TRANSCATHETER EXPANSIVE SYSTEM, METHOD OF MANUFACTURING THIS SYSTEM AND METHOD OF ITS IMPLANTATION

Abstract

The invention relates to a transcatheter expandable system for treating congenital diseases in patients with heart defects, comprising: a first elongated frame, which is in a first state of implantation, having first proximal and distal end regions and defining a first radial periphery of the frame, around which a first covering element is located, extending between the first proximal and distal end regions; a second elongated frame, which is in a second state of implantation and is configured to interact with the said first frame, wherein this second frame has first proximal and distal end regions and defines a second radial periphery of the frame, around which a second covering element is located, axially extending from the second distal region to the second proximal end region,wherein the first frame is configured to radially expand from the first implanted state to the first stable expanded state, wherein the first periphery of the frame will support the first lumen with the first size and define the first central axial channel for receiving the second distal region of the second frame, wherein the second frame is configured to radially expand from the second implanted state to the primary stable expanded state, wherein the second periphery of the frame will support the second lumen with the second size and define the second central axial channel, wherein the said first and second axial channels provide the flow of fluid between the first lumen and the second lumen, wherein the first and second covering elements are configured to provide a seal at the intersection of the first and second frames,wherein the first frame is configured to radially re-expand from a first expanded state to a second stable expanded state, and the second frame is configured to radially re-expand from a primary expanded state to a secondary stable expanded state as the patient grows, wherein the first periphery of the frame will support the first lumen of the grown patient, and the second periphery of the frame will support the second lumen of the grown patient.

Claims

1. A transcatheter expandable system for the treatment of congenital heart defects in patients with heart disease, comprising: a first elongated frame in a first implantable state to facilitate insertion into a first lumen of a patient, wherein the first frame has first proximal and distal end regions and defines a first radial periphery of the frame around which a first covering element is located, extending between said first proximal and distal end regions; and a second elongated frame, which is in a second implantation state to facilitate insertion into a second lumen of a patient and is configured to interact with said first frame, wherein this second frame has second proximal and distal end regions and defines a second radial periphery of the frame, around which a second covering element is located, axially extending from the second distal region to the second proximal end region; wherein said first frame is configured to radially expand from a first implantation state to a first stable expanded state, wherein a first periphery of the frame will support a first lumen of a first size and define a first central axial channel for receiving a second distal region of the second frame, wherein the second frame is configured to radially expand from the second implantation state to a primary stable expanded state, wherein the second periphery of the frame will support a second lumen of a second size and define a second central axial channel, wherein said first and second axial channels provide for the flow of fluid between the first lumen and the second lumen, wherein said first and second covering elements are configured to provide a seal at the intersection of the first and second frames,wherein the first frame is configured to radially re-expand from a first expanded state to a second stable expanded state, and the second frame is configured to radially re-expand from a primary expanded state to a secondary stable expanded state as the patient grows, wherein the first periphery of the frame will support the first lumen of the grown patient, and the second periphery of the frame will support the second lumen of the grown patient.

2. The system of claim 1, wherein the first frame includes a first sealing and locking ring located in the first distal end region and providing sealing and fixation of the first frame in the first lumen.

3. The system according to claim 1 or 2, in which the first frame includes a first sealing and fixing ring located in the first proximal end region and providing sealing and fixation of the first frame in the first lumen.

4. The system of claim 3, wherein the second frame includes a second sealing and locking ring located in the second distal end region, wherein said first and second sealing and locking rings provide a seal and locking between the first and second frames.

5. The system of claim 3 or 4, wherein the second frame includes a second sealing and retaining ring located in the second distal end region, wherein said first and second sealing and retaining rings prevent separation of the first and second frames.

6. The system of any one of claims 1 to 5, wherein the first frame includes a first retaining element located on a first periphery of the frame in a first distal end region, and this first retaining element is configured to radially extend from the first periphery of the frame and engage with the second lumen in the first stable expanded state.

7. The system according to any one of claims 1 to 6, in which said second covering element extends between the second distal region and the central region of the first frame.

8. The system according to any one of claims 1 to 7, wherein said first and second covering elements are configured to provide a seal at the intersection of the first and second frames in the second stable expanded state.

9. The system according to any one of claims 1 to 8, wherein the first and second frames are made of a self-expanding metal material.

10. The system of any one of claims 1 to 9, wherein the first frame comprises a proximal annular expandable mesh element located in a first proximal end region and axially aligned with a distal annular expandable mesh element located in a first distal end region, wherein the proximal annular expandable mesh element and the distal annular expandable mesh element together define said first periphery of the frame.

11. The system of claim 10, wherein the first frame further comprises a first annular spacer element located in axial alignment between the proximal annular expandable cellular element and the distal annular expandable cellular element, wherein said proximal annular expandable cellular element, first annular spacer element and distal annular expandable cellular element collectively define said first periphery of the frame.

