Patent Application
20130310710
The present invention relates to a tocodynamometer, and in particular, to a pneumatic tocodynamometer.
In clinical practice, uterine contractions during labor are measured using an external strain gauge based tocodynamometer (TOCO) and/or an intrauterine pressure catheter (IUPC). Both devices have distinct advantages and disadvantages in assessing frequency, amplitude and duration of contractile activity.
The standard for a TOCO design is the “guard-ring” style developed by Smyth et al. in the 1950s. The guard-ring TOCO comprises a strain gauge supported within a rigid ring. The strain gauge of the guard-ring TOCO has very low compliance; i.e., it does not move when force is applied. The guard-ring TOCO has the disadvantages of relatively high cost and not being disposable, although it is frequently unintentionally disposed of. Disposable TOCO's are desirable to avoid cross contamination between patients.
It is therefore desirable to provide a low cost, disposable alternative to the standard guard-ring TOCO while maintaining operational equivalence to this standard device.
The present invention is directed to a device that satisfies this need. The apparatus is a pneumatic tocodynamometer (“pTOCO”) that comprises a guard-ring with a thin elastic membrane stretched across a shallow depression, for example a spherical depression, in the center of the guard-ring. The elastic membrane traps a small volume of air in the depression. A pressure transducer may be molded into the body of the pTOCO. In an alternative embodiment, the air volume beneath the membrane of the pTOCO may be connected via a low volume air conduit to a separate pressure transducer.
In either version, it is a significant aspect of the invention that the operational response of the pTOCO is substantially equivalent to that of the standard guard-ring TOCO. This requires that the pTOCO have essentially the same physical shape, guard-ring area and pressure sensing area. Furthermore, the pressure sensing area presents stiff resistance to applied pressure. In other words, the compliance of the elastic membrane mimics the low compliance of the strain gauge of the guard-ring TOCO. Low compliance implies small displacements of the elastic membrane and small volumes of trapped air volume behind the membrane. A preferred displacement is 0.005 inches (0.0127 cm) during a normal contraction and an acceptable range of volume is from around 1 cc to 5 cc with a most preferred volume of around 1 cc or less. The invention is not limited to these displacement and volumes. Displacements and volumes are acceptable if the operational performance of the device does not substantially depart from the characteristics of the standard guard-ring TOCO.
It is therefore an object of the present invention to provide for a tocodynamometer that is less expensive to manufacture and therefore less costly than the standard strain gauge guard-ring tocodynamometer.
It is a further object of the present invention to provide for a tocodynamometer that is operationally equivalent to the standard guard-ring tocodynamometer.
It is also an object of the present invention to provide for a tocodynamometer that is disposable.
It is a still further object of the present invention to provide for a tocodynamometer that is small and lighter than current tocodynamometers to improve the comfort of the patient.
These and other features, objects and advantages of the present invention will become better understood from a consideration of the following detailed description of the preferred embodiments and appended claims in conjunction with the drawings as described following.
With reference to
With reference to
A flexible membrane 18 is stretched across the sensor body 11 of the pTOCO 10 trapping air in a very small volume. The membrane 18 may be attached to the sensor body 11 by adhesive. See
The pressure and volume characteristics are described by the ideal gas law,
PV=nRT, Eq. (1)
where P is pressure, V is volume, n is the number of moles of the gas, R is a constant, and T is the temperature. Assuming that the temperature remains constant and that there is no gas leak, the right hand side of Eq. (1) is a constant. At the pressures measured during contractions, the flexible membrane 18 moves only slightly if and only if the volume, V, is kept small. Said another way, keeping the volume small allows pressure on the membrane 18 to be transmitted to the pressure transducer 16, 17 with almost no membrane movement. The membrane 18 therefore exhibits very low mechanical compliance similar to a standard TOCO 20 and presents the same geometry to the patient. These are essential characteristics required to duplicate the performance of the standard guard-ring TOCO 20.
