Device and method for folding a medical instrument in the radial direction

Abstract

A device and method for radially folding a medical device is disclosed. The device is in the form of an improved crimper capable of crimping a medical device. The crimper of the present invention has a base plate, a stopper, two side plates, two housing plates with handles, a number of jaws, two guide plates, at least one gear ring, and a number of gear pins. The jaws, when assembled, form a series of iris openings. The crimper assembly has a central opening that is accessible from the iris openings. The device to be crimped is inserted through the central opening and held within the iris opening. Crimping is accomplished by reducing the size of the iris opening (by moving the jaws synchronously relative to one another), thereby reducing the diameter of the prosthesis.

Description

Technical Field

[0001] The present invention relates to an apparatus and method for radially contracting an artificial heart having a support structure, i.e., a frame, such as a stent / stent graft, that can contract and expand radially. Specifically, the present invention relates to reducing the diameter of a transcatheter heart valve (THV) including a support structure (stent / stent graft / frame) and valve leaflets made of a radially foldable biological tissue material or synthetic material.

Background Art

[0002] Generally, prostheses intended to be placed within the blood vessel lumen in the body include a support structure or frame that can be folded radially. The support structure / frame of the prosthesis is cylindrical and may have a uniform diameter or a tapered shape, or the diameter may vary along the axial direction. Such a prosthesis is placed by introducing it into the blood vessel lumen in the body via a catheter. In this case, it is necessary to radially fold (also called "crimping") the prosthesis on the delivery catheter. Those skilled in the art know that crimping the prosthesis is necessary to reduce the entry profile and deliver it to the implantation site in the patient's vascular system. At the implantation site, the prosthesis is placed by radially deploying the frame. The frames of these devices are either self-expanding or balloon-expandable. Balloon-expandable prostheses are generally crimped on the balloon of a balloon catheter to a reduced diameter from an initial large diameter. The prosthesis is radially expanded at the implantation site by injecting fluid into the balloon to pressurize it. Generally, physiological saline is used. Those skilled in the art are well aware of the structure and function of balloon catheters.

[0003] An artificial device clamped to the balloon of a delivery balloon catheter must be firmly fixed and attached to the balloon. If the artificial device is loose on the balloon, it may change position on the balloon or become detached from the balloon during introduction into the patient's vascular system and manipulation. An artificial device that is not properly attached to the balloon may slip off or become detached, resulting in loss or embolization. Also, the clamping must be done to minimize or prevent deformation or damage to the artificial device. At the same time, the balloon must not be damaged by the clamping process. If the balloon is damaged, blood may leak into the balloon or the infusion fluid may leak out of the balloon. Such damage weakens the balloon and may cause rupture.

[0004] The clamping operation for placing an artificial device (also referred to as a prosthesis) involves arranging the artificial device in at least a partially deployed state on a contracted or partially contracted balloon of a balloon catheter and clamping the artificial device to the balloon using a clamping device called a crimper.

[0005] Conventional crimpers have a movable part called a jaw with an inclined surface. When the jaws are assembled, an opening is formed like the iris opening of a camera. This opening has a depth sufficient to accommodate at least a partially deployed artificial heart valve. The shape of the opening is approximately circular. The jaws move synchronously to reduce or increase the size / diameter of the opening. The crimper has a mechanism for such movement of the jaws.

[0006] As described above, the iris opening formed by the inclined surface of the jaw is a regular polygon with a substantially circular shape. As is apparent to those skilled in the art, increasing the number of jaws increases the number of sides of the formed polygon. Increasing the number of jaws results in a smoother circle for the shape of the formed opening than when the number of jaws is small. This is because the length of the sides of the polygon decreases as the number of jaws increases. Clinchers available on the market generally incorporate 12 jaws, which is considered sufficient and optimal.

[0007] It is desirable to control the minimum size of the iris opening. This is to avoid excessive crimping and reduce the possibility of damaging the frame structure, soft tissue, polymer components, etc. within the device.

[0008] Conventionally, replacement of a patient's defective heart valve has been performed by open-heart surgery. Open-heart surgery is high-risk, and patients who require heart valve replacement are generally over 70 years old and often have comorbidities. Many patients are not clinically suitable to undergo such surgery and cannot receive treatment. In recent years, transcatheter heart valve replacement (THV) has become popular, and since this technique does not require open-heart surgery, the risk has been significantly reduced.

[0009] The diameter during the expansion of the THV generally ranges from about 19 to 32 mm. The THV has a stent structure (frame / stent) that holds a valve structure made of biological materials (such as pericardium). The THV is usually stored in a preservation solution (generally a dilute solution of glutaraldehyde). The THV with a dry valve projection is under development but not yet commercialized. Alternatively, the valve components can be made of synthetic materials such as polyurethane (PU) and can be stored dry. Immediately before attaching the THV to a balloon catheter (delivery system), the THV stored in the preservation solution is crimped onto the balloon of the balloon catheter. The THV with a dry valve projection can be pre-crimped onto the balloon of the delivery catheter. In any case, it is necessary to crimp the stent frame / support including the valve components onto the balloon of the delivery system.

[0010] There is a need for a crimper that can uniformly move the jaws to apply a uniform pressure to a large-diameter THV (up to 32 mm) and reduce it to 6 mm or less without generating high mechanical stress on the crimper and the THV. It is desirable that the operation of the crimper is simple and the manufacturing cost is low.

Summary of the Invention

Problems to be Solved by the Invention

[0011] The present invention describes an improved crimper and crimping method for balloon-expandable artificial devices such as THV having a support frame. The present invention describes an apparatus and a crimping method related to the THV, but is also suitable for crimping other balloon-expandable devices such as vascular stents and stent grafts.

Means for Solving the Problems

[0012] The crimper of the present invention includes at least any one of the following: a base plate, a stopper, two side plates, two housing plates with handles, a plurality of jaws, two guide plates, at least one gear ring, and a plurality of gear pins. Many components (such as side plates, housing plates, guide plates, etc.) are in two parts, that is, two split bodies. Each part is the same as or the exact opposite of another part. These components are in two parts (or two split bodies) to facilitate the assembly of the crimper, as will be apparent from the detailed description. For example, when the two parts (two split bodies) of the housing plate are assembled, a "housing" with a handle is formed. Similarly, when the two parts (two split bodies) of the guide plate are combined, a "guide housing" is formed.

[0013] When the jaws are assembled synchronously, they collectively form an iris opening. The size of the iris opening can be reduced or increased by synchronously moving the jaws simultaneously relative to each other. The jaws can be moved in this way by the mechanism described below. In the assembly of the crimper, there is a central opening accessible from the iris opening. The device to be crimped is inserted through the central opening and held within the iris opening. Crimping is achieved by reducing the size of the iris opening, thereby reducing the diameter of the device.

