SYSTEM AND METHOD FOR REPLACING AN INFLAMED OR INFECTED HEART VALVE

Abstract

The invention relates to a system for replacing a heart valve that is diseased owing to inflammation and/or an infection. The system has: a stent system with at least one expandable stent; and a replacement heart valve which is secured to the at least one stent and has at least two heart valve leaflets. The at least one stent has a coating with an antimicrobial substance or an antimicrobially effective carrier material, preferably on the inner side and/or the outer side.

Claims

1. A system for replacing an inflamed or infected valve of the heart, wherein the system comprises: a stent system including at least one expandable stent; a replacement heart valve secured to the at least one expandable stent and comprising at least two heart valve leaflets; and a coating of an antimicrobial substance or an antimicrobially active carrier material on an interior and/or exterior of the at least one expandable stent.

2. The system according to claim 1, wherein the coating of the at least one expandable stent is configured to be activated in a controlled manner subsequent to implantation of the at least one expandable stent.

3. The system according to claim 1, further comprising: a skirt region, wherein a first area of the skirt region is provided on the interior of the at least one expandable stent and a second area of the skirt region is provided on the exterior of the at least one expandable stent; and a chamber, wherein the chamber is configured to be filled with a second substance; is provided in or on the skirt region; and is configured such that the second substance accommodated in the chamber of the at least one expandable stent is releasable to surrounding tissue.

4. The system according to claim 3, wherein the chamber is configured in the skirt region in the first area on the interior side and/or in the second area on the exterior side of the at least one expandable stent.

5. The system according to claim 3, wherein the chamber is configured to be filled with the second substance prior to and/or during and/or subsequent to implantation of the at least one expandable stent.

6. The system according to claim 3, wherein the skirt region comprises a permeable membrane.

7. The system according to claim 3, wherein the chamber includes at least one fluidic connection to a contact area to tissue surrounding of the at least one expandable stent.

8. The system according to claim 3, wherein the second substance is the antimicrobial substance or comprises an antimicrobially active component.

9. The system according to claim 3, further comprising a catheter introduction apparatus configured for implanting of the at least one expandable stent.

10. The system according to claim 9, wherein the catheter introduction apparatus is configured for transapical or transfemoral introduction of the at least one expandable stent and the replacement heart valve secured thereto.

11. The catheter introduction system according to claim 9, wherein the catheter introduction apparatus comprises at least one channel detachably connected to the catheter introduction apparatus for filling the at least one chamber with the second substance.

12. The catheter introduction system according to claim 11, wherein the at least one channel is disengageably connected to the at least one chamber.

13. A method for replacing an inflamed or infected valve of the heart, comprising: providing a system including: a stent system further including at least one expandable stent; a replacement heart valve secured to the at least one expandable stent and comprising at least two heart valve leaflets; a coating of an antimicrobial substance or an antimicrobially active carrier material on the interior and/or exterior side of the at least one expandable stent; and a chamber fillable with a substance, provided in or on the skirt region and configured such that the substance accommodated in the chamber of the at least one expandable stent is releasable to surrounding tissue; implanting the stent system including at least one expandable stent into a diseased heart for the replacement of a diseased native or artificial heart valve; and filling the chamber with the substance prior to and/or during and/or subsequent to implantation of the at least one expandable stent.

14. The system according to claim 6, wherein the permeable membrane comprises a selectively permeable membrane.

15. The system according to claim 11, wherein filling the at least one chamber with the second substance is in the implanted state of the expandable stent and the replacement heart valve secured thereto.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0033] FIG. 1 is an example embodiment of the catheter introduction system with expanded stent with a replacement heart valve secured thereto;

[0034] FIG. 2 is a catheter introduction system with stent and affixed replacement heart valve in accordance with FIG. 1 in the implanted state in the heart;

[0035] FIG. 3 is a catheter introduction system with stent and affixed replacement heart valve in accordance with FIG. 2 after the chamber within the skirt region has been filled with at least one substance;

[0036] FIG. 4 is a further example embodiment of the inventive system in the form of an expanded stent with a replacement heart valve secured thereto.

DETAILED DESCRIPTION

[0037] In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. Other embodiments may be used and/or other changes may be made without departing from the spirit or scope of the disclosure.

[0038] The following will reference FIG. 1 in defining an example embodiment of the inventive system 2 in greater detail. FIG. 1 thereby shows the expanded state of the inventive system 2 comprising a stent 5, a replacement heart valve 3 having at least two leaflets 4 and a skirt region 6 provided in the ventricular retention area of the stent 5 on its interior and exterior side. A chamber 7 which can be filled with at least one substance is shown in the skirt region 6. The depicted catheter introduction system 1 has a catheter 12 with two channels 13 which establish a fluidic connection to the chamber 7 for this purpose.

