WO2011013127A2 - Structures d'occlusion de l'artère utérine - Google Patents

Structures d'occlusion de l'artère utérine Download PDF

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Publication number
WO2011013127A2
WO2011013127A2 PCT/IL2010/000610 IL2010000610W WO2011013127A2 WO 2011013127 A2 WO2011013127 A2 WO 2011013127A2 IL 2010000610 W IL2010000610 W IL 2010000610W WO 2011013127 A2 WO2011013127 A2 WO 2011013127A2
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WO
WIPO (PCT)
Prior art keywords
subject
rod
fornix
uterine artery
uterine
Prior art date
Application number
PCT/IL2010/000610
Other languages
English (en)
Other versions
WO2011013127A3 (fr
Inventor
Yossi Gross
Eliahu Eliachar
Dan Sade Hochstadter
Jacob Cohen
Herman Weiss
Nir Lilach
Original Assignee
Fibro Control, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US12/509,732 external-priority patent/US8403953B2/en
Application filed by Fibro Control, Inc. filed Critical Fibro Control, Inc.
Priority to EP10804003A priority Critical patent/EP2459080A2/fr
Publication of WO2011013127A2 publication Critical patent/WO2011013127A2/fr
Publication of WO2011013127A3 publication Critical patent/WO2011013127A3/fr
Priority to US13/352,894 priority patent/US20120136369A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/1459—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/132—Tourniquets
    • A61B17/135—Tourniquets inflatable
    • A61B17/1355—Automated control means therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22067—Blocking; Occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22069—Immobilising; Stabilising
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A61B2090/065—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension for measuring contact or contact pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B7/00—Instruments for auscultation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1047—Balloon catheters with special features or adapted for special applications having centering means, e.g. balloons having an appropriate shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1072—Balloon catheters with special features or adapted for special applications having balloons with two or more compartments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible

Definitions

  • Applications of the present invention generally relate to medical apparatus. Specifically, applications of the present invention relate to apparatus and methods for occluding a subject's uterine arteries. BACKGROUND
  • Uterine fibroids are benign tumors of muscle and connective tissue that develop within, or are attached to, the uterine wall.
  • US 2009/0093758 to Gross and US 2009/0318950 to Gross describe apparatus including a tube that is configured to pass into a patient's vagina and to penetrate vaginal tissue until a distal tip of the tube is outside of a uterine artery of the patient, but in a vicinity of a portion of the uterine artery that supplies a uterine fibroid.
  • a balloon, disposed at the distal tip, is inflated to cause local squeezing of the portion of the uterine artery to an extent sufficient to occlude the uterine artery.
  • Flostat vascular Control Systems
  • the primary element of the Flostat system is a Doppler guided clamp designed for bilateral temporary occlusion of the uterine arteries.
  • the device is currently indicated for use during conservative gynecologic procedures such as laparoscopic myomectomy.
  • US Patents 6,254,601 and 6,602,251 both to Burbank et al., describe devices and methods for treating a uterine disorder which receives its blood supply from a uterine artery.
  • uterine fibroids are described as being treated by occluding the uterine arteries using trans-vaginal, trans-uterine, transrectal, or retroperitoneal approaches.
  • the devices and methods are described as being used by a patient's gynecologist in the course of treatment, avoiding the need for referrals to specialist practitioners and for more radical treatments, such as hysterectomies.
  • the methods include both temporary and permanent occlusion of the arteries.
  • a cannula is described as carrying an imaging device and a member which will penetrate tissue, the member including a device which partially or completely, and temporarily or permanently, occludes a uterine artery.
  • a uterine artery compression device is used to occlude one or both of a subject's uterine arteries.
  • the occlusion of the uterine artery is typically performed in order to reduce the supply of blood to a uterine fibroid, thereby causing irreversible ischemic necrosis and death of the fibroid.
  • a fornix-engaging structure e.g., a cervix cap
  • a fornix-engaging structure e.g., a cervix cap
  • First and second uterine artery compression devices are inserted into the subject's body, via the fornix-engaging structure.
  • the balloons are placed at sites outside of but in a vicinity of the left and right uterine arteries, respectively.
  • the balloons are typically placed at sites that are posterior to the subject's broad ligament. When the balloons are at the sites, the balloons compress, and at least partially occlude, the uterine arteries by being inflated.
  • a positioning-anchoring balloon disposed on the end of a positioning-anchoring tube, is inserted into the subject's uterus and inflated, such that the positioning-anchoring balloon stabilizes the occluding balloons.
  • a blood flow monitoring system is used to monitor blood flow through the uterine arteries.
  • oximeters of the blood flow monitoring system may be disposed on the positioning-anchoring tube and used to detect when blood flow through the uterine arteries has stopped, by detecting a level of oxyhemoglobin in the vicinity of the uterine arteries.
  • first and second rigid structures are inserted into left and right extrauterine positions anterior to the left and right broad ligaments.
  • the left and right uterine artery compression devices compress the left and right uterine arteries by squeezing tissue against, respectively, the first and second rigid structures.
  • a single uterine artery compression device is placed at a site that is posterior to the broad ligament and the single uterine artery compression device squeezes both the left and right uterine arteries, respectively, against the left and right rigid structures.
  • the compression device is coupled to the distal end of a rigid rod, which is typically hollow (i.e., it is a rigid tube), but for some applications is solid.
  • a rigid rod typically hollow (i.e., it is a rigid tube), but for some applications is solid.
  • the compression device may be a balloon that is disposed around the distal end of the rigid tube.
  • the tube is inserted into the subject's body such that the distal end of the tube passes through vaginal tissue until the distal end of the tube is at a site ("the compression site") outside of the uterine artery of the subject, but in a vicinity of a portion of the uterine artery that supplies the uterine fibroid.
  • the compression device compresses the artery.
  • the balloon is inflated such that the balloon compresses the artery.
  • the rigidity of the tube typically ensures that the position of the distal end of the tube is maintained at the compression site during the compression of the artery. In this manner, as the balloon is inflated, the balloon exerts pressure on the uterine artery, rather than pushing the distal end of the tube away from the compression site.
  • a fornix-engaging structure is inserted into the subject's vagina such that the structure engages the subject's fornix.
  • the tube is inserted through the vaginal tissue, and the distal end of the tube is positioned at the compression site using a tube-guide that is coupled to the fornix-engaging structure.
  • the tube-guide is configured such that the tube is inserted into the subject's body at an angle that is not parallel to the longitudinal axis of the fornix-engaging structure.
  • inserting the tube at such an angle facilitates placement of the distal end of the tube at the compression site.
  • the tube-guide is configured such that the tube is inserted into the subject's body parallel to the longitudinal axis of the fornix-engaging structure.
  • left and right balloons are used as the uterine artery compression device.
  • the balloons are typically inserted into the subject's body, via an incision in the subject's posterior vaginal fornix. Further typically, the balloons are inserted while the balloons are (a) in deflated states, and (b) both inside of a cover.
  • the balloons are disposed adjacent to one another, inside the cover, or at another suitable relative disposition with respect to one another.
  • the balloons are inserted into a position that is posterior to the subject's cervix. When the balloons are in this position, the cover is withdrawn from around the balloons. Subsequently, the balloons are separated from each other, while the balloons are still in deflated states.
  • the balloons are separated, such that after the balloons have been separated from each other, the balloons are positioned posterior to, respectively, the left and right broad ligaments.
  • the separation of the balloons is achieved using a mechanical mechanism that simultaneously separates the two balloons and places them posterior to the left and right broad ligaments.
  • left and right rigid structures are inserted to the anterior side of the subject's fornix such that distal ends of the respective rigid structures are at sites anterior to, respectively, the subject's left and right broad ligaments.
  • the left and right rigid structures are placed at the sites anterior to the subject's broad ligaments without penetrating (or otherwise passing through) vaginal or any other tissue of the subject.
  • a uterine artery compression device e.g., the left and right balloons described hereinabove
  • is placed posterior to the broad ligaments e.g., as described hereinabove).
  • the uterine artery compression device compresses the subject's left and right uterine arteries by pressing the left and right broad ligaments against, respectively, the left and right rigid structures.
  • balloons such as the left and right balloons described hereinabove
  • the balloons (a) are positioned posterior to, respectively, the left and right broad ligaments, as described hereinabove, and (b) are subsequently inflated, in order to press the broad ligaments against the rigid structures.
  • a fornix-engaging structure e.g., a cervix cap
  • a fornix-engaging structure is inserted into the subject's vagina such that the structure engages the subject's vaginal fornix.
  • the left and right rigid structures are inserted via the fornix-engaging structure.
  • the uterine artery compression device is inserted through vaginal tissue via the fornix- engaging structure.
  • both the rigid structures and the uterine artery compression device are passed through the fornix-engaging structure.
  • a positioning-anchoring balloon disposed on the end of a positioning-anchoring tube, is inserted into the subject's uterus, via the fornix-engaging structure.
  • the positioning-anchoring balloon is inflated.
  • the positioning-anchoring balloon stabilizes the fornix-engaging structure, and thereby stabilizes the uterine artery compression device and the rigid structures, when the uterine artery compression device and the rigid structures are subsequently inserted via the fornix- engaging structure.
  • a fornix-engaging structure a positioning- anchoring tube, and/or a positioning-anchoring rod are used, in accordance with the techniques described in US Patent application 12/509,732 to Gross, which is incorporated herein by reference.
  • apparatus for use with a body, vagina, vaginal fornix, uterus, cervix, left and right broad ligaments and left and right uterine arteries of a subject, the apparatus including:
  • left and right rigid structures configured to be inserted into the subject's fornix such that distal ends of the rigid structures are at sites anterior to perivascular adipose layers of, respectively, the subject's left and right broad ligaments;
  • At least one uterine artery compression device configured to be placed posterior to the broad ligaments and to compress the subject's left and right uterine arteries by pressing the left and right broad ligaments against, respectively, the left and right rigid structures.
  • the apparatus further includes left and right rigid-structure- support-elements, the left and right rigid structures being disposed, respectively, on the left and right rigid-structure-support-elements, the rigid-structure-support-elements being reversibly couplable to one another.
  • the apparatus further includes:
  • the uterine artery compression device being disposed at a distal end of the insertion assembly
  • a fornix-engaging structure including first and second portions thereof
  • the first portion of the fomix-engaging structure being coupled to the insertion assembly
  • the second portion of the fomix-engaging structure being configured to be couplable to the first portion of the fornix-engaging structure inside the subject's vagina.
  • the uterine artery compression device includes a spring mechanism configured to facilitate expansion of the uterine artery compression device toward the subject's broad ligaments.
  • the apparatus further includes an oximeter configured to be inserted via the subject's vagina and to measure a level of oxygen in the subject's uterus.
  • the left and right rigid structures are configured not to pass through vaginal tissue of the subject.
  • both the left and right rigid structures are configured to be inserted through a single incision in the subject's fornix.
  • the left and right rigid structures are configured to be inserted through respective incisions in the subject's fornix.
  • the apparatus further includes a fornix-engaging structure configured to be inserted into the vagina and to engage the vaginal fornix,
  • the left and right rigid structures are configured to be inserted into the subject's fornix via the fornix-engaging structure.
  • the apparatus further includes a locking-mechanism configured, subsequent to the insertion of the rigid structures via the fornix— engaging structure, to lock the rigid structures into a fixed position with respect to the fornix- engaging structure.
  • the rigid structures include curved distal portions thereof.
  • the rigid structures are not configured to incise tissue.
  • a radius of curvature of each of the curved distal portions is between 1 mm and 20 mm.
  • the radius of curvature of each of the curved distal portions is between 5 mm and 15 mm.
  • the apparatus further includes:
  • the uterine artery compression device being disposed at a distal end of the insertion assembly
  • a fomix-engaging structure including first, second, and third portions thereof, the second portion of the fornix-engaging structure being coupled to the insertion assembly,
  • the first portion of the fornix-engaging structure being configured to be couplable to the second and third of the fornix-engaging structure inside the subject's vagina.
  • the second and third portions of the fornix-engaging structure are shaped to engage a region of the first portion of the fornix-engaging structure such that motion of the first and second portion in a distal direction with respect to the first portion is prevented.
  • the third portion of the fornix-engaging structure includes left and right rigid-structure-support-elements, the left and right rigid structures being disposed, respectively, on the left and right rigid-structure-support-elements, the rigid- structure-support-elements being reversibly couplable to one another.
  • the uterine artery compression device includes left and right balloons configured to be placed at positions posterior to, respectively, the left and right broad ligaments.
  • the apparatus further includes:
  • a rigid rod that is coupled to the balloons, and that is configured to maintain the balloons in a given configuration with respect to one another by flexing the connecting member.
  • each of the balloons includes two chambers, the chambers being disposed with respect to one another, such that when the balloons are placed posterior to the broad ligaments, the balloons are configured to expand substantially in an anterior-posterior direction, upon inflation of the balloons.
  • the apparatus further includes a measuring device configured to measure a parameter that is indicative of a level of blood-flow through the subject's uterine arteries, and a control unit configured to generate an output that is indicative of the level of blood flow through the uterine arteries.
