DE102007005992A1 - Catheter for heart valve valvuloplasty, resection and consecutive implantation of a heart valve stent - Google Patents

Abstract

Catheter for heart valve valvuloplasty and / or heart valve implantation with a proximally disposed section (9) having an inlet opening (10), a distally arranged section having an outlet opening (8) and a medially arranged inlet opening (10) with the outlet opening (8). connecting, a cavity-forming portion (7), characterized in that the wall of the medial portion (7) is formed elastically and adapted to receive an expandable valve stent (16).

Description

The The invention relates to a catheter for valvular valvuloplasty and / or heart valve implantation. In particular, the invention relates a catheter for heart valve valvuloplasty, himself subsequent flap resection and consecutive Implantation of a new foldable heart valve stent. The invention further relates to a catheter system that allows the method to perform on the beating patient's heart.

Of the Surgical valve replacement is currently on cardioplegic (heart-stopping) hearts performed (Golden Standard). The diseased heart valve is usually cut out and The heart valve prosthesis to be implanted is sewn in.

These elaborate method is obligatory under the help of heart-lung machines and is used for high-risk patients Part out of the question, so after minimally invasive or percutaneous Methods for replacing a heart valve was sought.

So is out of the DE 195 46 692 C2 or in EP 1 469 797 B1 a self-expandable heart valve prosthesis for implantation in the human body via a catheter system with a heart valve and with a collapsible and expandable stent connected to the heart valve known.

A Such self-expanding heart valve prosthesis can with the help of a Catheter system through a groin artery up to the implantation site be guided by the heart. After reaching the implantation site can then be such a stent, in its longitudinal direction from a plurality of self-expanding relatively bendable Segments is gradually unfolded. To Unfolding can also assist the heart valve prosthesis anchoring hook at least in the heart near the respective blood vessel anchored. The actual heart valve prosthesis is located while in the proximal portion of the stent.

Another device for securing and anchoring heart valve prostheses is in the DE 100 10 074 A1 described, which is formed essentially of wire-shaped interconnected elements. Various brackets are used here to achieve a secure attachment and support of a heart valve.

at However, these known solutions there is a risk Fehlimplantation of Herklappen in the exact positioning and the angular orientation of the heart valve prostheses to be implanted.

Improved positioning and angular alignment with the aortic valve can be achieved through the stent 's stent EP 1 469 797 B1 be achieved, are formed in the so-called support bracket, which are insertable into the aortic pockets and thus produce a defined distance to the aortic valve.

The aim is the individual 3D valve stent, which is made with the help of interventionally obtained data from an imaging procedure before implantation accurately herge (see. US 6,790,230 B2 ). This valve stent conforms to the shape of the aortic bulb, the aorta ascendens and the annulus with a recess of the coronary nerves.

One much bigger problem for the optimal Placement of the new heart valve in the stent (or valve stent) is however, that's the old native flap in most cases the implantation technique described above should not be removed.

By leaving the native aortic valve, in severe calcifications or an unfavorable anatomy of the flap pockets to the coronary artery essentially five problems occur:
The unprotected valvuloplasty, which often precedes implantation, can potentially cause embolism from dissolving lime particles. The consecutive implantation of a heart valve stent leads to a displacement of the native valve in the direction of the annulus, which may lead to a transfer of the coronary artery, on the other hand, it can lead to paravalvular leaks, if there are large calcareous islands of the native valve between annulus and valve stent. In addition, the displacement of the aortic annulus along with the calcifications during implantation can lead to the development of mitral valve insufficiency. Finally, excess, possibly calcified tissue in the annulus leads to a reduction in the effective aortic valve opening area, which means that the implanted valve is too small and it can thus come in the long term again to a stenotic problem.

For the process of heart valve resection, however, is from the WO 93/01768 a catheter system for minimally invasive intravascular aortic valve extraction on beating heart is known, which has a working capsule at the proximal end, which in turn describes a foldable screen-like screen element. This is located downstream in the bloodstream and is intended to capture the aortic valve fractures arising from the extraction performed with a rotating knife.

A similar catheter arrangement describes US 5,855,601 , Here, a local heart valve ablation using a hollow catheter system is shown. A proximal dilateable receiving unit that attaches distally to the aorta. The extraction takes place with a cutting tool, which in turn still has an inflatable protective balloon at the proximal end.

In US 2005/0717472 A1 and DE 102 17 559 B4 2004.02.19 a catheter system is described, which envisages the extraction of the heart valve not under X-ray control, but under direct view contrary to the previous inventions. For this, an operating room is erected around the aortic valve by means of a supravalvular and subvalvular dilatation unit, which has a perfusion space which leads the bloodstream separately through the operating room. Again, the extraction should be done on the beating heart.

