Medical Devices

Abstract

A method of performing a medical procedure includes advancing a medical device towards a puncture site within a patient's body and positioning a radiofrequency puncture electrode of the medical device adjacent to the puncture site, delivering radiofrequency energy from the radiofrequency puncture electrode to create a puncture at the puncture site, advancing the medical device through the puncture to position an auxiliary electrode of the medical device adjacent a target site within the patient's body, and using the auxiliary electrode for diagnosis, mapping, and / or treatment at the target site.

Description

[Technical field]

[0001] This specification relates to medical devices and procedures. More specifically, this specification relates to intravascular and intracardiac medical procedures and related devices. [Background technology]

[0002] Further improvements are needed with respect to intravascular and intracardiac medical procedures and related devices. Summary of the Invention

[0003] The following summary is intended to introduce the reader to various aspects of the Detailed Description, but is not intended to define or limit any of the invention. A method of performing a medical procedure is disclosed. According to some aspects, the method of performing a medical procedure includes: a. advancing a medical device toward a puncture site in a patient's body and positioning a radiofrequency puncture electrode of the medical device adjacent to the puncture site, b. delivering radiofrequency energy from the radiofrequency puncture electrode to create a puncture at the puncture site, c. advancing the medical device through the puncture to position an auxiliary electrode of the medical device at a target site in the patient's body, and d. using the auxiliary electrode for diagnosis, mapping, and / or treatment at the target site.

[0004] In some embodiments, the puncture site is the fossa ovalis of the patient's heart and the target site is a structure on the left side of the patient's heart. In some embodiments, step c. includes using an auxiliary electrode for pulmonary vein isolation.

[0005] In some embodiments, the target site is the ventricular endocardium. In some examples, step d. includes using an auxiliary electrode for electroanatomical mapping of the target site. In some examples, step d. includes ablating the target site using the auxiliary electrode. In some examples, step d. includes collecting electrical signals from the target site using the auxiliary electrode. In some examples, step d. includes pacing the target site using the auxiliary electrode. In alternative embodiments, the medical device can be operated in a bipolar manner, in which case the auxiliary electrode may be used as a ground electrode. Bipolar devices may be further beneficial in that the energy delivered via the medical device remains concentrated around the two electrodes, substantially limiting the flow of undesired electrical currents through structures such as the heart.

[0006] According to an alternative aspect, a method of performing a medical procedure includes: a. advancing a medical device toward a puncture site within a patient's body and positioning a radiofrequency puncture electrode of the medical device adjacent to the puncture site; b. positioning an auxiliary electrode of the medical device at the puncture site within the patient's body and using the auxiliary electrode for diagnosis and / or mapping at a target site; c. delivering radiofrequency energy from the radiofrequency puncture electrode to create a puncture at the puncture site; d. advancing the medical device through the puncture to reach the target site; and f. optionally, positioning the auxiliary electrode of the medical device at the target site within the patient's body.

[0007] In some embodiments, steps b. and f. include using an auxiliary electrode for pulmonary vein isolation. In some embodiments, steps b. and f. include using an auxiliary electrode for electroanatomical mapping of the target site. In some embodiments, step f. includes ablating the target site using the auxiliary electrode. In some embodiments, steps b. and f. include collecting electrical signals from the target site using the auxiliary electrode. In some embodiments, steps b. and f. include pacing the target site using the auxiliary electrode.

[0008] In some embodiments, the auxiliary electrode is disposed on the shape-changing section of the medical device, and the method further comprises changing a shape of the shape-changing section to anchor the shape-changing section within the blood vessel.

[0009] In some embodiments, the target site includes a wall of a blood vessel, and changing the shape of the shape-changing section places the auxiliary electrode in contact with the target site. In some embodiments, the method further includes using the medical device as a rail for advancing a secondary device towards the target site.

