WO2003086171A2 - Doppler directed suturing and compression device and method - Google Patents

Doppler directed suturing and compression device and method Download PDF

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Publication number
WO2003086171A2
WO2003086171A2 PCT/US2003/010551 US0310551W WO03086171A2 WO 2003086171 A2 WO2003086171 A2 WO 2003086171A2 US 0310551 W US0310551 W US 0310551W WO 03086171 A2 WO03086171 A2 WO 03086171A2
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WO
WIPO (PCT)
Prior art keywords
accordance
uterine artery
doppler
distal end
compressing
Prior art date
Application number
PCT/US2003/010551
Other languages
French (fr)
Other versions
WO2003086171A3 (en
Inventor
Fred H. Burbank
Michael L. Jones
Greig E. Altieri
R. J. Serra
Original Assignee
Vascular Control Systems, 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 Vascular Control Systems, Inc. filed Critical Vascular Control Systems, Inc.
Priority to JP2003583202A priority Critical patent/JP2005521530A/en
Priority to EP03718227A priority patent/EP1489976B1/en
Priority to AU2003221827A priority patent/AU2003221827B2/en
Priority to AT03718227T priority patent/ATE493940T1/en
Priority to CA2481170A priority patent/CA2481170C/en
Priority to DE60335612T priority patent/DE60335612D1/en
Publication of WO2003086171A2 publication Critical patent/WO2003086171A2/en
Publication of WO2003086171A3 publication Critical patent/WO2003086171A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0482Needle or suture guides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/2812Surgical forceps with a single pivotal connection
    • A61B17/282Jaws
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122Clamps or clips, e.g. for the umbilical cord
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42Gynaecological or obstetrical instruments or methods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, 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
    • A61B5/026Measuring blood flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/06Measuring blood flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters

Definitions

  • the present invention relates to devices, systems, and processes useful for locating and compressing a uterine artery of a female human patient, and more particularly to devices and systems capable of easily locating, compressing, ligating and/or monitoring or characterizing the blood flow through a uterine artery.
  • Doppler ultrasound device and the element which passes through the tissue of the patient to occlude the uterine artery can be, for some patients and for some procedures, difficult to maintain. Additionally, the devices and methods described in the '601 patent do not necessarily take advantage of the structure and symmetry of the female human anatomy to facilitate occlusion of a uterine artery. The devices and methods of the '601 patent also are not well adapted for performing blood flow studies of a uterine artery.
  • Physicians including gynecologists, have ligated the uterine artery surgically by using metal vascular clips or suture material, access having been achieved by surgical dissection. These surgical procedures have been performed by open abdominal surgery and laparoscopically, and require a great deal of surgical skill to access, identify, dissect, and ligate the uterine artery. This high skill requirement has limited the use of surgical ligation of the uterine arteries as a clinical alternative for treatment of uterine fibroids and other uterine disorders.
  • Ultrasound devices have been proposed for measuring blood flow in a blood vessel. See, e.g., U.S. Patent Nos. 5,411,028, 5,453,575, 5,535,747, and 5,967,987
  • Ligation devices have previously been proposed. These prior ligation devices have typically been used in laparoscopic procedures, and have typically required that the anatomical feature of interest be dissected or visualized prior to ligation of that feature. Other ligation devices require the penetration of a tissue bundle encapsulating the anatomical vessel in order to perform location and ligation of the vessel.
  • Ligation has also been effected by surgically utilizing metal vascular clips.
  • the disadvantage in this technique is that the procedure must be performed laparoscopically and requires a great deal of surgical skill to access, identify, dissect, and ligate the uterine arteries, and is permanent. Because of the high skilled involved, the process has limited the use of surgical ligation of the uterine arteries as a clinical alternative to uterine fibroid treatment.
  • a device useful for compressing a uterine artery of a female human patient comprises a first jaw having a distal end and a first distal end face, a second jaw having a distal end and a second distal end face, a pivot, the first jaw and the second jaw movably attached at the pivot, wherein the first and second jaws are configured and arranged so that when the first and second jaws are pivoted relative to each other at the pivot in a first direction to a relatively closed orientation, the first and second distal end faces are oriented toward each other; and at least one Doppler crystal mounted in one of the first and second distal end faces, the at least one Doppler crystal having a direction of view, the direction of view being toward the other of the first and second distal end face in the relatively closed orientation.
  • a method of occluding a uterine artery of a female human patient comprises pushing a compressing member toward the uterine artery until the compressing member reaches the vaginal fornix, pushing the compressing member upwardly to distend the vaginal wall at the vaginal fornix adjacent to and on two substantially opposite sides of the uterine artery, and compressing the uterine artery with the compressing member.
  • FIG. 1 illustrates simplified cross-sectional view of a uterus, cervix, and vagina of a female human in a coronal plane.
  • Fig. 2 illustrates a plan view taken at line 2-2 in Fig. 1 along an axial or transverse plane.
  • FIG. 3 illustrates a side (right sagital) elevational view of an exemplary device in accordance with the present invention in position adjacent to the cervix of the patient and invaginating the vaginal wall of the patient.
  • Fig. 4 illustrates a view similar to that illustrated in Fig. 3 , with a compressed uterine artery.
  • the inventors herein have discovered that the uterine arteries of female humans typically are about 3 cm or less from the vaginal wall at the vaginal fornix where the uterine artery meets the uterus, although the uterine arteries for a single patient sometimes are spaced at slightly different distances (see distances XI and X2 in Fig. 1).
  • the inventors herein have also discovered that the right uterine artery is typically positioned between about the 1 and 5 o'clock (see Fig.
  • the cervix can be used as a platform and a landmark from which to locate and access a uterine artery because of the axial symmetry of the cervix and it's generally cylindrical or frustoconical exterior shape. See also U.S. application serial number 09/908,815, filed July 20, 2001, to Fred Burbank et al.
  • FIGs. 1 and 2 illustrate two different views of the uterus, cervix, vagina, and uterine arteries of a female human patient. Because reference will be made throughout this description to some of these anatomical structures, a brief discussion of this portion of the female human anatomy may prove useful.
  • a uterus U includes a uterine cavity UC.
  • the vagina V has a vaginal wall VW which extends upward to the vaginal fornix VF.
  • the cervix C is (typically) centrally located and extends from the uterus U to a point typically somewhat below the vaginal fornix NF, and includes a cervical os CO which leads to the uterine cavity UC.
  • Uterine arteries UA1 and UA2 lead to the uterus U from the inferior iliac artery (not illustrated).
  • the orientations of the uterine arteries UA1 and UA2 will be described in terms of a clock face, i.e., the positions of the uterine arteries will be identified as corresponding to particular times on a clock.
  • 12 o'clock is the anterior direction from the center of the cervical os CO
  • 6 o'clock is posterior therefrom
  • 3 o'clock is laterally to the right (the patient's left side, see Fig. 2)
  • 9 o'clock is laterally to the left (the patient's right side, see Fig. 2).
  • the use of the clock face as a reference frame is used merely to simplify the discussions herein, and other reference frames, such as degrees or radians from a known or ascertainable reference line, can be interchangeably used herein.
  • the devices in accordance with the present invention are sized to be insertable through the vagina of a female human patient, along a side of the exterior of the cervix, and to the vaginal wall at the vaginal fornix.
  • Manipulation of a compressor according to the present invention compresses the uterine artery, at least partially, and optionally completely, stopping the blood flow through the artery. As described in the '815 application, cessation of blood flow through the uterine artery can have beneficial effects for the patient, including the treatment of fibroids by limiting the blood supplied to the fibroids in the uterus.
  • Fig. 3 illustrates an exemplary compression and ligation device 100 in accordance with the present invention.
  • the device 100 can optionally, and preferably, include one or more Doppler crystals or chips to permit location of a uterine artery or arteries or other blood vessels, and monitoring the blood flow through the vessel(s).
  • the device 100 includes a handle 102 including first and second arms 104, 106, and a distal clamping and/or ligation portion 108.
  • the two arms 104, 106 are joined together at a hinge or pivot 110 about which the two arms can move.
  • Attached to or formed in at least the distal portion 108 is a pair of hollow, tube-like guide channels 112, 114 which provide a guided pathway for a suture leader 132 with an attached length of suture or ligation material 138 to be passed around a blood vessel of interest, as described in greater detail below.
  • the guide channels 112, 114 extend proximally so that they are more easily accessible from the proximal end of the device 100.
  • the device 100 is illustrated in Fig. 3 in a position to one side of the cervix C (see Figs. 1, 2) after having been advanced upwardly to invaginate the vaginal wall VW at the vaginal fornix VF.
  • the uterine artery UA on that side of the uterus is illustrated in a position somewhat between the open jaws of the device 100, and prior to being either compressed or ligated.
  • the distal portion 108 of the device 100 includes at least one, and optionally a plurality, of Doppler chips or crystals 116 mounted in or otherwise attached to the distal ends of the distal portion.
  • the direction of view of the Doppler chip 116 is laterally across the device itself outward from the end face 144 and toward the end face 146.
  • the device 100 can include a plurality of Doppler chips, mounted at one distal end face 144, a chip 116, 118 in each of the end faces 144, 146, a plurality of chips mounted in one end face, a plurality of chips mounted in both end faces, and/or combinations thereof.
  • the Doppler chip(s) can send Doppler signals at and receive Doppler signals from the uterine artery UA.
  • the Doppler chip(s) can be used to determine the location of the uterine artery UA relative to the end faces 144, 146 of the device 100. More specifically, the Doppler data generated by the Doppler chip(s) can be used to determine when the vaginal wall has been invaginated sufficiently that the uterine artery UA is between the end faces of the device 100.
  • the Doppler data can be reviewed to establish what is a base blood flow through the artery for future reference.
  • This knowledge of the placement of and blood flow through the uterine artery can be useful to the practitioner for deciding, among other things, whether to compress and/or ligate the artery, or merely to establish a baseline blood flow through the artery for future reference.
  • each of the guide channels 112, 114 includes a lumen 120, 122, which extends between open distal and proximal openings or ports, 126, 128, 124, 130.
  • a suture leader 132 is sized to be able to be advanced within either or both lumina 120, 122, and has a distal end 134 and a proximal end 136 to which is attached a length of suture or ligation material 138.
  • the suture leader is sized and formed of a material so that it can be pushed up through one of the guide channels 112, out the distal opening 126, penetrate the vaginal wall, pass through the tissues behind the vaginal wall and behind the uterine artery UA, again through the vaginal wall, into the distal port 130 of the guide channel 112, and through the other guide channel 114 (see Fig. 4). As the material 138 is attached to the proximal end 136 of the leader 132, the material is pulled along this same path.
  • the length of the suture leader is selected so that it can loop through the two guide channels, as described above, and the distal end 134 can be retrieved from the proximal opening 124, with the proximal end 136 of the leader still exposed proximally of the opening 128.
  • one suitable leader 132 is formed of 0.0020 inch (outer diameter) stainless steel wire and is about 20 inches long.
  • Other suitable materials include nitinol (NiTi), and the leader's cross-sectional shape can be any of those well known to those of skill in the art, including rectangular, square, and round.
  • the cross- sectional shapes of the suture leader 132 and the lumina 120, 122 of the guide channels 112, 114 can be selected together to ease passage of the suture leader through the lumen, while minimizing the dead space between the suture leader and the guide channel.
  • the material of the ligation material 138 can be either resorbable, for which removal of the material from the patient is not necessary, or non-resorbable, for which eventual removal of the material from the patient is indicated for most patients.
  • the jaws 140, 142 of the device 100 are preferably generally C-shaped in at least a portion of their length.
  • the curve of the C-shape creates an area or volume between the two jaws 140, 142, in which the tissue of the vaginal wall VW, etc., can reside when thejaws are clamped down onto a uterine artery, with less or no compression.
  • the reduction in or lack of compression of these more proximal tissues can assist in maintaining the position of the uterine artery UA relative to the end faces 144, 146.
  • the optional provision in the device 100 of an area or volume between thejaws 140, 142 in which entrapped tissues are exposed to less pressure from thejaws is another aspect of the present invention.
