This document relates to medical devices and medical procedures. More specifically, this document relates to intravascular and intracardiac medical procedures, and related devices.
The following summary is intended to introduce the reader to various aspects of the detailed description, but not to define or delimit any invention.
Methods for carrying out medical procedures are disclosed. According to some aspects, a method for carrying out a medical procedure includes: a. advancing a medical device towards a puncture site in a patient's body and positioning a radiofrequency puncture electrode of the medical device adjacent the puncture site; b. delivering radiofrequency energy from the radiofrequency puncture electrode to create a puncture in 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.
In some examples, the puncture site is a fossa ovalis of the patient's heart, and the target site is a structure of a left side of the patient's heart.
In some examples, step c. includes using the auxiliary electrode for pulmonary vein isolation.
In some examples, the target site is the ventricular endocardium.
In some examples, step d. includes using the auxiliary electrode for electroanatomic mapping of the target site. In some examples, step d. includes using the auxiliary electrode to ablate the target site. In some examples, step d. includes using the auxiliary electrode to collect electrical signals from the target site. In some examples, step d. includes using the auxiliary electrode to pace the target site. In alternative embodiments, the medical device is operable in a bipolar manner, in which case the auxiliary electrode may be used as a grounding electrode. A bipolar device may be further beneficial in that the energy delivered via the medical device would remain concentrated around the two electrodes, substantially limiting the undesirable flow of current through structures such as the heart.
In alternative aspects, a method for carrying out a medical procedure includes: a. advancing a medical device towards a puncture site in a patient's body and positioning a radiofrequency puncture electrode of the medical device adjacent the puncture site; b. positioning an auxiliary electrode of the medical device at a puncture site in 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 in the puncture site; and 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 in the patient's body.
In some examples, steps b. and f. include using the auxiliary electrode for pulmonary vein isolation.
In some examples, steps b. and f. include using the auxiliary electrode for electroanatomic mapping of the target site. In some examples, step f. includes using the auxiliary electrode to ablate the target site. In some examples, steps b. and f. include using the auxiliary electrode to collect electrical signals from the target site. In some examples, steps b. and f. include using the auxiliary electrode to pace the target site.
In some examples, the auxiliary electrode is positioned in a shape-changing section of the medical device, and the method further includes changing the shape of the shape-changing section to anchor the shape-changing section in a vessel.
In some examples, the target site includes a wall of the vessel, and changing the shape of the shape-changing section positions the auxiliary electrode in contact with the target site.
In some examples, the method further includes using the medical device as a rail to advance a secondary device towards the target site.
In some examples, step d. includes using the auxiliary electrode to perform a treatment at the target site, and then using the auxiliary electrode to confirm the treatment.
Medical devices are also disclosed. According to some aspects, a 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 towards the proximal end, for electrically connecting the radiofrequency puncture electrode to a radiofrequency generator. At least a first auxiliary electrode is in the distal portion, positioned proximally of the radiofrequency puncture electrode. A second electrical connector extends proximally from the auxiliary electrode towards the proximal end, for electrically connecting the auxiliary electrode to a diagnostic system, a mapping system, and/or a treatment system.
In some examples, the first auxiliary electrode is one of a plurality of auxiliary electrodes that are longitudinally spaced apart in the distal portion.
In some examples, the distal portion includes a shape-changing section, and the first auxiliary electrode is in the shape-changing section.
In some examples, 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 semi-circular shape, or a combination thereof.
In some examples, the elongate member is relatively stiff proximal of the shape-changing section.
In some examples, the medical device is a guidewire, and the elongate member has an outer diameter of between about 0.014 inches to about 0.060 inches, more preferably between about 0.020 inches to about 0.040 inches.
In some examples, the medical device is a microcatheter and the elongate member has an outer diameter of between about 1.5F (0.02 inches) to about 6F (0.079 inches), more preferably between 2F (0.026 inches) to 3F (0.039 inches).
In some examples, the elongate member comprises a central mandrel and an outer liner.
