FR2504015A1 - Permanently fitted urinary catheter with external wall grooved - to spread soln. of antiseptic or antibiotic to prevent infection of urethra, bladder etc. - Google Patents

Abstract

Within the bladder, the inner end of the catheter carries an inflatable balloon piped to the exterior for inflation and deflation. The outer surface of the flexible catheter tube is formed so that it will spread a fluid between the tube surface and the inner face of the urethra. Pref. the tube surface has one or more helical grooves which be supplied with antiseptic or antibiotic solns. from an external inlet pipe. The soln. flushes the space between the catheter and the urethral passage wall and prevents infection of bladder, prostate or urethra.

Description

 The invention relates to improvements to the urinary catheters to be worn permanently (that is to say which remain in place), and it generally relates to catheters of which the type is the FOLEY catheter.

The catheter according to the invention is a catheter of the balloon type, preferably made of rubber, latex or silicone and silastic elastomer, or else of material having similar characteristics.

 Infection almost always occurs as a result of the use of permanently worn catheters, and cystitis can spread and cause a much more serious lesion, such as pyelo-nephritis or kidney infection. It is likely that the infection rises from the urethra to the bladder, then to the kidneys following the ureters. The frequency of urethritis or urethral infections) and cystitis (bladder infections) is around 4% or more.

 In fact, approximately 95% of patients with permanent catheters are affected by the development of bacteria in the urine (bacilluria) in less than four days and, in most cases, within the first 24 hours, and this infection cannot be prevented by prophylactic use of antibiotics. An even more important finding, as a result of Schneiderman's experiments, is that the bacteria go back up to the bladder through the envelope of exudate which surrounds the catheter inside the urethra.

 Another problem with using a catheter is that the urethral canal is not always sterile. Bacteria can therefore be carried from the wall of the urethra to the interior of the bladder when the catheter is inserted. This cannot be prevented by the prophylactic and local use of general antibiotics or antiseptics. Consequently, a patient permanently wearing a catheter presents a free communication allowing the passage of bacteria between the bladder cavity and the outside of the patient's body (the skin).

 Another important drawback of using the conventional catheter to be worn at all times is that the cleaning of this catheter cannot be carried out properly.

Lack of staff and / or lack of attention from staff may be the factors causing sepsis of the urethral catheter. However, even if the catheter is cleaned in the best way and even with the best urological staff, a permanently wearing catheter, maintained for a period longer than 45 hours, can cause a urethral infection which can become more serious and which can also withstand most treatments.

Since most infections caused by a catheter come from the glands of the urethral mucosa (Littre glands) surrounding the catheter, the best and, generally, the only effective way of treatment is to remove the infected catheter and treat it with appropriate antibiotics.

 Nevertheless, although it seems that good care and prophylactic cleaning can prevent infection from inside the canal, the real problem remains to be resolved, since the spread of contamination through the periphery of the catheter is very likely. Beason states that "with regard to permanently worn catheters, when there is an open channel between the bladder cavity and the surface of the body, chemical prophylaxis has no effect, as is to be expected, unless d 'eliminate sensitive organisms and promote the establishment of an infection more difficult to treat ".

 The situation described above, regarding infection due to the catheter, also arises when using catheters in the esophagus.

 The foregoing remarks and other peculiarities of possible infections make the use of catheters of the type described in this specification highly desirable.

 The invention relates to a urethral catheter which it is unnecessary to remove periodically, but which nevertheless prevents urethral infections by the fact that it is designed according to the main etiological causes of urethral infections. All male and female patients who permanently carry a catheter in their urethra are never really the object of care specially intended for the space surrounding the catheter and comprised between the urethral mucosa and the external surface of the catheter. The main reason is that so far there has not been an effective method, technique or medical instrument capable of solving this problem. The permanently worn urinary catheters described herein are designed to specifically resolve this serious problem while allowing the continuation, safely and without interruption, of urinary drainage permanently.

