Patent Application
20230363908
The present invention relates to minimally invasive delivery of a suture into the heart. More particularly, the disclosed embodiments relate to inserting and anchoring one or more sutures as artificial chordae tendineae for a flailing or prolapsing leaflet in a beating heart.
The mitral and tricuspid valves inside the human heart include an orifice (annulus), two (for the mitral) or three (for the tricuspid) leaflets and a subvalvular apparatus. The subvalvular apparatus includes multiple chordae tendineae, which connect the mobile valve leaflets to muscular structures (papillary muscles) inside the ventricles. Rupture or elongation of the chordae tendineae results in partial or generalized leaflet prolapse, which causes mitral (or tricuspid) valve regurgitation. A commonly used technique to surgically correct mitral valve regurgitation is the implantation of artificial chordae (usually 4-0 or 5-0 Gore-Tex sutures) between the prolapsing segment of the valve and the papillary muscle.
This technique for implantation of artificial chordae was traditionally done by an open heart operation generally carried out through a median sternotomy and requiring cardiopulmonary bypass with aortic cross-clamp and cardioplegic arrest of the heart. Using such open heart techniques, the large opening provided by a median sternotomy or right thoracotomy enables the surgeon to see the mitral valve directly through the left atriotomy, and to position his or her hands within the thoracic cavity in close proximity to the exterior of the heart for manipulation of surgical instruments, removal of excised tissue, and/or introduction of an artificial chordae through the atriotomy for attachment within the heart. However, these invasive open heart procedures in which the heart is stopped beating produce a high degree of trauma, a significant risk of complications, an extended hospital stay, and a painful recovery period for the patient. Moreover, while heart valve surgery produces beneficial results for many patients, numerous others who might benefit from such surgery are unable or unwilling to undergo the trauma and risks of such open heart techniques.
Techniques for minimally invasive thoracoscopic repair of heart valves while the heart is still beating have also been developed. U.S. Pat. No. 8,465,500 to Speziali, which is incorporated by reference herein, discloses a thoracoscopic heart valve repair method and apparatus. Instead of requiring open heart surgery on a stopped heart, the thoracoscopic heart valve repair methods and apparatus taught by Speziali utilize fiber optic technology in conjunction with transesophageal echocardiography (TEE) as a visualization technique during a minimally invasive surgical procedure that can be utilized on a beating heart. More recent versions of these techniques are disclosed in U.S. Pat. Nos. 8,758,393 and 9,192,374 to Zentgraf, which are also incorporated by reference herein and disclose an integrated device that can enter the heart chamber, navigate to the leaflet, capture the leaflet, confirm proper capture, and deliver a suture as part of a mitral valve regurgitation (MR) repair. In some procedures, these minimally invasive repairs are generally performed through a small, between the ribs access point followed by a puncture into the ventricle through the apex of the heart. Although far less invasive and risky for the patient than an open heart procedure, these procedures still require significant recovery time and pain.
Some systems have therefore been proposed that utilize a catheter routed through the patient's vasculature to enter the heart and attach a suture to a heart valve leaflet as an artificial chordae. While generally less invasive than the approaches discussed above, transcatheter heart valve repair can provide additional challenges. For example, with all artificial chordae replacement procedures, in addition to inserting a suture through a leaflet, the suture must also be anchored at a second location, such as at a papillary muscle in the heart, with a suture length, and tension and positioning of the suture should be adjustable to enable the valve to function naturally. If the suture is too short and/or has too much tension, the valve leaflets may not properly close. Conversely, if the suture is too long and/or does not have enough tension, the valve leaflets may still be subject to prolapse. Proper and secure anchoring of the suture at the second position away from the leaflet is therefore a critical aspect of any heart valve repair procedure for inserting an artificial chordae. In the case of transcatheter procedures, such anchoring can be difficult because it can be difficult for the flexible catheter required for routing through the patient's vasculature to apply sufficient force to stably insert traditional suture anchors into the heart wall, e.g., the myocardium.
