Patent Application
20210321996
This relates generally to devices, systems, and methods for performing catheter-based procedures on or in the heart, including but not limited to, devices, systems, and methods for performing catheter-based procedures on the left atrium and internal structures of the heart.
Heart disease has been the leading cause of death worldwide. Cardiac operations, such as cardiac surgery, cardiovascular surgery, and cardiothoracic surgery, are important (and sometimes the only available) treatment options for many heart diseases.
Traditionally, for cardiac operations, open heart surgeries were performed. Such operations typically involve cutting and opening the chest of a patient (e.g., via a median sternotomy or a thoracotomy approach). Open heart surgery typically includes making a 5-inch to 10-inch incision in the chest, surgical division of the patient's sternum (also called the breastbone), and also sometimes requires prying the rib cage apart. These procedures can be painful and very invasive, and often lead to medical complications which can slow down the recovery of the patient. In addition, patients who are in poor medical condition may not be eligible to receive open heart surgery due to the risks associated with such operations, thereby preventing the much-needed surgical treatment of heart disease.
Minimally-invasive heart surgeries have been developed to reduce the above-discussed issues associated with open heart surgery. In minimally-invasive heart surgeries, smaller incisions (e.g., 1-inch to 4-inch incisions) are made on the chest (e.g., a hemisternotomy incision or a mini-thoracotomy incision made at a location that corresponds to spacing between ribs of a patient, such as an intercostal space).
However, current minimally-invasive techniques often require sawing the sternum (e.g., hemisternotomy) or separating the ribs (e.g., right antero-lateral thoracotomy), which can lead to costochondral disarticulation and rib fractures. Minithoracotomy (e.g., right minithoracotomy), which is performed for mitral valve surgeries, involves making an incision on the chest and opening the pericardium. Video-assisted thoracoscopic (VATS) procedures may also involve placing instruments in the chest cavity between the ribs which can be painful. While less invasive than open heart surgery, even these procedures can be associated with significant complications that are undesirable and may not be tolerated by high risk patients. Further, most such approaches require the use of cardiopulmonary bypass to arrest the heart and lungs, making it possible to operate on a stopped heart. Cardiopulmonary (or heart-lung) bypass has its own significant risks and complications.
In the past two decades, catheter-based approaches for performing valve repair and replacement and other intracardiac procedures have been developed. These involve the introduction of a catheter into a peripheral artery or vein, and advancement of the catheter into the heart, where a prosthesis may be deployed or a repair procedure performed with the heart beating, avoiding the use of cardiopulmonary bypass. Such approaches have achieved widespread success in aortic valve replacement, where a catheter is introduced from a femoral artery into the aorta and a stented valve prosthesis is deployed at the native aortic valve position. In contrast, however, transcatheter approaches to mitral valve replacement or repair have proven far more difficult. Not only is the anatomy of the mitral valve much more complex than the aortic valve, but the endovascular routes to the mitral valve are circuitous and require navigation through tight turns and across the septum of the heart. Achieving the desired repair or replacement using a long, flexible, tightly-curved catheter has proven extremely challenging. Thus, while some simple transcatheter mitral procedures have gained adoption, more complex transcatheter procedures such as mitral replacement, annuloplasty, and chordal replacement are still far away from clinical viability.
In recent years, some surgeons have employed a trans-apical approach to perform mitral valve surgery on the beating heart, which, like transcatheter approaches, can eliminate the need for cardiopulmonary bypass. In this approach, a left mini-thoracotomy is created and an opening is made in the pericardium. An incision is made in the left ventricle of the heart near the apex to place a purse string suture or create a sealed access port through which instruments and/or prostheses can be introduced to perform mitral valve repair or replacement. While the trans-apical approach has the advantage of avoiding cardiopulmonary bypass and further allows the mitral valve to be reached through a much shorter, straighter path than endovascular approaches, it has been found that access through the left ventricle creates significant trauma to this critical left ventricular muscular chamber of the heart and can result in long-term impairment of ejection fraction and/or can cause scar tissue formation in the heart muscle. Further, controlling bleeding from the trans-apical incision is challenging both during and after the procedure due to the high blood pressure in the left ventricle, and the occurrence of bleeding-related complications has been undesirably high. Moreover, this approach requires pericardial access which adds risk and complexity. Therefore, many surgeons and cardiologists believe that the trans-apical approach is not a long-term solution for less-invasive mitral surgery.
Thus, there is a need for systems, methods, and devices that further reduce or eliminate complications associated with cutting, separating, and/or breaking the bones, incising the diaphragm, and/or incising the pericardium, which avoid incisions in the left ventricle, and which allow intra-cardiac procedures to be performed on the beating heart without the need for cardiopulmonary bypass.
