Postpartum uterine bleeding device

Abstract

A hemostatic device includes an elongated body, a flexible annular portion, a shield and an inflatable seal. The elongated body is configured to be connected to a vacuum source. The flexible annular portion is connected to the elongated body and includes a plurality of holes on the inner circumference of the flexible annular portion. The flexible annular portion is configured to be placed in the uterus. When the elongated body is inserted into the uterus, activation of the vacuum source is configured to draw a vacuum through the plurality of holes to contract the uterus. The shield is folded around the outer circumference of the annular portion, and the shield has an edge extending radially inward relative to the flexible annular distal portion. The shield is configured to prevent tissue from blocking the plurality of holes when a vacuum is applied. The inflatable seal is connected to the elongated body and configured to seal the uterus.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 62 / 861,233, filed June 13, 2019, entitled "DEVICE FOR POSTPARTUM UTERINE BLEEDING," 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, filed December 10, 2018, entitled "DEVICE FOR POSTPARTUM UTERINE BLEEDING," the entire contents of which are incorporated herein by reference.

[0003] This application also relates to U.S. Patent Publication No. 2019 / 083132, entitled “Uterine Bleeding Control System and Method,” filed on July 13, 2018, the entire contents of which are incorporated herein by reference.

[0004] This application also relates to U.S. Patent Publication No. 2018 / 0055523, entitled “Uterine Bleeding Control System and Method,” filed on August 22, 2017, the entire contents of which are incorporated herein by reference.

[0005] Reference Addition

[0006] 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 Art

[0007] Postpartum hemorrhage, defined as excessive blood loss after childbirth, is the leading cause of maternal mortality worldwide, claiming the lives of more than 125,000 mothers each year. Uncontrolled postpartum hemorrhage may require multiple blood transfusions and, in severe cases, may lead to a hysterectomy or death. Therefore, it is desirable to control this postpartum hemorrhage at the onset, if possible. In approximately 80% of cases, the cause of postpartum hemorrhage is uterine atony, the inability of a woman's uterus to contract after childbirth. Risk factors for uterine atony include prolonged labor, preeclampsia, and multiparity. Therefore, there is a need for a system that can rapidly induce uterine contractions, thereby reducing or completely stopping uterine bleeding. Summary of the Invention

[0008] In general, in one embodiment, a hemostatic device includes an elongated body, a flexible annular portion, a shield, and an inflatable seal. The elongated body is configured to be connected to a vacuum source. The flexible annular portion is connected to the elongated body and includes a plurality of holes on an inner circumference of the flexible annular portion. The flexible annular portion is configured to be placed in the uterus. When the elongated body is inserted into the uterus, activation of the vacuum source is configured to draw a vacuum through the plurality of holes to contract the uterus. The shield is folded around the outer circumference of the annular portion, and the shield has an edge extending radially inward relative to the flexible annular distal portion. The shield is configured to prevent tissue from blocking the plurality of holes when a vacuum is applied. The inflatable seal is connected to the elongated body and configured to seal the uterus.

[0009] This embodiment and other embodiments may include one or more of the following features. The flexible annular portion may be configured to be collapsible for delivery and self-expandable to an expanded annular shape. The shield may extend around 270°-320° of the circumference of the flexible annular distal portion. The shield may extend radially inward a distance of between 0.02" and 0.020". The plurality of holes may include 10-20 holes. The seal may have a disc-shaped central portion, a tapered proximal end, and a tapered distal end. The device may also include a valved port in fluid communication with the elongated body. The valved portion may be configured to provide inflation fluid to the inflatable seal. The valve may include a check valve.

[0010] In general, in one embodiment, a hemostatic device includes a first elongated tube, a second elongated tube, a connector, and a plurality of apertures. The first elongated tube has a first central passage. The second elongated tube has a second central passage, the second elongated tube being connected to and parallel to the first elongated tube to form an axial gap between the first and second elongated tubes. The connector is configured to connect the first and second central passages to a vacuum source. The plurality of apertures are positioned along the gap. Each of the plurality of apertures extends from an outer surface of the device and connects to the first and second central passages. When the device is inserted into a uterus, activation of the vacuum source is configured to draw a vacuum through the plurality of apertures to contract the uterus.

[0011] This embodiment and other embodiments may include one or more of the following features. Each of the plurality of apertures may have an elongated shape along the slit. Each of the plurality of apertures may have a circular shape along the slit. The hemostatic device may further include a seal positioned along the first elongated tube and the second elongated tube. The seal may have a disc-shaped central portion, a tapered proximal end, and a tapered distal end. The slit may have a depth between 0.02" and 0.2". The angle of the slit may be between 10 degrees and 80 degrees. The ratio of the width of the device to the height of the device may be between 1.4 and 2.3, wherein the width and height are perpendicular to the axial slit. The ratio of the height of the device to the width of the device may be between 1.4 and 2.3, wherein the width and height are perpendicular to the axial slit. The ratio of the height of the device to the width of the device may be approximately 1, wherein the width and height are perpendicular to the axial slit. Each of the plurality of apertures may extend from the outer surface completely through the slit to the opposing second outer surface. The hemostatic device may further include a tapered distal tip.

[0012] In general, in one embodiment, a hemostatic device includes an elongated body and a sealing member. The elongated body is configured to be connected to a vacuum source, the elongated body having a plurality of apertures. When the elongated body is inserted into the uterus, activation of the vacuum source is configured to draw a vacuum through the plurality of apertures to contract the uterus. The sealing member is coupled to the elongated body and configured to seal the uterus. The sealing member includes a proximal ring and a distal skirt and is configured to have a generally conical shape.

[0013] This embodiment and other embodiments may include one or more of the following features. The seal may be proximal to the aperture. The angle of the skirt relative to the elongated body may be between 30 and 60 degrees. The ring may have a diameter of 2-10 mm. The ring may be harder than the skirt. The ring may be thicker than the skirt. The thickness of the skirt may be 1-1.5 mm. The ring may be located in a plane that is substantially perpendicular to the longitudinal axis of the elongated body. The proximal ring may be configured to press against tissue of the vaginal cavity or cervical wall. The seal may be configured to flip when the elongated body is pulled proximally. When the seal flips, the skirt may be attached to the outermost diameter of the proximal ring. The thickness of the skirt may vary from the proximal end to the distal end of the skirt. The thickness of the skirt may be uniform from the proximal end to the distal end of the skirt. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The novel features of the present 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 gained by reference to the following detailed description, which illustrates exemplary embodiments in which the principles of the present invention are utilized, and the accompanying drawings, which are:

[0015] Figure 1A An exemplary system for controlling uterine bleeding is illustrated.

