DEVICES AND METHODS FOR TREATING OCCLUSION OF THE OPHTHALMIC ARTERY

Abstract

There is provided herein a disclosure and specification of invention(s) relating to devices and methods for percutaneous access and treatment of vascular structures in the rear of the eye, including treatment for the symptoms related to Wet Age Related Macular Degeneration by removal of stenosis of the OA, thereby restoring normal, or near normal, blood flow to the rear of the eye, including the retina and associated structures. Also provided herein is a disclosure and specification of invention(s) relating to methods and devices for selective manipulation of Intraocular Pressure (IOP) be means of mechanical force for the purpose of inducing retrograde flow in the ophthalmic vasculature.

Claims

1-7. (canceled)

8. A method of treating an ophthalmic artery, including: inserting a device within an ophthalmic artery; and treating the ophthalmic artery via the device.

9. The method of claim 8, wherein treating the ophthalmic artery includes treating tissue of the ophthalmic artery.

10. The method of claim 9, wherein the tissue includes at least one of debris, tissue of a stenosis, tissue of a lesion, tissue of a restenosis, tissue of an occlusion, other tissue, or material.

11. The method of claim 8, wherein treating the ophthalmic artery includes treating a proximal portion of the ophthalmic artery.

12. The method of claim 8, wherein inserting the device includes accessing the ophthalmic artery via the internal carotid artery, and delivering the device via a catheter positioned at an ostium of the ophthalmic artery.

13. The method of claim 8, wherein the method of treating the ophthalmic artery includes treating an eye disease.

14. The method of claim 13, wherein treating the eye disease comprises treating macular degeneration, glaucoma, or diabetic retimopathy.

15. The method of claim 9, wherein treating tissue includes removing tissue, the method further including opening an obstruction in the ophthalmic artery via a first portion of the device and capturing at least some of the tissue via a second portion of the device.

16. The method of claim 9, wherein treating tissue includes removing tissue, the method further including opening an obstruction in the ophthalmic artery via the device and capturing at least some of the tissue.

17. The method of claim 8, further including applying aspiration to the ophthalmic artery to remove tissue.

18. The method of claim 9, further including, after treating the tissue, withdrawing the device from the ophthalmic artery.

19. The method of claim 8, wherein the device includes at least one of a guide wire, a balloon, or a capture element.

20. The method of claim 19, wherein the capture element removes at least one of debris, tissue of a stenosis, tissue of a lesion, tissue of a restenosis, tissue of an occlusion, other tissue, or material.

21. The method of claim 19, wherein a thickness of the device is less than or equal to 1.4 mm.

22. The method of claim 8, further including inducing retrograde flow in arterial vasculature between the internal carotid artery and the eye.

23. The method of claim 8, further including delivering at least one pharmaceutical compound to the ophthalmic artery via the device.

24. A method of treating an ophthalmic artery, including: percutaneously accessing the ophthalmic artery via an internal carotid artery; positioning at least a portion of a device within the ophthalmic artery, the portion of the device including a balloon; and treating tissue of the ophthalmic artery by expanding the balloon within the ophthalmic artery to increase vascular flow through the ophthalmic artery.

25. The method of claim 24, wherein the expansion of the balloon causes tissue debris.

26. The method of claim 24, further including positioning a distal protection device within the ophthalmic artery.

27. The method of claim 24, wherein positioning at least a portion of a device within the ophthalmic artery includes positioning the at least the portion of the device within a proximal portion of the ophthalmic artery.

28. The method of claim 25, further including capturing the debris and removing the debris from a body of a subject.

29. The method of claim 24, further including, after treating the tissue: deflating the balloon; and removing, from a body of a subject, the device and all other devices that enter the body during the method.

30. The method of claim 24, further including applying aspiration to the ophthalmic artery via the device to remove tissue or material from the ophthalmic artery.

