Method, apparatus, and crimper for crimping implantable devices

Abstract

A set of instruments for crimping a support structure (50) of a heart valve, including a first crown (56) and a second crown (58), the set of instruments including: - At least one device (61, 91) having a handle (62, 92) with one end terminated at a cylindrical body (64, 94), the side (66, 96) of the cylindrical body (64, 94) provided with a seat (68, 98) for receiving a first crown (56) of a support structure, and having a cap (74, 104) slidably positioned on the cylindrical body (64, 94) to secure the first crown, - At least one crimping ring (72, 102) for crimping the second crown (58).

Description

Technical Field

[0001] The present invention relates to a method, an instrument set, and a crimper (crimping device) for crimping implantable devices.

[0002] The present invention has been developed, in particular but not limited to, with the idea of crimping a support structure for a heart valve prosthesis, especially a support structure for a valve prosthesis replacing an atrioventricular valve. Here, and hereinafter, the term "support structure" is understood to mean a deformable structure to which an artificial valve leaflet that controls blood flow in the implanted valve prosthesis is fixed.

Background Art

[0003] Numerous crimping devices for artificial heart valves are known. The term "crimping" is understood in this field to mean an operation of reducing the dimensions (usually the radial dimensions) of an implantable device, particularly a vascular stent or an artificial valve for valve replacement. This operation is usually necessary for mounting the implant device on a low-profile catheter or other delivery system, which are used for implanting into a patient by a minimally invasive procedure. The crimping action may target the entire implantable device or only a part thereof.

[0004] The implantable devices subject to crimping can be long (i.e., their axial length is significantly greater than their diameter in the unfolded state) or short (i.e., their axial length is smaller than their diameter). Furthermore, the devices may have different shapes (i.e., different diameters in different parts) or geometric shapes other than cylindrical (complex three-dimensional profiles). The need to mechanically reduce the radial dimensions of complex structures (and avoid the risk of damage to the implantable device itself), as required in transcatheter procedures, necessitates the development of crimping devices and methods that are particularly versatile and efficient. Moreover, since the crimping procedure for artificial valve devices, in particular, is performed immediately before the implantation procedure, in the operating room, in a sterile environment, and directly by appropriately trained but non-specialized or non-technically skilled staff, such crimping devices must be easy and safe to operate.

[0005] Patent EP2014257 pertains to a crimping device specifically for short prostheses. While the device described in the patent can crimp multiple short devices, it is unsuitable for complex shapes and is particularly unsuitable when high precision is required at the point of application of the crimping action.

[0006] More generally, the problem with known types of apparatus and methods is that they cannot ensure high precision on the plane on which crimping takes place, and in any case, valves with transient cross-sections or complex shapes cannot be crimped without the risk of causing them to collapse. [Overview of the Initiative] [Problems that the invention aims to solve]

[0007] The object of the present invention is to solve the problems of the prior art. Another object is to provide a method, a set of tools, and a crimping device particularly suitable for crimping support structures of transplantable devices having non-steady cross-sections in a reliable and reproducible manner. Yet another object is to provide an economical, simple, and reliable device that can complete the crimping operation within an acceptable time that is compatible with the time required for the transplanting procedure. [Means for solving the problem]

[0008] To achieve these objectives, the present invention relates to a method, a set of tools, and a crimping device as described in the appended claims.

[0009] According to the first aspect, a crimping procedure and associated apparatus are described, which provide a series of steps having an intermediate configuration. This procedure and apparatus minimize deformation non-uniformity, thereby reducing the stress state within the prosthesis structure. Dividing the crimping procedure into a series of steps enhances the simplicity and reproducibility of the compression operation of the implantable apparatus, contributing to improved safety and work speed.

[0010] A second aspect describes a procedure for crimping a support structure for an implantable device. This structure has two ends. The procedure may include a first step of crimping one of the two ends of the support structure and a second step of crimping the other end. By crimping the ends separately, a stepwise operation is introduced, allowing for greater precision and safety while avoiding irregular or uncontrollable deformation. Preferably, these steps are repeated at least once, preferably in the same order, to guide the implantable device to the final desired crimp diameter. This makes the crimping action even more stepwise, minimizing the risk of valve collapse during crimping. More preferably, the above steps are repeated up to three times.

[0011] In the final iteration, the support structure can be attached to the catheter and / or delivery system for subsequent artificial valve implantation. The final step can be performed immediately before implantation, while the preceding steps can be performed well in advance of the delivery system usage time.

[0012] This procedure, subdivided into multiple steps, allows for more effective synchronization of the compression time and the implantation procedure time, ensuring the prosthesis is available for use while simultaneously avoiding the risk of the prosthesis remaining in a fully compressed state for longer than necessary. For example, with transcatheter valve prostheses, it is advantageous to properly perform the first stage of compression well in advance of the precise implantation time. This allows for an intermediate compression configuration that enables rapid and safe completion of the compression procedure, while simultaneously avoiding excessive compression of the biotissue assembly that typically constitutes the functional components of the prosthesis. In this way, the final compression step can be properly synchronized with the timing of the implantation procedure. This prevents the valve prosthesis from being held in a fully compressed state for an excessively long time, which can be detrimental to the functional components of the prosthesis. At the same time, it allows the operator to quickly make the delivery system available at the appropriate time for implantation, avoiding an increase in the time required for the intervention procedure.

