JP3974187B2 - Obstetric medical instrument apparatus and method - Google Patents

Description

TECHNICAL FIELD OF THE INVENTION
The present invention relates to an apparatus and method for monitoring the birth of a mammal.
Background art
During childbirth, medical personnel typically monitor the degree of maternal cervical dilatation, the location of the fetus in the cervix and uterus, and the strength and frequency of maternal muscle contraction. Most of this monitoring process is performed by direct visual observation and manual palpation. Various instruments have been proposed to assist this monitoring process. As disclosed in U.S. Pat. No. 5,438,996, a cervical instrument for monitoring cervical dilatation is constructed based on a direct mechanical or ultrasonic instrument. . In the case of an ultrasonic cervical instrument, a small ultrasonic transmitter is attached near the opening of the mother's cervix, and a small receiving device is attached on the opposite side of the opening of the cervix. Thus, the signal transmission time between these transmitters and receivers indicates the distance between them, ie the extent of cervical dilation. As disclosed in U.S. Pat. No. 5,438,996 and described in more detail in U.S. Pat. No. 3,768,459, an electromagnetic cervical measuring device is an electromagnetic device attached to one end of the cervix. A transmission coil and an electromagnetic reception coil attached to the other end are used. Therefore, the electromagnetic coupling strength between these coils indicates the distance between the transmitter and receiver, ie the degree of cervical dilatation.
As described in US Pat. No. 3,913,563, the strength of uterine contractions can be monitored using a strain gauge. A flexible lead is mounted on the frame held by the belt. The belt holds the frame against the abdominal wall. The lead extends into the frame and contracts the abdominal wall. Thus, shrinkage is caused by lead movement. That is, the strength of muscle contraction can be known from the degree of movement. As described in US Pat. Nos. 5,634,476 and 5,218,972, pressure changes caused by contraction can be measured by a pressure measuring device held in the abdomen.
Other monitoring devices used during childbirth are used to monitor fetal conditions during the above treatment. For example, the pulse monitor device can be physically attached to the fetus, for example, by attaching the pulse monitor device to the fetal scalp through an opening in the cervix.
However, in addition to the improvements described above, further improvements are desired for the monitoring of childbirth and monitoring of similar treatments in non-human mammals.
Disclosure of the invention
One aspect of the present invention provides an apparatus for monitoring the delivery of a fetus from a human or non-human mammalian maternal body. The device according to this aspect of the invention comprises one or more maternal probes and means for fixing the maternal probe to a mother near the uterus. For example, the matrix probe includes an external matrix probe disposed outside the matrix. In addition, the maternal probe includes a cervical probe attached to the cervix.
The apparatus also includes one or more reference elements and means for holding the elements in the vicinity of the matrix. Preferably, the reference element is located at a location that is substantially isolated from movement caused by uterine contractions. For example, one or more external maternal probes are attached to the exterior of the mother's abdomen, but the one or more reference elements are relatively isolated from the effects of uterine contractions such as, for example, behind the vertebrae or limbs Fixed to the mother body. The one or more reference elements can also be mounted on a bed that supports the mother or a frame that can be moved to a location close to the bed.
The apparatus further comprises transmitting means for driving the probe and reference element to transmit one or more non-ionic fields such as electromagnetic fields or ultrasound waves and detect the transmitted fields. . Thus, each field transmitted by one element of the transceiver pair including the reference element and the mother probe is detected by the other element of the pair. Most preferably, the apparatus further comprises computing means for determining the placement of each maternal probe relative to one or more reference elements from the detected field characteristics. As used in this disclosure, the term “desposition” means position or direction or both. Most preferably, it is configured to determine at least the position of each maternal probe in a reference coordinate space defined by one or more reference elements.
Preferably, the calculation means includes means for determining a magnitude of movement of the maternal probe caused by uterine contraction and supplying a contraction signal corresponding to each maternal probe indicating the magnitude of movement of the maternal probe. . Most preferably, the calculation means comprises means for determining the direction of movement of each mother probe caused by contraction, and the contraction signal indicates the direction of movement of the probe together with the magnitude of movement of the mother probe. Thus, in the most preferred embodiment, the contraction signal indicates a vector of movement of the maternal probe. Therefore, definitive information is obtained by a single contraction signal from a single maternal probe, but more detailed information can be obtained by using multiple maternal probes. In this case, it is preferable that the means for attaching the external mother probe is configured to attach the probe to a place where the mother body is separated. For example, when the attachment means includes an attachment element such as an adhesive for fixing the external mother probe to the skin, the external mother probe can be manually supplied to the space.
The calculation means is configured to generate a separate contraction signal indicative of its movement for each probe and combines the contraction signals from multiple probes to provide a composite signal indicative of one or more parameters of uterine contraction. It is preferable that it is comprised. For example, a composite signal representing the magnitude of contraction is obtained by combining the magnitudes of movement of the probes, such as by summing scalar representations of magnitudes of movement of several maternal probes. In addition, several contractions from several maternal probes, for example by using a vector sum of the movement vectors of the individual maternal probes providing a composite contraction vector representing the magnitude and direction of the movement caused by the contraction as a whole. By combining the magnitude and direction included in the signal, it becomes possible to obtain a composite signal with a larger amount of information.
By using individual contraction signals or composite signals from individual probes, the ability to detect both the magnitude and direction of contraction is significantly enhanced. In addition, this allows the physician to detect abnormal contractions such as reverse contractions that move the fetus to the diaphragm side opposite the cervix. If such an abnormal contraction or other abnormal condition is detected, the doctor can intervene in the delivery, for example by initiating a caesarean section. Conversely, early detection of abnormal conditions allows the physician to initially intervene in abnormal muscle movement. As a result, the mother's unnecessary pain can be minimized, and the fetus can be saved from damage that can occur due to redundant abnormal muscle movements. In addition, this saves money from long and useless stays in the delivery room. As will be described in detail later, the mother probe can be made as small as it does not get in the way. Each such maternal probe includes a small transducer configured to detect or transmit a non-ionic field such as a magnetic field, an electromagnetic field, or the like. The aspect of the above calculation means for converting the structure of these transducers and the detected field characteristics into the placement of each probe is a function of the position and orientation of the in-vivo probe in the case of image guided surgical methods, in-body mapping and other techniques. The same as previously used for tracking. Transducers and field measuring devices developed for these applications can be very small, with diameters of a few millimeters or less, and can monitor position and direction continuously with an accuracy of a few millimeters or less. Such capabilities can adequately meet what is needed in the preferred embodiment of the present invention.
