The present invention relates generally to implantable medical devices, and specifically to a retinal prosthesis.
Retinal deficiencies, due to degenerative retinal diseases, are a leading cause of blindness and visual impairment. Implantation of a retinal prosthesis is a technology for restoring some useful vision in individuals suffering from retina-related blindness.
The retina is a multi-layered light-sensitive structure that lines the inner part of the eye. The retina contains photoreceptor cells, for example rods and cones, which capture light and convert light signals into neural signals in the other retinal layers transmitted through the optic nerve to the brain. Rods are responsible for light sensitive, low resolution and night vision, whereas cones are responsible for sharp, high resolution color vision. The cones' highest concentration is in the fovea, which defines the center of the visual axis on the retina, and which allows for maximum acuity of vision.
In some applications of the present invention, apparatus and methods are provided for securing a retinal implant in an eye of a subject. Typically, an anchor is coupled to the retinal implant and is configured to anchor the retinal implant to the retina such that when the implant is implanted on the retina, an anterior portion of the anchor is mounted in an anterior segment of the eye, e.g., in a posterior chamber, typically against a ciliary sulcus of the eye.
The retinal implant is configured to stimulate the retina of the subject suffering from a retinal disease in order to restore at least partial vision in the subject. For some applications, the retinal implant comprises an electrode array for stimulation of the retina, and, optionally, an array of photosensors and/or driving circuitry, configured to receive signals from the photosensors and in response thereto, to drive the electrodes to apply currents to the retina. The retinal implant is typically placed on the retina in an epi-retinal position, and the electrode array typically contacts the retina.
In accordance with some applications of the present invention, the anchor is shaped to define an anterior portion, a posterior portion coupled to and surrounding the retinal implant, and a middle portion extending longitudinally between the anterior portion and the posterior portion. Typically, the middle portion is shaped to define an elastic element, e.g., a helical spring. When the anchor is fully deployed in the eye, the anterior portion is anchored against an anterior segment of the eye, and the elastic element extends longitudinally from the anterior of the eye to the posterior of the eye such that the retinal implant, surrounded by the posterior portion of the anchor, is placed on the retina.
Typically, the apparatus in a fully-compressed state is inserted into the eye through a limbal incision. In the fully-compressed state, the middle portion of the anchor is longitudinally compressed such that a distance between the anterior portion and the posterior portion of the anchor is smaller than a distance between the anterior portion and the posterior portion of the anchor when the apparatus is in an expanded state thereof. For some applications, the apparatus is compressed by a first compressing element, e.g., a first compressing suture, which maintains the apparatus in a compressed state by securing the anterior portion with respect to the posterior portion.
Subsequently to inserting the apparatus into the eye, the anterior portion is anchored to the anterior segment of the eye, e.g., in the posterior chamber, typically against the ciliary sulcus of the eye, typically through at least one haptic, e.g., two haptics, which are coupled to the anterior portion of the anchor. For some applications, the haptics are sutured to the ciliary sulcus of the eye. Anchoring the anterior portion of the anchor to the ciliary sulcus typically stabilizes the retinal implant in the eye and allows subsequent full deployment of the anchor, as described below, and stable implantation of the retinal implant on the retina.
Subsequently to the anchoring of the anterior portion of the anchor, a first portion of the anchor is released by uncoupling the anterior portion of the anchor from the posterior portion of the anchor (typically by removing the first compressing element, e.g., the first compressing suture, that secures the anterior portion of the anchor to the posterior portion of the anchor). Upon removal of the first compressing element, e.g., the first compressing suture, the elastic element is partly released such that a portion of elastic element is extended longitudinally into a vitreous cavity of the eye. Typically, following removal of the first compressing element, e.g., the first compressing suture, a distance of the anterior portion to the posterior portion of the anchor is 30-50% of the distance of the anterior portion to the posterior portion of the anchor following deployment in the eye. Following removal of the first compressing element, e.g., the first compressing suture, the apparatus remains in a partly-compressed state in which a second compressing element, e.g., a second compressing suture, maintains the apparatus in a partly-compressed state by securing a section of the elastic element to the posterior portion.
Subsequently to releasing the first portion of the anchor, the posterior portion of the anchor is grasped by a grasping tool and a second portion of the anchor is released by uncoupling a section of the elastic element from the posterior portion of the anchor (typically by removing the second compressing element, e.g., the second compressing suture, that secures the section of the elastic element to the posterior portion). Removal of the second compressing element, e.g., the second compressing, suture allows extending of the anchor longitudinally to a full implantation length thereof, while lowering the retinal implant onto the retina. Typically, the retinal implant is implanted in an epi-retinal position, such that the electrodes contact the retina and provide stimulation to the retina. Typically, the surgeon has full manual control of the release of the retinal implant during the entire implantation procedure, from the compressed state to the deployed state.
There is therefore provided, in accordance with an Inventive Concept 1 of the present invention, apparatus comprising:
a retinal implant, configured for implantation on a retina of a subject's eye in an epi-retinal position; and
an anchor (a) shaped to define (i) an anterior portion, (ii) a posterior portion coupled to the retinal implant, and (iii) a middle portion extending longitudinally between the anterior portion and the posterior portion, and (b) configured to anchor the retinal implant to the retina such that when the retinal implant is implanted on the retina, the anterior portion of the anchor is mounted against a ciliary sulcus of the eye.
Inventive Concept 2. The apparatus according to Inventive Concept 1, wherein (i) the anterior portion of the anchor comprises an anterior ring, (ii) the posterior portion comprises a posterior ring surrounding the retinal implant, and (iii) the middle portion comprises an elastic element extending longitudinally between the anterior ring and the posterior ring.
Inventive Concept 3. The apparatus according to Inventive Concept 2, further comprising at least one haptic coupled to the anterior ring and configured to extend radially outward from the anterior ring in order to anchor the anterior portion of the anchor to the ciliary sulcus.
Inventive Concept 4. The apparatus according to Inventive Concept 2, wherein the anterior ring has an outer diameter of between 4 and 8 mm.
Inventive Concept 5. The apparatus according to Inventive Concept 2, wherein the elastic element has an unconstrained length that is at least 13 mm.
