WO2009149042A2 - Dispositif ultrasonore de cryoablation endométriale - Google Patents

Dispositif ultrasonore de cryoablation endométriale Download PDF

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Publication number
WO2009149042A2
WO2009149042A2 PCT/US2009/045906 US2009045906W WO2009149042A2 WO 2009149042 A2 WO2009149042 A2 WO 2009149042A2 US 2009045906 W US2009045906 W US 2009045906W WO 2009149042 A2 WO2009149042 A2 WO 2009149042A2
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WO
WIPO (PCT)
Prior art keywords
ultrasound
tissue
tip
transducer
radiation surface
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
PCT/US2009/045906
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English (en)
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WO2009149042A3 (fr
Inventor
Eilaz Babaev
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Individual
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Individual
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Filing date
Publication date
Priority claimed from US12/132,058 external-priority patent/US20090299235A1/en
Priority claimed from US12/132,643 external-priority patent/US20090306550A1/en
Application filed by Individual filed Critical Individual
Publication of WO2009149042A2 publication Critical patent/WO2009149042A2/fr
Publication of WO2009149042A3 publication Critical patent/WO2009149042A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B18/0206—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques ultrasonic, e.g. for destroying tissue or enhancing freezing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A61B2017/4216—Operations on uterus, e.g. endometrium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0212—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument inserted into a body lumen, e.g. catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0231—Characteristics of handpieces or probes
    • A61B2018/0262—Characteristics of handpieces or probes using a circulating cryogenic fluid

Definitions

  • the present invention relates generally to an ultrasound assisted cryogenic surgical instrument, more particularly, to methods and devices utilizing ultrasound energy for treatment of the endometrium to control heavy uterine bleeding (menorrhagia) or other conditions that may benefit from tissue ablation.
  • Menorrhagia is a common problem with a variety of causes. Menorrhagia may be due to hormonal disturbances, uterine fibroids, polyps, overgrowth of the uterine lining (hyperplasia), or cancer. Furthermore, medical conditions, such as bleeding disorders or thyroid disease, may also contribute. When no specific anatomical cause is identified of the Menorrhagia, or if disturbances do not improve with hormone therapy, endometrial ablation ⁇ destruction of the uterine lining) may be an alternative to hysterectomy.
  • Hysterectomy has, for many years, been the most widely used treatment for menorrhagia. It can be performed abdominally, vaginally or laparoscopically.
  • hysterectomy is a major surgical procedure with inherent risks and the potential for complications.
  • hysterectomy yields a high level of satisfaction in that it guarantees the permanent cessation of menstrual bleeding, it is a major procedure.
  • Its invasiveness, morbidity, mortality and costs are well-known disadvantages of the procedure.
  • hysterectomy can lead to a variety of psychological and physical changes in women. For these various reasons, other less invasive treatments have been sought.
  • Endometrial ablation was adopted as a less invas ⁇ e alternative to hysterectomy. Endometrial ablation permits preservation of the uterus and reduces uterine bleeding in most patients. Endometrial ablation is less invasive, more convenient and less expensive than hysterectomy, at least when no complicating gynecologic conditions are involved. Women typically prefer endometrial ablation to hysterectomy because the surgery is less invasive, involves less risk of early menopause and sexual impairment, the changes wrought are less profound, and the hospital stay and convalescence arc shorter.
  • Endometrial ablation procedures can be accomplished through a variety of techniques including the application of heat, radiation or freezing.
  • Heat based ablation techniques include electrocautery and thermal balloon procedures.
  • Electrocautery is a method of endometrial ablation that uses instruments such as a ' ⁇ 'roller-ball" or wire loop and is performed under anesthesia in the operating room through a hysteroscope.
  • Thermal balloon endometrial ablation is a technique that is performed in an outpatient surgical center or in a doctor ' s office. A triangular balloon is placed into the uterus and filled with fluid. The fluid in the balloon is then heated for several minutes. During this time, most of the uterine lining is destroyed.