[0013] In another aspect, a procedure for crimping the support structure of the implantable device is described. This procedure may include a first step of crimping one of the ends of the support structure. This step can be performed using a crimper of appropriate design and an instrument having a cylindrical body with projections on its outer surface.

[0014] In one aspect, a procedure for crimping a support structure for an implantable device is described. This procedure may include a first step of crimping one end of the support structure and a second step of crimping the other end. The second step can be performed using an instrument equipped with a crimping ring.

[0015] In one embodiment, a procedure for crimping a support structure for an atrioventricular heart valve prosthesis is described. The support structure has an atrial crown and a ventricular crown. This procedure may consist of a first step of crimping the atrial crown and a second step of crimping the ventricular crown, or the reverse order.

[0016] In one aspect, the procedure for crimping the support structure of an atrial-ventricular valve prosthesis is described. This procedure is subdivided into several steps, in which the crimped valve prosthesis can be inserted into the valve sac of the delivery system.

[0017] In another embodiment, a set of instruments for crimping a support structure for an atrioventricular valve prosthesis having an atrial crown and a ventricular crown is also described. This set may include at least one first type of instrument. The first type of instrument includes a cylindrical body having a diameter preferably smaller than the atrial crown of the support structure and is preferably fixedly coupled to a handle. A seat for receiving and preferably securing the atrial crown may be provided on the side of the cylinder. The first type of instrument includes an atrial cap that is slidable on the cylindrical body, thereby allowing the atrial crown to be fixed to the cylindrical body. Thus, the atrial cap has the function of fixing the diameter of the atrial crown to a diameter preferably smaller than the diameter of the undeformed support structure of the valve. This set may include at least one second type of instrument. The second type of instrument may include a crimping ring for crimping the ventricular crown of the support structure.

[0018] The instrument set may further include a second crimping ring for crimping the ventricular crown and a positioning cap to assist in inserting the second crimping ring into the ventricular portion of the valve replacement body.

[0019] Preferably, the instrument set includes a first and second instrument of the first type, the second instrument differing from the first instrument in that the radial dimensions of the cylindrical body and atrial cap are reduced. Preferably, the instrument set also includes three different instruments of the second type, mainly differing in the inner diameter of the crimping ring. Preferably, at least one instrument of the second type also includes a positioning cap, which is preferably associated with a smaller diameter crimping ring. Naturally, different configurations of the instrument set for crimping the support structure of the implantable device are also possible.

[0020] Another aspect described is the procedure for crimping the support structures of implantable devices (e.g., atrioventricular valve prostheses). This procedure combines the use of a crimping instrument set with the use of a properly designed crimper (crimping device).

[0021] In another embodiment, a crimper for crimping a support structure for an implantable device is described. The crimper is configured to reduce the radial dimension of the support structure in a manner limited to a portion of the support structure that is negligible in length relative to the overall length of the support structure itself. The crimper includes a plurality of movable crimping structures that are significantly thinned relative to the axial dimension of the support structure, which together define a plane having holes. The diameter of the holes is arbitrarily changeable and can be controlled by acting on the crimping structures. The crimping structures may further define a pair of openings. [Brief explanation of the drawing]

[0022] Additional features and advantages will become apparent from the detailed description of preferred embodiments of the invention with reference to the accompanying drawings. The drawings are provided as non-limiting examples and are shown below: - Figure 1 is a perspective view of the crimper (crimping device) and support structure of the atrioventricular heart valve prosthesis to be crimped. - Figure 2 is a side view of the crimper shown in Figure 1 in the state of maximum radial crimping. - Figure 3 shows the first pair of tools belonging to the crimping tool set. - Figure 4 shows the second pair of tools belonging to the crimping tool set. - Figure 5 shows the third instrument belonging to the crimping tool set. - Figure 6 shows details of the support structure of the atrioventricular heart valve prosthesis in the first crimping process. - Figure 7 shows the support structure of an atrioventricular valve prosthesis in which the atrial crown and ventricular crown are compressed with the first pair of devices. - Figure 8 shows the support structure for the atrioventricular valve prosthesis inserted into the crimper with the atrial crown compressed by the second device. - Figure 9 shows the support structure of an atrioventricular heart valve prosthesis in which an atrial crown and a ventricular crown are crimped using a second pair of instruments. - Figures 10 through 16 show the steps of inserting the prosthesis into the valve sac of a valve release instrument having retrograde access to the biological valve, following the steps of Figure 9. Specifically: - Figure 10 shows the support structure of an atrioventricular heart valve prosthesis in which the ventricular crown is crimped by a ring of the second pair of instruments and inserted between the artificial valve leaflets in an empty valve sac. - Figure 11 shows the support structure of an atrioventricular heart valve prosthesis in which the atrial crown is crimped to the delivery system of Figure 10. - Figure 12 shows the support structure of an atrioventricular heart valve prosthesis in which the atrial crown is inserted into the valve capsule of Figure 10. - Figure 13 shows the support structure of an atrioventricular heart valve prosthesis in which the atrial crown is inserted into the valve capsule of Figure 10 and the ventricular crown is crimped with a crimper. - Figure 14 shows the support structure of an atrioventricular heart valve prosthesis having an atrial crown inserted into the valve capsule of Figure 10 and a ventricular crown partially crimped by a third instrument. - Figure 15 shows the support structure of an atrioventricular heart valve prosthesis in which the ventricular crown is completely crimped by a third instrument using a positioning cap. - Figure 16 shows the support structure of an atrioventricular heart valve prosthesis completely crimped within the valve capsule of Figure 10. - Figures 17 through 22 show the steps of attaching the prosthesis to a delivery system for antegrade access to the biological valve, following the steps of Figure 9. Specifically: - Figure 17 shows the support structure of an atrioventricular heart valve prosthesis in which the atrial crown is crimped onto a valve support provided on the delivery system. - Figure 18 shows the support structure of an atrioventricular heart valve prosthesis having an atrial crown inserted into a valve membrane provided on the delivery system. - Figure 19 shows the support structure of an atrioventricular heart valve prosthesis similar to that of Figure 18, with the connecting arms 52 straightened and joined to each other. - Figure 20 shows the support structure of an atrioventricular heart valve prosthesis in which the atrial crown is inserted into the valve capsule and the ventricular crown is crimped by a crimper and crimping cap. - Figure 21 shows the crimping cap from Figure 20 inserted into the ventricular crown of the support structure for the atrioventricular heart valve prosthesis. - Figure 22 shows the valve capsule in the state where it has advanced to the crimping cap. [Modes for carrying out the invention]

