Device and method for radially folding medical device

Abstract

To disclose a device and method for radially folding a medical device.SOLUTION: A device is in a form of an improved crimper capable of crimping medical devices. The crimper includes 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. When being assembled, the jaws form a series of iris openings. The crimper assembly has a central opening that is accessible through the iris opening. A crimping object device is inserted from the central opening and held within the iris opening. Crimping is achieved by reducing the size of the iris openings (by synchronously moving the jaws relative to one another), thereby reducing a diameter of a prosthesis.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to an apparatus and method for radially contracting a cardiac prosthesis having a radially contractible and expandable support structure or frame, such as a stent / scaffold. Specifically, the present invention relates to reducing the diameter of a transcatheter cardiac prosthesis (THV) that includes a support structure (stent / scaffold / frame) and radially collapsible valve leaflets made of biological or synthetic materials. [Background technology]

[0002] Generally, prostheses intended for placement within a vascular lumen in the body include a radially collapsible support structure or frame. The prosthesis support structure / frame is cylindrical and may have a uniform diameter, a tapered shape, or a varying diameter along its axial direction. Such prostheses are deployed by introduction into the vascular lumen in the body via a catheter. This requires radially collapsing (also known as "crimping") the prosthesis onto the delivery catheter. Those skilled in the art will appreciate that crimping the prosthesis reduces its entry profile and facilitates its introduction into the patient's vasculature. It is known that delivery to the deployment site is necessary, where the prosthesis is deployed by radially expanding the frame. The frames of these devices can be either self-expanding or balloon-expandable. Balloon-expandable prostheses are typically crimped onto the balloon of a balloon catheter from an initial large diameter to a reduced diameter. At the deployment site, the prosthesis is radially expanded by injecting a fluid into the balloon to pressurize it, typically saline. Those skilled in the art are familiar with the structure and function of balloon catheters.

[0003] The prosthesis crimped onto the balloon of the delivery balloon catheter must be securely attached to the balloon. If the prosthesis is loose on the balloon, it may change position on the balloon or become dislodged from the balloon during introduction and manipulation into the patient's vasculature. A prosthesis that is not properly attached to the balloon may slip off or become dislodged, resulting in loss or embolization. Additionally, crimping must be performed in a way that minimizes or prevents deformation or damage to the prosthesis. At the same time, the crimping process must not damage the balloon. Damage to the balloon can allow blood to leak into the balloon or injectate to leak out of the balloon, weakening the balloon and potentially causing it to burst.

[0004] The crimping procedure for placing a prosthesis involves placing the prosthesis in an at least partially deployed state over a deflated or partially deflated balloon of a balloon catheter and crimping the prosthesis onto the balloon using a crimping device called a crimper.

[0005] A conventional crimper has moving parts called jaws with angled faces. When the jaws are assembled, they create an opening similar to the iris opening of a camera. This opening is deep enough to accommodate at least a partially deployed prosthetic heart valve. The opening is approximately circular in shape. The jaws move synchronously to reduce or increase the size / diameter of the opening. The crimper has a mechanism for this movement of the jaws.

[0006] As described above, the iris opening formed by the angled surfaces of the jaws is a regular polygon with a generally circular shape. As will be apparent to those skilled in the art, increasing the number of jaws also increases the number of sides of the polygon formed. With a greater number of jaws, the opening formed will be more of a smooth circle than with a fewer number of jaws. This is because the sides of the polygon decrease as the number of jaws increases. Commercially available crimpers typically incorporate 12 jaws, which is considered sufficient and optimal.

[0007] It is desirable to control the minimum size of the iris opening to avoid excessive crimping and reduce the possibility of damaging the framework, soft tissue, or polymeric components within the device.

[0008] Traditionally, patients' defective heart valves have been replaced through open-heart surgery. Open-heart surgery is risky, and patients requiring heart valve replacement are generally over 70 years old and often have coexisting medical conditions. Many patients are not clinically suitable for such surgery and are unable to undergo treatment. In recent years, transcatheter prosthetic heart valve replacement (THV) has become popular; this technique does not require open-heart surgery, significantly reducing the risks.

[0009] The expanded diameter of a THV typically ranges from approximately 19 to 32 mm. THVs have a support structure (frame / stent) made of biological material (such as pericardium) that holds the valve structure. THVs are typically stored in a preservative solution (typically a dilute solution of glutaraldehyde). THVs with dry valve protrusions are under development but have not yet been commercialized. Alternatively, the valve components can be made of synthetic materials such as polyurethane (PU) and stored dry. Just before loading the THV onto a balloon catheter (delivery system), the THV, stored in a preservative solution, is crimped onto the balloon of the balloon catheter. Once dry, THVs with valve projections can be pre-crimped onto the balloon of the delivery catheter. In either case, the stent frame / scaffold containing the valve components must be crimped onto the balloon of the delivery system.

[0010] What is needed is a crimper that applies uniform pressure to large diameter THVs (up to 32 mm) to reduce them to 6 mm or less, with uniform jaw movement that does not create high mechanical stresses on the crimper or THV. It is desirable that the crimper be easy to operate and inexpensive to manufacture. Summary of the Invention [Problem to be solved by the invention]

[0011] The present invention describes an improved crimper and crimping method for balloon expandable prosthetic devices such as THVs with support frames. Although the present invention describes an apparatus and crimping method for THVs, it is also suitable for crimping other balloon expandable devices such as vascular stents, stent grafts, etc. [Means for solving the problem]

[0012] The crimper of the present invention includes at least any of the following: a base plate, a stopper, two side plates, two housing plates with handles, multiple jaws, two guide plates, at least one gear ring, and multiple gear pins. Many of the components (such as the side plate, housing plate, and guide plate) are two-part, i.e., two halves. Each part is either the same as the other or the exact opposite of the other. As will be apparent from the detailed description, these components are two-part (or two halves) to facilitate assembly of the crimper. For example, when the two halves (two halves) of the housing plate are assembled, they form a "housing" with a handle. Similarly, when the two halves (two halves) of the guide plate are combined, they form a "guide housing."