  • the distance between the pivot 110 and the distal openings 126, 130 is at least about 2 inches, and preferably about 3 inches, to provide this volume to accommodate proximal tissues.
  • the Doppler chip(s) 116, 118 are in signal communication with a
  • Doppler signal processing and/or display device 152 via leads 148, 150.
  • leads 148, 150 As such devices 152 are well understood by those of skill in the art, so further description will be given herein.
  • the devices of the present invention preferably include at least one, and optionally a plurality of Doppler ultrasound crystals oriented with the viewing direction of the crystals pointed laterally, as suggested by the arrows in Fig. 3. While a plurality of crystals can be advantageous in providing more data about the flow of blood through the uterine artery of interest, the additional data requires additional manipulation that can increase the complexity and cost of the device. Thus, it may in some circumstances be advantageous to provide fewer, or only a single, crystal to reduce the complexity of the Doppler data that must be interpreted.
  • the Doppler crystals 116, 188 are preferably positioned at the distal end faces 144, 146 of the device so that any data derived from the signals received by the Doppler crystals can be more easily correlated to the distance of the uterine artery from the distal end, and can verify that the uterine artery is between the two end faces.
  • the Doppler chip(s) can be positioned about 1 cm proximally of the channel opening on the same jaw 140, 142 as the Doppler crystal.
  • the Doppler crystals can be integrated into the devices of the present invention, e.g., molded into the device itself, or alternatively can be removably mounted in the device.
  • the Doppler crystals 116, 118 can each be in a Doppler probe which is received in a correspondingly configured holder (see, e.g., a hole or cutouts in one or both of the jaws 140, 142) formed in distal portions of the device. While many commercially available Doppler probes are suitable in the present invention, a Vascular Technology, Inc. (Lowell, MA) 8 MHz Doppler probe, or a Koven 8 MHz Doppler probe (Koven, St. Louis, MO), can be used as a Doppler probe 214i, 216i.
  • Doppler crystal will change the viewing angle of the crystal.
  • One aspect of the present invention is the use of Doppler crystals which permit Doppler data to be gathered at distances up to about 3 cm, so that when the compressor on which the Doppler crystals are mounted is pushed against the vaginal wall at the vaginal fornix VF, the Doppler crystals will received signals back from the uterine artery of interest.
  • Doppler crystals are suitable in the present invention, those which operate at about 8 MHz have been found to be particularly suitable.
  • the signals from the Doppler crystals or probes are transmitted to a suitable signal processor 152 (see Fig. 3), which displays data derived from the signals.
  • the data from each of the Doppler crystals is either manually or automatically examined to ascertain if the waveform received by the crystal is representative of the blood flow through a uterine artery UA1. Because the Doppler crystals are selected to have relatively narrow angles of view, the process of examining the signals received by each crystal will reveal which crystal is pointed most directly at the uterine artery. [0037] Again with reference to the drawing figures, other aspects of the present invention include methods of finding, evaluating the blood flow through, compressing, and/or ligating a uterine artery.
  • a device in accordance with the present invention such as device 100, is positioned inside the vagina of the patient, with the jaws 140, 142 positioned to one side of the cervix C in the vaginal fornix VF.
  • the jaws 140, 142 are opened, and the device 100 further advanced upwardly (toward the uterine artery behind the vaginal wall).
  • the distal ends of each of the jaws generally in the area of the openings 126, 130, and of the end faces 144, 146, push and invaginate the vaginal wall on opposite sides of the uterine artery.
  • the presence of the uterine artery generally between the end faces 144, 146 can be confirmed by the Doppler data sent and received by the chip(s) 116, 118; if the uterine artery is present, a Doppler signai indicative of an artery will be observed, while absence of the uterine artery will be detected by the lack of such blood flow data.
  • the device 100 can be repositioned and/or the vaginal wall again invaginated.
  • the practitioner has several options.
  • the practitioner can verify that the uterine artery UA is directly between the end faces 144, 146, by moving the device 100 slightly distally and slightly proximally. For example, if the Doppler data indicates a stronger Doppler signal when the device 100 is moved distally (upwardly), then the uterine artery is located more distal than the previous location of the device; similarly, if distal movement of the device produces a weaker Doppler signal, then the uterine artery is located more proximal.
  • the practitioner can easily and quickly determine that the uterine artery is located substantially between the end faces 144, 146, and is located proximally of the guide channel distal openings 126, 130.
  • the practitioner can choose between compressing the uterine artery by closing the jaws of the device, pushing the suture leader 132 behind the uterine artery to pass the material 138 around the uterine artery, or both (see Fig. 4).
  • a preferred embodiment of the present invention includes: the uterine artery is first compressed by manipulating the handles 104, 106 to compress the uterine artery between the end faces 144,146; the suture leader 132 is passed through the vaginal wall, behind the uterine artery, and again out through the vaginal wall, pulling the material 138 behind the uterine artery and out the proximal opening 124; the suture material is separated from the leader and formed into a ligature to ligate the uterine artery in a closed, compressed conditiorl; and thejaws are opened and the device removed, leaving the ligature in place closing the uterine artery.
  • the Doppler data from the Doppler chip(s) can be used to determine if blood flow has stopped in the uterine artery.
  • the practitioner can release thejaws, remove the ligature, or both from the patient.
  • the practitioner opens thejaws, and retracts the device 100 from along the one side of the cervix of the patient.
  • the term therapeutically effective time and its equivalents are used as in U.S. Patent Application No. 09/556,934, filed April 21, 2000, by Burbank et al., and U.S.
  • the method(s) described above can optionally be performed on the other uterine artery, either at substantially the same time, or after the first uterine artery has been compressed.
  • the ligature is used as the mechanism by which the uterine artery or arteries are compressed for most or all of the therapeutically effective time, because the volume of tissue compressed by the relatively thin material 138 is much less than that compressed by the jaws 140, 142.
  • the end faces 144, 146 may optionally be formed in or as a part of an integral or removable pad (not illustrated) at the distal ends of the jaws 140, 142. Further optionally, the pad(s) can configured or formed of a material which provides additional friction or grip between the vaginal wall VW and the device 100.
  • the variations of the textures may include plastic ridges, foam, a textile type padding, metal or plastic teeth or fangs that protrude from the clamp face, or combinations thereof, to provide for more grip or bite into the tissue.
  • the present invention also relates to devices, systems, and processes which can be useful in treating dysfunctional uterine bleeding (DUB).
  • DUB dysfunctional uterine bleeding
  • DUB can be a very frustrating and troublesome condition because the actual cause of the bleeding is, by definition, unknown.
  • DUB is a diagnosis of exclusion; if a woman has menorrhagia and no organic abnormality can be identified, she is given the diagnosis of DUB.
  • Women with DUB are debilitated just as are women with fibroids and menorrhagia: they can be socially restricted during times of high menstrual blood loss and are anemic.
  • aspects of the present invention relate to treating a patient who is diagnosed with DUB by compressing one or both uterine arteries, either serially or simultaneously, so that the uterine blood supply is greatly diminished or completely cut off. Without the blood supplied by the uterine arteries, the uterus stops bleeding, which can permit the medical practitioner to better diagnose the patient's condition. Without being limited to a particular theory, it is also posited herein that at least some cases of DUB can be treated effectively by uterine artery compression and/or ligation as described herein, that is, that DUB will not reoccur upon reestablishment of the blood supply to the uterus through the uterine arteries. To put it somewhat colloquially, the apparatus and methods of the present invention can be used to 'reset' the uterus by going through a period of induced anoxia or hypoxia. The Bateman article, mentioned briefly above, lends support to this hypothesis.
  • the present invention also includes as an aspect the treatment of bleeding associated with Caesarian section.
  • Caesarian delivery results in at least two sources of post partum bleeding: blood loss at the Caesarian incision site; and blood loss at the placental separation site.
  • blood loss at the Caesarian incision site is typically achieved by suturing the two margins of the incision firmly together. The pressure of the sutures slows blood flow at the incision site and clot then forms; however, until sufficient suturing has been accomplished, blood loss occurs.
  • Another aspect of the present invention is the use of devices and/or the performance of methods in accordance with the present invention instead of, or in conjunction with, these prior suturing methods to treat Caesarian delivery bleeding. More specifically, devices and/or methods of the present invention are used and/or implemented to slow or stop blood flow to the uterus through the uterine arteries immediately after a baby is delivered. Subsequently, Caesarian incision repair can be performed in a manner that optimizes surgical closure, without worry about blood loss control at the time of closure.
  • the present invention also includes as an aspect the treatment of bleeding associated with Post Partum Hemorrhage (PPH).
  • PPH is defined in the medical literature as the estimated loss of more than 500 ml of blood following delivery of a baby. It can occur for a wide variety of reasons and occurs following at least 5% of deliveries. Most often it occurs because the uterus fails to contract following placental separation (uterine atony). Without adequate post partum uterine contractions, blood does not slow enough in the uretoplacental arteries to clot. Without clot formation in the uretoplacental arteries, bleeding from the uretoplacental arteries persists.
  • the present invention extends at least to include devices and methods including combinations of all of the features and steps described above.
  • the Doppler chip(s) described herein can be incorporated into any of the exemplary devices described herein, arranged at the distal end(s) of the device(s) as will be readily apparent to one of skill in the art.
  • methods of the present invention can include, but are not limited to, any one or combinations of the steps described above.
  • any of the above described devices and methods which are described as useful for occluding a single uterine artery can be incorporated into bilateral devices and methods, that is, two of the unilateral devices can be joined into a single, bilateral device, with each of the two unilateral devices positioned in the bilateral device to access and/or locate a single uterine artery, and the steps of a method for accessing and/or locating a single uterine artery can be performed bilaterally, either serially or simultaneously.
  • Devices in accordance with the present invention can be formed of any of numerous materials, as will be readily apparent to those of skill in the art.
  • the devices can be formed of: surgical stainless steel, nitinol (NiTi), titanium, or other biocompatible and preferably sterilizable metals; any of a number of thermoplastic and thermoset materials which are sufficiently biocompatible and sterilizable; and combinations thereof.

