Compact curling device

Abstract

A compact crimping mechanism well suited for use with devices such as stented prosthetic heart valves. The crimping mechanism includes a plurality of jaws configured to move inwardly in a coordinated manner toward a crimping axis to reduce the size of a crimped iris around a stented valve. A rotating cam acts on the jaws and moves the jaws inwardly. A plurality of Cartesian guide elements cooperate with the jaws to distribute forces within the crimping mechanism. The guide elements are located between the crimping jaws and an outer housing and are constrained by the outer housing to move along a line tangential to a circle centered on the crimping axis. The guide elements engage at least some of the crimping jaws while the remaining crimping jaws are in meshing engagement for synchronous movement. An actuation mechanism includes a leadscrew, a carriage assembly, and a connecting rod for rotating the cam with substantial torque.

Description

[0001] This application is a divisional application of Chinese patent application 201780044281.2 (PCT / US2017 / 039060) filed on June 23, 2017 and entitled “Compact Curling Device”. Technical Field

[0002] The present invention relates to a crimping device and, more particularly, to a compact device for crimping a device (eg, a stented prosthetic valve, such as a heart valve, from a large diameter to a small diameter). Background Art

[0003] A stent is a roughly cylindrical prosthesis that is introduced into the lumen of a body vessel by a catheterization technique. A stent can be self-expanding or balloon expandable. Balloon expandable stents are usually curled from an initial large diameter to a smaller diameter before being advanced to the treatment site in the body. Before curling, a balloon expandable stent is usually placed on an expandable balloon on a catheter shaft. In the case where the stent is manufactured with its fully curled diameter, the stent is expanded on the balloon and then curled. To ensure safety, the curling process should be performed in a sterile environment. Over the years, attempts have been made to curl the stent on the balloon during surgery in a sterile field. However, most stents are now "pre-curled" on a suitable balloon in the factory and then handed over to the doctor for ready use.

[0004] One example of a crimping device for a stent based on movable jaws is disclosed in U.S. Pat. No. 6,360,577 to Austin. The crimping device uses an inclined plane that forces the jaws to move from an open position to a closed position. A major disadvantage is that the length of the inclined plane is given by the full circle (360°) divided by the number of jaws activated. Long inclined planes are preferred to reduce circumferential resistance or friction, but in order to achieve a smooth hole for crimping the stent, a large number of jaws is required, which means shorter inclined planes, less leverage and higher friction. Therefore, the effectiveness of this type of device is essentially limited and is only practical for stents having a diameter of 1.5 to 4.0 mm in their expanded size.

[0005] In recent years, various artificial valves have been developed, in which the valve structure is mounted on a stent and then delivered to the treatment site by percutaneous catheterization techniques. The diameter of the artificial valve is generally much larger than that of the coronary stent. Although the typical expanded coronary stent diameter is only 1.5 to 4.0 mm, the diameter of the stented artificial valve will generally be in the range of about 19 to 29 mm, at least 5 times larger.

[0006] Another difference is that the coronary stent is a stand-alone metal device that can be crimped onto the balloon prior to packaging. For an artificial valve, the stent acts as a support frame to hold the valve structure, which is typically made of a biological material (such as a pericardial valve or a harvested valve). In order to have improved function after deployment, it is generally desirable to package such a valve in an open (i.e., expanded) state in a preservation fluid. Therefore, it is necessary to crimp the valve in the operating room a few minutes before implantation, thereby eliminating pre-crimping on the balloon by the manufacturer.

[0007] Due to the unique crimping requirements of stent-based prosthetic valves, it has been found that existing crimping devices configured for use with coronary stents are not suitable for use with stent-based prosthetic valves. In addition, as described above, existing crimping mechanisms suffer from various disadvantages that limit their suitability for use with stent-based prosthetic valves. Due to the deficiencies associated with existing crimping techniques, a new crimping device is described in co-owned U.S. Patent No. 6,730,118 to Spenser et al., which relates to a crimping device suitable for crimping a prosthetic valve as part of an implantation procedure.

[0008] Another version of an artificial heart valve crimper is sold by MachineSolutions Inc. of Flagstaff, Arizona. The HV200 is a disposable crimper that uses multiple pivoting segments to crimp a percutaneous heart valve. The Machine Solutions crimper is also disclosed in two U.S. Patents Nos. 6,629,350 and 6,925,847 to Motsenbocker. These crimping devices are based on segments that rotate around a pivot pin to produce radial compression. Unfortunately, the pivoting design tends to concentrate stress in certain areas of the various segments and in the mechanism used to pivot the segments. Moreover, the user must apply significant force to close the crimper hole around a relatively large percutaneous heart valve.

[0009] US Patent No. 7,530,253 discloses a crimping mechanism for a prosthetic heart valve having linearly movable jaws capable of crimping a relatively large sized valve to a small delivery size but also relatively large size.

[0010] Although the heart valve crimping technology available to date provides an improvement over existing stent crimper technology, it has been found that there is still a need for a more effective device. It is desirable that such a device be able to crimp a valve from a diameter of about 29 mm to a crimped size of about 6 mm without requiring excessive force and without causing high mechanical stresses within the device. It is also desirable that such a device be simple to use and relatively inexpensive to manufacture. It is also desirable that such a device be sterile and suitable for manual manipulation in a catheterization laboratory or operating room. The present invention addresses this need. Summary of the invention

[0011] The present invention provides a method and apparatus for curling an expandable artificial heart valve having a support frame and a stent. The curling mechanism includes a plurality of jaws configured for coordinated inward movement toward a curling axis to reduce the size of the curled iris around the stented valve. A rotating cam acts on the jaws and displaces them inward. A plurality of Cartesian guide elements cooperate with the jaws to distribute force within the curling mechanism. The guide elements are located between the curling jaws and the outer shell and are constrained by the outer shell to move along a line tangential to a circle centered on the curling axis. The guide elements engage at least some of the curling jaws, while the remaining curling jaws are meshed and engaged for synchronous movement. The actuating mechanism includes a lead screw, a carriage assembly, and a connecting rod for rotating the cam with considerable torque.

[0012] In one embodiment, a prosthetic valve crimping device capable of reducing the diameter of an expandable prosthetic stented valve includes a plurality of crimping jaws meshingly engaged and arranged circumferentially around a crimping orifice having a central crimping axis, each of the crimping jaws having an inner crimping wedge. A rotating cam acts on the crimping jaws and displaces them generally radially inward, while a stationary outer housing contains the cam and the crimping jaws. Finally, a plurality of guide elements are each constrained by a fixed groove in the outer housing to move between a first position and a second position along a line tangential to a circle around the central axis, wherein the guide elements move at least some of the crimping jaws along the line so that all of the crimping wedges of the crimping jaws translate inwardly along a radial line toward the crimping axis.

[0013] In one aspect, the crimping wedge is made of a different material than the rest of the crimping jaws. The guide element may be a separate element from the crimping jaws. Preferably, the guide element is rigidly coupled to at least some of the crimping jaws by being integrally formed with or fastened to at least some of the crimping jaws.

[0014] Advantageously, the crimping jaws each include an assembly of a pair of travel blocks on the sides of a cam and one of the crimping wedges extending across a central aperture in the cam. The cam may include two plates having a spiral cam groove, the plates acting on a cam fixed to each side travel and extending axially inwardly into the cam groove. Furthermore, the cam plates may each have a cam rod extending radially outwardly therefrom, the cam rod being driven by a carriage assembly on the lead screw. Preferably, a link between the cam rod and the carriage assembly increases the torque applied to the cam when the carriage assembly reaches opposite ends of the lead screw.

