Catheter

Abstract

A catheter for urinary and other purposes is disclosed, comprising means forming an elongated flexible conduit having an insertion end, the conduit also having a distal end spaced from the insertion end. Means are provided forming a protective sheath extending in continuous form from the insertion end toward the area of the distal end, and maintaining a substantially sterile condition on the entire outer surface of the conduit. The protective sheath may be a pair of telescopically-arranged tubes, or may be an accordion pleated light-weight material, for example. Catheters of this type may be provided for intermittent use or as indwelling catheters.

Description

BRIEF DESCRIPTION OF THE INVENTION

This invention relates to a catheter having special construction features providing for protection of the patient against infection. More particularly, this invention relates to a catheter of the urinary type, which is used in large numbers by practitioners of rehabilitation medicine, particularly in the care of patients who have suffered spinal injury or strokes or are otherwise unable to control muscular functions.

In some instances a catheter of the intermittent type is prescribed, in which situation the catheter may be subjected to a single use and then discarded. In other situations, the catheter is allowed to remain within the patient's body for several days or more, with substantially continuous drainage of body fluid into a collector. This invention relates to catheters of a highly useful form, as compared to catheters of the prior art.

DISCUSSION OF THE PRIOR ART

One of the most serious problems in the use of indwelling catheters, particularly indwelling urinary catheters, is the problem of infection. When a urinary catheter is allowed to remain in the patient`s bladder for a period as long as 4 days or more, substantially every patient contracts a bladder infection, particularly when the patient is situated in a hospital environment.

Although various proposals have been made in the past to provide protection for such catheters, and various bacteriostats and bactericides have been applied to the surfaces of urinary catheters in order to prevent infection, none of these in my experience have been completely effective and the danger of infection is always present, particularly in the case of indwelling catheters.

Although a system called a "closed drainage system" is sometimes used, and has lengthened the time before the patient becomes infected, it does not address itself to the theoretical and actual modes of urinary tract infections as a result of catheter utilization.

Contrary to current thought, it has now been discovered that contamination of a catheter which is used continuously, or intermittently as well, is a source of morbidity and a risk to the patient.

OBJECTS OF THE INVENTION

It is accordingly an object of this invention to provide a catheter which may readily be used by the attending physician or even by the patient himself or herself, without subjecting the patient to any substantial risk of infection. Another object of this invention is to provide a catheter wherein the surfaces of the catheter tube that is inserted into the patient's body are completely protected from bacterial invasion, not only during the period of insertion but also during the period of actual use.

Other objects and advantages of this invention, including the simplicity of the same and the ease of its operation, will further become apparent hereinafter and in the drawings, of which:

FIG. 1 is a view in perspective of a catheter comprising one form of this invention, particularly adapted for intermittent use;

FIG. 2 is a longitudinal sectional view of the catheter of FIG. 1;

FIG. 3 is an enlarged view of the end portion of the catheter of FIG. 2, showing the manner of its insertion into the patient's body;

FIG. 4 is a longitudinal view, partially in section, showing a catheter of the indwelling type, in accordance with this invention;

FIG. 5 is a view of the end portion of the catheter of FIG. 4, showing the manner of its insertion into and connection to the patient's body, and;

FIG. 6 is a view in longitudinal elevation, showing a still further form of catheter, which is particularly adapted for use as an intermittent catheter.

DETAILED DESCRIPTION OF THE INVENTION

In the description that follows, specific terms will be used in describing specific forms of the catheter, as shown in the drawings. The use of such specific terms is not intended to limit the scope of this invention, which is defined in the appended claims.

Turning now to FIG. 1 of the drawing, the number 10 designates a conduit which has the shape of an elongated tube, usually made of rubber or plastic, which is intended to be inserted into a passage in the patient's body, such as insertion into the urethra or trachea, for example. The conduit 10 has an insertion end 11 and a distal end 12 through which the body fluid is discharged.

A protective tube 13 extends beyond the insertion end 11 of the conduit 10, but terminates at an end portion 14 along the length of the conduit 10. Another protective tube 15 is sealed to the conduit 10 at a point near its distal end 12, and extends in telescoping relationship within the end portion 14 of the protective tube 13 to form an extendible and retractable protective sheath over the conduit 10. Thus, even before the catheter is inserted into the patient's body, a telescopic overlap occurs between the tubes 13 and 15 in the area 16 which appears in FIGS. 1 and 2 of the drawings.

