GUIDE DEVICE FOR INSERTING AT LEAST ONE SURGICAL INSTRUMENT INSIDE A BODY CAVITY

A guide device for inserting a surgical instrument inside a body cavity comprises a guide body, a stabilisation opening and a stabilizing element which can be slidingly engaged inside of the guide body to come out from the latter through the stabilisation opening. In particular, the guide body comprises a deformable portion suitable to pass from a concave configuration, bending towards the inside to house at least partially therein the stabilizing element, to a convex configuration, bending towards the outside of the guide body restoring the cross-section of the inner lumen, and vice versa. The guide body is therefore able to shrink in diameter during the passage inside an introducer catheter and to reacquire the nominal diameter at the operative level.

The present invention relates to a guide device for inserting at least one surgical instrument inside a body cavity. This guide device is particularly suitable for inserting a guidewire at a bifurcation of a vascular cavity.

The present invention can be used in the medical surgical field, in particular for minimally invasive surgery, such as endovascular angioplasty in which the action spaces are significantly reduced and reaching the target area requires high sensitivity of manoeuvring by the surgeon.

The prior art document EP2020899B1 to Coppi describes a device for inserting a guidewire at a bifurcation of a vascular cavity. This known device comprises an elongated and flexible hollow body with a distal directing end open to allow both the passage of at least one guidewire designed to move the device itself inside the vascular cavities, and one or more endovascular surgical instruments for the execution of the surgical intervention. In order to allow a better movement of the hollow body along the predetermined feed path, especially at bifurcations and/or marked branches of the vascular cavities, the advancement of the body is assisted by the aid of a stabilizing element which, suitably inserted therein, comes out through a special lateral stabilisation opening.

Although known guide devices allow reaching the pathology to be treated, the Applicant has found that they are not however free from some drawbacks, mainly in relation to the introduction step inside the patient's body through appropriate introducer catheters.

The insertion of the guide device into a patient's body requires the use of introducer catheters. In the particular case of the known device of EP2020899B1, the body of the guide device and the stabilizing element must pass concurrently side by side in the introducer catheter, while emerging from the lateral stabilisation opening, aligned side by side. That is to say, the introducer catheter must be provided with an inner lumen capable of accommodating the body of the guide device and the stabilizing element aligned side by side.

The Applicant has therefore found that in order to be able to insert this type of known device inside the patient's body, it is necessary to use a high-diameter introducer catheter, for example 9 French (i.e. 3 mm outer diameter). This type of introducer catheter, usable for vascular access of the femoral type, is not suitable for an axillary and brachial vascular access, or for a radial access in which, since the vascular cavity is small, an insertion hole of reduced size is required.

Moreover, considering that the hole in the wall of the artery or vein and on the skin is compressed by a healthcare operator to obtain complete closure of the access, or in the more complex cases is closed by a mechanical device, the larger the size of the insertion hole for vascular access, the more complex and long is the procedure for closing this hole at the end of the angioplasty intervention, with consequent greater complications.

The object of the present invention is to provide a guide device for introducing at least one surgical instrument into a body cavity, which simplifies the introduction of the device into the patient's body, and in particular requiring use of smaller introducer catheters.

Further features and advantages will become apparent from the detailed description of a guide device for inserting at least one surgical instrument inside a body cavity, in particular a vascular cavity, as claimed below.

With reference to the aforementioned figures, reference numeral1indicates as a whole a guide device for inserting at least one surgical instrument (not illustrated, being known) inside one or more body cavities2, according to the present invention.

As shown in the accompanying figures, the guide device1comprises at least one substantially hollow and flexible guide body3, extending along a preferential development direction “X”.

The guide body3has an open directing end8which extends transversely to the preferential development direction “X” according to a curvilinear direction. The directing end8is therefore provided with a distal opening85.

FIGS. 4 to 6show some embodiment examples of the curvilinear direction of the directing end8of the guide device.

