Systems and methods for transcatheter surgery - Patents.com

Abstract

The system for dissecting tissue includes a catheter including one or more dissecting devices configured to dissect tissue at the first and second exposed windows. The system also includes one or more aligners, the one or more aligners being deployable and configured to facilitate contact between the one or more dissecting devices and tissue at the first and / or second exposed windows. TIFF2024540907000002.tif94159

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 63 / 257,451, filed October 19, 2021, the contents of which are incorporated by reference in their entirety under 35 USC §119(e). [Background technology]

[0002] Technology Background Transcatheter heart valve repair and replacement has transformed the treatment of heart failure patients too sick to undergo surgery. With a growing experience base, the efficacy and safety of this procedure are enabling it to be expanded to younger, healthier patients.

[0003] However, this younger patient population presents new challenges as they can outlive the implanted devices they accept. Surgical revision surgery has been facilitated to remove previously implanted devices so that they do not interfere with new repairs and devices, which is not easy with transcatheter procedures. Also, due to device endothelialization, which is often desirable to minimize long-term inflammatory responses, it is difficult to design devices that are easily removable after long-term implantation. As a result, new techniques and tools are needed to perform surgery that can reliably modify or remove autologous tissue and previously implanted devices to allow new repairs.

[0004] These types of clinically significant problems require amputation of the valve leaflets. For example, in transcatheter aortic valve replacement (TAVR), the new valve may cause blockage of the coronary arteries by the existing native or prosthetic leaflets. To prevent blockage, the existing leaflets must be sliced ​​in half or removed. As a second example, in transcatheter mitral valve replacement, sometimes it is necessary to remove part of the native anterior leaflet to ensure that the left ventricular outflow tract remains open. Or, if the valve has been previously repaired, the anterior leaflet must be amputated so that a clip remains attached to the posterior leaflet and is pressed against the left ventricular free wall by the new valve.

[0005] A major challenge in cutting tissue inside the heart is that the tissue contains calcified deposits. Such calcifications in the leaflet and annulus tissue often cause valve stenosis that must be repaired. Several groups have proposed catheter-delivered shock waves to break up calcium deposits in the leaflets. Similarly, calcified lesions in and around the coronary arteries lead to stenosis and in-stent restenosis. Some techniques use a liquid-filled balloon with a shock wave generator to break up the calcium in the tissue surrounding the vessel, allowing for balloon expansion. Excimer lasers are used to open blocked vessels with moderately calcified lesions. Summary of the Invention

[0006] overview The present disclosure relates to a system for lacerating tissue, comprising: a catheter including one or more lacerators configured to lace tissue at a first exposed window and a second exposed window; and one or more aligners that are deployable and configured to facilitate contact between the one or more lacerators and tissue at the first exposed window and / or the second exposed window upon deployment.

[0007] In some embodiments, the present disclosure relates to a system in which a first exposure window is disposed in the catheter to allow a dissecting device of the one or more dissecting devices to pierce the tissue to form an opening in the tissue; and a first aligner of the one or more aligners is disposed to facilitate contact between the tissue and the second exposure window when at least a portion of the catheter is disposed in the opening in the tissue, when deployed. In some embodiments, the present disclosure relates to a system in which a second aligner of the one or more aligners is disposed to facilitate positioning of the catheter relative to the tissue for piercing of the tissue by the dissecting device, when deployed. In some embodiments, the present disclosure relates to a system in which the second aligner is disposed on the opposite side of the tissue from the first aligner when the first aligner is deployed. In some embodiments, the present disclosure relates to a system in which the first exposure window and the second exposure window are adjacent. In some embodiments, the present disclosure relates to a system further comprising an energy source that is connectable to at least one of the one or more dissecting devices and configured to transmit energy to tissue upon activation, the transmitted energy passing through at least one of the one or more dissecting devices to tissue at the first and / or second exposed windows. In some embodiments, the present disclosure relates to a system in which at least one of the one or more dissecting devices comprises an optical fiber; the energy source is a laser source configured to transmit laser energy to tissue, the transmitted laser energy passing through the optical fiber to tissue at the first and / or second exposed windows to dissect the tissue. In some embodiments, the present disclosure relates to a system in which at least one of the one or more dissecting devices is one or more electrodes; the energy source is an electrosurgical energy source configured to transmit electrosurgical energy to tissue, the transmitted electrosurgical energy passing through tissue at the first and / or second exposed windows from or between the one or more electrodes to dissect the tissue.In some embodiments, the present disclosure relates to a system in which the catheter comprises at least one of the one or more aligners; the first exposed window is disposed in the catheter distal to the second exposed window; and the second exposed window is disposed in the catheter distal to the at least one of the one or more aligners. In some embodiments, the present disclosure relates to a system in which the catheter comprises at least one of the one or more aligners; the first exposed window is disposed in the catheter distal to the at least one of the one or more aligners; and the at least one of the one or more aligners is disposed in the catheter distal to the second exposed window. In some embodiments, the present disclosure relates to a system further comprising a second catheter, the catheter being positionable through the second catheter; and the second catheter comprising at least one of the one or more aligners. In some embodiments, the present disclosure relates to a system further comprising one or more working channels for delivering a working volume in the direction of the first exposed window and / or the second exposed window to facilitate dissection, evacuation of debris, and visualization. In some embodiments, the present disclosure relates to a system further comprising a second catheter, the catheter being positionable through the second catheter; and the second catheter comprising an imaging system for visualizing tissue in contact with the one or more dissecting devices at the first and / or second exposed windows. In some embodiments, the present disclosure relates to a system, the one or more aligners comprising at least one of an expandable balloon; one or more hinged arms rotatably coupled to the catheter; or a deformable segment at the distal end of the catheter.

[0008] The present disclosure relates to a catheter for dissecting tissue, the catheter including: one or more dissecting devices configured to dissect tissue at a first exposed window and a second exposed window; and one or more aligners that are deployable and configured to facilitate contact between the one or more dissecting devices and tissue at the first exposed window and / or the second exposed window upon deployment.

[0009] In some embodiments, the present disclosure relates to a catheter, wherein a first exposed window is disposed in the catheter to allow a dissecting device of the one or more dissecting devices to pierce the tissue to form an opening in the tissue; and a first aligner of the one or more aligners is disposed to facilitate contact between the tissue and the second exposed window when at least a portion of the catheter is disposed in the opening in the tissue. In some embodiments, the present disclosure relates to a catheter, wherein a second aligner of the one or more aligners is disposed to facilitate positioning of the catheter relative to the tissue for puncture of the tissue by the dissecting device when deployed.

[0010] The present disclosure relates to a method including the steps of advancing a catheter toward tissue; puncturing the tissue at a first exposed window of the catheter to form an opening in the tissue; advancing at least a portion of the catheter through the opening in the tissue; deploying one or more aligners to facilitate contact between a dissecting device and the tissue at a second exposed window of the catheter; and slicing the tissue at the second exposed window of the catheter.

