Vacuum aspirator for fetal head

Abstract

The invention provides a fetal head vacuum aspirator which comprises a near-end handle, a far-end suction cup and a traction component, and the traction component pulls the suction cup from the handle so as to provide auxiliary traction in the delivery process. The proximal handle includes a distal end portion that reciprocatingly receives a proximal end portion, where the distal end portion defines a neck that interfaces the traction member. A shoulder adjacent the neck provides a gripping surface for gripping relative to an index finger. The handle is manually and repeatedly pressed to operate the mechanical pump, and the mechanical pump generates suction force in the suction cup through the pneumatic pipe. A dynamometer in the handle is provided with a haptic protrusion extending through the shoulder, providing haptic force feedback to monitor the applied tension. The aspirator may also include a bending point marker on the traction member that enables precise alignment of the suction cup with a fetal bending point and monitoring of traction progression.

Description

Technical Field

[0001] This invention relates to medical devices, and more specifically to a fetal head vacuum extractor used during childbirth to assist in the delivery of an infant by providing auxiliary or corrective traction to the fetal head during labor traction. Background Technology

[0002] During vaginal delivery, the fetus must pass through the birth canal after the mother's cervix has fully dilated. Because the fetal head is relatively large compared to the birth canal, this process can be physically demanding, requiring significant stretching of the vaginal tissues. While natural forces such as maternal exertion and uterine contractions help in this process, sometimes these forces may be insufficient or unsuitable for achieving a safe and timely delivery.

[0003] Specifically, prolonged or obstructed labor, weak uterine contractions, maternal fatigue, fetal distress, or malposition of the fetal head can create numerous difficulties during delivery, hindering its progress. These situations may require additional assistance to ensure the safe delivery of the fetus. Traditional forceps are often used to provide necessary traction, but they carry certain risks. Due to their rigid structure, forceps can potentially cause injury to both the mother and fetus, including fetal head injury and maternal discomfort.

[0004] To address these risks, alternative methods such as vacuum-assisted delivery have been developed. However, traditional vacuum extraction devices also present challenges, including the difficulty in precisely controlling the applied force, which can lead to excessive traction and related complications. Other difficulties include the challenge of accurately monitoring the progress of the procedure and accurately positioning the suction cup at the fetal flexion point, further complicating the delivery process.

[0005] Therefore, it is necessary to develop improved methods and equipment to assist in the delivery of the fetus in a controlled and safe manner, ensuring delivery efficiency while minimizing the risk of injury when natural labor forces alone are insufficient. Summary of the Invention

[0006] The vacuum aspirator includes a proximal handle, a distal suction cup, and a traction member. The traction member connects the suction cup to the handle and pulls the suction cup from the handle to assist in generating traction during labor. The proximal handle consists of a distal portion that reciprocates to receive the proximal portion, wherein the distal portion defines a neck that abuts against the traction member. This neck structure provides a secure connection, while the shoulder adjacent to the neck provides a gripping surface for the operator's index finger, thus enabling a stable grip during use.

[0007] The handle is designed for single-handed pulling and repeated pressing. The distal and proximal sections are designed for manual, repeated pressing to operate the mechanical pump, which connects to a pneumatic tube in the traction component to generate suction within the suction cup. The advantage of this design is its ease of operation; the operator can maintain a single-handed grip while generating the required suction, freeing up the other hand for additional tasks when necessary.

[0008] A key feature of vacuum extractors is the built-in force gauge in the handle. This force gauge, displaced by the traction mechanism under tension, includes tactile protrusions extending through the shoulder of the handle. These protrusions provide tactile feedback to the operator, alerting them to excessive tension without visual confirmation. This is particularly beneficial in vacuum-assisted delivery, where excessive stretching can lead to fetal scalp injury or other complications. This non-visual cue allows the operator to focus on the procedure itself, enabling intuitive adjustments to force and reducing the risk of injury to the fetus.

[0009] The combination of the handle design and the force gauge, while ensuring enhanced safety through the feedback mechanism, allows for controlled application of traction, making the suction device both efficient and safe for assisting childbirth.

[0010] Preferably, the fetal head vacuum aspirator includes a flexion point slider marker located on the pneumatic tube of the traction member. This allows the operator to visually track the insertion distance of the suction cup, ensuring proper alignment with the fetal flexion point. Proper alignment of the suction cup with the flexion point is crucial for effective and safe traction during delivery, as it reduces the risk of failed vacuum aspiration attempts or fetal injury due to improper positioning. The marker helps the operator measure and monitor the fetal progress through the birth canal, providing a reliable visual reference for accurate cup placement and assessment of traction progress during the procedure. Preferably, the fetal head vacuum aspirator also includes a timer that clearly indicates the elapsed time during vacuum-assisted delivery. This is particularly beneficial given the recommended time limits for vacuum-assisted delivery, which typically help avoid complications such as prolonged pressure on the fetus. The timer is designed to help the operator adhere to these time limits, thereby reducing the likelihood of adverse outcomes. The timer may include a dye-core system that advances over a preset time, providing continuous visual monitoring of the procedure duration without the need for additional external equipment.

