WO2002088546A1

WO2002088546A1 - Obstetrical vacuum extractor cup and pump

Info

Publication number: WO2002088546A1
Application number: PCT/US2002/012894
Authority: WO
Inventors: Dan Dimitriu
Original assignee: Prism Enterprises, Lp
Priority date: 2001-04-27
Filing date: 2002-04-24
Publication date: 2002-11-07

Abstract

An obstetrical vacuum extractor (20) and coupled hand-held pump arrangement wherein the pump subassembly (22) includes a diaphragm (94) deflectable to draw a vacuum through an inlet valve (102) to draw a vacuum within the extractor cup (126). A handle (134) biased in a first position by plastic springs (144) may be moved to a second position to deflect the diaphragm (94). A relief valve (64) including an opening (70) covered by an elastically deformable elastomeric band (72) may be selectively actuated to fluidly couple the interior of the cup (26) to the atmosphere. The assembly extractor (20) may be assembled into a shell (50) and may include a pressure gauge (82) and/or a timer (90).

Description

OBSTETRICAL VACUUM EXTRACTOR CUP AND PUMP

FIELD OF THE INVENTION

[0001] The present invention relates to an apparatus for facilitating the delivery of a child during childbirth, and more specifically relates to a combination vacuum extractor and pump for use during childbirth.

BACKGROUND OF THE INVENTION

[0002] During childbirth, the birth mother is sometimes unable to deliver the child without assistance. In some cases, all that is required is for a nurse, midwife, or attending physician to push down on the birth mother's upper abdomen when she bears down during delivery. In other cases, it is necessary for a physician to perform a Caesarean section. For those cases between the two extremes, some sort of intermediate assistance is often required. Such intermediate assistance generally entails the use of a device to aid in the delivery of the child. These devices may likewise be required to assist a physician during particularly difficult Caesarean sections.

[0003] One example of such a device is forceps. Forceps, however, tend to be bulky and difficult to operate. In addition, the use of forceps, at the very least, is uncomfortable for the mother and infant and risks injury to both.

[0004] Alternative devices to forceps are obstetrical vacuum extractors. Conventional obstetrical vacuum extractor systems utilize a cup, which may be placed onto the child's head, an elongated traction device with a handle for applying the traction force, and, traditionally, an elongated tube coupled at one end to the interior of the cup and the other end to a hand-held pump. Operation of the hand-held pump results in the development of a vacuum between the cup and the infant's head, which is then used to maneuver and extract the infant from the birth canal by pulling in an appropriate direction on the gripping device. The tube may be coupled directly to the cup or coupled to an elongated hollow stem which acts as the tractioning device. Other tractioning devices may be in the form of a cord, a chain, or the like. The gripping device may be in the form of a handle, or a loop in a cord or the like. [0005] More recently, unitary obstetrical vacuum extractor devices have been developed which include a vacuum extractor cup integrated with a hand-held pump and pulling handle. In this way, once properly placed on the infant's head, the physician can both apply an extraction force and maneuver the cup while applying and maintaining a vacuum within the cup, all with the same hand. Such devices are disclosed in, for example, U.S. Patent 5,395,379 to Deutchman et al., and U.S. Patent 6,074,399 to Wallace et al.

[0006] During use, it is imperative that the physician be provided with an accurate monitor of the forces exerted on the infant's head. In this regard, it is critical that the physician be aware of the level of vacuum pressure applied to the infant's head, to ensure that both adequate vacuum pressure is maintained to permit the application of a traction force and to minimize the possibility of injury to either the infant or the mother. Moreover, inasmuch as accepted techniques limit the length of time that a vacuum force is applied to the infant's head, it is desirable for the physician to monitor the length of time that the vacuum is applied.

[0007] Unfortunately, neither the Deutchman device nor the Wallace device themselves provide the physician with direct feedback regarding the time passage. Moreover, while they both provide for monitoring of the pressure level, the visibility of the pressure gauge disclosed in the Deutchman and Wallace devices may be limited in that they are disposed along one side of the assembly. While the commercial embodiment of the Wallace device includes a slidably mounted pressure gauge which telescopes from one end of the handle, the telescoping pressure gauge is relatively shaφ and may cause damage to surrounding maternal tissue. Further, the telescoping gauge may be readily damaged as the relatively long, yet small cross-section gauge cantilevers from the end of the handle when the required vacuum extraction pressure is applied.

