Ocular implant system

Abstract

An ocular implant system is described herein in which an implant (200) is deployed in the posterior space of an eye - e.g., the suprachoroidal space or the subconjunctival space or the intrascleral space - through an access in the anterior chamber (160) for reducing intraocular pressure in the eye. The shunt device (200) is implanted using an implantation device that includes a hollow shaft (330) mounted on a fixed shaft (320). The shunt device (200) is located in the distal end of the hollow shaft (330) and adjacent to the distal end of the fixed shaft (320) at a location behind the distal end of the hollow shaft. Once the distal end of the hollow shaft (330) and the shunt device (200) are at the desired depth within the posterior space, the hollow shaft is withdrawn over the fixed shaft through the access in the anterior chamber (160) towards the proximal end of the fixed shaft, leaving the shunt device in the posterior space.

Description

[0001] This application is a divisional application of the application filed on December 13, 2016, with national application number 201680076221.4 (international application number PCT / EP2016 / 080763) and entitled "Eye Implant System". Technical Field

[0002] The present invention relates to ocular implant systems, and more particularly, but not exclusively, to means for delivering ocular implants to a predetermined location in the eye. Background Technology

[0003] The mammalian eye comprises an anterior chamber located between the cornea and the iris and lens. This anterior chamber is filled with a fluid called aqueous humor. A trabecular meshwork, containing numerous tiny channels, is located in the angle between the iris and cornea. In a normal human eye, aqueous humor is produced by the ciliary body behind the iris at a constant rate—typically about 2.2 to 2.7 microliters (μl / min). In the normal outflow pathway, this aqueous humor flows between the lens and iris, and then drains through the trabecular meshwork back into the circulatory system.

[0004] The intraocular pressure (IOP) maintaining this outflow from a normal eye typically remains within the range of 10 mmHg to 20 mmHg. However, IOP can vary significantly depending on the cardiac cycle, blinking, daytime activity, and other factors. In the most common type of chronic glaucoma—where the anterior chamber angle remains open—a blockage occurs in the trabecular meshwork's fluid outflow pathway, leading to an excessive buildup of fluid in the eye and subsequently causing IOP to rise to values ​​consistently greater than approximately 18 mmHg. In some cases, IOP can reach as high as 50 mmHg or more. Over time, this increased pressure causes irreversible damage to the optic nerve and results in vision loss.

[0005] Glaucoma is a leading cause of blindness worldwide, affecting more than 80 million people. Glaucoma is associated with multiple conditions, including high blood pressure, diabetes, steroid use, and ethnicity. Currently, various treatments are available for glaucoma, including medication, laser trabeculoplasty, trabeculectomy, and intraocular drainage implants.

[0006] Medications are typically administered as eye drops to control fluid inflow—specifically, to control the formation of aqueous humor in the ciliary body—or to facilitate fluid outflow through the trabecular meshwork. Unstable dosage, side effects, and poor patient compliance are common problems.

[0007] Among the alternatives to medications used to treat glaucoma, surgically creating shunts or drainage tubes around or through the trabecular meshwork serves as a means of releasing excess fluid and thereby relieving accumulated intraocular pressure (IOP). In trabeculoplasty, a laser is used to create small openings in the trabecular meshwork of the eye, allowing aqueous humor to drain through and thus lowering intraocular pressure in the anterior chamber of the eye. This treatment is primarily used for open-angle glaucoma.

[0008] Surgical techniques include trabeculectomy. Trabeculectomy is a surgical technique in which a small opening is created in the trabecular meshwork to allow fluid to drain from the anterior chamber, accumulate beneath the conjunctiva, and be reabsorbed by the posterior portion of the eye.

[0009] Implantable devices are most commonly used when other treatments have failed. These implants include drainage devices inserted into the eye to allow aqueous humor to drain through a drainage path and out of the anterior chamber. Using conventional implants such as the Molteno implant, Baerveldt shunt, and Ahmed valve, the drainage path is formed by a tube placed between the anterior chamber and a fluid dispersion plate, which is located on the sclera and below the conjunctiva. The fluid dispersed through this plate forms a pool or “bubble” that is slowly reabsorbed into the outer layer of the eye. Recently, a new generation of drainage devices has been designed that are implanted via a minimally invasive surgical approach—limited surgical manipulation of the conjunctiva and sclera—presenting a safer surgical profile than conventional drainage implants and revolutionizing glaucoma treatment. These miniature drainage devices, known as MIGS (Minimally Invasive Glaucoma Surgery), such as the iStent, are examples. Suprachoroidal micro-bypass stents, Cypass micro-stents, and Xen gel stents are designed to reduce intraocular pressure by entering the suprachoroidal space or the subconjunctival space.

[0010] In iStent In choroidal micro-Bypass and Cypass micro-stents, there is a cavity extending longitudinally through the stent, into which a guide or shaft is inserted for positioning within the target tissue, and, when correctly positioned, the guide or shaft retracts, thereby leaving the stent in the target tissue. One such implant is described, for example, in US-B-8337393.

[0011] US-B-8852136 discloses an implantable device for inserting an intraocular shunt into the intrascleral space of the eye. The implantable device includes a hollow shaft configured to hold the intraocular shunt and configured for insertion into the eye, through which the intraocular shunt is ejected or configured before removal from the eye. The intraocular shunt is positioned such that it forms a channel from the anterior chamber of the eye to the intrascleral space, allowing aqueous humor to drain from the anterior chamber into the extrascleral vascular complex of the eye. Placement of the intraocular shunt also allows diffusion into the subconjunctival space or suprachoroidal space.

[0012] US-B-8388568 also discloses an implantable device for inserting an intraocular shunt into the eye. The placement device is configured to hold the intraocular shunt when inserted into target tissue within the eye, and once the placement device is in place within the target tissue, the intraocular shunt is disposed or ejected from the placement device. In some embodiments of the placement device, a portion of the placement device is designed to provide a resistance value to indicate that the placement device has advanced through the anterior chamber and is correctly positioned for placement of the intraocular shunt. Placement of the intraocular shunt can allow aqueous humor to flow from the anterior chamber into the subconjunctival space or the suprachoroidal space.

[0013] Although the devices described are known for implanting stents and intraocular implants, these devices often have several drawbacks, such as the need for the stent to be mounted on a guide or shaft via a cavity for implantation, or the need for the implant to be delivered from the device to the correct position within the eye, as described in US-B-8852136 and US-B-8388568 above. Furthermore, these devices are inserted into the eye, the stent or intraocular implant is disposed from the device, and the device is removed from the eye.

[0014] WO-A-2011 / 084550 describes an implantation system for implanting an object into the retinal region of the eye. The implantation system includes: a delivery unit support or housing; a delivery unit (in the form of a mandrel or fixed shaft and a mandrel guide or hollow shaft) mounted within the delivery unit support or housing; and a delivery controller or slider mounted on the outside of the delivery unit support. The delivery controller may be attached to the mandrel or fixed shaft, or to the mandrel guide or hollow shaft, wherein movement of the mandrel via the mandrel guide is considered active movement and retraction of the mandrel guide on the mandrel is considered passive movement. A spring may be used to bias the delivery unit longitudinally for either active or passive movement. In one embodiment, the object to be implanted is located at the distal end of the mandrel, and in other embodiments, a nozzle may be provided at the distal end of the mandrel guide for holding the object to be implanted.

[0015] However, in each embodiment of the implantation system described in WO-A-2011 / 084550, stability that ensures smooth and stable movement of the object when it is implanted into the eye cannot be provided within the housing because the delivery controller is attached only to the mandrel or only to the mandrel guide. Summary of the Invention

[0016] Therefore, one object of the present invention is to provide an implantation device that does not require ejection of the implant from the device.

