DE202017104793U1 - Charging system for heart valve prostheses - Google Patents

Abstract

A loading system (10) for releasably holding a heart valve prosthesis (100) on a catheter tube (20), the loading system (10) comprising: - at least one fixed receiving element (12) having at least one groove-shaped recess (15, 16) for receiving in each case at least one distal stent-end element (114) of a heart valve prosthesis (100), and which has a size and shape that is adapted to the respective at least one distal stent-end element (114), wherein the at least one fixed receiving element (12) is axially fixed relative to a catheter tube (20) carrying the heart valve prosthesis (100); and at least one movable receiving element (14) having at least one groove-shaped recess (17), which is designed to receive in each case at least one distal stent-end element (114) of a heart valve prosthesis (100) and which has a size and shape, which is adapted to the respective at least one distal stent-end element (114), wherein the at least one movable receiving element (14) is axially movable relative to a catheter tube (20) carrying the heart valve prosthesis (100).

Description

The present invention relates to a charging system and a release system for a heart valve prosthesis to be used therewith.

Relief systems for heart valve prosthesis are - just as, of course, the heart valve prostheses themselves - vital medical instruments, which are always used when a native heart valve with this replacing or supporting heart valve must be treated.

Heart valve replacement is necessary if the native heart valve is damaged, malfunctioning or not working. In the heart, heart or "aortic" valves maintain blood flow in one direction by opening and closing on each side, depending on the pressure difference.

The aortic valve may be affected by a variety of diseases and therefore necessitate valvular replacement, meaning that the aortic valve of a patient is replaced with another valve. The flap may either leak, i. become regurgitant or deficient, resulting in incompetence of the aortic valve and blood returning passively to the heart in the wrong direction. Furthermore, the flap can be partially closed, i. become stenotic, which results in the valve not fully opening, thus obstructing the blood flow from the heart. The two states often coexist.

There are two basic types of artificial heart valves, i. mechanical valves and tissue valves. Tissue heart valves usually consist of animal tissue, either animal heart tissue or animal pericardial tissue, which is treated to prevent rejection and calcification. While mechanical valves are generally designed to outlive the patient, they have the disadvantage that due to their material there is an increased risk of blood clots forming due to a constant anticoagulant therapy that makes the patient more susceptible to bleeding , can be prevented. Mechanical heart valves are generally made entirely of synthetic or non-biological materials, while tissue heart valves (or bioprosthetic heart valves) are made of synthetic and biological materials. Bioprosthetic heart valves may be either xenografts derived from a species other than the recipient, or homografts, which are donor flaps taken from the same species as the recipient. In general, the artificial valves include expandable stent systems which can be introduced into the vessel in a compressed state and expand by removal of compressive constructions.

An aortic valve replacement traditionally requires a median sternotomy, and thus open heart surgery, which places a heavy burden on the patient being treated: the sternum is sawn, and after opening the pericardium, the patient is connected to a cardiopulmonary bypass device. Once the patient is connected to the bypass device, the patient's diseased aortic valve is removed and a mechanical or tissue valve replaced. In addition to the physical strain associated with this surgery, there is also a risk of death or serious complications from open heart surgery, particularly depending on the patient's state of health and age.

However, recently, valves have been developed that can be implanted with a catheter or delivery system without open heart surgery, and implantation of the prosthesis can be accomplished either retrograde, i. against normal blood flow, or antegrade, i. with the blood flow, done.

The international patent application WO 2008/070797 discloses a system and method for transapical delivery of an annulus self-expanding valve. The system disclosed therein comprises a catheter assembly having an outer sheath, an elongate push tube, and a central tubular tube. At the distal end of the central tubular tube an atraumatic tip is provided; when loaded, the prosthesis is carried next to the tip on the central tubular tube and compressed by the sheath. Upon retraction of the sheath, the distal end of the prosthesis, ie the end closest to the tip, is released and the prosthesis is allowed to expand. Subsequently, the sheath is fully retracted to fully release the prosthesis, so that in the case of a self-expanding prosthesis, the prosthesis can then fully expand or expand using a balloon.

Disclosed in analogy WO 2007/098232 a self-expanding prosthesis delivery device, wherein the device comprises a split sheath by means of which the prosthesis can be inserted in several steps.

