Medical ophthalmic machine device
The medical ophthalmological device with a hydrodissection tool and integrated camera and illumination addresses the challenge of limited visibility during surgeries by enabling precise removal of residual cells and viscoelastic bodies, enhancing surgical precision and reducing complications.
Patent Information
- Application Number
- JP2024153539
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2020-03-30
- Filing Date
- 2024-09-05
- Publication Date
- 2024-12-10
- Estimated Expiration
- 2040-04-30
AI Technical Summary
Current medical tools struggle with limited microscopic visibility during surgeries due to opacity from the iris and blood, leading to complications such as residual cells and viscoelastic bodies remaining in the lens capsule, which can cause secondary cataracts and increased intraocular pressure, and the need for cumbersome tools to visualize tissues like the trabecular meshwork.
A medical ophthalmological device equipped with a hydrodissection tool that includes a camera and a jet of fluid for enhanced visibility, allowing for precise removal of cells and viscoelastic bodies, and integrated illumination and suction capabilities to manage blood and debris, enabling direct visualization of tissues like the trabecular meshwork.
The device improves surgical precision by ensuring complete removal of residual cells and viscoelastic bodies, reduces complications, and facilitates minimally invasive procedures with reduced healing time and risk of infection, while providing direct visualization of critical eye structures.
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Figure 2024170558000001_ABST
Abstract
Description
[Technical field]
[0001] The present invention relates to the field of medical tools. More particularly, the present invention relates to a method for the treatment of various human and / or or medical ophthalmic devices useful for diagnostic, therapeutic and surgical devices suitable for medical / surgical procedures in animals. Regarding. [Background technology]
[0002] Miniaturization is a key factor in enabling precise medical procedures such as surgery, especially in complex organs such as the eye. Moreover, visualization inside the human body could be a key tool for the successful implementation of new imaging techniques (e.g., high resolution). enable doctors to make accurate diagnoses of various diseases, deliver therapeutic drugs, and / or It allows minimally invasive surgery to be performed inside the body. Visualization also reduces the need for incisions. Limit the size of the wound, thereby reducing wound healing time, associated pain and risk of infection. Essential tools to enable surgical techniques that reduce or eliminate the need for suturing It is well known that
[0003] Cataract surgery is one of the most commonly performed procedures worldwide. In the United States alone, 40 With over 20 million procedures performed, it remains one of the leading causes of vision loss worldwide. In the 1970s, tools were developed to remove cataracts using the technique of Over the years, the tool has evolved into what is now called a phacoemulsifier. This tool penetrates a 2.5mm hole in the cornea. They can enter the eye through a catheter incision and use ultrasound to break up the cataract material, then Cataracts are caused by the inside of a very thin membrane called the lens capsule that is trapped in the eye. It is supported within a sphere. It is opened with a circular incision of at least 5.5 mm. The body helps to reduce the risk of cataracts by injecting water under the edge of the lens capsule to allow it to flow around the cataract. The lenses are typically cut by creating a groove through the center, then separating the lenses into halves or quarters. These are then separated using a second instrument into 1. Separate through a smaller lateral incision of 0-1.5 mm. Once the portion is removed, a smaller nozzle instrument is used, which uses suction to , which strips the softer parts of the cataract from the delicate lens capsule. These cells are adherent and difficult to completely remove without violating the lens capsule. For this reason, the cells are usually reduced, but not completely eliminated. The pupil of the eye is dilated 6-10 mm and the lens is typically 12-13 mm in size. Therefore, the lens material underneath the iris is not easily visualized. The suction tool can be used to reach under the iris, but the capsule is not inside the vacuum tip. This operation is strongly discouraged as it can become trapped in the If the capsule appears clear, fill the "bag" with gelcoll viscoelastic and place it in a container for 6m. The I / A implant is pushed into the eye through a 2.5 mm incision. The gel is then removed using a vacuum cleaner again, as the gel dissolves over the first 24 hours after surgery. The gel is transparent and very difficult to visualize. The gel adheres to the posterior part of the lens, the peripheral portion of the lens capsule, and the inner surface of the cornea. The retained lens cells, called lens epithelial complex cells or LECs, , using a round roughened ball called a scraping tool or an olive-shaped tip. Despite these efforts, the first few months of surgery Over the course of months to years, secondary cataracts form in more than half of the eyes.
[0004] To combat this problem, which causes glare and loss of best vision, Israel A new laser called the YAG laser has been developed that penetrates the lens capsule behind the implant. The laser is a disruptive laser that opens the lens capsule and the cells float to the back of the eye. The lens is fixed by an 11mm "arm" that reaches into the capsular bag. Once this procedure is done, vision usually improves, but the patient's vitreous This can result in the presence of floating "floaters" or debris. The rate of swelling in the power center is low. The vitreous enters the front of the eye, so the IOL is easily exchanged. In modern times, we have IOLs that can give patients bifocal vision. These IOLs can cause halos and glare, so they are not recommended for all This is not something patients can tolerate. This is a symptom of what is known as visual impairment. The clinical problem is that patients are unable to exchange their lens tissue for this type of IOL. It is difficult to know whether capsular treatment or replacement will improve vision when patients have If the capsular bag is repaired, the exchange of the IOL becomes very difficult and requires a surgical procedure called a vitrectomy. This requires removal of the vitreous, which can lead to a decentered IOL or risk of retinal swelling. will increase further.
[0005] Using a flattened cannula, the lens capsule was vigorously irrigated with water to remove the retained fibroblasts. It has been noted that the percentage of cells that are outside the field of view below the iris may be reduced. The object of the present invention is to provide a micro-video camera capable of visualizing the inside of the eye. Improved visualization and subsequent power washing of these cells and viscoelastic bodies. The solution is to address this by using equipment specifically designed to do so.
[0006] Glaucoma is the loss of nerve fibers due to neurodegeneration. Increased intraocular pressure causes damage to the optic nerve at the back of the eye. When the nerve fibers are compressed, they are damaged. The fibers are said to be "pinched" When cells die, they enter a phase known as apoptosis, or programmed cell death, which is a leading cause of blindness worldwide. It is the primary cause of glaucoma and its incidence increases with age, paralleling the development of cataracts. The cause of the increase is a reduction in the eye's outflow system and retention of aqueous fluid, which increases pressure. and lasers can be used, and in severe cases, to pass fluid from the eye under the conjunctiva. For the past 15 years, the trabecular meshwork, known as the meshwork for bypassing the outflow of blood, has been A device has been developed to perform minimally invasive glaucoma surgery, or MIGS. There are many variations, but generally, devices are placed through this network during cataract surgery. or the meshwork is stripped away to allow free passage of aqueous humor into the venous collector. This operation is best performed by observing the angle of the eye while looking directly down from the microscope. This is difficult because it is not possible to use prisms and the patient The head must be rotated 45 degrees away from the scope and then the microscope tilted 45 degrees. The gel is placed on the cornea and an angle view is captured. The inserter is inserted into the prism. The device is placed under the eye and dissection is attempted through an incision advanced across the eye and the device. Because the tissue is connected to the vein by pressure on the surface, blood often flows back into the eye and into the eye at an angle. This must be removed with viscoelastic and another attempt is made. Or without the need to tilt the microscope, and the spray system will spray water and remove blood. This allows you to brighten the field of view of the intended target, thus reducing the direct field of view of the angle. This is the intent of this tool. Summary of the Invention [Problem to be solved by the invention]
[0007] The object of the present invention is to provide a tool for carrying out such an efficient medical procedure, as well as many other procedures where microscopic visibility is limited by opacities, irises, or blood. The aim of the project is to improve surgical techniques and reduce potential complications by using cameras, color, and other Including, light source, laser source, scraping tool, pulsation, suction, ultrasound, and gas and / or irrigation (inflow and outflow), including drug injection, It can be incorporated.
