US20090177070A1 - Catheter tip electrode assembly and method for fabricating same - Google Patents
Catheter tip electrode assembly and method for fabricating same Download PDFInfo
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- US20090177070A1 US20090177070A1 US12/409,268 US40926809A US2009177070A1 US 20090177070 A1 US20090177070 A1 US 20090177070A1 US 40926809 A US40926809 A US 40926809A US 2009177070 A1 US2009177070 A1 US 2009177070A1
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- electrode
- electrodes
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- aperture
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
- A61B5/053—Measuring electrical impedance or conductance of a portion of the body
- A61B5/0536—Impedance imaging, e.g. by tomography
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
- A61B5/053—Measuring electrical impedance or conductance of a portion of the body
- A61B5/0538—Measuring electrical impedance or conductance of a portion of the body invasively, e.g. using a catheter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00053—Mechanical features of the instrument of device
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
- A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
- A61B5/283—Invasive
- A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49002—Electrical device making
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49002—Electrical device making
- Y10T29/49117—Conductor or circuit manufacturing
Abstract
An electrode assembly for a sensor catheter tip includes a first electrode and a second electrode each having a central axis. The two electrodes are axially aligned and spaced apart along the axis. Each of the first and second electrodes comprises a contact aperture spaced from the center axis, and a contact. element positioned within each of the contact apertures. The center axis of each of the first and second electrodes is substantially aligned, and the contact elements corresponding to each of the first and second electrodes are offset, thereby providing staggered contact points for each respective electrode.
Description
- This application claims priority to and is a continuation of U.S. Application Ser. No. 11/435,155, filed May 16, 2006, entitled “CATHETER TIP ELECTRODE ASSEMBLY AND METHOD FOR FABRICATING SAME”, which is a divisional of U.S. application Ser. No. 10/679,568, filed Oct. 6, 2003, entitled “CATHETER TIP ELECTRODE ASSEMBLY AND METHOD FOR FABRICATING SAME”, the subject matter of both of which are herein incorporated by reference in their entirety.
- This invention relates generally to manufacturing of medical instruments, and, more specifically, to the manufacture of a catheter electrode assembly for an impedance spectroscopy system.
- Impedance spectroscopy has been used to detect ischemia (a condition of inadequate blood flow and oxygen delivery to a given tissue) in biological tissues using different instrumental methods. Impedance spectroscopy differs from other impedance measurements (which have long been used for a variety of biomedical applications) in that it involves multiple measurements over a range of frequencies that as a whole contain significantly more information of the structural and electrical properties of the sample.
- At least one known impedance spectroscopy system for monitoring tissue damage in hollow viscous organs includes a sensor catheter and an impedance spectrometer for electrically driving the catheter to obtain a complex impedance spectrum of tissue proximate the catheter. The catheter is configured to be inserted into any hollow viscous organ, and the catheter includes four Ag/AgCl electrodes positioned on an end tip of the catheter. The electrodes are coaxially spaced apart a short distance from one another, and the outer two electrodes inject current into the tissue, while the inner two electrodes measure the resulting voltage. Leads, electrically connected to the electrodes, extend along the wall of the catheter tubing or in a lumen portion of the tubing, and terminate at an interface plug suitable for electrical and mechanical connection to the impedance spectrometer. Once the catheter is in place in one of a patient's hollow viscous organs, the impedance spectrometer causes the electrodes in the tip of the catheter to inject a current into the mucosal tissue at different frequencies, allowing for the measurement of the tissue's complex impedance spectrum. Analysis of the spectrum determines the extent to which the tissue is damaged. See, for example, U.S. Patent Application Publication US 2002/0013537.
- The construction of the catheter tip assembly for such a system has proven difficult in a number of aspects. The catheter tip assembly is, for example, typically inserted into the throat or nasal passage of a patient and into a gastrointestinal organ, and the therefore must be of a relatively small size and have a uniform, high quality surface finish. The tip assembly, however. includes a relatively large number of component parts which must be assembled and interconnected, including a tip, four electrodes, dielectric spacer elements between the electrodes, and. leads attached to each electrode, which can make a uniform surface finish difficult to achieve. Additionally, assembly of the many component parts is cumbersome, and separately connecting the electrical leads to the spaced electrodes in a reliable manner is difficult. Managing the wire leads in the constrained internal space of the assembly, which entails threading the wires through the dielectric spacer elements, is especially difficult. These and other difficulties not only complicate the tip assembly time and increase manufacturing costs, but may negatively affect the performance and reliability of the impedance spectroscopy system when treating critically ill patients.
- In one embodiment, an electrode assembly for a sensor catheter tip is provided. The assembly includes a first electrode and a second electrode each having a central axis. The two electrodes are axially aligned and spaced apart along the axis. Each of the first and second electrodes comprises a contact aperture spaced from the center axis, and a contact element positioned within each of the contact apertures. The center axis of each of the first and second electrodes is substantially aligned, and the contact elements corresponding to each of the first and second electrodes are offset, thereby providing staggered contact points for each respective electrode.
