WO2015140065A1

WO2015140065A1 - Protection device for diagnostic instruments of the optical type and corresponding method of manufacture

Info

Publication number: WO2015140065A1
Application number: PCT/EP2015/055296
Authority: WO
Inventors: Carlo Alberto Bosi
Original assignee: X-MED Srl
Current assignee: X-MED Srl
Priority date: 2014-03-17
Filing date: 2015-03-13
Publication date: 2015-09-24
Anticipated expiration: 2016-09-17

Abstract

A protection device (1) for diagnostic instruments of the optical type, of the type comprising a viewing lens, the protection device comprising a neutral lens (2) that is transparent and deformable and is adapted to be arranged so as to adhere to the viewing lens during use of the diagnostic instrument.

Description

PROTECTION DEVICE FOR DIAGNOSTIC INSTRUMENTS OF THE OPTICAL TYPE AND CORRESPONDING METHOD OF MANUFACTURE

The present invention relates to a protection device for diagnostic instruments of the optical type and a corresponding method of manufacture.

In the medical sector diagnostic instruments of the optical type are known, such as for example conventional endoscopes, which are used to explore inner organs or cavities of the human body in various different fields of medicine including, for example, urology, gynecology, gastroenterology and pneumology.

Such endoscopes are substantially constituted by a viewing device, arranged at the proximal end with respect to the operator in conditions of use, which is connected to a lens, arranged at the distal end, by way of a tube for transmitting the images which is adapted to be inserted in the human body. Such tube can be rigid or flexible, for example it can be constituted by optical fibers.

In order to avoid the need to sterilize such instruments at each use, for some time it has been known to apply disposable protection sheaths, which are replaced at each use, to endoscopes, in particular on the tube and lens.

Such sheaths are essentially constituted by tubular cannulas that are adapted to be fitted over the tube of the endoscope and are optionally provided with systems for anchoring to the proximal end of the endoscope. The sheaths are provided at their ends with neutral lenses to cover and protect the viewing lens of the instrument.

The sheaths according to the known art involve the use of rigid lenses, made of plastics or glass, which are constituted by the bottom wall of an element that is substantially beaker-shaped so as to define a cylindrical outer shell that acts as a support of the lens and is connected to the tubular cannula by way of heat-sealing or gluing.

For the correct operation of the optical instrument it is necessary that the neutral lens be positioned so as to adhere perfectly to the viewing lens of the instrument, in order to prevent phenomena of diffraction of the light between the two lenses, which could alter the image detected.

Such conventional sheaths are not devoid of drawbacks, among which is the fact that the rigidity of the covering lens makes it difficult to correctly position the sheath on the instrument, with the neutral lens adhering perfectly to the viewing lens of the endoscope, and to maintain it during use of the endoscope.

In the event of accidental movements, the image detected in the carrying out of a diagnostic investigation may be altered, thus not permitting the operator to correctly read it and, as a consequence, penalizing the reliability of the investigation.

If the operator encounters a malfunction owing to a movement of the lenses, most of the time he/she is forced to extract the instrument from the patient in order to reposition the sheath and resume the diagnostic procedure later, with considerable inconvenience for the patient and evident lengthening of the execution times of the investigation.

Last but not least, the shape structure of the neutral lens for protection must correspond to that of the viewing lens of the endoscope, in order to have a placement in which the lenses fit together. Therefore different types of sheaths must be provided according to the characteristics of the viewing lens in use, with consequent problems of managing a plurality of articles both for the manufacturing firms and for the users.

The aim of the present invention is to eliminate the above mentioned drawbacks of the background art by providing a protection device for diagnostic instruments of the optical type, as well as a corresponding method of manufacture, which makes it possible to facilitate the correct positioning of the device with respect to the instrument and to ensure the maintenance of such positioning during the normal use thereof.

Within this aim, an object of the present invention is to optimize the reliability of the diagnostic results obtained.

Another object of the present invention is to avoid inconvenience for the patients during the carrying out of diagnostic investigations, and lengthening of execution times owing to accidental movements of the protection lens with respect to the viewing lens.

Another object of the present invention is to increase the flexibility of use of the device, by reducing the number of articles to manage both for the manufacturing firms and for the users.

Another object of the present invention is to provide a simple structure that is easy and practical to implement, safe in use and effective in operation, and low cost.

This aim and these and other objects that will become more apparent hereinafter, are achieved by the present protection device for diagnostic instruments of the optical type with a viewing lens, which comprises a substantially tubular supporting body with the distal end of which a neutral lens is associated which is adapted to be arranged so as to adhere to the viewing lens of the optical instrument, characterized in that said neutral lens is made of deformable material.