[0014] The movement of the handle imparts a rotational motion to the entire crimper assembly. The up-and-down movement of the handle causes the housing (an assembly of two housing plates) and the gear rings attached to each housing plate to rotate. The rotational movement of the gear ring rotates the threads of the gear pins that engage with the threads of the gear ring. The bottom pin portion of the gear pin has threads that engage with the threaded holes of the jaws. The rotation of the gear pin causes the threaded pin portion of the gear pin to engage with the threads, to some extent, inside the holes of the jaws and rotate, thereby moving the jaws. The jaws are arranged within a guide housing (an assembly of two guide plates) having a linear guide in the form of a rail. The jaws have grooves that engage with the linear guide. Thus, the jaws slide radially in synchronization along the linear guide of the guide plate and move linearly. Therefore, all the movements of the jaws are based on the gear pin and the gears and threads inside the threaded holes of the jaws. As a result, the movement of the components becomes smooth and the crimping operation becomes uniform.

[0015] The upward movement of the handle increases the size of the iris opening, and the downward movement of the handle decreases the size of the iris opening. A stopper is removably attached to the base plate to limit the position of the handle when it is moved downward so that the handle does not move further downward, thereby fixing the minimum size of the iris opening and restricting further reduction, thereby achieving a predetermined crimping diameter. This predetermined diameter may be an intermediate diameter or a diameter for preventing excessive crimping of the medical device to be crimped. Excessive crimping may damage the scaffold structure of the artificial device or the soft tissue / synthetic material contained within the THV. In one embodiment, there are multiple stoppers for achieving different iris opening sizes by replacing one stopper with another based on the requirements of the crimping operation. In another embodiment, in the case of a very small crimping diameter, the stopper is not used and the handle can be moved further downward to further reduce the size of the iris opening.

[0016] The crimping method using the crimper of the present invention includes placing a medical device in at least a partially expanded state on a deflated balloon of a delivery system. Optionally, the balloon can be partially expanded to better attach the medical device to the balloon. Next, move the handle of the crimper upward to make the size of the iris opening larger than the diameter of the medical device. Insert the balloon and the medical device at least partially into the iris opening of the crimper. Then, move the handle downward to reduce the size of the iris opening. This downward movement is manually controlled to gradually reduce the size of the opening. This downward movement of the handle can also be automated using known automation techniques. The downward movement stops when the desired crimping is achieved. This crimping may be performed in multiple stages. At this stage, the handle can be moved upward to increase the diameter of the opening, and the medical device crimped to the balloon can be removed from the crimper. If the balloon was partially expanded before crimping, it needs to be gradually deflated during the crimping operation.

[0017] Thereafter, check the diameter of the crimped medical device. If further crimping is required to make the crimping diameter even smaller, repeat the crimping operation and move the handle further downward from the previous position.

[0018] The above summary and the following detailed description of the exemplary embodiments can be better understood when read in conjunction with the accompanying drawings. For the purpose of explaining the present disclosure, various exemplary embodiments are shown in the drawings. However, the present disclosure is not limited to the descriptions and drawings disclosed herein. Furthermore, those skilled in the art will understand that the drawings are not to scale. As much as possible, the same reference numerals are used for like components.

Brief Description of the Drawings

[0019]

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Figure 10d

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Figure 10i

Mode for Carrying Out the Invention

[0020] Before describing the present invention, some words and terms are defined as follows. "Comprising" and "including" and their derivatives mean unlimited inclusion. The term "or" is inclusive, that is, it means and / or. "Connected" and "associated" and their derivatives may mean having characteristics such as including, being included, interconnecting, including, being included, connecting, or being connected, linking, being communicable, cooperating, being alternately inserted, arranging, being proximate, being joined, or being associated. The definitions of specific words and terms are given throughout this application, and those having ordinary knowledge in the relevant technical field should understand that these definitions apply not only to the past use of these words and terms but also to future use.

[0021] References throughout this application to "one embodiment", "an embodiment", or similar language mean that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases "in one embodiment", "in an embodiment", and similar language throughout this specification are not necessarily all referring to the same embodiment, and unless expressly specified otherwise, may mean "one or more, but not all embodiments". The terms "comprising", "including", "having", and variations thereof mean "including, but not limited to" unless expressly specified otherwise. The listing of items does not, unless expressly specified otherwise, mean that any or all of the items are mutually exclusive and / or mutually inclusive. The use of the singular form of a term may, unless expressly specified otherwise, also refer to the plural.

[0022] The operations of an exemplary embodiment of the disclosed method may be described in a particular sequential order for convenience of explanation, but it should be understood that the embodiments of the disclosure can include an order of operations other than the particular sequential order disclosed. For example, the operations described sequentially may, in some cases, be rearranged or performed concurrently. Further, the descriptions and disclosures provided in connection with a particular embodiment are not limited to that embodiment and are applicable to any embodiment disclosed in this application. Further, for simplicity, the accompanying drawings may not show various ways in which the disclosed systems, methods, and apparatuses can be used in combination with other systems, methods, and apparatuses.

[0023] Furthermore, the described features, advantages, and characteristics of these embodiments can be combined in any suitable way. Those skilled in the relevant art will recognize that embodiments can be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in all embodiments that are not present in a particular embodiment. The features and advantages of these embodiments will become more fully apparent from the following description and the appended claims, or can be learned by the embodiments described below.

[0024] The present invention discloses an apparatus and method for radially folding a medical device / artificial device having a support structure or frame that is radially foldable and expandable, such as a balloon-expandable or self-expandable stent / support frame. The medical device / artificial device can include an artificial heart valve such as a transcatheter heart valve (THV) having a support structure (stent / support frame) and valve leaflets made of biological tissue material or synthetic material. These valve leaflets are adapted to be folded radially and are housed within the support structure. Further, the THV may include one or more other components such as an inner skirt, an outer skirt, etc. These devices are generally balloon-expandable.

[0025] Although the present invention describes an apparatus and method for radially folding a THV, it is also suitable for crimping other balloon-expandable devices such as vascular stents, stent grafts, etc. The apparatus of the present invention is also suitable for crimping large-diameter balloon-expandable stents or artificial heart valves (THVs) that expand to 32 mm or more.

[0026] It should be noted that in the figures and the following description, the term "artificial device" as used in the specification refers to balloon-expandable artificial devices such as vascular stents, grafts, or artificial heart valves (THVs), venous valves, and other similar valves. The term "artificial valve" is also used for THVs, venous valves, or other similar valves.

