Patent Grant
12226602
This application is a national phase application under 35 U.S.C. § 371 of PCT/IB2020/053118, filed Apr. 2, 2020, which claims the benefit of priority of U.S. patent application Ser. No. 16/374,698, filed Apr. 3, 2019, the entire contents of each of which are incorporated herein by reference.
This application generally relates to devices and methods for delivering implantable devices to the atrial septum, particularly in subjects with heart pathologies such as pulmonary arterial hypertension (PAH), congestive heart failure (CHF) or myocardial infarction (MI).
Pulmonary arterial hypertension occurs when the pressure within the blood vessels and lungs becomes too high. PAH may be caused by obstruction in the arties in the lung such as the development of scar tissue in the blood vessels of the lungs, but in many cases, the cause is unknown. Under normal conditions, the pressure within the right side of the heart and the blood vessels of the lungs is lower than the rest of the body which maximizes oxygenation of the blood in the lungs. With PAH, the heart must work harder under greater pressure to pump blood through the arteries in the lungs, weakening the heart muscles over time. As a result, the heart may be unable to sufficiently pump blood to the lungs to be oxygenated to keep the body functioning normally.
Heart failure is the physiological state in which cardiac output is insufficient to meet the needs of the body or to do so only at a higher filling pressure. There are many underlying causes of HF, including myocardial infarction, coronary artery disease, valvular disease, hypertension, and myocarditis. Chronic heart failure is associated with neurohormonal activation and alterations in autonomic control. Although these compensatory neurohormonal mechanisms provide valuable support for the heart under normal physiological circumstances, they also play a fundamental role in the development and subsequent progression of HF.
For example, one of the body's main compensatory mechanisms for reduced blood flow in HF is to increase the amount of salt and water retained by the kidneys. Retaining salt and water, instead of excreting it via urine, increases the volume of blood in the bloodstream and helps to maintain blood pressure. However, the larger volumes of blood also cause the heart muscle, particularly the ventricles, to become enlarged. As the heart chambers become enlarged, the wall thickness decreases and the heart's contractions weaken, causing a downward spiral in cardiac function. Another compensatory mechanism is vasoconstriction of the arterial system, which raises the blood pressure to help maintain adequate perfusion, thus increasing the load that the heart must pump against.
In low ejection fraction (EF) heart failure, high pressures in the heart result from the body's attempt to maintain the high pressures needed for adequate peripheral perfusion. However, as the heart weakens as a result of such high pressures, the disorder becomes exacerbated. Pressure in the left atrium may exceed 25 mmHg, at which stage fluids from the blood flowing through the pulmonary circulatory system transudate or flow out of the pulmonary capillaries into the pulmonary interstitial spaces and into the alveoli, causing lung congestion and, if untreated, the syndrome of acute pulmonary edema and death.
Table 1 lists typical ranges of right atrial pressure (RAP), right ventricular pressure (RVP), left atrial pressure (LAP), left ventricular pressure (LVP), cardiac output (CO), and stroke volume (SV) for a normal heart and for a heart suffering from HF. In a normal heart beating at around 70 beats/minute, the stroke volume needed to maintain normal cardiac output is about 60 to 100 milliliters. When the preload, after-load, and contractility of the heart are normal, the pressures required to achieve normal cardiac output are listed in Table 1. In a heart suffering from HF, the hemodynamic parameters change (as shown in Table 1) to maintain peripheral perfusion.
HF is generally classified as either systolic heart failure (SHF) or diastolic heart failure (DHF). In SHF, the pumping action of the heart is reduced or weakened. A common clinical measurement is the ejection fraction, which is a function of the blood ejected out of the left ventricle (stroke volume) divided by the maximum volume in the left ventricle at the end of diastole or relaxation phase. A normal ejection fraction is greater than 50%. Systolic heart failure generally causes a decreased ejection fraction of less than 40%. Such patients have heart failure with reduced ejection fraction (HFrEF). A patient with HFrEF may usually have a larger left ventricle because of a phenomenon called “cardiac remodeling” that occurs secondary to the higher ventricular pressures.
In DHF, the heart generally contracts normally, with a normal ejection fraction, but is stiffer, or less compliant, than a healthy heart would be when relaxing and filling with blood. Such patients are said to have heart failure with preserved ejection fraction (HFpEF). This stiffness may impede blood from filling the heart and produce backup into the lungs, which may result in pulmonary venous hypertension and lung edema. HFpEF is more common in patients older than 75 years, especially in women with high blood pressure.
Both variants of HF have been treated using pharmacological approaches, which typically involve the use of vasodilators for reducing the workload of the heart by reducing systemic vascular resistance, as well as diuretics, which inhibit fluid accumulation and edema formation, and reduce cardiac filling pressure. No pharmacological therapies have been shown to improve morbidity or mortality in HFpEF whereas several classes of drugs have made an important impact on the management of patients with HFrEF, including renin-angiotensin antagonists, beta blockers, and mineralocorticoid antagonists. Nonetheless, in general, HF remains a progressive disease and most patients have deteriorating cardiac function and symptoms over time. In the U.S., there are over 1 million hospitalizations annually for acutely worsening HF and mortality is higher than for most forms of cancer.
In more severe cases of HFrEF, assist devices such as mechanical pumps are used to reduce the load on the heart by performing all or part of the pumping function normally done by the heart. Chronic left ventricular assist devices (LVAD), and cardiac transplantation, often are used as measures of last resort. However, such assist devices typically are intended to improve the pumping capacity of the heart, to increase cardiac output to levels compatible with normal life, and to sustain the patient until a donor heart for transplantation becomes available. Such mechanical devices enable propulsion of significant volumes of blood (liters/min), but are limited by a need for a power supply, relatively large pumps, and pose a risk of hemolysis, thrombus formation, and infection. Temporary assist devices, intra-aortic balloons, and pacing devices have also been used.