[0011] According to one aspect, a fetal head vacuum extractor is provided, including a proximal handle, a distal suction cup, and a traction member. The traction member is configured to pull the suction cup from the proximal handle to provide auxiliary traction during labor. The proximal handle includes a distal portion that reciprocates to receive the proximal portion, wherein the distal portion defines a neck that engages with the traction member. A shoulder adjacent to the neck provides a gripping surface for relative index finger grasping, thereby enabling a stable grip during the procedure. Manually pressing repeatedly on the distal and proximal portions operates a mechanical pump, which engages with a pneumatic tube in the traction member to generate suction in the suction cup. The handle includes a force gauge connected to the traction member, the force gauge including tactile projections extending through the shoulder to provide tactile feedback to the operator's fingers when sufficient force is applied. This arrangement allows the operator to monitor and control the applied force without continuous visual confirmation, thereby improving safety and efficiency during delivery.

[0012] Optionally, the force gauge may include a frill structure having a pair of side rails connected to a pneumatic tube connector. This connector pneumatically engages with the pneumatic tube, and the force gauge provides tactile feedback when a force is sufficient to displace the pneumatic tube connector relative to the frill structure. This arrangement ensures reliable force monitoring through robust mechanical construction, thereby improving surgical safety by detecting excessive force.

[0013] Preferably, the traction rope extends through the pneumatic tube, and both ends of the traction rope can be secured using cup beads and force-measuring beads. The use of the traction rope in conjunction with these beads ensures that the traction force is reliably transmitted through the pneumatic tube, thereby reducing the risk of system failure during use.

[0014] Optionally, the traction cord can be looped back and forth between the suction cup and the handle, doubling the cord length within the pneumatic tube. This configuration enhances the durability of the traction system. In another preferred embodiment, the cup bead may include barbs configured to receive the traction cord and achieve a pneumatic seal within the distal end of the pneumatic tube. This ensures that the vacuum generated within the suction cup can be maintained without leakage, thereby reducing the likelihood of surgical failure due to loss of suction.

[0015] In addition, the cup bead may include a distal retainer for engaging with the distal end of the traction cord, thereby further securing the traction system and ensuring that the applied force is reliably transmitted from the handle to the suction cup.

[0016] Preferably, the force-measuring bead can be held entirely within the proximal end of the pneumatic tube, allowing it to mate with the force gauge. This positioning method ensures that the force gauge can accurately measure the force applied through the traction rope, thereby improving the safety and effectiveness of the equipment.

[0017] The force-measuring bead may include a connecting portion for securing the traction rope, the connecting portion being shaped to interfere with the corresponding contour of the circumferential cylinder of the force gauge. This feature ensures that the traction force can be transmitted directly from the rope to the force gauge, thus providing accurate feedback on the applied force. Optionally, the force-measuring bead may include an air passage support to ensure unobstructed airflow within the pneumatic tube, thereby maintaining the integrity of the vacuum system during use.

[0018] A compression spring can be configured to bias the cylinder block in the proximal direction. This feature provides a force opposite to traction, ensuring the system returns to its neutral position when no traction is applied, thereby enhancing maneuverability and ease of use.

[0019] The pneumatic tubing may include a slack section between the force-sensing ball and the pump, allowing the ball to move relative to the pump under tension. This design helps maintain accurate force measurement and vacuum integrity while also contributing to smooth operation of the traction system.

[0020] In a preferred embodiment, the suction device may include a vacuum gauge operatively coupled to the pump. The vacuum gauge is characterized by having an elongated bellows that mechanically engages with an indicator, wherein the bellows contracts longitudinally under working vacuum pressure, thereby displacing the indicator. This provides the operator with a clear visual indication of when sufficient vacuum pressure has been reached, thus aiding in providing appropriate suction during the procedure. Optionally, the bellows may include a series of pleats, the pitch of which is configured to allow the bellows to contract longitudinally under working vacuum pressure. This improves the accuracy of the vacuum gauge, thereby providing reliable feedback on the vacuum pressure level.

[0021] Alternatively, the vacuum gauge can be operatively connected to the pump, wherein the markings on the handle are aligned with the markings on the pump at the operating vacuum pressure. This provides a simple and reliable method for maintaining an appropriate vacuum level during use.

[0022] The mechanical pump may also include a manifold that pneumatically connects to the cylinder block in the proximal section, thereby enabling efficient pressure transmission between the pump and the suction cup. This configuration ensures reliable and efficient suction generation.

[0023] A compression spring can be installed to bias the proximal portion in the proximal direction to achieve reciprocating operation of the mechanical pump and maintain system stability during use.

[0024] The manifold can interface with exhaust and intake valves, facilitating controlled air intake and exhaust to maintain a vacuum. Optionally, the intake valve can be a diaphragm valve that seals against a radially offset outlet port, thereby enabling the desired airflow control within the system.

