Reusable obstetrical vacuum aspirator

Abstract

A pump assembly (1) for generating a vacuum during a medical procedure, the pump assembly comprising a pump housing defining a pump chamber and further having an air inlet and an air outlet in fluid communication with the pump chamber. The pumping member is disposed on or in the pump housing and is configured to increase and decrease an interior volume of the pump chamber. A chamber cover is disposed on an outer side of the pump housing and covers a portion of the pump housing, where the chamber cover includes an inlet flap extending above the air inlet, where the air inlet and the inlet flap constitute a one-way valve configured to cause inlet air to flow into the pump chamber when an internal volume of the pump chamber increases.

Description

Technical Field

[0001] This invention relates to a reusable obstetric vacuum aspirator that enables an operator to assist a mother in childbirth. The invention also relates to a reusable medical pump assembly for use in such a reusable obstetric vacuum aspirator, but also to other medical applications. Background Technology

[0002] Over the past 10-15 years, there has been a shift towards using vacuum suction instead of forceps to assist vaginal delivery. Vaginal delivery can be assisted when the second stage of labor is not progressing smoothly. This may be due to an exhausted mother or the baby becoming increasingly distressed. Today, various variants of vacuum suction devices, such as electric vacuum suction machines or disposable vacuum suction machines, are used globally for assisted vaginal delivery. Electric vacuum suction machines are relatively expensive to purchase, so they are not affordable for everyone. Disposable vacuum suction machines require less upfront investment, but are more expensive per use, have a greater environmental impact, and are sometimes reused after delivery to save costs, posing risks to the patient. Various concepts have been proposed in this field.

[0003] WO02088546A1 discloses an obstetric vacuum aspirator and a connected handheld pump assembly, wherein the pump subassembly includes a diaphragm. The diaphragm is configured to evacuate through an inlet valve to create a vacuum within the aspirator disc. The diaphragm is deflected by moving a handle from a first position to a second position. The handle is biased in the first position by a plastic spring. The obstetric vacuum aspirator also includes a pressure gauge and a safety valve to connect the interior of the disc to the atmosphere.

[0004] The drawback of WO02088546A1 is the complexity of the pump unit. The pump unit comprises multiple independent components with various channels, interconnections, inaccessible crevices, and complex shapes. Furthermore, the pump unit includes a pressure gauge. These components are difficult, if not impossible, to clean after each use, rendering the device unusable. Using the WO02088546A1 device during childbirth will deliver bodily fluids into or onto the device. The device must be completely reprocessed before reuse to prevent infection. The cleaning issues appear to make responsible reuse of the device impossible. Even a single use of the WO02088546A1 device has a negative environmental impact and appears to make its use prohibitively costly.

[0005] CN115553897A discloses another example of an obstetric vacuum aspirator. The obstetric vacuum aspirator of CN115553897A includes a suction cup, a sleeve assembly, and a piston cylinder pump. The piston cylinder pump is operated by a handheld section including a piston rod and a handle. The aspirator also includes an electronic system with a display, an integrated circuit board, and a battery.

[0006] One drawback of the suction device described in CN115553897A is its complexity. The electronic systems appear to make the device unnecessary, complex, and expensive. Furthermore, this suction device makes it impossible to reprocess each component after each use during childbirth. Therefore, the suction device seems unsuitable for reuse. This results in an expensive device with a significant environmental impact.

[0007] Another drawback of the suction device in CN115553897A is the rigid sleeve assembly between the suction cup and the piston cylinder pump. The position of the fetus during delivery can vary considerably. The fetal position also affects the placement of the suction cup on the fetal head and the direction of the pulling force required to assist delivery. The rigid connection between the suction cup and the pump limits the device's usability and reduces its versatility.

[0008] CN113476121A discloses an obstetric vacuum aspiration device, which includes a main structure, a display component, and an absorption component. The absorption component includes a suction cup connected to the fetal head and a metal-shaped flexible tube. By pressing a rubber balloon, a vacuum is generated between the suction cup and the fetal head. The vacuum level data can be monitored using the display screen. The aspiration device also includes a Bluetooth module and a communication module.

[0009] For the same reasons, CN113476121A has similar drawbacks to the suction devices of WO02088546A1 and CN115553897A. The CN113476121A suction device is also complex, expensive, and difficult to dispose of. Another disadvantage of CN113476121A is its ease of use. The pumping mechanism is separate from the body. Therefore, two hands are required to create a vacuum while holding the suction device in the correct position. Furthermore, the suction device lacks a comfortable grip for applying force. The cylindrical body may become slippery due to bodily fluids, potentially making it difficult to apply the force needed to assist in childbirth.

[0010] Another example of an obstetric vacuum aspirator is disclosed in WO9958071A1. The aspirator of WO9958071A1 combines a pump and a handle into a single handheld unit. The handle has a surface for gripping and is connected to a vacuum disc body. The pump is a piston pump within the single handheld unit. Compression of the pump's activation surface relative to the handle causes the piston to expel fluid to the atmosphere through a valve.

[0011] The drawback of the WO9958071A1 suction device is that it is designed as a disposable obstetric vacuum suction device. Disposability reduces the unit price, but it doesn't seem to reduce the price per use. In fact, disposable often leads to a higher price per use. This poses additional risks to less affluent groups. These groups may be able to afford the suction device, but in order to cut costs, they may attempt to use it multiple times. Since the WO9958071A1 suction device is not designed for reprocessing, this could potentially lead to serious health hazards. Furthermore, even a single use of these suction devices has a significant environmental impact.

[0012] One object of the present invention is to overcome at least one of the above-mentioned disadvantages and to provide an improved obstetric vacuum aspiration device to assist in childbirth.

[0013] After childbirth, mothers may experience postpartum hemorrhage (PPH), also known as postpartum hemorrhage. The most common manifestation of this condition is poor uterine contraction after delivery (known as uterine atony). Currently, devices such as uterine balloon tamponade (UBT) are available for treating PPH. The disadvantages of this device are its relatively high cost and its limited use for treating PPH.

[0014] Another object of the present invention is to overcome at least one of the above-mentioned disadvantages and to provide a vacuum-induced bleeding control system for treating postpartum hemorrhage. Summary of the Invention

[0015] At least one of the above objectives is achieved by the pump assembly according to claim 1.

[0016] One particular aspect of the invention relates to a pump assembly for generating a vacuum between the fetal head and the suction cup of an obstetric vacuum aspirator, the pump assembly comprising: - Pump housing, which defines a pump chamber and also has an air inlet and an air outlet in fluid communication with the pump chamber. - Pumping components, which are arranged on or within the pump housing and configured to increase or decrease the internal volume of the pump chamber. - A chamber cover is disposed on the outside of the pump housing and covers a portion of the pump housing. The chamber cover includes an inlet valve flap extending above an air inlet. The air inlet and the inlet valve flap constitute a one-way valve configured to allow inlet airflow into the pump chamber as the internal volume of the pump chamber increases.

[0017] Operators can use obstetric vacuum aspiration devices to assist mothers in vaginal delivery or cesarean section. This invention proposes a pump assembly capable of creating a vacuum between the suction cup and the fetal head. When the pumping member is in its default position, the internal volume of the pump chamber is small. The pumping member seals one side of the pump chamber. Moving the pumping member in the opposite direction to the chamber cover increases the volume of the pump chamber.

[0018] The pumping component can be configured to move in a direction other than the direction opposite to the chamber cover to increase the volume of the pump chamber.

[0019] According to Boyle's Law, pressure decreases as volume increases. Therefore, a volume with lower pressure appears within the pump chamber. A volume with higher pressure remains between the suction cup and the fetal head. Airflow will occur from the higher-pressure volume to the lower-pressure volume. A one-way inlet valve allows air to flow along the direction of the pump chamber. The airflow will continue until pressure equilibrium is achieved between the two volumes. Now, the pressure in both volumes is lower than ambient pressure. This ensures proper contact between the suction cup and the fetal head.

[0020] In some embodiments, the pump assembly also includes a handpiece attached to or as part of the housing.

[0021] In some embodiments, the pump assembly further includes a manually operated actuator that can be moved relative to the pump housing from a first position to a second position, or from a second position to a first position, wherein the manually operated actuator is coupled to the pumping member such that when the manually operated actuator moves from the first position to the second position, the internal volume of the pump chamber increases.

[0022] In some embodiments, the pumping component is a diaphragm.

[0023] In some embodiments, the diaphragm is elastic and releasably connected to the pump housing.

[0024] The diaphragm is elastic, allowing the volume of the pump chamber to increase and decrease. This elasticity also forces the manually operated actuator to remain in its default position.

[0025] When connected to the pump housing, the diaphragm and the pump housing form an airtight seal.

[0026] In some embodiments, the manually operated actuator is pivotable about an actuator pivot axis, wherein the manually operated actuator is biased into a first position by the elasticity of the diaphragm.

