head edema in acute settings, and vascular tortuosity.

As used herein, "Schwalbe's line" refers to an anatomical line found on the inner surface of the cornea of the eye, marking the outer limit of the corneal endothelial 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 stroma, also called the stroma, and the endothelial layer of the cornea.

As used herein, "scleral promontory" refers to a ring-shaped structure of collagen in the human eye that protrudes 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 glaucoma (OAG) and closed-angle glaucoma (CAG) may be treated with muscarinic receptor agonists (e.g., pilocarpine) that cause rapid myopathy and contraction of the ciliary muscle, which pulls on the scleral promontory, stretching and separating the trabecular meshwork. This opens the fluid pathway and facilitates drainage of aqueous humor into Schlemm's canal, ultimately reducing intraocular pressure.

As used herein, "Trabectome®" refers to a minimally invasive glaucoma surgical instrument for the surgical management of adult, adolescent, and infantile glaucoma. Unlike trabeculectomy, surgery with Trabectome® does not require creating an external filtering bleb or leaving a permanent hole in the eye. Instead, the Trabectome® electrosurgical handpiece opens access to the eye's natural drainage system. The procedure is performed through small incisions similar to cataract surgery, and patients can go home the same day.

The accompanying drawings, which are incorporated in and form a part of this specification, illustrate several embodiments of the present invention and, together with the description, serve to explain the principles of the invention. These drawings are only for the purpose of illustrating preferred embodiments of the invention and are not to be construed as limiting the invention.

1 shows an angled side view of one embodiment of the device along with an enlarged detailed view of the working end of the device having a beveled platform. 1 shows an angled side view of one embodiment of the device with an enlarged detailed view of the working end of the device having the beveled platform 5. The shaded side shows a dimensional view of the beveled platform. The attachment of the instrument shaft 3 and the angles of the first and second blade attachments to the beveled platform 5 are shown. 1 shows a front view of one embodiment of the device along with an enlarged detailed view of the working end of the device having a beveled platform 5. Shown are examples of different attachment angles of the handle 1 to the beveled platform 5 at 0, 15, and 30 degrees clockwise relative to the Z and X axes. Also shown is that the thickness of the platform increases as it extends from the insertion tip 6 towards the rear surface 7 of the platform and from the first side (right) to the second side (left). 4A, B, and C present an exemplary embodiment of a dual platform/dual blade ophthalmic knife. Figure 4A shows a bidirectional configuration 35 with two platforms configured at a 180° angle. 4A, B, and C present an exemplary embodiment of a dual platform/dual blade ophthalmic knife. Figure 4B shows a side-by-side configuration of two platforms. 4A, B, and C present an exemplary embodiment of a dual platform/dual blade ophthalmic knife. Fig. 4C shows an offset configuration of the first and second platforms. An exemplary embodiment of a quad-blade ophthalmic knife is presented, having two platform blades (10 and 11) and two shaft blades (30 and 31). In one embodiment, two upper (shaft) blades positioned above a lower (platform) blade, the upper and lower blades can move up and down to cut the TM between the upper and lower blades (like scissors on either side of a bevel). In one embodiment, the upper blade may move by activating a mechanism, such as squeezing a handle (like MST forceps). 1 shows an embodiment of an ultrasonic ophthalmic knife. An exemplary embodiment of a pincer ophthalmic knife is presented, which has a lower platform with at least two blades and a hinged upper platform with a complementary surface to the lower platform. In one embodiment, the first platform is guided into a tube while the second platform is inside the handle, instrument shaft, or barrel. In one embodiment, the first platform is advanced into the TM, and the second platform is then pushed down towards the first platform to capture the TM between the first and second platforms. In one embodiment, the platforms further have blades or recesses on both the first and second platforms. In one embodiment, the platforms have curved surfaces. In one embodiment, the platforms have complementary surfaces. In one embodiment, the complementary surfaces meet at an articulating surface. In one embodiment, the articulating surface is an edge of the blade. In one embodiment, the platforms join together and cut off a strip of TM in one 8 mm strip. An exemplary embodiment of a grip style ophthalmic knife is presented having a shaft connected to a pair of serrated jaws (e.g., alligator clips). An exemplary embodiment of a lancet ophthalmic knife having a wire element connected to a shaft is presented. An exemplary embodiment of an axial ophthalmic knife having at least two blades connected to a shaft is presented. An exemplary embodiment of a V-blade ophthalmic knife is presented. An exemplary embodiment of an ophthalmic knife having a platform with a through hole is presented. An exemplary embodiment of an ophthalmic knife having at least one internal lumen is presented. An exemplary embodiment of an ophthalmic knife having a platform lacking a bevel (or bevel angle) is presented. An exemplary embodiment of an ophthalmic knife is presented having a platform attached to two blades, where the blades extend from a rear end to a distal forward blade tip. 1 shows a front view of a device according to an embodiment of the present disclosure. 1 shows a front view of a device according to an embodiment of the present disclosure. 1 shows a perspective view of a device in an open position according to an embodiment of the present disclosure. 32B shows a perspective view of the device of FIG. 32A in a closed position according to an embodiment of the present disclosure. FIG. 1 shows a perspective view of a device in a sheathed position according to an embodiment of the present disclosure. FIG. 33B shows a perspective view of the device of FIG. 33A in an unsheathed position according to an embodiment of the present disclosure. FIG. 1 shows a perspective view of a device in a sheathed position according to an embodiment of the present disclosure. FIG. 34B shows a perspective view of the device of FIG. 34A in an unsheathed position according to an embodiment of the present disclosure. 1 illustrates a perspective view of a device having an actuation handle according to an embodiment of the present disclosure. 1 shows a perspective view of a device having a sleeve for aspirating an eye according to an embodiment of the present disclosure. 1 shows a perspective partial view of a device according to an embodiment of the present disclosure.

The present invention relates to an ophthalmic knife and method of use thereof for treating various conditions, including ophthalmic diseases such as glaucoma, using minimally invasive surgical techniques. The ophthalmic knife can be used to cut tissue within the eye, for example, the trabecular meshwork (TM). The present invention also relates to surgical medical interventions. For example, the present invention relates to a microsurgical device and method of use thereof for treating various conditions, including, but not limited to, ophthalmic diseases such as glaucoma, using minimally invasive surgical techniques.

I. Conventional Treatment of Eye Diseases A. Glaucoma Glaucoma is believed to be one of the leading causes of blindness worldwide (1). It has been reported that a modifiable disease risk factor is intraocular pressure (IOP). Conventional treatment has focused on lowering IOP either pharmacologically with antihypertensive drugs or surgically by the use of laser or incision procedures. The main areas of obstruction to aqueous humor outflow, with subsequent dysregulation of IOP, are believed to be located in the canalicular trabecular meshwork (TM) and distal outflow structures (2-4). Performing goniotomy or trabeculectomy in adults with glaucoma has not been associated with great success in lowering IOP (5, 6). In contrast, these procedures have been reported to be more successful in congenital glaucoma, where the membrane overlying the TM is believed to be the major contributor to the impedance of aqueous humor outflow (7). More recently, attempts have been made to use the novel intraocular trabeculectomy procedure to remove TM in adult patients with mixed results (8-10).

One reason for the poor long-term results with this approach in adults may be related to incomplete removal of the TM and subsequent membrane formation over the remaining TM leaflets with subsequent IOP elevation (11). It is unclear how the more complete removal of TM tissue compares to procedures that simply cut the TM, such as MVR blade goniotomy, or procedures that cauterize the TM with tissue removal, such as Trabectome® (Neomedix, Tustin, California, USA). The dual blade device is specifically designed to fit the drainage angle anatomy of the human eye. Without being limiting to the invention, the device is meant to perform an intraocular trabeculectomy by engaging the TM and cutting the target tissue, while minimizing damage to the leaflets left in place and adjacent tissue. The device was designed and manufactured at the University of Colorado Eye Center (U.S. Provisional Patent Application No. 61/637611). (12) Tissue effects from the novel device will be compared to those from goniotomy using a microvitreoretinal (MVR) blade (BD, Franklin Lakes, New Jersey, USA) and cauterization of the TM with the Trabectome® device. Human eye perfusion studies were also completed to evaluate the IOP-lowering efficacy of each approach.

