Patent Description:
<CIT> discloses a drainage system and electronic vacuum pump which can be used for intrauterine therapy. An open-pored fluid collection body with a tube-shaped fluid communication element is connected fluid-conductively to an electric vacuum pump via a secretion collection tank. After placement in the uterus, a vacuum is applied to the drainage system with a contraction pattern similar to labour contractions or postpartum contractions.

<CIT> discloses a uterine hemorrhage controlling system comprising a suction module including a suction end coupleable to a pump by a connecting tube, and a sealing module coupled to the suction module.

<CIT> discloses catheters useful in extracting fluids from the peritoneal cavity of humans.

There is hereinafter disclosed an insertable device insertable into a uterus.

Aspects, embodiments and examples of the present disclosure which do not fall under the scope of the appended claims do not form part of the invention and are merely provided for illustrative purposes.

<FIG> illustrates a system <NUM> for controlling uterine hemorrhaging, according to an embodiment. The system <NUM> functions to reduce or entirely stop uterine hemorrhaging, which may occur after childbirth when a woman experiences uterine atony, wherein the uterus fails to contract. Controlling uterine hemorrhaging substantially reduces the total blood lost from the uterus and may reduce a woman's need for a blood transfusion or a hysterectomy. In the embodiment of <FIG>, the system <NUM> facilitates contraction of the uterus by sealing an opening to the uterus and providing a pressure change within the uterus. Changing the pressure generates a vacuum within the uterus that results in a uniform mechanical stimulus to the uterine wall in order to facilitate tamponade and contractile movement of the tissue. In the embodiment of <FIG>, the system <NUM> includes an insertable device <NUM>, a pump <NUM>, and a collection container <NUM>.

The insertable device <NUM> is configured to be inserted into the uterus to transmit the pressure change provided by the pump <NUM>. In the embodiment of <FIG>, the insertable device <NUM> is delivered transvaginally (through the vagina) such that a distal portion <NUM> of the insertable device <NUM> is positioned within the uterus while a proximal portion <NUM> of the insertable device <NUM> remains external to the uterus. The distal portion <NUM> may have a flexible structure such that it conforms to the anatomy of the uterus and allows the distal portion <NUM> to create a seal at the opening of the uterus. The proximal portion <NUM> of the insertable device <NUM> couples to the pump <NUM>. The distal and proximal portions <NUM>, <NUM> may have one or more channels and/or openings that allow fluid communication (e.g., of air, biological materials, etc.) between the uterus, the pump <NUM>, and the collection container <NUM>. The one or more channels and/or openings transfer the vacuum between the uterus and the pump <NUM>. In some embodiments, the insertable device <NUM> may have a sheath that facilitates insertion of the insertable device <NUM> into the uterus and may additionally prevent a premature connection of the airflow from the pump <NUM> to the uterus. The insertable device <NUM> will be discussed in further detail with regards to <FIG>.

The pump <NUM> creates a pressure change that generates a vacuum within the uterus. In the embodiment of <FIG>, the pump <NUM> is coupled to the proximal portion <NUM> of the insertable device <NUM>. In some embodiments, a connection tubing <NUM> attaches to the proximal portion <NUM> at a first end and attaches to the pump <NUM> at a second end, thereby coupling the pump <NUM> and the insertable device <NUM>. In some embodiments, the connection tubing <NUM> includes a directional control valve <NUM> that allows fluid to flow in one direction and prevents fluid from flowing in the opposite direction.

When actuated, the pump <NUM> creates an airflow that is transmitted through the channels and/or openings of the insertable device <NUM> to the uterus. In general, vacuum pumps are configured to remove molecules from a sealed volume in order to leave behind a partial vacuum. Since the uterus is sealed by the distal portion <NUM> of the insertable device <NUM>, the airflow by the pump <NUM> decreases the pressure inside the uterus, causing the uterine pressure to drop lower than the atmospheric pressure outside of the uterus and resulting in a negative pressure. The negative pressure ensures that the airflow travels in a single direction from the uterus and through the insertable device <NUM> towards the pump <NUM>. The negative pressure generates a vacuum inside the uterus, which facilitates tamponade, arterial vessel constriction, and contractile movement of the uterine wall by providing a uniform mechanical stimulus. In addition, generating a vacuum allows biological materials within the uterus to be removed. Biological materials may include blood, tissue, etc. The pump <NUM> may be power/automatically operated or manually operated. The embodiments in which the pump <NUM> is manually operated, the pump <NUM> may create a negative pressure within the uterus when in a first state, and in a second state, the pump <NUM> may draw biological materials into the collection container <NUM> while maintain the negative pressure within the uterus. While a "negative pressure" is referred to throughout, some embodiments may generate a positive pressure inside the uterus to facilitate contractions of the uterus.

The collection container <NUM> collects the biological materials removed from the uterus. In the embodiment of <FIG>, the collection container <NUM> is coupled to the proximal portion <NUM> of the insertable device <NUM>. The collection container <NUM> may be coupled via a connection tubing <NUM> that is integrated into the proximal portion <NUM>. When the pump <NUM> is actuated, the biological materials travel from the uterus, into the openings and/or channels of the insertable device <NUM>, and through the connecting tubing <NUM> into the collection container <NUM>. Collecting biological materials from the uterus may allow a user to monitor and measure the amount of blood loss due to uterine hemorrhaging. Monitoring the blood loss additionally allows the user to determine whether, when, and/or to what extent uterine contraction has occurred. In some embodiments, the collection container <NUM> may be configured as an inline filter that is positioned before the connection tubing <NUM> to the pump <NUM>, allowing biological materials from the uterus to flow through the insertable device <NUM> and be filtered out before the pump <NUM>.