  • the measuring device includes a measuring device selected from the group consisting of an oximeter, a microphone, and a pressure sensor.
  • a method, for use with a body, vagina, vaginal fornix, uterus, cervix, left and right broad ligaments and left and right uterine arteries of a subject including: inserting left and right rigid structures into the subject's fornix such that distal ends of the rigid structures are at sites anterior to perivascular adipose layers of, respectively, the subject's left and right broad ligaments;
  • the method further includes measuring a level of oxygen in the subject's uterus, and compressing the subject's uterine arteries includes compressing the uterine arteries responsively to the measured level of oxygen.
  • apparatus for use with a body, vagina, vaginal fornix, uterus, cervix, left and right broad ligaments and left and right uterine arteries of a subject, the apparatus including:
  • At least one insertion assembly configured to be inserted into the subject's body, such that a distal end of the assembly passes through vaginal tissue until the distal end of the assembly is at a site posterior to the cervix;
  • a balloon-placement mechanism configured to place the left and right balloons posterior to, respectively, the left and right broad ligaments, when the distal end of the insertion assembly is at the site posterior to the cervix.
  • the apparatus further includes a fornix-engaging structure configured to be inserted into the vagina and to engage the vaginal fornix, and the insertion assembly is configured to be inserted via the fornix-engaging structure.
  • the apparatus further includes a fornix-engaging structure including first and second portions thereof,
  • the second portion of the fornix-engaging structure being configured to be couplable to the first portion of the fornix-engaging structure inside the subject's vagina.
  • the balloon-placement mechanism is configured to place the left and right balloons posterior to the broad ligaments by simultaneously lifting the balloons anteriorly, and separating the balloons from one another.
  • the apparatus further includes left and right rigid structures configured to be inserted into the subject's fornix, such that distal ends of the rigid structures are at sites anterior to perivascular adipose layers of, respectively, the left and right broad ligaments, and the left and right balloons are configured to compress the left and right uterine arteries by pressing the subject's broad ligaments against, respectively, the left and right rigid structures.
  • the apparatus further includes a fornix-engaging structure including first, second, and third portions thereof,
  • the third portion of the fomix-engaging structure being coupled to the rigid structures
  • the first portion of the fomix-engaging structure being configured to be couplable to the second and third of the fornix-engaging structure inside the subject's vagina.
  • a method for use with a body, vagina, vaginal fornix, uterus, cervix, left and right broad ligaments and left and right uterine arteries of a subject, the method including: inserting left and right balloons that are disposed at a distal end of an insertion assembly into the subject's body, such that the balloons pass through vaginal tissue until the balloons are at a site posterior to the cervix; and
  • apparatus including: left and right uterine artery compression devices configured to occlude, respectively, left and right uterine arteries of a subject; and
  • the apparatus further includes a rigid rod that is coupled to the uterine artery compression devices, and that is configured to maintain the uterine artery compression devices in a given configuration by flexing the flexible material.
  • the apparatus further includes at least one rigid structure configured to be placed at least in part in a vaginal fornix of the subject, and the uterine artery compression devices are configured to occlude the uterine arteries by pressing the uterine arteries against the rigid structure.
  • the apparatus further includes:
  • the compression devices being configured to be inserted through vaginal tissue of the subject, while the compression devices are (a) in deflated states thereof and (b) both inside of the cover;
  • a mechanism configured, subsequent to the compression devices having been inserted through the subject's vaginal tissue, to separate the compression devices from each other.
  • the flexible material defines a maximum distance between centers of the left and right uterine artery compression devices of 25-200 mm.
  • the flexible material defines a maximum distance between centers of the left and right uterine artery compression devices of 40-80 mm.
  • the flexible material has a length of 5-60 mm.
  • apparatus for use with a subject's body, vagina, vaginal fornix, uterus, and uterine artery, the apparatus including:
  • a fornix-engaging structure configured to be inserted into the vagina and to engage the vaginal fornix;
  • a rod configured to be inserted into the subject's body via the fornix-engaging structure, such that a distal end of the rod passes through vaginal tissue at a first vaginal site until the distal end of the rod is at a first extrauterine site outside of the uterine artery, but in a vicinity of a portion of the uterine artery that supplies a uterine fibroid;
  • a rod-guide coupled to the fornix-engaging structure, and configured to guide the distal end of the rod to the first extrauterine site;
  • a uterine artery compression device disposed on the distal end of the rod.
  • the rod is a hollow rod.
  • the rod is a solid rod.
  • the rod is shaped to prevent rotation of the rod with respect to the rod-guide.
  • the fornix-engaging structure defines a longitudinal axis thereof, and the rod-guide is shaped to define a hole for guiding the rod, a longitudinal axis of the hole being parallel to the longitudinal axis of the fornix-engaging structure.
  • the apparatus further includes a blood flow sensor configured to detect a change in blood flow through the uterine artery.
  • the apparatus further includes a positioning-anchoring rod and a positioning-anchoring balloon disposed at a distal end of the positioning-anchoring rod, and:
  • the distal end of the positioning-anchoring rod is configured to be inserted into the subject's uterus, via a cervix of the subject, and
  • the positioning-anchoring balloon is configured to anchor the uterine artery compression device while the uterine artery compression device is outside of the uterus, by the positioning-anchoring balloon being inflated while the distal end of the positioning- anchoring rod is inside the subject's uterus.
  • the fornix-engaging structure and the rod-guide are coupled by being an integrated unit.
  • the rod-guide is reversibly couplable to the fornix-engaging structure.
  • the rod-guide is configured to be coupled to the fornix- engaging structure before the fornix-engaging structure is inserted into the subject's vagina.
  • the rod-guide is configured to be coupled to the fornix- engaging structure when the fornix-engaging structure has engaged the vaginal fornix.
  • the uterine artery compression device includes a balloon.
  • the balloon is substantially not stretchable.
  • the fornix-engaging structure defines a longitudinal axis thereof, and the rod-guide is shaped to define a hole for guiding the rod, a longitudinal axis of the hole not being parallel to the longitudinal axis of the fornix-engaging structure.
  • an angle between the longitudinal axis of the rod-guide and the longitudinal axis of the hole is less than 60 degrees.
  • the angle between the longitudinal axis of the rod-guide and the longitudinal axis of the hole is between 10 degrees and 45 degrees.
  • the angle between the longitudinal axis of the rod-guide and the longitudinal axis of the hole is between 15 degrees and 30 degrees.
  • the rod includes a rigid rod.
  • the fornix-engaging structure and the rod-guide include rigid structures configured to maintain the distal end of the rod at the site by supporting the rod.
  • the apparatus further includes a rigid positioning-anchoring rod and a positioning-anchoring balloon disposed at a distal end of the positioning- anchoring rod, and:
  • the distal end of the positioning-anchoring rod is configured to be inserted into the subject's uterus, via a cervix of the subject, and
  • the positioning-anchoring balloon is configured to anchor the uterine artery compression device while the uterine artery compression device is outside of the uterus, by the positioning-anchoring balloon being inflated while the distal end of the positioning- anchoring rod is inside the subject's uterus.
  • the uterine artery compression device is configured to compress the uterine artery by squeezing tissue of the subject against a portion of the apparatus.
  • the uterine artery compression device is configured to compress the uterine artery by squeezing the subject's tissue against the fornix-engaging structure.
  • the rod includes first and second rods configured to be inserted into the subject's body, such that distal ends of the rods are at sites outside of but in a vicinity of left and right uterine arteries of the subject, respectively, and
  • the uterine artery compression device includes left and right uterine artery compression devices disposed, respectively, on the distal end of the first and second rods, and configured to compress, respectively, the left and right uterine arteries by each uterine artery compression device squeezing tissue against the other uterine artery compression device.
  • the apparatus further includes a positioning-anchoring rod and a positioning-anchoring balloon disposed at a distal end of the positioning-anchoring rod, and:
  • the distal end of the positioning-anchoring rod is configured to be inserted into the subject's uterus
  • the positioning-anchoring balloon is configured to anchor the uterine artery compression device while the uterine artery compression device is outside of the uterus, by the positioning-anchoring balloon being inflated while the distal end of the rod is inside the subject's uterus, and
  • the uterine artery compression device is configured to compress the uterine artery by squeezing the subject's tissue against the positioning-anchoring rod.
  • the apparatus further includes a positioning-anchoring rod and a positioning-anchoring balloon disposed at a distal end of the positioning-anchoring rod, and: the distal end of the positioning-anchoring rod is configured to be inserted into the subject's uterus,
  • the positioning-anchoring balloon is configured to anchor the uterine artery compression device while the uterine artery compression device is outside of the uterus, by the positioning-anchoring balloon being inflated while the distal end of the rod is inside the subject's uterus, and
  • the uterine artery compression device is configured to compress the uterine artery by squeezing the subject's tissue against the positioning-anchoring balloon.
  • the rod includes first and second rods configured to be inserted into the subject's body, such that distal ends of the rods are at left and right first extrauterine sites outside of but in a vicinity of left and right uterine arteries of the subject, respectively, and
  • the uterine artery compression device includes left and right uterine artery compression devices disposed, respectively, on the distal end of the first and second rods, and configured to compress, respectively, the left and right uterine arteries.
  • the rod-guide is shaped to define at least one guiding portion at approximately a six o'clock position with respect to the subject's uterus, and is configured to guide the first and second rods through vaginal tissue at approximately the six o'clock position, via the at least one guiding portion.
  • the rod-guide includes a first guiding portion configured to guide the distal end of the first rod to the left first extrauterine site, and a second guiding portion configured to guide the distal end of the second rod to the right first extrauterine site, and an angle defined by the first guiding portion of the rod-guide, a longitudinal axis of the rod-guide, and the second guiding portion of the rod-guide is less than 10 degrees.
  • the rod-guide is shaped to define first and second guiding portions at approximately a three o'clock position and a nine o'clock position with respect to the uterus
  • the rod-guide is configured to guide the first rod through vaginal tissue at approximately the three o'clock position, via the first guiding portion, and
  • the rod-guide is configured to guide the second rod through vaginal tissue at approximately the nine o'clock position, via the second guiding portion.
  • the rod-guide includes a first guiding portion configured to guide the distal end of the first rod to the left first extrauterine site, and a second guiding portion configured to guide the distal end of the second rod to the right first extrauterine site, and an angle defined by the first guiding portion of the rod-guide, a longitudinal axis of the rod-guide, and the second guiding portion of the rod-guide is between 170 and 190 degrees.
  • the apparatus further includes a rigid structure configured to be inserted into the subject's body via the fornix-engaging structure, such that a distal end of the rigid structure passes through vaginal tissue at a second vaginal site, until the distal end of the rigid structure is at a second extrauterine site outside of the uterine artery,
  • the uterine artery compression device is configured to compress the uterine artery by squeezing tissue of the subject against the rigid structure.
  • the rigid structure includes a curved distal portion thereof.
  • a distal portion of the rigid structure is substantially straight.
  • the rod and the rigid structure are pivotally connected to each other.
  • the rod includes first and second rods configured to be inserted into the subject's body, such that distal ends of the rods are at a first pair of extrauterine sites outside of but in a vicinity of left and right uterine arteries of the subject, respectively,
  • the uterine artery compression device includes left and right uterine artery compression devices disposed, respectively, on the distal end of the first and second rods
  • the rigid structure includes left and right rigid structures configured to be inserted into the subject's body via the fornix-engaging structure, such that the distal ends of the rigid structures are at a second pair of extrauterine sites outside of but in a vicinity of left and right uterine arteries of the subject, respectively,
  • the left uterine artery compression device is configured to compress the left uterine artery by squeezing tissue of the subject against the left rigid structure
  • the right uterine artery compression device is configured to compress the right uterine artery by squeezing tissue of the subject against the right rigid structure.
  • the rigid structure includes left and right rigid structures configured to be inserted into the subject's body via the fomix-engaging structure, such that the distal ends of the rigid structures are at second extrauterine sites outside of but in a vicinity of left and right uterine arteries of the subject, respectively, and
  • the uterine artery compression device includes a single uterine artery compression device that is configured to:
  • the rod-guide includes a first guiding portion configured to guide the distal end of the rod to the first extrauterine site, and a second guiding portion configured to guide the distal end of the rigid structure to the second extrauterine site, and an angle defined by the first guiding portion of the rod-guide, a longitudinal axis of the rod-guide, and the second guiding portion of the rod-guide is greater than 100 degrees.
  • the rod-guide includes a first guiding portion configured to guide the distal end of the rod to a first extrauterine site that is posterior to a broad ligament of the subject, and a second guiding portion configured to guide the distal end of the rigid structure to a second extrauterine site that is anterior to a perivascular adipose layer of the broad ligament.
  • the rigid structure includes a rigid solid rod.
  • the rigid structure includes a rigid hollow rod.
  • the apparatus further includes a balloon disposed on the distal end of the rigid structure.
  • the balloon is substantially not stretchable.
