CROSS-REFERENCE TO RELATED APPLICATION(S) This application is a Continuation of U.S. patent application Ser. No. 10/226,374, filed Aug. 21, 2002, which claims the benefit of U.S. Provisional Application No. 60/313,893, filed on Aug. 21, 2001, under 35 U.S.C. 119(e). U.S. patent application Ser. No. 10/226,374 is also a continuation-in-part of U.S. patent application Ser. No. 09/738,401, filed on Dec. 15, 2000 and issued as U.S. Pat. No. 6,643,550, the specifications of which are incorporated by reference herein.
Technical Field The present invention relates generally to connector assemblies for electrophysiological applications. More particularly, it pertains to printed circuit and micro terminal connectors for electrophysiological applications.
BACKGROUND Connector assemblies are used to couple electrophysiological devices with a conductor. For instance, a connector is used to couple a cardiac stimulator system such as a pacemaker, an anti-tachycardia device, a cardioverter or a defibrillator with a lead having an electrode for making contact with a portion of the heart.
When leads with multiple conductors are involved, the conductors are individually, mechanically and electrically coupled with the pulse generator at a proximal end of the multiple conductors. The multiple conductors at the proximal end are electrically insulated from each other to prevent shorts and limit electrical leakage between conductors. However, conventional assemblies are bulky and are relatively large for multi-polar assemblies. Furthermore, conventional assemblies have manufacturing drawbacks, for example, the assembly process is difficult and time consuming.
Accordingly, what is needed is an improved connector assembly. What is further needed is a multipolar connector having a reduced outer diamter.
SUMMARY A connector assembly of an electrophysiologial device is provided herein which overcomes the above problems. The connector assembly includes an insulative elongate tube having an outer periphery and a longitudinal axis. The tube further includes at least one groove within the outer periphery of the elongate tube, and a conductor is disposed in each groove. The assembly further includes a conductive ring member with a projection extending from the internal surface. The projection of the ring member is disposed in the groove and is electrically coupled with the conductor. A terminal pin is disposed within the elongate tube, and insulative material is disposed over the insulative elongate tube adjacent to the conductive ring member.
In another embodiment, a micro terminal is provided that has an outer peripheral surface. The micro terminal includes a tube of insulation, and a first conductor embedded within the tube of insulation, a second conductor embedded within the tube of insulation. A first conductive tab and a second conductive tab extend from the outer peripheral surface to the first conductor and the second conductor, respectively. The tube of insulation has an inner lumen therethrough.
A method is also provided and includes forming a least one groove within an outer periphery of an insulative elongate tube having a longitudinal axis, disposing a conductor in each groove, placing at least one conductive ring member having an internal surface over the outer periphery of the insulative elongate tube, and disposing a projection extending from the internal surface of the conductive ring member within the at least one groove. The method further includes disposing a terminal pin within the insulative elongate tube, and disposing insulative material over the insulative elongate tube adjacent to the conductive ring member.
Several options are as follows. For instance, in one option, the method further includes disposing an insulated conductor in each groove, wherein a portion of insulation of the insulated conductor is removed as the insulated conductor is disposed within the groove. In another option, the method further includes forming a plurality of elongate grooves within the elongate tube, placing a plurality of conductive ring members over the outer periphery of the insulative elongate tube, and positioning the projection of each conductive ring member in a different groove from one another.
In another embodiment, a method includes mechanically and electrically coupling a plurality of conductors with a plurality of rings, positioning the rings and conductors around an inner tube, molding a insulation around the rings, the conductors, and inner tube, mechanically and electrically coupling a coil to a terminal pin, and disposing the coil and the terminal pin through the inner tube.
Several options for the method are as follows. For instance, in one option, the method further includes snap-fittedly coupling the terminal pin with the inner tube. In another option, the method further includes rotating the terminal pin with the inner tube after snap-fittedly coupling the terminal pin with the inner tube. In yet another option, the method further includes stringing an insulative lead body over the coil. Optionally, mechanically and electrically coupling the conductors with the rings includes staking the conductors with the rings.