[0015] In a second aspect, the present application discloses an artificial valve curling device capable of reducing the diameter of an expandable artificial stented valve. The device has a plurality of curling jaws that are meshed and arranged circumferentially around a curling orifice having a central curling axis, wherein each of the curling jaws includes a pair of spaced travel blocks and an assembly of radially inner curling wedges extending therebetween. A rotating cam acts on the curling jaws and displaces them generally radially inward, the cam including two disks having a spiral cam groove, the disk acting on a cam fixed to each side travel block and extending axially inward into the cam groove. A stationary outer shell contains the cam and the curling jaws, and a lower actuating mechanism including a coupled lead screw and carriage assembly to rotate the cam. A pair of travel blocks of at least some of the curling jaws are constrained by a fixed groove in the outer shell to move along a line tangential to a circle around the central axis so that all the curling wedges of the curling jaws translate inwardly toward the curling axis along a radial line.

[0016] In the device of the second aspect, the cam plates may each have a cam rod extending radially outward therefrom, the cam rod being driven by the carriage assembly on the lead screw via a connecting rod between the cam rod and the carriage assembly, the connecting rod increasing the torque applied to the cam when the carriage assembly reaches opposite ends of the lead screw. In addition, a drive motor may be provided to actuate the lead screw. Moreover, the crimping wedge may be made of a different material than the rest of the crimping jaws.

[0017] The device of the second aspect may further include a plurality of guide elements, each of which is constrained by a fixed groove in the outer shell to move between a first position and a second position along a line tangential to a circle around the central axis. The guide elements move at least some of the crimping jaws along the line so that all of the crimping wedges of the crimping jaws translate inwardly toward the crimping axis along a radial line.

[0018] In one embodiment, half the number of guide elements act as crimping jaws, so that some of the crimping jaws are driven and others are followers. Preferably, the guide element is rigidly connected to the travel block of one crimping jaw half by being integrally formed with or fastened to the one crimping jaw half.

[0019] In either aspect, each guide element may comprise a linear plate of irregular rhombus shape having four vertices and straight sides therebetween, with a notch on one side of one of the adjacent vertices, and one of the vertices of each linear plate fits snugly within the notch on the adjacent guide member when the guide element is displaced along the line to the second position, and such nested contact between all guide elements in this manner provides a positive stop to further inward movement of the curling mechanism. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1Ais a perspective view of an exemplary prosthetic heart valve having an expandable support frame and a plurality of flexible leaflets therein;

[0021] Figure 1B is crimped around the balloon catheter to a reduced diameter Figure 1A Side view of a prosthetic heart valve;

[0022] Figure 2A and Figure 2B is a partial cross-sectional view of the curling mechanism of the present application in both an open curling jaw position and a closed curling jaw position;

[0023] Figure 3A is an exploded perspective view showing components of an exemplary crimping mechanism;

[0024] Figure 3B is a partially exploded perspective view of an exemplary crimping mechanism with an assembled movable crimping jaw assembly, and Figure 3C is a perspective view of an exemplary cam forming part of a crimping jaw assembly;

[0025] Figure 4 is a front view of a central cam forming part of a movable crimping jaw assembly;

[0026] Figure 5A and Figure 5B is a different perspective view of one of the crimping jaws showing the inner cam follower, and Figure 5C It is a front view;

[0027] Figure 6 is a perspective view of a movable crimping jaw assembly including a cam, a crimping jaw, and a plurality of Cartesian guide elements;

[0028] Fig. 7A and Figure 7B is a front view of the inner crimping mechanism in both an open crimping jaw position and a closed crimping jaw position, showing a center cam and crimping jaws assembled on the inner crimping mechanism;

[0029] Figure 8 is a front view of the inner face of one half of the outer shell of an exemplary crimping mechanism showing fixed guide channels on the inner face;

[0030] Fig.9A So with in with Figure 8 The outer housing of the curling mechanism interacts with a view of multiple Cartesian guide elements arranged in space in the same manner, while Fig. 9B is a perspective view of a single Cartesian guide element;

[0031] Fig. 10Ais a front view of the inner face of the outer housing of the crimping mechanism showing the position of the guide element on the inner face when in the radially outward position, and Fig. 10B is a similar view showing the guide element in a radially inward position;

[0032] Fig.11A and Fig. 11B is similar to Fig. 7A and Figure 7B and also showing a guide element interacting with the crimping jaws;

[0033] Fig. 11C and Fig.11D yes Fig.11A and Fig. 11B A partial cross-sectional view of FIG. 1 showing the interaction of only one guide element with three crimped jaws;

[0034] Fig.11E Place one of the center jaws of the crimping jaws into Fig. 11C and Fig.11D Separate to show their relative and absolute motion;

[0035] Fig. 12A and Fig. 12B is a schematic perspective view of an alternative embodiment of the crimping mechanism of the present application in both an open crimping jaw position and a closed crimping jaw position, which crimping mechanism is very similar to Figure 1A-11E The crimping mechanism in but with a modified guide element;

[0036] Figures 13A-13C are several views of another embodiment of the curling mechanism of the present application, which is similar to Figure 1A-12B The crimping mechanism shown in but with fewer guiding elements;

[0037] Figures 14A-14C is in both the open crimped jaw position and the closed crimped jaw position Figures 13A-13C A partial front view of the curling mechanism;

[0038] Figures 15A-15B is a front view of yet another crimping mechanism of the present application, the crimping mechanism using a compressible sleeve, shown in both an open state and a crimped state;

[0039] Figures 16A-16B is a front view of a crimping mechanism with a compressible sleeve with the front cover removed to show the Fig.15A and Fig. 15B The internal parts in the position;

[0040] Fig.17 is an exploded view of a crimping mechanism having compressible jaws;

[0041] Fig.18 is a cutaway perspective view of a crimping mechanism having compressible jaws;

[0042] Figures 19A-19B is a cutaway perspective view of a crimping mechanism having compressible jaws showing movement of a compression assembly;

[0043] Figures 20A-20C are perspective and cross-sectional views of a series of crimping mechanisms of progressively larger sizes, each crimping mechanism having a compressible jaw;

[0044] Figures 21A-21B is a schematic front view of yet another crimping mechanism of the present application, the crimping mechanism using compressible jaws; and

[0045] Fig.22A is a perspective view of an alternative crimping mechanism having a modified actuation mechanism and outer housing shown in phantom, and Fig. 22B The crimping mechanism is shown from different views and without the outer housing, and Fig. 22C Several internal components are shown including an exploded crimping jaw. DETAILED DESCRIPTION

[0046] The present invention provides an improved crimper for a stent or artificial valve. The particularly advantageous features of the present crimper enable the diameter of a relatively large stent or artificial valve to be reduced in combination with a small size crimper that produces a high crimping force to result in a small final diameter. The crimper is particularly suitable for crimping artificial heart valves that have a significantly larger expansion diameter than most stents currently in use. According to Chessa et al., the Palmaz-Genesis XD stent (Cordis J&J Interventional Systems Co.) is designed for an expansion range of 10-18 mm and is considered a large or ultra-large stent (see "Results and Mid-long-term Follow-up of Stent Implantation for Native and Recurrent Coarctation of the Aorta", published online on September 26, 2005 in the European Heart Journal, Vol. 26, No. 24, pp. 2728-2732). The most commonly used stents are significantly smaller, ranging from 3-6 mm. Crimpers used for these stents have proven inadequate to reduce the size of even larger artificial valves (e.g., stented artificial heart valves). In contrast, aspects of the present crimper may also be applicable to crimping stents, but certain features described herein also make it particularly suitable for crimping large diameter stents, stent grafts, and artificial valves.