- Optionally, the contact elements, of the first and second electrode are offset approximately 90 degrees from one another. Each of the first and second electrodes comprise a disk defined by multiple regions, the contact element positioned in one of the regions, the other of the regions comprising a lead aperture extending therethrough. Each of the contact elements have an axial length which is different for each of the contact elements, and each contact element comprises a tail portion configured for soldering or crimping. An overmolded dielectric spacer element is disposed between the first and second electrodes, and the dielectric spacer element extends at least partially through one of the electrodes.
- In another embodiment, a catheter tip assembly for an impedance spectroscopy system is provided. The assembly comprises a rounded dielectric tip, and a first electrode disk adjacent the tip which comprises a body having a contact aperture therethrough. A second electrode disk is axially spaced from the first electrode disk, and the second electrode comprises a body having a contact aperture therethrough. The second electrode disk is rotated relative to the first electrode disk about a longitudinal axis so that the contact apertures are circumferentially offset from one another.
- In another embodiment, a method of fabricating a catheter tip for an impedance spectroscopy system is provided. The catheter tip includes a plurality of electrodes with a dielectric material positioned between adjacent electrodes. Each of the electrodes includes a contact aperture and at least one lead aperture, and the electrodes are electrically connected to respective contacts. The method comprises positioning one of the contacts in contact with each of the electrodes via the respective contact apertures, stacking the electrodes and attached contacts, and rotating each electrode relative to the adjacent electrode in the stack so that the contacts are offset from one another in the stack.
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FIG. 1 is a plan view of an exemplary tip assembly formed in accordance with an exemplary embodiment of the present invention and adapted for use in a sensor catheter assembly for an impedance spectroscopy system. -
FIG. 2 is a top plan view of an exemplary electrode disk for the tip assembly shown inFIG. 1 . -
FIG. 3 is partial cross sectional plan view of an exemplary electrode contact for the tip assembly shown inFIG. 1 . -
FIG. 4 is a top plan view in a first stacked position of an electrode assembly for the tip assembly shown inFIG. 1 . -
FIG. 5 is a top plan view of the electrode assembly in a second stacked position. -
FIG. 6 is a top plan view of the electrode assembly in a third stacked position. -
FIG. 7 is a top plan view of the electrode assembly in a fourth position. -
FIG. 8 illustrates the electrode assembly at another stage of manufacture. -
FIG. 9 illustrates the electrode assembly at a further stage of manufacture. -
FIG. 10 is a partial cross sectional view of the catheter tip assembly at a final stage of manufacture. -
FIG. 11 is a schematic view of a completed catheter tip assembly. -
FIG. 12 is a sectional view of an exemplary sump tube for the tip assembly shown inFIGS. 1 and 11 . -
FIG. 13 is a perspective view of an exemplary electrode disk formed in accordance with another exemplary embodiment of the present invention. -
FIG. 14 is a perspective view of a dielectric spacer element for use with the electrode disk shown inFIG. 13 . -
FIG. 15 is a perspective view of an exemplary contact clip for use with the electrode and dielectric disk shown inFIGS. 13 and 14 . -
FIG. 16 is an exploded view of an electrode assembly at a first stage of manufacture. -
FIG. 17 is an exploded view of the electrode assembly shown inFIG. 16 at a second stage of manufacture. -
FIG. 18 is a perspective view of the electrode assembly shown inFIG. 16 at a third stage of manufacture. -
FIG. 19 illustrates an exemplary lead wire and contact for the electrode assembly shown inFIG. 18 . -
FIG. 20 is an assembly view of the electrode assembly shown inFIGS. 16-18 at a fourth stage of manufacture. -
FIG. 21 is a perspective view of a completed electrode assembly. -
FIG. 1 illustrates atip assembly 100 for a sensor catheter of an impedance spectroscopy system. Thetip assembly 100 comprises a hemispherically roundedtip 102. anelectrode assembly 104 extending from thetip 102, aconnector portion 106 extending from theelectrode assembly 104 opposite thetip 102, and acoupler portion 108 extending from theconnector portion 106. As described in detail below, in a preferred embodiment, thetip assembly 100 is fabricated in a series of molding operations which ensures reliable electrical interconnection of theelectrode assembly 104 with a relatively few number of parts in comparison to known catheter tip assemblies. Performance and reliability of thetip assembly 100 may therefore be provided at a reduced cost. - In an exemplary embodiment, the
electrode assembly 104 of thetip assembly 100 includes four generallycylindrical electrodes FIG. 1 ) to the impedance spectroscopy system. Stacking and rotating of the electrodes, 116 through 122, as described below, provides staggered or offset contact points (not shown inFIG. 1 ) for eachlead wire 110 within thetip assembly 100. The staggered contact points facilitate direct connection and routing of electrode contact elements (not shown inFIG. 1 ) through theelectrode assembly 104, as well as convenient attachment of thelead wires 110 for eachrespective electrode 116 through 122 as described below. - The
