DE202007005491U1 - Medical device for treating aortic valve insufficiency of patient, has self-expandable endoprosthesis for positioning and fixing heart valve implant in arota of patient, and retaining segment with brackets for receiving implant - Google Patents

Abstract

The device has a self-expandable endoprosthesis (1) for positioning and fixing a heart valve implant in an arota of a patient. A retaining segment has retaining brackets (20, 21) for receiving the heart valve implant. The endoprosthesis has a single-piece structure that is cut from metallic pipe. Position brackets (10, 11) are attached to respective retaining brackets via the structure. Each end section (13) of each position bracket is connected with respective end section (23) of the retaining bracket at a distal end of the endoprosthesis.

Description

The The present invention relates to a medical device for Treatment of aortic valve insufficiency, with a minimally invasive in the body a patient insertable, Self-expanding endoprosthesis for positioning and fixation a prosthetic heart valve in the aorta of the patient, wherein the endoprosthesis at least three position brackets to the self-employed Positioning the medical device in the aorta of the patient and a retaining segment with retaining clips for receiving a heart valve prosthesis, and wherein the endoprosthesis while of introduction the medical device in the body of the patient a first pre-definable shape and in the implanted state of the medical Device has a second pre-definable shape, wherein the medical device in the first shape of the endoprosthesis in a folded state and in the second shape the endoprosthesis is in an expanded state.

A Such device is the principle of medical technology known. Currently stand for the replacement of human heart valves biological or mechanical Flap models available which usually over an opening of the thorax surgically after removal of the diseased heart valve Stitched in the heart valve bed become. For This procedure requires the patient's circulation to be carried by a heart-lung machine being while being implantation of the heart valve prosthesis induced cardiac arrest becomes. This is a risky surgical Intervention with appropriate hazards to the patient and with one long postoperative treatment phase. In particular, such an intervention In multimorbid patients often no longer with a justifiable Risk carried out become.

In recently, At the time, minimally invasive therapy procedures were being developed In particular, characterized in that the intervention in local anesthesia carried out can be. One approach is to use a self-expanding one Stent connected with a collapsible heart valve prosthesis over implant appropriate catheter system in the human body. A Such self-expanding heart valve prosthesis can with the help of a Catheter system by a groin artery or vein to the Implantation place on the heart become. After reaching the implantation site, the stent, in its longitudinal direction for example, from a plurality of self-expanding stent segments which can be bent relative to each other is composed, successively unfolded. After the unfolding For example, the prosthetic heart valve with support from Anchoring hook anchored in the respective blood vessel, at least in the region of the heart become. The actual heart valve prosthesis is here immediately in the proximal region of the stent or the final prosthesis.

For example, from the document DE 100 10 074 A1 a device for fastening and anchoring of heart valve prostheses is known, which is formed essentially of wire-shaped, interconnected elements. It is envisaged that different brackets are used to achieve a secure attachment and support of the heart valve prosthesis. In the device described in this document, three pairs of brackets, which are each arranged at a distance of 120 ° to each other, are used for this purpose. These brackets are connected to each other by solid joints, the solid-state joints fulfill the function of pivot bearings. In addition, oppositely curved stirrups are provided, which form lever arms of the same length as possible, in order to be able to achieve a secure abutment of the stirrups even in the case of peristaltic movements of the heart and blood vessel and a secure sealing of an implanted and fixed heart valve prosthesis.

at the known solution However, there is a risk of incorrect implantation of heart valves. This essentially concerns the exact positioning and longitudinal Alignment of the implanted heart valve prosthesis. Especially is it - if anything - only with great Skill of the treating surgeon possible, a stent, the its proximal end has a heart valve prosthesis, so exactly in nearby Position the patient's diseased heart valve that both a sufficient lateral positional accuracy as well as a suitable longitudinal position of the heart valve prosthesis optimally ensured can be.

A Fehlimplantation example, not optimally positioned Heart valve prosthesis can cause, inter alia, to a leak or Lead to valve insufficiency, which causes significant stress on the ventricle. He follows For example, an implantation of a heart valve prosthesis too far above the actual heart valve level, it may cause occlusion the departures the coronary arteries and thus a deadly one coronary ischemia come with a heart attack. Accordingly, it is imperative that both the lateral positional accuracy as well as the longitudinal position a heart valve prosthesis meets the requirements.

at usual Implantation techniques in which self-expandable heart valve prostheses For example, a groin artery of the patient minimally invasive are led to the implantation at the heart, the introduction of the Prosthesis usually by means of a guide wire and with the help of catheters, using also conventional balloon catheters can be. Although in such an intervention the insertion, about with the help of a fluoroscopy (Cardiac Cath Lab = HKL) or with the help of ultrasound (transesophageal Echocardiogram = TEE) monitored and it can be controlled - as a result of limited maneuverability the during the insertion process still folded heart valve prosthesis, despite their folded State relatively large Has dimensions, often not possible, the required positional accuracy and in particular the longitudinal Location of the implanted heart valve prosthesis with the corresponding ensure fasteners attached thereto. Especially can in case of imminent occlusion of coronary vessels Angular offset of the implanted heart valve prosthesis from the optimal Place of implantation a hazard for the Represent patients.

at the interpretation of a heart valve prosthesis are in particular the while the filling phase of the cardiac cycle (diastole) acting on the prosthesis, considerable personnel to take into account according to which a secure anchoring is required to replace the implanted heart valve prosthesis.

From Therefore, on the one hand, the heart valve prosthesis in the implantation process preferably maneuver well in the appropriate access vessel so as to ensure optimum positional accuracy, and on the other hand, the implanted prosthesis must be in its implantation site firmly anchored to a subsequent offset of the prosthesis to effectively prevent.

Of the The present invention is based on the problem that known devices for transvascular implantation of heart valve prostheses often not suitable, in a simple way a prosthetic heart valve with the implant necessary positioning accuracy. Furthermore so far, if at all, only possible with great effort, an already partially implanted, incorrectly positioned heart valve prosthesis Correct accordingly.

On Basis of this problem, the invention is now the task based, a medical device for the treatment of aortic valve insufficiency to develop the above-mentioned ax to the effect that on the one hand the maneuverability the device during the implantation process is optimized, on the other hand a optimal positional accuracy and fixation of the implanted heart valve prosthesis In a particularly simple manner is feasible to a routine treatment Aortic valve insufficiency without greater burden on the patient to enable.

These Task is with a medical device of the aforementioned Kind solved by that the endoprosthesis of the medical device in one piece a metal tube having cut structure in which each position bracket a headband is assigned, and at which at the distal end of the endoprosthesis each end portion of the position bracket with the end portion of associated headband connected is.

Therefore a medical device is proposed that is substantially from a self-expanding endoprosthesis (hereinafter also simply called "stent"), wherein this stent a flap-bearing retaining segment for receiving a heart valve prosthesis has. The stent design stands out characterized in that at least three position brackets are provided in the second pre-definable shaping of the endoprosthesis radially protrude and are designed in the original (old) heart valves intervene the heart valve to be replaced, thereby reducing in terms on the axial rotation on the one hand and the horizontal position on the other hand, an independent one Fixation and positioning of the medical device achievable is.

There the endoprosthesis (the stent) of the medical device from a metal tube cut, one-piece Has structure, which on the one hand, the position bracket and on the other hand, the holding segment with the brackets comprises, can be the endoprosthesis and thus the medical device especially economical and in big quantity produce. In particular, it is conceivable with the help of a laser the stent structure from a metal tube cut out, and then subjected the structure to a suitable transformation and heat treatment process so that the endoprosthesis and thus the medical device from the collapsed state during implantation into the expanded state can be transferred at the implantation site. This transformation and heat treatment process is advantageously carried out step by step to a damage to prevent the stent structure.

There According to the invention, the endoprosthesis the medical device cut out of a metal tube one-piece Has structure in which each position bracket is assigned a headband, and at which at the distal end of the endoprosthesis each end portion of the positioner with the end portion of the associated retaining bracket is connected, on the one hand, to solid-state joints or similar connection devices be waived. On the other hand, it is the endoprosthesis the medical device according to the present invention to a stent, the one with minimal longitudinal extent on the one functionality the one with the position brackets provided positionability and on the other hand the functionality of the the retaining clips Provided receiving a heart valve prosthesis.