BRIEF SUMMARY OF THE INVENTION

[0008] Accordingly, it is an object of the invention to provide a low cost, reliable unitary pump and vacuum extractor cup combination. More specifically, it is an object of the invention to provide a vacuum extractor assembly having a pump and cup which are modular and can be readily and reliably assembled onto a shell which provides structure to the assembly.

[0009] It is another object of the invention to provide a pump assembly that provides the physician with superior control of the level of vacuum applied. It is a related object to provide a pump assembly which draws a direct vacuum from the vacuum cup upon actuation.

[0010] It is a further object of the invention to provide a vacuum cup assembly which may be operated by the physician using one hand.

[0011] Another object of the invention is to provide a vacuum cup assembly which utilizes low cost plastic springs as an integral part of the pump design. [0012] An additional object of the invention is to provide a vacuum cup assembly which provides direct feedback to the physician regarding the applied vacuum as well as the time period for which such vacuum is applied. A related object is to provide the physician with a superior view of the displays of the pressure level and time lapsed. [0013] Yet another object of the invention is to provide a vacuum cup assembly which utilizes a diaphragm-type pump which minimizes the opportunity for damage to the seals within the pump, as opposed to a piston-type pump which utilizes a telescoping piston and requires the placement of seals between moving parts.

[0014] In accomplishing these and other objectives of the invention, there is provided an obstetrical vacuum cup assembly which includes a vacuum cup with a hand-held vacuum pump coupled directly thereto such that the assembly may be maneuvered and a vacuum applied by a single hand of the physician. The cup and pump components are assembled onto a shell which comprises a base portion into which the components of the cup subassembly are assembled and a loop portion. A handle is disposed within the loop portion such that the user may squeeze the handle and loop portion together to actuate the pump.

[0015] The pump portion preferably comprises a diaphragm arrangement having a diaphragm which is flexed outward to an inverted position to draw a vacuum through a valve from the interior of the vacuum cup as the handle and loop portion are squeezed together. The valve is preferably a combination valve having a one-way duckbill valve extending into the interior chamber of the pump. The physician establishes the necessary vacuum within the cup by sequentially squeezing and releasing the handle to the loop portion. As the physician releases the handle portion, plastic springs, which are preferably integrally formed with the handle, restore the handle to its biased downward position. As the handle is restored, the diaphragm returns to its uninverted position and air contained within the pump chamber is expelled through openings past a base portion of the combination valve.

[0016] The device preferably includes a relief valve which may be readily actuated by an outward extension of the physician's finger. The relief valve includes an opening into a channel in communication with the interior of the vacuum cup and a valve preferably in the form of an elastomeric band which is disposed over the opening. The band is flexed away from the relief valve opening by a cantilevered arm which may be actuated by the physician's index finger, even when the physician's hand is on the handle. In this way, the physician may continue pulling while readily adjusting the vacuum within the vacuum cup. [0017] The obstetrical vacuum extractor assembly preferably further includes a pressure gauge which is in communication with the interior of the cup such that it displays the vacuum pressure developed within the cup. The pressure gauge is advantageously rotatably mounted so that the physician may rotate the gauge such that the physician may aim the pressure gauge display toward his line of sight. The vacuum assembly further preferably includes a timer positioned such that the physician may also readily reach the timer activation buttons. In this way, the physician may activate the timer with a thumb of the physician's hand in position on the handle to obtain an accurate measurement of the time period for which a vacuum has been applied, for example. Accordingly, the disclosed obstetrical vacuum extractor device provides a convenient, obstetrical vacuum extraction device which may be operated with one hand and readily monitored by the physician.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIGURE 1 is a front perspective view of an obstetrical vacuum extractor assembly according to teachings of the invention and incoφorating a bell-shaped cup. [0019] FIG. 2 is a front cross-sectional view of an obstetrical vacuum extractor assembly similar to the assembly of FIG. 1, but incoφorating a mushroom-shaped cup and a timing device. [0020] FIG. 3 is an enlarged fragmentary front elevational view of the pump assembly of FIGS. 1 and 2 wherein one-half of the shell is removed.

