Manual internal guidewire steering for annuloplasty

Abstract

This invention provides a minimally invasive endovascular annulusoplasty system and method of use. The system includes a guide catheter configured to guide a working catheter to a treatment site within the heart chamber. The guide catheter may be translatably disposed within a working catheter, which may be translatably disposed within a guide sheath extending into the heart chamber. The guide catheter may be sized to reduce noise and / or may be constructed of materials that facilitate visualization. In one embodiment, the guide catheter includes a distal guidewire anchor. Visualization can be used to embed the distal guidewire anchor into the tissue at the target site.

Description

Technical Field

[0001] This disclosure generally relates to the field of medical devices, and more specifically to a valve annuloplasty system and method of use. Background Technology

[0002] The tricuspid valve is located between the right atrium and right ventricle of the heart, and its function is to prevent backflow of blood that has entered the right atrium from the right ventricle. The tricuspid valve consists of three leaflets: the anterior leaflet, the posterior leaflet, and the septal leaflet. Each leaflet is connected to the anterior, posterior, and septal papillary muscles of the right ventricle via chordae tendineae.

[0003] In a healthy heart, the tricuspid valve acts as a one-way valve, closing during ventricular systole to prevent tricuspid regurgitation (TR) from entering the right atrium. In a diseased heart, tricuspid valve dilation during systole can cause the valve to fail to close effectively. Consequently, blood regurgitation occurs during ventricular systole, resulting in reduced cardiac output.

[0004] The goal of tricuspid valve repair is to restore valve capacity by restoring the physiological morphology and function of the valvular organ. An exemplary technique may utilize clamps or other devices to reduce the valve between the midpoint of the anterior leaflet and the junction (CS) of the septum. Valve repair / replacement can be performed via open-heart surgery or using endocardial methods. In either case, atrial fibrillation (AF) is a common side effect, at least in part, caused by unintended contact with cardiac features and associated damage to the cardiac nervous system. Unintended contact can result from delivering the valve repair assembly via an annuloplasty catheter and positioning it near the diseased valve. To minimize unintended contact, the positioning of the annuloplasty catheter can be visualized using methods such as echocardiography. In some systems, the size of the annuloplasty catheter interferes with visualization, affecting accuracy and increasing the risk of unintended contact with cardiac features and associated damage. Positioning the annuloplasty catheter can be particularly challenging for patients with pacemakers and defibrillator leads. Tricuspid valve displacement, the use of antiplatelet and anticoagulant drugs, and a high recurrence rate of tricuspid regurgitation can be caused by or exacerbated by neurological damage. The goal is to discover valve repair systems that reduce or overcome these problems. Summary of the Invention

[0005] Embodiments of this disclosure relate to a minimally invasive endovascular annulusoplasty system and method of use. The system includes a guide catheter configured to guide a working catheter to a treatment site within the heart. The guide catheter may be translatably disposed within the working catheter, which may be translatably disposed within a guide sheath configured to extend transluminally into the heart. The guide catheter may be sized for low noise and / or may be constructed of materials that facilitate visualization. In one embodiment, the guide catheter includes a distal guidewire anchor configured to be embedded in the tissue at the treatment site. The working catheter can then travel directly over the guide catheter to the treatment site, thereby reducing the likelihood of accidental contact between the working catheter and other cardiac features.

[0006] According to one aspect, the system includes: a guide sheath having a lumen extending from a proximal end to a distal end and configured to travel cavitarily into a cardiac chamber including a treatment site; a working catheter configured to be longitudinally translated within the guide sheath to position a distal end of the working catheter near the distal end of the guide sheath; and a guide catheter translatably disposed within the working catheter, the guide catheter including a translation mechanism configured to allow the distal end of the guide catheter to travel past the distal end of the working catheter to the treatment site, thereby providing a path for the working catheter to reach the treatment site.

[0007] In some embodiments, the guiding catheter may include a distal guidewire anchor located at its distal end, and a translation mechanism configured to drive the distal guidewire anchor into the tissue at the treatment site to secure the guiding catheter to the treatment site. In various embodiments, the distal guidewire anchor may include at least one of a helical member, a clamping member, a hook member, or a needle member. The proximal end of the guiding sheath may include a steering controller coupled to the distal end of the guiding sheath to guide the distal end of the guiding sheath to the cardiac chamber. The working catheter may include a distal tissue engagement mechanism and a proximal tissue engagement control mechanism.

[0008] In some embodiments, the system may include an implantable stylet slidably disposed within the working channel of a working catheter, the implantable stylet including at least one implantable component supported within the distal end of the implantable stylet. The system may include a stage structure comprising at least one of a guide sheath support, a working catheter support, or an implantable stylet support. The stage structure may include a catheter hub (including a track), and the working catheter support may be slidably disposed on the track of the catheter hub such that movement of the working catheter support along the track causes translation of the working catheter within the guide sheath.

[0009] In some embodiments, the translation mechanism may be further configured to retract the guide catheter into the distal end of the working catheter. Some embodiments may include a visualization mechanism positioned near the distal guidewire anchor on one of the guide catheter, the distal guidewire anchor, or the working catheter. The visualization mechanism may include, for example, an intracardiac ultrasound (ICE) sensor.