Various devices have been developed using stents to modify blood pressure and flow within a given vessel, or between chambers of the heart Implantable interatrial shunt devices have been successfully used in patients with severe symptomatic heart failure. By diverting or shunting blood from the left atrium (LA) to the right atrium (RA), the pressure in the left atrium is lowered or prevented from elevating as high as it would otherwise (left atrial decompression). Such an accomplishment would be expected to prevent, relieve, or limit the symptoms, signs, and syndromes associated of pulmonary congestion. These include severe shortness of breath, pulmonary edema, hypoxia, the need for acute hospitalization, mechanical ventilation, and death.
Percutaneous implantation of interatrial shunts generally requires transseptal catheterization immediately preceding shunt device insertion. The transseptal catheterization system is placed from an entrance site in the femoral vein, across the interatrial septum in the region of fossa ovalis (FO), which is the central and thinnest region of the interatrial septum. The FO in adults is typically 15-20 mm in its major axis dimension and <3 mm in thickness, but in certain circumstances may be up to 10 mm thick. LA chamber access may be achieved using a host of different techniques familiar to those skilled in the art, including but not limited to: needle puncture, stylet puncture, screw needle puncture, and radiofrequency ablation. The passageway between the two atria is dilated to facilitate passage of a shunt device having a desired orifice size. Dilation generally is accomplished by advancing a tapered sheath/dilator catheter system or inflation of an angioplasty type balloon across the FO. This is the same general location where a congenital secundum atrial septal defect (ASD) would be located.
Moreover, devices such as those described in U.S. Pat. No. 5,312,341 to Turi, have been theorized for transseptal catheterization. Specifically, these devices have a retaining means such as an inflatable balloon that is inflated within the left atrium of the patient to prevent inadvertent retraction of the distal tip of the sheath from the left atrium during subsequent portions of the catheterization procedure.
In view of the foregoing, it would be desirable to provide devices for delivering implantable devices to the atrial septum of the heart to reduce left atrial pressure.
It would further be desirable to provide devices and methods for controlled positioning and delivery of atrial shunt devices.
The present invention overcomes the drawbacks of previously-known devices by providing apparatus for delivering a device for regulating blood pressure between a patient's left atrium and right atrium. The delivery apparatus includes a sheath having a distal region sized and shaped for percutaneous advancement to the atrial septum, a proximal region, and a sheath lumen extending therethrough, the sheath lumen sized and shaped to receive the shunt in a contracted delivery state. The apparatus also includes a first, outer catheter moveably disposed within the sheath lumen, wherein the first catheter has a first catheter lumen extending therethrough, and a hub moveably disposed within the sheath lumen distal to the first catheter.
The hub has a hub lumen extending therethrough and one or more engagers sized and shaped to releaseably engage the shunt in the contracted delivery state within the sheath lumen. The hub may include an engagement portion and a ring portion, wherein the engagement portion of the hub has a diameter smaller than a diameter of the ring portion, and wherein the one or more engagers are disposed circumferentially around the engagement portion of the hub. For example, a first expandable end of the shunt may be positioned between the one or more engagers and the ring portion and between an outer surface of the engagement portion and an inner wall of the sheath in the contracted delivery state within the sheath lumen. The hub further may include a proximal portion, such that the first catheter has a cavity sized and shaped to receive at least a portion of the proximal portion to limit movement of the hub relative to the first catheter.
In addition, the apparatus further includes a second, inner catheter moveably disposed within the first catheter lumen and the hub lumen, and wherein the first catheter and the hub are movable which the second catheter remains in place. The second catheter may include a stop, e.g., a lock ring, disposed at a distal end of the second catheter, such that the hub has a cavity sized and shaped to receive at least a portion of the stop to limit movement of the hub relative to the second catheter. In addition, the second catheter may include a guidewire lumen extending therethrough sized and shaped to receive a guidewire.
The apparatus also includes a handle disposed at the proximal region of the sheath. The first catheter, the hub, and the second catheter are independently movable relative to the sheath responsive to actuation at the handle to facilitate transition of the shunt from the contracted delivery state to an expanded deployed state at the atrial septum. In addition, the handle includes a knob that when actuated facilitates deployment of and/or halfway retrieval of the shunt at the atrial septum by adjusting a length of the delivery apparatus relative to the sheath. For example, the knob may be actuated to gradually adjust the length of the delivery apparatus relative to the sheath to assist in halfway retrieval of the shunt.
The handle may include a first actuator, the first actuator coupled to the sheath such that actuation of the first actuator causes the sheath to move relative to the hub, the first catheter, and the second catheter. The handle also may include a second actuator, the second actuator coupled to the second catheter such that actuation of the second actuator causes the second catheter to move relative to the sheath, the hub, and the first catheter. For example, the second actuator may be coupled to the second catheter via one or more guiderails and a pusher plate. Accordingly, the first actuator may move along the one or more guiderails within a housing of the handle.
The apparatus also includes a locking mechanism for releasably coupling the hub and the first catheter. Thus, the handle further includes a third actuator operatively coupled to the locking mechanism such that actuation of the third actuator causes the locking mechanism to couple or decouple the hub and the first catheter. The handle further may include an actuation ring positioned between the second actuator and the third actuator, wherein the actuation ring has an indented distal edge sized and shaped to engage with a toothed proximal edge of the third actuator, and a grooved proximal edge sized and shaped to engage with an indented distal edge of the second actuator. For example, actuation of the third actuator may orient the actuation ring such that actuation of the second actuator is inhibited.
