SET COMPRISING A CATHETER AND A VALVE SUPPORTING IMPLANT

The present invention relates to a set according to the preamble of claim 1. The invention further relates to a method used for detachably attachment or interconnection of a medical implant with an implantation device according to claim 10 and to a method for releasing a medical implant at an implantation site according to claim 12.

In medicine, stents, or implants in general, are used for keeping vessels (especially: blood vessels) or tubes (especially trachea, esophagus, stomach, intestine, urethra, ureter) open or for replacing the function of a defect valve. They are inserted or advanced, respectively, to the implantation site in a folded or collapsed, respectively, or crimped manner by using an implantation device, for example a catheter. At this site, the unfolding or decollapsing, respectively, of folded or collapsed stents is effected for example by removing an outer sleeve, which is arranged over or about the folded or collapsed implant, by means of reset or restoring forces; or by means of a balloon arranged inside the implant, which expands the implant encircling or encompassing the balloon when being inflated or blown up, respectively.

The object of the present invention is to propose another medical set or arrangement for inserting and/or manipulating an implant or a device comprising such a medical implant, in particular a valve supporting implant, for example a heart valve, to and/or at an implantation site.

The object according to the invention is solved by the feature combination of claim 1. This object is also solved by the feature combination of claims 10 and 12.

Thus, according to the invention, there is proposed a medical set or arrangement comprising at least one expandable and/or decollapsible or unfoldable medical implant and at least one implantation device, for example a catheter, for detachably receiving the implant or a device comprising at least such an implant. Thereby, the implant may comprise at least a valve and/or may be designed, configured as and/or composed from at least from a valve supporting implant. Further, the valve may be designed or configured so as to fulfill a check valve function, for example the valve may be configured as a check valve with at least a conducting direction (CD) and at least a blocking direction (BD). Further, the valve may comprise a blocking element which may move for opening and/or, in particular reversibly, closing and/or opening the valve. Further on, the valve may be arranged, connected and/or fixed on, in or onto the implantation device and/or the implant such that at least one or the conducting side of the check valve is located, arranged or positioned at a smaller distance from the distal end or from the distal tip of the implantation device than one of the blocking side.

In other words, the valve may be arranged with its flowing through direction being orientated from the distal end to the proximal end of the implantation device.

That may mean that at least one or the conducting side of the check valve may be located or arranged before at least one or the blocking side of the valve in a direction from a distal end to a proximal end of the implantation device.

In an alternative embodiment of the present invention, there is proposed a medical set or arrangement comprising at least one expandable and/or decollapsible or unfoldable medical implant and at least one implantation device, for example a catheter, for detachably receiving the implant or a device comprising at least such an implant. Thereby, the implant may comprise at least a valve and/or may be designed or configured as or composed at least from a valve supporting implant. Further, the valve may be designed or configured so as to fulfill a check valve function, for example the valve may be configured as a check valve with at least a conducting direction and at least a blocking direction. Further, the valve may comprise a blocking element which may move for opening and/or closing the valve. Further on, the valve may be arranged and/or connected and/or fixed on, in or onto the implantation device such that at least one or the blocking side of the check valve is located or arranged or positioned at a smaller distance from the distal end or from the distal tip of the implantation device than one or the conducting side of the valve.

In other words, the valve may be arranged with its flowing through direction being orientated from the proximal end to the distal end of the implantation device.

That means that at least one or the blocking side of the check valve may be located or arranged before at least one or the conducting side of the valve in a direction from a distal end to a proximal end of the implantation device.

Further, according to the invention, a method for detachably attach, temporarily fix and/or detachably interconnect a medical implant on or with an implantation device may comprise at least the steps of providing an implantation device and a medical implant, wherein the implant may comprise at least a valve configured to fulfill a check valve function and of detachably attaching, fixing or interconnecting the implant on or with the implantation device. Thereby, the at least one or the conducting side of the valve may be located or arranged before at least one or the blocking side of the valve in a direction from a proximal end to a distal end of the implantation device, or, in other words, such that at least one or the conducting side of the check valve may be located, arranged or positioned at a smaller distance from the distal end or from the distal tip of the implantation device than the blocking side.

In an alternative embodiment of the present invention, there is proposed a method for detachably attach, temporarily fix and/or detachably interconnect a medical implant on or with an implantation device. The method may comprise at least the steps of providing an implantation device and an implant, wherein the implant may comprise at least a valve configured to fulfill a check valve function and of detachably attaching, fixing or interconnecting the implant on or with the implantation device. Thereby, the at least one or the blocking side of the valve may be located or arranged before at least one or the conducting side of the valve in a direction from a distal end to a proximal end of the implantation device, or in, other words, such that one or the blocking side of the check valve may be located arranged or positioned at a smaller distance from the proximal end or from the proximal tip of the implantation device than the conducting side.

Finally, the present invention relates to a method for releasing an implant from an implantation device at an implantation site using a set according to the present invention. The method comprises at least the steps of expanding, unfolding and/or decollapsing, respectively, a crimped or folded implant from a first diameter to a second diameter and disconnecting a device comprising the implant and/or the implant at a site that is different from a connection site at which the implant or the device comprising the implant has been connected to or attached on the implantation device.

Further advantageous embodiments and developments of the present invention are each subject-matter of the dependent claims.

Embodiments of the present invention can include additionally or alternatively one or more of the preceding and/or following features independently of any other feature, i. e., without having to comprise any other feature in combination.

Whenever the expression “can”, “may be” or “may have”, and so on is used herein, it is to be understood synonymously with “in exemplary embodiments is” or “in exemplary embodiments has”, “preferably is” or “preferably has” respectively, and so on, and is intended to illustrate exemplary embodiments.

In the following, the expression “distal end” may be understood as the end of the implantation device or of a receiving device for the implant which is intended to be inserted. The expression “proximal end” may be understood as the end of the implantation device or receiving device opposite to the distal end, in other words, the end which will be orientated to and manipulated by a surgeon or operator.

Whenever numerical values are mentioned herein such as “one”, “two” and the like, they have to be understood as values representing the lower threshold of numerical ranges. A long as this does not result in a contradiction in the eyes of the skilled one, numerical values, such as “one” shall be understood as comprising also “at least one”. This interpretation or understanding is as well encompassed by the present invention as the understanding according to which a numerical value such as “one” may be understood as “exactly one” whenever this appears technically possible to the skilled person. Both understandings are covered by the present invention. This applies to any numerical value stated herein.

Whenever reference is made within the present specification to a check valve, it is to be noted that the term “check valve” is used by way of an example for a valve having at least the function of and/or being at least configured for permitting a fluid, like gas or liquid, to flow through the valve in a particular direction and to prohibit or prevent such a flow in another, in particular reversed direction.

Whenever reference is made within the present specification to an implantation device, it is to be noted that this term is used by way of example for a delivery implement, catheter or device for delivering the implant to an implantation site. However, the present invention is not to be understood to relate only to catheters—rather, any suitable device for advancing an implant to its implantation site is also contemplated by the inventors.

According to the invention, expanding, unfolding or decollapsing, respectively, is understood as enlarging or increasing the diameter of the implant. Thereby, the non-expanded or non-unfolded or non-decollapsed, respectively, diameter (which can also be referred to as a first diameter, wherein also another diameter which is smaller than the second diameter mentioned below can be understood as a first diameter in the sense of the present invention) can be a diameter of the implant immediately before its insertion into the patient's body. In returning the diameter back from a second diameter (which is larger than the first diameter) to an arbitrary reduced diameter (the first diameter), the diameter is diminished or reduced, respectively. Returning (back) can be accomplished by a (completely or partly) re-folding or a reversed expanding procedure. According to the invention, during the returning procedure, the implant does not necessarily have to be brought into a shape that it occupied or passed through during unfolding or expanding.

According to the invention, altering the shape of the implant may mean reducing or increasing a diameter, particularly an external diameter, of the implant. Such an alteration can or cannot involve an alteration of the implant's length or any other kind of alteration.

In some embodiments according to the invention, the set comprises the devices that are necessary and provided or configured for executing the method(s) according to the invention. This especially applies for the devices mentioned in relation with the method(s) disclosed herein. A set may comprise—as any other device according to the present invention and/or any other device comprised in the set or parts thereof—at least one or more devices suited and/or configured and/or adapted such that one, more or all steps mentioned therein can be executed by the respective device.

In some embodiments of the present invention, folding the implant may mean reducing the diameter of the implant.

According to the present invention, the check valve may at least have a conducting direction and at least a blocking direction. A fluid flowing in the conducting direction of the check valve will be able to pass through the conducting side of the check valve wherein a fluid flowing in the reverse or in the blocking direction of the check valve will not be able to pass through the check valve, but will be retained or stopped, at least partly, from the blocking side or element of the check valve.

In certain embodiments of the present invention the blocking direction is a direction opposite to the conducting direction.

In some embodiments, the diameter of the implant is arranged in one plane perpendicular to a main flow direction of the implant in case fluids flow through the implant after its implantation.

In case a diameter of the implant could not be determined, expanding, unfolding or decollapsing, respectively, is understood as an increase in a direction or dimension of the implant which effects an elongation of a periphery or circumference, respectively, of the implant in a plane perpendicular to the longitudinal direction of the implant explained further below.

According to the invention, receiving an implant or a device comprising an implant by the implantation device is understood as any functional connection between the implant and the implantation device. Thereby, a transmission of power or forces, respectively, can take place, but does not have to take place. The connection can be provided as a frictional or form closure connection or neither as a frictional nor as a form closure connection.

According to the invention, “detachably receiving” is understood as a separable or dividable conjunction or association between the implantation device and the implant. An example for a separable or dividable conjunction is crimping a stent onto an implantation device for advancing or inserting the stent to the implantation site.

In some embodiments of the present invention, the implantation device comprises at least one means or an apparatus for controlling the expansion, the folding and/or the unfolding, respectively, of the implant, in particular from a first diameter to a second diameter and/or for returning back the implant from the second diameter to the first diameter; alternatively the implantation device is prepared for receiving such a means.

According to the invention, “controlling” also includes adjusting or setting or regulating, respectively. Thereby, it can be adjusted or set or regulated, respectively, to a voltage value, a pressure value or the like.

According to the invention the implantation device advantageously allows for a controlled unfolding or decollapsing, respectively, and re-folding or re-collapsing, respectively, (which can also encompass or include expanding and returning back to a reduced diameter) of the implant, for example, when being arranged inside the implant. Thus, it is advantageously possible to return or bring the implant back to a smaller diameter again and thus re-implant it after its expansion or unfolding, i. e., to shift it at the implantation site. If there should be detected during implantation that an implant of wrong size or design or construction, respectively, had been chosen, the implant could advantageously be replaced even after its expansion/unfolding.

In certain embodiments of the present invention, the implantation device may be connected to or communicate, respectively, with the implant via the means for controlling.

In particular embodiments, the unfolding or decollapsing, respectively, and the folding or collapsing, respectively, of the implant can be performed without the aid of an outer sleeve.

In some embodiments of the present invention, the implantation device may comprise a plastic or synthetic material or a copolymer or can be manufactured by means of two- or multiple-component technologies. According to the invention, the implantation device may comprise a metal (steel or alloy). The implantation device may be stiff; however, it may also be designed flexible or bendable, in order to be able to adapt it to or align it with defined or certain conditions. Thereby, the implantation device may be manually bendable or it can be controlled for bending by means of a mechanism which can, e. g., be integrated in the implantation device. The implantation device may be bendable in a passive manner, e. g., by advancing or inserting it along the vessel or body lumen alone.

In certain embodiments of the present invention, the implantation device may comprise a mechanically enforced or reinforced section, in particular in a tip area of the implantation device, and in particular in a section which also comprises at least one passage means.

In some embodiments of the present invention, the implantation device may have a circular or oval or rectangular cross-section. The implantation device can also have a non-circular, a non-oval or a non-rectangular cross-section. Furthermore, the cross-section of the implantation device can be unchanged across the whole implantation device. However, it can also have two or three or more different cross-sections along its longitudinal axis and in particular in the area for receiving the implant.

In certain embodiments of the present invention, the unfolding and folding of the implant which is controlled by the implantation device can take place outside and/or inside a patient's body.

In some embodiments of the present invention, the implantation device can be designed such as described in, e.g., US 2007/0100427 A1 by Perouse or in US 2005/0075731 A1 by Artof et al. By way of reference, the contents thereof are each subject-matter of the present invention. This particularly applies for the materials and (part) geometries given therein.

In certain embodiments of the present invention, the implantation device can be a one-lumen implantation device; it can have no lumen and it can be a multi-lumen implantation device. If it is a multi-lumen implantation device, the implantation device can be a two- or three- or multi-lumen implantation device having equally or differently sized lumina in or regarding its cross-section.

In some embodiments of the present invention, the implantation device has a plurality of lumina in longitudinal direction or channels (hereinafter also designated in short: channel or channels) for guiding tension threads or reins. The lumina or channels may serve for organizing and/or arranging or aligning, respectively, the tension threads. They can advantageously assure that the physician is always able to determine which one of the optionally same looking tension threads he holds in his hand or wants to operate. Hereto, he has only to orientate from which channel the respective tension thread comes out or leaves, respectively, or into which channel the tension thread enters.

In certain embodiments of the present invention, the channels can serve for avoiding any disorientation or tangling, entangling, knotting or interloping, respectively, etc. of the tension threads with each other.

In some embodiments of the present invention, tension threads serving for the same or a common purpose during operation can be combined in the respective channels. Thus, tension threads which all have to be operated for effecting a certain behavior of the implant and/or of a device comprising the implant and/or of the implantation device can be guided through one channel. Tension threads which have to be operated for effecting another behavior of the implant and/or of a device comprising the implant and/or of the implantation device can be guided, through another channel. Obviously, using the tension threads facilitates the operation of the implant and/or of a device comprising the implant and/or of the implantation device by the physician.

In certain embodiments of the present invention, tension threads running to the implant can also be separated from tension threads running back from the implant.

In some embodiments of the present invention, providing the tension threads in a plurality of channels and their guidance therein can avoid a mutual interaction or interference, respectively, or the risk thereof. With the corresponding arrangement of the tension threads in separate channels it can, for example, be assured that, by pulling one tension thread running in a first channel, another tension thread is not unintendedly operated due to friction or any other interaction of the pulled tension thread with this other rein.

In certain embodiments of the present invention, providing a plurality of channels for separately guiding tension threads can advantageously enable a separation of tension threads and other means such as, for example, a guiding wire. The function of the tension threads is thus not impacted or influenced, respectively, by further means and functions of the implantation device, but—and this is not less advantageous—also vice-versa; i. e., it can also advantageously be avoided that the further means such as a guiding wire is impacted or influenced, respectively, by the presence or operation of the tension threads of the implantation device.

In some embodiments of the present invention, providing a plurality of channels for separately guiding tension threads can thus advantageously increase the precision during operation of the tension threads and thus the use of the implantation device and/or of the implant.

In certain embodiments of the present invention, the implantation device comprises at least one passage means for letting pass one or more tension threads.

In particular embodiments, the tension threads can serve for influencing the expansion, folding and/or unfolding of the implant by changing a tension or stress, respectively, that is applied on the implant by the tension thread.

According to the invention, “letting pass” is also understood as “passing” or “guiding through”.

In some embodiments, a passage means may be a passage opening, an eye or loop, respectively, a deflecting or diverting section or the like.

In particular embodiments of the present invention, a tension thread can comprise a polymer, a metal or a biological fiber material or can consist thereof. The tension thread or the tension threads can be optionally absorbable.

According to the invention, a tension or a stress, respectively, which is applied to the implant by the tension thread, is also understood as a strain or in general any effect of the tension thread on the implant.

Whenever the present application refers to a tension thread, there can be meant more than one tension thread, for example, two, three, four, five or more tension threads.

In some embodiments of the present invention, the tension threads can also be provided functionally separated from the implantation device.

In certain embodiments of the present invention, the implantation device can comprise an inner guiding means for the at least one tension thread.

In some embodiments of the present invention, the tension threads can leave or get out of the implantation device at one side and/or at one end of the implantation device through one or more passage means (especially, when those are designed as passage openings). Those passage means can be present in or on one or several planes perpendicular to the longitudinal axis of the implantation device.

In certain embodiments of the present invention, the implantation device can comprise a device for cutting or tearing through the tension threads.

In some embodiments of the present invention, the implant may be configured as a valve supporting implant or may be composed of at least one valve.

In certain embodiments, the implant may comprise at least one foldable or collapsible or crimpable and unfoldable or expandable structure on or around or over a portion or outer surface of the implantation device or of part thereof.

In some embodiments the implant can be a stent or comprises a stent, in particular a valve supporting stent, or may be configured as a cardiac valve, a heart valve prosthesis, substitute or replacement thereof.

In particular embodiments, the implant comprises flexible leaflets.

In certain embodiments of the present invention, an implant, in particular a stent, is proposed, which comprises at least one means which is provided or prepared with the means of an implantation device for controlling the expansion, folding and/or unfolding of the implant, in particular from a first diameter to a second diameter and/or the return back from the second diameter to the first diameter in order to control the change of the diameter.

In some embodiments of the present invention, the implant comprises at least one guiding means which is prepared and suited for guiding at least one tension thread by which at least one section of the implant is expandable and/or decollapsible or unfoldable, respectively, from the first diameter to the second diameter and/or is returnable back from the second diameter to the first diameter by changing the tension or stress, respectively, or the strain applied to the tension thread.

In certain embodiments of the present invention, the implant can be self-expanding, for example, it can be formed from or with a memory material, in particular nitinol, or materials which comprise nitinol. However, the implant can also be partly self-expanding, partly expandable by the use of an expanding means. The implant can exclusively be non-self-expanding. The implant can be foldable; the implant can be non-foldable.

In some embodiments of the present invention, the implant can comprise a biocompatible material, in particular a biocompatible stainless steel. The material can be bio-absorbable.

In certain embodiments of the present invention, the implant can be designed with or without a means for encompassing or sandwiching parts of native valve sections (in particular heart valve leaflets). In particular, the implant can be designed with or without sections rising up or lowering down due to temperature and memory effect.

In some embodiments of the present invention, the one or several guiding means of the implant can be designed in form of guiding holes, guiding rings, eyes or loops, respectively, hooks or, generally spoken, guiding structures. They confer guidance to the rein which can be understood in the sense of directing the rein in one direction.

According to the invention, guidance can also be understood such that the rein experiences stabilization along its extension. Thereby, the rein can be guided or directed, respectively, by the guiding means from an interior of the implant or stent, in particular from the implantation device, to the implant structure (in particular to the exterior of the implant). The guiding means of the implant can be symmetrical (in particular circular, oval or square) or asymmetrical. The guiding means can be located on one plane, on several planes or on a spiral plane of the implant. Several guiding means can be designed equally or can be present in at least two different designs.