The terminal connectors described herein allow for significantly smaller terminal design. Furthermore, an insulative non-conductive inner lumen has been provided, which is particularly suited for an open lumen lead, assisting in the prevention of electrical shorts due to fluid entry through the open lumen. In addition, the connectors lend themselves to isodiometric, over-the-wire lead designs, with multiple high and low voltage paths. Furthermore, the connector designs allow for the miniaturization of the connectors while simultaneously providing for multiple conductive pathways suitable for use in various lead designs. This further results in increased reliability and manufacturability of the designs with reduced resistance and increased isolative properties.
These and other embodiments, aspects, advantages, and features of the present invention will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art by reference to the following description of the invention and referenced drawings or by practice of the invention. The aspects, advantages, and features of the invention are realized and attained by means of the instrumentalities, procedures, and combinations particularly pointed out in the appended claims and their equivalents.
BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1 illustrates a side cut-away view of a connector assembly constructed in accordance with one embodiment.
FIG. 2 illustrates an end view of a connector assembly constructed in accordance with one embodiment.
FIG. 3 illustrates a cut-away view of a connector assembly in accordance with another embodiment.
FIG. 4 illustrates an end view of a connector assembly in accordance with one embodiment.
FIG. 5 illustrates a perspective view of a terminal pin in accordance with one embodiment.
FIG. 6 illustrates a perspective view of a conductor in accordance with one embodiment.
FIG. 7 illustrates a perspective view of a ring constructed in accordance with one embodiment.
FIG. 8 illustrates a perspective view of a connector assembly in accordance with one embodiment. pFIG. 9 illustrates a perspective view of a connector terminal constructed in accordance with one embodiment.
FIG. 10 illustrates a portion of a connector assembly in accordance with one embodiment.
FIG. 11 illustrates a side elevational view of a connector assembly constructed in accordance with one embodiment.
FIG. 12 illustrates a side-elevational view of a terminal pin in accordance with one embodiment.
FIG. 13 illustrates an end view of the terminal pin ofFIG. 12.
FIG. 14 illustrates a perspective view of a portion of a terminal pin constructed in accordance with one embodiment.
FIG. 15 illustrates a tube constructed in accordance with one embodiment.
FIG. 16 illustrates a portion of cross-sectional view of the tube inFIG. 15.
FIG. 17 illustrates a cut-away view of a portion of a connector assembly constructed in accordance with one embodiment.
FIG. 18 illustrates a cross-section view of the connector assembly.
FIG. 19 illustrates a cross-section view of the connector assembly.
FIG. 20 illustrates a cross-section view of the connector assembly.
FIG. 21 illustrates a cross-sectional view of a portion of a connector assembly constructed in accordance with one embodiment.
FIG. 22 illustrates a perspective view of a portion of a connector assembly constructed in accordance with one embodiment.
FIG. 23 illustrates a side view of a micro terminal constructed in accordance with one embodiment.
FIG. 24 illustrates a cut-away view ofFIG. 23 constructed in accordance with one embodiment.
FIG. 25 illustrates a side view of the conductive pathways ofFIG. 23 constructed in accordance with one embodiment.
FIG. 26 illustrates a side view of a micro terminal assembly constructed in accordance with one embodiment.
FIG. 27 illustrates a side view of a micro terminal assembly constructed in accordance with one embodiment.
FIG. 28 illustrates a side view of a micro terminal assembly constructed in accordance with one embodiment.
FIG. 29 illustrates a side-elevational view of a pin and ring assembly constructed in accordance with one embodiment.
FIG. 30 illustrates a cross-sectional view of a portion ofFIG. 29.
FIG. 31 illustrates a cross-sectional view of a connector assembly constructed in accordance with one embodiment.
FIG. 32 illustrates a cross-sectional view of a connector assembly constructed in accordance with one embodiment.
FIG. 33 illustrates a cross-sectional view of a connector assembly constructed in accordance with one embodiment.
FIG. 34 illustrates a cross-sectional view of a connector assembly constructed in accordance with one embodiment.
FIG. 35 illustrates a cross-sectional view of a connector assembly constructed in accordance with one embodiment.