In the embodiment shown in
The embodiment of
A slightly modified device with extended bandwidth could serve as a maternal breathing and pulse monitor during labor. Such maternal parameters collected simultaneously with contractile events could be of great value during labor.
A prototype of the second embodiment described above used an inter-uterine pressure catheter (IUPC) transducer, manufactured by Utah Medical Products, which was connected by a 15 cm length, 1 mm diameter plastic tube 15 to the sensor body 11 shown in
A sensor body 11 similar to that shown in
It is anticipated that the pTOCO 10 may be marketed in at least the two embodiments described above: 1) disposable body 11 with embedded pressure transducer 17 and 2) disposable body 11 that is attached to reusable pressure transducer 16. In the first case, the completely disposable device would have an electrical connector cable 50 which plugs into a standard IUPC connector on fetal monitor 51. In the second case, the semi-permanent pressure transducer/amplifier 16 would plug onto the end of the standard IUPC connector and cable. The semi-permanent transducer 16 would be viewed as a one or two inch (2.54 or 5.08 cm) extension of the basic IUPC cable. The semi-permanent pressure transducer 16 could be replaced at modest cost and could be easily removed for IUPC use. The mechanical problems would be making sure that the tube does not get pinched off by the patient and that there is always an air tight connection to the pressure transducer 16. The first embodiment would be the simplest and most reliable, while the second embodiment would be the most cost effective because the pressure transducer would be reusable.
The present invention is intended to provide a low cost disposable alternative to standard guard-ring TOCO's while maintaining operational equivalence to the standard device. Several measurements and calculations were carried out to better understand the mechanical characteristics of the standard TOCO and the pTOCO. Of principle concern is the static transfer properties of the standard mechanical TOCO compared to the static transfer properties of the pTOCO.
The de facto standard tocodynamometer (TOCO) design is the “guard ring” style. This device was first described in detail in C. N. Smyth, “The Guard-Ring Tocodynamometer,” Journal of Obstetrics and Gyneacology, Vol. 64, Issue 1, pp. 59-66, February 1957. The general TOCO dimensions in Smyth's paper indicate an outside diameter of 7.5 cm, a pressure sensitive piston diameter of 2.25 cm, which is very similar to modern versions of the instrument, which may vary from 7.7 cm to 6.5 cm in diameter.
From
The modern type of TOCO 20 is about 7 cm in diameter with a 3 cm diameter strain gauge force sensor 30 at the center of a guard ring 31. Examples of prior art TOCOs are shown in
The Type 1 force sensor 30 is flat and hard, while the Type 2 force sensor 32 is slightly dimpled. The force sensor 30, 32 has very low compliance (i.e., does not move significantly when force is applied).
It is desirable that the pneumatic TOCO (pTOCO) 10 of the present invention respond in an equivalent fashion to the response of the guard-ring TOCO 20 and that it does not suffer from interferences such as maternal breathing and movement artifacts. As shown below, a pTOCO having a uniformly elastic membrane has acceptable performance up to about 10 cc of closed interior air volume, while a pTOCO having a membrane that is more rigid in the center and therefore responds in a piston-like fashion has an acceptable performance up to about 20 cc closed interior air volume. Above these volumes, interferences such as maternal breathing and movement artifacts degrade performance beyond acceptable levels, while lower air volumes tend to have better performance. While a volume below 1 cc would be desirable, 1 cc may be the lowest practically achievable for commercial purposes.
The response of a standard TOCO 20 to pressure applied to the pressure sensing area is approximately in a 6:1 ratio compared to the pressure indicated on a fetal monitor. Note that in
The displacement response of the standard TOCO 20 was determined by applying a specially fitted micrometer movement 40. The rigid pressure plate of the standard TOCO must move 9.9 mils (0.0251 cm) to produce a readout of 100 mmHg on the fetal monitor. This is approximately twice the thickness of a piece of paper. A pressure of 100 mmHg is full scale on a fetal monitor strip chart. Typical contractions would be expected to reach approximately half that amplitude, thus a nominal displacement is about 5 mils (0.005 inches) (0.0127 cm).
