JPH0344783B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates generally to the medical field of urodynamic studies, and more particularly to the construction of an improved urodynamic catheter for performing urodynamic studies of the lower urinary tract. It is.

BACKGROUND OF THE INVENTION Urodynamic testing is a diagnostic procedure aimed at investigating the physiological properties of the lower urinary tract, namely the bladder and urethra.

The bladder and urethra work together as one organ to serve the dual purpose of collecting and transporting urine. The bladder is primarily composed of small muscles, many of which are under autonomic control. Muscle bundles act from layer to layer in different directions.

Urinary volume regulation in the bladder is primarily performed by the viscoelasticity of the organ. In healthy individuals, the bladder wall is able to expand as the bladder fills with urine without a significant increase in its tension. One of the main urodynamic tests is to fill the bladder with saline and measure intravesical pressure at the same time. This pressure versus volume diagram during filling is called the cystometrogram, and the first part of this volume versus pressure diagram is almost uniform in healthy individuals. When the individual signals to urinate or automatically induces urination, the pressure within the bladder increases.

Another standard urodynamic test is called the urethral pressure profile (UPP). This examination is primarily performed by inserting a catheter having a side hole and a lumen communicating therewith. The catheter is steadily withdrawn from the urethra at a nearly constant rate while diluted saline is pumped into the lumen and expelled from the side hole at a predetermined rate. along the urethra,
Obtain the UPP with a diagram of the back pressure in the line between the pump and the side hole versus the physical distance of the hole in the side wall of the pipe. Generally, when a sidewall aperture passes through a constriction, whether normal or abnormal, the back pressure increases, resulting in an upward bulge in the distance versus pressure graph. Displayed as a line.

Another predisposing factor for the above-mentioned tests is the length of the functional profile, which is essentially the length of the urethra from which the pressure profile is obtained.

One of the important parameters obtained from the urethral pressure profile (UPP) test is the maximum urethral closure pressure, which is the difference between the maximum pressure obtained by the UPP test and the internal pressure of the bladder. be.

Prior patents related to the content of the present invention are as follows.

US Pat. No. 4,136,681 to Edward H. Hong, issued January 30, 1979.

US Patent No. 168703 to Kenneth Kenigsberg, issued January 30, 19796.

No. 4,191,196 to Braddrey et al., issued March 4, 1980.

No. 4,217,911 to Terry N. Layton, issued May 5, 1981.

No. 4,252,1311 to Hong et al., issued February 24, 1981.

No. 4,006,735 to Hittmann et al., issued February 8, 1977.

No. 4,023,562 to Heinetske et al., issued May 17, 1977.

US Patent No. 3,480,003 to NA Crites, issued November 25, 1969.

No. 4,265,243 to Glenn N. Taylor, issued May 5, 1981.

U.S. Patent No. 4301811 to Terry N. Layton, issued November 24, 1981.

US Pat. No. 3,437,088 to LJ Bielinski, issued April 8, 1969.

No. 4,214,593 to Imbrus et al., issued July 29, 1980.

General Description of the Invention The present invention aims to provide an improved urodynamic catheter that can be used in performing all of the above-mentioned tests.

In particular, the present invention provides a urodynamic catheter that includes a tube having at least three lumens and one closed guiding end. A first of the lumens communicates with an aperture in a first sidewall of the tube disposed a first distance from the guide end. the second lumen communicates with an aperture in the second sidewall disposed a second distance from the guide end;
This second distance is greater than the first distance.
the third lumen communicates with an aperture in a third sidewall within the tube disposed a third distance from the guide end;
This third distance is greater than the second distance.

A variation of the catheter described above includes four lumens within the tube, which are disposed between the second side wall aperture and the third side wall aperture and are attached to the tube. It communicates with the inside of the expandable sphere.

Two embodiments of the present invention will be described below with reference to the drawings. Note that the same parts in the figures are given the same numbers.