[0021] FIG. 4 is an enlarged front elevational view of the opposite half of the shell assembly removed from FIG. 3.

[0022] FIG. 5 is a perspective view of the cup assembly of FIG. 1. [0023] FIG. 6 is an enlarged perspective view of the cone, valve, diaphragm subassembly of the pump of FIGS. 1-3.

[0024] FIG. 7 is an enlarged cross-sectional view of the subassembly of FIG. 6. [0025] FIG. 8 is an enlarged perspective view of the valve shown in FIGS. 3, 6 and 7. [0026] FIG. 9 is an enlarged front elevational view of the core and handle assembly of FIGS. 1-3.

[0027] FIG. 10 is an enlarged side view of the core of FIG. 8. [0028] FIG. 11 is an enlarged perspective view of the handle of FIG. 8.

DETAILED DESCRIPTION OF THE INVENTION

[0029] Turning now to FIG. 1 , there is shown an obstetrical vacuum extractor assembly 20 constructed in accordance with teaching of the invention. The obstetrical vacuum extractor assembly includes a pump subassembly 22 and a vacuum cup subassembly 24. The vacuum extractor cup subassembly 24 comprises a hollow vacuum cup 26 having a back wall or base 28 and an annular side wall 30 which opens into a basal opening 32 for placement against the head of a child. In the embodiment illustrated in FIG. 1, the vacuum cup 26 is in the general shape of a bell. It will be appreciated, however, that the vacuum cup 26 may be of an alternate design. For example, the hollow vacuum cup 26a may be in the general shape of a mushroom or bowl, as shown in FIG. 2. (It will be noted that like components in FIG. 2 will be designated with the letter "a" following the reference number.)