[0023] Referring to the drawings, Figure 1 shows a crimper 10 suitable for crimping implantable devices, such as minimally invasive heart valve prostheses. An example of such an artificial device is described in patent application PCT / IB2020 / 056960 by the same applicant. This is an atrioventricular valve prosthesis formed by an artificial structure for supporting and joining a bioprosthetic valve and a series of flexible artificial valve leaflets fixed inside it. The prosthesis in particular includes a support structure 50 (see Figure 1), which is a radially expandable central body to which artificial valve leaflets that functionally replace the bioprosthetic valve when in use are fixed. The support structure is provided with connecting arms 52, which terminate as connecting blocks 53 in an annular portion not shown. The support structure has an atrial crown 56 (the end facing the atrium (blood inflow side) when in use) and a ventricular crown 58 (the end facing the ventricle (blood outflow side) when in use).

[0024] This support structure can be manufactured from a superelastic material, typically an isoatomic alloy of nickel and titanium (commercially known as Nitinol), and therefore the compression action aims to deform the support structure, transitioning it from a radially expanded state to a radially contracted state compatible with the dimensions and transcatheter insertion of the delivery system. For this purpose, a force is applied that opposes the elastic repulsive force of the structure itself (the force attempting to maintain the expanded state).

[0025] The crimper 10 preferably consists of a pair of interconnected plates 12 and 16, which form a first plate system. The crimper 10 further preferably comprises a second plate system, which is fixedly joined to the base of the crimper. In the illustrated embodiment, the second plate system comprises a plate 14. The two plate systems 12, 16 and 14 are rotatable relative to each other about a common axis A. The plates of the first plate systems 12 and 16 are fixed to each other, with the plate 14 of the second plate system interposed between them. The plate 14, which is only partially visible in the drawing, comprises a support portion 20 for fixing to the base 21 of the crimper. The plates 12, 14 and 16 are provided with holes 22, 24 and 26, respectively. The holes 22, 24 and 26 of the plates 12, 14 and 16 are aligned with respect to the same axis of rotation (common axis) A.

[0026] The first plate systems 12 and 16 are fixed to the handle 28. The handle 28 allows the operator to rotate the first plate systems 12 and 16 relative to the plate 14.

[0027] Figure 2 shows the plate 12 of the first plate system 12. The plate 12 is preferably provided with curved slots 32 that define an arc. The slots 32 are arranged radially around the hole 22 such that the inner end 33 of each slot 32 is close to the hole 22 of the plate 12 and the outer end 34 is close to the edge 31 of the plate 12. Furthermore, the concave surfaces of the slots 32 always face in the same direction (clockwise or counterclockwise). The angular position of the inner end 33 of each slot 32 is different from the angular position of the outer end 34 of the same slot, and the angular distance α between the two ends of the same slot 32 is constant for all slots 32. The slots 32 have a constant angular distance.

[0028] Plate 16 of the first plate system has slots not shown in the drawing, which are identical to and coupled to the slots 32 of plate 12 described above, such that each slot 32 of plate 12 corresponds to a notch in plate 16.

[0029] Plate 14 is provided with slots (not shown), which are similar to the slots 32 of plate 12, but the recesses face in the opposite direction to those used in the first plate systems 12 and 16. As a result, each slot on plate 14 intersects with at least one slot 32 on the first plate systems 12 and 16.

[0030] In one example of a crimper configuration, multiple crimping structures are housed between plate 12 and plate 14. In this example, they take the form of wedges 42. Each crimping structure is provided with at least one sliding element 44 that can slide within the aforementioned slot. The crimping structures and slots are configured to jointly define a variable-diameter hole 46 depending on the relative positional relationship of the crimping structures. The diameter of the hole 46 is variable by operating the handle 28 to rotate the first plate systems 12 and 16 relative to plate 14. Figure 2 shows a crimper with a reduced-diameter hole 46. In this configuration, it can also be seen that a pair of openings 48 exist on the crimping structures. Their usage will be described later.

