Ophthalmic knife

Abstract

The present invention relates to an ophthalmic knife that uses minimally invasive surgical techniques to treat various conditions including eye diseases, such as glaucoma. The present invention relates to a multi-blade device for cutting tissue within the eye, such as the trabecular meshwork (TM).

Description

[0001] Cross-application of related applications

[0002] This application is a continuation-in-part of U.S. patent application No. 16 / 015,078, filed on June 21, 2018 (published as U.S. Patent No. 10,653,558 on May 19, 2020), which is a continuation-in-part of U.S. patent application No. 15 / 389,328, filed on December 22, 2016 (published as U.S. Patent No. 10,213,342 on February 26, 2019), which is a non-provisional patent application of and claims the benefit of U.S. Provisional Patent Application No. 62 / 387,351, filed on December 23, 2015, entitled “Ophthalmic knife and methods of use.” Technical Field

[0003] The present invention relates to an ophthalmic knife and methods 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, such as the trabecular meshwork. The present invention also relates to surgical medical interventions. For example, the present invention relates to a microsurgical device and methods of use thereof for treating various medical conditions, including but not limited to ocular diseases, such as glaucoma, using minimally invasive surgical techniques. Background Art

[0004] There are many such medical treatments and surgical operations, in which it is necessary to cut and remove a controlled width tissue strip from the body of a human or animal patient. For example, it may be necessary to form a controlled width incision (for example, an incision is wider than the incision formed by a typical scalpel, cutting blade or needle) in eyes, skin, mucous membrane, tumor, organ or other tissues or humans or animals sometimes. In addition, it may be necessary to remove a strip or a certain amount of tissue from the body of humans or animals sometimes, as a biopsy specimen, for chemical / biological analysis, for retention or archiving of DNA identification purposes etc. In addition, some surgical operations need to remove a tissue strip of known width from the anatomical position in the body of the patient. A kind of surgical operation is an ophthalmic operation for treating glaucoma, in which a tissue strip of known width is removed from the anatomical position in the body of the patient. This ophthalmic operation is sometimes referred to as goniotomy. During a goniotomy procedure, a device is inserted into the anterior chamber of the eye and used to remove a full-thickness strip of tissue from the trabecular meshwork. The device is operable to cut or ablate a strip of tissue approximately 2-10 mm in length or longer and approximately 50-200 μm in width. There remains a need in the art for a simple, inexpensive, and precise instrument for performing procedures to cut the trabecular meshwork (TM) in the eye and effectively remove an intact, full-thickness strip of TM without leaving behind the TM leaflets, as well as for other procedures requiring removal of a strip of tissue from a larger tissue mass. Summary of the Invention

[0005] The present invention relates to an ophthalmic knife and methods 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, such as the trabecular meshwork. The present invention also relates to surgical medical interventions. For example, the present invention relates to a microsurgical device and methods of use thereof for treating various medical conditions, including but not limited to ocular diseases, such as glaucoma, using minimally invasive surgical techniques.

[0006] In one embodiment, the present invention contemplates a dual platform / dual blade ophthalmic knife comprising a handle connected to a shaft, the shaft being connected to a first platform and a second platform, the first platform comprising a first blade and a second blade and a first front blade tip, the second platform comprising a third blade and a fourth blade and a second front blade tip. In one embodiment, the front blade tip is a retractable blade tip. In one embodiment, the first front blade tip and the second front blade tip are retractable blade tips. In one embodiment, the front blade tip is a wedge-shaped blade tip. In one embodiment, the first blade and the second blade are attached (respectively) to the first lateral side and the second lateral side of the first platform. In one embodiment, the third blade and the fourth blade are attached (respectively) to the third lateral side and the fourth lateral side of the second platform. In one embodiment, the first platform and the second platform are constructed at an angle of 180°. In one embodiment, the blade tip comprises a right triangle. In one embodiment, the right triangle follows the Pythagorean theorem formula (a 2 +b 2 =c 2), wherein the sides of the distal end include lengths a and b and the length of the hypotenuse is c. 8. In one embodiment, each of the platforms includes a slope. In one embodiment, the distal end of the platform slopes upward from the piercing blade toward the parallel blade. In one embodiment, the distal end of the platform slopes upward from the piercing blade toward the parallel blade positioned above the TM level. In one embodiment, the first and second platforms are staggered. In one embodiment, the first and second platforms are parallel. In one embodiment, the first platform includes a first slope that increases in depth extending from the first front blade end to the first rear end. In one embodiment, the second platform includes a second slope that increases in depth extending from the second front blade end to the 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 includes 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 includes an annular cutting edge. In one embodiment, the second platform includes an annular cutting edge. In one embodiment, the first and second transverse blades are retractable and attached (respectively) within the first and second platform cavities. In one embodiment, the third and fourth transverse blades are retractable and attached to the third and fourth platform cavities (respectively). In one embodiment, the handle includes a transverse blade actuator switch in operable 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 come together to grasp tissue. In one embodiment, the gripping feature includes but is not limited to a forceps element or a tweezers element. In one embodiment, the parallel dual platforms can be actuated to come together to grasp tissue. In one embodiment, the gripping feature includes a sleeve extending over the shaft, wherein the handle includes a sleeve actuator switch. In one embodiment, the gripping feature is made of a shape memory material that is retractable into the lumen of the device. In one embodiment, the platform further includes a slidable punch that can separate 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 includes an outlet port in the platform. In one embodiment, the outlet port is on the top surface of the platform. In one embodiment, the outlet port is on the bottom surface of the platform. In one embodiment, the lumen comprises an inlet port in the handle. In one embodiment, the lumen comprises a viscoelastic fluid. In one embodiment, the lumen comprises a suction 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 approximately 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 comprises 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 telescopic shaft.

[0007] In one embodiment, the present invention contemplates a four-blade ophthalmic knife comprising a handle connected to a shaft connected to a platform comprising a front blade tip and four cutting blades. In one embodiment, the front blade tip is a retractable blade tip. In one embodiment, the front blade tip is a wedge-shaped blade tip. In one embodiment, the platform comprises a first blade and a second blade, the first blade and the second blade being attached (respectively) to a first lateral side and a second lateral side of the platform. In one embodiment, the blade tip comprises a right triangle. In one embodiment, the right triangle follows the Pythagorean theorem formula (a 2 +b 2 =c 2), wherein the sides of the distal end include lengths a and b, and the length of the hypotenuse is c. In one embodiment, the platform comprises a ramp. In one embodiment, the distal end of the platform slopes upward from the piercing blade toward the parallel blade. In one embodiment, the distal end of the platform slopes upward from the piercing blade toward the parallel blade positioned above the horizontal level of the TM. In one embodiment, the shaft further comprises a third blade and a fourth blade, the third blade and the fourth blade being attached to the first and second lateral sides of the shaft (respectively). In one embodiment, the third blade and the fourth blade are slidably engaged with the shaft. In one embodiment, the handle comprises a compressible material that contacts the third and fourth blades. In one embodiment, the shaft is connected to a second four-blade blade positioned at a 180° angle to the first four-blade blade. In one embodiment, the shaft is connected to the second four-blade blade positioned parallel to the first four-blade blade. In one embodiment, the platform comprises a ramp that increases in depth from the front blade end to the rear end. In one embodiment, the first and second blades are parallel. In one embodiment, the first and second blades are angled. In one embodiment, the platform comprises an annular cutting edge. In one embodiment, the first and second transverse blades are retractable and attached to the first and second platform cavities (respectively). In one embodiment, the handle includes a transverse blade actuator switch in operable communication with the first platform cavity and the second platform cavity. In one embodiment, the platform further includes a gripping feature. In one embodiment, the gripping feature includes, but is not limited to, a forceps element or a tweezers element. In one embodiment, the gripping feature includes a sleeve extending from the shaft, wherein the handle includes a sleeve actuator switch. In one embodiment, the platform further includes a slidable punch that can separate 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 includes an outlet port in the platform. In one embodiment, the outlet port is on the top surface of the platform. In one embodiment, the outlet port is on the bottom surface of the platform. In one embodiment, the lumen includes an inlet port in the handle. In one embodiment, the lumen includes a viscoelastic fluid. In one embodiment, the lumen includes an aspiration 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 approximately 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 includes 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 telescopic shaft.

[0008] In one embodiment, the present invention contemplates an ultrasonic ophthalmic scalpel comprising a handle, a shaft, a front blade tip, and a platform, wherein the platform comprises an ultrasonic transmitter and a pad to protect surrounding tissue from the ultrasonic blade. In one embodiment, when the device is activated, the front blade tip of the ultrasonic transmitter vibrates at a fixed frequency. In one embodiment, the tip is capable of longitudinal and lateral movement. In one embodiment, the ultrasonic transmitter has an adjustable power setting. In one embodiment, the power setting is optimized to minimize the application of heat during use. The ultrasonic scalpel allows for cutting tissue while reducing the need to pre-stretch or tension the tissue. When the device is activated, the blade tip vibrates at a fixed frequency. The tip is capable of longitudinal and lateral movement. The power setting is optimized to minimize the application of heat to the tissue. In one embodiment, the front blade tip is a wedge-shaped blade tip. In one embodiment, the front blade tip is a retractable blade tip. In one embodiment, the blade tip comprises a right triangle. In one embodiment, the right triangle follows the Pythagorean theorem formula (a 2 +b 2 =c 2), wherein the sides of the distal end include lengths a and b, and the length of the hypotenuse is c. In one embodiment, the platform includes a slope. In one embodiment, the distal end of the platform slopes upward from the puncturing blade toward the parallel blade. In one embodiment, the distal end of the platform slopes upward from the puncturing blade toward the parallel blade positioned above the horizontal level of the TM. In one embodiment, the platform further includes a gripping feature. In one embodiment, the gripping feature includes but is not limited to a forceps element or a tweezers element. In one embodiment, the gripping feature includes a sleeve extending from the shaft, wherein the handle includes a sleeve actuator switch. In one embodiment, the platform further includes a slidable punch capable of separating tissue from the ultrasonic scalpel. 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 includes an outlet port in the platform. In one embodiment, the outlet port is on the top surface of the platform. In one embodiment, the outlet port is on the bottom surface of the platform. In one embodiment, the lumen includes an inlet port in the handle. In one embodiment, the lumen includes a viscoelastic fluid. In one embodiment, the lumen includes a suction 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 ultrasound device further comprises a fiber optic visualization system. In one embodiment, the platform has a width of approximately 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 comprises 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 telescopic shaft.

[0009] In one embodiment, the present invention contemplates a forceps-shaped ophthalmic knife comprising a handle connected to a shaft, wherein the shaft is connected to a lower platform and an upper platform. In one embodiment, the lower platform comprises a front blade tip. In one embodiment, the front blade tip is a wedge-shaped blade tip. In one embodiment, the shaft and the upper platform are connected by a hinge. In one embodiment, the lower platform comprises 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 comprises a first slot and a second slot, wherein the first slot and the second slot are positioned above the first blade and the second blade. In one embodiment, the lower platform further comprises a front blade tip. In one embodiment, the blade tip comprises a right triangle. In one embodiment, the right triangle follows the Pythagorean theorem formula (a 2 +b 2 =c 2), wherein the sides of the distal end include lengths a and b and the length of the hypotenuse is c. In one embodiment, the platform includes a slope. In one embodiment, the distal end of the platform is inclined upward from the puncturing blade toward the parallel blade. In one embodiment, the distal end of the platform is inclined upward from the puncturing blade toward the parallel blade positioned above the horizontal height of the TM. In one embodiment, the length of the lower platform is at least 8 mm. In one embodiment, the platform further includes a grasping feature. In one embodiment, the grasping feature includes but is not limited to a forceps element or a tweezers element. In one embodiment, the grasping feature includes a sleeve extending on the shaft, wherein the handle includes a sleeve actuator switch. In one embodiment, the platform further includes a slidable punch capable of separating tissue from the forceps ophthalmic knife. In one embodiment, the forceps ophthalmic knife device further includes at least one lumen extending longitudinally within the handle, shaft, and platform. In one embodiment, the lumen includes an outlet port in the platform. In one embodiment, the outlet port is on the top surface of the platform. In one embodiment, the outlet port is on the bottom surface of the platform. In one embodiment, the lumen includes an inlet port in the handle. In one embodiment, the lumen includes a viscoelastic fluid. In one embodiment, the lumen includes 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 forceps ophthalmic knife device further comprises a fiber optic visualization system. In one embodiment, the width of the platform is approximately 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 comprises 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 telescopic shaft.