In certain embodiments of the present invention, the implant or the stent can comprise a circular guiding means. The said can be designed in form of a channel which is, relative to the implant, open or closed to the outside, to the top or to the bottom. The guiding means can be closed or open and can have a symmetrical or asymmetrical form. The guiding means can be designed in form of a grid structure, a meander structure, a sinus wave structure, in particular one comprising 18 wave tips along a periphery, or the like. The guiding means can have a structure without a grid and/ok without a meander and/or without a sinus wave structure. However, it can also comprise a sinus wave structure having a number of wave tips other than 18.

In some embodiments of the present invention, the implant can be a valve supporting stent and made from steel such as described in the U.S. Pat. No. 5,411,552, U.S. Pat. No. 5,840,081 and U.S. Pat. No. 6,168,614 B1 by Andersen et al. The stent can, however, also be a valve supporting self-expanding stent according to the disclosure of U.S. Pat. No. 7,018,406 B2 by Seguin et al. or of US 2005/0075731 A1 by Artof et al. The contents of the afore-mentioned documents are by way of reference herewith also subject-matter of the present invention or application, respectively. This particularly applies for material and (part) geometries of the implants and stents disclosed therein.

In certain embodiments of the present invention, the tension threads can be guided or directed, respectively, along an interior of the implantation device and can leave or get out of the implantation device through the passage means. Then, the tension threads can be guided through the guiding units at or on the implant. The tension threads can be guided along a periphery or parts of a periphery in the guiding unit along the circumference of the implant. Then, the tension threads are guided back from outside through the passage means to the interior of the implantation device. The tension threads can leave the implantation device at its end proximal to the surgeon. The tension threads can leave the implantation device at its end distal to the surgeon. The effect and in particular the strain of the tension threads and thus the controlled unfolding and the re-folding or reduction in the diameter of the stent can be controlled by means of a controlling means.

In some embodiments of the present invention, a tension thread can leave the implantation device via a passage means arranged at the implantation device and can be guided back into the implantation device via the same passage means or via another passage means on the same or on another plane.

In certain embodiments of the present invention, the tension threads can leave the implantation device with their both ends.

In some embodiments of the present invention, the tension threads can leave the implantation device with one end and can be connected to the implantation device with the other end.

In certain embodiments of the present invention, the tension threads can be pulled back from the implant or stent and removed after cutting or tearing through or disengaging or notching, respectively, or by using any other kind of detaching or loosening the tension threads.

In some embodiments of the present invention, the tension threads can be cut or torn through by means of a device in the implantation device, a device inside or outside the implantation device (in particular a knife, a pair of scissors, by means of electrical voltage, by means of heat). A suited device can be arranged at or on the implantation device.

In certain embodiments of the present invention, the stent is unfolded or expanded with little or without any tension of the tension threads. With tension being present, the stent is reduced in its diameter or is partly or completely re-folded.

In particular embodiments of the set, the implantation device is arranged in the center or substantially in the center of a cross-section or of any cross-section of the implant and/or of the valve.

In some embodiments of the present invention, this center or central arrangement can relate to a state of use. It can relate to a non-unfolded or non-expanded state. It can, however, also relate to a completely expanded or unfolded state.

In certain embodiments of the present invention, the state of use can be a state during positioning the implant—in particular during its rotation around a rotation center thereof—in order to precisely form the desired positional relation between the implant and the anatomic site at which the implant shall be implanted or come to rest in the body.

In some embodiments of the present invention, arranging the implantation device in the center of the implant can involve several advantages wherein a uniformly expanding of the implant is among those. Furthermore, with a centralized implantation device, the implant can be controlled and positioned in a better way. The following example may point this out: In the case of a heart valve prosthesis as implant, it can be necessary to align or orientate, respectively, it relative to the commissures of the aortic root during the insertion of the prosthesis (the implant) supported by the implantation device in such a way that the orientation thereof and the orientation of the valve leaflets arranged at the prosthesis are concerted or coordinated, respectively. For this purpose, the physician rotates the implantation device around its longitudinal axis and, with a centrally arranged implantation device, this rotation brings the heart valve prosthesis into a desired position relative to its orientation in its rotational direction, too. If the implantation device is thereby not arranged in the center of the rotational-symmetrically constructed heart valve prosthesis, the heart valve prosthesis experiences a displacement in a radial or lateral direction. This displacement not only complicates achieving the desired orientation in the rotational direction, but also effects an undesired force and stress of circumjacent structures such as of the aortic root, of an already inserted receiving means for receiving and anchoring the prosthesis and the like. Centralizing the implantation device in the center of the implant can advantageously counteract this. The relative relation between the implantation device and the implant can remain unchanged. The occurrence of undesired displacements and forces can advantageously be avoided.

In certain embodiments of the present invention, centralizing the implantation device in the center of the implant or the arrangement thereof in the center of the implant, respectively, can advantageously be used for checking the valve function with an implantation device still being connected to the implant. The valve leaflets can unfold and close for a functional check without being hindered by the centrally arranged implantation device; however, this would not be possible if the implantation device would have been arranged at the edge, relative to a cross-section of the implant or of the valve. A position of the implantation device other than the central position could result in a non-uniform opening and closing of the valve leaflets and complicate a functional check, falsify or distort, respectively, the result thereof or make it impossible. Such a functional check with an implantation device still being connected to the valve is, however, of great importance and of great utility, because a revision or a re-positioning of the valve shall be possible when an unsatisfying position has been determined.

In some embodiments of the present invention, a central position of the implantation device, relative to the cross-section of the implant or of the valve, can also be advantageous in a folded or non-expanded state of the implant, because this position can allow a simplification of folding, crimping or the like of the implant. Thereby, the space requirement can advantageously be reduced, a damage of the implant or sections thereof (such as, in some embodiments, valve leaflets) can advantageously be avoided, etc.

In certain embodiments of the present invention, a central position of the implantation device, relative to the cross-section of the implant and/or of the valve, can furthermore advantageously enable to control the position of the implant in such a way that the implant uniformly contacts the structure into which it shall be inserted at its periphery. Tension or force peaks which can damage the receiving tissue or complicate the insertion process of the implant can thus advantageously be avoided. The risk of damaging the implant (for example, valve leaflets) or injuring tissue can hereby advantageously be diminished.

In some embodiments of the present invention, the implant is being crimped, is crimped and/or is configured to be crimpable onto the implantation device and/or a device for supporting or receiving the implant, and released or configured to be releasable from the latter at the implantation site.

In certain embodiments of the present invention, the implant is intended to be detachably fixed, attached or crimped on a portion or a surface of an implement device, such as a catheter, for being delivered to an implantation site.

In particular embodiments, the implant has a longitudinal axis, or an inner space or inner volume longitudinally extending within the implant, and has a radial direction perpendicular to the longitudinal axis, space or volume.

In some embodiments of the present invention, the implant comprises a first structural element having a first portion and a second structural element having a second portion.

In certain embodiments of the present invention, the implant comprises one or more interconnecting elements arranged between the first and the second structural elements.

In some embodiments of the present invention, the first and/or the second portions of the implant are located less radially as regards the longitudinal axis, the inner space or volume than a third portion of the one or more interconnecting elements.

Further the present invention relates to a method of detachably attaching, fixing, arranging, crimping and/or connecting an implant or a device comprising at least an implant on or with an implantation device as defined in claim 11.

In some embodiments, the method of detachably attaching, fixing, arranging, crimping or connecting an implant on or with an implantation device comprises the optional additional step of crimping or folding the implant such that there remains a first gap between one, more or all of the interconnecting elements and an outer surface of the implantation device.

In certain embodiments of the present invention, the implant may be of an expandable and again foldable or collapsible, respectively, type. Such implants may, for example, be changed in its diameter by means of strings guided around certain portions of the implant that can be tightened or released. The features required to be amendable in diameter are not in the main focus of the present invention. Since they are further explained in great detail in WO 2008/029296 A2 (“Minimally invasive heart valve replacement”, filed on Feb. 15, 2007) to the inventors of the present invention, and also in WO 2009/109348 A1 (“Stent, welcher vom expandierten Zustand kontrolliert erneut im Durchmesser verringerbar ist”, filed on Mar. 2, 2009) also to the inventors of the present invention, for the sake of avoiding repetition it is referred to those documents as regards those features. The respective disclosure is herewith incorporated into the present application by way of reference. The same applies to any material mentioned in either of both applications.

In certain embodiments, “radial” or “radially” may be understood as “lateral” or “laterally”, both indicating that a first structure that is arranged radially or laterally with respect to a second structure is more distant to, e.g., a central axis or a medial element than the second structure is. Consequently, “less radial” means more central or medial.

In some embodiments, the first structural element is a proximal structure, with the second structural element being a distal structure.

In particular embodiments, the interconnecting elements are two or more, in particular three, equidistantly or equi-angularly spaced posts. The posts may be equally spaced from each other. The posts may be located at 120° to one another.

In certain embodiments, one, more or all of the interconnecting elements is or forms a mesh. In some embodiments, the mesh is designed such that it can be changed in its diameter. Preferably, the mesh can be changed in diameter without (at all or significantly) changing its longitudinal extension. That is, the mesh can be prepared not to lengthen or to foreshorten upon changing the implant's diameter.

In some embodiments, the at least one or more interconnecting elements interconnect the first and the second structural elements with each other.

In certain embodiments, the interconnecting element or elements are provided for maintaining a distance between the first and the second structural elements.

In some embodiments, the interconnection of the first and the second structural element can be of a direct or indirect manner.

In certain embodiments, the interconnecting elements are posts arranged at or within the implant such that in at least one state, or in any state, of the implant the posts extend in parallel to the longitudinal axis, the inner space or volume.

In some embodiments, “in parallel to the longitudinal axis” simply means that there is a plane comprising a post at issue and another plane comprising the longitudinal axis, with those planes not intersecting with each other.

A state, as referred to above, may be a fully expanded state of the implant, e.g., after completion of the implantation process. A state may be a fully crimped state of the implant. A state may be the crimped state of the implant upon delivery to the implantation site by means of the implantation device.

In certain embodiments, the implant, in particularly the first structural element and/or the second structural element has at least a fourth portion, and possibly also a fifth portion, and maybe also further portions, located more radially or laterally as regards the longitudinal axis or the inner space/volume than a particular third or any third portion of the one or more interconnecting elements.

This may be the case in particular embodiments in a state in which the diameter or the radial expansion of the inner space is reduced due to external pressure put on the implant, or in all states the implant may take on or actually takes on during normal use of the implant.

In some embodiments, the fourth portion (and maybe also further portions also located more radially or laterally as regards the longitudinal axis or the inner space/volume than a particular third or any third portion of the one or more interconnecting elements) rises above the lateral or radial level of the third portion during the crimping process. In certain embodiments, for example, the first and/or the second structural element is at least temporarily deformed by the crimping process such that the fourth portion “stands up” (i.e., rises) during crimping. It is well possible that the fourth portion looses its prominent position again after expansion of the implant as is the case in some embodiments.

In particular embodiments, the third portion is provided more radially as regards to the inner space or volume than the first and/or the second portion in a state in which the diameter or the radial expansion of the inner space or volume is reduced due to external pressure put or applied, respectively, on the implant.

In certain embodiments, the state in which the diameter or the radial expansion of the inner space is reduced due to external pressure put on the implant is a fully crimped state or a state into which the implant has been crimped or would be crimped upon crimping for being implanted.

In some embodiments, the state in which the diameter or the radial expansion of the inner space is reduced due to external pressure put on the implant is a crimped state of the implant in which the first or the second portions or both portions contact an outer surface of the implantation device.

In certain embodiments, the first structural element and/or the second structural element is/are (a) guiding structure(s) for guiding strings for amending—both increasing and/or decreasing —the diameter of the implant once brought into a part of a body vessel or a part of the patient's heart.

In some embodiments, the implant is designed such that after having been crimped on the implantation device there remains a first gap between one, more or all of the interconnecting elements and an outer surface of the implantation device.

In certain embodiments, the gap or parts thereof are mainly or partly tube-shaped.

In some embodiments, the implant is designed such that after having been crimped on the implantation device there remains a second gap between one, more or all of the interconnecting elements and an inner surface of a sleeve covering the implant.

Again, in certain embodiments, the second gap is tube-shaped—mainly or partly.

In some embodiments, the first gap and/or the second gap is/are intended to accommodate structures like leaflets, commissures or the like, or sections thereof. Its size may be tailored to needs.

In certain embodiments, in a crimped or delivery state of the implant, the width of the first gap and/or of the second gap is at least 2 mm, or at least 3 mm, or at least 5 mm.

In particular embodiments, the implant comprises at least one sleeve. One of the sleeves may cover the implant on its outer surface.

In some embodiments, the method of detachably attaching, fixing, arranging, crimping and/or connecting an implant on or with an implantation device may comprise optionally the covering of the crimped implant with a sleeve, in particular such that there remains a second gap between one, more or all of the interconnecting elements and an inner surface of a sleeve covering the implant.

In certain embodiments, the method of detachably attaching, fixing, arranging, crimping and/or connecting an implant on or with an implantation device may comprise optionally crimping or folding until the final crimping state before implantation is reached. Therefore, wherever it is above referred to crimping of the implant such that there remains a first gap between one, more or all of the interconnecting elements and an outer surface of the implantation device, the final crimping state may be meant.

Along with advantages that are obvious to the skilled one and previous discussed advantages, the embodiments may provide one or more of the following advantages.

Although crimping of implants, in particularly stents, is well-known in the art and probably the most often used method for temporarily fixing an implant on an implantation device, according to the findings of the inventors the implant or structures comprised by the implant are frequently adversely compressed and sometimes even damaged. Those damages have hitherto not been realized neither by the skilled ones nor by the public. The present inventors, however, realized a problem resulting from applying undue pressure on, e.g., the leaflets of a heart valve replacement such as the one described in above mentioned WO 2008/029296 A2. It appears that the damages observed resulted from a pressure applied on the leaflet and the commissures upon crimping between the interconnecting elements or posts and the sleeve, respectively, on the one side, and the crimping surface (outer surface) of the implantation device on the other side.

In some embodiments, the implant design provides for space (the first gap) between the interconnecting elements to allow, e.g., the commissures of above implant of the figures or other structures to be located between the interconnecting elements and the surface of the implantation device without being pressed or even damaged.

Further, in certain embodiments, a design of the implant provides for sufficient space (second gap) for structures such as the leaflets of the implant of WO 2008/029296 A2 between the sleeve (if provided) or the vessel wall during delivery of the implant, and the surface of the relatively hard and inelastic implantation device.

In some embodiments, crushing of leaflets of a valve replacement comprised by the implant may be advantageously avoided.

In certain embodiments, a disruption of collagen fibres within leaflets of a valve replacement of natural origin (bovine, for example) after having been crimped can advantageously be prevented.

In certain embodiments, the means or the apparatus configured for controlling the expansion, folding and/or unfolding may fold or unfold an implant by using at least a tension thread.

In some embodiments, the means for controlling the expansion, folding and/or unfolding includes a shaft having a reception area for receiving the implant.

In certain embodiments, the means for controlling the expansion, folding and/or unfolding and/or the implantation device further includes at least one tensioning device for altering a shape of the foldable and/or unfoldable implant by means of the tension thread.

In some embodiments, the means for controlling the expansion, folding and/or unfolding and/or the implantation device includes a separation device for separating at least one tension thread from the implant and/or for cutting or cutting through the tension thread.

In particular embodiments, the at least one tension thread is a thread. The thread may be similar to a surgical suture thread. The thread may have the shape of a rope, a filament or of a cord. The thread may optionally be designed as a chain having a plurality of engaging chain links.

Whenever the present application refers to a thread or tension thread, there may be meant a plurality of threads or tension threads, for example, two, three, four, five or more threads, whenever a person skilled in the art recognizes the exchangeability of the terms.

In certain embodiments, the shaft of the means for controlling the expansion, folding and/or unfolding and/or of the implantation device is rigid. In some embodiments, the shaft is flexible in one or more directions (i.e., in a′longitudinal direction or in a direction of the width of the shaft, respectively, in both directions or in other directions). In certain embodiments, the shaft is elongatable. In some embodiments, the shaft is stiff.

In some embodiments, during its implanted implantation state and/or in its implanted state, the implant is able to be penetrated by fluids or is permeable for fluids, respectively, in its longitudinal direction. The terms “permeable” or “able to be penetrated” hereby refer to the ability of the implant to be penetrated or flown through by fluids.

In certain embodiments, the implant is—at least transiently or temporarily—mounted or loosely arranged on or at the reception area of the means for controlling the expansion, folding and/or unfolding or of the implantation device at the moment of unfolding or folding.

In some embodiments, the implant is arranged on or at the reception area or is interconnected with the reception area only by tension threads.

In certain embodiments, the tensioning device includes at least one pulling device. The pulling device is arranged and/or provided in such a way that it can indirectly or directly apply a tension on the implant for altering the shape of the implant by means of the tension thread.

Alternatively or additionally, in some embodiments, the pulling device is arranged and/or provided in such a way that it can reduce a tension applied on the implant by means of the tension thread.

In certain embodiments, the pulling device is arranged and/or provided such that it can interact with the tension thread in order to transfer force or tension.

In some embodiments, the pulling device and the tension thread are intricate with each other at at least one site.

In certain embodiments, the term “intricate” may be used to indicate that the tension thread is movable in at least one direction of space or in two directions of space relative to the pulling device.

According to some embodiments of the invention, the term “movable” may be understood as “slidable”.

According to certain embodiments of the present invention, the term “intricate” may mean that the tension thread is movably arranged relative to the pulling device like a first link of a chain is movably arranged relative to an adjacent second link of this chain to which the first link is usually connected in a chain.

In some embodiments, the term “intricate” may indicate that the tension thread is simply crossed once with or wrapped around the pulling device or sections thereof.

In some embodiments, the transfer (or the transmittal, respectively) of force or tension between the pulling device and the tension thread is achieved by a non-form closure connection.

In certain embodiments, the transfer of force or tension between the pulling device and the tension thread is achieved by a frictional connection.

In some embodiments, the pulling device is embodied as at least one pulling thread or consists of at least one pulling thread.

In certain embodiments, the tension thread and/or the pulling thread includes or constitutes at least one bundle or a plurality of threads or thread elements or consists thereof.

In some embodiments, the separation device includes at least one cutting device for cutting (or cutting through) the tension thread or consists thereof.

In certain embodiments, the separation device is not a wire or a thread (or a multitude thereof, respectively).

In some embodiments, the separation device is not embodied as a lock wire or lock thread that is withdrawn from the apparatus so as to allow for removing tension threads from the apparatus after final placement of the implant.

In certain embodiments, the separation device does not comprise hooks and/or does not comprise rings for guiding or limiting tension strings or threads.

In some embodiments, the separation device is embodied and/or intended to stay with the apparatus even after termination of the implantation of the implant.

In certain embodiments, the separation device may not be separated from the apparatus except for cleaning or the like.

