WO2002089896A1

WO2002089896A1 - Device for retaining a drainage tube

Info

Publication number: WO2002089896A1
Application number: PCT/IT2002/000309
Authority: WO
Inventors: Lorenzo Mantovani; Paolo Vielmo
Original assignee: Lar S.P.A.
Priority date: 2001-05-10
Filing date: 2002-05-09
Publication date: 2002-11-14

Abstract

A device (17) for retaining a drainage tube (T), comprising a tube-engaging portion (19), apt to assume a retaining configuration wherein it engages an outer wall of the drainage tube, and a releasing configuration wherein the tube is mobile with respect thereof, and a fastening portion (171, 172) to fasten the device to the patient's skin, placed sideways to the retaining portion.

Description

DEVICE FOR RETAINING A DRAINAGE TUBE

DESCRIPTION

The present invention relates to a device for retaining a drainage tube and to a kit related thereto. Many surgical treatments require the introduction in the patient's body, and in paiticular in a bodily cavity or in a wound, of a drainage tube allowing a defluxion of liquid and/or aeriform biological fluids outwards the body itself.

Figure 1 shows indeed a perspective schematic view of a drainage tube T inserted in a patient's body at a suture S. A skilled in the art will understand that the representation of the arrangement of the tube T in such figure and in the following figures is purely an example, since the tube T may also be inserted in the subject's body sideways with respect to the main suture instead of directly through the latter.

To carry out its function effectively, the tube T must be locked in a wished position, so that it cannot move with respect to the patient's body, h particular, it absolutely must not slide along its own longitudinal axis, that is through the suture.

As shown in the above-mentioned figure 1, such locking is typically performed by means of a mesh F of surgical thread. The latter on one side is stitched on the patient's skin and on the opposite side it is fixed to a ring E placed around the tube T, ring which may be also implemented with the same or with another surgical thread. The just described locking modes of the drainage tube have some important drawbacks.

The main drawback is that they do not guarantee a firm and reliable anchorage of the tube to the patient's body, and in particular to the skin. In particular, neither the suture on the skin of the surgical thread for retaining the tube nor the above-said combination mesh-ring are suitable to avoid shifts of the tube with respect to the patient's body due to movements, even slight, of the latter.

Furthermore, the above-said stitching of the retaining thread on the patient's body may be troublesome and/or painful for the patient himself/herself. To this purpose, it is a common notion that exactly said skin stitchings could be the cause of widespread physical sufferings .

The technical problem underlying the present invention is to provide a device for retaining a drainage tube and a kit related thereto enabling to obviate to the drawbacks mentioned above with reference to the known art.

Such problem is overcome by a device for retaining a drainage tube according to claim 1. According to the same inventive concept, the present invention also relates to a kit for retaining a drainage tube according to claim 22.

The present invention provides some important advantages. The main advantage is that the device of the invention guarantees a firm and reliable retaining of the drainage tube, without causing troubles to the patient.

Other advantages, features and application modes of the present invention will be evident from the following detailed description of some embodiments, illustrated by way of example and not for limitative purposes. The figures of the enclosed drawings will be referred to, wherein: figure 1 has been already introduced with reference to the known art; figure 2 A shows a perspective view of a first embodiment of the device for retaining a drainage tube according to the present invention, in a retaining configuration of the tube itself; figure 2B shows a front view of the device of figure 2A with the drainage tube partially in section, in a releasing configuration of the latter; figure 3 A shows a perspective view of a second embodiment of the retaining device according to the present invention, in a retaining configuration of the drainage tube; figure 3B shows a front view of the device of figure 3A with the drainage tube partially in section, in a releasing configuration of the latter; figure 4 shows a front view of a third embodiment of the retaining device according to the present invention, in a releasing configuration of the drainage tube; figure 5 shows a front view of a fourth embodiment of the retaining device according to the present invention in a retaining configuration of the drainage tube; figure 6 shows a perspective view of a fifth embodiment of the retaining device according to the present invention, in a retaining configuration of the drainage tube; figure 7 shows a perspective view of a sixth embodiment of the retaining device according to the present invention, in a retaining configuration of the drainage tube; figure 8 A shows a perspective view of a seventh embodiment of the retaining device according to the present invention, in a releasing configuration of the drainage tube; figure 8B shows a perspective view of the device of figure 8 A, in a retaining configuration of the drainage tube; figure 9A shows a perspective view of the device of figure 8A upon use, in a releasing configuration of the drainage tube; figure 9B shows a perspective view of the device of figure 8A upon use, in a retaming configuration of the drainage tube; and figure 10 shows a plan view of the device of figure 8 A upon use, in a retaining configuration of the drainage tube.