[0011] In some embodiments, the present disclosure relates to a method further comprising the steps of: deploying a first aligner of the one or more aligners to facilitate positioning of the catheter relative to the tissue for puncture of the tissue by the dissecting device; and deploying a second aligner of the one or more aligners when at least a portion of the catheter is disposed in the opening in the tissue to facilitate contact between the tissue and the dissecting device at a second exposure window. In some embodiments, the present disclosure relates to a method, wherein the first aligner is disposed on an opposite side of the tissue from the second aligner when the second aligner is deployed. [Brief description of the drawings]

[0012] Various aspects of the present disclosure can be further described with reference to the accompanying drawings. Similar structures are referenced by similar numerals throughout the several figures. The drawings shown are not necessarily drawn to scale, and generally, emphasis is placed on explaining the principles of the present disclosure. Therefore, the specific structural and functional details disclosed herein should not be interpreted as limiting, but merely as a representative basis for teaching those skilled in the art to use one or more exemplary embodiments in various ways.

[0013] [Figure 1] 1 illustrates an exemplary transcatheter surgical system 100 for transcatheter surgery, according to one or more embodiments. [Diagram 2] 1 illustrates an exemplary catheter tip design of a transcatheter surgical system 100 for transcatheter surgery, according to one or more embodiments. [Diagram 3] 1 illustrates an irrigation and aspiration mechanism integrated into the catheter tip of a transcatheter surgical system 100 for transcatheter surgery, according to one or more embodiments. [Figure 4] 1 illustrates an exemplary catheter including one or more aligners for a transcatheter surgical system, according to one or more embodiments. [Diagram 5]1 illustrates an exemplary catheter including one or more aligners for a transcatheter surgical system, according to one or more embodiments. [Figure 6] 1 illustrates an exemplary catheter including one or more aligners for a transcatheter surgical system, according to one or more embodiments. [Figure 7] 1 illustrates an exemplary catheter including one or more hinged arms as an aligner for a transcatheter surgical system, according to one or more embodiments. [Figure 8] 8 illustrates an exemplary method of performing a transcatheter procedure using the catheter of FIG. 7, according to one or more embodiments. [Figure 9] 1 illustrates an exemplary catheter including one or more deformable portions as aligners for a transcatheter surgical system, according to one or more embodiments. [Figure 10] 10 illustrates an exemplary method of performing a transcatheter procedure using the catheter of FIG. 9, according to one or more embodiments. [Figure 11] 1 illustrates an exemplary handle system of a catheter for a transcatheter surgical system, according to one or more embodiments. [Figure 12] 1 illustrates an example of a catheter including one or more mechanical mechanisms for deploying aligners for a transcatheter surgical system, according to one or more embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] Detailed Description Various detailed aspects of the present disclosure are disclosed herein, which are to be read in conjunction with the accompanying drawings. However, it should be understood that the disclosed aspects are merely exemplary. In addition, the examples given in connection with the various aspects of the present disclosure are intended to be illustrative and not limiting.

[0015] Throughout this specification, the following terms have the meanings expressly associated therewith, unless the context clearly indicates otherwise. The phrases "in one embodiment" and "in some embodiments" used herein may refer to the same embodiment, but do not necessarily do so. Furthermore, the phrases "in another embodiment" and "in some other embodiments" used herein may refer to different embodiments, but do not necessarily do so. Thus, as described below, various embodiments can be easily combined without departing from the scope or spirit of this disclosure.

[0016] Additionally, the term "based on" is not exclusive and allows for additional unrecited elements to be based on, unless the context clearly dictates otherwise. Additionally, throughout this specification, the meaning of the singular articles ("a," "an," and "the") includes plural referents. The meaning of "in" includes "in" and "on."

[0017] The present disclosure describes systems and methods for transcatheter surgery. The following aspects provide technical solutions and improvements that overcome technical problems, shortcomings and / or deficiencies in the technical fields including electrosurgery and other transcatheter cardiac surgery. As described in more detail below, the technical solutions and improvements herein include aspects of improved calcification cutting, reduced surgical invasiveness and direct visualization of the surgical field. Based on such technical features, further technical advantages are made available to users and surgeons of these systems and methods. Moreover, various practical examples of the disclosed technology are described, which provide users and surgeons with further practical advantages that are also novel and useful improvements in the art.

[0018] Transcatheter tissue ablation is typically performed using transcatheter electrosurgery, in which radio frequency energy is passed down a guidewire to cut or penetrate tissue within the beating heart or blood vessels. To focus the energy at a specific location in the tissue, the guidewire is insulated except in the area of ​​ablation, and blood is replaced with a non-conductive sterile solution such as dextrose.

[0019] Examples of transcatheter electrosurgery applications to valves include the BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) procedure, the LAMPOON (laceration of the anterior mitral leaflet to prevent left ventricular outflow obstruction) procedure, and the ELASTA-Clip (electrosurgical laceration and stabilization of MitraClip) procedure.

[0020] However, traditional transcatheter electrosurgical ablation has drawbacks, including (1) the inability to cut through calcifications, (2) cumbersome procedures, and (3) the inability to directly visualize tissue.

[0021] The first drawback is that although electrosurgery is effective at cutting through tissue, it is not as effective at cutting through the calcifications commonly found in native and prosthetic valve leaflets.

[0022] A second drawback is that the procedure is cumbersome. To slice the leaflets using this conventional technique, a catheter loop must be made through the leaflets. This requires first using electrosurgery to cut a hole in the leaflet. A second catheter must then be introduced to capture the end of the first catheter that protrudes through the leaflet so that it can be withdrawn from the patient. The V-shaped portion of the first catheter, from which the insulation has been removed, must be pulled through the vasculature until it aligns with the hole in the leaflet. The first catheter must then be pulled on both ends while electricity is applied to slice the leaflet open.

[0023] A third drawback is that only ultrasound and / or fluoroscopy are available, so the tissue is not directly visualized during cutting.

[0024] FIG. 1 illustrates an exemplary transcatheter surgical system 100 for transcatheter surgery, according to one or more embodiments.

[0025] In some embodiments, transcatheter surgery may address or resolve one or more of the above three shortcomings. In some embodiments, when the transcatheter surgery system 100 is a transcatheter laser surgery system, the use of a laser allows for cutting of calcifications. Lasers are effective in cutting both tissue and mineralized deposits found in the body. For example, laser lithotripsy using Holmium:Yag and Thulium fiber lasers may prove to be a very effective technique for breaking up kidney stones, among other mineralized deposits and calcifications.

[0026] The embodiments described herein relate to dissecting tissue. The "tissue" described herein can be any desired tissue. For example, the tissue can be autologous tissue, such as tissue grown or produced by natural tissue growth in a subject animal (e.g., a human or non-human animal). Such tissue can be valve tissue, valve leaflet tissue, cardiac tissue, or other tissue. As another example, the tissue can be non-autologous tissue, such as tissue grown by another animal (e.g., another human or non-human animal) and placed in the subject animal, synthetic tissue (e.g., artificial valve leaflet), or other tissue placed in the subject animal. The tissue can be potentially calcified tissue.

