Field of the invention

The present invention relates to an indwelling catheter intended to be used in connection with prostate treatments or prostate surgery, such as e.g. an invasive prostate therapy.

Technical Background

Indwelling catheters intended in connection with prostate surgery are known. One example is described in US2006111691 , which reveals a partiallength catheter intended to open a urine drainage passageway of the prostatic urethra or to open the external urinary sphincter muscle for discharging urine from the bladder.

The present invention provides an improved catheter of the type presented in US2006111691 . The catheter according to the present invention is improved with reference to increasing the possible usage areas as well as limiting certain occurring potential problems with this type of catheters. Summary of the invention

The stated purpose above is achieved by an indwelling catheter comprising two connectable and separable main units being

- an introduction stent unit with a top and bottom portion, said introduction stent unit also comprising a bladder fluid opening, wherein said introduction stent unit has a length possible to arrange with the top inside of the bladder of a patient and with the bottom portion arranged inside of the urethra before the external urinary sphincter muscle of the patient when seen from the bladder and outwards;

- a catheter filling unit with an open bottom end and a top portion, said catheter filling unit being detachable form the indwelling catheter; said indwelling catheter also comprising

- a balloon stopper unit in connection with and thus possible to fill via a balloon filling tube and out from a balloon fluid inlet opening arranged on the introduction stent unit, wherein the filling of the balloon stopper unit with a sterile fluid, preferably sterile water, is intended when the balloon stopper unit is arranged inside of the bladder of the patient to provide for a stopper function of the balloon stopper unit against the bladder neck of the patient; and

- a pull thread fixedly arranged on the introduction stent unit to enable pulling of the introduction stent unit when the catheter filling unit is detached from the indwelling catheter, wherein the indwelling catheter also comprises a coupling unit being arranged to connect the top portion of the catheter filling unit and the bottom portion of the introduction stent unit, and wherein the coupling unit is releasably arranged on an outside of the catheter filling unit and releasably arranged on an inside of the introduction stent unit to tightly connect the catheter filling unit to the introduction stent unit, also ensuring that the introduction stent unit and the catheter filling unit may be released from one another.

The expression “releasably arranged” implies that the coupling unit is not permanently fixated, but may be connected and disconnected. The coupling unit may be kept in place only by providing a suitable diameter size of the coupling unit in connection with the diameter size of the bottom portion 2b of the introduction stent unit 2 and the diameter size of the top portion 3b of the catheter filling unit 3, and with a certain flexibility of the material, and/or a suitable level of friction forces, also by choice of material. This may be understood when viewing the figures providing one such example. Also other possibilities are possible, such as connection via other type of locking and unlocking mechanisms between the parts mentioned above.

As mentioned above, the indwelling catheter according to the present invention comprises a coupling unit being arranged to connect the top portion of the catheter filling unit and the bottom portion of the introduction stent unit where the coupling unit is arranged on an outside of the catheter filling unit and arranged on an inside of the introduction stent unit.

The arrangement of the coupling unit provides for several advantages. First of all, this type of coupling unit enables to provide for suitable inner diameter along the entire catheter avoiding clogging and clotting issues inside of the catheter. As gel is used for different usages, such clogging and clotting problems are often occurring in this type of catheters. Secondly, based on the type of arrangement provided according to the present invention, the device may be used as a regular catheter for flushing operations etc., e.g. during bleeding, as long as desired before activating the stent functionality as further described below with reference to the figures.

Other features and advantages of the present invention will be further described below.

Brief description of the drawings

In figs. 1 and 2 there are shown one embodiment of the present invention.

In figs. 3-6 there are shown possible usage of an indwelling catheter according to the present invention.

Specific embodiments of the invention

Some specific embodiments of the present invention are further disclosed and described below.

The indwelling catheter according to the present invention has several advantages when compared to known such catheters. First of all, a geometrical narrowing in the catheter is avoided, which is important as gel clogging or clotting inside of the catheter are avoided. Fact is that the catheter according to the present invention may provide a laminar flow inside of the catheter, which may drive the avoidance of such clogging or clotting of gel.