FIG. 36 illustrates a cross-section view of a connector assembly constructed in accordance with one embodiment.
DESCRIPTION OF THE EMBODIMENTS In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that other embodiments may be utilized and that structural changes may be made without departing from the scope of the present invention. Therefore, the following detailed description is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims and their equivalents.
A micro terminal connector assembly and a printed circuit connector assembly are provided herein. The micro terminal connector assembly includes small conductive insulated clad wires and/or flexible circuits which are fed through, or embedded within an insulated terminal structure. Variations on these designs include, but are not limited to, inclusion of elements of co-axial or co-radial lead technology. The printed circuit terminal assembly includes conductive and insulation layers in a multiple conductive terminal connector. Each of these in combinations thereof are described in further detail below.
FIGS. 1-4 illustrate examples of a feed-throughterminal110. The feed-throughterminal110 includes electrical connections which are fed from an outer surface of the terminal to the filars through an insulative material. The feed-throughterminal110 includes one or moremetallic tabs112 that serve to connect anouter surface113 of the feed-through terminal110 to conductor of the lead. Thetabs112, in one option, have different lengths. Thetabs112 advantageously provide a small feed-through connection between an outer peripheral surface and the conductor wire. Thetabs112 further allow for more insulation to be disposed between the tabs, as opposed to larger components, such as ring electrodes. This further allows the feed-through terminal110 to have a smaller outer diameter and allows the feed-through terminal110 to be used in high voltage applications.
Aconductor wire114 is electrically coupled with thetabs112, for example, by welding to an inner side of thetabs112. Thewires114 are formed of a conductive material, such as titanium, Pt-Ta, etc, and optionally thewires114 are further individually insulated, in addition to theinsulative material116. The electrically connectedwires114 andtabs112 are molded into aninsulative material116, such as tecothane, through a molding process, such as insert molding. Filars are welded, swaged, or connected using other connection processes to thewires114 which, in one option, are fed through the terminal110. The terminal110 further includes anopen lumen118 therein, which has a wall formed of insulative material. A distal end of thewires114, in one option, is exposed at a distal end of the insulation, as shown inFIG. 3, and conductive wires are attached thereto. It should be noted thatFIGS. 1 and 2 illustrate a co-radial design. In one option, a first conductor and a second conductor are embedded within the tube of insulation, and, optionally, are co-radial with one another. In another option, a first conductor, second, third, and fourth conductor are embedded within the tube of insulation, and are co-radial with one another.
FIGS. 3 and 4 illustrate a coaxial design. For example, a first conductor is radially spaced apart from a second conductor, but they share an axis. In another option, the first conductor is disposed around the second conductor. Thetabs112,112′ ofFIG. 3, are in one option, longitudinally spaced from one another. InFIGS. 3 and 4, three layers ofinsulation116 are incorporated to form theinsulated lumen118, and to insulate thewires114 from one another. It should be further noted that the embodiments shown inFIG. 1 throughFIG. 4 can be combined with the embodiments discussed above and below.
FIGS. 5-8 illustrate one example of a bipolar feed-throughterminal assembly120 and portions thereof, incorporating another embodiment. Theterminal assembly120 includes aterminal pin122. Theterminal pin122 is formed as a single unit of, in one option, insulative material, including anelongate tube123. In another option, theterminal pin122 and theelongate tube123 are separate components coupled together, and optionally are formed of different materials. Theelongate tube123 is formed of insulative material, and includes at least onelongitudinal groove126 therein. In one option, the groove is an elongate longitudinal groove that is parallel to the longitudinal axis of thetube123. Disposed within thelongitudinal groove126 is at least oneconductor124. One example of aconductor124 is a flat elongate conductor, as shown inFIG. 6. Alternatively, other conductors such as wires, coils, or other shapes can be used as well. In another option, conductive material is coated within the groove126 (FIG. 5). Optionally disposed over portions of theconductor124 is additional insulative material, to insulate theconductor124 from other rings or electrically conductive components which are slid thereover. In yet another option, the at least oneconductor124 extends continuously from the terminal pin to anelectrode145 along thelead body148, as shown inFIG. 11.
