Re-usable obstetrical vacuum extractor

Abstract

A pump assembly (1) for developing a vacuum in medical procedures comprises a pump housing defining a pump chamber and furthermore having an air inlet and an air outlet in fluid communication with the pump chamber. A pumping member is arranged on or in the pump housing and configured to increase and decrease an internal volume of the pump chamber. A chamber lid is arranged on an outside of the pump housing and covering a portion of the pump housing, wherein the chamber lid comprises an inlet valve flap extending over the air inlet, wherein the air inlet and the inlet valve flap establish a one- way valve configured to allow an inlet air flow into the pump chamber when the internal volume of the pump chamber is increased.

Description

[0001] Title: Re-usable obstetrical vacuum extractor

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to a re-usable obstetrical vacuum extractor which allows the operator to assist the mother with the delivery of a child. The present invention further relates to a re-usable medical pump assembly for use in such a re-usable obstetrical vacuum extractor, but also to other medical applications.

[0004] BACKGROUND OF THE INVENTION

[0005] In the past 10-15 years there has been a shift towards using vacuum extraction rather than forceps to assist vaginal delivery of a child. Vaginal delivery may be assisted when the second stage of childbirth is not going well. This could be caused by an exhausted mother or when the baby is starting to become distressed. Several variations such as the electrically operated vacuum extractors or disposable vacuum extractors are now used worldwide during vaginal assisted delivery. Electrically operated vacuum extractors are relatively expensive in purchase price and therefore not accessible to everyone. Disposable vacuum extractors require a lower upfront investment, but result in a higher price per use, have a large footprint on the environment and are sometimes used again after delivery to save costs but at the risk of the patient. In this field, various concepts have been proposed.

[0006] WO02088546A1 discloses an obstetrical vacuum extractor and coupled hand-held pump arrangement wherein the pump subassembly includes a diaphragm. The diaphragm is configured to draw a vacuum through an inlet valve to draw a vacuum within the extractor cup. The diaphragm is deflected by moving a handle from a first position to a second position. The handle is biased by plastic springs in the first position. The obstetrical vacuum extractor further comprises a pressure gauge and a relief valve to couple the interior of the cup to the atmosphere.

[0007] A drawback of WO02088546A1 is the complexity of the pump arrangement. It comprises a plurality of separate parts with various channels, interconnections, inaccessible cracks and complex shapes. In addition, it also comprises a pressure gauge. These parts are very difficult, if not impossible, to clean after each usage without rendering the device unusable. Using the device of WO02088546A1 during childbirth will provide body fluids into and onto the device. The device will have to be completely reprocessed before it can be used again to prevent infections. Cleaning issues seem to make it impossible to responsibly re-use the device. Using the device of WO02088546A1 only once has a bad influence on the environment and seems to make usage costly.

[0008] Another example of an obstetric vacuum extractor is disclosed in CN115553897A. The obstetric vacuum extractor of CN115553897A comprises a suction cup, a sleeve assembly and a piston cylinder pump. The piston cylinder pump is operated by a hand-held section comprising a piston rod and a grip handle. The extractor further comprises an electronic system with a display, integrated circuit board and a battery.

[0009] One drawback of the extractor of CN115553897A is its complexity. The electronic system seems to make the device unnecessary, complex and expensive. In addition it also makes it impossible to reprocess each part of the extractor after each use during childbirth. The extractor therefore does not seem to be suitable to be re-used. Resulting in an expensive device with a large footprint on the environment.

[0010] Another drawback of the extractor of CN115553897A is the rigid sleeve assembly between the suction cup and the piston cylinder pump. The position of a foetus during childbirth may vary greatly. The position of a foetus also affects the placement of the suction cup on the head of a foetus and the required direction of the pulling force to support the childbirth. A rigid connection between the suction cup and a pump provides boundaries to the usage of the device and makes it less versatile.

[0011] CN113476121A discloses an obstetric vacuum extractor which comprises a body structure, a display assembly and an absorption assembly. The absorption assembly comprises a suction cup to connect with the head of a foetus and a metal shaped hose. A vacuum is created between the suction cup and the head of a foetus by pressing a rubber balloon. The vacuum level data can be monitored using a display screen. The extractor further comprises a Bluetooth module and a communication module.

[0012] CN113476121A has, for the same reasons, comparable drawbacks as the extractors of WO02088546A1 and CN115553897A. The extractor of CN113476121 A is also complex, expensive and difficult to reprocess. Another drawback of CN113476121A is the ease of use of the extractor. The pumping mechanism is separate from the main body. Two hands are therefore required to create a vacuum while keeping the extractor in the right position. In addition, it also does not comprise a comfortable grip portion to apply a force. The cylinder shaped main body may become slippery due to the body fluids, which may make it challenging to apply the required force for supporting the child birth.

[0013] Another example of an obstetric vacuum extractor is disclosed in WO9958071 A1. The extractor of WO9958071A1 combines a pump and handle into a single hand-held unit. The handle has a surface for gripping and is connected to a vacuum cup. The pump is a piston pump inside the single hand-held unit. Compression of the activation surface of the vacuum pump relative to the handle causes the piston to exhaust fluid through a valve into the atmosphere.

[0014] A drawback of the extractor of WO9958071A1 is that it is designed to be a disposable obstetric vacuum extractor. Being disposable reduces the price per unit, but does not seem to reduce the price per usage. It often even results in a higher price per usage. This creates additional risks in less affluent communities. These communities may be able to afford these extractors but try to use the extractors more than once to cut costs. This may lead to serious health hazards because the extractor of WO9958071A1 is not designed to be reprocessed. In addition, using these extractors only once has a large environmental footprint.

[0015] It is an object of the present invention to overcome at least one of the abovementioned drawbacks and to provide an improved obstetric vacuum extractor to support childbirth.

[0016] After delivery, a mother may suffer from postpartum haemorrhage (PPH), also known as postpartum bleeding. This condition manifests most commonly due to poor contraction of the uterus following childbirth, known as uterine atony. Currently, devices such as uterine balloon tamponades (UBTs) may be used to treat PPH. Drawbacks of such devices are the relatively high costs associated with them, and their use-case being limited to the treatment of PPH.

[0017] It is a further object of the present invention to overcome at least one of the abovementioned drawbacks and to provide a vacuum induced haemorrhage control system to treat postpartum haemorrhage.

[0018] SUMMARY OF THE INVENTION

[0019] At least one of the abovementioned objects is achieved with a pump assembly according to claim 1. One particular aspect of the invention relates to a pump assembly for developing a vacuum between a foetus’s head and a suction cup of an obstetrical vacuum extractor, the pump assembly comprising: a pump housing defining a pump chamber and furthermore having an air inlet and an air outlet in fluid communication with the pump chamber, a pumping member arranged on or in the pump housing and configured to increase and decrease an internal volume of the pump chamber, a chamber lid arranged on an outside of the pump housing and covering a portion of the pump housing, wherein the chamber lid comprises an inlet valve flap extending over the air inlet, wherein the air inlet and the inlet valve flap establish a one-way valve configured to allow an inlet air flow into the pump chamber when the internal volume of the pump chamber is increased.

[0020] The obstetrical vacuum extractor can be used by an operator to assist a mother with vaginal delivery or with caesarean delivery. The invention presents a pump assembly which is able to create a vacuum between the suction cup and the head of a foetus. The internal volume of the pump chamber is small when the pumping member is in a default position. The pumping member seals one side of the pump chamber. The pumping member is moved in a direction opposite to the chamber lid to increase the volume of the pump chamber.

[0021] The pumping member may be configured to move in directions other than a direction opposite to the chamber lid in order to increase the volume of the pump chamber.

[0022] According to Boyle’s law, when a volume increases, the pressure decreases.

[0023] Therefore, a volume with a low air pressure emerges inside the pump chamber. A volume with a higher air pressure is still located in the volume between the suction cup and the head of a foetus. An air flow from the volume with a higher air pressure to the volume with a lower air pressure will emerge. The one-way inlet valve allows the air flow in the direction of the pump chamber. The air flow will continue until an air pressure balance between both volume’s is obtained. Both volume’s will now have a lower air pressure than the ambient air pressure. This will ensure that the suction cup is coupled with the head of a foetus.

[0024] In some of the embodiments, the pump assembly furthermore comprises a hand-held portion attached to or being part of the housing.

[0025] In some of the embodiments, the pump assembly further comprises a manually operated actuator which is movable with respect to the pump housing from a first position to a second position and vice versa, wherein the manually operated actuator is coupled to the pumping member, such that the internal volume of the pump chamber is increased when the manually operated actuator is moved from the first position to the second position.

[0026] In some of the embodiments, the pumping member is a diaphragm.

[0027] In some of the embodiments, the diaphragm is elastic and is releasably connected to the pump housing.

[0028] The diaphragm is elastic to allow increasing and decreasing of the pump chamber volume. Elasticity also forces the manually operated actuator in the default position.

