System and method for the manufacture of surgical blades

• US 7,105,103 B2
• Filed: 03/10/2003
• Issued: 09/12/2006
• Est. Priority Date: 03/11/2002
• Status: Active Grant

• Current Assignee: Beaver-Visitec International, Inc (BVI Medical, Inc.)
• Original Assignee: Becton, Dickinson & Co
• Inventors: Keenan, Joseph Francis, Hughes, James Joseph, Daskal, Vadim Mark
• Primary Examiner(s): DEO, DUY VU NGUYEN
• Application Number:
  US10/383,573
• Publication Number:
  US 20030199165A1
• Time in Patent Office: 1,282 Days
• Field of Search: 438/714, 438/719, 438/745, 438/753
• US Class Current: 216/101
• CPC Class Codes: A61B 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• CPC Class Codes: A61B 17/3211 Surgical scalpels, knives; Accessories therefor
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: B28D 5/022 by cutting with discs or wheels

Abstract

A method for manufacturing surgical blades from either a crystalline or poly-crystalline material, preferably in the form of a wafer, is disclosed. The method includes preparing the crystalline or poly-crystalline wafers by mounting them and machining trenches into the wafers. The methods for machining the trenches, which form the bevel blade surfaces, include a diamond blade saw, laser system, ultrasonic machine, and a hot forge press. The wafers are then placed in an etchant solution which isotropically etches the wafers in a uniform manner, such that layers of crystalline or poly-crystalline material are removed uniformly, producing single or double bevel blades. Nearly any angle can be machined into the wafer which remains after etching. The resulting radii of the blade edges is 5–500 nm, which is the same caliber as a diamond edged blade, but manufactured at a fraction of the cost.

Claims

1. A method for manufacturing a cutting device from a crystalline material, the method comprising:

machining at least one blade profile in a wafer of crystalline material on a first side of the wafer of the crystalline material;

isotropically etching the wafer of crystalline material to form at least one surgical blade comprising the at least one blade profile; and

singulating the at least one surgical blades.

2. The method according to claim 1, wherein the machining step comprises:

machining at least one blade profile in the wafer of crystalline material with a dicing saw blade.

3. The method according to claim 1, wherein the machining step comprises:

machining at least one blade profile in the wafer of crystalline material with a laser beam.

4. The method according to claim 3, wherein the laser beam is produced by an excimer laser or a laser waterjet.

5. The method according to claim 1, wherein the machining step comprises:

machining at least one blade profile in the wafer of crystalline material with an ultrasonic machine.

6. The method according to claim 1, wherein the machining step comprises:

machining at least one blade profile in the wafer of crystalline material with a hot forging process.

7. The method according to claim 1, wherein the etching step comprises:

placing the wafer of crystalline material with at least one blade profile on a wafer boat;

immersing the wafer boat and wafer of crystalline material with at least one blade profile in an isotropic acid bath;

etching the crystalline material in a uniform manner such that the crystalline material is removed in a uniform manner on any exposed surface, whereby a sharp surgical blade edge is etched in the shape of the at least one blade profile.

8. The method according to claim 7, wherein the isotropic acid bath comprises:

a mixture of hydrofluoric acid, nitric acid and acetic acid.

9. The method according to claim 7, wherein the isotropic acid bath comprises:

a mixture of hydrofluoric acid, nitric acid and water.

10. The method according to claim 1, wherein the etching step comprises:

placing the wafer of crystalline material with at least one blade profile in a wafer boat;

spraying a spray etchant at the wafer boat and wafer of crystalline material with at least one blade profile;

etching the crystalline material in a uniform manner with the spray etchant such that the crystalline material is removed in a uniform manner on any exposed surface, whereby a sharp surgical blade edge is etched in the shape of the at least one blade profile.

11. The method according to claim 1, wherein the etching step comprises:

placing the wafer of crystalline material with at least one blade profile on a wafer boat;

immersing the wafer boat and wafer of crystalline material with at least one blade profile in an isotropic xenon difluoride, sulfur hexafluoride or similar fluorinated gas environment;

etching the crystalline material in a uniform manner with the isotropic xenon difluoride, sulfur hexafluoride or similar fluorinated gas such that the crystalline material is removed in a uniform manner on any exposed surface, whereby a sharp surgical blade edge is etched in the shape of the at least one blade profile.

12. The method according to claim 1, wherein the etching step comprises:

placing the wafer of crystalline material with at least one blade profile in a wafer boat;

immersing the wafer boat and wafer of crystalline material with at least one blade profile in an electrolytic bath;

etching the crystalline material in a uniform manner with the electrolytic bath such that the crystalline material is removed in a uniform manner on any exposed surface, whereby a sharp surgical blade edge is etched in the shape of the at least one blade profile.

13. The method according to claim 1, wherein the singulating step comprises:

dicing the machined wafer of crystalline material with a dicing blade.

14. The method according to claim 1, wherein the singulating step comprises:

dicing the machined wafer of crystalline material with a laser beam.

15. The method according to claim 1, wherein the laser beam is produced by an excimer laser or a laser waterjet.

16. The method according to claim 1, further comprising:

dicing the machined wafer of crystalline material profiles after machining the at least one blade profile in the form of single bevel surgical blade and prior to the step of etching.

17. The method according to claim 16, wherein the dicing step comprises:

dicing the machined wafer of crystalline material with a dicing blade.

18. The method according to claim 16, wherein the dicing step comprises:

dicing the machined wafer of crystalline material with a laser beam.

19. The method according to claim 18, wherein the laser beam is produced by an excimer laser or a laser waterjet.

20. The method for manufacturing a surgical blade from a crystalline material according to claim 1, further comprising:

machining at least one second blade profile in the wafer of crystalline material on a second side of the wafer of crystalline material prior to the step of etching.

