IT202100006239A1 - EMBOLIC PROTECTIVE DEVICE - Google Patents

Description

TITLE: EMBOLIC PROTECTIVE DEVICE

Description

Field of invention

The present invention relates to an embolic protection device, and to a kit comprising a transseptal puncture device and said embolic protection device. Pi? in particular, the present invention relates to an embolic protection device and relative kit capable of guaranteeing systemic protection against emboli which form during interventional cardiology operations on the structures of the left heart.

State of art

Operations involving structures of the left heart are associated with a variable but significant risk of cerebral and systemic thromboembolism. These procedures are currently growing and include: ablation of arrhythmias (e.g. atrial fibrillation), closure of atrial septal defects, percutaneous closure of the left atrial appendage, percutaneous aortic valve replacement, and valve interventions mitral (mitral valvuloplasty, mitral clip).

The subjects subjected to these interventions were particularly exposed to ischemic cerebrovascular events or strokes attributable to embolization, or to systemic embolism in general, i.e. to the dissemination in the systemic circulation of thrombi or tissue fragments formed during the operation.

Some embolic protection devices are known in the art which are suitable for preventing the passage of emboli generated during the aforesaid operations in the cerebral arteries. However, these devices are not able to completely and totally protect all the arteries that supply the brain, and even less are they able to guarantee systemic protection. Furthermore, the known devices require a femoral arterial vascular access, which is unsafe and prone to potential complications.

To date ? An embolic protection device with right radial vascular access was developed. However, it provides incomplete protection. Such a device? described in EP 2 387 427 and comprises a first filter configured to be positioned in the brachiocephalic trunk and a second filter configured to be positioned in the left common carotid artery. because this device does not provide for the filtering of the emboli through the left subclavian artery, from which the left vertebral artery originates, it? capable of guaranteeing only partial cerebral protection. Furthermore, due to its particular structure, this device can be inserted only through the right radial artery, resulting thus? not very versatile.

Therefore, the problem underlying the present invention ? that of providing an embolic protection device to be used during any interventional cardiology operation on a structure of the left heart which allows the capture of any embolism that may be generated, guaranteeing not only complete cerebral protection but also systemic protection, and that allows easy, safe and versatile placement of the embolic protection device.

Summary of the invention

The above problem? resolved by an embolic protection device and a kit comprising a transseptal puncture device and said embolic protection device as outlined in the appended claims, the definitions of which form an integral part of the present description.

A first object of the invention? a total embolic protection device configured to be inserted through either the right radial artery or the left radial artery, said device comprising:

a deployable conical filter comprising one end? open distal configured to occlude the aortic lumen in the suprabulbar area when said filter ? deployed, said extremity? distally open forming a circular or substantially circular opening having a diameter of between 3.0 cm and 5.5 cm when said filter ? unfolded;

a guide catheter for said conical filter having an outer diameter not exceeding 6 French, e

a cable secured to said conical filter and configured to maneuver, i.e., deploy and retract, said conical filter.

A further object of the present invention ? a kit comprising said embolic protection device and a transseptal puncture device, wherein said transseptal puncture device comprises a needle configured to puncture the interatrial septum, a dilator, and a guide catheter for said needle.

Advantageously, the device and the kit according to the present invention are capable of providing complete embolic protection, both at a cerebral level and at a systemic level. This means that all the emboli that can be generated during interventional cardiology operations involving structures of the left heart are captured and, consequently, the dissemination of emboli in the systemic circulation is prevented.

The expression ?supra-bulbar? ? used to indicate the portion of the ascending aorta just above the aortic bulb. In the following description the expressions ?in the suprabulbar area?, ?at the suprabulbar level? and ?supra-bulbar position? they are used interchangeably.

The expression ?occlude the aortic lumen? denotes that the conical filter in accordance with the present invention, when deployed, is such as to occupy the entire aortic lumen in the suprabulbar area adhering to the walls of the ascending aorta, or ? such as to occupy the entire cross section of said lumen.

Advantageously, the conical filter of the embolic protection device according to the invention is configured to be housed, when deployed, distal to the aortic bulb (that is, in the supra-bulbar area), or in the vicinity? of the origin of the systemic flow, thus ensuring? the total filtering of all blood flow originating from the heart.