In some embodiments, the separation device is embodied such that it is intended to be used only within the patient's body.

In certain embodiments, the separation device is not intended to be used for separating the tension threads from implant from outside the patient's body.

In some embodiments, the separation device can not be used to separate the tension strings without the presence and/or the support of the apparatus.

In certain embodiments, the apparatus includes at least one sleeve. The sleeve can preferably be made tube-like (that is, it can have a hollow inside), like a hollow cylinder, like a ring or the like. The sleeve can be designed symmetrically or asymmetrically, both relative to its opening direction and in another direction, particularly in a direction or plane perpendicular to the opening direction or the fluid passage direction, as well.

In some embodiments, the separation device is designed as a—preferably integral—part of a sleeve aperture in one wall of the sleeve of the apparatus. The sleeve aperture may connect an exterior of the sleeve with an interior of the sleeve. The sleeve aperture may in particular be designed as a passage opening or a through opening. It can thus be as thick as the wall of the sleeve is in a radial direction of the apparatus.

In certain embodiments, the sleeve aperture includes at least one first recess. At least one tension thread can be led or guided through—or by means of—this first recess.

In some embodiments the first recess includes a first portion or first area which includes a cutting device for cutting through the tension thread.

In certain embodiments, the cutting device is or comprises a cutting edge. In some embodiments, the cutting device is attached to the sleeve. In certain embodiments, the cutting device is integrally formed with the sleeve.

In some embodiments, the first recess includes a second portion or second area which does not include a cutting device.

In certain embodiments, the sleeve aperture includes at least one second recess in which at least one tension thread can be led or guided, preferably in the same way as with the first recess.

In some embodiments, the first recess and the second recess can be separated from each other by means of a bar in such a way that at least two tension threads can be led or guided in the recesses while being spaced apart from another.

In some embodiments, providing a distance between the two recesses can allow the leading of one or more tension threads having been distributed to the two recesses without touching each other in the area of the recesses. Thus, the leading of several tension threads through one sleeve aperture is advantageously possible without the tension threads constricting or hindering themselves. Additionally, the separated leading of tension threads being favored by providing several recesses advantageously allows for a separate treatment or use of each single tension thread: tension threads being led through a first recess can thus advantageously be differently use or treated tension threads being led through a second recess.

In certain embodiments, the bar is part of the sleeve. Hence, the bar is part of the sleeve wall and/or integrally formed therewith.

According to the invention, both recesses given above can also be referred to as niches, as extensions, as indentations, as furcations, as notches and so on (this can also apply for third, fourth and several more recesses). All of these terms have in common that the recesses, niches or the like branch off a common, particularly wide, area of the sleeve aperture or are connected therewith.

In certain embodiments at least the first recess (or any other recess) extends in one dimension of the apparatus (preferably in a longitudinal extension of the apparatus) differently than at least the second recess does in the same dimension of the apparatus.

In some embodiments, the shaft of the apparatus is permeable or has a passage for fluids in its interior in at least some sections of its longitudinal direction.

In certain embodiments, the shaft has a wall.

In some embodiments, the shaft includes at least one shaft aperture. The at least one shaft aperture is preferably rather arranged on a lateral area of the shaft than on the front side thereof.

In certain embodiments, the shaft of the apparatus includes a plurality of shaft apertures having been uniformly or non-uniformly distributed along one or more circumferences and/or along the longitudinal extension of the shaft.

In some embodiments, tension threads for folding and/or unfolding the implant can enter and/or leave the apparatus through the shaft aperture. During use of the apparatus, the sleeve is arranged in an interior or in an exterior of the shaft such that tension threads can (preferably unrestrictedly and/or directly) be led from the exterior of the apparatus into an interior of the apparatus.

In certain embodiments, the tension threads can be led unrestrictedly and/or directly, that means without having to be bent or redirected, from an exterior of the apparatus into an interior of the apparatus, particularly into an interior of the sleeve and/or into an interior of the shaft.

In some embodiments, the sleeve is preferably arranged in a shiftable manner.

In certain embodiments, the sleeve can preferably surround the shaft in such a way that the shaft is located inside the sleeve and the sleeve is at an outside of the shaft. The at least one tension thread can thus pass from an exterior of the sleeve through the shaft aperture into an interior of the shaft (or vice versa).

Alternatively, the sleeve can in some embodiments be located inside of the shaft such that the shaft is surrounding the sleeve. The at least one tension thread can thus pass from an exterior of the shaft through the shaft aperture and through the sleeve aperture into the interior of the sleeve (or vice versa).

In certain embodiments, the apparatus includes a pre-tensioning device which is arranged for exerting tension on the sleeve in at least one state of use.

In some embodiments, the pre-tensioning device exerts a tension on the sleeve substantially or exclusively in a longitudinal direction of the shaft.

In certain embodiments, the pre-tensioning device exerts a tension on the sleeve so as to twist the sleeve relative to the shaft.

In some embodiments of the invention, the pre-tensioning device is embodied as a spring, particularly as a coil spring, and/or is embodied from any suitable—preferably from elastic or flexible—material such as rubber.

In certain embodiments, the pre-tensioning device is arranged for build up or maintaining the pre-tension in a pushing manner.

In some embodiments, the pre-tensioning device is arranged for build up or maintaining the pre-tension in a pulling manner.

In certain embodiments, the pre-tensioning device is arranged for maintaining the separation device and/or the cutting device and/or the sleeve in a non-separating position in which no tension thread is separated from the implant and in which no tension thread is cut through.

In some embodiments, the apparatus includes a device with which the separation device and/or the cutting device and/or the sleeve is transferred into a separating position in which at least one tension thread is separated from the implant or in which at least one tension thread is cut (through).

In certain embodiments, said device which enables a transfer or transition from the non-separating position into the separating position is embodied as a pulling device as, e.g., a thread or the like. In another embodiment, said device is embodied as a pushing or twisting device.

In some embodiments, said device which enables a transfer or transition from the non-separating position into the separating position includes at least one pulling thread or pushing means or twisting means which is led from its branching off at the sleeve to an exterior of the apparatus. The end of the thread or pushing means or twisting means which is distal to or far from the sleeve can be connected to a grasping device suited for grasping the thread for the purpose of pulling or pushing or twisting it. At an exterior thereof, the apparatus can include—but does not have to include—a snapping device for releasably receiving the grasping device. The grasping device can rest on the snapping device until its use.

In some embodiments, said device is arranged such that it can only be transferred from a non-separating position into the separating position by overcoming the effect of the pre-tensioning device.

In certain embodiments, at least one recess is designed and provided in the sleeve such that at least three different openings or outlets can be formed by superposing the shaft aperture and the sleeve aperture (e.g. by shifting or moving the sleeve inside the shaft or the shaft inside the sleeve).

Whenever it is herein referred to “at least three different openings”, these openings can each have a different geometrical shape, according to some embodiments of the present invention. In other words, the openings can differ in their design.

In certain embodiments of the present invention, the “three different openings” can differ in the size of their respective area.

In some embodiments of the present invention, such an opening is defined as the open passage between an exterior of the apparatus or of the shaft of the apparatus and an interior of the apparatus or of the shaft.

In certain embodiments of the present invention, such an opening is an area in which a passage both through the shaft aperture (i.e. an opening in the wall of the shaft) and through the sleeve aperture (i.e. an opening in the wall of the sleeve) is open in the sense of a passage opening.

In some embodiments of the present invention, the “three different openings” can differ in their function.

In certain embodiments a first opening can be large enough to allow introducing one or several tension threads from an exterior of the apparatus into an interior of the apparatus, e.g., both through a wide area of the sleeve aperture and a shaft aperture adjoining or neighboring the latter.

In some embodiments of the present invention, a second opening can have the function (and the shape required thereto) not to be large enough for allowing (preferably easy) introduction of a tension thread through a wide area of the sleeve aperture. The wide area of the sleeve aperture can thus, for example, be covered by the shaft wall. The second opening can have the function to lead at least two tension threads through at least two recesses in such a way that the tension threads cannot touch each other and/or cannot get in contact with each other in the recesses and/or cannot entangle themselves.

In certain embodiments of the present invention, a second opening can have the function of not bringing a separation device or a cutting device in contact with one or all of the tension threads or of inhibiting such a contact.

In some embodiments of the invention, the separation device or the cutting device can be covered at the second opening by a portion of the wall such that the tension threads cannot get in contact with the separation device or the cutting device.

In certain embodiments of the invention, the openings can each comprise a range of geometrical shapes. Therefore, the openings need not to have an unchangeable shape or size as long as the respective function (and optionally this function alone) is possible in the respective range of the geometrical shape. However, each opening can be variable within the limits given by the corresponding range.

In some embodiments of the invention, the apparatus is designed for folding and/or unfolding an implant in form of a stent or a cardiac valve assembly.

Furthermore, the present invention may refer to a method of folding or unfolding an implant or to a method of detachably attaching an implant comprising such a step. Such a method of folding or unfolding or step may, according to the invention, comprises the use of an apparatus or of a set according to the present invention.

In certain embodiments the method or the method step may comprise the altering the tension that is exerted on an implant by using at least one tension thread. The tension may be preferably controlled by altering a length of the pulling device branching off the interior of the shaft.

In some embodiments the method or the method step may further comprise cutting or cutting through, respectively, at least one tension thread by inducing, enabling or allowing a relative movement between the shaft and the sleeve.

The advantages achievable by the apparatus as described above can also be achieved by the set according to the invention and/or by an implantation device.

Among the advantages achievable according to the present invention is the possibility of independently actuating tension threads. This is due to the self balancing design. Thus, it is possible to specifically fold and/or unfold implants having a plurality of tension threads. Parts or sections of the implant can thus be folded or unfolded though other parts or sections of the implant have already been completely folded or unfolded. This can i.a. be reasonable when an unfolded implant and the implantation site do not completely match in their dimensions, or if the implant does, e.g., not have a uniform shape over its entire length.

Furthermore, the possibility of simply connecting tension threads to the apparatus, for example, by means of and trough the wide area of the sleeve aperture in some embodiments of the invention, is one of the advantages achievable according to the present invention.

Another advantage is that the tension threads can in some embodiments of the present invention be led or guided separately from each other. A mutual interference of the tension threads can thus be avoided.

In some embodiments of the present invention, it is advantageously possible to separate at least one tension thread from the implant. The thread can particularly be cut through by means of a cutting device.

Another advantage may arise from the fact that, in some embodiments, only one tension thread (or two or more threads) can specifically be separated or detached or cut through, while other tension threads will not be separated, detached or cut through. Particularly for a sloop-like or loop-like design of the tension threads, it is thus possible to cut through a portion of the tension thread instead of the sloop as a whole. In that way, the whole material that had constitute the sloop or loop can be retracted into the shaft by pulling the non-cut parts or side of the sloop of the tension thread(s). In other words, the tension threads not cut through can be used for separating or detaching all tension threads from the implant by simply pulling the tension thread. This can advantageously be useful i.a. after an implantation.

In some embodiments, the implant comprises at least one supporting means which is suited for supporting the implant at or on an implantation site.

In certain embodiments, both the supporting means and the implant are expandable from a respective first diameter to a respective second diameter and/or are collapsible from the second diameter to the first diameter.

In some embodiments, the supporting means comprises bars which are connected to each other by means of connecting sections.

In certain embodiments, the supporting means comprises at least one post for connecting the supporting means with at least one other structure of the implant.

In some embodiments, at least two of the connecting sections differ in at least one material characteristic, for example in the thickness of the respective connecting sections, in the selection of their manufacturing material, i.e. chemically or in a combination of a different thickness in an arbitrary direction and of a different material selection.

In certain of the embodiments, the material characteristic refers to a thickness of at least one section of the connecting sections in a longitudinal direction of the implant and/or in a direction present at a right angle thereto (lateral direction). In an implant which is perfused by bodily fluids after its implantation, the longitudinal direction of the implant can correspond to the direction of the (main) perfusion. The lateral direction of the implant can be a direction in which a (main) expansion of the supporting means takes place (e.g., at the implantation site in the patient's body or before the implantation in a laboratory without any external application of force to the supporting means).

In some of the embodiments of the implant, a first connecting section having the smallest distance to a post has a first thickness d1. Thereby, this thickness is the smallest thickness of all thicknesses of the connecting sections.

In certain of the embodiments of the implant, a second connecting section has a second thickness d2. Thickness d2 is larger than thickness d1. In some embodiments, the second connecting section has the next smaller distance to the post. It is thus adjacent to the first connecting section and has a larger distance to the considered post than the first connecting section.

In some of the embodiments of the implant, a third connecting section has a third thickness d3. Thickness d3 is larger than thickness d2. It is thus adjacent to the second connecting section; however, it is not adjacent to the first connecting section and has a larger distance to the considered post than the first connecting section and the second connecting section.

In certain of the embodiments of the implant, a post is understood as a section of the supporting means which substantially is not curved, i.e., extends linearly.

In some embodiments, a connecting section is understood as a section of the connecting means which connects two or more bars with each other and which is more curved than at least one of the bars.

In certain embodiments, a connecting section is understood as a section of the supporting means being a point of curvature in the sense of a curve progression. Thereby, the point of curvature of the connecting section is the point which is ever located most next to an end of the implant—with respect to the longitudinal direction thereof.

In some embodiments, the implant is designed or embodied with cardiac valves—in particular artificial ones or ones which have been manufactured from animal tissue.

In certain embodiments, bars comprised by the supporting means which connect a rod or post with the adjacent connecting sections are shorter than other bars. The shorter bars contribute to forming a slit that reaches from an end of the supporting means to the adjacent end of the post. The slit has a length of L2 (from its open end to its closed end).

In some embodiments, from the opposite end of the slit to the adjacent end of string outlet or aperture 10 a distance having a length L3 is provided. Between the closed end of the slit and the centre of string outlet or aperture a distance having a length L4 is provided.

In certain embodiments, the open end of the slit may be spaced from the centre of the outlet or aperture by the sum of L2 and L4.

In particular embodiments, L1 is between 2.5 and 3.5 times as long as L2, preferably 3 times as long. L1 is the length of the supporting means in a distal-proximal direction thereof.

In some embodiments, L2 is 2 times (or between 1.5 and 2.5 times) the length of L4.

In certain embodiments, L2 is 3 times (or between 2.5 and 3.5 times) the length of L4.

Regarding its basic design, the implant can be constructed in some embodiments as is, for example, described in DE 10 2008 013 948 A1 by the applicant of the present invention. By way of reference, the content thereof is also subject-matter of the present invention. This particularly applies for the materials and (part) geometries given therein.

In certain embodiments, the implant can be partly self-expanding, partly by the use of an expanding means.

In some embodiments, the implant can exclusively be non-self-expanding. By using the implant according to some embodiments of the invention, an expansion thereof is possible without distorting or warping, respectively, or undulating or waving, respectively, the supporting structure. In some embodiments, this can primarily enable a multiple, however, at least a twofold, re-expansion following a happened reduction of the cross-section. The desired expansion behavior of the supporting means is maintained in such a case, too. A distortion or warping, respectively, or an undulation or waving, respectively, does not take place in such a case, too. The latter advantageously allows for a precise positioning of the implant. It can further ensure the more accurate residing of the supporting means and, thus, of the implant against the tissue of the implantation site.

Further, the likelihood of any undue or adverse stress concentration within the solid parts of the implant can advantageously be avoided or minimized.

In some embodiments, the in particular medical, implant comprises at least one foldable or collapsible or crimpable and unfoldable or expandable structure (therefore also referred to as structures) on or around or over a portion or outer surface of a catheter or of a catheter tip or of any other delivery implement or device or part thereof is proposed.

In particular embodiments, a method or method step for crimping may comprise the feature that no pressure or only a permissible, for example predetermined pressure, is exerted on the structure during and/or after crimping of the implant beyond a predetermined pressure.

In some embodiments, the set according to the invention and/or the implantation device or a device for receiving and/or supporting the implant may comprise at least one crimping device for crimping of an implant comprising at least one foldable and unfoldable structure on or around or over a portion or outer surface of a delivery or implantation device with a predetermined pressure exerted on the structure.

In certain embodiments, the predetermined pressure exerted does not exceed a predetermined pressure.

In some embodiments, no pressure is exerted on an implant or on the least one foldable and unfoldable structure during and/or after crimping of the implant beyond a predetermined pressure.

In particular embodiments in the context of the present invention, the term “crimping an implant” may mean the crimping result achieved after termination of the entire crimping process of the medical implant.

In the context of the present invention the term “crimping an implant” may mean that the implant crimped is to be understood as prepared on a delivery or implantation device or device to be inserted or implanted.

In certain embodiments, in the context of the present invention the term “crimping a medical implant” may mean that additional or further crimping it not necessary or not contemplated or not required before implanting of the implant.

In some embodiments, in the context of the present invention the term “predetermined pressure” may refer to a pressure value that has been determined and/or considered and/or selected by the person responsible for the crimping process or carrying out the same before or during the crimping process takes place.

In certain embodiments in the context of the present invention the term “predetermined pressure” may refer to a pressure value adjusted at a crimping device. The value can preferably be adjusted as a maximum pressure value exerted on certain structures of the implant, for example, heart valve replacement leaflets or commissures thereof.

In some embodiments, in the context of the present invention the term pressure exerted “during and/or after crimping of the implant” may refer to pressure exerted by means of the crimping itself.

In particular embodiments of the method of detachably attaching an implant and/or of releasing an implant according to the invention, the method may comprise the step of measuring the pressure acting on or in the structure, or between the structure and other parts of the implant, or between the structure and the delivery device (in particular, the circumferential surface or a section thereof of the delivery device), and the step of terminating the crimping procedure once the pressure measured has reached the predetermined pressure or exceeds the predetermined pressure. In some of these embodiments, the methods comprises placing a pressure or force sensor in direct contact with the structure.

In certain embodiments, in the context of the present invention the term “predetermined pressure” may refer to a pressure that exclusively results from the crimping steps as such. In those embodiments, pressure exerted on the structures at issue stemming or originating from other pressure sources than by the crimping steps is not referred to as the predetermined pressure. Such other pressure comprises the atmospheric pressure, water or fluid pressure, and the like. In certain embodiments, such additional pressure does not contribute to the determined pressure or the level thereof.

In some embodiments a predetermined pressure may be understood as a predetermined force, strain, stress and the like as well. Hence, in those embodiments, the terms pressure, force, strain, stress and the like may be understood as interchangeable.

In certain embodiments, the predetermined pressure is to be understood as a maximally allowable pressure that is measured or may be measured between the structure of the implant and a circumferential surface or an envelope of the delivery device, or equals the such measured pressure.

In particular embodiments, the structure is not the proximal or the distal ring of the implant.

In some embodiments, the structure on the implant is not intended to contribute to the temporary fixation of the implant on the delivery implement/device.

