Patent Application
20250143925
Anatomically, the human eye is divided into two distinct regions: the anterior segment and the posterior segment. The anterior segment includes the lens and extends from the outermost layer of the cornea to the posterior of the lens capsule. The posterior segment of the eye includes the anterior hyaloid membrane and all of the ocular structures behind it, such as the vitreous humor, retina, choroid, and the optic nerve.
Vitreoretinal surgery is performed within the posterior segment of the human eye to treat serious conditions including, but not limited to, age-related macular degeneration (AMD), diabetic retinopathy, diabetic vitreous hemorrhage, macular holes, retinal detachment, epiretinal membrane, diabetic retinopathy, and cytomegalovirus retinitis. Such procedures frequently require the severance and removal of portions of the vitreous humor from the posterior segment of the eye, which is a colorless, gel-like substance made of water, collagen and hyaluronic acid.
Vitreoretinal surgery may require incisions and insertion of surgical instruments within an eye to remove the vitreous and/or repair the retina. The vitreous and the retina are connected via small microscopic fibrils of vitreous that are attached to the retina and, therefore, removal of the vitreous must be done with great care to avoid disturbing the retina. If the vitreous is disturbed during the surgery or incorrectly/inadvertently manipulated, the retina may be subject to unwanted traction causing separation of the retina from the choroid in the back of the eye, a retinal tear, or removal of the retina itself with the vitreous.
There have been improvements in the art, such as increased vitreous cutting speeds, that have improved the amount of traction produced in vitreoretinal surgery; however, the incidence rate of retinal tears is still high. Therefore, improved instruments and techniques for preventing retinal tears and other retinal damage during vitreoretinal surgery are desirable.
Aspects of the present disclosure relate to instruments for ophthalmic (eye) procedures, and more specifically, surgical instruments for vitreoretinal surgical procedures.
In certain embodiments, a surgical instrument for ophthalmic procedures is provided. The surgical instrument includes a handle comprising a distal end and a probe comprising a proximal end coupled to the distal end of the handle and a micro-structure patterned on an interior or exterior (or both) surface of the probe.
In certain embodiments, a surgical instrument includes a handle comprising a distal end, and a probe comprising a proximal end coupled to the distal end of the handle and a driver in communication with the probe. The driver is configured to cause vibration of the probe.
In certain other embodiments, a surgical instrument includes a handle comprising a distal end, and a probe comprising a proximal end coupled to the distal end of the handle and a coating on the distal end of the probe. The coating may be on the interior or exterior (or both) surface of the distal end of the probe. The coating is configured to reduce adhesion to a vitreous of an eye.
The drawings described herein are for illustrative purposes only, are schematic in nature, and are intended to be exemplary rather than to limit the scope of the disclosure.
The above summary is not intended to represent every possible embodiment or every aspect of the subject disclosure. Rather the foregoing summary is intended to exemplify some of the novel aspects and features disclosed herein. The above features and advantages, and other features and advantages of the subject disclosure, will be readily apparent from the following detailed description of representative embodiments and modes for carrying out the subject disclosure when taken in connection with the accompanying drawings and the appended claims.
Aspects of the present disclosure relate to ophthalmic procedures, and more particularly, to instruments for use during ophthalmic procedures.
In some embodiments, the base 120 is a hand piece having an outer surface configured to be held by a user, such as a surgeon. For example, the base 120 may be ergonomically contoured to substantially fit the hand of the user. In some embodiments, the outer surface may be textured and/or have one or more gripping features formed thereon, such as one or more grooves and/or ridges. The base 120 may be made from any materials commonly used for such instruments and suitable for ophthalmic surgery. For example, the base 120 may be formed of a lightweight aluminum, a polymer, or other suitable material. In some embodiments, the base 120 may be sterilized and used in more than one surgical procedure, or it may be a single-use device.
The base 120 further provides one or more ports 123 (e.g., one port is depicted in
The probe 110 extends from the distal end of the base unit 120 and may have an outer surface configured to interface with the external environment (e.g., vitreous within a patient's eye). The probe 110 may be made of any materials commonly used for such instruments and suitable for ophthalmic surgery. For example, the probe 110 may be formed of a lightweight aluminum, a polymer, or other suitable material. In some embodiments, the probe 110 may be sterilized and used in more than one surgical procedure, or it may be a single-use device.