lead wires 110 extend from anend 112 of thecoupler portion 108, and aflexible sump tube 114 is provided which can be inserted, together with thetip assembly 100, in any hollow viscous organ. Thesump tube 114 is sealingly engaged to thetip assembly 100 over thecoupler portion 108 such that thecoupler portion 108 andlead wires 110 extend through a lumen (not shown inFIG. 1 ) of thesump tube 114 to an electrical multi-channel connector (not shown) that can be plugged into the impedance spectrometer portion (not shown) of a known impedance spectroscopy system. - The
electrodes 116 through 122 of theelectrode assembly 104 function as ionic-current-to-electronic-current transducers, such as Ag/AgCl electrodes. It is appreciated, however, that other types of suitable electrodes could be used without departing from the spirit and scope of the invention. Theelectrodes 116 through 122 are formed substantially identically to one another, and theelectrodes 116 through 122 are spaced equally apart from one another along theelectrode assembly 104, and are separated bydielectric spacer elements tip 102 and theelectrodes 116 through 122 are about the same as an outer diameter of thespacer elements 124 through 128 and further are about the same as the outer diameter of thesump tube 114 to ensure that a substantially continuous outer surface of the tip assembly is formed. Thetip assembly 100 interfaces with thesump tube 114 at ashoulder 130 of theconnector portion 106 at anend 132 of the sump tube to form a contiguous outer surface of thetip assembly 100 and thetube 114 which facilitates insertion of thetip assembly 100 andsump tube 114 into a patient with minimal discomfort. - A signal processing device associated with the spectroscopy system, such as an appropriately-programmed general purpose computer, processes a complex impedance spectrum sensed by the
electrode assembly 104 to detect tissue damage in a patient. To monitor mucosal damage, a catheter including thetip assembly 100 is placed in one of a patient's hollow viscous organs, and current is injected by two of theelectrodes electrodes - While four
electrodes 116 through 122 are illustrated in the exemplary embodiment, it is appreciated that only two of the four electrodes may be provided in an alternative embodiment without departing from the scope of the present invention. In a two electrode embodiment, each electrode would be used for both current source and voltage measurement. Additionally, in a two electrode embodiment, only one of thedielectric spacer elements 124 through 128 would be employed in between the two electrodes. It is further contemplated that more than four electrodes may be provided in still another embodiment. -
FIG. 2 is a top plan view of anexemplary electrode disk 140 which may be employed in the electrode assembly 104 (shown inFIG. 1 ) of the tip assembly 100 (shown inFIG. 1 ) as any of theelectrodes FIG. 1 ). Thedisk 140 includes abody 142 having acenter 144 corresponding to a central axis of the disk, two radially extendingspokes center 144, and a substantially cylindricalouter surface 150. Thebody 142 further includes substantially flat and parallel end planes or surfaces 152 (only one of which is visible inFIG. 2 ) which are perpendicular to the central axis. Thespokes centerlines 147 and 149 through each of thespokes center 144 of thedisk 140 and define four substantially equal regions or quadrants of thedisk 140. Acircular contact aperture 154 extends between the opposite end planes ofsurfaces 152 in one of the quadrants, and the remaining three quadrants each include alead aperture 156. As illustrated inFIG. 2 , eachlead aperture 156 is significantly larger than thecontact aperture 154, and eachlead aperture 156 includes acurved edge 158 extending parallel to the cylindricalouter surface 150 and substantiallystraight edges 160 extending substantially parallel to one of thespokes lead apertures 156 therefore has a rounded triangular shape or profile in an exemplary embodiment. It is recognized, however, that a variety of shapes oflead apertures 156 may be employed in further and/or alternative embodiments of the invention. - In use, and as further described below, a
contact element 170 is positioned in thecontact aperture 154. The contact element is attached to a respective wire lead 110 (shown inFIG. 1 ) as the tip assembly 100 (shown inFIG. 1 ) is manufactured. Thelead apertures 156 facilitate passage of the contact element through the electrode assembly 104 (shown inFIG. 1 ) and further facilitates molding of thedielectric spacer elements FIG. 1 ) during fabrication of thetip assembly 100. -
FIG. 3 is partial cross sectional plan view of an exemplaryelectrode contact element 170 in the form of an elongated contact pin for the tip assembly 100 (shown inFIG. 1 ). In an exemplary embodiment, thecontact pin 170 includes abody 172 having a taperedleading end 174, a substantiallycylindrical shaft portion 176, and a hollow, cup liketail portion 178 forming apassage 180 which receives an end (not shown) of one of the lead wires 110 (shown inFIG. 1 ). In one embodiment, thetail portion 178 and thepassage 180 form a solder cup for electrically connecting stripped conductors of alead wire 110 via a known soldering process. It is appreciated, however, that other electrical connection techniques may be employed in lieu of soldering to establish an electrical connection between thecontact pin 170 and alead wire 110 in alternative embodiments. - The
