GB2551102A

GB2551102A - System and method for image guided insertion of intraocular devices for control of Intraocular pressure and other intraocular diagnostic and interventional

Info

Publication number: GB2551102A
Application number: GB1605700.2A
Authority: GB
Inventors: Gerard Rohan Jayamanne Don
Original assignee: Individual
Current assignee: Individual
Priority date: 2016-04-04
Filing date: 2016-04-04
Publication date: 2017-12-13

Abstract

An apparatus and method for medical diagnoses and interventions inside the eye may comprise an imaging devices and an expandable, extendable or retractable member for cutting or inserting into an eye or organ of sight. Retractable members may include stents, glaucoma drainage devices, intraocular pressure reducing devices, tissue cutting devices, intraocular devices and drug delivery systems. They may be used to investigate or operate inside the chambers of the eye, the anterior chamber of the eye, posterior chamber of the eye, the anterior chamber angle or the trabecular meshwork. Imaging devices may include optical image capture devices, ultrasound transducers or optical coherence tomography (OCT) fibers. They may assist with navigation of relevant tools in use. The imaging devices may be placed on the surface of the eye or inserted into the eye through a small incision or the imaging device may be a part of a device or attached to a device inserted into the eye through a small incision.

Description

Field of the Invention

The present invention relates to diagnostic and/or interventional visualization of ocular tissue during intraocular surgery in particular glaucoma surgery, anterior segment ocular surgery or posterior segment ocular surgery, and particularly to the utilization of various imaging devices, expandable, extendable, retraction, insertion and cutting devices coupled for improved visualization, navigation, access and guidance during diagnostic and interventional procedures.

Background of the invention

Many thousands people undergo glaucoma procedures every year. Glaucoma is an eye disease that damages the optic nerve. If left untreated, glaucoma can lead to blindness. One of the proven way to combat glaucoma is by lowering patients' intraocular pressure (IOP). IOP is the fluid pressure inside the eye. The fluid is produced inside the eye and exits the eye through a structure called the trabecular meshwork into a canal and then into a group of veins. Referring to Figure 1, some elements of the anatomy of the anterior chamber of the eye (101) are represented, including the cornea [the front window of the eye] (102), iris (103), trabecular meshwork [drain inside the eye] (104) and canal of schlem (105). The trabecular meshwork and the canal complex is sometimes referred to as the drainage angle of the eye or the angle of the anterior chamber of the eye or the iridocorneal angle (106). The trabecular meshwork is an area of tissue in the eye located around the base of the cornea (104). The path followed by the fluid produced in the eye is shown by the thick broken line (107).

Glaucoma can be treated with eye drops, oral medication, laser surgery, traditional surgery, stent techniques or a combination of these methods. The aim of the treatment is to prevent loss of vision, as vision loss from glaucoma is irreversible. With early detection and treatment with medical and/or surgical treatment, most people with glaucoma will not lose their sight.

Topical eye medications are effective in reducing IOP by reducing the production of the fluid. Some patients struggle to use drops regularly enough to control their IOP.

When medications do not achieve the required results, or have side effects, laser surgery or traditional surgery may be carried out on an individual patient.

The laser beam is focused upon the eye's drainage angle structures (106). The drainage system is changed in very subtle ways so that fluid is able to pass more easily, thus lowering IOP.

Laser beam can also be used to make an opening through the iris (103), allowing the fluid to flow from behind the iris directly to the anterior chamber of the eye. This laser is most often used to prevent certain forms of glaucoma attacks.

Laser procedures can reduce the amount of fluid in the eye by destroying the part of the eye known as the ciliary body (108), which produces the fluid.

Traditional glaucoma surgery is recommended when medications and laser surgery do not adequately lower IOP. A flap is created to allow fluid to escape, without deflating the eyeball. The body may try to heal this new opening, and therefore, surgery may fail in a certain percentage of patients.

Drainage implant surgery has been developed to help some patients with glaucoma. Several different devices have been developed to help the drainage of fluid and lower IOP. In most of these devices, a small tube extends into the anterior chamber of the eye. The tube is connected to one or more plates. Fluid is collected on the plate and then absorbed by the eye.