31. The method of claim 24, further including inducing retrograde flow through at least a portion of arterial vasculature between the internal carotid artery and the eye.

32. The method of claim 24, wherein the method of treating an eye includes treating an eye disease.

33. The method of claim 24, wherein positioning the at least a portion of the device within the ophthalmic artery includes delivering the device via a catheter positioned at an ostium of the ophthalmic artery.

34. A method of treating an ophthalmic artery, including: inducing retrograde blood flow in at least a portion of arterial vasculature between the internal carotid artery and the eye; capturing at least a portion of dislodged tissue of the ophthalmic artery via a device positioned in the arterial vasculature; and removing the dislodged tissue from the ophthalmic artery.

35. The method of claim 34, wherein the device is positioned within the ophthalmic artery, the method further including treating tissue of the ophthalmic artery to cause the dislodged tissue.

36. The method of claim 34, wherein the method of treating an eye includes treating an eye disease.

37. The method of claim 34, further including removing the device from a body of a subject.

Description

BRIEF DESCRIPTION OF FIGURES

[0079] FIGS. 1A and 1B are each a semi-transparent perspective side view of an embodiment of the present inventive subject matter.

[0080] FIG. 2 is a semi-transparent perspective side view of another embodiment of the present inventive subject matter.

[0081] FIG. 3A is a photo showing a corewire. FIG. 3B is a photo showing a tapered core wire.

[0082] FIG. 4 is side view of another embodiment of the present inventive subject matter,

[0083] FIGS. 5A and 5B are before and after side views of another embodiment of the present inventive subject matter.

[0084] FIG. 5C is a side view of another embodiment of the present inventive subject matter.

[0085] FIGS. 6A and 6B are a before and after side views of another embodiment of the present inventive subject matter.

[0086] FIGS. 7A-7C are a series of drawings showing a hypotubem atherectomy corewire and expanded atherectomy ballon with distal protect element.

[0087] FIGS. 8A and 8B are side view line drawings of a multicomponent apparatus of the present invention.

[0088] FIGS. 9A and 9B are before and after side views of another embodiment of the present inventive subject matter.

[0089] FIGS. 10A-10C are a series of drawings showing variations in balloon distal elements.

[0090] FIGS. 11A-11C are a series of sequential line drawings showing use of shaped and straight guide wires.

[0091] FIG. 12 is a side view line drawing of an embodiment having an inflatable balloon and a intravascular positioning device/parachute.

[0092] FIG. 13 is a side view line drawing of an embodiment having an inflatable balloon and a intravascular positioning device/parachute.

[0093] FIG. 14 is a variation of a side view line drawing of an embodiment having an inflatable balloon and a intravascular positioning device/parachute.

[0094] FIG. 15 is a variation of a side view line drawing of an embodiment having an inflatable balloon.

[0095] FIG. 16 is a variation of a side view line drawing of an embodiment having an inflatable balloon.

[0096] FIGS. 17A-17E are a series of figures showing anatomy and use of an IOP device.

[0097] FIGS. 18A and 18B are side view line drawings of the eye showing IOP caused by mechanical force.

[0098] FIG. 19 is a front view line drawing of the eye showing IOP caused by mechanical force, with a controller unit for interacting in a continuous or periodic manner,

[0099] FIG. 20 is an anatomical drawing of the eye for reference purposes only.

DETAILED DESCRIPTION OF THE INVENTION

[0100] Without being limited to any specific theory, the invention is based on the premise that the primary causative effect for Wet Age-Related Macular Degeneration (WAMD), glaucoma and diabetic retinopathy is occlusion of the Ophthalmic Artery (OA) such that normal blood flow is restricted (ischemia) to the rear of the eye. As a result of this ischemia, hypoxia (resulting in neovascularization) is induced in these structures and vision eventually devolves into a dysfunctional retina (WAMD). From this, we have identified two designs that may be used to provide a treatment methodology for WAMD. Several variations are detailed later in this specification. These include, 1) a device(s) for performing interventional work in the ophthalmic artery and surrounding structures to restore/increase vascular blood flow and, 2) a device for selectively inducing retrograde blood flow in the retinal vasculature via manipulation for intraocular pressure (TOP).