  • the rod-guide defines at least one guiding portion at approximately a position with respect to the subject's uterus, selected from the group consisting of: a 2 o'clock position, a 3 o'clock position, a 6 o'clock position, a 9 o'clock position, and a 10 o'clock position, and the rod-guide is configured to guide the rod and the rigid structure through vaginal tissue, via the at least one guiding portion.
  • the rod-guide includes (a) a first guiding portion at approximately a 6 o'clock position with respect to the subject's uterus, and (b) a second guiding portion at approximately a position with respect to the subject's uterus selected from the group consisting of: a 2 o'clock position and a 10 o'clock position,
  • the rod-guide is configured to guide the rod through vaginal tissue at approximately the 6 o'clock position, via the first guiding portion, and
  • the rod-guide is configured to guide the rigid structure through vaginal tissue at approximately the selected position, via the second guiding portion.
  • the rod-guide defines a first guiding portion at approximately a 2 o'clock position with respect to the subject's uterus, a second guiding portion at approximately a 10 o'clock position with respect to the subject's uterus, and a third guiding portion at approximately a 6 o'clock position with respect to the subject's uterus,
  • the rigid structure includes left and right rigid structures
  • the rod-guide is configured to guide the left rigid structure through vaginal tissue at approximately the 2 o'clock position, via the first guiding portion,
  • the rod-guide is configured to guide the right rigid structure through vaginal tissue at approximately the 10 o'clock position, via the second guiding portion, and
  • the rod-guide is configured to guide the rod through vaginal tissue at approximately the 6 o'clock position, via the third guiding portion.
  • apparatus including:
  • a rod having a telescoping distal portion thereof, and a longitudinal axis thereof;
  • the apparatus being such that when the balloon is in an inflated state thereof, the rod is configured to increase a diameter of the balloon in a direction that is perpendicular to the longitudinal axis of the rod, by the telescoping portion of the rod being shortened.
  • the rod is a hollow rod.
  • the rod is a solid rod.
  • the rod is configured to be inserted into a subject's body, such that a distal end of the rod passes through vaginal tissue, until the distal portion of the rod is at a site outside of a uterine artery of the subject, but in a vicinity of a portion of the uterine artery that supplies a uterine fibroid.
  • the balloon is configured to at least partially occlude the uterine artery by being inflated while the distal portion is at the site.
  • the balloon is configured to further occlude the uterine artery by the telescoping portion of the rod being shortened while the distal portion is at the site.
  • apparatus including:
  • a measuring device configured to measure a parameter that is indicative of a level of blood-flow through blood vessels of a subject
  • control unit configured to drive the output unit to generate an output that is (a) indicative of blood flow through a portion of one of the blood vessels having stopped due to (V) the parameter having changed and then plateaued at a value indicating non-zero blood flow in a vicinity of the blood vessels.
  • the measuring device is configured to be placed in a vicinity of a uterine artery of the subject, and the control unit is configured to drive the output unit to generate an output that is (a) indicative of blood flow through a portion of the uterine artery having stopped due to (b) the parameter having changed and then plateaued at a value indicating non-zero blood flow in the vicinity of the uterine artery.
  • the measuring device includes a pressure sensor configured to detect pressure in the vicinity of the blood vessels, and the control unit is configured to drive the output unit to generate an output that is indicative of a strength of a pulsating component of the detected pressure having decreased and then plateaued at a value indicating non-zero blood flow in the vicinity of the blood vessels.
  • the measuring device includes a microphone configured to detect sound waves in the vicinity of the blood vessels, and the control unit is configured to drive the output unit to generate an output that is indicative of a strength of a pulsating component of the detected sound waves having decreased and then plateaued at a value indicating non-zero blood flow in the vicinity of the blood vessels.
  • the measuring device includes a spectrometer.
  • the measuring device includes an oximeter.
  • apparatus for use with a subject's uterus including:
  • a rod a distal end of which is configured to be inserted into the subject's uterus; a balloon disposed on the distal end of the rod and configured to be inflated while the distal end of the rod is inside the subject's uterus; and
  • an oximeter disposed on the distal end of the rod and configured to detect a change in blood flow in a vicinity of the uterus by measuring a level of oxyhemoglobin in the vicinity while the distal end of the rod is inside the subject's uterus.
  • the rod is hollow.
  • the rod is solid.
  • apparatus including:
  • a medical tool configured to be placed inside a body of a subject, outside of a reproductive tract of the subject;
  • a positioning-anchoring balloon coupled to the tool, and configured to stabilize the tool by being inserted into a uterus of the subject and engaging the subject's uterus by the balloon being inflated.
  • the medical tool includes a uterine artery compression device.
  • apparatus for use with a subject's body, uterus, vagina and uterine artery, the apparatus including: a guide structure having a first guiding portion at a site that is at approximately a 6 o'clock position with respect to the subject's uterus, and a second guiding portion that is approximately at a position with respect to the subject's uterus selected from the group consisting of: a 2 o'clock position and a 10 o'clock position,
  • the guide structure being configured to guide the first compression device into the subject's body, via a vaginal site of the vagina that is at approximately the 6 o'clock position, via the first guiding portion, and
  • the guide structure being configured to guide the second compression device into the subject's body, via a vaginal site of the vagina that is at approximately at the selected position, via the second guiding portion
  • the first and second compression devices being configured to compress the uterine artery by each compression device squeezing tissue against the other compression device.
  • apparatus for use with a subject's vagina and uterine artery, the apparatus including:
  • first and second balloons configured to:
  • the subject's body via at least one vaginal site of the vagina, and compress the uterine artery by each balloon squeezing tissue against the other balloon.
  • one of the first and second balloons is substantially not stretchable, and another one of the first and second balloons is substantially stretchable.
  • the apparatus further includes a pressure sensor configured to detect pressure in a vicinity of the balloons by detecting pressure inside the balloon that is substantially not stretchable.
  • a rod-guide guiding the rod such that a distal end of the rod passes through vaginal tissue at a first vaginal site until the distal end of the rod is at a first extrauterine site outside of the uterine artery, but in a vicinity of a portion of the uterine artery that supplies a uterine fibroid;
  • the method further includes positioning and anchoring the uterine artery compression device while the uterine artery compression device is at the site, by placing a positioning-anchoring balloon inside the uterus and inflating the positioning- anchoring balloon while the positioning-anchoring balloon is inside the uterus.
  • inserting the rod into the subject's body includes inserting a rigid rod into the subject's body, and compressing the uterine artery using the uterine artery compression device disposed on the distal end of the rod, includes maintaining the position of the distal end of the rod at the site, using the rigidity of the rod.
  • the rod includes left and right rods
  • the uterine artery compression device includes left and right uterine artery compression devices disposed, respectively, on distal ends of the left and right rods
  • guiding the rod includes guiding the left and right rods, via left and right first vaginal sites, such that distal ends of the rods are at left and right first extrauterine sites outside of but in a vicinity of left and right uterine arteries of the subject, respectively, and compressing the uterine artery includes compressing the left and right uterine arteries, using, respectively, the left and right uterine artery compression devices.
  • guiding the left and right rods includes guiding the rods to the left and right first extrauterine sites via vaginal tissue at approximately a six o'clock position with respect to the subject's uterus.
  • guiding the left rod includes guiding the left rod to the left first extrauterine site via vaginal tissue at approximately a three o'clock position with respect to the subject's uterus
  • guiding the right rod includes guiding the right rod to the right first extrauterine site via vaginal tissue at approximately a nine o'clock position with respect to the subject's uterus.
  • the method further includes inserting a rigid structure into the subject's body via the fornix-engaging structure, such that a distal end of the rigid structure passes through vaginal tissue at a second vaginal site, until the distal end of the rigid structure is at a second extrauterine site outside of the uterine artery,
  • and compressing the uterine artery using the uterine artery compression device includes compressing the uterine artery by squeezing tissue of the subject against the rigid structure, using the uterine artery compression device.
  • guiding the rod such that the distal end of the rod is at the first extrauterine site includes guiding the rod such that the distal end of the rod is at an extrauterine site that is posterior to a broad ligament of the subject, and
  • guiding the rigid structure such that the distal end of the rigid structure is at the second extrauterine site includes guiding the distal end of the rigid structure to a second extrauterine site that is anterior to a perivascular adipose layer of the broad ligament of the subject.
  • a rod having a telescoping distal portion thereof, a longitudinal axis thereof, and a balloon disposed around the telescoping portion;
  • a measuring device placed in a vicinity of a plurality of blood vessels of a subject; using the measuring device, measuring a parameter that is indicative of a level of blood-flow through the blood vessels; and determining that blood flow through one of the blood vessels has stopped by detecting that the parameter has changed and then plateaued at a value indicating non-zero blood flow in the vicinity of the blood vessels.
  • a method for use with a subject's uterus including:
  • detecting a change in blood flow in a vicinity of the uterus by measuring a level of oxyhemoglobin in the vicinity using an oximeter that is disposed on the distal end of the elongate element, while the distal end of the elongate element is inside the subject's uterus.
  • anchoring the device by inserting a balloon into the subject's uterus and engaging the subject's uterus with the balloon by inflating the balloon, the balloon being coupled to the device.
  • a method for compressing a uterine artery of a subject including:
  • compressing the uterine artery includes avoiding occluding ureters of the subject.
  • a method for compressing a uterine artery of a subject including: providing a balloon having a first side and a second side, the first side being more flexible than the second side; and
  • left and right uterine artery compression devices occluding left and right uterine arteries of a subject using, respectively, the left and right uterine artery compression devices.
  • the flexible material defines a maximum distance between respective centers of the left and right uterine artery compression devices, and providing the left and right uterine artery compression devices includes providing the devices such that that the maximum distance is 5-25 cm.
  • occluding includes inflating the uterine artery compression devices.
  • occluding includes squeezing at least one of the uterine arteries between (a) apparatus placed into the subject and (b) one of the compression devices.
  • Fig. 1 is a schematic illustration of a device configured to at least partially occlude a subject's uterine arteries, and a bed-side system for use with the device, in accordance with some applications of the present invention
  • Fig. 2 is a schematic illustration of the device, in accordance with some applications of the present invention.
  • Figs. 3A-F are schematic illustrations of the device of Fig. 2, the device including rigid structures that are placed anterior to the subject's uterine arteries, via a rod-guide of the device, in accordance with some applications of the present invention;
  • Figs. 4A-B are schematic illustrations of a tube-guide, in accordance with some applications of the present invention.
  • Fig. 5 is a schematic illustration of the device configured to at least partially occlude a subject's uterine arteries, in accordance with some applications of the present invention
  • Figs. 6A-C are schematic illustrations of a tube-guide, in accordance with some applications of the present invention.
  • Fig. 7 is a schematic illustration of a positioning-anchoring balloon, and a positioning-anchoring tube that includes an oximetry system, in accordance with some applications of the present invention
  • Figs. 8A-C are schematic illustrations of a balloon for occluding the uterine artery, in accordance with respective applications of the present invention.
  • Figs. 9-14B are schematic illustrations of steps of a procedure for occluding a subject's uterine arteries, in accordance with some applications of the present invention.
  • Figs. 15-16 are schematic illustrations of non-penetrating rigid structures, in accordance with some applications of the present application.
  • Figs. 17A-B are schematic illustrations of a locking mechanism for locking penetrating and non-penetrating rigid structures, in unlocked (17A) and locked (17B) states, in accordance with some applications of the present invention
  • Figs. 18A-G are schematic illustrations of non-penetrating rigid structures, in accordance with respective applications of the present invention
  • Figs. 19-24B are schematic illustrations of steps of a procedure for occluding a subject's uterine arteries using a two-portion fornix-engaging structure, in accordance with some applications of the present invention
  • Fig. 25 is a schematic illustration of a three-portion fornix-engaging structure, in accordance with some applications of the present invention.
  • Figs. 26-39 are schematic illustrations of steps of a procedure that is used with the three-portion fornix-engaging structure, in accordance with some applications of the present invention.
  • Figs. 40A-G are schematic illustrations of decouplable rigid-structure-support- elements, in accordance with some applications of the present invention.
  • FIGS. 4 IA-G are schematic illustrations of left and right balloons that are used as a uterine artery compression device, in accordance with some applications of the present invention.
  • Figs. 42A-B are schematic illustrations of a first portion of the three-portion fornix- engaging structure, in accordance with some applications of the present invention.
  • Figs. 43A-C are schematic illustrations of the three-portion fomix-engaging structure, in accordance with some applications of the present invention.
  • Figs. 44A-B are schematic illustrations of apparatus for occluding uterine arteries, including one or more double-chambered balloons, in accordance with some applications of the present invention
  • Figs. 45A-D are schematic illustrations of a double-chambered balloon, in accordance with some applications of the present invention.
  • Figs. 46A-C are schematic illustrations of a double-chambered balloon, in accordance with some applications of the present invention. DETAILED DESCRIPTION OF EMBODIMENTS
  • Fig. 1 is a schematic illustration of a device 20 configured to at least partially occlude a subject's uterine arteries 21, in accordance with some applications of the present invention.