Several new surgical approaches have been developed with the aim to reduce complications associated with conventional glaucoma surgery. Each approach makes use of a specific strategy to reduce the pressure within the eye. A mini-shunt can be used with conventional surgery techniques to standardize the operation and reduce the chances of the eye pressure getting too low immediately after the surgery. Another technique is a device which removes tissue from the trabecular meshwork (104) using a handpiece that disrupts the tissue. A technique that involves the dilation of the entrance to the outflow pathways in the wall of the eye [canal of schlem] (105) is another newer procedure described to reduce the pressure in the eye.

Tiny drainage devices have been invented to be placed in the drainage angle of the eye (106) or in the trabecular meshwork (104) to help with the drainage of the fluid of the eye.

Referring to Figure 2, a tiny drainage device is introduced into the eye via a small incision using a simple injector (201). These devices have been shown to reduce IOP in certain individuals with glaucoma. Accurate placement of these designs are important to help with the functioning of the devices. Currently, the devices are placed inside die eye with the aid of a contact lens (202) placed on the front window of the eye (cornea) during the surgery. The drainage angle of the eye would be viewed through the contact lens and the operating microscope. The device would be placed in the desired place and checked for accurate placement during the post-operative period by scanning the eye after surgery. It would be desirable to have tools that have imaging capabilities at the time of the insertion of the intraocular devices to ensure accurate placement of glaucoma drainage device peri-operatively rather than post-operatively. Further, it would be valuable to have a tool, typically with one or more imaging fiber bundles to transmit captured signals where they may be digitised for the surgeon to view the images prior to completing the surgery. There are such tools available for surgeons performing other types of surgery.

Description of the Invention

For the purpose of the invention, the term “eye” refers to the organ of sight. The term “ intraocular” refers to inside of the eye or eyeball and “ophthalmic” means pertaining to the eye.

It is desirable in many intraocular interventional settings for example insertion of glaucoma drainage devices, intraocular devices or retinal procedures to optimise the surgery by performing peri-operative intraocular imaging techniques such as optical coherence tomography (OCT). Traditionally, intraocular surgery is performed by using an operating microscope with built in imaging devices and if required the use of additional contact lenses. Currently, post-operative imaging modalities such as ultrasound and anterior segment OCT is used to localise the placement of intraocular pressure reducing devices such as stents. It would be ideal to have an imaging modality at the time of surgery ( peri-operative) to identify the exact position of the intraocular devices so that unintentionally misplaced devices can be placed in the correct location at the time of surgery reducing the need for further surgery as well improving patient outcome.

An apparatus and method for conducting an intraocular ophthalmic intervention or diagnosis, comprising an elongate trocar member. In its simplest form, a trocar is a penshaped instrument with a sharp triangular point at one end, typically used inside a hollow tube, known as a cannula or sleeve, to create an opening into the body through which the sleeve may be introduced, to provide an access port during surgery.

Referring to Figure 3, sharp triangular point (301) and cannula or sleeve (302) is shown with a lumen. The elongate trocar member may be available in any length or any diameter. The elongate trocar member may comprise an outer housing assembly, a sleeve that fits inside the housing assembly and a piercing stylus which slots into the sleeve such that the tip protrudes from the lower end of the instrument. The housing assembly may be connected to a handle ( or barrel) to help the person holding the elongated trocar member hold the device steadily during intraocular surgery. The handle (or barrel) may be any size or shape.

Referring to Figure 4, the housing assembly (401) and the handle or barrel (402) is shown with a syringe plunger like design (403). The handle may be a simple barrel like design without a plunger. Plunger like design or barrel like design functions as a portal for subsequent placement of other devices/instruments via the handle. Plunger if present may be removable. The trocar functions as a portal for subsequent placement of other instruments/devices such as an imaging device, cutting device, intraocular device or stent. A classical trocar has 'three point' design that gave them their name. The elongate trocar member in the present invention may have a three point design, a flat bladed 'dilating-tip' product, or be entirely blade free design. The blade free design is introduced inside eye through a small incision in the eye made by a sharp instrument.