[0017] Another object of the present invention is to provide an implantation device in which the implant does not need to be mounted on a guide during implantation into the eye.

[0018] Another object of the present invention is to provide an ocular implant system in which the implantation device delivers the implant into the eye using simple forward and backward movements.

[0019] Another object of the present invention is to provide an ocular implant system in which the implantation device includes an implant located in a portion thereof, and the implant is left in the posterior space of the eye by providing an entrance to the anterior chamber through a portion of the implant.

[0020] According to one aspect of the present invention, an implantation device is provided for implanting an implant into a posterior space of the eye, the device comprising:

[0021] case;

[0022] A fixed shaft having a proximal end and a distal end, the proximal end being mounted within and fixed relative to the housing, and the distal end extending out of the housing;

[0023] A delivery mechanism comprising a sliding element mounted on a fixed shaft and at least partially housed within a housing, the sliding element configured to move relative to the housing and relative to at least the fixed shaft between a first position and a second position; and

[0024] A hollow shaft having a distal end and a proximal end, and configured to be mounted on the distal end of a fixed shaft and configured to be connected to a sliding element at its proximal end, the hollow shaft being configured to hold an implant within a portion of the hollow shaft located at the distal end of the hollow shaft, the hollow shaft being configured to retract on the fixed shaft by movement of the sliding element from a first position to a second position to release the implant from the distal end of the hollow shaft;

[0025] The delivery mechanism is characterized by further including a sliding shaft, which is installed inside the housing and configured to be parallel to the fixed shaft, with sliding elements mounted on both the sliding shaft and the fixed shaft.

[0026] By configuring the sliding shaft parallel to the fixed shaft and mounting the sliding element on both shafts, a smooth and stable movement of the sliding element is provided as the hollow shaft retracts on the fixed shaft.

[0027] Furthermore, the implantation device of the present invention has the advantage that the delivery mechanism operates only on the hollow shaft to retract it on the fixed shaft, thereby leaving the implant in place within the posterior space of the eye. In fact, no contact with the intraocular implant itself is required during placement of the intraocular implant from the distal end of the hollow shaft.

[0028] Furthermore, there is no need to eject the implant from the implantation device or inject the implant into the space behind the eye.

[0029] In one embodiment, the proximal end of the hollow shaft is mounted to a fixing element configured for insertion into a housing and onto the fixing shaft, and for engagement with a sliding element within the housing. The fixing element may include a connecting portion configured to engage with a connecting portion of the sliding element. Additionally, the connecting portion of the fixing element may include a recess providing at least two engagement surfaces, and the sliding element connecting portion includes at least two end portions configured to be pushed away by insertion of the fixing element, the at least two end portions being configured to provide engagement surfaces engaging with the engagement surfaces of the fixing element.

[0030] In one embodiment, the fixing element includes a body portion whose surface is configured to indicate the correct orientation for inserting the fixing element into the housing.

[0031] In a preferred embodiment, the fixing element includes a one-click fixing connection element.

[0032] In one embodiment, the hollow shaft has an internal profile configured to substantially match the external profile of the fixed shaft. By matching the internal profile of the hollow shaft to the external profile of the fixed shaft, the hollow shaft can utilize the fixed shaft as a guide to ensure smooth retraction on the fixed shaft, thereby releasing the implant from the distal end of the hollow shaft and positioning the implant within the posterior space.

[0033] In one embodiment, the hollow shaft includes a generally transparent plastic material, comprising one of thermosetting and thermoplastic materials. The plastic material can be flexible or rigid and may include a biocompatible plastic material. Alternatively, the hollow shaft includes a biocompatible metallic material. The use of biocompatible materials prevents eye irritation during implantation.

[0034] Preferably, the hollow shaft has a sloping tip. More preferably, this sloping tip is configured to prevent damage, thereby reducing injury and irritation to the eye during implantation. Also preferably, the distal end of the hollow shaft is configured to be flexible to match the curvature of the eye tissue to which the implant will be placed.

[0035] In another embodiment, the hollow axis includes at least one mark indicating the insertion depth relative to the posterior space within the anterior chamber of the eye. By using one or more marks located on the hollow axis, one or more indications are provided to ensure that the implant is correctly positioned within the posterior space.

[0036] In another embodiment, the implantation device includes a light source configured to provide light for visual contrast between the implant and the posterior space of the eye. At least one light source may be provided, configured to emit light of at least one color. The advantage of this light source is that the implant becomes more visible and easily identifiable within the eye. The selected color of light allows for accurate implant positioning because it can be a color absorbed or reflected by the implant to provide a clear contrast with surrounding tissue. The color of light can be selected based on the surrounding tissue to ensure contrast.

[0037] A waveguide can be provided, connected to a light source, and configured to guide light emitted by the light source to the distal end of the hollow shaft. By using the waveguide, light can be guided more appropriately, preventing light from flooding the eye during implantation. The waveguide can be formed on at least one portion of the fixed shaft or on at least one portion of the hollow shaft. This means that no additional components are required to guide light to the distal end of the hollow shaft.

[0038] In manual operation of the implantation device, a button is mounted on the housing and configured to move relative to the housing. This button is connected to a delivery mechanism and is configured to move a sliding element between a first position and a second position when moved relative to the housing. In effect, movement of the button along the direction from the distal end to the proximal end of the fixed shaft causes the hollow shaft to retract on the fixed shaft, thereby releasing the implant from the hollow shaft.

[0039] According to another aspect of the invention, an ocular implant system is provided, the ocular implant system being configured for implanting an implant into a posterior space in the eye, the ocular system comprising: an implant configured for implantation into a posterior space in the eye; and an implantation device as described above, the implant being located in the distal end of a hollow axis.

[0040] In one embodiment, the ocular implant system can be configured for "single-use" and the ocular implant system is assembled for implanting an implant into the posterior space of the eye. This has the advantage that it eliminates the need to position the implant within the hollow axis, or, if the implant is located within the distal end of the hollow axis, it eliminates the need to mount the hollow axis onto a fixed axis each time the implant is implanted.

[0041] In another embodiment, the actuation mechanism is configured to be flexibly connected to the implantation device and configured to move a sliding element of the delivery mechanism between a first position and a second position of the sliding element. By having a separate actuation mechanism—which is not part of the implantation device—better control can be provided for retracting the hollow shaft onto the fixed shaft. In fact, since the actuation mechanism can be operated with a different hand than the hand holding the implantation device, smooth retraction can be provided.

[0042] In another embodiment, the actuation mechanism includes a pneumatic plunger device configured to connect to an operating mechanism connected to a delivery mechanism. The operating mechanism includes an inner portion and an outer portion at least partially surrounding the inner portion, the inner and outer portions being configured to move relative to each other. By having an operating mechanism including an inner and outer portion and connecting the actuation mechanism to the implantation device, one of the inner and outer portions can determine the spacing between the two devices, while relative movement of the other portion can actuate a sliding element of the implantation device. In a preferred embodiment, the operating mechanism includes an inner wire connecting a sliding element in the delivery mechanism to a separate actuation mechanism having an outer sheath disposed thereon. The inner wire is slidable within the outer sheath.

[0043] The implant may include at least one mark configured to indicate the insertion depth of the implant relative to the anterior chamber and the eye in the posterior space. This has the advantage of providing a way to determine whether the implant is correctly positioned in the posterior space. Preferably, the mark includes a selected color chosen to provide contrast within the anterior chamber.

