Systems and methods for evaluating tissue quality

Abstract

A catheter (140, 240) has a distal opening that is configured to be transluminally advanced toward a tissue of a heart of a subject. A tissue-testing tool (110, 210) has a probe (114, 214), a shaft (120, 220), and an extracorporeal part that comprises a handle (146, 246) and a force meter (118, 218). The shaft links the extracorporeal part to the probe in a manner that facilitates: (i) advancement of the probe through the catheter, out of the distal opening, and into contact with the tissue, and (ii) transfer of a force from the handle to the probe while the probe is in contact with the tissue. While the probe is in contact with the tissue, the force meter provides an output indicative of a magnitude of a resistance, provided by the tissue, to movement of the probe responsive to the force applied to the handle.

Description

SYSTEMS AND METHODS FOR EVALUATING TISSUE QUALITYCROSS-REFERENCES TO RELATED APPLICATIONS

[0001] The present application claims priority from Provisional US Patent Application 63 / 673,750 to Morrison et al., filed July 21, 2024, and titled “Systems and methods for evaluating tissue quality,” which is incorporated herein by reference.BACKGROUND

[0002] A function of mammalian hearts is based on heart muscle contracting and creating pressure within ventricles of the heart, causing the blood to flow from the ventricles into arteries. Often, when the mammalian heart malfunctions, it can be repaired by insertion of various implants into the heart. Some such implants are anchored to tissue of the heart using tissue anchors having a head and a tissue-engaging element, for example in the shape of a helix or a dart.

[0003] Anchoring of implants to tissue using conventional tissue anchors has several limits or disadvantages. For example, the implant is excessively sized, and has excess components, because of the presence of metallic anchoring elements. Additionally, conventional tissue anchors provide a localized load to the tissue (e.g., based on anchor spacing). That localized load may exceed a limit of the tissue, or conversely may require large tissue anchors in order to distribute the load. Furthermore, some anatomical locations cannot tolerate the depth at which a tissue anchor extends into the tissue, and require surface-only adhesion. Such surface-only adhesion is difficult, if not impossible, to attain using tissue anchors.

[0004] There is thus a need for improved techniques and devices for evaluating the quality of a tissue at a potential anchoring site, to determine whether a tissue anchor can be securely driven into, and maintained, at the potential anchoring site.SUMMARY

[0005] This summary is meant to provide some examples and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the features. Also, the features, components, steps, concepts, etc. described in examples in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features andsteps as described elsewhere in this disclosure may be included in the examples summarized here.

[0006] In accordance with some implementations, a system for use in a real or simulated heart of a real or simulated subject includes a tissue-testing assembly. In some implementations, the tissue-testing assembly can include a probe adapted to contact tissue in the heart of the subject at a tissue site.

[0007] In some implementations, the tissue-testing assembly includes an extracorporeal measurement device adapted to provide a measure of a value indicative of a characteristic of the tissue at the tissue site.

[0008] In some implementations, the system further includes a catheter configured to be transluminally advanced toward the tissue site, such that the probe is adapted to be advanced to the tissue site through the catheter.

[0009] In some implementations, the system further includes an anchor driver. In some implementations, the anchor driver is advanceable through the catheter independently of the probe. In some implementations, the anchor driver is advanceable through the catheter together with the probe.

[0010] In some implementations, the anchor driver is adapted to drive a tissue anchor into tissue at the tissue site when the value of the characteristic of the tissues is within a predetermined range of values.

[0011] In accordance with some implementations, a system and / or an apparatus for use with a heart (e.g., real or simulated) of a subject (e.g., a living subject, simulation, etc.), includes a catheter, and / or a tissue-testing assembly. In some implementations, the catheter can be configured to be transluminally advanced toward an anatomical site of the subject. In some implementations, the catheter can have a proximal part and a steerable distal part.

[0012] In some implementations, the proximal part and steerable distal part have a catheter axis therebetween.

[0013] In some implementations, the tissue-testing assembly can include an extracorporeal handle. In some implementations, the extracorporeal handle includes a torque meter.

[0014] In some implementations, the tissue-testing assembly can include a probe.

[0015] In some implementations, the tissue-testing assembly can include a shaft. In some implementations, the shaft can be configured to transfer torque from the handle to the probe.

[0016] In some implementations, the probe can be disposed at a distal end of the shaft, and the handle can be disposed at a proximal end of the shaft.

[0017] In some implementations, the shaft can be adapted to be advanced through the catheter, to press the probe against a surface of a tissue at the anatomical site.

[0018] In some implementations, the handle can be configured such that, responsively to torque applied to the handle while the probe is pressed against the surface of the tissue, the tissue-testing assembly rotates the probe against the surface of the tissue while the tissue provides resistance to the rotation of the probe.

[0019] In some implementations, the torque meter provides an output indicative of a magnitude of the resistance.

[0020] In some implementations, the probe is shaped to define and / or comprise a protrusion (e.g., a fin, a wave, a paddle, a hexagon, etc.).

[0021] In some implementations, the shaft is configured to transfer torque from the handle to the fin, and to press the fin against the surface of the tissue at the anatomical site, and / or the handle is configured such that, responsively to torque applied to the handle while the fin is pressed against the surface of the tissue, (i) the tissue-testing assembly rotates the fin against the surface of the tissue while the tissue provides resistance to the rotation of the fin, and (ii) the torque meter provides an output indicative of a magnitude of the resistance.

[0022] In some implementations, the system / apparatus further includes an anchor drive through which the shaft and the probe of the tissue-testing assembly are advanceable to the heart of the subject.

[0023] In some implementations, a distal end of the anchor drive includes a retention mechanism, adapted to engage the probe (e.g., by snap fit engagement, friction engagement, mechanical engagement, locking engagement, etc.) when the probe is advanced distally out of the anchor drive, so as to prevent motion of the probe proximally relative to the anchor drive during twisting of the probe.

[0024] In some implementations, the anchor drive is engaged to the probe by snap fit engagement.

[0025] In some implementations, the tissue-testing assembly further includes a visual indicator mechanically coupled to the probe, the visual indicator adapted to provide to a user a visual indication of the resistance of the tissue to rotation of the probe.

[0026] In some implementations, the probe is pressed against the surface of the tissue at a measurement location. In some implementations, the system / apparatus further includes at least one tissue anchor adapted to be advanced distally through the catheter, and to be anchored to the tissue at the measurement location when the resistance of the tissue at the measurement location to rotation of the probe is greater than a predetermined threshold.

[0027] In accordance with some implementations, a method for use with a heart (e.g., real or simulated) of a subject (e.g., a living subject, simulation, etc.), includes advancing into the heart of the subject a needle electrode.

[0028] In some implementations, the needle electrode can be in electrical communication with an impedance-measurement device.

[0029] In some implementations the method comprises inserting the needle electrode into tissue at a first site in the heart.

[0030] In some implementations, while the needle electrode remains disposed in the tissue at the first site, the method comprises using the impedance-measurement device to obtain an impedance value of the tissue at the first site.

[0031] In some implementations, the method comprises determining whether the obtained impedance value of the tissue at the first site lies within a predetermined impedance range; and / or in response to the determining, treating the first site as an anchoring location or a nonanchoring location.

[0032] In some implementations, treating includes: if the obtained impedance value of the tissue at the first site lies within the predetermined impedance range, driving a tissue anchor into the tissue at the first site, and retracting the needle electrode from the tissue at the first site; whereas if the obtained impedance value of the tissue at the first site lies outside of the predetermined impedance range, moving the needle electrode from the first site to a second site in the heart, without having driven the tissue anchor into the tissue at the first site.

[0033] In some implementations, advancing of the needle electrode includes advancing a bipolar needle including a measurement electrode and a reference electrode.

[0034] In some implementations, the method further includes, prior to obtaining the impedance value, advancing a reference electrode to the tissue and placing the reference electrode on a surface of the tissue at the first site.

[0035] In some implementations, the advancing includes transluminally advancing the needle electrode into the heart of the subject via a catheter.

[0036] In some implementations, driving the tissue anchor into the tissue at the first site includes transluminally advancing an anchor driver and the tissue anchor into the heart of the subject via the catheter.

[0037] In some implementations, driving the tissue anchor into the tissue at the first site includes transluminally advancing an anchor driver and the tissue anchor into the heart of the subject via a second catheter.

[0038] In some implementations, retracting the needle electrode from the tissue includes retracting the needle electrode from the heart of the subject via the catheter.

[0039] In some implementations, the method further includes maintaining the catheter at the first site during the retracting of the needle electrode from the tissue at the first site and the driving of the tissue anchor into the tissue at the first site.

[0040] In accordance with some implementations, a system and / or an apparatus for use with heart (e.g., real or simulated) of a subject (e.g., a living subject, simulation, etc.jincludes a catheter. In some implementations, the system can include an impedance-measuring device. In some implementations, the system can include an anchor driver. In some implementations, the catheter can be configured to be transluminally advanced to an anatomical site of the subject (e.g., a heart of a subject, an organ of a subject, a cavity of a subject, etc.), and / or can have a proximal part and a steerable distal part.

[0041] In some implementations, the proximal part and steerable distal part have a catheter axis therebetween.

[0042] In some implementations, the impedance-measurement device can include a needle electrode, adapted to be advanced out of the catheter and inserted into a tissue site of the heart.

[0043] In some implementations, the impedance-measurement device can include a reference electrode.

[0044] In some implementations, the impedance-measurement device can be placeable in electrical communication with the needle electrode and with the reference electrode, and / or can be configured to measure an impedance value of the tissue site.

[0045] In some implementations, the anchor driver can be advanceable through the catheter independently of the impedance-measurement device, and / or can be configured to drive a tissue anchor into the tissue site. In some implementations, the anchor driver is advanceable through the catheter together with the probe.

[0046] In some implementations, the impedance-measurement device includes a bipolar needle housing the needle electrode and the reference electrode.

[0047] In some implementations, the reference electrode is separate from the needle electrode, and is adapted to be advanced into the heart of the subject distally out of the catheter and placed in contact with the tissue at the tissue site prior to measurement of the impedance value.

[0048] In some implementations, the needle electrode is adapted to be retracted from the tissue site of the heart prior to the anchor driver driving the tissue anchor into the tissue site.

[0049] In some implementations, the catheter is adapted to maintain its location at the tissue site during retraction of the needle electrode from the tissue site and driving of the tissue anchor into the tissue site.

[0050] In some implementations, the anchor driver is configured to drive the tissue anchor into the tissue site only when the impedance value measured by the impedance-measurement device at the tissue site is within a predetermined impedance range.

[0051] In accordance with some implementations, a method for use with a heart (e.g., real or simulated) of a subject (e.g., a living subject, simulation, etc.jincludes transluminally advancing into the heart of the subject a needle.

[0052] In some implementations, the needle is coupled to a measurement device.

[0053] In some implementations, the method includes inserting the needle into tissue at a first site in the heart or another anatomical site.

[0054] In some implementations, the method includes using the measurement device to obtain a value indicative of a characteristic of the tissue at the first site.

[0055] In some implementations, the method includes determining whether the obtained value lies within a predetermined range.

[0056] In some implementations, the method includes, in response to the determining, treating the first site as an anchoring location or a non-anchoring location.

[0057] In some implementations, treating includes: if the obtained value lies within the predetermined range, driving a tissue anchor into the tissue at the first site, and retracting the needle from the tissue at the first site; whereas if the obtained value lies outside of the predetermined range, moving the needle from the first site to a second site in the heart, without having driven the tissue anchor into the tissue at the first site.

[0058] In some implementations the needle includes a needle electrode, the advancing includes transluminally advancing the needle electrode, and the inserting includes inserting the needle electrode.

[0059] The measurement device can include an impedance-measurement device, the obtaining of the value can include obtaining an impedance value of the tissue at the first site. The determination can include determining whether the impedance value lies within a predetermined impedance range.

[0060] In some implementations, advancing of the needle includes advancing a bipolar needle including a measurement electrode and a reference electrode.

[0061] In some implementations, the method further includes, prior to obtaining the value, advancing a reference electrode to the tissue and placing the reference electrode on a surface of the tissue at the first site.

[0062] In some implementations the needle includes a probe needle, the transluminally advancing includes transluminally advancing the probe needle, and / or the inserting includes inserting the probe needle.

[0063] In some implementations, the measurement device includes a force-measurement device. In some implementations, obtaining of the value includes obtaining a force threshold (e.g., force required) for inserting and / or removing the probe needle from the tissue at the first site, and / or the determination includes determining whether the force lies within a predetermined force range.

[0064] In some implementations, the advancing includes transluminally advancing the needle into the heart of the subject via a catheter.

[0065] In some implementations, driving the tissue anchor into the tissue at the first site includes transluminally advancing an anchor driver and the tissue anchor into the heart of the subject via the catheter.