[0101] Interventional Device

[0102] The interventional device is designed to gain access to and deliver direct mechanical and/or drug therapy to a specific location of the anatomy. While the following examples specifically detail the necessary components for a particular ophthalmic artery (OA) application, this technology may be used in any anatomical location in which removal of material is desired in a luminal environment. This environment may be vascular or not and may be used in any tubal, luminal or other similar anatomical structure where removal of material is desired. As such, the invention can be scaled, modified or constructed such that it can provide therapy for a specific luminal anatomical location/need. The general inventive device design is based on a central wire, hypotube, coil, balloon or combination thereof. The inventive device is made of stainless, nitinol, polymer, other materials or a combination thereof and designed to accommodate specific approaches (carotid, subclavian, femoral, endoscopic or laparoscopic). For the example given, entrance into the body is provided by a vascular access element which may be typical, or may be designed specifically for use with the inventive device (ie: catheter sheath introducer or equivalent). The inventive device fits within a sheath, which is designed to provide a protective element for the device as well as to prevent vessel trauma during delivery to the target site. The distal portion includes the ability to provide distal protection in the OA, as well as an element to provide diametric interference. This area of diametric interference is designed to interface with the target vessel segment (eg; lesion) such that specific and deliberate manipulation provides for the ability to selectively remove material from the lesion site. The diametric interference element also provides for the ability to compress such that it fits within the device sheath to provide a minimal diametric dimension. This diametric portion is also referred to as an interventional element. Once the device is placed at the target anatomy, the interventional element is positioned such that it is outside the sheath and it conformally fits the inner diameter of the target anatomy. The interventional element also contains a design element that allows for tissue removal when manipulated in a specific manner. That manner includes manual rotation, manual push/pull, mechanical rotation, mechanical push/pull, site specific drug delivery or a combination of some or all of those. Additionally, the tissue removal device and conforming element is optionally different devices, two devices or different segments of the same device. Once material removal is complete, the interventional element is pulled into the sheath, along with the distal protection portion (equipped) of the device and the entire assembly removed. It is also possible to remove the interventional element for cleaning and to replace and continue. Furthermore, this device is able to deliver drug therapy directly to the area of intervention. For example, delivery of a pharmaceutical compound to reduce the rate of restenosis may be possible as well as a variety of other pharmaceutical compounds. The device is also constructed such that it is able to provide interventional therapy in the form of energy delivery. This includes, but is not limited to, laser, ultrasound, cryogenic, radiofrequency (RF) and/or other energies or combination thereof. Additionally, there is also the provision for the ability to provide direct optical viewing of the target site prior to, during and after administration of therapy. There is an ability to combine multiple drug therapies for a single condition or multiple conditions. For example, Sirolimus for antiproliferative effect post angioplasty. In addition to this or separate from this, a statin may be included and eluted as lipid like deposits called drusen can be concomitant to Wet AMD. It is presumed that the slow elution of a statin would reduce the size and number of drusen deposits and there by improve eyesight.

[0103] Interventional DeviceCommon Device Elements:

1. Ability to visualize under fluoroscopy
2. Preferred internal carotid access (can be done via subclavian or femoral)
3. Distal protection element in the internal carotid artery (ICA)
4. Distal protection element in the Ophthalmic Artery
5. Works in OA diameter ranges between 0.7 to 1.4 mmderived by atmospheric pressure applied to the conformal element
6. Working length for OA estimated to be about 15 inches, further definitions included
7. Approaches other than ICA also included
8. Ability to remove material from the OA and transport out of the vasculature
9. Ability to induce retrograde flow, either continuously, or on demand for specific time periods.
10. May use of a guiding catheter to cannulate the OA from the ICA (combination of GC features with sheath to have an all in one)