[0010] In one embodiment, the present invention contemplates a clamping ophthalmic knife comprising a handle connected to a shaft, the shaft comprising a first transverse alligator clip and a second transverse alligator clip, a platform connected to the shaft, the platform comprising a first transverse blade and a second transverse blade, and a front blade tip. In one embodiment, the front blade tip is a wedge-shaped blade tip. In one embodiment, the front blade tip is a retractable blade tip. In one embodiment, the blade tip comprises a right triangle. In one embodiment, the right triangle follows the Pythagorean theorem formula (a 2 +b 2 =c 2), wherein the sides of the distal end include lengths a and b, and the length of the hypotenuse is c. In one embodiment, the platform includes a slope. In one embodiment, the distal end of the platform slopes upward from the piercing blade toward the parallel blade. In one embodiment, the distal end of the platform slopes upward from the piercing blade toward the parallel blade positioned above the horizontal height of the TM. In one embodiment, a first transverse blade and a second transverse blade are attached to a first and a second transverse side of the platform (respectively). In one embodiment, the first transverse alligator clip includes a first and a second serrated jaw. In one embodiment, the second transverse alligator clip includes a first and a second serrated jaw. In one embodiment, the first and second serrated jaws of the first transverse alligator clip are hinged. In one embodiment, the first and second serrated jaws of the second transverse alligator clip are hinged. In one embodiment, the handle includes a compressible material that contacts the first and second alligator clips. In one embodiment, the platform further includes a gripping feature. In one embodiment, the gripping feature includes but is not limited to a forceps element or a tweezers element. In one embodiment, the gripping feature includes a sleeve extending over the shaft, wherein the handle includes a sleeve actuator switch. In one embodiment, the platform further comprises a slidable punch that can separate 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 port in the platform. In one embodiment, the outlet port is on the top surface of the platform. In one embodiment, the outlet port is on the bottom surface of the platform. In one embodiment, the lumen comprises an inlet port in the handle. In one embodiment, the lumen comprises a viscoelastic fluid. In one embodiment, the lumen comprises a suction 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 width of the platform is approximately 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 comprises 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 telescopic shaft.

[0011] In one embodiment, the present embodiment contemplates a lancet ophthalmic knife comprising a handle connected to a shaft, wherein the shaft is connected to a wire element. In one embodiment, the wire element comprises 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 comprises a first wire end and a second wire end. In one embodiment, the first wire end is connected to the shaft at a first position. In one embodiment, the second wire end is connected to the shaft at a second position. In one embodiment, the shaft further comprises a gripping feature. In one embodiment, the gripping feature includes, but is not limited to, a forceps element or a tweezers element. In one embodiment, the gripping feature includes a sleeve extending over the shaft, wherein the handle includes a sleeve actuator switch. In one embodiment, the shaft further comprises a slidable punch capable of separating tissue from the wire element. In one embodiment, the lancet further comprises at least one lumen extending longitudinally within the handle and shaft. In one embodiment, the lumen includes an outlet port in the shaft. In one embodiment, the lumen includes an inlet port 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 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 includes an annular ring. In one embodiment, the wire element also includes at least one heating element. In one embodiment, the shaft is a telescopic shaft.

[0012] In one embodiment, the present invention contemplates an axial-blade ophthalmic knife comprising a handle connected to a shaft, wherein the shaft is 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 cutting by the blades. In one embodiment, the shaft further comprises a gripping feature. In one embodiment, the gripping feature includes, but is not limited to, a forceps element or a tweezers element. In one embodiment, the gripping feature comprises a sleeve extending over the shaft, wherein the handle includes a sleeve actuator switch. In one embodiment, the shaft further comprises a slidable punch capable of separating 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 includes an outlet port in the shaft. In one embodiment, the lumen includes an inlet port in the 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 shaft is colored, including, but not limited to, blue, white, black, orange, and yellow, or any combination thereof. In one embodiment, the shaft includes 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 telescopic shaft.

[0013] In one embodiment, the present invention contemplates a V-blade ophthalmic knife comprising a handle connected to a shaft comprising a first blade, the shaft being connected to a platform, wherein the first blade is cantilevered from the platform such that the first blade and the platform are connected at an angle. In one embodiment, the platform further comprises a front blade tip. In one embodiment, the front blade tip is a retractable blade tip. In one embodiment, the front blade tip is a wedge-shaped blade tip. In one embodiment, the blade tip comprises a right triangle. In one embodiment, the right triangle follows the Pythagorean theorem formula (a 2 +b 2 =c 2), wherein the sides of the distal end include lengths a and b, and the length of the hypotenuse is c. In one embodiment, the platform includes a slope. In one embodiment, the distal end of the platform slopes upward from the puncturing blade toward the parallel blade. In one embodiment, the distal end of the platform slopes upward from the puncturing blade toward the parallel blade positioned above the horizontal level of the TM. In one embodiment, the platform includes a slope that increases in depth extending from the front blade end to the rear end. In one embodiment, the platform includes a slope that increases in depth extending from the front blade end to the rear end. In one embodiment, the platform includes an annular cutting edge. In one embodiment, the shaft further includes a gripping feature. In one embodiment, the gripping feature includes but is not limited to a forceps element or a tweezers element. In one embodiment, the gripping feature includes a sleeve extending over the shaft, wherein the handle includes a sleeve actuator switch. In one embodiment, the shaft further includes a slidable punch capable of separating tissue from the shaft. In one embodiment, the ophthalmic knife further includes at least one lumen extending longitudinally within the handle and shaft. In one embodiment, the lumen includes an outlet port in the shaft. In one embodiment, the lumen includes an inlet port in the handle. In one embodiment, the lumen includes 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 blade and the second blade further comprise at least one heating element. In one embodiment, the shaft is a telescopic shaft.

[0014] In one embodiment, the present invention contemplates a method of using an ophthalmic knife, comprising: a) providing an ophthalmic knife selected from a dual-platform / dual-blade ophthalmic knife, a quad-blade ophthalmic knife, an ultrasonic ophthalmic knife, a forceps ophthalmic knife, a clamping 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) cutting a tissue strip from the target site. In one embodiment, the knife is integrated into an endoscope. In one embodiment, the method further comprises visualizing the cutting using 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 tissue strip from the tissue target site. In one embodiment, the method further comprises treating glaucoma in the patient. 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 near or within the trabecular meshwork of the eye. In one embodiment, the incision is made in an anatomical location selected from the group consisting of an eyeball, skin, a mucosa, an organ, and a tumor.

[0015] According to some embodiments, a double-blade ophthalmic knife is disclosed, comprising: a handle; a shaft connected to the handle; and a platform connected to the shaft, wherein the platform comprises: a first blade; a second blade; a front blade tip; and an extension member, wherein the extension member is configured as a gripping feature.

[0016] The ophthalmic knife may further include a gripping feature that is a pair of forceps or tweezers. The gripping feature may include a spring that is biased to close the gripping feature. The front blade tip may be a retractable blade tip. The first blade and the second blade may be attached to a first lateral side and a second lateral side of the platform, respectively. The platform may include a ramp that increases in depth from the front blade tip to the rear end. The platform may also include a first annular cutting edge. The platform may have a width between 0.2 and 0.3 mm. The shaft may be a telescopic shaft. The ophthalmic knife may also include a movable sleeve that is configured to slidably move along the shaft. The sleeve may be configured to overcome the biasing force of the gripping feature by engaging at least a portion of the gripping feature when the sleeve is moved in a direction along the shaft. The handle may include an actuating member coupled to the sleeve, the actuating member being configured to cause the sleeve to move. At least a portion of the gripping feature may include a sharpened surface configured to cut tissue.

[0017] According to some embodiments, a method for incising the trabecular meshwork to form an opening in trabecular meshwork tissue of an eye having Schlemm's canal, an anterior chamber, and the trabecular meshwork is disclosed. The method may include providing a double-blade ophthalmic knife comprising: a handle; a shaft connected to the handle; and a platform connected to the shaft, wherein the platform comprises: a first blade; a second blade; an anterior blade tip; and an extension member, wherein the extension member is configured as a grabbing feature. The method may also include inserting the platform into the anterior chamber, the platform comprising an anterior tip; with the anterior tip leading, pushing the platform through the trabecular meshwork and into Schlemm's canal; with the anterior tip leading, pushing the platform through Schlemm's canal such that the trabecular meshwork tissue contacts and is severed by the first and second blades; and grabbing the severed trabecular meshwork tissue with the grabbing feature.

[0018] The method may include wherein the gripping feature is a pair of forceps or tweezers. The method may include wherein the gripping feature includes a spring biased to close the gripping feature. The method may include wherein the platform of the device further includes a laterally concave bottom surface, wherein the platform is configured such that when the platform is pushed into Schlemm's canal, the posterior wall of Schlemm's canal is juxtaposed with the bottom surface. The method may include wherein the handle of the device includes an actuating member, wherein application of a force to the actuating member causes the gripping feature to close. The method may include wherein the handle of the device includes an actuating member, wherein application of a force to the actuating member causes the gripping feature to open.

[0019] definition

[0020] To facilitate understanding of the present invention, a number of terms are defined below. The terms defined herein have the meanings commonly understood by those of ordinary skill in the art to which the present invention relates. Terms such as "a," "an," and "the" are not intended to refer only to a single entity, but rather to general categories of which specific examples may be used for illustration. The terms herein are used to describe specific embodiments of the present invention, but their use does not limit the present invention unless 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 a 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.

[0021] The subject matter of the invention disclosed herein is not limited except in the spirit of the present disclosure. In addition, when interpreting the present disclosure, all terms should be interpreted in the broadest manner consistent with the context. In particular, the terms "comprise" and "comprising" should be interpreted as referring to elements, components or steps in a non-exclusive manner, indicating that the referenced elements, components or steps may exist, be used or be combined with other elements, components or steps that are not explicitly referenced.

[0022] "Preventing" or "preventing" includes: (1) inhibiting the onset of a disease in a subject or patient who may be at risk for and / or susceptible to a disease but who has not yet experienced or developed any or all of the pathology or symptoms of the disease, and / or (2) slowing the onset of a pathology or symptom of a disease in a subject or patient who may be at risk for and / or susceptible to a disease but who has not yet experienced or developed any or all of the pathology or symptoms of the disease.

[0023] As used herein, the term "therapeutically effective amount" or "pharmaceutically effective amount" means an amount that, when administered to a subject or patient for treating a disease, is sufficient to effect such treatment for the disease or to alleviate one or more symptoms of the disease or condition (e.g., relieve pain).

[0024] As used herein, the terms "treated" and "treatment" are not limited to situations where a subject (e.g., patient) is cured and the disease is eradicated. Rather, the present invention also contemplates treatments that merely alleviate symptoms, improve (to a certain extent), and / or delay disease progression. The present invention is not limited to situations where the disease or affliction is cured. Relief of symptoms is sufficient.