[0066] In some implementations, driving the tissue anchor into the tissue at the first site includes transluminally advancing an anchor driver and the tissue anchor into the heart of the subject via a second catheter.

[0067] In some implementations, retracting the needle from the tissue includes retracting the needle from the heart of the subject via the catheter.

[0068] In some implementations, the method further includes maintaining the catheter at the first site during the retracting of the needle from the tissue at the first site and the driving of the tissue anchor into the tissue at the first site.

[0069] In accordance with some implementations, a system and / or an apparatus for use with a heart (e.g., real or simulated) of a subject (e.g., a living subject, simulations, etc.jincludes a catheter. The system can include a measurement assembly. The system can include an anchor driver. The catheter can be configured to be transluminally advanced to an anatomical site of the subject, and / or can have a proximal part and a steerable distal part, and a catheter axis therebetween.

[0070] In some implementations, the measurement assembly can include a needle, adapted to be advanced out of the catheter and inserted into a tissue site of the heart. In some implementations, the measurement assembly can include a measurement device configured to obtain a value indicative of a characteristic of the tissue at the tissue site.

[0071] In some implementations, the anchor driver can be advanceable through the catheter independently of the measurement assembly. In some implementations, the anchor driver can be configured to drive a tissue anchor into the tissue site. In some implementations, the anchor driver is advanceable through the catheter together with the probe.

[0072] In some implementations, the needle includes a needle electrode, the measurement device includes an impedance-measurement device configured to obtain an impedance value of the tissue at the tissue site, and the measurement assembly further includes a reference electrode.

[0073] In some implementations, the measurement assembly includes a bipolar needle housing the needle electrode and the reference electrode.

[0074] In some implementations, the reference electrode is separate from the needle electrode, and is adapted to be advanced into the heart of the subject distally out of thecatheter and placed in contact with the tissue at the tissue site prior to measurement of the impedance value.

[0075] In some implementations, the needle includes a probe needle, and the measurement device includes a force-measurement device configured to obtain a force threshold (e.g., force required) for inserting and / or removing the probe needle from the tissue at the tissue site.

[0076] In some implementations, the probe needle includes a barbed needle.

[0077] In some implementations, the probe needle includes a screw probe adapted to be rotationally inserted into the tissue.

[0078] In some implementations, the needle is adapted to be retracted from the tissue site of the heart prior to the anchor driver driving the tissue anchor into the tissue site.

[0079] In some implementations, the catheter is adapted to maintain its location at the tissue site during retraction of the needle from the tissue site and driving of the tissue anchor into the tissue site.

[0080] In some implementations, the anchor driver is configured to drive the tissue anchor into the tissue site only when the value obtained by the measurement device at the tissue site is within a predetermined range.

[0081] In accordance with some implementations, a system and / or apparatus for use with a heart (e.g., real or simulated) of a subject (e.g., a living subject, simulation, etc.) includes advancing into the heart of the subject a probe needle. The the probe needle can be coupled to a force-measurement device.

[0082] In some implementations, the probe needle is inserted into tissue at a first site in the heart.

[0083] In some implementations, the force-measurement device is used to obtain a value of force threshold (e.g., force required) to insert and / or remove the probe needle from the tissue at the first site.

[0084] In some implementations, a determination is made whether the obtained value of the force lies within a predetermined force range; and / or in response to the determination, treating the first site as an anchoring location or a non-anchoring location.

[0085] In some implementations, treating includes: if the obtained value of the force lies within the predetermined force range, driving a tissue anchor into the tissue at the first site, and retracting the probe needle from the tissue at the first site; whereas if the obtained value of the force lies outside of the predetermined force range, moving the probe needle from the first site to a second site in the heart, without having driven the tissue anchor into the tissue at the first site.

[0086] In some implementations, the advancing of the probe needle includes advancing a barbed needle.

[0087] In some implementations, the advancing of the probe needle includes advancing a screw probe, and the inserting includes rotationally inserting the screw probe into the tissue.

[0088] In some implementations, the advancing includes transluminally advancing the probe needle into the heart of the subject via a catheter.

[0089] In some implementations, driving the tissue anchor into the tissue at the first site includes transluminally advancing an anchor driver and the tissue anchor into the heart of the subject via the catheter.

[0090] In some implementations, driving the tissue anchor into the tissue at the first site includes transluminally advancing an anchor driver and the tissue anchor into the heart of the subject via a second catheter.

[0091] In some implementations, retracting the probe needle from the tissue includes retracting the probe needle from the heart of the subject via the catheter.

[0092] In some implementations, the method includes maintaining the catheter at the first site during the retracting of the probe needle from the tissue at the first site. In some implementations, the method includes driving of the tissue anchor into the tissue at the first site.

[0093] In accordance with some implementations, a system and / or an apparatus for use with a heart (e.g., real or simulated) of a subject (e.g., a living subject, simulation, etc.) includes a catheter. In some implementations, the system can include a force-measurement assembly. In some implementations, the system can include an anchor driver. In some implementations, the catheter can be configured to be transluminally advanced toward the anatomical site of the subject.

[0094] In some implementations, the proximal part and steerable distal part have a catheter axis therebetween.

[0095] In some implementations, the force-measurement assembly can include a probe needle, adapted to be advanced out of the catheter and inserted into a tissue site of the heart. In some implementations, the force-measurement assembly can include a forcemeasurement device coupled to the probe needle.

[0096] In some implementations, the force-measurement assembly can be configured to measure a force threshold (e.g., force required) to insert and / or remove the probe needle from the tissue at the tissue site. The anchor driver can be advanceable through the catheter independently of the force-measurement assembly, and / or configured to drive a tissue anchor into the tissue site.

[0097] In some implementations, the probe needle includes a barb anchor.

[0098] In some implementations, the probe needle includes a screw probe adapted to be rotationally inserted into the tissue.

[0099] In some implementations, the probe needle is adapted to be retracted from the tissue site of the heart prior to the anchor driver driving the tissue anchor into the tissue site.

[0100] In some implementations, the catheter is adapted to maintain its location at the tissue site during retraction of the probe needle from the tissue site and driving of the tissue anchor into the tissue site.

[0101] In some implementations, the anchor driver is configured to drive the tissue anchor into the tissue site only when the force measured by the force-measurement device at the tissue site is within a predetermined force range.

[0102] In accordance with some implementations, a method for use with a heart (e.g., real or simulated) of a subject (e.g., a living subject, simulation, etc.) includes transluminally advancing into the heart of the subject a probe disposed at a distal end of a shaft.

[0103] In some implementations, a proximal end of the shaft can be connected to an extracorporeal handle.

[0104] In some implementations, the extracorporeal handle can include a torque meter. In some implementations, the shaft is adapted to transfer torque from the handle to the probe. In some implementations, the shaft is adapted to press the probe against a surface of a tissue at a tissue site in the heart.

[0105] In some implementations, the method further includes applying torque to the handle while the probe is pressed against the surface of the tissue at the tissue site, so as to rotate the probe against the surface of the tissue while the tissue provides resistance to the rotation of the probe. In some implementations, the method further includes, responsive to the application of torque, receiving an output from the torque meter, the output indicative of a magnitude of the resistance of the tissue to the rotation of the probe.

[0106] In some implementations, the probe includes a protrusion (e.g., a fin, a wave, a paddle, a hexagon, etc.).

[0107] In some such implementations, pressing the probe against the surface of the tissue at the tissue site includes pressing the fin against the surface of the tissue at the tissue site, and / or applying torque to the handle while the probe is pressed against the surface of the tissue at the tissue site includes applying torque to the handle while the fin is pressed against the surface of the tissue at the tissue site, so as to rotate the fin against the surface of the tissue while the tissue provides resistance to the rotation of the fin.

[0108] In some implementations, receiving the output from the torque meter includes receiving the output from a mechanical torque meter.

[0109] In some implementations, receiving the output from the torque meter includes receiving the output from an electronic torque meter.

[0110] In some implementations, receiving the output includes receiving a visual output including an indication of high resistance, moderate resistance, or low resistance of the tissue to rotation of the probe.[OHl] In some implementations, the advancing includes transluminally advancing the probe into the heart of the subject via a catheter.

[0112] In some implementations, the advancing includes transluminally advancing the probe into the heart of the subject via an anchor driver.

[0113] In some implementations, the method further includes responsive to receiving the output, treating the tissue site as an anchoring location or a non-anchoring location.

[0114] In some implementations, this treating can include: if the output is indicative of the resistance of the tissue at the tissue site to rotation of the probe being greater than a predetermined resistance threshold, driving a tissue anchor into the tissue at the tissue site, and retracting the probe from the tissue at the tissue site.

[0115] In some implementations, this treating can include: if the output is indicative of the resistance of the tissue at the tissue site to rotation of the probe not being greater than the predetermined resistance threshold, moving the probe from the tissue site to a second tissue site in the heart, without having driven the tissue anchor into the tissue at the tissue site.

[0116] In some implementations, driving the tissue anchor into the tissue at the tissue site includes transluminally advancing an anchor driver and the tissue anchor into the heart of the subject via the catheter.

[0117] In some implementations, retracting the probe from the tissue includes retracting the probe from the heart of the subject via the catheter.

[0118] In accordance with some implementations, a method for use with a heart (e.g., real or simulated) of a subject (e.g., a living subject, simulation, etc.) includes transluminally advancing into the heart of the subject a probe, the probe being coupled to an extracorporeal measurement device.

[0119] In some implementations, the probe is coupled to tissue at a first site in the heart. In some implementations, the measurement device is used to obtain a value indicative of a characteristic of the tissue at the first site.

[0120] In some implementations, the method includes determining whether the obtained value lies within a predetermined range.

[0121] In some implementations, the method can include, in response to the determining, treating the first site as an anchoring location or a non-anchoring location.

[0122] In some implementations, if the obtained value lies within the predetermined range, treatment can include driving a tissue anchor into the tissue at the first site, and retracting the probe from the tissue at the first site; whereas if the obtained value lies outside of the predetermined range, moving the probe from the first site to a second site in the heart, without having driven the tissue anchor into the tissue at the first site.

[0123] In accordance with some implementations, a system and / or an apparatus for use with a heart (e.g., real or simulated) of a subject (e.g., a living subject, simulation, etc.) includes a catheter. In some implementations, the system includes a tissue-testing assembly. In some implementations, the system includes an anchor driver. The catheter can be configured to be transluminally advanced toward an anatomical site of the subject. In some implementations, the catheter can have proximal part and a steerable distal part.

[0124] In some implementations, the proximal part and steerable distal part have a catheter axis therebetween.

[0125] In some implementations, the tissue-testing assembly can include a probe, adapted to be advanced out of a distal end of the catheter and to engage tissue at a tissue site of the heart.

[0126] In some implementations, the tissue-testing assembly can include a measurement device, operatively coupled to the probe, and configured to obtain from the probe a value indicative of a characteristic of the tissue at the tissue site.

[0127] In some implementations, the anchor driver can be advanceable through the catheter dependently or independently of the probe, and / or can be configured to drive a tissue anchor into the tissue site.

[0128] In some implementations, the characteristic is an electrical characteristic of the tissue, and / or the measurement device is configured to obtain, from the probe, a value indicative of the electrical characteristic of the tissue.

[0129] In some implementations, the characteristic is a mechanical characteristic of the tissue, and / or the measurement device is configured to obtain, from the probe, a value indicative of the mechanical characteristic of the tissue.

[0130] In some implementations, the probe includes a needle, configured to engage the tissue by penetrating the tissue.

[0131] In some implementations, the needle includes an electrode, the characteristic is impedance, and / or the measurement device is configured to output a value indicative of the impedance.

[0132] In some implementations, the needle is shaped to define one or more grips, the characteristic is a magnitude of mechanical resistance for insertion and / or retraction from the tissue, and / or the measurement device is configured to output a value indicative of the magnitude of resistance for insertion and / or retraction from the tissue.

[0133] In some implementations, the probe includes a fin, configured to engage the tissue by pressing against the surface of the tissue.

[0134] In some implementations, the tissue-testing assembly is configured to apply torque to the fin while the fin is pressed against the surface of the tissue, the characteristic is a magnitude of mechanical resistance of the tissue to rotation of the fin, and / or themeasurement device is configured to output a value indicative of the magnitude of resistance of the tissue to rotation of the fin.

[0135] In accordance with some implementations, a method for use with a heart (e.g., real or simulated) of a subject (e.g., a living subject, simulation, etc.jincludes transluminally advancing a distal end of a catheter into the heart; facing the distal end of the catheter to tissue at a first site in the heart; and / or to the tissue at the first site, contacting a probe protruding from the distal end of the catheter.

[0136] In some implementations, the method includes applying a mechanical force to the tissue at the first site using the probe.

[0137] In some such implementations, the method includes, using an extracorporeal measurement device operatively coupled to the probe, obtaining a value indicative of resistance of the tissue to the mechanical force.