[0027] In some embodiments, transcatheter procedures may be less cumbersome due to the design of one or more catheters used in the transcatheter surgery system 100. In some embodiments, transcatheter procedures may be less cumbersome due to the use of laser surgery. In some embodiments, the transcatheter surgery system 100 may include an energy source 104 that may be coupled to at least one of one or more dissectors 105 and configured to transmit energy to a desired tissue upon activation. In some embodiments, energy transmitted from the energy source 104, for example for transcatheter laser surgery in the heart, may be delivered to a desired tissue via one or more dissectors 105 that may pass through a first catheter 110, i.e., a delivery tube. In some embodiments, the first catheter 110 may pass through a second catheter 101 having an outer sheath 102. In some embodiments, the second catheter 101 and the outer sheath 102 may be steerable and / or rotatable. In some embodiments, the second catheter 101, and in particular the outer sheath 102 of the second catheter 101, may be used to deliver one or more elements, including the first catheter 110, the one or more dissecting devices 105 within the first catheter 110, the working fluid and / or the working volume, to the desired tissue. In some embodiments, saline or another fluid may be passed through the second catheter 101 around the distal end of the outer sheath 102, around the distal end of the first catheter 110, and / or around the distal end 106 of the one or more dissecting devices 105 to drain blood from the contact area between the dissecting device 105 and the tissue. The first catheter 110 may comprise stainless steel, nickel titanium, or any other desired material. In some embodiments, the first catheter 110 may comprise an inner tube and an intermediate sheath, as described in more detail below. Also, in some embodiments, an embolic protection filter may be used to capture any debris that is generated.As used herein, the term "distal" refers to a direction away from the handle of the second catheter 101 (or first catheter 110) from which a user may manipulate the second catheter 101 (or first catheter 110). As used herein, the term "proximal" refers to a direction toward the handle of the second catheter 101 (or first catheter 110).

[0028] The second and third drawbacks of conventional transcatheter electrosurgery are related. Standard catheters and imaging systems are accurate enough to place the catheter tip at the valve leaflet and cauterize the spot to create a hole. However, standard catheter and imaging techniques are not capable of cutting tissue along any line or curve. Standard catheter and imaging techniques only allow for the creation of a cutting line in a direction in which a wire loop can be pulled after passing the hole in the tissue.

[0029] 1 and 2, in some embodiments, the second catheter 101 may be a balloon catheter or any other suitable catheter type. For example, in some embodiments, the second catheter 101 may be a balloon catheter. In some embodiments, the second catheter 101 may include an outer sheath 102 and an expandable balloon 211 formed about and in sealed relation to the outer sheath 102. In some embodiments, the second catheter 101 may include an opening at its distal end that may be directed toward the patient's tissue and allow one or more devices or elements, such as the first catheter 110, to be passed therethrough to the patient's tissue. The opening at the distal end of the second catheter 101 may be at the distal end of the outer sheath 102. In some embodiments, the tissue may include potentially calcified tissue, such as cardiac tissue, including valve tissue (e.g., valve leaflets, annulus, chordae tendineae, etc.) or arterial tissue or other cardiac tissue.

[0030] In some embodiments, the balloon 211 may be located at the distal end of the second catheter 101, near the tissue to be dissected, in a sealed relationship to the outer sheath 102. By being located at the distal end of the second catheter 101 and near the tissue to be dissected, the balloon 211 may be positioned and arranged relative to the second catheter 101 and the tissue to be dissected such that at least a portion of the balloon 211 contacts the tissue when the balloon 211 is inflated. In some embodiments, fluid may be provided to the balloon 211 through the outer sheath 102 to inflate the balloon 211.

[0031] In some embodiments, the first catheter 110 containing the one or more dissecting devices 105 may be advanced through the outer sheath 102 of the second catheter 101 such that the distal end of the first catheter 110 and the distal end 106 of at least one of the one or more dissecting devices 105 move toward or through the distal end of the second catheter 101. In some embodiments, the one or more dissecting devices 105 may be advanced through the outer sheath 102 of the first catheter 110 and the second catheter 101 such that the distal end 106 of at least one of the one or more dissecting devices 105 move toward or through the distal end of the first catheter 110 and the distal end of the second catheter 101. In some embodiments, the proximal end of the one or more dissecting devices 105 may be coupled to the energy source 104. In some embodiments, the energy source 104, when controllably activated, can transmit energy through one or more dissecting devices 105 and out the distal end 106 (or other portion) of the one or more dissecting devices 105, e.g., toward tissue, thereby irradiating the tissue and dissecting the tissue. As used herein, "lacerate" can include puncturing or perforating the tissue of interest. As used herein, "lacerate" can also include slicing or cutting a length of tissue of interest.

[0032] In some embodiments, at least one of the one or more dissecting devices 105 includes an optical fiber, and the energy source 104 includes a laser energy source for transmitting laser energy through the optical fiber. The distal end 106 of the optical fiber may include a fiber tip. In some embodiments, at least one of the one or more dissecting devices 105 includes an electrosurgical wire, and the energy source 104 includes an electrosurgical energy source, such as an RF energy source, for transmitting electrosurgical energy through the electrosurgical wire. The distal end 106 of the electrosurgical wire may include an electrode. In electrosurgical embodiments, the system may be monopolar or bipolar. In a monopolar system, the electrosurgical wire may have one uninsulated electrode thereon (e.g., near its distal end 106) and the patient will have a second electrode attached to the patient at another location or otherwise in contact with the patient, for example attached to the patient's back or buttocks via a patch. In a bipolar system, there may be two electrodes spaced a small distance apart and coupled to one or more electrosurgical wires (e.g., at or near the distal end 106 of the one or more electrosurgical wires), and energy will flow through the tissue between the two electrodes. Thus, in some embodiments, the one or more dissecting devices 105 are one or more electrodes, the energy source is an electrosurgical energy source configured to transmit electrosurgical energy to the tissue to be dissected, and the transmitted electrosurgical energy flows through the tissue from or between the one or more electrodes. In some embodiments, at least one of the one or more dissecting devices 105 may be suitable for transmitting any other desired energy source, including, for example, thermal energy and / or cryogenic energy, and the energy source 104 may be suitable for transmitting any other desired energy to the one or more dissecting devices 105. In some embodiments, at least one of the one or more dissecting devices 105 may be a mechanical dissecting device, such as a sharp blade, which may or may not be coupled to the energy source 104.

[0033] In some embodiments, the transcatheter procedure of the present disclosure may include a steerable catheter system. One or more dissecting devices 105 may be incorporated into the steerable catheter system, thereby combining an energy delivery mechanism with the steerable catheter system. In some embodiments, this combination allows for precise positioning and movement of the one or more dissecting devices 105, e.g., the distal end 106 of the one or more dissecting devices 105, relative to the tissue to be dissected. This feature may allow for dissecting of the leaflets, for example, without the step of forming a wire loop, thereby minimizing the steps required to effectively complete the procedure and making it less invasive. Furthermore, the direction of dissecting is not limited to the direction determined by pulling the loop. For example, typical transcatheter electrosurgery only allows for leaflet dissection in a base-to-tip direction. It may be desirable to dissect the leaflets in a different pattern or to completely ablate the leaflets, which this transcatheter laser dissection allows.

[0034] FIG. 2 illustrates an exemplary catheter tip design of a transcatheter surgical system 100 for transcatheter surgery, according to one or more embodiments.

[0035] In some embodiments, to further improve the safety and effectiveness of tissue dissection, the transcatheter surgery system 100 may include one or more working channels for delivering a working volume at the catheter tip 103 of the second catheter 101 and, in some embodiments, at the distal end of the first catheter 110 to facilitate dissection, evacuation of debris and visualization. The catheter tip 103 may be located at the distal end of the second catheter 101. The first catheter 110 and the catheter tip 103 through which the one or more dissection devices 105 may be delivered may be constructed to include a working volume built into the catheter tip 103 that may surround the one or more dissection devices 105. In some embodiments, the working volume may act to contain the dissection zone from the surrounding blood. This volume may be connected to one or more working channels in the second catheter 101 for irrigation and aspiration. For example, irrigation of a sterile solution such as saline to push blood out and enhance cutting. Aspiration may be used to evacuate the cut debris. In some embodiments, the working volume can enhance imaging of the dissection zone during tissue dissection by sealing the dissection zone from surrounding blood, which is opaque, as described in more detail below.