[0025] As used herein, "goniotomy" refers to a surgical procedure primarily used to treat congenital glaucoma or other types of glaucoma.

[0026] As used herein, "trabecular meshwork" refers to the area of ​​tissue in the eye located around the base of the cornea, near the ciliary body (between the sclera and Schwarz's lines), that is responsible for draining aqueous humor from the eye via the anterior chamber (the chamber at the front of the eye covered by the cornea). The tissue is spongy and lined by trabecular cells; it allows fluid to flow into a set of tubes called Schlemm's canals and ultimately into the blood system.

[0027] As used herein, "Schlemm's canal" refers to the circular channel in the eye that collects aqueous humor from the anterior chamber and conveys it to the bloodstream via collecting ducts and the anterior ciliary veins.

[0028] As used herein, "ocular disease" refers to various ocular diseases, including but not limited to glaucoma (optic neuropathy, suspected glaucoma), ocular hypertension, primary open-angle glaucoma, primary angle-closure glaucoma, primary open-angle glaucoma, normal or low-tension glaucoma, pseudoexfoliation glaucoma, pigment-dispersive glaucoma, angle-closure glaucoma (acute, subacute, chronic), neovascular or inflammatory glaucoma, high intraocular pressure, and other types of glaucoma associated with impaired regulation of intraocular pressure.

[0029] As used herein, "hypotony" refers to a reduction in intraocular pressure. The statistical definition of hypotony is an intraocular pressure (IOP) below 6.5 mmHg, which is more than 3 standard deviations lower than the mean IOP. The clinical definition of hypotony is an IOP low enough to cause pathology (vision loss). The vision loss caused by low IOP may be caused by corneal edema, astigmatism, cystoid macular edema, maculopathy or other conditions. The feature of low IOP maculopathy is the low intraocular pressure associated with fundus abnormalities, including chorioretinal folds, acute optic nerve head edema and vascular tortuosity.

[0030] As used herein, "Schwalbe's line" refers to an anatomical line found on the inner surface of the cornea of ​​the eye and which delineates the outer limit of the corneal endothelium. Specifically, it represents the termination of Disseminator's membrane.

[0031] As used herein, "Descemet's membrane" refers to the basement membrane located between the corneal substance proper (also called stroma) and the endothelium of the cornea.

[0032] As used herein, "scleral spur" refers to a ring-shaped structure composed of collagen in the human eye, i.e., a protrusion of the sclera into the anterior chamber. The scleral spur is the starting point of the longitudinal fibers of the ciliary muscle and is attached to the front of the trabecular meshwork. Open-angle glaucoma (OAG) and closed-angle glaucoma (CAG) can be treated with muscarinic receptor agonists (e.g., pilocarpine), which cause rapid miosis and contraction of the ciliary muscle, thereby pulling the scleral spur and causing the trabecular meshwork to be stretched and separated. This can open fluid channels, promote drainage of aqueous humor to Schlemm's canal, and ultimately reduce intraocular pressure.

[0033] As used herein, Refers to minimally invasive glaucoma surgical tools used for the surgical treatment of glaucoma in adults, adolescents and infants. Unlike trabeculectomy, the The procedure should not create an external filtering bleb and need not leave a permanent hole in the eye. An electrosurgical handpiece opens access to the eye's natural drainage system. The procedure is performed through a small incision similar to cataract surgery and allows the patient to return home the same day. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the present invention and, together with the description, serve to explain the principles of the present invention. The accompanying drawings are only used to illustrate preferred embodiments of the present invention and are not to be construed as limiting the present invention.

[0035] Figure 1An angled side view of one embodiment of the device is shown, along with an enlarged detailed view of the operative end of the device having a beveled platform.

[0036] Figure 2 An angled side view of one embodiment of the device is shown, along with an enlarged detailed view of the operating end of the device having a bevel platform 5. The shaded area provides an illustration of the dimensions of the bevel platform. The angles of the tool shaft 3 attachment and the first and second blade attachments relative to the bevel platform 5 are shown.

[0037] Figure 3 A front view of one embodiment of the device is shown, along with an enlarged detail of the operating end of the device having a beveled platform 5. Examples of different angles of attachment of the handle 1 to the beveled platform 5 are shown, at 0 degrees, 15 degrees, and 30 degrees clockwise relative to the Z and X axes. Increasing platform thickness is also shown as the platform extends from the insertion tip 6 toward the back of the platform 7, and from the first side (right side) to the second side (left side).

[0038] Figure 4A 、 Figure 4B and Figure 4C An exemplary embodiment of a dual platform / dual blade ophthalmic knife is shown. Figure 4A A bidirectional configuration 35 is depicted with two platforms configured at a 180° angle. Figure 4B The parallel construction of two platforms is described. Figure 4C The staggered configuration of the first and second platforms is depicted.

[0039] Figure 5 An exemplary embodiment of a four-blade ophthalmic knife is shown, comprising two platform blades (10 and 11) and two shaft blades (30 and 31). In one embodiment, two upper (shaft) blades are positioned above a lower (platform) blade, and the upper and lower blades can move up and down to cut the TM between the upper and lower blades (similar to scissors on either side of the bevel). In one embodiment, the tipper blades can be moved by a trigger mechanism, such as squeezing a handle (like MST forceps).

[0040] Figure 6 One embodiment of an ultrasonic ophthalmic knife is depicted.

[0041] Figure 7An exemplary embodiment of a forceps-type ophthalmic knife is shown, which includes a lower platform containing at least two blades and a hinged upper platform having a surface complementary to the lower platform. In one embodiment, the first platform is guided into the tube and the second platform is inside the handle, tool shaft or barrel. In one embodiment, the first platform is pushed into the TM and then the second platform is squeezed toward the first platform to capture the TM between the first and second platforms. In one embodiment, the platform also includes blades or grooves on the first and second platforms. In one embodiment, the platform has a curved surface. In one embodiment, the platform has complementary surfaces. In one embodiment, the complementary surfaces occlude at a surface of an occlusal portion. In one embodiment, the surface of the occlusal portion is the edge of the blade. In one embodiment, the platforms engage with each other and cut the TM strip into an 8 mm strip.

[0042] Figure 8 An exemplary embodiment of a clamping ophthalmic knife is shown that includes a shaft connected to a pair of serrated jaws (eg, alligator clips).

[0043] Figure 9 An exemplary embodiment of a lancet ophthalmic knife comprising a wire element connected to a shaft is shown.

[0044] Figure 10 An exemplary embodiment of an axial ophthalmic knife is shown that includes at least two blades connected to a shaft.

[0045] Figure 11 An exemplary embodiment of a V-blade ophthalmic knife is shown.

[0046] Figure 12 An exemplary embodiment of an ophthalmic knife having a platform including a through hole is shown.

[0047] Figure 13 An exemplary embodiment of an ophthalmic knife comprising at least one internal lumen is shown.

[0048] Figure 14 An exemplary embodiment of an ophthalmic knife comprising a platform without an incline (or ramp) is shown.

[0049] Figure 15 An exemplary embodiment of an ophthalmic knife comprising a platform attached to two blades is shown, wherein the blades extend from a posterior end to a distal anterior blade tip.

[0050] Figure 16 Shown is a front view of an apparatus according to an embodiment of the present disclosure.

[0051] Figure 17Shown is a front view of an apparatus according to an embodiment of the present disclosure.

[0052] Figure 18A A perspective view of a device in an open position is shown according to an embodiment of the present disclosure.

[0053] Figure 18B A perspective view of the device of FIG. 32A is shown in a closed position, in accordance with an embodiment of the present disclosure.

[0054] Figure 19A A perspective view of a device in a cuffed position is shown according to an embodiment of the present disclosure.

[0055] Figure 19B A perspective view of the device of FIG. 33A is shown in an unjacketed position in accordance with an embodiment of the disclosure.

[0056] Figure 20A A perspective view of a device in a cuffed position is shown according to an embodiment of the present disclosure.

[0057] Figure 20B A perspective view of the device of FIG. 34A is shown in an unjacketed position in accordance with an embodiment of the present disclosure.

[0058] Figure 21 A perspective view of a device having an actuation handle according to an embodiment of the present disclosure is shown.

[0059] Figure 22 A perspective view of a device with a sleeve applying suction to an eye is shown in accordance with an embodiment of the present disclosure.

[0060] Figure 23 A perspective partial view of an apparatus according to an embodiment of the present disclosure is shown.

[0061] Reference Signs List

[0062] 1 handle

[0063] 2 First interface

[0064] 3 Tool axis

[0065] 4 Second interface

[0066] 5 Platform

[0067] 6 Insert end

[0068] 7 Second end / back of the inclined platform

[0069] 8 First side

[0070] 9 Second side

[0071] 10 First Blade

[0072] 11 Second Blade

[0073] 12 Devices

[0074] 13 Second Platform

[0075] 14 Third Blade

[0076] 15 The Fourth Blade

[0077] 16. Cylinder of the device

[0078] 17 alligator clips

[0079] 18 First Alligator Clip Blade

[0080] 19 Second alligator clip blade

[0081] 20 Wire components

[0082] 21 Axial extension

[0083] 22 Internal Lumen / Collector Channel

[0084] 23 through holes

[0085] 24 Fiber Optic

[0086] 25 Ultrasonic Transmitter

[0087] 26 Capture Features

[0088] 27 Sleeve or cover

[0089] 28 Actuator switch for sleeve or cover

[0090] 29 curved platform

[0091] 30 First upper blade

[0092] 31 Second upper blade

[0093] 32 handle trigger

[0094] 33 Blade heating element

[0095] 34 Lancet type / Hollow / Wire

[0096] 35 Bilateral / Dual Device

[0097] 36 Overhang

[0098] 37 Non-beveled platform, angled blade

[0099] 38 Wedge

[0100] 39 Sliding Punch DETAILED DESCRIPTION

[0101] The present invention relates to an ophthalmic knife and methods 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, 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 methods of use thereof for treating various medical conditions, including but not limited to ocular diseases such as glaucoma, using minimally invasive surgical techniques.

[0102] ITraditional treatment of eye diseases

[0103] A. Glaucoma

[0104] Glaucoma is considered one of the leading causes of blindness worldwide [1]. A modifiable risk factor for the disease is reported to be intraocular pressure (IOP). Traditional treatments have focused on lowering IOP with antihypertensive medications or through the use of laser or incisional surgery. The primary areas of aqueous humor outflow obstruction, and subsequently IOP accommodation, are thought to be located in the proximal trabecular meshwork (TM) and distal outflow structures [2-4]. Goniotomy or trabeculectomy in adult patients with glaucoma has not been associated with significant success in lowering IOP [5, 6]. Conversely, these procedures have been reported to be more successful in congenital glaucoma, where the cell membrane covering the TM is thought to be the primary factor in the resistance to aqueous humor outflow [7]. Recently, attempts have been made to remove the TM in adult patients using a novel visco-intraoperative approach to trabeculectomy, with mixed results [8-10].

[0105] One reason for the poor long-term efficacy of this approach in adults may be related to incomplete removal of the TM and the cell membranes of the remaining TM leaflets, with subsequent IOP elevation.

[11] It is unclear whether this approach is more effective than simple TM incisions (e.g., MVR blade goniotomy) or procedures that cauterize the TM by tissue resection (e.g., (Neomedix, Tustin, California, USA)). The dual blade device is specifically designed to conform to the drainage angle anatomy of the human eye. Although not limiting of the present invention, the device is intended to perform a visco-intraoral trabeculectomy by engaging the TM and cutting the target tissue while minimizing the lobule remaining in place and damage to adjacent tissue. The device was designed and manufactured by the University of Colorado Eye Center (US Provisional Patent Application No. 61 / 637611)

[12] . The tissue effects from the novel device were compared to those from goniotomy and trabeculectomy using a microvitreoretinal (MVR) blade (BD, Franklin Lakes, New Jersey, USA). A human ocular perfusion study was also completed to evaluate the IOP lowering efficacy of each method.