[0104] Interventional DeviceSingular Elements (Specific to a Particular Design):

1. Distal OA protection as an integral element of the device
2. Distal OA protection as a separately placed/removed device
3. Distal CA protection as an integral element of the device
4. Distal CA protection as a separately placed/removed device
5. Distal ICA protection as a integral placed/removed device
6. Distal ICA protection as a separately placed/removed device.
7. Ability to deliver an RF element for therapy
8. Ability to deliver a laser element for therapy
9. Ability to deliver an ultrasound element for therapy
10. Ability to deliver a cryogenic element for therapy
11. Ability to deliver drugs via infusion
12. Ability to deliver drugs via injection (bolusTPA)
13. Drug delivery capability before, during and after material removal
14. Ability to deliver drugs via micro needles

[0105] IA. Interventional DeviceSpecific Examples: Solid Core Wire Based

[0106] FIGS. 1A and 1B show an embodiment of the present invention having an Aspiration Core. The design is based on a solid metallic corewire with integrated aspiration capability. The device consists of the following elements and features as detailed in FIGS. 1A and 1B:

1. Center corewire
2. Longitudinal indentations
3. Delivery sheath
4. Cutting element
5. Distal protection element

6. Atraumatic tip

[0107] FIG. 1A depicts the device with the delivery sheath (3) covering the cutting (4) and distal protection (5) elements, which are both mounted on the central core (1). The tip of the device contains an atraumatic tip (6) to aid in placement of the device.

[0108] FIG. 1B (above) depicts the delivery sheath pulled back and the cutting and distal protection elements both in a deployed position. Aspiration is accomplished by either flushing and aspirating using alternate longitudinal channels (2) of the corewire, or by a combination use of longitudinal channels and the delivery sheath, one for flushing and the other for aspiration. Once the procedure is complete, the device is withdrawn back into the delivery sheath and positioned as seen in FIG. 1A. The device is then safely withdrawn from the anatomy.

[0109] Generally, the overall length of the device is optimized for the anatomical location and approach. In a preferred example, for use within the OA, an overall length of about 160 cm or about 15.00 inches for the device would be used in conjunction with an appropriately designed sheath. The maximum overall diameter of the sheath would be in the 1.0 mm range (after inflation), with the cutting and distal protection elements offering a conformal fit capability in the deployed range of between 0.7 mm to 1.4 mm as dictated by the specific dimensions of the OA and the lesion site. Of course, these overall length and diametric dimensions would be adjusted based on the specific applications and is contemplated as within the scope of the invention. In addition, the specific material composition, formulation and manufacturing parameters of material used would be refined to address the specific application and is contemplated as within the scope of the invention. This dimensional information applies to all of the designs disclosed. In one preferred example, the lesion crossing profile of this device is less than 0.2 mm. A range of appropriate profile dimensions is contemplated as within the scope of the invention.

[0110] A. Interventional DeviceSpecific Examples: Plain CoreNon Aspiration Core

[0111] The design in FIG. 2 is based on a solid corewire and does not have specific aspiration capability. The device consists of the following elements and features:

1. Center corewire
2. Delivery sheath
3. Cutting element
4. Distal protection element

5. Atraumatic tip

[0112] This inventive subject matter of FIG. 2 is essentially the same as the FIG. 1 aspiration core with the exception that the core is note designed to facilitate aspiration. The remaining elements of the device are essentially similar to the aspiration core design. The drawing (above) depicts the delivery sheath pulled back and the cutting and distal protection elements both in a deployed position. Once the procedure is complete, the device is withdrawn back into the delivery sheath and positioned in a similar fashion as seen in the aspiration core FIG. 1A. The device is then safely withdrawn from the anatomy.