[0008] Yet another object of the present invention is to provide a method for the "passivation" of cells and viscoelastic bodies from the lens capsule following cataract removal. "Wah washing" and "the iris, which is hidden behind the iris or simply not visible from a microscopic angle, The color is sometimes increased to make the lipid-covered cells fluoresce from the collagen capsule. The efficacy and safety of further removed cells are easily visible from the enhanced camera angle. The primary objective of the present invention is to combine this with the ability to distract the capsule to improve safety.
[0009] It is yet another object of the present invention to provide a method for opening tissue surfaces, removing blood and debris, and providing a method for removing blood and debris by a suction tool. It can be used to remove residual viscoelastic material trapped in crevices that are normally overlooked by The use of controlled, targeted injections of saline in eye surgery .
[0010] Yet another object of the present invention is to provide a method for treating the trabecular meshwork, ciliary sulcus, Schlemm's canal, ciliary body and subiris region. The camera device is intended to provide visualization of the glaucoma to aid in minimally invasive glaucoma surgery. Eliminates the need for cumbersome tools such as prisms to visualize tissues not visible under the microscope. Implants (stents), shunts, or any other devices can be used. The combination of optical vision to enable delivery and placement reduces intraocular pressure or or shunt delivery.
[0011] Yet another object of the present invention is to provide a medical ophthalmic device capable of precisely delivering drugs under direct vision. The goal is to provide a place where the suction can be removed safely and under direct observation. The needle insertion may be performed by an assistant using the needle. This video device makes it easy to clip or freeze the equipment for long periods of time. can be achieved.
[0012] Yet another object of the present invention is to provide a method for repairing retinal breaks and burning blood vessels for use in glaucoma. To provide a medical ophthalmic device capable of delivering laser output under direct vision for cauterization. And so.
[0013] It is a further object of the present invention to provide a method for treating a vascular endoscopic ocular disease by opening and stabilizing the anterior and posterior chambers with internal flow. To enable standardization of procedures and improve the success rate of procedures in eye surgery .
[0014] A further object of the present invention is to provide a method for the treatment of cataract surgery, glaucoma surgery and vitrectomy, tear duct opening, ophthalmic The aim of this study is to enable trauma and oncology surgery.
[0015] Other objects and advantages of the present invention will become apparent as the description proceeds.
[0016] In a first aspect, the present invention provides a jet of fluid suitable for "hydrascopically dissecting" cells within the eye. A flat cannula adapted to receive flow from the pump unit to generate a The tool includes a handpiece having a grooved tip.
[0017] According to one embodiment of the present invention, the tool removes the cortex or cells from the lens capsule under the incision. Use vacuum or other means to remove any residual viscoelastic or other debris / residue trapped in the crevices. It is adapted to:
[0018] According to one embodiment of the present invention, the tool is a hydrodissection micro camera tool.
[0019] According to one embodiment of the present invention, the tool is adapted to have an external nozzle for aspirating fluid at a suitable velocity for injection. The catheter further comprises a channel configured to be connected to an external suction unit.
[0020] In an embodiment of the tool, the received flow is directed through a flattened cannula in the handpiece. It is controlled before reaching the L-shaped tip.
[0021] In an embodiment of the tool, the flow allows for variation of the flow to a flattened cannula tip. The processing unit is controlled according to inputs received from a control unit for The volume of this can vary depending on the opening of the flattened cannula tip, which affects the velocity. The control unit may be a manually operated unit (e.g., a foot pedal), an automated / autonomous control unit ( For example, it may include artificial intelligence), or any combination thereof.
[0022] In an embodiment of the tool, the flow is adjustable by a control unit (e.g., a foot pedal). The pressure applied to the pump can be varied to change the rate of the pulse. As a result, various sensors will be used to detect and detect the presence of robots using machine learning, artificial intelligence (AI), and programmable software. and autonomously controlling and modifying the flow of said hydrodissection endoscope tool in combination with said software. A database of program settings may be stored in the software package. This allows the user to personalize the user's preferences appropriately for each of the various stages of a particular surgical procedure. This allows for the creation of a digital image.
[0023] In embodiments of the tool, the handpiece may include any other suitable elements (e.g., valves or is designed to control the flow upon depression and release of an actuation button, thereby , continuous flow at lower flow rates or faster as pressure builds up behind the occlusion. Direct the flow.
[0024] In an embodiment of the tool, the flattened cannula tip is replaceable. By narrowing the higher velocity thin cutting flow of the blunted tip, various tips can be achieved. This allows the surgeon to create the best possible Allows for the use of functional slit widths and spreads.
[0025] In embodiments of the tool, the slit openings may be straight or curved, elongated or It may also be of narrow shape.
[0026] In an embodiment of the tool, the redesigned phaco tip operates in ejection mode rather than suction. Both can enable low level ultrasound.
[0027] The tool generates high frequency pulsations to remove material that has built up on the surface, especially the lens cells. The method further includes means for causing the
[0028] In an embodiment of the tool, high frequency pulsation is applied by a pumping unit or by a hand pump. The heat is generated by a high-speed ball valve in the
[0029] In an embodiment of the tool, a high speed ball valve is tensioned to provide faster and slower pulsations. This makes it possible.
[0030] In an embodiment of the tool, the cannula tip of the handpiece is positioned on the inflated lens capsule. To push the cells apart after they have been loosened by hydrodissection The tip has a curved soft surface strip behind the tip.
[0031] In one embodiment of the tool, the pressure-activated ball valve system in the handpiece can be replaced with a simple A flow direction switch controls the selection of continuous or pulsating flow through the same handpiece. or there can be separate handpieces having this continuous capability.
[0032] In an embodiment of the tool, the flattened cannula tip is a biomimetics with separation of flow and suction. This is the tip of the manual.
[0033] In an embodiment of the tool, the flattened cannulated tip prevents abrasion from the softer tip. and made from silicone or other soft synthetic materials to allow for hydrodissection. will be done.
[0034] According to one embodiment of the present invention, the tool manually removes cells from the inflated lens capsule. To achieve this, the device further includes a curved or straight band behind the tip.
[0035] In an embodiment of the tool, the tip is rotated to allow squeezing under the incision. Good too.
[0036] In embodiments of the tool, in order to allow for variable flow rates, along with irrigation and aspiration modes A bi-manual mode configuration may be used. In this case, the bi-manual mode is Redesigned by using a positive pressure pump to power the flow at the tip with the outlet flow. It is controlled by the chip machine to enhance the effect of bi-manual mode.
[0037] In an embodiment of the tool, the handpiece includes a roughened area behind the tip. This region may be planarized to increase the surface area.
[0038] In embodiments of the tool, the tip may be made of a soft, flexible material or may be made of a hard It may be made of a plastic or metal material.
[0039] In embodiments of the tool, the tip may vary in width from about 0.5 mm to 1.8 mm. The opening at the tip is approximately 0.05 mm to 1 mm.
[0040] In an embodiment of the tool, the tip is adapted to remove fluid from the eye at the rate at which the fluid is injected. This is the opposite of current I / A tools.
[0041] According to one embodiment of the present invention, the tool removes debris and skin from the capsule below the incision. A separate aspiration tip is also provided that can be used to increase the ability to aspirate tissue or cells. Prepare for the future.
[0042] In an embodiment of the tool, the hand piece provides better visibility of the adhering cell layer. To achieve this, a visualization probe is provided.
[0043] In an embodiment of the tool, the visualization probe is a video Includes camera.
[0044] In an embodiment of the tool, the light source reflects the stained and unstained cells. The light source can be white or colored to cause radiation / absorption. The illumination may be integrated within the device and / or illumination may be provided from an external source.
[0045] In an embodiment of the tool, the hydrodissection tool allows suction and propulsion to work together. The tip is configured to allow a bi-modal arrangement for this purpose. In this mode, the camera and exhaust The output nozzle is in one handpiece and the illumination and suction are in the other handpiece. As will be appreciated, any combination of these features may be embodied, for example: The camera and lighting can be located on one handpiece, and the exhaust nozzle and suction can be placed on the other handpiece.
