JP4282994B2 - Method and apparatus for catheter-based annuloplasty using local plication - Google Patents

Description

(Cross-reference of related applications)
The present invention is a co-pending U.S. patent application Ser. No. 09 / 841,968, filed Apr. 24, 2001, entitled “Method and Apparatus for Catheter-Based Annuloplasty” (which is incorporated herein in its entirety). Partial continuation), which is incorporated by reference.

(Background of the Invention)
(1. Field of the Invention)
The present invention relates generally to techniques for treating mitral valve dysfunction, such as mitral valve leakage. More specifically, the invention relates to systems and methods for treating leaky mitral valves in a minimally invasive manner.

(2. Description of related fields)
Congestive heart failure (CHF), which often involves dilation of the heart, is a leading cause of death. As a result, the market for the treatment of CHF is increasingly expanding. For example, the treatment of CHF is a major expense of medical insurance and national medical security dollars in the United States. Typically, CHF treatment allows a large number of people with CHF to enjoy an improved quality of life.

  Referring initially to FIG. 1, the anatomy of the heart, particularly the left side of the heart, is described. The left side of the heart 104 includes a left atrium 108 and a left ventricle 112. The aorta 114 receives blood from the left ventricle 112 through the aortic valve 120, which acts to prevent blood from flowing back into the left ventricle 112. The mitral valve 116 is located between the left atrium 108 and the left ventricle 112 and effectively controls blood flow between the left atrium 108 and the left ventricle 112.

  The mitral valve 116 (which will be described in more detail below with respect to FIG. 2a) is coupled to a chord 124 that serves as a “tension member” that prevents the cusps of the mitral valve 116 from unintentionally opening. Including anterior and posterior cusps. When the left ventricle 112 contracts, the chordae 124 cause the anterior leaflet to open upward until its movement is limited by the chordae 124. Usually, the restriction above the opening corresponds to the contact between the front leaflet and the back leaf and the prevention of backflow. The chords 124 arise from the meat column 128, more specifically from the papillary muscles of the meat column 128.

  The left ventricle 112 includes trabeculae 132 that are fibrous cords of connective tissue associated with the wall 134 of the left ventricle 112. Trabecular 132 is also associated with a ventricular septum 136 that separates left ventricle 112 from the right ventricle (not shown) of heart 104. The trabeculae 132 is generally located below the meat column 128 in the left ventricle 112.

  FIG. 2 a is a cutaway top perspective view of the mitral valve 116 and the aortic valve 120. The aortic valve 120 has a valve wall 204 surrounded by a skeleton 208a of fibrous material. The skeleton 208a can generally be viewed as a fibrous structure that effectively forms a ring around the aortic valve 120. A fibrous ring 208b that is substantially the same type structure as the skeleton 208a extends around the mitral valve 116. The mitral valve 116 includes an anterior leaflet 212 and a posterior leaflet 216 as described above. The anterior leaflet 212 and the posterior leaflet 216 are generally thin and flexible membranes. When the mitral valve 116 is closed (as shown in FIG. 2a), the anterior leaflet 212 and the posterior leaflet 216 generally align and contact each other to form a seal. Alternatively, when the mitral valve 116 is open, blood can flow through an opening formed between the anterior leaflet 212 and the posterior leaflet 216.

  Many problems with the mitral valve 116 can occur and these dysfunctions can cause many types of illness. Such problems include, but are not limited to, mitral regurgitation. Mitral regurgitation or leakage is the regurgitation of blood from the left ventricle 112 to the left ventricle 108 due to incomplete closure of the mitral valve 116. That is, leakage often occurs when a gap is formed between the front leaflet 212 and the back leaflet 216.

  In general, a relatively significant gap may exist between the anterior leaflet 212 and the posterior leaflet 216 (as shown in FIG. 2b) for a variety of different reasons. For example, a gap may be present due to congenital malformations, due to ischemic disease, or because the heart has been damaged by a previous heart attack. Gaps can also occur when congenital heart failure (eg, cardiomyopathy) or some other type of pain causes dilation of the heart. When the heart is dilated, the heart wall (eg, left ventricular wall 134) may stretch or dilate, causing the posterior leaflet 216 to stretch. It should be understood that the anterior leaflet 212 generally does not stretch. As shown in FIG. 2b, a gap 220 between the anterior leaflet 212 and the extended posterior leaflet 216 'is created when the wall 134' is extended. Thus, due to the presence of the gap 220, the mitral valve 116 cannot close properly and may begin to leak.

  Because leakage through the mitral valve 116 generally makes the heart less effective, the heart must work harder to maintain an adequate amount of blood flow through the heart. Leakage through the mitral valve 116, or general mitral valve dysfunction, is often considered a precursor to CHF. In general, there are different levels of symptoms associated with heart failure. Such levels are classified by the New York Heart Association (NYHA) basic classification system. This level ranges from the class 1 level (this is the level for asymptomatic patients who have virtually no physical restrictions) to the class 4 level (which can perform any physical activity without discomfort. To the level for patients with heart failure symptoms even at rest). In general, correction for mitral valve leakage may be successful in allowing the patient's grade of NYHA classification to be reduced. For example, a patient with a class 4 classification may reduce that classification to class 3, and thus may be relatively comfortable at rest.

  The procedure used to correct for mitral valve leakage or more specifically CHF is typically a highly invasive open heart surgical procedure. A ventricular assist device (eg, an artificial heart) can be implanted in a patient with a defective heart. Implantation of ventricular assist devices is often expensive and patients with ventricular assist devices must receive extended anticoagulant therapy. As will be appreciated by those skilled in the art, anticoagulant therapy reduces the risk of clots forming, for example, in ventricular assist devices. While it is desirable to reduce the risk of blood clots associated with ventricular assist devices, anticoagulant therapy can increase the risk of unwanted uncontrollable bleeding (eg, as a result of a fall) in a patient .

  Rather than implanting a ventricular assist device, a biventricular pacing device similar to a pacemaker can be implanted in some cases (eg, when the heart beats ineffectively in a particular asynchronous manner). Although implantation of a biventricular pacing device can be effective, not all heart patients are suitable for receiving a biventricular pacing device. Furthermore, implantation of biventricular pacing devices is expensive.

  Open heart surgical procedures intended to correct mitral valve leakage include, in particular, replacement valve implantation. Valves from animals (eg, pigs) can be used to replace mitral valve 116 in humans. Although the use of porcine valves can replace mitral valves relatively successfully, such valves are generally exhausted, thereby requiring further open surgery at a later date. A mechanical valve that is unlikely to wear out can also be used to replace a leaky mitral valve. However, when a mechanical valve is implanted, the risk of thromboembolism increases and patients generally need to receive extended anticoagulation therapy.

  Less invasive surgical procedures include cardiac bypass surgery associated with port access procedures. For port access procedures, the heart can be accessed by cutting a few ribs as opposed to opening the entire patient's chest. In other words, rather than opening the patient's sternum, a few ribs can be cut with a port access procedure.

  One open heart surgical procedure that has been particularly successful in correcting mitral valve leakage and mitral regurgitation is an annuloplasty procedure. During the annuloplasty procedure, an annuloplasty ring may be implanted into the mitral valve so that the size of the stretched mitral valve 116 is reduced to a relatively normal size. FIG. 3 is a schematic illustration of an annuloplasty ring. The annuloplasty ring 304 is shaped like a generally normal mitral valve profile. That is, the annuloplasty ring 304 is shaped substantially like the letter “D”. Typically, the annuloplasty ring 304 may be formed from a rod or tube of biocompatible material (eg, plastic) (which has a DACRON mesh covering).

  To implant the annuloplasty ring 304, the surgeon surgically attaches the annuloplasty ring 304 to the mitral valve on the atrial side of the mitral valve. Conventional methods for introducing the ring 304 require open heart surgery that involves opening the patient's sternum and installing a cardiac bypass machine in the patient. As shown in FIG. 4, the annuloplasty 304 is stitched to the posterior leaflet 318 and anterior leaflet 320 of the apex portion of the mitral valve 316. In suturing the annuloplasty ring 304 over the mitral valve 316, the surgeon typically uses a needle and thread to remove a relatively large amount of tissue (eg, 1/8 inch of tissue). Byte), and then alternately obtain smaller bits from the valve forming ring 304. Once the thread loosely connects the annuloplasty ring 304 and the mitral valve tissue, the annuloplasty 304 slides over the mitral valve 316, resulting in previously stretched tissue (due to the deposited heart). Are efficiently pulled using, for example, the annuloplasty ring 304 and the tension applied by the thread that joins the annuloplasty ring 304 to the mitral valve tissue. As a result, the gap between the anterior leaflet 320 and the posterior leaflet 318 (eg, the gap 220 in FIG. 2b) can be substantially closed. After the mitral valve is shaped by the ring 304, the anterior leaflet 320 and the posterior leaflet 318 are reshaped to create a new contact line, and the mitral valve 318 is a normal mitral valve. Makes it possible to function like that.

