Patent Grant
12102531
The present invention relates generally to medical methods, devices, and systems. In particular, the present invention relates to methods, devices, and systems for the endovascular, percutaneous or minimally invasive surgical treatment of bodily tissues, such as tissue approximation or valve repair. More particularly, the present invention relates to cutting of leaflet tissue in preparation of subsequent implanting of a medical implant through minimally invasive procedures.
Surgical repair of bodily tissues often involves tissue approximation and fastening of such tissues in the approximated arrangement. When repairing valves, tissue approximation includes coapting the leaflets of the valves in a therapeutic arrangement which may then be maintained by fastening or fixing the leaflets. Such coaptation can be used to treat regurgitation which most commonly occurs in the mitral valve.
Mitral valve regurgitation is characterized by retrograde flow from the left ventricle of a heart through an incompetent mitral valve into the left atrium. During a normal cycle of heart contraction (systole), the mitral valve acts as a check valve to prevent flow of oxygenated blood back into the left atrium. In this way, the oxygenated blood is pumped into the aorta through the aortic valve. Regurgitation of the valve can significantly decrease the pumping efficiency of the heart, placing the patient at risk of severe, progressive heart failure.
Mitral valve regurgitation can result from many different mechanical defects in the mitral valve or the left ventricular wall. The valve leaflets, the valve chordae which connect the leaflets to the papillary muscles, the papillary muscles themselves or the left ventricular wall may be damaged or otherwise dysfunctional. Commonly, the valve annulus may be damaged, dilated, or weakened, limiting the ability of the mitral valve to close adequately against the high pressures of the left ventricle.
One treatment for mitral valve regurgitation relies on valve replacement or repair including leaflet and annulus remodeling, the latter generally referred to as valve annuloplasty. One technique for mitral valve repair which relies on suturing adjacent segments of the opposed valve leaflets together is referred to as the “bow-tie” or “edge-to-edge” technique. While all these techniques can be effective, they usually rely on open heart surgery where the patient's chest is opened, typically via a sternotomy, and the patient placed on cardiopulmonary bypass. The need to both open the chest and place the patient on bypass is traumatic and has associated high mortality and morbidity.
In some patients, a fixation device can be installed into the heart using minimally invasive techniques. The fixation device can hold the adjacent segments of the opposed valve leaflets together and may reduce mitral valve regurgitation. One such device used to clip the anterior and posterior leaflets of the mitral valve together is the MitraClip® fixation device, sold by Abbott Vascular or Abbott Structural Heart, Santa Clara, Calif., USA.
However, sometimes after a fixation device is installed, undesirable mitral valve regurgitation can still exist, or can arise again. Further, other problems with the heart may arise that can make it desirable for the fixation device to be disabled or removed, usually in order that other procedures may be performed on the heart.
Current techniques for removing or disabling mitral valve fixation devices usually rely on open heart surgery where the patient's chest is opened, typically via a sternotomy, and the patient placed on cardiopulmonary bypass, which can pose a high risk of complications and extended patient recovery times.
For these reasons, it would be desirable to provide alternative and additional methods, devices, and systems for removing or disabling previously installed fixation devices. Such methods, devices, and systems should preferably not require open chest access and be capable of being performed either endovascularly, i.e., using devices which are advanced to the heart from a point in the patient's vasculature remote from the heart, or by another minimally invasive approach. The methods, devices, and systems may be useful for repair of tissues in the body other than heart valves. At least some of these objectives will be met by the inventions described hereinbelow.
The present disclosure describes methods, devices and systems that may be employed to detach a previously sutured “bowtie” or implanted device that clips together the anterior and posterior leaflets of a valve from one or all of the leaflets. The technology described and claimed herein could also be adapted to selectively target and cut tissue in other areas of the human anatomy via similar endovascular procedures.
These and other objects and features of the present disclosure will become more fully apparent from the following description and appended claims, or may be learned by the practice of the embodiments of the invention as set forth hereinafter.
To further clarify the above and other advantages and features of the present disclosure, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only illustrated embodiments of the invention and are therefore not to be considered limiting of its scope. Embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
As mentioned earlier, sometimes, after installation of an edge-to-edge repair device, such as a suture “bow-tie” or fixation device, in the heart, it needs to be removed or at least detached from one or both of anterior and posterior leaflets. Ordinarily, this has been done during a high-risk invasive procedure such as open-heart surgery. The presently described system 100, and associated devices and methods, however, allow a physician or clinician to address heart problems in a minimally invasive procedure.
