System and device for repairing cardiovascular tissue

Abstract

Systems and devices are for treating tissue conditions within the cardiovascular system. The systems and devices can be used for excision of tissue or stretching of tissue, especially tissue that is thickened. Many of the systems and devices can include a transcatheter system to deliver a catheter for treating the tissue.

Description

SYSTEM AND DEVICE FOR REPAIRING CARDIOVASCULAR TISSUECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Patent Application No. 63 / 624,630, filed January 24, 2024, the entire disclosure which is incorporated by reference for all purposes.BACKGROUND

[0002] The heart and its valves (e.g., the aortic, pulmonary, tricuspid and mitral valves) sen e critical functions in assuring the forw ard flow of an adequate supply of blood through the cardiovascular system. These heart and its valves can be rendered less effective by structural abnormalities, tissue obstructions, congenital malformations, inflammatory processes, infectious conditions, disease, and functional etiologies. Such damage to the valves can result in serious cardiovascular compromise or death. Treatment for such disorders can be done with the surgical repair or replacement of the valve during open heart surgery’ or with transvascular techniques for introducing and implanting prosthetic devices in a manner that is much less invasive than open heart surgery.

[0003] A healthy heart has a generally conical shape that tapers to a lower apex. The heart has four chambers: the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall generally referred to as the septum.

[0004] One common medical complication is hypertrophic cardiomyopathy (HCM), which is the most common inherited heart disease. HCM is a condition in which the heart muscles are improperly thickened, which can include septal hypertrophy, a localized thickening of the septum. When septal hypertrophy is present, blood flow can be obstructed out of the left ventricle and into the aorta. This condition is referred to as hypertrophic obstructive cardiomyopathy (HOCM). HOCM can cause great stress on the mitral valve, which may result in mitral valve regurgitation. The decrease in blood flow out of the aorta and into the peripheral vascular system can cause the heart muscles to overwork, and can potentially lead to heart failure. Other complications of HOCM include chest pain, shortness of breath, dizziness, palpitations, and ventricular arrhythmia. While most people w ith HOCM have a low risk of sudden cardiac arrest and death, it is the most common cause of sudden cardiac death in individuals under age 35.

[0005] Some techniques for treating septal hypertrophy include septal myectomy and ethanol ablation. Septal myectomy is a surgical procedure to excise tissue from the septum to remove the obstruction. Ethanol ablation is transcatheter procedure in which a catheter is transferred next the thickened septum and ethanol is injected into the septum to kill the tissue, resulting in a shrinkage in size. Although some treatment options exist, there is acontinuing need for improved devices and methods for treating septal hypertrophy and cardiac hypertrophy generally.SUMMARY

[0006] This summary is meant to provide some examples and is not intended to be limiting of the scope of the disclosure in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the feature. Also, the features, components, steps, concepts, etc. described in examples in this summan7and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure can be included in the examples summarized here.

[0007] In some aspects, the techniques described herein relate to a transcatheter system for excising tissue, including: an outer sheath having a proximal-distal axis; and a blade system ensheathed within the outer sheath, the blade system including a set of two or more blades, each blade laterally curved and overlapping another blade on each lateral side such that the set of blades form a tubular shape; the blade system further including an inner san w ich sheath ensheathed within the set of blades; wherein the blade system is capable of moving independently of the outer sheath along the proximal -distal axis; and wherein the set of blades, the inner sandwich sheath, are each capable of moving independently along the proximal-distal axis.

[0008] In some aspects, the techniques described herein relate to a method for excising tissue, including: delivering a transcatheter system to a site of cardiovascular tissue to be excised within a recipient, the transcatheter system including: an outer sheath having a proximal-distal axis; and a blade system ensheathed within the outer sheath, the blade system including a set of two or more blades, each blade laterally curved and overlapping another blade on each lateral side such that the set of blades form a tubular shape; the blade system further including an inner sandwich sheath ensheathed within the set of blades; wherein the blade sy stem is capable of moving independently of the outer sheath along the proximal-distal axis; and w herein the set of blades, the inner sandwich sheath, are each capable of moving independently along the proximal-distal axis; distally advancing the set of blades with the inner sandwich sheath into the tissue yielding a tract of tissue within a lumen of the set of blades; proximally retracting the inner sandwich sheath, allowing a distal tip of each blade to collapse inward such that the distal tip of each blade comes together upon collapsing, encapsulating the tract of tissue therein; and proximally retracting the blade system such that the tract of tissue is excised.

[0009] In some aspects, the techniques described herein relate to a transcatheter system for burrowing into a tissue, including: an outer sheath having a proximal-distal axis; an inner sheath ensheathed within the outer sheath; and a system for burrowing in connection with a distal end of the inner sheath, the system for burrowing including two cooperative elongated tips, wherein the two cooperative elongated tips include a first elongated tip and a second elongated tip, each tip tapering to a point at the distal end; wherein the first elongated tip includes a set of barbs, each barb angled back in the proximal direction; wherein the first elongated tip and the second elongated tip are able to independently move relative to one another along the proximal -distal axis.

[0010] In some aspects, the techniques described herein relate to a method of traversing a catheter through a tissue, the method including: delivering a transcatheter system to a site of tissue, the transcatheter system including: an outer sheath having a proximal-distal axis; an inner sheath ensheathed w ithin the outer sheath; and a burrowing system including: two cooperative elongated tips in connection with a distal end of the inner sheath, w herein the tw o cooperative elongated tips include a first elongated tip and a second elongated tip, each tip tapering to a point at the distal end, w herein the first elongated tip includes a set of barbs, each barb angled back in the proximal direction, and wherein the first elongated tip and the second elongated tip are able to independently move relative to one another along the proximal-distal axis; a spring within a compartment at the proximal end of the second elongated tip, the spring also in contact with the proximal end of the first elongated tip; and a line in connection with the proximal end of the first elongated tip and extending in the proximal direction; distally advancing the burrowing system to traverse into the tissue; and incrementally distally advancing the burrowing system to traverse deeper into tissue.

[0011] In some aspects, the techniques described herein relate to a dual transcatheter system for excising and repairing tissue, the system including: an outer sheath having a proximal-distal axis, the outer sheath including an elongated aperture at a distal end of the outer sheath and a closed distal tip; a tissue mass excision system within the outer sheath and capable of excising tissue through the elongated aperture, the tissue mass excision system including a tool with a sharp edge and a compartment capable of capturing excised tissue therein; and a suturing system situated within the elongated aperture, the suturing system including a plurality of needles, each needle having a needle tip and an inner lumen with a traversing suture within the inner lumen, w herein each of the needles are attached to a needle holder that is an elongated rod.

[0012] In some aspects, the techniques described herein relate to a method for excising and repairing tissue, the method including: advancing a transcatheter system to a site to tissue to be excised, wherein the transcatheter system includes an outer sheath, a tissue massexcision system, a suturing system, and a suturing driver; wherein the outer sheath includes an elongated aperture at a distal end, a closed distal tip, and a final suture channel; wherein the tissue mass excision system is within the outer sheath and capable of excising tissue through the elongated aperture, and w herein the tissue mass excision system including a tool with a sharp edge and a compartment capable of capturing excised tissue therein; wherein the suturing system is situated within the elongated aperture and includes a plurality needles, each needle having a needle tip and an inner lumen with a traversing suture within the inner lumen, wherein each of the needles are attached to a needle holder that is an elongated rod, and w herein each traversing suture has first suture loop on one end of the suture and second suture loop on another end of the suture; and wherein the suturing driver is situated proximally positioned relative to the suturing the system, wherein the suturing driver includes a torqueing rod that is in connection with the needles via the needle holder; situating the elongated aperture, the tissue mass excision system, and suturing system over the site of tissue; excising a mass of tissue using the tissue mass excision system; and repairing tissue remaining adjacent to the tissue mass that was excised.

[0013] In some aspects, the techniques described herein relate to a system for stretching tissue, including: a first strut; a second strut connected to the first strut via a hinge; a first anchor in connection wdth a peripheral end of the first strut; and a second anchor in connection with a peripheral end of the second strut.

[0014] In some aspects, the techniques described herein relate to a method for stretching tissue, including: positioning a stretching system over a tissue to be stretched, wherein the stretching system includes: a first strut, a second strut connected to the first strut via a hinge, a first anchor in connection with a peripheral end of the first strut, and a second anchor in connection wdth a peripheral end of the second strut; anchoring the stretching system over the tissue to be stretched via the first anchor and the second anchor; straightening the hinge to at or about 180°; and locking the hinge in the straightened position.

[0015] In some aspects, the techniques described herein relate to a system for stretching tissue, including: a first strut; a second strut, wherein the first strut and the second strut crossover; a pivot positioned where the first strut and the second strut crossover; a set of four anchors, each anchor at an end of the first strut and at an end of the second strut; and a set of perimeter struts wdth a means for elongating or shortening, the set of perimeter struts connect one end the first strut wdth one end of the second strut.

[0016] In some aspects, the techniques described herein relate to a method of stretching tissue, including: positioning a stretching system over a tissue to be stretched, wherein the stretching system includes: a first strut, a second strut, wherein the first strut and the second strut crossover, a pivot positioned where the first strut and the second strut crossover, a setof four anchors, each anchor at an end of the first strut and at an end of the second strut, and a set of perimeter struts with a means for elongating or shortening, the set of perimeter struts connect one end the first strut with one end of the second strut; anchoring the stretching system over the tissue to be stretched via the set of four anchors; and elongating the stretching system in one dimension using the means for elongating or shortening.

[0017] In some aspects, the techniques described herein relate to a transcatheter system that extends along a proximal-distal axis for excising tissue, including: a controller, a perimeter blade system, a traversing blade system, a grasper, and a sheath, wherein the sheath ensheathes the perimeter blade system, the traversing blade system, and the grasper; wherein the grasper includes sharp piercing tip at its distal end and is configured to grasp tissue; wherein the perimeter blade system includes one or more perimeter blades, each perimeter blade in connection w ith the controller via a perimeter-blade torqueing connector, wherein the perimeter blade system is peripheral to the grasper within the sheath and each perimeter blade is configured to encircle the grasper via the perimeter-blade torqueing connector; w herein the traversing blade system includes one or more traversing blades, each traversing blade in connection with the controller via a push-wire connector, wherei n the traversing blade system is peripheral to the grasper within the sheath and each traversing blade is configured traverse across a plane that is orthogonal to the proximal-distal axis.

[0018] In some aspects, the techniques described herein relate to a method for excising tissue using a transcatheter system that extends along a proximal-distal axis, including: delivering the transcatheter system to a site of cardiovascular tissue to be excised within a recipient, the transcatheter system including: a controller, a perimeter blade system, a traversing blade system, a grasper, and a sheath, wherein the sheath ensheathes the perimeter blade system, the traversing blade system, and the grasper; wherein the sheath ensheathes the perimeter blade system, the traversing blade system, and the grasper; w herei n the grasper includes sharp piercing tip at its distal end and is configured to grasp tissue; wherein the perimeter blade system includes one or more perimeter blades, each perimeter blade in connection with the controller via a perimeter-blade torqueing connector, w herein the perimeter blade system is peripheral to the grasper within the sheath and each perimeter blade is configured to encircle the grasper via the perimeter-blade torqueing connector; w herein the traversing blade system includes one or more traversing blades, each traversing blade in connection with the controller via a push-wire connector, w herei n the traversing blade system is peripheral to the grasper within the sheath and each traversing blade is configured traverse across a plane that is orthogonal to the proximal-distal axis; distally advancing the grasper into the tissue; distally advancing the perimeter blade system into the tissue; distally advancing the traversing blade system into the tissue such that eachtraversing blade traverses through tissue in a direction orthogonal to the proximal-distal axis; rotating the perimeter blade and traversing blade such that it cuts through the tissue; proximally retracting the torqueing connector such that the tissue is excised.

[0019] Any of the above systems, devices, apparatuses, components, etc. can be sterilized (e.p., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use w ith patients, and the above methods can comprise (or additional methods consist of) sterilization of one or more systems, devices, apparatuses, components, etc. herein (e.c / ., w ith heat, radiation, ethylene oxide, hydrogen peroxide, etc.).BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The description and claims will be more fully understood with reference to the following figures, w hich are presented as examples of the disclosure and should not be construed as a complete recitation of the scope of the disclosure.

[0021] Fig. 1 provides a view' of a heart.

[0022] Fig. 2 provides a view of a heart with thickened tissue.

[0023] Figs. 3A to 3C provide view s of an example of a catheter system to excise tissue.

[0024] Figs. 4A to 4K provide views of an example of a method to excise and repair tissue.

[0025] Figs. 5A to 5C provide views of an example of a catheter system to burrow into tissue.

[0026] Figs. 6A and 6B provide views of a mechanism to burrow into tissue using an example of a catheter system.

[0027] Figs. 7A to 7F provide views of an example of a method to burrow- into and ablate tissue.

[0028] Figs. 8A and 8B provide views of an example of a dual system to excise and repair tissue.

[0029] Figs. 9A and 9B provide view s of an example of a torque system and to control a suture system as part of the dual system to excise and repair tissue.

[0030] Figs. 10A to 10D provide v iew s of an example of a tissue mass excision system and a suture system as part of the dual system to excise and repair tissue.

[0031] Figs. 11A1 to 11K provide view of an example of a method to excise a mass of tissue and repair the site of excision.

[0032] Figs. 12A and 12B provide views of an example of a system to stretch tissue using a hinge.

[0033] Figs. 13A and 13B provide views of an example of a method to stretch tissue using a system with a hinge.