 The infiltration of urine into the space between the outer wall of the catheter and the urethral lining usually results from uncontrolled contractions of the expelling muscle, which often occurs in patients with neurological conditions. In the case of patients without a neurological problem, a FOLEY type catheter to be worn permanently must currently be changed frequently in order to prevent the development of incrustations, concretions (stones) and a Gram type infection. -negative with sepsis.

 The catheters described avoid having to be changed frequently in these cases, as they allow easy drainage of the glands of the urethral mucosa and, more importantly, they allow open and / or closed urethral irrigation, without interfering with the free flow of urine from the bladder. The improved catheter according to the invention promotes better drainage of the urethral glands and allows a more precise measurement of the flow rate of urine. It also prevents the formation of incrustations around the catheter in the case of catheterizations to be maintained for long periods, and it constitutes the only known catheter which allows effective local urethral irrigations with antiseptic and antibiotic solutions, by the methods of Open or closed irrigation. The catheter according to the invention does not in any way interfere with proper drainage of urine and an accurate measurement of the flow rate of urine.

The improved catheter according to the invention meets all the necessary and acceptable criteria for an effective catheter and on, to be worn permanently, the advantages and characteristics of the catheter according to the invention which can be listed as follows
1. The bladder can empty effectively and
the flow of urine can be measured with
accuracy at all times, especially at
using micrometric collectors t
2. The bladder can be irrigated with
sterile physiological saline solutions,
antiseptics or antibiotics, without
problem; sterile irrigation may be
performed separately or in combination,
that is to say in the form of an irrigation of the
urethral canal and irrigation of the
bladder, or in the form of a
combination of bladder,
prostate and urethra;
3. Any obstruction and stagnation of
secretions from the glands of the lining of
the urethra, around the catheter, are
prevented t
4. The improved catheter according to the invention
avoids having to perform catheterizations
repeated, long-lasting, which are often
favorable to infection; and
5. The perfected catheter for esophagus according to
the invention is very effective when it is
in position and it can also be used
to close the opening through which the esophagus
opens into the stomach to prevent
the introduction into the estamoc of solutions
cleaning and also to facilitate the
decompression of the stomach.

The invention will be described in more detail with reference to the accompanying drawings by way of non-limiting examples and in which
- Figure 1 is an elevation of the catheter according to the invention, showing the irrigation tube which leads to the sheath and the expansion tube which leads to the bladder
- Figure 2 is a partial axial section of the catheter, along line 2-2 of Figure 1;
- Figure 3 is a partial axial section of the catheter of Figure 1, in the area surrounded by the circle "3" in Figure 1, this section showing the balloon and the extensions of the inflation tube of the sheath;
- Figure 4 is a schematic section showing the placement of the urethral catheter to be worn permanently in the urethra of a male patient;
- Figure 5 is a schematic section showing the structure and positioning of the catheter according to the invention in the urethra of a patient
- Figure 6 is a cross section of the catheter, taken along line 6-6 of Figure 2, showing the sheath contracted tightly around the catheter;
- Figure 7 is a partial axial section of a catheter for male or female patients, showing the limited bloating of the sheath around the catheter
- Figure 8 is a cross section of the catheter, along line 8-8 of Figure 7, showing the sheath inflated under the pressure of a fluid;
- Figure 9 is a partial axial section of a variant of the catheter according to the invention, showing the presence of a two-walled sheath which allows the irrigation of the underlying outer wall of the catheter
- Figure 10 is a partial axial section of a wall of the catheter shown in Figure 9, this section showing the expansion of the sheaths during the introduction of the fluid
- Figure 11 is a partial longitudinal section showing a plug housed in the open end of the irrigation tube and the bladder tube
- Figure 12 is a partial elevation of another embodiment of the catheter according to the invention with single flow orifice and associated flow channel
- Figure 13 is a partial axial section, on an enlarged scale, showing the areas of the catheter surrounded by circles "2" in Figure 12;
- Figure 14 is a cross section of the catheter, along line 14-14 of Figure 13
- Figure 15 is a partial axial section of a wall of a catheter with several fluid vents and associated flow channels communicating with a single fluid inlet channel
- Figure 16 is an axial section, similar to that of Figure 13, but showing several fluid vents and several flow channels each connected by a flow channel associated with a common inlet;
- Figure 17 is a cross section of the catheter, along line 17-17 of Figure 16, showing the association of this catheter with the inner wall of the urinary canal
- Figure 18 is a partial elevation of a variant of the balloon catheter, intended to be introduced into an esophagus having a flow;
- Figure 19 is a partial axial section, on an enlarged scale, of the catheter section of Figure 18 having channels; and
- Figure 20 is a schematic section of the catheter of Figure 18 in the position of use in the esophagus.