[0027] The artificial heart valve has a balloon-expandable frame, to which a valve structure is attached by known methods. As is known in the art, the valve structure may be made from tissues such as, for example, bovine pericardium, porcine pericardium, equine pericardium, etc. Alternatively, the valve structure may be made from polyurethane (PU) or other known synthetic materials. The valve structure is attached to the frame by known methods such as, for example, suturing. The artificial heart valve may include other components such as an inner skirt, an outer skirt, a cross-linked support fabric, etc. The inner skirt and the outer skirt may be made from a tissue or fabric such as polyethylene terephthalate (PET).

[0028] Similarly, the terms "delivery system", "delivery catheter", or "catheter" refer to a delivery device used to place an artificial device within a blood vessel. These terms are used interchangeably and have the same meaning.

[0029] Furthermore, the device of the present invention can be used to crimp a self-expanding stent or an artificial valve that can be loaded in a crimped state (crimping state) to a restraining sheath instead of a balloon.

[0030] A device used to reduce the diameter of such a medical device is referred to in the following specification as a "crimping device", "crimping tool", or "crimping instrument". The process of reducing the diameter of a medical instrument is referred to in the following specification as "crimping". In the case of a balloon-expandable prosthesis device, so-called crimping involves attaching the medical / prosthesis device to a deflated balloon of a delivery catheter by radially compressing the device on the balloon.

[0031] The crimper disclosed in the present invention can crimp a radially expandable medical / artificial device in a single-stage or multi-stage crimping operation.

[0032] Refer to the following drawings. FIG. 1 shows the components visible from the outside of the crimper 100 of the present invention. As described above, the crimper 100 of the present invention can crimp an expandable medical device (or an expandable artificial device) to reduce the diameter of the expandable medical device from at least a partially expanded state to at least a partially crimped state.

[0033] As shown in FIG. 1, the components visible from the outside of the crimper 100 are as follows. FIG. 1 includes a base plate 101, one or more stoppers 103 (optional), two side plates 105 and 105' (only one side plate 105 is visible because 105' is on the opposite side of the assembly), a housing 107A formed by assembling two housing plates 107 and 107', a handle 109, and a plurality of jaws 111 that form an iris opening 111a (also referred to as "opening 111a" or "central opening 111a"). The crimper 100 also includes internal components disposed internally within the components visible from the outside, not limited to a guide plate, a gearing, a gear pin, etc. (described in detail below).

[0034] The components of the clipper 100 may be made of a biocompatible polymer material or a reinforced polymer material, and the reinforcement may be achieved by incorporating a fibrous material such as glass fiber into the polymer material. Examples of the polymer material include acrylonitrile-butadiene-styrene (ABS), polyoxymethylene (POM), nylon, polyester, polyamide polyether ether ketone (PEEK), etc. Alternatively, the components of the clipper 100 may be made of a biocompatible metal or metal alloy such as stainless steel or titanium. The components should have appropriate mechanical strength. Examples of the polymer material include acrylonitrile-butadiene-styrene (ABS), polyoxymethylene (POM), nylon, polyester, polyamide polyether ether ketone (PEEK), etc. Alternatively, the components of the clipper 100 may be made of a biocompatible metal or metal alloy such as stainless steel or titanium. The components should have appropriate mechanical strength. Or, the components of the clipper 100 may be made of a combination of a polymer-based material and a metal material. In a preferred embodiment of the clipper 100, the components are made of polymer materials such as ABS, polyamide, POM, and reinforced polymer materials.

[0035] The assembled clipper 100 is placed on the base plate 101. Details of the base plate 101 are shown in FIG. 2. The base plate 101 may have a predefined shape such as circular, square, rectangular, elliptical, etc. In the embodiment of FIG. 2, the predefined shape is rectangular. The shape of the base plate 101 is selected to have a sufficient surface area to firmly attach the assembled clipper 100 with sufficient supporting force and stability.

[0036] The exemplary base plate 101 of FIG. 2 includes a plurality of holes and cavities 101a to facilitate the attachment of the assembled clipper 100. The holes and cavities 101a shown in FIG. 2 are exemplary. The structure and dimensions of the holes and cavities 101a may correspond to the components of the assembly clipper 100 that engage with the base plate 101.

[0037] One or more of the optional stoppers 103 may be adjustable and removable. Thus, the stopper 103 can be detachably (removably) attached to the base plate 101. The function of the stopper 103 is to define the lower limit position of the handle 109 and limit the downward movement of the handle 109, preventing the size of the iris opening 111a from becoming even smaller. The length of the stopper 103 may depend on the specific requirements of the clamped diameter of the medical device being clamped. For example, the smaller the length of the stopper 103, the smaller the clamped diameter of the medical device. To achieve a specific clamped diameter, there may be multiple stoppers 103 of different lengths that can be attached to the base plate 101. This arrangement facilitates multi-stage clamping. FIG. 3 shows a stopper 103 which is an embodiment of the present invention.

[0038] The crimper 100 of the present invention includes several components consisting of two parts (two halves). These parts are identical or mirror images of each other. For convenience, only one of these components is shown in the figure.

[0039] The present invention may further include at least two side plates. The embodiment of the crimper 100 described herein includes two side plates, namely, a first side plate 105 and a second side plate 105' (the first side plate 105 shown in FIG. 4). The function of the first and second side plates 105 and 105' is to support the housing 107A of the crimper 100 (described below) together with other components housed within the housing 107A. The side plates 105 and 105' may be structurally similar or different. In one embodiment, the crimper 100 includes two side plates 105 and 105' attached above the base plate 101, and the housing 107A is housed therebetween. In one embodiment, the first side plate 105 is a mirror image of the second side plate 105'.

[0040] Since the second side plate 105' is a mirror image of the first side plate 105, it is not shown. The exemplary first side plate 105 is a triangular plate and has necessary reinforcing ribs for increasing a predetermined depth and mechanical strength. In FIG. 4, each side plate 105 / 105' has a central opening 105a for holding an assembled housing 107A with internal components (described below).

[0041] FIG. 1 shows the central opening 105a of the side plate 105, which is arranged concentrically with the central circular opening of the housing 107A during assembly. The assembled housing 107A is held between the first side plate 105 and the second side plate 105', and the housing 107A can rotate freely around the central opening 105a of the side plates 105, 105'. Since the first side plate 105 and the second side plate 105' are attached to the base plate 101, the assembled housing 107A is properly supported between the two side plates 105, 105'. Those skilled in the art will understand that there are various ways to configure the side plates 105 / 105' to support the assembled housing 107A between them.

[0042] The exemplary structure of the side plates 105 / 105' helps to hold and support the housing 107A of the crimper 100. However, it should be noted that the side plates 105 / 105' may include other shapes or structures, and such structures are also included within the scope of the present invention.