By firstly referring to figure 2A, a device for retaining a drainage tube T according a first embodiment of the invention is designated as a whole with 1.

The device 1 comprises an engaging portion 2, apt to engage the drainage tube T to hold it, and side portions 3 apt to be fastened on a patient's skin, originating from the engaging portion 2. hi the present embodiment, the device 1 substantially consists in a filiform shaped member made of an elastically deformable material, for example a plastic or metallic material. The device is then implemented in one single piece.

Still in the present embodiment and by also referring to figure 2B, the engaging portion 2 has a sinuous shape, and in particular it comprises a central loop 21 apt to engage the drainage tube T, as it will be illustrated later in greater detail, by referring to the using modes of the device 1.

The device 1 also comprises two arm members implementing the above-mentioned fastening portions to the patient's skin and which are designated too with 3. The arm members 3 extend sideways to the engaging portion 2, substantially on opposite sides with respect thereto. Each of them has an enlarged end portion 31, represented in outline in figure 2A, apt to adhere to the patient's body to allow locking the device 1 on the latter. hi the present embodiment, the end portions 31 are implemented by closing as a ring the component filiform member, i general, they may assume any shape apt to guarantee a broad contact surface with the patient's skin, so as to improve locking the device 1 on the patient's body.

As shown in figure 2A, there is a difference in level between the end portions 31 and the engaging portion 2. hi particular, the arm members 3 have a first segment inclined with respect to the engaging portion 2, so that the latter lies on a plane substantially different with respect to the one of the end portions 31.

The using modes of the device 1 will be now illustrated by still referring to figures 2A and 2B.

By firstly referring to figure 2A, the device 1 is applied to hold the drainage tube T in the wished position, once part of the latter has been introduced in the patient's body and a suture S of the corresponding surgical incision has been performed. In particular, as shown in figure 2B, by acting on the arm members 3 in the direction shown by the arrows the engaging portion 2 of the device 1 may be elastically deformed so that it can assume an open releasing configuration, hi such configuration, the inner port defined by the loop 21 broadens so as to allow the tube T sliding inside thereof. The device 1 can be so inserted on the part of tube T outside the body, until the end portions 31 of the arm members 3 abut on the body itself. At this point, the arm members 3 are released, so that the engaging portion 2 assumes a retaining configuration wherein the loop 21 is closed around the outer wall of the tube T to retain it. The end portions 31 are then locked on the patient's skin by means of adhesive gauzes 4 or equivalent fastening means.

Of course, to extract the tube T it is sufficient to perform the operations so far described in the opposite order.

The difference in level existing between the engaging portion 2 and the arms 3 provides some important advantages. First of all, this makes it that the engaging portion 2 does not come in contact with the patient's skin and therefore that it does not cause any trouble to the latter. Furthermore, such difference in level, together with the elasticity of the material with which the device 1 is made, allows to slightly force the end portions 31 against the patient's body and to lock them in this forced condition by means of gauzes 4. This evidently further improves the retaining of the tube T.

Figures 3 A to 10 relate to additional embodiments of the mvention, which will be described only by referring to the factors differentiating them one from the other and from the first embodiment so far illustrated. Therefore, analogous components will be designated with the same reference numeral already used.

By referring to figures 3A and 3B, based upon a second embodiment a retaining device according to the invention, hi this case designated with 5, comprises a substantially annular-shaped engaging portion 6, to lock a drainage tube T inside thereof.

The device 5 then comprises two arm members 7 integral with the engaging portion 6 and substantially analogous to the ones already described by referring to the first embodiment. Also in this second embodiment the device of the mvention is obtained starting from an elastically deformable filiforai member, hi particular, also in this case the above- mentioned arm members 7 are actuatable to produce an elastic deformation of the engaging portion 6, as shown by the arrows of figure 3B.

With respect to the first embodiment, the annular shape of the engaging portion 6, obtained by wrapping the component filiform member on itself, guarantees a broader contact surface with the tube T and it then improves retaining thereof.