[0016] Figure 1B Another exemplary system for controlling uterine bleeding is illustrated.

[0017] Figure 2A is a perspective side view of an exemplary insertable device for controlling uterine bleeding.

[0018] Figure 2B yes Figure 2A Another side perspective view of the insertable device.

[0019] Figure 2C yes Figure 2A Another side perspective view of the insertable device.

[0020] Figure 2D yes Figure 2A A three-dimensional view of a protective body of an insertable device.

[0021] Figure 2E yes Figure 2A A cross-sectional view of a protective body of an insertable device.

[0022] Figure 2F yes Figure 2A A partial enlarged view of the insertable device.

[0023] Figure 2G yes Figure 2A A flattened view of the inner circumference of the annular portion of the insertable device.

[0024] Figure 2H yes Figure 2A Side view of a seal of an insertable device.

[0025] Figure 2I yes Figure 2A Cross-sectional view of the proximal end of the insertable device.

[0026] Figure 3 is a perspective view of another exemplary insertable device for controlling uterine bleeding.

[0027] Figure 4 is a perspective view of another exemplary insertable device for controlling uterine bleeding.

[0028] Figure 5is a perspective view of another exemplary insertable device for controlling uterine bleeding.

[0029] Figure 6A is a cross-sectional view of another device used to control uterine bleeding.

[0030] Figure 6B Shown Figure 6A Side view of the insertable device.

[0031] Figure 7 is a cross-sectional view of another device used to control uterine bleeding.

[0032] Figure 8 is a cross-sectional view of another device used to control uterine bleeding.

[0033] Figure 9 is a cross-sectional view of another device used to control uterine bleeding.

[0034] Figure 10 is a cross-sectional view of another device used to control uterine bleeding.

[0035] Figure 11 is a cross-sectional view of another device used to control uterine bleeding.

[0036] Figure 12A is a perspective view of another exemplary insertable device for controlling uterine bleeding.

[0037] Figure 12B yes Figure 12A A cross-sectional view of an insertable device.

[0038] Figure 13A is a perspective view of another exemplary insertable device for controlling uterine bleeding.

[0039] Figure 13B yes Figure 13A A cross-sectional view of an insertable device.

[0040] Figure 13C is a perspective view of several different insertable devices used to control uterine bleeding.

[0041] Figure 14 An exemplary distal tip of an insertable device for controlling uterine bleeding is shown.

[0042] Figure 15A Another exemplary distal tip of an insertable device for controlling uterine bleeding is shown.

[0043] Figure 15B Shown Figure 15A The distal end of the lipophilic membrane presses against the tissue.

[0044] Figure 16 is a side view of another exemplary insertable device for controlling uterine bleeding.

[0045] Figure 17A Shown is a foam seal on an exemplary insertable device for controlling uterine bleeding.

[0046] Figure 17B Shown Figure 17A The foam seal is in a compressed configuration.

[0047] Figure 18 is a side view of another exemplary seal for use with an insertable device for controlling uterine bleeding.

[0048] Figure 19 is a side view of another exemplary seal for use with an insertable device for controlling uterine bleeding.

[0049] Figure 20 is a top view of another exemplary seal for use with an insertable device for controlling uterine bleeding.

[0050] Figure 21 is a side perspective view of another exemplary seal for use with an insertable device for controlling uterine bleeding.

[0051] Figure 22 is a side perspective view of another exemplary seal for use with an insertable device for controlling uterine bleeding.

[0052] Figure 23A is a side perspective view of another exemplary seal for use with an insertable device for controlling uterine bleeding.

[0053] Figure 23B yes Figure 23A A side perspective view of a seal having spiral ridges or valleys.

[0054] Figure 24 is a side perspective view of another exemplary seal for use with an insertable device for controlling uterine bleeding.

[0055] Figure 25 is a side perspective view of another exemplary seal for use with an insertable device for controlling uterine bleeding.

[0056] Figure 26A is a side perspective view of another exemplary seal for use with an insertable device for controlling uterine bleeding.

[0057] Figure 26B yes Figure 26A Side perspective view of the distal end of the seal rolled proximally.

[0058] Figure 27 is a side perspective cutaway view of another exemplary seal for use with an insertable device for controlling uterine bleeding.

[0059] Figure 28 is a cross-sectional view of another exemplary seal for use with an insertable device for controlling uterine bleeding.

[0060] Figure 29 is a cross-sectional view of another exemplary seal for use with an insertable device for controlling uterine bleeding.

[0061] Figure 30A is a cross-sectional view of another exemplary insertable device for controlling uterine bleeding.

[0062] Figure 30B Shown Figure 30A Insertion of the insertable device.

[0063] Figure 30C Shows the reverse Figure 30A Insertable device.

[0064] Figure 30D Shown Figure 30A The insertable device is inverted when the shaft is pulled proximally.

[0065] Figure 31 is a cross-sectional view of another exemplary insertable device for controlling uterine bleeding.

[0066] Figure 32 Retraction of the distal portion of an insertable device for controlling uterine bleeding is shown.

[0067] Figure 33 An exemplary placement of an insertable device for controlling uterine bleeding within the body is shown.

[0068] Figure 34 Shown is a syringe for introducing an inflation fluid into an insertable device for controlling uterine bleeding.

[0069] Figure 35 An exemplary connecting tube of an insertable device for controlling uterine bleeding is shown.

[0070] Figure 36 Shown Figures 12A-12B The depth and angle of the gap of the device.

[0071] Figure 37 Shown Figures 13A-13B The depth and angle of the gap of the device. DETAILED DESCRIPTION

[0072] Described herein are uterine bleeding devices, systems, and methods for generating a vacuum within the postpartum uterine space while simultaneously evacuating blood and / or clots from the postpartum uterine space. The vacuum can advantageously promote physical contraction of the uterine space to induce intrauterine tension, thereby affecting control of bleeding.

