The disclosure relates generally to medical treatment devices and techniques, and, in some aspects, to methods and devices for diagnosis and treatment of cardiac valves. The present disclosure provides improvements over the state of the art.
The present disclosure provides various systems and methods for removing clips, cysts and other structures from valve leaflets. The disclosure further provides systems for modifying or removing luminal valve leaflets. The disclosure also provides other innovations, as set forth below.
For purposes of illustration, and not limitation, exemplary embodiments of a catheter, which can also be used as a robotic manipulator, are presented in
With reference to
The catheter includes a first elongate inner body 10 having a proximal end and a distal end. The inner body 10 is illustrated with an illustrative cone-shaped atraumatic distal tip 24 that is configured to spread applied stress out over a larger area, which can be of particular benefit when contacting delicate anatomical structures. The first elongate inner body 10 is slidably disposed within the at least one elongate passage of the elongate tubular main body 22.
Also illustrated is a second elongate inner body 20 having a proximal end and a distal end that is slidably disposed within the at least one elongate passage of the elongate tubular main body 22, which is suitably configured to maintain registration of bodies 10 and 20 with respect to each other and hold them together. Bodies 10 and 20 can be housed in a common passage, or in individual passages defined within body 22. Body 20 is slidably disposed with respect to the first inner body 10, wherein an exposed distal region 26 of body 20 is illustrated as protruding beyond the distal end of main body 22.
As illustrated, the distal end of the first and second inner elongate bodies 10, 20 are preferably biased or otherwise configured to be curled or steered away from the longitudinal axis in a proximal direction when the first elongate inner body is advanced distally with respect to the main body by virtue of inner body 10 being removed from body 22. Bodies 10, 20 can be configured to curl as illustrated when advanced distally from body 22 by making bodies 10, 20 at least in part from shape memory materials, and/or by utilizing a steering wire that travels the length of the body 10, 20 that is attached to a distal end of each of the bodies 10, 20, such as by way of a ring (e.g., a radiopaque marker band) that is attached to the distal end of the bodies. In another embodiment, one or more of bodies 10, 20 can be formed at least in part by thermoplastic or other polymeric or composite material that is molded with a preformed bend therein. Such a pre-bent or pre-formed body 10, 20 can then be loaded, for example, into main body 22, wherein main body 22 maintains the bodies 10, 20 in a straight orientation until they bodies 10, 20 are advanced distally with respect to main body 22, at which time they revert to their curved shape and regain at least some of their original curvature.
Main body 22 can simply be an overwrap or a sheath in some implementations that functions to maintain the bodies 10, 20 in a parallel relationship and optionally maintains the bodies 10, 20 in a relative orientation until the bodies 10, 20 are advanced distally with respect to body 22. In other implementations, body 22 can be more sophisticated such as a multi-lumen extrusion including a plurality of lumens for slidably containing bodies 10, 20, and other devices, as desired. In lieu of a main body 22 or overwrap, bodies 10, 20 can alternatively be fused or adhered to each other, or be provided with an adjustable coupling that runs their lengths that permits relative slidability of bodies 10, 20.
If desired, each of the first elongate inner body 10 and second elongate inner body 20 can each define one or more lumens along their respective lengths. The lumen(s) can be used, for example, for passage of a further medical instrument such as a guidewire or viewing scope, for directing electrical conductors, and the like, and/or for passage of a steering wire along the length of body 10, 20 terminating, for example, in a marker band at the distal end of body 10, 20 that the steering wire attaches to. Other examples of suitable steering mechanisms can be found in U.S. Pat. Nos. 6,030,360, and 6,579,278, which are incorporated by reference herein in their entireties for any purpose whatsoever. Either body 10, 20 if equipped with such a passage can additionally or alternatively include a movable body (e.g., core wire, snare catheter, etc.) slidably disposed therein.
If the passage within body 10 includes a snare catheter (such as that described in U.S. patent application Ser. No. 13/824,198, filed May 1, 2013), the snare catheter can be directed out of the distal end of body 10 to provide a landing or target zone for a guidewire that is directed through the distal end of body 20 (not shown). This permits a guidewire that traverses through the distal end of the body 20 to be captured by the snare catheter that extends outwardly from body 10, thereby permitting the guidewire extending from the distal end of body 20 to be pulled into the distal end of body 10, and advanced through the body 10 and externalized or otherwise directed out of the proximal end of body 10 (not shown).
