Self-stopping tissue anchor

Abstract

A tissue anchor (12, 12') includes an anchoring portion (34) and a crown (38) coupled thereto. The crown includes an anchor head (30) fixedly coupled to the anchoring portion, a driver interface (41), and a socket (24). The socket can be fixedly coupled to the driver interface and shaped to receive the anchor head. In a first state, the anchor head is snugly seated within the socket such that torque applied to the driver interface is transmitted to the anchoring portion, thereby facilitating screwing of the anchoring portion into tissue. Screwing of the anchoring portion into tissue pulls the anchor head distally out of the socket, thereby transitioning the anchor to a second state in which torque applied to the driver interface rotates the socket relative to the anchor head and the anchoring portion. Other embodiments are also described.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application 63 / 041,423, filed June 19, 2020, to Brauon et al., which is incorporated herein by reference. Background Technology

[0003] Tissue anchors can be used in a range of medical applications (e.g., for securing implants to tissue). Screw-in tissue anchors can be configured to convert torque into distal motion, thereby screwing the anchor (e.g., its anchoring portion) into the tissue. Summary of the Invention

[0004] This summary is intended to provide examples and is not intended to limit the scope of the invention in any way. For example, any feature included in the examples of this summary is not claimed unless the claim expressly recites that feature. Furthermore, the features, components, steps, concepts, etc., described in the examples of this summary and elsewhere in this disclosure can be combined in various ways. Various features and steps as described elsewhere in this disclosure can be included in the examples summarized herein.

[0005] Some applications described in this article involve tissue anchors that facilitate the controlled anchoring of tissue anchors into a subject's tissue, such as cardiac tissue. That is, the tissue anchor itself includes features that contribute to this control. For some applications, additional devices or system components(s), such as anchor drivers, are provided for screwing the anchoring portion of the tissue anchor into the tissue.

[0006] For some applications, tissue anchors limit the amount of torque that can be used to screw the anchor into the tissue. For others, tissue anchors limit the depth to which they can be screwed into the tissue.

[0007] Some tissue anchors described herein may include an anchoring portion and a crown attached to the anchoring portion. The crown may include an anchor head, a drive interface, and a socket. The anchor head may be securely attached to the anchoring portion. The socket may be securely attached to the drive interface and may be further shaped to receive the anchor head. In a first state, the anchor head is tightly seated within the socket, such that torque applied to the drive interface is transmitted to the anchoring portion, thereby facilitating the screwing of the anchoring portion into the tissue. Screwing the anchoring portion into the tissue involves pulling the anchor head distally out of the socket, thereby transforming the anchor into a second state in which the torque applied to the drive interface rotates the socket relative to the anchor head and the anchoring portion, for example, such that torque is no longer transmitted to the anchoring portion, for example, making it impossible to screw the anchoring portion further into the tissue.

[0008] Some tissue anchors described herein may include a crown comprising an anchor head securely attached to an anchor portion. The crown may define a actuator interface configured for engagement by an actuator. The crown may also define a tissue-facing surface such that screwing the anchor portion into the tissue causes the tissue-facing surface to move distally toward the tissue.

[0009] For some applications, the crown may include a socket that can be securely coupled to the actuator interface and is shaped to receive the anchor head. For some such applications, the tissue anchor may have (i) a torque-transmitting state in which the anchor head is positioned within the socket such that torque applied by the actuator to the actuator interface rotates the socket, the anchor head, and the anchor portion, thereby screwing the anchor portion into the tissue, and (ii) a non-torque-transmitting state in which the anchor head is positioned distal from the socket such that the applied torque is not transmitted from the interface to the anchor head and the anchor portion (or at least significantly reduced).

[0010] For such applications, the contact between the tissue-facing surface and the tissue can increase resistance to further distal movement of the tissue-facing surface. At this stage, further screwing in of the anchor can pull the anchor head distally out of the socket (e.g., toward the tissue-facing surface), causing the tissue anchor to transition from a torque-transmitting state to a non-torque-transmitting state, thereby limiting the distal force applied to the tissue by the tissue-facing surface.

[0011] For some such applications, tissue anchors may further include a spring disposed between the anchor head and the tissue-facing surface. Pulling the anchor head distally out of the socket and towards the tissue-facing surface compresses the spring between the anchor head and the tissue-facing surface, thereby facilitating continued screwing of the anchored portion into the tissue as the tissue anchor transitions from a torque-transmitting state to a non-torque-transmitting state.

[0012] For some applications, the crown may include a slip clutch that transmits torque from the drive interface to the anchor head while limiting the transmitted torque to a torque threshold.

[0013] In some applications where the crown includes a slip clutch, the slip clutch can transmit torque from the drive interface to the anchor head via a cantilever pin that rotates together with the anchor head about the longitudinal axis of the anchor, while the torque-applying portion of the pin remains in contact with the non-circular outer surface of the anchor head. However, when the applied torque exceeds a torque threshold, the torque-applying portion of the pin deflects away from the anchor head (e.g., due to being pushed laterally outward by the geometry of the anchor head), allowing the drive interface and the pin to rotate relative to the anchor head and anchoring portion, thereby limiting the transmitted torque.

[0014] For some such applications, the deflection of the pin's torque-applied portion away from the anchor head depends on whether the applied torque is forward or reverse. For example, applying a forward torque exceeding a torque threshold will cause the pin to deflect. However, applying a reverse torque exceeding a torque threshold may not cause the pin to deflect. For instance, while the pin remains in contact with the anchor head, it can rotate in the reverse direction of rotation, thereby causing the anchor portion to be unscrewed from the tissue. Assuming this is the case, the anchor can limit the torque required to screw the anchor into the tissue while reliably allowing sufficient torque to loosen the anchor from the tissue.

[0015] In some applications where the crown includes a slip clutch, the anchor head includes a gear shaped to define an outer surface and a notch. In such applications, the slip clutch transmits torque to the gear via a cantilever pin that rotates together with the anchor head about the longitudinal axis of the anchor, while the torque-applying portion of the pin remains in contact with the gear. However, when the applied torque exceeds a torque threshold, the torque-applying portion of the pin deflects away from the gear (e.g., due to being pushed laterally outward by the geometry of the anchor head), causing the drive interface and the pin to rotate relative to the gear and the anchor portion, thereby limiting the transmitted torque.

[0016] For some such applications, the deflection of the pin away from the gear depends on whether the torque applied to the interface is a positive or negative torque. For example, applying a positive torque exceeding a torque threshold will cause the pin to deflect away from the gear. However, applying a negative torque exceeding a torque threshold may not cause the pin to deflect. Instead, the pin can rotate in the opposite direction until the end of the pin is latched in the notch defined by the gear. In this way, the application of negative torque causes the gear and the anchoring portion to rotate together with the drive interface, thereby causing the anchoring portion to be unscrewed from the tissue. It is assumed that in this way, the anchor can limit the torque used to screw the anchor into the tissue while reliably allowing sufficient torque to loosen the anchor from the tissue.

[0017] Therefore, according to some applications, a system and / or device for a subject's tissue is provided, the system and / or device including a driver and a tissue anchor, the tissue anchor including an anchor portion configured to be screwed distally into the tissue by rotation about a longitudinal axis of the anchor and a crown, the crown being coupled to a proximal portion of the anchor portion thereby defining a surface facing the tissue.

[0018] In some applications, the tissue anchor and / or the crown of the tissue anchor includes an anchor head that is fixedly coupled to the anchor portion, such that screwing the anchor portion into the tissue causes the anchor head to move distally along the longitudinal axis toward the tissue and / or the actuator interface, which is configured to be engaged by an actuator.

[0019] In some applications, the system / device includes a socket that is fixedly coupled to the drive interface and is shaped to receive the head of the anchor within the socket, with the tissue-facing surface facing the distal side away from the socket.

[0020] In some applications, the system / device or its tissue anchor has a first state in which the anchor head is tightly seated in the socket, such that torque applied by the actuator to the actuator interface rotates the socket, the anchor head, and the anchor portion, thereby facilitating the screwing of the anchor portion into the tissue.