[0010] According to another aspect, the annulus repair method includes the following steps: advancing a guide sheath having a lumen extending from the proximal end to the distal end through the cavity into a heart chamber including the treatment site; advancing the distal end of a working catheter to the distal end of the guide sheath; advancing a guide catheter through the distal end of the working catheter to the treatment site to provide a path for the working catheter; and securing the distal end of the guide catheter to the treatment site.

[0011] In some embodiments, the method may include translating a working catheter along a path provided by a guide catheter to a treatment site. The method may also include retracting the working catheter from the treatment site over the guide catheter to position the distal end of the working catheter near the distal end of the guide sheath. The method may include releasing the distal end of the guide catheter from the treatment site, allowing the distal end of the guide catheter to travel to a second treatment site, and allowing the distal end of the working catheter to travel over the guide catheter to the second treatment site.

[0012] According to another aspect, the catheter system includes: a working catheter configured to travel at least within a guiding catheter to a position within a heart chamber, wherein a distal end of the working catheter is removed from a treatment site within the heart chamber; a guiding catheter translatably disposed within the working catheter, the guiding catheter including a translation mechanism configured to allow the guiding catheter to travel through the working catheter to the treatment site, the guiding catheter including an attachment mechanism for engaging the distal end of the guiding catheter to the treatment site and a mechanism configured to slidably allow the working catheter to travel along the guiding catheter to the treatment site. In some embodiments, the catheter system may further include a distal guidewire anchor coupled to the guiding catheter, and the translation mechanism is configured to drive the distal guidewire anchor into tissue at the treatment site to secure the guiding catheter to the treatment site. In various embodiments, the distal guidewire anchor may include at least one of a helical member, a clamping member, a hook member, or a needle member. The working catheter may include a valve annuloplasty catheter including a tissue engagement mechanism at its distal end, the tissue engagement mechanism including at least one of a needle, a hook, a clamp, a screw, or a frame or anchor. In some embodiments, the catheter system may include a visualization mechanism located near the attachment mechanism of the guiding catheter. Attached Figure Description

[0013] Non-limiting embodiments of the present disclosure are described below by way of example and with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. In the drawings, identical or substantially identical components are generally indicated by a single number. For clarity, not every component is labeled in each drawing, nor in each embodiment, where such description is unnecessary to allow those skilled in the art to understand the disclosure. In the drawings:

[0014] Figure 1 A valve annuloplasty system according to an embodiment of the present disclosure is shown;

[0015] Figure 2A and Figure 2B A perspective view of a guide sheath according to an embodiment of the present disclosure is shown;

[0016] Figure 3 yes Figure 1 Alternative view of the annulusoplasty system;

[0017] Figure 4A , Figure 4B and Figure 4C A perspective view of a working conduit according to an embodiment of the present disclosure is shown;

[0018] Figure 5A and Figure 5B A perspective view of one embodiment of the distal end of a working conduit according to the present disclosure is shown;

[0019] Figure 6 An embodiment of the proximal handle of the working catheter according to this disclosure is shown;

[0020] Figure 7 An embodiment of a guide sheath according to this disclosure is shown;

[0021] Figure 8 An embodiment of a working conduit according to this disclosure is shown;

[0022] Figure 9A and Figure 9B An embodiment of a guiding catheter, as disclosed herein, is shown at the treatment site;

[0023] Figure 10 An embodiment of a working catheter, as disclosed herein, is shown that travels along a guide catheter to the treatment site;

[0024] Figure 11 An embodiment of a valve annulusop system including an implanted stylet is shown according to the present disclosure;

[0025] Figure 12A and Figure 12BVarious views of one embodiment of the retraction distal end of the guiding catheter as disclosed herein are shown;

[0026] Figures 13A-13C Various embodiments of a visualization mechanism for a catheter system according to this disclosure are shown;

[0027] Figure 14A and Figure 14B An embodiment of a valve annulusop system including a tissue bonding frame according to the present disclosure is shown; and

[0028] Figure 15A and Figure 15B An embodiment of a valve annuloplasty system including an online tissue connection mechanism according to the present disclosure is shown. Detailed Implementation

[0029] According to one aspect, a minimally invasive endocardial annulus repair system and method of use are provided. The system includes a guide catheter configured to guide a working catheter to a treatment site within the heart chamber. Due to this arrangement, the possibility of accidental contact and associated cardiac injury can be reduced through controlled travel and accurate placement of the working catheter during annulus repair.

[0030] In one embodiment, the guide catheter may be translatably disposed within the working catheter, which in turn may be translatably disposed within the guide sheath extending into the heart chamber. The guide catheter may be configured to facilitate visualization of its distal end. For example, the guide catheter may be sized to reduce noise and / or may be constructed of materials that facilitate visualization. In one embodiment, the guide catheter includes a distal guidewire anchor. Visualization can be used to embed the distal guidewire anchor into the tissue at the target site. The working catheter can then be allowed to travel directly over the guide catheter to the treatment site, reducing the likelihood of accidental contact with cardiac features. In some embodiments, visualization may be further improved by providing a channel for an intravascular echocardiography (ICE) catheter within the working catheter. In some embodiments, the ICE catheter may be formed distal to the guide catheter.