[0138] In some implementations, the method can include determining whether the value is indicative of greater-than-threshold resistance; and / or responsively, to the step of determining, designating the first site as an anchoring site or a non-anchoring site.

[0139] In some implementations, this designating can include: if the value is indicative of greater-than-threshold resistance, while the distal end of the catheter remains facing the tissue at the first site, driving a tissue-engaging element of an anchor out of the distal end of the catheter and into the tissue at the first site; whereas if the value is not indicative of greater-than-threshold resistance, moving the distal end of the catheter to face tissue at another site in the heart without driving the tissue-engaging element of the anchor out of the distal end of the catheter and into the tissue at the first site.

[0140] In some implementations, contacting the probe to the tissue at the first site includes inserting a needle into the tissue at the first site.

[0141] In some implementations, contacting the probe to the tissue at the first site includes pressing a fin against a surface of the tissue at the first site.

[0142] In some implementations, the mechanical force is torque, and the value obtained is indicative of resistance of the tissue to the torque.

[0143] In some implementations, the mechanical force is a pulling force, and the value obtained is indicative of resistance of the tissue to the pulling force.

[0144] In accordance with some implementations, a method for use with a heart (e.g., real or simulated) of a subject (e.g., a living subject, simulation, etc.) includes transluminally advancing a distal end of a catheter into the heart, facing the distal end of the catheter to tissue at a site in the heart and / or to the tissue at the site, and / or contacting a probe protruding from the distal end of the catheter.

[0145] In some implementations, the method can include, using the probe, applying a mechanical force to the tissue at the site.

[0146] In some implementations, the method includes, using an extracorporeal measurement device operatively coupled to the probe, measuring a resistance of the tissue to the mechanical force.

[0147] In some implementations, responsively to determining that the measured resistance is greater than a threshold resistance, while the distal end of the catheter remains facing the tissue at the site: the probe can be withdrawn from the catheter, an anchor can be advanced through the catheter, and / or a tissue-engaging element of the anchor can be driven out of the distal end of the catheter and into the tissue at the site.

[0148] In some implementations, contacting the probe to the tissue at the site includes inserting a needle into the tissue at the site.

[0149] In some implementations, contacting the probe to the tissue at the site includes pressing a fin against a surface of the tissue at the site.

[0150] In some implementations, the mechanical force is torque, and measuring the resistance includes measuring the resistance of the tissue to the torque.

[0151] In some implementations, the mechanical force is a pulling force, and measuring the resistance includes measuring the resistance of the tissue to the pulling force.

[0152] Any of the above method(s) and any methods of using the systems, assemblies, apparatuses, devices, etc. herein can be performed on a living subject (e.g., human or other animal) or on a simulation (e.g., a cadaver, cadaver heart, imaginary person, simulator, etc.). With a simulation, the body parts can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, etc.) and can optionally comprise computerized and / or physical representations.

[0153] Any of the above systems, assemblies, devices, apparatuses, components, etc. can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure theyare safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of one or more systems, devices, apparatuses, components, etc. herein (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0154] The foregoing discussion will be understood more readily from the following detailed description when taken in conjunction with the accompanying Figures, in which:BRIEF DESCRIPTION OF THE FIGURES

[0155] Fig. 1 A is a schematic illustration of a system for testing and treatment of a tissue of the heart of a subject, based on impedance of the tissue, in accordance with some implementations;

[0156] Fig. IB is a schematic illustration of a variant of a needle electrode forming part of the system of Fig. 1A;

[0157] Fig. 2A is a schematic illustration of a system for testing and treatment of a tissue of the heart of a subject, based on resistance of the tissue to force, in accordance with some implementations;

[0158] Figs. 2B and 2C are schematic illustrations of two variants of a probe needle forming part of the system of Fig. 2A;

[0159] Fig. 3 is a schematic illustration of a system for testing and treatment of a tissue of the heart of a subject, based on resistance of the tissue to application of torque, in accordance with some implementations;

[0160] Figs. 4A-D are schematic illustrations of steps of use of the system of Fig. 3 for testing and treatment of tissue of the heart of a subject, in accordance with some implementations; and

[0161] Figs. 5A-D are schematic illustrations of steps of use of the system of Fig. 3 for testing and treatment of tissue of the heart of a subject, in accordance with some implementations.DETAILED DESCRIPTION

[0162] In the following description, various aspects of testing and treatment of tissue will be described. For the purpose of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the different aspects of the disclosure.However, it will also be apparent to one skilled in the art that the disclosure may be practiced without specific details being presented herein. Furthermore, well-known features can be omitted or simplified in order not to obscure the disclosure. Additionally, in order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some elements may not be explicitly identified in every drawing that contains that element.

[0163] It is to be understood that the scope of the invention is not limited in its implementation to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other implementations or of being practiced or carried out in various ways. Furthermore, it is to be understood that the phraseology and terminology employed in the disclosure is for the purpose of description and should not be regarded as limiting.

[0164] The present disclosure includes different variants of some elements. Variants of a given element typically have the same structure and / or function as each other except for any differences described. For any given element for which different variants are disclosed, the identical name is used for each variant, in order to denote that they are, in fact, variants the same given element. Unless stated otherwise, applications of the devices, systems, and techniques described herein can include any arrangement in which one variant of an element is substituted with another identically-named variant of that element. Furthermore, throughout the figures, suffixes are used to denote different variants of the same element. Unless stated otherwise, such variants can be substituted with each other, mutatis mutandis. That is, unless stated otherwise, any element having a given reference numeral can be substituted with any other element (e.g., any other variant of the element) having the same reference numeral, independent of any suffix.

[0165] For the purposes of this implementation, the term “subject” relates to any mammal, particularly humans.

[0166] For the purposes of this implementation, the term “cardiac tissue” relates to any tissue of the heart, and includes, for example, any wall of the heart and any tissue of any heart valve.

[0167] Tissue can be tested with various systems, devices, apparatuses, methods etc. herein. In some implementations, the tissue can be determined to be suitable for a tissue anchor. In some implementations, the tissue can be determined to be unsuitable for a tissue anchor. Insome implementations, the tissue can be determined to be suitable for certain types of tissue anchors, but not suitable for other types of tissue anchors. In some implementations, a tissue anchor (e.g., an optimal tissue anchor, a better tissue anchor, a particular tissue anchor, etc.) may be selected based on characteristics of the tissue (e.g., characteristics identified by probing the tissue, etc.)

[0168] Referring now to the drawings, Fig. 1A is a schematic illustration of an example system (or tool) 10 for testing and treatment of a tissue of the heart of a subject, based on impedance and / or other characteristics of the tissue, in accordance with some implementations, and Fig. IB is a schematic illustration of a variant of a needle electrode forming part of the system of Fig. 1A.

[0169] As seen in Fig. 1A, in some implementations, testing and treatment system 10 includes an impedance measurement assembly including a probe such as needle 13 (e.g., a probe needle, an electrode needle, a barbed needle, etc.). In some implementations, the needle 13 houses or comprises one or more of a measurement electrode 14, a reference electrode 16, and an impedance-measurement device 18. In some implementations, and as illustrated in Fig. 1 A, reference electrode 16 is separate from needle 13, and can comprise a surface electrode.

[0170] In some implementations, and as illustrated in Fig. IB, needle 13a is a bipolar needle, including a measurement electrode 14a as well as reference electrode 16a.

[0171] In some implementations, testing and treatment system 10 further includes a longitudinal catheter 40, advanced or advanceable into the heart of the subject. In the illustrated implementation, a distal part 42 of the catheter is advanced to an atrium (e.g., a left atrium) of the heart, to be positioned upstream of a tissue site 31 at the mitral valve 30. However, it is to be understood that other heart valves (e.g., the tricuspid valve) or portions of the heart can be similarly treated.

[0172] In some implementations, longitudinal catheter 40 also has an extracorporeal proximal part 44 including a handle 46. Distal part 42 of longitudinal catheter 40 is guidable to the tissue site, such as by being actively steerable itself (e.g., by being operatively coupled by one or more pullwires to proximal part 44, such as to a steering controller in handle 46), or by being passively guided and / or steered (e.g., by extending over or through another steerable element, such as an actively steerable catheter). A longitudinal axis extends between proximal part 44 and distal part 42 of catheter 40. Catheter 40 can be advanced tothe tissue site using any method known in the art, for example transluminally (e.g., via a vena cava and, if necessary, via the septum separating the atria of the heart) or intercostally.

[0173] As shown in frame A of Fig. 1A, a probe configured as needle 13, together with measurement electrode 14 and reference electrode 16 can be advanced to the heart of the subject, for example distally out of longitudinal catheter 40. In some implementations, impedance-measurement device 18 remains outside of the body of the subject, and is electrically coupled, or in electrical communication, with measurement electrode 14 and reference electrode 16 via one or more wires 20 extending through catheter 40.

[0174] In some implementations, a probe or needle 13 is inserted into tissue at tissue site 31. In some implementations, the tissue site is in the heart of the subject.

[0175] In some implementations a reference electrode 16 is suitably placed, such that impedance-measurement device 18 measures an impedance value of tissue at the tissue site based on readings of measurement electrode 14 and of reference electrode 16.

[0176] In some implementations, e.g., as illustrated in Fig. 1A, reference electrode 16 can be disposed at distal part 42 of catheter 40, e.g., at (such as circumscribing) the rim of the distal opening of the catheter. As such, when catheter 40 contacts the tissue at tissue site 31, reference electrode 16 is placed in contact with the tissue that surrounds needle 13 housing measurement electrode 14. However, it is to be appreciated that reference electrode 16 can be positioned to contact any suitable tissue surface, provided that the placement of the reference electrode facilitates measurement of the impedance value of the tissue at tissue site 31 by impedance-measurement device 18. In some implementations, electrode 16 is positioned so as to be out of contact with any tissue surface, but instead to rely on conductivity of the blood.

[0177] In some implementations, and as illustrated in Fig. IB, the probe or needle 13a can be a bipolar needle, such that measurement electrode 14a and reference electrode 16a are incorporated into needle 13a. In such implementations, when needle 13a is inserted into the tissue at tissue site 31, measurement electrode 14a and reference electrode 16a are both in contact with the tissue at the tissue site. In some implementations, reference electrode 16a is disposed at a more distal point of needle 13a than measurement electrode 14a. In some implementations, reference electrode 16a can be disposed at a more proximal point of needle 13 than measurement electrode 14a (e.g., as shown).

[0178] In some implementations, the reference electrode can be, or can be provided on, an additional needle, coaxially and / or telescopically disposed within needle 13 housing measurement electrode 14. In such implementations, the additional needle is adapted to be extended distally out of needle 13 and into the tissue, e.g., coaxially with needle 13.

[0179] In some implementations, with needle electrode 14 within the tissue, impedance measurement device 18 obtains an impedance measurement of the tissue at tissue site 31. Responsively to the measured impedance it is then determined whether or not the tissue at the location is suitable for receiving a tissue anchor. This determination can be performed by a medical practitioner reading the impedance measurement (e.g., outputted by impedance measurement device 18), or automatically by a processor functionally associated with the impedance measurement device. For example, the tissue can be determined to be suitable for receiving a tissue anchor if the impedance measurement lies within a predetermined impedance range. In some implementations, the tissue may be identified as suitable for some types of anchors, but not other types of anchors.

[0180] In some implementations, in response to such determination, tissue site 31 is identified and / or treated as either (i) an anchoring location (e.g., a location at which an anchor can and / or should be driven into the tissue); or (ii) a non-anchoring location (e.g., a location at which an anchor cannot / should not be driven into the tissue). In some implementations, a particular type of anchor may be selected according to the tissue characteristics.

[0181] In some implementations, a given tissue site can be identified and / or treated as an anchoring location or a non-anchoring location responsively to the measured impedance being indicative of certain characteristics of the tissue at the site such as, but not limited to: having sufficient strength and / or anchor-retentiveness; having sufficient depth; being of a particular tissue type (e.g., valve annulus tissue, atrial wall tissue, ventricular wall tissue, papillary muscle tissue); being not of a particular tissue type (e.g., valve leaflet tissue, chordae tendineae tissue); and / or being free from contraindicative structures (e.g., coronary blood vessels and / or conductive tissues).

[0182] In the example shown in Fig. 1A, tissue site 31 is identified and treated as an anchoring location. Therefore, a tissue anchor 50 is driven into tissue at tissue site 31, as illustrated in frames B and C of Fig. 1A.

[0183] In some implementations, tissue anchor 50 is driven into tissue site 31 by a driving tool or anchor driver 41 (e.g., as known in the art, mutatis mutandis). The driving tool can be advanced to the heart of the subject via a second catheter, similar to catheter 40, or via catheter 40. In some implementations, the driving tool is rotatable, and anchors tissue anchor 50 by screwing the tissue anchor into the tissue. Following anchoring of tissue anchor 50, the driving tool can be retracted from the heart of the subject, for example via the catheter through which the driving tool was introduced.