As described above, when said filter ? deployed, its extremity? open distal forms a circular or substantially circular opening. The expression ?substantially circular? denotes that this opening can? not be a perfect circumference, as the? extremity? distal of the conical filter, when this ? unfolded, it adheres to the walls of the aortic lumen in the suprabulbar area and said opening therefore assumes the shape of the cross section of said lumen. The expression ?substantially circular? denotes that this opening can? also have an oval or ellipsoidal shape.

Advantageously, the? extremity? distal of said conical filter ? open in such a way as to trap inside any emboli and micro-emboli which, frequently and dangerously, form during interventional cardiology operations on the structures of the left heart.

The end? distal of said conical filter ? such that, when said filter ? unfolded, it gently adheres to the walls of the ascending aorta, totally occupying the lumen at the supra-bulbar level. The end? distal of said conical filter, when the latter? fully deployed, it forms an opening whose diameter is ? between 3.0 cm and 5.5 cm, preferably between 3.0 cm and 4.5 cm, plus? preferably between 3.2 cm and 4.0 cm, substantially corresponding to the diameter of the ascending aorta at the suprabulbar level, which varies from subject to subject based on sex, age and and build, or body mass index.

Said guide catheter has an external diameter not exceeding 6 French, for example not exceeding 5.5 French or 5 French.

Preferably, said guide catheter ? coated with a hydrophilic material capable of ensuring its most? easy progression through the? artery from which ? inserted and greater atraumaticit?.

How already? exposed above, said conical filter ? fixed to a special cable (or wire). Preferably, said cable ? metallic. Said cable has one end? proximal and one end? distal and, preferably, said conical filter ? fixed at? the extremity? distal of this cord. Preferably, said conical filter ? fixed to said cable through its extremity? proximal, opposite to? extremity? open distal configured to occlude the aortic lumen at the suprabulbar level.

In one embodiment of the invention, said guide catheter ? provided at its end? proximal of a one-way valve designed to prevent the reflux of arterial blood, and of a small drain tube with a two-way stopcock for the outflow of blood (side-port).

Advantageously, said guide catheter has such a length that the conical filter can be easily housed in the ascending aorta in a suprabulbar position once said embolic protection device is installed. inserted through the right radial artery or the left radial artery of the forearm.

Preferably, said guide catheter has a length substantially equal to the distance existing between the aortic bulb and the entrance of the right radial artery or of the left radial artery. With ?aortic bulb? refers to the entrance of the aortic bulb, or rather the suprabulbar site of the ascending aorta. The expression ?substantially equal to? denotes a length such as to cover the distance between the aortic bulb and the entrance of the right radial artery or the left radial artery and such that the guide catheter can be maneuvered outside the human body. It follows that the expression ?substantially equal to? denotes a length slightly greater than the typical distance between the aortic bulb and the inlet of the right radial artery or left radial artery, for example a length exceeding up to 10 cm, plus preferably up to 5 cm, the distance between the aortic bulb and the entrance of the artery in question.

Preferably, said guide catheter has a length not exceeding 140 cm, more than preferably not higher than 130 cm, even more? preferably not exceeding 125cm, 110cm, 100cm.

Advantageously, said cable to which ? fixed, the conical filter extends at least partially inside said guide catheter. Preferably, said cable extends coaxially to the guide catheter.

Advantageously, said cable to which ? once fixed, the conical filter has a length greater than the length of the guide catheter so that said cable can be handled and, therefore, said conical filter can be removed from the guide catheter or reintroduced inside it by acting on said cable. Preferably, the length of said cable exceeds the length of the guide catheter by a maximum of 10 cm. Preferably, said cable has a length not exceeding 150 cm, more than preferably not higher than 140 cm, even more? preferably not higher than 130cm or 120cm.

In a preferred embodiment of the invention, said conical filter comprises a filter mesh (or membrane) and a support ring which defines the end of the filter. open distal of the filter. When the conical filter ? unfolded, said ring advantageously assumes a circular or substantially circular shape, in accordance with the definitions given above.

Advantageously, said filter mesh comprises a plurality of openings (or pores) having a surface area such as to let the blood cells pass, but such as to block the passage of emboli and micro-emboli. Preferably, said openings have a diameter between 120 ?m and 200 ?m, more? preferably between 140 ?m and 160 ?m.

