Patent Grant
11744573
The present teachings generally relate to a delivery catheter system that is adapted to deliver multiple devices, such as guide wires, across the commissure of the mitral valve annulus. The present teachings further relate to implanting a first tissue anchor across the commissure of the mitral annulus. Other embodiments of the present teachings relate to pulling a ventricular free wall towards a septum.
The left side of a human heart includes the left atrium (LA) and the left ventricle. The aorta receives oxygenated blood from the left ventricle through the aortic valve, which serves to prevent regurgitation of blood back into the left ventricle. The mitral valve is positioned between the left atrium and the left ventricle and allows a one-way flow of the oxygenated blood from the left atrium to the left ventricle.
The mitral valve, which will be described below in greater detail, includes an anterior leaflet and a posterior leaflet that are coupled to the chordae tendineae. The commissures define an area where the anterior and posterior leaflets join and extend into the annulus. The chordae tendineae serve as “tension members” that prevent the leaflets of the mitral valve from moving past their dosing point and prolapsing back into the left atrium. When the left ventricle contracts during a systole, the chordae tendineae prevent the upward motion (toward the left atrium) of the anterior and posterior leaflets from passing the point where the anterior and posterior leaflets meet and seal to prevent backflow from the left ventricle to the left atrium (“mitral regurgitation” or “mitral insufficiency”). The chordae tendineae arise from the columnae carneae or, more specifically, the musculi papillares (papillary muscles) of the columnae carneae. In various figures herein, some anatomical features have been deleted solely for clarity.
The anterior leaflet and the posterior leaflet of the mitral valve are generally thin, flexible membranes. When the mitral valve is closed, the anterior leaflet and the posterior leaflet are generally aligned and contact each other along a “line of coaptation” several millimeters from their free edges to create a seal that prevents mitral regurgitation. Alternatively, when the mitral valve is opened, blood flows downwardly into the left ventricle through an opening created between the anterior leaflet and the posterior leaflet.
Many problems relating to the mitral valve may cause many types of ailments. Such problems include, but are not limited to, mitral regurgitations. A mitral regurgitation, or leakage, is the backflow of blood from the left ventricle into the left atrium due to an imperfect closure of the mitral valve. Leakage often occurs when the anterior and posterior leaflets do not seal against each other, resulting in a mitral orifice between the anterior leaflet and the posterior leaflet when the leaflets are supposed to be fully coapted during a systole.
In general, a relatively significant systolic mitral orifice may exist between the anterior leaflet and the posterior leaflet for a variety of reasons. For example, a mitral orifice may exist due to congenital malformations because of ischemic disease or the heart having been damaged by a previous heart attack. Such a mitral orifice may also be treated in a congestive heart failure, e.g., cardiomyopathy or some other type of distress which causes a heart to be enlarged. Enlargement of the heart can result in dilation (stretching) of the mitral annulus. This enlargement is usually limited to the posterior valve annulus and is associated with the posterior leaflet because the anterior annulus is a relatively rigid fibrous structure. When the posterior annulus enlarges, it causes the posterior leaflet to move away from the anterior leaflet, causing a mitral orifice during systoles because the two leaflets no longer form a proper coaptation. This results in leakage of blood through the valve or regurgitation.
The blood leakage through the mitral valve generally causes a heart to operate less efficiently because the heart pumps blood both out to the body via the aorta and back (in the form of mitral regurgitation) into the left atrium. Leakage through the mitral valve, or general mitral insufficiency, is thus often considered to be a precursor to congestive heart failures (CHF) or a cause to progressively worsening of a heart failure. There are generally different levels of symptoms associated with a heart failure. These levels are classified by the New York Heart Association (NYHA) functional classification system. The levels range from a Class 1 level which is associated with an asymptomatic patient who has substantially no physical limitations to a Class 4 level which is associated with a patient who is unable to carry out any physical activity without discomfort and has symptoms of cardiac insufficiency even at rest. In general, correcting or reducing the degree of mitral valve leakage can reduce a patient's NYHA grade. For instance, a patient with a Class 4 classification may have his classification reduced to Class 3 or Class 2 and, as a result, the patient becomes relatively comfortable at rest or even during a mild physical exertion. By eliminating the backflow of blood into the left atrium, therapies that reduce mitral insufficiency reduce the workload of the heart and may prevent or slow the degradation of heart function and congestive heart failure symptoms that are common when a significant degree of mitral insufficiency remains uncorrected.
Treatments used to correct for mitral valve leakage or, more generally, CHF, are typically highly invasive, open-heart surgical procedures. In extreme cases, this may include implantation of a ventricular assist device such as an artificial heart in a patient with a failing heart. The implantation of a ventricular assist device is often expensive, and a patient with a ventricular assist device must be placed on an extended anti-coagulant therapy. An anti-coagulant therapy reduces the risk of blood clot formation, for example, within the ventricular assist device. Reducing the risks of blood clots associated with the ventricular assist device is desirable, but anti-coagulant therapies may increase the risk of uncontrollable bleeding in a patient, e.g., as a result of a fall.
Rather than implanting a ventricular assist device, bi-ventricular pacing devices similar to pacemakers may be implanted in some cases, including those where a heart beats inefficiently in a particular asynchronous manner. While the implantation of a bi-ventricular pacing device may be effective, not all heart patients are suitable for receiving a bi-ventricular pacing device. Further, the implantation of a bi-ventricular pacing device is expensive, and is generally not effective in significantly reducing or eliminating the degree of mitral regurgitation.
