Systems and methods for controlling uterine bleeding

Abstract

To provide an insertable device that is designed to control uterine hemorrhage after childbirth by facilitating contractile movement of the uterus.SOLUTION: An insertable device 105 comprises: a tube 130 having a connecting portion and a suction portion; and a sealing material positioned along the lengthwise direction of the connecting portion, proximal to the suction portion. Upon insertion of the suction portion and the sealing material into the uterus, the sealing material abuts on a vaginal canal and forms a seal between a vaginal opening and the uterus. The suction portion comprises a first loop having an opening that is oriented away from an interior wall of the uterus when the suction portion is inserted into the uterus. The connecting portion of the tube is coupled to a pump 110 that, when actuated, generates negative pressure within the uterus, resulting in a uniform mechanical stimulus to a uterine wall to facilitate tamponade and contractile movement of the tissue.SELECTED DRAWING: Figure 1A

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 378,889, filed Aug. 24, 2016, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] Postpartum hemorrhage, defined as excessive blood loss after delivery, is the leading cause of maternal mortality worldwide, resulting in the deaths of over 125,000 mothers annually. Uncontrolled postpartum hemorrhage can require multiple blood transfusions and, in severe cases, can lead to death unless the uterus is completely removed. It is therefore desirable to control such postpartum hemorrhage at the onset of symptoms, if possible. The cause of postpartum hemorrhage in approximately 80% of cases is uterine atony, which is the inability of the woman's uterus to contract after delivery. Risk factors for uterine atony include prolonged labor, preeclampsia, and having multiple previous births. There is therefore a need for a system that can rapidly induce uterine contractions to reduce or completely stop uterine bleeding. Summary of the Invention [Problem to be solved by the invention]

[0003] The present invention has been made to solve the problems in the conventional techniques described above. [Means for solving the problem]

[0004] An insertable instrument is insertable into the uterus. The insertable instrument includes a tubing connection and a suction portion, and a sealant. The tubing connection is connected to a pump that generates a pressure change when activated. The suction portion of the tube is inserted into the uterus, the suction portion including a first loop, the first loop including an opening defined along a midline surface of the first loop. The opening is oriented away from the inner wall of the uterus when the suction portion is inserted into the uterus. The sealant is disposed along the length of the connection portion and proximal to the suction portion. The sealant abuts the vaginal canal upon insertion of the insertable instrument to form a seal between the vaginal canal and the uterus.

[0005] The figures depict various embodiments of the present invention for illustrative purposes only. As those skilled in the art will readily appreciate from the following description, alternative embodiments of the structures and methods illustrated herein may be used without departing from the principles of the present invention as described herein. [Brief description of the drawings]

[0006] [Figure 1A] ~ [Figure 1C] FIG. 1 illustrates a system for controlling uterine bleeding, according to one embodiment. [Diagram 2] FIG. 1 illustrates an insertable instrument according to one embodiment. [Diagram 3] FIG. 3 illustrates a tube of the insertable instrument of FIG. 2, according to one embodiment. [Figure 4A] ~ [Figure 4B] 4 is a cross-sectional view of an extrusion forming the tube of FIG. 3 according to one embodiment. [Figure 5A] ~ [Figure 5B] 4 is a cross-sectional view of another embodiment of an extrusion forming the tube of FIG. 3. FIG. [Figure 6A] ~ [Figure 6B] 6 illustrates a method of attaching a bridge to the tube of FIG. 5 according to one embodiment. [Figure 7A] ~ [Figure 7E]FIG. 13 illustrates another embodiment of an insertable instrument. [Figure 8] 4 is a cross-sectional view of another embodiment of an extrusion forming the tube of FIG. 3. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0007] FIG. 1A illustrates a system 100 for inhibiting uterine bleeding, according to one embodiment. The system 100 functions to reduce or completely stop uterine bleeding that may occur if a woman develops uterine atony after delivery, in which the uterus does not contract. By inhibiting uterine bleeding, the total amount of blood loss from the uterus is substantially reduced, which may reduce 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 in the uterus and varying the pressure inside the uterus. The change in pressure creates a vacuum inside the uterus, which provides a uniform mechanical stimulation to the uterine wall, promoting tamponade and contractile movement of the tissue. In the embodiment of FIG. 1A, the system 100 includes an insertable instrument 105, a pump 110, and a collection container 115.

[0008] The insertable instrument 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 instrument 105 is delivered transvaginally (through the vagina), with a distal portion 120 of the insertable instrument 105 positioned inside the uterus and a proximal portion 125 of the insertable instrument 105 remaining outside the uterus. The distal portion 120 may be of a flexible structure, allowing the distal portion 120 to conform to the anatomy of the uterus and form a seal at the opening of the uterus. The proximal portion 125 of the insertable instrument 105 is coupled to the pump 110. The distal portion 120 and the proximal portion 125 may have one or more channels and / or openings that allow for fluid communication (e.g., air, biological material, etc.) between the uterus, the pump 110, and the collection container 115. The one or more channels and / or openings transfer the vacuum between the uterus and the pump 110. 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 coupling of airflow from the pump 110 to the uterus. The insertable device 105 is described in more detail with respect to FIG.

[0009] The pump 110 creates a pressure change that creates a vacuum inside the uterus. In the embodiment of Figure 1A, the pump 110 is coupled to the proximal portion 125 of the insertable instrument 105. In some embodiments, a connecting tube 130 has a first end attached to the proximal portion 125 and a second end attached to the pump 110, thereby coupling the pump 110 and the insertable instrument 105. In some embodiments, the connecting tube 130 includes a directional control valve 135, which allows fluid to flow in one direction and prevents fluid from flowing in the reverse direction.