[0044] According to another aspect of the invention, a housing for an implantation device is provided, the implantation device comprising: a fixed shaft having a proximal end and a distal end, the proximal end being mounted within the housing and fixed relative to the housing, the distal end of the fixed shaft extending out of the housing; and a delivery mechanism comprising a sliding element mounted on the fixed shaft and at least partially mounted within the housing, the sliding element being configured to move relative to the housing and relative to at least the fixed shaft between a first position and a second position, characterized in that the delivery mechanism further comprises a sliding shaft mounted within the housing and configured parallel to the fixed shaft, the sliding element being mounted on both the sliding shaft and the fixed shaft.

[0045] According to another aspect of the invention, a hollow shaft assembly for an implantation device is provided, the hollow shaft assembly comprising: a hollow shaft having a distal end and a proximal end, the hollow shaft being configured to be mounted on the distal end of a fixed shaft and configured to be connected to a sliding element at its proximal end, the hollow shaft being configured to retain an implant within a portion of the hollow shaft located at the distal end of the hollow shaft, the hollow shaft being configured to retract on the fixed shaft by movement of the sliding element from a first position to a second position to release the implant from the distal end of the hollow shaft; an implant positioned in the distal end of the hollow shaft; and a fixing connection element to which the hollow shaft is connected.

[0046] According to another aspect of the invention, an ocular implant kit is provided, comprising a housing and a hollow shaft assembly as described above. Attached Figure Description

[0047] To better understand the present invention, reference will now be made to the accompanying drawings by way of example, in which:

[0048] Figure 1 A sagittal cross-sectional view of the eye is shown;

[0049] Figure 2 An enlarged cross-sectional view of the eye is shown, revealing part of the anterior chamber and outer layer of the eye;

[0050] Figure 3 An implantation device according to the present invention is shown;

[0051] Figure 4 It shows Figure 3 The inside of the implanted device;

[0052] Figure 5 It shows Figure 3 An exploded view of the implantable device;

[0053] Figure 6 It shows the formation Figure 3 The hollow shaft of the implantation device and the implant to be implanted;

[0054] Figure 7 It shows Figure 6 An enlarged view of the implant shown;

[0055] Figure 8a and Figure 8b It shows in Figure 3 Two alternative configurations of implants used in implantable devices;

[0056] Figure 9 The implant was demonstrated using a minimally invasive ab interno method.

[0057] Figure 10 The procedure for removing the implanted device is shown.

[0058] Figure 11 The implant is shown in place in the eye;

[0059] Figure 12 It shows the connection to Figure 3 The actuation mechanism of the implanted device;

[0060] Figure 13 It shows Figure 12 The actuating mechanism, wherein a portion of the handle of the actuating mechanism is removed;

[0061] Figure 14 It shows Figure 12 and Figure 13 An enlarged view of a part of the actuation mechanism;

[0062] Figure 15 It shows Figures 12 to 14 Exploded view of the actuation mechanism;

[0063] Figure 16 A perspective view of another embodiment of the implantation device according to the present invention is shown;

[0064] Figure 17 It shows Figure 16 A three-dimensional view of the implanted device, in which part of the handle has been removed;

[0065] Figure 18 The implementation in Figure 16 and Figure 17 A perspective view of the sliding element in the illustrated embodiment;

[0066] Figure 19 A first embodiment of a one-key mating connector with a hollow shaft is shown; and

[0067] Figure 20A second embodiment of a one-touch coupling with a hollow shaft is shown. Detailed Implementation

[0068] The invention will be described with reference to specific embodiments and accompanying drawings, but the invention is not limited to these specific embodiments and drawings. The described drawings are merely illustrative and not limiting. In the drawings, for illustrative purposes, the dimensions of some elements may be enlarged and they may not be drawn to scale.

[0069] This invention relates to a system comprising a single-use, minimally invasive implantable or placement device from which an intraocular shunt or implant is placed into the suprachoroidal space—the space between the sclera and choroid of the eye—or into the subconjunctival space—the space between the conjunctiva and sclera of the eye. The intraocular shunt or implant is pre-loaded within a portion of the implantable or placement device and is released from that portion, as will be described in more detail below. In one embodiment, the implantable or placement device is single-use; however, it will be readily understood that the implantable or placement device may be reusable.

[0070] An intraocular shunt device or implant provides a mechanism for providing a drainage pathway between the anterior chamber of the eye and the posterior portion of the eye (supracromandibular space, intrascleral space, or subconjunctival space), as described below with reference to the accompanying drawings. The intraocular shunt device or implant can be made of a biocompatible material—such as the biocompatible material described in EP-B-2517619. It will be readily understood that the intraocular shunt device or implant can be made of other suitable biocompatible materials—such as silicone.

[0071] In EP-B-2517619, the described biocompatible material is porous and comprises a biocompatible polymer scaffold defining a series of interconnected pores having similar diameters. Typically, the average diameter of the pores is between about 20 μm and about 90 μm, preferably between about 25 μm and about 75 μm. For use in the implants of the present invention, a preferred range is between about 25 μm and about 36 μm.

[0072] The intraocular shunt or implant may be a generally cylindrical shape with a rectangular or elliptical cross-section and a length of 5 mm, a width of 1.1 mm, and a thickness of 0.6 mm, or it may be a generally cylindrical shape with a circular cross-section and a similar length in the case of a specific diameter. The intraocular shunt or implant is stamped from a piece or sheet of biocompatible material, wherein the thickness of the piece or sheet is equal to or greater than the length of the shunt or implant. It is readily understood that the intraocular shunt or implant may be formed, for example, in other ways, but using suitable cutting means other than stamping.

[0073] As used in this article, the term "target tissue" or "multiple target tissues" refers to the tissue in which an intraocular shunt device or implant is to be positioned, namely the suprachoroidal space, subconjunctival space, or intrascleral space.

[0074] As used herein, the term "natural anchor" refers to a component that, when delivered into or configured within the eye, does not require any other element to hold it in the correct position.

[0075] As used herein, the term "posterior" refers to the location behind the anterior chamber of the eye. This term may apply to spaces existing between layers of tissue in the eye, such as the suprachoroidal space and subconjunctival space, or it may apply to spaces created within a single layer of tissue in the eye, such as the intrascleral space.

[0076] As used herein, the terms “configured” or “deployed” refer to the delivery of an intraocular shunt device or implant from an implantation or deployment device to a target tissue located within the eye. These terms are not intended to include the injection, ejection, or advancement of an intraocular shunt device or implant from an implantation or deployment device using force to deliver the shunt device or implant to the target tissue.

[0077] As used herein, the terms “intraocular shunt device,” “shunt device,” “intraocular implant,” or “implant” refer to a component implanted into the eye. The term “implant” is more common because it refers to anything implanted, but it is also used to refer to a shunt device. The term “shunt device” refers to a component through which aqueous humor can flow from the anterior chamber of the eye into target tissue located behind the component.

[0078] Identical parts are labeled in the same way, and modified and / or alternative parts are labeled with suffixes such as "A", "B", etc., or with an apostrophe ('), double apostrophe ("), etc. Additionally, similar parts have the same last two digits and different first digits; for example, hollow shafts... Figures 3 to 6In the embodiments shown, reference numerals are 330, in Figure 16 and Figure 17 The attached figure is labeled 630, in Figure 19 The attached figure is labeled 730, and in Figure 20 The attached figure is labeled 830.

[0079] First refer to Figure 1 and Figure 2 A sagittal section through the eye 100 is shown, in which the cornea 110, iris 120, pupil 130, lens 140, and ciliary body 150 are shown. Figure 2 (As shown more clearly in the image). The anterior chamber 160 is located between the lens 140 and the cornea 110.