Computable composite signals include the magnitude and / or direction of movement of one or more maternal probes relative to one or more other probes. For example, when a plurality of external maternal probes are provided at positions separated from the outer periphery of the abdomen, the magnitude of contraction movement is indicated by the magnitude of movement of the maternal probes facing each other, for example, toward the center of the abdomen. A composite signal can be provided. Further, when a plurality of maternal probes are arranged at a plurality of axially spaced positions, i.e., positions spaced apart from each other in the axial direction from the head of the mother body to the toe, the phase difference or time delay between the contraction signals Information about the propagation mode along the contraction matrix can be obtained. Furthermore, combinations of the above techniques can also be used.
The cervical maternal probe alone or in cooperation with an external maternal probe provides a contraction signal as described above. Furthermore, when a plurality of cervical maternal probes are provided, the distance between the cervical maternal probes can be obtained by comparing the positions of these cervical maternal probes, and the degree of cervical dilatation can be measured. .
The apparatus further comprises a fetal probe and means for fixing the fetal probe to the fetus. The transmitting means drives the fetal probe and one or more reference elements, and includes at least one additional element between at least one additional transmitter / receiver pair including the fetal probe and the reference element. Provides a means to transmit additional fields. Furthermore, the calculation means comprises means for determining the placement of the fetal probe relative to the reference element. Thus, fetal movement can be tracked relative to the reference element. In this case, the movement of the fetal probe relative to the reference element is used as information directly indicating the movement of the fetus in the cervix. Also, information representing the movement of the fetus relative to the mother is provided by offsetting the movement of the mother relative to the reference element by subtracting the movement of one or more mother probes relative to the reference element from the movement of one or more fetal probes relative to the reference element. Is done. Thus, in one variation of the device, a fetal probe is used without a maternal probe.
Accordingly, another aspect of the invention provides a fetal probe for monitoring the position of a fetus during childbirth, the fetal probe being configured to detect or emit one or more non-ionic fields. A field transducer and means for securing the field transducer to the fetus are provided. Preferably, the field transducer is a magnetic field transducer configured to detect magnetic field components in at least two different local directions relative to the probe and provide separate data for each component. For example, the fetal field transducer includes two or more coils or solid state sensors having non-parallel coil axes or sensing axes. The fetal probe further includes a fetal heart rate monitor transducer. The means for fixing the field transducer to the fetus is preferably configured to fix the fetal heart rate monitor field transducer to the fetus. Therefore, a composite transducer having a heart rate monitor and a position monitor function can be integrated without being substantially larger than the heart rate transducer alone.
Yet another aspect of the present invention includes a method of monitoring fetal birth from a non-human mammalian maternal body. The method according to this aspect of the invention includes the step of securing one or more probes near the uterus in the mother and holding the one or more reference elements in the vicinity of the mother. Further, the method according to this aspect of the invention includes driving the probe to transmit one or more non-ionic fields and to detect the transmitted fields. Again, each field is transmitted by one element of a pair of transceivers including a reference element and a parent probe and detected by the other element of the pair. The method according to this aspect of the present invention preferably includes determining the placement of each maternal probe relative to one or more reference elements from the detected field characteristics. The preferred method further comprises calculating the magnitude or direction of movement of each maternal probe due to contraction, most preferably both, and providing a contraction signal indicative of the direction or magnitude or both. Including. The contraction signals from the individual probes can be combined to provide a composite signal by a method based on the apparatus described above. In yet another embodiment of the present invention, the maternal probe includes two or more maternal probes attached to opposing surfaces of the cervical opening or hole. That is, by monitoring each position of these mother probes relative to one or more reference elements, the position between the mother probes can be determined. This indicates the degree of cervical dilation. The above matrix probe can also be used in contraction monitoring processes other than those described above.
In a variation of the above method and apparatus, the matrix probe and the reference element are fixed to the matrix in the area affected by the movement due to contraction. In this case, by monitoring the position of the mother probe relative to the reference element, the relative movement of these probes due to contraction can be monitored. For example, movement information between the probes is obtained as instruction information on the magnitude of contraction.
The above and other objects, features and advantages of the present invention will become more apparent from the following detailed description of preferred embodiments based on the accompanying drawings.
[Brief description of the drawings]
FIG. 1 includes a partial cross-sectional view and a partial block diagram of an apparatus according to an embodiment of the present invention.
FIG. 2 is a schematic cross-sectional view taken along line 2-2 in FIG.
FIG. 3 is a schematic perspective view of the components used in the apparatus of FIGS.
FIG. 4 is an enlarged perspective view of a part of the components shown in FIG.
FIG. 5 is a view similar to FIG. 4 showing components according to another embodiment of the present invention.
FIG. 6 is a schematic partial sectional view showing a portion of the apparatus shown in FIGS. 1 and 2.
FIGS. 7 and 8 are diagrams illustrating some vectors determined during operation of the apparatus of FIGS.
FIG. 9 is a schematic view of a screen in an example of an operation mode of the apparatus shown in FIGS.
FIG. 10 is a schematic diagram of an apparatus according to yet another embodiment of the present invention.
