# US 2023/0404530 A1 · Pelvic floor diagnostic-therapeutic treatment chair > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2023/0404530 A1 - Document ID: US20230404530A1 - Status: Published application - Kind: A1 - Application number: 18/034,873 - Filed: 2021-11-03 - Published: 2023-12-21 - Earliest claimed: 2020-11-03 - Assignees: Nina Medical Ltd - Applicants: Nina Medical Ltd. - Inventors: Shmuel BEN-EZRA; Yoni HERTZBERG; Alexander VOLOVICK - Web page: https://patentgrep.com/patent/US20230404530A1 ## CPC - A61B 8/08: Clinical applications (A61B8/02, A61B8/04, A61B8/06 take precedence) - A61B 8/429: {characterised by determining or monitoring the contact between the transducer and the tissue} - A61B 8/085: {for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules} - A61B 8/40: {Positioning of patients, e.g. means for holding or immobilising parts of the patient's body} - A61B 8/4209: {by using holders, e.g. positioning frames} - A61B 8/4218: {characterised by articulated arms} - A61B 8/4281: {characterised by sound-transmitting media or devices for coupling the transducer to the tissue} - A61B 8/4461: {Features of the scanning mechanism, e.g. for moving the transducer within the housing of the probe} - A61B 8/463: {characterised by displaying multiple images or images and diagnostic data on one display} - A61B 8/464: {involving a plurality of displays} - A61B 8/467: {characterised by special input means} - A61B 8/5207: {involving processing of raw data to produce diagnostic data, e.g. for generating an image} - A61N 7/02: Localised ultrasound hyperthermia - A61B 8/42: {Details of probe positioning or probe attachment to the patient} - A61N 2007/0082: {Scanning transducers} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract A treatment head (20, 20′) includes an ultrasound imaging probe (22) which generates a sonogram (24) of internal anatomy of a subject (25), and a HIFU transducer 26 which emits HIFU energy (31) into the subject. A chair (28) includes a chair-frame (30) and a seat (32). When the subject is sitting in the chair, a perineum (34) of the subject is acoustically coupled to the treatment head. Control circuitry (36) (a) controls movement of the treatment head relative to the seat, (b) operates the ultrasound imaging probe to generate at least one sonogram of internal anatomy of the subject through the perineum of the subject, and (c) operates the HIFU transducer to emit HIFU energy into the body of the subject through the perineum of the subject. Other embodiments are also described. ## Claims ### Claim 1 Apparatus for use with a subject, the apparatus comprising: a treatment head comprising: an ultrasound imaging probe configured to generate a sonogram of internal anatomy of the subject by generating an imaging acoustic field; and a high intensity focused ultrasound (HIFU) transducer configured to generate a therapeutic acoustic field by emitting HIFU energy into the subject; a chair comprising a chair-frame and a seat, wherein the chair-frame, the seat, and the treatment head are arranged such that when the subject is sitting in the chair a perineum of the subject is acoustically coupled to the treatment head; and control circuitry configured to (a) control movement of the treatment head relative to the seat, (b) operate the ultrasound imaging probe to generate at least one sonogram of internal anatomy of the subject through the perineum of the subject, and (c) operate the HIFU transducer to emit HIFU energy into the body of the subject through the perineum of the subject. ### Claim 2 (depends on 1) The apparatus according to claim 1, wherein the treatment head is moveably coupled to the chair-frame. ### Claim 3 (depends on 1, 2) The apparatus according to any one of claims 1-2, wherein the HIFU transducer and the ultrasound imaging probe are fixed to the treatment head such that movement of the treatment head relative to the seat moves the HIFU transducer and the ultrasound imaging probe relative to the seat. ### Claim 4 (depends on 3) The apparatus according to claim 3, wherein the control circuitry is configured to control translation of the treatment head along a longitudinal axis of the treatment head, and along an axis that is perpendicular to the longitudinal axis. ### Claim 5 (depends on 3) The apparatus according to claim 3, wherein the control circuitry is configured to control rotation of the treatment head about an axis that is perpendicular to a longitudinal axis of the treatment head. ### Claim 6 (depends on 3) The apparatus according to claim 3, wherein the control circuitry is configured to control rotation of the treatment head about a longitudinal axis of the treatment head. ### Claim 7 (depends on 3) The apparatus according to claim 3, wherein the ultrasound imaging probe is configured to rotate relative to the treatment head about a longitudinal axis of the treatment head, and wherein the control circuitry is further configured to control the rotation of the ultrasound imaging probe relative to the treatment head. ### Claim 8 (depends on 7) The apparatus according to claim 7, wherein the HIFU transducer and the ultrasound imaging probe are coaxial, and the ultrasound imaging probe is configured to rotate within a central bore of the HIFU transducer. ### Claim 9 (depends on 1, 2) The apparatus according to any one of