[0021] In some applications, the system / device or its organization anchor has a second state in which the anchor head is positioned distal to the socket, such that the torque applied by the actuator to the actuator interface rotates the socket relative to the anchor head and the anchor portion.

[0022] In some applications, tissue anchors are configured to transition from a first state to a second state in response to the anchor portion being screwed into the tissue sufficiently deep, such that the tissue pulls the anchor head distally out of the socket while resisting further distal movement of the tissue-facing surface as the anchor portion is screwed into the tissue.

[0023] In some applications, when the driver engages the driver interface, the driver interface defines the chassis that separates the driver from the anchor head.

[0024] In some applications, the anchor head is shaped such that its cross-section defines a non-circular profile. In some applications, the anchor head is shaped such that its cross-section defines multiple outer surfaces. In some applications, the anchor head is shaped such that its cross-section defines a polygon. In some applications, the anchor head is shaped such that its cross-section defines a square. In some applications, the anchor head is shaped such that its cross-section defines a hexagon.

[0025] In some applications, the tissue is tissue from the subject's heart, and tissue anchors can be advanced into the heart via the cavity.

[0026] In some applications, the actuator includes a flexible shaft and an actuator head located at the distal end of the shaft, allowing the anchor actuator to be advanced via the cavity to the heart.

[0027] In some applications, the crown includes a sleeve whose dimensions are defined to include: a driver interface, a socket, a tissue-facing surface, and a free zone disposed between the socket and the tissue-facing surface, and when the anchor is in the second state, the anchor head is disposed within the free zone.

[0028] In some applications, the anchor head is configured to rotate relative to the bearing socket when the anchor head is positioned in the free zone.

[0029] In some applications, the driver includes a driver head that is shaped to define a shoulder located on one side of the driver head and sized such that the shoulder contacts the proximal surface of the sleeve when the driver interface is engaged by the driver head.

[0030] In some applications, the system / device includes a spring disposed within the sleeve, between the anchor head and the tissue-facing surface, and the anchor is configured such that when the anchor changes from a first state to a second state: screwing the anchor portion into the tissue pulls the anchor head distally out of the socket, thereby compressing the spring.

[0031] In some applications, the anchor is configured such that when the anchor changes from a first state to a second state, the anchor portion is screwed into the tissue, the anchor head is pulled distally out of the socket, thereby compressing the spring and pressing the tissue-facing surface against the tissue.

[0032] In some applications, the anchor is configured such that when the anchor changes from a first state to a second state, screwing the anchor portion into the structure pulls the anchor head distally out of the socket, thereby compressing the spring when the anchor head is partially positioned within the socket and partially positioned within the free zone.

[0033] The system and / or device may further include an implant, and a tissue anchor may be configured to secure the implant to tissue. In some applications, the implant includes a tether or a compression member. In some applications, the tissue anchor is configured to secure the tether or compression member to tissue such that applying tension to the tether or compression member alters the shape and / or size of the tissue.

[0034] According to some applications, a system and / or apparatus is further provided, comprising: a drive including a shaft and a drive head located at the distal end of the shaft; and a tissue anchor. The tissue anchor includes an anchoring portion configured to be screwed distally into the tissue by rotation about the longitudinal axis of the anchor.

[0035] In some applications, the organization anchor includes a crown that is attached to the proximal portion of the anchoring part.

[0036] In some applications, the anchor and / or crown includes an anchor head that is fixedly connected to the anchor portion, such that rotation of the anchor head causes the anchor portion to rotate about a longitudinal axis.

[0037] In some applications, the organization anchor, crown, and / or anchor head includes a drive interface configured to engage with the drive head and be rotated by a drive.

[0038] In some applications, the anchor, crown, and / or anchor head includes a slip clutch. In some embodiments, the slip clutch is coupled to a drive interface and / or to the anchor head. In some embodiments, the slip clutch is configured to (i) transmit torque applied to the drive interface to the anchor head up to a torque threshold, and (ii) slip in response to a torque exceeding the torque threshold applied to the drive interface, thereby limiting the torque transmitted to the anchor head to not exceed the torque threshold.

[0039] In some applications, the anchor head is shaped to define a non-circular outer surface, and the slip clutch includes a cantilever pin, a portion of which is fixedly coupled to the drive interface. In some embodiments, the slip clutch is configured to: (i) transmit torque from the drive interface to the anchor head by rotating about a longitudinal axis in response to rotation of the drive interface when the torque-applied portion of the pin contacts the non-circular outer surface of the anchor head; and (ii) slide by deflecting the pin away from the longitudinal axis by the anchor head.

[0040] In some applications, the slip clutch includes a cantilever pin, a portion of which is fixedly coupled to the drive interface, and the slip clutch is configured to slide in response to a torque greater than a torque threshold applied to the drive interface by deflecting the pin away from the longitudinal axis via an anchor head.

[0041] In some applications, the tissue is tissue from the subject's heart, and tissue anchors can be advanced into the heart via the cavity.

[0042] In some applications, the actuator includes a flexible shaft and an actuator head located at the distal end of the shaft, making the anchor actuator semi-transparent to the heart.

[0043] In some applications, a slip clutch is configured to selectively rotatably engage the drive interface with the anchor head, such that: (i) in response to applying torque to the drive interface in a first rotational direction and at a first magnitude not exceeding a torque threshold, the anchor head and anchor portion rotate together with the drive interface in the first rotational direction; in response to applying torque to the drive interface in the first rotational direction and at a second magnitude exceeding the torque threshold, the slip clutch slips, causing the drive interface to rotate relative to the anchor head and anchor portion; and in response to applying torque to the drive interface in a second rotational direction and at a second magnitude, the anchor head and anchor portion rotate together with the drive interface in a second rotational direction, which is opposite to the first rotational direction.

[0044] In some applications, the torque threshold is a first torque threshold, and the organization anchor is configured such that applying torque to the drive interface in a second rotational direction and at a third magnitude exceeding a second torque threshold greater than the first torque threshold causes the slip clutch to slip, causing the drive interface to rotate relative to the anchor head and the anchor portion.

[0045] In some applications, the anchoring portion is oriented relative to the slip clutch such that rotation of the anchor head and the anchoring portion in a first rotational direction facilitates screwing the tissue anchor into the tissue, and rotation of the anchor head and the anchoring portion in a second rotational direction facilitates unscrewing the tissue anchor from the tissue.

[0046] In some applications, the anchor head is shaped to define a non-circular outer surface, and the slip clutch includes a cantilever pin, the fixed portion of which is fixedly connected to the actuator interface. In some embodiments, the slip clutch is configured to transmit torque from the actuator interface to the anchor head by rotating about a longitudinal axis in response to rotation of the actuator interface while the torque-applying portion of the pin contacts the non-circular outer surface of the anchor head, and to slide by deflecting the pin away from the longitudinal axis by the anchor head.

[0047] In some applications, the slip clutch is configured such that a torque is applied to the drive interface in a first rotational direction and at a first magnitude, and the torque-applying portion is positioned ahead of the fixed portion by the rotation of the cantilever pin about the longitudinal axis in the first rotational direction, causing the anchor head and the anchor portion to rotate together with the drive interface.

[0048] In some applications, the slip clutch is configured such that a torque is applied to the drive interface in a first rotational direction and at a first magnitude, and the torque-applying portion is positioned behind the fixed portion by the rotation of the cantilever pin about the longitudinal axis in the first rotational direction, causing the anchor head and the anchor portion to rotate together with the drive interface.

[0049] In some applications, the slipper clutch is configured such that: a first torque-applying portion applies torque to the drive interface in a first rotational direction and with a first magnitude, causing the anchor head and anchor portion to rotate together with the drive interface by the rotation of the cantilever pin about the longitudinal axis in the first rotational direction while the first torque-applying portion contacts the non-circular outer surface of the anchor head. In some embodiments, torque is applied to the drive interface in the first rotational direction and with a second magnitude, causing the drive interface and pin to rotate relative to the anchor head and anchor portion in the first rotational direction by deflection of the pin away from the longitudinal axis by the anchor head. In some embodiments, torque is applied to the drive interface in a second rotational direction and with a second magnitude, causing the anchor head and anchor portion to rotate together with the drive interface in the second rotational direction by the rotation of the cantilever pin about the longitudinal axis in the second rotational direction while a second torque-applying portion of the pin contacts the anchor head.