  Once implanted, the tissue generally grows beyond the annuloplasty ring 304 and the contact line between the annuloplasty ring 304 and the mitral valve 16 is essentially normal to the mitral valve 316. It looks like a mitral valve and allows it to function that way. A patient containing an annuloplasty ring 304 can be subjected to anticoagulant therapy, but is only subject to treatment for approximately a few weeks (eg, until tissue has grown beyond the annuloplasty ring 304). So treatment is not massive.

  A second surgical procedure that is generally effective in reducing mitral valve leakage involves placing a single edge-to-edge suture in the mitral valve. With reference to FIG. 5a, such a surgical procedure (eg, Alfieri stitch procedure or bowtie repair procedure) will be described. Edge-to-edge stitch 404 is used to stitch the regions together approximately at the center of gap 408 defined between anterior leaflet 420 and posterior leaflet 418 of mitral valve 416. Once the stitch 404 is made in place, the stitch 404 is pulled to form a suture that holds the anterior leaflet 420 against the posterior leaflet 418, as shown. By reducing the size of the gap 408, the amount of leakage through the mitral valve 416 can be substantially reduced.

  While the edge-to-edge stitch 404 placement generally succeeds in reducing the amount of mitral valve leakage through the gap 408, the edge-to-edge stitch 404 is conventionally known as an open heart. Made through surgery. Furthermore, the use of edge-to-edge stitches 404 is generally not appropriate for patients with a stacked and expanded heart. This is because blood pressure can cause the heart to expand outwardly and exert a relatively large amount of stress on the edge-to-edge stitch 404. For example, a blood pressure of about 120/80 or higher is typically sufficient for the edge-to-edge stitches 404 to expand the heart outward to the extent that it breaks or tears the mitral valve tissue. .

  Another surgical procedure that reduces mitral valve leakage involves placing a suture along the mitral valve ring around the posterior leaflet. A surgical procedure for placing a suture along the mitral valve is described with respect to FIG. The suture 504 is formed along the annulus 540 of the mitral valve 516 around the posterior leaflet 518 of the mitral valve 516 and as a double track (eg, in two “rows”) from a single strand of suture material. ) Can be formed. The suture 504 is ligated at a point 506 approximately in the center of the posterior leaflet 518. The cotton ball 546 is often positioned under the selected suture 504 (eg, at the central point 506) to prevent the suture 504 from tearing through the ring 540. When the suture 504 is ligated, the ring 540 can be effectively tightened to the desired size, so that the size of the gap 508 between the posterior leaflet 518 and the anterior leaflet 520 can be reduced.

  In addition to tightening the suture 504, the placement of the suture 504 along the annulus 540 generally succeeds in reducing mitral valve leakage. However, the placement of structure 504 is conventionally accomplished via an open heart surgical procedure. That is, as with other conventional procedures, the suture-based annuloplasty procedure is invasive.

  While invasive surgical procedures have proven effective in the treatment of mitral valve leakage, invasive surgical procedures often have significant drawbacks. Whenever a patient undergoes open heart surgery, there is a risk of infection. Cutting the sternum and using a cardiopulmonary bypass machine has also been shown to produce significant occurrences of both short-term and long-term neurological deficits. In addition, given the complexity of open heart surgery and the associated significant recovery time, people who are not extremely crippled by CHF syndrome (eg, those in the Class 1 category) choose not to undergo corrective surgery Can be done. In addition, people most in need of open heart surgery (eg, those in the Class 4 category) cannot be operated on either because they are too thin or too weak. Thus, many people who can be improved with a mitral valve that has been surgically repaired cannot undergo surgery.

  Therefore, what is needed is a minimally invasive procedure for mitral valve leakage. In particular, what is desired is a method of reducing leakage between the mitral anterior and posterior leaflets that does not require conventional surgical invasion.

(Summary of the Invention)
The present invention relates to a non-invasive method for performing annuloplasty. In accordance with one aspect of the present invention, a method for performing annuloplasty includes accessing a left ventricle of the heart and providing a discrete pleat formation element to the left ventricle, and the pleat formation element. Engaging the tissue near the mitral valve of the heart. Engaging the pleating element includes gathering a portion of the tissue to create the pleat. In one embodiment, accessing the left ventricle of the heart to provide a plication element includes accessing the left ventricle of the heart using a catheter placement.

  In another embodiment, engaging the plication element with tissue near the mitral valve includes puncturing the tissue using the plication element, whereby the plication element's first step. One portion is positioned on the atrial side of the mitral valve and the second portion of the plication element is positioned on the ventricular side of the mitral valve. In such an embodiment, the delivery catheter may be positioned such that the first portion of the plication element is positioned on the atrial side of the mitral valve.

  Performing an annuloplasty on the mitral valve, for example using a catheter to access the left ventricle of the heart, avoids complex surgical procedures when treating mitral valve leakage. enable. By avoiding open heart surgical procedures, patients who can generally be improved by annuloplasty become more accessible to annuloplasty. Because mitral valve leakage is often considered an early sign of congestive heart failure, a minimally invasive annuloplasty procedure that corrects the leakage problem (eg, a procedure involving positioning separate plications in the fibrous tissue around the mitral valve) ) Can greatly improve the quality of life of many patients who may not be suitable for invasive annuloplasty procedures.

  In accordance with another aspect of the present invention, a method for performing annuloplasty includes a step of accessing tissue located near a mitral valve of a heart and a first in tissue using a first plication element. Creating a separate pleat formation. This first separate pleat formation causes the mitral valve arc length to be reduced by effectively reducing the size of the ring around the mitral valve. In one embodiment, accessing the tissue includes accessing the tissue through the left ventricle of the heart using a catheter. In such embodiments, the first plication element can be provided via a catheter.

  In other embodiments, the first pleating element can be an element including a clip element, a locking element or bar portion, a thread and a lock. The thread can generally be a tension element, a flexible tension element, or a suture. Creating a first discrete pleat formation in the tissue using the clip element includes engaging the tissue using the clip element. If the first pleat forming element is a locking element (eg, a locking element comprising two parts), the step of creating the first separate pleat formation may comprise a portion of the first part and a part of the second part. Using a portion to penetrate the tissue and engaging the tissue between the first and second portions. Alternatively, if the first pleat forming element includes a bar portion, a thread and a lock, creating the first separate pleat formation includes penetrating the tissue to position the bar portion on the atrial side of the tissue. Piercing the thread to position the bar portion relative to the atrial side of the tissue, and against the ventricular side of the tissue to create a first separate pleat between the bar portion and the lock. Locking the lock.

  In accordance with yet another aspect of the present invention, a system suitable for use in an annuloplasty procedure comprises a catheter assembly and a bendable member. The catheter assembly is positioned for insertion from the aorta of the heart into the left ventricle of the heart, reaching the left ventricular region substantially below the mitral valve, and the bendable member is left through the catheter assembly. Moveable between a first position and a second position for insertion into the ventricle. The bendable member is also positioned to create a fold in the tissue near the mitral valve when in the second position.

  In accordance with yet another aspect of the present invention, a system suitable for use in an annuloplasty procedure comprises a catheter assembly and a suture structure. The catheter assembly is positioned for insertion from the heart aorta to the left ventricle of the heart and reaches the region of the left ventricle substantially below the mitral valve. The suturing structure comprises a first bar member, a second bar member, a thread and a locking element that moves or slides over the thread. The catheter assembly is further configured so that the first bar member and the second bar member penetrate tissue near the mitral valve and the locking element contacts tissue on the ventricular side of the mitral valve. It is arranged to move beyond the yarn. The pleat formation is made essentially of tissue between the first bar member, the second bar member and the locking element.

  In accordance with another aspect of the present invention, a system for performing annuloplasty on a mitral valve of a heart includes a catheter assembly, a guide element, and a plication element. The catheter assembly is positioned for insertion into the left ventricle of the heart through the aorta of the heart and reaches the region of the left ventricle substantially below the mitral valve. The guide element is shaped for insertion into the catheter assembly, and the plication element is beyond the guide element using the catheter assembly, substantially for insertion into the left ventricle under the mitral valve Formed. The plication elements are arranged to collect heart tissue and create plications in the tissue.

  These and other advantages of the present invention will be understood by reading the following detailed description and studying the various figures of the drawings.

  The invention may best be understood by referring to the following description in conjunction with the accompanying drawings.

(Detailed description of embodiment)
Invasive open heart surgery is generally effective in the treatment of mitral valve leakage. However, open heart surgery can be particularly harmful to some patients (eg, fragile patients that are considered very unhealthy) and other patients (eg, asymptomatic patients and surgical procedures). May not be desirable for patients who do not want to perform Thus, open heart surgery to correct mitral valve leakage or more common mitral valve failure would potentially be improved by reducing or eliminating mitral valve leakage Not suitable for many patients.

