MEDICAL DEVICE FOR CLOSING FISTULAS, INSTRUMENT FOR THE POSITIONING THEREOF, AND METHOD FOR THE POSITIONING AND EXTRACTION OF THE DEVICE USING SAID INSTRUMENT

Abstract

The medical device has an element including two discs, small (5) and large (6), joined by a central part (7), the structure of the element being determined by a nitinol core (8) with sufficient flexibility to be folded over itself and inserted in a flexible instrument (9) suitable for incorporation in an endoscope or similar device. Also included is a layer (10) of soft material, such as polyurethane, silicone or another polymer that covers the core (8). The core (8) is filamentous and forms at least the two discs (5, 6) via spokes (81) and the central part (7) via a rod (82). The instrument (9) includes a capsule (11) in which the device (1) that is folded over itself is accommodated, and a catheter (12) that can be connected to the capsule (11), with a pushing mechanism (14) for expelling the device (1) from the capsule (11) in a controlled manner

Claims

1. A medical device for closing fistulas, namely designed for closing a fistula (2) in the wall (3) of a canal (4) of a human organ that, consisting in an element the structure of which shows two circular or oval discs (5,6), one small (5) designed to remain positioned covering the fistula (2) by the internal part of the wall (3) and one large (6) designed to be positioned by the external part of the said wall (3) the said discs (5, 6) being joined by a central part (7) that delimits the gap between both to the distance required, is characterized in that the said structure comprises a Nitinol core (8) having sufficient flexibility to be folded over itself and inserted in a flexible instrument (9) suitable for the incorporation in an endoscope or similar device and a layer (10) of soft material such as polyurethane, silicone or other polymer that covers the central part (8).

2. The medical device for closing fistulas, according to claim 1 characterized in that the Nitinol core (8) is filamentous.

3. The medical device for closing fistulas, according to the claim 2 characterized in that the Nitinol core (8) forms, at least, the two discs (5, 6) via several spokes (81) joined by their central part.

4. The medical device for closing fistulas, according to claim 3 characterized in that the Nitinol core (8) forms the two discs (5, 6) via three spokes (81) equidistant at 120.

5. The medical device for closing fistulas, according to claim 2 characterized in that the Nitinol core (8) forms the central part (7) that joins both discs via a rod (82).

6. The medical device for closing fistulas, according to claim 5, characterized in that the central part (7) is a rod (82) having an extension (83) emerging by the external part of one of the discs (6) serving as supporting basis to facilitate its positioning with the instrument (9).

7. The medical device for closing fistulas, according to claim 1 characterized in that, at least, the discs (5, 6) formed by the Nitinol core (8) are fully covered by a layer of soft material (10).

8. The medical device for closing fistulas, according to claim 7 characterized in that the central part (7) of the Nitinol core (8) is also covered by a layer of soft material (10).

9. The medical device for closing fistulas, according to claim 7 characterized in that the layer of soft material (10) is preferably of polyurethane.

10. An instrument for positioning the device (1) for closing fistulas characterized in that the said instrument (9) is flexible and suitable for the incorporation in an endoscope or similar device and comprises a delivering capsule (11) suitable for housing the closing device (1) folded over itself and a catheter (12) that is connected to the capsule (11), which has a pushing means (14) to push and expel under control the device (1) out of the capsule (11) and that, in turn, can be inserted through the working channel of the endoscope or similar instrument.

11. The instrument, according to claim 10, characterized in that the catheter (12) is connected to the capsule (11) though retention means (13).

12. The instrument according to the claim 10, characterized in that the capsule (11) is a hollow cylinder open at both ends.

13. The instrument according to claim 10, characterized in that the capsule (11) is transparent.

14. The instrument, according to claim 10, characterized in that the capsule (11) is preferably of transparent polyurethane or silicone.

15. The instrument, according to claim 10, characterized in that the said retention means (13) that connect the capsule (11) by its part proximal to the distal end of the catheter (12), comprise protrusions (131) between which there exists a gap where a complementary thickening (121) provided at the said distal end of the catheter (12) is fitted under pressure.

