News Column

Patent Issued for Steroid Eluting Collar Undermold

August 6, 2014



By a News Reporter-Staff News Editor at Biotech Week -- A patent by the inventors Horrisberger, Benn (Blaine, MN); Eggert, Joel T. (Plymouth, MN); Morris, Kimberly A. (Minneapolis, MN), filed on February 6, 2013, was published online on July 22, 2014, according to news reporting originating from Alexandria, Virginia, by NewsRx correspondents (see also Cardiac Pacemakers, Inc.).

Patent number 8784714 is assigned to Cardiac Pacemakers, Inc. (St. Paul, MN).

The following quote was obtained by the news editors from the background information supplied by the inventors: "Various types of medical electrical leads for use in cardiac rhythm management (CRM) and neurostimulation applications are known. In CRM applications, for example, such leads are frequently delivered intravascularly to an implantation location on or within a patient's heart, typically under the aid of fluoroscopy. Once implanted, the lead is coupled to a pulse generator or other implantable device for sensing cardiac electrical activity, delivering therapeutic stimuli, and/or for performing other desired functions within the body. Such leads typically include a distal conductor end with one or more electrodes that contact the heart tissue, and a proximal terminal end that is connected to a pacemaker or defibrillator. The conductor end of the lead can include one or more features such as an active fixation helix or a number of passive tines to facilitate securing the lead to the heart tissue. The terminal end of the lead, in turn, includes one or more electrical contacts that are electrically connected to the electrodes via a number of lead conductors.

"An increase in the stimulation threshold required to electrically stimulate the body can result from the interaction of the electrodes with the body tissue at the site of implantation. In CRM applications involving leads implanted in or near the heart, for example, the capture threshold of the lead can increase due to the formation of scar tissue at the location where the electrodes contact the body tissue. Approaches to reducing the capture threshold have included the incorporation of drug-eluting collars or plugs containing a therapeutic drug such as dexamethasone acetate, which reduces inflammation at the site of contact.

"The incorporation of drug-eluting collars or plugs into medical electrical leads is typically accomplished via an injection molding process in which the collar or plug is pre-formed as a separate component, and then subsequently bonded to the lead body via an adhesive or glue. In the fabrication of medical electrical leads used in CRM and neurostimulation applications, for example, the drug-eluting collar is typically formed in a mold and then adhesively bonded onto a distal portion of the lead, typically adjacent to an electrode located at the distal end of the lead body. In some cases, variability in the contact surface area at the location of the adhesive can cause the rate at which the drug is eluted into the body tissue to vary. Some drug collar bonding techniques can also result in yield fallout and other manufacturing issues."

In addition to the background information obtained for this patent, NewsRx journalists also obtained the inventors' summary information for this patent: "The present disclosure relates to methods of manufacturing implantable medical devices with undermolded features such as steroid-eluting drug collars, visual aids, and/or radioscopic traceable members.

"In Example 1, a method of manufacturing an implantable medical device comprises: inserting a mold insert into a molding tool and molding a member onto an interior surface within an interior cavity of the mold insert; inserting an elongate medical device body into an interior lumen of the member; undermolding the elongate medical device body directly to the member; and removing the mold insert from the member.

"In Example 2, the method according to Example 1, wherein molding a member onto an interior surface of the mold insert comprises: inserting an elongate rod into the interior cavity of the mold insert; and injection molding an annular-shaped ring onto the interior surface of the mold insert.

"In Example 3, the method according to either Example 1 or 2, wherein the mold insert comprises a sacrificial disk.

"In Example 4, the method according to Example 3, wherein the sacrificial disk comprises a polymeric or metallic material.

"In Example 5, the method according to any of Examples 1-4, wherein undermolding the elongate medical device body directly to the member comprises molding the body onto an interior surface of the member.

"In Example 6, the method according to any of Examples 1-5, wherein undermolding the elongate medical device body directly to the member comprises molding the device body onto an interior surface of the member.

"In Example 7, the method according to any of Examples 1-6, wherein removing the mold insert from the member comprises cutting the mold insert away from the member.

"In Example 8, the method according to any of Examples 1-7, wherein the medical device is an implantable medical electrical lead, and wherein the elongate medical device body is a lead body.

"In Example 9, the method according to any of Examples 1-8, wherein the member comprises a drug-eluting collar.

"In Example 10, a method of manufacturing an implantable medical electrical lead comprises: inserting a mold insert into a molding tool and molding a collar onto an interior surface within an interior cavity of the mold insert; inserting an elongate lead body into an interior lumen of the collar; undermolding the lead body directly to the collar; and removing the mold insert from the collar.

"In Example 11, the method according to Example 10, wherein molding a collar onto an interior surface of the mold insert comprises: inserting an elongate rod into the interior cavity of the mold insert; and injection molding an annular-shaped collar onto the interior surface of the mold insert.

"In Example 12, the method according to either Example 10 or 11, wherein the mold insert comprises a sacrificial disk.

"In Example 13, the method according to Example 12, wherein the sacrificial disk comprises a polymeric or metallic material.

"In Example 14, the method according to any of Examples 10-13, wherein undermolding the lead body directly to the collar comprises injection molding the lead body onto an interior surface of the collar.

"In Example 15, the method according to any of Examples 10-14, wherein undermolding the lead body directly to the collar comprises molding the lead body onto an interior surface of the collar.

"In Example 16, the method according to any of Examples 10-15, wherein removing the mold insert from the collar comprises cutting the mold insert away from the collar.

"In Example 17, a medical electrical lead comprises: a lead body having a proximal section, a distal section, and an outer periphery; and at least one annular-shaped collar undermolded directly to the outer periphery of the lead body.

"In Example 18, the medical electrical lead according to Example 17, wherein the collar is directly coupled to the outer periphery of the lead body via an adhesiveless bond.

"In Example 19, the medical electrical lead according to Example 17, wherein the lead body is molded onto an interior surface of the collar.

"In Example 20, the medical electrical lead according to any of Examples 17-19, wherein the at least one annular-shaped collar comprises a plurality of collars undermolded to the outer periphery of the lead body.

"While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive."

URL and more information on this patent, see: Horrisberger, Benn; Eggert, Joel T.; Morris, Kimberly A.. Steroid Eluting Collar Undermold. U.S. Patent Number 8784714, filed February 6, 2013, and published online on July 22, 2014. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8784714.PN.&OS=PN/8784714RS=PN/8784714

Keywords for this news article include: Cardiac Pacemakers Inc.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2014, NewsRx LLC


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Source: Biotech Week


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