Uterine hemorrhage controlling system and method
Inventors
Norred, Alexander James • Carlin, Davis Reed • Harper, George Cochran • Lagrew, JR., David C. • Degenkolb, Amelia Michele
Assignees
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Publication Number
US-12076047-B2
Publication Date
2024-09-03
Expiration Date
Abstract
A method of reducing postpartum bleeding includes positioning a device comprising a vacuum element within the uterus; sealing the uterus; activating vacuum in the uterus with the vacuum element of the device while the uterus is sealed; and collapsing the uterus with the vacuum to reduce postpartum bleeding.
Core Innovation
The invention relates to an improved method of reducing postpartum bleeding by positioning a device comprising a vacuum element and a sealing element. The vacuum element has a plurality of openings along a circumference, and the vacuum element is positioned distal to the sealing element so that the sealing element is located within the vaginal canal while the plurality of openings are located within the uterine cavity distal to the vaginal canal. The device thereby seals the uterus and enables activating vacuum in the uterine cavity through the openings while the uterine cavity is sealed.
The method includes collapsing the uterine cavity with the vacuum to reduce postpartum bleeding, where collapsing comprises collapsing uterine walls onto a shield of the device. This shield is used so as to prevent obstruction of the plurality of openings. The document further describes an approach to maintain an isobaric vacuum condition, with the uterine cavity sealed during vacuum activation and collapse.
The document also describes additional device configurations that preserve opening access during collapse. One configuration uses a curved loop vacuum element with openings along an inner circumference and collapses uterine walls onto an outer circumference of the curved loop vacuum element to prevent obstruction of the openings. Another configuration uses transvaginally delivered set of suction tubes including an outer suction tube with a curved loop portion and a shorter inner suction tube positioned within the outer tube, with collapse driven so uterine walls collapse onto the outer suction tube to prevent obstruction of the openings.
Claims Coverage
The provided independent claims cover three distinct methods of reducing postpartum bleeding. Across the independent claims, the core coverage centers on positioning or transvaginal delivery of a vacuum or suction-tube device with a sealing element, activating negative pressure through openings located in the uterine cavity, and collapsing the uterine cavity in a way that prevents obstruction of the openings by using a shield, loop, or outer circumference.
Sealed uterine vacuum through circumferential openings with protected opening access
Positioning a device comprising a vacuum element and a sealing element such that the sealing element is within the vaginal canal and the vacuum element openings are within the uterine cavity distal to the vaginal canal; sealing the uterus with the sealing element; activating vacuum in the uterine cavity through the openings while the uterine cavity is sealed; and collapsing the uterine cavity with the vacuum to reduce postpartum bleeding, wherein collapsing comprises collapsing uterine walls onto a shield to prevent obstruction of the plurality of openings.
Curved loop vacuum element with uterine wall collapse onto outer circumference to avoid opening blockage
Positioning a device comprising a curved loop vacuum element and a sealing element such that the sealing element is within the vaginal canal and openings along an inner circumference are within the uterine cavity distal to the vaginal canal; sealing the uterus; activating vacuum in the uterine cavity through the openings of the curved loop vacuum element while the uterine cavity is sealed; and collapsing the uterine cavity with the vacuum to reduce postpartum bleeding, wherein collapsing comprises collapsing uterine walls onto an outer circumference of the curved loop vacuum element so as to prevent obstruction of the plurality of openings.
Transvaginal suction-tube delivery with outer loop openings protected by uterine wall collapse
Transvaginally delivering a device into a uterus comprising a set of suction tubes and a sealing element such that the sealing element is within the vaginal canal and plurality of openings are within the uterine cavity distal to the vaginal canal; sealing the uterus with the sealing element; transmitting via the set of suction tubes a negative pressure to an interior of the uterine cavity while the uterine cavity is sealed; and collapsing the uterine cavity with the negative pressure to reduce postpartum bleeding, wherein collapsing comprises collapsing uterine walls onto an outer suction tube so as to prevent obstruction of the plurality of openings.
Across the independent claims, the methods reduce postpartum bleeding by sealing the uterus via a sealing element in the vaginal canal, delivering vacuum or negative pressure through uterine-cavity openings, and collapsing uterine walls in a manner that prevents obstruction of the openings using a shield, loop, or outer suction-tube surface.
Stated Advantages
Reduces postpartum bleeding.
Prevents obstruction of the plurality of openings during collapsing by using a shield or outer circumference.
Maintains uterine cavity sealed during vacuum activation through the openings.
Documented Applications
Clinical single-arm study comparing a suction module embodiment against a Bakri Postpartum Balloon comparator, reporting treatment success rates and time to control.
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