Medical device for treating a heart valve insufficiency or stenosis

• US 9,138,315 B2
• Filed: 06/14/2007
• Issued: 09/22/2015
• Est. Priority Date: 04/13/2007
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology GmbH (JenaValve Technology, Inc.)
• Inventors: Straubinger, Helmut, Jung, Johannes
• Primary Examiner(s): Woo, Julian W
• Assistant Examiner(s): Templeton, Christopher L
• Application Number:
  US11/812,095
• Publication Number:
  US 20080255661A1
• Time in Patent Office: 3,022 Days
• Field of Search: 623/1.11, 623/1.12, 623/2.11, 623/2.14, 623/2.17, 606/108
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor

Abstract

A medical device for treating a heart valve insufficiency, with an endoprosthesis which can be introduced into a patient'"'"'s body and expanded to secure a heart valve prosthesis in the patient'"'"'s aorta with a catheter. In an embodiment, the endoprosthesis has a plurality of positioning arches configured to be positioned with respect to a patient'"'"'s aorta and a plurality of retaining arches to support a heart valve prosthesis. The endoprosthesis includes a collapsed mode during the process of introducing it into the patient'"'"'s body and an expanded mode when it is implanted. The endoprosthesis may be introduced into a patient'"'"'s body and expanded via a catheter. In an embodiment, the catheter has first and second slide mechanisms configured to independently manipulate first and second sleeve elements to sequentially expand the endoprosthesis from the collapsed mode to the expanded mode.

Claims

1. A catheter system comprising:

an endoprosthesis comprising;

a first portion including a plurality of retaining arches, each retaining arch including a first apex;

a second portion including a plurality of positioning arches, each positioning arch including a second apex axially aligned with one of the first apices, the first apices and the second apices pointing in a same direction;

a third portion including a plurality of retaining elements; and

a heart valve prosthesis directly attached to the plurality of retaining arches; and

a catheter configured to releasably retain the endoprosthesis in a collapsed state and sequentially release the endoprosthesis from the collapsed state to an expanded state, the catheter comprising;

a first housing portion for accommodating the first portion of the endoprosthesis;

a second housing portion for accommodating the second portion of the endoprosthesis;

a retaining mechanism defining a plurality of pockets formed therein for receiving the plurality of retaining elements of the endoprosthesis; and

a handle configured to control movement of each of the first housing portion and the second housing portion with respect to the handle;

wherein the first housing portion and the second housing portion are arranged relative to one another such that movement of the second housing portion in a first direction relative to the endoprosthesis, before movement of the first housing portion relative to the endoprosthesis, uncovers the second portion of the endoprosthesis from the catheter while the first portion of the endoprosthesis is accommodated within the first housing portion and the plurality of retaining elements of the endoprosthesis remains engaged with the plurality of pockets of the retaining mechanism and accommodated within the second housing portion;

wherein the second housing portion is further movable in the first direction to uncover and release the plurality of retaining elements of the endoprosthesis from the retaining mechanism; and

wherein the handle includes;

a first slidable element movable with respect to a remainder of the handle along a fixed axial stroke length between first and second limits; and

a second slidable element movable with respect to a remainder of the handle along a fixed axial stroke length between third and fourth limits;

wherein each of the first and second limits has a different axial position than an axial position of the third limit.

2. The catheter system of claim 1, wherein the handle is configured to move the second housing portion with respect to the first housing portion to uncover the second portion of the endoprosthesis while selectively retaining the first portion of the endoprosthesis.

3. The catheter system of claim 2, wherein the first slidable element is coupled to the first housing portion to effect a pre-definable longitudinal displacement of the first housing portion relative to the handle and relative to the endoprosthesis, and wherein the second slidable element is coupled to the second housing portion to effect a pre-definable displacement of the second housing portion relative to the handle and relative to the endoprosthesis.

4. The catheter system of claim 1, wherein both the first housing portion and the second housing portion comprise sleeve elements.

5. The catheter system of claim 1, wherein the first housing portion is movable in a second direction towards the handle of the catheter to uncover the first portion of the endoprosthesis.

6. The catheter system of claim 5, wherein movement of the second slidable element in the first direction corresponds to movement of the second housing portion in the first direction to completely uncover the second portion of the endoprosthesis from the catheter system, and movement of the first slidable element in the second direction corresponds to movement of the first housing portion in the second direction to uncover the first portion of the endoprosthesis.

