SURGICAL DRAINAGE DEVICE

Abstract

Surgical drainage device (10) comprising a first tubular body (11) inside which a second tubular body (12) is partly inserted in a telescopic and sliding manner.

Claims

1. Surgical drainage device comprising a first tubular body having a first lateral surface which has a first passage aperture, inside said first tubular body there being at least partly inserted, in a telescopic and sliding manner, a second tubular body through said first passage aperture, said second tubular body having a second lateral surface which has a second passage aperture configured to allow the fluidic communication between the inside of said first tubular body and the inside of said second tubular body, wherein said first passage aperture and said second passage aperture respectively divide said first tubular body and said second tubular body into two respective oblong portions and into said first and second terminal portions, wherein, in a first operating condition, said second terminal portion is arranged outside said first tubular body through said first passage aperture defining together with said first terminal portion an end bifurcation which confers a T-shaped conformation upon said device, and wherein, in a second operating condition, said first passage aperture is free and not engaged by said second tubular body.

2. Device as in claim 1, wherein said second tubular body is able to slide inside said first tubular body so that a respective second terminal portion of said second tubular body is able to protrude beyond said first passage aperture, selectively branching out with respect to a corresponding first terminal portion of said first tubular body.

3. Device as in claim 1, wherein said first tubular body is a distinct and separate component with respect to said second tubular body.

4. Device as in claim 1, wherein in said first operating condition said first terminal portion and said second terminal portion diverge from the axis of development of the respective tubular bodies determining a transverse bulk which is greater than the transverse bulk that said device has in said second operating condition in which said second terminal portion has a configuration aligned both with the respective second oblong portion and also with said first oblong portion.

5. Device as in claim 1, wherein in said first operating condition said first terminal portion and said second terminal portion are disposed substantially aligned and specular, and in that said second oblong portion is inserted coaxially inside said first oblong portion.

6. Device as in claim 1, wherein in said first operating condition, said second passage aperture is aligned with and opposite said first passage aperture.

7. Device as in claim 1, wherein said first passage aperture has a passage gap substantially equal to an external diameter of said second tubular body.

8. Device as in claim 1, wherein said first terminal portion and said second terminal portion have the same length, while said second oblong segment has a greater length than said first oblong segment defining, in said first condition, a gripping portion protruding with respect to said first oblong segment.

9. Device as in claim 1, wherein the external diameter of said second tubular body is slightly smaller than the internal diameter of said first tubular body, so that said second tubular body adheres to said first tubular body, yet their reciprocal sliding is guaranteed.

10. Device as in claim 1, wherein it is configured to be introduced into the common extrahepatic duct and choledochus for bile drainage.

11. Device as in claim 2, wherein said first tubular body is a distinct and separate component with respect to said second tubular body.

12. Device as in claim 11, wherein in said first operating condition said first terminal portion and said second terminal portion diverge from the axis of development of the respective tubular bodies determining a transverse bulk which is greater than the transverse bulk that said device has in said second operating condition in which said second terminal portion has a configuration aligned both with the respective second oblong portion and also with said first oblong portion.

13. Device as in claim 2, wherein in said first operating condition said first terminal portion and said second terminal portion diverge from the axis of development of the respective tubular bodies determining a transverse bulk which is greater than the transverse bulk that said device has in said second operating condition in which said second terminal portion has a configuration aligned both with the respective second oblong portion and also with said first oblong portion.

Description

ILLUSTRATION OF THE DRAWINGS

[0052] These and other aspects, features and advantages of the present invention will become clear from the following embodiment disclosure, given as a non-limiting example, with reference to the attached drawings in which:

[0053] FIG. 1 is a sectional view of a surgical drainage device in accordance with embodiments described herein and in a first operating condition;

[0054] FIG. 2 is a sectional view of the device of FIG. 1 in a second operating condition;

[0055] FIGS. 3-5 illustrate, for educational purposes, the operational phases steps for removing the device of FIG. 1 from a corpse or the body of a dummy;

[0056] FIGS. 6-8 schematically illustrate some possible applications of the device of FIGS. 1-2.

[0057] To facilitate understanding, identical reference numbers have been used, where possible, to identify identical common elements in the figures. It is to be understood that elements and features of an embodiment can be conveniently combined or incorporated into other embodiments without further clarification.

DESCRIPTION OF EMBODIMENTS

[0058] Reference will now be made in detail to the possible embodiments of the invention, one or more examples of which are shown in the attached figures by way of non-limiting example. The phraseology and terminology used herein is also for non-limiting exemplary purposes.

[0059] With reference to FIGS. 1-2, a surgical drainage device 10 is described that can be used, for example, in bile duct, resective and liver transplantation surgery for the drainage of an organic fluid, in this case of biliary fluid (FIG. 6) or abdominal fluid, or in neurosurgery to reduce intracranial pressure in case of haemorrhage (FIG. 7), or in esophageal surgery (FIG. 8) or other types of surgery.

[0060] The device 10 is configured to be introduced into the common extrahepatic duct and choledochus for bile drainage.

[0061] The device 10 comprises a first tubular body 11 having a first lateral surface 22 which has a first passage aperture 15.