For ease of explanation,
Several structural defects in the heart can cause mitral valve regurgitation. Regurgitation occurs when the valve leaflets do not close properly allowing leakage from the ventricle into the atrium. As shown in
Various fixation devices are used for grasping, approximating and fixating tissues, such as valve leaflets, to treat cardiac valve regurgitation, particularly mitral valve regurgitation. Certain fixation devices are described in in U.S. Pat. No. 7,563,267, which is incorporated herein by this reference. The fixation devices may rely upon the use of an interventional tool that is positioned near a desired treatment site and used to grasp the target tissue. In endovascular applications, the interventional tool is typically an interventional catheter. In surgical applications, the interventional tool is typically an interventional instrument. Fixation of the grasped tissue is accomplished by maintaining grasping with a portion of the interventional tool which is left behind as an implant. The fixation devices are well adapted for the repair of valves, especially cardiac valves such as the mitral valve.
Referring to
The fixation device 14 (sometimes also referred to herein as a “suture ‘bow-tie’” or an “edge-to-edge repair device”) is releasably attached to the shaft 12 of the interventional tool 10 at its distal end. When describing the devices of the invention herein, “proximal” shall mean the direction toward the end of the device to be manipulated by the user outside the patient's body, and “distal” shall mean the direction toward the working end of the device that is positioned at the treatment site and away from the user. With respect to the mitral valve, proximal shall refer to the atrial or upstream side of the valve leaflets and distal shall refer to the ventricular or downstream side of the valve leaflets.
The fixation device 14 typically comprises proximal elements 16 (or gripping elements) and distal elements 18 (or fixation elements) which protrude radially outward and are positionable on opposite sides of the leaflets LF as shown to capture or retain the leaflets therebetween. The proximal elements 16 are preferably comprised of cobalt chromium, nitinol or stainless steel, and the distal elements 18 are preferably comprised of cobalt chromium or stainless steel, however any suitable materials may be used. The fixation device 14 is coupleable to the shaft 12 by a coupling mechanism 17. The coupling mechanism 17 allows the fixation device 14 to detach and be left behind as an implant to hold the leaflets together in the coapted position.
In some situations, it may be desired to reposition or remove the fixation device 14 after the proximal elements 16, distal elements 18, or both have been deployed to capture the leaflets LF. Such repositioning or removal may be desired for a variety of reasons, such as to reapproach the valve in an attempt to achieve better valve function, more optimal positioning of the device 14 on the leaflets, better purchase on the leaflets, to detangle the device 14 from surrounding tissue such as chordae, to exchange the device 14 with one having a different design, or to abort the fixation procedure, to name a few. To facilitate repositioning or removal of the fixation device 14 the distal elements 18 may be released and optionally inverted to a configuration suitable for withdrawal of the device 14 from the valve without tangling or interfering with or damaging the chordae, leaflets or other tissue. According to another embodiment, any of the endovascular methods described herein for disabling or removal of the fixation device may also be used.
Once the leaflets are coapted in the desired arrangement, the fixation device 14 is then detached from the shaft 12 and left behind as an implant to hold the leaflets together in the coapted position.
Additional examples of interventional tools and systems and fixation devices are described in in U.S. Pat. No. 7,563,267, which is incorporated herein by this reference.
Sometimes, after construction of the suture “bow-tie” or installation of one or more fixation devices in the heart, it needs to be removed or at least detached from one or both of anterior and posterior leaflets. Ordinarily, this has been done during an invasive procedure such as open-heart surgery. Invasive procedures such as these often have high risk of complications. Further, sometimes mitral valve fixation devices, or the suture “bow-tie,” are installed on patients for whom open-heart or more invasive procedures are otherwise unnecessary or undesirable. For these patients, and even for patients in whom open-heart surgery is used, it would be beneficial to have devices and systems specifically designed for removing or at least detaching the suture “bow-tie” or fixation devices from one or both of anterior and posterior leaflets within an endovascular procedure, rather than a procedure requiring open heart access.
