WO2022254008A1

WO2022254008A1 - Intervention device for transcatheter cardiovascular surgery

Info

Publication number: WO2022254008A1
Application number: PCT/EP2022/065192
Authority: WO
Inventors: Marco VOLA
Original assignee: Hospices Civils De Lyon; Université Claude Bernard Lyon 1
Priority date: 2021-06-04
Filing date: 2022-06-03
Publication date: 2022-12-08
Also published as: FR3123554A1; FR3123554B1

Abstract

The invention relates to an intervention device (9) for transcatheter cardiovascular surgery, comprising: - a cardiovascular ultrasound catheter (1) having a first elongate body (10) provided with a proximal end (11), said ultrasound catheter comprising an acoustic transducer (12) at its proximal end and a connection cable (13) extending within the first elongate body; - a surgical intervention tool (2) having a second elongate body (20), a surgical intervention head (21) positioned in proximity to the acoustic transducer (12) of the ultrasound catheter; - a guide catheter (4) having a sheath (40) in which the first and second elongate bodies are housed and rigidly connected, the surgical intervention head (21) and the acoustic transducer (12) protruding from the sheath of the guide catheter, said sheath having a deflection of at least 200 mm when a transverse force of 1N is applied to one end, with the other end rigidly fixed.

Description

Title of the invention: Interventional device for transcatheter cardiovascular surgery

The invention relates to intervention equipment for interventional cardiology and transcatheter surgery, and in particular equipment used for cardiovascular interventions assisted by an ultrasound imaging device.

[0002] Interventional cardiology and transcatheter surgery have made impressive progress, further aided by the appearance of new tools. Such tools make it possible in particular to place intracardiac devices anchored by screws, staples or systems for fixing valve leaflets by clips or other systems. In addition, ultrasound tools through the esophagus have been developed to facilitate the vision of the adjacent heart chambers as well as to visualize surgical intervention tools inserted inside the heart chambers. To further promote vision of the operating area, cardiovascular ultrasound catheters to be inserted this time into the heart, with an even closer and more detailed vision, have been developed. Documents US 2009/0088648 A1, WO 99/59663 A1 and US 2009/0093726 A1 provide examples of catheter embodiments. Such an ultrasound catheter has an elongated body, at the end of which an acoustic transducer is attached. Such an ultrasound catheter can thus be introduced into the patient's heart to promote vision of the operating area during the intervention by the practitioner.

[0003] However, the vision of the operating area still proves to be insufficient to allow the operator to correctly view certain details of the intervention. It sometimes proves difficult to have a precise and constant view of a simultaneous cross-section of the tool and the tissues on which the tool operates. The quality of vision of the operative area is also strongly dependent on the placement of the ultrasound catheter in relation to the tissues targeted by the transcatheter intervention.

The invention aims to solve one or more of these drawbacks. The invention thus relates to an intervention device for transcatheter cardiovascular surgery, as defined in appended claim 1. The invention also relates to the variants of the dependent claims. Those skilled in the art will understand that each of the characteristics of the variants of the dependent claims and of the description can be combined independently with the characteristics of claim 1, without however constituting an intermediate generalization.

The invention further relates to a surgical intervention kit, as defined in the appended claims.

The invention further relates to a method of preparing an interventional device for transcatheter cardiovascular surgery, as defined in the appended claims.

Other characteristics and advantages of the invention will emerge clearly from the description given of it below, by way of indication and in no way limiting, with reference to the appended drawings, in which:

[0009] [Fig.1] is a side sectional view of an intervention device for transcatheter cardiovascular surgery according to a first embodiment of the invention;

[0010] [Fig.2] is a cross-sectional view of the device of Figure 1;

[0011] [Fig.3] is a side sectional view of an intervention device for transcatheter cardiovascular surgery according to a second embodiment of the invention;

[0012] [Fig.4] is a cross-sectional view of the device of Figure 3;

[0013] [Fig.5] is a cross-sectional view of a sheath variant of a guiding catheter;

[0014] [Fig.6] is a cross-sectional view of another sheath variant of a guide catheter;

[0015] [Fig.7] is a side sectional view of an intervention device for transcatheter cardiovascular surgery according to a third embodiment of the invention;

[0016] [Fig.8] is a cross-sectional view of the device of Figure 7; [0017] [Fig.9] is a side sectional view of an intervention device for transcatheter cardiovascular surgery according to a fourth embodiment of the invention;

[0018] [Fig.10] is a side sectional view of a manipulation end of an example of a guiding catheter implemented according to the invention;

[0019] [Fig.11] is a side sectional view of an intervention device for transcatheter cardiovascular surgery according to a fifth embodiment of the invention;

[0020] [Fig.12] is a cross-sectional view of the device of Figure 11;

[0021] [Fig.13] is a side view of another example of a surgical intervention tool associated with a guiding catheter;

[0022] [Fig.14] is a side view of another example of a surgical intervention tool associated with a guiding catheter.

