Device allowing large bore transseptal access with subsequent atrial re-access and method thereof

Abstract

To provide a vascular device for performing transseptal puncture.SOLUTION: The present disclosure relates to medical devices. A vascular device is described that allows large bore transseptal access with subsequent atrial re-access by pre-placing closures / tissue approximating sutures prior to creating a septostomy. Generally, the device may include a delivery catheter for puncturing and cutting the interatrial septum. An anchor of the delivery catheter may secure the suture in an atrium to a septum wall, for example, the left atrium. Incisions may be made by an expandable cutting implement which may use mechanical energy or radio frequency (RF) energy without interfering with the suture. A therapeutic instrument may be advanced through a tissue plane after the incisions are made by the cutting implement. Closure of the incision may be performed with the previously placed sutures.SELECTED DRAWING: Figure 4

Description

Related Disclosure

[0001] This disclosure claims priority to U.S. Provisional Application No. 63 / 036,435, filed Jun. 8, 2020, entitled “Large Bore Septal Closure” and U.S. Provisional Application No. 62 / 873,383, filed Jul. 12, 2019, entitled “Large Bore Atrial Preclose”, both of which are hereby incorporated by reference in their entirety.

Technical Field

[0002] This disclosure relates to medical devices, and more particularly to transcatheter delivery atrial septal crossing and closure procedures for large-bore instruments that enable access to the atrium (e.g., left atrium) and subsequent atrial re-access.

Background Art

[0003] In left heart catheterization procedures, it appears that a method of puncturing and crossing the atrial septum using a mechanical or radiofrequency (RF) needle has generally become common. With small-bore (typically less than 24 French) catheters, this procedure is generally straightforward. However, when delivering a larger catheter or bore to the atrial septum, it is typical to expand the puncture site to pass the catheter through the septum. Current methodologies for initially expanding the septal puncture site may involve using a dilator or inflating a balloon to open the access site. In this case, the physician may need to exchange instruments several times, and since the expansion technique is inherently uncontrollable, there is a risk of causing an unfavorable impact on the tissue.

[0004] Furthermore, minimally invasive catheter-based treatment methods have been developed, which allow physicians to provide treatment to patients with existing co-morbidities who are not candidates for invasive surgical procedures, although necessary. In recent years, catheter-based surgery for mitral valve repair or replacement has been developed and may use large-bore transseptal access. Transseptal puncture can lead to the formation of iatrogenic atrial septal defects, which may then need to be closed with an atrial septal defect treatment device. However, that atrial septal defect treatment device may interfere with or complicate subsequent transseptal crossings.

[0005] The present disclosure provides a device and method that enable large-bore transseptal access with subsequent atrial re-access to address the above-identified concerns. Described herein is a controlled and accurate atrial septotomy that allows passage of a large-bore device across the atrial septum and then provides rapid and forgiving closure of the atrial septal defect formed by the procedure. The term "forgiving" can be defined as a mechanism by which the septal defect is closed and allows future crossing of the atrial septum by standard transseptal methods. Other benefits and advantages will become apparent from the disclosure provided herein, and these benefits provided are for illustrative purposes only. The description of this section merely shows the background related to the present disclosure and does not constitute prior art. SUMMARY OF THE INVENTION

[0006] This summary is provided to introduce a simplified selection of concepts that are further described below in the "Description of the Disclosure". This summary is not intended to identify key features of the subject matter recited in the claims, nor is it intended to be used as an aid in determining the scope of the subject matter recited in the claims.

[0007] According to one aspect of the present disclosure, a vascular device for performing transseptal puncture is provided. The device may include a body, an anchor extending through a shaft disposed within the body from a distal end of the body, at least one suture coupled to at least one needle within the anchor, at least one catch extending from the body for retracting at least one needle into the body for disposing at least one suture, and a cutting instrument between the body and the anchor coupled to an actuation shaft aligned with at least one suture.

[0008] According to yet another aspect of the present disclosure, a septal opening closure device that enables re-access is provided. The device may include a body on a first side of an opening in the septum of the heart, an anchor on a second side of the septal opening extending through a shaft disposed within the body from a distal end of the body, at least one suture coupled to at least one needle disposed within the anchor, at least one catch extending from the body for retracting at least one needle into the body for disposing at least one suture, and a cutting instrument between the body and the anchor coupled to an actuation shaft aligned with at least one suture.

[0009] According to yet another aspect of the present disclosure, a vascular closure device is provided. The device may include an anchor disposed through a puncture in a vessel wall and operable between a position retracted into the body and a position expanded from the body, at least one suture disposed within the anchor, at least one needle extending through the vessel wall adjacent to the puncture for connecting at least one suture when the anchor is in the expanded position and coupled to the at least one suture, at least one catch extending from the body for retracting at least one needle into the body for disposing at least one suture, and a cutting instrument between the body and the anchor coupled to an actuation shaft aligned with at least one suture.

[0010] According to another aspect of the present disclosure, a method of making a septal crossing in a vascular wall is provided. The method may include providing a delivery catheter having a body and an anchor, inserting the anchor through a puncture in the vascular wall, manipulating the anchor to an expanded position that captures the vascular wall between the body and the anchor and exposes at least one needle, capturing at least one needle to engage at least one suture thread through the vascular wall adjacent to the puncture, and disposing at least one suture thread on the vascular wall.

[0011] According to one aspect of the present disclosure, a vascular device is provided. The device may include a delivery system having at least one anchor that penetrates a tissue plane, the delivery system having at least one anchor having a suture thread, an incision instrument disposed in the tissue plane to facilitate an incision, a treatment instrument that enters the incision, and a fastener that secures the suture thread to the tissue in the tissue plane.

[0012] According to yet another aspect of the present disclosure, a septal opening closure device is provided. The device may include a first pledget introduced into a tissue plane through a cannula, the first pledget being connected to a control wire that applies tension to the first pledget after introduction into the tissue plane, a second pledget introduced into the tissue plane through the cannula, the second pledget being connected to a control wire that applies tension to the second pledget after introduction into the tissue plane, an incision instrument that forms an incision between the first pledget and the second pledget, a treatment device that passes through the incision, and a knot that includes control wires of the first pledget and the second pledget and controls the tension of the first pledget and the second pledget with tissue from the tissue plane therebetween.

[0013] According to another aspect of the present disclosure, a device for puncturing a patient's atrial septum is provided. The device may include a body, a tip extending from a distal end of the body, and a collapsed incision member disposed between the body and the tip, the tip and subsequently the incision member penetrating into the tissue plane, the incision member expanding after passing through the tissue plane.

[0014] According to one aspect of the present disclosure, a vascular device is provided. The device may include a delivery system, a tip extending from the distal end of the delivery system, and a cutting instrument disposed between the delivery system and the tip.

[0015] According to yet another aspect of the present disclosure, a method of instrumenting the left atrium is provided. The method may include puncturing the septum with a needle, placing at least one suture behind the septum, advancing a treatment instrument into the puncture site, and tightening at least one suture to close the puncture site.

[0016] According to yet another aspect of the present disclosure, a method of closing a septal opening is provided. The method may include forming a transseptal access via a wire, inserting a delivery catheter over the wire, enlarging the transseptal access with a cutting instrument of the delivery catheter, inserting at least one suture connected to a needle passing around the transseptal access, tightening the transseptal access with at least one suture, and removing the delivery catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The features that are considered to be novel to the present disclosure are set forth in the appended claims. In the following description, like parts in this specification and the drawings are denoted by the same numerals respectively. The figures in the drawings are not necessarily drawn to scale, and certain figures may be shown in exaggerated or generalized form from the viewpoints of clarity and conciseness. However, the present disclosure itself, as well as its preferred usage modes, further objectives, and advantages, will be best understood by referring to the following detailed description of exemplary embodiments in conjunction with the appended drawings.

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[0088] The following description, which relates to the accompanying drawings, is intended as a description of exemplary embodiments of the present disclosure and is not intended to represent the only form in which the present disclosure may be constructed and / or utilized. This description shows the order of functions and blocks for constructing and operating the present disclosure in relation to the illustrated embodiments. However, it is understood that the same or equivalent functions and sequences may be achieved by different embodiments that are also intended to be encompassed within the spirit and scope of the present disclosure.

[0089] The present disclosure relates to medical devices. More particularly, the present disclosure describes a vascular device that enables large-bore transseptal access with subsequent atrial re-access by pre-positioning a closure / tissue approximation suture prior to forming a septal opening. Generally, the device may include a delivery catheter for puncturing and incising the atrial septum. The anchor of the delivery catheter may secure a suture within the atrium to the septal wall, e.g., the left atrium. The incision may be made with an expandable cutting device that may use mechanical energy or radiofrequency (RF) energy without interfering with the suture. The suture may be made of a high-temperature resistant material so that it does not break even when in contact with the cutting device. After forming an incision with the cutting device, a therapeutic instrument may be advanced through the tissue plane. Closure of the incision may be performed with the previously inserted suture.

[0090] Numerous other modifications or configurations to the vascular device will be apparent from the description provided below. For example, when closing an incision in the atrial septum, a needle that punctures the septum and pushes an anchor into the tissue may be involved. Also, control lines tied to two or more pre-jets may be used and placed on the tissue plane via a cannula to facilitate tissue edge overlap or apposition.

[0091] Advantageously, a first puncture that performs suture management nearby tolerates multiple instruments within a single delivery catheter access in the atrial septum while rapidly closing iatrogenic atrial septal defects (ASDs) created by the procedure. Since the incision can be easily tightened, re-access is possible through the anchor and suture. This vascular device is thought to be useful in procedures that require large-bore transvenous access to the left atrium in transcatheter mitral valve replacement, where it is common for a large ASD to remain with the delivery system. Other benefits and advantages will be apparent from the disclosure provided herein, and these advantages provided are for illustrative purposes only.

[0092] Figures 1-5 depict a human venous circulatory system including a heart with an exemplary vascular device with a guidewire defined therein, and Figures 6-23 illustrate a first embodiment of a device with an exemplary incision. Figures 24-38 illustrate a second embodiment of a vascular device with additional exemplary incisions. Figures 39-53 illustrate a third embodiment with a delivery sheath and a helical anchor for tying tissue. Figures 54-69 provide a fourth embodiment in which a plurality of pre-jets and sutures made of a biodegradable material are arranged and fixed together with knots enabling re-access. Figure 70 provides various techniques. The components described below within the embodiments may be exchanged, removed, or added to one another to come up with derivatives of the devices within the scope of the present disclosure.