[0046] In an embodiment of the tool, the camera performs irrigation and aspiration, and then hydrodissection aspiration. It is designed to be bi-modal, allowing switching between I / A devices. In this form, they may be selected based on the surgeon's experience and needs. The same equipment can be used when the
[0047] In embodiments of the tool, the tip may be an I / A tool, a phaco tip, a syringe, or Placed on any drainage tool, including an IV flow device, that is elevated to provide pressure Good too.
[0048] According to one embodiment of the invention, the tool further comprises staining means for cell identification purposes. The staining means is selected from the group consisting of illumination, staining substances, or combinations thereof. Autofluorescence can be enhanced by a number of stains. Autofluorescence ranges from capsule collagen to lipid cell wall proteins. It may be noted that the endothelial cells are differentiated from the endothelial cells.
[0049] According to one embodiment of the present invention, the tool balances the inflow and outflow of fluids and controls the flow of fluids through the lens. The capsule material is removed, the capsule is secured, scraped, and the crystalline lens is inserted behind a soft scraping ridge. It further comprises a semi-flat surface with small holes for scraping off the body capsule.
[0050] According to one embodiment of the present invention, the camera shaft is made of a deformable plastic, metal, It may be made of polyamide or articulated pieces, which may be oriented, for example, at 45 to 180 degrees. It may be bent or rotated to allow for diversion so that the probe can be viewed from the opposite side of the eye. It allows the area below the incision to be visualized and treated without re-entering the eye.
[0051] According to one embodiment of the present invention, the camera tip is rotated without being withdrawn from the eye. Rubber, silicone, with side strings or wires that can be shortened to achieve any angle of view The tube may be constructed of a flexible material such as a hydrogel. The elbow may have one or more joints that can be moved.
[0052] According to one embodiment of the present invention, the tool is configured to scrape the lens to avoid trapping the lens capsule. On the upper side, away from the pinning element, there is a vacuum port (e.g., a slit It has suction behind one side of a hole (which may be in the form of a shape, hole, or larger opening) The device further includes a double-sided scraping tool (eg, about 0.1 to 0.3 mm).
[0053] According to one embodiment of the present invention, the tool has a tip that is visible through a visualization probe. The attachment can also be used to attach a gripping or cutting tool. These include the use of binoculars, which allow the user to perform tasks outside of the iris field of view. Manual (bimanual) is fine.
[0054] In a second aspect, the present invention provides a camera-equipped medical ophthalmoscope having at least one camera. The device includes at least one camera sensor that is inserted into the eye for intraocular imaging. The imaging device is positioned distal to the tip of the camera such that the imaging device can be seen.
[0055] In an embodiment of a medical ophthalmic device, the size of the device is tailored for its intended use. Through the primary incision, larger instruments may be used for certain techniques. is set by the desired application. Larger tips may be required for a particular procedure. It provides higher resolution than conventional resolution, which can be achieved through smaller incisions. This can provide several advantages.
[0056] In an embodiment of the medical ophthalmic device, the body of the device is a trocar used in a vitrectomy procedure. The device is small enough to be inserted through the
[0057] In an embodiment of a medical ophthalmic device, the diameter of the device limits the size of the incision required. and thus reducing wound healing time, associated pain, and risk of infection. The device is adapted to allow minimally invasive surgery using a surgical technique with an incision of less than 3 mm. The size has been shown to provide a watertight seal at the end of the procedure when properly constructed. This reduces or eliminates the need for sutures and is therefore applied through an incision of 3 mm or less. The medical device that can be used provides safety and minimal refractive change. All these embodiments are , can be designed to provide full functionality based on surgical goals and needs.
[0058] In an embodiment of the medical ophthalmic device, the diameter of the device is less than about 1.8 mm. However, Larger versions of cameras with larger chips may be fine with less than 3.0mm. cormorant.
[0059] In an embodiment of the medical ophthalmic device, the illumination source is integrated into said device.
[0060] In embodiments of the medical ophthalmic device, the illumination source may be located distal (i.e., at the tip) or distal to the device. can be located proximally (i.e., within the handpiece).
[0061] In an embodiment of the medical ophthalmic device, the distal illumination source comprises at least one light emitting diode (L ED).
[0062] In an embodiment of the medical ophthalmic device, light is transmitted internally via optical fibers and / or light guides. Reach the distal end of the endoscope.
[0063] In an embodiment of the medical ophthalmic device, a phacoemulsification tool is integrated into said device. A phaco tip was attached to allow for internal viewing from the tip, which was determined to be useful. It can be.
[0064] According to an embodiment of the present invention, a medical ophthalmic device is provided for removing lens cells under direct vision. For example, this may include a tool for detecting blood in the cornea from swelling or staining of the cornea. It may be used where visibility is impaired.
[0065] In an embodiment of the medical ophthalmic device, the tool for removing lens cells under direct vision includes an irrigation tool, suction tool, or a combination thereof.
[0066] In an embodiment of the medical ophthalmic device, irrigation and aspiration are performed in concentric circles (i.e., one on the inside and one on the outside). either integrated into the first circle, one into the outer circle, or they are adjacent but at the same tip. For example, they may be placed in a stent to facilitate removal of the stent, as determined by the goals and experience of the surgeon. Even though it is switchable, it allows the exhaust or vacuum to be switched good.
[0067] In an embodiment of the medical ophthalmic device, the shape of the irrigation port is shaped to control pressure. do.
[0068] In an embodiment of the medical ophthalmic device, the camera is attached to the forceps and scissors tool. .
[0069] In an embodiment of the medical ophthalmic device, the camera is manually operated to provide the water release. It is attached to a cannula that is
[0070] In an embodiment of the medical ophthalmic device, a laser device is incorporated into said multipurpose eye surgical device. .
[0071] In an embodiment of the medical ophthalmic device, the external illumination source provides illumination according to the device / camera orientation. It is adapted to provide.
[0072] In an embodiment of the medical ophthalmic device, the tip of the tube or endoscope is made of a transparent polymeric material. and thus can be used as a light guide for the light generated by the illumination source.
