Devices and methods for allowing large bore transseptal access and subsequent re-access to the atrium

Abstract

The present invention relates to medical devices. More specifically, the present invention describes a vascular device that allows large bore transseptal access with subsequent re-entry into the atrium by pre-placing a closure / tissue access suture prior to performing an atrial septostomy. Generally, the device can include a delivery catheter for puncturing and cutting the atrial septum. An anchor of the delivery catheter can secure the suture in the atrium to the septal wall, e.g., the left atrium. The incision can be formed by an expandable cutting tool that can use mechanical or radiofrequency (RF) energy without disturbing the suture. After the cutting tool forms the incision, a therapeutic device can be advanced through the tissue plane. The incision can be closed with the previously placed suture.

Description

[0001] Related applications

[0002] This invention claims priority to U.S. Provisional Application No. 63 / 036,435, filed June 8, 2020, entitled “Large Bore Septal Closure” and U.S. Provisional Application No. 62 / 873,383, filed July 12, 2019, entitled “Large Bore Atrial Preclose”, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This invention relates to medical devices, and more specifically, to a technique for transcatheter delivery of atrial septum crossing and closure of a large-diameter device that allows access to the atria (e.g., the left atrium) and subsequently re-enter the atria. Background Technology

[0004] A more common approach to left ventricular catheterization is to use a mechanical or radiofrequency (RF) powered needle to puncture and pass through the interatrial septum. For small-bore catheters (typically less than 24 French), the procedure is usually direct. However, if a larger catheter or opening is to be passed through the interatrial septum, puncture site dilation is typically used to allow the catheter to pass through. Current methods for dilating the initial septal puncture site may involve using a dilator or opening the entry site via a dilation balloon. This may require the physician to change tools multiple times, and due to the uncontrolled nature of the dilation technique, it can have adverse effects on the tissue.

[0005] Furthermore, minimally invasive, catheter-based therapies are under development, enabling physicians to treat patients with pre-existing comorbidities who may be unable to undergo the more invasive procedures they require. In recent years, catheter-based procedures have been developed that may involve the implantation of a mitral valve for repair or replacement, potentially using a large-bore transseptal approach. Transseptal puncture can lead to the formation of an iatrogenic atrial septal defect, which may subsequently require closure with an atrial septal defect device. However, the atrial septal defect device may prevent or make subsequent transseptal traversal difficult.

[0006] This invention provides a device and method for allowing large-diameter transseptal access and subsequent atrial re-entry, addressing the aforementioned problems. This document describes a controlled and precise atrial septostomy that allows a large-diameter device to pass through the atrial septum and then provide rapid and permissive closure of a procedurally generated atrial septal defect. The term "permissive" can be defined as a mechanism that closes the atrial septal defect and allows future passage through the atrial septum via a standard transseptal method. Other benefits and advantages will become clear from the disclosure provided herein, and those advantages are provided for illustrative purposes. The statements in this section provide only background information relevant to the invention and do not constitute prior art. Summary of the Invention

[0007] This summary is provided to introduce some concepts in a simplified form, which will be further described in the following detailed description of embodiments. This summary is not intended to identify key features of the claimed subject matter, nor is it intended to help determine the scope of the claimed subject matter.

[0008] According to one aspect of the invention, a vascular device for performing trans-segmental puncture is provided. The device may include a body, an anchor extending from the distal end of the body through an axis disposed within the body, at least one suture connected to at least one needle within the anchor, at least one catch extending from the body to pull the at least one needle into the body for placing the at least one suture, and a cutting tool connected between the body and the anchor to an actuating axis aligned with the at least one suture.

[0009] According to another aspect of the invention, a septal opening closure device that allows re-entry is provided. The device may include a body located on a first side of a septal opening in a cardiac septum, an anchor located on a second side of the septal opening extending from a distal end of the body through a shaft disposed within the body, at least one suture connected to at least one needle disposed within the anchor, at least one hook extending from the body to pull the at least one needle into the body for placing the at least one suture, and a cutting tool located between the body and the anchor, the cutting tool being connected to an actuation shaft aligned with the at least one suture.

[0010] According to another aspect of the invention, a vascular closure device is provided. The device may include an anchor positioned through a perforation in the vessel wall and operable from a body between a retracted position and an expanded position; at least one suture disposed within the anchor; at least one needle connected to the at least one suture, the needle extending through the vessel wall adjacent to the perforation to connect the at least one suture when the anchor is in the expanded position; at least one hook extending from the body to pull the at least one needle into the body for placing the at least one suture; and a cutting tool located between the body and the anchor, the cutting tool being connected to an actuation shaft aligned with the at least one suture.

[0011] According to another aspect of the invention, a method for intermittent traversal of a blood vessel wall is provided. The method may include providing a delivery catheter having a body and an anchor, inserting the anchor through a perforation in the blood vessel wall, manipulating the anchor into an expanded position, capturing the blood vessel wall between the body and the anchor to expose at least one needle, capturing the at least one needle through the blood vessel wall adjacent to the perforation and engaging it with at least one suture, and positioning the at least one suture within the blood vessel wall.

[0012] According to one aspect of the invention, a vascular device is provided. The device may include a delivery system having at least one anchor penetrating a tissue plane, the at least one anchor having a suture, a cutting tool positioned in the tissue plane to facilitate an incision, a treatment device advanced into the incision, and fasteners securing the suture to the tissue plane.

[0013] According to another aspect of the invention, a spacer hole closure device is provided. The device may include a first pledget introduced into a tissue plane via a cannula, wherein the first pledget is connected to a control line for tensioning the first pledget after introduction into the tissue plane; a second pledget introduced into the tissue plane via a cannula, wherein the second pledget is connected to a control line for tensioning the second pledget after introduction into the tissue plane; a cutting tool forming an incision between the first and second pledgets; a treatment device passing through the incision; and a knot made of the control lines of the first and second pledgets, the knot tensioning the first and second pledgets and tissue from the tissue plane between them.

[0014] According to another aspect of the invention, an apparatus for puncturing a patient's interatrial septum is provided. The apparatus may include a body, a tip extending distally from the body, and a retracted cutting member disposed between the body and the tip, wherein the cutting member follows the tip into a tissue plane, and expands after passing through the tissue plane.

[0015] According to one aspect of the present invention, a vascular device is provided. The device may include a delivery system, a tip extending distal to the delivery system, and a cutting tool disposed between the delivery system and the tip.

[0016] According to another aspect of the invention, a method for treating a left atrial septum is provided. The method may include puncturing the septum with a needle, placing at least one suture behind the septum, advancing a treatment device into the perforation, and tightening the at least one suture to close the perforation.

[0017] According to another aspect of the invention, a method for closing a spacer hole is provided. The method may include forming a spacer entry through a thread, inserting a delivery conduit along the thread, expanding the spacer entry by a cutting tool of the delivery conduit, inserting at least one suture connected to a needle that passes around the spacer entry, securing the spacer entry with at least one suture, and removing the delivery conduit. Attached Figure Description

[0018] Novel features considered characteristic of the invention are set forth in the appended claims. In the following description, similar portions are denoted by the same numbers throughout the specification and drawings. The drawings are not necessarily drawn to scale, and some figures may be shown in exaggerated or generalized form for clarity and brevity. However, the invention itself, its preferred modes of use, further objects, and advantages will be better understood when read in conjunction with the drawings, by referring to the following detailed description of illustrative embodiments, in which:

[0019] Figure 1 is a frontal schematic diagram of an illustrative human venous circulation system in a patient according to one aspect of the present invention, wherein a guidewire enters the right atrium from the femoral vein;

[0020] Figure 2 is a frontal schematic diagram of an illustrative human venous circulation system in a patient according to one aspect of the present invention, wherein an exemplary vascular device is advanced into the right atrium;

[0021] Figure 3 is a cross-sectional view of the heart according to one aspect of the present invention, wherein an exemplary vascular device is located at the interatrial septum, and an interatrial septal puncturist passes through the interatrial septum into the left atrium;

[0022] Figure 4 is a cross-sectional view of the heart according to one aspect of the present invention, wherein an exemplary vascular device passes through the interatrial septum into the left atrium, and the interatrial septal puncturist is removed.

[0023] Figure 5 is a cross-sectional view of the heart, illustrating an exemplary initial incision according to one aspect of the invention, which was subsequently extended;

[0024] Figure 6 is a schematic side view of an exemplary vascular device according to one aspect of the present invention;

[0025] Figure 7 is an isometric view of the distal end of an exemplary vascular device in a low-profile state according to one aspect of the present invention.

[0026] Figure 8 is an axonometric view of the distal end of an exemplary vascular device viewed from different perspectives according to one aspect of the invention, wherein a portion of the device is advanced, showing components for puncturing tissue and passing through sutures;

[0027] Figure 9 is an axonometric view of the distal end of an exemplary vascular device according to one aspect of the present invention, a portion of which is advanced through tissue of the interatrial septum;

[0028] Figure 10 is a cross-sectional view of an exemplary vascular device according to one aspect of the present invention, the vascular device having an exemplary cavity structure;

[0029] Figure 11 is an axonometric sectional view of the distal end of an exemplary vascular device according to one aspect of the present invention, showing the internal geometry of the components therein;

[0030] Figure 12 is an axonometric view of the distal end of an exemplary vascular device according to one aspect of the present invention, showing a snare that has been pushed out of the body of the vascular device;

[0031] Figure 13 is an isometric view of the distal end of an exemplary vascular device after four suture needles and suture ends have passed through the tissue, looped around and pulled through the length of the device, according to one aspect of the invention.

[0032] Figure 14 is an axonometric view of the distal end of an exemplary vascular device according to one aspect of the invention, wherein the suture has been fully pulled through the length of the device and is now taut against the tissue;

[0033] Figure 15 is an isometric view of the distal end of the vascular device of the cutting element after the cutting tool has been partially advanced, according to one aspect of the invention.

[0034] Figure 16 is an isometric view of the distal end of a vascular device expanded by a cutting tool according to one aspect of the present invention;

[0035] Figure 17 is an isometric view of an exemplary vascular device positioned for cutting tissue according to one aspect of the present invention;

[0036] Figure 18 is an isometric view of a suture to be inserted into tissue according to one aspect of the present invention;

[0037] Figure 19 is an axonometric view of an incision after the tissue and suture have joined, according to one aspect of the invention.

[0038] Figures 20A-L illustrate various exemplary cutting patterns that can be formed using vascular devices in the interatrial septum according to one aspect of the present invention, the cutting patterns being made by at least one rotatable and reusable cutting tool.

[0039] Figure 21 is an isometric view of an exemplary cutting pattern for making an incision to facilitate tissue edge attachment according to one aspect of the present invention;

[0040] Figure 22 is an isometric view of an exemplary cutting pattern for promoting tissue edge juxtaposition under slight tension, according to one aspect of the invention, illustrating tissue edge control and edge overlap when tension is applied;

[0041] Figure 23 is an isometric view of a cutting pattern for promoting tissue edge juxtaposition and an exemplary spiral anchor for controlling tissue edges according to one aspect of the present invention.