[0025] One of the outlet ports can be connected to a pneumatic tube to ensure that a constant vacuum pressure is transmitted to the suction cup.

[0026] Another outlet port can be connected to a vacuum release mechanism, allowing the operator to safely and efficiently release the vacuum after the operation.

[0027] Preferably, the vacuum release mechanism may include a trigger operable in the distal direction to prevent accidental release of vacuum when the handle is pulled in the proximal direction.

[0028] The vacuum release mechanism may also include a pneumatically sealed plunger, with a trigger engaging the plunger to release its pneumatic seal. This ensures a safe and controlled vacuum release for removing the suction cup.

[0029] Optionally, a stroke delay coupling can be provided between the trigger and the plunger to ensure that vacuum is released only after the trigger has traveled a sufficient distance. This feature prevents accidental vacuum release during use.

[0030] A biasing mechanism (such as a hinged compression spring) can be used to reset the trigger after vacuum release.

[0031] The trigger is exposed at the neck of the handle for easy operator access and can efficiently release the vacuum when appropriate.

[0032] Preferably, the bottom surface of the handle may include a muscle memory forming structure that indicates the position of the flexion point, for memorizing the correct placement of the suction cup relative to the fetal head, thereby improving alignment accuracy during the procedure.

[0033] The muscle memory formation structure is approximately 3 cm long, representing the typical distance from the posterior fontanelle to the flexion point. This ensures that the suction cup is correctly positioned during delivery, thus providing optimal traction.

[0034] According to another aspect, a method for using a fetal head vacuum aspirator is provided. The method includes positioning a suction cup on the fetal head and manually and repeatedly pressing the proximal and distal portions of the handle to create a vacuum within the suction cup via a pneumatic tube. This vacuum secures the suction cup to the fetal head. The operator applies traction via a traction member to assist delivery, wherein tactile protrusions of a force gauge provide tactile force feedback to indicate whether the applied traction is excessive, without visual monitoring. This helps the operator adjust the force as needed during delivery, thereby enhancing maneuverability and reducing the risk of overstretching.

[0035] Alternatively, the method may include using flexion point markers on the traction member to ensure proper alignment of the suction cup with the fetal flexion point. This ensures precise positioning of the suction cup, thereby optimizing the effect of the applied traction.

[0036] Preferably, the method includes monitoring the progress of the suction cup while assessing the magnitude of the applied force through tactile feedback from a force gauge, without continuously observing the handle, thereby providing a safer and more intuitive method of force application during delivery.

[0037] Furthermore, the method may include operating a vacuum release mechanism to release the vacuum. The operator can pull the trigger to disengage from the plunger, thereby releasing the vacuum within the suction cup and allowing the suction cup to be safely removed from the fetal head. A stroke delay coupling ensures that the vacuum is released only when the trigger is intentionally pulled beyond a certain threshold, thus preventing accidental vacuum release.

[0038] This method provides a safe and efficient way to apply assisted traction during childbirth, where feedback mechanisms and visual markers help improve the accuracy and safety of the procedure.

[0039] Other aspects of the invention are also disclosed. Attached Figure Description

[0040] Although any other forms may fall within the scope of this invention, preferred embodiments of this disclosure will now be described by way of example only with reference to the accompanying drawings, in which: Figure 1 A top perspective view of the head vacuum aspirator 100 is shown; Figure 2 A bottom perspective view of the suction device 100 is shown; Figure 3 This is an exploded view of the attractor 100, showing its various components; Figure 4 This is an exploded view of the handle 101 of the suction device 100; Figure 5 The structure of the suction cup 102 and its various components are shown in detail, including the lower cup part, the upper cup part and the opening; Figure 6 The diagram shows the dip point marker 164 and its frictional engagement with the pneumatic tube 103; Figure 7 The internal protrusion 166 of the marker 164 is shown in connection with the pneumatic tube 103; Figure 8 An alternative embodiment of the marker 164 is shown, which has a star-shaped cross-section hole; Figure 9 The diagram shows the traction rope 120 and its arrangement as it passes through the pneumatic tube 103; Figure 10 The bottom surface of the cup bead 121 used to secure the traction rope is shown; Figure 11 A top view of the cup bead 121 is shown; Figure 12A perspective view of the force-measuring bead 122 is shown; Figure 13 The front view of the force-measuring bead 122 is shown; Figure 14 The docking state of the force gauge 112 of the suction device 100 with the force measuring bead is shown; Figure 15 Force gauge 112 is shown; Figure 16 A vacuum gauge 135 is shown in one embodiment, which has an elongated bellows 136 and an indicator 137. Figure 17 The vacuum release mechanism 157 is shown, with its trigger portion 159 docking with the plunger 160; Figure 18 A front perspective view of manifold 144 is shown, which is connected to the pneumatic cylinder of the access end portion 110; Figure 19 A rear perspective view of manifold 144 is shown; Figure 20 Alternative embodiments of the force-measuring bead 122 are shown; and Figure 21 Alternative embodiments of the dip point marker 164 are shown. Detailed Implementation

[0041] Figure 1 A head vacuum aspirator 100 is shown, including a proximal handle 101, a distal suction cup 102, and a traction member 179 located between the two. The traction member 179 includes a pneumatic tube 103 that facilitates the suction function. In this description, the term "distal" refers to the direction toward the suction cup 102, while "proximal" refers to the direction toward the handle 101.

