IE48100B1 - Fetal monitoring apparatus - Google Patents

Description

The invention relates to a fetal monitoring apparatus for use in attaching a coil, for example a coil electrode to the skin of a fetus during labour.

For over seventy years monitoring of fetal heart rate has been one of the important procedures in the management of labour. Recently, a number of electronic techniques have been developed for continuous recording of this data. Currently, the most successful techniques for fetal heart rate monitoring employ electrodes attached directly to the fetus.

US—E— 28,990 is directed to an electrode structure which ie believed to be the most effective type employed today in the monitoring of fetal heart rate. The state of the art prior to the development of the device disclosed in that patent is amply illustrated in the references cited during the prosecution of the application for that patent and those described in Column 1 of the patent.

US-E- 28,990 disoloses an apparatus for use in monitoring fetal heartbeat and the like uhich comprises a guide tube adapted to be inserted through the vagina and cervix of a woman in labour, a holder member slidably and rotatably disposed in the guide tube, a retaining coil mounted on the holder member and adapted to be screwed into a fetal epidermis by rotating the holder member. The holder member is rotated by means’ of a flexible drive tube slidably and rotatably disposed in the guide tube. The flexible drive tube is rotated manually by the doctor while holding the guide tube in position.

The present invention represents an improvement over the invention of US-E- 28,990 as will be appreciated from the following, description. Although the apparatus of the present invention is primarily intended for use in inserting a bipolar electrode structure through the vagina and cervix of a woman in labour and attaching it to the.epidermis of a fetus for monitoring of fetal - 3 heart rate it is contemplated that the apparatus of the invention can be used for attachment of a coil to a fetus for monitoring of any other parameters uhich require to be measured. Uhen used for monitoring fetal heart rate the electrode structure of the apparatus uill be operatively connected to an amplifier and a cardiotachometer far recording the fetal electrocardiogram and heart rate during labour and delivery.

The invention provides a fetal monitoring apparatus comprising a tubular member having a forward end adapted to be inserted though the vagina and cervix of a uoman in labour, a coil movably mounted in the tubular member, the coil being adapted to be attached to the skin of a fetus, characterised in that the apparatus includes converter means uhereby an applied linear force can be converted to rotary force to turn said coil.

Preferably the coil is mounted on a coil-carrying member and extends foruardly therefrom and the apparatus includes plunger means, the said converter means being adapted to translate linear force applied to the plunger means to rotary force applied to the coil carrying member.

The converter means may comprise a generally helical groove and projection means engaging uith said groove.

The groove may be disposed on one of the coilcarrying membersor the tubular member and the projection means is disposed on the other of the coil carrying members or the tubular member.

In one embodiment the projection means comprises a co-operating generally helical rib.

The converter means may comprise a motion converter member disposed in the tubular member and the plunger means may include a plunger tube having a forward portion disposed in the tubular member. ft helical groove may be formed in the motion converter member; and the plunger tube may have an interior peripheral wall and a projection extending therefrom engaging the helical groove, uhereby linear force can be translated to rotary force. 100 - 4 The motion converter member may include a generally cup shaped foruard portion and a tubular shaft extending rearwardly therefrom; the coil carrying member being disposed in said cup-shaped portion.

The cup-shaped portion may include an interior peripheral uall which is non-circular in cross-section; and the cross-sectional shape of said coil-carrying member may be non-circular, whereby rotational movement of the motion converter uill rotate the coil-carrying member and the coil attached thereto.

Preferably the diameter of the coil-carrying member is sufficiently smaller than the diameter of the interior peripheral uall of the cup-shaped portion, uhereby rotational force above a predetermined force applied to said cup-shaped portion uill causB said portion to slip around said coilcarrying member and such force uill not be imparted to said coil-carrying member or said coil.

The apparatus may include means limiting forward movement of the coil-carrying member so as to limit the distance which the coil can move beyond the foruard end of the tubular member.

The foruard end of the tubular member may have a radially inwardly extending flange portion thereon which constitutes abutment means for limiting foruard movement of the coil.

The apparatus may further comprise co-operating abutment means on the rear end of said cup-shaped portion of the motion converter member and on the tubular member for limiting rearward movement of the said motion converter member in the tubular member.