[0031] The largest diameter hole 46 can accommodate the support structure 50 of an undeformed artificial joint. By positioning the support structure 50 in the hole 46 and reducing its diameter, it is possible to locally reduce the radial size of the support structure, allowing the crimping action to be concentrated on a precise portion with a limited axial length compared to the axial length of the artificial joint. The crimping is performed on a plane; that is, the crimping action is applied with high precision along the intersection line of the support structure 50 and the plane perpendicular to it and defined by the crimping structure. However, the applicant has found through experimentation that, for prostheses of certain shapes and dimensions, crimping by the above type of crimper alone is ineffective, not only making crimping difficult or impossible, but also potentially causing defects such as collapse or irregular deformation of the support structure, which can pose a risk to the integrity of the prosthesis itself.

[0032] To avoid the above risks, the applicant developed the instrument sets shown in Figures 3, 4, and 5. These will hereafter be referred to as the first instrument pair 60, the second instrument pair 90, and the third instrument pair 120, respectively.

[0033] The first instrument pair 60 consists of an instrument 61 and a crimping ring 72. The instrument 61 has a handle 62 terminated at one end by a cylindrical body 64, which is preferably (but not necessarily) coaxial with the handle and has a seat 68 on its side 66 for receiving the atrial crown 56 of the support structure. In a specific case, as shown in Figure 1, the support structure has a plurality of loops 54 on the atrial crown, which are arranged around projections 70 provided on the seat 68. If the instrument 61 is used with a support structure of a different shape, then of course, seats 68 of different shapes are provided to match the shape of the end of the support structure. It is not necessarily required that each seat 68 has a projection 70. In the structural solution of the valve prosthesis shown in Figure 1, it is preferable that at least one seat 68 has a projection 70 in order to exert a fixing action of the support structure on the cylindrical body 64. If the geometry of the support structure is different, this fixing action may be applied by the seat 68 itself. An atrial cap 74 is associated with the cylindrical body 64. The atrial cap 74 has a generally tubular structure and is equipped with a hole 76 for inserting and sliding the handle 62. Furthermore, it is equipped with a cavity 78 of a shape and size that accommodates the cylindrical body 64 and restrains the end of the support structure within the seat 68, thereby resisting the elastic radial force exerted by the structure itself. The atrial cap is preferably formed of a transparent material (e.g., plastic material) so that the operator can see the support structure within the seat 68.

[0034] Referring to the valve prosthesis 50 shown in Figure 1, the diameter of the cylindrical body 64 of the device 61 is smaller than that of the atrial crown 56 in its freely expanded state, i.e., before compression.

[0035] As mentioned above, the first pair of devices 60 further includes a crimping ring 72. Referring to the valve replacement body 50 shown in Figure 1, the inner diameter of the crimping ring 72 is smaller than the ventricular crown 58 in the free-expanded state before the crimping process. Preferably, the atrial cap 74 needs to have external dimensions that allow the crimping ring 72 to slide over it.

[0036] In the crimping process, if it is advantageous to have a crimping ring 72 with an inner diameter smaller than the outer dimensions of the atrial cap, the crimping ring 72 may be configured in an open shape or may be divided into at least two separate parts, and may include additional parts that surround and stabilize the ring when it is coupled to the ventricular portion of the support structure.

[0037] The second pair of instruments 90 is generally similar to the first pair of instruments 60 described above, but includes components with smaller diameter dimensions than the first pair of instruments 60 for crimping the support structure. This consists of an instrument 91 and a crimping ring 102. The instrument 91 has a handle 92 ending at one end of a cylindrical body 94, the outer diameter of which is smaller than that of the cylindrical body 64. The side surface 96 of the cylindrical body 94 is provided with a seat 98 for receiving one end of the support structure. In the case of the illustrated support structure, the seat 98 is formed to receive the loop end of the atrial crown 56. These seats are closer to each other than the seat 68 and have dimensions that allow for a stronger crimping of the support structure 50, i.e., a smaller radius dimension. Depending on the shape of the end of the support structure, a projection 100 may still be provided on at least one of the seat 98. In fact, depending on the shape of the end of the support structure, the shape of the seat 98 alone may be sufficient to fix the cylindrical body 94 to the support structure, or additional fixing elements may be required. An atrial cap 104 is associated with the cylindrical body 94 and has a hole 106 for inserting and sliding the handle 92. The atrial cap 104 further includes a cavity 108 formed and sized to accommodate the cylindrical body 94. The cavity 108 is further formed to fix the end of the support structure within the seat 98 against the elastic radial force of the support structure itself.

[0038] The second pair of instruments 90 further comprises a crimping ring 102. Preferably, the inner diameter of the crimping ring 102 is smaller than the inner diameter of the crimping ring 72 of the first pair of instruments 60. Preferably, the atrial cap 104 has external dimensions that allow the crimping ring 102 to slide over it.

[0039] The third pair of fixtures 120 includes a crimping ring 122 and a positioning cap 124. The inner diameter of the crimping ring 122 is preferably smaller than the inner diameter of the crimping ring 102 of the second pair of fixtures 90. The positioning cap 124 is characterized by a dead-end internal cavity.

[0040] The three sets of instruments described above are used in conjunction with a crimping device (preferably a crimper 10) to enhance versatility and efficiency when crimping support structures having varying lengths and variable cross-sections that are not necessarily cylindrical. For this purpose, crimping is performed in stages, preferably by sequentially partially crimping the atrial and ventricular crowns until dimensions suitable for the placement of the implantation prosthesis into the delivery system are obtained. The crimping procedure is described below.