  • Radiotherapy techniques include microwave and laser ablation.
  • Microwave and laser ablation procedures tend to be painful even with local anesthesia and require highly skilled practitioners to administer the procedures.
  • Microwave ablation is also appropriate only for the well-formed uterus, because microwave endometrial ablation tends to be incomplete in women whose uterine cavity is hypertrophied or highly deformed.
  • Microwave ablation is also painful, because the cervix must be dilated to 9- mm in order to insert the microwave waveguide, and that dilatation process can be painful even under local anesthesia. In addition they carry risk of complications, which include hematometra, infection and internal organ injury.
  • Freezing of the uterine lining is also useful for endometrial ablation.
  • Cryoablation procedures involve deep tissue freezing which results in tissue destruction due to rupture of cells and/or cell organelles within the tissue.
  • Deep tissue freezing is effected by insertion of a tip of a cryosurgical device into the tissue, either endoscopically or laparoscopically, and a formation of, what is known in the art as, an ice-ball of frozen tissue around the tip,
  • Endometrial cryoablation is typically performed either by utilizing a single cryoprobe sequentially displaced to and operated at two or more ablation sites during a surgical procedure, or by utilizing up to three independent cryoprobcs inserted simultaneously in a uterus, for example, one in the uterine cavity and one in each of the cornua. and using sonography to confirm that the cryosurgical devices are properly positioned in the uterine cavity and to monitor the growth of the ice crystal during the treatment cycles.
  • Cryoablation techniques also include using a coolable balloon operable to cool the endometrium. This procedure includes inserting a balloon into the uterine cavity, filling the balloon to the proper size and cooling the balloon to freeze the endometrial tissue.
  • Freezing of tissue with a cryoprobe may result in tearing of the tissue that may be frozen to the device due to movement of the probe or patient. This may result in complications such as excessive bleeding during or after the procedure. This may occur even when attempts are made to free the device from the tissue by warming the eryoprobe before removal or other preventive procedures.
  • the present invention is directed towards apparatuses and methods for the selective ablation of unwanted tissue.
  • the invention is particularly applicable to the ablation of endometrial tissue for the treatment of menorrhagia.
  • Delivering ultrasonic and cryogenic energies simultaneously and/or sequentially the present invention may be used to destroy and/or remove unwanted and diseased tissue.
  • Combining the delivery of ultrasonic and cryogenic energy during treatment the present invention may provide advantages over existing methods and devices for removing unwanted and/or diseased tissue.
  • the apparatus in accordance with the present invention may be embodied as a hand held device and may comprise a body having a proximate end and a distal end.
  • the proximate end may also include a handle.
  • the distal end may comprise an ultrasonic- tip.
  • the body may define one or more chambers. Delivering a cryogenic fluid, such as, but not limited to, a liquid or gas, into one or more of the chambers may cool the ultrasonic tip. Transferring thermal energy away from the tissue, the ultrasonic tip when sufficiently cooled and placed proximate to the tissue may be used to ablate unwanted and/or diseased by freezing the tissue.
  • a cryogenic fluid such as, but not limited to, a liquid or gas
  • an ultrasonic transducer mechanically connected to the ultrasonic tip may be used to excite the ultrasonic tip and keep it free from the frozen tissue.
  • the present invention removes diseased and/or unwanted tissue without unduly damaging healthy tissues surround the targeted tissue.
  • the cryogenic fluid may be delivered to the chambers of the ultrasonic tip's body through one or more interior passages or similar elements. Acting as inlets, the interior passages introduce cryogenic fluid from a reservoir info a chamber. Acting as outlets, the interior passages permit cryogenic fluid to flow through and/or out of a chamber, A chamber may be designed to approach the distal end of the ultrasonic tip.
  • Exciting the distal end of the ultrasonic tip may enable the transmission of ultrasonic energy to a tissue.