In accordance with another aspect of the invention, a method for delivering a shunt at an atrial septum of a patient is provided. The method includes selecting a sheath and a delivery apparatus including a first, outer catheter, a hub distal to and releasably coupled to the first catheter, the hub having one or more engagers disposed thereon, the one or more engagers sized and shaped to releasably engage with the shunt in a contracted delivery state within a lumen of the sheath, and a second, inner catheter extending through a center lumen of the first catheter and the hub. The first catheter, the hub, and the second catheter are independently moveable relative to the sheath upon actuation of a handle operatively coupled to the sheath and the delivery apparatus.
The method further includes advancing a distal end of the sheath through the atrial septum into a first atrium, and then advancing the delivery apparatus within the lumen of the sheath, and actuating the handle to move the delivery apparatus distally relative to the sheath such that a first expandable end of the shunt extends distally out the distal end of the sheath and transitions from a contracted state within the lumen of the sheath to an expanded state in the first atrium. The method then includes (1) actuating the handle to move the second catheter distally relative to the sheath, the first catheter, and the hub; (2) moving the delivery apparatus and the sheath proximally until the first expandable end of the shunt rests against the atrial septum from within the first atrium; and (3) actuating the handle to decouple the hub and the first catheter. The method further includes moving the first catheter and the sheath proximally relative to the hub to disengage a second expandable end of the shunt with the one or more engagers of the hub and expose the second expandable end of the shunt from the sheath to transition from the contracted state within the lumen of the sheath to an expanded state in a second atrium. Finally, the method includes removing the sheath and the delivery apparatus from the patient such that a neck region of the shunt is positioned within the atrial septum to permit blood to flow through an opening in the neck region of the shunt and thereby through the atrial septum.
In accordance with one aspect of the invention, the method further includes actuating the handle to adjust a length of the delivery apparatus relative to a length of the sheath prior to disengaging the second expandable end of the shunt with the one or more engagers of the hub to assist in halfway retrieval of the shunt. For example, the handle may be actuated to gradually adjust the length of the delivery apparatus relative to the length of the sheath to facilitate retrieving the shunt in a partially deployed state. In accordance with yet another aspect of the invention, the second catheter includes a guidewire lumen extending therethrough sized and shaped to receive a guidewire, such that the method also includes inserting a guidewire percutaneously through the atrial septum into the first atrium. Thus, advancing the delivery apparatus through the sheath includes advancing the delivery apparatus over the guidewire. As will be understood by a person ordinarily skilled in the art, a dilator may be advanced over the guidewire through the fossa ovalis to enlarge the opening within the atrial septum, and removed prior to advancing the sheath and the delivery apparatus within the lumen of the sheath over the guidewire.
In accordance with another aspect of the present invention, a system for retrieving a shunt implanted in an atrial septum of a patient is provided. The system includes a sheath having a proximal end, a distal end, and a lumen extending therebetween. The system further includes one or more grappling hooks slidably movable through the lumen of the sheath. The one or more grappling hooks are transitionable between a contracted delivery state within the lumen of the sheath and an expanded deployed state when exposed from the distal end of the sheath. In addition, the one or more grappling hooks each have a hook portion that may be coupled to a proximal end of the shunt in the expanded deployed state. Accordingly, when the one or more grappling hooks are coupled to the shunt, transition of the one or more grappling hooks from the expanded deployed state to the contracted delivery state causes the proximal end of the shunt to transition from an expanded deployed state to a collapsed retrieval state. Moreover, the sheath is sized and shaped to receive the proximal end of the shunt in the collapsed retrieval state and may be moved over the shunt to transition a distal end of the shunt from an expanded deployed state to a collapsed retrieval state, to thereby retrieve the shunt from the atrial septum.
In one embodiment, the one or more grappling hooks are biased toward the expanded deployed state. Accordingly, the system further may include a restraint slidably movable over the one or more grappling hooks to transition the one or more grappling hooks between the contracted delivery state and the expanded deployed state. For example, the one or more grappling hooks may have a non-expandable catheter portion proximal to the hook portion, such that movement of the restraint towards the non-expandable catheter portion causes the one or more grappling hooks to transition from the contracted delivery state to the expanded deployed state, and movement of the restraint towards the hook portion causes the one or more grappling hooks to transition from the expanded deployed state to the contracted delivery state.
In another embodiment, the one or more grappling hooks are biased toward the contracted delivery state. Accordingly, the system further may include a balloon catheter slidably movable within the lumen of the sheath. The balloon catheter includes a balloon transitionable from a deflated state to an inflated state adjacent the proximal end of the shunt, thereby creating a ramp in the inflated state such that movement of the one or more grappling hooks over the balloon in the inflated state causes the one or more grappling hooks to transition from the contracted delivery state to the expanded deployed state.
In accordance with another aspect of the present invention, a system for loading a shunt for intravascular delivery to an atrial septum of a patient is provided. The system may include a proximal loader having proximal end, a distal end, and a lumen extending therebetween. For example, a proximal portion of the lumen may be sized and shaped to receive a proximal end of the shunt in a collapsed delivery state, and a distal portion of the lumen may be sized and shaped to transition the proximal end of the shunt from an expanded deployed state to the collapsed delivery state when the proximal end of the shunt is received through the distal portion of the lumen. In addition, the system further may include a distal loader having a cavity sized and shaped to receive the proximal loader therein. For example, movement of the proximal loader distally within the cavity of the distal loader may cause the proximal end of the shunt positioned within the cavity of the distal loader to transition from the expanded deployed state to the collapsed delivery state within the proximal portion of the lumen of the proximal loader. Moreover, the proximal portion of the lumen further may be sized and shaped to slidably receive a delivery apparatus therethrough, such that the delivery apparatus may engage with the proximal end of the shunt in the collapsed delivery state.
