Postpartum uterine bleeding device

Abstract

To provide a system capable of reducing or completely stopping uterine bleeding.SOLUTION: A hemorrhage control device includes an elongate body 238, a flexible looped portion 232, a shield 233, and an inflatable seal 222. The elongate body is configured to be connected to a vacuum source. The flexible looped portion is attached to the elongate body and includes a plurality of holes on an inner circumference thereof. The flexible looped portion is configured to be disposed within a uterus. Activation of the vacuum source is configured to draw a vacuum through the plurality of holes to deflate the uterus when the elongate body is inserted into the uterus. The shield has an edge that folds around the outer periphery of the looped portion and extends radially inward relative to the flexible looped distal portion. The shield is configured to prevent tissue from blocking the plurality of holes when the vacuum is applied. The inflatable seal is attached to the elongate body and is configured to seal the uterus.SELECTED DRAWING: Figure 2A

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 861,233, entitled "Postpartum Uterine Hemorrhage Device," filed June 13, 2019, the entire contents of which are incorporated herein by reference. This application also claims priority to U.S. Provisional Patent Application No. 62 / 777,642, entitled "Postpartum Uterine Hemorrhage Device," filed December 10, 2018, the entire contents of which are incorporated herein by reference.

[0002] This application may also be related to U.S. Patent Application Publication No. 2019 / 083132, filed July 13, 2018, entitled "Uterine Hemorrhage Controlling System and Method," the entire contents of which are incorporated herein by reference.

[0003] This application may also be related to U.S. Patent Application Publication No. 2018 / 0055523, filed August 22, 2017, entitled "Uterine Hemorrhage Controlling System and Method," the entire contents of which are incorporated herein by reference. Literature citations

[0004] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. [Background technology]

[0005] Postpartum hemorrhage, defined as excessive blood loss after childbirth, is a leading cause of maternal mortality worldwide, resulting in more than 125,000 deaths each year. Uncontrolled postpartum hemorrhage can require multiple blood transfusions, and in severe cases, complete removal of the uterus can lead to death. Therefore, it is desirable to suppress postpartum hemorrhage, if possible, at the onset of the condition. Approximately 80% of cases of postpartum hemorrhage are caused by uterine atony, which is the inability of a woman's uterus to contract after delivery. Risk factors for uterine atony include prolonged labor, preeclampsia, and multiple parities. Therefore, a system that can rapidly induce uterine contractions and reduce or completely stop uterine bleeding is needed. Summary of the Invention [Problem to be solved by the invention]

[0006] The present invention has been made to solve the problems in the prior art described above. [Means for solving the problem]

[0007] In general, in one embodiment, a bleeding prevention device includes an elongate body, a flexible loop portion, a shield, and an inflatable seal. The elongate body is configured to be connected to a vacuum source. The flexible loop portion is attached to the elongate body and includes a plurality of holes on an inner periphery thereof. The flexible loop portion is configured to be positioned within a uterus. Activation of the vacuum source is configured to draw a vacuum through the plurality of holes to collapse the uterus when the elongate body is inserted into the uterus. The shield folds around the outer periphery of the loop portion and has an edge that extends radially inward relative to the flexible distal loop portion. The shield is configured to prevent tissue from blocking the plurality of holes when a vacuum is applied. The inflatable seal is attached to the elongate body and configured to seal the uterus.

[0008] This and other embodiments may include one or more of the following features: The flexible looped portion may be configured to collapse upon delivery and self-expand into an inflated loop shape. The shield may extend around 270-320° of the circumference of the flexible looped distal portion. The shield may extend radially inward a distance of 0.02-0.020". The plurality of holes may include 10-20 holes. The sealant may include a disc-shaped central portion and tapered proximal and distal ends. The device may further include a valved port in fluid communication with the elongate body. The valved portion may be configured to provide inflation fluid to the inflatable sealant. The valve may include a check valve.

[0009] In general, in one embodiment, a bleeding prevention device includes a first elongated tube, a second elongated tube, a connector, and a plurality of holes. The first elongated tube has a first central channel. The second elongated tube has a second central channel and is joined to and parallel to the first elongated tube, thereby forming an axial valley between the first and second elongated tubes. The connector is configured to connect the first and second central channels to a vacuum source. The plurality of holes are disposed along the valley. Each of the plurality of holes extends from an outer surface of the device and connects to both the first and second central channels. Activation of the vacuum source is configured to draw a vacuum through the plurality of holes to deflate the uterus when the device is inserted into the uterus.

[0010] This and other embodiments may include one or more of the following features: Each of the plurality of holes may include an elongated shape along the valley. Each of the plurality of holes may include a circular shape along the valley. The bleeding prevention device may further include a sealant disposed along the first and second elongated tubes. The sealant may have a disk-shaped central portion and tapered proximal and distal ends. The valleys may be 0.02" to 0.20" deep. The valley angle may be 10 to 80 degrees. The ratio of the device width to the device height may be 1.4 to 2.3, wherein the width and height are perpendicular to the axial valleys. The ratio of the device height to the device width may be 1.4 to 2.3, wherein the width and height are perpendicular to the axial valleys. The ratio of the device height to the device width may be about 1, wherein the width and height are perpendicular to the axial valleys. Each of the plurality of holes may extend completely through the valleys from the outer surface to the opposite second outer surface. The bleeding prevention device may further include a tapered distal tip.

[0011] In general, in one embodiment, a bleeding prevention device includes an elongate body and a sealant. The elongate body is configured to be connected to a vacuum source and has a plurality of holes. Activation of the vacuum source is configured to draw a vacuum through the plurality of holes to collapse the uterus when the elongate body is inserted into the uterus. The sealant is attached to the elongate body and configured to seal the uterus. The sealant includes a proximal ring and a distal skirt and is configured to have a generally conical shape.

[0012] This and other embodiments may include one or more of the following features: The sealant may be proximal to the hole; The skirt may be at an angle of 30-60 degrees relative to the elongate body; The ring may be 2-10 mm in diameter; The ring may be stiffer than the skirt; The ring may be thicker than the skirt; The skirt may be 1-1.5 mm in thickness; The ring may be in the plane of a plane generally perpendicular to the longitudinal axis of the elongate body; The proximal ring may be configured to press against tissue of the vaginal canal or cervical wall; The sealant may be configured to evert when the elongate body is pulled proximally; The skirt may connect to the outermost diameter of the proximal ring when everted; The skirt may vary in thickness from its proximal end to its distal end; or The skirt may be uniform in thickness from its proximal end to its distal end.