The invention relates to an intervention device 9 for transcatheter cardio vascular surgery. Figures 1 and 2 are sectional views of an intervention device 9 according to a first embodiment of the invention. The intervention device 9 comprises a cardiovascular ultrasound catheter 1, a surgical intervention tool 2 and a guide catheter 4.

[0024] The cardiovascular ultrasound catheter 1 comprises in known manner an elongated body 10 provided with a proximal end 11. The elongated body 10 may typically have a diameter of less than 2 mm, to facilitate its transcatheter insertion into the a patient's heart. The ultrasound catheter 1 comprises in a manner known per se an acoustic transducer 12 at its proximal end 11. The ultrasound catheter 1 also comprises a connection cable 13 extending into the elongated body 10. The connection cable 13 makes it possible to supply the acoustic transducer 12 to generate sound signals. The connection cable 13 also makes it possible to recover signals from the acoustic transducer 12, in a manner known per se. The connection cable 13 is housed in the elongated body 10 to ensure its protection. [0025] The surgical intervention tool 2 comprises an elongated body 20 and a surgical intervention head 21. The surgical intervention head 21 is fixed to one end of the elongated body 20 and positioned close to the acoustic transducer 12 of the ultrasound catheter 1. The surgical intervention head 21 illustrated here corresponds to a stapling forceps, intended for example to staple two edges of a mitral valve or other heart valves.

The guide catheter 4 comprises a sheath 40 in which the elongated bodies 10 and 20 are housed and secured. The surgical intervention head 21 and the acoustic transducer 12 project from the sheath 40 of the guiding catheter 4. This allows both to have a range of movement for the surgical intervention head 21 and to dispose a good imaging position for the ultrasound catheter 1. The bodies 10 and 20 housed in the sheath 40 have the same curvature and a calibrated spacing. Such an intervention device 9 makes it possible to best position the ultrasound catheter 1 with respect to the surgical intervention tool 2, in order to have a minimum of movement between the two and in order to have an optimal vision. the position of the surgical intervention tool 2 and the cardiac tissues on which the surgical intervention tool 2 must intervene. This stability proves to be essential for the quality of the image when the end of the intervention device 9 is introduced into the heart which is mobile during the intervention. The image provided by the ultrasound catheter 1 is thus particularly stable and clear, and favors for example the vision of overlapping lengths between the surgical intervention tool 2 and the cardiac tissues, or even the implantation length of a screw in fabrics. In the example illustrated in Figures 1 and 2, the sheath 40 is made of a flexible synthetic material (for example silicone, polyurethane or polytetrafluoroethylene), to promote its bending and its movement in the patient's heart. It is for example possible to envisage that the sheath 40 housing the bodies 10 and 20 be dimensioned to present a deflection of at least 200mm during the application of a transverse force of 1 N at one of its ends with embedding of its other end. .

The sheath 40 here comprises emerging galleries, through which the bodies 10 and 20 pass. Most of the length of the bodies 10 and 20 is thus housed in the galleries of the sheath 40. The bodies 10 and 20 can be introduced into the galleries of the sheath 40 by one end of the sheath 40. The emerging galleries extend in parallel along the sheath 40.

Advantageously, the body 10 of the ultrasound catheter 1 or the body 20 of the surgical intervention tool 2 is slidably mounted along said sheath 40, in order to promote optimal positioning of the ultrasound catheter 1 or of surgical intervention tool 2 in the heart. For this purpose, a clearance can be provided between the bodies 10 and 20 with respect to their respective galleries. A sliding drive mechanism for the bodies 10 and 20 can be made at a distal end of the guide catheter 4.

