Intravitreal injection device, system and method
First Claim
Patent Images
1. An intravitreal injection system, comprising:
- a transfer mechanism, said transfer mechanism including a nozzle member and an integral microneedle-guide platform assembly, said microneedle-guide platform assembly having an integral microneedle and an integral guide platform, said nozzle member having an internal formulation chamber that is adapted to receive and contain a pharmacological agent formulation therein, said microneedle having a first end that is in communication with said nozzle member and a second ejection end, said guide platform having an eye contact surface and a predetermined degree of flexibility, whereby said guide platform substantially conforms to the surface of the sclera of an eye and positions said microneedle-guide platform assembly proximate the pars plana area of said eye when in an engagement position thereon, said guide platform further having a lumen disposed centrally thereof that is adapted to receive and guide said microneedle therethrough and into an intravitreal compartment of an eye and suction means that provides an eye engagement force and seals said guide platform to said pars plana area of said eye when said guide platform is in said engagement position,said microneedle-guide platform assembly including anchoring means for anchoring said microneedle in said intravitreal compartment of said eye and microneedle piercing depth means for controlling the penetration depth of said microneedle into said intravitreal compartment of said eye to a range of approximately 0.1-1.0 mm when in said engagement position; and
a jet injector having force generating means that is adapted to generate sufficient force to expel said pharmacological agent formulation from said nozzle member and through said microneedle with an injection pressure in the range of approximately 50-1000 psi.
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Abstract
An intravitreal injection device for administering a pharmacological agent formulation to an intravitreal compartment of an eye, comprising (i) a nozzle member having an internal formulation chamber that is adapted to receive and contain the pharmacological agent formulation therein, (ii) a microneedle having a first end that is in communication with the nozzle member and a second ejection end, (iii) and piercing depth limiter means for limiting the penetration depth of the microneedle into the eye, the microneedle piercing depth limiter means including guide means for positioning the limiter means and guiding the microneedle.
116 Citations
23 Claims
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1. An intravitreal injection system, comprising:
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a transfer mechanism, said transfer mechanism including a nozzle member and an integral microneedle-guide platform assembly, said microneedle-guide platform assembly having an integral microneedle and an integral guide platform, said nozzle member having an internal formulation chamber that is adapted to receive and contain a pharmacological agent formulation therein, said microneedle having a first end that is in communication with said nozzle member and a second ejection end, said guide platform having an eye contact surface and a predetermined degree of flexibility, whereby said guide platform substantially conforms to the surface of the sclera of an eye and positions said microneedle-guide platform assembly proximate the pars plana area of said eye when in an engagement position thereon, said guide platform further having a lumen disposed centrally thereof that is adapted to receive and guide said microneedle therethrough and into an intravitreal compartment of an eye and suction means that provides an eye engagement force and seals said guide platform to said pars plana area of said eye when said guide platform is in said engagement position, said microneedle-guide platform assembly including anchoring means for anchoring said microneedle in said intravitreal compartment of said eye and microneedle piercing depth means for controlling the penetration depth of said microneedle into said intravitreal compartment of said eye to a range of approximately 0.1-1.0 mm when in said engagement position; and a jet injector having force generating means that is adapted to generate sufficient force to expel said pharmacological agent formulation from said nozzle member and through said microneedle with an injection pressure in the range of approximately 50-1000 psi. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. An intravitreal injection device for administering a pharmacological agent formulation to an intravitreal compartment of an eye, comprising:
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a nozzle member having an internal formulation chamber that is adapted to receive and contain the pharmacological agent formulation therein; an integral microneedle-guide platform assembly, said microneedle-guide platform assembly having an integral microneedle and an integral guide platform, said microneedle having a first end that is in communication with said nozzle member and a second ejection end, said guide platform having a lumen disposed centrally thereof that is adapted to receive and guide said microneedle therethrough, said guide platform further having an eye contact surface and a predetermined degree of flexibility, whereby said guide platform substantially conforms to the surface of the scleral membrane of an eye and positions said microneedle and guide platform assembly proximate the pars plana area of said eye when in an engagement position thereon, said integral microneedle-guide platform assembly including microneedle guide means for guiding said microneedle into said scleral membrane of said eye, anchoring means for anchoring said microneedle in said scleral membrane at said pars plana area of said eye, controllable microneedle piercing depth penetration means for limiting the penetration depth of said microneedle into said scleral membrane of said eye, and suction means disposed on said guide platform eye contact surface that provides an eye engagement force and seals said microneedle-guide platform assembly to said pars plana area of said eye when said microneedle-guide platform assembly is in an engagement position on said eye. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19)
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20. A method for administering a pharmacological agent formulation to an intravitreal compartment of an eye, comprising the steps of:
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providing an intravitreal injection system having a transfer mechanism and a jet injector, said transfer mechanism including a nozzle member and an integral microneedle-guide platform assembly, said microneedle-guide platform assembly having an integral microneedle and an integral guide platform, said nozzle member containing the pharmacological agent formulation in an internal formulation chamber, said microneedle having a first end that is in communication with said nozzle member and a second ejection end, said guide platform having an eye contact surface and a predetermined degree of flexibility, whereby said guide platform substantially conforms to the surface of a sclera of the eye when in an engagement position thereon, said guide platform further including suction means that provides an engagement force when said guide platform is in said engagement position on the eye, said guide platform further having a substantially crescent shape that includes a concave edge and a centrally located lumen that is adapted to receive said microneedle and guide said microneedle into said eye when said guide platform is in said engagement position on said eye, said microneedle-guide platform assembly providing a predetermined microneedle penetration depth into said eye in the range of approximately 0.1-1.0 mm when in said engagement position, said jet injector having force generating means that is adapted to generate sufficient force to expel the pharmacological agent formulation from said nozzle member and through said microneedle; coupling said intravitreal injection system to said jet injector, whereby an intravitreal injection assembly is formed; positioning said intravitreal injection assembly on the pars plana area of the eye by mating said concave edge of said crescent shaped platform proximate the junction of the cornea and sclera of the eye; and activating said injector, whereby the pharmacological agent formulation is expelled from said nozzle member, through said microneedle and into the intravitreal compartment of the eye. - View Dependent Claims (21, 22, 23)
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Specification