Vascular plaque treatment device

Abstract

The present invention relates to a device for treating (1) vascular plaques (32) present on a carotid artery wall (34) (30), the device comprising a housing (2) that can be closed by a lid and is intended to be positioned near a vascular plaque, said housing comprising at least one diffusion device (10) configured to diffuse a drug product (6, 7) into the vascular plaque (32) and / or into the carotid artery wall (34). Abstract figure: Figure 1

Description

Title of the invention: Device for treating vascular plaques Technical field

[0001] The present disclosure relates to a device for the therapeutic treatment of vascular plaques formed on the internal wall of a carotid artery. Prior art

[0002] A stroke is linked to a sudden stoppage of blood circulation to all or part of the brain.

[0003] The brain is irrigated by the internal carotid artery and by all the supraaortic trunks, providing the oxygen necessary for its functioning. A process known as atheroma causes thickening and hardening of the arteries by the accumulation of lipids, complex carbohydrates, blood and calcareous deposits in the internal wall of the arteries, and leads to the progressive formation of one or more atheromatous plaques. There are also other causes of vascular plaque formation. This is a process whose progression is accelerated by identified risk factors, namely high blood pressure, diabetes, obesity, smoking. The presence of atheromatous plaques thus causes a reduction in the diameter of the artery, which is called "stenosis", a disease more generally called atherosclerosis. This plaque can also be of post-radiation or post-inflammatory origin or due to a collagen disease.In all these cases there is a risk of rupture. The presence of vascular plaque (due to atheroma or other origins) can be detected by various techniques, vascular Doppler ultrasound, optical coherence tomography, computed tomography or Magnetic Resonance Imaging.

[0004] A dramatic consequence of plaque rupture at the level of the carotid or supra-aortic trunks results in the migration of certain components of the plaque into the bloodstream towards the brain, thus obstructing one of the cerebral arteries, causing an ischemic stroke. One of the other possible evolutionary risks of atheromatous plaque, which is rarer, is a rupture of the plaque which results in occlusion of the internal carotid, causing a low-flow hemodynamic stroke in the event of non-compensation of the circle of Willis. In each case, the dramatic consequences are correlated with the detachment or rupture of part or all of the plaque. The rupture of part of the plaque or the entire plaque is most often followed by a more or less calcified fibrino-cruoric embolus which can obstruct the cerebral artery.

[0005] Currently, the treatment of vascular plaques is based mainly on preventive treatment which aims to avoid the appearance of plaques and to limit the risk of complications related to atherosclerosis, by suggesting that patients adopt better hygiene and dietary habits. Drug treatment may be recommended to reduce cholesterol levels and / or regulate blood pressure.

[0006] Interventional treatments can be considered. They can be surgical or percutaneous. Surgical treatment involves opening the artery and removing the plaque along with the intima. The main disadvantage is its highly invasive nature, which requires anesthesia, with the pain and stress that can make it unsuitable for some patients. Percutaneous treatment involves inserting a catheter into the artery for the placement of a stent, a metallic structure that is in a closed state during the placement phase and deployed once inserted into the area of ​​interest so as to keep the lumen open. Stent placement can be performed with or without balloon angioplasty. The main disadvantage of angioplasty and stenting is related to the pressure exerted by the stent on the plaque, which could partially detach from the wall.In addition, the presence of the stent can affect the dynamics of blood flow. Stent placement helps neutralize plaque. However, its placement can promote plaque rupture and increase the risk of stroke.

[0007] The present disclosure proposes to overcome the aforementioned drawbacks of the prior art.

[0008] An aim of the present disclosure is to provide a device for treating vascular plaques that is as minimally invasive as possible for the patient and that is simple and easy to use by the practitioner. Another aim of the present disclosure is to treat directly and in a directed manner, the vascular plaques as well as the underlying wall in order to stabilize them to limit the risk of spontaneous rupture of plaques and formation of a blood clot, leading to a stroke. The device according to the present disclosure comprises in particular means for diffusing a medicinal product directly into the region of interest to be treated, namely the vascular plaque and / or the underlying wall.The treatment device proposed by the present disclosure makes it possible to limit the number of manipulations and simplify the surgical procedure as a whole, thus allowing a quick and simple and less invasive performance than known devices. To facilitate penetration into the skin and the carotid artery, the device further has a diffusion head having a pointed shape facilitating perforation and progression into the skin, the wall of the carotid artery and / or the vascular plaque. Summary

[0009] The present disclosure improves the situation.

[0010] A device is proposed for treating vascular plaques present on a carotid wall, said device comprising a housing which can be closed by a cover and intended to be positioned near a vascular plaque, said housing comprising at least one diffusion device configured to diffuse a medicinal product into the vascular plaque and / or into the carotid wall.

[0011] According to one embodiment, the housing comprises an outer surface covered with an adhesive layer adapted to fix the housing to the skin of a patient near a vascular plaque.

[0012] According to another embodiment, the housing is in the form of a subcutaneous implant capable of being inserted under the skin of a patient, said housing comprising an outer surface intended to be placed in contact with the external wall of the carotid artery.

[0013] According to one embodiment, the housing comprises on said outer surface in contact with the external carotid wall a diffusion layer containing a medicinal product intended to be diffused into the carotid wall. In this embodiment, the diffusion device is therefore in the form of a diffusion layer containing a medicinal product intended to be diffused into the carotid wall under the effect of direct contact between this layer and the carotid wall.

[0014] According to one embodiment, said at least one diffusion device comprises: - a reservoir to accommodate a volume of medicinal product; - a diffusion module comprising a proximal end in fluid communication with the reservoir and a distal end provided with a diffusion head, said diffusion module comprising a lumen for injecting the volume of medicinal product extending between the proximal end and the distal end; - a movement mechanism coupled to the diffusion module to move it along a longitudinal axis in the housing, between a rest position in which the diffusion module is stored in the housing and a diffusion position in which the diffusion head opens outside the housing to enter the vascular plaque to diffuse the product into the plaque or to be brought into contact with the carotid wall to diffuse the product into the wall; - an injection mechanism coupled to the reservoir configured to inject a volume of drug product into the lumen of the diffusion module to diffuse the drug product via the diffusion head.

