Intravitreal medicine delivery

• US 5,725,493 A
• Filed: 12/12/1994
• Issued: 03/10/1998
• Est. Priority Date: 12/12/1994
• Status: Expired due to Term

• Current Assignee: Robert L. Avery
• Original Assignee: Jeffrey Kevin Luttrull, Robert Logan Avery
• Inventors: Luttrull, Jeffrey Kevin, Avery, Robert Logan
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): RUHL, DENNIS WILLIAM
• Application Number:
  US08/353,804
• Time in Patent Office: 1,184 Days
• Field of Search: 604/8, 604/9, 604/10, 604/294, 424/427
• US Class Current: 604/9
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61M 2210/0612 Eyes

Abstract

An intravitreal medicine delivery device and method that includes an implant device through which a wide variety of beneficial medicines including drugs or other pharmacological agents can be introduced into the vitreous cavity over an extended period of time with only a single initial surgery to implant the device. The device and method minimize the surgical incision needed for implantation and avoid future or repeated invasive surgery or procedures. Additional amounts of the initial medicine can readily be introduced or the medication can be varied or changed, as required. Furthermore, the device and method allow the dosage delivered to the vitreous cavity to be controlled, and the device is constructed so as to filter medicines delivered to the cavity and also avoids damage to or interference with other parts of the eye during implantation or during use.

Claims

1. An intravitreal medicine delivery device for delivering medicine to the vitreal cavity of an eye having an eyeball covered by conjunctiva, comprising reservoir means for holding a supply of medicine, means for enabling passage of medicine out of the reservoir means, and means for attaching both the reservoir means and the enabling means under the conjunctiva of an eye so that the entire device is under the conjunctiva, said enabling means being adapted to enable passage of medicine into the vitreal cavity of the eye.

2. The device of claim 1 wherein the reservoir means includes means for filling the reservoir means while the reservoir means and the enabling means both remain under the conjunctiva.

3. The device of claim 2 wherein the reservoir filling means is capable of being visible through the conjunctiva when implanted.

4. The device of claim 1 wherein the reservoir means includes means for pumping medicine into the vitreal cavity.

5. The device of claim 4 wherein the pumping means includes valve means which allows fluid-borne medicine to flow from the reservoir means into the vitreal cavity but restricts fluid flow from the vitreal cavity into the reservoir means, and wherein the pumping means also includes a compressible and expandable portion of the enabling means which upon expansion draws fluid-borne medicine from the reservoir means and upon compression, forces fluid-borne medicine into the vitreal cavity.

6. The device of claim 1 wherein the enabling means includes a fluid passageway having a proximate end in communication with the reservoir means and a distal end adapted for communication with the vitreal cavity, said passageway being resiliently compressible to constrict and expand the passageway thereby to draw fluid-borne medicine from the reservoir means into the passageway through said proximate end and to pump fluid-borne medicine from the passageway out of the distal end into the vitreal cavity, said enabling means further including means for allowing fluid flow out of the reservoir means but restricting flow into the reservoir means.

7. The device of claim 1 wherein the reservoir means includes an anteriorly facing injection port penetrable by an injection needle when the needle is forced into the port but fluid-impervious when the needle is withdrawn, and wherein the attaching means includes means for attaching the reservoir means adjacent to the vitreal cavity at a location anteriorly of the injection port so that said attaching means resists movement of the reservoir means when an injection needle applies force against the port.

8. A device for delivering medicine into the vitreous cavity of an eye including an eyelid and an eyeball, said eye also having conjunctiva and Tenon'"'"'s capsule covering the eyeball, comprising a housing having a reservoir for holding a supply of medicine, a tube having one end connected to the housing in communication with the reservoir and an opposite end, and means for attaching the housing to an eyeball so that the housing and both ends of the tube are under the conjunctiva and Tenon'"'"'s capsule whereby the housing and the tube are covered by the conjunctiva and Tenon'"'"'s capsule, said opposite end of the tube being adapted to project through the eyeball into the vitreous cavity, the housing having wall portions surrounding the reservoir, one of said wall portions including a reservoir refilling means which faces anteriorly of the eye when the housing is attached to the eyeball and which is then accessible to a refilling instrument, said refilling means allowing a refilling instrument to introduce medicine through the conjunctiva and Tenon'"'"'s capsule into the reservoir but preventing medicine from escaping from the reservoir.

9. The delivery device of claim 8 wherein said refilling means has a predetermined marking which after the housing is attached is capable of being visible through the conjunctiva and Tenon'"'"'s capsule exteriorly of the eye when the eyelid is lifted, said marking distinguishing said refilling means to facilitate its location.