In certain embodiments, the implant comprises one or more interconnecting elements, and the pressure exerted or applying on the structure is determined between the interconnecting elements and the outer surface or the portion of the catheter.

In some embodiments, the interconnecting elements may be embodied as posts interconnecting a proximal and a distal ring or support structure.

In certain embodiments, the interconnecting elements may be embodied as radially (as regards a longitudinal axis of the implant or of the delivery device) expandable or shiftable structures, of the implant, wherein they are expanded or shifted or moved away from the upon expansion of implant.

In some embodiments, the interconnecting elements may be embodied as one or more posts.

In certain embodiments, the interconnecting elements may be embodied as structures provided for maintaining a distance between a distal ring and a proximal ring of the implant.

In some embodiments, the predetermined pressure is 0 N per square millimetre (0 N/mm2) or 1 N/mm2 or 2 N/mm2 or 3 N/mm2 or 5 N/mm2. If the predetermined pressure is 0 N/mm2 or about 0 N/mm2, the method may be called a “zero pressure crimping” method.

In certain embodiments, the predetermined pressure is 5 N per square millimetre (5 N/mm2) or 8 N/mm2 or 10 N/mm2 or 15 N/mm2 or 20 N/mm2 or 25 N/mm2 or 30 N/mm2 or any value in between.

In some embodiments, the method of crimping or folding and/or unfolding is carried out manually by the aid of non-electric tools.

In certain embodiments, the method of crimping is carried out by the aid of automatic tools. Such tools can be electric, pneumatic, hydraulic tools and the like.

In some embodiments, the crimping device comprises a pressure limiting means for limiting the pressure that is exerted or exertable on the implant and/or on the structure during and/or after crimping of the implant.

In certain embodiments, the pressure (or force) exerted or exertable on the structure may be known once the pressure (or force) exerted on the implant comprising the structure is known. For example, it might be known—e. g. from known relationships between a first and a second pressure as defined in the following—that zero pressure (being one example of a first pressure) is applied on the structure if less than a certain pressure (second pressure) is exerted on the implant during crimping. In those embodiments, it may be sufficient to limit the (second) pressure applied to the implant. As may be known in that case from earlier experiments or from a look-up-table, the (first) pressure applied to the structures or acting on the structures in question will then not be higher than a predetermined pressure or a pressure considered to be a maximum pressure that is allowed to apply to the structure.

In some embodiments, the crimping device comprises a pressure sensor (or is functionally linked with it) that reflects the pressure or force exerted on the structure at issue (e.g., the leaflets comprised by the implant) during crimping. Preferably, the pressure sensor is placed, for example, between the structure at issue (such as the leaflets of the implant) and a neighbouring structure (such as an outer surface or other part of the implantation device used). In certain embodiments, such a pressure sensor or any other suitable sensor is provided with the implantation device. In some embodiments, the pressure sensor or any other suitable sensor is located within a lumen of the implantation device or on an outer surface thereof.

In certain embodiments, the crimping device is intended and/or configured for crimping by means of a predetermined pressure exerted on the structure during and/or after crimping of the implant.

In some embodiments, the crimping device comprises a controller for limiting or controlling the pressure exerted on the structure of the implant.

In certain embodiments, the crimping device comprises an adjusting means for adjusting the pressure exerted upon crimping. The adjusting means may be connected to the controller.

In some embodiments, the crimping device is intended and/or configured for crimping medical implants, in particular for crimping only medical implants.

In certain embodiments, the crimping device comprises one or more pressure sensors that output a signal indicating the pressure applied on the structures at issue during crimping.

In some embodiments a device for receiving, supporting and/or folding or unfolding the implant is intended to be attached to or interconnected with at least a medical implant and intended to be attached to or interconnected with at least an implantation device and/or a device supporting or receiving the implant.

In certain embodiments, the device can be temporarily or permanently or detachably attachable to or interconnectable with the medical implant.

In some embodiments, the device can be temporarily or permanently or detachably attachable to or interconnectable or connected, respectively, with the implantation device.

In certain embodiments, the device can be mainly or partly tube-shaped. As such, the device can have a circular or oval cross-section. However, the device may also have any other cross-section apt for establishing a connection between the device and the implantation device.

In some embodiments, as regards the implant, the device does not have to be designed in a particular way as long as the implant can be temporarily or permanently or detachably fixed at or onto the device.

In certain embodiments, the device detachably comprises the implant.

In particular embodiments, the implant can be of any type that is known to a person skilled in the art for supporting or carrying out functions of a patient's body. Examples include implants such as heart valves, substitutes or replacement of heart valves, stents for holding vessels or other body tubes open, and the like.

In some embodiments, the implant is foldable and/or unfoldable and comprises first folding and/or unfolding means adapted and/or intended or configured for folding and/or unfolding the implant.

In certain embodiments, the implant is intended to be attached to or interconnected with the device by means of crimping. That is, the device is intended to have the implant crimped thereon, or the implant has already been crimped onto the device.

In some embodiments, the first folding and/or unfolding means are guided around certain portions of the implant that can be tightened or released.

In certain embodiments, the first folding and/or unfolding means can be arranged at or at least in connection with the implant such that it is or they are, respectively, operatively connected with the implant. The first folding and/or unfolding means can be arranged such that they can contribute to or effect the folding and/or unfolding of the implant which is attached to the device. The folding and/or unfolding of the implant by use of the first folding and/or unfolding means can be effected when a force, a tension or stress or strain is applied or put, onto the first folding and/or unfolding means or rather released from the first folding and/or unfolding means. Such a tension, stress or strain can, for example, be induced or generated by an actuating device (e.g., a pulling device) which can be operated by a user.

In some embodiments, it can be intended to use at least the first folding and/or unfolding means of the implant to establish a connection such as a form closure connection between the device and the implantation device.

In certain embodiments, the first folding and/or unfolding means of the implant can pass through an inner space of the device.

In some embodiments, the inner space is an opening that extends along the whole or entire length of the device, i.e. from a distal end to a proximal end thereof. In other embodiments, the inner space is arranged in a longitudinal direction of the device and extends at least from a front end opening of the device (be it the proximal or the distal end of the device) to a second opening which is an outlet of the first folding and/or unfolding means.

In certain embodiments, the first folding and/or unfolding means of the implant can be arranged such that they leave the device through at least one opening of the device. Such an opening may be provided at one end of the device. However, the first folding and/or unfolding means can leave the device at any other suitable position. The first folding and/or unfolding means can leave the device all through the same opening, however, some of the first folding and/or folding means can also leave the device through different openings.

In some embodiments, the first folding and/or unfolding means can comprise one or more tension threads or threads or strings or can consist thereof.

In certain embodiments, the device comprises attaching or interconnecting means. Such attaching or interconnecting means are intended and provided for attaching or interconnecting the device to an implantation device. The attaching or interconnecting means can assist or support the attachment or interconnection of the device with the implantation device.

In some embodiments, the attaching or interconnecting means are arranged at or within the device. Examples include lugs or noses or the like, but also recesses or notches or the like which are arranged in an inner space of the device in such a way that they favour the attachment or interconnection of the device with the implantation device. However, the device does not have to comprise particularly formed geometrical shapes.

In particular embodiments, in order to establish a preferably tight or firm connection, the device can comprise male faces or terminals and the implantation device can comprise female faces or terminals or vice versa. As such, the connection between the device and the implantation device can resemble or be a plug-in connection.

In certain embodiments, the device is a catheter tip. During preparation of implanting the implant attached to the device by use of the implantation device, the device, the catheter tip or the like can be attached to or interconnected with the implantation device in situ, for example, in the operating room or theatre, by, for example, merely slipping or snapping on the catheter tip onto the implantation device.

In some embodiments, the implantation device according to the present invention is suited and/or configured or prepared for receiving at least one such device.

In certain embodiments, the implantation device comprises at least one device.

In some embodiments, the implantation device comprises attaching or interconnecting means for being attached to or interconnected with the device. Such attaching or interconnecting means can include lugs or noses or the like, but also recesses or notches or the like. The interconnecting means can be arranged in an inner space of the implantation device or at an outer surface or any other part thereof. The implantation device may have any particularly formed geometrical shapes. The attaching or interconnecting means of the implantation device can form complements or counter pieces, respectively, to the attaching or interconnecting means of the device.

In certain embodiments of the invention, the implantation device comprises second folding and/or unfolding means.

In some embodiments, these second folding and/or unfolding means can contribute to or effect an interconnection or attachment of the implant to the device.

In certain embodiments, the second folding and/or unfolding means is interconnected with or attached to the first folding and/or unfolding means of the implant. The second folding and/or unfolding means can be embodied as tension threads, threads or strings or the like.

In some embodiments, the second folding and/or unfolding means is made of wire (or comprises a wire). In other embodiments according to the invention, the second folding and/or unfolding means is not made of wire (nor comprises it one).

In certain embodiments, the second folding and/or unfolding means is operatively connected to the first folding and/or unfolding means of the implant.

In particular embodiments, the second folding and/or unfolding means is operatively connected to the first folding and/or unfolding means of the implant to remain connected until the implantation device is withdrawn from the patient's body after completion of the implantation of the implant. That is, in these embodiments, the implant is released from the device and/or from the implantation device, by disconnecting the device from the implant (or by releasing the implant from the device) at a site that is different to a connection site where the first and the second folding and/or unfolding means had been connected to each other. In these embodiments, the implantation device may comprise a separating means to separate or to release (e.g., to cut or to disconnect) the implant from the first and/or the second folding and/or unfolding means at a site different to the site where the first and the second folding and/or unfolding means had been connected with each other.

In some embodiments, both the first and the second folding and/or unfolding means are intended to remain with the implantation device after release of the implant from the implantation device.

In certain embodiments, different folding and/or unfolding means are differently colour coded, or they have matching connectors of different shape, or they have different lengths or a combination of such features to avoid a wrong and possibly adverse connection.

In some embodiments, the second folding and/or unfolding means contributes to folding and/or unfolding the implant by means of the first folding and/or unfolding means in that they can transmit a force such as a tension or stress from an actuating device operated by a user to the implant. Usually, such an actuating device is arranged at a proximal end of the implantation device as regards a user, such as, for example a tool holder or a handle, wherein the implant is arranged at the distal end of the implantation device as regards the user.

In certain embodiments, the second folding and/or unfolding means are knotted or interloped with the first folding and/or unfolding means. In other certain embodiments, hook and eye connections are used to interconnect the first and the second folding and/or unfolding means. However, the design or construction of the connection between the first and the second folding and/or unfolding means is not restricted to a particular design. As long as the intended connection between the first and the second folding and/or unfolding means is achieved, any design or construction apt for this purpose is contemplated.

The method of attaching or interconnecting according to the invention serves for loading or providing a delivery implement with an implant before implantation, wherein the method comprises attaching or fixing a device according to the invention comprising an implant onto a delivery implement.

In certain embodiments, the device comprises at least an implant or is composed at least of an implant.

In some embodiments of the method, the implant is released from the device and/or from the implantation device by disconnecting the device at a site that is different from a connection site at which the first and the second folding and/or unfolding means had been connected to each other (before implantation). In some of these embodiments, appropriate means for separating the implant from the device or from the implantation device (i.e. by cutting of strings) may be used.

In certain embodiments, the attachment or fixation of the device to or onto the delivery implement such as an implantation device, in particular a catheter, can be performed at any desired or required point of time. In some embodiments, the device is attached or fixed to the delivery implement in the operation room or theatre or a the bedside.

By using the device, the present invention provides a simple option for attaching or interconnecting an implant to an implantation device at any desired or required point of time, in particular in situ in the operating room just before implanting the implant.

As medical implants can also partly or entirely consist of living tissue, such as for example, pig heart valves, it may be recommended to keep the living tissue in fluid environment during storage or transport. However, at least due to its mechanical structure, the implantation device as a whole should not be stored or transported under wet conditions.

With the described device, it is advantageously possible to store and/or transport the implant and the implantation device separate from each other in best suitable environments.

In some. embodiments, it is possible to assemble the implant and the implantation device for the purpose of implanting in a relative short time and in an uncomplicated manner. For example, in certain embodiments of the invention, a cumbersome assembling of strings and implant right before implantation, e.g., at the bedside, can advantageously be avoided.

In this way, it is advantageously possible to store and/or transport the implantation device in a, for example, dry environment suitable for the sensitive mechanical structure of the implantation device; and to store and/or transport the implant under wet or humid conditions in order to keep its biological tissue in a humid condition. Thus, possible damages of the mechanical structure of the implantation device can advantageously be avoided. The biological tissue does not dry out.

In certain embodiments of the present invention, the device can be designed or constructed such that it is not susceptible for being damaged or destroyed by fluids such as liquids surrounding the implant. As such, it is advantageously also possible to interconnect the device and the implant before storage or transportation. In particular, due to the separation of implantation device and device (tip of the implantation device, for example), both the implantation device and the device can be produced from different materials, in different processes and the like. Each can thus be manufactured to its best, independently of the need of the other part.

Due to the attaching or interconnecting means of the device, it is advantageously possible in certain embodiments to establish or achieve a simple and uncomplicated connection between the device and the implantation device.

In some embodiments, due to simply establishing a connecting between the first folding and/or unfolding means of the implant and the second folding and/or unfolding means of the implantation device, it is advantageously simply and in an uncomplicated manner possible to transfer the required force for folding and/or unfolding the implant from an actuating device of the user to the implant.

In some embodiments, the device for receiving and/or supporting the implant comprises a portion intended for folding and/or unfolding the implant.

The device can be temporarily or permanently or detachably attachable to or interconnectable with the medical implant. The device can be temporarily or permanently or detachably attachable to or interconnectable or connected, respectively, with the implantation device. The implantation device is intended for implanting the implant.

In certain embodiments, the portion intended for folding or unfolding the implant is arranged rotatably, in particular around a longitudinal axis of the device or of the implantation device.

According to the invention, the rotatability can relate or be relative, respectively, to the surroundings, an exterior, an outer layer, or the like of the device.

In some embodiments, the portion intended for folding or unfolding the implant can be supported within the device by means of a bearing, e. g., a pivot bearing.

In certain embodiments, the portion can be provided in one single component with the first portion of the means for attaching or interconnecting described further below or can be provided in force connection in any other way such that both portions are able to rotate only commonly.

In some embodiments, the portion for folding and/or unfolding the implant can be cylindrical or a rotationally symmetrical portion or comprise such a portion.

In certain embodiments, the portion for folding and/or unfolding the implant may have openings intended for guiding strings or threads therethrough.

In some embodiments, the portion intended for folding or unfolding the implant can consist of or comprise another material than a thread or string, respectively, material.

In certain embodiments, the portion for folding and/or unfolding the implant can have another form than a thread or string, respectively, form.

In certain embodiments, the portion can be provided and intended for winding a thread or a string thereon, the thread or string being intended for folding and/or unfolding the implant.

In particular embodiments, the portion intended for folding or unfolding the implant can be detachably interconnected with the device.

In some embodiments, the portion intended for folding or unfolding the implant can be provided and/or intended not to be separated or released from the device by cutting.

In certain embodiments, the portion intended for folding or unfolding the implant may not contact the implant in the state of use of the device.

In some embodiments, the portion intended for folding or unfolding the implant is completely separated from the implant by means of an outer component or layer of the device in the state of use of the device in some embodiments.

In certain embodiments, the portion is interconnected with a portion of the means for folding and/or unfolding the implant. This connection can be an interlooping connection, a screwing connection, a sticking connection, or the like.

In some embodiments, the portion comprises a guiding structure.

In certain embodiments, the guiding structure can be provided at an outer surface of the portion.

In some embodiments, the guiding structure can comprise or consist of one or more channels or grooves, respectively, or recesses that are intended for winding the means for folding and/or unfolding the implant, e. g., in form of one or more threads or strings, respectively.

In certain embodiments, the guiding structure can comprise or consist of one or more fins or noses or lugs, respectively, that are intended for winding the means for folding and/or unfolding the implant, e. g., in form of one or more threads or strings, respectively.

In particular embodiments, the device can further comprise a displacing means or an advancing means (or mechanism) by which the portion for folding and/or unfolding the implant can be moved forwards or backwards during its rotation around its longitudinal axis within the device or a portion thereof.

In some embodiments, it is contemplated to actuate the displacing mechanism or the advancing mechanism or a corresponding mechanism intended for advancing, retracting or displacing the portion intended for folding and/or unfolding the implant by hand only. In other embodiments, a motor or the like is provided and intended to be used (solely or auxiliary) for advancing or displacing the portion intended for folding and/or unfolding the implant.

In certain of the embodiments in which such a motor is provided, the motor or main parts of it can be located, for instance, at or near the tip or in or at a tip portion of the implantation device. In other embodiments, the motor or main parts of it can be located at the implantation device's handle.

In some embodiments, the folding and/or unfolding means can be provided at or at least in connection with the implant such that it is or they are, respectively, operatively connected with the implant. The folding and/or unfolding means can be arranged such that it or they, respectively, can contribute to or effect the folding and/or unfolding of the implant which is attached to the device. The folding and/or unfolding of the implant by means of the folding and/or unfolding means can be effected when a force, a tension or stress or strain is applied or put, onto the folding and/or unfolding means or rather released from the folding and/or unfolding means. Such a tension, stress or strain can, for example, be induced or generated by an actuating device (e. g., a pulling device) which can be operated by a user.

In certain embodiments, the means for folding and/or unfolding the implant can pass through an inner space of the device. The folding and/or unfolding means of the implant can be arranged such that they leave the device through at least one opening of the device. Such an opening may be provided at one end of the device. However, the folding and/or unfolding means can leave the device also at any other suitable position and/or re-enter therethrough. The folding and/or unfolding means can leave the device all through the same opening, however, some of the folding and/or folding means can also leave the device through different openings and/or re-enter therethrough.

In some embodiments, the folding and/or unfolding means can comprise one or more tension threads or threads or strings or can consist thereof.

In particular embodiments, the folding and/or unfolding means are not identical to the device.

In some embodiments, the device is not intended to be implanted itself or to remain within the patient's body after the implantation procedure has been finished.

In certain embodiments, the device is intended to be separated from the implant after the implantation procedure has been finished.

In some embodiments, the device is configured to be separatable from the implant during normal use of the device. In certain embodiments, the device is not permanently attached to the implant or linked to it.

In some embodiments, the device is arranged within a central part or through-hole of the implant.

In certain embodiments, the device and/or the implantation device comprise attaching or interconnecting means. Such attaching or interconnecting means are intended and provided for attaching or interconnecting the device to or with, respectively, an implantation device. The attaching or interconnecting means can assist or support the attachment or interconnection of the device with or to, respectively, the implantation device.

In some embodiments, the means for attaching or interconnecting comprises a first section which is arranged rotatably in or at the device, in particular around a longitudinal axis of the device or of the implantation device.

In certain embodiments, the first section is preferably rotatably supported in or at the device.

In some embodiments, the means for attaching or interconnecting comprises a second section which is not arranged rotatably in or at the device, in particular not around a longitudinal axis of the device or of the implantation device.