electrode assembly 104 according to the invention includes onecontact pin 170 for each electrode in the assembly, and hence in the illustrated embodiment, theelectrode assembly 104 includes four separate contact pins 170, and eachcontact pin 170 corresponds to one of theelectrodes contact pins 170 would be employed. - The
shaft portion 176 of eachcontact pin 170 is dimensioned for press fitting acontact pin 170 into the contact aperture 154 (shown inFIG. 2 ) of eachelectrode 116 through 122 (shown inFIG. 1 ), and hence in the illustrated embodiment, onecontact pin 170 is press fit into thecontact aperture 154 of eachelectrode 116 through 122. Eachcontact pin 170 has an axial length Lx measured from a tip of theleading end 174 to anend 182 of thetail portion 178, and Lx corresponds to an axial distance from a connection point 220 (shown inFIG. 11 ) in the connector portion 106 (shown inFIG. 11 ) of thetip assembly 100 to therespective electrode 116 through 122. That is, Lx varies depending upon whichelectrode contact pin 170 engages in theelectrode assembly 104. Referring, for example, toFIG. 11 , from the shortest contact length Lx to the longest contact length Lx in a four electrode embodiment, thefirst electrode 122 closest to theconnection point 220 has a length L1, the nextclosest electrode 120 has a length L2, the nextclosest electrode 118 has a length L3, and thefarthest electrode 116 has a length L4. ComparingFIG. 11 andFIG. 3 , it may be seen that the difference in length Lx of the contact pins 170 is principally the different length of theshaft portions 176 of the contact pins 170. - By engaging the contact pins 170 to the
contact apertures 154 of theelectrodes 116 through 122, and further by stacking and rotating the electrodes as described below, reliable electrical connection may be established between therespective electrodes 116 through 122, the contact pins 170 and the lead wires 110 (shown inFIG. 1 ). -
FIGS. 4-7 illustrate a stacking and rotating procedure for fabricating the electrode assembly 104 (shown inFIG. 1 ).FIG. 4 shows theelectrode 116 having a pressfit contact pin 170 engaged tocontact aperture 154. Thelead openings 156 of theelectrode 116 are open and clear of any contact pins 170. -
FIG. 5 illustrates theelectrode 116 and theelectrode 118 in a stacked relation, with theelectrode 118 situated underneath and substantially axially aligned with theelectrode 116. That is, the centers 144 (shown inFIG. 2 ) of each of theelectrodes electrode 118 is rotated 90 degrees in the direction of arrow A about the center axis relative to theelectrode 116. As such, thecontact aperture 154 of theelectrode 118 is located beneath one of thelead apertures 156 of theelectrode 116, and theleading end 174 of acontact pin 170 engaged to theelectrode 118 is positioned generally 90 degrees about the center axis from thecontact aperture 154 of theelectrode 116. The lead apertures 156 on the lower portion of theelectrodes FIG. 5 are substantially aligned with one another, and thecontact pin 170 coupled to theelectrode 116 extends through the remaining lead aperture 156 (not visible inFIG. 5 ) positioned underneath thecontact aperture 154 of theelectrode 116. -
FIG. 6 illustrates theelectrode 116, theelectrode 118, and theelectrode 120 in a stacked relation, with theelectrode 120 situated underneath and substantially axially aligned with theelectrodes FIG. 2 ) of each of theelectrodes electrode 120 is rotated 90 degrees from theelectrode 118 in the direction of arrow A about the center axis of theelectrodes contact aperture 154 of theelectrode 120 is located beneath one of thelead apertures 156 of theelectrode 118, and theleading end 174 of acontact pin 170 engaged to theelectrode 118 is positioned generally 90 degrees about the center axis from thecontact aperture 154 of theelectrode 118. The lead apertures 156 on the lower left hand portion of theelectrodes FIG. 6 are substantially aligned with one another. Thecontact pin 170 coupled to theelectrode 116 extends through lead apertures 156 (not visible inFIG. 6 ) of each of theelectrodes contact aperture 154 of theelectrode 116. Thecontact pin 170 coupled to theelectrode 118 extends through one of the lead apertures 156 (not visible inFIG. 6 ) of theelectrode 120 positioned underneath thecontact aperture 154 of theelectrode 118. -
FIG. 7 illustrates theelectrodes electrode 122 situated underneath and substantially aligned with theelectrodes FIG. 2 ) of each of theelectrodes electrode 122 is rotated 90 degrees from theelectrode 120 in the direction of arrow A about the center axis of theelectrodes contact aperture 154 of theelectrode 122 is located beneath one of thelead apertures 156 of theelectrode 120, and theleading end 174 of acontact pin 170 engaged to theelectrode 120 is positioned generally 90 degrees about the center axis from thecontact aperture 154 of theelectrode 120. Thecontact pin 170 coupled to theelectrode 116 extends through lead apertures 156 (not visible inFIG. 7 ) of each of theelectrodes contact aperture 154 of theelectrode 116. Thecontact pin 170 coupled to theelectrode 118 extends through the lead apertures 156 (not visible inFIG. 7 ) of theelectrodes contact aperture 154 of theelectrode 118. Thecontact pin 170 coupled to theelectrode 120 extends through the lead aperture 156 (not visible inFIG. 7 ) of theelectrode 122 positioned underneath thecontact aperture 154 of theelectrode 120. - In the stacked orientation of