  • the transmission of ultrasonic energy to a tissue may occur during, before, and/or after the transfer of thermal energy away from the tissue.
  • the transmission of ultrasonic energy and/or the transfer of thermal energy may occur through direct contact of the ultrasonic tip with the tissue.
  • an accumulation of frost on the tissue and/or the ultrasonic tip may act as a conduit for the transfer of thermal energy and/or transmission of ultrasonic energy.
  • Freezing of the uterine lining is aiso useful for endometrial ablation.
  • Cryosurgical procedures involve deep tissue freezing which results in tissue destruction due to rupture of cells and or cell organelles within the tissue.
  • Deep tissue freezing is effected by insertion of a tip of a cryosurgical device into the tissue, either abdominably, endoscopically or laparoscopically, and a formation of an ice-ball around the tip.
  • J000 ⁇ 6 With conventional cryotherapy, in order to effectively destroy a tissue there is a need to locate the isothermal surface of -40 degree C. at the periphery of the treated tissue, thereby exposing adjacent, usually healthy, tissues to the externa! portions of the ice-ball.
  • the application of temperatures of between about -40 degree C. and 0 degree C.
  • Another advantage of the present invention may be avoiding the adhesion of the ultrasound tip to the tissue during cryogenic ablation due to the ultrasonic vibration of the ultrasound tip.
  • Another advantage may be that the vibration created by the ultrasonic energy deli ⁇ ered to the tissue separates the unwanted and/or diseased tissue from healthy and/or wanted tissue.
  • Another advantage may be the destruction of microorganisms in the treatments by the delivered ultrasonic and/or cryogenic energy.
  • Another advantage may be the creation of an analgesic effect providing inherent pain relief on the treated tissue by the delivered ultrasonic energy.
  • a further advantage of the invention may be the delivering ultrasonic energy before, during, and/or after ablation to decrease healing time and/or provide other positive benefits to the surviving tissue.
  • Another advantage of the invention may be the selective destruction of the frozen tissue by matching the ultrasound vibrations to the resonant frequencies of the frozen tissue which may be different than the resonant frequencies of the normal tissues,
  • FlG, 1 depicts a dimensional view of an embodiment of the apparatus according to the present invention.
  • FlG. 2 depicts a cross-sectional view of an embodiment of the hand held portion of the device
  • FlG. 3 depicts a top cross-sectional view of an alternative embodiment of the hand held portion of the device.
  • FlG. 4 depicts a cross-sectional view of the distal end of an alternative embodiment of the ultrasound tip.
  • FIG. 5 shows a cross-sectional view of the distal end of an alternative embodiment of the ultrasound tip with a frost layer.
  • FIG. 6 depicts a cross-sectional view of the distal end of an alternative embodiment of the ultrasound tip
  • FIGS. 7A-7E depicts cross-sectional views of various alternative embodiments of the distal end of the ultrasound tip.
  • FIGS. 8A-8E depicts cross-sectional views of various alternative embodiments of the distal end of the ultrasound tip.
  • FIG. 9 depicts a cross-sectional view of the distal end of an alternative embodiment of the ultrasound tip.
  • FIG. 10 depicts a cross-sectional view of the distal end of an alternative embodiment of the ultrasound tip having an expandable balloon.
  • the present invention relates to devices and methods for the combination of use of ultrasonic energy and cryogenic cooling for tissue ablation.
  • the invention is particularly applicable for endometrial ablation for the treatment of menorrhagia.
  • Highly controllable, precise delivery of ultrasonic energy and cryogenic cooling allows precise destruction of endometrial tissue while minimizing damage to surrounding tissue.
  • the ultrasonic energy and cryogenic cooling may be delivered simultaneously and/or sequentially to the tissue being ablated.
  • the combination of ultrasonic energy treatments provides a synergistic effect that allows effective treatment at higher temperatures than is possible with cryogenic cooling alone.
