AU2004264259B2

AU2004264259B2 - Self-dilation of uretheral stricture

Info

Publication number: AU2004264259B2
Application number: AU2004264259A
Authority: AU
Inventors: Basim Alali
Original assignee: Alali Basim Dr
Current assignee: Alali Basim Dr
Priority date: 2003-08-19
Filing date: 2004-08-12
Publication date: 2006-06-29
Anticipated expiration: 2024-08-12
Also published as: AU2004264259A1

Description

WO 2005/016436 PCTiAU2004/001084

SELF-DILATION

OF

URETHIERAL STRICTURE This invention relates to self-dilatation of urethral stricture.

Many people suffer from urethral stricture. The only methods of treatment available are those performed by urologists. Some of these methods are progressive insertion of rigid probes having different diameters; optical urethrotomy which is a surgical operation and in the severe cases urethroplasty may be indicated. The disadvantages of these methods are: Firstly, every time each of the above treatment is done; an increase in the amount of fibrous tissue is produced and hence increasing the length and the narrowing of the stricture. Secondly, each of which causes an open wound that the patient may suffer pain and/or discomfort immediately after surgery and during urination. Thirdly, possibility of infection and hence necessitate treatment of the infection. Fourthly, it is costly to the patient and for health system. Finally, the patient has to have some time off work.

Because of the chronic nature of this problem, the patient needs regular treatment of the stricture, may be once a year, it could be more frequent or less frequent dependent on the severity of the stricture.

It would be more convenient and cheaper and ultimately better way of management of this problem if the dilation can be carried safely and at regular intervals by the patient himself. If such management made to be foolproof it would make the dilation better, cheaper, safer, and comfortable for the patient.

One self-dilating catheter has been suggested. The catheter is the type used for the drainage of the bladder which is a single tube that must be introduced into the urethra and pushed all the way until reaches the bladder. As soon as the urine starts coming out, the insertion of the catheter is stopped. The catheter is rotated 360 degrees and then removed.

This method has the following disadvantages: Firstly, it interferes with the function of the sphincter. Secondly, it reaches the bladder with the possibility of causing damage and/or infection of bladder. Thirdly, the catheter is soft and can be easily squeezed by the stricture and hence you need to rotate the catheter 360 degrees hoping that it would cause some stricture dilation.

The above disadvantages are overcome by this novel invention of the self-dilation, which provides a self-dilation of urethral stricture device comprising a delimiter which allows a predetermined length of a dilator to be introduced into urethra and hence exactly locating the stricture, and a dilator designed to work together with the delimiter to affect dilation of the stricture, the dilation is carried out by the patient at regular intervals and as directed by the urologist.

In one form of the invention, the delimiter is a 25 cm long rule with holes set at 2.5 mm a part, at one end is a cap that can be snugly placed on top of the crown of the penis and at WO 2005/016436 PCT/AU2004/001084 the other end a sliding fence stopper which when fixed to the rule bya screw would allow only a predetermined length of the dilator to be inserted into urethra, in between the cap and fence stopper is a dilator holder, upon insertion, prevents the dilator from slipping away from urethra.

In a second form of the invention, the dilator is a hollow tube having one end with an inflatable head of one centimeter in length and on the other end a fence with a syringe connector, the fence together with the delimiter allows a predetermined length of the dilator being inserted into urethra.

In a third form of the invention, the dilator is a hollow tube having internal diameter of three millimeters and having no inflatable head but only a fence, together with this tube, several flexible solid probes with different diameters each of which can be inserted into the tube prior insertion into urethra.

In a fourth form of the invention, the cap of the delimiter can be made adjustable by having a slit along the cap and adjustable straps or any other locking device to render the cap capable of fitting different size crown penis.

In a fifth form of the invention, the dilator holder of the delimiter may have straps or any other locking device to hold the dilator in place.

In a sixth.form of the invention, the sliding fence stopper of the delimiter may be controlled by using a rotating knob on a threaded rule.

In a seventh fonrm. of the invention, the inflatable head of the dilator in the second form is supported on four sides by ridges of the same material, the body is made of harder material and having an internal diameter narrower than the inflatable head.

In an eighth form of the invention, the inflatable head of dilator in second form having one layer of softer material while the rest of the body is covered with three layers: the softer layer used for the head, a braiding tape and a layer of harder material.

In a ninth form of the invention, the inflatable head of a dilator of the second form is supported at four sides by metal strips to give it sufficient rigidity, the parts of strips that extended beyond the inflatable head is braided together with the rest of the body and then the entire dilator is covered with a second layer.

In a tenth form of the invention, the dilator is an elastic tube that is fixed at both ends to movable concentric tubes, when the elastic tube is stretched it would become thin and when pressed it would expand, this form would be introduced (instead of the probes) into a dilator of a third form prior to the dilatation.

In an eleventh form of the invention, the dilator a spring strips fixed at both ends and has two concentric tubes when the fixed ends are brought together the strips will bend WO 2005/016436 PCTiAU20041001084 outwards and expand. This form would be introduced (instead of the probes) into a dilator of a third form prior to the dilatation.