Furthermore the apparatus may further comprise means for normally holding said motion converter member in a predetermined position in said tubular member said means including means adapted to be overridden upon the application of forward force upon said motion converter member above a predetermined force.

The coil which, in use of the apparatus, is attached to the skin of a fetus uill normally be a coil electrode.

IN THE DRAWINGS: Figure 1 is a diagrammatic view illustrating one embodiment of an improved electrode apparatus comprising an electrode structure and applicator constructed in accordance uith the teachings of the present invention, uith the foruard end of the apparatus inserted through the vagina and cervix of a mother in labour, prior to actuation of the plunger assembly and removal of the inssrter tube and plunger assembly.

Figures 2A and 2B, together, constitute a sectional side elevation vieu of the electrode apparatus of the embodiment of the present invention shown in Figure 1 uith the electrode-carrying member and the plunger assembly shown in the positions they occupy prior to the time that the plunger is depressed to project the electrode carrying structure forwardly and consequently cause it to rotate.

• Figure 3 is a transverse section taken along thB plane 3-3 of Figure ZA.

’ Figure 4 is a transverse section taken along the plane 4-4 of Figure 2B.

. Figure 5 is a perspective view showing the forward end of the improved electrode apparatus (shown in Figures 1-4) uith the electrode carrying member projecting forwardly of the foruard end of the inserter tube.

. Figures 6A and 5B, taken together, constitute a sectional elevation vieu similar to 2A and 2B but showing the improved electrode apparatus with the electrode carrying member and plunger in the positions they occupy after ths plunger has been depressed to project the electrode carrying structure forwardly and consequently 3D caused it to rotate.

Figure 7 is a transverse section taken on the plane 7-7 of Figure 6A.

Figures B and 9 are diagrammatic views similar to Figure 1, illustrating the manner in which the electrode apparatus is actuated to attach the spiral electrode - 6 to the fetal epidermis, and the manner in which the inserter tube and plunger assembly may thereafter be removed.

Figure 10 is a sectional side elevation view, similar to Figure 2A, illustrating the forward end of another embodiment of the Blectrode apparatus of the present invention.

• Figure 11 is a diagrammatic view of a preferred embodiment of the electrode apparatus of the present invention.

. Figures 12A and 12B, together constitute a sectional side elevation view of a preferred embodiment of the electrode apparatus of the present invention with the electrode carrying member and the plunger assembly shown in the positions they occupy prior to the time that the plunger is depressed to project the electrode carrying structure forwardly and rotate it.

Figures 13, 14, 15 and 15 are transverse sections taken along the planes 13-13, 14-14, 15-15 and 16-15, respectively, of Figures 12A and 12B.

Figures 17A and 17B, together, constitute a sectional side elevation view similar to Figures 12A and 12B, showing the improved electrode apparatus of the embodiment of the present invention shown in Figures 11-15 with the electrode carrying member and the plunger in the positions they occupy after the applicator has been depressed to project ths electrode carrying member forwardly and to rotate it.

DESCRIPTION OF THE EMBODIMENTS DF FIG. 1-10 Referring to Figure 1, the forward end of electrode apparatus E of the embodiment of the present invention shown in Figures 1-9 is adapted to be inserted through the vagina U and the cervix C of a mother in labour. The electrode apparatus E includes an elongated inserter tube 3 which is generally form-sustaining and whioh is curved to - 7 generally conform to and fit the angular anatomical configuration of a woman's vagina and cervix so as tc be adapted to be comfortably inserted therethrough. The inserter tube 3 is open at its forward and rear ends.