In recent years, there has been an increasing trend towards innovation in minimally invasive glaucoma surgery (MIGS). The risks and imperfections of protected filtration surgery and canal shunt procedures have driven this paradigm shift, despite the proven long-term efficacy of these open procedures. The drawbacks of traditional open procedures include unpredictable IOP lowering results, long-term visual recovery, long-term risk of infection and vision loss, frequency of follow-up visits, and long-term disability rates (13). Procedures such as endoscopic cyclophotocoagulation, intraocular trabeculectomy with Trabectomy®, and canaloplasty with iScience illuminated catheters (iScience, Menlo Park, California, USA) have all been introduced to address the limitations of full-thickness surgery, particularly to eliminate the presence of a filtering bleb. However, the major drawbacks of all of these procedures are the required additional equipment costs and the sometimes steep learning curve. In particular, the additional equipment costs present a significant hurdle for healthcare providers, hospitals, and surgery centers that may require several procedures to recoup the initial investment. Healthcare providers and patients may also face opposition from insurance companies regarding coverage of new procedures that lack long-term efficacy data. The additional equipment requirements also limit patient access to these procedures in underserved areas of the world.

B. Goniotomy Goniotomy is commonly referred to as a surgical procedure primarily used to treat congenital glaucoma. It can be caused by the inhibition of some of the development of structures in the anterior (front) segment of the eye. These structures include the iris and ciliary body, which produce the aqueous humor necessary to maintain the integrity of the eye. These structures do not develop normally in the eyes of patients with isolated congenital glaucoma. Instead, they overlap and block the trabecular meshwork, which is the primary drainage system for aqueous humor. This blockage causes the trabecular meshwork itself to become thicker and the drainage holes in the meshwork to become narrower. These changes can result in excess fluid in the eye, causing pressure that can damage the internal structures of the eye and cause glaucoma.

Generally, congenital glaucoma is caused by a reduction or even complete blockage of the outflow of intraocular fluid. Eye syndromes and disorders that predispose children to congenital glaucoma include the following: Rieger's anomaly, Peter's anomaly, Axenfeld syndrome, and Axenfeld-Rieger syndrome. Systemic disorders that affect the eye in a manner that may lead to glaucoma include Marfan syndrome, rubella (German measles), and nematoses, including neurofibromatosis and Sturge-Weber syndrome. Because these disorders affect the entire body as well as the eyes, the child's pediatrician or family physician will help diagnose and treat these conditions.

One purpose of goniotomy is to remove the obstruction to the outflow of aqueous humor from the eye, which in turn reduces intraocular pressure (IOP). Although it is not necessary to understand the mechanism of an invention, it is believed that lowering the IOP helps stabilize the enlargement of the cornea and the fullness and stretching of the eye that often occurs in congenital glaucoma. However, the size of the eye may not return to normal. Most importantly, as the outflow of aqueous humor improves, damage to the optic nerve is halted or reversed. The patient's vision may improve following surgery.

Before the surgeon begins the procedure, the patient may be administered a miotic, a drug that constricts the pupil. The partial closure improves the surgeon's view and access to the trabecular meshwork, but it may also protect the eye's lens from trauma during surgery. Other drugs may be administered to reduce intraocular pressure. The goniotomy procedure may be performed without the use of miotics. In one embodiment, the present invention may be used in a dilated (non-miotic) pupil setting, as the devices described in the prior art can.

Once the necessary medications have been given and the patient is anesthetized, the surgeon may use forceps or sutures to stabilize the eye in the correct position. The patient's head may be turned away from the surgeon so that the internal structures of the eye can be more easily viewed. Then, with either a knife needle or a goniotomy knife, the surgeon punctures the cornea while looking inside the eye through a microscope or loupes. An assistant may use a syringe to introduce fluid into the anterior chamber of the eye via a viscoelastic tube as the surgeon performs the goniotomy.

A goniolens may then be placed on the eye. As the eye is turned by the assistant, the surgeon sweeps the knife blade or needle through 90-120 degrees of the eye's arc, making an incision in the anterior trabecular meshwork, avoiding the posterior trabecular meshwork to reduce the risk of damage to the iris and lens. Endoscopic visualization may be used to guide the cut. In one embodiment, the device of the present invention may be placed at the end of an endoscope, eliminating the need for a goniolens during treatment. Once the knife and tube are removed, saline may be introduced through the hole to maintain the integrity of the eye, and the hole is closed with sutures. The surgeon then applies antibiotics and corticosteroids to the eye to prevent infection and reduce inflammation. The head may then be turned away from the incision site so that blood cannot accumulate. A second eye may be operated on at the same time. If the procedure needs to be repeated, another area of the eye may be treated.

An earlier device is described in Sorensen et al., "Tubular Cutter Device and Methods For Cutting and Removing Strips of Tissue from the Body of a Patient," U.S. Pat. No. 7,959,641, issued June 14, 2011, (14). See also International Publication WO/2004/110501 (15) and relevant portions of U.S. Patent Publication No. 2007/0276420 (16)). This reference discloses a device for cutting strips of tissue about 50-200 μm wide from the trabecular meshwork. The device has first and second cutting edges formed at the distal end of the cutting tube. The tip can be blunt and in some applications is configured and used to facilitate insertion of the device into its intended location, i.e., Schlemm's canal. Additionally, one or more bends or curves may be optionally formed to facilitate its use. The tip of the device may be advanced through the trabecular meshwork and into Schlemm's canal, thereby cutting a strip of trabecular meshwork with the cutting edge, thereby creating an opening for draining aqueous humor. This reference teaches a cutting blade with a dual cutting surface and a tip for placement into Schlemm's canal to remove trabecular meshwork at any bend/curvature, but does not specifically mention the use of a blade width of 0.3 mm.

Another device is described by Huculak, "Small Gauge Mechanical Tissue Cutter/Aspirator Probe for Glaucoma Surgery," U.S. Patent Publication No. 2009/0287233 (17). This reference discloses the use of a small gauge mechanical tissue cutter/aspirator probe to remove trabecular meshwork. The probe is guided into Schlemm's canal and can be moved in a forward motion to follow the curvature of the trabecular meshwork. This motion delivers the trabecular meshwork into the cutting aperture of the cutter, thereby cutting and removing the trabecular meshwork blocking the outflow of aqueous humor. Due to the size of Schlemm's canal, it is preferred that the distal end of the outer cannula be approximately 0.25-0.36 mm in diameter. The cannula can be tapered to about 0.25-0.36 mm at its distal end (Schlemm's canal is about 0.3 mm). Additionally, the leading edge can be curved to enhance the ability to pierce the trabecular meshwork. This reference teaches the use of small gauge cutters with a diameter of about 0.25-0.36 mm with sharp or blunt leading edges to pierce the trabecular meshwork and entering Schlemm's canal with the cutting opening to cut the trabecular meshwork, but does not teach a dual sharp edge cutting blade per se.

Another device is described in "Minimally Invasive Glaucoma Surgical Instrument and Method" by Baerveldt et al., U.S. Patent Publication No. 2011/0077626 (18) (see also U.S. Patent Nos. 7,785,321 (19) and 6,979,328 (20), and selected portions of U.S. Patent Publication Nos. 2006/0106370 (21) and 2002/0111608 (22)). This reference discloses the use of a cutting probe to cut and remove the trabecular meshwork. The probe has a tip that is about 25 gauge (about 0.5 mm). The tip further has a footplate that acts as a guide into Schlemm's canal. The sharpened end of the footplate is used to perforate the trabecular meshwork. The trabecular meshwork is cut using a rotatable blade or cut in a guillotine fashion. This reference discloses the use of a cutting probe with a tip of about 25 gauge (about 0.5 mm) that includes a footplate to perforate the trabecular meshwork and target Schlemm's canal, but does not itself mention the use of a dual sharp edge cutting blade sized to manipulate Schlemm's canal (0.3 mm). Another device is described in Huculak, "Small Gauge Mechanical Tissue Cutter/Aspirator Probe for Glaucoma Surgery," International Publication WO/2009/140185 (23) (see also selected portions of EP 2303203 (24)). This reference discloses the use of a small gauge mechanical tissue cutter/aspirator probe to remove the trabecular meshwork. The probe is composed of an outer cannula and an inner cannula. The distal end of the inner cannula is configured to cut tissue as it enters the port 310. The inner cannula is moved up and down to cut the tissue. The outer cannula includes a retractable pick with a sharp end for piercing the trabecular meshwork. Due to the size of Schlemm's canal, the distal end of the outer cannula is preferably about 0.25-0.36 mm in diameter. The cannula can be tapered so that its distal end is about 0.25-0.36 mm (Schlemm's canal is about 0.3 mm). This reference discloses the use of a probe between 0.25 and 0.36 mm in size to pierce the trabecular meshwork and to be placed into Schlemm's canal, but does not mention the use of a curvatured, dual sharp edge cutting blade to manipulate Schlemm's canal.

