Delivery system for implanting a blood pressure measurements device in patient heart

Abstract

An implant delivery system (23) includes: (a) a cable (33) configured to couple with an implant (24) for delivery to a target position and to decouple therefrom; (b) a hollow grasper (55) movable along the cable, having a first section (71) with a larger inner lateral dimension (LD) (73), a second section (72) with a smaller inner LD (74), and multiple arms (88) operable to grasp the implant when closed and release it when opened; and (c) a spreader (77) coupled to the cable, having an outer LD (63) smaller than that of the first section but larger than that of the second section, and movable between the two sections to position the grasper arms in a closed position when moved to the first section, and in an opened position when moved to the second section.

Description

[0001] DELIVERY SYSTEM FOR IMPLANTING A BLOOD PRESSURE MEASUREMENTS DEVICE IN PATIENT HEART CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application 63 / 754,605, filed February 6, 2025, whose disclosure is incorporated herein by reference.

[0002] FIELD OF THE INVENTION

[0003] The present invention relates generally to medical devices, and particularly to methods and systems for delivering and implanting a blood pressure measurements device in patient heart.

[0004] BACKGROUND OF THE INVENTION

[0005] Various techniques for delivering and implanting a blood pressure measurements device have been published.

[0006] SUMMARY OF THE INVENTION

[0007] An embodiment of the present invention that is described herein provides an implant delivery system including (a) a cable configured to be (i) coupled to the implant and moved for delivering the implant to an intended position, and (ii) decoupled from the implant at the intended position, (b) a grasper, which is hollow and configured to be moved along the cable, the grasper including (i) a first section having a first inner lateral dimension (LD), (ii) a second section having a second inner LD smaller than the first inner LD of the first section, and (iii) multiple arms that are configured to grasp the implant when in a closed position, and to release the implant when in an opened position while the implant is coupled to the cable, and (c) a spreader, which is coupled to the cable and has an outer LD that is smaller than the inner LD of the first section but larger than the inner LD of the second section, the spreader configured to be moved by the cable, relative to the grasper, between the first and second sections of the grasper, to place the arms of the grasper in the closed position when moved to the first section, and in the opened position when moved to the second section.

[0008] In some embodiments, the system includs a grasper tube, which is hollow and having a third inner LD larger than the outer LD of the spreader, the grasper tube is coupled to the grasper and configured to be moved, along the cable along first and second directions opposite to one another, for moving the grasper, and in response to moving the cable, relative to the grasper, along the second direction, the spreader is moved through the second section into the grasper tube and the grasper resumes the closed position but does not grasp the implant. In otherembodiments, the implant includes an anchor having first and second meshes arranged in (i) a collapsed position for insertion along the first direction into an organ of a patient, and (ii) an extended position for attaching the first and second meshes to first and second sides of a septum of the organ, respectively, and the system further includes a connector, which is hollow, coupled to the second mesh and configured to be moved along the cable, and in the closed position the grasper is configured to grasp the connector and retain the second mesh in the collapsed position. In yet other embodiments, after the grasper resumes the closed position without grasping the implant, the grasper is configured to move the connector along the first direction to open the second mesh to the extended position and to place the second mesh in contact with the second side of the septum.

[0009] In some embodiments, the system further includes a handle positioned out of the organ and configured to (i) move the cable and the grasper tube independently from one another along the first and second directions, and (ii) decouple the cable from the implant. In other embodiments, the handle is configured to (i) perform a rotational movement about an axis, and (ii) convert the rotational movement to a linear movement of at least one of the cable and the grasper. In yet other embodiments, the system further includes a screw assembly having first and second parts configured to couple and decouple between the cable and the implant, respectively, and the handle is configured to apply an additional rotational movement to unscrew the first part from the second part.

[0010] In some embodiments, the system further includes a biocompatible lubricant disposed between the first and second parts of the screw assembly. In other embodiments, after delivering the implant to the intended position, the handle is configured to: (i) open the first mesh to the extended position by extracting the implant out of a sheath and moving the cable along the second direction, and (ii) place the first mesh, in the extended position, in contact with the first side of the septum by further moving at least the cable along the second direction. In yet other embodiments, the handle is configured to slide the connector along the first direction over the screw assembly, and subsequently, to apply the grasper to move the connector along the first direction to open the second mesh and to place the second mesh in contact with the second side of the septum.

[0011] In some embodiments, the cable is configured to guide the connector to position the second mesh at the intended position on the second side of the septum. In other embodiments, the implant includes a blood pressure measurement device configured to measure blood pressure in an atrium of a heart.In some embodiments, the system includes a marker, which is disposed over and at least partially encircling the connector, the marker is positioned at a proximal end of the anchor, and configured to provide an indication of (i) a location of the connector relative to the grasper, and (ii) a degree of the opening of the second mesh. In other embodiments, the marker includes a radiopaque marker configured to be visible under X-ray imaging. In yet other embodiments, the system further includes a buffer disposed over and at least partially encircling the connector, the buffer is configured to prevent electrical coupling between the marker and the second mesh.

[0012] There is additionally provided, in accordance with an embodiment of the present invention, a method including inserting into an organ of a patient (a) a cable coupled to (i) a spreader and (ii) an implant including an anchor having first and second meshes in a collapsed position, and (b) a grasper grasping the implant and sliding along the cable, and moving the cable and the grasper along a first direction to an intended position of the implant in a septum of the organ. The first mesh is opened to an extended position and at least the cable is moved along a second direction opposite the first direction to place the first mesh in contact with a first side of the septum, the grasper is moved along the first direction relative to the spreader and the implant, while the implant is coupled to the cable for (i) placing the grasper in an opened position and releasing the implant from the grasper, (ii) placing the grasper in a closed position after releasing the implant, (iii) opening the second mesh to an extended position, and (iv) placing the second mesh in contact with a second side of the septum.