[0073] Figure 1A An exemplary system 100 for controlling uterine bleeding is illustrated, according to an embodiment. The system 100 functions to reduce or completely stop uterine bleeding, which may occur after childbirth when a woman experiences uterine atony, a condition in which the uterus cannot contract. Controlling uterine bleeding can significantly reduce the total amount of blood lost from the uterus and can reduce the need for blood transfusions or hysterectomy in women who have given birth. Figure 1A In an embodiment, the system 100 promotes uterine contractions by sealing the opening of the uterus and providing pressure changes within the uterus. Changing the pressure creates a vacuum within the uterus, which produces a uniform mechanical stimulation of the uterine wall to promote tamponade and contraction of the tissue. Figure 1A In an embodiment, system 100 includes an insertable device 105 , a pump 110 , and a collection container 115 .

[0074] Insertable device 105 is configured to be inserted into the uterus to deliver the pressure changes provided by pump 110. Figure 1A In one embodiment, the insertable device 105 is delivered transvaginally (through the vagina) such that the distal portion 120 of the insertable device 105 is positioned within the uterus while the proximal portion 125 of the insertable device 105 remains outside the uterus. The distal portion 120 can have a flexible structure to conform to the anatomical structure of the uterus. A seal 122 between the distal portion 120 and the proximal portion 125 can form a seal at the opening of the uterus. The proximal portion 125 of the insertable device 105 is connected to the pump 110. Figure 33 An exemplary positioning of seal 122 at cervical opening 186 within vaginal cavity 189 is shown such that distal portion 120 is positioned within uterus 188. In some embodiments, insertable device 105 can have a sheath that facilitates insertion of insertable device 105 into the uterus and can additionally prevent premature connection of airflow from pump 110 to the uterus.

[0075] The pump 110 creates pressure changes that create a vacuum in the uterus. Figure 1AIn some embodiments, the pump 110 is connected to the proximal portion 125 of the insertable device 105. In some embodiments, a connecting tube 130 is connected to the proximal portion 125 and the pump 110, thereby connecting the pump 110 and the insertable device 105. In some embodiments, the collection chamber 115 is positioned along the connecting tube 130 between the pump 110 and the proximal portion 125 to prevent blood from entering the pump 110, as further described 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 opposite direction. An exemplary connecting tube 130 is shown in FIG. Figure 35 The connector 147 on the tube 130 is configured to mate with the connector 148 on the insertable device 105 .

[0076] When activated, pump 110 generates an airflow that is delivered to the uterus through the channels and / or openings of insertable device 105. Typically, a vacuum pump is configured to remove molecules from a sealed volume, leaving a partial vacuum. Because the uterus is sealed by placement device 105 (e.g., by seal 122), the airflow generated by pump 110 reduces the pressure within the uterus, causing the uterine pressure to drop below the atmospheric pressure outside the uterus (e.g., to a pressure less than 1 atmosphere). The vacuum ensures that airflow travels in a single direction from the uterus and through insertable device 105 toward pump 110. In some embodiments, pump 110 can be configured to provide a vacuum pressure of 60-150 mmHg, e.g., 70-90 mmHg, e.g., approximately 80 mmHg. The vacuum within the uterus promotes tamponade, arterial vasoconstriction, and contractile movement of the uterine wall by providing uniform mechanical stimulation. In addition, generating a vacuum can remove biological material within the uterus. Biological material may include blood, tissue, etc. Pump 110 can be electrically (automatically) operated or manually operated. In embodiments where the pump 110 is manually operated, the pump 110 can create a vacuum within the uterus when in a first state, and in a second state, the pump 110 can draw biological material into the collection container 115 while maintaining the vacuum within the uterus.

[0077] The collection container 115 collects the biological material removed from the uterus. Figure 1A As shown, the collection container 115 can be connected in series with the pump 110. The proximal portion 125 of the insertable device 105 is connected to the collection container 115 and the pump 110 via a connecting tube 130. In this embodiment, when the pump 110 is activated, a fluid (e.g., air, biological material, etc.) flows through the connecting tube 130 to the pump 110. The biological material is removed from the connecting tube 130 and collected in the collection container 115 before reaching the pump 110. Collecting biological material from the uterus can allow the user to monitor and measure the amount of blood loss due to uterine bleeding. Monitoring blood loss also allows the user to determine whether, when, and / or to what extent uterine contractions have occurred.

[0078] In some embodiments, in addition to monitoring and / or treating postpartum hemorrhage, system 100 can also be used to prevent postpartum hemorrhage. For example, system 105 can be used by any woman after childbirth to help her uterus contract. The flexibility of insertable device 105 allows a healthcare provider (e.g., a nurse, doctor, surgeon, etc.) to palpate the uterine tissue in the woman's abdomen to detect if and / or when the uterus contracts. Furthermore, the flexibility of insertable device 105 allows it to be retracted, bent, and positioned during other vaginal wall or tissue repair surgeries. Figure 32 The distal portion 120 of the device 105 is shown being manually retracted for insertion into the uterus.

[0079] In some embodiments, the insertable device 105 can be configured to be inserted into the vaginal cavity or cervical canal (e.g., the upper vaginal cavity, the cervical external OS, or tissue adjacent thereto), such that the insertable device 105 remains outside the uterus. Seal 122 can form a seal between the vaginal or cervical introitus and the uterus. This seal allows the airflow of pump 110 to reduce the pressure within the uterus, causing the uterine pressure to drop below the atmospheric pressure outside the uterus and creating a vacuum within the uterus. As previously described, this promotes tamponade, arterial vasoconstriction, and contractile movement of the uterine wall by providing uniform mechanical stimulation.

[0080] Figure 1B A system 200 for controlling uterine bleeding according to other embodiments is illustrated. System 200 is similar to system 100, except that system 200 does not include a separate collection chamber. Thus, system 200 includes an insertable device 105 and a pump 110. A proximal portion 125 of the insertable device 105 is connected to the pump 110 via a connecting tube 130. In this embodiment, the collection container can be integrated with the pump 110 such that a fluid (e.g., air, biological material, etc.) flows through the connecting tube 130 into the pump 110, where the biological material is collected into a separate compartment of the pump 110. The compartment for collecting the biological material can be detachable from the pump 110. This can help a healthcare provider monitor the amount of biological material collected.

[0081] Figures 2A-2I 105. An enlarged view of another embodiment of an insertable device 205 similar to device 105 is shown in FIG. Insertable device 205 includes a proximal portion 225, a distal portion 220, and a seal 222 between the proximal portion 225 and the distal portion 220.