Minimally invasive systems, methods, and devices for removing or at least detaching the suture “bow-tie” or fixation devices from one or both of anterior and posterior leaflets are disclosed herein. These minimally invasive systems, methods, and devices allow a practitioner to remove or at least detaching the suture “bow-tie” or fixation devices from one or both of anterior and posterior leaflets and, optionally, then proceed to do perform other medical procedures in the heart, without necessarily requiring open heart access or other more invasive procedures. Such systems, methods, and devices are configured to be effective even if the suture “bow-tie” or fixation device has been installed for weeks, months, or years, such that tissue surrounding the device may have grown over, into, or around the suture “bow-tie” or fixation device.
An embodiment of the present invention discloses systems that can include guidewires, catheters and other components that can perform various specific functions, and also multifunctional catheters that can perform any combination of functions. Such functions may include holding or retaining an installed fixation device or the suture “bow-tie”; cutting a leaflet or leaflets; removing the suture “bow-tie” or a fixation device; and repairing the leaflet(s). Related methods for performing such functions are also disclosed.
The mitral valve may be accessed using the systems, methods, and devices disclosed and/or claimed herein either surgically or by using endovascular techniques, and either by a retrograde approach through the ventricle or by an antegrade approach through the atrium, as described above. For illustration purposes, an antegrade approach is described.
The devices and associated methods and systems described herein may be used in combination with imaging modalities such as x-ray, fluoroscopy, echocardiography, charge coupled device cameras, complementary metal oxide semiconductor cameras, magnetic resonance imaging, and other imaging modalities. The availability of such imaging modalities during such procedures may help practitioners visualize, for example, where the fixation devices are, how they are connected to the heart, and where to direct the various catheters and/or other devices.
As illustrated, the system 100 can take the form of an elongate member 102, such as a multicomponent catheter, which is adapted to be advanced through a patient's vasculature. Elongate member or catheter 102 can include a guiding catheter 110 through which a delivery catheter 120 can be advanced to a previously implanted edge-to-edge repair device (not shown). The guiding catheter 110 can be, in one configuration, a steerable catheter or introducer, such as a Steerable Introducer sold under the trademark AGILIS.
The guiding catheter 110 can be steered through the tortuous anatomy to the heart and, using a transseptal approach, advanced through the septum between the right and left atria toward the mitral valve (MV). Once in place, the guiding catheter 110, whether alone or in combination with the delivery catheter 120, can position a distal end 122 of the delivery catheter 120 relative to the mitral valve (MV) for performing edge-to-edge repair device detachment as described herein. The steerability of guiding catheter 110 can be achieved through any number of known structures and methods, including but not limited to those disclosed in U.S. Pat. No. 7,653,267. In some embodiments, delivery catheter 120 can also move axially relative to the guide catheter. In other embodiments, a distal end portion of delivery catheter 120 can also be steerable independent of, and in a different plane from, guiding catheter 110.
The delivery catheter 120 accommodates a capturing member 140 and a cutting member 150 that extends from a proximal end 124 to the distal end 122. The capturing member 140, such as a snare, is used to capture and aid with positioning a cutting region of the cutting member 150 relative to the tissue to be cut to detach the edge-to-edge repair device from the leaflets LF. As discussed in additional detail below, withdrawing the capturing member 140 into the delivery catheter 120, while at the same time advancing the cutting member 150, provides the desired looping and positioning of the cutting member 150 so that the cutting region of the cutting member 150 can be used to cut the leaflets.
To aid with such capturing, as illustrated in
While
The capturing member 140 can be a wire, tubular member, or other elongate structure and can be made of metal, plastic, shape-memory alloys or polymers, or any suitable material, e.g., such as those described herein (e.g., cobalt-chromium alloys, stainless steel, nickel-titanium, Elgiloy®, etc.
A distal end portion of capturing member 140 can include a pre-formed, resilient, shape-memory loop configuration and/or orientation, such as looped portion 144. The loop can collapse and straighten when held within the constraints of the delivery catheter 120. Once advanced distally beyond the distal end of the delivery catheter 120, the loop can self-expand and return to its pre-formed, shape-memory configuration and orientation.
Capturing member 140 can also include one or more radiopaque markers positioned adjacent and/or around the looped portion 144. As discussed in additional detail below, such radiopaque markers assist in locating and visualizing the location, position and orientation of such capturing member 140 and cutting member 150, as well as their respective locations, positions and orientations relative to one another.