If desired, the guidewire disposed in body 20 can include an electrically conductive core wire surrounded by a jacket made from dielectric/insulating material. The jacket can be removed from a portion of the core wire to expose a portion of the core wire. In a further embodiment, as illustrated in
If desired, the guidewire can be provided with more than one conducting layer as embodiment 400 in
Conductive layer 410 can be formed, for example, from a metallic tube, such as a hypotube, in turn be defined by a tubular body that defines at least one opening 422 therethrough. For example, the at least one opening can be spiral shaped (via laser cutting) and winds around the first insulating layer, resulting in the remaining conductive material also winding around the first insulating layer. Alternatively, the at least one opening and the tubular body define a plurality of articulating segments, similar to those defined in U.S. Pat. No. 8,530,783, Feb. 3, 2010, U.S. Pat. No. 5,605,543, filed Jan. 30, 1996, U.S. patent application Ser. No. 10/969,088, filed Oct. 20, 2004, or WO2017117092, each of which is incorporated by reference herein in its entirety for any purpose whatsoever.
The disclosure also provides an electrosurgical system including a radio frequency power supply, such as that described in U.S. Pat. No. 6,296,636, which is incorporated by reference herein in its entirety for any purpose whatsoever operably coupled to the electrically conductive core wire of the elongate catheters (and/or of the second conductors of catheters) disclosed herein. Thus, the radio frequency power supply can be operably (and selectively) coupled to the electrically conductive core wire and to the second electrical conductor, as desired. Similarly, the disclosure also provides an ultrasonic surgical system, such as an ultrasonic scalpel, including an ultrasonic power source, such as that disclosed in U.S. Pat. No. 6,514,267, which is incorporated by reference herein in its entirety for any purpose whatsoever.
In further embodiments, and with reference to
The disclosed embodiments of articulating catheters can be used to perform the procedures described in the journal publications annexed to U.S. Provisional Application Ser. No. 62/567,203, filed Oct. 2, 2017. These articles are set forth in the Appendix of that Application and include (i) “Intentional Percutaneous Laceration of the Anterior Mitral Leaflet to Prevent Outflow Obstruction During Transcatheter Mitral Valve Replacement”, Babaliaros et al, J.A.C.C.: Cardiovascular Interventions, Vol. 10, No. 8, 2017, and (ii) “Intentional Laceration of the Anterior Mitral Valve Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Replacement”, J.A.C.C.: Cardiovascular Interventions, Vol. 9, No. 7, 2016. The portion of 62/567,203 including the aforementioned publications is hereby incorporated by reference in its entirety. When an electrically exposed portion of the guide wire is in alignment with the leaflet, the ends of the catheter can be withdrawn partially, the electrical current can be turned on, and the exposed portion of the guidewire can be pulled through the leaflet, cutting the leaflet.
Any suitable power level and duty cycle can be used in accordance with the disclosed embodiments. For example, continuous duty cycle (cutting) radiofrequency (“RF”) energy can be used, for example, at a power level between about 50 and 100 Watts, or any increment therebetween of about one watt. The cuts can be made by applying power for between about one half of a second and about five seconds, or any increment therebetween of about one tenth of a second.
As a further example, the movable body (e.g., 20, or a slidable device within a lumen defined by body 20) can include a dart passer that is configured to advance a dart having a suture attached thereto out of the distal end of the second elongate inner body and into a receiving cuff disposed in the lumen of the first elongate inner body, in accordance with the teachings of US2013/0310853, which is incorporated by reference herein in its entirety for any purpose whatsoever. For example, the receiving cuff can be disposed within a lumen defined in body 10 at is attached to a filament/suture that passes through the lumen of body 10 that can receive a dart attached to or resting on the distal end of a hypotube that is advanced through body 20, wherein the dart has a trailing suture that passes through the body of the hypotube. After connecting the dart and cuff, the suture attached to the cuff or the suture attached to the dart can be advanced withdrawing the coupling from the patient, and leaving behind the looped suture.