[0031] In some embodiments, the annulusoplasty system may further include an implant placement system. This implant placement system may include tissue engagement mechanisms and / or tissue remodeling mechanisms. The implant placement system may be part of the working catheter or may include other components that can be delivered through the working catheter using an implantable stylet or other forms of catheter.

[0032] According to one aspect, the annulusoplasty system may include multiple nested catheters that increase in length as their diameter decreases. This arrangement allows one or more working catheters and / or implant placement systems (including, for example, frames, anchors, screws, cages, valves, clamps, etc.) to be interchangeably and precisely placed on top of (along the guide catheter) the treatment site with minimal disruption.

[0033] These and other advantages of the annulusoplasty system are described below. It should be noted that although embodiments of this disclosure may be described with specific reference to the tricuspid valve, the principles disclosed herein can be readily adapted to facilitate the reconstruction of any valve annulus, including, for example, the mitral valve annulus, and / or may similarly benefit any other dilatation, valvular insufficiency, valvular leak, and other similar heart failure conditions.

[0034] As used in this article, the term "distal" refers to the end furthest from the medical professional when the medical device is inserted into the patient, while the term "proximal" refers to the end closest to the medical professional when the medical device is inserted into the patient.

[0035] Figure 1 A benchtop testing apparatus is shown, comprising a representative heart 200 for use with an annulusoplasty system 100. The annulusoplasty system 100 is shown to include a nested catheter assembly 120 comprising multiple catheters that can individually or jointly travel transluminally into the heart 200 to repair and / or replace valves or other cardiac structures. A benchtop 150 may be configured with a catheter hub 155 that stabilizes the annulusoplasty system 100 during annulusoplasty. Although... Figure 1 A worktable apparatus is shown that can support a catheter assembly 120 with a catheter seat 155 during annuloplasty, as described below. In some embodiments, the catheters of the catheter assembly 120 may include proximal handles that include one or more control mechanisms configured to control the movement and / or function of the catheters. The catheter seat 155 may include a plurality of handle supports 130, 132, 134, each configured to support a handle of one of the catheters in the catheter assembly 120. In some embodiments, one or more of the handle supports 130, 132, 134 may be slidably disposed on a track 165 of the catheter seat 155 and may be, for example, locked in place by a lockable support 133 or 135 when the distal end of the catheter supported by the respective handle is positioned for annuloplasty.

[0036] exist Figure 1In one embodiment, the figure shows that the catheter assembly 120 includes a guide sheath 122, a working catheter 124, and an implanted stylet 126. It should be understood that although the number and arrangement of the guide, working sheath, and implanted sheath / catheter and / or stylet are described by way of some embodiments, the principles disclosed herein can be extended to other types, numbers, and arrangements of catheters.

[0037] exist Figure 2A Side perspective and Figure 2B The guide sheath 122 is shown in a top view. The guide sheath 122 includes a shaft 210 having a distal end 205 and a proximal end 215 coupled to a handle 225. The shaft 210 may be a steerable shaft including embedded pull cables that can be coupled to a mechanism in the handle 225 configured to deflect the distal end of the shaft 210 as it travels through the lumen of an artery or vein into the heart chambers. The handle 225 may include a steering control mechanism (such as a dial 220) that controls the deflection of the distal end 205 of the guide sheath 122. Alternative steering control mechanisms may include, for example, a thumbwheel, a dial 220, a knob, a switch, etc.

[0038] According to one aspect, the guide sheath 122 includes a guide lumen that extends axially through the catheter 122, such as by... Figure 2A The straight line “A” is shown. The dimensions of the guide’s lumen are designed to support the working catheter, such as annulusop catheters that include implanted components.

[0039] In one embodiment, the guide sheath 122 may comprise a composite layer of thermoplastic elastomer (TPE), such as PEBAX supplied by ARKEMA of Colombes France. Alternatively, nylon, polyurethane, polyester, polysiloxane, or other similar materials may be used to provide thin walls that may be extruded and layered over the braided yarn or coil to increase tensile and circumferential strength, although the disclosed system is not limited to any particular material composition for the guide sheath. In some embodiments, the length of the shaft 210 may be in the range of 24”–52”, more specifically between 42”–46”. In one embodiment, the inner diameter may be between 24 and 31 Fr, and the outer diameter may be in the range of 26 Fr and above 34 Fr. In one exemplary embodiment, the inner diameter may be, for example, 28 Fr and the outer diameter may be 32 Fr.

[0040] In one embodiment, connector 230 may be positioned proximal to handle 225. Connector 230 may be configured to mate with, for example, a working catheter. In some embodiments, connector 230 may advantageously include a hemostatic valve to minimize blood loss during annulusoplasty.

[0041] In some embodiments, the handle 225 may include configurations for engaging, locking, or coupling the handle 225 to the catheter hub 155. Figure 1 The structure is designed to minimize movement of the guide sheath after placement. For example, the guide sheath 122 includes a neck 213 configured to engage with the quick-release pin of the handle support 130. Figure 1 ) join.