FIG. 7 , theelectrode assembly 104 may be secured together in a molding process. The contact pins 170 of therespective electrodes 116 through 122 are positioned 90 degrees about the center axis from one another in the stack, and the contact pins 170 extend through thelead apertures 156 of subsequent electrodes in the stack. Thestacked electrodes 116 through 122 and associated contact pins 170 may be placed in a mold (not shown) and the stack is overmolded with a dielectric material according to a known process to form the tip 102 (shown inFIG. 1 ) and thespacer elements FIG. 1 ). In one embodiment, theouter surfaces 150 of theelectrodes 116 through 122 are secured in the mold within pockets or channels in the mold, and the dielectric material flows through thelead apertures 156 and between therespective electrodes integral electrode assembly 104 wherein thedielectric spacer elements stacked electrodes 116 through 122 and the associated contact pins 170. -
FIG. 8 illustrates theelectrode assembly 104 at a stage of manufacture just after overmolding of the stacked and rotatedelectrodes 116 through 122. Theouter surface 150 of each of theelectrodes 116 through 122 extends beyond anouter surface 230 of the moldedtip 102 and thedielectric spacer elements 124 through 128 due to the configuration of the mold. Therounded tip 102 is molded on one end of theelectrode assembly 104 adjacent theelectrode 116, and thetail portions 178 of the contact pins 170 extend from anopposite end 232 of theelectrode assembly 104 proximate theelectrode 122. Therespective tail portions 178 of each of the contact pins 170 connected to each of theelectrodes FIG. 1 ) to the contact pins 170. -
FIG. 9 illustrates theelectrode assembly 104 at a subsequent stage of manufacture wherein theouter surfaces 150 of theelectrodes outer surfaces 150 of the electrodes, together with theouter surfaces 230 of thedielectric spacer elements integral electrode assembly 104. The lead wires 110 (shown inFIG. 1 ) are connected to each of the exposedrespective tail portions 178 of the contact pins 170 by, for example, a known soldering process. - After the
lead wires 110 are attached to the contact pins 170, theelectrode assembly 104 is placed in a mold, and the connector portion 106 (shown inFIG. 1 ) and the coupler portion 108 (also shown inFIG. 1 ) are overmolded to form the tip assembly 100 (shown inFIG. 1 ). -
FIG. 10 is a partial cross sectional view of thetip assembly 100 after theelectrode assembly 104 is overmolded to form theconnector portion 106 which encases the soldered contact pins 170 and thecoupler portion 108 which extends over thelead wires 110. Thecoupler portion 108 extends from ashoulder 130 at the end of theconnector portion 106 which forms a step between theouter surface 230 of theelectrode assembly 104 and anouter surface 240 of thecoupler portion 108. Thelead wires 110 are gathered together and extend through acentral passage 242 in thecoupler portion 108. Thepassage 242 is dimensioned to receive thewires 110 corresponding to each of the contact pins 170 in theelectrode assembly 104. -
FIG. 11 is a schematic view of a completedtip assembly 100. Each of theelectrodes 116 through 122 are electrically connected to one of the respective contact pins 170 within therespective contact apertures 154 and extending for axial lengths L1 through L4 in theelectrode assembly 104. Thedielectric spacer elements tip 102 are molded over theelectrodes 118 through 122. The wire leads 110 are coupled to therespective tail portions 178 of each of the contact pins 170, and theconnector portion 106 and thecoupler portion 108 are molded over the contact points 220 and thelead wires 110 to complete theassembly 100. - Summarizing, the
assembly 100 is fabricated by pressing fitting the contact pins 170 to theelectrodes 116 through 122; stacking and rotating theelectrodes 116 through 122 and the associated contact pins 170 with the contact pins 170 axially offset from one another and extending through lead apertures 156 (shown in FIGS. 2 and 4-7) of subsequent electrodes in the stack; overmolding the stacked electrodes to form thetip 102 and thedielectric spacer elements FIG. 8 ; machining the electrodes to form a smooth and continuous outer surface on theelectrode assembly 104 as shown inFIG. 9 ; connecting thelead wires 110 to thetail portions 178 of the electrode assembly; and overmolding theelectrode assembly 104 and the lead wires to form theconnector portion 106 and thecoupler portion 108. Once completed, thetip assembly 100 may be tested to ensure proper operation of theelectrode assembly 104 before use. - The above described
tip assembly 100 and method of fabrication provides a number of advantages over known tip assembly constructions. For example, the staged molding of the tip assembly to form thedielectric spacer elements coupler portions electrodes 116 through 122 and providing the contact pins 170 avoids difficulties in connecting the electrodes to thelead wires 110, thereby reducing assembly time and costs. Reliable and consistent electrical connections for theelectrodes 116 through 122 are therefore achieved in a relatively low cost and straightforward manufacturing process. -
FIG. 12 is a sectional view of anexemplary sump tube 114 for the tip assembly 100 (shown inFIG. 11 ). In one embodiment, thesump tube 114 includes a cylindricalouter surface 250 having an outer diameter substantially equal to an outer diameter of the electrode assembly 104 (shown inFIG. 11 ), a first passage orlumen 252 extending through thetube 114, and asecond lumen 254 extending through thetube 114. Thefirst lumen 252 is substantially a cylindrical passage having a complementary shape to the coupler portion 108 (shown inFIG. 11 ) of thetip assembly 100 and dimensioned to receive thecoupler portion 108 therein. Thelumen 252 is inserted over thecoupler portion 108 and thetube 114 is sealed to thecoupler portion 108 at one end thereof. Thelead wires 110 extend through thelumen 252 and are connected to external equipment on an opposite end for transmitting and receiving signals to and from the electrodes. It is recognized that thecoupler portion 108 and thelumen 252 may be formed into a variety of alternative complementary shapes in lieu of a cylindrical shape in alternative embodiments. - The