[0034] Figs. 14A and 14B provide views of an example of a system to stretch tissue using a pivot and a means for elongating or shortening.

[0035] Figs. 15A and 15B provide views of an example of a coring system to excise tissue.

[0036] Figs. 16A to 16E provide views of an example of a method to core into tissue and excise the tissue.DETAILED DESCRIPTION

[0037] The current disclosure details systems and devices for thinning of thickened tissues. The systems and devices can utilize a catheter design for minimal invasiveness and / or travel through the circulatory within the body. Accordingly , systems and devices can comprise a catheter that provides a means for translocating tools for thinning thickened cardiovascular tissue. The thinning of thickened tissues can reduce cardiac hypertrophy and / or can improve blood flow. The systems, devices, and methods described herein can be utilized as an independent treatment or utilized in a combination with any other compatible treatment for valve regurgitation.

[0038] Some of the systems and devices of the current disclosure are directed to excising tissue with a set of cooperative blades, which can comprise a catheter-based blade system and a system to capture excised tissue. Some of these systems further include a means for repair of the remaining native tissue after tissue excision. These systems and devices can be utilized to reach a site of tissue to be excised via a catheter delivery system comprising the blade system and the system for capturing excised tissue. In some implementations, the blade system is advanced distally out of an outer sheath to cut a tract of tissue. In some implementations, a system is provided for capture the cut band of tissue. In some implementations, a system of tissue repair is also provided, the system comprising an anchor and suture for repair.

[0039] Some of the systems and devices of the current disclosure are directed to a system for burrowing into a tissue, which can comprise a catheter-based burrowing tip for generating a tract within tissue, such that a catheter-based device can traverse the tissue via the generated tract. These systems and devices can be utilized to reach a tissue via a catheter delivery system comprising a burrowing system. In some implementations, the burrowing system utilizes an incremental “dig-and-grasp” mechanism to burrow into a tissue. Upon completion of burrowing, the burrowing catheter can be utilized as a guide to allow anothercatheter to reach an intratissue site. In some implementations, an ablation catheter is utilized to ablate the tissue along the tract generated by the burrow ing catheter. In some implementations, the burring catheter is delivered to a thickened tissue to burrow therein and an ablation catheter is utilized to ablate the tissue such that the tissue is thinned.

[0040] Some of the systems and devices of the current disclosure are directed to a dual system for excision of a tissue mass and repair of native tissue, which can comprise a catheter-based delivery system. The catheter-based delivery system can deliver a tool for excising a tissue mass and suture system for repairing the tissue. In some implementations, the system for excising tissue comprises a tool with sharp edge which include a means for capturing the excised tissue. In some implementations, the excision tool comprises a compartment and a sharp edge of that provides the means excising tissue, which can be capture the excised mass within the compartment. In some implementations, the excision tool is utilized with a suturing system, the suturing system providing a means for suturing the remaining tissue after excision. In some implementations, the catheter-based device is utilized to remove a mass of thickened and repair the native tissue such that the tissue is thinned.

[0041] Some of the systems and devices of the current disclosure are directed to a system for flattening an area of thickened tissue, which can comprise a mechanical system for flattening tissue. These systems and devices can be installed on a tissue that is to be flattened, the device can be anchored to the tissue, and a mechanical means is utilized to stretch and flatten the tissue. In some implementations, the mechanical system for flattening tissue is a bar with a hinge and component that can lock the hinge in straightened position. In some implementations, the mechanical system for flattening tissue is a crossbar w ith a pivot at the cross and a means to stretch the area of the crossbar in at least one direction, flattening tissue as the crossbar is expanded.

[0042] Some of the systems and devices of the current disclosure are directed to excising tissue with a set of opposing paddle blades, which can comprise a catheter-based blade system and a system to capture excised tissue. Some of these systems further include a means for repair of the remaining native tissue after tissue excision. These systems and devices can be utilized to reach a site of tissue to be excised via a catheter delivery system comprising the paddle blade system and the system for capturing excised tissue. In some implementations, the paddle blade system is advanced distally out of an outer sheath to cut a tract of tissue. In some implementations, a system is provided for capture the cut band of tissue.

[0043] The described systems, devices, and methods should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and nonobviousfeatures and aspects of the various disclosed systems and devices, alone and in various combinations and sub-combinations w ith one another. The disclosed systems, devices, and methods are not limited to any specific aspect, feature, or combination thereof, nor do the disclosed systems, devices, and methods require that any one or more specific advantages be present or problems be solved.

[0044] Various examples of reducing tissue profile are disclosed herein, and any combination of these examples can be made unless specifically excluded. For example, a three-blade system can be combined w ith a dig-and-grasp burrowing system, even if a specific combination is not explicitly described. Likewise, the different constructions and features of systems for reducing tissue profile can be mixed and matched, such as by combining the various components of the systems, even if not explicitly disclosed. In short, individual components of the disclosed systems can be combined unless mutually exclusive or physically impossible.

[0045] Although the operations of some of the disclosed methods are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show- the various ways in which the disclosed methods, systems, and apparatus can be used in conjunction with other systems, methods, and apparatus.

[0046] Further, the techniques, methods, operations, steps, etc. described or suggested herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with the body parts, tissue, etc. being simulated), etc.

[0047] The terms “proximal” and “distal” as used throughout the description relate to a catheter system axis, in which the end w-here the procedure is performed is the distal end and the opposite end where the catheter system is controlled is the proximal end. Accordingly, the distal end of the catheter system is the leading end that first traverses into the body and first reaches the procedure site. Conversely, the proximal end of the catheter system is the portion that remains extracorporeal. Likewise, a distal movement along the catheter axis would be movement of a component in a direction towards a site of procedure and a proximal movement along the catheter axis would be movement of a component in an opposite direction. Although these terms have a relationship with a site of procedure, it is to be understood that these terms are used for reference and the site of procedure does not need to be present when interpreting the components or movements of the devices and systems described herein.

[0048] Various systems and devices for tissue repair are utilized for the purpose of performing a procedure within a recipient (i.e., entity receiving the transcatheter procedure). Recipients include (but are not limited to) patients, animal models, cadavers, or anthropomorphic phantoms. Accordingly, in addition to methods of treating patients, the systems and devices can be utilized in training or other practice procedures upon animal models, cadavers, or anthropomorphic phantoms.

[0049] The described systems and devices can be sterilized, which can be performed using gamma irradiation, gas plasma, aldehydes, ethylene oxide, and / or e-beam. The systems or devices can be further treated with a formaldehyde bioburden reduction process. After preparation, the systems and devices can be stored wdthin a container, w hich can be hermetically sealed or otherwise kept sterile.

[0050] Fig. 1 is a coronal-plane Anew of the heart sectioning through the heart such that the four chambers and the four valves of the heart can be viewed. The right ventricle (RV) and the right atrium (RA) are separated from the left ventricle (LV) and the left atrium (LA) via the ventricular septum (VS) and atrial septum, respectively. The four heart valves direct flow between the four chambers. The right side of the heart includes the tricuspid valve (TV) separating the RA from the RV. The blood from the RV is pumped through the pulmonary valve (PV) into the pulmonary trunk (PT) and lungs. The left side of the heart includes the mitral valve (MV) separating the LA from the LV. The blood from the LV is pumped through the aortic valve (AV) into the aortic arch (AA) and throughout the body.

[0051] When operating properly, the leaflets of each valve can open and close in a manner that allows blood to flow only in one direction. The right atrium receives unoxygenated blood returning from the peripheral vascular system via the superior vena cava (SVC) and inferior vena cava (IVC). When the muscles of the RA contract and the RV dilates, the deoxygenated blood that is collected in the RA flows into the RV via the TV. When the muscles of the RA relax and the muscles of the RV contract, the increased blood pressure in the RV urges the leaflets of the TV to coapt together, thereby closing the valve so that blood cannot flow back to the RA and is instead expelled out of the RV through the PV into the lung capillaries where the hemoglobin of the red blood cells are oxygenated.

[0052] The LA receives oxygenated blood from the pulmonary veins (LUPV and LLPV). When the muscles of the LA contract and the LV dilates, the oxygenated blood that is collected in the LA flows into the LV via the mitral valve. When the muscles of the LA relax and the muscles of the LV contract, the increased blood pressure in the LV urges the two leaflets of the mitral valve to coapt together, thereby closing the valve so that blood cannot flow back to the LA and is instead expelled out of the LV through the AV and into the peripheral vascular system.

[0053] Fig-2provides a coronal-plane view of an example of a heart having thickened tissue. The example shows a thickened septum. In addition, the right ventricular wall, the left ventricular wall, and the vertex are also thickened. The thickening of these tissues can arise due to various ailments and pathologies, which can be congenital or noncongenital. For instance, in some patients, hypertrophic cardiomyopathy can be hereditary. In some patients, hypertrophy can arise due to prolonged poor cardiovascular health. Despite the cause of thickened tissue, the hypertrophic state of the tissue can obstruct or otherwise disrupt blood flow, which can lead to other complications such as valvular regurgitation and / or heart failure. One method to improve cardiovascular health is to remove some of the thickened tissue such that the tissue is thinned, which can help restore adequate and proper blood flow.

[0054] Systems and devices for excision of tissue can comprise a catheter system such that it can be utilized w ithin minimally invasive procedures and / or traverse through the circulatory’ system to reach the site of procedure. The systems and devices can comprise a delivery catheter for delivery’ of a set of cooperative blades for excising and grasping tissue that is in connection w ith a controller system at the proximal end, which can be utilized to control the delivery catheter and the systems and devices for excision. In some implementations, delivery catheter systems and devices can further comprise a means for repairing the native tissue at the site of excision.

[0055] The systems and devices for excision of tissue can be utilized on any tissue, but especially on thickened tissue within the cardiovascular system. Any transcatheter approach can be utilized to reach the tissue to be excised, such as (for example) a transfemoral, subclavian, transapical, transjugular, or transaortic approach.

[0056] In some implementations, the system for excising tissue comprises a catheterbased blade system and a system to capture excised tissue, which can be controlled by the proximal controller system. In some implementations, the blade system comprises a set of cooperative blades that laterally curve and laterally overlap forming a tubular or conical shape, with the distal edge of each blade comprising a sharp edge configured to cut through tissue. In some implementations, each blade is curved such that each blade is concentric. In some implementations, the width of each blade can taper towards the distal end. In some implementations, the width of the blade tapers to form a pointed or rounded vertex at the distal end. Each blade can be set with an inward push force such that the blades collapse inward on one another, especially the distal end of each blade to transition from a tubular shape to a conical shape. In some implementations, the blades are constructed with a shapememory material and memory-fixed to provide the inward collapsing push force. Any shapememory material can be utilized, such as (for example) nitinol.

[0057] The set of blades can comprise at least two blades, and up to as many blades capable of fitting within a delivery catheter system. In various implementations, the set of blades comprises two blades, the set of blades comprises three blades, the set of blades comprises four blades, the set of blades comprises five blades, the set of blades comprises six blades, the set of blades comprises seven blades, the set of blades comprises eight blades, or the set of blades comprises more than eight blades. The set of blades can overlap and / or form one or more layers to yield the tubular and conical shapes.

[0058] In some implementations, the system and devices for excising tissue comprises an outer sheath and a blade system, each of which can be controlled by the proximal controller system. In some implementations, the blade system comprises the set of blades, an outer sandwich sheath that encircles and surrounds the set of blades, and an inner sandwich sheath that is encircled by and surrounded by the blades. The outer sandwich sheath can ensheathe the sharp blades to prevent undesired exposure of the sharp edges. The inner sheath can provide a means to prevent the preloaded memory-fixed blades from collapsing inward.

[0059] Using the set of sharp edges as a leading edge, the set of blades can be distally advanced out of the outer sheath and into tissue, cutting a tract of tissue as it is advanced. As the set of blades is distally advanced, the inner sandwich sheath and / or outer sandwich can prevent inward collapse and can support the blades such that the set of blades maintains a tubular shape with rigor. Upon reaching a distance of distal advancement within the tissue, the inner sandwich sheath can be proximally retracted, allowing the distal end of each preloaded memory-fixed blades to collapse inward, in which the set of blades cooperatively capture the excised tissue by transitioning to the conical shape. Proximally retracting the collapsed set of blades removes the excised tissue.

[0060] In some implementations, the system and devices for excising tissue comprises a means for suturing and repairing the native tissue at the site of excision, which can be controlled by the proximal controller system. In some implementations, a suture system comprises a hollowed helix, an anchor, and suture. The anchor can have a sharp tip and can be positioned at the distal end of the hollowed helix. The suture can be attached to the anchor tip and can extend within the lumen of the hollowed helix. In some implementations, in order to repair a site of excision, the hollowed helix and anchor tip of the suture system can be rotated like a corkscrew such w hile it distally advances within the native tissue around the excision site. In some implementations, upon reaching the distal end of the excision site, the anchor is anchored within the native tissue and the suture system can be rotated in a direction such that it proximally retracts out of the native tissue. As the hollow ed helix proximally retracts, the suture attached to the anchor is left behind and thus is left threadedit h in the native tissue and around the area where the tract of tissue was removed. Upon removing the helix from the native tissue, the suture can be tightened and secured.