[0013] The jaws, when assembled synchronously, collectively form an iris opening. The size of the iris opening can be reduced or increased by synchronously moving the jaws together. The jaws can be moved in this manner by a mechanism described below. The crimper assembly has 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 rotational motion to the entire crimper assembly. The up-and-down movement of the handle rotates the housing (an assembly of two housing plates) and the gear rings attached to each housing plate. The rotation of the gear ring rotates the threads of the gear pin, which engages with the threads of the gear ring. The bottom pin of the gear pin has threads that engage with the threaded holes in the jaws. Rotation of the gear pin causes the threaded pin of the gear pin to rotate and engage with the threads in the holes of the jaws, causing the jaws to move. The jaws are located in a guide housing (an assembly of two guide plates) with a linear guide in the form of a rail. The jaws have grooves that engage with the linear guide. Therefore, the jaws slide radially and linearly in sync along the linear guide of the guide plates. Therefore, all jaw movement is based on the gears and threads inside the gear pins and threaded holes in the jaws. This results in smooth movement of the components and uniform crimping.

[0015] Moving the handle upward increases the size of the iris opening, while moving it downward decreases it. A stopper can be removably mounted on the base plate to limit the handle's position when moved downward, preventing further downward movement and thereby fixing a minimum iris opening size and limiting further reduction, thereby achieving a predetermined crimping diameter. This predetermined diameter can be an intermediate diameter or a diameter designed to prevent over-crimping of the medical device being crimped. Over-crimping can damage the scaffolding structure of the prosthetic device or the soft tissue / synthetic material contained within the THV. In one embodiment, there are multiple stoppers to achieve different iris opening sizes by replacing one with another based on the requirements of the crimping operation. In another embodiment, for very small crimping diameters, no stopper is used, and the handle can be moved further downward to further reduce the iris opening size.

[0016] A crimping method using the crimper of the present invention involves placing a medical device in an at least partially expanded state over a deflated balloon of a delivery system. If necessary, the balloon may be partially expanded to better fit the medical device to the balloon. The handle of the crimper is then moved upward to increase the size of the iris opening beyond the diameter of the medical device. The balloon and medical device are then at least partially inserted into the iris opening of the crimper. The handle is then moved downward to decrease the size of the iris opening. This downward movement gradually decreases the size of the opening. , is controlled manually. 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, during which the handle is moved upward to increase the diameter of the opening so that the medical device crimped onto the balloon can be removed from the crimper. If the balloon is partially expanded prior to crimping, it must be gradually deflated during the crimping operation.

[0017] The diameter of the crimped medical device is then checked. If further crimping is required to further reduce the crimp diameter, the crimping operation is repeated, moving the handle further downward than the previous position.

[0018] The foregoing summary, as well as the following detailed description of exemplary embodiments, will be better understood when read in conjunction with the accompanying figures. For the purposes of illustrating the disclosure, various exemplary embodiments are shown in the figures. However, the disclosure is not limited to the descriptions and figures disclosed herein. Furthermore, those skilled in the art will understand that the figures are not to scale. Wherever possible, like elements have been numbered identically. [Brief explanation of the drawings]

[0019] [Figure 1] 1 shows the crimper 100 in an assembled state showing the externally visible parts according to one embodiment of the present invention.

[0020] [Figure 2] 1 shows a base plate 101 of a crimper 100 according to an embodiment of the present disclosure.

[0021] [Figure 3] 1 shows a stopper 103 of a crimper 100 according to an embodiment of the present disclosure.

[0022] [Figure 4]1 shows a side plate 105 of a crimper 100 according to an embodiment of the present disclosure.

[0023] [Figure 5] 1 shows a housing plate 107 of a crimper 100 according to an embodiment of the present disclosure.

[0024] [Figure 6] 1 shows jaws 111 of a crimper 100 according to an embodiment of the present disclosure.

[0025] [Figure 7] 1 illustrates a guide plate 113 of a crimper 100 according to an embodiment of the present disclosure.

[0026] [Figure 8] 1 shows a gear ring 115 of a crimper 100 according to an embodiment of the present disclosure.

[0027] [Figure 9] 1 shows a gear pin 117 of a crimper 100 according to an embodiment of the present disclosure.

[0028] [Figure 10] 1 shows a flowchart of a method for assembling a crimper 100 according to an embodiment of the present disclosure.

[0029] [Figure 10a] 1A-1C illustrate different stages in the assembly of a crimper 100 according to an embodiment of the present disclosure. [Figure 10b] 1A-1C illustrate different stages in the assembly of a crimper 100 according to an embodiment of the present disclosure. [Figure 10c] 1A-1C illustrate different stages in the assembly of a crimper 100 according to an embodiment of the present disclosure. [Figure 10d] 1A-1C illustrate different stages in the assembly of a crimper 100 according to an embodiment of the present disclosure. [Figure 10e] 1A-1C illustrate different stages in the assembly of a crimper 100 according to an embodiment of the present disclosure. [Figure 10f] 1A-1C illustrate different stages in the assembly of a crimper 100 according to an embodiment of the present disclosure. [Figure 10g] 1A-1C illustrate different stages in the assembly of a crimper 100 according to an embodiment of the present disclosure. [Figure 10h] 1A-1C illustrate different stages in the assembly of a crimper 100 according to an embodiment of the present disclosure. [Figure 10i] 1A-1C illustrate different stages in the assembly of a crimper 100 according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0030] Before describing the present invention, certain words and terms are defined as follows: "Include" and "Comprise" and their derivatives mean an open-ended inclusion. The term "or" is inclusive, meaning and / or. "Coupled" and "Associated" and their derivatives may mean include, include, interconnect, include, contain, connect or be connected, couple, be in communication with, cooperate with, interleave, juxtapose, contiguous, linked or associated, have a characteristic, and the like. Definitions of certain words and terms are provided throughout this application and are within the skill of those in the art. Those skilled in the art will understand that these definitions apply to past as well as future uses of these words and terms.