[0029] When connected to the pump housing, the diaphragm and the pump housing form an airtight seal.

[0030] In some of the embodiments, the manually operated actuator is pivotable about an actuator pivot, wherein the manually operated actuator is biased into the first position by the elasticity of the diaphragm.

[0031] The biasing force of the elasticity of the diaphragm together with the shape of the hand-held portion, provides the possibility to handle to pump assembly with a single hand. This is important because an operator often needs the second hand to place the cup on the head of a foetus or to perform other operations.

[0032] In some of the embodiments, the pump assembly further comprising: a diaphragm connection member positioned in a central portion of the diaphragm, wherein the diaphragm connection member is configured to connect with an actuator connection member, the actuator connection member positioned at an upper part of the manually operated actuator,

[0033] In some of the embodiments, the manually operated actuator is disconnectable from the diaphragm to dismantle the pump assembly.

[0034] The manually operated actuator is advantageously disconnectable to be reprocessed easily. In some of the embodiments, the chamber lid furthermore may comprise an outlet valve flap extending over the air outlet, wherein the air outlet and the outlet valve flap establish a one-way valve configured to allow an outlet air flow out of the pump chamber while the internal volume of the pump chamber is decreased.

[0035] The internal volume of the pump chamber decreases again when an operator moves the manually operated actuator from the second position to the first position. Air inside the pump chamber needs to find the way out with the lowest resistance. The one-way inlet valve only allows an air flow into the pump chamber, so the air cannot flow back to the suction cup. The one-way outlet valve does allow an air flow out of the pump chamber and into the environment.

[0036] By having the chamber lid establish a one-way valve to allow an outlet air flow as well as a one-way valve to allow an inlet air flow, the obstetrical vacuum extractor requires fewer separate components. Fewer components decrease the complexity of the system. The obstetrical vacuum extractor can advantageously be disassembled for reprocessing to allow re-usage of the obstetrical vacuum extractor. Disassembling fewer components saves time, makes it more manageable and reduces the risk of losing or misplacing components.

[0037] It is possible to configure the inlet and outlet valve flaps to act in reverse. This may be achieve by placing them on the opposite end of the air inlet and air outlet. In such embodiments, the pump assembly will develop an overpressure instead of a vacuum. This may be beneficial in certain medical procedures.

[0038] The foregoing feature of the chamber lid comprising an outlet valve flap extending over the air outlet may also be employed in other embodiments of the chamber lid separately from the other features of the chamber lid. Thus, for example, according to another aspect of the invention, there is provided a pump assembly for developing a vacuum, for example between a foetus’s head and a suction cup of an obstetrical vacuum extractor, the pump assembly comprising: a pump housing defining a pump chamber and furthermore having an air inlet and an air outlet in fluid communication with the pump chamber, a pumping member arranged on or in the pump housing and configured to increase and decrease an internal volume of the pump chamber, a chamber lid arranged on an outside of the pump housing and covering a portion of the pump housing, wherein the chamber lid furthermore comprises an outlet valve flap extending over the air outlet, wherein the air outlet and the outlet valve flap establish a one-way valve configured to allow an outlet air flow out of the pump chamber while the internal volume of the pump chamber is decreased.

[0039] In some of the embodiments, the pump housing further defines an air channel which connects the air inlet with a channel inlet.

[0040] In some of the embodiments, the pump housing comprises a cylindrical wall defining the pump chamber.

[0041] In some of the embodiments, the pump housing has a slot configured to receive the inlet flap valve of the chamber lid.

[0042] The inlet flap extends from the inner surface of the chamber lid. The extending inlet flap enters the pump chamber through the slot and covers the chamber inlet. The valve is bendable in a direction inwards to the pump chamber by an air flow. Therefore, the air flow from the suction cup to the chamber, forces the inlet flap slightly away from the cylindrical wall to allow the air flow into the chamber. An opposite air flow is not possible due to the position of the flap. An airflow in the direction of the inlet flap causes the inlet flap to create an air tight connection with the cylindrical wall, forcing the air to find another way out of the pumping chamber.

[0043] By having a slot configured to receive the inlet flap valve of the chamber lid, it becomes possible to achieve lower vacuum levels. The position of the one-way valve close to the pump chamber removes the potential space for dead volume in the pump assembly. The dead volume prevents that the air trapped in the pump chamber can be completely expelled into the environment.

[0044] In some of the embodiments, the pump housing comprises at least one protruding connection member positioned on an outer surface of the pump housing and the chamber lid has at least one corresponding recess, wherein said at least one protruding connection member and said at least one recess are configured to couple with each other to fix the chamber lid to the pump housing. This could also be the other way around, i.e. the pump housing having a recess and the chamber lid having a corresponding protruding connection member. The at least one protruding connection member and corresponding recess provide easy coupling between the chamber lid and the pump housing.

[0045] In some of the embodiments, the pumping member is positioned opposite to the chamber lid.

[0046] In some of the embodiments, the chamber lid comprises a channel recess, the channel recess and the pump housing define a connection channel which connects the channel inlet to an air passage which is in fluid communication with the suction cup.

[0047] By having a connection channel defined by a channel recess and the pump housing it becomes better accessible. The chamber lid can be removed from the pump housing. Once removed it is easy to clean the surface of the pump chamber and channel recess which defined the connection channel. Both are visible and can be cleaned with different cleaning purposes. This is easier compared to an internal channel in one of the components which may be difficult the access and is not very visible.

[0048] In some of the embodiments, the chamber lid comprises a vacuum level indicator to provide information about the reached vacuum level in the suction cup.

[0049] An operator of the obstetrical vacuum extractor needs to be able to monitor the vacuum level obtained between the head of a foetus and the suction cup. The suction cup might damage the vulnerable head and / or skin of a foetus when the obtained vacuum level exceeds a certain limit. On the other side, when the obtained vacuum level is not sufficient, the suction cup might be disconnected from the head of a foetus when the required force is applied by the operator. Undesirable disconnection of the suction cup from the heat of a foetus may occur a maximum of three times before an operator has to proceed with a caesarean section. Disconnection might also damage the head of a foetus.

[0050] The foregoing feature of the chamber lid comprising a vacuum level indicator may also be employed in other embodiments of the chamber lid separate from the other features of the chamber lid. Thus, for example, according to another aspect of the invention, there is provided a pump assembly for developing a vacuum between a foetus’s head and a suction cup of an obstetrical vacuum extractor, the pump assembly comprising: a pump housing defining a pump chamber and furthermore having an air inlet and an air outlet in fluid communication with the pump chamber, a pumping member arranged on or in the pump housing and configured to increase and decrease an internal volume of the pump chamber, a chamber lid arranged on an outside of the pump housing and covering a portion of the pump housing, wherein the chamber lid comprises a vacuum level indicator to provide information about the reached vacuum level in the suction cup.

[0051] In some of the embodiments, a branch channel connects the vacuum level indicator to the connection channel.

[0052] The branch channel may be, just as the connection channel, defined by the chamber lid and the pump housing. Therefore, the advantages of the connection channel also apply to the branch channel. These advantages are not repeated for the sake of brevity. The branch channel further provides a direct fluid communication between the suction cup and the vacuum level indicator.

[0053] In some of the embodiments, the vacuum level indicator comprises at least one deforming member formed in the chamber lid, wherein the at least one deforming member extends outwardly from an outer surface of the chamber lid, and wherein the at least one deforming member during use is allowed to deform by a certain level of vacuum developed below the at least one deforming member.

[0054] Using an integrated deforming member in the chamber lid adds another functionality to the chamber lid. In this way, the number of separate components is further reduced. In addition, a deforming member also provides a very basic implementation of a vacuum level indicator compared to e.g. a pressure gauge. This further reduces the complexity of the obstetrical vacuum extractor.

[0055] In some of the embodiments, the vacuum level indicator comprises a plurality of deforming members.

[0056] In some of the embodiments, each deforming member deforms at different vacuum levels due to varying wall thicknesses, varying sizes, varying shapes and / or additional reinforcements.

[0057] The plurality of deforming members may be combined with visible markers like a colormap or visible numbers to assign a certain obtained vacuum level with the deforming of one or more of the plurality of deforming members. This provides a clear and simple overview for the operator.

[0058] In some of the embodiments, the deforming members may be domes.

[0059] In some of the embodiments, an interconnection channel provides fluid communication between the plurality of deforming members.

[0060] In some embodiments, an indicator opening connects the vacuum level indicator to an air passage.