[0113] It should also be noted that the corewire based design may include elements that are much simpler in design than illustrated in the sketch above. These designs could include a wire with a specific drawn profile that is inserted into the anatomy such that movement of the wire would allow an interface between the profile of the corewire and the anatomy to facilitate lesion material removal. These particular designs could include 1) a straight as drawn wire, 2) an as drawn wire with a twist or 3) a selective combination of the two.

[0114] FIG. 3A and FIG. 3B depict drawn wire with a twist and the distal tip segment of our initial corewire based prototype design.

[0115] FIG. 4 depicts the initial corewire based prototype overall configuration.

[0116] B. Interventional DeviceHypotube Based

[0117] Integral elementsThe design in FIGS. 5A-5C is based on a hollow metallic tube.

Aspiration capability is not detailed in this sketch, but may be possible with the addition of a central flush source. The device consists of the following elements and features as detailed in FIG. 5A and FIG. 5B:

[0118] 1. Central guidewire 2. Delivery sheath 3. Hollow tube

[0119] 4. Cutting element 5. Distal protection element 6. Abrasives

[0120] FIG. 5A depicts the device with the delivery sheath (2) covering the cutting (4) and distal protection (5) elements, which are both cut from the actual hypotube (3) and as such, are integral to the hypotube

[0121] An alternative version of this design would be a hypotube version with cutting and distal protection elements mounted on the hypotube. There would also be a provision for an element that would be positioned in the lumen after removal of the guidewire. This element would serve to deliver fluid for flushing. In this example, aspiration could be accomplished by applying suction to the proximal hypotube such that fluid is removed as well as debris while flushing is activated. While these inventions are not sketched, this document discloses such configuration). A guidewire (1) extends down the inner lumen of the hypotube to provide a means for navigating the anatomy. Upon placement within the target anatomy, the guidewire is removed and the sheath is pulled back, deploying the cutting and distal protection elements. Deployment of the distal elements is controlled by selective manufacturing processes which preferentially train the elements to behave in a certain fashion such that they exhibit a condition known as shape memory. This shape memory is exhibited by the hypotube when it is in an unrestrained position. Abrasives (6) mounted, coated or integral with the cutting element may be designed to facilitate material removal and shaping of the lesion.

[0122] FIG. 5B depicts the delivery sheath pulled back and the cutting and distal protection elements both in a deployed position. Once the procedure is complete, the device is withdrawn back into the delivery sheath and positioned as seen in FIG. 5A. The device can then be safely withdrawn from the anatomy.

[0123] FIG. 5C depicts an alternative embodiment of the hypotube design. In this example, all elements are similar as in the previous sketch, with the exception of number 7. Element number 7 details a moveable internal core wire, which is joined with inner distal tip of the hypotube such that longitudinal movement of the corewire may serve to either expand elements 4 and 5, or compress them. When the procedure is complete, removal of this device would be accomplished in a similar fashion as describe in Drawing B, above.

[0124] IC. Interventional DevicePolymer Based Tube

[0125] FIG. 6A depicts the device with the delivery sheath (2) covering the cutting element (4), which is cut from the polymer tube (3) and as such, are integral to the tube (Note: an alternative version of this design would include a provision for an element that would be positioned in the lumen after removal of the guidewire. This element would serve to deliver fluid for flushing. In this example, aspiration could be accomplished by applying suction to the proximal sheath such that fluid is removed as well as debris while flushing is activated. While this invention is not sketched, this document discloses such configuration).

[0126] FIG. 6B details a moveable internal corewire (1) which extends down the inner lumen of the tube and is fastened to the distal tip of the device (5) to provide a means for deploying the cutting and distal protection elements through either expansion or contraction. Abrasives (6) mounted, coated or integral with the cutting element may be designed to facilitate material removal and shaping of the lesion.