The delimiter can be made either of plastic or metal. The cap that sits on the penis crown is made of BioMedical grade material The dilators in the second, third, seventh, eighth, and ninth forms are made of BioMedical grade materials and the elastic tube in the tenth form is made of rubber. The strips for the eleventh form can be metallic or any suitable plastic. The concentric tubes may be made of metal or plastic.

To assist with understanding the invention, reference will now be made to accompanying drawings that show several examples of the invention.

In the drawings: FIG. 1 shows First form (details of Delimiter) according to this invention.

FIG. 1 shows dimensions of Delimiter according to this invention FIG. 2 shows the whole device assembly according to this invention.

FIG. 3 shows the working of one example of dilators according to this invention FIG. 4 shows Second form (typical dilator) according to this invention FIG. 5 shows Third form according to this invention FIG. 6 shows Seventh form according to this invention FIG. 7 shows Eighth form according to this invention FIG. 8 shows ninth form according to this invention.

According to this invention there are two parts to this self- dilation of urethral stricture device, these are: A. The Delimiter that introduces the dilator to the right spot in the urethra to affect dilation.

B. The Dilator that produce the dilation of the stricture.

A. The Delimiter The delimiter controls the distance allowed for the dilator to be introduced into the urethra. Referring to FIG. 1 it can be seen that the delimiter according to this invention is comprised of the cap that in application, would sit snugly on the crown of the penis. The cap has an opening that surrounds the opening of the urethra with sufficient clearance to prevent it from being in contact with the dilator on insertion to the urethra. The cap can be made to be adjustable to fit different size crowns. The cap is sitting and firmly fixed to a 25 cm long rule that has distance-controlling holes The rule is connected on the other end with a sliding plate that is part of fence stopper The sliding plate has two holes used for locking the fence stopper to the rule. The urologist will determine the desired length the dilator needs be inserted and then locks (using a screw) the hole on the plate to a desired hole on the rule, hence locking the WO 2005/016436 PCT/AU2004/001084 delimiter to the required setting. The dilator holder has a groove used for firmly holding the dilator to the delimiter and therefore upon insertion, the dilator will not slip away from the penis. The dilator will sit in a straight line arrangement on the fence stopper, dilator holder and the middle of the cap opening FIG 1(b) shows the dimensions of each part of the Delimiter. The dimensions are in centimeters.

FIG 2 according to this invention, shows the whole device assembly. After the urologist has determined and locked the permissible length that can be inserted, the patient can use the device by himself Firstly, the patient would insert the fence end of the dilator through the cap and place it on the fence stopper leaving the insertable part free to be inserted into the urethra. The part of the dilator between the cap and the fence stopper is placed on the dilator holder and while the patient is holding the dilator firmly against the dilator holder, the dilator is inserted all the way until the cap sits snugly on the crown of the penis.

In case of using the inflatable dilator, the patient would connect the syringe and inject water to inflate dilator's head to a tolerable limit. The inflation of the head may be done as many times as the urologist prescribe.

In case of using the dilator with probes (form three according to this invention), dependent on the size of the stricture either only the dilator or the dilator in which any required probe is inserted prior to the introduction of the dilator to urethra.

Each of these dilation process can be repeated once a week or once every two weeks or as recommended by the urologist.

FIG 3 shows the process of dilatation before and after the injection of water. After locking the delimiter to the right setting, the insertion of the dilator to the urethra would locate the middle of the stricture to the middle of the inflatable head. The patient injects water to inflate the head to a tolerable limit and not exceeding the permissible limit.

Having the delimiter would make dilating the stricture fool proof because the patient can not intiroduce the dilator beyond or before the stricture nor allowing the dilator to reach the sphincter or the bladder. As far as head's inflation is concern, the inflation can be controlled by either making the syringe comes sealed with certain amount of water or told by the urologist the amount of water that can be injected into the dilator.

B. Dilator: According to this invention there are four forms of dilators all sharing the same basic structure.

Referring to FIG. 4 it can be seen that the dilator device according to this invention, is comprised of four parts. The inflatable head (located at one end of the dilator) is made of soft material that can be inflated. The body is an extension to present the inflatable head to the stricture. The body should not be long enough to reach the sphincter or the bladder.

At the other end of the dilator is the Fence, its job is to be used together with the Delimiter to determine the extent by which the dilator can be inserted into the urethra.

Connected to the Fence is a syringe connector the sort that locks into the syringe head.

WO 2005/016436 PCT/AU2004/001084 Referring to FIG. 5 it can be seen that the dilator in the third form of the invention has only two parts: the dilator has a Fence and a Body which is a tube with an internal diameter of three millimeters and an outside diameter of five and a half millimeter. The dilator is inserted into the urethra using the Delimiter, once in location; it can be rotated 360 degrees. If the tube passes through the stricture easily, a probe with appropriate diameter is then chosen and screwed into the dilator prior to inserting the dilator into the urethra. Three different diameter probes are used. Dependent on the diameter of the stricture progressively wider diameter probes can be used to stretch the urethra.

