Device for the treatment of aortic pathologies in the abdominal and thoracoabdominal aortic tract

Abstract

A device (1) is provided for the treatment of aortic pathologies in the abdominal and thoracoabdominal aortic tract comprising a prosthesis (2) including an inlet duct (20) adapted to be sutured to a main blood vessel (V1) at an aneurysm and including a plurality of openings (20a) placed peripherally to the inlet duct (20), a pair of outlet ducts (21) formed by the bifurcation of the inlet duct (20) and each adapted to be sutured to a secondary blood vessel (V2), a plurality of secondary duct (22) each in fluid passage connection with the inlet duct (20) through a respective opening (20a) and each adapted to be sutured to an arterial branch (V3); and a plurality of radiopaque markers (3) each bound to a respective secondary duct (22) at the opening (20a).

Description

[0001] DESCRIPTION

[0002] DEVICE FOR THE TREATMENT OF AORTIC PATHOLOGIES IN THE

[0003] ABDOMINAL AND THORACOABDOMINAL AORTIC TRACT

[0004] The present invention relates to a device for the treatment of aortic pathologies in the abdominal and thoracoabdominal aortic tract of the type specified in the preamble of the first claim.

[0005] In particular, the present invention relates to a surgical prosthesis adapted to be introduced into the human body to surgically replace the paravisceral or thoracoabdominal abdominal aorta in case of the presence of aneurysm or other aortic pathologies.

[0006] As is known, aortic aneurysms are significant dilations of the aorta due to the failure of the aortic walls themselves. These aneurysms are very dangerous for the patient's life and, consequently, must be treated promptly.

[0007] Moreover, pathologies that more frequently affect the abdominal and thoracoabdominal aorta are known, such as dissections, intramural haematomas or penetrating ulcers, vasculitis, occlusive arteriopathies of the aorta, or also complications from previous surgical or endovascular interventions of the aorta that require definitive treatment.

[0008] Currently, aortic pathologies are treated either by open surgery or by an endovascular approach excluding the aortic lesions with endoprostheses.

[0009] The surgical approach is the most traditional method for treating aortic diseases and is still the preferred treatment when the aortic anatomy does not allow for endovascular treatment or in the case of young patients due to the superior durability of the prosthesis.

[0010] To perform the surgical treatment it is necessary to obtain adequate surgical access, by means of thoraco-phreno-laparotomy incision, and extracorporeal circulation to reduce the risk of visceral and spinal ischaemia.

[0011] In detail, it is possible to distinguish two different methods.

[0012] A first method, with straight dacron tube, in which proximal and distal anastomosis is performed with attachment of the paravisceral segment as a patch and it is possible to reattach the intercostal vessels and the lumbar vessels.

[0013] A second method, with dacron tube with 4 branches, for example made from a Coselli prosthesis, in which proximal and distal anastomosis is performed with attachment of the branches to the visceral vessels and, furthermore, of the intercostal vessels and the lumbar vessels.

[0014] The second method is the one preferred by most surgeons due to the low risk of paranastomotic pseudoaneurysms.

[0015] Endoprostheses are diametrically expandable tubular structures that can internally cover the aneurysm so as to reconstruct a proper channel for the flow of blood and exclude the aneurysmal sac from the blood flow itself.

[0016] To insert an endoprosthesis, a guide wire is first inserted along the aortic tract, for example under radioscopic guidance. The endoprosthesis is then advanced along the guide wire, while in a diametrically contracted configuration.

[0017] The endoprosthesis is then expanded to re-establish a new channel for the flow of blood.

[0018] In the case of extended aneurysms of the thoracic or abdominal aorta, involving the origin of important secondary arterial branches of the aorta itself, the endoprosthesis can cover the aorta and be provided with tubular extensions that are positioned at said arterial branches, also occupying the initial part of the latter, so as to allow blood flow in these secondary arterial branches while maintaining the exclusion of the aneurysmal sac.