[0050] In some applications, the slipper clutch is configured such that when torque is applied to the drive interface in a first rotational direction and at a first magnitude, the pin has a positive cantilever span between (i) the fixed portion of the pin and (ii) the first torque-applying portion, and when torque is applied to the drive interface in a second rotational direction, the pin has a negative cantilever span between (i) the fixed portion of the pin and (ii) the second torque-applying portion, the positive cantilever span being longer than the negative cantilever span.

[0051] In some applications, the first torque-applying portion is farther from the fixed portion than the second torque-applying portion. In some applications, the second torque-applying portion is farther from the fixed portion than the first torque-applying portion.

[0052] In some applications: the anchor head is shaped to define a recess, a pin defines a pawl serving as a second torque application portion, and a slip clutch is configured to apply torque to the drive interface in a second rotational direction and at a second size, such that the anchor head and anchor portion rotate together with the drive interface in the second rotational direction by the cantilever pin rotating about a longitudinal axis in the second rotational direction while the pawl is latched in the recess defined by the anchor head.

[0053] In some applications, the slip clutch is configured such that applying torque to the drive interface in the second rotational direction and at a second size causes the drive interface and pin to rotate no more than a quarter turn relative to the anchor head and anchor portion in the second rotational direction before the pawl becomes latched into the notch defined by the anchor head.

[0054] The system and / or device may further include an implant, and a tissue anchor may be configured to secure the implant to tissue. In some applications, the implant includes a tether or a compression member. In some applications, the tissue anchor is configured to secure the tether or compression member to tissue such that applying tension to the tether or compression member alters the shape and / or size of the tissue.

[0055] According to some applications, a method for using tissue in a subject is further provided, comprising advancing a tissue anchor into the tissue, the tissue anchor including an anchor portion, an anchor head and a drive interface, and screwing the anchor portion distally into the tissue by applying torque to the drive interface such that the drive interface and the anchor portion rotate together about the longitudinal axis of the anchor, and continuing to screw the anchor portion distally into the tissue at least until the drive interface becomes rotatable relative to the anchor head.

[0056] In some applications, the organization anchor includes a crown that is coupled to a proximal portion of the anchoring portion, and the crown may include an anchor head that can be securely coupled to the anchoring portion. In some embodiments, the driver interface may also be part of the crown.

[0057] The method may further include engaging a driver (e.g., an anchor driver, etc.) with a driver interface. The method may further include using the driver to apply torque to the driver interface to screw the anchor portion distally into the tissue, such that the driver interface, the anchor head, and the anchor portion rotate together about the longitudinal axis of the anchor.

[0058] The method may further include, after screwing in the anchor, disengaging the driver from the driver interface and removing the driver from the subject, while simultaneously anchoring the tissue anchor to the tissue.

[0059] In some applications, the actuator includes an actuator head shaped to define a shoulder, and the anchor portion is screwed distally into the tissue by applying torque to the actuator interface, including by applying torque to the actuator interface while the actuator head engages with the actuator interface and the shoulder contacts the proximal surface of the coronal portion.

[0060] In some applications, the drive interface defines the chassis, and the anchoring portion is screwed distally into the tissue by applying torque to the drive interface, including using the drive head to contact the chassis.

[0061] In some applications, the tissue is tissue of the subject's heart, and advancing the tissue anchor into the tissue involves advancing the tissue anchor through the lumen into the heart. In some embodiments, the tissue is tissue of the mitral or tricuspid valve of the heart.

[0062] In some applications, the actuator includes a flexible shaft and an actuator head located at the distal end of the shaft, and the method includes using the flexible shaft to insert the actuator head into the actuator interface via a cavity after advancing the tissue anchor into the tissue.

[0063] In some applications, the crown is shaped to define: a socket fixedly connected to the actuator interface, and a tissue-facing surface distally away from the socket; and screwing the anchor portion distally into the tissue includes screwing the anchor portion distally into the tissue by applying torque to the actuator interface while the anchor head is tightly seated in the socket, such that the actuator interface, socket, anchor head, and anchor portion rotate about a longitudinal axis; and continuing to screw the anchor portion distally into the tissue includes continuing to screw the anchor portion distally into the tissue at least until: the tissue resists further distal movement of the tissue-facing surface, and the anchor head is pulled distally from the socket, such that the socket becomes rotatable relative to the anchor head.

[0064] In some applications, the crown and / or anchor head is shaped to define a free zone between the socket and the tissue-facing surface, and continuing to screw the anchor portion distally into the tissue includes continuing to screw the anchor portion distally into the tissue at least until the anchor head becomes pulled distally into the free zone.

[0065] In some applications, continuing to screw the anchor portion distally into the tissue includes continuing to screw the anchor portion distally into the tissue, at least until the anchor head becomes fully pulled into the free zone.

[0066] In some applications, the tissue anchor includes a spring disposed between the anchor head and the tissue-facing surface, and continuing to screw the anchor portion distally into the tissue includes continuing to screw the anchor portion distally into the tissue at least until the anchor head compresses the spring.

[0067] In some applications, continuing to screw the anchor portion distally into the tissue includes continuing to screw the anchor portion distally into the tissue, at least until the spring presses the tissue-facing surface against the tissue.

[0068] In some applications, the crown includes a slip clutch that is coupled to a drive interface and to an anchor head. Tightening the anchor portion distally into the tissue includes applying torque to the drive interface to twist the anchor portion distally into the tissue, such that the torque is transmitted from the drive interface to the anchor head via the slip clutch. Continuing to twist the anchor portion distally into the tissue includes continuing to twist the anchor portion distally into the tissue at least until the slip clutch is slipped at a torque threshold, causing the drive interface to rotate relative to the anchor head and the anchor portion.

[0069] In some applications, the anchor head is shaped to define a non-circular outer surface. The slip clutch includes a cantilever pin, the fixed portion of which is fixedly coupled to the actuator interface. Tightening the anchor portion distally into the tissue includes applying torque to the actuator interface to twist the anchor portion distally into the tissue, such that the actuator interface and the pin rotate together with the anchor head and the anchor portion about a longitudinal axis in a first rotational direction, while the torque-applying portion of the pin presses against the outer surface of the anchor head. In some embodiments, continuing to twist the anchor portion distally into the tissue includes continuing to twist the anchor portion distally into the tissue, at least until at a torque threshold, the slip clutch slides by deflecting the pin away from the longitudinal axis through the anchor head, causing the actuator interface to rotate relative to the anchor head and the anchor portion.

[0070] In some applications, the torque-applying portion of the pin is a first torque-applying portion of the pin. Tightening the anchoring portion distally into the tissue includes applying torque to the actuator interface to tighten the anchoring portion distally into the tissue, causing the actuator interface and the pin to rotate about the longitudinal axis in a first rotational direction, while the first torque-applying portion of the pin presses against the outer surface of the anchor head. In some embodiments, continuing to tighten the anchoring portion distally into the tissue includes continuing to tighten the anchoring portion distally into the tissue, at least until at a torque threshold, when the slip clutch slides by pushing against the first torque-applying portion through the anchor head, thereby deflecting the pin away from the longitudinal axis, causing the actuator interface to rotate relative to the anchor head and the anchoring portion.

[0071] In some applications, the method includes loosening the anchor portion proximally from the tissue by applying torque to the driver interface in a second rotational direction, such that the anchor head and the anchor portion rotate together with the driver interface in the second rotational direction, while the second torque-applying portion of the pin presses against the anchor head.

[0072] In some applications, the anchor head is shaped to define a notch, the pin defines a pawl serving as a second torque application portion, and loosening the anchor portion proximally from the tissue includes loosening the anchor portion proximally from the tissue by applying torque to the driver interface in a second rotational direction, such that the anchor head and the anchor portion rotate together with the driver interface in the second rotational direction while the pawl is latched into the notch.

[0073] In some applications, the method described herein further includes anchoring the implant, tether, and / or retraction member to tissue. Tissue anchors can be configured to anchor or secure the implant, tether, and / or retraction member to tissue. In some applications, tissue anchors are used to anchor or secure the implant, tether, and / or retraction member to tissue.