[0047] The term "stented valve" as used herein refers to an artificial valve for implantation, primarily an artificial heart valve, but venous valves and the like are also contemplated. A stented valve has a support frame or stent that provides the primary structural support in its expanded state. Such a support frame is typically tubular when expanded and may be expanded using a balloon or due to their own inherent elasticity (i.e., self-expanding) or by mechanical means. Figure 1A and Figure 1B An exemplary stented valve is shown, but the present invention may also be used to crimp other such prosthetic valves.

[0048] Figure 1A An exemplary balloon expandable prosthetic heart valve 20 is shown having an inflow end 22 and an outflow end 24. The valve includes an outer stent or support frame 26 that supports a plurality of flexible leaflets 28 therein. Figure 1A The valve 20 is shown in its expanded or operated shape, wherein the support frame 26 generally defines a diametrical region having a diameter D max The valve 20 is a cylindrical tube with three leaflets 28 attached to the support frame extending into the cylindrical space defined therein to be connected to each other. In the exemplary valve 20, the three separate leaflets 28 are each fixed to the support frame 26 and fixed to the other two leaflets along their adjacent lines or commissures. Of course, an entire bioprosthetic valve, such as a porcine valve, may also be used. In this sense, "leaflet" refers to a separate leaflet or a leaflet within an entire xenotransplant valve.

[0049] Figure 1B The valve 20 is shown mounted on the balloon 30 prior to inflation. The crimped outer diameter of the valve 20 is denoted by D min The balloon 30 is typically mounted on the end of a catheter 32 which is guided over a steerable wire 34 to the implantation site.

[0050] More details about similar types of exemplary prosthetic heart valves can be found in U.S. Patent No. 6,730,118 and U.S. Patent Publication No. 2014 / 0343671, which are expressly incorporated herein by reference. In addition, the VEGA® ... The Heart Valve family is a balloon expandable prosthetic heart valve of similar properties, the construction of which is also expressly incorporated herein by reference.

[0051] U.S. Patent No. 7,530,253 (expressly incorporated herein by reference) discloses a crimping mechanism for a prosthetic heart valve having the ability to crimp a relatively large sized valve to a small delivery size. However, due to the need to generate a high leverage force to crimp a large diameter valve, the mechanism in the '253 patent is relatively large. In contrast, the crimper mechanism disclosed herein uses a Cartesian movement guide element to generate radial jaw motion close to a central orifice. As a result, the size of the crimping jaws is significantly reduced, and the stiffness of the jaws (or the ability to withstand higher crimping forces) is increased.

[0052] The crimper mechanism of the present invention effectively reduces the size of the artificial valve from up to 30 mm (D max ) down to 6mm(D min ). Artificial heart valve sizes typically range anywhere from 20 mm up to about 30 mm. Therefore, the minimum amount of size reduction is about 14 mm, and the maximum amount is about 24 mm. In comparison, a typical coronary stent has an expanded diameter of between about 3-6 mm, and is crimped to a minimum diameter of between about 1.5-2 mm for a total maximum size reduction of about 4 mm. To distinguish itself from conventional stent crimpers, the present invention provides a diameter reduction of at least 10 mm, and preferably at least 20 mm. Because the diametrically opposed jaws act relative to each other to reduce the size of the artificial valve, each jaw crimps the valve half the distance of the total diameter reduction. This means that each jaw moves radially inward by at least 5 mm, and more preferably at least 10 mm.

[0053] Reference now Figure 2A and Figure 2B , which shows a preferred embodiment of an improved artificial heart valve crimping mechanism 40. The crimping mechanism 40 includes an outer shell 42 that encloses a plurality of crimping jaws 44 arranged around a central crimping axis 46. As will be described, there are preferably 12 crimping jaws 44, but other numbers of jaws are possible. The jaws 44 are initially Figure 2A 48 is shown retracted outwardly so as not to be visible within the receiving aperture 48, which is sized to be large enough to accommodate a Figure 1B A dilated heart valve 20 is shown. Figure 2B The crimping jaws 44 are shown displaced radially inwardly in a coordinated manner to form a crimping iris 50 defined by the combined inner surfaces of the jaw assembly. The crimping iris 50 has a minimum diameter small enough to fully crimp the heart valve 20 onto the balloon 30. Although not shown, the crimping operation includes placing the expanded heart valve 20 around the balloon 30 before inserting the assembly into the orifice 48 and actuating the crimping jaws 44.

[0054] exist Figure 2A and Figure 2BThe lower portion of the outer housing 42 is cut away to expose a portion of the actuating mechanism therein. Specifically, a relatively large diameter, horizontally oriented lead screw 52 is journaled so as to rotate on either side of the housing 42 and perpendicular to the curling axis 46. Although not shown, it is desirable that a motor in the lower portion of the housing 42 is connected via a power transmission device to drive the lead screw 52 and increase the applied force. Alternatively, one or both ends of the lead screw 52 extend outwardly from the housing 42 and terminate in a nut or other such keyed element. The lead screw can be manually rotated about its axis by inserting a crank or key into one end of the lead screw 52. An internally threaded carriage 54 travels back and forth along the lead screw 52 as the lead screw 52 rotates. The carriage 54 is characterized by a short shaft 56 extending from one side, which is retained in a cam 62 (see Figure 3A and Figure 3B ) in the large slot 58 in the lever arm 60, thereby preventing the slide from rotating with the screw.

[0055] Further details of the interaction between the cam 62 and the crimping jaw 44 will be explained more fully below. Figure 2A and Figure 2B As shown, rotation of the lead screw 52 causes the carriage 54 to travel from right to left, which in turn interacts with the lever arm slot 58 and causes the cam 62 to rotate clockwise (CW). Rotating the cam 62 in this manner causes the jaws 44 to shift from their radially outward positions to their radially inward positions, thereby crimping the heart valve 20.

[0056] Figure 3A is an exploded perspective view showing the internal components of the exemplary crimping mechanism 40. The outer housing 42 includes two molded halves that together provide a bearing seat for the lead screw 52. Although the inner face of only one of the two housing halves is shown, both housing halves include a plurality of linear guide channels 64 molded into their inner faces and arranged in a spoke-like manner tangentially around the receiving aperture 48. The two halves of the outer housing 42 sandwich a crimping jaw assembly 66 therebetween.

[0057] Figure 3B is a partially exploded perspective view of the crimping mechanism 20, showing a crimping jaw assembly 66 and one half of the outer housing 42 with its guide channel 64. The crimping jaw assembly 66 has a generally cylindrical profile that fits tightly within the similarly shaped upper portion of the outer housing 42 and is centered along the crimping axis 46. In addition to the lead screw 52 and the carriage 54, the crimping jaw assembly 66 is also composed of the moving parts within the crimping mechanism 40. Also refer to Figure 3A, the crimping jaw assembly 66 comprises an axial sandwich of elements, in the middle of which is the cam 62. The crimping jaw 44 is located on the side of the cam 62, and a plurality of Cartesian guide elements 70 are arranged on the outside of the crimping jaw 44. In turn, the crimping jaw assembly 66 is firmly located within the two halves of the housing 42, but can also rotate therein.

[0058] In order to understand the interaction between the moving parts of the crimping jaw assembly 66, one must start at the cam 62 and move axially outward. The cam 62 is rotated by the lead screw 52 and the carriage 54, thereby forming the prime mover of the crimping jaw assembly 66. Generally, the rotation of the cam 62 initiates the movement of all other parts, but, as will be described below, the physical interaction and guided contact between the parts creates additional reaction forces that distribute the force from the cam.