The accompanying drawings are for illustrating examples of articles, methods, and apparatuses of the present disclosure and are not intended to be limiting. In the drawings:
Various apparatuses or processes or compositions will be described below to provide an example of an embodiment of the claimed subject matter. No example described below limits any claim and any claim may cover processes or apparatuses or compositions that differ from those described below. The claims are not limited to apparatuses or processes or compositions having all of the features of any one apparatus or process, or composition described below or to features common to multiple or all of the apparatuses or processes or compositions described below. It is possible that an apparatus or process or composition described below is not an embodiment of any exclusive right granted by issuance of this patent application. Any subject matter described below and for which an exclusive right is not granted by issuance of this patent application may be the subject matter of another protective instrument, for example, a continuing patent application, and the applicants, inventors or owners do not intend to abandon, disclaim or dedicate to the public any such subject matter by its disclosure in this document.
Generally disclosed herein are methods for carrying out medical procedures, and related medical devices. 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 treatment) is carried out in relation to the target site. In an alternative example, a procedure (e.g., diagnosis and/or mapping) is carried out 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 to carry out the procedure in relation to 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 that are positioned proximally of the radiofrequency electrode. The medical device may be advanced towards a puncture site in a patient's body and the radiofrequency puncture electrode may be positioned adjacent the puncture site. Radiofrequency energy may then be delivered from the radiofrequency puncture electrode to create a puncture in the puncture site. The medical device may then be advanced through the puncture to position the auxiliary electrode(s) of the medical device adjacent a 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 towards a puncture site in a patient's body and the radiofrequency puncture electrode may be positioned adjacent 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 in the puncture site, and then advancing the medical device through the puncture to position the auxiliary electrode(s) of the medical device adjacent a target site, and, using the auxiliary electrode(s) for diagnosis, mapping, and/or treatment at the target site.
In some examples, the puncture site may be the fossa ovalis of a patient's heart, and the target site may be a structure of the left side of the patient's heart. For example, the methods may involve pulmonary vein isolation. In such examples, the radiofrequency puncture electrode may be used to puncture the fossa ovalis of the heart, to gain access to the left side of the heart. The auxiliary electrode(s) may then be positioned in or adjacent a pulmonary vein, and may be used to ablate the wall of the pulmonary vein. The auxiliary electrode(s) may then further be used to assess whether the pulmonary vein isolation was successful (i.e. i.e. the auxiliary electrode(s) may collect electrical signals).
In other examples, the methods may involve ventricular endocardial ablation. In such examples, the radiofrequency puncture electrode may be used to puncture the fossa ovalis of the heart, to gain access to the left side of the heart. The auxiliary electrode(s) may then be positioned in the left ventricle, and may be used collect an ECG signal, a mapping signal, and/or other diagnostic information. The auxiliary electrode(s) may then be used to ablate endocardial tissue. The auxiliary electrode(s) may then again be used to collect electrical signals, to assess whether the procedure was successful.
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The radiofrequency generator 102 may be any suitable generator that can deliver radiofrequency energy to the medical device 110, to allow for 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.
The auxiliary system 104 may be, for example, a diagnostic system (e.g. an electrocardiogram system, such as CardioLab™ sold by GE Healthcare), a mapping system (e.g. an electroanatomical mapping system, such as RHYTHMIA HDx™ by Boston Scientific, CARTO® by Biosense Webster, and EnSite™ by Abbot), and/or a treatment system (e.g. a radiofrequency ablation generator or a pacing system, such as RFP-100A RF Puncture Generator by Baylis Medical Company, CardioLab™, FARASTAR™, and SMARTABLATE®.
In the example shown, the radiofrequency generator 102 and the auxiliary system 104 are shown as two separate sub-systems; however, they may be integrated into a single system. Furthermore, in some examples, more than one auxiliary system may be provided (e.g., a diagnostic system, a mapping system, and a treatment system), which may or may not be integrated into a single overall system. If more than one auxiliary system is provided, each auxiliary system may be connected to the medical device 110 at the same time, or the auxiliary systems may be connected to the medical device 110 in turn.
The sheath 106 may be any suitable sheath that can provide a conduit for the medical device 110, and the dilator 108 may be any suitable dilator that can dilate a puncture created by the medical device 110. Examples include the TorFlex™ Transseptal Guiding Sheath, SureFlex® Steerable Guiding Sheath, VersaCross® Large Access Transseptal Dilator, regular VersaCross® Transseptal Dilator, and ExpanSure® Large Access Transseptal Dilator, each of which is sold by Baylis Medical Company (Montreal, Canada).