[0043] In one embodiment, the crimper 100 includes two housing plates 107 and 107', namely, a right housing plate and a left housing plate. The housing plates 107, 107' are held between two side plates 105 / 105' attached on the base plate 101, and the housing plates 107, 107' can rotate freely with respect to the base plate 101. Both housing plates 107 / 107' of the present invention are mirror images of each other. During assembly, the two housing plates 107, 107' form the housing 107A.

[0044] The structure of one exemplary embodiment of the housing plate 107 of the present invention is shown in FIG. 5. Since the other housing plate 107' is a mirror image of the housing plate 107, it is not shown. Both housing plates 107 / 107' are, for example, circular and have an inner diameter and a rising edge e1. The rising edge e1 may be, for example, circular. The rising edge e1 gives the housing plate 107 / 107' a shape like a tray (for example, a circular tray portion) having an extended handle portion 107b integrally formed on the rising edge e1. The extended handle portions 107b of the housing plates 107 and 107' during assembly form the handle 109 of the housing 107A.

[0045] Both housing plates 107 / 107' may include a central housing opening 107c (or opening 107c). As shown in the figure, there is a central housing opening 107c. In FIG. 5, it preferably has a circular (or round) shape.

[0046] The housing 107A formed by assembling the two housing plates 107 and 107' in each tray portion forms the housing and is used to accommodate the internal components of the crimper 100 (described below). The internal components of the crimper 100 are accommodated in the space of the housing 107A formed by joining / assembling the two housing plates 107 / 107' (described in detail below).

[0047] As shown in FIG. 1, the crimper 100 may include a plurality of jaws 111. In a preferred embodiment of the present invention, the crimper 100 includes 12 jaws 111. However, the number of jaws 111 may be less than 12 or more than 12. The jaws 111 move radially in synchronization so as to form an opening 111a (or iris opening) as a whole, as shown in FIG. 1. The opening 111a is an iris opening in the shape of a regular polygon that forms a substantially circular shape and defines a size / diameter. The size / diameter of the opening 111a can be changed in a controlled manner by the movement of the jaws 111 synchronized with the movement of the handle 109.

[0048] As described above, the iris opening 111a is formed of a regular polygon. The number of sides of the polygon is the same as the number of jaws 111. The greater the number of jaws 111, the more sides the regular polygon forming the iris opening 111a has, resulting in a smoother, more circular-like opening. In one embodiment, the iris opening 111a is formed by 12 jaws 111.

[0049] Note that the structure of all the jaws 111 is the same. However, other alternatives with jaws 111 having different structures are also within the scope of the present invention. FIG. 6 shows a jaw 111 which is a single example. As shown in FIG. 6, the jaw 111 may include a set of grooves 111b and 111b' on each of the two side surfaces, one each. The linear guides 113a of the guide plates 113 / 113' (described below) fit into the grooves 111b / 111b'. In one embodiment, the width of each groove 111b / 111b' is made to match the width of the linear guide 113a of the guide plate 113 / 113', so that the linear guide 113a fits into the groove 111b / 111b' and the jaw 111 can slide smoothly on the linear guide 113a.

[0050] The jaw part 111 may further have an upper surface 111e with a hole 111c having an internal thread. In the case shown in FIG. 6, the upper surface 111e is a flat surface. The above-mentioned screw can mesh with the screw of the pin part of the gear pin 117 (described below). Each jaw part 111 has a tapered surface 111d at the end opposite to the upper surface 111e. The tapered surfaces 111d of all the jaw parts 111 form an iris opening 111a when all the jaw parts 111 are incorporated into the guide plates 113 / 113' as described below.

[0051] The housing plates 107 and 107' of the present invention are each equipped to hold one guide plate 113 and 113', respectively. In an embodiment, the crimper 100 includes two guide plates 113 and 113' called a "right guide plate" and a "left guide plate". In an embodiment, both guide plates 113 / 113' are mirror images of each other, that is, the guide plate 113' is a mirror image of the guide plate 113. The guide plates 113, 113' form a housing when attached to each other. The jaw part 111 and the gear pin 117 are housed in a housing formed by assembling the guide plates 113, 113'.

[0052] FIG. 7 shows a single guide plate 113 of the recommended embodiment. Since the other guide plate 113' is a mirror image of the guide plate 113, it is not shown. As shown in FIG. 7, the guide plate 113 has an outer periphery with a predetermined shape such as the polygonal shape shown in FIG. 7. In an embodiment, the number of sides of the polygon is the same as the number of jaw parts 111. Each guide plate 113 / 113' may have a raised guide edge 113d with a shape as shown in FIG. 7, forming a tray-like shape.

[0053] The outer circumference of the raised guide edge 113d may be a polygonal shape having an outer dimension smaller than the inner diameter of the gear ring 115. The number of sides of the polygon is the same as the number of jaws 111 and gear pins 117. Also, the outer circumference of the raised guide edge 113d may be circular with an outer dimension smaller than the inner diameter of the gear ring 115.

[0054] The outer circumference of the guide plates 113 / 113’ has an outer dimension smaller than the inner diameter of the gear ring 115 (as described below). Thereby, the guide plates 113 / 113’ can be accommodated within the gear ring 115. Each guide plate 113 / 113’ is concentrically fitted within the corresponding housing plate 107 / 107’ inside the inner circumference of the gear ring 115. Thereby, the housing plate can rotate freely with respect to the corresponding guide plate 113 / 113’.

[0055] The guide plates 113 / 113’ may have a plurality of linear guides 113a. Each linear guide 113a may be the same as or different from each other. In one embodiment, all of the linear guides 113a are identical. As shown in FIG. 7, the linear guides 113a extend circumferentially from the central portion of the guide plate 113. The other guide plate 113’ also has similar linear guides 113a’ corresponding to the mirror image of the linear guides 113a of the guide plate 113. The linear guides 113a / 113a’ of the guide plates 113 / 113’ may be rail-shaped to guide the movement of the jaws 111. In one embodiment, the number of linear guides 113a / 113a’ is equal to the number of jaws 111. In one embodiment, the number of linear guides 113 / 113’ and the number of jaws 111 are 12.

[0056] Each linear guide 113a / 113a’ has a predetermined width and a predetermined length. Each linear guide 113a fits into one groove 111b of the jaw 111. As described above, each jaw 111 has two grooves 111b and 111b’ on both side surfaces, respectively. The other groove 111b’ of the other jaw 111 meshes with the corresponding linear guide 113a’ of the other guide plate 113’. With this arrangement, the jaw 111 can move by sliding radially on these linear guides 113a / 113a’. Therefore, the radial movement direction of the jaw 111 is controlled by the linear guides 113a / 113a’.