claims 1-2, wherein the treatment head comprises: a housing, in which the ultrasound imaging probe and the HIFU transducer are disposed; and a flexible membrane sealably coupled to a perimeter of the housing, the flexible membrane and the housing forming an internal cavity that is configured to be filled with a liquid such that, when the internal cavity of the housing is filled with the liquid the ultrasound imaging probe and the HIFU transducer are in direct contact with the liquid, wherein: the flexible membrane is configured to inflate outwards from the perimeter of the housing due to pressure from the liquid within the internal cavity, and when the subject is sitting in the chair the perineum of the subject is acoustically coupled to the treatment head via the flexible membrane, the flexible membrane being pressed against the perineum of the subject due to the pressure. ### Claim 10 (depends on 9) The apparatus according to claim 9, wherein the liquid is degassed water. ### Claim 11 (depends on 9) The apparatus according to claim 9, wherein at least a portion of the flexible membrane is water permeable and is configured such that when the flexible membrane is pressed against the perineum of the subject, liquid from within the internal cavity of the housing seeps through the at least a portion of the flexible membrane such that the perineum is acoustically coupled to the flexible membrane via the liquid that seeped through the at least a portion of the flexible membrane. ### Claim 12 (depends on 9) The apparatus according to claim 9, wherein the flexible membrane is arranged such that a major axis of a projection of the uninflated flexible membrane taken along a longitudinal axis of the treatment head of is 6-12 cm. ### Claim 13 (depends on 12) The apparatus according to claim 12, wherein the flexible membrane is arranged such that the major axis of the projection of the uninflated flexible membrane taken along the longitudinal axis of the treatment head is 2-8 cm longer than a major axis of the perimeter of the housing to which the flexible membrane is sealably coupled. ### Claim 14 (depends on 12) The apparatus according to claim 12, wherein the flexible membrane is arranged such that the major axis of the projection of the uninflated flexible membrane taken along the longitudinal axis of the treatment head is 20-100% larger than a major axis of the perimeter of the housing to which the flexible membrane is sealably coupled. ### Claim 15 (depends on 9) The apparatus according to claim 9, further comprising a pressure regulator coupled to the housing and configured to regulate the pressure within the internal cavity of the housing. ### Claim 16 (depends on 15) The apparatus according to claim 15, wherein: the housing comprises a fluid port in fluid communication with the internal cavity of the housing, and the pressure regulator is configured to regulate the pressure within the internal cavity of the housing by regulating a volume of the liquid within the internal cavity of the housing using the fluid port. ### Claim 17 (depends on 16) The apparatus according to claim 16, wherein: the fluid port is a first fluid port and the housing further comprises a second fluid port, (a) the first fluid port being a fluid inlet port through which the liquid is received into the internal cavity of the housing, (b) the second fluid port being a fluid outlet port through which the liquid is drained from the internal cavity of the housing, and the pressure regulator is configured to regulate the pressure within the internal cavity of the housing by regulating a volume of the liquid within the internal cavity of the housing using the fluid inlet port and the fluid outlet port. ### Claim 18 (depends on 16) The apparatus according to claim 16, wherein the flexible membrane is coupled to the housing such that (a) when the flexible membrane is inflated by the internal cavity of the housing being filled with a volume of liquid such that the pressure within the internal cavity is 1.2 atm, and (b) the subject is not sitting in the chair, an uncompressed height of the inflated flexible membrane along a longitudinal axis of the treatment head is 2-12 cm. ### Claim 19 (depends on 18) The apparatus according to claim 18, wherein the pressure regulator is configured such that, when the subject is sitting in the chair, the pressure regulator maintains the flexible membrane pressed against the perineum of the subject by maintaining the pressure within the internal cavity at an operational pressure. ### Claim 20 (depends on 19) The apparatus according to claim 19, wherein the operational pressure is 1.2-2 atm. ### Claim 21 (depends on 19) The apparatus according to claim 19, wherein the pressure regulator is configured such that, when the subject is sitting in the chair, during motion of the treatment head relative to the seat, the pressure regulator maintains the flexible membrane pressed against the perineum of the subject by maintaining the pressure within the internal cavity at the operational pressure. ### Claim 22 (depends on 21) The apparatus according to claim 21, wherein the flexible membrane and the housing of the treatment head are arranged such that when (a) the subject is sitting in the chair and (b) the pressure regulator is maintaining the pressure at the operational pressure