Some or all of the above deficiencies and other problems associated with conventional cardiac surgical devices and methods may be reduced or eliminated by the disclosed devices and methods.
In a first embodiment, a method of performing an interventional procedure in a beating heart of a patient, the method comprises:
In exemplary embodiments, the procedural catheter is advanced through the mediastinum under visualization using a technique selected from echocardiography, fluoroscopy, and intravascular ultrasound.
In exemplary embodiments, the method further comprises placing an endoscopic access device through the suprasternal penetration into the mediastinum, wherein the procedural catheter is advanced through the mediastinum in a working channel of the endoscopic access device.
In exemplary embodiments, the method further comprises positioning an access sheath through the suprasternal penetration into at least a portion of the mediastinum, the procedural catheter being advanced through a lumen of the access sheath.
In exemplary embodiments the access sheath is positioned through the atrial dome into the left atrium, the procedural catheter being advanced through the lumen of the access sheath into the left atrium.
In exemplary embodiments, the interventional procedure is selected from mitral annuloplasty, chordal replacement, or mitral valve replacement.
In exemplary embodiments, the interventional procedure comprises pulmonary vein ablation or atrial ablation.
In exemplary embodiments, the interventional procedure comprises closure or occlusion of the left atrial appendage.
In exemplary embodiments, the method further comprises hemostatically sealing the puncture in the left atrial dome around the procedural catheter while performing the interventional procedure.
In another embodiment, the invention includes a method of performing an interventional procedure in a beating heart of a patient, the method comprising:
In exemplary embodiments, a tubular dilator is positioned in the inner lumen of the access catheter as it is slidably advanced into the left atrium with the guidewire extending through the dilator.
In exemplary embodiments, the interventional procedure is performed under visualization using a technique selected from echocardiography, fluoroscopy, and intravascular ultrasound.
In exemplary embodiments, the access catheter is advanced through the mediastinum using a technique selected from echocardiography, fluoroscopy, and intravascular ultrasound.
In exemplary embodiments, the interventional procedure is selected from mitral annuloplasty, chordal replacement, or mitral valve replacement.
In exemplary embodiments, the interventional procedure comprises pulmonary vein ablation or atrial ablation.
In exemplary embodiments, the interventional procedure comprises closure or occlusion of the left atrial appendage.
In exemplary embodiments, the method further comprises hemostatically sealing the puncture in the left atrial dome around the access catheter while performing the interventional procedure.
In exemplary embodiments, the method further comprises closing the puncture in the left atrial dome after the interventional procedure is performed.
In exemplary embodiments, closing the puncture comprises delivering a suture through tissue of the atrial dome with a closure device positioned through the access catheter.
In still other embodiments, the invention provides a system for performing an interventional procedure in a heart of a patient, comprising:
In exemplary embodiments, the system further comprises a tissue penetration device removably positionable in the inner lumen of the atrial access catheter and having a distal tip extendable therefrom configured to penetrate tissue of the atrial dome.
In exemplary embodiments, the tissue penetration device comprises a tubular needle.
In exemplary embodiments, the system further comprises a guidewire slidably positionable through the tubular needle.
In exemplary embodiments, the system further comprises a dilator removably positionable in the inner lumen of the atrial access catheter, the dilator having a passage therein configured to receive the guidewire.
In exemplary embodiments, the mediastinal access device comprises an imaging device for imaging the mediastinum.
In exemplary embodiments, the imaging device comprises an image sensor, optical channel, or a lens.
In exemplary embodiments, the procedural device comprises a mitral valve repair device.
In exemplary embodiments, the mitral valve repair device is configured to deliver a replacement chord.
In exemplary embodiments, the mitral valve repair device is configured to deliver and annuloplasty ring or band.
In exemplary embodiments, the procedural device comprises an ablation device.
In exemplary embodiments, the procedural device comprises a left atrial appendage occlusion or closure device.
In exemplary embodiments, the system further comprises a closure device positionable in the inner lumen of the atrial access catheter and configured to deliver a closure element for closing the puncture upon removal of the atrial access catheter.
All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.
The novel features of the present disclosures are set forth with particularity in the appended claims. For a better understanding of the features and advantages of the various described implementations, in which the principles of the present disclosure are utilized, reference should be made to the Detailed Description below, in conjunction with the following drawings in which like reference numerals refer to corresponding parts throughout the figures.
Like reference numerals refer to corresponding parts throughout the several views of the drawings. Drawings are not necessarily drawn to scale unless explicitly indicated otherwise.