In accordance with further aspects, the rotational position of the first elongate inner body 10 can be fixed with respect to the rotational position of the second elongate inner body 20. Or, if desired, the rotational positions of each of body 10 and 20 can be controlled by a user at a control actuator/Luer lock at a proximal location of the catheter.
Each of bodies 10, 20 can be made from a variety of materials, including multilayer polymeric extrusions, such as those described in U.S. Pat. No. 6,464,683 to Samuelson or U.S. Pat. No. 5,538,510 to Fontirroche, the disclosure of each being incorporated by reference herein in its entirety. Other structures are also possible, including single or multilayer tubes reinforced by braiding, such as metallic braiding material. Any of the catheters, manipulators, guidewires, or other catheters disclosed herein or portions thereof (e.g., portions 10, 20) can be provided with regions of varying or stepped-down stiffness with length using any of the techniques set forth in U.S. Pat. No. 7,785,318, which is incorporated by reference herein in its entirety for any purpose whatsoever.
Any surface of various components of the system described herein or portions thereof can be provided with one or more suitable lubricious coatings to facilitate procedures by reduction of frictional forces. Such coatings can include, for example, hydrophobic materials such as PolyTetraFluoroEthylene (“PTFE”) or silicone oil, or hydrophilic coatings such as Polyvinyl Pyrrolidone (“PVP”). Other coatings are also possible, including, echogenic materials, radiopaque materials and hydrogels, for example.
One or more actuators can be provided to actuate relative proximal and distal movement of bodies 10, 20 with respect to main body 22. Such actuators typically provide either two handles for push-pull actuation, or the actuator can be more exotic. For example, it is also possible to use other actuators as are known in the art, such as threaded rotating actuators similar to those for retractable sheaths as described in U.S. Pat. No. 6,488,694 to Lau and U.S. Pat. No. 5,906,619 to Olson, the specifications of which are incorporated herein by reference.
With reference to
As described herein, when practicing the illustrative methods, the exposed portion of the core wire or second conductor can be advanced through the valve leaflet through a peripheral edge of the valve leaflet. In some implementations, the valve leaflet can be a mitral valve leaflet, such as a native or artificial/replacement anterior or posterior mitral valve leaflet, or a native or artificial/replacement tricuspid, pulmonary or aortic valve leaflet. It will be appreciated that the disclosed systems can be used with respect to any suitable native or artificial/replacement valve leaflet.
If desired, the disclosed guidewire can include a mid-shaft insulator to protect the operator from electrosurgical energy when the guidewire tip is used for electrosurgical traversal cutting inside the patient. The disclosed guidewire can be accompanied by a detachable spring-loaded connector cable that plugs into the Medtronic Force FX C generator and allows for a secure insulative connection to the generator. The detachable connector allows for fast and easy exchange of catheters over the disclosed guidewire. Two additional accessories can be provided; a wire gripper and a kinker block. The wire gripper can resemble a standard guidewire torquer to assist with guidewire traction when using the mid-shaft surface for electrosurgical cutting. The kinker block can be provided to create a reproducible kink aligned with the un-insulated portion to create a focused cutting surface for laceration. Thus, the illustrated embodiment includes a guidewire, a spring-loaded connector cable, a wire gripper, and a kinker block.
The guidewire can be composed of a 304V stainless steel guidewire covered with an outer insulative layer. The distal tip, the mid-shaft cutting surface (center section of wire) and proximal end can be denuded of insulation. The mid-shaft cutting surface preferably does not contact the patient during electrosurgery using the distal tip. The distal tip typically does not contact the patient during electrosurgery using the mid-shaft. The proximal end typically does not contact the patient. The generator connector cable, wire gripper, and kink blocker are preferably non-patient contact parts and are constructed of standard materials.
The guidewire of
A common application of the guidewire can be BASILICA (Bioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction during transcatheter aortic valve replacement). The procedure is performed under general anesthesia or under moderate sedation at the discretion of the institutional heart team. The BASILICA procedure typically has three steps as described elsewhere in this patent application, including (i) leaflet traversal by cutting using the distal guidewire tip, followed by (ii) leaflet laceration by cutting using the guidewire mid-shaft lacerating surface, immediately followed by (iii) TAVR using devices marketed outside the scope of this IDE. These steps are all typically guided by fluoroscopy and adjunctive echocardiography as needed.