during the motion of the treatment head relative to the seat, the treatment head can translate along the longitudinal axis of the treatment head at least 1 cm away from the perineum of the subject without the flexible membrane losing contact with the perineum of the subject. ### Claim 23 (depends on 21) The apparatus according to claim 21, wherein the flexible membrane and the housing of the treatment head are arranged such that when (a) the subject is sitting in the chair and (b) the pressure regulator is maintaining the pressure at the operational pressure during the motion of the treatment head relative to the seat, the treatment head can translate at least 1 cm along an axis that is perpendicular to the longitudinal axis of the treatment head without a contact portion of the flexible membrane that is in contact with the perineum of the subject sliding with respect to the perineum of the subject. ### Claim 24 (depends on 21) The apparatus according to claim 21, wherein the flexible membrane and the housing of the treatment head are arranged such that when (a) the subject is sitting in the chair and (b) the pressure regulator is maintaining the pressure at the operational pressure during the motion of the treatment head relative to the seat, the treatment head can rotate by at least 5 degrees about an axis that is perpendicular to the longitudinal axis of the treatment head without a contact portion of the flexible membrane that is in contact with the perineum of the subject sliding with respect to the perineum of the subject. ### Claim 25 (depends on 1, 2) The apparatus according to any one of claims 1-2, further comprising a robotic arm, the treatment head being coupled to a distal end of the robotic arm, wherein the control circuitry is configured to control movement of the treatment head relative to the seat by controlling movement of the robotic arm. ### Claim 26 (depends on 25) The apparatus according to claim 25, wherein a proximal end of the robotic arm is coupled to the chair-frame. ### Claim 27 (depends on 25) The apparatus according to claim 25, wherein the robotic arm is configured to move the treatment head in a plurality of degrees of freedom. ### Claim 28 (depends on 27) The apparatus according to claim 27, wherein the HIFU transducer and the ultrasound imaging probe are fixed to the treatment head such that movement of the treatment head relative to the seat moves the HIFU transducer and the ultrasound imaging probe relative to the seat. ### Claim 29 (depends on 28) The apparatus according to claim 28, wherein the robotic arm is configured to translate the treatment head along a longitudinal axis of the treatment head, and along an axis that is perpendicular to the longitudinal axis. ### Claim 30 (depends on 28) The apparatus according to claim 28, wherein the robotic arm is configured to rotate the treatment head about an axis that is perpendicular to a longitudinal axis of the treatment head. ### Claim 31 (depends on 28) The apparatus according to claim 28, wherein the robotic arm is configured to rotate the treatment head about a longitudinal axis of the treatment head. ### Claim 32 (depends on 28) The apparatus according to claim 28, wherein the ultrasound imaging probe is configured to rotate relative to the treatment head about a longitudinal axis of the treatment head, and wherein the robotic arm is further configured to control the rotation of the ultrasound imaging probe relative to the treatment head. ### Claim 33 (depends on 32) The apparatus according to claim 32, wherein the HIFU transducer and the ultrasound imaging probe are coaxial, and the ultrasound imaging probe is configured to rotate within a central bore of the HIFU transducer. ### Claim 34 (depends on 1, 2) The apparatus according to any one of claims 1-2, wherein the control circuitry is configured to register the imaging acoustic field and the therapeutic acoustic field, such that the imaging acoustic field and the therapeutic acoustic field share a common coordinate system. ### Claim 35 (depends on 34) The apparatus according to claim 34, wherein the apparatus is for use with a display and, due to the registration of the imaging acoustic field and the therapeutic acoustic field, the control circuitry is configured to show on the display (a) the sonogram of the internal anatomy of the subject and (b) a focal region of the HIFU energy with respect to the internal anatomy of the subject overlaid on the sonogram of the internal anatomy of the subject on the display. ### Claim 36 (depends on 35) The apparatus according to claim 35, wherein the display is a first display configured to be used by a practitioner, the apparatus is further for use with a second display disposed such that the second display is visible to the subject when the subject is sitting in the chair, and the control circuitry is configured to display on the second display spatial information based on (a) the sonogram of the internal anatomy of the subject and (b) a focal region of the HIFU energy with respect to the internal anatomy of the subject. ### Claim 37 (depends on 36) The apparatus according to claim 36, wherein the control circuitry is configured to display the spatial information by displaying a spatial relationship between internal anatomy of the subject and the focal region of the HIFU energy with