  A catheter-based annuloplasty procedure can perform annuloplasty in a patient without requiring the patient to undergo open-heart surgery or a cardiopulmonary bypass. The catheter can be inserted through the aorta and into the left ventricle of the heart to position the guidewire and plication implants on the ventricular side of the mitral valve (ie, below the mitral valve). A catheter may also be used to connect the plication implant to the fibrous tissue associated with the heart skeleton around the mitral valve.

  The use of a catheter to perform an annuloplasty procedure by delivering and engaging a pleat insert or plication structure is not involved in an angiotomy and without a bypass procedure. Allows to be executed. The recovery time associated with annuloplasty and the risks associated with annuloplasty can be substantially minimized when the annuloplasty is catheter based. As a result, ring formation is a more accessible procedure. This is because many patients (e.g., weak and asymptomatic patients) who have not previously been treated for mitral valve leakage may choose to perform a catheter-based annuloplasty.

  To begin the catheter-based annuloplasty procedure, the delivery tube and J-shaped catheter can be inserted through the aorta and into the left ventricle of the heart. Insertion of a delivery tube and J-shaped catheter through the aorta allows the left ventricle of the heart to be substantially reached into the left ventricle without contact with the palisade or chordae tendonae . FIG. 6a is a schematic illustration of a schematic delivery tube and J-shaped catheter according to an embodiment of the present invention. Delivery tube 604 has a substantially annular cross-section and is configured to receive a J-shaped catheter 608. If necessary, the J-shaped catheter 608 is arranged and opened in the delivery tube 604 for longitudinal movement through the delivery tube 604.

  In general, delivery tube 604 is an elongated body that is flexible, durable, and biocompatible, eg, nylon, urethane, or a blend of nylon and urethane (eg, PEBAX®). ). Similarly, the J-shaped catheter 608 (which is also an elongated body) can also be formed from a biocompatible material. The material used to form the J-shaped catheter 608 is also typically relatively flexible. In the described embodiment, the top of the J-shaped catheter 608 is sufficient to allow the distal end of the J-shaped catheter 608 to maintain a relatively curved shape (eg, a “J” shape). It is a rigid body. As described below with respect to FIGS. 7a-7c, the curvature of the J-shaped catheter 608 is configured to facilitate positioning of the groove catheter.

  FIG. 6b is a schematic illustration of a delivery tube 604 and a J-shaped catheter 608 positioned within the heart according to an embodiment of the present invention. As shown, after delivery tube 604 and J-shaped catheter 608 are effectively “meandered” or inserted through the femoral artery, delivery tube 604 and J-shaped catheter 608 are positioned at aorta 620 of heart 616. Positioned within. The tip 626 of the J-shaped catheter 608 (which is oriented substantially perpendicularly from the body of the J-shaped catheter 608) and the end of the delivery tube 604 are oriented so that they pass through the aortic valve 630. Is done. Accordingly, the end and tip 626 of the delivery tube 604 are positioned at the top of the left ventricle 624, where the wall 632 of the left ventricle 624 is relatively smooth. The relatively smooth top of the left ventricle 624 allows the catheter to be properly positioned within the left ventricle 624 by guiding the tip of the catheter along the wall 632. In one embodiment, the tip 626 is oriented such that it is positioned on the ventricular side of the mitral valve 628 and approximately just below the mitral valve 628.

  Once positioned within the left ventricle 624, the J-shaped catheter 608 can be rotated within the delivery tube 604 so that the tip 626 follows the contour of the wall 632 with the groove catheter delivered therethrough. Can make it possible. Typically, the groove catheter is an area that is effectively defined between the plane for papillary muscle 640, the plane for the posterior leaflet of mitral valve 628, chordae 642, and wall 632, along the contour of wall 632. Extend. The “groove” is located in such an area or region, and more specifically, substantially lower right of the mitral valve 628 where there is a relatively small amount of trabeculae. Located in.

  With reference to FIGS. 7a-7c, a groove catheter is described in accordance with an embodiment of the present invention. Groove catheter 704 (which is part of catheter assembly 702, as shown in FIG. 7a) is positioned to extend through J-shaped catheter 626 so that groove catheter 704 is mitral. It can be advanced into the left ventricle just below the valve. Groove catheter 704, which may include a balloon tip (not shown), is typically formed from a flexible material, such as nylon, urethane, or PEBAX®. In one embodiment, the steerable groove catheter 740 can be formed using shape memory metal.

  As shown in FIGS. 7a and 7b (which represent a cross section of the catheter assembly 702 taken at position 710), the groove catheter 704 is positioned at least partially within the J-shaped catheter 608, and The J-shaped catheter is then at least partially positioned within the delivery tube 604. Groove catheter 704 can freely rotate within J-shaped catheter 608 and can extend through J-shaped catheter 608, while J-shaped catheter 608 can rotate freely within delivery tube 604. And can extend through the delivery tube 604.

  Referring now to FIG. 7c, positioning of the groove catheter 704 within the left ventricle of the heart will be described in accordance with an embodiment of the present invention. It should be understood that the representation of the sulcus catheter 704 within the left ventricle 720 is not drawn to scale for simplicity of explanation and discussion. For example, the distance between the wall 724 of the left ventricle 720 and the mitral valve 728 is exaggerated. Furthermore, it should also be understood that the positioning of the delivery tube 604 within the aortic valve 732 and thus the positioning of the J-shaped catheter 608 and the groove catheter 704 can vary.

  Groove catheter 704 protrudes through tip 626 of J-shaped catheter 608 and is steered along the contour of wall 724 of left ventricle 720 just below mitral valve 728 (ie, into the groove of left ventricle 720). Along) substantially forming an arc shape similar to the arc shape of the mitral valve 728. The wall 724 of the left ventricle 720 is relatively smooth (ie, generally does not include trabeculae) just below the mitral valve 728. Thus, by inserting the catheter assembly 702 through the aortic valve 732 and into the upper portion of the left ventricle 720, the groove catheter 704 is substantially occluded by the trabeculae or chordae and mitral valve 720 along the wall 724. Can be guided within.

  Groove catheter 704 generally includes an opening or lumen (not shown) that is sized to receive a guide wire through which the guide wire can be inserted. This opening may be located along the central axis of the groove catheter 704 (ie, the central axis 730 as shown in FIG. 7a). Delivery of the guidewire through the groove catheter 704 allows the guidewire to effectively follow the contour of the wall 724. In general, the guide wire includes an anchoring tip that allows the guide wire to be substantially anchored to the wall 724. FIG. 8 is a schematic cut-away top view of the left side of the heart with a guidewire positioned in accordance with an embodiment of the present invention. For ease of discussion, it should be understood that the representation of the left side of the heart in FIG. 8 is not drawn to scale and that various features are exaggerated. Guidewire 802 is positioned along wall 724 of left ventricle 720. Once the guide wire 802 is inserted through the groove catheter 704 of FIGS. 7a-7c and anchored to the wall 724 using the anchor tip 806, the groove catheter 704, along with the J-shaped catheter 708, is removed from the patient's body. Pulled out. It should be understood that after guidewire 802 is anchored to wall 724, delivery tube 604 typically remains positioned within the aorta.

  A guide wire 802 (which can be formed from a material such as stainless steel or shape memory material) is generally anchored so that the guide wire 802 effectively passes along most of the wall 724. Typically, the guide wire 802 acts as a track over which the catheter carrying the plication structure can be positioned (ie, the lumen of the catheter delivering the plication element over the guide wire 802). Get through). Such a catheter may comprise a balloon structure (not shown) or an inflatable structure, which is substantially localized by pressing the local plication structure against the fibrous tissue surrounding the mitral valve. Positioning of the pleat forming structure can be facilitated.

  By forming a local pleat, a bundle of fibrous tissue around the mitral valve is captured or collected, thereby reducing dilation of the mitral valve posterior leaflet. In general, a local pleat is a discontinuous fold that is formed in the fibrous tissue around the mitral valve using a suture structure or discontinuous mechanical elements. FIG. 9a is a top-down cutaway representation of the left ventricle of the heart, where a local plication suture structure has been implanted in accordance with an embodiment of the present invention. The suture structure (which comprises a T-shaped bar 904 and thread 907) is implanted into tissue near the mitral valve 916 (eg, the annulus of the mitral valve 916). Typically, the tissue into which the suture structure is implanted is fibrous tissue 940 located substantially around the mitral valve 916. Suitable suturing structures include structures comprising a T-shaped bar 904 and a thread 907, as described below with reference to FIGS. 10a, 10b, 11, and 12a-c. It is not limited.