 Figures 1 to 3 show an embodiment of the invention. As shown in particular in FIG. 1, the catheter comprises a tube 11 of considerable length, made of elastic material, for example of a silicone compound or any other suitable material containing latex or rubber. The tube, which is substantially analogous to the FOLEY catheter to be worn at all times, has a closed and rounded insertion end 12 and a drainage orifice 13 adjacent to this end and opening out inside the bladder 14, as shown in FIG. 7. The other end 15 of the tube is slightly enlarged so that it can be fitted telescopically onto a tube (not shown) allowing the fluid (urine) to flow from the bladder.

 The wall of the tube 11 has a channel 16 which opens, at one end, into a conventional balloon 17 adjacent to the end 12 of the tube. The channel 16 is extended along the catheter 11 and terminates in an extension 18.

When the catheter is inserted into the urethral canal 19 (Figures 7 and 8) and advanced inside. of the bladder 14, an antiseptic fluid is injected into the inlet extension 18 and enters through the channel 16 into the balloon 17 in order to inflate it and apply it to the bottom of the bladder to prevent the flow of urine as well as to fix itself in the bladder. The drainage of urine from the bladder and its flow along the outside surface of the catheter prevents the doctor from measuring the flow rate and often leads to the aforementioned formation of incrustations, concretions and, consequently, of a Gram-negative infection, followed, if necessary, by a generalized infection with sepsis, around the catheter.

 To eliminate the numerous risks presented by the flow of urine downwards, along the external surface of the catheter, the improved catheter according to the invention includes new means intended to wash its external surface and the wall 19a of the canal. urethral. These means are shown in particular in FIGS. 4 and 6 to 8.

As shown, the length of the catheter tube 11, between the point of entry (20) into the urethral canal 19 and substantially the bottom wall of the prostate 14a, is covered with an elastic sleeve 21 which is fixed to the tube 11 , preferably by fitting its ends 21a into annular recesses 22 (Figures 2 and 3) formed in the outer face of the tube, the sealing of the attachment being achieved by means of elastic bands 23 tightly tightened. The length of the sleeve between the end strips 23 is free from any restraint and can therefore, when requested, be expanded radially outward, as shown in Figures 7 and 8. The radial expansion of the sleeve 21 is obtained by the introduction of a sterile antibiotic solution or an antiseptic solution into the space provided below the sleeve 21. The fluid is introduced into this space through a channel 24 which starts from an external extension 26 comprising, at at its end, a block 27 which can be crossed (FIG. 11) in order to allow a sterile needle to penetrate in order to be able to carry out the necessary injection of the sterile fluid into the space 19 surrounding the catheter. The sleeve or sheath 21 has a large number of small perforations 29 which remain closed when the sleeve is tightened. However, when a sterile fluid is introduced into the space surrounding the catheter and when the sleeve expands, the holes open and allow the antiseptic fluid to enter the space 19 between the sleeve and the urethral wall 19a. In this way, the outer surface of the catheter tube 11, the sleeve 21 and the urethral wall 19a (Litter glands) are washed and any encrustation formed on these surfaces is dissolved and washed away. In addition, any bacteria that may have settled on the catheter before and during its insertion are eliminated by irrigation and fluid flow. As a result, the likelihood of a bladder infection (cystitis) is minimized, if not completely eliminated.