Preferably, said filter mesh ? made of a flexible biocompatible material, for example, polyethylene, polypropylene, polyurethane, polyester, nylon or polytetrafluoroethylene, or combinations thereof.

Advantageously, said support ring ? made of an elastically recoverable material such as a biocompatible elastomeric polymer, spring steel, stainless steel, nickel-titanium alloy, or the like, or combinations thereof, capable of providing the support ring with the ability to to open automatically when the filter is removed from the guide catheter in which ? inserted (?self-opening function?). Preferably, said conical filter ? made of a superelastic material, preferably a nickel titanium alloy (?nitinol?).

As better described below, during the retraction phase of the conical filter, the support ring bends, wrapping itself around itself? itself, to collapse and retract the conical filter inside the guide catheter. When the conical filter ? unfolded, said support ring resumes its circular or substantially circular shape.

In an embodiment according to the present invention, said embolic protection device further comprises a dilator configured to be inserted within said guide catheter, said dilator having a closed end. distal tapering emerging from said guide catheter. Said dilator is used at the time of positioning the guide catheter. During the use of the embolic protection device, said dilator is inserted inside the guide catheter to allow the atraumatic positioning of the latter at the level of the ascending aorta in the supra-bulbar area, preferably with the aid of a guide J 0.035 inch conventional.

In an embodiment according to the present invention, said embolic protection device further comprises a connector configured to transfer the conical filter into the guide catheter (after the dilator and guidewire have been removed), said connector being such as to prevent it from being trapped air, adequate venting (removal of air) should be performed and the guide catheter flushed continuously to avoid obstruction.

Preferably, said connector includes a first tubular element comprising an end for the input of the conical filter and a? extremity? opposite, preferably provided with a circular tap in the shape of a ring nut, for the outlet of the cable fixed to said conical filter, and a second tubular element fixed to said first tubular element and comprising one end? for the inlet of the washing liquid of the filter and the guide catheter. Preferably, said first tubular element and said second tubular element define an angle between 15? and 60?, more? preferably in 30? and 45?.

As described above, the transseptal puncture device included in the kit according to the present invention comprises a needle, a dilator and a guide catheter.

Preferably, said needle has a curvature at one of its ends, in particular at the configured to puncture the atrial septum. Preferably, said curvature defines an angle between 30? and 60?, more? preferably around 50?. Preferably, said needle has a length between 50 cm and 110 cm, more preferably between 55 cm and 100 cm, for example 56 cm, 71 cm, 89 and 98 cm.

Preferably, said dilator has an external diameter of between 8 and 9 French, for example 8.5 French. Preferably, said expander has a length of between 60 and 70 cm, for example 67 cm. Said dilator? configured to be inserted into the guide catheter. Preferably, said dilator has an? tapered distal that emerges from said guide catheter to favor its atraumatic progression from the femoral vein towards the right atrium.

Preferably, said guide catheter has an external diameter of between 8 and 9 French, for example 8.5 French. Preferably, said guide catheter has a length of between 60 and 70 cm, for example 63 cm.

Preferably, said guide catheter ? coated with a hydrophilic material along its entire length for a pi? easy insertion through the skin and a pi? easy atraumatic progression through the femoral vein.

Preferably, said guide catheter has a curvature in its distal portion corresponding to the curvature of the needle. With the term ?distal section? we mean the section that enters the heart.

Preferably, said guide catheter ? endowed at its end? proximal of a one-way valve designed to prevent the reflux of arterial blood, and of a small drain tube with a two-way stopcock for the outflow of blood (side-port).

One method to guarantee complete embolic protection, both at a cerebral and at a systemic level, during an operation involving a structure of the left heart envisages housing the aforementioned conical filter inside the ascending aorta in the supra-bulbar area, therefore leave it in place for the entire duration of the operation, and only remove it once the operation has been completed.

In one embodiment, said method involves inserting the guide catheter through the right radial artery, and positioning it in the ascending aorta in the suprabulbar location, passing through the brachiocephalic trunk.