FIG. 4shows a directing end8comprising a first bend83, followed by a second bend84. Preferably, the first bend83is substantially 180°, and the second bend84is in the opposite direction with respect to the first bend83.

FIG. 5shows a directing end8comprising only a first bend83, substantially of 180°.

FIG. 6shows a directing end8comprising only a first partial bend83, for example substantially 45°.

The guide body3is provided with an inner lumen13a,with a substantially circular cross-section, for the sliding of a guide element9and/or a stabilizing element12and/or at least a surgical instrument intended for the intervention to be carried out.

As shown inFIGS. 2 and 14, the device1comprises at least one guide element9, of an elongated and flexible conformation, slidingly engageable inside the guide body itself to come out from the directing end8, and particularly through the distal opening85, and reach the second cavity2b.

Advantageously, the guide device1comprises stabilisation means10associated with the guide body3, designed to control the guide body3itself to improve its progress inside the cavity2a,facilitating the positioning of the directing end8with respect to the second cavity2b.

The stabilisation means10preferably comprise at least one stabilisation opening11formed through the guide body3and at least one stabilizing element12of elongated conformation (preferably over 220 cm), preferably threadlike and flexible, slidingly engageable inside the guide body3in which it is introduced from the outside in the proximal direction through the stabilisation opening11to come out from the proximal end. This insertion manoeuvre is obviously carried out when the catheter guiding body is external to the body.

Preferably, the stabilisation opening11, i.e. the exit point of the stabilizing element, is preferably positioned at the base of the catheter bend.

The stabilizing element12has transversal dimensions smaller than the dimensions of the stabilisation opening11to easily pass through the latter.

Preferably, the stabilizing element12has a greater structural rigidity than the structural stiffness of the guide element9such that its sliding inside the guide body3still determines its exit through the stabilisation opening11.

To this end, it is possible to provide that the stabilizing element12has the transversal dimensions of a common metal guide (0.035 inches, 0.889 mm).

The stabilisation opening11is preferably arranged between the directing end8and suitable manoeuvring means14(FIG. 1) located on the opposite side with respect to the directing end8and designed to move the guide device1.

Advantageously, the stabilisation opening11is located along the guide body3according to a position substantially aligned with the preferential development direction “X” and substantially tangential to the curvilinear development direction of the directing end8.

Preferably, the stabilisation opening11is positioned just upstream of the beginning of the first bend83of the guide body3.

In use, as shown inFIG. 3, when the guide body3is at a marked change in direction, i.e. when the guide body must pass from a first cavity2ato a second cavity2btransverse to the first cavity2a,the guide body3is advanced along the stabilizing element12, which is inserted inside the guide body3by the proximal portion and which protrudes at least by the distal portion through the stabilisation opening11and is positioned so as to engage the first cavity2a.

The stabilizing element12constitutes an extension of the guide body3along the first cavity2a,providing the function of rotation pin of the guide body3: the guide body3can thus be rotated around the stabilizing element12so as to allow a correct and controlled alignment of the directing end8with the second cavity2b.

The sliding element9can thus be pushed out of the distal opening85of the guide body3when the directing end8is at the second cavity2b.The guide element9is then inserted into the second cavity2btravelling along at least a significant length thereof (FIG. 3), having the solid support of the guide body3determined by the stabilizing element12.

As shown inFIG. 1, when the guide device1is used for endovascular procedures, such as angioplasty, stent applications and the like, the guide body3together with the stabilizing element12is inserted into the patient's body4through an introducer catheter9, such as that shown inFIG. 7.

In particular, the guide device1can be inserted into the body4of a patient through an opening5, formed at an area6identified as an entrance area. In some types of endovascular interventions, the entrance area6corresponds to one of the lower limbs7of the patient's body4to access, as shown inFIG. 1, a corresponding femoral artery7a.In other cases, the entrance area6corresponds to one of the upper limbs, for an axillary, brachial or radial vascular access.