[0080] In a normal eye, aqueous humor is produced in the ciliary body 150 and, according to the normal outflow path, circulates between the iris 120 and the lens 140 and enters the anterior chamber 160, and then drains via a porous trabecular meshwork 170 located in the anterior chamber angle 240 between the iris 120 and the cornea 110, as indicated by arrow 180. Additionally, the sclera 190 and choroid 195 are shown.

[0081] In glaucoma, the trabecular meshwork 170 is typically blocked, resulting in a damaging increase in intraocular pressure. The intraocular shunt device or implant 200 according to the invention can be implanted between the sclera 190 and the choroid 195 via an inlet in the anterior chamber 160, i.e., implanted into the suprachoroidal space, to form a fluid pathway from the anterior chamber 160 to the sub-scleral area 210, thereby bypassing the blockage and restoring fluid flow.

[0082] The shunt device or implant can be pre-loaded and compressed within a hollow shaft that forms part of the configuration or implantation device. Because the shunt device or implant is compressed before configuration, once it is positioned within the target tissue—that is, between the sclera and choroid (suprachoroidal space), between the conjunctiva and sclera (subconjunctival space), or within the sclera (intrascleral space)—it will expand after configuration and integrate with the surrounding tissue to form a natural anchor with that surrounding tissue.

[0083] The shunt device or implant may have markings thereon that allow the operator placing the shunt device or implant to control the depth of the shunt device or implant in the target tissue by holding a portion of the shunt device or implant in the anterior chamber. Placement of the shunt device or implant in the eye is achieved using an implantation or placement device, as will be described in more detail below.

[0084] The implantable device includes a minimally invasive device for inserting an intraocular shunt device or implant into the posterior space of the eye via an inlet to the anterior chamber. In one embodiment, a hollow shaft including a pre-installed shunt device or implant is inserted through the cornea, across the anterior chamber, and into the target tissue via an internal approach. In a second embodiment, a hollow shaft including a pre-installed shunt device or implant is inserted from the target tissue into the anterior chamber via an external approach. The implantable device of the present invention can be used in both internal and external approaches.

[0085] The simplest form of the implantation device includes a manually operated handheld device configured to insert a portion of the implantation device through a corneal incision, which may be made by a sharp portion at the distal end of the hollow shaft. The placement of the shunt device or implant is performed based on the operation of an insertion and placement mechanism, which will be referred to below. Figures 9 to 11 To provide a more detailed description.

[0086] In one embodiment of the implantable device, a handle or housing with a proximal and distal end is provided in an ergonomically shaped configuration. A delivery mechanism including a linear slider is mounted in the handle or housing for movement in a direction defined proximally between the distal and proximal ends of the housing or handle. The delivery mechanism is attached to the handle by a portion thereof mounted within the handle or housing, and the delivery mechanism includes a shaft mounted within the handle or housing and fixed relative to the handle or housing. The shaft has a proximal end located within the handle or housing and a distal end extending from the handle or housing. A hollow shaft can be mounted on the fixed shaft, and the hollow shaft has the ability to engage with the linear slider and the distal end therein pre-loaded with a shunt device or implant. The hollow shaft can be made of any suitable biocompatible and sterile thermosetting or thermoplastic material, or alternatively, of a biocompatible and sterile metal.

[0087] The hollow shaft is sized to fit around a fixed shaft and is sized to be movable relative to both the handle or housing and the fixed shaft, as will be described in more detail below. The hollow shaft has an internal profile, and the fixed shaft has an external profile, the internal profile of the hollow shaft being configured to substantially match the external profile of the fixed shaft. The internal and external profiles can have any suitable cross-sectional shape, such as circular, elliptical, rectangular, square, etc.

[0088] It will be understood that the hollow shaft also has an external profile that is similar to or different from its internal profile.

[0089] In an alternative embodiment of the device, an actuation mechanism is provided that can be connected via a flexible wire to a delivery mechanism located within a handle or housing. The actuation mechanism includes a plunger that, when activated, operates to retract the hollow shaft on a fixed shaft to position, release, or retain the shunt device or implant in the target tissue.

[0090] In another embodiment, the plunger of the actuation mechanism can be controlled pneumatically or electrically to ensure smooth operation of the plunger. In yet another embodiment, the plunger of the actuation mechanism can be part of a controlled friction system including O-rings or springs for smooth motion and / or translational speed control.

[0091] The implantation device is configured to extend the distal end of the hollow shaft into the target tissue space and retract the distal end of the hollow shaft from the target tissue space, thereby positioning the shunt device or implant within the target tissue. A linear slider in the handle retracts the hollow shaft on a fixed axis to correctly position the shunt device or implant in the target tissue without requiring injection of the shunt device or implant into the target tissue.

[0092] The use of a separate actuation mechanism allows the hollow shaft to retract smoothly while minimizing the movement of the operator's hand holding the implant. This separate actuation mechanism is connected to a linear slider in the handle and can be activated by a third party.

[0093] According to the invention, the shunt device or implant is not physically positioned in the eye via a fixed axis, because the fixed axis only operates to hold the shunt device or implant in place while retracting the hollow axis.

[0094] The hollow shaft may have an internal profile with a circular cross-section or any other suitable cross-section, in which the shunt device or implant is housed, as described above. In one embodiment, the shunt device or implant may have a cross-section similar to the cross-section of the internal profile of the hollow shaft, at least at the distal end of the hollow shaft.

[0095] The distal end of the hollow shaft—where a shunt device or implant for configuration is positioned—may have the same or a different cross-section as the rest of the hollow shaft. The distal end of the hollow shaft may be flat or curved. The tip of the distal end may be sloping or have a flat or tapering surface. The tip of the distal end of the hollow shaft may be blunt or sharp; if the tip is sharp, it can be used to form an incision through the tissues of the eye to allow the shunt device or implant to be correctly positioned in the posterior space of the eye. Additionally, the hollow shaft may have markings thereon indicating the positioning of the shunt device or implant within the distal end of the hollow shaft. In one embodiment, at least the distal end of the hollow shaft may be transparent.

[0096] The handle or housing may also include an embedded light-emitting diode (LED) illumination source coupled to the hollow shaft via an optical fiber cable or a waveguide. In one embodiment, the hollow shaft may be configured such that it is transparent at least at its distal end, so that light can be directed to an intraocular shunt or implant to be delivered to target tissue. The waveguide may be formed within a portion of either the hollow shaft or the fixed shaft.

[0097] An LED lighting source may include at least one LED element that can emit light of at least one color. It is possible that the color of the light emitted by the at least one LED element can be selected to provide visual contrast capable of determining the location of a shunt device or implant in target tissue.

[0098] Now go to Figure 3 An implantation device 300 is shown, which includes a handle or housing 310 and a fixation shaft 320, the fixation shaft 320 being mounted within the handle or housing 310 such that a distal end 320a of the fixation shaft extends from the handle or housing and a proximal end 320b is positioned within the handle or housing 310 (see [reference]). Figure 4 The hollow shaft 330 is mounted within the handle or housing 310 via its proximal end (not shown) and its distal end 330a extends over the distal end 320a of the fixed shaft 320 and is mounted on the fixed shaft 320. A line 340 is shown that connects the implanted device to the actuation mechanism, as will be described in more detail below.

[0099] Figure 4An implantable device 300 is shown, wherein a first portion 315a of a handle or housing 310 is removed. As shown, the proximal end 320b of a fixing shaft 320 is connected to a second portion 315b of the handle or housing 310 via a fixing element 360. The fixing shaft 320 and a sliding shaft 380 pass through a sliding element 370 configured to slide between a first position and a second position, in which the sliding element abuts against an end face 310a of the handle or housing 310, and in the second position, the sliding element abuts against the fixing element 360.