[0027] The diaphragm's elastic bias force, along with the shape of the handle, allows for one-handed operation of the pump assembly. This is important because operators often need a second hand to place the disc on the fetal head or perform other procedures.

[0028] In some embodiments, the pump assembly further includes: - A diaphragm connecting member, positioned in the center of the diaphragm, wherein the diaphragm connecting member is configured to connect with an actuator connecting member. -Actuator connecting member, positioned on top of the manually operated actuator. In some embodiments, a manually operated actuator can be disconnected from the diaphragm to disassemble the pump assembly.

[0029] The manually operated actuator is advantageously disconnectable for easy reprocessing. In some embodiments, the chamber cover may also include an outlet valve flap extending above the air outlet, wherein the air outlet and the outlet valve flap constitute a one-way valve configured to allow the outlet airflow to flow out of the pump chamber while reducing the internal volume of the pump chamber.

[0030] When the operator moves the manually operated actuator from the second position to the first position, the internal volume of the pump chamber decreases again. The air inside the pump chamber needs to find an exit path of least resistance. The one-way inlet valve only allows airflow into the pump chamber, so air cannot flow back into the suction cup. The one-way outlet valve allows airflow out of the pump chamber and into the environment.

[0031] By designing the chamber cover as a one-way valve that allows both airflow out and in, the obstetric vacuum aspirator requires fewer individual components. Fewer components reduce system complexity. The obstetric vacuum aspirator can be advantageously disassembled for reprocessing, enabling its reuse. Disassembling fewer components saves time, makes it easier to manage, and reduces the risk of lost or misplaced parts.

[0032] The inlet and outlet valves can be configured to act in opposite directions. This can be achieved by placing the inlet and outlet valves at opposite ends of the air inlet and air outlet. In such an embodiment, the pump assembly will generate overpressure instead of vacuum. This can be beneficial in certain medical procedures.

[0033] The aforementioned feature of the chamber cover, including an outlet valve flap extending above the air outlet, can also be used independently of other features of the chamber cover in other embodiments of the chamber cover. Thus, for example, according to another aspect of the invention, a pump assembly is provided for generating a vacuum, for example, between the fetal head and the suction cup of an obstetric vacuum aspirator, the pump assembly comprising: - Pump housing, which defines a pump chamber and also has an air inlet and an air outlet in fluid communication with the pump chamber. - Pumping components, which are arranged on or within the pump housing and configured to increase or decrease the internal volume of the pump chamber. - A chamber cover is disposed on the outside of the pump housing and covers a portion of the pump housing. The chamber cover also includes an outlet valve flap extending above the air outlet. The air outlet and the outlet valve flap constitute a one-way valve, which is configured to allow the outlet airflow to flow out of the pump chamber while reducing the internal volume of the pump chamber.

[0034] In some embodiments, the pump housing further defines an air passage that connects an air inlet to a passage inlet.

[0035] In some embodiments, the pump housing includes a cylindrical wall defining a pump chamber.

[0036] In some embodiments, the pump housing has a slot configured to receive an inlet valve of the chamber cover.

[0037] An inlet valve extends from the inner surface of the chamber cover. The extended inlet valve passes through a slot into the pump chamber and covers the chamber inlet. The valve can bend towards the interior of the pump chamber under the influence of airflow. Therefore, the airflow from the suction cup into the chamber forces the inlet valve slightly away from the cylindrical wall, allowing airflow into the chamber. Due to the valve's position, no reverse airflow occurs. The airflow in the direction of the inlet valve causes the inlet valve to form an airtight connection with the cylindrical wall, forcing air to find an alternative path out of the pump chamber.

[0038] Lower vacuum levels can be achieved by incorporating a slot in the inlet valve that is configured to receive the chamber cover. The one-way valve's proximity to the pump chamber eliminates the potential dead volume space within the pump assembly. Dead volume prevents trapped air in the pump chamber from being completely expelled into the environment.

[0039] In some embodiments, the pump housing includes at least one protruding connecting member positioned on an outer surface of the pump housing, and the chamber cover has at least one corresponding recess, wherein the at least one protruding connecting member and the at least one recess are configured to engage with each other to secure the chamber cover to the pump housing. Alternatively, the pump housing may have a recess and the chamber cover may have a corresponding protruding connecting member.

[0040] At least one protruding connecting member and a corresponding recess provide an easy connection between the chamber cover and the pump housing.

[0041] In some embodiments, the pumping component is positioned relative to the chamber cover.

[0042] In some embodiments, the chamber cover includes a channel recess, and the channel recess and the pump housing define a connecting channel that connects the channel inlet to an air passage in fluid communication with the suction cup.

[0043] By providing a connection channel defined by the channel recess and the pump housing, it becomes more accessible. The chamber cover can be removed from the pump housing. Once removed, the surfaces of the pump chamber and the channel recess defining the connection channel are easily cleaned. Both the surfaces of the pump chamber and the channel recess are visible and can be cleaned according to different cleaning purposes. This is much easier to achieve compared to an internal channel in one of several components, which may be difficult to access and not very noticeable.

[0044] In some embodiments, the chamber cover includes a vacuum level indicator to provide information about the vacuum level achieved in the suction cup.

[0045] Operators of obstetric vacuum aspiration devices need to be able to monitor the vacuum level achieved between the fetal head and the suction cup. If the achieved vacuum level exceeds a certain limit, the suction cup may injure the fetal delicate head and / or skin. Conversely, if the achieved vacuum level is insufficient, the suction cup may detach from the fetal head when the operator applies the necessary force. Unintended detachment of the suction cup from the fetal head can occur up to three times before a cesarean section is necessary. Disconnection can also injure the fetal head.

[0046] The aforementioned features of the chamber cover, including the vacuum level indicator, can also be used independently of other features of the chamber cover in other embodiments of the chamber cover. Therefore, for example, according to another aspect of the invention, a pump assembly for generating a vacuum between the fetal head and the suction cup of an obstetric vacuum aspirator is provided, the pump assembly comprising: - Pump housing, which defines a pump chamber and also has an air inlet and an air outlet in fluid communication with the pump chamber. - Pumping components, which are arranged on or within the pump housing and configured to increase or decrease the internal volume of the pump chamber. - A chamber cover, which is disposed on the outside of the pump housing and covers a portion of the pump housing, wherein the chamber cover includes a vacuum level indicator to provide information about the vacuum level achieved in the suction cup.

[0047] In some embodiments, the branch channel connects a vacuum level indicator to the connection channel.

[0048] Just like the connecting channel, the branch channel can be defined by the chamber cover and the pump housing. Therefore, the advantages of the connecting channel also apply to the branch channel. For the sake of simplicity, these advantages will not be repeated. The branch channel also provides direct fluid communication between the suction cup and the vacuum level indicator.

[0049] In some embodiments, the vacuum level indicator includes at least one deformable member formed in a chamber cover, wherein the at least one deformable member extends outward from the outer surface of the chamber cover, and wherein the at least one deformable member is allowed to deform during use by a certain level of vacuum generated below the at least one deformable member.

[0050] The use of an integrated deformable member in the chamber cover adds another function to the chamber cover. In this way, the number of individual components is further reduced. Furthermore, compared to, for example, a pressure gauge, the deformable member provides a very basic implementation of a vacuum level indicator. This further reduces the complexity of the obstetric vacuum aspirator.

[0051] In some embodiments, the vacuum level indicator includes a plurality of deformable members.

[0052] In some embodiments, each deformable member deforms at different vacuum levels due to different wall thicknesses, different dimensions, different shapes, and / or additional reinforcements.

[0053] Multiple deformable elements can be combined with visible markings such as color maps or visible numbers to associate a specific vacuum level achieved with the deformation of one or more of the multiple deformable elements. This provides the operator with a clear and simple overview.

[0054] In some embodiments, the deformable member may be dome-shaped.

[0055] In some embodiments, interconnecting channels provide fluid communication between multiple deformable components.

[0056] In some embodiments, the indicator opening connects a vacuum level indicator to an air passage.

[0057] In some embodiments, the vacuum level indicator includes: - A bellows, which is in fluid communication with a suction cup through an indicator opening, wherein the bellows is configured to expand or compress during use according to the pressure difference between ambient pressure and a vacuum generated within the bellows, and wherein the bellows comprises: o First bellows end, and The second bellows end is configured to connect to the vacuum level indicator connector opening of the chamber cover, and - A bellows spring, wherein the bellows spring includes a first spring end configured to be connected to a first bellows end and a second spring end configured to be connected to a chamber cover of the pump assembly, wherein the bellows spring is configured to hold the first bellows end relative to the chamber cover in a first bellows position when no vacuum is generated in the bellows.

[0058] Bellows can be combined with an index consisting of visible markings such as color charts or visible numbers to correlate a given vacuum level with the bellows' deformation. This provides the operator with a clear and simple overview.

[0059] The bellows and bellows spring can be connected as a single unit. This provides the benefit of reducing the number of parts, making it easy to assemble and disassemble for purposes such as sterilization by an operator.