Figure 4 relates to a third embodiment of the device of the invention, in this case designated with 8. The device 8 comprises an engaging portion 6 substantially analogous to the one of the second embodiment, and two arm members 9 to fasten the device itself to the patient's skin having instead a different arrangement and shape with respect to the previous embodiments. hi particular, the arm members 9 originate sideways to the engaging portion 6, and, when the device 8 is in a retaining configuration, they are placed according to a relative angle equal to about 90 degrees.

As the preceding cases, in figure 4 the actuation direction and versus of the arms 9 to enable the release of the tube T are shown by arrows.

Furthermore, such arm members 9 have each a curved end portion 91, apt to be locked by means of one or more plasters or adhesive gauzes on the patient's body. Moreover, both arm members 9 of the present embodiment have a smaller extension with respect to those of the preceding embodiments. Thanks to this, the device 8 is particularly apt to the case wherein the drainage tube is to be applied at bodily districts difficult to be reached and wherein a device with bigger sizes could be troublesome for the patient and difficult to be applied by the operator performing the operation.

Figure 5 then relates to a fourth embodiment of the device of the invention, in this case designated with 10. The device 10 is very similar to the one of the third embodiment above described, in particular having an annular-shaped engaging portion 6 and two arm members 11 of reduced size. Unlike those of the third embodiment, such arm members 11 have a substantially rectilinear development, which simplifies the manufacturing of the device 10.

Figure 6 relates to a fifth embodiment of the invention, wherein a device 12 is implemented, as in the preceding embodiments, in a single piece by means of an elastically deformable filiform member.

The device 12 comprises an engaging portion 13 obtained by winding substantially like a helix the filiform member. Such helicoidal shape further improves retaining the tube T, as well as the elastic deformability of the whole structure. The device 12 then comprises two arm members 7 substantially analogous to those already described with reference to the second embodiment.

Figure 7 shows a sixth embodiment of the invention. hi this case, a device 14 for retaining a drainage tube T is implemented starting from a single piece of elastically deformable material.

The device 14 comprises a central engaging portion 15, having a hole apt to allow the passage of the tube T therethrough.

The device 14 further comprises two arm members 16 for fastening to the patient's body, placed sideways to the engaging portion 15, substantially on opposite sides with respect thereto. Such arm members 16 have each an end plate 161, with substantially rectangular shape front viewed and apt to adhere to the patient's skin. Such plates 161 are apt to be locked to the patient's skin by means of an adhesive gauze 4, as shown in Figure 7, or by means of an adhesive, for example a gel, applied on their face apt to go in contact with the skin. The portion of each arm 16 adjacent to the central portion 15 has an inclination, so that, as for the preceding embodiments, the plates 161 and the portion 15 lie on substantially different levels.

Even in this case, the passage from a tube-retaining configuration to a configuration releasing thereof is performed by acting on the arm members 16. In particular, by exerting a forced action on the latter it is possible to deform the walls of the hole made on the central portion 15 so that the tube T can slide with respect thereto.

At this point it will be understood that embodiment variants of the invention may provide that the device comprises any number of fastening arms.

Furthermore, another embodiment variant of the invention with respect to those here illustrated provides that the passage from a tube-retaining configuration to a releasing configuration, and viceversa, be entrusted, rather than to the elastic deformability of the device itself, to an opening/closing mechanism of the engaging portion, for example an automatic release mechanism of conventional type.

By now referring to the figures 8 A to 10, a retaining device of a seventh embodiment is designated as a whole with 17.

As shown in figure 8 A, the device 17 is implemented in two parts, in particular in a first part 171 and a second part 172, substantially flat and with substantially rectangular shape plan viewed. The two parts 171 and 172 are placed side by side and so as to be substantially coplanar. Such parts 171 and 172 are further rotatably connected the one to the other at their own respective faced ends by means of an elastic member, and in particular an elastic lamina 18.

Thanks to the above-mentioned connection, the two parts 171 and 172 are rotatable the one with respect to the other around an axis substantially orthogonal to their prevalent development plane. Therefore, the two parts 171 and 172 may be mutually divaricated in a releasing configuration of a tube, shown in the figures 8A and 9A, and mutually brought nearer in a retaining configuration of a tube, shown in the figures 8B, 9B and 10.