[0013] The present invention will be more fully understood from the following detailed description of the embodiments thereof, taken together with the drawings in which:

[0014] BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Fig. 1 is a schematic, pictorial illustration of a system for combined assessment of body fluid retention and Left-Atrial (LA) blood pressure (LAP), in accordance with an embodiment of the present invention;

[0016] Figs. 2-6 are schematic, pictorial illustrations of steps for delivering and implanting the device of the system of Fig. 1, in accordance with embodiments of the present invention; and Fig. 7 is a flow chart that schematically illustrates a method for delivering and implanting the device of the system of Fig. 1, in accordance with an embodiment of the present invention.DETAILED DESCRIPTION OF EMBODIMENTS

[0017] OVERVIEW

[0018] Left Atrial Pressure (LAP) measurements in an ambulatory setting is a novel treatment paradigm that enables an accurate and reliable management of treating chronic heart failure (CHF). Such treatment may be carried out using an implant and related techniques configured to measure LAP that are described, for example, in U.S. Patent Application Publications 2018 / 0110468, and 2018 / 0098772, and in PCT Patent Application PCT / IB2023 / 055882, which are assigned to the assignee of the present patent application and whose disclosures are incorporated herein by reference.

[0019] Embodiments of the present invention that are described herein below provide improved techniques for delivering, in a patient heart, an implant configured to measure the blood pressure in the Left Atrium (LA) of the heart, also referred to herein as a LAP measurements device. In the present example, the implant is implanted across an interatrial septum of the patient's heart. As such, the implant comprises an anchor having first and second (e.g., distal and proximal) meshes arranged, along an axis of the implant, in (i) a collapsed position for insertion and movement along a first direction toward and through the septum, and (ii) an extended position for anchoring the distal and proximal meshes to left and right sides of the septum, respectively, as will be described in detail in Figs. 1-6 below. In some embodiments, the meshes are made from a suitable shape-memory alloy, such as nitinol (an alloy of nickel and titanium) configured to obtain a predefined shape in the extended position as will be described in detail below.

[0020] In some embodiments, a system for delivering the implant comprises a cable configured to be coupled to the implant and moved along the first direction for delivering the implant to an intended position (e.g., the desired position in the interatrial septum). In an embodiment, when the implant is positioned at the intended position, the distal mesh of the anchor is extended (as will be described below). Moreover, the delivery system is configured to be moved along a second direction opposite the first direction to place the distal mesh in contact with the septum. This process is also referred to herein as back-tenting, which is carried out to increase the friction between the septum and the distal mesh. The back-tenting process is further described below in the overview of operational method and in Fig. 3B. In some embodiments, after delivering and implanting the implant, the cable is configured to be decoupled from the implant at the intended position and to be moved along the second direction, so as to extract the cable out of the patient's body. In the present example, the coupling and decoupling between the cable and the implant is carried out using a screw assembly described in detail in Figs. 2A and 2B below. The systemfurther comprises a connector, which is coupled to the implant. In the present example, the connector is shaped as a ring made from a biocompatible material such as polyether ether ketone (PEEK). The ring has a distal end coupled to the proximal (second) mesh, and a proximal end adapted to be grasped.

[0021] In some embodiments, the delivery system comprises a grasper, which is hollow and configured to be moved along the cable. The grasper comprises (i) a first (distal) section having a first inner lateral dimension (LD), (ii) a second (proximal) section having a second inner LD smaller than the first inner LD of the distal section. In case the grasper has a circular cross section, the first and second inner LDs may comprise first and second inner diameters, respectively. The grasper further comprises multiple arms configured to (a) grasp the implant (e.g., grasp the proximal end of the ring) when in a closed position, and (b) release the proximal end of the ring to release the implant when in an opened position while the implant is coupled to the cable. Moreover, after releasing the implant, the grasper is configured to resume the closed position and to move the proximal mesh of the implant in the first direction, so as to place the proximal mesh in the extended position and to place the proximal mesh in contact with the right side of the septum. It is noted that the cable is threaded through the ring and the grasper and is configured to serve as a guidewire for accurately positioning the anchor at both sides of the septum.

[0022] In some embodiments, the delivery system comprises a spreader, which is coupled to the cable and has an outer LD that is (i) smaller than the inner LD of the distal (first) section of the grasper, but (ii) larger than the inner LD of the proximal (second) section of the grasper. Moreover, the delivery system comprises a hollow grasper tube having an inner diameter larger than the outer LD of the spreader, and the grasper tube is configured to be threaded over the cable and to be coupled to the proximal end of the grasper. As such, the spreader is configured to be moved between the first and second sections of the grasper, to place the arms of the grasper in the closed position when moved to the first section, and in the opened position when moved to the second section. The flow of the implant delivery and anchoring is described herein. In some embodiments, a cardiologist applies the cable threaded through a sheath to insert the implant into the patient's body with the anchor meshes in a collapsed position and moves the implant along the first direction toward the desired position in the interatrial septum (the procedure includes septum puncturing which is not in the scope of the present invention).

[0023] In some embodiments, after positioning the implant through the septum, the cardiologist pulls the sheath along the second direction to expose the distal mesh of the implant out of the sheath, and thereby partially opens the distal mesh of the anchor based on the shape memoryproperties of the nitinol mesh. Moreover, the cardiologist pulls the cable in the second direction to open the distal mesh to the extended position. Subsequently, the cardiologists pulls the sheath and delivery system along the second direction, so as to place the distal mesh (located in the left atrium) in contact with left side of the septum, which is the wall of the left atrium. The cardiologist may use echo (or any other suitable imaging technique) to check that the distal mesh is attached to the wall of the left atrium.