[0184] In some implementations, and as illustrated in frame B of Fig. 1A, tissue anchor 50 is driven into tissue site 31 while needle 13 is still disposed within the tissue, and / or while measurement electrode 14 and reference electrode 16 are still in contact with the tissue. For example, a helical tissue-engaging portion 52 of tissue anchor 50 can be driven into tissue site 31 about (e.g., coaxially to) needle 13. In some such implementations, needle 13 and measurement electrode 14 are subsequently retracted from the tissue at tissue site 31 and withdrawn from the subject, for example via catheter 40, following driving of tissue anchor 50 into the tissue. For example, needle 13 can be retracted along with the anchor driver.

[0185] In some implementations in which tissue anchor 50 is driven into tissue site 31 while needle 13 is still disposed within the tissue, anchor driver 41 is disposed coaxially around needle 13 and / or the conductor (e.g., wire) that extends from electrode 14 to device 18. In some implementations, needle 13 is a component of anchor driver 41 - anchor driver 41 is actuated to advance and retract the needle.

[0186] In some implementations, and in a similar manner to that described hereinbelow with respect to Fig. 2A, needle 13, measurement electrode 14, and / or reference electrode 16 can retracted from the tissue at tissue site 31, for example via catheter 40, prior to driving of tissue anchor 50 into the tissue. In some such implementations, catheter 40 is maintained stationary at tissue site 31 during the retraction of needle 13 and advancement and anchoring of anchor driver 41 and tissue anchor 50, for example to retain the precise location of tissue site 31 at which the impedance measurement value was obtained.

[0187] In some implementations, following driving of tissue anchor 50 into tissue at tissue site 31, catheter 40, together with measurement electrode 14 and reference electrode 16, can be advanced to another tissue site, for evaluation of the quality thereof.

[0188] When the obtained impedance value of the tissue at tissue site 31 lies outside of the predetermined impedance range, tissue site 31 is treated as a non-anchoring location. Assuch, needle 13, together with measurement electrode 14 and reference electrode 16, are moved to a second tissue site 54 within the heart of the user for evaluation of the quality thereof, without having driven a tissue anchor into tissue at tissue site 31.

[0189] Reference is now made to Fig. 2A, which is a schematic illustration of part of a system (or tool) 110 for testing and treatment of a tissue of the heart of a subject, based on resistance, or responsiveness, of the tissue to application of mechanical force, in accordance with some implementations, and to Figs. 2B and 2C, which are schematic illustrations of two variants of a probe needle forming part of system 110 of Fig. 2A.

[0190] As seen in Fig. 2A, testing and treatment system 110 includes a force measurement assembly including a probe needle 114 and a force-measurement device (or force meter) 118. In some implementations, and as illustrated in Fig. 2A, probe needle 114 is a barbed needle.

[0191] Fig. 2B illustrates a variant 114a in which the probe needle is a coiled or threaded needle, or a screw probe. Fig. 2C illustrates a variant 114b in which the probe needle includes one or more bulbs 115 along its length - instead of barbs. Whether barbs, bulbs, or coils / threads, these features of (or on) probe needle 114 and its variants can be referred to as grips, and are configured to grip the tissue to a known degree (e.g., to provide a known magnitude of resistance to retraction from the tissue).

[0192] In some implementations, testing and treatment system 110 further includes a longitudinal catheter 140, advanced or advanceable into the heart of the subject. In the illustrated example, a distal part 142 of the catheter is advanced to an atrium (e.g., a left atrium) of the heart, to be positioned upstream of a tissue site 131, for example located at the mitral valve 30. However, it is to be understood that other heart valves (e.g., the tricuspid valve) or portions of the heart can be similarly treated.

[0193] In some implementations, longitudinal catheter 140 also has an extracorporeal proximal part 144 including a handle 146. Distal part 142 of longitudinal catheter 140 is guidable to the tissue site, such as by being actively steerable itself (e.g., by being operatively coupled by one or more pullwires to proximal part 144, such as to a steering controller in handle 146), or by being passively guided and / or steered (e.g., by extending over or through another steerable element, such as an actively steerable catheter). A longitudinal axis extends between proximal part 144 and steerable distal part 142 of catheter 140. Catheter 140 can be advanced to the tissue site using any method known in the art, for example transluminally(e.g., via a vena cava and, if necessary, via the septum separating the atria of the heart) or intercostally.

[0194] As shown in frame A of Fig. 2 A, needle 114 is advanced to the heart of the subject, for example distally out of longitudinal catheter 140. In some implementations, forcemeasurement device 118 remains outside of the body of the subject, and is mechanically coupled to needle 114 via a shaft (e.g. comprising one or more wires or rods) 120 extending through catheter 140.

[0195] In some implementations, needle 114 is inserted into tissue at tissue site 131 in the heart of the subject (frame A). In some implementations, upon subsequent retraction of needle 114 from the tissue at the tissue site (frame B) force-measurement device 118 measures a retraction force threshold required to retract the needle from the tissue at the tissue site.

[0196] In some implementations, responsively to the measured retraction force, it is determined whether or not the tissue at the location is suitable for receiving a tissue anchor or a particular type of tissue anchor. This determination can be performed by a medical practitioner reading the retraction force measurement (e.g., outputted by force-measurement device 118), or automatically by a processor functionally associated with the forcemeasurement device. For example, the tissue can be determined to be suitable for receiving a tissue anchor (or a particular type of tissue anchor) if the retraction force measurement is greater than a threshold retraction force, or lies within a predetermined retraction force range.

[0197] In some implementations, in response to such determination, tissue site 131 is identified and / or treated as either (i) an anchoring location (e.g., a location at which an anchor can and / or should be driven into the tissue); or (ii) a non-anchoring location (e.g., a location at which an anchor cannot / should not be driven into the tissue).

[0198] A given tissue site can be identified and / or treated as an anchoring location or a nonanchoring location (e.g., for any tissue anchor or for a particular types of anchor) responsively to the measured retraction force being indicative of certain characteristics of the tissue at the site such as, but not limited to: having sufficient strength and / or anchor- retentiveness; having sufficient depth; being of a particular tissue type (e.g., valve annulus tissue); being not of a particular tissue type (e.g., valve leaflet tissue); and / or being free from contraindicative structures (e.g., coronary blood vessels and / or conductive tissues).

[0199] In the example shown in Fig. 2A, tissue site 131 is identified and treated as an anchoring location. Therefore, a tissue anchor 150 is driven into tissue at tissue site 131, as illustrated in frame C. Catheter 140 is maintained stationary at tissue site 131 during the retraction of needle 114 and advancement and anchoring of tissue anchor 150, for example to retain the exact location of tissue site 131 at which the retraction force measurement value was obtained.

[0200] In some implementations, tissue anchor 150 is driven into tissue site 131 by a driving tool or anchor driver (e.g., anchor driver 41), (e.g., as known in the art, mutatis mutandis). The driving tool can be advanced to the heart of the subject via a second catheter, similar to catheter 140, or via catheter 140, as shown in frame B of Fig. 2A. In some implementations, the driving tool is rotatable, and anchors tissue anchor 150 by screwing the tissue anchor into the tissue. Following anchoring of tissue anchor 150, the driving tool can be retracted from the heart of the subject, for example via the catheter through which the driving tool was introduced.

[0201] In some implementations, following driving of tissue anchor 150 into tissue at tissue site 131, catheter 140, together with needle 114, can be advanced to another tissue site, for evaluation of the quality thereof.

[0202] When the obtained force value of the tissue at tissue site 131 lies outside of the predetermined force range, tissue site 131 is treated as a non-anchoring location. As such, catheter 140 and needle 114 are moved to a second tissue site within the heart of the user for evaluation of the quality thereof, without having driven a tissue anchor into tissue at tissue site 131.

[0203] Reference is now made to Fig. 3, which is a schematic illustrations of an example system (or tool) 210 for testing a tissue of the heart of a subject, based on responsiveness of the tissue to application of mechanical force to the surface of the tissue, in accordance with some implementations.

[0204] As seen in Fig. 3, tissue-testing system 210 includes a tissue-testing assembly including an extracorporeal handle 212 comprising a torque meter 218 (i.e. a force meter), a probe, and a shaft 220 configured to transfer torque from handle 212 to the probe. The probe can comprise or consist of a protrusion 214. Protrusion 214 can take a variety of configurations / shapes; while the protrusion is sometimes described or referred to as a fin inexamples herein, other types and configurations / shapes of protrusions are possible in place of a fin (e.g., a wave, a paddle, a hexagon, etc.).

[0205] In some implementations, protrusion or fin 214 is disposed at the distal end of shaft 220, and handle 212 is disposed at the proximal end of shaft 220. In the example shown, the probe comprises a protrusion configured as a fin (or paddle) 214, but other configurations / shapes are possible.

[0206] In some implementations, fin 214 has a greater cross-sectional area in one longitudinal direction than in the opposing longitudinal direction. For example, fin 214 can include broad surfaces 214a, and a surrounding narrow surface 214b, shown in Fig. 3 as a curved, or substantially hemispherical, narrow surface.

[0207] In some implementations, fin 214 extends distally from a body 216 disposed at distal end of shaft 220. In some implementations, body 216 includes one or more indentations (e.g., circumferential grooves) 217 about a circumference thereof. As explained in further detail hereinbelow, fin 214 is adapted to be pressed against the surface of the tissue to be tested and, while thus pressed, to apply rotational force to the surface of tissue responsively to torque (e.g., applied at / via handle 212 and transferred to fin 214). Torque meter 218 is configured to measure the resistance of the tissue to the rotational force (e.g., resistance to twisting).

[0208] In some implementations, tissue-testing system 210 further includes a longitudinal catheter 240, advanceable into the heart of the subject. Catheter 240 terminates in a distal part 242, and has an extracorporeal proximal part, which can include a catheter handle (e.g., similar to handle 46 of Fig. 1 A). The catheter handle can be associated with handle 212.

[0209] In some implementations, distal part 242 of longitudinal catheter 240 is guidable to the tissue site, such as by being actively steerable itself (e.g., by being operatively coupled by one or more pullwires to the proximal part, such as to a steering controller in the catheter handle), or by being passively guided and / or steered (e.g., by extending over or through another steerable element, such as an actively steerable catheter). A longitudinal axis extends between proximal part and steerable distal part 242 of catheter 240. Catheter 240 can be advanced to the tissue site using any method known in the art, for example transluminally (e.g., via a vena cava and, if necessary, via the septum separating the atria of the heart) or intercostally. The characteristics described for catheter 240 can also apply to other catheters described herein, mutatis mutandis.

[0210] In some implementations, and as shown in Fig. 3, fin 214 protrudes distally out of distal part 242 of catheter 240, such that shaft 220 extends longitudinally through the catheter. In some implementations, while fin 214 extends distally out of catheter 240, at least a portion of body 216 is disposed within distal part 242 of the catheter. For some such implementations, the inner surface of distal part 242 of catheter 240 includes one or more protrusions 248 that protrude medially into the lumen of the catheter, and that are adapted for engagement (e.g., reversible snap-fit engagement) with at least one indentation 217 of body 216 at the end of shaft 220. Such engagement is adapted to inhibit relative axial movement between fin 214 and catheter 240, for example during advancement of the catheter and the fin to a desired location within the heart of the subject and / or during rotation of shaft 220 (e.g., relative to the catheter) during testing of the tissue - e.g. to allow the pressing of fin 214 against the tissue during its rotation without the fin withdrawing into the catheter. Thus, protrusion(s) 248 may define or serve as a retainer, configured to reversibly engage an intracorporeal part of tool 210 (e.g. probe 211 thereof) in a manner that inhibits axial movement (e.g. maintains an axial position) of the probe with respect to catheter 240 during evaluation of the tissue.

[0211] Indentation 217 may be a circumferential groove - e.g. as shown.

[0212] In some implementations, protrusions 248 can serve to control (e.g., can facilitate control of) advancement of anchors out of the distal end of catheter 240. In some such implementations, protrusions 248 can share features with the ribs / nubs / nodules described in International Patent Application PCT / IB2023 / 062298 to Halabi et al., filed December 6, 2023, and published as WO2024121770, which is incorporated herein by reference.

[0213] Torque meter 218 can be an electronic or mechanical torque meter, and can be mechanically and / or electrically coupled to fin 214 via shaft 220. In the example shown, torque meter 218 is a mechanical torque meter.

[0214] Torque meter 218 can include a visual indicator 250, adapted to provide to a user a visual indication of the resistance of the tissue to rotation of fin 214. For example, in the implementation shown in Fig. 3, visual indicator 250 includes a red portion (labeled R) indicative of low resistance of the tissue to twisting, a yellow portion (labeled Y) indicative of medium resistance of the tissue to twisting, and a green portion (labeled G) indicative of high resistance of the tissue to twisting. Visual indicator 250 is mechanically coupled to fin 214 via a neck portion 252 and via shaft 220.

