Medical ophthalmic device

Abstract

A tool including a handheld component having a flat, cannulated tip adapted to receive a flow from a pumping unit to generate a fluid jet suitable for procedures such as “water separation” of cells in the eye. According to an embodiment of the invention, the tool includes a visualization probe with at least one camera, wherein the sensor of the at least one camera is located distal to the tip of the tool for insertion into the eye for imaging from within the eye.

Description

Invention Field

[0001] This invention relates to the field of medical instruments. More specifically, this invention relates to a medical ophthalmic device for diagnostic, therapeutic, and surgical applications, suitable for various medical / surgical procedures in humans and / or animals. Background of the Invention

[0003] Miniaturization may be key to the successful execution of precision medical procedures such as surgery (i.e., high resolution), especially in complex organs like the eye. Furthermore, visualization within the human body is a well-established and indispensable tool for physicians to make accurate diagnoses of a wide range of diseases, deliver therapeutic agents and / or perform minimally invasive surgeries within the body, and to enable surgical techniques to limit the size of required incisions, thereby reducing wound healing time, associated pain and infection risks, and even reducing or eliminating the need for sutures.

[0004] Cataract surgery is one of the most common surgeries in the world. More than 4 million surgeries are performed in the United States alone, and it remains one of the leading causes of vision loss worldwide. To remove cataracts using modern technology, a tool called a phacoemulsifier was developed in the 1970s and has been improved over the past 40 years. This tool enters the eye through a tiny 2.5mm incision in the cornea and uses ultrasound to break up the cataract material, which is then aspirated from the eye. The cataract is supported in the eye by a very thin membrane called the lens capsule. It is opened with a circular tear of at least 5.5mm. The lens is slightly separated by injecting water under the limbus of the capsule to allow it to flow around the cataract. The lens is typically removed by cutting a notch in the middle and then splitting the lens in half or a quarter. A second instrument is then used to separate the lens through a small incision of 1.0 to 1.5 millimeters. Once the lens nucleus or the denser portion of the lens is removed, a smaller nozzle instrument is used, employing suction to peel the softer portion of the cataract from the delicate lens capsule. These cells residing on the capsule surface are adherent and difficult to remove completely without damaging the capsule. Therefore, the cells are usually reduced, but not completely eliminated. Under the influence of the water droplet, the pupil dilates by 6-10 mm, and the lens size is typically 12-13 mm. Therefore, the lens material located under the iris is not easily visible. The surgeon can reach under the iris with a suction tool, but this procedure is risky because the capsule will be trapped in the vacuum tip and may be damaged or torn. Once the capsule appears clear, this "bag" is filled with a gel called viscoelastic material, and a 6 mm implant is squeezed into the eye through a 2.5 mm incision. At this point, the gel is removed again using an I / A tool, as the gel dissolves within 24 hours after surgery, causing increased intraocular pressure. The gel is transparent and difficult to see. It will attach to the back of the lens and remain in the outer part of the capsule, close to the inside of the cornea. Residual lens cells, known as lens epithelial complex cells or LEC, can be removed with some effort using a scraping tool or a round, rough ball called an olive tip. Despite these efforts, more than half of the eyes will develop secondary cataracts in the first few months to years after surgery.

[0005] To address this problem that causes glare and loss of optimal vision, Israel developed a laser called the YAG laser. This is a destructive laser that opens the capsule behind the implant and the vitreous body, allowing the cells to float to the back of the eye. The IOL (intraocular lens) usually remains in place because it is held in place by an 11mm "arm" that extends into the capsule. Once this surgery is performed, vision usually improves, but patients may have "floaters" or fragments floating in the vitreous body. The incidence of retinal detachment and swelling of the visual center (called the macula) is reduced. IOLs are now less likely to be replaced because the vitreous body can now access the front of the eye. In modern times, we have developed IOLs that can give patients bifocal vision. These IOLs are not tolerated by all patients because they can cause halos and glare. This is the main cause of lens replacement in so-called postoperative glare. The clinical dilemma is that when patients retain their lens cells and this type of IOL, it is difficult to know whether treating or replacing the capsule will improve their vision. If the capsule is treated, IOL replacement becomes very difficult and requires a vitrectomy. This further increases the risk of an eccentric IOL or retinal swelling.

[0006] It has been noted that using a flat cannula and vigorously flushing the capsule with water can reduce the rate of retained cells. Cells invisible under the iris still cannot be detected. The object of this invention is to address this problem with a specially designed device that uses a miniature camera to improve intraocular visibility, allowing visualization of these cells and viscoelastic material for subsequent power-washing.

[0007] Glaucoma is the degeneration and loss of nerve fibers that are damaged when elevated intraocular pressure compresses the optic nerve in the back of the eye. These fibers are thought to be "squeezed" and enter a phase called apoptosis or programmed cell death. It is a leading cause of vision loss worldwide, and this tendency increases with age, rivaling the development of cataracts. The increased pressure is caused by the narrowing of the eye's outflow system and the blockage (backup) of the pressure-enhancing aqueous humor. Eye drops and lasers can be used, and in severe cases, an opening can be created to allow fluid to drain from under the conjunctiva. Over the past 15 years, devices have been developed to bypass the outflow tissue (called the trabecular meshwork). This is known as minimally invasive glaucoma surgery, or MIGS. There are various variations, but generally, during cataract surgery, the device is placed through the mesh or the mesh is peeled away to allow the aqueous humor to flow freely into a venous collector. Performing this procedure is challenging because the angle of the eye cannot be seen when looking directly down through a microscope. Therefore, a prism must be used while the patient's head is moved 45 degrees away from the viewing mirror, and then the microscope is tilted 45 degrees. A gel is placed on the cornea, and the field of view angle is captured. The insertion instrument is placed under the prism, and an attempt is made to use the device or peel it off through an incision across the eye. Because this tissue is connected to veins with surface pressure, blood often flows back into the eye, obstructing the field of view. This must be cleared with a viscoelastic material, and another attempt is made. The purpose of this tool is to provide a direct view without tilting the head or microscope, and because it can spray water and illuminate the field of view of the intended target, the field of view will remain clear because the spray system can remove any blood (if any).

[0008] One object of the present invention is to utilize a tool to improve surgical techniques for performing effective medical procedures, such as those described above, and numerous others in which visibility through a microscope is limited by opacity, iris, or blood, in order to reduce potential complications. One or more of the following features may be incorporated into the tool: a camera, a light source (including color), a laser source, a scraping tool, and irrigation (inflow and outflow), the irrigation including pulsation, aspiration, ultrasound, and injection of gas and / or drugs.

[0009] Another objective of this invention is to combine the “powerful cleaning” of cells and viscoelastic material of the lens capsule after cataract incision with the ability to swell the capsule, thereby improving the efficiency and safety of further removal of exfoliated cells that are hidden behind the iris or are not visible from a microscope but are easily visible from a camera angle. These exfoliated cells are sometimes color-enhanced to make them fluoresce, and these cells are lipids covered by the capsule (i.e., collagen).

[0010] Another object of the present invention is the use of controlled and targeted saline sprays in ophthalmic surgery, which can be used to open tissue planes, remove blood and debris, and remove viscoelastic substances remaining in gaps that are usually missed by suction tools.

[0011] Another object of the present invention is to provide visualization of the trabecular meshwork, ciliary sulcus, scleral venous sinus, ciliary body, and subiris region to assist in minimally invasive glaucoma surgery. Camera equipment may reduce bulky tools like prisms, thereby enabling visualization of tissues invisible to microscopes. Combined optical vision allows for lowering of intraocular pressure during delivery and placement of implants (stents), shunts, or any other devices, or allows for delivery of shunts.