Advantageously, on the deformable material there is an end element that is provided with a central portion that defines the neutral lens, and a perimetric portion that extends along the peripheral region of the central portion. The supporting body can comprise an inner bushing and an outer bushing, which are arranged one inside the other and between which is an annular cavity for retaining the perimetric portion, the central portion being positioned at the axial hole of the inner bushing and resting perimetrically on the distal end of the inner bushing.

The thickness of the annular cavity is substantially less than that of the perimetric portion, the end element being retained between the inner and outer bushings by interference.

This aim and these and other objects that will become better apparent hereinafter are also all achieved by the present method for manufacturing a protection device for diagnostic instruments of the optical type, of the type comprising a viewing lens, characterized in that it comprises the steps of:

- providing a protective end element made of transparent and deformable material, which has a central portion that defines a neutral lens that is adapted to be arranged so as to adhere to said viewing lens during use and a perimetric portion that extends along the peripheral region of said central portion,

- providing a body for supporting said neutral lens, which comprises an inner bushing and an outer bushing, the inner bushing being insertable inside said outer bushing with a play that is substantially smaller than the thickness of said perimetric portion,

- juxtaposing said outer bushing and said inner bushing so that they are mutually coaxial and spaced apart and said end element is interposed between said bushings with said central portion at the axial hole of said inner bushing, and

- assembling said outer bushing on said inner bushing so as to accommodate said perimetric portion between them, the end element being rendered integral by interference with said supporting body so as to obtain a one piece device.

Further characteristics and advantages of the present invention will become better apparent from the detailed description of two preferred, but not exclusive, embodiments of a protection device for diagnostic instruments of the optical type and a corresponding method of manufacture, which are illustrated for the purposes of non-limiting example in the accompanying drawings wherein:

Figure 1 is a schematic cross-sectional view taken along a longitudinal plane of a first embodiment of a protection device according to the invention;

Figures 2 and 3 are schematic cross-sectional views taken along a longitudinal plane, respectively, of the inner and outer bushings of the device in Figure 1 ;

Figure 4 is a schematic cross-sectional view taken along a longitudinal plane, of the juxtaposing step of the method of manufacture according to the invention;

Figure 5 is a perspective view of Figure 4;

Figure 6 is a schematic cross-sectional view taken along a longitudinal plane, of the assembly step of the method of manufacture according to the invention;

Figure 7 is a schematic cross-sectional view taken along a longitudinal plane, of the application step of the method of manufacture according to the invention;

Figure 8 is a schematic cross-sectional view taken along a longitudinal plane, of a second embodiment of the device according to the invention.

With reference to the figures, the reference numeral 1 generally designates a protection device for diagnostic instruments of the optical type which comprise a viewing lens, such as conventional endoscopes which are not shown in the figures since they are of known type.

The device 1 comprises a neutral lens 2 that is adapted to be arranged so as to adhere to the viewing lens of the diagnostic instrument to be protected during use, and a substantially tubular supporting body the distal end of which is associated with the neutral lens 2.

In the description that follows the terms "distal" and "proximal" are used with reference to the position of the operator during the use of the device 1 applied to a diagnostic instrument.

In more detail, the device 1 comprises a protective end element 4 made of transparent and deformable material, which is provided with a central portion 4a that defines the neutral lens 2 and a perimetric portion 4b that extends along the peripheral region of the central portion 4a. Advantageously the perimetric portion 4b extends continuously on the peripheral region of the central portion 4a.

The end element 4 can be constituted by a piece of film, for example, made of polythene, polypropylene, polycarbonate or multilayer transparent polymers, with a thickness indicatively comprised between 0.01 mm and 0.04 mm.

The supporting body 3 comprises an inner bushing 5 and an outer bushing 6 which are arranged one inside the other and between which there is an annular cavity 7 for retaining the perimetric portion 4b. The thickness of the annular cavity 7 is preferably less than that of the perimetric portion 4b so that the latter is retained by interference.

The central portion 4a is positioned at the axial hole 8 of the inner bushing 5 and resting perimetrically on the distal end 5a of the inner bushing.

For this reason the distal end 5a of the inner bushing 5 is preferably beveled outwardly so as to not damage the end element 4 which, if it was torn, could cause the contamination of the diagnostic instrument.

In this manner a device 1 is obtained which is provided with a soft neutral lens 2, which can deform following a light pressure exerted when fitting the device 1 onto the diagnostic instrument, so as to perfectly fit together with any type of viewing lens and keep it adhered thereto during use.

