HK1232763B - Intraocular shunt deployment devices - Google Patents

Description

Intraocular shunt deployment device

This application is a divisional application of chinese patent application 201180064968.5(PCT/US2011/060817) entitled "intraocular shunt deployment device" filed on 15/11/2011.

RELATED APPLICATIONS

This application claims benefit and priority from U.S. non-provisional patent application serial No. 12/946,645, filed on 11, 15, 2010, the contents of which are incorporated herein by reference in their entirety.

Technical Field

The present invention relates generally to devices for deploying an intraocular shunt within an eye.

Background

Glaucoma is an eye disease affecting millions of people. Glaucoma is associated with increased intraocular pressure, either from the inability of the drainage system of the eye to adequately remove aqueous humor from the anterior chamber of the eye, or from excessive production of aqueous humor by the ciliary body of the eye. Aqueous humor accumulation and the resulting intraocular pressure can cause irreversible damage to the optic nerve and retina, which can lead to irreversible retinal damage and blindness.

Glaucoma can be treated surgically, which involves placing a shunt in the eye to cause a fluid flow pathway between the anterior chamber and various structures of the eye that participate in aqueous humor drainage (e.g., schlemm's canal, sclera, or subconjunctival space). This fluid flow path allows aqueous humor to leave the anterior chamber. In general, the surgical procedure for implanting a shunt includes inserting a deployment device that holds an intraocular shunt into the eye and deploying the shunt within the eye. The deployed device holding the shunt enters the eye through the cornea (ab interno prophach) and is advanced through the anterior chamber. The deployment device is advanced through the sclera until the distal portion of the device is adjacent to the drainage structure of the eye. The shunt is then deployed from the deployment device, creating a conduit between the anterior chamber and various structures of the eye involved in aqueous humor drainage (e.g., schlemm's canal, sclera, or subconjunctival space). See, for example, Prywes (U.S. patent No. 6,007,511).

A problem associated with such surgical procedures is ensuring that the placement of the shunt does not change during deployment of the shunt from the deployment device. Deployment devices for placing shunts in the eye generally rely on multiple moving components in order to deploy the shunt. Movement of the components of the deployment device shifts the position of the deployment device within the eye during the deployment process, and thus shifts the position of the shunt as it is deployed. Such movement results in improper placement of the shunt within the eye.

Disclosure of Invention

The present invention relates generally to deployment devices designed to minimize movement of the device during deployment of an intraocular shunt from the device, thereby ensuring proper placement of the shunt within the eye.

In certain aspects, the deployment device of the present disclosure comprises a housing, a deployment mechanism at least partially disposed within the housing, and a hollow shaft coupled to the deployment mechanism, wherein the shaft is configured to hold an intraocular shunt. With such a device, rotation of the deployment mechanism causes deployment of the shunt. This rotational movement is translated into axial movement for deploying the shunt from the device. By utilizing the rotational motion of the deployment mechanism, axial movement of the deployment device is minimized, ensuring proper placement of the shunt within the eye.

Other aspects of the invention provide devices for deploying an intraocular shunt, comprising a housing; a deployment mechanism disposed at least partially within the housing, wherein the deployment mechanism comprises a two-stage system; and a hollow shaft coupled to the deployment mechanism, wherein the shaft is configured to hold the intraocular shunt.

Another aspect of the invention includes a device for deploying an intraocular shunt comprising a housing, a deployment mechanism at least partially disposed within the housing, and a hollow shaft coupled to the deployment mechanism within the housing, wherein the shaft is configured to hold the intraocular shunt, wherein the device comprises an insertion configuration and a deployed configuration, and the deployed configuration comprises a proximal portion of the shaft at least partially retracted within the housing. In some embodiments, the insertion configuration includes a distal portion of the shaft disposed within the housing and a proximal portion of the shaft extending out of the housing.

In some embodiments, the shaft is configured to be at least partially retracted within the housing. However, it should be understood that the shaft may be fully retracted within the housing. In some embodiments, the device further comprises an intraocular shunt. The flow diverter may be disposed entirely within the hollow shaft of the device. Optionally, the flow diverter is partially disposed within a hollow shaft of the device.