Reference will now be made in detail to implementations, examples of which are illustrated in the accompanying drawings. In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the various described implementations. However, it will be apparent to one of ordinary skill in the art that the various described implementations may be practiced without these specific details. In other instances, well-known methods, procedures, components, circuits, and networks have not been described in detail so as not to unnecessarily obscure aspects of the implementations.
Many modifications and variations of this disclosure can be made without departing from its spirit and scope, as will be apparent to those skilled in the art. The specific implementations described herein are offered by way of example only, and the disclosure is to be limited only by the terms of the appended claims, along with the full scope of equivalents to which such claims are entitled. It will be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are explicitly contemplated herein.
Although certain embodiments and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses, and to modifications and equivalents thereof. Thus, the scope of the claims appended hereto is not limited by any of the particular embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain embodiments, however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components.
For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.
The mediastinum 120 is a central compartment of the thoracic cavity located between the lungs outside the pleural cavities, and which includes the heart, trachea, esophagus, and other major vessels. As outlined generally in
In some embodiments, the mediastinum 120 (e.g., the middle mediastinum) is accessed through the superior thoracic aperture (see e.g.
“Percutaneous catheters” or “percutaneous devices” as used in this disclosure are intended to mean diagnostic, visualization, or interventional catheters and other devices which are adapted to penetrate the skin and underlying tissues to gain access to a body cavity, organ, or vessel through a needle puncture or a very small penetration or incision. Usually the percutaneous catheters and devices will be of small profile, e.g. less than about 12 mm in diameter, and will be flexible and often steerable to allow the devices to be controlled from outside the body to access target structures on or within the heart while avoiding non-target vessels and other anatomical structures, typically requiring indirect visualization techniques such as fluoroscopy, ultrasound, or endoscopy. Conventional percutaneous techniques such as the Seldinger technique may be used to introduce the percutaneous catheters and devices of the invention into the mediastinum or other body cavities and lumens, but are not required.
In the embodiment of
It will be understood that there may be variations in the procedure. For example, the procedural catheter may be slidably advanced over a guidewire or a small diameter endoscope inserted through the suprasternal access site to assist in navigating through the mediastinum or in the heart, as described in more detail below. Alternatively, the procedural catheter may be inserted through the working channel of an endoscope or mediastinoscope which has first been advanced through the mediastinum to a position near the left atrial roof
In the embodiment of
In a third embodiment, summarized in the flowchart of
In a variation on the procedure outlined in
Referring now to
Introducer sheath 210 may optionally include a port or lumen (not shown) through which a gas such as carbon dioxide may be delivered into the mediastinum to inhibit air from entering the cavity. Introducer sheath 210 may also include a fluidic valve through which percutaneous device 400 may be introduced and which seals around the device to inhibit loss of gas, blood, or other fluids from the mediastinum.
Introducer sheath 210 may optionally be shaped or shapable into a curve or angle to direct percutaneous device 400 in the caudal or inferior direction parallel to the trachea. For example an axis of a distal extremity of introducer sheath 210 may be disposed at an angle of about 90-160° relative to the axis of a proximal extremity of the introducer sheath. Introducer sheath 210 may optionally have a region which is flexible or shapable to allow the user to adjust the relative angle of the distal and proximal extremities in situ.
As shown in
In some embodiments, the distal portion of the percutaneous device 400 may be advanced along a path substantially parallel to a plane containing a longitudinal access of the trachea 130.
In some embodiments, the distal portion of the percutaneous device 400 may be advanced along a path that is superficial to the pretracheal fascia 440. In some embodiments, the distal portion of the percutaneous device 400 may be advanced along a path that is deep to the pretracheal fascia 440. Distal dissection in this plane may lead to the subcarinal space SC inferior to the carina and superior to the left atrial dome or roof 504.
In some embodiments, the distal portion of the percutaneous device 400 may move (e.g. without puncturing or damaging) the right or left pulmonary artery 420 aside to reach the dome of the left atrium.
Although
The path through which the device traverses to reach the heart from the penetration site may for example have a length within a range of about 5 cm to about 25 cm, for example within a range of about 10 cm to about 25 cm, or within a range of about 5 cm to about 20 cm. For example, the path may be about 15 cm long.
In preferred embodiments, the percutaneous device 400 may be inserted from the suprasternal incision to the left atrium along a path that passes outside the trachea 130, aorta 410, right pulmonary artery 420, pericardium 702, and other vessels and structures within the mediastinum without entering, penetrating, cutting, puncturing, or otherwise injuring such vessels and structures (other than the left atrium). In some embodiments, the percutaneous device 400 may be introduced into the patient without accessing or penetrating the pleural cavities surrounding the lungs. By not penetrating the pleural cavities, the percutaneous device may avoid pneumothorax which can attend other approaches.