[0012] Another object of the present invention is to provide a medical ophthalmic device capable of accurately delivering drugs under direct vision. This can be safely performed under direct internal observation. Needle insertion may be performed by a second hand using the needle. This video device allows for easy clamping or securing of pumps or medical devices that dissolve drugs over extended periods.

[0013] Another object of the present invention is to provide a medical ophthalmic device capable of delivering laser power under direct vision for use in glaucoma, repairing retinal tears, and burning blood vessels.

[0014] Another objective of this invention is to standardize the procedure by enabling the opening and stabilization of the anterior and posterior chambers with internal flow, which will increase the chances of successful surgery in ophthalmic procedures.

[0015] Another objective of this invention is to perform cataract surgery, glaucoma surgery and vitrectomy, lacrimal duct opening, ocular trauma and tumor surgery.

[0016] As the description proceeds, other objects and advantages of the invention will become apparent. Invention Overview

[0018] In a first aspect, the invention is a tool including a handheld component having a flat, tubular tip adapted to receive a flow from a pumping unit to generate a fluid jet adapted to “hydro-dissecting” cells in the eye.

[0019] According to embodiments of the invention, the tool is adapted to aspirate cortex or cells from the capsule beneath the incision, or to remove other debris / residues, such as viscoelastic material remaining in the crevices.

[0020] According to an embodiment of the present invention, the tool is a water separation miniature camera tool.

[0021] According to an embodiment of the invention, the tool further includes a channel configured to connect to an external suction unit to suction fluid at a rate suitable for jetting.

[0022] In embodiments of the tool, the received flow is controlled before reaching the flat, cannulated tip of the handpiece.

[0023] In embodiments of the tool, the flow is controlled by a processing unit based on input received from a control unit to allow variations in the flow toward the flattened cannulated tip, wherein the volume of the flow can vary according to the orifice diameter of the flattened cannulated tip, which affects the speed. The control unit may be a manual operating unit (e.g., a foot pedal), an automatic / autonomous control unit (e.g., potentially involving artificial intelligence), or any combination thereof.

[0024] In one embodiment of the tool, the flow can be pulsated at a variable rate adjustable by a control unit (e.g., by pressure applied to a foot pedal). As another example of this embodiment, various sensors combined with machine learning, artificial intelligence (AI), and programmable software can autonomously control and modify the flow of the water-separating endoscope tool. A database of program settings can be stored in a software package that allows users to personalize their preferences, each tailored to different stages of a specific surgical procedure.

[0025] In embodiments of the tool, the handpiece is designed to control flow when a suitable element (e.g., a valve or a start button) is pressed and released, resulting in a continuous flow at a lower or faster flow rate as pressure increases after blockage.

[0026] In embodiments of this tool, the flattened cannula-like tip is replaceable, allowing various tips to achieve higher fine dissection flow rates by narrowing the flattened tip, thereby enabling surgeons to use the slit width and amplitude best suited to their technique or procedure.

[0027] In embodiments of the tool, the opening of the slit can be straight or curved, elongated or narrow.

[0028] In embodiments of this tool, the redesigned phacoemulsification tip allows for low-level ultrasound in either jet mode without aspiration mode or both.

[0029] According to an embodiment of the invention, the tool further includes means for generating high-frequency pulsations to remove material adhering to a surface, particularly lens cells.

[0030] In embodiments of the tool, high-frequency pulsations are generated by a rapid ball valve within the pumping unit or handheld component.

[0031] In one embodiment of the tool, the quick-release ball valve is tension-bearing to allow for both faster and slower pulsations.

[0032] In one embodiment of the tool, the cannula-like tip of the handpiece includes a curved surface band behind the tip for pushing cells loose after they have been loosened by water separation on the swollen vesicle.

[0033] In embodiments of the tool, the ball valve system that opens using pressure within the handpiece can be controlled by a simple flow direction switch to select a continuous or pulsating flow through the same handpiece, or the handpiece can be a single handpiece with such continuous capability.

[0034] In embodiments of the tool, the flat, tubular tip is a two-handed tip with separate flow and suction.

[0035] In embodiments of the tool, the flat, cannulated tip is made of silicone or other soft synthetic material to allow for scraping and water separation from a softer tip.

[0036] According to an embodiment of the invention, the tool further includes a curved or straight band behind the tip for manually removing cells from the swollen capsule.

[0037] In one embodiment of the tool, the tip can be rotated to allow squeezing under the cut.

[0038] In one embodiment of the tool, the dual manual mode configuration can be used in conjunction with flushing and aspiration modes to allow for variable flow rates, wherein the dual manual mode is controlled by a redesigned phacoemulsification machine for enhancing the effectiveness of the dual manual mode by using a positive pressure pump to drive the flow to a tip with a matched outflow rate.

[0039] In one embodiment of the tool, the handpiece includes a roughened region behind the tip, which can be flattened to increase the surface area.

[0040] In embodiments of the tool, the tip may be made of a soft, flexible material, or of a hard plastic or metal material.

[0041] In embodiments of the tool, the tip may vary in width from about 0.5 mm to 1.8 mm, and the opening of the tip may vary from about 0.05 mm to 1 mm.

[0042] In one embodiment of the tool, the tip includes a sleeve for removing fluid from the eye at a rate of fluid injection. This is in contrast to current I / A tools.

[0043] According to one embodiment of the invention, the tool further includes a separate suction tip that can be used to remove debris and enhance the ability to aspirate cortex or cells from the capsule beneath the incision.

[0044] In embodiments of the tool, the handheld component includes a visualization probe to provide better visibility of the adhered cellular layer.

[0045] In embodiments of this tool, the visualization probe includes a video camera to visualize the capsule from the ejection angle.

[0046] In embodiments of the tool, the light source can be white or colored to induce reflection / absorption by stained and unstained cells, wherein the light source can be integrated into the handheld component, and / or the illumination can be provided from an external source.

[0047] In embodiments of this tool, the water separation tool is configured such that a dual-model arrangement allows suction and propulsion to work together, wherein the tip can be placed on a flushing suction device to allow for this dual-model arrangement. In this mode, the camera and jet nozzle can be on one handpiece, and the illumination and vacuum can be on the other handpiece. As those skilled in the art will understand, any combination of these functions can be implemented, for example, the camera and illumination can be located on one handpiece, while the jet nozzle and vacuum can be located on the other handpiece.

[0048] In one embodiment of this tool, a camera can be integrated into the tip of an I / A device designed for dual-mode operation, allowing it to perform flushing and aspiration followed by switching to water separation aspiration. In this configuration, the same instruments can be used for operation when they are optimally utilized, based on the surgeon's experience and needs.

[0049] In embodiments of the tool, the tip can be placed on any jetting tool, including I / A tools, phacoemulsification tips for cataracts, syringes, or IV flow devices that are raised to provide pressure.

[0050] According to embodiments of the invention, the tool further includes a staining device for cell recognition purposes, wherein the staining device is selected from the group consisting of illumination, staining materials, or combinations thereof. Fluorescence can be enhanced by a variety of staining agents, and autofluorescence can be observed to distinguish between lipid cell wall lens cells and capsule collagen.

[0051] According to an embodiment of the invention, the tool further includes a semi-flat surface with small holes to balance fluid outflow and inflow, remove lens cell material, fix and scrape the capsule, and scrape the capsule behind the soft scraping ridge.

[0052] According to one embodiment of the invention, the camera's axis may be made of deformable plastic, metal, polyamide, or a hinge that can be bent or rotated, for example to allow reorientation of 45 to 180 degrees, thereby allowing the probe to observe and treat the area below the incision without having to re-enter the eye from the opposite side.