[0031] References throughout this application to "one embodiment," "an embodiment," or similar phrases mean that a particular feature, structure, or characteristic is included in at least one embodiment. Thus, appearances of "in one embodiment," "in an embodiment," and similar phrases throughout this specification do not necessarily all refer to the same embodiment and may mean "one or more, but not all, embodiments," unless expressly specified otherwise. The terms "including," "comprising," "having," and variations thereof mean "including, but not limited to," unless expressly specified otherwise. Listing of items does not imply that any or all of the items are mutually exclusive and / or mutually inclusive, unless expressly specified otherwise. Terms in the singular may also refer to the plural unless expressly specified otherwise.

[0032] Although the operations of exemplary embodiments of the disclosed methods may be described in a particular sequential order for convenience of description, it should be understood that embodiments of the present disclosure may encompass orders of operations other than the particular sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Furthermore, the description and disclosure provided in connection with a particular embodiment is not limited to that embodiment but may be applicable to any embodiment disclosed herein. Furthermore, for simplicity, the accompanying drawings may depict the disclosed systems, methods, and apparatus in a variety of different ways, including but not limited to other systems. It may not be representative of the various methods that can be used in conjunction with the systems, methods, and apparatus.

[0033] Furthermore, the described features, advantages, and characteristics of these embodiments may be combined in any suitable manner. 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 appended claims, or may be learned by the embodiments described hereinafter.

[0034] The present invention discloses an apparatus and method for radially collapsing a medical device / prosthesis having a radially collapsible and expandable support structure or frame, such as a balloon-expandable or self-expandable stent / scaffold / support frame. The medical / prosthetic device can include a prosthetic heart valve, such as a transcatheter heart valve (THV), having a support structure (stent / scaffold / frame) and leaflets made of biological or synthetic materials. These leaflets are radially collapsible and contained within the support structure. Additionally, the THV may include one or more other components, such as an internal skirt, an external skirt, etc. These devices are typically balloon-expandable.

[0035] Although the present invention describes a radially collapsible apparatus and method for THVs, 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 balloon expandable stents or prosthetic heart valves (THVs) that expand to large diameters of 32 mm or greater.

[0036] It should be noted that in the figures and the following description, the term "prosthetic device" as used herein refers to a vascular stent, graft, or balloon-expandable prosthetic device such as a thoracic valve (THV), venous valve, or other similar valve. The term "prosthetic valve" also applies to a THV, venous valve, or other similar valve.

[0037] The prosthetic heart valve has a balloon-expandable frame to which a valve structure is attached using known methods. As known in the art, the valve structure may be made from tissue such as bovine pericardium, porcine pericardium, or equine pericardium. Alternatively, the valve structure may be made from polyurethane (PU) or other known synthetic materials. The valve structure is attached to the frame using known methods, such as suturing. The prosthetic heart valve may include other components, such as an inner skirt, an outer skirt, and a commissure support fabric. The inner and outer skirts may be made from tissue or fabric such as polyethylene terephthalate (PET).

[0038] Similarly, the terms "delivery system," "delivery catheter," or "catheter" refer to a delivery apparatus used to place a prosthetic device within a blood vessel. These terms are used interchangeably and have the same meaning.

[0039] Additionally, the device of the present invention can be used to crimp self-expanding stents and prosthetic valves that can be loaded in a crimped state onto a constraining sheath rather than onto a balloon.

[0040] Apparatus used to reduce the diameter of such medical devices will be referred to hereinafter as a "crimping apparatus," "crimper," or "crimping tool." The process of reducing the diameter of a medical device will be referred to hereinafter as "crimping." In the case of balloon-expandable prosthetic devices, so-called crimping involves radially compressing the medical / prosthetic device onto the balloon, thereby mounting it onto the deflated balloon of the delivery catheter.

[0041] The crimper disclosed in the present invention is capable of crimping radially expandable medical / prosthetic devices in a single or multi-step crimping operation.

[0042] Referring now to the drawings, Figure 1 shows the externally visible components of a crimper 100 of the present invention. As previously described, the crimper 100 of the present invention is capable of crimping an expandable medical device (or expandable prosthetic device) to reduce the diameter of the expandable medical device from an at least partially expanded state to an at least partially crimped state.

[0043] As shown in Figure 1, the externally visible components of crimper 100 include: 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 multiple jaws 111 forming an iris opening 111a (also referred to as "opening 111a" or "central opening 111a"). Crimper 100 also includes internal components disposed internally within the externally visible components, such as, but not limited to, guide plates, gear rings, gear pins, etc. (described in more detail below).

[0044] The components of the crimper 100 may be made of biocompatible polymeric materials or reinforced polymeric materials, and reinforcement may be achieved by incorporating fibrous materials, such as glass fibers, into the polymeric materials. Polymeric materials may include acrylonitrile-butadiene-styrene (ABS), polyoxymethylene (POM), nylon, polyester, polyamide polyether ether ketone (PEEK), and the like. Alternatively, the components of the crimper 100 may be made from biocompatible metals or metal alloys, such as stainless steel, titanium, and the like. The components should have adequate mechanical strength. Polymeric materials include acrylic, Examples of suitable materials include abrasives such as athracycline, thiazolinone, thiazolinone (THA), ...

[0045] The assembled crimper 100 is placed on a base plate 101, which is shown in detail in FIG. 2. The base plate 101 may have a predefined shape, such as a circle, a square, a rectangle, an oval, etc. In the embodiment of FIG. 2, the predefined shape is a rectangle. The shape of the base plate 101 is selected to have a sufficient surface area to securely mount the assembled crimper 100 with sufficient support and stability.

[0046] The exemplary base plate 101 of Figure 2 includes a plurality of holes and cavities 101a to facilitate mounting of the assembled crimper 100. The holes and cavities 101a shown in Figure 2 are exemplary. The configuration and dimensions of the holes and cavities 101a may correspond to components of the assembled crimper 100 that mate with the base plate 101.

[0047] The optional one or more stoppers 103 may be adjustable and removable. Thus, the stoppers 103 may be detachably (removably) attached to the base plate 101. The function of the stoppers 103 is to define a lower limit position of the handle 109, limiting its downward movement and preventing the iris opening 111a from becoming even smaller. The length of the stoppers 103 may depend on the specific requirements of the crimped diameter of the medical device being crimped. For example, the shorter the length of the stoppers 103, the smaller the crimped diameter of the medical device. To achieve a specific crimped diameter, there may be multiple stoppers 103 of different lengths that can be attached to the base plate 101. This arrangement facilitates multi-stage crimping. FIG. 3 illustrates a stopper 103 according to an embodiment of the present invention.