[0061] Provided in Fig. 3A is an exploded view of an example implementation of a catheter-based tissue excision system. As depicted in this example, the catheter-based excision system comprises an outer sheath 301, a blade system 303, and a suture system 305, each of which extend along the distal-proximal axis of the catheter-based excision system and controlled by a proximal controller system. Outer sheath 301 is the most outer layer of the catheter-based excision system. As shown, blade system 303 is the most inner layer of the catheter-based excision system and suture system 305 is provided in between outer sheath 301 and the blade system. Outer sheath 301, blade system 303, and suture system 305 are each capable of individually being advanced distally and retracted proximally, which can be controlled via a catheter control system provided at the proximal end of the catheterbased excision system. In some implementations, the catheter-based excision system does not include suture system 305, as the act of post-excision suturing can be optional and / or performed by a different means.

[0062] Provided in Fig. 3B is an exploded view of blade system 303, which comprises a set of three blades 307, an outer sandwich sheath 309, and inner sandwich sheath 311, each of which extend along the distal-proximal axis of the catheter-based excision system. As depicted, outer sandwich sheath 309 encircles and surrounds the set of blades 307, and inner sandwich sheath 3ti is encircled by and surrounded by the set of blades. Each blade 313 of the set of blades 307 has a curved contour and laterally overlaps with a portion of an adjacent blade such that the set of blades forms a tubular or conical shape. As shown, the lateral edge 315 of each blade tapers towards the distal tip 317 of the blade, forming a vertex at the distal dip. Each blade is memory-fixed to provide a preloaded force such that distal tip 317 of each blade will collapse tow ards the center of the tubular shape. When the blades collapse inward, the distal tip 317 of each blade can come together such the set of blades form a conical shape (see Fig. 4D and accompanying description for more detail). Inner sandwich sheath 311 can be utilized to prevent distal tip 317 of each blade from collapsing inw ard w hen extended to or near the distal end of the set of blades 307.

[0063] Provided in Fig. 3C is an exploded view of suture system 305, w hich comprises a helical coil 319, an anchor 321, and a suture 323, each of which extend along the distal- proximal axis of the catheter-based excision system. As depicted, helical coil 319 contains a hollowed inner lumen 325. Anchor 321 can comprise a sharp tip 327 which can be utilized to traverse through tissue when the helical coil is turned like a corkscrew to distally advance therethrough. Anchor 321 can also include one or more barbs 329, which can help prevent the anchor from proximally retracting. In connection with anchor 321 is suture 323, which iscontained within and extends along inner lumen 325. Suture system 305 can also comprise a pusher 331, which can also be contained within and extend along inner lumen 325. Pusher 331 can provide a push force to push to help anchor situate within a tissue and / or prevent the anchor from proximally retracting w hen helical coil 319 is retracted.

[0064] While a specific configuration of a catheter-based excision system is described above w ith reference to Figs. 3A to 3C, it should be readily appreciated that various configurations of the system can be implemented in any of a variety of combinations of components. Accordingly, the specific configuration of the system described herein should be understood as not to be limited to any specific configuration, but instead can be implemented in any configuration capable of excising tissue via catheter system.

[0065] Provided in Figs. 4A to 4K is an example of a method to use a catheter-based excision system. In this example, the catheter-based excision system as depicted in Figs. 3A to 3C is utilized, but it is to be understood that various features or components of the system can be exchanged or altered for features or components capable of performing equivalent or similar tasks. For example, although the blade system utilizes three blades, any number of blades can be utilized to perform the excision. In addition, the various features or components of the system can be exchanged or altered for features or components to perform alternative tasks within the provision of tissue excision, as would be understood in the art. For example, the suture system can be exchanged with a different suture system or a tissue stapling system, as would be understood in the art.

[0066] Fig. 4A depicts the catheter-based excision system reaching tissue 401 to be excised. The distal end of outer sheath 301 distal end is translocated and positioned adjacent to the tissue 401. Within outer sheath 301 is blade system 303 and suture system 305.

[0067] Fig. 4B depicts the distal advancement of the blade system 303 into tissue 401 to be excised. Outer sheath 301 is maintained at its position adjacent to tissue 401. The distal tip 317 of each blade 307 along with inner sandwich sheath 311 is distally advanced 402 into the tissue. The set of blades 307 can optionally be rotated 404 in a clockwise and / or a counter-clockwise direction such that the lateral edge of each blade cuts through tissue 401. Inner sandwich sheath 311 is distally advanced along with the set of blades 307 to provide support to the blades to prevent collapsing of the distal tips of the blades, ensuring the blades maintain a tubular shape. Outer sandwich sheath 309 can slightly penetrate tissue 401, which can provide some support to the set of blades 307 as it is distally advanced. Suture system 305 remains within outer sheath 301.

[0068] Fig. 4C depicts further distal advancement of the blade system 303 into tissue 401. Outer sheath 301 is still maintained at its position adjacent to the tissue. The distal tip317 of each blade 307 along w ith inner sandwich sheath 311 has been further distally advanced 406 into the tissue to generate a tract of tissue 401 within the lumen of the set of blades 307. Inner sandwich sheath 311 is further distally advanced along with the set of blades 307 to provide support to the blades to prevent collapsing of the distal tips of the blades, ensuring the blades maintain a tubular shape. Suture system 305 remains within outer sheath 301.

[0069] Fig. 4D depicts the proximal retreat of inner sandwich sheath 311 resulting in the collapse of distal tip 317 of each blade 307. Outer sheath 301 is maintained at its position adjacent to the tissue. Upon reaching a distance within the tissue, the set of blades 307 are not advanced further. At this point, inner sandwich sheath 311 is proximally retreated and the preloaded force of the set of blades 307 results in distal tip 317 of each blade to collapse inw ard to transition from a tubular shape to a conical shape resulting in the set of blades having encapsulated the tract of tissue 401 therein. Rotating the set of blades 307 in a clockw ise and / or a counterclockw ise direction can assist the inw ard collapse of distal tip 317 as the lateral edge of each blade cuts through the tissue. Suture system 305 remains within outer sheath 301.

[0070] Fig. 4E depicts the distal advancement of optional suture system 305. The distal advancement of suture system 305 can be performed prior to, concurrently with, or subsequent to the distal advancement of the blade system. Outer sheath 301 is maintained at its position adjacent to the tissue. Upon the inward collapse of distal tip 317 of each blade 307, suture system 305 via helical coil 319 is rotated 408 while being distally advanced. As suture system 305 is distally advanced, sharp tip 327 of anchor 321 provides the means for traversing through peri-tract tissue 403 (e.t / ., the tissue adjacent to and surrounding the tract of tissue 401 to be excised). Suture system 305 is distally advanced to or near the inner end of tissue tract 401.

[0071] Fig. 4F depicts the proximal retrieval of blade system 303. Outer sheath 301 is maintained at its position adjacent to the tissue. Upon suture system 305 distally advancing to or near distal tip 317 of set of blades 307, the blade system 303 is proximally retracted 410 with the distal tip 317 of each blade remaining collapsed and tract of tissue 401 encapsulated therein. As blade system 303 is proximally retracted, outer sandwich sheath 309 and inner sandwich sheath 311 can maintain its relative position to the set of blades 307, providing support to the set of blades. Suture system 305 is proximally retracted back such that it is contained within the lumen of outer sheath 301.

[0072] Fig. 4G depicts the securement of anchor 321 within the peri-tract tissue 403. Fig. 4H provides a magnified view of the securement of anchor 321 within the peri-tract tissue 403. Fig. 4G further depicts the initial proximal retraction of the suture system. Theproximal retraction of the suture system can be performed prior to, concurrently with, or subsequent to the proximal retrieval of the blade system. Outer sheath 301 is maintained at its position adjacent to the tissue. Blade system 303 has been proximally retracted further within outer sheath 301. To secure anchor 321, pusher 331 releases the anchor from helical coil 319 and pushes the anchor into the peri-tract tissue 403. Barbs 329 help hold and secure anchor 321 within the peri-tract tissue 403. With anchor 321 secured w ithin the tissue, helical coil 319 is proximally retracted by rotating back through the tissue. Suture 323 is in connection with anchor 321, resulting in the suture remaining w ithin the peri-tract tissue 403 as the helical coil 319 is proximally retracted. Pusher 331 can be a flexible rod with an appropriate tensile strength to push and / or hold an anchor within the tissue as the helical coil 319 is proximally retracted.

[0073] Fig. 4I depicts further proximal retraction of helical coil 319 and the initial gathering of the peri -tract tissue. Outer sheath 301 is maintained at its position adjacent to the tissue. Helical coil 319 is further proximally retracted by rotating back through the tissue. As helical coil 319 is proximally retracted, suture 323 is tightened. Because suture 323 is in connection with anchor 321, the tightening of the suture results in the peri-tract tissue 403 to be gathered, sealing the cavity created by the removal of the tract of tissue 401.

[0074] Fig. 4J depicts complete proximal retraction of helical coil 319 out of the tissue and the gathering of the peri-tract tissue. Outer sheath 301 is maintained at its position adjacent to the tissue. Helical coil 319 is further proximally retracted by rotating back through the tissue and back into outer sheath 301. Suture 323 is tightened until taut. The tightening of suture 323 gathers peri-tract tissue 403, resulting in closure of the gap of tissue created by the removal of the tract of tissue 401.

[0075] Fig. 4K depicts securement of suture 323 and removal of the catheter system.Suture 323 can cut and secured to the peri-tract tissue 403. Securement can be achieved by any means for securing a suture, such as (for example) knotting the suture or using a cinch pledget. The catheter system is proximally retracted back out of the recipient.

[0076] While a specific configuration and method of use of a catheter-based excision system is described above with reference to Figs. 4A to 4K, it should be readily appreciated that various configurations of the system can be implemented in any of a variety of combinations of components. Accordingly, the specific configuration of the system and its method of use described herein should be understood as not to be limited to any specific configuration or use, but instead can be implemented in any configuration and in any set of steps capable of excising tissue via a catheter system. Likewise, the various steps of the method described above with reference to Figs. 4A to 4K can all be included and / or somemay be omitted. And additional steps not described here are also possible. Steps can be done in different orders as well.

[0077] Systems and devices for burrowing into tissue comprise a catheter system such that it can be utilized w ithin minimally invasive procedures and / or traverse through the circulatory system to reach the site of procedure. The systems and devices can comprise a delivery catheter for delivery of a burrowing system to a tissue that is in connection with a controller system at the proximal end, which can be utilized to control the deliver}7catheter and the systems and devices for excision. In some implementations, deliver}7catheter systems and devices can further comprise a means for tissue ablation.

[0078] The systems and devices for burrowing into tissue can be utilized on any tissue, but especially on thickened tissue within the cardiovascular system. Any transcatheter approach can be utilized to reach the tissue to be excised, such as (for example) a transfemoral, subclavian, transapical, transjugular, or transaortic approach.

[0079] In some implementations, the system for excising tissue comprises a catheterbased burrowing system, which can be controlled by the proximal controller system. In some implementations, the burrowing system comprises a burrowing tip comprising two cooperative elongated tips that provide an incremental “dig-and-grasp” mechanism. The two elongated tips can each extend longitudinally along the proximal-distal axis, each of the two elongated tips tapering to a sharp point at the distal end. In some implementations, at least one of the two elongated tips comprise a set of one or more angled barbs configured to grasp tissue, which can hold and / or prevent reversal slippage the cooperative tips within the tissue. In some implementations, each barb of the set is angled back in the proximal direction. In some implementations, the set of barbs are provided along the proximal-distal axis. In some implementations, the two cooperative elongated are able to independently move and / or slide relative to one another an incremental distance along the proximal-distal axis.

[0080] The burrowing system can utilize a “dig-and-grasp” mechanism that incrementally digs into a tissue, using the barbs to grasp and hold the burrowing system in its place. In some implementations, the dig-and-grasp mechanism utilizes a spring, a taut line, and the tw o cooperative components. Of the tw o cooperative elongated tips, a first elongated tip can comprise the set of one or more angled barbs. The first elongated tip can further comprise a proximal face that is in contact with or otherwise operatively linked with the spring. The taut line can also be in connection with the first elongated tip. Of the two cooperative elongated tips, a second elongated tip can include a compartment for housing the spring operatively linked with the first elongated tip.

[0081] To distally advance the burrowing system, the second elongated tip can be distally advanced via an inner sheath that is in connection with the second elongated tip. As the second elongated tip is distally advanced, the first elongated tip being held in place by the taut line, causing the spring within the compartment to compress. To distally advance the first elongated tip, the taut line is loosened allowing the compressed spring to push the first elongated tip in the distal direction. For each incremental movement in the distal direction, the set of one or more barbs on the first elongated tip hold the burrowing system in place and / or prevent reversal movement of the burrowing system. The incremental distal advancement can be continued until the burrowing system reaches a desired location. In some implementations, once the burrowing system reaches a desired location, the system can be used as an anchor and a guide for another catheter system to reach the inner tissue location.

[0082] In some implementations, the burrowing system is utilized in combination with a tissue ablation catheter system, w hich can be controlled by the proximal controller system. The burrowing system can be utilized to urrow into a tissue to a desired location. The ablation catheter system can use the burrowing system as guide to ablate tissue along the path created by the burrowing system. Any ablation technique can be utilized, such as (for example) radiofrequency ablation (heat cauterization) or ciyoablation (freeze cauterization).

[0083] Provided in Figs. 5A to 5C is an example of a catheter system utilizing a burrowing system. The catheter system comprises a burro-wing system 501 in connection with an inner sheath 503, an outer sheath 505 capable of ensheathing the burrowing system, and a proximal controller system for controlling the burrowi ng system. Burrowi ng system 501 can comprise a first elongated tip 507 that is cooperative with a second elongated tip 509, each of which extending along the proximal-distal axis and tapering toward a sharp terminus 511 and 513 at the distal end. First elongated tip 507 can comprise a set of angled barbs 515 that are positioned on a face of the first elongated tip along the proximal-distal axis. Second elongated tip 509 can be slightly longer in length along the proximal-distal axis than first elongated tip 507. First elongated tip 507 and second elongated tip 509 are capable of independently sliding along the proximal-distal axis relative to one another.

