BIOCOMPATIBLE AND BIOSTALE IMPLANTABLE MEDICAL DEVICE
The present invention is related to a biocompatible and biostable implantable medical device. The present invention can include an implantable medical device including an electro-mechanical component. The electro-mechanical component can be coated with various novel and nonobvious coating combinations designed to promote biocompatibility and biostability.
1 . A pressure sensor for use with a medical implantable device, the pressure sensor comprising:
a circuit board having circuit components mounted thereon;
a first layer of a first material encapsulating the circuit board and acting as a moisture barrier for the circuit board, the first layer for conforming to a surface topology of the circuit board to create an even surface, and for improving the biocompatibility of the circuit board;
a second layer of a second material, the second layer positioned on the first layer and acting as a moisture barrier for the first layer, the second layer for filling one or more holes of the first layer;
a third layer of a third material positioned on the second layer and acting as a moisture barrier for the second layer; and
a fourth layer of a fourth material positioned on the third layer, the fourth layer for improving the biocompatibility of the circuit board.
2 . The pressure sensor of claim 1 wherein the first material is Epoxy.
3 . The pressure sensor of claim 2 wherein an outer surface of the first layer is at least about 0.020 inches apart from a highest component of the circuit components mounted thereon the circuit board.
4 . The pressure sensor of claim 3 wherein the second material is parylene.
5 . The pressure sensor of claim 4 wherein the second layer has a thickness in the range of about 0.004 to about 0.008 inches.
6 . The pressure sensor of claim 5 wherein the third material is a diamond-like carbon (DLC).
7 . The pressure sensor of claim 6 wherein the third layer has a thickness of at least about 4 μ-inches.
8 . The pressure sensor of claim 7 wherein the fourth material is silicone rubber.
9 . The pressure sensor of claim 8 wherein the fourth layer has a thickness in the range of about 0.02 to about 0.06 inches.
10 . A gastric banding system for the treatment of obesity, the gastric banding system comprising:
a gastric band configured to be disposed about an esophageal-gastric junction of a patient, the gastric band including a ring coupled to an inflatable portion;
a tubing fluidly coupled to the inflatable portion at a first end of the tubing, the tubing for carrying fluid to inflate the inflatable portion of the gastric band and for carrying fluid from the inflatable portion to deflate the inflatable portion; and
an access port fluidly coupled to the tubing at a position located at a second end of the tubing, the access port including a electro-mechanical pressure sensor, the electro-mechanical pressure sensor including:
a circuit board having circuit components mounted thereon;
a first layer of a first material encapsulating the circuit board, the first layer for conforming to a surface topology of the circuit board to create an even surface, and for improving a biocompatibility of the access port and providing a barrier against moisture,
a second layer of a second material, the second layer positioned over the first layer, the second layer for filling one or more holes of the first layer, and for further preventing the moisture from contacting the circuit board, and for improving the biocompatibility of the access port,
a third layer of a third material positioned over the second layer, the third layer for preventing moisture from contacting the second layer, and for improving the biocompatibility of the access port, and
a fourth layer of a fourth material positioned over the third layer, the fourth layer for further improving the biocompatibility of the access port, and for providing a softer contact with surrounding body tissue.
11 . The gastric banding system of claim 10 wherein the first material is Epoxy, and wherein an outer surface of the first layer is at least about 0.020 inches apart from a highest component of the circuit components mounted thereon the circuit board.
12 . The gastric banding system of claim 11 wherein the second material is parylene, and wherein the second layer has a thickness in the range of about 0.004 to about 0.008 inches.
13 . The gastric banding system of claim 12 wherein the third material is a diamond-like carbon (DLC), and wherein the third layer has a thickness of at least about 4 μ-inches.
14 . The gastric banding system of claim 13 wherein the fourth material is silicone rubber, and wherein the fourth layer has a thickness in the range of about 0.02 to about 0.06 inches.
15 . A method for protectively coating a medical device having an exposed circuit board, the medical device for implantation into the human body for the treatment of obesity or obesity-related diseases, the method comprising:
applying a first layer of a first material to fully encapsulate the circuit board, the first layer for conforming to a surface topology of the circuit board to create an even surface, and for improving the biocompatibility of the circuit board;
applying a second layer of a second material onto the first layer, the second layer for filling one or more holes of the first layer, and for preventing moisture from contacting the circuit board;
applying a third layer of a third material onto the second layer, the third layer for preventing moisture from contacting the second layer; and
applying a fourth layer of a fourth material onto the third layer, the fourth layer for improving the biocompatibility of the circuit board.
16 . The method of claim 15 wherein the first material is Epoxy, and wherein an outer surface of the applied first layer is at least about 0.020 inches apart from a highest component of the circuit components mounted thereon the circuit board.
17 . The method of claim 16 wherein the second material is parylene, and wherein the applied second layer has a thickness in the range of about 0.004 to about 0.008 inches.
18 . The method of claim 17 wherein the third material is a diamond-like carbon (DLC), and wherein the applied third layer has a thickness of at least about 4 μ-inches.
19 . The method of claim 18 wherein the fourth material is silicone rubber, and wherein the applied fourth layer has a thickness of at least about 0.02 inches.
20 . The method of claim 18 wherein the fourth material is silicone rubber, and wherein the applied fourth layer has a thickness in the range of about 0.02 to about 0.06 inches.