A tool 40 to accurately control the membrane displacement of the TOCO is shown in
To quantify the responsivity of the TOCO with respect to pressure, thin disc shaped weights were placed on the force sensing area of a standard TOCO 20 and the corresponding pressure readings indicated on the fetal monitor were recorded. The resulting curve was shifted up or down as needed so that at approximately 5 grams the output would be 10 mmHg. This is equivalent to setting the baseline at 5 grams. The process was repeated using a pTOCO prototype. The results are presented in
Since the TOCO measures the force applied to a stiff pressure plate, the average surface pressure is simply the applied weight divided by the area of the pressure plate. From the dead weight experiments, it is clear that the TOCO indicates a pressure that is almost six times the actual applied pressure. A linear regression gives Preadout=5.9*Papplied+constant. Since the pressure developed on the pressure plate of a TOCO outside the body must always be less than the pressure inside the uterus, the abdominal pressure measured by a TOCO is simply scaled by about six to give a value that is comparable to an expected inter-uterine pressure catheter IUPC measurement during labor.
The present invention is intended to reproduce the operational characteristic of a commercial guard ring TOCO 20 and where possible provide for improvement. The relevant characteristics of a standard TOCO 20 are as follows:
The commercial TOCO 20 shows some nonlinearity at low pressures, but this is not considered important or desirable. The nonlinearity of the standard TOCO 20 at low pressures is thought to be due to slack in the mechanical linkage between the contact surface and the strain gauge. These measurements are taken as representative of all commercial TOCOs but may vary from model to model. Given any one model, the methods presented here show how to design a comparable pTOCO.
The experimental results presented herein illustrate the operational characteristics of particular transducers. While other transducers may show slightly different characteristics, it is believed that the conclusions reached herein are representative of all transducers used in prior art tocodynamometers.
For a pTOCO to achieve equivalence to a standard TOCO 20, the pTOCO must have essentially the same physical shape, guard ring area, displacement and pressure sensing active area. A key point is that the pressure sensing area of a TOCO presents stiff resistance to applied pressure.
Now consider the shape an elastic sheet (membrane) would take if stretched across a circular open space of 3 cm diameter and then pressed against the abdomen of a patient in labor. If the membrane has sufficient back side air pressure, then it will remain relatively flat achieving stiff resistance to applied pressure. This is the normal operating condition desired for the pTOCO. If the back side is simply open to room air pressure, then the patient's skin will deform and extend into the open space. The extent of deformation will depend upon the properties of the elastic sheet and the maternal skin so that the exact volume displacement of the membrane 18 can only be characterized experimentally. Assume a 3 cm diameter piston shaped intrusion and assume that the membrane offers no resistance to movement. The largest practical readout during labor is about 100 mmHg. Given the 6:1 reduction in pressure at the abdomen, it is possible to compute the volumetric displacement of the membrane during a 100 mmHg event using Eq. (1). From Eq. (1),
P1V1=P2V2, Eq. (2)
where the subscripts represent the conditions before “1” and during “2” contractions. The initial pressure, P1=760 mmHg, is assumed to be atmospheric and V1 is the assumed volume. P2=P1+100 mmHg/6. The volumetric displacement of the membrane, Vd=V1−V2. Making substitutions gives:
V
d
=V
1(1−P1/P2) Eq. (3)
The average linear displacement of the membrane is then found by dividing by the circular area of the membrane, A. See
pTOCO Design Considerations