7. The catheter system of claim 1, wherein the first and second housing portions are arranged telescopically.

8. The catheter system of claim 1, wherein the plurality of pockets of the retaining mechanism includes exactly three pockets having a shape complementary to three retaining elements of the plurality of retaining elements for receiving the three retaining elements.

9. The catheter system of claim 8, wherein the retaining mechanism defines three longitudinal grooves, each groove extending from a corresponding pocket of the plurality of pockets to an end of the retaining mechanism, each groove having a shape complementary to a longitudinal strut portion of a retaining element of the plurality of retaining elements.

10. The catheter system of claim 8, wherein the three pockets are uniformly spaced apart around a circumference of the retaining mechanism, and wherein the retaining mechanism defines three longitudinal grooves, each groove extending from a corresponding pocket to an end of the retaining mechanism, each groove having a shape complementary to a longitudinal strut portion of a retaining element of the endoprosthesis.

11. The catheter system of claim 1, wherein the handle includes a locking element.

12. The catheter system of claim 11, configured to reversibly load and release the endoprosthesis from the catheter system.

13. A catheter system for implanting an endoprosthesis having a plurality of positioning arches, a plurality of retaining arches, and a body portion having a plurality of retaining elements, the catheter system comprising:

a catheter including;

a retaining portion configured to selectively fix the endoprosthesis to the catheter, the retaining portion defining a plurality of pockets formed therein, the plurality of pockets having a shape complementary to the plurality of retaining elements of the endoprosthesis;

a first housing portion configured to selectively retain the plurality of retaining arches in a collapsed state; and

a second housing portion configured to selectively retain the plurality of positioning arches and the body portion in a collapsed state; and

the endoprosthesis, wherein the endoprosthesis includes a heart valve prosthesis directly attached to the plurality of retaining arches, each retaining arch including an apex axially aligned with an apex of a corresponding positioning arch of the plurality of positioning arches and pointing in a same direction as the apex of the corresponding positioning arch;

wherein the first housing portion and the second housing portion are arranged relative to one another such that movement of the second housing portion relative to the endoprosthesis and the retaining portion, before movement of the first housing portion relative to the endoprosthesis and the retaining portion, uncovers the plurality of positioning arches from the catheter while the plurality of retaining arches are retained by the first housing portion and the plurality of retaining elements are retained by the second housing portion.

14. The catheter system of claim 13, wherein the catheter includes a handle, and wherein:

a second operation of the handle moves the first housing portion in a first direction with respect to the retaining portion to uncover the plurality of retaining arches of the endoprosthesis; and

a first operation of the handle moves the second housing portion in a second direction of the catheter, opposite the first direction, with respect to the retaining portion to uncover the plurality of positioning arches of the endoprosthesis.

15. The catheter system of claim 14, wherein the handle includes a first slidable element movable with respect to the handle along a fixed stroke length between first and second limits, and a locking element selectively resisting movement of the first slidable element, wherein the second operation of the handle includes moving the first slidable element along a longitudinal axis of the handle.

16. The catheter system of claim 15, wherein the handle includes a second slidable element movable with respect to the handle along a fixed stroke length between third and fourth limits, wherein the first operation of the handle includes moving the second slidable element along a longitudinal axis of the handle, and wherein each of the first and second limits has a different axial position than an axial position of the third limit.

17. The catheter system of claim 16, wherein the first operation of the handle moves the second housing portion towards a tip of the catheter.

18. The catheter system of claim 15, wherein the second operation of the handle moves the first housing portion towards the handle.

19. The catheter system of claim 13, wherein movement of the second housing portion relative to the endoprosthesis and the retaining portion, before movement of the first housing portion relative to the endoprosthesis and the retaining portion, in a second direction permits the plurality of positioning arches of the endoprosthesis to expand such that the plurality of positioning arches pivot relative to the plurality of retaining arches of the endoprosthesis, and wherein further movement of the second housing portion in the second direction releases the plurality of retaining elements of the endoprosthesis from the plurality of pockets of the retaining portion.

20. The catheter system of claim 19, wherein the plurality of retaining elements are released from the plurality of pockets as a function of the body portion of the endoprosthesis expanding from the collapsed state to an expanded state.