[0036] In some embodiments, the catheter tip 103 may include an extension member that encloses a working volume behind the tissue layer of tissue to be cut.

[0037] In some embodiments, the catheter tip 103 can be designed in many ways. In some embodiments, the first catheter 110 can include a larger lumen for one or more dissecting devices 105, which can allow saline, glucose or other fluids to flow out of the first catheter 110, for example, at the distal end of the first catheter 110. Alternative designs for the catheter tip 103 include a concentric working channel that provides both irrigation and aspiration (see FIG. 3). Additionally, the catheter tip 103 can include endoscopic imaging to allow visualization during tissue dissection, for example, using a camera 208 and a light emitting diode (LED) 209 for imaging and illumination, respectively. In some embodiments, the optical window 210 for visualization can be a clear solid or a balloon 211 as shown here. FIG. 2A shows the balloon 211 deflated for guidance through the vasculature. FIG. 2B shows that the balloon 211 is inflated to form a larger diameter contact area with the tissue, and the gripping fingers 207 are used to hold the tissue against the optical window 210 during cutting. The tissue gripping fingers 207 may be a rigid cup shape (not shown) to form an enclosed volume around the tissue to be cut. FIG. 2C shows the optical window 210 with the gripping fingers 207 retracted. The tissue gripping fingers 207 may be aligners, described in more detail below, to promote contact between the tissue and the dissecting device 105 to pierce the tissue. In some embodiments, the dissecting device 105 may be advanced through the tissue and the gripping fingers such that the gripping fingers 207 act as aligners during a pushing and / or pulling dissecting procedure, as described in more detail below. In some embodiments, the balloon 211 may center or otherwise precisely position the first catheter 110 and / or the dissecting device(s) 105 within the optical window 210. In some embodiments, the position and orientation of the dissecting device(s) 105 may be fixed relative to the working volume, or the dissecting device(s) 105 may be moveable relative to the working volume.

[0038] In some embodiments, to further improve the safety and effectiveness of leaflet cutting, the first catheter 110 and / or the catheter tip 103 through which the one or more dissecting devices 105 are delivered can be constructed to include an optical imaging device / system, including, for example, a camera 208 and / or an LED 209 integrated into the catheter tip 103, to directly visualize the dissection. In some embodiments, using a clear liquid, such as saline, to fill the working volume can enhance the dissection while still facilitating imaging.

[0039] In some embodiments, to further improve the safety and effectiveness of tissue dissection, the catheter tip 103 through which the first catheter 110 and / or one or more dissection devices 105 are delivered can be constructed to have an extension member with the ability to grasp the leaflet or other tissue using a grasping function or mechanism, such as, for example, the tissue grasping fingers 207 of FIG. 2. In some embodiments, the catheter tip 103 with grasping capabilities can be used to control the movement of the leaflet or other tissue relative to the catheter during dissection, or to control the movement of the catheter relative to the leaflet or other tissue during dissection. In some embodiments, the catheter tip 103 with grasping capabilities can also be used to separate the leaflet or other tissue from the surrounding tissue to allow full thickness cutting of the tissue without damaging the distal surrounding structures.

[0040] In some embodiments, the gripping mechanism may also be used to completely enclose the working volume (e.g., containing the catheter tip 103, surrounding leaflet tissue, gripping mechanism, etc.) to contain fluids and debris associated with the dissection.

[0041] In some embodiments, the transcatheter surgical system 100 may include an embolic protection filter to capture dissection debris that escapes into the blood. In some embodiments, the embolic protection filter may be incorporated into the catheter tip 103, the outer sheath 102, or may be a separate component.

[0042] FIG. 3 illustrates an irrigation and aspiration mechanism incorporated into a catheter tip 103 of a transcatheter surgical system 100 for transcatheter surgery, according to one or more embodiments.

[0043] In some embodiments, the working channels of the catheter tip 103 may provide and remove a working volume of working fluid, for example, for irrigation and aspiration to optimize dissection and debris removal. In some embodiments, (A) and (B) of Figure 3 show two examples of working channels for irrigation and aspiration.

[0044] In some embodiments, FIG. 3A shows the concentric flow path of the working flow path, in which the dissecting device 105, in some embodiments the first catheter 110 and the dissecting device 105, are surrounded by an inner lumen 302 for irrigation and an outer lumen 303 for suction.

[0045] 3A shows an alternative flow path for the working flow path, where the dissector 105, in some embodiments, the first catheter 110 containing the dissector 105, is in a first lumen that is separate from the second lumen 305 for irrigation and the third lumen 306 for aspiration. In some embodiments, in the alternative flow path configuration, each lumen 305 / 306 and the lumen for the dissector 105, in some embodiments, the first catheter 110, are separate openings in the catheter tip 103.

[0046] Although an embodiment has been described herein in which the suction, irrigation and imaging components of system 100 are disposed through the outer sheath and tip 103 of second catheter 101, it should be understood that this is a non-limiting example. For example, first catheter 110 may include any or all of balloon 211, grasping fingers 207, camera 208, LED 209, irrigation lumen 302 / 305 and / or suction lumen 303 / 306, any or all of which may extend through and be deployed from first catheter 110.

[0047] In some embodiments, the transcatheter surgical system 100 may include one or more aligners to promote contact between the one or more dissecting devices 105 and the tissue to be dissected. In some embodiments, the first catheter 110 may include at least one of the one or more aligners. In some embodiments, the second catheter 101 may include at least one of the one or more aligners. In some embodiments, the one or more aligners are deployable and, upon deployment, are adapted to promote contact between the one or more dissecting devices 105 and the tissue. In some embodiments, upon deployment, the one or more dissecting devices 105 may extend outwardly from the first catheter 110 and / or the second catheter 101.

[0048] 4, the first catheter 110 is shown with an aligner 402. Although not shown, it should be understood that the first catheter 110 may be at least partially disposed in the second catheter 101 described in any of the above embodiments. In addition, the first catheter 110 may include an inner tube and an intermediate sheath, as further described below. The aligner 402 may be deployably coupled to the first catheter 110. The aligner 402 may be an expandable balloon, a hinged arm, a deformable portion of the first catheter 110, or any other suitable device or mechanism for maintaining contact between the dissecting apparatus 105 and the tissue 404. Although the tissue 404 is shown in cross-section as a valve leaflet, it should be understood that any other desired tissue may be dissected. One or more control mechanisms may pass proximally through the first catheter 110 to allow a user to selectively deploy the aligner 402. For example, in some embodiments, a fluid flow path may pass through the first catheter 110 to allow inflation or expansion of the balloon aligner 402. In some embodiments, for example, a trigger at the proximal end of first catheter 110 can allow a user to selectively deploy and extend the hinged arms.