[0057] The guide plates 113 / 113’ can include a guide opening 113b (or a central guide opening 113b) at its center and a number of partial openings 113c in the raised guide edge 113d. In one embodiment, the number of partial openings 113c is equal to the number of jaws 111. In one embodiment, the guide opening 113b is circular. Similarly, the partial openings may be approximately semi-circular.

[0058] As shown in FIG. 7, an exemplary guide plate 113 has twelve linear guides 113a for guiding the movement of the corresponding twelve jaws 111. There are also twelve partial openings 113c. The other guide plate 113’ has the same number of linear guides 113a’ and partial openings 113c. Those skilled in the art will understand that the number of jaws 111 and linear guides 113a / 113a’ may be less than or more than twelve.

[0059] At least one of the housing plates 107 / 107’ is provided with a gear ring 115 concentrically mounted within the housing plate 107 / 107’. In one embodiment, the crimper 100 includes a single gear ring 115. In an alternative embodiment, the crimper 100 includes two gear rings 115, such as a “right gear ring” and a “left gear ring”. As shown in FIG. 8, the gear ring 115 is circular (round) and has a thread 115a on its side surface. If there are two gear rings, both gear rings 115 may be the same. Since the structures are similar, both gear rings are referred to interchangeably by the reference numeral “115”. Each gear ring 115 includes an inner diameter (inner diameter) that defines the inner circumference of the gear ring 115 and an outer diameter (outer diameter) that defines the outer circumference of the gear ring 115. In certain embodiments, the outer diameter of the gear ring 115 is smaller than the inner diameter of the circular raised edge e1 of the housing plate 107 / 107’. Thereby, each gear ring 115 can be mounted within the circular raised edge e1 of the corresponding housing plate 107 / 107’ (right or left). The inner diameter of the gear ring 115 is larger than the outer shape of the guide plate 113. Thereby, the guide plate 113 can be disposed within the inner circumference of the gear ring 115. The thread 115a of the gear ring 115 meshes with the thread of the head portion 117a of the gear pin 117 described below.

[0060] The crimper has a plurality of gear pins. Each gear pin 117 may be the same or different. In certain embodiments, all of the gear pins 117 are identical. The number of gear pins 117 may be equal to the number of jaws 111. In a preferred embodiment of the present invention, since there are 12 jaws 111 and 12 linear guides 113a / 113a’, the crimper 100 has 12 gear pins 117. However, depending on the number of jaws and linear guides, the number of gear pins may be more or less than 12.

[0061] Figure 9 shows an exemplary embodiment of the gear pin 117. Each gear pin 117 has an upper round head (or head portion) 117a and a lower pin (or pin portion) 117b. The diameter of the head portion 117a is larger than the diameter of the pin portion 117b. The upper round head 117a has an outer thread that meshes with the thread 115a present on the gear ring 115. The lower pin portion 117b also has a thread 117c that meshes with the thread of the hole 111c (described above) of the jaw portion 111.

[0062] All of the above external / internal components are assembled to form the crimper 100 of the present invention.

[0063] The method of assembling the crimper 100 described above is shown in Figure 10.

[0064] The method 10 starts with step 100a in which one of at least one gear ring 115 is concentrically attached to one of the housing plates 107. If there are other gear rings 115, the remaining gear rings 115 may be attached to another housing plate 107'. An embodiment of the assembly of the right housing plate 107 and the gear ring 115 is shown in Figure 10a, which shows the state where the housing plate 107 is placed on the base plate 101. However, the assembly does not necessarily have to be carried out on the base plate 101.

[0065] In one embodiment, when there are two gear rings 115, one gear ring 115 is mounted in a state where it can rotate freely with respect to the attached housing plate 107, and the other gear ring 115 is firmly fixed and attached in a state where it cannot rotate freely with respect to the attached housing plate 107'. Also, both gear rings 115 can be firmly fixed and attached to their respective housing plates 107 / 107' in a state where they cannot rotate freely with respect to the attached housing plates 107 / 107'. In another embodiment, a gear ring (e.g., 115) firmly fixed and attached to one housing plate (e.g., 107) is provided, and no gear ring 115 is provided on the other housing plate 107'. In a preferred embodiment, one gear ring 115 can rotate freely, and the other gear ring is fixedly attached and cannot rotate freely.

[0066] In step 100b, one of the guide plates 113 is concentrically arranged with the assembly of the housing plate 107 and the gear ring 115 in FIG. 10a. Since the outer shape of the guide plates 113 / 113' in FIG. 10a is smaller than the inner diameter of the gear ring 115, the guide plates 113 / 113' can be arranged within the inner circumference of the gear ring 115. The guide plate 113 is concentrically arranged within the inner circumference of the gear ring 115 mounted within the housing plate 107. At this time, the central housing opening 107c of the housing plate 107 and the central guide opening 113b of the guide plates 113 / 113' are concentric. FIG. 10b shows the assembly with the guide plate 113 thus mounted. As shown in FIG. 10b, the guide plate 113 fits within the inner circumference of the gear ring 115 mounted on the housing plate 107. In this embodiment, the guide plate 113 is mounted such that the housing plate 107 can rotate freely with respect to the guide plate 113. Note that the linear guide 113a extends radially.

[0067] In step 100c, the gear pin 117 and the jaw (joe) 111 are attached / fitted to the above assembly. To clarify this arrangement, the above assembly is shown in FIG. 10c including one gear pin 117 (without the jaw 111). That is, one assembly includes one gear pin 117 (without the jaw 111). In FIG. 10c, the head portion 117a of the gear pin 117 protrudes from the partial opening 113c of the guide plate 113, and the pin portion 117b protrudes inside the guide plate 113. As a result, the external thread of the head portion 117a of the gear pin 117 meshes with the thread 115a of the gear ring 115 by M (threaded engagement). Also, the pin portion 117b of the gear pin 117 fits into the partial opening 113c at the raised guide edge 113d of the guide plate 113, and all the gear pins 117 can rotate freely about their respective axes. The gear pin 117 shown in the figure has no support and cannot stay in this position. The assembly must be placed flat. FIG. 10c is shown to explain how the gear pin 117 is finally attached.

[0068] To attach the jaw 111 to the gear pin 117, the thread 117c of the pin portion 117b of the gear pin 117 meshes with the thread of the hole 111c of the jaw 111 (threaded connection). FIG. 10d shows the appearance of one gear pin 117 and one jaw 111. When fitting the jaw 111, note that one of the grooves 111b of the jaw 111 aligns and meshes with one of the linear guides 113a of the guide plate 113. Note that since the gear pin 117 and the jaw 111 are not supported, they cannot stay in this position as shown in the figure. The assembly must be placed flat. FIG. 10d is shown to explain how the gear pin 117 and the jaw 111 are finally attached.