[0042] Figure 3 An embodiment of an annulusoplasty system arranged for testing on a test bench is shown, wherein the distal end of the guide sheath 122 has been extended into the cavity of the heart 200. The figure shows that during annulusoplasty, the neck 213 has been locked into the quick-release pin of the handle support 130. Once the guide is in place, annulusoplasty can be initiated using, for example, the working catheter 124 and / or the stylet 126.

[0043] For the purposes of this application, the "working" catheter can be any catheter that carries or controls one or more components that can be used or configured to repair and / or replace a heart valve. Similar to a guide sheath, the working catheter may be made of nylon elastomer (PEBAX), nylon, polyurethane, polyester, polysiloxane, or other similar materials. The working catheter may include one or more tissue engagement mechanisms at its distal end, such as needles, hooks, anchors, clamps, screws, struts, etc., wherein the tissue engagement mechanism may be configured to engage with cardiac tissue as part of annulusoplasty. According to one aspect, the working catheter may also include (or be adapted to receive) a guide catheter, wherein the guide catheter guides the working catheter to the treatment site within the heart chamber in a precise and controlled manner, as described below. Typically, the working catheter is in the range of 6Fr-27Fr. For example, it is assumed that a guide sheath with a 34Fr OD and 30Fr ID, or a 27Fr or 28Fr working catheter, can translate within the guide without limitation on the sharp bend radius.

[0044] Figures 4A-4C An exemplary working conduit 124 is shown in multiple perspective views. Figure 4A The top-down perspective view of the working conduit 124 shows that the conduit 124 includes a distal end 405, a proximal end 415, and a working shaft 410 disposed between these two ends. A channel B extends between the proximal end 415 and the distal end 405 of the working conduit 124. The proximal end 415 is shown to include a handle 425, which includes a tissue engagement control 420 and a guide conduit control 430. The tissue engagement control 420 is shown to include a tissue engagement lock 422. In one embodiment, the tissue engagement lock 422 includes a dial that allows rotation of the distal end 405 of the shaft 410 in a first position and locks the distal end 405 of the shaft 410 in a fixed position in a second position. Figure 4AThe diagram shows that the guide catheter control unit 430 includes a proximal end of a guide catheter 427 disposed within the channel B of the shaft 410, and a guide catheter lock 432. In one embodiment, in a first position, the guide catheter lock 432 allows axial translation and directional movement of the guide catheter 427 within the channel B, and in a second position, the guide catheter lock 432 locks the distal end of the guide catheter 427 in a fixed position.

[0045] In an exemplary embodiment, the guiding catheter 427 may be made of materials such as block polyetheramide (PEBAX), nylon, polyurethane, polyester, polysiloxane, or other similar materials. In one embodiment, the guiding catheter 427 is a steerable catheter size, for example, with a diameter of less than 9 Fr, so that it is slidably disposed at least inside the distal end of the working catheter and configured to extend through the distal end of the axis 410 of the working catheter 124. Due to its relatively small size, the guiding catheter can be more easily visualized in the heart chambers, thereby improving the accuracy of placement of annulusoplasty components during the procedure.

[0046] Figure 4B A bottom perspective view of the working catheter 124 is shown, with the handle 425 at the proximal end 415 on the underside, including a guide catheter control 430 and a tissue engagement control 420. Figure 4B In the image, the distal guide wire anchor 411 extends through the distal end 405 of the shaft 410 of the working conduit 124.

[0047] The figure shows a guide catheter control unit 430 on handle 425, including a steering controller 470 on a first surface and a translation mechanism 450 disposed on different surfaces. Although not essential, providing control on different surfaces of the handle allows the surgeon to more easily steer and advance the distal end of the guide catheter with one hand. In one embodiment, the steering controller 470 includes a rotatable lever, although other similar mechanisms (such as wheels, dials, etc.) may be used instead. The translation mechanism 450 may include a thumbwheel or other similar mechanism, wherein rotation of the thumbwheel in a first direction allows the guide catheter to advance past the distal end of the working catheter 124 and rotation of the thumbwheel in the opposite second direction retracts the guide catheter back into the working catheter 124.

[0048] Figure 4C A side perspective view of a working catheter 124 is shown, which includes a handle 425 with a tissue engagement control 420 and a guide catheter control 430 at a proximal end 415, a shaft 410, and a distal guidewire anchor 411 at a distal end 405. Figure 4C As can be seen in more detail, the steering controller 470 includes a lever that can be controlled with the thumb, etc., to steer the guide tube while simultaneously using the translation mechanism 450 to move it forward or retract it. Figure 4BOnce the distal guidewire anchor 411 is secured, the guide catheter lock 432 can be activated to fix the position of the distal guidewire anchor 411. The tissue engagement control unit 420 may also include controls, such as a lever 460 that can be used to steer the distal end 405 of the shaft 410. Once the steered distal end 405 of the shaft 410 is in the working position, the tissue engagement lock 422 can be activated to maintain the working position of the shaft 410.