[0053] According to an embodiment of the invention, the camera tip may be made of a flexible material (such as rubber, silicone, or hydrogel) and will have a transverse chord or line that can be shortened to achieve arbitrary rotation of the viewing angle without being pulled out of the eye. The tube may have one or more hinged "elbows" that can rotate 90 to 180 degrees.

[0054] According to an embodiment of the invention, the tool further includes a double-sided scraping tool (e.g., about 0.1 to 0.3 mm) that has suction behind a vacuum port (e.g., the vacuum port may be in the form of a slit, a hole, or a larger opening) on ​​the top side away from the scraping element to avoid capsule capture.

[0055] According to one embodiment of the invention, the tool further includes an attachment to which a grasping or cutting tool can be attached to allow observation of the tip from a visualization probe, thereby enabling the performance of tasks outside the field of vision due to the iris. These may be two-handed.

[0056] In a second aspect, the present invention is a medical ophthalmic device comprising at least one camera, wherein a sensor of the at least one camera is positioned distal to the tip of the camera for insertion into the eye for imaging from within the eye.

[0057] In embodiments of medical ophthalmic devices, the size of the device will be adjusted according to its intended use. Larger devices may be used for specific techniques, passing through the main incision. The device size will be determined by the required practicality. Larger chips can provide the higher resolution required for certain surgeries, while ordinary resolution will allow for multiple benefits through smaller incisions.

[0058] In embodiments of medical ophthalmic devices, the main body of the device is small enough to be inserted through a cannula used in vitrectomy.

[0059] In embodiments of the medical ophthalmic device, the device's diameter is adapted to enable minimally invasive surgery using surgical techniques that limit the required incision size, thereby reducing wound healing time, associated pain, and the risk of infection. Incision sizes of 3 mm or less have shown that, when properly constructed to provide a waterproof seal at the end of the procedure, the need for sutures is reduced or eliminated. Therefore, the medical device can be applied through incisions of 3 mm or less, providing safety and minimal refractive changes. All these embodiments will be able to be designed to provide full functionality based on surgical goals and needs.

[0060] In embodiments of medical ophthalmic devices, the diameter of the device is less than approximately 1.8 mm. However, the diameter of larger models of cameras with larger chips will be much less than 3.0 mm.

[0061] In embodiments of medical ophthalmic devices, a light source is incorporated into the device.

[0062] In embodiments of medical ophthalmic devices, the illumination source may be located on the distal side of the device (i.e., at the tip) or the proximal side (i.e., in the handheld component).

[0063] In embodiments of medical ophthalmic devices, the distal illumination source is at least one light-emitting diode (LED).

[0064] In embodiments of medical ophthalmic devices, light reaches the distal end of the endoscope via optical fibers and / or light guides.

[0065] In an embodiment of the medical ophthalmic device, a phacoemulsification tool is integrated into the device. A camera can be attached to the phacoemulsification tip to allow for internal observation from that tip, which has been determined to be effective.

[0066] According to embodiments of the invention, the medical ophthalmic device also includes tools for removing lens cells under direct vision. This can be used, for example, in cases where corneal swelling or blood staining causes corneal visual impairment.

[0067] In embodiments of medical ophthalmic devices, the tool for removing lens cells under direct vision is an irrigation tool, a suction tool, or a combination thereof.

[0068] In embodiments of medical ophthalmic devices, irrigation and aspiration are integrated concentrically, i.e., one in the inner circle and one in the outer circle, or they are adjacent but located at the same tip. For example, these can be switchable to allow switching between jet or vacuum depending on the surgeon's goals and experience.

[0069] In embodiments of medical ophthalmic devices, the shape of the flushing port is shaped to control pressure.

[0070] In one embodiment of the medical ophthalmic device, the camera is attached to tweezers and scissors.

[0071] In one embodiment of a medical ophthalmic device, a camera is attached to a cannula that is manually operated to provide a water jet.

[0072] In an embodiment of a medical ophthalmic device, a laser device is incorporated into the multipurpose ophthalmic surgical device.

[0073] In embodiments of medical ophthalmic devices, an external lighting source is adapted to provide illumination according to the orientation of the device / camera.

[0074] In embodiments of medical ophthalmic devices, the endoscope's tube or tip is made of a transparent polymer material, thus allowing it to function as a light guide generated by an illumination source.

[0075] In embodiments of medical ophthalmic devices, the wavelength of light can be varied. Brief description of the attached diagram

[0077] In the attached diagram:

[0078] Figure 1A A perspective view of the head section of a water separation camera tool according to an embodiment of the present invention is shown schematically;

[0079] Figure 1B An embodiment of the invention is illustrated schematically. Figure 1A A top view of the head section of a water separation camera tool;

[0080] Figure 1C An embodiment of the invention is illustrated schematically. Figure 1A Side view of the head section of the water separation camera tool;

[0081] Figure 2 A perspective view of the head section of a water separation camera tool according to another embodiment of the present invention is shown schematically;

[0082] Figure 3A A schematic side view of a medical ophthalmic device with a light source (e.g., multiple LEDs, xenon arc lamps, etc.) located at the distal end of the device according to an embodiment of the present invention is shown.

[0083] Figure 3B A side view of a medical ophthalmic device with a light source according to an embodiment of the present invention is schematically shown, illustrating the position of an optical fiber located on the distal handpiece;

[0084] Figure 3C An embodiment of the invention is illustrated schematically. Figure 3A A cross-sectional view of the tip of a medical ophthalmic device;

[0085] Figure 4A A schematic side view of the tip of a medical ophthalmic device with a camera and LEDs according to an embodiment of the present invention is shown.

[0086] Figure 4B An embodiment of the invention is illustrated schematically. Figure 4A A cross-sectional view of the tip of a medical ophthalmic device;

[0087] Figure 5 A schematic side view of the tip of a medical ophthalmic device having a camera and an LED on the same PCB is shown in one embodiment according to an embodiment of the present invention;

[0088] Figure 6A schematic side view of the tip of a medical ophthalmic device according to an embodiment of the present invention is shown, the medical ophthalmic device having a camera and an LED behind the camera;

[0089] Figure 7 A cross-section of a medical ophthalmic device equipped with a laser, a camera, and an illuminator according to an embodiment of the present invention is shown schematically.

[0090] Figure 8 An elliptical tip of a medical ophthalmic device according to an embodiment of the present invention is illustrated schematically;

[0091] Figure 9 The dual manual mode is illustrated schematically;

[0092] Figure 10 A disposable tip with a reusable handpiece is illustrated schematically according to an embodiment of the present invention;

[0093] Figure 11 The distal tip of a medical ophthalmic device according to an embodiment of the present invention is schematically shown, the medical ophthalmic device being provided with an opening for rinsing or vacuuming;

[0094] Figure 12 An embodiment of the invention is illustrated schematically. Figure 11 The cross-section of the flushing tube of a medical ophthalmic device;

[0095] Figure 13 A schematic cross-section of the distal tip according to an embodiment of the invention is shown, illustrating an opening for flushing or vacuuming;

[0096] Figure 14 A medical ophthalmic device according to another embodiment of the present invention is schematically shown, the medical ophthalmic device being provided with a rinsing device and a camera sensor located at the tip of the device;

[0097] Figures 15A to 15B The illustration schematically depicts a medical ophthalmic device according to an embodiment of the present invention, the medical ophthalmic device having a plurality of LEDs and a camera located near the handheld device;

[0098] Figure 16 A cross-sectional view schematically illustrating another arrangement of a camera and a plurality of LEDs located at the proximal end of a handheld component of a medical ophthalmic device according to an embodiment of the present invention is shown.