[0060] Vacuum level indicator, inlet valve, outlet valve and chamber cover, including bellows and bellows spring, can be integrally connected to form a single component.

[0061] In some embodiments, the first bellows end includes at least one first bellows end connecting element, and the bellows spring includes a first spring end connector, wherein the first spring end connector includes at least one first spring end connector slot configured to receive at least one first bellows end connecting element for connecting the first spring end to the first bellows end.

[0062] The first bellows end connector and the first spring end connector can form a bayonet connection. Other types of connectors are also possible, such as snap-fit ​​connectors, threaded connectors, Luer lock connectors, or magnetic connectors.

[0063] In some embodiments, the second spring end includes a clamp configured to removably attach the second spring end to the chamber cover.

[0064] In some embodiments, the vacuum level indicator includes a vacuum pressure gauge, particularly an analog vacuum pressure gauge, to correlate the deformation of the bellows with the vacuum level in the suction cup.

[0065] The spring force transmitted by the bellows spring is configured such that the deformation of the bellows due to expansion or compression will give a reading on the vacuum gauge corresponding to the vacuum level generated inside the bellows.

[0066] In some embodiments, the bellows includes at least one reinforcing ring spaced apart along the centerline of the bellows.

[0067] In some embodiments, the bellows includes a reinforcing spiral, wherein the centerline of the reinforcing spiral coincides with the centerline of the bellows.

[0068] In some embodiments, the chamber cover includes a chamber cover connecting member with a protrusion, and the pump housing includes a corresponding connecting recess on the outer surface of the pump housing, wherein the protrusion and the connecting recess are configured to engage with each other to secure the chamber cover to the pump housing. Alternatively, the chamber cover may have a connecting recess and the housing may have a corresponding protrusion.

[0069] In some embodiments, the chamber cover includes a release tab configured to at least partially lift the chamber cover from the pump housing to release the vacuum from the connecting channel, thereby ultimately releasing the vacuum between the fetal head and the suction cup.

[0070] This adds another function to the chamber cover. The release tab provides a simple solution for releasing the vacuum. This can be operated by lifting the release tab with one hand. This also eliminates the need for a separate controllable safety valve, which can be difficult to clean and unnecessarily complicates the obstetric vacuum aspirator.

[0071] In some embodiments, the chamber cover is a flexible plate made of an elastic material, particularly silicone rubber.

[0072] In some embodiments, the chamber cover may include a release plug configured to release vacuum in the suction cup. The plug formed on the chamber cover may be received in a release opening in the housing. When the plug is pulled out of the opening, the vacuum is released.

[0073] In some embodiments, the housing or handheld portion includes a first connecting member configured to connect with a second connecting member of the tube.

[0074] This invention also relates to an obstetric vacuum aspiration device for assisting mothers in vaginal delivery of fetuses, the obstetric vacuum aspiration device comprising: -The pump assembly according to the invention, - A suction cup, which is configured to be applied to the fetal head. - A tube used to fluidly connect the diaphragm pump assembly to the suction cup.

[0075] In some embodiments, the air inlet of the pump chamber is in fluid communication with the tubular fluid through an air passage in the housing or handheld part.

[0076] The position of the first connecting member is important because the operator should be able to apply force to the suction cup and tube with one hand. The air passage provides design freedom, allowing the optimal position of the first connecting member to be selected based on its intended use.

[0077] In some embodiments, the tube is a flexible tube.

[0078] In some embodiments, the suction cup connector between the tube and the suction cup is a flexible connector configured to provide the operator with greater freedom to apply force in different directions.

[0079] The flexible tube and flexible connector provide complete freedom of motion to apply force to the suction cup and the fetal head in different directions. The position of the fetal head varies greatly, and different positions require movement of the fetal head in different directions to assist in delivery.

[0080] In some embodiments, the suction cup includes at least one vacuum chamber.

[0081] In some embodiments, the suction cup may include an inner disk element on the wall of the vacuum chamber, the inner disk element being configured to provide equal vacuum pressure throughout the vacuum chamber.

[0082] When a vacuum is created, objects such as a fetal head may completely or partially block the air inlet of the maternity vacuum connector. Therefore, the subsequent vacuum pressure generated by the pump assembly will act only or primarily on the portion of the object that completely or partially blocks the air inlet. Even if the object is located at or near the air inlet, the inner disc element allows airflow from the suction cup's vacuum compartment to the air inlet, thus creating equal vacuum pressure throughout the vacuum compartment. This equal vacuum pressure results in a more even grip on the object.

[0083] Another aspect of the present invention relates to a method for assisting a mother in delivering a fetus using an obstetric vacuum aspiration device as described above, wherein the method includes: - Apply the suction cup to the fetal head. -A vacuum is created in the vacuum chamber of the suction cup. - Apply force to the shell or handle to assist the mother during childbirth. -Release the vacuum from the vacuum compartment of the suction cup. - Remove the suction cup from the fetal head.

[0084] This method offers the same advantages as the device.

[0085] Another aspect of the present invention relates to a method for reprocessing an obstetric vacuum aspirator as described above, wherein the method comprises: -Disassemble the obstetric vacuum aspirator. Clean each component of the obstetric vacuum aspiration device. - Sterilize every component of the obstetric vacuum aspiration device. - Reassemble the obstetric vacuum aspirator - Sterilize the obstetric vacuum suction device. Each component of the obstetric vacuum aspirator conforms to ISO 17665, ISO 18472 and ISO 20957 standards to withstand sterilization processes, thus enabling the obstetric vacuum aspirator to be reused.

[0086] The reusability of obstetric vacuum aspiration devices significantly improves the sustainability of the equipment. This also allows for an increase in the price of the equipment itself, while reducing the cost per use, making it more affordable for a wider range of people.

[0087] The present invention also relates to an obstetric vacuum connector for connecting a pump assembly to a suction cup of an obstetric vacuum aspirator, the obstetric vacuum connector comprising: - A flexible tube for fluidly connecting a pump assembly to a suction cup, wherein the tube has a wall defining an air conduit and also has an inlet and an outlet. - A first connecting member, attached to a first side of the flexible tube and configured to connect the flexible tube to the pump assembly. At least one wire is incorporated into the wall, and the wire is configured to resist tension applied to the suction cup via the tube.

[0088] By integrating the filament into the wall of the flexible tube, the wall does not need to be rigid to withstand the forces applied to the suction cup. Integrating it into the wall also ensures that no bodily fluids come into contact with the filament. This makes cleaning the obstetric vacuum aspirator much easier.

[0089] In some embodiments, the second connecting member is attached to a second side of the flexible tube and configured to connect the flexible tube to the suction cup.

[0090] In some embodiments, the tube is made of an elastic material, particularly silicone rubber.

[0091] In some embodiments, at least one wire is embedded in the wall.

[0092] In some embodiments, at least one wire may be made of an aromatic polyamide (also known as a para-aromatic polyamide, such as Kevlar® or Twaron®).

[0093] In some embodiments, the tube has a central axis, and at least one wire extends substantially parallel to the central axis.

[0094] The wire is essentially parallel to the central axis of the tube, which prevents the flexible tube from curling up when no tension is applied.

[0095] In some embodiments, the first connecting component includes a first anchor, and the second connecting component includes a second anchor, wherein at least one wire is connected to the first anchor and the second anchor.

[0096] In some embodiments, at least one wire comprises multiple wires arranged rotationally symmetrically within the wall relative to the central axis of the tube.

[0097] Multiple wires are arranged in a rotationally symmetrical manner to distribute the force applied to the flexible tube evenly. This provides the operator with better control.

[0098] In some embodiments, the wall is a tubular wall.

[0099] In some embodiments, the second anchor is attached to the suction cup.

[0100] It should be noted that the aforementioned connector can be conceived to be used in other applications besides obstetric vacuum aspirators, particularly in medical applications where the medium must be transported from one location to another through a tube, and where tension must be applied to the tube wall.

[0101] This invention also relates to an obstetric vacuum aspiration device for assisting mothers in vaginal delivery of fetuses, the obstetric vacuum aspiration device comprising: - Suction cups, which are configured to be applied to the fetal head. - Pump components used to generate vacuum, - As described above, the obstetric vacuum connector is used to interconnect the suction cup and the pump assembly in order to provide the suction cup with a vacuum generated by the pump assembly.

[0102] In some embodiments, the pump assembly includes a pump assembly coupling component configured to engage with a first coupling component of the obstetric vacuum connector.

[0103] In some embodiments, the suction cup has a central opening configured to connect with a second connecting member of the obstetric vacuum aspirator, wherein the circular edge of the central opening is configured to be positioned in a tubular recess of the second connecting member.

[0104] In this way, the flexible tube can be easily connected to and disconnected from the suction cup, while providing an airtight connection between the suction cup and the flexible tube.

[0105] In some embodiments, the obstetric vacuum connector can be disconnected from the pump assembly to remove the obstetric vacuum aspirator.