Abstract

A compression and ligation device includes a pair of jaws including one or more Doppler chips oriented to send and receive Doppler signals across the jaws, to assist a practitioner in determining whether or not a uterine artery is between the jaws. A suture leader with an attached suture can be pushed through a channel on one of the jaws, through tissue behind the uterine artery, into another channel on the other jaw, and proximally out the device so that the practitioner can ligate the artery and effect hemostasis.

Description

DOPPLER DIRECTED SUTURING AND COMPRESSION DEVICE AND
METHOD
BACKGROUND OF THE INVENTION
Field of the Invention
[0001] The present invention relates to devices, systems, and processes useful for locating and compressing a uterine artery of a female human patient, and more particularly to devices and systems capable of easily locating, compressing, ligating and/or monitoring or characterizing the blood flow through a uterine artery.
Brief Description of the Related Art
[0002] It has been proposed that occlusion of the uterine arteries of a human female patient can kill myomata, i.e., fibroids, because of the relative frailty of the fibroids to anoxia or hypoxia, and the relatively high resistance of uterine tissues to anoxia or hypoxia. See Burbank, Fred, M.D., et al, Uterine Artery Occlusion by Embolization or Surgery for the Treatment of Fibroids: A Unifying Hypothesis- Transient Uterine Ischemia, The Journal of the American Association of Gynecologic Laparoscopists, November 2000, Vol. 7, No. 4 Supplement, pp. S3-S49. U.S. Patent No. 6,254,601, to Fred Burbank et al, entitled "Methods for Occlusion of the Uterine Arteries", describes numerous devices and methods useful for occluding a uterine ■artery by penetrating the tissue of the patient to access the uterine artery. The devices and methods described in Burbωk '601 have been useful in occluding a uterine artery; there have been some difficulties involved with their use. [0003] Specifically, the aligned orientations of the imaging device, e.g.,
Doppler ultrasound device, and the element which passes through the tissue of the patient to occlude the uterine artery can be, for some patients and for some procedures, difficult to maintain. Additionally, the devices and methods described in the '601 patent do not necessarily take advantage of the structure and symmetry of the female human anatomy to facilitate occlusion of a uterine artery. The devices and methods of the '601 patent also are not well adapted for performing blood flow studies of a uterine artery.
[0004] Current devices available for uterine artery identification and characterization include two-dimensional Doppler color flow ultrasound systems with vaginal, abdominal, or intracavity probes. Typical machines are manufactured and distributed by General Electric Medical Systems, Toshiba, and Acuson, among other sources.
[0005] These machines require an ultrasound technologist to utilize the vaginal probe and position the probe sensor array within the vagina, near the cervix, while looking at the ultrasound machine's display screen, position the probe, and then select an appropriate setting to evaluate blood flow. Currently available devices thus require a high degree of skill to identify and then position the Doppler gate approximately to obtain an optimum signal for characterizing the blood flow. During this time, the probe must be held in as steady a position as possible to eliminate erroneous readings and signals. As will be readily appreciated by those of skill in the art, prior devices are therefore difficult to use successfully. [0006] Physicians, including gynecologists, have ligated the uterine artery surgically by using metal vascular clips or suture material, access having been achieved by surgical dissection. These surgical procedures have been performed by open abdominal surgery and laparoscopically, and require a great deal of surgical skill to access, identify, dissect, and ligate the uterine artery. This high skill requirement has limited the use of surgical ligation of the uterine arteries as a clinical alternative for treatment of uterine fibroids and other uterine disorders.
[0007] Ultrasound devices have been proposed for measuring blood flow in a blood vessel. See, e.g., U.S. Patent Nos. 5,411,028, 5,453,575, 5,535,747, and 5,967,987
[0008] In an article published in 1964, Bateman reported that uterine artery vessel ligation or division, achieved via intra-abdominal surgery similar to hysterectomy, was effective in treating menorfhagia both with and without myomectomy. Bateman, W., M.D., "Treatment of intractable menorrhagia by bilateral uterine vessel interruption", 89 Am. J. Obstet. Gynecol. 825-827 (Harcourt Health Sciences, July 15, 1964). While Bateman reported some success, this procedure involves opening the abdominal cavity, with the known attendant risks and disadvantages.
[0009] Ligation devices have previously been proposed. These prior ligation devices have typically been used in laparoscopic procedures, and have typically required that the anatomical feature of interest be dissected or visualized prior to ligation of that feature. Other ligation devices require the penetration of a tissue bundle encapsulating the anatomical vessel in order to perform location and ligation of the vessel.
[0010] Ligation has also been effected by surgically utilizing metal vascular clips. The disadvantage in this technique is that the procedure must be performed laparoscopically and requires a great deal of surgical skill to access, identify, dissect, and ligate the uterine arteries, and is permanent. Because of the high skilled involved, the process has limited the use of surgical ligation of the uterine arteries as a clinical alternative to uterine fibroid treatment.
[0011] There therefore remains a need in the art to develop apparatus and methods which further assist a medical practitioner in accessing, occluding, and/or measuring the blood flow characteristics in a uterine artery.
SUMMARY OF THE INVENTION
[0012] According to a first aspect of the invention, a device useful for compressing a uterine artery of a female human patient comprises a first jaw having a distal end and a first distal end face, a second jaw having a distal end and a second distal end face, a pivot, the first jaw and the second jaw movably attached at the pivot, wherein the first and second jaws are configured and arranged so that when the first and second jaws are pivoted relative to each other at the pivot in a first direction to a relatively closed orientation, the first and second distal end faces are oriented toward each other; and at least one Doppler crystal mounted in one of the first and second distal end faces, the at least one Doppler crystal having a direction of view, the direction of view being toward the other of the first and second distal end face in the relatively closed orientation. [0013] According to yet another aspect of the present invention, a method of occluding a uterine artery of a female human patient, the patient having a uterus, a cervix with a cervical os, and a vaginal wall with a vaginal fornix, comprises pushing a compressing member toward the uterine artery until the compressing member reaches the vaginal fornix, pushing the compressing member upwardly to distend the vaginal wall at the vaginal fornix adjacent to and on two substantially opposite sides of the uterine artery, and compressing the uterine artery with the compressing member.
[0014] Still other objects, features, and attendant advantages of the present invention will become apparent to those skilled in the art from a reading of the following detailed description of embodiments constructed in accordance therewith, taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The invention of the present application will now be described in more detail with reference to preferred embodiments of the apparatus and method, given only by way of example, and with reference to the accompanying drawings, in which:
[0016] Fig. 1 illustrates simplified cross-sectional view of a uterus, cervix, and vagina of a female human in a coronal plane.
[0017] Fig. 2 illustrates a plan view taken at line 2-2 in Fig. 1 along an axial or transverse plane.
[0018] Fig. 3 illustrates a side (right sagital) elevational view of an exemplary device in accordance with the present invention in position adjacent to the cervix of the patient and invaginating the vaginal wall of the patient.
[0019] Fig. 4 illustrates a view similar to that illustrated in Fig. 3 , with a compressed uterine artery.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0020] Referring to the drawing figures, like reference numerals designate identical or corresponding elements throughout the several figures.
[0021] The inventors herein have discovered that the uterine arteries of female humans typically are about 3 cm or less from the vaginal wall at the vaginal fornix where the uterine artery meets the uterus, although the uterine arteries for a single patient sometimes are spaced at slightly different distances (see distances XI and X2 in Fig. 1). The inventors herein have also discovered that the right uterine artery is typically positioned between about the 1 and 5 o'clock (see Fig. 2) positions, and more frequently between about 2 and 4 o'clock; and that there is typically symmetry between the uterine arteries, i.e., that the left uterine artery is typically positioned between about the 7 and 11 o'clock positions, and more frequently between about 8 and 10 o'clock. The inventors herein have also discovered that the cervix can be used as a platform and a landmark from which to locate and access a uterine artery because of the axial symmetry of the cervix and it's generally cylindrical or frustoconical exterior shape. See also U.S. application serial number 09/908,815, filed July 20, 2001, to Fred Burbank et al. ("'815 application"), co-assigned with the present application, for additional discussions of the anatomy of the uterus, cervix, and vaginal wall, the entire contents of which are incorporated by reference herein. [0022] Figs. 1 and 2 illustrate two different views of the uterus, cervix, vagina, and uterine arteries of a female human patient. Because reference will be made throughout this description to some of these anatomical structures, a brief discussion of this portion of the female human anatomy may prove useful. A uterus U includes a uterine cavity UC. The vagina V has a vaginal wall VW which extends upward to the vaginal fornix VF. The cervix C is (typically) centrally located and extends from the uterus U to a point typically somewhat below the vaginal fornix NF, and includes a cervical os CO which leads to the uterine cavity UC. Uterine arteries UA1 and UA2 lead to the uterus U from the inferior iliac artery (not illustrated). In this following descriptions, the orientations of the uterine arteries UA1 and UA2 will be described in terms of a clock face, i.e., the positions of the uterine arteries will be identified as corresponding to particular times on a clock. In this context, 12 o'clock is the anterior direction from the center of the cervical os CO, 6 o'clock is posterior therefrom, 3 o'clock is laterally to the right (the patient's left side, see Fig. 2), and 9 o'clock is laterally to the left (the patient's right side, see Fig. 2). As will be readily apparent to those of skill in the art, the use of the clock face as a reference frame is used merely to simplify the discussions herein, and other reference frames, such as degrees or radians from a known or ascertainable reference line, can be interchangeably used herein. [0023] The devices in accordance with the present invention are sized to be insertable through the vagina of a female human patient, along a side of the exterior of the cervix, and to the vaginal wall at the vaginal fornix. [0024] Manipulation of a compressor according to the present invention compresses the uterine artery, at least partially, and optionally completely, stopping the blood flow through the artery. As described in the '815 application, cessation of blood flow through the uterine artery can have beneficial effects for the patient, including the treatment of fibroids by limiting the blood supplied to the fibroids in the uterus.
[0025] Fig. 3 illustrates an exemplary compression and ligation device 100 in accordance with the present invention. An aspect of the present invention includes that the device 100 can optionally, and preferably, include one or more Doppler crystals or chips to permit location of a uterine artery or arteries or other blood vessels, and monitoring the blood flow through the vessel(s).
[0026] Turning now to Fig. 3, the device 100 includes a handle 102 including first and second arms 104, 106, and a distal clamping and/or ligation portion 108. The two arms 104, 106 are joined together at a hinge or pivot 110 about which the two arms can move. Attached to or formed in at least the distal portion 108 is a pair of hollow, tube-like guide channels 112, 114 which provide a guided pathway for a suture leader 132 with an attached length of suture or ligation material 138 to be passed around a blood vessel of interest, as described in greater detail below. Preferably, the guide channels 112, 114 extend proximally so that they are more easily accessible from the proximal end of the device 100.
[0027] The device 100 is illustrated in Fig. 3 in a position to one side of the cervix C (see Figs. 1, 2) after having been advanced upwardly to invaginate the vaginal wall VW at the vaginal fornix VF. The uterine artery UA on that side of the uterus is illustrated in a position somewhat between the open jaws of the device 100, and prior to being either compressed or ligated.
[0028] The distal portion 108 of the device 100, according to preferred embodiments of the present invention, includes at least one, and optionally a plurality, of Doppler chips or crystals 116 mounted in or otherwise attached to the distal ends of the distal portion. As suggested by the arrow illustrated in Fig. 3, the direction of view of the Doppler chip 116 is laterally across the device itself outward from the end face 144 and toward the end face 146. Further optionally, the device 100 can include a plurality of Doppler chips, mounted at one distal end face 144, a chip 116, 118 in each of the end faces 144, 146, a plurality of chips mounted in one end face, a plurality of chips mounted in both end faces, and/or combinations thereof. [0029] The directions of view of the chip or chips incorporated into the device
100 are selected so that, as illustrated in Fig. 3, when the vaginal wall is invaginated by the open jaws of the device 100, the Doppler chip(s) can send Doppler signals at and receive Doppler signals from the uterine artery UA. With the direction(s) of view of the Doppler chip(s) selected in this manner, the Doppler chip(s) can be used to determine the location of the uterine artery UA relative to the end faces 144, 146 of the device 100. More specifically, the Doppler data generated by the Doppler chip(s) can be used to determine when the vaginal wall has been invaginated sufficiently that the uterine artery UA is between the end faces of the device 100. Furthermore, the Doppler data can be reviewed to establish what is a base blood flow through the artery for future reference. This knowledge of the placement of and blood flow through the uterine artery can be useful to the practitioner for deciding, among other things, whether to compress and/or ligate the artery, or merely to establish a baseline blood flow through the artery for future reference.
[0030] Turning back to Fig. 3, each of the guide channels 112, 114 includes a lumen 120, 122, which extends between open distal and proximal openings or ports, 126, 128, 124, 130. A suture leader 132 is sized to be able to be advanced within either or both lumina 120, 122, and has a distal end 134 and a proximal end 136 to which is attached a length of suture or ligation material 138. The suture leader is sized and formed of a material so that it can be pushed up through one of the guide channels 112, out the distal opening 126, penetrate the vaginal wall, pass through the tissues behind the vaginal wall and behind the uterine artery UA, again through the vaginal wall, into the distal port 130 of the guide channel 112, and through the other guide channel 114 (see Fig. 4). As the material 138 is attached to the proximal end 136 of the leader 132, the material is pulled along this same path. It is therefore also an aspect of the present invention that the length of the suture leader is selected so that it can loop through the two guide channels, as described above, and the distal end 134 can be retrieved from the proximal opening 124, with the proximal end 136 of the leader still exposed proximally of the opening 128. By way of example and not of limitation, one suitable leader 132 is formed of 0.0020 inch (outer diameter) stainless steel wire and is about 20 inches long. Other suitable materials include nitinol (NiTi), and the leader's cross-sectional shape can be any of those well known to those of skill in the art, including rectangular, square, and round. Further optionally, the cross- sectional shapes of the suture leader 132 and the lumina 120, 122 of the guide channels 112, 114 can be selected together to ease passage of the suture leader through the lumen, while minimizing the dead space between the suture leader and the guide channel. Additionally, the material of the ligation material 138 can be either resorbable, for which removal of the material from the patient is not necessary, or non-resorbable, for which eventual removal of the material from the patient is indicated for most patients.