[0106] Recently, there has been an increasing trend towards innovative minimally invasive glaucoma surgery (MIGS). Although the long-term efficacy of these incisional procedures has been demonstrated, the risks and drawbacks of protective filtering surgery and ductal shunt surgery have driven this paradigm shift. Disadvantages of traditional incisional surgery include unpredictable IOP reduction results, prolonged visual recovery, long-term risks of infection and vision loss, frequency of follow-up, and long-term failure rates

[13] . Examples include endoscopic cyclophotocoagulation, the use of Both viscoelastic trabeculectomy and canaloplasty using the iScience illuminated catheter (iScience, Menlo Park, California, USA) were introduced to address the limitations of full-thickness surgery, most notably the elimination of the presence of filtering blebs. However, the major disadvantages of all of these procedures are the additional equipment costs and, in some cases, a steep learning curve. The increased equipment costs pose a particular challenge to providers, hospitals, and surgical centers, which may require multiple procedures to recoup the initial investment. Providers and patients may also face opposition from insurance companies to new procedures that lack long-term efficacy data. The need for additional equipment also limits access to these procedures for patients in underserved areas of the world.

[0107] B. Goniotomy

[0108] Goniostomy is often referred to as a surgical procedure primarily used to treat congenital glaucoma. It may be caused by the developmental arrest of certain structures in the anterior (front) segment of the eye. These structures include the iris and ciliary body, which produce the aqueous humor needed to maintain eye integrity. These structures develop abnormally in the eyes of patients with isolated congenital glaucoma. Instead, the structure overlaps and blocks the trabecular meshwork, which is the main drainage system for aqueous humor. Due to this blockage, the trabecular meshwork itself becomes thicker, and the drainage holes in the meshwork become narrower. These changes cause an excess of fluid in the eye, thereby generating pressure that damages the internal structures of the eye and causes glaucoma.

[0109] Generally, congenital glaucoma is caused by a decrease or even complete blockage of fluid outflow from the eye. Eye syndromes and anomalies that predispose children to congenital glaucoma include Rieger anomaly, Peter anomaly, Axenfeld syndrome, and Axenfeld-Rieger syndrome. Systemic diseases that affect the eye in ways that may lead to glaucoma include Marfan syndrome, rubella (German measles), and cataracts, including neurofibromatosis and Sturge-Weber syndrome. Because these conditions affect the entire body as well as the eye, the child's pediatrician or family doctor will help diagnose and treat them.

[0110] One purpose of goniotomy is to clear the blockage of aqueous humor outflow from the eye, thereby reducing intraocular pressure (IOP). Although it is not necessary to understand the mechanism of the invention, it is believed that lowering IOP helps stabilize corneal enlargement and the expansion and stretching of the eye, which often occurs in congenital glaucoma. However, the size of the eye may not return to normal. Most importantly, once the outflow of aqueous humor improves, the damage to the optic nerve will stop or be reversed. The patient's vision may improve after the operation.

[0111] Before the surgeon begins surgery, the patient may be given a miotic, a medication that causes the pupil to constrict. Partial closure can improve the surgeon's view of and access to the trabecular meshwork; it can also protect the lens of the eye from damage during surgery. Other medications may be administered to lower intraocular pressure. Goniostomy can be performed without the use of miotics. In one embodiment, the present invention can be used to provide a dilated (non-miotic) pupil, such as devices described in the prior art.

[0112] Once the necessary medications have been administered and the patient is anesthetized, the surgeon can use forceps or sutures to stabilize the eye in the correct position. The patient's head can be rotated away from the surgeon to make it easier to view the internal structures of the eye. Next, the surgeon punctures the cornea with a needle knife or goniotomy knife while observing the inside of the eye through a microscope or magnifying glass. While the surgeon performs the goniotomy, an assistant can use a syringe to introduce fluid into the anterior chamber of the eye through a viscoelastic tube.

[0113] The gonioscopic lens can then be placed in the eye. As an assistant rotates the eye, the surgeon sweeps the blade or needle through a 90-120° arc in the eye, making an incision in the anterior trabecular meshwork, avoiding the posterior portion of the trabecular meshwork to reduce the risk of damaging the iris and lens. Endoscopic visualization can also be used to guide the cutting. In one embodiment, the device of the present invention can be placed at the end of an endoscope, eliminating the need for a gonioscopic lens during the treatment. Once the knife and tube are removed, saline solution can be introduced through the hole to maintain the integrity of the eye, and the hole is closed with sutures. The surgeon then administers antibiotics and corticosteroids to the eye to prevent infection and reduce inflammation. The head can then be rotated away from the incision site so that blood cannot accumulate. The second eye can be operated on simultaneously. If the process needs to be repeated, another area of ​​the eye can be treated.

[0114] A previous device is described in U.S. Patent No. 7,959,641 to Sorensen et al., “Tubular Cutter Device and Methods For Cutting and Removing Strips of Tissue from the Body of a Patient,” issued June 14, 2011;

[14] . See also International Publication No. WO 2004 / 110501

[15] and relevant portions of U.S. Publication No. US2007 / 0276420

[16] . This reference discloses a device for cutting a strip of tissue having a width of approximately 50-200 μm from the trabecular meshwork. The device has a first cutting edge and a second cutting edge formed at the distal end of a cutting tube. The distal end may be blunt and, in certain applications, configured and adapted to facilitate insertion of the device into its intended location, i.e., Schlemm's canal. In addition, one or more bends or curves may optionally be formed to facilitate its use. The tip of the device can be advanced through the trabecular meshwork and into Schlemm's canal so that the cutting edge cuts a strip of the trabecular meshwork, creating an opening for drainage of the aqueous humor. While this reference teaches a cutting blade having dual cutting sides and a tip for placement in Schlemm's canal for removing trabecular meshwork with a selectable bend / curvature, the use of a 0.3 mm blade width is not specifically mentioned.

[0115] Another device is described in Huculak, U.S. Patent Publication No. US 2009 / 0287233, “Small Gauge Mechanical Tissue Cutter / Aspirator Probe for Glaucoma Surgery,”

[17] . This reference discloses the use of a small gauge mechanical tissue cutter / aspirator probe to remove the trabecular meshwork. The probe can be guided into Schlemm's canal and moved forward with the curvature of the trabecular meshwork. This movement causes the trabecular meshwork to be fed into the cutting port of the cutter, thereby cutting and removing the trabecular meshwork that is obstructing 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 to 0.36 mm in diameter. The cannula can be tapered so that its distal end measures approximately 0.25 to 0.36 mm (approximately 0.3 mm for Schlemm's canal). In addition, the leading edge can be curved to enhance its ability to penetrate the trabecular meshwork. While this reference teaches the use of a small gauge knife approximately 0.25 to 0.36 mm in diameter with a sharpened or blunt leading edge for piercing the trabecular meshwork and entering Schlemm's canal with a cutting port to cut the trabecular meshwork, it does not itself teach a dual sharp edge cutting blade.

[0116] Another device is described in Baerveldt et al., “Minimally Invasive Glaucoma Surgical Instrument and Method,” U.S. Patent Publication No. US 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. US 2006 / 0106370

[21] and US 2002 / 0111608

[22] ). This reference discloses the use of a cutting probe to cut and remove the trabecular meshwork. The probe includes a tip of approximately 25 Ga. (approximately 0.5 mm). The tip also includes a pad that serves as a guide for entering Schlemm's canal. The sharpened end of the pad is used to pierce the trabecular meshwork. The trabecular meshwork is cut using a rotatable blade or in a guillotine manner. While the reference discloses the use of a cutting probe having an approximately 25 Ga. tip that includes a pad for piercing the trabecular meshwork and targeting Schlemm's canal, it does not itself mention the use of a double sharp-edged cutting blade sized for navigating Schlemm's canal (0.3 mm). Another device is described in Huculak, "Small Gauge Mechanical Tissue Cutter / Aspirator Probe for Glaucoma Surgery," International Publication No. WO 2009 / 140185

[23] (see also selected portions of European Patent No. EP 2303203

[24] ). The reference discloses the use of a small gauge mechanical tissue cutter / aspirator probe for removing the trabecular meshwork. The probe consists of an outer cannula and an inner cannula. The distal end of the inner cannula is configured to cut tissue when it enters port 310. The inner cannula moves up and down to cut the tissue. The outer cannula includes a retractable pick having a sharp end for piercing the trabecular meshwork. Due to the size of Schlemm's canal, the outer cannula preferably has a distal diameter of approximately 0.25 to 0.36 mm. The cannula may be tapered so that its distal end measures approximately 0.25 to 0.36 mm (Schlemm's canal is approximately 0.3 mm). While this reference discloses using a probe having a size between 0.25 and 0.36 mm to pierce the trabecular meshwork and place it into Schlemm's canal, it does not mention using a double sharp-edged cutting blade with a curvature to navigate Schlemm's canal.

[0117] Bergheim, O.B. and Gharib, M., “Apparatus and Method for Treating Glaucoma,” WIPO Patent WO / 2001 / 078631, Application No. PCT / US2001 / 007398, filed March 8, 2001, describes another device. (Published October 25, 2001)

[25] . This reference discloses the use of a cutting member located at the distal end of a tube, the cutting member comprising a blade, a pointed guide member, and a sharpened distal end of the tube. The cutting member is configured to form an opening in the trabecular meshwork for placement of a seton into Schlemm's canal. The blade comprises a microblade having a size ranging from 20 to 40 Ga, preferably 30 (0.3 mm) Ga. While this reference discloses using a cutting member sized 20 to 40 Ga. to cut the trabecular meshwork and deliver a seton to Schlemm's canal, it does not mention using a double sharp edge cutting blade with a curvature to navigate Schlemm's canal.

[0118] Another device is described in U.S. Patent No. 4,501,274

[26] to Skjaerpe, Finn, “Microsurgical Instrument” (issued February 26, 1985; see also selected portions of European Patent EP 0 073 803

[27] ). This reference discloses a microsurgical probe having a cutting member comprising two blades projecting from the probe in different directions, each blade having at least one sharpened cutting edge. The cutting member has a double cutting edge, wherein the two cutting edges are angled apart so that they form a V-shape that conforms to the topographical features of the eye at Schlemm's canal and the trabecular meshwork. The probe has a diameter of approximately 0.25 mm and a blade width of 0.3 to 0.5 mm. The blade also includes cutting edges on both sides so that the probe can pass through Schlemm's canal in both directions. While this reference discloses a double blade having at least one sharpened cutting edge for cutting the trabecular meshwork and the inner wall of Schlemm's canal, it does not per se mention navigating the curvature of Schlemm's canal.

[0119] Another device is described in U.S. Patent Publication No. US 2006 / 0149194

[28] to Conston et al., “Ophthalmic Microsurgical System” (see also International Publication No. WO 2003 / 045290

[29] , European Patent No. EP 1455698

[30] , and selected portions of Korean Patent No. KR 1020040058309

[31] ). This reference discloses a microsurgical system having an outer microcannula sheath including an inner member sized to fit within Schlemm's canal, which has a diameter of approximately 50 to 200 μm. The outer diameter of the inner member is in the range of 50-240 μm so as to fit within the outer cannula, which has an inner diameter of 50-250 μm. The outer microcannula and the inner member are each adapted to the curvature of Schlemm's canal, and the inner member optionally includes a cutting tool at the distal end having a diamond or sapphire tip or blade or similar element. Although this reference discloses a microprobe for cutting the trabecular meshwork and targeting Schlemm's canal, it does not itself mention the use of a dual sharp-edged cutting blade to pierce the trabecular meshwork and target Schlemm's canal.