[0042] The suction cup 102 may include an internal sponge 104, which can be secured by adhesive backing. (Reference) Figure 5 The suction cup 102 may include a lower cup portion 102A, which docks with an upper cup portion 102B, the latter defining an opening 105. The lower cup portion 102A is characterized by having an integrally formed channel 106 that connects to the distal end of the pneumatic tube 103, thereby ensuring vacuum transfer between the pump and the suction cup 102.

[0043] The handle 101 houses a manual pneumatic pump, which is connected to the pneumatic tube 103. The handle 101 includes a distal portion 107 that tapers to form a neck 108, which connects to the traction member 179; and shoulders 109 located on either side of the neck 108, defining a gripping surface for the operator to hold with two index fingers (typically the index and middle fingers). The proximal portion 110 of the handle 101 reciprocates within the housing 111 and is manually and repeatedly pressed by the palm of the hand, thereby creating the necessary vacuum within the suction cup 102 to secure it to the fetal head. The handle 101 is then pulled to apply auxiliary or corrective traction during labor.

[0044] refer to Figure 3 The housing 111 may include a lower housing portion 111A and an upper housing portion 111B. The suction device 100 also includes a force gauge 112 (such as...). Figure 15 As shown), the force gauge 112 is characterized by tactile protrusions 113 extending through the shoulder 109 of the handle 101 to provide tactile feedback. The force gauge 112 may also include visual force markers 173 extending distally through a preview cutout 174 in the handle 101 to provide a visual indication of the applied force, such as... Figure 1 As shown. Under the action of a greater force, the marker 173 can extend coaxially from the distal end of the handle 101 to warn the operator of excessive force.

[0045] In this embodiment, the force gauge 112 includes a fork member 114 that slides along a pair of side rails 115. The fork member 114 is connected to a pneumatic tube coupling 116, which houses a cylinder 117 that is pneumatically connected to a pneumatic tube 103. When a pulling force is applied to the handle 101, the housing 111 moves proximally relative to the pneumatic tube coupling 116, thereby displacing the fork member 114 through the pickup hole 175 and the hook 178. Then, a tactile protrusion 113 extends through a port 118 on the shoulder 109 (e.g., ...). Figure 2 As shown in the figure, this provides tactile feedback to the operator's fingers during use.

[0046] The pneumatic hose coupling 116 is balanced by a compression spring 119. When sufficient traction is applied, it overcomes the resistance of the compression spring 119, causing the pneumatic hose coupling 116 to pull the fork member 114, thereby causing the tactile protrusion 113 to protrude from the port 118 on the handle 101. This feedback allows the operator to reduce the pulling force without visually inspecting the handle 101. Furthermore, the visual force marker 173 provides the operator or assistant with additional visual confirmation of the applied force.

[0047] like Figure 9As shown, the suction device 100 may include a traction rope 120 that extends through the pneumatic tube 103. While the pneumatic tube 103 may experience slight stretching, the traction rope 120 will not. In a preferred embodiment, the traction rope 120 is a steel wire rope with a diameter of 0.6 mm, which increases to a total diameter of 0.8 mm after being coated with a transparent polyamide (PA). The proximal end of the pneumatic tube 103 may have a larger orifice to accommodate the force-measuring bead 122.

[0048] Furthermore, the suction device 100 is characterized by having a cup bead 121 and a force-measuring bead 122, each of which fixes one end of the traction rope 120. The traction rope 120 may be looped, thus forming two strands within the pneumatic tube 103. (Reference) Figure 10 and Figure 11 The cup bead 121 may have barbs 123 that receive the traction rope 120 and seal it within the distal end of the pneumatic tube 103. The barbs 123 may include a proximal terminating ring 124 that secures the distal end of the pneumatic tube 103 through an integrally formed channel 106.

[0049] The cup bead 121 may have a distal retainer 126. For example... Figure 5 As shown, a rope knot 127 can be attached to the end of the traction rope 120. (Reference) Figure 9 The traction rope 120 can be bypassed by the distal retainer 126, while the rope buckle 127 secures the rope to the cup bead 121 or the force measuring bead 122.

[0050] like Figure 14 As shown, the force-measuring bead 122 can be completely accommodated within the proximal portion of the pneumatic tube 103. The cylinder 117 of the force gauge 112 surrounds the force-measuring bead 122 within the proximal portion of the pneumatic tube 103. The force-measuring bead 122 includes an engagement portion 128 for securing the traction rope 120. The shape of the engagement portion 128 is adaptable to the narrow portion 131 surrounding the cylinder 117, thereby transmitting traction force from the traction rope 120 to the force gauge 112.

