WO2012065940A1

WO2012065940A1 - Medical device for using an endoscopic instrument for diagnostic or operating purposes, particularly in urology and gynecology

Info

Publication number: WO2012065940A1
Application number: PCT/EP2011/070029
Authority: WO
Inventors: Carlo Alberto Bosi
Original assignee: X-Med S.R.L.
Priority date: 2010-11-17
Filing date: 2011-11-14
Publication date: 2012-05-24
Also published as: ITMO20100025U1; EP2640253A1

Abstract

A medical device (1) for using an endoscopic instrument for diagnostic or operating purposes, particularly in urology and gynecology, comprising a rigid guiding cannula (2) for the introduction of the probe of an endoscopic instrument and means (3) of barrier protection of the endoscopic instrument at least at the probe, which are temporarily associable with the cannula (2) and can at least partially be accommodated inside it.

Description

MEDICAL DEVICE FOR USING AN ENDOSCOPIC INSTRUMENT FOR DIAGNOSTIC OR OPERATING PURPOSES, PARTICULARLY IN UROLOGY AND GYNECOLOGY

Technical field

The present invention relates to a medical device for using an endoscopic instrument for diagnostic or operating purposes, particularly in urology and gynecology.

Background Art

In medicine it is known to conduct examinations or procedures using endoscopic techniques, which involve the introduction of optical instruments, known as endoscopes, into the patient's organs or inner cavities, which instruments are essentially constituted by a stem-shaped probe containing a bundle of optic fibers, which have a distal end with respect to the operator that is adapted to be inserted in the body of the patient and is provided with an optical lens, and a proximal end associated with a viewing apparatus, of the type of an eyepiece, a video camera, a still camera or the like.

In some medical applications, a guiding cannula is employed for the insertion of the probe of the endoscope into the body of the patient. In this case, kits are supplied which are constituted by a cannula and by a mandrel that can be removably inserted along the cannula so as to occlude its inner cavity in the initial step of introduction into the body of the patient and it is, subsequently, extracted to allow the introduction of the probe of the endoscope through the cannula until the lens is positioned at the corresponding distal end with respect to the operator.

At the proximal end the cannula is normally provided with a tubular connector provided with one or more ports intercepted by valve elements for the administration of fluids during the performance of the examination and/or of an operating access route for the introduction of a biopsy probe or other medical devices through the interspace defined between the inner wall of the cannula and the probe of the endoscope.

In urology and gynecology, in particular, rigid cannulas made of metallic or plastic material are used.

Following each execution it is necessary to provide for an adequate sterilization both of the cannula and of the probe of the endoscope, which have come into contact with the body fluids of the patient and, possibly, with the medical fluids used during the treatment.

These conventional apparatuses are not devoid of drawbacks among which there is the fact that the periods of dead time associated with the sterilization of the related components, and in particular of the endoscope, following each treatment involve the need for the health facility to reduce the number of services that can be performed in a unit of time, or to procure a higher number of optical instruments.

Moreover, the repeated sterilization of endoscopes can compromise their functionality until they eventually break.

Disclosure of the Invention

The aim of the present invention is to eliminate the above-mentioned drawbacks in the background art, by providing a medical device for using an endoscopic instrument for diagnostic or operating purposes, particularly in urology and gynecology, that makes it possible to avoid the need to sterilize the endoscope following each treatment, thus increasing the number of daily services that can be delivered, reducing the waiting lists for the patients and lowering the operating costs for the health facilities.

Within this aim, an object of the present invention is to reduce the wear and tear of endoscopes, both in the phase of use and in the phase of sterilization, thus keeping their level of efficiency and functionality constant over time.

Another object of the present invention is to provide a simple structure, that is relatively easy and practical to implement, safe to use and effective in operation, and relatively low-cost. This aim and these objects are all achieved by the present medical device for using an endoscopic instrument for diagnostic or operating purposes, particularly in urology and gynecology, comprising a rigid guiding cannula for the introduction of the probe of an endoscopic instrument, characterized in that it comprises means of barrier protection of said endoscopic instrument at least at said probe, which are temporarily associable with said cannula and can at least partially be accommodated inside it.

Brief description of the drawings

Further characteristics and advantages of the present invention will become better apparent from the detailed description of a preferred, but not exclusive, embodiment of a medical device for using an endoscopic instrument for diagnostic or operating purposes, particularly in urology and gynecology, which is illustrated by way of non-limiting example in the accompanying drawings wherein:

Figure 1 is a schematic view, partially interrupted and sectional, of a medical device for using an endoscopic instrument for diagnostic or operating purposes, particularly in urology and gynecology, according to the invention in a first operational configuration;

Figure 2 is a schematic view, partially interrupted and sectional, of the device according to the invention in a second operational configuration;

Figure 3 is a schematic perspective view of the proximal portion of the device according to the invention in the step of insertion of the protection means into the cannula;

Figure 4 is a schematic sectional front elevation view of the proximal portion of the device according to the invention in the step of insertion of the protection means into the cannula;

Figure 5 is a schematic sectional front elevation view of the proximal portion of the device according to the invention when the step of insertion of the protection means into the cannula is complete; Figure 6 is a schematic sectional plan view from below of the proximal portion of the device according to the invention when the step of insertion of the protection means into the cannula is completed.