[0049] Figure 5A and Figure 5B The distal end of the working catheter 500 is shown in more detail, in which Figure 5A This is a side perspective view of the working conduit 500, and Figure 5B This is a proximal view of the distal end of catheter 500. In both views, the guide catheter 510 is shown extending through channel 505 at the distal end of the working catheter 500. The working catheter 500 also includes a tissue engagement mechanism, such as a needle 530, which can be controlled by a tissue engagement mechanism feature of the handle of the working catheter, as described above. Figures 4A-4C As described above, although a needle is shown, Figure 5A and Figure 5B One type of working catheter has been shown, and other types of catheters that include tissue engagement devices (such as clamps, anchors, needles, struts, teeth, or other types of devices that can be used at least temporarily to engage the distal end of the working catheter with cardiac tissue for annulusoplasty) are considered equivalent.

[0050] In one embodiment, the distal end of the guiding catheter 510 may include a distal guidewire anchor 520. The distal guidewire anchor 520 may be made of stainless steel, nickel-titanium alloy, etc., and may include a sharp distal end configured to secure the guiding catheter 510 to the treatment site. The distal guidewire anchor may have a total axial length of about 2 mm to about 10 to about 15 cm (mm) and a diameter of about 0.2 mm or less. The distal guidewire anchor 520 may include an attachment mechanism, which may take many forms, including but not limited to spirals, clamps, hooks, needles, etc. In one embodiment, one of the distal guidewire anchor 520 and / or the distal portion of the guiding catheter 510 may be made of materials such as nickel-titanium alloy, stainless steel, polyetheretherketone (PEEK), polymers, or other materials that provide high visibility under echocardiographic imaging and / or fluoroscopy. In some embodiments, the distal guidewire anchor 520 may have features that facilitate visualization, including but not limited to a platinum-iridium marking strip (not shown) made of a thin-walled seamless platinum-iridium alloy. Marking tapes may also be included for radiopaque marking of catheters and sensors during fluoroscopic angioplasty and other procedures. Typical sizes of marking tapes include a diameter of about 0.2–8.0 mm, a wall thickness of about 0.015–0.5 mm, and a length ranging from about 0.2 mm to up to about 25 mm.

[0051] In one embodiment, the shaft 515 of the working catheter supports the tissue engagement mechanism 530 and includes a working channel 505. In some embodiments, the working channel 505 supporting the guide catheter 510 may extend along at least a portion of the length of the working catheter 500. According to one aspect, the position of the working channel within the working catheter is selected so as not to interfere with the tissue engagement mechanism 530 of the working catheter. A sheath 525 may be disposed above the shaft 515 and may be made of a material such as PEBAX to facilitate smooth translation of the working catheter within the guide sheath.

[0052] Figure 6 A handle 600 of a working catheter is shown fixed to a catheter holder 650, wherein a support 633 is configured to support the tissue junction 620 of the handle 600, and a support 635 is configured to support the guide catheter portion 630 of the handle 600. This arrangement secures the working catheter to prevent accidental movement of the handle 600 during use, which could dislodge the distal end of the working catheter. In the illustrated embodiment, the catheter holder 650 is shown to include a track 660 on which a skid 669 is slidably disposed. In one embodiment, the skid 669 may include support members 665, 668, which include ridges or other structures configured to slide in the track 660 to allow the skid 669 to translate along the track. The position of the skid 668 on the track 660 may be secured by a locking mechanism 667. Figure 6 In one embodiment, a second track 670 is shown positioned on a skid 669. The support member 672 includes structures for slidably engaging the support member 672 to the track 670, and includes a support 635 configured to support the guide catheter portion 630 of the handle 600. This arrangement facilitates controlled manual guidance of the distal end of the guide catheter to the annulusoplasty treatment site in a manner that minimizes the possibility of accidental contact with cardiac structures.

[0053] Now for reference Figures 7-1 3. An embodiment of the method of using the annulusop catheter system disclosed herein is described. Figure 7This is a top view illustrating a guide sheath 710 positioned above a diseased valve 720 in a waiting position (standby position, temporary position, temporary placement position). In one embodiment, a "waiting position" includes a location where the distal end of the guide sheath travels into the heart chamber but is spaced from or removed from the treatment site. The distance between the distal end of the guide sheath 710 and the treatment site 720 may vary depending on considerations including, but not limited to, patient anatomy, treatment site location, guide sheath construction, guide catheter length, and available visualization techniques, but should be sufficient to allow visualization of the treatment site without interference from the guide sheath or any catheter within the guide sheath. For example, in one embodiment, a waiting position for the guide sheath in annuloplasty may be a position where the guide sheath is relatively centered above the valve or annulus but spaced from it, for example, between 1-2 mm and 35-55 mm away from the valve or annulus.

[0054] exist Figure 8 In this process, the working catheter 730 is advanced through the guide sheath 710 until the tissue engagement mechanism 735 at the distal end of the working catheter 730 is positioned near the waiting position of the guide sheath 710. According to one embodiment, the waiting position of the working catheter is associated with the waiting position of the guide sheath and may include a position in which the tissue engagement mechanism 735 at the distal end of the working catheter 730 is exposed by the guide sheath 710 but sufficiently removed from the valve 720 to allow visualization of the valve without interference from the working catheter 730.