[0099] Figure 17 A combined camera and a flushing probe, operating in parallel with a light probe within the human eye, are schematically illustrated according to an embodiment of the invention; and

[0100] Figure 18A medical ophthalmic device having various components according to an embodiment of the present invention is illustrated schematically.

[0101] Detailed description of the invention

[0102] On the one hand, the invention described herein expands the functionality of cannulation methods by providing surgeons with continuous / pulsating flow from the pumping unit and control over the forces from the fluid flow. The water separation tool (in any of its embodiments), will be simply referred to herein as the "tool".

[0103] Figures 1A to 1C The head section of a water separation tool 10 according to an embodiment of the present invention is schematically shown. The head section of the water separation tool 10 includes one or more vacuum ports 11, a soft and flexible wiping element 12, and a camera 13 located at the distal end of the tool 10. In this embodiment, the tool 10 has an elongated body suitable for use as a handheld device. In this embodiment, the vacuum ports 11 are located on the top side away from the element 12 to avoid membrane capture. In these figures, the vacuum ports 11 are provided in the form of orifices; however, other forms of vacuum ports or ports may also be employed, such as slit shapes or other forms of openings suitable for suction.

[0104] Figure 2 A perspective view of the head section of a water separation camera tool 20 according to another embodiment of the present invention is shown. The head section of the water separation camera tool 20 includes a water jet port 21, a soft and flexible wiping element 22, and a camera 23 located at the distal end of the tool 20. In this embodiment, the tool 20 also has an elongated body, thus enabling the tool 20 to be used as a handheld device. According to some embodiments of the present invention, the soft and flexible wiping element (e.g., as...) Figures 1A to 1C As shown by label 12 and as shown in Figure 2 The element shown in reference numeral 22 is optional, so the water separation camera tool may not include this element.

[0105] In one embodiment of the invention, the flow rate of fluid through the water jet port of the tool can be controlled by the width and angle of the tool (e.g., as shown in the figure). Figure 2(As shown regarding port 21). Furthermore, the water flow can be pulsating or continuous, depending on the surgeon's requirements. This flow can be guided by a pump, for example, from a cataract removal unit or vitrectomy unit. According to some embodiments of the invention, the tool may also have its own water source or pumping unit. The shape and cross-section of the outlet port of the fluid flow tip (e.g., water jet port 21) can vary. In ophthalmic surgery, if the outflow is too rapid or its cross-section is too narrow, it may tear the capsule of the eye. Furthermore, the pulsation rate and the flow rate per pulsation have a dynamic effect on the outflow width and height, as well as the outflow velocity. If the pulsation rate is too high, the outflow shock wave can tear the capsule. According to one embodiment of the invention, these limitations will be set in the device software flow software to limit the possibility of damage to the capsule.

[0106] According to embodiments of the present invention, a soft scraping tool made of any soft, flexible material (e.g., silicone) that is bent at the bottom and sides (e.g., respectively) Figures 1A to 1C and Figure 2 Elements 12 and 22 can be incorporated into the tool to loosen cells firmly adhered to the capsule membrane, and the cells can then be swept away by the reverse smearing motion of the scraping tool. According to an embodiment of the invention, the tool may include a curved or straight section behind the tip of the head section to allow gentle movement relative to the capsule membrane, thereby mechanically removing or loosening the cells, which are then removed by the tip.

[0107] In another aspect, the present invention relates to a medical ophthalmic device comprising a visualization probe having at least one camera (e.g., a video camera), wherein the sensor of the at least one camera is located at the tip of the tool to be inserted into the eye for imaging from within the eye.

[0108] The terminology used in literature relating to digital video cameras in general, especially those designed for endoscopic devices, lacks standardization. Here, unless specifically mentioned otherwise, the following terms will be used:

[0109] The terms “effective area,” “pixel / s area,” and “pixel array” are used interchangeably to refer to the light-receiving surface of an array of photosensitive elements (such as a photodiode) that converts incident light into electrons.

[0110] The terms “sensor,” “chip,” “solid-state image pickup device,” and “image pickup device” are used interchangeably to refer to: the effective area; an array of microlenses that focuses incident light onto a photodiode; in the case of a color sensor, an array of filters; and a silicon substrate on which the effective area is formed. When the sensor is manufactured using CMOS processes, these terms may also include electronics suitable for processing the output signal of the photodiode, implemented together with the array on silicon.

[0111] The term “solid-state imager” or simply “SSI” as used herein refers to any suitable solid-state image acquisition device (e.g., CMOS or CCD) that includes additional electronic circuitry to generate additional functions for processing signals on the same silicon or as an additional layer.

[0112] The term "camera" refers to the SSI and related optics required to focus light onto an effective area encapsulated in a single package.

[0113] The terms “video camera,” “camera,” and “miniature camera” are used interchangeably to refer to a standalone camera, or a camera with an attached electronic driver (if any).

[0114] The term "camera" specifically refers to a video camera.

[0115] According to one embodiment of the invention, miniaturization enables the acquisition of high-quality images (providing at least 30k pixels of quality relative to the image sensor of a camera, for illustrative purposes only), while the body of the device is small enough to be inserted through an incision formed around the cornea (e.g., during cataract and MIGS surgery). According to some embodiments of the invention, for illustrative purposes only, the outer diameter of the device is approximately 1.8 mm or less, thereby enabling minimally invasive surgery (i.e., enabling surgical techniques with limited incision size, thus reducing wound healing time, associated pain, and infection risk). The outer diameter of the device can vary depending on the size of the components / parts included in the device. For example, the resolution of the camera may affect the outer diameter of the camera, so a high-resolution camera may have a larger diameter than a low-resolution camera. Incision sizes smaller than 3 mm are self-sealing and result in negligible refractive errors, so a larger camera can be easily accommodated for all the functions of the tool, i.e., illumination and water separation and circling, depending on the surgeon's task and needs. The invention relates to a surgical device that provides an optical vision means by which several components within a single tool for microsurgery can be miniaturized. It can also be used in a two-handed mode, with functions split as needed.

[0116] According to another embodiment of the invention, all the features described herein can be incorporated into a single tool, wherein the surgery is performed through only one incision.

[0117] In the context of this application, the term "effective diameter" refers to the final diameter of the probe, regardless of its shape. Although the final shape of the probe will be circular in most cases, and although SSIs are typically square or rectangular in configuration, any other shape is possible, and the effective diameter can be equal to the longest cross-sectional dimension of the probe. Thus, for example, for a probe with a square cross-section, the effective diameter will be equal to the diagonal of the square, and the same parameter, with necessary modifications to the details, applies to rectangular, elliptical, or incompletely elliptical probes.

[0118] According to embodiments of the invention, the visualization probe includes electronic circuitry (or drivers) required to detail the signal generated by the SSI. In most cases, the advantage of using CMOS as the SSI compared to CCD lies in the ease and possibility of implementing several electronic circuits containing several important features or other digital processing features required to generate the image (e.g., correlated double sampling (CDS), A / D, gain, etc.). These circuits incorporate a pure sensor built from pixels, implemented using transistors within a single package. The implementation of these pixels can be based on two (three, four, five, six, or more) transistors per pixel, or by using shared transistors or other designs, such as 2T2S or 4T4S, or supplementing the pixels with a higher degree of shared transistors. Obviously, these circuits expand the package size, adding more pads. Furthermore, if a higher clock rate signal is used, it is recommended to use drivers containing amplifiers or regulators, several capacitors for noise reduction, and some resistors for signal matching. Such electronic circuitry (drivers) will increase space in the package or silicon, and therefore in most cases, it will be implemented outside the packaged CMOS or as an additional layer in the silicon construction.