The deployment mechanism may comprise a two-stage system. In such an embodiment, the first stage is a pusher assembly and the second stage is a retraction assembly. In this embodiment, rotation of the deployment mechanism sequentially engages the pusher assembly and the subsequent retraction assembly. The pusher assembly pushes the shunt to partially deploy the shunt from within the shaft, and the retraction assembly retracts the shaft from around the shunt to deploy the shunt. In certain embodiments, the deployment mechanism may additionally include at least one element that limits axial movement of the shaft.

The hollow shaft of the deployment device may include a beveled distal end. An exemplary hollow shaft is a needle. The apparatus of the present invention may be fully automatic, partially automatic or fully manual. The device of the present invention can be connected to a larger robotic system or can be used as a stand-alone hand-held deployment device. In a particular embodiment, the device is a handheld device.

The device of the present invention may include an indicator that provides feedback to the operator regarding the status of the deployment mechanism. The indicator may be any type of indicator known in the art, such as a visual indicator, an audible indicator, or a tactile indicator. In certain embodiments, the indicator is a visual indicator.

Aspects of the invention also include methods for deploying an intraocular shunt within an eye. These methods include deploying an intraocular shunt from a device described herein within an eye using the device. Generally, deploying a shunt creates a flow path from the anterior chamber of the eye to a region of lower pressure. Exemplary regions of lower pressure include the intra-tenon's space, the subconjunctival space, the episcleral vein, the suprachoroidal space, and schlemm's canal. In certain embodiments, the lower pressure region is the subarachnoid space.

Any of a variety of methods known in the art may be used to insert the device of the present invention into the eye. In certain embodiments, the devices of the present invention may be inserted into the eye using an external approach (trans-conjunctival access) or an internal approach (trans-corneal access).

Brief Description of Drawings

Figure 1 is a schematic diagram illustrating an embodiment of a shunt deployment device according to the present invention.

Fig. 2 shows an exploded view of the device shown in fig. 1.

Fig. 3A to 3D are schematic views showing different enlarged views of the deployment mechanism of the deployment device.

Fig. 4A-4C are schematic diagrams illustrating the interaction of a deployment mechanism with a portion of a housing of a deployment device.

FIG. 5 shows a cross-sectional view of the deployment mechanism of the deployment device.

Fig. 6A and 6B show a schematic view of the deployment mechanism in a pre-deployment configuration. FIG. 6C shows an enlarged view of the distal portion of the deployment device of FIG. 6A. The figure shows the intraocular shunt stowed within the hollow shaft of the deployment device.

Figures 7A and 7B show a schematic view of the deployment mechanism at the end of the first stage of deploying the shunt from the deployment device. FIG. 7C shows an enlarged view of the distal portion of the deployment device of FIG. 7A. The figure shows an intraocular shunt partially deployed from the hollow shaft of a deployment device.

FIG. 8A shows a schematic view of the deployment device after deployment of the shunt from the deployment device. FIG. 8B shows a schematic view of the deployment mechanism at the end of the second stage of deploying the shunt from the deployment device. FIG. 8C shows an enlarged view of the distal portion of the deployment device after the shaft has been retracted, with the pusher abutting the shunt. Figure 8D shows an enlarged view of the distal portion of the deployment device after deployment of the shunt.

Figures 9A and 9B show an intraocular shunt deployed within an eye. The proximal portion of the shunt is in the anterior chamber and the distal portion of the shunt is in the intra-fascial space. The intermediate portion of the shunt is in the sclera.

Fig. 10 depicts a schematic of an exemplary intraocular shunt.

Detailed Description

Referring now to fig. 1, an embodiment of a shunt deployment device 100 according to the present invention is shown. While fig. 1 shows a hand-held, manually-operated shunt deployment device, it should be understood that the device of the present invention may be coupled to a robotic system and may be fully or partially automated. As shown in FIG. 1, the stent 100 comprises a generally cylindrical body or sheath 101, however, the body shape of the sheath 101 may be other than cylindrical. The housing 101 may have an ergonomic shape, allowing for comfortable gripping by an operator. Housing 101 is shown with an optional slot 102 to allow for easier grasping by the surgeon.

The housing 101 is shown having a larger proximal portion that tapers to a distal portion. The distal portion comprises a hollow sleeve 105. The hollow sleeve 105 is configured for insertion into the eye and extends into the anterior chamber of the eye. The hollow sleeve is visible within the anterior chamber of the eye. The sleeve 105 provides the operator with a visual preview of the placement of the proximal portion of the shunt within the anterior chamber of the eye. Additionally, the sleeve 105 provides a visual reference point that can be used by the operator to keep the device 100 stable during the shunt deployment process, thereby ensuring optimal longitudinal placement of the shunt within the eye.