[0010] When activated, the pump 110 generates an air flow that is transmitted through the channels and / or openings of the insertable instrument 105 to the uterus. Generally, a vacuum pump is configured to remove molecules from a sealed space leaving behind a partial vacuum. Because the uterus is sealed by the distal portion 120 of the insertable instrument 105, the air flow by the pump 110 reduces the pressure inside the uterus, which makes the pressure inside the uterus lower than the atmospheric pressure outside the uterus, resulting in a negative pressure. This negative pressure ensures that the air flow moves in a single direction from the uterus through the insertable instrument 105 to the pump 110. The negative pressure creates a vacuum inside the uterus, which provides a uniform mechanical stimulation to the uterine wall, promoting tamponade of the uterine wall, arterial vasoconstriction, and contractile movement. Additionally, the vacuum allows for the removal of biological material inside the uterus. The biological material may include blood, tissue, etc. The pump 110 may be electrically operated and automatically, or may be manually operated. In embodiments in which the pump 110 is manually operated, in a first state, the pump 110 can create a negative pressure within the uterus, and in a second state, the pump 110 can maintain the negative pressure within the uterus while drawing biological material into the collection container 115. Although reference is made throughout to "negative pressure," in some embodiments, a positive pressure may be created within the uterus to promote uterine contractions.

[0011] The collection reservoir 115 collects biological material removed from the uterus. In the embodiment of FIG. 1A, the collection reservoir 115 is coupled to the proximal portion 125 of the insertable instrument 105. The collection reservoir 115 may be coupled via a connecting tube 140 integrated into the proximal portion 125. When the pump 110 is actuated, biological material moves from the uterus and enters the openings and / or channels of the insertable instrument 105, through the connecting tube 140, and into the collection reservoir 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 if, when, and / or to what extent uterine contractions have occurred. In some embodiments, the collection reservoir 115 may be configured as an in-line filter placed before the connecting tube 130 to the pump 110, allowing biological material from the uterus to be filtered out before passing through the insertable instrument 105 and then to the pump 110.

[0012] In some embodiments, the system 100 can be used to prevent postpartum hemorrhage as well as monitor and / or treat it. For example, the system 100 can be used to assist a woman in contracting her uterus after delivery. The flexibility of the insertable instrument 105 allows a healthcare provider (e.g., a nurse, physician, surgeon, etc.) to abdominally palpate the woman's uterine tissue to detect if and / or when the uterus has contracted. Additionally, the flexibility of the insertable instrument 105 allows it to be bent and positioned while other vaginal wall or tissue repair surgeries are being performed.

[0013] In some embodiments, the insertable device 105 may be configured to be inserted into the vaginal canal or cervical canal and remain outside the uterus. As in the manner described above, the distal portion 120 forms a seal between the vaginal or cervical opening and the uterus. By forming a seal, airflow from the pump 110 can reduce the pressure inside the uterus to below atmospheric pressure outside the uterus, creating a vacuum inside the uterus. As previously described, this provides a uniform mechanical stimulation to the uterine wall, promoting tamponade of the uterine wall, arterial vasoconstriction, and contractile movement. This configuration of the insertable device 105 provides a minimally invasive method of suppressing uterine bleeding.

[0014] FIG. 1B illustrates a system 100 for suppressing uterine bleeding according to another embodiment. In the embodiment of FIG. 1B, the system 100 includes an insertable device 105, a pump 110, and a collection container 115. As shown in FIG. 1B, the collection container 115 is connected in series to the pump 110. A 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 actuated, 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.

[0015] FIG. 1C illustrates a system 100 for suppressing uterine bleeding according to another embodiment. In the embodiment of FIG. 1C, the system 100 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, a collection container 115 is integrated with the pump 110, and fluid (e.g., air, biological material, etc.) passes through the connecting tube 130 and into the pump 110, where the biological material is collected in a separate compartment of the pump 110. This compartment that collects the biological material may be removable from the pump 110. This may help the healthcare provider monitor the amount of biological material collected.

[0016] FIG 2 illustrates an insertable instrument 105 according to one embodiment. As described with respect to FIG 1A, the insertable instrument 105 is configured to be inserted into the uterus and transmit pressure changes provided by the pump 110. The distal portion 120 is inserted into the uterus and seals the opening of the uterus, and the proximal portion is coupled to the pump 110. In the embodiment of FIG 2, the insertable instrument 105 includes a tube connector 205, a tube 210, a bridge 215, and a sealant 220. The tube 210 includes a coupling portion 225 and a suction portion 230. Each component of the insertable instrument 105 may be of various designs and may be interchangeable to form alternative configurations of the insertable instrument 105.

[0017] The tube connector 205 connects the insertable instrument 105 to the pump 110. In some embodiments, the tube connector 205 connects to the pump 110 via a connecting tube (e.g., connecting tube 130). In the embodiment of FIG. 2, the tube connector 205 is tapered so that the tube connector 205 may be inserted into the connecting tube and secured to the connecting tube by an interference fit (e.g., pressure fit or friction fit) to the connecting tube. In the embodiment of FIG. 2, the tube connector 205 is attached to the proximal end of the connection portion 225 of the tube 210. The tube connector 205 may be attached to the connection portion 225 by an interference fit (e.g., pressure fit or friction fit), adhesive, threaded joint, or any other suitable fastening mechanism. The tube connector 205 may be constructed of a rigid or semi-rigid plastic (e.g., polyethylene, polypropylene) or any other suitable material.

[0018] The tube 210 acts as a conduit for air and biological material. The tube 210 may include one or more channels that connect the air flow from the pump 110 to the uterus to communicate pressure changes inside the uterus. In the embodiment of FIG. 2, the tube 210 includes a single channel, which has multiple surface features on its inner surface. Alternative embodiments of the tube 210 are described in more detail below with respect to FIGS. 7B-7E. These inner surface features protrude from the inner surface of the channel and can facilitate the flow of air and biological material through the tube 210. These inner surface features may have various configurations, which are described in more detail below with respect to FIGS. 4-5. In the embodiment of FIG. 2, the tube 210 includes a connection portion 225 and a suction portion 230.

[0019] The coupling 225 transfers airflow from the pump 110 to the suction portion 230 of the tube 210. The tube connector 205 is attached to the proximal end of the coupling 225 and removably secures the coupling 225 to the pump 110. The channel in the tube 210 runs the length of the coupling 225. At the distal end of the coupling 225, the tube 210 branches out to form the suction portion 230.