[0061] In some embodiments, the vacuum level indicator comprises: a bellows which is in fluid communication with the suction cup through the indicator opening, wherein the bellows is configured to, during use, expand or compress according to a pressure differential between the ambient pressure and a vacuum developed within the bellows, and wherein the bellows comprises: o a first bellows end, and o a second bellows end configured to be connected to a vacuum level indicator connector opening of the chamber lid, and a bellows spring, wherein the bellows spring comprises a first spring end configured to be connected with the first bellows end and a second spring end configured to be connected with the chamber lid of the pump assembly, wherein the bellows spring is configured to hold the first bellows end in a first bellows position relative to the chamber lid when no vacuum is developed in the bellows.

[0062] The bellows may be combined with an index comprised of visible markers like a colormap or visible numbers to assign a certain obtained vacuum level with the deformation of the bellows. This provides a clear and simple overview for the operator.

[0063] The bellows and bellows spring may be integrally connected. This provides the benefit of a reduced number of parts, easing assembly and disassembly for the purposes of e.g. sterilisation by an operator.

[0064] The vacuum level indicator comprising the bellows and the bellows spring, the inlet valve, the outlet valve and the chamber lid may be integrally connected so as to form one part. In some embodiments, the first bellows end comprises at least one first bellows end connection element, and the bellows spring comprises a first spring end connector, wherein the first spring end connector comprises at least one first spring end connector slot configured to receive the at least one first bellows end connection element for connecting the first spring end with the first bellows end.

[0065] The first bellows end connection element and the first spring end connector may form a bayonet coupling. Other types of connectors are possible as well, such as snap-fit connectors, threaded connectors, luer lock connectors or magnetic connectors.

[0066] In some embodiments, the second spring end comprises a clamp configured to removably connect the second spring end to the chamber lid.

[0067] In some embodiments, the vacuum level indicator comprises a vacuum pressure gauge, in particular an analogue vacuum pressure gauge, to relate the deformation of the bellows to a vacuum level in the suction cup.

[0068] The spring force delivered 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 pressure gauge which corresponds to the vacuum level developed within the bellows.

[0069] In some embodiments, the bellows comprise at least one reinforcement ring spaced along a centre line of the bellows.

[0070] In some embodiments, the bellows comprise a reinforcement helix, wherein a centre line of the reinforcement helix coincides with a centre line of the bellows.

[0071] In some embodiments, the chamber lid comprises a chamber lid connection member having a protrusion and the pump housing comprises a corresponding connection recess on an outer surface of the pump housing, wherein said protrusion and said connection recess are configured to couple with each other to fix the chamber lid to the pump housing. This could also be the other way around, i.e. the chamber lid having a connection recess and the housing a corresponding protrusion.

[0072] In some of the embodiments, the chamber lid comprises a relief tab configured to lift the chamber lid at least partially from the pump housing to relieve the vacuum from the connection channel and thereby eventually between the head of a foetus and the suction cup. This again adds another functionality to the chamber lid. The relief tab provides a simple solution in relieving the vacuum. An operator can use a single hand to lift the relief tab. This also omits the need for a separate controllable relief valve, which might be difficult to clean and makes the obstetrical vacuum extractor unnecessary complex.

[0073] In some of the embodiments, the chamber lid is a flexible plate made of an elastic material, in particular of silicone rubber.

[0074] In some embodiments, the chamber lid may comprise a relief plug configured to relieve the vacuum in the suction cup. The plug formed on the chamber lid may be received in a relief opening in the housing. When the plug is pulled from the opening the vacuum is relieved.

[0075] In some of the embodiments, the housing or the hand-held portion comprises a first coupling member configured to couple with a second coupling member of a tube.

[0076] The invention further relates to an obstetrical vacuum extractor to assist a mother with the vaginal delivery of a foetus, the obstetrical vacuum extractor comprising:

[0077] - the pump assembly according to the present invention,

[0078] - a suction cup configured to be applied to the head of a foetus,

[0079] - a tube to fluidly connect the diaphragm pump assembly to the suction cup.

[0080] In some of the embodiments, the air inlet of the pump chamber is in fluid communication with the tube by an air passage in the housing or the hand-held portion.

[0081] The position of the first coupling member is important because an operator should be able to exert a force on the suction cup and tube with a single hand. The air passage provides freedom of design, whereby the optimal position of the first coupling member can be chosen in view of its intended use.

[0082] In some of the embodiments, the tube is a flexible tube.

[0083] In some of the embodiments, a suction cup coupling between the tube and the suction cup is a flexible coupling configured to provide more freedom for the operator to apply a force in different directions.

[0084] A flexible tube and flexible coupling provide complete freedom to exert a force on the suction cup and head of a foetus in different directions. The position of the head of a foetus differs strongly and different positions require different directions in which the head of a foetus should be displaced to support childbirth.

[0085] In some of the embodiments, the suction cup comprises at least one vacuum compartment.

[0086] In some embodiments, the suction cup may comprise inner cup elements on the vacuum compartment wall configured to provide equal vacuum pressure throughout the vacuum compartment.

[0087] When a vacuum is created an object, such as a the head of a foetus, may fully or partially block the air inlet of an obstetrical vacuum connector. As a result, subsequent vacuum pressure generated by a pump assembly will only or mostly act on the portion of the object fully or partially blocking the air inlet of the obstetrical vacuum connector. The inner cup elements allow for airflow from the vacuum compartment of the suction cup to the air inlet even if an object is positioned at or near the air inlet, creating equal vacuum pressure throughout the vacuum compartment. Equal vacuum pressure leads to more even grip on the object.

[0088] Another aspect of the invention relates to a method for assisting a mother with the delivery of a foetus making use of an obstetrical vacuum extractor as is described in the foregoing, wherein the method comprises: applying the suction cup to the head of the foetus, developing a vacuum in the vacuum compartment of the suction cup, applying a force to the housing or hand-held portion to assist the mother with the delivery, releasing the vacuum from the vacuum compartment of the suction cup, removing the suction cup from the head of the foetus.

[0089] The method provides the same advantages as the device.

[0090] Another aspect of the invention relates to a method for reprocessing the obstetrical vacuum extractor as is described in the foregoing, wherein the method comprises: disassembling the obstetric vacuum extractor, cleaning each part of the obstetric vacuum extractor, disinfecting each part of the obstetric vacuum extractor, reassembling the obstetric vacuum extractor, sterilising the obstetric vacuum extractor, wherein each part of the obstetrical vacuum extractor complies with the ISO 17665, ISO 18472 and ISO 20957 standards to be able to withstand the sterilising process to allow the re-usage of the obstetric vacuum extractor.

[0091] Re-usability of the obstetrical vacuum extractor greatly improves the sustainability of the device. It also makes it possible to increase the price for a device, while the price for a single usage decreases. Making it affordable for a larger amount of people.

[0092] The invention further relates to an obstetrical vacuum connector for connecting a pump assembly with a suction cup of an obstetrical vacuum extractor, the obstetrical vacuum connector comprising: a flexible tube to fluidly connect the pump assembly to the suction cup, wherein the tube has a wall, the wall defining an air duct and furthermore having an inlet and an outlet, a first coupling part attached to a first side of the flexible tube and configured to couple the flexible tube to the pump assembly, wherein at least one wire is incorporated in the wall, which wire is configured to resist a tensional force applied to the suction cup via the tube.

[0093] By having a wire incorporated into the wall of the flexible tube, the wall does not have to be rigid to withstand the forces exerted on the suction cup. Incorporating into the wall also ensures that none of the body fluids contacts the wire. This makes it easier to clean the obstetrical vacuum extractor.

[0094] In some of the embodiments, a second coupling part is attached to a second side of the flexible tube and is configured to couple the flexible tube to the suction cup.

[0095] In some of the embodiments, the tube is made of an elastic material, in particular of silicone rubber.

[0096] In some of the embodiments, the at least one wire is embedded in the wall.

[0097] In some embodiments, the at least one wire may be made of an aromatic polyamide, otherwise known as para-aramids, such as Kevlar® or Twaron®. In some of the embodiments, the tube has a central axis and the at least one wire extends substantially parallel to said central axis.

[0098] The wire being substantially parallel to the central axis of the tube prevents that the flexible tube obtains a tendency to curl together when no tension is applied to the flexible tube.

[0099] In some of the embodiments, the first coupling part comprises a first anchor and the second coupling part comprises a second anchor, and wherein at least one wire is connected to the first anchor and the second anchor.

[0100] In some of the embodiments, the at least one wire comprises a plurality of wires, which are arranged rotationally symmetric in the wall with respect to the central axis of the tube.

[0101] The plurality of wires are arranged rotationally symmetric to equally divide the force exerted on the flexible tube. This provides better control for the operator.

[0102] In some of the embodiments, the wall is a tubular wall.

[0103] In some of the embodiments, the second anchor is incorporated into the suction cup.

[0104] It is to be noted that it is envisaged that a connector a described in the foregoing can also be used in other applications than for obstetrical vacuum extractors, in particular also in medical applications wherein a medium has to be transported from one location to another through the tube and wherein a tensional force has to be applied to the tube wall.