<Detailed description of embodiments> First, FIG. 1 shows a catheter 10.
This catheter has a tube 12 and four internal passageways or lumens 14, 1, as seen in FIG.
Including 5, 16, 17. One of the lumens, designated 16 in FIG. 3, communicates with a borehole 20 having an aperture 22 in the first side wall extending slightly back from the guiding end of the tube 12. . In the illustrated embodiment, the aperture 22 extends from the guide end 24.
The distance is approximately 7mm. Aperture 22 and lumen 1
6 is utilized for filling the bladder, this aperture 22 must be located fairly close to the guiding end 24 of the catheter. The actual guiding end 24 closes all lumens.
The lid is capped by a heat-sealed closure 26 or secured to the cut-out end of the tube 12. As can be seen in the figures, the closed end 24 is rounded to facilitate insertion. The closure itself is approximately 3mm long and has a length between the actual notched end of the tube and the aperture 2.
The distance from position 2 is approximately 4 mm. Although this particular distance can be changed, the filling aperture 22
However, it will be appreciated that it is better to arrange the guide end 24 as close as possible to the guide end 24. 15 in Figure 3
A second lumen, indicated at , communicates with an aperture 28 in the second side wall of tube 12 via a borehole. This lumen 15 and aperture 28 are intended to monitor intravesical pressure as the bladder is being filled via aperture 22. As a result, a cystometry diagram is created. This figure is a diagram of intravesical pressure (intravesical pressure) against the volume of the contents of the bladder. A third lumen, designated 14 in FIG. 3, communicates with a bore having a third sidewall aperture 30 located further back from the guide end 24.

Aperture 30 is used to monitor closure pressure during cystometry. The location of the aperture 30 varies due to the different locations of the urethral sphincter in male and female patients.

Additionally, the aperture 30 and associated lumen 14
is used to construct the urethral pressure profile (hereinafter referred to as UPP), which determines the compliance along the urethral wall. As previously mentioned,
A fixed amount of saline (0.9% NaCl) is delivered through the hole where the UPP is determined, and the back pressure is measured and diagrammed for a longitudinal position along the urethra.

The last lumen, designated 17 in FIG. 3, communicates with the interior of the balloon 32 via a borehole.
The balloon is made of an expandable material and is configured to assume a roughly spherical shape when inflated. The balloon 32 has two collars 34 and 35, through which the tube 12 passes, and which are heat-sealed or secured to the tube 12 in a leak-tight manner. The balloon 32 is configured to wrap around the tube 12 when deflated so as not to become a hindrance when inserting or withdrawing the catheter. By supplying high-pressure liquid through the lumen 17, the balloon 32 is inflated, which prevents the catheter from falling during the test and allows intravesical pressure testing in an upright position. Alternatively, urinary incontinence (stress incontinence) can be detected during some tests.

During a UPP inspection, balloon 32 is placed against tube 12.
It will be understood that it contracts and deflates.

The outer or non-inserted end 3 of the tube 12
7 is connected to a plurality of small single lumen tubes 39, which are configured to be connected to various pumps, gauges, etc. used in the above-mentioned urodynamic tests. This connection is generally made by using a small coupling member embedded with four small diameter hole pins, each end of which fits snugly into one of the lumens of tube 12. It is configured for internal insertion, and the other end is configured to fit snugly within a single lumen of one of the tubes 39. Once these connections are completed, the sleeve 41 is fitted around the connector and heat sealed or otherwise secured in place. The structure of this connection position is normal,
Detailed explanation and illustration will be omitted.

Although not shown in FIG. 1, the tube 12 includes:
Markings specifically used during inspection of the UPP are placed at equal intervals along its length. Usually these markings are spaced 1 cm apart.

Referring to FIG. 2, there is shown a modification of the catheter of the present invention, which is fundamentally free of balloons 32 and is first characterized in that there are no side openings communicating with the inside of the balloon. It is different from the one shown. Another difference concerns the position of the aperture 30a. That is, in FIG. 2, its position is closer to the guide end 24a than the aperture 30 to the guide end 24 in FIG. However, as mentioned above, the location of the aperture 30 (30a) will vary depending on the patient's gender and ultimately the user's preference.

The remaining holes in FIG. 2 are designated by the same numbers as in FIG.

The tube 12 in the embodiment of FIG.
It will be seen that it is a tube with three lumens, as shown at 44 in the figure. These lumens are designated by numbers 46, 47 and 48. However, for the embodiment of FIG. 2, there is no problem in using a tube constructed of four lumens; will be closed. Generally, the tubes used in the present invention should have at least a number of lumens corresponding to the holes (including the hole for the balloon, if present), but an extra lumen should be provided. You can also see that in this case they are simply not used.

From the above description, it will be clear that two embodiments of the catheter of the present invention can be used to establish the parameters described in the introductory "Background of the Invention" section. It will further be appreciated that the lumen communicating with aperture 30 (30a) can be used to monitor closure pressure during cystometry.

