MANUFACTURING METHOD FOR SHAPE MEMORY POLYMER INTRAOCULAR DEVICES
A shape memory polymer (SMP) intraocular lens may have a refractive index above 1.45, a Tg between 10° C. and 60° C., inclusive, de minimis or an absence of glistening, and substantially 100% transmissivity of light in the visible spectrum. The intraocular lens is then rolled at a temperature above Tg of the SMP material. The intraocular device is radially compressed within a die to a diameter of less than or equal to 1.8 mm while maintaining the temperature above Tg. The compressed intraocular lens device may be inserted through an incision less than 2 mm wide in a cornea or sclera or other anatomical structure. The lens can be inserted into the capsular bag, the ciliary sulcus, or other cavity through the incision. The SMP can substantially achieve refractive index values of greater than or equal to 1.45.
1 . A method of manufacturing an intraocular device comprising
providing a shape memory polymer (SMP) material with a Tg;
forming the SMP material in a permanent intraocular device form;
mechanically compressing the intraocular device at a temperature above Tg to deform the intraocular device into a smaller volume; and
cooling the deformed intraocular device while still in compression to a temperature below Tg to thereby create a stable deformed intraocular device with a delivery profile allowing for insertion through an incision of 2 mm or less.
2 . The method of claim 1 , wherein the forming operation further comprises cast molding the SMP material into the permanent intraocular device form.
3 . The method of claim 2 further comprising oversizing a mold by 0.1-20% of a desired final size of the permanent intraocular device form to account for volume shrinkage that may occur during a polymerization process of the SMP material in the cast molding operation.
4 . The method of claim 1 wherein the forming operation further comprises liquid injection molding the SMP material into the permanent intraocular device form.
5 . The method of claim 4 further comprising utilizing ultra-high pressures during the liquid injection molding operation to minimize volume shrinkage during polymerization.
6 . The method of claim 1 , wherein the forming operation further comprises cryolathing the SMP material into the permanent intraocular device form.
7 . The method of claim 1 , wherein the delivery profile of the deformed intraocular device is configured to fit within an incision less than or equal to 1.8 mm wide.
8 . The method of claim 1 further comprising
rolling the intraocular device at a temperature above Tg of the SMP material;
cooling the rolled intraocular device while still in a rolled form to a temperature below Tg to thereby create a stable rolled intraocular device; and
mechanically compressing the intraocular device to a diameter of less than or equal to 1.8 mm.
9 . The method of claim 1 further comprising
rolling the intraocular device at a temperature above Tg of the SMP material; and
radially compressing the intraocular device within a die to a diameter of less than or equal to 1.8 mm while maintaining the temperature above Tg.
10 . The method of claim 1 further comprising packaging the deformed intraocular device for storage at or above room temperature.
11 . The method of claim 1 , wherein the intraocular device is an intraocular lens.
12 . The method of claim 1 , wherein the intraocular device is an intracorneal implant.
13 . The method of claim 1 , wherein the SMP material comprises a tert-butyl acrylate (tBA) monomer and a bisphenol A propoxylate diacrylate (BPA-P) diacrylate cross-inking polymer.
14 . The method of claim 1 , wherein the SMP material comprises a tert-butyl acrylate (tBA) monomer and a poly(ethylene glycol) dimethacrylate cross-inking polymer with a molecular weight substantially between 500 and 2000, inclusive, and with a crosslinking percentage substantially between 10 wt % to 50 wt %, inclusive.
15 . The method of claim 1 , wherein the SMP material comprises a tert-butyl acrylate (tBA) monomer and poly(ethylene glycol) diacrylate crosslinking polymer with a molecular weight substantially between 500 and 2000, inclusive, and with a crosslinking percentage substantially between 10 wt % to 50 wt %, inclusive.
16 . The method of claim 1 , wherein the SMP material comprises a tert-butyl acrylate monomer, an isobutyl acrylate monomer, a butyl acrylate monomer, and a poly(ethylene glycol) dimethacrylate and/or a poly(ethylene glycol) diacrylate cross-linking monomer with a molecular weight substantially between 500 and 2000, inclusive.
17 . The method of claim 16 , wherein the Tg of the SMP material is between 10 C and 60 C.
18 . The method of claim 1 , wherein the Tg of the SMP material is greater than or equal to human body temperature.
19 . The method of claim 1 , wherein the intraocular device once implanted and reformed exhibits greater than 98 percent shape recovery from the deformed intraocular device to upon reaction to an external stimulus.
20 . The method of claim 19 wherein the external stimulus is heat above Tg.
21 . The method of claim 20 , wherein Tg is substantially equal to 37° C.
22 . The method of claim 19 , wherein the external stimulus is ultraviolet radiation.
23 . The method of claim 19 , wherein the reaction to the external stimulus is delayed for up to 600 seconds.
24 . The method of claim 19 , wherein the reaction initiates within 3 to 25 seconds.
25 . The method of claim 1 , wherein the SMP material comprises a color additive.
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