[0030] The vacuum extractor cup subassembly further includes a shaft or tube 34 defining a hollow passageway 36 which opens into the inside of the cup 26. (See FIG. 2.) It will be noted that in the embodiments of the invention illustrated the shaft is a relatively rigid structure. It will be appreciated, however, that the hollow shaft or tube 34 may alternately be a relatively flexible tube. The opposite end of the hollow shaft or tube 34 is coupled to the pump subassembly 22 such that the pump may develop a suitable vacuum or lower pressure within the cup 26 when the cup 26 is placed on the head of an infant during delivery (not shown). In order to distribute the vacuum, and prohibit the passage of large debris, the cup is provided with a disk 38 having a plurality of openings 40 therethrough. The disk 38 may be spaced from the back wall 28 of the vacuum cup 26 by a plurality of ribs 42, preferably extending radially along the inside surface. In order to prevent further passage of fluid and small debris, the vacuum cup 26 may be provided with an additional filter. In the preferred embodiment, a small disk-shaped foam filter is provided in a small annular cavity 44 formed by the ribs 42 at the base of the shaft 34. The foam filter is preferably formed of polypropylene or the like. It will be appreciated, however, that an alternate filter may be provided or may be alternately placed within the obstetrical vacuum extractor cup assembly 20, such as in the stem 34. The disk 38 may be coupled to the cup by any appropriate means such as gluing or ultrasonic welding or the like to secure the foam filter in position at the base of the stem. [0031] In accordance with the invention, the pump subassembly 22 and vacuum extractor cup subassembly 24 are supported on a shell or frame 50 such that the obstetrical vacuum extractor assembly 20 is of a modular design. In this way, the individual components may be readily fabricated separately and then assembled into the shell to form the assembly 20. For example, any vacuum extractor cup subassembly 24 presenting the required cooperative structure may be utilized in the shell 50 as, for example, shown in the embodiments of FIGS. 1 and 2. The two halves 50a, 50b of the shell 50, which are illustrated in FIGS. 3 and 4, respectively, include a plurality of recesses for receiving components of the pump subassembly 22 and the cup subassembly to couple the subassemblies 22, 24 thereto. In order to permit coupling of the shell halves 50a, 50b, the shell halves 50a, 50b are provided with a plurality of pins and bores for receiving such pins 52. The shell 50 further includes a base portion 55 and a loop portion 56, the significance of which will be explained subsequently. While the shell 50 is preferably formed of a relatively rigid material, such as ABS, other materials are likewise appropriate. [0032] In order to couple the vacuum extractor cup subassembly 24 to the shell 50, the vacuum extractor cup subassembly 24 further comprises a coupling structure 58 disposed at its upper end which both couples the cup subassembly 24 to the shell 50 and facilitates sealing to the pump subassembly 22. To assist in sealing the shaft 34 to the pump subassembly 22, the coupling structure 58 includes a hollow vertical shaft portion 60 having an axially extending cylindrical flange 61 which engages components of the pump subassembly 22. In order to secure the position of the vacuum extractor cup subassembly 24 within the shell 50, the coupling structure 58 is further preferably provided with at least one collar 62. In the preferred embodiment, two such collars 62 are provided. [0033] To provide the physician with immediate control of the vacuum level within the cup 26, a vacuum relief valve 64 is also provided. The vacuum relief valve 64 comprises a substantially horizontal segment 66 having a hollow interior 68 in fluid communication with the passageway 36 of the hollow shaft 34. A relief opening 70 in a protrusion 71 is in fluid communication with the hollow interior 68 of the horizontal segment 66, and, therefore, the passageway 36 of the hollow shaft 34 and the interior of the cup 26. A valve in the form of an elastomeric band 72 is disposed about the horizontal segment 66 covering the relief opening 70. In this way, the elastomeric band 72 may be spaced outward from the relief opening 70 in order to provide ambient air through the opening 70, hollow interior 68 and passageway 36 into the interior above the cup 26 to relieve the vacuum. [0034] Movement of the elastomeric band 72 from the relief opening 70 is provided by means of a relief lever 74 cantilevered from one of the collars 62. The relief lever 74 includes a hook 75 which extends about the protrusion 71 and through the elastomeric band 72. In this way, when the relief lever 74 is flexed downward, the hook 75 moves the band 72 away from the opening 70, allowing an equalization of pressures between the atmosphere and the interior of the vacuum cup 26. It will be appreciated that the relief lever 74 is normally biased to the position shown in FIGS. 2, 3 and 5. [0035] During use, the physician moves the relief lever 74 out of bias by pushing one of the buttons 76 coupled to the relief lever 74 downward within the slot 78 extending through the shell halves 50a, 50b. When the physician releases the downward force by removing his finger from the button 76, the relief lever 74 is restored to its original position allowing the elastomeric band 72 to return to its natural state covering the relief opening 70. It will be appreciated that other designs of relief valves or actuation mechanisms may be utilized, but the design shown is particularly useful in that the physician may easily relieve some or all of the vacuum within the cup 26 by merely applying a slight force to the button 76 with a finger from the physician's hand holding the pump subassembly 22. [0036] In order to provide the physician with concurrent information regarding the pressures developed within the cup 26, a pressure gauge 82 is provided on one side of the shell 50. The pressure gauge 82 includes a sleeve 83 having annular channels 84 extending about its circumference. In use, the sleeve 83 is disposed within the recesses 86 in the shell halves 50a, 50b and a bore 86a in the horizontal segment 66 in communication with the hollow interior 68 when assembled. To secure the pressure gauge 82 within the recesses 86, a C-shaped locking component or other lock washer 88 is disposed within one of the annular channels 84a. To ensure a good seal of the pressure gauge 82 in communication with the bore 86a and hollow interior 68 of the horizontal segment 66, an O-ring 89 or other sealing material is disposed within the second of the annular channels 84b. According to another important feature of the invention and as will be appreciated by those of skill in the art, the pressure gauge 82 is rotatable within the recess 86 so that the physician may rotate the pressure gauge to the most desirable position for viewing during delivery.