As best shown in Figures 2A and 5 the electrode apparatus E further comprises first and second electrodes 5 and 6 connected, respectively, to the rear and forward ends of a generally cylindrical electrode carrying member 9. The electrodes 5 and 6 are preferably made of stainless steel and have electrical wires 1 and 2 suitably connected (e.g. soldered) thereto. The electrode-carrying member 9 is made of an electrically insulative material, such as a plastics material. The wires 1 and 2 extend through the inserter tube 3 and are adapted to have their outer ends connected to a suitable monitoring apparatus (not shown). Electrode 5 is generally of cylindrical or disc shape and has an opening 7 in its peripheral edge through uhich the wire 1 axtends (see figures 2A and 6A). The wire 1 is insulated throughout most of its length but has a bared forward end 6 connected (e.g. soldered) to the electrode 5. Hire 2, also insulated, extends through the electrodecarrying member 9 and has a bared end 10 soldered to the end 11 of electrode 6. Uire 2 extends from electrode 5 through the electrode-carrying member 9 and thence through an opening in the periphery of electrode 5. The electrode 6 is of generally helical or spiral configuration and has its rear end embedded in the forward end of member 9. The forward end of coiled electrode 6 terminates in a pointed end 12 uhich is adapted to penetrate the epidermis of the fetus F (Figures 1, 8 and 9) in the mother's uterus.

All of the soldered connections are Bpoxy coatBd to insulate them.

A plastics sleeve 13 is mounted on the forward end of the guide tub9 3 by an outer support sleeve or ferrule 13s uhich extends beyond the rear end of the sleeve 13 and extends over the forward end 13b of the tube 3. The - 8 support sleeve 13a is preferably made of stainless steel. Double lead helical grooves 14 are formed in the interior uall of the plastics sleeve 13, and companion double lead helical ribs 15 are provided on the outer surface of the electrode-carrying member 9. Preferably the helix angle of the ribs and grooves is such that forward longitudinal movement of the electrode-carrying member 9 from the fully retracted position (Figure 2fl) uill cause thB electrode-carrying member 9 and spiral electrode 6 to rotate ID through a predetermined arc, e.g. 360 degrees or one revolution. Thus, the pointed, helical electrode 6 can only be inserted into the epidermis of the fetus to a predetermined extent. Such penetration uill be determined by the extent of rotation of the electrode-carrying member 9, as it is projected from the sleeve 13, and the helix angle of the spiral electrode 6.

Uhen the electrode-carrying member 9 is in the fully retracted position shoun in Figure 2A, the pointed tip 12 of the spiral electrode 6 is retracted to a location fully housed uithin the plastics sleeve 13 on the forward end of the inserter tube 3. Thus, the pointed tip 12 can do no damage to the vaginal or cervical tissue of the mother during insertion.

Ths electrode apparatus E is equipped uith a plunger assembly P for projecting the electrode-carrying member 9 foruardly (and consequently causing it to simultaneously rotate). The plunger assembly P includes an elongated, laterally flexible, axially rigid plunger rod 16 uhich extends longitudinally through a substantial portion of the length of the inserter tube 3. The inner or forward end 17 of the plunger rod is preferably rounded and engages a conical seat 18 on the rear surface of the cylindrical electrode 5 (Figures 2A and 6A). This structure permits free rotation of the electrode-carrying member 9 as it is projected foruardly.

The plunger rod 16 extends through a tubular passage 19 provided on the interior uall of the inserter tube 3, - 9 e.g., by a tubular member 19a secured along the interior wall of the inserter tube.

As sean in Figures 2B· and 6B, the rear end of the plunger rod 16 is embedded in a plunger head 21 having an enlarged thumb piece thereon and an elongated plunger shaft 23 uhich extends into the inserter tube 3. The underside of the plunger shaft 23 (as viewed in Figures 2B and 4) has an elongated arcuate groove 24 therein uhich slidably receives the tubular member 19a forming passage 19 as the plunger shaft 23 and rod 16 are moved longitudinally within the inserter tube. This structure prevents relative rotation between the plunger P and the inserter tube 3.

The plunger shaft 23 and the inserter tube 3 are provided with co-opBrative wire holding elements to hold the wires 1 and 2 in a fixed position prior to the time it is desired to project the spiral electrode 6 into the fetus.

As shown in Figures 2B, 4 and 6B, these holding elements comprise a radially outwardly projecting lug 25 on the plunger shaft 23 and a radially inwardly projecting lug 26 on the interior uall of the inserter tube 3 near the rear end thereof. Uhen the lugs 25 and 26 are in the confronting relationship illustrated in Figures 2B and 4, the electrode wires 1 and 2 are friotionally clamped therebetween, Uhen the plunger structure P is pressed inwardly into the inserter tube 3, as shown in Figure 6B, the clamping action is relieved since lugs 25 and 26 are no longer in a confronting relationship, and the wires 1 and 2 may move forwardly with ths electrode-carrying member 9.