[0106] In some embodiments, the obstetric vacuum connector can be disconnected from the suction cup to remove the obstetric vacuum aspirator.

[0107] Another aspect of the present invention relates to a method for manufacturing an obstetric vacuum connector, the method comprising: - Provide at least one wire in the mold. - Tension the at least one wire in the mold. - Cast material around a portion of the wire for the first anchor, and cast material around a portion of the wire away from the first anchor for the second anchor. - Cast silicone resin material into the mold such that the wire, at least between the first and second anchors, is embedded in the silicone resin material. - Provide a molding core in the mold to form a tube from silicone material. - Remove the mold and molded core.

[0108] Another aspect of the present invention relates to a method for manufacturing an obstetric vacuum connector, the method comprising: - Cast the material for the first and second anchors in the first mold. Remove the first and second anchors from the first mold, and place the first and second anchors into the second mold. - At least one wire is provided in the second mold, wherein the at least one wire is connected to the first anchor and the second anchor. - Provide a molding core in the mold to form a tube from the cast silicone material. - Tension at least one wire in the mold. - Cast silicone resin material into a mold, such that the at least one wire is embedded in the silicone resin material. - Remove the mold and molded core.

[0109] The two methods described above offer the same advantages as this device.

[0110] In embodiments of the method, silicone resin material is partially cast around the first anchor and the second anchor.

[0111] In an embodiment of the method, the suction cup is cast next to the obstetric vacuum connector, thereby forming an integral connection between the obstetric vacuum connector and the suction cup.

[0112] In some embodiments, the pump assembly can generate a vacuum in the vacuum chamber of the suction cup by moving a manually operated actuator from a first position to a second position.

[0113] In some embodiments, the medical procedure may include creating a vacuum between the fetal head and the suction cup of an obstetric vacuum aspirator.

[0114] On the other hand, the pump assembly can be used in other medical applications requiring vacuum pumping action (i.e., applications other than creating a vacuum between the fetal head and the suction cup of an obstetric vacuum aspirator). These other medical applications can be found both within and outside the obstetric subfield. The pump assembly can, for example, be used for vacuum-induced hemorrhage control to treat postpartum hemorrhage (PPH), a potentially life-threatening condition.

[0115] Medical procedures may include treatment of postpartum hemorrhage, particularly through vacuum-induced hemorrhage control.

[0116] Other applications for pump components are also conceivable, such as in suction devices to remove bodily fluids, such as blood, wound secretions, etc.

[0117] The present invention will be further explained below with reference to the accompanying drawings and specific embodiments. Attached Figure Description

[0118] Figure 1 An isometric view of the obstetric vacuum aspirator according to the present invention is shown; Figure 2 and Figure 3 An isometric view of a disassembled obstetric vacuum aspirator is shown; Figure 4 A side view of the disassembled obstetric vacuum aspirator is shown; Figures 5a to 5d A cross-sectional side view of an obstetric vacuum aspiration device is shown; Figures 6a to 6b An isometric view of an obstetric vacuum aspirator is shown; Figure 7 An isometric top view of the chamber cover is shown; Figure 8 An isometric bottom view of the chamber cover is shown; Figure 9a A top view of the chamber cover and vacuum level indicator is shown; Figure 9b A bottom view of the chamber cover and vacuum level indicator is shown; Figure 10 It shows Figure 1 A cross-section of a portion of an obstetric vacuum aspirator, but without a chamber cover and diaphragm; Figure 11 It shows Figure 10 A cross-section of a portion of an obstetric vacuum aspirator, but with a chamber cover and diaphragm; Figure 12 It shows Figure 10 Another cross-section of a part of an obstetric vacuum aspirator, but with a chamber cover and diaphragm; Figure 13 An isometric view of the obstetric vacuum connector is shown; Figure 14 A side view of the obstetric vacuum connector is shown; Figure 15 A cross-sectional side view of an obstetric vacuum connector is shown; Figures 16a to 16b A cross-sectional view of the flexible tube is shown; Figure 17 A cross-sectional view of another obstetric vacuum connector is shown; Figure 18 A cross-sectional view of the flexible tube is shown; Figure 19 Isometric views of different embodiments of the pump assembly are shown; Figure 20 Isometric views of an obstetric vacuum aspirator, including different embodiments of the pump assembly, an obstetric vacuum connector, and a suction cup, are shown. Figure 21 It shows Figure 20 Isometric view of the disassembled obstetric vacuum aspirator; Figure 22 It shows Figure 20 Side view of a disassembled obstetric vacuum aspirator; Figures 23a to 23b Cross-sectional side view, front view and side view of an alternative embodiment of the pump assembly are shown; Figures 24a to 24b It shows Figures 23a to 23b The corresponding pump assembly, wherein the bellows of the pump assembly is in a compressed or deformed position; Figures 25a to 25b A side view and cross-sectional view of the integrally connected obstetric vacuum connector and suction cup are shown; Figures 26a to 26b Shown in different side views and cross-sectional views Figures 25a to 25b An integrated obstetric vacuum connector and suction cup; Figures 27a to 27c The obstetric vacuum connector tube is shown in a side view, a cross-sectional view, and a bottom view of the suction cup. Figures 25a to 25b An integrated obstetric vacuum connector and suction cup; Figures 28a to 28b A side view and cross-sectional view of an embodiment of the obstetric vacuum connector and suction cup are shown; Figure 29 An alternative embodiment of a pumping assembly with a reinforced auger is shown; Figures 30 to 31 An alternative embodiment of a vacuum level indicator for an obstetric vacuum aspirator is shown, wherein the bellows, bellows spring, and chamber cover are integrally connected. Detailed Implementation

[0119] One aspect of the invention disclosed herein relates to a pump assembly for generating a vacuum in a medical procedure, wherein the pump assembly includes a pump housing defining a pump chamber and further has an air inlet and an air outlet in fluid communication with the pump chamber. The pump assembly also includes a pumping member disposed on or within the pump housing and configured to increase and decrease the internal volume of the pump chamber. Furthermore, the pump assembly includes a chamber cover disposed on the outside of the pump housing and covering a portion of the pump housing, wherein the chamber cover includes an inlet valve flap extending above the air inlet, wherein the air inlet and the inlet valve flap constitute a one-way valve configured to allow inlet airflow into the pump chamber as the internal volume of the pump chamber increases.

[0120] Go to Figures 1 to 4This illustration shows a specific embodiment of a pump assembly 1 used to create a vacuum between the fetal head and the suction cup 20 of an obstetric vacuum aspirator 10. The pump assembly 1 in this embodiment is a diaphragm pump assembly. The diaphragm pump assembly 1 includes a pump housing 30, a diaphragm 36, an actuation handle 42, and a chamber cover 50. The pump housing 30 is attached to the handle 40. The housing 30 has a cylindrical wall 31 and a bottom at one end of the housing. The other end of the housing 30 is open. The diaphragm 36 is arranged at the open end of the housing 30. The chamber cover 50 is arranged on the outer side 39 of the bottom of the housing 30.

[0121] It should be noted that in this detailed description, the invention is illustrated with reference to a diaphragm pump assembly. However, other pump types with a pumping component other than a diaphragm (such as a piston) are also conceivable to cooperate with the other components of the pump assembly described herein.

[0122] The handle 40 includes a first connecting member 48 configured to connect with a second connecting member 92 of the tube 90. The first and second connecting members can form a bayonet connection, or they can form different connections. This connection allows the components to be easily connected and disconnected. The connection also allows the tube 90 to be connected to the bottom of a suction cup pointing in different directions.

[0123] Go to Figures 5a to 5c A cross-sectional view of diaphragm pump assembly 1 is shown. Figures 10 to 12 Another cross-sectional view is shown. Pump housing 30 defines pump chamber 32. Pump housing 30 also has air inlet 34 and air outlet 35. Air inlet 34 and air outlet 35 are in fluid communication with pump chamber 32. Diaphragm 36 is elastic and releasably connected to cylindrical wall 31 of housing 30. Edge of diaphragm 36 engages with edge of cylindrical wall 31. Edge of cylindrical wall has a protruding periphery 31A (see...). Figure 10 The periphery engages with the diaphragm 36 to attach the diaphragm 36 to the wall 31 of the housing 30. The diaphragm 36, disposed on the pump housing 30, is configured to increase and decrease the internal volume of the pump chamber 32. An actuation handle 42 is coupled to the diaphragm 36 such that the diaphragm 36 moves together with the actuation handle 42. When the actuation handle 42 moves from a first position 44 to a second position 45, the internal volume of the pump chamber 32 increases due to the deformation of the diaphragm 36. The handle 40 also includes hollow internal sections 43. These internal sections 43 reduce the overall weight of the assembly 1.

