AU2018217644A1

AU2018217644A1 - Self-retaining cannula with a seal of warranty

Info

Publication number: AU2018217644A1
Application number: AU2018217644A
Authority: AU
Inventors: Stefano MASTRANTONIO
Original assignee: Individual
Current assignee: Individual
Priority date: 2017-02-07
Filing date: 2018-02-05
Publication date: 2019-08-29
Also published as: WO2018146049A1; EP3579898A1; MC200184B1

Abstract

The invention relates to a disposable cannula designed to be fitted to a colonic lavage device, comprising a first component (1) and a removable cap (14), characterised in that it includes a second component (2) comprising the removable cap (14) which has a seal of warranty (15) designed to prevent the re-use of the cannula after having been moved. The invention relates to the field of colonic lavage.

Description

SELF-RETAINING CANNULA WITH SEAL OF WARRANTY

Technical field

The present invention relates to a single-use cannula for colonic lavage. The invention is configured to fit to a device intended for colonic lavage. The present invention consists in particular of a single-use cannula, intended to be used by any professional medical device for colonic lavage, hereinafter referred to as “self-retaining cannula with seal of warranty”, characterised by the fact that, by virtue of a removal cap provided with a seal of warranty, it prevents reuse of the cannula itself and, advantageously by virtue of its external form with a groove, once inserted, it remains in its optimum position, without the need for any action by a therapist or aid from an assistant or other accessories.

Prior art

Currently, the single-use cannula used by the present devices for colonic lavage is composed of two components, the cannula and the removable cap ofthe cannula. Schematically, the cannula is composed of a tube made from rigid plastics material, composed, from the functional point of view, of an insertable part, in the form of a truncated cone, and a non-insertable part with a side entry for the lavage water that enters, and a pipe, with a constant diameter, positioned at the rear ofthe cannula, for discharge of the lavage water. The removable cap is composed of a small cap with a cone shape, positioned, with pressure, on the front face of the insertable part of the cannula, and a plate with a circular hole positioned at the rear of the cannula, connected together by a stem.

When the small conical cap is inserted inside the insertable part of the cannula, the conical-shaped cap is positioned, with pressure, on the front end of the cannula, while the plate with the hole is situated at the rear thereof and the two components form a single body.

The function of the small conical cap is to assist the introduction of the cannula and is removed, by the therapist (who may be referred to as the hydrotherapist), after introduction thereof at the start of the therapy by means of the plate with the hole.

After having removed the removable cap, a flexible tube, for eliminating the discharged lavage water, is inserted with pressure, by the therapist, on the pipe present at the rear of the cannula.

The internal section of the cannula acts as a pipe for discharge of the lavage water.

The aforementioned cannula, however, has limits. The slightly conical shape of the cannula, with a smooth surface lubricated during the therapy, combined with the

WO 2018/146049

PCT/EP2018/052813 involuntary contractions of the muscles involved, results in a thrust applied to the cannula, which therefore has a tendency to retract.

This phenomenon is further aggravated by the movements that the patient must inevitably make on the bed, during the treatment, and, partly, by the force of gravity.

The above is confirmed by the fact that, in order to remedy this drawback, a tongue made from plastics material is present on the traditional cannula, for the specific purpose of providing a support to a single-use belt made from plastics material, especially designed to prevent retraction.

The only alternative is a continuous visual check on the cannula and constant action by the therapist or an assistant during the treatment.

The limits of the two countermeasures, however, are obvious and insurmountable.

In the first case, the belt in question cannot guarantee a complete grip and moves during the movements of the patients, so that many centres that practice colonic lavage do not use it.

In the second case, the therapist or assistant must exercise a checking function in addition and, if necessary, must reposition the cannula, which causes a certain amount of discomfort for the patient.

Furthermore, the removable pressure cap could theoretically be reused several times, to the detriment of hygiene and safety of the patient.

On the market, there are also cannulas that have a bulge in the initial part, but the insertion thereof is more traumatic for the muscles involved. Furthermore, the part of the cannula that remains inserted is shorter compared with the cannula that is the subject matter of the present invention.