[0069] All gear pins 117 and all jaws 111 are similarly assembled within the guide plate 113 as shown in FIG. 10e. Since all jaws 111 are arranged to engage the same number of threads as the gear pins 117 with which the jaws 111 mesh, all jaws 111 have the same radial distance from the center of the guide plate 113. In this way, by attaching all the jaws and gear pins, the tapered portions of all the jaws come together to form a uniform polygonal iris opening. Further, since the tapered surface 111d of one jaw 111 is in contact with the corresponding tapered surface 111d of the adjacent jaw 111, the above assembly is particularly stable when placed flat. Further, when arranged together in this way, i.e., when all jaws 111 are at the same radial distance from the center of the guide plate 113, the tapered surfaces 111d of all jaws 111 form an iris opening 111a at the center, as is apparent in FIG. 10e.

[0070] In step 100d, a second guide plate 113' is fixedly arranged and attached concentrically to the above assembly as shown in FIG. 10f. The central guide opening 113b of the second guide plate 113' is concentric with the central guide opening 113b of the first guide plate 113 and the central housing opening 107c of the first housing plate 107. The two guide plates 113 and 113' form a housing for accommodating the jaws 111 and the gear pins 117. When attaching the second guide plate 113', note that the linear guide 113a of the second guide plate 113' engages the second groove 111b' of the corresponding jaw 111.

[0071] As described above, the head portion 117a of the gear pin 117 protrudes from the assembly of the two guide plates 113 / 113' through the respective partial openings 113c of the two guide plates 113 / 113'. Each partial opening 113c of the guide plates 113, 113' forms a complete opening for the upper portions of the pin portions 117b of all the gear pins 117 to protrude from the assembly of the two guide plates 113 and 113'. In this way, all the gear pins 117 can freely rotate about their respective axes within these complete openings. In the assembly formed in this way, the housing plate 107 can freely rotate with respect to the guide plates 113 / 113'.

[0072] In step 100e, the second housing plate 107' (the other housing plate 107') is concentrically arranged and mounted on the above-mentioned assembly so as to be aligned with the first housing plate 107 as shown in FIG. 10g, so that the central housing opening 107c (both housing plates 107) and the guide opening 113b (both guide plates 113 / 113') are concentric. When attaching the second housing plate 107', care is taken so that the thread of the other gear ring 115 (if provided) in the second housing plate 107' engages with the thread of the head portion 117a of the gear pin 117, and the second housing plate 107' can freely rotate with respect to the assembly of the guide plates 113 and 113'. After attachment, the housing plates 107 and 107' are firmly fixed to each other to form the housing 107A so that the handle portions 107b of the two housing plates 107 and 107' form a complete handle 109 and the housing 107A can freely rotate with respect to the assembly of the two guide plates 113 and 113'.

[0073] In step 100f, as shown in FIG. 10h, side plates 105 and 105' are attached to the above assembly. The side plates 105 and 105' are arranged on both sides of an assembly consisting of a housing 107A and a combination of guide plates 107 / 107' with all internal components. The central opening 105a of the side plates 105 / 105' is concentric with the central housing opening 107c of the housing plates 107 / 107' and the guide opening 113b of the guide plates 113 / 113'. This arrangement forms the central round opening Y shown in the figure. In one aspect of FIG. 10h, the side plates 105 / 105' are firmly attached so that the housing 107A can freely rotate about the central round opening Y with respect to the side plates 105 / 105' and the guide plates 113 / 113'. The assembly of the side plates 105 / 105', the housing plates 107 / 107', and the guide plates 113 / 113' is attached to the base plate 101, and the assembly of the side plates 105 / 105' and the guide plates 113 / 113' is attached, but the housing 107A can freely rotate about the central round opening Y by moving the handle up or down.

[0074] Accordingly, the central housing opening 107c of the housing plates 107 / 107' and the guide opening 113b of the guide plates 113 / 113' coincide to receive a radially expandable and foldable artificial device within the iris opening 111a.

[0075] In the above assembly, an optional removable stopper 103 is mounted as shown in FIG. 10i. FIG. 10i shows a clipper 100 with the stopper 103 set in a vertical position that restricts the movement of the handle 109 of the housing plate 107. The handle 109 cannot be moved further down, and the minimum size / diameter of the opening 111a corresponding to the lowest position of the handle 109 restricted by the stopper 103 is limited. When the handle 109 is moved upward, the size / diameter of the opening 111a increases, and this diameter is maximum at the uppermost position. When the stopper 103 is shortened, the minimum size / diameter of the opening 111a becomes smaller. In the absence of the stopper 103, the handle 109 has no restriction for further downward movement, and the size / diameter of the opening 111a becomes very small.

[0076] The clipper 100 disclosed above operates in a predetermined manner as described below. The movement of the handle 109 imparts a rotational movement to the internal components disposed within the housing formed by the housing 107A around the central circular opening Y and the two guide plates 113 and 113'. This movement causes the gear ring 115 to rotate, and as a result, the head portion 117a of the gear pin 117 rotates. Also, the pin portion 117b of the gear pin 117 rotates within the internal thread portion of the hole 111c provided on the upper surface 111e of the respective jaw portion 111, thereby sliding and linearly moving the jaw portion 111 radially in synchronization along the linear guides 113a / 113a' of the guide plates 113 / 113'. Due to this movement of the jaw portion 111, the size (shrinking or expanding) of the opening (iris opening) 111a formed by the tapered surface 111d of the jaw portion 111 changes. When the handle 109 is moved upward, the gear ring 115 also rotates in the same direction. By this operation, the gear pin 117 rotates, and the jaw portions 111 move away from each other, increasing the size / diameter of the iris opening 111a. When the handle 109 is moved downward, similarly, the jaw portions 111 approach each other, decreasing the size / diameter of the iris opening 111a.

[0077] The crimping method using the crimper 100 of the present invention includes placing the crimped medical device (in at least a partially expanded state) on the deflated balloon of the delivery system. If necessary, the balloon can be partially inflated to enable the medical device to be properly attached to the balloon. Next, the handle 109 of the crimper 100 is moved upward to make the size of the iris opening 111a larger than the diameter of the prosthesis device in at least a partially expanded state. The balloon and the prosthesis device are at least partially inserted / positioned into the iris opening 111a of the crimper 100. Thereafter, the handle 109 is gradually moved downward to reduce the size of the iris opening 111a and reduce the diameter of the prosthesis device, i.e., crimp the prosthesis device. This downward movement is manually controlled to gradually reduce the size of the iris opening 111a. Alternatively, this downward movement can also be automated. The downward movement of the handle 109 is stopped when the desired crimping is achieved. This may be done in multiple steps. The crimped diameter of the artificial device can be controlled by determining when to stop the downward movement of the handle 109 or by further restricting the downward movement with a stopper 103.