[0074] Anchoring or securing an implant, tether, and / or retractable member to tissue may include applying torque to the actuator interface to screw the anchor portion distally into the tissue, such that the actuator interface and the anchor portion rotate together about the longitudinal axis of the anchor, and continuing to screw the anchor portion distally into the tissue at least until the actuator interface becomes rotatable relative to the head of the anchor.

[0075] In some applications, after the implant, tether, and / or retraction member is anchored or secured to the tissue, the method further includes applying tension to the tether or retraction member to alter the shape and / or size of the tissue (e.g., altering the shape and / or size of the annulus of a heart valve, etc.).

[0076] The above-mentioned methods (one or more) can be performed on live animals or simulations (such as on a carcass, a carcass heart, a simulator (e.g., with simulated body parts, heart, tissues, etc.)).

[0077] The invention will be more fully understood from the following detailed description of its application, taken in conjunction with the accompanying drawings, wherein: Attached Figure Description

[0078] Figure 1A -E, 2A-H and 3A-H are schematic diagrams illustrating example organizational anchor systems and their use according to some applications;

[0079] Figure 4A -D, 5A-E, and 6A-B are schematic diagrams illustrating example organizational anchor systems according to some applications; and

[0080] Figure 7A -C, 8A-E, and 9A-C are schematic diagrams illustrating example organizational anchor systems based on some applications. Detailed Implementation

[0081] refer to Figure 1A -E, 2A-H, and 3A-H are schematic diagrams illustrating the use of the example organization anchor system 10 according to some applications.

[0082] System 10 includes a tissue anchor 12 and an anchor driver 40. As shown, the anchor 12 includes an anchor portion (i.e., a tissue engagement element) 34, which is shaped to facilitate screwing the anchor portion into tissue 90 by rotation about the longitudinal axis ax1 of the anchor 12. For example, as shown, the anchor portion 34 is shaped like a auger with a distal tissue puncture point 36. This does not preclude other shapes that facilitate screwing the anchor portion 34 into tissue 90. For example, the anchor portion may be shaped to define a threaded shank.

[0083] In some applications, as shown in the figure, the anchoring portion 34 is connected at the proximal portion of the anchoring portion to the crown 38 that defines the tissue-facing surface 28. Figure 1A -C is a side view showing the longitudinal cross-section of the crown 38 (but the anchoring portion 34 is shown in its entirety). Figure 1D This is a top view of anchor 12, specifically a top view of crown 38. Figure 1E yes Figure 1B The figure shows a cross-sectional view through the crown 38 at the indicated elevation. As shown, the crown 38 includes an anchor head 30 and a socket 24, which is shaped to receive the anchor head, for example, by means of the anchor head being reversibly placed within the socket. Figure 1B The anchor head 30, housed within the socket 24, is shown. Figure 1C The image shows the anchor head that has exited the bearing socket. For some such applications, such as... Figure 1E As shown in the cross-section, the shapes of the socket 24 and the anchor head 30 are complementary to each other, so that the socket receives the anchor head in a tight fit.

[0084] In some applications, as shown, the coronal portion 38 includes an actuator interface 41 coupled to the socket 24, such that the interface and the socket are rotatably fixed. An actuator 40 is configured to engage the actuator interface 41. In some applications, the actuator 40 is advanced transcavitally into the tissue 90 of a subject (e.g., tissue of the subject's heart), for example, when coupled to the anchor 12. In some such applications, the actuator 40 having a shaft 44 (e.g., a flexible shaft) facilitates transcavitative advancement of the actuator into the tissue 90.

[0085] In system 10, torque is indirectly transmitted from driver 40 to anchor head 30, for example, via driver interface 41 and bearing socket 24. For example, driver 40 may include driver head 45 located at the distal end of shaft 44, which is reversibly disposed within driver interface 41. Figure 1A For some applications, as shown in the figure, when the driver head 45 is positioned within the driver interface 41, the driver 40 (e.g., driver head 45) does not contact the anchor head 30. For example, because the anchor head is enclosed in the sleeve 20, the anchor head 30 may not be accessible to the driver head 45, as described below.

[0086] In some applications, the tissue-facing surface 28 is distally opposed to the bearing socket 24. In some applications, the tissue-facing surface 28 is axially fixed relative to the driver interface 41, such that screwing the tissue anchor 12 into the tissue 90 typically brings the surface 28 closer to the tissue (e.g., bringing the tissue-facing surface into contact with the tissue). In some applications, the tissue-facing surface 28 is also rotationally fixed relative to the driver interface 41 (e.g., the tissue-facing surface is fixedly attached to the driver interface 41).

[0087] For some applications, as shown in the figure, anchor 12 (e.g., its crown 38) includes a sleeve 20, which includes a socket 24, an interface 41, and a surface 28. The sleeve 20 can be a one-piece structure, shaped to define the socket 24, interface 41, and surface 28. The sleeve 20 can receive an anchor head 30, such that the crown 38 includes the anchor head and the sleeve that receives the anchor head. Typically, for such applications, the sleeve 20 is sized to define a free zone 25 within which the anchor head 30 is disposed, and the anchor head is not housed in the socket 24. Figure 1C The free zone 25 may be located at the distal end of the socket 24 (i.e., closer to the anchoring portion 34 than the socket 24). Although the socket 24 is configured to transmit torque from the interface 41 to the anchor head 30 when the anchor head is positioned in the socket (e.g., due to the tight fit between them), the free zone 25 is configured to allow the socket to rotate relative to the anchor head while the anchor head is positioned in the free zone and not in the socket (e.g., so that torque is not transmitted from the socket to the anchor head).

[0088] For some applications, the socket 24, interface 41, and surface 28 of sleeve 20 are rotated and fixed relative to each other, such that rotation of a portion of the sleeve causes rotation of the entire sleeve. This does not preclude applications where the tissue-facing surface 28, socket 24, and / or interface 41 are discrete components.

[0089] As described above, system 10 can be configured such that the drive 40 cannot access the anchor head 30 (e.g., its anchor head 45). For some applications, interface 41 (or another part of crown 38) defines a chassis 42 that separates the drive 40 from the anchor head 30 when the drive is positioned within the interface. Alternatively or additionally, the drive 40 (e.g., its drive head 45) is shaped to define one or more shoulders 46 (e.g., as shown in the image). Figure 1A (As shown, lateral positioning). Typically, for such applications, the shoulder 46 is sized such that when the drive interface 41 is engaged by the drive 40 (e.g., when the drive head 45 is positioned within the interface), the shoulder contacts the proximal surface 29 of the sleeve 20. The inaccessible anchor head 30 of the drive 40 facilitates the transmission of torque from the drive 40 to the drive interface 41 while reducing (e.g., eliminating) the direct transmission of thrust from the drive to the anchor head 30, for example, limiting any transmission of thrust via the sleeve 20.

[0090] In some applications, as shown in the figure, the anchor 12 can be in a first state (e.g., torque transmission state). Figure 1B ) and the second state (e.g., non-torque transmission state, Figure 1CThe transition between these states is as follows. In some applications, as shown, when anchor 12 is in the first state, anchor head 30 is positioned within socket 24. In this way, torque applied by actuator 40 to actuator interface 41 rotates socket 24, anchor head 30, and anchor portion 34. In some applications, as described below, the first state facilitates screwing anchor portion 34 into tissue 90.

[0091] Furthermore, in some applications, as shown in the figure, when the anchor 12 is in the second state, the anchor head 30 is positioned outside the socket 24 (e.g., away from the socket 24), such that the torque applied by the driver 40 to the driver interface 41 rotates the socket 24 relative to the anchor head 30 (and thus the anchoring portion 34), for example, so that the torque is not transmitted from the driver to the anchor head and the anchoring portion. The transition of the anchor 12 from the first state to the second state occurs in response to the anchor head 30 pulling the socket 24 distally by screwing the anchor into the structure 90, for example, as referenced below. Figure 2A -H as described.