It it can be seen that during the transition the endoprosthesis from the first pre-definable shape to the second pre-definable shape under cross-sectional widening of the entire stent, the headband on the one hand and the position brackets on the other hand are clamped in the radial direction. The second shaping The endoprosthesis is advantageously chosen so that when mounting the holding and position bracket this against the vessel wall of the Aorta toast and with this a non-positive Form connection, thus the medical device in the implantation firmly anchored.

Thereby, that the structure of the endoprosthesis a particularly short design the medical device is medical Device in folded state particularly easy to maneuver, which is particularly advantageous if the implantation leads to the heart valve to be replaced by the aortic arch. The minimum length The medical device is characterized in particular by the particular Ensures the structure of the endoprosthesis, in which at the distal end of the endoprosthesis each end portion of the positioner with the end portion of the associated retaining bracket is connected, with both the position bracket and the headband for proximal retention area of the medical device or extend the endoprosthesis. At the proximal retention area of the Endoprosthesis is thus the holding segment for receiving the heart valve prosthesis in front.

advantageous Developments of the medical device, in particular with regard to the endoprosthesis (of the stent) are specified in the subclaims.

In a particularly preferred realization of the medical Device according to the present invention Invention for use coming endoprosthesis is provided that each position bracket and its associated headband each having a substantially U- or V-shaped structure, the closed to the proximal end of the endoprosthesis out. Especially it is preferred that each position bracket from the material section of the metal tube is cut, which is received by the substantially U-shaped or V-shaped structure of the associated retaining bracket becomes. In this preferred realization of the stent structure is Thus provided that the respective retaining bracket of the retaining segment to the proximal Retention area of the endoprosthesis form, being symmetrical to the retaining clips the respective position brackets are formed, however, somewhat further in the direction of the distal Retention area of the medical device are present. The respective distal ends of the position brackets are with the respective ones distal ends of the associated headband at the distal retention area of the medical device or connected to the endoprosthesis. In the expanded state of the medical Device tightens not only the proximal retention area with the attached heart valve prosthesis and the between the proximal and the distal retention area of the medical Device arranged position bracket, but also at the distal End of the medical device lying connection points between the respective position brackets and brackets on, so over the distal retention area of the medical device as well a radially acting force is exerted on the vessel wall, whereby the fixation the medical device is further supported in the implantation.

There in the second shape of the endoprosthesis, the medical device is in an (expanded) state in which the distal and proximal retention area and the position bracket radially clamped In comparison, the expanded medical device has to its collapsed state a shortened length. To the length of Pre-set medical device in its expanded state to be able to it is conceivable with the respective distal end portions of the position bracket with the distal end portions of the associated headband not directly but using a substantially longitudinal direction connect the endoprosthesis extending connecting web. By a suitable choice of length This connecting web can thus the length of the medical device be adapted in the expanded state. However, it is preferred especially with regard to the best possible maneuverability the medical device during the implantation procedure, i. if the endoprosthesis is in its first (folded) form, that the connecting web between the respective end portions the position bracket and headband preferably short-listed is.

In a particularly preferred development of the medical Device is provided that the endoprosthesis at its distal End further comprises fastening means, which with a Einführkathetersystem can be brought into engagement. In a preferred realization in With regard to the fasteners, it is conceivable that these each have a fixing lug arranged between two adjacent position brackets, wherein the respective arms of the adjacent position bracket on the one hand and the respective arms of the associated to the adjacent position brackets headband on the other hand connected to the attachment lug. Here too It is again conceivable that the respective arms of the adjacent position bracket directly and the respective arms of the associated to the adjacent position bracket headband indirectly via a substantially longitudinal direction the endoprosthesis extending connecting web are connected. All generally, those provided at the distal end of the endoprosthesis Fastening means for receiving suitable facilities on insertion catheter, these devices being complementary to the fastening means the endoprosthesis are formed. The procedure between the catheter system on the one hand and the attachment means on the distal end of the endoprosthesis On the other hand, with the help of an external manipulation, it is possible to solve release the medical device in the implantation site and the expansion of the medical device and thus the safe To ensure fixation of this. Of course come as a fastener but other solutions in question.

As already indicated, is by the special Endoprothesenstruktur it is possible a self-expanding medical device As already indicated, is possible by the special Endoprothesenstruktur, a self-expandable medical device that can be used by their short overall length characterized in the folded state and thus an improved maneuverability during the implantation process, while at the same time self-positioning in the pockets of the old heart valve with the help of the position bracket and the secure anchoring of the endoprosthesis by the in the expanded Condition radially pressing against the vessel wall ensures proximal and distal retention areas of the endoprosthesis is.

alternative to the aforementioned preferred development of the medical Device in which the respective arms of the adjacent position brackets directly and the respective arms of the associated to the adjacent position brackets headband indirectly via a substantially longitudinal direction of the Endoprosthesis extending connecting bar connected to the mounting lug But it is also conceivable that the respective arms of the neighboring positioning brackets indirectly via a substantially longitudinal direction the endoprosthesis extending connecting web connected to the attachment eye are, wherein the respective arms of the associated to the adjacent position brackets headband indirectly via a substantially longitudinal direction the endoprosthesis extending connecting web connected to the attachment eye are, and wherein the connecting web of the headband at the end portion of the position bracket in the connecting web the position bracket goes over. By providing the respective connecting webs for connection the arms of the positioners with the attachment eye or for connecting the arms of the headband with the end portion of the positioning brackets it is in a particularly easy to implement but nevertheless effective way possible the length adapt the endoprosthesis to the respective requirements, and though by the respective lengths the connecting webs are selected accordingly.

Around to achieve that the distal retention area of the endoprosthesis in its expanded state particularly safe in the implantation site is held in a preferred further development of the solution according to the invention, that the endoprosthesis at its distal retention area with eyelets or is provided, which preferably between two arranged adjacent position bars eyelets are each provided with at least one barb, the top towards the proximal end of the endoprosthesis. At this preferred development is thus the fixation of the endoprosthesis in the implantation site not only because of the endoprosthesis, and in particular of the distal retention area of the endoprosthesis on the vessel wall exerted radial force, but also caused by the engagement of the barbs in the vessel wall. Of course are also other suitable implementations in terms of barbs conceivable.

alternative or additionally to the aforementioned, preferably provided on the eyelets Barb is it for secure fixation of the endoprosthesis in the implantation site conceivable that the respective arms of the headband of the endoprosthesis respectively an anchorage post in the form of a temple which in the expanded state of the endoprosthesis of the associated arm of the headband protrudes, and whose tip in the direction of the distal end of the Endoprosthesis points. Through this development is thus a additional Fixation of the endoprosthesis and therefore an additional safeguard of the medical Device against a dislocation feasible.

In a preferred realization of the anchor support, it is conceivable that the Anchorage support one essentially U- or V-shaped Has structure to the distal end of the endoprosthesis or to the distal End of the medical device is closed out, the distal area of the anchorage post forms the tip of the anchorage post, and wherein the respective arms of the anchor support at the proximal end of the anchor post connected to the respective arms of two adjacent brackets are.

on the other hand may be provided in a preferred development that the respective arms of the headband continuous slots or slots have, extending in the longitudinal direction extend the headband, and which serve to expand the endoprosthesis from the collapsed State to enable or support the expanded state because these slots or slots are preferably designed such a particularly easy to implement Cross-sectional expansion of the stent (the endoprosthesis) with simultaneous reduction in length to enable. Such slots or slots have the further advantage of saving material.

at the latter embodiment, in which extending in the respective brackets in the longitudinal direction of the headband Slots are introduced, which are designed, the second shape To influence the endoprosthesis, it is conceivable that the respective headband additionally reinforcement portions which have the longitudinal direction the headband interrupting running slits, and which one protruding of components of the headband in the expanded state of the endoprosthesis prevent what, in particular with regard to an explantation of the medical device is beneficial.

