GB2510867A

GB2510867A - A device and method to aid catheter insertion into a male patient

Info

Publication number: GB2510867A
Application number: GB201302695A
Authority: GB
Inventors: Thomas James Oakley
Original assignee: Individual
Current assignee: Individual
Priority date: 2013-02-15
Filing date: 2013-02-15
Publication date: 2014-08-20
Anticipated expiration: 2033-02-15
Also published as: GB2510867B; GB201302695D0

Abstract

A device and method to aid catheter insertion into a male patient is disclosed. The device comprises a sheath 2 adapted to fit over the penis of the patient. The sheath 2 has a first opening 3 at one end of the sheath 2, and a second opening 6 at the opposite end of the sheath 2. The first opening 3 is adapted to allow the sheath 2 to be fitted over the penis of the patient, and the second opening 6 is adapted to allow a catheter 7 to be inserted into the urethra of the patient. The sheath further comprises a band 10a, 10b between the first and second openings 3, 6, wherein the band 10a, 10b is adapted to enable retraction of the foreskin of the patient.

Description

A device and method to aid catheter insertion into a male patient This invention relates to devices to aid catheter insertion into male patients. In particular this invention relates to devices that help to create a sterile environment for catheter insertion. In addition, the invention also relates to an improved method for inserting catheters into male patients.

Conventionai catheter insertion kits for male patients comprise a plastic tray, cotton wool balls, tweezers, a sachet of povidone-iodine, two sets of sterile gloves, and a sterile i0 drape. Before catheter insertion, the medical professional performing the procedure, such as a doctor or nurse, must put on a first pair of sterile gloves, empty the sachet of povidone- iodine into the plastic tray, use the tweezers to dip the cotton wool balls into the povidone-iodine, and then use these cotton wool balls to clean the patient's penis. The medical professional must then place the sterile drape over the patient, remove the first pair of gloves, iS and put on the second pair of sterile gloves before handling the catheter and then inserting this catheter into the patient.

After use, each kit must be disposed of The large number of different pieces of equipment making up a catheter insertion kit makes the current procedure for catheter insertion quite a wasteful process. It is therefore an object of the present invention to provide a less wasteful kit for catheter insertion.

Also, it is quite difficult for a patient to self-catheterise, for example when they are at home, using the current catheter insertion kit. It is therefore another object of the present invention to provide a means for catheter insertion that makes it easier for male patients to self-catheterise.

in addition, there is a high risk of infection associated with the catheter insertion process due to the possibility of cross-contamination and inadequate sterilisation. It is a further object of the present invention to lower the risk of infection by reducing the risk of cross-contamination and improving the sterilisation of the environment before catheter insertion.

According to the present invention there is provided a device to aid catheter insertion into a male patient, the device comprising: -a sheath adapted to fit over the penis of the patient, -a first opening at one end of the sheath, and -a second opening at the opposite end of the sheath, wherein the first opening is adapted to allow the sheath to be fitted over the penis of the patient, and the second opening is adapted to allow a catheter to be inserted into the urethra of the patient. and wherein the sheath comprises a band between the first and second openings, wherein lO the band is adapted to enable retraction of the foreskin of the patient.

The sheath may comprise one band. Preferably. the sheath comprises two bands.

wherein the bands are adapted to enable retraction of the foreskin of a patient (if foreskin is present on the patient), and wherein the band closest to the second opening has a smaller iS circumference than the band furthest from the second opening.

It is preferable to have two bands as the two bands make it easier to use the device with small and large penises. When placing the device onto the penis of a male patient, the band furthest from the second opening will retract the foreskin of a larger penis. However, when placing the device onto a patient with a smaller penis, the band furthest from the second opening will be moved over the penis, and the foreskin will instead be retracted by the band closest to the second opening. The sheath may also comprise more than two bands.

The band or bands are preferably annular, and are preferably in the form of a continuous ring. However, one or more of the bands may be arc shaped, or one or more of the bands may comprise spaced segments ananged in a ring or arc configuration.

Preferably. the band or bands are thickened portions of a materi& forming the sheath.

The bands enable retraction of the foreskin by pushing this down as the sheath is fitted.

Preferably, the sheath comprises an elastic material, and the elastic material is preferably latex. The band or bands are, therefore, preferably thickened portions of latex.

The band or bands preferably have a uniform cross section. The cross section of the bands may take many different shapes, for example, the cross section may be rectangular, circular or oval in shape.