[0010] In some embodiments, step d. includes administering treatment at the target site using an auxiliary electrode and then verifying the treatment using the auxiliary electrode. A medical device is also disclosed. According to some aspects, the medical device includes an elongate member having a distal portion defining a distal end and a proximal portion defining a proximal end. A radiofrequency puncture electrode is at the distal end and a first electrical connector extends proximally from the radiofrequency puncture electrode toward the proximal end for electrically connecting the radiofrequency puncture electrode to a radiofrequency generator. At least a first auxiliary electrode is within the distal portion and disposed proximal to the radiofrequency puncture electrode. A second electrical connector extends proximally from the auxiliary electrode toward the proximal end for electrically connecting the auxiliary electrode to a diagnostic system, a mapping system, and / or a treatment system.

[0011] In some embodiments, the first auxiliary electrode is one of a plurality of longitudinally spaced auxiliary electrodes in the distal portion. In some embodiments, the distal portion includes a shape-changing section and the first auxiliary electrode is within the shape-changing section.

[0012] In some embodiments, the shape-changing section can change from a generally straight shape to a loop shape, a pigtail shape, a balloon shape, a basket shape, a J-shape, a semicircular shape, or a combination thereof.

[0013] In some embodiments, the elongate member is relatively stiff proximal to the shape-changing section. In some embodiments, the medical device is a guidewire and the elongate member has an outer diameter of about 0.014 inches to about 0.060 inches, more preferably about 0.020 inches to about 0.040 inches.

[0014] In some embodiments, the medical device is a microcatheter and the elongate member has an outer diameter of about 1.5F (0.02 inches) to about 6F (0.079 inches), more preferably 2F (0.026 inches) to 3F (0.039 inches).

[0015] In some embodiments, the elongated member comprises a central mandrel and an outer liner. The accompanying drawings are intended to illustrate, but not to limit, examples of the articles, methods, and apparatus of the present disclosure. [Brief description of the drawings]

[0016] [Figure 1] FIG. 1 is a perspective view of an exemplary medical system including a radiofrequency generator, an auxiliary system, a sheath, a dilator, and a medical device. [Diagram 2] FIG. 2 is a side view of the medical device of FIG. 1. [Diagram 3] 3 is a longitudinal cross-sectional view taken through a portion of the medical device of FIG. 2. [Figure 4] FIG. 1 is a partial side view of another exemplary medical device. [Diagram 5] FIG. 1 is a partial side view of another exemplary medical device. [Figure 6] FIG. 1 is a partial side view of another exemplary medical device. [Figure 7] FIG. 1 is a partial side view of another exemplary medical device. [Figure 8] FIG. 1 is a partial side view of another exemplary medical device. [Figure 9] FIG. 1 is a partial side view of another exemplary medical device. [Figure 10] 5 illustrates steps in a method of performing a medical procedure using the sheath and dilator of the system of FIG. 1 and the medical device of FIG. [Figure 11] The next step in the method of FIG. [Figure 12] The next step in the method of FIG. [Figure 13] The next step in the method of FIG. [Figure 14] The next step in the method of FIG. 13 is shown. [Figure 15] The next step in the method of FIG. 14 is shown. [Figure 16] 10 illustrates steps of another method of performing a medical procedure using the sheath of FIG. 1 and the medical device of FIG. 8. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] Various devices, processes, or configurations are described below to provide examples of embodiments of the claimed subject matter. The examples described below do not limit any claim, and any claim may encompass a process, device, or configuration different from those described below. The claims are not limited to a device, process, or configuration having all of the features of any one device, process, or configuration described below, or to features common to more than one or all of the devices, processes, or configurations described below. The devices, processes, or configurations described below may not be embodiments of any of the exclusive rights conferred by the issuance of this patent application. Any of the subject matter described below to which no exclusive rights are conferred by the issuance of this patent application may be the subject of another protected document, e.g., a continuing patent application, and the applicant, inventor, or patentee does not intend to abandon, abandon, or release to the public any such subject matter by its disclosure herein.