The cutting member 150 can electrically communicate with an electrosurgical device 130 (such as an electrosurgical generator), which can selectively provide radio-frequency energy to the cutting member 150. The cutting member 150, therefore, can function as a probe electrode that can cut, coagulate, desiccate, and fulgurate tissue, such as the leaflets LF. More particularly, the cutting member 150 can be used to cut at least a portion of at least one of the anterior and posterior leaflets LF or other tissue to which the edge-to-edge repair device is coupled.
The cutting member 150 can include a conductive core 158 with an electrically insulating coating 160 formed over at least a portion of the core 158. In some configurations the cutting member 150 is a guide wire that includes a proximal end 154 that can be electrically connected or coupled to an electrosurgical device 130, which can be used to selectively apply electrical energy to cutting member 150. The electrical cooperation can occur through an uncoated or exposed portion 159 at the proximal end 154 of core 158, which can be connected to electrosurgical device 130. Additional details regarding the cutting member 140 will be provided in connection with
Portions of capturing member 140 and cutting member 150 can also include good torque characteristics. In other words, when rotational forces are applied at their respective proximal ends to cause rotational movement at the proximal ends, such rotational movement is translated relatively closely to the respective distal ends. In this manner, the relative positioning and orientation of the distal end of capturing member 140 (including any pre-formed bends or curves and/or loop 144) and the distal end of cutting member (including any pre-formed bends or curves) can be closely correlated to the rotational position of the corresponding proximal ends thereof.
System 100 can also include a handle or fixture, schematically illustrated at 112, located at or near the proximal end 124 of system 100. Handle or fixture 112 can incorporate any number of known structures and methods for manipulating and controlling the advancing, withdrawing, positioning and orienting of the various components of system 100, including, but not limited to, guiding member 110, delivery catheter 120, capturing member 140, cutting member 150 and other components and sub-components of system 100, relative to a patient's anatomy and/or relative one another.
Each illustrated cutting member 150a-150d has a proximal end 154a-154d and a distal end 152a-152d. Formed at the distal end 152a-152d is an atraumatic tip 156a-156d that can be formed, in one configuration, from a coil. This atraumatic tip 156a-156d can be shaped by a physician or clinician using the cutting member 150 or can have a preformed shape to aid with positioning the cutting member 150 relative to the edge-to-edge repair device, leaflets, and the orifices O formed by the edge-to-edge repair device and the leaflets. The coil can be formed of a metal or alloy, or other deformable or resiliently deformable material.
Each cutting member 150a-150d has a conductive core 158a-158d and a coating 160a-160d disposed over the conductive core 158a-158d. The coating 160a-160d partially covers the conductive core 158a-158d, except for one or more bare regions 162a-162d where the conductive core 158a-158d is uncoated or exposed. These regions 162a-162d allow radio-frequency energy to be delivered from the conductive core 158a-158d or for such energy to be delivered to tissue contacting those regions 162a-162d to cut, coagulate, desiccate, and fulgurate the tissue. For instance, in
In addition to the conductive core 158a-158d and the coating 160a-160d, each cutting member 150a-150d includes radiopaque markers 164a-164d. These markers 164a-164d define the peripheral bounds of the cutting regions 162a-162d and aid in positioning those regions of the cutting member 150a-150d. For instance, the markers 164a-164d can be viewed via fluoroscopy, x-ray, or other imaging technique. While the markers 164a-164d are illustrated defining the bounds of the cutting regions 162a-162d, other markers can be included to define other locations of the cutting member 150a-150d or any other part of the system 100 or relationship between two or more parts of the system 100.
Referring to
In one particular embodiment, the electrically conductive core 158d can be made of surgical quality steel and can have a diameter of approximately 0.014″ (or approximately 0.04 cm) at its proximal end and a diameter of approximately 0.005″ (or approximately 0.01 cm) to approximately 0.008″ (or approximately 0.02 cm) in the cutting region(s) 162d. Alternatively, a proximal portion of the cutting member could also be formed from a hypotube. Cutting member 150d can have an overall length of approximately 70″ (or approximately 180 cm), with a cutting region 162d of approximately 4″ (or approximately 10 cm) in length, and the atraumatic tip can be approximately 0.4″ (or approximately 1 cm) to approximately 1.2″ (or approximately 3 cm) in length.