[0124] By moving the actuation handle 42 relative to the pump housing 30 from a first position 44 to a second position 45, the internal volume of the pump chamber increases and decreases, and vice versa. The actuation handle 42 is pivotable about a handle pivot 46, and the actuation handle is biased to the first position by the elasticity of the diaphragm. The biasing force of the diaphragm's elasticity can be further enhanced by a spring in the handle portion. The bases of the actuation handle 42 and the handle portion 40 have similar shapes. Together, the actuation handle and the base of the handle portion form the shape of pliers, thus being ideal for operation and gripping with one hand by the operator. The biasing force of the diaphragm's elasticity further facilitates this.

[0125] A diaphragm 36 is disposed at one end of the pump housing. A bottom 33 is formed at the opposite end of the pump housing 30. A chamber cover 50 is disposed on the outside of the bottom 33 of the pump housing 30. The chamber cover 50 includes an inlet valve disc 52 that is upright relative to the body of the chamber cover 50. The valve disc extends along the inner side of the wall 31 and is located above the air inlet 34. A recessed valve seat region 31B is provided on the inner side of the wall to receive the valve disc 52. The air inlet 34 and the inlet valve disc 52 constitute a one-way valve 53, which is configured to allow inlet airflow 12 (in Figure 11 (Indicated by the dashed arrow) During the suction stroke (i.e., when the actuation handle 42 moves from the first position to the second position), it enters the pump chamber 32. The pump housing 40 has a slot 37 in the bottom 33, which is configured to insert and pass through the inlet valve 52, such that the valve 52 extends into the chamber 32.

[0126] exist Figure 5a and Figure 5b In the diagram, the diaphragm pump assembly 1 is shown with and without a chamber cover 50. The chamber cover 50 includes an outlet valve flap 54 extending above an air outlet 35. The air outlet 35 and the outlet valve flap 54 constitute a one-way valve 55, which is configured to allow outlet airflow 13 when the actuation handle 42 is moved from a second position 45 to a first position 44. Figure 5d (Indicated by the dashed arrow) Exits the pump chamber 32.

[0127] Figure 5b The actuation handle 42 is shown in the first position 44. Figure 5cThe actuation handle 42 is shown in the second position 45, resulting in the maximum volume of the pump chamber 32. This increase in chamber volume induces an airflow into the chamber. A one-way outlet valve 54 prevents airflow from the environment into the chamber. The negative pressure in the valve chamber 32 caused by the increased chamber volume causes the valve disc 52 to move away from the valve seat 31B, allowing air from the suction cup to be drawn into the chamber via the air inlet 34. Air flows from the relatively high-pressure volume inside the suction cup to the low-pressure volume within the pump chamber, thereby reducing the pressure inside the suction cup. Repeated suction steps create a partial vacuum between the suction cup and the fetal head. When the actuation handle 42 moves from the second position 45 to the first position 44, the chamber volume decreases, thereby increasing the pressure in the chamber 32. This increased pressure pushes the valve disc 52 against the valve seat 31B, thereby closing the air inlet 34. The increased pressure will eventually become high enough to push the outlet valve disc 54 away from its seat and allow air to escape from the pump chamber 32 through the air outlet 35.

[0128] The pump housing defines an air passage 131 that connects air inlet 34 to passage inlet 132, such as... Figure 10 and 12 As shown.

[0129] return Figure 3 and Figure 4 The pump housing 30 includes at least one protruding member 38 positioned on the outer surface 39 of the bottom 33 of the pump housing 30. The outer surface 39 of the housing 30 is positioned at one end of a cylindrical wall. The chamber cover 50 has at least one corresponding recess 56. At least one protruding connecting member 38 and the at least one recess 56 are configured to engage with each other to secure the chamber cover 50 to the pump housing 30. The housing 30 may also include a plurality of protruding members 38 distributed on the surface of the housing 30. The cover 50 of the housing 30 includes an equal number of recesses, each of which corresponds to a protruding member on the outer surface. One or more connection points ensure that the cover 50 remains in the correct position throughout operation.

[0130] Go to Figures 7 to 9bThe chamber cover 50 is shown separately. The chamber cover 50 includes a channel recess 60. The channel recess 60 and the pump housing 30 define a connection channel 62 that connects the channel inlet 132 to an air passage 41. The air passage 41 is in fluid communication with the suction cup 20. The chamber cover 50 also includes a vacuum level indicator 70 to provide information about the vacuum level achieved in the suction cup. A branch channel 68 connects the vacuum level indicator 70 to the connection channel 62. This fluidly connects the vacuum indicator 70 to both the suction cup 20 and the chamber 32. The vacuum indicator is fluidly connected to the chamber via the channel 132 and a one-way inlet valve. It is directly connected to the suction cup via the air passage 41 and a hose 90 to provide direct information about the vacuum achieved between the suction cup 20 and the fetal head.

[0131] The vacuum level indicator 70 includes at least one deformable member 72 formed in the chamber cover 50. The at least one deformable member 72 extends outwardly from the outer surface 74 of the chamber cover 50. During use, the at least one deformable member 72 is allowed to deform by a vacuum generated beneath it. The vacuum level indicator 70 may also include multiple deformable members 72. The deformable members 72 may be dome-shaped or any other shape, such as a triangle or a square. Each deformable member 72 has a different wall thickness to deform at different vacuum levels. Deformation at different vacuum levels can also be achieved by using deformable members with constant wall thickness but different sizes, shapes, and / or by adding additional support elements (such as ribs). Interconnecting channels 69 provide fluid communication between the multiple deformable members 72.

[0132] The thickness, size, and shape of the walls of a deformable member indicate a certain degree of elasticity. The reduced air pressure inside the deformable member decreases the force exerted on each member from the inside, while the force from ambient pressure to the outside of the deformable member remains constant. When the air pressure below the deformable member reaches a certain lower limit, the deformable member will deform due to the force of the ambient pressure.

[0133] Go to Figures 6a to 6b The diagram illustrates the operating principle of the chamber cover 50. The chamber cover 50 is a flexible plate 51 made of an elastic or flexible material, particularly silicone rubber. The cover may have a shape corresponding to the surface 39 of the housing 30, but it may also have a different shape.

[0134] Figure 6aA vacuum level indicator 70 with four deformable members 72 is shown, two of which are deformable members 73. The deformable members 73 provide the operator of the obstetric vacuum aspirator 10 with information about the vacuum level achieved between the fetal head and the suction cup 20. The chamber cover may also include a release tab 80. When the cover 50 is positioned on the outer surface 39 of the housing 30, only the release tab extends from the housing. The release tab 80 is configured to at least partially lift the chamber cover 50 from the pump housing 30 to release the vacuum from the connecting channel 62, thereby ultimately releasing the vacuum between the fetal head and the suction cup 20. Lifting the tab 80 from the housing 30 causes the flexible plate 51 to bend. When one of the channels in the chamber cover 50 is exposed to the environment, pressure balance is automatically restored.

[0135] return Figure 5a The diagram shows a diaphragm connection member 24 positioned in the center 25 of the diaphragm 36. The diaphragm connection member 24 includes a hook 26 configured to connect with an actuation handle connection member 27. The actuation handle connection member 27 is positioned at the upper portion 28 of the actuation handle 42. The actuation handle connection member 27 includes a connecting rod 29 configured to be gripped by the hook 26. The actuation handle 42 can be disconnected from the diaphragm 36 to disassemble the diaphragm pump assembly 1.

[0136] return Figure 1 This image illustrates an obstetric vacuum aspirator 10 for assisting vaginal delivery of a fetus. The obstetric vacuum aspirator 10 includes a suction cup 20, a tube 90, and a diaphragm pump assembly 1. The suction cup 20 is configured to be applied to the head of the fetus, and the tube 90 is configured to fluidly connect the diaphragm pump assembly 1 to the suction cup 20. The suction cup 20 includes at least one vacuum chamber 23.

[0137] Tube 90 is a flexible tube 93. The air inlet 34 of the pump chamber 32 is in fluid communication with tube 90 through the air passage 41 in the handheld part 40. The suction cup connector 120 between tube 90 and suction cup 20 is a flexible connector 122, which is configured to provide the operator with more degrees of freedom to apply force 5 in different directions.

[0138] The method of assisting a mother in vaginal delivery using an obstetric vacuum aspirator 10 includes several important steps. The first step is to apply the suction cup 20 to the fetal head. When the suction cup 20 is applied to the fetal head, the operator can begin to create a partial vacuum in the vacuum chamber 23 of the suction cup 20. A vacuum is created in the vacuum chamber 23 of the suction cup 20 by moving the actuation handle 42 from a first position 44 to a second position 45.

[0139] The vacuum level indicator 70 continuously provides information about the vacuum level in the vacuum compartment 23 of the suction cup 20. Once a vacuum is created, the operator can begin applying force 5 to the handle 40 to assist the mother in vaginal delivery. After assisting the mother in vaginal delivery, the vacuum can be released from the vacuum compartment 23 by lifting the release tab 80. Once the vacuum is removed from the vacuum compartment 23, the suction cup 20 can be removed from the fetal head.