In a preferred embodiment, the endoprosthesis in its first Shaping an outer diameter of about 5.0 mm and a length between 33.0 mm to 40.0 mm, preferably between 34.0 to 39.0 mm, and more preferably between 34.37 mm and 38.37 mm, whereby the medical device, for example via a 21F delivery system insertable and for Heart valve prostheses with a diameter of 21 mm to 23 mm applicable is. The above lengths are currently preferred values, based on this is the medical Device for the main part of the patients to be treated.

Around a particularly secure anchoring of the implanted medical To achieve device in its expanded state is provided that the endoprosthesis is manufactured in such a way that it and heat treatment process was subjected to that in the finished state of the endoprosthesis These in their second shaping a slightly concave, in the direction the proximal retention area of the endoprosthesis tapered design having.

Different expressed this means that the proximal retention area of the endoprosthesis, i.e. ie the area where the heart valve prosthesis is attached becomes a bit rejuvenated Diameter compared to the distal retention area has. In particular, it has been shown that in one case, when the distal Retention area of the present in the second shaping endoprosthesis an approximately 10% to 25% larger diameter than the diameter of the proximal retention area of the Endoprosthesis, in particular at the distal retention area of the endoprosthesis radial forces be generated, which provides a secure hold of the medical device in the vessel without it a damage allow the vessel wall whereby the peristaltic movements of the heart or the vessel wall reliably concern will be carried. The slightly lower radial force, that of the proximal Retention area of the endoprosthesis is exercised, is not only for Anchoring the medical device in the aorta, but in particular also for clamping on the proximal retention area the endoprosthesis attached heart valve prosthesis and for reliable sealing this opposite the vessel wall. Of course it is but it is also conceivable that the concave design of itself in the second Forming present endoprosthesis stronger or less strong is.

in the however, it is preferred that the individual be in the second shape the proximal retention area of the endoprosthesis has a diameter between 22 mm to 33 mm, and preferably between 25 mm to 31 mm, has. It is conceivable that the endoprosthesis two or has several different sized sizes, depending on Patient an optimal size of the endoprosthesis selected is, and where the exact and to be treated patients adapted dimension of the endoprosthesis - starting from a given Stent size - by a suitable after-treatment of the endoprosthesis (the stent), in particular by annealing, is feasible.

In a particularly preferred realization of the medical device, this not only has the Endoprosthesis (or the stent) but also a heart valve prosthesis, preferably a Bioherzklappenprothese on, which is attached to the retaining segment of the endoprosthesis by means of a thread or the like, wherein in the headband of the endoprosthesis through holes are introduced, through which the thread or the like is guided , Thus, it is therefore conceivable that the heart valve prosthesis is connected to the retaining segment of the endoprosthesis only immediately before the medical intervention. In order for a modular design of the medical device can be realized, which is particularly advantageous in terms of the transport and storage of the medical device.

in the Regard to the preferably for the endoprosthesis of the medical device used material is a shape memory material provided, which is designed such that the endoprosthesis below Acting on an external stimulus from a temporary Form deformed into a permanent shape, the temporary shape in the first shape of the endoprosthesis (in the folded State of the medical device) and the permanent shape in the second shape of the endoprosthesis (in the expanded state the medical device) is present. In particular, by the fact that a shape memory material such as nitinol, i. an equiatomic alloy of nickel and titanium, is used when implanting the medical Device a particularly gentle implantation possible.

at the manufacture of the endoprosthesis formed from a shape memory material It is envisaged that after cutting out the stent structure from the metal tube these deformed and in the desired permanent form, which is known as "programming." This On the one hand, the process can take place in such a way that the stent structure is heated and deformed and then cooled becomes. On the other hand, the stent structure can also be at low temperature deformed, which is called "cold Stretching "known is. This saves the permanent shape while the temporary Form currently available. Is subsequently on the stent structure an external stimulus acted, it comes to triggering of the shape memory effect and to restore the saved permanent form.

In In a particularly preferred embodiment, it is provided that the external stimulus is a definable switching temperature. It is therefore conceivable that the Trigger the shape memory effect and thus to restore the stored permanent form the endoprosthesis a warming of the endoprosthesis material to a temperature higher than the switching temperature must be made. By a suitable choice of chemical composition of the shape memory material can be set a specific switching temperature in advance.

So the switching temperature in the range of room temperature is particularly preferred and body temperature of the patient. This is especially with regard to the field of application of the medical device as an implant in a body a patient's advantage. Accordingly, when implanting the medical Device only to make sure that the instrument only when implanted to the body temperature (36 ° C) of the patient heated and thus the shape memory effect of the endoprosthesis material is triggered.

in the The following are preferred embodiments for one Endoprosthesis of the medical invention Device with reference to the attached Drawings closer described.

He demonstrate:

1a a first preferred embodiment of a self-expanding endoprosthesis for the medical device according to the invention in its first predetermined shape, in which the medical device is in its folded state;

1b the endoprosthesis according to 1a in a state between its first pre-definable shape and its second shape, in which the medical device is in its expanded state;

1c the endoprosthesis according to 1a in its second configuration, in which the medical device is in its expanded state;

1d a first preferred embodiment of the medical device according to the invention in its expanded state with an endoprosthesis according to 1c and a heart valve prosthesis attached and clamped thereto;

1e a planar projection of a cutting pattern, which is applicable in the production of the first preferred embodiment of the self-expandable endoprosthesis to the endoprosthesis according to 1a to cut in one piece from a metal tube;

2a a second preferred embodiment of a self-expanding endoprosthesis for the medical device of the invention in its first predetermined shape in which the medical device is in its folded state;

2 B the endoprosthesis according to 2a in a state between its first pre-definable shape and its second shape, in which the medical device is in its expanded state;

2c the endoprosthesis according to 2a in its second configuration, in which the medical device is in its expanded state;

2d a second preferred embodiment of the medical device according to the invention in its expanded state with an endoprosthesis according to 2c and a heart valve prosthesis attached and clamped thereto;

2e a planar projection of a cutting pattern, which is applicable in the production of the second preferred embodiment of the self-expandable endoprosthesis to the endoprosthesis according to 2a to cut in one piece from a metal tube;

3a a third preferred embodiment of a self-expanding endoprosthesis for the medical device according to the invention in its first predetermined shape, in which the medical device is in its folded state;

3b the endoprosthesis according to 3a in a state between its first pre-definable shape and its second shape, in which the medical device is in its expanded state;

3c the endoprosthesis according to 3a in its second configuration, in which the medical device is in its expanded state;

3d a third preferred embodiment of the medical device according to the invention in its expanded state with an endoprosthesis according to 3c and a heart valve prosthesis attached and clamped thereto;

3e a planar projection of a pattern, which is in the production of the third preferred embodiment of the self-expandable En endrothesis applicable to the endoprosthesis according to 3a to cut in one piece from a metal tube;

4a a fourth preferred embodiment of a self-expanding endoprosthesis for the medical device according to the invention in its first predetermined shape, in which the medical device is in its folded state;

4b the endoprosthesis according to 4a in a state between its first pre-definable shape and its second shape, in which the medical device is in its expanded state;

4c the endoprosthesis according to 4a in its second configuration, in which the medical device is in its expanded state;

4d a fourth preferred embodiment of the medical device according to the invention in its expanded state with an endoprosthesis according to 4c and a heart valve prosthesis attached and clamped thereto;

4e a planar projection of a cutting pattern, which is applicable in the production of the fourth preferred embodiment of the self-expandable endoprosthesis to the endoprosthesis according to 4a to cut in one piece from a metal tube;

5a a fifth preferred embodiment of a self-expanding endoprosthesis for the medical device of the invention in its first predetermined configuration in which the medical device is in its folded state;

5b the endoprosthesis according to 5a in a state between its first pre-definable shape and its second shape, in which the medical device is in its expanded state;

5c the endoprosthesis according to 5a in its second configuration, in which the medical device is in its expanded state;

5d a fifth preferred embodiment of the medical device according to the invention in its expanded state with an endoprosthesis according to 5c and a heart valve prosthesis attached and clamped thereto;

5e a planar projection of a cutting pattern, which is applicable in the production of the fifth preferred embodiment of the self-expanding endoprosthesis to the endoprosthesis according to 5a to cut in one piece from a metal tube;

