WO2006126061A1 - An ancillary device for the preparation of a natural orifice to an endoluminal procedure - Google Patents

Abstract

The invention relates to an ancillary device for preparing a proximal part (2a) of a natural lumen (2) opening onto a natural orifice (1) to an endoluminal procedure, wherein said device comprises a plug member (10) for engaging the internal surface of said orifice and proximal part of said lumen, said plug member comprising a protruding dispensing member (5) having an external surface of increasing cross section from a distal end (7) to a proximal end (11 ), a central passage (12) for expelling a treatment fluid, and connecting means (4) with a source (14) of said treatment fluid. The invention also relates to a an ancillary device for occluding a natural orifice, wherein said device comprises a plug member for engaging the internal surface of said orifice, said plug member comprising a protruding member having an external surface of increasing cross-section from a distal end to a proximal end.

Description

An ancillary device for the preparation of a natural orifice to an endoluminal procedure

Goal

An ancillary device as contemplated by the present invention is intended to be used for the preparation of any natural orifice (and/or a proximal part of a natural lumen) of the human body before any endoluminal procedure.

The device allows in one step:

- Dilation of the orifice,

- Temporary occlusion of the orifice and

- Instillation through the orifice.

The device may be applied to several orifices of the human body. The device can be used for the preparation of the anus for example before endoscopic exploration or instrumental procedure like ultrasonically guided transrectal prostate biopsy. It can be used for the preparation of the male urethra meatus before insertion of an indwelling Foley catheter or any device for diagnostic or therapeutic purpose.

The following description will focus, as an example, on the preparation of the urethra meatus in males before insertion of an indwelling Foley catheter or any instrument for diagnostic or therapeutic purpose in an endoluminal procedure.

Alternatively, the device of the invention may be used as a therapeutic means for retromeatic urethra stenosis especially iatrogenic stenosis secondary to Foley catheterization or transurethral resection of the prostate.

Present state of the art As shown by figure 1 , the male urethra has the shape of a tube with several portions with different diameters (Fig 1). The smallest diameter is located at the meatus 1 of the penile portion. The fossa navicularis 2 inside the glans penis 3 has a large diameter. The proximal part 2a of this natural lumen has a smaller diameter.

Preparation of the male urethra to the insertion of any device or instrumentation (instrument) used for diagnostic or therapeutic purpose comprises three steps:

- instillation of the urethra with an anaesthetic and/or a lubricant gel (gel),

- clamping of the penis, for instance with a penile clamp, to prevent backwards leakage through the urethra meatus,

- and if necessary dilation of the urethra meatus to facilitate the insertion of the instrument.

This preparation requires the use of three categories of material:

- a seringe or seringe like vial containing a dose of gel, or any other treatment fluid.

- a penile clamp to prevent leakage and maintain the urethra filled with the gel,

- a set of dilators or bougies with increasing diameters to calibrate and /or dilate if necessary the urethra meatus to the size appropriate to the one of the instrument to be inserted.

Among the devices of the state of the art, none of them is appropriate to perform the steps described above in a satisfying manner : usually, the shape, size and/or design of these devices, like for example seringe or seringe-like vials, catheter spigots or conical connectors, are not adapted for an atraumatic dilation of urethra meatus. The problems raised by this situation are as follows:

- storage inflation of disposable materials (gel vial, penile clamp, disposable bougies with various sizes),

- gel leakage leading to :

- insufficient lubrication or anesthesia of the urethra,

- consumption increase : a second gel vial is necessary to lubricate the bougies and the instrument (endoscope),

- time consumption of the cleaning and the sterilization of the penile clamp.

The solution proposed is a device allowing the accomplishment of the three steps using only a single device.

The present invention concerns an ancillary device allowing in one step:

- Dilation of the natural orifice and/or natural lumen,

- Temporary occlusion of the natural orifice and/or natural lumen and

- Instillation through the natural orifice and/or natural lumen.