second lumen 254, sometimes referred to as a primary lumen, is provided for feeding/sump tube purposes or as another type of life support. When placed in fluid communication with an organ, theprimary lumen 254 may be used, for example, for passage of food to a patient, for drainage of fluid from the patient, or other purposes. It is appreciated that theprimary lumen 254 may have a variety of shapes in various embodiments. -
FIG. 13 is a perspective view of anexemplary electrode disk 300 formed in accordance with another exemplary embodiment of the present invention and which may be used to construct a tip assembly (not shown inFIG. 12 ) according to another method. Theelectrode 300 includes acentral aperture 302, four substantially equally spacedcontact apertures 304 positioned around thecentral aperture 302, and onepositioning aperture 306 located between two of thecontact apertures 304. Theelectrode 300 functions as an ionic-current-to-electronic-current transducer, such as an Ag/AgCl electrode, although it is appreciated that another type of suitable electrode could be used without departing from the spirit and scope of the invention. -
FIG. 14 is a perspective view of adielectric spacer element 320. Thespacer element 320 includes acentral aperture 322, four substantially equally spacedcontact apertures 324 positioned around thecentral aperture 322, and one positioning protrusion or peg 326 located between two of thecontact apertures 324. Thepeg 326 is dimensioned for press fit insertion into the positioning aperture 306 (shown inFIG. 13 ) of theelectrode 300 to mate theelectrode 300 to thespacer element 320. Thespacer element 320 is fabricated from a dielectric material according to known processes and techniques. -
FIG. 15 is a perspective view of an exemplary contact element in the form of acontact clip 340 including arim 342 and a number ofinclined contact fingers 344 extending from therim 342 and converging toward one another. Therim 342 is dimensioned for press fit insertion into one of thecontact apertures 304 of the electrode 300 (shown inFIG. 13 ) with thecontact fingers 344 extending from one side of theelectrode 300. Thecontact clip 340 may be fabricated from a conductive material according to known techniques. -
FIG. 16 is an exploded view of anelectrode assembly 350 at a first stage of manufacture wherein a number ofelectrodes 300 are stacked withdielectric spacer elements 320 sandwiched between the electrodes. Apositioning peg 326 of aspacer 320 is inserted into thepositioning aperture 306 of theadjacent electrode 300, and each of theelectrodes 300 is rotated about 90 degrees about the center axis from theadjacent electrode 300 in the stack. Therespective spacer elements 320 are accordingly rotated so that thepegs 326 may be engaged to therespective electrodes 300. Thecontact apertures electrodes 300 and thespacer elements 320 are substantially aligned with the adjacent electrodes/spacer elements to form contact passages through the stack. Thecentral apertures electrodes 300 and thespacer elements 320 are substantially aligned with the adjacent electrodes/spacer elements to form a continuous center passage through the stack. - A contact clip 340 (shown in
FIG. 15 ) is inserted into each of theelectrodes 300 in one of thecontact apertures 304 such that, when the electrodes are stacked and rotated, the contact clips 340 are positioned 90 degrees from one another within the stack. Thecontact fingers 344 of theclips 340 extend through thecontact apertures 324 ofadjacent spacer elements 320. -
FIG. 17 is a view of theelectrode assembly 350 at a second stage of manufacture wherein a separately formedtip 360 is provided having arounded head 362, acentral post 364 extending therefrom, and apositioning peg 366. Thepost 364 is inserted through thecentral apertures electrodes 300 and thespacer elements 320, and thepeg 366 is inserted into thepositioning aperture 306 in theadjacent electrode 300. Once thetip 360 is coupled to theelectrode assembly 350, theelectrode assembly 350 may be placed in a mold and overmolded to form a connector portion (not shown inFIG. 17 ) on an end of theelectrode assembly 350 opposite thetip 360. -
FIG. 18 is a perspective view of atip assembly 370 after theelectrode assembly 350 is molded to form aconnector portion 372. The connector portion includescontact apertures 374 extending through theconnector portion 372 and aligning with the contact apertures of theelectrode assembly 350. The post 364 (shown inFIG. 17 ) of thetip 360 is in intimate contact with and secured to the connector-portion 374 to hold the tip assembly together. -
FIG. 19 illustrates an exemplary lead wire andcontact assembly 380 including alead wire 382 and acontact 384 which is crimped to the conductors of thewire 384. Thecontacts 384 are shaped for engagement with the fingers 344 (shown inFIG. 15 ) of the contact clips 340 (shown inFIG. 15 ). -
