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Preparation of medical devices by solid free-form fabrication methods

Assignee: Massachusetts Institute of Technology
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Filing: 1993-10-18
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Granted: 1996-02-13
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Expires: 2013-10-18
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Abstract

Abstract Solid free-form techniques for making medical devices for controlled release of bioactive agent and implantation and growth of Cells are described using computer aided design. Examples of SFF methods include stereo-lithography (SLA), selective laser sintering (SLS), ballistic particle manufacturing (BPM), fusion deposition modeling (FDM), and three dimensional printing (3DP). The macrostructure and porosity of the device can be manipulated by controlling printing parameters. Most importantly, these features can be designed and tailored using computer assisted design (CAD) for individual patients to optimize therapy.

Inventors

  • 👤 Linda G. Cima
  • 👤 Michael J. Cima

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 01:58
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/022; A61F2/10; A61F2/105; A61F2/28; A61K; A61K9/00; A61K9/0012; A61K9/0019; A61K9/0024; A61K9/0087; A61K9/0097; A61K9/14; A61K9/16; A61K9/1605; A61K9/1629; A61K9/1641; A61K9/1647; A61K9/1682; A61K9/1694; A61L; A61L27/00; A61L27/28; A61L27/34; A61L27/36; A61L27/38; A61L27/3804; A61L27/3808; A61L27/40; A61L27/50; A61L27/56; A61L27/60; B; B29; B29C; B29C64/00; B29C64/10; B29C64/165; B33; B33Y; B33Y10/00; B33Y70/00; B33Y70/10; B33Y80/00; A61F2/30; A61F2/30756; A61F2/3094; A61F2/0077; A61F2002/0086; A61F2002/009; A61F2002/30001; A61F2002/30003; A61F2002/30004; A61F2002/30011; A61F2002/30032; A61F2002/3006; A61F2002/30062; A61F2002/30108; A61F2002/30199; A61F2002/3028; A61F2002/30667; A61F2002/30677; A61F2/30767; A61F2002/3093; A61F2002/30932; A61F2/30942; A61F2002/30962; A61F2210/00; A61F2210/0004; A61F2230/00; A61F2230/0063; A61F2240/00; A61F2240/001; A61F2250/00; A61F2250/0014; A61F2250/0023; A61F2250/003; A61F2250/0031; A61F2250/0058; A61F2250/0067; A61F2310/00; A61F2310/00005; A61F2310/00359; B29K; B29K2995/00; B29K2995/0037; B29K2995/0063; B29K2995/0064; Y; Y10; Y10S; Y10S623/00; Y10S623/901; Y10T; Y10T428/00; Y10T428/249921; Y10T428/249953; Y10T428/249954; Y10T428/249961; Y10T428/249978; Y10T428/249986; Y10T428/249994; Y10T428/249999

Claims Analysis

Total Claims: 20
Claim 1
Independent Claim 41 words
A method for making medical devices comprising forming an implantable medical device using a solid free-form fabrication method to form a matrix of sequential layers of biocompatible material, wherein the matrix has a defined microstructure on a scale of ten microns.
Claim 2
Independent Claim 41 words
A method for making medical devices comprising forming an implantable medical device using a solid free-form fabrication method to form a matrix of sequential layers of biocompatible material, wherein the matrix has a defined microstructure on a scale of ten microns.
Claim 3
Dependent Claim 31 words
The method of claim 1 wherein the method is ballistic particle manufacturing or fusion deposition modeling and polymeric material is applied to a platform in layers to form a polymeric device.
Claim 4
Dependent Claim 47 words
The method of claim 1 wherein the method is three dimensional printing, comprising preparing a dispersion of particles formed of a biocompatible polymer on a platform; and applying a binder for the polymeric particle to the dispersion of polymer particles to form a pattern of solidified polymer.
Claim 5
Dependent Claim 30 words
The method of claim 1 wherein the method is selective laser sintering comprising applying polymeric particles to a platform and fusing selected area of the polymeric particles with a laser.
Claim 6
Dependent Claim 22 words
The method of claim 1 wherein the method is stero-lithography comprising photopolymerizing selected areas of a bath of photopolymerizable prepolymer or monomers.
Claim 7
Dependent Claim 15 words
The method of claim 1 further comprising adding to the biocompatible material a bioactive agent.
Claim 8
Dependent Claim 21 words
The method of claim 6 wherein the bioactive agent is added to the biocompatible particles used to form the matrix layers.
Claim 9
Dependent Claim 25 words
The method of claim 6 wherein the bioactive agent is added to a solvent or binder for biocompatible particles used to form the matrix layers.
Claim 10
Dependent Claim 36 words
The method of claim 8 wherein the solvent for the bioactive agent is not a solvent for the biocompatible material, wherein three dimensional printing is used to form discrete regions of bioactive agent within a matrix.
Claim 11
Dependent Claim 41 words
The method of claim 6 wherein the bioactive agent is added to the biocompatible particles in a solvent for the particles and the bioactive agent is applied to the particles at the same time as the particles are dissolved and resolidified.
Claim 12
Dependent Claim 18 words
The method of claim 3 wherein the particles have a diameter of between approximately one and ten microns.
Claim 13
Dependent Claim 13 words
The method of claim 1 wherein the biocompatible material is a biodegradable polymer.
Claim 14
Dependent Claim 28 words
The method of claim 6 wherein the biocompatible material is a non-degradable polymer and forms a porous matrix through which bioactive agent can diffuse out of the device.
Claim 15
Dependent Claim 17 words
The method of claim 6 wherein the bioactive agent is present in the device in different concentrations.
Claim 16
Dependent Claim 13 words
The method of claim 14 wherein the bioactive agent forms a concentration gradient.
Claim 17
Dependent Claim 21 words
The method of claim 6 wherein the bioactive agent is incorporated into the device so as to result in pulsed release.
Claim 18
Dependent Claim 23 words
The method of claim 1 further comprising creating porous spaces within the device matrix which allow ingrowth of tissue within the porous spaces.
Claim 19
Dependent Claim 75 words
The method of claim 1 further comprising forming features in the matrix selected from the group consisting of structural elements that degrade more slowly than the other material forming the matrix and thereby provide structural support to the matrix, bioactive materials, variable composition of material forming the matrix or of bioactive materials incorporated into the matrix, regions of materials having different rates of biodegradability, and bimodal pore size distribution and directionally oriented pores and channels.
Claim 20
Dependent Claim 17 words
The method of claim 3 wherein the matrix is formed from polymer particles suspended in a non-solvent.

References Cited (Backward Citations)

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USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1999-02-12 1999-08-14 2000-02-13 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2003-02-12 2003-08-14 2004-02-13 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2007-02-12 2007-08-14 2008-02-13 $7700.00 Window Closed / Lapsed

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