WO2001049180A1

WO2001049180A1 - Hygienic protection element for medical instruments

Info

Publication number: WO2001049180A1
Application number: PCT/IB2000/000629
Authority: WO
Inventors: Roberto Semani
Original assignee: Roberto Semani
Priority date: 1999-12-30
Filing date: 2000-05-11
Publication date: 2001-07-12
Also published as: ITUD990069U1; AU4140300A; ITUD990069V0; IT248084Y1

Abstract

Hygienic protection element (10) for medical instrument (13) such as phonendoscopes, stethoscopes, instruments to measure blood pressure or otherwise, comprising at least a film (11), made of non-toxic material, able to be applied through temporary adherence to the part (13a) of the medical instrument (13) cooperating with the patient's body, or to the body of the patient himself, and being interposed between the latter and the part (13a) in order to prevent direct contact.

Description

HYGIENIC PROTECTION ELEMENT FOR MEDICAL INSTRUMENTS

* * * * * FIELD OF THE INVENTION

The invention concerns a hygienic protection element for medical instruments such as phonendoscopes, stethoscopes, instruments to measure blood pressure or otherwise, able to be applied to said instruments to prevent direct contact with the patient's skin, in order to prevent the transmission of skin pathologies from one patient to another .

BACKGROUND OF THE INVENTION It is well-known that medical instruments, particularly those for auscultation, such as phonendoscopes, stethoscopes or similar, and those to measure blood pressure, are used in direct contact with the patients' skin.

Between one examination and the next, however, it is not possible to sterilize or disinfect the instrument, which in practice is therefore used for a plurality of patients without any hygienic precautions being taken.

This entails an increased risk of transmission of illnesses from one patient to another, especially in the case that one of them is affected by skin pathologies, such as mycosis or similar, which are easily transmitted through contact .

Using paper handkerchiefs or pieces of cloth, interposed between the instrument and the patient's skin has not proved satisfactory, because it only partly solves the problem of hygiene and moreover causes a modification to and/or deadening of the sounds to be auscultated.

The present Applicant has devised and embodied this invention to overcome these shortcomings and to obtain further advantages .

SUMMARY OF THE INVENTION The invention is set forth and characterized in the main claim, while the dependent claims describe other characteristics of the invention.

The purpose of the invention is to achieve a single-use hygienic protection element which can be applied to medical instruments in order to prevent direct contact between the latter and the patient, and thus to prevent the transmission of pathologies which can spread through contact from one patient to another.

Another purpose of the invention is to provide a hygienic protection element which will keep the medical instrument to which it is applied functional and practical to use. The hygienic protection element according to the invention is particularly suitable to be used with medical instruments for auscultation, such as stethoscopes, phonendoscopes or similar, and with instruments to measure blood pressure.

It comprises at least a film, made of non-toxic material, able to be applied through temporary adherence to the part of the medical instrument cooperating with the patient ' s body.

According to a preferential embodiment of the invention, this film is made of plastic material such as polypropylene (PP) , polyethylene (PE) or polymethylpentene (PMP) .

According to a variant, the film is at least partly made of latex.

According to the invention, the film is associated with a support from which it is able to be removed at the moment of application.

In one embodiment of the invention, the film is associated with a mating flexible support comprising at least a central portion able to be removed at the moment of use to uncover a corresponding zone of film to be applied to the instrument through adherence.

The remaining perimeter portion of the flexible support, on the contrary, is permanently associated with the film and allows the hygienic protection element to be applied better and more easily removed.

According to a variant, the film is made, or comprises at least a part, of partly elastic material and is constrained to a rigid-type support. According to another variant, the film is supplied either in a strip or in a roll and comprises lines of preferential breakage, along which it can be torn to obtain individual films of a size and conformation suitable to be applied to the medical instrument . According to the invention, the compact, non-permeable structure of the film prevents any contamination of the medical instrument which therefore, after the hygienic protection element has been replaced, can be re-used without needing any cleaning, disinfecting or sterilizing. Since the film is applied to the medical instrument through adherence, the conformation is substantially not modified, and therefore the ease of handling and the functionality thereof also remains substantially unchanged.

This functionality is also ensured in the medical instruments for auscultation, since using this type of film does not modify and does not deaden the sound waves produced by the patient's body.