In preferred embodiments, at least a portion of the percutaneous device 400 is flexible and can bend into one or more curves along its length so as to extend around vessels and other structures disposed between the suprasternal access point and the left atrium. Percutaneous device 400 may further have a steerable or articulated distal portion to avoid one or more internal structures of the patient such as the trachea 130, esophagus 450, aorta 410, superior vena cava 720, aortic arch 780, carotid artery 782, innominate artery, left recurrent laryngeal nerve, pulmonary artery 420 and/or a primary bronchus 430 of the patient. Such steerability and/or articulation may also allow the percutaneous device to be positioned on or within the heart 110 at a desired location or angle. In some embodiments, an obturator is removably positionable within a channel of the percutaneous device to straighten and/or stiffen the device during introduction, e.g. to pass between tight anatomical structures or to bluntly dissect tissue.
The percutaneous device 400 may, for example, have a steerable distal end. The distal end may be configured to be steered during advancement to the atrium to align the distal end with a particular access point on the heart, for example an extrapericardial location on the roof of the left atrium. Alternatively or in combination, the distal end may be configured to be steered after being inserted into an internal chamber of the heart, e.g. to align a procedural device or prosthesis at a desired distance and/or angle relative to an internal structure of the heart, for example a mitral valve leaflet, mitral annulus, or papillary muscles, as further described below.
In some embodiments, the percutaneous device 400 is steered along the coronal plane, in addition to, or instead of, steering along the sagittal plane. For example, as shown in
In some embodiments, the percutaneous device 400 may be configured to fit within a working channel of an endoscopic access device such as an endoscope or mediastinoscope. Such endoscopic access devices are described in commonly assigned PCT Application No. PCT/US18/42171, which has been incorporated herein by reference. The endoscopic access device may be placed through a penetration in the suprasternal notch and advanced into the mediastinum. In some embodiments, the endoscopic access device may be advanced toward the heart 110 in the manner described herein with respect to the percutaneous device 400, e.g. inferiorly along the trachea 130 and between the aorta 410 and the trachea 130 and/or between the right pulmonary artery 420 and the trachea 130. Alternatively, the endoscopic access device may pass behind the aorta 410 and/or right pulmonary artery 420. The endoscopic access device may be advanced until a roof of the left atrium is visible through the optical channel, image sensor (CCD or CMOS chip) or lens of the endoscopic access device. The distal portion of the percutaneous device 400 may then be inserted into a working channel of the endoscopic access device. The distal portion of the percutaneous device 400 may be advanced towards the heart 110 through the working channel of the endoscopic access device. The distal portion of the percutaneous device 400 may be advanced from the distal end of the endoscopic access device to contact the cardiac wall of the heart 110, optionally while being visualized through the optical channel, image sensor, or lens of the endoscopic access device. The endoscopic access device may optionally be used to visualize the mediastinal cavity and/or the heart 110 of the patient while advancing the distal portion of the percutaneous device 400 toward the heart as described herein.
In some embodiments, the percutaneous device 400 may be configured to be slidingly coupled to and advanced over an endoscope. Preferably the endoscope will have a small profile, with a diameter of less than about 10 mm, more preferably a diameter of 5 mm or less, and will be steerable to allow steering around vessels and other structures of the mediastinum. The endoscope may be inserted through the suprasternal penetration and advanced to the left atrium in the manner described above. The structures and vessels of the mediastinum may be viewed with the endoscope while it is advanced to facilitate navigation and minimizing trauma. The endoscope may be advanced until the left atrium can be seen, or until the endoscope reaches the left atrial dome. The percutaneous device 400 may be configured to slidably couple to the endoscope, e.g. by passing the endoscope through a working channel of the percutaneous device 400. The distal portion of the percutaneous device 400 may be slidingly advanced towards the heart over the endoscope.