6a a sixth preferred embodiment of a self-expanding endoprosthesis for the medical device of the invention in its first predetermined configuration, in which the medical device is in its folded state;

6b the endoprosthesis according to 6a in a state between its first pre-definable shape and its second shape, in which the medical device is in its expanded state;

6c the endoprosthesis according to 6a in its second configuration, in which the medical device is in its expanded state;

6d a sixth preferred embodiment of the medical device according to the invention in its expanded state with an endoprosthesis according to 6c and a heart valve prosthesis attached and clamped thereto;

6e a planar projection of a cutting pattern, which is applicable in the production of the sixth preferred embodiment of the self-expandable En doprothese to the endoprosthesis according to 6a to cut in one piece from a metal tube;

7a a seventh preferred embodiment of a self-expanding endoprosthesis for the medical device of the invention in its first predetermined configuration in which the medical device is in its folded state;

7b the endoprosthesis according to 7a in a state between its first pre-definable shape and its second shape, in which the medical device is in its expanded state;

7c the endoprosthesis according to 7a in its second configuration, in which the medical device is in its expanded state;

7d a seventh preferred embodiment of the medical device according to the invention in its expanded state with an endoprosthesis according to 7c and a heart valve prosthesis attached and clamped thereto;

7e a planar projection of a cutting pattern, which is applicable in the preparation of the seventh preferred embodiment of the self-expandable endoprosthesis to the endoprosthesis according to 7a to cut in one piece from a metal tube;

8a an eighth preferred embodiment of a self-expanding endoprosthesis for the medical device of the invention in its first predetermined configuration in which the medical device is in its folded state;

8b the endoprosthesis according to 8a in a state between its first pre-definable shape and its second shape, in which the medical device is in its expanded state;

8c the endoprosthesis according to 8a in its second configuration, in which the medical device is in its expanded state;

8d an eighth preferred embodiment of the medical device according to the invention in its expanded state with an endoprosthesis according to 8c and a heart valve prosthesis attached and clamped thereto;

8e a planar projection of a cutting pattern, which is applicable in the production of the eighth preferred embodiment of the self-expandable endoprosthesis to the endoprosthesis according to 8a to cut in one piece from a metal tube;

9a a ninth preferred embodiment of a self-expanding endoprosthesis for the medical device according to the invention in its first predetermined shape, in which the medical device is in its folded state;

9b a perspective side view of a connecting web between an end portion of a position clip and an end portion of an associated retaining clip in the endoprosthesis according to 9a in its second configuration, in which the medical device is in its expanded state;

9c a perspective side view of a position bracket and the associated headband of the endoprosthesis according to 9a in its second configuration, in which the medical device is in its expanded state;

9d a perspective top view of the distal portion of the endoprosthesis according to 9a in its second configuration, in which the medical device is in its expanded state;

9e a planar projection of a cutting pattern, which is applicable in the preparation of the ninth preferred embodiment of the self-expandable endoprosthesis to the endoprosthesis according to 9a to cut in one piece from a metal tube;

10 a planar projection of a cutting pattern, which is applicable in the manufacture of another preferred embodiment of the self-expandable endoprosthesis to cut an endoprosthesis in one piece from a metal tube;

11 a further preferred embodiment of a self-expanding endoprosthesis of the medical device according to the invention in its second shape, in which the medical device is in its expanded state;

12a a schematic view for explaining a possible implantation process for the medical device according to the present invention; and

12b a schematic view of the medical device according to the present invention in the implanted state.

The following will be referred to first with reference to 1a to 1e a first preferred embodiment of the self-expanding endoprosthesis 1 for the medical device according to the invention. It shows 1a the endoprosthesis 1 in its first pre-definable shape in which the medical device (not explicitly shown) is in a collapsed state and thus minimally invasive into the body of a patient by means of a catheter system. 1c shows the endoprosthesis 1 in its second configuration, in which the medical device is in its expanded state. 1b shows the endoprosthesis 1 in a state between the first shaping (cf. 1a ) and the second shaping (cf. 1c ). In 1d is a first preferred embodiment of the medical device according to the invention in its expanded state with an endoprosthesis according to 1c and an attached and clamped heart valve prosthesis shown.

The endoprosthesis 1 According to the first preferred embodiment, it is characterized in that it has a structure cut in one piece from a metal tube. The cutting pattern used in forming the stent design is in a two-dimensional projection in FIG 1e shown. In detail, the endoprosthesis includes 1 a total of three position brackets 10 which perform the function of autonomously positioning the medical device in the aorta of the patient. The position brackets 10 have a rounded head section 12 which, in the positioning of the medical device in the implantation site, engage in the pockets of the incompetent heart valve to be replaced with the medical device. By providing a total of three position brackets 10 the necessary positional accuracy in the direction of rotation can be taken care of.

The each to the proximal end 3 the endoprosthesis 1 pointing head sections 12 the position bracket 10 are rounded accordingly, so that when engaging the position bracket 10 in the pockets of the heart valve to be replaced, the vessel wall is not damaged. From the head section 12 the position bracket 10 to the distal end 2 the endoprosthesis 1 extend each position bracket 10 a total of two position webs or arms 11 at the distal end 2 the endoprosthesis 1 in a loop-shaped element 30 pass. This eye-shaped element 30 serves as a fastener for securing the endoprosthesis 1 and thus the medical device with an introducer catheter system.

In particular, the respective eyelets are 30 between the two arms 11 two mutually adjacent position bracket 10 arranged. In the transition section 13 between the two arms 11 two mutually adjacent position bracket 10 in which the attachment eyelet 30 is formed, further opens a substantially in the longitudinal direction of the endoprosthesis 1 extending connecting bridge 15 , At the proximal end of the connecting bar 15 this goes into the respective holding arms 21 two mutually adjacent headband 20 above.

Due to this stent design, an axisymmetric structure is achieved, with each position bracket 10 a headband 20 assigned. The endoprosthesis 1 the in 1a to 1c illustrated preferred embodiment thus has a total of three headband 20 on which is a retaining segment of the endoprosthesis 1 for receiving an example in 1d illustrated heart valve prosthesis 40 justify. By providing the respective connecting webs 15 between the distal transition sections 23 two mutually adjacent headband 20 and the transitional sections 13 two mutually adjacent position bracket 10 a stent structure is realized in which the respective arms 11 a position bracket 10 with the respective arms 21 one to the position bracket 10 associated retaining bracket 21 essentially parallel to each other.

In the in 1a shown state of the endoprosthesis 1 , in which it is in its first shape, the respective arms border 11 the position bracket 10 directly to the respective arms 21 the associated headband 20 at.

It is especially on 1c Reference is made in which the endoprosthesis 1 is shown in its second shape according to the preferred first embodiment. In this illustration, it can be seen in particular that each position bracket 10 and its associated headband 20 each having a substantially U- or V-shaped structure, which to the proximal end 3 the endoprosthesis 1 is closed. In detail, each position bracket 10 cut from the material portion of the metal tube, that of the substantially U- or V-shaped structure of the associated retaining clip 20 is recorded, as is the in 1e illustrated pattern can be removed.

The comparison of 1a and 1c shows that the transition from the first shaping to the second shaping of the endoprosthesis 1 a shortening of these in the longitudinal direction with simultaneous cross-sectional enlargement, in particular of the distal and the proximal retention area 2 . 3 , he follows. In the expanded state of the endoprosthesis 1 are the respective position brackets 10 in particular, they are spanned even more in the radial direction than in the distal retention area 2 of the stent 1 the case is.

The position brackets 10 , which take over the function of positioning the medical device in the implanted state by engaging in the pockets of the old, to be replaced heart valve can be characterized by the fact that they protrude more in the radial direction, insert in a particularly easy manner in the heart valve pockets of the heart valve to be replaced.

In 1d is a first preferred embodiment of the medical device according to the invention in its expanded state with an endoprosthesis 1 according to 1c and one with the help of one thread 41 attached and unfolded heart valve prosthesis 40 shown. It can be seen that by spreading the proximal retention area 3 the endoprosthesis 1 in which the heart valve prosthesis 40 is arranged, that is, this heart valve prosthesis 40 spans while simultaneously with the proximal end portions 22 the headband 21 a radial force is exerted on the vessel wall (not shown), whereby a secure sealing of the heart valve prosthesis 40 is ensured against the vessel wall.