BRIEF DESCRIPTION OF THE DRAWINGS These and other characteristics of the invention will become clear from the following description of a preferential form of embodiment, given as non-restrictive examples, with reference to the attached drawings wherein: Fig. 1 is a partly sectioned side view of a hygienic protection element according to the invention applied to a phonendoscope/stethoscope; Fig. 2 is a three dimensional view of a hygienic protection element according to the invention; Fig. 3 shows one step in the application of the hygienic protection element shown in Figs. 1 and 2 ; Fig. 4 shows a variant of the hygienic protection element according to the invention; Fig. 5 shows the hygienic protection element of Fig. 4 applied to a phonendoscope/stethoscope;

Figs. 6 and 7 show two variants of Fig. 4 ; Fig. 8 shows another embodiment of the hygienic protection element according to the invention; Fig. 9 shows a series of hygienic protection elements supplied in a strip in a further embodiment of the invention; Fig. 10 shows a single hygienic protection element from Fig.

9; Fig. 11 is a side view of the hygienic protection element of Fig. 10 applied to a phonendoscope/stethoscope;

Fig. 12 shows a hygienic protection element according to the invention for instruments to measure blood pressure; Fig. 13 shows a strip of hygienic protection elements of the type shown in Fig. 12; Fig. 14 shows a roll of hygienic protection elements of the type shown in Fig. 12; Fig. 15 shows an application of the hygienic protection element of Fig. 12.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENT With reference to the attached Figures, a hygienic protection element 10 according to the invention is able to be applied to a medical instrument to prevent the direct contact between said instrument and the patient . In the case of Figs. 1-11, the hygienic protection element

10 is able to be applied to a phonendoscope/stethoscope 13, while in the case of Figs. 12-14 the hygienic protection element 10 is able to be used for an instrument to measure blood pressure.

The hygienic protection element 10 according to the invention is of the single-use type and is advantageously supplied in individual sterile packages (not shown) .

According to a variant, the hygienic protection elements 10 can be supplied in strips 18, 22 (Figs. 9 and 13) or in a roll 24 (Fig. 14) from which they can be individually detached when they are needed for use.

In the embodiment shown in Figs. 1-3, the hygienic protection element 10 comprises a thin film 11, made of a substantially adherent and non-toxic material, associated to the main surface of a flexible support 12, for example made of shiny paper.

The film 11 is advantageously made of plastic material, for example polypropylene (PP) , polyethylene (PE) or polymethylpentene (PMP) .

The film 11 is of a size and shape suitable for it to be applied to the part of the medical instrument which comes into contact with the patient's body.

In this case, the film 11 is circular in shape and has a diameter "D" of between 70 mm and 100 mm, so that it can be applied through adherence to the lower side of the resounding chamber 13a of the phonendoscope/stethoscope 13 and wrap it partly at the side too.

The flexible support 12 has the same size and shape as the film 11 and comprises a central portion 12a, circular in shape and with a diameter "d" which is larger than that of the resounding chamber 13a, and a perimeter portion 12b of an annular shape (Fig. 2) . In a preferential embodiment, the central portion 12a has a diameter of between 6C mm and 80 mm.

The central portion 12a is pre-cut on the perimeter, so as to be removable, and therefore can be separated from the film 11 and from the perimeter portion 12b, so that the hygienic protection element 10 can be applied.

In the preferential embodiment shown, the central portion 12b is provided with a strip 14 which allows it to be removed more easily (Fig. 2) . The perimeter portion 12b is permanently associated with the film 11, for example by gluing.

With reference to the application to the phonendoscope/ stethoscope 13, the hygienic protection element 10 is used in the following manner. The central portion 12a of the flexible support 12 is removed, and the corresponding uncovered zone of the film 11 is rested on the lower side of the resounding chamber 13a (Figs. 1 and 3) .

The film 11 is firstly disposed to adherently contact the perimeter portion 12b of the resounding chamber 13a, and subsequently wound laterally until it adheres well to the instrument (Fig. 1) .

In this condition, where the film 11 is taut on the lower side of the resounding chamber 13a, while it is raised from the instrument in correspondence with the perimeter portion 12b, the phonendoscope/stethoscope 13 can be used.

At the end of the examination, the hygienic protection element 10 can be removed easily by gripping the perimeter portion 12b which, since it does not adhere to the resounding chamber 13a, facilitates this operation.

In the variant shown in Figs. 4 and 5, the film 11 is made of latex and it is wound, when the hygienic protection element 10 is not in use, on a rigid support 15 consisting of a disk, for example made of cardboard or plastic.

To be more exact, the film 11 has a circumferential edge

11a which, due to the elasticity of the latex, narrows towards the inside and is folded back on the periphery of the upper side 15a of the rigid support 15, making the film

11 adhere to the lower side 15b of the rigid support 15.

In this case, the film 11 is applied to the phonendoscope/ stethoscope 13 by rotating the latter upwards and by resting the hygienic protection element 10, on the side wherein the film 11 completely covers the rigid support 15, on the resounding chamber 13a.