  The T-bar 904 or similar structure, when implanted, cuts through the tissue 940 so that the surgical swab 905 strikes the ventricular side tissue 940 and effectively “ "Protect". Accordingly, a portion of the T-shaped bar 904 is positioned over the mitral valve 916 (ie, the arterial side of the mitral valve 916), while the surgical swab 905 is positioned on the ventricular side of the mitral valve 916. Is positioned. It should be understood that additional or alternative cotton removal can be positioned on the arterial side of the mitral valve 916, substantially between the tissue 940 and the T-shaped bar 904. A catheter that delivers a suture structure 904 from the ventricular side of the mitral valve 916 to the arterial side of the mitral valve 916 is discussed below with respect to FIGS.

  In the described embodiment, the T-shaped bars 904 are joined such that two T-shaped bars (eg, T-shaped bars 904a) are joined by a thread (eg, thread 907a). The thread 907a is configured such that the T-bar 904a can be tensioned together and secured to the tissue 940. By securing the T-shaped bar 904a, the tissue 940 can be bundled or slightly collected, thereby reducing the length of the arc relative to the tissue 940, thereby reducing the size of the mitral valve 916 (eg, Effectively limit the arc length). In other words, the presence of the T-shaped bar 904 that cooperates with the thread 907 and substantially functions as a suture reduces and further increases the gap 908 between the anterior leaflet 920 and the posterior leaflet 918. Making it possible to be substantially prevented. As will be appreciated by those skilled in the art, over time, scar tissue (not shown) may form around surgical swab 905 and T-bar 904.

  In general, the number of T-bars 904 used to locally bundle or collect tissue 940 can vary widely. For example, if a substantially tiny local reflux jet occurs at the mitral valve 916, only a few T-bars 904 can be implanted proximal to the reflux jet. Alternatively, if the size of the gap 908 is significant and there is a relatively large amount of mitral valve leakage, a relatively large number of T-shaped bars 904 and thus surgical swabs 905 are used and the mitral valve By reducing the arc length of 916, the size of the gap 908 can be reduced. Some surgical swabs 905 can be arranged to at least partially overlap. In order to correct a counter-current jet concentrated on only one part of the mitral valve 916, the T-bar 904 is as a pleating element near the counter-flow jet and as a reinforcement element away from the counter-flow jet (eg, substantially In order to prevent the progression of mitral valve disease from causing the final gap to be formed).

  Although it has been described that two T-bars 904a are joined by a thread 907a, it should be understood that the number of T-bars 904 joined by the thread 907 can vary. For example, if multiple T-bars 904 are joined by multiple threads 907, it may be possible to collect more fibrous tissue with a smaller total number of T-bars 904. With reference to FIG. 9b, a plurality of T-shaped bars 904 connected by a plurality of threads 907 are described. T-shaped bar 904c is coupled by thread 907c, while T-shaped bar 904d is coupled by thread 907d. Similarly, the T-shaped bar 904e is joined by a thread 907e. T-shaped bar 904d 'is further coupled to T-shaped bar 904c "by thread 907f, and T-shaped bar 904d" is also coupled to T-shaped bar 904e' by thread 907g. As discussed below, the thread 907 allows the T-shaped bar 904 to be pulled against the surgical swab 905 and thus the tissue 940. By joining T-bars 904 in this manner, folds in tissue 940 are created between T-bars 904c, T-bars 904d, and T-bars 904e, while the tissue is At least some collection can be achieved between the T-shaped bar 904c ″ and the T-shaped bar 904d ′ and between the T-shaped bar 904d ″ and the T-shaped bar 904e ′.

  In general, the configuration of the suturing structure comprising the T-shaped bar 904 and the thread 907 can vary. One embodiment of a suitable suturing structure is shown in FIGS. 10a and 10b. 10a and 10b are representations of the suture structure after a T-bar has been introduced to the arterial side of the fibrous tissue near the mitral valve, according to an embodiment of the present invention. It should be understood that for purposes of explanation, the elements and structures shown in FIGS. 10a and 10b and substantially all other figures are not drawn to scale. The suturing structure 1000 includes a T-shaped bar 904 (ie, a reinforcement element) coupled to the thread 907 so that when the thread 907 is pulled, the T-shaped bar 904 is effectively pressed against the tissue 940. . By pulling the thread 907 and pushing the locking element 1002, as shown in FIG. 10b, the locking element 1002 contacts the ventricular side of the tissue 940 and the T-bar 904 is effective against the tissue 940. Hold on. Specifically, by pulling the loop 1004 of the thread 907 and simultaneously pushing the locking element 1002, the T-shaped bar 904 is clamped against the tissue 940 so that the locking element 1002 is secured in place and the T-shaped. A pleat 1006 may be formed in the tissue 940 when the bar 904 is secured in place.

  Surgical swab 905 can serve as a pleat anchor for T-bar 904 (which essentially functions as a suture), as will be appreciated by those skilled in the art. That is, surgical swab 905 can prevent T-bar 904 from cutting through tissue 940. In general, the configuration of surgical swab 905 can vary widely. For example, surgical swab 905 can have a substantially tubular shape and can be formed from a material such as a surgical mesh (eg, Dacron mesh). However, it should be understood that the surgical swab 905 can be formed in substantially any shape and from virtually any material that promotes or supports the growth of scar tissue therethrough. is there. Suitable materials include, but are not limited to, silk and virtually any biocompatible porous or fibrous material.

  The locking element 1002 can be a one-way locking element (eg, an element that cannot be easily released once fixed) formed from a biocompatible polymer. The configuration of the locking element 1002 can vary widely. An alternative configuration of the locking element 1002 is described below with reference to FIGS. 11 and 12a-c. In order to engage the locking element 1002 to the surgical swab 905, a catheter used to deliver the T-bar 904 may be used to push the locking element 1002 into a fixed position. A catheter that can deliver a T-bar 904 and also engage a locking element 1002 is discussed below with reference to FIGS.

  Similar to locking element 1002, T-shaped bar 904 may also be formed from a biocompatible polymer. Thread 907 (which can join T-bar 904 by tying T-bar 904 to thread 907 or molding T-bar 904 onto thread 907) is a suture It can be formed from virtually any material typically used to form. Suitable materials include, but are not limited to, silk, prolene, braided Dacron, and polytetrafluoroethylene (PTFE, or GoreTex).

  As described above, the configuration of the locking element 1002 can vary. For example, the locking element may comprise a spring element as shown in FIG. The suturing structure 1100 includes a T-shaped bar 1104, a thread 1107, and a locking element 1102. For ease of explanation, the elements of the suture structure 1100 are not drawn to scale. Although the suture structure 1100 is not shown as comprising surgical cotton removal, the suture structure 1100 may comprise surgical cotton removal, which are reinforcements that generally support the growth of scar tissue. It should be understood that it works as an element.

  The locking element 1102 includes a solid element 1102a and a spring element 1102b. The solid element 1102a can be formed from a biocompatible polymer, but the solid element 1102a can also be formed from a material typically used to form surgical swabs. The spring element 1102b is arranged to be held in the extended position, as shown, while the loop 1114 of the thread 1107 is being pulled. Once the T-shaped bar 1104 is in contact with the tissue 1140, the solid element 1102a can be in contact with the tissue 1140 and the spring element 1102b can contract to create a spring force, which spring force causes the solid element 1102a to Pull towards each other. In other words, once the T-bar 1104 is properly positioned with respect to the tissue 1140, the locking element 1102 can be secured to form a fold or local bundle of tissue 1140.

  In one embodiment, the formation of scar tissue in the fibrous tissue proximal to the mitral valve can be promoted before plication is formed or before the fibrous tissue is collected to compensate for mitral valve failure. . With reference to FIGS. 12a-c, a locking element that promotes the growth of scar tissue prior to plication is described in accordance with an embodiment of the present invention. As shown in FIG. 12 a, the suturing structure 1200 (which is not drawn to scale) includes a locking element 1204, a thread 1207, and a T-shaped bar 1204. A locking element 1204 (comprising a solid element 1202a, a spring element 1202b, and a resorbable polymer overmold 1202c formed on the spring element 1202b) is formed on the ventricular side of the tissue 1240 on the ventricular side. 1207.

  Overmold 1202c (which can be formed from a resorbable lactide polymer (eg, PURASORB available from PURAC America, Lincolnshire, Illinois) over spring element 1202b while spring element 1202b is in the extended position. The overmold 1202c is arranged to remain intact while the scar tissue 1250 is formed over the solid element 1202a.In one embodiment, facilitates the formation of scar tissue. Thus, the solid element 1202a may be formed from a porous or fibrous material (eg, “surgical swab material”).