[0031] The jaws 140, 142 of the device 100 are preferably generally C-shaped in at least a portion of their length. The curve of the C-shape creates an area or volume between the two jaws 140, 142, in which the tissue of the vaginal wall VW, etc., can reside when thejaws are clamped down onto a uterine artery, with less or no compression. The reduction in or lack of compression of these more proximal tissues can assist in maintaining the position of the uterine artery UA relative to the end faces 144, 146. As will be readily appreciated by those of skill in the art, if the tissues proximal of the uterine artery UA are under pressure, this can tend to push the tissues and the uterine artery upwardly (distally) away from the device 100, and out of the space immediately between the end faces 144, 146. Therefore, the optional provision in the device 100 of an area or volume between thejaws 140, 142 in which entrapped tissues are exposed to less pressure from thejaws (see Fig. 4) is another aspect of the present invention. According to one embodiment of the present invention, the distance between the pivot 110 and the distal openings 126, 130, is at least about 2 inches, and preferably about 3 inches, to provide this volume to accommodate proximal tissues. As will be readily appreciated by those of skill in the art, smaller or larger dimensions can be alternatively selected, and optionally only one of the jaws can be formed with a C-shape or similar shape. [0032] The Doppler chip(s) 116, 118 are in signal communication with a
Doppler signal processing and/or display device 152 via leads 148, 150. As such devices 152 are well understood by those of skill in the art, so further description will be given herein.
[0033] As discussed above, the devices of the present invention preferably include at least one, and optionally a plurality of Doppler ultrasound crystals oriented with the viewing direction of the crystals pointed laterally, as suggested by the arrows in Fig. 3. While a plurality of crystals can be advantageous in providing more data about the flow of blood through the uterine artery of interest, the additional data requires additional manipulation that can increase the complexity and cost of the device. Thus, it may in some circumstances be advantageous to provide fewer, or only a single, crystal to reduce the complexity of the Doppler data that must be interpreted.
[0034] The Doppler crystals 116, 188 are preferably positioned at the distal end faces 144, 146 of the device so that any data derived from the signals received by the Doppler crystals can be more easily correlated to the distance of the uterine artery from the distal end, and can verify that the uterine artery is between the two end faces. By way of example and not of limitation, the Doppler chip(s) can be positioned about 1 cm proximally of the channel opening on the same jaw 140, 142 as the Doppler crystal. The Doppler crystals can be integrated into the devices of the present invention, e.g., molded into the device itself, or alternatively can be removably mounted in the device. By way of example and not of limitation, the Doppler crystals 116, 118 can each be in a Doppler probe which is received in a correspondingly configured holder (see, e.g., a hole or cutouts in one or both of the jaws 140, 142) formed in distal portions of the device. While many commercially available Doppler probes are suitable in the present invention, a Vascular Technology, Inc. (Lowell, MA) 8 MHz Doppler probe, or a Koven 8 MHz Doppler probe (Koven, St. Louis, MO), can be used as a Doppler probe 214i, 216i.
[0035] Those of skill in the art will recognize that the frequency of the
Doppler crystal will change the viewing angle of the crystal. One aspect of the present invention is the use of Doppler crystals which permit Doppler data to be gathered at distances up to about 3 cm, so that when the compressor on which the Doppler crystals are mounted is pushed against the vaginal wall at the vaginal fornix VF, the Doppler crystals will received signals back from the uterine artery of interest. Thus, while many different Doppler crystals are suitable in the present invention, those which operate at about 8 MHz have been found to be particularly suitable. [0036] The signals from the Doppler crystals or probes are transmitted to a suitable signal processor 152 (see Fig. 3), which displays data derived from the signals. According to yet further aspects of the present invention, the data from each of the Doppler crystals is either manually or automatically examined to ascertain if the waveform received by the crystal is representative of the blood flow through a uterine artery UA1. Because the Doppler crystals are selected to have relatively narrow angles of view, the process of examining the signals received by each crystal will reveal which crystal is pointed most directly at the uterine artery. [0037] Again with reference to the drawing figures, other aspects of the present invention include methods of finding, evaluating the blood flow through, compressing, and/or ligating a uterine artery. A device in accordance with the present invention, such as device 100, is positioned inside the vagina of the patient, with the jaws 140, 142 positioned to one side of the cervix C in the vaginal fornix VF. The jaws 140, 142 are opened, and the device 100 further advanced upwardly (toward the uterine artery behind the vaginal wall). The distal ends of each of the jaws, generally in the area of the openings 126, 130, and of the end faces 144, 146, push and invaginate the vaginal wall on opposite sides of the uterine artery. The presence of the uterine artery generally between the end faces 144, 146 can be confirmed by the Doppler data sent and received by the chip(s) 116, 118; if the uterine artery is present, a Doppler signai indicative of an artery will be observed, while absence of the uterine artery will be detected by the lack of such blood flow data. [0038] In the event the uterine artery is not between the end faces 144, 146, the device 100 can be repositioned and/or the vaginal wall again invaginated. When the Doppler data indicates that the uterine artery UA is between the end faces 144, 146, the practitioner has several options. First, however, the practitioner can verify that the uterine artery UA is directly between the end faces 144, 146, by moving the device 100 slightly distally and slightly proximally. For example, if the Doppler data indicates a stronger Doppler signal when the device 100 is moved distally (upwardly), then the uterine artery is located more distal than the previous location of the device; similarly, if distal movement of the device produces a weaker Doppler signal, then the uterine artery is located more proximal. By using this methodology, the practitioner can easily and quickly determine that the uterine artery is located substantially between the end faces 144, 146, and is located proximally of the guide channel distal openings 126, 130.
[0039] With the device 100, and more particularly the jaws 140, 142, positioned with the uterine artery UA between the end faces 144, 146, the practitioner can choose between compressing the uterine artery by closing the jaws of the device, pushing the suture leader 132 behind the uterine artery to pass the material 138 around the uterine artery, or both (see Fig. 4). While the exact sequence is not critical, a preferred embodiment of the present invention includes: the uterine artery is first compressed by manipulating the handles 104, 106 to compress the uterine artery between the end faces 144,146; the suture leader 132 is passed through the vaginal wall, behind the uterine artery, and again out through the vaginal wall, pulling the material 138 behind the uterine artery and out the proximal opening 124; the suture material is separated from the leader and formed into a ligature to ligate the uterine artery in a closed, compressed conditiorl; and thejaws are opened and the device removed, leaving the ligature in place closing the uterine artery. During any part of a method of the present invention, the Doppler data from the Doppler chip(s) can be used to determine if blood flow has stopped in the uterine artery. [0040] Once it has been established that the blood flow through the uterine artery or arteries has stopped for a therapeutically effective period of time, the practitioner can release thejaws, remove the ligature, or both from the patient. In the context of device 100, the practitioner opens thejaws, and retracts the device 100 from along the one side of the cervix of the patient. As used herein, the term therapeutically effective time and its equivalents are used as in U.S. Patent Application No. 09/556,934, filed April 21, 2000, by Burbank et al., and U.S. Patent Application No. 09/908,815, filed July 20, 2001, by Burbank et al., the entireties of both of which are incorporated herein by reference. As most patients have two uterine arteries in which a practitioner may want to effect hemostasis, the method(s) described above can optionally be performed on the other uterine artery, either at substantially the same time, or after the first uterine artery has been compressed. [0041] According to a preferred aspect of the present invention, the ligature is used as the mechanism by which the uterine artery or arteries are compressed for most or all of the therapeutically effective time, because the volume of tissue compressed by the relatively thin material 138 is much less than that compressed by the jaws 140, 142. With less tissue experiencing the compressive pressure and force of the material 138, there can be less concern over pressure-induced tissue necrosis. [0042] The end faces 144, 146 may optionally be formed in or as a part of an integral or removable pad (not illustrated) at the distal ends of the jaws 140, 142. Further optionally, the pad(s) can configured or formed of a material which provides additional friction or grip between the vaginal wall VW and the device 100. The variations of the textures may include plastic ridges, foam, a textile type padding, metal or plastic teeth or fangs that protrude from the clamp face, or combinations thereof, to provide for more grip or bite into the tissue.
[0043] The present invention also relates to devices, systems, and processes which can be useful in treating dysfunctional uterine bleeding (DUB). As the skilled artisan readily appreciates, DUB can be a very frustrating and troublesome condition because the actual cause of the bleeding is, by definition, unknown. Stated somewhat differently, DUB is a diagnosis of exclusion; if a woman has menorrhagia and no organic abnormality can be identified, she is given the diagnosis of DUB. Women with DUB are debilitated just as are women with fibroids and menorrhagia: they can be socially restricted during times of high menstrual blood loss and are anemic. Other aspects of the present invention relate to treating a patient who is diagnosed with DUB by compressing one or both uterine arteries, either serially or simultaneously, so that the uterine blood supply is greatly diminished or completely cut off. Without the blood supplied by the uterine arteries, the uterus stops bleeding, which can permit the medical practitioner to better diagnose the patient's condition. Without being limited to a particular theory, it is also posited herein that at least some cases of DUB can be treated effectively by uterine artery compression and/or ligation as described herein, that is, that DUB will not reoccur upon reestablishment of the blood supply to the uterus through the uterine arteries. To put it somewhat colloquially, the apparatus and methods of the present invention can be used to 'reset' the uterus by going through a period of induced anoxia or hypoxia. The Bateman article, mentioned briefly above, lends support to this hypothesis.
[0044] The present invention also includes as an aspect the treatment of bleeding associated with Caesarian section. Caesarian delivery results in at least two sources of post partum bleeding: blood loss at the Caesarian incision site; and blood loss at the placental separation site. Generally, natural mechanisms control blood loss at the placental separation site, while blood loss at the Caesarian incision site is typically achieved by suturing the two margins of the incision firmly together. The pressure of the sutures slows blood flow at the incision site and clot then forms; however, until sufficient suturing has been accomplished, blood loss occurs. Because suturing the Caesarian incision site is performed under urgent circumstances, to minimize blood loss, suturing quality of the incision is performed as if the uterus were composed of one layer of tissue, instead of three. Consequently, the outcome of this prior method is suboptimal at the endometrial, myometrial, and serosal levels. Thus another aspect of the present invention is the use of devices and/or the performance of methods in accordance with the present invention instead of, or in conjunction with, these prior suturing methods to treat Caesarian delivery bleeding. More specifically, devices and/or methods of the present invention are used and/or implemented to slow or stop blood flow to the uterus through the uterine arteries immediately after a baby is delivered. Subsequently, Caesarian incision repair can be performed in a manner that optimizes surgical closure, without worry about blood loss control at the time of closure.
[0045] The present invention also includes as an aspect the treatment of bleeding associated with Post Partum Hemorrhage (PPH). PPH is defined in the medical literature as the estimated loss of more than 500 ml of blood following delivery of a baby. It can occur for a wide variety of reasons and occurs following at least 5% of deliveries. Most often it occurs because the uterus fails to contract following placental separation (uterine atony). Without adequate post partum uterine contractions, blood does not slow enough in the uretoplacental arteries to clot. Without clot formation in the uretoplacental arteries, bleeding from the uretoplacental arteries persists. [0046] Many treatments exist for hemorrhage secondary to uterine atony, including massage of the uterus through the abdominal wall, administration of drugs that encourage myometrial contraction (e.g., oxytocin, methylergonovine, and prostaglandins), uterine cavity packing with, e.g., cloth materials, balloon tamponade of the uterine cavity, bilateral surgical ligation of the uterine artery, ovarian arteries, or internal iliac artery, bilateral uterine artery embolization, suturing through the uterus (e.g., B-Lynch Brace technique), and hysterectomy. Many of the existing treatments are ineffective; others are overly complex, invasive, and slow to initiate. [0047] According to aspects of the present invention, when it is recognized that bleeding has not stopped normally as it should after delivery, devices and/or methods in accordance with the present invention can be employed as described herein to slow or stop PPH.
[0048] The present invention extends at least to include devices and methods including combinations of all of the features and steps described above. By way of example and not of limitation, the Doppler chip(s) described herein can be incorporated into any of the exemplary devices described herein, arranged at the distal end(s) of the device(s) as will be readily apparent to one of skill in the art. In a similar manner, methods of the present invention can include, but are not limited to, any one or combinations of the steps described above. Furthermore, any of the above described devices and methods which are described as useful for occluding a single uterine artery can be incorporated into bilateral devices and methods, that is, two of the unilateral devices can be joined into a single, bilateral device, with each of the two unilateral devices positioned in the bilateral device to access and/or locate a single uterine artery, and the steps of a method for accessing and/or locating a single uterine artery can be performed bilaterally, either serially or simultaneously. [0049] Devices in accordance with the present invention can be formed of any of numerous materials, as will be readily apparent to those of skill in the art. By way of example and not of limitation, the devices can be formed of: surgical stainless steel, nitinol (NiTi), titanium, or other biocompatible and preferably sterilizable metals; any of a number of thermoplastic and thermoset materials which are sufficiently biocompatible and sterilizable; and combinations thereof. [0050] While the invention has been described in detail with reference to preferred embodiments thereof, it will be apparent to one skilled in the art that various changes can be made, and equivalents employed, without departing from the scope of the invention. Each of the aforementioned documents is incorporated by reference herein in its entirety.

