Treatment for post partum hemorrhage

Abstract

The invention is directed to instruments and procedures using such instruments for temporarily reducing or terminating blood flow through a female patient's uterine artery to treat post partum hemorrhage (PPH). The uterine artery is occluded by a clamping device which includes a pair of pivotally connected clamping members, with each of the clamping members having a handle and a clamping element at the distal end of the handle. The clamping elements are inclined with respect to the longitudinal axes of the handles at an included obtuse angle between about 120° and about 170°, preferably between about 130° and 160°. An artery locating sensor is provided on the distal end of at least one of the clamping elements. Preferably, the artery locating sensor is a Doppler ultrasound blood flow sensor. After birth, the clamping device is inserted into the female patient's post partum vaginal canal and advanced therein until one of the clamping elements Is in the patient's uterine cervix and the other clamping element is on the exterior of the uterine cervix. The clamping element on the exterior of the patient's uterine cervix is pressed against the patient's vaginal fornix and the clamping device closed so as to occlude the uterine artery disposed within tissue grasped by the clamping device. The clamping device is locked in the closed configuration and maintained in the condition until the patient's uterus is sufficiently clotted up to ensure termination of the hemorrhaging, typically about 5 minutes to about 7 hours.

1 . An intravaginal clamping device for occluding a female patient's uterine artery, comprising: 
 a. an first clamping means which has an elongated handle with a distal operative end, a proximal manipulative end and a first clamping element secured to the operative distal end of the first clamping means configured to engage the patient's vaginal fornix and which is at an obtuse angle with respect to the first handle;    b. a second clamping means which has a second elongated handle with a distal operative end, a proximal manipulative end and a second clamping element secured to the operative distal end of the second elongated handle which is configured to enter the patient's uterine cervix when the first clamping element engages the patient's vaginal fornix at essentially the same obtuse angle with respect to the second elongated handle that the first clamping element is with respect to the first elongated handle;    c. a pivotal connecting means between the first and second clamping means so that rotation of the first and second handles about the pivotal connection within a plane of rotation adjusts spacing between the first and second clamping elements; and    d. the first and second clamping elements being angled with respect to the first and second handles respectively so that the first and second clamping elements extend away from the plane of rotation.    
   
   
       2 - 3 . (canceled)  
   
   
       4 . The intravaginal clamping device of claim  2  wherein the second clamping element is larger than the first clamping element.  
   
   
       5 . The intravaginal clamping device of claim  2  wherein the second clamping element is longer than the first clamping element.  
   
   
       6 . The intravaginal clamping device of  claim 1  wherein the first and second clamping elements are paddle-shaped.  
   
   
       7 . The intravaginal clamping device of  claim 6  wherein the paddle-shaped clamping elements are formed of wire frames  
   
   
       8 . The intravaginal clamping device of  claim 1  wherein the clamping elements are curved.  
   
   
       9 . The intravaginal clamping device of  claim 1 , wherein the first and second clamping elements are releasably secured to the first and second handles.  
   
   
       10 . The intravaginal clamping device of  claim 1 , wherein an artery location sensor is secured to a distal portion of at least the second clamping element.  
   
   
       11 . The intravaginal clamping device of  claim 10 , wherein the artery location sensor is selected from the group consisting of blood flow sensors, sound sensors, ultrasound sensors, pressure sensors, pulsation sensors, stress sensors, strain sensors, chemical sensors, electromagnetic radiation sensors, and combinations thereof.  
   
   
       12 . The intravaginal clamping device of  claim 7 , wherein the artery location sensor is a Doppler ultrasound sensor.  
   
   
       13 . The intravaginal clamping device of  claim 8 , wherein the Doppler ultrasound sensor is configured to sense ultrasound energy having a frequency of between about 5 MHz and about 20 MHz.  
   
   
       14 . The intravaginal clamping device of  claim 8 , wherein the Doppler ultrasound sensor is configured to sense ultrasound energy having a frequency of between about 6 MHz and about 10 MHz.  
   
   
       15 . The intravaginal clamping device of  claim 1 , wherein the clamping elements have lengths between about 0.8 inch and about 6 inches.  
   
   
       16 . The intravaginal clamping device of  claim 1 , wherein the clamping have lengths between about 2.5 inches and about 4.5 inches.  
   
   
       17 . The intravaginal clamping device of  claim 1 , wherein a distal end of the second clamping element is disposed distal to a distal end of the first clamping element.  
   
   
       18 . The intravaginal clamping device of  claim 17  wherein the distal end of the second clamping element is disposed distal to the distal end of the first clamping element by a distance of about 0.1 inch to about 2 inches.  
   
   
       19 . The intravaginal clamping device of  claim 17 , wherein the distal end of the second clamping element is disposed distal to the distal end of the first clamping element by a distance of about 0.1 inch to about 1 inch.  
   
   
       20 . The intravaginal clamping device of  claim 1 , wherein the clamping elements have a width of about 0.5 inch to about 3 inches.  
   
   
       21 . The clamping device of  claim 1 , wherein the clamping element has a loop-shaped wire frame.  
   
   
       22 . The intravaginal clamping device of  claim 1 , wherein the clamping elements have pressure-applying surfaces.  
   
   
       23 . (canceled)  
   
   
       24 . The intravaginal clamping device of  claim 1 , wherein the handles have an interconnecting locking mechanism which provide a locked configuration effective to retain the clamping elements in a pressure-applying configuration.  
   
   
       25 . A system for occluding a patient's blood vessel, comprising: 
 a) a clamping device for occluding a patient's artery which has 
 i. an first clamping member which has a first elongated handle with a distal operative end, a proximal manipulative end and a first clamping element secured to the operative distal end configured to engage the patient's vaginal fornix and at an obtuse angle with respect to the first handle,  
 ii. a second clamping member which has a second elongated handle with a distal operative end and a proximal manipulative end and a second clamping element secured to the operative distal end of the second elongated handle configured to enter the patient's uterine cervix and is at an obtuse angle with respect to the second elongated handle,  
 iii. a pivotal connection between the first and second clamping members so that rotation of the first and second handles about the pivotal connection within a plane of rotation adjusts spacing between the first and second clamping elements, and  
 iv. the first and second clamping elements being angled with respect to the first and second handles respectively so that the first and second clamping elements extend away from the plane of rotation;  
   b. a artery location sensor secured to a distal portion of a clamping element; and    c. an elongated signal transmitting member having a proximal end and a distal end and being secured at its distal end to the artery locating sensor and having a connector on its proximal end configured to be connected to a sensor controller.    
   
   
       26 . The system of  claim 25 , wherein the artery location sensor is a Doppler ultrasound sensor.  
   
   
       27 . The system of  claim 25  wherein the handles have a locking mechanism to provide a locked configuration effective to retain the clamping members in a pressure-applying configuration.  
   
   
       28 - 39 . (canceled)  
   
   
       40 . The intravaginal clamping device of  claim 1 , wherein the pressure applying surfaces of the clamping elements are configured to apply pressure along the paddle shaped elements.