Disclosure of the invention

The aim of the innovations that constitute the subject matter of the present invention is to improve mainly the safety of the patient and, secondly, the comfort of the patient and of the therapist, during the treatment, by eliminating the aforementioned drawbacks by means respectively of a different type of removable cap and/or an innovative external shape of the cannula.

To this end, the present invention relates in particular to a single-use cannula configured to fit to a device intended for colonic lavage, comprising a first component and a removable cap characterised in that it comprises a second component comprising a removable cap that comprises a seal of guarantee configured to prevent reuse of the cannula after displacement.

WO 2018/146049

PCT/EP2018/052813

The presence of the seal of guarantee ensures single use of the cannula and therefore increased safety and hygiene for the patient.

With regard to comfort, the novel external form of the cannula has a groove by means of which, once inserted, the cannula remains in its optimum position without action by the therapist or the help of other accessories.

According to another separable and non-limitative aspect, the fundamental principle of the invention consists of a sealed single-use cannula for any medical device for colonic lavage, the purpose of which is to prevent reuse of the cannula, with total guarantee of hygiene for the patient, and, among other things, improving the functionality of the cannula and comfort for the patient and also of the therapist during treatment.

To this end, the component of the cannula that must be removed during treatment is provided with a removable cap equipped with a seal of warranty.

After the detachment of the seal of warranty, that is to say after the first use of the cannula, the aforementioned component does not remain in place, that is to say it is no longer held under pressure, and reuse of the cannula becomes impossible and even dangerous.

The component that is used during the treatment, that is to say the cannula or first component, preferably has an external form with a groove that enables the cannula to remain in its optimum position without the need for any action by the therapist or other accessories.

This is because the involuntary reflex of the sphincter muscle to contract finds in the groove a comfortable housing, which therefore has a tendency to hold the cannula in position.

Fundamentally the novel cannula keeps the typical form of a truncated cone, but with a cone a little more accentuated towards the rear.

Once past the point with the largest diameter, there is a slight narrowing (a groove); continuing towards the rear, the groove is connected by a short portion of constant diameter, equal to the maximum diameter present in the insertable part of the cannula. This line is traversed by the tube for entry of the lavage water and, on the external surface, laterally, there are ribs in relief that considerably increase the grip of the fingers of the therapist. The first part of this portion coincides with the limit of the insertable part of the cannula.

At the end of this section, the diameter of the non-insertable part of the cannula decreases to allow the insertion, with pressure, of the flexible tube for discharging the lavage water.

On this same portion, an anchoring ring has been inserted, with a special form for fixing the removable cap equipped this time with a seal of warranty.

The groove is specially formed to accept the muscles involved, and profits from the often involuntary grip of the latter, which contract and grip the cannula at the groove, therefore keeping its optimum position, which prevents retraction.

WO 2018/146049

PCT/EP2018/052813

Even the novel small conical cap has been considerably modified to prevent reuse of the single-use cannula.

To this end, the maximum diameter of the cone has been reduced just enough for the conical cap no longer to be under pressure. The part at the rear of the traditional removable cap has been replaced by a novel removable cap provided, this time, with a seal of warranty which, once torn, after first use, no longer enables the small conical cap to remain inserted in the cannula during introduction.

Independently another aspect of the invention relates to a single-use cannula applicable to any professional device for colonic lavage, hereinafter referred to as “selfretaining cannula with seal of warranty”, and the size of which can vary in steps according to individual requirements, characterised by the fact that, by virtue of its external form, given by way of non-limitative example, and, in particular, the presence of a groove positioned at the end of the insertable part of the cannula, once inserted, it maintains its position, profiting from the involuntary grip that the muscles involved exert in correspondence with the groove itself.

Independently, another aspect of the invention relates to a cannula the component of which is provided with a removable cap with a seal of warranty, applicable, itself, to any type of cannula for colonic lavage, which prevents reuse of the cannula after first displacement thereof, the whole as described and illustrated in the accompanying drawings.