[0020] In the embodiment of FIG. 2, the connection portion 225 and the suction portion 230 are integrally molded (i.e., have a unitary construction) from the same piece of material. To form the suction portion 230 of the tube 210, at least a portion of the single piece of material of the tube 210 is physically split in half, thereby forming two branches 235a, 235b of the suction portion 230 and exposing the midline side of each branch 235 of the channel of the tube 210. Exposing the channels of the tube 210 allows air flow between the pump 110 and the uterus to be connected and allows the tube 210 to transmit pressure changes provided by the pump 110 to the uterus. Furthermore, the exposed channels are advantageously located along the midline side of each branch 235 of the suction portion 230 such that when the insertable instrument 105 is inserted, the exposed channels are oriented away from the inner wall of the uterus. This configuration ensures that uterine tissue or other tissue does not block the exposed channels and impede air flow when the pump 110 is activated. In some embodiments, the orientation of the exposed channels on the suction portion 230 may vary. For example, the exposed channels may be oriented at an off-axis angle from the midline surface of the suction portion 230. In other words, the exposed channels may be oriented at an angle relative to an axis (e.g., a bisection axis) of the midline surface. In some embodiments, the exposed channels may be located on a surface other than the midline surface of the suction portion 230 (e.g., on a lateral surface of the suction portion 230). In these embodiments, the channels may not be exposed after the tube 210 is split to form the two branches 235a, 235b. In other embodiments, the exposed channels on the suction portion 230 may be any combination of these. Furthermore, some exposed channels may not be configured to pass biological material from the uterus. In some embodiments, the connection portion 225 and the suction portion 230 may be separate components / pieces of material that are connected to each other.

[0021] The bridge 215 spans between the branches 235 of the suction portion 230. Each end of the bridge 215 is attached to a distal end of the branch 235 of the suction portion 230. The bridge 215 may be attached by an interference fit (e.g., a friction fit or a pressure fit), adhesive, a threaded joint, or any combination thereof. In the embodiment of FIG. 2, the length of the bridge 215 is sufficient to maintain the separation between the branches 235 of the suction portion 230. In some embodiments, i.e., the manner in which the branches 235 are made (e.g., as described below with respect to FIG. 3), the branches 235 have a natural tendency to come together in a resting state (i.e., when no external force is applied to the branches 235). However, this tendency may cause the exposed channels on each branch 235 to become blocked in a resting state. Thus, the bridge 215 exerts a force on each branch 235 to separate the branches 235 and keep them apart. This configuration prevents the branches 235 of the suction portion 230 from collapsing together when the pump 110 is activated, thus preventing airflow between the pump 110 and the uterus. Additionally, the bridge 215 maintains the alignment of the branches 235 of the suction portion 230 such that the exposed channels along the midline side of the suction portion 230 remain facing inward and facing each other. In one embodiment, the bridge 215 formed to achieve this has a substantially curved body with rounded edges that is directionally constrained to comfortably position the insertable instrument 105 within the uterus when inserted therein and to prevent damage to the uterine wall, while at the same time maintaining its orientation when inserted therein such that the exposed channels remain facing inward. In some embodiments, the shape of the bridge 215 may vary in terms of length, width, curvature, thickness, etc. As a result, distal portion 120 may vary in configuration for placement within the uterus, forming, for example, a circular, oval, triangular, or angular loop, or any other suitable geometric shape. Alternative embodiments of bridge 215 are described below with respect to FIG. 7E. In some embodiments, insertable instrument 105 may not include bridge 215.

[0022] The sealant 220 forms a seal at the uterine opening. In the embodiment of FIG. 2, the sealant 220 is a disk located at the distal end of the connection portion 225 adjacent the suction portion 230, but in alternative embodiments, the sealant 220 may be located at various locations on the connection portion 225 depending on the size / length of the other elements. The disk may be circular, oval, or any other suitable geometric shape for sealing the uterine opening. The disk may or may not include a lip around its periphery that may aid in positioning the sealant against the uterine wall. Additionally, the disk may be convex or concave in profile. The sealant 220 may be composed of a semi-flexible plastic, such as silicone, polyethylene, polypropylene, or any other suitable medical grade material. The flexible material of the sealant 220 allows the sealant 220 to conform to the uterine anatomy, thereby allowing the sealant 220 to be positioned against the uterine opening to form a seal between the uterus and the environment outside the uterus. Sealing the uterus allows the insertable instrument 105 to promote uterine contractions by creating a vacuum to maintain negative pressure inside the uterus. In some embodiments, the sealant 220 may be configured to form a seal anywhere from the vulva to the cervix, vaginal canal, or inside the uterus. Alternative embodiments of the sealant 220 are multiple disks, cups, balloons, sleeves, etc., which may be interchangeable with other components of the insertable instrument 105 (e.g., as described with respect to any of the exemplary embodiments described herein). Each of these alternative embodiments is described in more detail below with respect to FIGS. 7A-7E.

[0023] In some embodiments, the insertable device 105 may include a sheath (not shown) that facilitates insertion of the insertable device 105 into the uterus and may also prevent premature coupling of airflow from the pump 110 to the uterus. The sheath may cover a portion of the tube 210, the bridge 215, and / or the sealant 220, or any combination thereof. As an example, the sheath may be in the form of a translatable outer tube surrounding a portion of the tube 210, or a removable membrane surrounding a distal portion of the insertable device 105, or other similarly configured structure. The sheath may be removed once the suction portion 230 is positioned within the uterus. Removal of the sheath may simultaneously release or place the sealant 220 within the uterus to form a seal. Once use of the system 100 is complete, the sheath may be reattached to the insertable device 105. This reattachment process may simultaneously unseal the sealant 200 and interrupt the airflow connection between the pump 110 and the uterus.

[0024] FIG. 3 illustrates the tube 210 of the insertable device of FIG. 2, according to one embodiment. In the embodiment of FIGS. 2-3, the tube 210 is manufactured by an extrusion process, although in other embodiments, the tube 210 may be manufactured by other methods. In an extrusion process, a material is forced through an extrusion die of the desired cross-sectional profile to form an object having a desired cross-sectional profile. Materials that can be used to extrude the tube 210 may include, for example, silicone, polyethylene, polypropylene, or any other suitable medical grade material. Once formed, the extrusion may be cut to the desired length. In the embodiment of FIG. 3, the tube 210 is an extrusion of a semi-flexible material, which allows the insertable device to conform to the uterine anatomy when inserted into the uterus.