[0041] Using the valve prosthesis 50 shown in Figure 1 as an example, in the case of a nitinol-based prosthesis, it is advantageous to immerse it in physiological saline solution at a temperature lower than its transformation temperature before crimping the support structure 50. This causes the alloy to undergo a phase transformation from the austenite phase to the martensite phase, making the support structure plastically deformable and thus facilitating crimping. This operation can be performed multiple times during the process described later.

[0042] In the first stage of the crimping procedure, the handle 28 of the crimper 10 is rotated until the hole 46 is fully opened. Next, one end of the support structure is inserted into the hole 46 of the crimper 10, and the connecting arm is positioned on one side of the crimper 10 (the right side in the example in Figure 6) and the atrial crown 56 on the other side. Then, the handle 28 is rotated in the opposite direction until the wedge 42 contacts the base of the atrial crown 56 and the support structure is stable within the hole 46 of the crimper 10.

[0043] Next, the cylindrical body 64 of the instrument 61 is inserted into the support structure and positioned so that the atrial loops 54 of the support structure are aligned with the seats 68 formed on the outer surface 66. Next, the atrial crown 56 of the support structure is crimped until each atrial loop 54 fits into the corresponding seat 68 (see Figure 6) and projection 70 (if present). Next, the atrial cap 74 is slid onto the cylindrical body 64 and the atrial crown 56 of the support structure until it contacts the wedge 42 of the crimper 10. This restrains the atrial crown of the support structure to a predetermined diameter by the atrial cap 74 and securely fixes it on the instrument 61. This diameter is preferably equal to the radius of the cavity 78 and smaller than the initial diameter of the support structure.

[0044] Next, the crimper 10 is opened and the support structure is removed. As shown in Figure 7, by keeping the support structure clamped to the instrument 61, the connecting arm 52 is slightly separated, and the crimping ring 72 is slid onto the atrial cap 74 and the ventricular crown of the support structure until it reaches the opposite end. This results in the corresponding radial reduction of the ventricular crown.

[0045] In the second stage of the crimping procedure, the support structure is reinserted. At this time, the support structure remains attached to the instrument 61, and the crimping ring 72 is positioned in the opening 46 of the crimper, still located in the ventricular crown. Again, the handle 28 of the crimper 10 is operated to fit the hole 46 to the diameter of the support structure. Then, the atrial cap 74 is retracted to release the atrial crown 56. Subsequently, the instrument 61 is separated from the support structure. This stably holds the atrial crown 56 in place at the fixed diameter inside the crimper 10.

[0046] Next, the cylindrical body 94 of the instrument 91 is inserted into the atrial crown 56 of the support structure, replacing the removed instrument 61. As described above for instrument 61, the atrial crown 56 of the support structure is further compressed until each atrial loop 54 is received in its corresponding seat 98 (Figure 8) and positioned around the projection 100, if present. Then, the atrial cap 104 is slid onto the cylindrical body 94 and the atrial crown 56 of the support structure. This securely fixes the atrial crown of the support structure on instrument 91 and restrains it to a predetermined diameter by the atrial cap 104. The diameter of the atrial crown is determined in particular by the radius of the cavity 108. This diameter is smaller than the diameter in the process shown in Figure 6. In the process shown in Figure 6, the atrial crown was fixed to instrument 61 by the atrial cap 74, so its diameter was determined by the radius of the cavity 78 of instrument 61.

[0047] Next, the crimper 10 is opened and the support structure is removed from it. With the support structure still fixed to the instrument 91, the crimp ring 72 of the first instrument pair 60, which is still located at the ventricular end of the support structure, is removed. The connecting arm 52 is slightly separated and the crimp ring 102 is slid into the atrial cap 104 and the ventricular crown of the support structure and moved until it reaches the opposite end. This provides further radial reduction of the ventricular crown. The support structure thus configured is shown in Figure 9. The support structure is balanced in terms of the reduction in diameter along axial development and can therefore be maintained in this configuration for a relatively long period of time.

[0048] With the support structure still attached to the device 91, it is possible to orient the prosthetic valve in a predetermined direction. This is to accommodate the case when the prosthetic valve needs to be coupled to the delivery system while maintaining a predetermined orientation. Maintaining this orientation, the support structure is inserted into the hole 46 of the crimper, still attached to the device 91 and with the crimping ring 102 positioned at the ventricular end. Again, the handle 28 of the crimper 10 is operated to narrow the hole 46 to the diameter of the support structure. Then, the atrial cap 104 is removed, releasing the atrial crown 56 and detaching the device 91 from the support structure.

[0049] In the crimping procedure, it is possible to include additional intermediate steps similar to those described above, which allows the size of the support structure (and thus the artifact) to be adjusted to be compatible with the final attachment step to the delivery system.

[0050] In the final step of the crimping procedure, the implantable prosthesis is fitted into the delivery system. Figure 10 shows, for example, a valve delivery system 150 of the type described in Patent IT0001414559 by the same applicant. It comprises a valve capsule 152 for inserting the implantable prosthesis (or a portion thereof) and allowing release at a predetermined position. The delivery system 150 is provided to allow retrograde access to the valve. The support structure can be fixed around a appropriately molded valve support portion 154 when inserted into the capsule.