21. The method according to claim 20, further comprising:

coating the first side of the machined wafer of crystalline material.

22. The method according to claim 21, wherein the coating step comprises:

coating the first side of the machined wafer of crystalline material with a layer of material selected from the group consisting of silicon nitride, titanium nitride, aluminum titanium nitride, silicon dioxide, silicon carbide, titanium carbide, boron nitride, and diamond-like-crystals.

23. The method according to claim 20, further comprising:

dicing the machined wafer of crystalline material into separated machined double beveled blade profiles after machining the at least one second blade profile in the second side and prior to the step of etching.

24. The method according to claim 23, wherein the dicing step comprises:

dicing the machined wafer of crystalline material with a dicing blade.

25. The method according to claim 23, wherein the dicing step comprises:

dicing the machined wafer of crystalline material with a laser beam.

26. The method according to claim 25, wherein the laser beam is produced by an excimer laser or a laser waterjet.

27. The method according to claim 1, further comprising:

coating the first side of the wafer of crystalline material after the step of machining the wafer of crystalline material; and

mounting the wafer of crystalline material on its first side prior to the step of etching.

28. The method according to claim 27, wherein the coating step comprises:

coating the first side of the formed wafer of crystalline material with a layer of material selected from the group consisting of silicon nitride, titanium nitride, aluminum titanium nitride, silicon dioxide, silicon carbide, titanium carbide, boron nitride, and diamond-like-crystals.

29. The method according to claim 1, wherein the crystalline material comprises silicon.

30. A method for manufacturing a cutting device from a crystalline material, comprising:

mounting a wafer of crystalline material on a mounting assembly;

pre-cutting the mounted wafer of crystalline material, such that a plurality of through hole fiducials are cut to assist in the machining step;

machining at least one blade profile in the wafer of crystalline material on its first side;

etching the wafer of crystalline material to form at least one surgical blade;

singulating the etched crystalline material surgical blades; and

radiating the singulated etched crystalline material surgical blades with ultra-violet light, to separate them from the mounting assembly, in preparation for packaging for sale.

31. The method according to claim 30 wherein the pre-cutting step comprises:

pre-cutting through hole fiducials in the mounted wafer of crystalline material with a laser beam.

32. The method according to claim 31 wherein the laser beam is produced by an excimer laser or a laser waterjet.

33. The method according to claim 30 wherein the pre-cutting step comprises:

pre-cutting through hole fiducials in the mounted wafer of crystalline material using a mechanical machining device.

34. The method according to claim 33 wherein the mechanical machining device comprises a drilling tool, ultrasonic machining tool or a mechanical grinding device.

35. The method according to claim 30 wherein the crystalline material comprises silicon.

36. A method for manufacturing a cutting device from a crystalline material, comprising:

mounting a wafer of crystalline material on a mounting assembly;

pre-cutting the mounted wafer of crystalline material, such that a plurality slots are cut to assist in the machining step;

machining at least one blade profile in the wafer of crystalline material on its first side;

etching the wafer of crystalline material to form at least one surgical blade;

singulating the etched crystalline material surgical blades; and

radiating the singulated etched crystalline material surgical blades with ultra-violet light, to separate them from the mounting assembly, in preparation for packaging for sale.

37. The method according to claim 36 further comprising:

pre-cutting slots in the mounted wafer of crystalline material with a laser beam a distance away from the edge of the crystalline material; and

machining the at least one blade profile with a dicing saw blade that engages the crystalline wafer at the pre-cut slot.

38. The method according to claim 37, wherein the laser beam is produced by an excimer laser or a laser waterjet.

39. The method according to claim 36 further comprising:

pre-cutting slots in the mounted wafer of crystalline material with a mechanical machining device a distance away from the edge of the crystalline material; and

machining the at least one blade profile with a dicing saw blade that engages crystalline wafer at the pre-cut slot.

40. The method according to claim 39, wherein the mechanical machining device comprises a drilling tool, ultrasonic machining tool or a mechanical grinding device.

41. The method according to claim 36 wherein the crystalline material comprises silicon.

42. A method for manufacturing a cutting device, the method comprising:

pre-cutting a wafer of a crystalline material, such that a plurality of through hole fiducials are cut to assist in a machining step;

machining at least one blade profile in the wafer of the crystalline material; and

etching the wafer of crystalline material to form at least one surgical blade.

43. The method according to claim 42, further comprising singulating the at least one surgical blade.

44. The method according to claim 42, wherein the etching of the wafer comprises isotropically etching the wafer of the crystalline material to form the at least one surgical blade comprising the at least one blade profile.

45. The method according to claim 44 further comprising:

mounting the wafer of the crystalline material on a mounting assembly; and

radiating the singulated surgical blade with ultra-violet light, to separate the singulated surgical blade from the mounting assembly.

46. A method for manufacturing a cutting device, the method comprising:

pre-cutting a wafer of a crystalline material, such that a plurality of slots are cut to assist in a machining step;

machining at least one blade profile in the wafer of the crystalline material; and

etching the wafer of crystalline material to form at least one surgical blade.

47. The method according to claim 46, further comprising singulating the at least one surgical blade.

48. The method according to claim 46, wherein the etching of the wafer comprises isotropically etching the wafer of the crystalline material to form the at least one surgical blade comprising the at least one blade profile.

49. The method according to claim 48 further comprising:

mounting the wafer of the crystalline material on a mounting assembly; and

radiating the singulated surgical blade with ultra-violet light, to separate the singulated surgical blade from the mounting assembly.