[0084] Near the proximal end of second elongated tip 509 can comprise a compartment 517 just beyond the proximal end of first elongated tip 507. A spring 519 can be housed within compartment 517, the spring can be operatively linked with first elongated tip 507 to provide distally directed push force, such as being in contact with the proximal face 521 of the first elongated tip and an inner distal face 523 of the compartment. A taut line 525 is in connection with first elongated tip 507 and can extend proximally through the catheter system, passing through an aperture 527 within the distal end of second elongated tip 509.

[0085] Figs. 6A and 6B is an example of the relative movements of burrowing system 501 to yield a dig-and-grasp mechanism. Fig. 6A depicts burrowing system 501 in a rested state and Fig. 6B depicts the burrowing system in a compressed state. In the relaxed state, first elongated tip 507 and second elongated tip 509 are aligned such that distal terminus 511 and distal terminus 513 are at or near the same location along the proximal-distal axis. Spring 519 is in a relaxed, uncompressed state. As depicted in Fig. 6B, second elongated tip 509 can be distally advanced via the inner sheath, resulting in distal terminus 513 moving further distal than distal terminus 511 along the proximal-distal axis. First elongated tip 507 is held in place by taut line 525 and the set of barbs 515. Spring 519 is compressed within compartment 517 betw een the inner distal face 523 of the compartment and proximal face 521 of first elongated tip 507. Taut line 525 can be relaxed, allowing spring 519 to decompress to push first elongated tip 507 in the distal direction, such that the burrowing system 501 is back in the relaxed state as depicted in Fig. 6A. Burrowing system can 501 can repeat the transition between the relaxed state and compressed state to incrementally burrow' further into a tissue. The set of angled barbs 515 can provide a resistance force to promote distal advancement of second elongated tip 509 when transitioning to the compressed state. The set of angled barbs 515 can further prevent burrowing system 501 from retreating in the proximal direction.

[0086] While a specific configuration of a catheter-based burrowing system is described above with reference to Figs. 5 A to 6B, it should be readily appreciated that various configurations of the system can be implemented in any of a variety of combinations of components. Accordingly, the specific configuration of the sy stem described herein should be understood as not to be limited to any specific configuration, but instead can be implemented in any configuration capable of excising tissue via catheter system.

[0087] Provided in Figs. 7 A to 7F is an example of a method to use a catheter-based burrowing system in combination with an ablation system. In this example, the catheterbased burring system as depicted in Figs. 5A to 6B is utilized, but it is to be understood that various features or components of the system can be exchanged or altered for features or components capable of performing equivalent or similar tasks. Notably, although the depicted example shows the burrowing system used in combination with an ablation catheter system, the burrowing system can be utilized on its own or combined with any other catheter system in w'hich burrowing into tissue is desired.

[0088] Fig. 7A depicts a burrowing system 501 approaching a tissue 701 to be ablated. Burrowing system 501 can comprise a first elongated tip 507 and a second elongated tip 509 in connection with an inner sheath 503. Burrowing system 501 and inner sheath 503 isensheathed within an ablation catheter system 703, both of which are ensheathed within an outer sheath 505.

[0089] Fig. 7B depicts burrowing system 501 traversing into tissue 701, which can be achieved using the dig-and-grasp mechanism as depicted in Figs. 6A and 6B. Ablation catheter system 703 remains proximal to tissue 701 as burrowing system 501 traverses through the tissue.

[0090] Fig. 7C depicts burrowing system 501 traversing deeper into tissue 701 to a desired location within the tissue. At this point, burrowing system 501 can stop distally advancing and hold within the desired location as an anchor to provide a means of guidance for the ablation catheter system.

[0091] Fig. 7D depicts ablation catheter system 703 approaching tissue 701. Ablation catheter system 703 begins to ablate the tissue. Fig. 7E depicts further ablation by ablation catheter system 703, utilizing inner sheath 503 as a guide. Ablation catheter system 703 ablates tissue up until it reaches the distal end of burrowing system 501. Fig. 7F depicts the proximal retraction of ablation catheter system 703 and burrowing system 501, leaving a tract of ablated tissue.

[0092] While a specific configuration of a catheter-based burrowing and ablation systems are described above with reference to Figs. 7A to 7F, it should be readily appreciated that various configurations of the system can be implemented in any of a variety of combinations of components. Accordingly, the specific configuration of the system described herein should be understood as not to be limited to any specific configuration, but instead can be implemented in any configuration capable of excising tissue via catheter system. Likewise, the various steps of the method described above with reference to Figs. 7 A to 7F can all be included and / or some may be omitted. And additional steps not described here are also possible. Steps can be done in different orders as well.

[0093] In some implementations, the system and devices (e.t / ., for removing tissue) can comprise a dual function catheter system comprising a tissue mass excision system combined with a suturing system, each of which can be in connection with a controller system at the proximal end. A transcatheter delivery system can deliver the dual function catheter tissue excision and suturing system to a tissue site such that the tissue excision system excises a portion of native tissue and the suturing system can suture and repair the tissue where the excision occurred. In some implementations, the tissue excision system can comprise an excision tool having a compartment with a sharp edge, the compartment for housing and retrieving excised tissue. In some implementations, the suturing system cancomprise a needle assembly that comprises a plurality of needles and a suture for each needle.

[0094] In some implementations, the excision tool has a spoon-like design such that the distal end of the tool has a compartment in connection with a rod extending proximally. In some implementations, the compartment comprises or is operatively linked with a sharp edge configured to cut tissue. In some implementations, the bowl comprises a one or more walls that form a compartment, the one or more walls comprising a partially closed and partially open face for capturing excised tissue as it is cut by the sharp edge. In some implementations, the partially open face is configured to close to transform into a closed compartment to secure excised tissue therein.

[0095] In some implementations, the compartment is in connection with a rod, the rod capable of rotating the compartment and the sharp edge in a circular direction. The sharp edge is configured to cut through and excise a mass of tissue as the compartment is rotated in a circular motion. In some implementations, as the sharp edge is excising the mass of tissue, the compartment with an open face is configured to capture the excised tissue mass. In some implementations, the rod is further capable of advancing and retracting the compartment along the proximal-distal axis such that upon excision and capture of a tissue mass, the rod can proximally retract the compartment. In some implementations, proximal retraction of the compartment provides the suture system space to repair the remaining tissue after excision.

[0096] In some implementations, the needle assembly of the suture system can include a needle holder that can hold each of the needles to help the needles penetrate and traverse a tissue. In some implementations, the needle holder allows the needles to act in unison such that all the needles penetrate and traverse the tissue at the same time.

[0097] In some implementations, a driver system can be utilized to drive the needles to penetrate and traverse the tissue, which can be controlled by the proximal controller system. In some implementations, the driver system utilizes a torqueing mechanism. Accordingly, the driver system can be turned in a circular direction to drive needles in a circular motion such that needles penetrate and traverse the tissue. As the needles traverse the tissue, each needle carries along a suture that is left within the tissue.

[0098] The systems and devices can further comprise a final suture that can be utilized to gather and tighten all the sutures traversing the injury and / or opening, resulting in a closing of the injury and / or opening.

[0099] Figs. 8A and 8B provide an example of a dual system for excising and repairing tissue within the cardiovascular system and / or other tissue. In some implementations, thesystem comprises a suturing system 801, an excision tool 802, a suturing driver 803 within a catheter 805, and a proximal controller system for controlling the suturing system, excision tool, and suturing driver.

[0100] In some implementations, the catheter 805 can comprise an elongated aperture 807 towards the distal end that spans along the distal-proximal axis. Elongated aperture 807 is large enough to allow exposure of suturing system 801 and the distal end of excision tool 802. Catheter 805 can further comprise a closed distal tip 809. Proximal to the suturing system 801 is driver 803, which can be fully encapsulated within a catheter sheath.

[0101] In some implementations, the distal end of excision tool 802 can comprise a compartment 804, which can retain excised tissue therein. Compartment 804 can comprise a sharp edge 806 for cutting tissue. A rod 808 can be in connection with compartment 804 such that it can rotate the compartment to perform the excision.

[0102] In some implementations, the suturing system can comprise a plurality of needles 811 attached to a needle holder 813, a plurality of traversing sutures 815 for traversing the injury, rupture, incision, and / or opening, and a final suture 817 for tightening traversing sutures 815 to close the injury, incision, and / or opening. Suturing driver 803 can comprise a torqueing rod 818 for driving needle holder 813 and needles 811 such that they penetrate and traverse the injured tissue. Suturing driver 803 can further comprise a suture positioning shaft 819 for position the plurality of traversing sutures. Compartment 804 can be configured to fit within and adjacent to the plurality of needles 811 to yield a compact dual system catheter.

[0103] Provided in Figs. 9A and 9B are detailed views of suturing driver 803. Suturing driver 803 comprises a rounded torqueing rod 818 that is capable of turning in a circular motion. The proximal end of needle holder 813 is attached or otherwise fixed to the outer edge of torqueing rod 818 such that when torqueing rod is turned in a circular motion, the needle holder turns in the circular motion as well. Needle holder 813 contains a groove along its axis that extends distally to suturing system 801. Groove allows suture positioning shaft 819 to situate therein, which also extends distally to suturing system 801. Within torqueing rod 818 is a channel 821 that allows for suture positioning shaft limited circular motion. Torqueing rod 818 can further comprise a hollowed portion 816 that can fit compartment 804 therein.

[0104] Provided in Figs. 10A to 10D are detailed views of the distal end of catheter 805, the distal end of excision tool 802, and suturing system 801. Catheter 805 contains a flex hinge 820 that allows the catheter to flex and bend such that elongated aperture 807 and suturing system 801 can position and sit atop a wound, injury, incision, opening, etc. to beclosed and / or repaired. Within the catheter 805 are a number of grooves and notches that allow openings and pathways for sutures to fit w ithin and / or travel therethrough. As can be viewed within elongated aperture 807 are suture loop notches 823 that allow suture loops 825 to fit therein.

[0105] In some implementations, a final suture channel 827 within the sidewall of catheter 805 and extends along the axis of the catheter. Final suture channel 827 further extends to and curves completely around and within closed distal tip 809. Suture loop notches 823 traverse final suture channel 827 such that when suture loops 825 are within the notches, final suture 817 can travel through the final suture channel and through each of the suture loops.

[0106] As will be discussed in more detail later, passing final suture 817 through each of suture loops 825 provides a means gathering and tightening traversing sutures 815 to close the remaining tissue after excision.

[0107] In some implementations, excision tool 802 comprises a compartment 804 with a rounded back 810 and a face opposite of the rounded back that contains a portion that is closed 812 and a portion that is open 814 to yield an entry way into the compartment. At least a portion of edge 806 can be sharp to cut through tissue. Excision tool can further comprise a rod 808 that extends distally. Rotating rod 808 in a circular motion rotates compartment 804 such that edge 806 can traverse through tissue, which can be captured in the compartment. The portion 812 of the face opposite to the rounded end that is closed can help hold excised within compartment 804. In some implementations, the portion 814 of the face opposite to the rounded end that is open can be closed after capturing tissue in the compartment using (for example) a slidable plate that can be stored under closed portion 812 and can be slide across and over the open portion.

[0108] In some implementations, suturing system has four needles 811 and each needle contains a traversing suture 815 within the needle’s inner lumen 829. Each needle further has a tip 831 for penetrating and traversing though tissue, which can be beveled or otherwise have a sharp edge. Across the opening of needle inner lumen 829 from needle tip 831 is a suture loop slit 833, that allows suture loops 825b open up and fit therein as part of the suturing mechanism, as described in greater detail below.

[0109] At the opposite side from needle tip 831, needles 811 are fixed to the distal portion of driving needle holder 813, which extends proximally to the torqueing rod 818. Where needles 811 are fixed to driving needle holder 813 is a suture positioning channel 835 within each needle. Suture positioning channel 835 allows for limited circular movement of suture positioning shaft 819 therein. Suture positioning shaft 819 traverses suture loops 825b onone side of the catheter. Suture positioning channel 835 allows movement of suture positioning shaft 819 to open up and to position suture loops 825b within suture loop notches 823, the mechanism to be described in more detail below .

[0110] While a specific configuration of a catheter-based excision and repair system is described above with reference to Figs. 8A to 10D, it should be readily appreciated that various configurations of the system can be implemented in any of a variety of combinations of components. Accordingly, the specific configuration of the system described herein should be understood as not to be limited to any specific configuration, but instead can be implemented in any configuration capable of excising tissue via catheter system.

[0111] Systems and devices for excising and repairing tissue can be delivered to the site of tissue via catheter. In some implementations, the catheter delivery system can be traversed through the circulatory system to a site within cardiovascular system in which tissue is to be excised, including the heart and arteries. Any transcatheter approach can be utilized to reach the site of tissue excision, such as (for example) a transfemoral, subclavian, transapical, transjugular, or transaortic approach. In some implementations, the site of tissue excision is tissue that is thickened in which at least a portion of the thickened tissue is excised according to the steps below-.

[0112] Provided in Figs. 11A1 to 11K is an example method of utilizing a dual function catheter system for excising and repairing tissue. A delivery catheter can deliver the excision and repair systems to the general area of the tissue to be excised. At that point, catheter 805, excision tool 802, and suturing system 801 is advanced to the site of tissue excision, as shown in Figs. 11A1 and 11A2.