[0105] The present invention further relates to an obstetrical vacuum extractor to assist a mother with the vaginal delivery of a foetus, the obstetrical vacuum extractor comprising:

[0106] - a suction cup configured to be applied to the head of a foetus,

[0107] - a pump assembly for developing a vacuum,

[0108] - the obstetrical vacuum connector as described in the foregoing for interconnecting the suction cup and the pump assembly so as to provide the vacuum developed by the pump assembly to the suction cup.

[0109] In some of the embodiments, pump assembly comprises a pump assembly coupling part configured to couple with the first coupling part of the obstetrical vacuum connector. In some of the embodiments, the suction cup has a central opening configured to couple with the second coupling part of the obstetrical vacuum extractor, wherein a circular edge of the central opening is configured to be positioned in a tubular recess of the second coupling part.

[0110] In this way, it becomes possible to easily connect and disconnect the flexible tube from the suction cup, while at the same time being able to provide an airtight connection between the suction cup and the flexible tube.

[0111] In some of the embodiments, the obstetrical vacuum connector is disconnectable from the pump assembly to dismantle the obstetrical vacuum extractor.

[0112] In some of the embodiments, the obstetrical vacuum connector is disconnectable from the suction cup to dismantle the obstetrical vacuum extractor.

[0113] Another aspect of the invention relates to a method for manufacturing an obstetrical vacuum connector, the method comprising: providing at least one wire in a mould, tensioning the at least one wire in the mould, casting the material for a first anchor around a portion of the wire and a second anchor around a portion of the wire remote from the first anchor, casting a silicone material inside the mould such that the wire at least between the first and second anchor is embedded in the silicone material, providing a moulding core in the mould to form a tube from the silicone material, removing the mould and moulding core.

[0114] Another aspect of the invention relates to a method for manufacturing an obstetrical vacuum connector, the method comprising: casting material for a first anchor and a second anchor in a first mould, removing the first anchor and second anchor from the first mould and placing the first anchor and second anchor in a second mould, providing at least one wire in the second mould, wherein the at least one wire is connected to the first and second anchor, providing a moulding core in the mould to form a tube from cast silicone material, tensioning the at least one wire in the mould, casting a silicone material inside the mould such that the at least one wire is embedded in the silicone material, removing the mould and moulding core.

[0115] The two methods described above provide the same advantages as the device.

[0116] In an embodiment of the methods, the silicone material is cast partially around the first and second anchor.

[0117] In an embodiment of the methods, a suction cup is cast alongside the obstetrical vacuum connector, forming an integral connection between the obstetrical vacuum connector and the suction cup.

[0118] In some of the embodiments, a vacuum may be developed in the vacuum compartment of the suction cup by the pump assembly by moving the manually operated actuator from the first position to the second position.

[0119] In some embodiments, the medical procedure may include developing a vacuum between a foetus’s head and a suction cup of an obstetrical vacuum extractor.

[0120] According to another aspect the pump assembly is usable in other medical applications which require vacuum pumping action, i.e. other than for developing a vacuum between a foetus’s head and a suction cup of an obstetrical vacuum extractor. The other medical application may be both within the subfield of obstetrics and outside of it. The pump assembly may, for instance, be used for vacuum-induced haemorrhage control to treat postpartum haemorrhage (PPH), a potentially life-threatening condition.

[0121] The medical procedure may include treating postpartum haemorrhage, in particular through vacuum-induced haemorrhage control.

[0122] Also other applications for the pump assembly are conceivable, for example in suction devices to remove body fluids, e.g. blood, wound fluid, etc.

[0123] The invention will be further elucidated in the following detailed description with reference to the drawings.

[0124] BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 shows an isometric view of the obstetrical vacuum extractor according to the invention;

[0125] Figures 2 and 3 show isometric views of a disassembled obstetrical vacuum extractor;

[0126] Figure 4 shows a side view of a disassembled obstetrical vacuum extractor;

[0127] Figures 5a - 5d show a cross-sectional, side view of the obstetrical vacuum extractor;

[0128] Figures 6a - 6b show an isometric view of the obstetrical vacuum extractor;

[0129] Figure 7 shows an isometric, top view of the chamber lid;

[0130] Figure 8 shows an isometric, bottom view of the chamber lid;

[0131] Figure 9a shows a top elevational view of the chamber lid and vacuum level indicator;

[0132] Figure 9b shows a bottom elevational view of the chamber lid and vacuum level indicator;

[0133] Figure 10 shows a cross section of a part of the obstetrical vacuum extractor of Figure 1 without a chamber lid and diaphragm;

[0134] Figure 11 shows the cross section of a part of the obstetrical vacuum extractor of Figure 10, but with the chamber lid and diaphragm;

[0135] Figure 12 shows another cross section of a part of the obstetrical vacuum extractor of

[0136] Figure 10, but with the chamber lid and diaphragm;

[0137] Figure 13 shows an isometric view of the obstetrical vacuum connector;

[0138] Figure 14 shows a side elevational view of the obstetrical vacuum connector;

[0139] Figure 15 shows a cross-sectional, side view of the obstetrical vacuum connector;

[0140] Figures 16a - 16b, show a cross-sectional view of the flexible tube;

[0141] Figure 17 shows a cross-sectional view of another obstetrical vacuum connector;

[0142] Figure 18 shows a cross-sectional view of the flexible tube;

[0143] Figure 19 shows an isometric view of a different embodiment of the pump assembly;

[0144] Figure 20 shows an isometric view of an obstetrical vacuum extractor comprising different embodiments of the pump assembly, and obstetrical vacuum connector and suction cup;

[0145] Figure 21 shows an isometric view of the disassembled obstetrical vacuum extractor of Figure 20;

[0146] Figure 22 shows a side view of the disassembled obstetrical vacuum extractor of Figure 20;

[0147] Figures 23a - 23b show a cross-sectional side view, a front view and a side view of an alternative embodiment of the pump assembly;

[0148] Figures 24a - 24b show the respective pump assembly in figures 23a - 23b with the bellows of the pump assembly in a compressed or deformed position;

[0149] Figures 25a - 25b show a side view and a cross-sectional view of an obstetrical vacuum connector and a suction cup which are integrally connected; Figures 26a - 26b show the integrally connected obstetrical vacuum connector and suction cup of Figures 25a - 25b in a different side view and cross-sectional view; Figures 27a - 27c show the integrally connected obstetrical vacuum connector and suction cup of Figures 25a - 25b in a side view, a cross-sectional view of the tube of the obstetrical vacuum connector and a bottom view of the suction cup;

[0150] Figures 28a - 28b show a side view and a cross-sectional view of an embodiment of the obstetrical vacuum connector and suction cup;

[0151] Figure 29 shows an alternative embodiment of the pumping assembly having a reinforcement helix;

[0152] Figures 30 - 31 show an alternative embodiment of the vacuum level indicator of an obstetrical vacuum extractor, wherein the bellows, bellows spring and chamber lid are integrally connected.

[0153] DETAILED DESCRIPTION

[0154] One aspect of the invention disclosed herein relates to a pump assembly for developing a vacuum in medical procedures, wherein the pump assembly comprises a pump housing defining a pump chamber and furthermore has an air inlet and an air outlet in fluid communication with the pump chamber. The pump assembly furthermore comprises a pumping member arranged on or in the pump housing and configured to increase and decrease an internal volume of the pump chamber. Furthermore, the pump assembly comprises a chamber lid arranged on an outside of the pump housing and covering a portion of the pump housing, wherein the chamber lid comprises an inlet valve flap extending over the air inlet, wherein the air inlet and the inlet valve flap establish a one-way valve configured to allow an inlet air flow into the pump chamber when the internal volume of the pump chamber is increased.

[0155] Turning to figures 1-4, one specific embodiment of such a pump assembly 1 for developing a vacuum between a foetus’s head and a suction cup 20 of an obstetrical vacuum extractor 10 is shown. The pump assembly 1 in this embodiment is a diaphragm pump assembly. The diaphragm pump assembly 1 comprises a pump housing 30, a diaphragm 36 an actuating handle 42 and a chamber lid 50. The pump housing 30 is attached to a handheld portion 40. The housing 30 has a cylindrical wall 31 and a bottom at one end thereof. The other end of the housing 30 is open. A diaphragm 36 is arranged on the housing 30 at the open end thereof. The chamber lid 50 is arranged on an outer side 39 of the bottom of the housing 30. It is noted that in this detailed description the invention is illustrated with reference to a diaphragm pump assembly. However, also other pump types having another pumping member than a diaphragm, such as for example a piston, are envisaged to cooperate with the other components of the pump assembly described herein.

[0156] The hand-held portion 40 comprises a first coupling member 48 configured to couple with a second coupling member 92 of a tube 90. The first and second coupling members may form a bayonet coupling, but may also form different couplings. The coupling allows simple coupling and de-coupling of the parts. It also allows coupling of the tube 90 with the bottom of the suction cup pointed to different directions.