In certain embodiments, examples for the first and the second section include lugs or noses or the like, but also recesses or notches, toothings or coggings, dogs, tooth or gear wheel structures, clip connections, plug-in connections, or the like. However, the device does not have to comprise particularly formed geometrical shapes.

Everything that was said herein about the first section of the means for attaching or interconnecting may undiminishedly also apply for the third section. This is, however, not mandatory.

Everything that was said herein about the second section of the means for attaching or interconnecting may undiminishedly also apply for the fourth section. This is, however, not mandatory.

In some embodiments, the first and the second section are present on or in or at the device.

In certain embodiments, the third and the fourth section are present on or in or at the implantation device.

In some embodiments, in order to establish a preferably tight or firm connection between, e. g., the first and the third section and/or between the second and the fourth section, the device can, for example, comprise male faces or terminals at the first and/or the second section and the implantation device can comprise female faces or terminals at the third and/or the fourth section or vice versa. As such, the connection between the device and the implantation device can resemble or be one plug-in connection or two plug-in connections.

In certain embodiments, the device is an implantation device tip. During preparation of implanting the implant attached to the device by means of the implantation device, the device, the catheter tip or the like can be attached to or interconnected with the implantation device by merely slipping or snapping on the catheter tip onto the implantation device in situ, for example, in the operating room or theatre.

In some embodiments, the implantation device is suited and/or configured or prepared for receiving at least one such device.

In certain embodiments, the implantation device comprises at least one device.

In certain embodiments, the device can be designed or constructed such that it is not susceptible by fluids such as, for example, liquids surrounding the implant or is damaged or destroyed by those. As such, it is advantageously also possible to interconnect the device and the implant before storage or transportation. Due to the separation of implantation device and device (tip of the implantation device, for example), both the implantation device and the device can be manufactured from different materials, in different processes and the like. Each can thus be manufactured to its best and independently from the other part.

In certain embodiments, due to the attaching or interconnecting means of the device, it is advantageously possible to establish or achieve a simple and uncomplicated connection between the device and the implantation device.

In some embodiments, as, the means for folding and/or unfolding the implant are interconnected with the portion for folding and/or unfolding the implant provided in the device and as the means for folding and/or unfolding are thus provided at the device alone and not also at the implantation device, the means for folding and/or unfolding can advantageously be kept short.

Moreover, due to their shortness, the means for folding and/or unfolding do not have to be guided through an interior of the implantation device to the hand of a surgeon as it has to be the case in other solutions of the applicant of the present application as well. The present solution is thus advantageously characterized in that the means for folding and/or unfolding do not have to be diverted or deflected, respectively, at all or only less, cannot experience any shear forces, experience less friction, and the like and the possibility of being displaced, entangled or the like is advantageously reduced.

Another advantage of certain embodiments can be that, due to shorter means for folding and/or unfolding the implant, a shorter range of move is required for the mechanism used. Thus, for the example of the thread as a means for folding and/or unfolding the implant it is known that the thread is subjected to a lengthening generated due to mechanical stress. This lengthening resulting in a reduced precision of the function of the entire mechanism may advantageously be prevented or, however, significantly reduced with respectively short threads as are possible.

Another advantage of some embodiments is that, due to their short design, less forces act on the means for folding and/or unfolding that do not have to be diverted around curves, bendings, and the like. This particularly applies at bending portions of the means and/or the device or the implantation device, respectively. The means such as, e. g., the one or more threads can be manufactured thinner, more simply, cheaper. This advantageously further allows for a cutting device for cutting the threads after a successful implantation of the implant being designed in a more simple, smaller and/or cheaper way.

A still further advantage of certain embodiments is the omission of the requirement of having to connect the means for folding and/or unfolding the device that can, for example, be threads or strings, respectively, with means for their operation that can be provided in the implantation device after attaching the device at the implantation device. A connection of the means for folding and/or unfolding of, e. g., the threads with the implantation device is not required. It is sufficient for the present invention to connect the device with the implantation device. A further connection is not required. In this way, in particular a connection of threads of the device with threads of the implantation device or the like which can be time-consuming and cumbersome can be omitted. The latter can advantageously contribute to maintaining the required sterility.

In some embodiments, it is thus possible that the means for folding and/or unfolding the implant are solely present in the device, e. g., at the implantation device tip. They do not have to extend across the entire implantation device. In this way, the implantation device does also not have to be designed such that the means can penetrate therethrough.

Another advantage of certain embodiments is that—in a correspondingly designed guiding structure that can extend, for example, spirally or helically along the portion for folding and/or unfolding the implant—a winding path of the means for folding and/or unfolding the implant that is designed in form of a thread in some embodiments can disperse or extend, respectively, along the longitudinal axis of the portion for folding and/or unfolding the implant. Thus, an only small space within the device, for example, between an outer sheath and the portion for folding and/or unfolding the implant rotatably supported therein is sufficient for winding the thread as close as possible at or around the portion for folding and/or unfolding the implant. In this way, the device can advantageously be designed having a smaller diameter. The same advantage can be obtained by providing an advancing mechanism or a displacing mechanism.

In some embodiments, the implantation device comprises an aligning device for aligning the apparatus at the implantation site.

In certain embodiments, the aligning device is capable of being transferred from a non-aligning position into an aligning position.

In certain embodiments, aligning the implantation device according to the invention is alternatively or additionally understood as aligning the medical implant.

In some embodiments according to the invention, aligning is alternatively or additionally understood as orienting the implantation device or the medical implant such that a user of the implantation device is aware of the position of the implantation device and/or the implant relative to a body tissue or a body structure or an anatomic condition of the implantation site, respectively, after aligning or that the user is given a corresponding hint by means of the alignment.

In certain embodiments, aligning is understood as aligning the implantation device and/or the medical implant.

In some embodiments, the aligning device is capable of being transferred from the aligning position into the non-aligning position as well.

In certain embodiments of the implantation device, the aligning device is or comprises a wire or a filament, respectively.

According to the present invention, the term “wire” or “filament”, respectively, may also define a plurality of wires or filaments, respectively, whenever a person skilled in the art recognizes the exchangeability of the terms.

In some embodiments, the aligning device comprises a through opening or passage opening, respectively, in at least one section thereof.

In certain embodiments, the through opening extends along the aligning device or a section thereof. The through opening may be present in an interior of the aligning device. It can be intended or provided and/or serve for transporting or guiding or directing a fluid from one end of the aligning device or of the section thereof to another end portion of the aligning device or of the section.

In some embodiments, the through opening is penetrable or permeable, respectively, for fluids in its longitudinal direction. The term “penetrable” or “permeable”, respectively, hereby refers to the ability of the aligning device to be flown through by fluids and/or to guide the said.

In certain embodiments, the aligning device is movable—namely either as a whole or in sections thereof—relative to the implantation device.

According to the invention a corresponding support may be provided, but does not have to be provided. A corresponding material combination may be provided, but does not have to be provided.

In some embodiments, the implantation device is tubular (i.e., having a hollow interior), such as, e.g., a hollow cylinder having a through opening in or along its interior. The implantation device may be designed symmetrically or asymmetrically, both relative to its through direction and also in another direction, in particular in a direction or plane perpendicular to the through direction.

In certain embodiments, a shaft of the implantation device is penetrable or permeable, respectively, in its interior in at least sections of its longitudinal direction. The shaft comprises a wall. The shaft comprises at least one shaft opening or shaft aperture, respectively. The at least one shaft aperture is preferably not arranged at the front side but at or on a lateral or envelop surface of the shaft. The shaft aperture is preferably a through opening establishing a connection between the interior and an exterior of the shaft of the implantation device. In certain embodiments, the aligning device can be delivered or passed or transferred from the non-aligning position into the aligning position through the shaft aperture.

In some embodiments, the shaft of the implantation device comprises a plurality of shaft apertures that are evenly or unevenly spaced around or across a periphery or a lateral surface of the shaft. Additionally or alternatively, the shaft apertures may be dispersed along a longitudinal direction of the shaft.

In certain embodiments, sections of the aligning device may enter and/or exit through the shaft apertures.

In some embodiments, the aligning device comprises two or more aligning sections that may be actuated independently from each other such that they can contact the tissue of the implantation site or of the implantation organ or of the organ independently from each other, respectively.

For this purpose, the aligning sections are in some embodiments capable of being transferred from the non-aligning position into the aligning position independently from each other.

In particular embodiments, the aligning device comprises or consists of a memory shape material.

In certain embodiments, the aligning device of the implantation device comprises at least one open or closed loopy or wound section. The latter can have the form of a loop or sling.

In particular embodiments, the open or closed wound section may have the form of a pig tail, a spiral, a helix, or the like.

In some embodiments, the implantation device comprises a reception area for receiving the implant.

In certain embodiments, the reception area is a shaft or has the form of a shaft.

The reception area can in some embodiments receive the implant releasably such that the implant can be delivered to the implantation site by means of the implantation device. After having reached the final implantation site, the implant may be released from the reception area optionally by using appropriate means or devices, respectively. Then, the implant stays at the implantation site while the reception area may be removed from the implantation site together with the other sections of the implantation device.

In certain embodiments, the aligning device of the implantation device is connected or intended or provided and suited for a connection with a means or device, respectively, for releasing a fluid for medical imaging.

In some embodiments, the aligning device is designed or embodied as a spring, in particular as a spiral or coil spring, and/or is formed from an appropriate—preferably an elastic or flexible—material such as, e.g., a plastic material or gum.

In certain embodiments, the implantation device comprises at least two or at least three different passages or apertures, respectively.

When according to the invention at least two or three different passages or apertures, respectively, are mentioned, this can, in some embodiments, refer to a respective different geometrical shape of the passages or apertures, respectively. In other words, the passages or apertures, respectively, may differ in their design.

In some embodiments, the “three different passages or apertures, respectively” may differ in their area size.

In certain embodiments, a passage or aperture, respectively, is the open passage between an exterior of the implantation device or of the shaft of the implantation device and an interior of the implantation device or of the shaft of the implantation device.

In some embodiments, the passages or apertures, respectively, may each comprise a range of geometrical designs. Thus, the passages or apertures, respectively, do not have to have an unchangeable design or size as long as the respective function (and optionally only this function) is possible within the respective range of the geometrical design. Within the limits predetermined by means of the range, the respective passages or apertures, respectively, may therefore—to all intents and purposes—be variable.

In certain embodiments of the method of attaching and/or releasing an implant, the method may comprise transferring the aligning device from the non-aligning position into the aligning position and/or vice versa, after having inserted the implantation device at the implantation site.

In some embodiments of the methods according to the invention, the methods may comprise directing a fluid for medical imaging through a lumen of the aligning device.

Among the advantages achievable according to the invention is that the mechanical stress or impairment of the tissue of the implantation site in general is in certain embodiments at best only little.

This advantage can even be increased in that the aligning device or the aligning sections thereof are in some embodiments wires or filaments, respectively, e.g., made from or comprising Nitinol, however, in any case, sections having a certain flexibility. This can also favor a gentle handling with the tissue of the implantation site as the mechanical stress applied on the tissue is low. Bleedings, wounds, irritations, and the like can be prevented.

One of the advantages achievable is further that both implanting as well as imaging the implantation site is possible at the same time by using the implantation device in certain embodiments. In these embodiments, there is no further device or means required for this purpose in addition to the implantation device for fulfilling both functions. This can both facilitate the handling of the required instruments as well as require an only smaller access or fewer accesses than the solutions known.

Another advantage is that, in some embodiments, a proper alignment—or more proper as compared to the state of the art—to the morphology of the implantation site is possible., it is thus, e.g., possible to achieve an appropriate alignment even for two-part cardiac valves or the connection sites thereof with the heart muscle, respectively, as, due to the multiple separation of the aligning device, another number of aligning sections is used than is, e.g., provided or required for cardiac valves comprising three valves. Thus, in some embodiments, if needed, e.g., not three but only two aligning sections may be used or transferred into the aligning position. Moreover, the two aligning sections used can exit the implantation device appropriately at positions being suitably spread across the periphery of the implantation device or the shaft thereof. This allows a further advantageous flexibility during use of the implantation device in some of its embodiments. Thus, the latter can be used for, e.g., aligning any arbitrary one of the cardiac valve prostheses known during the implantation thereof.

A still further advantage of the present invention which can be achieved in certain embodiments is the simple match of the aligning device or the aligning sections thereof. This can, for example, be achieved by means of a memory shape (or shape memory, respectively,) material. Thus, the aligning device or sections hereof may consist of Nitinol wires or filaments, respectively, that can be brought into an appropriate form easily, which they are able to reassume after omitting external limitations.

In some embodiments, the implantation device and/or a device for folding and/or unfolding an implant comprise at least an apparatus configured for inserting and/or folding and/or unfolding the implant by means of at least one tension thread.

In particular embodiments, the folding and/or unfolding device, which may be called in the following folding device, comprises a shaft.

In certain embodiments, the folding device comprises at least one tensioning device for altering a form or shape, a geometry or a folding state of the foldable and/or unfoldable implant by means of the at least one tension thread.

In some embodiments, the shaft of the folding device comprises in at least one shaft section thereof a plurality of individual shaft fibers.

In some embodiments according to the present invention, altering a form or shape of the implant means reducing or increasing a diameter, in particular an outer diameter, of the implant. Alterations of the diameter may be accompanied by any kind of alteration of the implant's length or any other alteration, or may be not.

In some embodiments, the at least one tension thread is a thread or filament or yarn, respectively. It can be designed or embodied similar to a surgical sutural thread or it can be such a surgical sutural thread. It can be designed or embodied as a rope or a cord or twine or string, respectively. It can be designed or embodied as a chain comprising a plurality of chain members engaged with adjacent chain members.

According to the present invention, whenever reference is made to a thread or tension thread, the terms may include a plurality of threads or tension threads as well insofar as a person skilled in the art recognizes the exchangeability of the terms.

In certain embodiments, the shaft of the folding device is in at least one section thereof embodied rigidly. In some embodiments, the shaft of the folding device is in at least one section thereof embodied such as to be bendable in one or more directions (i. e. it may be bent in a longitudinal direction or in a direction of the shaft's width, in both directions or in any other direction). In some embodiments, the shaft is embodied extendably or stretchably. In other embodiments, the shaft is embodied stiffly or inflexibly.

In some embodiments, in the moment of unfolding or folding, the implant is loosely arranged or attached to or at or on a receiving area of the folding device. In certain embodiments, the implant is thereby connected with the receiving area only by means of the tension threads.

In some embodiments, a shaft fiber of the folding device is permeable or patent (like a blood vessel) within its interior in at least sections of its longitudinal direction or along its entire length. In those embodiments, the shaft fiber comprises a wall.

In certain embodiments, at least one of the tension threads (or all of them) is partly arranged within an inner space of the respective shaft fiber and extends from there to an outside of the shaft fiber through the shaft opening.

In some embodiments, at least one of the tension threads (or all of them) exits from an inner space of the shaft fiber through one shaft opening. In other embodiments, at least one of the tension threads (or all of them) exits from the inner space through two or more shaft openings.

In certain embodiments, the at least one shaft opening is provided at or on the front surface of the shaft fiber. In other embodiments, it is arranged at or on a circumferential surface or lateral surface area of the shaft. Preferably, the shaft opening is arranged in or within a tip area of the shaft fiber or in or within a proximal area of the shaft fiber.

In certain embodiments, the shaft fiber comprises a plurality of shaft openings uniformly or non-uniformly distributed or arranged along or about a periphery or along or about a circumferential surface or lateral surface area of the shaft or of the shaft fiber. Additionally or alternatively, the shaft openings may be dispersed along or about a longitudinal direction of the shaft or of the shaft fiber. For example, in some embodiments, shaft fibers may have two or more shaft openings which are arranged under different distances between the respective opening and the tip or one end of the corresponding shaft fiber.

In certain embodiments, at least one or all of the shaft fibers are arranged such that they do no move relatively to the folding device in a longitudinal direction of the folding device upon folding or unfolding the medical implant.

In some embodiments, tension threads for folding and/or unfolding the implant enter and/or exit through the shaft opening.

In certain embodiments, during the use of the folding device, shaft fibers of the plurality of individual shaft fibers are always present in bundled form in at least one first section of the shaft section. In contrast, in a second section, they are provided for moving or drifting away from each other during use of the folding device.

In some embodiments, the second section is closer to the tip of the folding device than the first section.

In certain embodiments, the first section directly merges with or passes over into the second section.

In some embodiments, the individual shaft fibers are arranged in contact to each other in the first section such that there is no lumen such as, e. g., a central lumen, for example a lumen usable during the use of the folding device for fulfilling particular functions, provided between the shaft fibers in the first section. Spoken differently, the shaft fibers are arranged closely or at close quarters.

In some embodiments, the term “individual shaft fibers”—when used discretely—comprises all shaft fibers present of the plurality of the entirely present individual shaft fibers; in other embodiments, it only comprises some of them.

In certain embodiments, the number of individual shaft fibers is set to two shaft fibers; in other embodiments, the number is set to three, four, five, six, seven etc. The number may be a great number; it may exceed ten or twenty and comprises every natural number up to at least 30 or 40.

In some embodiments, a great number of individual shaft fibers advantageously allows for separating the part or rim portion of the implant (for example, the periphery of the implant) which experiences an action by means of the tension threads for folding/unfolding, that exit from the individual shaft fibers into a great number of subunits. The inventors of the present invention have recognized that, for example, dividing the periphery into many but small or short sectors or rim portions upon attaching the tension threads at or on the implant, in certain embodiments, favors a uniform folding or unfolding the implant. Additionally, such dividing into a great number of sections may advantageously avoid any buckling or bulging or denting of the periphery.

In certain embodiments, a great number can be any numerical value between 3 and 40, for example, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40. Greater values are encompassed by the present invention as well.

In some embodiments, neither the individual shaft fibers nor sections thereof are arranged within the interior or material of a wall of an envelope, an outer boundary or limitation, or the like of the folding device.

In particular embodiments, neither the shaft nor sections thereof are arranged within the interior or material of a wall of an envelope, an outer boundary or limitation, or the like of the folding device.

In certain embodiments, the individual shaft fibers are provided such that they cannot be shifted or moved relative to the remainder of the folding device in a longitudinal direction thereof.

In some embodiments, the shaft or shaft fibers of the plurality of individual shaft fibers each comprise one or more shaft openings. The one or more tension threads can enter into and/or exit from the respective shaft fiber or from the shaft through the shaft openings.

In certain embodiments, such shaft openings are solely provided for allowing tension threads to enter in or into and/or leave or exit from the respective individual shaft fiber and/or from the shaft.

In some embodiments, the individual shaft fibers are designed or embodied to comprise one or more through-openings (extending into a longitudinal direction of the shaft fiber) or one or more hollow interiors. These through-openings or hollow interiors may allow guiding one or more tension threads through the shaft fiber, e. g. from the tensioning device of the folding device to a shaft opening or to an exit opening at the tip portion of the shaft fiber.