The Carrying out the operation with the known catheter systems However, it is very laborious and time consuming and it must regularly use different catheters valvuloplasty and subsequent resection become.

task The invention therefore, a catheter for valvuloplasty and to create a catheter system with the help of which Diseased heart valve via a percutaneous access below protected measures and subsequently should be removed. The valve annulus should therefore be surgically so far be prepared that a new heart valve stent with the same System can be implanted.

The Task is solved by a catheter with the features of claim 1 and by a catheter system having the features of Claim 5. The dependent claims each give advantageous Further developments of the devices according to the invention at.

Of the The invention is based on the idea of an expandable hollow catheter system for combined screening and valvuloplasty and implantation to create the aortic valve of the entire cardiovascular system.

These is achieved by the fact that in the proximal third of the conical shaped tip of the hollow catheter system special openings are located. At the passage of the aortic valve (to install the subvalvular shielding), a suction is created there, so that resulting debris is aspirated because at this time there is no complete isolation of the aortic valve. Meanwhile, the valve stent to be implanted is located in a "parking position" in the resection catheter system After resection, the resection inlay is placed against the implantation inlay exchanged without requiring a complete system change would.

The Invention will be described below with reference to particularly preferred embodiments closer to their use in surgery on the patient's heart explained. Show it:

1a a sectional schematic side view of a particularly preferred embodiment of the catheter system according to the invention in the starting position before performing the valvuloplasty in situ;

1b a schematic side view of the catheter system with the partially extended catheter according to the invention;

2a a schematic side view of the catheter system in an advanced phase of the surgical procedure with supravalvular sealing;

2 B a schematic side view of the catheter system when passing through the region of the aortic valve;

2c a schematic side view of the catheter system in an advanced phase of the procedure;

2d a schematic side view of the catheter system after subvalvular sealing;

3a a schematic side view of the catheter system with inflated dilating unit with expanded valve stent and elastically expanded medial catheter section;

3b a schematic side view of the catheter system with deflated dilatation and extended Resektionsinstrument;

3c a schematic side view of the catheter system with retracted proximal portion;

3d a schematic side view of the catheter system with the introduced into the aortic valve medial portion of the catheter according to the invention with valve stent while maintaining the blood flow;

4a a schematic side view of the catheter system with unilaterally partially resected valve leaflets;

4b a schematic side view of the catheter system with bilateral partially resected sail;

4c a schematic side view of the catheter system with arranged in the aorta, partially inflated sealing device;

5a a schematic side view of the catheter system with arranged in the aorta, fully inflated sealing device;

5b a schematic side view of the catheter system with almost deflated sealing device and retracted catheter;

5c a schematic side view of the catheter system with incipient deployment of the heart valve stent;

5d a schematic side view of the catheter system in an advanced stage of the operation;

6a a schematic side view of the catheter system with implanted heart valve stent and closed flap;

6b a schematic side view of the implanted heart valve stent and open flap;

7 a schematic side view of a particularly preferred embodiment of the catheter system;

8a a schematic side view of another particularly preferred embodiment of the catheter system;

8b a semi-transparent side view of the representation 8a ;

8c a schematic plan view of the system 8a ;

9a a schematic side view of the catheter system according to the invention in transapical operation method in a first position;

9b a schematic side view of the catheter system according to the invention in transapical operation method with partially extended subvalvular sealing device;

9c a schematic side view of the catheter system according to the invention in transapical operation method when guided through the aortic valve catheter;

9d a schematic side view of the catheter system according to the invention in transapical operation method with extended supravalvular sealing device;

9e a schematic side view of the catheter system according to the invention in transapical operation method with fluid-tight by a supravalvular and subvalvular sealing device formed aortic valve insulation chamber;

10a a schematic semitransparent side view of the catheter system according to the invention in transapical operation method with dilated medial section;

10b a schematic side view of the catheter system according to the invention in transapical operation method with retracted proximal portion;

11 a schematic side view of the catheter system according to the invention in transapical operation method when introducing the Resektionswerkzeugs;

12a a schematic side view of the catheter system according to the invention in transapical operation method with advanced into the aorta deflated balloon;

12b a schematic side view of the catheter system according to the invention in transapical operation method with advanced into the aorta inflated balloon;

13a a schematic side view of the catheter system according to the invention in transapical operation method with advanced into the aorta, partially deflated balloon and degraded aortic valve isolation chamber;