In some embodiments, the system <NUM> may be used to prevent postpartum hemorrhage in addition to monitoring and/or treating it. For example, the system <NUM> may be used in any woman after birth to aid uterine contraction. The flexibility of the insertable device <NUM> allows a healthcare provider (e.g., nurse, physician, surgeon, etc.) to palpate a woman's uterine tissue abdominally in order to detect if and/or when the uterus has contracted. In addition, the flexibility of the insertable device <NUM> allows the insertable device <NUM> to be flexed and positioned while other vaginal wall or tissue repair surgical procedures are being conducted.

In some embodiments, the insertable device <NUM> may be configured for insertion into a vaginal canal or a cervical canal such that the insertable device <NUM> remains external to the uterus. In a similar manner as described above, the distal portion <NUM> creates a seal between a vaginal opening or a cervical opening and the uterus. Creating the seal allows the airflow by the pump <NUM> to decrease the pressure inside the uterus, causing the uterine pressure to drop lower than the atmospheric pressure outside of the uterus and generating a vacuum inside the uterus. As previously described, this facilitates tamponade, arterial vessel constriction, and contractile movement of the uterine wall by providing a uniform mechanical stimulus. This configuration of the insertable device <NUM> may provide a less invasive method for controlling uterine hemorrhaging.

<FIG> illustrates a system <NUM> for controlling uterine hemorrhaging, according to an additional embodiment. In the embodiment of <FIG>, the system <NUM> includes an insertable device <NUM>, a pump <NUM>, and a collection container <NUM>. As illustrated in <FIG>, the collection container <NUM> is connected in-line with the pump <NUM>. The proximal portion <NUM> of the insertable device <NUM> couples to the collection container <NUM> and the pump <NUM> via the connection tubing <NUM>. In this embodiment, the fluid (e.g., air, biological materials, etc.) flows through the connection tubing <NUM> towards the pump <NUM> when the pump <NUM> is activated. The biological material is removed from the connection tubing <NUM> prior to reaching the pump <NUM> and collects in the collection container <NUM>.

<FIG> illustrates a system <NUM> for controlling uterine hemorrhaging, according to an additional embodiment. In the embodiment of <FIG>, the system <NUM> includes an insertable device <NUM> and a pump <NUM>. The proximal portion <NUM> of the insertable device <NUM> couples to the pump <NUM> via the connection tubing <NUM>. In this embodiment, the collection container <NUM> is integrated with the pump <NUM> such that the fluid (e.g., air, biological materials, etc.) flows through the connection tubing <NUM> into the pump <NUM>, in which the biological materials are collected into a separate compartment of the pump <NUM>. The compartment that collects the biological material may be removable from the pump <NUM>. This may assist a healthcare provider in monitoring the amount of biological material collected.

<FIG> illustrates the insertable device <NUM>, according to an embodiment. As described with regards to <FIG>, the insertable device <NUM> is configured to be inserted into the uterus to transmit the pressure change provided by the pump <NUM>. The distal portion <NUM> is inserted into the uterus and seal an opening to the uterus, and the proximal portion couples to the pump <NUM>. In the embodiment of <FIG>, the insertable device <NUM> includes a tube connector <NUM>, a tube <NUM>, a bridge <NUM>, and a seal <NUM>. The tube <NUM> includes a connecting portion <NUM> and a suction portion <NUM>. Each component of the insertable device <NUM> may have a variety of designs and may be interchangeable to create alternate configurations of the insertable device <NUM>.

The tube connector <NUM> couples the insertable device <NUM> to the pump <NUM>. In some embodiments, the tube connector <NUM> couples to the pump <NUM> via connection tubing (e.g., connecting tubing <NUM>). In the embodiment of <FIG>, the tube connector <NUM> is tapered such that it may be inserted into the connection tubing and secured to the connection tubing via an interference it (e.g., press fit or friction fit). In the embodiment of <FIG>, the tube connector <NUM> attaches to a proximal end of the connecting portion <NUM> of the tube <NUM>. The tube connector <NUM> may be attached to the connecting portion <NUM> via an interference fit (e.g., press fit or friction fit), an adhesive, a threaded interface, or any other suitable securing mechanism. The tube connector <NUM> may be composed of rigid or semi-rigid plastic (e.g., polyethylene, polypropylene) or any other suitable material.

The tube <NUM> acts as a conduit for air and biological materials. The tube <NUM> may comprise one or more channels that couple airflow from the pump <NUM> to the uterus to transmit a change in pressure inside the uterus. In the embodiment of <FIG>, the tube <NUM> includes a single channel having surface features on an internal surface of the channel. Alternate embodiments of the tube <NUM> will be discussed in further detail with regards to <FIG>. The internal surface features protrude from the internal surface of the channel and may aid the flow of air and biological materials through the tube <NUM>. The internal surface features may have a variety of configurations, which will be discussed in further detail with regards to <FIG>. In the embodiment of <FIG>, the tube <NUM> includes the connecting portion <NUM> and the suction portion <NUM>.

The connecting portion <NUM> transmits airflow from the pump <NUM> to the suction portion <NUM> of the tube <NUM>. The tube connector <NUM> is attached at a proximal end of the connecting portion <NUM> and removably secures the connecting portion <NUM> to the pump <NUM>. The channel of the tube <NUM> extends down the length of the connecting portion <NUM>. At a distal end of the connecting portion <NUM>, the tube <NUM> branches out to form the suction portion <NUM>.