 The catheter shown in Figures 9 and 10 is substantially similar to that described above and the same reference numerals identify the same elements in the two embodiments.

 However, in this case, the catheter tube 11 has an inner sleeve 32 and an expandable outer sleeve 21 which each have a large number of small holes 29 and 29a, respectively, the holes 29a being normally closed in order to prevent introduction bacteria in the space 33 formed between the two sleeves and intended to receive a fluid. When an antiseptic solution is introduced into the space 33, the outer sleeve 21 expands in order to open the perforations 29a and to allow this antiseptic solution to wash the wall 19a of the urethral canal 19 to irrigate the outer surface of the sleeve exterior 21 and remove all debris. Some of the solution also passes through the perforations 29 in the inner sleeve 32 in order to also wash the underlying wall of the catheter.

 Another embodiment of the invention is shown in Figures 12 to 14 in which the same reference numbers as those used previously identify the same elements. As shown in particular in Figure 12, the catheter comprises a very long tube, made of elastic material similar to that described above. The tube has a rounded and closed end 12 which opens at 13 into the bladder 14.

The other end 15 of the tube is slightly enlarged so that it can be fitted telescopically onto a tube (not shown) allowing the fluid (urine) to flow from the bladder.

 The wall of the tube 11 has a channel 16 which opens, at one end, in a balloon 17 adjacent to the end 12 of the tube and which ends, at its other end, in an extension 18. The balloon is inflated, as before, by the introduction into it of a fluid) which causes the application of this balloon on the wall of the bladder.

 To eliminate the many risks resulting from the downward flow of urine along the outer surface of the catheter, the catheter shown in Figures 12-14 has new means for washing its outer surface and the wall 19a of the urethral canal. As shown in FIGS. 12 and 14, the length of the tube 11 of the catheter, between the point of entry of this tube into the urethral canal 19 and substantially the lower wall of the bladder 14, in the case of a patient being shown on Figure 5), has, in its outer surface, at least one shallow groove 34 which may be straight, helical or any other suitable shape, but which is oriented so that any fluid flows in this groove towards the outer end of the catheter. The end of the groove 34 closest to the balloon 17 communicates by a vent 35 with an axial channel 36 formed in the wall of the catheter. The channel extends from the vent 35 to an external extension 26 comprising a block 27 which can be traversed (FIGS. 11 and 12) at its end, so that it is possible to introduce a sterile needle necessary for injecting a sterile antiseptic fluid or an antibiotic fluid in the channel 36 and, consequently, in the outer groove or grooves 34. The sterile fluid tends to descend over the entire length of the channel but, during this movement, it actually spreads over the outer surface of the catheter and on the lining of the urethra, as well as on the wall of the prostatic canal. In this way, the urethral wall 19a (Littre glands) as well as the prostatic canal and the outer surface of the catheter 11 are effectively bathed, and any encrustation that may appear on these surfaces is dissolved and / or removed physically by washing, while bacteria are removed by the chemical and physical action of irrigation fluids. Therefore, the risk of bladder infection (cystitis) is minimized, if not eliminated.

 The catheter shown in Figure 15 is substantially similar to that described above and the same reference numbers identify the same elements. The only difference is that the catheter tube 11 has two outer grooves 34 which communicate with a single channel 25a through vents 35a. It is obviously possible, as indicated above, to use three or even four grooves if desired. This is shown in Figures 16 and 17. As shown, each of the grooves 37, 38 and 39 communicates with its own channel 24a, 24b and 24c, these channels joining in a common inlet channel which ends in the extension 26 whose the outer end comprises a block 27 which can be crossed.

 Although it is preferable to use elements ensuring the flow of the fluid along the grooves 34, 37, etc., these grooves can be made on the circumferential surface of the tube, without connection with a source of liquid. In this case, the fluids secreted in a natural way by the channel of the urethra tend to follow the grooves and to be distributed on all the external wall of the tube 11, 17a and on the wall of the urethral channel.