[0049] In some embodiments, the first exposed window 406 of the dissecting device 105 and the second exposed window 408 of the dissecting device 105 may allow contact between the dissecting device 105 and the tissue 404. In some embodiments, the first exposed window 406 and the second exposed window 408 are adjacent. In some embodiments, the first exposed window 406 and the second exposed window 408 are disposed in the first catheter 110 as an opening or partial opening in the outer surface of the first catheter 110. For example, in some embodiments, the first exposed window 406 may be disposed as an axial opening at the distal-most end of the first catheter 110 to allow the dissecting device 105 to pass axially distally from the first catheter 110. In some embodiments, as described in more detail below, the second exposed window 408 may be formed as a slot in the radially outer wall of the first catheter 110 to allow the dissecting device 105 to contact the tissue 404 both axially and laterally at the second exposed window 408. In some embodiments, the first exposed window 406 is disposed in the catheter 110 distal to the second exposed window 408 , which is disposed in the catheter 110 distal to the aligner 402 .

[0050] In some embodiments, the dissector 105 may be a single dissector movable through the first catheter 110 such that it is selectively exposable at the first exposure window 406 and / or the second exposure window 408 depending on the distal advancement of the dissector 105 in the first catheter 110. In some embodiments, the first catheter 110 may include two dissectors 105A and 105B. In some embodiments, the first dissector 105A may be exposed through the first exposure window 406 to contact the tissue 404, and the second dissector 105B may be exposed through the second exposure window 408 to contact the tissue 404. In some embodiments, the first dissector 105A and the second dissector 105B may be of the same type. For example, the first dissector 105A and the second dissector 105B may each be an optical fiber for transmitting laser energy or an electrosurgical wire (or electrode) for transmitting electrosurgical energy. In some embodiments, the first dissector 105A and the second dissector 105B may be of different types. For example, the first dissector 105A may be an optical fiber and the second dissector 105B may be an electrosurgical wire (or electrode), or vice versa.

[0051] In some embodiments, at the first exposure window 406, the dissector 105, i.e., the first dissector 105A, may puncture the tissue 404 to form an opening in the tissue 404. In some embodiments, at the second exposure window 408, the dissector 105, i.e., the second dissector 105B, may slice the tissue 404. In some embodiments, with the first catheter 110 at least partially positioned in a hole in the tissue 404 formed by puncturing the tissue 404, as shown in FIG. 4, the first catheter 110 and / or the dissector 105 (or, in some embodiments, the second dissector 105B) may be oscillated axially and moved laterally to slice the tissue 404. In some embodiments, the aligner 402 may be deployed after the first catheter 110 is at least partially positioned in the hole in the tissue 404 formed by the puncture to maintain sufficient contact between the dissecting device 105 (or, in some embodiments, the second dissecting device 105B) and the tissue 404 at the second exposed window 408 to facilitate the desired slicing of the tissue 404.

[0052] Referring now to FIG. 5, another embodiment of the first catheter 110 is shown. In FIG. 5, like reference numerals are used to indicate the same or similar features as detailed with respect to FIG. 4. The first catheter 110 shown in FIG. 5 may be similar in form and function to the first catheter 110 shown in FIG. 4, except as noted herein. Specifically, with reference to FIG. 5, the first exposure window 406 is disposed in the catheter 110 distal to the aligner 402, which is disposed in the catheter 110 distal to the second exposure window 408. As detailed with reference to FIG. 4, the aligner 402 may be deployed after the first catheter 110 is at least partially disposed in the hole in the tissue 404 formed by the puncture to maintain sufficient contact between the dissecting device 105 (or, in some embodiments, the second dissecting device 105B) and the tissue 404 at the second exposure window 408 to facilitate the desired slicing of the tissue 404.

[0053] 4 and 5, the particular design of the first catheter 110 may be selected depending on the particular tissue 404 to be dissected, the particular anatomy of the patient, the angle or direction of approach to the desired tissue to be dissected, etc. In some embodiments, the first catheter 110 of FIG. 4 may be particularly advantageous when dissecting tissue such as a valve leaflet by pushing (i.e., when the catheter 110 is advanced in the direction 412 shown in FIG. 4 to slice the tissue). In some embodiments, the first catheter 110 of FIG. 5 may be particularly advantageous when dissecting tissue such as a valve leaflet by pulling (i.e., when the catheter 110 is advanced in the direction 414 shown in FIG. 5 to slice the tissue).

[0054] Referring to FIG. 6, another embodiment of a first catheter 110 is shown. In FIG. 6, similar reference numbers are used to indicate the same or similar features as detailed with respect to FIG. 4 and FIG. 5. The first catheter 110 shown in FIG. 6 may be similar in form and function to the first catheter 110 shown in FIG. 4 and FIG. 5, except as noted herein. Referring to FIG. 6, the first catheter 110 includes a first aligner 402A and a second aligner 402B. The first exposed window 406 is disposed in the catheter 110 distal to the first aligner 402A, the first aligner 402A is disposed in the catheter 110 distal to the second exposed window 408, the second exposed window 408 is disposed in the catheter 110 distal to the second aligner 402B. The first aligner 402A and the second aligner 402B may be of the same type or different types (e.g., balloon, hinged arms, etc.). The first aligner 402A and the second aligner 402B may be independently deployable or expandable. In some embodiments, when proximal to the tissue 404, the first aligner 402A may be deployed to promote contact between the dissecting device 105 (or, in some embodiments, the first dissecting device 105A) and the tissue 404 at the first exposure window 406 to pierce the tissue 404. In some embodiments, the dissecting device 105 may pierce the tissue 404 at the first exposure window 406 without the deployment of the first aligner 402A. In some embodiments, after deployment for puncturing, the first aligner 402A may be folded or collapsed so that the portion of the first catheter 110 including the first aligner 402A may be advanced through the opening drilled in the tissue 404. In the case of push-through dissection (i.e., in the direction of arrow 412), the second aligner 402B may then be deployed or expanded to promote contact between the dissection device 105 (or, in some embodiments, the second dissection device 105B) and the tissue 404 at the second exposure window 408 to slice the tissue 404.Thus, the first aligner 402A is positioned on the opposite side of the tissue 404 from the second aligner 402B when the second aligner 402B is deployed, or in the case of pulling dissection (i.e., in the direction of arrow 414), after puncturing the tissue 404 and advancing the catheter 110 through the opening in the tissue 404, the first aligner 402A can be deployed or expanded to promote contact between the dissection device 105 (or, in some embodiments, the second dissection device 105B) and the tissue 404 at the second exposure window 408 to slice the tissue 404.

[0055] 7, a perspective view of a first catheter 110 including one or more hinged arms 710 as an aligner 402 is shown. The first catheter 110 is shown including an inner tube 720 and an intermediate sheath 730 surrounding the inner tube 720. The inner tube 720 and the intermediate sheath 730 may be movable relative to each other. The inner tube 720 of the first catheter 110 may include a notch 706 for defining at least a portion of the second exposure window 408. The intermediate sheath 730 of the first catheter 110 may include a notch 732 that may overlap with the notch 706 to define at least a portion of the second exposure window 408. The slitting device 105 may be exposed through the overlapping notches 706, 732. An opening 714 at the distal-most end of the inner tube 720 of the first catheter 110 may define at least a portion of the first exposure window 406. An opening 738 at the distal most end of the intermediate sheath 730 may overlap the opening 714 to at least partially define the first exposure window 406. In some embodiments, the hinged arm or arms 710 may be rotatably coupled to the inner tube 720 of the first catheter 110 by a double pin joint 712. The hinged arm or arms 710 may be rotated outwardly away from the longitudinal axis of the first catheter 110 to deploy or expand. The hinged arm or arms 710 may be rotated inwardly toward the longitudinal axis of the first catheter 110 to collapse. The double pin joint 712 may allow the dissecting device 105 to pass therethrough without shearing the double pin joint 712 and / or the hinged arm or arms 710. For example, the dissecting device 105 may be advanced distally through the openings 714, 738 to puncture tissue, as described above. After puncturing, the dissecting device 105 may be retracted proximally within the first catheter 110 to allow the tissue to fold into the notches 706, 732. The dissecting device may then be advanced distally within the first catheter 110 to slice the folded tissue into the notches 706, 732. This retraction and advancement of the dissecting device 105 may be repeated to slice the tissue along a desired path.For example, in some embodiments, the dissecting device 105 may be oscillated axially within the notches 706, 732 as the first catheter 110 is moved laterally across the leaflet in the desired cutting direction. One or more hinged arms 710 as shown may specifically allow for retrograde dissection of the leaflet.