  • cryogenic cooling may be herein referred to as the delivery of energy, it is of course the transfer of thermal energy from the tissue to the device that results in the cooling of the tissue.
  • FIGS, 1 - 10 relate generally to describe the invention in some of the aspects of its embodiments.
  • the apparatus of the present invention may be a hand held device with a housing 60 surrounding an ultrasound transducer 20 as shown in FIG, 1.
  • the housing 60 provides a surface for the surgeon to hold for manipulation of the device over the wound.
  • the housing 60 also may provide dampening and isolation so that the heat, electrical and mechanical energy emitted from the ultrasound transducer 20 do not interfere with the operator's control of the device.
  • the housing 60 may extend over a portion of the ultrasound transducer tip 30 to insulate the ultrasound transducer tip 30 and isolate portions of the proximal end of the ultrasound transducer tip 30 from contact with endometrial tissue.
  • the ultrasound transducer 20 is driven by an ultrasound generator 10.
  • the ultrasound generator 10 is typically powered with standard AC current which is electrically connected to an ultrasound transducer 20 through a cable 11 and activated with a hand or foot operated switch.
  • the ultrasonic transducer 20 is pulsed according to a driving signal generated by the ultrasound generator ⁇ 0 and transmitted to the ultrasonic transducer 20 by cable 11.
  • the driving signals as a function of time, may be rectangular, trapezoidal, sinusoidal, triangular or other signal types as would be recognized by those skilled in the art.
  • the ultrasound generator 10 may also be programmable to provide a rapid pulsed on-off signal to the ultrasound transducer 20 to modify the vibrational interaction between the transducer tip 30 and the tissue 80 which may control and limit friction, tissue attachment, standing wave production and temperature rise within the tissue.
  • This pulsed signal may vary between 0 to 100 % depending on the application.
  • the distal end of the ultrasound transducer 20 is attached to a transducer tip 30 for conditioning and directing the ultrasonic energy toward the tissue area selected for treatment.
  • the ultrasound waves are emitted at a frequency and amplitude,
  • the ultrasonic frequency may be used in embodiments that include low frequency or high frequency embodiments that operate within the range of 15 kHz and 20 mRz.
  • the preferred frequency range for the transducer tip 30 is 35 kHz to 50 kHz with a recommenced frequency of approximately 30 kHz.
  • the amplitude of the ultrasonic waves may be between 1 micron and 250 microns with a preferred amplitude in the range of 10 to 50 microns and a recommended amplitude of 20 microns.
  • Cryogenic cooling may be utilized to cool the transducer tip 30 and adjacent tissue 80.
  • the ultrasound transducer tip 30 may contain one or more interior passages 31 for transfer of a cryogenic fluid 55 through the transducer tip 30.
  • the delivery of cryogenic fluid 55 may be simultaneous or sequentially to the delivery of ultrasonic energy.
  • the cryogenic fluid 55 is also used to remove heat generated from the ultrasound energy within the transducer tip 30.
  • the interior passage 31 through which cryogenic fluid 55 flows through the transducer tip 30 may include an expansion shown as a chamber portion 32 in FIG. 2.
  • a cryogenic source 50 may be used to supply the cryogenic fluid 55.
  • One or more delivery tubes 51 are typically used to deliver the cryogenic fluid 55 from the cryogenic source to the transducer tip 30.
  • the cryogenic source 50 may include a refrigeration system that recycles the cryogenic fluid 55 through the transducer tip 30 or it may be a vented once-through system such as those using liquid nitrogen or liquid carbon dioxide.
  • a cryogenic source 50 may be a refrigeration system capable of recycling the cryogenic fluid 55 through the transducer tip 30.
  • the interior passage 31 layout of FIG. 3 may be preferred for use with a refrigeration system.
  • Typical examples include liquid/vapor compression type units that utilize a condensation-evaporation cycle or Joule-Thompson type refrigeration systems.