[0025] In the embodiment of Figures 2-3, the extrusion is post-processed to form the final product, tube 210. As described with respect to Figure 2, tube 210 includes connection section 225 and suction section 230. To form suction section 230 of tube 210, a portion of the extrusion is at least partially split in half lengthwise. As shown in Figure 3, the extrusion is cut a distance d along the length of the extrusion from the distal end of tube 210. Distance d is a length suitable to allow suction section 230 to be comfortably inserted into the uterus. In some embodiments, the extrusion die may be designed such that the extrusion includes a groove on its inner or outer surface that extends a particular length along the extrusion. The groove can facilitate the cutting process by indicating the location of the cut and acting as a guide for the tool making the cut. In some embodiments, the groove indicates where the wall thickness of the extrusion is thinner than other portions of the extrusion. A thinner wall thickness may facilitate the cutting process and may allow the extrusion halves to be separated manually to form the suction section 230 .

[0026] In some embodiments, the tube 210 is manufactured by a GeoTrans® extrusion process. In this process, the extrusion die may be designed such that the desired cross-section of the extrusion changes along the length of the extrusion. In particular, the desired cross-section of the connection portion 225 may differ from the desired cross-section of the suction portion 230. For example, the cross-section of the connection portion 225 may be approximately cylindrical or elliptical, whereas the cross-section of the suction portion 230 may include one or more channels. In some embodiments, the cross-section of the extrusion may change along its length in an alternating pattern. The change in cross-section between the connection portion 225 and the suction portion 230 may be designed to be transitional or abrupt.

[0027] Additionally, the extrusion mold may be designed such that the cross section of the tube 210 includes a number of surface features on the inner surface of the tube 210. An example of a surface feature is shown in FIG. 3, where each branch 235 of the suction section 230 includes a central protrusion extending the length of the inner surface of the tube 210. This surface feature may promote the flow of air and biological material within the tube 210, as will be described in more detail below with respect to FIGS. 4-5. By manufacturing the tube 210 in an extrusion process, the post-processing required to form the final insertable device 105 product is minimized. Additionally, once the extrusion mold for a desired extrusion profile is manufactured, large quantities of the extrusion profiles can be produced at high speed (e.g., thousands per day), especially if the extrusion mold is configured to mold multiple extrusion profiles simultaneously. This production can significantly reduce the overall cost of manufacture by reducing the number of parts in the finished device, and can significantly reduce the overall complexity of the device. Furthermore, the design of the insertable instrument 105, specifically the split state of the branches 235 and the bridges 215 that keep the branches 235 separated, allows for great flexibility in the design of surface features on the channel, as the branches 235 do not have to bend or curve very much.

[0028] FIG. 4A illustrates a cross-sectional view of an extrusion 400 for forming a tube 210, according to one embodiment. Specifically, the cross-section of the suction section 230 of the tube 210 is shown before the two halves 405a, 405b of the extrusion 400 are separated to form separate branches of the suction section 230. In the embodiment of FIG. 4A, the extrusion 400 includes an outer wall 410 and a channel 415. The outer wall 410 forms the outer boundary of the tube 210. The outer wall 410 surrounds the channel 415 through which air and biological material can pass. As shown in FIG. 4A, the outer wall 410 is approximately uniform in thickness. The thickness of the outer wall 410 may be approximately 1 to 2.5 millimeters (mm). The outer wall 410 includes two grooves 420a, 420b located on opposite edges of the outer wall. In the embodiment of FIG. 4A, the grooves 420a, 420b are located on the inner and outer surfaces of the outer wall 410, whereby the thickness of the outer wall 410 is narrowed at the grooves 420a, 420b. As described with respect to FIG. 3, the grooves 420a, 420b facilitate the separation of the halves 405a, 405b to form separate branches of the suction portion 230 of the tube 210. In the embodiment of FIG. 4A, the grooves 420a, 420b extend along the length of the tube 210 at the suction portion 230. In some embodiments, the connector 225 may not include the grooves 420a, 420b, and only the suction portion 230 includes the grooves 420a, 420b. This configuration can prevent the separation of the halves 405a, 405b from extending to the connector 225. For embodiments in which grooves 420a, 420b extend along the length of tube 210 at coupling portion 225, the cross-sectional view shown in FIG. 4A also illustrates a cross-section of coupling portion 225.

[0029] In the embodiment of FIG. 4A, the surface of the channel 415 includes a number of surface features, namely, protrusions 425a, 425b and protrusions 430a, 430b, 430c, 430d. As shown in FIG. 4A, these surface features are arranged such that the cross section of the extrusion 400 is generally symmetrical. This arrangement ensures that when the extrusion 400 is split along the grooves 420a, 420b, each branch of the suction section 230 includes the same surface features. The protrusions 425a, 425b are located in the central portion of the channel 415 and protrude toward each other toward the center of the channel 415. The protrusions 430a, 430b are located on the right side of the grooves 420a, 420b, respectively, and protrude toward each other, while the protrusions 430c, 430d are located on the left side of the grooves 420b, 420a, respectively, and protrude toward each other. This configuration of protrusions 425, 430 divides channel 415 into multiple smaller channels, thereby giving each branch of suction portion 230 certain specific characteristics, which will be described in more detail with respect to Figure 4B.

[0030] FIG. 4B shows a cross-sectional view of branch 435a of suction portion 230, according to one embodiment. Specifically, the cross-section shown is of half 405a after both halves 405a, 405b of extrusion profile 400 have been split to form separate branches of suction portion 230. Half 405a forms branch 435a. Branch 435b is not shown, but is formed by half 405b. As shown in FIG. 4B, protrusions 425a, 430a, 430b split channel 415 into two smaller channels 440a, 440b, each having openings 445a, 445b, respectively. As described with respect to FIG. 2, the openings in suction portion 230 allow fluid communication between the uterus and pump 110. Splitting channel 415 into smaller channels 440a, 440b distributes the airflow from pump 110 and increases the number of paths through which air and biological material can travel. Thus, if one pathway becomes blocked by biological material, the other pathway remains accessible and the system 100 can substantially maintain a negative pressure within the uterus. To further prevent blocking of the channels 445a, 445b, the openings 445a, 445b are located on the midline of each branch 435 such that the outer wall 410 faces the uterine wall and the openings 445a, 445b when the suction portion 230 is inserted into the uterus. This configuration prevents uterine or other tissue from blocking the openings 445a, 445b and impeding air flow when the pump 110 is activated.