Referring to Figure 5A, 5B and 5C, the elongate trocar member having proximal and distal ends (501), longitudinal axis and defining a first working lumen (502) thereby, and a controllably expandable distal member paired or coupled to the distal end of the elongate trocar member and put together to be expanded from a collapsed state or a folded state or a state where the distal member is stored in the protective housing of the first working lumen or it’s housing or it’s handle and extends outside of the lumen, housing or handle for use (503), wherein the expandable distal member has an outer diameter having a resemblance in appearance to that of the trocar member, to an expanded state, wherein the expandable distal member has an outer diameter that may be larger than that of the trocar member or the expandable distal member may have an outer diameter that may be smaller than that of the trocar member. The expandable distal member may expand in any two dimensional ( horizontal or vertical) or three dimensional plane with an addition of any direction of movement (for example rotation of movement resembling a fourth dimension). Mechanism of action required to extend the expandable distal member may be any mechanism required to push out the expandable distal member and retract or pull back the expandable distal member (504). The expandable distal member or the elongated trocar member may have a sharp edge similar to a needle or knife. The expandable distal member may be designed to deliver a device such as an implantable stent, intraocular pressure reducing device, glaucoma drainage device, intraocular device or drug delivery system of any size or shape. Mechanism of action required to deliver a device may be any mechanism required to push out the device through the expandable distal member or the elongate trocar member and retract or pull back the expandable distal member. The apparatus further consist of an image capture device coupled to the elongate trocar member or it’s housing or it’s handle and arranged to have a field of view spread out away from the distal end of the elongate trocar member (505) and at least partially in alignment with the longitudinal axis of the trocar member. The image capture device may comprise an optical imaging device. The image capture device may comprise an optical coherence tomography (OCT) imaging fiber(s). The image capture device may comprise an ultrasound transducer. The image capture device may comprise of a combination of an ultrasound, an optical coherence tomography imaging fiber(s) and/or an optical imaging device. The elongate trocar member, it’s housing or it’s handle may have an image capture device as described above in isolation without a delivery system to insert an implantable stent, glaucoma drainage device, intraocular pressure reducing device, intraocular device or drug delivery system or any additional lumens. The elongate trocar member with the image capture device may be used before, during or after any intraocular surgery.

The embodiment is depicted in Figure 6 wherein, the image capture device such as the ultrasound transducer, the optical coherence tomography imaging fiber(s) or the optical imaging device ( or a combination of the image capture devices) may be introduced or attached via an opening of the trocar member, in the housing attached to the elongated trocar member or the handle attached to the elongated trocar member, once the delivery system has introduced implantable stents, glaucoma drainage devices, intraocular pressure reducing devices, intraocular or the drug delivery systems. Hunger like design or barrel shaped design may function as a portal (601).

The embodiment is depicted in Figure 7 wherein, once a glaucoma stent or glaucoma drainage device, intraocular pressure reducing device, intraocular device or the drag delivery system is placed in the eye (701) or intraocular surgery is completed, the elongate trocar member with the image capture device is introduced inside the eye (702) via a small incision in the anterior or posterior chamber of the eye to help determine the accurate placement of the device or apposition of the anatomy (703).

The embodiment is depicted in Figure 8 wherein, the elongate trocar member may be essentially stiff and may have a structural shape arranged to maintain a shape more or less similar to an unloaded configuration of the trocar member when navigated through ocular tissue. The controllably expandable distal member may contain the intraocular device or the intraocular pressure reducing device such as an implantable stent, glaucoma drainage device and/or a drug delivery system (801). The housing or the handle of the trocar member may contain the intraocular pressure reducing device such as an implantable stent, glaucoma drainage device and/or the drug delivery system or the intraocular device. The apparatus further consist of an image capture device coupled to the end of the elongate trocar member, it’s housing or it’s handle that contains the intraocular pressure reducing device such as an implantable stent, glaucoma drainage device, intraocular pressure reducing device, intraocular device or the drug deliveiy system and arranged to have a field of view spread out away from the distal end of the elongate trocar member and at least partially in alignment with the longitudinal axis of the elongate trocar member, wherein the field of view of the image capture device records a substantial portion or the whole of the area where the intraocular pressure reducing device such as an implantable stent, glaucoma drainage device, intraocular pressure reducing device, intraocular device and/or the drug delivery system can be placed within the eye or any other part of the eye or orbit. The image capture device may comprise an optical imaging device. The image capture device may comprise an optical coherence tomography imaging fiber(s). The image capture device may comprise an ultrasound transducer (802). The image capture device may comprise a combination of the image capture devices as described above. The expandable distal member may comprise a flexible cuff (803). The flexible cuff may show inclination to self expand to the expanded state when not restrained in the collapsed state. The elongate trocar member may further consist a transparent fluid to wash away debris from the field of view or to cool the trocar member. The elongate trocar membrane may be in a housing or may be covered with material to enable safe use of an image capture device inside the eye. The controllably expandable distal member may comprise one or more cutting elements designed to tear and cut nearby tissue structures. At least one of the one or more cutting elements may become prominently exposed when the controllably expandable distal member is in the expanded state. The cutting element may be a permanent part of the elongated member inserted into an eye via a small incision. The cutting mechanism may be mechanical, thermal, electrical or any other method. The controllably expandable distal member may be expanded by any process that exerts any type of force or energy to any part of the trocar member, expandable distal member or any part of the housing unit, or handle in which the trocar member or expandable distal member or any other component may be held.