[0019] For example, such branches may be the brachiocephalic trunk, the carotids, the subclavian, the renal arteries, the coeliac trunk, the superior mesenteric artery and the iliac artery.

[0020] In such cases it is necessary that the endoprosthesis provides openings and / or branches that extend, at least partially, into such arteries or branches.

[0021] For such operations so-called fenestrated or branched endoprostheses are sometimes used.

[0022] Such endoprostheses comprise, in fact, a plurality of branches and / or fenestrations for housing secondary endoprostheses that are inserted inside such arteries and that connect the body of the main endoprosthesis to such secondary arteries allowing blood flow and maintaining the exclusion of the aneurysmal sac from such flow.

[0023] In such cases, the physician passes a guide wire through the endoprosthesis, through a fenestration or a branch of the same endoprosthesis and also through at least a portion of a secondary artery, so as to then be able to guide the secondary endoprosthesis, also known as a stent-graft, and to position it bridging the body of the main endoprosthesis and the secondary artery, allowing blood flow and excluding the aneurysmal sac.

[0024] Said fenestrated endoprostheses, and the insertion of the secondary endoprostheses, involve several problems.

[0025] Firstly, in such areas, the aorta and the arteries branching from it have a high anatomical variability from one patient to the other patient, creating the necessity to resort to customised endoprostheses for each individual patient.

[0026] The production of said customised endoprostheses is carried out following a three- dimensional vascular study performed on the patient and a subsequent design and drawing of the prosthesis.

[0027] Said procedures are very long and complex and require a lengthy period for their completion with consequently extremely high costs.

[0028] Due to said costs and time, said processes are not always feasible.

[0029] Secondly, even in the case of a customised endoprosthesis, the procedure of cannulating the secondary arteries and positioning the secondary endoprostheses can be extremely complex and laborious. Indeed, the operator is forced to work with catheters and guide wires that must necessarily pass through the fenestrations or branches of the main endoprosthesis and try to cannulate the secondary arteries inside the aneurysmal sac under often unfavourable anatomical conditions.

[0030] Due to said complexity, the positioning of fenestrated endoprostheses requires long procedural times, prolonged radiological exposure of the patient and the operators, and the use of a large quantity of iodinated contrast medium.

[0031] In this situation, the technical task underlying the present invention is to devise a device for the treatment of aortic pathologies in the abdominal and thoracoabdominal aortic tract capable of substantially overcoming at least part of the aforementioned drawbacks.

[0032] Within the scope of said technical task, an important object of the invention is to achieve a device for the treatment of aortic pathologies in the abdominal and thoracoabdominal aortic tract that is simple and economical.

[0033] Another important object of the invention is to implement a device for the treatment of aortic pathologies in the abdominal and thoracoabdominal aortic tract which provides the same durability as currently known surgical prostheses, but low morbidity, thanks to reduced ischaemia and bleeding time, easy recovery and / or secondary reintervention if necessary.

[0034] The technical task and the specified objects are achieved by a device for the treatment of aortic pathologies in the abdominal and thoracoabdominal aortic tract as claimed in the annexed claim 1 .

[0035] Preferred technical solutions are highlighted in the dependent claims.

[0036] The features and advantages of the invention are clarified below by the detailed description of preferred embodiments of the invention, with reference to the accompanying drawings, in which:

[0037] Fig. 1 shows a schematic view of a device 1 for the treatment of aortic pathologies in the abdominal and thoracoabdominal aortic tract according to the invention;

[0038] Fig. 2 illustrates an example of use of a device 1 for the treatment of aortic pathologies in the abdominal and thoracoabdominal aortic tract according to the invention in which the device is replaced in the aortic tract and the secondary duct are sutured to a respective arterial branch;

[0039] Fig. 3 is a diagram of the orientations of the development projections on the section plane of a device for the treatment of aortic pathologies in the abdominal and thoracoabdominal aortic tract according to the invention in which the sectional view is taken from above, that is from the inlet duct towards the outlet ducts considering the upper part of the figure as facing the user's back and the lower part of the figure as facing the user's abdomen;