[0157] Turning to figures 5a - 5c, a cross-sectional view of the diaphragm pump assembly 1 is shown. In figures 10-12 further cross sectional views are shown. The pump housing 30 defines a pump chamber 32. The pump housing 30 further has an air inlet 34 and an air outlet 35. The air inlet 34 and air outlet 35 are in fluid communication with the pump chamber 32. The diaphragm 36 is elastic and is releasably connected to the cylindrical wall 31 of the housing 30. The edges of the diaphragm 36 couple with the edge of the cylindrical wall 31. The edge of the cylindrical wall has a protruding circumferential rim 31 A (cf. Fig. 10) which cooperates with the diaphragm 36 to attach the diaphragm 36 to the wall 31 of the housing 30. The diaphragm 36 arranged on the pump housing 30 is configured to increase and decrease an internal volume of the pump chamber 32. The actuating handle 42 is coupled to the diaphragm 36, such that the diaphragm 36 moves with the actuating handle 42. By the resulting deformation of the diaphragm 36, the internal volume of the pump chamber 32 is increased when the actuating handle 42 is moved from the first position 44 to the second position 45. The handle 40 further comprises hollow internal sections 43. These internal sections 43 reduce the overall weight of the assembly 1.

[0158] The internal volume of the pump chamber is increased and decreased by moving the actuating handle 42 with respect to the pump housing 30 from a first position 44 to a second position 45 and vice versa. The actuating handle 42 is pivotable about a handle pivot 46 and the actuating handle is biased into the first position by the elasticity of the diaphragm. The biasing force of the elasticity of the diaphragm may be further enhanced by a spring in the hand-held portion. Both the actuating handle 42 and the base part of the hand-held portion 40 have similar shapes. Together they comprise the shape of a pliers and are therefore very suitable to be handled and pinched by the operator single-handedly. This is further facilitated by the biasing force of the elasticity of the diaphragm. The diaphragm 36 is arranged on one end of the pump housing. On the opposite end of the pump housing 30 a bottom 33 is formed. A chamber lid 50 is arranged on the outside of the bottom 33 of the pump housing 30. The chamber lid 50 comprises an inlet valve flap 52 which is upstanding with respect to the main body of the chamber lid 50. The valve flap extends along an inner side of the wall 31 and is lying over the air inlet 34. The inner side of the wall is provided with a recessed valve seat zone 31 B to receive the valve flap 52. The air inlet 34 and the inlet valve flap 52 establish a one-way valve 53 configured to allow an inlet air flow 12 (illustrated by a dashed arrow in Fig.11) into the pump chamber 32 during a suction stroke, i.e. when the actuation handle 42 is moving from the first position to the second position. The pump housing 40 has a slot 37 in the bottom 33 configured to insert the inlet flap valve 52 through, such that the flap 52 extends into the chamber 32.

[0159] In figures 5a and 5b, the diaphragm pump assembly 1 is shown with and without the chamber lid 50. The chamber lid 50 comprises an outlet valve flap 54 extending over the air outlet 35. The air outlet 35 and the outlet valve flap 54 establish a one-way valve 55 configured to allow an outlet air flow 13 (illustrated by a dashed arrow in Fig. 5d) out of the pump chamber 32 while the actuation handle 42 is moving from the second position 45 to the first position 44.

[0160] Figure 5b shows the actuating handle 42 in the first position 44. Figure 5c shows the actuating handle 42 in the second position 45, resulting in a maximum volume of the pump chamber 32. The increment in volume of the chamber initiates an air flow into the chamber. The one-way outlet valve 54 prevents an air flow from the environment into the chamber. The underpressure in the valve chamber 32 resulting from the increasing chamber volume, results in that the valve flap 52 moves away from the valve seat 31 B and allows that air coming from the suction cup is sucked in the chamber via the air inlet 34. Air will flow from the relatively high air pressure volume inside the suction cup to the low-pressure volume in the pump chamber, reducing the air pressure in the suction cup. Repeating the pumping step creates a partial vacuum between the suction cup and the head of a foetus. When the actuation handle 42 is moving from the second position 45 to the first position 44, the chamber volume decreases whereby the pressure in the chamber 32 increases. This increased pressure pushes the valve flap 52 against the seat 31 B and thereby closes the air inlet 34. The increased pressure will eventually become high enough to push the outlet valve flap 54 away from its seat and allow air to escape from the pump chamber 32 through the air outlet 35.

[0161] The pump housing defines an air channel 131 which connects the air inlet 34 with a channel inlet 132, as is shown in figures 10 and 12. Returning to figures 3 and 4, the pump housing 30 comprises at least one protruding member 38 positioned on an outer surface 39 of the bottom 33 of the pump housing 30. The outer surface 39 of the housing 30 is positioned on one end of the cylindrical wall. The chamber lid 50 has at least one corresponding recess 56. The at least one protruding connection member 38 and said at least one recess 56 are configured to couple with each other to fix the chamber lid 50 to the pump housing 30. The housing 30 may also comprise multiple protruding members 38 divided over the surface of the housing 30. The lid 50 of the housing 30 comprises an equal number of recesses, each one of them corresponds to a protruding member of the outer surface. One or more connection points ensure that the lid 50 remains in the correct position during the entire operation.

[0162] Turning to figures 7 - 9b, the chamber lid 50 is shown separately. The chamber lid 50 comprises a channel recess 60. The channel recess 60 and the pump housing 30 define a connection channel 62 which 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 lid 50 further comprises a vacuum level indicator 70 to provide information about the reached vacuum level 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 through the channel 132 and the one-way inlet valve. It is directly connected to the suction cup through the air passage 41 and the hose 90 to provide direct information of the obtained vacuum between the suction cup 20 and the head of a foetus.

[0163] The vacuum level indicator 70 comprises at least one deforming member 72 formed in the chamber lid 50. The at least one deforming member 72 extends outwardly from an outer surface 74 of the chamber lid 50. The at least one deforming member 72 is during use allowed to deform by a vacuum developed below the at least one deforming member 72. The vacuum level indicator 70 further may comprise a plurality of deforming members 72. The deforming members 72 could be domes or any other shape such as triangles or squares. The deforming members 72 each have a different wall thickness so as to be deformed at different vacuum levels. Deforming at different vacuum levels may also be achieved with a constant wall thickness with different deforming member sizes, shapes and / or adding additional support such as ribs. An interconnection channel 69 provides fluid communication between the plurality of deforming members 72.

[0164] The thickness, size and shape of the wall of a deforming member represents a certain elasticity. The decreasing air pressure inside the deforming members decreases the force exerted from the inside to each deforming member, while the force to the outside of the deforming member from the ambient pressure remains constant. When the air pressure below the deforming member reaches a certain bottom limit, the deforming member will deform due to the force of the ambient pressure.

[0165] Turning to figures 6a - 6b, the operational principle of the chamber lid 50 is shown. The chamber lid 50 is a flexible plate 51 made of an elastic or flexible material, in particular of silicone rubber. The lid may have a corresponding shape with the surface 39 of the housing 30, but may also have a different shape.

[0166] Figure 6a shows the vacuum level indicator 70 with four deforming members 72 of which two are deformed members 73. The deformed members 73 provide an operator of the obstetrical vacuum extractor 10 with information about the reached vacuum level between the head of a foetus and the suction cup 20. The chamber lid may further comprise a relief tab 80. Only the relief tab extends from the housing when the lid 50 is positioned on the outer surface 39 of the housing 30. The relief tab 80 is configured to lift the chamber lid 50 at least partially from the pump housing 30 to relieve the vacuum from the connection channel 62 and thereby eventually between the head of a foetus and the suction cup 20. Lifting the tab 80 from the housing 30 bends the flexible plate 51. The air pressure balance is automatically restored when one of the channels in the chamber lid 50 are exposed to the environment.

[0167] Returning to figure 5a, a diaphragm connection member 24 positioned in a central portion 25 of the diaphragm 36 is shown. The diaphragm connection member 24 comprises a hook 26 which is configured to connect with an actuating handle connection member 27. The actuating handle connection member 27 is positioned at an upper part 28 of the actuating handle 42. The actuating handle connection member 27 comprises a connection bar 29 configured to be grabbed by the hook 26. The actuating handle 42 is disconnectable from the diaphragm 36 to dismantle the diaphragm pump assembly 1.

[0168] Returning to figure 1, an obstetrical vacuum extractor 10 to assist a mother with the vaginal delivery of a foetus is shown. The obstetrical vacuum extractor 10 comprises a suction cup 20, a tube 90 and the diaphragm pump assembly 1. The suction cup 20 is configured to be applied to the head of a foetus and the tube 90 is configured to fluidly connect the diaphragm pump assembly 1 to the suction cup 20. The suction cup 20 comprises at least one vacuum compartment 23.