[0042] Figure 24 is an isometric view of an exemplary scalable radio frequency (RF) cutting tool having four scalable components according to one aspect of the present invention;

[0043] Figure 25 is an isometric view of an exemplary vascular device according to one aspect of the present invention, the vascular device having an expandable cutting tool having a tip for piercing tissue;

[0044] Figure 26 is an isometric view of an exemplary vascular device according to one aspect of the present invention, wherein an exemplary expandable cutting tool is placed outside the tissue;

[0045] Figure 27 is an isometric view of an exemplary vascular device according to one aspect of the present invention, wherein an exemplary expandable cutting tool forms an incision in tissue;

[0046] Figure 28 is an isometric view of an exemplary vascular device according to one aspect of the present invention, the vascular device having an exemplary expandable cutting tool with a propulsion anchor mechanism;

[0047] Figure 29 is an isometric view of an exemplary vascular device according to one aspect of the present invention, the vascular device having an exemplary expandable cutting tool having a propulsion anchor for further insertion to advance an anchor mechanism;

[0048] Figure 30 is an isometric view of an exemplary vascular device with the anchor mechanism removed according to one aspect of the present invention;

[0049] Figure 31 is an isometric view of an exemplary cutting tool according to one aspect of the invention, which is removed from tissue, leaving the tissue anchored thereto;

[0050] Figure 32 is an isometric view of an exemplary elbow within an organization according to one aspect of the present invention;

[0051] Figure 33 is an isometric view of an exemplary cutting tool according to one aspect of the present invention, the cutting tool having a damage-resistant tip extending from an exemplary vascular device;

[0052] Figure 34 is an isometric view of an exemplary cutting tool according to one aspect of the present invention, the cutting tool having a slit in a sheath unfolded from an exemplary vascular device;

[0053] Figure 35 is a side view of an exemplary cutting tool according to one aspect of the present invention, the cutting tool having a cutting element extending from a slit in a sheath;

[0054] Figure 36 is an isometric view of the distal end of an exemplary cutting tool according to one aspect of the present invention;

[0055] Figure 37 is a cross-sectional view of a cutting tool according to one aspect of the present invention;

[0056] Figures 38A-E are schematic diagrams illustrating how, according to one aspect of the present invention, an exemplary cutting tool can be used to optimize cutting performance and minimize power input;

[0057] Figure 39 is an isometric view of an exemplary tissue through which an exemplary guidewire passes according to one aspect of the present invention;

[0058] Figure 40 is an isometric view of a stitching anchor in a delivery sheath according to one aspect of the present invention;

[0059] Figure 41 is an isometric view of a schematic suture anchor in a delivery sheath according to one aspect of the invention, the suture anchor being to penetrate tissue;

[0060] Figure 42 is an isometric view of an exemplary suture anchor in a delivery sheath that joins or penetrates tissue according to one aspect of the present invention;

[0061] Figure 43 is an isometric view of an exemplary suture anchoring tissue in a delivery sheath, with a suture control line connected, according to one aspect of the present invention.

[0062] Figure 44 is an isometric view of an exemplary cutting tool in the sheath position according to one aspect of the present invention;

[0063] Figure 45 is an isometric view of an exemplary cutting tool in the unsheathed position according to one aspect of the present invention;

[0064] Figure 46 is an isometric view of an exemplary cutting tool in the unsheathed position and unfolded according to one aspect of the present invention;

[0065] Figure 47 is an isometric view of an exemplary cutting tool for forming incisions or cuts in tissue according to one aspect of the present invention;

[0066] Figure 48 is an isometric view of an exemplary incision or cut in an organ according to one aspect of the present invention, wherein a guide wire passes through the incision or cut.

[0067] Figure 49 is an axonometric view of an exemplary treatment device advancing through an incision in tissue on a guidewire, according to one aspect of the present invention.

[0068] Figure 50 is an isometric view of an exemplary tissue anchor with a helical barb according to one aspect of the present invention;

[0069] Figure 51 is an isometric view of an exemplary tissue anchor lock according to one aspect of the invention, the lock having a spiral barb that engages in tissue passing through a suture control line;

[0070] Figure 52 is an isometric view of an exemplary tissue anchor lock according to one aspect of the invention, the lock having a spiral barb engaged in the tissue, extending beyond a suture control line trimmed to the level of the anchor;

[0071] Figure 53 is an isometric view of an exemplary tissue anchor according to one aspect of the invention, wherein a helical barb engages on the other side of the tissue;

[0072] Figure 54 is an isometric view of an exemplary gasket made of a biocompatible or bioabsorbable material according to one aspect of the present invention.

[0073] Figure 55 is an exemplary cannula puncture of cardiac tissue according to one aspect of the present invention;

[0074] Figure 56 is an isometric view of an exemplary cannula advancing through a cannula to puncture cardiac tissue and an exemplary pad made of a biocompatible or bioabsorbable material, according to one aspect of the present invention.

[0075] Figure 57 is an isometric view of an exemplary cannula puncturing cardiac tissue according to one aspect of the present invention and an exemplary pad made of biocompatible or bioabsorbable material extending from the cannula.

[0076] Figure 58 is an isometric view of an exemplary cannula for puncturing cardiac tissue and an exemplary pad made of a biocompatible or bioabsorbable material extending from the cannula, and a control line tensioned to shorten the pad, according to one aspect of the present invention.

[0077] Figure 59 is an axonometric view of an exemplary gasket made of a biocompatible or bioabsorbable material according to one aspect of the invention, the gasket being stretched to shorten the gasket, wherein an exemplary cannula-joint cardiac tissue is removed and retained on the surface of the cardiac tissue.

[0078] Figure 60 is an isometric view of an exemplary concentric pad made of a biocompatible or bioabsorbable material according to one aspect of the present invention.

[0079] Figure 61 is an isometric view of an exemplary cannula according to one aspect of the present invention, the cannula puncturing cardiac tissue next to a gasket;

[0080] Figure 62 is an axonometric view of an exemplary cannula for puncturing cardiac tissue and an exemplary concentric pad made of biocompatible or bioabsorbable material extending from the cannula, according to one aspect of the present invention.

[0081] Figure 63 is an axonometric view of an exemplary cannula puncturing cardiac tissue according to one aspect of the present invention and an exemplary concentric pad made of a biocompatible or bioabsorbable material, the exemplary concentric pad extending from the cannula and being tightened by a controller to shorten the pad.

[0082] Figure 64 is an axonometric view of an exemplary concentric gasket made of a biocompatible or bioabsorbable material according to one aspect of the present invention, the gasket being stretched to shorten the gasket and an exemplary cut formed between the gaskets.

[0083] Figure 65 is an isometric view of an exemplary treatment device placed in an incision between pads in tissue, according to one aspect of the present invention.

[0084] Figure 66 is an isometric view of an exemplary knot with two pad control lines advanced into heart tissue according to one aspect of the present invention;

[0085] Figure 67 is an isometric view of an exemplary knot according to one aspect of the invention, the knot being advanced into the heart tissue by two gasket control lines and tightened from the knot side of the tissue;

[0086] Figure 68 is an isometric view of an exemplary knot advanced into the tissue according to one aspect of the invention, wherein two gasket control lines are pulled taut from the gasket side;

[0087] Figure 69 is an axonometric view of an illustrative cut closed between gaskets according to one aspect of the invention; and

[0088] Figure 70 is an illustrative flowchart illustrating an exemplary process according to one aspect of the invention, which allows for large-bore trans-septal entry followed by atrial re-entry. Detailed Implementation

[0089] The following description, set forth in conjunction with the accompanying drawings, is intended as a description of exemplary embodiments of the invention and is not intended to represent the only form in which the invention can be constructed and / or utilized. This description, in conjunction with the illustrated embodiments, illustrates the order of functions and blocks for constructing and operating the invention. However, it should be understood that the same or equivalent functions and orders can be implemented through different embodiments, which are also intended to be included within the spirit and scope of the invention.

[0090] This invention relates to medical devices. More specifically, the invention describes a vascular device that allows a large-diameter transatrial septum access, followed by re-entry into the atrium, by pre-positioning a closure / tissue proximity suture prior to performing an atrial septostomy. Typically, the device may include a delivery catheter for puncturing and cutting the atrial septum. An anchor in the delivery catheter secures the suture in the atrium to the septum wall, such as the left atrium. The incision can be formed by an expandable cutting tool that can use mechanical or radio frequency (RF) energy without interfering with the suture. The suture may be made of a heat-resistant material to prevent damage upon contact with the cutting tool. After the incision is formed by the cutting tool, the treatment device can be advanced through the tissue plane. The incision can be closed with the previously placed suture.

[0091] From the description provided below, many other modifications or constructions to the vascular device will become apparent. For example, an incision to close the interatrial septum may involve puncturing the septum with a needle and inserting an advance anchor into the tissue. Control lines attached to two or more pads and placed through a cannula across the tissue plane may also be used to facilitate tissue edge overlap and juxtaposition.

[0092] Advantageously, the initial puncture with suture management nearby allows for the rapid closure of iatrogenic atrial septal defects (ASDs) generated during the procedure, while simultaneously allowing multiple devices within a single delivery catheter to enter the atrial septum. The resulting incision is easily tightened, allowing re-entry via anchor / suture. This vascular device can be used in procedures requiring large-bore transvenous access to the left atrium for transcatheter mitral valve replacement, where the delivery system typically generates large residual ASDs. Other benefits and advantages will become clear from the disclosure provided herein, and those advantages are provided for illustrative purposes.

[0093] Figures 1-5 illustrate a human venous circulatory system including a heart with an exemplary vascular device having a guidewire defined therein, while Figures 6-23 depict a first embodiment of a device with an exemplary incision. Figures 24-38 depict a second embodiment of a vascular device with additional illustrative incisions. Figures 39-53 depict a third embodiment with a delivery sheath and a helical anchor for binding tissue together. Figures 54-69 provide a fourth embodiment that positions multiple pads and sutures made of biodegradable material, secured together with knots to allow re-entry. Figure 70 illustrates different techniques. The components described below in the embodiments can be interchanged, removed, or added to each other to obtain derivatives of the device within the scope of the invention.

[0094] Turning to Figure 1, a frontal schematic diagram of an exemplary human venous circulation system for a patient 100 according to one aspect of the invention is provided, wherein a guidewire 102 is routed from the femoral vein 104 to the right atrium 106. The guidewire 102 can be continuously present, thereby allowing for the replacement of multiple tools. For example, these tools can provide placement of pre-closed sutures, followed by controlled atrial septostomy via a retractable blade, and delivery of large-bore catheters or other medical devices to the left atrium.

[0095] Initially, as shown in the figure, the vascular introduction sheath 112 can be inserted into the right femoral vein 104 via percutaneous puncture or incision. Alternatively, the vascular introduction sheath 112 can be placed in a non-femoral location, such as the jugular vein, subclavian artery, subclavian vein, or brachial artery and vein. Other routes or entry sites may include a route from the opposite leg of the treatment catheter.

[0096] Guidewire 102 can be inserted through vascular access sheath 112 and extends cranially upward along the inferior vena cava 110 to the right atrium 106, one of the chambers of heart 108. In this illustration, the left anatomical side of patient 100 faces right. Guidewire 102 can be positioned such that it can be used to introduce a therapeutic or diagnostic catheter into the area of ​​heart 108.

[0097] The venous circulation traversed by guidewire 102 typically operates at pressures lower than the systemic circulation, ranging from 0 to 20 mmHg, with the descending aorta being a part of this system. Systemic circulation pressures can range from 60 mmHg to over 300 mmHg, depending on the level of hypertension or hypotension present in the patient 100. Access to the heart 108 via the femoral vein 104 minimizes the chance of bleeding at the catheter insertion site.

[0098] Figure 2 is a frontal schematic diagram of an illustrative human venous circulation system of a patient 100 according to one aspect of the present invention, wherein an exemplary vascular device 200 is advanced into the right atrium 106. This view is a frontal view taken from the front side of the patient 100. The vascular introduction sheath 112 of Figure 1 has been removed from the right femoral vein 104, and the vascular device 200 has been inserted into the venous circulation via a guidewire 102. The device 200 can be routed through the inferior vena cava 110 into the right atrium 106 of the heart 108 via the same guidewire 102 used with the introduction sheath.

[0099] Referring to FIG3, a cross-sectional view of a heart 108 according to one aspect of the present invention is shown, wherein an exemplary vascular device 200 is located at the interatrial septum 300, and a septal puncturist 304 penetrates the interatrial septum 300 into the left atrium 302. For clarity and illustration of the interatrial septum 300, the ascending aorta, aortic valve, pulmonary artery, and pulmonary valve have been removed from this view. The body of the vascular device 200, substantially located within the right atrium 106, is shown with its long axis perpendicular to the interatrial septum 300. The proximal end of the vascular device 200 is shown located within the inferior vena cava 110. The septal puncturist 304 is shown extending through a perforation 306 in the interatrial septum 300 and entering the left atrium 302 at the distal end of the vascular device 200.