[0056] 8A-8C, an exemplary method of using the first catheter 110 of FIG. 7 is shown. As detailed with reference to FIG. 2, the balloon 211 can be deployed from the outer catheter 101 to form the optical window 210 (FIG. 2). In addition to having the aforementioned advantages detailed with reference to FIG. 2, the balloon 211 can also assist in maintaining contact between the dissecting device 105 and the tissue 804, such as maintaining contact at a desired location. For example, the balloon 211 can have a profile that, upon expansion, conforms to the shape of at least a portion of the tissue 804 (corresponding to a desired location of the catheter 101). By expanding the balloon 101 and then bringing the tissue 804 into contact with the balloon 211, the balloon 211 can move to a desired location where the profile aligns with the portion, and the movement can cause the balloon 211 to move the catheter 101 to the desired location. However, it should be understood that the balloon 211, although illustrated, is not required for use with the first catheter 110. In FIG. 8A, once the catheter 101 is in the desired position (as a result of the balloon 211), the dissecting device 105 may be advanced distally through the openings 714, 738 (FIG. 7) of the first catheter 110 to puncture the tissue 804. The first catheter 110 may then be advanced through an opening drilled in the tissue 804 with the hinged arm or arms 710 in a collapsed state. After insertion into the opening in the tissue 804, the hinged arm or arms 710 may be deployed outward as shown to maintain contact between the dissecting device 105 and the tissue 804 at the notches 706, 732 (FIG. 7). The first catheter may then be pulled in the direction of the arrow 806 to dissect the tissue 804, as shown in FIG. 8C. While the first catheter 110 described in Figures 7 and 8A-8C includes an inner tube 720 and an intermediate sheath 730, it should be understood that in some embodiments, the first catheter 110 may be defined only by the inner tube 720, and the intermediate sheath 730 may not be incorporated into the first catheter 110.

[0057] Although one or more hinged arms 710 are specifically described with respect to FIG. 7 and FIGS. 8A-8C, it should be understood that the one or more hinged arms 710 are merely one example of the aligner 402. For example, the arms of the one or more hinged arms 710 need not be coupled to the inner tube 110 by double pin joints 712 as shown. Other mechanisms may be used in place of the double pin joints 712 and / or the one or more hinged arms 710. By way of example only, a slider crank may be used to deploy the aligner 402. In some embodiments, the slitting device 105 may be at least a part of a mechanism that is coupled to the aligner 402 and transitions the aligner between the folded and deployed configurations.

[0058] 12A, an embodiment of a first catheter 110 is shown. An aligner 402 may be coupled to the first catheter 110 at a joint 1204. A dissector 105 may be coupled to a control wire 1202 that extends proximally through the first catheter 110. Distal advancement of the control wire 1202 may advance the dissector 105 through a second exposure window 408 in the first catheter 110. A distal end 1206 of the dissector 105 may be coupled to the aligner 402. Thus, distal advancement of the control wire 1202 exposes the dissector 105 through the second exposure window 408 while simultaneously rotating the aligner 402 about the joint 1204, thereby transitioning the aligner 402 from a folded configuration to a deployed configuration. The control wire 1202 may then be moved proximally to retract the dissecting device 105 such that the dissecting device 105 is not exposed through the second exposure window 408 and the aligner 402 transitions from the deployed configuration to the folded configuration.

[0059] 12B, an embodiment of the first catheter 110 is shown. The aligner 402 may be coupled to the first catheter 110 at joint 1224. The dissector 105 may be coupled to the slider 1222. Specifically, a proximal end of the dissector 105 may be coupled to a distal end of the slider 1222 at joint 1226. A distal end of the dissector 105 may be coupled to the aligner 402 at joint 1228. The joints 1224, 1226, and 1228 may be, for example, pin joints. Distal advancement of the slider 1222 may advance the dissector 105 through a second exposed window 408 (FIG. 12A) in the first catheter 110. Upon coupling of the dissecting device 105 to the aligner 402, distal advancement of the slider 1222 exposes the dissecting device 105 through the second exposure window 408 (FIG. 12A) while simultaneously rotating the aligner 402 about the joint 1224, thereby transitioning the aligner 402 from the folded configuration to the deployed configuration. The slider 1222 may then be moved proximally to retract the dissecting device 105 such that the dissecting device 105 is no longer exposed through the second exposure window 408 (FIG. 12A) and the aligner 402 transitions from the deployed configuration to the folded configuration.

[0060] In the embodiment detailed with reference to Figures 12A and 12B, a mechanical mechanism transitions the aligner 402 between the folded and deployed configurations. In some embodiments, the mechanical mechanism may be a hinge mechanism. The dissector 105 may define at least a portion of the mechanical mechanism transitioning the aligner 402 between the folded and deployed configurations. It should be understood that in the embodiment shown in Figures 12A and 12B, a second dissector (e.g., the first dissector 105A shown in Figures 4-6) may be used for exposure through the first exposure window 406 (Figures 4-6). In some embodiments, the dissector 105 detailed with reference to Figures 12A and 12B is an electrosurgical dissector.

[0061] 9, another embodiment of the first catheter 110 is shown. The first catheter 110 may include an intermediate sheath 930 and an inner tube 920. The intermediate sheath 930 may include an opening 902 at its distal end through which the inner tube 920 may be advanced. The opening 902 may be in a distal end wall of the intermediate sheath 930. The inner tube 920 may be at least partially contained within a cannula of the intermediate sheath 930. The inner tube 920 may include a notch 906 in a sidewall of the inner tube 920 that defines a second exposure window 408 through which the slitting device 105 may be exposed. In some embodiments, a portion of the inner tube 920 defines the aligner 402. In some embodiments, a distal-most portion of the inner tube 920 defines the aligner 402. In some embodiments, the aligner 402 may be coupled to or disposed on the inner tube 920 at the distal end of the inner tube. In some embodiments, the aligner 402 may be the deformable portion 910 of the inner tube 920. In some embodiments, the deformable portion 910 may be elastically deformable such that it straightens out (e.g., relative to the longitudinal axis of the notch 906) when disposed within the intermediate sheath 930. In some embodiments, the deformable portion 910 may deform or unfold into a curved shape as shown when advanced distally out of the intermediate sheath 930. In some embodiments, the inner tube 920 includes a straight segment 912 distal to the notch 906 and proximal to the deformable portion 910. The straight segment 912 may be 1 mm or more in length. In some embodiments, the straight segment 912 is 2 mm in length. In some embodiments, the straight segment 912 ensures that the deformable portion 910 is not severed when the dissecting device 105 is moved distally in the notch 906. In some embodiments, the dissecting device 105 can be oscillated axially within the inner tube 920 as the first catheter 110 is moved laterally across the leaflet in the desired cutting direction. An opening 922 can be formed in the distal-most axial surface of the inner tube 920 to define the first exposure window 406.When the deformable portion 910 is straight, the dissecting device 105 may be advanced through the deformable portion 910 and the opening 922 to pierce tissue. The deformable portion 910 may, among other things, allow for antegrade dissection of tissue.