[0093] Turning to FIG. 1, a front schematic view of an exemplary human venous circulatory system of a patient 100 with a guidewire 102 routed from the femoral vein 104 to the right atrium 106, according to one aspect of the present disclosure, is provided. The guidewire 102 may enable a continuous presence where a plurality of tools may be exchanged. For example, with these tools, pre-closure suturing, subsequent controlled atrial septal resection by a retractable blade, delivery of a large-bore catheter and other medical instruments into the left atrium may be performed.

[0094] First, as illustrated, a vascular introduction sheath 112 may be inserted into the right femoral vein 104 via a transseptal puncture or incision. Alternatively, the vascular introduction sheath 112 may be placed in non-femoral locations such as the jugular vein, subclavian artery, subclavian vein, brachial artery and vein. Other approaches and access sites may include an approach to the leg opposite the therapeutic catheter.

[0095] The guidewire 102 may be inserted through the vascular introduction sheath 112 and routed cephalad in the inferior vena cava 110 to the right atrium 106, which is one of the chambers of the heart 108. In this figure, the anatomical left side of the patient 100 is towards the right. The guidewire 102 may be arranged to be used to guide a therapeutic or diagnostic catheter into the region of the heart 108.

[0096] The venous circulation in which the guide wire 102 is routed may generally be at a lower pressure between 0 and 20 mmHg than the systemic circulation of which the descending aorta is a part. The pressure within the systemic circulation may range from 60 mmHg to over 300 mmHg, depending on the level of hypertension or hypotension present in the patient 100. By accessing the heart 108 at the femoral vein 104 through the venous circulation, the likelihood of bleeding from the catheter insertion site can be minimized.

[0097] FIG. 2 is a front schematic view of an exemplary human venous circulatory system of a patient 100 with an exemplary vascular device 200 that has entered the right atrium 106, according to one aspect of the present disclosure. FIG. 2 is a front view looking from the front side to the back side of the patient 100. The vascular introduction sheath 112 of FIG. 1 has been removed from the right femoral vein 104, and the vascular device 200 is inserted into the venous circulation on the guide wire 102. The device 200 may be routed from the inferior vena cava 110 to the right atrium 106 of the heart 108 via the same guide wire 102 used by the introduction sheath.

[0098] Referring to FIG. 3, there is shown a cross-sectional illustration of the heart 108 with an exemplary vascular device 200 disposed in the atrial septum 300 and a septal penetrator 304 that has entered the left atrium 302 across the atrial septum 300, according to one aspect of the present disclosure. The ascending aorta, aortic valve, pulmonary artery, and pulmonary valve have been removed from this figure for clarity and to show the atrial septum 300. The body of the vascular device 200, which is substantially located within the right atrium 106, is shown such that its long axis is perpendicular to the atrial septum 300. The proximal end of the vascular device 200 is shown to be within the inferior vena cava 110. The septal penetrator 304 extends through the puncture portion 306 of the atrial septum 300 and is routed to the left atrium 302 at the distal end of the vascular device 200.

[0099] The septal penetrator 304 may be a needle having a sharp distal end or a structure elongated in the shaft direction. The septal penetrator 304 may be within the guide wire 102, and the penetrator 304 may be removable. The septal penetrator 304 can be actuated at the proximal end of the vascular device 200 via a control mechanism such as a button, lever, handle, or trigger, and this mechanism may be permanently or removably attached via a connecting portion, pusher rod, electrical bus, etc. that runs along the length portion of the device 200.

[0100] In surgery, the septal penetrator 304 passing through the wall of the left atrium 302 facing the atrial septum 300 may be guided and advanced using fluoroscopy, magnetic resonance imaging (MRI), ultrasound, etc. Care may be taken not to inadvertently pierce the aorta via the penetrator 304 in the region upstream or anatomically proximal to the aortic arch of the patient 100. The distal portion of the vascular device 200 may be bent, deflected, or articulated at an angle between 30 degrees and 120 degrees so as to be substantially perpendicular to the atrial septum 300.

[0101] The septal penetrator 304 may be solid, may be hollow like a hypodermic needle, or may have a "U" - shaped or "C" - shaped cross - section. The center or core of the hollow "C" or "U" - shaped septal penetrator 304 may be filled with a guide wire or other core element to prevent accidental tissue penetration. The septal penetrator 304 may be rigid or flexible but retain column strength. Such a flexible configuration may include notches provided in the wall of the penetrator 304 or structures like guide wires. The septal penetrator 304 may initially be straight or initially be curved. The septal penetrator 304 may be made of a shape - memory material such as nitinol and may be heat - treated to cause curvature when the material is heated from the martensite temperature to the austenite temperature. Such heating can be done using electrical heating, warm water injection, etc. The septal penetrator may utilize energy such as RF (radio frequency) to facilitate penetration of septal tissue.

[0102] Referring to FIG. 4, a cross-sectional view of the heart 108 is shown with an exemplary vascular device 200 advanced into the left atrium 302 across the atrial septum 300 and the septum penetrator withdrawn. The vascular device 200, which is expanded at the distal portion, is entering the left atrium 302 from the right atrium 106 across the atrial septum 300 through the puncture portion 306. Through this, the distal portion of the vascular device 200 may provide for the placement of closure sutures or other instruments.

[0103] The proximal region, or body, of the vascular device 200 is advancing such that the proximal region is positioned not only within the inferior vena cava 110 but also within the right atrium 106. This may be guided by the fluoroscopy, MRI (magnetic resonance imaging), ultrasound, etc. described above.

[0104] FIG. 5 shows an exemplary initial incision 502 or 506 according to one aspect of the present disclosure, and is a cross-sectional explanatory view of the heart 108 that is lengthened to a length selected / controlled by the user thereafter. A cross-sectional view of the heart 108 as seen from the right atrium side is shown. The atrial septum 300 may be surrounded by the superior vena cava margin 510 of the superior vena cava 512, the posterior vena cava margin 514, the inferior vena cava margin 516 of the inferior vena cava 110, the atrioventricular valve margin 518, the aortic margin 520, and the superior margin 522. The vascular device 200 may form an adjustable and controllable atrial septotomy defined by the user by a retractable cutting instrument in relation to the closure via sutures formed by the atrial septotomy.

[0105] After puncturing the atrial septum 300 with the septum penetrator at an ideal position, the distal end of the vascular device 200 may be inserted through the tissue plane. The first incision 502 or 506 of the atrial septal wall may be formed and then lengthened to a predetermined desired amount 504 or 508 suitable for enabling the treatment instrument. Further, position control and visualization may allow avoiding anatomic regions 524 such as the aortic margin 520 or the superior margin 522 that are undesirably obstructive, or puncturing outside the atrium, or incising the myocardium.

[0106] The target of the tissue incision portion 502 or 506 may be on the atrial septum 300 at a position that enables access to a desired treatment target such as the mitral valve. As an example, the length or size of the incision can be set to accommodate a treatment instrument or device without further damaging the tissue plane. The tissue incised to a specific length of sufficient size may be facilitated so that the tissue does not tear beyond the desired incision length. This can be achieved by matching the periphery of the incision portion 502 or 506 with the periphery of the treatment instrument along with the desired amount 504 or 508. In one embodiment, by making an incision slightly larger than the subsequent treatment catheter, flexibility may be provided to the user. In a general septum puncture portion, if the initial puncture site is inappropriate, the user has to retract the catheter and perform re-puncture and re-dilation, and there is a risk of tissue tearing.

[0107] Also, the length may be adjusted in consideration of the expansion and contraction of the tissue plane. The tissue edge around the atrial fossa may be used or referred to in order to initiate or limit the tissue incision portion 502 or 506. Extending the incision portion 502 or 506 beyond or outside the edge of the fossa requires more force or energy to form, and thus is utilized as a feedback loop for determining the position of the incision portion 502 or 506.

[0108] In an example shown below, the vascular device 200 may have one incision arm and a centering puncture member. In this configuration, the surgeon may rotate the tool to form a slit in a desired direction. The edge of the fossa of the heart 108 may be used as a starting point because it is easier to first puncture this point and then rotate the incision member to make an incision along any direction. Also, two symmetric incision arms extending from the center (with or without a central puncture plane) may be used. With this configuration, the doctor can puncture at a known height or position, and since the incisions are symmetric, it can be confirmed that the center of the incision is at the position intended by the doctor.

[0109] Turning to FIG. 6, which discloses the first embodiment, an exemplary side view of an exemplary vascular device 200 according to one aspect of the present disclosure is provided. The vascular device 200 may have a distal region that may be a tip or an anchor that is expandable from the body of the device 200. The length of the sheath tube 606 may extend the body up to the 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 from the exit path of the guidewire 102. As shown, the sheath hub 608 may be a transport hub 608. The hub 608 may be configured to have fewer or more ports in other embodiments. A plurality of instruments may be inserted or withdrawn into the hub 608 shown below.

[0110] Generally speaking, the vascular device 200 can be used to place sutures in the atrial septum either before or after forming a septal opening controlled via an instrument disposed in the hub 608. Other medical devices can enter the left atrium to confirm its position and then close the ASD. Advantageously, the way the ASD is closed can allow for future tissue crossing if necessary for subsequent catheter-based procedures.

[0111] Turning to FIG. 7, an isometric view of the distal end of an exemplary vascular device 200 in a low-profile state according to one aspect of the present disclosure is provided. The device 200 can enable placement of atrial septal resection closure sutures prior to introduction of a cutting instrument, i.e., blade septotomy. The entire device 200 may travel over a guidewire disposed in the atrial septum through the right atrium.

[0112] The vascular device 200 described herein facilitates forming access incisions in tissue planes such as the atrial septum to a controlled or adjustable size and position, and enables a treatment instrument or catheter to easily effect controlled closure of the incision after the procedure is complete. The closure may be adjusted to be hemodynamically sealed or, conversely, may allow a certain amount of flow. The treatment device may perform diagnostic and therapeutic interventions, for example, for atrial fibrillation correction, mitral valve repair, septal defect correction, or implantation of an artificial heart.