Configurations and techniques are described herein for improving the imaging of intraocular structures during intraocular diagnostic and interventional procedures, such as glaucoma surgery, surgery of the anterior segment of the eye or posterior segment surgery of the eye.

Referring to figure 9, after preoperative preparation of the patient and the eye, corneal incision is made using a sharp instrument such a needle or knife. Usually, the corneal wound is self sealing. The needle or knife tip may be part of the distal end of the elongated trocar member or part of a retractable instrument inside the lumen of the elongated trocar member ¢901). The self sealing corneal incision is usually made under the guidance of an operating microscope. The distal tip of the elongate trocar member is inserted through the corneal wound into the anterior chamber of the eye. This is carried out under the guidance of an operating microscope. The distal tip of the elongate trocar member is advanced across the anterior chamber. Usual position is immediately adjacent to anterior chamber angle of the eye. The elongate trocar member may be utilized to guide a separate extendable/expandable/retraction trocar or member into the anterior chamber via an “ over a wire” or “thread through” form. The expandable/ extendable/retraction distal trocar member may have a needle like or knife like edge. Within the separate extendable/expandable/retraction trocar member, an apparatus may consist of an image capture device. Within a lumen of the trocar member, an apparatus may consist of an image capture device. Within the housing or handle of the trocar member, an apparatus may consist of an image capture device (902). The trocar member may be connected to an image capture device and display. The image capture device may comprise an optical imaging device. The image capture device may comprise an optical coherence tomography imaging fiber(s). The image capture device may comprise an ultrasound transducer. The image capture device may comprise a combination of the image capture devices as described above. The image capture device may be permanently or temporarily attached.

Referring to Figure 10, the image capture device (ultrasound system, optical coherence tomography system, optical imaging system or combination of systems) may be housed separately (1001) to the elongated trocar member, it’s housing or it’s handle or the loaded device containing the implantable stent, glaucoma drainage device, intraocular pressure reducing device, intraocular device or drug delivery system and connected to the elongated trocar or it’s housing or it’s handle or the device containing the implantable stent, glaucoma drainage device, intraocular pressure reducing device, intraocular device or drug delivery system or it’s housing or it’s handle via any temporary or permanent method either before, during or after the introduction of the implantable stents, glaucoma drainage devices, intraocular pressure reducing devices, intraocular device or drug delivery systems into the eye.

Suitable elongate trocar members may be substantially rigid to be configured to have a structural modulus configured to maintain a shape substantially similar to an unloaded configuration of the trocar member when passing through ocular tissue. The depicted elongated trocar member may consist an expandable member, such an expandable cuff, cutting device or a loaded device for a stent, glaucoma drainage device, intraocular pressure reducing device, intraocular device or drug delivery system. The expandable member may be of any shape (ie, elliptical, spherical, donut shaped, conically shaped and may have a substantially rounded outer shape). An expandable cuff may be flexible or substantially rigid. It also may be expandable, such as a ballon, or self expanding (ie, biased to self expand to an expanded configuration when not restrained in a collapsed configuration). The trocar member may comprise a lumen which may be loaded with a glaucoma drainage device, intraocular pressure reducing device, stent, intraocular device or a drug delivery device. The trocar member may comprise a lumen which may be loaded with a fluid.

