Methods of making a porous device

• US 5,605,693 A
• Filed: 06/07/1995
• Issued: 02/25/1997
• Est. Priority Date: 10/18/1991
• Status: Expired due to Term

• Current Assignee: SM Technologies LLC
• Original Assignee: William J. Seare Jr
• Inventors: Seare, William J. Jr.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Benston, Jr., William E.
• Application Number:
  US08/475,210
• Time in Patent Office: 629 Days
• Field of Search: 424/400, 424/484, 427/2, 128/419
• US Class Current: 424/400
• CPC Class Codes: A61F 2310/00161 Carbon; Graphite
• CPC Class Codes: A61L 27/08 Carbon ; Graphite
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: C08J 9/26 by elimination of a solid phase from a macromolecular composition or article, e.g. leaching out
• CPC Class Codes: C08J 9/405 with polymerisable compounds

Abstract

The present invention is directed to methods of making a porous device utilizing at least one removable open-cell porous mold form comprising particles formed and shaped into a solidified mass of continuously interconnected particles defining continuously interconnected pores and connecting interstices. The primary mold form is made from a selected material comprising particles having predetermined sizes and shapes which is capable of forming a stable mold form under selected conditions and of being removed under selected conditions. The primary mold form can be used to mold a porous device directly or to mold a secondary mold form. Similarly, the secondary mold form can be used to mold a porous device directly or to mold a tertiary mold form. Depending on the number of mold forms used, the porous device contains pores and pore interconnections corresponding to either the continuously interconnected particles, or to the continuously interconnected pores.

Claims

1. A method of forming a device including one or more porous portions for promoting neovascularization and ingrowth of vascularized tissue, each of said porous portions comprising continuously interconnected pores, said pores being each connected to at least one adjacent pore by pore interconnections and said pores and pore interconnections having a substantially smoothly flowing configuration, said method comprising the steps of:

(a) obtaining a selectively removable open-cell porous mold form comprising particles formed into a shaped and solidified mass of continuously interconnected particles defining continuously interconnected pores, said pores being each connected to at least one adjacent pore by pore interconnections and said pores and pore interconnections having a substantially smoothly flowing configuration, said mold form consisting of a material which can be desolidified upon exposure to a selected condition;

(b) selectively filling the pores and pore interconnections of said mold form with a selected moldable material such that the mold form mass is maintained;

(c) substantially solidifying said moldable material; and

(d) exposing said mold form filled with solidified moldable material to a selected condition to desolidify and thereby selectively remove said mold form from contact with the solidified material within the pores and pore interconnections of the mold form to thereby form the device having a porous portion with substantially continuously interconnected pores.

2. The method of claim 1 wherein the mold form obtained in step (a) comprises a material selected from the group consisting of polymers, ceramics, metals, biologic derivative material and combinations thereof.

3. The method of claim 1 wherein step (b) comprises selectively controlling the introductory location, the amount, and the placement of the moldable material into the mold form during filling to thereby affect the size, shape, and position of the porous and the non-porous portions within the device.

4. The method of claim 3 wherein step (b) comprises selectively not filling a portion of the mold form to thereby form a void within the device.

5. The method of claim 4 wherein said void is formed with a porous surface.

6. The method of claim 4 wherein said void is formed with a non-porous surface.

7. The method of claim 1 wherein the selected condition for desolidifying and selectively removing the mold form is dissolution, melting, burning, sublimation or chemical or biological degradation.

8. The method of claim 1 wherein the selected moldable material of step (b) is a precursor material to the solidified moldable material of step (d).

9. The method of claim 1 wherein the selected moldable material comprises a material selected from the group consisting of polymers, ceramic material, metals, biologic derivative material and combinations thereof.

10. The method of claim 1 wherein the selected moldable material is a polymer material which polymerizes in step (d) to form a substantially flexible device.

11. The method of claim 1 wherein the selected moldable material is a polymer which polymerizes in step (d) to form a substantially rigid device.

12. The method of claim 1 wherein the selected moldable material comprises a pharmaceutical composition.

13. The method of claim 1 wherein the mold form of step (a) comprises impregnated fibers extending into the pores and pore interconnections such that, when the mold form is removed in step (d), said fibers are embedded within the selected solidified moldable material to thereby extend into the continuously interconnected pores of the porous portion of the device.