Open-heart surgical procedures that are intended to correct a mitral valve leakage, specifically, can involve the implantation of a replacement valve. Valves from animals, e.g., pigs, may be used to replace a mitral valve in a human. While a pig valve may relatively successfully replace a mitral valve, such replacement valves generally wear out, thereby requiring additional open surgeries at later dates. Mechanical valves, which are less likely to wear out may also be used to replace a leaking mitral valve. However, when a mechanical valve is implanted, there is an increased risk of thromboembolism and, as a result, the patient is generally required to undergo extended anti-coagulant therapies.
A less invasive surgical procedure involves a heart bypass surgery through a port access procedure. For a port access procedure, the heart may be accessed by cutting between ribs or sometimes removing parts of one or more ribs, as opposed to dividing the sternum and opening the entire chest of a patient in an open-heart surgery.
One open-heart surgical procedure that is particularly successful in correcting a mitral valve leakage and mitral regurgitation is an annuloplasty procedure. During an annuloplasty procedure, a medical device such as an annuloplasty ring may be implanted surgically on the left atrial side of the mitral annulus (i.e., the base of the mitral valve to the heart). The device reduces a dilated mitral valve annulus to a relatively normal size, moves the posterior leaflet closer to the anterior leaflet to aid anterior-posterior leaflet coaptation, and improves the quality of mitral valve closures during systoles. Annuloplasty rings are often shaped substantially like the letter “D” to correspond to the natural shape of the mitral annulus as viewed from above. Typically, the rings are formed from a rod or tube of a biocompatible material, including a plastic that has a DACRON mesh covering.
In order for an annuloplasty ring to be implanted a surgeon surgically attaches the annuloplasty ring to the mitral valve on its atrial side. Conventional methods for installing a ring require an open-heart surgery which involves opening a patient's sternum and placing the patient on a heart-bypass machine. The annuloplasty ring is sewn on the top portion of the mitral valve. In sewing the annuloplasty ring onto the mitral valve, a surgeon generally sews the straight side of the “D” to the fibrous tissue located at the junction between the posterior wall of the aorta and the base of the anterior mitral valve leaflet. As the curved part of the ring is sewn to the posterior aspect of the annulus, the surgeon alternately acquires a relatively larger amount of tissue from the mitral annulus, e.g., a one-eighth inch bite of tissue, using a needle and thread, compared to a relatively smaller bite taken of the fabric covering of the annuloplasty ring. After the thread has loosely coupled the annuloplasty ring to the mitral valve annulus tissue, the annuloplasty ring is slid into contact with the mitral annulus. The tissue of the posterior mitral annulus that was previously stretched out, e.g., due to an enlarged heart, is effectively reduced in circumference and pulled forwards towards the anterior mitral leaflet by the tension applied by annuloplasty ring with the suture or thread. As a result, a mitral orifice between the anterior leaflet and the posterior leaflet may be reduced and even substantially closed off during a ventricular contraction or systole in many cases, thereby significantly reducing or even eliminating mitral insufficiency. After the mitral valve is shaped by the ring, the anterior and posterior leaflets will reform typically by pulling the posterior leaflet forward to properly meet the anterior leaflet and create a new contact line that will enable the mitral valve to function properly.
Although a patient that receives an annuloplasty ring may be subjected to anti-coagulant therapies, the patient is only subjected to the therapies for a matter of weeks, e.g., until tissue grows over the annuloplasty ring.
Another type of procedure that is generally effective in reducing mitral valve leakage associated with purpose of the valve leaflets involves placing a single edge-to-edge suture in the mitral valve. For example, in an Alfieri stitch or a bow-tie repair procedure, an edge-to-edge stitch is made approximately at the center of the mitral orifice between an anterior leaflet and a posterior leaflet of a mitral valve. Once the stitch is in place between the anterior and posterior leaflets, it is pulled in to form a suture which holds the anterior leaflet against the posterior leaflet.
Another surgical procedure that reduces mitral valve leakage involves placing sutures along a mitral valve annulus around the posterior leaflet these sutures may be formed as a double track, e.g., in two “rows” from a single strand of suture material. The sutures are tied off approximately at a central point of the posterior leaflet. Pledgets are often positioned under selected sutures to prevent the sutures from tearing through the annulus. When the sutures are tightened and tied on the circumference of the annulus may effectively be reduced to a desired size such that the size of a systolic mitral orifice between the posterior leaflet and the anterior leaflet may be reduced.
While the invasive surgical procedures have proven to be effective in the treatment of mitral valve leakage, they often have significant drawbacks. Any time a patient undergoes an open heart surgery, there are risks of infection. Opening the sternum and using a cardiopulmonary bypass machine has also been shown to result in a significant incidence of both short and long term neurological deficits. Further, given the complexity of an open-heart surgery and the significant recovery time, people that are not greatly inconvenienced by CHF symptoms, e.g., people at a Class 1 classification, may choose not to have any corrective surgery. In addition, people that need an open heart surgery the most, e.g., people at a Class 4 classification, may either be too frail or too weak to undergo the surgery. Hence, many people that may benefit from a surgically repaired mitral valve may not undergo surgeries.
Alternatively, in a minimally invasive method, by using a catheter system, a cinching device with distal, mid, and proximal anchors is placed within the lumen of the CS to allow plication of the annulus via the CS. In practice, these anchors are cinched together and the distance between them is shortened by pulling a flexible tensile member such as a cable or suture. As a result, the valve annulus is shortened and the posterior leaflet is pulled closer to the anterior leaflet in a manner similar to an annuloplasty procedure. Unfortunately, since the tissue that forms the CS is relatively delicate, the anchors are prone to tear the tissue during the cinching procedure. In addition, the effect on the mitral annulus may be reduced when the CS of a particular patient is not directly aligned with the mitral annulus. Other minimally invasive techniques have been proposed but have various drawbacks related to such factors as effectiveness and/or accuracy of a catheter-based implementation.