In some embodiments, the tension threads are arranged within an interior of the shaft fibers or of the shaft such that they can be shifted or moved relative to the respective shaft fibers.

In some embodiments, the shaft, the individual shaft fibers and/or the tension threads do not comprise any devices for establishing a hook engagement with the implant.

In some embodiments, some or all of the tension threads are connected with the implant by solely entangling or entwining the implant or a part or section or portion thereof.

In certain embodiments, during a state of use of the folding device, shaft fibers of the plurality of individual shaft fibers are arranged movably in or forth from (in the direction towards the tip of the implantation or folding device) at least the second section of the shaft respectively independently of each other and/or independently of the position of the implant relative to the folding device. Differently spoken, they can move away from each other and/or move towards each other in or within the second section.

In some embodiments, the shaft comprises in at least one section thereof a device for bundling individual shaft fibers of the plurality of individual shaft fibers.

In certain embodiments, there are provided more than just one device for bundling (but two, three, four, and so on, devices of this kind). Additionally or alternatively, in some embodiments, the device for bundling comprises not just one means, e. g. having the shape of a collar, but more than one means (e. g., two, three, four, and so on, means).

In particular embodiments comprising more than one device for bundling or means for bundling, the individual devices or means are provided on the shaft fibers while being spaced apart from each other. The particular space or distance chosen or set may advantageously contribute to setting or predetermining the stiffness, bendability and other mechanical features of the shaft fibers. This may be true for the shaft fibers' parts arranged between the devices or means for bundling. It may also be true for the parts of the shaft fibers that are not bundled but allowed to move freely with regard to each other.

In some of the embodiments comprising more than one device for bundling or means for bundling, a (that is, one or more) core element or a (that is, one or more) interconnecting element is provided on, at or within the bundle of shaft fibers. The core element or interconnecting element may also advantageously contribute to setting or predetermining the stiffness, bendability and other mechanical features of the shaft fibers. The core element or interconnecting element may be attached to one, two or all of the devices or means for bundling. However, it may not be attached as well. The core element or interconnecting element may be provided to be extendable and to change its length, for example, when a distance between neighbouring, adjacent or interacting devices for bundling or means for bundling is changed or adapted to need.

Both providing more than only one device for bundling or means for bundling and providing a core element or the like may in certain embodiments of the present invention allow for keeping the shaft fibers in parallel in use along a certain or even predetermined distance. Again, this may also advantageously contribute to setting or predetermining the stiffness, bendability and other mechanical features of the shaft fibers, both in the vicinity of core element or device or means for bundling and also in the second section of the shaft in which the shaft fibers are intended to move, wander or migrate freely in case of need.

In certain embodiments, the device for bundling is designed or embodied as a ring encompassing the individual shaft fibers to be bundled and inhibiting the shaft fibers from drifting or moving away from each other. In some embodiments, the device for bundling is designed or embodied as a clamp, a protrusion or a constriction of the folding device, or the like.

In certain embodiments, the device for bundling individual shaft fibers is arranged to be shiftable along a longitudinal extension of the folding device. Additionally or alternatively, the device for bundling may be alterable or manipulatable or engineerable in any other way. For example, the device for bundling may be manipulated by setting or altering a gap or play between shaft fibers and the device for bundling limiting or encircling the shaft fibers. Additionally or alternatively, the device for bundling can be provided for being used at or on different sections of the folding device along the longitudinal extension thereof. The afore-mentioned manipulations may advantageously alter or adapt to the need, respectively, the stiffness or rigidity of the individual shaft fibers in or within the second section.

In particular embodiments, a device for bundling such as specified above is not provided. In some embodiments, it is not possible to distinguish a first section from a second section (such as specified above and below) or required.

In some embodiments, individual shaft fibers are designed or embodied and provided or prepared for moving or bending or tilting, or the like, towards a rim portion of the implant when applying tension onto the implant by means of the tension thread extending through the said individual shaft fiber.

“Moving towards” is in some embodiments to be understood as a deviation of at least one section of the individual shaft fiber (mainly in the second section or in a tip area of the individual shaft fiber) from a position that is arranged closer to a center of a cross section of the folding device into a position that is arranged more radially as compared to the first position, e. g. into a rim area or towards a rim portion.

In certain embodiments the bundle of shaft fibers can be (or are) arranged in a circular manner.

In some embodiments, the shaft fibers (e. g. nine shaft fibers in total) are arranged in a circular manner in both the unfolded and/or the folded state of the medical implant.

In certain embodiments, a rim portion is a section, in particular a section of a circumference of the implant or a main part thereof, that is present in an area of an—in relation to the implant—exterior wall or envelope, for example the exterior wall or envelope.

In some embodiments, the rim portion comprises a part of the foldable material of the implant. The rim portion may be a curve-shaped part of an outer limitation or of a wall (e. g. a mesh, grid, strut or bar structure) of the implant. The rim portion may be a tart-like structure.

In certain embodiments, tension threads exiting from individual shaft fibers are connected with a rim portion of the implant for applying a force onto the implant and/or onto the rim portion. In some embodiments, tension threads exiting from at least two or more individual shaft fibers are connected with the said rim portion, or parts thereof.

In some embodiments, the rim portion which is folded or unfolded by means of a particular shaft fiber or by means of the one or more tension threads of the shaft fiber, respectively, is only a part of the foldable and/or unfoldable periphery of the implant or is the entire foldable and/or unfoldable periphery of the implant.

In certain embodiments, the rim portion does not comprise the entire periphery, whereas, in other embodiments, it indeed does.

In some embodiments, tension threads exiting from individual shaft fibers are connected with a rim portion in an overlapping manner for applying a force onto the rim portion of the implant. In those embodiments, it is intended to fold or unfold a particular rim portion or a part thereof by means of two, three or more tension threads exiting from different individual shaft fibers. In this way, an overlap of several tension threads is achieved in an area of a particular rim portion. This may advantageously contribute to a more uniform folding of the implant.

In certain embodiments, tension threads exiting from individual shaft fibers are connected with differently large, broad, long or in any other way different rim portions of the implant for applying a force on the said rim portions. Thus, a first rim portion may have a first arc or curve length x, a second rim portion may have a second arc or curve length 2x. This may advantageously allow for or contribute to a more uniform folding of the implant even in cases in which the implant does not behave in a mechanically uniform way over its entire periphery upon folding.

In certain embodiments, individual shaft fibers on the one hand and the implant on the other hand are adapted, chosen or fit to each other as regards their mechanical properties. In certain embodiments, this may be effected such that, during the process of folding the implant, a first force or tension required for moving the shaft fibers in a section thereof, in particular in an area of a shaft opening for tension threads, from their longitudinal alignment or in a direction of the radial extension of the implant is lower than a second force or tension. The second force or tension is a force or tension required for effecting a folding or the beginning or an appreciable beginning of a folding of the implant by means of the tension threads connected with the implant that exit from the shaft openings. Said in a more simple manner, in some of those embodiments, upon application of tension, the individual shaft fiber firstly moves in a—for example, radial—direction towards a rim portion of the implant upon applying tension by means of the tension threads exiting from the shaft fiber, prior to beginning any folding of the respective rim portion. This adaptation or adjustment of properties of the individual shaft fibers (such as bendability, flexibility, elasticity, or rigidity) with respect to the properties of the implant may ensure that, upon applying tension by means of the tensioning device, the individual shaft fibers firstly automatically move into a position in which the force applied or to be applied by means of the tension thread is applied onto the implant or onto the rim portion in or under a desired angle.

In some embodiments, the implant is connected or intended to be interconnected with the folding device by means of tension threads such that the tension threads (independently of each other or in an overlapping manner) interconnect with a great number of peripheral sections of the implant. A great number may be any numerical value between 3 and 40, for example, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40. Greater values are encompassed by the present invention as well.

In some embodiments of the set, the implant is connected or intended to be interconnected with the folding device by means of tension threads such that the tension threads may act and/or contact the medical implant not only at one end of the medical implant but at least at two or more sections of the medical implant which are longitudinally offset from each other.

In certain embodiments of the methods, the methods may comprise altering a tension applied onto the implant by means of at least one tension thread. The tension is controlled by means of altering a length of the one or more tension threads exiting from the interior of the shaft or of the shaft fiber.

In some embodiments of the method, the method comprises shifting or otherwise manipulating or engineering the device for bundling individual shaft fibers. In this way, the rigidity, stiffness, elasticity, or the like, of the respective individual shaft fibers may be set according to need—in particular with regard to the second section.

In some embodiments of the methods according to the present invention, prior to its implantation, the implant is connected with the folding device and/or implantation device by means of tension threads such that the tension threads (independently of each other or in an overlapping manner) interconnect with a great number of peripheral sections of the implant.

Some or all of the following advantages and the advantages mentioned above can be achieved in some, certain or all embodiments.

In some embodiments, one advantage achievable is to advantageously reduce or even completely avoid buckling or bulging or denting of the implant resulting from applying a force onto the implant—mainly onto the periphery thereof—by means of the tension threads.

Another advantage of certain embodiments is a uniform folding of the implant even in a case in which an implant is designed inhomogeneously as regards the mechanical properties of the implant along the periphery thereof.

According to yet another advantage of some embodiments—due to the capacity of the individual shaft fibers to move, migrate or wander—the tension threads' exit from exit openings of the shaft fibers may be effected in or under angles at which the tension threads will not suffer particular friction or shear stress at the exit or shaft openings. In connection therewith, a further advantage could be that the force for folding—again due to the possibility of the individual shaft fibers to move, migrate or wander—is acting on the implant under particularly advantageous angles.

In some embodiments, the folding device further includes at least one tensioning device for altering or amending a shape of the foldable and/or unfoldable implant by the tension thread or by at least one first string connected to the tension threads.

In certain embodiments, the folding device includes a clamping mechanism, a clamping device or a clamping section (hereinafter: clamping mechanism) for clamping at least one section (for example a free end) of at least one of the tension threads.

In some embodiments, the medical implant comprises a set of tension threads for folding or unfolding the medical implant or is connected or provided herewith, the set of tension threads being designed as set forth herein.

In certain embodiments, the set of tension threads comprises at least one first string, at least a first tension thread and at least a second tension thread.

In some embodiments, the first string comprises at least a first guiding element for guiding through the first tension thread and a second guiding element for guiding through the second tension thread.

In certain embodiments, both the first tension thread and the second tension thread are attached to the first string.

In some embodiments, the methods according to the present invention may comprise providing a folding device or a set of tension threads. They may also comprise clamping at least one section of at least one tension thread by a clamping mechanism.

In particular embodiments, the diameter of the implant is arranged in the reception area in a plane perpendicular to a main flow direction of the implant in case fluids flow through the implant after its implantation.

According to the present invention, the term thread or tension thread may also define a plurality of threads or tension threads whenever a person skilled in the art recognizes the exchangeability of the terms.

In some embodiments, the pulling device and the tension thread are intricate with each other.

In certain embodiments of the present invention, the transfer (or the transmittal, respectively) of force or tension between the pulling device and the tension thread is achieved by a non-form closure connection.

In certain embodiments, the pulling device is embodied as at least one pulling thread or wire or consists of at least one pulling thread or wire.

In certain embodiments, “clamp” or “clamping” means to fasten the section of the thread within or by the clamping mechanism. It may be understood as to fasten the thread to another part of the folding device such as the first or second clamping section. The term may be understood as to maintain the section of the thread within or by the clamping mechanism in a manner such that the clamped section of the thread cannot be withdrawn from the clamping mechanism by the tension device under normal use conditions unless the releasing device has been operated. The term may be understood so as press two parts towards each other strongly enough so as to keep an object (here: the section of the thread) arranged between the two parts in place. The term may be also understood as to press the section of the thread against one first clamping section by a second clamping section, wherein at least one of the clamping sections is not movable with regards to the shaft or the entire folding device.

In some embodiments, the term “clamping mechanism” relates to a part of the folding device or a set of parts thereof that work together in order to clamp the section of the thread in a releasable manner. The releasing device may be arranged to be operated by the surgeon.

In certain embodiments, the first and the second clamping section may together be understood as a clamp for the thread when clamping the section of the thread between them.

In some embodiments, the clamping mechanism consists of the first and the second clamping section. In certain embodiments, the clamping mechanism comprises the first and the second clamping section.

In certain embodiments the first clamping section and the second clamping section of the folding device are arranged such that they are inclined to the longitudinal axis of the folding device, its shaft, and/or the reception or retaining area for receiving the implant.

In some embodiments, the “releasing device” for releasing the clamp, the clamping mechanism or the clamping of the section of the thread is to be understood as a device for removing restrictions acting on the section of the thread, for removing the section of the thread from at least one of the first or second clamping section, or vice versa, for removing at least one of the first or second clamping section from a fixed position, allowing the section of the thread to move or to be withdrawn, e. g. by the pulling device or by the tensioning device.

In certain embodiments, the clamping mechanism does not form part of the tensioning device.

In some embodiments, a first end of the thread is clamped by the clamping mechanism, whereas another part, in particular a second end opposite to the first end of the thread is interconnected with the tensioning device.

In certain embodiments, the folding device comprises a releasing device for releasing the clamped section of the tension thread from the implant by releasing the clamping mechanism.

In some embodiments of the folding device the clamping mechanism is adapted for clamping the at least one section of at least one of the tension threads between a first clamping section and a second clamping section of the folding device. Alternatively, the clamping mechanism consists of such first and second clamping sections.

In certain embodiments, the first clamping section and the second clamping section of the folding device are arranged such that they may slide relatively to each other (for example, mainly or exclusively in a direction parallel to the main extent or the longitudinal direction of the folding device).

In some embodiments, the second clamping section of the folding device is arranged in an inner space of the first clamping section of the folding device.

In certain embodiments, the shaft includes at least one shaft aperture through which tension threads for folding and/or unfolding the implant may enter and/or exit the inner lumen of the shaft.

In particular embodiments, neither the first nor the second clamping section is arranged on or at the implant.

In some embodiments, the implant is a stent or a cardiac valve assembly.

In particular embodiments, the folding device comprises at least one implant connected with tension threads or with a set of tension threads for folding or unfolding at least one medical implant. The combination of an folding device and at least one implant connected thereto by tension threads or a set of tension threads for folding or unfolding the medical implant may also be called a “set” (albeit different from the set of tension threads, of course).

In some embodiments, the set of tension threads comprises at least one first string, at least a first tension thread and at least a second tension thread. The first string comprises at least a first guiding element for guiding through the first tension thread and a second guiding element for guiding through the second tension thread. Both the first tension thread and the second tension thread are attached with the first string.

In certain embodiments both the first tension thread and the second tension thread are attached with the first string such that they are fixed to the first string and/or such that the ends or portions of the threads by which they are fixed to the first string cannot move relatively to the first or second guiding element. For example, the first tension thread and the second tension thread may both be knotted to or integral with the first string. In embodiments with more than two tension threads, more than two tension threads are fixed to the first string.

In some embodiments, at least one of the first guiding element and the second guiding element are rings. In certain embodiments, the first tension thread and the second tension thread may slide through the first guiding element and the second guiding element forth and back.

In certain embodiments the first string is connected to a multitude of tension threads, for example to—at least or exactly—six tension threads of which three are guided through the first guiding element, wherein three of them are guided through the second guiding element.

In certain embodiments, neither of the first tension thread nor the second tension thread is directly connected to a tensioning device of an implantation device for altering a shape of the foldable and/or unfoldable implant. Rather, they are in direct contact with the first string. It is via the first string that they are in indirect contact with the tensioning device.

In certain embodiments at least the first tension thread is connected to the first string, preferably at a first end section of the first string. Likewise, the second tension thread is connected to the first string, preferably at a second end section of the first string.

In some embodiments the first end section and the second end section are opposed ends of the first string.

In certain embodiments the first tension thread is connected with or fixed at its first end to the first string, and wherein at least the second tension thread is connected with or fixed at its first end to the first string.

In certain embodiments, the methods may encompass releasing the clamped section of the tension thread from the implant by releasing the clamping mechanism. In some of these embodiments the tension thread may then be withdrawn from the implant, e. g. by the tensioning device or the surgeon.

In certain embodiments, the releasing device is not a wire or a thread (or a multitude thereof, respectively).

In some embodiments, the releasing device is not embodied as a lock wire or lock thread that is withdrawn from the folding device so as to allow the tension threads to be removed from the folding device after final placement of the implant.

In certain embodiments, the releasing device does not comprise hooks and/or does not comprise rings for guiding or limiting tension strings or threads.

In some embodiments, the releasing device is embodied and/or intended to stay with the folding device even after termination of the implantation of the implant.

In certain embodiments, the releasing device may not be separated from the folding device except for cleaning or the like.

In some embodiments, the releasing device is embodied such that it is intended or configured to be used, only within the patient's body.

In some embodiments, at least one of the first or the second clamping device is or includes at least one sleeve. The sleeve may preferably be made tube-like (that is, it may have a hollow inside), like a hollow cylinder, like a ring or the like. The sleeve may be manufactured symmetrically or asymmetrically, both relative to its opening direction and in another direction, particularly in a direction or plane perpendicular to the opening direction or the fluid passage direction, as well.

In some embodiments of the folding device, the releasing device is no cutting device for cutting through the tension thread, and it does not comprise one.

In certain embodiments, tension threads for folding and/or unfolding the implant may enter and/or leave the folding device through the shaft aperture.

In particular embodiments, the releasing device is identical to the clamping mechanisms or comprises part of it. In these embodiments, there is one device that may both clamp and subsequently also release the thread when being operated in a “reverse manner”.

In certain embodiments, the first or the second clamping section is preferably arranged in a shiftable manner.

In some embodiments, the first clamping section surrounds or embraces the shaft in such a way that the shaft is located inside the first clamping section and the first clamping section. Alternatively, the first clamping section may be located inside of the shaft such that the shaft is surrounding the sleeve.

In certain embodiments, the folding device includes a releasing device which is arranged for exerting tension on the first or second clamping device in at least one state of use.

In some embodiments, the releasing device exerts a tension on the first or second clamping device substantially or exclusively in a longitudinal direction of the shaft

In certain embodiments, the releasing device is arranged for pushing or for pulling the first or second clamping device in order to release the clamped section of the thread. It may be embodied as a pulling device as, e.g., a thread or the like. In other embodiments, said device is embodied as a pushing or twisting device.

In some embodiments, the releasing device enables a transition from the clamping position into the release or non-clamping position.

In certain embodiments; said releasing device is arranged such that it enables a transition from the clamping position into the release or non-clamping position independently from an operation of the tensioning device.

In certain embodiments, the methods may comprise altering the tension that is exerted on an implant by using at least one tension thread. The tension is preferably controlled by altering a length of the pulling device by which it extends out of the interior of the shaft or sections thereof.