In accordance with yet another aspect of the present invention, an alternative method for delivering a shunt to an atrial septum of a patient is provided. For example, the method may include: advancing a distal end of a sheath having a cap removably disposed thereon from a first atrium, through the atrial septum into a second atrium, the sheath having a shunt disposed therein in a collapsed delivery state, the shunt coupled to a delivery apparatus within the sheath; decoupling the cap from the distal end of the sheath; retracting the sheath relative to the cap and the shunt to partially deploy the shunt within the second atrium; moving the sheath and the shunt together proximally to align a radiopaque marker disposed on the distal end of the sheath with the atrial septum; decoupling the shunt from the delivery apparatus; retracting the sheath until the shunt is fully deployed within the atrial septum; and removing the sheath and delivery apparatus from the patient. The method further may include advancing the sheath distally prior to decoupling the shunt from the delivery apparatus to transition the partially deployed shunt to the collapsed delivery state within the sheath, e.g., for half-way retrieval of the shunt.
In accordance with another aspect of the present invention, a guidewire loading device for loading a guidewire into an atrial shunt delivery cartridge, e.g., a cartridge for loading a shunt for intravascular delivery to the atrial septum of a patient, is provided. The loading device may include a proximal portion having a lumen sized and shaped to receive the atrial shunt delivery cartridge therein and a distal portion having an adjustable lumen. In addition, the loading device may include a pair of flexible wings extending radially from the distal portion. The pair of flexible wings, when a force is applied thereon, may cause a diameter of the adjustable lumen of the distal portion to increase to a size sufficient to receive the atrial shunt delivery cartridge therein. For example, the diameter of the adjustable lumen of the distal portion may be biased toward a size smaller than when the force is applied on the pair of flexible wings. Thus, upon release of the force on the pair of flexible wings, the adjustable lumen of the distal portion will squeeze against the atrial shunt delivery cartridge, thereby holding the cartridge in position to receive the guidewire. Moreover, a free end of the pair of flexible wings may include a flat edge extending parallel to a longitudinal axis of the distal portion.
Embodiments of the present invention are directed to devices for delivering implantable devices to the atrial septum of the heart, and thus may be useful in treating subjects suffering from heart failure or other disorders associated with elevated left atrial pressure. For example, the inventive device may be designed to deliver an hourglass or “diabolo” shaped stent, preferably formed of a shape memory metal as described in U.S. Pat. No. 9,629,715 to Nitzan, assigned to the assignee of the present invention, the entire contents of which are incorporated herein by reference. The delivery device is configured to lodge the stent securely in the atrial septum, preferably the fossa ovalis, to function as an interatrial shunt, allowing blood flow from the left atrium to the right atrium.
Referring to
Referring now to
Release ring 146 is coupled to latching legs 112, 114, and 116. For example, latching legs 112, 114, and 116 may be partially disposed within release ring 146 as illustrated in
Annular member 148 may be partially disposed in the proximal end of cover tube 124 and configured to couple cover tube 124 to catheter 104 via a suitable coupling mechanism, e.g., teeth 150, ribs. Annular member 148 includes lumen 152 sized to accept pull-cord 154 therethrough.
Pull-cord 154 is coupled to release ring 146 and actuation of pull-cord 154 moves release ring 146 from the first position shown in
Pull-cord 154 may be coupled to release ring 146 via release ring base 156. In this embodiment, release ring base 156 is directly coupled to release ring 146 and pull-cord 154 such that actuation of pull-cord 154 moves release ring base 156 to move release ring 146 from the first position the second position, and vice versa.
Spring 158 may be coupled to the proximal surface of release ring base 156 and the distal surface of annular member 148 such that release ring base 156 and annular member 148 maintain spring 158 therebetween. Spring 158 is configured to bias release ring 146 towards a particular position such as towards the first position as shown in
Referring to
Then, the device is collapsed radially to a contracted, delivery state and coupled to the delivery apparatus (step 502). For example, as illustrated in
In
Referring to
Referring back to
The fossa ovalis (particularly its central region) may be punctured with the trans-septal puncture device, and a guidewire may be inserted through the puncture by threading the guidewire through the needle into the left atrium, and then removing the needle (step 504). The puncture through the fossa ovalis then may be expanded by advancing a dilator over the guidewire through the puncture (step 505). Alternatively, a dilator may be advanced over the trans-septal puncture device, without the need for a guidewire. The dilator is used to further dilate the puncture and a sheath then is advanced over the dilator and through the fossa ovalis; the dilator and guidewire or needle then are removed. The sheath, which may be 14 Fr., is then flushed.
Distal end 102 of apparatus 100, with device 400 coupled thereto in a contracted, delivery state, then is advanced into the sheath (step 506). For example, the delivery system may be flushed, e.g., via fluid connected to fluid tube 630, and then loading cartridge 614 may be coupled to sheath 626, e.g., via port 627, as illustrated in
Then, under fluoroscopic and/or echocardiographic visualization, sheath 626 may be repositioned such that the distal tip of sheath 626 is disposed a predetermined distance, e.g., approximately 1-2 cm, distal to the fossa ovalis within the left atrium. Next, device 400 and apparatus 100 are advanced distally such that the device is partially advanced out of the sheath so the first flared end of the device protrudes out of the sheath and into the left atrium, and expands to its deployed state (step 507). For example, device 400 and apparatus 100 may be advanced distally until the handle at proximal end 106 contacts knob 622 as shown in
As another example, the angle θ″ may be substantially less than 90 degrees as shown in
An hourglass shape may aid in non-perpendicular deployment because the flared ends of the device engage the atrial septum, even when positioned at an angle relative to the central axis of the puncture through the atrial septum.