Preferably. the sheath is generally cone shaped (i.e. preferably the sheath generally tapers from the first opening to the second opening). The device is preferably provided to a user (for example, a patient or a doctor) in a rolled configuration. Having a cone shaped sheath is advantageous as it makes it easier to unrofi the device onto the patient's penis.

The sheath may also be provided with a bulge (i.e. an area of greater circumference than the rest of the sheath or the parts of the sheath that are directly adjacent to the bulge) between the second opening and the band in the sheath that is nearest to the second opening.

Bulges may also be provided between the successive bands in the sheath. These bulges are shaped to fit around the glans penis and so may enable the device to fit better to the patient's penis. The sheath may also be provided with bulges to accommodate the retracted foreskin.

Some of the bulges provided in the sheath may be shaped to both fit around the glans penis and to accommodate the retracted forekin.

Preferably, the sheath is provided with sterilising media on its outer surface and! or its inner surface. The sterilising media may comprise, for example. iodine, povidone-iodine, or chorohexadene.

Preferably, the second opening is covered by a closed tip on the end of the sheath, wherein the tip is removable to allow a catheter to be inserted into the urethra of the patient.

Preferably, the connection between the tip and the end of the sheath is frangible.

Preferably. the frangible connection between the tip and the end of the sheath is perforated.

Preferably, the removable tip is at least partially filled with materia' soaked in sterilising media. Preferably. the material is a gauze wad. The sterilising media may compnse, for example, iodine, povidone-iodine, or chorohexadene.

The tip may also be narrowed towards or at the connection with the end of the sheath.

This narrowing is advantageous as it helps retain the matenal soaked in the sterilising media in the tip. However, the material soaked in the sterilising media may be retained in the tip by other means, for example, by an adhesive.

The second opening may be surrounded by a band. The band may be provided in place of a closed tip on the end of the sheath, or the device may compnse both a band around the circumference of the second opening and a tip on the end of the sheath.

A band adapted to help retain the sheath on the penis is preferably provided at the first opening.

The bands surrounding the first and second openings are preferably annular, and are preferably in the form of a continuous ring. However, one or both of the bands may be arc shaped, or one or both of the bands may comprise spaced segments arranged in a ring or arc configuration. Preferably, the bands surrounding the first and second openings are thickened portions of a material forming the sheath. The band or bands preferably have a uniform cross section, for example, they may have a circular cross-section.

According to the present invention there is also provided a kit for inserting a catheter into a male patient, the kit comprising: -the device to aid catheter insertion into a male patient described above, and -a catheter adapted to fit inside the urethra of the patient.

According to the present invention there is further provided a method of inserting a catheter into the urethra of a male patient, the method comprising: -fitting the device for aiding catheter insertion into the patient over the penis of the patient in a first step, wherein the first step comprises using the band to retract the foreskin of the patient, and -inserting a catheter through the second opening of the device and into the urethra of the patient in a second step.

Preferably, the device further compnses a closed tip covering the second opening, and the tip is preferably detached from the end of the sheath between the first and second steps.

The tip is preferably attached to the end of the sheath by a frangible connection, and the tip is preferably detached from the end of the sheath by breaking the frangible connection.

Preferably. the device is provided in a rolled configuration. The first step then compnses placing the device over the penis and rolling the sheath down the shaft of the penis.

After the second step, the device is preferably removed from the patient's penis.

lO Preferably, the device is slid off the patient's penis, cut along the length of the sheath, and detached from the patient and the catheter.

Embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which: iS Figure 1 shows an embodiment of a device to aid catheter insertion into a male patient in an unrolled configuration and with a tip attached; Figure 2 shows the embodiment of Figure 1 with the tip removed and a catheter inserted through the second opening; Figure 3 shows an alternative embodiment of a device to aid catheter insertion with a catheter inserted through the second opening; Figure 4 shows the embodiment of Figure 1 in a rolled configuration; and Figure 5 shows an exploded view of Figure 4. where a gauze wad is shown outside the tip.

Referring to Figures ito 5, two embodiments of a device ito aid catheter insertion into a male patient are shown. The figures show a device 1 compilsing a sheath 2, with a first opening 3 in one end of the sheath 2, a second opening 6 in the opposite end of the sheath, a band S around the first opening, and two bands I Oa, I Ob between the first and second openings.

In the embodiment of Figures 1,2,4 and 5, the device 1 is provided with a tip 4 covering the second opening 6.

Figure 1 shows the device with the tip 4 attached to the sheath 2. Before a catheter 7 can be inserted through the second opening 6 in the sheath 2 of this embodiment, the tip 4 must first be disconnected from the sheath 2. The connection 5 between the tip 4 and the sheath 2 is perforated. The perforated connection allows the tip 4 to be easily torn off the sheath 2.