Further referring to FIGS. 1 and 2, a light-weight flexible material, shown as having a collapsible accordion-pleat configuration, comprises a supplemental extendible and retractable protective sheath 20 which is secured at one end to the tube 13, which bridges across the telescopic portion 16, and is secured to the other tube 15 at the other end of the supplemental sheath 20. Although the supplemental sheet 20 is shown with accordion-pleats 21, it may have any form at all, so long as it is longitudinally collapsible in a manner to allow the tubes 15, 13 to telescope.

As shown in FIG. 2, the insertion end 11 of the conduit 10 is located within a dilator portion 22 of the tube 13, which extends beyond the end of the insertion end 11 of conduit 10. As shown in FIG. 1, a sealing cap 23 is provided to cover, seal and lubricate the dilator 22.

In the operation of the apparatus appearing in FIGS. 1 to 3, the physician (or even the patient himself) removes the sealing cap 23 and inserts the dilator 22 into the patient's body, such as the meatus. Holding the tube 13 on one hand and the tube 15 in the other hand, he slides the tube 15 within the tube 13. Preferably, one or both of the tubes 13, 15 are quite rigid so that they may be telescoped (even by a patient whose neuromuscular control or skeletal alignment is poor) without substantially bending or kinking the conduit 10. Since the tube 15 is connected to the conduit 10, the entire conduit 10 slides longitudinally through the tube 13, through the meatal dilator 22 and into the urethra and ultimately into the bladder, for example. Urinary fluid thus released from the bladder flows out through the distal end 12 of the catheter.

Since the catheter of FIGS. 1 to 3 is intended primarily for intermittent use, the usual practice, after all of the fluid has been drained, is to simply withdraw the tube 15 telescopically rearwardly through the tube 13 until the insertion end 11 of the catheter conduit 10 has been withdrawn completely from the patient's body. The catheter may be discarded or cleaned, re-sterilized and re-used.

FIGS. 4 and 5 show a modified form of the apparatus, intended for indwelling use. The number 30 designates the conduit having an insertion end 31 for insertion into the patient's body. The distal end 32 of the conduit 30 is formed integrally with a collecting bag 33 and is sealed thereto. Extending all the way from the bag to the insertion end 31 is an extendible and retractable protective sheath 34, which again has been shown as having accordion-pleats. 35. The protective sheath 34 is sealed to a plug 36 which carries a rolled-up, flexible tube or sheath of rubber or the like 37 sealingly secured to its end.

FIG. 5 shows the manner of insertion of the catheter into the patient's body, with the sheath 37 unrolled and forming an anchor and a seal to the patient's body, while the conduit 30 is inserted into the urethra or other body passage, sealed completely from bacterial invasion from outside by the plug 36 and by the protective sheath 34. In the act of insertion, the bag is moved toward the patient's body, sliding the entire conduit 30 in the same direction while the collapsing of the protective sheath 34 permits such movement without interfering with the integrity of the protective seal.

Since the catheter of FIGS. 4 and 5 is intended for indwelling use, it is often provided with a balloon, not shown, which is of the usual type and which is well known per se, and which is inflated in order to form an anchoring means within the bladder, once the catheter has been inserted into the bladder.

In indwelling use, it will be appreciated that fluids are substantially continuously being drained from the body, and that the bag 33 is being filled on a continuous basis. Accordingly, a valve 40 is provided for the occassional removal of collected liquids from the bag. The number 41 designates a check valve located near the insertion end 31 of the conduit 30. Such check valve may be of a conventional form, but it is arranged in such a manner as to prevent the refluxing of liquid that has already been drained, back into the patient's body. A similar valve 42, with its check valve feature similarly arranged, is located within the conduit 30, near the distal end 32.