[0037] According to another important feature of the invention, the obstetrical vacuum extractor assembly 20 may be provided with a timer 90 (see FIG. 2). The timer 90 may be of any appropriate or desirable design, and preferably includes one or more buttons 91 for activating, pausing, reactivating, and resetting the timer. The timer may also include features which allow the physician time individual cycles of use of the extractor assembly 20, and periods of rest, as well as the total lapsed time for application of the vacuum. The timer may be of any known design, so long as it is positioned such that it is readily actuated by the physician's hand holding the pump subassembly 22 and easily viewed by the physician preferably without removing the hand from the pump handle. [0038] Turning now to the construction of the pump subassembly 22, the pump components may best be viewed in FIGS. 2, 3, and 6-8. The vacuum is created by movement of a diaphragm 94 relative to a cooperating cone or base 96 which form a pump chamber 97 therebetween. The cone 96 includes a central bore 98 and a plurality of openings 100 through which the vacuum is drawn and the air drawn into the pump chamber 97 is expelled, respectively. To this end, a combination valve is 102 provided as illustrated in FIG. 8. The valve 102 includes a cup shaped base portion 104 which is disposed over the openings 100 of the cone 96 and an extension 106 which protrudes upwards through the central bore 98 of the cone 96, as best seen in FIG. 7. The combination valve 102 further includes a channel 110 extending upward through the extension 106 and in communication with a slit opening 112, which is best seen in FIG. 8. As best seen in FIG. 2, the axially extending annular flange 61 of the vacuum extractor cup subassembly 24 extends upward into and in sealing engagement with the channel 110. To secure the combination valve 102 in position on the cone 96, an annular lip 108 and an annular abutment 108a are provided along an outer surface of the combination valve 102 such that the annular lip 108 and the annular abutment 108a are disposed above and below the surfaces of the cone 96, respectively, when assembled as shown in FIG. 7. [0039] During use, the diaphragm 94 is flexed upward to an inverted position to develop a volume in the pump chamber 97. As the diaphragm 94 flexes upward, air is drawn from the interior of the cup 26 through the passageway 36 and through the slit opening 112 of the combination valve 102. It will be appreciated by those of skill in the art that the slit opening 112 provides a one-way flow of air from the cup into the pump chamber 97. As the diaphragm 94 is restored to its original position illustrated in FIGS. 2 and 7, the air contained within the pump chamber 97 is expelled through the plurality of openings 100, separating the base portion 104 of the combination valve 102 slightly from the lower surface of the cone 96 to allow the escape of air. Inasmuch as the shell 50 itself is not sealed, the expelled air may then escape through, for example, the slots 78. [0040] In order to further seal the pump chamber 97 and facilitate the upward flexing of the diaphragm 94, a core 120 (as best seen in FIGS. 2 and 10) is provided. The core 120 includes a base portion 122 which generally conforms to the dimensions of the pump chamber 97 between the diaphragm 94 and the cone 96 when the diaphragm 94 is in an unflexed, uninverted position. The base portion 122 includes annular flat surfaces 124, 126 which are disposed subjacent surfaces of the diaphragm and an annular radially extending flange 128 which is disposed above an upper surface of the diaphragm 94 when assembled, as shown in FIG. 2. To further secure the core 120 to the diaphragm 94, an O- ring 130 is disposed about an upper surface of the diaphragm 94. The O-ring 130 and the core 120 are preferably of a relatively firm material, such as a polyethylene or polypropylene, while the diaphragm 94 is formed of a relatively more pliant material, such as a silasic or an elastomeric material. The currently preferred material for the diaphragm 94 is a Kraton material

[0041] To facilitate the upward movement of the core 120 to actuate and invert the diaphragm 94, a handle assembly 132 is provided. The handle assembly 132 includes a handle 134 preferably having a lower surface 136 which generally conforms to the physician's fingers and provides a comfortable, ergonomic design. To couple the core 120 to the handle 134, any appropriate design may be utilized. In the preferred design, the core 120 includes a T-shaped upper portion 138 having radially extending flanges 140. The radially extending flanges 140 are received in and cradled by a pair of slings 142, as may be seen in FIGS. 1 and 3. As shown in FIG. 9, during assembly, the T-shaped upper portion 138 is slid upward between the slings 142. The core 120 is then rotated and moved downward to cradle the flanges 140 in the slings 142. Thus, as the handle 134 is advanced upward within the shell 50, the slings 142 and the core 120 move upward to flex the diaphragm 124 outward to an inverted position, drawing a direct vacuum from the cup 26 through the opening 112 into the pump chamber 97.