[0100] The septal puncture device 304 can be a needle or an axially elongated structure with a sharp, distal tip. The septal puncture device 304 can be located within the guidewire 102 and is removable. The septal puncture device 304 can be actuated proximally to the vascular device 200 via a control mechanism, such as a button, lever, handle, or trigger, which can be permanently or removably secured via a linkage, push rod, electrical bus, etc., extending along the length of the device 200.

[0101] During the procedure, fluoroscopy, magnetic resonance imaging (MRI), ultrasound, etc., can be used to guide and advance the atrial septum puncturist 304 through the wall of the left atrium 302, which is opposite to the atrial septum 300. Care should be taken to avoid unintentionally puncturing the aorta through the puncturist 304 in areas upstream of or anatomically close to the aortic arch in the patient 100. The distal portion of the vascular device 200 can be bent, deflected, or hinged at an angle between 30 and 120 degrees to achieve approximately perpendicularity to the atrial septum 300.

[0102] The septal puncture device 304 can be solid, hollow like a hypodermic needle, or have a U-shaped or C-shaped cross-section. The center or core of the hollow C- or U-shaped septal puncture device 304 can be filled with a guidewire or other core element to prevent incorrect tissue penetration. The septal puncture device 304 can be rigid or flexible, but maintain column strength. This flexible structure can include incisions or guidewire-like structures on the walls of the puncture device 304. The septal puncture device 304 can initially be straight or initially curved. The septal puncture device 304 can be made of a shape-memory material such as nitinol and is heat-treated to induce bending once the material is heated from a martensitic temperature to an austenitic temperature. This heating can be performed using electric heating, hot water injection, etc. The septal puncture device can utilize energy to facilitate puncture of the septal tissue, such as RF (radio frequency).

[0103] Referring to FIG4, a cross-sectional view of a heart 108 according to one aspect of the invention is shown, wherein an exemplary vascular device 200 passes through the interatrial septum 300 into the left atrium 302, while the interatrial septal trocar is removed. The vascular device 200, which has been distally dilated, has been advanced from the right atrium 106 through the interatrial septum 300 and into the left atrium 302 through a perforation 306. Thus, the distal portion of the vascular device 200 can provide for the placement of a pre-closed suture or other device.

[0104] The proximal region or main body of the vascular device 200 has been advanced so that the proximal region is located not only in the inferior vena cava 110 but also in the right atrium 106. This can be guided by fluoroscopy, magnetic resonance imaging (MRI), ultrasound, etc., as previously described.

[0105] Figure 5 is a cross-sectional view of a heart 108 according to one aspect of the invention, showing illustrative initial incisions 502 or 506, which are subsequently extended to a user-selected / controlled length. A cross-sectional view of the heart 108 as viewed from the right atrium side is shown. The atrial septum 300 may be surrounded by the superior vena cava 512's superior vena cava border 510, the inferior vena cava 110's posterior border 514, inferior vena cava border 516, atrioventricular valve border 518, aortic border 520, and superior border 522. The vascular device 200 can produce a user-defined, adjustable atrial septostomy by means of a retractable cutting tool, combined with suture-mediated closure resulting from the atrial septostomy.

[0106] After the septal puncturator punctures the atrial septum 300 at the ideal location, the distal end of the vascular device 200 can be inserted into the tissue plane. An initial incision 502 or 506 can be formed in the atrial septal wall and then extended to a specific desired amount 504 or 508 to allow for the use of therapeutic instruments. Furthermore, positional control and visualization allow the user to avoid unwanted anatomical structures 524, such as the aortic margin 520 or superior margin 522, or to perform external atrial perforation, or to cut through the myocardium.

[0107] The target of tissue incision 502 or 506 may be a location on the interatrial septum 300 such that it allows access to the desired treatment target, such as the mitral valve. In one instance, the incision length or size may be configured to accommodate the surgical device or apparatus without further damaging the tissue plane. When the tissue is cut to a specific length large enough, it will not tear beyond the required incision length. This can be achieved by matching the periphery of incision 502 or 506 and the desired amount 504 or 508 to the periphery of the treatment device. In one embodiment, creating an incision slightly larger than the subsequent treatment catheter can provide the user with more flexibility. In typical septal punctures, if the initial puncture location is inappropriate, the user may need to withdraw the catheter, re-puncture, and re-dilate, with the risk of tissue tearing.

[0108] This length can also be adjusted to accommodate stretching of the tissue plane. The tissue margins around the atrioventricular fossa can be used as a reference for incisions 502 or 506 that initiate or limit tissue movement. Extending incisions 502 or 506 beyond or outward from the edge of the fossa may require more force or energy to generate and thus serve as a feedback loop to determine the location of incisions 502 or 506.

[0109] In one example shown below, the vascular device 200 may have a cutting arm and a central puncture member. This configuration allows the operator to rotate the tool to create a slit in the desired direction. The edge of the fossa of the heart 108 can be used as a starting point, as this point may be easier to puncture first, and then the cutting member can be rotated to cut along the selected direction. Alternatively, two symmetrical cutting arms extending from the center (with or without a central puncture face) can be used. This configuration allows the physician to puncture at a known height or location, which allows them to determine where the center of the incision can be located, as the incision is symmetrical.

[0110] Turning to FIG. 6, which discloses a first embodiment, an illustrative side view of an exemplary vascular device 200 according to one aspect of the invention is provided. The vascular device 200 may have a distal region extending from the body of the device 200, which may be a tip or an anchor. The length of the sheath 606 extends the body to a sheath hub 608. The tube 606 may be substantially curved near its distal end to provide deflection of the catheter in a direction approximately 180 degrees to the exit path of the guidewire 102. As shown, the sheath hub 608 may be a three-port hub 608. In other embodiments, the hub 608 may be configured with fewer or more ports. Multiple devices may be inserted into and retracted from the hub 608, as will be shown below.

[0111] In summary, the vascular device 200 can be used to place sutures in the atrial septum before or after a controlled atrial septalostomy performed via a device placed in hub 608. Other medical devices can be accessed and positioned in the left atrium and have the ability to subsequently close the ASD. Advantageously, the manner in which the ASD is closed allows for future passage through tissue if subsequent catheter-based procedures are required.

[0112] Turning to Figure 7, an axonometric view of the distal end of an exemplary vascular device 200 in a low-profile configuration according to one aspect of the invention is provided. Device 200 may allow placement of an atrial septostomy closure suture, i.e., a blade-type atrial septostomy, prior to the introduction of a cutting tool. The entire device 200 can be run on a guidewire that passes through the right atrium and is positioned on the atrial septum.

[0113] The vascular device 200 described herein can facilitate the creation of a controllable and / or adjustable access incision in a tissue plane (such as the atrial septum), thereby allowing for easy, controlled closure of the incision after the procedure. This closure can be customized to be hemodynamically sealed or, conversely, to allow a certain amount of flow. For example, the therapeutic device can be used to perform diagnostic and therapeutic interventions to correct atrial fibrillation, perform mitral valve repair, correct septal defects, or perform cardiac prosthesis implantation.

[0114] The distal vascular device 200 may include a catheter shaft 702 or body, an anchor 704, and a guidewire lumen 706. These components may be made of, for example, polymeric materials. Elastic materials may be used to construct the catheter shaft 702 to maximize flexibility. These materials may be used to construct the inner and outer walls of the shaft 702. The reinforcing structure within the device 200 may be made of metal, such as stainless steel, titanium, etc. In this embodiment, the reinforcing structure is ductile but retains sufficient strength to overcome any forces applied to it.

[0115] The catheter shaft 702 or delivery catheter may have a tubular body. In one embodiment, the shaft 702 may have a circular cross-section for receiving components. These components may extend proximally to the vascular device 200. The left atrial appendage implant described below may radially contract during delivery via the shaft 702. In one embodiment, the implant may be delivered via a catheter of 14 French or larger with a radially expandable delivery sheath.

[0116] Referring again to FIG7, the anchor 704 of the vascular device 200 can be delivered to the interatrial septum and can extend from the catheter shaft 702. The anchor 704 and the catheter shaft 702 may include components that perform a specific function enabling the passage of a tissue delivery suture from a remote location. For the purposes of this embodiment, the anchor 704 may be tapered. Alternatively, the anchor 704 may have a funnel-shaped, circular, pointed, or apex-shaped shape, but is not limited thereto. The anchor 704 may have a bevel that conforms to the interatrial septum.

[0117] The guidewire lumen 706 can travel within the catheter shaft 702 and anchor 704 of the vascular device 200. Lumen 706 allows the vascular device 200 to be advanced and delivered over a previously placed guidewire. The previously described guidewire can be inserted into the patient via the femoral vein, ascending into the inferior vena cava and into the right atrium. A septal puncturist for placing the initial perforation can be located within the guidewire and is removable from it.

[0118] Figure 8 is an axonometric view of the distal end of an exemplary vascular device 200 viewed from different angles according to one aspect of the invention, wherein a portion of the device 200 is advanced, showing components for puncturing tissue and passing through sutures. An anchor 704 having a tapered shape can be advanced from the tip of a catheter shaft 702 within the patient's heart. The distance the anchor 704 is advanced can depend on the thickness of the tissue it traverses and the size of the chamber it enters.

[0119] The vascular device 200 can be designed to allow or limit the amount of variation in the movement of the anchor 704. This travel can be as small as a few millimeters or as large as a few centimeters. For the purposes of this invention, it is assumed that the anchor 704 can pass from the right atrium through the interatrial septum into the left atrium, and that the catheter shaft 702 can be held on the right side of the heart within the right atrium. The anchor 704 can be extended such that the needle 804 of the anchor 704 allows it to hook or grip within the left atrium 304.

[0120] Once the anchor 704 is advanced, the needles 804 can be exposed. In one embodiment, as shown, four needles 804 can be removably attached to the anchor 704. The needles 804 can face rearward. For example, when the anchor 704 has been extended into the left atrium, the needles 804 can extend toward the catheter shaft 702 or body of the vascular device 200. The faces of the catheter shaft 702 and the anchor 704 can be at a prescribed angle to allow for more orthogonal contact with the tissue, which will promote a more stable interface between the tissue and the catheter shaft 702.

[0121] The advance shaft 802 of the anchor 704 for the vascular device 200 may be rectangular and passes through a corresponding rectangular cavity within the catheter shaft 702 to maintain precise rotational alignment with the catheter shaft 702. Typically, the alignment between the anchor 704 and the catheter shaft 702 is maintained because it allows the device to function. The advance shaft 802 may extend and retract proximally from the vascular device 200, as shown above, which may be located at the percutaneous puncture site or incision site.

[0122] Referring to FIG9, an axonometric view of the distal end of an exemplary vascular device 200 according to one aspect of the invention is provided, wherein a portion of the device 200 is advanced through tissue 900 in the interatrial septum. The vascular device 200 has passed through a representative portion of the tissue 900. An anchor 704 having a tapered shape has been advanced through a puncture site in the tissue 900, which was previously performed by a septal puncturist. The catheter shaft 702 may be larger than the perforation created by the septal puncturist, thereby preventing the catheter shaft 702 from entering the tissue 900. This allows tissue to be tightly or securely fixed around the narrow aspect of the device.

[0123] Figure 10 is a cross-sectional view of an exemplary vascular device 200 according to one aspect of the invention, having an exemplary lumen configuration. The catheter shaft 702 may include several channels or lumens to allow certain components to pass through it. As an example, four lumens 1002 of equal diameter may allow a snare to grasp, hook, or loop needles removably connected to anchors via tethered sutures to pass through them. A central rectangular channel 1004 may allow the rectangular advance shaft of the anchor to pass through it. This configuration can keep four needles and cutting tools aligned within the catheter shaft 702, which will be shown later.