While the embodiments described herein generally refer to a surgical instrument as shown in
Vibration of the probe 210 prevents vitreous fibrils in the eye from adhering to the probe 210 as the probe 210 enters a patient's eye. In order to prevent adhesion of vitreous fibrils, the surgical instrument 200 may vibrate (e.g., oscillate, pulsate, etc.) at a high-frequency, low-amplitude vibration. For example, the surgical instrument 200 may vibrate at a frequency between 1 kHz (kilohertz)-1 MHz (megahertz), such as between 1-500 kHz, or between 1-250 kHz, or between 1-100 kHz, or between 1-100 MHz, or between 1-50 MHz, or between 50-100 MHz. Further, the surgical instrument 200 may vibrate at an amplitude between 1-500 micrometers, such as between 1-250 micrometers, or between 1-100 micrometers, or between 1-50 micrometers, or between 100-200 micrometers, or between 200-500 micrometers, for example. The high-frequency, low-amplitude vibration may be preferred as low-amplitude vibration causes little displacement within the eye, while high-frequency vibration provides sufficient velocity to overcome the friction of the vitreous with the surgical instrument 200. As described herein, reduction in adhesion of the vitreous may prevent retinal tears and other retinal damage that results from ophthalmic procedures, specifically vitreoretinal surgery.
In
In
In
For example, as shown in
As shown, the micro-structure 302 includes raised surfaces on the exterior surface of the probe 310, which may cover the entire length of the probe 310 or just a portion of the probe 310 (e.g., a portion of the probe that enters the eye of a patient). In some embodiments, the micro-structure 302 includes raised surfaces on the interior surface of the probe 310, which may cover the entire length of the probe 310 or just a portion of the probe 310 (e.g., a portion of the probe that enters the eye of a patient). As discussed relative to the probe in
The micro-structure 302 may be operable to create a non-adherent or low adherence interface between the probe 310 and the vitreous of the eye of the patient during surgery. In certain embodiments, the non-adherent interface may be hydrophobic. As shown, the micro-structure 302 comprises a diamond pattern of raised surfaces on the probe 310. However, the pattern may be any suitable pattern comprising raised surface area on the probe 310, such as a pattern of small “pillars” raised from the surface of the probe 310 in any suitable pattern, for example. The micro-structure may have a depth of 0.1 microns to 100 microns from the surface of the probe 310, such as a depth between 0.1 microns and 100 microns, such as between 0.1 microns and 50 microns, such as between 1 micron and 50 microns, such as between 1 micron and 10 microns.
In certain embodiments, the micro-structure 302 may be a nano-crystalline diamond material. The nano-crystalline diamond material may be created by growing millions of small diamond crystals to be placed on the surface of the probe 310. A nano-crystalline diamond material on the probe 310 may create a raised surface area on the interior or exterior surface of the probe 310 and create a low friction interface between the probe 310 and the vitreous fibrils.
In certain other embodiments, the micro-structure 302 may describe a polished or roughened surface of the probe 310. For example, the interior or exterior surface of the probe 310 may be polished using a physical polishing technique in order to lessen friction between the interior or exterior surface of the probe 310 and the eye of the patient (e.g., vitreous fibrils).
As shown, coating 404 may be a permanent or semi-permanent coating disposed on the exterior surface of the probe 410 to create a low-adherence or non-adherent interface with a vitreous of an eye of a patient. The coating may be configured to reduce adhesion to the vitreous of the eye of the patient. The reduction in adherence of the coating may be measured when compared to the adhesion of the material of the probe (e.g., lightweight aluminum, a polymer, or other suitable material) to the vitreous of the eye of the patient. In certain embodiments, the coating 404 may be hydrophobic. The coating 404 on the exterior surface of the probe 410 may be made of any material suitable to create a low-adherence, non-adherent, or hydrophobic interface with an eye of a patient. For example, the coating may be formed of polyvinyl chloride, polyurethane, polytetrafluoroethylene, epoxy resin, silicon, polysilicon (e.g., formed via a plasma deposition process), hydrophilic amine, sulfonate, multilayer polyelectrolyte, hydroxyl, amine (e.g., a polymer substrate having an amine incorporated into the polymer substrate), sulfonate, multilayer polyelectrolyte, polydimethyl siloxane, phospholipid bilayer, hyaluronic acid-based materials, carbon nanotubes, polytetrafluoroethylene, physical vapor deposition (PVD)-formed materials, ceramics, or other suitable materials. The coating 404 may have a thickness of 0.01 microns to 100 microns along the length of the probe 410.
In certain embodiments, the coating 404 may be applied to the probe 410 to create a micro-structure (e.g., micro-structure 302). For example, the coating 404 may create a micro-structure on the exterior surface of the probe 410. The micro-structure created by the coating 404 may be any suitable pattern to prevent adhesion of the vitreous to the probe 410.