[0031] In the embodiment of FIG. 4B, the openings 445a, 445b are configured to allow biological material of a particular size to enter the channels 440a, 440b through the openings 445a, 445b, which can be removed from the uterus and collected in the collection container 115. In the embodiment of FIG. 4B, the size of each opening 445a, 445b is approximately 1-4 millimeters (mm). In some embodiments, the size of each opening 445a, 445b is 2-3.5 millimeters (mm). Openings of this size may be further configured to break up clumps of biological material that have formed clots. By breaking up these clumps, the openings 445a, 445b may prevent airflow from the pump 110 from being blocked and allow the biological material to be collected in the collection container 115.

[0032] FIG. 5A shows a cross-sectional view of another embodiment of an extrusion 500 for forming a tube 210. Specifically, a cross-section of the suction section 230 of the tube 210 is shown before the two halves 505a, 505b of the extrusion 500 are separated to form separate branches of the suction section 230. Similar to the extrusion 400, the extrusion 500 includes an outer wall 510 and a channel 515. The outer wall 510 forms the outer boundary of the tube 210. The outer wall 510 surrounds the channel 515 through which air and biological material can pass. As shown in FIG. 5A, the outer wall 510 is generally uniform in thickness. The thickness of the outer wall 510 may be approximately 1 to 2.5 millimeters (mm). The outer wall 510 includes two grooves 520a, 520b located on opposite edges of the outer wall. Similar to grooves 420a, 420b, grooves 520a, 520b facilitate separation of the two halves 505a, 505b to form separate branches of the suction portion 230 of the tube 210. In the embodiment of FIG. 5A, grooves 520a, 520b are located only on the inner surface of the outer wall 510, however, in some embodiments, grooves 520a, 520b may be located on both the inner and outer surfaces of the outer wall 510.

[0033] In the embodiment of FIG. 5A, the surface of the channel 515 includes a plurality of surface features, i.e., protrusions 525a, 525b. As shown in FIG. 5A, the protrusions 525a, 525b are arranged such that the cross section of the extrusion 500 is generally symmetrical. This arrangement ensures that when the extrusion 500 is divided along the grooves 520a, 520b, each branch of the suction section 230 includes the same surface features. The protrusions 525a, 525b are located in a central portion of the channel 515 and project toward each other toward the center of the channel 515. In the embodiment of FIG. 5A, the distal end of each protrusion 525a, 525b extends in a different direction than the portion of the protrusion that extends from the outer wall. In the illustrated embodiment, this portion extends in a different direction forming a shape similar to an umbrella, with each protrusion 525 including a central support structure with curved arms extending from each side of the support structure. Other shapes may be formed in other embodiments, such as, for example, T-shaped protrusions. This general configuration of protrusions 525a, 525b, without regard to their exact shape, divides channel 515 into multiple smaller channels, thereby giving each branch of suction portion 230 certain characteristics, which will be described in more detail with respect to FIG.

[0034] FIG. 5B shows a cross-sectional view of branch 535a of suction section 230. Specifically, the cross-section shown is of half 505a after both halves 505a, 505b of extrusion 500 have been separated to form separate branches of suction section 230. Half 505a forms branch 535a. Branch 535b is not shown, but is formed by half 505b. As shown in FIG. 5B, channel 515 is divided by projection 525a into two smaller channels 540a, 540b, each with its own opening 545a, 545b. As with the embodiment of FIG. 4, dividing channel 515 into smaller channels 540a, 540b distributes the airflow from pump 110 and increases the number of paths through which air and biological material can travel. In the embodiment of FIG. 5B, openings 545a, 545b are spaced apart from one another due to the configuration of projection 525a. By separating the openings 545a, 545b by a distance, it is possible to reduce the possibility that the openings 545a, 545b will be blocked by biological material (potentially by the same mass of biological material) at the same time. Thus, if one opening is blocked by biological material, at least another opening remains accessible, allowing the system 100 to substantially maintain a negative pressure inside the uterus. To further prevent the channel openings 545a, 545b from being blocked, the openings 545a, 545b are located on the midline side of the respective branches 535 such that the outer wall 510 faces the uterine wall and the openings 545a, 545b when the suction unit 230 is inserted into the uterus. This configuration prevents uterine tissue or other tissue from blocking the openings 545a, 545b and impeding air flow when the pump 110 is activated.

[0035] Similar to the embodiment of FIG. 4B, in the embodiment of FIG. 5B, the openings 545a, 545b are configured to allow biological material of a particular size to enter the channels 540a, 540b through the openings 545a, 545b, which can be removed from the uterus and, in some embodiments, collected in the collection container 115. In the embodiment of FIG. 4B, the size of each opening 545a, 545b is approximately 1-4 millimeters (mm). Openings of this size may further be configured to break up clumps of biological material (e.g., tissue clots or clumps). By breaking up these clumps, the openings 545a, 545b may prevent airflow from the pump 110 from being blocked and allow the biological material to be collected in the collection container 115.

[0036] Figure 6A illustrates a method of attaching bridge 215 to tube 210, according to one embodiment. As shown in Figure 6A, a first end of bridge 215 is attached to a distal end of branch 235a of suction portion 230, and a second end of bridge 215 is attached to a distal end of branch 235b of suction portion 230. This configuration of the suction portion of tube 210 ensures that branches 235 are separated and remain separated during insertion into the uterus.

[0037] In the embodiment of FIG. 6A, each end of the bridge 215 includes a mating protrusion 605a (605b not shown) extending from the end of the bridge 215. To secure the bridge 215 to the suction portion 230, the mating protrusions 605a, 605b are inserted into channels in the branches 235b, 235a, respectively. The mating protrusions 605a, 605b may be inserted by an interference fit (e.g., a friction fit or a pressure fit), adhesive, a threaded joint, or any combination thereof. In the embodiment of FIG. 6A, the mating protrusions 605a, 605b are silicone that are bonded to the branches 235b, 235a, respectively.