[0092] For some applications, as shown in the figure, the anchor 12 further includes a compression spring 26, which may be disposed between the anchor head 30 and the tissue-facing surface 28 (e.g., within the sleeve 20). The function of the spring 26 will be described in more detail below.

[0093] Figure 2A -H shows that the actuator 40 is used to screw the anchor portion 34 of the anchor 12 into the tissue 90, while the anchor head 30 moves distally along the longitudinal axis ax1, thereby pressing the surface 28 against the tissue. Figure 3A -H shows the corresponding steps, but variant 12' of anchor 12 does not include the compression spring 26. This variant of anchor 12 will henceforth be referred to as anchor 12'.

[0094] Figure 2A An anchor 12 is shown positioned against tissue 90, such that the distal tissue puncture point 36 contacts the tissue. Torque is then applied from the driver head 45 via the interface 41 and the socket 24 to the anchor 12, thereby screwing the anchor portion 34 into the tissue 90. Figure 2B During this period, anchor 12 is in its torque-transmitting state and generally behaves similarly to existing one-piece structure anchors. Therefore, screwing the anchor portion 34 into the tissue 90 causes the tissue-facing surface 28 to move distally along the longitudinal axis until it contacts the tissue. Figure 2C ).

[0095] Figure 2D-F illustrates how the anchoring portion 34 is further screwed into the tissue 90 by the continued rotation of the driver head 45 and the crown 38, even though the anchoring portion is already screwed into the tissue 90 deep enough that the tissue resists further distal movement of the tissue-facing surface 28 and the socket 24 (typically the entire sleeve 20). Figure 2D As shown in -F, this resistance facilitates the transition of the anchor 12 from the first state to the second state because once the surface 28 contacts the tissue 90, further screwing of the anchor portion 34 into the tissue gradually pulls the anchor head 30 distally out of the socket 24, which is prevented from further distal advancement by the tissue 90. Since the resistance from the tissue 90 facilitates the transition of the anchor 12 to the second state, the torque applied to the actuator interface 41 is converted into distal movement of the anchor head 30 relative to the tissue-facing surface 28 (e.g., within the sleeve 20), rather than into a distal force exerted on the tissue 90 by the tissue-facing surface 28. Therefore, it is advantageous to assume that triggering the transition of the anchor 12 from the first state to the second state by the tissue 90 resisting further distal movement of the tissue-facing surface 28 can advantageously limit: (i) the distal force exerted on the tissue by the tissue-facing surface when the anchor is screwed into the tissue and / or (ii) the depth to which the anchor can be screwed into the tissue.

[0096] exist Figure 2D In -E, the anchor head 30 has moved further distally within the sleeve 20, but has not yet completely exited the socket 24 (e.g., the anchor head is partially disposed within the socket and partially disposed within the free zone). Therefore, torque transmission to the anchored portion 34 is still possible. Figure 2F When the anchor head 30 is fully pulled out of the socket 24 (i.e., into the free zone 25), the anchor 12 has changed to its non-torque transmission state, thereby rotating the socket away from the anchor head. Figure 2G The illustration shows further rotation of the actuator head 45, rotating the interface 41 and the socket 24 (e.g., the entire sleeve 20), but without causing further rotation of the anchor head 30 or further screwing the anchor portion 34 into the tissue. At this point where the anchor 12 is advanced into the tissue 90, the torque applied by the actuator 40 to the actuator interface 41 causes the socket 24 to rotate relative to the anchor head 30 and the anchor portion 34. Therefore, assuming that the anchor 12 changes from the first state to the second state in response to resistance from the tissue 90 to the tissue-facing surface 28, the risk of over-tightening or damage to the tissue in contact with the tissue-facing surface 28 is advantageously reduced.

[0097] At this point, the process of screwing the anchor 12 into the tissue 90 is usually complete, and the driver 40 can be removed. Figure 2H ).

[0098] As briefly described above, for some applications, as shown in the figure, the anchor 12 includes a compression spring 26 disposed within the sleeve 20 (e.g., within the free zone 25). In some such applications, the spring 26 helps to continuously screw the anchor 12 into the tissue 90 as the anchor transitions from a first state to a second state. The spring 26 may be disposed between the anchor head 30 and the tissue-facing surface 28. As the anchor head 30 is gradually pulled out of the socket 24, and before the anchor head is completely withdrawn from the socket, the anchor head contacts the spring 26. Figure 2E This further rotation of the anchor head 30 causes the spring to compress, pressing the tissue-facing surface 28 against the tissue 90. It is assumed that, for some applications, the spring 26 thereby advantageously increases the reliability of the anchor 12 because it increases the likelihood that the tissue-facing surface 28 will be firmly pressed against the tissue 90 before the anchor 12 transitions to its non-torque-transmitting state. For the convenience of the function of the spring 26, when the spring is in a relaxed state (e.g., before the anchor 12 is introduced into the subject's body), the axial height 50 of the anchor head 30 can be greater than the axial distance 52 between the socket 24 (e.g., its distal end) and the spring 26. In the non-torque-transmitting state of the anchor 12 (e.g., once the anchor 12 is screwed into the tissue 90), the combined axial height 54 of the anchor head 30 and the spring 26 can be similar to, but slightly smaller than, the axial distance 56 between the socket 24 (e.g., its distal end) and the distal end of the free zone 25. (For some applications, the axial distance 56 can be considered the axial height of the free zone 25.)

[0099] Figure 3A -H indicates the connection with Figure 2A -H is the same sequence, modified as necessary, but used for anchoring anchor 12'. Anchor 12' is generally the same as described for anchor 12, except that anchor 12' lacks spring 26, and can be sized differently to accommodate this lack of spring. The anchor head 30 is generally sized such that when the anchor head presses the tissue-facing surface 28 against the tissue 90, the anchor head retracts from the socket 24 ( Figure 3F This transforms the anchor 12' into its non-torque transmission state. Figure 3G ).

[0100] For some applications, in order to impart reliability to the anchor 12', for example, to reduce the possibility that the anchor 12' may transition to its non-torque-transmitting state before its tissue-facing surface 28 becomes firmly pressed against the tissue 90, the axial height 58 of the anchor head 30 may be similar to the axial distance 56, but not significantly less than the axial distance 56.

[0101] refer to Figure 4A-D, 5A-E, and 6A-B are schematic diagrams illustrating example organization of anchor systems 110 according to some applications. See also... Figure 7A -C, 8A-E, and 9A-C are schematic diagrams illustrating example organization anchor systems 210 according to some applications.

[0102] Systems 10, 110, and 210 share several features with each other. Furthermore, components with the same name across systems often have similar features and perform similar functions. For example, each of the organization anchors 112 and 212 includes drive interfaces 141 and 241, which are engaged by drive heads 45 and rotated using a drive 40. Therefore, the following description of systems 110 and 210 focuses on the features that distinguish each system from system 10.

[0103] Systems 110 and 210 are described as including anchor driver 40 (described above with reference to Figures 2 and 3A-H), but each of these systems may optionally include a different anchor driver.

[0104] For some applications, such as Figure 4A and 7A As shown, each crown 138, 238 includes a respective housing 119, 219, which includes a proximal sleeve 124, 224 and a distal sleeve 126, 226. A plurality of recesses 123, 223 (e.g., recesses 123a and 123b, or recesses 223a and 223b, respectively) are shown defined by the distal sleeve 126, 226; however, these recesses may optionally be defined by the proximal sleeve 124 with necessary modifications.

[0105] Each of the crown portions 138 and 238 further includes an anchor head 130, 230 that is fixedly connected to an anchor portion 134, 234 via a neck 132, 232, the anchor portion 134, 234 having a distal tissue puncture point 136, 236 such that rotation of the anchor head causes the anchor portion to rotate about longitudinal axes ax10, ax20, as described above with reference to anchor 12.

[0106] The crowns 138 and 238 of anchors 112 and 212 do not utilize a bearing socket in the manner described for crown 38 of anchor 12. Instead, each of crowns 138 and 238 includes elements that together serve as slip clutches 140 and 240, which engage (e.g., selectively rotatably engage) their respective drive interfaces 141 and 241 to their respective anchor heads 130 and 230.