[0059] Figure 3C 6 is a perspective view of an exemplary cam 62 including a pair of parallel annular disks 72 connected at their inner circular edges by an annular hub 74. A plurality of axially oriented rollers 76 are journaled for rotation between the two disks 72 and are circumferentially distributed in an annular space 78 defined radially outside the hub 74. Each roller 76 projects slightly outwardly from the outer edge of the disk 72 so as to contact the outer housing 42 for rotation therein and to provide stability for the crimping operation. Figure 4 As shown, each annular disk 72 includes a series of arcuate cam grooves 80 formed therein, and the arcuate cam grooves generally curve from their radial inner sides to their radial outer edges. Each cam groove 80 is curved so as to protrude radially outward. The arcuate cam grooves 80 on the two disks 72 are aligned and have the same shape, so that the cam grooves 80 are in a clockwise (CW) direction (i.e., when looking at the outside of one disk). Figure 4 ) extends radially outward, while the slots extend radially outward in a counterclockwise (CCW) direction when looking toward the outside of the other disk.

[0060] In the embodiment shown, there are twelve cam slots 80 nested relatively closely to each other around each disk 72. Each two aligned slots 80 in two disks 72 act on one jaw 44, and thus in the preferred embodiment there are twelve jaws 44. It should be understood that the number of crimping jaws 44, and thus the number of cam slots 80, can be modified, but the number is preferably between 8-16.

[0061] like Figures 5A-5C As shown, each crimp jaw 44 includes a radially inner crimp wedge 82 connecting a pair of axially spaced, generally triangular shaped outer travel blocks 84 . Figure 5CThe front view of FIG. 6 shows that the travel blocks each span an angle θ, which varies depending on the number of jaws 44 used and is preferably 30° in the case of 12 jaws. When the jaws 44 are assembled with the cam 62, as shown Figure 6 As shown, the jaws 44 are in their radially outward position and the crimping wedge 82 is positioned within a central aperture defined within the annular hub 74 of the cam 62. The inner surface of the crimping wedge 82 defines the above-mentioned iris 50 of the crimping mechanism 40. The travel block 84 of each jaw 44 is closely located to the side of the annular disk 72 of the cam 62, and a small cam follower 86 extending axially inward from each block is inserted into the arcuate cam groove 80. Each cam follower 86 has a generally circular configuration and is angled in a manner that is aligned with a tangent to the curve of the arcuate cam groove 80. The cam follower 86 is sized to be slightly smaller than the width of the cam groove 80 and can be made of a lubricating material such as nylon or Teflon to facilitate sliding in the cam groove. The cam follower 86 is located at the radially outer extent of each travel block 84.

[0062] At this stage, further explanation about materials is relevant. Many components are molded from a suitable polymer, such as the outer housing 42 and cam 62. The lead screw 52, ​​carriage 54 and of course the motor components are preferably metal, but some may also be polymers. The crimping jaw 44 may be a molded polymer, but it is desirable that the inner crimping wedge 82 that contacts the item being crimped is a material having high strength and high stiffness and low friction, such as reinforced nylon. In this regard, the inner crimping wedge 82 may be an insert for the larger jaw 44. Likewise, as described above, the cam follower 86 is preferably rigid and low friction, such as nylon. Of course, there are alternatives, and these are merely exemplary materials.

[0063] It will therefore be apparent that rotation of the cam 62 causes radially inward movement of the crimping jaws 74 due to the interaction between the arcuate cam slot 80 and the cam follower 86 . Fig. 7A and Figure 7B is a front view of the inner crimping mechanism 40 in both the open crimping jaw position and the closed crimping jaw position, showing the central cam 62 and the crimping jaws 44 assembled thereon. Only one arcuate cam slot 80 and the mating cam follower 86 on one jaw 44 are shown in phantom. It should be understood that there are two cam slots 80 and two cam followers 86 associated with each jaw 44, although only one of each is shown. The jaw 44 on which the cam follower 86 is shown is highlighted by extending the phantom line along the corresponding angled edges to form angles α and β with the horizontal.

[0064] Fig. 7A and Figure 7BThe lever arm 60 of the cam 62 is shown rotating in a clockwise (CW) direction such that the cam follower 86 on each jaw 44 is acted upon by the arcuate cam groove 80. Because the cam groove 80 curves radially inward as the wheel 62 rotates clockwise, a radially inward cam force is transmitted to the cam follower 86. Due to the sliding interaction between the jaws 44, the inward movement of all jaws 44 from their rigid connection to their respective cam followers 86 is the same. It should be noted that the highlighted curled jaw 44 maintains the same rotational orientation as it translates radially inward and downward. That is, the angles α and β describing the orientation of the jaw 44 relative to horizontal remain the same. This is true for all jaws 44. Due to this movement, the inner surface of the curled wedge 82 defines a radially contracted iris 50. In addition, although the absolute angles of tangents drawn relative to the curvature of the arcuate groove 80 vary from one end of the groove to the other, the orientation of the cam followers 86 remains parallel to these tangents due to the movement of the respective jaws 44. This facilitates sliding movement of the cam follower 86 within the slot 80 .

[0065] The crimping jaws 44 have mating sliding surfaces so that they all move together with the same degree of translation as each other, albeit along different angles. In particular, each angled edge of the travel block 84 mates with an adjacent travel block edge in a tongue-and-groove manner. Return to Reference Figure 5A and Figure 5B Each travel block 84 has a slide rail 88 that cooperates with an oppositely oriented slide rail on the travel block 84 on the adjacent jaw 44. Figure 6 The sliding engagement of the track 88 helps prevent binding between the jaws 44 as they move inwardly together.

[0066] Furthermore, the starting position of the crimping jaws 44 and the angle of the edge of the travel block 84 cause the assembly of jaws to rotate as they cam inwardly. Essentially, each crimping jaw slides inwardly relative to one of its adjacent crimping jaws, and Figure 7B The resulting displacement shape seen in is somewhat similar to a windmill. The reader will also see Fig. 7A and Figure 7B As can be seen from the comparison of , the protruding curled jaw 44 translates radially inwardly and downwardly, which is equivalent to its clockwise rotation.

[0067] like Figures 5A-5C As shown, the crimping jaw 44 also has linear guide grooves 90 on the outer faces of the two travel blocks 84. These guide grooves 90 interact with the above-mentioned Cartesian guide elements 70, as will be described below. Figure 5C The guide groove 90 of each jaw 44 divides the jaw angle θ into two.

[0068] Figure 84 is a front view of the interior face of one half of the outer housing 42, showing the fixed guide channels 64. As described above, the guide channels 64 are tangential to the central aperture 48 in the housing 42. The guide channels 64 preferably include axial depressions in the outer plate 92 of the housing 42, wherein the housing half including the guide channels is desirably injection molded. The radially inner end of each guide channel 64 merges with the adjacent guide channel at its approximately midpoint. Because there are six guide channels 64 equally spaced and evenly oriented about the aperture 48, the inner portion of the guide channels defines the vertices of a hexagon that closely surrounds the aperture. Each guide channel 64 extends from a vertex of the hexagon beyond its tangent point to the aperture 48 and outwardly to the outer edge 94 of the housing 48. The guide channels 64 interact with the Cartesian guide element 70, as will be described below. The number of guide channels depends on the number of jaws; i.e., half the number of jaws.

[0069] Fig.9A A plurality of Cartesian guide elements 70 are shown which are arranged in space in the same manner as when interacting with the outer housing 42, Fig. 9B A separate individual Cartesian guide element 70 is shown, while Fig. 10A and Fig. 10B The guide elements are superimposed over the outer housing and the channel 64. Each guide element 70 includes an angled, generally flat, linear plate 96 having raised linear rods 98a, 98b extending from opposing inner and outer faces. The opposing linear rods 98a, 98b are oriented perpendicular to each other and thus together define a right angle intersection, albeit on opposite faces of the guide element 70. The outer face of the guide element 70 abuts the outer plate of the housing 42 so that the outer linear rods 98a on that side fit tightly within the fixed guide channel 64. On the inner face, the guide element 70 contacts the assembly of the crimping jaws 44 and the inner linear rods 98b fit tightly within the guide slots 90 on the six guide elements. Because the outer linear rods 98a are constrained within the guide channel 64, the guide element 70 is also constrained to move linearly between a first position and a second position parallel to the guide channel.