[0055] Figure 9A The passage of the guiding catheter 910 from the working catheter 730 toward the heart wall 940 is shown, while the tissue engagement mechanism 735 of the working catheter 730 is held away from the valve in the working catheter waiting position. Figure 9A As shown, a distal guidewire anchor 915 positioned at the distal end of the guiding catheter 910 can travel into the tissue until it is at least partially embedded. Figure 9B In this configuration, the distal guidewire anchor 915 (not shown) is completely embedded within the tissue of the heart wall 940 near the valve 720, and the guiding catheter 910 provides a guiding path to the heart wall 940. The working catheter 730 can then be advanced in a controlled manner over the guiding catheter 910 to move the tissue engagement mechanism 735 of the working catheter 730 to the heart wall 940.

[0056] exist Figure 10In this procedure, the working catheter 730 has been advanced along the path defined by the guiding catheter 910, and the tissue engagement mechanism 735 has been positioned adjacent to the heart wall to initiate annulusoplasty. Guiding the guiding catheter 910 (which has a profile of less than 9 Fr) to the treatment site greatly reduces the possibility of accidental contact, and if contact does occur, greatly reduces the impact of such contact. Once the guiding catheter 910 has been positioned and thus precisely targeted to the treatment site, the larger working catheter 730 can be placed on the guiding catheter in a controlled manner, thereby reducing adverse effects associated with annulusoplasty system placement. The working catheter 730 can be controlled to engage cardiac tissue by manipulating the tissue engagement mechanism controls on the handle of the working catheter. For example, in one embodiment, the tissue engagement mechanism 735 can be controlled to open and close to capture tissue from the heart wall, for example using lever 460 (…). Figure 4C )The needle and lock 422 of the tissue engagement mechanism 735 Figure 4A The needle is opened and closed to hold it in place at the tissue junction for delivery of the annulusoplasty repair component.

[0057] According to one aspect, such as Figure 11 As shown, one or more annulusoplasty components can be delivered into the heart chamber using an implantable stylet 126. In one embodiment, the implantable stylet 126 may extend distally through the lumen of the working catheter to precisely position the implantable component at the target treatment site. The structure of the implantable stylet will vary depending on the annulusoplasty procedure. For example, the implantable stylet may be configured to place one or more implantable components, including but not limited to: frames, cages, straps, anchors, clamps, sutures, or other mechanisms that can be used to reduce valve size. The placement of the implantable component can be controlled in a variety of ways. For example, in Figure 11 The image shows an implantable stylet including multiple collars 1101, 1102, each collar associated with an anchor. One or more implantable components can be positioned at the distal end of the stylet. The collars 1101, 1102 can be driven out or positioned at the distal end of the working catheter, for example, by advancing a pusher mechanism or other such device to push the component from the distal end. In some embodiments, a button or dial can be used to position multiple components.

[0058] After placement and proper manipulation of the annulusoplasty components, the working catheter 730 is moved to the next treatment site within the heart chamber with minimal impact on the cardiac structure. Therefore, in Figure 12A In this configuration, the working catheter 730 has been retracted to the working catheter waiting position (as described above), wherein the distal end of the working catheter is close to but exposed from the distal end of the guide sheath 710 in its waiting position. The clamp 1200 has been engaged with the target tissue site, and the guide catheter 910 can be released. In one embodiment, a translation mechanism 450 may be used. Figure 4B Release can be achieved, for example, by rotating the thumbwheel to retract the distal guidewire anchor from the tissue. Figure 4B As shown, the guide catheter 910 can then be retracted into the working catheter 730 before proceeding to the next treatment site. In other embodiments, after the release of the clamp 1200, the guide catheter 910 can be moved directly to the next treatment site without being retracted into the working catheter 730. Therefore, the disclosed annulusoplasty system allows surgeons to flexibly change the sequence of procedures based on the characteristics of the patient / disease valve and personal preferences.

[0059] In some embodiments, the distal guidewire anchor may include a portion of the implant, and retraction of the guide catheter may include the release of the distal guidewire anchor. In this embodiment, the guide catheter may include a plurality of distal guidewire anchors arranged in series within the lumen of the guide catheter and extruded at each target treatment site (e.g., by the action of a button or by other means).

[0060] Therefore, systems and methods for valve repair and / or replacement with improved visualization and accuracy have been illustrated and described. According to one aspect, it is generally believed that the benefit in accuracy can be further increased by incorporating a visualization device distal to the guiding catheter. Figure 13A The distal end of an exemplary guiding catheter 1300 is shown, including a distal guidewire anchor 1320 coupled to an intravascular echocardiography (ICE) catheter 1340, which includes an ICE sensor array 1342. As described above, the distal end of the working catheter may also include a tissue engagement mechanism (such as a needle 1330). In one embodiment, the ICE catheter 1340 can be rotated within the lumen of the working catheter supporting the guiding catheter to visualize various treatment sites within the cardiac chambers. In some embodiments, the guiding catheter including ICE imaging has a profile of less than 12 Fr, thereby enhancing visualization without negatively impacting the ability of the guiding catheter 1340 to minimally affect cardiac features.

