Biodegradable controlled release bioactive agent delivery device
First Claim
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1. A sustained release implant configured to reside in a posterior segment of an eye, the implant comprising one or more bioactive agents and a biodegradable polymeric material in a solid form, wherein the implant is configured to provide sustained release of the bioactive agent into the posterior segment of the eye, and wherein the biodegradable polymeric material comprises a random block copolymer having a formula:
- wherein R1 is —
CH═
CH—
or (—
CH2—
)j, in which j is zero or an integer from one to eight;
R2 is selected from straight and branched alkyl and alkylaryl groups containing up to 18 carbon atoms and optionally containing at least one ether linkage, and derivatives of biologically and pharmaceutically active compounds covalently bonded to the copolymer;
each R3 is independently selected from alkylene groups containing 1 to 4 carbon atoms;
y is between 5 and about 3000; and
f is the percent molar fraction of alkylene oxide in the copolymer, and is in the range of about 1 to about 99 mole percent.
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Abstract
The invention provides implantable medical devices that are fabricated, at least in part, from biodegradable polymeric material. The implantable medical devices are used to provide bioactive agent to a treatment site, and are particularly useful for treatment of limited access regions of the body.
176 Citations
39 Claims
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1. A sustained release implant configured to reside in a posterior segment of an eye, the implant comprising one or more bioactive agents and a biodegradable polymeric material in a solid form, wherein the implant is configured to provide sustained release of the bioactive agent into the posterior segment of the eye, and wherein the biodegradable polymeric material comprises a random block copolymer having a formula:
-
wherein R1 is —
CH═
CH—
or (—
CH2—
)j, in which j is zero or an integer from one to eight;
R2 is selected from straight and branched alkyl and alkylaryl groups containing up to 18 carbon atoms and optionally containing at least one ether linkage, and derivatives of biologically and pharmaceutically active compounds covalently bonded to the copolymer;
each R3 is independently selected from alkylene groups containing 1 to 4 carbon atoms;
y is between 5 and about 3000; and
f is the percent molar fraction of alkylene oxide in the copolymer, and is in the range of about 1 to about 99 mole percent. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31)
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32. A method of making a device for controlled release of bioactive agent to a posterior segment of an eye, the method comprising steps of:
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(a) providing a biodegradable polymer comprising a random block copolymer having a formula;
wherein R1 is —
CH═
CH—
or (—
CH2—
)j, in which j is zero or an integer from one to eight;
R2 is selected from straight and branched alkyl and alkylaryl groups containing up to 18 carbon atoms and optionally containing at least one ether linkage, and derivatives of biologically and pharmaceutically active compounds covalently bonded to the copolymer;
each R3 is independently selected from alkylene groups containing 1 to 4 carbon atoms;
y is between 5 and about 3000; and
f is the percent molar fraction of alkylene oxide in the copolymer, and is in the range of about 1 to about 99 mole percent;
(b) combining the random block copolymer with one or more bioactive agents; and
(c) forming at least a portion of a solid implant from the random block copolymer with bioactive agent, wherein the solid implant is configured for placement in ocular tissues within the posterior segment of the eye. - View Dependent Claims (33, 34, 35, 36, 37, 38)
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39. A method for delivery of bioactive agent to ocular tissue within a patient in a controlled manner, the method comprising steps of providing an implant in a posterior segment of the patient'"'"'s eye, the implant comprising one or more bioactive agents and a biodegradable polymeric material in a solid form, wherein the implant is configured to provide sustained release of the bioactive agent into the posterior segment of the eye, and wherein the biodegradable polymeric material comprises a random block copolymer having a formula:
-
wherein R1 is —
CH═
CH—
or (—
CH2—
)j, in which j is zero or an integer from one to eight;
R2 is selected from straight and branched alkyl and alkylaryl groups containing up to 18 carbon atoms and optionally containing at least one ether linkage, and derivatives of biologically and pharmaceutically active compounds covalently bonded to the copolymer;
each R3 is independently selected from alkylene groups containing 1 to 4 carbon atoms;
y is between 5 and about 3000; and
f is the percent molar fraction of alkylene oxide in the copolymer, and is in the range of about 1 to about 99 mole percent.
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Specification