  • Joule-Thompson refrigeration systems utilize a pressurized gas that cools when decompressed such as, but not limited to, argon, air, carbon tetra-fluoride, xenon, krypton, nitrous oxide or carbon dioxide.
  • the gas used as a cryogenic fluid 55 is pressurized and then decompressed in an expansion chamber such as a chamber portion 32 resulting in c ⁇ oling of the gas within the transducer tip 30, J00 ⁇ 43]
  • the ultrasonic tip 30 may also contain one or more temperature sensors which may control the flow rate of cryogenic fluid 55 through the ultrasound transducer tip 30 to maintain a constant preselected temperature at the tip regardless of the ultrasound energy emitted from the tip.
  • a temperature controller may also be used to vary the temperature through a manually controllable or a preprogrammed cycle.
  • the ultrasound tip 30 may then be placed adjacent to the tissue 80 to be ablated to create an area of frozen tissue 85 as shown in FlG, 4.
  • the ultrasonic tip 30 provides an ultrasonically active distal end 35 as well as cryogenic energy to tissue 80 through direct contact or indirectly through an accumulation of frost 56 as shown in FIG. 5.
  • Creating the accumulation of frost 56 on distal end 35 of the ultrasonic tip 30 may be accomplished by allowing moisture from the air to condense and freeze on distal end 35.
  • an accumulation of frost 56 may be formed with a substance such as, but not limited to, water being placed on distal end 35 and allowed to freeze.
  • Cryosurgical procedures involve deep tissue freezing which results in tissue destruction due to rapture of cells and/or cell organelles within the tissue 80.
  • Deep tissue freezing is achieved by insertion of a tip of a cryosurgical device into the tissue 80, cither vaginally, endoscopically or laparoscopically, and a formation of an ice-ball around the tip from the tissue to be removed.
  • the diameter of the ball should be substantially larger than the region of tissue 80 to be treated, a constraint derived from the specific profile of temperature distribution across the ice-ball.
  • the ice-bail may reach healthy tissue 80 before it reaches the tissue to be treated, and decision making of whether to continue the process of freezing, risking a damage to adjacent healthy tissues, or to halt the process of freezing, risking a non-complete destruction of the treated tissue, must be made,
  • the cryogenic cooling of the ultrasound tip also has therapeutic value associated with wound treatment.
  • the cryogenic fluid 55 used to cool the transducer tip 30 will also cool the surface of the wound. Cooling an incision wound is common practice to reduce the edema, pain, swelling and/or inflammation associated with wound treatment.
  • the ultrasound energy is highly controllable and may be applied in procedures customized for each patient and situation.
  • the use of ultrasound energy may also be customized to utilize the differences in resonant frequencies between the frozen tissue and tissues not frozen to resonate the ultrasonic vibrations with tissue cells and elements of tissue ceils to maximize disruption of frozen tissues and minimize impacts on tissues that may not be frozen or may be of other tissue types.
  • the synergism between the cryogenic energy and ultrasonic energy can be utilized to minimize negative effects.
  • the ultrasound energy emitted from the ultrasound transducer 20 may have a radial wave component and a lateral or longitudinal wave component.
  • the magnitudes of the components are a function of the ultrasound transducer 20 used, the characteristics of the signal driver and the characteristics of the ultrasound tip 30.
  • a variety of geometries are available for use for the ultrasound tip 30.
  • Specific features of the ultrasound tip 30 may be placed at locations along the axial length of the ultrasound tip corresponding with node and antinode positions of the ultrasound waves. For example, to minimize vibration, it may be desirable to locate the delivery tube 51 connection at a node point with no vibrational amplitude.
  • the distal end of the ultrasound transducer tip 30 may have a significant impact on the relative magnitudes of the radial wave component size and the lateral or longitudinal wave component size.
  • Available ultrasound tip geometries include oval, flat, curved, concave, ellipsoid, rounded or oval distai ends.
  • the embodiment depicted in FlG. 6 may be useful for the ablation of large regions of tissue.