In some embodiments, the percutaneous device 400 may be configured to be inserted into the opening in the suprasternal notch by being advanced over a guidewire. The guidewire may first be inserted through the opening and advanced through the mediastinum to the left atrium along a path as described above with respect to the percutaneous device 400. In some embodiments, the guidewire may be a steerable guidewire. In some embodiments, the guidewire may be advanced until it contacts the roof of the left atrium of the heart 110. In some embodiments, the tip of the guidewire may be advanced through the roof of the left atrium into the interior of the left atrium. The guidewire may include a pressure transducer, ultrasound transducer, or other sensor (e.g. similar to sensor 530 described herein) configured to detect the location of the guidewire. The guidewire may include radiopaque materials or markers which can be seen using fluoroscopy to assist in navigation. The percutaneous device 400 may include a guidewire lumen, eyelet, tube, or the like configured to be slidably coupled to the guidewire. Alternatively, the guidewire may be passed through a working channel of the percutaneous device 400. The distal portion of the percutaneous device 400 may be advanced towards the heart 110 by sliding over the guidewire.
Various visualization techniques may be used to visualize the percutaneous devices of the invention within the mediastinum and heart. In some embodiments, percutaneous device 400 includes radiopaque markers at certain locations in the distal portion thereof to facilitate visualization using fluoroscopy. Radiopaque dyes or fillers may also be included in the materials used to construct percutaneous device 400. Further, fluoroscopic navigation aids may be used in conjunction with percutaneous device 400, such as the use of radiopaque markers on a tracheal tube placed in the patients' trachea during the procedure. In this way the position of markers on the percutaneous device 400 may be viewed relative to the tracheal tube markers to establish its position in the mediastinum. Similarly, an esophageal tube with markers could be placed in the esophagus during the procedure.
Additionally or alternatively, echocardiography may be used for visualization. Transesophageal echocardiography (TEE) can be used for visualization of the percutaneous device in the mediastinum inferior to the trachea as well as in the heart. An ultrasound transducer may also be placed in the trachea, e.g. incorporated into a tracheal tube, to allow echocardiographic visualization of the percutaneous device as it is advanced along the anterior side of the trachea. Three dimensional echocardiography is particularly preferred for highly detailed visualization. Moreover, the percutaneous device itself may include an ultrasound transducer in the distal tip thereof similar to an intravascular ultrasound (IVUS) catheter to allow ultrasonic visualization as the device is inserted.
In some embodiments, percutaneous device 400 may comprise an access device configured to penetrate the atrial wall to provide an access channel into the left atrium.
As shown in
In some embodiments, access device 520 includes a sensor 530 at its distal tip. Sensor 530 can be configured to determine whether the access device is in contact with the cardiac wall. The sensor may comprise a proximity sensor, capacitive sensor, contact sensor, infrared sensor, audio sensor, ultrasound transducer, or other known type of sensor.
The access device 520 may be configured to form a penetration (e.g. make an incision, puncture, or the like) at a target location in the wall of the heart to allow access into selected chambers of the heart. In specific embodiments the chamber is an atrium, more preferably the left atrium. In particularly preferred embodiments, an atrial penetration is made in the roof or dome 504 of the left atrium without penetrating the pericardium of the heart 110 or entering pericardial cavity or sac (referred to herein as an extrapericardial penetration, extrapericardial puncture, an extrapericardial incision). Such an extrapericardial penetration may avoid complications of conventional trans-pericardial surgical approaches such as unintentional injury to the heart wall and/or pericarditis. Additionally dome 504 of the left atrium 502 is relatively immobile, which may make it easier to form a penetration at that location during beating heart procedures in comparison to, for example, the left ventricle which is entered in trans-apical procedures. Further, by eliminating the need to penetrate or open the pericardium, the need for specialized techniques and instruments for entering the pericardium safely may be obviated.
In some embodiments, an atrial penetration may be formed while the heart is beating. In some embodiments, the atrial penetration may be formed while the heart is slowed. In some embodiments, the atrial penetration may be formed while the heart is stopped. In some embodiments, the atrial penetration may be formed when the heart is on cardiopulmonary bypass.
In stopped heart procedures, a patient may be placed on cardiopulmonary bypass without incisions in the chest by placing an endoaortic occlusion catheter into a femoral or iliac artery and advancing it into the ascending aorta, where a balloon may be expanded to occlude the aorta as will be known to one of ordinary skill in the art. A femoral venous cannula may be used to withdraw blood from the patient and deliver it to an external oxygenator and pump, from which blood may be returned to the patient via a femoral arterial cannula as will be known to one of ordinary skill in the art.
Referring now to
As shown in
It will be understood that in some embodiments dilator 525 may not be necessary. For example, access device 520 may be configured with a rounded or tapered tip to facilitate introduction directly over hollow needle 521 and/or wire 523.