[0070] Fig. 10A shows that when in the radially outward position (also in Fig.9A The outer linear rod 98a extends within and is guided by the guide channel 64 as described above. In this starting position, the radially outer edges of the linear plates 96 are close to the outer edge 94 of the housing 42, and their radially inner edges are positioned just outside the central aperture 48. Fig. 10B9 is a similar view showing the guide elements 70 in a radially inward position. The outer linear rods 98a slide inwardly along the guide channels 64, and the linear plates 96 fit closely together. The linear plates 96 define an irregular diamond shape having generally four vertices within the outer extent of the intersecting linear rods 98a, 98b. Straight edges extend between the vertices, and there is a notch 100 on one side near one vertex. When the guide elements 70 are in their radially inward position, one vertex in each guide element fits closely within the next notch 100, and in this manner the nested contact between all guide elements 70 provides a positive stop upon further inward movement of the crimping mechanism 40.

[0071] Fig.11A and Fig. 11B is similar to Fig. 7A and Figure 7B , with the crimp jaw assembly 66 in place, and showing the Cartesian guide members 70 interacting with the crimp jaws 44. The guide members 70 are referred to as "Cartesian" because of the opposing intersecting linear bars 98a, 98b on each guide member. That is, as described above, the guide members 70 are constrained to move linearly along the guide channel 64 in the outer housing 42. At the same time, the interaction between the inner linear bars 98b on each member 70 and the guide slots 90 on each of the other crimp jaws 44 constrains those jaws to move in the direction of the associated guide member 70.

[0072] Before discussing this coordinated movement, it should be noted that there are only six guide members 70, and twelve crimping jaws 44. Fig.11A As shown, each guide member 70 interacts with each other crimping jaw 44. The six crimping jaws 44a that interact with the guide member 70 can be referred to as the leading jaws, while the six crimping jaws 44b that do not interact with the guide member are referred to as the driven jaws. However, it is important to remember that each crimping jaw 44 has a cam follower 86 thereon, and thus each crimping jaw is directly driven by the cam 62.

[0073] Reference again Fig.11A and Fig. 11C, Cartesian axes 102, 104 are superimposed on an assembly of the guide member 70 and its guide jaw 44a. The first axis 102 extends along the outer linear rod 98a on the guide member 70. The reader will understand that the outer linear rod 98a interacts with the guide channel 64 on the half of the outer shell that is not shown. Therefore, the guide member 70 is constrained to move linearly along the first axis 102. The second axis 104 extends along the inner linear rod 98b on the guide member 70, which corresponds to the guide groove 90 on the guide jaw 44a. The second axis 104 translates with the guide member 70, always remaining perpendicular to the first axis 102. Both the guide jaw 44a and the guide member 70 move together. This arrangement reduces friction losses and allows the guide jaw 44 and the guide element 70 to be selectively combined.

[0074] Now about Fig. 11B and Fig.11D , the cam 62 has rotated clockwise, causing sliding movement of all the curling jaws 44. When the leading jaw 44a begins to move inward, it is constrained to move along the first axis 102 with the corresponding guide member 70. Likewise, all six leading jaws 44 are constrained to move with their corresponding guide members 70. When each leading jaw 44a begins to move inward, it slides relative to one of the two adjacent driven jaws 44b. Of course, each driven jaw 44b is acted upon by two adjacent leading jaws 44a. Due to the angled sides of the adjacent jaws 44, as described above with reference to Fig. 7A and Figure 7B As explained, the assembly of jaws begins to rotate clockwise. The circumferential component of the motion of each guide jaw 44 transfers force through the guide slot 90 to the inner linear rod 98b on the guide member 70. This causes the guide member 70 to translate along the first axis 102.

[0075] It should be mentioned that providing two sets of force actuators (disc 72, travel block 84 and guide member 70) results in a symmetrical balanced system and reduced stress. Of course, a single disc 72 and associated crimping element is possible but requires a more robust structural design.

[0076] As guide member 70 and guide jaw 44a translate along first axis 102, they continue to move inwardly relative to outer housing 42. Of course, although they are not in direct contact with guide member 70, driven jaws 44b move in a similar manner because they are also acted upon by cam 62 and from symmetrical and mating edge contact between the jaws. Fig.11E The central jaw of the guided crimping jaw 44a is aligned with the Fig. 11C and Fig.11DThe cam 62 is isolated and shows the absolute movement 106 of the jaws along the first axis 102. Continued rotation of the cam 62 eventually moves the crimping jaws 44 to Figure 7B and Fig. 11B It is also noteworthy that the tip of the curling wedge 82 on each jaw translates radially inwardly along radial line 110 through the central curling axis 46 (see Fig.11A ). That is, the compound motion 106 is parallel to a radial line 110 passing through the crimping axis 46. This ensures uniform crimping of the stent or valve.

[0077] Relative movement of the mating components in the crimping mechanism 40 will occur regardless of whether an object is being crimped. Figure 1A When an object such as an expanded heart valve 20 is crimped, it exerts considerable resistance to the crimping mechanism 40. More specifically, the annular strength of the expanded heart valve 20 directly provides a radially outward reaction force 108 to the crimping wedge 82 of the jaws 44, such as Fig.11E shown.

[0078] Without the guide member 70, the mechanism is unbalanced and the reaction force 108 will tend to cause the jaw 44 to rotate. Furthermore, without the guide member 70, this reaction force will be translated through the curling jaw 44 to the cam follower 86, and therefore to the arcuate cam slot 80 of the cam 62. Although the cam slot 80 is relatively robust, the cam follower 86 is susceptible not only to stress deformation, but also to constraint. However, due to the contact between the guide member 70, the curling jaw 44 and the fixed outer housing 42, the reaction force from the curling process is transferred and distributed, so that the stress on the cam follower 86 is reduced. In particular, the Cartesian guide member 70 absorbs a considerable amount of the stress and provides an effective mating member for the curling jaw 44. About Fig.11E , the radially outward reaction force 108 from the crimping process is converted into a torque on the crimping jaw 44a. This torque is primarily resisted by the rigid constraint imposed by the outer housing guide channel 64 on the guide member 70 to move along the first axis 102. More specifically, due to the interaction between the guide slot 90 and the inner linear rod 98b, the clockwise torque on the guide jaw 44a will translate directly to the corresponding guide member 70, and because the guide member 70 is rotationally fixed relative to the outer housing 42, this rotational torque is resisted by the guide member 70.

[0079] One benefit over previous crimpers is the smaller mechanism size (approximately 1 / 2 the size of current crimpers) and the ability to operate at high crimping forces (small and stiff crimping jaws). The jaws 44 are displaced substantially radially using a Cartesian guide element 70 positioned proximate the central orifice 46. This guiding concept enables a significant reduction in the size of the crimping jaws 44 and an increase in the stiffness of the jaws (or the ability to withstand higher crimping forces). The radial alignment mechanism provided by the guide element 70 is based on a steep angular motion that is converted into a radial force applied proximate the central crimping axis. The guide element 70 converts the angular motion from the cam 62 into a radial force by substantially separating the angular motion into a Cartesian motion. In this motion, the jaws 44 move radially similar to previous crimpers, and the guide element 70 moves with them in the tangential housing channel 64.