Catheter-based surgical procedures have been used to repair a defective mitral valve. Specifically, anchors are secured at a plurality of locations around the annulus near the posterior leaflet of a mitral valve. Each anchor has a suture coupled thereto. The sutures are collectively gathered and pulled tight. As the sutures are pulled, the tissue between each pair of the adjacent anchors is plicated, thereby shortening the length of the annulus and drawing the posterior leaflet toward the anterior leaflet. Similar techniques can also be used to repair a defective tricuspid valve.
During a surgical procedure, anchors are usually introduced and seemed sequentially. A typical repair by using the catheter based surgical procedure includes one or more steps selected from introducing a catheter to a proximity of the annulus, making an incision at the annulus, introducing a guide wire through the incision site, withdrawing the catheter, introducing an anchor by tracking a second catheter through the guide wire, securing the anchor in the annulus, and withdrawing the second catheter. This procedure is repeated to secure a second anchor.
Catheters capable of delivering multiple guide wires or anchors have been disclosed. Without claiming to have exhaustively examined prior art references and without attempting to characterize any prior art reference, U.S. Patent Application Publication No. 2008-0228265 discloses a triple lumen catheter. However, distances between two of the three lumens are usually fixed. In addition, during a deployment, the two outer catheters are generally advanced lengthwise as well as laterally. In certain instances, one or both of the two outer catheters are caught by the chordae tendineae during a deployment.
There generally exists a need for an improved catheter to simplify the catheter-based mitral valve correction.
One aspect of the present teachings provides a device for percutaneously locating the mitral valve commissure. In various embodiments, the device comprises a bow catheter, a central catheter, and two bow wires. In various embodiments, the bow catheter has a proximal end, a distal end, and an elongated tubular body. In various embodiments, the central catheter also has a proximal end, a distal end, and an elongated tubular body, wherein the central catheter slidably is disposed within a lumen of the bow catheter. And in some embodiments, two bow wires each has a proximal end attaching to the distal end of the bow catheter and a distal end attaching to the distal end of the central catheter. In some embodiments, as the distal ends of the bow catheter and central catheter come closer to each other, the two bow wires bend radially outward, forming a general plane.
Another aspect of the present teachings provides a device for percutaneously implanting a wire across the mitral annulus at the mitral valve commissure. In various embodiments, this device comprises a bow catheter, a central catheter, two bow wires, and at least one wire delivery catheter. In some embodiments, the bow catheter has a proximal end, a distal end, and an elongated tubular body. In some embodiments, the central catheter also has a proximal end, a distal end, and an elongated tubular body, wherein the central catheter slidably is disposed within a lumen of the bow catheter. In some embodiments, the two bow wires each has a proximal end attaching to the distal end of the bow catheter and a distal end attaching to the distal end of the central catheter. In some embodiments, as the distal ends of the bow catheter and central catheter come closer to each other, the two bow wires bend radially outward forming a general plane. In some embodiments, the at least one wire delivery catheter has a distal portion attaching to a portion of one of the two bow wire. In some embodiments, as the two bow wires bend radially outward, the distal portion of the wire delivery catheter is directed to pivot outward radially from an elongated axis of the wire delivery catheter.
Another aspect of the present teachings provides a method for percutaneously locating a mitral valve commissure. In various embodiments, the method comprises providing a mitral valve commissure locating system. In some embodiments, the mitral valve commissure locating system comprises a bow catheter having a proximal end, a distal end, and an elongated tubular body; a central catheter having a proximal end, a distal end, and an elongated tubular body; and two bow wires with proximal ends and distal ends. In some embodiments, the central catheter slidably is disposed within a lumen of the bow catheter. In some embodiments, the proximal ends of the bow wire attach to the distal end of the bow catheter and the distal ends of the bow wire attach to the distal end of the central catheter. And in some embodiments, as the distal ends of the bow catheter and central catheter come closer to each other, the two bow wires bend radially outward to form a general plane. In various embodiments, the method also comprises delivering the mitral valve commissure locating system percutaneously across the mitral valve with the distal ends of the bow wires distal to the mitral annulus and the proximal ends of the bow wires proximal to the mitral annulus. In various embodiments, the method comprises rendering the distal end of the bow catheter and the distal end of the central catheter closer to each other and the two bow wires bending radically outward. In some embodiments, the method also comprises visualizing the curvature of the bow wires as it keeps bending radially outward and discontinuing outward bending of the bow wires when a narrower waist forms along the curvature of the bow wires.