Best Mode for Carrying Out the Invention
The apparatus according to one embodiment of the present invention comprises a first set of reference elements 10 attached to the underside of a patient support 12. Each reference element 10 includes a conductor coil 11 that defines a coil axis 14 concentric with the coil. These elements may be arranged, for example, in arrays as disclosed in International Patent Publication Nos. WO 97/32179 and 97/29709, which are incorporated herein by reference. For example, the reference element 10 can be placed at each vertex of a triangle such that when the mother is sleeping on the table 12, the center is placed below the mother's abdomen.
This device comprises a frame 16 attached to a table 12 by a deformable support 18. The support 18 may be a deformable wrinkled tube of the type commonly used for the support of so-called “goose neck” lamps. The support portion 18 can be disposed so as to be close to the mother M sleeping on the table 12 as desired, and is held at a substantially constant position until the frame 16 is gripped and moved or unless it is moved. It is configured as follows. Another suitable support for the frame 16 is connected to the table 12 by a movable joint, and is held by an appropriate detent or brake so that the support table 16 can be held unless it is intentionally moved. A plurality of arms connected to each other are included. The frame 16 can be held by a support portion fixed to the table 12 or a support portion fixed to the table by a clamp. Preferably, such a locking mechanism comprises a removal mechanism that can be removed from the platform so that it can be opened to allow better treatment of the mother in an emergency. In addition, another set of reference elements 20 is attached to the frame 16. Similar to the reference element 10, the reference element 20 includes a conductor coil that defines the coil axis 22. Since the reference elements 20 are arranged in an array, the coil shaft 22 is not on the same line. Such a frame 16 and a reference element 20 are described, for example, in International Patent Publication No. WO 97/29683, the disclosure of which is incorporated herein by reference.
The apparatus of the present invention further includes a set of external matrix probes 24. As best shown in FIG. 3, each external matrix probe 24 includes a pad 26 made of a flexible, conformable material such as a polymer material such as soft vinyl commonly used as a self-adhesive bandage or cloth. A multi-axis transducer 30 is attached to the upper surface 28 of the pad. Furthermore, the transducer 30 comprises a support 32 (FIG. 4), which supports a plurality of non-coplanar surfaces, preferably mutually orthogonal surfaces 34, and a plurality of separate sensing elements attached to the support. 36. These sensing elements are configured to detect magnetic field components in a specific direction, such as Hall effect sensors, magnetoresistive sensors, magneto-optical sensors, and magnetic flux gate magnetometers, and generate component signals representing the strength of the magnetic field components. Sensor. Accordingly, sensing element 36a is configured to produce a component signal representative of the field component intensity in direction 38a, and sensing elements 36b and 36c are configured to produce a component signal representative of the field component intensity in directions 38b and 38c, respectively. Has been. These directions 38a, 38b, and 38c are in the reference coordinate space of the support portion 32, and are in a local direction with respect to the reference coordinate space of the probe. Preferably, the sensing element is configured to detect magnetic field components along mutually intersecting axes or axes close to each other, the detected component representing a magnetic field component at or near a single point. . In the specific configuration illustrated in FIG. 4, the local direction or the sensing direction is orthogonal to each surface of the support portion, but this is merely an example. That is, depending on the type of sensor, the sensing direction may be parallel to the surface of the support. However, it is desirable that these sensing directions are orthogonal to each other. The sensor 30 can be formed, for example, as described in International Patent Publication No. WO 95/09562, which is incorporated herein by reference. That is, according to International Patent Publication No. WO 95/09562, the sensing element can be mounted on a flexible sheet material such as a polyimide dielectric that can be deformed to fit the surface of the support. Also, as disclosed in International Patent Publication No. WO 95/09562, the sensor includes one or more amplifiers for amplifying the sensor signal. Lead wires 40 extend along an elongated cable 42 that is integrally formed with the pad 26. The external maternal probe 24 is configured to give the patient as much calm as possible and to withstand conditions that occur during use in the delivery room. For example, the maternal probe 24 includes a cover or capsule (not shown) that covers the sensor 30 for protection and cushioning. As described in the above-mentioned International Patent Publication No. WO 95/09562, this type of sensor can be incorporated into a small intracorporeal probe such as a small catheter because it is several millimeters or less than one millimeter in size. While such small dimensions are desirable, they are not necessary when using the sensor in an external matrix probe. Accordingly, the sensor may have a size of several millimeters to one centimeter or more. This allows the use of sensing elements that are larger, more economical and more powerful than sensors used in the body.
In a variation, transducer 30 '(FIG. 5) includes a set of coils 36a', 36b 'and 36c' wound around non-parallel axes 38a ', 38b' and 38c '. Most preferably, the axes 38a ', 38b' and 38c 'are orthogonal to each other and intersect each other. Each coil is configured to detect a magnetic field component along the respective coil axis. These coils can also be used as field transmitters. In addition, each coil generates a field along the associated coil axis.
The apparatus further includes a pair of cervical maternal probes 44. In addition, each cervical maternal probe includes a transducer 46, which can be identical to the transducer described with reference to FIGS. 4 and 5 mounted in a small housing 48. Each housing 48 is provided with a tissue anchor 50 that is in the form of a device configured to secure a jaw-like, hook, grasper or screw-like housing 48 and includes an attached transducer 46. It can be fixed to maternal uterine tissue near the cervix C. In addition, any other suitable form of anchoring device that can secure the maternal cervical probe can be used. For example, other elastic members or clips can be applied to hold the maternal cervical probe to the tissue. Further, the housing may be provided with a suture hole so that the tissue can be sutured. In addition, the maternal cervix is provided with a cable 52. Most preferably, the maternal cervical probe and cable are as small as possible.
