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Apparatus and methods for controlled substance delivery from implanted prostheses

a controlled substance and implanted prosthesis technology, applied in the field of medical devices and methods, can solve the problems of frequent occurrence of restenosis, no one of these procedures is proven to be completely successful in substantially or completely avoiding all occurrences of restenosis and hyperplasia, and continue to suffer significant disadvantages. , to achieve the effect of reducing the formation or progression of restenosis and/or hyperplasia

Inactive Publication Date: 2005-05-19
ALTAI MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0015] The present invention is directed to improved devices for preparation or treatment of susceptible tissue sites, and methods making and using the same. In particular, the present invention is directed to corporeal, more particularly intracorporeal devices. In one embodiment, the present devices and methods reduce the formation or progression of restenosis and / or hyperplasia which may follow an intravascular intervention. In an embodiment, the device provides a therapeutic capable agent to the susceptible tissue site. Preferably, the therapeutic capable agent is provided to the therapeutic capable agent in a manner as to become available, immediately or after a delay period, to the susceptible tissue site upon introduction of the device to the corporeal body.

Problems solved by technology

While these procedures have gained wide acceptance (either alone or in combination, particularly PTA in combination with stenting), they continue to suffer from significant disadvantages.
A particularly common disadvantage with PTA and other known procedures for opening stenotic regions is the frequent occurrence of restenosis.
While these proposals have enjoyed varying levels of success, no one of these procedures is proven to be entirely successful in substantially or completely avoiding all occurrences of restenosis and hyperplasia.
While holding great promise, the delivery of therapeutic agents for the inhibition of restenosis has not been entirely successful.
While holding great promise, the delivery of therapeutic agents for the inhibition of restenosis has not been entirely successful.

Method used

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  • Apparatus and methods for controlled substance delivery from implanted prostheses
  • Apparatus and methods for controlled substance delivery from implanted prostheses
  • Apparatus and methods for controlled substance delivery from implanted prostheses

Examples

Experimental program
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Effect test

example 1

[0190] A stainless steel Duraflex™ stent, having dimensions of approximately 3.0 mm×14 mm was sprayed with a solution of 25 mg / ml therapeutic capable agent in a 100% ethanol or methanol solvent. The stent was dried and the ethanol was evaporated leaving the therapeutic capable agent on the stent surface. A 75:25 PLLA / PCL copolymer (sold commercially by Polysciences) was prepared in 1,4 Dioxane (sold commercially by Aldrich Chemicals). The therapeutic capable agent coated stent was loaded on a mandrel rotating at 200 rpm and a spray gun (sold commercially by Binks Manufacturing) used to dispense the copolymer solution in a fine spray onto the coated stent, as the stent rotated for approximately a 10-30 second time period. The stent was then placed in an oven at 25-35° C. for up to 24 hours to complete the evaporation of the solvent.

example 2

[0191] A stainless steel Duraflex stent (3.0×18 mm) was laser cut from a SS tube. The surface area of the stent for receiving the therapeutic capable agent was increased by increasing the surface roughness of the stent. The surface area and the volume of the stent can be further increased by creating 10 nm wide by 5 nm deep grooves along the links of the stent strut. The grooves were created in those stent areas experiencing low stress during expansion so as not to compromise the stent radial strength. The drug was loaded onto the stent and in the stent grooves by dipping or spraying the stent in the therapeutic capable agent solution prepared in low surface tension solvent such as isopropyl alcohol, ethanol, or methanol. The stent was then dried with the therapeutic capable agent remaining on the stent surface, and in the grooves which served as a reservoir for the therapeutic capable agent. Parylene was then vacuum deposited on the stent to serve as a rate-controlling barrier. The...

example 3

[0192] A therapeutic capable agent was dissolved in methanol, then sprayed onto the stent. The stent was left to dry with the solvent evaporating from the stent leaving the therapeutic capable agent on the stent. A matrix or barrier (silicone, polyurethane, polytetrafluorethylene, parylast, parylene) was sprayed or deposited on the stent covering the therapeutic capable agent. The amount of therapeutic capable agent varied from about 100 micrograms to 2 milligrams, with release rates from 1 day to 45 days.

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Abstract

The present invention provides improved stents and other prostheses for delivering substances to vascular and other luminal and intracorporeal environments. In particular, the present invention provides luminal prostheses which allow for a programmed and controlled substance delivery protocols for a variety of purposes. The prostheses comprise a scaffold which is implantable within a body lumen and a substance reservoir present over at least a portion of the scaffold. Usually, a rate-controlling element will be formed over the substance-containing reservoir to provide for a number of different substance release characteristics.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. patent application Ser. No. 10 / 017,500, filed on Dec. 14, 2001, which is a continuation-in-part of U.S. patent application Ser. No. 10 / 002,595, filed Nov. 1, 2001, which claims the benefit of Provisional U.S. Patent Application 60 / 258,024, filed on Dec. 22, 2000; and which is a continuation-in-part of U.S. patent application Ser. Nos. 09 / 783,253, 09 / 782,927 (now U.S. Pat. No. 6,471,980), Ser. Nos. 09 / 783,254, and 09 / 782,804, all filed on Feb. 13, 2001; and which claims the benefit of Provisional U.S. Patent Application 60 / 308,381, filed on Jul. 26, 2001. Each of these applications is assigned to the assignee of the present application. The full disclosures of each of the above applications is incorporated herein by reference.BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates generally to medical devices and methods. More particularly, the present ...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61F2/00A61F2/06A61F2/82A61F2/84A61F2/90A61L27/54A61L31/00A61L31/16
CPCA61F2/91A61F2/915A61F2/95A61F2002/91533A61F2002/91558A61F2002/91583A61F2230/0054A61F2250/0068A61L27/54A61L31/16A61L2300/416A61L2300/602A61F2250/0067
Inventor SIRHAN, MOTASIMYAN, JOHN
Owner ALTAI MEDICAL TECH
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