Due to the relatively low left atrial pressure and the tight fit of access device 520 in the penetration in the left atrial wall, hemostasis may in some cases be adequate without taking other steps to seal the penetration around access device 520. In other situations, it may be desirable to enhance such sealing. Various means may be used to provide hemostatic sealing around access device 520. In one embodiment, a purse-string suture may be placed in the left atrial wall around the penetration through which access device 520 extends. Such purse-string suture is preferably placed prior to introduction of access device 520. One example of an endoscopic device suitable for placement of such a purse-string suture is disclosed in commonly assigned PCT Application Serial No. PCT/US2019/012538, filed Jan. 7, 2019, (Attorney Docket No. 54513-704.601), the disclosure of which is incorporated herein by reference.
Alternatively, other types of endoscopic devices may be used to create a hemostatic seal around the atrial penetration prior to introduction of access device 520. For example, an endoscope may be inserted through introducer sheath 210 and advanced to the left atrial dome in the manner described above. A suturing device may then be inserted through the working channel of the endoscope to place one or more sutures in the left atrial wall adjacent to or around the site at which access device 520 is to be inserted. The suture ends may be withdrawn from the mediastinum through introducer sheath 210 and, following introduction of access device 520 into the left atrium, cinched in order to tightly seal the atrial penetration around access device 520. Following removal of atrial access device 520, such sutures may be tied to close the atrial penetration.
In other embodiments, access device 520 may itself include means for sealing the atrial penetration to establish hemostasis. For example, access device 520 may include an inflatable balloon or mechanically expandable flange around its periphery in a distal region thereof configured to engage the interior atrial wall around the penetration, as disclosed in the aforementioned PCT Application No. PCT/US18/42171, which has been incorporated herein by reference. Such patent application also discloses various mechanisms for deploying needles and sutures from a left atrial access device for purposes of both sealing and closing an atrial penetration, any of which may be incorporated into access device 520. Other access devices incorporating penetration closure devices are described below in connection with
The access device 520 may, for example, have an outer diameter of about 3 mm to about 20 mm, usually about 3 mm to about 15 mm, and more preferably about 3 mm to about 10 mm. The access device 520 may have a length of about 5 cm to about 60 cm from the proximal end to the distal end, usually about 10 cm to about 40 cm, and preferably about 15 cm to about 30 cm.
The access device 520 may comprise a channel 540 extending therethrough from a proximal end of the access device 520 to a distal end of the access device 520. The channel may be defined by an inner wall of the access device 520 having an inner diameter. In some embodiments, the access device 520 may comprise a cannula, sheath, or tube. The channel may have a diameter of about 1 mm to about 12 mm, usually about 1 mm to about 10 mm, or more preferably about 2 mm to about 8 mm.
In some embodiments, channel 540 of the access device 520 may be configured to allow one or more additional members to be slidably and/or removably disposed therein. The access device 520 may, for example, be configured to allow one or more of a penetration device, a closure device, a sealing device, a procedural device, a visualization device, a prosthesis delivery device, and/or a suturing device to access the left atrium 504 as described herein. In some embodiments, the access device may include an internal sealing element to inhibit blood loss through the channel therein. The internal sealing element may comprise a hemostatic valve disposed in the channel and configured to inhibit blood loss therethrough. The hemostatic valve may comprise, for example, a duck bill valve, a diaphragm valve, a touhy-borst valve, or a three leaflet valve.
Access device 520 may optionally comprise an anchoring element (not shown) coupled to a proximal portion thereof configured to be positioned either externally or in the mediastinum near the suprasternal access site. The anchoring element may be configured to inhibit movement of access device 520 relative to the patient to prevent inadvertent removal of the percutaneous device from the heart through the atrial penetration, or inadvertent advancement toward or within the heart beyond a desired distance. The anchoring element may comprise a ring, flange, laterally-extending handles or wing-like elements, or other suitable structure on the proximal portion of the access device configured to engage the patient's body, surgical drapes, or other material adjacent the suprasternal opening. Alternatively, the anchoring element may comprise a mechanical arm attachable to access device 520 and coupled to a stationary structure such as the operating table.
Access device 520 may optionally comprise a retention element coupled to a distal portion thereof. The retention element may be configured to prevent inadvertent removal of the access device through the atrial penetration. In some embodiments, the retention element may comprise a flange, a ring, an expandable wire basket, deployable wing-like elements, or a balloon. The retention element may have an undeployed configuration to aid in advancement of the device to the heart and through the atrial wall, and a deployed configuration configured to resist inadvertent removal of the elongate member from a cardiac wall of the patient.