The connecting portion <NUM> and the suction portion <NUM> are integrally formed of the same piece of material (i.e., have a unitary construction). To create the suction portion <NUM> of the tube <NUM>, the tube's <NUM> single piece of material is at least partially physically split in half, thereby creating two branches 235a, 235b of the suction portion <NUM> and exposing the channel of the tube <NUM> on a medial side of each branch <NUM>. Exposing the channel of the tube <NUM> connects the airflow between the pump <NUM> and the uterus, allowing the tube <NUM> to transmit the change in pressure provided by the pump <NUM> to the uterus. In addition, the exposed channels are beneficially located along a medial side of each branch <NUM> of the suction portion <NUM> such that the exposed channels are oriented away from an interior wall of the uterus when the insertable device <NUM> is inserted. This configuration prevents uterine tissue or other tissue from obstructing the exposed channels and preventing airflow when the pump <NUM> is actuated. In some embodiments, the orientation of the exposed channels on the suction portion <NUM> may vary. For example, the exposed channels may be oriented at an off-axis angle from the medial surface of the suction portion <NUM>. In other words, the exposed channels may be oriented at an angle relative to an axis (e.g., a bisecting axis) of the medial surface. In some embodiments useful for understanding the invention, the exposed channels may be located on a surface other than the medial surface of the suction portion <NUM> (e.g., a lateral surface of the suction portion <NUM>). In these embodiments, that are useful for understanding the invention, channels may not be exposed after the tube <NUM> is split to create the two branches 235a, 235b. In other embodiments, the exposed channels on the suction portion <NUM> may be some combination thereof. In addition, some exposed channels may not be configured to pass biological material from the uterus. In some embodiments useful for understanding the invention, the connecting portion <NUM> and the suction portion <NUM> may be separate components/pieces of material that are coupled to each other.

The bridge <NUM> spans between the branches <NUM> of the suction portion <NUM>. Each end of the bridge <NUM> is attached to a distal end of a branch <NUM> of the suction portion <NUM>. The bridge <NUM> may be attached via an interference fit (e.g., friction fit or press fit), an adhesive, a threaded interface, or some combination thereof. In the embodiment of <FIG>, the length of the bridge <NUM> is sufficient enough to maintain a separation between the branches <NUM> of the suction portion <NUM>. In some implementations, the manner in which the branches <NUM> are constructed, for example as described with respect to <FIG> below, the branches <NUM> have a natural tendency to come together in a resting state (i.e., when no external force is exerted on the branches <NUM>). However, this tendency may cause the exposed channels on each branch <NUM> to become obstructed in the resting state. Thus, the bridge <NUM> exerts a force on each branch <NUM> to separate the branches <NUM> into a split state. This configuration prevents the branches <NUM> of the suction portion <NUM> from collapsing into each other when the pump <NUM> is actuated and thereby obstructing the airflow between the pump <NUM> and the uterus. In addition, the bridge <NUM> maintains the alignment of the branches <NUM> of the suction portion <NUM> such that the exposed channels along the medial side of the suction portion <NUM> remain facing inward towards each other. In one embodiment this is accomplished by forming the bridge <NUM>, which has a substantially curved body with rounded edges, directionally-limiting so that the insertable device <NUM> is positioned comfortably within the uterus when inserted and to prevent damage to the uterine wall, while also maintaining its orientation when inserted so as to keep the exposed channel oriented inward as discussed. In some embodiments, the shape of the bridge <NUM> may vary in terms of the length, width, curvature, thickness, etc. As a result, the configuration of the distal portion <NUM> may vary, for example, to form a circular, elliptical, triangular, or horn-shaped loop, or any other suitable geometries for placement within the uterus.

The seal <NUM> creates a seal at the opening of the uterus. In the embodiment of <FIG>, the seal <NUM> is a disk positioned at a distal end of the connecting portion <NUM>, adjacent to the suction portion <NUM>, however in alternate embodiments it may be placed at varying locations along the connecting portion <NUM> depending on the size/length of the other elements. The disk may be circular, elliptical, or any other suitable geometry for sealing an opening to the uterus. The disk may or may not include a lip around its perimeter, wherein the lip may help position the seal against the uterine wall. In addition, the disk may have a convex or a concave profile. The seal <NUM> may be composed of semi-flexible plastics, such as silicone, polyethylene, polypropylene, or any other suitable medical-grade material. The flexible material of the seal <NUM> allows the seal <NUM> to conform to the anatomy of the uterus such that the seal <NUM> may be positioned against an opening of the uterus to form a seal between the uterus and an environment external to the uterus. Sealing the uterus allows the insertable device <NUM> to create a vacuum and maintain a negative pressure within the uterus to facilitate contraction of the uterus. In some embodiments, the seal <NUM> may be configured to form a seal at any point from the vulva, the cervix, the vaginal canal, or within the uterus. An additional embodiment of the seal <NUM> is a plurality of disks.