  Once scar tissue is formed on solid element 1202a, overmold 1202c is broken (eg, disassembled), exposing spring element 1202b, as shown in FIG. 12b. As will be appreciated by those skilled in the art, the chemical composition of the overmold 1202c can be controlled such that the amount of time that elapses before the overmold 1202c breaks (eg, a desired amount of scar tissue is formed). To be decomposed after being predicted). Thus, once the overmold 1202c is broken and the spring element 1202b is contacted as shown in FIG. 12c, sufficient scar tissue 1250 is generally formed on the solid element 1202a to form a solid The element 1202a is effectively coupled to the tissue 1240, making it possible to form a relatively strong fold or gather of the tissue 1240.

  The loop 1214 of the thread 1207 can be left extending into the left ventricle of the heart, but the thread 1207 is cut (ie, the loop 1214 is effectively removed) and the amount of thread 1207 that sags in the heart. Can be reduced. Alternatively, the sagging thread 1207 can be effectively eliminated by collecting the thread 1207 around a cylindrical arrangement (not shown) located on the locking element 1202. That is, a spool or similar element may be included as part of the suture structure 1200 to allow either the slack thread 1207 to be collected within the spool or collected around the outside of the spool. .

  By using the overmold 1202c, the anchoring force that holds the T-bar 1204 and the locking element 1202 in place can be relatively low. This is because there is substantially no significant force acting on the tissue 1240 until scar tissue or tissue ingrowth is created. Once scar tissue is created and the overmold 1202c disassembles, the spring 1202b compresses. The mooring force generated at this point can be relatively high. However, since scar tissue has been formed, the likelihood that the T-bar 1204 will cut into the tissue 1240 at this point is generally relatively low.

  As described above, a catheter can be used to deliver the suture structure to the heart and to engage the suture structure around the mitral valve of the heart. One embodiment of a suture structure delivery catheter suitable for use in catheter-based annuloplasty using local plication is described with respect to FIG. 13a. The delivery catheter 1300 can be positioned over a guide wire (eg, guide wire 802 as shown in FIG. 8), which guide wire allows the delivery catheter 1300 to be delivered to the heart groove. Work as. It should be understood that the elements of delivery catheter 1302 are not drawn to scale. Within delivery catheter 1300 is a wire 1308 that carries a T-bar 1304 of the suture structure. In one embodiment, the T-shaped bar 1300 is coupled to the thread 1307 and the locking element 1300 to form a suture structure. Typically, the sharp or sharp end 1311 of the wire 1308 is configured to puncture tissue (not shown) (eg, cardiac fibrous tissue near the mitral valve). Once end 1311 and T-shaped bar 1304 are positioned over the fibrous tissue (eg, the arterial side of the mitral valve), wire 1308 can be retracted and repositioned. After the wire 1308 is repositioned, the end 1311 can again puncture the tissue, effectively placing the T-bar 1304 over the tissue on the arterial side of the mitral valve.

  The wire 1308, or more specifically, the end 1311 can be used to pull the thread 1307 and push the locking element 1302 into place in place relative to the tissue near the mitral valve. As an example, the end 1311 may pull the thread 1307 until the T-shaped bar 1304 contacts the tissue. The end 1311 can then be used to secure the locking element 1302 to the tissue, thereby creating a pleat in the tissue and effectively contracting the mitral valve annulus.

  To create additional pleats, the wire 1308, and in one embodiment, the delivery catheter 1300 may be fully withdrawn from the patient to allow additional T-bars to be loaded onto the wire 1308. Once an additional T-shaped bar is positioned on the wire 1308, the wire 1308 can be reinserted into the delivery catheter 1300, and the delivery catheter 1300 is located near the mitral valve, another fold. Can be used to allow it to be formed into tissue.

  FIG. 13b is a representation of a second catheter suitable for delivering a suture structure according to an embodiment of the present invention. Catheter 1340 (which is not drawn to scale and may include a lumen (not shown) arranged to be inserted over the guide wire) includes two wires 1348, which Are arranged to cooperate to carry the suture structure. As shown, wire 1348a carries a T-shaped bar 1344a, while wire 1348b carries a T-shaped bar 1344b, which are joined by a thread 1347 and with a locking element 1342. Together, they form a suture structure. The tip 1351 of the wire 1348 passes through tissue near the mitral valve and places a T-bar 1344 over the mitral valve. Once the T-shaped bar 1344 is deployed, the tip 1351 is used to pull the T-shaped bar 1344 against the tissue and to secure the locking element 1342 against the opposite side of the tissue. obtain. As an example, the tip 1351b can be configured to pull the thread 1347 while the tip 1351a presses against the locking element 1342.

  Referring to FIG. 13c, a catheter arrangement that can deploy a T-bar from its tip is described in accordance with an embodiment of the present invention. Catheter arrangement 1360 comprises two catheters, each of which carries a T-shaped bar 1364. It should be understood that the elements of FIG. 13c are not drawn to scale for ease of explanation. Specifically, the catheter 1360a carries a T-shaped bar 1364a at its tip, while the catheter 1360b carries a T-shaped bar 1364b at its tip. A thread 1367 couples the T-bar 1364 together so that the locking element 1362 (through which the thread 1367 passes) substantially secures the T-bar 1364 to the heart tissue. obtain.

  In one embodiment, the catheter arrangement 1360 may require the use of two guide wires to guide each of the catheters 1360a and 1360b into the heart groove. Alternatively, catheter 1360a and catheter 1360b can be positioned such that both catheter 1360a and catheter 1360b can be guided through the heart groove by use of a single guidewire.

  Catheter 1360a pushes T-bar 1364a through the tissue near the mitral valve of the heart and releases T-bar 1364a once T-bar 1364a is placed on the ventricular side of the mitral valve. Configured as follows. Similarly, catheter 1360b is configured to push T-bar 1364b through tissue and release T-bar 1364b. The T-bar 1364 can be separated, for example, when heat is applied to the dielectric material associated with the catheter 1360, thereby effectively detaching the T-bar 1364. Alternatively, a mechanical mechanism (not shown) that engages the T-bar 1364 with the catheter 1360 can be disengaged to release the T-bar 1354. Once the T-shaped bar 1364 is positioned on the ventricular side of the mitral valve, the catheter 1360 can be used to pull the thread 1367 and push the locking element 1362.

  With reference to FIGS. 14a and 14b, performing an annuloplasty procedure using a catheter-based system for implanting a suture structure in tissue near a mitral valve will be described in accordance with an embodiment of the present invention. Once the patient is prepared (eg, sedated), the annuloplasty procedure 1400 may begin by inserting a delivery tube and a J-shaped catheter into the left ventricle of the patient's heart. These delivery tubes and J-shaped catheters can be inserted through the femoral artery into the patient's body and through the femoral artery and aorta and into the left ventricle of the heart. In general, a J-shaped catheter is positioned within a delivery tube. One embodiment of a delivery tube and a J-shaped catheter has been described above with respect to FIGS. 6a and 6b. As will be appreciated by those skilled in the art, the delivery tube and the J-shaped catheter typically each reach the left ventricle through the aortic valve.

  Once the delivery tube and the J-shaped catheter are positioned in the left ventricle, in step 1408, the groove catheter can be extended through the J-shaped catheter. As discussed above with respect to FIGS. 7a-c, the groove catheter is positioned to effectively extend relative to the groove in the wall of the left ventricle substantially immediately below the mitral valve. Specifically, the sulcus catheter may be positioned in the left ventricular space between the mitral valve and the papillary muscle (or papillary muscles). Groove catheters often have a flexible steerable tip. In one embodiment, the tip of the groove catheter can be coupled to an inflatable balloon. The J-shaped catheter, among other purposes, serves to allow the groove catheter to be initially oriented in the proper direction so that the groove catheter can be positioned along the left ventricular wall. .

  In step 1412, a guidewire comprising an anchoring device can be delivered through a gutta catheter (eg, through the lumen or opening of the grooving catheter). The guide wire is delivered through the grooved catheter so as to follow the groove wire profile relative to the left ventricular wall. After the guidewire is delivered, the guidewire anchoring device is anchored to the left ventricular wall at step 1416. Anchoring the guide wire against the left ventricular wall or otherwise implanting the guide wire allows the guide wire to be maintained in that position within the left ventricle.

  The J-shaped catheter and the sulcus catheter are withdrawn from the left ventricle through the femoral artery in step 1420, with the guidewire anchored to the left ventricle, as described above with respect to FIG. Next, at step 1436, a T-bar assembly delivery catheter carrying a T-bar assembly is inserted through the femoral artery and into the left ventricle over the guidewire. In one embodiment, the T-bar assembly delivery catheter carries an uninflated balloon.

  After the T-bar assembly delivery catheter is inserted into the left ventricle, the balloon is inflated at step 1428. The balloon (eg, an elastomeric balloon) is inflated at a relatively moderate pressure using, for example, an air source coupled to the balloon through a T-bar assembly delivery catheter, thereby using the guidewire as a track. Virtually any catheter acts to allow the fibrous tissue surrounding the mitral valve to be pushed up. In general, the inflated balloon substantially occupies the space between the mitral valve and the papillary muscle. In one embodiment, more than one balloon can be inflated in the left ventricle.

