The present invention relates to catheters that have an active distal portion, including an irrigated tip electrode, particularly useful for ablating heart tissue.
Ablation of cardiac tissue is well known as a treatment for cardiac arrhythmias. In radio-frequency (RF) ablation, for example, a catheter is inserted into the heart and brought into contact with tissue at a target location. RF energy is then applied through electrodes on the catheter to heat tissue to a destructive temperature in order to create a lesion for the purpose of breaking arrhythmogenic current paths in the tissue.
Irrigated catheters are now commonly used in ablation procedures. Open-loop irrigation provides many benefits including cooling of the electrode and tissue which prevents overheating of tissue that can otherwise cause adjacent blood to form char and coagulum. Despite efficient cooling of the electrode tip, under certain circumstances, adjacent catheter tip structures are heated by the tissue lesion site and the formation of coagulum and/or char can occur on these structures which are typically formed from a non-electrically conductive elastomer or plastic. The historic mode of operation relies on a scavenging effect where the tip electrode cooling fluid also cools these adjacent structures to some degree. However, it is desirable for an irrigated ablation catheter to prevent the formation of char and/or coagulum on adjacent, non-ablating tip structures and surfaces by convective and direct cooling.
Accordingly, it is desirable that an irrigated ablation catheter provide efficient cooling of adjoining non-ablating catheter tip structures which, due to their close proximity, are heated by the tissue lesion site.
The present invention seeks to minimize, if not prevent, the formation of char and/or coagulum on adjacent structures of an irrigated ablation tip electrode by convectively or directly cooling these structures. A catheter is constructed with an electrically conductive tip which has the benefit of being more thermally conductive than nonconductive or elastomeric structures to which it is bonded. The electrode tip has a tissue contacting surface which electrically conducts RF energy to the tissue. The tip has an adjacent surface which is coated or covered with a non-electrically conductive material and such, prevents RF conduction to the tissue contacting that surface. With thermally conductive substrate electrode underneath the non-electrically conductive material, the nonablating surface can be cooled by porting to effectively scavenge some of the irrigation flow through the tip electrode to the non-ablating surface.
Accordingly, the present invention is directed to a catheter having an elongated catheter body and a tip electrode with a shell, an internal support member, and an elastomeric tubing wherein the shell has a neck and a chamber, and the support member has a proximal portion inserted in the neck of the shell and a distal portion extending into the chamber of the shell. The proximal portion has a fluid through-hole which is in communication with a fluid channel provided between the neck of the shell and the proximal portion of the support member to define a fluid passage between the fluid through-hole and the chamber for cooling the neck of the shell and hence cooling at least a portion of the tubing covering the neck to minimize formation of char and coagulum thereon. In a more detailed embodiment, the fluid channel is helical along an outer surface of the proximal portion to maximize surface area exposure of the neck to irrigation fluid for convective cooling.
In another embodiment, the fluid channel has axial and radial branches to pass fluid to the chamber and to irrigation ports provided in the neck of the shell and a nonconductive tubing of the distal section covering the shell. The irrigation ports allow fluid to pass to the outside of the tip electrode to directly cool the nonablating areas of the tip electrode.
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
The outer diameter of the catheter body 12 is not critical, but is preferably no more than about 8 french, more preferably 7 french. Likewise the thickness of the outer wall 20 is not critical, but is thin enough so that the central lumen 18 can accommodate puller members (e.g., puller wires), lead wires, and any other desired wires, cables or tubings. If desired, the inner surface of the outer wall 20 is lined with a stiffening tube 22 to provide improved torsional stability. A disclosed embodiment, the catheter has an outer wall 20 with an outer diameter of from about 0.090 inch to about 0.94 inch and an inner diameter of from about 0.061 inch to about 0.065 inch.
Distal ends of the stiffening tube 22 and the outer wall 20 are fixedly attached near the distal end of the catheter body 12 by forming a glue joint 25 with polyurethane glue or the like. A second glue joint (not shown) is formed between proximal ends of the stiffening tube 20 and outer wall 22 using a slower drying but stronger glue, e.g., polyurethane.
Components that extend between the control handle 16 and the deflectable section 14 pass through the central lumen 18 of the catheter body 12. These components include lead wires 30T and 30R for the tip electrode 17 and a plurality of ring electrodes 21 carried on the distal section 15, an irrigation tubing 38 for delivering fluid to the tip electrode, a cable 33 for an electromagnetic position sensor 34 carried in the distal section 15, puller wires 32a, 32b for deflecting the intermediate section 14, and a pair of thermocouple wires 41, 42 to sense temperature at the distal section 15.
