JP4455581B2 - Uterine artery occlusion clamp - Google Patents

Description

  The present invention is generally directed to treating uterine defects by detecting and adjusting blood flow through the uterine artery of one or both patients.

  Hysterectomy (surgical removal of the uterus) is performed on about 600,000 women annually in the United States. Hysterectomy is often known as uterine cancer, adenomasis, menorrhagia, uterine prolapse, dysfunctional uterine bleeding (abnormal menstrual bleeding without a separate anatomical explanation such as tumor or growth), and Remyoma or hysteromyoma Is one of the therapeutic choices for the treatment of uterine muscle tumors.

  However, hysterectomy is an intense treatment with many undesirable features. Thus, any method that can approximate the therapeutic outcome of a hysterectomy without removing the uterus is a significant improvement in the field. Newer therapies have been developed for certain illnesses, where hysterectomy can be omitted for women.

  In 1995, a technique was disclosed in which uterine fibroids were treated without removal of the uterus using non-surgical treatment, and in particular included a technique involving reciprocal internal luminescent occlusion of uterine arteries (Rabin et al., “Uterine fibroids). Arterial Embolization for Treatment ", Lancet, September 9, 1995; Vol. 346; pp. 671-672, entirely combined here). This technique is known as “uterine artery embolization”. In this technique, the uterine artery is approached via the transition route from the normal femoral artery to the left and right uterine arteries by means of an intraluminal catheter, and a small metal coil, polyvinyl alcohol particles, and the like. A plug material is delivered through the catheter into the uterine artery, which causes rapid occlusion.

  The uterus receives a double (or extra) blood supply, ie the primary blood supply is from both uterine arteries and the secondary blood supply is from both ovarian arteries. As a result, if both uterine arteries are occluded, i.e., both blood vessels are occluded, both the uterus and the fibroids held in the uterus are deprived of their blood supply. However, as described by Rabina et al., The effect on uterine fibroids is greater than the effect on the uterus. In most instances, the fibroids are deflated and clinical signs stop.

  However, many physicians do not have the techniques or instruments necessary to perform catheter-based uterine arterial emboli under radiation instructions. Thus, substantially fewer uterine artery emboli are performed annually worldwide, which is less than hysterectomy for symptomatic uterine fibroids.

  Recently, a treatment procedure for uterine fibroids has been described in which the uterine artery is temporarily occluded by an intraluminal device that is non-invasively pressed against the patient's vaginal cap and the patient's uterine artery is Pressure is applied to the visceral tissue bundle by a clamp or other method. The uterine artery under pressure on the tissue is occluded. Although these procedures have shown many hopes, in many situations the instruments described so far have not always allowed the correct placement of the clamping surface.

  What is needed, therefore, is an instrument and method for sensing blood vessels and blood flow within blood vessels, and an instrument and method for occluding blood flow within blood vessels such as uterine arteries, which is not It can be used within a simple medical facility or environment by the physician having it.

  The present invention is directed to relatively non-invasive uterine artery occlusion devices and systems and methods of using the devices and systems for uterine artery occlusion in female patients. The devices and their use can be utilized by reducing or stopping blood flow through the patient's uterine artery to treat uterine fibroids, dysfunctional uterine bleeding, postpartum hemorrhage and other uterine defects.

  An instrument embodying features of the present invention includes an intrauterine clamp, which includes a pressure application or clamping member so that pressure can be applied to the outside of the patient's cervix or to the patient's vaginal vault. It is configured. The intravaginal clamp also includes a stabilizing or positioning member that is inserted into the patient's cervix to stabilize at least the position inside the cervix and is effective against the outside of the cervix or vaginal vault by the pressure application member. This is to facilitate effective pressure application and ensure effective occlusion of the patient's uterine artery. Uterine artery occlusion is temporary and may be partial or complete.

  One method of vascular occlusion involves clamping the blood vessel to reduce or eliminate blood flow through the blood vessel. Such vascular clamps can be direct or indirect. Preferably, effective compressible vascular clamping is achieved by applying a non-invasive vaso-occlusive device to tissue in the vicinity of the blood vessel (eg, on the tissue surrounding the blood vessel). The vaso-occlusive device can also be applied directly on the blood vessel to effectively compress the blood vessel.