Moreover, the two parts 171 and 172 have, at respective faced side edges, respective complementary shaped profiles 173, each having a plurality of recesses with different depth. The arrangement of the latter is such that each recess of the first part 171 is faced on a respective recess of the second part 172 substantially equal to the first recess, so that such pair of faced recesses defines, in said retaining configuration, a retaining seat 19 for a drainage tube. In the present embodiment, a plurality of seats 19, each apt to receive and hold a drainage tube with a predetermined diameter, corresponds to the above-mentioned plurality of recesses. Still in the present embodiment, the seats 19 are substantially cross-shaped, having protrusions 191 apt to engage on the side wall of the drainage tube. Embodiment variants may of course provide any shape for the retaining seats, and in particular a substantially circular profile.

The device 17 further comprises locking means 20 to lock the two parts 171 and 172 in the retaining configuration, hi the present embodiment, such means consists in particular in a reversible-hooking mechanism, designated too with 20, of the second part 172 to the first part 171. The latter comprises a tongue 200, integral with the second part 172 and placed at the end thereof opposite to the end having the elastic lamina 18, and a corresponding hook tooth 201, integral with the first part 171 and apt to insert itself in an opening 202 of the tongue 200 when the two parts 171 and 172 are brought nearer in the retaining configuration.

As a whole, then, the device 17 has a pincers-like structure, wherein the two parts 171 and 172 represent members which may be clamped the one against the other implementing, in their central portion having the seats 19, a retaining portion of the drainage tube.

The locking modes of a retaining tube by means of the device 17 will be clear at this point, and the figures 9A, 9B and 10 relate thereto.

By referring to these last figures, once a part of the drainage tube T has been introduced in the patient's body and a suture S of the corresponding surgical incision has been performed, the device 17 is brought in open releasing configuration and placed around the tube so that the latter is positioned at a pair of recesses apt to define a seat 19 with sizes appropriate for the tube itself. Then, the device 17 is made to slide until abutting on the patient's skin and, in such position, brought in retaining configuration by rotating the two parts 171 and 172 one towards the other. The latter are then locked in such configuration by the means 20.

Obviously, for releasing the drainage tube T it is sufficient to perform the operations so far described in the opposite order.

As far as the fastening of the device 17 itself to the patient's body is concerned, this is allowed by the flat shape and by the extension of the side portions of the two parts

171 and 172, which are then apt to be adhered on the skin. Such fastening side portions are locked on the patient's skin by means of adhesive gauzes, gel plasters or equivalent means, which for clarity have not been shown in the figures.

It will be then appreciated that the substantially flat structure of the device of the seventh embodiment here described allows it to be firmly rested in adherence to the patient's skin.

It will be fuither appreciated that the above-mentioned plurality of seats defined by the device of the invention makes the latter extremely versatile. This is particularly advantageous since the drainage tubes, generally being manufactured with more or less soft polymeric material, have diameters with broad tolerance.

Furthermore, a simplified embodiment variant provides that the retaining seats have all equal sizes, to provide a plurality of position possibilities of the device with respect to the drainage tube.

Embodiment variants provide of course a different implementation both of the locking means and of the rotating connection between the two parts of the device.

The latter, for example, may be implemented by means of a pin member of conventional type.

Furthermore, locking means equivalent to the tongue-like ones here introduced may exist also in the embodiments from the first to the sixth one above described, to lock the respective engaging portions in the retaining configuration. It will be also understood that the invention provides additional embodiments wherein the different features of the various embodiments so far illustrated are combined. For example, a difference in level between the engaging portion and the fastening side portions may be provided also in the seventh embodiment above illustrated, similarly to the first embodiment above described.

At this point it will be appreciated that, in all embodiments here illustrated, the device of the invention is of very easy and cheap construction.

The device can also be used in a very comfortable and easy way and the operation thereof is safe and reliable, hi particular, it concretely and positively allows reducing passive times, to whole advantage of the quick and safe intervention of the medical operator.

Furthermore, the device may be manufactured with only one recyclable polymeric material or with several polymeric materials compatible among them and recyclable.

The present invention also provides a kit for retaining a drainage tube, comprising a retaining device according to the invention, and fastening means of such device with respect to the patient's body, such as for example a gauze or an adhesive plaster or an adhesive tube in gel.

The present invention has been so far described by referring to preferred embodiments. It is to be meant that other embodiments underlying the same inventive concept can exist, all however comprised within the protective scope of the herebelow reported claims.