Another device is described in Bergheim, O. B. and Gharib, M., "Apparatus and Method for Treating Glaucoma," WIPO Patent WO/2001/078631, filed March 8, 2001, and application PCT/US2001/007398, published October 25, 2001 (25). This reference discloses the use of a cutting member positioned at the distal end of the canal, including a knife, a sharpened guide member, and a sharpened distal end of the canal. The cutting member is configured to create an opening in the trabecular meshwork for placement of a drainage line into Schlemm's canal. The knife includes a micro-knife ranging in size from 20 (0.88 mm) to 40 gauge, preferably 30 (0.3 mm) gauge. This reference discloses the use of a 20-40 gauge sized cutting element to cut the trabecular meshwork and deliver a drainage line to Schlemm's canal, but does not mention the use of a curvatured, dual sharp edge cutting blade to manipulate Schlemm's canal.

Another device is described in Skjaerpe, Finn, "Microsurgical Instrument," U.S. Pat. No. 4,501,274 (26) (see also selected portions of EP 0 073 803 (27) issued Feb. 26, 1985). This reference discloses a microsurgical probe having a cutting member including two knife blades that project in different directions from the probe, each having at least one sharp cutting edge. The cutting member has a dual cutting knife, where the two cutting edges are angularly spaced apart to create a V-shaped injection canal that is adapted to the topographical features of the eye at Schlemm's canal and trabecular meshwork. The diameter of the probe is about 0.25 mm, and the knife width is 0.3-0.5 mm. The knife blade also includes a cutting edge on both sides so that the probe can be pulled in both directions through Schlemm's canal. This reference discloses a dual knife having at least one sharp cutting edge for cutting the trabecular meshwork and the inner wall of Schlemm's canal, but does not itself mention a curvature for manipulating Schlemm's canal.

Another device is described by Conston et al., "Ophthalmic Microsurgical System," U.S. Patent Publication No. 2006/0149194 (28) (see also selected portions of International Publication WO/2003/045290 (29), European Patent No. 1455698 (30), and Korean Patent No. 1020040058309 (31)). This reference discloses a microsurgical system having an outer microcannula sheath that includes an inner member sized to fit Schlemm's canal, which has a diameter of about 50-200 microns. The inner member has an outer diameter in the range of 50-240 microns to fit within an outer cannula, which has an inner diameter of 50-250 microns. The outer microcannula and the inner member are each capable of conforming to the curvature of Schlemm's canal, and the inner member optionally includes a cutting tool at its distal end having a diamond or sapphire tip or blade or similar element. While this reference discloses a micro-sized probe for cutting the trabecular meshwork and targeting Schlemm's canal, it does not itself mention the use of a dual sharp-edged cutting blade for piercing the trabecular meshwork and targeting Schlemm's canal.

Another device is described in "Ophthalmic Microsurgical Instruments" by Conston et al., U.S. Patent Publication No. 2007/0073275 (32) (see also selected portions of International Publication No. WO/2004/093761 (33) and European Patent No. 1615604 (34)). This reference discloses a microsurgical instrument that can be inserted directly into Schlemm's canal to allow for controlled treatment or removal of adjacent tissue such as TM. The instrument has an outer sheath microcannula and an inner member, and the distal end of the instrument can be curved to approximate the curvature of Schlemm's canal. The instrument includes a cutting means for removing the target tissue. The microcannula is sized to accommodate Schlemm's canal (diameter approximately 200 microns), which has an outer diameter ranging from approximately 100 to 350 microns. The distal tip of the inner member can be beveled or sharpened to provide a cutting action. While this reference discloses a micro-sized probe for cutting the trabecular meshwork and targeting Schlemm's canal, it does not itself mention the use of a dual sharp edge cutting blade to pierce the trabecular meshwork and target Schlemm's canal.

Another device is described by Huculak, "Pulsed Electric Field Probe for Glaucoma Surgery," U.S. Patent Publication No. 2011/0230877 (35). This reference discloses the use of a small gauge pulsed electric field probe to remove trabecular meshwork. The distal end of the probe contains a pick adapted to fit into Schlemm's canal so that the pulsed electric field can be used to dissociate and remove the trabecular meshwork. The pick has a sharp end so that the trabecular meshwork can be pierced and the pick can be placed into Schlemm's canal. The pick is retractable. The probe has a diameter that is between 0.25 and 0.36 mm. This reference discloses the use of a probe between 0.25 and 0.36 mm in size to pierce the trabecular meshwork and place into Schlemm's canal, but does not mention the use of a curvatured, dual sharp edge cutting blade to manipulate Schlemm's canal.

Another device is described in Pantcheva, M. B. and Kahook, M. Y. (2010), "Ab Interno Trabeculectomy," Middle East Afr. J. Ophthalmol. 17(4), pp. 287-289(10). This reference is a review of the Trabectome® device used in this general field.

Another device known in the art that has been used for intraocular trabeculectomy is known as the "gonio scraper" as described by Jacobi et al. (36). This device consists of a handle and a curette tip, which is used to remove TM by scraping the curette through Schlemm's canal. The curette tip is in line with the handle and does not match the exit angle and geometry of the adjacent structures. After promising preclinical trials, a nonrandomized clinical trial of 25 eyes was completed (37). Preoperative IOP was 34.7 ± 7.1 mmHg with 2.2 + 0.56 medications, with a mean follow-up of 32 months. Based on the achievement criterion of a postoperative IOP of 19 mmHg or less with one decompressor, 15 eyes (60%) were successful. Nevertheless, complications including localized Descemet's membrane peeling and/or hyphema were caused in some patients. Histological analysis of preserved human eyes treated with curettage demonstrated successful removal of TM tissue but with damage to the septum and endothelium of the outer and posterior walls of Schlemm's canal (36). In the data presented herein, similar damage to the adjacent sclera was observed with the use of MVR blades, but notably not with the use of one embodiment of a dual blade device as contemplated by the present invention.

In the past few years, there have been reports of both success and failure with the Trabectome® device (8-11, 38). In a recent retrospective study of Trabectome® for extraocular trabeculectomy, Jea et al. found a low success rate in eyes treated with Trabectome® at 2 years (8). Of 115 eyes treated with Trabectome®, only 22.4% were successful, with failure defined as an IOP >21 mmHg or a decrease in IOP of <20%. It is thought that after initial patency of the canal with TM removal, residual leaflets may occlude Schlemm's canal and/or more distal collectors, leading to failure of the intervention. The mechanism of failure after Trabectome® treatment would be overcome by the dual blade device, as more complete removal of TM tissue would be achieved without residual leaflets.

The geometry of the modified dual blade device was designed to minimize the impact on adjacent tissues such as Descemet's membrane by utilizing a specific angle between the handle and the distal blade as well as by using a specific angle between the cutting blade and the adjacent cutting tip. Kahook M. WO2013/163034(39) (hereby incorporated by reference). Several practical advantages of the dual blade device used in intraocular trabeculectomy have been reported. First, the dual blade device is reusable and can be added to a standard cataract surgery tray. Second, the lack of moving parts or the need for combined irrigation or a separate power source allows for inexpensive manufacturing and rapid acquisition of surgical expertise. This will allow for easy and economical access to new technology, especially in underserved locations around the world. In comparison, the conventional Trabectome® device requires a significant initial investment for an irrigation/aspiration unit and generator in addition to the cost of one-time use items such as handpieces and tubing. The simple design and material requirements of the dual blade device embodiment will be more economical. Finally, in contrast to other techniques for TM removal, the dual blade device design embodiment conforms to Schlemm's canal anatomy, minimizes damage to adjacent tissue, and provides excellent control over the removed tissue. In conclusion, the conventional dual blade device may perform intraocular trabeculectomy with or without concomitant cataract extraction.

II. Ophthalmic Knife The following detailed description and the drawings to which it refers are provided only for the purpose of describing and illustrating certain preferred embodiments or examples of the present invention, and no attempt is made to exhaustively describe all possible embodiments or examples of the present invention. Therefore, the following detailed description and the accompanying drawings should not be construed in any manner as limiting the scope of the patents recited in this patent application and any patents issued therefrom.