[0040] Fig. 4 represents a diagram of the orientations of the development projections on the section plane of a device for the treatment of aortic pathologies in the abdominal and thoracoabdominal aortic tract according to the invention in which the sectional view is taken from below, that is from the outlet ducts towards the inlet duct considering the upper part of the figure as facing the user's abdomen and the lower part of the figure as facing the user's back;

[0041] Fig. 5 shows a radiographic view of a device for the treatment of aortic pathologies in the abdominal and thoracoabdominal aortic tract according to the invention in which the different markers for each secondary duct are shown; and

[0042] Fig. 6 illustrates a further radiographic view of a device for the treatment of aortic pathologies in the abdominal and thoracoabdominal aortic tract according to the invention in which the different markers for each secondary duct are shown.

[0043] In the present document, the measurements, values, shapes and geometric references (such as perpendicularity and parallelism), when associated with words such as “approximately” or other similar terms such as “almost” or “substantially”, are to be understood as subject to measurement errors or inaccuracies due to production and / or manufacturing errors and, in particular, as subject to a slight deviation from the value, measurement, shape or geometric reference to which they are associated. For example, such terms, if associated with a value, preferably indicate a deviation not exceeding 10% of the value itself. Moreover, when used, terms such as “first”, “second”, “upper”, “lower”, “main” and “secondary” do not necessarily identify an order, a priority of relation or relative position, but may simply be used to more clearly distinguish between different components.

[0044] Unless otherwise specified, as appears from the following discussions, it is considered that terms such as “processing”, “computing”, “determination”, “calculation”, or similar, refer to the action and / or processes of a computer or similar electronic computing device that manipulates and / or transforms data represented as physical quantities, such as electronic quantities of registers of a computer system and / or memories into other data similarly represented as physical quantities within computer systems, registers or other memory, information transmission or display devices.

[0045] The measurements and data reported herein are to be considered, unless otherwise indicated, as made in International Standard Atmosphere ICAO (ISO 2533:1975).

[0046] With reference to the Figures, the device for the treatment of aortic pathologies in the abdominal and thoracoabdominal aortic tract according to the invention is globally denoted by the number 1.

[0047] It is adapted to treat aneurysms, in particular aneurysms of the aorta, for example of the abdominal aorta, that is, aneurysms affecting the connection area between the thoracoabdominal aorta and the arteries and / or its main branches.

[0048] The device 1 comprises a prosthesis 2.

[0049] The prosthesis 2 is preferably of the surgical type. Therefore, the prosthesis 2 is preferably adapted to replace an arterial tract.

[0050] The prosthesis 2 consists of a predominantly tubular structure, possibly comprising branches for example for said arteries or in addition / alternative for the iliac arteries. Moreover, the prosthesis 2 is preferably made of polyethylene terephthalate appropriately in amorphous form (transparent) or semi-crystalline form (white and opaque) such as for example polyethylene terephthalate commercially known as Dacron®.

[0051] The prosthesis 2 therefore comprises an inlet duct 20.

[0052] The inlet duct 20 is adapted to be sutured to a main blood vessel V1 , preferably the aorta, at an aneurysm.

[0053] The inlet duct 20 of the prosthesis, after its insertion, substantially constitutes the wall of the blood vessel replacing the natural ectatic wall.

[0054] Preferably, the inlet duct 20 develops along a trajectory 2a. The trajectory 2a is substantially the trajectory around which the inlet duct 20 develops and may therefore coincide with its central axis.

[0055] Moreover, the inlet duct 20 preferably defines a section plane 2b.

[0056] The section plane 2b is preferably perpendicular to the trajectory 2a. Therefore, the section plane 2b identifies the tubular profiles defined, along its extension, by the lateral walls of the inlet duct 20.

[0057] The inlet duct 20 therefore includes a plurality of openings 20a.

[0058] The openings 20a are placed peripherally to the inlet duct 20. Therefore, they are distributed on the lateral walls of the inlet duct 20 around the trajectory 2a.