[0051] The engagement portion 128 is characterized by having a longitudinal channel 129 and a through hole 130 through which the loop of the traction rope 120 can be threaded. Both the engagement portion 128 and the narrowing portion 131 of the cylinder body 117 can gradually narrow towards the distal end, thereby ensuring a firm engagement between the two. To maintain proper airflow, the force-measuring bead 122 may include pneumatic supports 132. These supports may include secondary supports 132A on the engagement portion 128 and a main support 132B located near the end of the alignment rod 133. Figure 20An alternative embodiment of the force-measuring bead 122 is shown, which has a generally elongated body 188; the body is designed to fit within the proximal end of a pneumatic tube 103; the pneumatic tube defines a lumen 191 through which airflow passes and also defines a tapered distal end 189; when positioned within the pneumatic tube 103, the tapered distal end can wedge into a narrowing 131. The body 188 may define a proximal side groove 190 that engages with respective ends of a cord catch 127, which engages the proximal end of a traction cord 120. The groove 190 may also define a support therebetween to prevent the pneumatic tube 103 from collapsing under suction. The outer diameter of the body 188 may be 4.9 mm and it may be made of polycarbonate.

[0052] Figure 14 A proximal ring 134 is also shown, which abuts against the proximal end of the compression spring 119. The proximal portion of the pneumatic tube 103 may have a relaxed configuration, such as a bend or S-shaped bend, to facilitate movement of the force gauge bead 122 during traction. The proximal portion of the pneumatic tube 103 may include an internal spring to mitigate tube collapse or blockage that may result from suction, tensile loads, or movement of the force gauge 117.

[0053] Figure 20 An alternative embodiment of the force bead 122 is shown, described as having an outer diameter of 4.9 mm and being made of polycarbonate (PC) in a through-hole design.

[0054] refer to Figure 16 The suction device 100 may also include a vacuum gauge 135 operatively connected to the pump. The vacuum gauge 135 may be constructed of an elongated bellows 136 made of rubber, which mechanically engages with an indicator 137. When the internal pressure drops below a threshold, the bellows 136 contracts longitudinally, thereby driving the indicator 137 to move. The distal end of the bellows 136 may include an orifice 138 that engages with barbs 139 on the indicator 137. The indicator 137 may have two colored portions: a first colored portion 140A and a second colored portion 140B. Figure 4 As shown, these colored portions can be seen through the window 141 on the handle 101. Normally, the second colored portion 140B is visible when the vacuum level is insufficient; however, as the bellows 136 contracts, the first colored portion 140A becomes visible.

[0055] The bellows 136 is characterized by having pleats 143, the pitch of which is designed to cause the bellows to contract upon reaching the working vacuum pressure. The clinician must repeatedly press the proximal portion 110 until the vacuum gauge 135 indicates that a sufficient vacuum has been achieved. In an alternative embodiment, the vacuum gauge 135 may function as a pump and spring, with alignment marks on the handle 101 to indicate when the working vacuum pressure has been reached.

[0056] refer to Figure 18 and Figure 19 The suction device 100 may include a manifold 144 that interfaces with a pneumatic cylinder of the proximal portion 110. The proximal portion 110 can be biased proximally by compression springs 145 acting on cylindrical supports 146 of the manifold 144. The manifold 144 may include a piston 147, which is sealed within the pneumatic cylinder by an O-ring 148. The piston 147 is characterized by an intake valve 149, which is a diaphragm valve and is fixed via a central bore 150 on the piston.

[0057] On the distal side, piston 147 may include an exhaust valve 155 located within exhaust valve port 156. In some embodiments, suction device 100 is characterized by having a combined intake and exhaust valve that incorporates both intake valve 149 and exhaust valve 155. Intake valve 149 is sealed against a radially offset outlet port 151. When proximal portion 110 moves proximally, intake valve 149 allows air to enter the pneumatic cylinder through outlet port 151. When proximal portion 110 moves distally, intake valve 149 blocks outlet port 151, while exhaust valve 155 expels air to create the desired vacuum.

[0058] refer to Figure 19 One of the outlet ports 151 can be connected to the pneumatic pipe connector 152, another to the vacuum gauge connector 153, and the third to the vacuum release connector 154.

[0059] refer to Figure 17 The suction device 100 is characterized by having a vacuum release mechanism 157, which includes a trigger portion 159 and a trigger 158. For example... Figure 2 As shown, trigger 158 is exposed on the lower surface of neck 108. Trigger 158 is operated distally to prevent accidental triggering when handle 101 is pulled proximally.

[0060] The vacuum release mechanism 157 may also include a plunger 160 with a seal 161, the plunger being secured within the vacuum release connector 154 by an O-ring 176. By default, the plunger 160 is biased into the vacuum release connector 154 to maintain a pneumatic seal. When the trigger 158 is pulled, the plunger 160 disengages from the O-ring 176, thereby releasing the vacuum generated by the pneumatic pump.