WO2008 / 138584 A1 discloses a catheter delivery system with a self-expanding heart valve stent. The introduction system of WO 2008/138584 A1 comprises a handle for manipulating a catheter tip of the system, wherein the handle comprises means comprising a prescribes a predetermined order of steps so that each subsequent step is prevented until the previous step is completed.

Despite the variety of different delivery and loading systems and techniques known in the art, precise release with the ability to still move the prosthesis after its partial introduction remains a critical step and is compatible with currently available systems and methods difficult to achieve. Moreover, a major drawback of presently-used self-expanding valve deployment systems is that the proximal end of the prosthesis, which must first be released, expands after insertion, thus forming a "parachute" that obstructs blood flow. Due to this fact, the operator, e.g. a surgeon, work under time pressure and use the prosthesis quickly, so as not to interrupt the normal blood flow.

Against this background, it is an object of the invention to provide an improved delivery system which can prevent obstruction of blood flow and thus impairment of natural cardiac function, while at the same time the delivery system should be easy to handle and accurate placement and possibly also Correction of a misplaced prosthesis allows.

According to the invention this object is achieved with a charging and a release system, as described in detail in the claims.

• - zumindest ein fixiertes Aufnahmeelement, das zumindest eine nutförmige Aussparung aufweist, die zur Aufnahme von jeweils zumindest einem distalen Stentende-Element einer Herzklappenprothese ausgebildet ist, und die eine Größe und Form aufweist, die dem jeweils zumindest einen distalen Stentende-Element angepasst ist, wobei das zumindest eine fixierte Aufnahmeelement gegenüber einem die Herzklappenprothese tragenden Katheterrohr axial fixiert ist; und
• - zumindest ein bewegliches Aufnahmeelement, das zumindest eine nutförmige Aussparung aufweist, die zur Aufnahme von jeweils zumindest einem distalen Stentende-Element einer Herzklappenprothese ausgebildet ist, und die eine Größe und Form aufweist, die dem jeweils zumindest einen distalen Stentende-Element angepasst ist, wobei das zumindest eine bewegliche Aufnahmeelement gegenüber einem die Herzklappenprothese tragenden Katheterrohr axial beweglich ist.

More particularly, the present invention provides a loading system for releasably holding a prosthetic heart valve on a catheter tube, the loading system comprising:

• at least one fixed receiving element having at least one groove-shaped recess, which is designed to receive in each case at least one distal stent-end element of a heart valve prosthesis, and which has a size and shape which is adapted to the at least one distal stent-end element the at least one fixed receiving element is fixed axially relative to a catheter tube carrying the heart valve prosthesis; and
• - At least one movable receiving element having at least one groove-shaped recess which is adapted to receive each at least one distal stent-end element of a heart valve prosthesis, and having a size and shape which is adapted to each at least one distal stent-end element, wherein the at least one movable receiving element is axially movable relative to a catheter tube carrying the heart valve prosthesis.

The charging system according to the invention offers the advantage that a charged heart valve prosthesis can be aligned directly and simply at the site of implantation and before release. Heart valve prostheses include, as already mentioned, usually a stent framework and an attached heart valve. For insertion into a heart to be treated, the heart valve prosthesis is releasably fixed to the insertion catheter via its stent framework or via its distal and proximal end.

Due to the special construction of the charging system according to the invention, it is now possible to fix a heart valve prosthesis which has stent-end elements at its distal end, via which it can be releasably connected to the charging system, with one or two or more of its stent-end elements Receive receiving element, and at the same time, for example, with one or two or more of the other stent-end elements to receive in the movable receiving element. After introduction and positioning on the flap to be treated, the stent element of the heart valve prosthesis or the heart valve prosthesis can be deflected by axial displacement of the movable receiving element relative to the catheter tube carrying the heart valve prosthesis and aligned exactly in the heart.

The object underlying the invention is completely solved in this way and by a charging system according to the invention exhibiting release system.

In the charging system according to the invention is preferred according to an embodiment, if it between 1 and 5, especially 1 . 2 . 3 . 4 or 5 fixed receiving elements, preferably 1, and / or between 1 and 3 , especially, 1 . 2 or 3 , in particular 1, movable receiving elements. The respective receiving elements can each have one or more groove-shaped recesses.

According to a further embodiment charging system according to claim 1 or 2 , characterized in that the fixed receiving elements between 1 and 5 Has groove-shaped recesses and / or that the movable receiving element between 1 and 3 having groove-shaped recesses.