[0013] The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and by reference to the accompanying drawings in which: [Brief explanation of the drawings]

[0014] [Figure 1A] 1 illustrates an exemplary system for controlling uterine bleeding. [Figure 1B] 1 illustrates another exemplary system for controlling uterine bleeding. [Figure 2A] FIG. 1 is a side perspective view of an exemplary insertable device for controlling uterine bleeding. [Figure 2B] FIG. 2B is another side perspective view of the insertable instrument of FIG. 2A. [Figure 2C] FIG. 2B is another side perspective view of the insertable instrument of FIG. 2A. [Figure 2D] FIG. 2B is a perspective view of the shield of the insertable instrument of FIG. 2A. [Figure 2E] FIG. 2B is a cross-sectional view of the shield of the insertable instrument of FIG. 2A. [Figure 2F] FIG. 2B is a detailed view of the shield of the insertable instrument of FIG. 2A. [Figure 2G]FIG. 2B is a development view of the inner periphery of the loop portion of the insertable instrument of FIG. 2A. [Figure 2H] FIG. 2B is a side view of the sealant of the insertable instrument of FIG. 2A. [Figure 2I] 2B is a cross-sectional view of the proximal end of the insertable instrument of FIG. 2A. [Figure 3] FIG. 1 is a perspective view of another exemplary insertable device for controlling uterine bleeding. [Figure 4] FIG. 1 is a perspective view of another exemplary insertable device for controlling uterine bleeding. [Figure 5] FIG. 1 is a perspective view of another exemplary insertable device for controlling uterine bleeding. [Figure 6A] 1 is a cross-sectional view of another device for controlling uterine bleeding. [Figure 6B] 6B shows a side view of the insertable device of FIG. 6A. [Figure 7] 1 is a cross-sectional view of another device for controlling uterine bleeding. [Figure 8] 1 is a cross-sectional view of another device for controlling uterine bleeding. [Figure 9] 1 is a cross-sectional view of another device for controlling uterine bleeding. [Figure 10] 1 is a cross-sectional view of another device for controlling uterine bleeding. [Figure 11] 1 is a cross-sectional view of another device for controlling uterine bleeding. [Figure 12A] FIG. 1 is a perspective view of another exemplary insertable device for controlling uterine bleeding. [Figure 12B] FIG. 12B is a cross-sectional view of the insertable instrument of FIG. 12A. [Figure 13A] FIG. 1 is a perspective view of another exemplary insertable device for controlling uterine bleeding. [Figure 13B] FIG. 13B is a cross-sectional view of the insertable instrument of FIG. 13A. [Figure 13C] 1A-1C are perspective views of several different insertable devices for controlling uterine bleeding. [Figure 14] 1 shows an exemplary distal tip of an insertable device for controlling uterine bleeding. [Figure 15A] 10 shows another exemplary distal tip of an insertable device for controlling uterine bleeding. [Figure 15B]15B shows the distal tip of FIG. 15A being pressed against tissue. [Figure 16] FIG. 10 is a side view of another exemplary insertable device for controlling uterine bleeding. [Figure 17A] 1 illustrates a foam sealant for one exemplary insertable device for controlling uterine bleeding. [Figure 17B] 17B shows the foam encapsulant of FIG. 17A in a compressed configuration. [Figure 18] FIG. 10 is a side view of another exemplary sealant for use in an insertable device for controlling uterine bleeding. [Figure 19] FIG. 10 is a side view of another exemplary sealant for use in an insertable device for controlling uterine bleeding. [Figure 20] FIG. 10 is a top view of another exemplary sealant for use in an insertable device for controlling uterine bleeding. [Figure 21] FIG. 10 is a side perspective view of another exemplary sealant for use in an insertable device for controlling uterine bleeding. [Figure 22] FIG. 10 is a side perspective view of another exemplary sealant for use in an insertable device for controlling uterine bleeding. [Figure 23A] FIG. 10 is a side perspective view of another exemplary sealant for use in an insertable device for controlling uterine bleeding. [Figure 23B] FIG. 23B is a side perspective view of the encapsulant of FIG. 23A having helical ridges or valleys. [Figure 24] FIG. 10 is a side perspective view of another exemplary sealant for use in an insertable device for controlling uterine bleeding. [Figure 25] FIG. 10 is a side perspective view of another exemplary sealant for use in an insertable device for controlling uterine bleeding. [Figure 26A] FIG. 10 is a side perspective view of another exemplary sealant for use in an insertable device for controlling uterine bleeding. [Figure 26B] 26B is a side perspective view of the sealant of FIG. 26A with the distal end rolled proximally. FIG. [Figure 27] FIG. 10 is a side perspective cross-sectional view of another exemplary sealant for use in an insertable device for controlling uterine bleeding. [Figure 28] 10A-10C are cross-sectional views of another exemplary sealant for use in an insertable device for controlling uterine bleeding. [Figure 29] 10A-10C are cross-sectional views of another exemplary sealant for use in an insertable device for controlling uterine bleeding. [Figure 30A] 1 is a cross-sectional view of another exemplary insertable device for controlling uterine bleeding. [Figure 30B] 30B illustrates the insertion of the insertable instrument of FIG. 30A. [Figure 30C] 30B shows the insertable device of FIG. 30A inverted. [Figure 30D] 30B illustrates the inversion of the insertable instrument of FIG. 30A when the shaft is pulled proximally. [Figure 31] 10A-10C are cross-sectional views of another exemplary insertable device for controlling uterine bleeding. [Figure 32] 1 shows the distal portion of an insertable device for controlling uterine bleeding collapsed. [Figure 33] 1 illustrates an exemplary placement of an insertable device within the body to control uterine bleeding. [Figure 34] 1 shows a syringe used to introduce inflation fluid into an insertable device for controlling uterine bleeding. [Figure 35] 1 shows an exemplary connecting tube for an insertable device for controlling uterine bleeding. [Figure 36] 12A-12B show the depth and angle of the valleys of the device. [Figure 37] 13A-13B show the depth and angle of the valleys of the device. DETAILED DESCRIPTION OF THE INVENTION

[0015] Described herein are uterine bleeding devices, systems, and methods that create a vacuum within the uterine space after delivery while drawing blood and / or clots from the uterine space. The vacuum can advantageously promote the physical collapse of the uterine space, which in turn induces trends within the uterus that help control bleeding.

[0016] FIG. 1A illustrates an exemplary system 100 for suppressing uterine bleeding, according to one embodiment. The system 100 functions to reduce or completely stop uterine bleeding that can occur if a woman develops uterine atony after delivery, a condition in which the uterus does not contract. Suppressing uterine bleeding substantially reduces the total amount of blood loss from the uterus, potentially reducing the need for blood transfusions or hysterectomies for the woman. In the embodiment of FIG. 1A, the system 100 promotes uterine contractions by sealing an opening to the uterus and varying the pressure within the uterus. The pressure change creates a vacuum within the uterus, which provides a uniform mechanical stimulus to the uterine wall, promoting tissue tamponade and contractile movement. In the embodiment of FIG. 1A, the system 100 includes an insertable device 105, a pump 110, and a collection container 115.