[0113] 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, a polymeric material. An elastomeric material may be used to construct the catheter shaft 702 to maximize flexibility. These materials may be used to form the inner and outer walls of the shaft 702. The reinforcement structure within the device 200 may be made of a metal such as stainless steel, titanium, etc. In this embodiment, the reinforcement structure is malleable but retains sufficient strength to overcome the applied forces.

[0114] The catheter shaft 702, i.e., the delivery catheter, may have a body that is a tubular structure. The shaft 702 may have a circular cross-section in one embodiment to accommodate components. These components may extend towards the proximal end of the vascular device 200. The left atrial appendage implant described below may be radially collapsible during delivery via the shaft 702. In one embodiment, the implant may be delivered through a catheter of 14 French or larger with a radially expandable delivery sheath.

[0115] Continuing with FIG. 7, the anchor 704 of the vascular device 200 may be delivered to the atrial septum and may be extendable from the catheter shaft 702. The anchor 704 and the catheter shaft 702 may incorporate components that serve a specific function to enable the delivery of a suture that traverses tissue from a remote location. The anchor 704, which is an object of the present embodiment, may be conical. Alternatively, the anchor 704 may have a funnel-shaped, rounded, inclined, or pointed shape, but is not limited thereto. The anchor 704 may have a chamfered edge that can conform to the atrial septum.

[0116] A guidewire lumen 706 may be present in the running portion or inside the catheter shaft 702 and the anchor 704 of the vascular device 200. The lumen 706 may enable the vascular device 200 to be advanced and delivered over a previously placed guidewire. The guidewire described above may ascend from the femoral vein to the inferior vena cava and enter the patient's body and into the right atrium. The septum penetrator for making the initial puncture may be within the guidewire and may be removable therefrom.

[0117] FIG. 8 is an isometric view from another perspective of the distal end of an exemplary vascular device 200 with a portion of the device 200 advanced, showing the components used to puncture tissue and pass a suture therethrough, according to one aspect of the present disclosure. The anchor 704 having a conical shape may enter the patient's heart from the tip of the catheter shaft 702. The amount of distance the anchor 704 advances may depend on the thickness of the tissue it traverses and the size of the chamber it enters.

[0118] The vascular device 200 may be designed to allow or restrict the amount of movement of the anchor 704. The amount of movement can range from a few millimeters to several centimeters or more. For the purposes of the present disclosure, it is assumed that the anchor 704 may cross the atrial septum from the right atrium to the left atrium, and the catheter shaft 702 may remain on the right side of the heart within the right atrium. The anchor 704 may be expanded to allow the needle 804 of the anchor 704 to catch or be grasped within the left atrium 304.

[0119] Once the anchor 704 has advanced, the needle 804 may be exposed. In one embodiment, as shown, four needles 804 may be removably coupled to the anchor 704. The needles 804 may be oriented rearwardly. For example, the needles 804 may extend toward the catheter shaft 702 or the body of the vascular device 200 when the anchor 704 extends into the left atrium. The surfaces of the catheter shaft 702 and the anchor 704 may be angled by a predetermined amount to allow for a more orthogonal contact with the tissue to promote a more stable interface between the tissue and the catheter shaft 702.

[0120] The advancement shaft 802 for the anchor 704 of the vascular device 200 may be rectangular in shape to maintain precise rotational alignment with the catheter shaft 702 and may move through a corresponding rectangular-shaped lumen within the catheter shaft 702. Typically, the alignment between the anchor 704 and the catheter shaft 702 is maintained to enable the functionality of the device. The advancement shaft 802 may be expanded or retracted at the proximal end of the vascular device 200, which proximal end may be located at the percutaneous puncture site or incision site as shown above.

[0121] Referring to FIG. 9, an isometric view of the distal end of an exemplary vascular device 200 having a portion of the device 200 advanced through the atrial septal tissue 900 according to one aspect of the present disclosure is provided. The vascular device 200 is disposed through a representative portion of the tissue 900. The anchor 704 having a conical shape is entering across the puncture site of the tissue 900 previously made by the septal penetrator. The catheter shaft 702 may be larger than the puncture made by the septal penetrator, and thus prevent the catheter shaft 702 from entering into the tissue 900. Thereby, the tissue can be adhered or fixed around the narrow side of the device.

[0122] FIG. 10 is a cross-sectional view of an exemplary vascular device 200 having an exemplary lumen configuration according to one aspect of the present disclosure. The catheter shaft 702 may include a plurality of channels or lumens that allow certain components to pass therethrough. As an example, four lumens 1002 having equal diameters may allow a snare to capture, hook, or loop a needle removably coupled to an anchor with a tether suture and pass therethrough. The central rectangular channel 1004 may allow the rectangular advance and retract shaft of the anchor to move therethrough. With this configuration, the positional relationship between the four needles and the cutting instrument shown later can be maintained within the catheter shaft 702.

[0123] The different configurations for the cross-section of the vascular device 200 can be implemented according to the arrangement of the suture. For example, more than four lumens 1002 may each communicate through a catheter shaft 702 that is equidistant from the center. Advantageously, the lumens 1002 can provide an appropriate spacing for the first puncture so that the suture can be managed. The puncture portions used to capture the needles in the lumens 1002 may be arranged so that unnecessary tearing of the tissue does not occur and an appropriate suture arrangement is performed. In the illustrated configuration, two sutures can be performed through four needles, but other configurations may exist and are within the scope of the present disclosure. In one embodiment, the opening may radially surround the central lumen so that the user can selectively pass any number of needles / sutures. The suture may be loaded from the proximal end in any configuration selected by the user.

[0124] FIG. 11 is an isometric cross-sectional view of the distal end of an exemplary vascular device 200 showing the internal shape of the components therein, according to one aspect of the present disclosure. For illustrative purposes, a portion of the anchor 704 has been removed to allow visualization of the bundled sutures 1102 housed in the recess channel 1104 of the conical anchor 704.

[0125] The ends of the suture bundle 1102 may be connected to two needles 804 at opposite ends. As shown, the two suture bundles 1102 may have four needles 804. The suture bundles 1104 may be arranged on opposite sides of each other separated by the advancement shaft or may be separated. The needles 804 on both sides may be simultaneously engaged with the recess channels 1104 that feed out both suture bundles 1102. The recess channels 1104 may rotate for two different bundled sutures 1102 while the needles 804 are being pulled into the catheter shaft 702.

[0126] The recess channel 1104 may be shaped to allow the feeding and release of the suture bundle 1102. In one example, the sutures of the suture bundle 1102 may be wound within a recess channel 1104 that can be held taut within the anchor 704. When the needle attached to the suture bundle 1102 is pulled, the suture bundle 1102 can be fed out. This amount may be, for example, 2 - 3 cm.

[0127] Referring to FIG. 12, it is an isometric view of the distal end of an exemplary vascular device 200, showing the snare 1202 advanced from the body of the vascular device 200 according to one aspect of the present disclosure. The four snares 1202 may be used to grasp, hook, or loop a suture bundle having a suture for the snare at the opposite end. Small perforations may be made for the snare 1202 to pass through the tissue, or the snare 1202 itself may have a tip that can perforate the tissue. The snare 1202 may pass through the catheter shaft 702 at the proximal end and be disposed outside the lumen described above. When the needle 804 is captured, the snare 1202 may be pulled through the catheter shaft 702.

[0128] In one example, the recesses 1204 disposed within the needle 804 may be used by the snare 1202. These recesses 1204 may be angled towards 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 connected to the recess 1204.

[0129] To simultaneously push through multiple snares 1202, a mechanism may be used at the proximal end of the catheter shaft 702. The snares 1202 may grasp the needle 804 through tissue and then pull simultaneously. In an alternative embodiment, the snares 1202 may be individually pushed into the shaft 702 to capture or snag a single needle 804 at a time through its recess 1204. In one embodiment, two snares 1202 may work in conjunction to pull two corresponding needles 804 through the shaft 702. The two needles 804 may be connected to opposite sides of the suture bundle. The needles 804 may be detached from the suture after being pulled into the shaft 702.

[0130] The snares 1202 may be made of various materials. For example, the snares 1202 may be made of radiopaque platinum coils and tips to enhance visibility. The snares 1202 may include a helical loop design that achieves a long reach while having a profile smaller than a right-angle loop. Durable cobalt-chromium loops may increase strength and retain shape. The snares 1202 may have loops of different sizes, such as 1 mm, 2 mm, 3 mm loop diameters, for clinical versatility.

[0131] FIG. 13 is an isometric view of the distal end of an exemplary vascular device 200 after four suture needles 804 and suture ends have been passed through, snared, and pulled through a length portion of the device 200 in accordance with one aspect of the present disclosure. The catheter shaft 702 of the vascular device 200 may receive the needles 804 after being pulled by the snares. The suture 1302 may be fed out of the recess channel and tensioned from the suture bundled by the pulling of the needles 804 connected to opposite ends.

[0132] In one embodiment, the suture 1302 may be made of a finely woven nylon material. Other materials such as polypropylene, silk, polyester, etc. can be used, but are not limited thereto. The suture 1302 may be made of a material that is strong but bendable. The suture 1302 may be in a "U" shape or a "C" shape. The suture 1302 may be immersed in a sterilized mineral oil immediately before its use. The ends of the suture 1302 can be easily sutured to the edge of the incision in the atrial septum. The suture may be made of a high-temperature resistant material so as not to be damaged even when in contact with the cutting instrument.

[0133] FIG. 14 is an isometric view of the distal end of an exemplary vascular device 200 after the suture 1302 has been fully drawn through the length portion of the device 200 and pulled against the tissue, according to one aspect of the present disclosure. The suture 1302 may be fully drawn out from the recess of the anchor 704. The ends of the suture 1302 may be available to the user through the proximal end of the catheter shaft 702 of the vascular device 200. During the surgery, the suture may be loosened or tightened according to the user's needs at a specific time.

[0134] Referring now to FIG. 15, an isometric view of the distal end of the vascular device 200 is provided after the cutting instrument 1500 has been partially advanced and the cutting element 1506 is visible, according to one aspect of the present disclosure. When the suture 1302 is pulled against the tissue so as not to be cut, the anchor 704 having a conical shape may be further advanced into the left atrium through the advancing shaft 802. The shaft 802 may extend through the catheter shaft 702 of the vascular device 200 towards and through the puncture portion of the atrial septum. The advancing shaft 802 may extend through the proximal end of the vascular device 200.

