OCULAR IMPLANT AND METHODS FOR MAKING AND USING SAME

• US 20080161741A1
• Filed: 03/18/2008
• Published: 07/03/2008
• Est. Priority Date: 01/12/2000
• Status: Abandoned Application

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Taylor, Jon B., Bene, Eric A., Mir, Leon, Morrill, Tim J., Mulhern, Margaret B., Wandel, Thaddeus L.
• Application Number:
  US12/050,346
• Publication Number:
  US 20080161741A1
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0087 colour-coded
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61M 27/00 Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202

Abstract

An ocular implant device that is insertable into either the anterior or posterior chamber of the eye to drain aqueous humor and/or to introduce medications. The implant can include a substantially cylindrical body with a channel member that regulates the flow rate of aqueous humor from the anterior chamber or introduces medications into the posterior chamber, and simultaneously minimizes the ingress of microorganisms into the eye.

Claims

1. An ocular implant for fluid communication with an anterior or posterior chamber of an eye, comprising:

a body having a distal end and a proximal end, the body extending from at least one of an anterior and a posterior chamber to an outer surface of an eye;

a head defining an opening and positioned at the proximal end of the body for engagement against the outer surface of the eye;

a foot defining an opening and positioned at the distal end of the body for engagement within at least one of an anterior and posterior chamber;

a channel in the body communicating with respective openings in the head and the foot; and

a flow restrictor in the channel located at an intermediate position, disposed distally with respect to the head and proximally with respect to the foot; and

a flap, in a normally closed position, that opens in response to a minimal pressure, wherein the flap is disposed proximally with respect to the flow restrictor;

wherein the implant is inserted in a dehydrated state in which the implant in a substantially rigid form and the implant is hydrated after insertion, providing the implant in a substantially soft and pliable form.

2. The implant of claim 1 wherein the flap is a one-way valve.

3. The implant of claim 1 wherein the flap is positioned within the head, contiguous with the opening in the head, wherein the opening of the head has a smaller cross section than the channel.

4. The implant of claim 1 further comprising a selected marking based, at least in part, on the size of the implant.

5. The implant of claim 1 further comprising a drug, wherein the body encloses the drug for controlled release.

6. The implant of claim 1 wherein the body has a star-shaped cross section.

7. The implant of claim 1 further comprising a micro-mechanical pump mounted in the body.

8. The implant of claim 1 further comprising a biocide on the flow restrictor.

9. The implant of claim 1 wherein at least one of the body, the head and the foot is constructed of at least one of an ocular hydrogel having a dehydrated state and a hydrated state, silicone, polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), hylauronic acid, a silicone/hydrogel combination, a silicone acrylic combination, fluorosilicone acrylate, ceramic, coral and stainless steel.

10. The implant of claim 9 wherein the hydrated state provides at least one of a body, head and foot dimension that is approximately 10 to approximately 50 percent larger than the dehydrated state.

11. The implant of claim 1 wherein the foot comprises a circular cross section and the body comprises a circular cross section, and

wherein a ratio between a diameter of the foot circular cross section and a diameter of the body circular cross section is defined as foot circular cross section diameter divided by body circular cross section diameter, and

wherein the ratio between a diameter of the foot circular cross section and a diameter of the body circular cross section has a value of between approximately 1.3 and approximately 3.00.

12. The implant of claim 1 wherein the flow restrictor includes a porous fiber adapted to permit fluid flow therethrough, and a cylinder surrounding the porous fiber.

13. The implant of claim 1 wherein the flow restrictor is a capillary flow restrictor.

14. The implant of claim 13 wherein the capillary flow restrictor defines capillary vessels having a sinusoidal wave shape.

15. The implant of claim 1 wherein the foot is a linear distal member.

16. An ocular shunt comprising:

a body having a distal end and a proximal end;

a head comprising a flange positioned at the proximal end of the body and defining an head opening;

a foot comprising a flange disposed at the distal end of the body and defining a foot opening;

a channel in the body communicating with head opening and the foot opening; and

a flow restrictor in the channel located at an intermediate position, disposed fully distally with respect to the head and fully proximally with respect to the foot;

wherein the implant is constructed of an ocular hydrogel having a dehydrated state and a hydrated state, and wherein the hydrated state provides at least one of a body, head and foot dimension that is approximately 10 to approximately 50 percent larger than the dehydrated state, and

wherein the flow restrictor is made of one of the group consisting of metal, titanium, ceramic and glass.

17. The shunt of claim 16 further comprising a structure adapted to control the flow of fluid through the channel, in fluid communication with the channel and responsive, at least in part, to pressure in the proximal direction to thereby permit fluid flow in the proximal direction in response to the pressure.

18. An ocular shunt comprising:

a body having a distal end and a proximal end;

a head comprising a flange positioned at the proximal end of the body and defining an head opening;

a foot comprising a flange disposed at the distal end of the body and defining a foot opening;

a channel in the body communicating with head opening and the foot opening; and

a plurality of the filters arranged in a predetermined order disposed in the channel and located at an intermediate position, disposed distally with respect to the head and proximally with respect to the foot;

wherein the implant is constructed of an ocular hydrogel having a dehydrated state and a hydrated state, and wherein the hydrated state provides at least one of a body, head and foot dimension that is approximately 10 to approximately 50 percent larger than the dehydrated state; and

a coating applied to at least one of the head, the foot, the body and the filter.

19. The shunt of claim 18 wherein the coating is a surgical adhesive applied to at least one of the head, the foot, the body.

20. The shunt of claim 18 further comprising a flap in fluid communication with the channel and selectively openable to permit fluid flow through the head opening.