14. The method of claim 1 wherein step (b) comprises filling the pores and pore interconnections of the mold form with the selected moldable material in a precursor liquid phase, said liquid phase being substantially solidifiable into a solid phase.

15. The method of claim 1 wherein the selected mold form particles of step (a) comprises sugar.

16. The method of claim 15 wherein the selected moldable material of step (b) comprises a polymer material.

17. The method of claim 16 wherein the polymer material is silicone rubber.

18. The method of claim 15 wherein the selected moldable material of step (b) comprises a ceramic material.

19. The method of claim 1 wherein the device having a porous portion with substantially continuously interconnected pores formed in step (d) is a secondary mold form which is subsequently treated according to steps (b), (c), and (d) to thereby form a device having a porous portion with substantially continuously interconnected pores.

20. A method of forming a device including one or more porous portions for promoting neovascularization and ingrowth of vascularized tissue, each of said porous portions comprising continuously interconnected pores, said pores being each connected to at least one adjacent pore by pore interconnections and said pores and pore interconnections having a substantially smoothly flowing configuration, said method comprising the steps of:

(a) obtaining a primary selectively removable open-cell porous mold form comprising particles formed into a shaped and solidified mass of continuously interconnected particles defining continuously interconnected pores, said pores being each connected to at least one adjacent pore by pore interconnections and said pores and pore interconnections having a substantially smoothly flowing configuration, said mold form consisting of a first material which can be desolidified upon exposure to a selected condition;

(b) forming a secondary selectively removable open-cell porous mold form comprising a selected solidifiable material which can be desolidified upon exposure to a selected condition by the steps of;

i) selectively filling the pores and pore interconnections of the primary mold form with the selected solidifiable material such that the primary mold form mass is maintained; and

ii) substantially solidifying said selected solidifiable material to thereby form said secondary mold form as a mirror image of said primary mold form;

iii) exposing said primary mold form filled with said selected solidified material to a selected condition to desolidify and thereby selectively remove said primary mold form from contact with the solidified material within the pores and pore interconnections of said primary mold form to thereby form the said secondary mold form;

(c) selectively filling the pores and pore interconnections of said secondary mold form with a selected moldable material such that the secondary mold form mass is maintained;

(d) substantially solidifying said moldable material; and

(e) exposing said secondary mold form filled with said solidified moldable material to a selected condition to desolidify and thereby selectively remove said secondary mold form from contact with the solidified material within the pores and pore interconnections of the secondary mold form to thereby form the device having a porous portion with continuously interconnected pores.

21. The method of claim 20 wherein the primary mold form comprises sugar.

22. The method of claim 21 wherein the secondary mold form comprises a thermoplastic material.

23. The method of claim 22 wherein the selected moldable material comprises a ceramic material.

24. The method of claim 21 wherein the primary mold form comprises a thermoplastic material.

25. The method of claim 24 wherein the secondary mold form comprises a ceramic material.

26. The method of claim 25 wherein the moldable material comprises molten metal.

27. The method of claim 26 wherein step (b(iii)) occurs simultaneously with step (c), said simultaneous step comprising selectively centrifugally casting said molten metal material into said secondary ceramic mold form to thereby remove said primary thermoplastic mold form by melting with said molten metal while simultaneously filling said secondary ceramic mold form with said molten metal.

28. A method of forming a device including one or more porous portions for promoting neovascularization and ingrowth of vascularized tissue, each of said porous portions comprising continuously interconnected pores, said pores being each connected to at least one adjacent pore by pore interconnections and said pores and pore interconnections having a substantially smoothly flowing configuration, said method comprising the steps of:

(a) obtaining a primary selectively removable open-cell porous mold form comprising particles formed into a shaped and solidified mass of continuously interconnected particles defining continuously interconnected pores, said pores being each connected to at least one adjacent pore by pore interconnections and said pores and pore interconnections having a substantially smoothly flowing configuration, said primary mold form consisting of a material which can be desolidified upon exposure to a selected condition;

