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EP0989822A1 - Procedes et dispositifs d'hemostase acoustique - Google Patents

Procedes et dispositifs d'hemostase acoustique

Info

Publication number
EP0989822A1
EP0989822A1 EP97941317A EP97941317A EP0989822A1 EP 0989822 A1 EP0989822 A1 EP 0989822A1 EP 97941317 A EP97941317 A EP 97941317A EP 97941317 A EP97941317 A EP 97941317A EP 0989822 A1 EP0989822 A1 EP 0989822A1
Authority
EP
European Patent Office
Prior art keywords
site
radiating surface
hemostasis
imaging
remote
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
EP97941317A
Other languages
German (de)
English (en)
Other versions
EP0989822A4 (fr
Inventor
Edward C. Driscoll, Jr.
Lawrence A. Crum
Wing K. Law
Stan Demarta
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Focus Surgery Inc
Original Assignee
Focus Surgery 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
Application filed by Focus Surgery Inc filed Critical Focus Surgery Inc
Publication of EP0989822A1 publication Critical patent/EP0989822A1/fr
Publication of EP0989822A4 publication Critical patent/EP0989822A4/fr
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N7/02—Localised ultrasound hyperthermia
    • A61N7/022—Localised ultrasound hyperthermia intracavitary
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00106—Sensing or detecting at the treatment site ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491—Surgical glue applicators
    • A61B2017/00504—Tissue welding
    • 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
    • A61B2017/12004—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for haemostasis, for prevention of bleeding