Even if the radial direction of the brackets 21 force applied to the vessel wall leads to a certain fixation of the medical device in the implantation site, in order to achieve a permanently stable implantation of the medical device, in particular in the unavoidable peristaltic movement of the vessel wall and the relatively high fluid pressures that occur distal retention area 2 expanded in the expanded state of the medical device by 10% to 25% in the radial direction, as in the proximal retention area 3 the endoprosthesis 1 the case is. This preserves the endoprosthesis 1 in its second shape a slightly concave, towards the proximal retention area 3 the endoprosthesis 1 tapered design, which ensures that by pressing the distal retention area 2 the endoprosthesis 1 a secure anchoring of the medical device in the vessel is realized on the vessel wall.

The respective arms 21 the headband 20 have in the illustrated embodiment, continuous slots or slots 24 on, which serve to expand the endoprosthesis 1 From the folded state to the expanded state to enable or support, since these slots or slots 24 to a more easily realized cross-sectional enlargement of the stent 1 with simultaneous reduction in length. Of course, it would also be conceivable that these slots or slots 24 a thread 41 or the like, for fixing the in 1d illustrated heart valve prosthesis 40 at the proximal area 3 the endoprosthesis 1 serves.

The solution according to the invention is thus a modular medical device which consists essentially of the two components to be produced separately, endoprosthesis 1 and heart valve prosthesis 40 exist, with the endoprosthesis 1 the function of positioning and fixing the heart valve prosthesis 40 in the aorta of the patient. Both components (endoprosthesis 1 and heart valve prosthesis 40 ) can preferably be connected to each other just before the surgical procedure; This is with regard to the transport and storage of the endoprosthesis 1 as such advantageous since the endoprosthesis 1 is a mechanically relatively robust component and can be stored in particular for a long time. This is especially true when the endoprosthesis 1 stored in their second shape, ie in the expanded state, and brought into their first (folded) shape just before the surgical procedure.

The in 1a shown condition of the endoprosthesis 1 in which the endoprosthesis 1 is in its first shape and the medical device is in its collapsed state, the so-called "temporary" shape of the endoprosthesis structure formed from a shape memory material is applied to the endoprosthesis shape according to FIG 1a an external stimulus acted, it comes to trigger the Formgedächniseffekts and thus to restore the in the manufacture of the endoprosthesis 1 specified, stored permanent form according to 1c , This external stimulus is preferably a definable switching temperature, wherein to trigger the Formgedächniseffekts and thus to restore the stored permanent shape of the endoprosthesis 1 a heating of the shaped body must be at a temperature higher than the switching temperature. By a suitable choice of the chemical composition of the endoprosthesis 1 used material can be set in advance a certain switching temperature; in the preferred realization of the inventions to the invention solution, this is in a range between 20 ° C and the body temperature of the patient.

When implanting the medical device, it is thus conceivable that the medical device, for example, during the insertion process is cooled accordingly. If the medical device has preferably been advanced to the desired implantation site, ie, to the native heart valve with the aid of a suitable delivery catheter system, the cooling can be interrupted in order to ensure that the endoprosthesis 1 the medical device is heated to the body temperature (36 ° C) of the patient and thus the Formgedächniseffekt the Endoprothesenmaterials is triggered. Due to the self-expanding property of the endoprosthesis triggered thereby 1 Radial forces develop on the individual components of the endoprosthesis 1 , and in particular at the respective position brackets 10 . 11 and brackets 20 . 21 the endoprosthesis 1 attack. Because the endoprosthesis 1 the medical device is still in the Einführkathetersystem, which are after exceeding the critical Switching temperature developing and on the individual components of the endoprosthesis 1 attacking radial forces are still compensated by the introducer sheath of Einführkathetersystems, so that - despite triggering the Formgedächniseffekts - the endoprosthesis 1 the medical device is constrained in its first (folded) shape.

By a suitable gradual release of the endoprosthesis 1 From the Einführkathetersystem it is then possible, for example, first the position bracket 10 . 11 the endoprosthesis 1 to dismiss from the introducer sheath of Einführkathetersystems, as a result, these span because of the attacking radial forces in the radial direction. The clamped position brackets 10 . 11 can then be positioned in the pockets of the native heart valve.

Subsequently, the remaining components of the endoprosthesis 1 or the medical device released from the introducer sheath of Einführkathetersystems. The brackets are cocked 20 . 21 in the radial direction and thus unfold umbrella-like on the brackets 20 . 21 , for example with the help of a thread 41 etc., attached heart valve prosthesis 40 , The on the brackets 20 . 21 but also at the distal retention area 2 the endoprosthesis 1 attacking radial forces cause the endoprosthesis 1 is pressed in the radial direction against the vessel wall, which on the one hand a secure anchoring of the medical device in the implantation site and on the other hand, a reliable seal the heart valve prosthesis 40 at the proximal retention area 3 the endoprosthesis 1 guaranteed.

In the 2a to 2c is a second preferred embodiment of a self-expanding endoprosthesis 1 for the medical device according to the invention in its first pre-definable shape (see 2a ), in its second pre-definable shape (cf. 2c ), as well as in an intermediate state (cf. 2 B ).

In 2d is a second preferred embodiment of the medical device according to the invention in its expanded state with an endoprosthesis according to 2c and an attached and unfolded prosthetic heart valve 40 shown. A planar projection of a cutting pattern which is applicable in the production of the second preferred embodiment of the self-expanding endoprosthesis is shown in FIG 2e shown. This pattern is suitable for the endoprosthesis according to 2a to cut in one piece from a metal tube.

The endoprosthesis 1 according to the second preferred embodiment substantially corresponds to the previously with reference to the 1a to 1e described first preferred embodiment. In contrast to the first preferred embodiment of the endoprosthesis is provided in the second embodiment that the respective arms 11 the adjacent position bracket 10 indirectly over a substantially longitudinal direction of the endoprosthesis 1 extending connecting web 16 with the attachment eye 30 are connected, with the respective arms 21 the adjacent position bars 10 associated headband 20 indirectly over a substantially longitudinal direction of the endoprosthesis 1 extending connecting web 15 with the attachment eye 30 are connected. In detail, the connecting bridge goes 15 the headband 20 at the end section 13 the position bracket 10 in the connecting bridge 16 the position bracket 10 above. By a suitable choice of the respective length of the two connecting webs 15 and 16 thus can easily increase the overall length of the stent 1 be set.

In the 3a to 3c illustrated third preferred embodiment of a self-expandable endoprosthesis for the medical device according to the invention substantially corresponds to the first preferred embodiment according to the 1a to 1c ; with the difference that in the third preferred embodiment, the between two adjacent position brackets 10 arranged eyelets 30 with barbs 17 are provided, whose respective tips in the direction of the proximal end 3 the endoprosthesis 1 point. In this modification of the type of heart valve stent 1 Thus, according to the first preferred embodiment, an additional anchoring of the system to a dislocation of the stent 1 towards the left ventricle.

In 3d is a third preferred embodiment of the medical device according to the invention in its expanded state with an endoprosthesis according to 3c and an attached and unfolded prosthetic heart valve 40 shown. This representation corresponds essentially to the 1d ; but with the exception of the previously described barb elements 17 which at the respective eyelets 30 are provided.

A planar projection of a pattern, which in the production of the third preferred Embodiment of the self-expanding bite endoprosthesis 1 applicable, the 3e be removed. This pattern is particularly suitable for the endoprosthesis according to 3a to cut in one piece from a metal tube.

In 4a to 4c is a fourth preferred embodiment of a self-expanding endoprosthesis 1 represented for the medical device according to the invention. A fourth preferred embodiment of the medical device according to the invention in its expanded state with an endoprosthesis according to 4c and an attached and unfolded prosthetic heart valve 40 is in 4d shown while in 4e a planar projection of a pattern is shown, which in the production of the fourth preferred embodiment of the self-expandable endoprosthesis 1 is applicable. The pattern according to 4e is particularly suitable to the endoprosthesis according to 4a to cut in one piece from a metal tube.

