Treatment for post partum hemorrhage

• US 7,404,821 B2
• Filed: 01/30/2003
• Issued: 07/29/2008
• Est. Priority Date: 01/30/2003
• Status: Expired due to Term

• Current Assignee: Vascular Control Systems, Inc. (Johnson & Johnson)
• Original Assignee: Vascular Control Systems, Inc. (Johnson & Johnson)
• Inventors: Jones, Michael L., Burbank, Fred H., Uyeno, Jill
• Primary Examiner(s): Erezo; Darwin P
• Application Number:
  US10/355,809
• Publication Number:
  US 20040153097A1
• Time in Patent Office: 2,007 Days
• Field of Search: 606/119, 606205-208, 606/210, 606/211, 600/504, 600/424
• US Class Current: 606/205
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/2812 with a single pivotal connection A61B17/29 takes precedence
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 2017/00057 Light
• CPC Class Codes: A61B 2017/2837 with a locking ratchet
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/378 using ultrasound

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.

Claims

1. A method of treating a female patient suffering from PPH, comprising:

a. providing an intravaginal clamping device having

i. a first clamping member which has an elongated handle with a distal operative end and a proximal manipulative end and a clamping element secured to the operative distal end 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 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 within a rotational plane about the pivotal connection adjusts spacing between the first and second clamping elements with the clamping elements extending out of the rotational plane of the first and second handles; and

iv. a blood flow sensor on a pressure applying surface on the distal end of the second clamping element;

b. introducing the intravaginal clamping device into the patient'"'"'s vaginal canal, and advancing the device therein until the first clamping element of the device is disposed within the patient'"'"'s uterine cervix and the second clamping element of the device is disposed on the exterior of the patients uterine cervix;

c. further advancing the device within the patient'"'"'s vaginal canal to press the pressure applying surface of the second clamping element against a region of the patient'"'"'s vaginal fornix to fold the tissue of the vaginal fornix over underlying uterine tissue;

d. detecting blood flow through the patient'"'"'s uterine artery to ensure that the pressure applying surface of the second clamping element is located over the patient'"'"'s uterine artery; and

e. compressing the handles of the device together to close at least the second clamping element against the patient'"'"'s vaginal fornix and underlying uterine tissue to at least partially occlude the uterine artery.

2. The method of claim 1, wherein the first and second clamping members are locked in a closed configuration in which the clamping elements at least partially occlude a uterine artery of the patient.

3. The method of claim 1, wherein the blood flow sensor is a Doppler ultrasound sensor.

4. The method of claim 3, wherein the Doppler ultrasound sensor emits ultrasound toward the uterine artery having a frequency of between about 5 MHz and about 20 MHz.

5. The method of claim 3, wherein the Doppler ultrasound sensor detects a change in blood flow in the blood vessel.

6. The method of claim 5, wherein the Doppler ultrasound sensor detects a reduction in blood flow in the blood vessel.

7. The method of claim 1, wherein the clamping members apply a pressure of between about 3 psi and about 80 psi.

8. The method of claim 1, wherein the clamping members apply a pressure of between about 5 psi and about 30 psi.

9. The method of claim 1, wherein the uterine artery is at least partially occluded for a period less than 24 hours.

10. The method of claim 1, wherein the uterine artery is at least partially occluded for a period comprising between about 5 minutes and about 7 hours.

11. The method of claim 1, wherein the uterine artery is at least partially occluded for a period comprising between about 10 minutes and about 5 hours.