  In one embodiment of the invention, a non-invasive vaso-occlusive device (such as a sensored clamp) may be applied to a portion of the vaginal wall to detect and / or locate and occlude the uterine artery. . A vaginal clamp embodying features of the present invention can be used to sense the location of the uterine artery near the vaginal wall and compress and occlude the uterine artery near the vaginal wall. The vaginal wall can be expanded with an occlusive device so that it is more accessible to the uterine artery; such access can be aided by applying pressure or force to the uterus (eg, pulling on the cervix) By). The cervix is grabbed or pulled by any suitable instrument or tool, which includes forceps, suction instruments, and other tools such as support rods.

  The non-invasive vaso-occlusive device embodying features of the present invention may be a non-invasive intravaginal uterine artery occlusion device, a pair of pressure applying members having opposing tissue contacting surfaces at their distal ends; At least one support shaft extending from a proximal end of one pressure application member, the support shaft configured to adjust a distance between opposing tissue contact surfaces of the pressure application member; and the opposite tissue contact surface At least one blood flow sensor on one of the two. Examples of non-invasive vaso-occlusive devices embodying features of the present invention include, for example, a handle, a clamp member configured to apply pressure or force to body tissue, and to locate a vessel Can be equipped with sensors.

  The pressure application member, such as a clamp member, can be a jaw or a plurality of jaws configured to engage a blood vessel or tissue in the vicinity of the blood vessel, for example. A support shaft, such as a handle, is preferably configured to operate the jaw or jaws. In one embodiment of the device having features of the present invention, the pressure application member is attached to the connecting portion and the jaw is placed in the vagina while the handle remains outside the patient's body and is usable by the operator. Can be configured as follows.

  The clamping member preferably comprises a blood flow sensor for searching for blood vessels to be occluded. The sensor detects sound, pressure, strain, stress, chemical values, electromagnetic radiation and the like, and may be a combination of such sensors. The sensor is preferably a Doppler ultrasonic sensor. The sensor is mounted against the tissue contacting surface of the clamp member, such as the face of the clamp jaw, and is preferably oriented perpendicular to the clamp surface, although other orientations can be employed. Ultrasonic energy useful for position sensing of blood vessels or blood flow within blood vessels has a frequency of less than about 20 megahertz (MHz) and is between about 5 MHz and about 19 MHz, preferably between about 6 MHz and 10 MHz. In commercially available Doppler sensors, the frequency is typically about 8 MHz. For sensors based on electromagnetic energy useful for position detection of blood vessels or blood flow in blood vessels, the wavelength that the EM energy should comprise is between about 500 nanometers (nm) and about 2000 nm, preferably about 700 nm to Between about 1000 nm.

  A system embodying features of the present invention includes a vascular occlusion device as described above with a blood flow sensor on a clamp member for target vessel search, and a sensor controller that may include an energy source for the sensor. The sensor controller can be configured to help detect the position of the blood vessel, for example by providing a signal regarding the sensor output that can be easily used by an operator. The sensor controller may comprise an energy source configured to provide energy for blood flow sensor operation.

  A method for uterine artery occlusion embodying features of the present invention includes advancing a clamping device through a patient's vaginal conduit and moving the clamping member's stabilizing member through the cervix and into the cervical conduit. The pressure application surface of the clamp member is pressed into the vaginal vault of the patient. Adjustment of the clamp member allows a sensor on its end to allow the uterine artery to be close to the face of the vaginal fornix. With the clamping member approaching the target vessel, the clamping device can be closed to compress the underlying tissue and thereby occlude the uterine artery. The uterine artery is placed beside the blood flow sensor on the end of the clamp member. Tension is applied to the cervix with a grasping tool (eg, by pulling the cervix), which is done while applying force or pressure to the vaginal wall for uterine artery occlusion.