Depression of the plunger structure P is facilitated by provision of a finger engaging flange 27 (see Figures 2B, B and 9) on the rear end of the inserter tube 3.

In use, inserter tubs 3 is inserted through the vagina V and cervix C of the patient and into contact with the fetus F, as shown in Figure 1. Thereafter, the plunger P is depressed (Figure B), releasing the frictional clamp on the wires 1 and 2 and progressively causing forward movement of thB electrode-carrying member body 9, As the - 10 electrode-carrying member 9 moves forwardly, the co-operating helical grooves 14 and 15 cause rotation of the helical electrode 6 through a predetermined arc to penetrate and engage the fetal epidermis. Thereafter, the inserter tube 3 is removed from the mother, leaving the electrode structure in place, as illustrated in Figure 9.

The primary difference between the embodiment shown in Figure 10, compared to thB embodiment of Figures 1-9, is that in the Figure 10 embodiment the helical grooves 114 ere formed in the outer peripheral surface of the electrode carrying member 109 and thB companion ribs 15 are provided cn the interior wall of the sleeve 113 on the foruard end of the inserter tube 103. The foruard end of the plunger rod 15 engages the conical seat IS of the electrode member 105. The wire 101 has its bared end 108 electrically connected, as by soldering, to the electrode 105. The wire 102 extends longitudinally through the electrode-carrying member 109 and has its bared end 110 connected, as by soldering, to the coiled electrode 106, The Figure 10 embodiment also includes a stop ring or flange 130 which projects radially inwardly to limit rearward (or inward) movement of the electrode-carrying member 109. Thus, when the electrode-carrying member 109 is retracted and the electrode wires 101 and 102 are clamped, both inward and outward movement of the electrode-carrying member are prevented.

DESCRIPTION OF THE EMBODIMENT OF FIGS. 11-17B Referring to Figure 11, the forward end of the electrode apparatus EE of the embodiment of the present invention shown in Figures 11-17B is adapted to be inserted through the vagina and cervix of a mother in labour. The electrode apparatus EE includes an elongated inserter tube 103 which is generally form-sustaining and which is curved to generally conform to and fit the angular anatomical configuration of a woman's vagina and cervix so as to be adapted to be comfortably inserted therethough. The - 11 inserter tube 103 is open at its foruard and rear ends.

Referring to Figures 12A and 17Λ, the electrode apparatus EE further comprises a generally helical or coil electrode 106 having its rear end portion embedded in an electrode-carrying member 109 and projecting forwardly (i.e. to the left, as viewed in Figures 12ft and 17A) therefrom. The forwardly-projecting end 112 of electrode 106 is pointed tc facilitate penetration of the skin of a fetus uhen the foruard end of the electrode apparatus EE is inserted through the mother's vagina and actuated as described hereinafter.

The electrode-carrying member 109 also carries a second electrode 105, preferably of an annular configuration, attached to its rear end.

The electrodes 105 and 106 are preferably made of stainless steel and have electrical wires 101 and 102 suitably connected (e.g. soldered) thereto.

The electrode-carrying member 109 is preferably made of an electrically insulative material such as a plastics material. The electrode carrying member 109 is disposed in a cup-shaped portion 152 of a motion convertertransmitter 150. The cross-sectional shapes of the electrode-carrying member 109 and the interior uall of the cup-shaped portion 152 may be non-circular (e.g. octagonal, as shoun in Figure 13, so that rotational force and motion of the motion converter 150 uill be transmitted to the electrode-carrying member 109 and the coil electrode 105.

The outer diameter of the electrode-carrying member 109 is preferably somewhat smaller than the inside diameter of the cup-shaped portion 152 so that the electrodecarrying member 109 sits somewhat loosely in the cup-ohaped member. By virtue of this structure, while rotational motion of the cup-shaped member 152 transmits rotational movement tc the electrode-carrying member 105 and the coil electrode 106, excessive torque applied to the cup-shaped member 152 uill cause it to slip around the electrode48100 - 12 carrying memeber, thereby preventing potential harm to the fetus.