Another aspect of the present teachings provides a method for percutaneously implanting a wire across the mitral annulus at the mitral valve commissure. In various embodiments, the method comprises providing a mitral valve commissure locating system and at least one wire delivery catheter attaching to the mitral valve commissure locating system. In various embodiments, the mitral valve commissure locating system comprises a bow catheter comprising a proximal end, a distal end, and an elongated tubular body; a central catheter comprising a proximal end, a distal end, and an elongated tubular body; and two bow wires each comprising a proximal end and a distal end. In some embodiments, the central catheter slidably is disposed within a lumen of the bow catheter. In some embodiments, the proximal ends of the bow wire attach to the distal end of the bow catheter and the distal ends of the bow wire attach to the distal end of the central catheter. And as the distal ends of the bow catheter and central catheter come closer to each other, the two bow wires bend radially outward and form a general plane. In certain embodiments, the at least one wire delivery catheter comprises a distal portion attaching to a portion of one of the two bow wire. In certain embodiments, as the two bow wires bend radially outward, the distal portion of the wire delivery catheter is directed to pivot outward radially from an elongated axis of the wire delivery catheter. In various embodiments, the method comprises delivering the mitral valve commissure locating system percutaneously across the mitral valve, with the distal ends of the bow wires distal to the mitral annulus and the proximal ends of the bow wires proximal to the mitral annulus. In some embodiments, the method comprises rendering the distal end of the bow catheter and the distal end of the central catheter closer to each other and the two bow wires bending radially outward. In some embodiments, the method comprises visualizing the curvature of the bow wires as they keep bending radially outward, and discontinuing outward bending of the bow wires when a narrower waist forms along the curvature of the bow wires. In some embodiments, the method comprises positioning a distal end of the wire delivery catheter proximally and adjacent to the mitral annulus, and advancing a wire distally through the lumen of the wire delivery catheter across the mitral annulus.
Certain specific details are set forth in the following description and Figures to provide an understanding of various embodiments of the present teachings. Those of ordinary skill in the relevant art will understand that they can practice other embodiments of the present teachings without one or more of the details described herein. Thus, it is not the intention of the Applicants to restrict or in any way limit the scope of the appended claims to such details. While various processes are described with reference to steps and sequences in the following disclosure, the steps and sequences of steps should not be taken as required to practice all embodiments of the present teachings. Thus, it is not the intention of the Applicants to restrict or in any way limit the scope of the appended claims to such steps or sequences of steps.
As used herein, the terms “subject” and “patient” refer to an animal, such as a mammal, including livestock, pets, and preferably a human. Specific examples of “subjects” and “patients” include, but are not limited to, individuals requiring medical assistance and, in particular, requiring treatment for symptoms of a heart failure.
As used herein, the term “lumen” means a canal, duct, generally tubular space or cavity in the body of a subject including veins, arteries, blood vessels, capillaries, intestines, and the like. The term “lumen” can also refer to a tubular space in a catheter, a sheath, or the like in a device.
As used herein, the term “proximal” means close to the operator (less into the body) and “distal” shall mean away from the operator (further into the body). In positioning a medical device from a downstream access point, distal is more upstream and proximal is more downstream.
As used herein, the term “catheter” or “sheath” encompasses any hollow instrument capable of penetrating a body tissue or interstitial cavities and providing a conduit for selectively injecting a solution or gas. The term “catheter” or “sheath” is also intended to encompass any elongate body capable of serving as a conduit for one or more of the ablation, expandable or sensing elements. Specifically, in the context of coaxial instruments, the term “catheter” or “sheath” can encompass either the outer catheter body or sheath or other instruments that can be introduced through such a sheath. The use of the term “catheter” should not be construed as meaning only a single instrument but rather is used to encompass both singular and plural instruments, including coaxial, nested, and other tandem arrangements. Moreover, the terms “sheath” or “catheter” are sometime used interchangeably to describe catheters having at least one lumen through which instruments or treatment modalities can pass.
Unless otherwise specified, all numbers expressing quantities, measurements, and other properties or parameters used in the specification and claims are to be understood as being modified in all instances by the term “about”. Accordingly, unless otherwise indicated, it should be understood that the numerical parameters set forth in the following specification and attached claims are approximations. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, numerical parameters should be read in light of the number of reported significant digits and the application of ordinary rounding techniques.
An aspect of the present teachings provides a positioning catheter system deploys across the mitral orifice between the anterior and posterior leaflets, making out two mitral valve commissures. In various embodiments, the positioning catheter system includes a central catheter, a guide wire, and a bow catheter with two bow wires. In various embodiments upon deployment, at least one of the two bow wires bends radially outward, along the slit opening of the mitral orifice until it reaches the commissure.
Another aspect of the present teachings provides a delivery catheter system for delivering multiple wires across the mitral annulus at the mitral valve commissure. In various embodiments, the delivery catheter system comprises a positioning catheter system. In some embodiments, a wire delivery catheter tracks along the positioning catheter system and deploys a wire across the mitral annulus at the mitral valve commissure, in other embodiments, the delivery catheter system includes two wire delivery catheters each tracking along the bow wire and reaching the mitral valve commissure. In some embodiments, each wire delivery catheter independently deploys one wire across the mitral annulus at the mitral valve commissure.
Another aspect of the present teachings provides a method of plicating mitral annulus tissue around the mitral valve commissure. Upon deploying wire across the mitral annulus at the mitral valve commissure, another aspect of the present teachings further discloses implanting two tissue anchors across the annulus at the mitral valve commissure with a pre-defined distance in between. The present teachings further disclose reducing the distance between the two tissue anchors, thereby plicating the annulus tissues.
The following description refers to
The normal anterior and posterior leaflets (8, 10) close (coapt) from their lateral to medial portions (coaptation line) during a systole, preventing blood from back flowing into the left atrium (2). The opening between the anterior and posterior leaflets (8, 10) is surrounded by a fibrous ring known as the mitral annulus (16), which resides in the left atrio-ventricular groove. The mitral annulus (16) consists of an anterior part (16a) and a posterior part (16b).
There are two papillary muscles (18, 20) arising from the area between the apical and middle thirds of the left ventricular wall, the anterolateral papillary muscles (18) and the posteromedial papillary muscle (20). Several dozens of tendinous chords (22) originate from these papillary muscles (18, 20) and attach to the ipsilateral half of the anterior and posterior mitral leaflets (8, 10).