FIG. 6 of the drawings shows a modified form in accordance with this invention, wherein the conduit 50 is not provided with any telescoping tube such as those disclosed in FIGS. 1 and 2, but is instead provided with an extendible and retractable protective sheath 51 running substantially the entire length of the conduit 50. In this case, the protective sheath extends beyond the insertion end 52 of the conduit 50, and is sealed upon itself, using a seal such as that identified by the number 53. In the use of the catheter of FIG. 6, the physician or the patient merely grasps the protective sheath 52 near its distal end and slides the conduit 50 through the seal 53, upon inserting it into the patient's body.

Accordingly, it will be appreciated that the catheter in accordance with this invention has solved the problem that stands out above all the rest in patients using urinary catheters --the problem of infection. Such infection is usually the result of contamination of the urinary catheter with pathogenic micro-organisms.

Usually, such contamination occurs either by contamination of the catheter by the individual inserting the catheter, by contamination of the catheter by the patient receiving the catheter (micro-organisms living in the distal part of the urethra), or by contamination of the external wall of a catheter which is indwelling. In the latter case, the most common source of infection is the patient's own perineum followed by the bed clothes, and by the attending staff which manipulates the catheter. Infection may also occur from infected urine which has been extruded into a urinary collection device and remains attached to a catheter.

In accordance with this invention, infection is substantially precluded notwithstanding the potential sources of contamination referred to above.

In the past, closed systems have consisted of indwelling catheters having a tubular extension that is adjoined to the catheter itself. Studies have shown that bacteria can migrate from the bag up the wall of the catheter to reach the bladder. Such migration is effectively prevented in accordance with this invention.

A further point which is relevant to this invention is the fact that bacteria capable of causing disease live in the distal urethra. These bacteria are often pushed into the bladder with the introduction of the catheter. The catheter equipped with the meatal dilator described in this specification markedly reduces this occurrence since the meatal dilator contacts and covers the area involved and insulates it from the catheter tube which is introduced into the bladder.

It has also been demonstrated that, in devices of the prior art, bacteria can migrate up the external wall of the catheter reaching the bladder by way of the urethra. Further, if oftens occurs that a urinary collecting device is displaced by someone on the hospital staff to a level higher than the bladder itself, with reflux occurring into the bladder from the collecting device and the collecting tube. This is the result of lifting the collecting device either by the patient himself, or by the hospital staff, above the level of the bladder.

Although one-way valves have been suggested in the prior art with respect to the collecting device, to prevent reflux from the bag when the bag is lifted above the level of the bladder, it is now been discovered that it is also important to provide for prevention of reverse flow from the catheter tube itself. Accordingly, in accordance with this invention, a check valve has been provided adjacent to the insertion end of the catheter, thus preventing the fluid to drain back from the catheter into the patient's body.

The prior art shows the concept of placing flutter valves on the collecting device to prevent reflux of already infected urine. This ignores the fact that has been developed, that the major source of reflux is from the catheter itself, and the placement of valves in the catheter as well as in the collecting tube joining the catheter to the collecting device is important. It should preferably include a drop-well at the termination of the catheter conduit.

Although this invention has been described in connection with a urinary catheter, it will be appreciated that the catheter may be used for a variety of other purposes. Further, although various anchoring devices may be used for anchoring the catheter to the penis, equivalent devices may be applied such as a vaginal dilator, in the female.

Further, the catheter according to this invention has special advantage in catheterizing a female. The role of catheterizing a female is usually delegated to a female, i.e. nurse, orderly, etc., and quite commonly one may observe the catheter being inadvertently or mistakenly placed in the vagina only to be withdrawn and replaced in the urethra and fed into the bladder with resulting danger of initiating bladder infection. Heretofore, no catheter manufacturer has provided a vaginal occluder which denies access to the vagina by the catheter, thereby insuring initial placement in the urethra.

It will be appreciated that various alternate forms of collecting devices may be used for the fluid, and that antiseptic material may be contained within the collecting bag. Time-release capsules may be used, so that antiseptic or bactericidal or bacteriostatic materials can be released at various points in time.

In using catheters according to this invention, many patients are enabled to employ self-catheterization which, in rehabilitation medicine, is frequently the most desirable.