[0120] Another device is described in U.S. Patent Publication No. US 2007 / 0073275

[32] to Conston et al., “Ophthalmic Microsurgical Instruments” (see also International Publication No. WO 2004 / 093761

[33] and selected portions of European Patent No. EP 1615604

[34] ). This reference discloses a microsurgical instrument that can be inserted directly into Schlemm's canal to allow controlled treatment or removal of adjacent tissue (such as TM). The instrument includes an outer sheath microcannula and an inner member, wherein the distal end of the instrument can be curved to approximate the curvature of Schlemm's canal. The instrument includes a cutting device for resecting the target tissue. The microcannula is sized to accommodate Schlemm's canal (approximately 200 microns in diameter) and has an outer diameter of approximately 100 to 350 microns. The distal end of the inner member can be beveled or sharpened to provide a cutting action. While this reference discloses a microprobe for cutting the trabecular meshwork and targeting Schlemm's canal, it does not itself mention the use of a dual sharp-edged cutting blade to pierce the trabecular meshwork and target Schlemm's canal.

[0121] Another device is described in Huculak, U.S. Patent Publication No. US 2011 / 0230877, “Pulsed Electric Field Probe for Glaucoma Surgery”

[35] . This reference discloses the use of a small gauge pulsed electric field probe to remove the trabecular meshwork. The distal end of the probe includes a pick adapted to fit into Schlemm’s canal so that the electric pulse field can be used to separate and remove the trabecular meshwork. The pick has a sharpened end so that it can pierce the trabecular meshwork so that the pick can be placed into Schlemm’s canal. The pick is retractable. The probe has a diameter between 0.25 and 0.36 mm. Although this reference discloses the use of a probe between 0.25 and 0.36 mm in size to pierce the trabecular meshwork and place it into Schlemm’s canal, it does not mention the use of a double sharp edge cutting blade having a curvature to navigate Schlemm’s canal.

[0122] Another device is described in Pantcheva, MB and Kahook, MY (2010) Ab Interno Trabeculectomy, Middle East Afr. J. Ophthalmol. 17(4), 287-289

[10] . This reference is an update of the methods used in this field. Overview of the device.

[0123] Another device known in the art for visco-intraoperative trabeculectomy is called a “gonioscraper,” as described by Jacobi et al.

[36] . This device consists of a handle and a curette tip that is used to remove TM by scraping the curette within Schlemm’s canal. The curette tip is aligned with the handle and does not conform to the geometry of the drainage angle and adjacent structures. Following promising preclinical studies, a nonrandomized clinical trial of 25 eyes was completed

[37] . Preoperative IOP was 34.7 ± 7.1 mm Hg with a mean follow-up of 32 months using 2.2 ± 0.56 medications. Fifteen eyes (60%) were successful based on the success criterion of IOP ≤ 19 mm Hg after 1 decompression agent. Nevertheless, some patients experienced complications, including localized Descemet’s membrane detachment and / or hyphema. Histological analysis of banked eyes treated with curettage showed successful removal of TM tissue, but damage to the septum and endothelium of the external and posterior walls of Schlemm’s canal

[36] . In the data presented herein, similar damage to the adjacent sclera was also observed when an MVR blade was used, but was notably absent when an embodiment of a dual-blade device as contemplated by the present invention was used.

[0124] In the past few years, there have been Both successful and failed devices have been reported [8-11, 38]. In a retrospective study comparing trabeculectomy with viscoelastic trabeculectomy, Jea et al found that trabeculectomy with viscoelastic trabeculectomy was associated with a 2-year survival rate. The success rate of treated eyes is low[8]. Of the 115 eyes treated, only 22.4% were successful, with failure defined as an IOP >21 mm Hg or a <20% decrease in IOP. It is conceivable that after the initial opening of the TM, the residual leaflet obstructs Schlemm's canal and / or the more distal collecting ducts, leading to the failure of the intervention. This can be overcome with a double-blade device. This failure mechanism after treatment allows for more complete removal of TM tissue without residual leaflets.

[0125] The improved double blade device geometry is designed to minimize any impact on adjacent tissues such as the Descemet's membrane by utilizing specific angles between the handle and the distal blade, as well as specific angles between the cutting blade and the adjacent cutting tip. Kahook M., WO 2013 / 163034

[39] (incorporated herein by reference) reported several practical advantages of the double blade device for visco-intraoperative trabeculectomy. First, the double blade device is reusable and can be added to a standard cataract surgical tray. Second, the lack of moving parts or the need for coupled irrigation or a separate power source makes it inexpensive to manufacture and allows for rapid access to surgical expertise. This will enable easy and economical access to new technologies, especially in underserved areas of the world. In contrast, conventional The device requires a substantial initial investment in the irrigation / aspiration unit and generator, in addition to the cost of disposable items such as the handpiece and tube. The simple design and material requirements of the double-blade device embodiment will be more economical. Finally, compared to other techniques for TM removal, embodiments of the double-blade device design conform to the anatomy of Schlemm's canal, minimize damage to adjacent tissues, and provide good control of the resected tissue. In summary, the conventional double-blade device can perform visco-intra-orbital trabeculectomy with or without cataract extraction.

[0126] II Ophthalmic Knife

[0127] The following detailed description and the accompanying drawings are only for the purpose of describing and explaining certain preferred embodiments or examples of the present invention, and are not intended to be an exhaustive description of all possible embodiments or examples of the present invention. Therefore, the following detailed description and the accompanying drawings should not be interpreted as limiting the scope of the claims described in this patent application and any patent issued therefrom in any way.

[0128] In one embodiment, the present invention contemplates an ophthalmic knife for cutting ocular tissue, such as trabecular meshwork (TM). Specifically, the knife can have a device tip that provides access to Schlemm's canal via its size (e.g., between approximately 0.3-2 mm wide) and a configuration in which the entering blade tip curves upward, providing a ramp-like action for cutting tissue (e.g., trabecular meshwork tissue).

[0129] Compared with other conventional devices, the specific advantages of some embodiments described herein include but are not limited to:

[0130] 1. No mechanical moving parts

[0131] 2. Does not ablate or burn tissue

[0132] 3. A multi-blade configuration could be placed on the side of the device to cut the TM in a precise manner, leaving essentially no TM behind (current devices leave a large number of residual TM leaflets, which then leave scars).

[0133] 4. Access to Schlemm's canal is accomplished using the end of a blade. Other similar devices use a bladeless backing plate to enter Schlemm's canal.

[0134] 5. The dimensions of these devices allow for precise, complete cutting and installation in Schlemm's canal.

[0135] 6. The tip of the blade may be angled upward to the multiple side blades, thereby creating a surface that presents the TM to the blade, subsequently allowing for more precise cutting.

[0136] 7. The distal end of the device is to follow a 2 +b 2 =c 2 of a right triangle.

[0137] 8. The distal end slopes upward from the piercing blade towards a parallel blade positioned above the level of the TM.

[0138] 9. When the device is pushed, the ramp raises the TM out of Schlemm's Canal, thereby elevating the TM above its normal position on the inner wall of Schlemm's Canal.

[0139] 10. Once the TM is elevated and the device is advanced, the TM is presented to the parallel blades, resulting in a clean cut of the tissue.

[0140] 11. Stretching the tissue away from its natural position on the inner wall of Schlemm's canal is a critical step for success.

[0141] 12. The piercing tip blade is discontinuous with the blade on top of the bevel (ie there is no continuous sharpened component from the tip to the cutting™ blade). This area of ​​the bevel typically has no cutting edge.

[0142] 13. In one embodiment, the device has a flat bottom so that once the device is laid flat (heel down), the majority of the bottom of the device is not in contact with the outer wall of Schlemm's canal (the curvature of the canal causes this (thus, the bottom of the pad is lifted up by the canal). This means that when the pad of the present invention is advanced, there is less contact and friction with the pad.

[0143] 14. All tissue cuts (except the initial puncture with the tip of the blade) are made away from Schlemm's canal (elevated toward the anterior chamber).

[0144] A. Ophthalmic Knife Platform

[0145] In some embodiments, the present invention contemplates an ophthalmic knife comprising a platform. In some embodiments, the platform comprises an inclined portion, thereby forming a bevel or wedge shape 38. In some embodiments, the platform is attached to a transverse blade, preferably on a transverse side of the platform, see Figure 1 .

[0146] In one embodiment, the first transverse blade 10 and the second transverse blade 11 are aligned vertically with the bottom of the bevel platform 5. In one embodiment, the present invention relates to a device 12 comprising a handle 1 and a bevel platform 5, wherein the platform 5 is set at a specific angle and orientation relative to the handle 1. In one embodiment, the present invention relates to a device 12 comprising a handle 1 and a bevel platform 5, wherein the platform 5 is free to rotate in at least two dimensions. In one embodiment, the handle 1 and the bevel platform 5 are operably attached at an angle between 90 and 120 degrees on the YZ axis. In one embodiment, the handle 1 and the bevel platform 5 are operably attached at an angle between 90 and 180 degrees on the XZ axis. In one embodiment, the platform 5 is free to rotate in the XY dimension relative to the handle 1. In one embodiment, the platform 5 maintains a fixed angle in the XY, XZ and YZ 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 bevel platform 5 includes a first end / bevel platform end / insertion blade end 6 and a second end / back portion 7 of the bevel platform, wherein the second end / back portion 7 of the bevel platform is between two and thirty times thicker than the first end / bevel platform end / insertion blade end 6. In one embodiment, the dimensions of the bevel platform 5 are given by Formula A. 2 +B 2 =C 2, where A is the length of the bevel platform 5 from the insertion blade end 6 to the back of the bevel platform 7, B is the height of the bevel platform 5, and C is the length of the inclined portion. In one embodiment, the height of the bevel platform 5 does not exceed 0.5 mm. In one embodiment, the length of the bevel platform 5 from the insertion blade end 6 to the back of the bevel platform 7 does not exceed 1.0 mm. In one embodiment, the first end / bevel platform end / insertion blade end 6 comprises a fine surgical lancet. In one embodiment, the first end / bevel platform end / insertion blade end 6 comprises an angle between 20 and 90 degrees. In one embodiment, the bevel platform 5 increases in thickness in the Y-axis direction from the fine blade end toward the second end / back of the bevel platform 7. In one embodiment, the first end / bevel platform end / insertion blade end 6 comprises a tip with a fine edge having surgical sharpness. In one embodiment, the first end / bevel platform end / insertion blade end 6 comprises a lancet. In one embodiment, the bevel platform 5 further comprises a first blade 10 and a second blade 11. In one embodiment, the first blade 10 is attached to the first side 8 of the second end / back of the bevel platform 7. In one embodiment, the first blade 10 and the bevel platform 5 are operably attached at an angle between 90 and 180 degrees on the YZ axis. In one embodiment, the angle is preferably between 90 and 120 degrees on the YZ axis. In one embodiment, the second blade 11 and the bevel platform 5 are operably attached at an angle between 90 and 120 degrees on the YZ axis. In one embodiment, the first blade 10 and the handle 1 are operably positioned at an angle between 90 and 120 degrees on the YZ axis. In one embodiment, the second blade 11 and the handle 1 are operably positioned at an angle between 90 and 120 degrees on the YZ axis. In one embodiment, the second blade 11 is attached to the second side 9 of the second end / back 7 of the bevel platform. Figure 2 In one embodiment, wherein the front blade tip is a retractable blade tip.