The mechanical action of the TOCO membrane is essentially the same as a spring loaded with a fixed weight which is described by Hooke's law, F=−k*x. The force is produced by pressure developed inside the uterus causing it to rock forward during a contraction which in turn develops a force on the TOCO pressure plate. One can then model output of the instrument with a linear equation:
Pm=k*x+C1, where Eq. (4)
From measurements described above, k=3.98*103 mmHg/cm. In the Smyth paper, an intrauterine pressure of 120 g/cm2 gave a displacement of 0.025 cm. Given that the density of Hg is 13.534 g/cm3, the ‘k’ for the Smyth instrument is 3.5466*103 mmHg/cm. Further the pressure actually displayed on the monitor (Pm) as defined above is proportional to the actual pressure (P) applied to the TOCO pressure plate such that
Pm=G*P+C2 Eq. (5)
From measurements made above, G=5.9. As before, C2 is an arbitrary constant set by the baseline zeroing procedure. If the analysis is limited to changes in pressure, ΔPm and ΔP, then C1 and C2 can be ignored. It is noted that Smyth did not calibrate his instrument to read out equivalent intrauterine pressure, so we do not have a ‘G’ value from Smyth's work. However, Smyth indicates that a 100 g weight placed on the 5 cm2 pressure plate, a pressure of 20 (g/cm2)=14.77 mmHg, would produce a deflection of 10 cm on 11 inch chart paper—just less than half of full scale. In our case, 14.77 mmHg would be 87% of full scale. Therefore, the value of ‘G’ that Smyth used must have been comparable. The value of ‘G’ seems to be somewhat arbitrary in that we must choose a scale factor that gives a ΔPm˜50 mmHg for a “typical” contraction which is somewhat subjective.
An amplifier will typically be required between the pneumatic tocodynamometer and the IUPC. In order to achieve operational equivalence with prior art tocodynamometers, the gain of the amplifier may be adjusted as necessary. The gains suggested herein are believed to be typical, but particular circumstances may require the gain of the amplifier to be set at different levels.
The pTOCO design must satisfy both Eq. (4) and Eq. (5) to duplicate the exact behavior of a standard TOCO. To satisfy Eq. (5), the pressure transducer amplifier is set to readout 5.9 times the applied pressure, P. Before attempting to match the performances of the pTOCO and TOCO, we need to derive basic equations that describe the behavior and to develop some critical ideas. Starting from Boyle's law, P1V1=P2V2, it is easy to show that
ΔP=P2−P1=P1(V1−V2)/V2 Eq. (6)
If we now let V2=V1−ΔV, where ΔV is the small decrease in volume (membrane deformation) caused by the applied pressure change ΔP, we find that
ΔP=P1*ΔV/(V1−ΔV) Eq. (7)
Eq. (7) can be simplified if V1>>ΔV. Therefore we solve Eq. (7) for ΔV giving
ΔV=(ΔP/(P1−ΔP))V1 Eq. (8)
P1 is taken to be atmospheric pressure, 760 mmHg. ΔP can be estimated by making the following assumptions: the normal base line procedure is followed and the monitor output is set to 10 mmHg at baseline. Then sufficient pressure is applied to the pTOCO to force a read out of 60 mmHg on the monitor strip chart, which is taken as a typical contraction. That means that ΔPm is 50 mmHg. From Eq. (5), it follows that ΔP=50/5.9 mmHg=8.47 mmHg. For typical conditions, ΔV=(0.0112) V1 showing that ΔV is only about 1% of the trapped air volume, V1. To a good approximation, Eq. (8) simplifies to
ΔP=P1*ΔV/V1 Eq. (9)
Clearly the change in volume, ΔV, is related to the amount of movement in the membrane. What is needed then is a model that relates ΔV to Δx. Two models are analyzed, a piston model and a spherical model.
Some commercial tocodynamometers are similar to the guarding tocodynamometer described by Smyth, but in these devices the pressure sensitive plate has a raised conical surface that pushes into the maternal skin by a few millimeters. The pTOCO can be adapted by gluing a conical disc to the surface of the pTOCO membrane. Optionally, the center of the pTOCO membrane can be made rigid by gluing a disc to the inside of the membrane. In either case, the modified pTOCO membrane would act like a piston—free to move at the edges, but rigid in the center. For a piston design, we can say that ΔV=A*Δx where A is the area of the rigid pTOCO membrane. Using the various equations and equating constants gives equations that describe the ‘k’ of the piston model.