  • the occlusion of the uterine arteries is typically performed in order to reduce the supply of blood to uterine fibroids 31, thereby causing irreversible ischemic necrosis and death of the fibroids.
  • a fornix-engaging structure 24 is inserted into the subject's vagina 27, such that it engages the vaginal fornix 45. Subsequently, an incision 22 is made in the vaginal wall. (Although the incision in the vaginal wall is shown at 3 o'clock and 9 o'clock positions, for some applications, incision 22 is made at other positions on the vaginal wall, for example, at a 6 o'clock, a 2 o'clock, and/or a 10 o'clock position, as described in further detail hereinbelow.) A tube-guide 26 (which is described in further detail hereinbelow) is coupled to fornix-engaging structure 24.
  • a uterine artery compression device for example, a balloon 28 (as shown), is disposed on the distal end of a tube 29.
  • a solid rod is used in place of tube 29 (i.e., a hollow rod), mutatis mutandis).
  • the tube is inserted into the subject's body, and the tube-guide guides the tube such that the distal end of the tube passes through vaginal tissue until the distal end of the tube is at a site 30 that is adjacent to the subject's cervix 35, e.g., above the subject's fornix 45, and below the subject's uterus 23.
  • Site 30 is typically outside of uterine artery 21 , but in a vicinity of a portion of the uterine artery that supplies uterine fibroid 31. Site 30 is typically posterior to the subject's broad ligament 53.
  • the tube is typically inserted via incision 22. While the distal end of the tube is at site 30, the uterine compression device is used to compress, and at least partially occlude the subject's uterine artery. For example, while the distal end of the tube is at site 30, the balloon is inflated in order to occlude the uterine artery.
  • guide structure is used in the present application.
  • a “tube guide” is a type of “rod guide”
  • a “rod guide” is a type of “guide structure.”
  • the scope of the present invention includes using any rod guide (e.g., a solid rod guide) in place of a tube guide, for applications in which the use of a tube guide is described, mutatis mutandis.
  • a bed-side system 10 of device 20 typically includes control units 52 for controlling inflation of balloons of device 20, and a monitor (not shown) that displays readings of sensors (e.g., pressure sensors 48, microphones 46, and/or oximeters 40 (shown in Fig. 7)) that sense parameters associated with the device, as described in further detail hereinbelow.
  • sensors e.g., pressure sensors 48, microphones 46, and/or oximeters 40 (shown in Fig. 7)
  • the distal end of tube 29 is blunt, for applications in which tube 29 is inserted via incisions that have previously been made in the vaginal tissue, as described hereinabove.
  • the distal end of tube 29 is sharp, and is used to penetrate the vaginal tissue by forming incisions in the vaginal tissue.
  • the sharp distal end is folded subsequent to the penetration of the vaginal tissue by the distal end of the tube.
  • techniques that are known in the art are used for folding the sharp distal end of the tube.
  • tube-guide 26 and fomix-engaging structure 24 are coupled to each other, such that they form a single integrated unit at the time of manufacture, i.e., the fornix-engaging structure includes a guiding structure for guiding tube 29, and/or other portions of device 20.
  • the fornix-engaging structure may define one or more holes that are configured to guide portions of device 20.
  • the tube-guide and the fornix-engaging structure are reversibly couplable to each other (e.g., as shown in Fig. 4A).
  • tube 29 is inserted into the subject's body, via the fornix- engaging structure, prior to the tube-guide being coupled to the fornix-engaging structure.
  • tube-guide is coupled to the fornix-engaging structure, thereby guiding the distal end of the tube-guide to site 30.
  • tube 29 prior to the tube-guide being coupled to the fornix-engaging structure, tube 29 is able to rotate with respect to the fornix-engaging structure.
  • the size of hole 35 in the fornix-engaging structure is substantially larger than the cross-section of the tube.
  • the tube is inhibited by the tube-guide from rotating with respect to the fornix-engaging structure.
  • the shape and size of hole 60 shown in Fig.
  • left and right balloons are inserted into sites 30 on, respectively, the left and right side of the subject's cervix.
  • the balloons are used to compress, and at least partially occlude, left and right uterine arteries of the subject, in accordance with the techniques described herein.
  • the left and right arteries are compressed simultaneously.
  • the left and right arteries are compressed at separate times.
  • apparatus and methods that are described herein, as being applied to a single uterine artery are applied to left and right uterine arteries, at least partially, simultaneously.
  • a single (posterior) incision is made at the 6 o'clock position of the fornix (i.e., a posterior colpotomy is performed at the posterior fornix), and left and right balloons 28 are inserted via the single incision.
  • Device 20, as used for such applications is shown in Figs. 2-4.
  • left and right balloons 28 are inserted into sites 30 on the left and right side of the subject's cervix via incisions 22 at approximately 3 o'clock and 9 o'clock positions of the fornix (i.e., the lateral fornix) with respect to the subject's uterus.
  • Device 20, as used for such applications is shown in Figs. 5 and 6A-C.
  • colpotomy refers to an incision in a subject's vaginal tissue.
  • anterior colpotomy andposterior colpotomy refer respectively to incisions in the vaginal tissue at approximately 12 o'clock and 6 o'clock positions.
  • a positioning-anchoring balloon 32 disposed at the distal end of a positioning-anchoring tube 34 is inserted into the subject's uterus, via the subject's cervix.
  • a solid rod is used in place of tube 34 (which is a hollow rod), mutatis mutandis.)
  • the intrauterine positioning-anchoring balloon is inflated while it is disposed in the uterus, in order to position and then anchor device 20.
  • balloon 32 may be used to position and anchor extrauterine compression balloons 28 with respect to the subject's cervix and uterine arteries.
  • a balloon that is similar to the silicone balloon of The Rumi System® is used as the intrauterine balloon.
  • the length of the positioning-anchoring tube with respect to the fornix-engaging structure is adjustable.
  • the positioning-anchoring tube may be threadedly coupled to the fornix-engaging structure and/or the tube-guide, such that the height of the positioning-anchoring tube with respect to the fornix-engaging structure is controlled by screwing the positioning-anchoring tube through the fornix-engaging structure and/or the tube-guide.
  • a positioning-anchoring balloon that is inserted into a subject's uterus and which, by engaging the subject's uterus by being inflated, positions, and then anchors a medical tool that is in an extrauterine location within the subject's body.
  • uterine artery 21 is compressed due to each of left and right balloons 28 squeezing (i.e., forcing) tissue toward the other balloon.
  • one or both of balloons 28 squeeze tissue against positioning-anchoring tube 34, and/or positioning-anchoring balloon 32.
  • one or both of balloons 28 squeeze tissue against fomix-engaging structure 24.
  • balloon 28 compresses the uterine artery by generally causing compression of tissue in the vicinity of the balloon, and without squeezing the subject's tissue against another portion of device 20.
  • first and second rigid structures 51 are inserted into left and right extrauterine positions anterior to the left and right broad ligaments (as shown in Fig. 3B).
  • rigid structures 51 are uterine artery compression devices.
  • the left and right uterine artery compression devices 28 are inserted into left and right extrauterine positions posterior to the left and right broad ligaments.
  • the left and right uterine artery compression devices 28 compress the left and right uterine arteries by squeezing tissue against, respectively, the first and second rigid structures.
  • a single uterine artery compression device is placed at a site that is posterior to the broad ligament and the single uterine artery compression device squeezes both the left and right uterine arteries, respectively, against the left and right rigid structures (as shown in Fig. 3C).
  • tube 29 is a rigid tube.
  • the rigidity of the tube maintains the position of the distal end of the tube at site 30, while balloon 28 is inflated and compresses the uterine artery. (If tube 29 were not rigid, then some of the inflation of the balloon would be in effect wasted. In some cases, this might cause the tube to bend away from the uterine artery, such that the balloon does not have sufficient compressive effect to occlude the uterine arteries.)
  • tube 29 is flexible, for example, during insertion of the tube through the vagina, but becomes rigid for compressing the uterine artery.
  • fornix-engaging structure 24, tube-guide 26, and positioning-anchoring tube 34 are also rigid.
  • Fig. 2 is a schematic illustration of device 20, in accordance with some applications of the present invention.
  • a single incision is made in the vaginal tissue at approximately the 6 o'clock position, and left and right tubes 29 and balloons 28 are inserted via the single incision.
  • Tube-guide 26 defines two holes 60 (shown in Fig. 4A) at approximately the 6 o'clock position. Tubes
  • 29L and 29R are both inserted through the incision in the vaginal tissue at the 6 o'clock position by fornix-engaging structure 24 being pushed against the subject's fornix, and the tubes being inserted through a hole 35 in structure 24.
  • tube-guide 26 is coupled to structure 24 via coupling elements 33.
  • the tube- guide guides left and right tubes 29L and 29R to their respective positions, by being coupled to the fornix-engaging structure.
  • the distal ends of tubes 29L and 29R are appropriately shaped for balloons 28L and 28R to be positioned adjacent to left and right uterine arteries 2 IL and 2 IR posterior to broad ligaments 53 by being inserted through the incision at the 6 o'clock position.
  • FIGs. 3A-F are schematic illustrations of device 20 including rigid structures 51, in accordance with some applications of the invention.
  • rigid structures 51 are solid rods, or hollow rods (i.e., tubes).
  • incisions are made at approximately the 2 o'clock and 10 o'clock positions of the vaginal fornix.
  • Left rigid structure 51 L is inserted to an extrauterine site that is anterior to the broad ligament in the vicinity of left uterine artery 2 IL (shown in Fig. 3B), via the 2 o'clock incision.
  • right rigid structure 5 IR is inserted to an extrauterine site that is anterior to the broad ligament in the vicinity of right uterine artery 2 IR (also shown in
  • Left and right extrauterine sites of the left and right rigid structures are typically anterior to, respectively, the subject's left and right broad ligaments 53.
  • left and right rigid structures 5 IL and 5 IR are inserted into the subject's body via fornix-engaging structure 24. Subsequently, tube-guide 26 is coupled to the fornix-engaging structure and guides the rigid structures to their respective sites.
  • uterine artery compression device 28 includes left and right uterine artery compression devices 28L and 28R.
  • the left uterine artery compression device compresses left uterine artery 2 IL, by squeezing the subject's broad ligament and the uterine artery against left rigid structure 5 IL, as shown in Fig. 3B.
  • the right uterine artery compression device compresses right uterine artery 2 IR, by squeezing the subject's broad ligament and the uterine artery against right rigid structure 5 IR, also as shown in Fig. 3B.
  • the compression of the uterine arteries is thus performed in an anterior-posterior direction, and not in a lateral direction.
  • the subject's uterine arteries are compressed in a lateral direction.
  • using rigid structures 5 IL and 5 IR in addition to the uterine artery compression device facilitates compression of the uterine arteries, as the rigid structures provide resistance against which to push the uterine arteries.
  • inserting the rigid structures at the 2 o'clock and 10 o'clock positions ensures that the rigid structures are inserted to sites that are anterior to the broad ligaments.
  • left and right uterine artery compression devices 28 are balloons that are coupled to at least one flexible connecting member 74, as shown in Fig. 3C, and as described in detail hereinbelow.
  • uterine artery compression device 28 is a single uterine artery compression device, for example, a curved balloon, as shown in Fig. 3D.
  • the uterine artery compression device compresses left and right uterine arteries by squeezing the broad ligament and the uterine arteries against, respectively, left and right rigid structure 5 IL and 5 IR.
  • balloons 55L and 55R are disposed on the distal ends of, respectively, rigid structure 5 IL and rigid structure 5 IR, as shown in Fig. 3E.
  • the balloons facilitate compression of the uterine arteries, and/or facilitate measurement of the pressure in the vicinity of the uterine arteries, as described in further detail hereinbelow.
  • balloons 55 are uterine artery compression devices.
  • distal portions of rigid structures 5 IL and 5 IR are curved, as shown in Fig. 3F, to facilitate insertion of the structures to suitable extrauterine sites.
  • the distal portions of the rigid structures are substantially straight, as shown in Fig. 3 A.
  • left rigid structure 5 IL and left tube 29L are pivotally connected to each other, e.g., structure 5 IL and tube 29L may comprise a clamp (pivot not shown).
  • right rigid structure 5 IR and right tube 29R are pivotally connected to each other.
  • left rigid structure 5 IL and left tube 29L, and/or right rigid structure 5 IR and right tube 29R act as a hemostat.
  • Figs. 3A-F Fig. 4A being a schematic illustration of fornix-engaging structure 24 and tube-guide 26 in a decoupled state, in accordance with an application of the present invention.
  • device 20 is placed inside the subject's body in accordance with the following procedure:
  • Positioning-anchoring tube 34 and positioning-anchoring balloon 32 are coupled to fornix-engaging structure 24.
  • fornix-engaging structure 24 is inserted into the subject's vagina such that it engages the subject's fornix, and such that the distal end of positioning-anchoring tube 34 and the balloon 32 are placed inside the subject's uterus, via the subject's cervix.
  • Positioning-anchoring balloon 32 is inflated so as to position and anchor the fornix-engaging structure.