In some embodiments, the insertable device <NUM> may include a sheath (not shown) that facilitates insertion of the insertable device <NUM> into the uterus and may additionally prevent a premature connection of the airflow from the pump <NUM> to the uterus. The sheath may cover a portion of the tube <NUM>, the bridge <NUM>, and/or the seal <NUM>, or some combination thereof. As an example, the sheath may be in the form of a translatable outer tube that encloses a portion of the tube <NUM>, a removable membrane that encloses distal portions of the insertable device <NUM>, or other structures having a similar configuration. The sheath may be removed once the suction portion <NUM> is positioned within the uterus. Removal of the sheath may simultaneously release or position the seal <NUM> in the uterus to create the seal. When use of the system <NUM> is complete, the sheath may be re-installed onto the insertable device <NUM>. The re-installation process may simultaneously break the seal from the seal <NUM> and cut off the connection of the airflow between the pump <NUM> and the uterus.

<FIG> illustrates the tube <NUM> of the insertable device of <FIG>, according to an embodiment. In the embodiment of <FIG>, the tube <NUM> is manufactured through an extrusion process, though in other embodiments the tube <NUM> may be manufactured in other ways. An extrusion process is used to create objects having a desired cross-sectional profile by pushing a material through a die of the desired cross-section. Materials such as silicone, polyethylene, polypropylene, or any other suitable medical-grade material may be used for the extrusion process of the tube <NUM>. Once the extrusion is created, the extrusion may be cut to a desired length. In the embodiment of <FIG>, the tube <NUM> is extruded using a semi-flexible material, which allows the insertable device to conform to the anatomy of a uterus when inserted.

In the embodiment of <FIG>, the extrusion undergoes post-processing to form the final product, the tube <NUM>. As described with regards to <FIG>, the tube <NUM> includes the connecting portion <NUM> and the suction portion <NUM>. To create the suction portion <NUM> of the tube <NUM>, a portion of the extrusion is at least partially split in half along its length. As illustrated in <FIG>, the extrusion is cut from a distal end of the tube <NUM> down to the length of the extrusion by a distance d. The distance d is a suitable length that allows the suction portion <NUM> to be inserted comfortably into a uterus. In some embodiments, the die may be designed such that the extrusion includes a groove on an internal or external surface that extends down a certain length of the extrusion. The groove may facilitate the cutting process by indicating the location of the cut and acting as a guide for the tool performing the cut. In some embodiments, the groove indicates a location at which the wall thickness of the extrusion is thinner than the remainder of the extrusion. A thinner wall thickness may ease the cutting process or allow two halves of the extrusion to be separated manually to form the suction portion <NUM>.

In some embodiments, the tube <NUM> is manufactured through a GeoTrans® extrusion process. In this process, the die may be designed such that the desired cross-section of the extrusion changes along the length of the extrusion. Specifically, a desired cross-section for the connecting portion <NUM> may differ from a desired cross-section for the suction portion <NUM>. For example, the cross-section of the connecting portion <NUM> may be substantially cylindrical or elliptical while the cross-section of the suction portion <NUM> 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 connecting portion <NUM> and the suction portion <NUM> may be designed to occur transitionally or abruptly.

In addition, the die may be designed such that the cross-section of the tube <NUM> includes surface features on an internal surface of the tube <NUM>. Example surface features are illustrated in <FIG>, wherein each branch <NUM> of the suction portion <NUM> includes a middle protrusion that extends down the length of the internal surface of the tube <NUM>. The surface features may aid the flow of air and biological materials within the tube <NUM>, which will be discussed in further detail with regards to <FIG>. By manufacturing the tube <NUM> through an extrusion process, minimal post-processing is required to form the final product of the insertable device <NUM>. Moreover, once a die is manufactured for a desired extrusion, large quantities of the extrusion may be produced at a fast rate (e.g., thousands per day), especially if the die is configured to create multiple extrusions simultaneously. This production may significantly reduce overall manufacturing costs, as well as reduce overall device complexity by reducing the number of components in the finished device. In addition, the design of the insertable device <NUM>, specifically the split state of the branches <NUM> and the bridge <NUM> that maintains separation of the branches <NUM>, provides greater design flexibility for the surface features on the channel as the branches <NUM> are not required to bend or curve substantially.

<FIG> illustrates a cross-sectional view of an extrusion <NUM> for creating the tube <NUM>, according to an embodiment. Specifically, a cross-section of the suction portion <NUM> of the tube <NUM> is shown before two halves 405a, 405b of the extrusion <NUM> are split to create the separate branches of the suction portion <NUM>. In the embodiment of <FIG>, the extrusion <NUM> includes an outer wall <NUM> and a channel <NUM>. The outer wall <NUM> forms the external boundary of the tube <NUM>. The outer wall <NUM> surrounds the channel <NUM>, through which air and biological materials can pass. As illustrated in <FIG>, the outer wall <NUM> is substantially of uniform thickness. The thickness of the outer wall <NUM> may be between approximately <NUM> to <NUM> millimeters (mm). The outer wall <NUM> includes two grooves 420a, 420b that are located on opposite edges of the outer wall. In the embodiment of <FIG>, the grooves 420a, 420b are located on an internal and external surface of the outer wall <NUM>, such that the thickness of the outer wall <NUM> narrows at the grooves 420a, 420b. As described with regards to <FIG>, the grooves 420a, 420b facilitate the separation of the two halves 405a, 405b to form the separate branches of the suction portion <NUM> of the tube <NUM>. In the embodiment of <FIG>, the grooves 420a, 420b extend down the length of the tube <NUM> for the suction portion <NUM>. In some embodiments, the connecting portion <NUM> may not include the grooves 420a, 420b and only the suction portion <NUM> includes the grooves 420a, 420b. This configuration may prevent propagating the separation of the two halves 405a, 405b into the connecting portion <NUM>. For embodiments in which the grooves 420a, 420b extend down the length of the tube <NUM> for the connecting portion <NUM>, the cross-sectional view shown in <FIG> also illustrates the cross-section of the connecting portion <NUM>.