  The present invention allows non-invasive search and occlusion of blood vessels such as uterine arteries and provides an effective treatment method. Importantly, the present invention allows occlusion of the uterine artery of a female patient without the need for radiological tools or extensive radiographic techniques. This device and method is simpler and easier to use and remove than other methods and devices, and can be used for uterine fibroids, dysfunctional uterine bleeding (DUB), adenomysis, postpartum hemorrhage, and other uterine disorders. It can also be used easily. Devices, systems and methods embodying features of the present invention allow separate occlusion of individual uterine arteries, such that the uterine anatomy does not allow the use of a single reciprocal arterial occlusion device. Provide effective treatment in any situation.

  These and other advantages will be apparent from the accompanying drawings and from the detailed description that follows below.

  1 and 2 illustrate a relatively non-invasive intrauterine obstruction clamp 10 that embodies features of the present invention. The clamp 10 includes a clamp member 11 having an elongated handle 12 with a finger grip 13 and a pressure applying clamp element or jaw 14 on the end of the clamp member. The intrauterine clamp also includes a stabilizing member 15 that is configured to easily follow or follow the patient's cervix and cervical passage. The stabilizing member 15 includes an extension handle 16 with a finger grip 17. The clamping member 11 and the stabilizing member 15 are pivotally attached to each other at a pivot point 18, and preferably the rotation of the handles 12 and 16 by the operator's fingers engaged through the grips 13 and 17, respectively, is the jaw 14 and the stabilizing member. Adjust the spacing between the 15 end portions. Each handle 12 and 16 includes a ratchet member 19 and 20, respectively, which interact to lock the relative positions of the clamp member 11 and the stabilization member 15.

  A uterine artery clamp embodying features of the present invention preferably includes a blood flow sensor 22, preferably a Doppler ultrasound sensing system, on the distal face of the jaw 14. This sensor position allows the operator to more easily guide the jaw 14 to the patient's target uterine artery position. The sensor 22 includes a signal transmission cable 23 that is operably connected to a sensor control instrument 24. The cable 23 is a coated wire, multiple wires, optical fibers, wave guides, or other connections that can effectively carry signals and / or energy or power between the sensor 22 and the sensor controller 24.

  The sensor 22 is a blood flow sensor for searching blood vessels, and is a passive sensor, and can be configured to detect a unique signal indicating the presence of a blood vessel (ie, a sound sensor, a motion sensor, a pH sensor, Or physical, chemical, electrical, or physiological indication of blood vessel location). In other embodiments, the blood flow sensor for searching for blood vessels is an active sensor, configured to emit energy or signal, and corresponding to or derived from radiant energy or signal indicative of the presence of a blood vessel. An ultrasound source having an ultrasound sensor configured to detect a signal (ie, configured to detect reflected ultrasound from a blood vessel, configured to detect reflection from the blood vessel An infrared radiation source or other energy source or sensor configured to detect reflections indicating the location of a blood vessel). Sensor operation may be aided by an energy source such as sensor controller 24. For example, the energy source comprises electrical energy, which helps the ultrasonic sensor to produce and detect ultrasonic energy (Medasonics® Cardeobeat® Blood Flow Doppler with Integrated Speaker ( Such as Cooper Surgical, Trumble CT 06611). Other commercially available Doppler ultrasound sensors suitable for use in the present invention are Coven Model ES 100X Mini-Dop VRP-8 probe (St. Louis, MO) and DWL / Neuro Scan Medical Systems Multi-Dop B + System (Sterling, VA). )including.

  As shown in FIG. 3, the jaw 14 includes a serrated, tissue-gripping surface 25 that engages the tissue and is tissue top when the jaw 14 is pushed into the tissue of the patient's vaginal cap. Is configured to hold. As shown in FIG. 4, one or both of jaw 14 and / or stabilizer 15 may be provided with retractable fingers or teeth 26 to better secure the contact member to the target tissue.

  FIG. 5 illustrates another embodiment in which the clamping member 11 and the stabilizing member 15 are inclined with respect to the handles 12 and 16 by an angle θ. This angled portion provides a more direct attack angle that facilitates the insertion of the stabilizing member 15 into the patient's cervix and the orientation of the jaw 14 to the desired location on the patient's vaginal fornix to provide the patient's uterus Facilitates arterial exploration and occlusion. A suitable angle θ of the jaw 14 and the stabilizer 15 is about 100 ° to about 175 °, preferably about 130 ° to about 160 °.