[0051] To attach the prosthesis to the delivery system 150, the valve capsule 152 is inserted through the prosthesis 50, positioning the support 154 in the region of the atrial loop 54 of the support structure. This allows the capsule 152 to first cover the atrial crown of the prosthesis and then advance toward the ventricular crown. The release of the prosthesis during implantation proceeds in the reverse order. The design of the delivery system 150 is intended to first release the ventricular crown of the support structure and then fix the atrial crown of the prosthesis 50 to the valve support 154 while holding it within the capsule 152. Finally, the atrial crown is also released (achieved by completely separating the capsule 120 from the support 154), completing the final implantation of the prosthesis.

[0052] To prevent damage to the artificial valve leaflets located inside the support structure as the capsule 152 advances within the prosthesis, the artificial valve leaflets can be separated and opened using the handle 62 of device 61 or the handle 92 of device 91, thereby allowing the safe passage of the valve capsule 120. For this purpose, the handle 92 or 62 can be inserted from the atrial crown 56 side (left side in the figure) to keep the artificial valve leaflets open and pass through the artificial valve. From the opposite side (right side in the figure), the tip of the valve capsule 152 is approached. Next, the tip of the capsule is brought into contact with the handle 92 of the second device. While maintaining contact between both components, the valve capsule is advanced through the support structure without damaging the artificial valve leaflets.

[0053] During the crimping or implantation procedure, the delivery system 150 is adjusted to the appropriate orientation relative to the prosthetic valve 50, and the atrial crown 56 is further crimped onto the valve support 154 (Figure 11). In this step, it is desirable to maintain substantially equal spacing so that the atrial loops do not overlap. To secure the support structure, particularly the atrial loops 54, to the delivery system via the valve support 154, it is preferable that the valve support 154 is provided with one or more projections 156 that can be fitted into the atrial loops.

[0054] Once the atrial crown 56 is correctly positioned on the valve support 154, the valve capsule 152 is moved to cover the atrial crown 56 of the valve, as shown in Figure 12. The support structure and the valve delivery system are then removed from the crimper to confirm that the atrial crown 56 of the support structure is correctly positioned within the valve capsule 152.

[0055] The final valve compression step, described below, should ideally be performed immediately before using the delivery system for the implantation procedure. This procedure completes the ventricular compression of the prosthetic valve, resulting in maximum compression of the valve's biological components, particularly the leaflets. Prolonged compression of the prosthetic leaflets can cause partial drying, which can lead to damage.

[0056] To perform the final crimping of the support structure, the crimping rings 102 of the second pair of instruments 90 are removed from the support structure. Referring to Figure 13, the support structure is then inserted into the hole 46 of the crimper 10, ensuring that the wedge 42 of the crimper 10 is positioned to correspond to the ventricular crown 58 of the support structure. The support structure of the atrioventricular valve prosthesis 50 illustrated here for reference in explaining the crimping procedure has, as mentioned above, a pair of connecting arms 52 that can interfere with proper crimping of the ventricular crown. This problem is strictly due to the specific shape of the support structure and does not necessarily occur with support structures of different shapes. To resolve this, the connecting arms 52 are inserted into openings 48 provided in the wedge 42.

[0057] Subsequently, the crimper 10 is activated to reduce the hole 46 to a diameter that allows the crimping ring 122 of the third device 120 to be inserted from the valve capsule 152 side. The crimping ring 122 is pushed up to the wedge 42 of the crimper. A positioning cap 124 can also be used to easily push the crimping ring 122 onto the wedge 42.

[0058] The crimper is opened and the group formed in this manner is extracted. Next, the positioning cap 124 of the third instrument 120 is placed over the valve capsule 152, and the positioning cap is pressed so that the crimping ring 122 reaches the ventricular end of the support structure, as shown in Figure 15. The depth of the recess in the positioning cap 124 can be appropriately designed so that the tip of the capsule 152 contacts the bottom surface of the recess, precisely corresponding to the correct positioning of the crimping ring 122 at the ventricular end of the support structure. This prevents the ring 122 from accidentally coming off the support structure. Finally, the positioning cap 124 is removed.

[0059] After substantially stabilizing the support structure in a configuration that satisfies minimal spatial requirements by the valve capsule 152 on the atrial side and the crimping ring 122 on the ventricular side, the capsule 152 is advanced along the remaining length of the support structure. To complete this final step, it is beneficial to further use the crimper 10 to reduce the radial cross-sectional area of ​​the implantable prosthesis immediately adjacent to the edge of the valve capsule 152. This prevents blockage of the capsule itself and irregular arrangement of the prosthesis components in the minimal spatial requirements configuration.

[0060] This causes the support structure 50 to be crimped and inserted into the valve capsule 152.

[0061] It should be noted that the procedure described above may naturally vary depending on the specific characteristics of the support structure. A key feature of this procedure is that the entire support structure is not crimped simultaneously, but rather the atrial crown 56 is crimped first, followed by the ventricular crown 58. In this case, it is possible to pass through an intermediate stable state, which has the advantage of avoiding the risk of collapse or damage to the prosthesis and making the procedure easier to perform. Furthermore, the possibility of performing the procedure in reverse, i.e., crimping the ventricular crown first and then the atrial crown, is not ruled out. It is also possible to use crimpers of different shapes, as long as crimping is possible along a crimping surface perpendicular to the axis of the support structure.

[0062] Additional examples of this procedure are described below with reference to Figures 17-22, which show the steps following the step of fixing the support structure shown in Figure 9 to the delivery system for antegrade access to the congenital valve. For example, the same applicant's international patent application WO 2021 / 014400 and the subsequent Italian patent application IT102022000001166 describe a delivery system for antegrade access to the mitral valve.