[0061] In various other embodiments, the ICE sensor array 1342 may be positioned at other locations near the distal end of the catheter system. For example, the sensor array 1342 may be positioned on the surface of the tissue engagement mechanism 735 of the working catheter 730, such as... Figure 13B As shown, a visible area 1350 is provided to allow the user to visualize the tissue engagement mechanism 735 and the distal end of the guide catheter 910. Alternatively, a sensor array 1342 may be positioned at the distal end of the working catheter 730 (e.g., Figure 13C (as shown in the diagram) to provide a visualization range 1352, thereby enabling visualization of the distal end of the working catheter 910 and the tissue joining mechanism 35.

[0062] Alternative embodiments may involve placing an ultrasound catheter, such as the Acuson IPX8 AcuNav catheter located within the central lumen of the working catheter, as disclosed in U.S. Patent Application 15 / 352,288, filed November 15, 2016, entitled “IMPLANTABLE DEVICE AND DELIVERYSYSTEM FOR RESHAPING A HEART VALVE ANNULUS,” the entire contents of which are incorporated herein by reference. Using either method, by rotating the ultrasound device within the valve annulus, the relative position of the implanted components to the leaflets can be more easily visualized, thereby improving accuracy during annulusoplasty.

[0063] As described above, the concepts disclosed herein, including the use of a guiding catheter to more precisely target the treatment site, are suitable for a variety of annulusoplasty systems. Figure 14A and Figure 14B The adaptability of the described technique to frame-based annulusoplasty is demonstrated. For example... Figure 14A As shown, the guide sheath 1410 is inserted above the valve 1450, and using the scaffold-like frame 1420 as a tissue engagement member, multiple guidewires (such as guidewire 1405) can be advanced to a position close to the valve 1450. The guidewire anchor can be driven into the tissue close to the valve 1450, and as... Figure 14B As shown, the frame can then be removed. Guidewire 1405 may be retained during annuloplasty to guide the annuloplasty components to the treatment site near the valve. Once the treatment is complete, guidewire 1405 can be removed.

[0064] Figure 15A and Figure 15B An alternative embodiment of annulusoplasty system 1500 is shown, which utilizes a guide catheter 1505 as disclosed herein to guide annulusoplasty “on-line” (OTW) tool 1520 to treatment site 1555. Figure 15A As shown, the guiding catheter 1505 can first be guided to the treatment site 1555 in the heart wall. Figure 15B As shown, the OTW tool 1520 can then be precisely guided above (along the guide catheter 1505) to the treatment site 1555, thereby improving treatment accuracy while reducing the possibility of accidental contact. Therefore, the principles disclosed herein provide a simple, low-impact, and highly flexible approach to valve repair and replacement.

[0065] Therefore, this disclosure is not intended to be limited to the embodiments shown herein, but is given the widest scope consistent with the claims, the principles and novel features disclosed herein. The word "example" is used exclusively herein to mean "used as an example, illustration, or illustration." Any embodiment described herein as an "example" is not necessarily to be construed as preferred or advantageous over other embodiments unless otherwise stated.

[0066] Certain features described in the context of individual embodiments of this specification may also be applied in combination to a single embodiment. Conversely, various features described in the context of a single embodiment may also be applied individually or in any suitable sub-combination to multiple embodiments. Furthermore, although features may be described above as functioning in certain combinations and even initially claimed in this manner, one or more features from a claimed combination may be removed from that combination in some cases, and the claimed combination may be intended to provide sub-combinations or variations thereof. Similarly, although the operations in the drawings are described in a particular order, this should not be construed as requiring such operations to be performed in the specific order illustrated or in a sequential order, or to perform all illustrated operations to achieve the desired result. Furthermore, other embodiments are within the scope of the appended claims. In some cases, the operations stated in the claims may be performed in a different order and still achieve the desired result.

[0067] Those skilled in the art will understand that, in general, the words used herein are typically intended to be “open-ended” (e.g., the word “including” should be interpreted as “including but not limited to,” the word “having” should be interpreted as “at least having,” and the word “including” should be interpreted as “including but not limited to,” etc.). Those skilled in the art will also understand that if there is an intent to provide a specific number of adopted claim statements, that intent will be explicitly stated in the claims, and without such a statement, that intent does not exist. For example, to aid understanding, the appended claims below may contain the use of the introductory phrases “at least one” and “one or more” to introduce the claim statements. However, the use of such phrases should not be construed as indicating that the introduction of a claim statement using the indefinite articles "a" or "an" limits any specific claim statement containing the introduced claim to an embodiment containing only one of that statement, even when the same claim includes the introductory phrase "one or more" or "at least one" and indefinite articles such as "a" or "an" (e.g., "a" and / or "an") should generally be interpreted as meaning "at least one" or "one or more"); the same applies to the use of definite articles used to introduce claim statements. Furthermore, even if a specific number of introduced claim statements is explicitly stated, those skilled in the art will recognize that such a statement should generally be interpreted as indicating at least the stated number (e.g., the most basic statement of "two statements" without other modifiers generally indicates at least two statements, or more than two statements). Furthermore, when a provision similar to "at least one of A, B, and C, etc." is used, the structure is generally intended to employ the meaning of the agreement as would be understood by a person skilled in the art (e.g., "a system having at least one of A, B, and C" would include, but is not limited to, systems having A alone, B alone, C alone, A together with B, A together with C, B together with C, and / or A, B, and C together, etc.). When a provision similar to "at least one of A, B, or C, etc." is used, the provision is generally intended to employ the meaning of the agreement as would be understood by a person skilled in the art (e.g., "a system having at least one of A, B, or C" would include, but is not limited to, systems having A alone, B alone, C alone, A together with B, A together with C, B together with C, and / or A, B, and C together, etc.). It will be further understood by a person skilled in the art that any transitional words and / or phrases describing two or more alternative words (whether in the description, claims, or drawings) should be understood to cover the possibility of including one, any, or both of the words. For example, the phrase “A or B” will be understood as containing the possibility of “A” or “B” or “A and B”.