Inventive Concept 6. The apparatus according to Inventive Concept 5, wherein the unconstrained length of the elastic element is at least 23 mm.
Inventive Concept 7. The apparatus according to Inventive Concept 6, wherein the unconstrained length of the elastic element is less than 40 mm.
Inventive Concept 8. The apparatus according to Inventive Concept 1,
wherein: (a) the apparatus is configured to be inserted into the eye of the subject in a fully-compressed state of the apparatus, and (b) the apparatus is configured to be in an expanded state of the apparatus when the posterior portion is implanted on the retina of eye, and
wherein in the fully-compressed state of the apparatus, the middle portion is longitudinally compressed such that a distance between the anterior portion and the posterior portion is smaller than a distance between the anterior portion and the posterior portion in the expanded state.
Inventive Concept 9. The apparatus according to Inventive Concept 8,
wherein the apparatus is further configured to assume a partly-compressed state following insertion into the eye and prior to implantation on the retina, such that in the partly-compressed state a distance between the anterior portion and the posterior portion (a) is larger than a distance between the anterior portion and the posterior portion in the fully-compressed state and (b) is smaller than a distance between the anterior portion and the posterior portion in the expanded state, and
wherein the apparatus further comprises (i) a first compressing element configured to maintain compression of the apparatus by securing the anterior portion with respect to the posterior portion in the fully-compressed state of the apparatus, and (b) a second compressing element coupled to the posterior portion and configured to maintain compression of the apparatus.
Inventive Concept 10. The apparatus according to Inventive Concept 9,
wherein the middle portion comprises an elastic element extending longitudinally between the anterior portion and the posterior portion, and
wherein the second compressing element is configured to maintain compression of the apparatus by securing a section of the elastic element to the posterior portion in the partly-compressed state of the apparatus.
Inventive Concept 11. The apparatus according to Inventive Concept 9, wherein the first and second compressing elements comprise first and second compressing sutures, respectively.
Inventive Concept 12. The apparatus according to Inventive Concept 11, further comprising a second-compressing-suture balancing element, which is removably coupled to the anterior portion, and which is shaped so as to define a central opening through which the second compressing suture passes.
Inventive Concept 13. The apparatus according to Inventive Concept 12, wherein the second-compressing-suture balancing element is shaped as a crossbar.
Inventive Concept 14. The apparatus according to Inventive Concept 12, wherein respective portions of one or more of the following sutures are coupled to the second-compressing-suture balancing element: the first compressing suture, the second compressing suture, and one or more third sutures that removably couple the second-compressing-suture balancing element to the anterior portion.
Inventive Concept 15. The apparatus according to Inventive Concept 9, wherein the first and second compressing elements comprise first and second compressing clips, respectively.
Inventive Concept 16. The apparatus according to Inventive Concept 9, wherein, in the fully-compressed state a distance of the anterior portion to the posterior portion is 2.5-4 mm.
Inventive Concept 17. The apparatus according to Inventive Concept 16, wherein, in the partly-compressed state the distance of the anterior portion to the posterior portion is 8-15 mm.
Inventive Concept 18. The apparatus according to Inventive Concept 17, wherein, in the deployed state the distance of the anterior portion to the posterior portion is 13-23 mm.
Inventive Concept 19. The apparatus according to Inventive Concept 9, wherein, in the partly-compressed state a distance of the anterior portion to the posterior portion is 30-50% of the distance of the anterior portion to the posterior portion in the deployed state.
Inventive Concept 20. The apparatus according to Inventive Concept 9, wherein, in the deployed state the distance of the anterior portion to the posterior portion is 13-23 mm.
Inventive Concept 21. The apparatus according to any one of Inventive Concepts 1-20, further comprising an intraocular lens (IOL) coupled to the anterior portion of the anchor.
Inventive Concept 22. The apparatus according to any one of Inventive Concepts 1-20, further comprising an intraocular lens (IOL) configured to be coupled to the anterior portion of the anchor.
Inventive Concept 23. The apparatus according to any one of Inventive Concepts 1-20, further comprising at least one haptic coupled to the anterior portion of the anchor and configured to anchor the anterior portion of the anchor to the ciliary sulcus.
Inventive Concept 24. The apparatus according to Inventive Concept 23, wherein the at least one haptic is elastic.
Inventive Concept 25. The apparatus according to Inventive Concept 23, wherein the at least one haptic comprises a leading haptic and a trailing haptic.
Inventive Concept 26. The apparatus according to Inventive Concept 25, wherein a maximum distance between the leading haptic and the trailing haptic is 11-13.5 mm.
Inventive Concept 27. The apparatus according to Inventive Concept 23, further comprising at least one haptic-suture configured to anchor the at least one haptic to the ciliary sulcus.
Inventive Concept 28. The apparatus according to any one of Inventive Concepts 1-20, further comprising a frame surrounding the retinal implant at least in part.
Inventive Concept 29. The apparatus according to any one of Inventive Concepts 1-20, wherein the retinal implant comprises an electrode array comprising electrodes.
Inventive Concept 30. The apparatus according to Inventive Concept 29, wherein the retinal implant further comprises an array of photosensors; and driving circuitry, configured to receive signals from the photosensors and in response thereto, to drive the electrodes to apply currents to the retina.
There is further provided, in accordance with an Inventive Concept 31 of the present invention, apparatus comprising:
a retinal implant, configured for implantation on a retina of a subject's eye in an epi-retinal position; and
an anchor (a) shaped to define (i) an anterior portion, (ii) a posterior portion coupled to the retinal implant, and (iii) a middle portion extending longitudinally between the anterior portion and the posterior portion, and (b) configured to anchor the retinal implant to the retina such that when the retinal implant is implanted on the retina, the anterior portion of the anchor is mounted in a posterior chamber of the eye.
Inventive Concept 32. The apparatus according to Inventive Concept 31, wherein the anchor is configured to anchor the retinal implant to the retina such that when the retinal implant is implanted on the retina, the anterior portion of the anchor is mounted to a ciliary sulcus within the posterior chamber of the eye.
