Catheter ultrasound device and method for assessing target tissue

Abstract

To provide a catheter ultrasound device for assessing a target tissue.SOLUTION: An implant includes a wall (28) surrounding a lumen. A delivery tool includes a catheter (22), a control assembly, and an ultrasound tool. The catheter is transluminally advanceable into a subject and has a distal opening. The implant may be delivered via a catheter. The control assembly is capable of advancing at least a portion (70) of the wall out of the distal opening and steering the catheter to place the portion against a site of tissue of a subject. The section is disposed distally from the portion and opposite the distal opening. The ultrasound tool may facilitate imaging of the site by (i) positioning an ultrasound transceiver within the lumen and facing the portion, and (ii) transmitting ultrasound energy through the portion.SELECTED DRAWING: Figure 2E

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims priority to U.S. Provisional Patent Application No. 62 / 959,837 to Sharon et al., entitled "Catheter Ultrasound Devices and Methods for Assessing Targeted Tissue," filed January 10, 2020. This provisional patent application is incorporated herein by reference. [Background technology]

[0002] Heart valve annular dilation, caused for example by ischemic heart disease, prevents the leaflets from fully coapting when the valve closes. Backflow of blood from the ventricles into the atria results in elevated stroke volume and reduced cardiac output, ultimately leading to ventricular weakness secondary to atrial volume and pressure overload. Summary of the Invention [Means for solving the problem]

[0003] This summary is intended to present some examples and is not intended to limit the scope of the present invention. For example, any features included in the examples of this summary are not essential to the claims unless those features are explicitly recited in the claims. Also, features, components, steps, and concepts described in this summary and in examples elsewhere in this disclosure can be combined in various ways. Various features and steps described elsewhere in this disclosure may be included in the examples outlined in this section.

[0004] Described herein are example devices, systems, techniques, methods, etc. for implanting an implant into the tissue of a subject.

[0005] In some applications, an external control assembly is used to steer the distal portion of the catheter so that its distal opening is disposed on an opposite side of a tissue site. In some applications, a portion of the implant wall can be positioned on an opposite side of the site, and an ultrasound tool can be used to assess the site of tissue, for example, by transmitting ultrasound energy through the portion of the wall to the site and detecting ultrasound energy reflected from the site.

[0006] In some applications, an anchor driver may be used to anchor the implant to tissue by driving a tissue anchor through the aforementioned portion of the wall and into the aforementioned site of tissue.

[0007] For some applications, some embodiments include an anchor channel defining a longitudinal cavity and a distal region including a distal aperture. An anchor driver coupled to a tissue anchor can be advanced distally through the longitudinal cavity to the implant with the distal region disposed within the implant and the distal aperture disposed in the leading portion of the wall. For example, the leading portion of the wall can be anchored against the leading portion of the tissue using the anchor channel to hold the leading portion of the wall in abutment against the leading portion of the tissue.

[0008] For some applications, some aspects include positioning an ultrasonic transmitter / receiver of an ultrasonic tool within the lumen of the implant and facing the aforementioned portion of the wall.

[0009] For example, the ultrasonic transmitter / receiver can be shaped as a ring that defines a passage therethrough. A tissue anchor can be advanced through the passage while coupled to the anchor driver to reach the aforementioned portion of the wall. In this manner, the anchor driver can be advanced through the passage through the cavity while the ultrasonic transmitter / receiver remains within the lumen of the implant.

[0010] Optionally, the anchor driver and ultrasonic tool can be sized so that only one of the anchor driver or the ultrasonic tool can be disposed within the longitudinal cavity at a given time. In such applications, the anchor driver can be configured to be advanceable through the longitudinal cavity to the implant only if the ultrasonic tool is not disposed through the longitudinal cavity, and thus the ultrasonic tool and anchor driver can be alternately advanced and withdrawn to assess and then anchor to the tissue site. In some such applications, the anchor channel is used to hold the preceding portion of the wall against the preceding site of tissue during withdrawal of the ultrasonic tool from the cavity and subsequent advancement of the anchor driver through the cavity to the implant.

[0011] In some applications, two or more anchors are used to anchor two or more corresponding portions of the implant wall to two or more corresponding regions of tissue, and in some such applications, ultrasound-based assessment is performed for each of these regions.

[0012] For some applications, aspects include using a connector to relay data representing reflected ultrasonic energy detected by the ultrasonic transceiver from the ultrasonic transceiver to an ultrasonic controller, which can be used to analyze this data.

[0013] For some applications, the tissue may include tissue of a heart annulus, and the implant may include an annuloplasty structure. For some applications, anchoring the implant to the tissue may include anchoring a portion of a wall of the annuloplasty structure to the tissue of the annulus. For some such applications, the annuloplasty structure may include a contraction member (e.g., a contraction wire, contraction line, etc.) extending along a sleeve of the annuloplasty structure, and the adjustment mechanism of the annuloplasty structure may be configured to contract the sleeve by applying tension to the contraction member.

[0014] In some applications, the implant and / or annuloplasty structure may be a design without a wall or inner lumen or a sleeveless design, for example, the implant and / or annuloplasty structure may comprise a contraction member (e.g., a contraction wire, contraction line, etc.) connected to (e.g., threaded through) multiple anchors and / or may consist of a contraction portion.

[0015] For some applications, aspects include placing an indicator wire within a blood vessel of a subject's heart and generating a physical field about the indicator wire by passing an electric current through the indicator wire. For example, the physical field can include an electrostatic field, an electromagnetic field, an electric field, or a magnetic field.

[0016] For some applications, aspects include using an anchor delivery system to deliver a tissue anchor toward a portion of tissue adjacent to a blood vessel. Often, the anchor delivery system includes a sensing element in a portion of the anchor delivery system. For some applications, the sensing element is used to determine a position of a portion of the anchor delivery system by placing the portion within range of an indicator wire. For example, the position of the portion can be determined by measuring a change in a physical field.

[0017] For some applications, aspects include placing an indicator wire within a vessel of the subject's heart and generating an ultrasound field using an ultrasound sensing element by positioning the portion of the anchor delivery system within range of the indicator wire. For example, the anchor delivery system can include an ultrasound sensing element on a portion of the anchor delivery system. In some such applications, this position of the portion can be determined by measuring changes in the ultrasound field.

[0018] For some applications, aspects include calculating a distance between the portion of the anchor delivery system and a portion of the indicator wire. For example, calculating the distance can include comparing the distance to a predetermined threshold.

[0019] For some applications, aspects include moving the portion of the anchor delivery system through a lumen of the annuloplasty structure and deploying a tissue anchor from within the lumen of the annuloplasty structure into the portion of tissue, For example, the tissue anchor may be deployed into the site of tissue in response to comparing the distance to a predetermined threshold.

[0020] Thus, according to one application, a system and / or device for use with tissue of a subject is provided. The system and / or device includes an implant and a delivery tool. For some applications, the implant includes a contraction member (e.g., a contraction wire, contraction line, etc.) connected to (e.g., threaded through, directly connected to, operatively connected / coupled to, etc.) the multiple anchors. For some applications, the implant includes a wall surrounding a lumen. For some applications, the implant does not include a lumen and / or a wall.

[0021] The delivery tool includes a catheter transluminally advanceable to the tissue and having a distal portion with a distal opening. The implant can be configured to be delivered to the tissue via the catheter. The delivery tool also includes an extracorporeal control assembly. The control assembly can be configured to advance at least a portion of the implant (e.g., a portion of the wall, a length of the implant, a portion of the contraction member, and an anchor, etc.) out of the distal opening. The control assembly can also be operably coupled to the distal portion to steer the distal portion to position the portion of the implant (e.g., the wall portion and the length of the implant, etc.) in abutment against a site of the tissue, the site being disposed distally from the portion of the implant (e.g., the wall portion and the length of the implant, etc.) and on the opposite side of the distal opening.

[0022] For some applications, the delivery tool further includes an ultrasonic tool. The ultrasonic tool is advanceable within the catheter and can include an ultrasonic transmitter / receiver at a distal end. For some applications, the ultrasonic tool is configured to facilitate imaging of the site by positioning the ultrasonic transmitter / receiver facing the preceding portion of the implant and transmitting ultrasonic energy through the preceding portion of the implant and into the site. For some applications, if the preceding portion of the implant is a portion of a wall of the implant having a lumen, the ultrasonic tool is configured to be located within the lumen of the implant and position the ultrasonic transmitter / receiver facing the preceding portion of the wall of the implant and transmitting ultrasonic energy through this portion of the wall (e.g., from within the lumen) and into the site to facilitate imaging of the site.

[0023] The system and / or device may further include a tissue anchor and an anchor driver configured to drive the tissue anchor through said portion of the wall and into said site, thereby anchoring the implant to the tissue.

[0024] In one application, the catheter is configured to be advanceable transfemorally and transseptally into the tissue.

[0025] In one application, the distal portion of the catheter is radiopaque.

[0026] For one application, the anchor driver is configured to advance a tissue anchor through the catheter to the implant, with the implant being disposed in tissue.

[0027] In one application, the ultrasonic transceiver is configured to detect reflected ultrasonic energy, the reflected ultrasonic energy being a portion of the ultrasonic energy transmitted by the ultrasonic transceiver and reflected from the site. The ultrasonic tool can include an ultrasonic controller having circuitry and a user interface. The ultrasonic controller is configured to facilitate analysis of the reflected ultrasonic energy detected by the ultrasonic transceiver. The ultrasonic tool can include a connector configured to relay data representing the reflected ultrasonic energy detected by the ultrasonic transceiver from the ultrasonic transceiver to the ultrasonic controller.

[0028] For one application, the ultrasonic transceiver is configured to detect reflected ultrasonic energy reflected from the site through the portion of the wall.

[0029] For one application, the delivery tool includes an anchor channel defining a longitudinal cavity terminating in a distal aperture. The anchor channel can extend through the catheter such that a distal region of the anchor channel is disposed at a forward portion of the implant (e.g., within the lumen of the implant, against the side of the implant, adjacent to the implant, etc.). For some applications, the distal region includes the distal aperture. For some applications, the anchor channel is advanceable within the lumen of the catheter and the implant.

[0030] In one application example, the anchor channel is configured to extend through the catheter such that a distal region of the anchor channel is disposed within the lumen, the distal region having a distal aperture, and the anchor channel facilitates positioning of the aforementioned portion of the wall at the aforementioned site.

[0031] In one application, the anchor driver, while coupled to the tissue anchor, is advanceable through the longitudinal cavity to the aforementioned site to advance the tissue anchor into the aforementioned site, and is removable from the longitudinal cavity (whether coupled to the tissue anchor or decoupled from the tissue anchor) via the proximal opening of the catheter.

[0032] In one application, the anchor driver, when coupled to the tissue anchor, is advanceable through the longitudinal cavity to the implant to advance the tissue anchor into the lumen of the implant in a manner such that the tissue anchor reaches the aforementioned portion of the wall, and is removable from the longitudinal cavity via the proximal opening of the catheter.

[0033] In one application example, the ultrasonic transmitter / receiver can be advanced through the longitudinal cavity into the lumen of the implant so that the ultrasonic transmitter / receiver faces the aforementioned portion of the wall, and can be removed from the longitudinal cavity through the proximal opening of the catheter.

[0034] In one application, the anchor driver is advanceable through the longitudinal cavity to the implant only if an ultrasound transmitter / receiver is not disposed through the longitudinal cavity.

[0035] In one application, the ultrasonic tool includes an anchor channel, and the ultrasonic transmitter / receiver is disposed in a distal region of the anchor channel, and the anchor channel is configured to position the ultrasonic transmitter / receiver at a location at the site, which can be within the lumen of the implant and facing the portion of the wall of the implant.

[0036] In one application, the ultrasonic transmitter / receiver is shaped as a ring that defines a passageway therethrough.

[0037] In one application, the anchor driver, when coupled to the tissue anchor, is advanceable through the longitudinal cavity to the implant to advance the tissue anchor through the passageway in a manner such that the tissue anchor reaches a forward portion of the implant (e.g., a forward portion of a wall of the implant).

[0038] For one application, the implant comprises an annuloplasty structure. For one application, the annuloplasty structure comprises a sleeve defined by a wall.

[0039] In one application, the annuloplasty structure further comprises a contraction member and an actuatable adjustment mechanism, the adjustment mechanism configured to apply tension to the contraction member when actuated, and the contraction member configured to adjust the length of the annuloplasty structure when tensioned by actuating the adjustment mechanism.

[0040] According to one application, a method for implanting an implant into tissue of a subject is provided. The method includes transluminally advancing the implant (or a portion thereof) into the tissue using a delivery tool comprising a catheter. The catheter has a distal portion with a distal opening. The method further includes positioning an ultrasonic transmitter / receiver of an ultrasonic tool adjacent to or near a portion of the implant located at / near the tissue site. The method further includes evaluating the tissue site by using the ultrasonic tool to transmit ultrasonic energy to the site and detect reflected ultrasonic energy reflected from the site.

[0041] The method can include using an external control assembly operably coupled to the distal portion of the catheter to steer the distal portion of the catheter so that the distal opening is disposed at the aforementioned site of tissue, and the control assembly can also be used to hold the portion of the implant exposed out of the distal opening against the aforementioned site of tissue (and the method can include holding the portion of the implant exposed from the distal opening against the aforementioned site of tissue).

[0042] For some applications, the method includes evaluating the site of tissue by using an ultrasound tool to transmit ultrasound energy through the portion of the implant to the site and detect reflected ultrasound energy reflected from the site.

[0043] The method also includes thereafter anchoring the implant to the tissue by using an anchor driver to drive a tissue anchor through the aforementioned portion of the implant and into the aforementioned site in the tissue. In some applications, the aforementioned portion of the implant can be a portion of a wall of the implant, a portion of a sleeve of the implant, a portion of a side of the implant, a length of the implant, an area of ​​the implant, a component of the implant, a tissue anchor (e.g., all or a portion of the tissue anchor), etc.

[0044] In some applications, the tissue includes tissue of a valve annulus of the subject's heart, the implant includes an annuloplasty structure, and anchoring the implant to the tissue includes anchoring a portion of the annulus structure to the tissue of the valve annulus.