Next, under fluoroscopic and/or echocardiographic visualization, it is verified that the first flared end of the device protrudes from sheath 626 and then knob 622 of Tuohy-Borst connector 620 is used to lock the delivery system in place within the sheath 626. Sheath 626, along with the delivery system 100 are pulled proximally causing the first flared end region of device 400 to engage the left side of the atrial septum AS as shown in
Using fluoroscopic and/or echocardiographic visualization, the clinician next verifies that the device is positioned across the fossa ovalis. The clinician then reduces the pulling force of the sheath and allows the fossa ovalis to straighten. Then, while holding sheath 626 in place, knob 622 is released and the components at distal end 102 of apparatus 100 are moved from an engaged position to a disengaged position, e.g., by actuating handle 108 as shown in
The shunt device then may be fully deployed by pulling the sheath proximally causing the first flared end region to engage the left side of the atrial septum and the neck of the device to lodge in the puncture through the fossa ovalis, and allowing expansion of the second flared end of the device into the right atrium as shown in
Referring to
Like handle 108, handle 708 may be manipulated, for example, by moving finger grips 710 proximally from a locked position shown to an unlocked position. In addition, handle 708 may be manipulated by moving finger grips 710 distally from the locked position to the unlocked position so as to transition components in distal end 702 from the disengaged position to the engaged position to load devices of the present invention. Handle 708 also may include securement mechanism 709 coupled to handle safety lock 711 such that finger grips 710 cannot be moved until handle safety lock 711 is released. Upon activation, handle 708 is retained in position, enabling a single user to perform the procedure.
In one embodiment, hook portions 718, 720, and 722 move generally radially away from center axis 723. The angle between the lower surface of the hook portion and the longitudinal axis of the latching leg is preferably less than 90 degrees and greater than 75 degrees, e.g., 87 degrees, as shown in
Catheter 704 may include cover tube 724 which may have a larger diameter than the remaining shaft of catheter 704. Cover tube 724 comprises a biocompatible material such as a biocompatible metal or polymer, and may be the same or different material than the remaining shaft of catheter 704. Components at distal end 702, such as latching legs 712, 714, and 716, may be at least partially disposed within cover tube 724. Referring back to
Referring now to
Release ring 746 is coupled to latching legs 712, 714, and 716. For example, latching legs 712, 714, and 716 may be partially disposed within release ring 746 as illustrated in
Annular member 748 may be partially disposed in the proximal end of cover tube 724 and configured to couple cover tube 724 to catheter 704 via a suitable coupling mechanism, e.g., teeth 750, ribs. Annular member 748 includes lumen 752 sized to accept control tube 707 therethrough.
Control tube 707 is coupled to release ring 746 and actuation of control tube 707 moves release ring 746 from the first position shown in
Control tube 707 may be coupled to release ring 746 via release ring base 756. In this embodiment, release ring base 756 is directly coupled to release ring 746 and control tube 707 such that actuation of control tube 707 moves release ring base 756 to move release ring 746 from the first position the second position, and vice versa.
Spring 758 may be coupled to the proximal surface of release ring base 756 and the distal surface of annular member 748 such that release ring base 756 and annular member 748 maintain spring 758 therebetween. Spring 758 is configured to bias release ring 746 towards a particular position such as towards the first position as shown in
At step 1106, distal end 702 of apparatus 700, with device 400 coupled thereto, is advanced through the sheath over the guidewire until proximal end 706 of apparatus 700 is a predetermined distance from the proximal end of the sheath such that distal end 702 of apparatus 700 is a predetermined distance from the distal end of the sheath. The guidewire is received from the Luer connector 705 via lumen 755 of control tube 707. Steps 1107-1110 are similar to steps 507-510 described in
In accordance with another aspect of the present invention, knob system 703 may be used for length adjustment of apparatus 700 relative to the sheath during deployment of device 400 at the atrial septum, e.g., to assist in halfway retrieval of device 400. For example, referring now to
Referring now to
Referring to
Referring to
As described above with regard to, e.g., distal end 102 of
For example, to engage hook portions 1307 from the shunt device, release ring 1313 may be moved proximally via pull-chord 1315. As release ring 1313 slides proximally along ramp portion 1311, hook portions 1317 move radially inward toward the central axis of the catheter within window 1309, to thereby disengage with the shunt device without dragging the shunt device inward and insure that the shunt device is released.
Referring to
Exemplary method 1500 of delivering device 400 to reduce left atrial pressure in a subject, for example, a human having a heart pathology, using apparatus 1400 illustrated in
In addition, handle 1408 includes knob 1401. The inner components of knob 1401 includes a threaded portion that corresponds with a threaded portion coupled to sheath 1410. Accordingly, as knob 1401 is rotated about the longitudinal axis of handle 1408, rotational movement of knob 1401 is converted to translational movement of the threaded portion coupled to sheath 1410 along the longitudinal axis of handle 1408, thereby causing movement of sheath 1410 relative to catheter 1404. This permits gradual adjustment of the length of sheath 1410 relative to catheter 1404, and accordingly halfway-retrieval of device 400 when device is halfway deployed as will be described in further detail below. Knob 1401 may not be rotated until third actuator 1424 is moved from a locked position to an unlocked position.