Advantageously, the intervention device 9 has a body 10 or a body 20 mounted for rotation about its axis inside the sheath 40, in order to be able to modify the intervention position or an adaptation of the area viewed. For this purpose, a clearance can be provided between the bodies 10 and 20 with respect to their respective galleries. A mechanism for pivoting the bodies 10 and 20 can be provided at a distal end of the guiding catheter 4.

The acoustic transducer 12 can typically be configured for viewing a two-dimensional or three-dimensional image of its environment. Advantageously, the end of the ultrasound catheter 1 is mobile, so as to be able to position the transducer 12 in a desired position. The end of the ultrasound catheter 1 can for example be bent in different orientations. The transducer 12 is therefore advantageously movable relative to the part of the body 10 housed inside the sheath 40. Such a configuration is for example illustrated in the embodiment of FIG. 9. In this embodiment, the spacing (illustrated by the double arrow) between the ultrasound catheter 1 and the surgical intervention tool 2 is increased compared to the first embodiment, in order to allow clearance for the end of the catheter of echography 1. It is also possible to envisage a surgical intervention tool 2 whose end is mobile, so as to be able to flex or move the latter in several orientations. Figures 3 and 4 are sectional views of an intervention device 9 according to a second embodiment of the invention. The device 9 of the second embodiment is similar to that of the first embodiment, apart from the following technical characteristics.

This device 9 comprises another cardiovascular ultrasound catheter 3. This ultrasound catheter 3 comprises an elongated body 30 provided with a proximal end 31 and an acoustic transducer 32 at its proximal end 31. The acoustic transducer 32 projects from sheath 40 and positioned close to surgical head 21. A connector cable 33 extends into third elongated body 30. Body 30 is housed in sheath 40 of the guide catheter 4. The guide catheter 4 comprises a dedicated through gallery for this purpose. The guide catheter 4 thus makes it possible to secure the bodies 10, 20 and 30. By providing another ultrasound catheter 3, several different images of the operating field can be obtained.

In this example, in order to be able to clearly view the surgical head 21 according to several shots, the bodies 10 and 30 are positioned on either side of the body 20. In practice, the acoustic transducers 12 and 32 are positioned on either side of the surgical head 21.

In the above examples, the intervention device 9 has been presented in the form of an assembled assembly. It is also possible to envisage supplying the intervention device 9 in the form of a surgical intervention kit, combining:

-a cardiovascular ultrasound catheter 1 as described previously;

a transcatheter cardiovascular surgery tool 2 as previously described; -a guide catheter 4 as previously described. The various components of the kit can be assembled by introducing the bodies 10 and 20 into the sheath 40, in order to prepare the intervention device 9 ready for use.

[0037] Figure 5 is a cross-sectional view of a sheath variant 40 of a guide catheter 4. The sheath 40 includes a central part 48. Emerging galleries 41 and 42 are made in the central part 48. The galleries openings 41 and 42 communicate with the periphery of the central part 48 via grooves 43 and 44 respectively. The grooves 43 and 44 make it possible to laterally introduce the bodies 10 and 20 respectively. The sheath 40 also comprises an outer part 47. The outer part 47 forms a sleeve surrounding the central part 48. The outer part 47 thus makes it possible to maintain the bodies 10 and 20 in the galleries 41 and 42 of the sheath 40. The part external may for example be formed of elastomer and extend over at least the major part of the sheath 40

[0038] Figure 6 is a cross-sectional view of a sheath variant 40 of a guide catheter 4. Through galleries 41 and 42 are formed in the sheath 40. The gallery 41 communicates with the periphery of the sheath via a groove 43. The gallery 42 communicates with the gallery 41 via a groove 42. Provision can be made for the sheath 40 to be elastically deformable to allow the introduction of the bodies 10 and 20 into the galleries 41 and 42, then present two lips which come together to close the groove 43.

Figures 7 and 8 are sectional views of an intervention device 9 according to another embodiment of the invention. The device 9 of FIG. 7 is similar to that of the first embodiment, apart from the following technical characteristics. The sheath 40 comprises an intermediate sheath 45 housed in the emerging gallery 41. The intermediate sheath 45 is slidably mounted in the sheath 40. The body 10 is housed in the intermediate sheath 45 and is secured to it. Such a configuration makes it possible, for example, to advance the ultrasound catheter 1 very far cantilevered relative to the sheath 40. The intermediate sheath 45 makes it possible, for example, to stiffen the cantilevered part of the ultrasound catheter 1, to ensure accurate placement. Thus, such a configuration makes it possible to bring the transducer 12 as close as possible to the area of intervention, in a location that the sheath 40 could not reach due to its size. For example, there may be cases where the sheath 40 could not pass, for example through the mitral valve.