In the depicted embodiment, Figure 11, the trocar member comprises an expandable distal member loaded with a glaucoma drainage device, intraocular pressure reducing device, stent, intraocular device or drug delivery system (1101). The trocar member may comprise an inflation lumen which may be fluidly or solidly coupled to an associated inflation type or pushable expandable/extendable/retraction member (1102). The member may consist of a suitable expandable/extendable/retractable members configured for minimally invasive delivery during intraocular surgery. Extendable/ expandable/retractable members, and other members may have a lubricated coating to enhance smooth movement relative to other tissues. Expandable/extendable/retractable members may be textured or may contain surface texturing configured to provide traction relative to tissues or other instrumentation. The expandable/extendable/ retractable members may be controllably expanded or used to bring a small operating space from what previously was only a potential space for insertion of a stent, glaucoma drainage device, intraocular pressure reducing device, intraocular device or drug delivery system. By further expansion of the expandable/extendable/retractable member, a larger surface of the operating area may be exposed. With an adequate exposure of the surgical field, interventional tools such as stents, glaucoma drainage devices, intraocular pressure reducing devices, intraocular devices or drug delivery devices or diagnostic devices may be placed in the correct anatomical position under direct visualization of an image capture device which may be disposed adjacent the apex of the expandable/extendable/retractable member or may be housed in a separate lumen or within the housing or handle of the trocar member (1103). The expandable/ extendable/retractable member may be reduced in size, after which it may be removed.

Referring to Figure 12A, a guide wire (1201) may be inserted through the lumen of the trocar or it’s housing or it’s handle to help with further advancement of relevant diagnostic or interventional devices. The guide wire may have a needle tip or a sharp tip. The needle tip or sharp tip may be used to create a perforation in the expandable member prior to advancement of relevant diagnostic or interventional devices. Diagnostic or interventional devices such as stents, glaucoma drainage devices, intraocular pressure reducing devices, intraocular devices or drug delivery systems may be at least partially advanced over or through the needle tip or sharp tip into the relevant anatomical site within the ocular tissue. It may be possible to have two discreet tools advanced through two different working lumens of the elongated trocar member, (1202) to facilitate tissue manipulation and device insertion. There may be one, two or more lumens within the main body of file trocar member, it’s housing or it’s handle.

An instrumented needle or sharp tip ( with it’s housing and/or it’s handle) or other elongate guiding member with an image capture device may be used to navigate pertinent anatomy and instrumentation. The instrumented needle design having a similar look to a needle, hub and syringe appearance with an image capture device build into or attached to the needle trocar member, it’s housing or it’s handle. The image capture device on the instrumented needle may comprise an optical imaging device. The image capture device may comprise an optical coherence tomography imaging fiber(s). The image capture device may comprise an ultrasound transducer. ( or a combination of imaging devices). The instrumented needle with the image capture device may have a retractable, removable or disposable needle tip, permanent sharp tip or may have a blunt tip design. The instrumented needle with the image capture device described above may have a housing unit and a handle for ease of use by the user. The shape of the instrumented needle and housing unit may resemble a syringe, needle and hub.

Referring to Figure 12B, an ultrasound transducer, optical imaging device or an optical coherence tomography imaging fiber(s) or a combination of the above with a field of view orientated towards tissue structure and interventional/diagnostic tools of interest may be used intraoperatively during intraocular surgery to visualise, navigate and guide the tools and devices relative to relevant anatomy.

One embodiment of an instrumented needle (1203) or other elongated guiding member is illustrated wherein the ultrasound transducer, optical imaging device or an optical coherence tomography imaging fiber(s) may be utilized with a generally forward orientated field of view to image nearby structures. Roll or rotation, extension or retraction or any movement of the instrumented needle or blunt tip or elongated guiding member may be used to capture the image within the field of view over a period of time. An optical/OCT fiber(s) may be utilized for OCT imaging. The OCT fiber(s) is proximally coupled to an OCT system to build up clear 2D and 3D images and movies of ocular structures. The ultrasound transducer may be operatively coupled to an ultrasound system. The optical imaging device may be coupled to the relevant receiver systems. Each of these subsystems may be coupled with various electrical/connecting leads to the control/display interface module of the system (1204). An image printing device may be connected to the control/display interface module of the system.

Referring to Figure 13A and 13B, a trocar with expandable distal tip is depicted with a needle or sharp tip positioned through it’s working lumen. In practice, the needle tip or knife like sharp tip may be used to insert the elongated trocar into the eye (1301), and the needle tip or the sharp tip may be retracted through a lumen (1302). An imaging device such as an optical image capture device, ultrasound transducers and optical coherence tomography fiber(s) or a combination of imaging devices (1303) may be inserted through a lumen or attached to the housing or handle of the elongated trocar to view ocular structures. The image capture device may be left in a lumen within the trocar member, the housing or the handle of the elongated trocar member or within the tip of the trocar member and fixed to the housing or the handle to continuously image the ocular structures or removed once an image is obtained. Any temporary or permanent method or force may be used to fix the image capture device to the trocar, it’s housing or it’s handle. The image capture device may be removed and reattached from the body of the housing or the handle of the elongated trocar member (1304). The image capture device may be removed and reattached from the elongate trocar member.