In particular, it is preferred if in the charging system according to the invention, the fixed Receiving element two groove-shaped recesses and the movable receiving element 1 having groove-shaped recess.

It will be apparent to those skilled in the art, based on the present disclosure, that the number of groove-shaped recesses of the receiving elements will depend on the number of distal stent-end elements of the heart valve prosthesis to be inserted, which are preferably all received in receiving elements.

Furthermore, it will be clear to the person skilled in the art that he can vary the number of groove-shaped recesses to be provided in the fixed receiving element and the groove-shaped recesses to be provided in the movable receiving element, in order to maximize the ease and simplicity of the heart valve prosthesis to be used - and for any anatomical conditions that may be present manageable alignment and ultimately release.

The distal stent-end elements are thereby removably received in the receiving elements in the charging system according to the invention, and are during the insertion, positioning and alignment of the prosthetic heart valve by retaining means, eg. A retraction sleeve, first fixed in the receiving elements, but by removing the retaining means of the Recording elements released. This process, or this property with respect to the receiving elements, means "detachable" in the present case.

The heart valve prosthesis is preferably self-expandable, i. it consists of or comprises a stent framework made of a material with shape-memory property, to which stent framework the replacement flap is attached.

According to a preferred embodiment - based on the number of distal stent end elements of the heart valve prosthesis - more distal stent end elements are received in a fixed receiving element as in a movable receiving element.

In a preferred embodiment of the charging system according to the invention it is provided that it has two groove-shaped recesses in a fixed receiving element and a groove-shaped recess in a movable receiving element.

With this embodiment, in particular heart valve prostheses with 3 distal end-stop elements are simply inserted and positioned so that the distal end of the hereditary prosthesis can be tilted. For this purpose, two stent-end elements are releasably received in two fixed receiving elements and a stent-end element in a movable receiving element.

In one embodiment of the charging system according to the invention is preferred when the groove-shaped recess is substantially T-shaped.

In the present context, "groove-shaped recess" means any receptacle or recess in the charging system otherwise adapted to the shape of the catheter tube, into which a stent-end element of the heart valve prosthesis can be detachably received.

According to a further embodiment of the charging system according to the invention is preferred if the at least one movable receiving element is fixedly connected to a displacement element, which displacement element for axial movement of the receiving element is actuated.

In this case, it is particularly preferred if the displacement element is selected from one of the following: a threaded rod arranged on or in the release catheter, a wire, a tube.

About the fixedly connected to the movable receiving element sliding element is ensured that the movable receiving element targeted and controlled relative to the catheter tube, for example. Proximal, ie towards the user, can be moved, at the same time fixed the / the fixed receiving element (s) relative to the catheter tube remains.

It is provided according to a preferred embodiment, when the movable receiving element by between 0.5 cm and 2 cm in the axial direction (forward and / or back) is displaced.

Accordingly, the present invention also relates to a release system for releasing an expandable heart valve prosthesis, which has a charging system as described above.

• - ein Katheterrohr, das ein Lumen aufweist und das zum Tragen einer selbstexpandierbaren Herzklappenprothese ausgebildet ist;
• - ein wie oben beschriebenes erfindungsgemäßes Ladesystem, das auf dem Katheterrohr angeordnet ist;
• - eine Rückzugshülle, die zum Halten der Herzklappenprothese in einem komprimierten Zustand ausgebildet ist, wobei die Rückzugshülle in Bezug auf die Herzklappenprothese in proximale Richtung verschiebbar ist, um die Herzklappenprothese schrittweise freizusetzen.

In particular, it is preferred if the release system comprises:

• a catheter tube having a lumen and adapted to support a self-expanding heart valve prosthesis;
• - A charging system according to the invention as described above, which is arranged on the catheter tube;
• - A retraction sleeve, which is used to hold the prosthetic heart valve in a compressed State is formed, wherein the retraction sleeve is displaceable in the proximal direction with respect to the heart valve prosthesis, to gradually release the heart valve prosthesis.

As discussed above, with the release system of the present invention it is now possible to properly align, in particular tilt or deflect, a heart valve prosthesis after it has been positioned, but before it is released, by operating the movable receiving element (s). Upon proper alignment, the retraction sheath may be removed and the stent-end elements of the prosthetic heart valve releasably received within the retainers are released.