[0045] For some applications, the portion of the implant is a portion of a wall of the implant, and detecting reflected ultrasonic energy reflected from the region of tissue includes detecting reflected ultrasonic energy reflected back through the portion of the wall. For some applications, the implant includes a lumen surrounded by the wall of the implant, and an ultrasonic tool or an ultrasonic transceiver of the ultrasonic tool is positioned within the lumen of the implant when transmitting ultrasonic energy into the region and / or detecting ultrasonic energy reflected from the region.

[0046] For some applications, the anchor driver is coaxial with the ultrasonic tool when anchoring the implant to tissue, hi some applications, the tissue anchor is coaxial with a distal region and / or distal end of the ultrasonic tool and / or ultrasonic transmitter / receiver when anchoring the implant to tissue.

[0047] For some applications, the method further includes simultaneously using the ultrasonic tool and the anchor driver while anchoring the implant to the tissue. For some applications, the method further includes continuing to assess the site of tissue using the ultrasonic tool while anchoring the implant to the tissue by driving the tissue anchor into the site of tissue.

[0048] In some applications, the ultrasonic transmitter / receiver of the ultrasonic tool is disposed in a distal region of the ultrasonic tool, and holding the anterior portion of the implant in abutment against the anterior portion of the tissue includes applying a pressing force against the anterior portion using the ultrasonic tool (which in some applications can optionally be done from within the lumen), and driving the tissue anchor includes driving the tissue anchor through a passage defined by the ultrasonic transmitter / receiver.

[0049] In one application, transluminally advancing the implant into the tissue using the catheter includes transfemorally advancing the implant into the tissue using the catheter. In one application, transluminally advancing the implant into the tissue using the catheter includes transseptally advancing the implant into the tissue using the catheter.

[0050] For some applications, the method includes positioning the anchor channel such that a distal region of the anchor channel is disposed at or near the aforementioned site, the anchor channel defining a longitudinal cavity, the distal region including a distal aperture, the distal aperture being disposed in the aforementioned portion of the implant. The method may further include distally advancing an anchor driver coupled to the tissue anchor through the longitudinal cavity to the aforementioned site, with the distal aperture disposed at or near the aforementioned site.

[0051] In some applications, anchoring the implant to the tissue includes anchoring the anterior portion of the implant to the anterior portion of the tissue while using an anchor channel to hold the anterior portion of the implant at the anterior portion of the tissue.

[0052] For some applications, positioning the ultrasonic transmitter / receiver includes advancing an ultrasonic tool distally through the longitudinal cavity with the distal aperture disposed at the aforementioned site.

[0053] For some applications, the method includes withdrawing the ultrasonic transmitter / receiver from the longitudinal cavity through the proximal opening of the catheter while using the anchor channel to hold the preceding portion of the implant at the preceding site of tissue before advancing the anchor driver distally through the longitudinal cavity to the implant.

[0054] For some applications, the ultrasonic tool includes a connector and an ultrasonic controller including circuitry and a user interface, and the method includes using the connector to relay data representing reflected ultrasonic energy detected by the ultrasonic transceiver from the ultrasonic controller to the ultrasonic controller, and using circuitry of the ultrasonic controller to analyze the reflected ultrasonic energy.

[0055] For some applications, analyzing the reflected ultrasound energy includes running a data analysis program on the circuit. hi one application, analyzing the reflected ultrasound energy includes evaluating an image displayed on a user interface.

[0056] For some applications, the tissue anchor is a first tissue anchor, the aforementioned portion of the implant is the first portion of the implant, the aforementioned site is the first site of the tissue, and driving the tissue anchor into the aforementioned site of the tissue includes driving the first tissue anchor into the first site of the tissue. This can be performed while (or by) the first tissue anchor is connected / coupled to the first portion of the implant. Furthermore, anchoring the implant to the tissue can further include, after driving the first tissue anchor into the first site of the tissue, driving a second tissue anchor into a second site of the tissue. This can be performed while (or by) the second tissue anchor is connected / coupled to the second portion of the implant.

[0057] For some applications, the first portion is located in the left fibrous trigone of the annulus, and anchoring the implant to the tissue includes driving a first tissue anchor into the first portion at the left fibrous trigone.

[0058] In some applications, the first portion is located in the right fibrous trigone of the annulus, and anchoring the implant to the tissue includes driving a first tissue anchor into the first portion at the right fibrous trigone.

[0059] For some applications, the implant comprises an annuloplasty structure, the annuloplasty structure comprising a contraction member (e.g., a contraction wire, a contraction suture, a contraction line, etc.). For one application, the method includes adjusting the size of the annulus of the native valve by tensioning the contraction member. For one application, the method includes adjusting the length of the annuloplasty structure by tensioning the contraction member.

[0060] For some applications, the implant includes an annuloplasty structure, the wall of the implant being shaped to define a sleeve of the annuloplasty structure, the annuloplasty structure including a contraction member extending along at least a portion of the sleeve. In one application, the method includes adjusting annulus size of the native valve by tensioning the contraction member. The method may include adjusting a length of the annuloplasty structure by tensioning the contraction member.

[0061] For some applications, adjusting the size of the annulus of the native valve by tensioning the contraction member includes tensioning the contraction member by actuating an adjustment mechanism.

[0062] For some applications, adjusting the length of the structure by tensioning the contraction member includes tensioning the contraction member by actuating an adjustment mechanism.

[0063] For some applications, the adjustment mechanism includes a rotatable spool coupled to the contraction member, and actuating the adjustment mechanism to apply tension to the contraction member includes rotating the spool.

[0064] In some applications, the method includes (i) steering a distal portion of the catheter such that a distal opening is disposed at or near the second region of tissue after driving a first tissue anchor into the first region of tissue and (ii) before driving a second tissue anchor into the second region of tissue, holding a second portion of the implant at or near the second region of tissue, and evaluating the second region of tissue by using an ultrasound tool to both transmit ultrasonic energy to the second region and detect reflected ultrasonic energy reflected from the second region.

[0065] In some applications, driving the second tissue anchor into the second region of the tissue includes driving the second tissue anchor into the second region of the tissue while the ultrasonic transmitter / receiver remains within the catheter and is located at or near the second portion of the implant.

[0066] In some applications, evaluating the second region of tissue includes evaluating the second region of tissue without removing the ultrasound transmitter / receiver from the catheter and / or from near the native heart valve between evaluating the first region of tissue and evaluating the second region of tissue.

[0067] For some applications, the method includes retracting the ultrasound transmitter / receiver from the lumen of the implant (i) after assessing the first region of tissue and (ii) before driving a first tissue anchor into the first region of tissue; and (i) after driving the first tissue anchor into the first region of tissue and (ii) before assessing a second region of tissue. withdrawing the anchor driver from the implant; Thereafter, advancing the ultrasonic transmitter / receiver into the lumen of the implant so that the ultrasonic transmitter / receiver faces the second portion.

[0068] The above methods can be performed on live animals or on simulations such as cadavers, cadaver hearts, and simulators (eg, stimulated body parts, hearts, tissues, etc.).

[0069] According to one application, there is also provided a method for implanting an implant into tissue of a subject. The implant includes a wall surrounding a lumen. The method includes transluminally advancing the implant into tissue using a delivery tool including a catheter, the catheter having a distal portion with a distal opening. The method includes using an external control assembly operably coupled to the distal portion of the catheter to steer the distal portion of the catheter so that the distal opening is disposed at or opposite a site of the tissue. In some applications, the control assembly can be used to hold a portion of the implant exposed from the distal opening in abutment against the site of the tissue (and the method can include holding a portion of the implant exposed from the distal opening in abutment against the site of the tissue).

[0070] The method further includes positioning an ultrasonic transceiver of an ultrasonic tool within the lumen of the implant and facing the portion of the wall. The method further includes evaluating the portion of tissue by using the ultrasonic tool to transmit ultrasonic energy through the portion of the wall and into the portion and detect reflected ultrasonic energy reflected from the portion.

[0071] The method may also include subsequently anchoring the implant to the tissue by using an anchor driver to drive a tissue anchor through the aforementioned portion of the wall and into the aforementioned site of tissue.

[0072] In one application example, wherein the tissue comprises annulus tissue of the subject's heart, the implant comprises an annulus-forming structure, the wall portion is a wall portion of the annulus structure, and anchoring the implant to the tissue comprises anchoring a portion of the wall portion of the annulus-forming structure to the annulus tissue.

[0073] In one application, detecting reflected ultrasound energy reflected from the region of tissue includes detecting reflected ultrasound energy reflected back through the portion of the wall.

[0074] In one application example, the ultrasonic transmitter / receiver of the ultrasonic tool is disposed in a distal region of the ultrasonic tool, and holding the aforementioned portion of the wall against the aforementioned site of tissue includes applying a pushing force against the aforementioned portion from within the lumen using the ultrasonic tool, and driving the tissue anchor includes driving the tissue anchor through a passage defined by the ultrasonic transmitter / receiver.

[0075] In one application, transluminally advancing the implant into the tissue using the catheter includes transfemorally advancing the implant into the tissue using the catheter.

[0076] In one application, transluminally advancing the implant to the tissue using the catheter includes transseptally advancing the implant to the tissue using the catheter.

[0077] In one application, the method includes positioning an anchor channel such that a distal region of the anchor channel is disposed within the lumen, the anchor channel defining a longitudinal cavity, the distal region including a distal aperture, the distal aperture being disposed in the preceding portion of the wall. The method may further include distally advancing an anchor driver coupled to the tissue anchor through the longitudinal cavity and to the implant, with the distal aperture being disposed in the preceding portion of the wall.

[0078] In one application, anchoring the implant to the tissue includes anchoring the anterior portion of the wall to the anterior portion of the tissue while using the anchor channel to hold the anterior portion of the wall in abutment against the anterior portion of the tissue.

[0079] In one application, positioning the ultrasonic transmitter / receiver includes advancing an ultrasonic tool distally through the longitudinal cavity with a distal aperture disposed in the aforementioned portion of the wall.

[0080] In one application, the method includes withdrawing the ultrasonic transmitter / receiver from the longitudinal cavity through the proximal opening of the catheter while using the anchor channel to hold the preceding portion of the wall against the preceding portion of the tissue before advancing the anchor driver distally through the longitudinal cavity to the implant.

[0081] In one application, the ultrasonic tool includes a connector and an ultrasonic controller having circuitry and a user interface, and the method includes using the connector to relay data representing reflected ultrasonic energy detected by the ultrasonic transceiver from the ultrasonic controller, and using circuitry of the ultrasonic controller to analyze the reflected ultrasonic energy.

[0082] In one application, analyzing the reflected ultrasound energy includes running a data analysis program on the circuit. hi one application, analyzing the reflected ultrasound energy includes evaluating an image displayed on a user interface.

[0083] In one application, the tissue anchor is a first tissue anchor, the preceding portion of the wall is a first portion of the wall, the preceding location is a first location of the tissue, and driving the tissue anchor through the preceding portion of the wall and into the preceding location of the tissue includes driving the first tissue anchor through the first portion of the wall and into the first location of the tissue. Further, anchoring the implant to the tissue may further include driving a second tissue anchor through a second portion of the wall and into the second location of the tissue after driving the first tissue anchor through the first portion of the wall and into the first location of the tissue.

[0084] In one application, the first portion is located in the left fibrous trigone of the annulus, and anchoring the implant to the tissue includes driving a first tissue anchor through a first portion of the wall and into the first portion at the left fibrous trigone.

[0085] In one application, the first portion is located in the right fibrous trigon of the annulus, and anchoring the implant to the tissue includes driving a first tissue anchor through a first portion of the wall and into the first portion at the right fibrous trigon.

[0086] In one application, the implant includes an annuloplasty structure, the wall portion shaped to define a sleeve of the annuloplasty structure, the annuloplasty structure including a contraction member extending along at least a portion of the sleeve, and the method including adjusting the length of the structure by applying tension to the contraction member.

[0087] In one application, adjusting the length of the structure by tensioning the contraction member includes tensioning the contraction member by actuating an adjustment mechanism.

[0088] In one application, the adjustment mechanism includes a rotatable spool coupled to the contraction member, and actuating the adjustment mechanism to apply tension to the contraction member includes rotating the spool.

[0089] In one application, the method includes (i) steering a distal portion of the catheter so that a distal opening is disposed on an opposite side of the second portion of the tissue after driving a first tissue anchor through the first portion of the wall and (ii) before driving a second tissue anchor through the second portion of the wall and into the second portion of the tissue, holding the second portion of the wall in abutting relation against the second portion of the tissue, and evaluating the second portion of the tissue by using an ultrasound tool to both transmit ultrasound energy through the second portion of the wall into the second portion and detect reflected ultrasound energy reflected from the second portion.

[0090] In one application example, driving a second tissue anchor through the second portion of the wall and into the second region of the tissue includes driving the second tissue anchor through the second portion of the wall and into the second region of the tissue while the ultrasonic transmitter / receiver remains within the lumen of the implant and faces the second portion of the wall.

[0091] In one application, evaluating the second region of tissue includes evaluating the second region of tissue without removing the ultrasound transmitter / receiver from within the lumen of the implant between evaluating the first region of tissue and evaluating the second region of tissue.

[0092] In one application, the method includes withdrawing an ultrasound transmitter / receiver from the lumen of the implant (i) after assessing a first region of the tissue and (ii) before driving a first tissue anchor through a first portion of the wall; and (i) after driving a first tissue anchor through the first portion of the wall into the first region of the tissue and (ii) before assessing a second region of the tissue. withdrawing the anchor driver from the implant; Thereafter, advancing the ultrasonic transmitter / receiver into the lumen of the implant so that the ultrasonic transmitter / receiver faces the second portion of the wall.

[0093] The above methods can be performed on live animals or on simulations such as cadavers, cadaver hearts, simulators (eg, stimulated body parts, hearts, tissues, etc.), and the like.