In another embodiment, said method involves inserting the guide catheter through the left radial artery, and positioning it in the ascending aorta in the supra-bulbar location, passing through the left subclavian artery.

Advantageously, said guide catheter is positioned in the ascending aorta in the suprabulbar location by means of the aid of a suitable guide (or guide wire), preferably a conventional J 0.035 inch guide.

Advantageously, the aforementioned dilator allows the guide catheter to be positioned atraumatically. Preferably, the guide catheter/dilator assembly is advanced on said guide, previously inserted from the radial arterial access point, up to the suprabulbar site of the ascending aorta.

In accordance with a preferred embodiment, once the guide catheter/dilator assembly has reached the ascending aorta in suprabulbar position, the dilator is withdrawn together with the guide and the conical filter is inserted inside the guide catheter , then advanced to the end? distal and positioned in the ascending aorta in the suprabulbar area thanks to a retraction of the guide catheter which determines the distal opening of the filter.

Advantageously, the? extremity? distal part of the deployed conical filter adheres to the walls of the ascending aorta at the suprabulbar level, occupying it completely. With the filter deployed in the ascending aorta in the suprabulbar area, the interventional cardiology operation on a structure of the left heart was ? conducted safely and any emboli generated are trapped inside the filter, which thus prevents? the free movement of emboli in the arteries.

Operations involving the structures of the left heart involve the execution of the so-called trans-septal catheterization, which consists in the puncture of a membrane of the heart called the interatrial septum, which divides the right atrium from the left one.

Once the intervention is completed, the conical filter is retracted and folded inside the guide catheter, which, according to one embodiment, is? remained distal. The guide catheter is then withdrawn from the artery through which it was inserted. Through this procedure, any embolism that is generated is trapped inside the conical filter and safely removed from the body.

Further characteristics and advantages of the invention will become clearer from the description of some embodiments, given hereinafter for indicative and non-limiting purposes.

Brief description of the figures

Figures 1A-1C show, respectively, the deployed filter and the filter in two different stages of retraction relative to the guide catheter of the embolic protection device according to an embodiment of the present invention.

Figures 2A-2B show, respectively, the dilator and the dilator inserted into the guide catheter of the embolic protection device according to an embodiment of the present invention.

Figures 3A-3B show, respectively, the deployed filter and the retracted filter within the connector of the embolic protection device according to an embodiment of the present invention.

Figure 4 shows the embolic protection device inserted through the right radial artery and housed in the ascending aorta in the suprabulbar area, during interventional cardiology surgery on a structure of the left heart.

Detailed description of the figures

Figures 1A-1C show the embolic protection device 1 in accordance with an embodiment of the present invention comprising a conical filter 2, a cable 3 to which said filter ? fixed and a guide catheter 4 for said filter. In this embodiment, the conical filter 2 has one end? proximal 5 fixed to the cable 3 and one end? open distal 6. Said cavity 3 ? visible from Figure 1A.

In Figure 1A, the conical filter 2 ? in its unfolded form and the? extremity? open distal 6 forms a circular or substantially circular opening such as to occlude the lumen of the ascending aorta in the suprabulbar area (not shown) in which the conical filter 2 will be placed? lodged during an interventional cardiology operation on a structure of the left heart, or such as to occupy the entire section of said lumen.

In Figure 1B, the conical filter 2 ? in a first step of retraction inside the guide catheter 4. The direction of retraction of the conical filter 2 ? indicated by the arrow A in the figure.

In Figure 1C, the conical filter 2 ? in a second phase of retraction inside the guide catheter 4. Also in this figure, the direction of retraction of the conical filter 2 ? indicated by the arrow A.

Figure 2A shows a dilator 7 configured to be inserted into the guide catheter 4. The dilator 7 has one end? tapered 8. As illustrated in Figure 2B, the dilator 7 extends for a length X1 coaxially inside the guide catheter 4 and for a length X2 coaxially with the guide catheter 4 but outside it.

Figures 3A-3B show a connector 9 comprising a first inlet 10 for the conical filter 2, a second inlet 11 for the washing liquid of the guide catheter 4 and of the conical filter 2, and an outlet 12 from which emerges the cable 3 to whom ? fixed the conical filter 2.