10. The delivery device of claim 9 wherein said marking is a color.

11. The delivery device of claim 8 wherein the reservoir refilling means is a port area of a material which is normally fluid-impervious but which can be penetrated by a sharp refilling instrument, and wherein wall portions of the housing are impenetrable to the injection instrument except for said port area.

12. The delivery device of claim 8 wherein said reservoir has an inside and an outside, wherein at least part of the wall portions of the housing is semi-permeable to minimize the pressure differential between the inside and the outside of said reservoir.

13. The device of claim 8 wherein the wall portions include a base wall and a top wall joined to the base wall, said base wall having a curvature generally complementary to the curvature of an eyeball, said top wall including a needle-penetrable and resealable port constituting said refilling means, and a remainder portion, the base wall and the remainder portion of the top wall being impenetrable by an injecting needle.

14. The device of claim 8 wherein the wall portions include a relatively hard base wall impenetrable by a sharp instrument and shaped to fit against an eyeball and a top wall in closely spaced relationship to the base wall to define a minimal height dimension of said reservoir, said reservoir having lateral dimensions relatively much greater than said height dimension, said lateral dimensions extending spherically of the eyeball when the base wall is positioned on the eyeball, and wherein the top wall includes an injection area constituting the refilling means and a medial roof area, said injection area being penetrable by a sharp injection instrument but being reseatable when the instrument is withdrawn, said medial roof area being soft and flexible enough to allow its compressibility toward and away from the base wall, and said top wall being otherwise relatively hard and impenetrable by a sharp injection instrument.

15. An intravitreal medicine delivery device for delivering medicine to the vitreal cavity of an eyeball covered by conjunctiva and within an eye socket, comprising reservoir means for holding a supply of medicine, means for attaching the reservoir means within an eye socket exteriorly of and closely adjacent to the eyeball, means for enabling passage of medicine from the reservoir means into said vitreal cavity, said reservoir means including a relatively low-profile housing having an eyeball-shaped, spherical curvature adapted to fit closely against the eyeball under the conjunctiva and Tenon'"'"'s capsule, said housing including a reservoir having a minimal height dimension measured radially of said curvature and lateral dimensions measured spherically of the housing and being substantially greater than the height dimension, said enabling means including a tube projecting from the housing and having an angular extension for projecting into the vitreal cavity.

16. The device of claim 15 wherein the housing has a medicine injecting port facing outwardly from the housing in the same direction that the tube projects from the housing.

17. An intravitreal medicine delivery device for delivering medicine to the vitreal cavity within an eyeball in the socket of an eye in a living body, comprising a housing having a reservoir capable of containing medicine;

means for attaching the housing within the socket of an eye adjacent to the vitreal cavity of the eyeball;

means for conducting medicine in a fluid medium from the reservoir into the vitreal cavity; and

valve means in the conducting means, actuatable exteriorly of the body in which the eye is located, and having a dosage chamber in communication with said reservoir adapted to communicate with the vitreal cavity through the conducting means, said valve means being actuatable to enable a predetermined dosage of medicine to be collected in the dosage chamber and to be forced therefrom through said conducting means into the vitreal cavity.

18. The device of claim 17 wherein said valve means includes a valve body having an inlet port communicating with the reservoir, an annular outlet port defining a valve seat and spaced from the inlet port, a conical seal having a base connected to the outlet port and a resiliently distendible apical mouth projecting away from the outlet port, said mouth being normally closed when relaxed but opening under internal fluid pressure, said dosage chamber being defined by the space between the closed mouth and the outlet port, a ball between the inlet and outlet ports and adapted to float in fluid in the valve, and a spring between the valve seat and the ball which normally prevents the ball from contacting the valve seat but yields under fluid pressure to cause the ball to contact the valve seat after a predetermined dose of fluid passes through the outlet port into the dosage chamber.

19. An intravitreal medicine delivery device for delivering medicine to the vitreal cavity of an eyeball covered by conjunctiva and within an eye socket, comprising reservoir means for holding a supply of medicine, means for attaching the reservoir means within an eye socket exteriorly of and closely adjacent to the eyeball, means for enabling passage of medicine from the reservoir means into said vitreal cavity, the medicine in the reservoir being incorporated in particulate matter from which it diffuses, said enabling means including means for controlling the diffusion of medicine from the reservoir means into the vitreal cavity while restricting passage of said particulate matter into said cavity.