Definitions

  • the present invention relates generally to the remote application of therapeutic radiated energy.
  • the present invention provides a method for applying high intensity focused ultrasound to reduce internal bleeding.
  • Ultrasound imaging generally relies on differences in the reflection of high frequency acoustic waves by organ and soft tissues. Ultrasound waves, when applied at power levels required for imaging, have been found to be free from the deleterious side effects associated with many other forms of radiated energy, such as X-rays, microwaves, and other electromagnetic fields. Hence, ultrasound imaging systems have a distinct safety advantage over other known imaging modalities.
  • Imaging ultrasound waves are radiated from a transducer which also senses the reflections.
  • Imaging ultrasound transducers often make use of multiple radiating and/or receiving surfaces.
  • modern ultrasound probes often use precise timing control over a series of active surface regions, referred to as a phased array, to control the radiation direction and to sense the source of reflections.
  • Ultrasound imaging systems having multiple transducer surface regions have found particular use in Doppler measurements of internal blood flows.
  • Ultrasound Doppler imaging systems make use of multiple ultrasound pulses to non-invasively monitor internal movements. Doppler imaging typically relies on the frequency shift of acoustic reflections from moving matter, and also on the change in position of discrete masses between pulses.
  • Doppler colorflow imaging indicates relative speeds of motion by assigning a range of false colors for the measured speeds.
  • Ultrasound Doppler systems may scan a single sector of tissue, or may scan in multiple orientations to provide three-dimensional imaging.
  • Array transducers facilitate Doppler imaging by providing electronic scanning through control of the phase of excitation provided to the discrete regions of the array.
  • ultrasound imaging is noted for its safety, ultrasound energy applied at higher power densities can have significant physiological effects on tissues. These physiological effects may result from either thermal or mechanical effects of ultrasound energy.
  • Thermal effects of ultrasound include localized heating, hyperthermia, and ablation of tissue (with relatively low energy levels), and even rapid high temperature searing.
  • Mechanical effects include breaking-up of solid objects, liquefaction of tissues, and cavitation.
  • HIFU high intensity focused ultrasound
  • Focal diseases for which HIFU has been suggested include, for example, neoplastic and other diseases of or in the brain, breast, liver, and prostate.
  • HIFU therapy potentially offers a non-invasive or minimally invasive alternative, thereby inflicting much less trauma on the patient, and promoting faster healing.
  • HIFU therapy is now available as a treatment for benign prostatic hyperplasia (herein sometimes referred to as "BPH"), allowing the remote ablation of hyperplastic tissue without physical penetration of the urethra and prostate, thus reducing the risk of infection.
  • BPH benign prostatic hyperplasia
  • Transducer Probe System And Methods For Its Use describes an exemplary HIFU system and method for the treatment of BPH and other focal diseases.
  • This exemplary HIFU system includes a probe housing containing a multifaceted therapeutic transducer member and a servo system for aiming the transducer member within the probe.
  • the transducer member has a plurality of radiating surfaces having different focal lengths and different radial orientations. Power is transmitted to alternative radiating surfaces to select a target depth. Additionally, an independent inner region of each radiating surface allows further variation in the target depth by manipulating the inner region's power supply phase relative to the surrounding outer region, the inner and outer regions acting as a simple phased array.
  • An imaging transducer is also carried on the transducer member, allowing a single servo system to select the focal depth, aim the therapeutic surface, and scan the imaging transducer.
  • HIFU treatments have generally relied only on the thermal and mechanical effects of ultrasound energy on fixed tissues and structures.
  • the potential application of therapeutic ultrasound energy on body fluids, particularly for the coagulation of blood to control internal bleeding, has not previously been explored.
  • DPL diagnostic peritoneal lavage
  • U.S. Patent No. 5,322,055 describes an ultrasonic clamp which coagulates tissues within a scissor-like jaw as it cuts.
  • U.S. Patent No. 5,013,312 describes an ultrasonic scalpel having an integral bipolar electrode to coagulate as it cuts.
  • U.S. Patent No. 5,207,672 describes the use of laser energy to cause coagulative necrosis of compressed prostatic tissue.
  • U.S. Patent No. 5,269,778 describes the use of a variable pulse width laser to penetrate tissue and effect deep coagulation.
  • U.S. Patent No. 5,052,395 describes an ultrasonic pulse Doppler cardiac monitor which measures blood velocity.
  • U.S. Patent No. 5, 152,294 describes a three-dimensional ultrasonic scanner.
  • U.S. Patent No. 5, 186,175 describes a two-dimensional ultrasonic diagnostic array.
  • U.S. Patent Nos. 5,379,642; ,5,255,682; 4,945,915; 4,155,260; and 5,050,588 are generally relevant.
  • the present invention provides the remote coagulation of blood using high- intensity focused ultrasound (HIFU).
  • HIFU high- intensity focused ultrasound
  • the present invention provides methods and devices for identifying a site of internal bleeding, and focusing therapeutic ultrasound energy through an intervening tissue and onto the bleeding site, so as to remotely provide hemostasis.
  • Such systems and methods promote the diagnosis and stabilization of trauma victims suffering hemoperitoneum. without resorting to invasive surgical procedures.
  • remote hemostasis of the present method may be used as a complete therapy, or may alternatively be used to buy time for the patient to reach and receive conventional treatment in a critical care facility.
  • the method of the present invention comprises identifying a site of internal bleeding, and focusing therapeutic ultrasound energy on the site. The energy is transmitted from a radiating surface and passes through an intervening tissue. The focused energy coagulates blood adjacent to the internal bleeding site, thereby providing hemostasis.
  • hemostasis is defined as a temporary or permanent reduction or cessation of the release of blood from the circulatory system, tissues, and organ