In some embodiments, at least one of the folding device, the implant and the set of tension threads comprises exclusively, i.e. only, (one or more) materials that are MRI (short for: magnetic resonance imaging) compatible. In certain embodiments, at least one of the folding device, the implant and the set of tension threads comprises exclusively (one or more) materials that are not magnetic, ferromagnetic, or both. In some embodiments, at least one of the folding device, the implant and the set of tension threads does not comprise metal or any metal alloy.

In particular embodiments, the methods may comprise monitoring or controlling the position of the folding device or the implant, or both, by means of magnetic resonance imaging (MRI) during or after implementation, advancing or delivering of the implant.

In certain embodiments, all instruments used for implanting or advancing the implant are MRI compatible.

In some embodiments, the folding device comprises a detachable tip. In certain embodiments, the tip (and only the tip) comprises the first and the second clamping section.

In particular embodiments, the first clamping section is connected to a first connecting device of the tip or the shaft of the folding device by a thread such that the first clamping section can be moved along the shaft of the tip by rotating the first connecting device whereas the first clamping section itself is not rotated.

In some embodiments, the tip of the folding device or implantation device comprises a rotational clamping mechanism such that the first clamping section can be moved to or away from the second clamping section by rotating the first connecting device whereas the first clamping section itself is not rotated.

In particular embodiments, the first connecting device may have an crown-shaped section, it may comprise a gear pattern, it may have teeth or any other engagement device, due to space constraints preferably at its front surface (not on its sided surface), configured to be engageable with a second, rotably arranged connecting device of the apparatus in a manner such that via rotating the second connecting device the first connecting device may be rotated.

In certain embodiments, the clamping surface of at least one of the first and second clamping sections is inclined against a longitudinal axis of the folding device or the tip thereof by between 10 and 30 degree, preferably between 10 and 20 degree, most preferably about 15 degree.

In some embodiments, the entire rotational clamping mechanism, including or consisting of at least the first and the second clamping section and the first connecting device, is provided on or at the side of the tip.

In certain embodiments, the first clamping section has a clamping surface, is movably arranged, comprises a thread (preferably arranged on an inner surface thereof), has a slot or groove (which preferably is straight) into which a protrusion such as a pin is inserted, whereas the protrusion is fixed to the tip, but cannot be rotated.

In some embodiments, the the first clamping section has a clamping surface, is movably arranged, comprises a thread (preferably arranged on an outer surface thereof), has a slot or groove (which preferably is straight) into which a protrusion such as a pin is inserted, whereas the protrusion is fixed to the tip, but cannot be rotated.

What is said in here with regard to one tension thread holds also true for a multitude of tension threads whenever this does stand in contrast to the general idea of the present invention.

Further, clamping the threads used for folding or unfolding the implant allows for a safe temporary connection between the folding device with the threads. At the same time, since the clamping mechanism may be released after implantation, in some embodiments the present invention allows for an easy removal of the threads from the implant just by releasing or terminating the clamping effect and by pulling the thread out of the folding device. In particular, for removing the threads from the implant or from the folding device, no thread has to be untied, unknot, undone or even cut. Hence, at least one end of the tensioning threads does not have to be interconnected to or released from e. g. the implant. This does not only safe time and effort but also contributes to a safe handling of the implant upon implantation. Also, providing a reliable clamping mechanism is less demanding regards observing tolerances in the production process of the folding device.

In certain embodiments, providing a groove, a sliding block guiding, a slotted guide, or the like that avoids twisting or rotation of the first clamping device with regard to the second device or vice versa contributes to releasing the clamped section of the thread once the releasing device has been operated. In contrast, twisting or rotating might incur an accidental clamping of the thread between part of the apparatus other than the first and second clamping sections.

Providing in some embodiments at least one of the folding device, the implant and the set of tension threads to be MRI compatible allows advantageously for controlling the location and orientation of the folding device or the implant, or both, by MRI upon use of the folding device or implantation of the implant. No heat, sparks or artefacts are generated during MRI because of the materials chosen for the folding device or the implant.

Among the advantages achievable is the opportunity in certain embodiments of independently actuating tension threads. This is due to the self balancing design provided in which the pulling thread is entangled with the first string or wound around without being fixed to it. This way, the first string may move forth and back within the loop of the pulling thread. Thus, it is possible to specifically fold and/or unfold implants having a first and a second tension thread, or a plurality of tension threads, which act on different parts or sections of the implant upon folding the latter. Parts or sections of the implant can thus be folded or unfolded though other parts or sections of the implant have already been completely folded or unfolded. This can i.a. be reasonable when an unfolded implant and the implantation site do not completely match in their dimensions, or if the implant does, e.g., not have a uniform shape over its entire length. For more details regarding the idea of an self-balancing design it is referred to WO 2011063972 A8. See, in particular, FIGS. 2 and 2A thereof. The entire respective content of WO 2011063972 A8 is incorporated herewith by reference.

In some embodiments, some or all of the individual shaft fibers have each at least one shaft opening for passing through the tension threads.

In certain embodiments, the implant comprises apertures through which tension threads are guided or passed.

In particular embodiments, tension threads which pass through (i.e., enter into or exit from) one particular (or many) of the shaft openings of a particular individual shaft fiber also pass together through (i.e., enter into or exit from) a common aperture of the implant.

In certain embodiments, unfolding means the opposite of folding.

In some embodiments, a common aperture is to be understood as a single aperture through which more than one tension thread are commonly guided or passed through. However, in other embodiments according to the invention, a common aperture means a particular site where a pair of tension threads are guided through the circumference of the implant. That common aperture may be subdivided into two or more sub-apertures which, however, all belong to a functionally ‘common’ passage through the circumference of the implant. Two or more sub-apertures may even then be referred to as a common aperture within the sense of the present invention, as long as an angle formed between the pair of tension threads is not substantially changed by the fact the common aperture is comprised by not by one but by a multitude of apertures.

In certain embodiments, the term ‘one (particular) common aperture’ encompasses all apertures that are arranged on one (particular) post or strut at one and the same spot or in either a proximal or distal section thereof.

In some embodiments, one or each of the common apertures are provided in one or more posts or struts of the implant which extends in parallel to a longitudinal axis of the implant (in an unfolded or folded state outside of the body).

In certain embodiments, all of the common apertures are provided only in such posts or struts of the implant.

In some embodiments, the posts or struts are arranged to connect a distal ring-shaped element of the implant with a proximal ring-shaped element thereof. The posts or struts may be arranged to maintain a distance or an unchangeable distance between the distal and the proximal ring-shaped elements.

In certain embodiments, the at least one opening of the shaft fiber is an opening in the end face of the shaft fiber.

In some embodiments, the at least one opening of the shaft fiber is an opening in the shaft or circumference or envelope of the shaft fiber.

In certain embodiments of the set, the shaft openings of the shaft fibers and the apertures of the implant are matched such that tension threads which pass through one or more shaft opening(s) and which also pass together through a common aperture do not—or not substantially—change the angle between them during folding and/or unfolding.

In some embodiments, the implant, shaft fibers and pairs of tension threads are arranged such that in an area of the shaft openings the respective tension threads belonging to one pair of tension threads do not diverge upon folding and/or unfolding the implant.

In some embodiments according to the invention, some or all of the tension threads, i. e. at least one tension thread, do not encompass the whole circumference of the implant. In certain embodiments according to the invention, one or more of the tension threads re-enter the lumen of the implant through apertures provided within the circumference or rim of the implant that are, for example, adjacent to the aperture through which the respective tension thread has exited from the lumen. In some embodiments according to the invention, some or all of the tension threads are provided to re-enter the lumen by an aperture provided in the rim that is different from the aperture through which the particular tension thread has exited from the lumen to an outside of the implant. In particular, any tension thread may re-enter the lumen by the next aperture, the next but one, next but two, next plus three, or the like, on the circumference or on the rim.

Please note that in any embodiment according to the present invention the number of apertures may always be identical to the number of fibers. However, the number of apertures may as well differ from the number of fibers.

According to yet another advantage of some embodiments, the tension threads which pass through one or more shaft opening(s) of a particular individual shaft fiber and which also pass together through a common aperture of the implant are guided more or less in parallel between shaft opening and aperture. Further, even upon folding or unfolding of the implant, the pair of tension threads do remain parallel (or the angle between does not change or not substantially change). This way, in particular weaker stents or implants (weak being related to the force required for folding or crimping the implant) may be folded or crimped without buckling, even if only a small number of apertures is provided. Otherwise, upon folding or crimping, the implant may just buckle. With the present invention, single sections of the circumference or rim portions are compressed by forces applied onto the rim portions between the respective apertures. Hence, the force applied acts advantageously also in a circumferential direction.

In some embodiments, at least one of the implant delivery device and the implant comprises a releasing string knotted to tension threads by at least one knot.

In certain embodiments, the knot is configured such that it can be released or opened upon pulling the releasing string.

The methods according to the present invention may comprise in some embodiments releasing the tension thread by pulling the releasing string in order to unknot, untie or untangle the knot.

In some embodiments, at least one of the implant delivery device and the implant further comprises a pulling string also knotted to tension threads by the knot.

In certain embodiments, the implant delivery device comprises a releasing mechanism allowing a user to pull, or selectively pull, the releasing string, in particularly in order to disengage, interrupt or cease the force transmission between the tension threads and the implant such that the implant cannot be folded any longer by means of the delivery device.

In some embodiments, the implant delivery device further comprises a mechanical reversing device arranged to reverse or amend the direction in which the releasing string extends.

In certain embodiments, the implant delivery device further comprises a balance limiter.

In some embodiments, the knot comprises at least, or exactly, two loops, wherein the first loop is inserted into the second loop and can be pulled out of the second loop upon or by pulling the pulling string.

In certain embodiments, the knot is embodied or knotted as shown in FIG. 7.

In certain embodiments, the set of tension threads comprises at least or exactly three tension threads each of which is preferably wound around at least parts of the implants periphery on at least two heights or longitudinal levels of the implant.

In some embodiments, the implant comprises a first guiding element and a second guiding element. The tension threads are each guided through or along at least sections of both the first and the second guiding elements.

In certain embodiments, at least one of the first guiding element and the second guiding element are hollow rings or channels that are preferably partly open in a cross section thereof.

In certain embodiments of the implantation device, the tensioning device includes at least one pulling string (or thread or wire or the like). The pulling string is arranged and/or provided in such a way that it may indirectly or directly apply a tension on the implant for altering the shape of the implant by the tension thread if the pulling string is pulled or activated by an operator (e. g., by the surgeon).

In certain embodiments of the implantation device, the pulling device is a pulling string.

In certain embodiments, the pulling string is arranged and/or provided such that it may interact with the tension thread in order to transfer force or tension.

In some embodiments of the implantation device, the pulling string and the tension thread are intricate with each other at at least one site.

In some embodiments, the term “releasing mechanism or device” relates to a part of the implantation device for releasing the tension tread(s) from the implant, or the tension applied by the tension threads onto the implant, by unknotting the knot. The releasing device may be arranged to be operated by the surgeon.

In certain embodiments a first string is connected to a multitude of tension threads, for example to—at least or exactly—three or six tension threads.

In some embodiments, none of the tension threads is directly connected to the tensioning device of the implant delivery device, which may be a catheter, for altering a shape of the foldable and/or unfoldable implant. Rather, they are in direct contact with the first string. It is via the first string that they are in indirect contact with the tensioning device.

In certain embodiments, the methods encompasse releasing the knot by pulling the pulling string. In some of these embodiments the tension thread may then be withdrawn from the implant, e. g. by the tensioning device or the surgeon himself.

In certain embodiments, the releasing device is a wire or a thread (or a multitude thereof, respectively).

In certain embodiments, the releasing or separating device may be separated from the implantation device.

In some embodiments of the implantation device, the releasing device is not a cutting device for cutting through the tension thread, and it does not comprise one.

In certain embodiments, the releasing device exerts a tension on the knot via the releasing string substantially or exclusively in a longitudinal direction of the shaft.

In some embodiments, the releasing device enables a transition from the knotted state into the release or unknotted state.

In certain embodiments of the implantation device, said releasing device is arranged such that it enables a transition from the knotted state into the release or non-knotted sate independently from an operation of the tensioning device.

In certain embodiments, the set of tension threads comprises a self-balancing design. For more details regarding the idea of a self-balancing design it is referred to WO 2011063972 A8. See, in particular, FIGS. 2 and 2A thereof. The entire respective content of WO 2011063972 A8 is incorporated herewith by reference.

In some embodiments, the shaft of the implant delivery device is arranged within the center of the implant and/or of the valve at all times.

In certain embodiments, the implant is evenly folded or unfolded by the implant delivery device along its entire length (or longitudinal direction or extension).

Among the advantages achievable with some embodiments is the opportunity of releasing threads from the implant by the releasing string that is arranged for ceasing the stated in which the thread(s) are knotted.

Further, in certain embodiments, the knot allows for a safe but temporary connection between the implantation device, and/or the implant, with the tension threads. At the same time, since the knot may be released after implantation, in some embodiments the present invention allows for an easy removal of the threads from the implant just by opening the knot and by pulling the thread out of the implantation device. In particular, for removing the threads from the implant or from the implantation device, no thread has to be unclamped or even cut. This contributes to a safe handling of the implant upon implantation since every device, such as a cutter, might fail, whereas in the absence of devices such a cutter with the present invention there are less devices that might fail. Also, providing a reliable mechanism such as a cutter always requires observing tolerances in the production process of the implantation device. In contrast, with the solution, less tolerances are to be observed since the knot is not a technical device which function relates on technical tolerances.

Further, in some embodiments, the knot allows for a very easy release of the tension threads.

In certain embodiments, in contrast to cutting, for example, knotting does not require the use of tension threads that provide sufficient resistance to the cutter blade. Rather, for knotting any tension thread will do, in particular also the very flexible ones which provide additional advantages by themselves. Among those advantages, a flexible tension thread may be withdrawn from the implant once it has been release without unintentionally crimping or folding the implant again (because of the resistance between the tension thread and the implant) that can be observed when a stiff(er) tension thread is withdrawn from the implant.

In some embodiments, the knot suggested in FIG. 7 is designed in a way such that the tension thread's ends are bent at a minimum. This has the advantage that the ends of the tension threads are crinkled as little as possible so that they can be easily withdrawn through the apertures of both the implant and the delivery device, see, e. g. FIGS. 56 and 60.

Also, the solution according to certain embodiments which is based on a knot allows using implants comprising tensions threads connected by a knot with all kinds of delivery devices. In particular, the features of the tension threads that come along with the implant do not have to match with a cutter or a clamping device already arranged on the delivery device since the cutter or the clamping device will simply not be used.

If, as contemplated in particular embodiments, one particular tension thread is wound around several sections of the implant, whereas the sections are at different longitudinal heights of the implant, and if both ends of that tension thread are tightened in the knot, then the crimping of the implant may be carried out in a very smooth and easy manner since the tension threads are pulled from both ends. At the same time, the crimping force is applied to the implant in a very homogeneous manner resulting in a very homogeneous folding.

Also, in some embodiments, using a knot instead of a clamping device, a cutter or the like advantageously allows to build a delivery device which is smaller (e. g., in diameter) than prior art devices comprises such a releasing device (i. e. cutter, clamp, and the like).

Furthermore, in certain embodiments, using a knot having two loops as disclosed supra and infra means very little slippage which makes the knot a particularly safe connection.

In certain embodiments, the knot is configured such that it can not be released or opened upon pulling the pulling string, for example at least or solely by pulling in a particular, determined direction.

In some exemplary embodiments according to the present invention, the knot may be tightened and/or maintained knotted by pulling the pulling string and/or applying a tension thereof.

In certain exemplary embodiments according to the present invention, the pulling string and the releasing string are distinct parts of the same string, for example two strings arranged or connected to each other, or constitute the same string.

In some exemplary embodiments, the knot is formed by a string being both a releasing and a pulling string, the one end of which may be pulled for folding the implant and the other end of which may be pulled to release the knot and/or in particular to unfold the implant.

In some embodiments according to the present invention, the releasing string is knotted to the tension threads without additional device or element, for example without strings and/or wire and/or posts, in particular without one or more elongated and/or rigid element, for retaining the knot.

In certain embodiments according to the present invention, the knot may be released from the at least one tension thread without cutting the pulling and/or releasing string and/or without sliding at least one open end of the string through one sling or loop of a tension thread.

In some embodiments, the catheter or implant delivery device for folding or unfolding at least one medical implant by means of at least one tension thread comprises at least a handle assembly.

In certain embodiments, the handle assembly comprises a drum for winding the tension thread thereon by rotating the drum.

In some embodiments, the handle assembly further comprises a knob to be rotated—or being arranged to be rotatable relative to another section of the handle assembly—by a user of the handle assembly in order to fold or unfold the medical implant by tightening or winding the tension thread or by releasing or unwinding the tension thread.

In certain embodiments, the knob is arranged with or interconnected with the drum such that the drum is rotated when the knob is rotated.

In some embodiments, the handle assembly further comprises a displacement limiter for limiting the length or displacement by which the tension thread may be at least one of wound onto or unwound from the drum by rotating the knob.

In certain embodiments, the handle assembly further comprises a force limiter for limiting the maximum force or tension that may be applied or is applicable to the tension thread or to the drum by rotating the knob.

In some embodiments, the handle assembly further comprises a brake frame assembly comprising at least one brake element and at least one spring arranged to act on the brake element such that the brake elements contact one surface of the rear knob.

In certain embodiments, the handle assembly's knob comprises a gear pattern or teeth, e. g. on an inner rim of the knob. In these embodiments, the force limiter comprises or consists of a first ring element, e. g. a rush gear, comprising a gear pattern or teeth matching or corresponding to the gear pattern or teeth of the knob. Further, the force limiter comprises at least one spring element arranged for pressing the first ring element against the knob in a manner such that when a user rotates the knob, in an assembled state of the handle assembly the first ring element is also rotated because of the interaction between the gear pattern or teeth of the knob on the one side and the gear pattern or teeth of the first ring element on the other side.

In some embodiments, the handle assembly's first ring element comprises teeth on an inner surface thereof.

In certain embodiments, the force limiter further comprises a second ring element, e. g. a clutch stopper or a drive wheel. In these embodiments, the spring element is interposed between the first ring element and the second ring element and has contact to both of them.

In some embodiments, one of the first and the second ring element comprises protrusions, and the other one comprises or receptions arranged for receiving the protrusions so as to establish at least one of a form fit and a force disclosure between the first and the second ring elements.

In certain embodiments, some or all of the receptions and the protrusions, respectively, are each arranged at on lower surface of the first ring element and on the upper surface of the second ring element.

In some embodiments, the force limiter further comprises an internal retaining ring attached within the inner lumen of the knob.