[0024] In some embodiments, after confirming that the distal mesh is attached to the wall of the left atrium, the cardiologist pulls the sheath along the second direction to extract the proximal mesh of the implant out of the sheath, and thereby to expose the proximal mesh. Subsequently, the cardiologist moves the grasper tube and the grasper along the first direction relative to the spreader to open the grasper for releasing the ring which is connected to the proximal mesh of the anchor as described above. The elasticity of the second mesh (and of the septum, to some extent) results in the released ring riding on the cable and moving along the first direction to partially extend the proximal mesh (e.g., between about 70% and 85% of its diameter in the fully extended position).

[0025] In some embodiments, after releasing the ring, the cardiologist continues the movement of the grasper tube and the grasper along the first direction, so that the spreader passes through the grasper and being inserted into the grasper tube, and thereby the grasper is closed. The cardiologist continues the movement of the grasper tube and the grasper along the first direction to further open the proximal mesh of the anchor to the fully extended position, and to place the proximal mesh in contact with the right side of the septum. It is noted that in response to the movement of the grasper tube and grasper along the cable, the spreader could be threaded through the (i) ring, (ii) the distal section of the grasper, and (iii) the grasper tube. It is noted, however, that the proximal section of the grasper must be expanded in order to enable passage of the spreader therethrough. The expansion of the proximal section of the grasper results in expansion of the distal section of the grasper, and thereby, in releasing of the ring from the grasper. As described above, after passing through the proximal section of the grasper, the spreader is threaded though the grasper tube and the grasper arms are placed again in the closed position. When the grasper resumes the closed position, the cardiologist uses the grasper to move the ring along the first direction, so as to open the proximal mesh to the fully extended position and to place the proximal mesh in contact with the right side of the septum, which is the wall of the right atrium. It is noted that during the opening of the proximal mesh, the anchor is released from the grasper, but the cable is still coupled with the implant tube. As such, the cable is used to guide the grasper and grasper tube aligned with a longitudinal axis of the implant tube. Thisalignment allows the attachment of the anchor to the walls of the septum while tightly controlling the positioning of the (longitudinal axis of the) implant tube relative to the walls of the septum. Finally, the cardiologist rotates the cable to unscrew and decouple from the implant and pulls the cable along the second direction out of the patient's body.

[0026] SYSTEM DESCRIPTION

[0027] Fig. l is a schematic, pictorial illustration of a system 11 for combined assessment of body fluid retention and Left- Atrial (LA) blood pressure, in accordance with an embodiment of the present invention. System 11 comprises an implanted device, also referred to herein as an implant 24, which is implanted at a desired location in a heart 28 of a patient 30 and is used for measuring the ambient blood pressure in its vicinity. In an example embodiment, implant 24 is implanted across an interatrial septum 80 of heart 28, and is configured to measure the blood pressure in the Left Atrium (LA).

[0028] In some embodiments, system 11 comprises an external unit 32, which is configured to communicate with implant 24 and to provide electrical power to the implant’s circuitry. In the present example, external unit 32 is fitted on a belt that is worn by the patient. The belt also comprises an antenna coil 13 of the external unit that surrounds the patient’s thorax. In the present example the belt is worn diagonally over the neck and one shoulder of the patient. Alternatively, however, any other suitable configuration can be used.

[0029] Implant 24 typically does not comprise an internal power source. The internal circuitry of the implant is powered by energy that is provided by external unit 32 using inductive coupling. Typically, external unit 32 generates an Alternating Current (AC) magnetic field via antenna coil 13. This magnetic field induces an AC voltage across an antenna of the implant, and this voltage is then rectified and used for powering the implant circuitry. At the same time, implant 24 sends data (e.g., measurement results of ambient blood pressure) by modulating the load impedance of its antenna, modulation that is sensed by the external unit 32.

[0030] Reference is now made to an inset 21 showing the mechanical structure of implant 24. In this example embodiment, implant 24 comprises an elongated tube 34 (also referred to herein as an implant tube 34) that comprises the electronic circuitry of the implant. Tube 34 is inserted into the interatrial septum 80 having a wall 81 of the left atrium and a wall 82 of the right atrium, in the context of the present disclosure and in the claims, the terms side and wall are used interchangeably so that septum 80 has left and right sides corresponding to walls 81 and 82. A septum gripper also referred to herein as an anchor 40, comprising a collapsible and extensible mesh of a shape-memory alloy (SMA) such as nitinol (made from an alloy of nickel andtitanium), is used for fixating tube 34 to the septum 80. In the present example, anchor 40 comprises meshes 39 and 41 placed in contact with walls 81 and 82, respectively.

[0031] In some embodiments, implant 24 comprises an electronic device, such as an application-specific integrated circuit (ASIC) 89 disposed in tube 34 in close proximity to a pressure sensor 38 located within a pressure cup 37, and an antenna coil 36 located within tube 34. In some embodiments, ASIC 89 and pressure sensor 38 are electrically connected with one another so as to exchange signals between one another. Implant 24 is implanted such that pressure sensor 38 and ASIC 89 are positioned in the left atrium. ASIC 89 is configured to receive from pressure sensor 38, ambient pressure measurements indicative of the ambient pressure of the blood in the LA of heart 28, and to transmit, via antenna 36, signals to external unit 32, as described above. In the present example, pressure sensor 38 comprises a microelectromechanical (MEMS) device configured to measure the ambient pressure in the blood pool of the LA. In some embodiments, ASIC 89 has an integrated temperature sensor configured to produce a signal indicative of the temperature of ASIC 89. It is noted that the temperature affects the accuracy of the pressure measurements, so that ASIC 89 is configured to determine the ambient pressure based on (i) the temperature measurement received from the aforementioned integrated temperature sensor, and (ii) the ambient pressure measurements received from sensor 38.