[0140] return Figure 3 and Figure 4 The image shows a disassembled obstetric vacuum aspirator 10. The obstetric vacuum aspirator 10 is disassembled during a reprocessing process. This reprocessing process allows for the reuse of the obstetric vacuum aspirator 10. Reuse improves the sustainability of medical devices and can reduce healthcare costs. Each component can be reprocessed after the obstetric vacuum aspirator 10 is disassembled. If it is not disassembled, the device cannot be properly reprocessed. Body fluids between the contact surfaces of the individual components may not be properly removed. Once each component has been reprocessed, the obstetric vacuum aspirator 10 can be reassembled for reuse.

[0141] Each component of the obstetric vacuum aspirator complies with ISO 17665 (moist heat), ISO 18472 (biological and chemical indicators), and ISO 20857 (dry heat) standards, enabling it to withstand sterilization processes and thus allowing for reuse. These ISO standards provide requirements for the development, validation, and routine control of sterilization processes for medical devices.

[0142] Go to Figures 13 to 15 This diagram illustrates an obstetric vacuum connector 100 for connecting a pump assembly 140 to a suction cup 20 of an obstetric vacuum aspirator 10. The connector 100 includes a tube 102. The tube 102 is flexible and configured to fluidly connect the pump 140 to the suction cup 20. The tube 102 has a wall 104 made of an elastic material, particularly silicone rubber. The wall 104 defines an air passage 105 having an air inlet 106 and an air outlet 107. The air inlet 106 is located near a second coupling member 110. The second coupling member 110 is attached to a reinforcement 117 of the tube 102 and is configured to connect the tube to the suction cup 20. Opposite ends 115 of ends 111 are attached to a first coupling member 114. The first coupling member 114 is located near the air outlet 107 and is configured to connect the flexible tube 102 to the pump assembly 140.

[0143] One or more threads 117 extend from the first anchor 116 to the second anchor 112, substantially parallel to the central axis 108 of the air passage 105. The first anchor 116 is part of the first connecting member 114, and the second anchor 112 is part of the second connecting member 110. The one or more threads 117 connected to the anchors 112, 116 enable the connector 100 to withstand forces applied by the operator.

[0144] Go to Figures 16a to 16b Two and three threads 117 are respectively coupled into the wall 104 of the flexible tube 102. The wall 104 may be a tubular wall 124. The threads are configured to resist tension applied to the suction cup 20 via the tube 102. The threads 117 may be completely covered with silicone resin from the wall 104 to prevent any contact between the threads 117 and bodily fluids, thereby simplifying the reprocessing process. Figure 16a and Figure 16b In the case of multiple wires 117 shown, the wires 117 are arranged rotationally symmetrically within the tube wall 104 relative to the central axis 108 of the tube 102, which advantageously distributes the tension evenly around the circumference of the tube 102. Figure 16a In this configuration, wires 117 are arranged in a second-order rotationally symmetrical manner, that is, distributed at a mid-angle of 180 degrees. Figure 16b In the middle, wire 117 is arranged in a 3rd order rotational symmetry manner, that is, distributed at a mid-angle of 120 degrees.

[0145] Go to Figure 18 The image shows a wall 104, in which a wire 117 is attached to the wall 104 of the flexible tube 102. Figure 18 A small deviation from the fully tubular shape of the tubular wall 124 is shown. The wall 104 may also include different shapes, such as squares or triangles. These different shapes can prevent collapse due to the vacuum level achieved in the flexible tube.

[0146] Return to Figure 4 The pump assembly 140 includes a coupling member 142 configured to engage with a first coupling member 114 of the connector 100. The coupling member 142 and the first coupling member 114 can form a bayonet connection that can be easily engaged and disengaged.

[0147] Return to Figure 13 and Figure 15A second connecting member 110 of the tube 102 is connected to the disc body 20 in the central portion 21 of the disc body 20. The connection is centered to allow for even distribution of the force applied by the operator onto the suction cup 20. The second connecting member 110 also includes a circular recess 113 configured to receive the tubular edge 22 of the central portion 21 of the disc body 20. The circular recess 113 and the tubular edge 22 provide a fluid connection between the tube and the suction cup. The circular recess 113 is defined by two flange edges 113a and 113b. The first flange edge 113a is positioned close to the anchor, and the second flange edge 113b is positioned further away from the anchor and closer to the tubular wall 104. The first flange edge 113a is more rigid than the second flange edge 113b to transmit the force applied by the tube to the suction cup 20. The second flange edge 113b is flexible to allow for removal of the suction cup 20 from the flexible tube.

[0148] Figure 17 Another embodiment of the obstetric vacuum connector is shown. In this embodiment, one or more wires are connected differently at the suction cup side end. Wire 117 and a second anchor 112 are attached to the suction cup 20. In this way, it is impossible to remove the flexible tube 102 from the suction cup 20. This improves the reprocessing of the obstetric vacuum connector because it eliminates the need to disassemble the components, saving time.

[0149] The obstetric vacuum connector 100 is manufactured by providing at least one wire 117 in a mold. The wire 117 is then tensioned in the mold. A molded core is disposed in the mold to form an air passage 105 for a tube (not shown). The material for the first and second anchors can be a (thermo)plastic material, which is cast into the mold. After the plastic material of the anchors is cast, silicone resin is cast inside the mold to form the tube. After the silicone has fully cured, the tube can be removed from the mold and the molded core can be removed.

[0150] Go to Figures 19 to 22 ,exist Figure 19 An alternative embodiment of a pump assembly 1 for creating a vacuum during a medical procedure (e.g., for creating a vacuum between the fetal heads) is shown. Figures 20 to 22 The pump assembly 100 is shown excluding the suction cup 20 and the obstetric vacuum connector of the obstetric vacuum aspirator 10. In this embodiment, the pump assembly 1 is a diaphragm pump assembly. The diaphragm pump assembly 1 includes a pump housing 30, a diaphragm 36, an actuation handle 42, and a chamber cover 50. The pump housing 30 is attached to the handle 40. The housing 30 has a cylindrical wall 31 and a bottom at one end. The other end of the housing 30 is open. The diaphragm 36 is arranged at the open end of the housing 30. The chamber cover 50 is arranged on the outer side 39 of the bottom of the housing 30.

[0151] Pump assembly 1 includes a vacuum level indicator 70, which provides information about the vacuum level achieved in suction cup 20. The vacuum level indicator 70 is connected to air passage 41 via an indicator opening 150 in pump housing 30. The vacuum level indicator includes a bellows 154. The bellows 154 is in fluid communication with suction cup 20 via the indicator opening 150. The bellows 154 is configured to expand or compress during use according to the pressure difference between ambient pressure and the vacuum generated within the bellows 154.

[0152] The bellows 154 includes a first bellows end 156 and a second bellows end 158. The second bellows end 158 is configured to connect to a vacuum level indicator connector opening 160 of the chamber cover 50.

[0153] A bellows spring 162 is provided, having two legs that are substantially V-shaped or optionally U-shaped. The bellows spring has a first spring end 164 on one leg and a second spring end 166 on the other leg. The first spring end 164 is configured to connect to a first bellows end 156, and the second spring end 166 is configured to connect to a chamber cover 50 of the pump assembly 1.

[0154] The vacuum level indicator 70 includes a bellows spring 162, which includes a first spring end 164 and a second spring end 166. The first spring end 164 is configured to connect to a first bellows end 156. The second spring end 166 is configured to connect to a chamber cover 50 of the pump assembly 1. The bellows spring 162 is configured to hold the first bellows end 156 relative to the chamber cover 50 in a first bellows position 168 when no vacuum is generated in the bellows 154.

[0155] The first bellows end 156 includes at least one first bellows end connecting element 170. The bellows spring 162 includes a first spring end connector 172, which includes at least one first spring end connector slot 174. The first spring end connector slot 174 is configured to receive at least one first bellows end connecting element 170 for connecting the first spring end 164 to the first bellows end 156. Figures 19 to 22 In this embodiment, a bayonet connection is formed. Those skilled in the art will understand that other types of connections are also possible. The second spring end 166 includes a clamp 176 configured to removably connect the second spring end 166 to the chamber cover 50.

[0156] The vacuum level indicator 70's vacuum pressure gauge 178 correlates the expansion state of the bellows 154 with the vacuum level in the suction cup 20. Figures 19 to 22The vacuum pressure gauge 178 is a simulated vacuum pressure gauge that advantageously shows the continuous change in the vacuum level in the suction cup 20.

[0157] The bellows 154 includes at least one reinforcing ring 180 spaced apart along the centerline 182 of the bellows 154. The at least one reinforcing ring 180 helps to maintain the shape of the bellows 154 and helps to prevent the bellows from expanding in directions other than along the centerline 182 of the bellows 154.

[0158] Alternatively, or in conjunction with at least one reinforcing ring 180, a reinforcing spiral 184 may be used, wherein the centerline 186 of the reinforcing spiral coincides with the centerline 182 of the bellows 154.