[0135] By advancing the shaft 802 through the tissue of the atrial septum, a second rectangular expandable cutting device 1500 can be fed through the rectangular channel of the catheter shaft 702. The cutting device 1500 may include an expansion actuating shaft 1502 that can expand and contract on the advancing shaft 802 for the anchor 704. That is, the expansion actuating shaft 1502 can slide over the advancing shaft 802 of the anchor 704.

[0136] The expansion actuating shaft 1502 may be advanced through the puncture portion and disposed within the left atrium to expand the cutting device 1500. When the expansion actuating shaft 1502 is pushed forward, the cutting device 1500 having the linkage system 1504 is exposed. The distal end of the cutting device 1500 may be temporarily locked to the upper portion of the advancing shaft 802 of the anchor 704, while the proximal end of the cutting device 1500 may be connected to the lower portion of the expansion actuating shaft 1502.

[0137] The linkage system 1504 can bend outward into an arch and expand the cutting element 1506 to a length much larger than the diameter of the vascular device 200 when the anchor 704 is retracted and the expansion actuating shaft 1502 is held in place. The linkage system 1504 may bend at the symmetry point 1508 when the advancing shaft 802 is retracted. As shown, the cutting element 1506 is disposed behind the anchor 704 facing the catheter shaft 702. In operation, the linkage system 1504 can eliminate the possibility of cutting the suture 1302 that is parallel when the cutting element 1506 is expanded.

[0138] FIG. 16 is an isometric view of the distal end of the vascular device 200 with the incision instrument 1500 in an expanded state, according to one aspect of the present disclosure. The anchor 704 is, in one configuration, retracted covering the advance / retreat shaft. When this is done, the upper part of the incision instrument 1500 is held and lowered together with the anchor 704, and the expansion operation shaft 1502 holds the lower part of the incision instrument 1500. As a result, the incision instrument 1500 in the linkage system 1504 may be bent, and the incision element 1506 may be exposed. The incision element 1506 may be perpendicular to the shaft such that the incision element 1506 expands beyond the diameter of the catheter shaft 702.

[0139] Parallel alignment of the incision element 1506 with respect to the suture 1302 may be made so that the incision element 1506 does not inadvertently cut the suture 1302. By tearing the tissue and pulling it back into the left atrium through the incision element 1506, a plurality of incisions or incisions may be formed by the incision element 1506. Depending on the number of incisions, this process may be repeated. Therefore, the number and position of the sutures and needles may vary depending on the size and number of the incisions made.

[0140] When completed, the incision element 1506 may be retracted by advancing the anchor 704. By this advancement, the linkage system 1504 may collapse and contract into a narrow channel where the incision element 1506 is not exposed. The lock connecting the upper part of the advance / retreat shaft and the incision instrument 1500 may be removed. Thereafter, the incision instrument 1500 may be pulled through the catheter shaft 702 without moving the anchor 704. After removing the incision instrument 1500, the vascular device may be removed leaving the suture 1302 as it is.

[0141] When the anchor 704 of the vascular device 200 is being used in the left atrium, other techniques or devices may be used to expand and collapse the incision element 1506 so that the tissue is not inadvertently incised. The linkage system 1504 that enables the use of the incision element 1506 may be in various forms and is not necessarily limited to that shown in this embodiment. For example, the linkage system 1504 may be entirely present on the expansion operating shaft 1502, whereby the proximal mechanism may be used to expand and collapse the incision element 1506 without the need to retract the anchor 704. For this, another knob, pull wire, etc. may be used to expand and fold the incision element 1506. Other variations may exist, and those variations are also within the scope of the present disclosure.

[0142] Referring now to FIG. 17, an isometric view of an exemplary vascular device 200 arranged to incise tissue 900 according to one aspect of the present disclosure is provided. The vascular device 200 may be angled by a predetermined amount to enable more orthogonal contact with the tissue 900. This may facilitate a more stable interface between the tissue 900 and the catheter shaft 702.

[0143] The distal end of the catheter shaft 702 may be angled to conform to the tissue 900. The shaft 702 typically does not pass through the slit 1702 created by the first perforation or incision element 1506. However, the anchor 704 of the vascular device 200 may extend through the puncture into the left atrium. The linkage system 1504 may be expanded, and the incision element 1506, which may be in the form of a blade, may be used to incise the slit 1702 through the tissue 900. The length of the slit 1702 may be controlled by how much the linkage system 1504 is expanded. The vascular device 200 may be rotated to create other slits 1702 or combinations of slits 1702.

[0144] In operation, the anchor 704 of the vascular device 200 may advance through the initial puncture site. The needle may extend toward the catheter shaft 702. Thereafter, the suture may be delivered from the back end toward the tissue 900 before any incision 1702 is formed. And after the incision 1702 and treatment instrument are used, the suture may be managed.

[0145] FIG. 18 is an isometric view of a suture 1302 that would be inserted into the tissue 900 according to one aspect of the present disclosure. The two sutures 1302 may correspond to those fed out from the recesses of the anchors. After removal of the vascular device, the two lengths of suture 1302 may remain in a fixed position behind the atrial wall extending from the left atrium.

[0146] Also, the guidewire previously used with the vascular device may be left in place. The guidewire may be used by a larger-diameter device such as a treatment instrument, move over the guidewire, easily access the left atrium through the slit, and run adjacent to the previously placed suture. When the larger-diameter device is removed, the free ends of the sutures 1302 may be tied and pushed toward the tissue to create a closing force. Thereby, the size of the cuts and holes in the tissue made using the larger-diameter device can be reduced. Advantageously, this can prevent or minimize the interventricular hemodynamic communication, and the user can leave a simple knot in the atrial septum. Generally, the hole may close in the short term. In the long term, it can be used to enable access to the left atrium when the patient requires another catheter-based treatment or procedure.

[0147] FIG. 19 is an isometric view of an incision after tissue 900 has engaged with suture 1302, according to one aspect of the present disclosure. A close-up of tissue 900 after knot 1902 has been tied is shown. The slit created by the incision instrument is tightened centrally by knot 1902, which may reduce or eliminate the hemodynamic flow and the amount of interventricular communication. For illustrative purposes, knot 1902 may be represented by a simple "X" configuration. Alternatively, knot 1902 may be one of several different types of surgical knots that can tie and push down a vascular device via a remote location.

[0148] In one embodiment, knot 1902 may be formed with a knot pusher having a pusher rod fitted with an incision member in the form of a distal port and a sharp outer sheath, and advanced. Knot 1902 may hold an associated patch at a location where excess wire can be cut by the shearing action of the pusher rod distal port and the distal sharpened portion of the incision member. Excess wire and other elements may be removed from the catheter.

[0100] Known knot pushers in the art include the Edwards ThruPort knot pusher, Medline Endoscopic Pushers, and Laparoscopic Knot Pushers by Cooper Surgical.

[0101] Arthrex offers several options. The Single-Hole Knot Pusher may easily advance a sliding knot or a half hitch. This closed-end knot pusher has an improved handle to achieve an ergonomic feel. Also, the distal end is improved to easily advance a slip knot or a half hitch. The sixth finger is designed to tie the surgeon's knot and allow the surgeon to initially apply tension slowly and advance subsequent throws while maintaining the tension. The CrabClaw incorporates an opening jaw so that it can capture the suture within the joint.

[0149] A simple incision with closure was previously described. Looking at FIGS. 20A-L, various exemplary cut patterns are provided that can be made from at least one incision instrument that rotates and can be used a single or multiple times and can be made using a vascular device in the atrial septum. In embodiments, various incision shapes can be formed in the atrial septum. These shapes may be formed with multiple incision arms or, like the above-described incision instrument, by rotating one incision arm and using it multiple times. The length of the incision can be controlled by the user by operating an adjustable incision instrument. The incision can take many different shapes commonly used to facilitate both the passage of a treatment device and the closure of the tissue plane after treatment.

[0150] Referring to FIGS. 20A-20C, it can be controlled by the nature of the crimping of the tissue edges, the position of the anchors or sutures 2002 and 2004. To increase overlap or tissue crimping, the first distance 2006 between sutures 2002 and 2004 may be increased to the second distance 2010. As another method or technique, suture positions or sutures 2012 may be added in various intersecting paths. The incision 2008 may be in the middle of the sutures 2002, 2004, 2012.

[0151] As shown in FIGS. 20D - F, incision 2008 can take the form of many patterns, such as, for example, a straight cut, a V - cut 2020, a zigzag 2022, or a crescent arc 2024. These incisions can then be combined with other shapes that result in a plurality of flaps 2030, 2032, or 2034 of tissue as shown in FIGS. 20J - L. Various configurations may be advantageous depending on the shape and size of the device necessary to pass through, or the type and amount of closure desired after the procedure. Some incision shapes, such as those in FIGS. 20D - F, may promote an overlap 2026 of tissue planes at closure due to the shape of the incision and the tension of the tissue before and during healing. The overlap can greatly assist in the healing of the tissue ends. That is, shown in FIGS. 20G - I are overlaps 2026 of tissue planes from different incision shapes 2020, 2022, 2024.

[0152] The embodiments described herein manage variables for controlling the closure of incision 2008. The tissue ends may be managed by placing control members before forming incision 2008. For example, as shown above, the tissue may be secured by having sutures 2002, 2004, 2012 in place before incision 2008 is formed by an incision instrument. In one embodiment, the control function may be applied after incision 2008 is formed.

[0153] To manage the amount of tissue overlap, the crimping pressure, and the residual flow after closure of the closer, the end - to - end crimping of the tissue ends can be controlled. This control may be performed by controlling the position of the suture line relative to the incision. As an example, as the distance of the suture line from the incision end increases, there may be more bunching of tissue or more tissue overlap. Increasing the number of tissue anchors and / or suture passage positions can increase the amount of tissue crimping along the length of the incision. The magnitude of the tension and pressure applied to the suture line may also further affect the amount of closure of incision 2008. These mechanisms may be managed in real - time and monitored by echoflow monitoring and / or visualization by fluoroscopy.

[0154] In one embodiment, a mechanism that does not leave a long-term implant in the patient may be used. This mechanism may be designed to either seal the tissue, heal the tissue in a sealed state, or heal the tissue in a partially sealed state. By changing the application of the mechanism, the hemostasis rate may be adjusted. This mechanism may be designed to fix the tissue through various time points. These time points may correlate with various tissue healing cascade points such as the time of tissue coagulation, adhesion, endothelialization, scarring, etc.