[0015] The features set out in the following paragraphs may, optionally, be implemented, independently of one another or in combination with one another:

[0016] The diffusion module comprises a cannula capable of being moved by the movement mechanism along the longitudinal axis in the housing, the proximal end of the cannula being in fluid communication with the reservoir and the distal end of the cannula forming the diffusion head in the form of a tapered tip.

[0017] The broadcast module comprises: - an outer sleeve, the distal end of the outer sleeve being provided with a tapered distal point, - a cannula mounted coaxially in the outer sleeve, said cannula being able to be moved by the movement mechanism along the longitudinal axis in the outer sleeve, the proximal end of the cannula being in fluid communication with the reservoir and the distal end of the cannula forming the diffusion head being provided with a plurality of diffusion orifices.

[0018] According to a particularly advantageous embodiment, the treatment device comprises a first diffusion device configured to diffuse a relaxation medicinal product onto the carotid wall to reduce the rigidity of the wall and a second diffusion device configured to diffuse a homogenization product into the vascular plaque to optimize the inertia of the vascular plaque.

[0019] Preferably, the homogenization product is an alcohol solution, a surgical cement or a biological glue.

[0020] Preferably, the relaxation medicinal product is a product chosen from the following products: NO donor, vasodilator, endothelin inhibitor, phosphodiesterase inhibitor, prostaglandin and derivatives, nitroglycerin, trinitrin.

[0021] According to an exemplary embodiment, said displacement mechanism comprises an extensible connector secured to a movable part of a piezoelectric displacement support, said connector comprising a proximal end fixed to the reservoir and a distal end fixed to the proximal end of the diffusion module, the displacement support being configured to move the diffusion module forward and backward by axial extension of the connector.

[0022] According to one embodiment, the expandable connector includes a lumen allowing fluid communication between the reservoir and the diffusion module for conveying the drug product from the reservoir to the distal end of the diffusion module to allow the product to be delivered by the diffusion head.

[0023] According to an exemplary embodiment, the injection mechanism comprises a piston coupled to a piezoelectric drive mechanism configured to move the piston to exert pressure in the reservoir in order to circulate the drug product in the connector and in the diffusion module towards the diffusion head.

[0024] According to a particularly advantageous embodiment, the housing comprises a communication interface adapted to receive a set of control signals intended to control said at least one diffusion device and an energy source.

[0025] According to another aspect, there is provided a vascular plaque treatment assembly comprising a vascular plaque treatment device as defined above, an imaging system adapted to generate images of the housing positioned on the body of a patient, a control unit comprising a user interface and at least one control adapted to generate a set of control signals intended to control said at least one diffusion device, and a communication interface configured to communicate with said treatment device. Brief description of the drawings

[0026] Other characteristics, details and advantages will appear on reading the detailed description below, and on analyzing the attached drawings, in which: Fig.l

[0027] [Fig.l] [Fig.l] is a schematic representation of a vascular plaque treatment device according to one embodiment, positioned on the skin of a patient, near a carotid wall and a vascular plaque. Fig. 2

[0028] [Fig.2] [Fig.2] is a schematic representation in longitudinal section of a broadcast module according to one embodiment. Fig. 3

[0029] [Fig.3] [Fig.3] is a schematic representation in longitudinal section of a broadcast module according to another embodiment. Fig. 4

[0030] [Fig.4] [Fig.4] is a schematic representation in longitudinal section of the broadcast module of [Fig.3] in use. Fig. 5

[0031] [Fig.5] [Fig.5] is a schematic representation of a device for processing vascular plaques according to a second embodiment. Fig. 6

[0032] [Fig.6] [Fig.6] is a schematic representation of a device for processing vascular plaques according to a third embodiment. Fig. 7

[0033] [Fig.7] [Fig.7] is a schematic representation of a device for processing vascular plaques according to a fourth embodiment. Fig. 8

[0034] [Fig.8] [Fig.8] is a schematic representation of a device for processing vascular plaques according to a fifth embodiment. Fig. 9

[0035] [Fig.9] [Fig.9] is a front view showing the outer surface of the device of treatment of [Fig.8] comprising a layer of medicinal product which is intended to be placed in contact with the carotid wall. Fig. 10

[0036] [Fig. 10] [Fig. 10] is a schematic representation of a vascular plaque treatment assembly comprising a vascular plaque treatment device of [Fig.5]. Fig. 11A

[0037] [Fig. 11 A] [Fig. 11 A] shows a processing device of [Fig.5], in a phase in which the two diffusion modules are in the rest position, stored in the housing. Fig. 11B

[0038] [Fig. 1 IB] [Fig. 1 IB] shows the treatment device of [Fig. 11 A] in a phase in which the two diffusion modules are in diffusion position with the two diffusion heads opening outside the housing. Fig. 11C

[0039] [Fig. 1 IC] [Fig. 1 IC] shows the processing device of [Fig. 11 A] in a phase in which the two diffusion modules return to their rest position. Fig. 12A

[0040] [Fig.l2A] [Fig.l2A] shows a treatment device according to another embodiment in which the housing is inserted under the skin and brought into contact with the carotid wall, in a phase in which the two diffusion modules are in the rest position, stored in the housing. Fig. 12B

[0041] [Fig.l2B] [Fig.l2B] shows the treatment device in a phase in which the two diffusion modules are in diffusion position with the diffusion heads opening outside the housing. Fig. 12C

[0042] [Fig.l2C] [Fig.l2C] shows the treatment device in a phase in which the two diffusion modules return to their rest position. Description of the embodiments

[0043] In the remainder of the description, the following terms must be understood in light of their definition below:

[0044] In the context of the present invention, the term "proximal" means an end of a part of the treatment device closest to the practitioner.

[0045] The term "distal" means an end of a part of the treatment device furthest from the practitioner. In other words, the distal end of a part is the end that would be closest to a region of the patient's body to be treated, i.e., an area of ​​the carotid wall or an area of ​​the interior of the vascular plaque.

[0046] With reference to [Fig.l], a device 1 for treating vascular plaques according to one embodiment is described below.

[0047] The treatment device 1 comprises a housing 2 configured to be arranged opposite a carotid 30 or supra-aortic trunks of a patient in order to treat one or more vascular plaques 32 formed on the internal wall of the carotid 30 of a patient. For example, the treatment device can be positioned opposite the internal carotid just after the bifurcation of the common carotid.

[0048] Generally, the positioning of the treatment device can be adjusted according to clinical needs.