[0042] To provide a restorative force to the handle 134, allowing the diaphragm 94 to return to its original position, springs 144 are provided at either end of the handle 134. According to an important feature of the invention, the springs 144 are formed unitarily with the handle of a plastic material. Preferably, the handle 134 and springs 144 are formed of a polypropylene material, although other materials are within the purview of the invention as will be appreciated by those with skill in the art.

[0043] Although the axially extending channel flange 61 of the shaft 34 of the cup subassembly 24 seals to the channel 110 of the valve 102, to further directly couple the pump subassembly 22 to the cup subassembly 24 (see FIGS. 6 and 7), the cone 96 includes two pairs of downwardly extending claws 146 defining a cylindrical opening 148 therethrough. As may be seen in FIG. 3, the claws 146 are disposed about the horizontal segment 66 of the vacuum extractor cup subassembly 24 to secure the subassemblies 22, 24 together before placement in the shell 50.

[0044] The entire pump subassembly is received in various recesses 150 in the shell halves 50a, 50b, which preferably conform to the contours of the pump subassembly 22 (and cup subassembly 24) components. It will be appreciated that the pump subassembly 22 components may include additional structure which is specifically designed to engage conforming recesses in the shell 50 to further couple the components to the shell 50 and ensure that the relative positions are securely maintained during use of the device. Protrusions 152 extending from the side surfaces of the claws 146 are examples of such structure.

[0045] As may best be seen in FIGS. 2 and 3, the distal end 156 of the springs 144 of the handle 134 preferably include loop portions 135 which similarly engage sleeves 170 or pins 172 in the shell halves 50a, 50b. Thus, the loop portions 135 and therefore the springs 144 are free to rotate as the handle 134 is squeezed upward during actuation of the pump subassembly 22. Preferably, the shell halves 50a, 50b also form a pair of channels 160 which cradle the outer surfaces 162 of the handle 134 to guide the movement of the handle 134 as the pump subassembly 22 is actuated.

[0046] Preferably, the upper surface 164 of the handle 136 conforms to an inner surface 166 of the loop portion 56. During use, the physician compresses the handle 134 to the loop portion 56 to draw a vacuum in the interior of the hollow vacuum cup 26. During use, the physician may maintain the handle 134 and loop portion 56 in adjacent positions with the diaphragm 94 flexed into the inverted, outward position, or the physician may allow the springs 144 to return the handle to its downwardly biased position shown in FIG. 2. While the physician may apply a traction force by grasping the inner surface 166 of the loop portion 56, a traction force is preferably applied with the physician's hand subjacent the handle 134. In this way, the physician applies a traction force by exerting a force along the lower surface 134 of the handle 134.

[0047] In summary, the invention provides a compact, convenient extractor assembly 20, wherein the physician may control the usage of the assembly 20 entirely with one hand, leaving the other hand free for other functions. The device provides the physician with all necessary information for providing a safe application of the vacuum extractor during the delivery process.

Claims

I claim as my invention:

1. A hand held pump comprising: a base having an inlet, a diaphragm disposed in a sealing relationship with said base, said diaphragm being moveable between a first position and a second position, said base and said diaphragm defining a pump chamber therebetween, a handle coupled to the diaphragm, said diaphragm being operable to move the diaphragm between said first and second positions, said handle and said diaphragm being biased in said first position, an inlet, a one-way inlet valve through which gas or fluid may be drawn into said pump chamber, an outlet, a one-way outlet valve through which gas or fluid may be exhausted from said pump chamber, whereby at least one of movement of the diaphragm from the first to the second position or movement of the diaphragm from the second to the first position results in a draw of gas or fluid through the one way inlet valve.