12. The system of claim 11, wherein at least one of the proximal annular expandable cellular element and the distal annular expandable cellular element includes a first annular arrangement of struts connected to a second annular arrangement of struts; wherein the first annular arrangement of spacers comprises a plurality of paired first spacers of expandable cells, wherein each of the first spacers of expandable cells has a proximal end region and a distal end region, wherein the proximal end regions of the paired first spacers of expandable cells are connected so that distal end regions extend from these connected proximal end regions, wherein the distal end regions of adjacent paired first spacers of expandable cells are connected to form the first annular arrangement of spacers with a tortuous arrangement of the first spacers of expandable cells; wherein the second annular arrangement of spacers comprises a plurality of paired second expandable cell spacers, wherein each of the second expandable cell spacers has a proximal end region and a distal end region, wherein the proximal end regions of the paired second expandable cell spacers are connected so that distal end regions extend from these connected proximal end regions, wherein the distal end regions of adjacent paired second expandable cell spacers are connected to form a second annular arrangement of spacers with a tortuous arrangement of the second expandable cell spacers.

13. The system of claim 12, wherein the first annular spacer element comprises a plurality of elongated spacer element struts, each spacer element having a proximal end region and a distal end region, wherein each of the proximal end regions of the spacer element struts is connected to a connected proximal end region of a corresponding one of the paired first expandable cell struts of the first annular spacer arrangement of the proximal annular expandable cellular element.

14. The system according to claim 13, in which each of the distal end regions of the spacers of the separating elements is connected to the connected proximal end region of the corresponding one of the paired second spacers of the expandable cells of the second annular arrangement of spacers of the distal annular expandable cellular element.

15. The system according to any one of claims 11-14, in which the first annular spacer element provides for a reduction in the contraction of the length of the first frame during its expansion from the implanted state to the first stable expanded state.

16. The system of claim 15, wherein the first frame further includes at least one intermediate annular spacer element alternating with at least one intermediate annular expandable cellular element, which are positioned in axial alignment between the proximal annular expandable cellular element and the distal annular expandable cellular element and together further define said first periphery of the frame.

17. The system of claim 16, wherein the proximal annular expandable cellular element, the distal annular expandable cellular element, or one or more of said at least one intermediate annular expandable cellular element includes a first annular arrangement of struts connected to a second annular arrangement of struts; wherein the first annular arrangement of spacers comprises a plurality of paired first spacers of expandable cells, wherein each of the first spacers of expandable cells has a proximal end region and a distal end region, wherein the proximal end regions of the paired first spacers of expandable cells are connected so that distal end regions extend from these connected proximal end regions, wherein the distal end regions of adjacent paired first spacers of expandable cells are connected to form the first annular arrangement of spacers with a tortuous arrangement of the first spacers of expandable cells; wherein the second annular arrangement of spacers comprises a plurality of paired second expandable cell spacers, wherein each of the second expandable cell spacers has a proximal end region and a distal end region, wherein the proximal end regions of the paired second expandable cell spacers are connected so that distal end regions extend from these connected proximal end regions, wherein the distal end regions of adjacent paired second expandable cell spacers are connected to form a second annular arrangement of spacers with a tortuous arrangement of the second expandable cell spacers.

18. The system of claim 17, wherein one or more of said at least one intermediate annular spacer element comprises a plurality of elongated spacer element struts, each spacer element having a proximal end region and a distal end region, wherein each of the proximal end regions of the spacer element struts is connected to a connected proximal end region of a corresponding one of the paired first spacer element expandable cells of a first annular spacer arrangement of a first adjacent annular expandable cellular element, wherein each of the distal end regions of the spacer element struts is connected to a connected proximal end region of a corresponding one of the paired second spacer element expandable cells of a second annular spacer arrangement of a second adjacent annular expandable cellular element.

19. The system according to claim 18, in which at least one of the proximal end regions of the spacers of the separating elements is connected to the connected proximal end region of the corresponding one of the paired first spacers of the expandable cells of the first annular arrangement of spacers of the first adjacent annular expandable cellular element by means of a first intermediate connecting element; wherein at least one of the distal end regions of the spacers of the separating elements is connected to the connected proximal end region of the corresponding one of the paired second spacers of the expandable cells of the second annular arrangement of spacers of the second adjacent annular expandable cellular element by means of a second intermediate connecting element.

20. The system of claim 19, wherein each of the first intermediate connecting elements comprises a first flexible central body with a first connecting region for connecting to a proximal end region of a selected spacer of the separating element and a second connecting region for connecting to a corresponding connected proximal end region of a selected one of the paired first spacers of the expandable cells of the first annular arrangement of spacers of the first adjacent annular expandable cellular element; wherein each of the second intermediate connecting elements comprises a second flexible central body with a first connecting region for connection with the distal end region of the selected spacer of the separating element and a second connecting region for connection with the corresponding connected proximal end region of the selected one of the paired second spacers of the expandable cells of the second annular arrangement of spacers of the second adjacent annular expandable cellular element.