Claims

WHAT IS CLAIMED IS:
1. A device useful for compressing a uterine artery of a female human patient comprising: a first jaw having a distal end and a first distal end face; a second jaw having a distal end and a second distal end face; a pivot, the first jaw and the second jaw movably attached at the pivot; wherein the first and second jaws are configured and arranged so that when the first and second jaws are pivoted relative to each other at the pivot in a first direction to a relatively closed orientation, the first and second distal end faces are oriented toward each other; and at least one Doppler crystal mounted in one of the first or second distal end faces, the at least one Doppler crystal having a direction of view, the direction of view being toward the other of the first and second distal end face in the relatively closed orientation.
2. A device in accordance with Claim 1, wherein the at least one Doppler crystal is releasably mounted in the one of the first and second distal end faces.
3. A device in accordance with Claim 1, wherein the at least one Doppler crystal is integrally formed in the one of the first and second distal end faces.
4. A device in accordance with Claim 1, wherein the at least one Doppler crystal comprises at least one Doppler crystal mounted in each of the first and second distal end faces.
5. A device in accordance with Claim 1, wherein the at least one Doppler crystal comprises a plurality of Doppler crystals mounted in each of the first and second distal end faces.
6. A device in accordance with Claim 1, wherein the at least one Doppler crystal comprises a plurality of Doppler crystals mounted in the one of the first and second distal end faces.
7. A device in accordance with Claim 1, further comprising: a first guide channel formed on the first jaw, the first guide channel having a proximal opening, a distal opening, and a lumen extending between the proximal and distal openings; and a second guide channel formed on the second jaw, the second guide channel having a proximal opening, a distal opening, and a lumen extending between the proximal and distal openings.
8. A device in accordance with Claim 7, wherein the first guide channel distal opening and the second guide channel distal opening are oriented toward each other when the device is in the relatively closed orientation.
9. A device in accordance with Claim 7, further comprising: a suture leader sized and configured to pass through the first guide channel lumen and the second guide channel lumen; and a length of ligation material attached to the suture leader.
10. A device in accordance with Claim 1, wherein at least one of the first and second jaws has a shaped selected to allow tissue to accumulate proximal of the first and second distal end faces when the device is in the relatively closed orientation.
11. A device in accordance with Claim 10, wherein at least one of the first and second jaws are C-shaped.
12. A device in accordance with Claim 10, wherein both of the first and second jaws are C-shaped.
13. A method of occluding a uterine artery of a female human patient, the patient having a uterus, a cervix with a cervical os, and a vaginal wall with a vaginal fomix, comprising: pushing a compressing member toward the uterine artery until the compressing member reaches the vaginal fomix; pushing the compressing member upwardly to distend the vaginal wall at the vaginal fomix adjacent to and on two substantially opposite sides of the uterine artery; and compressing the uterine artery with the compressing member.
14. A method in accordance with Claim 13, further comprising: sensing the blood flow through the uterine artery with at least one
Doppler crystal.
15. A method in accordance with Claim 14, wherein the step of sensing blood flow comprises sensing blood flow along a direction of view of the at least one Doppler crystal between said two substantially opposite sides of the uterine artery.
16. A method in accordance with Claim 14, wherein the step of compressing the uterine artery is continued for a therapeutically effective time after the step of sensing blood flow indicates that blood flow through the uterine artery has stopped.
17. A method in accordance with Claim 13, wherein the step of compressing the uterine artery comprises: compressing the uterine artery between two end faces of two pivoting jaws.
18. A method in accordance with Claim 13, wherein the step of compressing the uterine artery comprises: ligating the uterine artery with a length of ligation material.
19. A method in accordance with Claim 18, wherein the step of ligating comprises passing a length of ligation material through the vaginal wall, through tissue distally behind the uterine artery, and again through the vaginal wall.
20. A method in accordance with Claim 18, wherein the step of ligating comprises temporarily ligating with a resorbable ligation material.
21. A method in accordance with Claim 18, wherein the step of ligating comprises ligating with a non-resorbable ligation material.
22. A method in accordance with Claim 21 , further comprising: removing the non-resorbable ligation material.
23. A method in accordance with Claim 13, further comprising: selecting a patient who has at least one fibroid; and performing the compressing step to at least reduce the blood supply to the at least one fibroid.
24. A method in accordance with Claim 13, further comprising: selecting a patient who has DUB; and performing the compressing step to at least slow bleeding from the uterus.
25. A method in accordance with Claim 13, further comprising: selecting a patient who is bleeding from a Caesarian incision; and performing the compressing step to at least slow bleeding from the
Caesarian incision.
26. A method in accordance with Claim 13, further comprising: selecting a patient who is has PPH; and performing the compressing step to at least slow bleeding from the uterus. '
27. A method in accordance with Claim 13, further comprising: removing the compressing member.
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AU2003221827A AU2003221827B2 (en) 2002-04-04 2003-04-04 Doppler directed suturing and compression device and method
AT03718227T ATE493940T1 (en) 2002-04-04 2003-04-04 DOUBLE CONTROLLED SEWING AND COMPRESSION DEVICE
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1594407A2 (en) * 2003-02-05 2005-11-16 Vascular Control Systems, Inc. Vascular clamp for ceasarian section
JP2007521851A (en) * 2003-11-25 2007-08-09 バスキュラー・コントロール・システムズ・インコーポレイテッド Occlusion devices for asymmetric uterine artery structures

Families Citing this family (39)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2442362C (en) * 2001-03-28 2009-08-11 Vascular Control Systems, Inc. Method and apparatus for the detection and ligation of uterine arteries
US7875036B2 (en) 2004-10-27 2011-01-25 Vascular Control Systems, Inc. Short term treatment for uterine disorder
US20060276808A1 (en) * 2005-06-06 2006-12-07 Arnal Kevin R Minimally Invasive Methods and Apparatus for Accessing and Ligating Uterine Arteries with Sutures
US20090043295A1 (en) * 2005-06-06 2009-02-12 Ams Research Corporation Fibroid Treatment Methods and Devices
WO2006133289A1 (en) * 2005-06-06 2006-12-14 Ams Research Corporation Devices and methods for ligating uterine arteries
US20070005061A1 (en) * 2005-06-30 2007-01-04 Forcept, Inc. Transvaginal uterine artery occlusion
ATE535281T1 (en) * 2006-06-21 2011-12-15 Mick Radio Nuclear Instr Inc SPLIT RING BRACHYTHERAPY DEVICE FOR CERVICAL BRACHYTHERAPY TREATMENT WITH A SPLIT RING BRACHYTHERAPY DEVICE
US20090093758A1 (en) * 2006-07-24 2009-04-09 Yossi Gross Fibroid treatment apparatus and method
US8177794B2 (en) 2006-10-05 2012-05-15 Tyco Healthcare Group Lp Flexible endoscopic stitching devices
EP2083702B1 (en) 2006-10-05 2019-02-13 Covidien LP Axial stitching device
US20080114382A1 (en) * 2006-11-03 2008-05-15 Ams Research Corporation Uterine Artery Ligation Devices and Methods
US8133242B1 (en) 2007-04-27 2012-03-13 Q-Tech Medical Incorporated Image-guided extraluminal occlusion
US20090157064A1 (en) * 2007-05-11 2009-06-18 Hodel Michael R RFID System and Method Therefor
US9486286B2 (en) 2007-05-14 2016-11-08 Boston Scientific Scimed, Inc. Medical laser user interface
US20090054916A1 (en) * 2007-08-23 2009-02-26 Peter Meier Clip-based method for treatment of uterine fibroids by obstruction of the uterine arteries
US20090054915A1 (en) * 2007-08-23 2009-02-26 Peter Meier Obstruction of uterine arteries to treat uterine fibroids using mechanical instruments to twist the vessels
US20090062827A1 (en) * 2007-08-31 2009-03-05 Peter Meier Vacuum-based method for obstruction of uterine arteries to treat uterine fibroids
US8490851B2 (en) 2008-01-15 2013-07-23 Covidien Lp Surgical stapling apparatus
US8864776B2 (en) * 2008-04-11 2014-10-21 Covidien Lp Deployment system for surgical suture
US8628545B2 (en) * 2008-06-13 2014-01-14 Covidien Lp Endoscopic stitching devices
US20110040308A1 (en) 2008-06-13 2011-02-17 Ramiro Cabrera Endoscopic Stitching Devices
USD708746S1 (en) 2009-06-10 2014-07-08 Covidien Lp Handle for surgical device
WO2011006067A1 (en) 2009-07-09 2011-01-13 Ams Research Corporation Apparatus and methods of treatment of pathologic proliferative conditions uterine tissue
US8403953B2 (en) * 2009-07-27 2013-03-26 Fibro Control, Inc. Balloon with rigid tube for occluding the uterine artery
US9554828B2 (en) * 2009-09-13 2017-01-31 Trig Medical Ltd. Birth delivery device with position sensor
US8490713B2 (en) * 2009-10-06 2013-07-23 Covidien Lp Handle assembly for endoscopic suturing device
US8211121B1 (en) 2010-03-06 2012-07-03 Q-Tech Medical Incorporated Methods and apparatus for image-guided extraluminal occlusion using clamping jaws
US10010345B2 (en) * 2010-04-07 2018-07-03 Miriam Mackovic Basic Instrument for occlusion of uterine blood vessels
GB201008109D0 (en) * 2010-05-15 2010-06-30 Young Peter Surgical forceps for wire introduction
US8968340B2 (en) 2011-02-23 2015-03-03 Covidien Lp Single actuating jaw flexible endolumenal stitching device
US9820793B1 (en) 2014-04-21 2017-11-21 Dallen Medical, Inc. Tensioning devices and methods for dynamic suture systems
US9468434B2 (en) 2014-06-03 2016-10-18 Covidien Lp Stitching end effector
US10092286B2 (en) 2015-05-27 2018-10-09 Covidien Lp Suturing loading unit
JP6653596B2 (en) * 2016-03-07 2020-02-26 テルモ株式会社 Medical device
US10542970B2 (en) 2016-05-31 2020-01-28 Covidien Lp Endoscopic stitching device
US11197665B2 (en) 2018-08-06 2021-12-14 Covidien Lp Needle reload device for use with endostitch device
CN112770680A (en) 2018-08-17 2021-05-07 安普列斯医疗公司 Device and method for compression of tumors
US11419610B2 (en) 2018-08-17 2022-08-23 Empress Medical, Inc. Device and method for passing tension member around tissue mass
CN111317525B (en) * 2020-02-28 2021-03-12 中南大学湘雅二医院 Skin suture forceps