[0073] In an embodiment of the medical ophthalmic device, the wavelength of the light can be varied. [Brief description of the drawings]
[0074] [Figure 1A] FIG. 1A illustrates a schematic perspective view of a head section of a hydrodissection camera tool, according to one embodiment of the present invention. [Figure 1B] FIG. 1B is a schematic diagram illustrating a top view of a head portion of the hydrodissection camera tool of FIG. 1A, in accordance with one embodiment of the present invention. [Figure 1C] FIG. 1C illustrates a schematic side view of a head section of the hydrodissection camera tool of FIG. 1A, according to one embodiment of the present invention. [Diagram 2] FIG. 2 illustrates generally a perspective view of a head section of a hydrodissection camera tool according to another embodiment of the present invention. [Figure 3A]FIG. 3A illustrates generally a side view of a medical-ophthalmic device having an illumination source (eg, multiple LEDs, xenon arc lamp, etc.) disposed at a distal end of the device, according to one embodiment of the present invention. [Figure 3B] FIG. 3B illustrates a schematic side view of a medical-ophthalmic device having an illumination source showing the location of an optical fiber located on a distal handpiece, according to an embodiment of the present invention. [Figure 3C] 3B illustrates a schematic cross-sectional view of a tip portion of the medical ophthalmic device of FIG. 3A, according to one embodiment of the present invention. [Figure 4A] FIG. 4A illustrates a schematic side view of a tip of a medical ophthalmic device having a camera and an LED, according to one embodiment of the present invention. [Figure 4B] 4B illustrates a schematic cross-sectional view of a tip portion of the medical ophthalmic device of FIG. 4A, according to one embodiment of the present invention. [Diagram 5] FIG. 5 illustrates, in accordance with an embodiment of the present invention, a schematic side view of a tip of a medical ophthalmic device having a camera and LED on the same PCB in one embodiment. [Figure 6] FIG. 6 shows a schematic side view of a tip of a medical ophthalmic device with a camera and an LED behind it, according to one embodiment of the present invention. [Figure 7] FIG. 7 illustrates a schematic cross-section of a medical-ophthalmic device including a laser, a camera, and illumination, according to one embodiment of the present invention. [Figure 8] FIG. 8 illustrates a schematic of an olive-shaped tip of a medical-ophthalmic device according to one embodiment of the present invention. [Figure 9] FIG. 9 illustrates the bi-manual mode diagrammatically. [Figure 10] FIG. 10 illustrates a schematic of a disposable tip with a reusable handpiece, according to one embodiment of the present invention. [Figure 11] FIG. 11 illustrates a schematic of a distal tip of a medical-ophthalmic device with openings for irrigation or vacuum, according to one embodiment of the present invention. [Figure 12] FIG. 12 illustrates a schematic cross-section of an irrigation tube of the medical-ophthalmic device of FIG. 11, according to one embodiment of the present invention. [Figure 13] FIG. 13 shows a schematic cross-section of the distal end showing openings for irrigation or vacuum, according to one embodiment of the present invention. [Figure 14] FIG. 14 illustrates a schematic diagram of a medical ophthalmic device with irrigation and a camera sensor located at the tip of the device, in accordance with another embodiment of the present invention. [Figure 15A] FIG. 15A illustrates a schematic diagram of a medical-ophthalmic device having multiple LEDs and a camera disposed at the proximal end of a handpiece, according to one embodiment of the present invention. [Figure 15B] FIG. 15B illustrates a schematic diagram of a medical-ophthalmic device having multiple LEDs and a camera disposed at the proximal end of the handpiece, according to one embodiment of the present invention. [Figure 16] FIG. 16 illustrates generally a cross-sectional view of another configuration of a camera and multiple LEDs disposed at a proximal end of a handpiece of a medical ophthalmic device, in accordance with an embodiment of the present invention. [Figure 17] FIG. 17 illustrates a schematic diagram of a combination camera and irrigation probe operating in parallel with an optical probe in a human eye, according to one embodiment of the present invention. [Figure 18] FIG. 18 illustrates a schematic diagram of a medical-ophthalmic device having various components, according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0075] In one aspect, the invention described herein provides the surgeon with a continuous / Cannula approach by providing pulsating flow and controlling the force from the fluid flow The hydrodissection tool (in any one of its embodiments) is In the book, it is simply called "tool".
[0076] 1A-1C show a head section of a hydrodissection tool 10 according to one embodiment of the present invention. The head section of the hydrocuting tool 10 includes one or more vacuum poles. The tool 10 includes a scrubbing element 11, a soft and flexible scrubbing element 12, and a scrubbing element 13 disposed at the distal end of the tool 10. In this embodiment, the tool 10 is used as a handpiece. In this embodiment, the vacuum port 11 has an elongated body adapted to receive a quartz crystal. It is placed above and away from element 12 to avoid trapping the body capsule. The vacuum port 11 is provided in the form of a hole, but may also be in the form of a slit or other suitable for suction. Other configurations of vacuum ports or ports can be used, such as a suction port or a suction port.
[0077] FIG. 2 illustrates a head section of a hydrodissection camera tool 20 according to another embodiment of the present invention. The head section of the hydrodissection camera tool 20 includes a water jet port 21 and , a soft and flexible scrubbing element 22, and a camera disposed at the distal end of the tool 20. 23. In this embodiment, the tool 20 also has an elongated body. Thus, the tool 20 can be used as a handpiece. According to an embodiment (e.g., the embodiment shown by the numeral 12 in Figs. 1A to 1C and the embodiment shown by the numeral 22 in Fig. 2), ) The soft, flexible scrubbing element is optional and therefore Latour does not have to include such elements.
[0078] In one embodiment of the present invention (e.g., as shown with respect to port 21 in FIG. 2), the water jet of the tool The flow rate of fluid through the injection port can be controlled by the width and angle of the tool. Furthermore, the water flow can be pulsed or continuous, according to the surgeon's requirements. For example, by pumps from either the cataract removal unit or the vitrectomy unit. According to some embodiments of the present invention, the tool may also include its own water source. or a pump unit. The shape and cross section of the water outlet port 21) can vary. During eye surgery, the effluent flows quickly. If the cross section is too large or too narrow, the effluent may tear through the lens capsule of the eye. In addition, the pulsation rate and flow rate per pulse are related to the effluent flow rate as well as the effluent velocity. It has a dynamic effect related to its width and height. If the pulsation rate is high, the shock waves of the outflow can penetrate the lens capsule. According to one embodiment of the present invention, these restrictions are To limit the possibility of damage, the device software is set in the flow software.
[0079] According to one embodiment of the present invention, any soft, flexible material that is curved at the base and sides. (e.g., silicone) flexible scraping tool (Figures 1A-1C, respectively) 2 and elements 12 and 22 in FIG. 2) may be incorporated into the tool to provide a strong attachment to the lens capsule. The cells can then be scraped off with a reverse painting motion of the scraping tool. According to one embodiment of the present invention, the tool includes a head section having a tip. The lens includes a curved or straight section behind the lens, allowing gentle movement relative to the lens capsule. to mechanically remove or loosen the cells and then immerse them in water by the tip. It can be made to be swept.
[0080] In another aspect, the present invention provides a method for detecting a human subject having at least one camera (e.g., a video camera). A medical ophthalmic device having a visualization probe, the sensor of at least one camera being an intraocular The ocular target is positioned distal to the tip of a tool that is inserted into the eye for imaging from the ocular surface.
[0081] Relates to digital video cameras in general, and in particular those designed for use in endoscopic equipment. The standardization of the terminology used in the literature is very poor. Unless otherwise specified, the following terms are used:
[0082] The terms "active area", "pixel / s area" and "array of pixels" refer to the area that converts incident light into electrons. By "exchange" we mean the light-receiving surface of an array of photosensitive elements, e.g. photodiodes, which exchange light. be used as possible.
[0083] The terms "sensor," "chip," "solid-state image sensor," and "image sensor" refer to an active area. an array of microlenses that focus the incident light onto the photodiode; an array of filters; For color sensors, the term is used interchangeably to refer to the silicon substrate on which the active area is fabricated. For sensors manufactured using CMOS processes, these terms are used interchangeably. The device is adapted to process the output signal of a photodiode mounted together with the array on the This may also include electronic devices.
[0084] The term "solid-state imager" or simply "SSI" as used herein refers to a signal Additional processing to create additional functionality on the same silicon or as additional layers Any suitable solid-state imaging device (eg, CMOS or CCD) including electronic circuitry is depicted.
[0085] The term "camera head" refers to a device that focuses light onto an active area enclosed within a single package. This refers to the SSI and associated optics required to achieve this.
[0086] The terms "video camera", "camera" and "microcamera" refer to the camera head alone. and interchangeably to point to the camera head and additional electronic drivers (if any). Used.
[0087] The term "camera" refers exclusively to video cameras.
[0088] According to one embodiment of the present invention, miniaturization allows for obtaining high quality images (without merely As an example, a camera image sensor with a quality of at least 30k pixels ), while the body of the device is formed around the cornea (e.g., during cataract surgery and MIGS). According to some embodiments of the present invention, By way of example only, the device may have an outer diameter of about 1.8 mm or less, thereby allowing for minimally invasive surgery. Allows for easy implementation (i.e., limits the size of the incision required and therefore accelerates wound healing) (enabling surgical techniques that reduce healing time, associated pain, and risk of infection). The outer diameter of the can vary according to the dimensions of the elements / components that the device comprises. For example, ,The camera resolution may affect the camera outer diameter, and ,hence the high resolution The camera may have a larger diameter than a lower resolution camera. Less than 3 mm The incision size self-seals well, causes negligible refractive error, and So depending on the surgeon's job and needs, a bigger camera and full functionality of the tool i.e., it can be easily adapted for illumination and hydrodissection and depiction. , making it possible to miniaturize several components within one tool for microsurgical procedures The present invention relates to a surgical device equipped with optical visualization means, so that the functions can be reversed as necessary. It can also be used when splitting in manual mode.
