This invention relates to a device for controlling post-partum hemorrhage, and more particularly, to a tamponade device for controlling uterine and vaginal post-partum hemorrhage.
Postpartum hemorrhage is most commonly caused by uterine atony whereby the uterus fails to contract normally after the delivery of a baby. This condition occurs in about 5 percent of deliveries. Hemorrhage continues to be one of the major causes of maternal deaths generally, with obstetrical hemorrhage being the third leading cause of maternal death by hemorrhage in the United States. Worldwide, maternal hemorrhage qualifies as the leading cause of maternal death.
Techniques for managing obstetrical hemorrhage may be medical, mechanical, or surgical. Hysterectomy, while an effective surgical procedure for treating this condition, bears severe consequences, in particular for young women who have not completed childbearing.
One of the mechanical procedures often used for managing obstetrical hemorrhage involves packing the uterus with heavy gauze. This procedure remains controversial because of a high failure rate, and is considered a waste of time by some medical practitioners. The high failure rate is attributable to the inherent difficulty in packing the uterus properly so that there is an even distribution of pressure along the entire inner surface of the organ.
Accordingly, a more effective procedure is needed to address post-partum hemorrhage and bleeding. Ideally, the procedure should present minimal long-term health consequences to the patient, be quickly and easily accomplished, be easily learned and require no specialized instrumentation.
U.S. Pat. No. 4,619,261 issued on Jun. 17, 1980 to Guerriero, discloses a hydrostatic pressure application device for controlling bleeding from an internal wound. The device of Guerriero comprises a balloon captured within a net. The net is secured to an area surrounding a wound with surgical sutures, so that hydraulic pressure applied to the balloon expands the balloon and causes pressure to be applied at the wound. Pressure so applied at the wound causes a cessation in bleeding. Disadvantageously, however, because the device is sutured to an area surrounding the wound, applying and removing the device of Guerriero requires an operative (surgical) procedure.
U.S. Pat. No. 4,207,891 issued on Jun. 17, 1980 to Bolduc, discloses a fluid dispensing instrument having a dispenser that operates to place a drug material into a uterine cavity, and an expandable balloon that operates to move the drug material from the uterine cavity into both canals of the Fallopian tubes. However, the dispensing instrument of Bolduc is not configured and operated in a manner directed to the control of post-partum hemorrhage and bleeding.
U.S. patent application Ser. No. US2001/0007945 published on Jul. 12, 2001 to Piraka discloses a uterine balloon for controlling hemorrhaging in a patient after childbirth. The balloon of Piraka is filled with a physiologic solution by means of a catheter inserted through a valve in the balloon. A fill system, a control system, and a pressure relief valve are each employed for maintaining a constant solution pressure in the balloon. However, no means are disclosed for determining whether bleeding has been effectively stopped, in order to adapt balloon pressure accordingly.
None of the above-described devices provide the full advantage of the novel device and method described herein.
A novel device and method are disclosed for controlling uterine and vaginal post-partum hemorrhage.
The present invention comprises a tamponade device having an inflatable balloon whose shape, when inflated, takes on the shape of the site to be controlled (for example, the shape of a uterine wall). The device also comprises an internal drain tube coaxially and sealably positioned with respect to the balloon, and having a port at an inserted end for draining blood and other fluids from the uterine cavity. An insufflation tube feeds a distending medium (such as air or a physiologic fluid) through a supply tube to inflate the balloon. The supply tube co-axially encircles the drain tube to define a thin passageway between an inner surface of the supply tube and an outer surface of the drain tube. Perforations in the supply tube allow the medium to pass from this passageway in order to distend the balloon.
With sufficient inflation pressure, the balloon exerts a uniform distribution of compressive pressure, which in turn controls bleeding sites. This control of bleeding gives the uterus time to respond normally as bleeding stops, and conserves blood while preparing the patient for surgery as necessary. This device may also be utilized in the vagina to control bleeding associated with submucosal tears (tears under the mucosal vaginal lining), and with any continuous bleeding resulting in the subsequent development of hematomas. Accordingly, significant blood loss, pain, and the possibility of an operative procedure may be prevented. In a preferred embodiment of the present invention, an outer surface of the balloon is coated or impregnated with a hemostatic material for contact with the uterine wall or vaginal lining to provide additional control of bleeding.
An advantage provided by the present invention is that its insertion, inflation, and removal require no surgical procedures, and very little time. The device is thus uniquely and admirably suitable for use in uterine hemorrhaging emergencies. Other presently known devices which use expandable material to stop abdominal bleeding during or after surgery are considerably more complicated in construction and much more difficult to use, often requiring surgical application and removal.
USPTO Backgrounds
USPTO Backgrounds