Brief description of the figures

These features and others of the invention will be obvious from the following description of a preferred embodiment, given by way of non-limitative example, referring to the accompanying drawings, in which:

Fig. 1 shows the already assembled whole of the self-retaining cannula with seal of warranty composed of the components 1 and 2 before use thereof. Figure 1A illustrates a perspective view of the cannula composed of the first component 1 and the second component 2 assembled together. Figure 1B illustrates a side view thereof.

Fig. 2 shows an exploded view of the self-retaining cannula with seal of warranty that shows the two components 1 and 2, separated from one another, before assembly and packaging. Fig. 3 shows the component 1 with the indication of the main parts thereof. Figure 3A illustrates a perspective view of the first component 1. Figure 3B illustrates a side view thereof.

Fig. 4 shows the component 2 with the indication of its main parts before assembly and packaging. Figure 4A illustrates a perspective view of the second component 2. Figure 4B illustrates a side view thereof.

Detailed disclosure of particular embodiments

WO 2018/146049

PCT/EP2018/052813

Before beginning a detailed review of embodiments of the invention, optional features, which may optionally be used in association or alternatively, are stated hereinafter.

It is stated first of all that the invention relates to a single-use cannula configured to fit to a device intended for colonic lavage, comprising a first component 1 and a removable cap 14, characterised in that it comprises a second component 2 comprising the removable cap that comprises a seal of warranty 15 configured to prevent reuse of the cannula after withdrawal.

Advantageously, according to preferred but non-limitative variants, the invention is such that:

- the cannula comprises an anchoring ring 5 disposed on the first component 1, intended to fix the removable cap 14 while cooperating with the seal of warranty;

- the seal of warranty 15 is heat-sealed to the second component (2);

- the second component 2 consists of the removable cap 14, a conically shaped cap 12 (and preferably small) intended to facilitate the insertion of the cannula, and a stem 13 connecting the small cap 12 to the removable cap 14;

- the first component 1 is composed of a tube made from rigid plastics material, composed in its turn of an insertable part, in the form of a truncated cone, and a non-insertable part with a side entry for lavage water 6 that enters, and a pipe 7, positioned at the rear of the cannula, for discharge of the lavage water;

- the conically shaped insertable part of the first component 1 is intended to cooperate with the conically shaped cap 12 so that the largest diameter of the conically shaped cap 12 coincides with the diameter of a front internal section of the first component 1;

- the first component comprises a groove positioned at the end of an insertable part configured to receive muscles involved.

According to another aspect, the invention relates to a method for assembling a cannula according to any of the preceding claims, comprising the insertion of the second component 2 inside the first component 1 until the warranty ring 15 passes beyond the anchoring ring 5 present on the first component 1 and advantageously engages firmly.

As illustrated in Figs. 1,2, 3 and 4, the device according to the invention is composed solely of two components. The component 1, Fig. 2, or first component 1 (also being able to be referred to as the cannula), is the core of the system since, by itself, it improves the functionality of the cannula, by preventing withdrawal, by virtue of the groove 4, Fig. 3 and, conjointly with the component 2, Fig. 2, or second component 2, helps to prevent reuse thereof by virtue of the adoption of the seal of warranty 15, Fig. 4.

WO 2018/146049

PCT/EP2018/052813

The conical form of the small front cap 12, Fig. 4, and the conical form of the insertable part of the cannula assist the insertion and gradual adaptation of the muscles to the foreign body.

Just after the point with the largest diameter 9 Fig. 3, present in the insertable part of the cannula, the muscles involved find the groove 4, Fig. 3, inside which they fit naturally.

The involuntary reflex of the sphincter muscle to contract finds in the groove 4, Fig. 3, the most comfortable housing for it, which it therefore has a tendency to keep.

The following portion 8, Fig. 3, with a larger and constant diameter, has the incoming lavage water supply pipe 6 passing through it, Fig. 3, and has rounded edges, and the initial part thereof is the limit of the insertable part of the cannula 1, Fig.

2.