FIGS. 9 and 10 illustrate another option for a terminal100. The terminal100 includes a plurality ofgrooves102 formed therein. Thegrooves102 are configured to receive aninsulated filar106 therein. The grooves have awidth104 which is slightly smaller than anouter diameter108 of the filar106. Thefilars106 are forced into thegroove102. As thefilars106 are forced into thegroove102, the insulation of the filar106 is removed, given the size of thewidth104 forgroove102 relative to the filar106. In one option, the terminal100 is electrically conductive, and as the insulation of the filar106 is removed, an electrical connection is made between the filar106 and the terminal100. In another option, the terminal100 is formed of non-conductive material, such as polyetheretherketone (PEEK), and the filar106 is electrically coupled with another component, such as a ring, as further described below.
In another option, the terminal100 will consist of multiple strips of metal which are insert molded, into an insulating polymer. Alternatively, the multiple strips of metal are disposed within the insulative polymer in-other manners. Each strip of metal will have thegrooves102 formed or cut therein which forms the insulation displacement connector. The strips are placed in locations to make connections with electrodes or rings, which are electrically coupled with a pulse generator. The insulation displacement terminal can be used with the various embodiments discussed above and below.
Referring toFIGS. 7 and 8, theterminal assembly120 further includes one or more electrically conductive rings128. As shown inFIG. 7, the ring, in one option, has aninterior surface130 from which aprojection132 extends. Theprojection132 of thering128 is received within thegroove126, and is electrically coupled with theconductor124. Theprojection132 electrically couples theconductor124 with the header or other electrical stimulation device.FIG. 7 illustrates an example wheremultiple rings128 are incorporated within theassembly120.
FIGS. 11-13 illustrate alternative embodiments for theterminal pin122. Theelongate tube123 of theterminal pin122 includes a plurality ofgrooves126 within the periphery of theelongate tube123, for example, fourgrooves126 suitable for use in a quad-polar design, shown inFIGS. 11-13. It should be noted that any number of grooves can be used, including a single groove. Alternatively, twogrooves126 are formed in the elongate tube of the terminal pin122 (FIG. 14). At least one conductor124 (FIG. 9) is inserted into each of thegrooves126. Since thegrooves126 are disposed within insulative material for theterminal pin122, each of theconductors124 are electrically isolated from one another, and do not add to the overall outer diameter of theterminal assembly120.
FIG. 11 illustrates aconnector assembly140 formed from aterminal pin122 ofFIGS. 12 and 13. Four rings142, each having an outer diameter of 0.072 inches, are disposed over theterminal pin122, and each is electrically coupled with a conductor disposed within the grooves. An outer diameter of 0.072 inches is achievable due to the construction of theterminal pin122 andring142. The inner diameter of the lumen is electrically isolated from each of the fourrings142, and the fourrings142 are electrically isolated from one another. All of the dielectric paths for this quad-polar configuration were confirmed to be electrically isolated at 1,500 volts AC. Previously, it was not possible to have a bipolar 0.072 inch outer diameter terminal.
FIGS. 15-20 illustrate another embodiment including a printedcircuit terminal150. The printedcircuit terminal150 includes one or more printedcircuits152 thereon. The printedcircuits152 or conductive paths would be printed on a substrate in the form of atube154, where thetube154 is formed of non-conductive material. In another option, thetube154 is formed of electrically conductive material. In another option, a layer ofinsulation156 is disposed over thetube154, and the printedcircuits152 are formed on the layer ofinsulation156. In addition, a layer ofinsulation155 is disposed in a layer over the printedcircuits152. One ormore rings158 are disposed on theassembly150. Anelectrical connection160 would then be formed in between thering158 and the printedcircuits152, where theelectrical connection160 is fed through the insulative material. Each of the individual printedcircuits152 would be electrically isolated from each other by the spacing on theinsulative material156. The printed circuits can be printed on the pin orsubstrate154, alternatively they can be etched or otherwise formed thereon. One example of material for use with the insulative material is KAPTON™ by Dupont. Examples for the conductive material include, but are not limited to, gold, platinum, titanium, copper, or nickel. The connections in between the ring and the printed circuits are formed, for example, by an exposed pad with feed-through wires, a wire through hole, or fingers which extend beyond the flexible circuits, as further discussed above and below.