The fourth preferred embodiment of the self-expanding endoprosthesis 1 corresponds to a combination of the second and third preferred embodiments described above. In detail, therefore, are the respective arms 11 the adjacent position bracket 10 indirectly over the substantially extending in the longitudinal direction of the endoprosthesis connecting web 16 with the attachment eye 30 connected while at the respective eyelets 30 barb 17 are provided, the tip of which in the direction of the proximal end 3 the endoprosthesis 1 has. The achievable with the features provided in the fourth preferred embodiment features have been described above and will not be listed again at this point.

In the 5a to 5e illustrated fifth preferred embodiment of a self-expanding endoprosthesis 1 or a medical device according to the invention substantially corresponds to the reference to 1a to 1e described first preferred embodiment, although now the respective headband 21 the endoprosthesis 1 with reinforcement sections 26 are provided, which in the longitudinal direction of the headband 21 running slots 24 interrupt. These reinforcement sections 26 serve to spread the individual components of the headband 21 , and in particular a radial breaking out of the anchoring support 25 from the hangers 20 to avoid. Thus, with the reinforcing sections 26 a holding section for the stent 1 be realized, which does not have an explantation of the medical device preventing components in the expanded state.

In 5e FIG. 2 shows a planar projection of a cutting pattern which is used in the production of the fifth preferred embodiment of the self-expanding endoprosthesis 1 applicable to the endoprosthesis 1 according to 5a to cut in one piece from a metal tube.

The in the 6a to 6e illustrated sixth preferred embodiment of the self-expandable endoprosthesis or the medical device according to the invention corresponds to a combination of the second preferred embodiment according to the 2a to 2e and the above-described fifth preferred embodiment according to FIGS 5a to 5e , In detail, therefore, in the endoprosthesis 1 according to the second preferred embodiment additional reinforcement sections 26 at the respective retaining clips 21 provided, which in the longitudinal direction of the headband 21 running slots 24 interrupt.

The in the 7a to 7e illustrated seventh preferred embodiment of the endoprosthesis 1 or the medical device according to the invention corresponds to a combination of the third and fifth embodiments described above, in which therefore on the one hand, the respective attachment eyelets 30 with barbs 17 and on the other hand, the respective headband 21 with reinforcement sections 26 are provided.

The in the 8a to 8e illustrated eighth preferred embodiment of the self-expanding endoprosthesis or the medical device according to the invention corresponds to a combination of the fourth and the fifth embodiment, in which therefore the respective headband 21 with reinforcement sections 26 are provided while those with the barbs 17 provided eyelets 30 over a substantially longitudinal direction of the endoprosthesis 1 extending connecting web 16 with the respective arms 11 the adjacent position bracket 10 are connected.

The in the 9a to 9d illustrated ninth preferred embodiment of the self-expandable endoprosthesis 1 for the medical device according to the invention has a comparison with the first embodiment (see 1a to 1c ) slightly modified design. The endoprosthesis 1 according to the ninth embodiment is in 9a presented in their first predetermined shape. The 9b and 9c each represent a perspective side view of the endoprosthesis 1 according to the ninth embodiment in its second shape 9b the connecting bridge 15 between the end section 13 a position bracket 10 . 11 and the end section 23 an associated retaining bracket 20 . 21 to recognize. On the other hand, based on the 9c the position brackets 10 . 11 and the associated headband 20 . 21 the endoprosthesis 1 according to 9a be well recognized.

In 9e a planar projection of a pattern is shown, which is in the production of the ninth preferred embodiment of the self-expandable En endrothesis applicable to the endoprosthesis according to 9a to cut in one piece from a metal tube.

In contrast to the first embodiment, in the ninth embodiment of the endoprosthesis 1 each to the proximal end 3 the endoprosthesis 1 pointing head sections 12 the position bracket 10 slightly wider at the proximal end. Although here have the head sections 12 the position bracket 10 a slightly rectangular compared to the first embodiment, but also here are the respective corners of the head sections 12 rounded, so that when engaging the position bracket 10 in the pockets of the heart valve to be replaced, the vessel wall is not damaged. The slightly wider version of the head sections 12 the position bracket 10 has the advantage that during the implantation process the position bar 10 can be placed in the pockets of the native heart valve with as little play as possible, thus allowing an even more accurate positioning of the medical device in the implantation.

As in the previously described embodiments, in the ninth embodiment, the endoprosthesis 1 extends from the head portion 12 the position bracket 10 to the distal end 2 the endoprosthesis 1 each position bracket 10 a total of two position webs or arms 11 at the distal end 2 the endoprosthesis 1 in a loop-shaped element 30 pass. This eye-shaped element 30 serves as a fastener for securing the endoprosthesis 1 and thus the medical device with an introducer catheter system.

Specifically, in the ninth embodiment, the endoprosthesis 1 the respective eyelets 30 between the two arms 11 two mutually adjacent position bracket 10 arranged. In the transition section 13 between the two arms 11 two mutually adjacent position bracket 10 in which the attachment eyelet 30 is formed, which opens substantially in the longitudinal direction of the endoprosthesis 1 extending connecting bridge 15 , At the proximal end of the connecting bar 15 this goes into the respective holding arms 21 two mutually adjacent headband 20 above. This structure is in particular also on the basis of 9d good to see the perspektivi cal top view of the distal region of the endoprosthesis according to 9a in its second shape shows.

In contrast to the embodiments described above, in the ninth embodiment of the endoprosthesis 1 the respective holding arms 21 the headband 20 at the transition section 23 between the two arms 21 two mutually adjacent headband 20 not with a slit or slots 24 Mistake. Because of that in the transition section 23 between the two arms 21 two mutually adjacent headband 20 each headband 20 in fact only a bridge 21 opens, is achieved in an advantageous manner that in the expanded state of the endoprosthesis 1 (compare for example 9b ) of the respective brackets 20 none to the headband 20 associated components project in the radial direction. In particular, occurs in the expanded state of the endoprosthesis 1 at the respective transitional sections 23 between the two arms 21 two mutually adjacent headband 20 usually not through the slots 24 formed barb portion in the radial direction, the tip in the direction of the distal retention area 2 the endoprosthesis 1 shows. The fact that in the ninth embodiment dispenses with such a barb portion, the endoprosthesis 1 particularly easily explanted and removed again from the body of the patient.

Although in the ninth embodiment of the endoprosthesis 1 at the respective transitional sections 23 between the two arms 21 two mutually adjacent headband 20 no slots or slots 24 are provided have the respective retaining arms 21 the endoprosthesis 1 reinforcement portions 26 on, each on sections of the support arms 21 are provided which do not match the transition sections 23 between the two arms 21 two mutually adjacent headband 20 to match.

10 shows a planar projection of a cutting pattern, which in the production of a further preferred embodiment of the self-expandable endoprosthesis 1 is applicable to cut an endoprosthesis integrally from a metal tube. This in 10 illustrated pattern distinguishes from the im 1e illustrated pattern in that on the one hand to the distal, in the respective brackets 21 in the longitudinal direction of the headband 21 running slots 24 was dispensed with, while on the other hand between the adjacent brackets 21 a larger gap 27 cut out, in particular to save material.

In 11 is another preferred embodiment of a self-expanding endoprosthesis 1 for an alternative realization of the medical device according to the invention. In detail, the endoprosthesis 1 the further preferred embodiment according to 11 assumed its second shape, in which the medical device is in its expanded state another embodiment of the endoprosthesis 1 represented for the medical device according to the invention. In particular, this is an endoprosthesis 1 which is present in its second shaping, ie after triggering the shape memory effect.

The endoprosthesis 1 according to 11 is different from the endoprosthesis 1 according to 1c in that at the stent 1 according to 11 between the eyelets 30 and the transition section 13 between the position arms 11 two adjacent position brackets 10 a substantially in the longitudinal direction of the endoprosthesis 1 extending gutter 16 is provided, reducing the total length of the endoprosthesis 1 and thus the medical device is enlarged. For the purpose of optimal maneuverability of the medical device in the folded state, however, it is advantageous if the endoprosthesis 1 has as small a longitudinal extent as possible, in particular when the implantation path leads to the heart valve through the aortic arch, wherein to cope with this bend the shortest possible medical device (and thus as short as possible endoprosthesis 1 ) is advantageous.