[0017] The insertable device 105 is configured to be inserted into the uterus and transmit pressure changes provided by the pump 110. In the embodiment of FIG. 1A, the insertable device 105 is delivered transvaginally (through the vagina), with a distal portion 120 of the insertable device 105 positioned within the uterus and a proximal portion 125 of the insertable device 105 remaining outside the uterus. The distal portion 120 may be flexible and conforms to the anatomical structure of the uterus. A sealant 122 between the distal portion 120 and the proximal portion 125 can form a seal at the uterine opening. The proximal portion 125 of the insertable device 105 is coupled to the pump 110. FIG. 33 illustrates an exemplary placement of the sealant 122 at a cervical opening 186 within a vaginal canal 189, with the distal portion 120 positioned within the uterus 188. In some embodiments, the insertable device 105 may have a sheath that facilitates insertion of the insertable device 105 into the uterus and may also prevent premature air flow from the pump 110 into the uterus.

[0018] The pump 110 generates pressure changes that create a vacuum within the uterus. In the embodiment of FIG. 1A, the pump 110 is coupled to a proximal portion 125 of the insertable instrument 105. In some embodiments, a connecting tube 130 is attached to the proximal portion 125 and the pump 110, thereby coupling the pump 110 to the insertable instrument 105. In some embodiments, a collection chamber 115 is located along the connecting tube 130 between the pump 110 and the proximal portion 125 to prevent blood from entering the pump 110, as described in more detail below. In some embodiments, the connecting tube 130 includes a directional control valve that allows fluid to flow in one direction and prevents fluid from flowing in the reverse direction. An exemplary connecting tube 130 is shown in FIG. 35. A connector 147 of the tube 130 is configured to mate with a connector 148 of the insertable instrument 105.

[0019] When activated, the pump 110 generates an airflow that is directed through the channels and / or openings in the insertable device 105 toward the uterus. Generally, vacuum pumps are configured to remove molecules from a sealed space, leaving behind a partial vacuum. Because the uterus is sealed (e.g., by the sealant 122) upon placement of the device 105, the airflow from the pump 110 reduces the pressure within the uterus, thereby reducing the pressure within the uterus below atmospheric pressure outside the uterus (e.g., to a pressure less than 1 atmosphere). This vacuum ensures that the airflow travels unidirectionally from the uterus through the insertable device 105 toward the pump 110. In some embodiments, the pump 110 may be configured to apply a vacuum pressure of 60-150 mmHg (e.g., 70-90 mmHg, e.g., approximately 80 mmHg). The vacuum within the uterus provides a uniform mechanical stimulation to the uterine wall, promoting uterine wall tamponade, arterial vasoconstriction, and contractile movement. Additionally, the vacuum created can aid in the removal of biological material from the uterus. The biological material may include blood, tissue, etc. Pump 110 may be electrically (automatically) operated or manually operated. In embodiments where pump 110 is manually operated, pump 110 may be capable of creating a vacuum within the uterus in a first state and of drawing biological material into collection container 115 while maintaining the vacuum within the uterus in a second state.

[0020] The collection container 115 collects biological material removed from the uterus. As shown in FIG. 1A , the collection container 115 may be connected in-line with the pump 110. The proximal portion 125 of the insertable instrument 105 is connected to the collection container 115 and the pump 110 by a connecting tube 130. In this embodiment, when the pump 110 is activated, fluid (e.g., air, biological material, etc.) flows through the connecting tube 130 toward the pump 110. The biological material is removed from the connecting tube 130 before reaching the pump 110 and collected in the collection container 115. Collecting biological material from the uterus may allow a user to monitor and measure the amount of blood loss due to uterine bleeding. Monitoring blood loss may also allow a user to determine whether, when, and / or to what extent uterine contractions have occurred.

[0021] In some embodiments, system 100 can be used to prevent postpartum hemorrhage in addition to monitoring and / or treating postpartum hemorrhage. For example, system 100 can be used to support uterine contractions in a woman after delivery. The flexibility of insertable instrument 105 allows a healthcare provider (e.g., a nurse, physician, surgeon, etc.) to palpate the woman's uterine tissue from the abdomen to detect whether and / or when the uterus has contracted. Additionally, the flexibility of insertable instrument 105 allows for folding, bending, and positioning of insertable instrument 105 during other vaginal wall or tissue repair surgical procedures. FIG. 32 shows distal portion 120 of instrument 105 manually folded in preparation for insertion into the uterus.

[0022] In some embodiments, insertable device 105 may be configured to remain outside the uterus and be inserted into the vaginal canal or cervix (e.g., the upper vaginal canal, the cervical orifice, or adjacent tissues). Sealant 122 may form a seal between the vaginal or cervical orifice and the uterus. By forming a seal, air flow from pump 110 may reduce the pressure inside the uterus below atmospheric pressure outside the uterus, creating a vacuum within the uterus. As previously discussed, this provides uniform mechanical stimulation to the uterine wall, promoting uterine wall tamponade, arterial vasoconstriction, and contractile movement.

[0023] FIG. 1B illustrates another embodiment of a system 200 for suppressing uterine bleeding. System 200 is similar to system 100, except that it does not include a separate collection chamber. Thus, system 200 includes an insertable device 105 and a pump 110. A proximal portion 125 of insertable device 105 is connected to pump 110 by a connecting tube 130. In this embodiment, a collection container may be integrated with pump 110, and fluid (e.g., air, biological material, etc.) flows through connecting tube 130 and into pump 110, where the biological material is collected in a separate compartment of pump 110. This compartment that collects the biological material may be detachable from pump 110. This may assist a healthcare provider in monitoring the amount of biological material collected.

[0024] 2A-2I show detailed views of insertable device 205, another embodiment similar to device 105. Insertable device 205 includes a proximal portion 225, a distal portion 220, and a seal 222 therebetween.

[0025] Proximal portion 225 includes an elongate body 238 or shaft that houses vacuum channel 231, a connector 237 for connecting channel 231 to a pump, an inflation channel 236, and a valved port 239 for introducing inflation medium into sealant 222 via inflation channel 236. In some embodiments, inflation channel 236 and vacuum channel 231 may extend adjacent and / or parallel to one another. The valve in valved port 239 may be, for example, a check valve that does not allow fluid flow when a syringe is not engaged and opens to allow fluid flow when a syringe is engaged. FIG. 34 shows an example syringe 234 configured to be inserted into valved port 239 to introduce inflation medium.

[0026] 2A-2I, the distal portion 220 includes a flexible loop portion 223, which collapses when delivered to the uterus and then self-expands to form a loop shape that conforms to the uterus. The loop portion 223 further includes an inner loop portion 232 and a shield 233. The inner loop portion 232 is continuous with and fluidly connected to the proximal portion 225. The inner loop portion 232 includes multiple holes 229 around its inner circumference for applying vacuum through the holes 229 (via connection with the vacuum channel 231). For example, there may be 10 to 30 holes 229 (e.g., 20 holes 229). The multiple holes 229 may be useful for providing redundancy in case one or more holes become blocked during use. The shield 233 conforms to the outer circumference of the inner loop portion 232 and is capable of folding around the outer circumference. For example, shield 233 may extend around 270-320° of the circumference of inner loop portion 232. Additionally, the edge of shield 233 may extend radially inward from inner loop portion 232 by a distance of 0.02-0.20 inches (e.g., 0.04-0.15 inches, e.g., about 0.08 inches). The overhanging edge of shield 233 may advantageously help protect holes 229 from being blocked by tissue when a vacuum is drawn through holes 229.