Figure 10 is a side sectional view of a handling end of an example of guide catheter 4 implemented according to the invention. This manipulation end comprises a housing 49 in which the distal end of the sheath 40 is embedded. Two introduction guides 61 and 62 are embedded in the housing 49 opposite the galleries 41 and 42. The introduction guides 61 and 62 have bores 69 and 60, intended to be crossed respectively by the catheter of echography 1 and by the surgical intervention tool 2. The bores 69 and 60 open into the housing 49, opposite the galleries 41 and 42. The ends 411 and 421 of the galleries 41 and 42 are flared, in order to facilitate the insertion of the ultrasound catheter 1 and of the surgical intervention tool 2 in the galleries 41 and 42. In a manner known per se, the introduction guides 61 and 62 respectively have side ducts 63 and 64 to be able to carry out a purge. In a manner known per se, the introduction guides 61 and 62 respectively comprise clamping knobs 65 and 66. The clamping knobs 65 and 66 make it possible to respectively immobilize the ultrasound catheter 1 or the surgical intervention tool 2 in place. Provision can be made for the ultrasound catheter 1 or the surgical intervention tool 2 to be able to be moved or manipulated via suitable drive controls.

[0041] Figures 11 and 12 are sectional views of an intervention device 9 according to another embodiment of the invention. The device 9 of FIG. 11 is similar to that of the first embodiment, apart from the following technical characteristics. The guiding catheter 4 includes a mechanism for moving the end of the sheath 40, in order to be able to move all the protruding elements at its end. In the example illustrated, the displacement mechanism includes cables 46 stressing the end of the sheath 40, for example in traction, in order to induce its bending in a controlled manner. The cables 46 are for example housed in the sheath 40 and exert a force on the end of the sheath 40. Such a mechanism makes it possible to apply a simultaneous and coordinated movement of the ultrasound transducer 12 and of the surgical intervention head. 21.

Advantageously, the ultrasound catheter 1 includes radiopaque markers. It is for example possible to position radiopaque markers at regular intervals along the body 10 of the ultrasound catheter 1. Such radiopaque markers can for example take the form of rings surrounding the body 10 of the catheter 1. Such markers typically allow to determine the length of the catheter 1 introduced into the heart by means of another radiation imaging device. The ultrasound catheter 1 may include an ultrasound marker, to allow the ultrasound catheter 1 to be located in the heart. An ultrasound marker can take the form of a metal ring attached to the end 11 of the ultrasound catheter 1, which constitutes a reference position.

[0043] Figure 13 schematically illustrates a surgical intervention tool 2 provided with another surgical intervention head 22, introduced into the guide catheter 4. The surgical intervention head 22 is intended to anchor artificial cords 23 , for example in a mitral pillar or in valve tissue. Such artificial cords 23 can be used in known manner to reduce problems of mitral insufficiency.

[0044] Figure 14 schematically illustrates a surgical intervention tool 2 provided with another surgical intervention head 24, introduced into the guide catheter 4. The surgical intervention head 24 is intended to anchor a valve ring 25 via screws 26 in a tissue 8 of a patient. Such a valve ring 25 is for example intended to be contracted via a traction thread 27, in order to tighten the section of the mitral duct for example. The tool 2 here comprises a screwing head 28, which makes it possible to screw screws 26 (or other anchoring systems such as coils or staples) into different locations of the fabric 8, in order to secure the ring 25 in several points, for example distributed around the mitral valve.

Claims

[Claim 1] Intervention device (9) for transcatheter cardiovascular surgery, comprising:

- a cardiovascular ultrasound catheter (1) comprising a first elongated body (10) provided with a proximal end (11), the ultrasound catheter (1) comprising an acoustic transducer (12) at its end proximal and a connection cable (13) extending in the first elongated body;

- a surgical intervention tool (2) comprising a second elongated body (20), a surgical intervention head (21) positioned close to the acoustic transducer (12) of the ultrasound catheter;

- a guide catheter (4) comprising a sheath (40) in which the first and second elongated bodies are housed and secured, the surgical intervention head (21) and the acoustic transducer (12) projecting with respect to the guiding catheter sheath; characterized in that said sheath housing said first body and said second body has a deflection of at least 200mm when applying a transverse force of 1 N at one of its ends with embedding of its other end.