  • the identifying step comprises Doppler imaging a section of the patient body with a pulsed ultrasound transducer, typically using colorflow imaging techniques.
  • the identifying step preferably comprises elasticity imaging.
  • elasticity imaging is performed by locally displacing tissue and monitoring the tissue displacement. Elasticity imaging is particularly well-suited for the identification of stiff coagulated regions and unconstrained liquids such as freestanding blood.
  • a contrast agent may be introduced into the blood stream and an X- ray or ultrasound angiogram made to identify the internal bleeding site.
  • identification relies on sensing and isolating the acoustic or other vibrational signature of a vascular breach.
  • the present invention provides a method comprising identifying a site of internal bleeding, targeting a region adjacent to the site for therapy, and focusing therapeutic ultrasound energy on a target within the therapy region. The ultrasound energy is again emitted from a radiating surface, and passes through an intervening tissue on its way to the target. Generally, an appropriate target depth is also selected.
  • the radiating surface and an ultrasound imaging transducer array are carried within a single housing, allowing the device to be easily aimed towards the internal bleeding site by moving the housing over the patient's skin in a "point-and-shoot" mode.
  • the focusing step of the method of the present invention generally comprises coagulating blood at. the target.
  • coagulation is apparently the result of at least three separate mechanisms.
  • heating has been observed to cause thrombosis, even at relatively low levels above body temperature.
  • mechanical streaming of blood caused by the ultrasound energy, and the impact of that blood with vessel walls and other obstructions has been observed to cause the production of thrombi.
  • HIFU typically produces cavitation in the focal zone.
  • hemostasis is provided by coagulating blood so as to form a plug within the vessel.
  • the therapy volume extends upstream of the vascular breach along the blood vessel, so that the plug occludes the vessel and reduces the release of blood.
  • hemostasis may be achieved by cauterizing tissue, particularly by selecting a therapy region which encompasses an organ fracture.
  • the ultrasound energy may be used to weld tissues at the target, analogous to the ultrasonic cauterization of vessels produced by mechanical ultrasonic clamps.
  • the present invention provides a method for producing remote hemostasis comprising identifying a site of internal bleeding, and introducing an ultrasound hemostasis enhancement agent to the site.
  • Therapeutic ultrasound energy is then focused from a radiating surface to activate the hemostasis agent adjacent to the site, the energy passing through an intervening tissue.
  • the hemostasis agent foams under ultrasound energy, so as to occlude a vascular breach.
  • Suitable foaming hemostasis agents includes perfluorocarbons, particularly those having boiling temperatures between 40°C and 80°C.
  • the hemostasis agent comprises an encapsulated thrombus- producing agent, typically being an element from the clotting cascade. The use of such hemostasis agents will be particularly advantageous for providing remote hemostasis to vascular breaches of major vessels, for example, in stabilizing a ruptured abdominal aneurysm without occluding the aorta.
  • An apparatus for producing remote hemostasis comprises a radiating surface for applying focused therapeutic ultrasound energy on a remote target, and a sensor for identifying a site of internal bleeding.
  • a registration means is coupled to the radiating surface and the sensor to align the target and the internal bleeding site. Therapy for internal bleeding is thereby provided without the need for invasive surgical procedures, even at remote locations where surgical facilities are not available.
  • a focusing mechanism is provided to allow variations in therapy depth.
  • focusing means adjustments to the effective focal length of a radiating surface to vary the distance between the radiating surface and the target.
  • the radiating surface is formed as a phased array, and the focusing mechanism comprises a phase controller.
  • a phased array comprising an annular array is particularly preferred, allowing simple and accurate variations in focal depths with a minimum amount of circuit complexity.
  • the registration means comprises a mechanical linkage between the radiating surface and the sensor.
  • the radiating surface and sensor may be affixed to a common structure to facilitate registration of the target. Nonetheless, one or more degrees of freedom are often provided between the sensor and radiating surface, for example, the variable therapy depth of a phased annular array radiating surface, or the linear and sector scan servo mechanisms which alter the radiating surface orientation after an imaging scan and before therapy is applied.
  • the registration means comprises a position indication system coupled to the radiating surface and the sensor. Where the position indication system comprises a global positioning system providing the complete position and orientation of the radiating surface, the target may be registered to the site despite the lack of any mechanical linkage.
  • a 3-D model of a portion of the patient body is assembled from the imaging data supplied to a processor by the sensor, and the target is then electronically registered to the 3-D model using data provided by the position indication system.
  • an apparatus for producing remote hemostasis comprises a pulsed ultrasound imaging transducer and an ultrasound radiating surface which focuses therapeutic energy at a target.
  • a display is coupled to both the imaging transducer and to the radiating surface, so that the display indicates a relative position of the target and an internal bleeding site.
  • the radiating surface comprises a phased array to provide a variable therapy depth, while the display generally indicates any difference between the selected depth and the depth of the site.
  • a structure carries the transducer and the radiating surface. A translation of the structure relative to the site results in a repositioning of the site relative to the target on the display.
  • Such a structure typically comprising a housing, allows at least rough locating of the internal bleeding site by relocating or sliding the housing over the patient's skin.
  • precise positioning is provided by a servo mechanism supporting the radiating surface from the housing structure, or by electronic manipulation of the phased array.
  • the remote hemostasis apparatus may be used as a "point-and-shoot" device, being aimed toward the target location by hand, focused to the target depth by manipulation of an annular array, and manually activated.