Ways of carrying out the Invention

With reference to the figures, the reference numeral 1 generally designates a medical device for using an endoscopic instrument for diagnostic or operating purposes, particularly in urology and gynecology.

Such an endoscopic instrument, not shown in the figures, is of the type of a conventional endoscope (fiberscope) provided with a probe containing a bundle of optic fibers and provided with a distal end having an optical lens and with a proximal end associated with a viewing apparatus and with connection means for the supply of electric power to the aforesaid bundle.

Moreover, it should be noted that in the description that follows, the terms "proximal" and "distal" are used with reference to the health facility operator who, during the execution of the examination, is positioned at the aforementioned viewing apparatus.

The device 1 comprises a rigid guiding cannula 2 for the introduction of the probe of the endoscopic instrument and means 3 of barrier protection of the instrument itself at least at the corresponding probe, which are temporarily associable with the cannula 2 and can at least partially be accommodated inside it.

The cannula 2 has a rectilinear inner cavity 4, passing through the respective proximal and distal open ends, the latter being contoured so as to facilitate the insertion into the body of the patient.

The protection means 3 comprise a rectilinear sheath 5, adapted to be fitted over the probe of the endoscopic instrument and made of plastic material.

The sheath 5 can be inserted along the cavity 4 and has a length of the same order of magnitude as the cannula 2, so as to position the corresponding distal end at that of the cannula 2 and the corresponding proximal end proximate to that of the cannula.

The sheath 5 is provided with an optical lens 6 at its distal end, which can be of the soft or hard type and can be oriented differently with respect to the longitudinal axis along which the sheath extends depending on the type of probe employed.

The proximal end of the sheath 5, on the other hand, is associable with the endoscopic instrument.

In particular, the protection means 3 are provided with a tubular end element 7 provided with means 8 of connection to the endoscopic instrument, which has a first end associated with the proximal end of the sheath 5 and a second end, opposite to the first, protruding from the proximal end of the cannula 2.

The end element 7 is preferably made of plastic material and its corresponding through inner cavity is aligned with the one defined by the sheath 5.

The connection means 8 can comprise a female half-coupling of the bayonet type defined on the end element 7 at the corresponding second end, which can engage with a corresponding male half-coupling defined by contoured profiles generally provided on the endoscopic instrument.

In a preferred embodiment, the protection means 3 comprise a tubular enclosure 9, one end of which is integrally associated with the end element 7, for example by way of adhesive bonding, and where the enclosure extends with respect to it in the opposite direction of the sheath 5 so as to cover at least partially the portion of the endoscopic instrument proximate to the probe.

The enclosure 9 is frustum- shaped and open at the ends and is positioned with its end of smaller cross-section associated with the end element 7.

The enclosure 9 is also preferably made of plastic and flexible material.

Advantageously the protection means 3 (constituted by sheath 5, end element 7 and, optionally, enclosure 9) are of the single-use type and make it possible to prevent the contamination of the endoscopic instrument during use, thus making the sterilization thereof, or of its parts, at the end of each treatment superfluous.

The cannula 2 is provided, generally, with a tubular and rectilinear jacket 10, the proximal end of which is integral with a tubular connector 11 provided with at least one port 12 for the introduction of fluids or medical instruments along the interspace comprised between the sheath 5 and the jacket 10.

In the embodiment shown the connector 11 is provided with three ports 12, two of which, indicated with the reference numeral 12a, are provided with valve means for the administration of medical fluids and one, indicated with the reference numeral 12b, provides access for biopsy instruments or the like.

The free ends of the jacket 10 and of the connector 11 define the distal and proximal ends, respectively, of the cannula 2.

The jacket 10 is made of plastic or metallic material and the connector 11, generally made of plastic material, has a corresponding through inner cavity aligned with the one defined by the jacket 10.

The jacket 10 and the connector 11 are connected by way of welding, adhesive bonding or slotting.

The end element 7 can be associated temporarily with the cannula 2 in order to increase the airtightness of the device 1 during use.

Specifically, the end element 7 is contoured so as to define a tubular shank 13 at the end associated with the sheath 5, which can be accommodated with engagement within the connector 11 in the inlet of the cavity 4 at the proximal end of the cannula 2.

Moreover, the connector 11 is provided, at the proximal end of the cannula 2, with a pair of fins 14 on opposite sides, which extend axially and between which the end element 7 is inserted.