  • the distal end of the ultrasonic tip may have various sizes and geometric shapes of the radiation surface 40 such as flat, concave, convex, rounded and/or angled.
  • FIGS. 7C and 8D show various embodiments of the radiation surface 40 that will concentrate or focus the ultrasound energy
  • FIG. 7D shows a cylindrical shaped ultrasound tip 30 that maybe particularly useful for minimizing radial wave components.
  • An ellipsoid shaped ultrasound tip as shown in FIG. 6 may be useful for maximizing radial wave components along certain portions of the ultrasound tip 30.
  • a cone distal end. depicted in FIG, 8 A may be useful the precise ablation of small regions of tissue.
  • a disposable cover 36 matching the geometric conformation the of distal end may be used to cover the distal end of the ultrasound tip 30.
  • the surface of the ultrasound tip may be smooth or have various roughness features to increase abrasion or reduce surface contact with the tissue 80
  • FIG. 9 presents an alternative embodiment showing round protrusions over the surface of ultrasonic tip 30.
  • Other possible roughness features may include waves, ridges, pins, cones or random granular elements of various sizes.
  • a detachable ultrasound transducer tip 30 can allow a surgeon to vary the geometric shape of the distal end as appropriate either between procedures or during the course of a procedure.
  • Another embodiment of the present invention includes an ultrasound tip
  • the balloon end may be a flexible membrane that is compact for insertion and positioning and may be folded within the ultrasound tip 30.
  • the flexible membrane is tillable with a fluid when positioned.
  • the fluid may be a liquid of a gas, preferably cryogenic fluid 55 may be used to fill the flexible membrane.
  • This embodiment as depicted may be particularly useful for the ablation of large regions without repositioning the device.
  • a triangular shape may be particularly useful that would approximately correspond with the shape of the endometrial tissue being ablated.
  • the membrane may be constructed of a material that is fijlable to a substantially predetermined fixed size and shape, or a membrane that may be of an adjustable size changeable by varying the fluid pressure within the balloon based on patient requirements.
  • the ultrasound tip 30 can be a single piece unit or composed of one or more individual separate pieces that are detachable from the device. This allows interchangeability of portions of different embodiments of the tip as well as easier cleaning/sterilization of portions of the device and/or allows construction of disposable single-use portions of the ultrasound transducer tip 30.
  • the transducer tip 30 is typically made from a metal such as alloys of titanium, aluminum and/or stainless steel. The portions of the ultrasound transducer tip 30 may also be made from plastic for disposable single-use embodiments of selected portions or protective coverings of the transducer tip 30.
  • the ultrasound tip 30 may be coated to further enhance the ability of the ultrasound tip 30 to remain free within the frozen tissue 85.
  • fluorocarbons titanium nitride, polyvinylidene fluoride or ⁇ oly(tetrafluoroethylene) are examples for materials that would be recognized by those skilled in the art for coating a cryogenic ultrasound tip useful with the present invention.
  • a method in accordance with the present invention comprises the steps of transmitting ultrasonic energy to and transferring thermal energy from a tissue to be ablated.
  • the transfer of thermal energy from the tissue may proceed, follow, and/or occur simultaneously with the transmission of ultrasonic energy to tissue.
  • Transferring thermal energy from the tissue may be accomplished by providing cryogenic fluid 55 to distal end 35 and placing distal end 35 proximate to and/or in contact with the tissue to be ablated.
  • Transmitting ultrasonic energy to the tissue may be accomplished by exciting distal end 35 by activating transducer 20 and placing distal end 35 proximate to and/or in contact with the tissue.
  • cryogenic energy and the ultrasonic energy may be applied sequentially to the tissue to be ablated.
  • a sequential application may begin by exciting distal end 35, placing the distal end 35 proximate to and/or in contact with the frozen tissue 85, and then providing cryogenic fluid 55 to the distal end 35.