As illustrated in
When third actuator 1424 is moved to the second position, such that third actuator component 1413 is rotated, e.g., counter-clockwise, about the longitudinal axis of handle 1408, the space between the edge of the tooth of third actuator component 1413 and the edge of the indent of actuator ring 1415 increases such that actuator ring 1415 is free to rotate in the same direction, e.g., counter-clockwise until the edge of the indent of actuator ring 1415 engages with the edge of the tooth of third actuator component 1413. In addition, third actuator component 1413 is operatively coupled to a locking mechanism between inner catheter 1411 and a hub disposed within the distal region of sheath 1410 as described in further detail below.
Actuator ring 1415 also may include a grooved pattern along its proximal end for engaging with a corresponding indent along the distal end of second actuator component 1417 coupled to second actuator 1423. Accordingly, the edge of the tooth of third actuator component 1413 may further engage with the indent of actuator ring 1415, to thereby rotate actuator ring 1415 until the groove of actuator ring 1415 engages with the indent of second actuator component 1417. Second actuator 1423 may be moveable between a first and second position. For example,
First actuator component 1419 is moveable along the longitudinal axis of handle 1408, parallel to inner catheter 1411, between a first and second position. For example,
First actuator component 1419 includes a lumen sized and shaped to receive centering element 1429, wherein centering element 1429 is fixed relative to handle 1408. First actuator 1422 is further coupled to proximal portion 1427 sized and shaped to move within a lumen of centering element 1429. Proximal portion 1427 includes a lumen sized and shaped to receive inner catheter 1411, such that proximal portion 1427 is moveable between the first and second positions along inner catheter 1411. First actuator 1422 may be moveably coupled to inner catheter 1411 via proximal portion 1427, and may include port 1439 for coupling to a fluid source to introduce fluid into the guidewire lumen of inner catheter 1411 for flushing. In addition, first actuator component 1419 is coupled to sheath 1410 for extending and retracting the distal end of sheath 1410 as described in further detail below.
In addition, hub 1412 includes one or more engagers, e.g., protrusions 1414, 1416 and 1418, extending radially outward from a central axis of catheter 1404, such that the one or more engagers are disposed circumferentially about the outer surface of hub 1412, e.g., at engagement portion 1428, and are configured to fit securely between struts and rings of the interatrial devices for delivery. Thus, each of the one or more engagers may be sized to engage device 400 in openings between rings 402 and struts 404 when device 400 is in a contracted, delivery state. For example, the distance from the central axis of hub 1412 to the outermost surface of each of the one or more engagers is equal to or slightly less than the inner radius of sheath 1410 so that hub 1412 may be moveable within sheath 1410. The distance from the central axis of hub 1412 to the outermost surface of each of the one or more engagers may be equal to the distance from the central axis of hub 1412 to the outer surface of ring portion 1426. Accordingly, device 400 may be constrained between the one or more engagers and ring portion 1426, and between engagement portion 1428 and sheath 1410 in order to prevent dislodgement or early deployment of device 400 within sheath 1410. As shown in
In addition, inner catheter 1411 is disposed within a central lumen extending through hub 1412 and catheter 1404. Inner catheter 1411 may include a stop, e.g., lock ring 1438, fixed at a distal end of inner catheter 1411, wherein lock ring 1438 is sized and shaped to be disposed within cavity 1430 of hub 1412. Cavity 1430 may extend through at least a portion of engagement portion 1428 of hub 1412, or completely through engagement portion 1428 of hub 1412 and at least a portion of ring portion 1426 of hub 1412. Lock ring 1438 ensures that hub 1412 does not extend beyond a predetermined distance distally along inner catheter 1411, and that inner catheter 1411 does not retract beyond the predetermined distance proximally relative to hub 1412. Inner catheter 1411 also may include guidewire lumen 1425 sized and shaped to receive a guidewire therethrough. For example, delivery apparatus 1400 may be advanced over a guidewire such that the distal end of sheath 1410 having distal end 1402 coupled to device 400 disposed therein, is positioned across the fossa ovalis.
Referring now to
Referring now to
Referring back to
If for any reason device 400 is not in the proper position for deployment within the atrial septum, sheath 1410 may be advanced over device 400 while catheter 1404 is stationary, thereby collapsing first flared end region 401 within sheath 1410. Specifically, knob 1401 of handle 1408 may be rotated to cause sheath 1410 to move translationally relative to catheter 1404 and device 400, to thereby collapse device 400 within sheath 1410. For example, sheath 1410 may be moved over collapsed device 400 until device 400 is completely collapsed within sheath 1410. Distal end 1402, with device 400 disposed therein, may then be retrieved. Alternatively, distal end 1402 may be repositioned relative to the fossa ovalis of the atrial septum prior to partially advancing first flared end region 401 out of sheath 1410 within the left atrium.