[0059] The device 1 also comprises a pair of outlet ducts 21.

[0060] The outlet ducts 21 are formed by the bifurcation of the inlet duct 20. Therefore, each of the outlet ducts 21 is adapted to be sutured to a secondary blood vessel V2, for example an iliac artery.

[0061] Moreover, the device 1 also comprises a plurality of secondary ducts 22.

[0062] Each of the secondary ducts 22 is in fluid passage connection with the inlet duct 20. In detail, each of the secondary ducts 22 is in fluid passage connection with the inlet duct 20 through a respective opening 20a. Appropriately, the device 1 comprises one secondary duct 22 for each opening 20a.

[0063] Therefore, each of the secondary ducts 22 is also adapted to be sutured to an arterial branch V3, for example a renal artery.

[0064] The secondary ducts 22 may be configured according to specific modes.

[0065] In a preferred embodiment, in particular, the secondary ducts 22 each define their own direction of development 22a. The direction of development 22a is substantially the direction of orientation / development of the secondary duct 22 exiting from the inlet duct 20. Therefore, the direction of development 22a is preferably centred with respect to the respective opening 20a.

[0066] Moreover, the direction of development 22a defines, in turn, a development projection 22a’ on the section plane 2b.

[0067] The development projection 22a’ is actually the orthogonal projection of the direction of development 22a on the section plane 2b.

[0068] Therefore, each secondary duct 22 defines its own development projection 22a’ on the section plane 2b. Each of the development projections 22a’ has, in particular, its own orientation distinct with respect to the other development projections 22a’. Therefore, the secondary ducts 22 are oriented distinctly and thus angularly spaced with respect to the trajectory 2a.

[0069] Even more in detail, the secondary ducts 22 are preferably five in number.

[0070] For example, the secondary ducts 22 comprise at least a first secondary duct 22’, a second secondary duct 22”, a third secondary duct 22’”, a fourth secondary duct 22””, and a fifth secondary duct 22’””.

[0071] In a preferred embodiment, the second secondary duct 22” defines its own development projection 22a’ inclined by 31 ° clockwise with respect to the development projection 22a’ of the first secondary duct 22’.

[0072] The third secondary duct 22’” defines, instead, its own development projection 22a’ inclined by 95° clockwise with respect to the development projection 22a’ of the first secondary duct 22’.

[0073] The fourth secondary duct 22”” defines its own development projection 22a’ inclined by 57° counterclockwise with respect to the development projection 22a’ of the first secondary duct 22’.

[0074] Therefore, the fifth secondary duct 22””’ defines its own development projection 22a’ inclined by 97° counterclockwise with respect to the development projection 22a’ of the first secondary duct 22’.

[0075] Preferably, all the inclinations indicated are considered by observing the section plane 1 b of the device 1 from above, that is from the inlet duct 20 towards the outlet ducts 21. Naturally, if the inclinations indicated are instead to be interpreted by observing the section plane 1 b of the device 1 from below, that is from the outlet ducts 21 towards the inlet duct 20, Fig. 3 must be flipped upside down and the inclination angles must be understood as oriented in the opposite direction, that is, as shown in Fig. 4, with the second and third secondary duct 22”, 22’” inclined respectively by 31 ° and 95° counterclockwise with respect to the development projection 22a’ of the first secondary duct 22’ and the fourth and fifth secondary duct 22””, 22’”” inclined respectively by 57° and 97° clockwise with respect to the development projection 22a’ of the first secondary duct 22’.

[0076] The secondary ducts 22 may also define a particular distribution parallel to the trajectory 2a.

[0077] In particular, in the preferred embodiment, the section plane 2b is aligned with the development direction 22a of the first secondary duct 22’. Therefore, the development direction 22a of the second secondary duct 22” is preferably 19 mm away from the section plane 2b along the trajectory 2a.

[0078] Moreover, preferably, the development direction 22a of the third secondary duct 22’” is 35 mm away from the section plane 2b along the trajectory 2a.