[0127] ID. Interventional Device

[0128] FIGS. 7A-7C show a Single Hypotube based design in which a puff/pull aspiration of the atherectomy debris is applied. A single hypotube of 0.12 (0.10-0.14) mm with a 0.001 thickness is laser cut and set to expand an atherectomy device and distall protection device. The device is used by puffing saline or another inert liquid into the space while simultaneous (manually or mechanically) aspirating the disease area and applying rotational force (pushing or turning, mechanically or manually) on the lesion. When fully deployed, the device is 1.4 millimeter in maximum diameter.

[0129] E. Interventional Device

[0130] FIGS. 8A and 8B show a basket like atherectomy device, proximal to a POBA/DE Balloon, proximal to a distal protection device. The basket like atherectomy device and distal protection are deployed distal to the lesion. The device is pulled into the catheter, scrapping debris into the basket. As the balloon passes the lesion site after atherectomy an angioplasty is applied, facilitating a smooth, non-striated blood interface.

[0131] IF. Interventional DeviceBalloon Based

[0132] FIG. 9A depicts the device with the delivery sheath (3) covering the balloon catheter body (2) as well as the cutting (6) and distal protection (5) elements, which are both integral with the balloon body (4). (Note: There would also be a provision for an element that would be positioned in the lumen after removal of the guidewire. This element would serve to deliver fluid for flushing. In this example, aspiration could be accomplished by applying suction to the proximal sheath such that fluid is removed as well as debris while flushing is activated. While this invention is not sketched, this document discloses such configuration). A guidewire (1) extends down the inner lumen of the device to provide a means for navigating the anatomy,

[0133] FIG. 9B depicts placement within the target anatomy, where the guidewire is removed and the sheath pulled back, exposing the cutting and distal protection elements. Deployment of the distal elements is controlled by use of an inflation device to fill the balloon with fluid. Once the balloon is inflated, the profile would take shape such that the cutting and distal protection elements are deployed. Abrasives (6) mounted, coated or integral with the cutting element may be designed to facilitate material removal and shaping of the lesion. Hydrogels or other material (5) may be integral to the distal protection element such that material is attracted and adheres to it.

[0134] FIGS. 10A-10C depict some general shapes for the balloon distal elements. These sketches serve to provide only general variation ideas and are not meant to be all inclusive.

[0135] IG. Interventional DeviceOphthalmic Artery Access Element

[0136] FIGS. 11A-11C show the use of a shaped guidewire to access the OA and follow up with a guiding catheter to position within the entry to the OA. Once inside, the shaped guidewire will be exchanged for either a straight guidewire or an interventional device to continue the procedure. FIGS. 11A-11C depict access of the OA by use of a shaped guidewire, entry into the OA by a guiding catheter over the shaped guidewire and finally exchange of the shaped guidewire for either a straight tip guidewire or an interventional device. The guidewire and guiding catheter is specifically designed for use in the OA and may include a provision for providing downstream protection.

[0137] IH. Interventional DeviceFlow Directed 1

[0138] FIG. 12 shows a device that will use the vascular flow to aid in locating and positioning within the OA. There are several features that are detailed here, but all share a common design element in that they are specifically designed for the OA anatomy and will work with the vascular flow to aid in placement and positioning within the anatomy. An additional design provision may include the ability to work with the IOP device (as detailed in section I). In this use, the flow directed element would take into account the reversal of vascular flow and would follow that flow accordingly, which would aid in the removal of the device from the target anatomy. This feature would simplify the removal of the instrument by reducing the amount of force required to withdraw the device. There are several examples of this design as noted by FIG. 12.

[0139] Ii. Interventional DeviceFlow Directed 2

[0140] FIGS. 13-16 describe a simple, flow directed balloon that is unified with a large volume delivery catheter. It is a hybrid guidewire/balloon/aspiration device. Novelty is found in the fact that the flow directed balloon and guidewire are a single unit and that the inner diameter of the lumen starts out at around 7-8 French and narrows dramatically for the last 3-4 cm. Delivery of the device into the ostium of the ophthalmic artery may be done by a catherter, that has a 90 degree port at the ostium of the OA. This allows for the very small diameter (0.19 mm OD or smaller) balloon guidewire to enter into the ophthalmic artery and to be pulled into the artery and across the lesion by normal blood flow. The larger diameter of the inner diameter catheter allows for good pressure to be maintained proximal to the balloon facilitating the delivery of contrast agents in addition to saline for balloon inflation.