[0100] The proximal end 330b of the hollow shaft 330 engages with the sliding element 370, and the hollow shaft 330 is configured to slide on the fixed shaft 320 when the sliding element 370 moves from the first position to the second position.

[0101] exist Figure 5 An exploded view of the implantation device 300 is shown. As shown, the handle or housing 310 includes a first portion 315a and a second portion 315b. As described above, a fixing shaft 320 is mounted within the handle or housing 310 by a fixing element 360, which is fixed to the second portion 315b of the handle or housing 310.

[0102] The sliding shaft 380 is positioned parallel to the fixed shaft 320. The sliding shaft 380 may include a generally cylindrical portion 385 on which the sliding element 370 can slide from a distal end 385a to a portion adjacent to the fixed element 360. A head portion 385c may be provided at the proximal end 385b of the sliding shaft 380, which is held within a groove 315c of the second portion 315b. Similarly, the distal end 385a of the sliding shaft 380 is located within a groove 315d of the second portion 315b. Although in Figure 5 The grooves are shown as separate slots, but it should be understood that the grooves 315c, 315d may include a single shaped groove extending within the second portion 315b to accommodate the ends 385a, 385b, 385c of the sliding shaft 380.

[0103] The wire 340 includes a flexible, hollow outer wire 345a and a rigid inner wire 345b. The outer wire 345a is connected to a groove 315e in the second portion 315b of the handle or housing 310, and the inner wire 345b is connected to the sliding element 370 through a hole 370a and is configured to actuate movement of the sliding element 370 relative to the handle or housing 310, that is, the inner wire 345b operates to move the sliding element 370 toward the proximal end 310b of the handle or housing 310. By moving the sliding element 370 toward the proximal end 310b of the handle or housing, the hollow shaft 330 retracts on the fixed shaft 320, thereby positioning the shunt device or implant 200 within the posterior portion of the eye, as will be described in more detail below.

[0104] When the first part 315a of the handle or housing 310 is mounted on its second part 315b, the fixed shaft 320 is attached to the fixed element 360, and the sliding element 370 and the sliding shaft 380 are retained in the handle or housing.

[0105] The distal end 310a of the handle or housing 310 has an elongated orifice 390 formed therein, through which the distal end 320a of the fixed shaft 320 extends. The proximal end 330b of the hollow shaft 330 is configured to be inserted through the orifice 390 and configured to engage with a portion of the sliding element 370 (not shown).

[0106] exist Figure 6 The image shows a hollow shaft 330 and a shunt device or implant 200, which is also shown in the image. Figure 7 As shown in the figure. In one embodiment, the hollow shaft 330 may have a circular cross-section with an inner circular cross-section. In another embodiment, the hollow shaft 330 may have an elongated elliptical cross-section, i.e., a cross-section having two generally parallel sides connected by arcs at each end. In another embodiment, the hollow shaft 330 may have a rectangular cross-section with an inner rectangular cross-section. In other embodiments, the cross-section may be such that the shape of the inner cross-section differs from the shape of the cross-section defined by the outer shape of the hollow shaft 330.

[0107] The shunt device or implant 200 may have a mark 205 located near its proximal end 200a, allowing the location of the shunt device or implant to be seen through the generally transparent hollow axis 330. It is readily understood that, for better visibility, other markings may be provided on the shunt device or implant 200; for example, two markings may be provided at the proximal end 200b of the shunt device or implant 200.

[0108] As described above, the shunt device or implant 200 is located in the distal end 330a of the hollow shaft 330 before implantation, and the shunt device or implant 200 comprises a suitable biocompatible material as described above. Typically, the length of the shunt device or implant can be between 4 mm and 7 mm, and the diameter can be between 0.4 mm and 2 mm. In one embodiment, the shunt device or implant 200 has a circular cross-section; however, it is readily understood that the shunt device or implant 200 can have any suitable cross-section that matches the internal cross-section of the hollow shaft 330. In another embodiment, the shunt device can have a rectangular cross-section with a length between 3 mm and 9 mm, a thickness between 0.3 mm and 1 mm, and a width between 0.5 mm and 2 mm. In a preferred embodiment, the shunt device has a length of 5 mm, a thickness of 0.6 mm, and a width of 1.1 mm. In another embodiment, the shunt device has an elliptical cross-section, wherein the dimensions of the elliptical cross-section are similar to those of a shunt device with a rectangular cross-section.

[0109] Figure 8a and Figure 8b Two alternative configurations for the illustrated shunt device or implant 200 are shown. Figure 8a In the middle, the shunt device or implant 200A opens at its distal end 200b' and the mark 205' is located at its proximal end 200a'; while Figure 8b In this shunt device or implant 200B, both its distal end 200b” and its proximal end 200a” are open, and a “waist” portion 200c is formed between its distal end 200b” and its proximal end 200a”. As previously stated, a mark 205” is provided at the proximal end 200a” of the shunt device or implant 200B.

[0110] In one embodiment, the implantable device 300 is configured as a sterile unit, namely the handle or housing 310 (as shown above). Figures 3 to 5 The described handle or housing 310 internal components), fixed shaft 320, and hollow shaft 330 including a shunt device or implant 200 at its distal end 330a are ready for use when their sterile packaging has been removed.

[0111] During assembly, the portion of the fixed shaft 320 extending from the sliding element 370 is shorter than the portion of the hollow shaft 330 extending from the sliding element 370 by at least the length of the shunt device or implant 200. This means that in the implantation configuration, the shunt device or implant 200 is located in the distal end 330a of the hollow shaft 330 and abuts against the end of the fixed shaft 320 at the distal end 320a of the fixed shaft 320.

[0112] Although not shown, the sliding element 370 can be biased to a first position by an elastic element located on the fixed shaft 320 between the sliding element 370 and the fixed element 360, and moved to a second position against the action of the elastic element, to ensure smooth movement of the hollow shaft 330 on the fixed shaft 320 during release of the intraocular shunt device or implant. It should be understood that the elastic element can be located at any other suitable position within the handle or housing to provide proper biasing of the sliding element 370. The elastic element can be a compression spring, or any other suitable elastic element capable of deforming as the sliding element 370 moves from the first position to the second position within the handle or housing.

[0113] Figure 9 The implantation of an intraocular shunt device or implant 200 using an intraocular approach is illustrated. As shown, the shunt device or implant 200 is held within a hollow shaft 330 mounted on a fixed shaft 320; for clarity, the total length of the hollow shaft 330 and the fixed shaft 320 is not shown. In this embodiment, the hollow shaft 330 has a sloping tip at its distal end 330a, which facilitates easy passage of the hollow shaft through the cornea 110. The hollow shaft 330 is then guided into the anterior chamber 160 of the eye, through the anterior chamber 160 to the anterior chamber angle 240, and into the subscleral space 210. As shown, the sloping tip at the distal end 330a of the hollow shaft 330 is also configured to provide soft penetration into the subscleral space as shown.

[0114] It is easy to understand that the distal end 330a of the hollow shaft 330 does not need to provide an incision into the cornea, and this can be done with a separate tool in which the hollow shaft is inserted into the incision.

[0115] Figure 10 and Figure 9 Similar, but Figure 10 The intraocular shunt device or implant 200 is shown in place within the subscleral space 200. The hollow shaft 330 is shown retracted relative to the fixed shaft 320. During the placement of the intraocular shunt device or implant 200 within the subscleral space after it has been correctly positioned, the sliding element 370 moves within the handle or housing 310 from its distal end 310a toward the fixed element 360. This movement causes the hollow shaft 330, connected to the sliding element 370, to retract on the fixed shaft 320, thereby placing the shunt device or implant 200 in place within the subscleral space.