Illustrated in
The tubing 19 of the intermediate section 14 is made of a suitable non-toxic material that is more flexible than the catheter body 12. A suitable material for the tubing 19 is braided polyurethane, i.e., polyurethane with an embedded mesh of braided stainless steel or the like. The size of each lumen is not critical, but is sufficient to house the respective components extending therethrough.
A means for attaching the catheter body 12 to the intermediate section 14 is illustrated in
If desired, a spacer (not shown) can be located within the catheter body between the distal end of the stiffening tube (if provided) and the proximal end of the intermediate section. The spacer provides a transition in flexibility at the junction of the catheter body and intermediate section, which allows this junction to bend smoothly without folding or kinking. A catheter having such a spacer is described in U.S. Pat. No. 5,964,757, the disclosure of which is incorporated herein by reference.
Each puller wire 32a and 32b is preferably coated with Teflon®. The puller wires can be made of any suitable metal, such as stainless steel or Nitinol and the Teflon coating imparts lubricity to the puller wire. The puller wire preferably has a diameter ranging from about 0.006 to about 0.010 inch.
As shown in
Proximal ends of the puller wires 32a and 32b are anchored in the control handle 16. Distal ends of the puller wires 32a and 32b are anchored in the distal section 15, as described further below. Separate and independent longitudinal movements of the puller wires relative to the catheter body 12, which results in, respectively, deflection of the intermediate section 14 along a plane, are accomplished by suitable manipulation of a deflection member of the control handle 16. Suitable deflection members and/or deflection assemblies are described in U.S. Publication No. US2010/0168827 A1 and U.S. Publication No. US2008/0255540 A1, the entire disclosures of both of which are hereby incorporated by reference.
With reference to
The tip electrode 17 defines a longitudinal axis and is of at least a two-piece configuration that includes an electrically conductive dome shell 50 as shown in
As shown in
With reference to
The through-hole 61 extends through the entire longitudinal length of the support member 52, through both the proximal portion 52P and the distal portion 52D, thus providing a passage through the support member 52. The passage of through-hole 61 has a proximal portion 61P with a small diameter, a distal portion 61D with a larger diameter forming a step 61S therebetween. The distal portion 62D houses at least a proximal portion of the position sensor 34. A protective tubing 82 may be provided for a distal portion of the position sensor 34 extending into the chamber 51. The proximal portion 61P allows the sensor cable 33 to extend proximally from the sensor 34. A proximal end of the sensor 34 rests against the step 61S.
The through-hole 60 extends through proximal portion 52P and feeds into and connects with a fluid channel 65 formed in an outer circumferential surface 69 of the distal portion 52D. The channel 65 has a proximal opening 71 and a distal opening 73. In the illustrated embodiment, the channel 65 is a helical pattern (e.g., about three full loops or 1080 degrees) that extends along the length of the distal portion 52D and gives the distal portion an appearance of being “threaded”. The proximal opening 71 communicates with the through-hole 60 and the distal opening communicates with the plenum chamber 51. Thus, the channel 65 provides fluid communication between the through-hole 61 and the chamber 51 along the outer surface 69 of the distal portion 52D.
With the support member 52 inserted in the shell 50 forming the tip electrode 17 as shown in
It is understood that the channel 65 may assume a variety of shapes and patterns so long as it exposes the inner surface 85 of the shell 50 and its neck 62 to cooling irrigation fluid passed into the tip electrode via the through-hole 60. Direct cooling of the neck 62 effectively cools the connector tubing 24 of the distal section 15 covering the neck 62 of the shell 50 and minimizes the formation of char and coagulum on the nonconducting, nonablating surface of the tubing 24.
The total hydraulic resistance (combined resistance of the ports as well as the branches) should be balanced between the branches that feed the neck 62 and those that feed the chamber 51 such that both zones of the tip are irrigated. This can be accomplished by varying the number and size of the fluid ports 56 of the shell 50. In one embodiment, the ports 56 have a diameter of about 0.0035 in. Additionally, the cross sectional area of the branches can be adjusted to increase or reduce the hydraulic resistance of any given branch.
The shell 50 and the support member 52 are constructed of a biocompatible metal, including a biocompatible metal alloy. A suitable biocompatible metal alloy includes an alloy selected from stainless steel alloys, noble metal alloys and/or combinations thereof. In one embodiment, the shell is constructed of an alloy comprising about 80% palladium and about 20% platinum by weight. In an alternate embodiment, the shell 50 and the member 52 are constructed of an alloy comprising about 90% platinum and about 10% iridium by weight. The shell can formed by deep-drawing manufacturing process which produces a sufficiently thin but sturdy shell wall that is suitable for handling, transport through the patient's body, and tissue contact during mapping and ablation procedures.