The invention is now introduced and further defined with reference to the annexed drawing wherein:

- Figure 1 represents in a schematical manner the anatomy of the penile portion of the urethra,

- Figure 2 schematically represents an ancillary device, more precisely a plug member with a reservoir or a source of treatment fluid, according to the present invention,

- Figure 3 represents the way the plug member is inserted and secured into the penis up to the desired growth,

- Figure 4 represents in a schematical manner a plug member according to the invention having a connection means of the Luer type,

- Figure 5 represents in a schematical manner a plug member according to the invention having an occluding means, - Figure 6 represents in a schematical manner a plug member according to the invention, which is not perforated.

Legends for figures

For Figure 1 , as a matter of reference there are shown:

1- urethral meatus

2- fossa navicularis

3- penis glans

For figures 2 to 6:

4 connecting means

5 protruding dispensing member

7 distal end of protruding dispensing member

10 plug member

11 proximal end of protruding dispensing member

12 central passage

13 grooves

14 source or reservoir

Generally as shown by Figure 2 in annex, an ancillary device according to the present invention comprises a plug member 10 for engaging the internal surface of said orifice and proximal part of said lumen, said plug member comprising a protruding dispensing member 5 having an external surface of increasing cross section from a distal end 7 to a proximal end 11, a central passage 12 for expelling a treatment fluid, and connecting means 4 with a source 14 of said treatment fluid.

The source of treatment fluid may be a reservoir of said treatment fluid.

Within the meaning of the present invention, the treatment fluid may be a lubricant or an anaesthetic gel.

The external surface 10a of said plug member 10 has a trunked-conical shape, as an example. In particular, the external surface 10a of said plug member comprises peripheral grooves 13 defining a sinusoidal shape on the external surface of said plug. In particular, the grooves give a smooth and wavy shape to the external surface of the plug member.

Preferably, the ancillary device according to the present invention comprises or incorporates a source or reservoir 14 of said treatment fluid, for instance a gel. In an embodiment of the invention, the source of treatment fluid is a dispersible source.

Description of the device

More precisely, as exemplified with reference to Figure 2, the ancillary device comprises:

- a reservoir or source 14 containing the gel to be instilled, and a passage 12, and an evacuation conduit allowing in one step: the dilation of the meatus to the size of the instrument to be inserted through the meatus,

- the temporary autostatic occlusion of the meatus preventing from leakage of the gel, and

- the instillation of the gel,

The shape of the reservoir can be the cylinder of a seringe with a plunger or any deformable reservoir that can be squeezed to evacuate its content. In the latter, the shape of the source can be geometrical like a sphere or non-geometrical like a squeezable pouch. In the case of a deformable reservoir, the structure of the wall is preferentially such that the reservoir should not recover spontaneously the shape it had when filled earlier. This feature prevents from re-aspiration of the treatment fluid once instilled inside the urethra.

The plug member 10 allowing the emptying of the source consists in a hollow trunked cone. Preferably, the tip of the cone has a diameter adapted to the natural diameter of the meatus of the male urethra to allow an easy insertion of the tip of the device, for example 16 french Charriere ( 5 mm diameter).

Preferably, the tip of the cone has a smooth shape like the male part of a Luer connection.

Preferably, the base of the cone has a diameter adapted to the size of the instruments to be inserted in the urethra. The largest diameter allows dilation slightly above the size of the instrument with the largest diameter used for diagnostic or therapeutic purpose, i.e. dilation up to 30 french Charriere ( 9.5 mm diameter ).

Preferably, the base of the cone is followed by a plate with a much larger diameter. The plate prevents from:

- dilating more,

- catching the cone inside the urethra if there was a drop in diameter beyond the base of the cone.

Preferably, the slope of the cone is smooth enough to allow a progressive atraumatic dilation of the natural orifice/lumen. The angle of the cone is preferably inferior to 25 degrees, and more preferably is about 10 degrees.

Preferably, the surface of the cone is interrupted by grooves reducing the diameter at equidistant intervals.

Preferably, the grooves have an increasing diameter starting from 16 up to 30 french Charriere with increments of 2 french Charriere.

- The shape of the grooves is preferentially semi-elliptic or semi-circle rather than sharp angles observed in the design of conical connections of the prior art, used for the safe connection of inert materials such as flexible tubes. The sinusoidal shape of the surface of the cone of the device of the invention facilitates insertion but also extraction of the cone with minimal strength.