  • Tube-guide 26 is coupled to the fornix-engaging structure, via coupling elements 33. During the coupling of the tube-guide to the fornix-engaging structure, tubes
  • Balloons 28 on the distal ends of tubes 29 are inflated such that the left and right uterine arteries are compressed, by the broad ligaments and uterine arteries being compressed against the rigid structures.
  • Fig. 4B is a schematic top-view illustration of tube-guide 26, in accordance with some applications of the invention.
  • an angle theta defined by hole 6 IL (through which rigid structure 5 IL is guided), longitudinal axis 64 of the tube-guide, and hole 6OL (through which tube 29L is guided), is greater than 100 degrees.
  • the angle defined by hole 6 IR (through which rigid structure 5 IR is guided), longitudinal axis 64 of the tube-guide, and hole 6OR (through which tube 29R is guided) is greater than 100 degrees.
  • 60R is less than 10 degrees.
  • Fig. 5 is a schematic illustration of device 20, in accordance with some applications of the present invention.
  • left and right balloons 28L and 28R are inserted into sites on both the left and right side of the subject's cervix via incisions 22 at approximately 3 o'clock and 9 o'clock positions with respect to the subject's uterus.
  • Device 20, as used for such applications, is shown in Fig. 5.
  • Fornix-engaging structure 24 and tube-guide 26 each define holes at the 3 o'clock and 9 o'clock positions.
  • Tubes 29L and 29R are inserted through incisions in the vaginal tissue at the 3 o'clock and 9 o'clock positions by fornix- engaging structure 24 being pushed against the subject's fornix, and the tubes being inserted through the holes in the structure.
  • tube-guide 26 is coupled to structure 24, via coupling elements 33.
  • the tube-guide guides left and right tubes 29L and 29R to their respective positions, by being coupled to the fornix-engaging structure.
  • Figs. 6A-C are schematic illustrations of components of device 20, in accordance with some applications of the present invention.
  • the fornix-engaging structure 24 and tube-guide 26, shown in Figs. 6A-C are typically used in techniques in which incisions 22 are made in the vaginal tissue at approximately 3 o'clock and 9 o'clock positions with respect to the subject's uterus (i.e., as shown in Fig. 5).
  • some of the elements of device 20 described with reference to Figs. 6A-C are also used with the fornix-engaging structure and tube-guide as described elsewhere in this application.
  • device 20 is placed inside the subject's body in accordance with the following procedure:
  • Positioning-anchoring tube 34 and positioning-anchoring balloon 32 are coupled to fornix-engaging structure 24.
  • fornix-engaging structure 24 Before or after step (1), fornix-engaging structure 24, is inserted into the subject's vagina such that it engages the subject's fornix, and such that the distal end of positioning-anchoring tube 34 and balloon 32 are placed inside the subject's uterus, via the subject's cervix.
  • Positioning-anchoring balloon 32 is inflated so as to position and anchor the fornix-engaging structure.
  • Left and right tubes 29 are inserted into the extrauterine space inside the subject's body, via, respectively, the 3 o'clock and 9 o'clock incisions in the fornix.
  • Tube-guide 26 is coupled to the fornix-engaging structure, via coupling elements 33. During the coupling of the tube-guide to the fornix-engaging structure, tubes
  • the tube-guide guides the tubes to their respective intra-procedural sites.
  • Balloons 28 on the distal ends of tubes 29 are inflated such that the left and right uterine arteries are compressed, typically, by tissue being compressed against a portion of device 20, e.g., positioning-anchoring tube 34.
  • longitudinal axis 62 of hole 60 is not parallel to longitudinal axis 64 of the fornix-engaging structure.
  • axis 62 may be at an angle beta of even as large as 60 degrees, although beta is typically less than 60 degrees, e.g., 10 degrees to 45 degrees from axis 64, for example, 15 degrees to 30 degrees from axis 64.
  • tube 29 is inserted into the subject's body at an angle to axis 64. For some applications, this ensures that the distal end of tube 29 becomes positioned in a suitable position for balloon 28 to occlude the subject's uterine artery.
  • tube 29 the length of tube 29 that protrudes from structure 24 into the subject's body is between 1 cm and 6 cm.
  • tube 29 includes a stopper (not shown) at its distal end, in order to prevent the tube from being inserted too far through the tube-guide.
  • a stopper may be used as described in PCT Publication WO 08/012802 to Gross, which is incorporated herein by reference, mutatis mutandis.
  • tube-guide 26 defines a further hole 66 (shown in Fig. 6C), through which positioning-anchoring tube 34 is inserted into the subject's uterus.
  • positioning-anchoring tube 34 includes a stop at its distal end in order to prevent the positioning-anchoring tube from being inserted too far through the tube-guide.
  • hole 60 is not circular. (Alternatively, hole 60 is circular.)
  • tube 29 is shaped such that the cross-section of tube 29 has the same shape as that of hole 60. Further typically, tube 29 and hole 60 are shaped so as to prevent tube 29 from rotating with respect to tube-guide 26.
  • angle alpha defined by left hole 6OL in tube-guide 26, longitudinal axis 64 of the tube-guide, and right hole 60R in tube-guide 26, is between 170 and 190 degrees.
  • device 20 includes one or more sensors for monitoring blood flow, in order to evaluate the occlusion of the uterine artery.
  • a microphone 46 detects sound waves that are generated from the uterine artery at site 30 (shown in Fig. 1), and/or at balloon 55 (application not shown), and/or a pressure sensor 48 detects the pressure inside balloon 28 (shown in Fig. 1), balloon 32 (shown in Fig. 1), and/or balloons 55 (application not shown).
  • one or more of the sensors are coupled to positioning- anchoring tube 34.
  • device 20 may include one or more oximeters 40, which are coupled to positioning-anchoring tube 34, as shown.
  • the oximeters emit light (e.g., red and infrared light) toward the cervix, or toward tissue in the vicinity of the cervix, and detect the light that is reflected from the cervix, or from the tissue.
  • light is emitted in the direction of arrows 42, and light that is reflected in the direction of arrows 44 is detected.
  • the emitted and reflected beams of light are parallel to each other.
  • a pulse oximeter control unit 49 (shown in Fig. 1) is typically configured to detect capillary flow in the uterine arteries, the uterus, and/or the cervix by the oximeter detecting a level of oxyhemoglobin and/or deoxyhemoglobin in the cervix, hi response thereto, the pulse oximeter control unit typically generates an output that is displayed on a monitor (not shown) of bed-side system 10 (shown in Fig. 1).
  • a physician modulates the pressure inside balloon 28 responsively to one or more of the parameters detected by the sensors.
  • the physician may modulate the pressure using a pump 50 (shown in Fig. 1) that is in fluid communication with balloon 28, in response to one or more of the parameters detected by the sensors (or a parameter derived therefrom) being displayed on an output unit.
  • a control unit 52 (shown in Fig. 1) modulates the pressure of balloon 28 responsively to the detected parameters, in order to achieve occlusion of the uterine artery.
  • the techniques described herein for monitoring and modulating the pressure of balloon 28 are used for monitoring and modulating the pressure of positioning- anchoring balloon 32. (It is noted that, although separate control units are shown in Fig.
  • a single control unit is used to monitor and/or modulate the pressure in two or more of the balloons.
  • the techniques described herein for monitoring and modulating the pressure of balloon 28 are used for monitoring and modulating the pressure of balloons 55L and 55R (application not shown).
  • control unit 52 determines that blood flow through the uterine artery has stopped by detecting that there is zero blood flow in the vicinity of a sensor.
  • the sensors described herein detect non-zero blood flow in the vicinity of the sensor, even when the portion of the uterine artery that is downstream of the occlusion is fully occluded. This is due to blood flow through other blood vessels in the vicinity, and/or due to blood motion in the portion of the artery that is upstream of the occlusion and that continues to empty and fill, even when the artery is occluded.
  • control unit 52 determines that blood flow through the uterine artery has stopped by detecting that a value that (a) is associated with the parameter detected by one of the sensors, and (b) is indicative of blood flow in the vicinity, has changed and then plateaued at a value indicating non-zero blood flow through at least one other of the blood vessels and/or due to blood flow through the portion of the uterine artery that is upstream of the occlusion.
  • the value of the parameter still includes a cyclical time-varying component.
  • plateau should be interpreted as including a value that may include a cyclical time-varying component, but that has changed and plateaued relative to an original value.
  • control unit determines that the uterine artery is occluded by determining that light detected by oximeter 40 indicates that a level of oxyhemoglobin in the vicinity of the subject's uterine artery has decreased and then plateaued at a non-zero value. This is indicative of the fact that blood-flow through the uterine artery has stopped, but there is non-zero blood flow through other blood vessels in the vicinity of the uterine artery and/or due to blood motion through the portion of the uterine artery that is upstream of the occlusion.
  • control unit may determine that the uterine artery is occluded in response to a pulsating component of the balloon pressure that is detected by pressure sensor 48.
  • a pulsating component of the balloon pressure that is detected by pressure sensor 48.
  • balloon 28 is inflated at site 30, or balloon 55 is inflated, initially a pulsating component of the pressure signal begins to be detected, and then the strength of the pulsating component increases, as the balloon makes contact with the uterine artery, or tissue that is adjacent to the uterine artery. Subsequently, the strength of the pulsating component decreases as the uterine artery becomes occluded.
  • pressure sensor 48 detects a non-zero pulsating component, due to blood flow through other blood vessels in the vicinity of the uterine artery and/or due to blood motion through the portion of the uterine artery that is upstream of the occlusion.
  • balloon 28, balloon 32, and/or balloon 55 is made of a non- stretchable material, such as reinforced nylon, polyurethane, and/or a similar material, in order to facilitate accurate pressure measurements of the balloon by pressure sensor 48.
  • the non-stretchable balloon is configured not to reach its maximum volume, but rather to be volume restricted by the tissue in the vicinity of the balloon. Therefore, the pressure required to inflate the balloon is equal to the pressure in the volume-restricting surrounding tissue.
  • the non-stretchable balloon facilitates monitoring the pressure of the tissue surrounding the balloon.
  • the occlusion of the uterine artery is monitored utilizing an electronic system similar to systems utilized in common blood pressure monitoring systems, in which a non-stretchable balloon is inflated while being volume restricted between the arm and an outer fabric sleeve.
  • a non-stretchable balloon is inflated while being volume restricted between the arm and an outer fabric sleeve.
  • the non- stretchable balloon is inserted into the subject's body in a deflated state.
  • the non-stretchable balloon is folded during insertion of the balloon into the subject's body, in order to enable passage of the balloon through small incisions.
  • the deflated volume and longitudinal footprint of a non-stretchable balloon are larger than those of a stretchable balloon that has the same maximum volume.
  • the tissue-contacting surface of the balloon is typically not smooth. Rather, the surface typically includes unopened folds of the material.
  • balloon 28, balloon 32, and/or balloon 55 is made of a stretchable material, such as latex, silicone, and/or similar materials.
  • a stretchable balloon typically does not facilitate accurate blood pressure monitoring of the arteries that are in the vicinity of the balloon (although the measurements may in any case be sufficiently accurate for identifying occlusion).
  • Using a stretchable balloon typically facilitates insertion of the balloon via a small incision, since the deflated volume and longitudinal footprint of the deflated stretchable balloon are small compared with those of a non-stretchable balloon.
  • a stretchable balloon typically inflates in a generally smooth and uniform manner.
  • balloon 28, balloon 32, and/or balloon 55 is made from two materials.
  • a non-stretchable sheet may be welded to a stretchable sheet, so as to enable stretching of the balloon in a first direction (e.g., toward the uterine arteries), while inhibiting stretching of the balloon in a second direction (embodiment not shown).
  • the scope of the present invention includes using for balloon 28, balloon 32, and/or balloon 55 any combination of stretchable, non-stretchable, stiff, and/or other types of materials, as would be apparent to one skilled in the art.
  • one or more of balloons 28, 32, and 55 is made of a non- stretchable material, in order to facilitate accurate pressure measurements of the balloon by pressure sensor 48, and one or more of the other balloons of balloons 28, 32, and 55 is made of a stretchable material, such as latex.
  • control unit determines that the uterine artery is occluded, in response to a pulsating component of sound waves detected by microphone 46 decreasing in value and plateauing at a non-zero-value.
  • the microphone detects a non-zero pulsating component of the sound waves due to blood flow through other blood vessels in the vicinity of the uterine artery and/or due to blood motion through the portion of the uterine artery that is upstream of the occlusion.
  • Figs. 8A-C are schematic illustrations of a balloon 28 for occluding the uterine artery, in accordance with an application of the present invention.
  • a balloon as is known in the prior art is used as uterine artery compression device 28 of device 20.
  • the scope of the present invention is not limited to using balloons as described in Figs. 8A-C for the uterine artery compression device of device 20.
  • the scope of the present invention includes using a balloon that is disposed in a non-coaxial position at the distal end of tube 29, to occlude that uterine artery.
  • tube 29 includes a telescoping portion 70 at a distal end thereof.
  • balloon 28 is inflated.