[0063] The treatment delivery system 250 using an antegrade approach, partially shown in Figure 17, includes a capsule 252 and a valve support 254. Preferably, the valve support 254 is provided with one or more projections 256 suitable for engaging with the atrial loop 54 to secure the support structure, particularly the atrial crown, to the delivery system.

[0064] After performing the procedures described up to Figure 9, the support structure is inserted into the crimper hole 46, still attached to the device 91 and with the crimping ring 102 positioned towards the ventricular side. With the support structure still attached to the device 91, it is possible to orient the prosthetic valve in a predetermined direction. This is applicable when a predetermined orientation must be maintained when coupling the prosthetic valve with the delivery system. While maintaining this orientation, the handle 28 of the crimper 10 is operated to narrow the hole 46 to the diameter of the support structure. Then, the atrial cap 104 is removed, releasing the atrial crown 56 and simultaneously detaching the device 91 from the support structure.

[0065] Next (Figure 17), the valve support 254 is inserted into the atrial crown 56. Then, it is pressed into place until the atrial crown engages with the projection 256 of the valve support 254.

[0066] Next, the valve capsule 252 is advanced to stably fix the atrial crown on the valve support 254, as shown in Figure 18.

[0067] As described in the preceding Italian patent application IT102022000001166, the connecting arm 52 of the artificial valve is then extended to enable the use of a capsule with reduced radial dimensions (Figure 19). The connecting blocks 53 are connected to each other using, for example, a guide wire 258 that passes through a special attachment provided on the block itself.

[0068] Referring to Figure 20, in the case of a delivery system for antegrade procedures, a ventricular cap 134 can be used instead of the device in Figure 5. The ventricular cap 134 has a tubular shape with an inner diameter equal to the desired diameter of the crimped support structure. Inside, the ventricular cap 134 has an abutment element 136.

[0069] To perform the final crimping of the support structure, the crimper 10 is slightly opened and the wedge 42 of the crimper 10 is moved to a position corresponding to the ventricular crown 58 of the support structure. To do this, the crimping ring 102 of the second pair of instruments 90 is slightly moved. Next, the ventricular crown is crimped to a diameter that matches the inner diameter of the ventricular cap. Then, as shown in Figure 20, the crimping ring 102 is removed from the ventricular side of the support structure.

[0070] Subsequently, the ventricular cap 134 is inserted from the same side of the support structure. At this time, it is inserted until the ventricular end 58 of the support structure contacts the abutment element 136 inside the ventricular cap 134 (see Figure 21).

[0071] This stabilizes the support structure at the crimping diameter between the atrial crown valve capsule and the ventricular cap 134. At this point (Figure 22), the capsule 252 is advanced along the crimped support structure to the ventricular cap, with the assistance of the crimper 10 as needed, to complete the valve crimping. The crimper 10 can then be moved to a section immediately distal to the edge of the valve capsule to facilitate the advancement of the capsule 252.

[0072] Naturally, the principle of the invention remains the same, and with respect to what is described and illustrated, the details of the form and structure of the embodiments can be broadly modified without departing from the scope of the invention. Depending on the characteristics of the support structure, it should not be ruled out that, for example, a set consisting of only one of the first and second pairs of 60 and 90 should be provided. Preferably, a set including three or more pairs of 60 and 90 identical to the third utensil of type 120 can be considered for a faster but less progressive crimping procedure, or conversely, for a more progressive crimping procedure.

[0073] Embodiments:

[0074] 1. A method for crimping a support structure (50) of a portable device, wherein the support structure has two ends, and the method includes the following steps: a. Crimp one end of the support structure. b. Then, crimp the other end.

[0075] 2. The method according to claim 1, wherein steps (a) and (b) are repeated at least twice, preferably in the same order.

[0076] 3. In the method described in the preceding paragraph, steps (a) and (b) are repeated three times.

[0077] 4. A method according to any of the claims in the preceding paragraph, wherein step (a) is carried out using a crimper (10) and an instrument comprising a cylindrical body (64, 94, 154, 254) having projections (70, 100, 156, 256) on its outer surface.

[0078] 5. A method according to any of the claims in the preceding paragraph, wherein step (b) is performed using an instrument equipped with a crimping ring (72, 102, 122) or a ventricular cap (134).

[0079] 6. A method according to any of the claims in the preceding paragraph, wherein the implantable device is an atrioventricular heart valve, and the two ends are an atrial crown and a ventricular crown, respectively.

[0080] 7. A set of instruments for crimping the support structure (50) of the atrioventricular heart valve, including the atrial crown (56) and the ventricular crown (58), the set of instruments including the following: - At least one device (61, 91) having a handle (62, 92) with one end terminated at a cylindrical body (64, 94), a seat (68, 98) provided on the side of the cylindrical body (64, 94) for receiving an atrial crown (56) of a support structure, and an atrial cap (74, 104) that is slidable on the cylindrical body (64, 94) for securing the atrial crown, - At least one crimping ring (72, 102) for crimping the ventricular crown (58).

[0081] 8. The instrument set described in the preceding paragraph, further comprising an additional crimping ring (122) for further crimping the ventricular crown, and a positioning cap (124) for assisting the insertion of the additional crimping ring (122) of the support structure (50) into the ventricular crown.

[0082] 9. The instrument set according to claim 7, further comprising a ventricular cap (134) for further compressing the ventricular crown to assist in the operation of inserting the support structure (50) into the delivery system (250).