In other embodiments, the frangible connection between the tip 4 and the sheath 2 could comprise a thinner region in the material from which the tip 4 and sheath 2 are manufactured, for example. Providing a device 1 with a thin region of material would also lO enable the tip to be easily disconnected from the sheath, for example by tearing or cutting.

In the embodiment shown in Figure 1, the tip 4 over the second opening 6 of the device 1 helps to provide a sterile environment inside the device 1. This is because when the device i is fitted over the penis of the patient, the inside of the device 1 is closed to the external atmosphere reducing the chance of contaminants getting inside the device.

In the embodiment shown in Figure 3, instead of having a device I with a closed tip on the end of the sheath, the second opening 6 is surrounded by a band in the form of an annular thickened portion 9. The band 9 helps to keep the second opening 6 open, and so makes it easy to insert the catheter through the second opening 6.

lii another embodiment of the invention, the device I could be provided with both a band 9 and a tip 4.

In some embodiments, the band 9 could help to provide a closed sterile environment inside the device if the edges of the band contact each other, for example by being biased towards each other, to close off the second opening 6. Then, before inserting a catheter 7 through the opening 6. sides of the band 9 could be squeezed together or pulled apart to open the opening 6 and allow the catheter 7 to be inserted into the patient's urethra.

Referring to Figures ito 5, the sheath 2 is preferably made from an elastic material, preferably latex. However, the sheath can alternatively be made of other elastic materials such as polyurethane. Making the sheath 2 from elastic materials can be advantageous as it allows the device ito be securely fastened on the patient's penis.

The device 1 of Figures Ito 5 is preferably coated with an antiseptic media on both the inner and outer surfaces of the sheath 2. The embodiment of Figures 1, 2, 4 and 5 also preferably has a coating of antiseptic media on the inner and outer surfaces of the tip 4. The antiseptic media is preferably povidone-iodine but it coirid alternatively be chlorohexadene, an alternative iodine solution, or any other antiseptic medium.

In some embodiments of the invention, antiseptic media is provided on the inner surface of the device. This helps to provide a sterile environment for catheter insertion as lO when the device is fitted over the penis of the patient, the antiseptic media sterilises the skin of the patient's penis. However, alternatively, the skin of the patient's penis could be sterilised before the device is fitted to the patient. for example by using cotton wool balls dipped in antiseptic media.

iS In some embodiments of the invention, antiseptic media is provided on the outer surface of the device, This also helps to provide a sterile environment for catheter insertion, by sterilising the outer surface of the device. Then, if a user, such as a medical professional of patient, was to touch the outer surface of the device during the catheter insertion process, this would not contaminate the catheter insertion process as the antiseptic media would help to keep the outer surface of the device sterile and, additionally, would sterilise the hands of the user.

However, alternatively, the outer surface of the device could be sterilised after the device has been fitted over the patient's penis, for example using cotton wool balls dipped in antiseptic media. As a further alternative, it may not be necessary to sterilise the outer surface of the device if the device is manufactured in a sterile environment which ensures that the outer surface of the device is free from contaminants.

Figures 1, 2 and 3, show embodiments of the device 1 provided with an annular band 8 around the circumference of the first opening 3. The first band 8 is adapted to help hold the device i on penis of the patient. Preferably, the band 8 is formed from a thickened portion of the sheath, and preferaHy the band 8 is elastic.

Referring to Figures 1, 2 and 3, the embodiments of the device 1 shown are additionally provided with elastic bands iOa, lOb, located at positions along the length of the sheath 2 between the first 3 and second 6 openings. Preferably, the bands i0a, lOb are formed from thickened portions of the sheath, and preferably the bands lOa, lOb are annular.

The dastic bands I Oa, I Ob are adapted to retract the foreskin of the patient when the device is fitted over the patient's penis. This is achieved by sliding the device 1 over the glans penis so that one of the elastic bands lOa, lOb holds the retracted foreskin in place.

When placing the device onto the penis of a male patient, the elastic band lOb furthest lO from the second opening will retract the patient's the foreskin. However, if the patient has a smaller penis, the elastic band lOb furthest from the second opening will pass over the penis, and the foreskin will instead be retracted by the elastic band I Oa closest to the second opening. Embodiments of the device may also comprise only a single elastic band, or more than two elastic bands portioned between the first 3 and second 6 openings. iS

lii the embodiments shown in Figures 1, 2 and 3, the band 8 around the first opening 3 and the elastic bands lOa, lOb are all continuous annular rings. However, in other embodiments of the device 1, one or more of these thickened portions may comprise one or more sections alTanged intermittently in an annular configuration.

in some embodiments of the invention, the device 1 may be provided to the user, for example the medical professional or patient, in a rolled configuration. The embodiment of the device of Figure i is shown in rolled configurations in Figures 4 and 5. To fit the device I shown in Figures 4 and 5 over the penis, the sheath 2 must be unrolled over the length of the patient's penis to provide a sterile environment along the length of the patient's penis.