Distal ends of the thermocouple wires 41 and 42 may be covered in a nonconductive cover or sheath, for example, a polyester heat shrink sleeve. The sheath is an electrically insulating, second protective covering over the thermocouple wires (proximal to thermocouple junction 80) to prevent abrasion against the support member 52. Surrounding a distal portion of the sheath may be another nonconductive tubing, for example, a polyimide tubing. The tubing is constructed of a thermally conductive material which provides electrical isolation between the thermocouple junction 80 and the support member 52 which is energized with RF potential.
In the illustrated embodiment, the sensor 34 and cable 33 are front-loaded into the support member 52 during assembly of the tip electrode 17. That is, before the shell 50 is mounted on the support member 52, the sensor 34 and its cable 33 are fed (proximal end of the cable first) into the through hole 61 from the distal end of the support member. A distal end of the tubing 82 covering the sensor 34 is filled and packed with a suitable adhesive so as to seal the tubing 82 against fluid leakage from the cavity 51. The shell 50 is then mounted on the support member 52 with the distal portion 52 extending into the cavity 51, the proximal portion 52D filling the neck 62 and the rim abutting against the lip 67. The rim and the lip are soldered to fixedly attach the shell 60 and the support member 52.
As shown in
As understood by one of ordinary skill in the art, each lead wire 30R is attached to its corresponding ring electrode by any suitable method. A preferred method for attaching a lead wire to a ring electrode involves first making a small hole through the wall of the tubing 24. Such a hole can be created, for example, by inserting a needle through the non-conductive covering and heating the needle sufficiently to form a permanent hole. The lead wire is then drawn through the hole by using a microhook or the like. The end of the lead wire is then stripped of any coating and welded to the underside of the ring electrode, which is then slid into position over the hole and fixed in place with polyurethane glue or the like. Alternatively, each ring electrode is formed by wrapping a lead wire 30R around the non-conductive tubing 24 a number of times and stripping the lead wire of its own insulated coating on its outwardly facing surfaces.
The tip electrode 17 is electrically connected to a source of ablation energy (not shown) by the lead wire 30T. The ring electrodes 21 are electrically connected to an appropriate mapping or monitoring system by respective lead wires 30R.
The lead wires 30T and 30R pass through the lumen 27 (
The preceding description has been presented with reference to certain exemplary embodiments of the invention. Workers skilled in the art and technology to which this invention pertains will appreciate that alterations and changes to the described structure may be practiced without meaningfully departing from the principal, spirit and scope of this invention. It is understood that the drawings are not necessarily to scale. Accordingly, the foregoing description should not be read as pertaining only to the precise structures described and illustrated in the accompanying drawings. Rather, it should be read as consistent with and as support for the following claims which are to have their fullest and fairest scope.
This application is a continuation of U.S. application Ser. No. 13/732,297 filed Dec. 31, 2012, now U.S. Pat. No. 9,144,460, the disclosure of which is incorporated herein in its entirety.
Number | Name | Date | Kind |
---|---|---|---|
5643197 | Brucker et al. | Jul 1997 | A |
5964757 | Ponzi | Oct 1999 | A |
6053912 | Panescu et al. | Apr 2000 | A |
6171275 | Webster, Jr. | Jan 2001 | B1 |
6605087 | Swartz et al. | Aug 2003 | B2 |
6611699 | Messing | Aug 2003 | B2 |
6764487 | Mulier et al. | Jul 2004 | B2 |
7217268 | Eggers et al. | May 2007 | B2 |
7276061 | Schaer et al. | Oct 2007 | B2 |
7819866 | Bednarek | Oct 2010 | B2 |
9144460 | Clark | Sep 2015 | B2 |
20080255540 | Selkee | Oct 2008 | A1 |
20090005768 | Sharareh et al. | Jan 2009 | A1 |
20090093810 | Subramaniam et al. | Apr 2009 | A1 |
20100137851 | Lin et al. | Jun 2010 | A1 |
20100168728 | Wang | Jul 2010 | A1 |
20100168827 | Schultz | Jul 2010 | A1 |
20110270244 | Clark | Nov 2011 | A1 |
20130317375 | Garcia | Nov 2013 | A1 |
20140163548 | Christian | Jun 2014 | A1 |
20140187893 | Clark | Jul 2014 | A1 |
Number | Date | Country |
---|---|---|
1690510 | Aug 2006 | EP |
2382935 | Nov 2011 | EP |
WO2011115787 | Sep 2011 | WO |
Entry |
---|
Extended European Search Report dated Mar. 27, 2014 in EP Application No. 13199550.8, 7 pages. |
Number | Date | Country | |
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20160008064 A1 | Jan 2016 | US |
Number | Date | Country | |
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Parent | 13732297 | Dec 2012 | US |
Child | 14860439 | US |