In one embodiment, the present invention contemplates an ophthalmic knife for cutting ocular tissue (e.g., trabecular meshwork (TM)). In particular, the knife may have a device tip that enters Schlemm's canal via its size (i.e., width between about 0.3 and .2 mm, for example) and a configuration in which the entering blade tip curves upward to provide a bevel-like action for cutting tissue (e.g., trabecular meshwork tissue).

Specific advantages of some embodiments described herein over other conventional devices include, but are not limited to, the following:
1. There are no mechanical moving parts.
2. There is no cauterization or burning of tissue.
3. The multi-blade configuration allows the TM to be cut in a precise manner and placed on the side of the device leaving very little TM behind (conventional devices leave significant residual TM lobes that subsequently become scars).
4. Entry into Schlemm's Canal is achieved using a blade tip. Other similar devices use a non-blade tread to enter Schlemm's Canal.
5. The dimensions of these devices allow for complete ablation and fit precisely into Schlemm's canal.
6. The tip of the blade may be angled upwards into multiple side blades, creating a surface that presents the TM to the blade and subsequently allows for a more precise cut.
7. The distal end of the device is a right triangle according to ^a2 + ^b2 = ^c2 .
8. The distal end is angled upward from the perforating blade to a parallel blade positioned above the level of the TM.
9. The beveled surface lifts the TM above its normal location on the inner wall of Schlemm's canal by lifting the TM away from Schlemm's canal as the device is advanced.
10. As the TM is lifted and the device advanced, it is brought into contact with the parallel blades, resulting in a clean cut through the tissue.
11. Stretching the tissue away from its natural position on the inner wall of Schlemm's canal is a critical step in success.
12. The piercing tip blade is not continuous with the blade at the top of the bevel (i.e. there is no continuous sharp section from the tip to the blade cutting the TM). The bevel area generally does not have a cutting edge.
13. In one embodiment, the device has a flat bottom such that when the device is placed flat on the heel, most of the bottom of the device does not touch the outer wall of Schlemm's Canal (the curve of Schlemm's Canal results in this, so the bottom of the footplate is cupped by Schlemm's Canal). This means that there is less contact and friction with the footplate of the present invention when advanced.
14. All cutting of tissue (except for the initial puncture with the blade tip) is done away from Schlemm's canal (upward toward the anterior chamber).

A. Ophthalmic Knife Platform In some embodiments, the present invention contemplates an ophthalmic knife having a platform. In some embodiments, the platform includes a beveled surface, thereby forming a bevel or wedge shape 38. In some embodiments, the platform is attached to a lateral blade, preferably attached to a lateral side of the platform, see FIG. 1.

In one embodiment, the first lateral blade 10 and the second lateral blade 11 are aligned perpendicular to the bottom of the beveled platform 5. In one embodiment, the invention relates to a device 12 having a handle 1 and a beveled platform 5, where the platform 5 is set at a specific angle and orientation relative to the handle 1. In one embodiment, the invention relates to a device 12 having a handle 1 and a beveled platform 5, where the platform 5 is free to rotate in at least two dimensions. In one embodiment, the handle 1 and the beveled platform 5 are operably mounted at an angle ranging between 90 and 120 degrees in the Y-Z axis. In one embodiment, the handle 1 and the beveled platform 5 are operably mounted at an angle ranging between 90 and 180 degrees in the X-Z axis. In one embodiment, the platform 5 is free to rotate in the X-Y dimension relative to the handle 1. In one embodiment, the platform 5 remains at a fixed angle in the X-Y, X-Z, and Y-Z dimensions relative to the handle 1. In one embodiment, the platform 5 is free to rotate in the positive Z dimension relative to the handle 1. In one embodiment, the beveled platform 5 has a first end/beveled platform tip/insertion blade tip 6 and a second end/back side 7 of the beveled platform, where the second end/back side 7 of the beveled platform is between 2 and 30 times thicker than the first end/beveled platform tip/insertion blade tip 6. In one embodiment, the dimensions of the beveled platform 5 are given by the formula ^A2 + ^B2 = ^C2 , where A is the length of the beveled platform 5 from the insertion blade tip 6 to the back side 7 of the beveled platform, B is the height of the beveled platform 5, and C is the length of the bevel. In one embodiment, the height of the beveled platform 5 does not exceed 0.5 millimeters. In one embodiment, the length of the beveled platform 5 from the insertion blade tip 6 to the back side 7 of the beveled platform does not exceed 1.0 millimeters. In one embodiment, the first end/beveled platform tip/insertion blade tip 6 comprises a fine surgical lancet. In one embodiment, the first end/beveled platform tip/insertion blade tip 6 comprises an angle between 20 and 90 degrees. In one embodiment, the beveled platform 5 increases in thickness in the direction of the Y axis from the fine blade tip to the second end/back surface 7 of the beveled platform. In one embodiment, the first end/beveled platform tip/insertion blade tip 6 comprises a sharp tip with a fine edge of surgical sharpness. In one embodiment, the first end/beveled platform tip/insertion blade tip 6 comprises a lancet. In one embodiment, the beveled platform 5 further comprises a first blade 10 and a second blade 11. In one embodiment, the first blade 10 is attached to a first side 8 of the second end/back surface 7 of the beveled platform. In one embodiment, the first blade 10 and beveled platform 5 are operably mounted at an angle in the range of between 90 and 180 degrees in the YZ axis. In one embodiment, the angle is preferably between 90 and 120 degrees in the YZ axis. In one embodiment, the second blade 11 and beveled platform 5 are operably mounted at an angle in the range of between 90 and 120 degrees in the YZ axis. In one embodiment, the first blade 10 and handle 1 are operably positioned at an angle in the range of between 90 and 120 degrees in the YZ axis. In one embodiment, the second blade 11 and handle 1 are operably positioned at an angle in the range of between 90 and 120 degrees in the YZ axis. In one embodiment, the second blade 11 is mounted to the second side 9 of the second end/rear side 7 of the beveled platform. See FIG. 2. In one embodiment, the front blade tip is a retractable blade tip.

In one embodiment, the beveled platform 5 increases in thickness in the X-axis direction from the second side 9 to the first side 8. FIG. 3. In one embodiment, the beveled platform 5 increases in thickness in the X-axis direction from the second side 9 to the first side 8, and the beveled platform 5 increases in thickness in the Y-axis direction from the fine blade tip at the first end 6 to the second end/back side 7 of the beveled platform.

In one embodiment, the beveled platform 5 increases in thickness in the direction of the X-axis from the first side 8 to the second side 9. In one embodiment, the beveled platform 5 increases in thickness in the direction of the X-axis from the first side 8 to the second side 9, and the beveled platform 5 increases in thickness in the direction of the Y-axis from the fine blade tip of the first end 6 to the second end/back surface 7 of the beveled platform. In one embodiment, the first blade 10 and the second blade 11 extend above the top surface of the second end/back surface 7 of the beveled platform. In one embodiment, the first blade 10 and the second blade 11 are positioned at an angle between about 100 and 140 degrees relative to the top surface of the second end/back surface 7 of the beveled platform. In one embodiment, the beveled platform 5 is about 0.3 millimeters wide. In one embodiment, the beveled platform 5 is about 0.2 millimeters wide. In a preferred embodiment, the beveled platform 5 is approximately 0.25 millimeters wide. In one embodiment, the beveled platform 5 is approximately 1.0 millimeters long. In one embodiment, the beveled platform 5 is approximately 0.4 millimeters high. In one embodiment, the highest points on the beveled platform 5 are the first and second blades. The device 12 may be provided as a pre-sterilized, single-use disposable probe or tip that is attachable to a standard surgical handpiece. In one embodiment, the device further comprises a fiber optic visualization system 24. In one embodiment, the shaft 3 further comprises a gripping arrangement 26. In one embodiment, the gripping arrangement 26 is selected from the group consisting of a tweezers element and a forceps element. In one embodiment, the gripping arrangement 26 comprises a sleeve 27 extending over the shaft, where the handle comprises a sleeve actuator switch.

B. Dual Platform/Dual Blade Ophthalmic Knife In one embodiment, the present invention contemplates a dual platform/dual blade ophthalmic knife having a handle 1 connected to a shaft 3, the shaft connected to a first platform and a second platform, the first platform having a first and second blade and a first forward blade, and the second platform having a third blade 14 and a fourth blade 15 and a second forward blade tip. In one embodiment, as shown in FIG. 4A, the device has two opposing platforms, each platform having at least two lateral blades, each having a blade tip. In another embodiment, as shown in FIG. 4B, the device has two substantially parallel platforms, each platform having at least two lateral blades, each having a blade tip. In one embodiment, the first and second forward blade tips are retractable blade tips. In another embodiment, the device has at least two offset platforms. In another embodiment, the device has at least two offset platforms, each platform having at least two lateral blades, each having a blade tip.