FIG. 20 is a perspective view of a number of wire andcontact assemblies 380 extended through alumen 390 of aflexible tube 392, and thecontacts 384 inserted into the contact apertures of thetip assembly 370. Thewires 382 are inserted into thetip assembly 370 until therespective contact 384 engages one of the contact clips 340 in theelectrode assembly 350. -
FIG. 21 illustrates a completedcatheter assembly 400 including thetip assembly 370 and thetube 392 coupled thereto. Asecond lumen 400 is provided in the tube as desired. Thelead wires 382 extend through thefirst lumen 390 of thetube 392 and to external equipment to transmit and receive signals from theelectrodes 300. - Summarizing, the
assembly 370 is fabricated by pressing fitting the contact clips 340 to theelectrodes 300; rotating theelectrodes 300 and the associated contact clips 340 with the contact clips 340 offset from one another and extending through thecontact apertures 324 of thespacer elements 320 in the stack; stacking theelectrodes 300 and thespacer elements 320 such that thedielectric spacer elements 320 are sandwiched between theelectrodes 300; inserting atip 360 into the stacked electrodes; overmolding the stacked electrodes to form theconnector portion 372 and to secure the stack to thetip 360; crimping thecontacts 384 to thelead wires 382; and inserting thelead wires 382 into the contact apertures in the stack until the contacts engage the contact clips 340. Once completed, thetip assembly 370 may be tested to ensure proper operation of theelectrode assembly 350 before use. - The above described
tip assembly 370 and method of fabrication provides a number of advantages over known tip assembly constructions. For example, the substantially identically formed electrodes and spacer elements may be manufactured in bulk at a relatively low cost. Rotating the electrodes and providing the contact clips avoids difficulties in connecting the electrodes to the lead wires, and engaging the crimped contacts to the contact clips is easily accomplished. Reliable and consistent electrical connections for the electrodes are therefore achieved in a relatively low cost and straightforward manufacturing process. - While the invention has been described in terms of various specific embodiments, those skilled in the art will recognize that the invention can be practiced with modification within the spirit and scope of the claims.
Claims (21)
1.-16. (canceled)
17. A method of fabricating a catheter tip for an impedance spectroscopy system, the catheter tip including a plurality of electrodes with a dielectric material extending between adjacent electrodes, each of the electrodes including a contact aperture and at least one lead aperture, the electrodes electrically connected to respective contacts, said method comprising:
press fitting one of the contacts to each of the electrodes via the respective contact apertures;
stacking the electrodes and attached contacts; and
rotating each electrode relative to the adjacent electrode in the stack so that the contacts are staggered from one another in the stack.
18. A method in accordance with claim 17 wherein the contacts have different lengths and each of the electrodes has a lead opening, said method further comprising arranging the electrodes such that each respective contact in the stack of electrodes extends through each of the respective lead openings of electrodes having a shorter contact in the stack.
19. A method in accordance with claim 17 further comprising injection molding the electrodes with a dielectric material, thereby forming dielectric spacer elements between the electrodes.
20. A method in accordance with claim 17 further comprising stacking dielectric spacer elements between each of the electrodes such that a positioning peg of each spacer element is received within at least one adjacent electrode.
21. A method in accordance with claim 18 further comprising attaching a lead to each respective contact.
22. A method in accordance with claim 18 , the assembly including a tip adjacent a first stacked electrode, said method further comprising overmolding a connector portion opposite the tip.
23. A method in accordance with claim 18 wherein said stacking the electrodes and attached contacts comprises stacking electrodes and dielectric spacer elements so that the spacer elements are sandwiched between the electrodes.
24. A method in accordance with claim 18 further comprising inserting a portion of the tip into the stacked electrodes, and overmolding the stacked electrodes to secure the tip to the electrodes.
25. A method in accordance with claim 18 wherein said press fitting one of the contacts to each of the electrodes via the respective contact apertures comprises press fitting a rim of a contact clip to the contact apertures, whereby a finger extending from the rim extends through the aperture.
26. An electrode assembly for a sensor catheter tip, said assembly comprising:
a first electrode and a second electrode, each electrode comprising a body having a center axis, each electrode comprising a contact point radially spaced from the center axis and radially offset with one another, each electrode comprising at least one aperture radially spaced from the center axis, the electrodes being axially aligned and spaced apart along the center axis; and
a contact element connected to each contact point, each contact element having fingers configured to be spread apart when mated with a lead wire such that the fingers engage, and are electrically coupled to, the corresponding contact point.
27. An electrode assembly in accordance with claim 26 , wherein said contact points of said first and second electrodes are offset approximately 90 degrees from one another.