[0079] The development direction 22a of the fourth secondary duct 22”” is 38 mm away from the section plane 2b along the trajectory 2a and, preferably, the development direction 22a of the fifth secondary duct 22””’ is 57 mm away from the section plane 2b along the trajectory 2a.

[0080] Preferably, in any case, the development direction 22a of the second secondary duct 22” is 19 mm away from the development direction 22a of the first secondary duct 22’ parallel to the trajectory 2a.

[0081] In addition or alternatively, the development direction 22a of the third secondary duct 22’” is preferably 16 mm away from the development direction 22a of the second secondary duct 22” parallel to the trajectory 2a.

[0082] Therefore, in addition or alternatively, the development direction 22a of the fourth secondary duct 22”” is preferably 3 mm away from the development direction 22a of the third secondary duct 22’” parallel to the trajectory 2a.

[0083] In conclusion, in addition or alternatively, the development direction 22a of the fifth secondary duct 22’”” is 19 mm away from the development direction 22a of the fourth secondary duct 22”” parallel to the trajectory 2a.

[0084] Similarly, in the preferred embodiment, the bifurcation is preferably 50 mm away from the development direction 22a of the fifth secondary duct 22’”” parallel to the trajectory 2a.

[0085] Therefore, for example, the bifurcation could also be 107 mm away from the aforementioned section plane 2b along the trajectory 2a, but this latter distance may vary for example depending on the size of the secondary duct 22.

[0086] In any case, advantageously, the device 1 comprises a plurality of markers 3.

[0087] The markers 3 are radiopaque. Therefore, they allow their detection when subjected to X-ray radiation since they inhibit the passage thereof through their body.

[0088] Advantageously, each of the markers 3 is bound to a respective secondary duct 22 at the respective opening 20a. Therefore, the markers 3 make it possible to identify the position of each secondary duct 22 when the device 1 is in use, inside the human body.

[0089] Even more in detail, preferably, one or more markers 3, preferably all, comprise a suitably radiopaque ring 30.

[0090] If present, the ring 30 is preferably placed perimetrically to a secondary duct 22 at a respective opening 20a.

[0091] Therefore, the marker 3 is also capable of allowing the determination of the development direction 22a of the respective secondary duct 22.

[0092] Moreover, each marker 3 may define a visually distinct conformation with respect to the other markers 3. In this way, it is possible to distinguish radiographically each of the secondary ducts 22 from the others starting from the identified marker 3. For example, as shown in Figs. 5-6, the markers 3, for example the rings 30 themselves, may comprise two separate radiopaque portions, or three or even more, so as to distinguish and individually identify each of the secondary ducts 22.

[0093] The operation of the device 1 for the treatment of aortic pathologies in the abdominal and thoracoabdominal aortic tract previously described in structural terms is analogous to the operation of any surgical device assigned to the same functions.

[0094] However, the device 1 for the treatment of aortic pathologies in the abdominal and thoracoabdominal aortic tract according to the invention achieves significant advantages.

[0095] Indeed, the device 1 for the treatment of aortic pathologies in the abdominal and thoracoabdominal aortic tract is simple and economical.

[0096] Moreover, the device 1 for the treatment of aortic pathologies in the abdominal and thoracoabdominal aortic tract allows the achievement of the same durability as currently known surgical prostheses, but with low morbidity, thanks to reduced ischaemia and bleeding time, easy recovery and / or secondary reintervention if necessary.

[0097] In particular, the device 1 for the treatment of aortic pathologies in the abdominal and thoracoabdominal aortic tract includes all the secondary duct 22 arranged in the correct positions for cannulation of the secondary arteries. Moreover, the correct positioning is easily verifiable thanks to the presence of the markers 3 which not only identify the position of the secondary ducts 22, but also their development direction 22a.

[0098] The invention is susceptible to variants falling within the scope of the inventive concept defined by the claims. Within such scope, all the details may be replaced by equivalent elements and the materials, shapes and dimensions may be any.