In the embodiment of <FIG>, the surface of the channel <NUM> includes the following surface features: protrusions 425a, 425b and protrusions 430a, 430b, 430c, 430d. As illustrated in <FIG>, the surface features are arranged such that the cross-section of the extrusion <NUM> is substantially symmetrical. This configuration ensures that each branch of the suction portion <NUM> includes the same surface features once the extrusion <NUM> is split along the grooves 420a, 420b. The protrusions 425a, 425b are positioned at a middle portion of the channel <NUM> and protrude into the center of the channel <NUM> towards each other. The protrusions 430a, 430b, are positioned to the right of grooves 420a, 420b, respectively, and protrude towards each other, while protrusions 430c, 430d, are positioned to the left of grooves 420b, 420a, respectively, and protrude towards each other. This configuration of protrusions <NUM>, <NUM> divides the channel <NUM> into smaller channels, which provides each branch of the suction portion <NUM> with certain properties, discussed in further detail with regards to <FIG>.

<FIG> illustrates a cross-sectional view of a branch 435a of the suction portion <NUM>, according to an embodiment. Specifically, the cross-section shown is of the half 405a after the two halves 405a, 405b of the extrusion <NUM> are split to create separate branches of the suction portion <NUM>. The half 405a forms the branch 435a. While branch 435b is not shown, it is formed by the half 405b. As illustrated in <FIG>, the protrusions 425a, 430a, 430b divide the channel <NUM> into two smaller channels 440a, 440b, wherein each channel has a respective opening 445a, 445b. As described with regards to <FIG>, openings in the suction portion <NUM> allow fluid communication between the uterus and the pump <NUM>. Dividing the channel <NUM> into smaller channels 440a, 440b distributes the airflow from the pump <NUM> and increases the number of pathways by which air and biological materials can travel. Thus, if a single pathway becomes obstructed by biological materials, other pathways remain accessible, and the system <NUM> can effectively maintain a negative pressure inside the uterus. In addition, to further prevent the channels 445a, 445b from becoming obstructed, the openings 445a, 445b are located on a medial side of the respective branches <NUM> such that when the suction portion <NUM> is inserted into the uterus, the outer wall <NUM> faces the uterine wall and the openings 445a, 445b. This configuration prevents uterine tissue or other tissue from obstructing the openings 445a, 445b and preventing airflow when the pump <NUM> is actuated.

In the embodiment of <FIG>, the openings 445a, 445b are configured to allow biological materials of a certain size through the openings 445a, 445b and into the channels 440a, 440b such that these biological materials may be removed from the uterus and collected in the collection container <NUM>. In the embodiment of <FIG>, the size of each opening 445a, 445b is between approximately <NUM> to <NUM> millimeters (mm). In some embodiments, the size of each opening 445a, 445b is between <NUM> to <NUM> millimeters (mm). Openings of this size may additionally be configured to break up masses of biological material that have formed a clot. By breaking up the masses, the openings 445a, 445b are able to prevent obstruction of the airflow from the pump <NUM> and allow the biological material to be collected in the collection container <NUM>.

<FIG> illustrates a cross-sectional view of an additional embodiment of an extrusion <NUM> for creating the tube <NUM>. Specifically, a cross-section of the suction portion <NUM> of the tube <NUM> is shown before two halves 505a, 505b of the extrusion <NUM> are split to create the separate branches of the suction portion <NUM>. Similar to extrusion <NUM>, the extrusion <NUM> includes an outer wall <NUM> and a channel <NUM>. The outer wall <NUM> forms the external boundary of the tube <NUM>. The outer wall <NUM> surrounds the channel <NUM>, through which air and biological materials can pass. As illustrated in <FIG>, the outer wall <NUM> is substantially of uniform thickness. The thickness of the outer wall <NUM> may be between approximately <NUM> to <NUM> millimeters (mm). The outer wall <NUM> includes two grooves 520a, 520b that are located on opposite edges of the outer wall. Similar to grooves 420a, 420b, the grooves 520a, 520b facilitate the separation of the two halves 505a, 505b to form the separate branches of the suction portion <NUM> of the tube <NUM>. In the embodiment of <FIG>, the grooves 520a, 520b are located only on an internal surface of the outer wall <NUM>, but, in some embodiments, the grooves 520a, 520b may be located on both an internal and external surface of the outer wall <NUM>.

In the embodiment of <FIG>, the surface of the channel <NUM> includes the following surface features: protrusions 525a, 525b. As illustrated in <FIG>, the protrusions 525a, 525b are arranged such that the cross-section of the extrusion <NUM> is substantially symmetrical. This configuration ensures that each branch of the suction portion <NUM> includes the same surface features once the extrusion <NUM> is split along the grooves 520a, 520b. The protrusions 525a, 525b are positioned at a middle portion of the channel <NUM> and protrude into the center of the channel <NUM> towards each other. In the embodiment of <FIG>, each protrusion 525a, 525b has a distal end that extends in a different direction to the portion of the protrusion that extends from the outer wall. In the illustrated embodiment, this different direction of extension forms a shape similar to an umbrella, wherein each protrusion <NUM> includes a middle support structure with a curved arm extending from each side of the support structure. In other embodiments, other shapes may be formed, such as T-shaped protrusions, and so on. Regardless of the exact shape, this general configuration of protrusions 525a, 525b divides the channel <NUM> into smaller channels, which provides each branch of the suction portion <NUM> with certain properties, discussed in further detail with regards to <FIG>.