[0094] According to one application, there is further provided a method, comprising: placing an indicator wire within a cardiac vessel of the subject; generating a physical field relative to the indicator wire by passing a current through the indicator wire; delivering a tissue anchor toward a portion of cardiac tissue adjacent to the blood vessel using an anchor delivery system, the anchor delivery system including a sensing element in a portion of the anchor delivery system; determining the location of this portion of the anchor delivery system; measuring a change in the physical field by placing this portion of the anchor delivery system within range of the indicator wire; and This measurement allows for the calculation of the distance between this portion of the anchor delivery system and a portion of the indicator wire. and determining by:

[0095] In one application, placing the indicator wire within the blood vessel includes placing the indicator wire within a coronary artery of the heart.

[0096] In one application, placing the indicator wire in the blood vessel includes placing the indicator wire in a coronary vein of the heart.

[0097] In one application, generating a physical field includes generating an electrostatic field.

[0098] In one application, generating a physical field includes generating an electromagnetic field.

[0099] In one application, generating a physical field includes generating an electric field.

[0100] In one application, generating a physical field includes generating a magnetic field.

[0101] In one application, the sensing element includes an ultrasonic sensor.

[0102] In one application, delivering the tissue anchor includes implanting an annuloplasty structure in an annulus of a heart of the subject using the tissue anchor.

[0103] In one application, the annuloplasty structure comprises a contraction member (eg, a contraction wire, a contraction line, a contraction suture, etc.) and one or more tissue anchors.

[0104] In one application, the annuloplasty structure is shaped to define a lumen, and delivering the tissue anchor includes moving the aforementioned portion of the anchor delivery system through the lumen of the annuloplasty structure and deploying the tissue anchor from within the lumen of the annuloplasty structure into the aforementioned site of tissue.

[0105] In one application, the annuloplasty structure does not include a lumen or a sleeve.

[0106] In one application, calculating the distance between the portion of the anchor delivery system and the portion of the indicator wire includes comparing the distance against a predetermined threshold.

[0107] In one application, delivering the tissue anchor includes deploying the tissue anchor into the portion of tissue in response to the comparison of the distance to a predetermined threshold.

[0108] In one application, delivering the tissue anchor includes deploying the tissue anchor into the portion of tissue in response to determining that the distance is less than a predetermined threshold.

[0109] In one application, the tissue anchor defines a first tissue anchor, and the method includes: After deploying the tissue anchor in the aforementioned portion of tissue, moving the aforementioned portion of the anchor delivery system to a second portion of tissue by determining a position of the aforementioned portion of the anchor delivery system; deploying a second tissue anchor in a second portion of tissue in response to comparing the distance to a predetermined threshold; Includes:

[0110] In one application, deploying the second tissue anchor includes deploying the second tissue anchor in the second portion of the tissue in response to determining that the distance is less than a predetermined threshold.

[0111] The above methods can be performed on live animals or on simulations such as cadavers, cadaver hearts, and simulators (eg, stimulated body parts, hearts, tissues, etc.).

[0112] According to one application, there is further provided a method, comprising: placing an indicator wire within a cardiac vessel of the subject; delivering a tissue anchor toward a portion of cardiac tissue adjacent to the blood vessel using an anchor delivery system, the anchor delivery system including an ultrasound sensing element in a portion of the anchor delivery system; determining the location of this portion of the anchor delivery system; measuring a change in the ultrasound field generated by the ultrasound sensing element by positioning this portion of the anchor delivery system within range of the indicator wire; and This measurement allows for the calculation of the distance between this portion of the anchor delivery system and a portion of the indicator wire. and determining by:

[0113] In one application, placing the indicator wire within the blood vessel includes placing the indicator wire within a coronary artery of the heart.

[0114] In one application, placing the indicator wire in the blood vessel includes placing the indicator wire in a coronary vein of the heart.

[0115] In one application, the aforementioned portion of tissue comprises tissue of a valve annulus of the subject, the method including advancing an annuloplasty structure to the valve annulus, the annuloplasty structure being shaped to define a lumen therethrough, and delivering a tissue anchor to the aforementioned portion of tissue includes delivering a tissue anchor from within the lumen of the annuloplasty structure to a portion of the tissue of the valve annulus.

[0116] In one application, delivering the tissue anchor includes implanting an annuloplasty structure in an annulus of a heart of the subject using the tissue anchor.

[0117] In one application, the annuloplasty structure comprises a contraction member (such as a contraction wire, contraction line, or contraction suture) and one or more tissue anchors.

[0118] In one application, the annuloplasty structure is shaped to define a lumen, and delivering the tissue anchor includes moving the aforementioned portion of an anchor delivery system through the lumen of the annuloplasty structure and deploying the tissue anchor from within the lumen of the annuloplasty structure into the aforementioned portion of tissue.

[0119] In one application, the annuloplasty structure does not include a lumen or a sleeve.

[0120] In one application, calculating the distance between the portion of the anchor delivery system and the portion of the indicator wire includes comparing the distance against a predetermined threshold.

[0121] In one application, delivering the tissue anchor includes deploying the tissue anchor into the portion of tissue in response to comparing the distance to a predetermined threshold.

[0122] In one application, delivering the tissue anchor includes deploying the tissue anchor into the portion of tissue in response to determining that the distance is less than a predetermined threshold.

[0123] In one application, the tissue anchor defines a first tissue anchor, and the method includes: After deploying the tissue anchor in the aforementioned portion of tissue, moving the aforementioned portion of the anchor delivery system to a second portion of tissue by determining a position of the aforementioned portion of the anchor delivery system; deploying a second tissue anchor in a second portion of tissue in response to comparing the distance to a predetermined threshold; Includes:

[0124] In one application, deploying the second tissue anchor includes deploying the second tissue anchor in the second portion of the tissue in response to determining that the distance is less than a predetermined threshold.

[0125] The above methods can be performed on live animals or on simulations such as cadavers, cadaver hearts, and simulators (eg, stimulated body parts, hearts, tissues, etc.).

[0126] The present invention will be more fully understood from the following detailed description of its applications taken in conjunction with the drawings. [Brief explanation of the drawings]

[0127] [Figure 1] 1 is a schematic diagram illustrating a multi-component system including an example implant and an example delivery tool for delivering the implant to tissue of a subject, according to some example applications. [Figure 2A]1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 2B] 1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 2C] 1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 2D] 1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 2E] 1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 2F] 1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 2G] 1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 2H] 1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 2I] 1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 2J] 1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 2K] 1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 2L]1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 2M] 1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 3A] 1 is a schematic diagram illustrating the position of an example ultrasound tool relative to cardiac tissue, according to some applications. [Figure 3B] 1 is a schematic diagram illustrating the position of an example ultrasound tool relative to cardiac tissue, according to some applications. [Figure 3C] 1 is a schematic diagram illustrating the position of an example ultrasound tool relative to cardiac tissue, according to some applications. [Figure 3D] 1 is a schematic diagram illustrating the position of an example ultrasound tool relative to cardiac tissue, according to some applications. [Figure 3E] 1 is a schematic diagram illustrating the position of an example ultrasound tool relative to cardiac tissue, according to some applications. [Figure 3F] 1 is a schematic diagram illustrating the position of an example ultrasound tool relative to cardiac tissue, according to some applications. [Figure 4] 1 is a schematic diagram illustrating a multi-component system including an example implant and an example delivery tool for delivering the implant to tissue of a subject, according to some example applications. [Figure 5A] 1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 5B] 1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 5C] 1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 5D]1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 5E] 1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 5F] 1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 5G] 1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 5H] 1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 5I] 1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 5J] 1A-1C are schematic diagrams illustrating an example delivery tool being used to deploy an example implant in cardiac tissue, according to some applications. [Figure 6] 1 is a flow chart that generally illustrates at least some steps of an example method for implanting an implant in tissue, according to some applications. [Figure 7A] FIG. 1 is a schematic diagram of an example system for detecting the position of a portion of an anchor delivery system, according to some applications. [Figure 7B] FIG. 1 is a schematic diagram of an example system for detecting the position of a portion of an anchor delivery system, according to some applications. DETAILED DESCRIPTION OF THE INVENTION

[0128] Reference is made to FIG. 1, which is a schematic diagram of a multi-component system 10 comprising an implant 20 and a delivery tool 8 for delivering the implant into the tissue of a subject. Throughout this application, the implant of system 10 is described as comprising an annuloplasty structure. An example annuloplasty structure referenced herein comprises a sleeve and / or lumen. However, it should be noted that in some applications, mutatis mutandis, the systems, devices, methods, techniques, etc. described herein may be used to facilitate implantation of other annuloplasty structures and / or other types of implants.

[0129] Implant 20, which is one example of one possible implant, includes a wall 28 surrounding a lumen 44. For example, as shown, implant 20 includes sleeve 30, and wall 28 may define a tubular sidewall surrounding lumen 44. In some applications, as shown, lumen 44 is an elongated lumen (e.g., the interior of implant 20 is shaped as an elongated lumen). In some applications, wall 28 defines a distal end wall 34 of implant 20 (e.g., in addition to the tubular sidewall).

[0130] 1 illustrates a distal portion of the system 10 with the implant 20 partially disposed within the catheter 22 of the tool 8, with a distal portion 62 of the implant exposed through the distal opening 26 of the catheter. In some applications, the implant 20 is an elongated implant along which an implant axis d12 is defined. When the implant 20 includes a sleeve 30, the implant axis can be considered the sleeve axis. Often, as shown, the distal portion 62 is disposed along the axis d12. The catheter 22 is configured to be advanced transluminally / transvascularly (e.g., transfemorally and / or transseptally) into the tissue where the implant 20 is to be implanted and used to deliver the implant to the tissue via the distal opening 26.

[0131] An external control assembly 64 is operably coupled to the distal portion 25 of the catheter 22 for steering the distal portion, such as to facilitate advancement of the catheter 22 to tissue. For example, as shown, the external control assembly 64 can include one or more handles 82 and steering control elements 84 configured to facilitate steering of the catheter 22 (e.g., the distal portion 25 of the catheter 22) and / or manipulation of the implant 20 by an operator.

[0132] As used herein (including the specification and claims), the term "steerable" means actively steerable, for example, by using an external controller to achieve bending. (This is in contrast to a flexible but non-steerable element that may bend in response to a resisting force during advancement through the subject's body.) In this manner, distal portion 25 can be steered to position one or more portions 70 of implant 20 (e.g., wall or portion thereof, sleeve or portion thereof, contraction member or portion thereof, anchor or portion thereof, side or portion thereof, component or portion thereof, length, width, area, etc.) against one or more tissue sites 68. Each of these sites can be positioned (i) distally from a respective portion of the implant and (ii) on opposite sides of distal opening 26.

[0133] For some applications, as shown, implant 20 is anchored to tissue by anchoring anchors 52 to corresponding anchoring sites 68 (e.g., first site 68a, second site 68b, etc.) in the tissue. For some applications, implant portions 70 (e.g., first site 70a, second site 70b, etc.) are anchored to corresponding anchoring sites 68 (e.g., first site 68a, second site 68b, etc.) in the tissue, such as by anchoring corresponding anchors 52 at corresponding sites of the implant.

[0134] For some applications, first portion 70a can be disposed within distal portion 62 of sleeve 30. For some applications, first portion 70a is disposed on distal end wall 34 of sleeve 30, as shown in Figures 2A-2K.

[0135] For some applications, catheter 22 is configured to be advanceable transfemorally and transseptally into tissue, although this is not meant to exclude other means and / or approaches for advancing catheter 22 into tissue.

[0136] For some applications, the distal portion 25 of the catheter 22 is radiopaque and / or includes one or more distinct radiopaque markers to facilitate positioning of the distal portion 25 at, against, or near the desired tissue site, which may also be used to facilitate placement of the wall portion 70 against the tissue site 68.

[0137] For some applications, delivery tool 8 further includes anchor channel 18 defining a longitudinal cavity 50 disposed along channel axis d14. Channel 18 is advanceable (e.g., slidable, threadable, etc.) within catheter 22.

[0138] Channel 18 may be advanceable through both catheter 22 and lumen 44 of implant 20. In such applications, sleeve 30 is often concentric with channel 18 (e.g., such that axis d12 is collinear with axis d14).

[0139] In some applications, prior to implantation (e.g., in an operating room or an adjacent room), distal region 24 of channel 18 is loaded into sleeve 30 and implant 20 is loaded into catheter 22. In this manner, distal region 24, including distal aperture 19 of channel 18, can be advanced distally within catheter 22 from a proximal opening of catheter 22 to a distal portion 25 of the catheter such that distal region 24 is disposed within lumen 44 of implant 20.

[0140] As shown, the channel 18 extends through the catheter 22 such that the distal region 24 including the distal aperture 19 of the anchor channel 18 is disposed within the lumen 44 of the implant 20, and the longitudinal cavity 50 terminates at the distal aperture.

[0141] For some applications, anchor channel 18 is configured to facilitate direct deployment of implant 20, for example, as described in U.S. Patent Application Publication No. 2018 / 0049875 to Iflah et al., mutatis mutandis. This application publication is incorporated herein by reference. For some applications, sleeve 30 comprises a flexible material such that sleeve 30 (e.g., sleeve portions 70) can be moved into position by moving anchor channel 18, such as by manipulating catheter 22. For example, sleeve 30 can comprise a braided fabric mesh including polyethylene terephthalate (e.g., Dacron®). As described in more detail below, portions 70 can be defined by the position of anchor channel 18 relative to implant 20. For example, in an initial position of anchor channel 18 within lumen 44, first portion 70a can be defined opposite distal aperture 19 (e.g., by being the portion of the implant that receives the first anchor to be advanced through cavity 50). Also, at a second position of the anchor channel within the lumen, a second portion 70b may be defined on the opposite side of the distal aperture (e.g., by being the portion of the implant that receives a second anchor to be advanced through the lumen).