[0215] In the implementation of Fig. 3, torque meter 218 of handle 212 further includes a bearing 254 associated with a ramp 256 disposed within handle 212. Ramp 256 is coupled to fin 214 via a base 258 of the handle, and via shaft 220, while bearing 254 can rotate relative to the ramp and relative to the shaft. A spring 260 is disposed between the bearing 254 and a ring 262 disposed about neck portion 252 and anchored to an exterior housing 264 of handle 212 by pins 265. Spring 260 has a known spring constant, and thereby provides resistance of a known magnitude to relative rotation between bearing 254 and ramp 256.

[0216] In some implementations, housing 264 of handle 212 includes a window 266 adapted to show a portion of visual indicator 250. Window 266 is rotatable relative to visual indicator 250, such that at different times different ones of the red, yellow, and green portions are visible within the window. Upon use of the torque meter, a specific one of the colored portions is visible within window 266, such that the color shown in the frame provides an indication to the user of the resistance of the tissue, pressed against fin 214, to twisting.

[0217] Reference is now made to Figs. 4A, 4B, 4C, and 4D, which are schematic illustrations of steps of use of example system 210 for testing and treatment of tissue of the heart of a subject, in accordance with some implementations. Figs. 4A to 4D generally illustrate a situation where a tested tissue site is determined to be an anchoring location, into which a tissue anchor can / should be driven, as explained herein.

[0218] As seen in Fig. 4A, in an initial, delivery, step, fin 214 and distal part 242 of longitudinal catheter 240 are advanced into the heart of the subject, while torque meter 218 remains outside of the body of the subject. In the illustrated implementation, distal part 242 of the catheter is advanced to an atrium (e.g., a left atrium, right atrium, etc.) of the heart, to be positioned upstream of a tissue site 231, for example located at the mitral valve 30. However, it is to be understood that other heart valves (e.g., the tricuspid valve, etc.) or portions of the heart can be similarly treated. As discussed hereinabove, the distal part of the catheter is guidable to the tissue site, such as by being actively steerable itself, or by being passively guided and / or steered, and can be advanced to the tissue site using any method known in the art, for example transluminally (e.g., via a vena cava and, if necessary, via the septum separating the atria of the heart) or intercostally.

[0219] In the delivery state of system 210, bearing 254 are at an initial position relative to ramp 256, as well as relative to ring 262, housing 264, and pins 265. In the example shownin Fig. 4A, one of pins 265 is substantially aligned with the red portion of visual indicator 250, and the red portion is visible through window 266.

[0220] Fin 214 (e.g., a narrow surface 214b thereof, etc.) is pressed against the surface of tissue at tissue site 231 (Fig. 4A). Subsequently, torque is applied to handle 212 (represented by arrow 270) while the fin remains pressed against the tissue (Fig. 4B). The torque applied to handle 212 is delivered to fin 214 via shaft 220. Arrow 272 represents fin 214, attempting to rotate (e.g., to slide rotationally over the surface of the tissue).

[0221] Fig. 4B represents the tissue substantially resisting rotational sliding of fin 214, the fin retaining its orientation relative to the tissue. Due to this resistance, responsively to the torque applied to handle 212 bearing 254 rotates and moves up ramp 256 (represented by arrows 274), stressing spring 260, and causing window 266 revealing the yellow (or green) portion of the visual indicator, as shown in the enlarged portion of Fig. 4B.

[0222] In response to an appropriate (e.g., yellow or green) portion of visual indicator 250 being visible through window 266, tissue site 231 is treated as an anchoring location. As such, a tissue anchor can be driven into tissue at tissue site 231. Stated differently, responsive to the measured resistance to torque, it is determined whether or not the tissue at the location is an anchoring location or a non-anchoring location. This determination can be performed by a medical practitioner reading the torque measurement (e.g., visible on torque meter 218), or automatically by a processor functionally associated with the torque meter (e.g., with an electronic torque meter).

[0223] In the situation shown in Figs. 4A to 4D, tissue site 231 is determined to be an anchoring location (e.g., a location at which an anchor can and / or should be driven into the tissue) or an anchoring location suitable for a particular type of anchor. It is to be understood that the complete absence of rotation of fin 214 is intended to be illustrative and that, even at high-resistance tissues, some rotation of the fin against the surface of the tissue can occur. Responsively to this determination, fin 214 is retracted (Fig. 4C) and a tissue anchor 280 is driven into tissue at tissue site 231 by a driving tool, or anchor driver (e.g., as known in the art, mutatis mutandis (Fig. 4D)). In some implementations, the driving tool is rotatable, and anchors the tissue anchor by screwing the tissue anchor into the tissue. Following anchoring of the tissue anchor, the driving tool can be retracted from the heart of the subject, for example via catheter 240. As shown in Figs. 4B-D, catheter 240 is maintained stationary at tissue site 231 during the retraction of fin 214 and introduction of the tissue anchor, forexample to retain the precise location of tissue site 231 that was determined to be an anchoring location.

[0224] Fig. 4D illustrates tissue site 231 following driving of tissue anchor 280 thereinto, for example via catheter 240.

[0225] In some implementations, following driving of tissue anchor 280 into tissue at tissue site 231, catheter 240, together with fin 214, can be retracted from tissue site 231 and advanced to another tissue site, for evaluation of the quality thereof.

[0226] Figs. 5A-C illustrate a situation in which the tested tissue site is determined to be a non-anchoring location (e.g., is unsuitable for having a tissue anchor driven thereinto) or unsuitable for a particular type of anchor (e.g., in some implementations, if a particular type of anchor is determined to be unsuitable relative to the tissue, then a different anchor can be selected and inserted instead).

[0227] Fig. 5 A illustrates the same initial delivery step, also shown in Fig. 4A. Subsequently, torque is applied to handle 212 (represented by arrow 290), while the fin remains pressed against the tissue (Fig. 5B). The torque applied to handle 212 is delivered to fin 214 via shaft 220. Arrow 292 represents fin 214 rotating (e.g., sliding rotationally over the surface of the tissue).

[0228] Fig. 5B represents the tissue not resisting (or unsubstantially resisting) rotational sliding of fin 214, that fin 214 therefor rotating relative to the tissue. Thus, there is no change in the relative positions of components within handle 212, and visual indicator 250 maintains the red portion visible via window 266 - and a determination is made that the tissue site is a non-anchoring location. Therefore, and as shown in Fig. 5C, fin 214 is removed from tissue site 231, without having driven a tissue anchor into tissue at tissue site 231.

[0229] In some implementations, and as represented in Fig. 5D, catheter 240 and fin 214 can then be placed at another tissue site within the heart, for evaluation of the quality of tissue at the other tissue site. In some implementations, and as shown, fin 214 and catheter 240 are moved to the other tissue site together (e.g., with no relative axial movement between them).

[0230] Reference is again made to Figs. Figs. 2A-C and 4A-5D. These figures illustrate methods that, in accordance with some implementations, include one, some, or all of the following: (i) transluminally advancing a distal end of a catheter into the heart; (ii) facing the distal end of the catheter to tissue at a first site in the heart; (iii) to the tissue at the firstsite, contacting a probe protruding from the distal end of the catheter; (iv) using the probe, applying a mechanical force to the tissue at the first site; (v) using an extracorporeal measurement device operatively coupled to the probe, obtaining a value indicative of resistance of the tissue to the mechanical force; (vi) determining whether the value is indicative of greater-than-threshold resistance; and / or (vii) responsively, to the step of determining, designating the first site as an anchoring site or a non-anchoring site. In some implementations, this designating comprises: (a) if the value is indicative of greater-than- threshold resistance, while the distal end of the catheter remains facing the tissue at the first site, driving a tissue-engaging element of an anchor out of the distal end of the catheter and into the tissue at the first site; whereas (b) if the value is not indicative of greater-than- threshold resistance, moving the distal end of the catheter to face tissue at another site in the heart without driving the tissue-engaging element of the anchor out of the distal end of the catheter and into the tissue at the first site.

[0231] Similarly, Figs. 2A-C and 4A-5D illustrate methods that, in accordance with some implementations, include one, some, or all of the following: (i) transluminally advancing a distal end of a catheter into the heart; (ii) facing the distal end of the catheter to tissue at a site in the heart; (iii) to the tissue at the site, contacting a probe protruding from the distal end of the catheter; (iv) using the probe, applying a mechanical force to the tissue at the site; (v) using an extracorporeal measurement device operatively coupled to the probe, measuring a resistance of the tissue to the mechanical force; and (vi) responsively to determining that the measured resistance is greater than a threshold resistance, while the distal end of the catheter remains facing the tissue at the site: (a) withdrawing the probe from the catheter, (b) advancing an anchor through the catheter, and (c) driving a tissue-engaging element of the anchor out of the distal end of the catheter and into the tissue at the site.

[0232] For these methods, system / apparatus is therefore provided that comprises: (i) a catheter configured to be transluminally advanced into the heart, the catheter having a proximal part and a steerable distal part, and a catheter axis therebetween; (ii) a tissue-testing assembly including (a) a probe, adapted to be advanced out of a distal end of the catheter and to engage tissue at a tissue site of the heart; and (b) a measurement device, operatively coupled to the probe, and configured to obtain from the probe a value indicative of a characteristic of the tissue at the tissue site; and (iii) an anchor driver, advanceable through the catheter independently of the probe, and configured to drive a tissue anchor (e.g., ananchor selected to be suitable for the tissue based on the characteristic of the tissue, etc.) into the tissue site.

[0233] Reference is again made to Figs. 1A-5D. Although the systems and techniques disclosed herein have been described primarily in the context of a heart valve (e.g., the tissue being tested is shown as tissue of the annulus of the heart valve), it is to be understood that the scope of the present disclosure includes utilizing these systems and techniques at other locations within the cardiovascular system (e.g., at other locations within the heart) such as an atrial wall tissue, a ventricular wall, a papillary muscle, an interventricular septum, an interatrial septum, and a blood vessel wall.

[0234] Example Implementations (some non-limiting examples of the concepts herein are recited below):

[0235] Example 1. A system for use with a heart of a subject, the system comprising (a) a catheter having a distal opening that is configured to be transluminally advanced toward a tissue of the heart, the catheter defining a catheter axis between the distal opening and a proximal part of the catheter; and / or (b) a tissue-testing tool having: (i) an extracorporeal part that comprises a handle and a force meter, (ii) an intracorporeal part that comprises a probe, and / or (iii) a shaft, linking the extracorporeal part to the intracorporeal part in a manner that facilitates advancement of the probe through the catheter, out of the distal opening, and into contact with the tissue, and / or transfer of a force from the handle to the probe while the probe is in contact with the tissue, wherein the tool is configured such that, while the probe is in contact with the tissue, the force meter provides an output indicative of a magnitude of a resistance, provided by the tissue, to movement of the probe responsive to the force applied to the handle.

[0236] Example 2. The system according to example 1, wherein the force is torque, the movement is rotation, and the tool is configured such that, while the probe is in contact with the tissue, the force meter provides an output indicative of a magnitude of a resistance, provided by the tissue, to the rotation of the probe responsive to the torque applied to the handle.

[0237] Example 3. The system according to example 1, wherein the force is pulling, the movement is retraction from the tissue, and the tool is configured such that, while the probe is in contact with the tissue, the force meter provides an output indicative of a magnitude ofa resistance, provided by the tissue, to the retraction of the probe from the tissue responsive to the pulling applied to the handle.

[0238] Example 4. The system according to any one of examples 1-3, wherein the probe is configured to be pressed against a surface of the tissue.

[0239] Example 5. The system according to example 4, wherein the probe is shaped to define a fin.

[0240] Example 6. The system according to any one of examples 1-3, wherein the probe is configured to be penetrated into the tissue.

[0241] Example 7. The system according to example 6, wherein the probe is shaped to define a needle.

[0242] Example s. The system according to any one of examples 1-7, wherein the catheter comprises, proximate to the distal opening, a retainer configured to reversibly engage the intracorporeal part of the tool in a manner that inhibits axial movement of the probe with respect to the catheter.

[0243] Example 9. The system according to example 8, wherein the retainer is configured to facilitate rotation of the probe with respect to the catheter while inhibiting axial movement of the probe with respect to the catheter.

[0244] Example 10. The system according to any one of examples 1-9, further comprising a tissue anchor, and an anchor driver that is advanceable through the catheter independently of the tool, and that is configured to drive the tissue anchor into the tissue.

[0245] Example 11. The system according to example 10, wherein the tool is removable from the catheter, and the anchor driver is configured to advance the anchor through the catheter upon removal of the tool from the catheter.