[0082] The proximal portion 225 includes an elongated body 238 or shaft that houses the vacuum channel 231, a connector 237 for connecting the channel 231 to a pump, an inflation channel 236, and a valved port 239 for introducing an inflation medium into the seal 222 through the inflation channel 236. In some embodiments, the inflation channel 236 and the vacuum channel 231 can extend adjacent to and / or parallel to each other. The valve in the valved port 239 can be, for example, a check valve that prevents fluid flow when not engaged with a syringe and opens to allow fluid to pass when engaged with a syringe. Figure 34 An exemplary syringe 234 is shown that is configured to be insertable into valved port 239 to introduce inflation medium.

[0083] Return Reference Figures 2A-2I The distal portion 220 includes a flexible annular segment 223 that is configured to contract for delivery to the uterus and then self-expand to a ring shape to conform to the uterus. Furthermore, the annular segment 223 includes an inner annular portion 232 and a shield 233. The inner annular portion 232 is continuously and fluidically connected to the proximal portion 225. The inner annular portion 232 includes a plurality of holes 229 on its inner circumference to provide a vacuum through the plurality of holes 229 (via connection to the vacuum channel 231). For example, there may be 10-30 holes 229, such as 20 holes 229. If one or more holes become blocked during use, the plurality of holes 229 can help provide redundancy. The shield 233 can conform to the outer circumference of the inner annular portion 232 and fold around the outer circumference of the inner annular portion 232. For example, the shield 233 can extend 270°-320° around the outer circumference of the inner annular portion 232. Additionally, the edge of the shield 233 may extend radially inward relative to the inner annular portion 232 by a distance of 0.02" to 0.20", e.g., 0.04" to 0.15", e.g., approximately 0.08". The overhanging edge of the shield 233 may advantageously help protect the aperture 229 from being blocked by tissue when vacuum is drawn therethrough.

[0084] The seal 222 can have a disc-shaped central portion 292 with a tapered proximal end 293a and a distal end 293b. The seal 222 can be, for example, an inflatable balloon that is inflated through a valved port 239. A volume of fluid, e.g., 30-200cc, e.g., 40-120cc, e.g., approximately 60cc, can be used to inflate the seal 222.

[0085] In some embodiments, an insertable device (e.g., for use with system 200) can have a different shape (i.e., not annular) and / or can be used without a separate shield. Figure 3 -13 shows a variety of different exemplary insertable devices. Figure 3The device of -13 can be designed to allow fluid to be drawn around it (through multiple different holes) while having ridges and / or lips to prevent tissue and large clots from getting close enough to the holes to block flow. Multiple holes can advantageously allow redundancy in the event that some holes become blocked and distribute the vacuum load across the holes to prevent the holes from becoming blocked by tissue and / or clots. For example, Figure 3 -13 can be extruded from a single material (e.g., a thermoplastic material such as polyurethane). This single extrusion can advantageously reduce design costs while providing flexibility and rigidity. In some embodiments, Figure 3 The device shown in -13 can be made from multiple extrusions and / or molded parts of different hardness that are welded together to achieve the optimal design. The holes in the extrusions can be formed by, for example, drilling, punching, laser or water jet cutting.

[0086] Figure 3 An exemplary insertable device 305 is shown. The device 305 includes an elongated shaft 333 that is substantially linear (i.e., not annular). A plurality of holes 301 extend in the sidewall of the shaft 333 from a central vacuum channel 307 to the exterior thereof (i.e., for applying a vacuum therethrough). Wings or ridges 331 extend radially along the shaft 333 and along the length of the shaft 333. The ridges 331 are angled relative to each other to form substantially V-shaped grooves therebetween that extend along the length of the shaft 333. The outermost edges of the ridges 331 can be rounded and / or atraumatic. In some embodiments, and Figure 3 As shown in FIG, there can be four ridges 331 positioned so that they give the device 305 a substantially "X"-shaped cross-sectional shape. Additionally, the holes 301 can be located between the ridges 331 (e.g., at the base or apex of the V-shaped grooves). The ridges 331 can help prevent the holes 301 from aspirating tissue, thereby keeping the holes 301 clear for applying a vacuum and removing blood from the uterus. Additionally, the holes 301 can be positioned at alternating and / or different locations along the longitudinal axis of the shaft 333 (i.e., the holes in adjacent grooves can be at different axial locations) to both help prevent tissue clogging and maintain the stability of the device 305.

[0087] Figure 4 Another exemplary insertable device 405 is shown. Like device 305, device 405 includes a substantially linear shaft 433 having a plurality of holes 401 extending through its sidewall. The holes 401 can be randomly positioned along the shaft 433. Additionally, device 405 can include ridges thereon and / or raised features surrounding the holes 401 to help prevent tissue from obstructing the holes 401 when a vacuum is applied.

[0088] Figure 5Another exemplary insertable device 505 is shown. Device 505 is similar to device 305, but shaft 533 includes only three longitudinal ridges 531 with holes 501 between ridges 531.

[0089] Figure 11 Another exemplary device 1105 is shown that is similar to device 505, but includes a sharp knife-like edge 1111 extending radially from each ridge 1131. The edge 1111 is curved along the circumference of the device 1105 to provide a smooth rotation during torsion or rotation (e.g., during rotation). Figure 11 clockwise in the middle) to help cut through the clot.

[0090] Figures 6A-6B Another exemplary insertable device 605 is shown. Device 605 is similar to device 305, except that device 605 includes two parallel ridges 631a, 631b on each of the four sides of shaft 633. As shown, each pair of ridges 631a, 631b can be approximately 90 degrees to the adjacent pair of ridges. Aperture 601 can extend in shaft 633 between individual ridges 631a, 631b of each pair of parallel ridges 631a, 631b. In addition, in some embodiments (and as Figures 6A-6B ), the holes 601 may be through holes extending from one side of the shaft 633 to the other through the vacuum channel 607. However, adjacent holes 601 may be offset along the longitudinal axis (as shown in FIG. Figure 6B as shown) to maintain the integrity of device 605.

[0091] Figure 7 Another exemplary insertable device 705 is shown that is similar to device 605, except that device 705 includes only three pairs of ridges 731a, 731b (each pair of ridges is positioned approximately 120 degrees from an adjacent pair of ridges). Aperture 701 can similarly be positioned in shaft 733 between individual ridges 731a, 731b of each pair of ridges 731a, 731b.