 Whatever the number and the shape of the grooves and the number of channels communicating in the catheter with these grooves, the exterior surface of the catheter and the wall 19a of the urethral canal 19 are generally bathed and irrigated, so that irrigation occurs and all bacteria and debris to be physically removed from the outer surface of the catheter and the entire canal (i.e., the prostatic and urethral mucosa).

 The catheter shown in Figures 18, 19 and 20 is intended for use in the esophagus 41 for local treatment with astringents such as adrenaline and thrombin solutions. These solutions are extruded through vents 35 (FIG. 18) coming from one or more channels 36 of the wall of the catheter Ilb, in order to penetrate one or more external grooves 34. These grooves effectively distribute the solution on the external surface of the catheter and on the inner surface of the wall of the esophagus. To prevent astringents from descending along the outer surface of the catheter and entering the stomach 42, the catheter has a balloon 17 adjacent to its lower end and which, when inflated as described above, it is applied effectively under pressure against the upper wall of the stomach and thus prevents fluids from flowing down.

 The catheter may also include means for decompressing the stomach. In this case, the section 11c of the catheter Ilb, protruding below the balloon 17, has several perforations 43 making it possible to decompress the stomach by means of a suction device fixed to the open and visible end 44 of the tube of the catheter.

 It goes without saying that numerous modifications can be made to the catheter described and shown without departing from the scope of the invention.

Claims (10)

 1. Catheter, characterized in that it comprises a flexible tubular element (11) whose external surface has means (34) intended to distribute a fluid on said external surface.  2. Catheter according to claim 1, characterized in that the external surface of the element has several helical and longitudinal grooves (34), and at least one channel (36) for fluid flow communicating with the grooves.  3. Catheter according to claim 2, characterized in that an inflatable balloon (17) is fixed near one end (12) of the tubular element.  4. Catheter according to claim 3, characterized in that the wall of the tubular element has a channel (16) which opens, at one end, into the balloon, and at its other end, into the atmosphere.  5. Catheter according to claim 4, characterized in that the channel ends in an external extension (18, 26) whose open end comprises a block (27) which can be pierced.  6. Catheter, characterized in that it comprises a flexible tube (1t) which has open inner (12) and outer (15) ends, two flexible sleeves (32, 21) telescopically mounted one on the other and on the tube and ending at a short distance from the ends of this tube, the ends of these sleeves being connected to each other and to the tube and the two sleeves being perforated over their entire useful length, elements making it possible to introduce a fluid between the sleeves in order to expand the sleeve located outside over a greater distance than the sleeve located inside.  7. Catheter, characterized in that it comprises a flexible tubular element (11) which has open inner (<12) and outer (15) ends and which forms a flow channel, a flexible sleeve (21) mounted telescopically on this tubular element and ending at a short distance from the inner and outer ends of said tubular element, this sleeve being closed at its two ends (21a) la) and the space between the tubular element and the sleeve forming a chamber intended to receive an antiseptic solution, an inlet orifice (24) making it possible to introduce said solution into the chamber and the sleeve having a large number of small perforations (29).  8. Catheter, characterized in that it comprises a flexible tubular element (11) which has an open end (12) for insertion and an open external end (15), said tubular element having a urine flow channel surrounded by a cylindrical wall of predetermined length, the outer surface of this cylindrical wall having elements (34) intended to distribute a fluid on said surface of the cylindrical wall.  9. Catheter according to claim 8, characterized in that the tubular element (11) carries an inflatable balloon (17) near its inner end (12), said cylindrical wall having a flow channel (16) which allows fluid arriving at the balloon.  10. Catheter, characterized in that it has a length of flexible tube (11) forming a single flow channel and having an outer surface which includes a groove (34) for distributing secretions of urethral glands on the wall of the urethral canal and on the outside surface of the catheter.