The introducer catheter9comprises a proximal portion92, intended to remain outside the patient's body, and an introducer body91intended to be inserted at least partially inside a body cavity2.

The introducer body91is substantially hollow and provided with a channel93with a substantially circular cross-section, for the sliding of the guide device1, or of the guide body3and of the stabilizing element12.

The portion of the guide body3extending from the stabilisation opening11and towards the distal end being defined as flexible tip81, this flexible tip81may coincide totally or only partially with the directing end8.

Advantageously, the guide body3is at least partially compressible in a transverse direction, and in particular comprises a transversely deformable and flexible portion.

Advantageously, the guide body3comprises, at least at the flexible tip81, a deformable portion35, i.e. the guide body3is at least partially compressible in a transverse direction.

The deformable portion35is adapted to take a concave configuration, that is, to fold towards the inside of the guide body3(reducing the section of the inner lumen13a), to receive the stabilizing element12, as shown inFIG. 8, which it is therefore at least partially received within the circumference of the guide body3.

The deformable portion35is adapted to pass from a concave configuration to a convex configuration, or to fold outwardly of the guide body3(restoring the circular section of the inner lumen13a), as shown inFIG. 9.

The deformable portion35is placed along the guide body3just after the stabilisation opening11, on the same side as the stabilisation opening11.

For inserting the guide device1inside the patient's body, the guide body3and the stabilizing element12are inserted into the channel93of the introducer91.

As shown inFIG. 11, inside the introducer91, the guide body3and the stabilizing element12are side by side. Advantageously, in order to reduce the overall section of the guide device1, the deformable portion35takes a concave configuration, as shown inFIGS. 8 and 11to accommodate the stabilizing element12, which is partially received within the circumference of the guide body3. Such a technical solution allows using an introducer catheter91of reduced size compared to known guide devices.

As soon as the guide body3comes out of the introducer91, the deformable portion35takes, or returns to, a convex configuration, as shown inFIGS. 9 and 12, restoring the circular section of the inner lumen13aof the guide body3.

Such a technical solution allows using an introducer catheter91of reduced dimensions without the need to reduce the circular section of the guide body3.

As can be seen inFIG. 8andFIG. 11, the stabilizing element12presses against the deformable portion35to make it convex by reducing the section of the inner lumen13a,and is partially received within the circumference of the guide body3at the directing end8. Moreover, the overall size given by the sum of the outer diameter of the stabilizing element12and of the directing end8, by the stabilisation opening11towards the distal end of the guide body3, is substantially the same given by the outer diameter of the proximal part of the guide body3, thus facilitating the passage of the guide device1into the introducer catheters91.

The deformable portion35of the guide body3can be obtained in various ways.

In an embodiment example, at least the deformable portion35is made of a flexible polymeric material, for example of biocompatible rubber.

In a further embodiment example, shown inFIG. 15, the deformable portion35is obtained by thinning the wall of the guide body3.

In yet another further embodiment example, the wall of the guide body3includes a reinforcing armour17embedded therein.

In one variant, the reinforcing armour17extends only partially along the circumference of the guide body3. In this example, shown inFIG. 13, the deformable portion35is obtained at the portion of the part, or circumference, without reinforcing armour. The reinforcing armour17comprises, for example (seeFIG. 14) a longitudinal element32which connects pairs of ribs to each other. The free ends48of the same pairs of ribs40are separate from each other and identify at least one discontinuity52of the same ribs40, said discontinuity52being positioned at and forming the deformable portion35.

In a different variant, the reinforcing armour17extends over the entire circumference of the guide body3. In this example, the reinforcing armour17comprises a main portion and a flexible shape-memory portion. In this embodiment, the deformable portion35is obtained at the flexible portion of the reinforcing armour17.

For example, the reinforcing armour core is made of nitinol, or steel, or a moulded polymeric material or a metal or polymer material obtained by laser moulding.