[0089] According to another embodiment of the present invention, all the features described herein are achieved in one surgical procedure. The system can be integrated into one tool that is accessed via a single opening.
[0090] In the context of this application, the term "effective diameter" refers to the diameter of the probe, regardless of the shape of the probe. Refers to the final diameter of the lobe. In most cases, the final shape of the probe is circular, but for SSI Despite the fact that typically has a square or rectangular configuration, any other The effective diameter is therefore equal to the longest cross-sectional dimension of the probe. Thus, for example, for a probe with a square cross section, the effective diameter is Equalize the diagonals and make any necessary changes to create a rectangle, oval, or unfinished ellipse The same arguments apply to shape.
[0091] According to one embodiment of the present invention, the visualization probe integrates the signals generated by the SSI. In most cases, the SS The advantage of using CMOS over CCD as an I.S. is that it is much faster and more cost-effective than other methods of image or digital processing. Features required to generate the signal, e.g., Correlated Double Sampling (CDS), A / D, gain, etc. Easy to implement electronic circuits that embody some of the key features required These circuits are realized using transistors in a single package. The design is then added to by a pure sensor built from pixels implemented in a The implementation of the filters is based on 2 transistors per pixel, or 3, 4, 5, 6 or more. Alternatively, shared transistors or other designs, such as 2T2S or 4 By using T4S, or higher order shared transistors to implement the pixel Obviously, these circuits will require larger package sizes and more power. In addition, if you are using signals with higher clock rates, you should add amplifiers. or a driver with a regulator, a few capacitors for noise reduction, and a signal It is preferable to use some resistors to match the Drivers) add space within the package or silicon and therefore in most cases , implemented either external to the packaged CMOS or as an additional layer within the silicon structure. do.
[0092] If the CMOS has a diagonal smaller than 1.0 mm, the driver can be, for example, Implemented in a CDS unit or in the packaged CMOS sensor itself ,To generate an image, which is nowadays shifted externally to the driver or image processing unit, In such a case, the CMOS sensor may include image processing features, such as other features required for A sensor is needed to provide a signal and to pump out the raw signal from the CMOS. It will contain only minimal circuit implementation. In addition, the driver will have to start the CMOS and The minimum required time to match the clock signal required to send the signal to the video processing unit. It contains a minimal number of components that process the raw signal and convert it into a video signal. This device contains all the circuitry and components necessary to convert
[0093] In this way, the CMOS sensor acts almost as a pure imager, redirecting photons The driver also uses the smallest number of components ( One or two, sometimes even zero, The overall dimensions of a properly packaged CMOS video camera can be minimized. Further problems to be overcome are the CMOS design and the need to activate the CMOS and A cable (all wired) that is responsible for delivering a signal to a video processing unit. The common practice is to provide these services There are several wires to
[0094] Several technical solutions for minimizing the area of the imaging device are disclosed in U.S. Pat. For example, a solid-state imaging device having a diagonal of less than 1.0 mm is described in US Pat. To overcome this problem, there is not enough space for so many pads in the current installation. In order to achieve this, it is necessary to set a minimum number of pads (ideally one pad). By multiplexing several signals using the It is possible to use only one pad, or sometimes three pads. Another way to obtain the output of the imager is to use the current method instead of the voltage method. The methodology for the video signal is changed. This also means that the external driver requires a matching stage circuit. The advantages of using such a method include amplification Better filtering of noise related to video signals and video downconversion to compensate for degradation of the video signal. By using a regulator controlled by the op amp, it can be used for longer distances. The new standards include the ability to transmit video signals over a wide area, reducing the size of the SSI. Another example of the method is a configuration having two functions, namely, the function of acquiring an image and the function of transmitting an image. In addition to the above technical reduction solutions, the PCB A compact arrangement of CMOS chips with or without For details, see Brochure No. 2210 and Brochure WO 2005 / 115221. Therefore, the method of manufacture of these assemblies is not described herein for the sake of brevity. This will not be explained in detail in the subsection.
[0095] Reference will now be made to certain embodiments of the invention, examples of which are illustrated in the accompanying drawings. Several embodiments of the present invention are now described by way of example only. From the following description, it is understood that the present invention can be practiced without departing from the principles of the present invention as described herein. It will be readily understood that alternative embodiments of the structure shown in the drawings may be used. cormorant.
[0096] According to one embodiment of the present invention, the visualization probe is a camera integrated into a medical ophthalmic device. The attachment of optical fibers to these tools greatly affects the usability, effectiveness, and In some embodiments, the scope of functionality can be expanded, for example, as shown in FIG. As shown in Fig. 3A and 3B, various colors and intensities were used to visualize the lens cells to be removed. Fiber optics or LEDs can be used to deliver light of various wavelengths. According to one embodiment of the present invention, an illumination source 31 (e.g., a plurality of Illustrated is a schematic diagram of a medical-ophthalmic device 30 having a light source (LED, xenon arc lamp, etc.). For example, if illumination source 31 is one or more LEDs, reference numeral 32 may be a FIG. 3B shows wiring from a power source or lighting control module connected to the According to an embodiment, a medical-ophthalmic device 30 having an illumination source including an LED and an optical fiber is illustrated. In this embodiment of FIG. 3B, the device 30 includes a light source 34 and a light source 36. 3C shows a camera sensor according to an embodiment of the present invention. 3B is a cross-section of the tip of the medical ophthalmic device of FIG. 3A showing the arrangement of four LEDs 31 surrounding 35. FIG. 7 shows a schematic diagram of a laser fiber 71 and a camera according to an embodiment of the present invention. 1 shows a schematic cross-sectional view of a distal end 70 of a medical-ophthalmic device comprising a stent 72 and an illumination source 73. 8 shows an olive-shaped tip 80 of a medical ophthalmic device according to an embodiment of the present invention. Schematically shown.
[0097] In another embodiment of the invention, the light source is: (1) distally on the tool, i.e., direct illumination; or (2) within the body of the tip that includes a light guide to the distal end; or (3) to direct light to a target area. (4) a microscope, a xenon lamp, or on the outer body of the tool having optical fibers guiding the External illumination from a xenon lamp / LED or other illumination source and optical bundle placed outside the eye (5) through an external light source, such as an endoilluminator inserted into the eye parallel to the camera Cells illuminated under different light wavelengths show different Thus, illumination is important for identification purposes. At the end of the lean-up, the water pressure is then adjusted to a blue light source. Irradiate adherent cells using a dissection tool and hydrodissect and scrape them off using a separate tool According to an embodiment of the present invention, other Staining means can also be used. For example, the tool is Trypan Blue 0.1%, Gentian Dyeing materials such as 0.001% amber violet and 0.5% indocyanine green (ICG) For example, the dye material can be mixed with saline. The effluent can allow for mixing of the dyeing compounds. Compounds designed to reduce genic opacity were used after all cell layers were removed. The current confounding issue of adherent cells issue), we will investigate the natural history of collagen and how it is induced. It is better understood how the light can be guided and remain transparent.
[0098] In another embodiment of the invention, the laser is used for purposes such as distance measurement, laser cutting, phototherapy, It can be integrated into tools to perform various optical procedures such as laser eye surgery and photoablation. In addition, the wavelength of the laser light can be varied to suit the specific requirements of the task. Low energy laser light can be used to identify adherent cells without the need for staining compounds. Could be useful.
[0099] In another embodiment of the present invention, an ultrasound tool is incorporated into the phacoemulsification device.
