Systems, devices, and methods for uterine hemostasis
A device may include a flexible tube comprising: a distal end, a proximal tip, the proximal tip comprising a suction line extension being configured for placement in a uterine cavity of a uterus after childbirth, a tube center of the flexible tube; and at least one lumen around the tube center, the at least one lumen comprising 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. Embodiments include 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.
1 . A postpartum hemorrhage mitigation device comprising:
a flexible tube comprising:
a distal end;
a proximal tip, the proximal tip comprising 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 comprising 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
a placement marker proximate the suction line extension along the flexible tube, the placement marker being configured for proper positioning of the postpartum hemorrhage mitigation device to a size of the uterus.
2 . The postpartum hemorrhage mitigation device of claim 1 , wherein the suction line extension further comprises 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.
3 . The postpartum hemorrhage mitigation device of claim 2 , wherein the one or more ports comprise a plurality of ports, the plurality of ports comprising at least one of round pores, slits, and oval pores.
4 . The postpartum hemorrhage mitigation device of claim 3 , wherein the plurality of ports comprises a combination of slits and round pores or oval pores.
5 . The postpartum hemorrhage mitigation device of claim 2 , the one or more ports being positioned in a spiral configuration around the tube center.
6 . The postpartum hemorrhage mitigation device of claim 1 , wherein at least one of the suction line extension and the suction line comprise volumetric indications, the volumetric indications being configured for measurement of a volume of blood within the suction line extension and/or the suction line for quantifying blood loss from the bleeding blood vessels of the uterus for a clinician to evaluate postpartum hemorrhaging.
7 . The postpartum hemorrhage mitigation device of claim 1 , the suction line extension comprising protection pores, the protection pores protruding beyond an outer boundary of the flexible tube for protecting endometrium of the uterine wall from damage during suction.
8 . The postpartum hemorrhage mitigation device of claim 1 , wherein the device is configured to be inserted into the uterus via a hysterotomy incision.
9 . The postpartum hemorrhage mitigation device of claim 8 , further comprising a stylet.
10 . The postpartum hemorrhage mitigation device of claim 9 , wherein the stylet comprises a rod placed inside the lumen to reinforce the lumen, the rod being configured for aiding directing of the suction line into place during insertion of the postpartum hemorrhage mitigation device from within the uterine cavity.
11 . The postpartum hemorrhage mitigation device of claim 8 , wherein the suction line comprises a semi-flexible catheter.
12 . The postpartum hemorrhage mitigation device of claim 8 , wherein a tip of the flexible tube further comprises a semi-ridged end, the semi-ridged end being configured for steerability and push-ability of the postpartum hemorrhage mitigation device.
13 . The postpartum hemorrhage mitigation device of claim 8 , wherein the flexible tube is tapered towards the distal end for positioning of the postpartum hemorrhage mitigation device within the uterine cavity.
14 . The postpartum hemorrhage mitigation device of claim 1 , the placement marker comprising an hourglass shape.
15 . The postpartum hemorrhage mitigation device of claim 14 , wherein the hourglass shaped placement marker is configured to cover one or more ports.
16 . The postpartum hemorrhage mitigation device of claim 1 , wherein the placement marker is a wavy placement anchor.
17 . The postpartum hemorrhage mitigation device of claim 1 , wherein the lumen comprises a hydrophilic coating, the hydrophilic coating providing compatibility with bodily fluids and reducing friction of the lumen.
18 . A postpartum hemorrhage mitigation device comprising:
a flexible tube comprising:
a distal end;
a proximal tip, the proximal tip comprising a suction line extension being configured for placement in a uterine cavity of a uterus after childbirth either vaginally or via cesarean section, the suction line extension comprising a plurality of ports, the plurality of ports being configured for drawing blood and other bodily fluids into the suction line extension from bleeding blood vessels of a uterine wall of the uterine cavity, the plurality of ports facing in all directions about the suction line extension to prevent blockage of all of the ports;
at least one lumen around a tube center of the flexible tube, the at least one lumen comprising 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 the bleeding blood vessels of the uterine wall of the uterine cavity; and
a placement marker proximate the suction line extension along the flexible tube, the placement marker being configured for proper positioning of the postpartum hemorrhage mitigation device to a size of the uterus.
19 . A postpartum hemorrhage mitigation device comprising:
a flexible tube comprising:
a distal end;
a proximal tip, the proximal tip comprising a suction line extension being configured for placement in a uterine cavity of a uterus after childbirth either vaginally or via cesarean section, the suction line extension comprising a plurality of ports, the plurality of ports being configured for drawing blood and other bodily fluids into the suction line extension from bleeding blood vessels of a uterine wall of the uterine cavity, the plurality of ports comprising a tip port at the proximal tip and one or more ports along the suction line extension;
at least one lumen around a tube center of the flexible tube, the at least one lumen comprising 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 the bleeding blood vessels of the uterine wall of the uterine cavity; and
a placement marker proximate the suction line extension along the flexible tube, the placement marker being configured for proper positioning of the postpartum hemorrhage mitigation device to a size of the uterus.