In certain embodiments, the coating 404 may be a temporary coating. For example, the temporary coating may be formed of silicone oil, sodium chloride, perfluorocarbon liquid, or other suitable material. The temporary coating may be applied to the surgical instrument (e.g., surgical instrument 200 or surgical instrument 300) by the surgeon by dipping the probe of the surgical instrument into the temporary coating. Immediately following application of the temporary coating, the surgeon may then insert the surgical instrument directly into the eye of the patient.
In certain embodiments, the coating may be a coating that prevents adhesion by osmosis (e.g., an osmotic coating). In still other embodiments, the coating 404 may be a dry coating (e.g., a non-liquid material) applied to the probe to create the low-adherence, non-adherent, or hydrophobic interface with an eye of a patient.
As shown, coating 504 may be a permanent or semi-permanent coating disposed on the interior surface of the probe 510 (e.g., on the interior surface of wall 512) to create a low-adherence or non-adherent interface with a vitreous of an eye of a patient. The coating may be configured to reduce adhesion to the vitreous of the eye of the patient. The reduction in adherence of the coating may be measured when compared to the adhesion of the material of the probe (e.g., lightweight aluminum, a polymer, or other suitable material) to the vitreous of the eye of the patient. In certain embodiments, the coating 504 may be hydrophobic. The coating 504 on the interior surface of the probe 510 may be made of any material suitable to create a low-adherence, non-adherent, or hydrophobic interface with an eye of a patient. For example, the coating may be formed of polyvinyl chloride, polyurethane, polytetrafluoroethylene, epoxy resin, silicon, polysilicon (e.g., formed via a plasma deposition process), hydrophilic amine, sulfonate, multilayer polyelectrolyte, hydroxyl, amine (e.g., a polymer substrate having an amine incorporated into the polymer substrate), sulfonate, multilayer polyelectrolyte, polydimethyl siloxane, phospholipid bilayer, hyaluronic acid-based materials, carbon nanotubes, polytetrafluoroethylene, physical vapor deposition (PVD)-formed materials, ceramics, or other suitable materials. The coating 504 may have a thickness of 0.01 microns to 100 microns along the length of the probe 510.
In certain embodiments, the coating 504 may be applied to the probe 510 to create a micro-structure (e.g., micro-structure 302). For example, the coating 504 may create a micro-structure on the interior surface of the probe 510. The micro-structure created by the coating 504 may be any suitable pattern to prevent adhesion of the vitreous to the probe 510.
In certain embodiments, the coating 504 may be a temporary coating. For example, the temporary coating may be formed of silicone oil, sodium chloride, perfluorocarbon liquid, or other suitable material. The temporary coating may be applied to the surgical instrument (e.g., surgical instrument 200 or surgical instrument 300) by the surgeon by dipping the probe of the surgical instrument into the temporary coating. Immediately following application of the temporary coating, the surgeon may then insert the surgical instrument directly into the eye of the patient.
In certain embodiments, the coating may be a coating that prevents adhesion by osmosis (e.g., an osmotic coating). In still other embodiments, the coating 504 may be a dry coating (e.g., a non-liquid material) applied to the probe to create the low-adherence, non-adherent, or hydrophobic interface with an eye of a patient.
As shown, coating 504 may be a permanent or semi-permanent coating disposed on the interior surface of the probe 610 (e.g., on the interior surface of wall 612) to create a low-adherence or non-adherent interface with a vitreous of an eye of a patient and coating 404 may be a permanent or semi-permanent coating disposed on the exterior surface of the probe 610 (e.g., on the exterior surface of wall 612) to create a low-adherence or non-adherent interface with a vitreous of an eye of a patient. The coating(s) 404/504 may be configured to reduce adhesion to the vitreous of the eye of the patient. In some embodiments, coatings 404 and 504 may have the same material/configuration. In some embodiments, coatings 404 and 504 may be different (e.g., coating 404 may be made of polytetrafluoroethylene while coating 504 may be a ceramic. Other coating choices are also contemplated. In some embodiments, one of the coatings 404 or 504 may be applied (to an interior or exterior surface, respectively) and the other of the interior or exterior surface may have a micro-structure applied). Other combinations of coatings and micro-structures are also contemplated.
The above disclosed subject matter is to be considered illustrative, and not restrictive, and the appended claims are intended to cover all such modifications, enhancements, and other embodiments which fall within the true spirit and scope of the present disclosure. Thus, to the maximum extent allowed by law, the scope of the present disclosure is to be determined by the broadest permissible interpretation of the following claims and their equivalents, and shall not be restricted or limited by the foregoing detailed description.
| Number | Date | Country | |
|---|---|---|---|
| 63597092 | Nov 2023 | US |