[0080] In a preferred embodiment, the width of the crimping mechanism 40 or the approximate diameter of the cam 62 is about 80 mm. The overall height of the crimping mechanism 40 (such as Figure 2A , which includes the cam 62 and associated actuator located above the lead screw 52) is approximately 115 mm. Of course, these exemplary dimensions are used to enable the use of, for example, Figure 1A The balloon expandable prosthetic heart valve 20 is shown crimped to Figure 1B The mechanism must be robust enough to move the stainless steel support frame of the heart valve 20 from, for example, 30 mm (D max ) compressed to 6mm(D min ). A less rigid frame or a smaller size reduction may enable a further reduction in size of the crimper, and conversely, a larger size reduction may require a larger crimper.

[0081] Fig. 12A and Fig. 12B Schematic perspective views of an alternative embodiment of a crimping mechanism 120 in both an open position and a closed position of a crimping jaw 122, respectively. The entire crimping mechanism 120 is not shown, but is similar to the crimping mechanism shown in Figures 1-11. The main difference in the crimping mechanism 120 is the modification of the guide member 124. That is, instead of having a diamond-shaped plate with opposing crossed linear bars as previously described, the guide member 124 is a simple vertical bar attached together. The inner bar will extend within a guide slot 126 in the crimping jaw 122, while the outer bar will slide within a fixed guide channel in the outer housing (not shown). In all other respects, the crimping mechanism 120 works in the same manner as described above.

[0082] Figures 13A-13C and Figures 14A-14C Shows something like Figure 1A-12BAnother crimping mechanism 140 is shown with the crimping mechanism shown but with fewer guide elements 142. The guide elements 142 are simple crossed linear rods, as described above with reference to Fig. 12A and Fig. 12B Furthermore, there are still twelve crimping jaws 144. However, compared to the previous embodiment, there are only two guide elements 142. Figures 14A-14C The operation of the illustrated crimping mechanism 140 is similar to that described above, with the lead screw 146 turning a cam (not shown) which initiates the inward movement of the crimping jaws 144. Since the crimping jaws 144 are all connected in a tongue-and-groove manner as described above, they will move in and out synchronously even without the guide elements 142. The guide elements 142 only engage two of the crimping jaws 144, but still provide stress reduction and distributed application of force. Two guide elements 142 are considered to be a minimum, and three, four, or six are contemplated for a twelve-jaw mechanism. In the illustrated embodiment, the practical maximum number of guide elements 142 is six, or half the number of jaws. This allows the guide elements 142 to not interfere with each other as they slide back and forth.

[0083] Figures 15A-15B Yet another crimping mechanism 160 of the present application is schematically depicted, which utilizes a compressible sleeve (eg, a soft elastomer) rather than a plurality of separate jaws. Figures 16A-16B is a front view of the curling mechanism 160 with the front cover removed to show Fig.15A and Fig. 15B The curling mechanism 160 is characterized by a cam 162 that rotates within a pair of end plates 164 (only one is shown). The end plates 164 are fixed to a housing 166, within which an actuating mechanism is disposed that is very similar to the lead screw assembly described above.

[0084] The compressible sleeve 168 is rotationally retained between the end plates 164 and comprises an annular elastic sleeve having an outer axial groove. Fig. 15B and Fig. 16B As shown, the internal cavity or aperture 170 defined by the sleeve 168 contracts to a smaller sized aperture 170' upon rotation of the cam 162.

[0085] refer to Figures 16A-16B as well as Figure 17-19B , a plurality of link plates 172 are arranged to move in unison within the cam 162. More specifically, the outer ends 174 of the plates 172 are journaled for rotation in corresponding holes 180 around the outer periphery of the cam 162. The cam 162 may have a short section of gear teeth 176 on its lower edge that can be engaged by a rack, lead screw, or other such transmission within the moving housing 166.

[0086] Fig.17The crimping mechanism 160 is shown exploded. The link plate 172 and the mating compression plate 178 (see Figures 19A-19B ) includes at least 12 and preferably at least 24 connecting plates. The array 182 is arranged in the cam 162, which includes two series of peripheral holes 180 in which the two outer ends 174 of each link plate 172 are journaled for rotation. In this way, the symmetry reduces any possible misalignment forces during crimping of the artificial heart valve. Each end plate 164 has a central orifice through which the artificial heart valve enters the middle of the crimping mechanism 160, and an array of radial slots 186, which will be described below.

[0087] like Figures 19A-19B As best shown in the cross-sectional view of FIG. 1 , each link plate 172 is hinged on an inner end to a compression plate 178. The inner end of each compression plate 178 engages one of the axially oriented grooves 179 around the outer side of the compressible sleeve 168. The compression plate 178 is formed with two outer tracks 188 that slide within radial slots 186 formed in the end plate 164. Rotation of the cam 162 displaces the outer ends 174 of the link plates 172 so that they are displaced from the outer ends 174 of the end plates 164. Fig.16A The angled orientation shown transitions to Fig. 16B Because the inner end of the link plate 172 is hinged to the compression plate 178, the compression plate 178 is pushed radially inward. The engagement between the outer track 188 and the slot 186 constrains the compression plate 178 to move radially. The connecting plates 172, 178 surrounding the sleeve 168 thus push inward on the groove 179 and radially compress the sleeve to reduce the center aperture diameter.

[0088] Although the crimping mechanism 160 represents a superior solution, in that a single crimping "jaw" reduces the number of moving parts and associated friction, the size of the crimp is limited, and a series of similar crimpers may be required to reduce the size of the article in stages. Of course, if only a small amount of crimping is required, then a single crimping mechanism would be suitable.

[0089] Figures 20A-20C 2 are perspective and cross-sectional views of a multi-stage crimper 200 in which an outer housing 202 surrounds a series of progressively larger crimping mechanisms 204a, 204b, 204c, each having a compressible "jaw." The crimping apertures 206a, 206b, 206c for the three crimping mechanisms progressively reduce the size of a prosthetic device such as the artificial heart valve described above. Fig. 20BThe front cover of the housing 202 is shown removed to show one rotating cam 210 on the smallest curling mechanism 204a. The lower section of the gear teeth 212 on the cam 210 can be acted upon by a linearly displaced rack 214 to rotate the cam. Although not shown, larger curling mechanisms can also have similar cams acted upon simultaneously by a single rack 214. Fig. 20C The front portion of the cam 210 is shown removed to expose a plurality of connection plates 216, which may be the same as those described above with respect to Figures 15-19.

[0090] To crimp the prosthesis, it is first placed in the largest crimping mechanism 204c and the rack 214 is displaced to reduce the size of the prosthesis by a first amount. The rack 214 is returned to its original position and the prosthesis is then transferred to the middle crimping mechanism 204b and further reduced in size. Finally, the smallest crimping mechanism 204a reduces the size of the prosthesis to its final diameter. Although three crimping mechanisms are shown, a minimum of two stages and more than three stages may be used to sequentially crimp the prosthesis in this manner.

[0091] Figures 21A-21B Yet another crimping mechanism of the present application is schematically depicted, which utilizes a compressible jaw 260 (e.g., a soft elastomer). The jaws 260 are positioned between a series of spoke-like plates 262 that are initially angled radially so as to be nearly tangential to a circle defined by an inner face 264 of each compressible jaw 260. The outer face 266 of each jaw 260 is constrained so that they cannot expand radially outward. By rotating all of the spoke-like plates 262 together (e.g., Fig. 21B 264, the compressible jaws 260 are squeezed by the volume reduction between the plates 262, causing them to expand inwardly. The gathering of all interfaces 264 defines a curling iris and compresses any article within it. Again, with compressible jaws, the size of the curl is limited, and a series of similar crimpers can be used to reduce the size of the article in stages, as described above with respect to Figures 20A-20C Of course, if only a small amount of crimping is required, a single crimping mechanism would be suitable.