  • Such a "point- and-shoot" device would be particularly advantageous for emergency medical personnel, including both civilian paramedics and military field medics.
  • the display will provide a Doppler colorflow image, facilitating the identification of internal bleeding.
  • a tissue displacement mechanism is coupled to the imaging transducer, allowing the display to provide an elasticity image as described above.
  • Doppler colorflow images and elasticity images will also facilitate the identification and mapping of coagulated and cauterized regions, thereby enhancing the therapy zone management of the apparatus.
  • a coagulation memory is coupled to the radiating surface and the display so that the display electronically indicates coagulated regions.
  • Fig. 1 illustrates a high-intensity focused ultrasound (HIFU) remote hemostasis apparatus according to the principles of the present invention
  • Fig. 2 illustrates a HIFU probe for use with the remote hemostasis apparatus of Fig. 1;
  • Fig. 3 is a cross-section of the HIFU probe of Fig. 2;
  • Fig. 4 is a cross-section of the distal end of the HIFU probe of Fig. 3, showing a membrane pressurization system which acts as a local tissue displacement mechanism for elasticity imaging;
  • Fig. 5 illustrates a control diagram for the remote hemostasis apparatus of Fig. 1;
  • Fig. 6 illustrates a therapy zone appropriate for providing hemostasis of an organ fracture using the remote hemostasis apparatus of Fig. 1;
  • Figs. 7A-C illustrate a self-contained point-and-shoot remote hemostasis apparatus according to the principles of the present invention.
  • the present invention provides a high-intensity focused ultrasound (HIFU) system and methods for its use to provide remote hemostasis.
  • HIFU apparatus of the present invention will find a wide range of applications for the identification and targeting of internal bleeding.
  • the present invention will have particular applications for aneurysms and other diseases of the vascular system.
  • the apparatus and methods of the present invention will find further use in establishing hemostasis after an invasive surgery surgical procedure.
  • hemostasis and cauterization provided by the present invention may be used to deny a supply of blood to certain diseased tissues, particularly tissues having hyperplastic diseases.
  • the present remote hemostasis apparatus and methods may be applied laparoscopically, using an intraluminal probe, minimally invasively, using an intracavity probe, or noninvasively, using an extracorporal probe. Although such systems and methods will thus have a wide range of applications, the present invention will find its greatest applications in the stabilization of the victims of blunt trauma, either prior to conventional invasive procedures, or instead of such procedures.
  • the methods and apparatus of the present invention are particularly well-suited for medical and emergency personnel who do not have immediate access to extensive critical care health facilities.
  • the remote hemostasis system 1 includes a probe 10 and a controller 12. Controller 12 includes a display 14, which is used to image tissues, identify internal bleeding sites, and select zones of a patient body for therapy.
  • Remote hemostasis system 1 is a specialized ultrasonic therapy system of the general type which is more fully described in U.S.S.N. 08/446,503, titled “Multifaceted Ultrasound Transducer Probe System And Methods For Its Use", filed May 22, 1995, the full disclosure of which has previously been incorporated herein by reference. The structure of the present system is also described in U.S. Patent Application Serial No.
  • probe 10 is adapted for use as an intracavity probe, typically being used by positioning a patient on a treatment table and transrectally inserting and positioning the treatment probe.
  • a transducer disposed within the probe housing images a tissue using a linear and/or sector scanning movement of the transducer relative to the housing.
  • the operator graphically selects a therapy volume, and also inputs treatment parameters.
  • the controller automatically linearly and angularly positions the transducer so that the active surface is focused at the target tissue.
  • the controller then activates the focused radiating surface of the transducer, applying therapeutic ultrasound energy to a target within the therapy zone.
  • probe 10 includes a probe housing 11 having a proximal end 16, a distal end 18, and an acoustic window 20.
  • the probe housing is shown without a membrane over window 20 for clarity.
  • the distal portion of housing 10 contains a transducer member having back-to-back active surfaces with focal geometries at a first and a second distance from the probe housing 11, respectively (see Fig. 5).
  • probe 10 is capable of applying HIFU therapy focused at a first distance 22 from housing 11 and also at a second distance 24 from housing 11.
  • first and second target volumes associated with these distances will at least be adjacent, and will preferably overlap, so that ultrasonic therapy can be applied to coagulate blood and/or cauterize tissues which lie throughout the volume between first distance 22 and second distance 24.
  • one or both of the back-to-back radiating surfaces comprise annular arrays, allowing electronic adjustments of the therapy distances, as described herein below.
  • probe housing 11 contains a transducer member 28 featuring two back-to-back therapeutic ultrasound focusing radiating surfaces having different focal geometries.
  • Probe housing 11 broadly includes a transducer region 30 near distal end 18 and a handle region 32 near proximal end 16.
  • Probe housing 11 may be formed from polyurediane, ABS plastic, or the like.
  • Transducer member 28 is disposed within an interior volume defined by transducer region 30, but does not contact probe housing 11 in the transducer region, being cantilevered from the handle region 32. Transducer member 28 is thus free to both rotate about the axis of transducer region 30, and to translate axially.
  • Window 20 provides passage for ultrasonic energy within a range of axial and angular positions of the radiating surfaces of transducer member 28, as seen in Fig. 2.
  • Disposed over the distal end 18 of transducer region 30 is an acoustic membrane 38.
  • Positioning mechanism 34 provides linear and sector scanning motion to transducer member 28 relative to housing 1 1, and also provides position feedback to controller 12 (see Fig. 1). Positioning mechanism 34 allows aiming of the radiating surfaces towards the internal bleeding site, selects between the back-to- back radiating surfaces, and also mechanically scans an ultrasonic imaging transducer array 45 attached to transducer member 28.