16. The instrument, according to claim 10, characterized in that the catheter (12) has a diameter much smaller than the capsule (11).

17. The instrument, according to claim 10, characterized in that the pushing means (14) of the catheter (12) consists in a piston-like means formed by a stem (141) that, when screwing a button (142) of the proximal end of the catheter (12) moves towards the distal end of the capsule (11) being capable to push the closing device (1) housed within it.

18. A process for positioning a device (1) for closing a fistula characterized in that it comprises the following steps: inserting a catheter (12) through a working channel of the endoscope or similar instrument until a distal end of the catheter (12) is outside the endoscope; selecting a delivering capsule (11) having a correct size, introducing a device (1) folded over itself into it and connecting a proximal end of the device to the distal end of the catheter (12); inserting in a relevant hole of a human body the endoscope or similar with the catheter (12) and a capsule (11) containing the device (1) until positioning the distal end of the capsule (11) just at the beginning of the fistula (2); actuating a pushing means (14) of the catheter (12) by pushing a first disc (5) of the device (1) within the fistula (2), that is unfolded remaining against an internal wall of the the fistula; and pulling backwards from an assembly of the endoscope or similar instrument the catheter (12) and capsule (11), allowing that a second disc (6) is unfolded flush against the external wall of the fistula (2)

19. The process for positioning, according to claim 18, characterized in that the closing device (1) is introduced folded over itself in the capsule (11) with the spokes (8) of each disc oriented towards opposite ends and with their respective vertices facing each other, having care that the small disc (5) remains at the more external point thereof, while the large disc (6) remains at the more proximal point of the capsule (11).

20. A process for extracting a medical device (1) for closing fistulas in a body, characterized in that it comprises: using an incorporated suitable gripping means that is introduced through an endoscope and pulling the medical device (1) fastening the medical device (1) with one of the discs until the other disc (5) is fully folded and crosses the wall of the fistula; and extracting the medical device (1) out of the body.

Description

DESCRIPTION OF THE DRAWINGS

[0035] To complement the description that is been done and in order to assist to a best understanding of the characteristics of the invention, attached to this specification, as an integral part thereof, is a set of drawings in which with illustration and non-limiting purpose the following has been represented:

[0036] The FIG. 1.It shows a view in perspective of an example of preferred embodiment of the medical device for closing fistulas, object of the invention, where the parts and elements it comprises can be seen;

[0037] The FIGS. 2 and 3.They show schematic plan views of two examples, circular and oval, respectively, of a preferred configuration of the discs of the closing device of the invention.

[0038] The FIG. 4.It shows a very schematic and elevation view of the rod forming the connecting central part between both discs of the device, according to the invention; and

[0039] The FIGS. 5 to 11.They show a series of schematic views of the sequence of the process of positioning the device of the invention and the instrument used in the said process. Concretely, the FIG. 5 shows the folding movement of the discs, the FIG. 6 shows the device after it is folded over itself and before its implementation, the FIG. 7 shows a cross view of the delivering capsule with the device housed within it; the FIG. 8 shows a perspective of the catheter where the internal pushing means can be seen, the FIG. 9 shows the catheter already coupled to the delivering capsule, the FIG. 10 shows the unfolding of the first disc on the internal wall of the fistula after positioning the instrument in the body of the patient with an endoscope and the FIG. 11 shows the extraction of the instrument after the unfolding of the second disc of the closing device on the external wall of the fistula.

PREFERRED EMBODIMENT OF THE INVENTION

[0040] Seen the said figures and according to the numbering adopted, a non-limiting example of the medical device for closing fistulas of the invention and of the instrument used for the positioning thereof can be seen that comprises the parts and elements mentioned and disclosed in details below.

[0041] Thus, in the said figures, the device (1) involved can be seen, designed to closing a fistula (2) on the wall (3) of a canal (4) of a human organ, that consists in a manner already known, of an element the structure of which has two circular discs (5, 6), one small (5) designed to remain positioned covering the fistula (2) by the interior part of the wall (3) and one large (6) designed to be positioned by the external part of the said wall (3), both discs (5,6) being joined by a central part (7) that delimits the gap between them at the distance required, with the peculiarity that the said structure has a Nitinol core (8) providing it with a flexibility such that allows its folding over itself and its insertion in a specific flexible instrument (9) (see FIGS. 9, 10 and 11) that, in turn, is adapted to be incorporated in an endoscope or similar device.

