This invention relates to catheters and electrophysiologic catheters, in particular, catheters for cardiac tissue ablation and diagnostics.
Radiofrequency (RF) ablation of cardiac and other tissue is a well-known method for creating thermal injury lesions at the tip of an electrode. Radiofrequency current is delivered between a skin (ground) patch and the electrode, or between two electrodes. Electrical resistance at the electrode-tissue interface results in direct resistive heating of a small area, the size of which depends upon the size of the electrode, electrode tissue contact area, and current (density). Further tissue heating results from conduction of heat within the tissue to a larger zone. Tissue heated beyond a threshold of approximately 50-55 degrees C. is irreversibly injured (ablated).
Resistive heating is caused by energy absorption due to electrical resistance. Energy absorption is related to the square of current density and inversely with tissue conductivity. Current density varies with contact area conductivity, voltage and inversely with the square of the distance from the ablating electrode. Therefore, energy absorption varies with conductivity, the square of applied voltage, and inversely with the fourth power of the distance from the electrode. Resistive heating, therefore, is most heavily influenced by distance, and penetrates a very small distance from the ablating electrode. The rest of the lesion is created by thermal conduction from the area of resistive heating. This imposes a limit on the size of ablation lesions that can be delivered from a surface electrode.
Theoretical methods to increase lesion size would include increasing electrode size, increasing the area of electrode contact with tissue, increasing tissue conductivity and penetrating the tissue to achieve greater depth and increase the area of contact, and delivering RF until maximal lesion size has been achieved (60-90 seconds for full maturation).
The electrode can be introduced to the tissue of interest directly (for superficial/skin structures), surgically, endoscopically, laparoscopically or using percutaneous transvascular (catheter-based) access. Catheter ablation is a well-described and commonly performed method by which many cardiac arrhythmias are treated.
Catheter ablation is sometimes limited by insufficient lesion size. Ablation of tissue from an endovascular approach results not only in heating of tissue, but heating of the electrode. When the electrode reaches critical temperatures, denaturation of blood proteins causes coagulum formation. Impedance can then rise and limit current delivery. Within tissue, overheating can cause steam bubble formation (steam “pops”) with risk of uncontrolled tissue destruction or undesirable perforation of bodily structures. In cardiac ablation, clinical success is sometimes hampered by inadequate lesion depth and transverse diameter even when using catheters with active cooling of the tip. Theoretical solutions have included increasing the electrode size (increasing contact surface and increasing convective cooling by blood flow), improving electrode-tissue contact, actively cooling the electrode with fluid infusion, changing the material composition of the electrode to improve current delivery to tissue, and pulsing current delivery to allow intermittent cooling.
Conventional catheters are equipped to measure temperature at their distal sections which are adapted for contact with tissue. Typically, these catheters include a thermocouple wire pair 80 and 82 that extend from the control handle, through the catheter shaft and into the distal section where a “hot” or temperature measuring junction H of the wire pair is positioned. As shown in
Thus, there is a desire for a catheter with a temperature sensor with a more precise location of its temperature sensing element. In particular, there is a desire for a catheter with a thermocouple wire pair having a more precise location of its “hot” junction, an improved profile, a more durable construction, and an easier method of assembly. Where space is always a constraint within a catheter, there is a further desire for a catheter with a thinner thermocouple wire pair.
The present invention is directed to a temperature sensor having a more precise temperature sensing location. The temperature sensor includes a coaxial thermocouple wire pair having a more precise “hot” junction at which a first and second metallic material electrically connect with each other for measuring temperature.
In one embodiment, the present invention includes a temperature sensing tensile member for use with a medical device, for example, an electrophysiologic catheter, comprising an elongated body having a proximal end and a distal end. The body includes a core of a first metallic material, the core defining a longitudinal axis, a first coaxial layer of insulating material circumferentially surrounding the core, and a second coaxial layer of a second metallic material circumferentially surrounding the first layer, the second metallic material being different from the first metallic material, the first layer of insulating material electrically insulating the core and second layer from each other along the length of the body and a second layer of insulating material surrounding the assembly and electrically insulating the assembly from the environment. The member further including a solder cap on the distal end, the solder cap electrically connecting the core and the second layer at the distal end.
In a more detailed embodiment, the core includes constantan and the second layer includes copper, or vice versa, and the insulating material includes ceramic and/or a polymer.
In a more detailed embodiment, the member further comprises an outer protective sheath that is electrically nonconductive.
In a more detailed embodiment, the body has been drawn through a die.
The present invention is also directed to an electrophysiologic catheter comprising an elongated catheter body, a distal electrode member, and a temperature sensor having a tensile body, the tensile body extending through the catheter body and having at least a distal end received in the distal electrode member. The temperature sensor comprising a core of a first metallic material defining a longitudinal axis, a coaxial insulating material circumferentially surrounding the core, a coaxial layer of a second metallic material circumferentially surrounding the insulating material, a coaxial insulating material circumferentially surrounding the assembly; and a solder cap on the distal end of the tensile body, the solder cap electrically connecting the core and the layer.