The apparatus further includes a fetal probe 54. The fetal probe includes a securing device 56, such as a clip, that is configured to secure one or more transducers 58 that can monitor the condition of the fetus to the scalp of fetus F during childbirth. The fetal status monitor transducer includes conventional elements for monitoring the fetal heart rate, such as electrodes used for pulse oximetry or luminescence and light detection devices. The structure of this fetal monitor device is known in the art, and any suitable combination of a transducer and a fixing device useful for fetal monitoring using a probe fixed to the fetus during childbirth can be used as a part of the fetal probe 54. The fetal probe further comprises a magnetic field transducer 60 similar to the field transducer described above. The magnetic field transducer 60 is connected to a fixation device 56 so that when the fetal condition monitor transducer 58 is fixed to the fetus, the magnetic field transducer can also be fixed to the fetus. In addition, a cable 62 is provided extending from the magnetic field transducer. This cable also carries signals from the fetal status monitor transducer 58.
The coils of the reference elements 10 and 20, the transducers incorporated in the mother probes 24 and 44, and the magnetic field transducer in the fetal probe 54 are all connected to the field transceiver 60. This field transmitter / receiver is configured to convert various component signals supplied by a magnetic field transducer into digital values. Thus, the field transceiver includes elements such as analog / digital converters, analog or digital bandpass filters and multiple signal devices. The field transceiver 60 also includes a digital / analog converter and an output amplifier for receiving digital information and converting the digital information into an electric signal that can drive the coil of the reference element 10 or 20. This field transmitting / receiving device is connected to a digital computer 62, which is connected to a display device such as a conventional cathode ray tube 64. Due to the connection between the field transceiver and the computer, the digital value of the component signal from the sensing element of each transducer is passed to the computer, and the digital value of the field supplied by the reference element coil is transferred from the computer to the field transceiver. Conventional data exchange as delivered is performed.
In operation, mother M is about to give birth on table 12. Thus, the location of the mother's pelvis is near the reference element 10 below the platform. The external mother probe 24 is fixed around the abdomen of the mother so as to be separated from each other. For example, some probes 24 are placed on the mother's abdominal wall, while one or more other external maternal probes 24a are placed elsewhere, such as the mother's back, from local movement caused by muscle contraction. Almost isolated. This isolated external matrix probe 24a is hereinafter referred to as the main external matrix probe. On the other hand, the cervical probe 44 is configured to be fixed to the uterus, and is attached to the cervix as shown in FIG. When the mother's amniotic sac is torn and her cervix expands enough to allow the fetus to pass, the fetal probe 54 is secured to the fetal scalp as shown in FIG.
Computer 62 instructs the field transceiver to drive the coil of reference element 10 and receive signals from the transducers in each of probes 24, 44 and 54. The field emanating from the coil 10 is transmitted through the space onto the probe sensor. Each sensor then provides a signal representative of the various field components at the particular location. Computer 62 receives these signals and determines the position of each probe in the reference coordinate space of reference element 10 each time a new signal is received. Note that algorithms for deriving the position of the receiving element based on the field received from the driven element by driving the transmitting element are well known in the field of magnetic positioning. Algorithms that can be used are disclosed in the aforementioned International Patent Publication No. WO 95/09562, International Patent Publication No. WO 94/04938 and US Pat. No. 5,391,199, which are incorporated herein by reference. Things are included. As disclosed in the above and other documents, the field transmitted by the coil can be a direct current (steady state) field or an alternating field of various frequencies that can be transmitted through tissue without substantial attenuation. Further, the operations of the various coils can be performed by a known time multiplexing or frequency multiplexing method. Accordingly, the selection of a specific arrangement detection algorithm and the selection of a specific coil drive sequence are not a requirement of the present invention, and any suitable algorithm that can reproduce an accurate arrangement corresponding to various sensors can be used.
As the system continues to monitor the location of the external maternal and fetal probes, the mother contracts muscles. This contraction causes the external matrix transducer 24 to move relative to the reference element 10. Therefore, the system continuously tracks the position of each external matrix probe 24 in the reference coordinate space of the reference element 10. That is, the system continuously subtracts the position of the main external matrix probe 24a to give the position of each probe 24 in the reference coordinate space of the probe 24a. As described above, the transducer 24a is mounted at a fixed location on the mother body that is substantially isolated from the mother's contraction. Therefore, the subtraction process described above replaces the position of the probe 24 with the reference coordinate space connected to the parent body, and eliminates the influence of the movement of the mother body on the table 12. In addition, the computer detects contractions by detecting the relative movement of the external maternal transducer 24. For example, the movement of any single transducer 24 relative to a transducer 24a that exceeds a certain magnitude is considered a contraction. The system also ignores movements of a shorter duration than the shortest time normally associated with a contraction and / or movements longer than the longest time typically associated with a contraction. In addition, the system ignores the movements of individual transducers 24 unless all of the transducers or a certain minimum number of transducers are accompanied by movements occurring within a particular time.
As shown in FIG. 7, the system calculates a movement vector 70 for each transducer 24 that represents the movement of the transducer from the beginning of contraction to the maximum point of movement reached during contraction. The system can provide information to the doctor via the display device 64 as, for example, a movement vector indicating each movement vector 70 ′ on the display device 64. For simplicity of illustration, only one of the separate vector representations 70 'is shown. In practice, all vectors associated with the external matrix probe can be represented simultaneously or sequentially. Furthermore, each vector is displayed in a separate reference coordinate space that can be conveniently applied to the parent reference coordinate space. For example, the mother image 72 can be displayed on the display device 64. In addition, in order to assist the direction indication in the display, the main external transducer 24a has an external indicator means (not shown) that can be visually oriented with respect to the longitudinal axis of the mother body when the transducer is applied to the mother body. Prepared). The transducer disposed in the main probe 24a is disposed in a known direction with respect to the external marker means, that is, in a known direction with respect to the longitudinal axis of the mother body. Therefore, the system can calculate the direction of each movement vector relative to the longitudinal axis of the matrix.
The system calculates a composite movement vector 74 that represents the vector sum of the movements of all external mother probes 24 relative to the main mother probe 24a. This composite vector can also be displayed on the display device 64 as an image 74 '. In addition, numerical representations of vector parameters can be displayed. In addition, the system can calculate the vector sum 80 of only the moving component 76 of the probe 24 across the longitudinal axis of the matrix. This vector representation can also be displayed on the display device 64. This vector can be used, for example, to detect anomalous contractions involving only a portion of the muscle normally involved in contractions. In addition, a scalar representation 82 of the various vector magnitudes and / or directions described above may also be displayed.