[0142] For some applications, implant 20 includes a flexible elongate contraction member 42 (e.g., a contraction wire, contraction line, contraction suture, etc.). For some applications, as shown, implant 20 includes an annuloplasty structure that includes a flexible elongate contraction member 42. Contraction member 42 can be configured to extend along at least a portion of sleeve 30, such that the portion of the sleeve along which member 42 extends can be defined as the contraction portion of the sleeve. However, for some applications, the contraction member can be used without a sleeve, e.g., the contraction member can be connected and / or coupled directly to the anchor (e.g., through an eyelet or other portion of the anchor, or otherwise connected / coupled to the anchor), and contraction of the contraction member can condition the tissue anchor and thus the annulus into a different (e.g., smaller) shape / configuration without the need for a sleeve or even fabric. Contraction members described elsewhere herein can comprise wires, ribbons, ropes, or bands and can comprise flexible and / or superelastic materials such as nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the contraction member or contraction wire comprises a radiopaque material. For some applications, the contraction member is coated with polytetrafluoroethylene (PTFE). For some applications, the contraction member comprises multiple wires wrapped around each other to form a rope structure.

[0143] For some applications (including, for example, when the implant 20 comprises an annuloplasty structure), as shown, the structure further comprises an actuatable adjustment mechanism 40 that facilitates contraction and expansion of the structure. The adjustment mechanism 40 is coupled to the contraction member at an end portion of the contraction member. When actuated, the adjustment mechanism 40 applies tension to the contraction member, thereby adjusting the length of the implant and / or annuloplasty structure. For some applications, the adjustment mechanism 40 may be coupled to the sleeve 30 with a coupling 66 (e.g., sutures, adhesives, fasteners, etc.). For some applications, the adjustment mechanism 40 is coupled to an outer side surface of the sleeve 30.

[0144] In some applications in which implant 20 includes adjustment mechanism 40, system 10 includes a flexible longitudinal guide member 46 (e.g., a wire, line, guide, etc.) coupled to a portion of the adjustment mechanism. Guide member 46 extends proximally from adjustment mechanism 40 through catheter 22 (e.g., through a parallel side lumen of the catheter) and has a proximal end accessible from outside the subject's body.

[0145] In some applications in which the implant 20 includes a contraction member 42, the implant does not include a separate adjustment mechanism; instead, the contraction member is tensioned by pulling proximally, e.g., using an adjustment tool, while applying a reference force to the implant. In such applications, a locking member or lock (e.g., a clip, fastener, staple, crimper, clamp, etc.) can be locked relative to the contraction member 42 to lock into the applied tension. In some such applications, the locking member is a component of the implant and is therefore introduced into the subject simultaneously with the rest of the implant. Optionally, the locking member can be introduced after introduction of the implant into the subject, e.g., with an adjustment tool, etc. Implants without a separate adjustment mechanism as described herein can include a sleeve and / or lumen, or can be sleeveless or lumenless (e.g., can include a contraction member and tissue anchor without a sleeve or fabric, etc.).

[0146] 2A-2M, which are schematic illustrations showing tool 8 being used to deploy implant 20 in cardiac tissue 92 of a subject's heart 90, according to some applications.

[0147] Hereinafter, system 10 will be described as being used, inter alia, to advance implant 20 into and anchor the implant to cardiac tissue 92. In some applications, tissue 92 includes tissue of a valve annulus 88 of heart 90. In some applications, implant 20 comprises an annulus plasty structure, and in some such applications, anchoring the implant to tissue 92 includes anchoring wall 28 of the annulus structure to tissue of the valve annulus 88. However, this is not meant to preclude use of system 10 to deploy alternative implants to the valve annulus 88 and / or other tissue, mutatis mutandis.

[0148] Implant 20 is delivered generally transluminally to cardiac tissue 92 via catheter 22. While a transfemoral transseptal approach to the mitral valve is illustrated in Figure 2A, the scope of the present invention includes alternative approaches to the mitral valve, other locations within the heart (e.g., at the heart valves), and other locations in the body.

[0149] In some applications, implant 20 is delivered by advancing catheter 22 with the implant pre-disposed within catheter 22. Optionally, catheter 22 can be advanced first, followed by implant 20 being advanced through the catheter. In some such applications, implant 20 can be advanced with distal region 24 of anchor channel 18 pre-disposed within implant 20. In some such applications, anchor channel 18 can be introduced within implant 20 after advancement of implant 20.

[0150] The distal portion 25 of the catheter 22 can be steered, using the extracorporeal control assembly 64, to a position opposite a first site 68a in the cardiac tissue 92, the first site being disposed (i) distally from the first portion 70a of the implant (e.g., distally from the wall of the sleeve 30 and distally from the end wall 34, etc.) and (ii) opposite the distal opening 26 of the catheter (FIGS. 2A-2B). Similarly, in some such applications, the first site 68a can be defined by being disposed opposite the first site 70a.

[0151] In some applications, the sites 68 may be predefined prior to advancing the implant 20 and / or anchors 52 into tissue. For example, the sites 68 may be defined in relation to anatomical landmarks (e.g., the fibrous trigone or commissures) of the heart 90. Optionally, each site 68 may be defined ad hoc during implantation simply as a site where the implant and / or tissue anchor will be anchored.

[0152] In some applications, portions 70 may be predefined prior to advancing implant 20 into tissue. For example, portions 70 may be defined relative to a dimension (e.g., length) of implant 20 and / or may be separate portions or components of the implant. Optionally, implant 20 itself may not define portions 70 as separate portions; instead, each portion 70 may be defined ad hoc during implantation as a portion and / or component of the implant that will simply be anchored to tissue (e.g., the portion of the implant located on opposite sides of distal aperture 19 of anchor channel 18).

[0153] For some applications, as shown, the first portion of implant 20 that will be anchored to tissue (e.g., to first portion 68a) is distal end wall 34 of sleeve 30. That is, for some applications, first portion 70a is located at the distal end or distal end wall 34 of the implant.

[0154] 2A-2B, movement of the anchoring channel (e.g., by steering catheter 22) advances first portion 70a toward first anchoring site 68a. For some applications, distal portion 62 (e.g., distal end wall 34), including at least first portion 70a of wall 28, is advanced out of opening 26 of catheter 22.

[0155] In some applications in which implant 20 includes adjustment mechanism 40, the adjustment mechanism is disposed distally relative to the implant (i.e., in front of the implant) during implant advancement, as shown in FIG. 2A. For example, adjustment mechanism 40 can be disposed on the implant axis, or axis d12 (e.g., collinear with sleeve 30). In some such applications, mechanism 40 is coupled to sleeve 30 such that mechanism 40 can move (e.g., translate) from being collinear with axis d12 to being aligned with sleeve 30 ( FIG. 2B ).

[0156] For some applications, one or more couplings 66 (e.g., sutures, etc.) facilitate translational movement of adjustment mechanism 40 by flexibly and / or articulably coupling the mechanism to sleeve 30. For some applications, guide member 46 is tensioned or relaxed to reposition mechanism 40.

[0157] In some applications, it may be advantageous to (1) advance implant 20 into tissue while mechanism 40 is disposed on axis d12 (e.g., aligned with the sleeve) to maintain a small cross-sectional diameter of the implant for transluminal delivery, and (2) subsequently move mechanism 40 away from the implant axis (FIG. 2C), e.g., to allow end wall portion 34 of the sleeve to be positioned against the atrial surface of annulus 88.

[0158] For some applications, anchor channel 18 applies a pushing force against the distal end or other portion of the implant. For some applications, anchor channel 18 applies a pushing force against distal end wall 34 from within sleeve 30. For some such applications, the pushing force applied by channel 18 against end wall 34 facilitates advancing first portion 70a out of distal opening 26 of catheter 22. In this manner, first portion 70a of the wall (e.g., distal end wall 34) is positioned against first portion 68a of cardiac tissue 92 such that distal region 24 of anchor channel 18 is disposed within lumen 44 and distal aperture 19 of anchor channel 18 is disposed in first portion 70a (FIG. 2C).

[0159] As shown, a first portion 70a of the implant (e.g., distal end wall 34) may be positioned against a first region 68a disposed (i) distally from the first portion 70a and (ii) on the opposite side of the catheter's distal opening 26 ( FIG. 2C ). In some such applications, the pressing force applied by the channel 18 against the first portion 70a facilitates holding the portion 70a against the first region 68a of tissue, e.g., sandwiching the portion 70a between the tissue 92 and the aperture 19, e.g., whereby the region 68a is defined as the region at which the channel 18 holds the portion 70a against the first region 68a.

[0160] 2C, the delivery tool 8 further includes an ultrasonic tool 36 that transmits ultrasonic energy to the first region 68a to facilitate imaging of the region. For some applications, the ultrasonic tool 36 facilitates imaging of the region by transmitting ultrasonic energy through the first portion 70a of the implant (e.g., through the wall) and into the first region 68a. Typically, as shown, the ultrasonic tool 36 has an ultrasonic transceiver 38 at its distal end 37.

[0161] In some applications where the implant includes a wall through which anchors penetrate to secure the wall to tissue (e.g., side walls, walls surrounding or defining a lumen, etc.), positioning the ultrasonic tool and / or ultrasonic transmitter / receiver so that the wall is held between the ultrasonic tool and / or ultrasonic transmitter / receiver and the tissue or tissue site (e.g., when the ultrasonic tool is located within the lumen of the implant), holding the implant wall against the tissue site, and imaging the site can advantageously help optimize the positioning and anchoring of the implant to the tissue (e.g., to the annulus of a native heart valve) while avoiding obstacles, blood vessels, etc. This can help ensure that the wall is held in an ideal or optimized position when the anchor is driven through the wall and into the tissue to secure the implant to the tissue, as well as for subsequent site and anchoring operations. When the ultrasonic tool is positioned within the lumen of the implant, additional benefits can be obtained by having the ultrasonic tool enclosed within the lumen during imaging (e.g., reduced traumatic interference with the tissue and protection of the transmitter / receiver, etc.).

[0162] The ultrasonic tool 36 may be advanced distally within the longitudinal cavity 50 of the anchor channel 18 to a desired location (e.g., at or near a tissue site). For example, in some applications, the ultrasonic tool 36 may be advanced distally within the longitudinal cavity 50 of the anchor channel 18 to a position within the lumen 44 of the implant 20 and facing the first portion 70a of the wall ( FIG. 2C ). In some applications, the ultrasonic tool 36 is advanced distally through the longitudinal cavity 50 with the distal aperture 19 disposed at the tissue site and / or the first portion 70a, e.g., positioned to enable the ultrasonic transceiver 38 to transmit ultrasonic energy through the aperture 19 of the channel 18. In some applications, the ultrasonic tool 36 is advanced distally so that the distal end of the ultrasonic tool is approximately flush with the distal aperture 19. For some applications, the ultrasonic tool 36 is advanced distally such that at least a portion of the ultrasonic transceiver 38 protrudes distally through the distal aperture 19, as shown in FIG. 2C.

[0163] The ultrasonic tool 36 is used to image the first region 68a by transmitting ultrasonic energy 35 into the first region 68a. In some applications, the ultrasonic tool 36 is used to image the first region 68a by transmitting ultrasonic energy 35 through the first portion 70a into the first region 68a. That is, the ultrasonic energy reaches the first region 68a by passing through the first portion 70a of the wall 28.

[0164] With the ultrasonic transceiver 38 positioned within the cavity 50 of the anchor channel 18, a portion of the transmitted ultrasonic energy is reflected from portion 68a back to the transceiver, which detects the reflected ultrasonic energy. In some applications, with the ultrasonic transceiver 38 positioned within the cavity 50 of the anchor channel 18 facing the first portion 70a, a portion of the transmitted ultrasonic energy is reflected from portion 68a (via portion 70a of the wall 28) back to the transceiver, which detects the reflected ultrasonic energy.

[0165] Thus, the ultrasonic tool 36 can be considered "progressive" because (i) the first portion 68a is disposed distally from the implant and on the opposite side of the distal opening 26 of the catheter 22, (ii) the ultrasonic transmitter / receiver 38 is located in a position facing the first portion 68a (which could, for example, be within the lumen 44 of the implant and facing the first portion 70a of the wall), and (iii) the ultrasonic tool can be used to image the first portion 68a while ultrasonic energy is both transmitted by the ultrasonic transmitter / receiver and reflected back to the ultrasonic transmitter / receiver (e.g., via the first portion 70a).

[0166] For some applications, the anchor channel 18 (e.g., its distal aperture 19) is used to hold the first portion 70a against the first portion 68a. For some such applications, the ultrasonic tool 36 is advanced distally through the longitudinal cavity 50 with the aperture 19 holding the first portion 70a against the first portion 68a.

[0167] As will be further described herein below, it is hypothesized that holding the first portion 70a in abutting relation against the first region 68a by the anchor channel 18 and / or extending the distal end 37 of the ultrasonic tool 36 through the distal aperture 19 of the anchor channel 18 will facilitate use of the ultrasonic tool 36 to image the region.

[0168] Typically, the reflected ultrasonic energy is converted using an ultrasonic tool 36 into data (hereinafter "data") representative of the reflected ultrasonic energy detected by an ultrasonic transceiver 38. For some applications, as shown in FIG. 2C , the ultrasonic tool 36 further includes an ultrasonic controller 74 that is electronically coupled to the transceiver 38 (e.g., via one or more connectors 72) and configured to facilitate analysis of the reflected ultrasonic energy detected by the ultrasonic transceiver 38.

[0169] The ultrasound controller 74 may include circuitry 75 that is used to evaluate and / or analyze the ultrasound data. For example, the ultrasound controller 74 may be used to run a data analysis program in the circuitry 75. Alternatively or additionally, an image reflecting the data may be displayed on the user interface 60 (e.g., a monitor, screen, etc.) for evaluation by an operator.

[0170] Analysis of the ultrasound data may produce various analysis output parameters. For some applications, the analysis parameters may be displayed on the ultrasound controller 74 (e.g., on the user interface 60 of the ultrasound controller 74). In particular, for example, analysis of the data may determine the depth of tissue to which ultrasound energy is transmitted. For some such applications, a tissue depth of at least 7 mm (e.g., between 7 mm and 20 mm) may, alone or in combination with other parameters, indicate that the site 68 is suitable for anchoring a tissue anchor 52. Alternatively or additionally, analysis of the data may determine the radiodensity of the tissue to which ultrasound energy is transmitted. For some such applications, a radiodensity of at least 60 Hounsfield Units (HU) and / or less than 600 HU (e.g., between 60 HU and 600 HU) may, alone or in combination with other parameters, indicate that the site 68 is suitable for anchoring a tissue anchor 52. For some applications, setting an upper radiodensity limit (e.g., 600 HU) may be used to facilitate identification and avoidance of calcified tissue.