[0092] It should be understood that the internal components of the crimping mechanism described herein may be formed from a plurality of separate connected components, or by combining some of these components into a unitary member. Fig.11A and Fig. 11B The six guide jaws 44 seen in the figure are constrained to move with their respective guide members 70, so these components can be formed as a single piece. In contrast, certain elements can be divided into more than one piece, such as the jaws, to facilitate manufacturing. The latter case is achieved by Figures 22A-22C The curling mechanism shown in FIG.

[0093] Fig.22A is a perspective view of an alternative crimping mechanism 300 having a modified actuation mechanism and outer housing 302 shown in phantom. Fig. 22B The crimping mechanism 300 is shown from a different perspective and without the housing 302, and Fig. 22C Various internal components are shown including an exploded inner crimp wedge 306 .

[0094] The modified actuation mechanism is characterized by having a relatively large diameter horizontally oriented lead screw 310 that is journaled to rotate on either side of the housing 302 and perpendicular to the horizontal curling axis. A motor 312 in the lower portion of the housing 302 is desirably connected through a power transmission device (e.g., gears or pulleys 314) to drive the lead screw 310. Figure 2A-2B Compared to the actuation mechanism described above, rotation of the lead screw 310 results in translation of the carriage assembly 316, which is connected to the cam 318 via a link arm 320. That is, the link arm 320 is journaled for rotation at opposite ends, one end on the carriage assembly 316 and one end on the outer lever arm 322 of the cam 318. As with the previous embodiment, the cam 318 has two spaced-apart disks 324, each with a lever arm 322, and there are two link arms 320, one driving each lever arm. This provides an extremely balanced and robust drive system that prevents binding of the movable jaw components.

[0095] This linkage arrangement provides an extended actuation arm that produces a higher torque (linear translation to radial) at the end of the crimping process, where the greatest force is required. In other words, the stented prosthetic valve is easier to crimp at its larger diameter and becomes increasingly stiffer as it contracts. When the carriage assembly 316 reaches the end of the lead screw 310, the linkage arm 320 applies a large amount of torque to the cam 318 relative to each rotation of the lead screw.

[0096] Fig. 22C 318 and the jaw mechanism. The curling wedges 306 are shown arranged in a generally spiral array as they will be retained within the central opening 330 in the cam 318. The curling wedges 306 replace the above-mentioned Figure 1A-11E 4. The inner curled wedge 82 of the jaw 44 is depicted. Flanking each side of the cam 318 is a set of six generally triangular (disc-shaped) travel blocks 332 and six guide blocks 334. The guide blocks 334 basically include two back-to-back components: an inner travel block 336 similar to the travel block 332 and an outer guide element 338 similar to the Cartesian guide element 70 described above. Fig. 22B As shown, six travel blocks 332 and six guide blocks 334 are arranged with Figure 1A-11EThe guide element 338 has a linear bar 340 that slides in a fixed guide channel (not shown) in the inner face of the housing 302. Each of the disc-shaped travel blocks 332, 336 engages with the adjacent block in a tongue-and-groove manner to achieve smooth sliding movement therebetween.

[0097] The crimping jaw assembly of the crimping wedge 306, six travel blocks 332 and six guide blocks 334 is formed by a plurality of aligned through holes and bolts 342. As in earlier versions, a spiral cam groove 350 in the cam 318 moves a small cam pin 352 inwardly as the wheel rotates. The cam pin is held in a hole (not shown) on the inner face of each of the six travel blocks 332 and six guide blocks 334 so that the blocks are urged along a linear path constrained by a linear rod 340 that slides within a fixed guide channel of the housing 302. This is the same as described above. The end result is that the inner tip of the crimping wedge 306 translates inwardly along a radial line to uniformly crimp the stented valve therein.

[0098] Each crimping jaw itself comprises a combination of one of a crimping wedge 306 connected at both axial ends to a pair of travel blocks 332 or a pair of guide blocks 334. It will be appreciated that the several components may be manufactured separately from the same or different materials and then secured together via bolts 342 over and through cams 318. Preferably, the crimping wedge 306 is formed of a relatively rigid metal, or only the inner tip of the crimping wedge 306 may be metal. The slide may be metal or a hard plastic or resin.

[0099] The combination of previously separate components to form six guide blocks 334 illustrates an option of using fewer, more complex components, while Fig. 22C The exploded assembly of shows the option of using more, less complex parts. Ultimately, which configuration is chosen depends on materials, tooling costs, engineering difficulty, etc. In a preferred embodiment, the assembly including the wedge 306 plus two travel blocks 332 or two guide blocks 334 is formed as one piece, preferably defining twelve jaw assemblies.

[0100] The exemplary embodiments of the present invention have been described, but the present invention is not limited to these embodiments. Various modifications can be made without departing from the scope of the subject matter of the present invention read from the appended claims, the specification of the present invention, and the drawings.

Claims

1. A crimping system comprising: an artificial heart valve comprising a self-expanding frame and a plurality of leaflets within the frame, the artificial heart valve being radially contractible and expandable between an expanded configuration having a first diameter and a compressed configuration having a second diameter less than the first diameter; as well as A curling device for the artificial heart valve, the curling device comprising: a first shell half and a second shell half, the first shell half and the second shell half having a generally circular receiving aperture and a plurality of grooves around the periphery of the respective receiving apertures, the receiving apertures of the first shell half and the receiving apertures of the second shell half being spaced apart from each other and aligned with respect to a central axis passing through the center of each aperture; A cam comprising: a first annular disk and a second annular disk, the first annular disk and the second annular disk being spaced apart from each other and aligned with respect to the central axis, the first annular disk and the second annular disk having a plurality of arcuate cam grooves around the periphery of the central opening thereof, the first annular disk and the second annular disk defining a curling region between the central opening; and at least one lever arm, each lever arm extending radially outward from a respective one of the first annular disk and the second annular disk; An actuation assembly comprising: Lead screw; an internally threaded carriage engaged with the lead screw and the at least one lever arm of the cam; and A crimping assembly comprising: a plurality of guide curling jaws and driven curling jaws arrayed in a circumferential direction of the central opening of the first annular disk and the second annular disk, the guide curling jaws and driven curling jaws being meshingly engaged, each of the plurality of guide curling jaws and driven curling jaws comprising a pair of spaced travel blocks and a radially inner curling wedge extending therebetween, the curling wedges of the guide curling jaws and the driven curling jaws jointly defining a curling channel within the curling region, the curling channel being configured to accommodate the artificial heart valve in the expanded configuration therein, each leading crimping jaw engages the first housing half and the second housing half via a pair of guide members, one of the pair of guide members being disposed within a respective one of the recesses of the first housing half and the other of the pair of guide members being disposed within a respective one of the recesses of the second housing half, the guide members moving at least some of the leading crimping jaws and the driven crimping jaws along lines tangential to a circle about the central axis so that all crimping wedges in the leading crimping jaws and the driven crimping jaws translate inwardly toward the central axis along radial lines of the central opening, Each of the leading crimping jaw and the driven crimping jaw further engages the cam via a pair of cam followers, one of the pair of cam followers being disposed within a respective one of the cam grooves of the first annular disk and the other of the pair of cam followers being disposed within a respective one of the cam grooves of the second annular disk, wherein rotation of the lead screw causes movement of the carriage along the axis of the lead screw, movement of the carriage causing rotation of the cam via engagement with the at least one lever arm of the cam, wherein the rotation of the cam causes the leading crimping jaw and the following crimping jaw to move via engagement between the cam follower and respective cam grooves of the first and second annular disks, wherein the engagement between the guide member and the respective recesses of the first and second housing halves constrains movement of the guide crimping jaw due to the rotation of the cam, and wherein the movement of the leading crimping jaw and the driven crimping jaw changes the diameter of the crimping channel defined by the crimping wedge such that the prosthetic heart valve is radially compressed into the compressed configuration.