[0049] According to an embodiment as illustrated in [Fig.l], the housing 2 comprises an outer surface 5 provided with an adhesive layer 12 which makes it possible to stick the housing to an area of ​​the outer surface of the skin 31 of the neck, close to the carotid artery 30. The treatment device is in the form of a patch. Preferably, the material used to manufacture the housing is a flexible material, so as to be able to adapt to the curvature of the patient's outer skin.

[0050] Preferably, the adhesive layer 12 is made of any adhesive material capable of being applied directly to the skin of a human being. The adhesive material is a biocompatible adhesive material. By biocompatible material is meant any material capable of being used in or on biological tissues, without degrading the biological tissues concerned during or after contact. In the context of the invention, the biocompatible material used must in particular take into account the properties of the patient's skin. In one embodiment, the adhesive layer is made of polyurethane, acrylic, cyanoacrylate, hydrocolloid material, etc. Those skilled in the art know which biocompatible adhesive material to use depending on the total adhesive surface to be provided, the fragility of the skin of the patient for whom the treatment device is intended. Preferably, the adhesive material may comprise antimicrobial or antiseptic substances.

[0051] The treatment device 1 comprises a drug product diffusion device 10, a communication interface 3 (INT1) and an energy source 4 (BATT) which are housed inside the housing 2.

[0052] The diffusion device 10 comprises a reservoir 11 which can accommodate either a volume of relaxation medicinal product 6 or a volume of homogenization medicinal product 7, a diffusion module 40, 50, a displacement mechanism 14 coupled to the diffusion module 40, 50 and an injection mechanism 17 coupled to the reservoir 11.

[0053] In the case where the reservoir 11 is filled with a relaxation medicinal product 6, the diffusion device 10 is adapted to diffuse the relaxation medicinal product 6 directly onto the wall 34 of the carotid 30 to reduce the rigidity of the wall, thus making it possible to reduce the risk of rupture of the vascular plaque formed on the corresponding wall.

[0054] In the case where the reservoir 11 is filled with a homogenizing medicinal product 7, the diffusion device 10 is adapted to diffuse the homogenizing medicinal product 7 inside the vascular plate 32 to optimize the inertia of the vascular plate, thus also making it possible to reduce the risk of rupture of the vascular plate.

[0055] According to an exemplary embodiment as illustrated in [Fig. 1], the vascular plaque treatment device 1 comprises a single diffusion device chosen from the two diffusion devices for diffusing either the relaxation medicinal product 6 or the homogenization medicinal product 7.

[0056] According to another exemplary embodiment illustrated for example in Figures 5, 6, 7, and 8, the vascular plaque treatment device may comprise two diffusion devices. Thus, it is possible to treat both the plaque and the wall in order to be able to combine the two treatment effects. It is also possible to actuate only one of the two treatment devices according to the clinical needs of the patient.

[0057] With reference to [Fig. 2], the diffusion module 40 according to one embodiment is described. The diffusion module 40 comprises a cannula 46 which extends along a longitudinal axis 8 (AA') in the housing and is in the form of a cylinder with a right circular section. The cannula has a diameter adapted with respect to the viscosity of the product which circulates in the cannula. In general, the dimensions of the cannula 46 are adapted to the body of the patient to be treated and to the shape of the vascular plaque to be treated. In the position of use, the longitudinal axis is substantially perpendicular to the surface of the patient's skin as illustrated in [Fig. 1].

[0058] The cannula 46 comprises a proximal end 41 in fluid communication with the reservoir 11 and a distal end 42. The cannula has a generally hollow cylindrical shape with a right circular section. The distal end of the cannula comprises a diffusion head 43 intended to diffuse one of the two medicinal products. The cannula 46 comprises an injection lumen 44 which extends between the proximal end and the distal end. The diffusion head 43 is in the form of a tapered tip which has the function of facilitating the penetration of the distal end of the diffusion module when the diffusion module must pass through a biological body, for example the skin and / or the carotid wall. The cannula 46 is coupled to the displacement mechanism 14 which is configured to move it between a rest position, in in which the cannula 46 is entirely stored in the housing 2, and a diffusion position in which the diffusion head 43 projects from the housing 2 to diffuse either the relaxation medicinal product 6 onto the carotid wall 34 or the homogenization medicinal product 7 into the plate 32.

[0059] Referring to [Fig.3], a diffusion module 50 according to another embodiment is described.

[0060] The diffusion module 50 comprises an external sleeve 55 of substantially cylindrical shape with a right circular section which extends along a longitudinal axis 8 (AA') in the housing 2. The external sleeve 55 comprises a proximal end 51 and a distal end 52. The distal end 52 of the sleeve comprises a beveled tip 59. The beveled shape of the external sleeve makes it easier to insert the distal end of the diffusion module when the diffusion module must pass through a biological body, for example the skin in order to bring the diffusion head into contact with the external wall of the carotid artery. In the case of a module for diffusing a medicinal product into the volume of the atheromatous plaque, the beveled tip makes it possible to successively facilitate the penetration of the distal end of the diffusion module into the skin and then the wall of the carotid artery.

[0061] The outer sleeve 55 is hollow, and a cannula 56 extends along the longitudinal axis AA' in an internal volume of the outer sleeve 55. The cannula is in the form of a hollow cylindrical section with a right circular cross-section, concentric with the outer sleeve 55. The external diameter of the cannula is strictly less than the internal diameter of the outer sleeve, so that a movement along the axis AA' of the cannula 56 relative to the outer sleeve 55, or vice versa, is possible without friction. In the position of use, the longitudinal axis AA' 8 is substantially perpendicular to the surface of the patient's skin as illustrated in [Fig.l].

[0062] The cannula 56 comprises a proximal end in fluid communication with the reservoir 11 and a distal end. The distal end of the cannula comprises a diffusion head 53 intended to diffuse the medicinal product. The cannula 56 comprises an injection lumen 54 which extends between the proximal end and the distal end. The diffusion head 53 has a substantially rounded shape provided with a plurality of orifices 58 making it possible to diffuse a relaxation medicinal product 6 onto the external wall of the carotid or a homogenization medicinal product 7 into the plaque 32.

[0063] As in the embodiment of [Fig. 2], the diffusion module 50 of [Fig. 3] is capable of being moved by a movement mechanism 14 between a rest position in which the outer sleeve 55 and the cannula 56 are stored in the housing 2, and a diffusion position in which the distal end 52 of the diffusion module 50 projects from the housing 2 to be in position to diffuse the relaxation drug product 6 on the external wall of the carotid artery or homogenization product 7 in the plaque.