Disclosed herein are embodiments of cardiac anchors configured to be inserted into a heart wall of a patient to anchor a suture as an artificial chordae under an appropriate tension for proper valve function. Such cardiac anchors are particularly suitable for use in intravascular, transcatheter procedures.
In an embodiment, an anchor assembly configured to be implanted into a heart wall of a heart of a patient to anchor a suture that is configured to extend from a valve leaflet of the heart as an artificial chordae can include an anchor hub having a proximal drive socket configured to interface with a delivery tool and defining an outer clamp surface and a helical coil extending distally from the anchor hub and having a sharpened tip configured to embed the helical coil into the heart wall upon rotation of the helical coil caused by the delivery tool interfacing with the drive socket. A spring crimp can have an open position and a closed position with the crimp biased towards the closed position. A locking element can be configured to interface with the spring crimp to selectively hold the spring crimp in the open position. Removal of the locking element from the spring crimp with the spring crimp positioned over the anchor hub can cause the spring crimp to clamp onto the outer clamp surface of the anchor hub with sufficient force to hold a suture between the spring crimp and the outer clamp surface under tension.
In an embodiment, an anchor assembly configured to be implanted into a heart wall of a heart of a patient to anchor a suture that is configured to extend from a valve leaflet of the heart as an artificial chordae can include an anchor configured to be inserted into a heart wall of a patient. A spring crimp can have an open position and a closed position with the crimp biased towards the closed position. A locking element can be configured to interface with the spring crimp to selectively hold the spring crimp in the open position. Removal of the locking element from the spring crimp with the spring crimp positioned over the anchor hub can cause the spring crimp to clamp onto the outer clamp surface of the anchor hub with sufficient force to hold a suture between the spring crimp and the outer clamp surface under tension.
In an embodiment, an anchor assembly can be configured to be implanted into a heart wall of a heart of a patient to anchor a suture that is configured to extend from a valve leaflet of the heart as an artificial chordae. The anchor assembly can include a spring crimp having an open position and a closed position with the spring crimp being biased towards the closed position and including one or more locking rings. A locking element can be configured to be inserted through the one or more locking rings of the spring crimp to selectively hold the spring crimp in the open position, wherein removal of the locking rod from the one or more locking rings of the spring crimp with the spring crimp positioned over a suture anchor causes the spring crimp to clamp onto the outer clamp surface of the suture anchor with sufficient force to hold a suture between the spring crimp and the suture anchor under tension as an artificial chordae extending from the valve leaflet to the suture anchor.
The above summary is not intended to describe each illustrated embodiment or every implementation of the subject matter hereof. The figures and the detailed description that follow more particularly exemplify various embodiments.
Subject matter hereof may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying figures, in which:
While various embodiments are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the claimed inventions to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the claims.
The present disclosure is generally directed to inserting and anchoring one or more sutures as artificial chordae into one or more heart valve leaflets through an intravascular, transcatheter approach. A heart valve leaflet may be captured and a suture inserted through the leaflet in any manner known in the art. Examples of such leaflet capture catheters are disclosed in copending U.S. Patent Publication No. 2019/0290260 and U.S. patent application Ser. No. 16/564,887, each of which is hereby incorporated by reference herein. Other transcatheter procedures for inserting an artificial chordae are disclosed in U.S. Patent Publication No. 2016/0143737 and U.S. patent application Ser. No. 16/745,074, each of which is hereby incorporated by reference herein. In other embodiments, artificial chordae can be inserted through transapical, open, or any other approach.
In embodiments, access into the heart to the valve being repaired can be gained through an intravascular, transcatheter approach. If the valve being repaired is the mitral valve, the valve may further be accessed transseptally.