Figure 4 shows the device I in a rolled configuration. in use, the unrolled device is first placed onto the end of the patient's penis. One of the elastic bands I Oa, I Ob is then fitted over the glans penis of the patient to hold the foreskin in place. The rest of the device 1 is then rolled shown the shaft of the penis.

In alternative embodiments of the invention, the device I may be provided to the user in a partially unrolled configuration, wherein the sheath 2 is rolled from the band 8 surrounding the first opening to the elastic band lOb nearest to the first opening only.

Figure 5 shows an exploded view of the rolled device 1 of Figure 4 with a gauze wad 11 shown outside inside the tip 4. The gauze wad Ii is soaked in antiseptic medium and is designed to clean the penile meatus (i.e. the urethral meatus), For example. the gauze wad maybe used to clean the penile meatus by contacting the end of the patient's penis when the device 1 is placed onto the penis. Alternatively (or additionally), the penile rneatus could be cleaned by wiping it with the open end of the tip 4 after the tip 4 has been separated from the sheath 2.

lO As can be seen from Figure 4, in the illustrated embodiment, the gauze wad ii is retained within the tip 4 by a narrowed portion 12 at the base of the tip 4.

Referring to all the Figures, the catheter 7 may be provided separately to the device 1.

Alternatively, the device I and catheter 7 may compnse a kit for catheter insertion. is

In some embodiments of the invention, an anaesthetic gel is injected into the urethra through the patient's penile meatus to numb the penis before the catheter is inserted. Suitable anaesthetic gels include InstillageFT. Preferably, the anaesthetic gel is inserted into the urethra after the device I has been placed over the penis. In embodiments in which a tip 4 is present, the anaesthetic gel is preferaNy inserted into the patient's urethra in the step after the tip 4 has been removed.

In some embodiments of the invention, the device I is left in place on the patient's penis. for example for a couple of days, after the catheter has been inserted into the patient's urethra. In alternative embodiments, the device is removed from the patient shortly after the catheter has been inserted. In such embodiments, the device may be slid off the penis after use, and then cut in half, for example using a pair of scissors to detach the device from the patient and the catheter. However, in some embodiments, the device may be provided with a perforated strip along the length of the device 1, wherein the peitorated strip can be torn to separate the device I and remove it from the patient's penis.