[0246] Example 12. A system for use with a heart of a subject, the system comprising (a) a catheter having a distal opening that is configured to be transluminally advanced toward a tissue of the heart, the catheter defining a catheter axis between the distal opening and a proximal part of the catheter; and / or (b) a tissue-testing tool having (i) an extracorporeal part that comprises a handle and a torque meter, (ii) an intracorporeal part that comprises a probe, and / or (iii) a shaft, linking the extracorporeal part to the intracorporeal part in a manner that facilitates advancement of the probe through the catheter and out of the distal opening, and / or transfer of torque from the handle to the probe while pressing the probe against asurface of the tissue, wherein the tool is configured such that, while the probe is pressed against the surface of the tissue, the torque meter provides an output indicative of a magnitude of a resistance, provided by the tissue, to rotation of the probe responsive to the torque applied to the handle.

[0247] Example 13. A system for use with a heart of a subject, the system comprising (a) a catheter configured to be transluminally advanced toward an anatomical site of the subject, the catheter having a proximal part and a steerable distal part, and a catheter axis therebetween; and / or (b) a tissue-testing assembly, comprising (i) an extracorporeal handle, comprising a torque meter, (ii) a probe, and / or (iii) a shaft, configured to transfer torque from the handle to the probe, the probe being disposed at a distal end of the shaft, and the handle being disposed at a proximal end of the shaft; wherein the shaft is adapted to be advanced through the catheter, to press the probe against a surface of a tissue at the anatomical site, and wherein the handle is configured such that, responsively to torque applied to the handle while the probe is pressed against the surface of the tissue, (i) the tissue-testing assembly rotates the probe against the surface of the tissue while the tissue provides resistance to the rotation of the probe, and (ii) the torque meter provides an output indicative of a magnitude of the resistance.

[0248] Example 14. The system according to example 13, wherein the probe comprises a protrusion, the shaft is configured to transfer torque from the handle to the protrusion, and to press the protrusion against the surface of the tissue at the anatomical site, and / or the handle is configured such that, responsively to torque applied to the handle while the protrusion is pressed against the surface of the tissue, (i) the tissue-testing assembly rotates the protrusion against the surface of the tissue while the tissue provides resistance to the rotation of the protrusion, and (ii) the torque meter provides an output indicative of a magnitude of the resistance.

[0249] Example 15. The system according to example 14, wherein the protrusion is shaped to define a fin.

[0250] Example 16. The system according to example 14, wherein the protrusion is shaped to define a paddle.

[0251] Example 17. The system according to example 14, wherein the protrusion is shaped to define a wave.

[0252] Example 18. The system according to example 14, wherein the protrusion is hexagonal.

[0253] Example 19. The system according to example 13, further comprising an anchor drive through which the shaft and the probe of the tissue-testing assembly are advanceable to the heart of the subject.

[0254] Example 20. The system according to example 19, wherein a distal end of the anchor drive includes a retention mechanism, adapted to engage the probe when the probe is advanced distally out of the anchor drive, so as to inhibit motion of the probe axially relative to the anchor drive during rotation of the probe.

[0255] Example 21. The system according to any one of examples 13-20, wherein the tissue-testing assembly further includes a visual indicator mechanically coupled to the probe, the visual indicator adapted to provide to a user a visual indication of the resistance of the tissue to rotation of the probe.

[0256] Example 22. The system according to any one of examples 13-21, wherein the probe is pressed against the surface of the tissue at a measurement location, the system further comprising at least one tissue anchor adapted to be advanced distally through the catheter, and to be anchored to the tissue at the measurement location when the resistance of the tissue at the measurement location to rotation of the probe is greater than a predetermined threshold.

[0257] Example 23. A method for use with a heart of a subject, the method comprising advancing into the heart of the subject a needle electrode, the needle electrode being in electrical communication with an impedance-measurement device; inserting the needle electrode into tissue at a first site in the heart; while the needle electrode remains disposed in the tissue at the first site, using the impedance-measurement device, obtaining an impedance value of the tissue at the first site; determining whether the obtained impedance value of the tissue at the first site lies within a predetermined impedance range; and / or in response to the determining, treating the first site as an anchoring location or a nonanchoring location, wherein treating comprises: if the obtained impedance value of the tissue at the first site lies within the predetermined impedance range, driving a tissue anchor into the tissue at the first site, and retracting the needle electrode from the tissue at the first site; whereas if the obtained impedance value of the tissue at the first site lies outside of thepredetermined impedance range, moving the needle electrode from the first site to a second site in the heart, without having driven the tissue anchor into the tissue at the first site.

[0258] Example 24. The method according to example 23, wherein advancing of the needle electrode comprises advancing a bipolar needle including a measurement electrode and a reference electrode.

[0259] Example 25. The method according to example 23, further comprising, prior to obtaining the impedance value, advancing a reference electrode to the tissue and placing the reference electrode on a surface of the tissue at the first site.

[0260] Example 26. The method according to any one of examples 23-25, wherein the advancing comprises transluminally advancing the needle electrode into the heart of the subject via a catheter.

[0261] Example 27. The method according to example 26, wherein driving the tissue anchor into the tissue at the first site includes transluminally advancing an anchor driver and the tissue anchor into the heart of the subject via the catheter.

[0262] Example 28. The method according to example 26, wherein driving the tissue anchor into the tissue at the first site includes transluminally advancing an anchor driver and the tissue anchor into the heart of the subject via a second catheter.

[0263] Example 29. The method according to any one of examples 26-28, wherein retracting the needle electrode from the tissue comprises retracting the needle electrode from the heart of the subject via the catheter.

[0264] Example 30. The method according to any one of examples 26-29, further comprising, maintaining the catheter at the first site during the retracting of the needle electrode from the tissue at the first site and the driving of the tissue anchor into the tissue at the first site.

[0265] Example 31. A system for use with a heart of a subject, the system comprising (a) a catheter configured to be transluminally advanced into the heart, the catheter having a proximal part and a steerable distal part, and a catheter axis therebetween; (b) an impedancemeasurement device including (i) a needle electrode, adapted to be advanced out of the catheter and inserted into a tissue site of the heart; (ii) a reference electrode; and / or(iii) an impedance-measurement device placeable in electrical communication with the needle electrode and with the reference electrode, and configured to measure an impedance valueof the tissue site; and / or (c) an anchor driver, advanceable through the catheter independently of the impedance-measurement device and configured to drive a tissue anchor into the tissue site.

[0266] Example 32. The system according to example 31, wherein the impedancemeasurement device comprises a bipolar needle housing the needle electrode and the reference electrode.

[0267] Example 33. The system according to example 31, wherein the reference electrode is separate from the needle electrode, and is adapted to be advanced into the heart of the subject distally out of the catheter and placed in contact with the tissue at the tissue site prior to measurement of the impedance value.

[0268] Example 34. The system according to any one of examples 31-33, wherein the needle electrode is adapted to be retracted from the tissue site of the heart prior to the anchor driver driving the tissue anchor into the tissue site.

[0269] Example 35. The system according to any one of examples 31-34, wherein the catheter is adapted to maintain its location at the tissue site during retraction of the needle electrode from the tissue site and driving of the tissue anchor into the tissue site.

[0270] Example 36. The system according to any one of examples 31-35, wherein the anchor driver is configured to drive the tissue anchor into the tissue site only when the impedance value measured by the impedance-measurement device at the tissue site is within a predetermined impedance range.

[0271] Example 37. A method for use with a heart of a subject, the method comprising: transluminally advancing into the heart of the subject a needle, the needle being coupled to a measurement device; inserting the needle into tissue at a first site in the heart; using the measurement device, obtaining a value indicative of a characteristic of the tissue at the first site; determining whether the obtained value lies within a predetermined range; and / or in response to the determining, treating the first site as an anchoring location or a nonanchoring location, wherein treating comprises: if the obtained value lies within the predetermined range, driving a tissue anchor into the tissue at the first site, and retracting the needle from the tissue at the first site; whereas if the obtained value lies outside of the predetermined range, moving the needle from the first site to a second site in the heart, without having driven the tissue anchor into the tissue at the first site.

[0272] Example 38. The method according to example 37, wherein the needle comprises a needle electrode, the advancing comprises transluminally advancing the needle electrode, and the inserting comprises inserting the needle electrode; and / or the measurement device comprises an impedance-measurement device, the obtaining the value comprises obtaining an impedance value of the tissue at the first site, and the determining comprises determining whether the impedance value lies within a predetermined impedance range.

[0273] Example 39. The method according to example 38, wherein advancing of the needle comprises advancing a bipolar needle including a measurement electrode and a reference electrode.

[0274] Example 40. The method according to example 38, further comprising, prior to obtaining the value, advancing a reference electrode to the tissue and placing the reference electrode on a surface of the tissue at the first site.

[0275] Example 41. The method according to example 37, wherein the needle comprises a probe needle, the transluminally advancing comprises transluminally advancing the probe needle, and the inserting comprises inserting the probe needle; and / or the measurement device comprises a force-measurement device, the obtaining the value comprises obtaining a force threshold (e.g., force required) for removing the probe needle from the tissue at the first site, and the determining comprises determining whether the force lies within a predetermined force range.

[0276] Example 42. The method according to any one of examples 37-41, wherein the advancing comprises transluminally advancing the needle into the heart of the subject via a catheter.

[0277] Example 43. The method according to example 42, wherein driving the tissue anchor into the tissue at the first site includes transluminally advancing an anchor driver and the tissue anchor into the heart of the subject via the catheter.

[0278] Example 44. The method according to example 42, wherein driving the tissue anchor into the tissue at the first site includes transluminally advancing an anchor driver and the tissue anchor into the heart of the subject via a second catheter.

[0279] Example 45. The method according to any one of examples 42-44, wherein retracting the needle from the tissue comprises retracting the needle from the heart of the subject via the catheter.

[0280] Example 46. The method according to any one of examples 42-45, further comprising, maintaining the catheter at the first site during the retracting of the needle from the tissue at the first site and the driving of the tissue anchor into the tissue at the first site.

[0281] Example 47. A system for use with a heart of a subject, the system comprising (a) a catheter configured to be transluminally advanced into the heart, the catheter having a proximal part and a steerable distal part, and a catheter axis therebetween; (b) a measurement assembly including a needle, adapted to be advanced out of the catheter and inserted into a tissue site of the heart; and / or a measurement device configured to obtain a value indicative of a characteristic of the tissue at the tissue site; and / or (c) an anchor driver, advanceable through the catheter independently of the measurement assembly, and configured to drive a tissue anchor into the tissue site.

[0282] Example 48. The system according to example 47, wherein the needle comprises a needle electrode, the measurement device comprises an impedance-measurement device configured to obtain an impedance value of the tissue at the tissue site, and the measurement assembly further comprises a reference electrode.

[0283] Example 49. The system according to example 48, wherein the measurement assembly comprises a bipolar needle housing the needle electrode and the reference electrode.

[0284] Example 50. The system according to example 48, wherein the reference electrode is separate from the needle electrode and is adapted to be advanced into the heart of the subject distally out of the catheter and placed in contact with the tissue at the tissue site prior to measurement of the impedance value.

[0285] Example 51. The system according to example 47, wherein the needle comprises a probe needle, and the measurement device comprises a force-measurement device configured to obtain a force threshold for removing the probe needle from the tissue at the tissue site.

[0286] Example 52. The system according to example 51, wherein the probe needle comprises a barbed needle.

[0287] Example 53. The system according to example 51, wherein the probe needle comprises a screw probe adapted to be rotationally inserted into the tissue.

[0288] Example 54. The system according to any one of examples 47-53, wherein the needle is adapted to be retracted from the tissue site of the heart prior to the anchor driver driving the tissue anchor into the tissue site.

[0289] Example 55. The system according to any one of examples 47-54, wherein the catheter is adapted to maintain its location at the tissue site during retraction of the needle from the tissue site and driving of the tissue anchor into the tissue site.

[0290] Example 56. The system according to any one of examples 47-55, wherein the anchor driver is configured to drive the tissue anchor into the tissue site only when the value obtained by the measurement device at the tissue site is within a predetermined range.

[0291] Example 57. A method for use with a heart of a subject, the method comprising advancing into the heart of the subject a probe needle, the probe needle being coupled to a force-measurement device; inserting the probe needle into tissue at a first site in the heart; using the force-measurement device, obtaining a value of force threshold to remove the probe needle from the tissue at the first site; determining whether the obtained value of the force lies within a predetermined force range; and / or in response to the determining, treating the first site as an anchoring location or a non-anchoring location, wherein treating comprises: if the obtained value of the force lies within the predetermined force range, driving a tissue anchor into the tissue at the first site, and retracting the probe needle from the tissue at the first site; whereas if the obtained value of the force lies outside of the predetermined force range, moving the probe needle from the first site to a second site in the heart, without having driven the tissue anchor into the tissue at the first site.

[0292] Example 58. The method according to example 57, wherein the advancing of the probe needle comprises advancing a barbed needle.

[0293] Example 59. The method according to example 57, wherein the advancing of the probe needle comprises advancing a screw probe, and the inserting comprises rotationally inserting the screw probe into the tissue.