[0083] 10. A method for crimping a support structure for an atrioventricular heart valve prosthesis according to any one of claims 1 to 6, wherein the crimping device set and crimper according to claim 7, 8, or 9.

[0084] 11. A crimper comprising at least first plates (12, 16) and at least second plate (14) rotatable relative to each other about a common axis (A), wherein a plurality of crimping structures are received between the first plate (12, 16) and the second plate (14), each configured to collectively define holes (46) having a variable diameter according to the relative positioning of the crimping structures, and the crimping structures further define a pair of openings (48).

Claims

1. A set of instruments for crimping a support structure (50) of a heart valve, including a first crown (56) and a second crown (58), the set of instruments including: - At least one device (61, 91) having a handle (62, 92) with one end terminated at a cylindrical body (64, 94), the side (66, 96) of the cylindrical body (64, 94) provided with a seat (68, 98) for receiving a first crown (56) of a support structure, and having a cap (74, 104) slidably positioned on the cylindrical body (64, 94) for securing the first crown, - At least one crimping ring (72, 102) for crimping the second crown (58).

2. Furthermore, the apparatus set according to claim 1 includes the following: - A second apparatus (91) similar to at least one apparatus (61), wherein the diameter of the cylindrical body (94) and cap (104) is smaller than the diameter of the cylindrical body (64) and cap (74) of at least one apparatus (61), - A second crimp ring (102) that is similar to at least one crimp ring (72) and has a smaller diameter than at least one crimp ring (72).

3. An instrument set according to claim 1 or 2, further comprising an additional crimping ring (122) for further crimping a second crown, and a positioning cap (124) for assisting the insertion of the additional crimping ring (122) into the second crown of the support structure (50).

4. An instrument set according to any of the claims of the preceding paragraph, further comprising a cap (134) for further crimping a second crown to assist in the operation of inserting a support structure (50) into a delivery system (250).

5. A device set according to any of the claims in the preceding paragraph, wherein the heart valve is an atrioventricular heart valve and the two crowns are an atrial crown and a ventricular crown, respectively.

6. A method for crimping a support structure (50) of a heart valve using an instrument set according to any one of claims 1 to 5, wherein the support structure has a first crown (56) and a second crown (58), and the method comprises the following steps: a. The first crown of the support structure is pressed against the cylindrical body (64, 94) of at least one device (61, 91) and secured using a cap (74, 104). b. The next step is to crimp the second crown using crimping rings (72, 102).

7. A method according to claim 6, further comprising the following steps: c. A step of further pressing a first crown around the cylindrical body (154, 254) of the heart valve delivery system (150, 250), wherein the cylindrical body (154, 254) has projections (156, 256) on its outer surface, d. The next step is to press the second crown into place.

8. In the method described in the preceding paragraph, step (d) is carried out using an instrument equipped with a crimping ring (122) or a cap (134).

9. A method according to claim 7 or 8, further comprising the following steps between step (b) and step (c): b1. A step of further pressing the first crown of the support structure around a cylindrical body (94) having a diameter smaller than the diameter of the cylindrical body (64) used in step (a) and larger than the diameter of the cylindrical bodies (154, 254) used in step (c), b2. A step in which the second crown is crimped using a crimping ring (102) with a smaller diameter than the crimping ring (72) used in step (b).

10. A method according to any one of claims 6 to 9, wherein step (a) and / or step (b1) and / or step (c) and / or step (d) is carried out using a crimper (10).

11. A method for crimping a support structure (50) of a heart valve, wherein the support structure has a first crown and a second crown, and the method comprises the following steps: i. A step of pressing the first crown of the support structure against the first diameter of the first crown, ii. The step of maintaining the state in which the first crown is pressed against the first diameter of the first crown, and pressing the second crown against the first diameter of the second crown, iii. Maintaining the state in which the second crown is pressed against the first diameter of the second crown, and pressing the first crown against the second diameter of the first crown which is smaller than the first diameter of the first crown, iv. The step of maintaining the state in which the first crown is pressed against the second diameter of the first crown, and pressing the second crown against the second diameter of the second crown which is smaller than the first diameter of the second crown.

12. The method described in the preceding paragraph, further comprising the following steps: v. Maintaining the state in which the second crown is pressed against the second diameter of the second crown, and pressing the first crown against the third diameter of the first crown which is smaller than the second diameter of the second crown, vi. The step of maintaining the state in which the first crown is crimped with the third diameter of the first crown, and crimping the second crown with the third diameter of the second crown which is smaller than the second diameter of the second crown.

13. A method according to claim 11 or 12, wherein step (i) and / or step (iii) and / or step (v) and / or step (vi) is carried out using a crimper (10) and an instrument comprising a cylindrical body (64, 94, 154, 254) having projections (70, 100, 156, 256) on its outer surface.

14. A method according to any of the claims of the preceding paragraph, wherein the heart valve is an atrioventricular heart valve and the two crowns are an atrial crown and a ventricular crown, respectively.

15. A crimper comprising at least first plates (12, 16) and at least second plate (14) rotatable relative to each other about a common axis (A), wherein a plurality of crimp structures are received between the first plates (12, 16) and the second plate (14), each configured to collectively define holes (46) having a variable diameter according to the relative positioning of the crimp structures, the crimp structures further define a pair of openings (48), and the crimper is suitable for use in the method according to any one of claims 6 to 14.

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