In addition, it also fulfils the function of handle for the therapist, since it is equipped with ribs in lateral relief 11, Fig. 3, very useful for insertion of the cannula 1, Fig. 2, and for extraction of the component 2, Fig. 2.

The entry for the lavage water 6, Fig. 3, and the outlet for the lavage water 7, Fig. 3, keep the same position, angle, diameter and internal cross section of the majority of traditional cannulas. This avoids additional adjustments and settings on the machine.

The component 2, Fig. 2, consists of a small conically shaped cap 12, Fig. 4, at the front, which facilitates the insertion of the cannula 1, Fig. 2; this is connected, by means of a stem 13, Fig. 4, to the removable cap 14, Fig. 4, with the seal of warranty 15, Fig. 4.

During assembly, the small conical cap 12, Fig. 4, and the stem 13, Fig. 4, are inserted inside the cannula 1, Fig. 2; the cap 14, Fig. 4, with the seal of warranty 15, Fig. 4, is rather placed onto the end part 7, Fig. 3, of the cannula 1, Fig. 2, until the seal of warranty 15, Fig. 4, goes beyond the anchoring ring 5, Fig. 3, present in the component 1, Fig. 2.

In practice, the component 2, Fig. 2, has two important changes with respect to the traditional cannula; the first modification relates to the diameter of the small conical cap 12, Fig. 4, which has been reduced and coincides with the diameter of the front internal section of the cannula 1, Fig. 2.

This means that, once inserted, it will not be able, alone, to maintain its position; because, after the reduction of its diameter, it is no longer a pressure cap, as in the traditional cannula.

The possibility of remaining in its position during insertion is given by the second modification, which consists of adding, to the component 2, Fig. 2, a cap 14, Fig. 4, with a seal of guarantee 15, Fig. 4.

WO 2018/146049

PCT/EP2018/052813

The seal of guarantee 15, Fig. 4, heat-sealed to the component 2, Fig. 2, once inserted on the cannula 1, Fig. 2, in the assembly phase, is connected thereto.

After insertion of the cannula 1, Fig. 2, the rotation of the cap 14, Fig. 4, through a few degrees, breaks the heat-sealed bonds connecting together the components 1 and 2, Fig. 2, because of the traction exerted by the rotation. In fact, whereas the component 2, Fig. 2, can turn on its longitudinal axis, the seal of warranty 15, Fig. 4, cannot do this because of the teeth that are wedged in the corresponding slots 10, Fig. 3, present on the anchoring ring 5, Fig. 3, of the cannula 1, Fig. 2.

The heat-sealed connections are designed so as to tear, leaving no waste, when they are subjected to a lateral traction. In this case, the connections give way as soon as the component 2, Fig. 2, begins its rotation.

The lateral traction necessary for the detachment of the bonds is effected by gently turning the plug 14, Fig. 4, gently in the clockwise or anticlockwise direction, while the cannula 1, Fig. 2, cannot turn since it is held in position by the fingers of the therapist gripping the handle 8, Fig. 3. Advantageously, the removable cap 14 comprises a manipulation zone 16 advantageously comprising reliefs of the rib type facilitating gripping and actuation of the removable cap 14.

After detachment, the seal of warranty 15, Fig. 4, will remain in its seat, present on the front part of the anchoring ring 5, Fig. 3, of the cannula 1, Fig. 2, while the component 2, Fig. 2, comprising the small cap 12, Fig. 4, the cap 14, Fig. 4, and the stem 13, Fig. 4, will be extracted and eliminated.

After the first use, it is impossible to re-weld the connections. The component 2, Fig. 2, does not remain in place and inserting the cannula 1, Fig. 2, becomes impossible and even dangerous.

Referring, solely by way of a non-limitative example, to Fig. 2, this shows an exploded view of the cannula 1. The components 1 and 2 must be manufactured by moulding with the particular type of thermoplastic materials for food use.

At the time of assembly, the component 2 is inserted inside the component 1 until the warranty ring 15, Fig. 4, goes beyond the anchoring ring 5, Fig. 3, present on the component 1, Fig. 2.

