FR2673524A1 - Anorectal manometry probe with three balloons, and insufflation and measurement device for its operation - Google Patents

Abstract

The invention relates to an inexpensive device which makes it possible to perform, on outpatients both in general practice and in hospitals, the diagnosis and re-education of disorders of the lower digestive tract, in a simple and reliable manner. It consists of an anorectal probe (1) comprising a distal/rectal balloon (3), a balloon for the anal internal sphincter (4), a balloon for the anal external sphincter (5) and four connection catheters which supply in each case (2a) (3a) (4a) (5a) an independent insufflation conduit, of which one (2a) gives direct access, via the distal end (2) of the probe, to the sigmoid colon, that is to say the lower intestine. This probe is associated with a measurement apparatus comprising air insufflation means. Syringe (6) and valve pear (11), in the conduits (2a) (3a) (4a) (5a), which are controlled by switches (7) (8) (10) (12) (13), the appropriate operation of which permits measurements of air volumes, pressures and pressure variations, in particular a manometer (9).

Description

ANO-RECTAL MANOMETRY CAPTURE PROBE
WITH THREE BALLOONS
The present invention relates to an anorectal sensing probe which, associated with a measuring device, makes it possible to carry out a complete dynamic sigmoido-recto-anal assessment by manometry. This anorectal probe has three inflatable balloons and four connection catheters which each supply an autonomous insufflation duct
The present invention will be better understood from the detailed description which follows of a preferred embodiment with reference to the appended drawing, given by way of illustration, comprising FIG. 1 and FIG. 2.

 For its use, the probe which is the subject of the invention is placed gently in the patient's rectum and has for its object the diagnosis and rehabilitation of the rectal cavity and of the internal and external sphincters of the anus; sterilizable and easy to use, it provides an important aid in determining the examinations necessary for a patient.

In the current state of medical technology relating to anorectal manometry, which highlights the anomalies of the terminal digestive system and makes it possible to diagnose the origin of defecation disorders, existing devices include operating instructions. complex, are knives, do not allow to practice in i ..

outpatient medicine and can be used for other types of exams. In addition, there are devices that allow only functional rehabilitation of the perineum by biofeebak.

The probe object of the invention can be used for both diagnosis and rehabilitation; in addition, the invention relates to a measuring device which is associated with it and which authorizes, according to a precise operating mode, both rehabilitation and diagnosis. Finally, the probe object of the invention has the characteristic of allowing siqmoidian insufflation which allows the complete dynamic siqmoido-recto-anal assessment which the practitioner needs in any analysis of defecation disorders and anomalies of the rectal cavity and the sphincter muscles of the anus.

According to the invention, the aforesaid probe consists of a flexible central cylindrical tube (1) of 0.006 to 0.007 m in cross section which, from its active rectal end (2), is covered with a latex envelope of a total length of 0.13 m, the said latex envelope decomposing into three independent successive balls, the one closest to the active end being called the distal / rectal balloon (3) and having a length of about 0, 08m, the balloon adjacent to it being called the balloon of the internal anal sphincter
(4), and the third balloon adjacent to the previous one and of exactly the same shape and size being called the balloon of the external anal sphincter (5).

According to the invention, each of the three aforementioned balloons forms a sealed pocket, of cylindrical section, each inflatable separately and independently by an autonomous insufflation duct which runs in the flexible cylindrical tube (1) mentioned above and leads respectively in each balloon. Each insufflation duct (3a) (4a) (5a) is autonomous and supplies a single balloon, respectively the # distal / rectal balloon (3), that of the anal internal sphincter (and that of the anal external sphincter ( 5).

 According to the invention, the flexible cylindrical tube (1) of 0.006 to 0.007 m in section contains a fourth insufflation tube (2a) which terminates at the rectal end (2) of the probe device, and the function is to breathe air directly into the patient's sigmoid, which makes it possible to measure the sigmoid sensitivity and pain thresholds. The air blowing into the duct (2a) is obtained by means of the bulb a tap (it) and by the appropriate manipulation of the switch (13). The measurement of these thresholds constitutes the first diagnostic element provided by the probe, object of this invention.