Inventive Concept 33. The apparatus according to Inventive Concept 31, wherein (i) the anterior portion of the anchor comprises an anterior ring, (ii) the posterior portion comprises a posterior ring surrounding the retinal implant, and (iii) the middle portion comprises an elastic element extending longitudinally between the anterior ring and the posterior ring.
Inventive Concept 34. The apparatus according to Inventive Concept 33, further comprising at least one haptic coupled to the anterior ring and configured to extend radially outward from the anterior ring in order to anchor the anterior portion of the anchor within the posterior chamber.
Inventive Concept 35. The apparatus according to Inventive Concept 34, wherein the at least one haptic is configured to extend radially outward from the anterior ring in order to anchor the anterior portion of the anchor to a ciliary sulcus within the posterior chamber.
Inventive Concept 36. The apparatus according to Inventive Concept 33, wherein the anterior ring has an outer diameter of between 4 and 8 mm.
Inventive Concept 37. The apparatus according to Inventive Concept 33, wherein the elastic element has an unconstrained length that is at least 13 mm.
Inventive Concept 38. The apparatus according to Inventive Concept 37, wherein the unconstrained length of the elastic element is at least 23 mm.
Inventive Concept 39. The apparatus according to Inventive Concept 38, wherein the unconstrained length of the elastic element is less than 40 mm.
Inventive Concept 40. The apparatus according to Inventive Concept 31,
wherein: (a) the apparatus is configured to be inserted into the eye of the subject in a fully-compressed state of the apparatus, and (b) the apparatus is configured to be in an expanded state of the apparatus when the posterior portion is implanted on the retina of eye, and
wherein in the fully-compressed state of the apparatus, the middle portion is longitudinally compressed such that a distance between the anterior portion and the posterior portion is smaller than a distance between the anterior portion and the posterior portion in the expanded state.
Inventive Concept 41. The apparatus according to Inventive Concept 40,
wherein the apparatus is further configured to assume a partly-compressed state following insertion into the eye and prior to implantation on the retina, such that in the partly-compressed state a distance between the anterior portion and the posterior portion (a) is larger than a distance between the anterior portion and the posterior portion in the fully-compressed state and (b) is smaller than a distance between the anterior portion and the posterior portion in the expanded state, and
wherein the apparatus further comprises (i) a first compressing element configured to maintain compression of the apparatus by securing the anterior portion with respect to the posterior portion in the fully-compressed state of the apparatus, and (b) a second compressing element coupled to the posterior portion and configured to maintain compression of the apparatus.
Inventive Concept 42. The apparatus according to Inventive Concept 41,
wherein the middle portion comprises an elastic element extending longitudinally between the anterior portion and the posterior portion, and
wherein the second compressing element is configured to maintain compression of the apparatus by securing a section of the elastic element to the posterior portion in the partly-compressed state of the apparatus.
Inventive Concept 43. The apparatus according to Inventive Concept 41, wherein the first and second compressing elements comprise first and second compressing sutures, respectively.
Inventive Concept 44. The apparatus according to Inventive Concept 43, further comprising a second-compressing-suture balancing element, which is removably coupled to the anterior portion, and which is shaped so as to define a central opening through which the second compressing suture passes.
Inventive Concept 45. The apparatus according to Inventive Concept 44, wherein the second-compressing-suture balancing element is shaped as a crossbar.
Inventive Concept 46. The apparatus according to Inventive Concept 44, wherein respective portions of one or more of the following sutures are coupled to the second-compressing-suture balancing element: the first compressing suture, the second compressing suture, and one or more third sutures that removably couple the second-compressing-suture balancing element to the anterior portion.
Inventive Concept 47. The apparatus according to Inventive Concept 41, wherein the first and second compressing elements comprise first and second compressing clips, respectively.
Inventive Concept 48. The apparatus according to Inventive Concept 41, wherein, in the fully-compressed state a distance of the anterior portion to the posterior portion is 2.5-4 mm.
Inventive Concept 49. The apparatus according to Inventive Concept 48, wherein, in the partly-compressed state the distance of the anterior portion to the posterior portion is 8-15 mm.
Inventive Concept 50. The apparatus according to Inventive Concept 49, wherein, in the deployed state the distance of the anterior portion to the posterior portion is 13-23 mm.
Inventive Concept 51. The apparatus according to Inventive Concept 41, wherein, in the partly-compressed state a distance of the anterior portion to the posterior portion is 30-50% of the distance of the anterior portion to the posterior portion in the deployed state.
Inventive Concept 52. The apparatus according to Inventive Concept 41, wherein, in the deployed state the distance of the anterior portion to the posterior portion is 13-23 mm.
Inventive Concept 53. The apparatus according to any one of Inventive Concepts 31-52, further comprising an intraocular lens (IOL) coupled to the anterior portion of the anchor.
Inventive Concept 54. The apparatus according to any one of Inventive Concepts 31-52, further comprising an intraocular lens (IOL) configured to be coupled to the anterior portion of the anchor.
Inventive Concept 55. The apparatus according to any one of Inventive Concepts 31-52, further comprising at least one haptic coupled to the anterior portion of the anchor and configured to anchor the anterior portion of the anchor within the posterior chamber.
Inventive Concept 56. The apparatus according to Inventive Concept 55, wherein the at least one haptic is configured to anchor the anterior portion of the anchor to a ciliary sulcus within the posterior chamber.
Inventive Concept 57. The apparatus according to Inventive Concept 55, wherein the at least one haptic is elastic.
Inventive Concept 58. The apparatus according to Inventive Concept 55, wherein the at least one haptic comprises a leading haptic and a trailing haptic.
Inventive Concept 59. The apparatus according to Inventive Concept 58, wherein a maximum distance between the leading haptic and the trailing haptic is 11-13.5 mm.
Inventive Concept 60. The apparatus according to Inventive Concept 55, further comprising at least one haptic-suture configured to anchor the at least one haptic to a ciliary sulcus with the posterior chamber.
Inventive Concept 61. The apparatus according to any one of Inventive Concepts 31-52, further comprising a frame surrounding the retinal implant at least in part.
Inventive Concept 62. The apparatus according to any one of Inventive Concepts 31-52, wherein the retinal implant comprises an electrode array comprising electrodes.
Inventive Concept 63. The apparatus according to Inventive Concept 62, wherein the retinal implant further comprises an array of photosensors; and driving circuitry, configured to receive signals from the photosensors and in response thereto, to drive the electrodes to apply currents to the retina.
There is still further provided, in accordance with an Inventive Concept 64 of the present invention, a method for implanting apparatus in an eye of a subject, the method comprising:
inserting, into the eye of the subject, apparatus including (a) a retinal implant including an electrode array including electrodes, and (b) an anchor coupled to the retinal implant; and
positioning the apparatus such that (i) an anterior portion of the anchor is anchored within a posterior chamber of the eye, and (ii) the retinal implant is positioned on the retina in an epi-retinal position such that the electrode array contacts the retina.
Inventive Concept 65. The method according to Inventive Concept 64, further comprising anchoring the anterior portion of the anchor to within the posterior chamber by suturing the anterior portion of the anchor to the posterior chamber.
Inventive Concept 66. The method according to Inventive Concept 64, wherein the anterior portion of the anchor includes at least one haptic, and wherein positioning the apparatus such that the anterior portion of the anchor is anchored within the posterior chamber comprises positioning the at least one haptic within the posterior chamber.
Inventive Concept 67. The method according to Inventive Concept 64, wherein positioning the apparatus comprises positioning the apparatus such that the anterior portion of the anchor is anchored against a ciliary sulcus within the posterior chamber of the eye.
Inventive Concept 68. The method according to Inventive Concept 67, further comprising anchoring the anterior portion of the anchor to the ciliary sulcus by suturing the anterior portion of the anchor to the ciliary sulcus.
Inventive Concept 69. The method according to Inventive Concept 67, wherein the anterior portion of the anchor includes at least one haptic, and wherein positioning the apparatus such that the anterior portion of the anchor is anchored against the ciliary sulcus of the eye comprises positioning the at least one haptic against the ciliary sulcus.
Inventive Concept 70. The method according to any one of Inventive Concepts 64-69, wherein inserting the apparatus into the eye comprises inserting the apparatus in a fully-compressed state of the apparatus in which a distance of the anterior portion to a posterior portion of the apparatus is 2.5-4 mm.
Inventive Concept 71. The method according to Inventive Concept 70, further comprising, subsequently to positioning the apparatus such that the anterior portion of the anchor is anchored within the posterior chamber, and prior to positioning the apparatus in an epi-retinal position, partly releasing the fully-compressed anchor by removing a first compressing element coupling the anterior portion to the posterior portion.
Inventive Concept 72. The method according to Inventive Concept 71, wherein partly releasing the anchor comprises releasing the anchor such that a distance of the anterior portion to the posterior portion is 30-50% of the distance of the anterior portion to the posterior portion in a deployed state of the apparatus.
Inventive Concept 73. The method according to Inventive Concept 71, further comprising, subsequently to partly releasing the anchor, releasing a second portion of the anchor such that the distance of the anterior portion to the posterior portion is 13-23 mm.
Inventive Concept 74. The method according to Inventive Concept 73, wherein releasing the second portion of the anchor comprises releasing the second portion of the anchor by removing a second compressing element coupling a middle portion of the anchor to the posterior portion.
Inventive Concept 75. The method according to Inventive Concept 73, wherein releasing the second portion of the anchor comprises releasing the second portion of the anchor by releasing a second compressing element coupled to the posterior portion.
Inventive Concept 76. The method according to any one of Inventive Concepts 64-69, further comprising, coupling an intraocular lens (IOL) to the anterior portion of the anchor.
There is additionally provided, in accordance with an Inventive Concept 77 of the present invention, apparatus configured for insertion into a subject's eye, the apparatus comprising:
a retinal implant configured to be implanted in an epi-retinal position on a retina of the eye;
an anchor configured to anchor the retinal implant to the retina, and shaped to define (i) an anterior portion, (ii) a posterior portion surrounding the retinal implant, and (iii) an elastic element extending longitudinally between the anterior portion and the posterior portion;
a first compressing element configured to maintain compression of the apparatus by securing the anterior portion with respect to the posterior portion; and
a second compressing element coupled to the posterior portion and configured to maintain compression of the apparatus.
Inventive Concept 78. The apparatus according to Inventive Concept 77, wherein the second compressing element is configured to maintain compression of the apparatus by securing a section of the elastic element to the posterior portion.
Inventive Concept 79. The apparatus according to Inventive Concept 77, wherein the first and second compressing elements comprise first and second compressing sutures, respectively.
Inventive Concept 80. The apparatus according to Inventive Concept 79, further comprising a second-compressing-suture balancing element, which is removably coupled to the anterior portion, and which is shaped so as to define a central opening through which the second compressing suture passes.
Inventive Concept 81. The apparatus according to Inventive Concept 80, wherein the second-compressing-suture balancing element is shaped as a crossbar.
Inventive Concept 82. The apparatus according to Inventive Concept 80, wherein respective portions of one or more of the following sutures are coupled to the second-compressing-suture balancing element: the first compressing suture, the second compressing suture, and one or more third sutures that removably couple the second-compressing-suture balancing element to the anterior portion.
Inventive Concept 83. The apparatus according to Inventive Concept 77, wherein the first and second compressing elements comprise first and second compressing clips, respectively.
Inventive Concept 84. The apparatus according to Inventive Concept 77, wherein (i) the anterior portion of the anchor comprises an anterior ring, and (ii) the posterior portion comprises a posterior ring surrounding the retinal implant.
Inventive Concept 85. The apparatus according to Inventive Concept 84, further comprising at least one haptic coupled to the anterior ring and configured to extend radially outward from the anterior ring in order to anchor the anterior portion of the anchor within a posterior chamber of the eye.
Inventive Concept 86. The apparatus according to Inventive Concept 85, wherein the at least one haptic is configured to extend radially outward from the anterior ring in order to anchor the anterior portion of the anchor to a ciliary sulcus within the posterior chamber of the eye.
Inventive Concept 87. The apparatus according to Inventive Concept 85, wherein the at least one haptic is elastic.
Inventive Concept 88. The apparatus according to Inventive Concept 84, wherein the anterior ring has an outer diameter of between 4 and 8 mm.
Inventive Concept 89. The apparatus according to any one of Inventive Concepts 77-84, further comprising at least one haptic coupled to the anterior portion of the anchor and configured to stabilize the anterior portion of the anchor within a posterior chamber of the eye.
Inventive Concept 90. The apparatus according to Inventive Concept 89, wherein the at least one haptic is configured to extend radially outward from the anterior ring in order to anchor the anterior portion of the anchor against a ciliary sulcus within the posterior chamber of the eye.
Inventive Concept 91. The apparatus according to Inventive Concept 89, wherein the at least one haptic is elastic.
Inventive Concept 92. The apparatus according to Inventive Concept 89, wherein the at least one haptic comprises a leading haptic and a trailing haptic.
Inventive Concept 93. The apparatus according to Inventive Concept 92, wherein a maximum distance between the leading haptic and the trailing haptic is 11-13.5 mm.
Inventive Concept 94. The apparatus according to Inventive Concept 89, further comprising at least one haptic-suture configured to anchor the at least one haptic to a ciliary sulcus within the posterior chamber of the eye.
Inventive Concept 95. The apparatus according to any one of Inventive Concepts 77-84, further comprising an intraocular lens (IOL) coupled to the anterior portion of the anchor.
Inventive Concept 96. The apparatus according to any one of Inventive Concepts 77-84, further comprising an intraocular lens (IOL) configured to be coupled to the anterior portion of the anchor.
Inventive Concept 97. The apparatus according to any one of Inventive Concepts 77-84, further comprising a frame, surrounding the retinal implant at least in part.
Inventive Concept 98. The apparatus according to any one of Inventive Concepts 77-84, wherein the retinal implant comprises an electrode array comprising electrodes.
Inventive Concept 99. The apparatus according to Inventive Concept 98, wherein the retinal implant further comprises an array of photosensors; and driving circuitry, configured to receive signals from the photosensors and in response thereto, to drive the electrodes to apply currents to the retina.
Inventive Concept 100. The apparatus according to any one of Inventive Concepts 77-84, wherein a distance of the anterior portion to the posterior portion is 2.5-4 mm when (i) the anterior portion is secured with respect to the posterior portion by the first compressing element, and (ii) the second compressing element maintains compression of the apparatus.
Inventive Concept 101. The apparatus according to any one of Inventive Concepts 77-84, wherein the anterior portion of the anchor further comprises a rotational-force reduction element configured to reduce a rotational force applied by the elastic element to the retinal implant upon removal of the second compressing element, when the anterior portion of the anchor and the retinal implant are held rotationally stationary with respect to each other.
Inventive Concept 102. The apparatus according to Inventive Concept 101, wherein:
the rotational-force reduction element comprises a rotational-force reduction ring at an anterior end of the elastic element, and
the rotational-force reduction element is configured to rotate with respect to the anterior ring upon removal of the second compressing element.
Inventive Concept 103. The apparatus according to Inventive Concept 102, wherein the rotational-force reduction ring is a first rotational-force reduction ring, and wherein the rotational-force reduction element further comprises a second rotational-force reduction ring, coupled to the first rotational-force reduction ring and inhibited from rotation with respect to the first rotational-force reduction ring.
Inventive Concept 104. The apparatus according to Inventive Concept 103, wherein the elastic element extends from the rotational-force reduction ring to the posterior portion.
Inventive Concept 105. The apparatus according to Inventive Concept 104, wherein:
the second rotational-force reduction ring is shaped to define a protrusion,
the first rotational-force reduction ring is shaped to define a hole,
the anterior ring is shaped to define a slit, and
the protrusion passes through the hole in the first rotational-force reduction ring and through the slit in the anterior ring.
There is yet additionally provided, in accordance with an Inventive Concept 106 of the present invention, a method for implanting, in an eye of a subject, apparatus having (A) a retinal implant configured for implantation on a retina of the subject, and (B) an anchor coupled to the retinal implant and configured to anchor the retinal implant to the retina, the anchor including (i) an anterior portion, (ii) a posterior portion surrounding the retinal implant, and (iii) an elastic element extending longitudinally between the anterior portion and the posterior portion, the method comprising:
inserting the apparatus through a limbal incision into the subject's eye;
subsequently to the inserting, anchoring the anterior portion of the anchor against a portion of the eye;
subsequently to the anchoring, releasing a first portion of the anchor by uncoupling the anterior portion of the anchor from the posterior portion of the anchor;
subsequently to releasing the first portion of the anchor, grasping the posterior portion of the anchor by a grasping tool;
using the grasping tool, positioning the apparatus in an epi-retinal position; and
releasing a second portion of the anchor.
Inventive Concept 107. The method according to Inventive Concept 106, wherein the anterior portion of the anchor includes at least one haptic, and wherein anchoring the anterior portion of the anchor against the anterior portion of the eye comprises anchoring the at least one haptic against the portion of the eye.
Inventive Concept 108. The method according to Inventive Concept 106, wherein anchoring the anterior portion of the anchor against the portion of the eye comprises anchoring the anterior portion of the anchor to the portion of the eye by suturing the anterior portion of the anchor to the portion of the eye.
Inventive Concept 109. The method according to Inventive Concept 106, wherein anchoring the anterior portion of the anchor comprises anchoring the anterior portion of the anchor within a posterior chamber of the eye.
Inventive Concept 110. The method according to Inventive Concept 109, wherein anchoring the anterior portion of the anchor comprises anchoring the anterior portion of the anchor against a ciliary sulcus within the posterior chamber of the eye.
Inventive Concept 111. The method according to Inventive Concept 109, wherein the anterior portion of the anchor includes at least one haptic, and wherein anchoring the anterior portion of the anchor within the posterior chamber comprises anchoring the at least one haptic against a ciliary sulcus within the posterior chamber of the eye.
Inventive Concept 112. The method according to Inventive Concept 109, wherein anchoring the anterior portion of the anchor within the posterior chamber comprises anchoring the anterior portion of the anchor within the posterior chamber by suturing the anterior portion to a ciliary sulcus within the posterior chamber.
Inventive Concept 113. The method according to Inventive Concept 106, wherein anchoring the anterior portion of the anchor comprises anchoring the anterior portion of the anchor against one or more portions of the eye selected from the group consisting of: a ciliary sulcus of the eye and a pars plana of the eye.
Inventive Concept 114. The method according to Inventive Concept 106, wherein inserting the apparatus through the limbal incision comprises inserting, through the limbal incision, a cannula in which the apparatus is removably disposed, and deploying the apparatus from the cannula into the subject's eye.
Inventive Concept 115. The method according to Inventive Concept 106, wherein inserting the apparatus into the eye comprises inserting the apparatus in a fully-compressed state of the apparatus in which a distance of the anterior portion to a posterior portion of the apparatus is 2.5-4 mm.
Inventive Concept 116. The method according to Inventive Concept 106, wherein releasing the first portion of the anchor by uncoupling the anterior portion of the anchor from a posterior portion comprises removing a first compressing suture.
Inventive Concept 117. The method according to any one of Inventive Concepts 106-116, wherein releasing the first portion of the anchor comprises releasing the anchor such that a distance of the anterior portion to the posterior portion is 8-15 mm.
Inventive Concept 118. The method according to Inventive Concept 117, wherein releasing the first portion of the anchor comprises releasing the anchor such that a distance of the anterior portion to the posterior portion is 30-50% of the distance of the anterior portion to the posterior following releasing of the second portion.
Inventive Concept 119. The method according to any one of Inventive Concepts 106-116, wherein releasing the second portion of the anchor comprises uncoupling a section of the elastic element from the posterior portion of the anchor.
Inventive Concept 120. The method according to Inventive Concept 119, wherein releasing the second portion of the anchor by uncoupling the section of the elastic element from the posterior portion comprises removing a second compressing suture.
Inventive Concept 121. The method according to any one of Inventive Concepts 106-116, further comprising holding a second compressing suture taut from outside the eye to hold the apparatus in a partially-compressed state after releasing the first portion of the anchor, the second compressing suture coupled to the posterior portion of the anchor.
Inventive Concept 122. The method according to Inventive Concept 121, wherein releasing the second portion of the anchor comprises releasing tension, from outside the eye, from the second compressing suture, and subsequently decoupling the second compressing suture from the posterior portion of the anchor.
Inventive Concept 123. The method according to any one of Inventive Concepts 106-116, wherein the posterior portion is shaped to define at least one loop and wherein grasping the posterior portion comprises grasping the at least one loop.
Inventive Concept 124. The method according to any one of Inventive Concepts 106-116, further comprising coupling an intraocular lens (IOL) to the anterior portion of the anchor.
There is also provided, in accordance with an Inventive Concept 125 of the present invention, apparatus configured for insertion into a subject's eye, the apparatus comprising:
a retinal implant configured to be implanted on a retina in an epi-retinal position;
an anchor configured to anchor the retinal implant to the retina, and shaped to define (i) an anterior portion comprising an anterior ring, (ii) a posterior portion surrounding the retinal implant, and (iii) an elastic element extending longitudinally between the anterior portion and the posterior portion;
a compressing element configured to maintain compression of the apparatus by securing a section of the elastic element to the posterior portion; and
a rotational-force reduction element configured to reduce a rotational force applied by the elastic element to the retinal implant upon removal of the compressing element, when the anterior portion of the anchor and the retinal implant are held rotationally stationary with respect to each other.
Inventive Concept 126. The apparatus according to Inventive Concept 125, wherein the compressing element comprises a compressing suture.
Inventive Concept 127. The apparatus according to Inventive Concept 125, wherein the compressing element comprises a compressing clip.
Inventive Concept 128. The apparatus according to any one of Inventive Concepts 125-127, wherein:
the rotational-force reduction element comprises a rotational-force reduction ring at an anterior end of the elastic element, and
the rotational-force reduction element is configured to rotate with respect to the anterior ring upon removal of the compressing element.
Inventive Concept 129. The apparatus according to Inventive Concept 128, wherein the rotational-force reduction ring is a first rotational-force reduction ring, and wherein the rotational-force reduction element further comprises a second rotational-force reduction ring, coupled to the first rotational-force reduction ring and inhibited from rotation with respect to the first rotational-force reduction ring.
Inventive Concept 130. The apparatus according to Inventive Concept 129, wherein the elastic element extends from the rotational-force reduction ring to the posterior portion.
Inventive Concept 131. The apparatus according to Inventive Concept 130, wherein:
the second rotational-force reduction ring is shaped to define a protrusion,
the first rotational-force reduction ring is shaped to define a hole,
the anterior ring is shaped to define a slit, and
the protrusion passes through the hole in the first rotational-force reduction ring and through the slit in the anterior ring.
There is further provided, in accordance with an Inventive Concept 132 of the present invention, apparatus comprising:
a retinal implant configured to be implanted on a retina of an eye in an epi-retinal position; and
an anchor (a) shaped to define (i) an anterior portion, (ii) a posterior portion surrounding the retinal implant, and (iii) a middle portion extending longitudinally between the anterior portion and the posterior portion, and (b) having a distance between the anterior portion and the posterior portion that is 20-40 mm when the anchor is unconstrained.
Inventive Concept 133. The apparatus according to Inventive Concept 132, wherein (i) the anterior portion of the anchor comprises an anterior ring, (ii) the posterior portion comprises a posterior ring surrounding the retinal implant, and (iii) the middle portion comprises an elastic element extending longitudinally between the anterior ring and the posterior ring.
Inventive Concept 134. The apparatus according to Inventive Concept 132 or Inventive Concept 133, further comprising at least one haptic coupled to the anterior portion of the anchor and configured to anchor the anterior portion of the anchor to a portion of the eye.
The present invention will be more fully understood from the following detailed description of embodiments thereof, taken together with the drawings, in which:
Reference is first made to
Anchor 60 is typically shaped to define (i) an anterior portion 70, (ii) a posterior portion 90 surrounding retinal implant 40, and (iii) a middle portion 80 extending longitudinally between anterior portion 70 and posterior portion 90. As shown in
Optionally, the struts of elastic element 82 are coated with a material configured to prevent the buildup of fibrin or other biological material on the struts.
For some applications, anterior portion 70 further comprises at least one haptic 74, e.g., two haptics 74. Typically, anterior portion 70 is configured to be anchored against an anterior segment 308 of the eye by anchoring haptics 74 to the eye. For some applications, haptics 74 are anchored to the eye by expanding and applying a force to the eye. Additionally, or alternatively, haptics 74 are anchored to anterior segment 308 of the eye by passing a haptic-suture through holes 76, and subsequently suturing haptics 74 to the eye. Typically, a maximum distance between haptics 74 once implanted is 11-13.5 mm. Typically, anterior portion 70 (e.g., haptics 74) is flexible in order to allow or facilitate placement of the anterior portion (e.g., the haptics) within the eye. Typically, the thickness and/or shape of haptics 74 are configured to prevent excessive pressure on the eye tissue and/or accommodate a range of eye sizes; for example, haptics 74 may be elastic in order to provide these properties.
For some applications, an intraocular lens (IOL) 100 is coupled to anterior portion 70 of anchor 60. IOL 100 is typically fitted into anterior portion 70 following deployment of apparatus 20 in the eye of the subject.
Typically, posterior portion 90 surrounds retinal implant 40. Retinal implant 40 comprises an electrode array 120 comprising electrodes 122 which are configured to stimulate retina 306 by applying currents to the retina. A view of electrode array 120 is shown in
For some applications, such as shown in the figures, retinal implant 40 additionally comprises an array of photosensors 96 and driving circuitry 98 configured to receive signals from photosensors 96 and in response thereto, to drive electrodes 122 to apply currents to the retina. Alternatively, retinal implant 40 does not comprise the array of photosensors 96, and photosensors 96 are instead disposed outside of the eye, e.g., as an element of an extraocular imaging device (i.e., a camera), for example using techniques described in US Patent Application Publication 2014/0222103 to Lauritzen et al. and/or U.S. Pat. No. 6,458,157 to Suaning, both of which are incorporated herein by reference. Alternatively or additionally, retinal implant 40 does not comprise driving circuitry 98 or comprises only minimal circuitry. For example, techniques may be used that are described in U.S. Pat. No. 5,024,223 to Chow and/or U.S. Pat. No. 5,895,415 to Chow et al., both of which are incorporated herein by reference.
Anchor 60 typically anchors retinal implant 40 such that when anchor 60 is fully deployed in the eye, anterior portion 70 is anchored against anterior segment 308 of the eye, and elastic element 82 extends longitudinally from the anterior of the eye to the posterior of the eye such that retinal implant 40, surrounded by posterior portion 90 of anchor 60, is stably placed on the retina.
Reference is made to
Reference is now made to
As shown in
Typically, anterior ring 72 has an outer diameter of at least 4 mm, no more than 8 mm, and/or between 4 and 8 mm, such as at least 6 mm, no more than 7 mm, and/or between 6 and 7 mm, which is smaller than the diameter of the eye at the transverse section passing through ciliary sulcus 310.
For some applications, in addition to anterior ring 72, anterior portion 70 additionally comprises a rotational-force reduction element 68 at an anterior end of elastic element 82 comprising a first rotational-force reduction ring 79 and a second rotational-force reduction ring 78, coupled to first rotational-force reduction ring 79 and inhibited from rotation with respect to first rotational-force reduction ring 79.
Typically, rotational-force reduction element 68 is configured to rotate and to reduce a rotational force stored in elastic element 82 that might otherwise be applied to retinal implant 40 during implantation. In other words, rotational-force reduction element 68 typically allows some rotation of elastic element 82, while retinal implant 40 remains stationary. Typically, elastic element 82 extends from first rotational-force reduction ring 79 to posterior portion 90 of anchor 60.
Typically, when anchor 60 is in the assembled state (as illustrated in
Reference is now made to
Apparatus 20 is maintained in the fully-compressed state by at least one compressing element, e.g., a suture and/or a clip. The at least one compressing element includes a first compressing element 178, such as a first compressing suture 180, which is used to compress apparatus 20. For some applications, first compressing element 178, e.g., first compressing suture 180, is configured to secure anterior portion 70 with respect to posterior portion 90 to compress apparatus 20, such that a distance of anterior portion 70 to posterior portion 90 is 2.5-4 mm.
Reference is first made to
Reference is now made to
Reference is now made to
Typically, following the cutting of first compressing element 178, e.g., first compressing suture 180, a distance of anterior portion 70 of anchor 60 to posterior portion 90 of anchor 60, is 30-50%, e.g., 40%, of the distance of anterior portion 70 to posterior portion 90 of anchor 60 following deployment of apparatus 20 in the eye.
Following removal of first compressing element 178, e.g., first compressing suture 180, the apparatus remains in a partly-compressed state, shown in
Arrows 126 and 128 schematically indicate helical and posterior motion, respectively, of apparatus 20 following removal of first compressing element 178, e.g., first compressing suture 180, as apparatus 20 assumes the configuration shown in
It is noted that second compressing suture 182 is not shown in in
In the partly-compressed state, second compressing element 181, e.g., second compressing suture 182, typically passes through holes 84 in respective helical legs 282 of elastic element 82 and secures a section of elastic element 82 to posterior portion 90 of anchor 60. Thus, second compressing element 181, e.g., second compressing suture 182, maintains apparatus 20 in the partly-compressed state by securing a section of elastic element 82 to posterior portion 90 of anchor 60 as shown in
As shown in
Reference is now made to
Reference is now made to
As shown in
Reference is now made to
In addition, when anchor 60 is deployed as shown in
Reference is now made to
Reference is now made to
In order to reduce such torsional forces from causing rotation to implant 40 during and subsequently to implantation on the retina, as described hereinabove with reference to
For some applications, apparatus 20 additionally comprises posterior rotational-force reduction element 69 in posterior portion 90. Rotational-force reduction element 69 is typically configured to allow rotation of elastic element 82 while implant 40 remains stationary. Rotational-force reduction element 69 is generally the same as corresponding anterior rotational-force reduction element 68. Rotational-force reduction element 69 typically comprises a frame 44 (shown in
Reference is now made to
Anchor 460 is typically shaped to define (i) anterior portion 470, (ii) posterior portion 490 surrounding retinal implant 40, and (iii) a middle portion 480 extending longitudinally between anterior portion 470 and posterior portion 490. As shown in
For some applications, anterior portion 470 further comprises at least one haptic 474, e.g., two haptics 474, which may be anchored to anterior segment 308 of the eye as described hereinabove regarding haptics 74. Typically, a maximum distance between haptics 474 once implanted is 11-13.5 mm. Typically, anterior ring 472 has an outer diameter of at least 4 mm, no more than 8 mm, and/or between 4 and 8 mm, such as at least 6 mm, no more than 7 mm, and/or between 6 and 7 mm, which is smaller than the diameter of the eye at the transverse section passing through ciliary sulcus 310.
For some applications, IOL 100 is coupled to anterior portion 470 of anchor 460. IOL 100 is typically fitted into anterior portion 470 following deployment of apparatus 420 in the eye of the subject.
Typically, posterior portion 490 surrounds retinal implant 40, which is described hereinabove with reference to
Reference is again made to
Apparatus 420 is maintained in the fully-compressed state by at least one compressing element, e.g., a suture and/or a clip. The at least one compressing element includes a first compressing element 578, such as a first compressing suture 580, which is used to compress apparatus 420. For some applications, first compressing element 578, e.g., first compressing suture 580, is configured to secure anterior portion 470 with respect to posterior portion 490 to compress apparatus 420, such that a distance of anterior portion 470 to posterior portion 490 is 2.5-4 mm.
In addition, second compressing element 581, e.g., a second compressing suture 582, is coupled to posterior portion 490, e.g., to posterior ring 492, such as during manufacture of apparatus 420. Optionally, second compressing suture 582 is coupled to posterior portion 490 via a posterior connecting suture 586 (e.g., second compressing suture 582 may be tied or otherwise coupled to posterior connecting suture 586). Posterior connecting suture 586 may be looped through hooks or rings 588 of posterior portion 490. Alternatively, second compressing suture 582 is directly coupled to posterior portion 490, such as by having a portion of second compressing suture 582 looped through hooks or rings 588.
For some applications, a second-compressing-suture balancing element 590 is provided that is removably coupled (e.g., by one or more sutures) to anterior portion 470, e.g., anterior ring 472. (Second-compressing-suture balancing element 590 is shown in broken view in the enlargement in
For some applications, respective portions of one or more of the sutures described hereinabove are coupled (e.g., tied) to second-compressing-suture balancing element 590. Removal of second-compressing-suture balancing element 590, as described hereinbelow with reference to
Include a statement about removal of all sutures together after placement on the retina (all tied to the crossbar or equivalent). All the sutures can be tied to the bone, and at the end of the procedure the bone is freed and all the sutures are removed from the eye in one step.
Reference is first made to
Apparatus 420 is typically inserted through a limbal incision in the eye, typically following removal of the native lens and vitreous body of the eye. For some applications, apparatus 420 is inserted through the limbal incision by grasping the apparatus by one of haptics 474 and pushing the apparatus through the limbal incision. Alternatively, an insertion tool is used to insert apparatus 420 through the limbal incision. For example, the insertion tool may comprise a cannula in which the apparatus is removably disposed. The cannula is inserted through the limbal incision and the apparatus is deployed from the cannula within the eye.
Reference is now made to
Reference is now made to
Typically, upon the above-described partial release of elastic element 482, a distance of anterior portion 470 of anchor 460 to posterior portion 490 of anchor 460, is 30-60%, e.g., 40%, of the distance of anterior portion 470 to posterior portion 490 of anchor 460 following deployment of apparatus 420 in the eye. In this partly-compressed state, a distance between anterior portion 470 and posterior portion 490 (a) is larger than a distance between anterior portion 470 and posterior portion 490 in the fully-compressed state of apparatus 420, and (b) is smaller than a distance between anterior portion 470 and posterior portion 490 in the expanded state, i.e., following deployment in the eye, of apparatus 420. Typically, in the partly-compressed state the distance of anterior portion 470 to posterior portion 490 is 8-15 mm.
Arrows 526 and 528 schematically indicate helical and posterior motion, respectively, of apparatus 420 following removal of first compressing element 578, e.g., first compressing suture 580, as apparatus 420 assumes the configuration shown in
As shown in
Reference is now made to
Reference is now made to
As shown in
In addition, when anchor 460 is deployed as shown in
Reference is now made to
Reference is now made to
The features of anchor 660 may also be combined with the features of anchor 60, described hereinabove with reference to
Anchor 660 is typically shaped to define (i) an anterior portion 670, (ii) a posterior portion 690 surrounding retinal implant 40 (not shown in
Elastic element 682 is configured such that during the transition from the fully-compressed state to the partially-compressed state, such as described hereinabove with reference to
For some applications, as shown
Reference is still made to
For some applications, techniques and apparatus described in the following patents and patent applications are combined with techniques and apparatus described herein: U.S. Pat. No. 8,150,526 to Gross et al.; U.S. Pat. No. 9,265,945 to Gross et al.; U.S. Pat. No. 8,718,784 to Gefen et al.; U.S. Pat. No. 8,428,740 to Gefen et al.; U.S. Pat. No. 8,442,641 to Gross et al.; U.S. Pat. No. 8,706,243 to Gefen et al.; U.S. Pat. No. 9,198,753 to Gefen et al.; U.S. Pat. No. 10,226,625 to Weinberger et al.; US Patent Application Publication 2018/0117329 to Degtiar et al.; and PCT Publication WO 2018/083699 to Degtiar et al. In case of conflict between the definitions used herein and those used in the patents and patent application publications listed above or incorporated by reference elsewhere herein, the definitions used herein shall control.
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.
The present patent application claims priority from U.S. Provisional Application 62/665,652, filed May 2, 2018, which is assigned to the assignee of the present application and incorporated herein by reference.
Filing Document | Filing Date | Country | Kind |
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PCT/IL2019/050484 | 5/1/2019 | WO | 00 |
Number | Date | Country | |
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62665652 | May 2018 | US |