[0169] The tube 90 is a flexible tube 93. The air inlet 34 of the pump chamber 32 is in fluid communication with the tube 90 by an air passage 41 in the hand-held portion 40. A suction cup coupling 120 between the tube 90 and the suction cup 20 is a flexible coupling 122 configured to provide more freedom for the operator to apply a force 5 in different directions.

[0170] The method for assisting a mother with the vaginal delivery of a foetus making use of an obstetrical vacuum extractor 10 comprises a number of important steps. The first step is applying the suction cup 20 to the head of the foetus. The operator may start developing a partial vacuum in the vacuum compartment 23 of the suction cup 20 when the suction cup 20 is applied to the head of a foetus. The vacuum is developed in the vacuum compartment 23 of the suction cup 20 by moving the actuating handle 42 from the first position 44 to the second position 45.

[0171] The vacuum level indicator 70 is continuously providing information about the vacuum level in the vacuum compartment 23 of the suction cup 20. Once a vacuum is developed, the operator may start applying a force 5 to the hand-held portion 40 to assist the mother with vaginal delivery. After assisting the mother with vaginal delivery, the vacuum can be released from the vacuum compartment 23 by lifting the relief tab 80. The suction cup 20 can be removed from the head on a foetus once the vacuum is removed from the vacuum compartment 23.

[0172] Returning to figures 3 and 4, a disassembled obstetrical vacuum extractor 10 is shown. The obstetrical vacuum extractor 10 is disassembled during the reprocessing process. The reprocessing process allows re-usage of the obstetrical vacuum extractor 10. Re-usage improves the sustainability of medical devices and could reduce the expenses for medical treatments. Each part can be reprocessed after the disassembling of the obstetric vacuum extractor 10. The device cannot be reprocessed properly when it is not disassembled. Body fluids may not be properly removed between the contacting surfaces of the separate components. Once each part is reprocessed, the obstetrical vacuum extractor 10 can be reassembled to re-use the obstetric vacuum extractor 10.

[0173] Each part of the obstetrical vacuum extractor complies with the ISO 17665 (moist heat), ISO 18472 (biological and chemical indicators) and ISO 20857 (dry heat) standards to be able to withstand the sterilising process to allow the re-usage of the obstetric vacuum extractor. These ISO standards provide the requirements for the development, validation and routine control of a sterilization process for medical devices.

[0174] Turning to figures 13 - 15, an obstetrical vacuum connector 100 for connecting a pump assembly 140 with a suction cup 20 of an obstetrical vacuum extractor 10 is shown. The connector 100 comprises a tube 102. The tube 102 is flexible and is configured to fluidly connect the pump 140 with the suction cup 20. The tube 102 has a wall 104 made of an elastic material, in particular of silicone rubber. The wall 104 defines an air channel 105 with an air inlet 106 and an air outlet 107. The air inlet 106 is positioned near a second coupling part 110. The second coupling part 110 is attached to the reinforcement 117 of the tube 102 and is configured to couple the tube with the suction cup 20. The opposite end 115 of end 111 is attached to a first coupling part 114. The first coupling part 114 is positioned near the air outlet 107 and is configured to couple the flexible tube 102 to the pump assembly 140.

[0175] One or more threads 117 extend from a first anchor 116 to a second anchor 112, substantially parallel from a central axis 108 of the air channel 105. The first anchor 116 is part of the first coupling part 114 and the second anchor 112 is part of the second coupling part 110. The one or more threads 117 are connected to both anchors 112, 116 so that the connector 100 is able to withstand the force exerted by an operator.

[0176] Turning to figures 16a - 16b, respectively two and three threads 117 are incorporated into the wall 104 of the flexible tube 102. The wall 104 may be a tubular wall 124. The threads are configured to resist a tensional force applied to the suction cup 20 via the tube 102. The threads 117 may be completely covered by the silicone of the wall 104 to prevent any contact between the threads 117 and the body fluids to simplify the reprocessing process. In case of multiple wires 117, as shown in figures 16a and 16b, the wires 117 are arranged rotationally symmetric in the tubular wall 104 with respect to the central axis 108 of the tube 102, which advantageously distributes the tensional forces evenly over the circumference of the tube 102. In figure 16a the wires 117 are arranged with a rotational symmetry of order 2, i.e. distributed with an intermediate angle of 180 degrees. In figure 16b the wires 117 are arranged with a rotational symmetry of order 3, i.e. distributed with an intermediate angle of 120 degrees.

[0177] Turning to figure 18, showing the wall 104 with one wire 117 incorporated into the wall 104 of the flexible tube 102. Figure 18 shows a small deviation from a completely tubular shape of the tubular wall 124. The wall 104 may also comprise different shapes such as squared or triangular. These different shapes could prevent collapsing due to the reached vacuum level in the flexible tube.

[0178] Returning to figure 4, the pump assembly 140 comprises a coupling part 142 which is configured to couple with the first coupling part 114 of the connector 100. Coupling part 142 and first coupling part 114 may form a bayonet coupling which can be coupled and decoupled easily. Returning to figures 13 and 15, the second coupling part 110 of the tube 102 is connected to the cup 20 in a central portion 21 of the cup 20. The connection is centralized to be able to divide the force exerted by the operator equally over the suction cup 20. The second coupling 110 further comprises a circular recess 113 which is configured to receive a tubular edge 22 of the central portion 21 of the cup 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, 113b. The first flange edge 113a is positioned close to the anchor and the second flange edge 113b is positioned further 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 transfer the forces, exerted by the tube to the suction cup 20. The second flange edge 113b is flexible to be able to dismantle the suction cup 20 from the flexible tube.

[0179] Fig. 17 shows another embodiment of the obstetrical vacuum connector. In this embodiment the wire(s) is differently connected at the suction cup sided end. The wires 117 and the second anchor 112 are incorporated into the suction cup 20. In this way, it is not possible to disassemble the flexible tube 102 from the suction cup 20. This improves the reprocessing of the obstetrical vacuum connector, as it is no longer required to take the parts apart, which may save time.

[0180] The obstetrical vacuum connector 100, is manufactured by providing at least one wire 117 in a mould. The wire 117 is then tensioned in the mould. A moulding core is provided in the mould to form the air channel 105 of the tube (not shown). The material for the first and second anchor, which may be a (thermo)plastic material, is cast into the mould. After the plastic material of the anchors is cast, silicone is cast inside the mould to form the tube. After the silicone is cured sufficiently the tube can be taken from the mould and the moulding core can be removed.

[0181] Turning to figures 19 - 22, in figure 19 an alternative embodiment of the pump assembly 1 for developing a vacuum in medical procedures, such as for developing a vacuum between a foetus’s head, is shown. Figures 20-22 show the pump assembly 1 in addition to a suction cup 20 of an obstetrical vacuum extractor 10 and an obstetrical vacuum connector 100. The pump assembly 1 in this embodiment is a diaphragm pump assembly. The diaphragm pump assembly 1 comprises a pump housing 30, a diaphragm 36 an actuating handle 42 and a chamber lid 50. The pump housing 30 is attached to a hand-held portion 40. The housing 30 has a cylindrical wall 31 and a bottom at one end thereof. The other end of the housing 30 is open. A diaphragm 36 is arranged on the housing 30 at the open end thereof. The chamber lid 50 is arranged on an outer side 39 of the bottom of the housing 30.

[0182] The pump assembly 1 comprises a vacuum level indicator 70 for providing information about the reached vacuum level in a suction cup 20. The vacuum level indicator 70 is connected to an air passage 41 through an indicator opening 150 of the pump housing 30. The vacuum level indicator comprises a bellows 154. The bellows 154 is in fluid communication with the suction cup 20 through the indicator opening 150. The bellows 154 is configured to, during use, expand or compress according to a pressure differential between the ambient pressure and a vacuum developed within the bellows 154.

[0183] The bellows 154 comprises a first bellows end 156, and a second bellows end 158. The second bellows end 158 is configured to be connected to a vacuum level indicator connector opening 160 of the chamber lid 50.

[0184] A bellows spring 162 having two legs forming substantially a V-shape, or alternatively a U-shape, is provided. The bellows spring has a first spring end 164 on one of the legs configured to be connected with the first bellows end 156 and a second spring end 166 on the other one of the legs configured to be connected with the chamber lid 50 of the pump assembly 1.

[0185] The vacuum level indicator 70 comprises a bellows spring 162, comprising a first spring end 164 configured to be connected with the first bellows end 156 and a second spring end 166. The second spring end 166 is configured to be connected with the chamber lid 50 of the pump assembly 1. The bellows spring 162 is configured to hold the first bellows end 156 in a first bellows position 168 relative to the chamber lid 50 when no vacuum is developed in the bellows 154.