The deformation is preferably of the elastic or elastoplastic type, according to the material used.

Advantageously there are axial coupling means 9 interposed between the inner 5 and outer 6 bushings, so as to strengthen the connection by interference obtained between them by interposition of the perimetric portion 4b.

The coupling means 9 are of the type that act by obstacle, and have at least one profile 10 that extends in an annular direction and protrudes from one of the inner wall of the outer bushing 6 or the outer wall of the inner bushing 5 and a corresponding recessed groove 11 on the other of the inner wall of the outer bushing 6 or the outer wall of the inner bushing 5. At least one of the inner 5 and outer 6 bushings is made of elastically flexible material in order to allow the mating of the coupling means 9.

For example, the material used can be polythene, polypropylene, the styrene-butadiene block copolymer commercially available as Styroflex, polystyrene, polycarbonate, PVC or another plastic material.

In the embodiments shown, the coupling means 9 have an annular profile 10 that extends on the outer wall of the inner bushing 5 and a corresponding annular groove 11 defined on the inner wall of the outer bushing 6, which is made of elastically flexible material.

In addition to or in substitution of the coupling means 9, the bushings 5 and 6 and the end element 4 can be bonded together, by way of sealing or heat-sealing by ultrasound, radio frequency or laser, or by interposing adhesive means.

The outer bushing 6 has a longitudinal extension that is such as to present the corresponding distal end 6a positioned axially at the distal end 5a of the inner bushing 5, so as to cover the perimetric portion 4b on the outer side and preserve its integrity, in addition to favoring its retention.

The axial extension of the outer bushing 6 is lower than that of the inner bushing 5, which is provided with an annular seat 12, which extends axially from the corresponding distal end 5a, for the accommodation of the outer bushing 6, so that the outer surface of the supporting body 3 defined by the bushings proper is substantially free from discontinuities at least up to the vicinity of the corresponding distal end 3a. In this manner the proximal end 6b of the outer bushing 6 abuts on the bottom shoulder 13 of the seat 12.

Figure 1 shows a first embodiment of the device 1 which also comprises a tubular cannula 14 that is associated with the supporting body 3 and protrudes from the corresponding proximal end 3b, arranged opposite the distal end 3 a, in order to cover the tube of the diagnostic instrument.

The cannula 14 is fitted over the supporting body 3 and the outer bushing 6 has, proximate to the corresponding distal end 6a, an annular raised portion 15 that protrudes outwardly for the abutment of the cannula.

The cannula 14 can be connected to the outer wall of the supporting body 3 by way of gluing or heat-sealing.

In a second embodiment (Figure 8) the inner bushing 5 proper extends toward the proximal area and acts as a cover for the tube of the diagnostic instrument without involving the use of further elements.

The method of manufacture of the device 1 involves supplying the end element 4 and the bushings 5 and 6 which make up the supporting body 3.

It should be noted that the end element 4 can be supplied in the form of a piece of film, initially flat, to be deformed in the assembly step, or it can be preformed, assuming a beaker shape.

Subsequently the bushings 5 and 6 are juxtaposed coaxially and spaced apart, with the end element 4 interposed with the corresponding central portion 4a at the axial hole 8 (Figures 4 and 5).

Subsequently the assembly is executed by inserting the outer bushing

6 on the inner bushing 5, so as to accommodate the perimetric portion 4b between such bushings (Figure 6). In this manner the end element 4 is rendered integral with the bushings 5 and 6 by interference so as to obtain a single piece.

Such assembly step can be carried out manually or by way of pressing devices fitted with dies and with corresponding automatic loading systems.

If adhesive means are to be interposed between the end element 4 and the bushings 5 and 6, then such items must be arranged before the assembly.

The bonding step, if any, is carried out after the assembly.

At the same time as the assembly, there can be a step of insertion of a punch die along the axial hole 8 toward the central portion 4a, until the tip of the punch die is positioned to protrude beyond the distal end 3a by a few millimeters, for example by 5mm, so as to deform the portion. Such punch die simulates the shape of the distal end of the diagnostic instrument to which the device 1 is to be applied, so as to deform the central portion 4a until it assumes an outward convex shape, so as to adapt to the beveled shape structure of some instruments. In this manner it is possible to keep the thickness of the film low and obtain a perfect mating between the neutral lens 2 and the viewing lens.

If the device 1 has the cannula 14 (Figure 1), the latter is applied to the supporting body 3 by way of heat-sealing or gluing after assembly (Figure 7).