The system continues to track the position of the cervical maternal probe 44 and fetal probe 54 in the reference coordinate space with the reference element 10. Again, the system converts the position information of each probe into a reference coordinate space for the main mother probe 24a, ie, a reference coordinate space connected to the mother body. As shown in FIG. 9, the system preferably displays the cervical probe and fetal probe positions together so that the relative positions can be easily observed by medical personnel. Further, the distance D between the cervix portions 44 indicated by the image 44 'on the display device 64 indicates the degree of cervical dilation. The position of the fetal probe 54 shown in the image 54 'relative to the cervix directly indicates the position of the fetus relative to the cervix, thereby indicating the progress of childbirth. The system also calculates movement vectors for the cervical probe and fetal probe. Thus, the movement vector of the fetal probe 54 indicated by the vector display 54 "on the display device directly indicates the movement of the fetus caused by the contraction. The movement vector of the cervical probe is an external probe when calculating the composite direction of the contraction movement. It is used in addition to or in place of 24 movement vectors, and the cervical probe movement vectors resulting from the contraction are displayed directly on the screen 64.
Thus, all of the information given to medical personnel by this system allows for an improved monitoring of the delivery process. For example, abnormal contraction or increase / decrease in the magnitude of contraction can be easily detected. To further improve, the computer system can be configured to provide pattern recognition capabilities, such as, for example, recognition of specific patterns of changes in complex contractions that indicate abnormal conditions. These patterns of change can be entered directly by a physician who has experienced the observation of childbirth and the pattern of changes associated with normal and abnormal contractions. The system can also be provided with an artificial intelligence function such as a “neural network” for recognizing such a pattern. The system consists of a series of patterns of changes recorded in many births and conditions diagnosed at birth, such as normal births, off-reference fetal positions, and abnormal contractions such as retrograde contractions. With the guidance data, it is possible to educate in the conventional method of programming the neural network.
The system can be modified by removing a part of the probe. For example, the main matrix probe 24a can be omitted and the system can also calculate the position and movement vector directly in the reference coordinate space of the reference element 10. In general, the mother remains on the table 12, so that along with the rare movement of her whole, the doctor can easily ignore the pseudo contraction vector that results from the movement of the mother. The system is also based on the fact that the signal exhibits a movement that is close to a rigid body correlation between all movements of the various probes, and based on the timing of the signal indicative of the parent movement, a transducer 24 that exhibits such movement. , 44 and 54 can be eliminated. Furthermore, many of the other probes can be omitted. In the least case, useful information is obtained from only one external matrix probe and one or more reference elements. A plurality of reference elements 10 are not necessarily indispensable. As is well known in the magnetic positioning art, a single multi-axis reference element comprising a coil configured to be able to transmit along several mutually non-parallel axes is replaced by a plurality of reference elements. Can be used. Also, useful information can be obtained with only one fetal probe 54 and one or more reference elements. A single maternal cervical probe 44 can also be used to provide movement vector information. However, it is preferred to use a pair of maternal cervical probes to provide extended information.
In the above-described method, the reference element 10 fixed to the base 12 is used, and the reference element 20 attached to the frame 16 is not used. However, the reference element 20 can be used in exactly the same way as the reference element 10. Thus, although the present system has been shown as comprising a reference element 10 secured to a table and a reference element 20 secured to another set of movable frames, it may comprise only one of these sets. The position of each probe in the reference coordinate space of the reference element 20 is determined, and these positions are determined in the reference coordinate space of the main matrix probe based on the position and direction of the main probe in the reference coordinate space of the reference element 20. By converting to position, the movement of the separate probes 24, 44 and 54 can be determined. Further, the position information can be left in the reference coordinate space of the reference element 20. Even if the various vectors are displayed in any reference coordinate space, such as the reference coordinate space of reference element 20, the medical personnel can observe the direction of frame 16 and hence the reference coordinates of reference element 20. The space can be perceptually transferred into another reference coordinate space for the mother body. Further, the direction of the reference element 20 can be determined by an angle measuring device that mechanically, electromechanically, or optically detects the direction of the frame 16 with respect to a fixed position on the table 12 or the mother body. In yet another embodiment, another additional reference element (not shown) is mounted on the pedestal 12 and the position and orientation of the reference element 20 relative to the pedestal is adjusted by the reference element 20 to that additional reference element. , Or by detecting the field transmitted from it. Again, the system can convert the placement of each probe into a placement in the base reference coordinate space.
In yet another embodiment of the invention, one or more reference elements 104 can be attached directly to the mother body. For example, a reference assembly 102a carrying an array of coils or other reference element transducer 104 can be secured to the mother M at a position of the mother that is generally isolated from contraction, such as the mother's back. The positions of the external maternal probe 124, fetal probe 154, and cervical probe 144 can be detected in a reference coordinate space defined by the transducer 104 on the assembly 102a, as described above. In this case, since the reference element is directly attached to the mother body, no correction for moving the mother body is required.
The reference element can also comprise a set of reference assemblies 102. Each reference assembly includes a plurality of transducers 104 and a further transducer 106. In this case, the field is transmitted between another transducer 106 of each reference assembly 102 and the transducer 104 of the other reference assembly. As detailed in International Patent Publication No. WO 97/29685, which is incorporated herein by reference, in this system, it is transmitted by transducer 106 and received by transducer 104 of another assembly, or From this reverse field characteristic, the position and orientation of each reference assembly relative to other reference assemblies can be calculated. This information can be used directly to provide position information, which is continuously updated each time the reference assembly moves relative to one another. Thus, the reference assembly 102 serves as part or all of the external matrix transducer. In addition, if the position and orientation of the reference assembly 102 are known with respect to each other, the various reference assemblies 106 are driven to send and receive fields to and from the additional probes 124, 144 and 154. . Thus, the position and orientation of these additional transducers in the reference coordinate space defined by the reference assembly are each known. In such an arrangement, a part of the reference element is easily affected by movement caused by contraction.