[0116] In the simplest embodiment, a portion of the sliding element 370 may extend through a portion 315a of the handle or housing 310, and this portion of the sliding element 370 is configured to be manually moved by a physician from a first position to a second position to implant the shunt device or implant 200 into the eye. However, in other embodiments, the sliding element 370 is located within the handle or housing 210, and the sliding element 370 is configured to be operated using an actuation mechanism, as will be described in more detail below. It is important that the hollow shaft 330 retracts smoothly and in a controlled manner so that the shunt device or implant 200 is not moved or damaged during removal of the hollow shaft 330 of the implant 300 from the anterior chamber angle 240, and so that there is no damage to the eye itself.

[0117] Figure 11 The diagram illustrates the placement of a shunt device or implant 200 after removal of the implanted device from the eye. As shown, the majority of the shunt device or implant 200 is positioned in the subscleral space 210, with the distal end 200a of the shunt device or implant 200 situated in the anterior chamber 160. Aqueous humor flows from the anterior chamber 160 into the suprachoroidal space, thereby reducing intraocular pressure.

[0118] As shown above (refer to the reference) Figures 3 to 5 As described, the implantation device 300 also includes a wire 340, which includes a flexible, hollow outer wire 345a and a rigid inner wire 345b. Figures 12 to 14 The implantation device 300 is shown connected to the actuation mechanism 400 via line 340.

[0119] The actuation mechanism 400 includes a handle 410 in which a plunger 420 is mounted. The actuation mechanism is connected to the handle 410 via a wire 340. An outer wire 345a is connected to a slot 410a of the actuation mechanism 400, and an inner wire 345b is connected to a portion 430 of the plunger 420. Pressing down the plunger 420—that is, moving the plunger 420 toward the handle 410—removes the inner wire 345b from the handle 310 of the implantation device 300, thereby moving the sliding element 370 from its first position to its second position and retracting the hollow shaft 330 on the fixed shaft 320. To prevent premature depressurization of the plunger 420, a stop element 440 is provided. Figure 12 The stop element 440 is used to prevent the plunger from moving before it is removed.

[0120] exist Figure 15A pneumatic actuator 500 is shown, comprising a housing or handle similar to a housing or handle 410. The housing includes a first portion 515a and a second portion 515b, in which a piston (generally shown as 520) is mounted. A plunger 530 is connected to the piston 520, and when the plunger 530 is pressed down, the piston is actuated and the internal line 345b is withdrawn from the handle 310 of the implantation device 300, causing the hollow shaft 330 to retract onto the fixed shaft 320, as described above. Furthermore, a stop element 440 is shown, and this stop element 440 is referenced above. Figure 12 Operate as described.

[0121] It is readily understood that smooth and controlled operation of the actuation mechanism is desired, and this smooth and controlled operation can be ensured by pneumatically controlling the plunger of the actuation mechanism. Alternatively, the plunger of the actuation mechanism can form part of a controlled friction system, which includes an O-ring or spring for smooth motion and / or translational speed control (not shown).

[0122] Figure 16 Another embodiment of the implantation device 600 is shown, which includes a handle or housing 610 and a fixing shaft 620 mounted within the handle or housing 610. As shown, the handle or housing 610 has a distal end 610a and a proximal end 610b.

[0123] The device 600 also includes a hollow shaft assembly having a hollow shaft 630 attached to a one-touch mating connection element (OTFC) 635. The OTFC 635 is hollow, allowing the fixed shaft 620 to pass through the OTFC 635 and into the hollow shaft 630 when the OTFC 635 is mounted within the distal end 610a of the handle or housing 610.

[0124] The distal end 635a of the OTFC 635 retains the hollow shaft 630, and the proximal end 635b of the OTFC 635 is configured to be mounted within the sliding element 670 when inserted into the elongated orifice 690 formed in the distal end of the handle 610 (see reference ). Figure 19 (More detailed description).

[0125] A removable cap 695 is disposed on the distal end 635a of the OTFC 635 and on the hollow shaft 630. The cap 695 serves to protect the hollow shaft 630, and the shunt device and implant (not shown) are located within the distal end 630a of the hollow shaft 630 due to the insertion of the OTFC 635 into the handle 610. The removable cap 695 is optional, and it must be removed from the OTFC 635 after the proximal end 630b of the hollow shaft has been coupled to the sliding element 670 in the handle or housing 610 and before the distal end 630a of the hollow shaft 630 is introduced into the eye during the implantation of the shunt device or implant.

[0126] Now go to Figure 17 The illustration shows an implantation device 600, in which a first portion (not shown) of the handle 610 is removed to show the interconnection between the OTFC 635 and the sliding element 670. The proximal end 620b of the fixing shaft 620 is connected to a second portion 615b of the handle or housing 610 via a fixing element 660. The fixing shaft 620 and the sliding shaft 680 pass through a sliding element 670 configured to slide between a first position and a second position, in which the sliding element 670 abuts against an end face 610a of the handle or housing 610, and in the second position, the sliding element 670 abuts against the fixing element 660. Reference will be made below. Figure 18 The sliding element 670 will be described in more detail.

[0127] The proximal end 635b of OTFC 635 engages with the connecting element 675 of sliding element 670, thereby positioning hollow shaft 630 on fixed shaft 620. Since hollow shaft 630 is fixed to OTFC 635 and since the proximal end 635b of OTFC 630 engages with the connecting element 675 of sliding element 670, hollow shaft 630 is then fixed relative to sliding element 670 and hollow shaft 630 is configured to slide on fixed shaft 620 as sliding element 670 moves from a first position to a second position.

[0128] The slot 615e and connector 615f are shown, which receive a wire or connector (also not shown) from an external actuation mechanism (not shown).

[0129] like Figure 17As shown, the fixed shaft 620 is mounted within the handle or housing 610 by a fixing element 660, which is fixed to the second portion 615b of the handle or housing 610. A sliding shaft 680 is positioned parallel to the fixed shaft 620 in a groove 615c. The sliding shaft 680 may include a generally cylindrical portion 685 on which the sliding element 370 can slide from a distal end (not shown) of the cylindrical portion to a portion adjacent to the fixing element 360.

[0130] As shown above (refer to the reference) Figures 3 to 5 As described, by moving the sliding element 670 toward the proximal end 610b of the handle or housing 610, the hollow shaft 630 retracts on the fixed shaft 620, thereby causing the shunt device or implant 200, 200A, 200B ( Figure 7 and Figures 8a to 8b It is positioned within the posterior portion of the eye, as described above.

[0131] When the first part of the handle or housing 610 is mounted on its second part 615b, the fixed shaft 620 is attached to the fixed element 660, and the sliding element 670 and the sliding shaft 680 are held in the handle or housing.

[0132] The distal end 610a of the handle or housing 610 has an elongated orifice 690 formed therein, through which the distal end (not shown) of the fixed shaft 620 extends. The proximal end 635b of the OTFC 635 is configured to be inserted through the orifice 690 and configured to engage with the connecting element 675 of the sliding element 670. The operation of the sliding element 670 is as described above. Figures 3 to 5 as well as Figures 13 to 15 As described.

[0133] It is easy to understand that, despite Figure 16 and Figure 17 Not explicitly shown, but the OTFC 630 has a generally circular body portion 635g with a flat surface that provides proper orientation when the OTFC 635 is inserted into the handle or housing 610. Additionally, it is readily understood that the hollow shaft 630 extends through the body portion 635g and terminates approximately at the proximal end 735b of the OTFC 635 to allow the fixed shaft 620 to be inserted into the hollow shaft, as described above.