[0171] Analysis of the ultrasound data may provide additional information that may be displayed to the operator as a warning message on the ultrasound controller 74 (e.g., on the user interface 60 of the ultrasound controller 74). For example, analysis of the ultrasound data may indicate that (i) the ultrasound transceiver 38 is not positioned sufficiently close to (e.g., not pressing against) the tissue 92, (ii) a blood vessel 58 is present at the tissue site, and / or (iii) another portion of the implant (e.g., the constriction member 42) is disposed between the implant portion 70 and the site. The ultrasound controller 74 may be configured to display the additional warning message as it relates to the particular implant 20 and tissue 92 used with the system 10.

[0172] 3A-3F, which are schematic diagrams illustrating various positions of an ultrasonic tool 36 relative to cardiac tissue 92, according to some applications of the present invention. As shown, an ultrasonic transceiver 38 is disposed within the distal region 24 of the anchor channel 18 such that a distal end 37 of the ultrasonic tool 36 extends to the distal aperture 19 of the anchor channel. In the illustrated example, the tool 36 is disposed such that the distal end 37 (e.g., a portion of the ultrasonic transceiver 38) protrudes through the distal aperture 19 (e.g., to the first portion 70a). In this manner, ultrasonic energy 35 is transmitted from the transceiver 38 (which may penetrate the first portion 70a of the implant), and a portion of the ultrasonic energy is reflected back to the transceiver (which may also pass through the portion 70a of the implant). The reflected energy detected by the transceiver 38 is used (e.g., by an operator, facilitated, for example, by the controller 74) to determine the suitability of a particular site 68 to receive a tissue anchor 52 for anchoring the implant to tissue at the tissue site.

[0173] In some applications, as shown in Figure 3A, the anchor channel 18 (e.g., its distal aperture 19) is used to clamp the sleeve 30 against cardiac tissue 92, holding the first portion 70a against a location 68 of the tissue 92. Ultrasonic energy 35 penetrates the tissue, and a portion of the energy is reflected back to the transceiver 38. The check marks in Figure 3A indicate that ultrasound data suggests that the particular location 68 in Figure 3A is suitable for anchoring the sleeve 30 to the tissue.

[0174] 3B-3F illustrate various tissue sites 68 that may be unsuitable for anchoring sleeve 30 to tissue, with this unsuitability being determined using ultrasound tool 36. In each of these figures, this unsuitability is indicated with an "X."

[0175] 3B-3E show portion 70 of sleeve 30 positioned against a region 68 that has suboptimal tissue thickness 92 (e.g., located at the leaflets of a heart valve, FIG. 3B) or suboptimal density 92 (FIG. 3E). Anchoring implant 20 to such tissue regions is often undesirable because, for example, these regions may not have sufficient strength to retain tissue anchor 52.

[0176] FIG. 3C shows that first portion 70a of the wall is not positioned in sufficient direct contact with site 68. Generally, it is preferred that portion 70a be in contact with site 68 to facilitate positioning the ultrasonic transmitter / receiver as close as possible to site 68, e.g., sandwiching the wall of the implant between the transmitter / receiver and site 68. Such suboptimal positioning can be detected using an ultrasound tool, and in such a situation, the device and / or implant can be repositioned. In some applications (e.g., some applications using system 310 described hereinafter), identifying that such optimal positioning of the ultrasonic transmitter / receiver has been achieved can facilitate ensuring that the wall of the implant is held against the tissue site during anchoring. It is hypothesized that ensuring that the wall of the implant is held against the tissue site during anchoring facilitates optimal anchoring of tissue anchor 52 to tissue 92.

[0177] 3D shows portion 70 of sleeve 30 positioned against site 68 where blood vessel 58 is located. Anchoring implant 20 at such a tissue site may be undesirable. For example, driving tissue anchor 52 into such a site may result in damage to the blood vessel, thereby increasing the risk of surgical complications. In some applications, ultrasound controller 74 is configured to indicate the presence of blood vessel 58 to the operator.

[0178] 3F shows that portion 70 of sleeve 30 sandwiches another portion of implant 20 (e.g., contraction member 42, as shown) between portion 70 and site 68. Anchoring implant 20 in such a situation may be undesirable. For example, the presence of another portion of implant 20 may interfere with the anchoring and / or function of the implant. For example, in some applications, anchoring implant 20 in such a situation could theoretically interfere with the function of the contraction member.

[0179] 3B-3F, if analysis of the data (by circuitry 75 of ultrasonic tool 36 or by an operator) suggests that site 68 is unsuitable for anchoring an implant to that tissue, control assembly 64 can be used to steer distal portion 25 of catheter 22 to an alternate site 68 in tissue 92. While the anchor channel is used to position the implant at alternate site 68, ultrasonic tool 36 is used to image alternate site 68 as described above with reference to FIG. 2C. In some applications, ultrasonic tool 36 can be used to image multiple alternate sites 68 until analysis of the data suggests that the alternate site 68 is suitable for anchoring an implant and / or tissue anchor to tissue 92.

[0180] As explained above with reference to FIG. 3A , if the data indicates that portion 68 is suitable for anchoring the implant to tissue, then the ultrasonic transmitter / receiver 38 is withdrawn from the longitudinal cavity 50 through the proximal opening of the catheter (and in some applications, the ultrasonic transmitter / receiver is withdrawn from the lumen 44 of the implant 20). In some applications, this is done while holding (e.g., pressing) a first portion 70a of the wall 28 against portion 68 at the anchor channel 18 (e.g., its distal aperture 19), as shown, for example, in FIG. 2D , mutatis mutandis.

[0181] As shown in FIG. 2E, tool 8 further includes an anchor driver 16 configured to anchor the implant to tissue by driving tissue anchor 52 (e.g., its tissue-penetrating portion) into first portion 68a. If the implant includes a sleeve or other lumen, anchor 52 may be driven through first portion 70a of implant 20 (e.g., its sleeve 30) and then into first portion 68a. Anchor driver 16 may include an elongated, flexible shaft (which can be tubular or of other design). For some applications, driver 16 may be as described, mutatis mutandis, in U.S. Patent Application Publication No. 2018 / 0049875 to Iflah et al., which is incorporated herein by reference.

[0182] For some applications, system 10 and / or implant 20 include a plurality of tissue anchors 52, often between about 5 and about 20 anchors, e.g., about 10 or about 16 anchors. Often, but not necessarily, anchors 52 comprise a biocompatible material such as stainless steel 316LVM. For some applications, anchors 52 comprise nitinol. For some applications, anchors 52 are completely or partially coated with a non-conductive material.

[0183] 2E-2F, the driver 16 can be advanced through the longitudinal cavity 50 into the implant 20 only while the ultrasonic transmitter / receiver is not disposed therethrough. That is, in such applications, either the ultrasonic transmitter / receiver 38 or the anchor driver 16 can be disposed through the cavity 50 of the anchor channel 18 at a given time.

[0184] The driver 16 may be advanced through the longitudinal cavity 50 of the channel 18 into the implant while coupled to the tissue anchor 52. In some applications, the driver 16 advances the anchor 52 into the lumen 44 of the implant while the anchor 52 is coupled to the driver 16 in a manner such that the anchor reaches the first portion 70a of the implant or wall opposite the aperture 19, as described above.

[0185] As described above, first portion 70a can be defined by the location of channel 18 within lumen 44; for example, first portion 70a can be defined as being located on the opposite side of aperture 19. First portion 68a can be the portion of tissue to which implant 20 (e.g., first portion 70a thereof) is intended to be anchored and can be disposed distally from first portion 70a. First portion 68a can be located on the opposite side of distal opening 26 of catheter 22. Thus, first portion 70a can be the portion of the implant (e.g., portion of wall 28 of the implant) disposed between aperture 19 and first portion 68a.

[0186] For some applications, the driver 16 advances the anchor 52 through the anchor channel 18 to the first portion 70a while the first portion 70a is pre-disposed in the first region 68a. In some applications, as shown, the anchor channel 18 (e.g., its distal aperture 19) is used to hold the first portion 70a against the first region 68a, sandwiching the first portion 70a between the aperture and the first region 68a when (i) the anchor driver 16 is advanced through the cavity 50 and into the implant 20 ( FIG. 2E ) and (ii) the first portion 70a of the wall 28 is anchored against the first region 68a.

[0187] It is hypothesized that holding the first portion 70a of the wall 28 against the first portion 68a in the anchor channel 18 throughout (i) imaging of the site 68, (ii) withdrawal of the ultrasonic transceiver 38 from the longitudinal cavity 50, (iii) advancement of the anchor driver 16 distally through the longitudinal cavity 50 to the implant 20, and (iv) anchoring of the first portion 70a of the wall 28 against the first site 68a in the tissue contributes to the precision with which the implant is anchored to the tissue. That is, using the anchor channel 18 to stably hold the first portion 70a of the wall 28 against the first site 68a facilitates anchoring of the implant 20 at the particular suitable site 68 identified using the ultrasonic tool 36.

[0188] Thus far, tissue anchor 52 has been described as first tissue anchor 52a, portion 70 has been described as first portion 70a, and region 68 has been described as first region 68a. Thus, anchoring implant 20 can include driving first anchor 52a through first portion 70a of wall 28 and into first region 68a of tissue 92.

[0189] 2G-2K, anchoring implant 20 may include anchoring one or more additional portions 70 of wall 28 to additional portions of tissue 92 (e.g., of valve annulus 88) by driving additional tissue anchors 52 through the additional portions 70 and into the additional portions of tissue 92. Similar to what was described herein above with reference to first portion 70a and first portion 68a, each additional portion 70 may be held in abutment against a respective portion 68, which is imaged using ultrasound tool 36, and anchor 52 used to anchor the portion to the portion 68. Often, as described herein above with reference to FIGS. 3A-3F, data representing reflected ultrasound energy is analyzed to determine the suitability of each portion prior to anchoring anchor 52.

[0190] 2G shows anchor driver 16 being withdrawn and second portion 70b of sleeve 30 (i.e., the portion of the sleeve proximal to end wall 34) being released from channel 18 by retracting channel 18 proximally relative to the sleeve. Depending on the tension applied between the first and second tissue anchor sites, the section of sleeve 30 disposed between first portion 70a and second portion 70b may remain in a tubular shape or may flatten.

[0191] 2H, second portion 70b can be positioned at second anchoring site 68b, such as by repositioning distal portion 25 of catheter 22, and ultrasonic tool 36 is re-advanced distally relative to distal region 24 of anchor channel 18. Re-advancement of ultrasonic tool 36 can occur before or after positioning portion 70b at site 68b. As described above, anchor channel 18, anchor driver 16, and ultrasonic tool 36 can be sized such that only one of the anchor driver or ultrasonic tool can be disposed within longitudinal cavity 50 of anchor channel 18 at a given time. With anchor driver 16 withdrawn from cavity 50, ultrasonic transmitter / receiver 38 can be advanced distally through the cavity to the second anchoring site and / or implant 20 (e.g., facing second portion 70b).

[0192] FIG. 2H illustrates that the distal portion 25 of the catheter 22 may be repositioned multiple times relative to multiple possible tissue sites until a suitable site 68b is identified.

[0193] For some applications, the maximum distance between first portion 68a and second portion 68b is determined by the length of sleeve 30 previously released from channel 18. That is, for some applications, distal portion 25 of catheter 22 can be repositioned to second portion 68b anywhere within an arc having a diameter equal to this maximum distance, centered about first tissue anchor 52a.

[0194] As described herein above with reference to Figure 2D, Figure 2I shows the ultrasonic tool 36 being withdrawn from the anchor channel 18. As described for the first anchor 52a, mutatis mutandis, the anchor channel 18 (e.g., its distal aperture 19) may be used to hold the second portion 70b against the second section 68b while the ultrasonic tool 36 is withdrawn and the anchor driver 16 is re-advanced with the second anchor 52b.

[0195] Further, similar to the anchoring of first anchor 52a, Figure 2J shows anchor driver 16 being advanced distally within cavity 50 of anchor channel 18 to second portion 70b. As described above with respect to anchoring first anchor 52a, Figures 2J-2K show an example of second tissue anchor 52b being deployed through second portion 70b of wall 28. Second tissue anchor 52b may be deployed by driving the second anchor through wall 28 of sleeve 30 and into cardiac tissue 92 at second location 68b.

[0196] As shown, second anchor 52b can be deployed proximally (relative to implant 20) from first anchor 52a.

[0197] 2M shows the entire length of the implant 20 (e.g., sleeve 30) anchored to the valve annulus 88 by multiple anchors 52. In some applications, the implant 20 (e.g., sleeve 30) is anchored around the valve annulus between the right and left fibrous trigones as shown. After anchoring is complete, the channel 18 is withdrawn. In some applications, the catheter 22 is also withdrawn.

[0198] After the implant 20 is anchored to the annulus 88, the implant 20 (e.g., the sleeve 30 or a contraction portion thereof) may be contracted, such as by tensioning the contraction member 42. As explained above, the adjustment mechanism 40 is configured to adjust the length of the implant 20 (e.g., the sleeve 30 of the annuloplasty structure) by tensioning the contraction member 42, for example, as described in U.S. Patent Application Publication No. 2018 / 0049875 to Iflah et al., mutatis mutandis.

[0199] In such applications, guide member 46 may remain coupled to implant 20 (e.g., to adjustment mechanism 40) after removal of channel 18 (and optionally, catheter 22). As shown in FIG. 2M, adjustment tool 47 may be advanced along (e.g., over and along) guide member 46 to adjustment mechanism 40 and used to actuate the adjustment mechanism. Adjustment tool 47 may comprise a rotation tool and, as described above, may be configured to tension contraction member 42 and thus contract implant 20 (e.g., sleeve 30, etc.) by actuating (e.g., rotating) adjustment mechanism 40. In some applications, adjustment mechanism 40 comprises a rotating spool to which contraction member 42 is coupled, and counter-rotation of the spool adjusts the degree of tension in contraction member 42. Anchoring portion 70 to anchoring site 68 adjusts (e.g., shortens) the length of the structure, thereby adjusting (e.g., shortening) the circumference of annulus 88.