[0159] The chamber cover 50 includes a chamber cover connecting member 190 having a protrusion 194. The pump housing 30 includes a corresponding connecting recess 192 on the outer surface 39 of the pump housing 30. The protrusion 194 and the connecting recess 192 are configured to engage with each other to secure the chamber cover 50 to the pump housing 30.

[0160] Go to Figures 23a to 23b , showed Figures 19 to 22 The pump assembly 1 is shown in cross-sectional, front, and side views. In these views, the bellows spring 162 holds the bellows 154 in the first bellows position 168.

[0161] Figures 24a to 24b Depicting and Figures 23a to 23b The same view shown, except that the bellows is in a compressed or deformed state. Figure 24c A vacuum pressure gauge 178 is shown, which includes a mark 196 indicating the vacuum level within a bellows.

[0162] Go to Figures 25a to 25b An alternative embodiment of the obstetric vacuum connector 100 and suction cup 20 is shown. The obstetric vacuum connector 100 and suction cup 20 are integrally connected to each other. This can be achieved by form-fitting and / or chemical bonding. One example of achieving an integral connection is by simultaneously casting the obstetric vacuum connector 100 and suction cup 20.

[0163] Go to Figures 26a to 26b The image shows another side view and cross-sectional view of the obstetric vacuum connector 100 and suction cup 20. Figure 26b The cross-sectional view shows two wires 117 that are incorporated into the wall 104 of the tube 102 of the obstetric vacuum connector 100.

[0164] Figures 27a to 27c It shows Figures 25a to 25bSide view, cross-sectional view, and bottom view of the obstetric vacuum connector 100 and suction cup 20. The vacuum chamber 23 of the suction cup 20 includes an inner disc element 194 located on the wall of the vacuum chamber. The inner disc element 194 is configured to provide equal vacuum pressure throughout the vacuum chamber 23.

[0165] Figures 28a to 28b Different embodiments of an integrally connected obstetric vacuum connector 100 and suction cup 20 are shown, wherein a first connecting member 114 includes at least one protrusion 198 oriented radially outward from the central axis 108 of the flexible tube 102, and wherein the first connecting member 114 is at least partially surrounded by the wall 104 of the flexible tube 102 to form a form fit between the first connecting member 114 and the wall 104 of the flexible tube 102.

[0166] The first connecting component 114 and the wall 104 of the flexible tube 102 can also be integrally connected, especially by chemical bonding.

[0167] Note again that although connector 100 is described as an obstetric vacuum connector used in obstetric vacuum aspirators, it is conceivable that connector 100 can be used for other applications, as mentioned above.

[0168] Figure 29 An embodiment of the pumping assembly 1 is depicted, wherein, in addition to the reinforcing ring 180, the bellows 154 also includes a reinforcing spiral 184. The centerline 186 of the reinforcing spiral 184 coincides with the centerline 182 of the bellows 154.

[0169] Go to Figures 30 to 32 An alternative embodiment of the vacuum level indicator 70 is shown. The vacuum level indicator includes a bellows 154 and a bellows spring 162 integrally connected to the chamber cover 50. A vacuum gauge 178 is also integrally connected to the chamber cover 50.

Claims

1. A pump assembly (1) for generating a vacuum during a medical procedure, such as for generating a vacuum between a fetal head and the suction cup (20) of an obstetric vacuum aspirator (10), the pump assembly comprising: - A pump housing (30) defining a pump chamber (32) and further having an air inlet (34) and an air outlet (35) in fluid communication with the pump chamber. - Pumping component (36), said pumping component being arranged on or within the pump housing and configured to increase or decrease the internal volume of the pump chamber, - A chamber cover (50) is disposed on the outside of the pump housing and covers a portion of the pump housing, wherein the chamber cover includes an inlet valve flap (52) extending above the air inlet, wherein the air inlet and the inlet valve flap constitute a one-way valve (53) configured to allow an inlet airflow (12) to enter the pump chamber as the internal volume of the pump chamber increases.

2. Pump assembly according to the preceding claim, wherein The pump assembly also includes a handheld part (40) attached to or as part of the housing.

3. The pump assembly of any of the preceding claims, further comprising a manually operated actuator (42) movable relative to the pump housing from a first position (44) to a second position (45), or from the second position to the first position, wherein, The manually operated actuator is connected to the pumping component such that when the manually operated actuator moves from the first position to the second position, the internal volume of the pump chamber increases.

4. The pump assembly according to any one of the preceding claims, wherein, The pumping component is a diaphragm.

5. The pump assembly according to claim 4, wherein, The diaphragm is elastic and releasably connected to the pump housing.

6. The pump assembly according to claims 3 and 5, wherein, The manually operated actuator (42) is pivotable about the actuator pivot (46), wherein the manually operated actuator is biased to the first position by the elasticity of the diaphragm.

7. The pump assembly according to any one of claims 4 to 6, further comprising: - A diaphragm connecting member (24), which is positioned in the center (25) of the diaphragm, wherein the diaphragm connecting member is configured to connect with an actuator connecting member (27). - The actuator connecting member is positioned on the upper part (28) of the manually operated actuator.

8. The pump assembly according to any one of claims 3 to 7, wherein, The manually operated actuator can be disconnected from the diaphragm to disassemble the pump assembly.

9. The pump assembly according to any one of the preceding claims, wherein, The chamber cover (50) also includes an outlet valve flap (54) extending above the air outlet, wherein the air outlet and the outlet valve flap constitute a one-way valve (55) configured to allow the outlet airflow (13) to flow out of the pump chamber (32) while reducing the internal volume of the pump chamber (32).

10. The pump assembly according to any one of the preceding claims, wherein, The pump housing also defines an air passage (131) that connects the air inlet to the passage inlet (132).

11. The pump assembly according to any one of the preceding claims, wherein, The pump housing (30) includes a cylindrical wall (31) defining the pump chamber (32).

12. The pump assembly according to any one of the preceding claims, wherein, The pump housing (30) has a slot (37) configured to receive an inlet valve (52) of the chamber cover (50).

13. The pump assembly according to any one of the preceding claims, wherein, The pump housing (30) includes at least one protruding connecting member (38) positioned on the outer surface (39) of the pump housing (30), and the chamber cover (50) has at least one corresponding recess (56), wherein the at least one protruding connecting member (38) and the at least one recess (56) are configured to engage with each other to secure the chamber cover (50) to the pump housing (30).

14. The pump assembly according to any one of the preceding claims, wherein, The pumping component (36) is positioned relative to the chamber cover (50).

15. The pump assembly according to any one of the preceding claims, wherein, The chamber cover (50) includes a channel recess (60), wherein the channel recess (60) and the pump housing (30) define a connection channel (62) that connects the channel inlet (132) to an air passage (41) in fluid communication with the suction cup (20).

16. The pump assembly according to any one of the preceding claims, wherein, The chamber cover (50) includes a vacuum level indicator (70) to provide information about the vacuum level achieved in the suction cup (20).

17. The pump assembly according to the preceding claim, wherein, The branch channel (68) connects the vacuum level indicator (70) to the connection channel (62).

18. The pump assembly according to the preceding claim, wherein, The vacuum level indicator (70) includes at least one deformable member (72) formed in the chamber cover (50), wherein the at least one deformable member (72) extends outward from the outer surface (74) of the chamber cover, and wherein the at least one deformable member (72) is allowed to deform during use by a vacuum generated below the at least one deformable member (72).

19. The pump assembly according to any one of claims 16 to 18, wherein, The vacuum level indicator (70) includes multiple deformable components (72).

20. The pump assembly according to the preceding claim, wherein, Each deformable member (72) deforms at different vacuum levels due to different wall thicknesses, different dimensions, different shapes and / or additional reinforcements.

21. The pump assembly according to any one of the preceding two claims, wherein, Interconnecting channels (69) provide fluid communication between the plurality of deformable members (72).

22. The pump assembly of claim 16, wherein, The indicator opening (150) connects the vacuum level indicator (70) to the air passage (41).

23. The pump assembly of claim 22, wherein, The vacuum level indicator includes: - A bellows (154) in fluid communication with the suction cup through the indicator opening, wherein the bellows is configured to expand or compress during use according to the pressure difference between ambient pressure and a vacuum generated within the bellows, and wherein the bellows comprises: o First bellows end (156), and o Second bellows end (158), the second bellows end being configured to connect to the vacuum level indicator connector opening (160) of the chamber cover, and - A bellows spring (162), wherein the bellows spring includes a first spring end (164) configured to be connected to the first bellows end and a second spring end (166) configured to be connected to the chamber cover of the pump assembly, wherein the bellows spring is configured to hold the first bellows end relative to the chamber cover in the first bellows position (168) when no vacuum is generated in the bellows.

24. The pump assembly of claim 23, wherein: - The first bellows end includes at least one first bellows end connecting element (170), and - The bellows spring includes a first spring end connector (172), wherein the first spring end connector includes at least one first spring end connector slot (174), the at least one first spring end connector slot being configured to receive the at least one first bellows end connecting element (170), the at least one first bellows end connecting element being used to connect the first spring end to the first bellows end.