[0134] Figure 18 The sliding element 670 is shown in more detail. The sliding element 670 includes a body portion 670c having a distal end 670d and a proximal end 670e. As described above, the sliding element 670 has a longitudinally extending hole (in... Figure 18 Not shown in the image, but related to Figure 5Similar to the hole shown in the sliding element 370, the fixed shaft 630 extends through this longitudinally extending hole into and through the elongated opening 690 of the handle or housing 610 (as shown in the image). Figure 6 (As shown). Another longitudinally extending hole (in) Figure 18 It is not shown in the middle, but it is related to... Figure 5 (Similar to the hole shown for sliding element 370) allows sliding element 670 to be mounted on sliding shaft 680. A connector (not shown) for connecting to the control line may also be provided at the proximal end 670e, as referred above. Figures 3 to 5 As described.

[0135] The sliding element 670 has a portion 670f formed along its length (in) Figure 18 Only one portion is visible in the diagram. This portion 670f extends from near the proximal end 670e toward the distal end 670d and then into the respective connecting elements 675f, 675g, as shown. The connecting elements 675f, 675g include respective end portions 675h, 675i, which provide engagement surfaces 635j, 635k disposed on the OTFC 635 (see [reference needed]). Figure 16 The flat joint surfaces 675j and 675k are joined.

[0136] The end portions 675h and 675i are bent inward, such that when the OTFC 635 is inserted into the handle or housing 610 located on the fixed shaft extending through the distal end 670d of the sliding element 670, the proximal end 635b of the OTFC 635 forms a connecting portion (see below). Figure 19 and Figure 20 (Describing the connection portion in more detail), the connection portion has an end surface 635d that engages with the bevels 675l and 675m of the end portions 675h and 675i to push the end portions 675h and 675i apart until the engagement surfaces 635j and 635k of the OTFC 635 engage with the corresponding engagement surfaces 675j and 675k of the end portions. Once the corresponding engagement surfaces are engaged, the OTFC 635 is securely held within the sliding element 670 mounted within the handle or housing 610.

[0137] Although reference Figure 18 Only two end portions 675h and 675i are described, but it is readily understood that any appropriate number of end portions can be implemented to provide a secure engagement with the proximal end 635b of the OTFC 635.

[0138] Furthermore, it is easy to understand that the one-click fastener can be replaced by any other suitable fastener attached to the hollow shaft.

[0139] Now go to Figure 19 The diagram illustrates a hollow shaft (or OTFC) assembly including an OTFC 735, which is connected to a hollow shaft 730 at its distal end 735a. A removable cap (not shown) may be provided to the hollow shaft 730 prior to use. The OTFC 735 has a body portion 735c and a connecting portion 735d located at the proximal end 735b of the OTFC 735, the connecting portion 735d being configured for connection to the referenced above. Figure 18 The described sliding element 670. The connecting portion 735d includes an end surface 735e having inclined surfaces 735l and 735m, which are referenced above. Figure 18 The inclined surfaces 675l and 675m of the described sliding element 670 are engaged.

[0140] Additionally, a recess 735f is provided adjacent to the connecting portion 735d, which defines engagement surfaces 735j and 735k that engage with the corresponding engagement surfaces 675j and 675k of the sliding element 670 as described above. Once the end portions 675h and 675i cross the end surface 735d along the ramps 735l and 735m and enter the recess 735f, the engagement surfaces 735j and 735k engage with the corresponding engagement surfaces 675j and 675k of the sliding element 670 to hold the hollow shaft or OTFC assembly in place within the handle or housing 610 when the hollow shaft 730 is located on the fixed shaft 620 (as described above). Figure 16 and Figure 17 (As described).

[0141] The body portion 735c of the OTFC 735 includes a generally circular body portion 735g having a flat surface 735h formed therein. The flat surface 735h provides the user with an indication of the correct orientation for inserting the proximal end 735b into the sliding element 670 located within the handle or housing 610.

[0142] exist Figure 19In the illustrated embodiment, the hollow shaft 730 has a curved portion 730c disposed near its distal end 730a and an inclined tip 730d at the distal end 730a. In use, the inclined tip 730d is oriented such that its inclined surface faces upward. The upward orientation of the inclined tip 730d aligns with the flat surface 735h of the OTFC 735, allowing the hollow shaft or OTFC assembly to be properly inserted into the handle or housing 610. As described above, a shunt device or implant (not shown) is positioned at the distal end 730a of the hollow shaft 730, but retracted from the inclined tip 730d, such that the shunt device or implant is fully contained within the hollow shaft 730.

[0143] Despite Figure 19 Not shown, but it is readily understood that the hollow shaft 730 extends through the body portion 735g and terminates approximately at the proximal end of the OTFC 735, such that the fixed shaft 620 ( Figure 16 and Figure 17 A device can be inserted into the hollow shaft as described above. Additionally, the hollow shaft 730 is configured to hold a shunt device or implant (also not shown) at the distal end 730a of the hollow shaft.

[0144] Figure 20 Another hollow shaft or OTFC assembly is shown, comprising an OTFC 835 connected to a hollow shaft 830 at its distal end 835a. A removable cap (not shown) may be provided to the hollow shaft 830 prior to use. The OTFC 835 has a body portion 835c and a connecting portion 835d located at its proximal end 835b, the connecting portion 835d being configured for connection to as shown above. Figure 18 The described sliding element 670. The connecting portion 835d includes an end surface 835e having inclined surfaces 835l and 835m, which are referenced above. Figure 18 The inclined surfaces 675l and 675m of the described sliding element 670 are engaged.

[0145] Additionally, a recess 835f is provided adjacent to the connecting portion 835d, which defines engagement surfaces 835j and 835k that engage with the corresponding engagement surfaces 675j and 675k of the sliding element 670 as described above. Once the end portions 675h and 675i cross the end surface 835d along the ramps 835l and 835m and enter the recess 835f, the engagement surfaces 835j and 835k engage with the corresponding engagement surfaces 675j and 675k of the sliding element 670 to hold the hollow shaft or OTFC assembly in place within the handle or housing 610 (as described above) when the hollow shaft 830 is positioned on the fixed shaft 620. Figure 16 and Figure 17 (As described).

[0146] The body portion 835c of the OTFC 835 includes a generally circular body portion 835g having a flat surface formed therein. The flat surface provides the user with indication of the correct orientation for inserting the proximal end 835b into the sliding element 670 located within the handle or housing 610.

[0147] exist Figure 20 In the illustrated embodiment, the hollow shaft 830 is generally straight and has an inclined tip 830d at its distal end 830a. In use, the inclined tip 830d is oriented such that its inclined surface faces upward. The upward orientation of the inclined tip 830d aligns with the flat surface of the OTFC 835, allowing the hollow shaft or OTFC assembly to be properly inserted into the handle or housing 610. As described above, a shunt device or implant (not shown) is positioned within the distal end 830a of the hollow shaft 830 such that the shunt device or implant is completely contained within the hollow shaft 830.

[0148] Despite Figure 20 Not shown, but it is readily understood that the hollow shaft 830 extends through the body portion 835g and terminates approximately at the proximal end of the OTFC 835, such that the fixed shaft 620 ( Figure 16 and Figure 17 It can be inserted into the hollow shaft, as described above.

[0149] In another embodiment, the tip of the hollow shaft is flexible and curved to match the curvature of the sclera at the anterior chamber angle, such that the shunt device or implant is positioned in the suprachoroidal space between the scleral process and the ciliary body, wherein a portion of the shunt device or implant extends into the anterior chamber to provide a shunt path, thereby reducing IOP.