Furthermore, the endoprosthesis differs 1 according to 11 from the endoprostheses of the embodiments described above in that now in the expanded state of the endoprosthesis 1 at the respective transitional sections 23 between the two arms 21 two mutually adjacent headband 20 a through the slots 24 formed barb section 25 protrudes radial direction, the tip in the direction of the distal retention area 2 the endoprosthesis 1 shows.

Hereinafter, the use of the medical device according to the invention for the treatment of aortic valve insufficiency based on 12a and 12b described in more detail.

The medical device according to the present invention, and in particular the endoprosthesis 1 with the heart valve prosthesis located therein 40 is designed to be inserted either retrograde or transapical, ie from the apex of the heart, via a special catheter into the patient's body, placed percutaneously orthotopic in vivo, and to function as an insufficient or stenosed native aortic valve. In 12a schematically shows a possible implantation process for the medical device according to the present invention, in which case the medical device with a special catheter is introduced retrograde into the body of the patient. In 12b In a schematic view, the medical device according to the present invention is shown in the implanted state.

At the in 12a via the puncture of the common femoral artery (inguinal artery) 12a not shown in detail special catheter system introduced the medical device with the heart valve prosthesis 40 and the endoprosthesis serving as anchoring stent 1 includes. This catheter system is preferably demonstrated under angiographic (vascular imaging) and echocardiographic (ultrasound) control to the aortic valve position. Here then the actual heart valve implantation takes place.

Alternatively, a special catheter system can be inserted transapically from the apex of the heart through the left ventricle to the aortic valve. Here is an analogous implantation of the endoprosthesis with a correspondingly modified catheter tube 1 with the heart valve prosthesis 40 possible.

Preferably, during the demonstration of the special catheter system, the medical device is appropriately cooled, for example, by rinsing the special catheter system with a suitable coolant, such as saline. When the medical device has been advanced to the desired site of implantation, cooling is discontinued resulting in the endoprosthesis 1 the medical device is heated to the body temperature (36 ° C) of the patient and thus the Formgedächniseffekt the Endoprothesenmaterials is triggered.

Due to the self-expanding property of the endoprosthesis triggered thereby 1 Radial forces develop on the individual components of the endoprosthesis 1 , and in particular at the respective position brackets 10 . 11 and brackets 20 . 21 the endoprosthesis 1 attack. Because the endoprosthesis 1 the medical device is still in the Einführkathetersystem, which are developing after exceeding the critical switching temperature and the individual components of the endoprosthesis 1 attacking radial forces are still compensated by the introducer sheath of Einführkathetersystems, so that - despite triggering the Formgedächniseffekts - the endoprosthesis 1 the medical device is constrained in its first (folded) shape.

By a suitable gradual release of the endoprosthesis 1 from the Einführkathetersystem then the position bar 10 . 11 the endoprosthesis 1 discharged from the introducer sheath of the delivery catheter system. The position brackets 10 . 11 tension due to the attacking radial forces in the radial direction span. The clamped position brackets 10 . 11 then be in your pockets 50 the native heart valve 51 positioned.

Subsequently, the remaining components of the endoprosthesis 1 or the medical device released from the introducer sheath of Einführkathetersystems. As in 12b shown, thereby tension the headband 20 . 21 in the radial direction and thus unfold umbrella-like on the brackets 20 . 21 , for example with the help of a thread 41 etc., attached heart valve prosthesis 40 , The on the brackets 20 . 21 but also at the distal retention area 2 the endoprosthesis 1 attacking radial forces cause the endoprosthesis 1 is pressed in the radial direction against the vessel wall, which on the one hand a secure anchoring of the medical device in the implantation site and on the other hand, a reliable seal the heart valve prosthesis 40 at the proximal retention area 3 the endoprosthesis 1 guaranteed.

In the in 12b illustrated implanted state of the medical device is the heart valve prosthesis 40 at the proximal retention area 3 the endoprosthesis 1 stretched while at the same time the old (insufficient) heart valve 51 due to the self-expanding nature of the endoprosthesis 1 pressed against the vessel wall. The distal retention area of the endoprosthesis 1 provides additional mechanical support to the system and secure anchoring.

In detail is based on the 12b to recognize that in the expanded state of the endoprosthesis 1 the respective position arms 21 the position bracket 20 in the pockets 50 the diseased heart valve 51 engage and thus ensure a safe and accurate positioning of the medical device. On the other hand, the pocket flaps of the diseased heart valve 51 due to the expansion of the endoprosthesis 1 between the position bars 10 and the brackets 20 clamped, which in addition to optimal positioning also a stable anchorage of the proximal retention area 3 the endoprosthesis 1 located heart valve prosthesis 40 he follows. At the same time, an optimal lateral sealing of the implanted valve prosthesis 40 guaranteed.

Additional mechanical support of the system and secure anchoring can also be achieved by providing barbs 17 at the distal retention area 2 the endoprosthesis 1 provided eyelets 30 and / or by suitable anchoring posts 25 will be realized. The anchoring posts 25 stand in the expanded state of the endoprosthesis 1 from the associated arm 21 the headband 20 with their tip in the direction of the distal end 2 the endoprosthesis 1 shows.

Basically, the special design of the endoprosthesis 1 the possibility of using the eyelets 30 the endoprosthesis 1 subsequently recover and the medical device by longitudinal extension of the endoprosthesis 1 such that the medical device can be removed from the patient's body via a catheter tube, etc. again.

By a design-type integration of retaining elements (eyelets) on the self-expanding endoprosthesis 1 This can also be explanted again after implantation using a special catheter. This is the distal retention area 2 the endoprosthesis 1 retracted at several stops by guidewires in a catheter. Here, in contrast to the implantation, the endoprosthesis 1 stretched from its expanded state in the collapsed state and detached from the anchorage in the pockets of the actual heart valve.

In short, it should be noted that the solution according to the invention is due to a metal endoprosthesis 1 characterized by an approachable or sutured heart valve prosthesis that at Diseases of the aortic valve, which make a replacement of the old heart valve necessary to be used. The aortic valve stent 1 (the endoprosthesis) can be introduced retrograde via a special catheter system and thus placed percutaneously orthotopic in vivo and take over the function of the insufficient or stenosed native aortic valve. Due to the self-expanding property of the endoprosthesis 1 developed radial forces guarantee a secure anchoring in the area of the aorta.

Specifically, a medical instrument consisting of an endoprosthesis 1 for positioning and fixing a heart valve prosthesis in the aorta of the patient is specified for the treatment of aortic valve insufficiency, wherein an endoprosthesis specially developed on the basis of Nitinol 1 is provided for receiving a prosthetic heart valve for implantation in the aorta. The ready-to-use medical device according to the invention consists of the components self-expandable nitinol stent 1 with flap-bearing segment 20 , Flap and system to introduce to the desired places in the body.

With regard to the design of the endoprosthesis 1 It is provided that three position brackets for positioning and fixing the medical device in the vessel of the patient and holding webs for receiving / attaching the heart valve prosthesis are provided, for example by means of a thread. In functional terms, the endoprosthesis 1 high radial forces in their second shape to ensure the anchoring of the medical device in the aorta. Preferably, at the distal retention area of the endoprosthesis 1 or the medical device eyelets 30 provided, which can be brought into a releasable engagement with corresponding components of a Einführkathetersystems.

Preferably serves to trigger of the shape memory effect of for the endoprosthesis used material a switching temperature, the between 20 ° C and 36 ° C and preferably at 22 ° C lies. In the cooled state is thus the medical device via, for example, a 21F delivery system in the body the patient can be introduced.

With regard to the exact dimensioning of the endoprosthesis 1 It is envisaged that these serve to receive heart valve prostheses with a valve diameter of 21 mm to 25 mm, with the secure anchoring of the medical device in particular the distal retention area 2 the endoprosthesis 1 has a diameter that is about 10% to 15% higher.