Claims

Claims 1. A device to aid catheter insertion into a male patient, the device comprising: -a sheath adapted to fit over the penis of the patient, -a first opening at one end of the sheath, and -a second opening at the opposite end of the sheath, wherein the first opening is adapted to allow the sheath to be fitted over the penis of the patient, and the second opening is adapted to allow a catheter to be inserted into the urethra of the patient, and wherein the sheath comprises a band bctween the first and second openings, wherein the band is adapted to enable retraction of the foreskin of the patient.
2. A device as claimed in Claim 1, wherein the sheath comprises two bands, wherein the bands are adapted to enable retraction of the foreskin of a patient, and wherein the band closest to the second opening has a smaller circumference than the band furthest from the second opening.
3. A device as claimed in Claim 1, wherein the band or bands are annular.
4. A device as claimed in Claim I or 2, wherein the band or bands are thickened portions of a material forming the sheath.
5. A device as claimed in any preceding claim, wherein the sheath comprises an elastic material.
6. A device as claimed in Claim 5 wherein the sheath comprises latex.
7. A device as claimed in any one of any preceding claim, wherein the sheath is provided with sterilising media on its outer surface.
8. A device as claimed in any preceding claim, wherein the sheath is provided with sterilising media on its inner surface.
9. A device as claimed in any preceding claim, wherein the second opening is covered by a closed tip on the end of the sheath, wherein the tip is removable to allow a cathetertobeinsertedintotheurethraofthepatient.
10. A device as claimed in Claim 9, wherein the connection between the tip and the end of the sheath is frangible.
11. A device as claimed in Claim 10, wherein the connection between the tip and the end of the sheath is perforated.
12. A dcvicc as claimed in any one of Claims 10 to 12, whcrcin thc removable tip is at least partially filled with a material soaked in sterilising media.
13. A device as claimed in Claim 7,8 or 13, wherein the sterilising media comprises iodine, povidone-iodine, or chorohexadene.
14. A device as claimed in any preceding claim, wherein the second opening is surrounded by a band.
15. A device as claimed in any preceding claim, wherein a band adapted to help retain the sheath on the penis is provided at the first opening.
16. A kit for inserting a catheter into a male patient, the kit comprising: -thc dcvice of Claim 1, and -a catheter adapted to fit inside the urethra of the patient 17. A method of inserting a catheter into the urethra of a male patient, the method comprising: -fittingthe deviceofClaim 1 overthepenisofthepatientinaflrststep,wherein the first step comprises using the band to refract the foreskin of the patient, and -inserting a catheter through the second opening of the device of Claim I and into the urethra of the patient in a second step.18. A method as claimed in Claim 17, wherein the device further comprises a closed tip covering the second opening, and wherein the tip is detached from the end of the sheath between the first and second steps.19. A method as claimed in Claim 18, wherein the tip is attached to the end of the sheath by a frangible connection, and wherein the tip is detached fixm the end of the sheath by breaking the frangible connection.20. A method as claimed in any one of Claims 17 to 19, wherein the device is provided in a rolled configuration, and the first step comprises placing the device over the penis, and then rolling the sheath down the shaft of the penis.21. A method as claimed in any one of Claims 17 to 20, wherein after the second step the dcvicc is removed from thc paticnt's penis.22. A method as claimed in Claim 21, wherein after the second step the device is slid off the patient's penis, cut along the length of the sheath, and detached from the patient and the catheter.23. A device to aid catheter insertion into a male patient substantially as hereinbeibre described with reference to, and as illustrated by, the accompanying drawings.24. A kit for inserting a catheter into a male patient substantially as hereinbefore described with reference to, and as illustrated by, the accompanying drawings.25. A method of inserting a catheter into the urethra of a male patient substantially as hcrcinbcforc described with reference to the accompanying drawings.Amended claims have been filed as foHows:-Claims 1. A device to aid catheter insertion into a male patient, the device comprising: -a sheath adapted to fit over the penis of the patient, -a first opening at one end of the sheath, and -a second opening at the opposite end of the sheath, wherein the first opening is adapted to allow the sheath to be fitted over the penis of the patient. and the second opening is adapted to aflow a catheter to be inserted into the urethra of the patient, and wherein the sheath comprises a band between the first and second openings, wherein the band is adapted to enable retraction of the foreskin of the patient.2. A device as claimed in Claim 1, wherein the sheath comprises two bands, wherein the bands are adapted to enable retraction of the foreskin of a patient, and wherein the band closest to the second opening has a smaller circumference than the band furthest C1) from the second opening.I0 3. A device as claimed in Claim I. wherein the band or bands are annular. a,4. A device as claimed in Claim I or 2, wherein the band or bands are thickened portions of a material forming the sheath.5. A device as claimed in any preceding claim, wherein the sheath comprises an elastic material.6. A device as claimed in Claim 5 wherein the sheath comprises latex.7. A device as claimed in any one of any preceding claim, wherein the sheath is provided with sterilising media on its outer suitace.8. A device as claimed in any preceding claim, wherein the sheath is provided with sterilising media on its inner surface.9. A device as claimed in any preceding claim, wherein the second opening is covered by a closed tip on the end of the sheath, wherein the tip is removable to allow a catheter to be inserted in to the urethra of the patient.10. A device as claimed in Claim 9. wherein the connection between the tip and the end of the sheath is frangible.I. A devicc as claimed in Claim 10, whercin the connection between the tip and the end of the sheath is perforated.12. A device as claimed in any one of Claims 10 to 12, wherein the removable tip is at least partially tilled with a material soaked in sterilising media.13. A device as claimed in Claim 7, 8 or 13, wherein the sterilising media comprises iodine. povidone-iodine. or chorohexadene.14. A device as claimed in any preceding claim, wherein the second opening is surrounded by a band.15. A device as claimed in any preceding claim, wherein a band adapted to help retain the sheath on the penis is provided at the first opening.16. A kit for inserting a catheter into a male patient, the kit comprising: -the device of Claim 1, and -a catheter adapted to fit inside the urethra of the patient.
17. A device to aid catheter insertion into a male patient substantially as hereinbefore described with reference to, and as illustrated by, the accompanying drawings.
18. A kit for inserting a catheter into a male patient substantially as hereinbefore described with reference to, and as illustrated by, the accompanying drawings.