[0107] Selectively rotatably connecting interfaces 141 and 241 to anchor heads 130 and 230 via slip clutches 140 and 240 facilitates torque transmission from the driver interface to the anchor head, but limits the transmitted torque so that it does not exceed a torque threshold. It is assumed that using slip clutches to limit the transmitted torque reduces the risk of overtightening the anchor or damaging tissue. Further, it is hypothesized that, for some applications, using slip clutches in this manner can also reduce the risk of undertightening the anchor by enabling surgeons to confidently tighten it without unintentionally overtightening it.

[0108] like Figure 4A As shown in -D, the slip clutch 140 defined by the crown 138 of the tissue anchor 112 includes one or more cantilever pins 122 (e.g., a first cantilever pin 122a along a first groove axis ax5a and a second cantilever pin 122b along a second groove axis ax5b) such that each pin is disposed within a corresponding groove 123 defined by the housing 119. Figure 5A As shown, the groove 123 includes a loose portion 135 in which a free portion 145 of the pin 122 is disposed, and a fastening portion 133 in which a fixing portion 143 of the pin is disposed (e.g., such that the fixing portion is fixedly connected to the driver interface 141). The width d2 of the loose portion can be greater than the width d1 of the fastening portion.

[0109] In some applications, such as Figure 5A As shown, each groove axis ax5 lies on a groove plane that is approximately perpendicular to the longitudinal axis ax1 and longitudinally aligned with the anchor head 130. In this manner, each pin 122 is longitudinally aligned with the anchor head 130. In the cross-section (e.g., Figure 5A In the anchor head 130, a non-circular profile defines a plurality of outer surfaces (e.g., sides) 144. Although the anchor head 130 is shown as having a square profile, this does not preclude other shapes (e.g., other polygons, such as hexagons). In the stationary state of the anchor 112 (e.g., as...), Figure 4B and 4D As shown), each pin 122 contacts the outer side 144 of the anchor head 130.

[0110] In some applications, as shown, the anchor head 130 is coupled to a bearing 120 housed within a housing 119, such that the bearing is rotatably coupled to the housing, and rotatably coupled the anchor head and anchor portion 134 to the housing. In some applications, the bearing 120 is tightly housed within the housing 119 to provide smooth rotation with minimal wobble. In this way, rotation of the drive interface 141 causes rotation of the housing 119; however, whether rotation of the housing causes rotation of the bearing 120, anchor head 130, and anchor portion 134 depends on the contact between the cantilever pin 122 (e.g., its outer surface 144) and the anchor head (i.e., on the slip clutch 140).

[0111] In some applications, the rotational connection from the drive interface 141 to the anchor head 130 is achieved via contact between the cantilever pin 122 and the anchor head, for example, by the cantilever pin pressing against the outer surface 144 of the anchor head. For example, as described in more detail below, the system can be configured such that applying a torque below a torque threshold to the interface 141 causes the housing 119, pin 122, and anchor head 130 to rotate uniformly, while the pin remains in contact with the outer surface 144 of the anchor head. However, applying a torque above the torque threshold typically causes the anchor head to push against the pin, causing the pin to deflect laterally away from the longitudinal axis ax10, while the pin (and housing 119) rotates about the anchor head. In this way, torque exceeding the torque threshold may not be transmitted to the anchor head 130.

[0112] For some applications, such as Figure 5A As shown, torque is transmitted from a portion of pin 122, for example, from a torque-applying portion 142 (e.g., a first torque-applying portion 142a) between the fixed portion 143 and the free portion 145, to the outer surface 144 of the anchor head 130, which contacts the outer surface of the anchor head. In some such applications, when the anchor portion 134 is screwed into the tissue 90, the torque-applying portion 142 includes the front end of pin 122 such that the torque-applying portion rotates in front of the fixed portion 143, while pin 122 rotates about axis ax10.

[0113] For some applications, as shown in the figure, the torque application portion 142 is defined only by being part of the pin 122 through which torque is applied to the anchor head 130, rather than by any physical or other distinguishing feature of that portion as the pin.

[0114] Figure 5A The rotating arrow in the diagram indicates that the torque applied to the driver interface 141 by the driver 40 causes the housing 119, the anchor head 130, and the anchor portion 134 to rotate together with the pin 122, thereby facilitating the screwing of the anchor 112 into the tissue 90.

[0115] Figure 5B It is shown that the anchor 112 has been screwed into the tissue 90 due to the continuous application of torque to the anchor interface 141 in a first direction (e.g., a positive torque applied in the positive direction). Screwing the anchor 112 into the tissue 90 has moved the anchor distally, causing the tissue-facing surface 128 to contact the tissue. At this point, the resistance provided by the tissue to further distal movement of the tissue-facing surface 128 increases the magnitude of the torque required to continue rotating the actuator interface 141 above a torque threshold (e.g., increasing the required torque from a first magnitude below the torque threshold to a second magnitude above the torque threshold).

[0116] like Figure 5C As shown, the anchor head 130 (e.g., its outer surface 144) begins to deflect the pin 122 away from the longitudinal axis ax10, so that the pin is not completely parallel to the groove axis ax5, and the slip clutch 140 begins to slip.

[0117] In some applications, when torque is applied to interface 141 above a torque threshold, pin 122 has sufficient flexibility to deflect, and the torque-applying portion 142a contacts the anchor head 130 at one end of the cantilever span (e.g., forward cantilever span d3), while the retaining portion 143 of the pin is fitted within the fastening portion 133 at the other end of the cantilever span. Therefore, the forward cantilever span is typically measured along the pin from (i) the torque-applying portion 142a to (ii) the retaining portion 143. The flexibility of pin 122 and / or the length of the forward cantilever span d3 can be configured to set the torque threshold of the slip clutch 140.

[0118] Figure 5D The diagram shows that as the slip clutch 140 continues to slide, pin 122 deflects further away from the longitudinal axis ax1, and as the free portion 145 of the pin pivots within the loose portion 135 of the groove 123, the pin-to-pin distance d5 between the corresponding contact point of pin 122 and the anchor head increases. At this stage, pin 122 has begun to slide (i.e., rotate) about the anchor head 130, such that continued application of a second magnitude of torque causes the drive interface 141 to rotate relative to the anchor head and the anchor portion 134—that is, to rotate without further screwing the anchor portion into the tissue.

[0119] like Figure 5E As shown, further rotation of interface 141 allows pin 122 to deflect toward the center of its original configuration, and the pin-to-pin distance d5 decreases because the interface and pins, from their original positions... Figure 5B The orientation shown has completed a quarter of a circle.

[0120] In some cases, it may be necessary to remove the tissue anchor 112 from the tissue 90 (e.g., after the tissue anchor has been partially or completely screwed into the tissue). For example, the surgeon may choose to move the anchor (e.g., to an alternative portion of the implant, and / or to an alternative location in the tissue) or remove the anchor completely (e.g., because the anchor is no longer needed).

[0121] like Figure 6A As shown in -B, the removal of the anchor 112 from the tissue 90 is achieved by applying a reverse torque (i.e., a torque in a second rotational direction opposite to the first rotational direction) to the interface 141, such that the pin 122 rotates about the longitudinal axis ax10 in the second rotational direction while the pin contacts the outer side 144 of the anchor head.

[0122] For some applications, while the initial anchoring torque is limited, it may be important to ensure that sufficient counter-torque can be applied to loosen the anchor. Furthermore, in some cases, surgeons may encounter greater resistance when loosening anchor 121 than when initially screwing it into tissue 90. For example, scar tissue development at the implantation site of anchor 121 may hinder anchor removal. To facilitate loosening of anchor 112 from tissue 90, some applications of tissue anchor 112 allow a counter-torque greater than the forward torque to be transmitted from driver interface 141 to anchor head 130.

[0123] Therefore, for some such applications, a reverse torque exceeding a torque threshold (e.g., at a second magnitude) can be transmitted from the driver interface 141 to the anchor head 130. That is, when a reverse torque of the second magnitude is applied to the interface 141, the pin 122 has sufficient rigidity to resist deflection, and the torque-applying portion 142b contacts the anchor head 130 at one end of the reverse cantilever span d4, while the pin's retaining portion 143 is fitted within the fastening portion 133 at the other end of the reverse cantilever span. For some such applications, when the anchoring portion 134 is loosened from the organization 90, the torque-applying portion 142, including the tip of the pin 122, rotates in front of the retaining portion 143, while the pin rotates about axis ax10.