21. The system of any one of claims 17-20, wherein the first annular arrangement of struts and the second annular arrangement of struts of one or more of the proximal annular expandable cellular elements, the selected intermediate annular expandable cellular element and the distal annular expandable cellular element are connected by means of a first covering element.

22. The system according to any one of claims 17-21, in which the connected distal end regions of a given one of the adjacent paired first struts of the expandable cells of the selected annular expandable cellular element are connected to the connected distal end regions of a corresponding one of the adjacent paired second struts of the expandable cells of the selected annular expandable cellular element to form a junction of the expandable cells for connecting the first and second annular arrangements of struts of the selected annular expandable cellular element.

23. The system of claim 22, wherein said selected annular expandable cellular element comprises a distal annular expandable cellular element.

24. The system according to claim 23, in which a first retaining element is connected to the specified place of connection of the expandable cells, which element is configured to radially move away from the place of connection of the expandable cells and engage with the second clearance during installation.

25. The system according to any one of claims 16-24, in which one or more of said at least one intermediate annular spacer elements provides for a reduction in the contraction of the length of the first frame during its expansion from the implanted state to the first stable expanded state.

26. The system according to any one of claims 1 to 25, in which said first and second frames are configured to be installed in a telescopic arrangement to adjust the overall length of the transcatheter expandable system.

27. The system of any one of claims 1 to 26, wherein the first frame is configured to subsequently re-expand from the second expanded state to the third stable expanded state, and the second frame is configured to subsequently re-expand from the secondary expanded state to the tertiary stable expanded state as the patient grows further, wherein the first periphery of the frame will support the first lumen of the grown patient, and the second periphery of the frame will support the second lumen of the grown patient.

28. A method for manufacturing a transcatheter expandable system for the treatment of congenital diseases in patients with heart defects, comprising the following steps: forming a first elongated frame in a first implanted state to facilitate insertion into a first lumen of a patient, wherein the first frame has first proximal and distal end regions and defines a first radial periphery of the frame around which a first covering element is positioned, extending between said first proximal and distal end regions; and forming a second elongated frame, which is in a second implantation state to facilitate insertion into a second lumen of a patient and is configured to interact with the first frame, wherein the second frame has first proximal and distal end regions and defines a second radial periphery of the frame around which a second covering element is positioned, axially extending from the second distal region to the second proximal end region; wherein said first frame is configured to expand radially from a first implantation state to a first stable expanded state, wherein a first periphery of the frame will support a first lumen of a first size and define a first central axial channel for receiving a second distal region of the second frame, wherein the second frame is configured to expand radially from the second implantation state to a primary stable expanded state, wherein a second periphery of the frame will support a second lumen of a second size and define a second central axial channel, wherein said first and second axial channels provide for the flow of fluid between the first lumen and the second lumen, wherein said first and second covering elements are configured to provide a seal at the intersection of the first and second frames; wherein the first frame is configured to radially re-expand from the first expanded state to the second stable expanded state, and the second frame is configured to radially re-expand from the primary expanded state to the secondary stable expanded state as the patient grows, wherein the first periphery of the frame will support the first lumen of the grown patient, and the second periphery of the frame will support the second lumen of the grown patient.

29. A method for implanting a transcatheter expandable system for the treatment of congenital diseases in patients with heart defects, comprising the following steps: implanting a first elongated frame in a first implantation state to facilitate insertion into a first lumen of a patient, wherein the first frame has first proximal and distal end regions and defines a first radial periphery of the frame around which a first covering element is positioned, extending between said first proximal and distal end regions; expanding the first framework from a first implanted state to a first stable expanded state, wherein the first periphery of the framework will support a first lumen of a first size and define a first central axial channel; implanting a second elongated frame, which is in a second implantation state to facilitate insertion into a second lumen of a patient and is configured to interact with said first frame, wherein this second frame has first proximal and distal end regions and defines a second radial periphery of the frame around which a second covering element is positioned, axially extending from the second distal region to the second proximal end region; placing the distal end region of the second frame in the first central axial channel defined by the first frame; and expanding the second framework from the second implanted state to the primary stable expanded state, wherein the second periphery of the framework will support a second lumen of a second size and define a second central axial channel, wherein said first and second axial channels provide for the flow of a fluid medium between the first lumen and the second lumen, wherein said first and second covering elements are designed with the ability to provide a seal at the intersection of the first and second frameworks; wherein the first frame is configured to radially re-expand from the first expanded state to the second stable expanded state, and the second frame is configured to radially re-expand from the primary expanded state to the secondary stable expanded state as the patient grows, wherein the first periphery of the frame will support the first lumen of the grown patient, and the second periphery of the frame will support the second lumen of the grown patient.

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