The guide wire (80) is slidably disposed within the axial lumen (66) of the central catheter (60). A clinician can extend the guide wire (80) distally so that the distal end (82) of the guide wire (80) is outside of the distal end (62) of the central catheter (60). A clinician can also retract the guide wire (80) proximally so that the distal end (82) of the guide wire (80) is within the axial lumen (66) of the central catheter (60).
The central catheter (60) is slidably disposed within the axial lumen (76) of the bow catheter (70). The bow wires (30, 40) also have proximal ends (34, 44), distal ends (32, 42), and elongated bow wires (36, 46) between the two ends. As illustrated in
According to one embodiment of the present teachings, the mitral commissure locating system (50) comprises an elongated delivery profile and an expanded deployed profile.
In some embodiments of the present teachings, the bow wires (30, 40) are made of a material conventionally used fix guide wire (80). Examples of the material include a straight stainless steel wire, a coiled stainless steel wire, a glass fiber, a plastics material, nitinol, and etc. In one embodiment, the bow wires (30, 40) are made of an adaptable material that is configured to curve radically outward as its distal (32, 42) and proximal ends (34, 44) come together. In another embodiment, the bow wires (30, 40) are made of an adaptable material that at least a portion of the bow wires (30, 40) arc radially as the bow wires (30, 40) encounters tissues of a heart, for example, as described later in the present teachings.
According to one embodiment of the present teachings, the mitral commissure locating system (50) transitions from its delivery profile to its deployed profile by a clinician from outside of the body. That is, a clinician retracts the proximal end of the central catheter (60) proximally while holding the bow catheter (70) steady, reduces the distance between the distal ends of the central catheter (60) and bow catheter, and expands the bow wire radially. Alternatively, a clinician can push the proximal end of the bow catheter (70) distally while holding the central catheter (60) steady, thereby deploying the mitral commissure locating system (50). One skilled in the art should understand that mechanisms, steps, and details of the deployment can vary. What has been disclosed in the present teachings is only exemplary and should not be viewed as limiting.
Now referring to
According to one embodiment of the present teachings, a delivery sheath (48) is directed into the aorta (24), through the aortic valve and into the left ventricle (4) between the tendinous chords (22). This delivery sheath (48) is then used as a conduit for the subsequent device delivery to the treatment site. Thus, the mitral commissure locating system (50) can be advanced through the delivery sheath (48) to the treatment location. One skilled in the art should understand, a delivery sheath (48) may not be necessary and the mitral commissure locating system (50) can be directly advanced to the treatment location.
In one embodiment of the present teachings, the guide wire (80) is first inserted through the delivery sheath (48) and enters the left ventricle (4). A clinician can manipulate the guide wire (80) so that the distal end (82) of the guide wire (80) is steered to enter between the papillary muscles (18, 20), through the slit between the posterior (10) and anterior mitral leaflets (8), and into the left ventricle (4). In some embodiments, the distal end (82) of the guide wire (80) can be turned, rotated, or deflected. The delectability or steerability of the guide wire (80) allows a clinician to manipulate the distal end (82) of the guide wire (80) from outside of the body and advance to the mitral annular slit between the posterior (10) and anterior mitral leaflets (8), and further distally to the left pulmonary vein when needed. Design and construction of a steerable and deflectable guide wire (80) are known to those with ordinary skill in the art.
The central catheter (60), along with the bow catheter (70) and bow wires (30, 40), then tracks over the guide wire (80), so that the distal portion (52) of the mitral commissure locating system (50) is positioned across the mitral valve (6) as shown in
In an alternative embodiment, the distal portion of the mitral commissure locating system could be positioned inside a left pulmonary vein in order to stabilize the system for subsequent procedures. To achieve this, according to one embodiment of the present teachings, the bow wires are made long enough so that a proximal portion of the bow wires remain inside the left ventricle, a middle portion of the bow wires are inside the left atrium, and a distal portion of the bow wires are inside the left pulmonary vein. When deployed, as the bow wires curve radially outward, the radially expanded distal portion of the bow wire secures the distal position of the mitral commissure locating system inside the left pulmonary vein, and the radially expanded middle and proximal portions of the bow wires securely locked into the commissure as the heart contracts.
In one embodiment, by visualizing the narrow waist (38, 48) on the bow wires (30, 40), a clinician identifies the mitral valve commissure (12, 14). In another embodiment, by forming the narrow waist (38, 48) on the bow wires (30, 40), the deployed distal portion (52) of the mitral commissure locating system (50) is securely positioned across the mitral valve (6) for subsequent procedures.
In another embodiment, the bow wires of the mitral commissure locating system comprises a preformed reversed bends on the bow wires, which forms a narrow waist when deployed. In some embodiments, such reversed bends or the narrow waist fit into the mitral commissure and, as a result secure the mitral commissure locating system in the mitral annulus. Without being limited to any theory, such reversed bends/narrow waist of the mitral commissure locating system ensures a better positioning of the delivery catheter for the tissue piercing wire so that the distal end of the tissue piercing wire can be positioned close to the annulus.