[0100] The light source can be external, making the tool compatible with any externally connected light source For example, see Figures 3A and 3B. Viewing cells at the angle of the instrument tip The ability to do so will allow surgeons to complete the job of removing cells in areas of the eye that are currently not visible from the microscope above. Colored fiber optics combined with LED cross-illumination and video observation The angle and placement of the video camera are limited. Typically, video cameras are 1.0 mm in size (or smaller). There may be a vacuum portion or an exhaust component or both of a bimodal system. This unit has a slit opening for vacuum of 0.2 mm or more. 3A to 8 show the configuration of the camera and the light source. FIG. 1 illustrates the different options available for the positioning of the light source in the light guide. and / or may be guided externally by optical fiber or may be located at the tip itself (i.e. 4A and 4B show an embodiment of the present invention. In one embodiment, the illumination source 41 and the camera 42 are disposed at the distal end 40 of the medical ophthalmic device. In this configuration, the illumination source 41 is placed above the camera 42. In one embodiment, the camera 52 and the LED 5 are mounted on the same PCB 53. FIG. 6 shows a schematic side view of a distal end 50 of a medical ophthalmic device having a stent 1. According to an embodiment, the tip of a medical ophthalmic device having a camera 61 and an LED 62 behind it 2 shows a schematic side view of part 60.
[0101] The light sources themselves include microscope lights, incandescent bulbs, operating room lights, light-emitting diodes (LEDs), and fluorescent bulbs. , xenon arc lamps, and the like. These can be used individually or in combination. According to one embodiment of the present invention The light source is in the form of an optical probe adapted to be inserted parallel into the device. The availability of a variety of light sources is essential as surgical procedures often require procedure-specific lighting. Furthermore, the light irradiation is performed by a light guide and an optical fiber (see Fig. 3A and Fig. 3B). Furthermore, the color of the light source is not limited to white light, and the user can select the color of the light source. The present invention can include any color and / or wavelength that helps to perform the above-mentioned steps. According to an embodiment, the removable / replaceable distal end includes one or more LEDs having different wavelengths. For example, the color may be determined by software if RGB LEDs are used. can be managed.
[0102] In one embodiment of the invention, the flow rate of fluid through a tool is controlled by the width and angle of said tool. Furthermore, the water flow can be pulsed or continuous, depending on the surgeon's requirements. The flow can be continuous from either the cataract removal unit or the vitrectomy unit. The flow may also have its own source. The shape and cross-section of the exit port of the fluid flow tip can be varied. During this process, if the outflow is too fast or its cross section is too narrow, it may tear and penetrate the lens capsule. In addition, the pulsation rate and flow rate per pulse are related to the effluent flow rate as well as the effluent velocity. It has dynamic effects related to width and height. If the pulsation rate is high, the shock waves of the effluent can rupture the lens capsule. These energy limits are important because they allow the surgeon to overcome these limitations. This is set in the pump software to prevent fluid from being placed at the distal end. The optical fiber and / or camera pass between the apertures, which define the flow direction and pressure; For examples of embodiments of the present invention, see Figures 11-13.
[0103] In another embodiment of the present invention, the hologram may be made of any soft, flexible material that is curved at the base and sides, such as A flexible scraping tool (e.g., silicone) can be incorporated into the device to firmly attach to the capsule. The cells that adhere to the surface can be loosened and then scraped off with a reverse application motion of the scraping tool. The device does not include a curved or straight section behind the tip. This allows gentle movement against the capsule to mechanically remove the cells. or the cells are loosened and then swept away by the tip.
[0104] In another embodiment of the invention, the tip allows for subcapsular angulation if desired. The outer sleeve may be angled to direct the flow of air into and out of the outer sleeve. The flow through the tip is proportional to the resistance / flow rate. If the flow rate remains constant, the resistance increases the pressure, which in turn forces the fluid Generally, the objective of the present invention is to provide a lens that is resistant to flow against the capsule. The goal is to create a flat or slightly curved fluid plane that encounters a resistance. They are adherent cells and viscoelastic bodies that remain in the aqueous humor of the anterior and posterior chambers. The shape of the end is essential to the concept of the tool.
[0105] In another embodiment of the invention, the exhaust part of the device, in a bi-manual version, The size of the exhaust portion may be separated from the suction or return portion. The drainage portion is placed through a smaller incision, such as a drainage port, or through an additional incision. For an illustration of this embodiment, see FIG. See, where the bi-manual mode is used with the camera and cleaning tool. 91 is inserted into the eye 90 through the second incision, while the suction tool 92 is inserted into the eye 90 through the first incision. and inserted into the eye 90.
[0106] In another embodiment of the invention, the suction portion of the unit is adapted to receive a light source, a video camera, or a dye. An injection unit may be incorporated to place the color compound on the capsular bag. As with residual viscoelasticity, it can be used to visualize lens cells. The use of the iris improves the visibility of residual cells. This tool provides a view behind the iris. So place a grasping tool or cutting tool to perform procedures not visible from the microscope on The device may be provided with an attachment for
[0107] In another embodiment, the camera is integrated into the tool that uses irrigation and suction. The camera and lighting may be integrated into the cleaning tool only (bi-manual for cataract surgery). By way of example only, the irrigation channel may be of any cross-sectional shape (e.g., several small the free space between the components of the outer tube or the outer tube) and shall be at least 0.3 mm. For example, the outer diameter may be about 1.5 mm. The tool may also be and / or through a secondary incision. For surgical convenience, the tip may be permanently They may be permanent (reusable) or removable (disposable). For an illustration of a disposable tip 102 having a handpiece 101, see FIG. I want to.
[0108] FIG. 11 shows an embodiment of the present invention with an opening 112 for irrigation or vacuum. The medical ophthalmology device 110 is shown in schematic form with a camera 11. 1, an opening 112 for cleaning or vacuuming, and an illumination source 113. 1 is a distal end of a medical ophthalmic device 110 showing an irrigation tube 114, according to one embodiment of the present invention. In this embodiment, water flows through an irrigation tube 114 and 13 shows a tip end according to another embodiment of the present invention. An opening 131 for irrigation or vacuum is arranged around the camera 132 located 1 illustrates a schematic cross-section of a distal end of a medical ophthalmic device, showing:
[0109] FIG. 14 illustrates a schematic diagram of a medical ophthalmic device 140 according to another embodiment of the present invention. 40 includes a cleaning port 142 and a tip 141 where a camera sensor (not shown) is located. The flow rate is controlled by a flow controller 14 located on the body 144 of the device handpiece. In this embodiment, the device 140 can be controlled via a cable 145 1. The device 140 is controlled via an operating unit (not shown) electrically connected to the device 140 via Power is supplied.
[0110] 15A-15B show a multiple LED 152 and a hand pin according to one embodiment of the present invention. 1 shows a schematic diagram of a medical ophthalmic device 150 having a camera 151 disposed at the proximal end of the base. FIG. 16 shows another view of a camera 161 and multiple LEDs 162 located at the proximal end of the handpiece. Schematically shows a cross-sectional view of the arrangement.
[0111] In another embodiment of the invention, the tip pushes the spread of the fluid in a downward or upward direction. It may be angled to remove attached debris and lens cells. While "peeling" the lens, angle the surface of the membrane to place minimal tension on the capsule Therefore, the gap and width of the tip are important for the function and safety of the device. It is very important. The width and gap of the tip have some variations and Users can choose the tip that best suits their experience and goals. The tip may have a width of 0.5 mm to 2.5 mm. can vary from about 0.05 mm to 1 mm and can include curved or straight shapes. The tip can also loosen cells from a surface behind a jet of fluid. In this way, the capsule may have a roughened underside to allow for better contact with the lens. The capsule is rolled or folded over and then pulled flat in front of the roughened area. The roughened area may also be widened to reduce the risk of subsequent catching and tearing. Allow the expanded surface area to be removed or loosened prior to the hydrodissection cannula. In this way, the risk of puncturing the delicate lens capsule is reduced.
[0112] In another embodiment of the invention, the tip material is a soft plastic to allow gentle cutting. It may be metal combined with the ribbon element.