[0018] Generally, methods of performing medical procedures and associated medical devices are disclosed herein. More specifically, disclosed herein are medical procedures in which a first anatomical structure (also referred to herein as a "puncture site") is punctured to gain access to a second anatomical structure (also referred to herein as a "target site"), and then a procedure (e.g., diagnosis, mapping, and / or therapy) is performed in association with the target site. In alternative embodiments, the procedure (e.g., diagnosis and / or mapping) is performed before the first anatomical structure is punctured. In the methods disclosed herein, a single medical device is used to both puncture the puncture site and perform the procedure in association with the target site. For example, the medical device may be in the form of a guidewire or microcatheter and may include a radiofrequency electrode at its distal end and one or more auxiliary electrodes disposed proximal to the radiofrequency electrode. The medical device may be advanced toward the puncture site within the patient's body, and the radiofrequency puncture electrode may be positioned adjacent to the puncture site. Radiofrequency energy may then be delivered from the radiofrequency puncture electrode to create a puncture at the puncture site. The medical device may then be advanced through the puncture to position the auxiliary electrode(s) of the medical device adjacent to the target site, and the auxiliary electrode(s) may then be used for diagnosis, mapping, and / or treatment at the target site. Alternatively, the medical device may be advanced toward a puncture site in the patient's body, the radiofrequency puncture electrode may be positioned adjacent to the puncture site, and the auxiliary electrode(s) may then be used for diagnosis and / or mapping of the target site. Radiofrequency energy may then be delivered from the radiofrequency puncture electrode to create a puncture at the puncture site, and the medical device may then be advanced through the puncture to position the auxiliary electrode(s) of the medical device adjacent to the target site, and the auxiliary electrode(s) may then be used for diagnosis, mapping, and / or treatment at the target site.

[0019] In some examples, the puncture site may be the fossa ovalis of the patient's heart and the target site may be a structure on the left side of the patient's heart. For example, the method may include pulmonary vein isolation. In such examples, a radiofrequency puncture electrode may be used to puncture the fossa ovalis of the heart and gain access to the left side of the heart. An auxiliary electrode(s) may then be positioned in or adjacent to the pulmonary vein and used to ablate the wall of the pulmonary vein. The auxiliary electrode(s) may then be further used to assess whether the pulmonary vein isolation was successful (i.e., the auxiliary electrode(s) may collect electrical signals).

[0020] In other examples, the method may include ventricular endocardial ablation. In such examples, a radiofrequency puncture electrode may be used to puncture the fossa ovalis of the heart to gain access to the left side of the heart. An auxiliary electrode(s) may then be placed in the left ventricle and used to collect ECG signals, mapping signals, and / or other diagnostic information. The auxiliary electrode(s) may then be used to ablate the endocardial tissue. The auxiliary electrode(s) may then be used again to collect electrical signals to assess whether the procedure was successful.

[0021] 1, there is shown an exemplary medical system 100. The system generally includes a radiofrequency generator 102, an auxiliary system 104, a sheath 106, a dilator 108, and a medical device 110. The medical device 110 is electrically connected to the radiofrequency generator 102 and the auxiliary system 104, and is insertable through the dilator 108 and the sheath 106 toward a target site within a patient's body.

[0022] The radiofrequency generator 102 may be any suitable generator capable of delivering radiofrequency energy to the medical device 110 to enable the medical device 110 to puncture tissue. One such generator is sold by Baylis Medical Company (Montreal, Canada) under the name RFP-100A RF Puncture Generator.

[0023] The auxiliary system 104 may be, for example, a diagnostic system (e.g., an electrocardiograph system such as CardioLab™ sold by GE Healthcare), a mapping system (e.g., electroanatomical mapping systems such as RHYTHMIA HDx™ by Boston Scientific, CARTO® by Biosense Webster, and EnSite® by Abbot), and / or a therapy system (e.g., a radiofrequency ablation generator or pacing system such as the RFP-100A RF Puncture Generator, CardioLab™, FARASTAR®, and SMARTABLATE® by Baylis Medical Company).

[0024] In the illustrated embodiment, the radio frequency generator 102 and the auxiliary system 104 are shown as two separate subsystems. However, they may be integrated into a single system. Furthermore, in some embodiments, two or more auxiliary systems (e.g., a diagnostic system, a mapping system, and a therapeutic system) may be provided, which may or may not be integrated into a single overall system. If two or more auxiliary systems are provided, each auxiliary system may be connected to the medical device 110 simultaneously, or the auxiliary systems may be connected to the medical device 110 in sequence.