C. Quad Blade Ophthalmic Knife In one embodiment, the present invention contemplates a quad blade ophthalmic knife having a handle 1 connected to a shaft 3, said shaft connected to a platform having four cutting blades and forward blade tips, see FIG. 5. In one embodiment, two upper (shaft) blades (30 and 31) are positioned above a lower (platform) blade (10 and 11), and the upper and lower blades can move up and down to cut the TM between the upper and lower blades (like scissors on either side of a bevel). In one embodiment, the upper blade may be moved by activating a mechanism 32, such as squeezing the handle 1 (like MST forceps).

D. Ultrasonic Ophthalmic Knife In one embodiment, the present invention contemplates an ultrasonic ophthalmic knife having a handle 1, a shaft 3, a forward blade tip, and a platform having an ultrasonic emitter 25. In one embodiment, the ultrasonic ophthalmic knife is shown in FIG.

E. Pincer Ophthalmic Knife In one embodiment, the present invention contemplates a pincer ophthalmic knife having a handle 1 connected to a shaft 3, and the shaft connected to a lower platform and an upper platform. In one embodiment, the platform is curved. In one embodiment, the first platform is guided into the canal while the second platform is inside the handle 1, instrument shaft 3, or barrel 16. In one embodiment, the first platform is advanced into the TM, and then the second platform is then pushed down towards the first platform to capture the TM between the first and second platforms. In one embodiment, the platforms further have blades or recesses on both the first and second platforms. In one embodiment, the platforms have complementary surfaces. In one embodiment, the complementary surfaces articulate with an articulating surface. In one embodiment, the articulating surface is an edge of the blade. In one embodiment, the platforms are joined together to cut a strip of TM into one 8mm strip. In one embodiment, the device is shown in FIG.

F. GRIP-ON OPHTHALMIC KNIFE In one embodiment, the present invention contemplates a grip-on ophthalmic knife having a handle 1 connected to a shaft 3, the shaft including a lateral alligator clip 17, and a platform connected to the shaft 3, the platform 5 having a first lateral blade 10a and a front blade tip 6. In one embodiment, the alligator clip 17 has first and second alligator clip blades 18, 19. In one embodiment, the alligator clip 17 has a clip with a spring that closes the articulating jaws. In one embodiment, the alligator clip has a clip with a spring that closes the serrated jaws. An example of an alligator clip (17) is shown in FIG. 8. In one embodiment, only the top jaw of the alligator clip moves up and down. In one embodiment, the bottom jaw of the alligator clip stays in Schlemm's canal. In one embodiment, the elliptical movement of the top jaw of the alligator clip draws into the TM, cuts it, and then pushes it back out.

G. Lancet Ophthalmic Knife In one embodiment, the present embodiment contemplates a lancet ophthalmic knife having a handle 1 connected to a shaft 3 and the shaft connected to a wire element 20. In one embodiment, the shape of the wire element may be retracted or collapsed into the shaft 3. In one embodiment, the wire element is rigid. In one embodiment, the shape of the wire element may vary from having a tip to something as simple as a square wire. In one embodiment, the wire element 20 has at least one sharp edge. In one embodiment, the wire element 20 has at least one blunt edge. In one embodiment, the wire element 20 has a square shape, as shown in FIG. 9. In one embodiment, the wire element 20 may be triangular, square, rectangular, or elliptical. In one embodiment, the wire element 20 is pushed into the TM. In doing so, the wire element 20 stretches and slightly opens up Schlemm's canal. The wire element 20 is then advanced through the canal, cutting the TM such that the sharpened wire leaves a long trailing strip of TM.

H. Axial Blade Ophthalmic Knife In one embodiment, the present invention contemplates an axial blade ophthalmic knife having a handle 1 connected to a shaft 3, and said shaft connected to first and second blades. In one embodiment, said axial blade has an axial extension 21 with at least one distal blade. In one embodiment, said distal blade is affixed to said axial extension, where the distance between said blade and the edge of the distal tip of said axial extension has an overhang 36. In one embodiment, said overhang 36 limits the depth of the cut. In one embodiment, as shown in FIG. 10, said device has two parallel blades (10 and 11) attached to said axial extension 21, where the space between said blade and the edge of said axial extension 21 has an overhang 36.

I. V-Blade Ophthalmic Knife In one embodiment, the present invention contemplates a V-blade ophthalmic knife having a handle 1 connected to a shaft 3 having a first blade, and the shaft connected to a platform, where the first blade overhangs the platform such that the first blade and the platform are connected at an angle. In one embodiment, the angle of attachment and overhang of the shaft 3 to the platform creates a surface for shearing tissue. In one embodiment, the knife further has a window through which cut tissue can pass. Figure 11 shows a side view of one embodiment of this device, where the dashed line shows one embodiment of an internal through hole 23.

J. Ophthalmic Devices As shown in FIG. 16, the device 112 may have a platform 105 with an extension member 117. The platform 105 has a leading edge 106 and a trailing edge 107. The platform 105 may have similar features as the platform 5, but with the addition of the extension member 117. The device 112 may include a slidable sleeve 118 disposed over the shaft 104 and configured to slide back and forth over at least a portion of the exterior shaft surface 103 of the shaft 104 and the platform 105. The sleeve 118 may be sized and shaped to provide a fluid flow path 119 between the shaft surface 103 and the interior sleeve surface 121. The fluid flow path 119 may be configured to deliver, for example, a topical balanced salt solution, medication, viscoelastic (e.g., OVD), or therapeutic agent to the site, or to flush out blood reflux.

The sleeve 118 may have a sleeve end 128 from which an engagement portion 123 may extend. The engagement portion may be sized and shaped to engage the extension member 117 when the sleeve 118 is slidably disposed in a closed position toward the extension member 117. The engagement portion 123 has a surface 124 configured to grasp tissue cut or excised by the platform 105. For example, the sleeve 118 may be positioned in a generally open position such that a gap 125 exists between the surface 124 and the extension member 117. The gap 125 may have a maximum width when the sleeve 118 is maximally retracted, where the width of the gap 125 decreases as the sleeve 118 moves to a position where it is fully engaged against the extension member, in which case the gap 125 may have little or no width.

The gap 125 may provide an outlet for fluid dispersed from the fluid flow passage 119. Fluid may also be dispersed from the end 129 of the fluid flow passage 119. The fluid flow passage 119 may be configured to aspirate fluid back from the site. For example, fluid from the site (e.g., blood, excess irrigation fluid) may flow into the gap 125 and/or end 129, through the fluid flow passage 119, and out the handle end of the device 112. As another example, the fluid flow passage 119 may be configured to deliver fluid from the gap 125 and/or end 129, and return fluid may return up the device 112 to the shaft 104 through an internal lumen (not shown). In aspects of the present disclosure, the lumen may be disposed on the outside of the shaft 104 and within the fluid flow passage 119.

Surface 124 may be provided as a gripping surface configured to engage tissue, thereby allowing sleeve 118 to grip tissue between surface 124 and extension member 117. The tissue may then be removed by removing device 112 from the site to dispose of the tissue, or by using another device (e.g., phacoemulsification). In aspects of the present disclosure, surface 124 may be provided as a pressing surface configured to press tissue down onto cutting surface 127 of extension member 117. Thus, platform 105 may have multiple cutting portions.

The sleeve 118 may be coupled to an engagement member of a handle, such as a squeeze handle 150, as shown in FIG. 21, for example. Thus, when an actuation member (e.g., trigger) 152 of the handle 150 is squeezed, the sleeve 118 may slidably move toward the platform 105 to grasp and/or cut tissue between the surface 124 and the extension member 117. Similarly, when the squeezing force on the handle 150 is removed (e.g., releasing the trigger 152), the sleeve 118 may slidably move away from the platform 105 to release the tissue. In aspects of the present disclosure, the biasing force on the sleeve 118 may be reversed. For example, when the handle 150 is open (e.g., not squeezed), the sleeve 118 may be positioned such that the surface 124 engages the extension member 117 (e.g., the sleeve 118 is in a closed position), and when the handle 150 is squeezed, the sleeve 118 may slidably move away from the platform 105 to open the gap 125 so that tissue or an object may be engaged.