  Vascular occlusion, which may be partial or complete, is performed by application of pressure through the wall of the patient's vaginal cap. Sufficient pressure or force supplied to at least partially compress the tissue of the vaginal wall occludes the underlying uterine artery. A blood flow sensor for detecting or probing the uterine artery should be placed on the distal surface away from the clamping element and generally perpendicular to the effective tissue contacting surface of the jaw 14.

  A non-invasive vaso-occlusive device embodying features of the present invention may be configured to lock in a clamping position. Such a locked structure can be temporary or releasable, or permanent. A non-invasive vaso-occlusive device embodying features of the present invention includes a locking mechanism such as a ratchet, which is configured to hold at least one pressure application member in a pressure application position. Such a locking mechanism may include a release mechanism that is effective to allow the pressure or force to stop when desired. In this way, a non-invasive vaso-occlusive device embodying features of the present invention is a lock effective to relieve vascular occlusion by stopping the application of pressure or force previously supplied for vascular occlusion. It can be configured to release the mechanism.

  The female uterine artery is located in the vicinity of the vaginal mucosa within a few centimeters (cm) of the vaginal fornix. As a result, the size of the vagina determines the preferred size of the clamping device to access and occlude the uterine artery from within the patient's vaginal conduit, which facilitates the clamping device to the vaginal fornix And can be operated from outside the patient's body. For example, the clamping device can be between about 5 and about 16 inches in length for most applications, preferably between about 6 inches and about 12 inches.

  FIG. 6 is a schematic diagram partially illustrating the female reproductive system, including the uterus 30, cervix 31, uterine artery 32, vaginal conduit 33, and vaginal cap 34. A method of using a uterine artery clamp embodying features of the present invention inserts the clamp 10 into the patient's vaginal conduit 33 and advances the clamp therein until the distal portion of the clamp reaches the vicinity of the patient's cervix 31. . The positions of the handles 12 and 16 are adjusted so that the spacing between the jaw 14 and the end portion of the stabilizer 16 is increased. The end of the stabilizer is guided through the cervix 35 into the cervix. The end of the jaw 14 is pressed against the vaginal lids 34 and 14. Guided by the Doppler sensor 22, the jaw pressure application surface is positioned as close as possible to the patient's uterine artery 32. Sufficient pressure is applied by the jaw 14 to the uterine artery 32 or tissue surrounding the uterine artery to facilitate occlusion of the uterine artery. Handles 12 and 16 are locked by ratchet members 19 and 20 to press jaw 14 against the tissue between jaw 14 and stabilizer 15. The clamped portion is for about 0.5 to about 48 hours, preferably about 1 to about 24 hours, for effective medical treatment for uterine upset, eg, fibroids, PPH, DUB and the like Retained. The blood flow sensor 22 is effective for searching the uterine artery by detecting blood flow and monitoring treatment by detecting insufficient blood flow in the artery. Blood flow in the left uterine artery 50 can be similarly occluded by another uterine artery clamp of the same structure, or the same clamp can be used on the other side after deocclusion of the right uterine artery 34.

  The ratchet members 19 and 20 are preferably releasable so that the clamp member 11 of the clamp device 10 can be released after a predetermined treatment time to allow resumption of blood flow to the uterine artery.

  FIGS. 7 and 8 illustrate another clamping structure in which the spacing between the jaw 14 and the stabilizer 15 is as shown in FIG. 8 and the spring 40 as shown in FIG. The rack and pinion mechanism 50 can be controlled. Various other means may be employed for opening and closing the jaw 14 and the stabilizer 15.

  Uterine artery clamp 10 embodying features of the present invention can be made of any suitable material or combination of materials, such as a metal such as stainless steel and a nickel titanium alloy having a suitable austenitic phase at body temperature. Superelastic shape memory alloys, high strength plastics, ceramics, and other materials known in the art. Biocompatible polymers such as polycarbonates, polysulfones, polyesters, polyacetals and various fluoropolymers are suitable for variations of the examples of the present invention. The instrument or system can be single use (can be discarded) or sterilized for multiple use.