[0155] An absorbent body that facilitates closure and is absorbed by the body over time may be left. In one embodiment, the absorbent body may be removed from the body at a later time. The closure device may be fully or partially engaged with the tissue plane near the incision 2008 before the incision 2008 is formed. In another embodiment, applying a closure device that is fully or partially engaged with the tissue plane may be near the incision 2008 after the incision is formed. In one embodiment, the closure mechanism may be fully or partially engaged and applied within the tissue plane near the incision 2008 after the incision 2008 and the treatment device are removed from the incision 2008.

[0156] The incision device described herein may be used to control the state of the end of the tissue based on the method of forming an incision in the tissue. Without limitation, methods of forming an incision may include sharp blades made of durable materials such as metals and ceramics, electrosurgical techniques, RF energy, plasma jet vaporization, ultrasonic, high voltage vaporization, controlled expansion, heat, and cold air, etc. By using such various incision methods, the state of the cells at the end of the incision surface can be controlled and the healing cascade can be optimized.

[0157] FIG. 21 is an isometric view of an exemplary cut pattern 2106 of an incision for promoting crimping of tissue edges according to one aspect of the present disclosure. The cut pattern 2106 may be defined by a first end 2102 and a second end 2104. Also, the cut pattern 2106 may be formed in the tissue 900. The inner edge 2108 is spaced from the outer edge 2110. This may be a cut pattern 2106 that is a combination of linear and arcuate incisions to promote overlap and crimping of tissue edges.

[0158] FIG. 22 is an isometric view of an exemplary cut pattern of an incision for promoting crimping of tissue edges, while applying a slight tension and controlling the tissue edge in the tensioned state to overlap the edges. This demonstrates an yield over-lap 2202 between the inner edge 2108 and the outer edge 2110 in the tissue 900 caused by the cut pattern between the first end 2102 and the second end 2104.

[0159] FIG. 23 is an isometric view showing a cut pattern of an incision for promoting crimping of tissue edges and a helical anchor 2300 for controlling the tissue edges according to one aspect of the present disclosure. Tension may be applied in the direction of the ends 2102, 2104 of the incision. The inner edge 2108 and the outer edge 2110 having the yield over-lap 2202 in the tissue 900 may be fixed by the helical anchor 2300 or the like.

[0160] Above, the first embodiment of the blood vessel device has been described. FIGS. 24 to 38 illustrate a second embodiment of the blood vessel device 2400 with additional exemplary incisions. It will be understood from the present disclosure that the components having these embodiments can be exchanged, added, or deleted based on a reasonable configuration. New embodiments using these modifications are within the scope of the present disclosure.

[0161] Turning to FIG. 24, an isometric view of an exemplary expandable high-frequency (RF) cutting instrument 2410 having four expandable members 2416 according to one aspect of the present disclosure is provided. The cutting instrument 2410 may be between the catheter shaft and the distal anchor as described above. Four cutting members 2414 are shown, but fewer or more may be used with each cutting member 2412 being equidistant from each other.

[0162] The cutting instrument 2410 may be expandable and contractible through a linkage system similar to that described above. The cutting instrument 2410 may collapse as it advances through the initial puncture and expand after passing through the tissue. The cutting instrument 2410 may have four expandable members 2414 connected to four cutting members 2412. The cutting members 2412 may be provided at the proximal end of the cutting instrument 2410 such that the cutting instrument is pulled back towards the tissue to form an incision.

[0163] The cutting members 2412 may extend radially from the center of the cutting instrument 2410. The width of the cutting member may vary to change the incision length based on the French size of the delivery catheter. The cutting instrument 2410 may include a tip piercing device 2416 at the distal end of the cutting instrument 2410. This may be used to pierce the tissue. The cutting members 2412 and the tip piercing device 2416 may use mechanical energy or electrical energy. The mechanical or electrical energy may be obtained from at least one of a blade, ceramic, electrosurgical technology, RF, plasma jet vaporization, ultrasound, high voltage vaporization, controlled expansion, heat, and cold air. In one example, both the cutting members 2412 and the tip piercing device 2416 may use mechanical energy. Alternatively, both may use electrical energy. In yet another variation, the cutting members 2412 and the tip piercing device 2416 may use different types of energy. The cutting instrument 2410, along with its members 2412 and arms, may expand radially in a controlled manner or plane to minimize or prevent the cutting instrument 2410 from inadvertently cutting or adversely affecting previously placed closure sutures.

[0164] Figure 25 is an isometric view of an exemplary vascular device 2400 comprising an expandable incision device 2410 having a tip for piercing tissue 900, in accordance with one aspect of the present disclosure. The tip piercing device 2416 may be coupled to the incision device 2410 and pushed through the tissue 900 to form a perforation within the tissue 900. The puncturing may be performed via a mechanism at the proximal end so that a physician can control the vascular device 2400. The incision device 2410 may be in a retracted state prior to advancing through the tissue 900.

[0165] Without limitation, the catheter shaft 2504, or delivery catheter, may house the incision device 2410 and the anchor mechanism 2502. The anchor mechanism 2502 may be equidistant from the center of the catheter shaft 2504. Although four anchor mechanisms 2502 are shown, there may be fewer or more depending on the closure strategy for the incision formed in the tissue 900.

[0166] Although not shown, the vascular device 2400 may include a visualization tool for determining the position of the device 2400 within a patient. In one embodiment, sensors may be affixed to the device 2400 to determine the position and orientation of the catheter. Alternatively and / or additionally, an independent tracking system may be based on ultrasound, impedance or fluoroscopic tracking. In the case of impedance, the potential generated by an electric field generator may be detected by existing electrodes. In the case of fluoroscopy, the position of the electrodes may be detected by an image processing scheme that identifies and tracks electrodes and / or opaque markers located on the device 2400.

[0167] FIG. 26 is an isometric view of an exemplary expandable incision device 2410 disposed beyond tissue 900 and an exemplary vascular device 2400 having the same. Note that the incision device 2410 in the retracted state may be pushed through after puncturing the tissue 900. The incision device 2410 may be delivered by an advancement shaft that may be controlled at the proximal end, while the catheter shaft 2504 does not flow therethrough.

[0168] After the incision device 2410 is disposed in the left atrium, the incision device 2410 may be expanded. The expandable member 2414 may be expanded from its center to radially expand to a diameter larger than the diameter of the device 2400 itself.

[0169] The anchor mechanism 2502 within the catheter shaft 2504 may be used to push the delivery mechanism described below. The anchor mechanism 2502 may be disposed within the catheter shaft 2504 and may be enclosed within the lumen. The anchor mechanism 2502 may surround the focused incision device 2410 and may be equidistant from each other.

[0170] Referring to FIG. 27, it is an isometric view of an exemplary vascular device 2400 having an exemplary expandable incision device 2410 that forms an incision within the tissue 900 according to one aspect of the present disclosure. After the expandable member 2414 is expanded, the advancement shaft may be retracted toward the catheter shaft 2504 together with the tip perforation device 2416 to form an incision in the tissue 900. These incisions may be formed on the back of the left atrium. The incision device 2410 may be extended, rotated, and then retracted to make additional incisions in the tissue 900. During this time, the anchor mechanism 2502 may be held in a stationary state.

[0171] FIG. 28 is an isometric view of an exemplary vascular device 2400 having an exemplary expandable incision device 2410 for advancing an anchor mechanism 2502 according to one aspect of the present disclosure. When the anchor mechanism 2502 is pushed through the catheter shaft 2504, it may extend through the tissue 900 to the opposite side, i.e., the left atrium. The anchor mechanism 2502 may be coupled to a delivery mechanism 2802 that can be transferred through the tissue 900. The delivery mechanism 2802 may have a tissue puncture point.

[0172] Four delivery mechanisms 2802 coupled to four anchor mechanisms 2502 may pierce the tissue 900. There may be fewer or more combination structures within the vascular device 2400. The delivery mechanism 2802 may use the same energy as the expandable member 2414 and the tip piercing device 2416. That is, mechanical energy and / or electrical energy may be used in combination.

[0173] FIG. 29 is an isometric view of an exemplary vascular device 2400 having an exemplary expandable incision device 2410 with a push anchor 2902 further inserted to advance the anchor mechanism 2502 according to one aspect of the present disclosure. The anchor mechanism 2502 may advance the delivery mechanism 2802 within the catheter shaft 2504 through and beyond the tissue 900, i.e., into the left atrium. Thereafter, the push anchor 2902 may be deployed by the delivery mechanism 2802. The push anchor 2902 may be used to fix the tissue 900 and its surroundings. The anchor 2902 may be made of PLGA, PLLA, nylon, polyester, PEEK, or other biocompatible materials. Note that the incision device 2410 can be advanced into the tissue 900 after the push anchor 2902 is set in place.

[0174] Other anchors may be used to fix the tissue 900. For example, a tissue anchor line may be utilized. Although not particularly limited, these may include suture threads, toggles, helical structures, grasping devices, reversing clips, expanding structures, mesh structures, stent-like structures, patch structures, clips, expandable valves, and suture knot configurations.

[0175] FIG. 30 is an isometric view of an exemplary vascular device 2400 with the delivery mechanism 2802 removed, according to one aspect of the present disclosure. The anchor mechanism 2502 coupled to the delivery mechanism 2802 may be pulled at the proximal end of the catheter shaft 2504. This may pull the delivery mechanism 2802 from the left atrium 302 into the right atrium 106. The incision device 2410 having the expandable member 2414 and the tip perforation device 2416 may still be inserted into the patient's left atrium. The anchor 2902 may be left with respect to the tissue 900. They may be embedded therein.

[0176] FIG. 31 is an isometric view of an exemplary incision device 2410 with the tissue anchor 2902 left with respect to the tissue 900 and removed from the tissue, according to one aspect of the present disclosure. The incision device 2410 may be removed through the catheter shaft 2504 of the vascular device 2400. At this time, the catheter shaft 2504 may still be disposed in the patient's right atrium.

[0177] Referring to FIG. 32, an isometric view of an exemplary toggle 3202 within the tissue 900, according to one aspect of the present disclosure, is provided. The toggle 3202 may be pushed or advanced longitudinally through the tissue from the right atrium to the left atrium. The toggle 3202 may be shifted horizontally and fixed to the septum to fix the tissue. The toggle 3202 may be made of a material similar to that of the anchor and may be biodegradable. This closure device or other closure devices disclosed herein will exist in a size and location that will not interfere with another access procedure in the future.