According to the invention, the distal / rectal balloon (3) is mounted on the central cylindrical tube, near the end of the probe and adjacent to the balloon of the internal anal sphicter (4), which is adjacent to the balloon of the sphincter. external anal (5).

It is indeed important that when the distal / rectal balloon is inflated by means of compressed air, it completely hugs the walls of the patient's rectum in order to validate
volume and pressure measurements that are allowed by the probe. This is the exact reason why the distal / rectal balloon (3) has a length of 0.08 m and is completely adjacent to the balloon of the internal anal sphincter (4); similarly, the latter is separated from the balloon of the external anal sphincter (5) by a distance of 0.02 m; thus, when these last two balloons are inflated, they are located at the two ends of the anal canal with a spacing which ensures perfect positioning and blocking of the probe both in the rectum and at the level of the anal canal, since the actual effective length of the anal canal is 0.03 to 0.04 rn.

By this advantageous arrangement, the pressure measurements carried out on the internal and external sphincters are repetitive and reliable, since the probe is perfectly blocked in good functional position and will not undergo any displacement which could alter the measurements, during the diagnosis as during the rehabilitation. of the patient; indeed,
the elasitically deformable distal / rectal balloon is in close contact with the entire rectal cavity when it is
inflated, which allows an exact transmission to the mano-
meter (9) of the pressures exerted on this ball.

According to the invention, the distal / rectal balloon (3) can be
inflated with compressed air using the conduit
insufflation (a) which connects the balloon to the catheter
correspondent; blowing air through this catheter using
a graduated syringe (6) to measure compliance
patient's rectal and thus know the
sensitivity, exemption and pain that characterize it.

This insufflation of variable and controlled air volumes
is achieved by proper handling of the switch
(7) and the graduated syringe (6).

The measurement of these three thresholds, expressed in volume values
compared to a standard established for a normal individual,
constitutes the second diagnostic element brought by the probe,
object of the invention.

According to the invention, when the distral / rectal balloon (3) has received
through its insufflation duct (3a) the quantity of air which
exerts pressure on the patient's rectum which
corresponds to the above exemption threshold calculated in volume,
the communication, by the appropriate manipulation of switches (7) and C8), of the distalfrectal balloon with a
pressure gauge (9) will measure this pressure
... / ...

after which, i 1 will be asked the patient to exert a strong
thrust intended to provoke the simulation of an exemption,
which thrust will be directly read on the pressure gauge (9) by
differential measurement ie of pressures by means of displacement of the needle on a scale graduated in mbar.

 The measurement of this pressure differential at the level of the rectum constitutes the third diagnostic element and an element of rehabilitation brought by the probe, object of the invention.

According to the invention, it is then possible to empty the distal / rectal balloon and to send air thanks to the appropriate manipulation of the switch Z0), by means of the pair with tap <11) by the conduit of appropriate insufflation (4a), into the balloon of the anal internal sphincter (4) until
the patient feels the inflation of the balloon; the pressure, # known as rest, exerted by the
internal sphincter at rest and then the new pressure, called contraction, which will register on the pressure gauge when the
patient ve strongly contract his anal sphincter muscle.

According to the invention, in the same way, after having emptied the
balloon of the internal sphincter, it will be possible to send
the air, thanks to the manipulation of the switch (12),
tap eirp means (in the balloon of the external anal sphincter (5) by means of the insufflation duct (5a)
until the patient feels the swelling of the
balloon we then directly measure the pressure exerted by the external sphincter at rest, then the new pressure which goes
register on the pressure gauge when the patient contracts
again strongly his anal sphincter muscle.

The measurement of these different pressure values
sphincter muscles is a new diagnostic element and
of rehabilitation brought by the probe object of the invention.