Referring to Figure 14, an image capture device such as an OCT fiber(s), optical imaging device or ultrasound transducer(s) or a combination of devices may be build into a needle tip or knife like device with a sharp tip or a blunt tip probe for insertion into the eye during intraocular surgery through a small incision (1401). The sharp tip of the needle or knife like device may be retractable and/or removable after insertion into the eye and separated from the image capture device. An image capture device described above may be accommodated or connected to the housing unit and/or the handle for ease of use or ease of insertion into an eye by the surgeon through an entry port. The image capture device may be removed and reattached from the body of the housing or the handle or from the lumen of the trocar member (1402). Any method of fixation or force may be used to attach the elongated trocar member, it’s housing or it’s handle with the image capture device. Any method of fixation or force may be used to attach the needle, the probe or the sharp tipped device with an image capture device to the eye ( ie suction, suture or self retaining by the accurate construction of wound architecture etc). By placing the image capture device on the eye to continuously image the intraocular anatomy, the stents, glaucoma drainage devices, intraocular pressure reducing devices, intraocular devices or drug delivery systems can be introduced inside the eye by direct visualisation. The stents, glaucoma drainage devices, intraocular pressure reducing devices, intraocular devices or drug delivery systems may be inserted via a second port of entry separate from the port of entry of the image capture device.

Referring to Figure 15, the image capture device may be void of a sharp tip or blunt probe and be accommodated in the body of the housing with or without a handle (1501). The image capture device (ultrasound system, optical coherence tomography system, optical imaging system or combination of systems) may be held on or near the surface of the eye by the operator to obtain images of the eye before, during or after insertion of the stents, glaucoma drainage devices, intraocular pressure reducing devices, intraocular devices or drug delivery systems.

Referring to Figure 16, an expandable/extendable/retractable member ( such as a cutting device) may be introduced through a second separate lumen of the elongated trocar member (1601) to enable the operator to prepare the ocular tissue prior to insertion of a stent, intraocular pressure reducing device, glaucoma drainage device , intraocular device or a drug delivery system. A fluid reservoir with a substance such as balanced solution or fluid delivery system to deliver a visco-elastic material may be used to keep the image clear and free of debris. The working lumen(s) of elongate trocar member or an instrumented needle or probe may be instrumented with an image capture device, such as an OCT imaging fiber(s), ultrasound transducer or optical imaging device as well as an illumination source, and an irrigation head. An aspiration port for evacuating fluids, tissue, or other substances may be present within a working lumen of the elongate trocar member.

Referring to Figure 17, in one embodiment, the design of the elongated trocar member with the image capture device and the delivery system for a glaucoma drainage device, intraocular pressure reducing device, stent, intraocular device, drug delivery system or cutting device, or the needle shaped image capture device with a needle tip or a sharp knife like tip or a blunt probe tip may have a design that aids it’s fixation to the entry wound making it stable to aid image capture (1701). The fixation method such as suction or a suture, self retaining due to wound architecture or any other method may be used. A special knife or similar sharp instrument may be designed to construct the accurate wound architecture to help the design of the elongated trocar member with an image capture device and the delivery system for a glaucoma drainage device, stent, intraocular pressure reducing device, intraocular device, drug delivery system or cutting device, or the needle shaped image capture device with a needle tip or a sharp knife like tip or the blunt probe tip fixate on the eye.

Referring to Figure 18, a pre-loaded injector with a stent, intraocular pressure reducing device, glaucoma drainage device, intraocular device or a drug delivery system (1801) may have a lumen, hole, chamber or housing to introduce, attach or hold an image capture device (1802) such as an optical image capture device, ultrasound transducers, optical coherence tomography fiber(s). The image capture device may have an illumination source. The image capture device may be used to continuously image the eye whilst the stent, intraocular pressure reducing device, glaucoma drainage device, intraocular device or the drug delivery system is correctly placed in the correct anatomical location or the image capture device may be used to image the eye after the introduction of the stent, intraocular pressure reducing device, glaucoma drainage device, intraocular device or the drug delivery system. The image capture device may be permanently or temporarily attached to any part of the pre-loaded injector or any of it’s attachments (1803).