[0092] Figure 8 Another exemplary insertable device 805 is shown that is similar to device 605, except that device 805 includes only two pairs of ridges 831a, 831b (e.g., positioned approximately 180 degrees from each other). The hole 801 in the shaft 833 between each of the paired ridges 831a, 831b can be a through hole extending from one side of the device through the central vacuum channel 807 to the other side. Since the insertable device 805 has only two sets of ridges approximately 180 degrees apart from each other, it can be substantially flat. This design can provide enhanced flexibility or bending in one direction (i.e., along the minor axis) relative to another direction (i.e., along the major axis).

[0093] Figure 9Another exemplary insertable device 905 is shown. Device 905 is substantially linear and includes a shaft 933 having a plurality of apertures 901 extending from a central vacuum channel 907 in the sidewall of shaft 933 to the exterior thereof (i.e., for applying vacuum through apertures 901). Protrusions 991 extend radially from shaft 933 along its length. Device 905 includes four protrusions positioned substantially 90 degrees apart from one another. Furthermore, the outermost ends of protrusions 991 may each include a circumferential extension 995 having a crescent-shaped cross-section. Extensions 995 extend circumferentially around device 905 (i.e., to form a substantially atraumatic, circular outer profile of device 905). The open spaces 993 between extensions 995 and between protrusions 991 and extensions 995 can advantageously allow vacuum to reach apertures 901, while the large circumferential coverage of extensions 995 can prevent tissue from collapsing onto aperture 901. In some embodiments, extension 995 can include a sharp inner edge 997 so that twisting of device 905 in a clockwise or counterclockwise direction can help cut through the clot.

[0094] Figure 10 Another exemplary insertable device 1005 is shown that is similar to device 905 , except that device 1005 includes only three protrusions 1091 (eg, positioned substantially 120 degrees from each other).

[0095] Figures 12A-12B Another exemplary insertable device 1205 is shown in FIG. The device 1205 includes a substantially linear shaft 1233 and includes two tubular portions 1212a, 1212b extending side by side in parallel. Each tubular portion 1212a, 1212b includes a vacuum channel 1207a, 1207b extending therein. The junction between the two tubular portions 1212a, 1212b creates a longitudinal slit 1221a, 1221b therebetween, and the aperture 1201 can be positioned in the longitudinal slit 1221a, 1221b (i.e., connected to the two vacuum channels 1207a, 1207b). Positioning the aperture 1201 within the longitudinal slit 1221a, 1221b can advantageously help ensure that tissue is not pulled into the aperture 1201. In some embodiments, the diameter d of each vacuum channel 1207a, 1207b is v The distance d between the vacuum channels 1207a, 1207b may be 3-6 mm, for example 5 mm. b It may be 1-3 mm, such as 1.5 mm, and the diameter of the hole 1201 may be 2-5 mm, such as 3 mm.

[0096] Figures 13A-13CAnother exemplary insertable device 1305 is shown in FIG. Device 1305 is similar to device 1205, except that the tubular portions 1312a, 1312b of shaft 1333 are partially flattened to form elliptical vacuum channels 1307a, 1307b and deeper gaps 1321a, 1321b, and that the aperture 1301 has an elongated cross-section (although it should be understood that the aperture 1301 can similarly have a circular cross-section). In some embodiments (and as Figure 13A As shown), hole 1301 can be a through hole that can extend from one side to the other side. The elliptical orientation can advantageously provide preferential bending. For example, referring to Figure 13B The device 1305 can be inserted into the uterus in a plane defined by the Y direction (i.e., the coronal plane), which is parallel to the delivery table on which the mother lies supine, and then preferentially flexes / bends in the X direction (perpendicular to the coronal plane), which is consistent with the anatomical curve of the uterus.

[0097] refer to Figures 36-37 The gap 1221, 1321 formed between the two tubular members 1212, 1312 of the device 1205, 1305 (or similar devices) can be determined by the depth (d c ) and an angle (α). Angle α is formed by lines intersecting at the apex at or near the base of the slits 1221, 1321. The depth d is determined from the apex of the angle to the top surface of the tubular member 1212, 1312. c . If the device 1205, 1305 is to be reused, the larger the angle α, the easier it is to clean the slit 1221, 1321. However, a larger angle α may also cause the overlying tissue to sag and block the hole at the bottom of the slit 1221, 1321. A smaller angle α makes it more difficult for the overlying tissue to sag and block the hole, but the slit 1221, 1321 with a tighter base is more likely to be blocked by clotted blood. In addition, a narrower slit 1221, 1321 can make the device 1205, 1305 more difficult to clean if it is reused. Therefore, the depth d of the slit 1221, 1321 is c It can be between 0.02" and 0.20", for example, between 0.05" and 0.12". In addition, the angle α of the gaps 1221, 1321 can be 10-80 degrees, for example, 20-65 degrees. These depths d c The angle α can advantageously prevent occlusion of blood and hanging tissue while ensuring that the devices 1205, 1305 can be properly cleaned.

[0098] Figure 13CVariations of device 1305 (1305a-1305j) are shown. Variations 1305a, 1305b, 1305e, and 1305f are flatter than the remaining variations (i.e., the thickness in the y-direction is less than the thickness in the x-direction), such that the hole 1301 extends through the thinner portion. In contrast, variations 1305c, 1305d, 1305g, and 1305h have holes 1301 extending through the thicker portion (because the thickness in the y-direction is greater than the thickness in the x-direction). Having holes 1301 extending through the thicker portion (as in variations 1305c, 1305d, 1305g, and 1305h) can more easily align with the two planes of the uterine surfaces that converge, facilitating drainage of fluid from both planes. In some embodiments, Figures 13A-13C The ratio of the width of the device in the x-direction to the height in the y-direction (or vice versa) may be between 1.4 and 2.3 to provide preferential bending.