In a more detailed embodiment, the body has been drawn through a die and the coaxial insulating material includes ceramic particulates.
The present invention further includes a method of manufacturing a coaxial thermocouple wire pair member adapted for use with an electrophysiologic catheter, comprising providing a core of a first metallic material defining a longitudinal axis, coaxially surrounding the core with an insulating ceramic material, coaxially surrounding the insulating material with a second metallic material different from the first metallic material, drawing the member through a die, insulating the assembly with a polymer coating, and applying solder on a distal end of the member to electrically connecting the core and the layer at the distal end.
In a more detailed embodiment, the method includes trimming the distal end to expose the core and the layer after drawing the member through a die and before applying solder on the distal end.
These and other features and advantages of the present invention will be better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings wherein:
With reference to
As shown in
With reference to
The present invention includes a method of manufacturing a thermocouple wire pair member 10. The thermocouple wire pair first may be shapened by drawing processes owned and practiced by Fort Wayne Metals Research Products Corporation (Fort Wayne, Ind.), a manufacturer of precision wire-based materials for medical and industrial applications. With reference to
After the member 10′ has been drawn into the member 10 with an elongated body 12 with a desirable diameter, the distal end 12D is prepared for a solder cap by being trimmed to expose the core 14 and the layer 16, and dipped in solder to form distal solder cap 20D, as shown i
The preceding description has been presented with reference to presently preferred embodiments of the invention. Workers skilled in the art and technology to which this invention pertains will appreciate that alterations and changes in the described structure may be practiced without meaningfully departing from the principal, spirit and scope of this invention. As understood by one of ordinary skill in the art, the drawings are not necessarily to scale. Also, different features of one or more embodiments may be combined as needed or appropriate. Moreover, the catheters described herein may be configured to apply various energy forms, including microwave, laser, RF and/or cryogens. Accordingly, the foregoing description should not be read as pertaining only to the precise structures described and illustrated in the accompanying drawings, but rather should be read consistent with and as support to the following claims which are to have their fullest and fair scope.
This application is a continuation application of U.S. patent application Ser. No. 14/714,904, filed May 18, 2015, entitled “Catheter with Coaxial Thermocouple,” issued as U.S. Pat. No. 10,285,754 on May 14, 2019, the entire contents of which is hereby incorporated by reference.
Number | Name | Date | Kind |
---|---|---|---|
3343589 | Holzl | Sep 1967 | A |
4408088 | Foote | Oct 1983 | A |
4512827 | Gill | Apr 1985 | A |
4731127 | Itoyama | Mar 1988 | A |
4732619 | Nanigian | Mar 1988 | A |
5111002 | Hollander | May 1992 | A |
5423808 | Edwards et al. | Jun 1995 | A |
5456682 | Edwards | Oct 1995 | A |
5464485 | Hall, Jr. | Nov 1995 | A |
5606974 | Castellano et al. | Mar 1997 | A |
5718701 | Shai et al. | Feb 1998 | A |
5853409 | Swanson | Dec 1998 | A |
6049737 | Simpson et al. | Apr 2000 | A |
6120476 | Fung | Sep 2000 | A |
6176857 | Ashley | Jan 2001 | B1 |
6830374 | Gray | Dec 2004 | B1 |
8215955 | Lee | Jul 2012 | B2 |
10285754 | Beeckler | May 2019 | B2 |
20020165534 | Hayzelden et al. | Nov 2002 | A1 |
Number | Date | Country |
---|---|---|
101539095 | Sep 2009 | CN |
201950084 | Aug 2011 | CN |
103654947 | Mar 2014 | CN |
2454620 | Feb 1976 | DE |
0 113 554 | Jul 1984 | EP |
0 928 600 | Jul 1999 | EP |
H05-299703 | Nov 1993 | JP |
H09-502259 | Mar 1997 | JP |
2004-148131 | May 2004 | JP |
2010-060445 | Mar 2010 | JP |
WO 9501656 | Jan 1995 | WO |
WO 1996041654 | Dec 1996 | WO |
WO 2015041315 | Mar 2015 | WO |
Entry |
---|
European Search Report dated Sep. 22, 2016 from corresponding European Patent Application No. 16169868.3. |
European Search Report dated Dec. 5, 2016 from corresponding European Patent Application No. 16169868.3. |
Chinese Office Action and Search Report dated Apr. 10, 2020 for Application No. 201610329891.4, 15 pages. |
European Commumcation dated Oct. 24, 2019 for Application No. 16169868.3, 5 pages. |
Japanese Office Action dated Feb. 27, 2020 for Application No. 2016-098608, 6 pages. |
Chinese Office Action dated Sep. 23, 2020 for Application No. 201610329891.4, 9 pages. |
Japanese Notification of Reasons for Refusal dated Oct. 27, 2020 for Application No. 2016-098608, 4 pages. |
Number | Date | Country | |
---|---|---|---|
20190223952 A1 | Jul 2019 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 14714904 | May 2015 | US |
Child | 16373702 | US |