In embodiments, the anchor coil 102 can be wound from a medical, implantable grade stainless steel wire, such as, for example 31LVM stainless steel, or other implantable grade, high-tensile metals. The diameter of the wire forming the coil 102 can be large enough to create an effectively rigid coil with respect to the tissue to allow the coil to be directed and turned into the tissue from the proximal end of the system, while still controlling the distal tip of the coil such that it will engage the tissue in a helical path as it is delivered. In embodiments, a wire diameter of 0.080″ with a pitch of 0.100″ along the coil enables the necessary control while enabling a sufficient amount of tissue to exist within the helical coil to ensure good engagement without disrupting the tissue to compromise the ability of the tissue to heal around the anchor or cause tissue necrosis. The total axial length of the coil can be sized to engage as much cardiac tissue as possible to provide secure anchoring while limiting the risk of perforation of the ventricle (i.e., the anchor extending completely through the heart wall). Average ventricular tissue thickness has been found to generally be within the range of 10-12 mm. In embodiments, a total length of the tissue engaging portion of the coil can be 7-9 mm to provide an appropriate balance of maximization of tissue engagement for secure anchoring while limiting risk of perforation.
Due to the complex contractile motion of cardiac tissue at any specific anchoring point within the myocardium, features to resist any anti-rotation of the of the coil back out of the myocardium after the anchor is implanted can be included such as one or more barbs attached to the anchor coil as noted above. In embodiments, the barb(s) can be safely attached to the coil by welding, such as, for example, by anchor welding. In embodiments, the barb can extend from about 0.025″ to 0.040″ outwardly from the profile of the coil and the tip of the barb can be bent proximally. Such a configuration reduces the insertion force with respect to the back-out force to provide more stability to the implanted anchor. The barb(s) can be oriented on the helical coil to reduce the potential of interaction between the barb(s) and a suture. As the coil is inserted, the suture is pressed, by the distal facing portions of the anchor coil, against the tissue as the coil is screwed into the tissue. The suture will remain at the tissue surface of the anchor site while the coil effectively passes by the suture leaving the suture trapped between the tissue surface and the distal surface of the coil as the coil is inserted. Because of this interaction, orientation and placement of the barb(s) is effected to keep the suture from interacting with the barb(s) which could result in potentially tangling or damage of the suture.
Referring now to
In some embodiments, one or more sutures 30 can have been previously inserted into a leaflet 32 prior to insertion of the anchor 100 into the heart tissue. In other embodiments, the anchor 100 can be inserted first and then one or more sutures inserted through a leaflet. Once the anchor 100 has been seated, a suture 30 can be threaded through the opening 114 in spring crimp 110 outside of the body. The spring crimp 110 can be attached to a delivery catheter 34 that is routed through guide catheter 20 into the heart. As can be seen in
Referring to
Referring now to
In embodiments, an anchor assembly configured to be implanted into a heart wall of a heart of a patient to anchor a suture that is configured to extend from a valve leaflet of the heart as an artificial chordae can include an anchor hub having a proximal drive socket configured to interface with a delivery tool and defining an outer clamp surface and a helical coil extending distally from the anchor hub and having a sharpened tip configured to embed the helical coil into the heart wall upon rotation of the helical coil caused by the delivery tool interfacing with the drive socket. A spring crimp can have an open position and a closed position with the crimp biased towards the closed position. A locking element can be configured to interface with the spring crimp to selectively hold the spring crimp in the open position. Removal of the locking element from the spring crimp with the spring crimp positioned over the anchor hub can cause the spring crimp to clamp onto the outer clamp surface of the anchor hub with sufficient force to hold a suture between the spring crimp and the outer clamp surface under tension.
In some embodiments, the spring crimp comprises one or more locking rings, and the locking element interfaces with the one or more locking rings to hold the spring crimp in the open position.
In some embodiments, the spring crimp comprises a pair of locking rings that are axially aligned in the open position.
In some embodiments, the locking element is configured as an elongate rod.
In some embodiments, the elongate rod is inserted through one or more openings in the suture crimp to hold the suture crimp in the open position.
In some embodiments, the elongate rod is configured to be moved proximally relative to the anchor to be removed from the spring crimp.