[0124] Depending on the placement of the sutures, different configurations of the cross-section of the vascular device 200 can be achieved. For example, more than four lumens 1002, each equidistant from the center, can be guided via the catheter shaft 702. Advantageously, the lumens 1002 can provide adequate spacing for initial puncture, thereby enabling suture management. The perforations for capturing the needle into the lumens 1002 can be configured to avoid unnecessary tearing of the tissue while still allowing for proper suture placement. The illustrated configuration allows for two sutures with four needles, but other configurations are also possible and within the scope of this invention. In one embodiment, the holes can be radially surrounding the central lumen, through which the user can selectively advance any number of needles / sutures. The sutures can be loaded proximally in any configuration of user choice.

[0125] Figure 11 is an axonometric sectional view of the distal end of an exemplary vascular device 200 according to one aspect of the invention, showing the internal geometry of the components therein. For illustrative purposes, a portion of the anchor 704 has been removed, thereby allowing observation of the bundled sutures 1102 loaded in the recessed channel 1104 of the tapered anchor 704.

[0126] The ends of the suture bundles 1102 can be connected to two needles 804 at opposite ends. As shown, the two suture bundles 1102 can have four needles 804. The sutures 1104 can be placed on opposite sides drawn or separated by the advance shaft. The needles 804 on both sides can simultaneously engage with the recessed channel 1104 to untie the two suture bundles 1102. When the needles 804 are pulled into the guide shaft 702, the recessed channel 1104 can rotate for the two different bundles of sutures 1102.

[0127] The recessed channel 1104 can be shaped to allow the unwinding and release of the suture bundle 1102. In one embodiment, the thread of the suture bundle 1102 can be wound into the recessed channel 1104, which can be held taut within the anchor 704. When a needle attached to the suture bundle 1102 is pulled, the suture bundle 1102 can be unwound. After the suture bundle 1102 has been pulled a predetermined amount by the needle 804 into the guide shaft 702, the suture of the suture bundle 1102 can be released from the anchor 704. This amount can be, for example, a few centimeters.

[0128] Referring to Figure 12, an isometric view of the distal end of an exemplary vascular device 200 according to one aspect of the invention is provided, showing a snare 1202 advanced beyond the body of the vascular device 200. Four snares 1202 are available for gripping, hooking, or looping suture bundles, each suture bundle having a needle 804 at its opposite end for snare application. Small punctures can be made to allow the snare 1202 to pass through tissue, or the snare 1202 itself may have a tip capable of puncturing tissue. The snare 1202 may be positioned proximally through a catheter shaft 702 and outside the aforementioned lumen. Once the needle 804 is engaged, the snare 1202 can be retracted through the catheter shaft 702.

[0129] In one example, the snare 1202 may use a groove 1204 placed within the needle 804. These grooves 1204 may be tilted and aligned with the anchor 704 of the vascular device 200. When the snare 1202 is pushed through the catheter shaft 702, the hook of the snare 1202 may be pulled and secured to the groove 1204.

[0130] A mechanism can be used at the proximal end of the catheter shaft 702 to simultaneously push multiple snares 1202 through. The snares 1202 can grasp needles 804 and then simultaneously pull needles 804 through the tissue. In an alternative embodiment, the snares 1202 can be pushed individually into the shaft 702 to capture or hook a single needle 804 at a time through their recesses 1204. In one embodiment, two snares 1202 can operate one after the other to pull two corresponding needles 804 through the shaft 702. The two needles 804 can be attached to opposite sides of a suture bundle. The needles 804 can be trimmed from the suture after being pulled into the shaft 702.

[0131] The snare 1202 can be made from a variety of materials. For example, the snare 1202 can be made from a radiopaque platinum coil and tip to enhance visibility. The snare 1202 may include a spiral ring design for a smaller profile but a longer range than a right-angle ring. A durable cobalt-chromium ring can increase strength and maintain its shape. The snare 1202 can be available with rings of different sizes: ring diameters of 1 mm, 2 mm, and 3 mm, for clinical versatility.

[0132] Figure 13 is an axonometric view of the distal end of an exemplary vascular device 200 after four suture needles 804 and the suture ends have passed through tissue 900, hooked and pulled through the length of the device 200, according to one aspect of the invention. The catheter shaft 702 of the vascular device 200 can receive needles 804 after they have been pulled by a snare. The suture 1302 can be unwound and tensioned from the recessed channel by the tension of the needles 804 connected to opposite ends.

[0133] In one embodiment, the suture 1302 may be made of finely braided nylon material. Other materials may be used, such as, but not limited to, polypropylene, silk, or polyester. The suture 1302 may be made of a strong but flexible material. The suture 1302 may be U-shaped or C-shaped. The suture 1302 may be immediately soaked in sterile mineral oil before use. The edges of the suture 1302 may be easily sutured to the edges of the interatrial septum incision. The suture may be made of a heat-resistant material to prevent damage upon contact with cutting tools.

[0134] Figure 14 is an axonometric view of the distal end of an exemplary vascular device 200 according to one aspect of the invention, after the suture 1302 has been fully pulled through the length of the device 200 and is now taut against the tissue. The suture 1302 can be completely untied from the groove of the anchor 704. The end of the suture 1302 can be provided to the user through the proximal end of the catheter shaft 702 of the vascular device 200. In operation, the suture can be loosened or tightened at specific times as needed by the user.

[0135] Referring now to FIG15, an axonometric view of the distal end of the vascular device 200 after the cutting tool 1500 has been partially advanced to expose the cutting element 1506, according to one aspect of the invention, is provided. Once the sutures 1302 are pulled toward the tissue so that they are not cut, the tapered anchor 704 can be further advanced into the left atrium via the advance shaft 802. The shaft 802 extends through the catheter shaft 702 of the vascular device 200 toward and through a perforation in the interatrial septum. The advance shaft 802 can extend through the proximal end of the vascular device 200.

[0136] The second rectangular telescopic cutting tool 1500 can deliver a rectangular channel through the catheter shaft 702 by passing through the tissue of the interatrial septum via the propulsion shaft 802. The cutting tool 1500 may include a dilation actuation shaft 1502 that can extend and retract on the propulsion shaft 802 for the anchor 704. That is, the dilation actuation shaft 1502 can slide on the propulsion shaft 802 of the anchor 704.

[0137] The dilation actuation shaft 1502 can be advanced through a perforation and located within the left atrium, extending the cutting tool 1500. As the dilation actuation shaft 1502 is pushed forward, the cutting tool 1500, which has a linkage system 1504, is exposed. The distal end of the cutting tool 1500 can be temporarily locked to the top of the advance shaft 802 of the anchor 704, while the proximal end of the cutting tool 1500 can be connected to the lower part of the dilation actuation shaft 1502.

[0138] When the anchor 704 is retracted and the expansion actuation shaft 1502 is held in place, the linkage system 1504 can bend outwards and expand the cutting element 1506 to a length much larger than the diameter of the vascular device 200. When the advance shaft 802 is retracted, the linkage system 1504 can bend at the point of symmetry 1508. As shown, the cutting element 1506 is positioned behind the anchor 704, thus facing the catheter shaft 702. In operation, when the cutting element 1506 expands, the linkage system 1504 eliminates any possibility of cutting the suture 1302 parallel to it.

[0139] Figure 16 is an isometric view of the distal end of the vascular device 200 when the cutting tool 1500 is dilated according to one aspect of the invention. In one configuration, the anchor 704 is retracted, covering the advance shaft. When this is implemented, the top of the cutting tool 1500 is held and lowered by the anchor 704, and the dilation actuation shaft 1502 holds the bottom of the cutting tool 1500 in place. This may cause the cutting tool 1500 within the linkage system 1504 to bend and expose the cutting element 1506. The cutting element 1506 may be perpendicular to the shaft, such that the cutting element 1506 dilates beyond the diameter of the catheter shaft 702.

[0140] The cutting element 1506 can be aligned parallel to the suture 1302, preventing it from unintentionally cutting the suture 1302. Multiple incisions or nicks can be created by cutting the tissue and pulling the cutting element 1506 back into the left atrium. These processes can be repeated depending on the desired number of incisions. Therefore, the number and position of sutures / needles can vary depending on the size and number of incisions.

[0141] Upon completion, the cutting element 1506 can be retracted by advancing the anchor 704. The linkage system 1504 can be retracted by this advancement, and the system 1504 can be compressed into a narrow channel without exposing the cutting element 1506. The lock connecting the top of the advancing shaft and the cutting tool 1500 can be removed. The cutting tool 1500 can then be pulled through the catheter shaft 702 without moving the anchor 704. After removing the cutting tool 1500, the vascular device can be removed, leaving the suture 1302 in place.

[0142] Other techniques or devices can be used to expand and contract the cutting element 1506 so that tissue is not unintentionally cut when the anchor 704 of the vascular device 200 is used in the left atrium. The connection system 1504 allowing the use of the cutting element 1506 can take many forms and is not limited to the form shown in this embodiment. For example, the linkage system 1504 can be entirely located on the expansion actuation shaft 1502, whereby a mechanism at the proximal end can be used to expand and contract the cutting element 1506 without retracting the anchor 704. The cutting element 1506 can be expanded and contracted using a separate knob, pull wire, etc. Other variations are possible and are within the scope of this invention.

[0143] Referring now to FIG17, an isometric view of an exemplary vascular device 200 positioned to cut tissue 900 according to one aspect of the invention is provided. The vascular device 200 can be tilted at a predetermined angle to allow for more orthogonal contact with the tissue 900. This promotes a more stable interface between the tissue 900 and the catheter axis 702.

[0144] The distal end of the catheter shaft 702 can be angled to conform to the tissue 900. The shaft 702 typically does not pass through the initial perforation or slit 1702 created by the cutting element 1506. However, the anchor 704 of the vascular device 200 can extend through the perforation and into the left atrium. The linkage system 1504 can be deployed, and the cutting element 1506, which can be in the form of a blade, can be used to cut the slit 1702 through the tissue 900. The length of the slit 1702 can be controlled by the degree of extension of the linkage system 1504. The vascular device 200 can be rotated to create additional slits 1702 or combinations of slits 1702.

[0145] During the procedure, the anchor 704 of the vascular device 200 can be advanced through the initial puncture. The needle can then extend toward the catheter axis 702. A suture can then be laid from the rear end toward the tissue 900 before any incision 1702 is formed. The suture can then be managed after the incision 1702 and the treatment device have been used.

[0146] Figure 18 is an axonometric view of a suture 1302 inserted into tissue 900 according to one aspect of the invention. Two sutures 1302 may correspond to those sutures untied from the recess of the anchor. After removal of the vascular device, the two suture segments 1302 may be retained in the appropriate position behind the atrial wall extending from the left atrium.

[0147] Furthermore, the guidewire previously used by the vascular device can remain in place. This guidewire can be used with a larger-diameter device, such as a therapeutic device, which can now travel over the guidewire and easily enter the left atrium through the incision, proceeding near the previously placed suture. Once the large-diameter device is removed, the free end of suture 1302 can be knotted and pushed into the tissue to create a closing force. This reduces the size of the incision or hole in the tissue used by the large-diameter device. Advantageously, this prevents or minimizes hemodynamic communication between chambers and allows the user to leave a simple knot in the atrial septum. Typically, this hole may close in the short term. In the long term, this can be used to allow subsequent access to the left atrium if the patient requires another catheter-based procedure or intervention.

[0148] Figure 19 is an axonometric view of an incision after tissue 900 has been joined with suture 1302, according to one aspect of the invention. A close-up view of tissue 900 is provided after knot 1902. The slit created by the cutting tool has been tightened in the middle by knot 1902, which can reduce or eliminate hemodynamic flow and communication between chambers. For illustrative purposes, knot 1902 can be represented by a simple “X” construction. Alternatively, knot 1902 can be one of several different types of surgical knots that can be tied and pushed down into vascular devices at remote locations.