[0039] The catheter introduction system in the depicted embodiment further comprises a balloon 10 for the balloon expansion of the stent 5 and a catheter tip 9. The stent 5 is expanded by a fluid being supplied to the catheter balloon 10 through an inner lumen of the catheter 12 so as to generate enough hydrostatic pressure for the balloon 10 to expand the stent 5. To this end, the catheter can be constructed from a plurality of layers or lumens respectively so as to provide the necessary functionality. Following the expansion of the stent 5, the balloon is compressed again so that the catheter can be removed from the vascular system of the patient at the conclusion of the operation.

[0040] The catheter 12 further constitutes a flexible catheter able to be guided through the vascular system of a patient, whereby the tip 9 can be controlled by control elements 15 so as to be able to be guided transfemorally to the heart. The control elements likewise serve in particular to control the inventive system in conjunction with the catheter introduction system, e.g. for disengaging the catheter 12 from the system 2 after the latter's successful implantation at the implantation site.

[0041] To fill the chamber 7 with at least one substance, channels 13 are connected to the chamber 7. The chamber 7 can thereby be in particular sequentially filled with a substance, in particular with a multi-component substance, particularly with different substances. The chamber 7 can furthermore be formed on the exterior and/or interior side of the stent 5. Once the chamber 7 has been filled, the channels 13 can be selectively disengaged from the system 2 by tractive force and/or by means of the control elements 15. The substance filled into the chamber 7 can be released therefrom into the blood of the patient via the remaining open connection points of the channels 13 or by means of diffusion of the substance through the skirt 6.

[0042] FIG. 2 illustrates the embodiment of the present invention according to FIG. 1 during implantation into a diseased heart 14. In detail, FIG. 2 depicts the expanded stent 5 with the replacement heart valve 2 secured thereto, whereby the insufficient native heart valve 11 is radially displaced by the expanded stent 5. FIG. 2 further illuminates that the length dimension of the system 2 of stent 5, replacement heart valve 2 and catheter introduction system 1 is limited so as to prevent contact with the endocardium of the heart and the heart muscle.

[0043] FIG. 3 illustrates the implantation of the system 2 according to FIG. 2, wherein the chamber 7 is filled with at least one substance. It is obvious that by the volumetric expansion of the chamber 7 when filled with at least one substance, the skirt 6 improves the paravalvular integrity in contact with the tissue of the insufficient native heart valve 11. It is in particular likewise possible for the chamber 7 to be filled and only a portion of the introduced substance released so that the substance remaining in the chamber 7 ensures the sealing function of the contact between the skirt 7 and the native heart valve 11. Particularly conceivable is for a substance of multiple components such as e.g. antimicrobial agents, antibiotics, anticoagulants and saline solution to be introduced into the chamber 7, whereby only a portion of the substance is capable of diffusing toward the blood past the permeable or selectively permeable skirt. The skirt 6 exhibits a specific flexibility and elasticity. A further possibility for the selective release of the introduced substance thereby ensues from a pressure-dependent release, wherein the introduced substance 6 is released until the chamber 7 reaches or drops below a hydrostatic pressure limit or the interior of the skirt 6 reaches or drops below a stress limit. The cited example embodiments can ensure the maintaining of a minimum volume in the chamber 7 and the paravalvular sealing function.

[0044] FIG. 3 further shows that a substance filled into the chamber 7 can enter directly into the bloodstream and surrounding tissue after being released from the chamber 7 in order to act as an anti-inflammatory there, for example as an antibiotic. The present invention thus provides the advantage of being able to effect interventional treatment of endocarditis directly at its source of inflammation in the diseased heart 14 without subjecting the patient to further stress apart from the transcatheter implantation of a system 2 in accordance with the invention. In addition to the release of medications such as, for example, various antibiotics, use to release anticoagulants or other substances for interventional therapy is also equally possible. In addition to the at least one chamber 7 filled with substances, the present invention furthermore also allows for surface coatings of the system 2 and biologically degradable material, e.g. in the form of resorptive matrices, within the chamber 7 as further release mechanisms for interventional therapy.

[0045] FIG. 4 illustrates a further embodiment of the inventive system 2 in the expanded state of the at least one stent. Here, a replacement heart valve 3 is secured to a stent 5. A skirt region 6 is moreover provided in the aortic retention area of the stent 5, wherein a plurality of individual chambers 7 are in this case provided on the interior side of the stent 5. Each of the chambers 7 thereby has at least one fluidic connection 16 to the ventricular retention area of the stent 5 in order to enable the release of a substance filled into the chambers at that point. The respectively introduced substance flows out of the chambers via the fluidic connections 16 and preferably disperses into the branches of the fluidic connections 16. A distributed release of the substance over the entire extent of the stent 5 is thus enabled. The chambers 7 as well as the fluidic connections 16 are thereby fixed to the stent 5 by means of clamping, sewing or other comparable attachment option.

[0046] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims.