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WO2025057055A1 - Procédé et appareil pour permettre l'accès à un oeil - Google Patents

Procédé et appareil pour permettre l'accès à un oeil Download PDF

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Publication number
WO2025057055A1
WO2025057055A1 PCT/IB2024/058782 IB2024058782W WO2025057055A1 WO 2025057055 A1 WO2025057055 A1 WO 2025057055A1 IB 2024058782 W IB2024058782 W IB 2024058782W WO 2025057055 A1 WO2025057055 A1 WO 2025057055A1
Authority
WO
WIPO (PCT)
Prior art keywords
attachment
assembly
eye
sclera
ocular
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IB2024/058782
Other languages
English (en)
Inventor
James A. Fleming
Sanjay Jain
Eric Steven KENNEDY
Travis Michael CRAFT
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Janssen Biotech Inc
Original Assignee
Janssen Biotech Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Janssen Biotech Inc filed Critical Janssen Biotech Inc
Publication of WO2025057055A1 publication Critical patent/WO2025057055A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
    • A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
    • A61F9/0026—Ophthalmic product dispenser attachments to facilitate positioning near the eye
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
    • A61B2017/3492—Means for supporting the trocar against the body or retaining the trocar inside the body against the outside of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/00736—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments

Definitions

  • This disclosure relates generally to pharmaceutical devices and related methods for delivering a therapeutic agent, and more particularly to ocular guides and related methods for facilitating needle access to an interior of an eye.
  • the eye is a complex organ with a variety of specialized tissues that provide the optical and neurological processes for vision. Accessing the eye for medical treatment is hindered by the small size and delicate nature of the tissues.
  • the posterior region of the eye including the retina, macula, choroid, and optic nerve, is especially difficult to access due to the recessed position of the eye within the orbital cavity.
  • topical eye drops penetrate poorly into the posterior region, further restricting treatment options.
  • the suprachoroidal space is a potential space in the eye for treatment options.
  • the suprachoroidal space is located between the sclera, which is the outer layer of the eye, and the choroid, which is the inner vascular tunic disposed between the sclera and the retina.
  • the suprachoroidal space extends from the anterior portion of the eye near the ciliary body to the posterior end of the eye near the optic nerve. Normally the suprachoroidal space is not evident due to the close apposition of the choroid to the sclera from the intraocular pressure of the eye. Since there is no substantial attachment of the choroid to the sclera, the tissues separate to form the suprachoroidal space when fluid accumulation or other conditions occur.
  • the suprachoroidal space provides a potential route of access from the anterior region of the eye to treat the posterior region.
  • an ocular access instrument can include an instrument body, an attachment assembly supported by the instrument body, and an actuator assembly supported by the instrument body.
  • the attachment assembly can have an attachment member.
  • the attachment assembly can be movable to an attachment position whereby the attachment member is attached to a sclera of the eye.
  • the actuator assembly can include an abutment member.
  • the actuator assembly can be movable to an actuated position whereby the abutment member bears against the sclera at a location spaced from the attachment member, thereby increasing a distance between the sclera and the choroid so as to create an enlarged suprachoroidal space.
  • FIG. 1 A is a perspective view of an ocular access instrument having an attachment assembly and an actuator assembly, and a needle guide constructed in accordance with one example, the ocular access instrument configured to be placed against an eye;
  • Fig. IB is a perspective view of the ocular access instrument of Fig. 1A shown placed against the eye, having portions cut away to show the attachment assembly in an attachment position and the actuator assembly in an actuated position to create an enlarged suprachoroidal space of the eye;
  • FIG. 1C is a perspective view of the ocular access instrument of Fig. IB, shown with a needle guided through the needle guide and into the enlarged suprachoroidal space;
  • Fig. 2A is an exploded perspective view of the ocular access instrument of Fig. 1A;
  • Fig. 2B is a perspective view of an ocular access instrument constructed in another example
  • Fig. 3 A is a sectional side elevation view of the ocular access instrument of Fig. 1 A, shown disposed against the eye in an initial configuration whereby each of the attachment assembly and the actuator assembly are disposed in a respective initial position;
  • Fig. 3B is a sectional end elevation view of the ocular access instrument of Fig. 3A;
  • Fig. 4A is a sectional side elevation view of the ocular access instrument of Fig. 3A, whereby the attachment assembly is shown in the attachment position, and the actuator assembly is shown in an intermediate position;
  • Fig. 4B is a sectional end elevation view of the ocular access instrument of Fig. 4A;
  • Fig. 5A is a sectional side elevation view of the ocular access instrument of Fig. 4A, whereby the actuator assembly is disposed in an abutment position;
  • Fig. 5B is a sectional end elevation view of the ocular access instrument of Fig. 5A;
  • Fig. 6A is a sectional side elevation view of the ocular access instrument of Fig. 5A, whereby the actuator assembly is disposed in an actuated position to create an enlarged suprachoroidal space;
  • Fig. 6B is a sectional end elevation view of the ocular access instrument of Fig. 6A;
  • Fig. 7A is a sectional side elevation view of the ocular access instrument of Fig. 6A, showing a needle extending through the needle guide and into the suprachoroidal space;
  • Fig. 7B is an enlarged sectional side elevation view of an enlarged portion of Fig. 7A.
  • an ocular access instrument 20 is configured to guide a needle into an enlarged suprachoroidal space 24 defined between the sclera 26 and the choroid 28 of an eye 22 (see Fig. 3A).
  • the eye 22 can be a human eye, or the eye of a nonhuman animal.
  • the ocular access instrument 20 can include an instrument body 30, an attachment assembly 32 supported by the instrument body 30, and an actuator assembly 34 supported by the instrument body 30.
  • the attachment assembly 32 and the actuator assembly 34 are independently movable with respect to the instrument body 30.
  • the attachment assembly 32 is movable in an attachment direction from a respective initial or detachment position shown in Fig. 1A to an attachment position shown in Fig.
  • the actuator assembly 34 is movable in an engagement direction from a respective initial or disengagement position to an actuated position whereby the actuator assembly 34 applies a force to the eye that increases a distance between the sclera 26 and the choroid 28, thereby creating the enlarged suprachoroidal space 24.
  • the actuator assembly 34 is further movable in a disengagement direction from the actuated position to the respective initial or disengagement position.
  • the abutment members 38 are removed from the eye 22, and in particular from the sclera 26.
  • the detachment position can be defined by the initial position of the actuator assembly 34 or any other position of the actuator assembly 34 whereby the at least one abutment member 38 does not apply a force to the eye 22 that is sufficient to create the enlarged suprachoroidal space 24.
  • the ocular access instrument 20 can further include a needle guide 40 that is configured to receive a needle 42 and guide the needle 42 into the enlarged suprachoroidal space 24 to deliver a therapeutic agent into the enlarged suprachoroidal space 24.
  • the attachment assembly 32 can include a handle 44, a pivot shaft 45 that is pivotally attached to the instrument body 30, and the attachment members 36 can extend from the pivot shaft 45.
  • the handle 44 and the pivot shaft 45 can, in combination, define an attachment body 35.
  • the handle 44 and the pivot shaft 45 can be monolithic with each other or discretely attached to each other as desired.
  • the attachment members 36 can be monolithic with the handle 44, or discretely attached to the handle 44 as desired.
  • the attachment assembly 32 can further include a pivot member 46, such as a pivot pin, that pivotally couples the attachment assembly 32, and in particular the handle 44, to the instrument body 30.
  • the pivot pin can extend through the handle 44 and apertures of the instrument body 30 to pivotally couple the attachment assembly 32 to the instrument body 30.
  • the instrument body 30 defines a proximal end 31 and a distal end 33 opposite the proximal end 31 in a distal direction. Conversely, the proximal end 31 is opposite the distal end 33 in a proximal direction.
  • the distal end 33 can be defined by a pair of distal walls 41 that are opposite each other along a transverse direction T.
  • the distal walls 41 can define respective distal ends that, in turn, define seats 58 that are configured to abut the eye 22 during operation. It is appreciated that any suitable sleeves or sheaths can be placed onto the walls 41, and it can still be said that the walls 41 define the abutment members seats 58.
  • the handle 44 can define an engagement surface 48, such that the pivot member 46 is disposed between the engagement surface 48 and the at least one attachment member 36.
  • An attachment force applied to the engagement surface 48 causes attachment assembly 32 to move in the attachment direction from the detachment position to the attachment position.
  • the attachment force applied to the engagement surface 48 of the handle 44 can drive handle 44 to pivot about a pivot axis defined by the pivot member 46 along a first pivot direction from the detachment position to the attachment position.
  • the pivot axis can be a fixed pivot axis that does not move in either of the proximal and distal directions during operation.
  • the attachment direction can be defined by the first pivot direction.
  • the attachment assembly 32 can define at least one stop member 51 such as a pair of stop members 51 that are configured to abut the instrument body 30 so as to limit the amount that the attachment assembly 32 pivots in the first pivot direction.
  • the stop members 51 can extend from the handle 44.
  • the attachment assembly 32 is further movable in a detachment direction from the attachment position to the detachment position.
  • the pivot axis is oriented along a pivot axis direction.
  • the pivot axis direction can be defined by the transverse direction T.
  • the attachment members 36 can extend from the handle 44, and can be disposed adjacent each other along the direction that is defined by the pivot axis.
  • the attachment members 36 can define hooks 37 having sharpened distal tips 39.
  • the hooks 37 can be curved in respective planes that are oriented perpendicular to the direction defined by the pivot axis.
  • pivoting the handle 44 about the pivot axis in the first pivot direction causes the attachment members 36 to be driven into the sclera
  • pivoting the handle about the pivot axis in a second direction opposite the first pivot direction causes the attachment members 36 to be removed from the sclera
  • the actuator assembly 34 includes an actuator member 52, and an actuator shaft 54 that extends from the actuator member 52.
  • the actuator shaft extends from the actuator member 52 generally in a distal direction.
  • the actuator shaft 54 can define abutment members 38 that are configured to abut the eye 22 during operation.
  • the actuator member 52 can extend proximally from a proximal end of the actuator shaft 54, and the abutment members 38 can extend distally from a distal end of the actuator shaft 54.
  • the actuator member 52 and the actuator shaft 54 can, in combination, define an actuator body 53.
  • the actuator member 52 and the actuator shaft 54 can be monolithic with each other or discretely attached to each other as desired.
  • the abutment members 38 can be monolithic with the actuator shaft 54 or can be discretely attached to the actuator shaft 54 as desired.
  • the abutment members 38 can be adjacent each other, and spaced from each other along the pivot axis direction. Thus, the abutment members 38 can be spaced from each other in the same direction along which the attachment members 36 are spaced. The abutment members 38 can be spaced from each other a sufficient distance such that the attachment members 36 are disposed between the abutment members 38.
  • the actuator member 52 is configured to receive an engagement force that causes the actuator assembly 34 to move in the engagement direction.
  • the actuator assembly 34 can be driven to translate along a direction of translation in the engagement direction.
  • the direction of translation can be defined by a distal direction.
  • Movement of the actuator assembly 34 in the engagement direction can cause the actuator assembly 34 to move from the initial position to the actuated position.
  • the actuator assembly 34 is further movable in the disengagement direction, which can be defined by movement or translation of the actuator assembly 34 in a proximal direction opposite the distal direction. Movement of the actuator assembly 34 in the disengagement position causes the actuator assembly 34 to move in a direction from the actuated position toward the initial position.
  • the proximal and distal directions are both oriented along the longitudinal direction L.
  • the longitudinal direction L is oriented substantially perpendicular to the transverse direction T.
  • the actuator assembly 34 can further define a slot 56 that extends through the actuator body 53 along the pivot axis direction, which as described above can be defined by the transverse direction T.
  • the slot 56 can be sized and configured to receive the pivot member 46.
  • the slot 56 can extend through the actuator shaft 54, but can extend through either or both of the actuator shaft 54 and the actuator shaft 54 and the actuator member 52.
  • the slot 56 can be sized to receive the pivot member 46, and can elongate along the engagement and disengagement directions of the actuator assembly 34.
  • the pivot member 46 can be configured to ride in the slot 56 selectively in the engagement and disengagement directions.
  • the slot 56 can be a straight linear slot that is elongate along the longitudinal direction L.
  • pivot member 46 can thus travel in the slot 56 along the longitudinal direction as the actuator assembly 34 moves between the respective initial position and the actuated position.
  • the actuator assembly 34 can include a traveler 57 that is supported by the actuator body 53, and in particular by the actuator shaft 54.
  • the actuator shaft 54 can include at least one wall 55 that defines the at least one abutment member 38.
  • the at least one wall 55 can include opposed walls 55 that are spaced from each other, and the traveler 57 can extend between the walls 55.
  • the opposed walls 55 are configured to be disposed between the distal walls 41 of the instrument body 30.
  • the walls 55 define respective distal ends that, in turn, define the abutment members 38. It is appreciated that any suitable sleeves or sheaths can be placed onto the walls 55, and it can still be said that the walls 55 define the abutment members 38.
  • the slot 56 can extend through the actuator shaft 54, and in particular through each of the opposed walls 55 of the actuator assembly 34.
  • the walls 55 can be spaced from each other along the transverse direction T a distance sufficient to receive the attachment body 35, and in particular the pivot shaft 45 therebetween.
  • the traveler 57 can ride along a ramped cam surface 47 of the attachment body 35, and in particular of the pivot shaft 45, during operation.
  • the ramped cam surface 47 can define a slope along a lateral direction A as the ramped cam surface 47 extends along the longitudinal direction L.
  • the lateral direction A can be oriented substantially perpendicular to each of the longitudinal direction L and the transverse direction T.
  • the ramped cam surface 47 can flare laterally outward as it extends in the proximal direction, and conversely flares laterally inward as it extends in the distal direction.
  • the needle guide 40 can extend from the instrument body 30.
  • the needle guide 40 can be discretely attached to the instrument body 30.
  • the needle guide 40 can be monolithic with the instrument body 30. Either way, it can be said that the needle guide 40 is supported by the instrument body 30.
  • the ocular access instrument 20 can further include an ocular locator 60 that is configured to position the ocular access instrument 20 at a desired location and orientation relative to the eye 22 during operation of the instrument 20 (i.e., during movement of the attachment assembly 32 and the actuator assembly 34).
  • the ocular locator 60 can extend from the instrument body 30.
  • the ocular locator 60 can be monolithic with the instrument body 30 or discretely attached to the instrument body 30 as desired.
  • the ocular locator 60 is configured to abut the eye 22 at a predetermined location of the eye 22 such that the attachment members 36 engage respective the sclera 26 at respective desired locations and the abutment members 38 abut the sclera at respective desired locations (see Fig. IB).
  • the respective desired locations can be posterior of the limbus, such that the needle 42 can be injected into the enlarged suprachoroidal space at a location posterior of the limbus.
  • the ocular locator 60 can be positioned on the anterior hemisphere of the eye 22. For instance, the ocular locator 60 can be positioned about the cornea so that the ocular locator is disposed about the iris.
  • the ocular locator 60 can be configured as an annular body such as an annular ring 62 that surrounds the iris.
  • the ocular locator 60 can be rigidly coupled to the instrument body 30 in one example.
  • the instrument body 30 can be positionally manipulated with respect to the ocular locator 60.
  • the ocular locator 60 can alternatively be configured as a mounting bracket 64 that can be secured to any suitable structure external of the eye 22 as desired.
  • the mounting bracket 64 can be configured to be secured to a speculum, an operating table, or any alternative structure that is fixed with respect to the eye 22.
  • An arm 66 can extend between the mounting bracket 64 and the instrument body 30. The arm 66 can be adjustable so as to define a desired position of the instrument body 30 when the mounting bracket 64 is secured to the structure.
  • the ocular access instrument 20 is shown with the attachment assembly 32 in the respective initial or detachment position and the actuator assembly 34 in the respective initial position.
  • the ocular access instrument 20 can be positioned such that respective distal ends of the distal walls 41 of the instrument body 30 are positioned against the eye 22, such that the seats 58 are disposed against the eye 22, and in particular the sclera 22.
  • the ocular access instrument 20 defines a working region 23 of the eye 22 between the distal walls 41, and in particular between the seats 58.
  • the working region 23 of the eye 22 will define the enlarged suprachoroidal space.
  • the pivot member 46 extends through the instrument body 30 and further through the slot 56 of the actuator assembly 34, such that the pivot member 46 is configured to travel in the proximal direction in the slot 56 as the actuator assembly moves in the engagement direction. Engagement between the pivot member 46 and the instrument body 30 can prevent translation of the attachment assembly 32 relative to the instrument body 30.
  • the pivot member 46 can extend through the slot 56 at or proximate to a distal end of the slot 56. Therefore, abutment between the pivot member 46 and the actuator body 53 at the distal end of the slot 56 can prevent the actuator assembly 34 from being removed from the instrument body 30.
  • the ocular access instrument 20 is configured to maintain the actuator assembly 34 in the respective initial position absence an engagement force applied to the actuator member 52 that urges the actuator assembly 34 to move to the actuated position.
  • the instrument body 30 can support a securement member 70 that is configured to be disposed in a first or distal detent 72a of the actuator body 53, and in particular the actuator member 52.
  • the securement member 70 can be spherically shaped or can define any suitable alternative shape as desired.
  • Mechanical interference between the securement member 70 and the actuator body 53 in the first detent 72a can resist movement of the actuator assembly 34 in the distal direction relative to instrument body 30.
  • abutment between the traveler securement member 70 and the actuator body 30 in the first detent 72a can prevent inadvertent movement of the actuator assembly 34 in the distal direction from the initial position toward the actuated position.
  • the attachment assembly 32 is shown in the attachment position.
  • an attachment force is applied to the handle 44, and in particular to the engagement surface 48 of the handle 44, that is sufficient to cause the handle 44 to pivot about the pivot axis in the first pivot direction with respect to the instrument body 30.
  • the user can apply the attachment force with his or her fingers against the engagement surface 48.
  • the ocular access instrument can be gripped or otherwise engaged by the user with the thumb bearing against the proximal end of the actuator member 52, such as the plunger 68, and one or more the fingers bearing against the engagement surface 48 of the handle 44.
  • the attachment force can thus be provided by the user’s fingers.
  • the attachment force causes the attachment assembly 32 to move in the attachment direction. It should be appreciated that the attachment assembly 32 can be moved in the attachment direction in any suitable alternative manner as desired.
  • the attachment members 36 travel along an arcuate path.
  • the attachment members 36 can be driven into the sclera 26 along the arcuate path.
  • the attachment members 36 attach to the sclera at respective attachment locations 61 of the sclera.
  • the attachment members 36 can be driven into the sclera 26.
  • the attachment members 36 are driven into the sclera 26 along a direction that is substantially tangent to the sclera 26.
  • the sharpened distal tips 39 of the hooks 37 are driven into the sclera 26.
  • the attachment members 36 are driven into but not through the sclera 26.
  • the attachment members 36 are driven into an outer surface of the sclera 26 but not through an inner surface of the sclera that faces the choroid 28 and is opposite the outer surface.
  • the attachment members 36 can be driven through the sclera 26 but not into the choroid 28.
  • the attachment members 36 can enter the outer surface of the sclera 26, extend along a portion of the sclera 26 between the outer and inner surfaces of the sclera 26, and exit the sclera 26 at its outer surface.
  • the attachment members 36 can be positioned no further distal than a plane that 1) is defined by the seats 58, and 2) is oriented perpendicular to the longitudinal direction L.
  • the attachment members 36 can be spaced from the plane in the proximal direction.
  • the stop members 51 abut the instrument body 30, thereby preventing further pivotal movement of the attachment assembly 32 in the first pivot direction with respect to the instrument body 30.
  • abutment of the stop members 51 and the instrument body 30 prevents the attachment assembly 32 from pivoting beyond the attachment position.
  • the engagement surface 48 of the handle 44 can be substantially flush with the instrument body 30.
  • the traveler 57 is translatably fixed to the actuator body 53, movement of the traveler 57 in the distal direction during movement of the attachment assembly 32 to the attachment position causes the actuator assembly 34 to move in the engagement direction relative to the instrument body 30 from the respective initial position to an intermediate position.
  • the engagement direction of the actuator assembly 34 can be defined by a direction of translation.
  • the direction of translation can, in turn, be defined by the distal direction.
  • the actuator assembly 34 moves from its respective initial position to the intermediate position that is spaced from the initial position in the engagement direction, which can be defined by the distal direction.
  • the abutment members 38 are spaced from the eye 22 in the proximal direction (or direction opposite the engagement direction).
  • the actuator assembly 34 can move from the intermediate position to an abutment position whereby the abutment members 38 abut the eye 22, and in particular the sclera 26, at respective abutment locations 63.
  • the abutment locations 36 can defined at respective outermost extents of the working region 23 of the eye.
  • the abutment members 38 can move distally toward and to the eye 22 as the actuator assembly 34 moves in the engagement direction to the abutment position.
  • the actuator assembly 34 can move continuously in the engagement direction from the intermediate position to the actuated position without stopping at the abutment position shown in Fig. 5A-5B.
  • the actuator assembly 34 is configured to receive an engagement force that drives the actuator assembly 34 to move in the engagement direction.
  • the engagement force can be applied to the actuator member 52, and in particular to the plunger 68 as described above.
  • the actuator assembly 34 can be moved in the engagement direction from the intermediate position shown at Figs. 4A-4B to the abutment position shown in Figs. 5A-5B.
  • the actuator assembly 34 can be translated from the intermediate position in the engagement direction to the abutment position.
  • the actuator assembly 34 is movable in the engagement direction from the respective initial position to the abutment position.
  • the abutment position of the attachment assembly 32 is disposed between the respective initial position and the actuated position.
  • the abutment members 38 abut the eye 22 but do not apply a force to the eye 22 sufficient to create an enlarged suprachoroidal space. Therefore, the actuator assembly 34 can be said to be in the disengagement position when the actuator assembly 34 is in the abutment position.
  • the traveler 57 extends from the actuator body 53 and is positionally fixed to the actuator body 53, movement of the actuator assembly 34 in the engagement direction causes the traveler 57 to similarly move in the engagement direction with respect to the ramped cam surface 47. Thus, the traveler 57 moves to a position spaced from the ramped cam surface 47. Because the engagement direction of the actuator assembly 34 can be defined by the distal direction in one example, the traveler 57 moves away from the ramped cam surface 47 in the distal direction as the actuator assembly 34 is moved in the engagement direction after the attachment assembly 32 has been moved to the attachment position.
  • the instrument body 30 defines at least one actuator member that is configured to guide the movement of the actuator assembly 34 between the respective initial position and the actuated position.
  • the actuator member can be configured as at least one guide channel 74.
  • the instrument body 30 includes a pair of guide channels 74 each defined by a respective inner guide wall 78 of the instrument body 30 and an outer guide wall 78 of the instrument body 30.
  • the outer guide wall 78 can be defined by the distal end 33 of the instrument body 30.
  • first and second outer guide walls 78 can be defined by the distal walls 41 of the instrument body, respectively, that cooperate with first and second inner guide walls 78 so as to define first and second actuator guide channels 74.
  • the actuator guide channels 74 can be sized to receive respective ones of the opposed walls 55 of the actuator shaft 54, and guide the opposed walls 55 of the actuator assembly 34 as the opposed walls move 55 during selective movement of the actuator assembly 34 in the engagement and disengagement directions.
  • the one or more abutment members 38 defined by the at least one wall 55 can be offset in the proximal direction with respect to the seats 58 defined by the distal end of the instrument body 30 when the actuator assembly 34 is in the abutment position. Nevertheless, both the abutment members 38 and the seats 58 can be in simultaneous contact with the eye 22, and in particular the sclera 26, when the actuator assembly 34 is in the abutment position.
  • the securement member 70 travels proximally along the surface 76 of the actuator body 53 as the actuator assembly 34 moves in the engagement direction from the intermediate position to the abutment position.
  • the securement member 70 travels out of the first or distal detent 72a along the surface 76 toward the second or proximal detent 72b.
  • the securement member 70 is disposed between the first and second detents 72a and 72b when the actuator assembly 34 is in the abutment position.
  • the pivot member 46 disposed in the slot 56 can travel in the slot 56 as the actuator assembly 34 moves in the engagement direction from the intermediate position to the abutment position.
  • the pivot member 46 can move in the slot 56 in a direction opposite the engagement direction.
  • the pivot member 46 can move in the slot in the proximal direction as the actuator member 46 moves in the engagement direction to the abutment position.
  • the slot 56 extends from the pivot member 46 in the proximal direction when the actuator assembly 34 is in the abutment position.
  • the engagement force applied to the actuator assembly 34 can move the actuator assembly in the engagement direction relative to the instrument body 30 and the grip assembly 32 to the actuated position.
  • the abutment members 38 can apply an abutment force to the eye 22, and in particular the sclera 26, in the distal direction.
  • the abutment force applied by the abutment members 38 to the eye 22 can be in an inward direction of (i.e. into) the eye 22.
  • the abutment force applied by the abutment members 38 to the eye 22 is sufficient to displace the sclera 26 and the underlying choroid 28 inwardly or distally to an inwardly displaced position with respect to the attachment locations 61 of the sclera 26 and a region of the sclera 26 immediately adjacent the attachment locations 61.
  • the immediately adjacent region of the sclera 26 can include locations of the sclera 26 between the abutment locations 63 in one example.
  • the attachment locations 61 and immediately adjacent regions of the sclera 26 can be collectively referred to as a select suprachoroidal region.
  • the select suprachoroidal region can be adjacent the abutment locations 63.
  • the attachment members 36 remain positionally fixed as the abutment members 38 move distally with respect to the instrument body 30, the attachment members 36 prevent the sclera 26 from becoming inwardly displaced at the select suprachoroidal region.
  • the attachment members 36 of the attachment assembly 32 are not secured to the choroid 28, the inward displacement of the abutment members 38 against the eye 22 causes a substantial entirety of the choroid 28 at the select suprachoroidal region to become inwardly displaced with respect to the sclera 26 at the select suprachoroidal region. Because the choroid 28 and the sclera 26 separate at the select suprachoroidal region, thereby increasing a distance between the choroid 28 and the sclera 26, the enlarged suprachoroidal region 24 is defined at the select suprachoroidal region.
  • the abutment members 38 move to a position that is distal of the seats 58 defined by the distal end of the instrument body 30. Accordingly, the abutment members 38 can move the eye 22 to a position spaced from the seats 58 in the distal direction. Thus, in some examples, the seats 58 of the instrument body 30 no longer abut the eye 22 when the actuator assembly 34 is in the actuated position.
  • the movement of the abutment members 38 in the distal direction to the actuated position causes the choroid 28 and the sclera 26 to move inwardly at the abutment locations 63 with respect to the sclera 36 at the attachment locations 61.
  • the result is that the choroid 28 moves distally with respect to the sclera 26 at the select suprachoroidal region, thereby separating the sclera 26 and the choroid in the manner described above.
  • the user can elect to pull the instrument body 30, and thus the grip assembly 32, in the proximal direction relative to the actuator assembly 34, which again causes the actuator assembly 34 to move in the distal direction with respect to the instrument body 30 and the grip assembly 32 to the actuated position.
  • the attachment members 36 can pull the sclera 26 proximally away from the choroid 28 in the select suprachoroidal region while the abutment members 38 brace the eye 22 at the abutment locations 63 to precent proximal movement of the choroid at the select suprachoroidal region, thereby causing the sclera 26 and the choroid 28 to separate.
  • the actuator assembly 34 can move distally relative to the eye 22 as described above, while the instrument body 30 is pulled in the proximal direction relative to the actuator assembly 34 as described above. This causes both the abutment members 38 to inwardly displace the eye at the abutment locations 63, and the attachment members 36 to pull the sclera 26 proximally away from the choroid 38. Thus, both the sclera 26 and the choroid 28 can move away from each other to create the separation of the sclera 26 and the choroid 28 at the select suprachoroidal region.
  • the ocular access instrument 20 can be configured to move either or both of the sclera 26 and the choroid 28 away from the other of the sclera 26 and choroid 28, which increases a distance between the sclera 26 and the choroid 28 so as to create the enlarged suprachoroidal space 24.
  • moving either or both of the attachment members 36 and the abutment members 48 can cause either or both of the to move away from the other of the sclera 26 and the choroid 28.
  • the securement member 70 travels proximally along the surface 76 of the actuator body 53 as the actuator assembly 34 moves in the engagement direction from the intermediate position to the abutment position.
  • the securement member 70 travels along the surface 76 and into the second or proximal detent 72b. Mechanical interference between the securement member 70 and the actuator body 53 in the second detent 72b can resist movement of the actuator assembly 34 in the proximal direction relative to instrument body 30.
  • abutment between the traveler securement member 70 and the actuator body 30 in the second detent 72b can prevent inadvertent movement of the actuator assembly 34 in the disengagement direction an amount sufficient to reduce or eliminate the enlarged suprachoroidal space 24.
  • the securement member 70 and the second detent 72b can have substantially matching curvatures, such that the securement member 70 can nest in the second detent 72b.
  • the curvatures can be defined by diameters of respective spheres in some examples.
  • the device can provide either or both of tactile and audible feedback when the actuator assembly is in the actuated position.
  • the second detent 72b can be configured as an elongate channel that is longer along the longitudinal direction than the securement member 70.
  • the second detent 72b can be shaped and configured to prevent the actuator assembly 34 from over-traveling in the direction from the abutment position to the actuated position.
  • the pivot member 46 disposed in the slot 56 can travel in the slot 56 as the actuator assembly 34 moves in the engagement direction from the abutment position to the actuated position.
  • the pivot member 46 can move in the slot 56 in a direction opposite the engagement direction.
  • the pivot member 46 can move in the slot in the proximal direction as the actuator member 46 moves in the engagement direction to the abutment position.
  • the pivot member 46 can be disposed at a proximal end of the slot 56 when the actuator assembly 34 is in the actuated position.
  • the ocular access instrument 20 is configured to prevent further movement of the actuator assembly 34 in the engagement direction after the actuator assembly 34 has been moved to the actuated position, thereby limiting separation forces that are applied to the eye 22 that causes separation between the sclera 26 and the choroid 28.
  • the ocular access instrument 20 can include a needle guide 40 configured to guide a needle 42 to deliver a therapeutic agent into the enlarged suprachoroidal space 24.
  • the needle guide 40 has a needle guide body 86 and a needle guide channel 88 that extends through the needle guide body 86 and is configured to receive the needle 42 and guide the needle 42 into the enlarged suprachoroidal space 24 when the actuator assembly 34 is in the actuated position.
  • the needle guide channel 88 is elongate along a central axis that is aligned with a location that is distal of the sclera 26 in the enlarged suprachoroidal space 24.
  • the location is also distal of the attachment members 36 and the attachment locations 61 of the sclera 26 when the attachment assembly 34 is in the actuated position.
  • the location is also proximal of the choroid 28 in the enlarged suprachoroidal space 24.
  • the central axis of the needle guide channel 88 is configured to extend through the sclera 26 and into the enlarged suprachoroidal space 24 when the actuator assembly 34 is in the actuated position.
  • the central axis of the needle guide channel 88 can define any suitable angle 0 with respect to the longitudinal direction L, and thus with respect to each of the proximal and distal directions, as desired.
  • the angle 0 can be measured in a plane that includes both the central axis of the needle guide channel 88 and the longitudinal direction L.
  • the angle 0 can be between approximately 50 degrees and approximately 90 degrees, such as between approximately 60 degrees and approximately 80 degrees, such as between approximately 70 degrees and approximately 80 degrees. In one particular example, the angle 0 can be approximately 78 degrees.
  • the needle guide 40 can be positionally and angularly fixed to the instrument body 30, thus the angle 0 can be a fixed angle.
  • the fixed angle can be fixed with respect to each of the instrument body 30 and the actuator assembly 34.
  • the needle guide 40 can be positionally and/or angularly adjustable with respect to the instrument body.
  • the needle guide 40 can be attached to the instrument body 30 by an arm that allows the needle guide 40 to be movable in any one or more up to all of the longitudinal direction L, the transverse direction T, and the lateral direction A with respect to each of the instrument body 30 and the actuator assembly 34.
  • the arm can further allow the needle guide 40 to be angularly adjustable relative to the instrument body 30 and the actuator assembly 34 so as to adjust the angle 0 as desired.
  • the angle 0 is suitable such that, after the suprachoroidal space 24 has been created, the needle 42 can be driven through the needle guide channel 88, such that a distal end of the needle 42 pierces the sclera 26 at the enlarged suprachoroidal space 24, and can be driven through the sclera 26 and into the enlarged suprachoroidal space 24.
  • the needle guide channel 88 can guide the needle 42 to be driven into the enlarged suprachoroidal space 24 at the angle 0.
  • a therapeutic agent can then be delivered from the needle 42, for instance from the distal end of the needle 42, and into the enlarged suprachoroidal space 24.
  • a syringe 80 can include a syringe housing 82, and the needle 42 can extend from the syringe housing.
  • the syringe housing 82 can contain a predetermined quantity of the therapeutic agent.
  • the syringe 80 can include a plunger that is driven into the syringe housing 82 to force the predetermined quantity of therapeutic to travel from the syringe housing 82, through the needle 42, and out of the needle into the suprachoroidal space 24.
  • a quantity of therapeutic agent can be continuously delivered into the enlarged suprachoroidal space 24 through the needle 42 using any suitable continuous delivery system.
  • the needle 42 can be removed from the enlarged suprachoroidal space 24 and from the needle channel 88.
  • the ocular access instrument 20 can be removed from the eye.
  • the attachment assembly 32 can be moved from the attachment position to the detachment position whereby the attachment members 38 are removed from the sclera 26.
  • the actuator assembly 34 can be moved from the engagement position to the disengagement position. In one example, movement of the actuator assembly 34 from the abutment position shown in Figs. 6A-6B toward the initial position shown in Figs. 3A-3B can cause the attachment assembly 32 to be moved from the attachment position shown in Figs. 4A-4B to the detachment position shown in Figs. 3A-3B.
  • a user can apply a disengagement force to the actuator member 52 that causes the actuator assembly 34 to move in the disengagement direction opposite the engagement direction.
  • the disengagement force can be applied to the plunger 68.
  • the disengagement direction can be defined by the proximal direction.
  • the actuator assembly 34 can translated in the proximal direction as it moves in the disengagement direction. Movement of the actuator assembly 34 in the disengagement direction relative to the instrument housing 30 and the attachment assembly 32 causes the abutment members 38 to move from the actuated position shown in Figs. 6A-6B to the abutment position shown in Figs. 5A-5B, which removes the abutment force from the abutment members 38 to the eye 22.
  • the enlarged suprachoroidal space 24 can be removed as the ocular access instrument 20 no longer separates the sclera 26 and the choroid 28 from each other.
  • the traveler 57 can move toward the ramped cam surface 47.
  • the traveler can be spaced from the ramped cam surface 47 in the engagement direction of the actuator assembly.