When third actuator 1424 is in the second position and hub 1412 and catheter 1404 are decoupled, the delivery apparatus may be pulled proximally by the physician such that the atrial septum maintains device 400 in position against the left side of the atrial septum until second flared end region 403 of device 400 is no longer constrained between hub 1412 and sheath 1410 as shown in
Referring back to
Any remaining components of the delivery system then may be removed, e.g., sheath, distal end of delivery apparatus, the catheter, and the guidewire (step 1510). Once positioned in the fossa ovalis as shown in
It should be noted that the inventive devices also may be used with patients having disorders other than heart failure. For example, in one embodiment the device may be implanted in a subject suffering from myocardial infarction, for example in the period immediately following myocardial infarction (e.g., within a few days of the event, or within two weeks of the event, or even within six months of the event). During such a period, the heart remodels to compensate for reduced myocardial function. For some subjects suffering from severe myocardial infarction, such remodeling may cause the function of the left ventricle to significantly deteriorate, which may lead to development of heart failure Implanting an inventive device during the period immediately following myocardial infarction may inhibit such deterioration in the left ventricle by reducing LAP and LVEDP during the remodeling period. The device optionally then may be removed as described in further detail below.
Exemplary method 1700 of retrieving device 400 from a subject, for example, from a puncture through the fossa ovalis, will now be described with reference to
At step 1702, a guidewire is inserted through the neck of the implanted shunt device through the fossa ovalis of the atrial septum into the left atrium. The guidewire may be inserted using techniques readily known in the art. At step 1703, the sheath is inserted over the guidewire and positioned in proximity to the flared end region of the shunt device disposed in right atrium. The guidewire may then be removed. At step 1704, the retrieval catheter and the restraint member are delivered through the sheath in proximity to the flared end region of the shunt device disposed in right atrium.
At step 1705, retrieval catheter 1804 along with restraint member 1808 are advanced distally and exposed beyond the distal end of sheath 1802 within the right atrium such that hook portions 1806 are within at least a portion of second flared end region 403 of device 400, as illustrated in
At step 1708, while hook portions 1806 are maintained in placed and engaged with second flared end region 403 of device 400, restraint member 1808 is advanced distally toward hook portions 1806 via control tube 1810, thereby causing hook portions 1806, and accordingly second flared end region 403, to transition to a compressed configuration, as illustrated in
In accordance with another aspect of the present invention, exemplary method 1900 of retrieving device 400 from a subject, for example, from a puncture through the fossa ovalis, will now be described with reference to
At step 1902, a guidewire is inserted through the neck of the implanted shunt device through the fossa ovalis of the atrial septum into the left atrium. The guidewire may be inserted using techniques readily known in the art. At step 1903, the sheath is inserted over the guidewire and positioned in proximity to the flared end region of the shunt device disposed in right atrium. At step 1904, the grappling hook and the inflatable balloon catheter are delivered through the sheath over the guidewire in proximity to the flared end region of the shunt device disposed in right atrium.
At step 1905, inflatable balloon catheter 2008 is advanced distally, e.g., over the guidewire (not shown), and exposed beyond the distal end of sheath 2002 within the right atrium in a deflated condition such that inflatable balloon catheter 2008 is positioned within at least a portion of second flared end region 403 of device 400, as illustrated in
At step 1907, grappling hook 2004 is advanced distally and exposed beyond the distal end of sheath 2002 within the right atrium. As illustrated in
At step 1909, while hook portions 2006 are maintained in placed and engaged with second flared end region 403 of device 400, inflatable balloon catheter 2008 is deflated and advanced distally into the left atrium. Alternatively, inflatable balloon catheter 2008 may be deflated and removed from the patient's body or deflated and retracted into a balloon channel within sheath 2002. Deflation of inflatable balloon catheter 2008 causes hook portions 2006 of grappling hook 2004, and accordingly second flared end region 403, to transition to a compressed configuration, as illustrated in
Next, at step 1910, sheath 2002 is advanced distally over grappling hook 2004, device 400, and inflatable balloon catheter 2008, through the atrial septum AS and into the left atrium, thereby causing first flared end region 401 of device 400 to transition to a compressed configuration within sheath 2002, as illustrated in
Referring to
Referring now to
Exemplary method 2300 of using loading tool 2200 to load device 400 into apparatus 2100 will now be described with reference to
In accordance with the principles of the present invention, the latching legs and hook portions of engagement apparatus 2120 may be actuated to be in a disengaged position, e.g., contracted inward, before proximal loader 2202 is completely advanced within distal loader 2204 so that the engagement hooks of engagement apparatus 2120 may be appropriately aligned with the struts of second flared end region 403 of device 400, and so that second flared end region 403 can smoothly enter lumen 2208 of proximal loader 2202. Once aligned, the latching legs and hook portions of engagement apparatus 2120 may be actuated to be in a engaged position to engage with second flared end region 403 of device 400 within lumen 2208 of proximal loader 2202 (step 2305).