In certain embodiments, the drum and the knob are interconnected by a rush gear. The rush gear is arranged to rotated inside—and preferably in engagement with—a gear stopper. The gear stopper, which is preferably arrange inside the rear knob but preferably not fixed or interconnected to the rear knob resulting in that the gear stopper and the rear knob can rotate independently from each other, is moved along or by means of a gear pattern or teeth when being rotated. The rush gear is interconnected to the drum or to part of it such that a rotation of the rush gear results in a rotation of the drum. The displacement limiter comprises or consists of a ring-shaped or tube-shaped element—e.g. a gear stopper—having an inner surface. The inner surface comprises at least one of a second section having an inner surface different to the inner surface of the first section or a radial width (being the distance between the outer surface of the section and the inner surface thereof) smaller than that of the first section, and a third section having an inner surface different to the inner surface of the first section or a radial width smaller than that of the first section.

In some embodiments, at least one of the second section and the third section does not comprising teeth or a gear pattern.

In certain embodiments, at least one of the second section and the third section is arranged in contact with the first section. Alternatively, at least one of them is arranged adjacent to the first section.

In some embodiments, the ring-shaped or tube-shaped element also comprises at least a fourth section on its inner surface. Preferably, the fourth section does not comprise teeth. The fourth section preferably does not comprise teeth or a gear pattern. The fourth section is separated or delimited from at least one of the first or second section by an inclination, an edge, a stop or a protrusion configured to prevent the rush gear to be rotated further towards to or onto the fourth section.

In certain some embodiments, the inner surface of at least one of the second section and the third section has a radial distance to the center of the ring-shaped or tube-shaped element that is larger than a radial distance between the tips of one, some, or the majority of the teeth and the center of the ring-shaped element.

In some embodiments, the ring-shaped or tube-shaped element comprises at least a first protrusion arranged to interfere with a second protrusion of the casing assembly or any other element of the handle assembly so as to limit the rotation of the rush gear within the ring-shaped or tube-shaped element.

In certain embodiments, the at least one first protrusion is arranged so as to protrude into an inner lumen of the ring-shaped or tube-shaped element.

In some embodiments, the at least one first protrusion is arranged between the second and the third sections or at the fourth section or opposite the first section of the ring-shaped or tube-shaped element or has its base at one of the aforementioned sites.

In certain embodiments, the second section has at least one of a length, width (in a radial direction) and inclination such that the rush gear may be positioned inside the second section such that at least one tooth of the rush gear is engaged with at least one tooth of the teeth of the first section while at least one tooth of the rush gear is at the same time in contact with the inclination, the edge, stop or protrusion delimiting the second section from the fourth section or arranged within the second section.

In some embodiments, the third section has at least one of a length, width (in a radial direction) and inclination such that the rush gear may be positioned inside it such that one tooth of the rush gear is only half-engaged with at least one tooth of the teeth of the first section while other teeth of the rush gear are at the same time in contact with the inclination, the edge, stop or protrusion delimiting the third section from the fourth section or arranged within the second section. “Half-engaged” within the meaning of the present embodiments may be such that rotating the drum in one direction may not result into rotating the gear stopper as well, whereas rotating the drum in the opposite direction would necessarily result in an functional engagement of the teeth of the drum with the teeth of the first section of the gear stopper again. “Half-engaged” may be understood such that one tooth of the drum and the last tooth of the first section 1911 contact each other temporarily but slip over each over if the rush gear 16 is rotated in a first direction whereas the rush gear 16 and the gear stopper 19 get into normal teeth engagement if the rush gear 16 is rotated in the counter-direction.

In certain embodiments, the drum is simultaneously engaged (or at least half-engaged as defined above) both to the rush gear and the gear stopper, or is in contact with both, preferably always.

In some embodiments, the brake frame assembly is configured and arranged to brake a rotation of the rear knob or to prevent the unintended rotation thereof.

In certain embodiments, the at least one brake element is arranged on a frame of the brake frame assembly such that the brake element may pivot with respect to the frame.

In some embodiments, the brake frame assembly is arranged inside the rear knob.

In certain embodiments, the brake frame assembly has two brake elements arranged opposite to each other.

In some embodiments according to the present invention, unfolding is to be understood as increasing a diameter of the implant or as allowing the implant to increase in diameter by, for example a shape memory capability plus a sufficient release of the tension thread that would otherwise hinder the implant from returning into its original shape.

To “unfold” may, hence, in some embodiments be understood as actively releasing the tension acting on tension threads biasing the implant.

In some embodiments, the shaft may comprise individual shaft fibers as it is disclosed in WO 2012/084178, the respective disclosure is expressly incorporated herein by reference thereto. In particular embodiments, some or all features mentioned herein with respect to the shaft may also be comprised by some or all of the individual shaft fibers.

In some embodiments, one achievable advantage is that the force applied on the tension threads by which the implant is folded or unfolded may not be exceeded. Hence, the risk of a tension thread rupture because of undue operation of the handle assembly is minimized or even completely avoided because of the force limiter. In fact, the tension the tension threads have to stand upon winding them onto the drum is limited to a pre-set maximum value.

Also, in particular embodiments, the tension threads will stretch under tension. By using the force limiter, one can take up the slack caused by this stretching, thereby ensuring complete folding.

Also, in certain embodiments, the force limiter is designed as a component allowing patency because of its overall ring or tube shape. Hence, the force limiter can be designed to fit into very little space while allow the room it takes to used for other purposes as well. For example, a guide wire may be advanced through the inner lumen established by the elements forming the force limiter.

In some embodiments, one achievable advantage is that the implant must not be overly unfolded. In fact, because of the displacement limiter the tension threads cannot be released more than it was pre-set as the length by which the tension threads may be unwind is limited to a pre-set value by means of the displacement limiter. That way, the tension threads will not be over-released beyond the maximum diameter of the stent. Over-releasing causes the stent/valve to bounce up and down in the blood flow of the beating heart making positioning difficult. Over-releasing also poses a risk where the strings may come off the stent/valve. This may be advantageously avoided by the present invention.

In certain embodiments of the present invention, the force limiter, the knob and/or the first ring element of the force limiter, in particular the inner rim of the knob, for example the gear pattern or teeth matching or corresponding to the gear pattern or teeth of the first ring element, do not comprise deformable projections or deformable teeth.

In some embodiments of the present invention, the spring element of the force limiter comprises at least two or more springs or two or more any other elastic elements.

In certain embodiments of the present invention, the at least two or more springs or two or more any other elastic elements are arranged, formed and/or disposed, in particular uniformly distributed, in or onto the first and/or the second ring element, in particular on a peripherical ring or portion of the first and/or the second ring element.

In some embodiments of the present invention, the first and/or the second ring element is not configured, designed, formed and/or shaped as a plate or disk.

In certain embodiments of the present invention, the ring elements are not connected and/or intended to be connectable to each other through a central shaft and/or the spring element is not supported and/or arranged or disposed around a central shaft connecting the ring elements.

In certain embodiments according to the present invention, one achievable advantage is that the force applied to the force limiter may be distributed homogeneously through and/or within the spring element.

In some embodiments according to the present invention, one achievable advantage is that a tilting movement of the first and/or the second element, in particular relating to a longitudinal direction of the handle assembly and/or to a direction going through the centers of both ring elements, may advantageously be reduced or even avoided.

In particular embodiments a sliding of the first and/or of the second ring element, in particular in a direction perpendicular to the longitudinal direction of the handle assembly and/or to a direction going through the centers of both ring elements, may be advantageously prevented or avoided.

In certain embodiments according to the present invention, one achievable advantage is that the spring constant of the individual springs or corresponding suitable elastic elements can advantageously be reduced compared to or may be lower than the spring constant of a spring element with a single spring (or corresponding single suitable elastic element) of similar properties.

In some embodiments according to the present invention, the force limiter may be of light-weight type, for example in embodiments without central shaft joining the ring elements.

In some embodiments according to the present invention, the handle assembly does not comprise an indicator for indicating the position of an actuation element, for example of a tension thread, in particular no indicator to be aligned with some markings of the handle assembly.

In certain embodiments according to the present invention, the displacement limiter is not designed and/or does not comprise a Geneva-gear mechanism or a Maltese-cross, in particular not of the circumscribed type.

In some embodiments according to the present invention, the displacement limiter does not comprise a band, in particular of a predetermined length, intended and/or configured to be wound around an axis or spool configured to rotate when the drum is rotated and/or during the winding/unwinding of the tension thread.

In certain embodiments according to the present invention, the brake assembly is not configured and/or arranged to brake and/or prevent rotation of the knob in a single direction only and/or does not comprise a device or assembly for releasing, at least temporarily and/or reversibly, the braking force of the brake element applied on the surface of the knob.

In some embodiments according to the present invention, the brake element does not contact the drum and/or may be urged over the outer periphery or circumference of the brake assembly.

In certain embodiments according to the present invention, the surface of the knob being in contact, in particular permanently, with the brake element is an inner surface of the knob.

In some embodiments according to the present invention, the brake element is not and/or does not comprise a detent and/or ratchet and/or may not be actuated by a user and/or its braking force or intensity may not be changed during use of the handle assembly, in particular by a user.

In certain embodiments according to the present invention, the surface of the brake element contacting the knob and/or the corresponding knob surface does not present or comprise teeth.

In some embodiments, the handle assembly comprises at least one of a force limiter, a displacement limiter and a brake frame assembly.

In some embodiments, the implant comprises at least two heart valve leaflets.

In certain embodiments, the implant comprises at least one crown piece (also referred to as ‘triangle’ hereinafter) interconnected to the leaflets.

In some embodiments, the crown piece is preferably intended to be interconnected, directly or indirectly, for example sewed, to a frame (also referred to as the support or the body of the implant or a stent by way of example hereinafter).

In certain embodiments, the implant comprises a top cuff and a bottom cuff.

In some embodiments, the crown piece, the top cuff and the bottom cuff are each rings or ring-shaped, and both the top cuff and the bottom cuff are interconnected with the crown piece.

In certain embodiments, the implant has a frame or support or stent comprising at least or exactly one first guiding structure for guiding or comprising at least one tension thread for folding and/or unfolding the frame around or along the frame, support or stent, for example at an outside or an circumference thereof.

In some embodiments, the frame, support or stent comprises at least or exactly one second guiding structure different from the first guiding structure also for guiding or comprising at least one tension thread for folding and/or unfolding the implant around or along the frame, for example at an outside or an circumference thereof.

In certain embodiments, the frame further comprises at least two, preferably three, posts. The posts are arranged between the first and the second guiding structure such that they interconnect the first and the second guiding structure with each other and/or maintain the distance between them.

In some embodiments, at least one of the top cuff and the bottom cuff is formed from a stripe (or strap) or comprises a stripe (or strap, e.g. a thin band that is longer than broad). The stripe is (in its flat state) curved along its length, preferably or at least in a plane of its width.

In certain embodiments, the top cuff has a width that is smaller than a width of the bottom cuff.

In certain embodiments, the ‘width’ refers to an average width of the stripe.

In some embodiments, the top cuff and the bottom cuff are equally long (or almost equally long).

In particular embodiments, the top cuff is arranged closer to the leaflets than the bottom cuff.

In some embodiments, all leaflets are sewed to the crown piece by means of one or exactly one suture or stitch.

In particular embodiments, a suture is a filament or a thread or yarn. In these embodiments, ‘one suture’ means one filament (or thread or yarn) used for sewing two pieces together. In these embodiments, no second filament is used and, in consequence, only one knot is required.

In some embodiments, both the top cuff and the bottom cuff are sewed to the crown piece by means of one or exactly one suture.

In particular embodiments, the crown piece is sewed to the posts, preferably using (or via or through) through holes or eyelets of the posts, preferably through at least three or four, preferably consecutive through holes, preferably by means of tabs being small extensions of the crown piece or by leaving out the tabs, preferably by means of one or exactly one suture per post.

In some embodiments, the suture for interconnecting the crown piece to one post was started from an outer side of that post to an inner side of the post. Preferably, the single knot that interconnects both ends of the suture is arranged on an outside of the post.

In particular embodiments, the posts are arranged inside a circle or an area circumscribed by the crown piece.

In some embodiments, the posts are arranged outside the circle or the area circumscribed by at least one of the top cuff and the bottom cuff.

In particular embodiments, at least one of the first and the second guiding structure comprises or consists of bars (can be struts instead) that are interconnected to each other so as to form a zig-zag pattern or an undulating or meandering pattern. Neighbouring or adjacent or contacting bars are provided for moving relative to each other or for changing a distance or an angle between them (or between sections thereof, respectively) upon folding or unfolding of the implant or frame. The bars are preferably arranged outside the circle or the area circumscribed by at least one of the top cuff and the bottom cuff. In preferred embodiments the bars are covered on their inner side (being the side towards the inner space of the frame or implant) at least in part(s) by at least one of the top cuff and the bottom cuff.

In some embodiments, the leaflets have a first tab and a second tab arranged at opposite ends of the respective leaflet. The tabs are sewed onto the post of the frame.

In certain embodiments, the tabs extend from the body of the leaflet.

In particular embodiments, tabs of two adjacent leaflets are sewed to one post in an overlapping manner.

In certain embodiments, the tab of a first leaflet is or was sewed onto a post first, and wherein the tab of a second leaflet was sewed onto both the tab of a first leaflet and the post the tab of the first leaflet had been sewed to, all in one running stitch or with one suture.

In some embodiments, the medical implant comprises exactly three posts.

In certain embodiments, the heart valve comprises exactly three leaflets.

In particular embodiments, the implant is a heart or cardiac valve assembly.

In certain embodiments, the crown piece may have up to three sections that are triangle in shape (at least once the crown piece's free ends are put together such that the crown piece forms a ring).

In particular embodiments, the frame (or support or body) of the implant is made of or comprises a metal or a shape memory material.

In certain embodiments, the top cuff and the bottom cuff are originally separate pieces, directly or indirectly interconnected with each other by sewing.

In some embodiments, the crown piece may have sections ending in a tip of a triangle section of the crown piece or in a tab extending from the tip of the triangle, the tab having a free end (before being fixed to, for example, the leaflets).

In certain embodiments, the crown piece is interposed between the top cuff and the bottom cuff.

In certain embodiments, at least one of the top cuff and the bottom cuff is made from porcine pericardium or is a fabric.

In some embodiments, the leaflets are interconnected with, preferably glued or sewed to, the crown piece.

In particular embodiments, the frame, support or stent has features as described in WO 2011/063972 A1 or WO 2009/109348 A1 with respect to the implant. The respective disclosures of WO 2011/063972 A1 and WO 2009/109348 A1 are incorporated in its entirety into the present specification by reference.

In certain embodiments, the implant is configured to have or has tension applied to it by using at least one tension thread. The tension is preferably controlled by altering a length of the pulling device by which it extends out of the interior of the shaft or an implantation device or sections thereof.

In certain embodiments, at least one of the heart valve and the frame comprises exclusively (one or more) materials that are not magnetic, ferromagnetic, or both.

In some embodiments, at least one of the heart valve and the frame does not comprise metal or any metal alloy.

In certain embodiments, eat least one of the posts has at least two openings through which tension threads are guided from an inside or inner space of the implant to an outside of the implant and back from the outside to the inside. The tension threads are guided to the outside through a first opening of a first one of the posts and back to the inside—or vice versa—through any second first opening of any second post, the first opening being different from the second opening, and the first post being different from the second post.

In particular embodiments, the crown piece is interconnected to the frame of a medical implant or a heart valve assembly.

In certain embodiments, both the top cuff and the bottom cuff are interconnected to bars of a guiding structure of the frame, preferably by sewing, preferably in direct contact to the bars.

According to some embodiments, the top cuff and the bottom cuff may have different widths. If the top cuff and the bottom cuff is now everted to the outside face of the bars both at an upper end and an lower end of the bars by an equal distance (the equal distance is usually equal since it takes the same amount of material or overlap to secure the cuffs on the tips of both the upper parts and the lower parts of the bars), a suture interconnecting the two cuffs (plus the crown piece) will not be positioned in a middle line of the bars. That way, the suture will not be damaged by the bars in a folded state of the implant in which the middle of the bars will usually have to face the highest pressure. At the same token, the suture does not contribute to applying pressure on the leaflets starting about the height of the bars of the guiding structure as the suture will not contribute to narrowing the space about the middle line of the bars due to its position beyond the middle line.

Further, in certain embodiments, sewing parts by just one suture may contribute in avoiding knots which in turn require space and are prone to damaging neighboring structures such as leaflets.

If, as in particular embodiments, the inner side of the top cuff is interconnected to the outer side of the bottom cuff, the resulting geometrical shape will show a profile that extends with a middle portion thereof into the inner space it circumscribes. In a front cut the geometrical shape may be called concave. That shape may fit best to the also concave shape of the bent bars and the resulting concave shape of the guiding structure which is another advantage.

In some embodiments, the implant is or comprises a heart valve assembly comprising a frame and a heart valve.

In certain embodiments, the frame supports the heart valve or is interconnected thereto, preferably by sewing or sewing alone.

The interconnecting tissue or parts thereof, respectively, is interconnected to at least one of the guiding structures such that it covers the guiding structure or parts thereof at an inner circumference of the guiding structure and such that it also covers both an upper part and a lower part of the outer circumference of the guiding structure.

In certain embodiments, at least one of the first and the second guiding structure comprises bars or consist of bars. The bars have top portions and bottom portions (herein, ‘top’ and ‘bottom’, like ‘upper’ and ‘lower’, refer to the orientation of the drawings or to the main orientation of the heart valve assembly or to the main flow through direction of the heart valve assembly in use). The interconnecting tissue or parts thereof are interconnected to the bars such that the interconnecting tissue covers the bars at an inner circumference of the guiding structure. It also covers the bars at both an upper part and a lower part of the outer circumference of the guiding structure.

In some embodiments, the interconnecting tissue comprises or consists of at least one crown piece interconnected to the leaflets, a top cuff and a bottom cuff each of which is ring-shaped, and both the top cuff and the bottom cuff are interconnected with the crown piece.

In certain embodiments, at least one of the top cuff and the bottom cuff is formed from a stripe or comprises a stripe, wherein the stripe is curved along its length.

In some embodiments, the top cuff has a width that is smaller than the width of the bottom cuff.

In certain embodiments, the crown piece or an section thereof is interposed between the top cuff and the bottom cuff.

In some embodiments, the frame is foldable and/or unfoldable.

In certain embodiments, bars of at least one of the first and the second guiding structure are interconnected to each other so as to form a zig-zag pattern or an undulating or meandering pattern. The bars are preferably arranged outside the circle or the area circumscribed by at least one of the interconnecting tissue, the top cuff and the bottom cuff.

In particular embodiments, the heart valve assembly or the frame may be folded or unfolded upon implantation by using one or several tension threads or filaments wound around the assembly.

In certain embodiments, folding the implant means reducing the diameter of the implant. Folding also covers “re-folding” of an once expanded implant.

In some embodiments, unfolding should be understood as increasing the diameter of the implant, or as expanding.