  • An exemplary positioning mechanism was described in U.S.S.N. 07/840,502, titled “Ultrasound System For Focal Disease Localization And Treatment", filed February 21,1992.
  • transducer member 28 includes a first radiating surface 50 having a relatively long focal length and a second radiating surface 52 having a relatively short focal length as compared to the long focal length.
  • First radiating surface 50 includes an inner region 56 and an outer region 54, while second radiating surface 52 similarly includes inner and outer regions 60, 58.
  • This separation of first radiating surface 50 and second radiating surface 52 into inner and outer regions allows additional control over the therapy depth by varying the relative phase of power supplied to the inner and outer regions, first and second radiating surfaces 50, 52 acting as simple annular phased arrays.
  • the use of annular phased arrays for controlling the depth of therapeutic ultrasound focusing is more fully explained in U.S. Patent No. 5,520,188, the full disclosure of which is herein incorporated by reference. Clearly, a larger number of regions provides additional flexibility in the focal depth.
  • transducer member 28 The radiating surfaces of transducer member 28 are coupled to acoustic membrane 38 by a coupling fluid contained within transducer region 30 of probe housing 11.
  • Acoustic membrane 38 is, in turn, coupled to the patient body by direct contact against tissue in the region of acoustic window 20.
  • transducer region 30 is inserted transrectally, transvaginally, transesophageally, or the like.
  • coupling membrane 38 is held against the patient's skin, either manually or using a table clamp attached to the probe, as known in the art.
  • Such extracorporal coupling of the radiating surface to the tissue of the patient body allows aiming of the radiating surfaces by repositioning probe 10 against a different region of the patient's skin, ideally by sliding acoustic membrane 38 against the skin.
  • the servo mechanisms of transducer positioning mechanism 34 may be used to precisely aim the radiating surfaces 50, 52.
  • a radiating surface comprising a two dimensional phased array would allow electronic aiming and focusing, analogous to the electronic variation in therapy depth provided by an annular array.
  • Acoustic membrane 38 may conveniently be integrated into a local tissue displacement mechanism for elasticity imaging. While transducer region 30 is held in coupling contact with the patient body, coupling fluid pressure P may be varied in a controlled fashion to displace the tissue which is adjacent to ultrasound transducer array 45. Acoustic membrane 38 ideally comprises an inelastic, non-distensible, thin membrane as described in U.S.S.N. 08/446,503, titled “Multifaceted Ultrasound Transducer Probe System And Methods For Its Use", filed May 22, 1993, typically being formed of PET, polyamide, or polyethylene, preferably being less than one wavelength of ultrasonic energy in thickness. Preferably, the tissue displacement mechanism operates at a regular interval, usually having a frequency between 1 and 50 Hz.
  • a registration system 60 comprises a processor 62, a memory 64, and display 14.
  • Positioning mechanism 34 (shown in Fig. 3) is located in the probe handle, and includes a rotational positioning motor 66 and a rotational position indicator 68.
  • imaging transducer 45 provides an image of a portion of a patient body having an internal bleeding site, typically using pulsed Doppler colorflow imaging, elasticity imaging, an angiogram, or the like.
  • Display 14 provides an image of the internal bleeding site.
  • a blood vessel 70 having a vascular breach 72 has released blood into the abdominal cavity.
  • the blood forms a low pressure pool 74, which has been identified using display 14.
  • imaging transducer 45 sweeps a section of the patient body to produce the image, either mechanically sweeping using motor 66, or electronically sweeping by use of a phased array.
  • a treatment volume for example, by manipulation of a trackball, a mouse, or the like.
  • a deep therapy volume 76 and a shallow therapy volume 78 have been defined.
  • Such therapy volumes targeting both the blood within the vessel and the vessel wall itself, promotes the formation of a plug to occlude the vessel and prevent blood leaking from vascular breach 72.
  • Imaging transducer 45 and radiating surfaces 50, 52 are supported on transducer member 28. This mechanical connection facilitates the aligning of a selected treatment target within a therapy volume to the internal bleeding site. Nonetheless, transducer member 28 will rotate between imaging and therapy, particularly when therapy is provided by radiating surface 50.
  • processor 62 manipulates transducer member 28 using rotational motor 68, and receives feedback from position indicator 68 to register the treatment target to the therapy zone adjacent to the internal bleeding site.
  • coagulation memory 64 maps that information on display 14, allowing efficient therapy zone management.
  • an organ 80 having an organ fracture 82 oozes blood from a large number of small vessels 84, resulting in a pool of blood 86 within the abdominal cavity.
  • a therapy volume 88 is selected which not only coagulates blood, but also cauterizes the soft tissue of the organ in the area adjacent to the organ fracture.
  • perfuse organs such as the liver and kidneys may be selectively cauterized to provide acoustic hemostasis without resorting to occlusion of a multiplicity of individual blood vessels.
  • a point-and-shoot remote hemostasis probe 90 comprises a radiating surface in the form of an annular array 92.
  • Annular array 92 applies therapies at depths arranging up to 3/2 the array aperture, the aperture typically being between two and ten inches (about 5 to about 25 cm).
  • Annular array 92 is carried by a housing 94, which also carries a mechanically oscillating linear imaging transducer array 96.
  • the imaging transducer and a global positioning system 98 provide information to a processor, which assembles a 3-D model of an internal region of a patient body.
  • the model is displayed in real time on a screen 100, with the model orientation updated to reflect movement of probe 90 from data supplied by global positioning system 98.
  • Point-and-shoot probe 90 is particularly advantageous for field medical treatment, allowing a paramedic to identify a site of internal bleeding, position the probe to target the site, select a proper therapy depth, and apply therapy to provide hemostasis before transporting the patient.

