US-12616503-B2 - Methods for postpartum uterine hemostasis

US12616503B2US 12616503 B2US12616503 B2US 12616503B2US-12616503-B2

Abstract

A method of uterine hemostasis involves inserting a suction line of a postpartum hemorrhage mitigation device through a cesarian incision into the uterine cavity, guiding the suction line through the cervix and into the vagina, positioning an anchoring mechanism of the device adjacent the internal cervical OS of the uterine cavity, closing the cesarian incision to enclose the suction line within the uterine cavity, and connecting the suction line to a negative pressure source that introduces negative pressure to the uterine cavity via the suction line, thereby causing contraction of the uterus and evacuation of fluid from the uterus via the suction line extension. Upon completion of a treatment period, the negative pressure source is disconnected, and the suction line and anchoring mechanism are extracted from the uterus through the cervical canal and the vagina.

Inventors

Jennifer Rae West

Assignees

ALC MEDICAL HOLDINGS LLC

Dates

Publication Date: 20260505
Application Date: 20240925

Claims (19)

1 . A method of uterine hemostasis using a postpartum hemorrhage mitigation device that is configured to be disposed within a uterine cavity of a uterus after childbirth, wherein the postpartum hemorrhage mitigation device includes a suction line and an anchoring mechanism, the suction line having a distal portion and a proximal portion, the proximal portion comprising a suction line extension, wherein the anchoring mechanism is configured to maintain the suction line extension in a desired position within the uterine cavity, the method comprising: (a) inserting the distal portion of the suction line through a cesarian incision into the uterine cavity; (b) guiding the distal portion of the suction line through the uterine cavity, into and through the cervix, and into and through the vagina; (c) positioning the anchoring mechanism adjacent the internal cervical OS of the uterine cavity; (d) closing the cesarian incision to enclose the proximal portion of the suction line within the uterine cavity; (e) connecting the distal portion of the suction line to a source of negative pressure, thereby introducing negative pressure to the uterine cavity via the suction line during a treatment period, which causes contraction of the uterus and evacuation of fluid from the uterus via the suction line extension; (f) upon completion of the treatment period, detaching the suction line from the source of negative pressure; and (g) extracting the suction line extension and the anchoring mechanism from the uterus by pulling the proximal portion of the suction line through the cervical canal and into the vagina.
2 . The method of claim 1 , wherein the distal portion of the suction line includes a tapered tip, and wherein: step (a) comprises inserting the tapered tip into through the cesarian incision and into the uterine cavity; step (b) comprises guiding the tapered tip through the uterine cavity, into and through the cervical canal, and into and through the vagina; and step (e) comprises removing the tapered tip from the distal portion of the suction line before connecting the distal portion of the suction line to the source of negative pressure.
3 . The method of claim 1 , wherein step (c) creates a fluid seal between the anchoring mechanism and the internal cervical OS.
4 . The method of claim 1 , wherein the anchoring mechanism of the postpartum hemorrhage mitigation device comprises a placement marker that is configured to slide along an outside surface of the suction line, and wherein step (c) further comprises sliding the placement marker into a location on the suction line that provides for proper positioning of the suction line extension based on the size of the uterus.
5 . The method of claim 1 , wherein step (e) comprises applying a negative pressure of 100 mmHG to the suction line.
6 . The method of claim 1 , wherein step (d) comprises leaving the abdomen open to allow for visual monitoring of uterine collapse during at least a portion of the treatment period.
7 . The method of claim 1 , wherein step (g) is performed from one hour to twenty-four hours after completion of step (d).
8 . The method of claim 1 , wherein the anchoring mechanism of the postpartum hemorrhage mitigation device collapses enough during performance of step (g) to allow passage of the anchoring mechanism and the suction line extension through the cervical canal and vagina.
9 . The method of claim 1 , wherein the suction line extension further comprises one or more ports, and wherein step (e) further comprises drawing the fluid through the one or more ports into the suction line extension for evacuation from the uterus.
10 . The method of claim 1 , wherein the postpartum hemorrhage mitigation device further comprises a stylet that is configured to slide into the proximal portion of the suction line, and wherein step (b) further comprises inserting the stylet into the suction line to reinforce the suction line and to aid in guiding the distal portion of the suction line through the uterine cavity and into and through the cervix.
11 . The method of claim 1 , further comprising monitoring an amount of fluid withdrawn from the uterus through the suction line during the treatment period.
12 . A method of uterine hemostasis using a postpartum hemorrhage mitigation device that includes a suction line and an anchoring mechanism attached to the suction line, the suction line having a distal portion and a proximal portion, the distal portion including a tapered tip, and the proximal portion including a suction line extension configured to be disposed within a uterine cavity of a uterus after childbirth, wherein the anchoring mechanism is configured to slide along an outside surface of the suction line to selectively adjust a position of the anchoring mechanism with respect to the suction line extension, the method comprising: (a) sliding the anchoring mechanism to a location on the suction line that will provide for proper positioning of the suction line extension based on the size of the uterus; (b) inserting the tapered tip of the suction line through a cesarian incision into the uterine cavity; (c) guiding the tapered tip of the suction line through the uterine cavity, into and through the cervix, and into and through the vagina; (d) positioning the anchoring mechanism adjacent the internal cervical OS of the uterine cavity, thereby creating a fluid seal between the anchoring mechanism and the internal cervical OS; (e) closing the cesarian incision to enclose the proximal portion of the suction line within the uterine cavity; (f) removing the tapered tip from the suction line and connecting the distal portion of the suction line to a source of negative pressure, thereby introducing negative pressure to the uterine cavity via the suction line during a treatment period, which causes contraction of the uterus and evacuation of fluid from the uterus via the suction line extension; (g) upon completion of the treatment period, detaching the suction line from the source of negative pressure; and (h) extracting the suction line extension and the anchoring mechanism from the uterus by pulling the proximal portion of the suction line through the cervical canal and into the vagina.