[0178] Multiple cutting instruments have been described above. These instruments and the instruments described later may use mechanical energy or RF energy. When using electrical energy, the amount of exposed metal can be minimized by an insulator so that the exposed metal exists only in the desired tissue cutting area of the tool. The less the amount of metal exposure, the higher the cutting effect on the tissue can be. Advantageously, less power can be used. To obtain the best cutting effect, the surgeon may confirm that the cutting area is in good mechanical contact with the target tissue.

[0179] The first septal puncture site and the septal incision may be performed using separate energies. For example, using electrical energy, the first puncture may be performed in the first circuit and a larger incision may be made in the second circuit. When the first puncture is performed separately from the incision, the surgeon may rotate the cutting instrument and align the cutting arm in the direction of the incision. When making a second incision after the first puncture by advancing the cutting instrument from the right atrium to the left atrium, it is considered beneficial that the cutting areas of the first puncture and the second large incision overlap and there is no possibility that a part of the tissue is not incised.

[0180] If there are symmetric cutting arms on both sides of the central puncture element, the center of the entire incision may be at the intended puncture site and may not shift in one direction. This is important when it is necessary to keep a certain distance from the target structure in subsequent procedures.

[0181] The following cutting instruments may form a continuous incision from the central puncture site to the end of the incision. These tools are intended to cut from the center to the end. The adjustability or expandability of the cutting instrument can be realized using the pull wire / ring mechanism described above, where pulling the wire compresses the cutting instrument and makes it bow outward. It may also be done using a spring or a forming tool made of a shape memory alloy.

[0182] Turning now to FIG. 33, an isometric view of an exemplary incision device 3300 having a non-invasive tip 3304 deployed from an exemplary vascular device according to one aspect of the present disclosure is provided. The incision device 3300 may be deployed from the distal end of a tubular member 3302 from which an electrical insulator has been selectively removed. The incision device 3300 may be of a fixed size or may be adjustable by mechanical design.

[0183] The design may incorporate a non-invasive tip 3304 that can be used to find the fossa ovalis or other desired target location. It also has incision surfaces 3306 that may extend symmetrically on both sides of the non-invasive tip 3304. In these types of embodiments, the initial septum puncture and slit formation may be performed in one operation with the same continuous incision surface 3306, i.e., they may be part of the same circuit for supplying energy, or they may be on separate circuits. If the puncture / incision energy is RF, microwave, or other electrical energy, the insulator may be strategically removed from the metal structure. The amount of insulator removed, or the amount of metal exposed, may be varied to optimize performance. For example, it may completely surround the perimeter of the incision surface arm or may exist as a thin line along the length of the incision surface arm. The goal may be to energize the incision surface and make good contact with the tissue while minimizing direct contact with the blood pool.

[0184] FIG. 34 is an isometric view of an exemplary incision device 3400 having a slit 3404 within a sheath 3402 deployed from an exemplary vascular device according to one aspect of the present disclosure. An incision tool incorporating one incision arm may radiate through the slit 3404 of the needle-like sheath 3402 described below. In this embodiment, since there is only one incision arm, the size of the arm may be fixed or adjusted by a mechanism using, for example, a pull wire, a spring, etc. The distal portion 3406 of the incision device 3400 may be used for the initial puncture. Unlike the above-described embodiments, when electrical energy is used to incise tissue, the initial septum puncture site and slit formation are part of separate parallel circuits.

[0185] FIG. 35 is a side view of an exemplary incision instrument 3400 having an incision element 3502 extending from a slit 3404 within a sheath 3402, according to one aspect of the present disclosure. The expandable incision arm 3504 is part of a pull wire that can travel along a length portion of the catheter, and the puncture needle surface is another part.

[0186] In one embodiment, the first puncture needle may be fully insulated and have metal exposed only in the distal region for supplying energy to tissue. The expandable incision element 3502 in the form of a radially extending arm may be mostly insulated with a thin line of exposed metal running along the incision surface (or any number of patterns for exposing metal with a minimal surface area). It may be possible and more desirable to energize these two different incision surfaces simultaneously with one switch or at different times during the procedure through different switches at the handle end. There is an advantage that an anchor point can be created in the tissue simply by first puncturing with the needle. Once this first puncture is made, the surgeon may rotate the incision instrument 3400 until the expandable incision element 3502 is aligned at the desired location along the length of the incision.

[0187] FIG. 36 is an isometric view of the distal end of an exemplary incision instrument 3400, according to one aspect of the present disclosure. The expandable incision arm 3504 for the incision element 3502 may be a wire that travels along a length portion of the catheter. The puncture needle 3602 may be part of another mechanism for actuation. The incision element 3502 may have metal exposed circumferentially or may be mostly insulated with only a thin linear metal exposed along the incision surface. During the surgery, the expandable incision arm 3504 may be pushed up and down to change the shape of the incision element 3502.

[0188] The initial puncture needle 3602 may be fully insulated, with metal for supplying energy to tissue exposed only in the distal region. In one embodiment, the incision instrument 3400 may have two different incision surfaces that can be energized simultaneously with one switch or at different times during the procedure through different switches at the handle end. The advantage of first puncturing with the needle 3602 is that it can create an anchor point within the tissue. Once the initial puncture is made, the surgeon may rotate the instrument until the expandable incision arm aligns the length portion of the incision where desired.

[0189] Further, when the expandable incision arm 3504 is pulled in the proximal direction, the incision element 3502 may be retracted inwardly. The incision element 3502 may be retracted toward the center of the incision instrument 3400. The energy applied to the incision element 3502 may be removed to prevent inadvertent incisions.

[0190] FIG. 37 is a cross-sectional explanatory view of an incision instrument 3400 according to one aspect of the present disclosure. A schematic diagram is shown of how the incision arms of the embodiment are made to optimize the cutting performance of the tool and enable minimizing the required power input by having exposed metal 3702 in specific regions, and the thinnest insulator may be used to ensure better tissue contact with the exposed metal surface. Also provided is a sheath 3402 with no exposed metal using an insulator 3704. In this embodiment, the incision element, i.e., the incision arm, is not used. Rather, cutting may also be done using RF power.

[0191] FIGS. 38A - E are schematic diagrams showing how an incision instrument according to one aspect of the present disclosure may be used to optimize cutting performance and minimize power input. Various incision shapes that may be formed by embodiments passing through the atrial septum are shown. These shapes may be formed with multiple cutting arms or one cutting arm may be rotated and used multiple times.

[0192] Figures 39 to 53 illustrate a third embodiment having a delivery sheath and a helical anchor for attaching to tissue. Components described below may be attached to the catheter shaft. The shaft interior may have several different lumens and channels for these components. In one embodiment, separate tools may be used for each component. These tools may follow along an installed guide wire. The following shows techniques and / or devices for large-bore transseptal access and subsequent atrial re-access.

[0193] Turning to FIG. 39, an isometric view of an exemplary tissue 900 intersected using an exemplary guide wire 102 according to one aspect of the present disclosure is provided. The procedure may begin by first piercing or intersecting the guide wire 102 with the tissue 900. The guide wire 102 may be routed through a vascular introduction sheath that ascends in the cranial direction in the inferior vena cava to reach the right atrium. The guide wire 102 may be placed to guide a therapeutic or diagnostic catheter into the cardiac region.

[0194] FIG. 40 is an isometric view of a suture anchor 4002 within a delivery sheath 4004 according to one aspect of the present disclosure. The delivery sheath 4004 may accommodate other components in addition to the tissue anchor 4002. Using the guide wire, the delivery sheath 4004 may be directed towards the tissue 900 of the atrial septum.

[0195] FIG. 41 is an isometric view of an exemplary suture anchor 4002 within a delivery sheath 4004 attempting to penetrate the tissue 900 according to one aspect of the present disclosure. The suture anchor 4002 may be placed at a first puncture point 4102 and a second puncture point 4104 that may be guided via the guide wire 102. It may then be inserted into the tissue 900.

[0196] Referring to FIG. 42, an isometric view of an exemplary suture anchor 4002 within a delivery sheath 4004 that engages or penetrates tissue 900 according to one aspect of the present disclosure is provided. The suture anchor 4002 within the delivery sheath 4004 may engage or penetrate tissue 900 in the vicinity of the guidewire 102.

[0197] FIG. 43 is an isometric view of an exemplary suture anchor 4002 within a delivery sheath 4004 that engages tissue 900 with a suture control line 4302 attached thereto according to one aspect of the present disclosure. The suture control line 4302 can be used to hold a suture at a predetermined position within tissue 900 in the vicinity of the guidewire 102 during the surgery. The delivery sheath has been removed and the suture control line 4302 is exposed.

[0198] FIG. 44 is an isometric view of an exemplary cutting instrument 4400 in a state of being housed within a sheath according to one aspect of the present disclosure. The cutting instrument 4400 may be housed within the sheath 4402. The cutting instrument 4400 may be routed around the guidewire, i.e., its guidance may be performed with respect to the tissue based on the guidewire.

[0199] Turning to FIG. 45, it is an isometric view of an exemplary cutting instrument 4400 at a position where the sheath has been removed according to one aspect of the present disclosure. The cutting instrument 4400 may extend outside the sheath 4402. This may be performed at the proximal end by an advancement mechanism through the sheath 4402.

[0200] FIG. 46 is an isometric view of an exemplary cutting instrument 4400 expanded at a position where the sheath has been removed according to one aspect of the present disclosure. After the cutting instrument 4400 extends outside the sheath 4402, a spring load may be applied so as to expand symmetrically left and right. Also, the cutting instrument 4400 may be expanded by a mechanism such as a pull wire. By expanding the cutting instrument 4400, tissue incision can be facilitated.

[0201] FIG. 47 is an isometric view of an exemplary incision instrument 4400 that forms an incision or cut in tissue 900, according to one aspect of the present disclosure. Suture anchors 4002 within the delivery sheath may be used to hold the tissue 900 in place while allowing the incision instrument 4400 to be guided. The incision instrument 4400 may form an incision between two suture anchors 4002 of the delivery sheath.

[0202] Referring to FIG. 48, an isometric view of an exemplary incision 4800 within tissue 900 through which a guide wire 102 passes, according to one aspect of the present disclosure, is provided. With the incision instrument removed, two suture anchors 4002 connected to the suture control line 4302 remain with the guide wire 102.