[0099] Figure 3 Any of the insertable devices of -13 may have a tapered and / or atraumatic distal tip to ensure that the uterine wall is not damaged during insertion and use. For example, Figure 14 An exemplary distal tip 1461 is shown. The distal tip 1461 can have the same or a softer diameter than the rest of the insertable device (e.g., the shaft of the insertable device). Similarly, the exemplary tip 661 is Figure 6B The tip 661 may have a tapered shape into which the ridge 631 abuts and / or terminates, such that the distal end of the ridge 631 does not directly contact the tissue. Figure 14 and 6B As shown, in some embodiments, the central vacuum channel 1407, 607 can extend along the entire device (including the distal end 1461, 661), for example, to provide an additional vacuum port at the distal end and / or to allow for flushing or cleaning of the device. Figures 15A-15B In some embodiments, the tip 1561 can be a soft dome that can collapse during engagement with the tissue 1515 (see Figures 15A to 15B In some embodiments, the dome end 1561 can be hollow. In other embodiments, the dome end 1561 can include a soft sponge-like material or have webbing molded therein to provide optimized flexibility or softness for engaging with tissue.

[0100] Figure 16Another exemplary insertable device 1605 is shown. Device 1605 includes a proximal bulb structure 1616 and a distal bulb structure 1618. Aperture 1601 (for connection to a vacuum channel) is located in a gap 1619 formed between the proximal and distal bulb structures 1616, 1618. Bulb structures 1616, 1618 can be made of a soft material (e.g., foam or webbing) to provide sufficient constriction for insertion through the cervix, but sufficient rigidity to prevent tissue from blocking aperture 1601 when vacuum is applied.

[0101] Various seal designs can be used with the anti-bleeding devices and systems described herein (e.g., system 100 or 200 and / or Figure 2A-13C 17-30 illustrate a number of different exemplary seal designs that may be used with any of the devices described herein.

[0102] Figures 17A-17B An insertable device 1705 is shown having a seal 1722. The seal 1722 can be made of a thin, compliant sheath 1719 having a foam material 1771 therein. A vent or slit 1717 can extend through the proximal end of the sheath 1719 to allow air to enter the foam material 1771 to expand the seal 1722. Figure 17B As shown, seal 1722 can be deflated (e.g., by squeezing a hand or finger before insertion into the body) and then expanded once inside the body to conform to the anatomy. In some embodiments, seal 1722 can be connected to an inflation lumen (e.g., extending parallel to the vacuum lumen described above) to assist in the inflation of seal 1722. In some embodiments, the exposure of slit 1717 at the proximal end of seal 1722 can provide sufficient air passageway such that an inflation lumen is unnecessary.

[0103] Figure 18 18 is a side view of an umbrella-shaped (or conical) diaphragm seal 1822, with the shaft 1833 of the insertable device extending upwardly in the middle of the seal 1822. 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 the cervical opening, or the outer ring 1882 can seal against the tissue of the vaginal cavity or cervical canal to allow a vacuum to be created within the uterus. In some embodiments, the outer ring 1882 can be pressed against the tissue of the vaginal cavity or cervical wall and / or be in continuous radial contact with the tissue of the vaginal cavity or cervical wall to maintain the seal within the uterus.

[0104] Figures 30A-30DInsertable device 3005 is shown, similar to insertable device 1822, including an umbrella-shaped (or tapered) septum seal 3022, with an axis 3033 of insertable device 3005 extending upwardly from the middle of seal 3022. A distal skirt 3081 of seal 3022 has a smaller angle α relative to axis 3033 than seal 1822 (see FIG. Figure 30A , for example, angle α can be 30 degrees to 60 degrees, such as approximately 45 degrees. The proximal ring 3082 can be a heavy or rigid ring (e.g., a solid polymer ring having a diameter of 2-10 mm, such as approximately 5 mm). The rigid ring 3082 can advantageously maintain a circular or oval shape despite tissue contraction around the ring 3082. The distal skirt 3081 can be further thicker than the skirt of the seal 1822 (e.g., the wall of the skirt 3081 can have a thickness of 1-1.5 mm, such as approximately 1.2 mm).

[0105] refer to Figure 30B When inserted into the vaginal cavity or cervical canal, the ring 3082 can be placed against the tissue 3031 of the vaginal or cervical wall to seal the device thereto. The rigidity of the ring 3082 can advantageously help maintain the shape of the ring 3082 in a plane (i.e., in a plane 3035 perpendicular to the longitudinal axis 3037 of the shaft 3033). The thick skirt 3081 is in tension when placed and can further help the ring 3082 remain in place (in the plane 3035 perpendicular to the longitudinal axis 3037), preventing the ring 3082 from pivoting, lying flat, and / or losing its seal. Anatomically, this design and orientation of the seal 3022 can advantageously provide an optimal orientation for effecting a seal with the tissue 3031 of the vaginal or cervical wall.

[0106] refer to Figure 30C , the skirt 3081 of the insertable device 3005 can be configured to flip when the shaft 3033 is pulled proximally. That is, when a force is applied proximally, the flexible skirt 3081 can begin to roll back on itself, generally starting from the portion of the skirt closest to the shaft 3033. The tendency to flip (the force required) can be, for example, determined by the thickness of the skirt 3081, particularly the thickness immediately adjacent to the shaft 3033. In addition, the tendency to flip can be determined by the angle α between the skirt 3081 and the shaft 3033. The larger the angle α, the easier it is to flip. Conversely, the smaller the angle α, the higher the resistance provided by the skirt 3081 to lying flat or pivoting of the plane of the ring 3082.

[0107] like Figure 30DAs shown, the inversion of the skirt 3081 can form a tapered front edge 3091 that separates the tissue 3031 of the vaginal or cervical wall when the edge 3091 is pulled proximally. In addition, 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 have been placed in the vaginal or cervical canal. For example, when the skirt 3081 is inverted, the connection of the skirt 3081 to the rigid ring 3082 can be located at the outermost diameter of the device 3005 so that as the device 3005 is withdrawn proximally, the skirt 3081 (at the shallowest angle to the tissue 3031 of the vaginal or cervical wall) will easily pass over the tissue, especially any repair sutures 3098 that may be located in the vaginal or cervical wall. As the skirt becomes longer (with a smaller angle α and the same diameter rigid ring 3082), the slope against the tissue wall will become shallower, allowing the suture 3098 to be passed more easily.

[0108] It should be understood that while a perpendicular relationship between the plane of the retaining ring 3082 and the longitudinal axis of the shaft 3033 may be advantageous, some variation in this perpendicular relationship may also be helpful in allowing latitude for different anatomies.

[0109] In some embodiments, the thickness of the skirt 3081 can vary from the proximal end to the distal end to optimize the bending mode of the skirt 3081. For example, the thickness can be tailored at a specific distance between the connection of the shaft and the rigid ring. Figure 31 An exemplary insertable device 3105 is shown having thinned portions 3187a, 3187b along the length of skirt 3181. The variation in thickness can facilitate placement and handling / sealing of the device and enhance inversion mechanics during device removal.