  Once in step 1428, the balloon is inflated. The T-bar assembly delivery catheter attaches to a T-bar or similar mechanism, surgical pledget, and mitral valve annulus (eg, fibrous tissue of bone around the mitral valve) Otherwise, it is effectively delivered to the thread that is adapted to be coupled to it and the pleats are made. A suitable catheter has been described above with respect to FIGS. In step 1440, pleats are created using a T-bar assembly in virtually any suitable tissue near the mitral valve. For example, the pleats can be made by essentially pushing the T-bar through the tissue and then securing the T-bar to the tissue using the securing mechanism of the T-bar assembly. Specifically, tissue plication or bunching extends a pointed wire carrying an element such as a T-shaped bar through the tissue, then retracts the pointed wire and T It can be made by placing the letter bar in place. By arranging the T-shaped bar and fixing the fixing mechanism, the tissue between the T-shaped bar and the fixing mechanism can be linked together.

  Once the pleat is created at step 1440, the balloon is typically deflated at step 1442. The T-bar assembly delivery catheter can then be removed through the femoral artery at step 1444. A determination as to whether additional pleats are made is made at step 1448 after the T-bar assembly delivery catheter has been removed. If it is determined that additional pleats will be created, then process flow returns to step 1436 and the T-bar assembly delivery catheter carrying the T-bar assembly or suture structure is reinserted into the femoral artery. Is done.

  Alternatively, if it is determined at step 1448 that no further pleats are created, then process flow may proceed to step 1456 where the guidewire may be removed. After the guidewire is removed, the delivery tube may be removed at step 1460. Once the delivery tube is removed, the annuloplasty procedure is complete.

  Instead of using a suture structure such as a T-bar assembly to create local folds, other elements also create local folds in the fibrous tissue near the mitral valve during the annuloplasty procedure. Can be used to FIG. 15 is a cutaway plan view showing the left side of a heart that has been locally pleated with individual discrete elements in accordance with an embodiment of the present invention. Local plication element 1522 may be used to reduce the size of gap 1508 between anterior leaflet 1520 and posterior leaflet 1518 (eg, to reduce the length of the arc associated with posterior leaflet 1518). It is effectively implanted into the fibrous tissue 1540 around the portion of the cap valve 1516. The local plication element 1522 is arranged to collect pieces of tissue 1540 to create a local pleat. The local pleats created by the local pleat forming element 1522 (which is typically a mechanical element) reduces the size of the mitral valve annulus, and hence the size of the gap 1508. As will be appreciated by those skilled in the art, over time, scar tissue may grow around or on the local pleating element 1522.

  The configuration of the local plication element 1522 can vary widely. For example, the local plication element 1522 can be a metallic element having spring-like characteristics or a deformable metallic element having shape memory characteristics. Alternatively, each local pleat forming element 1522 can be formed from separate pieces that can be physically secured together to form a pleat. With reference to FIGS. 16a-d, one embodiment of a local plication element having spring-like characteristics will be described in accordance with an embodiment of the present invention. The local plication element 1622 can be delivered to the ventricular side or the bottom side of the tissue 1640 located near the mitral valve. When delivered (eg, through a catheter), element 1622 is in a substantially folded and closed orientation, as shown in FIG. 16a. In other words, element 1622 is in a closed configuration that facilitates delivery of element 1622 through the catheter. After an initial compressive force is applied to the corner 1607 of the element 1622, the end or sharp tip 1609 of the element 1622 can be unfolded or opened. If the sharp tip 1609 opens, the end 1606 of the sharp tip 1609 can be pressed against the tissue 1640 as shown in FIG. 16b. The application of compressive force to the sharp tip 1609 and the pushing force on the bottom 1611 of the element 1622 allows the end 1606 (and thus the sharp tip 1609) to grasp the tissue 1640. This is because the tip 1606 pushes through the tissue 1640 as shown in FIG. 16c. Closing the sharp tip 1609 due to the compressive force applied to the sharp tip 1609 causes tissue 1640 to collect between the sharp tips 1609, resulting in the formation of pleats 1630, as shown in FIG. 16d. In one embodiment, a catheter (not shown) that delivers element 1622 may be used to apply force to element 1622.

  As described above, the elements used to create the local folds can be made from a shape memory material. Using a shape memory material to make the pleating element allows the pleating element to self-fix. FIG. 17a is an illustration of one pleating element formed from a shape memory material in accordance with an embodiment of the present invention. Clip 1704 (which can be formed from a shape memory material (ie, an alloy of nickel and titanium)) is in an expanded or open state when introduced into a left ventricular gutter (eg, via a catheter). Arranged to be. Typically, the retaining clip 1704 in the expanded state is involved in applying force to the clip 1704. In one embodiment, the catheter may hold a side 1708 of the clip 1704 to maintain the clip 1704 in an expanded state.

  Once the tip 1706 of the clip 1704 is pushed through the fibrous tissue near the mitral valve of the heart so that the tip 1706 is located on the atrial side of the mitral valve, the force can be removed from the clip 1704. Since the clip 1704 is formed from a shape memory material, once the force is removed, the clip 1704 forms itself into its “rest” state, as shown in FIG. 17b. In its resting or preferred state, clip 1704 is positioned to collect tissue in opening 1712 defined by clip 1704. That is, the initial clip 1704 is in a closed configuration and is effective in stitching tissues to create local folds.

  Another different self-locking plication element suitable for creating a local pleat is a closed or engaged position from the open position once the force applied to hold the clip in the open position is removed. The clip can be twisted toward the mating position. FIG. 18a is an illustration of another self-locking plication element shown in a closed position in accordance with an embodiment of the present invention. Clip element 1800, which may be formed from a material such as stainless steel or shape memory material, once clip element 1800 is positioned in gap 1810 between sharp tip 1806 and sharp tip 1808, is tissue 1830. The tissue 1830 is pre-filled so that it can be returned to the state of plucking in the gap or space 1810.

  Sharp tip 1806 and sharp tip 1808 initially penetrate tissue 1830 (eg, mitral valve annulus tissue). When the sharp tip 1806 and the sharp tip 1808 are pulled together to create a pleat, thereby reducing the size of the gap 1810 by reducing the distance 1820, the bottom portion 1812 of the clip element 1800 is It is effectively twisted by the shape memory characteristics of the clip element 1800 (eg, with 4 weaving). Thus, an effective fixation is obtained that holds the sharp tip 1806 and the sharp tip 1808 in the closed position so that the tissue 1830 is collected to form a local pleat.

  Instead of a pre-filled clip element, the clip element may comprise a locking mechanism that engages when a force is applied. FIG. 18a is an illustration of a self-fixing pleating element with a sliding lock according to an embodiment of the present invention. Clip element 1850 includes a main body 1852 and a slider 1862 arranged to slide over at least a portion of main body 1852. Clip element 1850, which may be formed from a material such as stainless steel or shape memory material, includes a tip 1856 and a tip 1858 that are substantially separated by gap 1852 when slider 1862 is in the unlocked position. As shown, the slider 1862 is in an unfixed position or an open position when the slider 1862 is positioned near the tapered neck 1854 of the body 1852.

  When the clip element 1850 is delivered to the left ventricle (eg, using a catheter), the clip element 1850 is inserted into the left ventricle so that the tip 1856 and tip 1858 effectively penetrate through the fibrous tissue 1880 near the mitral valve. Be placed. After tip 1856 and tip 1858 are positioned substantially on the atrial side of tissue 1880, force may be applied to slider 1862 to move slider 1862 over body 1852 in y-direction 1870b. As the slider moves away from the tapered neck 1854 in the y direction 1870b, the slider 1862 causes the tip 1856 and tip 1858 to close the gap 1860 together (ie, the tip 1856 and tip 1858 are in the x direction relative to each other). To 1870a). When tip 1856 and tip 1858 cooperate to close gap 1860, tissue 1880 is collected within clip element 1850, thereby forming a local fold.

  In one embodiment, slider 1862 may contact tissue 1880 when slider 1862 is in a closed position such that tip 1856 and tip 1858 cooperate to close gap 1856. Thus, in order to promote the growth of scar tissue across a portion of clip element 1850 (or more specifically, slider 1862), at least the upper surface of slider 1862 has a pledget material (eg, the growth of scar tissue therethrough). And a mesh supporting the same.

  The locking element that forms the local pleat may comprise two or more substantially spaced elements having pieces secured together around the tissue. An example of a locking element comprising two separated pieces is shown in FIG. As shown in FIG. 19, the locking element 2000 may comprise a receiving piece 2002 and a securing piece 2004, which are generally formed from substantially any suitable material (eg, a biocompatible plastic material). obtain. Receiving piece 2002 and stationary piece 2004 each comprise a sharp tip 2006. Sharp tip 2006 is adapted to penetrate and engage tissue to create a local fold.

