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Medical devices having nanoporous bonding layers

a technology of nanoporous bonding and medical devices, which is applied in the direction of prosthesis, drug compositions, peptides, etc., can solve the problems of porous alumina with porous alumina has severe mechanical integrity problems, and polymer coatings, etc., to reduce the risk of delamination

Inactive Publication Date: 2006-08-31
UNIV OF VIRGINIA ALUMNI PATENTS FOUND +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent text describes a method for modifying medical devices, such as coronary stents, to carry and release therapeutic agents. The method involves creating a layer of porous metal on the surface of the device using a process called dealloying. This layer can be used to adhere to a drug-carrying polymer coating or can be loaded with therapeutic agents to achieve controlled release. The method allows for the adjustment of pore size and thickness to control elution kinetics. The invention also includes the use of nanoporous metallic surfaces and the ability to load therapeutic agents into the porous layer. The stent can also have a therapeutic agent within the porous layer. The technical effects of this invention include improved adhesion and mechanical properties of the therapeutic agent-modified medical devices.

Problems solved by technology

Polymer coatings, for example, have limitations related to coating adhesion, mechanical properties, inflammatory properties, and material biocompatibility, while porous alumina has severe issues with regard to mechanical integrity.

Method used

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  • Medical devices having nanoporous bonding layers
  • Medical devices having nanoporous bonding layers
  • Medical devices having nanoporous bonding layers

Examples

Experimental program
Comparison scheme
Effect test

example b

2. Example B

[0205] In another specific example, a coronary stent is co-sputtered with L605 (1.5 A / s) and magnesium (12 A / s) in 2×10-3 torr Argon for a resulting alloy coating that is approximately 80% by weight of magnesium. The stent is dealloyed using a 1% HNO3 at about 1° Celsius for about 5 minutes, followed by an anneal at about 600° Celsius for 10 minutes at about 10−5 torr vacuum with a ramp rate of about 200° Celsius / minute. This process produces a dealloyed layer as depicted in the scanning electron micrograph in FIG. 19. The resulting porous zone is approximately 5% by weight of magnesium and has a range of pore sizes from about 10 nm to about 200 nm. In a further embodiment, this stent is loaded with rapamycin using the same procedure as disclosed in Example A, resulting in an initial payload of about 85 micrograms. Place in an in vivo porcine coronary artery stent model results in a 7 day tissue concentration of about 0.80 ng / mg of tissue as measured by tandem MS / MS HPLC...

example c

3. Example C

[0206] In still another specific example, a coronary stent undergoes a lower layer sputter deposition with L605 (1.5 A / s) and magnesium (12 A / s) in 2×10-3 torr Argon, and followed by an additional upper layer co-sputtering with L605 (3.1 A / s) and Mg (9.7 A / s) in 2×10-3 torr Argon, for a resulting alloy coating has a lower layer thickness of about 750 nm and an upper layer with a thickness of about 75 nm. Optionally, one or both sputtering steps may be repeated one or more times, in an alternating or other desired order, to create a layered columnar porous zone. In one embodiment, shown in FIG. 20, an additional two high magnesium content layers, with one lower magnesium content layer is sputtered to produce a five layer porous stent surface. The stent is dealloyed using a 1% HNO3 at about 1° Celsius for about 5 minutes, followed by an anneal at about 600° Celsius for 10 minutes at about 10−5 torr vacuum with a ramp rate of about 200° Celsius / minute. The resulting porous ...

example d

4. Example D

[0208] In still example, a coronary stent undergoes a lower layer sputter deposition with L605 (3.1 A / s) and magnesium (9.7 A / s) in 2×10-3 torr Argon, for a resulting alloy coating with about 30% magnesium content by weight. The stent undergoes thermal dealloying by heating the porous zone with a heat source at about 600° Celsius for 10 minutes at about 10−5 torr vacuum with a ramp rate of about 200° Celsius / minute. The resulting porous zone is about 10-15% by weight of magnesium with a pore size range of about 1 nm to about 25 nm, but with occasional larger spaces up to about 500 nm or more, as depicted in FIGS. 21A and 21B. Although not wishing to be bound by the theory, it is hypothesized that the different macroscopic morphologies as illustrated in FIGS. 21A and 21B may result from different intrinsic film strains prior to the thermal dealloy process. In one further embodiment, the stent is loaded with rapamycin using an alternative loading procedure as described in ...

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Abstract

The present invention relates generally to medical devices with therapy eluting components and methods for making same. More specifically, the invention relates to implantable medical devices having at least one porous layer, and methods for making such devices, and loading such devices with therapeutic agents. A mixture or alloy is placed on the surface of a medical device, then one component of the mixture or alloy is generally removed without generally removing the other components of the mixture or alloy. In some embodiments, a porous layer is adapted for bonding non-metallic coating, including drug eluting polymeric coatings. A porous layer may have a random pore structure or an oriented or directional grain porous structure. One embodiment of the invention relates to medical devices, including vascular stents, having at least one porous layer adapted to resist stenosis or cellular proliferation without requiring elution of therapeutic agents. The invention also includes methods, devices, and specifications for loading of drugs and other therapeutic agents into nanoporous coatings.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application is a continuation of U.S. application Ser. No. 11 / 200,655 filed Aug. 10, 2005, which 1) claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 60 / 602,542 filed on Aug. 18, 2004, U.S. Provisional Application No. 60 / 613,165 filed on Sep. 24, 2004, U.S. Provisional Application No. 60 / 664,376 filed on Mar. 23, 2005, and U.S. Provisional Application Ser. No. 60 / 699,302 filed Jul. 14, 2005, and 2) is a continuation-in-part of U.S. application Ser. No. 10 / 918,853 filed on Aug. 13, 2004, which is a continuation-in-part of U.S. application Ser. No. 10 / 713,244 filed on Nov. 13, 2003, which claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 60 / 426,106 filed on Nov. 13, 2002, the disclosures of which are incorporated by reference herein in their entirety.BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates generally to medical devices ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K48/00A61K38/13A61F2/06A61K31/715A61K31/727
CPCA61F2/07A61F2/91A61F2/915A61F2002/91541A61F2250/0067A61L31/022A61F2210/0076A61L31/146A61L31/16A61L31/18A61L2300/606A61L2400/12A61N1/05A61L31/10
Inventor OWENS, GARY K.WAMHOFF, BRIAN R.HUDSON, MATTHEW S.LYE, WHYE-KEISPRADLIN, JOSHUALOOI, KAREEN
Owner UNIV OF VIRGINIA ALUMNI PATENTS FOUND
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