Particular attention should be given to the determination of the diameter of the front internal section of the cannula 1, Fig. 2, and the maximum external diameter of the small conical cap 12, Fig. 4, which must correspond while avoiding making a pressure cap.

The single-use cannula according to the invention comprises two components:

the first component 1 and the second component 2. The first component 1 illustrated in figures 1 and 3 has an insertable part and a non-insertable part. It may comprise a hollow body, preferably symmetrical along a longitudinal axis corresponding to an insertion direction.

WO 2018/146049

PCT/EP2018/052813

The insertable part has the general form of a truncated cone. The insertable part extends from the distal end as far as the proximal end of a groove 4. The non-insertable part extends from the proximal end as far as the proximal end of the groove 4.

The distal end corresponds to the end furthest away from the hydrotherapist and the proximal end corresponds to the end closest to the hydrotherapist. The distal end corresponds to the truncated end of the cone.

The insertable part has its diameter increased between the distal end and a maximum diameter 9. After the point with the largest diameter 9, the first component 1 comprises a narrowing forming a groove 4. After the groove 4, the first component 1 comprises the non-insertable part. The non-insertable part comprises a preferentially short portion 8 with a constant diameter advantageously equal to the largest diameter 9 of the insertable part. This portion 8 has a lavage water entry pipe 6 passing through it. This portion 8 advantageously comprises a manipulation zone preferentially provided with reliefs of the rib type 11. This portion 8 is connected to a zone corresponding to a lavage water outlet pipe 7. The diameter of this zone is less than the diameter of the portion 8 in order to allow the insertion of a lavage water discharge tube. An anchoring ring 5 is positioned on the first component preferentially at the zone 7. This zone 7 is configured to cooperate with the removable cap 14.

\N0 2018/146049

PCT/EP2018/052813

REFERENCES

1. First component

2. Second component

3. Groove

4. Anchoring ring

5. Incoming lavage water feed pipe

6. Lavage water outlet

7. Handle or following portion

8. Large diameter

9. Slots

10. Lateral reliefs

11. Small cap (conical cap)

12. Stem

13. Removable cap

14. Seal of warranty

15. Manipulation zone

WO 2018/146049

PCT/EP2018/052813

1. Single-use cannula configured to fit to a device intended for colonic lavage, comprising a first component (1) and a removable cap (14), characterised in that it comprises a second component (2) comprising the removable cap (14) that comprises a seal of warranty (15) configured to prevent re-use of the cannula after withdrawal.

Claims

2. Cannula according to the preceding claim, comprising an anchoring ring (5) disposed on the first component (1) and intended to fix the removable cap (14) while cooperating with the seal of warranty (15).
3. Cannula according to either of the preceding claims, wherein the seal of warranty (15) is heat sealed to the second component (2),
4. Cannula according to any of the preceding claims, wherein the second component (2) consists of a removable cap (14), a conical shaped cap (12) intended to facilitate insertion of the cannula and a stem (13) connecting the conical shaped cap (12) to the removable cap (14).
5. Cannula according to any of the preceding claims, wherein the first component (1) is composed of a tube made from rigid plastics material, composed in its turn of an insertable part, in the form of a truncated cone, and a non-insertable part with a lateral entry for the lavage water (6) that enters, and a pipe (7) positioned at the rear of the cannula for discharge of the lavage water.
6. Cannula according to the preceding claim in combination with claim 4, wherein the insertable part of the first component (1) is intended to cooperate with the conical shaped cap (12) so that the largest diameter of the conical shaped cap (12) coincides with the diameter of a front internal section of the first component (1).
7. Cannula according to any of the preceding claims, wherein the first component comprises a groove positioned at the end of an insertable part configured to receive involved muscles.

\N0 2018/146049

PCT/EP2018/052813
8. Method for assembling a cannula according to any of the preceding claims, comprising the insertion of the second component (2) inside the first component (1) until the seal of warranty (15) passes beyond the anchoring ring (5) present on the first component (1).