The sleeve may include a rim at the distal end that provides resistance feedback to the operator when inserting the deployment device 100 into a human eye. As device 100 is advanced through the anterior chamber of the eye, hollow sleeve 105 will eventually contact the sclera, providing the operator with resistive feedback that device 100 does not require further advancement. The edges of the sleeve 105 prevent the shaft 104 from being accidentally pushed too far through the sclera. A temporary guard (guard)108 is configured to fit around the sleeve 105 and extend beyond the end of the sleeve 105. Guards are used during transport of the device and protect the operator from injury from the distal end of hollow shaft 104 extending beyond the end of sleeve 105. The guard is removed prior to use of the device.

The housing 101 is open at its proximal end such that a portion of the deployment mechanism 103 may extend from the proximal end of the housing 101. The distal end of housing 101 is also open such that at least a portion of hollow shaft 104 may extend past the distal end of housing 101 and out of the distal end of housing 101. Housing 101 further includes a slot 106 through which an operator, such as a surgeon, using device 100 can view an indicator 107 on deployment mechanism 103.

The housing 101 may be made of any material suitable for use in a medical device. For example, the housing 101 may be made of lightweight aluminum or a biocompatible plastic material. Examples of such suitable plastic materials include polycarbonate and other polymeric resins such as DELRIN and ULTEM. In certain embodiments, the enclosure 101 may be made of a material that can be autoclaved, and thus allows the enclosure 101 to be reused. Alternatively, the device 100 may be sold as a single use device (i.e., the device is disposable), and thus the material of the housing need not be an autoclavable material.

The housing 101 may be made of multiple components that are connected together to form the housing. Fig. 2 shows an exploded view of the stent 100. In this figure, the housing 101 is shown with three components 101a, 101b, and 101 c. The components are designed to be screwed together to form the housing 101. Fig. 2 also shows deployment mechanism 103. The housing 101 is designed such that the deployment mechanism 103 is mounted within the assembled housing 101. The housing 101 is designed such that the components of the deployment mechanism 103 are movable within the housing 101.

Fig. 3A to 3D show different enlarged views of the deployment mechanism 103. Deployment mechanism 103 may be made of any material suitable for use in a medical device. For example, deployment mechanism 103 may be made of lightweight aluminum or a biocompatible plastic material. Examples of such suitable plastic materials include polycarbonate and other polymeric resins such as DELRIN and ULTEM. In certain embodiments, the deployment mechanism 103 may be made of a material that can be autoclaved, and thus allows the deployment mechanism 103 to be reused. Alternatively, the device 100 may be sold as a single use device (i.e., the device is disposable), and thus the material of the deployment mechanism need not be autoclavable.

Deployment mechanism 103 includes a distal portion 109 and a proximal portion 110. Deployment mechanism 103 is configured such that distal portion 109 is movable within proximal portion 110. More specifically, distal portion 109 can be partially retracted within proximal portion 110.

In this embodiment, distal portion 109 is shown as being tapered into connection with hollow shaft 104. This embodiment is illustrated such that the connection between hollow shaft 104 and distal portion 109 of deployment mechanism 103 occurs within housing 101. In other embodiments, the connection between the hollow shaft 104 and the distal portion 109 of the deployment mechanism 103 may occur outside the housing 101. Hollow shaft 104 may be detachable from distal portion 109 of deployment mechanism 103. Alternatively, hollow shaft 104 may be permanently coupled to distal portion 109 of deployment mechanism 103.

Generally, the hollow shaft 104 is configured to hold an intraocular shunt 115. An exemplary intraocular shunt 115 is shown in fig. 10. Other exemplary intraocular shunts are shown in Yu et al (U.S. patent application No. 2008/0108933). In general, in one embodiment, an intraocular shunt is cylindrically shaped and has an outer cylindrical wall and a hollow interior. The shunt may have an inner diameter of about 50 μm to about 250 μm, an outer diameter of about 190 μm to about 300 μm, and a length of about 0.5mm to about 20 mm. Thus, the hollow shaft 104 is configured to retain at least such a shape and such a size of flow splitter. However, the hollow shaft 104 may be configured to hold shunts of different shapes and sizes than those described above, and the present invention includes a shaft 104 that may be configured to hold intraocular shunts of any shape or size. In a specific embodiment, the shaft has an inner diameter of about 200 μm to about 400 μm.