FIG. 21 illustrates one example of connecting the etched pathways or conductive paths with the terminal byinsulated rings170 which are connected to set screws. Therings170 have insulatingmaterial172 such as polyurethane, silicone dioxide, etc., as the insulative material. Thering170 further includes aconductive portion174, which is formed of conductive material, such as, but not limited to, titanium, gold, or platinum. Asmall section176 of an inside of aring170 is not insulated and can make an active connection with one of the etched conductive pathways (see180,FIG. 22).
FIG. 22 illustrates another example of a printed circuit terminal which includes two etchedpathways180 thereon, including a first pathway181 and asecond pathway183. The first pathway181 and thesecond pathway183 are electrically isolated from one another. It should be noted that additional pathways are contemplated and considered within the scope of this application. The first andsecond pathways181,183 are electrically coupled with afirst ring182 and asecond ring184, respectively.Ring182 is electrically isolated at186 such that it is isolated from thesecond pathway183.Ring182 is electrically coupled at188 with the first pathway181 to form the electrical connection thereto.
FIG. 23 illustrates another variation of a micro terminal concept. A printed circuit terminal pin200 includes apin202 and a layer ofinsulation204 with a plurality ofelectrodes206 therein. Optionally,pin202 is formed of metal material The plurality ofelectrodes206 are electrically isolated from one another within the layer ofinsulation204. The plurality ofelectrodes206 are coupled with conductive pathways180 (FIG. 25) which are etched on the pin, andinsulation204 is disposed over the conductive pathways. The conductive pathways extend between the electrode206 (A, B, C, and D) and the attachment sites, A′, B′, C′, and D′. As shown inFIGS. 26 and 27, the rings, are coupled with their respective electrodes A, B, C, andD. Wires218 are electrically coupled with the attachment sites A′, B′, C′, and D′ and extend along the lead body. As shown inFIG. 28,insulation219 is disposed overinsulation204 and over attachment sites A′, B′, C′, and D′, and the terminal is optionally isodiametric. In another option, no rings are used, and theelectrode206 is used for electrical connection, for example, within a header. In another option, thewires218 are embedded within theinsulation204, such thatadditional insulation219 is not necessary. Still further, in another option, the conductive pathways compriseflexible circuits214 which are disposed within the insulation. Electrical connection between the pin and the device is made by disposingelectrical connectors206 within the insulative material216, where theelectrical connectors206 extend to various depths to reach the individual, respectiveflexible circuits214. Filars of the lead are electrically coupled with a circuit trace of theflexible circuit214. It should be noted that for this embodiment, as well as for above and below discussed embodiments, theflexible circuit214 includes, but is not limited to, electrical paths which are printed, etched, or embedded within or on insulative material and formed into the appropriate configuration. In yet another option, the micro terminal includes alumen207.
FIGS. 30-31 illustrate another option of the printed circuit terminal. The printed circuit terminal includes, for example, asubstrate220, with a terminal ring disposed there over. A layer of insulative material, such as polyimid, i.e., KAPTON™ by Dupont, is disposed over thesubstrate220. The layer of insulative material222 has a thickness, for example, in the range of 0.0002 inches to 0.0010 inches. Disposed over the insulative material222, is a layer for theconductive path224. Thelayer224, in one embodiment, comprises Pt, for the conductive path. Theterminal ring226 is slid over the layers of224 and222 and is joined with the outerconductive path224 with, for example, by conductive adhesive, welding, or other fixation features which would form the electrical connection thereto. One or more filars228 are electrically coupled with the outer conductive layer orpath224.