13b a schematic side view of the catheter system according to the invention in transapical operation method during diastole with inflated balloon;

14a a schematic side view of the catheter system according to the invention in transapical operation method with incipient heart valve stent implantation;

14b a schematic side view of the catheter system according to the invention in a transapical surgical method in an advanced phase;

14c a schematic side view of the catheter system according to the invention in transapical operation method with implanted heart Fold stent;

14d a schematic side view of the catheter system according to the invention in transapical operation method with implanted heart valve stent and balloon withdrawn;

The 1 - 6 show by way of example a particularly preferred ausgestaltetes catheter system in each case a plurality of schematic side views in situ. The aorta, the left coronary artery 3 and the right coronary artery 4 , Aortic valve 2 , as well as myocardium M and mitral valve MK are merely indicated for clarification of the position of the catheter in the patient's heart. In addition, an ECG belonging to the respectively illustrated intervention phase is shown in each image at the lower edge of the image.

In 1a the catheter system is already using the guidewire 5 introduced into the ascending aorta, the guidewire 5 already through the aortic valve 2 is placed in the left ventricle and a normal sinus rhythm 6 consists.

1b shows the also claimed with the appended claims catheter in the catheter system proximally, ie in the direction of the heart, from a working channel of the first catheter 1 is advanced. This catheter, referred to as a second catheter in the catheter system, consists of a proximally arranged, one or more inlet openings 10 having section 9 , which is cone-shaped in the example shown. The conical structure facilitates passage through the aortic valve 2 , Furthermore, the second catheter has a distally arranged outlet opening 8th and one the inlet opening 10 with the outlet opening 8th connecting medial section 7 on. The medial section 7 is specially designed such that the medial section 7 one the communication between inlet opening 10 and outlet opening 8th forming void, wherein the wall of the medial portion is formed elastically and adapted to receive an expandable valve stent. The function of the medial section will be discussed in detail below.

The 2a - 2d show progressively the installation of the aortic valve isolation chamber in a side view similar to that in FIG 1b shown view. The sealing device arranged proximally on the first catheter 11 (supravalvular sealing device) is after induction of ventricular fibrillation 12 below the coronary ostia 3 . 4 arranged. Supravalvular inside the aortic valve isolation chamber, a suction is applied to the suction ports of the proximal portion of the second catheter. Through the medial section, the bloodstream should run during the resection. The dilatation unit is positioned within the medial section (see 2a ). With increased suction, the medial section is then guided through the aortic valve with the help of the conical structure of the proximal section. Lime particles are sucked out via the inlet opening.

While the ventricular fibrillation continues ( 2 B ), the second catheter is further advanced until the second sealing means 14 (Subvalvular sealing device) the aortic valve 2 completely happened. Subsequently, the suction is through the inlet opening 10 again reduced ( 2c ).

In the next step, the second sealing device 14 unfolded and the second sealing catheter pulled back so far until the second sealing device seals subvalvular ( 2d ).

3a - 3d show the protected valvuloplasty in the aortic valve isolation chamber dilating the dilatation unit 13 , Insufflation of the dilatation unit 13 urges the calcified tissue to the edge and resulting lime particles accumulate inside the subvalvular sealing device 14 ( 3a ). After the valvuloplasty becomes the dilatation unit 13 removed and the resection tool 15 demonstrated ( 3b ).

Following is the proximal section 9 of the second catheter into the first catheter 1 withdrawn and in the medial section 7 arranged, by means of the dilation unit 13 expanded interim flap 16 and the exit opening 8th Approved ( 3c ). On it becomes the proximal section 9 that with the medial section 7 preferably releasably connected, with the guide wire 5 removed and the blood can pass freely through the medial section and to the outlet opening 8th after heart synchronization, flow into a normal sinus rhythm (see 3d ).

Alternatively to an interim flap 16 may according to a preferred embodiment, the dilation unit 13 assume the valve function when the dilation unit 13 in the area of an expanded stent without an interim valve 16 is formed, remains and is arranged such that the dilation unit 13 during the systole of the patient's heart is deflated and inflated during the diastole of the patient's heart. This can be done, for example, by the rhythmic widening and contracting of the dilation unit 13 triggered by an ECG signal.

4a - 4c show the resection passageway of the aortic valve 2 , The resection tool 15 initially resect the left coronal sail in the of the sealing devices 11 . 14 formed aortic valve isolation chamber ( 4a ). Gradually, the akoronary and right coronary valve leaflets are resected. After completion of the resection, the resection tool is withdrawn and the further sealing device 18 on the first catheter 1 distally, begins with the rhythmic inflation / deflation following diastole / systole ( 4c ).