Self-catheterization is the treatment of choice for the neurogenic bladder secondary to spinal cord or brain malfunction. Many patients, especially quadraplegic patients with a functional cord level at the sixth cervical spinal cord level (C-6, a common spinal cord functional level after trauma) have been denied this treatment of choice by the catheters of the prior art, since they do not account for the inability of the patient to use fine hand movement. Accordingly, it is an object of this invention to provide a catheter offering this type of patient the best opportunity for self-catherization. This often prevents the necessity for major abdominal and genito-urinary surgery, which is always life-threatening and is usually associated with substantial morbidity and increased hospital stay. This morbidity is also operative in preventing optimum physical, mental and social restoration to the patient. The catheter which is the object of this invention is, accordingly, ideally adapted to be used by patients with neurological disorders involving the bladder and also the upper extremities.

Although the telescoping tubes in the forms of the invention shown in FIGS. 1, 2 and 6 are tight fitting, and are capable of substantially completely impeding the migration of bateria along the catheter tube 10, it is sometimes desirable to apply a bactericidal ointment or jelly to the surfaces of these tubes before they are enclosed by the supplemental protective sheet 21, 51. Other variations in the actual use of the catheter will further become apparent to skilled physicians.

It will be appreciated that catheters in accordance with this invention are useful for other uses than urinary catheters. For example, they can be used for tracheal aspiration as in the case, for example, of a patient who has had a tracheotomy where his respirations are embarrased by excess secretions. In such a situation the patient has difficulty coughing up, because of the open tracheotomy tube, and therefore excess fluids need to be suctioned out. Catheters in accordance with this invention are ideally suited for that purpose, and their capability of preventing bacterial infection is an important factor in such use.

Although this invention has been described with reference to specific forms thereof, it will be appreciated that many variations may be made without departing from the spirit and scope of this invention. For example, certain parts may be reversed and, as has been observed in connection with FIGS. 2 and 6, certain parts may be omitted. Further, equivalent elements may be substituted for those specifically shown and described, all within the spirit and scope of this invention and defined in the appended claims.

Claims

The following is claimed:

1. A catheter comprising means forming an elongated flexible conduit an operative portion of the length of which is intended to be inserted into the body, said conduit having an insertion end constructed and arranged for insertion through a passage in the body, and for flow of fluid through said conduit, said conduit having a distal end spaced apart from said insertion end, and means forming an extendible and retractable protective sheath extending at least about said operative length from said insertion end toward said distal end and sealed to inhibit invasion of foreign micro-organisms to the entire corresponding surface of said conduit and maintaining a substantially sterile condition on the entire corresponding surface of said conduit, the outer surface of said conduit being sealed with respect to said sheath against invasion of foreign micro-organisms, and said conduit having an opening for the discharge of said fluid beyond said sheath, said conduit being longitudinally slidable relative to said sheath for insertion into the body, and at least a portion of said sheath being retractable without interfering with the integrity of the protective seal to permit such relative sliding of said conduit, said outer surface of said operative length which is to be inserted into the patient's body being protected from bacterial invasion through said sheath during the period of insertion and the period of use.

2. The catheter defined in claim 1, wherein said catheter is an intermittent use catheter and said distal end is free.

3. The catheter defined in claim 1, wherein said catheter is an indwelling catheter and a fluid collecting chamber is formed integrally on said distal end and sealed thereto.

4. The catheter defined in claim 1, wherein said sheath comprises a pair of tubes slidably arranged on said conduit, one of said tubes also being slidable over the other said tube, whereby said tubes are telescopically contractable to facilitate insertion of said conduit into the body, while maintaining the integrity of the protective sheath.

5. The catheter defined in claim 4, wherein at least one of said tubes are substantially rigid when manually gripped for insertion of said conduit.

6. The catheter defined in claim 4, wherein a light-weight, flexible supplemental sheath is sealed to each of said tubes and encloses completely the zone in which one said tube is telescoped over the other said tube.

7. The catheter defined in claim 1, wherein said sheath has an end of reduced size which extends beyond said insertion end of said conduit and comprises a dilator which is insertable into the body before insertion of said insertable conduit end.

8. The catheter defined in claim 1, wherein said sheath is substantially accordion-pleated.

9. The indwelling catheter defined in claim 3, wherein said sheath is substantially accordion-pleated.

10. The indwelling catheter of claim 3, wherein said sheath comprises a pair of tubes slidably arranged on said conduit, one of said tubes also being slidable over the other said tube.