[0025] The sheath 106 may be any suitable sheath capable of providing a conduit for the medical device 110, and the dilator 108 may be any suitable dilator capable of dilating a puncture created by the medical device 110. Examples include the TorFlex® Transseptal Guiding Sheath, the SureFlex® Steerable Guiding Sheath, the VersaCross® Large Access Transseptal Dilator, the regular VersaCross® Transseptal Dilator, and the ExpanSure® Large Access Transseptal Dilator, each of which are sold by Baylis Medical Company (Montreal, Canada).

[0026] 2, the medical device 110 is shown in more detail. In the illustrated embodiment, the medical device 110 includes an elongate member 112 having a distal portion 114 defining a distal end 116 and a proximal portion 118 defining a proximal end 120. The length between the distal end 116 and the proximal end 120 may be, for example, about 180 cm to about 230 cm. In one embodiment, it is about 180 cm, or about 187 cm. A hub 122 is joined to the proximal end 120 and a radiofrequency puncture electrode 124 is at the distal end 116. As shown in FIG. 3, the elongate member 112 includes a central mandrel 126 (such as a solid body or rod or a hollow body or tube) and a liner 128 on the central mandrel. The central mandrel 126 extends proximally from the radio frequency puncture electrode 124 toward the proximal end 120 (not shown in FIG. 3 ) to serve as an electrical connector for the radio frequency puncture electrode 124 and electrically connect the radio frequency puncture electrode 124 to the RF generator 102 (not shown in FIGS. 2 and 3 ) via the hub 122 (not shown in FIG. 3 ). The liner 128 electrically insulates the mandrel 126 (e.g., the liner 128 may be a polytetrafluoroethylene (PTFE) liner). The mandrel 126 further provides rigidity to the elongated member 112. In the illustrated embodiment, the mandrel 126 is of constant diameter along its length. However, in alternative embodiments, the mandrel may increase in diameter as it extends toward the proximal end to provide increased rigidity. In a further alternative embodiment, the mandrel may include a reinforcing member inserted within its lumen to provide increased rigidity.

[0027] Still referring to Figures 2 and 3, in the illustrated embodiment, the elongated member 112 further includes a plurality of auxiliary electrodes, namely a first auxiliary electrode 130a, a second auxiliary electrode 130b, and a third auxiliary electrode 130c (only shown in Figure 2). The auxiliary electrodes 130a-c are disposed proximal to the radiofrequency puncture electrode 124 within the distal portion 114 and are longitudinally spaced apart. In the illustrated embodiment, the auxiliary electrodes 130a-c are in the form of ring electrodes received on the liner 128. As shown in Figure 3, the elongated member 112 further includes a respective electrical connector for each auxiliary electrode (only electrical connector 132a for the first auxiliary electrode 130a and electrical connector 132b for the second auxiliary electrode 130b are shown). In one embodiment, the electrical connector can have multiple paths for each device / system for the electrodes being used. Alternatively, the electrical connector can be an OTW or OTG cable-to-cable connector. The electrical connectors 132a-b are in the form of insulated wires embedded in the liner 128, each extending proximally from each respective auxiliary electrode 130a-b towards the proximal end 120 for electrically connecting the respective auxiliary electrode 130a-b to the auxiliary system 104 via the hub 122. In a further alternative embodiment, the mandrel may be a long metal tube (e.g., a hypotube) having an insulated outside diameter (OD) with an insulated wire extending longitudinally therethrough. The insulated wire serves as an electrical connector for the radiofrequency puncture electrode 124 and extends proximally from the radiofrequency puncture electrode 124 towards the proximal end 120 for electrically connecting the radiofrequency puncture electrode 124 to the RF generator 102 via the hub 122. The hypotube may comprise stainless steel, nitinol, or both. Additionally, the hypotube may be made from metal, plastic, polymer, or any combination thereof, and may be laser cut to modify or change its flexibility or stiffness (e.g., laser cut stainless steel).In an alternative embodiment, the hub 122 coupled to the proximal end 120 of the elongated member 112 is a separate member and is detachable from the wire or microcatheter (i.e., a detachable cable can connect the elongated member and the generator), thereby allowing other devices to be slid onto the elongated member. In an alternative embodiment, the hub is rotatable relative to the elongated member while maintaining communication with the RF generator 102, auxiliary system 104. In such procedures, the hub may be locked or coupled to the elongated member using a coupling mechanism during a portion of the procedure to prevent undesired disengagement and / or rotation of the hub from the elongated member.