2. The hand-held pump of claim 1 wherein the handle is biased in the first position by springs.

3. The hand-held pump of claim 2 wherein the springs are plastic, and are integrally formed with at least a portion of the handle.

4. The hand-held pump of claim 1 wherein movement of the diaphragm from the first position to the second position causes said gas or fluid to be drawn through the inlet valve.

5. The hand-held pump of claim 1 wherein the first position of the diaphragm is a free state, and the second position of the diaphragm is an inverted position.

6. The hand-held pump of claim 1 wherein the handle includes a moveable portion and a looped portion, the moveable portion being moveable toward the looped portion during use to move the diaphragm between the first and second positions.

7. The hand-held pump of claim 1 further comprising a shell having at least one recess, at least a portion of said diaphragm and said base being disposed within said recess.

8. The hand-held pump of claim 7 further comprising at least one spring coupled to said handle, said spring being coupled to said at least one recess in said shell.

9. The hand-held pump of claim 1 further comprising a relief valve.

10. The hand-held pump of claim 7 further comprising a selectively actuable relief valve, at least a portion of said relief valve being disposed in said at least one recess in said shell.

11. The hand-held pump of claim 10 wherein the relief valve includes a relief opening, a covering over said opening, and a cantilevered relief lever disposed to move said covering away from engagement with said opening.

12. The hand-held pump of claim 1 further comprising an obstetrical vacuum extractor cup subassembly, said obstetrical vacuum extractor cup assembly comprising a hollow cup having a basal opening, and a hollow passageway opening into the hollow interior, said hollow passageway being fluidly coupled to the inlet.

13. The hand-held pump of claim 1 comprising a combination inlet and outlet valve arrangement, said combination inlet and outlet valves being a combination duckbill and umbrella valve.

14. The hand-held pump of claim 12 further comprising a vacuum gauge in fluid communication with the hollow interior of the cup.

15. An obstetrical vacuum extractor assembly for use during childbirth, said assembly comprising: an obstetrical vacuum extractor subassembly comprising a obstetrical vacuum extractor cup having a hollow interior and defining a basal opening, and a hollow passageway opening into the hollow interior, a pump subassembly fluidly coupled to said hollow passageway, said pump comprising a handle moveable between a first position and a second position, said handle being biased in said first position by at least one plastic spring.

16. The obstetrical vacuum extractor assembly of claim 15 wherein the handle and the at least one plastic spring are integrally molded.

17. An obstetrical vacuum extractor assembly for use during childbirth, said assembly comprising: an obstetrical vacuum extractor subassembly comprising a obstetrical vacuum extractor cup having a hollow interior and defining a basal opening, and a hollow passageway opening into the hollow interior, a pump subassembly comprising an inlet, an outlet, a vacuum chamber and a selectively actuable pump mechanism for drawing a vacuum through the inlet and exhausting said vacuum through the outlet, and a shell comprising a plurality of recesses for receiving at least a portion of the obstetrical vacuum extractor subassembly and the pump subassembly to couple said subassemblies in fixed relation.

18. The obstetrical vacuum extractor assembly of claim 17 wherein the extractor comprises a coupling structure adapted for disposal in at least one of said plurality of recesses.

19. The obstetrical vacuum extractor assembly of claim 18 wherein said hollow passageway comprises a longitudinal axis, and said coupling structure comprises at least one collar extending at an angle from said longitudinal axis.

20. The obstetrical vacuum extractor assembly of claim 19 wherein said hollow passageway comprises an elongated hollow shaft.

21. The obstetrical vacuum extractor assembly of claim 19 wherein said hollow passageway comprises an elongated flexible tube.

22. The obstetrical vacuum extractor assembly of claim 17 wherein the obstetrical vacuum extractor subassembly and the pump subassembly comprise engageable structure to couple the subassemblies prior to placement in the shell.