[0027] The sealant 222 may have a disk-shaped central portion 292 and tapered proximal and distal ends 293a, 293b. The sealant 222 may be, for example, an inflatable balloon that is inflated through a valved port 239. The volume of fluid used to inflate the sealant 222 may be, for example, 30 to 200 cc (e.g., 40 to 120 cc, e.g., about 60 cc).

[0028] In some embodiments, the insertable instrument (e.g., used in system 200) may have a different shape (i.e., a non-loop shape) and / or may be used without a separate shield. For example, FIGS. 3-13 show various exemplary insertable instruments. The instruments of FIGS. 3-13 may be designed to allow for aspirating surrounding fluid (through multiple distinct holes) while simultaneously using ridges and / or lips to prevent tissue and large clots from getting close enough to the holes to block flow. These multiple holes can advantageously both allow for redundancy in case some holes become blocked and distribute the vacuum load across the holes, thereby preventing the holes from becoming blocked by tissue and / or clots. Any of the instruments shown in FIGS. 3-13 may be extruded from a single material (e.g., a thermoplastic material such as polyurethane), for example. Such a single extrusion can advantageously provide flexibility and rigidity while keeping the cost of the design low. In some embodiments, the devices shown in Figures 3-13 may be made from multiple extrusions and / or molded parts of varying durometers that are fused together for optimal design. Forming holes in the extrusions may be done by, for example, drilling, punching, laser, or water jet cutting.

[0029] FIG. 3 illustrates an exemplary insertable instrument 305. The instrument 305 includes a generally straight (i.e., not looped) elongated shaft 333. The sidewall of the shaft 333 has a plurality of holes 301 extending outward from a central vacuum channel 307 (i.e., for applying a vacuum through the holes). Wings or ridges 331 extend radially from and along the length of the shaft 333. The ridges 331 are angled relative to one another such that a generally V-shaped groove is formed between the ridges 331 that extends along the length of the shaft 333. The outermost edges of the ridges 331 may be rounded and / or atraumatic to body tissue. In some embodiments, the ridges 331 may be arranged such that four ridges 331 form a generally "X"-shaped cross section of the instrument 305, as shown in FIG. 3. Additionally, holes 301 may be located between ridges 331 (e.g., at the base or apex of a V-shaped groove). Ridges 331 may help prevent tissue from being drawn into holes 301, thereby keeping holes 301 open for application of vacuum and removal of blood from the uterus. Additionally, holes 301 may be located in alternating and / or different positions along the longitudinal axis of shaft 333 (i.e., holes in adjacent grooves may be at different axial positions), which helps both to prevent clogging with tissue and to maintain stability of device 305.

[0030] 4 shows another exemplary insertable instrument 405. Instrument 405, like instrument 305, includes a generally straight shaft 433 with a plurality of holes 401 extending through its sidewall. Holes 401 are randomly spaced along shaft 433. Additionally, instrument 405 may include ridges on its surface and / or may include raised features around holes 401 to help prevent tissue from blocking holes 401 when a vacuum is applied.

[0031] 5 shows another exemplary insertable instrument 505. Instrument 505 is similar to instrument 305, but shaft 533 includes only three longitudinal ridges 531 with holes 501 between the ridges 531.

[0032] 11 shows another exemplary device 1105, which is similar to device 505, but includes sharp knife-like edges 1111 extending radially from each ridge 1131. Edges 1111 are curved inward to face circumferentially around device 1105 to assist in cutting through clots when device 1105 is twisted or rotated (e.g., clockwise in FIG. 11).

[0033] FIGS. 6A-6B illustrate another exemplary insertable instrument 605. Instrument 605 is similar to instrument 305, except that it includes two parallel ridges 631 a, b on each of the four sides of shaft 633. As shown, each pair of ridges 631 a, b may be positioned approximately 90 degrees apart from an adjacent pair. Holes 601 may extend within shaft 633 between the individual ridges 631 a, b of each pair of parallel ridges 631 a, b. Additionally, in some embodiments (as shown in FIGS. 6A-6B), holes 601 may be through-holes, allowing for full penetration from one side of shaft 633 through vacuum channel 607 to the other side. However, adjacent holes 601 may be longitudinally offset (as shown in FIG. 6B) to ensure the integrity of instrument 605.

[0034] 7 shows another exemplary insertable device 705, which is similar to device 605, except that it includes only three pairs of ridges 731 a, 731 b (each pair spaced approximately 120 degrees apart from the adjacent pair). Holes 701 may be similarly positioned within shaft 733 between the individual ridges 731 a, b of each pair of ridges 731 a, b.

[0035] 8 shows another exemplary insertable instrument 805, which is similar to instrument 605, except that it includes only two pairs of ridges 831 a,b (spaced approximately 180 degrees apart from one another). The holes 801 in the shaft 833 between the individual ridges 831 a,b of the pairs of ridges 831 a,b may be through-holes extending from one side of the instrument through the central vacuum channel 807 to the other side. Because there are only two sets of ridges spaced approximately 180 degrees apart from one another, the insertable instrument 805 may be substantially flat. This design may provide enhanced flexibility or pliability in one direction (i.e., the short axis) compared to another direction (i.e., the long axis).

[0036] 9 illustrates another exemplary insertable instrument 905, which includes a generally straight shaft 933 having a plurality of holes 901 extending from a central vacuum channel 907 within the sidewall of the shaft 933 to the exterior of the shaft 933 (i.e., for applying a vacuum through the holes 901). Protrusions 991 extend radially from the shaft 933 along the length of the shaft 933. The instrument 905 includes four protrusions, which are spaced approximately 90 degrees apart from one another. Additionally, the outermost tips of the protrusions 991 may each include a circumferential extension 995 having a crescent-shaped cross-section. The extensions 995 extend circumferentially around the instrument 905 (i.e., to provide the instrument 905 with a substantially circular profile that is atraumatic to human tissue). The open spaces 993 between the extensions 995 and between the protrusions 991 and the extensions 995 can advantageously allow vacuum to reach the holes 901, while the large circumferential coverage of the extensions 995 can prevent tissue from collapsing onto the holes 901. In some embodiments, the extensions 995 can include sharp inner edges 997, which can help twisting the device 905 in a clockwise or counterclockwise direction to cut through the clot.

[0037] FIG. 10 shows another exemplary insertable device 1005, which is similar to device 905 except that it includes only three protrusions 1091 (which are, for example, positioned approximately 120 degrees apart from each other).