(b) forming a secondary selectively removable open-cell porous mold form comprising a selected solidifiable material which can be desolidified upon exposure to a selected condition by the steps of;

i) selectively filling the pores and pore interconnections of the primary mold form with the selected solidifiable material such that the primary mold form mass is maintained; and

ii) substantially solidifying said selected solidifiable material to thereby form said secondary mold form as a mirror image of said primary mold form;

iii) exposing said primary mold from filled with said selected solidified material to a selected condition to desolidify and thereby selectively remove said primary mold form from contact with the solidified material within the pores and pore interconnections of said primary mold form to thereby form said secondary mold form;

(c) forming a tertiary selectively removable open-cell porous mold form comprising a second selected solidifiable material by the steps of;

i) selectively filling the pores and pore interconnections of the secondary mold form with the second selected solidifiable material such that the configuration of said secondary mold form mass is maintained; and

ii) substantially solidifying said second selected solidifiable material to thereby form said tertiary mold form as a mirror image of said secondary mold form;

iii) exposing said secondary mold form filled with said second selected solidified material to a selected condition to desolidify and thereby selectively remove said secondary mold form from contact with the solidified material within the pores and pore interconnections of said secondary mold form to thereby form said tertiary mold form;

(d) selectively filling the pores and pore interconnections of said tertiary mold form with a selected moldable material such that the tertiary mold form mass is maintained;

(e) substantially solidifying said moldable material; and

(f) exposing said tertiary mold form filled with said solidified moldable material to a selected condition to desolidify and thereby selectively remove said tertiary mold form from contact with the solidified material within the pores and pore interconnections of said tertiary mold form to thereby form the device having a porous portion with continuously interconnected pores.

29. The method of claim 28 wherein the primary mold form comprises sugar.

30. The method of claim 29 wherein the secondary mold form comprises a thermoplastic material.

31. The method of claim 30 wherein the tertiary mold form comprises a ceramic material.

32. The method of claim 31 wherein the moldable material comprises molten metal.

33. The method of claim 32 wherein step (c(iii)) occurs simultaneously with step (d), said simultaneous step comprising selectively centrifugally casting said molten metal material into said tertiary ceramic mold form to thereby remove said secondary thermoplastic mold form by melting with said molten metal while simultaneously filling said tertiary ceramic mold form with said molten metal.

34. A method of forming a device including one or more porous portions for promoting neovascularizating and ingrowth of vascularized tissue, each of said porous portions comprising continuously interconnected pores, said pores being each connected to at least one adjacent pore by pore interconnections and said pores and pore interconnections having a substantially smoothly flowing configuration, said method comprising the steps of:

(a) obtaining a selectively removable open-cell porous mold form comprising particles of a selected biodegradable material formed into a shaped and solidified mass of continuously interconnected particles defining continuously interconnected pores, said pores being each connected to at least one adjacent pore by pore interconnections and said pores and pore interconnections having a substantially smoothly flowing configuration;

(b) selectively filling the pores and pore interconnections of said mold form with a selected moldable material; and

(c) implanting the filled mold form into the body of a human or animal such that said mold form biodegrades in situ to thereby form the device having a porous portion with continuously interconnected pores.

35. The method of claim 34 wherein the biodegradable mold form comprises a pharmaceutical composition which is released in situ during the biodegradation of the mold form.

36. A method of forming a device including one or more porous portions for promoting neovascularization and ingrowth of vascularized tissue, said method comprising the steps of:

(a) obtaining a selectively removable open-cell porous mold form comprising particles formed into a shaped and solidified mass of continuously interconnected particles defining continuously interconnected pores, said pores being each connected to at least one adjacent pore by pore interconnections and said pores and pore interconnections having a substantially smoothly flowing configuration, said mold form consisting of a material which can be desolidified upon exposure to a selected condition;

(b) selectively filling the pores and pore interconnections of said mold form with a selected moldable material such that the mold form mass is maintained;

(c) substantially solidifying said moldable material; and

(d) exposing said mold form filled with solidified moldable material to a selected condition to desolidify and thereby selectively remove said mold form from contact with the solidified material within the pores and pore interconnections of the mold form to thereby form the device having a porous portion with substantially continuously interconnected pores.