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SU1072859A1 (en) * 1982-01-22 1984-02-15 Донецкий государственный медицинский институт им.А.М.Горького Intestinal forceps
WO1996005776A1 (en) * 1993-08-16 1996-02-29 Vesta Medical, Inc. Coagulating forceps
GB2302025A (en) * 1995-06-10 1997-01-08 Mark Steven Whiteley Vascular doppler forceps
DE20022012U1 (en) * 2000-04-18 2001-05-10 Hofstetter Alfons Medical clamp
US6254601B1 (en) * 1998-12-08 2001-07-03 Hysterx, Inc. Methods for occlusion of the uterine arteries
US20020183771A1 (en) * 2001-03-28 2002-12-05 Vascular Control Systems, Inc. Method and apparatus for the detection and ligation of uterine arteries

Family Cites Families (131)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3209753A (en) * 1962-05-04 1965-10-05 Donald B Hawkins Intestinal clamps and the like
US3411505A (en) 1965-12-15 1968-11-19 Paul D. Nobis Device for interrupting arterial flow
US3779248A (en) 1971-10-18 1973-12-18 Medical Concepts Inc Forceps
US3777740A (en) 1971-10-21 1973-12-11 Administrator For Veterans Aff Method and apparatus for non-invasively visualizing blood vessels
US4120302A (en) 1976-10-08 1978-10-17 American Hospital Supply Corporation Disposable pads for surgical instruments
US4428374A (en) * 1978-12-20 1984-01-31 Auburn Robert M Umbilical cord clamping assembly
US4292960A (en) 1979-04-30 1981-10-06 Rca Corporation Apparatus and method for application of radioactive and microwave energy to the body
US4226240A (en) 1979-05-30 1980-10-07 Walker Jr William E Surgical foreceps
US4509528A (en) 1981-12-16 1985-04-09 Harvinder Sahota Hemostat with blood flow sensor
US4428379A (en) 1982-01-07 1984-01-31 Technicare Corporation Passive ultrasound needle probe locator
US5370675A (en) 1992-08-12 1994-12-06 Vidamed, Inc. Medical probe device and method
US4650466A (en) 1985-11-01 1987-03-17 Angiobrade Partners Angioplasty device
US5037430A (en) 1986-01-06 1991-08-06 Hasson Harrith M Clamp for gynecological instruments
US4991588A (en) * 1986-07-21 1991-02-12 Pfizer Hospital Products Group, Inc. Doppler guide wire
US4757823A (en) 1987-01-27 1988-07-19 Hofmeister John F Method and apparatus for measuring uterine blood flow
US4994069A (en) 1988-11-02 1991-02-19 Target Therapeutics Vaso-occlusion coil and method
US4945896A (en) * 1989-01-24 1990-08-07 Gade George F Surgical retractor assembly having tissue viability sensor embedded therein
US5201314A (en) 1989-03-09 1993-04-13 Vance Products Incorporated Echogenic devices, material and method
US5081997A (en) 1989-03-09 1992-01-21 Vance Products Incorporated Echogenic devices, material and method
US5289831A (en) 1989-03-09 1994-03-01 Vance Products Incorporated Surface-treated stent, catheter, cannula, and the like
US5046503A (en) * 1989-04-26 1991-09-10 Advanced Cardiovascular Systems, Inc. Angioplasty autoperfusion catheter flow measurement method and apparatus
US5749879A (en) * 1989-08-16 1998-05-12 Medtronic, Inc. Device or apparatus for manipulating matter
US5108408A (en) 1990-04-20 1992-04-28 Lally James J Uterine-ring hysterectomy clamp
US5037433A (en) * 1990-05-17 1991-08-06 Wilk Peter J Endoscopic suturing device and related method and suture
US5100423A (en) 1990-08-21 1992-03-31 Medical Engineering & Development Institute, Inc. Ablation catheter
US5261409A (en) 1991-05-27 1993-11-16 Sulzer Brothers Limited Puncturing device for blood vessels
US5226911A (en) 1991-10-02 1993-07-13 Target Therapeutics Vasoocclusion coil with attached fibrous element(s)
US5662680A (en) 1991-10-18 1997-09-02 Desai; Ashvin H. Endoscopic surgical instrument
US5713896A (en) 1991-11-01 1998-02-03 Medical Scientific, Inc. Impedance feedback electrosurgical system
US5704361A (en) * 1991-11-08 1998-01-06 Mayo Foundation For Medical Education And Research Volumetric image ultrasound transducer underfluid catheter system
US5562680A (en) * 1992-01-03 1996-10-08 Hasson; Harrith M. Apparatus for assisting the performance of pelvic endoscopic procedures
JPH07506991A (en) 1992-04-23 1995-08-03 シメッド ライフ システムズ インコーポレイテッド Apparatus and method for sealing vascular punctures
US5443470A (en) 1992-05-01 1995-08-22 Vesta Medical, Inc. Method and apparatus for endometrial ablation
US5336231A (en) 1992-05-01 1994-08-09 Adair Edwin Lloyd Parallel channel fixation, repair and ligation suture device
NL9201118A (en) * 1992-06-24 1994-01-17 Leuven K U Res & Dev TOOL KIT FOR LAPAROSCOPIC VAGINAL HYSTERECTOMY.
US5672153A (en) 1992-08-12 1997-09-30 Vidamed, Inc. Medical probe device and method
WO1994006460A1 (en) 1992-09-21 1994-03-31 Vitaphore Corporation Embolization plugs for blood vessels
CA2102084A1 (en) 1992-11-09 1994-05-10 Howard C. Topel Surgical cutting instrument for coring tissue affixed thereto
US5275166A (en) 1992-11-16 1994-01-04 Ethicon, Inc. Method and apparatus for performing ultrasonic assisted surgical procedures
US5336229A (en) * 1993-02-09 1994-08-09 Laparomed Corporation Dual ligating and dividing apparatus
US5383922A (en) 1993-03-15 1995-01-24 Medtronic, Inc. RF lead fixation and implantable lead
CH688538A5 (en) * 1993-04-01 1997-11-14 Armin Bollinger Ultraschallortungsgeraet with Nadelfuehrung.
US5542944A (en) 1993-04-19 1996-08-06 Bhatta; Krishan M. Surgical device and method
GB9314640D0 (en) 1993-07-15 1993-08-25 Salim Aws S M Tunnellimg catheter
GB9314641D0 (en) 1993-07-15 1993-08-25 Salim Aws S M Tunnelling umbrella
US5582617A (en) 1993-07-21 1996-12-10 Charles H. Klieman Surgical instrument for endoscopic and general surgery
US5496331A (en) * 1993-07-28 1996-03-05 Terumo Kabushiki Kaisha Knot-forming instrument and method of forming knots
JP3313841B2 (en) 1993-09-24 2002-08-12 興和株式会社 Blood flow measurement device
JPH09507645A (en) 1994-01-18 1997-08-05 エンドバスキュラー・インコーポレイテッド Vein ligation device and vein ligation method
ATE157275T1 (en) 1994-03-07 1997-09-15 Maurer A Sa DEVICE FOR FILTRATION OF FLUID MEDIA
US5458596A (en) 1994-05-06 1995-10-17 Dorsal Orthopedic Corporation Method and apparatus for controlled contraction of soft tissue
US5707349A (en) 1994-05-09 1998-01-13 Somnus Medical Technologies, Inc. Method for treatment of air way obstructions
US5672172A (en) * 1994-06-23 1997-09-30 Vros Corporation Surgical instrument with ultrasound pulse generator
US5549624A (en) 1994-06-24 1996-08-27 Target Therapeutics, Inc. Fibered vasooclusion coils
US5591173A (en) * 1994-07-28 1997-01-07 Michael Schifano Schifano obstetric scissors
US5697942A (en) 1994-07-31 1997-12-16 Palti; Yoram Internal vascular clamp
US6032673A (en) 1994-10-13 2000-03-07 Femrx, Inc. Methods and devices for tissue removal
US5702407A (en) 1994-11-29 1997-12-30 Olympus Optical Co., Ltd. Ligating apparatus
US5588960A (en) 1994-12-01 1996-12-31 Vidamed, Inc. Transurethral needle delivery device with cystoscope and method for treatment of urinary incontinence
US5614204A (en) 1995-01-23 1997-03-25 The Regents Of The University Of California Angiographic vascular occlusion agents and a method for hemostatic occlusion
US6019724A (en) 1995-02-22 2000-02-01 Gronningsaeter; Aage Method for ultrasound guidance during clinical procedures
US5715832A (en) 1995-02-28 1998-02-10 Boston Scientific Corporation Deflectable biopsy catheter
US5665096A (en) * 1995-03-07 1997-09-09 Yoon; Inbae Needle driving apparatus and methods of suturing tissue
US5766135A (en) 1995-03-08 1998-06-16 Terwilliger; Richard A. Echogenic needle tip
US5817022A (en) 1995-03-28 1998-10-06 Sonometrics Corporation System for displaying a 2-D ultrasound image within a 3-D viewing environment
US5899861A (en) 1995-03-31 1999-05-04 Siemens Medical Systems, Inc. 3-dimensional volume by aggregating ultrasound fields of view
US5626607A (en) * 1995-04-03 1997-05-06 Heartport, Inc. Clamp assembly and method of use
US5570692A (en) 1995-05-19 1996-11-05 Hayashi Denki Co. Ltd. Ultrasonic doppler blood flow detector for hemorrhoid artery ligation
US5713371A (en) * 1995-07-07 1998-02-03 Sherman; Dani Method of monitoring cervical dilatation during labor, and ultrasound transducer particularly useful in such method
US5658299A (en) * 1995-07-20 1997-08-19 Applied Medical Resources Surgical ligating device and method for using same
DE19528440C2 (en) 1995-08-02 1998-09-10 Harald Dr Med Kuebler Surgical cutting instrument
US5674243A (en) 1995-08-03 1997-10-07 Hale; Theodore Mark Obstetrical forceps
US5979453A (en) 1995-11-09 1999-11-09 Femrx, Inc. Needle myolysis system for uterine fibriods
US5716389A (en) 1995-11-13 1998-02-10 Walinsky; Paul Cardiac ablation catheter arrangement with movable guidewire
DE19603981C2 (en) * 1996-02-05 1998-11-05 Wolf Gmbh Richard Medical instrument for uterine manipulation
CA2197614C (en) 1996-02-20 2002-07-02 Charles S. Taylor Surgical instruments and procedures for stabilizing the beating heart during coronary artery bypass graft surgery
US5697937A (en) 1996-02-23 1997-12-16 Toma; Doina Surgical clamp with manipulable guide means
AU733465B2 (en) 1996-03-05 2001-05-17 Tyco Healthcare Group, Lp Vascular catheter-based system for heating tissue
US5691314A (en) 1996-03-18 1997-11-25 The Medical College Of Hampton Roads Adjunctive therapy
DE19706751A1 (en) 1996-03-27 1997-10-02 Valleylab Inc Electrosurgical device for removing tissue in body areas
US6152874A (en) 1996-04-26 2000-11-28 Genzyme Corporation Adjustable multi-purpose coronary stabilizing retractor
US6077257A (en) 1996-05-06 2000-06-20 Vidacare, Inc. Ablation of rectal and other internal body structures
US6066139A (en) 1996-05-14 2000-05-23 Sherwood Services Ag Apparatus and method for sterilization and embolization
US5911691A (en) 1996-05-21 1999-06-15 Aloka Co., Ltd. Ultrasound image processing apparatus and method of forming and displaying ultrasound images by the apparatus
JPH09313487A (en) 1996-05-29 1997-12-09 Ge Yokogawa Medical Syst Ltd Method and device for ultrasonic three-dimensional photographing
US5720743A (en) 1996-06-07 1998-02-24 Bischof; John C. Thermally insulating surgical probe
US5776129A (en) 1996-06-12 1998-07-07 Ethicon Endo-Surgery, Inc. Endometrial ablation apparatus and method
US5904651A (en) * 1996-10-28 1999-05-18 Ep Technologies, Inc. Systems and methods for visualizing tissue during diagnostic or therapeutic procedures
CA2271205A1 (en) 1996-11-06 1998-05-14 Sts Biopolymers, Inc. Echogenic coating containing gaseous spaces for ultrasonography
US6106473A (en) 1996-11-06 2000-08-22 Sts Biopolymers, Inc. Echogenic coatings
US6035238A (en) 1997-08-13 2000-03-07 Surx, Inc. Noninvasive devices, methods, and systems for shrinking of tissues
US5797397A (en) 1996-11-25 1998-08-25 Hewlett-Packard Company Ultrasound imaging system and method using intensity highlighting to facilitate tissue differentiation
US5792059A (en) * 1996-11-26 1998-08-11 Esaote S.P.A. Intraoperative probe, specifically intended for direct-contact observations
US5895386A (en) 1996-12-20 1999-04-20 Electroscope, Inc. Bipolar coagulation apparatus and method for arthroscopy
US5759154A (en) 1996-12-23 1998-06-02 C. R. Bard, Inc. Print mask technique for echogenic enhancement of a medical device
US6579304B1 (en) 1997-02-03 2003-06-17 Applied Medical Resources Corporation Surgical clamp with improved traction
US5916173A (en) * 1997-02-26 1999-06-29 Kirsner; Vaclav Methods and apparatus for monitoring fertility status in the mammalian vagina
US6045508A (en) 1997-02-27 2000-04-04 Acuson Corporation Ultrasonic probe, system and method for two-dimensional imaging or three-dimensional reconstruction
US5947982A (en) * 1997-04-02 1999-09-07 Smith & Nephew, Inc. Suture-passing forceps
US5910484A (en) 1997-05-30 1999-06-08 The General Hospital Corporation Treatment of ischemic cardiac malfunction
US5895395A (en) * 1997-07-17 1999-04-20 Yeung; Teresa T. Partial to full thickness suture device & method for endoscopic surgeries
US5922008A (en) 1997-08-28 1999-07-13 Gimpelson; Richard J. Surgical forceps
US5941889A (en) 1997-10-14 1999-08-24 Civco Medical Instruments Inc. Multiple angle disposable needle guide system
US6015541A (en) 1997-11-03 2000-01-18 Micro Therapeutics, Inc. Radioactive embolizing compositions
US6280441B1 (en) 1997-12-15 2001-08-28 Sherwood Services Ag Apparatus and method for RF lesioning
CN1127752C (en) 1997-12-16 2003-11-12 皇家菲利浦电子有限公司 High-pressure discharge lamp
AU2318599A (en) * 1998-01-13 1999-08-02 Urometrics, Inc. Devices and methods for monitoring female arousal
EP1067872B1 (en) * 1998-03-20 2006-03-01 Boston Scientific Limited Endoscopic suture system
US6261234B1 (en) * 1998-05-07 2001-07-17 Diasonics Ultrasound, Inc. Method and apparatus for ultrasound imaging with biplane instrument guidance
JP3331177B2 (en) * 1998-07-29 2002-10-07 旭光学工業株式会社 Sector scan ultrasound probe
US5921933A (en) 1998-08-17 1999-07-13 Medtronic, Inc. Medical devices with echogenic coatings
US6786913B1 (en) * 1999-02-01 2004-09-07 Onux Medical, Inc. Surgical suturing instrument and method of use
US6425867B1 (en) * 1998-09-18 2002-07-30 University Of Washington Noise-free real time ultrasonic imaging of a treatment site undergoing high intensity focused ultrasound therapy
US5980534A (en) 1998-10-07 1999-11-09 Gimpelson; Richard J. Cervical clamp
US6013088A (en) * 1998-11-17 2000-01-11 Karavidas; Theocharis Surgical clamp with removable tips
US6231515B1 (en) 1999-01-13 2001-05-15 Scimed Life Systems, Inc. Safety mechanism and method to prevent rotating imaging guide device from exiting a catheter
US6080118A (en) * 1999-02-25 2000-06-27 Blythe; Cleveland Vaginal probe and method of using same
US6175751B1 (en) * 1999-03-16 2001-01-16 Allen Maizes Apparatus and method for sensing oxygen levels in a fetus
US6299621B1 (en) 1999-06-18 2001-10-09 Novare Surgical Systems, Inc. Surgical clamp pads with elastomer impregnated mesh
US6293954B1 (en) 1999-06-21 2001-09-25 Novare Surgical Systems, Inc. Surgical clamp with replaceable clamp members
US6125874A (en) * 1999-06-21 2000-10-03 Dril-Quip, Inc Gate valve having fail safe actuator
EP1072282A1 (en) 1999-07-19 2001-01-31 EndoArt S.A. Flow control device
US6210330B1 (en) * 1999-08-04 2001-04-03 Rontech Medical Ltd. Apparatus, system and method for real-time endovaginal sonography guidance of intra-uterine, cervical and tubal procedures
US6371973B1 (en) * 1999-08-04 2002-04-16 Ron-Tech Medical Ltd. Forceps useful for intrabody guiding and/or positioning of a medical instrument
US6610074B2 (en) * 2000-02-10 2003-08-26 Albert N. Santilli Aorta cross clamp assembly
US6676971B2 (en) 2000-03-13 2004-01-13 Biocure, Inc. Embolic compositions
US20030120306A1 (en) * 2000-04-21 2003-06-26 Vascular Control System Method and apparatus for the detection and occlusion of blood vessels
US6550482B1 (en) 2000-04-21 2003-04-22 Vascular Control Systems, Inc. Methods for non-permanent occlusion of a uterine artery
JP2001334120A (en) * 2000-05-25 2001-12-04 Nichias Corp Moisture absorbent and moisture absorption element using the same
US6355275B1 (en) 2000-06-23 2002-03-12 Carbon Medical Technologies, Inc. Embolization using carbon coated microparticles
US20030032898A1 (en) * 2001-05-29 2003-02-13 Inder Raj. S. Makin Method for aiming ultrasound for medical treatment