[Claim 2] A transcatheter cardiovascular surgery intervention device (9) according to claim 1, wherein the first body (10) or the second body (20) is slidably mounted along said sheath (40).

[Claim 3] Intervention device for transcatheter cardiovascular surgery (9) according to claim 1 or 2, in which the first body (10) or the second body (20) is rotatably mounted about its axis at the interior of said sheath (40).

[Claim 4] A transcatheter cardiovascular surgery interventional device (9) according to any preceding claim, wherein the transducer (12) of the ultrasound catheter is movable relative to the portion of the first body housed in the sheath (40) of the guiding catheter (4).

[Claim 5] Interventional device for transcatheter cardiovascular surgery (9) according to any one of the preceding claims, wherein the acoustic transducer (12) is configured for viewing a two-dimensional or three-dimensional image of its surroundings.

[Claim 6] Interventional device for transcatheter cardiovascular surgery (9) according to any one of the preceding claims: - further comprising another cardiovascular ultrasound catheter (3) comprising a third elongated body (30) provided with a proximal end, the other catheter including another acoustic transducer (32) at its proximal end and a connector cable extending into the third elongated body; -in which the first to third elongated bodies are housed and secured in the sheath of the guiding catheter, the other acoustic transducer projecting with respect to the sheath of the guiding catheter.

[Claim 7] An interventional device for transcatheter cardiovascular surgery according to claim 6, in which the first and third bodies are positioned on opposite sides of the second body.

[Claim 8] Intervention device for transcatheter cardiovascular surgery according to any one of the preceding claims, in which the ultrasound catheter (1) is integral with an intermediate sheath (45) sliding with respect to the sheath (40) of the guide catheter (4).

[Claim 9] Interventional device for transcatheter cardiovascular surgery according to any one of the preceding claims, in which the guide catheter (4) comprises a mechanism for moving one end of the sheath (40) according to a direction perpendicular to the orientation of the first and second bodies (10, 20) in the sheath (40). [Claim 10] A transcatheter cardiovascular surgery intervention device according to any preceding claim, wherein said cardiovascular ultrasound catheter (1) has radiopaque markers at regular intervals along the first body.

(10).

[Claim 11] A transcatheter cardiovascular surgery intervention device according to any preceding claim, wherein said cardiovascular ultrasound catheter (1) has an ultrasound marker at its proximal end ( 11 ). [Claim 12] Surgical intervention kit, characterized in that it comprises:

-a cardiovascular ultrasound catheter (1) comprising a first elongated body (10) provided with a proximal end (11), the ultrasound catheter comprising an acoustic transducer

(12) at its proximal end and a connecting cable (13) extending into the first elongated body;

- a transcatheter cardiovascular surgery tool (2) comprising a second elongated body (20) and a surgical intervention head (21) positioned at one end of the second elongated body;

-a guide catheter (4) comprising a sheath provided with first and second through galleries (41, 42), configured to accommodate respectively the first body and the second body, said sheath having a deflection of at least 200mm during application of a transverse force of 1 N at one of its ends with embedding of its other end.

[Claim 13] A method of preparing an interventional device for transcatheter cardiovascular surgery, comprising the steps of: - providing a cardiovascular ultrasound catheter (1) comprising a first elongated body (10) provided with a proximal end (11), the catheter comprising an acoustic transducer (12) at its proximal end (11) and a connecting cable (13) extending into the elongate body;

- supply of a surgical intervention tool (2) comprising a second elongated body (20) and a surgical intervention head (21) positioned at one end of the second body;

- placing the first elongated body of the ultrasound catheter and the second elongated body of the surgical intervention tool in a sheath (40) of a guiding catheter (4), the surgical intervention head and the acoustic transducer projecting from the sheath of the guide catheter such that the surgical head is positioned close to the acoustic transducer (12) of the ultrasound catheter, said sheath housing said first body and said second body having a deflection of at least 200mm when applying a transverse force of 1 N to one of its ends with embedding of its other end.