[0119] If the CMOS sensor has a diagonal of less than 1.0 mm, the driver may contain a portion of the image processing features, such as a correlated double sampling (CDS) unit or other features required to generate the image, which are implemented within the packaged CMOS sensor itself and are then transferred externally to the driver or image processing unit. In this case, the CMOS sensor will only contain the minimum circuitry required to provide the signal and pump the raw signal from the CMOS. Furthermore, the driver will contain the minimum necessary components to match the clock signal required to activate the CMOS and output the signal to the video processing unit, which at this point contains all the circuitry and components required to process the raw signal and convert it into a video signal.

[0120] Thus, the CMOS sensor functions almost entirely as a pure imager that converts photons into electrons, and its size is extremely small. Since the driver also includes a very small number of components (one or two, sometimes even zero), this ensures that the overall size of the newly packaged CMOS video camera is extremely small. Another challenge to overcome is the number of pads associated with the CMOS design and the cables (including all the wires) used to provide signals to activate the CMOS and pump those signals to the video processing unit. In typical practice, multiple wires are used to provide these services.

[0121] Several technical solutions for minimizing the area of ​​an imager are described in U.S. Patent 8,803,960. For example, since there is insufficient space to accommodate so many pads in a solid-state imager with a diagonal of less than 1.0 mm, it is necessary to set a minimum number of pads (ideally one pad) to overcome this problem. By multiplexing multiple signals using the same pad, the entire SSI may use only four pads, sometimes three. Another way to minimize the area of ​​the imager is to use a current-based method instead of a voltage-based method to change the output video signal of the imager. This also stipulates that the external driver should include a matching stage circuit. The benefits of using this method include better filtering of amplification-related noise and the ability to transmit video signals over longer distances by using a modulator controlled by a video processor to compensate for video signal degradation. Another example of how the size of the SSI can be reduced is by providing a component with two functions (i.e., acquiring and transmitting images) on silicon. In addition to the aforementioned simplified technical solutions, compact configurations of CMOS chips with and without PCBs are disclosed in detail in WO2005 / 002210 and WO 2005 / 115221. Therefore, for the sake of brevity, the manufacturing of these components will not be discussed in detail here.

[0122] Reference will now be made to several embodiments of the present invention, which are illustrated in the accompanying drawings. The embodiments of the invention described herein are for illustrative purposes only. Those skilled in the art will readily recognize from the following description that alternative embodiments of the structures shown herein may be employed without departing from the principles of the invention as described herein.

[0123] According to embodiments of the present invention, visualization probes include cameras incorporated into medical ophthalmic devices. Fiber optic attachments to these tools can broaden their uses, effectiveness, and functional range. In some embodiments, optical fibers or LEDs can be used to transmit light of different colors and intensities to visualize the lens cells to be removed, for example, as... Figure 3A and Figure 3B As shown. Figure 3AA medical ophthalmic device 30 according to an embodiment of the present invention is schematically shown, having a light source 31 (e.g., multiple LEDs, a xenon arc lamp, etc.) located near the distal end of the device 30. For example, in the case where the light source 31 is one or more LEDs, reference numeral 32 indicates a line from a power supply or lighting control module connected to the proximal end of the device 30. Figure 3B A medical ophthalmic device 30 having a lighting source including LEDs and optical fibers is schematically illustrated according to an embodiment of the present invention. Figure 3B In this embodiment, device 30 includes element 33 for connecting the LED and optical fiber 34. Figure 3C An embodiment of the invention is illustrated schematically. Figure 3A A cross-sectional view of the tip of a medical ophthalmic device, showing the arrangement of four LEDs 31 surrounding the sensor 35 of the camera. Figure 7 A schematic cross-sectional view of the tip 70 of a medical ophthalmic device equipped with a laser fiber 71, a camera 72 and an illumination source 73 according to an embodiment of the present invention is shown. Figure 8 An elliptical tip 80 of a medical ophthalmic device according to an embodiment of the present invention is illustrated schematically.

[0124] In another embodiment of the invention, the light source can be: i) placed at the distal end of the tool, i.e., direct illumination; or ii) placed within the body of the tip, the tip including a light guide to the distal end; or iii) placed on the outer body of the tool, with an optical fiber guiding the light to the target area; or iv) placed by external light from a microscope, xenon lamp, xenon lamp / LED, or other illumination sources and beams placed outside the eye; or v) placed using additional illumination, such as an internal illuminator parallel to a camera inserted into the eye. Cells irradiated at different wavelengths will be stained differently, thus illumination is crucial for identification purposes. For example, at the end of cortical cleansing, cells can be stained with blue or other staining agents. A water separation tool equipped with a blue light source can then be used to irradiate adherent cells and remove them by water separation, scraping, or aspiration using separate tools. Other staining methods can also be used according to embodiments of the invention. For example, the tool can allow mixing with staining materials, such as 0.1% trypan blue, 0.001% gentian violet, or 0.5% indocyanine green (ICG). For example, the staining material can be mixed with saline and sprayed together. Effluent allows for the mixing of staining compounds. Compounds designed to reduce collagen turbidity in the capsule can be applied after all cell layers have been removed. By eliminating this currently perplexing problem of adherent cells, a better understanding of the natural history of collagen and how to induce it to remain clear will be achieved.

[0125] In another embodiment of the invention, a laser is incorporated into the tool to perform various optical processes, such as distance measurement, laser cutting, phototherapy, laser eye surgery, photoablation, etc. Furthermore, the wavelength of the laser can be varied according to the specific requirements of the task. Low-energy lasers may be helpful in identifying adherent cells without the need for staining compounds.

[0126] In another embodiment of the invention, an ultrasonic tool is incorporated into a device for emulsifying the lens.

[0127] Because the light source can be external, this tool is compatible with any externally connected light source. For example, see... Figure 3A and Figure 3B The ability to observe cells at the instrument's tip angle allows surgeons to remove cells in areas currently invisible to the naked eye from a microscope. Cross illumination from LEDs and colored optical fibers, combined with video observation, is key to this tool's capability. The angle and position of the video camera are unrestricted. Typically, the video camera can be 1.0 mm in size (or even smaller) and incorporates either a vacuum section or a jet component, or both, of a dual-mode system. The unit can have a slit opening for vacuum of 0.2 mm or larger, with a width of up to 1.8 mm. Figures 3A to 8 This illustrates several options for positioning the camera and light source, where the light source can be external and guided by light guides and / or optical fibers, or integrated into the distal end (i.e., internally) of the tip itself. For example, Figure 4A and Figure 4B An arrangement according to an embodiment of the invention is shown, wherein a light source 41 and a camera 42 are located at the tip 40 of a medical ophthalmic device. In this communication, the light source 41 is located on top of the camera 42. Figure 5 A side view of the tip 50 of a medical ophthalmic device having a camera 52 and an LED 51 on the same PCB 53 is schematically shown in one embodiment of the invention. Figure 6 A schematic side view of the tip 60 of a medical ophthalmic device according to an embodiment of the present invention is shown, the medical ophthalmic device having a camera 61 and an LED 62 behind the camera.

[0128] The light source itself may include, but is not limited to: microscope lamps, incandescent lamps, operating room lamps, light-emitting diodes (LEDs), fluorescent bulbs, xenon arc lamps, etc.; these lamps can be used individually or in combination. According to an embodiment of the invention, the light source is in the form of a light probe, adapted for insertion parallel to the device. Having different types of light sources is important because surgical procedures typically require specialized surgical illumination. Furthermore, light guides and optical fibers can facilitate illumination (see...). Figure 3A and Figure 3BFurthermore, the color of the light source is not limited to pure white light, but can include any color and / or wavelength that helps the user perform the process. According to embodiments of the invention, the removable / replaceable distal tip can include one or more LEDs with different wavelengths. For example, when using RGB LEDs, the color can be managed by software.