[0038] FIG. 6B shows a mating projection 605a that secures a first end of the bridge 215 to the branch 235a, according to one embodiment. The mating projection 605a may include a cavity 610 that complements the surface features located on the channel of the branch 235a. In the embodiment of FIG. 6B, the shape of the cavity 610 is designed to complement the shape of the surface features described with respect to FIG. 5B. In this configuration, the surface features 525a may be inserted into the cavity 610, which can increase the stability and security of the attachment between the bridge 215 and the branch 235a. Furthermore, the cavity 610 increases the surface area of ​​the silicone that bonds the mating projections 605a, 605b to the branches 235b, 235a, respectively. Another embodiment may have a cavity 610 designed to complement the shape of the surface features shown in FIGS. 4A and 4B, or any other channel surface feature configuration.

[0039] In some embodiments, the bridge 215 may be configured to transfer airflow from the tube 210. The bridge 215 may include channels or holes along the midline side of the bridge 215, and the mating protrusions 605a, 605b may include channels that couple the airflow of the suction portion 230 to the bridge 215. This configuration provides additional paths through which the airflow and / or biological material can travel.

[0040] 7A-7E show another embodiment of the insertable device. As described with respect to FIG. 2, the insertable device includes several components, such as a tube connector, a tube with a connection and a suction portion, a bridge, and a seal. Each component may have various designs, which will be described in more detail below. Furthermore, the various designs of these components may be interchangeable and combined in several ways to achieve various configurations of the insertable device.

[0041] FIG. 7A illustrates an insertable device 700 according to one embodiment. In the embodiment of FIG. 7A, the insertable device 700 includes a tube connector 205, a tube 210 having a coupling portion 225 and a suction portion 230, a bridge 215, and a sealant 705. Similar to the sealant embodiment described with respect to FIG. 2, the sealant 705 forms a seal at the opening of the uterus. The sealant 705 is comprised of three disks 710a, 710b, 710c located at the distal end of the coupling portion 225 adjacent the suction portion 230. Each disk 710 may be comprised of a semi-flexible material, such as silicone, polyethylene, polypropylene, or any other suitable medical grade material, allowing each disk 710 to conform to the anatomy of the uterus. Each disk 710 has a tapered diameter, with the largest disk 710c closest to the suction portion 230 and the smallest disk 710a furthest from the suction portion 230. In this configuration, the decreasing diameter of the disks 710 can increase the ability of the sealant 705 to be positioned against the uterine opening such that each disk 710 can abut the uterine wall to form a seal between the uterus and the environment outside the uterus. The sealant includes three disks 710 to increase the quality of the seal formed and provide redundancy in maintaining the seal. Alternative embodiments may include different numbers of disks (e.g., two widely spaced disks or ten closely spaced disks) that may be positioned at different distances from each other.

[0042] FIG. 7B illustrates an insertable device 715 according to one embodiment. In the embodiment of FIG. 7B, the insertable device 700 includes a tube connector 205, a tube 720 having a connection portion 725 and a suction portion 730, and a sealant 735. Similar to the tube embodiment described with respect to FIG. 2, the tube 720 acts as a conduit for air and biological materials. The tube 720 may include one or more channels that connect the air flow from the pump 110 to the uterus to communicate pressure changes inside the uterus. In the embodiment of FIG. 7B, the tube 720 is a flexible tube that is folded to form the connection portion 725 and the suction portion 730. The portions of the tube 720 that form the connection portion 725 may be joined together by adhesive, or one or more overmolded pieces secured around the tube 720, or a heat shrink wrap placed over the tube 720. Meanwhile, the connection portion 730 remains a loop. In this configuration, the structure of the tube 720 ensures that the alignment of the midline openings and / or channels of the loops of the suction portion 730 remain facing away from the uterine wall after insertion into the uterus. Furthermore, this configuration eliminates the need for connecting elements (e.g., bridges 215) between the branches of the tube, which can reduce the manufacturing cost of the tube 720. However, it is necessary to appropriately determine the stiffness of the tube 720 so that the tube 720 can be flexible enough to form the loops of the suction portion 730, while being rigid enough so that the suction portion 730 does not potentially break and block the midline openings and / or channels of the loops. Furthermore, the design of the surface features of the surfaces of the channels of the tube 720 may be limited by the desired curvature of the tube 720.

[0043] 7B embodiment, suction portion 730 includes one or more openings 738 located along the midline side of the loop that are oriented away from the inner wall of the uterus when insertable instrument 105 is inserted into the uterus. This configuration prevents uterine or other tissue from blocking openings 738 and impeding airflow during operation of pump 110. Openings 738 may be circular, oval, polygonal, or any other suitable shape that allows air and biological material to pass through. In some embodiments, openings 738 may be channels that extend along the midline side of the loop.

[0044] The sealant 735 forms a seal at the uterine opening. The sealant 735 is located at the distal end of the coupling portion 225 adjacent the suction portion 730. In the embodiment of FIG. 7B, the sealant 735 resembles a cup such that the bottom of the cup is configured to abut the uterine wall at the uterine opening when the insertable instrument 730 is inserted into the uterus. The sealant 735 may be composed of a semi-flexible material, such as silicone, polyethylene, polypropylene, or any other suitable medical grade material, allowing the sealant 735 to conform to the uterine anatomy.

[0045] Figure 7C illustrates an insertable device 740 according to one embodiment. In the embodiment of Figure 7C, the insertable device 740 includes a tube connector 205, a tube 720 having a coupling portion 725 and a suction portion 730, and a sealant 220. The insertable device 740 combines the tube configuration described with respect to Figure 7B with the seal configuration described with respect to Figure 2.

[0046] FIG. 7D illustrates an insertable device 745 according to one embodiment. The insertable device 745 is one embodiment of the insertable device 740. In the embodiment of FIG. 7D, the insertable device 745 includes a tube connector 205, a tube 720 having a coupling portion 725 and a suction portion 730, a sealant 220, and a shield 750. The shield 750 is a porous mesh that allows particles of a certain size to pass through it. In the embodiment of FIG. 7D, the shield 750 surrounds the suction portion 730 to prevent uterine tissue from blocking the opening 738 and to allow other biological material (e.g., blood) to pass through. The shield 750 may be composed of gauze, nylon, or other suitable material that can be placed inside the uterus.