Information obtained by the system of FIG. 10 can be displayed in substantially the same manner as described above. For example, the contraction vector can be formed as a composite of the movement of the reference assemblies 102b and 102c based on the reference assembly 102a and the movement of the external transducer 124 based on the reference element 102a. The contraction vector can also be calculated from the direction of movement of the transducer 124 within the composite reference coordinate space defined by all transducer assemblies.
In the system described above, the magnetic field is set from the transducer associated with the reference element and received by the transducer associated with the probe. However, the reverse arrangement can be employed. Thus, if the transducer associated with the probe can transmit the field, the transducer associated with the reference element preferably acts as a receiving transducer. The number of sensitivity directions required in the various transducers depends in part on the algorithm used to detect the position and / or orientation. For example, three independently arranged coils with axes in any known arrangement that are not collinear with each other constitute an array of reference elements and used with any transducer that exhibits sensitivity in three non-parallel directions. . Further, when the transducer on the probe shows sensitivity only in a single direction, an array of three reference element transducers each showing sensitivity in three orthogonal directions can be employed. Various combinations of the number of axes indicating sensitivity in the probe, transducer and reference element transducer can be used in a known manner.
It should be noted that the specific mechanical device for securing the various probes to the mother and fetus is merely exemplary. For example, the external mother probe can be fixed to the mother by an article that can be worn around the mother's body such as an elastic belt. Further, the external maternal probe may be provided with a clip or a suture hole for fixing to the mother's skin.
The above description illustrates a system for a human body. However, the system can be used to monitor births from other mammalian mothers. If one or more reference elements are attached to the mother, the mother can walk around and the system can operate even if the mother is not in a fixed position relative to a support such as a bed. For example, an animal mother can be equipped with the probes and reference elements described above, and the signals from those elements are relayed by telemetry. As a result, the mother can be monitored by remote control from the mother. Similarly, this system can be applied to telemetry that can remotely monitor the birth process of a human mother.
The embodiment of the present invention can also be expressed as follows.
1. (A) one or more maternal probes;
(B) means for securing the one or more maternal probes near the maternal uterus;
(C) one or more reference elements and means for holding the reference elements close to the matrix;
(D) driving the probe and reference element to transmit one or more non-ionic fields and to receive the transmitted field, each field having one reference element and one matrix probe; Transmitting means for being transmitted by one element of a pair of transmitting and receiving devices comprising and being detected by the other element of the pair;
(E) an apparatus for monitoring fetal birth from a mammalian mother comprising computing means for determining the placement of each maternal probe relative to the one or more reference elements from the detected field characteristics;
2. The apparatus of embodiment 1, wherein the means for holding the reference element near the mother is configured to hold the at least one reference element generally isolated from movement caused by the uterine contraction.
3. Means for determining a magnitude of movement of the at least one maternal probe caused by uterine contraction and supplying a contraction signal corresponding to each maternal probe representing the magnitude of movement of the maternal probe; The apparatus of claim 1 comprising:
4). Means for determining a direction of movement of the at least one maternal probe caused by uterine contraction and supplying a contraction signal corresponding to each of the maternal probes expressing the direction of movement of the maternal probe; The device according to embodiment 1, wherein
5. The calculation means determines the magnitude of movement of the at least one maternal probe caused by uterine contraction and the contraction signal corresponding to each maternal probe, and the contraction signal represents the magnitude and direction of movement of the maternal probe. Embodiment 5. The apparatus of embodiment 4 comprising means for ensuring.
6). The at least one mother probe includes a plurality of mother probes, the attachment means includes means for attaching the plurality of mother probes to spaced positions on the mother body, and the calculating means corresponds to each of the mother probes. 6. Apparatus according to embodiment 3, or embodiment 4 or embodiment 5, comprising means for providing separate contraction signals.
7. The apparatus of embodiment 6, wherein the computing means comprises means for combining the contraction signals from the plurality of transducers to provide a composite signal representing one or more parameters of uterine contraction.
8). 8. The apparatus of embodiment 7, wherein the composite signal includes data representing a magnitude of contraction and an overall direction of movement of the contraction.
9. 2. The apparatus of embodiment 1, wherein the attachment means includes means for attaching at least a portion of the maternal probe on the maternal abdominal wall.
10. The apparatus of embodiment 1, wherein the means for holding the reference element includes means for attaching the one or more reference elements to a mother body at a location isolated from uterine contractions.
11. 2. The apparatus of embodiment 1, wherein the holding means includes means for holding the one or more reference elements at least temporarily in a fixed position relative to a mother support.
12 12. The apparatus of embodiment 11, wherein the holding means includes a frame that holds the transducer and a support that holds the frame at least temporarily in a fixed position relative to a support base.
13. The apparatus according to embodiment 12, wherein the support is adjustable and the arrangement of the frame relative to the support can be arbitrarily changed.
14 12. Apparatus according to embodiment 11, wherein the attachment means includes means for securing the reference element to a support base.
15. And a fetal probe and means for fixing the fetal probe to the fetus, wherein the transmitting means drives the fetal probe and the one or more reference elements to include at least the fetal probe and one reference transducer. Means for causing one or more additional fields to be transmitted between elements of a pair of transceivers, the computing means determining the placement of the fetal probe relative to the at least one reference transducer The apparatus of embodiment 1, comprising means for:
16. 2. The apparatus of embodiment 1, wherein the at least one maternal probe includes one or more cervical maternal probes, and the securing means includes means for attaching the cervical maternal probes to the mother's cervix.