[0048] The crimper 100 of the present invention includes several components that are two-part (two halves) that are either identical or mirror images of each other. For convenience, only portions of these components are shown in the figures.

[0049] The present invention may further include at least two side plates. The embodiment of the crimper 100 described herein includes two side plates: a first side plate 105 and a second side plate 105' (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 (described below) of the crimper 100, along 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' mounted above the base plate 101, with the housing 107A housed between them. In one embodiment, the first side plate 105 is a mirror image of the second side plate 105'.

[0050] The second side plate 105' is not shown as it is a mirror image of the first side plate 105. The exemplary first side plate 105 is a triangular plate with a predetermined depth and necessary reinforcing ribs for increased mechanical strength. In FIG. 4, each side plate 105 / 105' has a central opening 105a that holds the assembled housing 107A with its internal components (described below).

[0051] FIG. 1 shows the central opening 105a of the side plate 105, which is concentric with the central circular opening of the assembled housing 107A. The assembled housing 107A is held between the first side plate 105 and the second side plate 105', allowing the housing 107A to freely rotate around the central opening 105a of the side plates 105, 105'. The first side plate 105 and the second side plate 105' are attached to the base plate 101, so that the assembled housing 107A is properly supported between the two side plates 105, 105'. Those skilled in the art will appreciate that there are various ways to configure the side plates 105 / 105' to support the assembled housing 107A between them.

[0052] The exemplary configuration of the side plates 105 / 105' serves 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 configurations and such configurations are within the scope of the present invention.

[0053] In one embodiment, the crimper 100 includes two housing plates 107 and 107', i.e., a right housing plate and a left housing plate. The housing plates 107, 107' are held between two side plates 105 / 105' mounted on a base plate 101, allowing the housing plates 107, 107' to rotate freely relative to the base plate 101. Both housing plates 107 / 107' of the present invention are mirror images of each other. When assembled, the two housing plates 107, 107' form the housing 107A.

[0054] The structure of one exemplary embodiment of housing plate 107 of the present invention is shown in FIG. 5. The other housing plate 107' is not shown because it is a mirror image of housing plate 107. Both housing plates 107 / 107' may be, for example, circular, and have an inner diameter and a raised edge e1. The raised edge e1 may be, for example, circular. The raised edge e1 gives housing plate 107 / 107' a tray-like (e.g., circular tray) shape with an extended handle portion 107b integrally molded into the raised edge e1. When assembled, the extended handle portion 107b of housing plates 107 and 107' forms handle 109 of housing 107A.

[0055] Either housing plate 107 / 107' may include a central housing opening 107c (or opening 107c). As shown in Figure 5, central housing opening 107c preferably has a circular (or round) shape.

[0056] The housing 107A formed by assembling the two housing plates 107 and 107' in each tray section forms a housing and is used to house the internal components (described below) of the crimper 100. The internal components of the crimper 100 are housed in the space of the housing 107A formed by joining / assembling the two housing plates 107 / 107' (described in more detail below).

[0057] As shown in FIG. 1, the crimper 100 may include multiple jaws 111. In a preferred embodiment of the present invention, the crimper 100 includes twelve jaws 111. However, the number of jaws 111 may be less than or greater than twelve. The jaws 111 move radially in a synchronized manner to collectively form an aperture 111a (or iris aperture), as shown in FIG. 1. The aperture 111a is an iris aperture in the form of a regular polygon that forms a generally circular shape and has a defined size / diameter. The size / diameter of the aperture 111a can be varied in a controlled manner by the movement of the jaws 111 synchronized with the movement of the handle 109.

[0058] As mentioned above, the iris opening 111a is formed by a regular polygon. The number of sides of the polygon is the same as the number of jaws 111. The more jaws 111 there are, the more sides the regular polygon forming the iris opening 111a has, resulting in a smoother, more circular opening. In one embodiment, the iris opening 111a is formed by twelve jaws 111.

[0059] It should be noted that all jaws 111 have the same structure. However, other alternatives, including jaws 111 with different structures, are within the scope of the present invention. FIG. 6 illustrates a single example jaw 111. As shown in FIG. 6, jaw 111 may include a set of grooves 111b and 111b', one on each of its two sides. Linear guides 113a of guide plate 113 / 113' (described below) fit into grooves 111b / 111b'. In one embodiment, the width of each groove 111b / 111b' is sized to match the width of linear guide 113a of guide plate 113 / 113', allowing linear guide 113a to fit within groove 111b / 111b' and jaw 111 to smoothly slide over linear guide 113a.

[0060] The jaws 111 may further have an upper surface 111e with an internally threaded hole 111c. As shown in FIG. 6, the upper surface 111e is flat. The threads can mate with threads on the pin portion of a gear pin 117 (described below). Each jaw 111 has a tapered surface 111d at the end opposite the upper surface 111e. The tapered surfaces 111d of all the jaws 111 form the iris opening 111a when all the jaws 111 are assembled into the guide plate 113 / 113' as described below.

[0061] Each of the housing plates 107 and 107' of the present invention is equipped to hold one guide plate 113 and 113'. In one embodiment, the crimper 100 includes two guide plates 113 and 113', referred to as the "right guide plate" and the "left guide plate." In one embodiment, both guide plates 113 / 113' are mirror images of each other, i.e., guide plate 113' is a mirror image of guide plate 113. When attached to each other, the guide plates 113, 113' form a housing. The jaws 111 and gear pin 117 are housed within the housing formed by assembling the guide plates 113, 113'.

[0062] FIG. 7 shows a single guide plate 113 in a preferred embodiment. The other guide plate 113' is not shown as it is a mirror image of guide plate 113. As shown in FIG. 7, guide plate 113 has a periphery with a predetermined shape, such as the polygonal shape shown in FIG. 7. In some embodiments, the number of sides of the polygon is the same as the number of jaws 111. Each guide plate 113 / 113' may have a raised guide edge 113d shaped as shown in FIG. 7, creating a tray-like shape.