[0113] In some implementations, elongated aperture 807 can then be positioned onto the tissue 1101 to be excised such that catheter distal tip 809 is located near one end of the excision site and flex hinge 820 is located near the other end of the excision site. Excision tool 802 and suturing system 801 are delivered in an initial state. Accordingly, excision tool 802 is resting above tissue 1101 with edge 806 of the tool in contact with or near the tissue.

[0114] To excise tissue, excision tool 802 is rotated approximately 180° via rod 808, w-hich results in excision and capture of tissue mass 1101, w-hich is captured within compartment 804, as seen in Fig. 11B. The distal end of excision tool 802 can be proximally retracted into a hollow-ed portion 816 of torqueing rod 818, as shown in Fig. 11C. With the tissue mass excised and excision tool 802 moved out of the w-ay, suturing system 801 can now perform the repair. Accordingly, needles 811 are resting above remaining tissue 1103 with edge 806 of the tool and needle tip 831 in contact with or near the tissue with traversing sutures 815 within the needle’s inner lumen 829, as shown in Fig. 11D.

[0115] Upon turning torqueing rod 818 of suturing driver 803 in a circular direction, suturing system 801 is actuated. Figs. 11E1 and 11E2 show the result of turning torqueing rod 818 and actuating the suturing system. Because needles 811 are in connection with torqueing rod 818 via the driving needle holder 813, the needles also move in a circular direction to penetrate the tissue surface and traverse remaining tissue 1103 and the associated tissue. Needle tip 831 traverses all the w ay through the remaining tissue and exits the tissue surface on the other side while the body of needles remain within the remaining tissue. The movement of needles 811 carries the traversing sutures 815 within inner lumen 829 through the injury' and / or opening and the tissue.

[0116] With needles 811 traversed and resting within remaining tissue 1103 and the surrounding tissue, suture loops 825a are actuated by suture positioning shaft 819 to open up and out of inner lumen 829 and slide into and fit within suture loop notches 823a (Fig. 11F). To actuate suture loops 825a, suture positioning shaft 819 is moved in a circular direction within suture positioning channel 835. Because suture positioning shaft 819 is within suture loops 825b, the movement of suture positioning shaft 819 pushes sutures 815 through inner lumen 829, pushing out suture loops 825a. Once out of the aperture, suture loops 825a open outward and fit within suture loop notches 823a such that the inner circumference of suture loops 825a are in line with final suture channel 827. With suture loops 825a open and in position, final suture 817 is advanced distally 1105 through final suture channel 827 and each of suture loops 825a to the other side of the loops, near or within distal tip 809 (Fig. 11G). Further, suture positioning shaft 819 is retrieved proximally and removed out of catheter 805.

[0117] With suture positioning shaft 819 removed and final suture 817 traversed through suture loops 825a, torqueing rod 818 can turn back in a circular direction to turnback needles 811 via the needle holder 813 such that the needles reversing back through the tissue and injury and / or opening until positioned above the injury and / or opening. As needles 811 rev erse back, final suture 817 holds suture loops 825a and prevents traversing sutures 815 from reversing back and thus traversing sutures remain traversed through the injury and / or opening and surrounding tissue (Figs 11H1 and 11H2). Furthermore, as the needles 811 turn back, suture loop slit 833 grasps suture loops 825b such that the suture loops open outward and fit within suture loop notches 823b and the inner circumference of suture loops 825a are in line with final suture channel 827. With suture loops 825b open and in position, final suture 817 is advanced 1109 across and around final suture channel 827 within catheter distal tip 809 and then further advanced proximally on the other side of the catheter through each of suture loops 825b (Fig. ill).

[0118] Upon final suture 817 traversing through suture loops 825b, catheter 805 can be removed off of the remaining tissue 1103 and returned proximally such that only traversing sutures 815 and the final suture remain (Fig. 11J). Accordingly, traversing sutures 815 traverse through the remaining tissue with suture loops 825a and 825b just above the tissue surface on opposite sides of the remaining tissue. Final suture rests within suture loops 825a and 825b and provides a means for cinching traversing sutures 815 such that they can come together and close the opening. As shown in Fig. 11J, a pledget 837 is positioned onto final suture 817 and advanced distally to cinch traversing sutures 815. The cinching mechanism results in closing of the opening within remaining tissue 1103 (Fig. 11K). It should be understood that any mechanism for cinching the traversing sutures 815 via final suture 817. Final suture can be tied off or otherwise secured.

[0119] While a specific configuration of a dual function catheter excision system and suturing system is described above with reference to Figs. 11A to 11K, it should be readily appreciated that various configurations of the system can be implemented in any of a variety of combinations of components. Accordingly, the specific configuration of the system described herein should be understood as not to be limited to any specific configuration, but instead can be implemented in any configuration capable of excising tissue via catheter system. Likew ise, the various steps of the method described above with reference to Figs. 11A to 11K can all be included and / or some may be omitted. And additional steps not described here are also possible. Steps can be done in different orders as well.

[0120] Systems and devices for flattening an area of thickened tissue comprise a mechanical system for attachment to and stretching tissue. The systems and devices can be installed surgically or be delivered via a catheter system. The systems and devices can comprise a plurality of anchored struts that can utilize a mechanical means to stretch tissue.

[0121] In some implementations, the mechanical system for stretching tissue can comprise a set of two struts connected via a hinge. The system can further comprise a component to lock the hinge in a straightened position such that the two struts are maintained in a straight elongated conformation. Anchors can be provided at the peripheral end of each of the two struts. In some implementations, to stretch and flatten tissue, the system can be positioned with the hinge over an area of tissue to be stretched (e.g., a bulge of thickened tissue). The system can be anchored to the tissue at the two ends of each strut with the hinge bent at an angle less than 180°. The hinge can be flattened to at or about 180° such that the two anchors are forced to move in opposite directions, which results in stretching and flattening of the thickened tissue. A component can lock the hinge in the straightened position. Any component for locking a hinge in straightened position can be utilized, such as (for example) a pin, a cap, or a sleeve.

[0122] In some implementations, the mechanical system for stretching tissue is a plurality of struts that form one or more crossbars with a pivot at strut intersections. The system can comprise a means to stretch the area of the crossbar in at least one direction. Anchors can be provided at the ends of each crossing strut, forming a quadrilateral among the set of anchors. In some implementations, the means to stretch the area is one or more additional outer struts that extend along at least one side of the perimeter of the quadrilateral between two ends of the crossing struts; the one or more additional struts capable of elongating and / or shortening along at least one axis. When the one or more perimeter struts is elongated and / or shortened, the quadrilateral formed by the set of anchors elongates in one dimension and shorten in the other dimension. In some implementations, to flatten tissue, the system can be positioned with the one or more crossing struts positioned over thickened tissue. The system can be anchored to the tissue at each end of each crossing struts, forming an initial quadrilateral among the anchors. A perimeter strut can be elongated and or shortened to elongate the quadrilateral in one dimension, which results in stretching and flattening of the thickened tissue. Any means for elongating or shortening a perimeter strut can be utilized, such as (for example) a set gear of gears, a rack and pinion, a ratchet, slidable members, etc.

[0123] The systems and devices for flattening tissue can be utilized on any thickened tissue of the cardiovascular system, including tissue of the heart and circulatory’ system. If catheter delivery is performed, any transcatheter approach can be utilized to reach the thickened tissue to be flattened. Alternatively, a surgical approach can be utilized to deliver the systems and devices.

[0124] Provided in Figs. 12A and 12B is an example of a mechanical system for flattening thickened tissue. The system comprises a first strut 1201, second strut 1203, and a hinge 1205 between the first and second strut. A first anchor 1207 is provided at the peripheral end of first strut 1201 and a second anchor 1209 is provided at the peripheral end of second strut 1203. The anchors can be any tool for anchoring a strut to a tissue, such as (for example) a helical screw. Distance Di between anchor 1207 and anchor 1209 when hinge 1205 is bent at an angle less than 180° is less than distance D2between anchor 1207 and anchor 1209 when hinge 1205 is straightened (e.g., to at or about 180°). In the example depicted in Figs. 12A and 12B, a sleeve member 1211 is provided that can slide over hinge 1205 when straightened to at or about 180°, locking the hinge in that conformation.

[0125] Provided in Figs. 13A and 13B is an example of installing a mechanical system to flatten a thickened tissue. In this example of installation, the example of the mechanical system shown and described in reference to Figs. 12A and 12B is utilized. To flatten tissue, hinge 1205 is positioned over thickened tissue 1301. Anchor 1207 and anchor 1209 areinstalled on opposite sides of thickened tissue 1301 w ith hinge 1205 at an angle less than 180°. Strut 1201 and strut 1203 are pushed towards thickened tissue such that hinge 1205 is straightened, resulting in flattening of thickened tissue 1301. Sleeve member 1211 is slid to cover hinge 1205, locking the hinge in its straightened conformation.

[0126] Provided in Figs. 14A and 14B is an example of a mechanical system for flattening thickened tissue. The system comprises a first strut 1401 and a second strut 1403 that crossover one another w ith pivot point 1405 at the intersection of the two struts. The system comprises a third strut 1407 and a fourth strut 1409 that crossover one another with pivot point 1411 at the intersection of the two struts. Six anchors 1413 are provided, each anchor at one end of each strut. The anchors can be any tool for anchoring a strut to a tissue, such as (for example) a helical screw. Two of the six anchors 1413a and 1413b are shared between two struts. The unshared anchors 1413c, 1413d, 1413c, and I4i3f form a quadrilateral among them. Strut 1415 and strut 1417 are joined by a means of elongation 1419 and connect anchors 1413b and 1413c. Strut 1421 and strut 1423 are joined by a means of elongation 1425 and connect anchors 1413b and I4i3f. The means for elongation 1419 and means of elongation 1425 can be (for example) a set of gears, a rack and pinion, a ratchet, or slidable members. As depicted in Fig. 14A, strut 1415 and strut 1417, and strut 1421 and strut 1423 are in an elongated conformation, having a distance D3for one dimension of the quadrilateral. As depicted in Fig. 14B, strut 1415 and strut 1417, and strut 1421 and strut 1423 are in a shortened conformation, having a distance D4for one dimension of the quadrilateral, where D4is greater than D3. Accordingly, means for elongation 1419 and means for elongation 1425 can elongate and / or shorten the dimensions of the quadrilateral formed by anchors 1413c, 1413d, 1413c, and 1413E

[0127] To flatten tissue, the mechanical system depicted in Figs. 14A and 14B can be installed over thickened tissue. By elongating and and / or shorten the dimensions of the quadrilateral, the thickened tissue can be stretched in one dimension, resulting in flattening of the tissue.

[0128] While a specific configurations of mechanical systems for flattening tissue are described above with reference to Figs. i2Ato 14B, it should be readily appreciated that various configurations of the system can be implemented in any of a variety of combinations of components. Accordingly, the specific configuration of the system described herein should be understood as not to be limited to any specific configuration, but instead can be implemented in any configuration capable of installing an implant via a delivery catheter.

[0129] A system and devices for coring into tissue comprise a catheter system such that it can be utilized within minimally invasive procedures and / or traverse through the circulatory system to reach the site of procedure. The system and devices can comprise a deliverycatheter for delivery’ of a coring system to a tissue to be cored. The system and devices can be in connection w ith a controller system at the proximal end, which can be utilized to control the delivery’ catheter and the coring system. In some implementations, the system and devices can further comprise a means for tissue ablation.

[0130] The system and devices for coring tissue can be utilized on any tissue, but especially on thickened tissue within the cardiovascular system. Any transcatheter approach can be utilized to reach the tissue to be excised, such as (for example) a transfemoral, subclavian, transapical, transjugular, or transaortic approach.

[0131] In some implementations, the coring system comprises a blade system and a grasper. The blade system can comprise perimeter blade system and a traversing blade system. The coring system can be generally configured to core and remove a tract of tissue (e.g., to excise a cylindrical tract of tissue).

[0132] The grasper can be a helical coil, a barbed spear (e.g., harpoon-like spear), a hook, a screw, or any other tool that can pierce into and grasp tissue. The grasper can extend longitudinally along the proximal-distal axis with a piercing tip at the distal end. To perform coring of tissue, the grasper can be inserted andor rotated such that the piercing tip pierces and traverses through the tract of tissue to be cored. Once the tract of tissue is cored by the perimeter blade system and traversing blade system (as discussed in detail further below), the tissue tract can be excised by proximally retracting the grasper. In some implementations, the grasper can be in connection with the controller system via a torqueing connector that extends proximally from the helical coil through the catheter system to controller system. The torqueing connector can be a wire, a tube, an inner sheath, or any other connector that enables advancement (and optionally also rotation) of the grasper via the controller system. The grasper can comprise a hard-stop component at its proximal end, such as a disc, a plate, a flange, or some other physical component, which can act as a hard stop for controlling the depth the grasper inserts into tissue. The proximal disc, plate, flange, or other component can further be shaped and / or comprise notches or through-holes to allow for distal advancement and proximal retraction of the blade system.