In the embodiment inFIG. 16, at least one traction cable36is housed in the inner lumen13aof the guide body3. At least a portion of the traction cable36runs internally through a portion of the directing end8, following the inner bend thereof, so as to come out of a distal hole76, formed in the wall of the directing end8, and go back into the guide body3through a proximal hole80, formed in the guide body3, facing the distal hole76so as to subtend the arc formed by the directing end8.

Preferably, the guide element9and the stabilizing element12can cooperate with the traction cable36in order to control with extreme precision the exact bend of the directing end8. In fact, if on the one hand the guide element9and the stabilizing element12tend to straighten the distal end or tip of the catheter, on the other hand, by operating appropriately on the traction cable36it is possible to contrast said straightening and firmly maintain the exact bend imposed by the surgeon during the intervention. In any case, it will always be possible to completely release the inner lumen13aof the guide body3by pulling the traction cable36and/or the stabilizing element12and/or the guide element9according to the specific and contingent needs of the surgeon.

Advantageously, the guide device of the present invention solves the problems encountered in the prior art and provides important advantages.

Firstly, the guide device1of the present invention considerably facilitates the insertion operations inside a patient's body.

In fact, in order to insert the guide device1it is also possible to use smaller introducer catheters, for example 5 French (or 1.67 mm outer diameter).

The guide device1of the present invention is suitable both for vascular access of the femoral type, and for an axial, brachial and even radial vascular access.

Moreover, being able to reduce the size of the insertion hole for vascular access, the procedure for closing such a hole at the end of the angioplasty procedure is simplified and accelerated, with consequent reduction of complications.

Moreover, the guide device1of the present invention facilitates alignment of the guide body3with respect to the transverse cavities and to the bifurcations encountered along the path towards the pathology to be treated. In particular, the presence of the stabilisation means10allows a rapid and correct alignment of the directing end8, causing a considerable reduction in the intervention times.

The present invention also relates to a guide kit for inserting at least one surgical instrument inside a body cavity (2), and in particular a vascular cavity, comprising:

a guide device1as described above;
an introducer catheter9, comprising an introducer body91substantially hollow and provided internally with a channel93for the sliding of the guide device1;
wherein, when the directing end8and the stabilizing element12are placed inside the channel93of the introducer91and the stabilizing element12comes out at least partially through the stabilisation opening11of the guide body3, the deformable portion35of the guide body3adopts the concave configuration to receive at least partially the stabilizing element12so that, at the directing end8, the guide body3and the stabilizing element12run side by side and the stabilizing element12is partially housed inside the outer circumference of the guide body3.

Moreover, when the directing end8comes out of the channel93of the introducer91, the deformable portion35of the guide body3adopts the convex configuration once again, restoring the cross-section of the inner lumen13aof the guide body3.

The present invention also relates to a guide catheter, consisting of the guide body3alone, for inserting at least one surgical instrument inside a body cavity2, and in particular a vascular cavity, said guide body3being:

substantially hollow and flexible extending in a preferential direction of extension X;
defining an open directing end8, transverse to the preferential direction of extension X;
defining an inner lumen13afor the sliding of at least one stabilizing element;
provided with at least one stabilisation opening11for the exit of said stabilizing element;
provided with a deformable portion35suitable to bend towards the inside reducing the cross-section of the inner lumen13awhen the guide body3is inserted inside an introducer, and to bend towards the outside of the guide body3restoring the cross-section of the inner lumen13awhen the guide body3comes out of the introducer, and vice versa.

Innovatively therefore, a guide device according to the present invention is provided with a guide body capable, due to a deformable portion, of reducing in diameter during the passage inside an introducer catheter and of reacquiring the nominal diameter at the operational level.

Of course, the guide device1according to the present invention lends itself to any minimally invasive surgical treatment of pathologies that also involve parts of the body other than the vascular ones, such as, for example, diseases related to the urinary, digestive, renal system and/or any other system capable of being reached by the guide device described above.