[0028] In the illustrated embodiment, the medical device 110 includes three auxiliary electrodes 130a-c. However, in alternative embodiments, the medical device may include another number of auxiliary electrodes (i.e., at least one auxiliary electrode, and preferably a plurality of auxiliary electrodes, such as one or two or four or up to eight auxiliary electrodes).

[0029] Still referring to FIG. 2, in the illustrated embodiment, the distal portion 114 of the elongate member 112 includes a shape-changing section 134. The shape-changing section 134 is changeable between a generally straight shape (shown in dotted lines in FIG. 2 and also shown in FIG. 3) and a J-shape (shown in solid lines in FIG. 2). In the illustrated embodiment, the elongate member 112 is biased toward the J-shape, but may assume a generally straight shape upon application of force (e.g., when confined within the sheath 106 and / or dilator 108). For example, the shape-changing section 134 may include a shape memory material. In an alternative embodiment (not shown), one or more actuation mechanisms may be provided to selectively move the elongate member between the generally straight shape and the J-shape.

[0030] The shape-changing section 134 can generally serve two purposes. First, as the medical device 110 is advanced from the sheath 106 and / or dilator 108 to puncture tissue (e.g., the fossa ovalis), the elongated member 112 assumes a J-shape. This causes the radiofrequency puncture electrode 124 to turn away from additional tissue (e.g., the wall of the left atrium) in front of the radiofrequency puncture electrode 124, preventing inadvertent damage to the additional tissue. Second, as seen in FIG. 2, the auxiliary electrodes 130a-c are in the shape-changing section. As described in more detail below, the shape-changing section 134 can allow the auxiliary electrodes 130a-c to be anchored in and / or positioned relative to a target site (e.g., a pulmonary vein) to facilitate use of the auxiliary electrodes 130a-c.

[0031] 2 and 3, the shape-changing section 134 is changeable between a generally straight shape and a J-shape. In alternative embodiments, as shown in Figures 4-9, the shape-changing section may be changeable between a generally straight shape and a variety of other shapes.

[0032] 4, for example, there is shown a medical device 410 that includes a shape-changing section 434 that is changeable between a generally straight shape (not shown) and a loop shape. Similar to medical device 110, in medical device 410, auxiliary electrodes 430 (only two of which are labeled) are in the shape-changing section 434 and a radiofrequency puncture electrode 424 is at the distal end.

[0033] 5, there is shown a medical device 510 that includes a shape-changing section 534 that is changeable between a generally straight shape (not shown) and a combination of a loop shape and a J-shape. Similar to medical device 110, in medical device 510, auxiliary electrodes 530 (only two of which are labeled) are in the shape-changing section 534 and a radiofrequency puncture electrode 524 is at the distal end.

[0034] As a further example, as shown in Figure 6, a medical device 610 is shown that includes a shape-changing section 634 that is capable of changing between a generally straight shape (not shown) and a balloon shape. Similar to medical device 110, in medical device 610, auxiliary electrodes 630 (only two of which are labeled) are in the shape-changing section 634 and a radiofrequency puncture electrode 624 is at the distal end.

[0035] As a further example, as shown in Figure 7, a medical device 710 is shown that includes a shape-changing section 734 that is capable of changing between a generally straight shape (not shown) and a basket shape. Similar to medical device 110, in medical device 710, auxiliary electrodes 730 (only two of which are labeled) are in the shape-changing section 734 and a radiofrequency puncture electrode 724 is at the distal end.

[0036] As a further example, as shown in Figure 8, a medical device 810 is shown that includes a shape-changing section 834 that is capable of changing between a generally straight shape (not shown) and a pigtail shape. Similar to medical device 110, in medical device 810, auxiliary electrodes 830 (only two of which are labeled) are in the shape-changing section 834 and a radiofrequency puncture electrode 824 is at the distal end.