[0124] As shown in the figure, the reverse cantilever span is typically measured along the pin from (i) the torque application portion 142b to (ii) the fixing portion 143. The reverse cantilever span d4 is typically shorter than the forward cantilever span d3, such that when the anchor 112 is loosened, the torque application portion 142b is closer to the fixing portion 143 than when the anchor is screwed into the tissue 90. It is assumed that the magnitude of the torque that can be applied from the anchoring interface 141 to the anchor head 130 via the pin 122 is inversely proportional to the length of the cantilever span, thus allowing a larger torque to be transmitted along the shorter cantilever span.

[0125] However, it may also be necessary to limit the magnitude of the applicable reverse torque. Therefore, for some applications, the slip clutch 140 limits the magnitude of the reverse torque that can be applied from the interface 141 to the anchor head 130 when loosening the anchor 112. For such applications, a second torque threshold (i.e., a reverse torque threshold) greater than the first torque threshold is typically established. Therefore, applying torque at a third magnitude exceeding the second torque threshold causes the slip clutch 140 to slip, and the drive interface 141 to rotate relative to the anchor head 130 and the anchor portion 134.

[0126] Refer again Figure 7A -C, 8A-E, and 9A-C illustrate the tissue anchor 212 of system 210. As described above, tissue anchor 212 shares features with tissue anchor 112. Therefore, the following description focuses on the features that distinguish anchor 212 from anchor 112, and in particular the features of slip clutch 240, which differ from those of slip clutch 140. For example, slip clutch 240 includes a gear 230 replacing anchor head 130 and a cantilever pin 222 replacing pin 122. Thus, slip clutch 240 is a ratchet slip clutch, wherein pin 222 defines a pawl that interacts with gear 230, as described in more detail below.

[0127] Similar to slip clutch 140, slip clutch 240 helps to transfer torque from the drive interface to the anchor head, but by selectively rotatably connecting drive interface 241 to gear 230, it limits the amount of torque that can be applied when the tissue anchor 212 is screwed into the tissue 90.

[0128] The groove 223 is sized to fit snugly with the pin 222, similar to the fit between the fastening portion 133 and the pin 122, and the pin 222 is typically sized such that when its fixing portion 243 is positioned within the groove 223, the pin (e.g., its torque application portion 242) contacts the gear 230 (e.g., its non-circular outer surface 244). In the stationary state of the anchor 212 (e.g., as...), Figure 7B and 7C As shown), each pin 222 contacts the outer surface 244 of the gear 230.

[0129] For some applications, and similar to the anchor head 130 of reference system 110 above, gear 230 is coupled to bearing 220 housed within housing 219, such that bearing is rotatably coupled to housing, and gear and anchor portion 234 are rotatably coupled to housing. For some applications, bearing 220 is tightly housed within housing 219 to provide smooth rotation with minimal wobble. In this way, rotation of drive interface 241 causes housing 219 to rotate; however, whether rotation of the sleeve will cause bearing 220, gear 230, and anchor portion 234 to rotate depends on the contact between pin 222 (e.g., its outer surface 244) and gear.

[0130] Figure 8A The anchor 212 is shown being screwed into the tissue 90. Figure 8A The rotating arrow indicates that the torque applied to the drive interface 241 by the drive 40 causes the housing 219, gear 230, and anchor portion 234 to rotate, thereby screwing the anchor portion 230 into the tissue 90. Similar to the description above with reference to the slipper clutch 140, when the torque is applied to the interface 241 below the torque threshold, the pin 222 rotates about the longitudinal axis ax20, and the torque-applying portion 242a of the pin contacts the outer surface 244 of the gear 230, thereby causing the gear and the anchor portion 234 to rotate. However, contrary to the description above with reference to the slipper clutch 140, when the anchor portion 234 is screwed into the tissue 90, the retaining portion 243 includes the front end of the pin 222, such that the retaining portion rotates in front of the torque-applying portion 242, while the pin rotates about the axis ax20.

[0131] Figure 8B It is shown that the anchor 212 has been screwed into the tissue 90 due to the continuous application of a positive torque to the anchor interface 241. Screwing the anchor 212 into the tissue 90 has caused the anchor to move distally, such that the tissue-facing surface 228 contacts the tissue. As described above with reference to the tissue anchor 121, the resistance provided by the tissue to further distal movement of the tissue-facing surface 228 increases the magnitude of the torque required for the rotary actuator interface 241 (e.g., from a first magnitude to a second magnitude) to exceed a torque threshold.

[0132] like Figure 8C As shown, gear 230 (e.g., its outer surface 244) begins to laterally deflect the torque-applying portion 242a of pin 222 away from the longitudinal axis ax20, so that the pin is not completely parallel to the axis ax5. Pin 222 begins to slide around gear 230, thereby reducing the torque transmitted from driver interface 241 to gear 230. Figure 8DGear 230 is shown, having a pin 222 (e.g., its torque application portion 242a) further deflected away from the longitudinal axis ax20, causing the slip clutch 240 to continue sliding around gear 230. At this stage, a second magnitude of positive torque is applied, causing the drive interface 241 and pin 222 to rotate relative to gear 230 and anchoring portion 234.

[0133] like Figure 8E As shown, further rotation of interface 241 allows pin 222 to deflect toward the center of its original configuration, because the interface and pin, from their respective positions... Figure 8B The orientation shown has completed a quarter of a circle.

[0134] Similar to the reference above Figure 6A -B The tissue anchor 112 described herein may need to be removed from tissue 90 in certain circumstances (e.g., after the tissue anchor has been partially or fully screwed into the tissue).

[0135] like Figure 9A As shown in -B, the anchor 212 is removed from the tissue 90 by applying a reverse torque to the interface 241, causing the pin 222 to rotate about the longitudinal axis ax20 in the second rotational direction, while the pin contacts the gear 230.

[0136] However, when rotating in the second rotational direction about the longitudinal axis ax20, the way the pin 222 of the anchor 212 contacts the gear 230 is different from the way the pin contacts the gear when rotating in the first direction. For example... Figure 9B As shown, reverse rotation of the driver interface 241 can cause pin 222 to rotate in the opposite direction relative to gear 230 (e.g., "backlash"). As shown, the degree of backlash allowed by the reverse rotation of pin 222 is typically limited to less than a quarter turn.

[0137] Figure 9B It is shown that pin 222 has rotated in the second direction until the pin engages gear 230 (e.g., until end 248 is latched into recess 246). In some applications, once end 248 is fitted into recess 246, backlash stops, and pin (e.g., torque application portion 242b) transmits torque from interface 241 to gear 230, this time in the second direction.

[0138] Therefore, the slipper clutch 240 allows reverse torque exceeding the torque threshold to be transmitted from the drive interface 241 to the gear 230. For example... Figure 9B As shown in -C, in response to the pin 222 rotating about the longitudinal axis ax20 in the second direction, rotating together with the drive interface 241 via the gear 230 and the anchor portion 234, latching the end 248 of the pin 222 into the notch 246 helps to unscrew the anchor 212 from the tissue 90.

[0139] Refer again Figure 1A-9C The tissue anchors described herein can be used to secure one tissue to another, and / or to attach another element (e.g., an implant) to a tissue. For example, a system for treating a patient may include an implant secured to a tissue using any of the tissue anchors described herein.