Referring to FIG. 6 it can be seen that the dilator in the seventh form according to this invention has the same four parts as in FIG 4. However, the inflatable head as shown in its cross section composed of a tube with internal diameter of 2 mm and a 1.25 mm thick layer. In addition, the inflatable head has four ridges to give it rigidity toward the stricture. The body is made of a tube of harder material than that for the inflatable head and an internal diameter of 1 mm and external diameter of 5.5 mm. The head is glued to the rest of the dilator.

Referring to FIG. 7 it can be seen that the dilator in the eighth forn of the invention has the same four parts as in FIG. 4. However it is composed of the following layers. Inner layer made of softer material and having thickness of 1 mm surrounding a hollow core of two millimeter in diameter. Large part of the dilator is braided with a thin tape; the unbraided part is one centimeter in length and acts as an inflatable head. The braiding would give the body sufficient strength to render the head inflatable in preference to the body. The braided part of the dilator is covered with a third layer made of harder material and having a thickness of 0.74 millimeter.

Referring to FIG. 8 it can be seen that the dilator in the ninth form of this invention has a one millimeter thick layer of a soft material surrounding a core of 1.5 millimeters. Two metal strips are used to give rigidity to the head, the strips cross over the tip of the head and extend beyond it to cover half a centimeter of the body. The metal strips that extended to the body together with the rest of the body are covered with braiding tape.

The whole of the dilator is covered with a second layer to bring the total outside diameter of the dilator to five and a half(5.5) millimeters.

It will be realized that the dilator device according to this invention is not restricted to the form of inflated head shown in the example, but may use spring or rubber dilators. The dilator may be used for dilatation of other strictures.

Claims

3. The self-dilation of urethral stricture device of claim 1 and 2 wherein the fence stopper is irreversibly locked in position.
4. The self-dilation of urethral stricture device of claim 1 and 2 wherein the fence stopper is fixed in position and can only be changed by a deliberate intervention. The self-dilation of urethral stricture device of claim 1 and 2 wherein the delimiter is a 25 cm long rule with holes set at 2.5 mm a part, at one end is a cap that can be snugly placed on top of the crown of the penis and at the other end a sliding fence stopper which when fixed to the rule by a screw would allow only a predetermined length of the dilator to be inserted into urethra, in between the cap and fence stopper is a dilator holder, upon insertion, prevents the dilator from slipping away from urethra
6. The self-dilation of urethral stricture device of claim I and 2 wherein the dilator is a hollow tube having one end with an inflatable head of one centimeter in length and on the other end a fence with a syringe connector, the fence together with the delimiter allows a predetermined length of the dilator being inserted into urethra.
7. The self-dilation of urethral stricture device of claim 1 and 2 wherein, the dilator is a hollow tube having internal diameter of three millimeters and having no inflatable head but only a fence, together with this tube, several flexible solid probes with different diameters each of which can be inserted into the tube prior insertion into urethra.
8. The self-dilation of urethral stricture device of any one of claims 1 and 2 wherein the cap of the delimiter can be made adjustable by having a slit along the cap and adjustable straps or any other locking device, to render the cap capable of fitting different size, crown penis.
9. The self-dilation of urethral stricture device of any one of claims 1 and 2 wherein the dilator holder of the delimiter may have straps or any other locking device to hold the dilator in place. self-dilation of urethral stricture device of any one of claims I and 2 wherein the sliding fence stopper of the delimiter may be controlled by using a rotating knob on a threaded rule. O O 11 .The self-dilation of urethral stricture device of any one of claims 1,2 and 6 wherein the inflatable head of the dilator in the second form is supported on four sides by ridges of the same material, the body is made of harder material and having an internal diameter narrower than the inflatable head. Cl
12.The self-dilation of urethral stricture device of any one of claims 1,2 and 6 wherein the inflatable head of dilator in second form having one layer of softer material while the rest of the body is covered with three layers: the softer layer used for the head, a braiding tape and a layer of harder material. Cl 7 13.The self-dilation of urethral stricture device of any one of claims 1, 2 and 6 wherein the ID N, inflatable head of a dilator of the second form is supported at four sides by metal strips to give it 7sufficient rigidity, the parts of strips that extended beyond the inflatable head is braided together o with the rest of the body and then the entire dilator is covered with a second layer. C'l
14.The self-dilation of urethral stricture device of any one of claims 1 and 2 wherein the dilator is an elastic tube that is fixed at both ends to movable concentric tubes, when the elastic tube is stretched it would become thin and when pressed it would expand, this form would be introduced into a dilator of a third form prior to the dilatation. self-dilation of urethral stricture device of any one of claims 1 and 2 wherein the dilator is a spring strips fixed at both ends and has two concentric tubes when the fixed ends are brought together the strips will bend outwards and expand, this form would be introduced into a dilator of a third form prior to the dilatation.
16.A self-dilation of urethral stricture device substantially as herein described with reference to the drawings in FIG. 1 (a and b) and FIG.