[0294] Example 60. The method according to any one of examples 57-59, wherein the advancing comprises transluminally advancing the probe needle into the heart of the subject via a catheter.

[0295] Example 61. The method according to example 60, wherein driving the tissue anchor into the tissue at the first site includes transluminally advancing an anchor driver and the tissue anchor into the heart of the subject via the catheter.

[0296] Example 62. The method according to example 60, wherein driving the tissue anchor into the tissue at the first site includes transluminally advancing an anchor driver and the tissue anchor into the heart of the subject via a second catheter.

[0297] Example 63. The method according to any one of examples 60-62, wherein retracting the probe needle from the tissue comprises retracting the probe needle from the heart of the subject via the catheter.

[0298] Example 64. The method according to any one of examples 60-63, further comprising, maintaining the catheter at the first site during the retracting of the probe needle from the tissue at the first site and the driving of the tissue anchor into the tissue at the first site.

[0299] Example 65. A system for use with a heart of a subject, the system comprising: (a) a catheter configured to be transluminally advanced into the heart, the catheter having a proximal part and a steerable distal part, and a catheter axis therebetween; (b) a forcemeasurement assembly including a probe needle, adapted to be advanced out of the catheter and inserted into a tissue site of the heart; and / or a force-measurement device coupled to the probe needle, and configured to measure a force threshold to remove the probe needle from the tissue at the tissue site; and / or (c) an anchor driver, advanceable through the catheter independently of the force-measurement assembly and configured to drive a tissue anchor into the tissue site.

[0300] Example 66. The system according to example 65, wherein the probe needle comprises a barb anchor.

[0301] Example 67. The system according to example 65, wherein the probe needle comprises a screw probe adapted to be rotationally inserted into the tissue.

[0302] Example 68. The system according to any one of examples 65-67, wherein the probe needle is adapted to be retracted from the tissue site of the heart prior to the anchor driver driving the tissue anchor into the tissue site.

[0303] Example 69. The system according to any one of examples 65-68, wherein the catheter is adapted to maintain its location at the tissue site during retraction of the probe needle from the tissue site and driving of the tissue anchor into the tissue site.

[0304] Example 70. The system according to any one of examples 65-69, wherein the anchor driver is configured to drive the tissue anchor into the tissue site only when the forcemeasured by the force-measurement device at the tissue site is within a predetermined force range.

[0305] Example 71. A method for use with a heart of a subject, the method comprising transluminally advancing into the heart of the subject a probe disposed at a distal end of a shaft, a proximal end of the shaft being connected to an extracorporeal handle including a torque meter, the shaft being adapted to transfer torque from the handle to the probe; pressing the probe against a surface of a tissue at a tissue site in the heart; applying torque to the handle while the probe is pressed against the surface of the tissue at the tissue site, so as to rotate the probe against the surface of the tissue while the tissue provides resistance to the rotation of the probe; and / or responsive to the application of torque, receiving an output from the torque meter, the output indicative of a magnitude of the resistance of the tissue to the rotation of the probe.

[0306] Example 72. The method according to example 71, wherein the probe includes a protrusion, pressing the probe against the surface of the tissue at the tissue site comprises pressing the protrusion against the surface of the tissue at the tissue site, and / or applying torque to the handle while the probe is pressed against the surface of the tissue at the tissue site comprises applying torque to the handle while the protrusion is pressed against the surface of the tissue at the tissue site, so as to rotate the protrusion against the surface of the tissue while the tissue provides resistance to the rotation of the protrusion.

[0307] Example 73. The method according to example 71, wherein receiving the output from the torque meter comprises receiving the output from a mechanical torque meter.

[0308] Example 74. The method according to example 71, wherein receiving the output from the torque meter comprises receiving the output from an electronic torque meter.

[0309] Example 75. The method according to any one of examples 71-74, wherein receiving the output comprises receiving a visual output including an indication of high resistance, moderate resistance, or low resistance of the tissue to rotation of the probe.

[0310] Example 76. The method according to any one of examples 71-75, wherein the advancing comprises transluminally advancing the probe into the heart of the subject via a catheter.

[0311] Example 77. The method according to any one of examples 71-76, wherein the advancing comprises transluminally advancing the probe into the heart of the subject via an anchor driver.

[0312] Example 78. The method according to any one of examples 76-77, further comprising, in response to receiving the output, treating the tissue site as an anchoring location or a non-anchoring location, wherein treating comprises: if the output is indicative of the resistance of the tissue at the tissue site to rotation of the probe being greater than a predetermined resistance threshold, driving a tissue anchor into the tissue at the tissue site, and retracting the probe from the tissue at the tissue site; whereas if the output is indicative of the resistance of the tissue at the tissue site to rotation of the probe not being greater than the predetermined resistance threshold, moving the probe from the tissue site to a second tissue site in the heart, without having driven the tissue anchor into the tissue at the tissue site.

[0313] Example 79. The method according to example 78, wherein driving the tissue anchor into the tissue at the tissue site includes transluminally advancing an anchor driver and the tissue anchor into the heart of the subject via the catheter.

[0314] Example 80. The method according to any one of examples 78-79, wherein retracting the probe from the tissue comprises retracting the probe from the heart of the subject via the catheter.

[0315] Example 81. A method for use with a heart of a subject, the method comprising: transluminally advancing into the heart of the subject a probe, the probe being coupled to an extracorporeal measurement device; coupling the probe to tissue at a first site in the heart; using the measurement device, obtaining a value indicative of a characteristic of the tissue at the first site; determining whether the obtained value lies within a predetermined range; and / or, responsively to the determining, treating the first site as an anchoring location or a non-anchoring location, wherein treating comprises: if the obtained value lies within the predetermined range, driving a tissue anchor into the tissue at the first site, and retracting the probe from the tissue at the first site; whereas if the obtained value lies outside of the predetermined range, moving the probe from the first site to a second site in the heart, without having driven the tissue anchor into the tissue at the first site.

[0316] Example 82. A system for use with a heart of a subject, the system comprising (a) a catheter configured to be transluminally advanced into the heart, the catheter having a proximal part and a steerable distal part, and a catheter axis therebetween; (b) a tissue-testing assembly including a probe, adapted to be advanced out of a distal end of the catheter and to engage tissue at a tissue site of the heart; and / or a measurement device, operatively coupledto the probe, and configured to obtain from the probe a value indicative of a characteristic of the tissue at the tissue site; and / or (c) an anchor driver, advanceable through the catheter independently of the probe, and configured to drive a tissue anchor into the tissue site.

[0317] Example 83. The system according to example 82, wherein the characteristic is an electrical characteristic of the tissue, and / or the measurement device is configured to obtain, from the probe, a value indicative of the electrical characteristic of the tissue.

[0318] Example 84. The system according to example 82, wherein the characteristic is a mechanical characteristic of the tissue, and / or the measurement device is configured to obtain, from the probe, a value indicative of the mechanical characteristic of the tissue.

[0319] Example 85. The system according to example 82, wherein the probe comprises a needle, configured to engage the tissue by penetrating the tissue.

[0320] Example 86. The system according to example 85, wherein the needle comprises an electrode, the characteristic is impedance, and / or the measurement device is configured to output a value indicative of the impedance.

[0321] Example 87. The system according to example 85, wherein the needle is shaped to define one or more grips, the characteristic is a magnitude of mechanical resistance to retraction from the tissue, and / or the measurement device is configured to output a value indicative of the magnitude of resistance to retraction from the tissue.

[0322] Example 88. The system according to example 88, wherein the probe comprises a fin, configured to engage the tissue by pressing against the surface of the tissue.

[0323] Example 89. The system according to example 88, wherein the tissue-testing assembly is configured to apply torque to the fin while the fin is pressed against the surface of the tissue, the characteristic is a magnitude of mechanical resistance of the tissue to rotation of the fin, and / or the measurement device is configured to output a value indicative of the magnitude of resistance of the tissue to rotation of the fin.

[0324] Example 90. A method for use with a heart of a subject, the method comprising: transluminally advancing a distal end of a catheter into the heart; facing the distal end of the catheter to tissue at a first site in the heart; to the tissue at the first site, contacting a probe protruding from the distal end of the catheter; using the probe, applying a mechanical force to the tissue at the first site; using an extracorporeal measurement device operatively coupled to the probe, obtaining a value indicative of resistance of the tissue to the mechanical force;determining whether the value is indicative of greater-than-threshold resistance; and / or responsively, to the step of determining, designating the first site as an anchoring site or a non-anchoring site, wherein designating comprises: if the value is indicative of greater-than- threshold resistance, while the distal end of the catheter remains facing the tissue at the first site, driving a tissue-engaging element of an anchor out of the distal end of the catheter and into the tissue at the first site; whereas if the value is not indicative of greater-than-threshold resistance, moving the distal end of the catheter to face tissue at another site in the heart without driving the tissue-engaging element of the anchor out of the distal end of the catheter and into the tissue at the first site.

[0325] Example 91. The method according to example 90, wherein contacting the probe to the tissue at the first site comprises inserting a needle into the tissue at the first site.

[0326] Example 92. The method according to example 90, wherein contacting the probe to the tissue at the first site comprises pressing a fin against a surface of the tissue at the first site.

[0327] Example 93. The method according to example 90, wherein the mechanical force is torque, and the value obtained is indicative of resistance of the tissue to the torque.

[0328] Example 94. The method according to example 90, wherein the mechanical force is a pulling force, and the value obtained is indicative of resistance of the tissue to the pulling force.

[0329] Example 95. A method for use with a heart of a subject, the method comprising: transluminally advancing a distal end of a catheter into the heart; facing the distal end of the catheter to tissue at a site in the heart; to the tissue at the site, contacting a probe protruding from the distal end of the catheter; using the probe, applying a mechanical force to the tissue at the site; using an extracorporeal measurement device operatively coupled to the probe, measuring a resistance of the tissue to the mechanical force; and / or responsively to determining that the measured resistance is greater than a threshold resistance, while the distal end of the catheter remains facing the tissue at the site: (i) withdrawing the probe from the catheter, (ii) advancing an anchor through the catheter, and / or (iii) driving a tissueengaging element of the anchor out of the distal end of the catheter and into the tissue at the site.

[0330] Example 96. The method according to example 95, wherein contacting the probe to the tissue at the site comprises inserting a needle into the tissue at the site.

[0331] Example 97. The method according to example 95, wherein contacting the probe to the tissue at the site comprises pressing a fin against a surface of the tissue at the site.

[0332] Example 98. The method according to example 95, wherein the mechanical force is torque, and measuring the resistance comprises measuring the resistance of the tissue to the torque.

[0333] Example 99. The method according to example 95, wherein the mechanical force is a pulling force, and measuring the resistance comprises measuring the resistance of the tissue to the pulling force.

[0334] Example 100. A system comprising a measurement assembly comprising (a) a probe adapted to be advanced into contact with a tissue site inside of a subject; and / or (b) a measurement device configured to obtain, via the contact between the probe and the tissue site, a value indicative of a characteristic of the tissue at the tissue site.

[0335] Example 101. The system of example 84, further comprising a catheter configured to be transluminally advanced into a subject, wherein the probe can be advanced out of the catheter and into contact with the tissue site.

[0336] Example 102. The system of any one of examples 84-85, further comprising an anchor driver, advanceable independently of the measurement assembly, and configured to drive a tissue anchor into the tissue site.

[0337] Example 103. The system according to any one of examples 100-102, wherein the probe comprises a needle electrode.

[0338] Example 104. The system according to any one of examples 100-103, wherein the measurement device comprises an impedance-measurement device configured to obtain an impedance value of the tissue at the tissue site.

[0339] Example 105. The system according to any one of examples 100-104, wherein the measurement assembly further comprises a reference electrode.

[0340] Example 106. The system according to example 105, wherein the measurement assembly comprises a bipolar needle housing a needle electrode and the reference electrode.

[0341] Example 107. The system according to example 105, further comprising a needle electrode, wherein the reference electrode is separate from the needle electrode, and the reference electrode is adapted to be advanced into the heart of the subject distally out of thecatheter and placed in contact with the tissue at the tissue site prior to measurement of the value indicative of the characteristic of the tissue at the tissue site.

[0342] Example 108. The system according to any one of examples 100-107, wherein the probe comprises a probe needle, and the measurement device comprises a forcemeasurement device configured to obtain a force threshold for inserting the probe needle into the tissue at the tissue site and / or a force threshold for removing the probe needle from the tissue at the tissue site.

[0343] Example 109. The system according to example 108, wherein the probe needle comprises a barbed needle.

[0344] Example 110. The system according to example 108, wherein the probe needle comprises a screw probe adapted to be rotationally inserted into the tissue.

[0345] Example 111. The system according to any one of examples 100-110, wherein the probe is adapted to be retracted from the tissue site prior to an anchor driver driving a tissue anchor into the tissue site.

