Intravitreal medicine delivery

• US 6,251,090 B1
• Filed: 11/02/1998
• Issued: 06/26/2001
• Est. Priority Date: 12/12/1994
• Status: Expired due to Fees

• Current Assignee: Robert L. Avery
• Original Assignee: Jeffrey Kevin Luttrull, Robert Logan Avery
• Inventors: Luttrull, Jeffrey Kevin, Avery, Robert Logan
• Primary Examiner(s): Ruhl, Dennis
• Application Number:
  US09/184,925
• Time in Patent Office: 967 Days
• Field of Search: 604/8-10, 604/294, 604/502, 604/521, 424/427, 623/4-6
• 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 are provided and include 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 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 a reservoir for holding a supply of medicine, the reservoir having a medicine outlet, means for enabling passage of medicine from the outlet into the vitreal cavity of the eye, and means for attaching the device to the eye so that the entire device is implanted under the conjunctiva.

2. The device of claim 1 wherein the reservoir has a portion through which the reservoir can be filled while the reservoir and the outlet both remain under the conjunctiva.

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

4. The device of claim 1 wherein the reservoir includes a pump that enables medicine to be pumped into the vitreal cavity through the outlet.

5. The device of claim 4 wherein the pump includes a valve which allows fluid-borne medicine to flow from the reservoir into the vitreal cavity but restricts fluid flow from the vitreal cavity into the reservoir, and wherein the outlet has a compressible and expandable portion that is part of the pump and which upon expansion draws fluid-borne medicine from the reservoir and upon compression, forces fluid-borne medicine into the vitreal cavity.

6. The device of claim 1 wherein said reservoir includes 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 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 outlet including a tube projecting from the housing and having an angular extension for projecting into the vitreal cavity.

7. The device of claim 6 wherein the housing has a medicine injecting port facing outwardly from the housing in the same direction that the tube projects from the housing.

8. The device of claim 1, wherein the outlet includes a fluid passageway having a proximate end in communication with the reservoir 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 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 outlet further including a valve for allowing fluid flow out of the reservoir but restricting flow into the reservoir.

9. The device of claim 1, wherein the reservoir 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 reservoir has an attachment member adjacent to the vitreal cavity at a location anteriorly of the injection port so that, when the attachment member is attached to the eyeball, movement of the reservoir is resisted when the injection needle applies force again the port.

10. The device of claim 1 wherein there is a valve in the outlet 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 outlet, said valve being actuatable to enable a predetermined dosage of medicine to be collected in the dosage chamber and to be forced therefrom through said outlet into the vitreal cavity.

11. 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 attachment members on the housing adapted to be attached 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 refiner which faces anteriorly of the eye when the housing is attached to the eyeball and which is then accessible to a refilling instrument, said refiller 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.

12. The delivery device of claim 11 wherein said refiller has a predetermined marking which 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 refiller to facilitate its location.

13. The delivery device of claim 12 wherein said marking is a color.

14. The delivery device of claim 11 wherein the reservoir refiner 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.

15. The delivery device of claim 11 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.

16. The device of claim 11 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 refiller, and a remainder portion, the base wall and the remainder portion of the top wall being impenetrable by an injecting needle.

17. A method of delivering medicine to the vitreous cavity of the eye comprising:

establishing a reservoir of medicine on the eyewall and under the conjunctiva, and

providing a passageway joining the reservoir and the vitreous cavity and under the conjunctiva and through which medicine can move from the reservoir to the cavity, the entire reservoir and passageway being thereby under the conjunctiva.

18. The method of claim 17 including:

intermittently introducing medicine into the reservoir while the reservoir remains on the eyeball.

19. The method of claim 18,

wherein the intermittent introduction of medicine involves introducing a quantity of medicine into the reservoir greater than a predetermined single dose thereof, and

further enabling such a predetermined dose of medicine to move into the vitreal cavity at selected intervals between said intermittent introductions of medicine into the reservoir.

20. The method of claim 18 further involving introducing selectively different types of medicines into the reservoir at different times without removing the reservoir from the eyewall.

21. The method of claim 17 including restricting passage of medicine from the reservoir into the vitreous cavity while medicine is being introduced into the reservoir.

22. The method of claim 17 wherein the reservoir has an injection port thereon, wherein establishing the reservoir involves suturing an intravitreal medicine delivery device which includes the reservoir and the injection port on the eyewall under the conjunctiva and Tenon'"'"'s capsule, said device including a fluid conductor and a pump actuatable from externally of the eye, said conductor having a proximate end connected to the reservoir and a distal end, and wherein providing the passageway further involves inserting the distal end into the vitreal cavity and subsequently actuating said pump from externally of the eye to pump fluid from the reservoir into the vitreal cavity.