5a - 5d show the uninstallation of the aortic valve isolation chamber by folding the supravulvular sealing device 11 and the subvalvular Dichtungseinrich device 14 and the increasing inflation of the further sealing device 18 ( 5a ). The sealing device 18 is deflated in systole and insufflated in diastole; this can be triggered, for example, by an ECG signal. The one in the working channel of the first catheter 1 arranged second catheter is withdrawn after the medial section 7 with its elastic wall back to the initial state and thus also the interim valve stent 16 from its expanded state to the collapsed state. In 5b is the second catheter in the working channel of the first catheter 1 completely withdrawn and the other sealing device 18 to recognize in deflated condition. The following picture 5c shows the beginning implantation of the aortic valve stent 19 , In this case, the further sealing device 18 insufflated. The heart valve stent 19 will continue from the first catheter 1 guided and unfolded, being in 5d already the flap 20 you can see. The further sealing device is deflated.

6a - 6b show the implantation by means of the catheter system according to the invention of a specially adapted to the anatomy of the aortic bulb aortic valve stent 19 with heart valve 20 , In 6a the heart valve is closed. The system according to the invention is now removed. The following 6b shows the opened heart valve.

The catheter system according to the invention is preferably designed such that the sealing devices 11 . 14 are designed umbrella-like for the establishment of an aortic valve insulation chamber. It can be provided at these free-ends suction channels in these devices, so that the sealing means 11 . 14 can be sucked to the heart tissue, to ensure that the aortic valve isolation chamber is unaffected by the blood stream.

Furthermore, it is preferably provided that the permanently implanted heart valve stent 19 in an annular channel in the first catheter 1 is introduced. This makes it possible to perform the valvuloplasty, resection and implantation of a new heart valve with only one catheter.

7 shows the side view of another embodiment, the an alternating arrangement of Blutauslassöffnungen 8th and working channels for multiple resection instruments 15 having. In order to achieve a circular resection, the resection instruments must each be demonstrated in the adjacent working channel (turret principle). Furthermore, the supra-and subvalvular sealing device is preferred 11 . 14 with an additional membrane 21 provided an improved seal between the sealing devices 11 and 14 and reach the valve annulus.

8a - 8c show a side view of another embodiment. Here is a central guide 22 provided that connects the system to the aortic valve isolation chamber. At the guide 22 is the medial section 7 attached. The blood flow 17 The aortic valve isolation chamber also passes unhindered here. The resection instruments 15 be over a sealing gutter 23 introduced, and so can circular the flap 2 resect ( 8a ). The illustration 8b shows a semitransparent representation of the embodiment 8a , The resection instruments 15 can each turn almost 180 ° around the guide 22 to be turned around. In the plan view can be seen that the seal groove 23 in two places in each case by a bridge 24 is interrupted, which serves to stabilize the sealing device ( 8c ). An advantage over the other modifications is the improved blood flow during the resection.

However, the system according to the invention can also be used for transapical resection, that is to say via access via the apex of the heart. This use is in the 9a - 9d shown, wherein the further dilation unit for sealing the aorta as another tool through the first catheter 1 is guided. For the most part, reference may be made to the above description, with the difference that the first sealing device 11 of the first catheter 1 now the subvalvular sealing device and the second sealing device 14 of the second catheter represents the supravalvular sealing device. Another difference is that the outlet opening 8th mm functionally as inlet and the inlet opening 10 now functionally used as an outlet.

9a shows the catheter system according to the invention at the time of incipient passage of the proximal portion 9 through the aortic valve 2 ( 9a ). Before complete passage of the aortic valve becomes the subvalvular sealing unit 14 unfolds and the blood outlet 8th open ( 9b ). The following are: advancing the medial section 7 of the second catheter and the proximal portion 9 ( 9c ), Unfolding the subvalvular sealing device 11 and sealing the aortic valve by the subvalvular and supravalvular sealing means 11 . 14 ( 9d ). In addition, the installation of a separate supravalvular sealing unit via a peripheral access (eg, BA femoris communis) is useful to prevent embolism during passage through the aortic valve.

10a - 10b show the expansion of the medial section ( 10a ). It follows the retraction of the proximal portion 9 of the second catheter and the release of the bloodstream. It shows the sealed resection chamber ( 10b ).

11 shows the introduction of the resection instrument 15 ,

12a - 12b show the installation of the additional tool designed as a balloon 18 in the aorta ascendens in the deflated ( 12a ) and inflated state ( 12b ) which is controlled as described above for the further sealing device.

13a - 13b show the withdrawal of the aortic valve isolation chamber.