[0110] Figure 19 19 is a side view of a cup-shaped cuff seal 1922, with the shaft 1933 of the insertable device extending upward in the middle of the seal 1922. The distal ring 1991 can face the uterus, surround the outside of the cervical opening, and be located in the vaginal vault. The curved proximal end 1993 can cup the cervical opening and create a seal to maintain a vacuum in the uterus.

[0111] Figure 20 is a top view of collapsible seal 2022 in a partially collapsed state. Seal 2022 is similar to seal 1822, except that seal 2022 includes radial pleats 2020 that allow the umbrella to be easily collapsed for insertion (i.e., to fit into a smaller diameter vagina or cervical canal) while allowing the umbrella to expand after insertion to fill a larger space in order to establish a seal to maintain a vacuum within the uterus.

[0112] Figure 21 This is an isometric view of a seal 2122 surrounding the shaft 2133 of an insertable device. Seal 2122 is a flat, disc-shaped seal with multiple connecting rings 2114 that allow the disc to telescope into a conical shape. During use, the outermost ring 2114 captures vaginal or cervical tissue in a larger diameter space during insertion, yet allows the device's shaft 2133 to continue insertion into the uterus if necessary.

[0113] Figure 22 2 is an isometric view of a converging cone seal 2222 having a layered ridge 2221 or rim extending around the circumference. The distal ring 2223 can be designed to be oriented toward the uterus. The converging cone design allows for sealing around the distal ring 2223 during device insertion, yet still allows for further (distal) insertion of the device if desired without dislodging the seal 2222.

[0114] Figures 23A-23B The inverted cup seal 2322 is shown. The distal ring 2331 is used to face the uterus and seal the upper vaginal cavity and around the cervical opening (e.g., the ring 2331 rests in the vaginal vault). The curved distal end 2333 can maintain a vacuum in the uterus. Figure 23B As shown in , the seal 2322 may include multiple spiral ridges and / or valleys, which may, for example, allow for an easier and more predictable method of retracting the seal 2322. These ridges and valleys may allow the physician to gently remove the device without tearing fresh vaginal sutures. Additionally, these ridges and valleys may facilitate insertion of the device, as the seal 2322 may be twisted and grasped between two fingers, thereby allowing for greater visibility during placement.

[0115] Figure 24 An inverted cup seal 2422 is shown that is similar to seal 2322, but seal 2422 includes axially extending corrugations 2441 to facilitate contraction of seal 2422 for insertion. The material used for seal 2422 can be resilient, allowing the material to naturally expand back into the cup shape after the contracting force is removed (e.g., after insertion).

[0116] Figure 25 A cup-shaped seal 2522 is shown that is similar to seal 2322, except that a distal edge 2551 of seal 2522 is slightly flared.

[0117] Figures 26A-26B A seal 2622 is shown that is similar to seal 2622, but includes a compliant, flared distal end 2661 that can be rolled back (ie, proximally) onto itself (eg, to accommodate a smaller diameter vaginal or cervical canal). Figure 26AThe expanded end 2661 is shown, and Figure 26B The proximally rolled end 2661 is shown.

[0118] Figure 27 Shown is a seal 2722 comprising a central disk 2771 or diaphragm supporting a curved annular structure 2773. The annular structure 2773 can seal against the vaginal or cervical walls (e.g., at the cervical opening) to maintain a vacuum within the uterus.

[0119] Figure 28 Shown is a seal 2822 comprising a curved annular structure 2883 supported at a proximal end by attachment to a shaft 2833 and open at a distal end.

[0120] Figure 29 Another exemplary seal 2922 is shown. Seal 2922 includes an expandable bulb 2937 that seals to a shaft 2977 of an insertable device. Bulb 2937 can be made of a material that allows it to anchor in the tissue of the postpartum cervical opening. In some embodiments, for example, bulb 2937 can be made of medium-hard silicone or other flexible materials. Bulb 2937 can also include a tapered portion 2939 at the distal end to facilitate insertion through the vaginal canal and into the cervix. The overall shape of bulb 2937 can advantageously provide a seal when a vacuum is drawn within the uterus. In some embodiments, bulb 2937 can include an annular reinforcement ring 2938 surrounding it. This reinforcement ring can have greater strength than the rest of bulb 2937 to help maintain its round or oval shape when pressed against tissue walls. In some embodiments, reinforcement ring 2938 can be made of the same material as the rest of bulb 2937, but can have an increased thickness.

[0121] In some embodiments, the bulb 2937 can be configured to inflate and deflate only with air from the balancing chamber 2940. The balancing chamber 2940 can be a thin sleeve or balloon made of a very thin and flexible durometer material. The balancing chamber 2940 can be configured to receive air from the bulb 2937 only when the bulb 2937 is compressed. The size or length of the balancing chamber 2940 can be optimized so that compressing the bulb 2937 does not cause the diameter of the balancing chamber 2940 to become larger than the bulb 2937. A channel between the balancing chamber 2940 and the bulb 2937 can allow air to flow back and is formed between the balancing chamber 2940 and the ball 2937 when the bulb 2937 transforms back to its natural shape (e.g., after compression caused during insertion is released). Sealing the bulb 2937 and balancing chamber 2940 can advantageously facilitate cleaning and sterilization if multiple uses are desired.

[0122] In other embodiments, the bulb 2937 can be inflated through an inflation lumen. In other embodiments, the bulb 2937 can be inflated by introducing air through a vent or hole in the proximal end of the bulb 2937 (eg, without a balancing chamber).

[0123] The systems, devices, and methods described herein can advantageously draw a vacuum within the uterus postpartum to remove blood from the uterus and help contract the uterus, thereby stopping postpartum bleeding.

[0124] In some embodiments, at least a portion of the systems and devices described herein can be transparent to allow visualization of blood and fluids aspirated from the uterus.

[0125] A vacuum can be continuously applied to the bleeding uterus for 1-24 hours or less by any of the devices described herein. In some embodiments, the uterus can be maintained in an isobaric state by applying a vacuum. In some embodiments, bleeding can stop in less than 1 hour, such as less than 30 minutes, less than 20 minutes, less than 5 minutes, or less than 2 minutes.