[0141] IJ. IOP DeviceGeneral Description

[0142] FIGS. 17A-17E depict the general invention behind the device used to manipulate intra ocular pressures (IOP). One element will fit the patients eye(s) such that it may be used to apply pressure to the front of the eye. The eye portion may be held in position with a strap, adhesive, external member or other method that sufficiently accomplishes the task of keeping the eye portion in proper contact with the patient's eye(s). The eye contact portion of the device may be designed to cover and manipulate a single eye, both eyes, one at a time, two at the same time or any combination. Pressure manipulation of the front of the eye will be accomplished by applying a specified amount of direct pressure to the front (typically corneal) area of the eye. This may be accomplished in a variety of ways, including use of pneumatic, hydraulic, gravity and/or other mechanical means of manipulating force over an area. There may be need to combine these forces in such away as to optimize the pressure manipulation. Use of mechanical force manipulation will provide the best methodology and control for removal of force such that the IOP returns to the normal steady state post procedure in a repeatable, desirable manner. A second element will provide for the IOP measurement of the eye under manipulation. There may be several ways to accomplish IOP measurement. These include remote implantable sensor with wired or wireless data transmission capability, corneal tonometry, non-corneal tonometry and/or transpalpebral tonometry. In addition, there may be other ways to accomplish IOP measurements such that pressure values are obtained from the subject eye. A third element will provide the user (physician) with the ability to select pressure and time for the device to interact with the eye in the form of an external control feature. This external control feature may be in the form of a computer, tablet, smart phone or other device that provides the user with the necessary control and feedback information needed to perform the IOP manipulation. This control feature will also contain a feedback loop which will continuously monitor IOP so that a constant pressure may be maintained. This control mechanism will also allow for ramp up/ramp down of pressure, non-constant pressure, time manipulation and/or any combination thereof. This capability will likely be software driven and will provide the user with the ability to custom tailor an TOP manipulation profile for a specific patient. We think that the rate or pressure induced, time at pressure and rate of pressure reduction will be important to the success of the procedure and will design the control mechanism to provide this capability. In addition, the ability to capture, chart and store patient centric data will be an element of this control mechanism.

[0143] Use of the device elements as detailed above will allow for the physician to induce retrograde vascular flow (for up to 3 minutes at a time) such that when the interventional device is used, the risk for retinal vasculature embolism is reduced. It is known that at a minimum retrograde flow in the central retinal artery can be maintained for antithrombotic protection and possibly the ciliary arteries. With pressure put on the front of the eye, the blood volume of the choroid layers can be forced back, through the central retinal artery, ciliary arteries and possibly lacrimal arteries.

[0144] FIGS. 18A and 18B detail how the force applied to the front of the eye will translate into force flowing through the eye, increasing TOP, resulting in retrograde vascular flow. The drawing also details how the removal of force will result in a return to the normal pressure state of the eye. Note the drawing is not anatomically correct.

[0145] FIG. 19 depicts one embodiment of a feedback loop utilizing an implantable TOP sensor.

[0146] FIG. 20 provides detail associated with the posterior vasculature of the eye. It is for information only.

[0147] The references recited herein are incorporated herein in their entirety, particularly as they relate to teaching the level of ordinary skill in this art and for any disclosure necessary for the commoner understanding of the subject matter of the claimed invention. It will be clear to a person of ordinary skill in the art that the above embodiments may be altered or that insubstantial changes may be made without departing from the scope of the invention. Accordingly, the scope of the invention is determined by the scope of the following claims and their equitable Equivalents.