[0063] The outer periphery of the raised guide edge 113d may be polygonal in shape with 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. Alternatively, the outer periphery of the raised guide edge 113d may be circular in shape with an outer dimension smaller than the inner diameter of the gear ring 115.

[0064] The outer periphery of the guide plates 113 / 113' has an outer dimension that is smaller than the inner diameter of the gear ring 115 (described below), thereby allowing the guide plates 113 / 113' to be received within the gear ring 115. Each guide plate 113 / 113' is concentrically fitted within a corresponding housing plate 107 / 107' inside the inner periphery of the gear ring 115, thereby allowing the housing plate to rotate freely relative to the corresponding guide plate 113 / 113'.

[0065] The guide plate 113 / 113' may have multiple linear guides 113a. Each linear guide 113a may be the same or different from the others. In some embodiments, the linear guides 113a are all identical, extending circumferentially from the center of the guide plate 113, as shown in FIG. 7. The other guide plate 113' also has similar linear guides 113a' that mirror the linear guides 113a of the guide plate 113. The linear guides 113a / 113a' of the guide plate 113 / 113' may be rail-like, guiding the movement of the jaws 111. In some embodiments, the number of linear guides 113a / 113a' is equal to the number of jaws 111. In some embodiments, the total number of linear guides 113 / 113' and jaws 111 is 12.

[0066] 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', one on each side. The other groove 111b' of the other jaw 111 engages with a corresponding linear guide 113a' of the other guide plate 113'. This arrangement allows the jaw 111 to 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'.

[0067] The guide plate 113 / 113' may include a guide opening 113b (or central guide opening 113b) in its center and multiple sub-openings 113c in the raised guide edge 113d. In some embodiments, the number of sub-openings 113c is equal to the number of jaws 111. In some embodiments, the guide openings 113b are circular. Similarly, the sub-openings may be approximately semicircular.

[0068] 7, the exemplary guide plate 113 has twelve linear guides 113a for guiding the movement of the corresponding twelve jaws 111. It also has 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 greater than twelve.

[0069] At least one of the housing plates 107 / 107' is provided with a gear ring 115 that is 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, e.g., a "right gear ring" and a "left gear ring." As shown in FIG. 8, the gear rings 115 are circular (round), and if there are two gear rings with side threads 115a, both gear rings 115 are identical. Due to their similar structures, both gear rings are interchangeably referred to 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 one embodiment, 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'. This allows each gear ring 115 to 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 diameter of the guide plate 113. This allows the guide plate 113 to be positioned within the inner circumference of the gear ring 115. The threads 115a of the gear ring 115 mate with the threads of the head portion 117a of the gear pin 117, which will be described below.

[0070] The crimper has multiple gear pins 117. Each gear pin 117 may be the same or different. In one embodiment, all 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, there are 12 jaws 111 and 12 linear guides 113a / 113a', so the crimper 100 has 12 gear pins 117. However, the number of gear pins may be more or less than 12, depending on the number of jaws and linear guides.

[0071] 9 shows an exemplary embodiment of gear pins 117. Each gear pin 117 has an upper rounded 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 rounded head 117a has external threads that mate with the threads 115a present on the gear ring 115. The lower pin portion 117b also has threads 117c that mate with the threads in the hole 111c (described above) in the jaw 111.

[0072] All of the above external / internal components are assembled to form the crimper 100 of the present invention.

[0073] The method of assembly of the aforementioned crimper 100 is shown in FIG.

[0074] The method 10 begins at step 100a where one of the at least one gear rings 115 is concentrically attached to one of the housing plates 107. If another gear ring 115 is present, the remaining gear ring 115 may be attached to another housing plate 107'. An embodiment of the assembly of the right housing plate 107 and gear ring 115 is shown in FIG. 10a, which shows the housing plate 107 resting on the base plate 101. However, assembly does not necessarily have to occur on the base plate 101.

[0075] In one embodiment, when there are two gear rings 115, one gear ring 115 is mounted so that it can freely rotate relative to the housing plate 107 to which it is attached, and the other gear ring 115 is rigidly mounted so that it cannot freely rotate relative to the housing plate 107' to which it is attached. Alternatively, both gear rings 115 can be rigidly mounted to their respective housing plates 107 / 107' so that they cannot freely rotate relative to the housing plate 107 / 107' to which they are attached. In another embodiment, one housing plate (e.g., 107) is provided with a gear ring (e.g., 115) that is rigidly mounted, and the other housing plate 107' is not provided with a gear ring 115. In a preferred embodiment, one gear ring 115 is freely rotatable, and the other gear ring is rigidly mounted so that it cannot freely rotate.

[0076] In step 100b, one of the guide plates 113 is concentrically positioned within the assembly of the housing plate 107 and gear ring 115 of FIG. 10a. Because the outer diameter of the guide plate 113 / 113' is smaller than the inner diameter of the gear ring 115, the guide plate 113 / 113' can be positioned within the inner circumference of the gear ring 115. The guide plate 113 is concentrically positioned 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 plate 113 / 113' are concentric. FIG. 10b shows the assembly with the guide plate 113 mounted in this manner. As shown in FIG. 10b, the guide plate 113 is positioned within the inner circumference of the gear ring 115 mounted to the housing plate 107. In this embodiment, the guide plate 113 is mounted so that the housing plate 107 can freely rotate relative to the guide plate 113. Note that the linear guides 113a extend radially.

[0077] In step 100c, the gear pin 117 and jaws 111 are attached / mounted to the assembly. To clarify this arrangement, the assembly is shown in FIG. 10c, including one gear pin 117 (without 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 threads of the head portion 117a of the gear pin 117 engage with the threads 115a of the gear ring 115 in a threaded engagement (M). Additionally, the pin portion 117b of the gear pin 117 fits within the partial opening 113c in the raised guide edge 113d of the guide plate 113, allowing all gear pins 117 to rotate freely about their respective axes. The gear pin 117 shown has no support and cannot stay in this position. The assembly must lie flat. Figure 10c is shown to illustrate how the gear pin 117 will ultimately be installed.