[0126] Any of the devices described herein may be used without a separate sealing member, ie, tissue may be sealed directly around the elongated body or shaft to seal the uterus.

[0127] Any of the devices described herein may include a distal tip having soft, rounded edges to facilitate atraumatic insertion.

[0128] Any of the devices described herein may have a vacuum hole in the distal tip of the device (e.g., aligned with the centerline of the vacuum lumen therethrough and / or aligned with the centerlines of both lumens). Such a vacuum hole can advantageously aid in the entry of blood and clots near the tip and / or facilitate cleaning down the tip of the device (e.g., with a wire brush).

[0129] Any of the devices described herein may be flexible to conform to the local anatomy.

[0130] Any of the devices described herein can be more flexible along a first axis than along a second axis. For example, a device can be more flexible along an axis perpendicular to the coronal plane than along an axis perpendicular to the sagittal plane, which can advantageously help the device conform to the natural upward angle of the uterus. Alternatively, any of the devices described herein can have equivalent flexibility along an axis perpendicular to the coronal plane and along an axis perpendicular to the sagittal plane, for example, to allow placement of the device in the uterus regardless of orientation.

[0131] It should be understood that any one or more elements described herein with respect to one embodiment may be substituted for or added to any one or more elements described herein with respect to another embodiment.

[0132] When a feature or element is referred to as being "on" another feature or element in this article, it can be directly on another feature or element, or there can also be intermediate features and / or elements. On the contrary, when a feature or element is referred to as being "directly on" another feature or element, there are no intermediate features or elements. It will also be understood that when a feature or element is referred to as being "connected," "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to another feature or element or there may be intermediate features or elements. On the contrary, 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 intermediate features or elements. Although described or illustrated with respect to one embodiment, the features and elements described or illustrated in this manner may be applicable to other embodiments. Those skilled in the art will also understand that the structure or feature provided in "adjacent" another feature may have a part that overlaps on or is located below an adjacent feature.

[0133] The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit the present invention. For example, as used herein, the singular forms "a" and "an" are also intended to include the plural forms, unless the context clearly indicates otherwise. It will be further understood that the terms "include" and / or "comprises", when used in this specification, specify the presence of the 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 relevant listed items and can be abbreviated as " / ".

[0134] Spatially relative terms, such as "below", "below", "below", "above", "above", etc., can be used in this article for convenience of description to describe the relationship between one element or feature and another element or the features shown in the figures. It will be understood that, in addition to the orientations depicted in the figures, spatially relative terms are intended to cover different orientations of the device in use or operation. For example, if the device in the figure is inverted, the elements described as "below" or "below" other elements or features will then be oriented as "above" other elements or features. Therefore, the exemplary term "below" can include both upper and lower orientations. The device can be oriented in other ways (rotated 90 degrees or in other directions), and the spatially relative descriptors used herein will be interpreted accordingly. Similarly, unless otherwise specifically stated, the terms "upward", "downward", "vertical", "horizontal", etc. used herein are for illustrative purposes only.

[0135] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), 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, and similarly, a second feature / element may be referred to as a first feature / element without departing from the teachings of the present invention.

[0136] Throughout this specification and the appended claims, unless the context requires otherwise, the word "comprise" and variations such as "comprising" and "comprises" refer to various components that can be used together in methods and articles (e.g., compositions and devices, including devices and methods). For example, the term "comprising" will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0137] As used herein in the specification and claims, including in the embodiments, and unless expressly provided otherwise, all numbers may be understood as if preceded by the word "about" or "substantially", even if the term does not explicitly appear. The phrases "about" or "substantially" may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values ​​and / or positions. For example, a numerical value may be + / - 0.1% of a specified value (or range of values), + / - 1% of a specified value (or range of values), + / - 2% of a specified value, + / - 5% of a specified value (or range of values), + / - 10% of a specified value (or range of values), and so on. Any numerical range described herein is intended to include all subranges contained therein.

[0138] Although various exemplary embodiments have been described above, any of a variety of changes may be made to the various embodiments without departing from the scope of the present invention as described in the claims. For example, the order in which the various described method steps are performed may generally be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be skipped entirely. Optional features of the various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as described in the claims.

[0139] The embodiments and illustrations included herein illustrate, by way of illustration and not limitation, specific embodiments in which the subject matter may be practiced. As described above, other embodiments may be utilized and derived therefrom, thereby allowing structural and logical replacements and changes to be made without departing from the scope of the present disclosure. For convenience only, these embodiments of the subject matter of the present invention may be referred to herein individually or collectively as the term "invention," and if more than one embodiment is actually disclosed, it is not intended that the scope of this application be voluntarily limited to any single invention or inventive concept. Therefore, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may replace the specific embodiments shown. This application is intended to cover any and all modifications or variations of the various embodiments. Upon reading the above description, the combination of the above-described embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art.

Claims

1. A hemostatic device, comprising: an elongated body housing the vacuum passage and configured to be connectable to a vacuum source; a flexible annular portion connected to the elongated body and configured to be contractible for placement in the uterus and self-expandable to an expanded annular shape, the flexible annular portion including a plurality of holes on an inner periphery of the flexible annular portion in fluid communication with the vacuum passage, wherein upon insertion of the elongated body into the uterus, activation of the vacuum source is configured to draw a vacuum through the plurality of holes to contract the uterus; a shield folded around a periphery of the annular portion and having an edge extending radially inwardly relative to the flexible annular distal portion, the shield configured to prevent tissue from obstructing the plurality of holes when a vacuum is applied; and An inflatable seal is coupled to the elongated body and is configured to seal against the uterus.

2. The hemostatic device of claim 1, wherein the shield extends around 270°-320° of the circumference of the flexible annular distal portion.

3. The hemostatic device of claim 1, wherein the shield extends radially inwardly relative to the flexible annular distal portion a distance between 0.02 inches and 0.2 inches.

4. The hemostatic device of claim 1, wherein the plurality of holes comprises 10-20 holes.

5. The hemostatic device of claim 1, wherein the seal has a disc-shaped central portion, a tapered proximal end, and a tapered distal end.

6. The hemostatic device of claim 1, wherein the hemostatic device further comprises a valved port in fluid communication with the elongated body, the valved portion being configured to provide inflation fluid to the inflatable seal.

7. The hemostatic device of claim 6, wherein the valve comprises a check valve.

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