[0062] 10, an exemplary method of using the first catheter 110 of FIG. 9 is shown. As detailed with reference to FIG. 2, the balloon 211 can be deployed from the outer catheter 101 to form the optical window 210 (FIG. 2). In addition to having the above-mentioned advantages detailed with reference to FIG. 2, the balloon 211 can also assist in maintaining contact between the dissecting device 105 and the tissue 1004, as detailed above. With the inner tube 920 disposed within the middle sheath 930, the dissecting device can be advanced distally out of the opening 922 (FIG. 9) to puncture a hole in the tissue 1004. After puncture, the dissecting device 105 can be retracted proximally a certain distance and the inner tube 920 can be advanced out of the middle sheath 930 and through the hole in the tissue 1004 to allow the deformable portion 910 to deploy and bend outward. The dissecting device 105 may then be advanced into the notch 906 (FIG. 9) to slice the tissue 1004. If the first catheter 110 is advanced distally by a pushing action in the direction of the arrow 1010, the deployed deformable portion 910 assists the balloon 211 in maintaining contact between the tissue 1004 and the dissecting device 105. To slice the tissue 1004, the dissecting device may be oscillated within the notch 906 (FIG. 9) as detailed in the previous embodiment. Although the balloon 211 is shown and described as being coupled to the second catheter 101 and functioning as an aligner, it should be understood that the balloon 211 may instead be positioned similarly to the aligner 402 shown in FIG. 4 and coupled to the first catheter 110.

[0063] It should be understood that the embodiment of Figures 4-10 may be combined with any or all of the features detailed with respect to Figures 1-3, if desired. For example, the first catheter 110 detailed may be deployed with a second catheter 101, which may include any or all of the balloon 211, camera 208, LED 209, tissue grasping fingers 207, first lumen 305 / 302 for irrigation, and / or second lumen 306 / 303 for suction. Moreover, it should be understood that one or more components of the second catheter 101, such as the balloon 211 and grasping fingers 207, may be aligners that promote contact between the dissecting device 105 and the tissue to be dissected. Similarly, it should be understood that any or all of the components detailed with respect to the second catheter 101 in Figures 1-3, such as the balloon 211, the camera 208, the LED 209, the tissue grasping fingers 207, the first lumen 305 / 302 for irrigation and / or the second lumen 306 / 303 for suction, may instead be incorporated into the first catheter 110. The embodiment detailed and illustrated with respect to Figures 4-10 may provide several advantages. First, the tool may remain inserted into the hole across the leaflet until the dissection is completed. Second, the tool may assist in maintaining contact between the cardioscope balloon and the leaflet for visualization during cutting. Third, the tool may focus the current and / or laser energy (or other dissection energy) on the tissue in the desired cutting direction. Fourth, the tool may allow glucose or saline infusion around the cutting mechanism.

[0064] In any of the above-described embodiments, the operator may manually control the catheter movement during dissection, but the vibration of the dissector 105 (e.g., mechanical, fiber optic, or electrosurgical wire / electrode) may be motorized. For example, referring to FIG. 11, a transcatheter surgical tool may include a motorized handle. The dissector 105 passes through a valve at the proximal end of the handle and may be secured to a motorized vibration mechanism 1102 using a thumbscrew clamp. A motor unit 1104 couples to the handle via a snap-on / release mechanism so that it can be bagged for sterilization. Based on handle ergonomics and cost, a variety of handle actuation mechanisms may be implemented, including slider crank, voice coil motor with spring return, or pneumatic actuation. A port in the handle may allow pump-based saline or glucose infusion to the cutting tool. A foot pedal control may allow one operator to simultaneously activate the dissector 105 (e.g., fiber optic or electrosurgical wire / electrode), motorized dissector vibration, and saline or glucose infusion.

[0065] In some embodiments, the transcatheter surgical systems and methods are not limited to the specific advantages and procedures described herein, but may include other catheter-tip surgical procedures.

[0066] In some embodiments, control of the transcatheter surgical system 100 and / or components (e.g., the dissecting device 105, catheter tip, gripping mechanism, working volume, steerable catheter system, optical imaging device, or any combination thereof, among others) may be realized by one or more control algorithms executed by one or more computing devices. In some embodiments, the one or more control algorithms may include software that, when executed by one or more computing devices, controls the transcatheter surgical system and / or components to perform procedural actions, for example, automatically, by manual input, or by a combination thereof. In some embodiments, the software may be implemented as instructions stored on a machine-readable medium that may be read and executed by one or more processors. A machine-readable medium may include any medium and / or mechanism for storing or transmitting information in a form readable by a machine (e.g., a computing device). For example, a machine-readable medium may be a read-only memory (ROM); a random access memory (RAM); a magnetic disk storage medium; an optical storage medium; a flash memory device; an electrical, optical, acoustic, or other form of propagated signal (e.g., carrier wave, infrared signal, digital signal, etc.), and the like.

[0067] In some embodiments, one or more computing devices may include a computer engine. In some embodiments, the terms "computer engine" and "engine" refer to at least one software component and / or a combination of at least one software component and at least one hardware component that is designed / programmed / configured to manage / control other software and / or hardware components (e.g., libraries, software development kits (SDKs), objects, etc.).

[0068] Examples of hardware elements may include processors, microprocessors, circuits, circuit elements (e.g., transistors, resistors, capacitors, inductors, etc.), integrated circuits, application specific integrated circuits (ASICs), programmable logic devices (PLDs), digital signal processors (DSPs), field programmable gate arrays (FPGAs), logic gates, registers, semiconductor devices, chips, microchips, chipsets, etc. In some aspects, the one or more processors may be implemented as a complex instruction set computer (CISC) or reduced instruction set computer (RISC) processor; an x86 instruction set compatible processor, a multi-core or other microprocessor or central processing unit (CPU). In various embodiments, the one or more processors may be a dual-core processor, a dual-core mobile processor, etc.

[0069] As used herein, computer-related systems, computer systems, and systems include any combination of hardware and software. Examples of software may include software components, programs, applications, operating system software, middleware, firmware, software modules, routines, subroutines, functions, methods, procedures, software interfaces, application program interfaces (APIs), instruction sets, computer code, computer code segments, words, values, symbols, or combinations thereof. The decision of whether an embodiment is implemented using hardware or software elements may vary according to any number of factors, such as desired computation speed, power levels, thermal tolerance, processing cycle budget, input data rates, output data rates, memory resources, data bus speeds, and other design or performance constraints.

[0070] In some embodiments, the one or more computing devices may include, or be partially or wholly incorporated into, at least one personal computer (PC), laptop computer, ultra laptop computer, tablet, touchpad, portable computer, handheld computer, palmtop computer, personal digital assistant (PDA), mobile phone, combined mobile phone / PDA, television, smart device (e.g., smartphone, smart tablet, or smart television), mobile internet device (MID), messaging device, data communication device, or the like.

[0071] It should be understood that the above-described one or more control algorithms executed by the one or more computing devices may be implemented to control a transcatheter surgical system of any desired cutting mechanism, including, for example, a laser-based cutting mechanism and / or an electrosurgical cutting mechanism.