[0149] In one embodiment, knot 1902 can be formed and advanced using a knot pusher having a pusher equipped with a distal port and a cutting member in the form of a sharp outer sheath. Knot 1902 can hold the associated patch in place, where excess wire can be trimmed by the shearing action of the distal port of the pusher and the distal sharp portion of the cutting member. Excess wire and other elements can be removed from the conduit.

[0150] Knot pushers known in the art include the Edwards ThruPort knot pusher; the Medline endoscopic knot pusher; and the Cooper Surgical laparoscopic knot pusher.

[0151] Arthrex offers several options: The Single-Hole Knot Pusher provides a simple way to advance slip knots and half knots. This closed-end knot pusher has an improved handle that provides an ergonomic feel. The distal end has also been modified for easier advancement of slip knots and half knots. A sixth finger is designed to tie the surgeon's knot and allows the surgeon to apply and maintain tension on the first throw while advancing subsequent throws. The CrabClaw features open jaws that allow for intra-articular suturing.

[0152] A simple closure incision has been described previously. Turning to Figures 20A-L, various exemplary cutting patterns can be formed using vascular devices in the interatrial septum according to one aspect of the invention. These cutting patterns can be made by at least one rotatable cutting tool that can be used once or multiple times. These embodiments can form various cutting shapes in the interatrial septum. These shapes can be produced using multiple cutting arms, or using a single rotating and reusable cutting arm, such as the cutting tool shown above. The length of the incision can be controlled by the user by activating an adjustable cutting tool. The incision can take on a variety of different geometries, generally used to facilitate the passage of therapeutic devices and the closure of the tissue plane after treatment.

[0153] Referring to Figures 20A-20C, the juxtaposition of tissue edges can be controlled by the positional properties of anchors or sutures 2002 and 2004. To increase overlap or tissue juxtaposition, the first distance 2006 between sutures 2002 and 2004 can be increased to a second distance 2010. Another method or technique could be to add additional suture locations or sutures 2012 at various intersections. The incision 2008 can be located in the middle of sutures 2002, 2004, and 2012.

[0154] Incision 2008 can take various forms, such as a straight incision, a V-shaped incision 2020, a serrated incision 2022, or a crescent-shaped arc incision 2024, to name just a few examples, as shown in Figures 20D-F. These incisions can then be combined with other shapes to create multiple tissue flaps 2030, 2032, or 2034, as shown in Figures 20J-L. Various configurations may be advantageous depending on the shape and size of the device to be passed through and / or the type or number of closures required. Due to the shape of the incision and the tension of the tissue before and during healing, some incision shapes, such as those in Figures 20D-F, can promote tissue plane overlap 2026 upon closure. This overlap can greatly contribute to the healing of tissue edges. That is, in Figures 20G-I, tissue plane overlap 2026 from different incision shapes 2020, 2022, and 2024 is shown.

[0155] The embodiments described herein manage variables to control the closure of incision 2008. Tissue edges can be managed by placing control components in place before incision 2008 is formed. For example, as shown above, placing sutures 2002, 2004, and 2012 in place before the cutting tool forms incision 2008 can secure the tissue. In one embodiment, control features can be applied after incision 2008 is formed.

[0156] The position of tissue edges and their juxtaposition relative to each other can be controlled to manage the amount of tissue overlap, juxtaposition pressure, and residual flow after closure application. This control can be achieved by controlling the position of the suture relative to the incision. An example of this is that the farther the suture is from the incision edge, the more tissue bundles and / or tissue overlap may result. Increasing the number of tissue anchors and / or suture passage positions can increase the amount of tissue attachment along the length of the incision. The amount of tension or pressure applied to the suture tension line can further affect the amount of closure on the incision. These mechanisms can be managed in real time and monitored under echo flow monitoring and / or fluorescence fluoroscopy visualization.

[0157] In one embodiment, a device that does not leave a long-term implant in the patient can be used. The device can be designed to close the tissue, allowing it to heal in a closed state or in a partially closed state. The percentage of hemostasis can be adjusted by changing the application of this mechanism. The device can be designed to immobilize the tissue at different time points. These time points can be correlated with various tissue healing cascades, such as the time of tissue coagulation, adhesion, endothelialization, and scarring.

[0158] An absorbable material may be left behind, which will aid in closure and be absorbed by the body over time. In one embodiment, the absorbable material may be removed from the body at a later point in time. Before incision 2008 is formed, the closure may be fully or partially engaged in the tissue plane near incision 2008. In another embodiment, after incision 2008 is formed, a closure may be applied in the vicinity of incision 2008, fully or partially engaged in the tissue plane. In one embodiment, after incision 2008 and the treatment device are removed from incision 2008, the closure mechanism may be fully or partially engaged in the tissue plane near incision 2008.

[0159] The cutting tools described herein can be used to control the condition of tissue edges based on the method of creating an incision in the tissue. Methods for creating an incision may include, but are not limited to, sharp blades made of durable materials such as metal or ceramic, electrocautery, radiofrequency energy, plasma jet vaporization, ultrasound, high-pressure vaporization, controlled expansion, heating, and cooling. Using these different incision-creating methods, the cellular state at the edge of the cut surface can be controlled to optimize the desired healing cascade.

[0160] Figure 21 is an isometric view of an exemplary cutting pattern 2106 for making an incision to facilitate tissue edge attachment according to one aspect of the invention. The cutting pattern 2106 may be defined by a first end 2102 and a second end 2104. The cutting pattern 2106 may be made in tissue 900. The inner edge 2108 is separated from the outer edge 2110. This can be a combination of straight lines and arcs for the incision to facilitate tissue edge overlap and juxtaposition.

[0161] Figure 22 is an isometric view of an exemplary cutting pattern for promoting tissue edge juxtaposition under slight tension, according to one aspect of the invention, illustrating tissue edge control and edge overlap when tension is applied. This shows the overlap of the inner edge 2108 and the outer edge 2110, wherein the yield overlap 2202 in the tissue 900 is caused by the cutting pattern between the first end 2102 and the second end 2104.

[0162] Figure 23 is an isometric view of a cutting pattern for promoting tissue edge juxtaposition according to one aspect of the invention and a helical anchor 2300 for controlling tissue edges. Tension can be applied in the directions of the ends 2102 and 2104 of the cut. The inner edge 2108 and outer edge 2110 of the tissue 900 having a yield overlap 2202 can be fixed with the helical anchor 2300 or the like.

[0163] Previously, a first embodiment of the vascular device was described. Figures 24-38 depict a second embodiment of the vascular device 2400 with additional exemplary incisions. It will be understood from the present invention that components of these embodiments can be interchanged, added, or removed based on reasonable configuration. New embodiments using these modifications are within the scope of the present invention.

[0164] Turning to Figure 24, an isometric view of an exemplary expandable RF cutting tool 2410 having four expandable members 2416 is provided according to one aspect of the invention. As previously stated, the cutting tool 2410 can be located between the conduit shaft and the distal anchor. Although four cutting members 2414 are shown, fewer or more cutting members can be used, each cutting member 2412 being equidistant from each other.

[0165] The cutting tool 2410 can expand and contract via a similar linkage system as described above. The cutting tool 2410 can contract upon initial puncture and expand after passing through tissue. The cutting tool 2410 may have four expandable members 2414 connected to four cutting members 2412. The cutting members 2412 may be positioned at the proximal end of the cutting tool 2410 such that the cutting tool is pulled toward the tissue for cutting.

[0166] The cutting member 2412 can extend radially from the center of the cutting tool 2410. The width of the cutting member can vary to change the incision length based on the French dimensions of the delivery catheter. The cutting tool 2410 may also include a tip puncture device 2416 located at the distal end of the cutting tool 2410. This can be used to puncture tissue. The cutting member 2412 and the tip puncture device 2416 can use mechanical energy or electrical energy. The mechanical or electrical energy can be derived from at least one of blade, ceramic, electrocautery, RF, plasma jet vaporization, ultrasound, high-pressure vaporization, controlled expansion, heat, and cold. In one example, both the cutting member 2412 and the tip puncture device 2416 can use mechanical energy. Alternatively, they can use two types of electrical energy. In yet another variation, the cutting member 2412 and the tip puncture device 2416 can use different types of energy. The cutting tool 2410, together with its member 2412 and arm, can expand radially in a controlled manner or planar manner, such that they minimize or prevent the possibility that the cutting tool 2410 may inadvertently cut or negatively affect previously placed closure sutures.

[0167] Figure 25 is an isometric view of an exemplary vascular device 2400 according to one aspect of the present invention, the vascular device 2400 having an expandable cutting tool 2410 having a tip for puncturing tissue 900. A tip puncture device 2416 may be connected to the cutting tool 2410 and may be pushed through the tissue 900 to create a puncture within the tissue 900. The puncture may be performed via a mechanism on the proximal end, allowing a physician to control the vascular device 2400. The cutting tool 2410 may be in a retracted state before being advanced through the tissue 900.

[0168] The catheter shaft 2504 or delivery catheter may accommodate, but is not limited to, the cutting tool 2410 and the anchoring mechanism 2502. The anchoring mechanism 2502 may be equidistant from the center of the catheter shaft 2504. Although four anchoring mechanisms 2502 are shown, fewer or more anchoring mechanisms may exist depending on the closure strategy of the incision formed in the tissue 900.

[0169] Although not shown, the vascular device 2400 may include visualization tools for determining the location of the device 2400 within a patient's body. In one embodiment, sensors may be attached to the device 2400 to determine the location and orientation of a catheter. Optionally and / or additionally, a separate tracking system may be based on ultrasound, impedance, or fluoroscopy tracking. In the case of impedance, the potential generated by an electric field generator can be detected by existing electrodes. In the case of fluoroscopy, electrode positions can be detected through image processing that identifies and tracks electrodes and / or opaque markers located on the device 2400.

[0170] Figure 26 is an isometric view of an exemplary vascular device 2400 according to one aspect of the present invention, wherein an exemplary expandable cutting tool 2410 is positioned outside tissue 900. After puncture of tissue 900, the cutting tool 2410, in a retracted state, can be extended. The cutting tool 2410 can be delivered via a propulsion shaft that can be controlled proximally, while the catheter shaft 2504 is not distributed therethrough.

[0171] After the cutting tool 2410 has been inserted into the left atrium, the cutting tool 2410 can expand. The expandable member 2414 can extend radially from its center, and its diameter can be expanded to be larger than the diameter of the device 2400 itself.

[0172] An anchoring mechanism 2502 within the conduit shaft 2504 can be used to actuate the delivery mechanism, as will be described below. The anchoring mechanism 2502 may be distributed within the conduit shaft 2504 and closed within the cavity. The anchoring mechanism 2502 may surround the centralized cutting tool 2410 and be equidistant from each other.

[0173] Referring to Figure 27, an isometric view of an exemplary vascular device 2400 according to one aspect of the invention is provided, wherein an exemplary expandable cutting tool 2410 forms incisions in tissue 900. After the expandable member 2414 extends, the advance shaft can be pulled back toward the catheter shaft 2504 together with the tip puncture device 2416 to form incisions in tissue 900. These incisions can be formed on the backplane of the left atrium. The cutting tool 2410 can extend, rotate, and then retract to form additional incisions in tissue 900. During this time, the anchoring mechanism 2502 can remain stationary.

[0174] Figure 28 is an isometric view of an exemplary vascular device 2400 according to one aspect of the present invention, wherein an exemplary expandable cutting tool 2410 advances an anchor delivery mechanism 2502. When the anchor mechanism 2502 is pushed through the catheter shaft 2504, it can extend through tissue 900 to the other side, i.e., the left atrium. The anchor mechanism 2502 may be connected to a delivery mechanism 2802 that can be transferred through tissue 900. The delivery mechanism 2802 may have a tissue puncture point.

[0175] Four delivery mechanisms 2802, connected to four anchor mechanisms 2502, can puncture tissue 900. Fewer or more combinations of structures may exist within the vascular device 2400. The delivery mechanisms 2802 can use energy similar to that of the expandable member 2414 and the tip puncture device 2416. That is, a combination of mechanical and / or electrical energy can be used.