An apparatus and method for performing a procedure, conducting minimally invasive medical diagnoses and interventions inside the eye utilising instruments and assemblies incorporating various of the above configurations and/or steps and/or designs are illustrated. After pre-operative assessment of the patient, it is decided by the physician to intervene with an intraocular procedure. The patient preparation is competed in an operating room, a corneal incision is made using a sharp instrument such a needle or knife. Usually, the comeal wound is self sealing. The needle or knife tip may be part of the distal end of the elongated trocar member or part of an expandable/extendable/ retractable instrument inside the lumen of the elongated trocar member. The needle tip or sharp tip may be part of a needle tip type image capture device with a retractable, removable or fixed sharp tip. The self sealing comeal incision is usually made under the guidance of an operating microscope. Once the comeal wound is made, the elongated trocar member with the image capture device and an expandable/extendable/retractable member and a lumen for a glaucoma drainage device, stent, intraocular pressure reducing device, tissue cutting device, intraocular device or a drug delivery system or the image capture device such as an OCT fibers), optical imaging device or ultrasound transducers) built into a needle tip or knife like device with a sharp tip ( with fixed or retractable sharp tip) or a blunt tip probe is inserted into the eye. The apparatus described above is advanced inside the eye. With the use of the imaging modalities in the apparatus described above such as OCT, ultrasound or an optical imaging device, intraocular structures will be visualize by the surgeon peri-operatively.

The image capture device such as an OCT fiber(s), optical imaging device or ultrasound transducer(s) built into a needle tip or knife like device with a sharp tip (with a fixed or retractable sharp tip) or a blunt tip probe may be left in situ held in place in the comeal wound or the eye by the construction of the wound architecture or by any other method. With such imaging, the surgeon is able to get direct visualization of ocular structures during insertion of a glaucoma drainage device, a stent, an intraocular pressure reducing device, tissue cutting device, intraocular device or a drug delivery system. In this embodiment, the glaucoma drainage device, the stent, the intraocular pressure reducing device, the tissue cutting device, intraocular device or the drug delivery system is introduced through a second comeal wound with direct visualization of tissues using the image capture device as described above. With such visualization, accurate placement of a glaucoma drainage device, a stent, an intraocular pressure reducing device, tissue cutting device, intraocular device or a drug delivery system can be achieved.

In another embodiment, elongated trocar member with a portion of the trocar for example, an expandable member, and a repositionable mechanical element may be utilized to prepare intraocular tissue for implantation of a glaucoma drainage device, a stent, an intraocular pressure reducing device, tissue cutting device, intraocular device or a drug deliveiy system with direct visualization using an image capture device. Interventional or diagnostic tools may be brought into the eye for tissue manipulation purposes. Tools such as micro-scissors, graspers that are remotely controllable tools.

The method and apparatus described above where various changes may be made to the invention described above without departing from the true spirit and scope of the invention. Modification may be made particular to the material used to manufacture the apparatus described above, composition of the material, possess of manufacture and storage. Each embodiment may be disposable or reusable. Any part or parts of each embodiment may be disposable or reusable. Any part or parts of each embodiment may be retractable or removable. Each embodiment may be presented fully assembled or may be presented in parts that are required to be put together prior to use. Individual variations described herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope of the present invention.

The image capture device(s) described in each embodiment may be configured to have a field of view extending away from the distal end of the member and at any alignment with the trocar member or tip. The image capture device(s) has a field of view configured to capture the whole of the area or part of the area that the glaucoma drainage device, stent, intraocular pressure reducing device, intraocular device or the drug delivery system can be placed inside the eye or orbit. The image capture device(s) has a field of view configured to capture the whole of the area or part of the area of the anterior or posterior segment inside the eye. The image capture device may comprise an ultrasound transducer, an optical imaging device, such as an image capture chip or optical imaging fiber bundle or an OCT imaging fiber(s). A fluid reservoir, protecting or insulating material may be coupled to any of the above image capture devices to aid it’s safe use.

Each of the image subsystems described in all of the above figures may be coupled with various electrical/connecting leads to a control/display interface module of the system. An image printing device may be connected to the control/display interface module of the system. A sleeve, protective layer or an insulting layer or similar may be present on the image capture device for it’s safe. Battery or mains, rechargeable or non rechargeable power sources may be used to power the units. Coupling material may be required to obtain images.