[0133] The blade system can comprise a perimeter blade system configured to cut an outer perimeter of a tract of tissue. The perimeter blade system can comprise one or more perimeter blades, each perimeter blade comprising a sharp edge that extends longitudinally in the general direction of the proximal-distal axis such that it can cut an outer perimeter of a tract of tissue when rotated. The perimeter blade system can optionally further comprise a sharp edge at the distal edge of the perimeter blade to pierce and incise in the tissue in distal direction (e.g., deeper into the tissue). The longitudinal blade edge can be the same sharp edge as the distal blade edge (e.g., an angled edge like a scalpel) or two edges (e.g., twoorthogonal edges). The perimeter blade system can be in connection w ith the controller system via a torqueing connector that extends proximally from the one or more perimeter blades through the catheter system to controller system. By rotating the torqueing connector, the longitudinal sharp edge to move along a perimeter (e.g., along the perimeter of an ellipse) such that an outer face a cored tract of tissue is yielded (e.g., the outer face of a cylindrical core of tissue). The torqueing connector for the perimeter blade system can be the same or a different torqueing connector than the one configured to rotate the grasper.

[0134] The blade system can comprise a traversing blade system configured to cut the distal face of the tract of tissue, resulting in release in the tract of tissue. The traversing blade system can comprise one or more traversing blades, each traversing blade constructed with a shape-memory material and preloaded memory-fixed to bend orthogonally inward from the outer perimeter and across the distal end of the tract of tissue to be cored. Each traversing blade can be kept with in a compartment that is housed within or nearby a perimeter blade. The compartment can keep the blade in the same plane as the perimeter blade when within the catheter and prior to performing the traversal cut. Each traversing blade can be in connection with a connector that allow s the controller system to distally advance the traversing blade out of the compartment. As the traversing blade is distally advanced and emerges out of the compartment, the preloaded memory-fixed force bends the blade in orthogonal inw ard direction, resulting in the blade traversing across the distal end of the tract of tissue. Any shape-memory material can be utilized, such as (for example) nitinol. The traversing blade system can be in connection with the controller system via a torqueing connector that extends proximally from the one or more traversal blades through the catheter system to controller system. By rotating the torqueing connector, the one or more traversing blades slice the tract of tissue at the distal end, resulting in the release of the cored tract of tissue. The torqueing connector for the traversing blade system can be the same or a different torqueing connector than the one configured to rotate the perimeter blade system.

[0135] In some implementations, the system for excising tissue further comprises a sheath. The sheath is configured to ensheathe the grasper, the perimeter blade system, and / or the traversing blade system . The sheath is capable of proximally retracting and distally advancing. The sheath can be configured such that the helical coil, the perimeter blade system, and / or the traversing blade system can distally advance out of the sheath and / or proximally retreat back into the sheath.

[0136] Provided in Figs. 15A and 15B is an example implementation of a catheter-based tissue coring system. As described in this example, the catheter-based coring system comprises a perimeter blade system 1516, a traversing blade system 1517, and a helical coil 1507. The catheter-based coring system may further comprise a controller at the proximalend of the catheter system and is in connection with to the distal end of the catheter-based coring system. The catheter-based coring system can be generally configured to core and remove a tract of tissue. In this depicted example, a helical coil 1507 is utilized to grasp tissue, but a barbed spear, a set of hooks, or another grasping tool can be utilized instead. The helical coil 1507 comprises a distal end and a proximal end. The distal end of the helical coil 1507 can comprise a blade tip 1512, which can be utilized as a leading sharp point to pierce and traverse through tissue at the site of ablation. The coring system can further comprise a disc 1502 at the proximal end of the helical coil, w hich can be utilized as a hard stop to control depth insertion of the helical coil. The disc 1502 is a substantially flat element with a proximal face and a distal face. The proximal end of the helical coil 1507 can be in connection with and / or directly attached to the distal face of the disc 1502. The proximal face of the disc 1502 can be in connection with and / or directly attached to a torqueing connector 1501. The torqueing connector 1501 can be configured to distally advance, proximally retract, and / or rotate the disc 1502 via connection with the controller.

[0137] The perimeter blade system comprises a pair of perimeter blades (1508A and 1508B) flanking the disc 1502, each with a perimeter-blade torqueing connector 1509A and 1509B that extends proximally and is connection with the proximal controlling system. Each perimeter blade 1508A and 1508B further comprises a leading blade edge 1513A and 1513B and a trailing blunt edge 1514A and 1514B. Each perimeter blade 1508A and 1508B further comprises a hollowed-out compartment configured to house a traversing blade, which can be an internal hollowed-out space.

[0138] The traversing blade system can comprise a push-wire connector 1511A and 1511B and a traversing blade 1510A and 1510B further comprising a blade edge 1516A and 1516B. Each traversing blade is configured to extend distally and out of an aperture of the hollowed- out compartment of the perimeter blade, . In some implementations, the traversing blade is a spade shape with a pointed leading edge. In some implementations, the traversing blade is a triangular shape with a pointed leading edge. In some implementations, the traversing blade is a circular shape with a rounded sharp leading edge. As the leading edge of the traversing blade extends out of the aperture, it is configured to extend orthogonally from the rotational plane of the perimeter blade system and tow ards (and beyond) an axis centered within the perimeter blade system. A portion of each torqueing connector is distally extended beyond the aperture. As each traversing blade is distally advanced beyond the aperture, it exerts an inw ard bend force to orthogonally extend the traversing blade.

[0139] The perimeter-blade torqueing connectors 1509A and 1509B and the push-wire connectors 1511A and 1511B extend proximally to the proximal controller, which can beutilized to control the distal advancement, proximal retraction, and / or rotation of the coring perimeter blade system 1516 and the paddle traversing blade system 1517, respectively.

[0140] The coring system further comprises a sheath 1505. The sheath further comprises w ire through-holes configured that allow passage of the torqueing and push-wire connectors. For example, the sheath may comprise through-holes 1506A and 1506B configured to align w ith the perimeter-blade torqueing connector 1509A, 1509B and push-wire connectors 1511A, 1511B. The sheath may comprise through-hole 1506C configured to align with torqueing connector 1501, respectively. The sheath is configured to sheathe and unsheathe the disc, the helical coil, perimeter blade system, and traversing blade system as the individual components are distally advanced and proximally retracted.

[0141] Provided in Figs. 16A to 16E is an example of an implementation of a method for excising tissue using a catheter-based coring device. In this example, the catheter-based coring system as depicted in Figs. 15A and 15B is utilized, but it is to be understood that various features or components of the system can be exchanged or altered for features or components capable of performing equivalent or similar tasks. For example, although the coring system utilizes two perimeter blades and two traversing blades, more or any number of perimeter blades and traversing blades can be utilized to perform the excision. Or alternatively, the helical coil can be replaced with another grasping tool, such as a barbed spear or hook. In addition, various features or components of the system can be exchanged or altered for features or components to perform alternative tasks within the provision of tissue excision, as would be understood in the art.

[0142] Fig. 16A depicts the catheter-based coring system reaching tissue 1601 to be excised. The distal end of the helical coil 1507 is orientated towards the surface of the target tissue 1601 such that the blade tip 1512 of the helical coil 1507 is in contact with the surface of the target tissue 1601. The proximal end of the helical coil 1507 is attached to the distal face of the disc 1502. The central axis of the helical coil 1507 may be aligned with the center of the disc 1502 along the proximal-distal axis. The torqueing connector 1501 is attached to the proximal face of the disc 1502 at the disc connector 1503. The disc connector may be centered on the proximal face of the disc 1502, such that it aligns with the center of the helical coil 1507. The perimeter blade system and traversing blade system are housed within the sheath 1505 while the coring system is navigated to the site of the target tissue 1601. The perimeter blade system and the traversing blade system may be provided within a sheath, such as the sheath. When reaching the site of excision, the perimeter blade system and traversing blade system may be unsheathed at the site of excision by being distally advanced into the target tissue.

[0143] Fig- 16B depicts the helical coil 1507 of the catheter-based coring system traversing the target tissue 1601. The torqueing connector 1501 is rotated in the direction of rotation 1518 such that the blade tip 1512 of the helical coil 1507 pierces into the target tissue 1601. The coring system is rotated such that helical coil 1507 traverses through tissue until the distal face of the disc 1502 is at or near the surface of the target tissue 1601, which can provide a hard stop. Upon traversal into the tissue, the helical coil 1507 grasps the tissue to be excised 1602. The helical coil 1507 may have a smaller radius of the disc 1502.

[0144] Fig. 16C depicts the perimeter blade system traversing through tissue 1601. Each perimeter blade (1508A and 1508B), with an ensheathed traversing blade, traverses the tissue through the blade notches 1504A and 1504B on the edge of the disc 1502. As each perimeter blade (1508A and 1508B) traverses the tissue 1601, blade notches 1504 can help position and / or allow passage of the perimeter blades movement such that the perimeter blades traverse the tissue 1601 adjacent to the periphery of the helical coil 1507. The perimeter-blade torqueing connectors 1509A and 1509B may be used to proximally advance, distally retract, and rotate the perimeter blades 1508A and 1508B.

[0145] Fig. 16D depicts the slicing of the tissue 1602. Each traversing blade (1510A and 1510B) is distally extended out of the traversing blade compartment by the push-wire connectors 1511A and 1511B. The traversing blade is configured to extend distally out of the aperture of the hollowed-out compartment of the perimeter blade. As each traversing blade 1510A and 1510B is distally advanced, a portion of the torqueing connector 1511A and 1511B adjacent to the traversing blade 1510 is configured to bend at a shape set bend point 1515B such that the traversing blade extends orthogonally to the plane of rotation of the perimeter blade. As the leading edge of the traversing blade extends out of the aperture, it is configured to extend orthogonally from the rotational plane of the perimeter blade system and towards an axis centered within the perimeter blade system.. The traversing blades 1510A and 1510B and push-wire connectors 1511A and 1511B may be composed of a shape memory material (e.g., nitinol) having a memory to yield an inward bend force.

[0146] The perimeter blades 1508A and 1508B and traversing blades 1510A and 1510B are rotated about the helical coil 1507. The perimeter blade 1508A and 1508B and the traversing blade 1510 are rotated by rotating the perimeter-blade torqueing connectors 1509A and 1509B . The rotation can be performed such that the leading blade edges (1513A and 1513B) slice tissue 1602 adjacent to the periphery7of the helical coil 1507 and the edges of traversing blades (1510A and 1510B) slice through the tissue at the distal end of the helical coil. Rotation of the set of perimeter blades (1508A and 1508B) and traversing blades (1510A and 1510B) may be alternatively and / or additionally aided by the rotation of the torqueingconnector 1501, utilizing blade notches 1504A and 1504B to push the perimeter blades 1508A and 1508B.

[0147] Fig. 16E depicts the removal of the tissue 1601. The target tissue 1602 is grasped by the helical coil 1507. The distal end of the target tissue 1602 is optionally further supported by the traversing blade 1510. The target tissue 1602 is optionally further supported on the sides by the perimeter blade 1508. With the tissue 1601 grasped, the perimeter blade and traversing blade systems are proximally retracted into the sheath 1505, which is then further proximally retracted via the transcatheter system and removed from the recipient.

[0148] While specific configurations of a catheter-based excision and coring system are described above with reference to Figs. 15A to 16E, it should be readily appreciated that various configurations of the system can be implemented in any of a variety of combinations of components. Accordingly, the specific configuration of the system described herein should be understood as not to be limited to any specific configuration, but instead can be implemented in any configuration capable excising tissue via catheter system.EXAMPLES

[0149] Example 1. A transcatheter system for excising tissue, comprising: an outer sheath having a proximal-distal axis; and a blade system ensheathed within the outer sheath, the blade system comprising a set of two or more blades, each blade laterally curved and overlapping another blade on each lateral side such that the set of blades form a tubular shape; the blade system further comprising an inner sandwich sheath ensheathed within the set of blades; wherein the blade system is capable of moving independently of the outer sheath along the proximal -distal axis; and wherein the set of blades, the inner sandwich sheath, are each capable of moving independently along the proximal-distal axis.

[0150] Example 2. The system of example 1, wherein each blade has a tapered edge to form a vertex at a distal end.

[0151] Example 3. The system of example 2, wherein each distal tip of each blade is configured to collapse inward, the set of blades forming a conical shape when collapsed.

[0152] Example 4. The system of example 2 or 3, wherein each blade is composed of a shape memory material, the shape memory material having a memory to yield an inward collapse force.

[0153] Example 5. The system of example 4, wherein the inner sandwich sheath is capable of being positioned to prevent the inward collapse force.

[0154] Example 6. The system of any one of examples 1-5 further comprising a suture system that comprises: a helical coil that extends along the proximal-distal axis, wherein the helical coil comprises a hollowed inner lumen; an anchor positioned at a distal end of the helical coil; and a suture attached to the anchor and extended through the inner lumen of the helical coil.

[0155] Example 7. The system of example 6, wherein the suture system and the blade system are each capable of moving independently along the proximal -distal axis relative to one another.

[0156] Example 8. The system of example 7, wherein the suture system can be rotated while being distally advanced or proximally retracted.

[0157] Example 9. The system of example 6, 7, or 8, wherein the anchor has a sharp distal tip and barbs.

[0158] Example to. The system of any one of examples 6-9, wherein the suture system further comprises a pusher that extends through the inner lumen of the helical coil.