[0176] Figure 29 is an isometric view of an exemplary vascular device 2400 according to one aspect of the invention, the vascular device 2400 having an exemplary expandable cutting tool 2410 having a further inserted advance anchor 2902 to advance an anchor mechanism 2502. The anchor mechanism 2502 can advance a delivery mechanism 2802 within a catheter shaft 2504 into and beyond tissue 900, i.e., into the left atrium. Thereafter, the advance anchor 2902 can be deployed by the delivery mechanism 2802. The advance anchor 2902 can be used to secure tissue 900 and its surrounding area. The anchor 2902 can be made of PLGA, PLLA, nylon, polyester, PEEK, or other biocompatible materials. It should be noted that after the advance anchor 2902 is in place, the cutting tool 2410 can be advanced into tissue 900.

[0177] Other anchors can be used to secure tissue 900. For example, tissue anchors can be used. These can include, but are not limited to, sutures, elbows, spiral structures, grasping devices, flip clips, expansion structures, mesh structures, scaffold structures, patch structures, clamps, expandable valves, and suture structures.

[0178] Figure 30 is an isometric view of an exemplary vascular device 2400 with the delivery mechanism 2802 removed according to one aspect of the invention. An anchor mechanism 2502, connected to the delivery mechanism 2802, can be pulled at the proximal end of the catheter shaft 2504. This allows the delivery mechanism 2802 to retract from the left atrium 302 back into the right atrium 106. A cutting tool 2410 with an expandable member 2414 and a tip puncture device 2416 can still be inserted into the patient's left atrium. Anchors 2902 can abut against tissue 900. These can be embedded therein.

[0179] Figure 31 is an isometric view of an exemplary cutting tool 2410 according to one aspect of the invention, which is removed from tissue 900, leaving a tissue anchor 2902 abutting thereon. The cutting tool 2410 can be removed via the catheter shaft 2504 of the vascular device 2400. At this time, the catheter shaft 2504 can still be placed in the patient's right atrium.

[0180] Referring to FIG32, an isometric view of an exemplary elbow 3202 within tissue 900 according to one aspect of the invention is provided. Elbow 3202 can be longitudinally pushed or advanced through tissue into the left atrium from the right atrium. Elbow 3202 can be horizontally moved and secured to the septal wall to hold the tissue in place. Elbow 3202 can be made of a material similar to an anchor, which can be biodegradable. The size and location of this closure device, or other closure devices disclosed herein, do not preclude further access in the future.

[0181] Several cutting tools are described in advance. These tools, as well as those described below, can use mechanical or radio frequency energy. When using electrical energy, insulation minimizes the amount of exposed metal, ensuring that the exposed metal exists only in the desired tissue cutting area of ​​the tool. The less exposed metal, the better the cutting effect on the tissue. Advantageously, this allows the use of less power. To achieve optimal cutting results, the operator can ensure good mechanical contact between the cutting area and the target tissue.

[0182] The initial puncture site and the puncture can be performed using separately applied energy. For example, using electrical energy, a first circuit can be used to perform the first puncture, and a second circuit can be used to achieve a larger cut. If the first puncture is performed separately from the cut, the operator can rotate the cutting tool to align the cutting arm in the direction they want to cut. If a second cut is performed after the initial puncture by advancing the cutting tool from the right atrium to the left atrium, it may be beneficial to overlap the cutting area of ​​the initial puncture with the second, larger cut, so that no piece of tissue is left uncut.

[0183] If the tool has symmetrical cutting arms on either side of the central puncture element, the center of the entire incision can be located at the intended puncture position without shifting in one direction. This is important for the success of subsequent surgical steps that may require a distance above the target structure.

[0184] The following cutting tools can create a continuous cut from the center puncture site to the edge of the incision. The purpose of these tools is to cut from the center all the way to the edge. Adjustability or expandability of the cutting tool can be achieved using a drawstring / loop mechanism, allowing the cutting tool to be compressed and bent outwards with the drawstring, as described above. Alternatively, a spring or a forming tool made of shape memory alloy can be used.

[0185] Turning now to Figure 33, an isometric view of an exemplary cutting tool 3300 according to one aspect of the invention is provided, the cutting tool 3300 having a damage-resistant tip 3304 extending from an exemplary vascular device. The cutting tool 3300 can be deployed from the distal end of a tubular member 3302, wherein electrical insulation is selectively removed. The dimensions of the cutting tool 3300 may be fixed or adjustable through mechanical design.

[0186] This design can be combined with an atraumatic tip 3304, which can be used to locate the fossa ovalis or other desired target locations. It also features a cutting surface 3306 that can extend symmetrically to both sides of the atraumatic tip 3304. In these types of embodiments, the initial slit puncture and slit generation can be performed in one action using the same continuous cutting surface 3306; that is, they can be part of the same circuit for energy delivery, and they can also be on separate circuits. If the puncture / cutting energy is RF, microwave, or other electrical energy, insulation can be strategically removed from the metallic structure. The amount of insulation removed or the amount of metal exposed can be varied to optimize performance. For example, it can be completely around the cutting arm, or it can exist as a narrow line along the length of the cutting surface arm. The goal can be to ensure that the cutting surface is energized and in good contact with the tissue, with minimal direct communication with the blood pool.

[0187] Figure 34 is an isometric view of an exemplary cutting tool 3400 having a slit 3404 within a sheath 3402 extending from an exemplary vascular device according to one aspect of the invention. The cutting tool, comprising a cutting arm, can be radially expanded through the slit 3404 in the needle-like sheath 3402, as will be shown below. In this embodiment, only one cutting arm is used, the size of which can be fixed or adjusted by a mechanism, such as using a drawstring, spring, etc. The distal portion 3406 of the cutting tool 3400 can be used for initial puncture. Unlike the embodiments described above, if electrical energy is used for cutting tissue, the initial slit puncture site and slit formation are part of independent parallel circuits.

[0188] Figure 35 is a side view of an exemplary cutting tool 3400 according to one aspect of the invention, the cutting tool 3400 having a cutting element 3502 extending from a slit 3404 in a sheath 3402. An expandable cutting arm 3504 is part of a traction line that can extend the length of a catheter, while the puncture needle face is another part.

[0189] In one embodiment, the initial puncture needle may be completely insulated, with only the distal region having exposed metal for delivering energy to the tissue. The expandable cutting element 3502, in the form of a radially extending arm, may have circumferentially exposed metal, or be largely insulated from exposed metal wires extending along the cutting surface (or any number of patterns for exposing a minimal metal surface area). These two distinct cutting surfaces can be simultaneously energized by a single switch or by different switches at the handle end, allowing energy to be applied at different times during the procedure, which is both possible and desirable. The advantage of initial puncture with only a needle is that it creates an anchor point in the tissue. Once this initial puncture is complete, the operator can rotate the cutting tool 3400 until the expandable cutting element 3502 is aligned with the desired cut length.

[0190] Figure 36 is an isometric view of the distal end of an exemplary cutting tool 3400 according to one aspect of the invention. An expandable cutting arm 3504 for the cutting element 3502 may be a line extending along the length of the conduit. A puncture needle 3602 may be part of another mechanism to be actuated. The cutting element 3502 may have circumferentially exposed metal, or be insulated with a thin exposed metal wire extending substantially along the cutting surface. In operation, the expandable cutting arm 3504 can be pushed up and down to change the shape of the cutting element 3502.

[0191] The initial puncture needle 3602 can be completely insulated, with only the distal region having exposed metal for delivering energy to the tissue. In one embodiment, the cutting tool 3400 may have two distinct cutting surfaces, simultaneously energized by a single switch or by different switches at the handle end, to allow energy to be applied at different times during the procedure. The advantage of puncturing with the needle 3602 first is that it creates an anchor point in the tissue. Once the initial puncture has been made, the operator can rotate the tool until the expandable cutting arm is aligned with the desired cut length.

[0192] Furthermore, when the expandable cutting arm 3504 is pulled in the proximal direction, the cutting element 3502 can retract inward. The cutting element 3502 can retract toward the center of the cutting tool 3400. The energy applied to the cutting element 3502 can be removed to prevent accidental cutting.

[0193] Figure 37 is a cross-sectional view of a cutting tool 3400 according to one aspect of the present invention. A schematic diagram illustrates how the cutting arm of this embodiment is manufactured to allow exposed metal 3702 in a specific area to optimize the tool's cutting performance and minimize the required power input, which can use the thinnest insulating material to ensure better contact between the tissue and the exposed metal surface. A sheath 3402 without exposed metal is also provided, using an insulator 3704. In this embodiment, no cutting element or cutting arm is used. Instead, it can use radio frequency power for cutting.

[0194] Figures 38A-38E are schematic diagrams illustrating how a cutting tool can be used to optimize cutting performance and minimize power input according to one aspect of the invention. Various cutting shapes that can be produced by the embodiments through the interatrial septum are shown. These shapes can be formed using multiple cutting arms or using a single cutting arm that can be rotated and used multiple times.

[0195] Figures 39-53 illustrate a third embodiment with a delivery sheath and a helical anchor for binding tissue together. The components described below can be placed within a catheter shaft. The shaft may have multiple different lumens and channels for these components. In one embodiment, separate tools may be used for each component. These tools can travel along a guidewire in place. The techniques and / or devices shown below provide large-bore transseptal access and subsequent re-entry into the atrium.

[0196] Turning to Figure 39, an isometric view of exemplary tissue 900 traversed using an exemplary guidewire 102 according to one aspect of the invention is provided. The technique can begin with the guidewire 102 being inserted into or traversed through tissue 900. The guidewire 102 can be introduced via a vascular introduction sheath that extends upward along the head of the inferior vena cava to the right atrium. The guidewire 102 can be positioned to introduce a therapeutic or diagnostic catheter into the cardiac region.

[0197] Figure 40 is an isometric view of a suture anchor 4002 in a delivery sheath 4004 according to one aspect of the invention. In addition to the tissue anchor 4002, the delivery sheath 4004 may accommodate other components. Using a guidewire, the delivery sheath 4004 can be directed toward the tissue 900 of the interatrial septum.

[0198] Figure 41 is an isometric view of an exemplary suture anchor 4002 in a delivery sheath 4004 according to one aspect of the invention, about to penetrate tissue 900. The suture anchor 4002 can be placed at a first puncture point 4102 and a second puncture point 4104, which can be guided by a guide wire 102. Thereafter, they can be inserted into the tissue 900.

[0199] Referring to FIG42, an isometric view is provided of an exemplary suture anchor 4002 in a delivery sheath 4004 for engaging or penetrating tissue 900 according to one aspect of the invention. The suture anchor 4002 in the delivery sheath 4004 can engage or penetrate tissue 900 near the guidewire 102.

[0200] Figure 43 is an isometric view of an exemplary suture anchor 4002 engaging tissue 900 in a delivery sheath 4004 with a suture control line 4302 connected, according to one aspect of the invention. The suture control line 4302 is used to hold the suture in proper position within the tissue 900 near the guide wire 102 during surgery. The delivery sheath has been removed to expose the suture control line 4302.

[0201] Figure 44 is an isometric view of an exemplary cutting tool 4400 in a sheath position according to one aspect of the present invention. The cutting tool 4400 may be concealed within a sheath 4402. The cutting tool 4400 may be guided by a guidewire, that is, its guidance may be based on a tissue guidewire.

[0202] Turning to Figure 45, an isometric view is provided of an exemplary cutting tool 4400 in its unsheathed position according to one aspect of the invention. The cutting tool 4400 can extend beyond the sheath 4402. This can be done proximally via a propulsion mechanism passing through the sheath 4402.