[0032] Implants of this sort are addressed in greater detail in U.S. Patent Application Publication 2018 / 0110468, entitled “Heart Implant with Septum Gripper” and in U.S. Patent Application Publication 2018 / 0098772, entitled “Deploying and Fixating an Implant Across an Organ Wall,” which are assigned to the assignee of the present patent application and whose disclosures are incorporated herein by reference.

[0033] Further aspects of blood pressure measurement using such implants, and of interaction between implants and external units using magnetic-field inductive coupling, are addressed, for example, in U.S. Patent Application Publication 2015 / 0282720, entitled “Drift Compensation for Implanted Capacitance-Based Pressure,” in U.S. Patent 10,105,103, entitled “Remotely Powered Sensory Implant,” in U.S. Patent Application Publication 2019 / 0008401, entitled “Power-Efficient Pressure-Sensor Implant,” and in U.S. Patent 10,205,488, entitled “Low-Power High- Accuracy Clock Harvesting in Inductive Coupling Systems.” All these patents and patent applications are assigned to the assignee of the present patent application, and their disclosures are incorporated herein by reference.

[0034] In some embodiments, external unit 32 comprises a wireless communication device configured to transmit signals comprising raw data indicative of the blood pressuremeasurements. System 11 comprises a cloud gateway device 18 configured to exchange signals with the wireless communication device of external unit 32. In the present example, the signals are exchanged using Bluetooth (BT) or using any other suitable communication protocol and devices. Cloud gateway device 18 is configured to transmit the signals to a cloud computing system, referred to herein as a cloud 15, which is configured to analyze the signals, and to display analyzed data described in detail below.

[0035] Additionally, or alternatively, gateway device 18 is configured to transmit the signals to a computer 12 of system 11 used by healthcare provider (not shown). In other embodiments, cloud gateway device 18 may be integrated into computer 12 or in any other suitable device or computing system.

[0036] In the present example, the analyzed data is transmitted from cloud 15 to computer 12, and at least a portion of the analyzed data is transmitted to a patient self-management web-based application installed on a mobile device 17 (e.g., a smartphone) of patient 30. In some embodiments, mobile device 17 may be used for exchanging the signals with cloud 15, instead of or in addition to gateway device 18.

[0037] In some embodiments, in addition to external unit 32 and antenna coil 13 the belt is electrically connected to a power source (not shown), such as a rechargeable battery. The belt may be worn by patient 30 out of the hospital (e.g., at home) or at the hospital when patient 30 is hospitalized. It is noted that the (i) blood pressure measurements, and (ii) the communication between external unit 32 and implant 24, are carried out during one or more daily time intervals (e.g., each time interval has a duration between about one minute and one hour), and the battery is being charged by the electrical grid not during these time intervals in order to prevent noise from the electrical grid to interfere with the blood pressure measurements.

[0038] In some embodiments, computer 12 comprises a processor 22, in the context of the present disclosure and in the claims, the term “processor” refers to one or more of the following devices: (i) any suitable type of a central processing unit (CPU) such as but not limited to a general -purpose processor, (ii) a graphical processing unit (GPU), (iii) a tensor processing unit (TPU), (iv) a digital signal processor (DSP), and (v) any other suitable type of an applicationspecific integrated circuit (ASIC). At least one of, and typically all the above types of processing units may have suitable front end and interface circuits configured for interfacing and exchanging signals with (a) several modules and stations of system 11, and (b) entities external to system 11.Additionally, or alternatively, computer 12 comprises an interface 20, which is configured to exchange data between processor 22 and other entities of system 11 and / or external to system 11, such as cloud 15.

[0039] In some embodiments, processor 22 and the electronic circuitry of the implant may be programmed in software to carry out the functions that are used by system 11, and store data for the software in a memory (not shown). The software may be downloaded to processor 22 and to the electronic circuitry of the implant in electronic form, over a network, for example, or it may be provided on non-transitory tangible media, such as optical, magnetic, or electronic memory media.

[0040] In some embodiments, computer 12 comprises a display device, referred to herein as a display 14, which is configured to display to the healthcare provider (e.g., a cardiologist, not shown) an image 19, such as a graph and / or data of the analyzed blood pressure measurements received from (i) processor 22, and / or (ii) cloud 15.

[0041] Figs. 2-6 are schematic, pictorial illustrations of steps for delivering and implanting implant 24 of system 11 in heart 28, in accordance with embodiments of the present invention Reference is now made to Figs. 2A and 2B, which are schematic, pictorial illustrations of implant 24 and a delivery system 23, in accordance with an embodiment of the present invention. It is noted that in Fig. 2B anchor 40 of implant 24 is removed for presenting components of delivery system 23.

[0042] In some embodiments, anchor 40 of Fig. 2A comprises collapsible and extensible meshes 39 and 41, used for fixating tube 34 to septum 80 of heart 28. In the example of Fig. 2A, meshes 39 and 41 are in a collapsed position, and in the extended position (shown in Figs. 1, 5 and 6) mesh 39 is configured to be placed in contact with the left wall 81 of septum 80 (shown in Fig.

[0043] 1 above), and mesh 41 is configured to be placed in contact with the right wall 82 of septum 80 (shown in Fig. 1 above) of heart 28. In some embodiments, in the extended position the size (e.g., diameter) of meshes 39 and 41 along septum 80 may be different from one another, as shown in the example of Fig. 1 above. More specifically, in the example of Fig. 1, mesh 39 is disposed in the left atrium where the blood pressure is higher and therefore has a larger diameter than that of mesh 41. In alternative embodiments, the size of meshes 39 and 41 along septum 80 (in the extended position) may be approximately equal to one another, or the size of mesh 41 may be larger than that of mesh 39.