[0068] According to this disclosure, the apparatuses and / or methods disclosed herein and claimed herein can be made and implemented without excessive experimentation. While various embodiments of the apparatuses and methods of this disclosure have been described, it will be apparent to those skilled in the art that variations may be applied to these apparatuses and / or methods and steps, or the sequence of steps of the methods described herein, without departing from the concept, spirit, and scope of this disclosure. All such similar alternatives and modifications not apparent to those skilled in the art are considered to be within the spirit, scope, and concept of this disclosure as defined by the appended claims.

Claims

1. A system comprising: The guiding sheath has an inner lumen extending from the proximal end to the distal end and is configured to travel transluminally into the heart chambers, including the treatment site. A working catheter configured to translate longitudinally within the guide sheath to position the distal end of the working catheter at a position close to the distal end of the guide sheath, the working catheter including an axis having a distal end and a proximal end and a tissue engagement mechanism extending from the distal end of the axis; as well as A guiding catheter, translatably disposed within the working catheter, having a proximal and distal end and including a translation mechanism configured to allow the distal end of the guiding catheter to travel through the distal end of the working catheter to the treatment site, thereby providing a path for the working catheter to the treatment site. The distal end of the guiding catheter includes a distal end, which includes a distal guidewire anchor for securing to tissue at the treatment site. in: The guiding catheter can be advanced distally through the working catheter so that the distal end of the guiding catheter travels to the distal end of the working catheter, thereby securing the distal end of the guiding catheter to the tissue of the treatment site and providing the working catheter with a path to the treatment site; Once the distal end of the guide catheter is secured to the tissue at the treatment site, the working catheter can be translated over the guide catheter to a working position relative to the tissue at the treatment site, where the tissue engagement mechanism can engage with the tissue at the treatment site; and When the working catheter is in the working position and the distal end of the guide catheter is fixed relative to the tissue, the tissue engagement mechanism is movable between a first configuration and a second configuration relative to the axis of the working catheter. In the second configuration, the tissue engagement mechanism engages, contacts, and captures the tissue to repair or replace it.

2. The system of claim 1, wherein the translation mechanism is configured to drive the distal guidewire anchor into the tissue of the treatment site to secure the guide catheter to the treatment site.

3. The system of claim 2, wherein the distal guide wire anchor comprises at least one of a helical member, a clamping member, a hook member, or a needle member.

4. The system of claim 1 or 3, wherein the proximal end of the guide sheath further includes a steering controller coupled to the distal end of the guide sheath to guide the distal end of the guide sheath into the heart chamber.

5. The system of claim 3, wherein the working catheter is a valve annuloplasty catheter, which includes a tissue engagement mechanism at its distal end.

6. The system of claim 5, wherein the tissue engagement mechanism comprises at least one of a needle, hook, clamp, screw, frame, or anchor.

7. The system of claim 5, wherein the working catheter includes a tissue engagement control mechanism coupled to control the tissue engagement mechanism.

8. The system of claim 5, further comprising an implantable core slidably disposed within the working channel of the working catheter, the implantable core including at least one implantable component supported within the distal end of the implantable core.

9. The system of claim 8, wherein the implantation core includes at least one implant release mechanism disposed at the proximal end of the implantation core, configured to release at least one implantation component from the implantation core.

10. The system of claim 1 or 8 further includes a workbench structure comprising at least one of a guide sheath support, a working catheter support, or an implantation core support.

11. The system of claim 10, wherein the workbench structure includes a catheter seat including a track, and wherein the working catheter support is slidably disposed on the track of the catheter seat such that movement of the working catheter support along the track causes the working catheter to translate within the guide sheath.

12. The system of claim 1 or 8, wherein the translation mechanism is further configured to retract the guide conduit into the distal end of the working conduit.

13. The system of claim 1 or 8, further comprising a visualization mechanism positioned near the distal guide wire anchor.

14. The system of claim 13, wherein the guiding conduit includes the visualization mechanism.

15. The system of claim 13, wherein the visualization mechanism comprises an intracardiac ultrasound (ICE) sensor.

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