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Biocompatible and biostable implantable medical device / Allergan, Inc.




Title: Biocompatible and biostable implantable medical device.
Abstract: 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. One layer of the coating combinations can be a tie layer. Another layer of the coating combinations can be a layer formed on top of the tie layer, and having biocompatible and biostable properties. ...


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USPTO Applicaton #: #20110270022
Inventors: Babak Honaryar, Mike Augarten, Marcos Borrell, Kaustubh S. Chitre, Christian Y. Perron, Sean Snow, Erik Torjesen, Nikhil S. Trilokekar, Christopher R. Deuel


The Patent Description & Claims data below is from USPTO Patent Application 20110270022, Biocompatible and biostable implantable medical device.

RELATED APPLICATIONS

This application claims priority to and the benefit of U.S. Provisional Patent Application No. 61/330,266, entitled “BIOCOMPATIBLE AND BIODURABLE, ELECTRONICALLY ENHANCED ACCESS PORT FOR A FLUID FILLED IMPLANT” filed on Apr. 30, 2010, the entire disclosure of which is incorporated herein by reference.

FIELD

The present invention broadly relates to medical devices and more specifically, to a biocompatible and biostable implantable medical device.

BACKGROUND

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There are numerous varieties of implantable medical devices, such as fluid filled surgical implants presently comprising, or which may in the future comprise, access ports, for hydraulically adjustable gastric bands.

An exemplary hydraulic adjustable gastric band comprises a saline solution inside of one or more inflatable portions (e.g., silicone shells) positioned on the stomach surface of the ring of the gastric band to adjust the gastric band through a variety of diameters. As the inflatable portion is inflated it reduces the stoma of the gastric band and when the inflatable portion is deflated it increases the stoma of the gastric band. The saline solution is added to or removed from the inflatable portion via an access port fixed beneath the skin of the patient in the abdomen on the rectus muscle sheath using a fine needle to find the right level of restriction.

An exemplary gastric band (hydraulic, hydraulic-mechanical hybrid, or otherwise) may additionally, or alternatively, comprise an access port coupled with an override mechanism to rapidly remove fluid or gel from the implant in the event of an emergency.

Each of the foregoing implants, as well as others, comprise access ports that may be candidates for various electronics based enhancements, e.g., an access port fitted with a pressure sensor and/or an access port that transmits a signal for easier detection of its location within the body of the patient.

Furthermore, incorporation of electronic components into such access ports has not been workable at least in part because of bioincompatibility. More specifically, these enhancements and the associated electronics have heretofore caused cytotoxicity and/or been compromised by the body's interstitial fluids over time.

Spehr (U.S. Pat. No. 6,240,320) discloses that biocompatible material such as diamond-like carbon, sapphire, parylene compounds, diamond, or like materials may be used to coat an exterior of the electrode member. However, Spehr suffers from the drawback that it does not use, for example, a tie layer to enhance adhesion of the biocompatible material. Furthermore, Spehr does not disclose that several types of coatings can be used in conjunction with each other to address all of the essential requirements for a successful long-term function. Such requirements can include, for example, long-term biocompatibility (10+ years), ability to coat relatively uniformly and thoroughly over an abrupt topology in a conformal manner, provide a significant barrier against water molecule penetration or transmission, utilize a deposition temperature and other processing parameters which are not too harsh for the substrate material and the electromechanical device being coated, non-conductivity of the portion of the coating that directly contacts an electrical equipment, and ability to stay attached to the substrate materials and retain its moisture barrier properties despite (i) abrasion caused by handling during assembly; (ii) thermal expansion and contraction during shipping and handling and then due to operation of the device after implantation; (iii) material aging; (iv) chemical interaction between adjacent materials; and (v) exposure to sterilization, such as heat, chemicals or radiation.

Adamis (U.S. Pat. No. 7,563,255) discloses coating devices contacting tissue or bio fluid with biocompatible material, such as, polyethyleneglycol, polyvinylchloride, polycarbonate, polysulfone, polytetrafluoroethylene, parylene, titanium or the like, prior to implantation. However, Adamis suffers from the drawback that it does not use, for example, a tie layer to enhance adhesion of the biocompatible material. Furthermore, Adamis does not disclose that several types of coatings can be used as a multilayered combination to address all of the requirements listed above.

SUMMARY

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In accordance with exemplary embodiments, the present invention provides for a biocompatible and biostable medical device that addresses the needs in the prior art.

In accordance with exemplary embodiments, the present invention provides for a medical device, such as an access port configured to detect the pressure of a fluid within the implant. In accordance with other exemplary embodiments, the present invention provides for various novel and nonobvious coating combinations designed to promote biostability and biocompatibility of electro-mechanical components in the medical devices, including, but not limited to, those disclosed herein.

In one embodiment, the present invention is an access port for a gastric band including a housing, and an electro-mechanical component located within the housing, wherein the electro-mechanical component is coated with a coating combination.

In another embodiment, the present invention is an access port for a gastric band including a penetrable septum defining an outer wall of a housing, a conduit configured to provide fluid communication between the penetrable septum and the gastric band, a pressure sensor in fluid communication with a fluid within the gastric band, and a printed circuit board assembly connected to the pressure sensor, wherein the printed circuit board assembly is coated with a coating combination.

In yet another embodiment, the present invention is an access port for a gastric band including a penetrable septum defining an outer wall of a housing, a conduit configured to provide fluid communication between the penetrable septum and the gastric band, and a pressure sensor in fluid communication with a fluid within the gastric band, wherein the pressure sensor is coated with a coating combination.

In still another embodiment, the present invention is a method for protectively coating a long term medical device including coating the long term medical device with a tie layer, and coating the long term medical device with a biostable and biocompatible material.

In one embodiment, the present invention is an implantable medical device including an electro-mechanical component coated with a coating combination including a tie layer.

BRIEF DESCRIPTION OF THE DRAWINGS

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The exemplary embodiments of the present invention will be described in conjunction with the accompanying drawing FIGS. in which like numerals denote like elements and:

FIG. 1A illustrates an access port comprising a pressure sensor according to an embodiment of the present invention;

FIG. 1B illustrates a cross sectional view of an access port comprising a pressure sensor according to an embodiment of the present invention;

FIG. 2 illustrates a printed circuit board assembly coated with various layers according to an embodiment of the present invention;

FIG. 3 illustrates a printed circuit board assembly coated with various layers according to an embodiment of the present invention;

FIG. 4 illustrates a printed circuit board assembly coated with various layers according to an embodiment of the present invention;

FIG. 5 illustrates an electro-mechanical component for a medical device coated with various layers according to an embodiment of the present invention; and

FIG. 6 depicts a process according to an embodiment of the present invention.

DETAILED DESCRIPTION

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stats Patent Info
Application #
US 20110270022 A1
Publish Date
11/03/2011
Document #
File Date
12/31/1969
USPTO Class
Other USPTO Classes
International Class
/
Drawings
0


Implantable Medical Device Layer Medical Device

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20111103|20110270022|biocompatible and biostable 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. One layer of the coating |Allergan-Inc
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