<FIG> illustrates a cross-sectional view of a branch 535a of the suction portion <NUM>. Specifically, the cross-section shown is of the half 505a after the two halves 505a, 505b of the extrusion <NUM> are split to create separate branches of the suction portion <NUM>. The half 505a forms the branch 535a. While branch 535b is not shown, it is formed by the half 505b. As illustrated in <FIG>, the protrusion 525a divides the channel <NUM> into two smaller channels 540a, 540b wherein each channel has a respective opening 545a, 545b. Similar to the embodiment of <FIG>, dividing the channel <NUM> into smaller channels 540a, 540b distributes the airflow from the pump <NUM> and increases the number of pathways by which air and biological materials can travel. In the embodiment of <FIG>, the openings 545a, 545b are distanced apart from each other due to the configuration of the protrusion 525a. Separating the openings 545a, 545b by a distance may decrease the likelihood of the openings 545a, 545b becoming obstructed by biological materials at the same time, potentially by the same mass of biological material. Thus, if a first opening becomes obstructed by biological materials, at least a second opening remains accessible, and the system <NUM> can effectively maintain a negative pressure inside the uterus. In addition, to further prevent the channels openings 545a, 545b from becoming obstructed, the openings 545a, 545b are located on a medial side of the respective branches <NUM> such that when the suction portion <NUM> is inserted into the uterus, the outer wall <NUM> faces the uterine wall and the openings 545a, 545b. This configuration prevents uterine tissue or other tissue from obstructing the openings 545a, 545b and preventing airflow when the pump <NUM> is actuated.

Similar to the embodiment of <FIG>, in the embodiment of <FIG>, the openings 545a, 545b are configured to allow biological materials of a certain size through the openings 545a, 545b and into the channels 540a, 540b such that these biological materials may be removed from the uterus and, in some embodiments, collected in the collection container <NUM>. In the embodiment of <FIG>, the size of each opening 545a, 545b is between approximately <NUM> to <NUM> millimeters (mm). Openings of this size may additionally be configured to break up a mass of biological material (e.g., a clot or clump of tissue). By breaking up the mass, the openings 545a, 545b are able to prevent obstruction of the airflow from the pump <NUM> and allow the biological material to be collected in the collection container <NUM>.

<FIG> illustrates a method for attaching the bridge <NUM> to the tube <NUM>, according to an embodiment. As illustrated in <FIG>, a first end of the bridge <NUM> is attached to a distal end of branch 235a of the suction portion <NUM>, and a second end of the bridge <NUM> is attached to a distal end of branch 235b of the suction portion <NUM>. This configuration of the suction portion of the tube <NUM> ensures that the branches <NUM> are separated and remain in a split state when inserted into the uterus.

In the embodiment of <FIG>, each end of the bridge <NUM> includes a mating protrusion 605a (605b not shown) that extends from an end of the bridge <NUM>. To secure the bridge <NUM> to the suction portion <NUM>, the mating protrusions 605a, 605b are inserted into a channel of the branches 235b, 235a, respectively. The mating protrusions 605a, 605b may be inserted with an interference fit (e.g., friction fit or press fit), an adhesive, a threaded interface, or some combination thereof. In the embodiment of <FIG>, the mating protrusions 605a, 605b are silicone bonded to the respective branches 235b, 235a.

<FIG> illustrates mating protrusion 605a that secures a first end of the bridge <NUM> to the branch 235a, according to an embodiment. The mating protrusion 605a may include a cavity <NUM> that complements surface features located on a channel of the branch 235a. In the embodiment of <FIG>, the shape of the cavity <NUM> is designed to complement the shape of the surface features described with regards to <FIG>. In this configuration, the surface feature 525a may be inserted into the cavity <NUM>, which may improve the stability and security of the attachment between the bridge <NUM> and the branch 235a. In addition, the cavity <NUM> provides a greater surface area for silicone bonding the mating protrusions 605a, 605b to the respective branches 235b, 235a. Other embodiments may have a cavity <NUM> designed to complement the shape of the surface features illustrated in <FIG> or any other channel surface feature configuration.

In some embodiments, the bridge <NUM> may be configured to transmit the airflow from the tube <NUM>. The bridge <NUM> may include channels or holes along a medial side of the bridge <NUM>, and the mounting protrusions 605a, 605b may include channels that couple the airflow of the suction portion <NUM> to the bridge <NUM>. This configuration provides additional pathways by which the airflow and/or biological materials can travel.

<FIG> illustrates an additional embodiment of an insertable device. As described with regards to <FIG>, an insertable device includes several components, such as a tube connector, a tube having a connecting portion and a suction portion, a bridge, and a seal. Each component may have a variety of designs, which will be discussed in further detail. In addition, different designs of the components may be interchangeable and combined in several ways to create different configurations of an insertable device.