The uires 101 and 102 extend through the inserter tube 103 and are adapted to have their outer ends 105’, 105' connected to a suitable monitoring apparatus (not shown).

Electrode 105 is generally of cylindrical or disc shape and has a central opening 107 through uhich the uires 101 and 102 extend (sbb Figure 12A).

The wire 101 is insulated throughout most of its length but has bared forward end 108 connected (s.g· soldered) to the electrode 105. Uire 102 is also insulated throughout most of its length, extends through the rear portion of the electrode-carrying member 109 and has a bared end 110 soldered to the rear end 111 of coil electrode 106.

J All of the soldered connections are preferably epoxy coated to insulate them.

A plastics sleeve 113 is mounted on the forward end of the inserter tube 103, as by a peripheral crimp 115’ (Figures 12A and 17A), for example. The forward end of the sleeve 113 has a radially inwardly extending, peripheral flange 117 integrally connected thereto for limiting forward movement of the cup-shaped member 152 in a manner described hereinafter.

The electrode apparatus EE is equipped with a plunger assembly PP (Figures 128 and 17B) for projecting the 8lectrode-carrying member 109 and coil electrode 106 forwardly and rotating them. The plunger assembly PP includes an elongated, laterally flexible, axially rigid plunger tube 116 uhich extends longitudinally through a substantial portion of the inserter tube 103.

The forward end of the plunger tubB 116 has a pair of radially inwardly extending projections 118, 118 integrally formed on its interior peripheral wall for engaging helical grooves 158, 158 on a linear-to-rotary converter member 150, as described more fully hereinafter. - 13 Since the inserter tube 103 and the plunger tube 116 are curved, with substantially the same degree of curvature, relative rotational movement therebetween is inhibited.

The rear end of the plunger tube 116 includes a longitudinally extending guide slot 120 uhich co-operates with a radially inwardly projecting ridge 122 on the rear end of the inserter tube 103 tD limit rearward movement of the plunger tube in the inserter tube and to further inhibit relative rotational movement between the inserter tube and the plunger tube. See Figures 12B and 15.

As best shown in Figures 12B and 17B the rear end of the plunger tube 116 is embedded in a plunger head 121.

Depression of the plunger tube 116 is facilitated by provision of a finger engaging flange 127 on a bushing 12B attached to the rear end of the inserter tube 103, as best shown in figures 12B and 17B.

The electrode apparatus EE of the present invention includes a linBar-to-rotary motion converter 150 disposed between the plunger tube 116 and the electrode carrying member 109 for translating linear force applied to the plunger head 121 to first linear and then rotary motion of the electrode carrying memeber 109 and the coil electrode 106.

The motion converter 150 includes a generally cupshaped portion 152 on its forward end and a rearwardly extending tubular shaft 154.

The cup-shaped portion 152 carries the electrodecarrying member 109, and its interior peripheral uall 156 is octagonally shaped (see Figure 13) to conform to the octagonal cross-sectional shape of the electrode-carrying member 109, whereby rotary motion of the converter 150 and cup-shaped portion 152 will result in rotary motion of the electrode carrying member 109 and the coil electrode 106, The conversion of linear to rotary motion is accomplished by means of double lead helical grooves 158 in the exterior wall of thB rearwardly extending shaft 154 and the radially inwardly extending pins 118, 118 in the forward - 14 end of thB plunger tube 115. Linear movement of the □lunger tube 116 in a forward direction (i.e. to the left as viewed in the drawings) from the position of Figure 12A to the position of Figure 17A will, by virtue of the pins 118 engaging the hBlical grooves 158, cause the motion converter 150, the electrode carrying member 109 and the coil electrode 106 to rotate, sincB the plunger tube 116 is constrained against rotary movement relative to the inserter tuba 103.

The electrode apparatus EE includes structure for limiting forward movement of the coil electrode 106 in order to provide a uniformly stable structure during rotation which also insures against unnecessary harm to the fetus since foruard movement of the coil electrode is completely controlled.