[0064] In the diffusion position, the outer sleeve has been moved back towards the proximal end of the cannula, opposite the distal end of the diffusion module. This longitudinal movement of a determined distance makes it possible to release the distal end of the cannula, i.e. the diffusion head of the cannula. The diffusion mechanism comprises locking elements (not shown) configured to lock the cannula in the diffusion position in the outer sleeve.

[0065] With reference to [Fig.4] which illustrates the diffusion module of [Fig.3] in the position for diffusing a product onto the carotid wall, the diffusion head 53 of the cannula 56 projects from the distal end of the outer sleeve 55 and is positioned in contact against the carotid wall 34 to diffuse the medicinal relaxation product 6. In another example of use of the diffusion module not illustrated, the diffusion head 53 of the cannula 56 projects from the distal end of the outer sleeve 55 and is positioned in the plate to diffuse the medicinal homogenization product 7 into the plate.

[0066] In the case where the diffusion module 40 of [Fig. 2] is used in a housing intended to be placed on an external surface of the patient's skin, when the diffusion module 40 is used to diffuse the relaxation product 6, it is the tapered tip 43 of the cannula which first comes into contact with the patient's skin 31, facilitating the penetration of the diffusion head 43 of the cannula which is then positioned in contact with the carotid wall in order to diffuse the relaxation product 6 into the carotid wall. The diffusion head 43 does not pass through the carotid wall. On the diffusion head 43, an orifice is provided. The orifice must have sufficient and suitable dimensions to allow the relaxation medicinal product 6 to pass through which flows through the injection lumen 44 of the cannula 46.

[0067] In the case where the diffusion module 40 is used to diffuse the homogenization product 7 into the plate 32, the sharp tip of the diffusion head 43 passes through the patient's skin 31, and then the carotid wall 34. The diffusion head 43 is positioned in the plate to diffuse the homogenization drug product into the plate. The movement of the diffusion module is controlled so that the diffusion head is positioned in the plate so as to diffuse the product only into the plate.

[0068] According to another embodiment as illustrated in Figures 7 and 8, the treatment device 300, 400 may also be a subcutaneous implantable device. The housing 302, 402 is for example made of a biocompatible material. The treatment device may be placed under the skin 31, near the carotid artery 30, near a vascular plaque. It is placed by the practitioner who performs a detachment under the skin for its placement in contact with the muscle under the skin.

[0069] In the case where the housing 302 of the treatment device 300 is in the form of a subcutaneous implant as illustrated in [Fig.7]. The housing 302 is therefore already in place under the skin 31. When the diffusion module 40 of [Fig.2] is used to diffuse the relaxation product 6, the diffusion head 43 of the cannula is brought into contact with the external wall 34 of the carotid to diffuse the medicinal relaxation product 6 which flows through an injection lumen 44 of the cannula 46 which extends between the proximal end and the distal end. In this example, the diffusion head 43 of the diffusion module may have a substantially conical shape with a rounded tip. The tip could have other suitable shapes depending on the dedicated use.

[0070] When the diffusion module 40 of [Fig. 3] is used to diffuse the homogenization product 7, it is the sharp tip of the diffusion head 43 which passes through the carotid wall 34, thus facilitating the penetration of the diffusion head 43 into the plaque to diffuse the homogenization drug product into the plaque.

[0071] The movement of the cannula 46 along the longitudinal axis of movement AA' is actuated by the movement mechanism 14 which is coupled to the cannula 46 between the rest position and the diffusion position.

[0072] According to one embodiment, the displacement mechanism 14 comprises an extensible connector 15 and a piezoelectric displacement support 16. The geometric axis AA' 8 or the displacement axis of the cannula 46, is that of the extensible connector 15 and the support 16. The three elements are thus aligned along the longitudinal axis AA'. The connector 15 is fixed on a movable part of the piezoelectric displacement support 16, the displacement of which makes it possible to retract or extend the extensible connector 15. The extension and retraction of the connector 15 thus causes the translational displacement of the cannula 46 and the diffusion head 43 along the axis AA'.

[0073] A wall of the housing towards which the diffusion head 43 is oriented comprises an opening 21 having a dimension adapted to allow the diffusion head 43 and possibly a portion of the cannula 46 to pass.

[0074] The piezoelectric displacement support 16 is also received in the internal housing of the housing 2 and the base of the support is secured to the bottom of the housing. The connector 15 is centered relative to the support 16.

[0075] The connector 15 includes a proximal end in fluid communication with the reservoir 11 and a distal end in fluid communication with the cannula 46. The connector 15 also includes an internal lumen. The connector 15 and the cannula 46 are aligned to form a common lumen that extends from an outlet of the reservoir to the distal end of the cannula, to allow delivery of the relaxation drug product 6 or homogenization drug product 7 from the reservoir 11 to the distal end of the cannula to be delivered by the diffusion head 43.

[0076] Advantageously, the movable part of the support 16 is controlled remotely by the practitioner so as to move the diffusion head to the desired location to diffuse the medicinal product.

[0077] In the context of diffusion of the medicinal product in the carotid wall, the mobile part of the support is controlled remotely by the practitioner so as to place the diffusion head 43 in contact with an external surface of the wall 34 of the carotid or supra-aortic trunk to diffuse the relaxation product in the wall 34. The diffusion head does not pass through the wall and sends the product only onto the carotid wall.

[0078] In the context of diffusion of the medicinal product in the plate, the movement of the cannula 46 is controlled remotely by the practitioner so as to insert the diffusion head 43 into the interior volume of the vascular plate 32 to diffuse the homogenization product into the plate 32. The diffusion head enters the plate and is positioned in the plate so that the product is diffused only into the plate.

[0079] According to one embodiment, the homogenizing medicinal product 7 is an alcohol solution, a surgical cement or a biological glue which has the effect of optimizing the inertia of the plate to limit the risk of plaque rupture. For example, PMMA (Polymethacrylate) type surgical cements, commonly used in vertebroplasty, may be cited.