[0078] At this stage, the handle 109 is moved upward to increase the size of the iris opening 111a and remove the artificial device crimped to the balloon from the opening 111a of the crimper 100.

[0079] Next, the crimped artificial device is inspected to confirm whether the desired crimping level has been achieved. If further crimping is required to further reduce the crimping diameter, the crimping operation is repeated and the handle is moved further downward than the previous position.

[0080] The scope of the present invention is limited only by the appended claims. More generally, those skilled in the art will readily understand that all parameters, dimensions, materials, and configurations described herein are exemplary only, and that actual parameters, dimensions, materials, and / or configurations will vary depending on the particular application or use for which the teachings of the present invention are employed.

Claims

1. A crimping device for crimping a radially expandable and foldable prosthetic device to reduce it from a state where the diameter is at least partially expanded to a crimped state, comprising: a base plate, two housing plates attached to the base plate so as to be freely rotatable with respect to the base plate, each housing plate having a circular tray portion with a central housing opening and a handle portion extending from the tray portion, and when the two housing plates are assembled, the tray portions of the housing plates form a housing for accommodating other components of the crimping device, the handle portions of the housing plates form handles, and at least one of the two housing plates is provided with a circular gear ring concentrically attached inside the housing plate, the gear ring having a thread, the gear ring having an inner diameter defining an inner circumference and an outer diameter defining an outer circumference, two housing plates; two guide plates attached to each other to form a housing, each guide plate being concentrically received inside the housing plate inside the inner circumference of the gear ring so that each housing plate can rotate freely with respect to each guide plate, each guide plate having a central guide opening and a plurality of identical linear guides extending radially outward from the central portion of the guide plate, each linear guide having a width and a length, two guide plates; a plurality of identical jaws, each jaw having an upper surface, a tapered surface and two side surfaces, each jaw further comprising: (a) a hole in the upper surface, the hole having an internal thread; (b) two grooves, each in one of the two side surfaces of each jaw, the width of the grooves corresponding to the width of the linear guides of the guide plate so that the linear guides fit into the grooves and the jaws can slide on the linear guides; (c) a tapered surface, and when all the jaws are assembled, the tapered surfaces of the jaws form an iris opening as a whole, and the size of the iris opening changes when the handle is moved and the jaws are synchronously controlled to move, a plurality of identical jaws. A plurality of identical gear pins, each gear pin having a head portion and a threaded pin portion, the head portion having an outer thread that meshes with the thread of the gear ring, and the thread of the pin portion meshing with the inner thread of the hole in the upper surface of the jaw portion, and a plurality of identical gear pins. The central housing opening of the housing plate and the central guide opening of the guide plate are aligned with each other so as to receive the prosthesis within the iris opening formed by the jaw portion for crimping the prosthesis. When the handle is moved, the housing plate rotates around the central circular opening, the gear ring rotates, and further, as the head portion of the gear pin rotates, the thread of the pin portion of the gear pin rotates within the inner thread of the hole in the upper surface of the jaw portion, and the jaw portion moves radially along the linear guide of the guide plate, and the size of the iris opening changes, a crimping device.

2. The crimping device according to claim 1, wherein the housing plate is held between two side plates and is attached to the base plate, so that the housing plate rotates freely with respect to the side plates.

3. The crimping device according to claim 1, wherein each housing plate has an inner diameter and a rising edge.

4. The crimping device according to claim 1, wherein the gear ring has an outer diameter smaller than the inner diameter of the rising edge of the housing plate.

5. The crimping device according to claim 1, wherein the diameter of each head portion of the gear pin is larger than the diameter of the pin portion of the gear pin.

6. The crimping device according to claim 1, wherein the guide plate has a raised guide edge, and the guide edge has an outer circumference in a circular shape having an outer diameter smaller than the inner diameter of the gear ring.

7. The crimping device according to claim 1, wherein the guide plate has a raised guide edge, and the guide edge has an outer circumference in a polygonal shape having an outer diameter smaller than the inner diameter of the gear ring.

8. The crimping device according to claim 7, wherein the number of sides of the polygon is the same as the number of jaws.

9. The crimping device according to claim 1, wherein the number of gear pins and the number of linear guides of each guide plate are each the same as the number of jaws.

10. The crimping device according to any one of claims 1 to 9, wherein the number of linear guides of each guide plate, the number of the gear pins, and the number of the jaws are each 12.

11. The crimping device according to claim 1, wherein the number of linear guides in each guide plate, the number of the gear pins, and the number of the jaws are each more than 12 or less than 12.

12. The crimping device according to any one of claims 1 to 11, wherein the gear ring is fixedly attached to one of the two housing plates, and the other housing plate does not have a gear ring.

13. The crimping device according to any one of claims 1 to 11, wherein each gear ring is attached to each housing plate, one gear ring rotates freely, and the other gear ring is fixed to the housing plate.

14. The crimping device according to claim 1, wherein each gear ring is fixedly attached to each housing plate.

15. The crimping device according to any one of claims 1 to 11, wherein the gear ring is attached to one of the two housing plates so as to rotate freely with respect to the one housing plate, and the other housing plate does not have a gear ring.

16. The crimping device according to any one of claims 1 to 15, wherein the crimping device is made of a polymer material, a metal material, or a combination of these materials.

17. The crimping device according to any one of claims 1 to 16, wherein the base plate includes one or more stoppers, the stoppers are fixedly attached or removably attached to the base plate, limit the downward movement of the handle to define the lowest position of the handle, and prevent the size of the iris opening from becoming smaller.

18. The crimping device according to any one of claims 1 to 17, wherein the prosthesis is either a balloon-expandable prosthesis or a self-expandable prosthesis.

19. The crimping device according to any one of claims 1 to 18, wherein the prosthesis is either a vascular stent or a transcatheter heart valve.