The device 1 is provided in a kit that also comprises a conventional mandrel 15 which can be inserted along the cannula 2 temporarily and alternatively to the sheath 5 in order to occlude its cavity 4 in the step of introduction into the body of the patient.

Advantageously the device 1 comprising cannula 2, protection means 3 and mandrel 15 constitutes a single-use kit that must be replaced following every use and preserves the sterility and the functionality of the endoscopic instrument.

The use of the present invention is as follows.

According to conventional operating methods, the operator introduces the cannula 2 pre-assembled with the mandrel 15 inside it into the body of the patient and subsequently extracts the mandrel 15 while keeping the cannula 2 in position.

At this point the operator positions the protection means 3 on the endoscopic instrument, fitting the sheath 5 over the corresponding probe until the lens 6 is brought into abutment against the lens of the instrument itself, and fixes the connection means 8. Naturally the sheath 5 must be dimensioned according to the geometry of the probe, so as to have a corresponding length.

If the enclosure 9 is present then the probe of the endoscopic instrument is caused to pass through it, and it remains as a protection of the proximal part of the instrument.

The probe with the corresponding protection means 3 is then inserted into the cavity 4 along the cannula 2 and the operator can carry out the intervention or examination as usual.

Once the process has been concluded and the probe with the protection means 3 and the cannula 2 is extracted, the components of the device 1 must be disposed of while the endoscopic instrument is immediately available for a new treatment.

In practice it has been found that the invention as described achieves the intended aim and objects and, in particular, attention is drawn to the fact that the device according to the invention makes the sterilization of the endoscopic instrument superfluous and, therefore, it makes it possible to increase the number of services that can be performed, to reduce operating costs and to preserve the functionality of the instrument itself.

The invention, thus conceived, is susceptible of numerous modifications and variations, all of which are within the scope of the appended claims.

Moreover, all the details may be substituted by other, technically equivalent elements.

In practice the materials employed, as well as the contingent dimensions and shapes, may be any according to requirements but without for this reason extending beyond the scope of protection of the following claims.

The disclosures in Italian Utility Model Application No. MO2010U000025 from which this application claims priority are incorporated herein by reference.

Where technical features mentioned in any claim are followed by reference signs, those reference signs have been included for the sole purpose of increasing the intelligibility of the claims and accordingly, such reference signs do not have any limiting effect on the interpretation of each element identified by way of example by such reference signs.

Claims

1. A medical device (1) for using an endoscopic instrument for diagnostic or operating purposes, particularly in urology and gynecology, comprising a rigid guiding cannula (2) for the introduction of the probe of an endoscopic instrument, characterized in that it comprises means (3) of barrier protection of said endoscopic instrument at least at said probe, which are temporarily associable with said cannula (2) and can at least partially be accommodated inside it.

2. The device (1) according to claim 1, characterized in that said protection means (3) comprise a sheath (5) adapted to cover said probe, which can be inserted along said cannula (2) and is provided with a distal end having an optical lens (6) and with a proximal end that can be associated with said endoscopic instrument.

3. The device (1) according to claim 2, characterized in that said lens (6) is of the soft or hard type.

4. The device (1) according to one or more of the preceding claims, characterized in that said protection means (3) comprise a tubular end element (7) provided with means (8) of connection to said endoscopic instrument, which is associated with the proximal end of said sheath (5) and protrudes from the proximal end of said cannula (2).

5. The device (1) according to claim 4, characterized in that said connection means (8) comprise a female half-coupling of the bayonet type, the endoscopic instrument being provided with the corresponding male half- coupling.

6. The device (1) according to one or more of the preceding claims, characterized in that said protection means (3) comprise a tubular enclosure (9), having one end which is integral with said end element (7) and another end which is free for the insertion of said endoscopic instrument and extends at the opposite side of said sheath (5) with respect to said end element, which is adapted to cover at least partially the proximal portion of said endoscopic instrument.

7. The device (1) according to claim 1, characterized in that said cannula (2) comprises a tubular jacket (10) whose proximal end is associated with a tubular connector (11) provided with at least one port (12) for the introduction of fluids or medical instruments along the interspace comprised between said sheath (5) and the said jacket, the free ends of the jacket (10) and of the connector (11) defining the distal and proximal ends respectively of the cannula (2).

8. The device (1) according to one or more of the preceding claims, characterized in that said end element (7) can be associated temporarily with said cannula (2).

9. The device (1) according to claims 7 and 8, characterized in that said end element (7) is contoured so as to define a tubular shank (13) that can be accommodated with engagement within said connector (11) at the proximal end of said cannula (2).

10. The device (1) according to one or more of the preceding claims, characterized in that it comprises a mandrel (15) that can be inserted along said cannula (2) temporarily and alternatively to said sheath (5).