Subsequently the circumferential edge 11a of the film 11 is folded back onto the resounding chamber 13a so that it is constrained in correspondence with the narrower part 13b of the resounding chamber 13a itself (Fig. 5); then the rigid support 15 is removed and the phonendoscope/stethoscope 13 is ready for use.

In this condition the lower portion of the resounding chamber 13a, that is, the one which is rested on the patient's body, is completely wrapped in the film 11.

The side of the film 11 facing outwards, which at the moment when the phonendoscope/stethoscope 13 is used will come into contact with the patient's body, is the one which was previously covered by the rigid support 15 and is therefore hygienically protected.

In the variant shown in Fig. 6, the central portion of the film 11 is made of plastic material, as shown in the case of Figs. 1-3, and its perimeter edge 11a is made of latex.

By means of said perimeter edge 11a the film 11 is kept adherent to the rigid support 15 when the hygienic protection element 10 is not in use and is able to be constrained to the phonendoscope/stethoscope 13 when it is applied thereto. In the variant shown in Fig. 7, the hygienic protection element 10 comprises a film 11 made of latex which is temporally associated to a rigid support 15 shaped like a circular crown to which the circumferential edge 11a is able to be constrained.

In the embodiment shown in Fig. 8, the hygienic protection element 10 comprises a film 11 defining a hollow body of a shape mating with that of the resounding chamber 13a and with a circular aperture 16 through which the resounding chamber 13a can be introduced inside said hollow body.

On the circumference of the aperture 16 there is an elastic element 17 able to be positioned in correspondence with the narrower part 13b of the resounding chamber 13a to make the film 11 adhere better thereto. In the embodiment shown in Fig. 9, there is a support 18 for a plurality of films 11 made of plastic material to be applied to phonendoscope/stethoscope 13.

The support 18 consists of a long strip of flexible material to which the films 11 are applied through adherence.

Each film 11 has a width mating with the diameter of the resounding chamber 13a to which it must be applied and, at one end, is associated with a bow-shaped adhesive strip 20 covered at the upper part by a removable edge 19. In this embodiment, the film 11 is applied by resting the resounding chamber 13a on the upper side of the film 11 (Fig. 10), then by removing the edge 19 and folding back the uncovered adhesive strip 20 onto the resounding chamber 13a; then the film 11 is wound around the resounding chamber 13a and made to adhere (Fig. 11) .

Figs. 12-15 show a hygienic protection element 10 used in association with instruments to measure blood pressure.

The hygienic protection element 10 comprises a rectangular film 11 of a size such as to be able to be wound around the patient's arm 21, covering it in correspondence with the zone where the medical instrument will be applied.

In this case too, the film 11 has an adhesive strip 20, which extends for the whole of its short side, covered by an edge 19 of the removable type (Fig. 12) .

This hygienic protection element 10 is applied simply by making the film 11 adhere around the patient's arm 21, then removing the edge 19 and sticking the adhesive strip 20 onto the film 11, so that the latter is kept taut and adherent

(Fig. 15) .

Fig. 13 shows a strip 22 consisting of a plurality of hygienic protection elements 10 of the type shown in Fig. 12; they are supplied joined together in correspondence with the short side.

In this embodiment every hygienic protection element 10 can be individually detached from the strip 22 in correspondence with a line of preferential breakage 23 made at the side of the adhesive strip 20. Fig. 14 shows a roll 24, associated with a handle 25, also consisting of a plurality of hygienic protection elements 10 for instruments to measure blood pressure.

In this case too it is possible to separate an individual hygienic protection element 10 thanks to the lines of preferential breakage 23.

It is obvious however that modifications and/or additions may be made to the hygienic protection element 10 as described heretofore but these shall remain within the field and scope of the invention. For example, it may be of different sizes and/or shapes, according to the instrument to which it has to be applied or with which it is able to cooperate.

Or, in the embodiment shown in Figs. 1-3, the perimeter portion 12b of the flexible support 12 may be a different color from the centra] portion 12a and/or the film 11, so as to be identified more immediately.

Moreover, the hygienic protection element 10 can be associated also by making the film 11 adhere completely to the instrument and by leaving the perimeter portion 12b of the flexible support 12 on the outside.

It is also obvious that, although this invention has been described with reference to specific examples, a person of skill in the art shall certainly be able to achieve many other equivalent forms of hygienic protection element, all of which shall come within the field and scope of this invention.