respect to the internal anatomy of the subject. ### Claim 38 (depends on 36) The apparatus according to claim 36, wherein the control circuitry is configured to display (a) the sonogram of the internal anatomy of the subject and (b) a focal region of the HIFU energy with respect to the internal anatomy of the subject overlaid on the sonogram of the internal anatomy of the subject. ### Claim 39 (depends on 36) The apparatus according to claim 36, wherein the second display is coupled to the chair-frame. ### Claim 40 (depends on 36) The apparatus according to claim 36, wherein the control circuitry is configured to display an indication to the subject relating to a progression of a procedure that the subject is undergoing, the procedure being performed via the treatment head. ### Claim 41 (depends on 40) The apparatus according to claim 40, wherein the control circuitry is configured to display the indication by displaying an alert to the subject on the second display if the focal region of the HIFU energy has moved with respect to internal anatomy of the subject due to movement of the subject with respect to the seat. ### Claim 42 (depends on 1, 2) The apparatus according to any one of claims 1-2, wherein the control circuitry comprises user controls configured to be used by the subject when the subject is sitting in the chair in order to provide feedback to the practitioner relating to a sensation that the subject is experiencing. ### Claim 43 (depends on 42) The apparatus according to claim 42, wherein the user controls comprise a stop-actuator which the subject can actuate while sitting in the chair, the stop-actuator being configured to terminate the emission of HIFU energy into the subject. ### Claim 44 (depends on 1, 2) The apparatus according to any one of claims 1-2, wherein the treatment head comprises: a housing, in which the ultrasound imaging probe and the HIFU transducer are disposed; and a flexible membrane sealably coupled to a perimeter of the housing, the flexible membrane and the housing forming an internal cavity that is filled with a volume of liquid such that the ultrasound imaging probe and the HIFU transducer are in direct contact with the liquid, wherein: the flexible membrane is inflated outwards from the perimeter of the housing due to pressure from the liquid within the internal cavity, and when the subject is sitting in the chair the perineum of the subject is acoustically coupled to the treatment head via the flexible membrane, the flexible membrane being pressed against the perineum of the subject due to the pressure. ### Claim 45 (depends on 44) The apparatus according to claim 44, wherein at least a portion of the flexible membrane is water permeable and is configured such that when the flexible membrane is pressed against the perineum of the subject, liquid from within the internal cavity of the housing seeps through the at least a portion of the flexible membrane such that the perineum is acoustically coupled to the flexible membrane via the liquid that seeped through the at least a portion of the flexible membrane. ### Claim 46 (depends on 44) The apparatus according to claim 44, wherein the flexible membrane is coupled to the housing such that the pressure within the internal cavity is 1.2-2 atm, and is configured such that when the subject is not sitting in the chair, an uncompressed height of the inflated flexible membrane along a longitudinal axis of the treatment head is 2-4 cm. ### Claim 47 (depends on 46) The apparatus according to claim 46, wherein the flexible membrane is arranged such that a major axis of a projection of the inflated flexible membrane taken along a longitudinal axis of the treatment head when the subject is not sitting in the chair of is 6-12 cm. ### Claim 48 (depends on 47) The apparatus according to claim 47, wherein the flexible membrane is arranged such that the major axis of the projection of the inflated flexible membrane taken along the longitudinal axis of the treatment head when the subject is not sitting in the chair is 2-8 cm longer than a major axis of the perimeter of the housing to which the flexible membrane is sealably coupled. ### Claim 49 (depends on 47) The apparatus according to claim 47, wherein the flexible membrane is arranged such that the major axis of the projection of the inflated flexible membrane taken along the longitudinal axis of the treatment head when the subject is not sitting in the chair is 20-100% larger than a major axis of the perimeter of the housing to which the flexible membrane is sealably coupled. ### Claim 50 (depends on 46) The apparatus according to claim 46, wherein the control circuitry is configured such that, when the subject is sitting in the chair, during motion of the treatment head relative to the seat, the control circuitry maintains the flexible membrane pressed against the perineum of the subject. ### Claim 51 (depends on 50) The apparatus according to claim 50, wherein the control circuitry is configured such that, when the subject is sitting in the chair, during motion of the treatment head relative to the seat, the control circuitry regulates the pressure within the internal cavity by regulating a force with which the flexible membrane is pressed against the perineum. ### Claim 52 (depends on 50) The apparatus according to claim 50, wherein the