[0159] Example 11. A method for excising tissue, comprising: delivering a transcatheter system to a site of cardiovascular tissue to be excised within a recipient, the transcatheter system comprising: an outer sheath having a proximal-distal axis; and a blade system ensheathed within the outer sheath, the blade system comprising a set of two or more blades, each blade laterally curved and overlapping another blade on each lateral side such that the set of blades form a tubular shape; the blade system further comprising an inner sandwich sheath ensheathed within the set of blades; wherein the blade system is capable of moving independently of the outer sheath along the proximal-distal axis; and wherein the set of blades, the inner sandwich sheath, are each capable of moving independently along the proximal-distal axis; distally advancing the set of blades with the inner sandwich sheath into the tissue yielding a tract of tissue within a lumen of the set of blades; proximally retracting the inner sandwich sheath, allowing a distal tip of each blade to collapse inward such that the distal tip of each blade comes together upon collapsing, encapsulating the tract of tissue therein; and proximally retracting the blade system such that the tract of tissue is excised.

[0160] Example 12. The method of example 11, wherein each blade has a tapered edge to form a vertex at a distal end.

[0161] Example 13. The method of example 11 or 12, wherein each blade is composed of a shape memory material, the shape memory material having a memory to yield an inward collapse force.

[0162] Example 14. The method of example 11, 12, or 13, wherein the step of distally advancing the set of blades further comprises rotating the blades in a circular direction.

[0163] Example 15. The method of any one of examples 11-14, wherein the step of proximally retracting the inner sandwich sheath further comprises rotating the blades in a circular direction.

[0164] Example 16. The method of any one of examples 11-15, wherein the system further comprises a suture system that comprises: a helical coil that extends along the proximal- distal axis, wherein the helical coil comprises a hollowed inner lumen; an anchor positioned at a distal end of the helical coil; and a suture attached to the anchor and extended through the inner lumen of the helical coil; the method further comprising: distally advancing the suture system through peri-tract tissue; releasing the anchor within the peri-tract tissue; proximally retracting the suture system back out of the peri-tract tissue such that the anchor and suture remain within the peri-tract tissue; tightening the suture to gather the peri-tract tissue; and securing the suture to the peri-tract tissue.

[0165] Example 17. The method of example 16, wherein the step distally advancing the suture system through peri-tract tissue comprises turning the helical coil in a circular direction.

[0166] Example 18. The method of example 16 or 17, wherein the step distally advancing the suture system through peri-tract tissue is performed prior to the step of proximally retracting the blade system.

[0167] Example 19. The method of example 16, 17, or 18, wherein the step of proximally retracting the suture system back out of the peri-tract tissue comprises turning the helical coil in a circular direction.

[0168] Example 20. The method of any one of examples 11 to 19, wherein the transcatheter system reaches the site of tissue to be excised within the cardiovascular system via a transfemoral approach, a subclavian approach, a transapical approach, or a transaortic approach.

[0169] Example 21. A transcatheter system for burrowing into a tissue, comprising: an outer sheath having a proximal-distal axis; an inner sheath ensheathed within the outer sheath; and a system for burrowing in connection with a distal end of the inner sheath, the system for burrowing comprising two cooperative elongated tips, w herein the two cooperative elongated tips comprise a first elongated tip and a second elongated tip, each tip tapering to a point at the distal end; wherein the first elongated tip comprises a set of barbs, each barb angled back in the proximal direction; wherein the first elongated tip and thesecond elongated tip are able to independently move relative to one another along the proximal-distal axis.

[0170] Example 22. The system of example 21, wherein the system for burrowing further comprises: a spring in contact w ith the proximal end of the first elongated tip; and a line in connection w ith the proximal end of the first elongated tip and extending in the proximal direction.

[0171] Example 23. The system of example 22, wherein the spring is within a compartment at the proximal end of the second elongated tip.

[0172] Example 24. The system of example 22 or 23, wherein the system for burrowing is capable of incrementally traverse through a tissue as follows: the second elongated tip distally advances a distance, the distance defined by a length and compression of the spring; as the second elongated tip distally advances, the first elongated tip remains held in place by the line being taut, resulting in compression of the spring; and the tautness of the line is loosened, allowing the spring to decompress such that the first elongated tip advances the distance.

[0173] Example 25. The system of any one of examples 21 to 24 further comprising an ablation catheter ensheathed within the outer sheath.

[0174] Example 26. A method of traversing a catheter through a tissue, the method comprising: delivering a transcatheter system to a site of tissue, the transcatheter system comprising: an outer sheath having a proximal-distal axis; an inner sheath ensheathed within the outer sheath; and a burrowing system comprising: two cooperative elongated tips in connection with a distal end of the inner sheath, wherein the two cooperative elongated tips comprise a first elongated tip and a second elongated tip, each tip tapering to a point at the distal end, wherein the first elongated tip comprises a set of barbs, each barb angled back in the proximal direction, and wherei n the first elongated tip and the second elongated tip are able to independently move relative to one another along the proximal-distal axis; a spring within a compartment at the proximal end of the second elongated tip, the spring also in contact with the proximal end of the first elongated tip; and a line in connection w ith the proximal end of the first elongated tip and extending in the proximal direction; distally advancing the burrowing system to traverse into the tissue; and incrementally distally advancing the burrowing system to traverse deeper into tissue.

[0175] Example 27. The method of example 26, wherein the step of incrementally distally advancing comprises: distally advancing the second elongated tip a distance, the distance defined by a length and compression of the spring; wherein as the second elongated tip distally advances, the first elongated tip remains held in place by the line being taut,resulting in compression of the spring; and distally advancing the first elongated tip the distance by loosening the tautness of the line, allowing the spring to decompress.

[0176] Example 28. The method of example 26 or 27, wherein the transcatheter system further comprises an ablation catheter, the method further comprising: ablating tissue by distally advancing the ablation catheter along the inner sheath up to the distal end of the burrowing system, yielding a tract of ablated tissue.

[0177] Example 29. The method of example 28 further comprising proximally retracting the burrowing system through the tract of ablate tissue.

[0178] Example 30. The method of any one of examples 26 to 29, wherein the transcatheter system reaches the site of tissue via a transfemoral approach, a subclavian approach, a transapical approach, or a transaortic approach.

[0179] Example 31. A dual transcatheter system for excising and repairing tissue, the system comprising: an outer sheath having a proximal-distal axis, the outer sheath comprising an elongated aperture at a distal end of the outer sheath and a closed distal tip; a tissue mass excision system within the outer sheath and capable of excising tissue through the elongated aperture, the tissue mass excision system comprising a tool with a sharp edge and a compartment capable of capturing excised tissue therein; and a suturing system situated within the elongated aperture, the suturing system comprising a plurality of needles, each needle having a needle tip and an inner lumen with a traversing suture within the inner lumen, wherein each of the needles are attached to a needle holder that is an elongated rod.

[0180] Example 32. The system of example 31, wherein the tool comprises a rounded bowl at the distal end, wherein the sharp edge is at least a portion of an edge of the rounded bowl, and wherein the rounded bow comprises a rounded back and a partially open face opposite of the rounded back to form the compartment.

[0181] Example 33. The system of example 31 or 32 further comprising: a suturing driver situated proximally positioned relative to the suturing the system, wherein the suturing driver comprises a torqueing rod that is in connection with the needles via the needle holder, and wherein circular turning of the torqueing rod results in the needles turning in a circular motion.

[0182] Example 34. The system of example 33, wherein the suturing driver is within the outer sheath.

[0183] Example 35. The system of example 33, wherein the suturing driver is extracorporeal.

[0184] Example 36. The system of any one of claims example 31-35, wherein each traversing suture comprises a suture loop at the ends of the suture.

[0185] Example 37. The system of example 36, wherein the outer sheath comprises a channel and a plurality of notches with i n its side wall, wherein each notch is designed to fit and position the suture loop therein such that the suture loop is aligned with the channel.

[0186] Example 38. The system of example 37 further comprising a suture positioning shaft that is situated near and extended along the needle holder, wherein the positioning shaft is capable of position a suture loop within its respective notch by moving the suture positioning shaft in a circular direction.

[0187] Example 39. The system of example 38, wherein each needle comprises a suture positioning channel, wherein the positioning shaft traverses through each suture positioning channel, and wherein each suture positioning channel limits circular motion of the suture positioning shaft.

[0188] Example 40. The system of example 38, wherein the suture positioning shaft traverses through the suture loops that are to be positioned within its respective notch.

[0189] Example 41. A method for excising and repairing tissue, the method comprising: advancing a transcatheter system to a site to tissue to be excised, wherein the transcatheter system comprises an outer sheath, a tissue mass excision system, a suturing system, and a suturing driver; wherein the outer sheath comprises an elongated aperture at a distal end, a closed distal tip, and a final suture channel; wherein the tissue mass excision system is within the outer sheath and capable of excising tissue through the elongated aperture, and wherein the tissue mass excision system comprising a tool with a sharp edge and a compartment capable of capturing excised tissue therein; wherein the suturing system is situated within the elongated aperture and comprises a plurality needles, each needle having a needle tip and an inner lumen w ith a traversing suture within the inner lumen, wherein each of the needles are attached to a needle holder that is an elongated rod, and wherein each traversing suture has first suture loop on one end of the suture and second suture loop on another end of the suture; and wherein the suturing driver is situated proximally positioned relative to the suturing the system, wherein the suturing driver comprises a torqueing rod that is in connection with the needles via the needle holder; situating the elongated aperture, the tissue mass excision system, and suturing system over the site of tissue; excising a mass of tissue using the tissue mass excision system; and repairing tissue remaining adjacent to the tissue mass that was excised.

[0190] Example 42. The method of example 41, wherein the step of excising a mass of tissue comprises cutting the tissue mass with the sharp edge and capturing the tissue withinthe compartment; wherein the step of repairing tissue comprises turning the torqueing rod in a first circular motion such that the plurality of needles move to penetrate and traverse through an injury and / or an opening, wherein the circular motion of the needles results in the each of the traversing sutures to traverse through the tissue at the site of excision.

[0191] Example 43. The method of example 42, wherein each first suture loop is positioned to align with the final suture channel.

[0192] Example 44. The method of any one of examples 41-43, wherein the step of repairing tissue comprises passing a final suture through the final suturing channel and through each first suture loop.

[0193] Example 45. The method of any one of examples 42-44, wherein the step of repairing tissue comprises turning the torqueing rod in a second circular motion that is opposite to the first circular motion such that the plurality of needles retreat back through the tissue at the site of excision; wherein the final suture traversed that is traversed through each first suture loop keeps a plurality of traversing sutures traversed through the tissue at the site of excision; and wherein each second suture loop is positioned to align with the final suture channel.

[0194] Example 46. The method of any one of examples 41-45, wherein the step of repairing tissue comprises passing the final suture through the final suturing channel and through each second suture loop.

[0195] Example 47. The method of any one of examples 41-46, wherein the step of repairing tissue comprises cinching the plurality of traversing sutures via the final suture to close an injury and / or an opening.

[0196] Example 48. The method of any one of examples 41-47, wherein the suturing system further comprises a suture positioning shaft that is situated near and extended along the needle holder, wherein the suture positioning shaft traverses through the suture loops; and wherein the positioning of each first suture loop is positioned by moving the suture positioning shaft.

[0197] Example 49. The method of any one of examples 45-48, wherein the plurality of traversing sutures is cinched via a pledget.

[0198] Example 50. The method of any one of examples 41-49, further comprising utilizing a transfemoral approach, a subclavian approach, a transapical approach, or a transaortic approach to reach the site of excision.

[0199] Example 51. A system for stretching tissue, comprising: a first strut; a second strut connected to the first strut via a hinge; a first anchor in connection with a peripheralend of the first strut; and a second anchor in connection with a peripheral end of the second strut.

[0200] Example 52. The system of example 51 further comprising a component for locking the hinge at or near 180°.

[0201] Example 53. The system of example 52, wherein the component is a pin, a cap, or a sleeve.

[0202] Example 54. The system of example 51, wherein the first anchor and the second anchor are each a helical screw.

[0203] Example 55. A method for stretching tissue, comprising: positioning a stretching system over a tissue to be stretched, wherein the stretching system comprises: a first strut, a second strut connected to the first strut via a hinge, a first anchor in connection with a peripheral end of the first strut, and a second anchor in connection with a peripheral end of the second strut; anchoring the stretching system over the tissue to be stretched via the first anchor and the second anchor; straightening the hinge to at or about 180°; and locking the hinge in the straightened position.

[0204] Example 56. A system for stretching tissue, comprising: a first strut; a second strut, wherein the first strut and the second strut crossover; a pivot positioned where the first strut and the second strut crossover; a set of four anchors, each anchor at an end of the first strut and at an end of the second strut; and a set of perimeter struts with a means for elongating or shortening, the set of perimeter struts connect one end the first strut with one end of the second strut.

[0205] Example 57. The system of example 56, wherein the pivot is a pin.

[0206] Example 58. The system of examples 56 or 57, wherein the set of four anchors comprises a helical screw.

[0207] Example 59. The system of example 58, wherein the means for elongating or shortening are a set of gears, a rack and pinion, or two slidable members.

[0208] Example 60. A method of stretching tissue, comprising: positioning a stretching system over a tissue to be stretched, wherein the stretching system comprises: a first strut, a second strut, wherein the first strut and the second strut crossover, a pivot positioned where the first strut and the second strut crossover, a set of four anchors, each anchor at an end of the first strut and at an end of the second strut, and a set of perimeter struts with a means for elongating or shortening, the set of perimeter struts connect one end the first strut with one end of the second strut; anchoring the stretching system over the tissue to be stretched viathe set of four anchors; and elongating the stretching system in one dimension using the means for elongating or shortening.