[0150] In reference Figures 16 to 20 In the described implementation, the user (typically a surgeon) has a handle 610 ( Figure 16 The handle 610 has a fixed shaft 620 extending through an elongated aperture 690 located at the distal end 610a of the handle 610. The handle 610 is preferably housed in aseptic packaging. The user also has a hollow shaft or OTFC assembly (as shown in reference...). Figure 16 , Figure 19 and Figure 20 (As described). The hollow shaft or OTFC assembly is also housed in a sterile package (with or without a removable cap) containing saline solution to prevent the shunt or implant from drying out during storage. Once both sterile packages are open, the hollow shaft or OTFC assembly is mounted in the handle or housing 610 by properly aligning the flat surface of the OTFC body with the handle or housing 610 before inserting the hollow shaft or OTFC assembly into the orifice 690 until the proximal end of the OTFC engages with the sliding element 670 within the handle or housing 610. The handle or housing 610 is also connected to the actuator, and the system is then ready for use. It is readily understood that with the hollow shaft or OTFC assembly already mounted to the handle or housing, the system can be supplied as a single item, i.e., in a single package. In this case, the single package will be sterile and may or may not include a removable cap as described above.

[0151] After use, the handle, along with the hollow shaft or OTFC assembly (which currently does not have a shunt or implant), is disconnected from the actuator and discarded, as these components of the system are single-use. The actuator can be reused after sterilization or also discarded. However, it is easy to understand that the handle may also be reusable after proper sterilization once the hollow shaft or OTFC assembly has been disconnected.

[0152] As an alternative or additional option, other types of coding can be set on the OTFC to ensure that the hollow shaft or OTFC component is correctly inserted into the handle or housing 610 before use.

[0153] In each of the embodiments described above, the hollow shaft includes a damage-preventing tip that minimizes trauma to tissues into which the hollow shaft is inserted and through.

[0154] As described above, the sliding element is operated by an actuation mechanism connected by a wire to the handle or housing. However, it is readily understood that other methods of operating the sliding element are also possible. For example, a wireless connection can be provided between the actuator and the handle or housing, through which appropriate control signals can be transmitted to a servo mechanism that retracts the sliding element and the hollow shaft, thereby positioning the shunt device or implant between the anterior chamber and the suprachoroidal space if the intended implantation site is the suprachoroidal space.

[0155] Although the invention has been described with respect to a device or system for implanting a shunt device or implant into the suprachoroidal space, other implantation sites are also possible, such as the subconjunctival space and the intrascleral space. Ideally, the hollow shaft is configured to be flexible to match the curvature of the ocular tissue in which the implant is intended to be placed.

[0156] It is readily understood that the present invention is not limited to the embodiments described above, and that alternative embodiments are also possible.

Claims

1. A hollow shaft assembly for an implantable device, the implantable device including a housing, the hollow shaft assembly comprising: A hollow shaft having a distal end and a proximal end, and configured to be mounted on the distal end of a fixed shaft fixed relative to the housing, and configured to be connected to a sliding element at its proximal end, the hollow shaft being configured to hold an implant within the portion of the hollow shaft located at the distal end of the hollow shaft, the hollow shaft being configured to retract on the fixed shaft by movement of the sliding element from a first position to a second position, thereby releasing the implant from the distal end of the hollow shaft; The implant positioned in the distal end of the hollow shaft; as well as A fixing element, wherein the hollow shaft is connected to the fixing element. The fixing element is configured to be inserted into the housing and onto the fixing shaft, and to engage with the sliding element within the housing. The implant is an intraocular implant that provides a drainage pathway between the anterior chamber of the eye and the posterior portion of the eye. The intraocular implant includes a biocompatible polymer scaffold that defines a series of interconnected holes with similar diameters. The implant has a cylindrical shape with an elliptical, rectangular, or circular cross-section.

2. The hollow shaft assembly according to claim 1, wherein, The average diameter of the pore is in the range of 25 μm to 36 μm.

3. The hollow shaft assembly according to claim 1 or 2, wherein, The implant has a length between 3 mm and 9 mm, a thickness between 0.3 mm and 1 mm, and a width between 0.5 mm and 2 mm.

4. The hollow shaft assembly according to claim 1 or 2, wherein, The implant is 5 mm long, 1.1 mm wide, and 0.6 mm thick.

5. The hollow shaft assembly according to claim 1 or 2, wherein the implant is configured to be implanted into the suprachoroidal space of the eye or into the subconjunctival space of the eye.

6. The hollow shaft assembly according to claim 1 or 2, wherein the intraocular implant is configured to provide a drainage pathway between the anterior chamber of the eye and the posterior portion of the eye.

7. The hollow shaft assembly according to claim 1 or 2, wherein one or more markings are provided on the implant and near the proximal end.

8. The hollow shaft assembly according to claim 1, wherein, The fixing element includes a connecting portion configured to engage with a sliding element connecting portion.

9. The hollow shaft assembly according to claim 8, wherein, The connecting portion of the fixing element includes a recess providing at least two engagement surfaces, and the connecting portion of the sliding element includes at least two end portions configured to be pushed apart by insertion of the fixing element, the at least two end portions being configured to provide engagement surfaces that engage with the engagement surfaces of the fixing element.

10. The hollow shaft assembly according to claim 1 or 8, wherein, The hollow shaft includes an inclined tip.

11. The hollow shaft assembly according to claim 1 or 8, wherein, The distal end of the hollow shaft is configured to be flexible to match the curvature of the eye tissue into which the implant will be placed.

12. An ocular implant system configured for implanting an implant into a posterior space within the eye, the ocular implant system comprising: An implant, specifically an intraocular implant, for providing a drainage pathway between the anterior chamber of the eye and the posterior portion of the eye, the intraocular implant comprising a biocompatible polymer scaffold defining a series of interconnected apertures of similar diameter, wherein the implant has a cylindrical shape with an elliptical, rectangular, or circular cross-section; and An implantation device for implanting an implant into a posterior space within the eye, wherein the implantation device comprises: case; A fixed shaft having a proximal end and a distal end, the proximal end being mounted within and fixed relative to the housing, and the distal end extending out of the housing; A delivery mechanism comprising a sliding element mounted on the fixed shaft and at least partially housed within the housing, the sliding element configured to move relative to the housing and relative to at least the fixed shaft between the first and second positions; and A hollow shaft having a distal end and a proximal end, and the hollow shaft being configured to be mounted on the distal end of a fixed shaft and configured to be connected to a sliding element at the proximal end of the hollow shaft, the hollow shaft being configured to hold an implant within a portion of the hollow shaft located at the distal end of the hollow shaft, the hollow shaft being configured to retract on the fixed shaft by movement of the sliding element from a first position to a second position, thereby releasing the implant from the distal end of the hollow shaft; The delivery mechanism further includes a sliding shaft, which is installed inside the housing and configured to be parallel to the fixed shaft. The sliding element is mounted on both the sliding shaft and the fixed shaft.

13. An ocular implant kit, comprising: A housing for an implantable device, the implantable device comprising: A fixed shaft having a proximal end and a distal end, the proximal end being mounted within and fixed relative to the housing, and the distal end extending from the housing; and A delivery mechanism including a sliding element mounted on the fixed shaft and at least partially housed within the housing, the sliding element being configured to move relative to the housing and relative to at least the fixed shaft between a first position and a second position; The delivery mechanism is characterized in that it further includes a sliding shaft, which is mounted within the housing and configured to be parallel to the fixed shaft; the sliding element is mounted on both the sliding shaft and the fixed shaft. The hollow shaft assembly according to any one of claims 1 to 11.

14. The ocular implant kit according to claim 13, wherein, The hollow shaft has an internal profile configured to match the external profile of the fixed shaft.

Images