k=P
1
*A*G/V
1
=P
1
*G/X
m Eq. (10a)
V
1
=P
1
*A*G/k Eq. (10b)
Letting P1=760 mmHg, A=7.07 cm2 (3 cm diameter), G=5.9, and k=3.98*103 mmHg/cm and solving for V1 gives V1=7.96 cc for the piston type membrane and the given geometry. It can be seen in Eq. (10b), that the required volume, V1, is proportional to the area, A, and is therefore dependent upon the selected geometry. Equation (10a) includes the term Xm, where Xm=(V1/A) is the mean depth of the trapped air volume behind the unloaded pTOCO membrane. For the stated values, Xm=1.126 cm.
The above values for Xm and V1 are maximum values for acceptable performance for the stated case. Smyth's criteria is that the membrane displacement be limited (Δx<=0.025 cm), which is accomplished by setting the value of ‘k’ for the expected pressures. However, there is no lower bound on the displacement, Δx. Making Xm and V1 small increases ‘k’ and therefore minimizes the displacement Δx.
The effects of the elastic properties of the membrane can now be analyzed. The membrane requires force to displace and as such has a ‘k’ value. For a pTOCO the ‘k’ for the membrane simply adds to the ‘k’ due to ΔP. The equation that describes the system is
k
pTOCO
=k
membrane
+k
air where, Eq. (11)
What we see is that the effect of the membrane is to make the membrane ‘stiffer’ as compared to the stiffness due to the trapped air acting alone. If kmembrane˜kair, the consequence is that for a given applied ΔP at the membrane the resulting Δx is smaller than expected which in turn produces a smaller ΔV and therefore a smaller than expected ΔP at the pressure sensor. To compensate for a stiff membrane, one must simply increase the gain, G. It is desirable to maximize kair by making V1 as small as practical. This reduces the effect of the membrane and maximizes the pressure delivered to the pressure sensor. As a design check, if the G needed for the pTOCO is found to be 5.9, then the membrane stiffness must be insignificant with respect to the stiffness presented by the trapped air volume.
Without an exact model of maternal tissue and the application of finite element software, there is no practical way to compute exactly how the pTOCO membrane deforms during a contraction. We employ a spherical model as an approximation. This assumption gives a more realistic model to work with than assuming a rigid membrane. The spherical model gives
ΔV=πh2(3r−h)/3, where Eq. (12)
As a further constraint, the edge of the volume Vd must be 3 cm wide. This gives the following constraining equation with units in cm:
r
2=(3/2)2+(r−h)2 Eq. (13)
It is straightforward to expand the right hand side of Eq. (13) and solve for the radius, ‘r’.
r=((3/2)2+h2)/(2h) Eq. (14)
Then Eq. (14) can be substituted into Eq. (12) to eliminate ‘r’, giving:
ΔV=πh(3(3/2)2+h2)/6=3.5343*h+0.5236*h3 Eq. (15)
If the central depression, h, is limited to a maximum of 0.025 cm, then the h3 term is at least four orders of magnitude smaller than the first term and for a 3 cm wide spherical depression, we have
ΔV=3.5343*h Eq. (16)
For a displacement, h, at the center of the membrane, the volume, ΔV, is half that of the piston model for the same displacement. Following the same process as for Eq. (8a) and Eq. (8b), the relationship between ‘k’ and V1 for the spherical model is given by
k=3.5(cm2)*P1*G/V1=0.5*P1*G/Xm Eq. (17a)
V
1=3.5(cm2)*P1*G/k Eq. (17b)
As before, letting P1=760 mmHg, 3 cm diameter membrane spherical model, G=5.9, and k=3.98*103 mmHg/cm and solving for V1 gives V1=3.98 cm3 for the spherical model and the given geometry. Eq. (17a) includes the term Xm, where Xm=(V1/A) is the mean depth of the trapped air volume behind the unloaded pTOCO membrane. For the stated values, Xm=0.563 cm.
