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Implantable medical devices made from polymer-bioceramic composite

Inactive Publication Date: 2007-12-06
ABBOTT CARDIOVASCULAR
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0016] Certain embodiments of the present invention include a method of fabricating an implantable medical device comprising: treating the surface of a plurality of bioceramic particles with a non-reactive surface modifier; forming a composite including the treated bioceramic particles dispersed within a polymer, the non-reactive surface modifier reducing the agglomeration of the treated bioceramic particles during the formation; and fabricating an implantable medical device from the composite.
[0019] Certain other embodiments of the present invention include a method of fabricating an implantable medical device comprising: subjecting a mixture of bioceramic particles and polymer to high sheer stress using twin-screw extruder or a batch mixer; forming a composite including the bioceramic particles dispersed within a polymer, the mechanical smash, reducing the agglomeration of the bioceramic particles during the formation; and fabricating an implantable medical device from the composite.

Problems solved by technology

A potential problem with polymeric stents is that their struts or bar arms can crack during crimping and expansion.
The localized portions of the stent pattern subjected to substantial deformation during crimping and expansion tend to be the most vulnerable to failure.

Method used

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  • Implantable medical devices made from polymer-bioceramic composite
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  • Implantable medical devices made from polymer-bioceramic composite

Examples

Experimental program
Comparison scheme
Effect test

example 1

Prophetic Example of Solution Blending of Polymer and Bioceramic Particles

[0159] Step 1: Add bioceramic particles into suitable solvent, such as chloroform, acetone, etc. and stir to form a bioceramic particle suspension solution.

[0160] Step 2: Slowly add a polymer such as PLLA, PDLLA, PLGA into suspension solution and stir until polymer dissolves completely. In this step, the solution may still have a relatively low viscosity. However, the bioceramic particles should be well dispersed while stirring.

[0161] Step 3: Slowly add the polymer into solution again to gradually increase solution viscosity. Repeat this step as needed until the polymer is completely dissolved and reasonable solution viscosity is developed.

[0162] Step 4: Apply ultrasonic mixing to suspension solution for 15-30 min to further disperse all the HAP uniformly into the PLLA solution.

[0163] Step 6: Add suspension solution to methanol to precipitate polymer and particles.

example 2

[0164] Solution Blending of PLLA / HAP Composite (100:1 wt / wt)

[0165] Step 1: Added 50 mg HAP particles into 300 mL of chloroform and stirred for 10-30 minutes to form bioceramic particle suspension solution.

[0166] Step 2: Slowly added 5 g PLLA into suspension solution and stirred about 8 hours to dissolve all polymer.

[0167] Step 3: Applied ultrasonic mixing to suspension solution for 15-30 min to further disperse HAP particles into PLLA solution.

[0168] Step 4: Added suspension solution to 1 L methanol to precipitate polymer and particles.

[0169] Step 5: Filtered the precipitate and dried about 24 hours in vacuum oven at 60° C. End product is PLLA / HAP composite.

[0170] Composites were also made with 2 wt % and 5 wt % HAP.

[0171] Mechanical Properties and Morphology of PLLA / HAP Composite (100:1 wt / wt)

[0172] Tensile testing of the composite samples and a pure PLLA were performed using an Instron tensile tester obtained from Instron in Canton, Mass. Test samples were prepared by hot p...

example 3

[0174] Solution Blending of PLLA / HAP Composite (2:1 wt / wt) as HAP Intermedium Mixture

[0175] Step 1: Added 25 g HAP particles to 3 L chloroform and stirred for 10-30 minutes to form bioceramic particle suspension solution.

[0176] Step 2: Slowly added 50 g PLLA into suspension solution and stirred about 8 hours to dissolve all polymer.

[0177] Step 3: Applied ultrasonic mixing for 15-30 min to further disperse HAP particles into PLLA solution.

[0178] Step 4: Added suspension solution to 9 L methanol to precipitate particles and polymer.

[0179] Step 5: Filtered the precipitate and dried about 24 hours in vacuum oven at 60° C. End product is PLLA / HAP composite.

[0180] Extrusion of Precipitated PLLA / HAP (2:1 wt / wt) with PLLA

[0181] Step 1: Broke 2:1 wt / wt composite into small pieces

[0182] Step 2: Mixed 24 g of broken up composite and 376 g PLLA.

[0183] Step 3: Extruded mixture at 216° C.

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Abstract

Methods and devices relating to polymer-bioceramic composite implantable medical devices are disclosed.

Description

CROSS-REFERENCE [0001] This application is a continuation-in-part of U.S. application Ser. No. 11 / 706,550 filed on Feb. 14, 2007, and a continuation-in-part of U.S. application Ser. No. 11 / 529,996 filed Sep. 29, 2006, and a continuation-in-part of U.S. application Ser. No. 11 / 523,866 filed on Sep. 19, 2006, which is a continuation-in-part of U.S. application Ser. No. 11 / 443,870 filed on May 30, 2006, which are all incorporated herein by reference.BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] This invention relates to implantable medical devices and methods of fabricating implantable medical devices. [0004] 2. Description of the State of the Art [0005] This invention relates to radially expandable endoprostheses, which are adapted to be implanted in a bodily lumen. An “endoprosthesis” corresponds to an artificial device that is placed inside the body. A “lumen” refers to a cavity of a tubular organ such as a blood vessel. [0006] A stent is an example of such an ...

Claims

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Application Information

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IPC IPC(8): B29B9/08A61F2/00B29C48/05B29C48/08B29C48/09B29C48/32
CPCA61L31/127A61L31/128A61L31/148B29C47/0007Y10S977/831A61F2/82Y10S977/931Y10S977/753B29C47/0014B29C47/0021B29C47/0023Y10S977/776B29C48/05B29C48/08B29C48/09B29C48/023
Inventor WANG, YUNBINGGALE, DAVID C.
Owner ABBOTT CARDIOVASCULAR
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