The cutting member 150 can be a wire, tubular member, or other elongate structure, with the conductive core being made of a metal, alloy, conductive polymer, or other conductive material. The coating for the cutting member 150 can be a polymer, such as polyterafluoroethylene or other polymer, a hydrophilic coating, a composite material, or other material the can provide lubricity to the cutting member and/or insulative properties to limit unwanted electrical conductivity of the conductive core with the tissue or the other components of the system 100.
Turning to
The lumens 126 and 128 can extend from luer connectors 170 and 172, through extension tubular members 174 and 174, which can join the luer connectors 170 and 172 to a reminder of the delivery catheter 120, to the distal end 122. These lumens 126 and 128 can be formed during extrusion of the shaft 125 of the delivery catheter 120 when the shaft 125 is formed of a polymer or other material capable of being extruded. For instance,
As shown in
In addition to the shaft 125 and the lumens 126 and 128 having different cross-section, the distal end 122 of the shaft 125 can also have different configurations. For instance, as shown in
In addition to having the lumens 126 and 128 being formed from the material forming the shaft 125, such as when polymers are assembled to form the shaft 125, it is possible to include separate tubular members that are slidable relative to each other and/or relative to the shaft 125. This provides enhanced positioning capabilities for the delivery catheter 120 because each tubular member is independently advanceable and also independently positionable relative to the distal end 122 of the delivery catheter 120 and the mitral valve MV. Such a structure is illustrated in
Illustrated in
The tubular members 180 and 182 can be moved forward and backward, or proximal and distal, relative to a shaft shell 186. Tubular members 180 and 182 can also move axially relative to, and independent of, one another. This allows for enhanced positioning of the distal ends of tubular members 180 and 182 (and, thus, enhanced positioning of capturing member 140 and cutting member 150) relative to the mitral valve MV during the procedure. For instance, the distal end of the tubular member 182 can be closer to the mitral valve MV than the distal end of the tubular member 180 during the procedure, or vice versa, to change the angle at which the looped portion 144 receives the distal end 152 of the cutting member 150. To further enhance the capabilities of the tubular members 180 and 182, one or both can be pre-formed with a resilient, pre-formed shape-memory curve or bend to aid with steerability and positioning of the distal ends of the tubular members 180 and 182 at desired locations within the heart. Thus, the positioning of the delivery catheter 120e and/or the distal ends of the various elements of capturing member 140 and cutting member 150 can be achieved by the steerability of the guiding catheter 110, pre-formed, shape-memory curves or bends in tubular members 180 and 182, or any combination thereof. In addition, a distal portion of the delivery catheter 120e could also be made to be independently steerable once it is advanced beyond the distal end of guiding catheter 110.
Alternatively, as illustrated in
Generally, the shaft and other portions of the delivery catheters 120 can be fabricated from polymers, metals, alloys, combinations thereof, or other materials that can accommodate the manufacture of the delivery catheter.
Illustrated in
The delivery catheter 120g of
The system 100 can be used to position the delivery catheter 120 in various spaces within a patient's anatomy. For instance, and as will be described herein, the system 100 can be used to position the capturing member 140 and the cutting member 150 relative to leaflets in apposition to an edge-to-edge repair device, such as the MitraClip® or a suture “bow-tie.” However, the presently described system 100 and associated methods and devices can be used for other valvular structures or other tissues in an anatomy.