[0186] The first bellows end 156 comprises at least one first bellows end connection element 170. The bellows spring 162 comprises a first spring end connector 172 which comprises at least one first spring end connector slot 174. The first spring end connector slot 174 is configured to receive the at least one first bellows end connection element 170 for connecting the first spring end 164 with the first bellows end 156, which in the embodiments of Figures 19 - 22 form a bayonet coupling. The skilled person will understand that other types of couplings are also possible. The second spring end 166 comprises a clamp 176 configured to removably connect the second spring end 166 to the chamber lid 50. A vacuum pressure gauge 178 of the vacuum level indicator 70 relates a state of expansion of the bellows 154 to a vacuum level in the suction cup 20. The vacuum pressure gauge 178 in Figures 19 - 22 is an analogue vacuum pressure gauge, which advantageously shows continuous changes in the vacuum level in the suction cup 20.

[0187] The bellows 154 comprise at least one reinforcement ring 180 space along a centre line 182 of the bellows 154. The at least one reinforcement ring 180 helps maintain the shape of the bellows 154 and helps prevent expansion of the bellows in a direction other than a direction along the centre line 182 of the bellows 154.

[0188] Alternatively or complementary to the at least one reinforcement ring 180, a reinforcement helix 184 may be used, wherein a centre line 186 of the reinforcement helix coincides with a centre line 182 of the bellows 154.

[0189] The chamber lid 50 comprises a chamber lid connection member 190 having a protrusion 194. The pump housing 30 comprises a corresponding connection recess 192 on an outer surface 39 of the pump housing 30. The protrusion 194 and the connection recess 192 are configured to couple with each other to fix the chamber lid 50 to the pump housing 30.

[0190] Turning to Figures 23a - 23b a cross-sectional view, a front view and a side view of the pump assembly 1 of Figures 19 - 22 are shown. In these figures, the bellows spring 162 holds the bellows 154 in a first bellows position 168.

[0191] Figures 24a - 24b depict the same views as shown in Figures 23a - 23b, only with the bellows in a compressed, or deformed, state. Figure 24c illustrates the vacuum pressure gauge 178 comprising markers 196 which indicate a vacuum level within the bellows.

[0192] Turning to Figures 25a - 25b, an alternative embodiment of an obstetrical vacuum connector 100 and a suction cup 20 are shown. The obstetrical vacuum connector 100 and the suction cup 20 are integrally connected to one another. This may be achieved through form-fitting and / or chemical bonding. One example of achieving an integral connection is through simultaneous casting of the obstetrical vacuum connector 100 and the suction cup 20.

[0193] Turning to Figures 26a - 26b, another side view and a cross-sectional view of the obstetrical vacuum connector 100 and suction cup 20 are shown. The cross-sectional view of Figure 26b shows two wires 117 incorporated into a wall 104 of a tube 102 of the obstetrical vacuum connector 100.

[0194] Figures 27a - 27c show a side view, a cross-sectional view and a bottom view of the obstetrical vacuum connector 100 and suction cup 20 of Figures 25a - 25b. A vacuum compartment 23 of the suction cup 20 comprises inner cup elements 194 on the vacuum compartment wall. The inner cup elements 194 are configured to provide equal vacuum pressure throughout the vacuum compartment 23.

[0195] Figures 28a - 28b show a different embodiment of the integrally connected obstetrical vacuum connector 100 and suction cup 20, wherein the first coupling part 114 comprises at least one protrusion 198 oriented radially outwards from a central axis 108 of the flexible tube 102 and wherein the first coupling part 114 is at least partially enclosed by the wall 104 of the flexible tube 102 so as to form a form-fit between the first coupling part 114 and the wall 104 of the flexible tube 102.

[0196] The first coupling part 114 and the wall 104 of the flexible tube 102 may also be integrally connected, in particular integrally connected through a chemical bond.

[0197] Again it is noted that although the connector 100 is described as being used as a obstetrical vacuum connector for use in an obstetrical vacuum extractor, it is envisaged that the connector 100 can be used for other applications, as was also mentioned in the foregoing.

[0198] Figure 29 depicts an embodiment of the pumping assembly 1, wherein the bellows 154 comprise a reinforcement helix 184 in addition to reinforcement rings 180. A centre line 186 of the reinforcement helix 184 coincides with a centre line 182 of the bellows 154.

[0199] Turning to figures 30 - 32 an alternative embodiment of the vacuum level indicator 70 is shown. The vacuum level indicator comprises a bellows 154 and a bellows spring 162 which are integrally connected to the chamber lid 50. The vacuum pressure gauge 178 is also integrally connected to the chamber lid 50.

Claims

CLAIMS1. Pump assembly (1) for developing a vacuum in medical procedures, such as for developing a vacuum between a foetus’s head and a suction cup (20) of an obstetrical vacuum extractor (10), the pump assembly comprising:- a pump housing (30) defining a pump chamber (32) and furthermore having an air inlet (34) and an air outlet (35) in fluid communication with the pump chamber,- a pumping member (36) arranged on or in the pump housing and configured to increase and decrease an internal volume of the pump chamber,- a chamber lid (50) arranged on an outside of the pump housing and covering a portion of the pump housing, wherein the chamber lid comprises an inlet valve flap (52) extending over the air inlet, wherein the air inlet and the inlet valve flap establish a one-way valve (53) configured to allow an inlet air flow (12) into the pump chamber when the internal volume of the pump chamber is increased.

2. Pump assembly according to the preceding claim, wherein the pump assembly furthermore comprises a hand-held portion (40) attached to or being part of the housing.

3. Pump assembly according to any of the preceding claims, further comprising a manually operated actuator (42) which is movable with respect to the pump housing from a first position (44) to a second position (45) and vice versa, wherein the manually operated actuator is coupled to the pumping member, such that the internal volume of the pump chamber is increased when the manually operated actuator is moved from the first position to the second position.

4. Pump assembly according to any of the preceding claims, wherein the pumping member is a diaphragm.

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

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

7. Pump assembly according to any of claims 4-6, further comprising: a diaphragm connection member (24) positioned in a central portion (25) of the diaphragm, wherein the diaphragm connection member is configured to connect with an actuator connection member (27),- the actuator connection member positioned at an upper part (28) of the manually operated actuator.

8. Pump assembly according to any of claims 3-7, wherein the manually operated actuator is disconnectable from the diaphragm to dismantle the pump assembly.

9. Pump assembly according to any of the preceding claims, wherein the chamber lid (50) furthermore comprises an outlet valve flap (54) extending over the air outlet, wherein the air outlet and the outlet valve flap establish a one-way valve (55) configured to allow an outlet air flow (13) out of the pump chamber (32) while the internal volume of the pump chamber (32) is decreased.

10. Pump assembly according to any of the preceding claims, wherein the pump housing further defines an air channel (131) which connects the air inlet with a channel inlet (132).

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

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

13. Pump assembly according to any of the preceding claims, wherein the pump housing (30) comprises at least one protruding connection member (38) positioned on an outer surface (39) of the pump housing (30) and the chamber lid (50) has at least one corresponding recess (56), wherein said at least one protruding connection member (38) and said at least one recess (56) are configured to couple with each other to fix the chamber lid (50) to the pump housing (30).

14. Pump assembly according to any of the preceding claims, wherein the pumping member (36) is positioned opposite to the chamber lid (50).

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

16. Pump assembly according to any of the preceding claims, wherein the chamber lid (50) comprises a vacuum level indicator (70) to provide information about the reached vacuum level in the suction cup (20).

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

18. Pump assembly according to the preceding claim, wherein the vacuum level indicator (70) comprises at least one deforming member (72) formed in the chamber lid (50), wherein the at least one deforming member (72) extends outwardly from an outer surface (74) of the chamber lid, and wherein the at least one deforming member (72) during use is allowed to deform by a vacuum developed below the at least one deforming member (72).

19. Pump assembly according to any of claims 16-18, wherein the vacuum level indicator (70) comprises a plurality of deforming members (72).

20. Pump assembly according to the preceding claim, wherein each deforming member (72) deforms at different vacuum levels due to varying wall thicknesses, varying sizes, varying shapes and / or additional reinforcements.

21. Pump assembly according to any of the two preceding claims, wherein an interconnection channel (69) provides fluid communication between the plurality of deforming members (72).

22. Pump assembly according to claim 16, wherein an indicator opening (150) connects the vacuum level indicator (70) to an air passage (41).

23. Pump assembly according to claim 22, wherein the vacuum level indicator comprises: a bellows (154) which is in fluid communication with the suction cup through the indicator opening, wherein the bellows is configured to, during use,expand or compress according to a pressure differential between the ambient pressure and a vacuum developed within the bellows, and wherein the bellows comprises: o a first bellows end (156) , and o a second bellows end (158) configured to be connected to a vacuum level indicator connector opening (160) of the chamber lid, and a bellows spring (162), wherein the bellows spring comprises a first spring end (164) configured to be connected with the first bellows end and a second spring end (166) configured to be connected with the chamber lid of the pump assembly, wherein the bellows spring is configured to hold the first bellows end in a first bellows position (168) relative to the chamber lid when no vacuum is developed in the bellows.