<FIG> illustrates an insertable device <NUM>, according to an embodiment. In the embodiment of <FIG>, the insertable device <NUM> includes the tube connector <NUM>, the tube <NUM> having the connecting portion <NUM> and the suction portion <NUM>, the bridge <NUM>, and a seal <NUM>. Similar to the embodiment of the seal discussed with regards to <FIG>, the seal <NUM> creates a seal at the opening of the uterus. The seal <NUM> is composed of three disks 710a, 710b, 710c positioned at a distal end of the connecting portion <NUM>, adjacent to the suction portion <NUM>. Each disk <NUM> may be composed of a semi-flexible material, such as silicone, polyethylene, polypropylene, or any other suitable medical-grade material, allowing each disk <NUM> to conform to the anatomy of the uterus. The diameter of each disk <NUM> incrementally decreases such that the largest disk 710c is closest to the suction portion <NUM> and the smallest disk 710a is farthest away from the suction portion <NUM>. In this configuration, the decreasing diameters of the disks <NUM> may improve the ability of the seal <NUM> to be positioned against an opening of the uterus such that each disk <NUM> may abut the uterine wall to form a seal between the uterus and an environment external to the uterus. Having a seal including three disks <NUM> may improve the quality of the seal formed and provide redundancy in maintaining the seal. Other embodiments may include a varying number of disks that may be positioned at different distances relative to each other (e.g., two disks that are spaced farther apart or ten disks that are spaced closer together).

<FIG> illustrates an insertable device <NUM>, according to an arrangement falling outside the scope of the invention. In the arrangement of <FIG>, the insertable device <NUM> includes the tube connector <NUM>, a tube <NUM> having a connecting portion <NUM> and a suction portion <NUM>, and a seal <NUM>. Similar to the embodiment of the tube discussed with regards to <FIG>, the tube <NUM> acts as a conduit for air and biological materials. The tube <NUM> may comprise one or more channels that couple airflow from the pump <NUM> to the uterus to transmit a change in pressure inside the uterus. In the arrangement of <FIG>, the tube <NUM> is a flexible tube that is folded to form the connecting portion <NUM> and the suction portion <NUM>. The sections of the tube <NUM> forming the connecting portion <NUM> may be adjoined via an adhesive, one or more over-molded components secured around the tube <NUM>, or a heat shrink wrap placed over the tube <NUM>. Meanwhile, the suction portion <NUM> remains a loop. In this configuration, the construction of the tube <NUM> ensures that the alignment of the openings and/or channels on the medial side of the loop of the suction portion <NUM> remain facing away from the uterine wall upon insertion. In addition, this configuration eliminates the need for a connecting element (e.g., bridge <NUM>) between branches of the tube, which may decrease the cost of manufacturing the tube <NUM>. However, the rigidity of the tube <NUM> needs to be appropriately determined such that the tube <NUM> may be flexible enough to form the loop of the suction portion <NUM> yet rigid enough to prevent the suction portion <NUM> from potentially deforming and obstructing the openings and/or channels on the medial side of the loop. In addition, the design of the surface features on a surface of the channel of the tube <NUM> may be limited due to the desired curvature of the tube <NUM>.

In the arrangement of <FIG>, the suction portion <NUM> includes one or more openings <NUM> located along a medial side of the loop such that the openings <NUM> are oriented away from an interior wall of the uterus when the insertable device <NUM> is inserted. This configuration prevents uterine tissue or other tissue from obstructing the openings <NUM> and preventing airflow when the pump <NUM> is actuated. The openings <NUM> may be circular, elliptical, polygonal, or any other suitable shape that allows air and biological materials to travel through. In some arrangement, the openings <NUM> may be channels that extend along the medial side of the loop.

The seal <NUM> creates a seal at an opening of the uterus. The seal <NUM> is positioned at a distal end of the connecting portion <NUM>, adjacent to the suction portion <NUM>. In the arrangement of <FIG>, the seal <NUM> is shaped similar to a cup, wherein a bottom portion of the cup shape is configured to abut the uterine wall at an opening of the uterus upon insert of the insertable device <NUM> into the uterus. The seal <NUM> is composed of a semi-flexible material, such as silicone, polyethylene, polypropylene, or any other suitable medical-grade material, that allow the seal <NUM> to conform to the anatomy of the uterine wall.

<FIG> illustrates an insertable device <NUM>, according to an arrangement falling outside the scope of the invention. In the arrangement of <FIG>, the insertable device <NUM> includes the tube connector <NUM>, the tube <NUM> having the connecting portion <NUM> and the suction portion <NUM>, and the seal <NUM>. The insertable device <NUM> combines the tube configuration described with regards to <FIG> with the seal configuration described with regards to <FIG>.

<FIG> illustrates an insertable device <NUM>, according to an arrangement falling outside the scope of the invention. The insertable device <NUM> is an arrangement of insertable device <NUM>. In the arrangement of <FIG>, the insertable device <NUM> includes the tube connector <NUM>, the tube <NUM> having the connecting portion <NUM> and the suction portion <NUM>, the seal <NUM>, and a shield <NUM>. The shield <NUM> is a porous mesh that allows particles of a certain size to pass through the mesh. In the arrangement of <FIG>, the shield <NUM> encloses the suction portion <NUM> to prevent uterine tissue from obstructing the openings <NUM> while allowing other biological materials (e.g., blood) to pass through. The shield <NUM> may be composed of gauze, nylon, or other suitable materials that may be placed within the uterus.

<FIG> illustrates an insertable device <NUM>, according to an arrangement falling outside the scope of the invention. In the arrangement of <FIG>, the insertable device <NUM> includes the tube connector <NUM>, a tube <NUM> having a connecting portion <NUM> and a suction portion <NUM>, and a seal <NUM>.