[0047] 7E illustrates an insertable device 755 according to one embodiment. In the embodiment of FIG. 7E, the insertable device 755 includes a tube connector 205, a tube 760 having a connecting portion 765 and a suction portion 770, and a sealant 775.

[0048] Tube 760 serves as a conduit for air and biological materials. Tube 760 is similar in geometry to tube 720, but tube 760 is made from two separate tubes 780a, 780b rather than one folded tube. Each tube 780a, 780b includes an internal channel that runs the length of the tube. In the embodiment of FIG. 7E, tubes 780a, 780b are positioned adjacent to one another, and portions of tubes 780a, 780b can be joined to form connector 765. These tubes can be joined by adhesive, or by one or more overmolded pieces secured around connector 765, or by heat shrink wrap placed over tube connector 765. The remaining portions of tubes 780a, 780b are bent to mate the end of tube 780a with the end of tube 780b to form a loop that becomes suction section 770. The ends of tubes 780a, 780b may be joined by a plug 785. In the embodiment of FIG. 7E, a first end of plug 785 is inserted into a channel of tube 780a and a second end of plug 785 is inserted into a channel of tube 780b. Plug 785 may be secured to the interior of tubes 780a, 780b with an adhesive. Plug 785 may include openings or channels that form a continuous pathway for airflow and / or biological material through tube 760. In some embodiments, plug 785 may be designed to fit over the ends of tubes 780a, 780b as a cross-tube connector. In embodiments in which the suction portion of the tube includes two separate branches that are connected, the connecting element (e.g., bridge 215 or plug 785) may have a variety of configurations and may be any size, depending on the stiffness of the tube and providing that the connecting element properly mates the branches together so that the openings or channels in each branch remain unobstructed when the insertable instrument is inserted into the uterus, allowing a vacuum to be generated within the uterus.

[0049] In the embodiment of FIG. 7E, suction portion 770 includes one or more openings 790. The openings 790 are created by skiving the outer surface of suction portion 770. The skiving process carves notches into the surface of suction portion 770. The openings 790 are positioned along the midline side of the loop such that the openings 790 are oriented away from the inner wall of the uterus when insertable instrument 105 is inserted into the uterus. This configuration prevents uterine or other tissue from obstructing openings 790 and impeding airflow when pump 110 is activated.

[0050] The sealant 775 forms a seal at the opening of the uterus. In the embodiment of FIG. 7E, the sealant 775 is a sleeve or balloon that can be inflated once the suction portion 770 is positioned inside the uterus. The sealant 775 can be inserted flat, allowing it to be properly positioned before being inflated. The sealant 775 can be positioned inside the vaginal canal, cervix, or uterus. In the embodiment of FIG. 7E, the sealant 775 can include a tube 795 that can lead to a pump 110 that inflates the sealant 775. The sealant 775 can be composed of silicone, polyethylene, polypropylene, or any other suitable medical grade material.

[0051] FIG. 8 illustrates a cross-sectional view of another embodiment of an extrusion profile 800 for making the tube 210. Specifically, the cross-section of the suction section 230 of the tube 210 is shown before the two halves 805a, 805b of the extrusion profile 800 are separated to form separate branches of the suction section 230. In the embodiment of FIG. 8, the extrusion profile 800 includes an outer wall 810, a channel 815, channels 820a, 820b, and rings 825a, 825b. The outer wall 810 forms the outer boundary of the tube 210. The outer wall 810 surrounds the channels 815, 820a, 820b. As shown in FIG. 8, the outer wall 810 is approximately uniform in thickness. The thickness of the outer wall 810 may be approximately 1 to 2.5 millimeters (mm). The outer wall 810 includes two grooves 830a, 830b located on opposite edges of the outer wall 810. In the embodiment of FIG. 8, the grooves 830a, 830b are located on the inner and outer surfaces of the outer wall 810, whereby the thickness of the outer wall 810 is narrowed at the grooves 830a, 830b. As described with respect to FIG. 3, the grooves 830a, 830b facilitate the separation of the halves 805a, 805b to form separate branches of the suction portion 770 of the tube 760. In the embodiment of FIG. 8, once the halves 805a, 805b are separated to form the branches of the suction portion 770, the branches are bent towards each other to form a loop, with a first end of the first branch mating with a first end of the second branch. A pin may be inserted into the rings 825a, 825b to secure the ends of the branches together. The pin may be glued into the rings 825a, 825b.

[0052] Once the halves 805a, 805b are separated, channel 815 is exposed, allowing fluid communication between pump 110 and the uterus. The walls between channel 815 and each channel 820a, 820b may include one or more openings (e.g., holes or channels) to allow biological material to enter channel 815 and flow into channels 820a, 820b. In this configuration, channels 820a, 820b act as drainage channels. This configuration may help channel 815 remain unobstructed.

[0053] The above description of the embodiments of the present invention has been provided for purposes of illustration and is not intended to be exhaustive or to limit the invention to the precise form disclosed. Those skilled in the art will recognize that numerous modifications and variations are possible in light of the above disclosure.