In the prior art and in the present application, the end of the heart valve prosthesis (or "heart valve") comprising the valve is commonly referred to as the "proximal end", while the end of the heart valve, which is more free of valve material, is referred to as "distal." End "is called.

In contrast, the designation of the ends or end portions of the delivery system as distal or proximal means that the end closer to the operator is the "proximal" end and the other end farther from the operator is the "distal" one "End is. At present and in this application, when the term "proximal" is used in connection with the indication of a direction, i. the "proximal direction" is used, which means the operator-facing direction. If, on the other hand, to describe a direction, we use the term "distal", i. the "distal direction" is the direction that guides or points away from the operator / surgeon / specialist. In addition, when referring to the ends of the parts of the delivery system, the term "proximal end" refers to the end that is attached to the operator, e.g. closest to the surgeon, and the term "distal end" refers to the end opposite the proximal end, which is closer to the patient being treated.

The charging system according to the invention is operated according to a preferred embodiment together with a release system, as shown in the EP 2 529 701 A1 is described, the content of which is hereby expressly incorporated by reference thereto.

The present invention further relates to a combination of a delivery system according to the invention and a heart valve prosthesis.

It is provided according to a preferred embodiment that the heart valve prosthesis a self-expandable, substantially hollow cylindrical stent carrier / stent framework with a plurality of diamond-shaped expandable cells, and with a proximal end and a distal end, which end both a crown with a variety of free tips have at the distal end of the stent carrier at least or exclusively three free tips are provided, each having a T-shaped end, and a fixed to the inner surface of the stent carrier flap is provided.

According to the invention, these free tips with a T-shaped end, which is preferably formed by a T-shaped extension structure, in the present case also referred to as "distal stent-end elements".

According to a preferred embodiment, the heart valve prosthesis has radiopaque markers.

Further, according to a preferred embodiment of the prosthetic heart valve, the T-shaped end of the at least or three exclusive tips is formed by an elongate extension structure having a first wire portion having a first end and a second end, the first wire portion being substantially parallel to the longitudinal axis of the stent carrier, and a second wire portion provided at the second end of the first wire portion perpendicular thereto and having a shape selected from substantially round, oval, oblong rectangular.

Most preferably, the delivery system comprises a prosthetic heart valve as a replacement for a diseased or malfunctioning heart valve of a patient in need of a prosthetic heart valve.

The heart valve prosthesis which can be used together with the loading system or release system according to the invention accordingly preferably comprises an expandable, substantially cylindrical stent carrier with a multiplicity of diamond-shaped expandable cells, and with a proximal end, a proximal section, a middle section, a distal one And a distal end, wherein at the distal end of the stent carrier at least three of the outermost and free corners of the diamond-shaped expandable cells facing in the distal direction have a T-shaped end, the middle portion of the stent carrier carrying radiopaque markers, and wherein the size of the cells in the distal section is greater than the size of the cells in the proximal section. Furthermore, the prosthesis according to the invention comprises a flap with a large number of sails, and a plurality of commissure points, and wherein the flap is mounted on the stent carrier such that the flap forms the inner surface of the stent carrier, further forming a sealing zone in the proximal portion, wherein the inner surface of the cylindrical stent carrier is lined with the flap in that the flap is further fixed in a region between the distal end and the central portion via the commissure points on the stent carrier, and in that the stent carrier has a flap-free portion in a region between the distal end and the middle portion.

This prosthesis is particularly suitable for introduction into the heart via the release system according to the invention. The particular shape of the prosthesis associated with the T-shaped end of the prosthesis allows easy and precise loading of the prosthesis onto / into the delivery system as well as precise release and alignment at the site of interest. Furthermore, with the radiopaque markers, the correct and precise positioning of the prosthesis during release can be easily observed, e.g. by X-ray.

The heart valve prosthesis described herein has the cylindrical shape of the stent carrier at the distal end in the flap free portion of a diameter that is reduced compared to the rest of the cylindrical shape of the stent carrier.

In a preferred embodiment, the heart valve prosthesis described herein comprises bovine pericardium.

In a particular embodiment of the heart valve prosthesis described herein, the cylindrical shape of the stent carrier at the point of fixation of the commissure points of the flap on the stent carrier has the largest diameter compared to the remaining cylindrical shape.

