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CN-122003267-A - Device and method for posterior segment access with accurate positioning and needle penetration depth

CN122003267ACN 122003267 ACN122003267 ACN 122003267ACN-122003267-A

Abstract

The methods and devices described herein are used for a) injecting/delivering fluid to and/or draining/removing fluid from the eye. One of the devices may include a probe including a body having a distal end portion, a needle extending and retracting from an exit location on a side surface of the distal end portion, the needle having a needle conduit, and one or more probe conduits for moving the fluid through the probe, the one or more probe conduits being fluidly coupled with the needle conduit. During use, a portion of the side surface having the exit location is placed adjacent to the surface of the eye and the needle is extended to penetrate the eye and the fluid is injected or expelled through the needle catheter.

Inventors

  • R. Muni
  • A. P. Wenros

Assignees

  • 德雷贡弗莱眼治疗公司
  • 多伦多统一健康中心

Dates

Publication Date
20260508
Application Date
20240711
Priority Date
20230823

Claims (20)

  1. 1. An apparatus for injecting fluid into an eye or expelling fluid from an eye, wherein the apparatus comprises: A probe, the probe comprising: a body having a distal end portion; a needle extending and retracting from an exit location on a side surface of the distal end portion, the needle having a needle catheter, and One or more probe catheters for moving the fluid through the probe, the one or more probe catheters being fluidly coupled to the needle catheter; Wherein, during use, a portion of the side surface having the exit location is placed adjacent to the surface of the eye and the needle is extended to penetrate the eye and the fluid is injected or expelled through the needle catheter.
  2. 2. The apparatus of claim 1, wherein the needle is configured to leave the probe at the exit location substantially perpendicular to a tangent of the side surface.
  3. 3. The apparatus of claim 1 or claim 2, wherein the side surface is concave with a radius of curvature approximately matching a radius of curvature of the sclera.
  4. 4. The device of any one of claims 1-3, wherein a longitudinal axis of the distal end portion is angled from a longitudinal axis of the body.
  5. 5. The apparatus of any one of claims 1-4, wherein the apparatus comprises a needle actuator coupled to the needle and controllable for extending and retracting the needle.
  6. 6. The apparatus of any one of claims 1-5, wherein the apparatus comprises a fluid actuator coupled to the needle and controllable for causing the fluid to move between the one or more probe catheters and the eye through the needle catheter.
  7. 7. The apparatus of any of claims 1-6, wherein the side surface has a boss at the exit location and the needle is configured to extend and retract through the boss, or the side surface has a boss adjacent the exit location and the needle is configured to extend and retract adjacent the boss.
  8. 8. The apparatus of any one of claims 1-7, wherein the one or more probe catheters include an injection catheter and an evacuation catheter, and the probe has a coupler adjustable between fluidly coupling the evacuation catheter to the needle catheter and fluidly coupling the injection catheter to the needle catheter.
  9. 9. The device according to any of claims 1-8, wherein the device further comprises a guiding light source adapted to generate a guiding light beam for illumination, or to indicate when the tip of the needle penetrates into a different layer of the eye by a change in transmitted or reflected light.
  10. 10. The device according to any of claims 1-9, wherein the device further comprises at least one guiding means adapted to perform measurements to determine the position of a target injection or discharge site in the tip of the needle and/or the eye.
  11. 11. The apparatus of any one of claims 1-10, wherein the apparatus further comprises a control unit housed in or remote from the probe, the control unit comprising: An optional display; A memory unit storing software instructions that perform one or more functions; A device interface for receiving measurement data and transmitting control signals for operation of the device; A speaker or vibrator generating an audio signal or vibration corresponding to a device operating parameter and/or the measurement data, wherein the speaker or vibrator is optional; A processor communicatively coupled with any of the memory unit, the interface, the speaker or vibrator, and the display, the processor configured to perform one or more functions when executing software instructions, the one or more functions comprising: Receiving the measurement data; Transmitting the control signal; generating the audio signal or vibration, and Displaying at least a portion of the measurement data on the display, and A power supply for providing power to components of the device.
  12. 12. The apparatus of any one of claims 1-11, wherein the apparatus comprises a pump fluidly coupled with the one or more probe conduits, the pump being controllable to generate injection pressure when injecting the fluid into an eye or to generate discharge pressure when discharging the fluid from an eye.
  13. 13. The apparatus of any one of claims 1-12, wherein the probe further comprises a flange and/or a variable coupler at the exit location to maintain a position or pressure between the side surface and a surface of an eye.
  14. 14. The apparatus of claim 13, wherein the flange and/or the variable coupler further comprises one or more sensors to measure position and/or pressure at one or more points between the side surface of the distal end portion of the probe and the surface of the eye.
  15. 15. The apparatus of any one of claims 1-14, further comprising an injection fluid container and/or an evacuation fluid container coupled to the one or more probe conduits.
  16. 16. The device of any one of claims 1-15, wherein the needle is adapted to extend to a depth within the suprachoroidal space, subretinal space, or intravitreal space of the eye.
  17. 17. The device of any one of claims 1-15, wherein when the eye suffers from a hole-derived retinal detachment (RRD) or retinal tear and the device is adapted to inject a fluid into the suprachoroidal space of the eye to generate a choroidal strap for treating the RRD or retinal tear.
  18. 18. The device of any one of claims 1-17, wherein the fluid comprises a therapeutic fluid comprising any combination of a drug, a gene therapy, a sustained release implant, a viscoelastic, a hydrogel, and a gas.
  19. 19. A method for injecting fluid into an eye or evacuating fluid from an eye, wherein the method comprises: Placing a side surface of a distal end portion of a probe adjacent to a surface of an eye, the probe having a needle with a needle catheter and the needle being retracted; Extending the needle from an exit location on a side surface of a distal end portion of the probe to penetrate an eye, and Fluid is injected or expelled between the probe and the eye through the needle catheter.
  20. 20. The method of claim 19, wherein the method comprises extending the needle substantially perpendicular to a tangent of a side surface of the probe at the exit location.