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In the example shown, the medical device 110 includes 3 auxiliary electrodes 130a-c; however, in alternative examples, 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 1 or 2 or 4 or up to 8 auxiliary electrodes).
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The shape changing section 134 may generally serve two purposes: Firstly, as the medical device 110 is advanced out of the sheath 106 and/or dilator 108 to puncture tissue (e.g. the fossa ovalis), the elongate member 112 will assume the J-shape. This causes the radiofrequency puncture electrode 124 to turn away from additional tissue that is in front of the radiofrequency puncture electrode 124 (e.g. the wall of the left atrium), to prevent inadvertent damage to the additional tissue. Secondly, as can be seen in
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In some examples, the elongate member can be relatively stiff proximal of the shape changing section. For example, the mandrel may increase in diameter proximal of the shape changing section, or may include a stiffening member proximal of the shape-changing section.
In some examples, in which the medical device is relatively stiff and has a relatively small outer diameter, the medical device may be considered as or referred to as a guidewire. In alternative examples, the medical device may have a larger outer diameter and/or may be relatively non-stiff. In some such examples, the medical device may be considered as or referred to as a microcatheter. For example, the elongate member may in some cases have a diameter of between about 0.014 inches to about 0.060 inches. In embodiments, the elongate member has a diameter between about 0.020 inches to about 0.040 inches. In some embodiments, the elongate member has a diameter of about 0.035 inches and is relatively stiff, and may thus be considered as a guidewire. For further example, the elongate member may in some cases have a diameter of between about 1.5F (0.02 inches) to about 6F (0.079 inches). In some embodiments, the elongate member has a diameter of between about 2F (0.026 inches) to about 3F (0.039 inches) and be relatively non-stiff, and may thus be considered as a microcatheter.
In the examples described above, the medical device includes a radiofrequency puncture electrode, which delivers radiofrequency energy to puncture tissue. In alternative examples, the elongate member may include a sharp tip, and may use mechanical force to puncture tissue.
In any of the above examples, 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.
In any of the above examples, the elongate member may be steerable.
In any of the above examples, the elongate member may include a lumen.
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The method may begin in a similar fashion to the above-described method for pulmonary vein isolation. That is,
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 section of tissue), or 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 section of tissue).
In any of the above examples, after 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 examples, visualization techniques may be used to determine or confirm the position of the distal portion of the medical device. For example, fluoroscopy (e.g. to visualize radiopaque markers on the medical device), computerized tomography, transesophageal echocardiography (to visualize echogenic markers on the medical device) or angiography (to determine the orientation and/or position of the distal portion) may be used.
In any of the above examples, a secondary device, such as a cryoballoon for cryoablation or another ablation device (such as pulsed field ablation (PFA) catheter), can be delivered over the medical device towards the target site, with the medical device serving as a rail.
In any of the above examples, the medical device may be advanced through a supporting device other than a sheath and a dilator. For example, the medical device may be advanced through a microcatheter or coronary catheter. In such examples, the microcatheter be used as an insulator that can reduce influence on electric fields around the auxiliary electrodes.
In any of the above examples, a supporting device such as a stylet may be inserted to a lumen of the elongate member, to facilitate tenting and puncture of the puncture site.
In alternative examples, another area within the patient's body may be an additional or alternative target site, for example the superior vena cava (SVC), the right ventricle, cardiac isthmuses (e.g., mitral isthmus, cavotricuspid isthmus), posterior wall of the left atrium or roofline, the His bundle, the atrioventricular node, the great cardiac vein, the coronary sinus, and/or the anterior interventricular vein (with septal branches).
While the above description provides examples of one or more processes or apparatuses or compositions, it will be appreciated that other processes or apparatuses or compositions may be within the scope of the accompanying claims.
To the extent any amendments, characterizations, or other assertions previously made (in this or in any related patent applications or patents, including any parent, sibling, or child) with respect to any art, prior or otherwise, could be construed as a disclaimer of any subject matter supported by the present disclosure of this application, Applicant hereby rescinds and retracts such disclaimer. Applicant also respectfully submits that any prior art previously considered in any related patent applications or patents, including any parent, sibling, or child, may need to be re-visited.
This application claims priority to U.S. Provisional Patent Application No. 63/318,856, filed Mar. 11, 2022.
Number | Date | Country | |
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63318856 | Mar 2022 | US |