[0080] Preferably, the relaxation medicinal product 6 is a product chosen from the following products: NO donor, vasodilator, endothelin inhibitor, phosphodiesterase inhibitor, prostaglandin and derivatives, nitroglycerin, trinitrin

[0081] To inject the volume of medicinal product contained in the reservoir 11 into the injection lumen of the diffusion module, the injection mechanism 17 comprises a piston 18 coupled to a piezoelectric drive mechanism 19 configured to move the piston 18 in order to exert pressure in the reservoir to circulate the product in the lumen of the connector and in that of the cannula 46 in the direction of the diffusion head 43. The pressure is adapted according to the viscosity coefficient of the product and the diameter of the cannula so that the product can circulate in the cannula and be delivered to the area to be treated by the diffusion head.

[0082] The dose of the two products is defined in advance by the practitioner according to the size and structure of the plaque to be treated.

[0083] Following treatment with the products, the patient's plaque status may be reassessed periodically, for example every three or six months.

[0084] Advantageously, during this re-evaluation period, the device of treatment is left in place. Thus, if it is decided to reprocess the plaque, it is possible to fill the reservoirs of the treatment device using a syringe by the practitioner to diffuse either the homogenization product or the relaxation product or both.

[0085] Advantageously, the diffusion orifice is centered relative to the diffusion head and the lumen of the cannula to allow, during diffusion of the medicinal product, a homogeneous distribution of the product in the desired location.

[0086] In the context of the diffusion of the relaxation product 6, the product is diffused homogeneously on the surface of the carotid wall around the contact zone.

[0087] In the context of the diffusion of the homogenization product 7, the product is diffused homogeneously in the internal volume of the vascular plaque. To do this, the size and geometric shape of the plaque to be treated are determined in advance by the practitioner before the treatment phase. Similarly, the diffusion coefficient of the plaque can be determined as a function of the viscosity coefficient of the homogenization product chosen by the practitioner. These parameters can be determined on an in vitro sample. Thus, it is possible to define the optimal location of the distal end of the tapered tip of the diffusion head 43 in the volume of the plaque as a function of the size of the plaque, the structure of the plaque and the diffusion coefficient of the plaque.

[0088] Advantageously, the vascular plaque treatment device is a stand-alone device. The device comprises an energy source 4 (BATT) which can, for example, be rechargeable by an external device, in particular by induction.

[0089] The communication interface 3 is configured to receive commands sent by a control unit arranged remotely from the treatment device to control the movement of the cannulas to the desired location and the injection of the medicinal products into the cannulas.

[0090] The communication interface 3 can be for example: - a short-range radio interface, particularly of the “Bluetooth”, “Wifi” or other type, - or a near-field communication interface, particularly of the NFC or RFID type.

[0091] In the case where the diffusion module 50 of [Fig. 3] is used in a housing intended to be placed on an external surface of the patient's skin and when the diffusion module 50 is used to diffuse the relaxation product 6, it is the beveled tip 59 of the external sleeve 55 which first comes into contact with the patient's skin 31, facilitating the penetration of the distal end of the diffusion module 50. The external sleeve was then moved back towards the proximal end of the diffusion module along the longitudinal axis by means of a displacement mechanism coupled only to the outer sleeve, allowing the diffusion head 53 to be released from the cannula to diffuse the relaxation drug product onto the carotid wall. When the diffusion module is used to diffuse the homogenization product 7, it is the beveled tip 59 of the outer sleeve 55 which successively passes through the skin and the carotid wall, facilitating the penetration of the distal end of the diffusion module 50 into the plaque. The outer sleeve was then moved back towards the proximal end of the diffusion module along the longitudinal axis, allowing the diffusion head 53 to be released from the cannula for diffusion of the homogenization product 7 into the plaque.

[0092] The diffusion module 50 can also be used in a housing in the form of a subcutaneous implant. When the diffusion module 50 is used to diffuse the relaxation product 6 into the carotid wall, the diffusion module has been moved to position the distal end of the diffusion module in contact with the carotid wall. The outer sleeve 55 has been moved back towards the proximal end of the cannula 56 along the longitudinal axis, allowing the diffusion head 53 of the cannula to be released to diffuse the medicinal relaxation product onto the wall. When the diffusion module 50 is used to diffuse the homogenization product 7, it is therefore the beveled tip 59 of the outer sleeve 55 which passes through the carotid wall facilitating the penetration of the distal end of the diffusion module 50 into the plaque.The outer sleeve was then moved back towards the proximal end of the diffusion module along the longitudinal axis, allowing the diffusion head 53 to be released from the cannula for diffusion of the homogenization product 7 into the plate.

[0093] The movement mechanism 14 for moving the diffusion module 50 is similar to that associated with the diffusion module 40 of [Fig. 2]. According to an exemplary embodiment, the cannula 56 is connected to the reservoir via the extensible connector 15. The cannula is coupled to the external sleeve which is coupled to the support 16, the movement of which allows the sleeve and the cannula to be moved.

[0094] Similarly, the injection mechanism 17 for injecting the medicinal product is similar to that associated with the diffusion module 40 of [Fig.2].

[0095] With reference to [Fig.5], the diffusion device 100 according to one embodiment is illustrated.

[0096] The diffusion device 100 comprises a housing 102 configured to be arranged opposite a carotid 30 or supra-aortic trunks of a patient in order to treat one or more vascular plaques 32 formed on the internal wall of the carotid 30 of a patient. The housing 102 comprises an outer surface 105 provided with an adhesive layer 112 which makes it possible to stick the housing 102 on an area of ​​the outer surface of the skin 31 of the neck, close to the carotid 30. The treatment device 100 comprises a first drug product diffusion device 110 and a second drug product delivery device 120, a communication interface 103 (INT1) and a power source 104 (BATT) which are housed inside the housing 102.

[0097] In the embodiment illustrated in [Fig.5], the two diffusion devices are identical and include the diffusion module 140 of [Fig.2] for diffusing the medicinal product.

[0098] The first diffusion device 110 comprises a reservoir 111 in which a volume of homogenization medicinal product 7 is received, a diffusion module 140 of [Fig.2] for diffusing the homogenization medicinal product 7, a displacement mechanism 114 coupled to the diffusion module 140 and an injection mechanism 117 coupled to the reservoir 111.

[0099] The second diffusion device 120 comprises a reservoir 121 in which a volume of relaxation drug product 6 is received, a diffusion module 140 of [Fig.2] for diffusing the relaxation drug product 6, a displacement mechanism 124 coupled to the diffusion module 140 and an injection mechanism 127 coupled to the reservoir 121.