Referring to
Once access device 520 is positioned at the desired location in the left atrium, a procedural catheter 524 can be inserted through a channel of access device 520 into the left atrium in order to perform a procedure within the heart. The procedure may comprise at least one of mitral valve replacement, mitral valve repair, mitral annuloplasty, chordal repair, chordal replacement, leaflet resection, mitral replacement, leaflet coaptation, papillary repair, or papillary coaptation. The procedure may alternatively comprise at least one of atrial appendage closure, atrial ablation, pulmonary vein ablation, septal defect closure, aortic valve repair, aortic valve replacement, tricuspid valve repair, tricuspid valve replacement, implantable cardiac defibrillator (ICD) implantation, pacemaker implantation, or placement of leads for ICD's or pacemakers, myocardial biopsy, or septectomy.
Similar to access device 520, procedural catheter 524 will be adapted for visualization using fluoroscopy, TEE, transthoracic echocardiography or other indirect visualization technique. Procedural catheter 524 may be composed of radiopaque or echogenic materials, and/or include radiopaque or echogenic markers at one or more locations along its length. Such markers can be viewed in relation to the position of markers on access device 520, on guidewire 523, or on other devices such as a tracheal tube or an esophageal probe to assist in positioning. Procedural catheter 524 may further have lumens, chambers, or inflatable elements that can be filled with radiopaque fluid. Alternatively, procedural catheter 524 may be configured to inject radiopaque dye into the mediastinum or heart during the procedure to facilitate visualization of its location.
While access device 520 is preferably steerable as previously described, alternatively or additionally procedural catheter 524 may have a steerable distal portion. Providing steerability in both access device 520 and procedural catheter 524 allows highly precise multi-axis positioning of a distal end of procedural catheter 524 to facilitate various interventional procedures. Various known mechanisms may be used to enable such steerability, such as steering wires extending slidably through one or more lumens in procedural catheter 524 and secured at its distal tip. Such wires can be tensioned to bend procedural catheter 524 around one or more axes using a control mechanism at the proximal end of the catheter.
In an exemplary embodiment, the procedure is mitral annuloplasty, as illustrated in
Suture anchor 529 may have a variety of configurations. In an exemplary embodiment, suture anchor 529 comprises a helical coil adapted to be rotationally driven into the annulus. One embodiment of a device for delivering such a helical suture anchor is described in connection with
Under fluoroscopic visualization and/or TEE, access device 520 is then steered to another location along the mitral annulus, and procedural catheter 524, loaded with another suture anchor 529B, may be inserted through access device 520, as shown in
Referring to
Sutures 531 are then tightened and secured using knots or other devices. In one embodiment, knots are tied in each pair of suture extremities 531 outside the patient's chest, and an elongated flexible knot pushing device (not shown) is used to push each knot through access device 520 to engage annuloplasty band 533. The suture ends are then trimmed using a trimming catheter (not shown). Alternatively, a catheter 537 adapted to deploy crimpable fasteners similar to the Cor-Knot™ device may be used to secure and trim the sutures, leaving the annuloplasty ring 533 securely anchored in place, as shown in
In another embodiment, procedural catheter 524 comprises a chordal repair catheter 820 configured to perform replacement of chordae tendineae, as illustrated in
In an exemplary embodiment, illustrated in
Leaflet anchor 834 comprises a radially collapsible and expandable retainer 842 that in exemplary embodiments has a plurality of radial spokes 844, coupled to a cylindrical central hub 846, as shown in
Referring to
Chordal replacement catheter 820 is preferably steerable (in addition to access device 520) to facilitate steering the distal tip thereof into engagement with leaflet 516. Known catheter steering mechanisms may be used for this purpose. In preferred embodiments, chordal replacement catheter is configured to be positioned from a suprasternal access site into the left atrium, through the mitral valve, around the edge of a mitral leaflet, and into engagement with a downstream or ventricular surface of the leaflet, as shown in
Referring to
As shown in
A handle 890 is coupled to the proximal end of outer shaft 882, as shown in
Referring again to
Replacement chord 830 is then adjusted and secured. In an exemplary embodiment, shown in
Before finally securing replacement chord 830 it is adjusted in length and tension to achieve optimal valve function and minimize mitral regurgitation. While observing the mitral valve using TEE and/or fluoroscopy, replacement chord 830 may be tensioned by the operator until regurgitation is minimized. The operator then actuates crimping catheter 902 to simultaneously crimp crimping device 900 and trim off the free end of replacement chord 930. Crimping catheter 902 is then removed from the patient, leaving the completed repair shown in
The foregoing process may be repeated to place multiple replacement chords 830 as needed.