[0038] Another exemplary insertable instrument 1205 is shown in FIGS. 12A-12B. The instrument 1205 includes a shaft 1233 that is generally straight and includes two adjacent, parallel tubular sections 1212a, 1212b. Each tubular section 1212a, b includes a vacuum channel 1207a, b extending therethrough. The junction between the two tubular sections 1212a, b forms a longitudinal valley 1221a, b therebetween, in which the bore 1201 may be located (i.e., the bore 1201 is connected to the two vacuum channels 1207a, b). Locating the bore 1201 within the longitudinal valley 1221a, b can advantageously help prevent tissue from being drawn into the bore 1201. In some embodiments, the diameter d of each of the vacuum channels 1207a, b is 1 / 2 . v may be 3 to 6 mm (e.g., 5 mm), and the distance d between the vacuum channels 1207a, b b The diameter of the hole 1201 may be 1 to 3 mm (for example, 1.5 mm), and the diameter of the hole 1201 may be 2 to 5 mm (for example, 3 mm).

[0039] Another exemplary insertable device 1305 is shown in FIGS. 13A-13C. Device 1305 is similar to device 1205, except that tubular sections 1312a,b of shaft 1333 are partially flattened, resulting in elliptical vacuum channels 1307a,b with deeper valleys 1321a,b, and an elongated cross-section of bore 1301 (although, of course, bore 1301 may also be circular in cross-section). In some embodiments (as shown in FIG. 13A), bore 1301 may be a through-hole that may extend from one side to the other. The orientation of the elliptical shape may advantageously allow for selective bending. For example, referring to FIG. 13B, device 1305 may be inserted into the uterus with a plane defined by the Y direction (i.e., the coronal plane) parallel to a delivery table on which the mother is lying supine. The direction of preferential flexion / bending is then in the X direction (perpendicular to the coronal plane), which coincides with the anatomical curvature of the uterus.

[0040] Referring to FIGS. 36-37, the valleys 1221, 1321 formed between the two tubular members 1212, 1312 of the devices 1205, 1305 (or similar devices) have a depth (d c ) and an angle (α). The angle α is formed by lines intersecting at a vertex at or near the bottom of the valleys 1221, 1321. c is measured from the apex of the angle to the top surface of the tubular member 1212, 1312. If the device 1205, 1305 is to be reused, a larger angle α makes it easier to clean the valleys 1221, 1321. However, a larger angle α may also lead to overlying tissue sagging and blocking holes at the bottom of the valleys 1221, 1321. A smaller angle α may make it less likely that overlying tissue will sag and block the holes, but the narrower the bottom of the valleys 1221, 1321, the more likely the valleys will become filled with blood clots. Furthermore, the narrower the valleys 1221, 1321, the more difficult it may be to clean the device 1205, 1305 if it is to be reused. Therefore, the depth d of the valleys 1221, 1321 may be adjusted to reduce the likelihood of overlying tissue sagging and blocking holes. cThe depth d may be 0.02 to 0.20 inches (for example, 0.05 to 0.12 inches). Furthermore, the angle α of the valleys 1221 and 1321 may be 10 to 80 degrees (for example, 20 to 65 degrees). c and angle α advantageously allows for proper cleaning of instruments 1205, 1305 while avoiding blockage by blood or hanging tissue.

[0041] 13C shows variations (1305a-1305j) of device 1305. Variations 1305a, 1305b, 1305e, and 1305f are flatter than the other variations (i.e., their thickness in the Y direction is less than their thickness in the X direction), and therefore, holes 1301 extend through a thinner cross-section. In contrast, variations 1305c, 1305d, 1305g, and 1305h have holes 1301 extend through a thicker cross-section (because their thickness in the Y direction is greater than their thickness in the X direction). Extending holes 1301 through a thicker cross-section (as in variations 1305c, 1305d, 1305g, and 1305h) allows holes 1301 to more easily align with the two adjacent uterine surfaces, thereby facilitating the aspirating of fluid from those two surfaces. In some embodiments, the ratio of width in the X direction to height in the Y direction (or vice versa) of the device of Figures 13A-13C may be between 1.4 and 2.3, thereby allowing for selective bending.

[0042] Any of the insertable instruments of FIGS. 3-13 may have a tapered and / or atraumatic distal tip to prevent damage to the uterine wall during insertion and use. For example, FIG. 14 shows an exemplary distal tip 1461. The distal tip 1461 may have a diameter equal to or smaller than the diameter of the remainder of the insertable instrument (e.g., the shaft of the insertable instrument). Similarly, an exemplary tip 661 is shown in FIG. 6B. The tip 661 may have a conical shape where the ridges 631 abut and / or terminate, so that the distal ends of none of the ridges 631 directly contact tissue. As shown in FIGS. 14 and 6B, in some embodiments, a central vacuum channel 1407, 607 may extend throughout the entire instrument (including the tips 1461, 661), for example, to provide additional vacuum ports at the distal end and / or to allow for flushing or cleaning of the instrument. 15A-15B, in some embodiments, the tip 1561 can be a soft dome that can collapse during engagement with tissue 1515 to avoid puncturing the uterus (as shown in FIGS. 15A-15B). In some embodiments, the dome tip 1561 can be hollow. In other embodiments, the dome tip 1561 can include a soft sponge-like material or molded webbing within it that provides optimized flexibility or softness for engagement with tissue.

[0043] 16 shows another exemplary insertable device 1605. The device 1605 includes a proximal bulbous structure 1616 and a distal bulbous structure 1618. A hole 1601 (for connecting to a vacuum channel) is located in a valley 1619 formed between the proximal bulbous structure 1616 and the distal bulbous structure 1618. The bulbous structures 1616, 1618 may be made of a soft material (e.g., foam or webbing) that is sufficiently collapsible when inserted through the cervix, yet rigid enough to prevent tissue from blocking the hole 1601 when a vacuum is applied.

[0044] Various sealant designs are possible for use with the bleeding prevention devices and systems described herein (e.g., systems 100 or 200, and / or systems having any of the instruments shown in FIGS. 2A-13C). For example, sealant 222 may be used in any of the instruments described herein. In one embodiment, sealant 222 may be disposed along shaft 1333 of instrument 1305. Similarly, FIGS. 17-30 show several various exemplary sealant designs that may be used in any of the instruments described herein.

[0045] 17A-17B show an insertable device 1705 having a sealant 1722. The sealant 1722 may be made of a thin, highly compliant sheath 1719 with a foam material 1771 therein. A vent hole or slit 1717 may extend through the proximal end of the sheath 1719, allowing air to enter the foam material 1771 and inflate the sealant 1722. As shown in FIG. 17B, the sealant 1722 may be collapsible (by squeezing with the palm of a hand or fingers before insertion into the body) and then inflated once inside the body to conform to the anatomy. In some embodiments, the sealant 1722 may be connected to an inflation lumen (e.g., running parallel to the vacuum lumen, as described above) to assist in the inflation of the sealant 1722. In another embodiment, exposing slit 1717 at the proximal end of sealant 1722 allows for sufficient air entrapment that an inflation lumen is not required.