[0200] In some applications, implant 20 does not include a separate adjustment mechanism, and instead the contraction member is tensioned, e.g., by pulling proximally with, e.g., an adjustment tool, while applying a reference force to the implant. In such applications, a locking member or lock (e.g., a clip, fastener, staple, crimper, clamp, etc.) can be locked to contraction member 42 to lock under the applied tension. In some such applications, the locking member or lock is a component of the implant and is therefore introduced into the subject simultaneously with the rest of the implant. Optionally, the locking member or lock can be introduced after introduction of the implant into the subject, e.g., with an adjustment tool. Implants without a separate adjustment mechanism as described herein can include a sleeve and / or lumen, or can be sleeveless or lumenless (e.g., can include a contraction member and tissue anchor without a sleeve or fabric, etc.).

[0201] Once the desired level of structural adjustment is detected, for example, by monitoring the degree of valve regurgitation using echocardiography (e.g., Doppler echocardiography) and / or fluoroscopy, the adjustment tool 47 and guide member 46 are withdrawn from the heart. Typically, the implant 20 is detached from the delivery tool 8, and the delivery tool is transluminally withdrawn from the subject's heart 90.

[0202] Reference is now made to Figure 4, which is a schematic illustration of a multi-component system 310 including an implant 20 and a delivery tool 308 for delivering the implant to tissue of a subject, according to some applications.

[0203] Except where indicated, system 310 may be equivalent to or similar to system 10 described above and may be used in a manner similar to system 10, mutatis mutandis. For example, components having the same names in these systems generally share similar features and perform similar functions to one another. Components having the same reference numerals are generally interchangeable between delivery tool 8 and delivery tool 308. Therefore, the following description of system 310 will focus on features unique to system 310.

[0204] Delivery tool 308 includes an ultrasonic tool 336 that includes an ultrasonic transmitter / receiver 338 and an anchor channel 318. That is, the ultrasonic tool of system 10 is separate from and movable relative to the anchor channel of system 10, while the ultrasonic tool of system 310 is a component of the anchor channel of system 310. In such applications, ultrasonic transmitter / receiver 338 may be fixedly positioned at a distal end 337 of ultrasonic tool 336 (e.g., at the distal end of channel 318). In such applications, often ultrasonic tool 336 is advanceable through catheter 22 and implant 20 in a manner similar to that described herein above with reference to anchor channel 318 of delivery tool 8. Furthermore, similar to anchor channel 18 described above, ultrasonic tool 336 (e.g., its anchor channel 318) may be used to press portions of implant 20 and / or sleeve 30 against tissue site 68.

[0205] 4, the ultrasonic transceiver 338 is shaped as a ring that defines a passageway 56 therethrough (although other shapes and configurations are possible). The distal aperture 319 of the ultrasonic tool 336 may be defined by the channel 318, but may alternatively or additionally be defined by the transceiver 338. The passageway 56 may be contiguous with the longitudinal cavity 50. In some applications, the passageway 56 has an inner diameter that is 80 percent or more (e.g., 90 percent or more) larger than the inner diameter of the cavity 50. For example, the inner diameter of the passageway 56 may be approximately the same size as the inner diameter of the cavity 50.

[0206] 5A-5J, which are schematic illustrations showing tool 308 being used to deploy implant 20 in cardiac tissue 92 of heart 90, according to some applications of the present invention.

[0207] 5A-5B, the ultrasonic tool 336 may be positioned with the ultrasonic transmitter / receiver 338 located within the lumen 44 of the implant and facing the first portion 70a of the wall. As shown, moving the adjustment mechanism 40 from being collinear with the sleeve axis d12 (FIG. 5A) to being disposed alongside the sleeve 30 (FIG. 5B) may be accomplished similarly to that described with respect to tool 8, mutatis mutandis.

[0208] As shown in FIG. 5C , the ultrasonic tool 336 (e.g., its channel 318) can be used to clamp a portion 70 a (e.g., of the wall 28) of the implant 20 against a site 68 a of the tissue 92 and transmit ultrasonic energy 35 into the site (e.g., via the portion 70 a). The ultrasonic tool 336 can be considered to be “front-facing,” similar to the ultrasonic tool 36 of the delivery tool 8, despite the ultrasonic tool 336 being shaped as a ring. In some applications, the ultrasonic transceiver 338 defines a distal aperture 319 that can be used to press the portion 70 against the site 68 ( FIG. 5C ).

[0209] A notable point in the transition from FIG. 5B to FIG. 5C is that in delivery tool 308, the ultrasonic tool itself includes an anchor channel, so there is no step where the ultrasonic tool is advanced within the anchor channel.

[0210] FIG. 5D shows anchor driver 16, coupled to tissue anchor 52, advanced through longitudinal cavity 50 and passageway 56 so that tissue anchor 52 reaches first portion 70a.

[0211] Also notable in the transition from Figure 5C to Figure 5D is the absence of a step in which ultrasonic tool 336 is withdrawn before advancing anchor driver 16 toward portion 70a. Because ultrasonic tool 336 includes anchor channel 318 and passageway 56 is a distal portion of cavity 50, anchor driver 16 can be advanced through the cavity defined by the ultrasonic tool, eliminating the need for prior removal of the ultrasonic tool. Tissue anchor 52 is driven through passageway 56 (and optionally through portion 70a) into site 68a (Figure 5E).

[0212] In contrast to delivery tool 8, delivery tool 308 allows both the ultrasonic tool 336 and the anchor driver 16 to be simultaneously disposed at a location or site. In some applications, both the ultrasonic tool 336 and the anchor driver 16 may be simultaneously disposed within the lumen 44 of implant 20. Thus, delivery tool 308 eliminates the need to alternately advance either the ultrasonic tool 336 or the anchor driver 16. Advantageously, this configuration allows for the use of the ultrasonic tool and anchor driver together or simultaneously, e.g., to use the ultrasonic tool as the anchor driver deploys the anchor against tissue at a site to visualize the entry and placement of the anchor into tissue, etc. The ultrasonic tool and anchor driver may be configured coaxially with each other as they are used together (and optionally, the tissue anchor can be coaxial with the distal region or end of the ultrasonic tool and / or transceiver). This may aid in improved visualization and / or deployment of the anchor against tissue.

[0213] In some applications, delivery tool 308 may be used to anchor one or more additional portions 70 of wall 28 to additional regions of tissue 92, similar to that described with reference to delivery tool 8 of FIGS. 2G-2K. FIG. 5F shows delivery tool 308 being used to eject second portion 70b of sleeve 30 from ultrasonic tool 336 to position second portion 70b at second anchoring site 68b before catheter distal portion 25 is repositioned ( FIGS. 5F-5H ). Often with delivery tool 308, as shown, second region 68b of tissue 92 is evaluated without removing ultrasonic transmitter / receiver 38 from within lumen 44 of implant 20 (i.e., without removing the ultrasonic transmitter / receiver between evaluation of first region 68a and evaluation of second region 68b).

[0214] 5I-5J show that the second tissue anchor 52b is advanced through the cavity 50 and passageway 56 using the anchor driver 16 and driven through the second portion 70b and into the second location 68b. Further, with the delivery tool 308, as shown, the second tissue anchor 52b can be driven through the second portion 70b of the wall 28 and into the second location 68b of the tissue 92, while the ultrasonic transmitter / receiver 38 remains within the lumen 44 of the implant 20 against the second portion of the wall.

[0215] The manner in which the implant can be contracted, for example by applying tension to contraction member 42, is largely unaffected by the differences between delivery tool 8 and delivery tool 308 described hereinafter in this specification, and therefore contraction can be achieved as described above with reference to delivery tool 8 of Figures 2L to 2M.

[0216] While the embodiments described and illustrated herein often relate to annuloplasty structures, such as annuloplasty bands, anchored to the annular tissue of a native heart valve, the methods, techniques, systems, devices, etc. disclosed herein relate, mutatis mutandis, to the anchoring of a variety of implants to a variety of tissues in a subject.

[0217] The devices, systems, methods, techniques, etc. disclosed herein can be used in combination with those described in U.S. Patent Application Publication No. 2018 / 0049875 to Iflah et al., International Patent Application No. PCT / IL2019 / 050777 to Brauon et al. (published as WO 2020 / 012481), U.S. Provisional Patent Application No. 62 / 949,392 to Kasher et al., and / or U.S. Patent No. 9,949,828 to Sheps et al., each of which is incorporated by reference in its entirety.

[0218] Reference is now made to FIG. 6, which is a flow diagram that generally illustrates at least some steps of an example method 200 for implanting an implant in tissue, according to some applications. In some applications, method 200 is performed using delivery tool 8 and / or delivery tool 308. In some applications, method 200 is utilized to implant an implant in cardiac tissue 92 of a subject's heart 90. In some applications, method 200 is performed on implant 20.

[0219] An implant (e.g., implant 20) having a wall surrounding a lumen is advanced to tissue, such as valve annulus 88, often within a delivery tool, such as delivery tool 8 or 308 (step 202). In some applications, an ultrasonic tool, such as ultrasonic tool 36 or 336, is then advanced into implant 20 (step 204). (Optionally, the ultrasonic tool may be present within the implant during advancement of the implant.) The delivery tool is maneuvered to a potential anchoring site (step 206), and a portion of the implant (e.g., a portion of the implant wall or sleeve) may be pressed against (e.g., held in abutment with) the site (step 208), e.g., as described above with reference to FIGS. 2C and 5C.

[0220] Ultrasonic energy may be transmitted (e.g., using ultrasonic transceiver 38 of ultrasonic tool 36 or ultrasonic transceiver 338 of ultrasonic tool 336) through a portion of the implant to the tissue site (step 210). A portion of the ultrasonic energy (e.g., ultrasonic energy reflected from the site and / or through the wall portion) is detected (step 212), as described with reference to FIG. 2C.

[0221] The tissue site is then evaluated (e.g., analyzed) for suitability as an anchoring site for anchoring the implant (step 214). For example, the site may be evaluated as described with reference to Figures 2C and 3A-3F. If evaluation of the site reveals that the site is unsuitable as an anchoring site, the delivery tool is steered to another potential anchoring site (step 204).

[0222] If evaluation of the site indicates that the site is suitable as an anchoring site, the previous portion of the implant is anchored to the site (step 218), such as with anchor driver 16, as described with reference to Figures 2E-2F. In some applications, the ultrasonic tool is withdrawn from the delivery tool before anchoring the portion of the wall to the tissue site, as described with reference to Figure 2D (optionally, the portion is anchored to the site with an ultrasonic transmitter / receiver disposed within the lumen of the implant, and optionally with the ultrasonic tool or ultrasonic transmitter / receiver used for imaging, as described with reference to Figures 5D-5E).

[0223] If additional portions of the wall and / or additional sites of tissue are identified as desirable for anchoring (step 220), the delivery tool is steered to other potential anchoring sites (step 206). For example, as described with reference to Figures 2E-2K, multiple tissue anchors 52 may be used to anchor the implant to tissue.

[0224] If any additional portions of the wall and / or any additional sites of tissue are identified as undesirable for anchoring (step 220), the implant (e.g., implant 20) may be contracted, for example, by applying tension to contraction member 42, as described, for example, with reference to Figures 2L-2M.

[0225] 7A-7B, which are schematic illustrations of an example system 120 including an indicator wire 124 configured to be placed within a blood vessel 122 of a subject's heart 90. The indicator wire 124 may be positioned within a coronary artery or vein (such as the coronary sinus as shown) for applications in which treatment of a mitral valve 86 is desired. Note that the indicator wire 124 may be placed within any suitable blood vessel of the heart. As shown, the wire 124 is positioned adjacent the annulus 88 of the valve 86 to guide a distal portion of the anchor delivery system 128 toward an appropriate location along the annulus 88 for deploying tissue anchors 52 in the annulus 88. The system 120 provides an indication of the location of the distal end of the anchor delivery system 128 so that the anchor is properly deployed within the tissue 92 of the annulus 88 and is not unintentionally deployed within the valve leaflet tissue, the arterial wall, or any other undesired tissue.

[0226] System 120 is for treating a native valve (e.g., an atrioventricular valve, such as the mitral valve or tricuspid valve) of a subject's heart 90. Any of the methods, techniques, acts, steps, etc. described herein using system 120 can be performed on a living animal or on a non-living simulation, such as a cadaver, cadaver heart, simulator (e.g., a body part, heart, tissue, etc. being stimulated), etc.

[0227] The indicator wire 124 can be configured to generate a physical field 126 relative to the wire 124, such as the surrounding wire 124. In some applications, the indicator wire 124 is coupled to an electrical wire that passes a current through the indicator wire 124. In some applications, the field 126 includes an electric field. In some applications, the field 126 includes an electrostatic field. In some applications, the field 126 includes an electromagnetic field. In some applications, the field 126 includes a magnetic field. The indicator wire 124 is charged with an electrostatic potential or has a current flowing through it to increase its electromagnetic signature.

[0228] For some applications, the multi-component system 10 described herein above includes an anchor delivery system 128. As described herein above, the system 10 is used to deliver and anchor an implant 20, such as an annuloplasty structure, in place. The structure includes a sleeve 30 defining a lumen 48 through which an anchor channel 18 of the multi-component tubular system 10 passes. A distal end portion of the anchor delivery system 128 comprises a distal end portion of the channel 18. The distal end portion of the channel 18 comprises a sensing element 130. For some applications, the sensing element 130 has a ring shape, as shown. For some applications, the sensing element 130 is shaped to define any other suitable shape. For some applications, the sensing element 130 comprises an antenna. For some applications, the implant 20 comprises the sensing element 130. For some applications, the sensing element 130 comprises an ultrasound sensing element.

