Systems, Devices, And Methods For Uterine Hemostasis

Patent No. US11839408 (titled "Systems, Devices, And Methods For Uterine Hemostasis") was filed by Lucie Medical Inc on Mar 16, 2023.

What is this patent about?

’408 is related to the field of medical devices, specifically those used for managing postpartum hemorrhage (PPH), a leading cause of maternal mortality. Current methods for quantifying blood loss are often inaccurate, and effective treatments for uterine atony, the primary cause of PPH, are needed to improve outcomes and reduce complications associated with excessive bleeding after childbirth.

The underlying idea behind ’408 is to apply negative pressure directly to the uterine cavity to promote mechanical hemostasis of bleeding blood vessels in the uterine wall. This is achieved by inserting a flexible tube with a suction line extension into the uterus and connecting it to a vacuum source. The negative pressure encourages uterine contraction, helping to close blood vessels and control bleeding.

The claims of ’408 focus on a postpartum hemorrhage mitigation device featuring a flexible tube with a suction line extension for placement in the uterine cavity. The tube includes a suction line connected to a negative pressure source. An anchoring mechanism maintains the device's position, and a placement marker allows for size adjustment. Critically, the suction ports are arranged in a 180-degree spiral to prevent blockage.

In practice, the device is inserted into the uterus after childbirth, either vaginally or via cesarean section. The anchoring mechanism ensures the suction line extension remains in the correct position to apply negative pressure effectively. The spiral arrangement of the suction ports is a key feature, preventing occlusion by the uterine wall or blood clots, ensuring continuous suction and promoting uterine contraction.

The device differentiates itself from prior approaches by combining negative pressure therapy with a design that addresses common challenges in postpartum hemorrhage management. The volumetric indications on the suction line allow for accurate blood loss measurement, while the adjustable placement marker and various anchoring mechanisms ensure proper positioning and prevent device migration. The protection pores prevent damage to the uterine lining.

How does this patent fit in bigger picture?

Technical landscape at the time

In the early 2020s when ’408 was filed, medical devices often incorporated features for precise placement and monitoring within the body. At a time when minimally invasive procedures were increasingly common, devices commonly relied on flexible materials and steerable tips to navigate complex anatomies. When hardware or software constraints made real-time feedback non-trivial, physical markings and anchoring mechanisms were often used to ensure proper positioning and functionality.

Novelty and Inventive Step

The examiner approved the application because the prior art does not teach or suggest a postpartum hemorrhage mitigation device that includes a placement marker that is movable along the suction line extension to personalize the size of the device to the size of the uterus, where the placement marker covers one or more ports, and that further includes an anchoring mechanism along the flexible tube.

Claims

The patent has 15 claims, with claims 1, 14, and 15 being independent. The independent claims are directed to a postpartum hemorrhage mitigation device that includes a flexible tube with a suction line extension for placement in the uterus, a placement marker, and an anchoring mechanism. The dependent claims generally add specific features or limitations to the device described in the independent claims.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Anchoring mechanism
(Claim 1, Claim 14, Claim 15)
“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.”A component proximate to the suction line extension along the flexible tube that maintains the suction line extension in a desired position within the uterine cavity.
One-hundred-and-eighty-degree spiral configuration
(Claim 14, Claim 15)
“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, the suction line extension including one or more ports, the one or more 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 one or more ports including suction ports, the suction ports being positioned in a one-hundred-and-eighty-degree spiral configuration around a tube center of the flexible tube, the one-hundred-and-eighty-degree spiral configuration preventing blockage of all of the suction ports”A specific arrangement of suction ports around the tube center of the flexible tube that prevents blockage of all suction ports.
Placement marker
(Claim 1, Claim 14, Claim 15)
“In some aspects, the techniques described herein relate to a postpartum hemorrhage mitigation device, further including an hourglass shaped placement marker, the hourglass shaped placement marker being configured for movement along the suction line for personalization of the postpartum hemorrhage mitigation device to a size of the uterus. In some aspects, the techniques described herein relate to a postpartum hemorrhage mitigation device, wherein the hourglass shaped placement marker covers one or more ports.”A component configured for movement along the suction line extension for personalization of the postpartum hemorrhage mitigation device to a size of the uterus, the placement marker covering one or more ports
Suction line extension
(Claim 1, Claim 14, Claim 15)
“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.”A component of the flexible tube, located at the proximal tip, that is configured for placement in the uterine cavity and connected to a suction line to apply negative pressure.
Volumetric indications
(Claim 14)
“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.”Markings on the suction line extension and suction line that allow for measurement of blood volume to quantify blood loss.

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US11839408

LUCIE MEDICAL INC
Application Number
US18185311
Filing Date
Mar 16, 2023
Status
Granted
Expiry Date
Mar 16, 2043
External Links
Slate, USPTO, Google Patents