[0203] Figure 46 is an isometric view of an exemplary cutting tool 4400 in its unsheathed position and deployed according to one aspect of the invention. The cutting tool 4400 may be spring-loaded, allowing it to expand symmetrically after extending beyond the sheath 4402. The cutting tool 4400 may also expand via a traction line or other mechanism. Expanding the cutting tool 4400 can facilitate tissue cutting.

[0204] Figure 47 is an isometric view of an exemplary cutting tool 4400 for making incisions or cuts in tissue 900 according to one aspect of the invention. Suture anchors 4002 in a delivery sheath can be used to hold the tissue 900 in place while allowing the cutting tool 4400 to be guided. The cutting tool 4400 can form an incision between two suture anchors 4002 in the delivery sheath.

[0205] Referring to FIG48, an isometric view of an exemplary incision 4800 in tissue 900 according to one aspect of the invention is provided, wherein a guide wire 102 passes through the incision. As the cutting tool is removed, two suture anchors 4002 connected to the suture control line 4302, together with the guide wire 102, are retained.

[0206] Figure 49 is an axonometric view of an exemplary treatment device 4900 according to one aspect of the invention being advanced through an incision in tissue 900 via a guidewire. The treatment device 4900 can be advanced via a guidewire and through an incision in tissue 900. The treatment device 4900 may be positioned between two suture anchors 4002 connected to a suture control line 4302.

[0207] Figure 50 is an isometric view of an exemplary tissue anchor lock 5000 having a helical barb 5002 according to one aspect of the present invention. The lock 5000 having the helical barb 5002 can be implanted into tissue, as will be shown below, to close an incision.

[0208] Turning to Figure 51, an isometric view of an exemplary tissue anchor 5000 according to one aspect of the invention is provided, the tissue anchor 5000 having a helical barb engaged in tissue 900 passing through suture control line 4302. In this technique, tissue 900 having incision 4800 can be twisted together with tissue anchor 5000 using the helical barb. This can secure the suture, anchor, and tissue 900 to each other.

[0209] Figure 52 is an isometric view of an exemplary tissue anchor lock 5000 according to one aspect of the invention, the lock having a helical barb engaged in tissue that extends beyond a suture control line 4302 trimmed to the level of the anchor. Excess suture control line 4302 can be trimmed using a separate cutting tool guided to the tissue with a guide wire. An incision 4800 can be closed with the lock 5000, which has a minimum control line 4302 attached thereto.

[0210] Figure 53 is an isometric view of an exemplary tissue anchor 5000 according to one aspect of the invention, having helical barbs 5002 engaged in the tissue 900 from the other side. The anchor 5000 may be distributed between the tissues 900 to heal and endothelialize with the tissues 900, or to be absorbed or dissolved. This view is located on the other side of the atrial wall shown in Figure 52. The anchor 5000 may grasp or hook onto the tissue 900 and then twist to seal the incision.

[0211] The foregoing described various techniques for closing incisions and allowing re-entry. Furthermore, Figures 54-69 provide a fourth embodiment, positioning multiple pads made of biodegradable materials and securing them together with knots to close the incision while allowing subsequent re-entry. In the following description, two pads may be used; however, fewer or more pads may be inserted into the tissue to secure the area. The pads may be composed of bioabsorbable, biodegradable materials, including but not limited to: sugars, salts, collagen, PLGA, PLLA, other absorbable polymers, magnesium, and / or other materials. The pads may be composed of combinations of various materials to promote different structural properties. Some of these materials may be conventional implant materials, such as metals or polymers, including but not limited to stainless steel, nitinol, cobalt-chromium alloys, PEEK, HDPE, etc.

[0212] Turning to Figure 54, an isometric view is provided of an exemplary pad 5402 made of a biocompatible or bioabsorbable material according to one aspect of the invention. The pad 5402 made of a biocompatible or bioabsorbable material may have control lines 5404 running through it. The pad 5402 may be a monolithic material that is elongated, with the control lines 5404 distributed between the pads 5402 and attached or secured to the ends of the pads 5402. The control lines 5404 may be distributed between pores within the pad 5402.

[0213] Figure 55 is an axonometric view of an exemplary cannula 5500 for engaging cardiac tissue 900 according to one aspect of the invention. The cannula 5500 may have a sharp distal end, but RF energy is preferably used to puncture the tissue 900. The cannula 5500 may use RF at its distal end, with an insulating covering tubular structure. The tubular structure may allow pads or other mechanisms to be distributed through it. The cannula 5500 may be inserted into a vein, such as the femoral vein, to reach the patient's heart. The cannula 5500 may be securely positioned in place. Different variations of the cannula 500 exist, and the techniques described herein are not limited to the cannula 500 shown.

[0214] Figure 56 is an isometric view of an exemplary cannula 5500 and an exemplary gasket 5402 advanced through a cannula 5500 piercing cardiac tissue 900, according to one aspect of the invention. The gasket 5402 is made of a biocompatible or bioabsorbable material. The cannula 5500 can pierce the tissue 900 with a circular incision. Typically, the incision can be very small, such that when compressed, the gasket can plug or fill the incision, providing sufficient adhesion and then tightening the tissue for subsequent closure. Other incision shapes can be used depending on the cross-section of the cannula 5500.

[0215] Referring to FIG57, an isometric view is provided of an exemplary cannula 5500 according to one aspect of the invention and an exemplary pad 5402 made of a biocompatible or bioabsorbable material extending from the cannula 5500, the cannula 5500 piercing cardiac tissue 900. A propulsion member 5702 may be inserted proximally into the cannula 5500 to force the pad 5402, with a control line 5404, into the left atrium. In one embodiment, the proximal end of the pad 5402 is connected via the control line 5404 to the distal end of the propulsion member 5702 for activating the pad by shortening the distance and expanding the cross-sectional area of ​​the pad.

[0216] Figure 58 is an isometric view of an exemplary cannula 5500 according to one aspect of the invention, which pierces cardiac tissue 900, with an exemplary pad 5402 made of a biocompatible or bioabsorbable material extending from the cannula 550, and a traction member being tightened to shorten the pad 5402. A control line 5404 can be pulled through a propulsion member 5702. The control line 5404, distributed between holes within the pad 5402, can then retract or shorten the pad 5402. This may cause the pad 5402 to clump together.

[0217] Figure 59 is an isometric view of an exemplary pad 5402 made of a biocompatible or bioabsorbable material, according to one aspect of the invention, which is stretched to shorten the pad 5402, wherein an exemplary cannula puncturing cardiac tissue 900 is withdrawn and retained on the surface of the cardiac tissue. With the withdrawal of the cannula and the shortening and compression of the pad 5402, the initial incision formed by the cannula has been plugged or secured.

[0218] Referring to FIG. 60, an isometric view of an exemplary concentric pad 6002 made of a biocompatible or bioabsorbable material according to one aspect of the present invention is provided. The concentric pad 6002 made of a biocompatible or bioabsorbable material can be introduced in a manner similar to another pad. The concentric pad 6002 can be made of the same or similar material as another pad. A control line 6004 can be attached to the concentric pad 6002, allowing the pad 6002 to be pulled back, such that the concentric pad 6002 can contract or bundle, expanding its cross-sectional area to provide greater adhesion to the tissue plane.

[0219] Figure 61 is an isometric view of an exemplary cannula 5500 according to one aspect of the invention, which punctures cardiac tissue 900 adjacent to a pad 5402. The cannula 5500 can be placed in tissue 900 adjacent to another pad 5402. Typically, as previously described, the pads can be inserted into each other to maintain the integrity of surrounding tissue and allow re-entry. This placement can provide a cutting tool placed between the pads to form an incision, and to insert a therapeutic or diagnostic device into the incision.

[0220] Figure 62 is an isometric view of an exemplary cannula 5500 for puncturing cardiac tissue 900 and an exemplary concentric pad 6002 made of a biocompatible or bioabsorbable material extending from the cannula 5500, according to one aspect of the invention. A propulsion member 5702 can be used to push or advance the pad 6002 through the cannula 5500. The pad 6002, connected to a control line 6004, can be pushed through the tissue 900 via a cannula 5500 adjacent to another pad 5402.

[0221] Figure 63 is an isometric view of an exemplary cannula 5500 according to one aspect of the invention, the cannula 5500 piercing cardiac tissue 900, an exemplary concentric pad 6002 made of a biocompatible or bioabsorbable material extending from the cannula 5500, and a traction member being tightened to shorten the pad. A control line for the concentric pad 6002 can be pulled through a propulsion member 5702. By doing so, the concentric pad 6002 can be shortened or bundled.

[0222] Referring to FIG. 64, an isometric view is provided of an exemplary concentric pad 6002 made of a biocompatible or bioabsorbable material according to one aspect of the invention, the pad being stretched to shorten the pad 6002 and an exemplary cut 6402 formed between the pads 5402 and 6002. The pads 5402 and 6002 may provide anchor points where tissues 900 can be tied together.

[0223] As previously described, a cutting tool can be used to form an incision 6402 between them. Although a straight incision is shown, other types of incisions 6402 can also be formed. These can include, but are not limited to, straight cuts, V-shaped cuts, serrated cuts, or crescent-shaped cuts. The incision 6402 can then be formed with both tissue fixation pads 5402 and 6002 in proper position.

[0224] Figure 65 is an isometric view of an exemplary medical device 4900 placed in an incision 6402 between pads 5402 and 6002 in tissue 900, according to one aspect of the invention. The incision 6402 widens when the treatment device 4900 is placed in it. The treatment device 4900 can be placed along a guidewire inserted for access to other mechanisms in the right atrium. Diagnostic devices may also be used.

[0225] Figure 66 is an isometric view of an exemplary knot 6602, having two pad control lines 5404 and 6004, advanced into cardiac tissue 900 according to one aspect of the invention. During use and removal of the treatment device 4900, the fixed knot 6602 can be advanced by tightening the control lines 5404 and 6004 of the pads.

[0226] Referring to Figure 67, an isometric view of an exemplary knot 6602 according to one aspect of the invention is provided. The knot 6602 is advanced into cardiac tissue 900, has two pad control lines 5404 and 6004, and is taut from the knot side of the tissue 900. When pulled, the control lines 5404 and 6004 can further advance the knot 6002 into the tissue 900. The control lines 5404 and 6004 can be cut to shorten them, as will be shown below.

[0227] Figure 68 is an axonometric view of an exemplary knot advanced into cardiac tissue 900 according to one aspect of the invention, wherein two pad tension lines are pulled taut from the pad side of the tissue 900. When taut, pads 5402 and 6002 can collapse toward each other, with the tissue 900 folded between them.

[0228] Figure 69 is an isometric view of an illustrative incision 6402 closing between pads according to one aspect of the invention. The control lines used to create the knot 6602 can be removed or cut. This eliminates any interference within the patient's body.

[0229] In addition to sutures and mechanical devices that join tissue edges together, adhesive materials can serve as primary, supplementary, or accessory mechanisms for sealing or joining tissues. These materials may include, but are not limited to, adhesives such as cyanoacrylates, methoxypropyl cyanoacrylates, alkyl cyanoacrylates such as n-butyl cyanoacrylate, isobutyl cyanoacrylate, or n-octyl cyanoacrylate, octyl cyanoacrylate, butyl cyanoacrylate, etc. Surgical adhesives (BioGlue), bovine serum albumin (BSA), purified glutaraldehyde (BSA), extracellular matrix (ECM) from human connective tissue, autologous and homologous fibrin sealants, fibrin glue, polyethylene glycol (PEG)-based hydrogel sealants, hydrogels, methacryloyl-substituted elastin (MeTro), etc. These sealants can be biocompatible and absorbable.

[0230] In one embodiment, a bipolar catheter-type device can be used to seal the tissue together. For example, a bipolar coagulation forceps used for hemostasis can be used. There may be surgical sequence options to complete this procedure.

[0231] Figure 70 is an illustrative flowchart illustrating an exemplary process according to one aspect of the invention, for allowing a large-bore transseptal entry followed by atrial re-entry. These processes are for illustrative purposes and can be modified according to the techniques described herein. The process may begin at block 7000.