In one embodiment of the present teachings, upon marking the mitral valve commissure (12, 14) by the mitral commissure locating system (50), a clinician can then advance a delivery catheter for tissue piercing wire (device) (90) distally and position it adjacent, approximate to/or against the mitral annulus (16) at the mitral valve posteromedial commissure (12) from inside the left ventricle (4), as illustrated in
Once a delivery catheter is properly positioned, a tissue piercing wire (100) is advanced relative to the delivery catheter for tissue piercing wire (90) as illustrated in
In some embodiments, the movement of a tissue piercing wire (100) is accomplished manually. Alternatively, the movement of a tissue piercing wire (100) may be automated and therefore requires additional controls such as a spring-loaded mechanism attached to the delivery.
In one embodiment, only portions of the deli very catheter for tissue piercing wire (110, 120) attaches to the bow catheter (70) and the bow wires (30, 40). In another embodiment, the entire length of the delivery catheter for tissue piercing wire (110, 120) either attaches to the bow wires (30, 40) or to the bow catheter (70). One skilled in the art should understand that the attachment between the delivery catheter for tissue piercing wire (110, 120) and the bow wires (30, 40) and the bow catheter (70) could vary according to the need of the design and function that needs to be achieved. For example, as the exemplary embodiment shown in
According to one embodiment, the delivery catheter for tissue piercing wire (110, 120) attaches to the bow wires (30, 40) and the bow catheter (70) by a mechanical means including screws, bolts, clamps, bands, wire wraps, metal forms, or the like. According to another embodiment, the delivery catheter for tissue piercing wire (110, 120) attach to the bow wires (30, 40) and the bow catheter (70) by a chemical means, including an adhesive or the like. According to another embodiment, the delivery catheter for tissue piercing wire (110, 120) attach to the bow wires (30, 40) and the bow catheter (70) by chemical means, including ultrasonic welding, laser welding, overmolding, or the like. According to another embodiment, the delivery catheter for tissue piercing wire (110, 120) attach to the bow wires (30, 40) and the bow catheter (70) by other attachment means known to those skilled in the art. Yet in another embodiment, the delivery catheter for tissue piercing wire and the bow catheter are a single continuous tubular construction with an exit port cut on the tubular wall. In another embodiment, the tissue piercing wire is slidably disposed within the single lumen and exits the exit port on the tubular wall.
In one embodiment, the delivery catheter for tissue piercing wires (110, 120) are stationarily attached to the bow catheter (70) and bow wires (30, 40). That is, the delivery catheter for tissue piercing wires (110, 120) cannot move relative to the bow catheter (70) and bow wires (30, 40). In another embodiment, the delivery catheter fix tissue piercing wires (110, 120) are slidably attached to the bow catheter (70) and bow wires (30, 40). That is, the delivery catheter for tissue piercing wires (110, 120) could slide against the bow catheter (70) and bow wires (30, 40) while still remaining attached to the bow wires (30, 40) and bow catheter (70).
In one embodiment, one delivery catheter for tissue piercing wire attaches to each of the bow wires. In another embodiment, to achieve a small delivery profile, only one delivery catheter for tissue piercing wire attaches to only one of the bow wires. Thus, the specific disclosure herein should not be viewed as limiting.
Similar to what has been described above, this embodiment of the present teachings also has an elongated delivery profile and an expanded deployed profile.
Similar to described above, especially in relation to
In one embodiment where the distal portions (118, 128) of the delivery catheter for tissue piercing wire (110, 120) stationarily attaches to the bow wires (30, 40), the deployment of the bow wire (30, 40) directs the distal portion (118, 128) of the delivery catheter for tissue piercing wire (110, 120) radially outwardly. The distal ends (112, 122) of the delivery catheter for tissue piercing wire (110, 120) are positioned adjacent, approximate to, or against the mitral annulus (16) and inside the left ventricle (4) at or near the mitral valve commissure (12, 14). Alternatively, where the distal portion (118, 128) of the delivery catheter for tissue piercing wire (110, 120) slidably attaches to the bow wires (30, 40), after the bow wires (30, 40) mark the mitral valve commissure (12, 14), the delivery catheter for tissue piercing wires (110, 120) slides distally along the bow wires (30, 40) and the bow catheter (70) so that distal ends (112, 122) are positioned adjacent, approximate to, or against the mitral annulus (16) and inside the left ventricle (4) at or near the mitral valve commissure (12, 14).
In another embodiment, as the bow wires (30, 40) are deployed, the distal ends (112, 122) of the delivery catheter for tissue piercing wires (110, 120) are positioned inside the left atrium (2). In such an event, the clinician can retract the entire mitral commissure locating system (50) along with the delivery catheter for tissue piercing wires (110, 120) proximally, so that the distal ends (112, 122) of the delivery catheter for tissue piercing wires (110, 120) are retracted back into the left ventricle (4) and positioned adjacent, approximate to, or against the mitral annulus (16). Alternatively, instead of retracting the entire mitral commissure locating system (50) and the delivery catheter for tissue piercing wires (110, 120), the delivery catheter for tissue piercing wires (110, 120) slide proximally along the bow wires (30, 40) and bow catheter (70) so that the distal ends (112, 122) are positioned approximately to the mitral annulus (16).
In another embodiment; as the bow wires (30, 40) are deployed, the distal ends (112, 122) of the delivery catheter for tissue piercing wires (110, 120) are at a position that is inside the left ventricle (4) and distant to the mitral annulus (6). In such an event, the clinician can advance the entire mitral commissure locating system (50) along with the delivery catheter for tissue piercing wires (110, 120) proximally, so that the distal ends (112, 122) of the delivery catheter for tissue piercing wires (110, 120) are advanced distally and positioned adjacent, approximate to, or against the mitral annulus (16). Alternatively, instead of advancing the entire mitral commissure locating system (50) and the delivery catheter for tissue piercing wires (110, 120), the delivery catheter for tissue piercing wires (110, 120) slide distally along the bow wires (30, 40) and the bow catheter (60) so that distal ends (112, 122) are positioned approximate to the mitral annulus (16).