[0061] The vacuum release mechanism 157 is designed to prevent accidental release, requiring the trigger 158 to be pulled beyond a certain distance before triggering accidental release. Mechanism 157 may include a travel delay coupling between the trigger portion 159 and the plunger 160. The trigger portion 159 is characterized by a larger hole 162 through which a hook on the plunger 160 can be inserted. By default, the hook 163 remains at the distal end of the hole 162. When the trigger 158 is pulled, the hook 163 travels through the hole 162 until it contacts the proximal wall, thereby engaging the plunger 160. The trigger portion 159 is biased proximally by an integrally formed laterally movable compression spring 177.

[0062] like Figure 1 As shown, the suction device 100 may also include a flexion point marker 164 that slides along the pneumatic tube 103. The marker 164 can be positioned to indicate the distance from the flexion point, facilitating alignment of the center of the suction cup 102 with the flexion point. The flexion point marker 164 can also be used for visual tracking of the fetus's progress in the birth canal.

[0063] In an alternative embodiment, the suction device 100 is characterized by having two sliders 164: a first marker indicates the starting point, and a second marker tracks progress. The clinician positions the two markers at the diagnosed insertion distance to facilitate accurate placement of the suction cup 102 above the flexion point. As the procedure progresses, after each traction, the second marker 164 is moved to the frenulum of the labia to indicate the fetal progress in the birth canal.

[0064] refer to Figure 6 and Figure 7 The marker 164 includes a cylinder 165, whose internal protrusion 166 is frictionally engaged with the pneumatic tube 103. Figure 8 An alternative embodiment is shown, wherein the marker 164 is characterized by having a star-shaped hole 167 for engaging with the pneumatic tube 103 in a similar manner.

[0065] Figure 21A disassembled view of a flexion point marker 164 according to another embodiment is shown. The marker 164 is operable in a compression configuration to release the pneumatic tube 103, thereby sliding along it; the marker is also operable in a released state, in which it clamps the pneumatic tube 103 to hold it in place. According to the illustrated embodiment, the marker 164 includes a body 180 (preferably spherical for gripping between an index finger) and a button 181 slidably held within the body. The body 180 defines a main through-hole 182A, while the button 181 defines a secondary through-hole 182B. A compression spring 183 biases the button 181 to the release configuration, and the button 181 may include a side rail 184 that slidably engages with a corresponding slot in the body 180. A latch 186 on the button 181 engages with a corresponding inner latch 187 within the body 180 to prevent the button 181 from disengaging from the body 180 under the compressive force of the compression spring 183. When button 181 is pushed into body 180, holes 182 align coaxially with pneumatic tube 103, allowing marker 164 to slide along pneumatic tube 103. Internal support member 188 restricts button 181 movement to prevent over-insertion and is positioned and configured such that holes 182 are precisely aligned when the lower surface of button 181 contacts support member 188. In the compressed state, marker 164 can be positioned at a desired location on pneumatic tube 103. Once button 181 is released, compression spring 183 removes it from body 180, causing holes 182 to misalign and clamp pneumatic tube 103, thus preventing button movement along pneumatic tube.

[0066] refer to Figure 3 The aspirator 100 may include a disposable core timer 168 attached to a handle 101. The timer 168 is activated by pressing a button 169, which, upon breaking, releases dye along the core 170. The dye reaches the marker contact after a predetermined time interval (e.g., 20 minutes).

[0067] In some embodiments, the pneumatic tube 103 is characterized by having measuring marks for measuring the distance from the posterior labial frenulum to the flexion point when the suction cup 102 is correctly positioned. These marks may indicate common flexion point intervals, such as 6 cm from the anterior occiput (OA) position, and 9 cm from the occiput transverse (OT) and posterior occiput (OP) positions. The marks may be printed along the entire circumference of the pneumatic tube 103 to ensure visibility regardless of rotation.

[0068] refer to Figure 2 The bottom surface of the shell 111A may include a muscle memory formation structure 172, which simulates the distance from the posterior fontanelle to the flexion point, typically 3 cm. This formation structure 172 allows the operator to practice diagnostic movements before starting surgery. The formation structure 172 presents the relative positions of the posterior fontanelle 172A, the sagittal suture 172B, and the flexion point 172C.

[0069] An exemplary method of using a fetal head vacuum aspirator 100 during vacuum-assisted delivery will be described below with reference to the accompanying drawings.

[0070] The clinician first places the suction cup 102 on the fetal head to help align it with the flexion point, thereby optimizing traction. To facilitate this alignment, the clinician can use a flexion point marker 164, positioned along the traction member 179, to indicate the distance from the flexion point. This ensures that the center of the suction cup 102 is correctly aligned with the flexion point of the fetal head. Once the suction cup 102 is correctly positioned, the clinician manually and repeatedly presses the proximal portion 110 and the distal portion 107 of the handle 101 to generate suction, while using the non-pressing hand to maintain the suction cup's position on the fetal head. The mechanical pump engages with the pneumatic tube 103 of the traction component 179 to generate suction within the suction cup 102, thereby securing it to the fetal head.