17. 17. The apparatus of embodiment 16, wherein the one or more cervical maternal probes include two or more cervical maternal probes and the calculating means includes means for calculating a distance between the cervical maternal probes.
18. (A) securing one or more maternal probes near the maternal uterus;
(B) holding one or more reference elements near the matrix;
(C) Drive the probe and reference element to transmit one or more non-ionic fields and detect the transmitted field, each field including one reference element and one matrix probe Transmitting by one element of a pair of devices to be detected by the other element of the pair;
(D) determining the placement of each maternal probe based on the one or more reference elements from the detected field characteristics, and monitoring a fetal birth from a mammalian mother.
19. 19. The method of embodiment 18, wherein the at least one reference element is held generally isolated from movement caused by uterine contraction.
20. Further comprising calculating a magnitude of movement of the at least one maternal probe caused by uterine contraction and providing a contraction signal corresponding to each maternal probe representing the magnitude of movement of the maternal probe. The method according to embodiment 18.
21. Embodiment 18 further comprising the step of calculating the direction of movement of the at least one maternal probe caused by uterine contraction and providing a contraction signal corresponding to each of the maternal probes representing the direction of movement of the maternal probe. The method described in 1.
22. The calculating step includes a step of calculating a magnitude of movement of the at least one maternal probe caused by uterine contraction, and a step of supplying a contraction signal corresponding to each maternal probe includes moving the maternal probe according to the contraction signal. 22. The method of embodiment 21 performed to represent the magnitude and direction of the.
23. The step of attaching the one or more mother probes includes the step of attaching a plurality of mother probes to spaced locations on the mother body, and the calculating step is performed to provide a separate contraction signal corresponding to each mother probe. Embodiment 23. A method according to embodiment 20 or embodiment 21 or embodiment 22.
24. 24. The method of embodiment 23, further comprising the step of combining the contraction signals from the plurality of transducers to provide a composite signal representing one or more parameters of uterine contraction.
25. 25. The method of embodiment 24, wherein the composite signal includes data representing a magnitude of contraction.
26. 25. The method of embodiment 24, wherein the composite signal includes data representing the direction of travel as a whole of contraction.
27. 24. The method of embodiment 23, wherein the plurality of maternal probes includes a plurality of cervical maternal probes and further comprising calculating a distance between the cervical maternal probes as a measure of cervical dilation.
28. (A) one or more fetal probes;
(B) means for securing the fetal probe to the fetal body;
(C) one or more reference elements and means for holding the reference elements close to the matrix;
(D) driving the fetal probe to transmit one or more non-ionic fields and to receive the transmitted fields, each field including a reference element and a fetal probe Transmitting means for being transmitted by one element of a pair of devices and being detected by the other element of the pair;
(E) an apparatus for monitoring fetal birth from a mammalian mother comprising computing means for determining the placement of each fetal probe based on the one or more reference elements from the detected field characteristics;
29. 29. The apparatus of embodiment 28, wherein the means for holding the reference element close to the mother includes means for securing the reference element to the mother.
30. And further comprising one or more mother probes and means for fixing the one or more mother probes to the mother body, wherein the transmitting means drives the mother probe and the one or more reference elements to produce one or more. Means for causing one or more additional fields to be transmitted between elements of at least one additional transceiver pair including said mother probe and one or more of said reference transducers, said calculation Embodiment 28 wherein the means comprises means for determining the position of the maternal probe relative to the at least one reference transducer and determining the position of the fetus relative to the mother based on the position of the fetal probe relative to the reference element and the maternal probe. The device described.
31. (A) fixing one or more fetal probes to the fetal body;
(B) holding one or more reference elements near the matrix;
(C) a pair of transceivers that drives the probe to transmit one or more non-ionic fields and to detect the transmitted field, each field including one reference element and one fetal probe. Sending by one element of the pair to be detected by the other element of the pair;
(D) determining the placement of each fetal probe based on the one or more reference elements from the detected field characteristics, and monitoring a fetal birth from a breastfeeding mother.
32. A fetal probe for monitoring the position of a fetus during childbirth, comprising a field transducer configured to detect or emit a non-ionic field and means for securing the field transducer to the fetus.
33. The field transducer is a magnetic field transducer, the magnetic field transducer configured to detect field components in at least two different local directions relative to the probe and provide separate data for each field component; Embodiment 33. The probe according to embodiment 32.
34. 33. The probe of embodiment 32, wherein the field transducer includes at least two coils each having a non-parallel coil axis.
35. 33. The probe of embodiment 32, further comprising a fetal heart rate monitor transducer, wherein the means for securing the field transducer to the fetus also operates to secure the fetal heart rate monitor transducer to the fetus.
These and other variations and combinations of the features set forth above may be utilized without departing from the present invention, and the description of the preferred embodiments above is exemplary and is intended to be the subject of the present invention as defined in the following claims. It does not delimit the range.
Industrial application fields
The present invention can be used in medicine and related techniques.