This feature provides for tight attachment of the prosthetic heart valve at the insertion site, where the fixation is of critical importance, and thus prevents the prosthesis from moving away from its location.

• - Bereitstellen einer auf ein Freisetzungssystem geladenen selbstexpandierenden Herzklappenprothese, wobei das Freisetzungssystem ein Katheterrohr mit ein Lumen aufweist, welches Katheterrohr zum Tragen der selbstexpandierbaren Herzklappenprothese ausgebildet ist, ferner ein wie oben beschriebenes erfindungsgemäßes Ladesystem, das auf dem Katheterrohr angeordnet ist, und das zumindest ein fixiertes und zumindest ein bewegliches Aufnahmeelement aufweist, in welche die Stentende-Elemente der Herzklappenprothese lösbar aufgenommen sind, sowie eine Rückzugshülle, die zum Halten der Herzklappenprothese in einem komprimierten Zustand ausgebildet ist, wobei die Rückzugshülle in Bezug auf die Herzklappenprothese in proximale Richtung, d.h. in Richtung des Anwenders, verschiebbar ist,
• - Einbringen und Positionieren der Herzklappenprothese in das Herz des zu behandelnden Patienten,
• - Betätigen der Rückzugshülle zur teilweisen Freisetzung der Herzklappenprothese derart, dass sich sowohl das distale also auch das proximale Ende der Herzklappenprothese noch geschlossen im Ladesystem befindet,
• - Betätigen des beweglichen Aufnahmeelements zum Ausrichten der Herzklappenprothese, und
• - Betätigen der Rückzugshülle zur vollständigen Freisetzung der Herzklappenprothese.

Accordingly, the present invention also relates to a method for introducing a heart valve prosthesis into the heart of a patient, preferably a human patient, comprising the following steps:

• Providing a self-expanding prosthetic heart valve loaded on a release system, wherein the release system comprises a catheter tube having a lumen, which catheter tube is adapted to carry the self-expanding heart valve prosthesis, further comprising a loading system according to the invention as described above, which is arranged on the catheter tube, and which at least one fixed and at least one moveable receiving member into which the stent-end members of the prosthetic heart valve are releasably received, and a withdrawal envelope configured to hold the prosthetic heart valve in a compressed state, the withdrawal envelope being proximal to the prosthetic heart valve, ie, in the direction of the user, is displaceable,
• Introduction and positioning of the heart valve prosthesis in the heart of the patient to be treated,
• Actuating the retraction sleeve for the partial release of the heart valve prosthesis in such a way that both the distal end and also the proximal end of the heart valve prosthesis are still closed in the loading system,
• - Actuation of the movable receiving element for aligning the heart valve prosthesis, and
• - Actuation of the withdrawal envelope for complete release of the heart valve prosthesis.

It will be understood that the features described above and the features to be described below fall both in the particular combinations specified as well as in other combinations or alone within the scope of the present invention.

Further features will become apparent from the description and the preferred embodiments.

Preferred embodiments are shown in the figures and described in more detail below.

• 1 im Längsschnitt eine Ausführungsform eines erfindungsgemäßen Ladesystems, das nicht maßstabsgerecht gezeichnet ist, mit einem schematische gezeichneten Stentende-Element, das das Ladesystem aufgenommen ist;
• 2 das Ladesystem aus 1 im Querschnitt, nicht maßstabsgetreu; und
• 3 eine Darstellung einer beispielhaft mit dem erfindungsgemäßen Ladesystem einzusetzenden Herzklappenprothese; und
• 4 eine Darstellung einer beispielhaft mit dem erfindungsgemäßen Ladesystem einzusetzenden Herzklappenprothese in nicht ausgerichteter Position (A); sowie nach Bewegen des beweglichen Aufnahmeelements (B).
• In den 1 und 2 ist eine nicht-maßstabsgetreue Ausführungsform des erfindungsgemäßen Ladesystems allgemein mit 10 bezeichnet, mit einem fixierten Aufnahmeelement 12 und einem beweglichen Aufnahmeelement 14.