[0046] 18 is a side view of an umbrella-shaped (or cone-shaped) diaphragm seal 1822 with an insertable instrument shaft 1833 extending above the center. The distal curved end (or skirt) 1881 of the diaphragm 1822 is intended to face the uterus (i.e., the narrow end is closest to the uterus), while the proximal ring 1882 can maintain the circular shape of the proximal end. The distal skirt 1881 can seal against the cervical opening, or the outer ring 1882 can seal against tissue in the vaginal canal or cervical canal, thereby creating a vacuum within the uterus. In some embodiments, the outer ring 1882 can maintain a seal within the uterus by compressing and / or continuously radially contacting tissue in the vaginal canal or cervical wall.

[0047] 30A-30D show an insertable device 3005 similar to insertable device 1822, which includes an umbrella-shaped (or conical) diaphragm seal 3022, with the shaft 3033 of the insertable device 3055 extending above the center of the seal 3022. Compared to seal 1822, the distal skirt 3081 of seal 3022 has a smaller angle α relative to the shaft 3033 (see FIG. 30A ) (e.g., angle α may be 30-60 degrees (e.g., approximately 45 degrees)). The proximal ring 3082 may be a heavy or rigid ring (e.g., a solid polymer ring with a diameter of 2-10 mm (e.g., approximately 5 mm)). A rigid ring 3082 advantageously maintains its circular or elliptical shape even when tissue collapses around the ring 3082. The distal skirt 3081 may also be thicker than the skirt of the sealant 1822 (eg, the wall thickness of the skirt 3081 may be 1-1.5 mm (eg, about 1.2 mm)).

[0048] 30B , when inserted into the vaginal or cervical canal, the ring 3082 can rest against the vaginal or cervical wall tissue 3031, sealing the device therein. The rigidity of the ring 3082 can advantageously help to maintain the shape of the ring 3082 in-plane (i.e., in the plane of the plane 3035 perpendicular to the longitudinal axis 3037 of the shaft 3033). The thick skirt 3081, when in place and taut, can also help to keep the ring 3082 in place (in the plane 3035 perpendicular to the longitudinal axis 3037) and prevent the ring 3082 from rotating, rolling over, and / or losing its seal. Anatomically, this design and orientation of the sealant 3082 can advantageously provide an optimal orientation for applying a seal against the vaginal or cervical wall tissue 3031.

[0049] 30C , the skirt 3081 of the insertable instrument 3005 may be configured to invert when the shaft 3033 is pulled proximally. That is, the flexible skirt 3081 may begin to unwind on itself when a force is applied in the proximal direction, typically beginning with the portion of the skirt closest to the shaft 3033. The tendency to invert (the force required to invert) may depend, for example, on the thickness of the skirt 3081 (particularly the thickness of the portion immediately adjacent the shaft 3033). Furthermore, the tendency to invert may depend on the angle α between the skirt 3081 and the shaft 3033. The larger the angle α, the more likely the inversion. Conversely, the smaller the angle α, the more resistant the skirt 3081 is to tipping or rotating the face of the ring 3082.

[0050] As shown in FIG. 30D , eversion of the skirt 3081 can form a conical tip 3091 that parts the vaginal or cervical wall tissue 3031 as it is pulled proximally. Additionally, the attachment of the ring 3082 to the skirt 3081 can be designed to provide the smoothest outer surface in the direction of removal to avoid damaging repair sutures 3098 that may be placed in the vaginal or cervical canal. For example, the attachment of the skirt 3081 to the stiff ring 3082 can be at the outermost diameter of the device 3005 when the skirt 3081 is everted, so that as the device 3005 is retracted proximally, the skirt 3081 (at the shallowest angle relative to the vaginal or cervical wall tissue 3031) can easily clear tissue, particularly repair sutures 3098, if any, on the vaginal or cervical wall. As the skirt gets longer (while the angle α gets smaller and the diameter of the stiff ring 3082 remains the same), the slope of the skirt against the tissue wall becomes shallower, making it easier to overcome the suture 3098.

[0051] Of course, it may be advantageous to maintain a perpendicular relationship between the face of the ring 3082 and the longitudinal axis of the shaft 3033, but some variation in that perpendicular relationship may also be useful to allow flexibility for various anatomical structures.

[0052] In some embodiments, the thickness of the skirt 3081 may vary from the proximal end to the distal end to optimize the bending pattern of the skirt 3081. For example, the thickness may be tailored for specific distances between the attachment to the shaft and the rigid ring. FIG. 31 shows an example insertable instrument 3105 with thinned portions 3187a,b along the length of the skirt 3181. The variation in thickness may be advantageous for instrument placement and actuation / sealing, as well as for enhancing the eversion mechanism upon instrument removal.

[0053] 19 is a side view of the cupping cuff sealant 1922 with the shaft 1933 of the insertable instrument extending above the center. The distal ring 1991 faces the uterus, surrounds the outside of the cervical opening, and can rest within the vaginal vault. The curved proximal end 1993 can cup the cervical opening to form a seal that holds the vacuum within the uterus.

[0054] 20 is a top view of foldable sealant 2022 in a partially folded configuration. Sealant 2022 is similar to sealant 1822 except that it includes radial folds 2020 that allow it to easily collapse into an umbrella shape during insertion (i.e., to easily fold into the smaller diameter vaginal or cervical canal), but after insertion, the umbrella shape expands to fill a larger space, forming a seal that holds the vacuum within the uterus.

[0055] 21 is an isometric view of a seal 2122 surrounding an insertable instrument shaft 2133. The seal 2122 is a flat, disk-shaped seal having multiple connected rings 2114 that allow the disk to telescope into a conical shape. In use, the outermost ring 2114 may trap vaginal or cervical tissue in a larger diameter space immediately after insertion, but may allow the instrument shaft 2133 to continue insertion into the uterus if necessary.

[0056] 22 is an isometric view of a folding cone-shaped sealer 2222 with stepped ridges 2221 or edges extending around the circumference. The distal ring 2223 may be designed to face toward the uterus. The folding cone design allows a seal to form around the distal ring 2223 when an instrument is inserted, and also allows an instrument to be inserted further (distally) if necessary without displacing the sealer 2222.

[0057] 23A-23B show an inverted cup-shaped sealant 2322. The distal ring 2331 faces the uterus and is intended to seal the upper vaginal canal (e.g., resting within the vaginal vault) and around the cervical opening. The curved distal end 2333 can retain a vacuum within the uterus. As shown in FIG. 23B, the sealant 2322 may include multiple helical ridges and / or valleys, which may, for example, allow for an easier and more predictable folding of the sealant 2322. These ridges and valleys may allow the physician to gently remove the device without tearing fresh vaginal sutures. Furthermore, these ridges and valleys may aid in device insertion because the sealant 2322 can be twisted and grasped between two fingers, which may improve visibility during placement.

[0058] 24 shows an inverted cup-shaped seal 2422, which is similar to seal 2322, but includes axially extending pleats 2441 to facilitate folding of seal 2422 during insertion. The material used for seal 2422 may be resilient so that it can naturally unfold and return to its cup shape when the folding force is released (e.g., after insertion).

[0059] FIG. 25 shows a cup-shaped seal 2522, which is similar to seal 2322 except that the distal end 2551 flares outward slightly.