[0071] When the clinician pulls the handle 101 to apply traction, the traction member 179 transmits force to the fetus, assisting in correcting any abnormal fetal position and guiding the fetus through the birth canal. A force gauge 112, connected to the traction member, monitors the tension on the traction cord 120 and provides feedback. If the applied force exceeds a safe level, tactile protrusions 113 extend through the shoulder 109 of the handle, providing continuous tactile feedback to the clinician's fingers without visual confirmation. Tactile feedback from the force gauge 112 allows the clinician to adjust the applied force as needed, facilitating safe traction. The clinician can monitor the flexion point slider marker at any stage to track the fetal descent through the birth canal, enabling assessment of labor progress or stagnation and adjustments to surgical procedures to reduce the risks associated with labor stagnation. Furthermore, if the device includes a timer 168, the clinician can monitor the duration of the procedure and adhere to recommended time limits to reduce the risk of complications from prolonged use.

[0072] After necessary traction is applied and the fetus is safely delivered, the clinician releases the vacuum by activating the vacuum release mechanism 157. By pulling the trigger 158, the plunger 160 is disengaged from the vacuum seal, thereby releasing the suction in the suction cup 102 and allowing it to be safely removed from the fetal head.

[0073] This method ensures the controllability and safety of traction during labor: precise alignment and labor monitoring are achieved using the flexion point marker 164, the force application is monitored through tactile feedback from the force gauge 112, and the suction cup is safely removed with the help of the vacuum release mechanism 157.

[0074] For illustrative purposes, specific terminology has been used to provide a thorough understanding of the invention. However, it will be apparent to those skilled in the art that such detailed information is unnecessary for practicing the invention. Therefore, the foregoing description of specific embodiments of the invention has been provided for purposes of illustration and description. These descriptions are not intended to be exhaustive or to limit the invention to the precise forms disclosed, as it will be apparent that many modifications and variations can be made in light of the foregoing teachings. The selected and described embodiments are intended to explain the principles and practical application of the invention, and thus enable others skilled in the art to best utilize the invention and its various embodiments with various modifications suitable for the particular intended use. The following claims and their equivalents are intended to define the scope of the invention.

Claims

1. A tire head vacuum aspirator, comprising: Proximal handle; Distal suction cup; as well as Traction components, The distal suction cup is pulled from the proximal handle by the traction member to provide auxiliary traction during childbirth. The proximal handle includes a distal portion that reciprocates to receive the proximal portion and defines a neck that engages with the traction member. The shoulder area near the neck defines a gripping surface for the index finger to grasp. The distal and proximal portions are configured to be manually operated by repeated pressing to activate a mechanical pump between them. This mechanical pump connects to the pneumatic tube of the traction component, thereby generating suction within the suction cup. The proximal handle also includes a force gauge connected to the traction member and having a tactile protrusion. When the force applied by the traction member is sufficient to displace the force gauge, the tactile protrusion protrudes through the grip surface, thereby providing tactile force feedback to the opposite index finger.

2. The suction device according to claim 1, wherein, The force gauge includes a fork-shaped member having a pair of side rails connected to a pneumatic tube connector that pneumatically engages the pneumatic tube, wherein the force gauge provides tactile feedback when a force is sufficient to displace the pneumatic tube connector and the fork-shaped member.

3. The suction device of claim 1, further comprising a traction rope extending through the pneumatic tube, and wherein, The two ends of the traction rope are fixed by cup beads and force measuring beads, respectively.

4. The suction device according to claim 3, wherein, The traction rope is wound around the suction cup and the handle.

5. The suction device according to claim 3, wherein, The cup bead includes barbs configured to receive the traction rope for it to pass through and to achieve a pneumatic seal at the distal end of the pneumatic tube.

6. The suction device according to claim 3, wherein, The cup bead includes a distal retainer for engaging with the distal end of the traction rope.

7. The suction device according to claim 3, wherein, The force-measuring bead is completely held within the proximal end of the pneumatic tube.

8. The suction device according to claim 7, wherein, The force-measuring bead includes a joint portion for securing the traction rope, wherein the joint portion is shaped to interfere with the corresponding contour of the circumferential cylinder of the force gauge within the pneumatic tube, thereby transmitting traction force from the traction rope to the force gauge.

9. The suction device according to claim 7, wherein, The force-measuring bead includes an air channel support.

10. The suction device according to claim 8 further includes a compression spring that biases the cylinder in the proximal direction.

11. The suction device according to claim 7, wherein, The proximal portion of the pneumatic tube located between the force-measuring bead and the pump of the suction device is in a relaxed state, so that the force-measuring bead can move relative to the pump under the traction force.