[0113] In addition, the tip is made up of a piezo element, two tubes, an outer rigid tube and a pre-insulated tube. A removable metal inner tube is used with a semi-rigid or flexible inner tube formed therein. The wire may be used to provide adjustable stiffness. can be rotated to provide a variable view from the camera to direct the flow.
[0114] The present invention allows for a procedure to remove lens fragments under direct vision. Combinations of the following may be used, but are not limited to this list: camera with suction, camera with irrigation and suction, camera and phaco probe camera and features that allow precise rotation and positioning.
[0115] The present invention enables glaucoma surgery. The camera provides visualization of the ciliary sulcus and subiridal space. This eliminates the need for a gonioscope. The camera can be attached to the treatment device and can also be inserted through a second incision. The camera can also be used to view stent delivery tools, shunt delivery tools, and the like. The device may also be placed in parallel with a therapeutic device such as a catheter or the shunt itself. According to some embodiments, the camera can be integrated into the implant delivery tool.
[0116] The present invention provides a method for treating a corneal graft inserted into an eye when the anterior portion of the eye is opaque (e.g., an opaque cornea). This enables the vitrectomy procedure in which the camera can act as a visualization tool. In this mode, the camera is small enough to pass through the trocars used in surgery and to view the position of the sutures. For anterior procedures, the curved tip can be used to aid in the placement of the eye and the removal of intraocular foreign bodies. For vitreoretinal procedures, a straight tip can be used. .
[0117] A curved band, which can be made of a flexible material such as silicone, is attached to the back of the injection zone. This is done by stroking the tissue that has been flattened before the outflow. The curved zone behind the tip can be used to adjust the It may be a hard material, based on the physician's preference.
[0118] The curved tip can be adjusted to follow the posterior curvature of the lens capsule. The ideal angles of the ends may be effectively parallel or (for example only) However, an angle of 5 to 25 degrees or more may be used. This can be achieved by angling the external device. This may be achieved by using a rough (e.g., silicone) or a coarse (e.g., diamond) ) or have either a rough synthetic or metal surface or scraping elements It may be incorporated into the tip.
[0119] Typically, water entry is achieved by spilling through the side of the device or by "bi-manual" In bi-manual mode, two tools are used to In bi-manual mode, two separate tools are used to deliver blood to two separate incisions. According to one embodiment of the present invention, the tools are inserted and operated simultaneously. Irrigation and suction can be performed through a single channel, i.e., without the need for two separate tools. In this embodiment, the operation of the irrigation and aspiration device includes both aspiration and aspiration from the tip. The flow is reversed by the outflow and the return flow along the sides of the instrument. The tip also becomes stuck and As a tool to act on a distended capsular bag with less risk of tearing Viscoelastics may be used from the posterior and anterior of the IOL, as well as in the iris sulcus and corners. It can be released completely within the dome of the membrane.
[0120] In another embodiment of the present invention, the inflow and outflow of water is controlled in a manner similar to the bimanual approach. In this approach, irrigation and aspiration can be controlled through the same tool. The drawing can be performed by a) two parallel tubes or b) the coaxial method. The row tube method allows the tube inlet and outlet to be placed anywhere on the distal end of the probe, e.g. For example, they have the advantage that they can be located next to each other or far apart. On the other hand, the coaxial method uses a 100% axial load, not only along the probe itself but also at the distal end of the probe. It helps miniaturization by saving volume space. The coaxial method has a central tube for irrigation and an outer tube for Both methods involve a second incision through a second tube, where the catheter is sucked in, or vice versa. It has the advantage of being tool-free, compact and integrated into a single tool.
[0121] The tip can be used to improve sub-incision clearance by directing flow from a side port or a second incision. The closer to complete removal of cells from the eye, the greater the recovery. The expected impacts are lower in the second stage.
[0122] Lens particles, cortex and viscoelastic material are often hidden under the iris. With the suction tool If they reach these areas, they can damage the lens capsule, resulting in zonular dehiscence or capsule rupture. The great advantage of aggressive irrigation versus aspiration is safety and efficiency. The light makes removal visible and certain. Residual lens material can be easily removed even with a thin layer of tissue. In particular, nuclear material can result in chronic or acute inflammation, which can lead to delayed recovery or macular swelling or These cells that have completed cataract removal may cause cystoid macular edema. Complete removal predicts a better postoperative outcome.
[0123] In one embodiment of the present invention, the device may include attachments other than a camera, such as forceps or scissors. The system can be equipped with a 3D touch screen, allowing the surgeon to perform tasks under direct visualization. This can be achieved by suturing with a capsular tension ring or secondary IOL, and by attaching the capsular The water jet system maintains pressure and releases the IOL from the implant. This may eliminate the need for viscoelastics in some procedures. Centered by arms or haptics that project into the capsular support region of the capsular connector How the IOL sits in this zone has not yet been visualized. According to the sense of touch, under direct observation, they are optimally placed in the appropriate and most powerful position. In addition, the folded tissue planes of the capsular bag can be separated. If an IOL must be removed, haptics provide a much safer and more controlled procedure. In some cases, the ciliary zonules are weak and tear away from their ciliary attachment. In these cases, a ring can be placed within the capsular bag to equalize stress around the injured bag. Direct visualization of the rings and areas requiring support is essential in these cases. At the same time, the sutures may be placed to attach them to the sclera. or attach a tactile "elasticity." Under direct observation, this procedure The procedure is then optimized again. If two hands are required, the surgeon can use both hands to suture or knot. During this time, the device may be stabilized in a position to view the area of interest.
[0124] In one embodiment of the present invention, the volume of fluid required to be projected from the tip of the device is reduced. The lens is shaped to allow for safe hydrodissection of the lens tissue from the capsule. This can be controlled via a foot pedal or from the handpiece itself. An example of such an embodiment of the tool is shown in FIG. Various buttons, levers and valves are shown integrated into the tool and are described herein. The flow rate and other parameters are controlled based on the requirements of the task and the surgeon. Flow may be adjusted according to task requirements and at the discretion of the surgeon. The frequency and intensity of the pulses can therefore be varied according to the external The frequency of the pulsation may be set by a physician. It can be at a low rate of 1 pulse per second, or it can be as fast as 10 pulses per second or more. Additionally, the fluid flow rate and pulsation rate can be varied independently. By varying the flow rate and pulse rate, the device can mitigate the effects of the experience and the opposing tissue. The pulsation rate can be controlled in different ways. The valve may interfere with the movement of the pump in the flow line or handpiece. Such methods are within the skill of those in the art of fluid flow. This is well understood by those skilled in the art and the above examples are not limiting.
[0125] FIG. 17 illustrates another embodiment of the invention showing the simultaneous use of two devices. 7 is a camera and irrigation probe operating in parallel with a light probe 172 within a human eye 170. 171 combination is shown diagrammatically. Typically, one or two incisions less than 3 mm (usually Two incisions (called "primary" and "secondary" incisions) are made in the eye during surgery. The device is adapted to seal the incision and maintain pressure within the eye during surgery. The two incisions allow two separate instruments to be used simultaneously during surgery. For purposes of illustration only, the two devices may have many different combinations of features. The tool can incorporate a camera and irrigation tool inserted into a single incision, The second tool can incorporate an illumination probe. We will understand the utility of the approach and consider other combinations of features for both tools. For example, light irradiation (of any wavelength), laser, irrigation, scraping, etc. The imaging elements, cameras, and others can be integrated into any tool in any combination. The unique miniaturized nature of the present invention allows for such a combination of features, making it ideal for ophthalmic surgery. This gives professionals the flexibility they need to operate optimally.