[0062] Inside the first tubular body 11, a second tubular body 12 is at least partly inserted in a telescopic and sliding manner through the aforementioned first passage aperture 15.

[0063] The second tubular body 12 has a second lateral surface 23 having a second passage aperture 18 configured to allow fluidic communication between the interior of the first tubular body 11 and the interior of the second tubular body 12.

[0064] The second tubular body 12 is able to slide within the first tubular body 11 so that a respective second terminal portion 17 of the second tubular body 12 is able to protrude beyond the first passage aperture 15, selectively branching off with respect to a corresponding first terminal portion 14 of the first tubular body 11.

[0065] The first tubular body 11 is a distinct and separate component with respect to the second tubular body 12.

[0066] The device 10 is completely dismountable, that is, the second tubular body 12 can slide inside the first tubular body 11, through the first passage aperture 15, and be possibly extracted from the latter through an outlet aperture 19b of the first tubular body 11.

[0067] The first tubular body 11 and the second tubular body 12 are made of flexible and biocompatible material. The flexibility of the material is necessary both for the particular application, the surgical one, and to allow the sliding and the adaptation of the second tubular body 12 inside the first tubular body 11, as will be described in more detail below.

[0068] The telescopic and sliding insertion of the second tubular body 12 inside the first tubular body 11 allows, during the removal of the deviceafter its purpose is fulfilledto reduce or completely eliminate all the complications encountered during the removal of the traditional drainage devices. In fact, the bulk of the device 10 during removal can be reduced to the bulk of the first tubular body 11 only. This avoids causing excessive stress or traction on the structures concerned, allowing their integrity to be preserved.

[0069] The first passage aperture 15 and the second passage aperture 18 respectively divide the first tubular body 11 and the second tubular body 12 into two respective oblong portions 13, 16 and into the aforementioned first and second terminal portions 14, 17.

[0070] The first passage aperture 15 has a passage gap substantially equal to the external diameter D2 of the second tubular body 12 so as to allow its passage and sliding, but with limited clearance.

[0071] Sealing means configured to prevent organic fluid from flowing through any possible interspace between the first passage aperture 15 and the second tubular body 12 may possibly be associated with the first passage aperture 15.

[0072] The device 10 has a collection end, configured to be connected to a bag, a container or other collection device which is, in use, outside the patient's body, and an opposite reception end constituted by the aforementioned terminal portions 14, 17 which are, in use, inside the patient's body, in particular inside the space to be drained, as will be described in more detail below.

[0073] The first terminal portion 14 is made in a single body and in continuity with the first oblong portion 13. Similarly, the second terminal portion 17 is also made in a single body and in continuity with the second oblong portion 16. However, it is not excluded that the first tubular body 11 and the second tubular body 12 may consist of several components associated with each other.

[0074] The first terminal portion 14 and the second terminal portion 17 have a shorter length than the length of the respective oblong portions 13, 16. For example, the axial length of the first terminal portion 14 and the second terminal portion 17 may be between about 0.1 and about 0.15 times the linear length of the first tubular body 11 and the second tubular body 12, respectively.

[0075] The first tubular body 11 and the second tubular body 12 have a first axial channel 19 through and a second axial channel 20 through delimited by respective inlet apertures 19a, 20a and outlet apertures 19b, 20b.

[0076] The inlet apertures 19a, 20a delimit on one side the respective terminal portions 14, 17 and through them, in use, the organic fluid that must be drained enters, while the outlet apertures 19b, 20b delimit, on the opposite side, the respective oblong portions 13, 16.

[0077] The first axial channel 19 and the second axial channel 20 may have constant section or may have narrowing or widening portions along their development.

[0078] With particular reference to FIG. 1, in a first operating condition of the device 10, the second terminal portion 17 is arranged outside the first tubular body 11 defining together with the first terminal portion 14 an end bifurcation that gives the device 10 a T shape. In the present case, the first terminal portion 14 and the second terminal portion 17 are folded with respect to the respective oblong portions 13, 16 so that the first tubular body 11 and the second tubular body 12 have an L shape.

[0079] The first terminal portion 14 and the second terminal portion 17 diverge, by way of example but not necessarily in a specular manner, from the axis of development of the respective tubular bodies 11, 12, determining a transverse bulk that is functional to the uptake necessary for the drainage of the specific area of the body.

[0080] The first terminal portion 14 and the second terminal portion 17 may be more or less tilted relative to the central body defined by the first tubular body 11 and the portion of the second tubular body 12 disposed therein. The mutual tilting of the aforementioned terminal portions 14, 17 is defined by the physical limitswalls or other structuresthat define the space that must be drained and by the flexibility of the material that constitutes them.

[0081] In a possible configuration that the device 10 can have in the first operating condition, the first terminal portion 14 and the second terminal portion 17 are arranged substantially aligned and specular so as to define the aforementioned bifurcation that takes on a real T conformation, and the second oblong portion 16 is aligned and inserted coaxially within the first oblong portion 13.

[0082] In the first operating condition, the first passage aperture 15 is engaged by a segment of the second tubular body 12, in particular by the second terminal portion 17, and the second passage aperture 18 is inside the first tubular body 11.