[0044] Reference is now made to Fig. 2B. In some embodiments, delivery system 23 comprises a cable 33 threaded through a grasper tube 52 and coupled to implant 24 using a screw assembly referred to herein as a screw 99. Delivery system 23 comprises a handle 90 used by thecardiologist and configured to move cable 33, grasper tube 52 and screw 99 by rotating knobs of handle 90 in clockwise direction 91 and in counterclockwise direction 92. As such, handle 90 is configured to (i) perform one or more rotational movements in directions 91 and / or 92 (e.g., about an axis 53 or any other axis), and (ii) convert the rotational movements to a linear movement of at least one of cable 33 and grasper tube 52 (and thereby grasper 55). Screw 99 comprises first and second parts configured to couple and decouple between cable 33 and implant 24, respectively, and handle 90 is configured to screw and unscrew the first and second parts using rotational movements carried out by the cardiologist. In the present example, grasper tube 52 is hollow and cable 33 has a round cross section and are coaxial to one another. Delivery system 23 further comprises (i) a connector, referred to herein as a ring 66 made from poly ether ether ketone (PEEK) or from any other suitable biocompatible material, ring 66 is coupled to mesh 41 and configured to be moved (e.g., slide) along cable 33, (ii) a hollow grasper 55 configured to grasp and move ring 66 along cable 33, as will be described in detail below, and (iii) a spreader 77 coupled to cable 33 and configured to open grasper 55, as will be described in Fig. 4 below. In the present example, ring 66 is coupled with mesh 41 of anchor 40 and serves as a hollow connector between mesh 41 and grasper 55.

[0045] In some embodiments, delivery system 23 is coupled to implant 24 by rotating cable 33 and screw 99, e.g., in clockwise direction, about axis 53 of cable 33. In other embodiments, delivery system 23 may be coupled to implant 24 using any other coupling technique that allows detaching cable 33 from implant 24 after delivering and implanting implant 24 in heart 28, as will be described in Fig. 6 below.

[0046] In some embodiments, implant 24 comprises tube 34 having sections 29 and 31 intended to be positioned in the left atrium and right atrium of heart 28, respectively. In the extended position meshes 39 and 41 are coupled with sections 29 and 31, respectively, so as to anchor implant 24 to the left and right atria of heart 28, respectively.

[0047] In some embodiments, screw 99 has an outer lateral dimension (LD) 61, in the context of the present disclosure and in the claims, the term LD is used to generalize a size of a component, such that in components having a circular shape the LD refers to the diameter. As such, in case the cross section of a component is other than circular, the term LD does not refer to a diameter. Cable 33 has an outer diameter 62, spreader 77 has an outer LD 63, and ring 66 has an inner diameter 64 larger than outer LD 63 of spreader 77. In such embodiments, cable 33 is threaded through and coaxial with ring 66, grasper 55 and grasper tube 52.

[0048] In some embodiments, grasper 55 has a section 71 having an inner diameter 73, and a section 72 having an inner diameter 74. In the present example, LD 63 of spreader 77 is largerthan inner diameter 74 and smaller than inner diameter 73. Moreover, grasper tube 52 has an inner diameter 65, which is larger than outer LD 63 of spreader 77. In such embodiments, when grasper tube 52 and grasper 55 are moved along axis 53 relative to cable 33, spreader 77 could be threaded through ring 66, section 71 and grasper tube 52. It is noted, however, that section 72 must be expanded in order to enable passage of spreader 77 therethrough, as will be shown in Fig. 4 below.

[0049] Reference is now made to Fig. 3 A. In some embodiments, after positioning sections 29 and 31 in the left and right atria of heart 28, respectively, the cardiologist (i) extracts implant 24 out of a sheath (not shown) to partially open mesh 39 of anchor 40 using the shape memory property of the nitinol of mesh 39, and (ii) pulls cable 33 proximally, i.e., in a direction 54, to fully open mesh 39 of anchor 40 to the extended position. Subsequently, the cardiologist pulls the sheath and handle 90 (shown in Fig. 2B above) in direction 54, so as to place mesh 39 in contact with wall 81 of the septum 80 at the left atrium of heart 28. It is noted that pulling delivery system 23 in direction 54 enables carefully back-tenting of mesh 39 and obtaining increased friction (by increasing the normal force) between mesh 39 and the left wall 81 of the septum 80 of heart 28. In some embodiments, the cardiologist may use ultrasound (or any other suitable imaging technique) to verify that the distal mesh 39 of anchor 40 is attached to the wall 81 of the left atrium (as shown and described in detail in Fig. 1 above). After verifying that mesh 39 is attached to wall 81, the cardiologist pulls the sheath along direction 54 to extract the proximal mesh 41 out of the sheath, and thereby to expose mesh 41.

[0050] Reference is now made to Fig. 3B showing delivery system 23 by removing the meshes 39 and 41 of anchor 40 for the sake of presentation. In some embodiments, in response to moving (e.g., pulling) cable 33 in direction 54, spreader 77 passes through ring 66 as described in Fig.

[0051] 2B above, and therefore spreader 77 is not shown.

[0052] In some embodiments, delivery system 23 comprises a radiopaque marker 93 (also referred to herein as a marker 93, for brevity), which is made of tantalum or from any other suitable radiopaque material and is designed to be visible under X-ray imaging or other suitable imaging modalities. It is noted that because many polymers and biological tissues are radiolucent (typically invisible or indistinct under X-rays), radiopaque markers enable the cardiologist to accurately locate, track, and position delivery system 23 and implant 24 within heart 28 of patient 30. In the present example, marker 93 is ring-shaped, disposed over and at least partially encircling ring 66, and is positioned at the proximal end of anchor 40, in close proximity to mesh 41.In some embodiments, during the delivery and implantation of implant 24 in heart 28, radiopaque marker 93 is configured to provide the cardiologist with an indication of the location of ring 66 relative to grasper 55, thereby indicating whether ring 66 has been released from grasper 55, as described in detail in Fig. 4 below. Additionally, tube 34 of implant 24 is typically visible under X-rays. In some embodiments, a distance 27 between radiopaque marker 93 and section 31 or tube 34 provides the cardiologist with an indication of the degree of opening of mesh 41, as shown in Fig. 6 below. In these embodiments, when mesh 41 is in the collapsed position (shown in Fig. 3 A above), distance 27 is greater than when mesh 41 is in an opened position (shown in Figs. 5 and 6 below).