[0232] In block 7002, a guidewire can be inserted into the ventricle and distributed across the interatrial septum. The guidewire can be inserted into the venous circulation system via a vascular access sheath. For example, the initial percutaneous puncture or incision may be made in the patient's femoral vein. Other areas the guidewire can enter within the patient's body may include, but are not limited to, the jugular vein, subclavian artery, subclavian vein, or brachial artery and vein.

[0233] The guidewire can be advanced along the head of the inferior vena cava to the right atrium of the heart. The guidewire can be placed in the interatrial septum for use in introducing a therapeutic or diagnostic catheter into the cardiac region. Conversely, the guidewire can be temporarily or detachably secured to the interatrial septum.

[0234] In box 7004, a needle can be used to puncture the left atrium through the interatrial septum. The septal puncture device can be a needle or an axially elongated structure with a sharp tip. In one embodiment, the septal puncture device can be located within a guidewire. The septal puncture device can be actuated at the proximal end of the vascular device by a control mechanism such as a button, lever, handle, or trigger, which can be permanently or detachably fixed by a linkage, push rod, electrical bus, etc., extending along the length of the device.

[0235] Guidewires can be used as puncture devices. Guidewires may have tips that facilitate passage through septa, such as, but not limited to, tips, spiral ends, RF energy electrode tips, other energy tips, or other devices that facilitate tissue penetration.

[0236] In block 7006, the suture can be pulled through the perforation via an anchor. The suture can be bundled in a suture bundle and stored in the recess of the anchor. The catheter shaft can be positioned in the right atrium, and the anchor with the suture bundle is advanced into the left atrium via puncture. Conversely, the suture bundle can be untied by a snare that catches a needle attached to the end of the suture. The snare with the needle can be pulled into the catheter shaft. The suture from the suture bundle can be managed via the snare.

[0237] The sutures can be placed from the right atrium to the left atrium, or from the left atrium to the right atrium, depending on the device. Multiple sutures can be placed repeatedly across the intercostal spaces. The sutures can also be another type of device, such as a spiral anchor or barbed device. Suture placement can also be provided after block 7012 when the treatment is complete.

[0238] In block 7008, and after the suture is in the proper position, a cutting tool can be used to cut the interatrial septum near the needle channel. The suture can be spread through a hole near the initial puncture site. The resulting incision or cut can be parallel so that the suture is not cut by the cutting tool. The cutting tool can be attached to a catheter to ensure that the cutter does not accidentally cut the suture.

[0239] This document describes various cutting tools. Mechanical energy or radio frequency energy can be used. When using electrical energy, the amount of exposed metal can be minimized through insulation, so that the exposed metal is only present in the desired tissue cutting area of ​​the tool. Mechanical energy can be achieved using blades that can be deployed in a single direction or can be symmetrical. Depending on the device, cutting can be performed from right atrium to left atrium or from left to right. Cutting can be performed after anchor placement. Alternatively, cutting can be performed after placement of the suture anchor, as described in block 7006. Cutting can be integrated into the above blocks 7002 and 7004 using devices for puncturing and cutting tissue.

[0240] In block 7010, sutures can be managed. That is, the sutures can be pulled towards the vessel wall and moved or manipulated so that they do not interfere with or entangle the treatment device catheter. Tissue suture management lines can be managed either within the lumen of the sheath or in a separate catheter.

[0241] In block 7012, treatment can be performed using a therapeutic device. This device can perform diagnostic and therapeutic interventions to correct atrial fibrillation, perform mitral valve repair, correct septal defects, and implant cardiac prostheses. Treatment or diagnosis can be performed within the left atrium. The therapeutic device can then be removed.

[0242] In block 7014, control sutures can be used to close the incision. The amount of this closure can be adjusted to meet the desired treatment goals of the surgery. It may be necessary to completely seal the incision, or leave a channel for releasing excess pressure from one side to the other. In one example, the control sutures can be pressed against the aforementioned tissue. The procedure can end in block 7016.

[0243] Other techniques can be used to allow large-bore access through a septum and then into the atrium. For example, in this embodiment, the method may include puncturing the septum to allow a needle to pass through, leaving sutures or other anchors, and then performing the procedure. The left-behind anchors or sutures can be tied together to close the septum. Excess sutures can be cut off.

[0244] In another technique used for atrial re-entry, the septum can be incised first. The septum can be stabilized by the needle puncture radius, allowing the needle to pass through the previously incised septum. A needle insertion device can then be introduced. The needle on the left atrial side can then be hooked / grabbed and passed through the catheter. In turn, pre-formed nitinol sutures can be used to loop through the septum. Control structures can be used to close the incision and cut off any excess sutures.

[0245] In another technique, transseptal entry can be achieved using a standard transseptal approach. A guidewire is passed through the transseptal entry site in the left atrium. A vascular device for cutting, dilating, and placing sutures is advanced over the guidewire. Four radially spaced cutting members can cut the septum in a controlled and consistent manner and dilate the transseptal entry point. A needle can then puncture the septum and allow the sutures to pass through the atrial tissue between the slices, so that they optimally close the iatrogenic ASD when sutured together. The vascular device can then be removed, leaving the four sutures in their proper positions on the septum. The sutures can be pulled out from the vein and temporarily left in their proper positions in the inferior vena cava until later in the procedure.

[0246] In another technology, mechanisms that facilitate the delivery of sutures, anchors, cutting tools, and closure features can be integrated into the treatment device to minimize device replacements within the patient's body.

[0247] In another technique, no foreign body is left behind. This technique, along with one or more associated devices, allows access to the atrium post-operatively and tightens the tissue to be sutured for a period of time to promote healing while sealing it. Conversely, the technique may include removing the structure or device. This technique can be a combination of a controlled incision and subsequent tightening with the devices described herein or known in the art. These devices may include, but are not limited to, graspers, forceps, spiral anchors, clamps, knots, suction devices, barbs, etc. Due to the morphology of the incision, this technique can promote tissue self-healing. The duration of this temporary attachment can range from minutes to days or weeks, depending on the amount of tissue healing required.

[0248] In some embodiments, the anchor described above may subsequently be removed from the tissue, or optionally left in place. Techniques or procedures for removing the anchor may utilize grippers, snares, cutting elements, or engagement features specific to mechanisms for leaving the anchor in place. A mechanical feature may be added to the right atrial side of the anchor device so that it can be subsequently grasped and loosened. This mechanical feature may be hook-shaped, oval, or the like. For example, the feature may protrude from the right atrial septum, allowing it to be grasped with a snare and twisted out of the tissue.

[0249] The foregoing description is provided to enable any person skilled in the art to practice the various embodiments described herein. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein can be applied to other embodiments. Therefore, the claims are not intended to limit them to the embodiments shown and described herein, but are to be accorded the full scope consistent with the language of the claims, wherein, unless specifically stated otherwise, the singular form of an element is not intended to mean "one and only one," but rather "one or more." All structural and functional equivalents of elements known or to be known hereafter by a person of ordinary skill in the art throughout the various embodiments described herein are expressly incorporated herein by reference and are intended to be contained in the claims. Furthermore, nothing disclosed herein is intended to be offered to the public, whether or not such disclosure is expressly stated in the claims.

Claims

1. A vascular device for performing transseptal puncture, comprising: main body; An anchor that extends from the far end of the body through an axis set within the body; At least one suture thread is attached to at least one needle inside the anchor; At least one hook extending from the body, the hook being used to pull at least one needle into the body to place at least one suture; and A cutting tool, located between the body and the anchor, is connected to an actuation shaft aligned with at least one suture line.

2. The vascular device for performing transseptal puncture according to claim 1, comprising a guidewire disposed within the body and the anchor.

3. The vascular device for performing transseptal puncture according to claim 1, wherein, The surfaces of the main body and the anchor are at an angle.

4. The vascular device for performing transseptal puncture according to claim 1, wherein, The body includes a rectangular cavity for the shaft of the anchor.

5. The vascular device for performing transseptal puncture according to claim 1, wherein, The body includes at least one cavity for the at least one gripper.

6. The vascular device for performing transseptal puncture according to claim 1, wherein, The at least one suture is stored in the recessed channel of the anchor.

7. The vascular device for performing transseptal puncture according to claim 6, wherein, The at least one suture includes two ends, which are connected to two needles extending toward the body.

8. The vascular device for performing transseptal puncture according to claim 6, wherein, After the at least one suture is pulled by the at least one hook, the recessed channel releases the at least one suture.

9. The vascular device for performing transseptal puncture according to claim 1, wherein, The device includes two sutures, each suture connected to two needles.

10. The vascular device for performing transseptal puncture according to claim 1, wherein, The at least one gripper is pulled from the proximal end of the body.

11. The vascular device for performing transseptal puncture according to claim 1, wherein, The actuation shaft of the cutting tool extends and retracts on the shaft of the anchor.

12. The vascular device for performing transseptal puncture according to claim 1, wherein, The cutting tool expands radially from the body via the actuation shaft.

13. The vascular device for performing transseptal puncture according to claim 12, wherein, The actuation shaft causes the cutting tool to bend by a length greater than the diameter of the body.

14. The vascular device for performing transseptal puncture according to claim 12, wherein, The actuation shaft causes the linkage system to expand the cutting tool.

15. The vascular device for performing trans-segmental puncture according to claim 1, wherein the cutting tool uses mechanical or electrical energy.

16. The vascular device for performing transseptal puncture according to claim 15, wherein the mechanical energy or electrical energy originates from at least one of a blade, ceramic, electrocautery, radiofrequency, plasma jet vaporization, ultrasound, high-pressure vaporization, controlled dilation, heat, and cold.

17. A spacer closure device that allows re-entry, comprising: The main body is located on the first side of the septal foramen in the septum of the heart; An anchor, located on the second side of the spacer hole, extends from the distal end of the body through a shaft disposed within the body; At least one suture thread is attached to at least one needle located inside the anchor; At least one hook extending from the body, the hook being used to pull at least one needle into the body to place at least one suture; and A cutting tool, located between the body and the anchor, is connected to an actuation shaft aligned with at least one suture line.

18. The spacer hole closing device according to claim 17, wherein, The cutting tool uses mechanical or electrical energy.

19. The spacer hole closing device according to claim 17, comprising a guide wire disposed within the body.

20. The spacer hole closing device according to claim 17, wherein, The cutting tool includes a first circuit for the first puncture and a second circuit for the larger cut.

21. The spacer hole closing device according to claim 17, wherein, The cutting tool includes a pull ring or spring to open and close the cutting tool.

22. A vascular closure device, comprising: An anchor, which is positioned through a perforation in the vessel wall and can be operated between a retracted and expanded position from the main body; At least one suture is placed inside the anchor; At least one needle, which is attached to at least one suture and extends through the vessel wall near the perforation, to connect at least one suture when the anchor is in the dilated position; At least one hook extending from the body, the hook being used to pull at least one needle into the body to place at least one suture; and A cutting tool, located between the body and the anchor, is connected to an actuation shaft aligned with at least one suture line.

23. The vascular closure device according to claim 22, wherein, The anchor includes a recessed channel for storing at least one suture.

24. The vascular closure device according to claim 23, wherein, The recessed channel is shaped to allow the at least one suture to be untied when the at least one suture is pulled by the at least one hook.

25. The vascular closure device according to claim 22, wherein, The anchor can operate between a retracted position and an expanded position to capture the vessel wall between the anchor and the body.

26. The vascular closure device according to claim 22, wherein, The at least one needle extends from the anchor toward the body.

27. The vascular closure device according to claim 22, wherein, The body includes a cavity for at least one gripper.

28. The vascular closure device according to claim 22, wherein, The main body includes four cavities and four hooks for hooking the four needles of the two sutures.

29. The vascular closure device according to claim 22, wherein, The cutting tool expands radially from the body via an actuation shaft.

30. The vascular closure device according to claim 29, wherein, The cutting tool, which expands radially from the body, is parallel to at least one suture line.

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