Claims (31)

(A) one or more maternal probes;
(B) means for securing the one or more maternal probes near the maternal uterus;
(C) one or more reference elements and means for holding the reference elements close to the matrix;
(D) driving the probe and reference element to transmit one or more non-ionic fields and to receive the transmitted field, each field having one reference element and one matrix probe; and Okuteshin means so that is transmitted by one element of a pair of transmitting and receiving apparatus and is detected by the other side elements of the pair comprising,
(E) calculating means for determining the placement of each matrix probe relative to the one or more reference elements from the detected field characteristics ;
The equipped with a device for monitoring the birth of a fetus from a mammalian mother. Wherein the reference element has means for holding near the base is composed of at least one reference element to hold the generally isolated from movement caused by uterine contractions, according to claim 1. Said calculating means determines the magnitude of movement of said at least one maternal probe caused by uterine contraction, for movement of the maternal probe sized to provide a contraction signal the corresponding to each maternal probe representing the and a means, apparatus according to claim 1. Said calculating means, means for supplying a contraction signal the determining the direction of movement of the at least one maternal probe caused by uterine contraction, corresponding to the respective base probe representing the direction of movement of the maternal probe provided by which, according to claim 1. Said computing means, to determine the contraction signal corresponding to the magnitude and the maternal probe movement of said at least one maternal probe caused by uterine contraction, represent the magnitude and direction of movement the contraction signal of the maternal probe 5. The apparatus of claim 4 , comprising means for doing so. The at least one mother probe includes a plurality of mother probes, the attachment means includes means for attaching the plurality of mother probes to spaced positions on the mother body, and the calculating means corresponds to each of the mother probes. 6. The apparatus of claim 5 , comprising means for providing separate contraction signals. It said calculating means comprises means for supplying a composite signal representing one or more parameters of the plurality of combined contraction signals from maternal probe uterine contractions, according to claim 6. It said composite signal includes data representing the general direction of movement of the size and contraction of the contraction device according to claim 7. It said mounting means includes means for attaching at least a portion of said mother probes on the abdominal wall of the mother, according to claim 1. It said means for holding the reference device comprises means for attaching said one or more reference elements to the mother where you isolated from uterine contractions, according to claim 1. Said retaining means includes means for holding at least temporarily fixed position said one or more reference elements with respect to the mother of the support apparatus of claim 1. It said holding means comprises a support for holding at least temporarily fixed position relative to the support base of the frame and the frame that holds the reference element, according to claim 11. Said support be adjustable, it is possible arbitrarily change the arrangement of the frame relative to the support stand, according to claim 12. It said mounting means includes means for securing said reference element to the support apparatus of claim 11. The fetal probe and the fetal probe further comprising a means for securing the fetus,
Said transmission means, at least one addition of one or more among the elements of the pair of transmitting and receiving apparatus including the fetal probe and the corresponding fetal probe by driving one or more reference elements and one reference element Including means for sending
It said calculating means includes means for determining the placement of the fetal probe relative to the at least one reference element, according to claim 1. Wherein comprising at least one maternal probe 1 or more cervical maternal probes, said securing means includes means for attaching the cervical maternal probes to the mother's cervix, according to claim 1. Wherein wherein one or more cervical maternal probes two or more cervical maternal probes, said computing means includes means for calculating the distance between the cervical maternal probes, according to claim 16. (A) securing one or more maternal probes near the maternal uterus;
(B) holding one or more reference elements near the matrix;
(C) Drive the probe and reference element to transmit one or more non-ionic fields and detect the transmitted field, each field including one reference element and one matrix probe a step to be detected by the other side elements of the pair are transmitted by one element of a pair of devices,
Determining a placement of each maternal probe against in (d) of the detected field said one or more reference elements from the properties of,
Methods for monitoring the birth of non-human fetus from the mother of a mammal other than human with a. It said at least one reference element is held largely isolated from movement caused by uterine contractions The method of claim 18. To calculate the magnitude of movement of said at least one maternal probe caused by uterus contraction, further comprising providing a contraction signal the corresponding to each maternal probe representing the magnitude of movement of the maternal probe, The method of claim 18. Calculate the direction of movement of said at least one maternal probe caused by uterus contraction, further comprising providing a contraction signal the corresponding to each maternal probe representing the direction of movement of the maternal probe, claim 18. The method according to 18. The calculating step includes a step of calculating a magnitude of movement of the at least one maternal probe caused by uterine contraction, and a step of supplying a contraction signal corresponding to each maternal probe includes moving the maternal probe according to the contraction signal. of performed is to represent the magnitude and direction the method of claim 21. The step of attaching the one or more mother probes includes the step of attaching a plurality of mother probes to spaced locations on the mother body, and the calculating step is performed to provide a separate contraction signal corresponding to each mother probe. the method of claim 22. By combining the contraction signals from the previous SL more maternal probes further comprising providing a composite signal representing one or more parameters of uterine contractions The method of claim 23. Including data the composite signal representing the magnitude of the shrinkage method of claim 24. Including data the composite signal representing the moving direction of the overall shrinkage The method of claim 24. The plurality of maternal probes includes a plurality of cervical maternal probes;
Further comprising the step of calculating the distance between the cervical maternal probes as an extension of the measured values of the uterus neck The method of claim 23. (A) one or more fetal probes;
(B) means for securing the fetal probe to the fetal body;
(C) one or more reference elements and means for holding the reference elements close to the matrix;
(D) driving the fetal probe to transmit one or more non-ionic fields and to receive the transmitted fields, each field including a reference element and a fetal probe a transmitting means to be detected by the other side elements of the pair are transmitted by one element of a pair of devices,
And calculating means for determining the arrangement of each fetal probe against the (e) the detected field said one or more reference elements from the properties of,
Apparatus for monitoring the birth of the fetus from the mother of a mammal comprising a. Comprising means for means for holding the reference element in the vicinity of maternal fixing the reference element on the base, according to claim 28. One or more maternal probes and the one or more maternal probes further comprising a hand stage for fixing the base,
Said transmission means of the pair of driving the with the maternal probe said one or more reference elements and at least one additional transmitting and receiving apparatus including one or more of the maternal probe and one or more of the reference element Means for causing one or more additional fields to be transmitted between the elements of
It said calculating means includes means for determining the position of the fetus to the parent on the basis of the position of the fetus probe and maternal probe the determine the placement of the maternal probe with respect to at least one reference element with respect to the reference element, 30. The apparatus of claim 28. (A) fixing one or more fetal probes to the fetal body;
(B) holding one or more reference elements near the matrix;
(C) a transmitter / receiver that drives the fetal probe to transmit one or more non-ionic fields and detect the transmitted field, each field including one reference element and one fetal probe; a step to be detected by the other side elements of the pair are transmitted by one element of the pair,
Determining a placement of each fetal probe against in (d) of the detected field said one or more reference elements from the properties of,
Methods for monitoring the birth of non-human fetus from the mother of a mammal other than human with a.

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