Description

Device and method for posterior segment access with accurate positioning and needle penetration depth Cross Reference to Related Applications The present application claims priority from U.S. provisional patent application No. 63/578,330 filed on day 23 8 of 2023 and U.S. provisional patent application No. 63/624,372 filed on day 24 of 1 of 2024. U.S. provisional patent application No. 63/578,330 and U.S. provisional patent application No. 63/624,372 are incorporated herein by reference in their entirety. Technical Field The various embodiments described herein relate generally to an apparatus and method for delivering an agent (including a drug) to the posterior segment of the eye (suprachoroidal space or subretinal space) via direct external scleral penetration with accurate positioning and accurate needle depth penetration, such as for minimally invasive suprachoroidal delivery of a viscoelastic agent to repair retinal tears or hole-derived retinal detachments. Background In the past century, repair of aperture-derived retinal detachment (RRD) has evolved tremendously. Although scleral zonal Surgery (SB) was the dominant technique 1 for decades, pars Plana Vitrectomy (PPV) has been the treatment of choice 2 for most procedures since the beginning of the 21 st century. However, the functional outcome after PPV surgery is reported to be inferior to SB 3 and pneumatic retinal fixation 4. Advances in multi-modality imaging technology have demonstrated a high risk of unnecessary structural abnormalities following PPV 5-8. Recent evidence suggests that additional procedures, such as subretinal fluid evacuation 9, using heavy fluid 10, and massive gas packing 11, may be detrimental in some cases. This recognition has led surgeons to modify the techniques not only to achieve single-procedure reattachment, but also to maximize the integrity of the reattachment. Some conventional techniques for suprachoroidal delivery of viscoelastic agents for repair of retinal tears or retinal detachments involve a scleretomy (e.g., incision of the sclera) with or without tissue dissection (manual separation of the choroid and sclera) and direct injection of the viscoelastic agent, or inserting a probe into and through the suprachoroidal space after the incision and injecting the viscoelastic agent once the probe is in the region of the retinal tear. However, these are relatively invasive procedures (with potentially greater risk of bleeding and other complications) that must be performed in the operating room, which increases the cost and delay of the operating room available for use. Thus, there is a need for a minimally invasive technique that does not necessarily need to be performed in an operating room and that can be performed without a scleral incision if performed in the operating room. Similarly, techniques for delivering therapeutic agents such as drugs to the retina and other structures toward the back of the eye (including subretinal space) are either invasive (such as ocular incisions and/or subretinal injections) or non-targeted (such as intravitreal injections), which lead to risks of complications such as dilution of eye damage, vision impairment, and/or therapeutic effects. Thus, there is also a need for a minimally invasive technique for targeted delivery of therapeutic agents to the posterior of the eye via the suprachoroidal and/or subretinal spaces. Disclosure of Invention In one aspect, according to the teachings herein, there is provided at least one embodiment of an apparatus for injecting fluid into or expelling fluid from an eye, wherein the apparatus comprises a probe comprising a body having a distal end portion, a needle extending and retracting from an exit location on a side surface of the distal end portion, the needle having a needle catheter, and one or more probe catheters for moving fluid through the probe, the one or more probe catheters being fluidly coupled with the needle catheter, wherein during use a portion of the side surface having the exit location is placed adjacent to a surface of the eye and the needle is extended to penetrate the eye and fluid is injected or expelled through the needle catheter. In at least one embodiment, the needle is configured to leave the probe at an exit location substantially perpendicular to a tangent of the side surface. In at least one embodiment, the side surface is a concave surface having a radius of curvature that approximately matches the radius of curvature of the sclera. In at least one embodiment, the longitudinal axis of the distal end portion is angled from the longitudinal axis of the body. In at least one embodiment, the apparatus includes a needle actuator coupled to the needle and controllable for extending and retracting the needle. In at least one embodiment, the apparatus includes a fluid actuator coupled to the needle and controllable for causing fluid to move between the one or more probe catheters and the eye through the needle cath