[0037] As a further example, as shown in Figure 9, a medical device 910 is shown that includes a shape-changing section 934 that is changeable between a generally straight shape (not shown) and a semicircular shape. Similar to medical device 110, in medical device 910, auxiliary electrodes 930 (only two of which are labeled) are in the shape-changing section 934 and a radiofrequency puncture electrode 924 is at the distal end.

[0038] 4, the shape-changing section 434 is spaced apart from the radiofrequency puncture electrode 424 with a mid-section 436 therebetween. The mid-section 436 can have a length of, for example, about 2 cm. In the illustrated embodiment, the section of the medical device 410 immediately proximal to the shape-changing section 434 is collinear with the mid-section 436 for ease of navigation.

[0039] In some embodiments, the elongate member may be relatively stiff proximal to the shape-changing section, for example, the mandrel may increase in diameter proximal to the shape-changing section or may include a reinforcing member proximal to the shape-changing section.

[0040] In some embodiments where the medical device is relatively rigid and has a relatively small outer diameter, the medical device may be considered or referred to as a guidewire. In alternative embodiments, the medical device may have a larger outer diameter and / or may be relatively non-rigid. In some such embodiments, the medical device may be considered or referred to as a microcatheter. For example, the elongate member may optionally have a diameter of about 0.014 inches to about 0.060 inches, more preferably about 0.020 inches to about 0.040 inches, and more preferably about 0.035 inches, and may be relatively rigid and therefore may be considered a guidewire. As a further example, the elongate member may optionally have a diameter of about 1.5F (0.02 inches) to about 6F (0.079 inches), and more preferably about 2F (0.026 inches) to about 3F (0.039 inches), and may be relatively non-rigid and therefore may be considered a microcatheter.

[0041] In the above-described embodiment, the medical device includes a radiofrequency puncture electrode that delivers radiofrequency energy to puncture tissue, in alternative embodiments, the elongate member may include a sharp tip and may puncture tissue using mechanical force.

[0042] In any of the above embodiments, the elongate member may include one or more radiopaque markers and / or one or more echogenic markers. For example, the distal portion may include a tungsten coil.

[0043] In any of the above embodiments, the elongate member may be steerable. In any of the above embodiments, the elongate member may include a lumen. A first exemplary method of performing a medical procedure will now be described with reference to Figures 10-15. In particular, a method of pulmonary vein isolation will be described. The method will be described with reference to the medical system 100 and medical device 500 of Figure 5. However, the method may be performed using other systems and devices, and the devices and systems are not limited to use with the described method.

[0044] 10, a medical device 510 (not visible in FIG. 10), such as a guidewire or microcatheter, may protrude from the dilator 108 and enter the vasculature or heart, and then the dilator 108 and sheath 106 may be advanced toward the heart 1002 via the femoral vein and positioned within the right atrium 1004, such that the radiofrequency puncture electrode 524 (not visible in FIG. 10) of the medical device 510 is positioned adjacent the puncture site, i.e., the fossa ovalis 1006, and then an auxiliary electrode(s) may be used to diagnose, map, and / or treat the target site prior to puncturing the puncture site. In alternative embodiments, the medical device 510 may be advanced toward the heart 1002 from another site, for example, using a superior approach.

[0045] 11, radio frequency energy can then be delivered from a radio frequency generator (not shown) to the radio frequency puncture electrode 524 and from the radio frequency puncture electrode 524 to the puncture site to create a puncture in the fossa ovalis 1006. The radio frequency energy can be delivered in a continuous signal or a pulsed signal. The medical device 510 can be advanced through the puncture to position the radio frequency puncture electrode 524 in the right atrium as the energy is delivered. When the shape-changing section 534 is advanced from the sheath 106 and the dilator 108 to the extent shown in FIG. 11, the shape-changing section 534 assumes a J-shape. As shown in FIG. 12, the dilator 108 can then be advanced through the puncture to dilate it, and the sheath 106 can then be advanced through the puncture. The dilator 108 can then be withdrawn.