[0129] In one embodiment of the invention, the flow rate of fluid through the tool can be controlled by the width and angle of the tool. Furthermore, the water flow can be pulsating or continuous, depending on the surgeon's requirements. This flow can be directed by a pump from a cataract removal unit or a vitrectomy unit. The flow may also have its own source. The shape and cross-section of the outlet port of the fluid flow tip can vary. During eye surgery, if the outflow is too rapid or the cross-section is too narrow, the outflow may tear the capsule. Furthermore, the pulsation rate and the flow rate per pulsation have a dynamic effect on the width and height of the outflow and the velocity of the outflow. If the pulsation rate is too high, the shock wave of the outflow can tear the capsule. These energy limits are set in the pump's software to prevent the surgeon from exceeding these limits. See also Figures 11 to 13 Examples of embodiments of the invention are provided to illustrate this, in which fluid passes between an optical fiber and / or a camera positioned at the distal tip, and an opening defines the flow direction and pressure.

[0130] According to another embodiment of the invention, a soft scraping tool made of any soft, flexible material (e.g., silicone) that is curved at the bottom and sides can be incorporated into the device to loosen cells firmly adhered to the capsule membrane, and the cells can then be swept away by the reverse smearing motion of the scraping tool. The device may include a curved or straight section behind the tip to allow gentle movement relative to the stated capsule membrane, thereby mechanically removing or loosening the cells, which are then cleared by the tip.

[0131] In another embodiment of the invention, the tip may be angled to allow for the substitution of subcapsular angled surfaces, and the tip may be fitted into the outer cannula to allow inflow or outflow. Fluid through the tip flows at a rate proportional to the resistance / flow rate. If the flow rate remains constant, the resistance increases the pressure, causing the fluid to eject at a faster rate. In general, the object of the invention is to produce a flat or slightly curved fluid plane that encounters resistance as the fluid flows through the lens capsule. This resistance will be due to adherent cells and viscoelastic material remaining in the aqueous humor of the anterior and posterior chambers. Therefore, the shape of the tip is crucial to the design of this tool.

[0132] In another embodiment of the invention, in a dual-manual version, the jetting portion of the device can be separated from the suction or return portion. In this way, the size of the jetting portion can be reduced to allow it to be placed through a smaller cutout, such as in a side port or additional cutout. See also Figure 9 In the description of this embodiment, the dual manual mode is used with the camera, and the rinsing tool 91 is inserted into the eye 90 via a second incision, while the suction tool 92 is inserted into the eye 90 via a first incision.

[0133] In another embodiment of the invention, the aspiration portion of the unit can be combined with a light source, a camera, or an injection unit for placing the staining compound onto the capsule. The staining material can be used to visualize lens cells and residual viscoelastic material. Using colored light on the device will enhance the visibility of residual cells. Since this tool can be seen behind the iris, it can be equipped with an accessory for holding a grasping or cutting tool to operate where it is not visible under a microscope.

[0134] In another embodiment, the camera is integrated into the tool used for irrigation and aspiration. The camera and illuminator may be integrated only into the irrigation tool (bi-handed approach for cataract surgery). For illustrative purposes only, the irrigation channel can be any cross-sectional shape with a minimum diameter of 0.3 mm (e.g., several small tubes or free space between components in an outer tube). For example, the outer diameter can be approximately 1.5 mm. The tool can also be inserted through the main incision and / or secondary incision. Depending on the convenience of surgical practice, the tip can be permanent (reusable) or removable (disposable). See also Figure 10 The figure depicts a disposable tip 102 with a reusable handpiece 101.

[0135] Figure 11 A medical ophthalmic device 110 according to an embodiment of the present invention is schematically shown, which is provided with an opening 112 for rinsing or vacuuming. The medical ophthalmic device 110 includes a camera 111, an opening 112 for rinsing or vacuuming, and an illumination source 113. Figure 12 A schematic cross-section of the tip of a medical ophthalmic device 110 according to an embodiment of the present invention is shown, illustrating an irrigation tube 114. In this embodiment, water flows through the irrigation tube 114 and is sprayed via an opening 112. Figure 13 A schematic cross-section of the distal tip of a medical ophthalmic device according to another embodiment of the invention is shown, illustrating an opening 131 for rinsing or vacuuming, arranged around a camera 132 located at the center of the tip.

[0136] Figure 14A medical ophthalmic device 140 according to another embodiment of the present invention is schematically illustrated. Device 140 includes a flushing port 142, a tip 141, and a camera sensor (not shown) located on the tip 141. The flow rate can be controlled by a flow rate controller 143 located on the body 144 of the device's handheld component. In this embodiment, device 140 is controlled and powered via an operating unit (not shown), which is electrically connected to device 140 via a cable 145.

[0137] Figures 15A to 15B A medical ophthalmic device 150 according to an embodiment of the present invention is schematically shown, the medical ophthalmic device 150 having a plurality of LEDs 152 and a camera 151 located at the proximal end of a handheld device. Figure 16 A cross-sectional view schematically showing another arrangement of camera 161 and multiple LEDs 162 located near the proximal end of the handheld device is shown.

[0138] In another embodiment of the invention, the tip may be angled to compress the fluid sheet in a downward or upward direction. It may be angled to the surface of the membrane to apply minimal tension to the capsule while “stripping” away still-attached debris and lenticular cells. Therefore, the tip gap and width are critical to the functionality and safety of the device. Several variations in tip width and gap should be available, allowing the user to select the tip best suited to their experience and objectives. For illustrative purposes only, the tip width may be from 0.5 mm to 2.5 mm. For illustrative purposes only, the gap may vary from approximately 0.05 mm to 1 mm and may include curved or straight shapes. The tip may also have a roughened lower surface to allow cells to loosen from the surface behind the fluid jet. In this way, the capsule can be flattened in front of the roughened area to reduce the risk of the capsule rolling up or folding, then hooking and tearing. The roughened area may also be widened to allow the widened surface area to be cleared or loosened before the tip of the subsequent water separation cannula. In this way, the risk of impacting the fragile capsule is reduced.

[0139] In another embodiment of the invention, the tip material may be a metal with a combination of soft polymer elements to allow for gentle scraping.

[0140] Furthermore, the tip can achieve adjustable stiffness through piezoelectric elements, internal removable metal wires, the use of two tubes, an outer rigid tube, and a pre-formed semi-rigid or flexible inner tube. In this way, the tip can be rotated to provide different views from the camera and guide flow.

[0141] This invention enables the removal of lens fragments under direct vision. This can be accomplished by a combination of the following (but not limited to) components: a camera with flushing, a camera with suction, a camera with both flushing and suction, a camera with a phacoemulsification probe, a camera and features that allow for precise length rotation and positioning.

[0142] This invention enables glaucoma surgery. The camera eliminates the need for a gonioscope because it provides visualization of the ciliary sulcus and subiris space. In this use, the camera can be attached to a treatment device or a diagnostic observation device inserted through a second incision. The camera can also be placed parallel to the treatment device, such as a stent delivery tool, a shunt delivery tool, or the shunt itself. According to some embodiments of the invention, the camera can be integrated into the implant delivery tool.