First, catheter access is obtained typically via multiple arterial introducer sheaths. At various steps of the procedure, two or four catheters can be used for BASILICA (often with catheter pairs introduced side-by-side into single large-bore introducer sheaths), one for hemodynamics and angiography, and one for TAVR) and at least one venous introducer sheath for temporary transvenous pacing. Anticoagulation with heparin or equivalent achieves an activated clotting time is typically 250-300s. Cerebral embolic protection devices are employed at the discretion of the operator. Two retrograde catheters are positioned, using a guidewire anchor as needed, in the LVOT and Aorta respectively. Care is taken to avoid entrapment of mitral valvular structures. A snare catheter is positioned in the LVOT. A traversal guiding catheter directs the TELLTALE guidewire against the base of the coronary cusp targeted for laceration, using fluoroscopic and/or echocardiographic guidance.
Traversal cutting is accomplished by transcatheter electrosurgery by connecting the electrically exposed proximal end of the guidewire to a spring-loaded connector cable to facilitate short bursts of “pure, cutting” radiofrequency energy typically at approximately 20 W-50 W. The guidewire is repositioned as needed until it crosses the aortic leaflet and is snare-retrieved and externalized as described above.
Next, the temporary shielding over the exposed region of the middle of the guidewire is removed and the center denuded section of the guidewire is intentionally kinked using a kinker block (e.g.,
Laceration cutting can be performed by positioning the laceration (denuded mid-shaft) surface along the intended leaflet base, and applying traction on both free ends of the guidewire with the wire grippers while simultaneously apply electrosurgery energy (typically 50-70 W) in short bursts, until the laceration is complete and the guidewire is free. The guidewire and BASILICA catheters are removed. With the leaflets cut, installation of a TAVR is then performed as usual.
Still a further implementation of a kinker block is depicted in
The devices and methods disclosed herein can be used for other procedures in an as-is condition, or can be modified as needed to suit the particular procedure. In view of the many possible embodiments to which the principles of this disclosure may be applied, it should be recognized that the illustrated embodiments are only preferred examples of the disclosure and should not be taken as limiting the scope of the disclosure.
The present patent application is a continuation-in-part of and claims the benefit of priority to International Application No. PCT/US20/55160, filed Oct. 9, 2020. The present patent application also claims the benefit of priority to U.S. Patent Application No. 63/047,995, filed Jul. 3, 2020 and U.S. Patent Application No. 63/077,579, filed Sep. 12, 2020. The present patent application also claims the benefit of priority to and is a continuation-in-part of U.S. patent application Ser. No. 16/563,925, filed Sep. 8, 2019, which in turn claims the benefit of U.S. Patent Application Ser. No. 62/728,413, filed Sep. 7, 2018, and International Patent Application No. PCT/US18/48177, filed Aug. 27, 2018, which in turn claims the benefit of priority to U.S. Provisional Application Ser. No. 62/550,347, filed Aug. 25, 2017, U.S. Provisional Application Ser. No. 62/567,203, filed Oct. 2, 2017, U.S. Provisional Patent Application Ser. No. 62/663,518, filed Apr. 27, 2018, U.S. Provisional Application Ser. No. 62/688,378, filed Jun. 21, 2018, and U.S. Provisional Patent Application Ser. No. 62/712,194, filed Jul. 30, 2018.
Number | Date | Country | |
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62550347 | Aug 2017 | US | |
62567203 | Oct 2017 | US | |
62663518 | Apr 2018 | US | |
62688378 | Jun 2018 | US | |
62712194 | Jul 2018 | US | |
62728413 | Sep 2018 | US | |
63047995 | Jul 2020 | US | |
63077579 | Sep 2020 | US |
Number | Date | Country | |
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Parent | 16563925 | Sep 2019 | US |
Child | 17148616 | US | |
Parent | PCT/US2018/048177 | Aug 2018 | US |
Child | 16563925 | US | |
Parent | PCT/US2020/055160 | Oct 2020 | US |
Child | PCT/US2018/048177 | US |