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11/24/05 - USPTO Class 623 |  119 views | #20050261760 | Prev - Next | About this Page  623 rss/xml feed  monitor keywords

Medical devices and methods of making the same

USPTO Application #: 20050261760
Title: Medical devices and methods of making the same
Abstract: Medical devices, such as endoprostheses, and methods of making the devices are described. In some embodiments, the invention features a medical device including a generally tubular body including a biodisintegrable material, and a polyelectrolyte on the generally tubular body. The polyelectrolyte can be used to delay and/or slow the disintegration of the biodisintegrable material. (end of abstract)



Agent: Fish & Richardson PC - Minneapolis, MN, US
Inventor: Jan Weber
USPTO Applicaton #: 20050261760 - Class: 623001380 (USPTO)

Related Patent Categories: Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor, Arterial Prosthesis (i.e., Blood Vessel), Absorbable In Natural Tissue

Medical devices and methods of making the same description/claims


The Patent Description & Claims data below is from USPTO Patent Application 20050261760, Medical devices and methods of making the same.

Brief Patent Description - Full Patent Description - Patent Application Claims
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CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation-in-part of, and claims priority under 35 U.S.C. .sctn. 120 to, U.S. patent application Ser. No. 10/985,242, filed on Nov. 10, 2004, and entitled "Medical Devices and Methods of Making the Same", and U.S. patent application Ser. No. 10/849,742, filed on May 20, 2004, and entitled "Medical Devices Having Multiple Layers", both of which are incorporated herein by reference in their entirety.

TECHNICAL FIELD

[0002] The invention relates to medical devices, such as, for example, endoprostheses, and methods of making the devices.

BACKGROUND

[0003] 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, the 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.

[0004] 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.

[0005] 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.

[0006] 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.

[0007] 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

[0008] In one aspect, the invention features medical devices (e.g., endoprostheses) that include one or more biodisintegrable materials, and methods of making the devices. The medical devices may include at least one region that is formed of one or more biodisintegrable materials, or may be formed entirely of one or more biodisintegrable materials. The disintegration of the biodisintegrable materials in the medical devices can be controlled. For example, in some embodiments, the medical devices can include one or more polyelectrolytes, which can be used to control the disintegration of the biodisintegrable materials. In certain embodiments, the polyelectrolytes can be in the form of layers. The layers can, for example, limit or prevent water molecules and/or certain ions (e.g., in body fluid) from contacting the biodisintegrable materials, thereby delaying and/or slowing the disintegration of the biodisintegrable materials. In some embodiments, the layers can limit the movement of the water molecules and/or ions, and/or can slow the rate at which the water molecules and/or ions access and contact the biodisintegrable materials.

[0009] In another aspect, the invention features a medical device including a generally tubular body that includes a biodisintegrable material, and a first polyelectrolyte on the generally tubular body.

[0010] In an additional aspect, the invention features a medical device that includes a substrate including a biodisintegrable material and a layer supported by the substrate, the layer including one or more charges.

[0011] In a further aspect, the invention features a method of making a medical device, the method including forming a first layer on a generally tubular body including a biodisintegrable material. The first layer includes a polyelectrolyte.

[0012] In another aspect, the invention features a method of making a medical device, the method including forming a layer on a substrate including a biodisintegrable material. The layer includes one or more charges.

[0013] In a further aspect, the invention features a medical device including a generally tubular body that includes a biostable material, and a polyelectrolyte on the generally tubular body. In some embodiments, the medical device can further include a non-polyelectrolyte biodisintegrable coating.

[0014] In an additional aspect, the invention features a medical device including a generally tubular body that includes a biodisintegrable material, a polyelectrolyte on the generally tubular body, and a non-polyelectrolyte biodisintegrable coating.

[0015] Embodiments may include one or more of the following features.

[0016] The polyelectrolyte can be biodisintegrable.

[0017] In some embodiments, the polyelectrolyte can be a polyacid, such as a polyphosphoric acid, a polyvinylsulfuric acid, a polyvinylsulfonic acid, a polyvinylphosphonic acid, or a polyacrylic acid. In certain embodiments, the polyelectrolyte can be a polybase, such as polyallylamine, polyethylimine, polyvinylamine, or polyvinylpyridine.

[0018] In some embodiments, the polyelectrolyte can be a polycation, such as a poly(allylamine)polycation, a polyethyleneimine polycation, a polydiallyldimethylammonium polycation, a protamine sulfate polycation, a chitosan polycation, a gelatin polycation, a spermidine polycation, a poly(N-octyl-4-vinyl pyridinium iodide) polycation, or an albumin polycation. In certain embodiments, the polyelectrolyte can be a polyanion, such as a poly(styrene sulfonate)polyanion, a polyacrylic acid polyanion, a sodium alginate polyanion, a polystyrene sulfonate polyanion, a eudragit polyanion, a gelatin polyanion, a hyaluronic acid polyanion, a carrageenan polyanion, a chondroitin sulfate polyanion, or a carboxymethylcellulose polyanion.

[0019] The polyelectrolyte can include a polymer, such as heparin, a protein, polyglycolic acid, polylactic acid, a polyamide, poly-2-hydroxy-butyrate, polycaprolactone, or poly(lactic-co-glycolic)aci- d.

[0020] The layer can include a polyelectrolyte. The layer can be biodisintegrable or biostable.

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