Prosthesis device fabrication

• US 4,636,219 A
• Filed: 12/05/1985
• Issued: 01/13/1987
• Est. Priority Date: 12/05/1985
• Status: Expired due to Term

• Current Assignee: Anspach Manufacturing, Inc.
• Original Assignee: Techmedica, Inc.
• Inventors: Raggio, Charles M., Woznick, Chuck P., Pratt, Clyde R., Carignan, Roger G.
• Primary Examiner(s): NOT, DEFINED
• Application Number:
  US06/804,927
• Time in Patent Office: 404 Days
• Field of Search: 623/16, 623/18, 623/20, 623/22, 623/23, 228/193, 228/194, 228/195
• US Class Current: 623/23.3
• CPC Class Codes: A61B 90/00 Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges protective face masks A41D13/11; surgeon's or patient's gowns or dresses A41D13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M1/00
• CPC Class Codes: A61F 2/30907 Nets or sleeves applied to surface of prostheses or in cement
• CPC Class Codes: A61F 2/36 Femoral heads ; Femoral endoprostheses
• CPC Class Codes: A61F 2/367 Proximal or metaphyseal parts of shafts trochanteric devices connected to said proximal parts A61F2/30739
• CPC Class Codes: A61F 2002/30009 differing in fibre orientations
• CPC Class Codes: A61F 2002/30322 differing in surface structures
• CPC Class Codes: A61F 2002/30733 Inserts placed into an endoprosthetic cavity, e.g. for modifying a material property
• CPC Class Codes: A61F 2002/30805 Recesses of comparatively large area with respect to their low depth
• CPC Class Codes: A61F 2002/30915 made of a stack of bonded perforated sheets, grids or wire meshes
• CPC Class Codes: A61F 2002/30929 having at least two superposed coatings
• CPC Class Codes: A61F 2002/3096 trimmed or cut to a customised size
• CPC Class Codes: A61F 2002/30967 Diffusion bonding
• CPC Class Codes: A61F 2002/30968 Sintering
• CPC Class Codes: A61F 2002/3462 having a frustoconical external shape, e.g. entirely frustoconical
• CPC Class Codes: A61F 2002/3466 having a cylindrical external shape, e.g. entirely cylindrical
• CPC Class Codes: A61F 2250/0026 differing in surface structures
• CPC Class Codes: A61F 2250/0028 differing in fibre orientations
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00407 Coating made of titanium or of Ti-based alloys
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: B22F 3/002 : Manufacture of articles essentially made from metallic fibres
• CPC Class Codes: Y10T 428/12347 : Plural layers discontinuously bonded [e.g., spot-weld, mechanical fastener, etc.]
• CPC Class Codes: Y10T 428/12444 : Embodying fibers interengaged or between layers [e.g., paper, etc.]
• CPC Class Codes: Y10T 428/12479 : Porous [e.g., foamed, spongy, cracked, etc.]

Abstract

A process is disclosed for fabricating a biocompatible mesh screen structure for bonding to a prosthetic substrate. The process comprises providing from four to eight layers of a mesh comprising a titanium alloy and subjecting the layered structure to a temperature below the beta-transformation temperature of the alloy and a pressure of about 1300 to 1500 psi. The heating and pressing are carried out in a furnace maintained at a temperature of about 1600° to 1725° F., which is evacuated to a vacuum of less than about 10^-4 torr. The process of the invention provides a product retaining the strength of the alloy and having a well-characterized pore structure. Further, the layered mesh composite may be bonded to a thin substrate and readily formed into complex shapes.

Claims

1. A process of fabricating a biocompatible mesh screen structure for bonding to a prosthetic substrate, the process comprising:

(a) providing from four to eight layers of a mesh comprising a titanium alloy; and

(b) subjecting the layered structure to a processing temperature below the beta-transformation temperature of said alloy and a pre-determined pressure for a pre-selected period of time, the heating and pressing being carried out in a vacuum furnace maintained at a temperature of about 25°

to 125°

F. above said processing temperature and at a pre-determined vacuum.

2. The process of claim 1 wherein said alloy comprises a member selected from the group consisting of commercially pure titanium and Ti-6Al-4V.

3. The process of claim 2 wherein said processing temperature is at least about 1600°

F., said pre-determined pressure ranges from about 1300 to 1500 psi, said pre-selected period of time ranges from about 12 to 24 minutes and said pre-determined vacuum is less than about 10^-4 torr.

4. A process for fabricating a biocompatible mesh screen structure for bonding to a prosthetic substrate, the processing comprising:

(a) providing from four to eight layers of a mesh comprising a titanium alloy; and

(b) subjecting the layered structure to a processing temperature below the beta-transformation temperature of said alloy and a pressure of about 1300 to 1500 psi for a period of time of about 12 to 24 min, the heating and pressing being carried out in a furnace maintained at a temperature ranging from about 1600°

to 1725°

F., depending upon the alloy, said furnace evacuated to provide a vacuum of less than about 10^-4 torr.

5. The process of claim 4 wherein said mesh comprises a member selected from the group consisting of commercially pure titanium and Ti-6Al-4V.

6. The process of claim 5 wherein said processing temperature is about 1600°

for commercially pure Ti and about 1650°

F. for Ti-6Al-4V.

7. The process of claim 4 wherein the pore size of said mesh ranges from about 15 to 860 micrometers.

8. The process of claim 7 wherein said pore size averages about 235 micrometers.

9. The process of claim 4 wherein said mesh is comprised of wires having a diameter of about 0.01 inch.

10. The process of claim 4 wherein each layer is biased 45°

with respect to its neighboring layers.

11. Product produced by the process of claim 4.

12. A process for fabricating a biocompatible mesh screen structure bonded to a prosthetic substrate comprising:

(a) providing from four to eight layers of a mesh comprising a titanium alloy;

(b) providing a substrate of a titanium alloy; and

(c) subjecting the structure to a processing temperature below the beta-transformation temperature of said alloy and a pressure of about 1300 to 1500 psi for a period of time of about 12 to 24 minutes, the heating and pressing being carried out at a furnace maintained at a temperature ranging from about 1600°

to 1725°

F., said furnace being evacuated to provide a vacuum of less than about 10^-4 torr.

13. The process of claim 12 wherein said titanium alloy comprises a member selected from the group consisting of commercially pure titanium and Ti-6Al-4V.

14. The process of claim 13 wherein said processing temperature is about 1600°

F. for commercially pure Ti and about 1650°

F. for Ti-6Al-4V.

15. The process of claim 12 wherein said prosthetic substrate comprises a titanium alloy.

16. Product produced by the process of claim 12.