Exemplary method 2700 of delivering device 400 to reduce left atrial pressure in a subject, for example, a human having a heart pathology, using apparatus 2100 illustrated in
At step 2701, an interatrial shunt, e.g., device 400, and apparatus 2100 of
Pigtail-shaped portion 2112 of distal tip 2110 of delivery apparatus 2100 with device 400 collapsed therein and coupled to engagement apparatus 2120 of apparatus 2100 is then advanced over guidewire 2801 through the puncture in the fossa ovalis and into left atrium LA (step 2705) as illustrated in
Then, under fluoroscopic and/or echocardiographic visualization, apparatus 2100 may be repositioned such that radiopaque marker 2801 is aligned with the fossa ovalis (step 2707) as illustrated in
If for any reason device 400 is not in the proper position for deployment within the atrial septum, catheter 2104 may be advanced over device 400 while distal tip 2110 is stationary, thereby collapsing the first flared end region within catheter 2104 (step 2708) as illustrated in
After step 2707 described above, when device 400 is properly positioned relative to the atrial septum, engagement apparatus 2120 may be disengaged from device 400, e.g., hook portions 2118 may be moved from an engaged positioned radially inward to a disengaged position. Then, catheter 2104 may be retracted proximally relative to distal tip 2110, causing the second flared end region of device 400 to be exposed within right atrium RA beyond the distal end of catheter 2104 such that the second flared end region transitions from the collapsed delivery state to an expanded state within right atrium RA (step 2710) as illustrated in
As illustrated in
Referring now to
In addition, guidewire loading tool 2900 has central lumen 2905 extending through proximal portion 2903 and distal portion 2901, sized and shaped to receive loading cartridge 614 therein, e.g., when device 400 is collapsed in a delivery state within loading cartridge 614 as described above with reference to
Referring now to
Next, as illustrated in
Exemplary method 3100 of delivering device 400 to reduce left atrial pressure in a subject, for example, a human having a heart pathology will now be described with reference to
At step 3105, the distal end of sheath 3202 having cap 3204 disposed thereon is advanced over guidewire 3201 to a position within right atrium RA adjacent atrial septum AS, as shown in
At step 3106, balloon 3206 may be inflated via the external fluid source and the inflation lumen until balloon 3206 reaches a desired inflated size, as shown in
At step 3108, cap 3204 may be decoupled from the distal end of sheath 3202, and retracted through the lumen of sheath 3202 and removed over guidewire 3201, as shown in
Solely for exemplary purposes,
At step 3111, delivery apparatus 1301 may be disengaged from the second flared end region of device 400 while the second flared end region is in a collapsed delivery state within sheath 3202 as discussed above. For example, the release ring of delivery apparatus 1301 may be retracted, thereby causing the hook portions to move radially inward to disengage with device 400 within sheath 3202. Once disengaged, delivery apparatus 1301 may be retracted and/or completely removed from sheath 3202, as shown in
At step 3113, balloon 3206 is deflated via the inflation lumen, as shown in
While various illustrative embodiments of the invention are described above, it will be apparent to one skilled in the art that various changes and modifications may be made herein without departing from the invention. It will further be appreciated that the devices described herein may be implanted in other positions in the heart. For example, device 400 may be implanted in an orientation so as to shunt blood from the right atrium to the left atrium, thus decreasing right atrial pressure; such a feature may be useful for treating a high right atrial pressure that occurs in pulmonary hypertension. Similarly, device 400 may be implanted across the ventricular septum, in an orientation suitable to shunt blood from the left ventricle to the right ventricle, or in an orientation suitable to shunt blood from the right ventricle to the left ventricle. The appended claims are intended to cover all such changes and modifications that fall within the true spirit and scope of the invention.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2020/053118 | 4/2/2020 | WO |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2020/202046 | 10/8/2020 | WO | A |
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| 108451569 | Aug 2018 | CN |
| 1987777 | Nov 2008 | EP |
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| 1965842 | Nov 2011 | EP |
| 3400907 | Nov 2018 | EP |
| 2827153 | Jan 2003 | FR |
| WO-9531945 | Nov 1995 | WO |
| WO-9702850 | Jan 1997 | WO |
| WO-9727898 | Aug 1997 | WO |
| WO-9960941 | Dec 1999 | WO |
| WO-0044311 | Aug 2000 | WO |
| WO-0050100 | Aug 2000 | WO |
| WO-0110314 | Feb 2001 | WO |
| WO-0126585 | Apr 2001 | WO |
| WO-0191828 | Dec 2001 | WO |
| WO-0226281 | Apr 2002 | WO |
| WO-02071974 | Sep 2002 | WO |
| WO-02087473 | Nov 2002 | WO |
| WO-03053495 | Jul 2003 | WO |
| WO-2005027752 | Mar 2005 | WO |
| WO-2005074367 | Aug 2005 | WO |
| WO-2006127765 | Nov 2006 | WO |
| WO-2007083288 | Jul 2007 | WO |
| WO-2008055301 | May 2008 | WO |
| WO-2008070797 | Jun 2008 | WO |
| WO-2009029261 | Mar 2009 | WO |
| WO-2010128501 | Nov 2010 | WO |
| WO-2010129089 | Nov 2010 | WO |
| WO-2010139771 | Dec 2010 | WO |
| WO-2010139771 | Jan 2011 | WO |
| WO-2011062858 | May 2011 | WO |
| WO-2013096965 | Jun 2013 | WO |
| WO-2013172474 | Nov 2013 | WO |
| WO-2016178171 | Nov 2016 | WO |
| WO-2017118920 | Jul 2017 | WO |
| WO-2018158747 | Sep 2018 | WO |
| WO-2019015617 | Jan 2019 | WO |
| WO-2019085841 | May 2019 | WO |
| WO-2019109013 | Jun 2019 | WO |
| WO-2019142152 | Jul 2019 | WO |
| WO-2019179447 | Sep 2019 | WO |
| WO-2019212812 | Nov 2019 | WO |
| WO-2019218072 | Nov 2019 | WO |
| WO-2020206062 | Oct 2020 | WO |
| WO-2020257530 | Dec 2020 | WO |
| WO-2021050589 | Mar 2021 | WO |
| WO-2021113670 | Jun 2021 | WO |
| WO-2021212011 | Oct 2021 | WO |
| WO-2021224736 | Nov 2021 | WO |
| WO-2022046921 | Mar 2022 | WO |
| WO-2022076601 | Apr 2022 | WO |
| WO-2022091018 | May 2022 | WO |
| WO-2022091019 | May 2022 | WO |
| WO-2022103973 | May 2022 | WO |
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| Number | Date | Country | |
|---|---|---|---|
| 20220184356 A1 | Jun 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16374698 | Apr 2019 | US |
| Child | 17600079 | US |
