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JP-7857302-B2 - Method and apparatus for subretinal injection

JP7857302B2JP 7857302 B2JP7857302 B2JP 7857302B2JP-7857302-B2

Inventors

  • ニールス アレクサンダー アプト
  • レト グリューエブラー

Assignees

  • アルコン インコーポレイティド

Dates

Publication Date
20260512
Application Date
20220113
Priority Date
20210125

Claims (7)

  1. A device for subretinal injection into the subretinal space between the retina and the retinal pigment epithelium of the eye: An injection needle having a proximal end and a distal end, wherein the distal end is configured to be insertable into the subretinal space at a certain position on the surface of the retina; A multi-lumen tube having a distal end connected to the proximal end of the injection needle and a proximal end connected to a fluid control unit, the multi-lumen tube having a first lumen and a second lumen; A stabilizer configured to immobilize the injection needle at a certain position on the surface of the retina; and a fluid control unit comprising a first fluid reservoir containing a non-treatment solution and a second fluid reservoir containing a treatment solution, wherein the fluid control unit is configured to inject the non-treatment solution from the first fluid reservoir into the subretinal space via a first lumen, and the fluid control unit is configured to inject the treatment solution from the second fluid reservoir into the subretinal space via a second lumen, The stabilizer includes a balloon, which is expanded by filling it with liquid, and in the expanded position, the balloon has first and second wings that extend substantially along an axis perpendicular to the longitudinal axis of the distal end of the multi-lumen tube. The balloon has a flattened profile such that the width of the balloon, measured parallel to the surface of the retina, is at least twice as large as the height of the balloon, measured perpendicular to the surface of the retina. The multi-lumen tube further includes a third lumen, the stabilizer is coupled to the distal end of the third lumen, and a fluid applied through the third lumen is configured to extend the stabilizer beyond the distal end of the third lumen, thereby positioning the stabilizer on the surface of the retina .
  2. The apparatus according to claim 1, wherein the fluid control unit further includes a third fluid reservoir, and the fluid control unit is configured to inject working fluid from the third fluid reservoir through the third lumen to expand the stabilizer.
  3. The apparatus according to claim 1, wherein the fluid control unit further includes a pump configured to drive the flows of the non-treatment solution and the treatment solution, respectively, the pump being at least one of a variable displacement control pump, a syringe pump, a peristaltic pump, a venturi pump, a lever-operated pump, a valve-operated pump, or a combination thereof.
  4. The apparatus according to claim 1 , wherein the fluid control unit is attachable to at least one of a surgical microscope or the patient's forehead .
  5. The apparatus according to claim 1, further comprising an inserter device, wherein the multi-lumen tube is positioned through the inserter device.
  6. The apparatus according to claim 5, wherein the inserter device includes a slit extending longitudinally from its proximal end to its distal end, and the inserter device is configured to detach the multi-lumen tube from the multi-lumen tube outside the eye by sliding the multi -lumen tube through the slit.
  7. The apparatus according to claim 5, wherein the inserter device includes an enclosed bore extending longitudinally from its proximal end to its distal end, and the inserter device is configured to remain coupled to the multi -lumen tube outside the eye.

Description

Cross-reference of related applications This application claims the benefit of priority of U.S. Provisional Patent Application No. 63/141,051, filed on 25 January 2021, entitled "METHOD AND APPARATUS FOR SUBRETINAL INJECTION" (inventors Niels Alexander Abt and Reto Gruebler), which is incorporated herein by reference as if it had been fully and completely described herein. Embodiments of this disclosure generally relate to devices for ophthalmic treatment, and more particularly to devices and methods for performing subretinal injection. Subretinal injection generally refers to the injection of fluids or other therapeutic substances or stem cells into the subretinal space between the retina and the retinal pigment epithelium (RPE) of the eye. For example, several eye diseases, including age-related macular degeneration (AMD), retinal degenerative diseases, and genetic defects, can be treated by subretinal injection. A typical implementation requires at least two people to perform a subretinal injection. For example, a leading surgeon may guide the injection instrument, such as a syringe/needle, and visually monitor the injection site, while a skilled surgical assistant pushes the fluid from the syringe and monitors the injection volume. Thus, generally, a first syringe is prepared, equipped with a small-gauge needle and containing a non-therapeutic fluid, such as a balanced salt solution (BSS). In the first step of the procedure, the first syringe is inserted through the retina into the subretinal space. While the surgeon handles the first syringe and visually monitors the injection site, the assistant manually injects the non-therapeutic fluid and monitors the injection volume. The first syringe is then removed from the eye. A second syringe is prepared, equipped with a small-gauge needle and containing a therapeutic fluid, such as a therapeutic agent. In the second step of the procedure, the second syringe is inserted through the retina into the subretinal space, at approximately the same location as the first syringe. While the surgeon handles the second syringe and visually monitors the injection site, an assistant manually injects the therapeutic fluid and monitors the injection volume. Therefore, there are many disadvantages to using a handheld injection device when manually controlling the injection in a two-step process. Some of these disadvantages are described below. Firstly, as mentioned above, administering fluid using a handheld infusion device can lead to retinal tears. In particular, retinal tears can result from inadequate movement of the syringe/needle due to external forces from outside the eye while the needle is being inserted through the retina. These external forces may include inadequate movements by the surgeon handling the syringe or by an assistant manually controlling the fluid injection. Furthermore, manual control of fluid injection, as described above, can have several additional drawbacks. Generally, manual control of fluid injection requires manually pushing down the plunger. For example, manual control of fluid injection can lead to inaccurate injection volumes, which can result in over- or under-dosing, or excessive retinal stretching. In another example, manual control of fluid injection can lead to high flow rates into the subretinal space, potentially damaging the retina or RPE, causing retinal detachment such as rupture, accompanied by retinal morphological changes or RPE atrophy. Yet another example is manual control of fluid injection, which can lead to high shear forces on the needle, potentially harming the bioactivity of various therapeutic agents carried by the injected fluid, such as drugs, stem cells, or viral vectors. Furthermore, as mentioned above, removing the first needle and inserting the second needle through the retina may have additional drawbacks. For example, multiple insertions through the retina may contribute to retinal tearing. In another example, creating two different holes in the retina, one at each injection step, increases the likelihood of fluid leakage from the subretinal space. This is a schematic diagram of an exemplary injection device for subretinal injection according to several embodiments.This is a transverse cross-section of a portion of the eye, showing the retina and retinal pigment epithelium.This is an enlarged cross-sectional view taken along the cross-sectional line of Figure 1A, showing an exemplary multi-lumen tube according to several embodiments.Figure 1A is an isometric view of the upper part of a portion of the injection device.This is a schematic diagram of an exemplary inserter device that may be used with the injection device described herein, according to several embodiments.This is a schematic diagram of another exemplary inserter device that may be used with the injection device described herein, according to several embodiments.Figure 1A is a schematic diagram of an injection device showing an exemplary combined in