23. The obstetrical vacuum extractor assembly of claim 17 wherein the shell comprises at least two portions adapted to be secured together about said at least a portion of the obstetrical vacuum extractor subassembly and the pump subassembly.

24. The obstetrical vacuum extractor assembly of claim 23 wherein the at least two portions comprise engageable structure that secures the at least two portions together.

25. The obstetrical vacuum exfractor assembly of claim 17 wherein the shell comprises a base portion and a loop portion, said at least a portion of the obstetrical vacuum extractor subassembly and the pump subassembly being disposed in said base portion.

26. The obstetrical vacuum extractor assembly of claim 17 further comprising a selectively actuable relief valve whereby said vacuum within the cup may be released.

27. The obstetrical vacuum extractor assembly of claim 17 further comprising a pressure gauge, and said shell further comprising a pressure gauge recess, at least a portion said pressure gauge being disposed in said pressure gauge recess.

28. The obstetrical vacuum extractor assembly of claim 27 wherein the pressure gauge is rotatably disposed in said pressure gauge recess.

29. The obstetrical vacuum extractor assembly of claim 17 further comprising a timer, said timer being coupled to said shell.

30. An obstetrical vacuum extractor assembly for use during childbirth, said assembly comprising: a obstetrical vacuum extractor cup having a hollow interior and defining a basal opening, and a hollow passageway opening into the hollow interior, a pump subassembly comprising an inlet fluidly coupled to the hollow passageway, an outlet, a vacuum chamber and a selectively actuable pump mechanism for drawing a vacuum through the inlet and exhausting said vacuum through the outlet, a selectively actuable relief valve for fluidly coupling the hollowing interior of the cup to the atmosphere, said relief valve comprising a valve body, relief valve opening into said body, an elastomeric band covering said valve opening whereby elastically deforming said elastomeric band to uncover said valve opening fluidly couples the interior of the cup to the atmosphere.

31. The obstetrical vacuum extractor assembly of claim 30 wherein the relief valve further comprises a moveable relief lever disposed to move said elastomeric band from said relief valve opening.

32. The obstetrical vacuum extractor assembly of claim 31 wherein the elastomeric band extends about at least a portion of the valve body and a portion of the moveable relief lever.

33. The obstetrical vacuum extractor assembly of claim 32 further comprising an actuator coupled to the relief lever, said actuator being actuable to move the relief lever to cause the elastomeric band to uncover the relief valve opening.

34. An obstetrical vacuum extractor assembly for use during childbirth, said assembly comprising: a obstetrical vacuum extractor cup having a hollow interior and defining a basal opening, and a hollow passageway opening into the hollow interior, a pump subassembly comprising an inlet fluidly coupled to the hollow passageway, an outlet, a vacuum chamber and a selectively actuable pump mechanism for drawing a vacuum through the inlet and exhausting said vacuum through the outlet, a pressure gauge fluidly coupled to the hollow interior of the cup, said pressure gauge being rotatably mounted to said pump subassembly.

35. The obstetrical vacuum extractor assembly of claim 34 wherein the pump subassembly further comprises an annular recess, said pressure gauge comprising a cylindrical stem, said stem being rotatably disposed in said annular recess.

36. The obstetrical vacuum extractor assembly of claim 35 further comprising a locking component, wherein the pump assembly further comprises an opening extending substantially radially from the annular recess, and wherein the stem comprises an annular channel extending about an outer surface thereof, said locking component being disposed about said stem within said radially extending opening.

37. The obstetrical vacuum extractor assembly of claim 34 further comprising a timer.

38. An obstetrical vacuum extractor assembly for use during childbirth, said assembly comprising: a obstetrical vacuum extractor cup having a hollow interior and defining a basal opening, and a hollow passageway opening into the hollow interior, a pump subassembly comprising an inlet fluidly coupled to the hollow passageway, an outlet, a vacuum chamber and a selectively actuable pump mechanism for drawing a vacuum through the inlet and exhausting said vacuum through the outlet, a timer.

39. The obstetrical vacuum extractor assembly of claim 38 wherein the timer tively actuable.