[0078] To attach the jaw 111 to the gear pin 117, the threads 117c on the pin portion 117b of the gear pin 117 mate with the threads in the hole 111c of the jaw 111 (threaded connection). Figure 10d shows the appearance of one gear pin 117 and one jaw 111. When fitting the jaw 111, care must be taken to align one of the grooves 111b on the jaw 111 with one of the linear guides 113a on the guide plate 113. Note that the gear pin 117 and jaw 111 are not supported and cannot remain in this position as shown. The assembly must lie flat. Figure 10d is shown to illustrate how the gear pin 117 and jaw 111 are finally attached.

[0079] All gear pins 117 and jaws 111 are similarly assembled within the guide plate 113, as shown in FIG. 10e. Because all jaws 111 are positioned to engage the same number of threads as the gear pins 117 with which they are mated, all jaws 111 are the same radial distance from the center of the guide plate 113. When all jaws and gear pins are attached in this manner, the tapered portions of all jaws together form a uniform polygonal iris opening. Furthermore, because the tapered surface 111d of one jaw 111 contacts the corresponding tapered surface 111d of an adjacent jaw 111, the assembly is particularly stable when laid flat. Furthermore, when positioned together in this manner, i.e., when all jaws 111 are the same radial distance from the center of the guide plate 113, the tapered surfaces 111d of all jaws 111 form a central iris opening 111a, as is evident in FIG. 10e.

[0080] In step 100d, a second guide plate 113' is attached to the assembly, securely and concentrically positioned, 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 that accommodates the jaw 111 and the gear pin 117. When attaching the second guide plate 113', note that the linear guide 113a of the second guide plate 113' engages with the second groove 111b' of the corresponding jaw 111.

[0081] As described above, the head portion 117a of the gear pin 117 protrudes from the assembly of the two guide plates 113 / 113' through each partial opening 113c of the two guide plates 113 / 113'. The partial openings 113c of each of the guide plates 113, 113' form complete openings through which the upper portions of the pin portions 117b of all of the gear pins 117 protrude from the assembly of the two guide plates 113, 113'. In this manner, all of the gear pins 117 can freely rotate about their respective axes within these complete openings. In this assembly, the housing plate 107 can freely rotate relative to the guide plates 113 / 113'.

[0082] In step 100e, a second housing plate 107' (the other housing plate 107') is concentrically positioned and mounted in the above assembly to align with the first housing plate 107, as shown in Figure 10g, such that the central housing opening 107c (in both housing plates 107) and the guide openings 113b (in both guide plates 113 / 113') are concentric. When mounting the second housing plate 107', care is taken to ensure that the threads of the other gear ring 115 (if provided) in the second housing plate 107' engage with the threads of the head 117a of the gear pin 117, allowing the second housing plate 107' to rotate freely relative to the assembly of guide plates 113 and 113'. The housing plates 107 and 107' are fixedly attached to each other to form the housing 107A such that, after attachment, the handle portions 107b of the two housing plates 107 and 107' form a complete handle 109 and the housing 107A is free to rotate relative to the assembly of the two guide plates 113 and 113'.

[0083] In step 100f, side plates 105 and 105' are attached to the assembly, as shown in FIG. 10h. Side plates 105 and 105' are positioned on either side of the assembly consisting of the combination of housing 107A and guide plate 107 / 107' with all internal components. The central opening 105a of side plate 105 / 105' is concentric with central housing opening 107c of housing plate 107 / 107' and guide opening 113b of guide plate 113 / 113'. This arrangement forms the central round opening Y shown in FIG. 10h. In one embodiment, side plate 105 / 105' is rigidly attached so that housing 107A can freely rotate relative to side plate 105 / 105' and guide plate 113 / 113' about the central round opening Y. The assembly of side plate 105 / 105', housing plate 107 / 107' and guide plate 113 / 113' is mounted on base plate 101, and while the assembly of side plate 105 / 105' and guide plate 113 / 113' is mounted, housing 107A is free to rotate about the central round opening Y by moving the handle up or down.

[0084] Thus, the central housing opening 107c of the housing plate 107 / 107' and the guide opening 113b of the guide plate 113 / 113' are aligned to receive the radially expandable and collapsible prosthetic device within the iris opening 111a.

[0085] The above assembly is fitted with an optional removable stopper 103, as shown in FIG. 10i. FIG. 10i shows the crimper 100 set in a vertical position with the stopper 103 restricting the movement of the handle 109 on the housing plate 107. The handle 109 cannot be moved further downward, limiting the minimum size / diameter of the opening 111a corresponding to the lowest position of the handle 109 restricted by the stopper 103. Moving the handle 109 upward increases the size / diameter of the opening 111a, with the uppermost position having the largest diameter. Retracting the stopper 103 reduces the minimum size / diameter of the opening 111a. Without the stopper 103, the handle 109 would have no restriction on further downward movement, and the size / diameter of the opening 111a would be reduced to a very low value.

[0086] The crimper 100 disclosed above operates in a predetermined manner, as described below. Movement of the handle 109 imparts rotational motion to the housing 107A around the central circular opening Y and to the internal components disposed within the housing formed by the two guide plates 113 and 113′. This rotation causes the gear ring 115 to rotate, which in turn causes the head portion 117a of the gear pin 117 to rotate. The pin portion 117b of the gear pin 117 also rotates within the internal threads of the holes 111c in the upper surfaces 111e of the jaws 111, causing the jaws 111 to slide radially and linearly along the linear guides 113a / 113a′ of the guide plates 113 / 113′ in unison. This movement of the jaws 111 causes the size (contraction or expansion) of the opening (iris opening) 111a formed by the tapered surfaces 111d of the jaws 111 to change. Moving the handle 109 upward rotates the gear ring 115 in the same direction. This action rotates the gear pin 117, moving the jaws 111 apart, increasing the size / diameter of the iris opening 111a. Moving the handle 109 downward similarly moves the jaws 111 closer together, decreasing the size / diameter of the iris opening 111a.