  • the actuator assembly 34 can continue to be driven in the disengagement direction from the abutment position shown in Figs 5A-5B to the intermediate position shown in Figs. 4A-4B. It should be appreciated that movement of the actuator assembly 34 in the disengagement direction from the actuated position to the intermediate position can be continuous. Further, because the traveler 47 is spaced from the ramped cam surface 47, movement of the actuator assembly 34 from the actuated position to the intermediate position does not cause the attachment assembly 32 to move in the detachment direction. As shown in Fig. 4A, the traveler 57 can abut the ramped cam surface 47 when the actuator assembly 34 is in the intermediate position.
  • the ramped cam surface 47 is sloped such that movement of the traveler 57 in the proximal direction while the traveler 57 rides along the ramped cam surface 47 drives the attachment assembly 32 to pivot about the pivot axis in the second pivot direction relative to the instrument body 30. Movement of the attachment assembly 32 in the detachment direction from the attached position causes the attachment members 36 to be removed from the sclera 36 as shown in Figs. 3A-3B. Once the attachment members 36 have been removed from the sclera 36, the ocular access instrument can be removed from the eye 22.
  • either or both of the attachment members 36 can be disposed in a respective catheter.
  • Each catheter can be configured as a sleeve that surrounds the respective attachment member 36.
  • Each attachment members 36 can extend distally out from the catheter.
  • the attachment members 36 can be driven through the sclera in the manner described above, which can cause the catheter to likewise be driven through the sclera.
  • the catheter can be moved distally along the attachment member 36 until the catheter extends through the sclera.
  • Each attachment member 36 can then be withdrawn from the sclera and the catheter, thereby leaving the catheter in place extending through the sclera.
  • Each catheter can thus provide access to the inter-layer space for further blunt dissection and/or delivery of a therapeutic agent to the eye beneath the sclera.
  • the attachment assembly 32 can include attachment members 36 that are configured to be removably attached to the sclera 26 in the manner described herein, it should be appreciated that the attachment members 36 can be alternatively configured as desired.
  • the attachment members 36 can be replaced by a cutting member that includes a cutting blade configured to make an incision into or through the sclera 26 when the attachment assembly moves to the attachment position.
  • a user can have access to the choroid 28 and the suprachoroidal space through the incision as desired.
  • attachment assembly 32 can define any suitable alternative movement as desired from the respective initial position and the attachment position, including but not limited to linear movement along a straight direction, linear movement along a curvilinear direction, or rotational movement.
  • attachment 32 assembly can define any suitable alternative movement as desired from the respective initial position and the attachment position, including but not limited to translational movement along a curvilinear direction, pivotal movement, or rotational movement.

Landscapes

  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Un instrument d'accès oculaire (20) comprend un ensemble de fixation (32) conçu pour venir en prise avec la sclérotique d'un oeil, et un ensemble actionneur (34) conçu pour s'appuyer contre la sclérotique. Lorsque l'ensemble de fixation vient en prise avec la sclérotique, le mouvement de l'ensemble actionneur vers l'intérieur contre l'oeil déplace la choroïde de la sclérotique, créant ainsi un espace suprachoroïdien agrandi. L'instrument d'accès oculaire peut en outre comprendre un guide d'aiguille (40) qui est conçu pour recevoir une aiguille et guider l'aiguille dans l'espace suprachoroïdien agrandi.
PCT/IB2024/058782 2023-09-13 2024-09-10 Procédé et appareil pour permettre l'accès à un oeil Pending WO2025057055A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363582446P 2023-09-13 2023-09-13
US63/582,446 2023-09-13

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WO2025057055A1 true WO2025057055A1 (fr) 2025-03-20

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Application Number Title Priority Date Filing Date
PCT/IB2024/058782 Pending WO2025057055A1 (fr) 2023-09-13 2024-09-10 Procédé et appareil pour permettre l'accès à un oeil

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Country Link
TW (1) TW202525250A (fr)
WO (1) WO2025057055A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008084063A1 (fr) * 2007-01-09 2008-07-17 Fovea Pharmaceuticals Appareil pour injection intraoculaire
WO2016196841A1 (fr) * 2015-06-03 2016-12-08 Aquesys, Inc. Mise en place de shunt intraoculaire ab externo
WO2022136913A1 (fr) * 2020-12-22 2022-06-30 Gyroscope Therapeutics Limited Guide de canule oculaire
WO2022172086A1 (fr) * 2021-02-09 2022-08-18 Gyroscope Therapeutics Limited Dispositif d'injection suprachoroïdien
WO2023228002A1 (fr) * 2022-05-24 2023-11-30 Janssen Biotech, Inc. Guide d'aiguille oculaire et procédé pour faciliter l'accès à un œil

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008084063A1 (fr) * 2007-01-09 2008-07-17 Fovea Pharmaceuticals Appareil pour injection intraoculaire
WO2016196841A1 (fr) * 2015-06-03 2016-12-08 Aquesys, Inc. Mise en place de shunt intraoculaire ab externo
WO2022136913A1 (fr) * 2020-12-22 2022-06-30 Gyroscope Therapeutics Limited Guide de canule oculaire
WO2022172086A1 (fr) * 2021-02-09 2022-08-18 Gyroscope Therapeutics Limited Dispositif d'injection suprachoroïdien
WO2023228002A1 (fr) * 2022-05-24 2023-11-30 Janssen Biotech, Inc. Guide d'aiguille oculaire et procédé pour faciliter l'accès à un œil

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