[0147] In one embodiment, the sloped platform 5 increases in thickness from the second side 9 toward the first side 8 in the direction of the X-axis. Figure 3 In one embodiment, the bevel platform 5 increases in thickness from the second side 9 toward the first side 8 in the direction of the X-axis, and the bevel platform 5 increases in thickness from the fine blade tip of the first end 6 toward the second end / back 7 of the bevel platform in the direction of the Y-axis.

[0148] In one embodiment, the bevel platform 5 increases in thickness from the first side 8 toward the second side 9 in the direction of the X-axis. In one embodiment, the bevel platform 5 increases in thickness from the first side 8 toward the second side 9 in the direction of the X-axis, and the bevel platform 5 increases in thickness from the fine blade end of the first end 6 toward the second end / back 7 of the bevel platform in the direction of the Y-axis. In one embodiment, the first blade 10 and the second blade 11 extend above the top surface of the second end / back 7 of the bevel platform. In one embodiment, the first blade 10 and the second blade 11 are positioned at an angle of approximately 100 to 140° relative to the top surface of the second end / back 7 of the bevel platform. In one embodiment, the bevel platform 5 is approximately 0.3 mm wide. In one embodiment, the bevel platform 5 is approximately 0.2 mm wide. In a preferred embodiment, the bevel platform 5 is approximately 0.25 mm wide. In one embodiment, the bevel platform 5 is approximately 1.0 mm long. In one embodiment, the bevel platform 5 is approximately 0.4 mm high. In one embodiment, the highest points on the bevel platform 5 are the first blade and the second blade. The device 12 can be provided as a pre-sterilized, single-use probe or tip that can be attached 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 feature 26. In one embodiment, the gripping feature 26 is selected from a forceps element and a tweezers element. In one embodiment, the gripping feature 26 comprises a sleeve 27 extending over the shaft, wherein the handle comprises a sleeve actuator switch.

[0149] B.Dual platform / double blade ophthalmic knife

[0150] In one embodiment, the present invention contemplates a dual platform / dual blade ophthalmic knife comprising a handle 1 connected to a shaft 3, the shaft being connected to a first platform comprising a first blade and a second blade and a first front blade, the second platform comprising a third blade 14 and a fourth blade 15 and a second front blade tip. Figure 4A In one embodiment shown, the device comprises two oppositely facing platforms, each platform having at least two transverse blades, and each platform having a blade tip. Figure 4B In another embodiment, the apparatus comprises two generally parallel platforms, each having at least two transverse blades, and each having a blade tip. In one embodiment, the first front blade tip and the second front blade tip are retractable blade tips. In another embodiment, the apparatus comprises at least two staggered platforms. In another embodiment, the apparatus comprises at least two staggered platforms, each having at least two transverse blades, and each having a blade tip.

[0151] C. Four-blade ophthalmic knife

[0152] In one embodiment, the present invention contemplates a four-blade ophthalmic knife comprising a handle 1 connected to a shaft 3 connected to a platform comprising four cutting blades and a front blade tip, see Figure 5 In one embodiment, two upper (shaft) blades (30 and 31) are positioned above lower (platform) blades (10 and 11), which can move up and down to cut the TM between the upper and lower blades (similar to scissors on both sides of a ramp). In one embodiment, the upper blades can be moved by a trigger mechanism 32, such as squeezing the handle 1 (like MST forceps).

[0153] D. Ultrasonic ophthalmological knife

[0154] In one embodiment, the present invention contemplates an ultrasonic ophthalmic knife comprising a handle 1, a shaft 3, a front blade tip, and a platform, wherein the platform comprises an ultrasonic transmitter 25. In one embodiment, the ultrasonic ophthalmic knife is as follows Figure 6 shown.

[0155] E. Forceps ophthalmic knife

[0156] In one embodiment, the present invention contemplates a forceps-shaped ophthalmic knife comprising a handle 1 connected to a shaft 3, wherein the shaft is connected to a lower platform and an upper platform. In one embodiment, the platforms are curved. In one embodiment, the first platform is guided into a tube and the second platform is inside the handle 1, tool shaft 3 or barrel 16. In one embodiment, the first platform is pushed into the TM and then the second platform is pushed toward the first platform to capture the TM between the first and second platforms. In one embodiment, the platforms further comprise blades or grooves on the first and second platforms. In one embodiment, the platforms have complementary surfaces. In one embodiment, the complementary surfaces engage at a surface of an occlusal portion. In one embodiment, the surface of the occlusal portion is the edge of the blade. In one embodiment, the platforms engage with each other and cut the TM strip into an 8 mm strip. In one embodiment, the device as Figure 7 shown.

[0157] F. Clamping ophthalmic knife

[0158] In one embodiment, the present invention contemplates a clamping ophthalmic knife comprising a handle 1 connected to a shaft 3, the shaft comprising a transverse alligator clip 17, and a platform 5 connected to the shaft 3, the platform 5 comprising a first transverse blade 10a and a front blade tip 6. In one embodiment, the alligator clip 17 comprises a first alligator clip blade 18 and a second alligator clip blade 19. In one embodiment, the alligator clip 17 comprises a clip with a spring that closes an articulated jaw. In one embodiment, the alligator clip comprises a clip with a spring that closes a serrated jaw. Figure 8 An example of an alligator clip (17) is shown. 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 motion of the top jaw of the alligator clip pulls the TM in, cuts it, and then pushes it out from the back.

[0159] G. Lancet ophthalmic knife

[0160] In one embodiment, the present embodiment contemplates a lancet ophthalmic knife comprising a handle 1 connected to a shaft 3, wherein the shaft is connected to a wire element 20. In one embodiment, the wire element is shaped to be retractable into the shaft 3. In one embodiment, the wire element is rigid. In one embodiment, the shape of the wire element can be varied, such as having an end that is 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, such as Figure 9 As shown. In one embodiment, the wire element 20 can be triangular, square, rectangular, or oval. In one embodiment, the wire element 20 is pushed into the TM. In doing so, the wire element 20 stretches and opens Schlemm's canal. The wire element 20 is then advanced through the canal, causing the sharpened wire to cut the TM, leaving behind a long strip of TM.

[0161] H. Axial Blade Ophthalmic Knife

[0162] In one embodiment, the present invention contemplates an axial blade ophthalmic knife comprising a handle 1 connected to a shaft 3, the shaft being connected to a first blade and a second blade. In one embodiment, the axial blade comprises an axial extension 21 comprising at least one distal blade. In one embodiment, the distal blade is secured to the axial extension wherein the distance between the blade and the edge of the distal end of the axial extension comprises an overhang 36. In one embodiment, the overhang 36 limits the depth of the incision. Figure 10In one embodiment shown, the device comprises two parallel blades ( 10 and 11 ) connected to the axial extension 21 , wherein the space between the blades and the edge of the axial extension 21 comprises an overhang 36 .

[0163] IV-shaped blade ophthalmic knife

[0164] In one embodiment, the present invention contemplates a V-blade ophthalmic knife comprising a handle 1 connected to a shaft 3 comprising a first blade, the shaft being connected to a platform, wherein the first blade overhangs the platform such that the first blade and the platform are connected at an angle. In one embodiment, the attachment of the shaft 3 to the platform and the angle of overhang provide a surface for shearing tissue. In one embodiment, the knife further comprises a pass-through window for cutting tissue. Figure 11 A side view of one embodiment of the device is provided, wherein the dashed lines indicate one embodiment of the internal through-hole 23 .

[0165] J. Ophthalmic Devices

[0166] like Figure 16 As shown, device 112 can have a platform 105 having an extension member 117. Platform 105 has a front end 106 and a rear end 107. Platform 105 can have similar features to platform 5, with the addition of extension member 117. Device 112 can include a slidable sleeve 118 disposed on shaft 104 and configured to slide back and forth over the outer shaft surface 103 of shaft 104 and at least a portion of platform 105. Sleeve 118 can be sized and shaped to provide a fluid flow channel 119 between shaft surface 103 and inner sleeve surface 121. For example, fluid flow channel 119 can be configured to deliver a local balanced salt solution, a drug, a viscoelastic agent (e.g., OVD), or a therapeutic agent to the site or to flush blood backflow.

[0167] Sleeve 118 can have a sleeve end 128 from which engagement portion 123 can extend. When sleeve 118 is slidably disposed in a closed position toward extension member 117, engagement portion 123 is sized and shaped to engage extension member 117. Engagement portion 123 has a surface 124 configured to grasp tissue that has been cut or dissected by platform 105. For example, sleeve 118 can be positioned in a normally open position such that a gap 125 exists between surface 124 and extension member 117. Gap 125 can have a maximum width when sleeve 118 is maximally retracted, wherein the width of gap 125 decreases when sleeve 118 is moved to a fully engaged position against the extension member, such that gap 125 can have little or no width.

[0168] The gap 125 can provide an outlet for fluid to be dispersed from the fluid flow channel 119. Fluid can also be dispersed from the end portion 129 of the fluid flow channel 119. The fluid flow channel 119 can be configured to draw fluid back from the site. For example, fluid from the site (e.g., blood, excess flushing fluid) can flow into the gap 125 and / or end portion 129, flow through the fluid flow channel 119, and out of the handle end of the device 112. As another example, the fluid channel 119 can be configured to transport fluid out of the gap 125 and / or end portion 129, and the returning fluid can move upward back to the device 112 through a lumen (not shown) inside the shaft 104. In one aspect of the present disclosure, the lumen can be disposed outside the shaft 104 and within the fluid flow channel 119.

[0169] Surface 124 can 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 can then be disposed of by removing device 112 from the site or by using another device (e.g., phacoemulsification). In one aspect of the present disclosure, surface 124 can be provided as a force surface configured to press tissue downward onto cutting surface 127 of extension member 117. Thus, platform 105 can have multiple cutting portions.

[0170] like Figure 21 As shown, sleeve 118 can be coupled to an engagement member of a handle, such as squeeze handle 150. Thus, when an actuating member (e.g., a trigger) 152 of handle 150 is squeezed, sleeve 118 can slide toward platform 105, thereby providing for grasping and / or cutting of tissue between surface 124 and extension member 117. Similarly, when the squeezing force on handle 150 is removed (e.g., by releasing trigger 152), sleeve 118 can slide away from platform 105, thereby releasing tissue. In one aspect of the present disclosure, the biasing force on sleeve 118 can be reversed. For example, when handle 150 is open (e.g., not squeezed), sleeve 118 can be positioned so that surface 124 engages extension member 117 (e.g., sleeve 118 is in a closed position), and when handle 150 is squeezed, sleeve 118 can slide away from platform 105, opening gap 125 so that tissue or an object can be engaged.

[0171] like Figure 17As shown, the device 212 can have a platform 205 having an extension member 217. The platform 205 has a front end 206 and a rear end 207. The platform 205 can have similar features to the platform 5, with the addition of the extension member 217. The device 212 can include a slidable sleeve 218 disposed on the shaft 204 and configured to slide back and forth on the outer shaft surface 203 of the shaft 204. The sleeve 218 can be sized and shaped to provide a fluid flow channel 219 between the shaft surface 203 and the inner sleeve surface 221. For example, the fluid flow channel 219 can be configured to deliver a local balanced salt solution, a drug, a viscoelastic agent (e.g., OVD), or a therapeutic agent to the site or to flush blood backflow.