As should eb understood from above, the indwelling catheter according to the present invention has multiple functionalities, both functioning as a regular catheter but also as a stent when the catheter filling unit is released from the introduction stent unit. The catheter according to the present invention has an optimal coupling between the catheter filling unit and introduction stent unit, enabling a laminar flow inside of the catheter as explained above, but also providing a simple releasing of the two units when the catheter should function as a stent instead. This also ensures that the catheter is suitable to function as a catheter for a longer time before going over to being a stent. Gelling and flushing inside of the catheter is simple to conduct, which is important. Moreover, the indwelling catheter according to the present invention may be kept as a catheter after a prostate treatment or surgery. Moreover, the catheter may be slushed when bleeding occurs or for patients where anticoagulants are used. The stent may be activated after up to 3 - 7 days. This is beneficial for the healthcare system. Also the risk of clogging and clotting are prevented. Furthermore, with the increased level of passage through the indwelling catheter, this may be used together with a catheter guide for catheter introduction.

The indwelling catheter according to the present invention may be provided in different shapes, types and embodiments, as further explained below.

According to one embodiment of the present invention, the bottom portion of the introduction stent unit and part along the introduction stent unit is beveled on an inside of the introduction stent unit to fit the coupling unit tightly in the introduction stent unit. This may provide a better fixating and adjustment of the catheter filling unit and introduction stent unit into one another via the coupling unit.

Moreover, according to yet another embodiment of the present invention, the top portion of the catheter filling unit and part along the catheter filling unit is beveled on an outside of the catheter filling unit to fit the coupling unit tightly on the catheter filling unit. As should be understood also this embodiment may provide an improved adjustment of the different units to fit one another. Furthermore, and in line with the above, according to yet another embodiment of the present invention, the bottom portion of the introduction stent unit and part along the introduction stent unit is beveled on an inside of the introduction stent unit to fit the coupling unit tightly in the introduction stent unit and wherein the top portion of the catheter filling unit and part along the catheter filling unit is beveled on an outside of the catheter filling unit to fit the coupling unit tightly on the catheter filling unit.

Moreover, and in line with what has been mentioned above, according to one embodiment of the present invention, the coupling unit is arranged to counteract a geometrical narrowing inside at least the catheter filling unit, preferably along both the catheter filling unit and the introduction stent unit. Furthermore, according to yet another specific embodiment of the present invention, the geometrical inner diameter is substantially the same along the catheter filling unit and the introduction stent unit when connected via the coupling unit. As may be understood from below, this may also be provided according to one embodiment of the present invention without the coupling unit.

Moreover, according to yet another embodiment of the present invention, the geometrical inner diameter along the catheter filling unit and the introduction stent unit is in the range of 4 - 10 mm, preferably in a range of 6 - 10 mm.

According to yet another embodiment of the present invention, the balloon filling tube has a portion with a spiral shape along the balloon filling tube at a position outside and a distance from the bottom portion of the introduction stent unit, to enable anchoring inside of the urethra and outside of the external urinary sphincter muscle of the patient when seen from the bladder and outwards.

Furthermore, according to yet another embodiment of the present invention, the introduction stent unit from the top to the bottom portion has a total length in the range of 30 - 70 mm.

According to a second aspect of the present invention there is provided an indwelling catheter comprising two connectable and separable main units being

- an introduction stent unit with a top and bottom portion, said introduction stent unit also comprising a bladder fluid opening, wherein said introduction stent unit has a length possible to arrange with the top inside of the bladder of a patient and with the bottom portion arranged inside of the urethra before the external urinary sphincter muscle of the patient when seen from the bladder and outwards;

- a catheter filling unit with an open bottom end and a top portion, said catheter filling unit being detachable form the indwelling catheter; said indwelling catheter also comprising