FIGS. 32-35 show one example of various cross-sectional views of the printed circuit tube for the terminal connector, for example, of a quad-polar . Each of the cross-section views include aninsulative portion232, as well as aconductor234. Each of theconductors234 shown individually inFIGS. 32-35 allow for the multiple rings to be electrically connected with the tube, for example, forming a quad polar relationship thereto, while also maintaining an isodiametric shape for the terminal pin. In addition, theFIGS. 32-35 illustrate how theconductors234 are spaced peripherally from one another, for example, at 0, 90, 180, and 270 degrees around the diameter of the pin. In another option, theconductors234 are longitudinally spaced from one another. It should be noted that other configurations, for example, with more or fewer electrically conductive portions can be configured and arranged on the printed circuit tube. It should be further noted that the embodiments shown inFIGS. 32-35 can be combined with all of the above discussed embodiments.
In another embodiment, a method for forming a connector assembly of an electrophysiological device is provided herein. The method includes insert molding a first flexible circuit within tubular insulating material, and electrically coupling a connector with the first flexible circuit. In one option, the method further includes molding a second flexible circuit within the tubular insulating material, where the second flexible circuit forms a second layer over the first flexible circuit. In another option, the method includes electrically coupling a second connector with the second flexible circuit, and the second connector has a different depth within the tubular insulating material than the first connector.
A method is also provided and includes forming a least one groove within an outer periphery of an insulative elongate tube having a longitudinal axis, disposing a conductor in each groove, placing at least one conductive ring member having an internal surface over the outer periphery of the insulative elongate tube, and disposing a projection extending from the internal surface of the conductive ring member within the at least one groove. The method further includes disposing a terminal pin within the insulative elongate tube, and disposing insulative material over the insulative elongate tube adjacent to the conductive ring member.
Several options are as follows. For instance, in one option, the method further includes disposing an insulated conductor in each groove, wherein a portion of insulation of the insulated conductor is removed as the insulated conductor is disposed within the groove. In another option, the method further includes forming a plurality of elongate grooves within the elongate tube, placing a plurality of conductive ring members over the outer periphery of the insulative elongate tube, and positioning the projection of each conductive ring member in a different groove from one another.
In another embodiment, referring toFIG. 36, a method includes mechanically and electrically coupling a plurality ofconductors250 with a plurality ofrings252, for example, by staking theconductors250 with therings252. The method further includes positioning therings252 andconductors250 around aninner tube254, molding aninsulation258 around therings252, theconductors250, andinner tube254, for example by injecting an insulative material to fix the components and place and complete the assembly except for the pin component. The rings, cables, and inner tube can be provided in a single overmolded assembly. The method further includes mechanically and electrically coupling a coil to aterminal pin256, and disposing the coil and the terminal pin through theinner tube254.
Several options for the method are as follows. For instance, in one option, the method further includes snap-fittedly coupling the terminal pin with the inner tube. In yet another option, the method further includes stringing an insulative lead body over the continuously extending conductors. Optionally, mechanically and electrically coupling the conductors with the rings includes coupling continuously extending conductors with the rings, and coupling the continuously extending conductors with an electrode (seeFIG. 11). The method allows for achieving an outer diameter of approximately 3 mm, and in one option, is designed for a simple snap-assembly where latches of the pin and tube engage one another. Other types of snap-fit designs are available as well. The molding operation distinctly locates components consistently, and reliably isolates the conductors from one another by providing redundant insulation between components.
Advantageously, the above-described terminal connectors allow for significantly smaller terminal design. Furthermore, an insulative non-conductive inner lumen has been provided, which is particularly suited for an open lumen lead, assisting in the prevention of electrical shorts due to fluid entry through the open lumen. In addition, the above-described connectors lend themselves to isodiametric, over-the-wire lead designs, with multiple high and low voltage paths. Furthermore, the above connector designs allow for the miniaturization of the connectors while simultaneously providing for multiple conductive pathways suitable for use in various lead designs. This further results in increased reliability and manufacturability of the designs with reduced resistance and increased insulative properties.
It is to be understood that the above description is intended to be illustrative, and not restrictive. Many other embodiments will be apparent to those of skill in the art upon reading and understanding the above description. It should be noted that embodiments discussed in different portions of the description or referred to in different drawings can be combined to form additional embodiments of the present invention. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.