[0143] This invention enables vitrectomy surgery in which a camera inserted into the eye can serve as a visualization tool when the anterior segment of the eye is opaque (e.g., an opaque cornea). In this embodiment, the camera is small enough to pass through the cannula used in the surgery and can aid in suture positioning and removal of foreign objects. For anterior surgeries, a curved tip can be used, while for vitreoretinal surgeries, a straight tip can be used.

[0144] A curved band, made of a flexible material such as silicone, can be placed behind the jet area. This can be used to impact tissue that has flattened in front of the effluent. Depending on the surgeon's preference for the task at hand, the curved area behind the tip can be made of a rigid material.

[0145] The curved tip can mimic the posterior curve of the capsule. The ideal angle for the tip used for water separation can be effectively parallel, or (for illustrative purposes only) an angle of 5 to 25 degrees or greater. This can be achieved by tilting an external instrument, or it can be built into a tip with a scraping element, whether it is made of silicone or a rough (e.g., diamond) or a rough synthetic or metallic surface.

[0146] Typically, the inflow of water is matched with the outflow from the side of the device or a "dual manual" technique. In dual manual mode, two tools are used for flushing and aspiration. In dual manual mode, two independent tools are inserted into two independent incisions and operate simultaneously. According to an embodiment of the invention, the tool may include flushing and aspiration through adjacent channels on the same tool, i.e., two separate tools are not required. In this embodiment, the operation of the flushing and aspiration device is reversed, flowing out from the tip and back along the side of the instrument. The tip can also be used as a tool to counteract the swollen capsule, which reduces the risk of the capsule rupture and tearing. Viscoelastic material can be completely drained from the back and front of the intraocular lens, or it can enter the iris sulcus and corneal dome.

[0147] In another embodiment of the invention, and in the dual-manual method, the inflow and outflow of water can also be controlled using the same tool. In this method, flushing and aspiration can be performed using a) two parallel tubes, or b) a coaxial method. The advantage of the two parallel tube method is that the tube inlet and outlet can be placed anywhere on the distal end of the probe, such as adjacent to or far apart from each other; while the coaxial method facilitates miniaturization, achieved by saving volumetric space along the probe itself and at the distal end of the probe. The coaxial method comprises concentric tubes, wherein the central tube flushes and the outer tube aspirates, or the central tube aspirates and the outer tube flushes. Both methods offer the advantages of miniaturization and integration into a single tool without requiring a second tool through a secondary incision.

[0148] The tip can also be used for sub-incision clearance by guiding flow from the lateral port or secondary incision. The more thoroughly the eye cells are removed, the less reaction is expected during the recovery phase.

[0149] Lens granules, cortex, and viscoelastic material are typically hidden beneath the iris. Reaching these areas with aspiration tools can damage the capsule, leading to zonular rupture or capsular rupture. Aggressive irrigation offers the advantage of safety and effectiveness over aspiration. Staining and illumination allow for visualization and confirmation of removal. Any residual lens material, even a thin layer of cells, especially nuclear material, can cause chronic or acute inflammation, resulting in slow recovery or macular swelling or macular cystoid edema. Therefore, complete removal of these cells for cataract removal predicts better postoperative outcomes.

[0150] In one embodiment of the invention, the device may be equipped with attachments beyond the camera, such as forceps or scissors, allowing surgeons the ability to perform tasks under direct vision. This could include suturing a capsular tension ring or a second IOL and releasing the IOL from its capsular attachment. A water jet system can maintain pressure and eliminate the need for viscoelastic materials in these procedures. The intraocular lens is centered by its arm or tactile element protruding into the capsular support area at the bandlet-capsular junction. How the IOL is positioned in this area is not currently visible. If so, the tactile element can be adjusted to be optimally positioned and most secure under direct vision. Furthermore, it facilitates a safer and more controlled procedure when the IOL must be removed to allow for separation of the tissue plane of the capsule folded over the tactile element. In some cases, the bandlet is fragile and may tear and loosen from its ciliary body attachment. In these cases, a ring can be placed in the capsular pouch to balance the stress around the damaged pouch. Direct visualization of the ring and the area requiring support will optimize its use in these situations. Sometimes sutures or a tactile "lasso" must be placed to attach it to the sclera. The procedure can then be optimized again under direct observation. In cases requiring two hands, the device can be stably positioned to observe the area of ​​interest while the surgeon sutures or ties knots with both hands.

[0151] In one embodiment of the invention, the fluid projection from the device tip can be shaped to allow safe water separation of lens cells from the lens capsule with a smaller required fluid volume. This can be controlled via a foot pedal or the handheld component itself. An example of this embodiment of the tool is shown in Figure 15, where various buttons, levers, and valves are shown integrated into the tool to control the flow rate and other parameters described herein. The flow rate can be adjusted according to the requirements of the task and the surgeon's judgment. Depending on the requirements of the task and the surgeon's judgment, the flow rate can be pulsating or continuous. Therefore, the frequency and intensity of the pulsation can also be set by the surgeon. For illustrative purposes only, the frequency of the pulsation can be a low rate of once per second or a high rate of 10 or more pulsations per second. Furthermore, the fluid flow rate and the pulsation rate can be varied independently. By changing the flow rate and the pulsation rate, the device will adapt to the experience and tissue differences encountered. The pulsation rate can be controlled by different methods. The pump may stop during pumping, the valve may clog the flow line or the handheld component itself. This approach is well understood by those skilled in the art of fluid flow, and the above examples are not limiting.

[0152] Figure 17 Another embodiment of the invention is shown, which demonstrates the simultaneous use of two devices. Figure 17A combined camera and irrigation probe 171, operating in parallel with a light probe 172 within the human eye 170, are schematically illustrated. Typically, during surgery, one or two incisions less than 3 mm are formed in the eye (often referred to as "primary" and "secondary" incisions). The device described herein is mounted such that it seals the incisions and is able to maintain pressure within the eye during surgery. The two incisions allow for the simultaneous use of two independent devices during the procedure. For illustrative purposes only, these two devices can be combinations of several different features. The first tool may include a camera and irrigation tool inserted into one incision, and the second tool may include an illumination probe. Ophthalmic surgeons will see the practicality of this approach and will be able to design other functional combinations for these two tools. For example, illumination (of any wavelength), laser, irrigation, scraping elements, cameras, and others can be integrated into either tool in any combination. The unique miniaturization features of this invention enable the combination of these features to provide ophthalmic surgeons with the necessary flexibility for optimal operation.

[0153] Figure 18An embodiment of the invention is illustrated, demonstrating the miniaturization capabilities of a medical ophthalmic device and its various components / units. A handheld device 1 is connected to an endoscope unit 3 and a video controller 4 via a suitable connector 2. The endoscope unit 3 includes, but is not limited to, features such as white light balance and light intensity controllers, still image capture, and / or live video recording. Furthermore, washing adjustments and controls can be provided through this unit or may be contained in a separate unit. The endoscope unit is compatible with all electrical connections, such as HDMI, DVI, composite, S-Video, and USB, but is not limited to this list. In this embodiment, the probe consists of various components integrated together at the distal end of the probe unit. In this embodiment, the optical barrel 5 comprises two or more lenses and may contain any number of filters and / or coatings to control any aspect of illumination (e.g., intensity, frequency / wavelength, instantaneous time intervals, waveform, etc.) as needed. Depending on the optical requirements of a specific process, the sensor housing 6 and the optical barrel 5 may be integrated together or separate. Sensor 7 can be chip-based, where the camera, sensor, and optical barrel are integrated / assembled into a single unit, or a more traditional approach is used where the optical components are separate from the sensor itself, and the focusing lens can be adjusted by changing the distance between their surfaces. One or more LEDs 8 are integrated into the distal end of the probe device on a printed circuit board (PCB) 9. The light source can also be provided by optical fiber from an external light source unit to the distal end of the probe. The LEDs can be placed flush with their surface and the distal surface of the optical barrel to further save volume and contribute to miniaturization. LED 8 can also be placed on the same PCB as sensor 6. Furthermore, the camera can also operate without any illumination; this option may be important for further miniaturization of the device for use in high-resolution precision surgery. In the option without the illumination features described here, the probe can operate with the camera at a much smaller scale due to space savings and subsequent miniaturization. Alternatively, a larger chip can be used to provide higher resolution for the same cutting requirements. Cable 18 connects all features of the entire device from the distal end of the probe (where many functional components are located) to the handheld component and external measuring unit. A flexible PCB design can be implemented instead of the cable. The PCB can be angled at 90 degrees; alternatively, two PCBs can be used. The cable 18 connects to the video controller 4 in the endoscope unit 3. Furthermore, the miniature video controller can be placed on the handheld device itself and integrated into the device.