  The cable tie portion 2010 of the fixed piece 2004 is designed to be pulled through an opening 2008 that engages the cable tie portion 2010. The opening 2008 includes features that allow the cable tie portion 2010 to be pulled through the opening 2008 and secured in place, and prevent the cable tie portion 2010 from being substantially pushed out of the opening 2008. (Not shown). The cable tie portion 2010 is secured to the opening 2008 when the bevel 2012 contacts and effectively tightens the sharp tip 2006. Once the sharp tip 2006 is tightened, the securing piece 2004 is secured to the receiving piece 2002 and a local fold is formed.

  Operation of the locking element 2000 is described with respect to FIGS. 20a-d according to an embodiment of the present invention. As shown in FIG. 20a, the receiving strip 2002 and the securing strip 2004 can be delivered substantially below the fibrous tissue 2050 near the mitral valve (not shown). Receiving strip 2002 and stationary strip 2004 may be delivered using a catheter with a top surface 2054. The upper surface 2054 of this catheter is such that the sharp tip 2006 is effectively maintained in a non-deployed position (eg, a partially bent or partially folded position) while being delivered by the catheter. In addition, it is arranged so as to apply a force to the sharp tip 2006.

  Once the receiving piece 2002 and the fixed piece 2004 are placed under the tissue 2050 near the location where the plication is to be formed, the receiving piece 2002 and the fixed piece 2004 are placed in the receiving piece 2002 and the receiving piece 2002 and as shown in FIG. A force is applied to push the fixed pieces 2004 together and effectively through the opening 2058 of the upper surface 2054 of the catheter. This force is typically applied by a mechanism (not shown) associated with the catheter. When sharp tip 2006 passes through opening 2058, sharp tip 2006 is “opened” or deployed to penetrate tissue 2050.

  After penetrating tissue 2050, sharp tip 2006 continues to penetrate tissue 2050 and continue to collect tissue 2050 while receiving piece 2002 and stationary piece 2004 are extruded together. As the receiving piece 2002 and the fixed piece 2004 are extruded together, the cable tie portion 2010 is inserted into the opening 2008 (shown in FIG. 19) of the receiving portion 2002, as shown in FIG. 20c. The cable tie portion 2010 eventually secures with respect to the opening 2008 when the ramp 2012 contacts. When the ramp 2012 contacts, the sharp tip 2006 closes inward and the tissue 2050 is captured (ie, a local pleat 2060 is formed). Once the local folds are formed and the force is no longer required to push the receiving piece 2002 and the fixed piece 2004 together, the catheter delivering the receiving piece 2002 and the fixed piece 2004 is removed from the left ventricle. obtain.

  Referring now to FIGS. 21a and 21b, an annuloplasty procedure that uses a catheter-based system to create local folds in tissue near the mitral valve using separate elements is an embodiment of the present invention. Is described according to After the patient is prepared, the annuloplasty procedure 2100 may begin at step 2104 with insertion of a delivery tube and J-shaped catheter into the left ventricle of the patient's heart. Once the delivery tube and the J-shaped catheter are placed in the left ventricle, the groove catheter can be extended through the J-shaped catheter in step 2108. Groove catheters such as those described above are effectively manipulated against the groove in the left ventricular wall (eg, between the mitral valve and the papillary muscle). Groove catheters often have a steerable and flexible tip.

  In step 2112, a guidewire having an anchoring device can be delivered through the sulcus catheter (eg, through the lumen or opening of the sulcus catheter). The guide wire is delivered through the sulcus catheter to follow the sulcus catheter profile relative to the left ventricular wall. After the guidewire is delivered, the guidewire anchoring device is anchored to the left ventricular wall at step 2116.

  The J-shaped catheter and the sulcus catheter are withdrawn from the left ventricle through the femoral artery in step 2120, with the guidewire anchored to the left ventricle, as described above with respect to FIG. A plication element delivery catheter possessing a plication element and adapted to engage the plication element with the fibrous tissue surrounding the mitral valve in one embodiment is provided in step 2132 over the guide wire over the femoral artery. Through the left ventricle. The plication element delivery catheter, in the described embodiment, is coupled to a non-inflatable balloon, which in step 2134 effectively ensures that the plication element delivery catheter is positioned substantially directly below the fibrous tissue. Inflated to allow for. Once the pleating element delivery catheter is placed in the left ventricle (eg, over the guidewire in the left ventricular groove) and the balloon is inflated, the pleating element delivered by the delivery catheter is a fiber in step 2136. Engage with tissue. That is, the pleat-forming element is connected to the fibrous structure and as a result is formed in the local pleated fibrous structure.

  In step 2136, the balloon is deflated in step 2138 after the local pleat has been created by engaging the tissue with a plication element. In deflating the balloon, the plication element delivery catheter can be removed through the femoral artery in step 2140. A determination is then made at step 2142 whether additional local pleats are created. That is, it is determined whether other plication elements are introduced into the left ventricle. If it is determined that additional local plications will be made, the process flow returns to step 2132 and a plication element delivery catheter carrying another plication element is reinserted into the femoral artery.

  Alternatively, if it is determined in step 2142 that no more local folds are created, this is an indication that a sufficient number of local folds have already been created. Thus, at step 2148, the guidewire can be removed and at step 2152, the delivery tube can be removed. After the delivery tube is removed, the annuloplasty procedure is complete.

  Although only some embodiments of the invention have been described, it should be understood that the invention can be embodied in many other specific forms without departing from the spirit or scope of the invention. is there. By way of example, a method of introducing a pleating element or suture structure in the left ventricle to correct mitral valve leakage or mitral valve failure introduces a pleating element or suture structure that corrects leakage in other valves Can be applied to. For example, the above procedure can be adapted for use in repairing a leak valve associated with the right ventricle.

  Although it has been generally described to create local folds in the fibrous tissue associated with the mitral valve of the heart, this fold can also be near, surrounding, proximal, or that of the mitral valve. It can also be made in other types of tissues including. Other tissues that can be pleated include tissue associated with the myocardium or tissue associated with the left ventricular wall. In one embodiment, the folds can be formed substantially directly on the mitral leaflet.

  Although the guidewire is described as including an anchoring tip for anchoring the guidewire to the left ventricular wall, the guidewire can be anchored in substantially any suitable manner relative to the left ventricle. Should be understood. As an example, the guidewire may include a mooring device located at a location remote from the tip of the guidewire. In addition, the guidewire may more generally be any suitable guide element designed to facilitate placement of the implant.

  Although the use for the left ventricular groove has been described in connection with a minimally invasive catheter annuloplasty procedure that is locally pleated, the left ventricular groove can also be applied locally, eg, for an annuloplasty procedure. It should be understood that it can be utilized as part of a surgical procedure for plication. For example, the aorta of the heart can be utilized throughout an open surgical procedure before a catheter is inserted into the aorta to reach the left ventricle. Alternatively, a suture structure or plication element can be introduced to the ventricular side of the mitral valve through the ventricular wall utilized throughout the open surgical procedure.

  Pledgets are described to be used in combination with or as part of a suture structure to promote the growth of scar tissue as a result of an annuloplasty procedure. However, it should be understood that the use of pledget is optional. Furthermore, although pledgets are generally not described for use with clip elements that create local pleats, it is understood that pledgets can also be implemented with clip elements. Should. By way of example, without departing from the spirit or scope of the present invention, a clip element that includes a sharp tip may be configured to penetrate the pledget before engaging the tissue.

  If the clip element has a sharp tip that is allowed to penetrate through the pledget before engaging the tissue, the pledget is threaded across the guidewire placed in the groove of the left ventricle. It can be a hollow, substantially conical pledget that can be delivered to the skin. The clip element can then be delivered by a catheter through the pledget. A substantially conical hollow pledget used with the suture structure can also be delivered over the guidewire, and then the suture structure can be delivered through the pledget. Delivery of the suture structure through the pledget may allow the thread loop that is maintained after the suture structure is secured in place to be substantially maintained within the pledget.

  The configuration of the clip element can generally vary widely. In particular, the shape of the clip element, the size of the clip element, and the material from which the clip element is formed can vary widely. For example, in addition to clip elements formed from a shape memory material that is pre-filled or self-fixed using a mechanical structure, the clip elements can also be formed from a thermally expandable material. That is, the clip can be formed to be in an open or flat position when delivered to the left ventricle. Such clips are external or “bottom” elements that have a relatively high coefficient of thermal expansion, and internal elements that deform under the addition created by the external element when heat is applied and the external element bends or “ It may have a “top” element. Such clips can penetrate tissue once bent or deformed through the application of heat. If more heat is applied, the clip can bend more so that the tissue engages between the ends or sides of the clip to form local folds. In such a system, the internal material can be made to maintain its deformed shape once heat is no longer applied, and heat can be applied through the catheter.