In FIG. 2, a series of mark locations 50 are shown adjacent tube 12 to indicate the locations of longitudinally spaced marks used during UPP testing.

Although it is desirable to provide a reasonable idea of suitable or satisfactory dimensions for various hole spatial arrangements, these are not meant to be limiting.

In a satisfactory catheter constructed in accordance with FIG. 1, aperture 22 is located 7 mm from guide end 24, and the spacing between apertures 22 and 28 is about 1 cm. Therefore, the distance from the guide end 24 to the aperture 28 is approximately three times the distance from the guide end 24 to the aperture 22. Opening hole 22 to opening 3
The optimal distance to 0 is when the balloon 32 is placed somewhat closer to the aperture 30 than to the aperture 28.
The distance from the guide end 24 to the aperture 30 is approximately 8 cm, and the distance from the guide end 24 to the aperture 22 is approximately 8 cm.
12.4 times, approximately 5.1 times the distance from the guide end to hole 28
It will be doubled.

In the case of the catheter of FIG. 2, aperture 22 is also located approximately 7 mm from guide end 24a;
The distance between and 28 is about 1 cm, which is the same as in FIG. The distance from the opening 22 to the opening 30a is
The distance from the guide end 24a to the aperture 30a is approximately 7 cm, and the distance from the guide end 24a to the aperture 22 is approximately 7 cm.
11 times, approximately the distance from the guide end 24a to the opening 28
It is 4.5 times. Similarly, these distances will vary, inter alia, due to the fact that the location of the aperture 30 (30a) will depend to some extent on the gender of the patient as well as the preferences of the individual examiner.

Each lumen has a diameter in the range of about 0.8 mm, and the tube itself has a diameter of about 3.3 mm.

Specific embodiments of the invention are illustrated in the accompanying drawings,
Also, while described in the above disclosure, it will be apparent to those skilled in the art that changes and modifications can be made without departing from the spirit of the invention as set forth in the appended claims.

[Brief explanation of drawings]

FIG. 1 shows the first urodynamic catheter of the present invention.
FIG. 2 is a front view including a partial notch of the second embodiment; FIG. 3 is a front view including a partial notch of the second embodiment;
The figure is an enlarged sectional view taken along line 3-3 in FIG. 1, and FIG. 4 is an enlarged sectional view taken along line 4-4 in FIG. 10: Catheter, 12, 44: Tube, 14, 1
5, 16, 17, 46, 47, 48: Internal passage (inner cavity), 20: Digged hole, 22, 28, 30: Open hole, 24: Guide end, 26: Closing member, 32: Balloon, 39: Small size single lumen tube.

Claims (1)

Claims: 1. A tube having at least three lumens and one closed guiding end, a first of the lumens being spaced a first distance from the guiding end. a second one of the lumens communicates with an aperture in a first sidewall of the disposed tube, and a second of the lumens is in communication with the tube disposed a second distance from the guide end. a second sidewall aperture, the second distance being greater than the first distance, and a third of the lumens being a third distance from the guide end. The urodynamic catheter communicates with a third spaced-apart aperture in a side wall of the tube, the third distance being greater than the second distance. 2 including a fourth lumen within the tube, the fourth lumen communicating with the interior of an inflatable balloon attached to the tube, the balloon communicating with the interior of the second and third apertures; A catheter according to claim 1, which is disposed between the catheter. 3. The catheter of claim 1 or 2, wherein the second distance is approximately 2.4 times the first distance. 4. The catheter of claim 1 or 2, wherein the third distance is about 4.5 to 5.1 times the second distance. 5. The catheter of claim 1, wherein the ratio of the first, second and third distances is approximately 1:2.4:12.4. 6. The catheter of claim 2, wherein the ratio of the first, second and third distances is approximately 1:2.4:11. 7. A catheter according to claim 5 or claim 6, wherein the first distance is approximately 0.7 cm. 8. A catheter according to claim 2 or claim 6, wherein the balloon is centered at a location along the tube closer to the third term than to the second term. 9. A catheter according to any one of claims 1 to 3, wherein the guide end is closed by a rounded closure member sealing all lumens. 10. A catheter according to any one of claims 1 to 3, including markings equally spaced along the tube. 11. A catheter according to any one of claims 1 to 3, including markings spaced at equal intervals of 1 cm along the tube.