flexible membrane and the housing of the treatment head are arranged such that when (a) the subject is sitting in the chair and (b) the control circuitry is maintaining the flexible membrane pressed against the perineum of the subject during motion of the treatment head relative to the seat, the treatment head can translate at least 1 cm along an axis that is perpendicular to the longitudinal axis of the treatment head without a contact portion of the flexible membrane that is in contact with the perineum of the subject sliding with respect to the perineum of the subject. ### Claim 53 (depends on 50) The apparatus according to claim 50, wherein the flexible membrane and the housing of the treatment head are arranged such that when (a) the subject is sitting in the chair and (b) the control circuitry is maintaining the flexible membrane pressed against the perineum of the subject during motion of the treatment head relative to the seat, the treatment head can rotate by at least 5 degrees about an axis that is perpendicular to the longitudinal axis of the treatment head without a contact portion of the flexible membrane that is in contact with the perineum of the subject sliding with respect to the perineum of the subject. ### Claim 54 (depends on 44) The apparatus according to claim 44, wherein the flexible membrane is an elastic membrane, and wherein the elastic membrane is (a) coupled to the housing such that the pressure within the internal cavity is 1.2-2 atm, and (b) configured such that when the subject is not sitting in the chair, an uncompressed height of the inflated elastic membrane along a longitudinal axis of the treatment head is 2-12 cm. ### Claim 55 (depends on 54) The apparatus according to claim 54, wherein the elastic membrane is arranged such that a major axis of a projection of the inflated elastic membrane taken along a longitudinal axis of the treatment head when the subject is not sitting in the chair of is 6-12 cm. ### Claim 56 (depends on 55) The apparatus according to claim 55, wherein the elastic membrane is arranged such that the major axis of the projection of the inflated elastic membrane taken along the longitudinal axis of the treatment head when the subject is not sitting in the chair is 2-8 cm longer than a major axis of the perimeter of the housing to which the elastic membrane is sealably coupled. ### Claim 57 (depends on 55) The apparatus according to claim 55, wherein the elastic membrane is arranged such that the major axis of the projection of the inflated elastic membrane taken along the longitudinal axis of the treatment head when the subject is not sitting in the chair is 20-100% larger than a major axis of the perimeter of the housing to which the elastic membrane is sealably coupled. ### Claim 58 (depends on 54) The apparatus according to claim 54, wherein the control circuitry is configured such that, when the subject is sitting in the chair, during motion of the treatment head relative to the seat, the control circuitry maintains the elastic membrane pressed against the perineum of the subject. ### Claim 59 (depends on 58) The apparatus according to claim 58, wherein the control circuitry is configured such that, when the subject is sitting in the chair, during motion of the treatment head relative to the seat, the control circuitry regulates the pressure within the internal cavity by regulating a force with which the elastic membrane is pressed against the perineum. ### Claim 60 (depends on 58) The apparatus according to claim 58, wherein the elastic membrane and the housing of the treatment head are arranged such that when (a) the subject is sitting in the chair and (b) the control circuitry is maintaining the elastic membrane pressed against the perineum of the subject during motion of the treatment head relative to the seat, the treatment head can translate along the longitudinal axis of the treatment head at least 1 cm away from the perineum of the subject without the elastic membrane losing contact with the perineum of the subject. ### Claim 61 (depends on 58) The apparatus according to claim 58, wherein the elastic membrane and the housing of the treatment head are arranged such that when (a) the subject is sitting in the chair and (b) the control circuitry is maintaining the elastic membrane pressed against the perineum of the subject during motion of the treatment head relative to the seat, the treatment head can translate at least 1 cm along an axis that is perpendicular to the longitudinal axis of the treatment head without a contact portion of the elastic membrane that is in contact with the perineum of the subject sliding with respect to the perineum of the subject. ### Claim 62 (depends on 58) The apparatus according to claim 58, wherein the elastic membrane and the housing of the treatment head are arranged such that when (a) the subject is sitting in the chair and (b) the control circuitry is maintaining the elastic membrane pressed against the perineum of the subject during motion of the treatment head relative to the seat, the treatment head can rotate by at least 5 degrees about an axis that is perpendicular to the longitudinal axis of the treatment head without a contact portion of the elastic membrane that is in contact with the perineum of the subject sliding with respect to the perineum of the subject.