[0203] FIG. 49 is an isometric view of a state in which an exemplary treatment instrument 4900 is being advanced through an incision in tissue 900 over a guide wire, according to one aspect of the present disclosure. The treatment instrument 4900 may be advanced through the guide wire and through the incision in the tissue 900. The treatment instrument 4900 may be disposed between two suture anchors 4002 connected to the suture control line 4302.

[0204] FIG. 50 is an isometric view of an exemplary tissue anchor lock 5000 having a helical barb 5002, according to one aspect of the present disclosure. The lock 5000 having the helical barb 5002 may be embedded in tissue as shown below to close the incision.

[0205] Turning to FIG. 51, an isometric view of an exemplary tissue anchor lock 5000 having helical barbs engaged within tissue 900 passed over a suture control line 4302, according to one aspect of the present disclosure, is shown. In this technique, the tissue 900 having the incision 4800 may be twisted with the tissue anchor lock 5000 using the helical barbs. Thereby, the suture, the anchor, and the tissue 900 may be fixed to each other.

[0206] FIG. 52 is an isometric view of an exemplary tissue anchor lock 5000 having a helical barb engaged within tissue and a control line 4302 trimmed to the level of the anchor, passed over a suture control line, in accordance with one aspect of the present disclosure. The excess suture control line 4302 may be trimmed via another cutting instrument guided into the tissue using a guide wire. The incision 4800 may be closed with the lock 5000 having a minimal amount of control line 4302 attached thereto.

[0207] FIG. 53 is an isometric view from the other side of the tissue 900 of an exemplary tissue anchor lock 5000 having a helical barb 5002 engaged with the tissue 900, in accordance with one aspect of the present disclosure. The lock 5000 may be interposed between the tissues 900 and allowed to heal and endothelialize with the tissues 900, or be absorbed or dissolved. This figure shows the opposite side of the atrial wall shown in FIG. 52. The lock 5000 may be twisted to seal the incision after grasping or hooking the tissue 900.

[0208] A plurality of techniques for closing the incision to allow reaccess have been described above. Further, FIGS. 54 - 69 provide a fourth embodiment of disposing a plurality of plugs made of a biodegradable material secured together with knots to close the incision while allowing reaccess at a later time. Although two plugs may be used below, the number passed into the tissue for site fixation may be less than or greater than that. Without limitation, the plugs may be constructed from a bioabsorbable, biodegradable material including sugars, salts, collagen, PLGA, PLLA, other absorbable polymers, magnesium, or other materials. The plugs may be composed of a combination of materials to facilitate different structural properties. Without limitation, some of these materials may be conventional implant materials such as metals or polymers including stainless steel, nitinol, cobalt chrome, PEEK, HDPE, etc.

[0209] Turning to FIG. 54, it is an isometric view of an exemplary patch 5402 made of a biocompatible or bioabsorbable material according to one aspect of the present disclosure. The patch 5402 made of a biocompatible material or a bioabsorbable material may be configured to generally interweave the control lines 5404. The patch 5402 may be a single piece of material that disperses the control lines 5404 between the patches 5402 to make it elongated and tied or fastened at the ends of the patches 5402. The control lines 5404 may be interspersed between the openings in the patch 5402.

[0210] FIG. 55 is an isometric view of an exemplary cannula 5500 for suturing heart tissue 900 according to one aspect of the present disclosure. The cannula 5500 may have a sharp distal end, but preferably uses RF energy to penetrate the tissue 900. The cannula 5500 may use RF at a distal end having an insulator covering a tubular structure. The tubular structure may allow a mechanism such as a patch to flow 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 firmly set in a predetermined position. Different variations of the cannula 500 exist, and the techniques described herein are not limited to the cannula 500 shown.

[0211] FIG. 56 is an isometric view of an exemplary cannula 5500 for suturing heart tissue 900 according to one aspect of the present disclosure and an exemplary patch 5402 made of a biocompatible or bioabsorbable material advanced through the cannula 5500. The cannula 5500 may penetrate the tissue 900 with a circular incision. Generally, the incision may be small enough that the compressed patch can occlude or fill the incision and provide sufficient crimping to apply tension to the tissue for subsequent closure. Other shapes of the incision may be used depending on the cross-section of the cannula 5500.

[0212] Referring to FIG. 57, an isometric view is provided of an exemplary cannula 5500 for suturing cardiac tissue 900 and an exemplary project 5402 made of a biocompatible or bioabsorbable material advanced out of the cannula 5500. The advancement member 5702 may be disposed within the cannula 5500 from the proximal end to push the project 5402 having the control wire 5404 into the left atrium. In one embodiment, the proximal end of the project 5402 is connected to the distal end of the advancement member 5702 via the control wire 5404 to actuate the project by shortening the distance and expanding the cross-sectional area of the project.

[0213] FIG. 58 is an isometric view of an exemplary cannula 5500 for suturing cardiac tissue 900 according to one aspect of the present disclosure, an exemplary project 5402 made of a biocompatible or bioabsorbable material advanced from the cannula 550, and a control wire tensioned to shorten the project 5402. Note that the control wire 5404 may be drawn out via the advancement member 5702. And the control wire 5404 intervening between the openings in the project 5402 may pull in or shorten the project 5402. Therefore, the project 5402 may become a lump.

[0214] FIG. 59 is an isometric view of an exemplary project 5402 made of a biocompatible or bioabsorbable material in a state where tension is applied to shorten the project 5402 when an exemplary cannula for suturing cardiac tissue 900 according to one aspect of the present disclosure is withdrawn and held on the cardiac tissue surface. When the cannula is withdrawn and the project 5402 is shortened and compressed, the initial incision made by the cannula is closed or fixed.

[0215] Referring to FIG. 60, an isometric view of an exemplary plug 6002 made of a biocompatible or bioabsorbable material, according to one aspect of the present disclosure, is provided. The concentric plug 6002 made of a biocompatible or bioabsorbable material may be introduced in a manner similar to other plugs. The concentric plug 6002 may be made of the same or similar material as other plugs. The control line 6004 is connected to the concentric plug 6002 so that the concentric plug 6002 can be pulled back to contract or bunch up the concentric plug 6002 to increase the cross-sectional area and apply a greater compressive force to the tissue plane.

[0216] FIG. 61 is an isometric view of an exemplary cannula 5500 for suturing heart tissue 900 beside a plug 5402, according to one aspect of the present disclosure. The cannula 5500 may be placed in the tissue 900 in the vicinity of other plugs 5402. Generally, as described above, the plugs may be inserted into each other to maintain the integrity of the surrounding tissue and allow for re-access. This arrangement may provide an incision instrument disposed between the plugs to create an incision and a therapeutic or diagnostic instrument inserted into the incision.

[0217] FIG. 62 is an isometric view of an exemplary concentric plug 6002 made of a biocompatible or bioabsorbable material advanced through an exemplary cannula 5500 for suturing heart tissue 900, according to one aspect of the present disclosure. The advancement member 5702 may be used to push or advance the plug 6002 through the cannula 5500. The plug 6002 connected to the control line 6004 may be pushed into the tissue 900 through the cannula 5500 adjacent to other plugs 5402.

[0218] FIG. 63 is an isometric view of an exemplary cannula 5500 for suturing heart tissue 900 according to one aspect of the present disclosure, an exemplary preject 6002 made of a biocompatible or bioabsorbable material advanced out of the cannula 5500, and a control wire tensioned to shorten the preject. The control wire of the concentric preject 6002 may be drawn out via an advancement member 5702. By doing so, the concentric preject 6002 may be shortened or bundled.

[0219] Referring to FIG. 64, an isometric view is provided of an exemplary concentric preject 6002 made of a biocompatible or bioabsorbable material tensioned to shorten the preject 6002 according to one aspect of the present disclosure, and an exemplary incision 6402 made between prejects 5402 and 6002. The prejects 5402 and 6002 may provide anchor points where the tissue 900 can be tied together.

[0220] To provide the incision 6402 therebetween, an incision instrument as described above may be used. Although a straight cut is shown, other types of incisions 6402 may be formed. These include, but are not limited to, straight cuts, V-cuts, zigzag cuts, crescent arcs, etc. With both tissue fixation prejects 5402 and 6002 in place, the incision 6402 may then be formed.

[0221] FIG. 65 is an isometric view of an exemplary treatment instrument 4900 disposed in the incision 6402 between prejects 5402 and 6002 and reaching the tissue 900 according to one aspect of the present disclosure. When the treatment instrument 4900 is disposed therein, the spread of the incision 6402 may occur. The treatment instrument 4900 may follow a guide wire inserted for another mechanism introduced into the right atrium. Also, a diagnostic instrument may be used.

[0222] FIG. 66 is an isometric view of an exemplary knot 6602 advanced to heart tissue 900 using two pretension control lines 5404 and 6004, according to one aspect of the present disclosure. When using and removing the treatment device 4900, the securing knot 6602 may be advanced by tightening the control lines 5404 and 6004 of the pretension.

[0223] Referring to FIG. 67, an isometric view of an exemplary knot 6602 advanced to heart tissue 900 using two pretension control lines 5404 and 6004 and tightly pulled from the knot side of the tissue 900 is provided, according to one aspect of the present disclosure. When pulled, the control lines 5404 and 6004 can further advance the knot 6002 relative to the tissue 900. Note that the control lines 5404 and 6004 can also be cut and shortened, as will be described later.

[0224] FIG. 68 is an isometric view of an exemplary knot advanced to heart tissue 900 using two pretension control lines and tightened from the knot side of the tissue 900, according to one aspect of the present disclosure. When tightened, the pretensions 5402 and 6002 can collapse towards each other with the tissue 900 folded therebetween.

[0225] FIG. 69 is an isometric view of an exemplary incision 6402 closed between pretensions, according to one aspect of the present disclosure. The control lines used to create the knot 6602 may be removed or cut. This may remove interference within the patient in some cases.