[0100] With reference to [Fig.6], the diffusion device 200 according to another embodiment is illustrated.

[0101] The diffusion device 200 comprises a housing 202 configured to be disposed opposite a carotid 30 or supra-aortic trunks of a patient in order to treat one or more vascular plaques 32 formed on the internal wall of the carotid 30 of a patient. The housing 202 comprises an outer surface 205 provided with an adhesive layer 212 which makes it possible to stick the housing 202 to an area of ​​the outer surface of the skin 31 of the neck, near the carotid 30. The treatment device 200 comprises a first drug product diffusion device 210 and a second drug product diffusion device 220, a communication interface 203 (INT1) and a power source 204 (BATT) which are housed inside the housing 202.

[0102] In the embodiment illustrated in [Fig.6], the second diffusion device 220 comprises the diffusion module 250 of [Fig. 3] for diffusing the relaxation medicinal product 6 for example. The first diffusion device 210 comprises the diffusion module 240 of [Fig. 2] for diffusing the homogenization medicinal product 7.

[0103] The first diffusion device 210 comprises a reservoir 211 in which a volume of homogenization medicinal product 7 is received, a diffusion module 240 of [Fig.2] for diffusing the homogenization medicinal product 7, a displacement mechanism 214 coupled to the diffusion module 240 and an injection mechanism 217 coupled to the reservoir 211.

[0104] The second diffusion device 220 comprises a reservoir 221 in which a volume of relaxation drug product 6 is received, a diffusion module 250 of [Fig. 3] for diffusing the relaxation drug product 6, a displacement mechanism 224 coupled to the diffusion module 250 and an injection mechanism 227 coupled to the reservoir 221.

[0105] With reference to [Fig.7], the diffusion device 300 according to another embodiment is illustrated.

[0106] The diffusion device 300 comprises a housing 302 configured to be disposed opposite a carotid 30 or supra-aortic trunks of a patient in order to treat one or more vascular plaques 32 formed on the internal wall of the carotid 30 of a patient. The housing 302 is made of a biocompatible material and is used in the form of a subcutaneous implant to be placed under the skin. The treatment device 300 comprises a first drug product diffusion device 310 and a second drug product diffusion device 320, a communication interface 303 (INT1) and a power source 304 (BATT) which are housed inside the housing 302.

[0107] The first diffusion device 310 comprises a reservoir 311 in which a volume of homogenization medicinal product 7 is received, a diffusion module 340 of [Fig.2] for diffusing the homogenization medicinal product 7, a displacement mechanism 314 coupled to the diffusion module 340 and an injection mechanism 317 coupled to the reservoir 311.

[0108] The second diffusion device 320 comprises a reservoir 321 in which a volume of relaxation drug product 6 is received, a diffusion module 350 of [Fig. 3] for diffusing the relaxation drug product 6, a displacement mechanism 324 coupled to the diffusion module 350 and an injection mechanism 327 coupled to the reservoir 121.

[0109] With reference to [Fig.8], the diffusion device 400 according to another embodiment is illustrated.

[0110] The delivery device 400 comprises a housing 402 configured to be disposed opposite a carotid artery 30 or supra-aortic trunks of a patient in order to treat one or more vascular plaques 32 formed on the inner wall of the carotid artery 30 of a patient. The housing 402 is made of a biocompatible material and is used in the form of a subcutaneous implant to be placed under the skin.

[0111] An external surface 405 of one of the walls of the housing is covered with a layer 420 containing a relaxation medicinal product 406. When the housing is placed under the skin, the layer 420 is in direct contact with the external wall of the carotid in order to diffuse the product 406 into the carotid wall.

[0112] The processing device 400 further comprises a device for broadcasting homogenization product 410, a communication interface 303 (INT1) and a power source 304 (BATT) which are housed inside the housing 302.

[0113] In the embodiment illustrated in [Fig.7], the diffusion device 410 comprises the diffusion module 440 of [Fig.2] for diffusing the homogenization medicinal product 7.

[0114] [Fig.9] illustrates a view of the external surface of the housing 402 showing the layer 420 which contains the relaxation drug product 406. In order to allow the passage of the diffusion head of the diffusion module 440, an orifice 408 is made in the wall of the housing which is intended to be positioned in contact with the external wall of the carotid.

[0115] With reference to [Fig. 10], a processing assembly is described below.

[0116] The processing assembly may comprise one of the plate processing devices described above and illustrated in [Fig.l], 5, 6, 7 or 8.

[0117] [Fig. 10] illustrates an exemplary embodiment of the processing assembly 500 comprising a plate processing device of [Fig. 5].

[0118] The assembly further comprises an imaging system 501 (IMA), a control unit 502 (UNIT CONTROL) and a communication interface 508 (INT2).

[0119] The imaging system 501 may be an imaging system that can be used in association with the procedure of treating vascular plaques. In the context of the present invention, the imaging system is an ultrasound system adapted to take one or more ultrasound images in real time during the treatment procedure to assist in particular the practitioner in correctly positioning the distal end of the diffusion module relative to the region of interest to be treated, the images being able to be displayed on a monitor of the control unit 502 to allow the practitioner to precisely direct the diffusion head of the diffusion module.

[0120] The control unit 502 comprises a user interface 506, a first command 504 (COM1) associated with the first diffusion device 110 and a second command 505 (COM2) associated with the second diffusion device 120, allowing the practitioner to control the two diffusion devices independently of each other to activate the diffusion.

[0121] The control unit 502 may be located remotely from an operating room where the patient is located.

[0122] The controls 504, 505 are configured to actuate the first and second movement mechanisms to advance or retract the diffusion modules to diffuse the medicinal product respectively into the carotid wall and into the vascular plaque. The controls 504, 505 are also configured to actuate the product injection mechanisms. The controls may comprise, for example, one or more buttons, one or more multiple joysticks configured to control the associated module. Specifically, the joysticks are used to control the piezoelectric displacement support to retract or extend the associated connectors to move the diffusion module forward or backward between the rest position and the diffusion position.

