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Controlled release bioactive agent delivery device

a bioactive agent and controlled release technology, applied in the field of delivery devices, can solve the problem that the device itself does not provide any other significant function, and achieve the effect of reducing the risks and disadvantages of more invasive surgical techniques, and minimizing damage and interference with body tissues

Inactive Publication Date: 2005-12-08
ANDERSON ARON B +5
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The present invention provides devices and methods for delivering bioactive agents to a treatment site in a controlled and minimally invasive manner. The invention can provide advantages such as reduced damage and interference with body tissues and processes, as well as minimizing risks and disadvantages associated with more invasive surgical techniques. The invention can be used in limited access regions of the body, such as the eye, ear, central nervous system, and the like. The invention allows for controlled release of the bioactive agent by manipulation of the device, including the formulation of the coating composition, duration of time at the implantation site, and configuration of the device. The invention can provide increased surface area for delivery of bioactive agent, as compared to a substantially linear device having the same length and width. The invention also provides mechanical advantages, such as a built-in anchoring mechanism that reduces or prevents unwanted movement of the device within the body."

Problems solved by technology

A primary function of the inventive device is to deliver the bioactive agent(s) to a desired treatment site within the body, and in preferred embodiments, the device itself does not provide any other significant function.

Method used

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  • Controlled release bioactive agent delivery device
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  • Controlled release bioactive agent delivery device

Examples

Experimental program
Comparison scheme
Effect test

example 1

Release of Triamcinolone Acetonide from Stainless Steel Wires

[0167] Three different polymer solutions were prepared in tetrahydrofuran (THF) in the manner provided below in order to provide coating compositions in the form of a one-part system. The three solutions contained varying amounts of poly(ethylene-co-vinyl acetate), with a vinyl acetate content of 33% (w / w), relative to the amount of poly(n-butyl)methacrylate, with an approximate weight average molecular weight of 337 kD. Each of the three solutions contained a constant amount of triamcinolone acetonide relative to the total polymer weight.

[0168] The coating compositions were prepared as follows. The polymers were initially added to the THF and dissolved overnight while mixing on a shaker at 200 revolutions per minute (rpm) at room temperature (approximately 20° C. to 22° C.). After dissolution of the polymer, the triamcinolone acetonide was added, and the mixture was placed back on the shaker at 100 rpm for 1 hour, to fo...

example 2

In Vitro Release of Triamcinolone Acetonide from Helical Coils

[0177] Two different solutions were prepared in tetrahydrofuran (THF) as in Example 1. The compositions prepared are summarized in Table III:

TABLE IIICoating Compositions applied to the Helical Coil.Parts by weightWeight of coatedCoatingComposition(pbw)composition (μg)Coating 1dTA / pEVA / pBMA50 / 27.5 / 22.51950Coating 1eTA / pEVA / pBMA50 / 40 / 101928

[0178] Helical coils with attached caps were fabricated from the alloy MP35N™ (commercially available from ESPI, Ashland, Oreg.). The coils were cleaned in an alkaline solution, then rinsed with deionized water. The coils underwent additional cleaning using an isopropyl alcohol wash and rinse. The coils were dried and weighed prior to coating.

[0179] Solutions for Coatings 1d and 1e were sprayed onto the coils using ultrasonic coater equipment that consisted of an ultrasonic spray head (Sono-Tek Milton, N.Y.) and syringe pump system for the coating solution. A pin vise was used to hol...

example 3

In Vivo Release of Triamcinolone Acetonide from Helical Coils

[0184] Ten coils were coated with two different formulations, Dose A and Dose B, and were implanted into the vitreous chamber of rabbit eyes to provide sustained release of triamcinolone acetonide. Table V summarizes the coating compositions applied to the coils in this Example. Dose B was designated a “fast release” coating, and this coating composition included a relatively larger ratio of pEVA to PBMA, as compared to the “slow release” Dose A coating composition.

[0185] The coating solutions were prepared according to the procedure described in Example I. The coating solutions were applied to the coils according to the procedure described in Example II. The coated coils were implanted into the vitreous chamber of rabbit eyes as follows. The conjunctiva was dissected and pulled away from the incision site, and an incision was made into the eyes utilizing a needle stick through the sclera. A self-starting coil that inclu...

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PUM

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Abstract

The invention provides methods for delivering bioactive agent to an eye, the methods including steps of providing a device at an implantation site within the eye, and maintaining the device at the implantation site to provide a therapeutically effective amount of the bioactive agent to the eye. The device includes a body member having a direction of extension, a longitudinal axis along the direction of extension, and a proximal end and a distal end, wherein at least a portion of the body member deviates from the direction of extension. A polymeric coated composition is provided in contact with a surface of the body member, the polymeric coated composition including a first polymer, a second polymer, and a bioactive agent. The invention also provides methods of administering a therapeutically effective amount of bioactive agent to a posterior segment of an eye.

Description

[0001] This application is a continuation of U.S. application Ser. No. 10 / 835,530, filed Apr. 29, 2004, entitled “CONTROLLED RELEASE BIOACTIVE AGENT DELIVERY DEVICE”, which claims the benefit of U.S. Provisional Application Ser. No. 60 / 467,419, filed May 2, 2003, entitled “CONTROLLED RELEASE BIOACTIVE AGENT DELIVERY DEVICE,” which applications are incorporated herein by reference in their entirety.FIELD OF THE INVENTION [0002] The invention relates to a delivery device for controlled delivery of one or more bioactive agents to a treatment site within the body. BACKGROUND OF THE INVENTION [0003] Many surgical interventions involve placement of a medical device into the body. While beneficial for treating a variety of medical conditions, the placement of metal or polymeric devices in the body can give rise to numerous complications. Some of these complications include increased risk of infection, initiation of a foreign body response (which can result in inflammation and / or fibrous en...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/00A61K31/58
CPCA61F2310/00353A61K9/0051A61K31/58A61P27/02
Inventor ANDERSON, ARON B.LAWIN, LAURIE R.SHEN, BYRON C.JUAN, EUGENE DEVARNER, SIGNE E.CHAPPA, RALPH A.
Owner ANDERSON ARON B
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