JPH0225628B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION Field of the Invention The present invention relates to improvements in medical devices, and more particularly to urinary catheter assemblies.

[Problems to be solved by conventional technology and invention]

One of the most common medical procedures is the insertion of medical instruments into the body canal. For example, the insertion of a cotton swab or catheter into the urethra. However, despite advances in infection prevention in many areas of medical technology, these medical procedures still result in infections of organs such as the bladder.

Only if the area around the body tract is thoroughly cleaned, the catheter is sterilized, the operator is wearing surgical gloves and a mask, and no infection has already occurred.
Catheterization is the standard method. The cause of infection has been found to be due to bacteria present within the body canal, particularly in the outer part of the body canal, and which are difficult, if not impossible, to eliminate prior to insertion of the instrument.
Thus, when the instrument enters the body canal, it comes into contact with bacteria and carries them along the body canal, causing an infection at the distal end inside the body canal. Preliminary cleaning of the area, including the outer portion of the body canal, often does not prevent infection.

Several proposals have been made to prevent devices from carrying bacteria along the body canal, but none have proven to be completely successful. for example,
U.S. Patent No. 3332424, U.S. Patent No. 3908635, U.S. Patent No.
No. 3,908,663 discloses a catheter consisting of a thin flexible tube of material and a rigid collar attached to one end thereof. In use, a collar is placed around the entrance to the body canal and the tube is pushed through the collar, allowing the tube to gradually turn over along the body canal. Therefore, the movement of the tube wall relative to the body canal wall is reduced so that bacteria are less transported along the body canal, but bacteria are still delivered to the anterior open end of the tube as the tube everts. These bacteria reaccumulate further into the body canal with successive turns of the tube. Thus, while these previously proposed catheters are an improvement over the basic catheter, these catheters have caused contamination by carrying bacteria further into the body tract.

U.S. Pat. No. 3,669,099 discloses a device similar to the prior art described above, which has an everted tube for contacting the wall of a body cavity, but
In this case, the end of the tube is fixed and sealed to a rigid cylindrical tube surrounding it, so that the tube forms a closed conical chamber filled with liquid. A long cylindrical medical instrument can be pushed through the tube, and the pressure of the liquid flips the tube outward as the instrument passes through the tube. This device, which has already been proposed, is complicated because the liquid inlet must be placed in a rigid tube in order to inject the liquid at the appropriate pressure, and the presence of the conical chamber makes the device wide and therefore difficult for the patient to use. It becomes somewhat unpleasant. Moreover, the manufacturing price becomes relatively high.

It is an object of the present invention to provide a urinary catheter assembly that is inexpensive to manufacture and that does not cause undue trauma to the patient during use.

[Means to solve the problem]

The urinary catheter assembly according to the present invention comprises:
A urinary catheter assembly used to insert a catheter into the bladder through a urethra whose outer portion is contaminated with bacteria, the catheter assembly comprising a catheter and a hollow cavity having a sidewall impermeable to bacteria. a sheath, the catheter can slide within the sheath, and the sheath has a proximal open end;
a distal closed end that is normally closed and can be opened to allow the catheter to pass therethrough; and a distal closed end that is normally closed and can be opened to allow the catheter to pass through the catheter; a stop means disposed on the outside of the sheath to prevent the distal closed end of the sheath from being closed by a distance substantially equal to the bacterially contaminated outer portion of the urethra; It is characterized in that it can be provided at a distance from the section.

[Effect]

In use, the sheath is inserted into the urethra and the stop means engages the area around the entrance to the urethra, preventing further insertion of the sheath. At this time, the tip of the sheath has substantially passed through the bacterially contaminated outer portion of the urethra, and since the distal closed end of the sheath is closed, the interior of the sheath is not contaminated with bacteria. Not yet. The distal closed end of the sheath is then pushed open and the catheter is inserted through the bacterially free inner portion of the urethra and into the bladder. You can then urinate through this catheter.

〔Example〕

Embodiments of the present invention will be described below with reference to the drawings.

FIG. 1 is a schematic diagram showing the bacterial distribution of the female urethra. The bladder 1 communicates with the outside through the urethra 2. Although the bladder 1 and the inner part of the urethra 2 are sterile, the urethra 2 and the outer part and the area surrounding the entrance to this urethra 2 are heavily contaminated with bacteria 3.
When urinating from the bladder 1 by catheterization, the external area around the urethra 2 is sufficiently cleaned, but it is very difficult to clean the inside of the urethra 2;
A significant amount of bacteria therefore remains in the outer part of the urethra 2. For this reason, insertion of an unprotected catheter, swab, or other medical device into the urethra 2 carries bacteria inward along the urethra 2, and if the device is inserted deep enough, the inner portion of the urethra 2 and Contaminates bladder 1.