In Figure 3A, ? The loading of the conical filter 2 inside the connector 9 through the inlet 10 is illustrated. The direction of retraction of the conical filter 2 inside the connector 9 is indicated by the arrow B in the figure. The insertion of the washing liquid through the inlet 11 ? indicated with the arrow C in the figure.

In Figure 3B, ? shown the conical filter 2 loaded in the connector 9 and ready to be transferred into the guiding catheter 4.

Figure 4 shows the conical filter 2 deployed in the suprabulbar position BA in the ascending aorta AA during surgery on a structure of the left heart. In the embodiment illustrated in Figure 4, the conical filter 2 is inserted, through the guide catheter 4, through the right radial artery RD. In this embodiment, with the aid of a suitable guidewire and a dilator (not shown), said guide catheter 4 is positioned at the suprabulbar level BA, passing through the brachiocephalic trunk TB. Once the suprabulbar position BA has been reached and the guide wire and dilator (not shown) have been withdrawn, the conical filter 2 is advanced through the guide catheter 4 by manipulating the cable 3 which ? fixed, then deployed by retraction of guide catheter 4. Conical filter 2 will remain? in place for the entire duration of the intervention. As visible in Figure 4, the deployed conical filter 2 adheres to the walls of the ascending aorta AA in the supra-bulbar position BA occupying it completely.

? It is clear that what has been described are only particular embodiments of the present invention. The art expert will be capable of making all the necessary modifications to the embolic protection device and to the relative kit for its adaptation to particular conditions, without however departing from the scope of protection as defined in the appended claims.

Claims (10)

1. Embolic protection device (1) configured to be inserted without distinction through the right radial artery or the left radial artery, said device (1) comprising: a deployable conical filter (2) comprising one end? open distal (6) configured to occlude the aortic lumen in the suprabulbar area when said filter (2) ? deployed, said extremity? open distal (6) forming a circular or substantially circular opening having a diameter between 3.0 cm and 5.5 cm when said filter (2) is unfolded; a guide catheter (4) for said conical filter (2) having an external diameter not exceeding 6 French, and a cable (3) fixed to said conical filter (2) and configured to maneuver said conical filter (2). 2. Device (1) according to claim 1, wherein said cable (3) comprises one end? proximal and a? extremity? distal, and in which said conical filter (2) ? fixed at? the extremity? distal of said cable (3) through its extremity? proximal (5). 3. Device (1) according to claim 1 or 2, wherein said guide catheter (4) has a length substantially equal to the distance existing between the aortic bulb of the ascending aorta and the entrance of the right radial artery or of the radial artery left, preferably not more than 140 cm, pi? preferably not higher than 130 cm, even more? preferably not exceeding 110 cm. 4. Device (1) according to any one of the preceding claims, wherein said cable (3) has a length greater than the length of the guide catheter (4), said length being not greater than 150 cm, preferably not greater than 140 cm, again more preferably not exceeding 120 cm. 5. Device (1) according to any one of the preceding claims, said conical filter (2) comprising a filter mesh and a support ring which defines said end? open distal (6), wherein said filter mesh comprises a plurality? of openings having a diameter such as to block emboli and micro-emboli between 120 ?m and 200 ?m, preferably between 140 ?m and 160 ?m. 6. Device (1) according to claim 5, wherein said support ring ? made of an elastically recoverable material, preferably ? made in Nitinol. A kit comprising the embolic protection device (1) according to any one of the preceding claims and a transseptal puncture device, wherein said transseptal puncture device comprises a needle configured to puncture the interatrial septum, a dilator, and a guide catheter for said needle. 8. A kit according to claim 7 wherein said transseptal puncture device needle has a curvature at the tip. configured to puncture the interatrial septum, said curvature defining an angle preferably between 30? and 60?, more? preferably around 50?. The kit according to claim 7 or 8, wherein said transseptal puncture device needle has a length of between 50 cm and 110 cm, and/or said transseptal puncture device dilator has a length of between 60 and 70 cm, and/or said guide catheter of the transseptal puncture device has a length between 60 and 70 cm. The kit according to any one of claims 7 to 9, wherein said transseptal puncture device dilator has an outside diameter of between 8 and 9 French, and/or said transseptal puncture device guide catheter has a external diameter between 8 and 9 French.