In the figures show:

• 1 a longitudinal section of an embodiment of a charging system according to the invention, which is not drawn to scale, with a schematically drawn stent-end element, which is taken up the charging system;
• 2 the charging system off 1 in cross-section, not to scale; and
• 3 a representation of an example to be used with the charging system according to the invention heart valve prosthesis; and
• 4 a representation of an example to be used with the charging system according to the invention heart valve prosthesis in non-aligned position (A); and after moving the movable receiving element (B).
• In the 1 and 2 is a non-scale embodiment of the charging system according to the invention generally designated 10, with a fixed receiving element 12 and a movable receiving element 14 ,

The fixed receiving element 12 has two groove-shaped recesses 15 and 16 on that in 1 not shown in 2 but are shown schematically. Also, the movable receiving element 14 a groove-shaped recess 17 on that in 1 and 2 is shown schematically and not to scale.

As 1 can also be seen, the recesses are in the 1 and 2 embodiment shown T-shaped or substantially T-shaped. These groove-shaped recesses 15 . 16 . 17 are the dimensions and the design of the stent end elements of the introduced heart valve prosthesis (in the 1 and 2 not shown), so that these flat in the recesses 15 . 16 . 17 be picked up during loading. The manipulator (or machine) presses the stent end elements at the distal end into the recesses 15 . 16 . 17 , and fixes them, by covering retaining means on the receiving elements 12 . 14 , in the recesses 15 . 16 . 17 To fix this solvable, but for the introduction, at the charging system 10 to keep.

3 shows an exemplary heart valve prosthesis 100 with a substantially hollow-cylindrical stent carrier 102 making a stent scaffold. The stent carrier 102 has a proximal end 103 , a proximal section 104 , a middle section 105 , a distal section 106 and a distal end 107 , The stent carrier 102 also has an inner area 130 , a longitudinal axis 131 extending from the proximal end 103 to the distal end 107 extends, as well as a scope 132 ,

The proximal end 103 and the distal end 107 each include "free", ie, wire-shaped, stent ends, designated 134 at the proximal end and 112 at the proximal end. The stent carrier 102 further comprises a series of interconnected diamond-shaped cell structures interconnected 110 extending between the proximal end 103 and the distal end 107 extend.

At the distal end 107 are at the free ends 112 of the stent framework 102 further T-shaped extension structures or stent-end elements 114 provided, extending in the distal direction 204 extend. The free stent ends 134 at the proximal end 103 extend in the proximal direction 202 , Furthermore, radiopaque markers 116 provided the orientation and orientation of the prosthetic heart valve 100 in the body of the patient with appropriate, for example. X-ray control easier.

The material of the stent carrier 102 is preferably nitinol or any other shape memory metal. The flap may be a donor flap, eg a flap from a mammal, or it may be an artificial flap as described above.

The heart valve prosthesis shown here 100 further comprises a flap structure, which with 121 is indicated. This features flap sails, commissure points as well as a hem which forms the inside of the hollow cylindrical stent carrier 102 lining in the middle and distal area.

At the heart valve prosthesis 100 are also radiopaque markers 116 intended.

Of the three T-shaped structures 114 For loading a release system according to the invention, two are inserted into the recesses 15 and 16 of the fixed receiving element inserted, and one in the recess 17 the movable receiving element.

Back to the 1 and 2 is in this still a catheter tube 20 shown, which serves as a heart valve carrier.

Furthermore, in 1 a sliding element 22 shown in the in 1 shown embodiment is exemplified as a thread. The sliding element 22 is with the movable receiving element 14 firmly connected, and can be moved axially by operating the displacement element, which is represented by the arrow Y.

The effects of movement of the movable receiving element on a loaded heart valve prosthesis, as in 3 with example 100 shown are in 4 shown.

In 4A is the heart valve prosthesis 100 with still loaded distal end 107 shown in which the T-shaped structures 114 in the recesses 15 . 16 . 17 the receiving elements 12 and 14 (in the 4A and 4B only indicated schematically as a charging system) are included. The movable receiving element 14 is still immobile.

By moving the receiving element 14 in the proximal direction 202 ie in the direction of the user, which is in the recess 117 recorded T-shaped structure 114 - and with her the Stengerrüst / stent carrier 102 in this area - postponed, whereas those in the recesses 15 . 16 taken in two T-shaped structures in the fixed receiving element relative to the catheter tube 20 stay fixed. This will make the heart valve prosthesis 100 deflected and can be properly aligned in the heart - according to the anatomical conditions.