[0060] 26A-26B show sealant 2622, which is similar to sealant 2622, except that it includes a conformable, flared distal end 2661 that can unroll (i.e., roll proximally) on itself (e.g., to accommodate smaller diameters of the vaginal or cervical canal). FIG. 26A shows end 2661 in the flared position, while FIG. 26B shows end 2661 in the proximally rolled position.

[0061] 27 shows a sealant 2722, which includes a central disk 2771 or diaphragm that supports a curved annular structure 2773. The annular structure 2773 is capable of sealing against the vaginal or cervical wall (e.g., at the cervical opening) to retain a vacuum within the uterus.

[0062] FIG. 28 shows a seal 2822 that includes a curved annular structure 2883 that is attached to and supported by a shaft 2833 at its proximal end and is open at its distal end.

[0063] FIG. 29 illustrates another exemplary sealant 2922. The sealant 2922 includes an inflatable bulb 2937 that seals against the shaft 2977 of an insertable instrument. The bulb 2937 may be made of a material that allows the bulb 2937 to be secured against tissue at the opening of the cervix after delivery. In some embodiments, for example, the bulb 2937 may be made of medium durometer silicone or other flexible material. The bulb 2937 may further include a taper 2939 at its distal end to facilitate insertion through the vaginal canal and into the cervix. The overall shape of the bulb 2937 may advantageously provide a seal when a vacuum is drawn into the uterus. In some embodiments, the bulb 2937 may include an annular reinforcing ring 2938 around its periphery. The reinforcing ring may have greater strength than the rest of the bulb 2937, which helps the bulb 2937 maintain its circular or oval shape when pressed against the tissue wall. In some embodiments, the reinforcing ring 2938 may be made of the same material as the rest of the bulb 2937, but may be thicker.

[0064] In some embodiments, the bulb 2937 may be configured to inflate and deflate only with air from the balance chamber 2940. The balance chamber 2940 may be a thin sleeve or balloon made of a very thin, soft durometer material. The balance chamber 2940 may be configured to accept air from the bulb 2937 only when the bulb 2937 is compressed. The size or length of the balance chamber 2940 may be optimized so that the diameter of the balance chamber 2940 does not become larger than the diameter of the bulb 2937 when the bulb 2937 is compressed. A channel between the balance chamber 2940 and the bulb 2937 may allow air to pass back and forth between the balance chamber 2940 and the bulb 2937 as the bulb 2937 returns to its original shape (e.g., after compression applied during instrument insertion is released). Bulb 2937 and balance chamber 2940 are sealed and may advantageously be easy to clean and sterilize if multiple uses are required.

[0065] In another embodiment, bulb 2937 is inflatable via an inflation lumen, hi yet another embodiment, bulb 2937 is inflatable by introducing air through a vent or hole in the proximal end of bulb 2937 (e.g., without a balance chamber).

[0066] The systems, devices, and methods described herein can advantageously stop postpartum bleeding by drawing a vacuum in the uterus after delivery to remove blood from the uterus and assist in uterine contractions.

[0067] In some embodiments, at least a portion of the systems and devices described herein may be transparent to allow visualization of blood and fluids being aspirated from the uterus.

[0068] Any of the devices described herein may be used to apply a continuous vacuum within the bleeding uterus for 1 to 24 hours or less. In some embodiments, the uterus may be kept isobaric by the application of the vacuum. In some embodiments, bleeding may cease in less than 1 hour (e.g., in less than 30 minutes, or in less than 20 minutes, or in less than 5 minutes, or in less than 2 minutes).

[0069] Any of the devices described herein can be used without a separate sealing member, i.e., the uterus can be sealed by tissue sealing directly around the elongate body or shaft.

[0070] Any of the instruments described herein may include a distal tip with soft, rounded edges to prevent trauma to body tissue during insertion.

[0071] Any of the instruments described herein may have a vacuum hole at its distal tip (e.g., aligned with the centerline through the vacuum lumen and / or aligned with the centerlines of the two lumens). Such a vacuum hole can advantageously aid in accessing blood and clots near the tip and / or facilitate ease of cleaning (e.g., with a wire brush) up to the tip of the instrument.

[0072] Any of the devices described herein may be flexible to conform to local anatomy.

[0073] Any of the devices described herein may be more flexible along a first axis than along a second axis. For example, the device may be more flexible along an axis perpendicular to the coronal plane than along an axis perpendicular to the sagittal plane, which may advantageously help the device conform to the natural upward angle of the uterus. Alternatively, any of the devices described herein may be equally flexible along an axis perpendicular to the coronal plane and an axis perpendicular to the sagittal plane, which may allow, for example, the device to be placed within the uterus without regard to orientation.

[0074] It will be appreciated that any feature described herein with respect to one embodiment may replace, or be used in addition to, any element described herein with respect to another embodiment.

[0075] As used herein, when a feature or element is referred to as being "on" another feature or element, the feature or element may be directly adjacent to the other feature or element, or there may be intervening features and / or elements. Conversely, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features and / or elements. It should also be understood that when a feature or element is referred to as being "connected," "attached," or "coupled" to another feature or element, the feature or element may be directly connected, attached, or coupled to the other feature or element, or there may be intervening features or elements. Conversely, when a feature or element is referred to as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements. The features and elements so described or illustrated may be described or illustrated with respect to one embodiment, but may also apply to other embodiments. Also, as will be understood by those skilled in the art, when a structure or feature is referred to as being located "adjacent" to another feature, the reference may include portions that overlap or underlie the adjacent feature.

[0076] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the present invention. For example, as used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly contradicts otherwise. Furthermore, it should be understood that the words "comprises" and / or "comprising," when used herein, specify the presence of stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ."

[0077] Spatially relative terms such as "under," "below," "lower," "over," "upper," and the like may be used herein for ease of description when describing the relationship of one element or feature to another, as shown in the figures. It should be understood that these spatially relative terms are intended to encompass other orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures were inverted, an element described as being "under" or "beneath" another element or feature would then be oriented "over" that other element or feature. Thus, for example, the term "under" can encompass both an orientation of "over" and "under." The device may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein interpreted accordingly. Similarly, terms such as "upwardly," "downwardly," "vertical," "horizontal," etc. are used herein for descriptive purposes only, unless otherwise specified.

[0078] The terms "first" and "second" may be used herein to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element may be referred to as a second feature / element below, and similarly, a second feature / element may be referred to as a first feature / element below, without departing from the teachings of the present invention.

[0079] Throughout this specification and the claims that follow, unless otherwise stated, the term "comprise" and its variations, "comprises," "comprising," etc., mean that various components may be used in conjunction with one another in methods and articles (e.g., devices and method-containing compositions and apparatuses). For example, the word "comprising" should be understood to imply the inclusion of all stated elements or steps, but not the exclusion of any other elements or steps.