Finally show 14a - 14d the beginning implantation ( 14a ) of the aortic valve stent 19 until complete implantation ( 14b . 14c ) and withdrawal of the balloon 18 and the catheter system ( 14d ).

1

first catheter

2

aortic valve

3

left coronary artery

4

right coronary artery

5

guidewire

6

Sinus rhythm ECG

7

media Section of the second catheter

8th

outlet

9

proximal Section of the second catheter

10

inlet port

11

first Sealing device (on the first catheter)

12

Ventricular fibrillation ECG

13

dilation

14

second Sealing device (on the second catheter)

15

Resektionswerkzeug

16

valve stent

17

blood flow

18

Further Sealing device (on the first catheter)

19

Aortenklappenstent

20

leaflets

21

specific seals

22

central guide

23

seal grooves

24

supravalvular Sealing device web

MK

mitral valve

M

myocardium

QUOTES INCLUDE IN THE DESCRIPTION

This list The documents listed by the applicant have been automated generated and is solely for better information recorded by the reader. The list is not part of the German Patent or utility model application. The DPMA takes over no liability for any errors or omissions.

Cited patent literature

• - DE 19546692 C2 [0004]
• - EP 1469797 B1 [0004, 0008]
• - DE 10010074 A1 [0006]
• - US 6790230 B2 [0009]
• WO 93/01768 [0012]
• US 5855601 [0013]
• US 2005/0717472 A1 [0014]
• - DE 10217559 B4 [0014]

Claims (14)

Catheter for heart valve valvuloplasty and / or heart valve implantation with a proximal, an inlet opening ( 10 ) ( 9 ), a distally located, an outlet opening ( 8th ) and a medial arranged, the inlet opening ( 10 ) with the outlet opening ( 8th ) connecting a cavity-forming section ( 7 ), characterized in that the wall of the medial section ( 7 ) elastically and for receiving an expandable valve stent ( 16 ) is set up. Catheter according to claim 1, characterized in that the medial portion ( 7 ) a substantially centrally arranged, inflatable dilatation unit ( 13 ) for the expansion of the valve stent ( 16 ) having. Catheter according to claim 1, characterized in that the medial portion ( 7 ) a substantially centrally arranged, inflatable dilatation unit ( 13 ) adapted to take a substantially deflated state during systole of the patient's heart, and to assume a substantially inflated state during diastole of the patient's heart. Catheter according to one of the preceding claims, characterized in that the medial section ( 7 ) is releasably connected to the proximal portion. Catheter according to one of the preceding claims, characterized in that the medial section ( 7 ) at its proximal end a screen-like distally extending sealing device ( 14 ) having. Cardiac valve valvuloplasty catheter system comprising - a first catheter ( 1 ) with - a first distally arranged sealing device ( 11 ), - a working channel; and - one into the working channel of the first catheter ( 1 ) insertable second catheter ( 7 ) with - a proximal, an inlet opening ( 10 ) ( 9 ), - a distally arranged, an outlet opening ( 8th ), - a medial arranged, the inlet opening ( 10 ) with the outlet opening ( 8th ) connecting a cavity-forming section ( 7 ), - and one between the distal and medial sections ( 7 ) arranged second sealing device ( 14 ), - where the wall of the medial section ( 7 ) elastically and for receiving an expandable valve stent ( 16 ) is set up. Catheter system according to claim 6, characterized in that the first catheter ( 1 ) a further, distally arranged sealing device ( 18 ) having. Catheter system according to one of claims 6 and 7, characterized in that the further sealing device ( 18 ) a balloon ( 18 ). Catheter system according to claim 8, characterized in that the catheter system is set up such that the balloon ( 18 ) undergoes a substantially deflated state during systole of the patient's heart and a substantially inflated state during diastole of the patient's heart. Catheter system according to one of claims 6 to 9, characterized in that the first and / or the second sealing device ( 11 . 14 ) are formed umbrella-like and cooperative to form a common cavity. Catheter system according to one of claims 6 to 10, characterized in that the first and / or the second sealing device ( 11 . 14 ) is arranged at its free end for sucking on tissue. Catheter system according to one of claims 6 to 11, characterized in that the first catheter ( 1 ) at least one further working channel for receiving a heart valve resection tool ( 15 ) having. Catheter system according to one of claims 6 to 12, characterized in that the first catheter ( 1 ) for receiving a permanently implantable heart valve stent ( 19 ) is set up. Catheter system according to claim 13, characterized in that the first catheter ( 1 ) an annular channel for receiving the heart valve stent ( 19 ) having.