The minimum practical trapped air volume for the 3 cm diameter membrane is about 1 cc and is the favored implementation. Assume that the trapped volume V1=1 cm3 and ΔP=8.47 mmHg as before, then ΔV=0.0111 cm3. Using Eq. (16), h=0.003153 cm=1.242 mils for the given conditions and k=1.585*104 mmHg/cm which indicates that the pTOCO membrane is about 3.9 times stiffer that the example TOCO.
A 10 cc and a 100 cc prototype using uniformly elastic membranes were tested on five patients. The 100 cc prototype never produced a usable signal while the 10 cc did. Though not statistically verified, the 10 cc prototype trace appeared to be lower in amplitude and more sensitive to maternal movements such as breathing as compared to 1 cc pTOCO and standard TOCO.
The mean depth behind the membrane, Xm, is equal to the total trapped volume (including air in connecting tubing and pressure sensor) divided by membrane area. It was shown that Xm is the primary parameter of determining responsivity and not total volume, V1. The 100 cc prototype TOCO was not functional with Xm=14.147 cm.
It is understood that the pTOCO membrane cannot have precisely the same characteristics as the stiff plate of the standard TOCO. A realistic spherical model was developed for analysis of the membrane displacement. Assuming a spherical model where the central displacement matches the displacement of the standard TOCO 20, gives Xm on the order of 0.563 cm (V1=3.98 cc). This establishes what is likely to be the largest acceptable volume for a pTOCO with 3 cm diameter membrane.
If the membrane is to be made as stiff as possible, then the volume, V1, must be minimized. We have demonstrated a V1=1 cc prototype, which gives Xm=0.1415 cm. The latter case is the most desirable for the following reasons: maximum flatness of the membrane, less membrane tension (less error), and minimum Xm that makes possible a thin tocodynamometer.
Only the 1 cc pTOCO rejected maternal movement artifacts as well as the standard TOCO, while both the 1 cc and 10 cc have similar responsivity. This implies that membrane stiffness is essential for artifact free measurement of maternal contractions. The integration of the concept of a pTOCO with the guard-ring TOCO geometry is essential for FDA (U.S. Food and Drug Administration) equivalency. Achieving artifact free equivalence would limit the Xm to about 0.56 cm or less (˜4 cc volume). Further, it appears that simply having a small volume pTOCO is not equivalent to small volume plus guard-ring.
As noted above, the response of a standard TOCO 20 to pressure applied to the pressure sensing area is approximately in a 6:1 ratio compared to the pressure indicated on a fetal monitor. Note that in
Volume and Displacement in 10 cc and 100 cc Prototypes
To study the effect of volume on the response of the pTOCO, a combination 10 cc or 100 cc volume tocodynamometer was constructed for testing. This prototype is the same diameter as the original 1 cc volume prototype and has the same 3 cm diameter membrane material. The 10 cc prototype was fitted with a large syringe set to 90 cc volume. A “T” connection was placed in the tubing linking the 10 cc pTOCO to the pressure transducer and the syringe was tied into the “T” connection. A clamp was placed between the syringe and the “T” so that if the clamp is closed the volume is ˜10 cc and if the clamp is open the volume is ˜100 cc. The first case will be referred to as the 10 cc pTOCO and the second case as the 100 cc pTOCO.