The tube <NUM> acts as a conduit for air and biological materials. While the tube <NUM> is similar in geometry to tube <NUM>, the tube <NUM> is made of two individual tubes 780a, 780b rather than a single folded tube. Each tube 780a, 780b includes an internal channel extending down the length of the tube. In the arrangement of <FIG>, tubes 780a, 780b are positioned adjacent to each other such that a portion of the tubes 780a, 780b can be adjoined to form the connecting portion <NUM>. The tubes may be adjoined via an adhesive, one or more over-molded components secured around the connecting portion <NUM>, or a heat shrink wrap placed over the tube connecting portion <NUM>. The remaining portions of the tubes 780a, 780b are curved to mate an end of tube 780a to an end of tube 780b, forming a loop to create the suction portion <NUM>. The ends of the tubes 780a, 780b may be coupled together using a plug <NUM>. In the arrangement of <FIG>, a first end of the plug <NUM> is inserted into a channel of tube 780a, and a second end of the plug <NUM> is inserted into a channel of tube 780b. The plug <NUM> may be secured within the tubes 780a, 780b using an adhesive. The plug <NUM> may include openings or channels to form a continuous pathway for airflow and/or biological materials through the tube <NUM>. In some arrangements, the plug <NUM> may be designed to fit over the ends of the tubes 780a, 780b as a cross tube connector. For arrangements in which the suction portion of the tube comprises two separate branches that are to be connected, the connecting element (such as bridge <NUM> or plug <NUM>) can have a variety of configurations and be of any size, depending upon the rigidity of the tube and given that the connecting element appropriately mates the branches such that the openings or channels on each branch remain unobstructed and allow a vacuum to be created within the uterus upon insertion of the insertable device.

In the arrangement of <FIG>, the suction portion <NUM> includes one or more openings <NUM>. The openings <NUM> are created by skiving the external surface of the suction portion <NUM>. A skiving process carves out notches in the surface of the suction portion <NUM>. The openings <NUM> are located along a medial side of the loop such that the openings <NUM> are oriented away from an interior wall of the uterus when the insertable device <NUM> is inserted. This configuration prevents uterine tissue or other tissue from obstructing the openings <NUM> and preventing airflow when the pump <NUM> is actuated.

The seal <NUM> creates a seal at an opening of the uterus. In the arrangement of <FIG>, the seal <NUM> is a sleeve or a balloon that can be inflated once the suction portion <NUM> is positioned within the uterus. The seal <NUM> may be inserted while flattened, allowing the seal <NUM> to be properly positioned before the seal <NUM> is inflated. The seal <NUM> may be positioned within the vaginal canal, cervix, or uterus. In the arrangement of <FIG>, the seal <NUM> includes a tube <NUM> that may connect to the pump <NUM> to inflate the seal <NUM>. The seal <NUM> may be composed of silicone, polyethylene, polypropylene, or any other suitable medical-grade material.

<FIG> illustrates a cross-sectional view of an additional embodiment of an extrusion <NUM> for creating the tube <NUM>. Specifically, a cross-section of the suction portion <NUM> of the tube <NUM> is shown before two halves 805a, 805b of the extrusion <NUM> are split to create the separate branches of the suction portion <NUM>. In the embodiment of <FIG>, the extrusion <NUM> includes an outer wall <NUM>, channel <NUM>, channels 820a, 820b, and rings 825a, 825b. The outer wall <NUM> forms the external boundary of the tube <NUM>. The outer wall <NUM> encloses the channels <NUM>, 820a, 820b. As illustrated in <FIG>, the outer wall <NUM> is substantially of uniform thickness. The thickness of the outer wall <NUM> may be between approximately <NUM> to <NUM> millimeters (mm). The outer wall <NUM> includes two grooves 830a, 830b that are located on opposite edges of the outer wall <NUM>. In the embodiment of <FIG>, the grooves 830a, 830b are located on an internal and external surface of the outer wall <NUM>, such that the thickness of the outer wall <NUM> narrows at the grooves 830a, 830b. As described with regards to <FIG>, the grooves 830a, 830b facilitate the separation of the two halves 805a, 805b to form the separate branches of the suction portion <NUM> of the tube <NUM>. In the embodiment of <FIG>, once the two halves 805a, 805b are separate to form the branches of the suction portion <NUM>, the branches are curved towards each other to form a loop, wherein a first end of a first branch mates with a first end of a second branch. To secure the ends of the branches together, a pin may be inserted into the rings 825a, 825b. The pin may be adhered within the rings 825a, 825b.

Claim 1:
An insertable device (<NUM>) comprising:
a tube (<NUM>) comprising a connecting portion (<NUM>) and a suction portion (<NUM>), the connecting portion configured for coupling to a vacuum source that when actuated generates a change in pressure, and the suction portion insertable into a uterus, the suction portion comprising: a first loop comprising a plurality of openings (445a, 445b) along a medial surface of the first loop such that the plurality of openings are oriented away from the interior wall of the uterus upon insertion of the suction portion into the uterus; and
a seal (<NUM>) comprising a disk, the seal positioned along a length of the connecting portion proximal to the suction portion, the seal abutting a vaginal canal upon insertion of the insertable device and forming a seal between a vaginal opening and the uterus;
characterized in that:
the connecting portion (<NUM>) and the suction portion (<NUM>) are integrally formed of the same piece of material with the tube (<NUM>) at least partially split in half to create a first branch (235a) and a second branch (235b) of the suction portion (<NUM>), thereby exposing a channel of the tube (<NUM>) on a medial side of each branch (235a, 235b);
the first loop of the suction portion comprises the first branch (235a) and the second branch (235b) of the tube that are connected by a bridge (<NUM>) attached to a distal end of each branch.