In yet another embodiment, the distal ends (112, 122) of the delivery catheter for tissue piercing wires (110, 120) include one or more radiopaque markers so that they can be easily visualized by using a radiographic imaging equipment such as with x-ray, magnetic resonance, ultrasound, or fluoroscopic techniques. With the visual assistance provided by the radiopaque marker, during the deployment of the mitral commissure locating system (50), a clinician can adjust the positioning of the system (50) and the delivery catheter for tissue piercing wire (110, 120) jointly or separately, so that the distal ends (112, 122) of the delivery catheter for tissue piercing wires (110, 120) remain approximate to the mitral annulus (16).
Once the delivery catheter for tissue piercing wires are properly positioned, the tissue piercing wires are then advanced relatively to the delivery catheter for tissue piercing wire similar to what has been described above, including in
According to some embodiments, the tissue piercing wires advance inside the wire delivery lumen (116, 126) of the delivery catheter for tissue piercing wire (110, 120) and cross the annulus. According to some embodiments, the tissue piercing wires are preload inside the wire deli very lumen (116, 126) and the delivery catheter for tissue piercing wires (110, 120) having the tissue piercing wires disposed inside are then positioned at a treatment location. In some embodiments, after the delivery catheter for tissue piercing wires (110, 120) are positioned at the treatment location, the multiple tissue piercing wires then advance distally and cross the annulus. In certain embodiments, the multiple tissue piercing wires advance simultaneously. In certain embodiments, the multiple tissue piercing wires advance sequentially. In certain embodiments, the multiple tissue piercing wires advance in groups.
According to some embodiments, the distal portion of the tissue piercing wire is configured to deflect or curl back to prevent inadvertent tissue damage. The ability to deflect or curl can be achieved by the geometrical construct of the tissue piercing wire, such as a flexible distal portion, by the physical property of the material used in making the wire, or by the shape memory property of the material used in making the tissue piercing wire. Those skilled in the art would be able to incorporate known techniques and/or materials to achieve this purpose without undue experimentation.
With the tissue piercing wire crossed the mitral annulus (16) at the mitral valve commissure, the mitral commissure locating system (50) along with the delivery catheter for tissue piercing wire are then removed from the body, leaving the tissue piercing wire remain across the mitral annulus (16) and mark the mitral valve commissure.
According to one embodiment of the present teachings, two tissue piercing wires are positioned across the mitral annulus. One skilled in the art should understand that any number of tissue piercing wires can be placed with the assistant of the mitral commissure locating system.
Although the present teachings provide tissue piercing wires that are placed across the commissures, one skilled in the art should understand that tissue piercing wire can be placed not only at the commissure, but also at other locations along the annulus, for example, the P1, P2, or P3 area of the posterior annulus. For example, the path of the tissue piercing wire can be adjusted by either steering its delivery catheter or by adjusting the degree of bend of the bow wire. And subsequently, tissue anchors can be placed at the locations marked by the tissue piercing wire, and the annulus between the tissue anchors are then plicated as described below.
According to one embodiment, the bow wires transitions together from its generally straightened profile to its bend profile. In another embodiment, two bow wires can be adjusted independently of each other so that one wire can have a different degree of bend from the other wire.
According to one embodiment, the delivery catheter fix the tissue piercing wire attaches to the bow wires at its distal end. In another embodiment, the delivery catheter for the tissue piercing wire attaches to the bow catheter at the distal end of the bow catheter. In yet another embodiment, the delivery catheter for the tissue piercing wire can attach to either of the bow wires or the bow catheter at any location needed. Thus, the specific embodiments disclosed here should not be viewed as limiting.
According to one embodiment, a first tissue anchor (160) can then be deployed over the tissue piercing wires (130, 140) and across the mitral annulus (16) at the mitral valve commissures (12, 14). According to some embodiments, as illustrated in
While any first tissue anchoring devices known in the art can be used, the particular tissue anchor in the present teachings, as shown in
Examples of tissue anchors and tissue anchor delivery catheters described in conjunction with the drawings of the present teachings have some similarities to those in U.S. patent application Ser. No. 12/273,670, filed on Nov. 19, 2008, entitled Tissue Anchor and Anchoring System, U.S. patent application Ser. No. 11/174,951, filed on Jul. 5, 2005, entitled First Tissue Anchor and Anchoring System and Methods of Using the Same, U.S. patent application Ser. No. 13/777,042, filed on Feb. 26, 2013, entitled Tissue Anchor and Anchoring System, each of which is incorporated by reference herein in its entirety. Although not shown in the exemplary figures, other suitable tissue anchoring devices can also be used. Examples of suitable tissue anchoring devices include, but are not limited to, tissue fasteners, tissue pledgets, or tissue staples etc.
Still referring to
In an alternative embodiment, after the first tissue anchor (160) is deployed across the mitral annulus, a clinician cinches/deploys the distal part of the tissue anchor on the atrial side of the annulus before retracts the anchor delivery catheter and deploys the proximal part of the anchor in the left ventricle. In a particular embodiment, a clinician exposes the distal portion of the tissue anchor inside the left atrium and cinches the anchor elements of the distal portion of the tissue anchor so that they are placed against the left atrial side of the annulus. In another embodiment, a clinician exposes and cinches the proximal portion of the tissue anchor from inside the left ventricle.