The shaft 104 may be any length. The usable length of the shaft may be any value from about 5mm to about 40mm, and in some embodiments 15 mm. In certain embodiments, the shaft is straight. In other embodiments, the shaft has a shape other than straight, such as a shaft having a curve along its length or a shaft having an arcuate portion. An exemplary shape of the shaft is shown, for example, in Yu et al (U.S. patent application No. 2008/0108933).

In a particular embodiment, the shaft includes a bend at a distal portion of the shaft. In other embodiments, the distal end of the shaft 104 is beveled or sharpened to a point to assist in piercing the sclera and advancing the distal end of the shaft 104 through the sclera. In a particular embodiment, the distal end of the shaft 104 has a double bevel. The double bevel provides an angle at the distal end of the shaft 104 so that when the shaft enters the intra-tenon space, the distal end of the shaft 104 will be parallel to the tenon's capsule and will therefore not pierce the tenon's capsule and enter the subconjunctival space. This ensures proper deployment of the shunt such that the distal end of the shunt 115 is deployed within the intra-fascial space, rather than the distal end of the shunt 115 being deployed within the subconjunctival space. Changing the angle of the bevel allows the shunt 115 to be placed in other areas of lower pressure than the anterior chamber, such as the subconjunctival space. It should be understood that implantation of the intra-tenon space is but one embodiment of placing the shunt 115 in the eye, and that the device of the present invention is not limited to placing the shunt in the intra-tenon space, and may be used to place the shunt in many other areas of the eye, such as the schlemm's canal, the subconjunctival space, the episcleral vein, or the perichoroidal space.

The shaft 104 may retain the flow splitter at least partially within the hollow interior of the shaft 104. In other embodiments, the flow diverter is held entirely within the hollow interior of the shaft 104. Alternatively, a hollow shaft may retain the flow diverter on the outer surface of the shaft 104. In particular embodiments, the flow diverter is retained within the hollow interior of the shaft 104. In certain embodiments, the hollow shaft is a needle having a hollow interior. Needles configured to hold intraocular shunts are commercially available from terrumo Medical Corp.

The proximal portion of the deployment mechanism includes an optional slot 116 to allow for easier grasping by an operator to more easily rotate the deployment mechanism, which will be discussed in more detail below. The proximal portion 110 of the deployment mechanism also includes at least one indicator that provides feedback to the operator regarding the status of the deployment mechanism. The indicator may be any type of indicator known in the art, such as a visual indicator, an audible indicator, or a tactile indicator. FIG. 3A shows a deployment mechanism having two indicators, a readiness indicator 111 and a deployment indicator 119. The readiness indicator 111 provides feedback to the operator that the deployment mechanism is in a configuration to deploy the intraocular shunt from the deployment device 100. The indicator 111 is shown in this embodiment as a green ellipse-with a triangle within the ellipse. The deployment indicator 119 provides feedback to the operator that the deployment mechanism has been fully engaged and that the shunt has been deployed from the deployment device 100. The deployment indicator 119 is shown in this embodiment as a yellow oval with a black square inside the oval. The indicators are located on the deployment mechanism such that when assembled, the indicators 111 and 119 are visible through the slot 106 in the housing 101.

The proximal end portion 110 includes a fixed portion 110b and a rotating portion 110 a. The proximal portion 110 includes a channel 112 that runs through a portion of the length of the (run) stationary portion 110b and the entire length of the rotating portion 110 a. The channel 112 is configured to interact with a protrusion 117 on an interior portion of the housing assembly 101a (fig. 4A and 4B). During assembly, the tabs 117 on the housing assembly 101a align with the channels 112 on the stationary portion 110b and the rotating portion 110a of the deployment mechanism 103. Proximal portion 110 of deployment mechanism 103 slides within housing assembly 101a until protrusion 117 is located within fixed portion 110b (fig. 4C). The assembled protrusion 117 interacts with the fixed portion 110b of the deployment mechanism 103 and prevents the fixed portion 110b from rotating. In this configuration, the rotating portion 110a is free to rotate within the housing assembly 101 a.

