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Medical devices and methods of making the same

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Title: Medical devices and methods of making the same.
Abstract: Medical devices, such as endoprostheses, and related methods are disclosed. ...


Browse recent Boston Scientific Scimed, Inc. patents - Maple Grove, MN, US
Inventor: Timothy S. Girton
USPTO Applicaton #: #20120046734 - Class: 623 142 (USPTO) - 02/23/12 - Class 623 
Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor > Arterial Prosthesis (i.e., Blood Vessel) >Drug Delivery

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The Patent Description & Claims data below is from USPTO Patent Application 20120046734, Medical devices and methods of making the same.

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CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims priority under 35 U.S.C. §120 to U.S. application Ser. No. 11/855,019, filed on Sep. 13, 2007, which is a non-provisional of U.S. Provisional Application Ser. No. 60/845,046, filed on Sep. 15, 2006, the entire contents of which are hereby incorporated by reference.

TECHNICAL FIELD

The invention relates to medical devices, such as, for example, endoprostheses, and to related methods.

BACKGROUND

The body includes various passageways such as arteries, other blood vessels, and other body lumens. These passageways sometimes become occluded or weakened. For example, the passageways can be occluded by a tumor, restricted by plaque, or weakened by an aneurysm. When this occurs, a passageway can be reopened or reinforced, or even replaced, with a medical endoprosthesis. An endoprosthesis is typically a tubular member that is placed in a lumen in the body. Examples of endoprostheses include stents, stent-grafts, and covered stents.

An endoprosthesis can be delivered inside the body by a catheter that supports the endoprosthesis in a compacted or reduced-size form as the endoprosthesis is transported to a desired site. Upon reaching the site, the endoprosthesis is expanded, for example, so that it can contact the walls of the lumen.

The expansion mechanism may include forcing the endoprosthesis to expand radially. For example, the expansion mechanism can include the catheter carrying a balloon, which carries a balloon-expandable endoprosthesis. The balloon can be inflated to deform and to fix the expanded endoprosthesis at a predetermined position in contact with the lumen wall. The balloon can then be deflated, and the catheter withdrawn.

In another delivery technique, the endoprosthesis is formed of an elastic material that can be reversibly compacted and expanded (e.g., elastically or through a material phase transition). During introduction into the body, the endoprosthesis is restrained in a compacted condition. Upon reaching the desired implantation site, the restraint is removed, for example, by retracting a restraining device such as an outer sheath, enabling the endoprosthesis to self-expand by its own internal elastic restoring force.

To support a passageway and keep the passageway open, endoprostheses are sometimes made of relatively strong materials, such as stainless steel or Nitinol (a nickel-titanium alloy), formed into struts or wires.

SUMMARY

In one aspect, the invention features an endoprosthesis including a generally tubular member having a lumen and including at least one component selected from struts, bands, and combinations thereof. The component includes a bioerodible material selected from bioerodible metals, bioerodible metal alloys, and combinations thereof. The component has a first region including pores and a second region including pores, and the average maximum dimension (e.g., diameter) of the pores in the second region is greater than the average maximum dimension (e.g., diameter) of the pores in the first region.

In another aspect, the invention features an endoprosthesis including a generally tubular member having a lumen and including at least one component selected from struts, bands, and combinations thereof. The component includes a bioerodible material selected from bioerodible metals, bioerodible metal alloys, and combinations thereof. The component has a first region and a second region having a higher pore density than the first region.

In an additional aspect, the invention features an endoprosthesis including a generally tubular member having a lumen. The generally tubular member includes at least one component selected from struts, bands, and combinations thereof. The component includes a bioerodible material selected from bioerodible metals, bioerodible metal alloys, and combinations thereof. The component has at least one pore, and the endoprosthesis includes a polymer that is disposed within the pore.

In a further aspect, the invention features an endoprosthesis including a generally tubular member having a first region including pores and a second region including pores. The first region defines an interior surface of the generally tubular member, and the second region defines an exterior surface of the generally tubular member. The average maximum dimension of the pores in the second region is greater than the average maximum dimension of the pores in the first region. The generally tubular member includes a bioerodible material selected from bioerodible metals, bioerodible metal alloys, and combinations thereof.

In another aspect, the invention features an endoprosthesis including a generally tubular member. The generally tubular member has a first region defining an interior surface of the generally tubular member and a second region defining an exterior surface of the generally tubular member. The second region has a higher pore density than the first region. The generally tubular member includes a bioerodible material selected from bioerodible metals, bioerodible metal alloys, and combinations thereof.

In an additional aspect, the invention features an endoprosthesis including a generally tubular member and a polymer. The generally tubular member has at least one pore, and the polymer is disposed within the pore. The generally tubular member includes a bioerodible material selected from bioerodible metals, bioerodible metal alloys, and combinations thereof.

In a further aspect, the invention features a method including delivering an endoprosthesis into a lumen of a subject. The endoprosthesis includes a generally tubular member including a therapeutic agent and a bioerodible material selected from bioerodible metals, bioerodible metal alloys, and combinations thereof. The generally tubular member erodes at an erosion rate and the therapeutic agent elutes into the lumen of the subject at an elution rate. The elution rate is slower than the erosion rate.

In another aspect, the invention features an endoprosthesis including a generally tubular member having a lumen. The generally tubular member includes at least one component selected from struts, bands, and combinations thereof. The component includes a reservoir surrounded by a matrix including a bioerodible material and having at least one pore. The bioerodible material is selected from bioerodible metals, bioerodible metal alloys, and combinations thereof.

Embodiments can include one or more of the following features.

The first and/or second region of the component and/or the generally tubular member can include at least one pore (e.g., multiple pores). The average maximum dimension of the pores in the second region can be different from (e.g., greater than) the average maximum dimension of the pores in the first region. In some embodiments, the average maximum dimension of the pores in the second region can be at least about 1.5 times greater (e.g., at least about two times greater, at least about five times greater, at least about 10 times greater) than the average maximum dimension of the pores in the first region.

The endoprosthesis can include a therapeutic agent. The reservoir can contain a therapeutic agent. The endoprosthesis can include a polymer (e.g., a bioerodible polymer). The polymer can be supported by the component and/or the generally tubular member. The polymer can be disposed within pores of the component and/or the generally tubular member. In some embodiments, the polymer can be disposed within at least one pore (e.g., multiple pores) in the first region and/or the second region of the component and/or the generally tubular member. In certain embodiments, the endoprosthesis can include a composite including a therapeutic agent and a polymer.

The generally tubular member can have an exterior surface and an interior surface that defines the lumen of the generally tubular member. In some embodiments, the first region of the component can define at least a portion of the interior surface of the generally tubular member. In certain embodiments, the second region of the component can define at least a portion of the exterior surface of the generally tubular member.

The pore density of the second region of the component and/or the generally tubular member can be different from (e.g., higher than) the pore density of the first region of the component and/or the generally tubular member. In some embodiments, the pore density of the second region can be at least about 1.5 times higher (e.g., at least about two times higher, at least about five times higher, at least about 10 times higher) than the pore density of the first region.

In certain embodiments, the first and/or second regions of the component and/or the generally tubular member may not include any pores.

Embodiments can include one or more of the following advantages.



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Industry Class:
Prosthesis (i.e., artificial body members), parts thereof, or aids and accessories therefor
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stats Patent Info
Application #
US 20120046734 A1
Publish Date
02/23/2012
Document #
13284467
File Date
10/28/2011
USPTO Class
623/142
Other USPTO Classes
623/139
International Class
61F2/82
Drawings
19



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