  • the sequence may be modified so that the sequence would begin by providing cryogenic fluid 55 to the distal end 35, allowing an accumulation of frost 56 to form on the distal end 35, placing the distal end 35 proximate to and/or in contact with the frozen tissue 85, and then activating the ultrasonic transducer. Sequential application of ultrasonic energy without providing cryogenic fluid 55 may result in warmthing of the distal end 35 to facilitate removal of the device.
  • the application of ultrasonic energy may have an antimicrobial effect for the treated and surrounding tissue.
  • the application of ultrasound energy is known to produce cellular disruption and microbial inactivation due to cavitation in gases, liquids and/or tissues to which it is applied.
  • the cavitations and the ultrasound energy are able to inactivate microbes in the area of treatment through cellular disruption, denaturization and other means. This effect can reduce the chance of infection, thereby greatly enhancing patient recovery, since post-surgical infection can be a major impediment to optimal patient recovery.
  • cryogenic energy to a tissue is synonymous with transferring thermal energy away from a tissue.
  • delivery of ultrasonic energy to a tissue is synonymous with the transmission of ultrasonic energy to a tissue.
  • delivery of cryogenic energy to a tissue is synonymous with transferring heat away from a tissue to lower tissue temperature, it should be further appreciated that as used herein the delivery of ultrasonic energy to a tissue is synonymous with the transmission of ultrasonic energy to a tissue.
  • the invention relates generally to an ultrasound assisted cryogenic surgical instrument, more particularly, to methods and devices utilizing ultrasound energy for treatment of the endometrium to control heavy uterine bleeding (menorrhagia) or other conditions that may benefit from tissue ablation.

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  • Surgical Instruments (AREA)

Abstract

La présente invention porte sur un instrument chirurgical cryogénique assisté par ultrasons, plus particulièrement sur des procédés et des dispositifs utilisant l'énergie ultrasonore pour le traitement de l'endomètre afin de contrôler une hémorragie utérine lourde (ménorragie) ou d'autres états. Le dispositif de la présente invention comprend un générateur ultrasonore, un transducteur ultrasonore, un embout de transducteur à l'extrémité distale du transducteur ultrasonore et une surface de rayonnement. Le rayonnement ultrasonore est dirigé sur le tissu devant subir l'ablation. On fait circuler une solution cryogénique dans l'embout ultrasonore pour transférer l'énergie thermique loin du tissu pour congeler le tissu devant subir une ablation par la fourniture d'un effet synergique à l'aide du rayonnement ultrasonore.
PCT/US2009/045906 2008-06-03 2009-06-02 Dispositif ultrasonore de cryoablation endométriale Ceased WO2009149042A2 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US12/132,058 2008-06-03
US12/132,058 US20090299235A1 (en) 2008-06-03 2008-06-03 Ultrasonic Endometrial Cryoablation Device
US12/132,643 US20090306550A1 (en) 2008-06-04 2008-06-04 Ultrasonic Endometrial Cryoablation Method
US12/132,643 2008-06-04

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WO2009149042A2 true WO2009149042A2 (fr) 2009-12-10
WO2009149042A3 WO2009149042A3 (fr) 2010-03-11

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Cited By (7)

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WO2012063655A1 (fr) * 2010-11-08 2012-05-18 オリンパス株式会社 Dispositif de traitement par ultrasons
WO2017015480A1 (fr) * 2015-07-21 2017-01-26 GI Scientific, LLC Accessoire d'endoscope avec portail de sortie à réglage angulaire
US10506918B2 (en) 2011-02-16 2019-12-17 The General Hospital Corporation Optical coupler for an endoscope
US10548467B2 (en) 2015-06-02 2020-02-04 GI Scientific, LLC Conductive optical element
US10642020B2 (en) 2014-09-23 2020-05-05 Scott Miller Optical coupler for optical imaging visualization device
CN112702962A (zh) * 2018-09-24 2021-04-23 史赛克欧洲运营有限责任公司 具有限定顶吸孔的突出部的超声尖端
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