In some embodiments, the elongate rod is configured to extend from the anchor inserted into the heart wall thorough the patient's vasculature and outside of the body.
In embodiments, an anchor assembly configured to be implanted into a heart wall of a heart of a patient to anchor a suture that is configured to extend from a valve leaflet of the heart as an artificial chordae can include an anchor configured to be inserted into a heart wall of a patient. A spring crimp can have an open position and a closed position with the crimp biased towards the closed position. A locking element can be configured to interface with the spring crimp to selectively hold the spring crimp in the open position. Removal of the locking element from the spring crimp with the spring crimp positioned over the anchor hub can cause the spring crimp to clamp onto the outer clamp surface of the anchor hub with sufficient force to hold a suture between the spring crimp and the outer clamp surface under tension.
In some embodiments, the spring crimp comprises one or more locking rings, and the locking element interfaces with the one or more locking rings to hold the spring crimp in the open position.
In some embodiments, the spring crimp comprises one or more locking rings, and the locking element interfaces with the one or more locking rings to hold the spring crimp in the open position.
In some embodiments, the spring crimp comprises one or more locking rings, and wherein the locking element interfaces with the one or more locking rings to hold the spring crimp in the open position.
In some embodiments, the spring crimp comprises one or more locking rings, and wherein the locking element interfaces with the one or more locking rings to hold the spring crimp in the open position.
In some embodiments, the spring crimp comprises a pair of locking rings that are axially aligned in the open position.
In some embodiments, the locking element is configured as an elongate rod.
In some embodiments, the elongate rod is inserted through one or more openings in the suture crimp to hold the suture crimp in the open position.
In some embodiments, the elongate rod is configured to be moved proximally relative to the anchor to be removed from the spring crimp.
In some embodiments, the elongate rod is configured to extend from the anchor inserted into the heart wall thorough the patient's vasculature and outside of the body.
In embodiments, an anchor assembly can be configured to be implanted into a heart wall of a heart of a patient to anchor a suture that is configured to extend from a valve leaflet of the heart as an artificial chordae. The anchor assembly can include a spring crimp having an open position and a closed position with the spring crimp being biased towards the closed position and including one or more locking rings. A locking element can be configured to be inserted through the one or more locking rings of the spring crimp to selectively hold the spring crimp in the open position, wherein removal of the locking rod from the one or more locking rings of the spring crimp with the spring crimp positioned over a suture anchor causes the spring crimp to clamp onto the outer clamp surface of the suture anchor with sufficient force to hold a suture between the spring crimp and the suture anchor under tension as an artificial chordae extending from the valve leaflet to the suture anchor.
In some embodiments, the spring crimp comprises a pair of locking rings that are axially aligned in the open position.
In some embodiments, the locking element is configured as an elongate rod.
In some embodiments, the elongate rod is inserted through one or more openings in the suture crimp to hold the suture crimp in the open position.
In some embodiments, the elongate rod is configured to be moved proximally relative to the anchor to be removed from the spring crimp.
In some embodiments, the elongate rod is configured to extend from the anchor inserted into the heart wall thorough the patient's vasculature and outside of the body.
Various other anchors can be interchangeably employed in each of the above-described systems. Such anchors can include those disclosed in U.S. Patent Application Publication Nos. 2019/0343626; 2019/0343633; 2019/0343634; 2020/0330228; and 2021/0220138, which are hereby incorporated by reference.
Various embodiments of systems, devices, and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the claimed inventions. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, configurations and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the claimed inventions.
Persons of ordinary skill in the relevant arts will recognize that the subject matter hereof may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter hereof may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the various embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted.
Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended.
Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein.
For purposes of interpreting the claims, it is expressly intended that the provisions of 35 U.S.C. § 112(1) are not to be invoked unless the specific terms “means for” or “step for” are recited in a claim.
This application claims the benefit of U.S. Provisional Application No. 63/341,697 filed May 13, 2022, which is hereby fully incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63341697 | May 2022 | US |