Preferably has the medical invention Device a good radiopacity of the Endoprosthesis, which may be by attaching markers to the proximal and / or distal region of the endoprosthesis is achievable.

As used materials for the endoprosthesis 1 Use implant-proven materials such as nitinol and tantalum. With regard to the dimensioning of the endoprosthesis, two different stent sizes are currently preferred, which are given in the following table together with the diameter of the proximal retention area and the distal retention area.

By a suitable aftertreatment, in particular tempering, can be - starting Of the two currently preferred stent sizes - other dimensions of the Realize stents.

The Invention is not related to those in the figures illustrated preferred embodiments limited features described. Rather, all are Combinations of the features specified in the specification conceivable.

Claims (21)

A medical device for the treatment of aortic valve insufficiency, comprising a self-expanding endoprosthesis that can be inserted minimally invasively into the body of a patient ( 1 ) for positioning and fixing a heart valve prosthesis in the aorta of the patient, wherein the endoprosthesis ( 1 ) at least three position brackets ( 10 . 11 ) for independently positioning the medical device in the aorta of the patient ducks and a retaining segment with retaining clips ( 20 . 21 ) for receiving a heart valve prosthesis, and wherein the endoprosthesis ( 1 ) during introduction of the medical device into the body of the patient has a first pre-definable shape and in the implanted state of the medical device, a second pre-definable shape, wherein the medical device in the first shape of the endoprosthesis ( 1 ) in a folded state and in the second shape of the endoprosthesis ( 1 ) is in an expanded state, characterized in that the endoprosthesis ( 1 ) has an integrally cut from a metal tube structure in which each position bracket ( 10 . 11 ) a headband ( 20 . 21 ) and at which at the distal end ( 2 ) of the endoprosthesis ( 1 ) each end section ( 13 ) of the respective position bracket ( 10 . 11 ) with the end section ( 23 ) of the associated holding bracket ( 20 . 21 ) connected is. A medical device according to claim 1, wherein each position bracket ( 10 . 11 ) and its associated headband ( 20 . 21 ) each have a substantially U-shaped or V-shaped structure, which leads to the proximal end ( 3 ) of the endoprosthesis ( 1 ) is closed. Medical device according to claim 2, wherein each position bracket ( 10 . 11 ) is cut from the material portion of the metal tube, of the substantially U- or V-shaped structure of the associated retaining clip ( 20 . 21 ) is recorded. Medical device according to one of the preceding claims, wherein the end section ( 13 ) of each position bracket ( 10 . 11 ) in each case one substantially in the longitudinal direction of the endoprosthesis ( 1 ) extending connecting web ( 15 ) with the end section ( 23 ) of the associated holding bracket ( 20 . 21 ) connected is. Medical device according to one of the preceding claims, wherein the endoprosthesis ( 1 ) at its distal end ( 2 ) further fastening means ( 30 ) which are engageable with an introducer catheter system. Medical device according to claim 5, wherein the fastening means ( 30 ) one each between two adjacent position bars ( 10 . 11 ) ( 30 ), wherein the respective arms ( 11 ) of the adjacent position bracket ( 10 . 11 ) on the one hand and the respective arms ( 21 ) to the adjacent position bars ( 10 . 11 ) associated retaining clips ( 20 . 21 ) on the other hand with the attachment eye ( 30 ) are connected. A medical device according to claim 6, wherein the respective arms ( 11 ) of the adjacent position bracket ( 10 . 11 ) directly and the respective arms ( 21 ) to the adjacent position bars ( 10 . 11 ) associated retaining bracket ( 20 . 21 ) indirectly over a substantially longitudinal direction of the endoprosthesis ( 1 ) extending connecting web ( 15 ) with the attachment eye ( 30 ) are connected. A medical device according to claim 6, wherein the respective arms ( 11 ) of the adjacent position bracket ( 10 . 11 ) indirectly over a substantially longitudinal direction of the endoprosthesis ( 1 ) extending connecting web ( 16 ) with the attachment eye ( 30 ) and the respective arms ( 21 ) to the adjacent position bars ( 10 . 11 ) associated retaining bracket ( 20 . 21 ) indirectly over a substantially longitudinal direction of the endoprosthesis ( 1 ) extending connecting web ( 15 ) with the attachment eye ( 30 ), wherein the connecting bridge ( 15 ) the headband ( 20 . 21 ) at the end section ( 13 ) the position bracket ( 10 . 11 ) in the connecting bridge ( 16 ) the position bracket ( 10 . 11 ) passes over. Medical device according to one of claims 6 to 8, wherein the between two adjacent position brackets ( 10 . 11 ) ( 30 ) with at least one barb ( 17 ) whose tip is in the direction of the proximal end ( 3 ) of the endoprosthesis ( 1 ). Medical device according to one of the preceding claims, wherein the respective arms ( 21 ) the headband ( 20 . 21 ) each an anchoring support ( 25 ) in the form of a bracket which in the expanded state of the endoprosthesis ( 1 ) of the associated arm ( 21 ) the headband ( 20 . 21 ) and their tip in the direction of the distal end ( 2 ) of the endoprosthesis ( 1 ). Medical device according to claim 10, wherein the anchoring support ( 25 ) has a substantially U-shaped or V-shaped structure, which leads to the distal end ( 2 ) of the endoprosthesis ( 1 ), the distal region of the anchor support ( 25 ) the tip of the anchoring support ( 25 ), and wherein the respective arms of the anchoring support ( 25 ) at the proximal end of the anchoring support ( 25 ) with the respective poor ( 21 ) of two adjacent retaining clips ( 20 . 21 ) are connected. Medical device according to one of the preceding claims, in particular according to one of claims 1 to 9, wherein in the respective retaining clips ( 20 . 21 ) in the longitudinal direction of the headband ( 20 . 21 ) running slots ( 24 ), which are designed, the second shape of the endoprosthesis ( 1 ) to influence. Medical device according to claim 12, wherein the respective retaining clips ( 20 . 21 ) Reinforcing sections ( 26 ), which in the longitudinal direction of the headband ( 20 . 21 ) extending slots ( 24 ) interrupt. Medical device according to one of the preceding claims, wherein the endoprosthesis ( 1 ) in its first shape has an outer diameter of about 5.0 mm and a length of between 33.0 mm to 40.0 mm, preferably between 34.0 to 39.0 mm, and more preferably between 34.37 mm and 38.37 mm. Medical device according to one of the preceding claims, wherein in the second shaping of the endoprosthesis ( 1 ) the endoprosthesis ( 1 ) a slightly concave, towards the proximal retention area ( 3 ) of the endoprosthesis ( 1 ) has a tapered design. Medical device according to claim 15, wherein in the second shaping of the endoprosthesis ( 1 ) the distal retention area ( 2 ) of the endoprosthesis ( 1 ) has a diameter which is approximately 10% to 25% greater than the diameter of the proximal retention area ( 3 ) of the endoprosthesis ( 1 ). Medical device according to claim 15 or 16, wherein in the second shaping the proximal retention area (FIG. 3 ) of the endoprosthesis ( 1 ) has a diameter between 22 mm to 33 mm, preferably between 25 mm to 31 mm. A medical device according to any one of the preceding claims, further comprising a heart valve prosthesis ( 40 ), preferably a Bioherzklappenprothese, which at the retaining clips ( 20 . 21 ) of the endoprosthesis ( 1 ) by means of a thread ( 41 ) or the like is mounted such that the heart valve prosthesis ( 40 ) in the second shape of the endoprosthesis ( 1 ) with the respective arms ( 21 ) the headband ( 20 . 21 ) at the proximal end ( 5 ) of the endoprosthesis ( 1 ) is stretched. Medical device according to one of the preceding claims, wherein the endoprosthesis ( 1 ) consists of a shape memory material, so that the endoprosthesis ( 1 ) is deformable under the action of an external stimulus of a temporary shape to a permanent shape, wherein the temporary shape of the first shaping of the endoprosthesis ( 1 ) and the permanent shape in the second shape of the endoprosthesis ( 1 ) is present. The medical device of claim 19, wherein the external stimulus is a definable switching temperature. The medical device of claim 20, wherein the switching temperature in the range between the room temperature and the body temperature the patient and preferably at about 22 ° C.