The positioning and deployment of the leaflet cutting device is more particularly illustrated in
With an end of the guiding catheter 110 facing the edge-to-edge repair device, the distal ends of lumens 126 and 128 can be positioned through orifices 0 on either side of edge-to-edge repair device. For instance, where the embodiment shown in
With the delivery catheter 120 so positioned, the capture member 140 can be advanced from the lumen 128 (and from the tubular member 182) into the left ventricle. By so doing, the looped portion 144 can self-expand to form a ring or opening (as shown in
When the position of the cutting member 150 is verified through comparing the location of the radiopaque markers 164 against radiopaque markers formed on the proximal and distal ends of the looped portion 144, the capture member 140 can be withdrawn towards the deliver catheter 120, and the lumen 126 as illustrated in
Following positioning of the cutting member 150, the leaflet can be cut by applying electrical energy to the cutting member 150 and drawing the exposed cutting regions 162 through the leaflet tissue, as illustrated in
In an alternate approach, schematically illustrated in
This alternate approach, using the delivery catheter 120f, is schematically illustrated in
With the capture member 140 in place, i.e., the looped portion 144 self-expands to form a ring or opening with which to receive the cutting members 150a and 150b, the two tubular members 180a and 180b are advanced to position the distal ends of tubular members 180a and 180b through orifices O on either side of the edge-to-edge repair device 18, as shown in
When the position of the cutting members 150a and 150b are verified through comparing the location of the radiopaque markers 164 against radiopaque markers formed on the proximal and distal ends of the looped portion 144, the capture member 140 can be withdrawn towards the deliver catheter 120, and the lumen 126, as shown in
Once the edge-to-edge repair device 18 is successfully detached from a first one of the leaflets, then a physician or clinician can move onto performing other procedures. Alternatively, if it is desirable or necessary to completely remove the edge-to-edge repair device 18, delivery catheter 120f can also be used to sequentially cut the edge-to-edge repair device 18 from both leaflets of the mitral valve. In other words, delivery device 120f can first be deployed in the manner discussed above to cut one leaflet and then be subsequently deployed in a similar manner to cut the other leaflet. In either event, the physician or clinician can then move on to perform one or more of a mitral valve annuloplasty, balloon valvuloplasty, mitral valve repair, installation of a replacement valve, and combinations thereof.
The technology described and claimed herein could also be readily adapted to selectively target and cut tissue in other areas of the human anatomy via similar endovascular procedures.
In keeping with the foregoing embodiments and disclosure, the technology disclosed herein can be directed to systems, devices and methods for at least partially detaching an edge-to-edge repair device that holds together anterior and posterior leaflets of a mitral valve of a human heart. For example, the devices are directed to at least partially detaching an edge-to-edge repair device that holds together anterior and posterior leaflets of a mitral valve of a human heart and can include one or more of the following elements: an elongate member having a proximal end, a proximal end portion, a distal end portion and a distal end, the elongate member; a guiding catheter with a distal end portion that can be selectively bent to reorient the distal end portion of the elongate member; a delivery catheter coaxially located within the guiding catheter; a delivery catheter shell having a first lumen and a second lumen, each extending from a proximal end to a distal end of the delivery catheter shell; a first tubular member having a distal end portion and positioned within the first lumen and being moveable in an axial direction relative to the delivery catheter shell; a second tubular member having a distal end portion and positioned within the second lumen and being moveable in an axial direction relative to the delivery catheter shell; a capture member extending through the first tubular member and being movable in an axial direction relative to the first tubular member, the capture member having a self-expanding, shape-memory loop formed at a distal end thereof; and/or a first cutting member extending through the second tubular member and being movable in an axial direction relative to the second tubular member, the first cutting member comprising an electrically conductive core extending its entire length, an electrically insulative coating covering a major portion of the conductive core, and one or more uncoated, electrically conductive cutting regions. The devices can also include one or more of the following additional features: wherein one or both of the first and second tubular members include a preferential, shape-memory bend in the distal end portion thereof; wherein the cutting member comprises a first cutting region and a second cutting region, wherein the first cutting region is disposed at a proximal end of the cutting member and the second cutting region is disposed between the proximal end and a distal end of the cutting member; wherein the first cutting region is disposed at and forms a distal end of the cutting member, proximal of an atraumatic coil tip; wherein the cutting member further comprises one or more radiopaque markers defining peripheral bounds of the cutting regions; wherein the capture member comprises a self-expanding, shape-memory loop portion for capturing the cutting member; wherein the loop portion comprises a narrowed portion configured to facilitate preferential collapsing of the capture member upon drawing the capture member into the second tubular member; and/or wherein the capture member further comprises one or more radiopaque markers defining peripheral bounds of the loop portion.
Similarly, the methods can be directed to at least partially detaching an edge-to-edge repair device that holds anterior and posterior leaflets of the mitral valve together, wherein a first orifice in the mitral valve is located to one side of the edge-to-edge repair device and a second orifice in the mitral valve is located to an other side of the edge-to-edge repair device, and can include, for example, any one or more of the following steps or acts: advancing a capture member from a first catheter portion that extends from a distal end of a delivery catheter and through the first orifice; advancing a cutting member from a second catheter portion that extends from the distal end of the delivery catheter and through the second orifice; capturing the cutting member with the capture member and positioning the cutting member around a portion of one of the leaflets of the mitral valve adjacent to the edge-to-edge repair device; and/or cutting at least a portion of one of the leaflets adjacent to the edge-to-edge repair device to detach the edge-to-edge repair device from the at least one of the anterior or posterior leaflets.