From the above measurements, it is clear that the trapped air volume of the pTOCO affects the responsivity of the system for a given membrane displacement. It would be desirable to duplicate the behavior of a commercial tocodynamometer. A 100 mmHg change in pressure should correspond to about 9.9 mil (0.25 mm) change in membrane position. For comparison, a sheet of paper is typically 4 mils (0.1 mm) thick. For an air based pTOCO, the following formula holds:
dP=−P
1(dV/V1)/(1+(dV/V1)), Eq. (18)
The way Eq. (18) is cast makes it clear that the relevant parameter is the percent change in volume (dV/V1). In this case, we do not make the simplification of Eq. (9). If we assume that the pressure sensing area is stiff so that the membrane acts like a piston, as is the case for the commercial TOCO, then we can say something about the equivalent thickness of the trapped air volume. Eq. (18) can then be modified to express dP as a function of displacement. Let Xm=V1/A so that V1=A*Xm and dV=A*dX where A is the area of the membrane (cm2) and Xm is the average depth of the volume behind the membrane. It must be noted that this “average depth” volume would include the volume of tubing used to connect to the pressure transducers and similar volumes not immediately behind the membrane. Eq. (18) reduces to:
dP=−P
1(dX/Xm)/(1+(dX/Xm)) Eq. (19)
The elastic membrane acts as a piston so that the volume displaced by the membrane can be considered to be a disc shaped volume. As shown above, the displacement of the transducer plate of a standard TOCO is typically 9.9 mills (0.0251 cm) for a 100 mmHg readout. For a 100 mmHg readout, the actual applied pressure is about ⅙ of 100 mmHg which is 16.67 mmHg. Assuming dP=16.67 mmHg, dX=−0.0251 cm, and P1=760 mmHg one gets Xm=1.17 cm from Eq. (19). Then Xm=1.17 cm times 7.07 cm2 gives a volume of 8.27 cc.
Let the center of the 3 cm diameter membrane move 9.9 mills (0.0251 cm), then by Eq. (15) we have Vd=0.0889 cm3. V1 can be found by using Eq. (18) using dV=−Vd, dP=100/6=16.67 mmHg, and P1=760 mmHg. From Eq. (18), V1=4.14 cm3. Also the average thickness would be Xm=4.14 cm3/7.07 cm2=0.563 cm.
If we assume that the membrane is as “stiff” as possible, the volume V1 should simply be minimized. We have demonstrated that a volume of approximately 1 cm3 is possible to achieve. If V1=1 cm3, P1=760 mmHg, and dP=16.67 mmHg, then dV=−0.0215 cm3. Assuming a piston movement, the displacement would be dX=0.003 cm and assuming the more realistic spherical model, h=0.0061 cm. In either case, Xm=V1/7.07=0.1415 cm. Given the 3 cm diameter membrane used in the prototypes, the area “A” is 0.07 cm2. For volumes of 1 cc, 10 cc, and 100 cc, Xm is 0.145 cm, 1.45 cm, and 14.5 cm respectively. There is a practical limit to the area A, however, the range of volumes that have the same dX/Xm can be quite large.
A number of tests were undertaken to evaluate the effectiveness of the 10 cc versus the 100 cc pTOCO keeping the general dimensions of the 1 cc pTOCO (7 cm diameter body and 3 cm diameter membrane). Five sets of data were recorded with the 10 cc volume and 100 cc volume (clamp closed, then open). The protocol called for the pTOCO to be placed on the patient and baseline set in 10 cc mode. After recording, the clamp was opened and the baseline was reset. Recordings were nominally 1200 seconds. The general result was that the 10 cc pTOCO recorded contractions, but displayed 1) much more maternal breathing and 2) more movement artifacts than a standard TOCO or the 1 cc pTOCO. Five recordings did not provide sufficient data for statistical analysis, but the impression is that the magnitude response is reduced somewhat comparing the 1 cc pTOCO to the 10 cc pTOCO. The lack of response from the 100 cc pTOCO was obvious. An example of 10 cc pTOCO versus 100 cc pTOCO is shown in
There are 4 million births each year in the U.S.A. alone. Adding the industrialized countries where the product would enjoy patent protection would easily double that potential. The second version may be very appealing in cost sensitive situations. All components can be mass produced, including the pressure transducer, at prices comparable to standard disposable IUPC devices.
The present invention has been described with reference to certain preferred and alternative embodiments that are intended to be exemplary only and not limiting to the full scope of the present invention as set forth in the appended claims. The disclosure of U.S. Provisional Application No. 61/462,811 filed 8 February 2011 is hereby incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/US2012/000058 | 2/3/2012 | WO | 00 | 7/25/2013 |
| Number | Date | Country | |
|---|---|---|---|
| 61462811 | Feb 2011 | US |