Referring back to fig. 3A-3D, rotating portion 110a of proximal portion 110 of deployment mechanism 103 also includes channels 113A, 113b, and 113 c. Channel 113a includes a first portion 113a1 that is straight and extends perpendicular to the length of rotating portion 110a, and a second portion 113a2 that extends diagonally down the length of rotating portion 110a toward the proximal end of deployment mechanism 103. The channel 113b includes a first portion 113b1 that extends diagonally down the length of the rotating portion 110a toward the distal end of the deployment mechanism 103, and a second portion that is straight and extends perpendicular to the length of the rotating portion 110 a. The point at which the first portion 113a1 transitions along the channel 113a to the second portion 113a2 is the same as the point at which the first portion 113b1 transitions along the channel 113b to the second portion 113b 2. The channel 113c is straight and extends perpendicular to the length of the rotating portion 110 a. Within each of the channels 113a, 113b and 113c, there is located an element 114a, 114b and 114c, respectively. The elements 114a, 114b and 114c are movable within the channels 113a, 113b and 113 c. Elements 114a, 114b and 114c also act as stops that limit movement of rotating portion 110a, which therefore limits axial movement of shaft 104.

Fig. 5 shows a cross-sectional view of deployment mechanism 103. Element 114a is attached to distal portion 109 of deployment mechanism 103. Movement of element 114a causes distal portion 109 of deployment mechanism 103 to retract into proximal portion 110 of deployment mechanism 103. Element 114b is connected to a pusher assembly 118. The pusher assembly 118 extends through the distal portion 109 of the deployment mechanism 103 and into a portion of the hollow shaft 104. The pusher assembly participates in deploying the shunt from the hollow shaft 104. An exemplary pusher assembly is a plunger. Movement of the element 114b engages the pusher 118 and causes the pusher 118 to advance within the hollow shaft 104.

Reference is now made to fig. 6-8D, which are accompanied by the following discussion regarding deployment of the shunt 115 from the deployment device 100. Figure 6A shows the deployment device 100 in a pre-deployment configuration. In this configuration, the flow diverter 115 is loaded within the hollow shaft 104 (fig. 6C). As shown in fig. 6C, the flow diverter 115 is only partially within the shaft 104 such that a portion of the flow diverter is exposed. However, the flow splitter 115 does not extend beyond the distal end of the shaft 104. In other embodiments, the flow splitter 115 is disposed entirely within the hollow shaft 104. The flow diverter 115 is loaded into the hollow shaft 104 such that the flow diverter abuts the pusher assembly 118 within the hollow shaft 104. The distal end of the shaft 104 is beveled to assist in piercing the tissue of the eye.

Additionally, in the pre-deployment configuration, a portion of the shaft 104 extends beyond the sleeve 105 (fig. 6C). The deployment mechanism is configured such that element 114a abuts the distal end of first portion 113a1 of channel 113a and element 114B abuts the proximal end of first portion 113B1 of channel 113B (fig. 6B). In this configuration, the readiness indicator 111 is visible through the slot 106 of the housing 101, which provides feedback to the operator that the deployment mechanism is in a configuration to deploy the intraocular shunt from the deployment device 100 (fig. 6A). In this configuration, the device 100 is ready for insertion into the eye (either the insertion configuration or the pre-deployment configuration). Methods for inserting and implanting the shunt are discussed in further detail below.

The shunt 115 may be deployed from the device 100 once the device has been inserted into the eye and advanced to a position where the shunt will be deployed. Deployment mechanism 103 is a two-stage system. The first stage is to engage the pusher assembly 118, and the second stage is to retract the distal portion 109 into the proximal portion 110 of the deployment mechanism 103. Rotation of the rotating portion 110a of the proximal portion 110 of the deployment mechanism 103 sequentially engages the pusher assembly with the subsequent retraction assembly.