  While particular forms of the invention have been illustrated and described, it will be apparent that various modifications can be made. Thus, individual features shown in one embodiment may be combined with any or all of the other embodiments described herein. Accordingly, it is not intended that the invention be limited to the specific embodiments described. Accordingly, the invention is as broad as the prior art allows and should be limited by the scope of the appended claims. “Element”, “Member”, “Instrument”, “Sections”, “Part”, “Section”, “Process” and similar terms used herein are described in Article 35U. S. C. Should not be construed as in accordance with § 112 (6), where the following claims have the term “means” or “step” followed by the specific function without a specific structure or operation It is other than.

It is a front view in the open state of the uterine-artery clamp instrument which actualized the characteristic of this invention. FIG. 2 is a perspective view of the clamping device shown in FIG. 1. FIG. 6 is an enlarged perspective view of the distal portion of another clamping device with a sawtooth surface and a plurality of teeth for grasping tissue. In an enlarged perspective view of another clamping device, the clamping element and the stabilizer element comprise teeth for grasping tissue. FIG. 3 is a schematic view of an inner uterine clamp in a female patient uterine artery occlusion position. In a perspective view of another embodiment, the clamping element and the stabilizer element are tilted with respect to the handle of the clamp. In a perspective view of an alternative embodiment, the spacing between the stabilizing member and the clamp member is adjusted by a spring coil. In a perspective view of an alternative embodiment, the spacing between the stabilizing member and the clamp member is adjusted by a rack and pinion structure.

Claims (8)

An intrauterine clamping device for uterine artery occlusion in a female patient ,
a. A clamping member having a distal end of a first clamping element configured to fit around an outer portion of the patient's cervix and having a paddle shape;
b. A stabilizing member having a second clamping element that is a rod-shaped element having a distal portion configured to extend within the patient's cervix and at least partially composed of a wire frame;
c. A connector provided between the clamp member and the stabilization member so as to adjust a distance between the clamp member and the stabilization member;
d. A blood flow sensor provided at the end of the second clamping element,
i) introducing the intrauterine clamp device into the patient's vaginal canal until the first clamp element is placed in the cervix and the second clamp element is placed outside the cervix; Advancing the intrauterine clamping device;
ii) the intrauterine clamping device is further advanced in the patient's vaginal canal and the pressure application surface of the second clamping element is pressed against the area of the patient's vaginal foramen so that the tissue of the vaginal foramen is the underlying uterine tissue Folding on top of the
iii) detecting blood flow through the patient's uterine artery to ensure that the pressure application surface of the second clamp element is positioned over the patient's uterine artery;
iv) at least partially occluding the uterine artery by pressing together the clamping member and the stabilizing member of the instrument to close at least the second clamping element against the patient's vaginal fornix and underlying uterine tissue; ,
An intrauterine clamping device , characterized in that it is configured to perform: 2. The first clamping means and the second clamping means are locked in a closed configuration in which the first clamping element and the second clamping element at least partially occlude the uterine artery. Intrauterine clamping device. The intrauterine clamp device according to claim 1, wherein the blood flow sensor is a Doppler ultrasonic sensor. 4. The intrauterine clamping device of claim 3, wherein the Doppler ultrasonic sensor emits ultrasonic waves having a frequency of about 5 MHz to about 20 MHz toward the uterine artery. The intrauterine clamping device according to claim 3, wherein the Doppler ultrasonic sensor detects a change in blood flow in a blood vessel. 6. The intrauterine clamping device according to claim 5, wherein the Doppler ultrasonic sensor detects a decrease in blood flow in a blood vessel. End of the clamp member, said characterized in that it is arranged only on the distal side a distance of about 0.254cm to about 2.54cm relative to ends of the stabilizing member, intrauterine clamp according to claim 1 Instruments. It said clamp member, characterized in that it comprises a width of about 1.27cm to about 7.62 cm, intrauterine clamping device according to claim 1.

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