[0172] The extension member 217 can be flexibly coupled to the rear end 207 of the platform 205. The extension member 217 can be an integral part of the platform 205 that extends outwardly at an angle. Figure 17 As shown, the extension member 217 can be biased in an open position and configured to be urged toward a closed position when the sleeve 218 slides toward the platform 205, thereby exerting a force on the extension member 217 that is directed inwardly toward the rear end 207. Thus, the extension member 217 can be configured as a grasper (e.g., a forceps) that grasps tissue. Similarly, the sleeve 218 can slide on the shaft 204 away from the platform 205, and the biasing force on the extension member 217 can cause the extension member to move (e.g., open, rebound) to release the tissue.

[0173] The size and shape of the extension member 217 can substantially mirror the opposite portion of the rear end 207 of the platform 205. In one aspect of the present disclosure, the device 212 can have a plurality of extension members 217 spaced about the circumference of the shaft 204. Here, the plurality of extension members 217 can each be configured to move toward the shaft 204 or the platform 205 when the slidable sleeve 218 moves toward the platform 205. Thus, each extension member 217 can be configured to grasp a different portion of tissue or an object.

[0174] The rear end 207 may have a surface 207a, and the extension member 217 may have a surface 217a. A portion or all of the surface 207a and / or the surface 217a may be sharpened cutting surfaces. For example, one of the surfaces 207a, 217a may be unsharpened, while the other of the surfaces 207a, 217a may be sharpened, or both surfaces 207a, 217a may be sharpened, thereby providing a cutting function on the rear end 207 of the platform 205. As another example, both surfaces 207a, 217a may be unsharpened, thereby providing a gripping function for the rear end 207 of the platform 205.

[0175] like Figure 18A and Figure 18B As shown, the device 312 can have a shaft 304 and a platform 305 having a front end 306 and a rear end 307. The shaft 304 can be divided into two shaft segments 304a and 304b. The shaft segments 304a, 304b can be offset from each other in the non-activated or default position, thereby providing a gap 325 between the shaft segments 304a, 304b. Figure 18A As shown, the non-triggered position can be assumed when the movable sleeve 318 is pulled away from the platform 305. When the slidable sleeve 318 is moved toward the platform 305 (e.g., activated, triggered), the sleeve 218 can exert a force on the shaft segments 304a, 304b, causing the shaft segments 304a, 304b to move toward each other, as shown in FIG. Figure 18B As shown. Movement of shaft segments 304a, 304b toward each other can provide a grasping function, allowing split shaft 304 to grasp tissue or an object. As another example, movement of shaft segments 304a, 304b toward each other can provide a cutting function, allowing split shaft 304 to cut tissue or an object. Platform 305 can have a similar structure and / or function as platform 5.

[0176] Likewise Figure 18A and Figure 18B As shown, the platform 305 and / or sleeve 318 may be sized and shaped such that the sleeve 318 is not configured to slide across the platform 305. Figure 18B In the fully closed position of the device 312 shown, the sleeve 318 extends only over a portion of the platform 305, or does not extend over the platform 305 at all. In some aspects of the present disclosure, such as Figure 19A As shown, the sleeve 318 can be sized and shaped to fit completely over the platform in a jacketed or closed position and to be slidably moved away from the platform 305 to an unjacketed or open position to expose the platform 305, as shown. Figure 19B shown.

[0177] like Figure 20A and Figure 20B As shown, device 412 can have a shaft 404 and a platform 405 having a front end 406 and a rear end 407. Platform 405 can have similar features to any of platforms 5, 105, 205, 305. Sleeve 418 is configured to slidably move on shaft 404. Sleeve 418 can include an extension member 417 that is configured to push tissue down onto blades 410, 411 of platform 405 to cut or shear the tissue. Extension member 417 can be sized and shaped to fit between blades 410, 411 to extend the sleeve 418 as sleeve 418 moves to the position indicated. Figure 20A411. When the device 412 is in the closed position shown, the extension member 417 can be configured to improve the cutting of tissue. For example, the extension member 417 can be a short finger-like member configured to push tissue downwardly onto the blades 410, 411 as the device 412 is moved through the tissue site. As another example, the extension member 417 can be sized and shaped (e.g., a long finger-like member) to grasp tissue or objects between the extension member 417 and the front portion of the platform 405.

[0178] The device 112, 212, 312, 412 can be configured with a shaft 104, 204, 304, 404 and a sleeve 118, 218, 318, 418 having any desired shape. For example, the shaft 104, 204, 304, 404 can be cylindrical (e.g., circular in cross-section), and the sleeve 118, 218, 318, 418 can be similarly shaped to match. In aspects of the present disclosure, the shaft 104, 204, 304, 404 and the sleeve 118, 218, 318, 418 can be elliptical, oval, etc. The sleeve 118, 218, 318, 418 can be sized and shaped to match the shaft 104, 204, 304, 404. For example, the sleeve 118, 218, 318, 418 can be shaped to fit only around the shaft 104, 204, 304, 404 (e.g., a form fit). The form fit sleeve 118, 218, 318, 418 can have no fluid flow passage between the shaft 104, 204, 304, 404 and the sleeve 118, 218, 318, 418. In another example, the sleeve 118, 218, 318, 418 can have a different shape than the shaft 104, 204, 304, 404, such as a round shaft 104, 204, 304, 404 and an oval sleeve 118, 218, 318, 418. The sleeve 118, 218, 318, 418 can be formed from one or more rigid or substantially rigid materials, such as metal.

[0179] like Figure 22 As shown, a device 512 having a sleeve 518 can be used to aspirate biological material (e.g., blood, tissue) from the eye. Here, an irrigation fluid can flow through the sleeve 518 and out through one or more ports 538. Aspiration can be provided by drawing the biological material back into the hollow portion (e.g., lumen) of the shaft 504 by suction. The sleeve 518 can be made of any desired material (e.g., silicone).

[0180] like Figure 23As shown, the shaft 504 can have an engagement member 539 configured to prevent the sleeve 518 from sliding further on the shaft 504. For example, the engagement member 539 can protrude outward from the shaft 504, wherein the engagement member 539 can be a pin, a disk, a ridge, etc. The engagement member 539 can be retractable such that when in the engaged position, the engagement member 539 can prevent the sleeve 518 from sliding further on the shaft 504, and when in the retracted position, the engagement member 539 can allow the sleeve 518 to slide further on the shaft 504.

[0181] In one or more embodiments, any of the devices 112, 212, 312, 412 can be disposed within a sleeve 518. For example, the sleeve 118, 218, 318, 418 can be a rigid metal cannula, and the sleeve 518 can be a flexible silicone sleeve disposed over the rigid metal sleeve 118, 218, 318, 418, and having an opening at one end of the sleeve 518 from which the platform 5, 105, 205, 305 can extend. As an example, the sleeve 518 can provide a fluid circuit configured to provide fluid outflow from the port 538, wherein fluid flows in the space between the sleeve 518 and the sleeve 118, 218, 318, 418, and fluid and / or tissue flows back through the device 112, 212, 312, 412.

[0182] III. Construction Materials

[0183] This is not meant to limit embodiments of the present invention to any particular construction material; however, 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 silicon or another polymer or hydrogel.

[0184] In some embodiments, the blades contemplated herein can be made of a material that is transparent to optical coherence tomography (OCT) wavelengths (e.g., nm is typically 800-1600 nm). In one embodiment, OCT transparent materials include, but are not limited to, glycol-modified polyethylene terephthalate, polyvinyl chloride, polymethyl methacrylate, or polyphenylsulfone. While it is not necessary to understand the mechanism of the invention, it is believed that these materials allow intraoperative OCT to be performed during intraocular surgery without any visual interference from the ophthalmic knife.

[0185] In one embodiment, the device is made of the metal alloy material described in Furst, JG et al., “Metal Alloys for Medical Devices,” U.S. Patent 7,648,591

[40] , and Richter, K., “Amorphous Metal Alloy Medical Devices,” U.S. Patent 7,955,387

[41] , the entire contents of which are incorporated herein by reference. In one embodiment, the device of the present invention is made of a shape memory polymer material, which is selected from Reimink, MS and Ogle, MF, “Medical Devices with Polymer / Inorganic Substrate Composites”, U.S. Patent 7,604,663

[42] , Langer, RS and Lendlein, a., “Shape Memory Styrene Copolymers”, U.S. Patent 6,388,043

[43] , Langer, RS and Lendlein, a., “Shape Memory Polymers”, U.S. Patent 6,720,402

[44] , Tong, KCB et al., “Shape Memory Styrene Copolymer”, U.S. Patent 6,759,481

[45] , Stapper, KCB et al., “Variable Stiffness Medical Devices”, U.S. Patent 6,760,663

[46] Devices), U.S. Patent 7632,303

[46] , Anthamatten, ML and Li, J., “Shape Memory Polymers”, U.S. Patent 7935,131

[47] and Berger, EJ et al., “Methods of Forming a Part Using Shape Memory Polymers”, U.S. Patent 8038,923

[48] , all of which are incorporated herein by reference. In some embodiments, the device of the present invention is rigid at room temperature but more flexible at body temperature. In some embodiments, portions of the device of the present invention 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 various stiffnesses. In one embodiment, the shaft is flexible.

[0186] In some embodiments, the shaft is made of a low density material.

[0187] This is not meant to limit embodiments of the present invention to any particular material of construction; however, it is believed that preferred materials 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.

[0188] In some embodiments, portions of the device of the present invention 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 varying stiffness. In one embodiment, the tool shaft 3 is flexible. In some embodiments, the shaft is made of a low-density material.

[0189] C. Methods of using a multi-blade ophthalmic knife

[0190] In one embodiment, the present invention contemplates a method of 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 forceps ophthalmic knife, a clamping 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) cutting a strip of tissue from the target site.

[0191] Detailed differences between devices

[0192] Embodiments of the present invention are not limited to any particular method, medical goal, or device identification; however, it is believed that the device can be optimally designed to remove the trabecular meshwork of the eye, remove the covering of small blood vessels (such as veins, arteries, lymphatic vessels, or other vessels with a lumen), and be used to create a hole or opening in the eardrum of the ear. This is not intended to limit embodiments of the present invention to any particular mechanism; however, it is believed that creating an opening in the eardrum of the ear may be helpful in treating ear diseases.

[0193] This is not meant to limit embodiments of the present invention to any particular endoscope, and it is believed that the device may be optimally designed for use with ophthalmic endoscopy system endoscopes. One such system is commercially known as "Endo Optiks".

[0194] Thus, the specific composition and configuration of a multi-blade cutting system has been disclosed. However, it will be apparent to those skilled in the art that many more modifications besides those described may be made without departing from the inventive concepts herein.

[0195] All disclosures mentioned herein are incorporated herein by reference to disclose and describe the methods and / or materials associated with the disclosures cited. The disclosures discussed herein are only disclosed prior to the filing date of this application. Anything herein should not be construed as admitting that the present invention is not entitled to be published in advance by virtue of prior inventions. In addition, the publication date provided may be different from the actual publication date, which may require separate confirmation.

[0196] Experimental

[0197] Preclinical studies

[49] were conducted with approval for the use of human materials from the Colorado Multiple Institutional Review Board before the start of the study and adhered to the principles of the Declaration of Helsinki. Informed consent was obtained from donors or relatives for the use of human eye banks in research.

[0198] Example 1

[0199] Histological analysis

[0200] Six (6) 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 specimens were removed from storage medium and mounted on a platform with the TM side facing up and secured in place using tissue pins. A total of 2 specimens were used for each of the 3 treatments studied. The central TM was incised along the length of both limbuses under microscopic visualization using an MVR blade. For The device is inserted into Schlemm's canal under microscope visualization. Once in place, continuous ablation is performed using the foot pedal while slowly advancing the tip through the extent of the TM sample. A standard power setting of 0.8W is used during treatment. The TM of two samples is incised using the dual-blade device. The tip of the blade is used to incise the TM in a manner similar to that used for goniotomy, and then the blade is advanced in a clockwise manner along the extent of the TM. At the distal end, the blade tip is angled upward to incise the entire TM band, and the process is repeated in a counterclockwise manner to incise the remaining TM tissue.