[0072] The above examples are of course illustrative and not limiting.

[0073] Publications cited throughout this specification are incorporated herein by reference in their entirety. Although one or more aspects of the present disclosure have been described in detail, it is understood that these aspects are merely exemplary and not limiting, and that numerous variations will be apparent to those skilled in the art, including that various aspects of the inventive methodology, exemplary systems and platforms, and exemplary devices described herein may be utilized in any combination with one another. Still further, various steps may be performed in any desired order (and any desired steps may be added or eliminated).

Claims

1. One or more exposed windows; one or more dissecting devices configured to dissect tissue and deployed at or from the one or more exposed windows; and one or more aligners that are deployable and configured, upon deployment, to promote contact between the one or more dissecting devices and the tissue; a catheter for dissecting tissue, comprising:

2. The one or more exposure windows include a first exposure window; the first exposure window is disposed in the catheter to allow one of the one or more lancing devices to puncture tissue and form an opening in the tissue; 10. The catheter of claim 1, wherein a first aligner of the one or more aligners is arranged to, when deployed, promote contact between the tissue and one of the one or more dissecting devices when at least a portion of the catheter is positioned in the opening in the tissue.

3. The one or more exposure windows further include a second exposure window; 3. The catheter of claim 2, wherein the second exposed window is disposed within the catheter such that when one of the one or more dissecting devices is deployed at or from the second exposed window of the catheter, the one of the one or more dissecting devices can slice tissue.

4. The one or more exposure windows include a first exposure window and a second exposure window; One or more slashing devices a first dissecting device advanceable through the catheter such that the first dissecting device is exposable through the first exposure window; and a second dissecting device advanceable through the catheter such that the second dissecting device is exposed through the second exposure window; 10. The catheter of claim 1, comprising:

5. The one or more exposure windows include a first exposure window and a second exposure window; the first exposure window is an axial opening at the distal end of the catheter, and at least one of the one or more dissecting devices is configured to dissect tissue when deployed at or from the first exposure window; 10. The catheter of claim 1, wherein the second exposure window is an opening in a radially outer wall of the catheter, and wherein at least one of the one or more dissecting devices is configured to dissect the tissue when deployed at or from the second exposure window.

6. A catheter as described in any one of claims 1-5, wherein at least one of the one or more cutting devices includes a thulium fiber laser configured to pass laser energy into tissue at or near one or more exposed windows to cut the tissue.

7. A catheter as described in claim 1, wherein at least one of the one or more cutting devices is one or more electrodes configured to pass electrosurgical energy to tissue at or near one or more exposed windows to cut the tissue.

8. The one or more aligners include an aligner rotatably coupled to the catheter; 10. The catheter of claim 1, wherein the one or more dissecting devices include a first dissecting device coupled to the aligner at a distal end of the first dissecting device and coupled to a control wire axially movable within the catheter at a proximal end of the first dissecting device.

9. Distal movement of the control wire within the catheter exposes a first slitting device through a first of the one or more exposure windows and rotates the aligner away from the catheter and into a deployed configuration; 10. The catheter of claim 8, wherein proximal movement of the control wire within the catheter retracts the first dissecting device into the catheter and rotates the aligner into the catheter and into a collapsed configuration. Distal movement of the control wire within the catheter exposes a first length of the first dissecting device through a first exposure window; 10. The catheter of claim 9, wherein the aligner is configured to promote contact between the first length of the first dissecting device and tissue at or near the first exposure window to slice tissue with the first length of the first dissecting device when the aligner is in the deployed configuration.

11. The method of claim 10, wherein the one or more exposure windows include a first exposure window and a second exposure window; the first exposure window is an axial opening at the distal end of the catheter; the second exposure window is an opening in the radially outer wall of the catheter; one or more aligners including an aligner rotatably coupled to the catheter at a position between the first exposed window and the second exposed window; The catheter a control wire axially movable within said catheter; a first dissecting device of one or more dissecting devices exposed through the first exposure window and configured to be advanced through the catheter to puncture tissue; and a second slitting device of the one or more slitting devices, a distal end of the second lancing device coupled to the aligner; a proximal end of the second lancing device coupled to the control wire; Distal movement of the control wire within the catheter exposes the second dissecting device through the second exposure window to slice the tissue and rotates the aligner away from the catheter and into a deployed configuration that promotes contact between the second dissecting device and the tissue at or near the second exposure window; and Proximal movement of the control wire within the catheter retracts the second dissecting device into the catheter and rotates the aligner into the catheter and into a collapsed configuration. Second Slashing Device 10. The catheter of claim 1, further comprising:

12. The method of claim 11, wherein the first dissecting device includes an optical fiber configured to pass laser energy to tissue at or near the first exposed window; 12. The catheter of claim 11, wherein the second dissecting device comprises one or more electrodes configured to pass electrosurgical energy through tissue at or near the second exposed window.

13. One or more exposure windows; one or more dissecting devices configured to dissect tissue and deployed at or from the one or more exposed windows; and one or more aligners that are deployable and configured, upon deployment, to promote contact between the one or more dissecting devices and the tissue when deployed at or from the one or more exposure windows. a catheter comprising: an energy source coupleable to at least one of the one or more dissecting devices and configured to transmit energy to the tissue upon activation, the transmitted energy passing to the tissue through at least one of the one or more dissecting devices deployed at or from the one or more exposure windows; 1. A system for dissecting tissue, comprising:

14. The catheter according to claim 1, wherein the one or more exposed windows include a first exposed window that is an axial opening at a distal end of the catheter; the one or more exposure windows include a second exposure window that is an opening in a radially outer wall of the catheter; the one or more aligners include an aligner rotatably coupled to the catheter; The catheter a control wire axially movable within said catheter; a first dissecting device of one or more dissecting devices exposed through the first exposure window and configured to be advanced through the catheter to dissect tissue; and a second slitting device of the one or more slitting devices, a distal end of the second lancing device coupled to the aligner; a proximal end of the second lancing device coupled to the control wire; Distal movement of the control wire within the catheter exposes the second dissecting device through the second exposure window to dissect the tissue and rotates the aligner away from the catheter and into a deployed configuration that promotes contact between the second dissecting device and tissue at or near the second exposure window; Proximal movement of the control wire within the catheter retracts the second dissecting device into the catheter and rotates the aligner into the catheter and into a collapsed configuration. Second Slashing Device 14. The system of claim 13, further comprising:

15. The method according to claim 1, further comprising: a catheter positionable through the second catheter; and 15. The system of claim 14, wherein the second catheter includes a second aligner configured to promote contact between the first dissecting device and tissue when the first dissecting device is deployed at or from the first exposure window.

16. The method of claim 1, wherein at least one of the one or more slicing devices includes at least one of an optical fiber or one or more electrodes; when at least one of the one or more dissecting devices includes the optical fiber, the energy source includes a laser source configured to transmit laser energy to tissue, wherein the transmitted laser energy passes through the optical fiber to the tissue at or near the one or more exposed windows, dissecting the tissue; 14. The system of claim 13, wherein when at least one of the one or more dissecting devices includes the one or more electrodes, the energy source includes an electrosurgical energy source configured to transmit electrosurgical energy to the tissue, the transmitted electrosurgical energy passing from or between the one or more electrodes to tissue at or near the one or more exposed windows, dissecting the tissue.

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