As shown in FIG. 17, the device 212 may have a platform 205 with an extension member 217. The platform 205 has a front tip 206 and a rear end 207. The platform 205 may have similar features to the platform 5, but with the addition of the extension member 217. The device 212 may include a slidable sleeve 218 disposed over the shaft 204 and configured to slide back and forth over the exterior shaft surface 203 of the shaft 204. The sleeve 218 may be sized and shaped to provide a fluid flow path 219 between the shaft surface 203 and the interior sleeve surface 221. The fluid flow path 219 may be configured, for example, to deliver a local balanced salt solution, medication, viscoelastic (e.g., OVD) or therapeutic agent to the site, or to flush blood reflux.

The extension member 217 may be flexibly coupled to the rear end 207 of the platform 205. The extension member 217 may be an integral part of the platform 205 that extends outward at an angled position. For example, the extension member 217 may be biased to an open position, as shown in FIG. 17, and configured to be pushed toward a closed position when the sleeve 218 is slidably moved toward the platform 205, thus exerting a force on the extension member 217 that is directed inward toward the rear end 207. In this manner, the extension member 217 may be configured as a grasper (e.g., tweezers) to grasp tissue. Similarly, the sleeve 218 may be slidably moved on the shaft 204 away from the platform 205, and the biasing force on the extension member 217 may move the extension member (e.g., open or spring back) to release the tissue.

The extension member 217 may be sized and shaped to essentially mirror the opposing portion of the trailing end 207 of the platform 205. In aspects of the present disclosure, the device 212 may have multiple extension members 217 spaced around the shaft 204, where the multiple extension members 217 may be configured to move toward the shaft 204 or the platform 205, respectively, when the slidable sleeve 218 is moved toward the platform 205. In this manner, each extension member 217 may be configured to grasp a different portion of the tissue or object.

The trailing end 207 may have a surface 207a and the extension member 217 may have a surface 217a. Some or all of the surfaces 207a and/or 217a may be sharpened cutting surfaces. For example, one of the surfaces 207a, 217a may be unsharpened and the other of the surfaces 207a, 217a may be sharpened, or both surfaces 207a, 217a may be sharpened, thus providing a cutting function to the trailing end 207 of the platform 205. As another example, both surfaces 207a, 217a may be unsharpened, thus providing a gripping function to the trailing end 207 of the platform 205.

As shown in FIGS. 18A and 18B, the device 312 may have a shaft 304 and a platform 305 having a front tip 306 and a rear end 307. The shaft 304 may be divided into two shaft sections 304a and 304b. The shaft sections 304a, 304b may be biased away from each other in an un-triggered or default position such that a gap 325 is disposed between the shaft sections 304a and 304b. This un-triggered position may occur when the movable sleeve 318 is pulled away from the platform 305, as shown in FIG. 18A. When the slidable sleeve 318 is moved (e.g., activated, triggered) toward the platform 305, the sleeve 218 may exert a force on the shaft sections 304a, 304b such that the shaft sections 304a, 304b move toward each other, as shown in FIG. 18B. As another example, the shaft portions 304a, 304b may move toward one another to perform a gripping function, such that the split shaft 304 can grip tissue or an object. As another example, the shaft portions 304a, 304b may move toward one another to perform a cutting function, such that the split shaft 304 can cut tissue or an object. The platform 305 may otherwise have a similar structure and/or function as the platform 5.

18A and 18B, the platform 305 and/or sleeve 318 may be sized and shaped such that the sleeve 318 is not configured to slide over the entire platform 305. Here, in the fully closed position of the device 312 shown in FIG. 18B, the sleeve 318 extends over only a portion of the platform 305 or does not extend over any of the platforms 305 at all. In some aspects of the disclosure, the sleeve 318 may be sized and shaped to fit completely over the platform in a sheathed or closed position as shown in FIG. 19A, and to slidably move away from the platform 305 to an unsheathed or open position to expose the platform 305 as shown in FIG. 19B.

As shown in FIGS. 20A and 20B, the device 412 may have a shaft 404 and a platform 405 having a front tip 406 and a rear end 407. The platform 405 may have similar features to any of the platforms 5, 105, 205, 305. A sleeve 418 is configured to slideably move over the shaft 404. The sleeve 418 may include an extension member 417 configured to push tissue down onto the blades 410, 411 of the platform 405 to cut or shear the tissue. The extension member 417 may be sized and shaped to fit between the blades 410 and 411 when the sleeve 418 is moved to the closed position shown in FIG. 20A to improve cutting of the tissue. For example, the extension member 417 may be short fingers configured to push tissue down onto the blades 410, 411 as the device 412 is moved through the tissue site. As another example, the extension member 417 may be sized and shaped (e.g., long fingers) to grasp tissue or an object between the extension member 417 and the front of the platform 405.

The device 112, 212, 312, 412 may be configured to have a shaft 104, 204, 304, 404 and sleeve 118, 218, 318, 418 of any desired shape. For example, the shaft 104, 204, 304, 404 may be cylindrical (e.g., circular cross-section) and the sleeve 118, 218, 318, 418 may be similarly shaped to match. In aspects of the present disclosure, the shaft 104, 204, 304, 404 and sleeve 118, 218, 318, 418 may be oval, oval, etc. The sleeve 118, 218, 318, 418 may be sized and shaped to conform to the shaft 104, 204, 304, 404. For example, the sleeve 118, 218, 318, 418 may be shaped (e.g., form-fitting) to fit snugly around the shaft 104, 204, 304, 404. The form-fitting sleeve 118, 218, 318, 418 may not have a fluid flow path between the shaft 104, 204, 304, 404 and the sleeve 118, 218, 318, 418. In another example, the sleeve 118, 218, 318, 418 may be shaped differently than the shaft 104, 204, 304, 404, e.g., a circular shaft 104, 204, 304, 404 and an elliptical sleeve 118, 218, 318, 418. The sleeve 118, 218, 318, 418 may be formed from one or more materials (e.g., metals) that are rigid or substantially rigid.

As shown in FIG. 22, the device 512 with sleeve 518 may be used to aspirate biological material (e.g., blood, tissue) from the eye, where irrigation fluid may flow through the sleeve 518 and exit through one or more ports 538. The aspirating may be done by suction pulling the biological material back out of the hollow portion (e.g., lumen) of the shaft 504. The sleeve 518 may be any desired material (e.g., silicone).

23, the shaft 504 may have an engagement member 539 configured to stop the sleeve 518 from sliding further up the shaft 504. For example, the engagement member 539 may protrude outwardly from the shaft 504, where the engagement member 539 may be a pin, disk, ridge, or the like. The engagement member 539 may be retractable, such that the engagement member 539 prevents the sleeve 518 from sliding further up the shaft 504 when in an engaged position, and the engagement member 539 may allow the sleeve 518 to slide further up the shaft 504 when in a retracted position.

In one or more embodiments, any of the devices 112, 212, 312, 412 may be disposed within the sleeve 518. For example, the sleeve 118, 218, 318, 418 may be a rigid metal cannula, and the sleeve 518 may be a flexible silicone sleeve disposed over the rigid metal sleeve 118, 218, 318, 418, and may have an opening at the end of the sleeve 518 from which the platform 5, 105, 205, 305 may extend. As an example, the sleeve 518 may provide a fluid circuit configured to provide fluid flow from the port 538, where the fluid flows into the space between the sleeve 518 and the sleeve 118, 218, 318, 418, and the fluid and/or tissue flows back through the device 112, 212, 312, 412.

III. Materials of Construction Although it is not intended that embodiments of the present invention be limited to a particular material of construction, it is believed that preferred materials include titanium, stainless steel, polyetheretherketone (PEEK), ceramics, rigid plastics, shape memory alloys such as Nitinol, and shape memory polymers. In some embodiments, the platform is made of silicone or another polymer or hydrogel.

In some embodiments, the knives contemplated herein may be made of a material that is transparent to optical coherence tomography (OCT) wavelengths (e.g., typically 800-1600 nm). In one embodiment, the OCT transparent material includes, but is not limited to, glycol modified poly(ethylene terephthalate), polyvinyl chloride, poly(methyl methacrylate), or polyphenylsulfone. Although it is not necessary to understand the mechanism of this invention, it is believed that these materials allow for the performance of intraoperative OCT during intraocular surgery without any visual interference from the ophthalmic knife.