  • the telescoping portion is shortened, for example, by the distal end of the tube being retracted proximally, in the direction of arrow 72.
  • shortening the telescoping portion causes the balloon to become more elliptical, and for the diameter D of the balloon to increase in a direction that is perpendicular to the longitudinal axis of tube 29.
  • increasing the diameter of the balloon in this direction is performed in this manner, in order to further compress the uterine artery.
  • Fig. 8C is a schematic illustration of left and right balloons 28, in accordance with some applications of the present invention.
  • the left and right balloons are inserted into the subject's body via a single vaginal incision, for example, at the 6 o'clock position, as described with reference to Fig. 3A-E.
  • the balloons are coupled to a flexible connecting member 74 that is non-stretchable, and that couples the two balloons to each other, as shown in Fig. 8C.
  • connecting member 74 defines a maximum distance between respective centers of the left and right uterine balloons of, for example 5-25 cm, e.g., 12 cm.
  • connecting member 74 is stretchable, or comprises a combination of stretchable and non-stretchable materials.
  • connecting member 74 is made of reinforced nylon, polyurethane, and/or a similar material.
  • the connecting member typically ensures that the inflation of the balloons is substantially on the other side of each of the balloons to the side that is coupled to the connecting member.
  • the connecting member typically correctly positions each of the balloons with respect to the other balloon, as described in further detail hereinbelow.
  • a plurality of pieces of connecting member 74 e.g. 2-10 strips of connecting member 74
  • a single connecting member connects the left and right balloons.
  • Figs. 9-14 are schematic illustrations of respective steps of a procedure for occluding a subject's uterine arteries 21 using device 20 (shown in an assembled configuration thereof in Fig. 15), in accordance with some applications of the present invention.
  • Fornix-engaging structure 24 of device 20, as shown in Figs. 9-14 is generally similar to fornix-engaging structure 24 described hereinabove.
  • fornix-engaging structure 24, as shown in Figs. 9-14 comprises a guiding structure, for example, for guiding an insertion structure 82 of the device.
  • positioning-anchoring balloon 32 which is disposed at the distal end of positioning-anchoring tube 34, is inserted into the subject's uterus 23, via the subject's cervix 25 and vagina 27.
  • the positioning-anchoring balloon and tube are used to stabilize the fomix-engaging structure, in accordance with the techniques described herein and in US Patent Application 12/509,732 to Gross, which is incorporated herein by reference.
  • positioning-anchoring tube 34 includes at least one oximeter 40 (described with reference to Fig.
  • Positioning-anchoring balloon 32 is inflated inside the subject's uterus, as shown.
  • fornix-engaging structure 24 is advanced over positioning-anchoring tube 34 into the subject's fornix 45.
  • the position of the fornix cap is typically locked (longitudinally and angularly), with respect to positioning-anchoring tube 34.
  • An incision is made in the subject's fornix, at approximately a 6 o'clock position, i.e., on the posterior side of fornix 45. For some applications, incisions are additionally made at approximately 2 o'clock and 10 o'clock positions in the subject's fornix, for reasons described hereinbelow.
  • Left and right balloons 28L and 28R are inserted through tissue into a position posterior to cervix 25, via the 6 o'clock incision in the subject's fornix.
  • the balloons are inserted while the balloons are (a) in deflated states, and (b) both inside of a cover 80.
  • the balloons are disposed adjacent to one another, inside the cover, or at another suitable relative disposition with respect to one another, such that the balloons can be inserted simultaneously through a single 6 o'clock incision in the fornix.
  • An insertion assembly 82 is used to insert the balloons, the insertion assembly being guided by a guide.
  • the guide for guiding insertion assembly 82 is defined by the fornix-engaging structure (as shown), or is coupled to the fornix-engaging structure.
  • insertion assembly 82 is locked with respect to positioning-anchoring tube 34.
  • insertion assembly 82 is locked with respect to fornix-engaging structure 24.
  • left and right rigid structures 5 IL and 5 IR are inserted through, respectively, the 2 o'clock incision and the 10 o'clock incision in the subject's fornix.
  • the distal ends of left and right rigid structures 5 IL and 5 IR are sharp, and are used to penetrate the vaginal tissue by forming incisions in the vaginal tissue.
  • the left and right rigid structures are inserted through the subject's vaginal tissue to positions, respectively, anterior to left broad ligament 53L (shown in Fig. 12) and right broad ligament 53R.
  • cover 80 (shown covering the balloons in Fig. 11) is withdrawn from balloons 28L and 28R.
  • the cover may be withdrawn by pulling a string that is coupled to the cover, as described hereinbelow.
  • the cover instead of cover 80 being withdrawn from balloons 28L and 28R, the cover is torn along its length, for example, along a pre-perforated line.
  • the cover is removed from the balloons by another mechanism.
  • the cover is flexible, and may be, for example, a sheath.
  • left and right rods 84L and 84R to which balloons 28L and 28R are connected, are lifted anteriorly and are separated from each other by being moved respectively to left and right sides of the cervix.
  • a knob 86 shown in Fig, 13B
  • the turning of the knob actuates a mechanism 88 to separate the rods 84L and 84R from one another by moving the rods sideways, and to lift the rods anteriorly.
  • the lifting and separation of rods 84L and 84R is such that, subsequent to the lifting and separation, balloons 28L and 28R are positioned posterior to, respectively, left and right broad ligaments 53L and 53R.
  • left and right balloons 28L and 28R are typically coupled to each other by a flexible connecting member 74, for example, as described hereinabove.
  • the flexible material defines the maximum distance D between the centers of the left and right balloons.
  • the flexible material is sized such that the maximum distance between the centers is 25-200 mm, e.g., 40-80 mm.
  • the length Ll of the flexible material may be 5-60 mm.
  • one or a plurality of pieces of connecting member 74 connect the left and right balloons.
  • the connecting member typically stabilizes the positions of the balloons with respect to one another.
  • connecting member 74 is stretchable, or comprises a combination of stretchable and non-stretchable materials.
  • connecting member 74 is stretchable, or comprises a combination of stretchable and non-stretchable materials.
  • the connecting member facilitates correct positioning of each of the balloons with respect to the other balloon and restricts the balloons from rotating around rods 84 during inflation of the balloons, as described in further detail hereinbelow.
  • balloons 28L and 28R are inflated.
  • the inflated balloons press the subject's broad ligaments 53L, 53R against rigid structures 51L, 51R (shown in Fig. 14B), thereby compressing and occluding the subject's uterine arteries.
  • Figs. 15-16 are schematic illustrations of device 20 including non-penetrating rigid structures 9OL and 9OR for facilitating the occlusion of a subject's uterine arteries, in accordance with some applications of the present application.
  • the non-penetrating rigid structures perform a generally similar function to rigid structures 5 IL and 5 IR, described hereinabove. That is to say that the non-penetrating rigid structures are positioned anterior to the subject's broad ligaments and provide resistance and/or clamping support against which a uterine artery compression device (e.g., balloons 28L and 28R described hereinabove) presses the subject's broad ligaments.
  • a uterine artery compression device e.g., balloons 28L and 28R described hereinabove
  • non-penetrating rigid structures differ from rigid structures 5 IL and 5 IR in that the non-penetrating rigid structures are positioned anterior to the subject's broad ligaments, without penetrating (or otherwise passing through) vaginal tissue. Rather the non-penetrating rigid structures stretch the fornix into positions anterior to the subject's broad ligaments.
  • non-penetrating rigid structures 9OL and 9OR have distal portions that are curved.
  • the radius of curvature R of the distal portions may be 1-20 mm, e.g., 2-10 mm.
  • the incisions in the vaginal fornix at the 2 o'clock and 10 o'clock positions, described with reference to Fig. 10, are not made. Rather, the non-penetrating rigid structures are pushed distally into the vaginal fornix at the approximately 2 o'clock and 10 o'clock positions, such that they are positioned anterior to the left and right broad ligaments, while still within the vaginal fornix, by stretching the vaginal fornix.
  • a guide is used to guide non-penetrating rigid structures 9OL and 9OR to the 2 o'clock and 10 o'clock positions.
  • the non-penetrating rigid structures are supported by support structures 92.
  • the support structures are shaped to match portions of fornix-engaging structure 24.
  • fomix-engaging structure 24 may define guides 94 that are shaped to guide the support structures, and thereby guide the non-penetrating rigid structures into the 2 o'clock and 10 o'clock positions.
  • a guiding structure may be couplable to the fornix-engaging structure for guiding the nonpenetrating rigid structures into position, as described hereinabove.
  • a rigid-structure-insertion-rod 95 is used to insert nonpenetrating rigid structures 9OL and 9OR into the vaginal fornix.
  • a threaded portion 96 of non-penetrating rigid structures 9OL and 9OR may protrude from support structures 92.
  • rigid-structure-insertion-rod 95 is screwed onto threaded portion 96.
  • the rigid-structure-insertion-rod is used to push support structure 92 through guide 94, thereby placing the non-penetrating rigid structure in its intra-procedural position.
  • the rigid- structure-insertion-rod is unscrewed from threaded portion 96 of the non-penetrating rigid structure, and removed from the subject's body.
  • Figs. 17A-B are schematic illustrations of a locking mechanism 100, respectively, in unlocked and locked states, in accordance with some applications of the present invention.
  • locking mechanism 100 is in an unlocked state thereof, as shown in Fig. 17 A.
  • both of the non-penetrating rigid structures 9OL and 9OR are positioned within the vaginal fornix (e.g., at the 2 o'clock and 10 o'clock positions)
  • locking mechanism 100 is rotated in the direction of arrow 102, such that the locking mechanism locks support structures 92 into place, thereby locking nonpenetrating rigid structures 9OL and 9OR into place.
  • the locking procedure described above (or another procedure) is performed in order to lock non-penetrating rigid structures 9OL and 9OR.
  • locking mechanism 100 is used to maintain the position of non-penetrating rigid structures 9OL and 9OR inside the vaginal fornix, as described hereinabove.
  • locking mechanism 100 or a similar mechanism, is used to lock penetrating rigid structures 5 IL and 5 IR, described hereinabove, into position.
  • penetrating rigid structures 5 IL and 51R, and/or nonpenetrating rigid structures 9OL and 90R are locked into position with respect to fomix- engaging structure 24 (e.g., using locking mechanism 100), before being inserted into the subject's vagina.
  • the rigid structures are originally assembled in one integral piece with the fornix-engaging structure.
  • the fornix-engaging structure is inserted into the fornix with the rigid structures coupled thereto.
  • the fomix-engaging structure is locked with respect to positioning-anchoring tube 34, as described hereinabove.
  • Figs. 18A-G are schematic illustrations of nonpenetrating rigid structures 90, in accordance with respective applications of the present invention.
  • Figs. 18A-G are schematic illustrations of nonpenetrating rigid structures 90, in accordance with respective applications of the present invention.
  • one or more of the non-penetrating rigid structures shown in Figs. 18A-G are used, mutatis mutandis.
  • non-penetrating rigid structures are shown having given shapes in Figs. 15-16 and Figs. 18A-G, the scope of the present invention includes non-penetrating rigid structures having different shapes that would perform a similar function to the nonpenetrating rigid structures that are shown in the aforementioned figures.
  • the distal portions of the non-penetrating rigid structures shown in Figs. 15-16 and/or Figs. 18A-G are coated with a soft coating, in order to prevent the distal portions from penetrating tissue of the subject.
  • Figs. 18A- G The dimensions of the non-penetrating rigid structures that are shown in Figs. 18A- G are typically as follows:
  • Length L2 of non-penetrating rigid structures 9OL and 90R, shown in Fig. 18 A, is typically up to 80 mm.
  • the radius of curvature of curved distal portions 91 of each of the structures is typically 5 mm to 15 mm.
  • Length L2 of non-penetrating rigid structure 90 is typically up to 80 mm. It is noted that for some applications, as shown in Fig. 18B, a single rigid structure is used as both the left and right rigid structures. That is to say that a single rigid structure is placed anterior to both the subject's left and right broad ligaments.
  • the rigid structure typically defines an angle gamma, with respect to the longitudinal axis of fornix- engaging structure 24, of 70 degrees to 160 degrees. The angle gamma is the angle about the longitudinal axis that is encompassed by the angular extremities of rigid structure 90.
  • Length L2 of non-penetrating rigid structures 9OL and 9OR, shown in Fig. 18C, is typically up to 80 mm.
  • the radius of curvature of curved distal portions 91 of each of the structures is typically 5 mm to 15 mm.
  • Length L2 of non-penetrating rigid structure 90 is typically up to 80 mm.
  • the radius of curvature of curved distal portions 91 of the structure is typically 5 mm to 25 mm.
  • the rigid structure typically defines an angle gamma, with respect to the longitudinal axis of fornix-engaging structure 22, of 70 degrees to 160 degrees.
  • the angle gamma is the angle about the longitudinal axis that is encompassed by the angular extremities of rigid structure 90.
  • Length L2 of non-penetrating rigid structures 9OL and 90R, shown in Fig. 18E, is typically up to 80 mm.
  • Length L2 of non-penetrating rigid structure 90 is typically up to 80 mm.