Preferably, the depth of the grooves provides the best compromise to allow easy dilation, autostatic positioning and easy retrieval of the device.

Preferably, the tip of the cone and the grooves have smooth edges.

Preferably, the tip of the cone is perforated.

The tip of the cone may have a male Luer shape allowing its closure with a luer cap.

Preferably, the base of the cone is in continuation with a plate and the wall of the source or reservoir 14.

An ancillary device as previously described is used as now described with reference to Figure 3.

A few millilitres of the gel contained in the source or reservoir are deposited on the meatus and inside the fossa naviculars of the urethra.

The tip of the cone is inserted through the meatus until a light resistance is felt. At this point the size of the natural diameter of the meatus can be measured before any dilation. The diameter is calculated from the number of grooves 13 remaining outside of it.

For instance, in the case where the grooves have an increasing diameter starting from 16 up to 30 french Charriere with increments of 2 french Charriere, if three grooves remain outside, the diameter will be 30-(2X3)=24 french Charriere. This measurement tells if the insertion of the cone needs to be continued or not.

For example, when the diameter of the instrument to be inserted is :

- smaller or equal to the diameter of the meatus, then the tip of the cone is slightly pushed forward to the next groove 13 to secure the device at the tip of the penis; the instillation is completed without any leakage and the dilation operates under local anesthesia. Urethra meatus dilation is minimal; - larger than the diameter of the meatus, then the cone is progressively pushed forward until the groove 13 with the diameter just above the one of the instrument to be inserted is reached. The device is secured in place by itself to the penis, the instillation is completed without any leakage and the dilation operates under local anesthesia.

As soon as the time necessary for local anaesthesia and dilation has elapsed, the cone is extracted from the meatus and the instrument for diagnostic or therapeutic purpose is inserted.

The plug member 10 may have no continuity with the source or reservoir 14.

As shown on figure 4, the cone may have on the side of its base a connection means 4 of the Luer type for example, which allows the connection with a reservoir or a seringe or any device for medical use with the opposite Luer tip.

In another embodiment of the invention as shown on figure 5, the cone may include an occluding means 8 like a valve or stopcock. In such an embodiment, the cone is preferably made of silicone. The cone then may play the role of a sphincter in patients with urinary incontinence. This external sphincter is opened by the patient for bladder emptying and closed afterwards. When necessary, the device can be removed and replaced by a new one.

The following embodiments are now considered:

- the source 14 can be filled with any injectable treatment fluid, preferentially under gel or liquid form.

- the treatment fluid injected can have per se a diagnostic or therapeutic property.

- the cone may be used solely without connection to a source or reservoir. The design is then a hollow or solid cone. The tip and the base are no more opened. As such it can be used as a plug to prevent urinary or anal incontinence (refer to Figure 6 ).

According to Figure 6, an ancillary device for occluding a natural orifice is shown, wherein said device comprises a plug member 10 for engaging the internal surface of said orifice, said plug member comprising a protruding member 5 having an external surface of increasing cross-section from a distal end 7 to a proximal end 11.

Claims

1. An ancillary device for preparing a proximal part (2a) of a natural lumen (2) opening onto a natural orifice (1 ) to an endoluminal procedure, wherein said device comprises a plug member (10) for engaging the internal surface of said orifice and proximal part of said lumen, said plug member comprising a protruding dispensing member (5) having an external surface of increasing cross section from a distal end (7) to a proximal end (11), a central passage (12) for expelling a treatment fluid, and connecting means (4) with a source (14) of said treatment fluid.

2. A device according to claim 1, wherein the external surface (10a) of said plug member (10) has a trunked-conical shape.

3. A device according to claim 1, wherein the external surface (10a) of said plug member comprises peripheral grooves(13) defining a sinusoidal shape on the external surface of said plug.

4. A device according to claim 1 , further comprising a source of treatment fluid, for instance a gel.

5. An ancillary device for occluding a natural orifice, wherein said device comprises a plug member (10) for engaging the internal surface of said orifice, said plug member comprising a protruding member (5) having an external surface of increasing cross-section from a distal end (7) to a proximal end (11 ).