[0201] All tissue samples were immediately stored in 4% paraformaldehyde / phosphate buffered saline at 4°C overnight and then cut into quarters radially. Rim sections were processed for histology and embedded in paraffin wax so that the cut edge of the tissue faced the front of the block. Tissue sections (6 mm thick) were cut and stained with Mayer's hematoxylin-eosin Y (Richard-Allan Scientific, Kalamazoo, Michigan, USA). Brightfield 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 CFI 103 / Plan Fluor objective.

[0202] Example II

[0203] Human eye perfusion

[0204] A total of 12 human eyeballs from intraocular lens donors without a history of glaucoma were obtained from various eye banks across the country for the perfusion study of each device. The perfusion system uses a standard programmable syringe pump (Pump 11 Plus; Harvard Apparatus, Holliston, Massachusetts, USA). Via an online real-time pressure sensor (research-grade pressure sensor; Harvard Apparatus), it is connected to a single-channel chart recorder (Pharmacia REC-481; Pharmacia / Pfizer New York, New York, USA). An internal diameter of 1.14 mm polyethylene tubing (PE-160; Warner Instruments, Hamden, Connecticut, USA) was used for all connections.

[0205] In each case, the human eyeball was first prepared by injecting Dulbecco's modified Eagle's medium (DMEM; Invitrogen / Life Technologies, Carlsbad, California, USA) through the optic nerve with a 26 Ga needle until the eyeball returned to a spherical shape. An infusion line (terminated by another 26 Ga needle) was inserted obliquely through the anterior chamber of the eye, passing through the cornea and pupil, and terminating at the end below the iris. The eyeball was wrapped with wet gauze and the infusion pump (filled with DMEM) was set to an initial inflow rate of 7 mL / min to increase the IOP until it reached 30 mmHg. The infusion rate was then reduced to 2-5 mL / min before the TM incision to maintain a steady-state IOP for at least 60 minutes. The preoperative IOP was measured immediately before the incision in each case. A three-bevel clear corneal incision was made near the limbus using a 1.7mm stainless steel keratome blade (BD), and the anterior chamber was filled with enough viscoelastic material (Healon GW Abbott Medical Optics, Abbott Park, Illinois, USA) to maintain the anterior chamber and provide sufficient visibility during the surgery in each case. Each technique was performed under the gonioscopic field of view using a standard direct gonioscopic lens under the assistance of a microscope. The surgical procedure for each device was as described above. In each case, treatment was approximately 100-180 ° of TM. For each device, treatment began at 180 ° angles to the corneal wound and extended in a clockwise angle. The device was then extended in a counterclockwise direction from the same starting point. Every effort was made to treat the maximum extent possible with each device.

[0206] In the traditional improved double blade device and In the case of symptomatic spondylosis, the instrument was rotated 180° after the initial pass to point the device tip in the direction of treatment. The IOP was allowed to stabilize before postoperative IOP measurement. Each of the three surgical techniques studied was performed in a total of four eyes.

[0207] Two limbal sections were analyzed for each device. Six micron thick tissue sections were taken from different clock times treated with each device and stained with Mayer's hematoxylin-eosin Y (Richard-Allan Scientific). The results were consistent across all sections of each test device. Cutting with the MVR blade showed a complete incision through the full thickness of the TM tissue. However, the removal of TM was minimal while retaining a large tissue lobule over Schlemm's canal. The incision was deep through Schlemm's canal with minimal removal of the adjacent deep sclera ( Figure 1 ) causing significant damage. Access to Schlemm's canal was also achieved through the entire TM tissue. Although the device also removed a large portion of the central TM, a large number of lobules of residual tissue remained. The residual TM showed extensive charring caused by thermal damage. Tissue debris was also noted to block the distal collector channel ( Figure 2 Tissue cut with the dual blade device showed more complete TM removal without collateral damage ( Figure 3 ).

[0208] Data from human eye perfusion studies are included in Table 1. The range of TM treatment varied from 100 to 180° between devices and between eyes. 30 minutes after treatment, IOP measured by all 3 treatment modalities was significantly lower. Treatment resulted in a mean IOP reduction of 40%, while MVR blade treatment achieved a 31% reduction. The percentage of IOP reduction was higher with the dual-blade and double-blade devices, but there was no statistically significant difference in IOP reduction between the two devices (dual-blade / MVR P = 0.13; dual-blade / P = .96; There was no correlation between the extent of TM treatment and the percent IOP change by any device (r2 = 0.077-0.271).

[0209] Table 1. Human eye perfusion studies after trabecular meshwork treatment with various conventional devices

[0210]

[0211]

[0212] IOP = intraocular pressure; MVR = microvitreoretinal.

[0213] In this study, an embodiment of the present invention, a dual-blade device for the treatment of glaucoma, was evaluated in a preliminary preclinical setting

[49] . Histological analysis of human cadaver tissue treated with the dual-blade device demonstrated that more complete removal of TM tissue was achieved without causing any detectable damage to surrounding tissue. Treatments using other TM removal methods, such as The MVR blade goniotomy and visco-endoscopic trabeculectomy with the device failed to achieve the same histologic results as the newer dual-blade device. Although the histologic data were obtained from the ex vivo processed limbus, similar results were observed when irrigated eyes were treated using the visco-endoscopic approach. The virtual absence of a TM leaflet with the dual-blade device may be beneficial in reducing the potential for future physical obstruction, and the reduced tissue damage may also reduce inflammatory responses or subsequent fibrosis at the surgical site.

[0214] In addition to potentially favorable histological outcomes, the dual-blade device resulted in significant IOP reduction in the human eye perfusion model. Although all three devices used in the perfusion model produced similar immediate IOP reductions, it is unclear how the use of the dual-blade device of the present invention more completely translates the removal of TM tissue and reduced collateral damage into long-term surgical outcomes when used to treat glaucoma. There was no correlation between the extent of TM treatment and IOP reduction. IOP reduction may be more dependent on the number of downstream collector channels exposed than simply the absolute amount of TM removed.

[0215] To provide a low-cost MIGS device that can be widely used by ophthalmologists, one embodiment of the present invention designs a novel medical-grade stainless steel double-blade device that can successfully remove TM without significant collateral damage. In one embodiment, the device includes a unique double-edge blade design that uses precise geometry to allow for more complete removal of TM tissue ( Figure 4A and Figure 4B ). While it is not necessary to understand the mechanism of the invention, it is believed that the procedure is performed from a visco-endo approach and is viscoelastic to maintain the anterior chamber. For example, the size and tip of the blade can allow for smooth entry into Schlemm's canal, similar to that used for traditional goniotomy procedures. Once in place, the tip is advanced through Schlemm's canal and the TM is elevated along a designed ramp that will guide the tissue toward a set of specially positioned blades to cut and remove the TM. The TM is juxtaposed between the outer wall of Schlemm's canal and the inner wall of Schlemm's canal to provide protection during cauterization. Compared to a backing plate, the dual-blade device transects the TM and elevates the TM to the outer wall of Schlemm's canal. Although it is not necessary to understand the mechanism of the invention, it is believed that by elevating the TM along the ramp of the device as it moves forward, tissue removal is maximized while the dual-blade cuts in a superior position and at a strategic angle. It is further believed that the angle between the distal cutting edge and the handle is designed to allow for maximum angle treatment through a single incision while avoiding damage to the overlying cornea or underlying scleral bone. The excised TM can be removed from the eye with forceps or, if combined with cataract extraction, aspiration can be performed during the irrigation / aspiration phase. In addition, the device of the present invention can easily pass through clear corneal incisions as small as 1.2 mm, thereby eliminating the need for additional incisions when combined with phacoemulsification.

[0216] Example III

[0217] Traditional incision goniotomy

[0218] The surgery begins with an incision in the trabecular meshwork that extends into the sclera with a larger section of the trabecular meshwork. For this surgery (considered the gold standard procedure for "cutting" the trabecular meshwork, traditionally called a "goniotomy"), an MVR blade is used to cut the trabecular meshwork to form an opening into Schlemm's canal. Histological samples were provided from the surgery, in which the incision was made through the trabecular meshwork and extended into the sclera. On both sides of the incision, there are leaflets of the larger trabecular meshwork remaining. These leaflets leave scars and close the opening into Schlemm's canal. This indicates that lowering intraocular pressure, and thus any long-term benefit, is the goal of the surgery.

[0219] Example IV

[0220] Operation

[0221] For this procedure (which is intended to replace goniotomy and improve upon it by removing segments of the trabecular meshwork), The device is used to engage and apply cautery to the trabecular meshwork. The circle represents the area where a small segment of the trabecular meshwork was removed; however, there are still remnants of larger lobules of trabecular meshwork and charred tissue on both sides of the treated area. Post-treatment images revealed residual trabecular meshwork and charred tissue. Tissue fragments blocked the collector channel. The device "burned" the tissue, and this burning of the tissue caused inflammation, leading to further scarring and, consequently, failure of the surgically induced ostium into Schlemm's canal. Furthermore, the cauterization process caused numerous bubbles to form during the procedure, making visualization difficult during the actual procedure. These issues are eliminated with the device of the present invention, a major advantage.

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Claims

1. A double-blade ophthalmic knife, comprising: handle; a shaft connected to the handle; as well as a platform connected to the shaft, a front portion of the platform extending radially outward from the shaft, wherein the platform comprises: First blade; Second blade; a blade tip at a forward end of the forward portion of the platform; an extension member extending from a rear end of the platform opposite a front end of the front portion of the platform and extending radially outward from the shaft, wherein the extension member is configured as a grabbing feature; and A movable sleeve is configured to slidably move along the shaft and grasp tissue between the sleeve and the grasping feature.

2. The ophthalmic knife according to claim 1, wherein: The grasping features are pincers.

3. The ophthalmic knife according to claim 1, wherein: The grasping features are tweezers.

4. The ophthalmic knife according to claim 1, wherein The grab feature includes a spring that is biased to close the grab feature.

5. The ophthalmic knife according to claim 1, wherein: The blade tip is a retractable blade tip.

6. The ophthalmic knife according to claim 1, wherein: The first and second blades are attached to first and second lateral sides of the platform, respectively.

7. The ophthalmic knife according to claim 1, wherein: The platform includes a slope that increases in depth extending from the blade tip to the rear end.

8. The ophthalmic knife according to claim 1, wherein: The platform also includes a first annular cutting edge.

9. The ophthalmic knife according to claim 1, wherein: The width of the platform is between 0.2 and 0.3 mm.

10. The ophthalmic knife according to claim 1, wherein The shaft is a telescopic shaft.

11. The ophthalmic knife according to claim 1, wherein: The sleeve is configured to overcome the biasing force of the capture feature by engaging at least a portion of the capture feature when the sleeve is moved in a direction along the axis.

12. The ophthalmic knife according to claim 11, wherein: The handle includes an actuation member coupled to the sleeve, the actuation member being configured to move the sleeve.

13. The ophthalmic knife according to claim 1, wherein At least a portion of the grasping feature includes a sharpened surface configured to cut tissue.

14. The ophthalmic knife according to claim 1, wherein The platform also includes a laterally concave bottom surface.

15. The ophthalmic knife according to claim 1, wherein The handle includes an actuation member configured to cause the grab feature to close.

16. The ophthalmic knife according to claim 1, wherein The handle includes an actuation member configured to cause the grab feature to open.

Images