[0229] In some applications, sensing elements 130 wirelessly transmit data about physical field 126 to an external processing unit and / or an external monitor (e.g., for analysis, visual display, etc.). In some applications, sensing elements are coupled to wires that transmit data about physical field 126 to an external processing unit and / or an external monitor.

[0230] As shown in FIG. 7B , anchor delivery system 128 delivers tissue anchor 52 toward a portion of tissue 92 of annulus 88 adjacent blood vessel 122. Anchor driver 16 is used to deliver anchor 52 and anchor it to tissue 92. FIG. 7B shows anchor 52 after it has been deployed in tissue. Prior to deployment, a distal portion of anchor delivery system 128, i.e., the distal portion of channel 18 containing sensing element 130, is positioned within range of indicator wire 124 and in contact with field 126. That is, physical field 126 of wire 124 remains stationary while channel 18 moves.

[0231] The position of the distal portion of system 128 is determined by measuring the change in physical field 126 by placing the distal portion of anchor delivery system 128 within range of indicator wire 124 and calculating the distance between this portion of anchor delivery system 128 and a portion of indicator wire 124. That is, the change in field 126, as shown in FIG. 7B, is displayed, measured, and calculated and compared to the unstrained field 126 of wire 124, as shown in FIG. 7A. The amount of strain correlates to the distance between the distal end of channel 18 and wire 124. If this distance is below a predetermined threshold, indicating a proper position along the valve annulus 88 (i.e., not along undesirable tissue such as the valve leaflets or arterial wall), then anchor 52 is deployed.

[0232] Often, calculating the distance between this portion of anchor delivery system 128 and this portion of indicator wire 124 involves comparing this distance to a predetermined threshold, which may be correlated to an amount of strain in physical field 126. System 120 provides an indication to the operating physician when the proximity between sensing element 130 and wire 124 reaches the predetermined threshold.

[0233] In response to comparing the distance to a predetermined threshold, an anchor 52 is deployed within the tissue 92 of the valve annulus 88. In some applications, a tissue anchor 52 is deployed in response to determining that the distance is less than the predetermined threshold. Once the anchor 52 is deployed in the appropriate location along the valve annulus 88, the channel 18 of the anchor delivery system 128 is moved along the annulus 88 to the anchor portion of the tissue 92, and another strain in the field 126 is measured to calculate the distance between the distal end portion of the channel 18 and the wire 124. If the distance is less than the threshold, another anchor 52 is deployed within the tissue 92 of the valve annulus.

[0234] In some applications, sensing element 130 comprises an ultrasonic sensing element. In applications in which sensing element 130 comprises an ultrasonic sensing element, indicator wire 124 may or may not generate physical field 126. Rather, the ultrasonic sensing element generates an ultrasonic field, and when channel 18 comes within range of indicator wire 124, a change in the ultrasonic field generated by the ultrasonic sensing element due to the proximity of wire 124 is monitored and calculated to determine whether the distance between the distal end of channel 18 and wire 124 is less than a predetermined threshold.

[0235] That is, the ultrasonic field in the channel 18 moves while the wire 124 remains stationary.

[0236] 7A-7B, it should be noted that the system 120 may also be used to treat the right side of the heart. In applications where the implant 20 is placed along the tricuspid valve, the wire 124 may be positioned within the right coronary artery.

[0237] 7A-7B, system 120 advantageously provides the surgeon with better guidance regarding the location of the portions of anchor delivery system 128 relative to the artery or vein, thus minimizing or eliminating the possibility of damaging the vessel during anchor delivery. System 120 thus improves patient safety and reduces procedure time.

[0238] Referring again to Figures 7A-7B, in some applications, systems 10 and 120 are used in combination with one or more techniques described in one or more of the following references, all of which are incorporated herein by reference for all purposes: Furthermore, the techniques, methods, acts, steps, etc. described or suggested in this disclosure and / or the following references may be implemented on live animals or on non-living simulations, such as cadavers, cadaver hearts, simulators (e.g., stimulated body parts, hearts, tissues, etc.), etc.

[0239] U.S. Patent Application No. 12 / 437,103 to Zipory et al., filed May 7, 2009, published as U.S. Patent Application Publication No. 2010 / 0286767. For example, (1) systems 10 and 120 herein may be used, mutatis mutandis, to facilitate the techniques described with reference to Figures 2-3 and / or 6A-12 of Zipory et al., U.S. Patent Application Publication No. 2010 / 0286767. (2) anchor driver 16 herein may comprise or correspond to anchor driver 68 and / or anchor deployment manipulator 24 of Zipory et al., U.S. Patent Application Publication No. 2010 / 0286767, mutatis mutandis. (3) the tissue anchor 52 herein may comprise, mutatis mutandis, or be equivalent to the anchor 38 of Zipory et al., U.S. Patent Application Publication No. 2010 / 0286767, and / or (4) the implant herein may comprise, mutatis mutandis, or be equivalent to the annuloplasty ring 22 of Zipory et al., U.S. Patent Application Publication No. 2010 / 0286767.

[0240] U.S. Patent Application No. 12 / 689,635 to Zipory et al., filed January 19, 2010, published as U.S. Patent Application Publication No. 2010 / 0280604. For example, (1) systems 10 and 120 herein may be used, mutatis mutandis, to facilitate the techniques described with reference to Figures 2-3 and / or 11A-17 of Zipory et al. U.S. Patent Application Publication No. 2010 / 0280604. (2) anchor driver 16 herein may comprise or correspond to anchor driver 68 and / or anchor deployment manipulator 24 of Zipory et al. U.S. Patent Application Publication No. 2010 / 0280604, mutatis mutandis. (3) the tissue anchor 52 herein may comprise, mutatis mutandis, or be equivalent to the anchor 38 of Zipory et al., U.S. Patent Application Publication No. 2010 / 0280604, and / or (4) the implant herein may comprise, mutatis mutandis, or be equivalent to the annuloplasty ring 22 of Zipory et al., U.S. Patent Application Publication No. 2010 / 0280604.

[0241] International Patent Application No. PCT / IL2012 / 050451 to Sheps et al., filed November 8, 2013, published as WO 2013 / 069019. For example, (1) systems 10 and 120 herein may be used, mutatis mutandis, to facilitate the techniques described with reference to FIGS. 14A-14I of Sheps et al. WO 2013 / 069019. (2) systems 10 and 120 herein may comprise, mutatis mutandis, or be equivalent to system 10 of Sheps et al. WO 2013 / 069019. (3) anchor driver 16 herein may comprise, mutatis mutandis, anchor deployment manipulator 61 and / or anchor driver 36 of Sheps et al. WO 2013 / 069019. and / or (4) the implants herein may comprise, mutatis mutandis, annuloplasty structure 222 and / or sleeve 26 of Sheps et al., International Publication No. 2013 / 069019, or may be equivalent thereto.

[0242] International Patent Application No. PCT / IL2013 / 050860 to Sheps et al., entitled "Controlled steering functionality for implant-delivery tool," filed October 23, 2013, published as WO 2014 / 064694. For example, (1) systems 10 and 120 herein may be used, mutatis mutandis, to facilitate the techniques described with reference to Figures 10A-10I, 12A-14B, 18A-18C, 21-28, 34, and 36 of this PCT application entitled "Controlled steering functionality for implant-delivery tool." (2) systems 10 and 120 herein may comprise or be equivalent to system 10 of this PCT application entitled "Controlled steering functionality for implant-delivery tool," mutatis mutandis. (3) the anchor driver 16 herein may comprise, mutatis mutandis, or be equivalent to the anchor deployment manipulator 61, anchor driver 36, and / or deployment element 2338 of this PCT application entitled "Controlled steering functionality for implant-delivery tool," and / or (4) the implant herein may comprise, mutatis mutandis, or be equivalent to the annuloplasty structure 222 and / or sleeve 26 of this PCT application entitled "Controlled steering functionality for implant-delivery tool."

[0243] International Patent Application No. PCT / IL2013 / 050861 to Herman et al., entitled "Percutaneous tissue anchor techniques," filed October 23, 2013, published as WO 2014 / 064695. For example, (1) systems 10 and 120 herein may be used, mutatis mutandis, to facilitate the techniques described with reference to Figures 9A-9C and / or 13A-13D of this PCT application entitled "Percutaneous tissue anchor techniques." (2) tissue anchor 52 herein may comprise or correspond to tissue anchor 40 of this PCT application entitled "Percutaneous tissue anchor techniques," mutatis mutandis. and / or (3) anchor driver 16 herein may comprise or be equivalent to anchor driver 500, anchor driver 236, deployment manipulator 261, or tool 80 of this PCT application entitled “Percutaneous tissue anchor techniques,” mutatis mutandis.

[0244] Patent Application No. PCT / IL2019 / 050777 to Brauon et al., entitled "Annuloplasty Systems and Locking Tools Therefor," filed July 11, 2019, published as WO 2020 / 012481.

[0245] U.S. Provisional Patent Application No. 62 / 949,392 to Kasher et al., entitled "Annuloplasty and Tissue Anchor Technologies," filed December 17, 2019.