Any of the devices described for carrying out intraocular diagnostic or interventional procedures may be made available in packaged combination for use in such interventions. These packaged kits may further include instructions for use and be packaged as single use sterile trays or reusable trays after sterilisation. Methods recited herein may be carried out in any order of the recited events which is logically possible, as well as in the recited order of events. Various changes may be made to the invention detailed and equivalents may be replaced without departing from the true spirit and scope of the invention. In addition, where a range of values is provided (ie size of the needle tip, number of lumens or amount of OCT fibers), it is understood that every intervening value, between the upper and lower limit of the range and any other stated or intervening value in that stated range, is encompassed within the intervention. Reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, “a”, “an”, “said” and “the” include plural referents.

Claims

1. An apparatus and method for conducting an ophthalmic intervention or diagnosis comprising: an elongate trocar member with a sharp or blunt tip having proximal and distal ends, a longitudinal axis, and defining a first working lumen with a expandable/ extendable/retractable distal member or the lumen containing a glaucoma drainage device, stent, intraocular pressure reducing device, intraocular device or a drug delivery system. The elongate trocar member having a housing and handle for ease of use. The elongated trocar member having one or more lumens.

2. The apparatus of claim 1, further comprising an image capture device coupled to the elongate trocar member, it’s housing or it’s handle or the image capture device to be introduced via a lumen or an opening in the trocar member, it’s housing or it’s handle. The coupling may be by any permanent or temporary method. The image capture device may comprise an optical imaging device. The image capture device may comprise an optical coherence tomography imaging fibers). The image capture device may comprise an ultrasound transducer. The image capture device may comprise of a combination of an ultrasound, an optical coherence tomography imaging fiber (s) and an optical imaging device.

3. The apparatus as claimed in claim 1 or claim 2, wherein the image capture device may be connected and disconnected to the elongate trocar member, it’s housing or it’s handle by any permanent or temporary method.

4. The apparatus as claimed in claim 1, claim 2 or claim 3, wherein the image capture device is configured to have a field of view extending away from the distal end of the elongate trocar member and at least partially in alignment with the longitudinal axis of the elongate trocar member, wherein the field of view of the image capture device captures a substantial portion if not the whole of the anatomy of the eye and ocular and orbital structures.

5. The apparatus in any preceding claim, wherein an expandable, extendable, or retractable distal member(s) comprises one or more cutting elements configured to lacerate nearby tissue by any method.

6. The apparatus in any preceding claim, wherein the elongated trocar member, it’s housing or it’s handle further comprise an image capture device without a glaucoma drainage device, stent, intraocular pressure reducing device, intraocular device or a drug delivery system.

7. The apparatus in any preceding claim, wherein the apparatus may be placed inside the eye or outside the eye to aid imaging of the eye.

8. The apparatus in any preceding claim, wherein the needle or knife tip or blunt probe may be part of the distal end of the elongated trocar member or part of an expandable/extendable/retractable instrument inside the lumen of the elongated trocar member. The instrumented needle design having a similar look to a needle, hub and syringe appearance with an image capture device build into or attached to the needle trocar member, it’s housing or it’s handle. The image capture device may be coupled or attached to the needle type design by any temporary or permanent method. The needle tip or knife tip or blunt probe may be retractable, removale or fixed.

9. The apparatus in any preceding claim, wherein a pre-loaded injector with a stent, intraocular pressure reducing device, glaucoma drainage device, intraocular device or the drug delivery system to have a lumen, hole, chamber, attachment or housing to introduce or hold an image capture device such as an optical imaging device, ultrasound transducer, optical coherence tomography (OCT) fiber(s). The image capture device may be permanently or temporarily attached to any part of the pre-loaded injector or any of it’s attachments.

10. The apparatus in any preceding claim, wherein each of the image subsystems described may be coupled with various electrical/connecting leads to a control/ display interface module of the system. An image printing device may be connected to the control/display interface module of the system.

11 .The apparatus in any preceding claim, wherein each embodiment may be disposable or reusable. Any part or parts of each embodiment may be disposable or reusable.

12.The apparatus in any preceding claim, wherein each embodiment may be presented fully assembled or may be presented in parts that are required to be put together prior to use.