[0087] The crimping method using the crimper 100 of the present invention involves placing the crimped medical device (in an at least partially expanded state) over a deflated balloon of a delivery system. If necessary, the balloon can be partially inflated to better secure the medical device to the balloon. The handle 109 of the crimper 100 is then moved upward to increase the size of the iris opening 111a to a size greater than the diameter of the prosthetic device in its at least partially expanded state. The balloon and prosthetic device are at least partially inserted / positioned into the iris opening 111a of the crimper 100. The handle 109 is then gradually moved downward to decrease the size of the iris opening 111a and reduce the diameter of the prosthetic device, i.e., crimp the prosthetic device. This downward movement is manually controlled to incrementally reduce the size of the iris opening 111a. Alternatively, this downward movement can be automated. The downward movement of the handle 109 is stopped when the desired crimping is achieved. This can also be done in multiple steps. The crimped diameter of the prosthetic device can be controlled by either discreetly stopping the downward movement of the handle 109 or limiting further downward movement with the stopper 103 .

[0088] At this stage, the handle 109 is moved upward to increase the size of the iris opening 111a and the balloon-crimped prosthetic device is removed from the opening 111a of the crimper 100.

[0089] The crimped prosthetic device is then inspected to ensure the desired level of crimping has been achieved. If more crimping is required to further reduce the crimp diameter, the crimping operation is repeated, moving the handle further downward than its previous position.

[0090] The scope of the present invention is limited only by the appended claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are exemplary only, and that the actual parameters, dimensions, materials, and / or configurations will vary depending on the particular application or uses for which the teachings of the present invention are used.

Claims

1. 1. A crimping device for crimping a radially expandable and collapsible prosthesis to reduce its diameter from an at least partially expanded state to a crimped state, the crimping device comprising: A base plate and two housing plates mounted on the base plate so as to rotate freely relative 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, wherein when the two housing plates are assembled, the tray portion of each housing plate forms a housing for accommodating other components of the crimping device, and the handle portion of each housing plate forms a handle; and at least one of the two housing plates is provided with a circular gear ring mounted concentrically inside the housing plate; two housing plates, the gear ring having a screw thread, the gear ring having an inner diameter defining an inner periphery and an outer diameter defining an outer periphery; two guide plates attached to one another to form a housing, each guide plate concentrically received within a respective housing plate inside an inner periphery of said gear ring so that each housing plate can rotate freely relative to its respective guide plate, each guide plate having a central guide opening and a plurality of identical linear guides extending radially outward from a central portion of the guide plate, each linear guide having a width and a length; a plurality of identical jaws, each jaw having a top surface, a tapered surface, and two side surfaces, each jaw comprising: (a) a hole in the top surface, the hole having an internal thread; (b) two grooves on each of the two sides 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 plurality of identical jaws, further including tapered surfaces, each of which collectively defines an iris opening when all of the jaws are assembled, the size of the iris opening varying with synchronized, controlled movement of the jaws upon movement of the handle; a plurality of identical gear pins, each having a head portion and a threaded pin portion, the head portion having external threads that mate with threads of the gear ring, the threads of the pin portion mate with threads of a hole in an upper surface of the jaw; a central housing opening in the housing plate and a central guide opening in the guide plate align with one another to receive the prosthesis within an iris opening formed by the jaws for crimping the prosthesis; a crimping device in which, when the handle is moved, the housing plate rotates around the central circular opening, rotating the gear ring, which in turn rotates the head of the gear pin, causing the threads of the pin portion of the gear pin to rotate within the internal threads of the holes in the upper surfaces of the jaws, causing the jaws to move radially along linear guides in the guide plate and changing the size of the iris opening.

2. 2. The crimping device of claim 1, wherein the housing plate is held between two side plates and attached to the base plate such that the housing plate is free to rotate relative to the side plates.

3. 2. The crimping device of claim 1, wherein each housing plate has an inner diameter and a raised edge.

4. 2. The crimping device of claim 1, wherein said gear ring has an outer diameter smaller than an inner diameter of said raised edge of said housing plate.

5. 2. The crimping device of claim 1, wherein the diameter of each head portion of said gear pin is greater than the diameter of the pin portion of said gear pin.

6. 2. The crimping device of claim 1, wherein the guide plate has a raised guide edge, the guide edge having a circular shaped outer periphery with an outer diameter smaller than an inner diameter of the gear ring.

7. 2. The crimping device of claim 1, wherein said guide plate has a raised guide edge, said guide edge having a polygonal shaped outer periphery with an outer diameter smaller than an inner diameter of said gear ring.

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

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

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

11. 2. The crimping device of claim 1, wherein the number of linear guides in each guide plate, the number of said gear pins, and the number of said jaws are each greater than or less than twelve.

12. 12. The crimping device according to claim 1, wherein the gear ring is fixedly attached to one of the two housing plates, the other housing plate being free of a gear ring.

13. 13. A crimping device according to any one of claims 1 to 12, wherein a respective gear ring is mounted on each housing plate, one gear ring being free to rotate and the other gear ring being fixed to said housing plate.

14. 2. The crimping device of claim 1, wherein each gear ring is fixedly attached to a respective housing plate.

15. 15. The crimping device according to any one of claims 1 to 14, wherein the gearing is mounted on one of the two housing plates so that the gearing rotates freely, the other housing plate having no gearing.

16. 16. The crimping device of any one of claims 1 to 15, wherein the crimping device is made from a polymeric material, a metallic material, or a combination of these materials.

17. 17. The crimping device of claim 1, wherein the base plate includes one or more stops, fixedly or removably attached to the base plate, that limit downward movement of the handle to define a lowest position of the handle and prevent further reduction in the size of the iris opening.