[0123] The user interface 506 is configured to allow the practitioner to enter control instructions. The interface also includes a monitor for displaying image data, for example, ultrasound images, patient hemodynamic data (blood pressure, heart rate, etc.) and patient information (medical history, age, weight), information specific to the vascular plaque treatment method, for example, the duration of treatment, the volume of the drug product. More specifically, the interface 506 allows real-time display of images from the imaging system showing the progress and positioning of the diffusion head towards the desired location for diffusing the drug product, thereby helping the practitioner to correctly position the diffusion head during the treatment procedure.

[0124] Generally, the user interface is in communication with a set of sensors for monitoring the patient's condition, for example the patient's blood pressure, heart rate.

[0125] The control unit 502 can communicate with the components of the vascular plaque treatment device 100 via the communications interfaces 508, 103.

[0126] The communication interfaces 103, 508 can be for example: - a short-range radio interface, particularly of the “Bluetooth”, “Wifi” or other type, - or a near-field communication interface, particularly of the NFC or RFID type.

[0127] The communication interface 508 is configured to allow the control unit 502 to communicate with the vascular plaque treatment device, in particular to control the two diffusion devices 110, 120 housed in the housing, and more precisely the movement of the diffusion heads to the desired location.

[0128] A method of diffusing the relaxation drug product and the homogenization drug product using the diffusion device of [Fig. 5] will now be described using Figures 11A-1 IC.

[0129] In the example illustrated, the treatment device comprises a first diffusion device 110 of the homogenization product 7 and a second diffusion device 120 of the relaxation product 6. The associated diffusion module is for example that of [Fig.2],

[0130] In a first step E1 and as can be seen in [Fig. 1 IA], the housing 102 of the treatment device is glued to an external surface of the skin 31 of a patient, opposite a vascular plaque 32 formed on the internal wall of a carotid 30. The housing 102 is arranged so that the diffusion modules extend along a longitudinal axis perpendicular to the surface of the skin. The diffusion heads are oriented towards the skin 31. The two reservoirs are filled respectively with a relaxation product 6 and a homogenization product 7. The two diffusion modules are stored inside the housing.

[0131] In a second step E2, the displacement mechanisms are actuated and the two modules are moved longitudinally in the direction of the plate 32 and open outside the housing through the orifices provided in the wall of the housing.

[0132] According to an exemplary embodiment, the two movement mechanisms are actuated one after the other. The two cannulas are moved one after the other by the practitioner.

[0133] According to another exemplary embodiment, the two movement mechanisms can be actuated simultaneously. The two diffusion modules are then moved at the same time by the practitioner via the controls 504, 506.

[0134] According to one embodiment, the second diffusion module used is that of [Fig.2], it is the tapered tip of the cannula which pierces and passes through the patient's skin 31. The diffusion head 43 is moved to be brought into contact with the carotid wall 34 in order to diffuse the relaxation product onto the wall 34.

[0135] According to another embodiment, the second diffusion module used is that of [Fig.3], it is the beveled tip of the external sleeve which pierces and passes through the skin 31 of the patient.

[0136] According to one embodiment, the first diffusion module used is that of [Fig.2], it is the tapered tip of the cannula which pierces and passes through the skin 31 of the patient, then the carotid wall 34 to position the diffusion head in the plaque in order to diffuse the homogenization product 7 in the plaque. According to another embodiment, the first diffusion module used is that of [Fig.3], it is the beveled tip of the external sleeve which pierces and passes through the skin 31 of the patient, then the carotid wall 34 to position the diffusion head in the plaque in order to diffuse the homogenization product in the plaque.

[0137] In a third step E3, the injection mechanisms coupled to the reservoirs are actuated by the practitioner, allowing the product to flow through the cannula to the diffusion head. More precisely, the piston is pressed into the reservoir to cause the product to enter the cannula. The product flows via the diffusion head through an orifice.

[0138] According to an exemplary embodiment, the two diffusion mechanisms are actuated one after the other.

[0139] According to another embodiment, the two diffusion mechanisms can be actuated simultaneously. The two pistons are then pressed at the same time by the practitioner via commands 504, 506 in the associated reservoirs to introduce the products into the cannulas.

[0140] In a fourth step E4, when the two reservoirs are empty, the movement mechanisms are actuated again and the two diffusion modules are completely removed from the patient's body, to be stored inside the housing 102.

[0141] The removal of the diffusion modules can be carried out sequentially or simultaneously.

[0142] A method of diffusing the relaxation drug product and the homogenization drug product using the diffusion device of [Fig.7] will now be described using Figures 12A-12C.

[0143] In the example illustrated, the treatment device comprises a first diffusion device 310 of the homogenization product 7 and a second diffusion device 320 of the relaxation product 6.

[0144] In a first step E1 and as can be seen in [Fig. 12A], the housing 302 of the treatment device is implanted under the skin and positioned on an external surface of the carotid wall of a patient, opposite a vascular plaque 32 formed on the internal wall of a carotid 30. The housing 302 is arranged so that the two diffusion modules extend along a longitudinal axis perpendicular to the surface of the skin. The diffusion heads are oriented towards the skin 31. The two reservoirs are filled respectively with a relaxation product 6 and a homogenization product 7. The two diffusion modules are stored inside the housing. For example, the diffusion module of the relaxation product 6 used is that of [Fig. 3]. The diffusion module of the homogenization product 7 used is that of [Fig. 2].

[0145] In a second step E2, the displacement mechanisms are actuated and the two modules are moved longitudinally in the direction of the plate 32 and emerge outside the housing through the opening provided in the wall of the housing.

[0146] According to one embodiment, the second diffusion module 320 used is that of [Fig.3], the external sleeve has been moved back to release the rounded-end diffusion head 53 from the cannula in order to diffuse the relaxation product onto the carotid wall 34.

[0147] According to one embodiment, the first diffusion module used 310 is that of [Fig.2], it is the tapered tip of the cannula which pierces and passes through the carotid wall to position the diffusion head in the plaque in order to diffuse the homogenization product 7 in the plaque. According to another embodiment not illustrated, the first diffusion module used can be that of [Fig.3], it is the beveled tip of the external sleeve which pierces and passes through the carotid wall to position the diffusion head in the plaque in order to diffuse the product homogenization in the plate.

[0148] In a third step E3, the diffusion mechanisms coupled to the reservoirs are actuated by the practitioner, allowing the product to flow through the cannula to the diffusion head. More precisely, the piston is pressed into the reservoir to cause the product to enter the cannula. The product flows via the diffusion head through an orifice.