In another embodiment, the methods can include any one or more of the following steps or acts: advancing an elongate member through a least a portion of the vasculature of a patient and into a left atrium of a patient's heart, the elongate member having a proximal end portion, distal end portion and a distal end, the proximal end portion being located and accessible outside the patient's vasculature, the elongate member having a guiding catheter with a distal end portion that can be selectively bent to reorient the distal end portion of the elongate member, the elongate member also having a delivery catheter coaxially located within the steering catheter, the delivery catheter having a first lumen and a second lumen, each extending from a proximal end to a distal end of the delivery catheter, the delivery catheter also having a capture member extending through the first lumen and cutting member extending through the second lumen; puncturing, with the distal end of the elongate member, a septal wall between the right atrium and a left atrium of the heart and advancing the distal end portion of the elongate member into the left atrium of the heart; bending the distal end portion of the steering catheter to direct the distal end portion of the elongate member toward the mitral valve and align the delivery catheter with the edge-to-edge repair device; advancing the capture member beyond the distal end of the delivery catheter and through the first orifice; advancing the cutting member beyond the distal end of the delivery catheter and through the second orifice; capturing a distal end portion of the cutting member with a distal end portion of the capture member; withdrawing the distal end portion of the capture member in a proximal direction through the first lumen to position a cutting region formed in the cutting member around a portion of one of the anterior or posterior leaflets of the mitral valve adjacent to the edge-to-edge repair device; and/or applying electrical energy to the cutting member to cause the cutting region to cut through a portion of the tissue of one of the anterior and posterior leaflets adjacent to the edge-to-edge repair device to detach the edge-to-edge repair device from the at least one of the anterior or posterior leaflets.
Further still, the methods can also include any one or more of the following additional steps or acts: advancing a distal end portion of the capture member beyond a distal end of the first catheter portion, the distal end portion of the capture member having a self-expanding, shape-memory loop, and allowing the self-expanding, shape-memory loop to deploy on a ventricular side of the mitral valve; advancing a distal end portion of the cutting member beyond a distal end of the second catheter portion and through the loop of the capturing member; withdrawing the capturing member in a proximal direction and causing the loop to snare the cutting member and draw it around the edge-to-edge repair device and into contact with a portion of the tissue of the leaflet between the first and second orifices and adjacent to the edge-to-edge repair device; withdrawing the capture member in a proximal direction until one of the electrically conductive cutting regions passes around and is positioned against the tissue of the leaflet adjacent the edge-to-edge repair device; advancing the cutting member in a distal direction to aid in positioning one of the electrically conductive cutting regions against the tissue of the leaflet adjacent the edge-to-edge repair device; applying electrical energy to the cutting member; positioning the first catheter portion in the first orifice and positioning the second catheter portion in the second orifice; positioning the first catheter portion in the first orifice by sliding the first catheter portion within a body of the delivery catheter; positioning the second catheter portion in the second orifice by sliding the second catheter portion within a body of the delivery catheter; positioning the first catheter portion independently of positioning a second catheter portion; positioning the first catheter portion relative to the second catheter portion by moving the first catheter portion away from the second catheter portion; positioning the first catheter portion relative to the second catheter portion, wherein the first catheter portion and the second catheter portion are formed at the distal end of the delivery catheter, the delivery catheter comprising a split portion that allows the first catheter portion to extend away from the second catheter portion; performing a procedure selected from the group consisting of mitral valve annuloplasty, balloon valvuloplasty, mitral valve repair, installation of a replacement valve, and combinations thereof; and/or withdrawing the snare into the second catheter portion while advancing the cutting member from the first catheter portion to vary a length of the cutting member exposed to the anterior and posterior leaflets.
The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.
This application claims the benefit of priority based on U.S. Provisional Patent Application Ser. No. 62/748,947, filed Oct. 22, 2018 and entitled “Leaflet Cutting Devices and Methods.”
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