- a balloon stopper unit in connection with and thus possible to fill via a balloon filling tube and out from a balloon fluid inlet opening arranged on the introduction stent unit, wherein the filling of the balloon stopper unit with a sterile fluid, preferably sterile water, is intended when the balloon stopper unit is arranged inside of the bladder of the patient to provide for a stopper function of the balloon stopper unit against the bladder neck of the patient; and

- a pull thread fixedly arranged on the introduction stent unit to enable pulling of the introduction stent unit when the catheter filling unit is detached from the indwelling catheter , wherein the catheter filling unit is coupled directly into the introduction stent unit to tightly connect the catheter filling unit into the introduction stent unit, also ensuring that the introduction stent unit and the catheter filling unit may be released from one another, and to provide substantially the same diameter along both the catheter filling unit and the introduction stent unit.

In line with what has been mentioned above, according to yet another embodiment of this second aspect, the top portion of the catheter filling unit and part along the catheter filling unit is beveled on an outside of the catheter filling unit to fit tightly into the bottom portion of the introduction stent unit and part along the introduction stent unit which in turn is beveled on an inside of the introduction stent unit.

According to yet another embodiment there is provided a diagnostic kit comprising an indwelling catheter according to the present invention, wherein the diagnostic kit also comprises

- a set volume of saline solution, or a corresponding solution, contained in a syringe connectable to the open bottom end of the catheter filling unit; and

- a drainage and diagnosis container with volume markings.

In relation to the above it should be noted that the diagnostic kit according to the present invention also comprises a set volume of a saline solution (or corresponding solution) contained in a syringe connectable to the open bottom end of the catheter filling unit; and a drainage and diagnosis container with volume markings, which both are not shown above. For these two units, different shapes and sizes etc. may be used according to the present invention. Furthermore, and with reference to the figures (see fig. 1 ), according to one specific embodiment, the diagnostic kit also comprises a balloon filling syringe connectable to the balloon filling tube, preferably connectable to a receptacle situated on the end of the balloon filling tube, more preferably connectable to a receptacle situated on the end of the balloon filling tube before a valve arrangement, preferably wherein said balloon filling syringe comprises sterile fluid, suitably sterile water, intended to fill the balloon stopper unit.

Detailed description of the drawings

In fig. 1 , and 2a and 2b, there is provided one embodiment of the present invention. According to this alternative the indwelling catheter 1 comprises an introduction stent unit 2 with a top 2a and bottom portion 2b, and a bladder fluid opening 20, and a catheter filling unit 3 with an open bottom end 3a and a top portion 3b. Moreover, the indwelling catheter 1 also comprises a balloon stopper unit 4 in connection with a balloon filling tube 5, and a balloon fluid inlet opening 21 arranged on the introduction stent unit 2. The balloon filling tube 5 has a portion 50 with a spiral shape along the balloon filling tube 5 at a position outside and a distance from the bottom portion 2b of the introduction stent unit 2, to enable anchoring inside of the urethra and outside of the external urinary sphincter muscle of the patient when seen from the bladder and outwards. In this case there is also provided a receptacle 51 situated on the end of the balloon filling tube 5 before a valve arrangement 52. Moreover, a pull thread 6 is fixedly arranged on the introduction stent unit 2 to enable pulling of the introduction stent unit 2 when the catheter filling unit 3 is detached from the indwelling catheter 1.

Moreover, and as more clearly seen in fig. 2a and 2b, the indwelling catheter 1 also comprises a coupling unit 99 being arranged to connect the top portion 3b of the catheter filling unit 3 and the bottom portion 2b of the introduction stent unit 2, where the coupling unit 99 is releasably arranged on an outside of the catheter filling unit 3 and releasably arranged on an inside of the introduction stent unit 2 to tightly connect the catheter filling unit 3 to the introduction stent unit 2, also ensuring that the introduction stent unit 2 and the catheter filling unit 3 may be released from one another. The difference between figs. 2a and 2b relate to the shape of the coupling unit 99. According to the embodiment shown in fig. 2a, the coupling unit 99 is arranged to fit in a suitable way to ensure a substantially same diameter inside of the entire indwelling catheter 1 . If there is any diameter change there may a minor extension in the last part of the introduction stent unit 2.