[0246] It will be appreciated by those skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove, but rather the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications that are not within the prior art, as would occur to one skilled in the art upon reading the above description. [Additional note 1] 1. A system for use with tissue of a subject, comprising: an implant having a wall surrounding a lumen; A delivery tool comprising: a catheter transluminally advanceable to the tissue and having a distal portion with a distal opening, the implant configured to be delivered to the tissue via the catheter; and an extracorporeal control assembly, configured to advance at least a portion of the wall out of the distal opening; a distal end portion operatively coupled to the distal portion for manipulating the distal portion to place the portion of the wall in abutment against the tissue site, the site being disposed distally from the portion of the wall and on an opposite side of the distal opening; an extracorporeal control assembly; an ultrasonic tool, advanceable within the catheter; an ultrasonic transceiver at a distal end of the ultrasonic tool; configured to position the ultrasound transmitter / receiver within the lumen of the implant facing the portion of the wall; configured to facilitate imaging of the site by transmitting ultrasonic energy through the portion of the wall and into the site. Ultrasonic tools; a delivery tool comprising: Tissue anchors, an anchor driver configured to drive the tissue anchor through the portion of the wall and into the site, thereby anchoring the implant to the tissue; A system comprising: [Additional note 2] 2. The system of claim 1, wherein the catheter is configured to be advanceable transfemorally and transseptally into the tissue. [Additional note 3] 3. The system of claim 1 or 2, wherein the distal portion of the catheter is radiopaque. [Additional note 4] 4. The system of any one of claims 1 to 3, wherein the anchor driver is configured to advance the tissue anchor through the catheter to the implant while the implant is disposed in the tissue. [Additional note 5] the ultrasonic transceiver is configured to detect reflected ultrasonic energy, the reflected ultrasonic energy being a portion of the ultrasonic energy transmitted by the ultrasonic transceiver and reflected from the site; The ultrasonic tool comprises: an ultrasound controller comprising circuitry and a user interface configured to facilitate analysis of the reflected ultrasound energy detected by the ultrasound transceiver; a connector configured to relay data representing the reflected ultrasonic energy detected by the ultrasonic transceiver from the ultrasonic transceiver to the ultrasonic controller; The system of any one of claims 1 to 4, further comprising: [Additional note 6] The system of claim 5, wherein the ultrasonic transmitter / receiver is configured to detect reflected ultrasonic energy reflected from the site through the portion of the wall. [Additional note 7] The delivery tool further comprises an anchor channel, the anchor channel comprising: defining a longitudinal cavity terminating in a distal aperture; a distal region of the anchor channel including the distal aperture extends through the catheter such that the distal region is disposed within the lumen; 7. The system of any one of clauses 1 to 6, wherein the system is advanceable through the catheter and the lumen. [Additional note 8] The anchor channel a distal region of the anchor channel disposed within the lumen, the distal region comprising the distal aperture; The anchor channel facilitates positioning of the portion of the wall at the site. The system of claim 7, wherein the catheter is configured to extend through the catheter. [Additional note 9] The anchor driver a tissue anchor coupled thereto and advanceable through the longitudinal cavity to the implant to advance the tissue anchor into the lumen of the implant in a manner such that the tissue anchor reaches the portion of the wall; 8. The system of claim 7, wherein the catheter is removable from the longitudinal cavity via a proximal opening. [Additional Note 10] The ultrasonic transmitter / receiver includes: the ultrasonic transmitter / receiver is advanceable through the longitudinal cavity and into the lumen of the implant so that the ultrasonic transmitter / receiver faces the portion of the wall; 10. The system of claim 9, wherein the catheter is removable from the longitudinal cavity through the proximal opening. [Additional Note 11] 11. The system of claim 10, wherein the anchor driver is advanceable through the longitudinal cavity to the implant only if the ultrasonic transmitter / receiver is not disposed through the longitudinal cavity. [Additional Note 12] the ultrasonic tool includes the anchor channel; the ultrasonic transmitter / receiver is disposed in the distal region of the anchor channel; 10. The system of claim 9, wherein the anchor channel is configured to position the ultrasound transmitter / receiver within the lumen of the implant and facing the portion of the wall. [Additional Note 13] 13. The system of claim 12, wherein the ultrasonic transmitter / receiver is shaped as a ring, the ring defining a passageway therethrough. [Additional Note 14] 14. The system of claim 13, wherein the anchor driver, when coupled to the tissue anchor, is advanceable through the longitudinal cavity to the implant to advance the tissue anchor through the passage in a manner such that the tissue anchor reaches the portion of the wall. [Additional Note 15] 15. The system of any one of clauses 1 to 14, wherein the implant includes an annuloplasty structure, the annuloplasty structure comprising a sleeve defined by the wall portion. [Additional Note 16] the annuloplasty structure further comprises a contraction member and an adjustment mechanism; the adjustment mechanism is configured to apply tension to the contraction member when actuated; 16. The system of claim 15, wherein the contraction member is configured to adjust the length of the annuloplasty structure when tensioned by actuating the adjustment mechanism. [Additional Note 17] placing an indicator wire within a blood vessel of the non-biological simulated heart; delivering a tissue anchor toward a portion of the cardiac tissue adjacent the blood vessel using an anchor delivery system, the anchor delivery system including an ultrasound sensing element in a portion of the anchor delivery system; determining a position of the portion of the anchor delivery system, measuring a change in the ultrasound field generated by the ultrasound sensing element due to positioning the portion of the anchor delivery system within range of the indicator wire; - calculating a distance between the portion of the anchor delivery system and a portion of the indicator wire from the measurement; and determining the A method comprising: [Additional Note 18] the portion of tissue includes tissue of the non-biological simulated valve annulus; The method further includes advancing an annuloplasty structure to the annulus, the annuloplasty structure shaped to define a lumen therethrough; 18. The method of claim 17, wherein the step of delivering the tissue anchor to the portion of tissue includes delivering the tissue anchor from within the lumen of the annulus plasty structure to a portion of the tissue of the annulus. [Additional Note 19] 19. The method of claim 17 or 18, wherein the step of delivering the tissue anchor includes a step of implanting an annuloplasty structure into the heart annulus using the tissue anchor. [Additional Note 20] 20. The method of claim 19, wherein the annuloplasty structure is shaped to define a lumen, and the step of delivering the tissue anchor includes moving the portion of the anchor delivery system through the lumen of the annuloplasty structure and deploying the tissue anchor from within the lumen of the annuloplasty structure into the portion of tissue. [Additional Note 21] 21. The method of any one of clauses 17 to 20, wherein calculating the distance between the portion of the anchor delivery system and the portion of the indicator wire includes comparing the distance to a predetermined threshold. [Additional Note 22] 22. The method of claim 21, wherein the step of delivering the tissue anchor includes deploying the tissue anchor into the portion of tissue in response to the comparison of the distance to a predetermined threshold and / or in response to a determination that the distance is less than the predetermined threshold. [Additional Note 23] The tissue anchor defines a first tissue anchor, and the method includes: after the step of deploying the tissue anchor in the portion of tissue, moving the portion of the anchor delivery system to a second portion of tissue by determining the position of the portion of the anchor delivery system; deploying a second tissue anchor into the second portion of tissue in response to the comparison of the distance to the predetermined threshold; 23. The method according to claim 22, further comprising: [Additional note 24] 24. The method of claim 23, wherein the step of deploying the second tissue anchor includes the step of deploying the second tissue anchor into the second portion of tissue in response to the determination that the distance is less than the predetermined threshold. [Additional note 25] 1. A method for implanting an implant into a tissue under simulation, comprising: - transluminally advancing the implant or a portion of the implant to the tissue using a delivery tool comprising a catheter, the catheter having a distal portion with a distal opening; - using a control assembly operatively coupled to the distal portion of the catheter to steer the distal portion of the catheter so that the distal opening is disposed at or near the tissue site; - positioning an ultrasonic transmitter / receiver of an ultrasonic tool at or near the site of the tissue; - assessing the site of the tissue by using the ultrasound tool, using the ultrasound tool to: transmitting ultrasonic energy to the site; detecting reflected ultrasound energy reflected from the site; thereafter anchoring the implant to the tissue by driving a tissue anchor to the site in the tissue using an anchor driver; A method comprising: [Additional note 26] the tissue comprises tissue of a heart valve annulus; the implant includes an annuloplasty structure having a lumen surrounded by a wall; evaluating the region of the tissue includes transmitting ultrasonic energy from within the lumen of the annuloplasty structure through the wall to the region using the ultrasonic transceiver; 26. The method of claim 25, wherein anchoring the implant to the tissue comprises anchoring a portion of the wall of the annulus-forming structure to the tissue of the annulus. [Additional note 27] 27. The method of claim 26, wherein detecting reflected ultrasound energy reflected from the site includes detecting reflected ultrasound energy that passes through the portion of the wall and is reflected back. [Additional note 28] the ultrasonic transceiver of the ultrasonic tool is disposed in a distal region of the ultrasonic tool; the portion of the wall is held against the site of tissue using the ultrasonic tool to apply a compressive force against the wall from within the lumen of the implant; 27. The method of claim 26, wherein driving the tissue anchor includes driving the tissue anchor through a passage defined by the ultrasonic transmitter / receiver. [Additional note 29] 29. The method of any one of clauses 25 to 28, wherein the anchor driver is coaxial with the ultrasonic tool when anchoring the implant to the tissue. [Additional note 30] 30. The method of claim 29, wherein the tissue anchor is coaxial with a distal region of the ultrasonic tool when anchoring the implant to the tissue. [Additional note 31] 31. The method of claim 29 or 30, further comprising the step of simultaneously using the ultrasonic tool and the anchor driver while anchoring the implant to the tissue. [Additional note 32] 31. The method of claim 29 or 30, further comprising anchoring the implant to the tissue by driving the tissue anchor into the portion of the tissue while continuing to evaluate the portion of the tissue using the ultrasound tool. [Additional note 33] the ultrasonic tool further comprises a connector and an ultrasonic controller comprising circuitry and a user interface; The method comprises: - relaying data representing the reflected ultrasonic energy detected by the ultrasonic transceiver from the ultrasonic transceiver to the ultrasonic controller using the connector; - analyzing the reflected ultrasonic energy using the circuitry of the ultrasonic controller; 33. The method of any one of clauses 25 to 32, further comprising: [Additional note 34] 34. The method of claim 33, wherein the step of analyzing the reflected ultrasonic energy includes a step of running a data analysis program in the circuit. [Additional note 35] 34. The method of claim 33, wherein the step of analyzing the reflected ultrasound energy includes a step of evaluating an image displayed on the user interface. [Additional note 36] the tissue anchor is a first tissue anchor; the portion of the tissue is a first portion of the tissue; driving the tissue anchor into the portion of the tissue includes driving the first tissue anchor into the first portion of the tissue; 36. The method of any one of clauses 25 to 35, wherein the step of anchoring the implant to the tissue further comprises driving a second tissue anchor into a second portion of the tissue different from the first portion of the tissue after driving the first tissue anchor into the first portion of the tissue. [Additional note 37] the implant comprises a contraction member; 37. The method of claim 36, further comprising adjusting the shape or size of the tissue by applying tension to the contraction member. [Additional note 38] the implant includes an annuloplasty structure having a wall shaped to define a sleeve of the annuloplasty structure, the annuloplasty structure including a constriction member extending along at least a portion of the sleeve; 37. The method of claim 36, further comprising adjusting the length of the annuloplasty structure by applying tension to the contraction member. [Additional note 39] 39. The method of claim 37 or 38, wherein applying tension to the contraction member comprises applying tension to the contraction member by actuating an adjustment mechanism. [Additional note 40] the adjustment mechanism includes a rotatable spool coupled to the retraction member; 40. The method of claim 39, wherein applying tension to the contraction member by actuating the adjustment mechanism includes rotating the spool. [Additional note 41] (i) after driving the first tissue anchor into the first portion of the tissue, and (ii) before driving the second tissue anchor into the second portion of the tissue; steering the distal portion of the catheter so that the distal opening is disposed at or near the second site of the tissue; evaluating the second section of the tissue using the ultrasound tool; transmitting ultrasonic energy to the second region using the ultrasonic tool; detecting reflected ultrasound energy reflected from the second location; The method according to claim 40, further comprising: [Explanation of symbols]

[0247] 8 Delivery Tools 10 Multi-component systems, multi-component tubular systems 16 Anchor Driver 18 Anchor Channel 19 Distal Aperture 20 Implants 22 Catheter 24 Distal region 25 distal portion 26 Distal opening 28 Wall 30 sleeves 34 distal end wall 35 Ultrasonic Energy 36 Ultrasonic Tools 37 Distal end 38 Ultrasonic Transceiver 40 operable adjustment mechanism 42 Flexible elongated contractile member 44 lumens 46 Flexible longitudinal guide member 47 Adjustment Tools 48 lumens 50 Longitudinal cavity 52 Anchor 52a first tissue anchor, first anchor 52b Second tissue anchor, second anchor 56 Passage 58 Blood vessels 60 User Interface 62 Distal portion 64 Extracorporeal Control Assembly 66 Coupling 68 sites, anchor fixation sites, tissue sites 68a First portion, first anchor fixing portion 68b Second portion, second anchor fixing portion 70 portions 70a First Part 70b Second part 72 connectors 74 Ultrasonic Controller 75 circuits 82 Handle 84 Steering Control Elements 86 Mitral valve 88 Valvular annulus 90 Heart 92 Heart tissue 120 System 122 Blood vessels 124 Indicator wire, perimeter wire 126 Physical field 128 Anchor Delivery System 130 Sensing element 308 Delivery Tools 310 Multi-Component System 318 Anchor Channel 319 Distal Aperture 336 Ultrasonic Tools 337 Distal end 338 Ultrasonic Transceiver d12 Implant axis, sleeve axis d14 channel axis

Claims

1. 1. A system for use with tissue of a subject, comprising: an implant comprising a wall surrounding a lumen; A delivery tool comprising: a catheter transluminally advanceable to the tissue and having a distal portion with a distal opening, the implant being configured to be delivered to the tissue via the catheter; an extracorporeal control assembly, configured to advance at least a portion of the wall out of the distal opening; a distal end portion operatively coupled to the distal portion for manipulating the distal portion to place the portion of the wall in abutment against the tissue site, the site being disposed distally from the portion of the wall and on an opposite side of the distal opening; an extracorporeal control assembly; an ultrasonic tool, advanceable within the catheter; an ultrasonic transceiver at a distal end of the ultrasonic tool; configured to position the ultrasound transmitter / receiver within the lumen of the implant facing the portion of the wall; configured to facilitate imaging of the site by transmitting ultrasonic energy through the portion of the wall and into the site. Ultrasonic tools; a delivery tool comprising: A system comprising:

2. The system of claim 1 , wherein the catheter is configured to be advanceable transfemorally and transseptally into the tissue.

3. The system of claim 1 or 2, wherein the distal portion of the catheter is radiopaque.

4. 4. The system of claim 1, further comprising a tissue anchor and an anchor driver, the anchor driver configured to advance the tissue anchor through the catheter to the implant with the implant disposed in the tissue.

5. the ultrasonic transceiver is configured to detect reflected ultrasonic energy, the reflected ultrasonic energy being a portion of the ultrasonic energy transmitted by the ultrasonic transceiver and reflected from the site; The ultrasonic tool comprises: an ultrasound controller comprising circuitry and a user interface configured to facilitate analysis of the reflected ultrasound energy detected by the ultrasound transceiver; a connector configured to relay data representing the reflected ultrasonic energy detected by the ultrasonic transceiver from the ultrasonic transceiver to the ultrasonic controller; The system of claim 1 , further comprising:

6. The system of claim 5 , wherein the ultrasound transceiver is configured to detect reflected ultrasound energy reflected from the site through the portion of the wall.

7. The delivery tool further comprises an anchor channel, the anchor channel comprising: defining a longitudinal cavity terminating in a distal aperture; a distal region of the anchor channel including the distal aperture extends through the catheter such that the distal region is disposed within the lumen; The system of claim 1 , wherein the system is advanceable through the catheter and the lumen.

8. The anchor channel a distal region of the anchor channel disposed within the lumen, the distal region comprising the distal aperture; The anchor channel facilitates positioning of the portion of the wall at the site. The system of claim 7 , wherein the catheter is configured to extend therethrough.

9. The method further includes a tissue anchor and an anchor driver, the anchor driver comprising: a tissue anchor coupled thereto and advanceable through the longitudinal cavity to the implant to advance the tissue anchor into the lumen of the implant in a manner such that the tissue anchor reaches the portion of the wall; The system of claim 7 , wherein the system is removable from the longitudinal cavity via a proximal opening in the catheter.

10. The ultrasonic transmitter / receiver includes: the ultrasonic transmitter / receiver is advanceable through the longitudinal cavity and into the lumen of the implant so that the ultrasonic transmitter / receiver faces the portion of the wall; The system of claim 9 , wherein the catheter is removable from the longitudinal cavity through the proximal opening.

11. 11. The system of claim 10, wherein the anchor driver is advanceable through the longitudinal cavity to the implant only if the ultrasound transmitter / receiver is not disposed through the longitudinal cavity.

12. the ultrasonic tool includes the anchor channel; the ultrasonic transmitter / receiver is disposed in the distal region of the anchor channel; 10. The system of claim 9, wherein the anchor channel is configured to position the ultrasound transmitter / receiver within the lumen of the implant and facing the portion of the wall.

13. The system of claim 12 , wherein the ultrasonic transceiver is shaped as a ring, the ring defining a passageway therethrough.

14. 14. The system of claim 13, further comprising a tissue anchor and an anchor driver, the anchor driver being advanceable through the longitudinal cavity to the implant when coupled to the tissue anchor to advance the tissue anchor through the passage in a manner such that the tissue anchor reaches the portion of the wall.

15. 15. The system of claim 1, wherein the implant includes an annuloplasty structure, the annuloplasty structure comprising a sleeve defined by the wall portion.

16. the annuloplasty structure further comprises a contraction member and an adjustment mechanism; the adjustment mechanism is configured to apply tension to the contraction member when actuated; 16. The system of claim 15, wherein the contraction member is configured to adjust the length of the annuloplasty structure when tensioned by actuating the adjustment mechanism.

17. 1. A system for use with tissue of a subject, comprising: an implant comprising a wall surrounding an internal cavity; A delivery tool comprising: a catheter transluminally advanceable to the tissue and having a distal portion with a distal opening, the implant being configured to be delivered to the tissue via the catheter; an extracorporeal control assembly, configured to advance at least a portion of the wall out of the distal opening; a distal end portion operatively coupled to the distal portion for manipulating the distal portion to place the portion of the wall in abutment against the tissue site, the site being disposed distally from the portion of the wall and on an opposite side of the distal opening; an extracorporeal control assembly; an imaging tool, advanceable within the catheter; a transceiver at a distal end of the imaging tool; configured to position the transceiver within the internal cavity of the implant facing the portion of the wall; configured to facilitate imaging of the site by transmitting energy through the portion of the wall and into the site. Imaging tools and a delivery tool comprising: A system comprising:

Images