Valve delivery catheter 1020 may comprise a sheath 1021 or capsule in a distal region thereof configured to hold a prosthetic mitral valve 1030 (shown in
Once the distal end of the valve delivery catheter 1020 has been advanced into the desired position and/or orientation, the sheath may be retracted and the prosthetic mitral valve 1030 may be released (as shown in
After accessing the internal chamber of the heart and/or preforming one or more cardiac procedure therein, the distal portion of the percutaneous device may be removed from the heart and the atrial penetration may then be closed. Any of the percutaneous devices or systems described herein may optionally comprise a closure device.
In some embodiments, the atrial penetration may be closed by cinching a purse string suture placed circumferentially around the atrial penetration as described herein.
In some embodiments, the atrial penetration may be closed with the aid of one or more closure device (also referred to herein as a suturing device) as described herein. An exemplary embodiment of such a closure device is illustrated in
A needle assembly 1122 is disposed in outer shaft 1112 between catchers 1118 and is axially movable relative thereto. Needle assembly 1122 has an inner shaft 1123 having a distal end 1124 to which a pair of needle arms 1126 is coupled. Needle arms 1126 have arm ends 1128 pointing in a proximal direction relative to outer shaft 1112 and are deflectable from an inward position in which they are contained within outer shaft 1112, shown in
As shown in
Closure device 1110 may be introduced through access device 520 into the left atrium, or directly introduced through an atrial penetration. If introduced through access device 520, once distal end 1116 is positioned in the left atrium, access device 520 may be retracted from the atrial penetration, leaving only closure device 1110 therein. As shown in
Needle assembly 1122 is then retracted proximally relative to outer shaft 1112, driving needle tips 1134 through the atrial wall and through mesh 1121 of catchers 1118, as shown in
With needle tips 1134 passed completely through mesh 1121, needle assembly 1122 is moved distally relative to outer shaft 1112. This decouples needle arms 1126 from needle tips 1134, which are retained in mesh 1121 by flanges 1142. As shown in
In an alternative embodiment, not shown, an additional tubular external shaft is slidably disposed over outer shaft 1112, and catchers 1118 are coupled to the distal end of this second external shaft. In this way, catchers 1118 remain outside outer shaft 1112 while they are withdrawn from the mediastinum using the external shaft, leaving one extremity of each suture 1144 outside outer shaft 1112 while the other extremity is within outer shaft 1112.
As shown in
It will be appreciated that, while closure device 1110 may be placed through access device 520 to close the atrial penetration following a procedure, closure device 1110 may alternatively be used in place of access device 520 to provide a channel through which a procedural catheter 524 or other device may be inserted into the heart. In such embodiments, needle assembly 1122 and catchers 1118 are initially removed from outer shaft 1112 and replaced with a needle, obturator and guidewire assembly similar to that described above in connection with
In some embodiments, access device 520 and/or procedural catheter 524 may be coupled to a robotic manipulator disposed outside a chest of the patient. The robotic manipulator may, for example, comprise a robotic arm positioned above the suprasternal opening 202. Alternatively, a portion of the robotic manipulator may be disposed inside a chest of the patient. The robotic manipulator may be controlled by an operator working at a remote-control console. Procedural catheters 524 having procedure-specific end-effectors maybe advanced through the channel of the access device 520 and manipulated by the robotic manipulator to carry out the desired procedure in the internal chamber of the heart 110.
In some embodiments, a percutaneous device kit may comprise one or more devices described herein disposed within a sealed sterile package. The kit may comprise an access device 520 and a procedure catheter 524 in a sealed sterile package. The kit may further comprise any of the devices or elements described herein, or any of combination of the devices or elements described herein.
The terminology used in the description of the various described implementations herein is for the purpose of describing particular implementations only and is not intended to be limiting. As used in the description of the various described implementations and the appended claims, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will also be understood that the term “and/or” as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items. It will be further understood that the terms “includes,” “including,” “comprises,” and/or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.
The foregoing description, for purpose of explanation, has been described with reference to specific implementations. However, the illustrative discussions above are not intended to be exhaustive or to limit the scope of the claims to the precise forms disclosed. Many modifications and variations are possible in view of the above teachings. The implementations were chosen in order to best explain the principles underlying the claims and their practical applications, to thereby enable others skilled in the art to best use the implementations with various modifications as are suited to the particular uses contemplated.
While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.
This application is a continuation of PCT Application No. PCT/US20/13369 (Attorney Docket No. 54513-706.601), filed Jan. 13, 2020, which claims the benefit of U.S. Provisional Application No. 62/791,510 filed Jan. 11, 2019, the entire content of which are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62791510 | Jan 2019 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US20/13369 | Jan 2020 | US |
| Child | 17364692 | US |