Claims

C LAI M S1. Device (1 ) for the treatment of aortic pathologies in the abdominal and thoracoabdominal aortic tract comprising:- a prosthesis (2) including:- an inlet duct (20) suitable for being sutured to a major blood vessel (V1 ) at an aneurysm and including a plurality of openings (20a) placed perimeterally to said inlet ducts (20),- a pair of outlet ducts (21 ) formed by the bifurcation of said inlet duct (20) and each suitable for being sutured to a secondary blood vessel (V2),- a plurality of secondary ducts (22) each in fluid passage connection with said inlet duct (20) through said one respective opening (20a) and each suitable for being sutured to an arterial branch (V3); and characterised by comprising:- a plurality of radiopaque markers (3) each bound to a respective said secondary duct (22) at said opening (20a).

2. Device (1 ) according to claim 1 , wherein one or more of said one or more said markers (3) comprise for each of said secondary ducts (22) a ring (30) radiopaque and placed peripherally to said secondary duct (22) around said one respective opening (20a).

3. Device (1 ) according to any of the previous claims, wherein each said marker (3) defines a visually distinct conformation with respect to said other markers (3) so that each said secondary duct (22) can be individually distinguished radiographically.

4. Device (1 ) according to any of the previous claims, wherein said inlet duct (20) predominantly develops along a trajectory (2a) and defines a section plane (2b)perpendicular to said trajectory (2a), said secondary ducts (22) each defining its own direction of development (22a) centered with respect to said respective opening (20a) and defining a development projection (22a') on said section plane (2b) having its own orientation distinct from said other development projections (22a').

5. Device (1 ) according to the previous claim, wherein said secondary ducts (22) are five in number.

6. Device (1 ) according to any of the previous claims, wherein said secondary ducts (22) comprise at least:- a first secondary duct (22'),- a second secondary duct (22') defining its own said development projection (22a') inclined 31 ° clockwise from said development projection (22a') of said first secondary duct (22'),- a third secondary duct (22a') defining its own said development projection (22a') inclined by 95° clockwise from said development projection (22a') of said first secondary duct (22'),- a fourth secondary duct 22"") defining its own said development projection (22a') inclined by 57° counterclockwise to said development projection (22a') of said first secondary duct (22'), and- a fifth secondary duct (22 ) defining its own said development projection (22a') inclined by 97° counterclockwise to said development projection (22a') of said first secondary duct (22').

7. Device (1 ) according to any of the previous claims, wherein said section plane (2b) is aligned with said development direction (22a) of said first secondary duct (22'), said development direction (22a) of said second secondary duct (22") being 19 mm away from said section plane (2b), said development direction (22a)of said third secondary duct (22") is 35 mm away from said section plane (2b), said development direction (22a) of said fourth secondary duct (22"") is 38 mm away from said section plane (2b), and said development direction (22a) of said fifth secondary duct (22 ) is 57 mm away from said section plane (2b).

8. Device (1) according to at least claim 6, wherein said development direction (22a) of said second secondary duct (22") is 19 mm away from said development direction (22a) of said first secondary duct (22") parallel to said trajectory (2a) and / or said development direction (22a) of said third secondary duct (22") is 16 mm away from said development direction (22a) of said second secondary duct (22") parallel to said trajectory (2a), and / or said development direction (22a) of said fourth secondary duct (22"") is 3 mm away from said development direction (22a) of said third secondary duct (22") parallel to said trajectory (2a), and / or said development direction (22a) of said fifth secondary duct (22 ) is 19 mm away from said development direction (22a) of said fourth secondary duct (22"") parallel to said trajectory (2a).

9. Device (1 ) according to at least claim 6, wherein said bifurcation is 50 mm away from said development direction (22a) of said fifth secondary duct (22 ) parallel to said trajectory (2a).

10. Device (1 ) according to any one of claims 6-9, wherein said bifurcation is 107 mm away from said section plane (2b).

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