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Abstract

L'invention concerne des procédés et des appareils de coagulation sanguine à distance par ultrasons de haute intensité focalisés (HIFU). En l'occurence, pour réaliser une hémostase à distance, on identifie un site (72, 82) d'hémorragie interne et on focalise l'énergie ultrasonore de traitement (50, 52, 54, 58, 92) sur le site (72, 82), l'énergie (50, 52, 54, 58, 92) se focalisant à travers un tissu intermédiaire. L'appareil d'hémostase à distance comprend une surface focalisée rayonnant des ultrasons de traitement thérapeutique (50, 52, 54, 58, 92) et un capteur (45, 56, 60, 96) servant à identifier un site (72, 82) d'hémorragie interne. Un organe d'enregistrement (34, 62, 64, 66, 68) est couplé à la surface de rayonnement (50, 52, 54, 58). Le capteur (45, 56, 60) est conçu pour aligner une cible focale (76, 78, 88) sur le site d'hémorragie (72, 82). Le capteur (45, 56, 60, 96) comprend généralement un dispositif d'imagerie Doppler. Des agents facilitant l'hémostase peuvent être introduits sur le site (72, 82) pour être activés par l'énergie ultrasonore (50, 52, 54, 58, 92).
EP97941317A 1997-06-23 1997-06-23 Procedes et dispositifs d'hemostase acoustique Ceased EP0989822A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PCT/US1997/010848 WO1998058588A1 (fr) 1997-06-23 1997-06-23 Procedes et dispositifs d'hemostase acoustique
CA2253664A CA2253664C (fr) 1997-06-23 1998-11-04 Methodes et dispositifs pour produire l'homeostasie

Publications (2)

Publication Number Publication Date
EP0989822A1 true EP0989822A1 (fr) 2000-04-05
EP0989822A4 EP0989822A4 (fr) 2004-07-28

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EP97941317A Ceased EP0989822A4 (fr) 1997-06-23 1997-06-23 Procedes et dispositifs d'hemostase acoustique

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EP (1) EP0989822A4 (fr)
JP (1) JP2002516586A (fr)
CA (1) CA2253664C (fr)
WO (1) WO1998058588A1 (fr)

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US6635017B1 (en) * 2000-02-09 2003-10-21 Spentech, Inc. Method and apparatus combining diagnostic ultrasound with therapeutic ultrasound to enhance thrombolysis
WO2002024050A2 (fr) * 2000-09-19 2002-03-28 Focus Surgery, Inc. Procede et appareil pour effectuer un traitement tissulaire
JP4241038B2 (ja) 2000-10-30 2009-03-18 ザ ジェネラル ホスピタル コーポレーション 組織分析のための光学的な方法及びシステム
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JP2002516586A (ja) 2002-06-04
EP0989822A4 (fr) 2004-07-28

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