20. A method of assembling a crimping device, The step of attaching a gearing to at least one of the plurality of housing plates; The step of concentrically arranging the first guide plate inside the inner circumference of the gearing so that the housing plate can rotate freely with respect to the first guide plate among the two guide plates attached to each other to form a housing; The step of attaching a plurality of gear pins to each of the two guide plates, wherein the head portion of each gear pin is screwed into engagement with the gearing, and after the engagement, each gear pin can rotate freely on each axis; The step of aligning each of the grooves of the plurality of jaws with each linear guide of the first guide plate and at the same time attaching each jaw to each pin portion of the gear pin by screw connection, meshing the thread of the pin portion with the thread of the hole on the upper surface of the jaw, and making all the jaws at the same radial distance from the center of the first guide plate by forming a regular polygonal iris opening with the plurality of jaws; The step of forming a housing in which the gear pin and the jaw are attached by concentrically arranging and fixedly attaching the second guide plate to the first guide plate; The step of concentrically arranging the other housing plate on the second guide plate so that the other housing plate can rotate freely with respect to the assembly of the first guide plate; The step of fixedly attaching the two housing plates to each other to form a housing including a handle formed by the handle portions of the two housing plates after attachment. A method comprising:

21. The method according to claim 20, wherein the step of attaching the gearing includes the step of attaching one gearing to one housing plate so that the gearing can rotate freely or be fixedly attached.

22. The method according to claim 20, wherein the step of attaching the plurality of gear pins includes the step of meshing each head portion of the gear pins protruding from the first guide plate with the thread of the gearing attached in the housing plate.

23. The method according to claim 20, wherein the step of attaching the plurality of gear pins includes the step of screwing the pin portion of each gear pin into the internal thread of a hole provided on the upper surface of the jaw portion.

24. The method according to claim 20, wherein aligning each of the plurality of grooves of the jaw portions with each linear guide of the first guide plate includes engaging each groove on the side surface of each jaw portion with each linear guide of the guide plate.

25. The method according to claim 20, wherein forming the plurality of jaw portions to form the regular polygonal iris opening includes attaching the tapered surfaces of all the jaw portions to the guide plate to form the regular polygonal iris opening.

26. The method according to claim 20, wherein the step of disposing the second guide plate includes engaging the plurality of second grooves of the jaw portions with the linear guides of the second guide plate, leaving the head portions of the gear pins protruding from the assembly of the second guide plate, and allowing the gear pins to rotate freely along each axis.

27. The method according to claim 20, wherein concentrically disposing the other housing plate on the second guide plate includes engaging the thread of the head portion of the gear pin with the thread of a gear ring disposed within the other housing plate.

28. The method according to claim 20, including steps of attaching one or more side plates to each side of the housing plate, the openings of the side plates being concentric with the central housing opening of the housing plate, the guide openings of the guide plate forming a central circular opening, and the housing plate being freely rotatable about the central round opening with respect to the side plates and the guide plate.

29. The method according to claim 20, including steps of attaching the assembly of the side plate, the housing plate, and the guide plate to a base plate, stationary the assembly of the side plate and the guide plate, and allowing the assembly of the housing plate to rotate freely about the central round opening by moving the handle upward or downward.

30. The method according to claim 20, wherein the step of attaching the gear ring includes the step of fixedly attaching the gear ring to one of the housing plates.

31. The method according to claim 20, wherein the step of attaching the gear ring includes attaching the gear ring to one of the housing plates so that one gear ring rotates freely.

32. The method according to claim 20, wherein the step of attaching the gear ring includes fixedly attaching one gear ring to each housing plate so that the other gear ring rotates freely.

33. A method of assembling a crimping device, comprising: attaching one gear ring to at least one of a plurality of housing plates so that the gear ring rotates freely within the housing plate or is fixedly attached; concentrically arranging a first guide plate within the housing plate to which the gear ring is attached so that the housing plate can rotate freely with respect to the first guide plate; attaching a plurality of gear pins such that the head portions of the gear pins protrude from the first guide plate and the external threads of the head portions of the gear pins mesh with the threads of the gear ring attached to the housing plate, and all the gear pins rotate freely on each axis; threading the pin portions of the gear pins into the internal threads of the holes in the upper surface of the jaw portion, attaching the jaw portion to the gear pins such that each groove on the side surface of each jaw portion meshes with each linear guide of the guide plate, the jaw portion being arranged such that the threads of the pin portion mesh with the threads of the hole in the upper surface of the jaw portion, all the jaw portions being at the same radial distance from the center of the guide plate, and all the jaw portions and gear pins being attached such that the tapered surfaces of all the jaw portions form a regular polygonal iris opening; concentrically arranging a second guide plate on top of the first guide plate to form a housing to which the gear pins and the jaw portions are attached, each groove of the second guide plate meshing with each second groove of the jaw portion, the head portions of the gear pins protruding from the assembly of the two guide plates, and the gear pins rotating freely along each axis. Place the other housing plate concentrically on the second guide plate, engage the threads of the gear ring inside the other housing plate with the threads of the head portion of the gear pin, and enable the other housing plate to rotate freely with respect to the assembly of the two guide plates; Fix and attach both housing plates. After attachment, a housing is formed, the handle portions of the two housing plates form a complete handle, and the assembly of the two housing plates is enabled to rotate freely with respect to the assembly of the two guide plates; Attach side plates to each side of the assembly of the housing plate and the guide plate. The central opening of the side plate is concentric with the central housing opening of the housing plate and the guide opening of the guide plate to form a central round opening, and the assembly of the housing plate is enabled to rotate freely with respect to the side plate and the guide plate around the central round opening; Fix and attach the side plates to each other and also fix and attach the side plates to the guide plate so that the assembly of the housing plate can rotate freely with respect to the side plate and the guide plate around the central round opening; Attach the assembly of the side plate, the housing plate, and the guide plate to a base plate, keep the assembly of the side plate and the guide plate stationary, and enable the assembly of the housing plate to rotate freely around the central round opening, including the steps of; When the handle is moved, the housing plate rotates around the central round opening, the gear ring rotates, and further the head portion of the gear pin rotates, so that the threads of the pin portion of the gear pin rotate inside the internal threads of the hole on the upper surface of the jaw portion, the jaw portion moves radially along the linear guide of the guide plate, and the size of the iris opening changes.

34. A method of crimping a radially foldable and expandable prosthesis using the crimping device according to any one of claims 1 to 19, Moving the handle upward to increase the size of the iris opening formed by the jaws such that the size of the iris opening is larger than the diameter of the prosthetic device to be crimped; Placing the prosthetic device at least partially expanded within the iris opening; Moving the handle gradually downward to decrease the size of the iris opening and crimping the prosthetic device in one or more steps; Controlling the diameter of the prosthetic device to be crimped by judging to stop the downward movement of the handle or further restricting the downward movement of the handle by a stopper of the crimping device according to claim 17; Moving the handle upward to increase the size of the iris opening; Removing the crimped prosthetic device from the iris opening, the method comprising.

35. The method according to claim 34, wherein the prosthetic device is of a balloon-expandable type.

36. The method according to claim 34, wherein the step of placing the prosthetic device at least partially expanded within the iris opening includes placing the crimped prosthetic device on a contracted balloon within the iris opening.

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