2 to 5, the problem of bacteria 3 being carried along the urethra 2 is eliminated or alleviated by providing a tubular catheter 4 of common plastic material within the sheath 5. sheath 5
is a plastic outer tube 6 coaxial with the catheter 4.
and a cover 7 made of latex rubber. Preferably, one end of the cover 7 is tapered to facilitate insertion into the urethra and to provide effective sealing. One end of the cover 7 is formed by a closed wall in the shape of a cannonball, and a cross-shaped slit is formed in the closed wall. Therefore, the cover 7
to provide a sheath against the passage of bacteria when in the closed position as in FIGS. 3 and 4, while applying force to the outer tube 6 and catheter 4 as shown in FIGS. Allow these to pass through. The cover 7 forms the distal closed end of the sheath 5, and when it is made openable by a slit as in the embodiment, the cover 7
is elastic so that the slit recloses when the catheter 4 is drawn into the sheath 5. Therefore, when removing the catheter 4 from the urethra,
Bacteria are prevented from entering the sheath 5. In other configurations, the sheath 5 can have a membrane over its ends. This membrane ruptures when the catheter 4 is pressed against it.

Furthermore, a collar 8 is provided on the outside of the cover 7, which in use abuts the area around the entrance to the urethra 2 and prevents further insertion of the cover 7.
The cover 7 is first inserted into the urethra 2, but at this stage the slitted closed end of the cover 7 is inserted into the urethra 2.
It is located in the area indicated by "X" in the figure. Since the collar 8 is spaced apart from both ends of the sheath 5, the sheath 5 can be easily grasped by the user with the collar 8 stopped and the cover 7 fully inserted into the urethra. That is, the outer tube 6 can be grasped. The outer tube 6 is then pushed toward the slitted end of the cover 7 to open the slit. The outer tube 6 is further inserted into the urethra 2 without penetrating into the bladder 1. Since the ends of the cover 7 are closed during the initial insertion, the bacterial contamination of the outer tube 6 as it passes through the cover 7 is negligible.

In the final stage of insertion, the catheter 4 is pushed through the outer tube 6 and into the bladder 1. The bladder 1 can therefore urinate without risk of infection.

In the embodiment, the sheath 5 is equipped with an outer tube 6 that can slide within the cover 7, but the sheath 5 can also be configured, for example, by the cover 7 without the outer tube 6. In this case, the catheter 4 can be inserted directly into the cover 7, the closed end of the cover 7 can be pushed open by the catheter 4, and the catheter 4 can then be inserted through the urethra 2 into the bladder 1. In any event, it is desirable that the sheath be sufficiently long to allow for gripping the sheath outside of the body canal during use to facilitate use of the device. In this case, the risk of contamination of the bladder 1 is somewhat high, but in reality it is negligible.

The inner diameter of the outer tube 6 is the same as or slightly smaller than the outer diameter of the catheter 4, so that the catheter 4 is retained within the outer tube 6 and does not become dislodged during use. Alternatively, the diameter of the opening in the rubber collar 8 can be such that it tightens the outer tube 6 and catheter 4 to achieve the same purpose.

In this embodiment of the invention, it is important that the length of the outer tube 6 must be sufficiently greater than the maximum distance that the catheter 4 projects from the cover 7 in use. In this case, any contamination of the catheter 4 outside the outer tube 6 will not be transmitted along the outer tube 6 to the urethra 2 or the bladder 1. Furthermore, when the catheter 4 is used as described above, the outer tube 6 must not be pushed through the cover 7 to an extent greater than the length of the cover 7. This further prevents bacteria from being carried into the bladder 1 or urethra 2.

Thus, by making the sheath 5 longer than the portion of the catheter 4 that is inserted into the urethra 2 and placing that portion of the catheter 4 within the sheath 5 prior to use, the user is able to wear surgical gloves and Can be modified for use without the need to wear other protective clothing. In this way, only the portion of the catheter 4 that does not enter the urethra 2 is grasped, so that bacteria will not be transmitted from the user's hand to the urethra 2 through the catheter.