11. The indwelling catheter defined in claim 3, wherein sealing and anchoring means is secured to said protective sheath outside of said conduit and is also secured to the body into which said conduit is inserted.

12. The indwelling catheter defined in claim 3, wherein a check valve is provided in said conduit, between said insertion end and said collection chamber, preventing flow of body fluid from said chamber back into said body.

13. The indwelling catheter defined in claim 12, wherein a plurality of said check valves are provided in said conduit.

14. The indwelling catheter defined in claim 13, wherein one said valve is adjacent to said container and another said valve is adjacent to said insertion end of said conduit.

15. The catheter defined in claim 1, wherein said sheath extends beyond the insertion end of said conduit and is sealed beyond said end.

16. The catheter defined in claim 2, wherein a collection chamber is mounted on said distal end.

17. A body fluid removable catheter having a means for sterile insertion into a body comprising:

means forming a catheter conduit having a body insertion end portion and a fluid discharge end portion, said body insertion portion having a first protective tube slidably enclosing a length of said insertion portion, a means for extending said catheter insertion portion comprising a second protective tube portion fixed, sealed to and enclosing a length of said fluid discharge end portion, said first and second protective tube portions being telescopically connected and having a combined length greater than the sealed length of said catheter conduit, whereby sliding motion of said first protective tube with respect to said second protective tube extends said catheter.

18. The catheter defined in claim 17 including a contamination prohibiting means comprising a collapsible flexible supplemental sheath, one end thereof being attached adjacent to an end of said first protective tube and the second end thereof being attached adjacent to an end of said second protective tube.

19. The catheter defined in claim 17 wherein said catheter has a dilator portion on said body insertion end portion.

20. The catheter defined in claim 19 wherein said dilator is provided with a seal cap.

21. The catheter defined in claim 20 wherein a lubrication medium is contained within said seal cap.

22. The catheter defined in claim 17 wherein said catheter is an intermittent use catheter and said body insertion end portion is free.

23. The catheter defined in claim 17 wherein said first and second protective tubes are slidably arranged on said body insertion end portion of said catheter conduit and said fluid discharge end portion of said catheter conduit, one of said tubes also being slidable over the other said tube, whereby said tubes are telescopically contractable to facilitate insertion of said body insertion end portion into the body, while maintaining the integrity of the protective sheath formed by said pair of tubes.

24. The catheter defined in claim 17, wherein said first protective tube is substantially rigid when manually gripped for insertion of said body insertion end portion.

25. The catheter defined in claim 17, wherein a lightweight, flexible supplemental sheath is sealed to said first and second protective tubes and encloses completely the zone in which one said tube is telescoped over the other said tube.

26. The catheter defined in claim 17, wherein said body insertion end portion has an end of reduced size which extends beyond said insertion end and comprises a dilator which is insertable into the body before insertion of said body insertion end portion.

27. The catheter defined in claim 17 wherein a lightweight, flexible supplemental sheath is sealed to each of said first and second protective tubes, said sheath being substantially accordion-pleated.

28. The catheter defined in claim 27, wherein said first and second protective tubes are slidable with respect to each other, and are also slidable with respect to the body insertion end portion and the fluid discharge end portion.

29. The catheter defined in claim 17, wherein a supplemental sheath is provided which is sealed to each of said first and second protective tubes and which extends beyond said body insertion end portion and is sealed beyond said end.

30. An improved catheter substantially sealed against the invasion of micro-organism infection of the type comprising a means for forming an elongated flexible conduit a portion of the length of which is intended to be inserted into the body, said conduit having an insertion end constructed and arranged for insertion through a passage in the body, and for flow of fluid into and through said conduit, said conduit having a distal end spaced apart from said insertion end and having an opening for the discharge of said fluid;

the improvement which consists of means forming an extendible and retractable protective sheath extending at least about said length from said insertion end toward said distal end, means for providing against the invasion of micro-organisms comprising a sealed connection between said conduit and said sheath located adjacent said distal end of said conduit, and maintaining a substantially sterile condition on the entire corresponding surface of said conduit, said distal end having said opening beyond said sheath, said conduit being longitudinally slidable relative to said sheath for insertion into the body and said sheath being retractable to permit such relative sliding of said conduit.