According to the invention, after emptying the sphincter balloon
external anal (5), it is possible to re-send air through the baller via the appropriate insufflation duct (4a)
of the internal anal sphincter until an indication of pressure on the pressure gauge (9) slightly higher than the
so-called rest pressure, which was mentioned above, -
then send, through the appropriate manipulation of the switch (7), air into the insufflation duct
appropriate (3a) of the distal / rectal balloon (3); when the
quantity of air sent into this balloon corresponds to the volume which
causes the desire for exemption, we observe and measure
directly by the graduated manometer (9) the fall of the 3
pressure exerted by the internal anal sphincter on the ball
corresponding (4), which gives the value of the recto-anal inhibitory reflex expressed in bar. The measure of this
reflex constitutes an additional element of diagnosis and
of rehabilitation brought by the probe object of the invention.

 According to the invention, the probe, in its part constructed around the flexible central cylindrical tube (1), measures a total length of 0.40 m, and is extended by four independent catheters, themselves of a length of approximately 0 , 50 m, which can be plugged in, thanks to a simple numbering device, on the four outputs of a box comprising a pressure gauge dial, five switches and two inputs.

According to the invention, the two inputs are intended to select the air intake coming from one of a tap bulb (11), for 1 second from a syringe (6) graduated in ml, and the five switches are intended to authorize or prohibit the admission of air into the four catheters which lead to the insufflation ducts (2a) (3a) (4a) (Sa), as well as to put in closed circuit the different balloons with the manometer (9), when it comes to measuring pressures or pressure variations.

Claims (8)

!) Sealed anorectal sensing probe with three inflatable balloons, characterized in that it comprises a distal / rectal balloon (3) and two sphincter balloons (4) (5) all three secured to a tube (1) which passes through them and ends at the distal end (2) of the probe 2) rectal probe according to claim 1 characterized in that the distal / rectal balloon (3) is cylindrical and has in the undeformed state a diameter of about 0.018 m and a length of 0.08 m, and qu '' it includes an autonomous insufflation duct (3a) d intended for the delivery of compressed air 3) rectal probe according to claims 1 and 2, characterized in that the ball Ion of the internal anal sphincter (4) is immediately adjacent to the distal / rectal balloon (3) has a diameter of 0.012 mm and a length of approximately 0.01m, and that it comprises an autonomous insufflation duct (4a) intended for sending compressed air. 4) Rectal probe according to claims 1,2 and 3, characterized in that the balloon of the external anal sphincter (5) is immediately adjacent to the balloon of the sphincter .1 ...  internal anal (4), has a diameter of 0.012 m and a length of about 0.01 m, and that it comprises an autonomous insufflation duct (5a) intended for the delivery of compressed air. 5) rectal probe according to claims 1, 2, 3 and 4, characterized in that the total device of the probe is made of latex, has a length of 0.13 m, exactly adapted to the human organism, in that the spacing between the two sphincter balloons is such that the anal canal is either exactly taken between these two balloons (4) and (S), and that their positioning blocks the entire probe in good position in the rectum, all the more more than the distal / rectal balloon (3) occupies the entire space of the rectum when inflated 6) rectal probe according to claims 1, 2, 3, 4 and 5, characterized in that it comprises an autonomous insufflation duct 82a) which passes through the entire probe 17 inside the tube (1) and terminates at the rectal end (2) thereof, which is intended to inject compressed air 17 directly into the patient's sigmoid.  ... .... 7) Insufflation and measurement device usable on an outpatient basis for the implementation of the salt probe any one of claims 1 to 6, and characterized in that it comprises a syringe (6) and a worse valve (which are air blowing means, the pair with tap  (11), to which is associated a pressure gauge (9) for measuring pressures and pressure variations, being connected to the four supply ducts (3a) (4a) (Sa) (2a), on each of which is arranged respectively a switch (8) (10) (12) (13) communicating the pair and the corresponding insufflation duct, and the syringe (6), downstream of which is disposed a switch  (7) being connected to the insufflation duct (3a) downstream of its switch (8) relative to the pair (11) and supplying the distal / rectal balloon (3) with measurable air volumes. 8) Application of the rectal probe according to claims t, 2, 3, 4, 5, 6 and 7 in the diagnosis and rehabilitation of various diseases concerning the lower intestine, the rectum and the anal canal.