Method of fabricating medical devices and medical devices made thereby
A method of fabricating medical devices and medical devices made from the method of fabricating a medical device, the medical device, without being exhaustive, may be a medical instrument, an implant, a prosthetic, a body support structure or the like. The method includes work-hardening a work-hardenable metal to achieve a desired microstructure of the metal, then fabricating a medical device in accordance with the desired microstructure utilizing the work-hardened metal. In one form, the desired microstructure is an elongated grain structure. The medical device is created from the grain-elongated metal such that the medical device is oriented relative to the plane of grain elongation. In a particular form of the invention, the medical device is a curved spine plate wherein elongated grains of the work hardened metal are oriented in a plane normal to a curvature of the spine plate. Work-hardening includes forging, cold rolling or hot rolling, and annealing prior to use in medical device fabrication. This creates a metal implant stock that has more strength and flexibility in compression and bending than without undergoing the present work-hardening. These properties are exploited in medical device design, fabrication, fabrication orientation and/or the like to create medical devices such as super strong implants.
1 . A method of fabricating a medical device comprising the steps of:
work hardening a work-hardenable metal to achieve a desired microstructure of the metal; and
producing a medical device in accordance with the achieved microstructure of the metal.
2 . The method of claim 1 , wherein the step of work hardening a work-hardenable metal comprises work hardening by one of forging, cold rolling, hot rolling, and annealing.
3 . The method of claim 1 , wherein the step of work hardening a work-hardenable metal comprises work hardening by one or more of forging, cold rolling, hot rolling, and annealing.
4 . The method of claim 1 , wherein the step of work hardening a work-hardenable metal comprises work hardening by a series of forging, cold rolling, hot rolling, and annealing.
5 . The method of claim 1 , wherein the achieved microstructure of the metal comprises grain elongation.
6 . The method of claim 5 , wherein the step of producing a medical device with the achieved microstructure of the metal includes the step of orienting the medical device relative to the plane of grain elongation.
7 . The method of claim 6 , wherein the medical device comprises a spine plate.
8 . The method of claim 7 , wherein the elongated grains of the work hardened metal are oriented in a plane normal to a longitudinal axis of the spine plate.
9 . The method of claim 6 , wherein the medical device comprises a curved spine plate with the elongated grains of the work hardened metal oriented in a plane normal to the curvature of the spine plate.
10 . A medical device comprising:
a body fabricated from a work-hardenable metal that has been work hardened to achieve a desired microstructure of the metal; and
wherein the achieved microstructure has characteristics that aid in performance of the medical device.
11 . The medical device of claim 10 , wherein the work-hardened metal is achieved by one of forging, cold rolling, hot rolling, and annealing.
12 . The medical device of claim 10 , wherein the of work hardening a work-hardenable metal comprises work hardening by one or more of forging, cold rolling, hot rolling, and annealing.
13 . The medical device of claim 10 , wherein the step of work hardening a work-hardenable metal comprises work hardening by a series of forging, cold rolling, hot rolling, and annealing.
14 . The medical device of claim 10 , wherein the achieved microstructure of the metal comprises grain elongation.
15 . The medical device of claim 14 , wherein the body is fabricated through orienting the medical device relative to the plane of grain elongation.
16 . The medical device of claim 15 , wherein the medical device comprises a spine plate.
17 . The medical device of claim 16 , wherein the elongated grains of the work hardened metal are oriented in a plane normal to a longitudinal axis of the spine plate.
18 . The medical device of claim 15 , wherein the medical device comprises a curved spine plate with the elongated grains of the work hardened metal oriented in a plane normal to the curvature of the spine plate.