In one embodiment, the device is made from a metal alloy material as described in Furst, J. G. et al., Metal Alloys for Medical Devices, U.S. Patent No. 7,648,591 (40), and Richter, K., Amorphous Metal Alloy Medical Devices, U.S. Patent No. 7,955,387 (41), all of which are incorporated herein by reference. In one embodiment, the device is made from a metal alloy material as described in Reimink, M. S. and Ogle, M. F., Amorphous Metal Alloy Medical Devices, U.S. Patent No. 7,955,387 (41), all of which are incorporated herein by reference. (42); Langer, R. S. and Lendlein, A., "Shape Memory Polymers," U.S. Pat. No. 6,388,043 (43); Langer, R. S. and Lendlein, A., "Shape Memory Polymers," U.S. Pat. No. 6,720,402 (44); Tong, T. H. "Shape Memory Styrene Copolymers," U.S. Pat. No. 6,759,481 (45); Stalker, K. C. B. et al., "Variable Stiffness Medical Devices," U.S. Pat. No. 7,632,303 (46); Anthamatten, M. L. and Li, J., "Shape Memory Polymers," U.S. Pat. No. 7,935,131 (47); Berger, E. J. The device is made of a shape memory polymer material as described in "Methods of Forming a Part Using Shape Memory Polymers" by Friedrichs et al., U.S. Patent No. 8,038,923 (48). In some embodiments, the device is rigid at room temperature but more flexible at body temperature. In some embodiments, portions of the device are rigid at room temperature but more flexible at body temperature. In some embodiments, portions of the device are made of different materials. In some embodiments, portions of the device are made of materials of different stiffness. In one embodiment, the shaft is flexible. In some embodiments, the shaft is made of a material with a lower density.

Although it is not intended that embodiments of the present invention be limited to any particular material of construction, preferred materials are believed to include titanium, stainless steel, polyetheretherketone (PEEK), shape memory alloys, and shape memory polymers. In some embodiments, the devices of the present invention are rigid at room temperature but more flexible at body temperature. In some embodiments, portions of the devices of the present invention are rigid at room temperature but more flexible at body temperature. In some embodiments, portions of the devices are made of different materials. In some embodiments, portions of the devices are made of materials of varying stiffness. In one embodiment, the instrument shaft 3 is flexible. In some embodiments, the shaft is made of a material with a lower density.

C. Methods of Using a Multi-Blade Ophthalmic Knife In one embodiment, the present invention contemplates a method for using an ophthalmic knife comprising a) providing an ophthalmic knife selected from the group consisting of a dual platform/dual blade ophthalmic knife, a quad blade ophthalmic knife, an ultrasonic ophthalmic knife, a pincer ophthalmic knife, a grip style ophthalmic knife, a lancet ophthalmic knife, an axial blade ophthalmic knife, and a V-blade ophthalmic knife, b) advancing the ophthalmic knife through an incision to a tissue target site, and c) severing a strip of tissue from the target site.

(Detailed differences between devices)
Although it is not intended that embodiments of the present invention be limited to any particular method, medical target, or device validation, it is believed that the device may be optimally designed to remove trabecular meshwork in the eye, unroof small blood vessels (such as veins, arteries, lymphatic vessels, or other blood vessels with lumens), and create holes or openings in the tympanic membrane of the ear. Although it is not intended that embodiments of the present invention be limited to any particular mechanism, it is believed that creating openings in the tympanic membrane of the ear may aid in the treatment of ear disorders.

It is not intended that embodiments of the present invention be limited to any particular endoscope, and it is believed that the device may be optimally designed for an endoscope in an ophthalmic endoscopy system. One such system is commercially known as "Endo Optics."

Thus, certain compositions and configurations of multiple blade cutting systems have been disclosed. However, it will be apparent to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein.

All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein should be construed as an admission that the present invention is not entitled to antedate such publications by virtue of prior invention. Further, the dates of publications provided may be different from the actual publication dates, which may require independent confirmation.

(experiment)
Approval for preclinical studies (49) was obtained from the Colorado Multi-Institutional Review Board for the use of human material prior to initiation of the study and adhered to the tenets of the Declaration of Helsinki. Informed consent was obtained from donors or relatives for use in research by the eye bank from which the human eyes were obtained.

"Example I"
(Histological analysis)
Six corneal limbal specimens were obtained from the Rocky Mountain Lions Eye Bank (Aurora, Colorado, USA) and the San Diego Eye Bank (San Diego, California, USA). Tissue samples were removed from storage media, mounted on a platform with the TM side facing up, and secured in place using tissue pins. A total of two samples were used for each of the three treatment methods studied. An MVR blade was used to incise the central TM under microscopic visualization along the length of the two corneal limbuses. The Trabectome® device was inserted with the footplate at the tip of the device into Schlemm's canal under microscopic visualization. Once in place, a stepping plate was used to slowly advance the tip across the extent of the TM sample, resulting in continuous ablation. A standard power setting of 0.8 W was used during treatment. The dual blade device was used to dissect the TM of two samples. The blade tip was used to dissect the TM in a similar manner to that used for the goniotomy, after which the blade was advanced clockwise along the extent of the TM. At the distal end, the blade tip was angled upward to dissect a complete ribbon of the TM, and this process was repeated counterclockwise to dissect the remaining TM tissue.

All tissue samples were then immediately stored in 4% paraformaldehyde/phosphate buffered saline overnight at 4°C and then cut radially into multiple quadrants. The margins were processed for histology and embedded in paraffin with the cut edge of the tissue facing the front of the block. Tissue sections (6 mm thick) were cut and stained with Mayer's hematoxylin and eosin Y (Richard-Allan Scientific, Kalamazoo, Michigan, USA). Bright-field imaging was performed using a Nikon Eclipse 80i microscope (Nikon, Melville, New York, USA) equipped with a Nikon D5-Fil color camera and a Nikon CFI103/Plan Fluor objective.

"Example II"
(Human eye perfusion)
A total of 12 human eyes from pseudophakic donors with no history of glaucoma were obtained from various eye banks across the country for perfusion studies of each device. The perfusion system used a standard programmable syringe pump (Pump 11 Plus; Harvard Apparatus, Holliston, Massachusetts, USA). Pressure was monitored via an in-line real-time pressure transducer (Research Grade Pressure Transducer, Harvard Apparatus) connected to a single channel chart recorder (Pharmacia REC-481; Pharmacia/Pfizer New York, New York, USA). Polyethylene tubing (PE-160; Warner Instruments, Hamden, Connecticut, USA) with an inner diameter of 1.14 mm was used for all connections.

In each case, the human eye was first prepared by injecting Dulbecco's modified Eagle medium (DMEM; Invitrogen/Life Technologies, Carlsbad, California, USA) through the optic nerve with a 26-gauge (0.45 mm) needle until the globe returned to a spherical shape. An irrigation line (terminating in another 26-gauge needle) was inserted obliquely through the anterior chamber of the eye, passing through the cornea and pupil, terminating with its tip just below the iris. The globe was surrounded by moist gauze, the irrigation pump (filled with DMEM) was set at an initial inflow rate of 7 mL/min, and IOP was allowed to increase until it reached 30 mmHg. The infusion rate was then reduced to 2-5 mL/min to maintain steady-state IOP for at least 60 minutes before TM incision. Preoperative IOP was measured immediately prior to incision in each case. A 1.7 mm stainless steel corneal incision blade (BD) was used to make a clear corneal incision at a triclinic angle near the limbus, and the anterior chamber was filled with sufficient viscoelastic (Healon GV; Abbott Medical Optics, Abbott Park, Illinois, USA) to maintain the anterior chamber and provide adequate visualization during the procedure in each case. Each technique was performed gonioscopically using a standard direct gonioscope with a microscope. The surgical procedure used for each device is described above. Approximately 100-180 degrees of TM were treated in each case. For each device, treatment began 180 degrees away from the corneal wound and extended along the angle in a clockwise direction. The device was then extended counterclockwise from the same starting point. Every effort was made to treat the maximum amount possible with each device.

In the case of the conventional modified dual blade device and the Trabectome®, the instrument was rotated 180 degrees after the first pass to orient the device tip in the treatment direction. IOP was allowed to reach a steady state before measuring post-treatment IOP. Each of the three studied surgical techniques was performed on a total of four eyes.

Two peripheral corneal sections were analyzed for each device. Six micron thick histological sections were taken from various working hours treated with each device and stained with Mayer's hematoxylin and eosin Y (Richard-Allan Scientific). Findings were consistent across all sections from each device tested. Cuts with the MVR blade showed complete dissection through the entire thickness of the TM tissue. However, removal of TM was minimal, with a large leaflet of tissue remaining above Schlemm's canal. The incision penetrated Schlemm's canal deeply, with obvious damage to the adjacent deep sclera in the majority of the sections (Figure 1). The Trabectome® also secured an opening through the entire TM tissue into Schlemm's canal. The device also removed a large portion of the central TM, but still left a significant leaflet of residual tissue. The residual TM showed extensive charring due to thermal damage. Furthermore, tissue debris also occluded the distal collecting tract (Figure 2). Tissue dissected with the dual blade device demonstrated more complete removal of the TM without collateral damage (Figure 3).