13 . The method of claim 12 , wherein step (f) comprises applying a negative pressure of 100 mmHG to the suction line.
14 . The method of claim 12 , wherein step (e) comprises leaving the abdomen open to allow for visual monitoring of uterine collapse during at least a portion of the treatment period.
15 . The method of claim 12 , wherein step (h) is performed from one hour to twenty-four hours after completion of step (d).
16 . The method of claim 12 , wherein the anchoring mechanism of the postpartum hemorrhage mitigation device collapses enough during performance of step (h) to allow passage of the anchoring mechanism and the suction line extension through the cervical canal and vagina.
17 . The method of claim 12 , wherein the suction line extension further comprises one or more ports, and wherein step (f) further comprises drawing the fluid through the one or more ports into the suction line extension for evacuation from the uterus.
18 . The method of claim 12 , wherein the postpartum hemorrhage mitigation device further comprises a stylet that is configured to slide into the proximal portion of the suction line, and wherein step (c) further comprises inserting the stylet into the suction line to reinforce the suction line and to aid in guiding the distal portion of the suction line through the uterine cavity and into and the cervix.
19 . The method of claim 12 , further comprising monitoring an amount of fluid withdrawn from the uterus through the suction line during the treatment period.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This patent application claims the priority and benefit of U.S. patent application Ser. No. 18/500,571, filed Nov. 2, 2023, which is a continuation of U.S. patent application Ser. No. 18/185,311, filed Mar. 16, 2023, which issued as U.S. Pat. No. 11,839,408 on Dec. 12, 2023, and which claims the priority and benefit of U.S. patent application Ser. No. 63/328,257, filed on Apr. 6, 2022. The disclosure of the aforementioned applications is hereby incorporated by reference herein in its entirety including all references cited therein. INVENTIVE FIELD The present technology pertains to medical devices. The present technology, in particular, pertains to systems, devices, and methods for monitoring and controlling postpartum hemorrhage and excessive uterine bleeding. BACKGROUND Postpartum hemorrhage (PPH) is the leading cause of maternal morbidity and mortality worldwide and is responsible for twenty-five percent of maternal deaths. Complications for PPH are also high with more than 1.5 million women annually experiencing morbidities. Literature states that the incidence and severity are increasing in both low-resourced and high-resourced settings. Uterine atony is the root cause of nearly eighty percent of PPH's and uterine atony is also the most preventable. Other less common causes include trauma, coagulopathy and retained tissue. After the placenta is delivered, the uterus must contract the fibers of the myometrium to control the bleeding. If the uterus remains atonic, the vessels are unable to constrict causing hemorrhage. Postpartum hemorrhage is a condition that occurs when a woman's uterus bleeds more than 500 mL of blood within 24 hours following vaginal childbirth or 1000 mL of blood within twenty-four hours following cesarean childbirth. Often, the condition is caused when the woman's uterus fails to contract postpartum, which leaves blood vessels within the uterus open, so they continue to bleed. Postpartum hemorrhage may lead to a significant loss of blood from, and in extreme cases death of the woman. Traditionally, it is difficult to diagnose and/or determine the amount of postpartum hemorrhage because it is difficult to determine or measure the volume of postpartum blood-loss, as there are inadequate means to capture the blood and accurately measure it. This is further complicated by blood pooling in the uterine cavity over time. This pooled blood may be held in place via, for example, a blood clot that forms at the base of the uterus and covers the opening to the cervical canal so that the woman may be bleeding internally (occult blood loss) with no vaginal bleeding to alert medical staff that postpartum hemorrhage may be occurring. SUMMARY In some aspects, the techniques described herein relate to a postpartum hemorrhage mitigation device including: a flexible tube including: a distal end; a proximal tip, the proximal tip including a suction line extension being configured for placement in a uterine cavity of a uterus after childbirth either vaginally or via cesarean section; a tube center of the flexible tube; and at least one lumen around the tube center, the at least one lumen including a suction line, the suction line being in communication with a source of negative pressure and the suction line extension, the suction line extension being configured for applying the negative pressure to the uterine cavity using the source of the negative pressure thereby causing mechanical hemostasis of bleeding blood vessels of a uterine wall of the uterine cavity; and an anchoring mechanism being proximate to the suction line extension along the flexible tube, the anchoring mechanism being configured for maintaining the suction line extension in a desired position within the uterine cavity. In some aspects, the techniques described herein relate to a postpartum hemorrhage mitigation device, wherein the suction line extension further includes one or more ports, the one or more ports being configured for drawing blood and other bodily fluids into the suction line extension from the bleeding blood vessels of the uterus. In some aspects, the techniques described herein relate to a postpartum hemorrhage mitigation device, wherein at least one of the suction line extension and the suction line include volumetric indications, the volumetric indications being configured for measurement of a volume of blood within the suction line extension and the suction line for quantifying blood loss from the bleeding blood vessels of the uterus for a clinician to evaluate postpartum hemorrhaging. In some aspects, the techniques described herein relate to a postpartum hemorrhage mitigation device, wherein the one or more ports include a plurality of ports, the plurality of ports including at least one of round pores, slits, and oval pores. In some aspects, the techniques described herein relate to a postpartum hemorrhage mitigation device, wherein the one or more ports include both suctio