In a first stage of shunt deployment, the pusher assembly is engaged and the pusher partially deploys the shunt from the deployment device. During the first stage, rotating portion 110a of proximal portion 110 of deployment mechanism 103 is rotated, causing elements 114a and 114b to move along first portions 113a1 and 113b1 in channels 113a and 113 b. Since the first portion 113a1 of the channel 113a is straight and extends perpendicular to the length of the rotating portion 110a, rotation of the rotating portion 110a does not cause axial movement of the element 114 a. Without axial movement of element 114a, distal portion 109 is not retracted into proximal portion 110 of deployment mechanism 103. Since the first portion 113b1 of the channel 113b extends diagonally upward along the length of the rotating portion 110a toward the distal end of the deployment mechanism 103, rotation of the rotating portion 110a causes axial movement of the element 114b toward the distal end of the device. Axial movement of element 114b toward the distal end of the device causes pusher assembly 118 to advance within hollow shaft 104. This movement of the pusher assembly 118 causes the diverter 115 to partially deploy from the shaft 104.

Figures 7A-7C show a schematic view of the deployment mechanism at the end of the first stage of deployment of the shunt from the deployment device. As shown in fig. 7A, elements 114a and 114 have completed traversing along first portions 113a1 and 113b1 of channels 113a and 113 b. Additionally, the pusher assembly 118 has been advanced within the hollow shaft 104 (fig. 7B), and the diverter 115 has been partially deployed from the hollow shaft 104 (fig. 7C). As shown in these figures, a portion of the flow diverter 115 extends beyond the end of the shaft 104.

In a second stage of shunt deployment, the retraction assembly is engaged and the distal portion of the deployment mechanism is retracted into the proximal portion of the deployment mechanism, thereby completing deployment of the shunt from the deployment device. During the second stage, rotating portion 110a of proximal portion 110 of deployment mechanism 103 is further rotated, causing elements 114a and 114b to move along second portions 113a2 and 113b2 in channels 113a and 113 b. Since the second portion 113a2 of the channel 113b is straight and extends perpendicular to the length of the rotating portion 110a, rotation of the rotating portion 110a does not cause axial movement of the element 114 b. Without axial movement of the element 114b, the pusher 118 is not advanced further. Since the second portion 113a2 of the channel 113a extends diagonally down the length of the rotating portion 110a towards the proximal end of the deployment mechanism 103, rotation of the rotating portion 110a causes axial movement of the element 114a towards the proximal end of the device. Axial movement of element 114a toward the proximal end of the device causes distal portion 109 to retract into proximal portion 110 of deployment mechanism 103. Contraction of distal portion 109 causes contraction of hollow shaft 104. Because the diverter 115 abuts the pusher assembly 118, the diverter remains stationary as the hollow shaft 104 is retracted from around the diverter 115 (fig. 8C). The shaft 104 is almost completely retracted into the sleeve 105. During both stages of the deployment process, the sleeve 105 remains stationary and in a fixed position.

Fig. 8A shows a schematic view of the device 100 after the shunt 115 is deployed from the device 100. FIG. 8B shows a schematic view of the deployment mechanism at the end of the second stage of deployment of the shunt from the deployment device. As shown in fig. 8B, the elements 114a and 114B have completed traversing along the second portions 113a2 and 113B2 of the channels 113a and 113B. Additionally, distal portion 109 has been retracted into proximal portion 110, thus causing hollow shaft 104 to retract into sleeve 105. Figure 8D shows an enlarged view of the distal portion of the deployment device after deployment of the shunt. The figure shows the hollow shaft 104 not fully retracted within the sleeve 105 of the deployment device 100. However, in some embodiments, the shaft 104 may be fully retracted within the sleeve 105.

Referring to FIG. 8A, in the post-deployment configuration, the deployed indicator 119 is visible through the slot 106 of the housing 101, providing feedback to the operator that the deployment mechanism has been fully engaged and that the shunt 115 has been deployed from the deployment device 100.

Any of a variety of methods known in the art may be used to insert the device of the present invention into the eye. In certain embodiments, the devices of the present invention may be inserted into the eye using an external approach (transcorneal access) or an internal approach (transcorneal access).

In certain embodiments, the devices of the present invention are inserted into the eye using an internal approach. The endoluminal approach for implanting intraocular shunts is shown, for example, in Yu et al (U.S. patent No. 6,544,249 and U.S. patent application No. 2008/0108933) and Prywes (U.S. patent No. 6,007,511), the contents of which are incorporated herein by reference in their entirety.

The device of the present invention may be inserted into the eye in order to deploy a shunt that creates a fluid drainage channel from the anterior chamber of the eye to various drainage structures of the eye. Exemplary drainage structures include schlemm's canal, subconjunctival space, episcleral veins, suprachoroidal space, or intrafascial space. In certain embodiments, the fluid is drained into the subarachnoid space.