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 it possible to obtain a deformable neutral lens that is capable of perfectly adhering to the viewing lens of the diagnostic instrument following a light pressure and remaining in the correct position during use. Furthermore, this characteristic gives the device according to the invention the possibility of being used universally, independently of the shape structure of the viewing lens.

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 without for this reason departing from the scope of protection claimed herein.

The disclosures in Italian Patent Application No. MO2014A000068 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 protection device (1) for diagnostic instruments of the optical type with a viewing lens, which comprises a substantially tubular supporting body (3) with the distal end (3 a) of which a neutral lens (2) is associated which is adapted to be arranged so as to adhere to said viewing lens of said optical instrument, characterized in that said neutral lens (2) is made of deformable material.

2. The protection device according to claim 1, characterized in that said deformable material comprises an end element (4) that has a central portion (4a) that defines said neutral lens (2) and a perimetric portion (4b) that extends along the peripheral region of said central portion (4a), and in that said supporting body (3) comprises an inner bushing (5) and an outer bushing (6), which are arranged one inside the other and between which there is an annular cavity (7) for retaining said perimetric portion (4b), the central portion (4a) being arranged at the axial hole (8) of said inner bushing (5) and resting perimetrically on the distal end (5a) of said inner bushing.

3. The device (1) according to claim 2, characterized in that the thickness of said annular cavity (7) is substantially less than that of said perimetric portion (4b), the end element (4) being retained between the inner (5) and outer (6) bushings by interference.

4. The device (1) according to claim 2 or 3, characterized in that it comprises axial coupling means (9), which are interposed between said inner (5) and outer (6) bushings.

5. The device (1) according to claim 4, characterized in that said coupling means (9) comprise at least one profile (10) that extends in an annular direction and protrudes from one of the inner wall of said outer bushing (6) and the outer wall of said inner bushing (5) and a corresponding recessed groove (11) on the other of the inner wall of said outer bushing (6) or the outer wall of said inner bushing (5), one or both of the inner bushing (5) and the outer bushing (6) being made of elastically flexible material so as to allow the mating of the coupling means (9).

6. The device (1) according to one or more of claims 2 to 5, characterized in that the distal end (5a) of said inner bushing (5) is beveled outwardly.

7. The device (1) according to one or more of claims 2 to 6, characterized in that said outer bushing (6) has the corresponding distal end (6a) arranged axially at the distal end (5a) of said inner bushing (5).

8. The device (1) according to one or more of claims 2 to 7, characterized in that said outer bushing (6) has a smaller axial extension than said inner bushing (5), the inner bushing (5) having an annular seat (12) for accommodating the outer bushing (6) so as to define an outer surface of said supporting body (3) that is substantially free from discontinuities at least up to the vicinity of the corresponding distal end (3a).

9. The device (1) according to one or more of the preceding claims, characterized in that it comprises a cannula (14) that is associated with said supporting body (3) and protrudes from the corresponding proximal end (3b), which is arranged opposite the distal end (3a).

10. The device (1) according to claim 8, characterized in that said cannula (14) is fitted on said supporting body (3) and in that said outer bushing (6) comprises an annular raised portion (15) that protrudes outwardly proximate to the corresponding distal end (6a) for the abutment of said cannula.

11. A method for manufacturing a protection device (1) for diagnostic instruments of the optical type, of the type comprising a viewing lens, characterized in that it comprises the steps of:

- providing a protective end element (4) made of transparent and deformable material, which has a central portion (4a) that defines a neutral lens (2) that is adapted to be arranged so as to adhere to said viewing lens during use and a perimetric portion (4b) that extends along the peripheral region of said central portion (4a),

- providing a body (3) for supporting said neutral lens (2), which comprises an inner bushing (5) and an outer bushing (6), the inner bushing (5) being insertable inside said outer bushing (6) with a play that is substantially smaller than the thickness of said perimetric portion (4b),

- juxtaposing said outer bushing (6) and said inner bushing (5) so that they are mutually coaxial and spaced apart and said end element (4) is interposed between said bushings with said central portion (4a) at the axial hole (8) of said inner bushing (5), and

- assembling said outer bushing (6) on said inner bushing (5) so as to accommodate said perimetric portion (4b) between them, the end element (4) being rendered integral by interference with said supporting body (3) so as to obtain a one piece device (1).

12. The method according to claim 11 , characterized in that it comprises applying a cannula (14) fitted on said outer bushing (6).

13. The method according to claim 11 , characterized in that it comprises inserting a punch die within said axial hole until said central portion is deformed, said insertion being performed simultaneously with said assembly operation.