Data from the human eye perfusion study are included in Table 1. The extent of TM treatment varied between devices and between eyes from 100 to 180 degrees. All three treatment modalities achieved significant reductions in IOP measured 30 minutes after treatment. Treatment with the dual blade device and Trabectome® resulted in a 40% reduction in mean IOP, respectively, while the MVR blade achieved a 31% reduction. Although the percentage of IOP reduction was greater with the Trabectome® and dual blade devices, there were no statistically significant differences in IOP reduction between the devices (dual blade/MVR P=.13; dual blade/Trabectome® P=.96; Trabectome®/MVR P=.12). There was no correlation between the degree of treated TM and percent IOP change for any device (r2=0.077-0.271).

In this study, an initial preclinical evaluation of an embodiment of the present invention, a dual blade device for the treatment of glaucoma, is presented (49). Histological analysis of human cadaveric eye tissue treated with the dual blade device demonstrated that more complete removal of TM tissue was achieved while avoiding any discernible damage to the surrounding tissue. Treatment with other TM removal methods, such as MVR blade goniotomy and intraocular trabeculectomy with the Trabectome® device, failed to achieve histological results comparable to the novel dual blade device. Although histological data was obtained from the periphery of ex vivo treated corneas, similar findings were noted when treatment was performed using an intraocular approach on perfused eyes. The near absence of TM leaflets with the dual blade device may be beneficial in reducing the possibility of future physical obstruction, and the lack of tissue damage may also reduce inflammatory responses or subsequent fibrosis at the surgical site.

In addition to potentially favorable histological outcomes, the dual blade device provided significant IOP reduction in a perfusion model of the human eye. While all three devices provided similar immediate reductions in IOP following use in the perfusion model, it is unclear how the more complete removal of TM tissue and reduced collateral damage with the dual blade device of the present invention will translate to long-term surgical outcomes when used to treat glaucoma. No correlation was observed between the extent of TM treated and the degree of IOP reduction. It seems plausible that IOP reduction may be more dependent on the number of downstream collecting tracts exposed, rather than the absolute amount of TM removal alone.

In an effort to provide a low-cost MIGS device that can be widely used by ophthalmic surgeons, one embodiment of the present invention contemplates that a novel medical grade stainless steel dual blade device has been designed that can successfully remove the TM without discernible collateral damage. In one embodiment, the device has a unique dual edge blade design that uses precise geometry to allow for more complete removal of the TM tissue (FIGS. 4A and B). Although it is not necessary to understand the mechanism of the invention, it is believed that this procedure is performed from an intraocular approach and is viscoelastic to maintain the anterior chamber. For example, the size and tip of the blade can allow smooth entry into Schlemm's canal, similar to the technique used in traditional goniotomy procedures. Once in place, the tip is advanced through Schlemm's canal and the TM is lifted along a bevel designed to direct the tissue toward a set of blades specifically positioned to dissect and remove the TM. In contrast to the Trabectome® footplate, which is apposed between the outer and inner walls of Schlemm's canal to provide protection during cauterization, the dual blade device traverses the TM and lifts it from the outer wall of Schlemm's canal. Although it is not necessary to understand the mechanism of an invention, it is believed that lifting the TM along the bevel of the device as it advances leads to maximum tissue removal when incised by the superiorly positioned and strategically angled dual blade. Furthermore, it is believed that the angle between the distal cutting edge and the handle is engineered to allow maximum angle treatment with a single incision while avoiding trauma to the cornea superiorly or the scleral promontory inferiorly. The excised TM may then be removed from the eye with forceps or aspirated during the irrigation/aspiration phase when combined with cataract extraction. In addition, the device of the present invention can easily pass through clear corneal incisions as small as 1.2 mm, eliminating the need for additional incisions when combined with phacoemulsification.

"Example III"
(Traditional incision goniotomy)
The procedure begins with an incision of the trabecular meshwork that extends into the sclera with a large segment of the trabecular meshwork. In this procedure (considered the gold standard procedure for "cutting" the trabecular meshwork and traditionally called a "goniotomy"), an MVR blade is used to incise the trabecular meshwork to create an opening into Schlemm's canal. Histological samples were obtained from procedures where an incision was present through the trabecular meshwork and extended into the sclera. Large leaflets of trabecular meshwork were left on either side of the incision. These leaflets leave scars to plug the opening created into Schlemm's canal. This precludes any long-term effect on the goal of the surgery: lowering intraocular pressure.

"Example IV"
Trabectome® Treatment
In this procedure (designed to replace goniotomy and improve it by removing sections of trabecular meshwork), a Trabectome® device was used to engage the trabecular meshwork and cauterization was applied to the trabecular meshwork. The circles indicate areas where small segments of trabecular meshwork were removed, but large leaflets of trabecular meshwork remain on either side of the treatment area, with charred tissue. After Trabectome® treatment, remnants of trabecular meshwork and charred tissue were shown. Tissue debris occludes the collecting passages, the device "burns" the tissue, and burning of the tissue causes inflammation that creates more scarring leading to failure to surgically induce an opening into Schlemm's canal. Additionally, cauterization causes many air bubbles to form during the procedure, making visualization difficult during the actual procedure. These problems do not occur with the device of the present invention, which is a major advantage.

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LIST OF REFERENCE NUMERALS 1 Handle 2 First interface 3 Instrument shaft 4 Second interface 5 Platform 6 Insertion tip 7 Beveled platform second end/rear 8 First side 9 Second side 10 First blade 11 Second blade 12 Device 13 Second platform 14 Third blade 15 Fourth blade 16 Barrel of device 17 Alligator clip 18 First alligator clip blade 19 Second alligator clip blade 20 Wire element 21 Axial extension 22 Internal lumen/collection passage 23 Through hole 24 Optical fiber 25 Ultrasound emitter 26 Gripping configuration 27 Sleeve or cap 28 Sleeve or cap actuator switch 29 Curved platform 30 First upper blade 31 Second upper blade 32 Handle trigger 33 Blade heating element 34 Lancet-shaped/hollow/wire 35 Double-sided/bi-directional device 36 overhang 37 non-beveled platform, angled blade 38 wedge 39 slidable punch

Claims (14)

1. A dual blade ophthalmic knife, comprising:
A handle and
A shaft connected to the handle;
a platform connected to the shaft, a front portion of the platform extending radially outward from the shaft; and a first blade;
A second blade,
a platform having a forward blade tip; and an extension member extending from an aft end of the platform opposite a forward end of the platform and extending radially outward from the shaft, the extension member configured as a gripping arrangement;
1. A dual blade ophthalmic knife having a movable sleeve configured for slidable movement along said shaft, said movable sleeve configured to grasp tissue between said sleeve and said grasping structure. The ophthalmic knife of claim 1, wherein the gripping structure is a pair of tweezers. The ophthalmic knife of claim 1, wherein the gripping structure is a forceps. The ophthalmic knife of claim 1, wherein the gripping arrangement has a spring biased to close the gripping arrangement. The ophthalmic knife of claim 1, wherein the forward blade tip is a retractable blade tip. The ophthalmic knife of claim 1, wherein the first blade and the second blade are attached to a first lateral side and a second lateral side, respectively, of the platform. The ophthalmic knife of claim 1, wherein the platform further has a first cutting edge. The ophthalmic knife of claim 1, wherein the shaft is a telescopic shaft. The ophthalmic knife of claim 1, wherein the sleeve is configured to overcome a biasing force of the gripping arrangement by engaging at least a portion of the gripping arrangement as the sleeve moves in a direction along the shaft. The ophthalmic knife of claim 1, wherein the handle has an actuation member coupled to the sleeve, the actuation member configured to move the sleeve. The ophthalmic knife of claim 1, wherein at least a portion of the gripping arrangement has a sharp surface configured to cut tissue. The ophthalmic knife of claim 1, wherein the platform further has a bottom surface that is concave. The ophthalmic knife of claim 1, wherein the handle has an actuation member configured to cause the gripping arrangement to close. The ophthalmic knife of claim 1, wherein the handle has an actuation member configured to open the gripping arrangement.

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