[0149] According to another exemplary embodiment, the two diffusion mechanisms can be actuated simultaneously. The two pistons are then pressed at the same time by the practitioner via the controls 504, 506 into the associated reservoirs to cause the products to penetrate into the cannulas.

[0150] In a fourth step E4, when the reservoirs are empty, the movement mechanisms are actuated again and the diffusion modules are completely removed from the patient's body, to be stored inside the housing.

[0151] Thanks to the diffusion devices placed near the plates, the treatment device of the present disclosure makes it possible to stabilize the plates by diffusing treatment products directly into the plates and the underlying walls.

Claims

Claims

1. Device (1) for treating vascular plaques (32) present on a wall (34) of a carotid artery (30), said device comprising a housing (2) which can be closed by a cover and intended to be positioned close to a vascular plaque (32), said housing comprising at least one diffusion device (10), said at least one diffusion device (10) comprising a reservoir (11) comprising a relaxation medicinal product (6) intended to be diffused onto the carotid artery wall (34) to reduce the rigidity of the wall or a homogenization medicinal product (7) intended to be diffused into the vascular plaque (32) to optimize the inertia of the vascular plaque.

2. A device according to claim 1, wherein the housing (2, 102, 202) comprises an outer surface (5, 105, 205) covered with an adhesive layer (12, 112, 212) adapted to fix the housing (2) to the skin (31) of a patient in proximity to a vascular plaque (32).

3. Device according to claim 1, in which the housing (302, 402) is in the form of a subcutaneous implant capable of being inserted under the skin of a patient, said housing comprising an outer surface (305, 405) intended to be brought into contact with the carotid wall (34).

4. Device according to claim 3, wherein the housing (402) comprises on said outer surface (405) intended to be placed in direct contact with the carotid wall (34) a diffusion layer (406) containing a medicinal product (6) intended to be diffused into the carotid wall (34).

5. Device according to one of claims 1 to 4, wherein said at least one diffusion device (10) further comprises: - a diffusion module (40, 50) comprising a proximal end (41, 51) in fluid communication with the reservoir (11) and a distal end (42, 52) provided with a diffusion head (43, 53), said diffusion module comprising a lumen (44, 54) for injecting the volume of medicinal product extending between the proximal end (41, 51) and the distal end (42, 52); - a displacement mechanism (14) coupled to the diffusion module (40, 50) to move it along a longitudinal axis (8) in the housing (2, 102, 202, 302, 402), between a rest position in which the diffusion module (40) is stored in the housing (2) and a diffusion position in which the diffusion head (43, 53) opens outside the housing (2) for being introduced into the vascular plaque (32) to diffuse the product into the plaque (32) or to be brought into contact with the carotid wall (34) to diffuse the product into the wall (34); - an injection mechanism (17) coupled to the reservoir (11) configured to inject a volume of medicinal product into the lumen (44, 54) of the diffusion module (40, 50) to diffuse the medicinal product via the diffusion head (43, 53).

6. Device according to claim 5, in which the diffusion module (40) comprises a cannula (46) capable of being moved by the displacement mechanism (14) along the longitudinal axis (8) in the housing (2), the proximal end of the cannula (46) being in fluid communication with the reservoir (11) and the distal end of the cannula forming the diffusion head being in the form of a tapered tip (43).

7. Device according to claim 5, wherein the diffusion module (50) comprises: - an outer sleeve (55), the distal end of the outer sleeve being provided with a tapered distal point (59), - a cannula (56) mounted coaxially in the outer sleeve (55), said cannula (56) being able to be moved along the longitudinal axis (8) in the outer sleeve (55), the proximal end of the cannula being in fluid communication with the reservoir (11) and the distal end of the cannula forming the diffusion head (53) being provided with a plurality of diffusion orifices (58).

8. Device according to one of claims 5 to 7, wherein said at least one diffusion device comprises a first diffusion device (120, 220, 320, 420) comprising a reservoir comprising a medicinal relaxation product (6) intended to be diffused onto the carotid wall (34) to reduce the rigidity of the wall and a second diffusion device (110, 210, 310, 410) comprising a reservoir comprising a homogenization product (7) intended to be diffused into the vascular plaque (32) to optimize the inertia of the vascular plaque.

9. Device according to one of claims 1 to 8, in which the homogenization product (7) is an alcohol solution, a surgical cement or a biological glue.

10. Device according to one of claims 1 to 8, in which the medicinal relaxation product (6) is a product chosen from the following products: NO donor, vasodilator, endothelin inhibitor, in- phosphodiesterase inhibitor, prostaglandin and derivatives, nitroglycerin, trinitrin.

11. Device according to one of claims 5 to 10, wherein said displacement mechanism (14) comprises an extensible connector (15) secured to a movable part of a piezoelectric displacement support (16), said connector (15) comprising a proximal end fixed to the reservoir and a distal end fixed to the proximal end of the diffusion module (40, 50), the displacement support (16) being configured to advance and retract the diffusion module (40) by axial extension of the connector (15).

12. The device of claim 11, wherein the expandable connector (15) comprises a lumen allowing fluid communication between the reservoir (11) and the diffusion module (40, 50) for conveying the drug product from the reservoir (11) to the distal end of the diffusion module to allow the product to be delivered by the diffusion head (43, 53).

13. A device according to one of claims 5 to 12, wherein the injection mechanism (17) comprises a piston (18) coupled to a piezoelectric drive mechanism (19) configured to move the piston (18) to exert pressure in the reservoir in order to circulate the drug product in the connector (15) and in the diffusion module (40, 50) towards the diffusion head (43, 53).

14. Device according to one of claims 1 to 13, wherein the housing (2, 102, 202, 302, 402) comprises a communication interface (3, 103, 203, 303, 403) adapted to receive a set of control signals intended to control said at least one broadcasting device (10, 110, 120, 210, 220, 310, 320, 410) and an energy source (4, 104, 204, 304, 404).

15. A vascular plaque treatment assembly (500) comprising a vascular plaque treatment device (1, 100, 200, 300, 400) according to one of the preceding claims, an imaging system (501) adapted to generate images of the housing positioned on the body of a patient, a control unit (502) comprising a user interface (506) and at least one control (504, 505) adapted to generate a set of control signals intended to control said at least one diffusion device (10, 110, 120, 210, 220, 310, 320, 410), and a communication interface (508) configured to communicate with said treatment device.

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