While various embodiments of the invention have been described, it would be obvious to one of ordinary skill in the art that numerous other embodiments and implementations are possible within the scope of the invention. Further, although various indications of the scope of this invention have been given, the invention is not limited to any of these references, but may be in combination with two or more of these references. Accordingly, the invention is limited only in view of the appended claims and their equivalents.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• WO 2008/070797 [0008]
• WO 2007/098232 [0009]
• WO 2008/138584 A1 [0010]
• EP 2529701 A1 [0039]

Claims (14)

A loading system (10) for releasably holding a heart valve prosthesis (100) on a catheter tube (20), the loading system (10) comprising: - At least one fixed receiving element (12) having at least one groove-shaped recess (15, 16) which is adapted to receive at least one distal end stent member (114) of a heart valve prosthesis (100), and which has a size and shape which is adapted to the respective at least one distal stent-end element (114), wherein the at least one fixed receiving element (12) is fixed axially relative to a catheter tube (20) carrying the heart valve prosthesis (100); and - At least one movable receiving element (14) having at least one groove-shaped recess (17) which is adapted to receive at least one distal stent-end element (114) of a heart valve prosthesis (100), and which has a size and shape, the in each case at least one distal stent-end element (114) is adapted, wherein the at least one movable receiving element (14) relative to a heart valve prosthesis (100) carrying the catheter tube (20) is axially movable. Charging system (10) after Claim 1 , characterized in that it comprises between 1 and 5 fixed receiving elements (12) and between 1 and 3 movable receiving elements (14). Charging system after Claim 1 or 2 , characterized in that the fixed receiving element (12) between 1 and 5 groove-shaped recesses (15, 16) and / or that the movable receiving element (14) has between 1 and 3 groove-shaped recesses (17). Charging system (10) according to any one of the preceding claims, characterized in that the fixed receiving element (12) has two groove-shaped recesses (15, 16) and the movable receiving element (14) has a groove-shaped recess (17). Loading system (10) according to any one of the preceding claims, characterized in that the groove-shaped recess (15, 16, 17) is substantially T-shaped. Loading system (10) according to any one of the preceding claims, characterized in that the movable receiving element (14) with a sliding element (22) is fixedly connected, which sliding element (22) for the axial movement of the movable receiving element (14) is actuated. Charging system (10) after Claim 6 , characterized in that the displacement element (22) is selected from one of the following: a threaded rod arranged on or in the release catheter, a wire, a tube. Charging system (10) according to any one of the preceding claims, characterized in that the movable receiving element (14) is displaceable in the axial direction by between 0.5 cm and 2 cm. A release system for releasing an expandable heart valve prosthesis (100), comprising a loading system (10) according to any one of Claims 1 to 8th , Release system according to Claim 9 characterized in that it comprises: - a catheter tube (20) having a lumen and adapted to support a self-expanding heart valve prosthesis (100); - A charging system (10) according to one of Claims 1 to 8th which is disposed on the catheter tube (20); a retraction sheath (24) adapted to hold the prosthetic heart valve (100) in a compressed state, the retraction sheath (24) being displaceable relative to the heart valve prosthesis (100) in the proximal direction (202) to form the prosthetic heart valve (100 ) gradually release. Release system according to one of Claims 9 or 10 , characterized in that it further comprises a heart valve prosthesis (100). A release system according to claim 11, characterized in that the heart valve prosthesis (100) comprises a self-expanding, substantially cylindrical stent carrier (102) having a plurality of diamond-shaped expandable cell structures (110), and having a proximal end (103) and a distal end (107). which ends (103, 107) both each have a crown with a plurality of free tips (112, 134), wherein at least or exclusively three free tips (1129) are provided at the distal end (107) of the stent carrier (102) Substantially T-shaped extension structures (114), as well as a on the inner surface of the stent carrier (102) fixed flap (121) is provided. Release system according to Claim 11 or 12 , characterized in that the heart valve prosthesis (100) has radiopaque markers (116). Release system according to one of Claims 11 to 13 characterized in that the T-shaped end of the at least or exclusively three tips (112) is formed by an elongated connecting wire structure (114) having a first wire portion with a first end and a second end, wherein the first wire portion is substantially parallel to the longitudinal axis of the stent carrier, and a second wire portion which is provided at the second end of the first wire portion perpendicular thereto and which has a shape selected from substantially round , Oval, oblong rectangular.

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