[0080] As used in this specification and claims, including in the examples, and unless otherwise specified, any numerical value may be read as if preceded by the word "about" or "approximately," even if the word is not explicitly present. The words "about" or "approximately," when describing a size and / or location, may be used to indicate that the stated value and / or location falls within a reasonable expected range of values ​​and / or locations. For example, a numerical value may be ±0.1% of the stated value (or range of values), ±1% of the stated value (or range of values), ±2% of the stated value (or range of values), ±5% of the stated value (or range of values), ±10% of the stated value (or range of values), or other such values. Any numerical range described herein is intended to encompass all subranges subsumed therein.

[0081] While various exemplary embodiments have been described above, any of several modifications may be made to the various embodiments without departing from the scope of the present invention, as set forth in the claims. For example, the order in which the various described method steps are performed may often be changed in alternative embodiments, and in some alternative embodiments, one or more method steps may be skipped altogether. Optional features of the various device and system embodiments may be included in some embodiments and not included in other embodiments. Accordingly, the foregoing description has been intended primarily for illustrative purposes and should not be construed as limiting the scope of the present invention, as set forth in the claims.

[0082] The examples and specific examples contained herein are illustrative, not limiting, of specific embodiments in which the present subject matter may be practiced. As noted, other embodiments may be utilized or derived, and structural or logical substitutions or changes may be made without departing from the scope of the present disclosure. Such embodiments of the present subject matter may be referred to individually herein or collectively in the language of "the present invention," which is merely for convenience and is not intended to intentionally limit the scope of the present application to any single invention or inventive concept, even if more than one is actually disclosed. Thus, while specific embodiments have been shown and described herein, any configuration designed to achieve the same purpose may be substituted for the specific embodiment shown. The present disclosure is intended to encompass all adaptations or variations of various embodiments. Combinations of the above-described embodiments, as well as other embodiments not specifically described herein, will become apparent to those skilled in the art upon reviewing the above description.

Claims

1. an elongate body configured to be connected to a vacuum source; a flexible loop-shaped portion attached to the elongate body and configured to be placed within a uterus, the flexible loop-shaped portion including a plurality of holes in an inner periphery thereof, and activation of the vacuum source configured to draw a vacuum through the plurality of holes to collapse the uterus when the elongate body is inserted into the uterus; and a shield having an edge that folds around an outer periphery of the looped portion and extends radially inward relative to the flexible looped distal portion, the shield configured to prevent tissue from blocking the plurality of holes when a vacuum is applied; an inflatable seal attached to the elongate body and configured to seal against the uterus; Bleeding prevention devices including:

2. The bleeding prevention device of claim 1 , wherein the flexible loop portion is configured to collapse upon delivery and self-expand into an expanded loop shape.

3. The bleeding prevention device of claim 1 , wherein the shield extends around 270-320 degrees of the circumference of the flexible looped distal portion.

4. 10. The bleeding prevention device of claim 1, wherein the shield extends radially inward a distance of 0.02 to 0.020 inches.

5. The bleeding prevention device of claim 1 , wherein the plurality of holes comprises 10 to 20 holes.

6. The bleeding prevention device of claim 1 , wherein the sealant has a disk-shaped central portion and tapered proximal and distal ends.

7. The bleeding prevention device of claim 1 , further comprising a valved port in fluid communication with the elongate body, the valved portion configured to provide inflation fluid to the inflatable seal.

8. The bleeding prevention device of claim 7 , wherein the valve comprises a check valve.

9. a first elongated tube having a first central channel; a second elongated tube having a second central channel, the second elongated tube joined to and parallel to the first elongated tube, thereby forming an axial valley between the first and second elongated tubes; a connector configured to connect the first and second central channels to a vacuum source; a plurality of holes disposed along the valleys, each of the plurality of holes extending from an outer surface of the device and communicating with both the first central channel and the second central channel, the plurality of holes being configured such that activation of the vacuum source draws a vacuum through the plurality of holes to deflate the uterus when the device is inserted into the uterus; Bleeding prevention devices including:

10. The bleeding prevention device according to claim 9 , wherein each of the plurality of holes has an elongated shape along the valley.

11. The bleeding prevention device according to claim 9 , wherein each of the plurality of holes has a circular shape along the valley.

12. 10. The bleeding prevention device of claim 9, further comprising a sealant disposed along said first and second elongated tubes.

13. 13. The bleeding prevention device of claim 12, wherein the sealant has a disk-shaped central portion and tapered proximal and distal ends.

14. 10. The bleeding prevention device of claim 9, wherein said valleys are 0.02 to 0.2 inches deep.

15. The bleeding prevention device according to claim 9, wherein the angle between the valleys is between 10 and 80 degrees.

16. 10. The bleeding prevention device of claim 9, wherein the ratio of the width of the device to the height of the device is between 1.4 and 2.3, and the width and height are perpendicular to the axial valley.

17. 10. The bleeding prevention device of claim 9, wherein the ratio of the height of the device to the width of the device is between 1.4 and 2.3, and the width and height are perpendicular to the axial valley.

18. 10. The bleeding prevention device of claim 9, wherein the ratio of the height of the device to the width of the device is about 1, and the width and height are perpendicular to the axial valley.

19. 10. The bleeding prevention device of claim 9, wherein each of the plurality of holes extends completely through the valley from the outer surface to an opposite second outer surface.

20. The bleeding prevention device of claim 9 further comprising a tapered distal tip.

21. an elongate body configured to be connected to a vacuum source, the elongate body having a plurality of holes, and activation of the vacuum source configured to draw a vacuum through the plurality of holes to collapse the uterus when the elongate body is inserted into the uterus; a seal attached to the elongate body and configured to seal the uterus, the seal including a proximal ring and a distal skirt and configured to have a generally conical shape; and Bleeding prevention devices including:

22. 22. The bleeding prevention device of claim 21, wherein the sealant is proximal to the hole.

23. 22. The bleeding prevention device of claim 21, wherein the angle of the skirt relative to the elongate body is between 30 and 60 degrees.

24. 22. The bleeding prevention device according to claim 21, wherein the ring has a diameter of 2 to 10 mm.

25. 22. The bleeding prevention device of claim 21, wherein the ring is stiffer than the skirt.

26. 22. The bleeding prevention device of claim 21, wherein the ring is thicker than the skirt.

27. 22. The bleeding prevention device of claim 21, wherein the skirt has a thickness of 1 to 1.5 mm.

28. 22. The bleeding prevention device of claim 21, wherein the ring lies in a plane generally perpendicular to a longitudinal axis of the elongate body.

29. 22. The bleeding prevention device of claim 21, wherein the proximal ring is configured to press against tissue of the vaginal canal or cervical wall.

30. 22. The bleeding prevention device of claim 21, wherein the seal is configured to invert when the elongate body is pulled proximally.

31. 31. The bleeding prevention device of claim 30, wherein the skirt is continuous with an outermost diameter portion of the proximal ring when the seal is inverted.

32. 22. The bleeding prevention device of claim 21, wherein the thickness of the skirt varies from its proximal end to its distal end.

33. 22. The bleeding prevention device of claim 21, wherein the skirt has a uniform thickness from its proximal end to its distal end.

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