24. Pump assembly according to claim 23, wherein:- the first bellows end comprises at least one first bellows end connection element (170), and- the bellows spring comprises a first spring end connector (172), wherein the first spring end connector comprises at least one first spring end connector slot (174) configured to receive the at least one first bellows end connection element (170) for connecting the first spring end with the first bellows end.

25. Pump assembly according to any of claims 22 - 24, wherein the second spring end comprises a clamp (176) configured to removably connect the second spring end to the chamber lid.

26. Pump assembly according to any of claims 22 - 25, wherein the vacuum level indicator comprises a vacuum pressure gauge (178), in particular an analogue vacuum pressure gauge, to relate a state of expansion of the bellows to a vacuum level in the suction cup (20).

27. Pump assembly according to any of claims 22 - 26, wherein the bellows comprise at least one reinforcement ring (180) spaced along a centre line (182) of the bellows.

28. Pump assembly according to any of claims 22 - 27, wherein the bellows comprise a reinforcement helix (184), wherein a centre line (186) of the reinforcement helix coincides with a centre line (182) of the bellows.

29. Pump assembly according to any of claims 22 - 28 wherein the chamber lid comprises a chamber lid connection member (190) having a protrusion (194) and the pump housing (30) comprises a corresponding connection recess (192) on an outer surface (39) of the pump housing (30), wherein said protrusion (194) and said connection recess (56) are configured to couple with each other to fix the chamber lid (50) to the pump housing (30).

30. Pump assembly according to any of the preceding claims, wherein the chamber lid comprises a relief tab (80) configured to lift the chamber lid (50) at least partially from the pump housing 30 to relieve the vacuum from the connection channel (62) and thereby eventually between the head of a foetus and the suction cup (20).

31. Pump assembly, according to any one of the preceding claims, wherein the chamber lid is a flexible plate (51) made of an elastic material, in particular of silicone rubber.

32. Pump assembly according to any of the preceding claims, wherein the housing or the hand-held portion comprises a first coupling member (48) configured to couple with a second coupling member (92) of a tube (90).

33. Obstetrical vacuum extractor (10) to assist a mother with the vaginal delivery of a foetus, the obstetrical vacuum extractor comprising:- the pump assembly according to any of the preceding claims,- a suction cup (20) configured to be applied to the head of a foetus,- a tube (90) to fluidly connect the pump assembly to the suction cup.

34. Obstetrical vacuum extractor according to the preceding claim, wherein the air inlet of the pump chamber (32) is in fluid communication with the tube (90) by an air passage (41) in the housing or the hand-held portion.

35. Obstetrical vacuum extractor according to any claims 33-34, wherein the tube (90) is a flexible tube (93).

36. Obstetrical vacuum extractor according to any of claims 33-35, wherein a suction cup coupling (120) between the tube (90) and the suction cup (20) is a flexible coupling (122) configured to provide more freedom for the operator to apply a force(5) in different directions.

37. Obstetrical vacuum extractor according to any of claim 33-36, wherein the suction cup (20) comprises at least one vacuum compartment (23).

38. Method for assisting a mother with the vaginal delivery of a foetus making use of an obstetrical vacuum extractor according to any one of the claims 33-37, the method comprising: applying the suction cup (20) to the head of the foetus, developing a vacuum in the vacuum compartment of the suction cup (20), applying a force to the housing or hand-held portion to assist the mother with vaginal delivery, releasing the vacuum from the vacuum compartment of the suction cup (20), removing the suction cup (20) from the head of the foetus.

39. Method for reprocessing the obstetrical vacuum extractor (10) according to any one of claims 33-37, wherein the method comprises: disassembling the obstetric vacuum extractor (10), cleaning each part of the obstetric vacuum extractor (10), disinfecting each part of the obstetric vacuum extractor (10), reassembling the obstetric vacuum extractor (10), sterilising the obstetric vacuum extractor (10), wherein each part of the obstetrical vacuum extractor (10) complies with the ISO 17665, ISO 18472 and ISO 20957 standards to be able to withstand the sterilising process to allow the re-usage of the obstetric vacuum extractor (10).

40. Obstetrical vacuum connector (100) for connecting a pump assembly (140) with a suction cup (20) of an obstetrical vacuum extractor (10), the obstetrical vacuum connector (100) comprising: a flexible tube (102) to fluidly connect the pump assembly to the suction cup, wherein the tube has a wall (104), the wall defining an air duct (105) and furthermore having an inlet (106) and an outlet (107), a first coupling part (114) attached to a first side (115) of the flexible tube and configured to couple the flexible tube to the pump assembly, wherein at least one wire (117) is incorporated in the wall, which wire is configured to resist a tensional force applied to the suction cup via the tube.

41. Obstetrical vacuum connector according to the preceding claim, wherein a second coupling part (110) is attached to a second side (111) of the flexible tube (102) and is configured to couple the flexible tube (102) to the suction cup (20).

42. Obstetrical vacuum connector according to any of claims 40-41, wherein the tube (102) is made of an elastic material, in particular of silicone rubber.

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

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

45. Obstetrical vacuum connector according to any of claims 40-44, wherein the first coupling part comprises a first anchor (116) and the second coupling part comprises a second anchor (112), and wherein at least one wire is connected to the first anchor (116) and the second anchor (112).

46. Obstetrical vacuum connector according to any of claims 40-45, wherein the at least one wire comprises a plurality of wires (117), which are arranged rotationally symmetric in the wall with respect to the central axis of the tube.

47. Obstetrical vacuum connector according to any of claims 40-46, wherein the wall is a tubular wall (124).

48. Obstetrical vacuum connector according to any of claims 40-47, wherein the second anchor (112) is incorporated into the suction cup (20).

49. Obstetrical vacuum connector according to any of claims 40-48, wherein the first coupling part (114) comprises at least one protrusion (198) oriented radially outwards from a central axis (108) of the flexible tube (102) and wherein the first coupling part is at least partially enclosed by the wall (104) of the flexible tube (102) so as to form a form-fit between the first coupling part and the wall of the flexible tube.

50. Obstetrical vacuum connector according to any of claims 40-49, wherein the first coupling part (114) and the flexible tube (102) are integrally connected, in particularintegrally connected through a chemical bond.

51. Obstetrical vacuum extractor (10) to assist a mother with the vaginal delivery of a foetus, the obstetrical vacuum extractor comprising:- a suction cup (20) configured to be applied to the head of a foetus,- a pump assembly (140) for developing a vacuum,- the obstetrical vacuum connector (100) according to any of claims 40-50, for interconnecting the suction cup (20) and the pump assembly (140) so as to provide the vacuum developed by the pump assembly (140) to the suction cup (20).

52. Obstetrical vacuum extractor according to the preceding claim, wherein pump assembly (140) comprises a pump assembly coupling part (142) configured to couple with the first coupling part of the obstetrical vacuum connector.

53. Obstetrical vacuum extractor according to any of claims 51-52, wherein the suction cup has a central opening (21) configured to couple with the second coupling part of the obstetrical vacuum extractor (10), wherein a circular edge (22) of the central opening is configured to be positioned in a tubular recess (113) of the second coupling part.

54. Obstetrical vacuum extractor according to any of claims 51-53, wherein the obstetrical vacuum connector (100) is disconnectable from the pump assembly to dismantle the obstetrical vacuum extractor (10).

55. Obstetrical vacuum extractor according to any of claims 51-54, wherein the obstetrical vacuum connector (100) is disconnectable from the suction cup (20) to dismantle the obstetrical vacuum extractor (10).

56. Method for manufacturing an obstetrical vacuum connector, the method comprising: providing at least one wire in a mould, tensioning the at least one wire in the mould, casting the material for a first anchor around a portion of the wire and a second anchor around a portion of the wire remote from the first anchor, casting a silicone material inside the mould such that the wire at least between the first and second anchor is embedded in the silicone material,providing a moulding core in the mould to form a tube from the silicone material, removing the mould and moulding core.

57. Method for manufacturing an obstetrical vacuum connector, the method comprising: casting material for a first anchor and a second anchor in a first mould, removing the first anchor and second anchor from the first mould and placing the first anchor and second anchor in a second mould, providing at least one wire in the second mould, wherein the at least one wire is connected to the first and second anchor, providing a moulding core in the mould to form a tube from cast silicone material, tensioning the at least one wire in the mould, casting a silicone material inside the mould such that the at least one wire is embedded in the silicone material, removing the mould and moulding core.

58. Method according to claim 56 - 57, wherein the silicone material is cast partially around the first and second anchor.

59. Method according to any of claims 56 - 58, wherein a suction cup is cast alongside the obstetrical vacuum connector, forming an integral connection between the obstetrical vacuum connector and the suction cup.

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