[0053] In some embodiments, radiopaque marker 93 is designed to provide the cardiologist with an indication of the orientation of anchor 40 relative to tube 34 along axis 53. For example, concentric alignment of marker 93 and tube 34 indicates that implant 24 and anchor 40 are properly aligned along axis 53.

[0054] In some embodiments, delivery system 23 further comprises a buffer 43, which has a ring shape and is disposed over and at least partially encircles ring 66. Buffer 43 is configured to prevent electrical coupling between marker 93 and mesh 41 of anchor 40. Electrical coupling between marker 93 and mesh 41 may produce a Faraday cage, which can attenuate and disrupt communication between external unit 32 and implant 24. In the present example, buffer 43 comprises an electrically insulating material, such as high-density polyethylene (HDPE) or any other suitable biocompatible, electrically insulating material. In these embodiments, marker 93 is both opaque, to assist the cardiologist during the implantation procedure, and electrically decoupled from mesh 41 of anchor 40, thereby preventing the formation of a Faraday cage and enabling the required level of communication between external unit 32 and implant 24. In other embodiments, instead of or in addition to buffer 43, delivery system 23 may comprise (i) electrical isolating coatings applied to mesh 41 and / or to marker 93, or (ii) having marker 93 embedded within the PEEK material of ring 66, so as to prevent electrical coupling between marker 93 and (mesh 41 of) anchor 40.

[0055] Reference is now made to Fig. 4. In some embodiments, in response to the cardiologist moving grasper tube 52 and grasper 55 in a direction 58 relative to cable 33, spreader 77 is threaded through ring 66 and section 71 of grasper 55, as described in Fig. 2B above. It is noted that the embodiments described herein are applicable to any movement of cable 33 and grasper 55 relative to one another. In some embodiments, inner diameter 74 of section 72 is smaller than LD 63 of spreader 77, thus, arms 88 of grasper 55 are configured to spread and be spaced apart from one another when cable 33 and grasper 55 move relative to one another, and spreader 77passes through section 72. The passage of spreader 77 through section 72, spreads arms 88 in section 71 of grasper 55 and thereby, releases ring 66 from grasper 55. It is noted that grasper 55 is configured to grasp ring 66 when arms 88 are fitted over the outer diameter of ring 66 and typically arms 88 are also placed in contact with one another. As described above, in the opened position grasper 55 is configured to release ring 66 when arms 88 of grasper 55 are spaced apart from one another (by spreader 77) in section 71 as shown in an inset 56 of Fig. 4. Moreover, ring 66 is coupled with mesh 41 of anchor 40. As such, the elasticity and of mesh 41 is configured to move ring 66 in direction 58 along cable 33 in direction 58, and thereby, to partially extend mesh 41 (e.g., to between about 70% and 85% of its diameter in the fully extended position.

[0056] Reference is now made to Fig. 5. In some embodiments, in response to the cardiologist further moving grasper tube 52 and grasper 55 in direction 58, spreader 77 is threaded through section 72 (shown in Fig. 4 above) of grasper 55 and being inserted into grasper tube 52 (having inner diameter 65 larger than LD 63 of spreader 77, as shown and described in Fig. 2B above). As such, grasper 55 resumes the closed position, and arms 88 are placed again in contact with one another (as shown in Figs. 2B and 3B above). It is noted that when section 71 is not fitted over ring 66, outer diameter 73 is approximately equal to an outer diameter 75 of ring 66. Subsequently, in some embodiments, the cardiologist uses handle 90 (shown in Fig. 2B above) to further move grasper tube 52 and grasper 55 in direction 58, so as to push ring 66 in direction 58, and thereby, to open mesh 41 of anchor 40 to be in the fully extended position. In the present example, section 31 of implant 24 is configured to stop the movement of ring 66 in direction 58, as shown in an inset 59. It is noted that the positioning of mesh 41 in the extended position also places mesh 41 in contact with the wall 82 of the septum 80 at the right atrium of heart 28. As such, meshes 39 and 41 of anchor 40 are attached to both sides (i.e., walls 81 and 82) of the septum 80 and prevent (or at least substantially reduce the) movement of implant 24. In other words, in the extended position, anchor 40 is configured to fixate tube 34 to the interatrial septum 80 of heart 28. It is noted that during the opening of mesh 41, anchor 40 is released from grasper 55, but cable 33 is still coupled with implant tube 34. As such, cable 33 is used for guiding grasper 55 and grasper tube 52 aligned with axis 53 of implant tube 34. This alignment allows the attachment of anchor 40 to the walls 81 and 82 of septum 80 while tightly controlling the positioning of axis 53 of implant tube 34 relative to walls 81 and 82 of septum 80. In other words, even though typically septum 80 does not have a straight shape, cable 33 serves as a guidewire to position tube 34 of implant 24 approximately parallel to axis 53, and thereby, approximately perpendicular to septum 80.Reference is now made to Fig. 6. In some embodiments, delivery system 23 is configured to be decoupled from implant 24 by cable 33 being rotated in a direction 98, in the present example, counterclockwise. Subsequently, cable 33 is being pulled in direction 54, out of heart 28. Cable 33 is further configured to have sufficient mechanical flexibility for being navigated into the right atrium of heart 28 through the vasculature of patient 30. In the present example, cable 33 is made from stainless steel, but in other embodiments, cable 33 may comprise any suitable material other than stainless steel.