In fig. 2b yet another embodiment of the coupling unit 99 is shown. In this case this has the shape of a stair step. Moreover, in this case the portions 2b and 3b suitable are beveled to fit for such as coupling unit 99.

The present invention is also directed to a diagnostic method. According to one specific embodiment, the diagnosis is directed to evaluating if a patient is a suitable candidate for prostate surgery or treatment based on the calculation of urinated volume I volume of saline solution (or corresponding solution) flown into the bladder.

Furthermore, according to yet another embodiment, the diagnosis is directed to evaluating if a patient is a suitable candidate for prostate surgery or treatment based on the urinated volume during a set time range, preferably a time range of 30 seconds or less, more preferably a time range of 15 seconds.

Moreover, according to yet another embodiment of the present invention, the diagnosis also includes at least one of the following:

- evaluation with reference to if the patient is able to urinate on request;

- evaluation with reference to if the patient is able to avoid leakage during movement.

In relation to the diagnostic method according to the present invention, the following criteria are such showing a strong result indicating that the patient is suitable for a prostate surgery/treatment:

- the patient is able to urinate on request (this also implies the ability of stopping the urination on a request and starting the same again thereafter);

- the patient is able to avoid leakage during movement;

- the patient is able to urinate at least 1 dl during a time frame of less than 15 seconds; and - the patient is able to urinate at least 50% of the saline solution flown into the bladder.

The diagnostic method according to the present invention also provides insight on the patient’s coordination ability of the bladder and the outer sphincter muscle, i.e. the patient’s ability to avoid urination when the bladder is full and using the outer sphincter muscle to ensure this.

Moreover, the present invention is also directed to use of a diagnostic kit according to the present invention, for performing a diagnosis directed to evaluating if a patient is a suitable candidate for prostate surgery/treatment or not based on the calculation of urinated volume I volume of saline solution (or corresponding solution) flown into the bladder after performing filling a volume of saline solution (or corresponding solution) into the bladder of the patient and measuring the volume of urine from patient-driven urination after detachment of the catheter filling unit from the indwelling catheter.

Furthermore, the present invention also refers to use of a diagnostic kit according to the present invention, for performing a method according to the present invention, both as described above and in the claims.

Below there is presented more background and figures in relation to the diagnostic kit with an indwelling catheter according to the present invention. Furthermore, there is also presented more information in relation to the diagnostic method according to the present invention.

Firstly, stent during insertion is presented in fig. 3. Insertion may be performed in accordance with the following:

• Apply anesthetic gel

• Insert

• Fill balloon, tie knots on balloon tube, cut off the valve

• Empty the bladder

• Fill the bladder to prepare for voiding tests

• Separate rear part

Secondly, self-controlled voiding is presented in figs. 4-5.

• Open and close sphincter - physician (see fig. 5)

• Open and close sphincter - patient (see fig. 5) Moreover, self-catheterization is presented in fig. 6.

Some functionality of the present invention

• Before separation the device functions as an ordinary “Foley” Catheter. Pull thread locks front and rear section together.

• Relieves obstruction in the prostatic urethra.

• Balloon and anchoring device holds stent in place,

• Migrated stent, that may cause retention, can be repositioned by the patient himself.

• Micturation can be patient-controlled using the “pull thread”.

As may be understood from above, the diagnostic kit according to the present invention has multi-functionality. The diagnostic kit provides for the following capabilities:

- catheter function;

- stent function;

- diagnostic kit test (urodynamic test) as described above;

- self-catheterization;

With reference to the diagnostic test capability provided according to the present invention, this may provide for:

- Simulates removal of obstruction;

- Provides an answer to if the patient benefit from an invasive therapy, with answers to questions such as: Is he incontinent? I Does he have normal bladder function?