28. An electrode assembly in accordance with claim 26 , wherein each of said first and second electrodes comprise a disk defined by multiple regions, said contact point positioned in one of said regions, the other of said regions comprising the aperture extending therethrough.
29. An electrode assembly in accordance with claim 26 , further comprising a dielectric spacer element disposed between said first and second electrodes.
30. A catheter tip assembly for an impedance spectroscopy system, said assembly comprising:
a rounded dielectric tip;
a first electrode disk adjacent said tip, said first electrode disk comprising a body having a contact aperture therethrough and a lead aperture therethrough, wherein the contact aperture is configured to receive a first contact by a press fit to electrically and mechanically couple the first contact to the first electrode disk;
a second electrode disk axially spaced from said first electrode disk, said second electrode comprising a body having a contact aperture therethrough and a lead aperture therethrough, wherein the contact aperture is configured to receive a second contact by a press fit to electrically and mechanically couple the second contact to the second electrode disk, wherein said second electrode disk is rotated relative to said first electrode disk about a longitudinal axis so that said contact aperture of said first electrode disk is axially aligned with said lead aperture of said second electrode disk; and
a dielectric spacer element positioned between said first and second electrode disks, said dielectric spacer element having at least one peg extending therefrom, the at least one peg being received within at least one of the first and second electrode disks.
31. A catheter tip assembly in accordance with claim 30 , wherein the dielectric spacer element includes a plurality of openings therethrough, the openings being aligned with the lead apertures and the contact apertures.
32. A catheter tip assembly in accordance with claim 30 , wherein each of the first and second electrode disks include positioning apertures, the at least one peg being received in the positioning aperture of the second electrode disk.
33. A catheter tip assembly in accordance with claim 30 , wherein the tip includes a positioning peg, the positioning peg of the tip being received within the first electrode disk to position the first electrode disk with respect to the first electrode disk.
34. A catheter tip assembly in accordance with claim 30 , further comprising a third electrode disk and a fourth electrode disk, said third and fourth electrode disks substantially identical to said first and second electrode disks, wherein each of said first, second, third and fourth electrode disks are circumferentially rotated relative to one another.
35. A catheter tip assembly in accordance with claim 30 , wherein the first and second contacts comprise a contact clip at an end thereof, said contact clip of each of said first and second contacts press fit into a respective one of said first and second contact apertures, one of said first and second contacts extending through a lead aperture in one of said first and second electrode disks.
36. A catheter tip assembly in accordance with claim 30 , further comprising first and second contacts inserted through said first and second contact apertures, each of said first and second contacts having a different axial length.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/409,268 US20090177070A1 (en) | 2003-10-06 | 2009-03-23 | Catheter tip electrode assembly and method for fabricating same |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US10/679,568 US7062310B2 (en) | 2003-10-06 | 2003-10-06 | Catheter tip electrode assembly and method for fabricating same |
US11/435,155 US7512433B2 (en) | 2003-10-06 | 2006-05-16 | Catheter tip electrode assembly and method for fabricating same |
US12/409,268 US20090177070A1 (en) | 2003-10-06 | 2009-03-23 | Catheter tip electrode assembly and method for fabricating same |
Related Parent Applications (1)
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US11/435,155 Continuation US7512433B2 (en) | 2003-10-06 | 2006-05-16 | Catheter tip electrode assembly and method for fabricating same |
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US20090177070A1 true US20090177070A1 (en) | 2009-07-09 |
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US11/435,155 Expired - Fee Related US7512433B2 (en) | 2003-10-06 | 2006-05-16 | Catheter tip electrode assembly and method for fabricating same |
US12/409,268 Abandoned US20090177070A1 (en) | 2003-10-06 | 2009-03-23 | Catheter tip electrode assembly and method for fabricating same |
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US11/435,155 Expired - Fee Related US7512433B2 (en) | 2003-10-06 | 2006-05-16 | Catheter tip electrode assembly and method for fabricating same |
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US (3) | US7062310B2 (en) |
EP (1) | EP1691684A1 (en) |
JP (1) | JP4757198B2 (en) |
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CA (1) | CA2541071C (en) |
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Also Published As
Publication number | Publication date |
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JP4757198B2 (en) | 2011-08-24 |
EP1691684A1 (en) | 2006-08-23 |
CN1889886B (en) | 2010-06-16 |
IL174745A0 (en) | 2006-08-20 |
CA2541071A1 (en) | 2005-04-21 |
IL174745A (en) | 2010-11-30 |
JP2007507314A (en) | 2007-03-29 |
MXPA06003856A (en) | 2006-07-03 |
WO2005034748A1 (en) | 2005-04-21 |
US7062310B2 (en) | 2006-06-13 |
CN1889886A (en) | 2007-01-03 |
BRPI0415081A (en) | 2006-12-12 |
US20060206023A1 (en) | 2006-09-14 |
US20050075554A1 (en) | 2005-04-07 |
US7512433B2 (en) | 2009-03-31 |
CA2541071C (en) | 2012-12-04 |
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