[0140] The tissue anchors described herein can be used to anchor to cardiac tissue, such as the atrial wall, ventricular wall, or valvular annulus. For some applications, one or more tissue anchors described herein can be used to secure an implant to cardiac tissue. For some applications, one or more tissue anchors described herein can be used to secure a tether or compression member (e.g., a compression suture, compression band, compression suture, etc.) to cardiac tissue, which will be tightened to alter the shape and / or function of the heart. For example, one or more tissue anchors described herein can be used to secure a tether or compression member to ventricular tissue, which is also secured to a valvular leaflet. For some applications, the various tissue anchors described herein can be used to secure annular angioplasty structures to the valve annulus, for example, using anchors that replace the anchors described in one or more embodiments disclosed in the following patent applications: U.S. Patent 9,949,828 to Sheps et al., U.S. Patent Application Publication 2020 / 0015971 to Brauon et al., PCT Application PCT / IB2020 / 060044 to Kasher et al., and / or U.S. Provisional Patent Application 63 / 147,699 to Shafigh et al., each of which is incorporated herein by reference. Furthermore, one or more features of the tissue anchors described in these incorporated references can be incorporated into any of the tissue anchors described above. For example, the scope of this disclosure includes modifications to any of the anchors described above to include (e.g., on the coronal portion of the tissue anchor) eyelets or rotation eyelets, such as those described in one of these incorporated references, to allow the anchor to be slidably coupled to a tether or compression member that will anchor the annulus around the heart valve and subsequently tensioned to perform endovascular valvuloplasty. For some applications, implants include tether / contraction components and one or more anchors as described herein.

[0141] This invention is not limited to what is specifically shown and described herein. Rather, the scope of this invention includes combinations and sub-combinations of the various features described herein, as well as variations and modifications that would occur to those skilled in the art upon reading the foregoing description and not found in the prior art. Furthermore, the treatment techniques, methods, operations, procedures, etc., described or suggested herein can be performed on living animals or non-living simulations, such as on cadavers, cadaver hearts, simulators (e.g., with simulated body parts, tissues, etc.).

Claims

1. A system for tissue of a subject, the system comprising: drive; as well as Tissue anchors, the tissue anchors comprising: An anchoring portion, said anchoring portion being configured to screw distally into the tissue by rotating about the longitudinal axis of said anchor; and A crown portion, said crown portion being coupled to the proximal portion of said anchoring portion, defining a surface facing the tissue, and comprising: An anchor head, which is fixedly connected to the anchor portion, such that screwing the anchor portion into the tissue causes the anchor head to move distally toward the tissue along the longitudinal axis. A driver interface, the driver interface being configured to engage with the driver, and A socket, which is fixedly connected to the driver interface and is shaped to receive the anchor head within the socket, wherein the tissue-facing surface faces distally away from the socket. The tissue anchor has the following characteristics: In the first state, the anchor head is tightly seated within the socket, such that the torque applied by the actuator to the actuator interface rotates the socket, the anchor head, and the anchor portion, thereby facilitating the screwing of the anchor portion into the tissue. In the second state, the anchor head is positioned distal to the bearing socket, such that the torque applied by the driver to the driver interface rotates the bearing socket relative to the anchor head and the anchor portion. The tissue anchor is configured to transition from the first state to the second state in response to the anchor portion being screwed into the tissue sufficiently deep, such that the tissue resists further distal movement of the tissue-facing surface, while the screwing of the anchor portion into the tissue pulls the anchor head distally out of the socket.

2. The system according to claim 1, wherein, The driver interface defines a chassis that separates the driver from the anchor head when the driver engages the driver interface.

3. The system according to claim 1, wherein, The anchor head is shaped such that the cross-section of the anchor head defines a non-circular profile.

4. The system according to claim 3, wherein, The anchor head is shaped such that the cross-section of the anchor head defines a plurality of outer sides.

5. The system according to claim 3, wherein, The anchor head is shaped such that the cross-section of the anchor head defines a polygon.

6. The system according to claim 5, wherein, The polygon is at least one of a square and a hexagon.

7. The system according to any one of claims 1 to 6, wherein, The tissue is tissue of the subject's heart, and the tissue anchor is capable of being advanced into the heart via a cavity.

8. The system according to claim 7, wherein, The actuator includes a flexible shaft and an actuator head located at the distal end of the shaft, enabling the actuator to be advanced transcavitally into the heart.

9. The system according to any one of claims 1 to 6, wherein, The crown portion includes a sleeve, the size of which is defined as follows: The driver interface The socket, The surface facing the organization, and The free zone is provided between the socket and the tissue-facing surface. When the anchor is in the second state, the head of the anchor is positioned within the free zone.

10. The system according to claim 9, wherein, When the anchor head is positioned in the free zone, the anchor head is able to rotate relative to the bearing socket.

11. The system according to claim 9, wherein, The actuator includes an actuator head, the actuator head being shaped to define a shoulder, the shoulder being: Located on one side of the driver head, and Its dimensions are set such that when the driver interface is engaged by the driver head, the shoulder contacts the proximal surface of the sleeve.

12. The system of claim 9, further comprising a spring disposed within the sleeve, between the anchor head and the tissue-facing surface, wherein, The anchor is configured such that when the anchor transitions from the first state to the second state: The anchoring portion is screwed into the tissue, and the head of the anchor is pulled distally out of the socket, thereby compressing the spring.

13. The system according to claim 12, wherein, The anchor is configured such that when the anchor changes from the first state to the second state, screwing the anchor portion into the tissue pulls the anchor head distally out of the socket, thereby compressing the spring and pressing the tissue-facing surface against the tissue.

14. The system according to claim 12, wherein, The anchor is configured such that when the anchor changes from the first state to the second state, screwing the anchor portion into the tissue pulls the anchor head distally out of the socket, thereby compressing the spring when the anchor head is in the following state: Partially disposed within the socket, and It is partially located within the free zone.

15. The system according to any one of claims 1 to 6, further comprising an implant, wherein, The tissue anchor is configured to secure the implant to the tissue.

16. The system according to claim 15, wherein, The implant includes a tether or retraction member, wherein the tissue anchor is configured to secure the tether or retraction member to the tissue such that applying tension to the tether or retraction member alters the shape and / or size of the tissue.

17. A system comprising: Tissue anchors, the tissue anchors comprising: An anchoring portion, the anchoring portion being configured to rotate about the longitudinal axis of the anchor; and An anchor head, which is fixedly connected to the anchor portion, such that rotating the anchor portion into the tissue causes the anchor head to move distally toward the tissue along the longitudinal axis. A socket, the socket being shaped to receive the head of the anchor within the socket. The tissue anchor has the following characteristics: In the first state, the anchor head is tightly seated within the socket, such that the torque applied to the tissue anchor by the actuator rotates the socket, the anchor head, and the anchoring portion, thereby facilitating the screwing of the anchoring portion into the tissue. In the second state, the anchor head is positioned distal to the socket, such that the torque applied to the tissue anchor by the actuator rotates the socket relative to the anchor head and the anchor portion.

18. The system according to claim 17, wherein, The tissue anchor is configured to transition from the first state to the second state in response to the anchor portion being screwed into the tissue deep enough that the tissue pulls the anchor head distally out of the socket to resist further rotation.

19. The system according to any one of claims 17 to 18, wherein, The tissue anchor includes a crown portion connected to the proximal portion of the anchor portion, the crown portion defining a tissue-facing surface distally away from the socket.

20. The system according to any one of claims 17 to 19, wherein, The tissue anchor includes a driver interface that can be engaged by the driver and is configured to allow the driver to apply torque to the tissue anchor.

21. The system according to claim 20, wherein, The driver interface defines a chassis that separates the driver from the anchor head when the driver engages the driver interface.

22. The system according to any one of claims 17 to 21, wherein, The crown portion of the tissue anchor includes a sleeve, the size of which is defined as follows: Driver interface, The socket, The surface facing the organization, and The free zone is provided between the socket and the tissue-facing surface. When the anchor is in the second state, the head of the anchor is positioned within the free zone.

23. The system of claim 22, further comprising a spring disposed within the sleeve between the anchor head and the tissue-facing surface, wherein, The anchor is configured such that when the anchor transitions from the first state to the second state: The anchoring portion is screwed into the tissue, and the head of the anchor is pulled distally out of the socket, thereby compressing the spring.

24. The system according to any one of claims 17 to 23, further comprising an implant, wherein, The tissue anchor is configured to secure the implant to the tissue.

25. The system according to claim 24, wherein, The implant includes a tether or retraction member, wherein the tissue anchor is configured to secure the tether or retraction member to the tissue such that applying tension to the tether or retraction member alters the shape and / or size of the tissue.

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