Claims

1 - Hygienic protection element for medical instruments (13) such as phonendoscopes, stethoscopes, instruments to measure blood pressure or otherwise, characterized in that it comprises at least a film (11), made of non-toxic material, able to be applied through temporary adherence to the part

(13a) of the medical instrument (13) cooperating with the patient's body, or to the body of the patient himself, and being interposed between the latter and the part (13a) in order to prevent direct contact.

2 - Hygienic protection element as in Claim 1, characterized in that said film (11) is made of plastic material such as polypropylene (PP) , polyethylene (PE) or polymethylpentene

(PMP) . 3 - Hygienic protection element as in Claim 1, characterized in that said film (11) is at least partly made of latex or similar elastic material.

4 - Hygienic protection element as in Claim 1, characterized in that said film (11) is associated with a relative support (12, 15, 18) from which it can be separated for use.

5 - Hygienic protection element as in Claim 4, characterized in that said film (11) is associated through adherence with a flexible support (12) with substantially the same shape, said flexible support (12) being able to be removed at least partly from said film (11) to allow it to be applied to said part ( 13a) .

6 - Hygienic protection element as in Claim 5, characterized in that said flexible support (12) comprises a central portion (12a), able to be removed from said film (11) to uncover a zone thereof which is able to adhere to said part (13a), and a perimeter portion (12b) permanently associated with said film (11) .

7 - Hygienic protection element as in Claim 6, characterized in that the zone of said film (11) uncovered by removing said central portion (12a) is also able to adhere at least to a lateral segment of said part (13a) .

8 - Hygienic protection element as in Claim 6, characterized in that said central portion (12a) is provided with a strip

(14) able to facilitate removal.

9 - Hygienic protection element as in Claim 6, characterized in that said perimeter portion (12b) is associated with said film (11) by gluing. 10 - Hygienic protection element as in Claim 6, characterized in that said perimeter portion (12b) is a different color from said central portion (12a) and/or said film (11) .

11 - Hygienic protection element as in Claim 5, characterized in that said film (11) and said flexible support (12) have a substantially circular shape.

12 - Hygienic protection element as in Claim 11, characterized in that said film (11) and said flexible support (12) have a diameter ("D") of between 70 mm and 100 mm.

13 - Hygienic protection element as in Claims 6 and 12, characterized in that said central portion (12a) is circular in shape and has a diameter ("d") of between 60 mm and 80 mm. 14 - Hygienic protection element as in Claim 5, characterized in that said flexible support (12) is made of paper or similar material.

15 - Hygienic protection element as in Claim 4, characterized in that said film (11) is associated with a flexible support in a strip (18) or in a roll on which a plurality of identical films (11) are associated.

16 - Hygienic protection element as in Claim 4, characterized in that said film (11) is associated with a rigid support (15) from which it is able to be completely removed during use .

17 - Hygienic protection element as in Claims 3 and 16, characterized in that said film (11) is provided at least with an edge (11a) made of latex or similar elastic material able to be constrained on the periphery of said rigid support (15 ) .

18 - Hygienic protection element as in Claim 17, characterized in that said edge (11a) is able to be constrained on said part (13a) when said film is applied to said instrument (13).

19 - Hygienic protection element as in Claim 16, characterized in that said rigid support (15) is made of cardboard or plastic. 20 - Hygienic protection element as in Claim 16, characterized in that said rigid support (15) is disk- shaped.

21 - Hygienic protection element as in Claim 16, characterized in that said rigid support (15) is shaped like a circular crown.

22 - Hygienic protection element as in Claim 1, characterized in that said film (11) defines a hollow body, with at least an aperture (16), inside which said part (13a) is able to be introduced. 23 - Hygienic protection element as in Claim 22, characterized in that said aperture (16) is peripherally associated with elastic means (17) .

24 - Hygienic protection element as in Claim 1, characterized in that said film (11) is able to wrap at least partly said part (13a) or the segment (21) of the patient's body with which the medical instrument is able to cooperate .

25 - Hygienic protection element as in Claim 1, characterized in that said film (11) is associated with at least an adhesive strip (20) covered by a removable edge

(19), said adhesive strip (20) being able to be glued to said part (13a) or to a defined segment of said film (11) when the latter is being applied.

26 - Hygienic protection element as in Claim 1, characterized in that said film (11) is temporally associated with a plurality of other, identical films (11) so as to define a strip (22) . 27 - Hygienic protection element as in Claim 1, characterized in that said film (11) is temporally associated with a plurality of other, identical films (11) so as to define a roll (24) .

28 - Hygienic protection element as in Claim 26 or 27, characterized in that each of said films (11) can be individually separated from the others along at least a line of preferential breakage 23.

29 - Hygienic protection element as in Claim 1, characterized in that it is able to be packaged in individual sterile packages.