[0126] FIG. 18 demonstrates the miniaturization capabilities of a medical ophthalmic device as well as the different components / units. The handpiece 1 is connected to an endoscope unit via a suitable connector 2. The endoscope unit 3 is connected to a video controller 4. Features: White light balance and light intensity controller, photo shooting still and / or In addition, irrigation adjustment and control may include, but is not limited to, , may be provided via this unit or may be included in a separate unit. The endoscope unit supports HDMI (registered trademark), DVI, composite, S-Video and U This implementation is compatible with all electrical connections such as, but not limited to, this list. In one embodiment, the probe comprises various components integrated at the distal end of the probe unit. In this embodiment, the optical barrel 5 is constructed from two or more lenses, each of which may be adapted for a particular application. Therefore, any aspect of the illumination (e.g., intensity, frequency / wavelength, temporal light interruption, waveform, etc.) can be controlled. Any number of filters and / or coatings may be included to control The sensor housing 6 and the optical barrel 5 are integrated according to the optical requirements of the particular procedure. The sensor 7 may be wafer-based, i.e., the camera, the sensor and the optical barrel can be integrated / assembled or the optical components can be integrated into the sensor itself. separated from the body, the focusing lens is adjusted by changing the distance between their surfaces, More conventional methods can be used. One or more LEDs 8 are The light source is integrated into the distal end of the probe device on a circuit board 9. The light can also be provided by an optical fiber from the probe to the distal end of the probe. The surface and the distal surface of the optical barrel are flush with each other, further conserving volume space and making the device compact. The LED 8 can be placed on the same PCB as the sensor 6. In addition, the camera can also work without illumination, and such an option is available for high-resolution This may be important for further miniaturization of devices for precision surgery. In the option without the illumination feature, the probe is space-saving and subsequently miniaturized. This allows us to work with cameras on a much smaller scale. Larger chips can be used to provide higher resolution due to aperture requirements. A cable 18 runs from the distal end of the probe, where many of the functional components are located, to the handpiece. The cables connect all the features throughout the device, to the instrument and to the external measurement unit. Instead, a flexible PCB design can be implemented. The PCB is mounted at a 90 degree angle. Alternatively, two PCBs can be used. The cable 18 is connected to the video controller 4 in the endoscope unit 3. A type video controller can be located on the handpiece itself and integrated into the device.
[0127] According to one embodiment of the invention, the tip of the probe is adapted to view under the incision and Rotation in the left or right zone of interest allows the probe to be bent into a U-shape. In this embodiment, the probe support is made of metal or polyamide. The tubing is made from a compatible material such as mide.
[0128] The probe can be rotated in one or two directions by pulling the cord laterally. The probe may have lateral support cords to allow it to be rotated. Circular rotation and the ability to bend the tip allows the probe to be pointed in any direction required. The relatively small space for minimal bending and rotation within the eye allows for any desired orientation. The tip can be oriented as shown.
[0129] The optical design of a complete objective depends on several parameters, e.g., field of view (FOV), target Depth of field (DOF), pixel size, effective area of the sensor, and overall solid sensor camera head Consider the orientation of its optical axis relative to the mechanical axis of the If the two axes are not coincident, the mechanical parts and / or the assembly The shift of the assembly must be taken into account, or in the case of aspheric lenses, the mold for the lens must be Other parameters also affect the design. For example, For example, the level of distortion and the F-stop. If the distortion is too high, a "fish-eye" effect appears, and if the F If the value is too high, more lighting is needed to get a bright image. Software-driven magnification can allow for the enlargement of the region of interest. Alternatively, the use of OCT allows for views through tissue planes when deemed necessary. The present invention may be used in conjunction with a device to provide
[0130] In one embodiment of the present invention, the probe is attachable to a medical ophthalmic device. Thus, according to this embodiment, the device is reusable, i.e., sterilized and can be used in subsequent procedures. On the other hand, the visualization probe is disposable and can be used for a long time. This may be done in order to manufacture an embodiment of the visualization probe according to the invention. This can be achieved at low cost by using the methods described in the literature. For cutting tips, cataracts, or for manipulating grafts or MIGS insertion Examples of side port probes include those used to attach to instruments.
[0131] In another aspect, the present invention provides an imaging device having an outer diameter of, for example, about 1.8 millimeters or less. A medical ophthalmic device having a socket or channel suitable for receiving a visualization probe having In such devices, the socket receives the signal generated by the probe. and a signal transfer connector configured to receive the signals and transmit them to the display device. stomach.
[0132] As used above, the term "medical ophthalmic device" refers to any device that is actively used on the human or animal eye. devices used solely for diagnostic purposes, as well as devices used to perform surgical procedures It also refers to devices used in treatment and / or drug delivery. Any device that is imported into the U.S. is included in the definition of a medical device throughout this specification. The therapeutic ophthalmic device is selected from the following: endoscope; scissors; scalpel; laparoscope; treatment For procedures or to insert and use other devices through these tubes (or pipes) Flexible, semi-flexible, semi-rigid, or single-tube catheters used to protect the eye during extraction. Single or multiple lumen tubes (or pipes); springs; rods; tissue connecting devices Devices used to close, cut, and seal; burn, solidify, or or otherwise destroying; feeding, directing, ejecting or Devices for delivering; guidewires, forceps, monitoring and / or diagnostic devices; wireless In vivo devices, etc.
[0133] The present invention further includes the combination of a medical ophthalmic device and the visualization probe described above. For example, the solid-state imaging device may be mounted at the distal end of a visualization probe attached to the surface of a medical ophthalmic device. can be placed.
[0134] The object of the present invention is to provide a method for the preparation of visualization probes of very small size and medical devices containing them. and manufacturing a medical ophthalmic device utilizing the techniques described hereinabove. Thus, this was achieved.
[0135] It will be apparent to one skilled in the art that all of the above descriptions and examples are provided for illustrative purposes only. The present invention is not intended to limit the scope of the present invention in any manner. The probe can be used to create many different surgical tools; and Many such different tools can be made. These tools are in accordance with the present invention. The probe is provided with a socket adapted to receive the probe, and is adapted to connect various tools and their The probes may be adapted to receive the probes in various suitable and convenient locations according to the procedure for using the probes. The present invention therefore provides a socket adapted to the shape, position of the probe, and and, without being limited to their intended use, medical devices, in particular medical ophthalmic devices. Opening the door for a new generation of probes. Also, the ability to "mount" probes without a housing. Alternatively, it is possible to mount a probe that already includes a housing within the tool.
Claims
1. A medical ophthalmic endoscope device comprising an endoscope having at least one camera, the at least one camera sensor is centrally located at a distal end of the endoscope; the endoscope having one or more illumination sources and one or more openings for irrigation or sweeping disposed about the sensor; The medical ophthalmic endoscope device has an outer diameter of about 1.8 mm or less.
2. 10. The medical ophthalmic endoscopic device of claim 1, wherein the medical ophthalmic endoscopic device is configured to be inserted through an incision made around the cornea of a patient's eye during cataract surgery and / or minimally invasive glaucoma surgery (MIGS).
3. The medical ophthalmic endoscopic device of claim 1 or 2, wherein the medical ophthalmic endoscopic device is configured to be inserted through a trocar.
4. The medical ophthalmic endoscopic device of claim 1 , wherein the one or more illumination sources include one or more LEDs.
5. The medical ophthalmic endoscopic device of claim 1 , wherein the one or more illumination sources comprise one or more optical fibers and / or light guides.
6. The medical ophthalmic endoscopic device according to any one of claims 1 to 5, comprising one or more phacoemulsification tools or tools for removing lens cells under direct vision.
7. The medical ophthalmic endoscope device of claim 6 , wherein the tool for removing lens cells under direct vision is an irrigation tool, an aspiration tool, or a combination thereof.
8. The medical ophthalmic endoscopic device of claim 7 , wherein the irrigation tool and the suction tool are integrated in concentric circles, one disposed in an inner circle and the other disposed in an outer circle, or disposed adjacent to each other.
9. A medical ophthalmic endoscopic device according to any one of claims 1 to 8, comprising a handpiece and a flattened distal end.
10. The medical ophthalmic endoscope device according to any one of claims 1 to 9, wherein the camera is rectangular and the endoscope is circular.
Citation Information
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