In a specific embodiment, the device of the present invention is inserted into the eye to deploy a shunt, which creates a fluid drainage channel from the anterior chamber to the intra-fascial space. Within the eye, there is a membrane called the conjunctiva, and the area under the conjunctiva is called the subconjunctival space. Within the subconjunctival space is a membrane known as the fascial sac. There are fascial adhesions (Tenon's adhesions) below the fascia capsule that connect the fascia capsule to the sclera. The space between the fascial sac and the sclera in which the fascial adhesions connect the fascial sac to the sclera is called the intra-fascial space.

Figures 9A and 9B show an intraocular shunt placed in an eye using the device of the present invention such that the shunt forms a channel for fluid drainage from the anterior chamber to the intra-fascial space. To place the shunt in the eye, a surgical procedure to implant the shunt is performed, which includes inserting deployment device 200 holding intraocular shunt 201 into eye 202, and deploying at least a portion of shunt 201 within intra-fascial space 208, sub-conjunctival space 209, and under conjunctiva 210. In some embodiments, the hollow shaft 206 of the deployment device 200 holding the shunt 201 enters the eye 202 through the cornea 203 (endo-approach). Shaft 206 is advanced through anterior chamber 204 (as depicted by the dashed lines) in a so-called transpupillary implant insertion. Shaft 206 is advanced through sclera 205 until the distal portion of shaft 206 is proximal to the tenon's capsule 207.

Once the distal portion of the hollow shaft 206 is within the intra-tenon space 208, the shunt 201 is then deployed from the shaft 206 of the deployment device 200, creating a conduit between the anterior chamber 204 and the intra-tenon space 208 to allow aqueous humor to drain from the anterior chamber 204 (see fig. 9A and 9B).

Combinations of embodiments

As will be appreciated by those skilled in the art, individual features of the invention may be used individually or in any combination. In particular, it is contemplated that one or more features of the embodiments described separately above may be combined into one flow splitter.

Is incorporated by reference

References and citations to other documents, such as patents, patent applications, patent publications, periodicals, books, papers, web page content, have been made throughout this disclosure. All of these documents are incorporated herein by reference in their entirety for all purposes.

Equivalents of the same

The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The foregoing embodiments are therefore to be considered in all respects illustrative rather than limiting of the invention described herein.

Claims (13)

1. A device for deploying an intraocular shunt, the device comprising:

a housing;

a hollow shaft coupled to the housing and configured to hold an intraocular shunt;

a plunger slidably disposed within the shaft;

a rotating assembly coupled to the housing and having a first slot and a second slot;

a pusher assembly coupled to the plunger and having a first element within the first slot to couple the pusher assembly with the rotating assembly such that rotation of the rotating assembly causes distal axial movement of the first element to thereby push the plunger in a distal axial direction to partially advance the shunt from within the shaft; and

a retraction assembly coupled to the shaft and having a second element within the second slot to couple the retraction assembly with the rotation assembly such that further rotation of the rotation assembly causes proximal axial movement of the second element to urge the shaft in a proximal axial direction relative to the shunt.

2. The device of claim 1, further comprising an intraocular shunt disposed at least partially within the hollow shaft.

3. The device of claim 1, wherein the distal end of the hollow shaft is beveled.

4. The device of claim 3, wherein the bevel comprises a double bevel.

5. The device of claim 1, wherein the hollow shaft comprises a needle.

6. The device of claim 1, further comprising an indicator mechanism on the housing that provides feedback to an operator regarding the position of the deployment mechanism.

7. The device of claim 6, wherein the indicator comprises a slot formed in the housing for providing a visual indication of the position.

8. The device of claim 1, wherein at least a portion of the first slot and at least a portion of the second slot extend diagonally relative to a longitudinal axis of the rotating assembly.

9. The apparatus of claim 1, wherein the shaft is configured to be at least partially retracted within the housing.

10. The device of claim 9, wherein the shaft is fully retracted within the housing.

11. The device of claim 1, further comprising an intraocular shunt disposed at least partially within the shaft.

12. The device of claim 1, wherein the deployment mechanism further comprises at least one element that limits axial movement of the shaft.

13. The device of claim 1, wherein the distal portion of the housing comprises a sleeve and the hollow shaft is movable within the sleeve.