In FIG. 6, the sheath 5 has two coaxially arranged first outer tubes (first sheath) 10 and second outer tubes (second sheath) 11. Second outer tube 1
1 has a smaller diameter than the first outer tube 10 and extends telescopically into the first outer tube 10 at the joint 12 . The first outer tube 10 has a rubber cover 7 at its distal end. This rubber cover 7 is held on the first outer tube 10 by a rubber collar 8, which functions as a stop member, shown in FIGS. 2 to 5. The cover 7 has a cross-shaped slit formed in its distal end wall. The free end of the second outer tube 11 is attached to the catheter 4 by means of a sleeve 13 which can be connected with a tight fit.

The first outer tube 10 and the second outer tube 11 are made of hard plastic material, the catheter 4 is made of flexible plastic material, and the cover 7 is made of soft rubber.

The device in FIG. 6 is the same as in FIGS. 2 to 5, except that the catheter 4 cannot be directly touched by hand and is protected by a first outer tube 10 and a second outer tube 11. used as such. The catheter 4 is pushed into the urethra 2 by grasping the second outer tube 11 and pushing it into the first outer tube 10.

The rigidity of the first outer tube 10 and the second outer tube 11 allows easy introduction of the flexible catheter 4. A thin plastic cover 14 is attached to the first outer tube 1.
0 and the second outer tube 11 to prevent bacteria from entering between these outer tubes 10 and 11, that is, to prevent contamination of the catheter 4.

〔Effect of the invention〕

As explained above, according to the present invention, the catheter can slide within the sheath, and the sheath can
a proximal open end, a distal closed end that is normally closed and can be opened for passage of the catheter, and a stop means provided on the outside of the sheath, the stop means being configured to prevent bacteria in the urethra. The sheath is spaced from the closed distal end of the sheath by a distance substantially equal to the outer portion contaminated by the bacteria, thereby simplifying the overall construction and preventing the bladder from becoming contaminated with bacteria. The clean, relatively stiff sheath is only partially inserted into the urethra, allowing urination to occur without causing discomfort to the patient.

[Brief explanation of drawings]

1 is a schematic diagram showing the bacterial distribution within the female urethra; FIG. 2 is a sectional side view of a catheter assembly according to the present invention; FIG. 3 is a sectional side view of the catheter assembly of FIG. 2 in use; Figure 4 is an end view corresponding to Figure 2, Figure 5 is an end view corresponding to Figure 3, and Figure 6 is an end view corresponding to Figure 3.
The figure is a side sectional view of yet another modification of the catheter assembly according to the invention. 1... Bladder, 2... Urethra, 3... Bacteria, 4...
Catheter, 5... Sheath, 6, 10, 11...
Outer tube, 7...cover, 8...color.

Claims (1)

[Scope of Claims] 1. A urinary catheter assembly used for inserting a catheter into the bladder through a urethra whose outer portion is contaminated with bacteria, the catheter and a hollow sheath having an impermeable sidewall, within which the catheter can slide, the sheath having a proximally open end that is normally closed and open for passage of the catheter; a distal closed end that can be inserted into the urethra and a stop means provided on the outside of the sheath for engaging the area around the entrance to the urethra to prevent further insertion of the sheath; and wherein the stop means is spaced from the distal closed end of the sheath by a distance substantially equal to the bacterially contaminated outer portion of the urethra. assembled body. 2. The sheath consists of an outer tube that has an open end and allows the catheter to slide inside it, and a cover that covers one end of the outer tube, and the cover is always closed and allows the catheter to pass through it. 2. The urinary catheter assembly of claim 1, wherein the urinary catheter assembly is openable for use. 3. A urinary catheter assembly according to claim 2, wherein said stop means is provided on said cover and said outer tube is slidable within said cover. 4. the distal closed end of the sheath is elastic;
3. A slit is formed in the sheath, and the slit is closed in a normal state, but opens when pressure is applied from inside the sheath to form a hole.
The urinary catheter assembly according to any one of the above. 5. A urinary catheter assembly according to any preceding claim, wherein the stop means is an increased diameter portion of the sheath. 6. The urinary catheter assembly of claim 5, wherein said stop means is formed as a collar extending radially outwardly from said sheath. 7. A urinary catheter assembly according to any preceding claim, wherein the sheath is relatively stiff and the catheter is flexible. 8 consisting of a first sheath on the distal side of the sheath and a second sheath on the proximal side coupled to the first sheath;
The second sheath is movable with the catheter and maintains a longitudinal barrier between the first and second sheaths while maintaining a barrier to bacterial ingress between the first and second sheaths. 8. A urinary catheter assembly according to claim 1, wherein the urinary catheter assembly is capable of relative movement.