[0346] Example 112. The system according to example 111, wherein a catheter is adapted to maintain its location at the tissue site during retraction of the probe from the tissue site and driving of the tissue anchor into the tissue site.

[0347] Example 113. The system according to any one of examples 100-112, wherein an anchor driver is configured to drive a tissue anchor into the tissue site only when the value obtained by the measurement device at the tissue site is within a predetermined range.

[0348] Example 114. The system according to any one of examples 100-113, further comprising a handle, wherein the handle is configured such that, responsively to torque applied to the handle while the probe is pressed against the tissue at the tissue site, (i) the tissue-testing assembly rotates the probe against a surface of the tissue while the tissue provides resistance to the rotation of the probe, and (ii) a torque meter provides an output indicative of a magnitude of the resistance.

[0349] Example 115. The system according to any one of examples 100-114, wherein the probe comprises a protrusion.

[0350] Example 116. The system according to example 115, wherein the protrusion comprises a fin or paddle.

[0351] Example 117. The system according to any one of the preceding examples of systems, wherein the tool, the anchor driver, or the catheter is sterilized.

[0352] Example 118. The method according to any one of the preceding examples of methods, further comprising sterilizing the tool, the anchor driver, or the catheter.

[0353] The present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.

[0354] The techniques, methods, processes, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on a living subject (e.g., human, other animal, etc.) or on a simulation (e.g., a cadaver, cadaver heart, simulator, imaginary person, etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and / or physical representations of body parts, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc.

[0355] Any of the various systems, assemblies, devices, components, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of the associated system, device, component, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0356] Although the operations of some of the disclosed implementations are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth above. For example, operations or steps described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the descriptionsometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms can vary depending on the particular implementation and are discernible by one of ordinary skill in the art.

Claims

CLAIMSWhat is claimed is:

1. A system for use with a heart of a subject, the system comprising: a catheter having a distal opening that is configured to be transluminally advanced toward a tissue of the heart, the catheter defining a catheter axis between the distal opening and a proximal part of the catheter; and a tissue-testing tool having: an extracorporeal part that comprises a handle and a force meter, an intracorporeal part that comprises a probe, and a shaft, linking the extracorporeal part to the intracorporeal part in a manner that facilitates: advancement of the probe through the catheter, out of the distal opening, and into contact with the tissue, and transfer of a force from the handle to the probe while the probe is in contact with the tissue, wherein the tool is configured such that, while the probe is in contact with the tissue, the force meter provides an output indicative of a magnitude of a resistance, provided by the tissue, to movement of the probe responsive to the force applied to the handle.

2. The system according to claim 1, wherein the force is torque, the movement is rotation, and the tool is configured such that, while the probe is in contact with the tissue, the force meter provides an output indicative of a magnitude of a resistance, provided by the tissue, to the rotation of the probe responsive to the torque applied to the handle.

3. The system according to claim 1, wherein the force is pulling, the movement is retraction from the tissue, and the tool is configured such that, while the probe is in contact with the tissue, the force meter provides an output indicative of a magnitude of a resistance, provided by the tissue, to the retraction of the probe from the tissue responsive to the pulling applied to the handle.

4. The system according to any one of claims 1-3, wherein the probe is configured to be pressed against a surface of the tissue.

5. The system according to claim 4, wherein the probe is shaped to define a fin.

6. The system according to any one of claims 1-3, wherein the probe is configured to be penetrated into the tissue.

7. The system according to claim 6, wherein the probe is shaped to define a needle.

8. The system according to any one of claims 1-7, wherein the catheter comprises, proximate to the distal opening, a retainer configured to reversibly engage the intracorporeal part of the tool in a manner that inhibits axial movement of the probe with respect to the catheter.

9. The system according to claim 8, wherein the retainer is configured to facilitate rotation of the probe with respect to the catheter while inhibiting axial movement of the probe with respect to the catheter.

10. The system according to any one of claims 1-9, further comprising a tissue anchor, and an anchor driver that is advanceable through the catheter independently of the tool, and that is configured to drive the tissue anchor into the tissue.

11. The system according to claim 10, wherein the tool is removable from the catheter, and the anchor driver is configured to advance the anchor through the catheter upon removal of the tool from the catheter.

12. A system for use with a heart of a subject, the system comprising: a catheter having a distal opening that is configured to be transluminally advanced toward a tissue of the heart, the catheter defining a catheter axis between the distal opening and a proximal part of the catheter; and a tissue-testing tool having: an extracorporeal part that comprises a handle and a torque meter, and an intracorporeal part that comprises a probe, and a shaft, linking the extracorporeal part to the intracorporeal part in a manner that facilitates: advancement of the probe through the catheter and out of the distal opening, and transfer of torque from the handle to the probe while pressing the probe against a surface of the tissue,wherein the tool is configured such that, while the probe is pressed against the surface of the tissue, the torque meter provides an output indicative of a magnitude of a resistance, provided by the tissue, to rotation of the probe responsive to the torque applied to the handle.

13. A system for use with a heart of a subject, the system comprising: a catheter configured to be transluminally advanced toward an anatomical site of the subject, the catheter having a proximal part and a steerable distal part, and a catheter axis therebetween; and a tissue-testing assembly, comprising: an extracorporeal handle, comprising a torque meter, a probe, and a shaft, configured to transfer torque from the handle to the probe, the probe being disposed at a distal end of the shaft, and the handle being disposed at a proximal end of the shaft; wherein the shaft is adapted to be advanced through the catheter, to press the probe against a surface of a tissue at the anatomical site, wherein the handle is configured such that, responsively to torque applied to the handle while the probe is pressed against the surface of the tissue, (i) the tissue-testing assembly rotates the probe against the surface of the tissue while the tissue provides resistance to the rotation of the probe, and (ii) the torque meter provides an output indicative of a magnitude of the resistance.

14. The system according to claim 13, wherein: the probe comprises a protrusion, the shaft is configured to transfer torque from the handle to the protrusion, and to press the protrusion against the surface of the tissue at the anatomical site, and the handle is configured such that, responsively to torque applied to the handle while the protrusion is pressed against the surface of the tissue, (i) the tissue-testing assembly rotates the protrusion against the surface of the tissue while the tissue provides resistance to the rotation of the protrusion, and (ii) the torque meter provides an output indicative of a magnitude of the resistance.

15. The system according to claim 14, wherein the protrusion is shaped to define a fin.

16. A system for use with a heart of a subject, the system comprising:a catheter configured to be transluminally advanced into the heart, the catheter having a proximal part and a steerable distal part, and a catheter axis therebetween; a measurement assembly including: a needle, adapted to be advanced out of the catheter and inserted into a tissue site of the heart; and a measurement device configured to obtain a value indicative of a characteristic of the tissue at the tissue site; and an anchor driver, advanceable through the catheter independently of the measurement assembly, and configured to drive a tissue anchor into the tissue site.

17. The system according to claim 16, wherein the needle comprises a needle electrode, the measurement device comprises an impedance-measurement device configured to obtain an impedance value of the tissue at the tissue site, and the measurement assembly further comprises a reference electrode.

18. The system according to claim 17, wherein the measurement assembly comprises a bipolar needle housing the needle electrode and the reference electrode.

19. The system according to claim 17, wherein the reference electrode is separate from the needle electrode and is adapted to be advanced into the heart of the subject distally out of the catheter and placed in contact with the tissue at the tissue site prior to measurement of the impedance value.

20. The system according to claim 16, wherein the needle comprises a probe needle, and the measurement device comprises a force-measurement device configured to obtain a force threshold for removing the probe needle from the tissue at the tissue site.

21. The system according to claim 20, wherein the probe needle comprises a barbed needle.

22. The system according to claim 20, wherein the probe needle comprises a screw probe adapted to be rotationally inserted into the tissue.

23. The system according to any one of claims 16-22, wherein the needle is adapted to be retracted from the tissue site of the heart prior to the anchor driver driving the tissue anchor into the tissue site.

24. The system according to any one of claims 16-23, wherein the catheter is adapted to maintain its location at the tissue site during retraction of the needle from the tissue site and driving of the tissue anchor into the tissue site.

25. The system according to any one of claims 16-24, wherein the anchor driver is configured to drive the tissue anchor into the tissue site only when the value obtained by the measurement device at the tissue site is within a predetermined range.

26. A system for use with a heart of a subject, the system comprising: a catheter configured to be transluminally advanced into the heart, the catheter having a proximal part and a steerable distal part, and a catheter axis therebetween; a tissue-testing assembly including: a probe, adapted to be advanced out of a distal end of the catheter and to engage tissue at a tissue site of the heart; and a measurement device, operatively coupled to the probe, and configured to obtain from the probe a value indicative of a characteristic of the tissue at the tissue site; and an anchor driver, advanceable through the catheter independently of the probe, and configured to drive a tissue anchor into the tissue site.

27. The system according to claim 26, wherein: the characteristic is an electrical characteristic of the tissue, and the measurement device is configured to obtain, from the probe, a value indicative of the electrical characteristic of the tissue.

28. The system according to claim 26, wherein: the characteristic is a mechanical characteristic of the tissue, and the measurement device is configured to obtain, from the probe, a value indicative of the mechanical characteristic of the tissue.

29. The system according to claim 26, wherein the probe comprises a needle, configured to engage the tissue by penetrating the tissue.

30. The system according to claim 29, wherein: the needle comprises an electrode, the characteristic is impedance, and the measurement device is configured to output a value indicative of the impedance.

31. The system according to claim 29, wherein: the needle is shaped to define one or more grips, the characteristic is a magnitude of mechanical resistance to retraction from the tissue, and the measurement device is configured to output a value indicative of the magnitude of resistance to retraction from the tissue.

32. The system according to claim 32, wherein the probe comprises a fin, configured to engage the tissue by pressing against the surface of the tissue.

33. The system according to claim 32, wherein: the tissue-testing assembly is configured to apply torque to the fin while the fin is pressed against the surface of the tissue, the characteristic is a magnitude of mechanical resistance of the tissue to rotation of the fin, and the measurement device is configured to output a value indicative of the magnitude of resistance of the tissue to rotation of the fin.

34. A system comprising: a measurement assembly comprising: a probe adapted to be advanced into contact with a tissue site inside of a subject; and a measurement device configured to obtain, via the contact between the probe and the tissue site, a value indicative of a characteristic of the tissue at the tissue site.

35. The system of claim 84, further comprising a catheter configured to be transluminally advanced into a subject, wherein the probe can be advanced out of the catheter and into contact with the tissue site.

36. The system of any one of claims 84-85, further comprising an anchor driver, advanceable independently of the measurement assembly, and configured to drive a tissue anchor into the tissue site.

37. The system according to any one of claims 34-36, wherein the probe comprises a needle electrode.

38. The system according to any one of claims 34-37, wherein the measurement device comprises an impedance-measurement device configured to obtain an impedance value of the tissue at the tissue site.

39. The system according to any one of claims 34-38, wherein the measurement assembly further comprises a reference electrode.

40. The system according to claim 39, wherein the measurement assembly comprises a bipolar needle housing a needle electrode and the reference electrode.

41. The system according to claim 39, further comprising a needle electrode, wherein the reference electrode is separate from the needle electrode, and the reference electrode is adapted to be advanced into the heart of the subject distally out of the catheter and placed in contact with the tissue at the tissue site prior to measurement of the value indicative of the characteristic of the tissue at the tissue site.

42. The system according to any one of claims 34-41, wherein the probe comprises a probe needle, and the measurement device comprises a force-measurement device configured to obtain a force threshold for inserting the probe needle into the tissue at the tissue site and / or a force threshold for removing the probe needle from the tissue at the tissue site.

43. The system according to claim 42, wherein the probe needle comprises a barbed needle.

44. The system according to claim 42, wherein the probe needle comprises a screw probe adapted to be rotationally inserted into the tissue.

45. The system according to any one of claims 34-44, wherein the probe is adapted to be retracted from the tissue site prior to an anchor driver driving a tissue anchor into the tissue site.

46. The system according to claim 45, wherein a catheter is adapted to maintain its location at the tissue site during retraction of the probe from the tissue site and driving of the tissue anchor into the tissue site.

47. The system according to any one of claims 34-46, wherein an anchor driver is configured to drive a tissue anchor into the tissue site only when the value obtained by the measurement device at the tissue site is within a predetermined range.

48. The system according to any one of claims 34-47, further comprising a handle, wherein the handle is configured such that, responsively to torque applied to the handle while the probe is pressed against the tissue at the tissue site, (i) the tissue-testing assembly rotates the probe against a surface of the tissue while the tissue provides resistance to the rotation of the probe, and (ii) a torque meter provides an output indicative of a magnitude of the resistance.

49. The system according to any one of claims 34-48, wherein the probe comprises a protrusion.

50. The system according to claim 49, wherein the protrusion comprises a fin or paddle.

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