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SU1072859A1 (en) * 1982-01-22 1984-02-15 Донецкий государственный медицинский институт им.А.М.Горького Intestinal forceps
WO1996005776A1 (en) * 1993-08-16 1996-02-29 Vesta Medical, Inc. Coagulating forceps
GB2302025A (en) * 1995-06-10 1997-01-08 Mark Steven Whiteley Vascular doppler forceps
US6254601B1 (en) * 1998-12-08 2001-07-03 Hysterx, Inc. Methods for occlusion of the uterine arteries
DE20022012U1 (en) * 2000-04-18 2001-05-10 Hofstetter Alfons Medical clamp
US20020183771A1 (en) * 2001-03-28 2002-12-05 Vascular Control Systems, Inc. Method and apparatus for the detection and ligation of uterine arteries
US20020188306A1 (en) * 2001-03-28 2002-12-12 Burbank Fred H. Multi-axial uterine artery identification, characterization, and occlusion pivoting devices and methods

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP1489976A2 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1594407A2 (en) * 2003-02-05 2005-11-16 Vascular Control Systems, Inc. Vascular clamp for ceasarian section
EP1594407A4 (en) * 2003-02-05 2010-04-07 Vascular Control Systems Inc Vascular clamp for ceasarian section
JP2007521851A (en) * 2003-11-25 2007-08-09 バスキュラー・コントロール・システムズ・インコーポレイテッド Occlusion devices for asymmetric uterine artery structures

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