[0057] In some embodiments, system 23 comprises a biocompatible lubricant 84, such as but not limited to silicon oil applied in screw 99. The biocompatible lubricant 84 is configured to reduce friction in the screw 99, and thereby, to reduce the torque (also referred to herein as moment of force) required for unscrewing and detaching cable 33 from implant 24 in direction 98. In the present example, the silicon oil comprises MED-363@50cP product supplied by NuSil Technology, LLC (1050 Cindy Lane. Carpinteria, CA 93013), and the torque required to unscrew and detach cable 33 from implant 24 is between about 0.005 Newton centimeter (N cm) and 0.02 N cm. In the present example, cable 33 has torque between about 1 N cm and 10 N cm along its entire length, which is sufficient torque (e.g., more than two orders of magnitude than the torque required) to unscrew screw 99, and thereby, to decoupled between implant 24 and delivery system 23.

[0058] In some embodiments, cable 33 is configured to serve as a guidewire to tube 34 (as described above) and to mesh 41 of anchor 40, such that in response to the separation between arms 88 (shown in inset 56 of Fig. 4 above), ring 66 and mesh 41 are guided by cable 33 in direction 58 toward section 31 and the intended position of mesh 41 on the wall 82 of the right atrium. Moreover, ring 66 has a trench 67, so that arms 88 of grasper 55 are configured to (i) grasp ring 66, as shown in Figs. 2A and 3 A, (ii) release ring 66 when being separated by spreader 77, and (iii) re-place arms 88 in contact with one another to close grasper 55 and push ring in direction 58, as shown and described in detail in inset 59 of Fig. 5 above.

[0059] In some embodiments, the biocompatible ring 66 is coupled with mesh 41, and therefore, remains together with anchor 40 of implant 24 in heart 28. More specifically, ring 66 is being moved in direction 58 by being: (i) pulled by mesh 41, and (ii) pushed by arms 88 of grasper 55, and thereby, ring 66 slides over screw 99 and being used to improve the coupling between mesh 41 and the right wall 82 of the interatrial septum 80 of heart 28. It is noted that typically grasper 55 is moved in direction 58 after ring 66 slides over screw 99, so as to improve the coupling between mesh 41 and the right wall 82 of the interatrial septum 80. As described in Fig. 3B above, buffer 43 is configured to electrically decouple between marker 93 and mesh 41.This configuration prevents the formation of a Faraday cage, thereby allowing the necessary level of communication between external unit 32 and implant 24.

[0060] Fig. 7 is a flow chart that schematically illustrates a method for delivering and implanting implant 24 in heart 28, in accordance with an embodiment of the present invention.

[0061] The method begins at an insertion step 100, with inserting (and moving along direction 58) the distal portion of implant 24 (e.g., pressure sensor 38 section 29 and a portion of tube 34), in a collapsed position, through interatrial septum 80 of heart 28, as described in detail in Figs.

[0062] 1, 2 A and 2B above.

[0063] At a distal mesh opening step 102, (i) implant 24 is extracted out of the sheath to partially open distal mesh 39 of anchor 40, as described in Fig. 3A above, and (ii) at least cable 33 is moved in direction 54 to place mesh 39 in contact with wall 81 of septum 80, as described in detail in Figs. 1, 3 A and 3B above.

[0064] At a grasper moving step 104, the cardiologist moves grasper tube 52 and grasper 55 in direction 58 relative to spreader 77 to (i) open arms 88 of grasper 55 and release ring 66 connected to proximal mesh 41 of anchor 40, and subsequently, (ii) close arms 88 of grasper 55 and move ring 66 distally to open proximal mesh 41 of anchor 40 to a fully extended position and place mesh 41in contact with right wall 82 of septum 80, as described in detail in Figs. 1, 5 and 6 above.

[0065] At a decoupling step 106 that concludes the method, cable 33 is rotated (e.g., counterclockwise) to decouple cable 33 from implant 24, and cable 33 is moved along direction 54 and pulled out of heart 28, as described in detail in Fig. 6 above.

[0066] Although the embodiments described herein mainly address delivering and implanting an implant in the interatrial septum of patient heart, the methods and systems described herein can also be used in other applications, such as in other sorts of implants in which the delivery system is attached to the body of an implant at one interface and to an anchor in a second interface

[0067] It will thus be appreciated that the embodiments described above are cited by way of example, and that 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 sub-combinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art. Documents incorporated by reference in the present patent application are to be considered an integral part of the application except that to the extent any terms are defined in these incorporated documents in a manner thatconflicts with the definitions made explicitly or implicitly in the present specification, only the definitions in the present specification should be considered.

Claims

AMENDED CLAIMSreceived by the International Bureau on 11 May 2026 (11.05.2026).

1. An implant delivery system, comprising:a cable configured to be (i) coupled to the implant and moved for delivering the implant to an intended position, and (ii) decoupled from the implant at the intended position;a grasper, which is hollow and configured to be moved along the cable, the grasper comprising (i) a first section having a first inner lateral dimension (LD), (ii) a second section having a second inner LD smaller than the first inner LD of the first section, and (iii) multiple arms that are configured to grasp the implant when in a closed position, and to release the implant when in an opened position while the implant is coupled to the cable;a spreader, which is coupled to the cable and has an outer LD that is smaller than the inner LD of the first section but larger than the inner LD of the second section, the spreader configured to be moved by the cable, relative to the grasper, between the first and second sections of the grasper, to place the arms of the grasper in the closed position when moved to the first section, and in the opened position when moved to the second section; anda grasper tube, which is hollow and having a third inner LD larger than the outer LD of the spreader, the grasper tube is coupled to the grasper and configured to be moved, along the cable along first and second directions opposite to one another, for moving the grasper, wherein in response to moving the cable, relative to the grasper, along the second direction, the spreader is moved through the second section into the grasper tube and the grasper resumes the closed position but does not grasp the implant.