[0042] More concretely, the Nitinol core (8) forms, at least, the two discs (5, 6) via filaments, concretely via several spokes (81), preferably three equidistant spokes, joined at their centre and, preferably, it also forms the central part (7) that joins both discs at the said centre, via a straight rod (82).

[0043] In addition, preferably, the said rod (82) has an extension (83) that emerges by the external part of one of the discs, preferably that of the large disc (6) serving as support base to facilitate its positioning by means of the instrument (9).

[0044] Anyway, in the preferred embodiment, at least the two discs (5,6) of the device (1) formed by the Nitinol core (8) are in addition fully covered by a layer (10) of soft material, of polyurethane, silicone or other polymer, circular or oval shaped, although, in the preferred option of the invention, also the central part (7) formed by the straight rod (82) of the Nitinol core (8) is covered by the said layer (10) of soft material.

[0045] Referring to the FIGS. 2 to 11, the main steps of the process of positioning the device (1) of the invention using the said flexible instrument (9) is seen, which essentially comprises a delivering capsule (11), suitable to house the closing device (1), folded over itself, and a catheter (12) that is connected to the capsule (11) via retention means (13), provided in turn with a pushing means (14) to push and expel under control the device (1) and that this way, can be inserted through the working channel of an endoscope or other similar instrument.

[0046] The capsule (11) consists of a hollow cylinder open by both ends and transparent, preferably of transparent polyurethane or silicone and that is connected by its proximal part to the distal end of the catheter (12) by means of the said retention means (13) that, preferably, comprise protrusions (131) between which there exists a gap where a complementary thickening (121), provided at the said distal end of the catheter (12) is fitted under pressure.

[0047] As for the catheter (12), it has a diameter much smaller than the one of the capsule (11) and the pushing means (14), preferably, consists of a piston-like element formed by the stem (141) that, when screwing a button (142) of the proximal end of the catheter (12) moves towards the distal end of the capsule (11) being capable to push the closing device (1) housed within it, preferably affecting the extension (83) of the rod (82).

[0048] As for the steps of the process for positioning the closing device (1) they are essentially as follows: [0049] Inserting the catheter (12) through the working channel of the endoscope or similar instrument until its distal end is out of it. [0050] Choosing a delivering capsule (11) having a correct size, introducing the device (1) folded over itself in it and connecting its proximal end to the distal end of the catheter (12). [0051] Introducing the device (1) folded over itself in the capsule (11) with the spokes of each disc oriented towards opposite ends and with their respective vertices facing each other, having care that the small disc (5) remains at the more external point thereof, while the large disc (6) remains at the more proximal point of the capsule (11). [0052] Inserting in the relevant hole of the human body the endoscope or similar with the catheter (12) and the capsule (11) that contains the device (1) until positioning the distal end of the capsule (11) just at the beginning of the fistula (2). [0053] Actuating the pushing means (14) of the catheter (12) by pushing the first disc (5) of the device (1) within the fistula, that is unfolded remaining flush against the internal wall of the canal (2). [0054] Pulling backwards the set of the endoscope or similar instrument, catheter (12) and capsule (11), allowing that the second disc (6) is unfolded flush against the external wall of the fistula.

[0055] As for the process of extraction of the device (1) it consists of: [0056] Using an incorporated suitable gripping means, such as a biopsy forceps, that is introduced through the endoscope and pulling the device (1) fastening it with one of the discs until the other disc (5) is fully folded and crosses the wall of the fistula. [0057] Extracting the full closing device (1) out of the body.

[0058] The nature of this invention being sufficiently disclosed as well as the way of implementing it, it is not deemed necessary to extend any longer this explanation in order that any person skilled in the art comprises the extent and the advantages derived from it, and it can be reimplemented in other embodiments differing in detail of the indicated for example purpose provided that the fundamental is not altered, changed or modified.