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

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

20. 1. A method of assembling a crimping device, comprising: attaching a gear ring to at least one of the plurality of housing plates; concentrically disposing a first guide plate within an inner periphery of the gear ring such that the housing plate rotates freely relative to the guide plate; attaching a plurality of gear pins to each guide plate such that a head of each gear pin threadably engages with a gear ring, and after engagement, each gear pin is free to rotate on its respective axis; a suction step of aligning each groove of a plurality of jaws with a respective linear guide of the first guide plate and simultaneously attaching each jaw to a respective pin portion of the gear pin by a threaded connection, so that the plurality of jaws form a uniform polygonal iris opening, and all jaws engage with the same number of threads of the pin portion, thereby causing all jaws to be at the same radial distance from the center of the first guide plate; concentrically disposing and fixedly attaching a second guide plate to the first guide plate to form a housing in which the gear pin and jaw are attached; placing the other housing plate concentrically on the second guide plate such that the other housing plate rotates freely relative to the first guide plate assembly; and fixedly attaching the two housing plates to one another to form a housing including a handle formed by the handle portions of the two housing plates after attachment.

21. 21. The method of claim 20, wherein the step of attaching the gear rings includes attaching one gear ring to one of the housing plates so that the gear ring is either free-rotating or fixedly attached.

22. 21. The method of claim 20, wherein the step of installing the plurality of gear pins includes the step of engaging a head portion of each gear pin protruding from the first guide plate with threads of a gear ring installed within the housing plate.

23. 21. The method of claim 20, wherein the step of attaching the plurality of gear pins includes threading a pin portion of each gear pin into internal threads of a hole in an upper surface of a jaw.

24. 21. The method of claim 20, wherein aligning each of the grooves of the plurality of jaws with a respective linear guide of the first guide plate includes interlocking each groove on a side of each jaw with a respective linear guide of the guide plate.

25. 21. The method of claim 20, wherein the plurality of jaws forming a uniform polygonal iris opening comprises attaching tapered surfaces of all of the jaws to the guide plate to form a uniform polygonal iris opening.

26. 21. The method of claim 20, wherein positioning the second guide plate includes engaging a plurality of second grooves of the jaws with linear guides of the second guide plate to leave a head of the gear pin protruding from the second guide plate assembly so that the gear pin rotates freely along each axis.

27. 21. The method of claim 20, wherein concentrically positioning the other housing plate over the second guide plate includes engaging threads on a head of the gear pin with threads on a gear ring disposed within the other housing plate.

28. One or more side plates are attached to each side of the housing plate, the openings in the side plates are concentric with a central housing opening in the housing plate, the guide openings in the guide plates form a central circular opening, and the housing plate is free to rotate about the central round opening relative to the side plates and the guide plates.

21. The method of claim 20, comprising the step of:

29. 21. The method of claim 20, wherein the side plate, housing plate, and guide plate assembly are mounted to a base plate, the side plate and guide plate assembly being stationary, and the housing plate assembly being free to rotate about a central round opening by moving the handle up or down.

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

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

32. 21. The method of claim 20, wherein the step of attaching the gear rings includes the step of fixedly attaching one gear ring to each housing plate while allowing the other gear ring to rotate freely.

33. 1. A method of assembling a crimping device, comprising: Mounting a gear ring in at least one of the housing plates, the gear ring either freely rotating within the housing plate or fixedly mounted thereto; concentrically disposing a first guide plate within the housing plate with the gear ring attached thereto, such that the housing plate is free to rotate relative to the first guide plate; installing a plurality of gear pins such that the head of each gear pin remains protruding from the first guide plate and the external threads of the gear pin head engage with the threads of a gear ring attached to the housing plate, allowing all gear pins to rotate freely on their respective axes; threading pin portions of the gear pin into the internal threads of holes in the upper surfaces of the jaws, and attaching the jaws to the gear pin so that each groove on the side of each jaw engages with each linear guide on a guide plate, the jaws are arranged so that they engage with the same number of threads on the gear pin, all jaws are the same radial distance from the center of the guide plate, and all jaws and gear pins are attached so that the tapered surfaces of all jaws form a uniform polygonal iris opening; placing a second guide plate concentrically over the first guide plate to form a housing in which the gear pin and jaws are mounted, with the grooves of the second guide plate engaging with the second grooves of the jaws, with the head of the gear pin remaining protruding from the assembly of the two guide plates, and with the gear pin free to rotate along its respective axis; placing the other housing plate concentrically over the second guide plate and engaging the threads of the gear ring in the other housing plate with the threads of the head of the gear pin so that the other housing plate rotates freely relative to the assembly of the two guide plates; fastening and mounting both housing plates so that after mounting, the housing is formed, the handle portions of the two housing plates form a complete handle, and the assembly of the two housing plates is free to rotate relative to the assembly of the two guide plates; attaching a side plate to each side of the housing plate and guide plate assembly, the central opening of the side plate being concentric with the central housing opening of the housing plate and the guide opening of the guide plate to form a central round opening, the housing plate assembly being free to rotate relative to the side plate and the guide plate about the central round opening; fixedly attaching side plates to each other and to said guide plate such that said housing plate assembly is free to rotate relative to said side plates and said guide plate about a central circular opening; and mounting the side plate, housing plate, and guide plate assembly on a base plate, so that the side plate and guide plate assembly is stationary and the housing plate assembly is free to rotate about a central round opening; wherein movement of the handle rotates the housing plate about the central round opening, rotating the gear ring, which in turn rotates the head of the gear pin, causing the threads of the pin portion of the gear pin to rotate within the internal threads of the holes in the top surfaces of the jaws, causing the jaws to move radially along linear guides in the guide plate and changing the size of the iris opening.

34. 20. A method for crimping a radially collapsible expandable prosthesis using a crimping device according to any one of claims 1 to 19, comprising the steps of: moving the handle upward to increase the size of the iris opening formed by the jaws until the size of the iris opening is larger than the diameter of the prosthesis being crimped; placing the prosthesis in the iris opening in an at least partially expanded state; gradually moving the handle downward to reduce the size of the iris opening and crimping the prosthesis in one or more steps; controlling the crimped diameter of the prosthesis by determining whether or not to stop the downward movement of the handle, or by further limiting the downward movement of the handle with a stopper of the crimping device according to claim 17; moving the handle upward to increase the size of the iris opening; and removing the crimped prosthesis from the iris opening.

35. 35. The method of claim 34, wherein the prosthesis is balloon expandable.

36. 35. The method of claim 34, wherein placing the prosthesis in the iris opening in an at least partially expanded state comprises placing the crimped prosthesis over a deflated balloon in the iris opening.

Images