2. The crimping system of claim 1, wherein the engagement between the guide member and the corresponding groove constrains each crimping wedge to move only in a radial direction of the crimping region.

3. The crimping system according to claim 1, wherein: For each guide crimping jaw, the guide member and the cam follower are coupled to the guide crimping jaw.

4. The crimping system of claim 1, wherein the leading crimping jaw and the driven crimping jaw have cooperating sliding surfaces for meshing engagement.

5. The crimping system according to claim 1, wherein each of the travel blocks of the leading crimping jaw and the driven crimping jaw cooperates with an adjacent travel block in a tongue-and-groove manner.

6. The crimping system of claim 1, wherein: Each cam groove of the first annular disk and the second annular disk has an arc shape with one end thereof being closer to the corresponding central opening in the radial direction than the opposite end thereof, and Each groove of the first housing half and the second housing half has a substantially linear shape and one end thereof is closer to the corresponding accommodation aperture along the radial direction than an opposite end thereof.

7. The crimping system of claim 1, wherein: For each guide crimping jaw, at least one of the guide member and the cam follower includes a bolt extending through the guide crimping jaw in a direction parallel to the central axis.

8. The crimping system of claim 1, wherein the carriage includes at least one stub shaft that engages a corresponding opening in the at least one lever arm.

9. A curling system according to claim 1, wherein the screw extends substantially parallel to a direction perpendicular to the central axis, and the actuating assembly includes an actuating member connected to one end of the screw, the actuating member being disposed outside the first housing half and the second housing half and being configured for manual rotation of the screw.

10. The crimping system of claim 1, wherein: The difference between the first diameter in the expanded configuration and the second diameter in the compressed configuration is at least 14 mm.

11. A crimping system comprising: an artificial heart valve comprising a self-expanding frame and a plurality of leaflets within the frame, the artificial heart valve being radially contractible and expandable between an expanded configuration having a first diameter and a compressed configuration having a second diameter less than the first diameter; as well as A curling device for the artificial heart valve, the curling device comprising: a first housing half and a second housing half, each of the first housing half and the second housing half having a generally circular receiving aperture and a plurality of grooves around a periphery of the respective receiving aperture; A cam including a first annular disk and a second annular disk, the first annular disk and the second annular disk are spaced apart from each other and aligned with respect to a central axis, the first annular disk and the second annular disk each having a plurality of arc-shaped cam grooves around the periphery of a central opening thereof; an actuation assembly coupled to the cam and configured to rotate the cam about the central axis, wherein the actuation assembly includes a screw operatively coupled to the cam; and a crimping assembly coupled to the cam and comprising a plurality of crimping jaws disposed in a circumferential direction of the central openings of the first and second annular disks, the plurality of crimping jaws being in meshing engagement, each of the plurality of crimping jaws comprising a pair of spaced-apart travel blocks and a radially inner crimping wedge extending therebetween, the crimping wedges of the crimping jaws collectively defining at least a portion of a crimping channel configured to receive therein the prosthetic heart valve in the expanded configuration, wherein rotation of the screw causes rotation of the cam, which in turn causes the pair of travel blocks of at least some of the crimping jaws constrained by the grooves in the first and second housing halves to move along a line tangential to a circle around the central axis via cam followers disposed in respective cam grooves of the first and second annular disks, so that all crimping wedges of the crimping jaws translate inwardly toward the central axis along radial lines of the central opening, wherein the movement of each crimping jaw is constrained by a guide member disposed within a corresponding recess in the first housing half and the second housing half, and wherein the movement of the crimp jaws changes the diameter of the crimp channel such that the prosthetic heart valve is radially compressed into the compressed configuration.

12. The crimping system of claim 11, wherein the guide member and / or the cam follower is part of or coupled to the crimping jaw.

13. The curling system of claim 11, wherein the actuation assembly includes a manually actuatable member connected to one end of the screw and disposed outside the first housing half and the second housing half, and the manually actuatable member is configured to rotate the screw by manual rotation by a user.

14. The crimping system of claim 11, wherein: Each cam groove has an arc shape with one end thereof being closer to the central axis than the opposite end thereof, and Each groove has a generally linear shape with one end thereof being closer to the central axis than an opposite end thereof, and each groove extends through a thickness of a respective one of the first housing half and the second housing half.

15. The crimping system of claim 11, wherein: The difference between the first diameter in the expanded configuration and the second diameter in the compressed configuration is at least 14 mm.

16. A crimping system comprising: an artificial heart valve comprising a self-expanding frame and a plurality of leaflets within the frame, the artificial heart valve being radially contractible and expandable between an expanded configuration having a first diameter and a compressed configuration having a second diameter less than the first diameter, the artificial heart valve having a first central axis; a catheter for delivering the prosthetic heart valve in the compressed configuration to an implantation site, the catheter extending in a direction generally parallel to the first central axis; as well as A curling device for the artificial heart valve, the curling device comprising: a first housing half and a second housing half, each of the first housing half and the second housing half having a generally circular receiving aperture and a plurality of grooves around a periphery of the respective receiving aperture; A cam, comprising a first annular disk and a second annular disk, the first annular disk and the second annular disk are spaced apart from each other and aligned with respect to a second central axis, the first annular disk and the second annular disk each having a plurality of arc-shaped cam grooves around the outer periphery of the central opening thereof, the first annular disk and the second annular disk each further having a lever arm protruding radially outward from the outer periphery thereof; an actuation assembly coupled to the cam and configured to rotate the cam about the second central axis, wherein the actuation assembly includes a screw and a carriage coupled to the lever arms of the first and second annular disks, the screw extending through the carriage in a region between the lever arms such that threads of the screw engage corresponding threads of the carriage; and a crimping assembly coupled to the cam and comprising a plurality of crimping jaws disposed in a circumferential direction of the central openings of the first and second annular disks, the plurality of crimping jaws being in meshing engagement, each crimping jaw comprising a pair of spaced-apart travel blocks and a radially inner crimping wedge extending therebetween, the crimping wedges of the crimping jaws collectively defining at least a portion of a crimping channel configured to accommodate the prosthetic heart valve in the expanded configuration therein and wherein the first central axis is substantially aligned with the second central axis, wherein rotation of the screw causes rotation of the cam via the carriage and the lever arms of the first and second annular disks, which in turn causes the pair of travel blocks of at least some of the crimping jaws constrained by the grooves in the first and second housing halves to move along lines tangential to a circle about the second central axis via cam followers disposed in respective cam grooves of the first and second annular disks, causing the crimping jaws to translate inwardly toward the central axis along radial lines of the central opening, wherein the movement of each crimping jaw is constrained by a guide member disposed within a corresponding recess in the first housing half and the second housing half, and wherein the movement of the crimp jaws changes the diameter of the crimp channel such that the prosthetic heart valve is radially compressed into the compressed configuration.

17. A curling system according to claim 16, wherein the actuation assembly includes a manually actuatable member, which is connected to one end of the screw and is disposed outside the first shell half and the second shell half, and the manually actuatable member is configured to rotate the screw by manual rotation by a user.

18. The crimping system of claim 16, wherein the catheter has a sheath configured for inserting the prosthetic heart valve in the compressed configuration therein.

19. The crimping system of claim 16, wherein: The difference between the first diameter in the expanded configuration and the second diameter in the compressed configuration is at least 14 mm.

Images