As best shown in Figures 12A and 17A, a radially inwardly extending peripheral flange 117 is provided on the forward end of tha plastics sleeve 113' on the forward end of the inserter tube 103. The interior peripheral edge 162 of the flange 117 is large enough to permit movement of the forward end of the electrode carrying member 109 there through, but small enough to engage and stop the foruard end of the cup-shaped portion 152 of the motion convertor 150 (see Figure 17A). Thus, once the motion converter has been projected forwardly to the point shown in Figure 17A, the coil electrode 106 cannot advance further foruardly, and continued depression on the plunger tube 116 will result only in rotary motion of the motion converter 150 and tha electrode-carrying member 109 and coil electrode 106 carried thereby.

As shown in Figures 12A and 17A, the rear portion of the cup-shaped portion 152 of the motion converter 150 is flared radially outwardly at its rear end to provide a peripheral edge 164 which engages the forward end 166 of the inserter tube 103 to limit rearward movement of the motion converter 150. - 15 A peripheral crimp. 168 is provided around the sleeve 113, foruardly of the crimp 115' and the forward end 166 of the inserter tube 103, to positively hold the motion converter 150 in the position shoun in Figure 12A prior to use of the apparatus. Uhen the attending physician introduces the inserter tube 103 into the mother's vagina and positions the apparatus preparatory to applying the coil electrode 106 to the fetal epidermis, depression of the plunger tube 116 uill cause the flared rear peripheral edge 164 of the cup-shaped portion 152 of the motion converter 150 to override the peripheral crimp 168 and permit the coil electrode to be moved foruardly to the position shoun in Figure 17A.

The distance between the forward end 166 of the inserter tube 103 and the peripheral stop flange 117 on the sleeve 113' may De selected to ensure that the electrodecarrying member 109 and the coil electrode 106 uill move foruardly only a predetermined distance necessary to penetrate the fetal epidermis.

As shoun in phantom lines in Figures 128 and 16, the apparatus EE of the Figures 11-17 embodiment may be equipped uith a locking mechanism to hold the plunger tube 116 rod in the retracted position shown in Figures 11, 12A and 12B during shipping and storage, prior to use. The locking mechanism includes a generally flexible tubular piece 180 formed uith an opening 182 into uhich the outer ends 105' and 106' of wires 105 and 106 may be inserted and retained.

UhBn it is desired to use the apparatus EE, the outer ends of wires 105 and 106 are removed from the opening 182 and the tubular piece 180 is slipped off of the outer end of the plunger tube 116.

The forward end of the inserter tube 103 may then be inserted through the vagina and cervix of the mother and into contact uith the fetus. Thereafter, the plunger head 121 is depressed to drive the plunger tube 116, motion converter 150, electrode carrying member 109 and coil electrode 106 foruardly, to the position shoun in Figure 17A, - 16 wherein the pointed forward end 112 of the coil electrode 106 engages and penetrates the skin of the fetus. UhBn the motion converter 150 is pressed forwardly, the flared rear peripheral edge 164 of the cup-shaped portion 152 over5 rides the inwardly-projecting radial crimp 168 in the sleeve 113. Forward movement of the coil electrode 106 is limited by the forward end 151 of the cup-shaped portion 152 engaging the peripheral flange 117 of the sleeve 113’, as shown in Figure 17A.

As the plunger head 121 is further depressed, the resulting linear forcB 121 will, by virtue of the pins 118 engaging the double helical grooves 158 in the outer surface of the shaft portion 154 of motion converter 150, cause thB motion converter 150 and the electrode carrying member 109 carried thereby to rotate, thereby rotating the coil electrode 106 into the fetal epidermis FF (Figure 17A).

While the particular embodiment of the electrode apparatus EE depicted in Figures 11-17 utilizes non-circular (e.g. octagonal) cross-sectional shapes of the electrode carrying member 109 and the interior peripheral wall of the cup-shaped member 152 of the motion converter 150 to the electrode carrying member 109 and the coil electrode 106, it is contemplated that any other suitable structure may be employed for this purpose. For example, it is contemplated that the slot structure of the invention of U.S.-E28,990 may be employed. See, e.g. Figure 8 of the US-E- 28,990 Patent wherein the second electrode 222 is engaged by slots 252, 252 on the forward end of a tubular drive member 254, whereby rotational movement and force of the drive tube 254 is transmitted to the electrode carrying member 214 via the flat electrode 222. This drive structure may be incorporated in the embodiment EE of Figures 11-17B by making the electrode 105 flat (similar to the electrode 222 of Figure 8 of OS-E- 28,990) and forming slots in the motion converter 150.