With the first tissue anchor (160) securely deployed at the first mitral valve commissure across the mitral annulus (16), the clinician can deploy a second tissue anchor (170) at a second mitral valve commissure according to some embodiments of the present teachings.
According to some embodiments, a clinician can then apply tension to one or both of the tensile members (166, 176) of the first and second tissue anchors (160, 170). This tension pulls two tissue anchors (160, 170) closer to each other, thereby reducing the circumference of the mitral annulus. This tension, and the reduced distance between the two tissue anchors (160, 170), are maintained by directing a locker (184) along the tensile member (166, 176) towards the two tissue anchors (160, 170). The two wires (130, 140) and/or the two tissues anchor delivery catheters (150, 180) can then be retracted proximally and removed.
Suitable lockers include those known in the art and those described in U.S. application Ser. No. 11/753,921 filed on May 25, 2007, entitled Lockers for Surgical Tensile Members and Methods of Using the Same to Secure Surgical Tensile Members, the disclosure of which is incorporated herein by reference. With the tensile members secured by the locker, the excess tensile members proximal to the locker can be removed by a cutter, for example, a cutter disclosed in U.S. patent application Ser. No. 11/935,054, filed on Nov. 5, 2007, entitled Suture Cutter and Method of Cutting Suture, the disclosure of which is incorporated herein by reference.
A bident catheter, for example is a double lumen catheter with the distal portions of the two catheter members separating from each other and the rest portion of the two catheter members joined together. The distal portions of the two catheter members are kept close to each other during a percutaneous delivery. Once reaching the treatment location, the distal portion of the two catheter members are deployed to be radially apart from each other, either automatically by the construct of the bident catheter; or manually by a control mechanism from outside of the body. Each catheter lumen is used to deliver one tissue anchor, similar to what has been described above.
Alternatively, a tissue anchor delivery catheter with a single lumen catheter and a translation mechanism allowing catheter to be controllably moved to a second location can be used instead of a bident catheter. Examples of the delivery catheter with a translation mechanism is disclosed in U.S. Patent Application Ser. No. 61/786,373, filed on Mar. 15, 2013, entitled Translation Catheters, Systems, and Method of Use Thereof the disclosure of which is incorporated herein by reference.
In one embodiment of the present teachings, a bident tissue anchor delivery catheter (200) comprises a first catheter member (210) having a lumen (216) threaded over the first tissue piercing wire (130) at the first mitral valve commissure. Once the distal end (212) of the first catheter member (210) is positioned approximately to the mitral annulus (16) at the first mitral valve commissure, the distal portion of the second catheter member (220) is deployed radially and laterally away from the distal portion of the first catheter member (210). In one embodiment, the distal end (222) of the second catheter member (220) directs generally to the mitral annulus (16) at the P3 region generally along the posterior mitral annulus (16b), as illustrated in
Similar to what has been described above, according to some embodiments, a clinician can then apply tension to one or both of the tensile members (166, 236) of the two tissue anchors (160, 230). This tension pulls two tissue anchors (160, 230) closer to each other, thereby plicating the annulus between the two tissue anchors (160, 230). This tension and the reduced distance between the two tissue anchors (160, 230) are maintained by directing a locker (238) along the tensile members (166, 236) towards the two tissue anchors (160, 230), as illustrated in
According to some embodiments, similar to what is described in
Without limiting the present teachings to any particular theory, the commissure areas have generally better structures than other areas since they are closer to the fibrous skeleton of the heart and, therefore may provide a stronger base to pull the dilated posterior annulus in the antero-posterior direction. Mitral annulus plication with one tissue anchor placed at a commissure provides a significant dimensional change in the antero-posterior direction which, without limiting the present teachings to any particular theory, is generally thought to be important for correcting a mitral regurgitation caused by a dilated annulus. In various embodiments of the present teachings the mitral commissure locating system uses the anatomical geometry of a heart for precisely placing tissue anchors described in the present application. Using the mitral commissure locating system allows positioning of the tissue anchor in a position similar to the Kaye Annuloplasty surgical procedure.
The mitral commissure locating system (50) disclosed herein is useful for delivering positioning wires and tissue anchors across the mitral annulus (16) at the mitral commissure and plicating the mitral annulus without potentially being caught by the tendinous chords during the process. One skilled in the art will further recognize that the present teachings could be used to reshape the tricuspid annulus or other heart valve annulus.
Although the present teachings disclose deployments of tissue anchors over a wire place across the mitral annulus, one skilled the in art should understand that tissue anchors can also be delivered with a tissue anchor delivery catheter tracking along the bow wires of the mitral valve commissure locating system as disclosed above. Thus, the specific step of the tissue anchor deployment is subject to change as needed by a person with ordinary skill in the field. Specific embodiments disclosed in the present teachings should not be viewed as limiting.
Various embodiments have been illustrated and described herein by way of examples, and one of ordinary skill in the art will appreciate that variations can be made without departing from the spirit and scope of the present teachings. The present teachings are capable of other embodiments or of being practiced or carried out in various other ways, for example in combinations. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this present teachings belong, Methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present teachings. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.
The present application is a Continuation of U.S. patent application Ser. No. 16/123,759 to Alexander et al., filed Sep. 6, 2018, which is a Divisional of U.S. patent application Ser. No. 14/472,867, to Alexander et al., filed Aug. 29, 2014 (now U.S. Pat. No. 10,070,857), which is based on and claims priority to U.S. Provisional Patent Application 61/872,704 to Alexander et al., filed, Aug. 31, 2013, all of which are incorporated by reference, as if expressly set forth in their respective entireties herein.
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