[0054] The language used herein has been selected primarily for ease of reading and instructional purposes, and may not have been selected to define the metes and bounds of the inventive subject matter. Accordingly, the scope of the invention is not to be limited by this detailed description, but rather by any claims issued on an application based thereon. Accordingly, the disclosure of embodiments of the invention is intended to be illustrative, but not limiting, of the scope of the invention. [Appendix 1] 1. An insertable device comprising: a tube connection connected to a vacuum source that generates a pressure change when activated; A suction portion of the tube that can be inserted into a uterus, a first loop including an opening that is oriented away from the inner wall of the uterus when the suction portion is inserted into the uterus; The suction unit includes: a sealant disposed lengthwise of the connecting portion proximal to the suction portion, the sealant abutting the vaginal canal upon insertion of the insertable instrument to form a seal between the vaginal opening and the uterus; An insertable device comprising: [Appendix 2] 2. The insertable device of claim 1, wherein the connection portion and the suction portion are separate components that are connected to each other. [Appendix 3] 2. The insertable device of claim 1, wherein the connecting portion and the suction portion are of integral construction. [Appendix 4] 2. The insertable device of claim 1, wherein the tube is manufactured as an extrusion. [Appendix 5] 5. The insertable device of claim 4, wherein the extrusion has a constant cross-section. [Appendix 6] 6. The insertable instrument of claim 5, wherein the extrusion includes a channel having surface features protruding from a surface of the channel. [Appendix 7] 5. The insertable device of claim 4, wherein the extrusion has a cross-section that varies along the length of the extrusion. [Appendix 8] 5. The insertable instrument of claim 4, wherein the extrusion includes at least one groove extending along the length of the suction portion of the extrusion, the at least one groove being disposed between edges of the extrusion, and post-processing of the extrusion includes cutting the extrusion lengthwise along the at least one groove such that the suction portion of the extrusion is divided into two portions. [Appendix 9] 2. The insertable device of claim 1, wherein the tube includes channels through which air and biological materials travel. [Appendix 10] 10. The insertable instrument of claim 9, wherein a surface of the channel includes surface features protruding from the surface of the channel, the surface features dividing the channel into a plurality of smaller channels. [Appendix 11] 11. The insertable instrument of claim 10, wherein the first loop includes a plurality of openings, each opening leading to at least one of the plurality of smaller channels. [Appendix 12] 12. The insertable device of claim 11, wherein the width or length of each of the plurality of openings is within the range of 2 to 3.5 millimeters (mm). [Appendix 13] 2. The insertable instrument of claim 1, wherein the opening of the suction portion includes one or more channels extending along a portion of the midline surface of the first loop. [Appendix 14] 2. The insertable instrument of claim 1, wherein the opening of the suction portion includes a plurality of openings along a midline surface of the first loop. [Appendix 15] 2. The insertable device of claim 1, wherein the first loop of the suction portion includes a first branch and a second branch of the tube connected by a bridge, the bridge being attached to a distal end of each branch. [Appendix 16] 16. The insertable device of claim 15, wherein the bridge separates the distal ends of the first branch and the second branch by a distance, and a length of the bridge prevents the first branch and the second branch from folding over one another. [Appendix 17] 16. The insertable instrument of claim 15, wherein a first end of the bridge is inserted into a channel of the first branch and a second end of the bridge is inserted into a channel of the second branch. [Appendix 18] 16. The insertable device of claim 15, wherein a distal end of the first branch includes a first ring and a distal end of the second branch includes a second ring, each ring protruding from an outer surface of the respective branch, each ring including a hole, the first ring and the second ring are oriented such that the holes are aligned with each other, the bridge is generally pin-shaped, a first end of the bridge is inserted into the hole of the first ring and the second end of the bridge is inserted into the hole of the second ring, thereby connecting the first branch and the second branch. [Appendix 19] 2. The insertable device of claim 1, wherein the sealing material comprises a single disk. [Appendix 20] 2. The insertable device of claim 1, wherein the sealing material comprises a plurality of discs. [Appendix 21] 2. The insertable device of claim 1, wherein the sealant comprises a balloon that expands once the sealant is positioned inside the uterus or vaginal canal. [Appendix 22] 2. The insertable instrument of claim 1, wherein the sealant comprises a cup-like geometric shape and the sealant is oriented such that a bottom surface of the sealant is oriented away from the suction portion or toward the suction portion. [Appendix 23] 2. The insertable instrument of claim 1, further comprising a shield surrounding the suction portion, the shield configured to prevent the opening in the first loop from being obstructed by biological material. [Appendix 24] 2. The insertable device of claim 1, further comprising a sheath that covers at least the suction portion and facilitates insertion of the suction portion into the uterus. [Appendix 25] 25. The insertable instrument of claim 24, wherein the sheath may be removed after the suction portion is at a desired location within the uterus, thereby exposing the opening in the suction portion. [Appendix 26] 2. The insertable device of claim 1, wherein the tube is constructed of a flexible material. [Appendix 27] 2. The insertable device of claim 1, wherein the coupling portion is coupled to a container that collects biological material from the uterus, the container configured to indicate the amount of biological material collected. [Appendix 28] 2. The insertable instrument of claim 1, wherein the opening of the suction portion is defined along a midline surface of the first loop.

Claims

1. 1. An insertable device comprising: a suction portion configured in a single loop, fluidly connected to a distal end of a connector portion and insertable into a uterus, the suction portion having a channel having an inner surface extending along two branches of the loop, and a central protrusion extending from the inner surface of the channel to a center of the channel and extending along the length of the channel; a sealant located between the suction portion and the connecting portion and forming a seal between the vaginal opening and the uterus; 1. An insertable device comprising:

2. The insertable instrument of claim 1 , wherein the coupling portion and the suction portion are separate components that are coupled to one another.

3. The insertable instrument of claim 1 , wherein the coupling portion and the suction portion are of unitary construction.

4. The insertable instrument of claim 1 , wherein the inner surface is recessed.

5. The insertable instrument of claim 1 , wherein the proximal end of the coupling portion is configured to be coupled to a vacuum source.

6. The insertable device of claim 5 , wherein the suction portion and the sealant are configured to maintain a negative pressure within the uterus.

7. The insertable instrument of claim 1 , wherein the sealant is configured as a disc, a cup, a balloon, or a sleeve.

8. The insertable instrument of claim 1 , wherein the suction portion has a bridge connected between the two branches.

9. The insertable instrument of claim 1 , wherein the channel has a curved outer surface.

10. The insertable instrument of claim 1 , wherein the insertable instrument is flexible.

11. The insertable instrument of claim 1 , wherein the central projection defines two openings spaced apart along the length of the channel.

12. The insertable instrument of claim 1 , wherein the distal end of the central projection has an extending portion.

13. The insertable instrument of claim 12 , wherein the extending portion has an umbrella-like, T-like, or curved shape.

14. The insertable instrument of claim 1 , wherein the inner surface of the channel is exposed on a midline side of the loop.

15. The insertable instrument of claim 1 , wherein the central protrusion divides the channel into two smaller channels.

16. The insertable instrument of claim 1 , wherein the channel includes additional protrusions extending toward the center near each edge of the channel.

17. The insertable instrument of claim 16 , wherein the additional protrusions prevent debris from entering the channel.

18. The insertable instrument of claim 1 , further comprising a shield surrounding the suction portion.

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