[0209] Example 61. A transcatheter system that extends along a proximal-distal axis for excising tissue, comprising: a controller, a perimeter blade system, a traversing blade system, a grasper, and a sheath, wherein the sheath ensheathes the perimeter blade system, the traversing blade system, and the grasper; wherein the grasper comprises sharp piercing tip at its distal end and is configured to grasp tissue; wherein the perimeter blade system comprises one or more perimeter blades, each perimeter blade in connection w ith the controller via a perimeter-blade torqueing connector, wherein the perimeter blade system is peripheral to the grasper within the sheath and each perimeter blade is configured to encircle the grasper via the perimeter-blade torqueing connector; wherein the traversing blade system comprises one or more traversing blades, each traversing blade in connection w ith the controller via a push -ware connector, wherein the traversing blade system is peripheral to the grasper wdthin the sheath and each traversing blade is configured traverse across a plane that is orthogonal to the proximal-distal axis.

[0210] Example 62. The system of example 61, wherein the grasper is in connection with the controller via a torqueing connector.

[0211] Example 63. The system of example 62, wherein the controller is configured to distally advance, proximally retract, and rotate the grasper via the torqueing connector.

[0212] Example 64. The system of example 63, w herein the controller is configured to distally advance, proximally retract, and rotate the grasper independent of the perimeter blade system.

[0213] Example 65. The system of example 63, wherein the controller is configured to distally advance, proximally retract, and rotate the grasper in conjunction with the perimeter blade system.

[0214] Example 66. The system of any one of examples 61-65, wherein the grasper comprises a helical coil, a barbed spear, a hook, or a screw.

[0215] Example 67. The system of any one of examples 61-66, wherein the grasper comprises a hard-stop component at its proximal end.

[0216] Example 68. The system of example 67, wherein the hard-stop component is a disc, a plate, or a flange.

[0217] Example 69. The system of example 67 or 68, wherein the hard-stop component comprises notches or through-holes to allow distal advancement and proximal retraction of the perimeter blade system.

[0218] Example 70. The system of any one of examples 61-69, wherein each perimeter blade comprises one or more sharp edges configured to cut tissue when distally advanced.

[0219] Example 71. The system of any one of examples 61-70, wherein each perimeter blade comprises one or more sharp edges configured to cut tissue when encircling the grasper.

[0220] Example 72. The system of example 71, wherein the controller is configured to distally advance, proximally retract, and rotate the perimeter blade system independent of the grasper.

[0221] Example 73. The system of any one of examples 61-72, wherein each traversing blade is composed of a shape-memory material and preloaded to bend inward from an outer perimeter.

[0222] Example 74. The system of any one of examples 61-73, wherein each traversing blade is configured to be sheathed within a perimeter blade within an internal channel.

[0223] Example 75. The system of example 74, wherein each traversing blade is configured to bend inward as it is distally advanced out of the internal channel.

[0224] Example 76. A method for excising tissue using a transcatheter system that extends along a proximal-distal axis, comprising: delivering the transcatheter system to a site of cardiovascular tissue to be excised within a recipient, the transcatheter system comprising: a controller, a perimeter blade system, a traversing blade system, a grasper, and a sheath, wherein the sheath ensheathes the perimeter blade system, the traversing blade system, and the grasper; wherein the sheath ensheathes the perimeter blade system, the traversing blade system, and the grasper; wherein the grasper comprises sharp piercing tip at its distal end and is configured to grasp tissue; wherein the perimeter blade system comprises one or more perimeter blades, each perimeter blade in connection with the controller via a perimeter-blade torqueing connector, wherein the perimeter blade system is peripheral to the grasper within the sheath and each perimeter blade is configured to encircle the grasper via the perimeter-blade torqueing connector; wherein the traversing blade system comprises one or more traversing blades, each traversing blade in connection with the controller via a push-wire connector, wherein the traversing blade system is peripheral to the grasper within the sheath and each traversing blade is configured traverse across a plane that is orthogonal to the proximal-distal axis; distally advancing the grasper into the tissue; distally advancing the perimeter blade system into the tissue; distally advancing the traversing blade system into the tissue such that each traversing blade traverses through tissue in a direction orthogonal to the proximal-distal axis; rotating theperimeter blade and traversing blade such that it cuts through the tissue; proximally retracting the torqueing connector such that the tissue is excised.

[0225] Example 77. The method of example 76, wherein the grasper is in connection w ith the controller via a torqueing connector.

[0226] Example 78. The method of examples 76 or 77, wherein the controller is configured to distally advance, proximally retract, and rotate the grasper via the torqueing connector.

[0227] Example 79. The method of any one of examples 76-78, wherein the controller is configured to distally advance, proximally retract, and rotate the grasper independent of the perimeter blade sy stem.

[0228] Example 80. The method of any one of examples 76-78, wherein the controller is configured to distally advance, proximally retract, and rotate the grasper in conjunction w ith the perimeter blade system.

[0229] Example 81. The method of any one of examples 76-80, wherein the grasper comprises a helical coil, a barbed spear, a hook, or a screw.

[0230] Example 82. The method of any one of examples 76-81, wherein the grasper comprises a hard-stop component at its proximal end.

[0231] Example 83. The method of example 82, wherein the hard-stop component is a disc, a plate, or a flange.

[0232] Example 84. The method of example 82 or 83, wherein the hard-stop component comprises notches or through-holes to allow distal advancement and proximal retraction of the perimeter blade system.

[0233] Example 85. The method of any one of examples 76-84, w herein each perimeter blade comprises one or more sharp edges configured to cut tissue when distally advanced.

[0234] Example 86. The method of any one of examples 76-85, w herein each perimeter blade comprises one or more sharp edges configured to cut tissue w hen encircling the grasper.

[0235] Example 87. The method of example 86, wherein the controller is configured to distally advance, proximally retract, and rotate the perimeter blade system independent of the grasper.

[0236] Example 88. The method of any one of examples 76-87, wherein each traversing blade is composed of a shape-memory7material and preloaded to bend inward from an outer perimeter.

[0237] Example 89. The method of any one of examples 76-88, wherein each traversing blade is configured to be sheathed within a perimeter blade w ithin an internal channel.

[0238] Example 90. The method of example 89, wherein each traversing blade is configured to bend inward as it is distally advanced out of the internal channel.

Claims

WHAT IS CLAIMED IS:

1. A transcatheter system for excising tissue, comprising: an outer sheath having a proximal-distal axis; and a blade system ensheathed within the outer sheath, the blade system comprising a set of two or more blades, each blade laterally curved and overlapping another blade on each lateral side such that the set of blades form a tubular shape; the blade system further comprising an inner sandwich sheath ensheathed within the set of blades; wherein the blade system is capable of moving independently of the outer sheath along the proximal-distal axis; and wherein the set of blades, the inner sandwich sheath, are each capable of moving independently along the proximal -distal axis.

2. The system of claim 1, wherein each blade has a tapered edge to form a vertex at a distal end.

3. The system of claim 2, wherein each distal tip of each blade is configured to collapse inward, the set of blades forming a conical shape when collapsed.

4. The system of claim 2 or 3, wherein each blade is composed of a shape memory material, the shape memory material having a memory to yield an inward collapse force.

5. The system of claim 4, w herein the inner sandwich sheath is capable of being positioned to prevent the inward collapse force.

6. The system of any one of claims 1-5 further comprising a suture system that comprises: a helical coil that extends along the proximal-distal axis, wherein the helical coil comprises a hollowed inner lumen; an anchor positioned at a distal end of the helical coil; and a suture attached to the anchor and extended through the inner lumen of the helical coil.

7. The system of claim 6, wherein the suture system and the blade system are each capable of moving independently along the proximal-distal axis relative to one another.

8. The system of claim 7, wherein the suture system can be rotated w hile being distally advanced or proximally retracted.

9. The system of claim 6, 7, or 8, wherein the anchor has a sharp distal tip and barbs.

10. The system of any one of claims 6-9, wherein the suture system further comprises a pusher that extends through the inner lumen of the helical coil.

11. A method for excising tissue, comprising: delivering a transcatheter system to a site of cardiovascular tissue to be excised within a recipient, the transcatheter system comprising: an outer sheath having a proximal-distal axis; and a blade system ensheathed with i n the outer sheath, the blade system comprising a set of two or more blades, each blade laterally curved and overlapping another blade on each lateral side such that the set of blades form a tubular shape; the blade system further comprising an inner sandwich sheath ensheathed within the set of blades; wherein the blade system is capable of moving independently of the outer sheath along the proximal-distal axis; and w herein the set of blades, the inner sandwich sheath, are each capable of moving independently along the proximal-distal axis; distally advancing the set of blades with the inner sandwich sheath into the tissue yielding a tract of tissue within a lumen of the set of blades; proximally retracting the inner sandwich sheath, allowing a distal tip of each blade to collapse inw ard such that the distal tip of each blade comes together upon collapsing, encapsulating the tract of tissue therein; and proximally retracting the blade system such that the tract of tissue is excised.

12. The method of claim 11, wherein each blade has a tapered edge to form a vertex at a distal end.

13. The method of claim 11 or 12, wherein each blade is composed of a shape memory material, the shape memoiy material having a memory to yield an inward collapse force.

14. The method of claim 11, 12, or 13, wherein the step of distally advancing the set of blades further comprises rotating the blades in a circular direction.

15. The method of any one of claims 11-14, wherein the step of proximally retracting the inner sandwich sheath further comprises rotating the blades in a circular direction.

16. The method of any one of claims 11-15, wherein the system further comprises a suture system that comprises: a helical coil that extends along the proximal-distal axis, wherein the helical coil comprises a hollowed inner lumen;an anchor positioned at a distal end of the helical coil; and a suture attached to the anchor and extended through the inner lumen of the helical coil; the method further comprising: distally advancing the suture system through peri-tract tissue; releasing the anchor within the peri-tract tissue; proximally retracting the suture system back out of the peri-tract tissue such that the anchor and suture remain within the peri-tract tissue; tightening the suture to gather the peri-tract tissue; and securing the suture to the peri-tract tissue.

17. The method of claim 16, wherein the step distally advancing the suture system through peri-tract tissue comprises turning the helical coil in a circular direction.

18. The method of claim 16 or 17, wherein the step distally advancing the suture system through peri-tract tissue is performed prior to the step of proximally retracting the blade system.

19. The method of claim 16, 17, or 18, wherein the step of proximally retracting the suture system back out of the peri-tract tissue comprises turning the helical coil in a circular direction.

20. The method of any one of claims 11 to 19, wherein the transcatheter system reaches the site of tissue to be excised with in the cardiovascular system via a transfemoral approach, a subclavian approach, a transapical approach, or a transaortic approach.

21. A transcatheter system for burrowing into a tissue, comprising: an outer sheath having a proximal-distal axis; an inner sheath ensheathed within the outer sheath; and a system for burrowing in connection with a distal end of the inner sheath, the system for burrowing comprising two cooperative elongated tips, wherein the two cooperative elongated tips comprise a first elongated tip and a second elongated tip, each tip tapering to a point at the distal end; wherein the first elongated tip comprises a set of barbs, each barb angled back in the proximal direction; wherein the first elongated tip and the second elongated tip are able to independently move relative to one another along the proximal-distal axis.

22. The system of claim 21, wherein the system for burrowing further comprises: a spring in contact with the proximal end of the first elongated tip; anda line in connection w ith the proximal end of the first elongated tip and extending in the proximal direction.

23. The system of claim 22, wherein the spring is within a compartment at the proximal end of the second elongated tip.

24. The system of claim 22 or 23, wherein the system for burrowing is capable of incrementally traverse through a tissue as follows: the second elongated tip distally advances a distance, the distance defined by a length and compression of the spring; as the second elongated tip distally advances, the first elongated tip remains held in place by the line being taut, resulting in compression of the spring; and the tautness of the line is loosened, allowing the spring to decompress such that the first elongated tip advances the distance.

25. The system of any one of claims 21 to 24 further comprising an ablation catheter ensheathed within the outer sheath.

26. A method of traversing a catheter through a tissue, the method comprising: delivering a transcatheter system to a site of tissue, the transcatheter system comprising: an outer sheath having a proximal-distal axis; an inner sheath ensheathed w ithin the outer sheath; and a burrowing system comprising: two cooperative elongated tips in connection with a distal end of the inner sheath, wherein the two cooperative elongated tips comprise a first elongated tip and a second elongated tip, each tip tapering to a point at the distal end, w herein the first elongated tip comprises a set of barbs, each barb angled back in the proximal direction, and w herein the first elongated tip and the second elongated tip are able to independently move relative to one another along the proximal -distal axis; a spring within a compartment at the proximal end of the second elongated tip, the spring also in contact with the proximal end of the first elongated tip; and a line in connection with the proximal end of the first elongated tip and extending in the proximal direction; distally advancing the burrowing system to traverse into the tissue; and incrementally distally advancing the burrowing system to traverse deeper into tissue.

27. The method of claim 26, wherein the step of incrementally distally advancing comprises: distally advancing the second elongated tip a distance, the distance defined by a length and compression of the spring; wherein as the second elongated tip distally advances, the first elongated tip remains held in place by the line being taut, resulting in compression of the spring; and distally advancing the first elongated tip the distance by loosening the tautness of the line, allow ing the spring to decompress.

28. The method of claim 26 or 27, wherein the transcatheter system further comprises an ablation catheter, the method further comprising: ablating tissue by distally advancing the ablation catheter along the inner sheath up to the distal end of the burrowing system, yielding a tract of ablated tissue.

29. The method of claim 28 further comprising proximally retracting the burrowing system through the tract of ablate tissue.

30. The method of any one of claims 26 to 29, wherein the transcatheter system reaches the site of tissue via a transfemoral approach, a subclavian approach, a transapical approach, or a transaortic approach.

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