From the foregoing it is believed that thB advantages of the present invention over US-E.- 28,990 - 17 may be appreciated. The electrode apparatus of the present invention is safer in that the degree of rotation of the spiral electrode is completely controlled, i.e. the physician cannot turn the electrode-carrying member and the spiral electrode through more than a predetermined arc (e.g. one revolution), thus greatly reducing the possibility of fetal damage from excessive electrode rotation.

Another advantage of the apparatus of the present invention is that the electrode-carrying member and the electrode mounted therein are positively held in position within one forward end of the inserter tube by virtue of the co-operating ribs and grooves. Consequently, the possibility of electrode rotation failure (due to inadvertent disassembly of the electrode rotating mechanism during insertion through the vagina and cervical canal) is greatly reduced.

Further, the spiral electrode is held in a completely retracted position within the inserter tube, thereby avoiding damage to the tissue of the mother during insertion of the structure.

Still further, actuation of the device to engage the spiral electrode in the fetal epidermis is effected automatically by simply depressing the plunger structure.

It is unnecessary to disengage any wedge or look mechanism by a separate motion.

The embodiment shown in Figures 11-17B offers additional advantages not realized by the embodiments of Figures 1-10, for example: (1) In the apparatus of Figures 11-17B the distance of projection of the coil electrode 105 beyond the end of the inserter tube 103 can be controlled. In the embodiments of Figures 1-10, the extent of projection is related to the position of the helixes, and rotational stability of the coil electrode decreases as the electrode rotates.

With the improved apparatus of the embodiment of Figures 1117B, the extent of linear movement of the electrode is - 18 limited and adjustable to provide uniform stability during rotation. (2) The amount of rotation (i.e. the number of turns) of the coil electrode may be readily controlled by selecting predetermined lengths of the helical tracks in the electrode carrying member 109. In the embodiment of Figures 1-10, rotational control requires changing the length and/or diameter of the electrode carrying member 9. (3) The apparatus of the Figures 11-17B is simpler and somewhat more desirable in that the need for having the plunger rod (of the Figures 1-10 embodiments) seat in the conical depression in the rear end of the second electrode 5 has been eliminated and the functions of the plunger and part of the rotating mechanism have been combined into a single unit. (4) The annular shape of the electrode 105 permits the electrode wires to pass conveniently through its centre, thereby providing for excellent electrical and mechanical stability. (5) The design of the apparatus EE provides a simple and convenient method fcr attaching various types of sensors to the fetus, uith or without the use of resins, adhesives □r glues. (5) ThB locking mechanism limits the range of movement of the plunger.

It is contemplated that various modifications, additions and deletions of structure may be made to the particular illustrative embodiments described above shoun in the drawings uithout departing from the spirit and scope of this invention. (By uay of example only, it is contemplated that hydraulic or pneumatic means or a spring mechanism may be employed to effect application of the electrode structure). Accordingly, it is intended that the present invention be limited only by the scope of the appended claims.

Claims (18)

1. A Fetal monitoring apparatus comprising a tubular member having a foruard end adapted to be inserted through the vagina and cervix of a uoman in labour, a coil movably mounted in the tubular member, the coil being adapted to be 5 attached to the skin of a fetus, characterised in that the apparatus includes converter means uhereby an applied linear force can be converted to rotary force to turn said coil.

2. A fetal monitoring apparatus according to Claim 1, 10 characterised in that the coil is mounted on a coilcarrying member and extends foruardly therefrom and the apparatus includes plunger means, the said converter means being adapted to translate linear force applied to the plunger means to rotary for.ce applied to the coil carrying 15 member.

3. An apparatus according to Claim 2, characterised in that the converter means comprises a generally helical groove and projection means engaging uith said groove.

4. An apparatus according to Claim 3, characterised in 20 that the groove is disposed on one of the coil-carrying members or the tubular member and the projection means disposed on the other of the coil carrying member or the tubular member.

5. An apparatus, according to Claim 3 or Claim 4, 25 characterised in that the projection means comprises a co-operating generally helical rib.