[0226] In addition to sutures or mechanical devices for connecting the ends of tissues, adhesive materials may be used to seal or connect tissues as primary or auxiliary or accessory mechanisms. These materials include, but are not limited to, alkyl cyanoacrylates such as adhesive cyanoacrylate, methoxypropyl cyanoacrylate, n-butyl, isobutyl or n-octyl cyanoacrylate, octyl cyanoacrylate, butyl cyanoacrylate, BioGlue® Surgical Adhesive (BioGlue, bovine serum albumin (BSA), purified (BSA) glutaraldehyde, extracellular matrix ECM human connective tissue, autologous and homologous fibrin sealants, fibrin glue, polyethylene glycol (PEG)-based hydrogel sealants, hydrogels, methacryloyl-substituted tropoelastin (MeTro), and many others. These sealants may have biocompatibility and resorbability.

[0227] In one embodiment, a "bipolar" catheter type mechanism may be used to re-seal the tissue. For example, a bipolar coagulation forceps used for hemostasis of blood vessels may be used. There may be alternative options in the order for performing this procedure.

[0228] Figure 70 is a flowchart showing an exemplary process for enabling large-bore transseptal access with subsequent atrial re-access, according to one aspect of the present disclosure. These steps are for illustrative purposes and can be modified according to the techniques described herein. The process may start from block 7000.

[0229] In block 7002, a guide wire may be inserted into the ventricle and positioned in the atrial septum. The guide wire may be inserted into the venous circulation system from a vascular introducer sheath. The initial transseptal puncture or incision may be performed, for example, at the patient's femoral vein. Other sites where the guide wire may enter the patient may include, but are not limited to, the jugular vein, subclavian artery, subclavian vein, brachial artery and vein.

[0230] The guide wire may be routed cephalad through the inferior vena cava to the right atrium of the heart. The guide wire may be placed across the atrial septum to direct a therapeutic or diagnostic catheter into the region of the heart. In that case, the guide wire may be temporarily or removably secured to the atrial septum.

[0231] In block 7004, the atrial septum may be punctured with a needle into the left atrium. The septum penetrator may be a needle with a sharp distal tip or a structure elongated in the shaft direction. In one embodiment, the septum penetrator may be resident within the guide wire. The septum penetrator can be actuated at the proximal end of the vascular device via a control mechanism such as a button, lever, handle, or trigger, which may be permanently or removably attached via a linkage running the length of the device, a pusher rod, an electrical bus, etc.

[0232] The guide wire may be used as a puncture device. Without limitation, the guide wire may have a tip that facilitates crossing of the septum, such as a tip, helical tip, RF energy electrode tip, other energy tip, or other device that aids in tissue penetration.

[0233] The suture may be pulled through the puncture site in block 7006 via an anchor. The suture may be bundled within a suture bundle and housed within a recess of the anchor. The catheter shaft may be placed within the right atrium and the anchor with the suture bundle advanced into the left atrium from the puncture site. Then, the suture bundle may be fed out by a snare that captures a needle connected to the end of the suture. The snare with the needle may be retracted into the catheter shaft. The suture from the suture bundle may be managed via the snare.

[0234] The suture may be made from the right atrium to the left atrium or from the left atrium to the right atrium depending on the device. The suture may secure multiple engagement points by being placed multiple times across the septum. The suture may be another type of device such as a helical anchor or barb device. Also, the suture may be placed after the treatment of block 7012 is completed.

[0235] In block 7008, after the suture is placed in place, an incision may be formed in the atrial septum using a cutting instrument proximal to the needle passage. The suture may be deployed from a hole made near the first puncture site. The incision and cut may be made parallel so that the suture is not cut by the cutting instrument. The cutting instrument may be connected to the catheter so that the cutting instrument does not accidentally cut the suture.

[0236] In this specification, various cutting instruments have been described. Mechanical energy or RF energy may be used. When using electrical energy, the amount of exposed metal can be minimized by an insulator so that the exposed metal is only present in the desired tissue cutting area of the tool. Mechanical energy may use a blade deployed in one direction or a blade deployed symmetrically. The incision may be made from the right atrium to the left atrium or from the left atrium to the right atrium depending on the device. The incision may be made after the anchor is placed. Alternatively, the incision may be made earlier by the placement of the suture anchor described in block 7006. The incision may be integrated into blocks 7002 and 7004 with a device that punctures and incises tissue.

[0237] In block 7010, the suture can be managed. That is, the suture can be pulled towards the vessel wall and moved or manipulated so as not to interfere with or become entangled with the treatment instrument catheter. The tissue suture management line may be managed in the lumen of the access sheath or with another catheter.

[0238] Treatment may be performed using a treatment instrument in block 7012. The treatment device may perform diagnostic and therapeutic interventions, for example, for atrial fibrillation correction, mitral valve repair, septal defect correction, or implantation of an artificial heart. Treatment and diagnosis may be performed in the left atrium. Conversely, the treatment instrument may be removed.

[0239] In block 7014, the control suture may be used to close the incision. The amount of this closure may be adjusted according to the desired treatment goal. In some cases, it may be desirable to completely seal the incision, while in other cases, a passage may be left to relieve excessive pressure from one side to the other. In one example, the control suture may be pressed against the tissue described above. The process may end in block 7016.

[0240] Also, other techniques may be used to enable atrial re-access with a large-bore transseptal access. For example, and in this embodiment, the method may include puncturing the septum for needle passage, leaving a suture or some other anchor behind, and then performing the procedure. The remaining anchors and sutures may be tightened together to close the septum. Then, the excess suture may be cut.

[0241] In another approach to atrial re-access, the septum may first be incised. The septum can stabilize the puncture radius of the needle so that the needle can pass through the previously incised septum. A needle passage device may be introduced. The needle on the left atrium side can be snared / gripped and pulled through the catheter. It is also possible to penetrate the septum with a nitinol wire. A control structure may be used to cut the excess suture to close the incision.

[0242] In yet another approach, transseptal access may be obtained by a standard transseptal approach. The guidewire may be left across the transseptal access site in the left atrium. Over the guidewire, a vascular device for incising, dilating, and suturing is advanced. Four radially arranged incising members may slice through the septum and expand the transseptal access point in a controlled and consistent manner. Thereafter, the septum is punctured with a needle, and a suture is passed through the interatrial tissue at a position between the slices where iatrogenic ASD can be optimally closed when the slices are tightened. Thereafter, the vascular device may be removed while leaving four sutures across the septum. The sutures may be withdrawn from the vein and may remain temporarily in the inferior vena cava until a later procedure.

[0243] In yet another technique, the suture, anchor, incising instrument, and mechanism for facilitating delivery of the closing function may be integrated into the treatment device to minimize device exchange within the patient's body.

[0244] In yet another approach, foreign objects may be left out. This technique may involve, along with the associated device, clamping for a period of time to promote healing while sealing the tissue that enters and adheres to the atrium after the procedure. Consequently, it may be a technique involving removal of structures or devices. This technique may be a combination of controlled incision and subsequent clamping by the devices described herein or known in the art. Without limitation, the devices include grabbers, forceps, helical anchors, pinchers, knots, suction devices, barbs, etc. And this technique may also promote natural healing of the tissue by the incision pattern. The duration of this temporary crimping may range from several minutes to several days or weeks, depending on the degree of desired tissue healing.

[0245] In some embodiments, the above-described anchor may subsequently be removed from the tissue or, alternatively, may be left in place. Techniques and procedures for removing the anchor can include using a grasper, snare, cutting element, or engagement function specific to the mechanism. A mechanical function may be added to the right atrial side of the anchor device to allow subsequent grasping and unscrewing. This mechanical function may be in the form of a hook or an oval shape. This function may protrude from the right atrial septum, for example, so that it can be grasped with a snare and rotated from the tissue.

[0246] 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 readily apparent to those skilled in the art, and the general principles defined herein may be applied to other embodiments. Thus, the claims are not intended to be limited to the embodiments shown and described herein, but are to be accorded the full scope consistent with the language of the claims, and the reference to singular elements is not intended to mean "only one" unless specifically stated otherwise, but rather "one or more." All structural and functional equivalents known or later known to those of ordinary skill in the art to the various elements of the various embodiments described throughout this disclosure are expressly incorporated herein by reference and are intended to be encompassed by the claims. Further, the disclosure herein is not intended to be dedicated to the public regardless of whether such disclosure is expressly recited in the claims.

Claims

1. 1. A vascular device for performing a transseptal puncture, comprising: A catheter shaft; an anchor disposed at and extendable from a distal end of the catheter shaft; at least one thread extending rearwardly from the anchor toward the catheter shaft; at least one suture attached to one of the needles; at least one lumen within the catheter shaft axially aligned with each of the at least one needle; a dissection tool positioned between the catheter shaft and the anchor, the dissection tool having an expanded state with a larger diameter than the catheter shaft.

2. A vascular device for performing transseptal puncture as described in claim 1, wherein the cutting instrument is connected to an expansion actuation shaft and the anchor is connected to an advancement shaft.

3. A vascular device for performing transseptal puncture as described in claim 2, wherein the expansion actuation shaft slides freely and retractably relative to the advancement shaft.

4. A vascular device for performing transseptal puncture as described in claim 1, wherein the cutting instrument in its expanded state is parallel to the at least one suture to eliminate the possibility of cutting the at least one suture.

5. A vascular device for performing transseptal puncture as described in claim 1, wherein the cutting instrument is a linkage system including a blade.

6. A vascular device for performing transseptal puncture as described in claim 1, wherein the at least one suture is contained in a recess channel of the anchor.

7. A vascular device for performing transseptal puncture as described in claim 6, wherein the recess channel is configured to release the at least one suture after being pulled by a snare.

8. A vascular device for performing transseptal puncture as described in claim 6, wherein the recess channel accommodates two of the sutures.

9. A vascular device for performing transseptal puncture as described in claim 6, wherein the recess channel is shaped to release the suture.

10. A vascular device for performing transseptal puncture as described in claim 6, wherein the recess channel accommodates two of the sutures.

11. A vascular device for performing transseptal puncture as described in claim 1, further comprising a snare positioned within the lumen.

12. A vascular device for performing transseptal puncture as described in claim 11, wherein the inner cavity includes a recess into which a snare engages.

13. A vascular device for performing transseptal puncture as described in claim 11, further comprising a mechanism accessible from the proximal end of the catheter shaft for moving the snare to capture and withdraw the needle.

14. A vascular device for performing transseptal puncture as described in claim 1, wherein the at least one needle includes four needles and the at least one suture includes two sutures.

15. A vascular device for performing transseptal puncture as described in claim 1, wherein the cutting instrument is configured to use mechanical energy or electrical energy.

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