  Suture structures and plication elements are described as used to correct mitral valve insufficiency. In general, suture structures and plication elements can also be used to inherently prevent the development of mitral valve failure. That is, local pleats can be created to effectively stop the progression of mitral valve insufficiency that strengthens the perimeter of the ring around the mitral valve.

  When a suture structure comprising a T-bar, thread, and locking element and delivered to the left ventricle using a catheter can be used to form separate pleats in the fibrous tissue around the mitral valve, the suture It should be understood that can also be sewn into the fibrous structure. For example, a catheter inserted into the left ventricle through the aorta can be configured to sew sutures to the fibrous tissue using a mechanism held by the catheter. Such sutures that are sewn into the fibrous tissue can be sewn in any conventional direction (eg, in an arc along the perimeter of the mitral posterior leaflet).

  A suture structure comprising a T-shaped bar generally has two T-shaped bars disposed at the end of the thread, together with a locking disposed between them, for example as shown in FIG. 10a. It is described to include elements and pledgets. However, the configuration of the suture structure can vary widely. As an example, a suture structure having two T-shaped bars may comprise one T-shaped bar at one end of the thread and a second T-shaped bar positioned along the thread, so that Pulling on the open end of the yarn pulls the two T-bars together. Alternatively, the suture structure may comprise more than two T-shaped bars.

  In general, the use of a single element type has been described for creating local pleats during an annuloplasty procedure. It should be understood that in one embodiment, different element types can be used in a single annuloplasty procedure. For example, both clip elements and suture elements can be used to create pleats during a single annuloplasty procedure. Alternatively, different types of clip elements or different types of suturing elements can be used during a particular annuloplasty procedure.

  The processes associated with performing catheter-based annuloplasty can vary widely. Steps may generally be added, removed, reordered, and changed without departing from the spirit or scope of the present invention. Accordingly, the embodiments of the invention are to be regarded as illustrative and not restrictive, and the invention is not limited to the details provided herein but may be modified within the scope of the appended claims.

FIG. 1 is a front cross-sectional view of the left side of a human heart. 2a is a cut-away top view of the mitral and aortic valve of FIG. FIG. 2b is a cutaway view of the extended mitral and aortic valve. FIG. 3 is a schematic diagram of an annular ring suitable for use in performing a conventional annuloplasty procedure. FIG. 4 is a schematic view of the mitral and aortic valves after the annular ring of FIG. 3 has been implanted. FIG. 5a is a schematic illustration of a mitral and aortic valve after a single edge-to-edge suture has been adapted to reduce the mitral valve regurgitation. FIG. 5b is a schematic illustration of the mitral and aortic valve after suturing along the mitral valve annulus has been adapted to reduce mitral valve regurgitation. FIG. 6a is a schematic diagram of a delivery tube and a J-shaped catheter according to an embodiment of the present invention. 6b is a cutaway front view of the left side of the heart with the delivery tube and J-shaped catheter of FIG. 6a inserted according to an embodiment of the present invention. FIG. 7a is a schematic illustration of a catheter assembly according to an embodiment of the present invention. FIG. 7b is a cross-sectional view of the catheter assembly of FIG. 7a according to an embodiment of the present invention. FIG. 7c is a cutaway top view of the left ventricle with the groove catheter of FIGS. 7a and 7b positioned in accordance with an embodiment of the present invention. FIG. 8 is a cutaway top view of the left ventricle with the guidewire positioned in accordance with an embodiment of the present invention. FIG. 9a is a top cutaway view of the left ventricle of a heart in which a local plication suture structure is being implanted according to an embodiment of the present invention. FIG. 9b is a cutaway top view of the left ventricle with the connected local plication suture structure implanted according to an embodiment of the present invention. FIG. 10a is a schematic view of the suture structure after a T-bar has been introduced to the arterial side of the mitral valve through the fibrous tissue near the mitral valve, according to an embodiment of the present invention. FIG. 10b is a schematic illustration of the suture structure of FIG. 10a after a T-bar is engaged with fibrous tissue near the mitral valve according to an embodiment of the present invention. FIG. 11 is a schematic view of a suturing structure including a locking element comprising a spring according to an embodiment of the present invention. FIG. 12a is a schematic illustration of a suturing structure including a locking element comprising an absorbent component according to an embodiment of the present invention. FIG. 12b is a schematic illustration of the suture structure of FIG. 12a after the absorbent component has been disassembled in accordance with an embodiment of the present invention. FIG. 12c is a schematic view of the suture structure of FIG. 12b after the pleat has been made in accordance with an embodiment of the present invention. FIG. 13a is a schematic illustration of a first catheter suitable for use in delivering and providing a suture structure in accordance with an embodiment of the present invention. FIG. 13b is a schematic illustration of a second catheter suitable for use in delivering and providing a suture structure in accordance with an embodiment of the present invention. FIG. 13c is a schematic illustration of a third catheter suitable for use in delivering and providing a suture structure in accordance with an embodiment of the present invention. FIG. 14a is a process flow diagram illustrating the steps associated with one method of forming an annulus using a system using a suture structure and a catheter in accordance with an embodiment of the present invention. FIG. 14b is a process flow diagram illustrating the steps associated with one method of forming an annulus using the system with a suturing structure and a catheter in accordance with an embodiment of the present invention. FIG. 15 is a cutaway front view of the left ventricle of the heart with a local pleat element implanted according to an embodiment of the present invention. FIG. 16a is a schematic illustration of a local pleat element having spring-like properties according to an embodiment of the present invention. FIG. 16b is a schematic illustration of the local pleat element of FIG. 16a after a force has been applied to the opening in accordance with an embodiment of the present invention. FIG. 16c is a schematic illustration of the local pleat element of FIG. 16b after the tip of the local pleat element has penetrated tissue in accordance with an embodiment of the present invention. FIG. 16d is a schematic illustration of the local pleat element of FIG. 16c after the tip of the local pleat element engages tissue to form a local pleat in accordance with an embodiment of the present invention. FIG. 17a is a schematic illustration of a local pleat element (opened) formed from a shape memory material according to an embodiment of the present invention. FIG. 17b is a schematic view of the local pleat element (closed state) of FIG. 17a according to an embodiment of the present invention. FIG. 18a is a schematic illustration of a first self-locking clip suitable for use to form a local pleat according to an embodiment of the present invention. FIG. 18b is a schematic illustration of a second self-locking clip suitable for use to form a local pleat in accordance with an embodiment of the present invention. FIG. 19 is a schematic view of a plication fabrication locking mechanism according to an embodiment of the present invention. FIG. 20a is a schematic illustration of the plication fabrication locking mechanism of FIG. 19 when provided in the left ventricle of the heart according to an embodiment of the present invention. FIG. 20b is a schematic diagram of the plication lock mechanism of FIG. 20a after a force has been adapted to bring the teeth of this mechanism into contact with tissue in accordance with an embodiment of the present invention. FIG. 20c is a schematic illustration of the plication fabrication and fixation mechanism of FIG. 20b after tissue has been collected between the teeth of the mechanism in accordance with an embodiment of the present invention. FIG. 20d is a schematic illustration of the plication fabrication locking mechanism of FIG. 20c after a local pleat has been formed in accordance with an embodiment of the present invention. FIG. 21a is a process flow diagram illustrating the steps associated with one method of annuloplasty using a local pleat element and a catheter, in accordance with an embodiment of the present invention. FIG. 21b is a process flow diagram illustrating the steps associated with one method of annuloplasty using a local plication element and a catheter, in accordance with an embodiment of the present invention.

Claims (3)

A system for use in a method for performing an annuloplasty comprising:
A catheter and a first plication element, wherein the first plication element includes a plurality of bar portions, a thread, and a lock, wherein the par part and the lock are coupled to the thread; ,
Using the catheter to access tissue located near the mitral valve of the heart through the left ventricle of the heart,
Providing the first plication element through the catheter;
Using the first plication element and catheter to produce a first separate plication in the tissue, the first plication element being positioned to reduce the arc length of the mitral valve; In a system for producing a first separate plication in the tissue using a plication element and a catheter, the method comprises:
(A) penetrating the tissue and positioning the bar portion on the atrial side of the tissue;
(B) tensioning the thread and placing it against the atrial side of the tissue to position the bar portion;
(C) positioning the lock against the ventricular side of the tissue and positioning the lock against the ventricular side of the tissue so that the first pleat is substantially between the bar portion and the lock. A system characterized by causing formation.   The system of claim 1, wherein the catheter is configured to cause the first separate plication to occur in the first plication device. The system further includes a second plication element, and the method comprises:
Using the second pleat forming element to produce a second separate pleat formation in the tissue, wherein the second pleat forming element is substantially separated from the first pleat forming element. The system of claim 1.

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