[0046] 13 and 14, the medical device 510 can then be advanced further through the puncture to position the auxiliary electrodes 530 (only two of which are labeled) above the sheath 106. As the medical device is advanced further, the shape-changing section 534 assumes a looped shape, as shown in FIG. 13. The medical device 510 can continue to be advanced until the auxiliary electrodes 530 are adjacent the target site, i.e., the wall 1008 of the pulmonary vein, as shown in FIGS. 14 and 15. More specifically, the medical device 510 can be inserted into the left upper pulmonary vein, such that the looped portion of the shape-changing section 534 is anchored within the pulmonary vein, with the auxiliary electrodes 530 in contact with the wall 1010 of the pulmonary vein. The auxiliary electrodes 530 can then be used for diagnosis, mapping, and / or therapy at the target site. For example, prior to therapy, electrical signals can be collected by the auxiliary electrodes 530 and transmitted to the auxiliary system 104 (not shown) for diagnostic purposes. Energy can then be delivered from the auxiliary system 104 to the auxiliary electrode 530 to ablate tissue for therapeutic purposes (e.g., radio frequency ablation or pulsed field ablation). Following ablation, electrical signals can again be collected by the auxiliary electrode 530 and transmitted to the auxiliary system 104 to confirm the success of the ablation. For example, the directionality of electrical signal propagation can be determined to assess whether the procedure was successful.

[0047] 16, another exemplary method of performing a medical procedure will be described. In particular, a method of ventricular endocardial ablation will be described. The method will be described with reference to the medical system 100 and medical device 810 described above. However, the method may be performed using other devices, and the device and system are not limited to use with the described method.

[0048] The method may begin in a manner similar to the above-described method of pulmonary vein isolation. That is, Figs. 10-12 are generally applicable to the method of ventricular endocardial ablation, and the description thereof will not be repeated for the sake of brevity. Referring to Fig. 16, after the fossa ovalis 1006 is punctured and the sheath 106 is advanced through the puncture, the sheath 106 and medical device 810 may be steered toward the left ventricle 1012, and the shape-changing section 834 (labeled in Fig. 8) of the medical device 810 may be advanced from the sheath 106, so that it assumes a pigtail shape, whereby the auxiliary electrode 830 (visible in Fig. 8) contacts the ventricular endocardium 1014. The auxiliary electrode 834 may then be used for diagnosis, mapping, and / or therapy at the target site. For example, prior to therapy, ECG signals, voltage mapping signals, and / or other signals may be collected by the auxiliary electrode 830 and transmitted to the auxiliary system 104 for diagnostic purposes. Energy can then be delivered from the auxiliary system 104 to the auxiliary electrode 830 for therapeutic purposes. For example, energy can be delivered for ablation (e.g., radio frequency ablation or pulsed field ablation) or pacing. Following therapy, electrical signals can again be collected by the auxiliary electrode 830 and transmitted to the auxiliary system 104 to confirm the success of the therapy.

[0049] In any of the above examples, all of the auxiliary electrodes may be used at a given time (e.g., energy may be delivered to all of the auxiliary electrodes to ablate a large portion of tissue), or only one or a subset of the auxiliary electrodes may be used at a given time (e.g., energy may be delivered to a single one of the auxiliary electrodes to ablate a smaller portion of tissue).

[0050] In any of the above embodiments, after the initial use of the auxiliary electrodes, the medical device can be repositioned and the auxiliary electrodes can be used again. In any of the above embodiments, a visualization technique can be used to determine or confirm the location of the distal portion of the medical device. For example, fluoroscopy (e.g., to visualize radiopaque markers on the medical device), computed tomography, transesophageal echocardiography (to visualize echogenic markers on the medical device), or angiography (to determine the orientation and / or location of the distal portion) may be used.

[0051] In any of the above embodiments, a secondary device, such as a cryoballoon for cryoablation or another ablation device (such as a pulsed field ablation (PFA) catheter) can be delivered over the medical device toward the target site, with the medical device acting as a rail.