2. The system according to claim 1, wherein the implant comprises an anchor having first and second meshes arranged in (i) a collapsed position for insertion along the first direction into an organ of a patient, and (ii) an extended position for attaching the first and second meshes to first and second sides of a septum of the organ, respectively, further comprising a connector, which is hollow, coupled to the second mesh and configured to be moved along the cable, wherein in the closed position the grasper is configured to grasp the connector and retain the second mesh in the collapsed position.

3. The system according to claim 2, wherein after the grasper resumes the closed position without grasping the implant, the grasper is configured to move the connector along the first direction to open the second mesh to the extended position and to place the second mesh in contact with the second side of the septum.

4. The system according to claim 3, further comprising a handle positioned out of the organ and configured to (i) move the cable and the grasper tube independently from one another along the first and second directions, and (ii) decouple the cable from the implant.

5. The system according to claim 4, wherein the handle is configured to (i) perform a rotational movement about an axis, and (ii) convert the rotational movement to a linear movement of at least one of the cable and the grasper.

6. The system according to claim 4, further comprising a screw assembly having first and second parts configured to couple and decouple between the cable and the implant, respectively, wherein the handle is configured to apply an additional rotational movement to unscrew the first part from the second part.

7. The system according to claim 6, further comprising a biocompatible lubricant disposed between the first and second parts of the screw assembly.

8. The system according to claim 6, wherein after delivering the implant to the intended position, the handle is configured to: (i) open the first mesh to the extended position by extracting the implant out of a sheath and moving the cable along the second direction, and (ii) place the first mesh, in the extended position, in contact with the first side of the septum by further moving at least the cable along the second direction.

9. The system according to claim 6, wherein the handle is configured to slide the connector along the first direction over the screw assembly, and subsequently, to apply the grasper to move the connector along the first direction to open the second mesh and to place the second mesh in contact with the second side of the septum.

10. The system according to any of claims 2-9, wherein the cable is configured to guide the connector to position the second mesh at the intended position on the second side of the septum.

11. The system according to any of claims 2-9, wherein the implant comprises a blood pressure measurement device configured to measure blood pressure in an atrium of a heart.

12. The system according to any of claims 2-9, further comprising a marker, which is disposed over and at least partially encircling the connector, the marker is positioned at a proximal end of the anchor, and configured to provide an indication of (i) a location of the connector relative to the grasper, and (ii) a degree of the opening of the second mesh.

13. The system according to claim 12, wherein the marker comprises a radiopaque marker configured to be visible under X-ray imaging.

14. The system according to claim 12, further comprising a buffer disposed over and at least partially encircling the connector, the buffer is configured to prevent electrical coupling between the marker and the second mesh.

15. A method, comprising:inserting into an organ of a patient (a) a cable coupled to (i) a spreader and (ii) an implant comprising an anchor having first and second meshes in a collapsed position, and (b) a grasper grasping the implant and sliding along the cable, and moving the cable and the grasper along a first direction to an intended position of the implant in a septum of the organ, wherein the grasper comprises (i) a first section having a first inner lateral dimension (LD), (ii) a second section having a second inner LD smaller than the first inner LD of the first section, and (iii) multiple arms, wherein the spreader has an outer LD that is smaller than the inner LD of the first section but larger than the inner LD of the second section, and wherein the grasper is coupled to a grasper tube, which is threaded over the cable and having a third inner LD larger than the outer LD of the spreader;opening the first mesh to an extended position and moving at least the cable along a second direction opposite the first direction to place the first mesh in contact with a first side of the septum; andmoving the grasper along the first direction relative to the spreader and the implant, while the implant is coupled to the cable for (i) placing the grasper in an opened position and releasing the implant from the grasper by moving the arms, (ii) placing the grasper in a closed position after releasing the implant by moving the spreader through the grasper tube, (iii) opening the second mesh to an extended position, and (iv) placing the second mesh in contact with a second side of the septum.

16. The method according to claim 15, further comprising a connector, which is threaded over the cable and coupled to the second mesh, wherein inserting the implant into the organ comprises grasping the connector by the grasper and moving the grasper and the connector along the first direction while retaining the second mesh in the collapsed position.

17. The method according to claim 16, wherein moving the grasper along the first direction relative to the spreader and the implant comprises (i) releasing the connector from the grasperby placing the grasper in the opened position, and (ii) after placing the grasper in the closed position, moving the connector by the grasper along the first direction for (a) opening the second mesh to the extended position, and (b) placing the second mesh in contact with the second side of the septum.

18. The method according to claim 17, further comprising a radiopaque marker, which is disposed over and at least partially encircling the connector, wherein the marker is positioned at a proximal end of the anchor, and wherein moving the grasper along the first direction comprises receiving, under X-ray imaging, an indication of (i) a location of the connector relative to the grasper, and (ii) a degree of the opening of the second mesh.

19. The method according to claim 17, wherein inserting and moving the cable and the grasper comprises applying a handle positioned out of the organ for moving the cable and the grasper tube independently from one another along the first and second directions.

20. The method according to any of claims 15-19, further comprising decoupling the cable from the implant after attaching the first and second meshes of the anchor to the first and second sides of the septum, respectively.

21. The method according to claim 20, further comprising a screw assembly having first and second parts coupled to the cable and the implant, respectively, and wherein decoupling the cable from the implant comprises applying a rotational movement to unscrew the first part from the second part.

22. The method according to claim 16, wherein moving the grasper comprises guiding the grasper and the connector along the cable to position the second mesh at the intended position on the second side of the septum.

23. The method according to any of claims 15-19, wherein inserting the implant comprises inserting a blood pressure measurement device for measuring blood pressure in an atrium of a heart.

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