20. The device of claim 19 wherein the enabling means has a proximate end connected to the reservoir means, and wherein the diffusion controlling means is a semi-permeable member positioned at the proximate end of the enabling means.

21. The device of claim 19 wherein the enabling means has a distal end adapted to project into the vitreal cavity, and wherein the diffusion controlling means is a semi-permeable member positioned at the distal end of the enabling means.

22. The device of claim 21 wherein said distal end is a perforate tubular extension, and wherein said semi-permeable member is positioned in the extension.

23. An intravitreal medicine delivery device for delivering medicine to the vitreal cavity of an eyeball covered by conjunctiva and within an eye socket, comprising reservoir means for holding a supply of medicine, means for attaching the reservoir means within an eye socket exteriorly of and closely adjacent to the eyeball, means for enabling passage of medicine from the reservoir means into said vitreal cavity, and means for restricting passage of materials from the vitreal cavity into the reservoir means and for preventing non-medicinal materials from moving into the vitreous cavity.

24. A device for delivering medication to the vitreous cavity of an eyeball comprising a housing having a plastic wall surrounding a reservoir for holding medication, said wall having a base of a first plastic material impenetrable to an injection instrument and adapted to fit complementarily against an eyeball, a top joined to the base having posterior and anterior portions and including an injection area in the anterior portion, said top being also of said first plastic material except for the injection area, said injection area being of a second plastic material which is penetrable by an injection instrument but which reseats after the instrument is withdrawn, and means connected to the housing in communication with the reservoir and projecting anteriorly away from the housing for insertion into the vitreous cavity of the eyeball for allowing movement of medicine from the reservoir into the vitreous cavity.

25. An intravitreal medicine delivery device for delivering medicine to the vitreal cavity of an eyeball covered by conjunctiva and within an eye socket, comprising reservoir means for holding a supply of medicine, means for attaching the reservoir means within an eye socket exteriorly of and closely adjacent to the eyeball, means for enabling passage of medicine from the reservoir means into said vitreal cavity, the medicine in the reservoir being incorporated in particulate matter, and means for preventing passage of particulate matter from the reservoir means into the vitreal cavity.

26. An intravitreal medicine delivery device for delivering medicine to the vitreal cavity in the eyeball of an eye, comprising a relatively rigid, pre-formed plastic housing substantially all of which is of fluid-impervious material for holding a supply of medicine, said housing having a peripheral edge including anterior and posterior portions joined by opposed lateral portions, an outwardly convex top wall, and an outwardly concave bottom wall adapted to fit against an eyeball, said opposed portions of the peripheral edge being spaced by a lateral distance substantially greater than a height dimension between said top and bottom walls whereby said housing has a flat profile so as to hug an eyeball against which the bottom wall is placed, an elongated tube of fluid-impervious material and of oval cross- section and being connected to the housing in fluid communication therewith, said tube having a major axis and a minor axis, and a fluid-conducting elbow connected to the tube and having a terminal end projecting angularly from the tube for extension into the vitreal cavity of said eyeball, said tube projecting anteriorly of the housing and with its major axis converging anteriorly between the housing and the elbow.

27. An intravitreal medicine delivery device for delivering medicine to the vitreal cavity of an eyeball covered by conjunctiva and within an eye socket, comprising reservoir means for holding a supply of medicine, means for enabling passage of medicine from the reservoir means into said vitreal cavity, means for attaching the reservoir means and the enabling means under the conjunctiva within an eye socket exteriorly of and closely adjacent to the eyeball so that the entire device is under the conjunctiva, the reservoir means having wall means for holding a supply of medicine, the enabling means having wall means providing a passageway through which medicine can pass from the reservoir means to the vitreal cavity, and at least one of said wall means including a resiliently movable portion for applying pressure to move medicine from the reservoir means into the cavity.

28. An intravitreal medicine delivery device for delivering medicine to the vitreal cavity of an eyeball covered by conjunctiva and within an eye socket, comprising reservoir means for holding a supply of medicine, means for attaching the reservoir means within an eye socket exteriorly of and closely adjacent to the eyeball, means for enabling passage of medicine from the reservoir means into said vitreal cavity, the enabling means being a resiliently compressible tube having upper and lower walls defining a passageway which contracts and expands in response to compression and release of the tube and including spaced upper and lower baffles mounted on the upper and lower walls respectively and projecting into the passageway toward the opposite wall to close the passageway when the passageway is contracted but to allow fluid flow when the passageway is expanded.