  • the radius of curvature R of curved distal portions 91 of the structure is typically 5 mm to 25 mm.
  • the rigid structure typically defines an angle gamma, with respect to the longitudinal axis of fornix-engaging structure 22, of 70 degrees to 160 degrees.
  • the angle gamma is the angle about the longitudinal axis that is encompassed by the angular extremities of rigid structure 90.
  • Length L2 of non-penetrating rigid structure 90 is typically up to 80 mm.
  • the rigid structure typically defines an angle gamma, with respect to the longitudinal axis of fornix-engaging structure 22, of 70 degrees to 160 degrees.
  • the angle gamma is the angle about the longitudinal axis that is encompassed by the angular extremities of rigid structure 90.
  • Figs. 19-24 are schematic illustrations of respective steps of a procedure for occluding a subject's uterine arteries using device 20 (shown in an assembled configuration thereof in Fig. 24A, for example) that includes a two-portion fornix-engaging structure 110, in accordance with some applications of the present invention. It is noted that, for clarity, Figs. 19-24 show the steps of the procedure without showing the portions of the subject's anatomy with respect to which the procedure takes place.
  • Fornix-engaging structure 110 includes a first portion I IOA and a second portion HOB.
  • First and second portions HOA and HOB are inserted into the subject's fornix, in accordance with the techniques described hereinbelow, such that, in combination with one another, the first and second portions engage the vaginal fornix.
  • the two-portion fornix-engaging structure and techniques for use therewith are generally similar to fornix- engaging structure 24 and the techniques for use therewith described hereinabove, mutatis mutandis.
  • fornix-engaging structure 24 typically includes a single portion that engages the vaginal fornix.
  • first portion 11OA of the fomix-engaging structure is inserted into the subject's fornix (fornix not shown), through an incision, as described hereinbelow.
  • First portion I IOA of the fornix-engaging structure is typically coupled to insertion assembly 82, which is generally similar to insertion assembly 82, described with reference to Fig. 10.
  • left and right balloons 28L and 28R and cover 80 are disposed on the distal end of insertion assembly 82.
  • a different uterine artery compression device is disposed on the distal end of insertion assembly 82.
  • first portion 11OA of the fornix-engaging structure Prior to first portion 11OA of the fornix-engaging structure being inserted, an incision is made at approximately the 6 o'clock position in the vaginal fornix. Subsequently, insertion assembly 82 is inserted into the vaginal fornix, such that (a) balloons 28L and 28R pass through the incision into a position posterior to the subject's cervix, and (b) first portion 11OA of the fornix-engaging structure engages the posterior side of the vaginal fornix.
  • positioning-anchoring balloon 32 is inserted into the subject's uterus and inflated. Positioning-anchoring balloon 32 is disposed at the distal end of positioning- anchoring tube 34. Positioning-anchoring balloon 32 and positioning-anchoring tube 34 are generally as described hereinabove.
  • the positioning-anchoring balloon is typically inserted into the subject's uterus via second portion 11OB of the fornix-engaging structure, prior to second portion 11OB engaging the fornix. Further subsequently, portion 11OB of the fornix-engaging structure is advanced over positioning-anchoring tube 34, into contact with the vaginal fornix (shown in Figs. 20 and 21, without the fornix).
  • Portions 11OA and HOB become coupled to each other, as shown in Fig. 21, inside the vaginal fornix (fornix not shown).
  • the position of the fornix cap is typically locked with respect to positioning-anchoring tube 34, e.g., in accordance with the techniques described herein.
  • Fig. 22 shows device 20 at this stage.
  • Fig. 22 shows rigid structures 5 IL and 5 IR, which pass through incisions in the subject's vaginal tissue, for some applications, non-penetrating rigid structures are inserted into the approximately 2 o'clock and 10 o'clock positions in the vaginal fornix.
  • non-penetrating rigid structures 9OL and 9OR described hereinabove, may be used, using generally similar techniques to those described hereinabove.
  • cover 80 is withdrawn from balloons 28L and 28R. This step is generally similar to the cover-withdrawal step described with reference to Fig. 12.
  • balloons 28L and 28R are (a) lifted anteriorly and separated sideways from one another, using a technique that is generally similar to that described with reference to Figs. 13A-B, and (b) inflated such that the balloons press the left and right broad ligaments against rigid structures 5 IL and 5 IR (or non-penetrating rigid structures 9OL and 90R).
  • Fig. 24B shows a posterior-cephalic view of the fornix-engaging structure, in which the coupling of first and second portions HOA and HOB of the fornix-engaging structure may be observed.
  • the first and second portions are typically coupled to each other inside the vaginal fornix.
  • Fig. 25 is a schematic illustration of device 20 including a three-portion fornix-engaging structure 120, in accordance with some applications of the present invention.
  • First, second, and third portions 120A, 120B, and 120C are inserted toward the subject's fornix, in accordance with the techniques described hereinbelow, such that, in combination with one another, the first, second, and third portions engage the vaginal fornix.
  • the three-portion fornix-engaging structure and techniques for use therewith are generally similar to fornix-engaging structure 24 and the techniques for use therewith described hereinabove, mutatis mutandis.
  • fornix- engaging structure 24 typically includes a single portion that engages the vaginal fornix.
  • fornix-engaging structure 110 typically includes two portions that engage the vaginal fornix.
  • positioning-anchoring tube 34 and positioning-anchoring balloon 32 are inserted via first portion 120A of fornix-engaging structure 120.
  • Left and right balloons 28L and 28R are coupled to second portion 120B of fornix-engaging structure 120.
  • Second portion 120B is inserted into the fornix using insertion assembly 82, as described hereinbelow.
  • Rigid structures e.g., penetrating rigid-structures 51L and 51R
  • third portion of the fornix-engaging structure is typically inserted into the fornix using decouplable insertion rods 122.
  • the third portion of the fornix-engaging structure typically comprises left and right support elements 124L and 124R that support rigid structures 5 IL and 5 IR.
  • Fig. 25 shows rigid structures 5 IL and 5 IR that are shaped in shapes similar to non-penetrating rigid structures 9OL and 9OR (described hereinabove), in the technique described hereinbelow, rigid structures 5 IL and 5 IR do pass through an incision made in vaginal tissue into the paracervical space.
  • the scope of the present invention includes using non-penetrating rigid structures 90 for the technique described with reference to Figs. 26-39, and/or using penetrating rigid structures 51 that have shapes that are generally similar to those shown in Figs. 3A-F, mutatis mutandis.
  • Figs. 26-39 are schematic illustrations of respective steps of a procedure that is used with three-portion fornix-engaging structure 120, in accordance with some applications of the present invention.
  • the procedure typically includes one or more of the following steps: (1) Bed-side system 10 (shown in Fig. 1) is prepared for the procedure.
  • the bedside system typically includes control unit 52, which typically controls inflation of balloons of device 20.
  • the bed-side system includes a monitor (not shown) that displays the readings of sensors of the system (e.g., pressure sensors 48, microphones 46, and/or oximeters 40, described hereinabove).
  • the preparation of the bed-side system may include the step of connecting sensors of the system (e.g., pressure sensors 48, microphones 46, and/or oximeters 40, as described hereinabove) to control unit 52 of the bed-side system, typically via cables.
  • the preparation of the bed-side system may include the step of connecting inflation tubes of balloons of the system to a pressure-generating system, the pressure-generating system typically being under the control of control unit 52, and/or a healthcare provider.
  • the subject's cervical width may be determined using either abdominal or transvaginal ultrasound.
  • dimensions of the rigid structures e.g., penetrating rigid structures 51, and/or non-penetrating rigid structures 90
  • dimensions of the subject's fornix are measured, e.g., using a transvaginal sonogram.
  • dimensions of the fornix-engaging structure that is used during the procedure are selected based upon the measured dimensions of the subject's fornix.
  • FIG. 26 is a schematic illustration of a portion of the subject's fornix 45, an anterior colpotomy having been performed on the subject's fornix.
  • Rigid structures are inserted into the paracervical space, via the anterior colpotomy.
  • the rigid structures are temporarily inserted into the paracervical space at this stage (a) in order to develop and create paracervical space, and/or (b) in order to determine suitable dimensions of the rigid structures.
  • a first one of the rigid structures e.g. right rigid structure 51R, as shown
  • a second one of the rigid structures e.g. left rigid structure 51L
  • Left and right support elements 124L and 124R are then coupled to each other, as shown in Fig. 29.
  • the rigid structures are removed from the paracervical space using insertion rods 122.
  • a posterior colpotomy i.e., an incision at approximately the 6 o'clock position
  • the posterior colpotomy site is identified by identifying the insertion of the uterosacral ligaments into the posterior aspect of the cervix. Responsive to the identification, an incision is made (e.g., using mayo scissors), thereby providing access to the peritoneal cavity.
  • Balloons 28L and 28R are inserted through the posterior colpotomy, as shown in Fig. 31.
  • the balloons are typically positioned at the cul-de-sac, at the level of the uterosacral ligament insertion into the cervix, while the balloons are in a deflated, folded configuration, inside cover 80.
  • the orientation of the balloons with respect to the subject's anatomy is typically adjusted at a later stage of the procedure, due to the insertion of first portion 120A of the fornix-engaging structure, and the coupling of first portion 120A with second portion 120B of the fornix-engaging structure.
  • portion 120A of fornix-engaging structure 120 is placed over positioning-anchoring tube 34, as shown in Fig. 32.
  • the aforementioned step is performed while portion 120A and positioning-anchoring balloon 32 are outside the subject's body.
  • portion 120A is slid proximally along the positioning-anchoring rod.
  • portion 120A may be slid to (or beyond) proximal end 126 of positioning-anchoring tube 34, for vaginal positioning at a later stage.
  • the length of the subject's uterus and cervical canal is determined, e.g., via ultrasound, or via sound.
  • Positioning-anchoring tube 34 is inserted into the cervix (e.g., using a tenaculum), as shown in Fig. 33. It is noted that, as shown in Fig. 33, for some applications, a diameter Dl of a distal portion of positioning-anchoring tube 34 is less than a diameter D2 of a proximal portion of the positioning-anchoring tube. Similarly, the diameter of positioning-anchoring balloon 32, when positioning-anchoring balloon 32 is in a folded state thereof (as shown in Fig. 33), during insertion of the balloon through portion 120A of the fornix-engaging structure, is less than diameter D2 of the proximal portion of the positioning-anchoring tube.
  • a balloon that is similar to the silicone balloon of The Rumi System® is used as the intrauterine balloon.
  • the narrower diameter Dl of the distal portion of the tube 34 and of the balloon 32 facilitates insertion of the distal portion of the positioning-anchoring tube and the balloon through the subject's cervical canal.
  • the wider diameter D2 of the proximal portion of tube 34 facilitates accommodation of wiring and tubing by the proximal portion of the tube, and/or facilitates locking the proximal portion of the tube (e.g., via a clamp 154, shown in Fig. 42A) to portion 120A.
  • diameter Dl of the distal portion of tube 34 is more than 3 mm and/or less than 5 mm, e.g., 3-5 mm.
  • the diameter of positioning-anchoring balloon 32, when positioning-anchoring balloon 32 is in a folded state thereof, during insertion of the balloon through portion 120A of the fomix-engaging structure is more than 3 mm and/or less than 8 mm, e.g., 3-8 mm.
  • diameter D2 of the proximal portion of tube 34 is more than 4 mm, and/or less than 10 mm, e.g., 4-10 mm.
  • positioning-anchoring balloon 32 is inflated, as shown in Fig. 34.
  • the balloon is inflated to more than 200 mmHg, and/or less than
  • the balloon is positioned in contact with the lower uterine segment, by pulling the positioning-anchoring tube 34 retrograde.
  • Rigid structures 51L and 51R are inserted into the paracervical space via the anterior colpotomy, using insertion rods 122, as shown in Figs. 35 and 36. Left and right support elements 124L and 124R are then coupled to each other. For some applications, insertion rods are subsequently decoupled from the support elements and removed from the subject's body. Alternatively, the insertion rods remain coupled to the support elements until the support elements are removed from the subject's body.
  • both left and right rigid structures 51 are inserted via a single vaginal incision at the 12 o'clock position.
  • incisions are made at approximately the 2 o'clock and 10 o'clock positions of the vaginal fornix, and the left and right rigid structures are inserted via respective, separate incisions.
  • inserting both of the rigid structures via a single incision facilitates the creation of paracervical space above the cervix and the targeted arteries, with less risk to the arteries in the vicinity and/or to the ureters, relative to if the rigid structures are inserted via more than one incision. For some applications, this is because by making only one incision, the paracervical space may be created without the arteries and/or the ureters being repositioned.
  • a blunt tool, and or a person's fingers are used to create the paracervical space.
  • a blunt tool and/or a person's fingers the risk of puncturing the subject's bladder, and/or damaging blood vessels of the subject is reduced, relative to if a sharp tool is used to create the paracervical space.
  • First portion 120A of the fornix-engaging structure is inserted into the subject's fornix.