[0052] In any of the above embodiments, the medical device may be advanced through a support device other than a sheath and dilator. For example, the medical device may be advanced through a microcatheter or a coronary catheter. In such embodiments, the microcatheter is used as an insulator that can reduce the effect of the auxiliary electrode on the surrounding electric field.

[0053] In any of the above embodiments, a support device, such as a stylet, can be inserted into the lumen of the elongate member to facilitate tenting and piercing the puncture site. In alternative embodiments, another region within the patient's body may be an additional or alternative target site, such as the superior vena cava (SVC), the right ventricle, a cardiac isthmus (e.g., mitral isthmus, tricuspid isthmus), the posterior wall or roofline of the left atrium, the bundle of His, the atrioventricular node, the great cardiac vein, the coronary sinus, and / or the anterior ventricular vein (with its septal branch).

[0054] While the above description provides examples of one or more processes, devices, or configurations, it will be understood that other processes, devices, or configurations may be within the scope of the following claims.

[0055] To the extent that any amendments, characterizations, or other assertions previously made (in this patent application or in any related patent application or patent, including any parent, sibling, or progeny) with respect to any prior art or other art may be construed as a disclaimer of any subject matter supported by the present disclosure of this application, applicant hereby cancels and revokes such disclaimer. Applicant also respectfully suggests that it may be necessary to reconsider any prior art previously discussed in any related patent application or patent, including any parent, sibling, or progeny.

Claims

1. an elongate member having a distal portion defining a distal end and a proximal portion defining a proximal end; a radio frequency puncture electrode at the distal end of the elongate member and a first electrical connector extending proximally from the radio frequency puncture electrode towards the proximal end of the elongate member for electrically connecting the radio frequency puncture electrode to a radio frequency generator; at least a first auxiliary electrode in the distal portion disposed proximally of the radiofrequency puncture electrode; and a second electrical connector extending proximally from the auxiliary electrode toward the proximal end for electrically connecting the auxiliary electrode to a diagnostic, mapping, and / or therapeutic system. A medical device comprising:

2. The medical device of claim 1 , wherein the first auxiliary electrode is one of a plurality of longitudinally spaced auxiliary electrodes in the distal portion.

3. The medical device of claim 1 or 2, wherein the distal portion includes a shape-changing section, and the first auxiliary electrode is within the shape-changing section.

4. 4. The medical device of claim 3, wherein the shape-changing section is changeable from a generally straight shape to a loop shape, a pigtail shape, a balloon shape, a basket shape, a J-shape, a semicircular shape, or a combination thereof.

5. The medical device of claim 3 or 4, wherein the elongate member is relatively stiff proximal to the shape-changing section.

6. The medical device of any one of claims 1 to 5, wherein the medical device is a guidewire and the elongate member has an outer diameter of about 0.014 inches to about 0.060 inches.

7. The medical device of any one of claims 1 to 6, wherein the medical device is a microcatheter and the elongate member has an outer diameter of about 0.02 inches to about 0.079 inches.

8. The medical device of any one of claims 1 to 7, wherein the elongate member comprises a central mandrel and an outer liner.

9. The medical device of claim 2 , wherein the distal portion includes a mid-section proximal to the distal end and a shape-changing section proximal to the mid-section.

10. The medical device of claim 9 , wherein the plurality of auxiliary electrodes are disposed along the shape-changing section.

11. 11. The medical device of claim 9 or 10, wherein the shape-changing section is changeable from a generally straight shape to a loop shape, a pigtail shape, a balloon shape, a basket shape, a J-shape, a semicircular shape, or a combination thereof.

12. The medical device of any one of claims 9 to 11, wherein the elongate member is relatively stiff proximal to the shape-changing section.

13. The medical device of any one of claims 9 to 12, wherein the medical device is a guidewire and the elongate member has an outer diameter of about 0.014 inches to about 0.060 inches.

14. The medical device of any one of claims 9 to 13, wherein the medical device is a microcatheter and the elongate member has an outer diameter of about 0.02 inches to about 0.079 inches.

15. The medical device of any one of claims 9 to 14, wherein the elongate member comprises a central mandrel and an outer liner.

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