6. An apparatus according to Claim 3, characterised in that the converter means comprises a motion converter member disposed in the tubular member and the plunger means 30 includes a plunger tube having a foruard portion disposed in tha tubular member.

7. An apparatus according to Claim 6, characterised in that a helical groove is formed in the motion converter member; and uherein the plunger tube has an interior 35 peripheral uall and a projection extending therefrom engaging tha hBlical groove, uhereby linear force can be - 20 translated to rotary force. 6. An apparatus according to Claim 7, characterised in that the motion converter member includes a generally cupshaped forward portion and a tubular shaft extending 0 rearwardly therefrom; the coil carrying member being disposed in said cup-shaped portion.

8. 9. An apparatus according to Claim 8, characterised in that the cup-shaped portion includes an interior peripheral uall which is non-circular in cross-section; and the cross10 sectional shape of said coil-carrying member is noncircular, whereby rotational movement of the motion converter will rotate the coil-carrying member and the coil attached thereto.

9. 10. An apparatus according to Claim 9, characterised in that J· 5 the diameter of the coil-carrying member is sufficiently smaller than the diameter of the interior peripheral uall of the cup-shaped portion, whereby rotational force above a predetermined force applied to said cup-shaped portion will cause said portion to slip around said coil-carrying member 20 and such force will not be imparted to said coil-carrying member or said coil.

10. 11. An apparatus according to any one of Claims 2 to 10, characterised in that, the apparatus includes means limiting forward movement of the coil-carrying member so as to limit 25 the distance uhich the coil can move beyond the forward end of the tubular member.

11. 12. An apparatus according to Claim 11, characterised in that the forward end of the tubular member has a radially inwardly extending flange portion thereon uhich constitutes 30 abutment means for limiting forward movement of the coil.

12. 13. An apparatus according to any one of Claims 8 to 10, characterised in that it further comprises co-operating abutment means on the rear end of said cup-shaped portion of the motion converter member and on tha tubular member for 35 limiting rearward movement of said motion converter member in the tubular member. 48 100 -2114. An apparatus according to any one of Claims 6 to 10, characterised in that it further comprises means for normally holding said motion converter member in a predetermined position in said tubular member said means including means 5 adapted to be overridden upon the application of forward force upon said motion converter member above a predetermined force.

13. 15. Apparatus according to Claim 7 characterised in that the motion converter member includes a generally cup-shaped 10 portion, the coil carrying member being disposed in the cupshaped portion, and the cup-shaped portion has slots, or other recesses, and the coil carrying member has projection means which can engage with said slots or recesses, whereby rotational movement of the motion converter will rotate the 15 coil carrying member and the coil attached thereto.

14. 16. Apparatus according to Claim 15 characterised in that the coil is an electrode coil and the projection means of said coil carrying member form part of a second electrode.

15. 17. A fetal monitoring apparatus comprising a tubular 20 member having a forward end adapted to be inserted through the vagina and cervix of a woman in labour, a coil electrode movably mounted in the tubular member, the coil being adpated to be attached to the skin of a fetus, characterised in that the coil electrode is carried by an electrode 25 carrying member, which carries a second electrode, and that the apparatus also has plunger means, a motion converter member which has a cup-shaped portion in which the electrode carrying member is disposed, converter means whereby a linear force applied to said plunger means, can be converted to -22rotary force to turn said electrode carrying member, the converter means comprising a generally helical groove and projection means engaging said groove, the groove being carried by one of the tubular member or means associated 5 with the motion converter member and the projection means being carried by the other of the tubular member and said associated means, the apparatus further including means for connecting the electrode carrying member and said cup-shaped portion whereby rotational movement of the motion converter 10 member is transmitted to the electrode carrying member.

16. 18. Fetal monitoring apparatus substantially as hereinbefore described with reference to Figures 1-9 of the accompanying drawings.

17. 19. Fetal monitoring apparatus substantially as herein15 before described with reference to Figure 10 of the accompanying drawings.

18. 20. Fetal monitoring apparatus substantially as hereinbefore described with reference to Figures 11 to 17 of the accompanying drawings. 20 21. Fetal monitoring apparatus according to Claim 1 substantially as hereinbefore described.