  • the first portion is slid distally along the positioning-anchoring tube to the subject's fornix.
  • first portion 120A of the fornix-engaging structure is coupled to (a) second portion 120B and (b) third portion 120C of the fornix-engaging structure, as shown in Fig. 37.
  • positioning-anchoring tube 34 is pulled slightly retrograde, (b) fornix-engaging structure 120 is pushed such that the structure engages the fornix, and then (c) the position of the fornix-engaging structure with respect to the positioning-anchoring tube is locked, using a locking mechanism (e.g., a clamp, as described hereinbelow).
  • a locking mechanism e.g., a clamp, as described hereinbelow.
  • monitoring of the sensor readings e.g., readings of pressure sensors 48, microphones 46, and/or oximeters 40, as described hereinabove.
  • Cover 80 is removed from balloons 28L and 28R, e.g., by pulling string 140 (shown in Fig. 37), as described hereinbelow.
  • the balloons are lifted anteriorly and are separated from each other by being moved respectively to left and right sides of the cervix (e.g., in accordance with the techniques described hereinabove), as shown in Fig. 38.
  • Balloons 28L and 28R are inflated, in accordance with the techniques described hereinabove, as shown in Fig. 39.
  • the balloons are inflated to a pressure of more than 80 mmHg, and/or less than 300 mmHg, e.g., to 80-300 mmHg.
  • the pressure of the balloons is typically displayed on a monitor of bed-side system 10.
  • the output unit typically displays the following data, which are determined using the sensors described hereinabove: (a) Pressure within balloons 28L and 28R, and pressure within positioning- anchoring balloon 32.
  • the displayed data are typically monitored during the procedure.
  • a healthcare professional, and/or control unit 52 modulates the pressure in balloons 28L, 28R, 55L, 55R, and/or 32.
  • balloons 28L and 28R are deflated, e.g., by opening stop cocks that are disposed in tubing that provides fluid communication between the balloons and the pressure-generating system.
  • the apparatus is then typically removed from the subject's body in one or more of the following steps:
  • Balloons 28L and 28R are folded and brought together, e.g., by turning knob 86, described hereinabove with reference to Fig. 13B.
  • First portion 120A of the fornix-engaging structure is removed by unlocking the fomix-engaging structure from the positioning-anchoring tube, decoupling the first portion of the fornix-engaging structure from the second and third portions of the fornix-engaging structure, and pulling the first portion out of the subject's vagina.
  • Balloons 28L and 28R are removed from the subject's body, using insertion assembly 82.
  • Positioning-anchoring balloon 32 is deflated (e.g., using a stop cock that is disposed in tubing that provides fluid communication between the balloon and the pressure-generating system). Subsequently, positioning-anchoring tube 34 is removed from the subject's body. It is noted that, for some applications, not all of the procedure steps described with reference to Figs. 26-39 are performed. It is further noted that the procedure steps described with reference to Figs. 26-39 may be performed in an order different from that described hereinabove. It is still further noted that a generally similar procedure to that described with reference to Figs. 26-29 may be performed using single portion fornix- engaging structure 24 or two-portion fornix-engaging structure 110, mutatis mutandis.
  • Figs. 40A-F are schematic illustrations of respective views of decouplable support elements 124L and 124R of non-penetrating rigid structures 5 IL and 5 IR, in accordance with some applications of the present invention.
  • support elements 124L and 124R When coupled to each other, as shown in Fig. 4OA, support elements 124L and 124R comprise third portion 120C of the three-portion fornix-engaging structure, described hereinabove with reference to Fig. 25.
  • the support elements are decouplable from one another.
  • Insertion rods 122 are used to insert support elements 124L and 124R into the subject's fornix (and through the anterior incision in the fornix) and to remove the support elements from the subject's fornix.
  • the insertion rods are typically decouplable from the support elements (e.g., via threading 131), as shown in Fig. 4OC.
  • left and right support elements 124L and 124R become coupled to each other (typically once they have passed through the anterior incision in the fornix) by a protrusion 130 on one of the support elements being inserted into a groove 132 on the other support element.
  • Protrusion 130 is typically inserted into groove 132 by rotating one of the support elements with respect to the other support element on a hinge 134, as shown in Fig. 4OF.
  • protrusion 130 When protrusion 130 is inserted inside groove 132, the support elements become held in place with respect to one another, for example, via a second protrusion 136 and a second groove 138, as shown in Fig. 4OG.
  • the described coupling configuration is by way of illustration and not limitation. Alternative configurations include protrusions, grooves, or other coupling mechanisms being located at other locations with respect to left and right support elements 124L and 124R.
  • Figs. 41A-G are schematic illustrations of respective views of left and right balloons 28L and 28R that are used as at least a portion of a uterine artery compression device, in accordance with some applications of the present invention.
  • the balloons are disposed inside cover 80, as shown in Fig. 4 IA.
  • the cover is removed from the balloons by pulling a thread 140, which causes the cover to open, as shown in Fig. 4 IB.
  • the balloons are separated from one another and moved anteriorly, as described hereinabove.
  • the balloons are separated from one another and moved anteriorly by rotating knob 86 in a given direction, as shown in Fig.
  • knob 86 is rotated in the direction opposite to the given direction.
  • the balloons are typically connected to one another via at least one flexible connecting member 74.
  • two or more connecting members connect the balloons.
  • the connecting members are longer than the distance between balloons 28L and 28R, even when the balloons are separated from one another.
  • a rigid central rod 142 flexes the connecting members (Fig. 41C), causing the connecting members to maintain the balloons generally in the desired configuration shown in Fig. 41C, prior to inflation of the balloons.
  • rod 142 is coupled to the connecting members, for example, by an adhesive or via an additional portion (not shown) placed over rod 142.
  • Fig. 4 ID shows an end-view of the balloons in deflated states thereof, when the balloons have been lifted anteriorly and separated from one another.
  • Figs. 41E-G Respective views of the inflated balloons are shown in Figs. 41E-G.
  • Figs. 42A-B are schematic illustrations of a first portion 120A of three-portion fornix-engaging structure 120, in accordance with some applications of the present invention.
  • First portion 120A defines a posterior slot 150, into which second portion 120B of the fornix-engaging structure is inserted.
  • First portion 120A additionally defines an anterior slot 152, into which third portion 120C of the fornix- engaging structure is inserted.
  • portion 120A includes a clamp 154 at a proximal end thereof for locking positioning-anchoring tube 34 (not shown) with respect to portion 120A, in accordance with the techniques described hereinabove.
  • Figs. 43A-C are schematic illustrations of three- portion fornix-engaging structure 120, in accordance with some applications of the present invention.
  • second portion 120B of the fornix-engaging structure is inserted into posterior slot 150 defined by first portion 120A of the fornix-engaging structure.
  • the insertion of second portion 120B into posterior slot 150 typically couples second portion 120B to first portion 120A, such that the second portion is prevented from rotating with respect to the first portion.
  • a protrusion 156 from second portion 120B of the fornix-engaging structure prevents the second portion from sliding distally with respect to first portion 120A by the protrusion engaging with the first portion.
  • protrusion 156 engages the first portion due to a downward force Fl that is applied to the second portion, causing the proximal end of the second portion to tilt upward.
  • Force Fl is typically applied to the second portion during the procedure.
  • the second portion of the fornix- engaging structure is able to slide distally with respect to the first portion.
  • third portion 120C of the fornix-engaging structure is inserted into anterior slot 152 defined by first portion 120A of the fornix-engaging structure.
  • the insertion of second portion 120B into anterior slot 152 typically couples third portion 120C to first portion 120A, such that the third portion is prevented from rotating with respect to the first portion.
  • a protrusion 158 from third portion 120C of the fornix-engaging structure prevents the third portion from sliding distally with respect to first portion 120A by the protrusion engaging with the first portion.
  • protrusion 158 engages the first portion due to an upward force F2 that is applied to the third portion, causing the proximal end of the third portion to tilt downward. Force F2 is typically applied to the third portion during the procedure.
  • the third portion of the fornix- engaging structure is able to slide distally with respect to the first portion.
  • Figs. 44A-B are schematic illustrations of a device 20 for occluding uterine arteries, including one or more double-chambered balloons
  • Device 20 shown in Figs. 44A-B is generally similar to the devices described hereinabove for occluding a subject's uterine arteries, except that the device includes double-chambered balloons 160 serving as left and right balloons 28L and 28R.
  • balloons 160 are shown being used with three-portion fornix-engaging structure 120, the scope of the invention includes using balloons 160 with any of the fomix-engaging structures described herein.
  • using double-chambered balloons 160 facilitates expansion of the balloons in a desired direction during inflation of the balloons.
  • Figs. 45A-D are schematic illustrations of double-chambered balloon 160, in accordance with some applications of the present invention.
  • Figs. 45A-C show respective views of a single double-chambered balloon, while the double-chambered balloon is in an inflated state thereof.
  • first and second chambers 162 and 164 of the double- chambered balloon are folded with respect to each other, and are held in the folded configuration with respect to one another via a connecting element 166.
  • the first and second chambers are in fluid communication with one another via a tube 168.
  • the first and second chambers are not in fluid communication with one another, and the chambers are inflated via separate inflation tubes.
  • Fig. 45D shows left and right double-chambered balloons 160L and 160R in uninflated, unfolded states. As described hereinabove, the left and right balloons are coupled to one another by one or more connecting members 74.
  • Figs. 46A-C are schematic illustrations of left and right double-chambered balloons 170L and 170R, in accordance with some applications of the present invention.
  • Double-chambered balloons 170L and 170R typically serve as left and right balloons 28L and 28R, in accordance with the techniques described hereinabove.
  • first and second chambers 172 and 174 of each of the double-chambered balloons are coupled to one another at the centers of the chambers.
  • the first and second chambers of each of the balloons are in fluid communication with one another and are inflated via a single inflation tube.
  • the first and second chambers are not in fluid communication with one another, and the chambers are inflated via separate inflation tubes.
  • each of the chambers includes a connecting element 176.
  • the connecting elements of each of the chambers of a balloon are connected to one another during inflation of the balloon, in order to prevent the chambers from rotating with respect to one another.
  • portions of a device e.g. rigid structures 51
  • portions of a device e.g. rigid structures 51
  • such descriptions include within their scope, the placement of the portions of the device anterior to a perivascular adipose layer of the subject's broad ligament, but, for example, posterior to the anterior-most mucosal layer of the subject's broad ligament.
  • a balloon as a uterine artery compression device
  • the scope of the present invention includes using other devices (e.g., solid or flexible devices) for occluding the uterine artery instead of or in addition to a balloon, mutatis mutandis.
  • a device that is configured to expand toward the subject's broad ligaments via an expansion mechanism, such as via a spring-mechanism may be used as a uterine artery compression device.
  • the apparatus and techniques described herein are used in combination with apparatus and techniques described in (a) US 2009/0093758 to Gross (b) US 2009/0318950 to Gross, (c) US Patent Application 12/509,732 to Gross, and/or (d) US 61/300,262 to Gross, all of which applications are incorporated herein by reference.

Abstract

La présente invention concerne un appareil et des procédés destinés à être utilisés avec un corps, un vagin (27), un fornix vaginal (45), un utérus (23), un col de l'utérus (35), des ligaments larges gauche et droit (53) et des artères utérines gauche et droite (21) d'un sujet. Ledit appareil comprend des structures rigides gauche et droite (51L, 51R) qui sont insérées dans le fornix du sujet, de sorte que des extrémités distales des structures rigides se situent sur des sites antérieurs aux couches adipeuses périvasculaires des ligaments larges gauche et droit du sujet respectivement. Au moins un dispositif de compression d'artère utérine (28L, 28R) est placé postérieurement aux ligaments larges ; il comprime les artères utérines gauche et droite du sujet en pressant les ligaments larges gauche et droit respectivement contre les structures rigides gauche et droite. L'invention porte en outre sur d'autres modes de réalisation.
PCT/IL2010/000610 2009-07-27 2010-07-27 Structures d'occlusion de l'artère utérine WO2011013127A2 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP10804003A EP2459080A2 (fr) 2009-07-27 2010-07-27 Structures d'occlusion de l'artère utérine
US13/352,894 US20120136369A1 (en) 2009-07-27 2012-01-18 Structures for occluding the uterine artery

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US12/509,732 US8403953B2 (en) 2009-07-27 2009-07-27 Balloon with rigid tube for occluding the uterine artery
US12/509,732 2009-07-27
US30026210P 2010-02-01 2010-02-01
US61/300,262 2010-02-01

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
US12/509,732 Continuation-In-Part US8403953B2 (en) 2009-07-27 2009-07-27 Balloon with rigid tube for occluding the uterine artery

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US13/352,894 Continuation-In-Part US20120136369A1 (en) 2009-07-27 2012-01-18 Structures for occluding the uterine artery

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US20050187561A1 (en) * 2004-02-25 2005-08-25 Femasys, Inc. Methods and devices for conduit occlusion
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US20050187561A1 (en) * 2004-02-25 2005-08-25 Femasys, Inc. Methods and devices for conduit occlusion
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