12. The suction device of claim 1, further comprising a vacuum gauge operatively connected to the pump, wherein, The vacuum gauge includes an elongated bellows that is mechanically coupled to an indicator, wherein the elongated bellows is configured to contract longitudinally under working vacuum pressure, thereby displacing the indicator.

13. The suction device according to claim 12, wherein, The elongated bellows includes multiple pleats, the pitch of which is configured to allow the bellows to contract under the working vacuum pressure.

14. The suction device of claim 1, further comprising a vacuum gauge operatively connected to the pump, wherein, The markings on the handle are aligned with the markings on the pump under operating vacuum pressure.

15. The suction device according to claim 1, wherein, The mechanical pump includes a manifold that is pneumatically connected to the cylinder block of the proximal portion.

16. The suction device according to claim 15, wherein, The proximal portion is biased by a compression spring along the proximal direction.

17. The suction device according to claim 15, wherein, The manifold is connected to the exhaust valve and the intake valve.

18. The suction device according to claim 17, wherein, The intake valve is a diaphragm valve, which is sealed against a radially offset outlet port.

19. The suction device according to claim 18, wherein, One of the outlet ports is connected to the pneumatic tube.

20. The suction device according to claim 18, wherein, One of the outlet ports is connected to the vacuum release mechanism.

21. The suction device according to claim 18, wherein, One of the lead-out ports is connected to the vacuum gauge.

22. The suction device according to claim 1, further comprising a vacuum release mechanism, the vacuum release mechanism including a trigger.

23. The suction device according to claim 22, wherein, The trigger is operable in the distal direction.

24. The suction device according to claim 22, wherein, The vacuum release mechanism includes a pneumatically sealed plunger, wherein the trigger engages the plunger to release the pneumatic seal of the plunger.

25. The suction device according to claim 24, wherein, The vacuum release mechanism includes a stroke delay coupling that engages the trigger and the plunger, wherein the plunger is displaced only after the trigger has traveled beyond a distance threshold.

26. The suction device according to claim 22, wherein, The trigger includes a biasing mechanism for resetting the trigger.

27. The suction device according to claim 26, wherein, The biasing mechanism includes a hinged compression spring.

28. The suction device according to claim 22, wherein, The trigger is exposed at the neck of the handle.

29. The suction device according to claim 1, wherein, The bottom surface of the shell includes muscle memory formation structures that indicate the position of the flexion point.

30. The suction device according to claim 29, wherein, The length of the muscle memory formation structure is approximately 3 cm, which represents the distance from the posterior fontanelle along the sagittal suture to the flexion point.

31. A method of using the fetal head vacuum aspirator according to claim 1, comprising: Position the suction cup on the fetal head; Manually and repeatedly press the proximal and distal portions of the handle to create a vacuum inside the suction cup through the pneumatic tube; as well as The traction member applies traction to assist delivery, wherein the tactile protrusion of the force gauge provides tactile force feedback to indicate the applied tension without visual monitoring.

32. The method of claim 31, further comprising: The distance between the flexion point marker on the traction member and the flexion point on the fetal head is indicated by the flexion point marker, so that the center of the suction cup is aligned with the flexion point.

33. The method of claim 31, further comprising: The descent point marker on the traction member is used to indicate the progress of traction.

34. The method according to claim 31, wherein, The force gauge includes a fork-shaped component and a pneumatic tube connector, and the application of traction further includes receiving tactile feedback when the fork-shaped component of the force gauge is displaced from the pneumatic tube connector, indicating that a predetermined force threshold has been reached.

35. The method of claim 31, further comprising: The vacuum is released by operating a vacuum release mechanism including a trigger, wherein the trigger engages with a plunger, thereby releasing the pneumatic seal of the plunger to release the vacuum within the suction cup.

36. The method of claim 35, further comprising: Pushing the trigger beyond the travel delay threshold ensures that the vacuum can be intentionally released, thereby preventing accidental vacuum release during operation.

37. The method of claim 31, further comprising: Observe the vacuum gauge, which includes a slender bellows that mates with an indicator. The slender bellows contracts longitudinally under working vacuum pressure, thereby shifting the indicator and allowing visual confirmation that sufficient vacuum pressure has been reached.

38. The method according to claim 31, wherein, The suction device includes a vacuum gauge, the vacuum gauge includes markings on the handle and markings on the pump, and the method further includes aligning the markings before applying traction to confirm that the working vacuum pressure has been reached.

39. The method of claim 35, further comprising: After the vacuum is released, the trigger is reset by means of a biasing mechanism including a hinged compression spring.

40. The method according to claim 31, wherein, The application of traction further includes: using a traction rope extending through the pneumatic tube, wherein the traction rope is fixed by cup beads and force measuring beads located at both ends of the traction member, thereby transmitting the traction force from the handle to the suction cup.

41. The method of claim 31, further comprising: A core timer is used to monitor the duration of vacuum-assisted delivery, thus providing a visual indication of the elapsed time.

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