[0083] In the first operating condition, the second passage aperture 18 is substantially aligned and opposed to the first passage aperture 15. In this way, the first axial channel 19 is fluidly communicating with the second axial channel 20 through the second passage aperture 18. In this way, the organic fluid collected from the first end segment 14 can also flow into the second passage channel 20 to be drained outward.

[0084] In the first operating condition, the first passage aperture 15 is made substantially at the outer elbow that the first terminal portion 14 defines with the first oblong portion 13, and, similarly, the second passage aperture 18 is made substantially at the outer elbow that the second terminal portion 17 defines with the second oblong portion 16, FIG. 1.

[0085] With reference to FIG. 1, the second oblong segment 16 has a greater length than the first oblong segment 13 defining, in the first operating condition, a gripping portion 21 protruding from the first oblong segment 13 and having a length comprised between about 0.5 cm and about 4 cm, preferably around 1 cm. In particular, the gripping portion 21 is protruding from the outlet aperture 19b delimiting the first oblong portion 13. This gripping portion 21, opposed to the second terminal portion 17, can act as a gripping zone for the traction of the second tubular body 12 allowing the sliding of the second terminal portion 17 inside the first tubular body 11.

[0086] With particular reference to FIG. 2, in a second operating condition of the device 10 the first passage aperture 15 is free or is not engaged by the second tubular body 12 and the second terminal portion 17 is arranged inside the first tubular body 11.

[0087] In the second operating condition, the transverse bulk of the device 10 is reduced. In fact, the second terminal portion 17 which previously had a transverse direction, now has a configuration aligned both with the respective second oblong portion 16 and with the first oblong portion 13 of the first tubular body 11. This minimal bulk condition allows to greatly reduce the stresses that are caused during the removal of the device 10 from the patient's body.

[0088] In the transition from the first operating condition to the second operating condition the second tubular body 12 is forced to slide inside the first tubular body 11 so that the second terminal portion 17 is disposed therein and a part of the second oblong portion 16 exits the outlet aperture 19b delimiting the first oblong portion 13.

[0089] In the second operating condition, the second passage aperture 18 is misaligned with respect to the first passage aperture 15 and, in the configuration shown in FIG. 2, is directly facing the wall of the first axial channel 19.

[0090] The second operating condition may also comprise the configuration in which the second tubular body 12 is completely extracted from the first tubular body 11 through the aforementioned outlet aperture 19b.

[0091] According to embodiments, the external diameter D2 of the second tubular body 12 is slightly smaller than the internal diameter D1 of the first tubular body 11 which defines, moreover, the size of the first axial channel 19. It is advantageous, in fact, that the second tubular body 12 is substantially adherent to the first tubular body 11, but that mutual sliding is guaranteed. In this way, the organic fluid collected from the two terminal portions 14, 17 is conveyed all within the second axial channel 20.

[0092] With particular reference to FIGS. 6-8, when the device 10 is in the first condition of use and within the patient's body, the two terminal portions 14, 17 are arranged within the space to be drained, or even drainage space.

[0093] In the case illustrated in FIGS. 3-6, relating to liver transplant surgery, this drainage space is the bile duct choledochus 110 and the device 10 is able to drain the bile fluid out of the body to limit as much as possible contact with the surgical suture 111 that connects the bile duct of the recipient with that of the donor. In FIG. 3, the device 10 is in the first operating condition and the two terminal portions 14, 17 are inserted into the choledochus 110 while the remaining portion of the device 10 exits the choledochus 110 through an access aperture 112 that has the size of the external diameter of the first tubular body 11.

[0094] The embodiments illustrated in FIGS. 3-6 show the phases of an educational method for removing the device 10 from a corpse or from the body of a dummy, wherein the device 10, which is in the first operating condition, has the first and second terminal portions 14, 17 within the drainage space. The educational method for removing the device 10 provides at least:

[0095] a first extraction phase, FIG. 3-4, in which the second tubular body 12 is pulled from the gripping portion 21 until the second terminal portion 17 disengages the first passage aperture 15 and, for example, is positioned inside the first tubular body 11, and

[0096] a second extraction phase, FIG. 5, in which the device 10 is pulled in such a way as to allow the first terminal portion 14 to escape from the drainage space, in this case through the access aperture 112.

[0097] It is possible to provide that, in the first extraction phase, the second tubular body 12 is completely extracted from the first tubular body 11 following an extraction direction that initially disengages the first passage aperture 15 and subsequently the outlet aperture 19b of the first axial channel 19.

[0098] The described educational method for removal allows to reduce the efforts necessary to extract the device 10 from the specific drainage space. In fact, since the extraction of the second arm 17 takes place by sliding the second tubular body 12 inside the first tubular body 11, an excessive, and sometimes destructive, stress on the structures of the patient's body is avoided.

[0099] It is clear that modifications and/or additions of parts or phases may be made to the surgical drainage device described so far, without departing from the scope of the present invention as defined by the claims.

[0100] In the following claims, the references in parentheses have the sole purpose of facilitating reading and must not be considered as limiting factors as regards the scope of protection underlying the specific claims.