Claims

CLAΓMS

I. A device (1; 5; 8; 10; 12; 14; 17) for retaining a drainage tube (T), characterized in that it comprises: a tube-engaging portion (2; 6; 13; 15), apt to assume a retaining configuration, wherein it engages an outer wall of the drainage tube, and a releasing configuration, wherein the tube is movable with respect thereto; and a fastening portion (3; 9; 7;11; 16) apt to be fastened on a patient's skin, arranged sideways to said retaining portion. 2. The device (1; 5; 8; 10; 12; 14) according to claim 1, wherein a difference in level is provided between said engaging portion (2; 6; 13; 15) and said fastening portion (3; 7; 9; 11; 16). 3. The device (1; 5; 8; 10; 12; 14; 17) according to claim 1 or 2, wherein said engaging portion (2; 6; 13; 15; 19) is made of an elastically deformable material. 4. The device (1; 5; 8; 10; 12; 14) according to any of the preceding claims, wherein said fastening portion comprises a plurality of arm members (3; 7; 9; 11; 16) placed sideways to said engaging portion (2; 6; 13; 15).

5. The device (1; 5; 8; 10; 12; 14) according to claims 3 and 4, wherein said arm members (3; 7; 9; 11; 16) are actuatable to produce an elastic deformation of said engaging portion (2; 6; 13; 15).

6. The device (1; 5; 8; 10; 12; 14) according to claim 4 or 5, wherein each of said ami members (3; 7; 9; 11; 16) has an enlarged end portion (31; 91; 161) apt to adhere to the patient's skin.

7. The device (5; 8; 10; 12; 14) according to any of the preceding claims, wherein said engaging portion (6; 13; 15) has a substantially annular shape, to lock inside thereof, in said retaining configuration, the drainage tube (T).

8. The device (12) according to the preceding claim, wherein said engaging portion (13) comprises a substantially helicoidal structure.

9. The device (1) according to any of the claims 1 to 6, wherein said engaging portion (2) has a sinuous shape, comprising a central loop (21) apt to retain into engagement the drainage tube (T).

10. The device (1; 5; 8; 10; 12) according to any of the preceding claims, implemented by means of a shaped filiform member.

II. The device (17) according to any of the claims 1 to 3, wherein said engaging portion has at least a retaining seat (19) apt to receive and retain a drainage tube

(T).

12. The device (17) according to the preceding claim, wherein said engaging portion has a plurality of retaining seats (19).

13. The device (17) according to the preceding claim, wherein said retaining seats (19) have sizes different the one from the other, so as to allow retaining drainage tubes (T) with different diameter.

14. The device (17) according to any of the claims 11 to 13, wherein said at least ona retaining seat (19) has a plurality of protrusions (191) apt to engage the side wall of the drainage tube (T).

15. The device (17) according to any of the claims 1 to 3 or 11 to 14, comprising two jaw members (171, 172) rotatably connected and which apt to be clamped the one against the other in said retaining configuration, and wherein said engaging portion comprises respective faced and complementary shaped profiles (173) of said jaw members apt to define, in said retaining configuration, at least a retaining seat (19) of the drainage tube (T). 16. The device (17) according to the preceding claim, wherein said rotatable connection between said jaw members (171, 172) is implemented by means of an elastic member (18).

17. The device (17) according to claim 15, wherein said rotatable connection between said jaw members (171, 172) is implemented by means of a pin member. 18. The device (17) according to any of the claims 15 to 17, wherein at least one of said jaw members (171, 172) has a substantially flat fastening portion apt to be adhered on the patient's skin, placed sideways to the respective shaped profile

(173).

19. The device (17) according to any of the preceding claims, comprising locking means (20) of said engaging portion in said retaining configuration.

20. The device (17) according to the preceding claim, wherein said locking means are reversible-hooking members (20).

21. The device (17) according to the preceding claim if dependent from any of the claims 15 to 17, wherein said locking means (20) comprises a tongue (200) fastened to one of said jaw members (172) and a corresponding tooth (201) fastened to the other one (171) of said jaw members and apt to engage an opening (202) of said tongue.

22. Kit for retaining a drainage tube (T), comprising a device (1; 5; 8; 10; 12; 14; 17) according to any of the preceding claims, and fastening means (4) on the patient's body of said fastening portion (3 ; 7; 9; 11 ; 16).