25. The pump assembly according to any one of claims 22 to 24, wherein, The second spring end includes a clamp (176) configured to removably attach the second spring end to the chamber cover.

26. The pump assembly according to any one of claims 22 to 25, wherein, The vacuum level indicator includes a vacuum gauge (178), particularly an analog vacuum gauge, to correlate the expansion state of the bellows with the vacuum level in the suction cup (20).

27. The pump assembly according to any one of claims 22 to 26, wherein, The bellows includes at least one reinforcing ring (180) spaced apart along the centerline (182) of the bellows.

28. The pump assembly according to any one of claims 22 to 27, wherein, The bellows includes a reinforcing spiral (184), wherein the centerline (186) of the reinforcing spiral coincides with the centerline (182) of the bellows.

29. The pump assembly according to any one of claims 22 to 28, wherein, The chamber cover includes a chamber cover connecting member (190) having a protrusion (194), and the pump housing (30) includes a corresponding connecting recess (192) on the outer surface (39) of the pump housing (30), wherein the protrusion (194) and the connecting recess (56) are configured to engage with each other to secure the chamber cover (50) to the pump housing (30).

30. The pump assembly according to any one of the preceding claims, wherein, The chamber cover includes a release tab (80) configured to at least partially lift the chamber cover (50) from the pump housing 30 to release the vacuum from the connecting channel (62), thereby ultimately releasing the vacuum between the fetal head and the suction cup (20).

31. The pump assembly according to any one of the preceding claims, wherein, The chamber cover is a flexible plate (51) made of elastic material, particularly silicone rubber.

32. The pump assembly according to any one of the preceding claims, wherein, The housing or the handheld part includes a first connecting member (48) configured to connect with a second connecting member (92) of the tube (90).

33. An obstetric vacuum aspirator (10) for assisting a mother in vaginal delivery of a fetus, the obstetric vacuum aspirator comprising: - Pump assembly according to any one of the preceding claims - Suction cup (20), the suction cup being configured to be applied to the fetal head, - A tube (90) for fluidly connecting the pump assembly to the suction cup.

34. The obstetric vacuum aspiration device according to the preceding claim, wherein, The air inlet of the pump chamber (32) is in fluid communication with the pipe (90) through the air passage (41) in the housing or the handheld part.

35. The obstetric vacuum aspiration device according to claim 33 or 34, wherein, The tube (90) is a flexible tube (93).

36. The obstetric vacuum aspiration device according to any one of claims 33 to 35, wherein, The suction cup connector (120) between the tube (90) and the suction cup (20) is a flexible connector (122) which is configured to provide the operator with greater freedom to apply force in different directions (5).

37. The obstetric vacuum aspiration device according to any one of claims 33 to 36, wherein, The suction cup (20) includes at least one vacuum chamber (23).

38. A method for assisting vaginal delivery of a fetus using an obstetric vacuum aspiration device according to any one of claims 33 to 37, the method comprising: - Apply the suction cup (20) to the fetal head, -A vacuum is generated in the vacuum chamber of the suction cup (20). - Apply force to the housing or handle to assist the mother in vaginal delivery. -Release the vacuum from the vacuum compartment of the suction cup (20), - Remove the suction cup (20) from the fetal head.

39. A method for reprocessing the obstetric vacuum aspirator (10) according to any one of claims 33 to 37, wherein, The method includes: -Disassemble the obstetric vacuum aspirator (10), - Clean each component of the obstetric vacuum aspirator (10). - Sterilize each component of the obstetric vacuum aspirator (10). - Reassemble the obstetric vacuum aspirator (10), - Sterilize the obstetric vacuum aspirator (10). Each component of the obstetric vacuum aspirator (10) conforms to ISO 17665, ISO 18472 and ISO 20957 standards to withstand the sterilization process, thereby enabling the obstetric vacuum aspirator (10) to be reused.

40. An obstetric vacuum connector (100) for connecting a pump assembly (140) to a suction cup (20) of an obstetric vacuum aspirator (10), the obstetric vacuum connector (100) comprising: - A flexible tube (102) for fluidly connecting the pump assembly to the suction cup, wherein the tube has a wall (104) defining an air conduit (105) and also has an inlet (106) and an outlet (107). - A first connecting member (114), which is attached to a first side (115) of the flexible tube and configured to connect the flexible tube to the pump assembly. At least one wire (117) is incorporated into the wall, the wire being configured to resist tension applied to the suction cup via the tube.

41. The obstetric vacuum connector according to the preceding claim, wherein, The second connecting component (110) is attached to the second side (111) of the flexible tube (102) and is configured to connect the flexible tube (102) to the suction cup (20).

42. The obstetric vacuum connector according to claim 40 or 41, wherein, The tube (102) is made of an elastic material, particularly silicone rubber.

43. The obstetric vacuum connector according to any one of claims 40 to 42, wherein, The at least one wire (117) is embedded in the wall (104).

44. The obstetric vacuum connector according to any one of claims 40 to 43, wherein, The tube (102) has a central axis (108), and wherein the at least one wire (117) extends substantially parallel to the central axis (108).

45. The obstetric vacuum connector according to any one of claims 40 to 44, wherein, The first connecting component includes a first anchor (116), and the second connecting component includes a second anchor (112), wherein at least one wire is connected to the first anchor (116) and the second anchor (112).

46. ​​The obstetric vacuum connector according to any one of claims 40 to 45, wherein, The at least one wire includes a plurality of wires (117) arranged in the wall in a rotationally symmetrical manner with respect to the central axis of the tube.

47. The obstetric vacuum connector according to any one of claims 40 to 46, wherein, The wall is a tubular wall (124).

48. The obstetric vacuum connector according to any one of claims 40 to 47, wherein, The second anchor (112) is attached to the suction cup (20).

49. The obstetric vacuum connector according to any one of claims 40 to 48, wherein, The first connecting member (114) includes at least one protrusion (198) oriented radially outward from the central axis (108) of the flexible tube (102), and wherein the first connecting member is at least partially surrounded by the wall (104) of the flexible tube (102) to form a shape fit between the first connecting member and the wall of the flexible tube.

50. The obstetric vacuum connector according to any one of claims 40 to 49, wherein, The first connecting component (114) and the flexible tube (102) are integrally connected, particularly by chemical bonding.

51. An obstetric vacuum aspirator (10) for assisting a mother in vaginal delivery of a fetus, the obstetric vacuum aspirator comprising: - Suction cup (20), the suction cup being configured to be applied to the fetal head, - Pump assembly (140) for generating vacuum, - An obstetric vacuum connector (100) according to any one of claims 40 to 50, the obstetric vacuum connector being used to interconnect the suction cup (20) and the pump assembly (140) to provide the suction cup (20) with a vacuum generated by the pump assembly (140).

52. The obstetric vacuum aspiration device according to the preceding claim, wherein, The pump assembly (140) includes a pump assembly coupling component (142) configured to engage with a first coupling component of the obstetric vacuum connector.

53. The obstetric vacuum aspiration device according to claim 51 or 52, wherein, The suction cup has a central opening (21) configured to connect with a second connecting part of the obstetric vacuum aspirator (10), wherein the circular edge (22) of the central opening is configured to be positioned in a tubular recess (113) of the second connecting part.

54. The obstetric vacuum aspiration device according to any one of claims 51 to 53, wherein, The obstetric vacuum connector (100) can be disconnected from the pump assembly to remove the obstetric vacuum aspirator (10).

55. The obstetric vacuum aspiration device according to any one of claims 51 to 54, wherein, The obstetric vacuum connector (100) can be disconnected from the suction cup (20) to disassemble the obstetric vacuum aspirator (10).

56. A method for manufacturing an obstetric vacuum connector, the method comprising: - Provide at least one wire in the mold. - Tension the at least one wire in the mold. - Cast material around a portion of the wire for the first anchor, and cast material around a portion of the wire away from the first anchor for the second anchor. - Cast silicone resin material into the mold such that the wire, at least between the first and second anchors, is embedded in the silicone resin material. - A molding core is provided in the mold to form a tube from the silicone material. - Remove the mold and the molded core.

57. A method for manufacturing an obstetric vacuum connector, the method comprising: - Cast the material for the first and second anchors in the first mold. Remove the first anchor and the second anchor from the first mold, and place the first anchor and the second anchor into the second mold. - At least one wire is provided in the second mold, wherein the at least one wire is connected to the first anchor and the second anchor. - A molding core is provided in the mold to form a tube from cast silicone material. - Tension the at least one wire in the mold. - Cast silicone resin material into the mold, such that the at least one wire is embedded in the silicone resin material. Remove the mold and the molded core.

58. The method according to claim 56 or 57, wherein, The silicone resin material is partially cast around the first anchor and the second anchor.

59. The method according to any one of claims 56 to 58, wherein, The suction cup is cast next to the obstetric vacuum connector, thereby forming an integral connection between the obstetric vacuum connector and the suction cup.

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