[0154] According to one embodiment of the invention, the tips of the probes may be flexible, allowing them to bend into a U-shape to observe below the cut and to observe by rotating within the left or right side of the region of interest. In this embodiment, the probe support will be made of a conformable material such as a metal or polyamide.

[0155] The probe may have a lateral support cable to allow pulling on the cable in the lateral direction, thereby rotating the probe tip in one or both directions. Because the probe rotates in a circular motion, the ability to bend the tip will allow the probe to point in any desired direction. Due to the relatively small space inside the eye, minimal bending and rotation can point the tip in any desired direction.

[0156] The optical design of a complete objective lens considers several parameters, such as field of view (FOV), depth of field (DOF), pixel size, effective area of ​​the sensor, and the orientation of its optical axis relative to the mechanical axis of the entire solid-state sensor camera. For simplicity, it is assumed that these two axes coincide; if they do not coincide, the movement of mechanical parts and / or components must be considered, or, in the case of aspherical lenses, the mold used for the lens may account for such movement. Other parameters also affect the design, such as the degree of distortion and the F-number. If the distortion is too high, a "fisheye" effect will occur; if the F-number is too high, more light is required to obtain a bright image. Software-driven magnification can magnify the area of ​​interest. When deemed necessary, an OCT can be used instead of a video probe to provide a view through the tissue plane.

[0157] In one embodiment of the invention, the probe may be attached to a medical ophthalmic device. Therefore, according to this embodiment, a reusable medical ophthalmic device can be provided, i.e., it can be sterilized and used in subsequent procedures, while the visualization probe can be disposable. This can be achieved at a low cost by using the methods described herein to manufacture embodiments of the visualization probe according to the invention. Examples may be phacoemulsification tips for cataract surgery, lateral port probes for cutting cataracts or manipulating implants, attached to a MIGS inserter.

[0158] On the other hand, the present invention relates to a medical ophthalmic device comprising a socket or channel adapted to receive a visualization probe having an imager, for example having an outer diameter of approximately 1.8 mm or less. In such a device, the socket may include a signal transmission connector adapted to receive signals generated by the probe and transmit them to a display device.

[0159] As used above, the term "medical ophthalmic device" refers not only to devices used for active surgical procedures on the eyes of humans or animals, but also to devices used solely for diagnostic purposes and devices used for delivering therapeutics and / or medications. Any device introduced into the eyes of an animal or human falls under the definition of a medical device in this specification. Such medical ophthalmic devices may be selected from the following, such as: endoscopes; scissors; scalpels; laparoscopes; flexible, semi-flexible, semi-rigid, or rigid single-lumen or multi-lumen tubes (or conduits) used for treatment procedures or to protect the eye when inserting and removing other devices through these tubes (or conduits); springs; rods; devices for approximating, cutting, and sealing tissues; devices for cauterizing, coagulating, or otherwise destroying objects; devices for supplying, guiding, expelling, or delivering objects or substances; guidewires, forceps, monitoring and / or diagnostic devices; wireless in-vivo devices, etc.

[0160] The invention also includes combinations of medical ophthalmic devices and visualization probes as described above. For example, a solid-state imager may be located at the distal end of a visualization probe attached to the surface of the medical ophthalmic device.

[0161] The objective of this invention, namely, to produce very small-sized visualization probes and medical ophthalmic devices containing them, has been achieved by utilizing the above-described technology.

[0162] It will be apparent to those skilled in the art that all the above descriptions and examples are provided for illustrative purposes and are not intended to limit the invention in any way. The probes of the present invention can be used to manufacture many different surgical instruments, and many such different instruments can be manufactured, including sockets, which, according to the invention, are adapted to receive the probes in different suitable and convenient locations depending on the different tools and procedures used. Therefore, the present invention opens the door to a new generation of medical devices, particularly ophthalmic medical devices, without limiting their shape, probe placement, or intended use. Probes can also be "mounted" without a housing, or mounted within a tool with a housing already included.

Claims

1. A medical ophthalmic device comprising an endoscope having at least one camera, wherein a sensor of the at least one camera is located at the center of the distal end of the endoscope, wherein the camera and one or more components are integrated together at the distal end of the endoscope, wherein the outer diameter of the device is about 1.8 mm or less. in, The camera is located at the center of the far end, and the one or more components are arranged around the camera. The camera has a rectangular shape and the far end has a circular shape. The medical ophthalmic device further includes irrigation and aspiration tools for controlling both irrigation and aspiration, and the camera is integrated into the irrigation and aspiration tools; wherein irrigation and aspiration are performed coaxially, and the coaxiality includes a concentric tube having a central tube and an outer tube; and wherein: -- The central tube is flushed and the outer tube is aspirated; or -- The central tube draws in air and the outer tube flushes.

2. The device according to claim 1, wherein, The main body of the device is adapted to be inserted through an incision of 3 mm or less formed around the cornea during cataract surgery and minimally invasive glaucoma surgery (MIGS).

3. The device according to claim 1, wherein, The body of the device is adapted to be inserted through a cannula used in vitrectomy surgery.

4. The device according to claim 1, wherein, One or more components are lighting sources.

5. The device according to claim 4, wherein, The illumination source is located distal to the distal end of the endoscope.

6. The device according to claim 5, wherein, The lighting source includes a plurality of LEDs positioned around the sensor.

7. The device according to claim 1, wherein, The phacoemulsification tool for cataracts is integrated into the device.

8. The device according to claim 7, wherein, The cross-section of the phacoemulsification tool for cataract surgery can be circular or elliptical.

9. The device according to claim 1, wherein, The flushing and suction tools are used to remove lens cells under direct vision.

10. The device according to claim 9, wherein, The shape of the flushing port is shaped to control the pressure of the fluid.

11. The device according to claim 1, wherein, The camera is integrated into an elliptical-tipped flushing cannula to allow scraping of the eye's sac-like structure.

12. The device according to claim 1, wherein, The camera is attached to scissors and tweezers.

13. The device according to claim 1, wherein, The camera is attached to the cannula.

14. The device according to claim 1, wherein, The component is a laser device.

15. The device according to claim 1, wherein, An external lighting source is adapted to provide illumination according to the orientation of the device.

16. The device according to claim 1, wherein, An external lighting source is adapted to provide illumination according to the orientation of the camera.

17. The device according to claim 1, wherein, The endoscope's tube or tip is made of a transparent polymer material and can therefore be used as a light guide for illumination.

18. The device according to claim 1, wherein, The wavelength of light can change.

19. The device of claim 1, further comprising a socket adapted to receive the endoscope, wherein the socket includes a signal transmission connector adapted to receive signals generated by the endoscope and transmit the signals to a display device.

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