21. The catheter system of claim 19, wherein movement of the first housing portion in a first direction opposite the second direction and with respect to the retaining portion releases the plurality of retaining arches from the collapsed state to an expanded state after the plurality of positioning arches are uncovered and while the plurality of retaining elements of the endoprosthesis remain disposed within the plurality of pockets of the retaining portion.

22. The catheter system of claim 13, wherein the endoprosthesis is configured to clip a flap of a native heart valve between each positioning arch and retaining arch.

23. The catheter system of claim 13, wherein the retaining portion of the catheter is configured to accommodate a portion of the endoprosthesis to which the heart valve prosthesis is not attached.

24. The catheter system of claim 13, wherein the retaining portion defines a plurality of longitudinal grooves each having a cross-sectional dimension smaller than a cross-sectional dimension of each of the plurality of pockets, each groove extending from a corresponding pocket of the plurality of pockets to an end of the retaining portion, each groove having a shape complementary to a longitudinal strut portion of a retaining element of the plurality of retaining elements of the endoprosthesis.

25. A catheter system comprising:

an endoprosthesis comprising;

a plurality of first arches;

a plurality of second arches, each second arch pointing in a same direction as the plurality of first arches;

a plurality of connecting struts parallel to a longitudinal axis of the endoprosthesis when the endoprosthesis is in a collapsed state, wherein each connecting strut connects a pair of adjacent first arches at a first axial location and a pair of adjacent second arches at a second axial location different from the first axial location;

a plurality of retaining elements; and

a heart valve prosthesis directly attached to the plurality of second arches;

a catheter including a tip portion at a first end of the catheter and a handle portion at a second end of the catheter configured to sequentially release the endoprosthesis from the collapsed state to an expanded state, the tip portion including;

a first sleeve element selectively surrounding the first arches of the endoprosthesis and the plurality of retaining elements of the endoprosthesis;

a second sleeve element selectively surrounding the second arches of the endoprosthesis, and

a retaining mechanism defining a plurality of pockets formed therein for receiving the plurality of retaining elements of the endoprosthesis;

wherein the handle portion is configured to manipulate the tip portion to sequentially release the endoprosthesis by;

a first movement of the first sleeve element in a first direction relative to the retaining mechanism to completely uncover the first arches of the endoprosthesis from the catheter while the second arches are covered by the second sleeve element,

a second movement of the second sleeve element in a second direction, opposite the first direction, relative to the retaining mechanism to uncover the second arches of the endoprosthesis after the first movement, and

a third movement of the first sleeve element further in the first direction to uncover the plurality of retaining elements of the endoprosthesis after the second movement.

26. The catheter system of claim 25, wherein each pocket has a curved circumference to match a convex head portion of one of the retaining elements of the endoprosthesis.

27. The catheter system of claim 25, wherein the retaining mechanism is configured to accommodate a portion of the endoprosthesis to which the heart valve prosthesis is not attached.

28. The catheter system of claim 25, wherein the retaining mechanism defines a plurality of longitudinal grooves, each groove extending from a pocket of the plurality of pockets to an end of the retaining mechanism, each groove having a shape complementary to a longitudinal strut portion of a retaining element of the plurality of retaining elements of the endoprosthesis.

29. A catheter system, comprising:

a catheter including a tip portion at a first end of the catheter for sequentially releasing an endoprosthesis from a collapsed state to an expanded state, and a handle portion at a second end of the catheter, opposite the first end, for sequentially manipulating the tip portion; and

the endoprosthesis including a plurality of positioning arches having respective apices projecting toward the handle portion when the endoprosthesis is in the collapsed state, a plurality of retaining arches having respective apices projecting toward the handle portion when the endoprosthesis is in the collapsed state, each apex of a positioning arch being axially aligned with a corresponding apex of one of the retaining arches, wherein the apices of the plurality of the retaining arches define a proximal-most end of the endoprosthesis, and three retaining elements disposed closer to a tip of the catheter than the positioning arches and the retaining arches when the endoprosthesis is in the collapsed state;

wherein the tip portion of the catheter includes;

a first sleeve element surrounding the plurality of positioning arches and the plurality of retaining elements of the endoprosthesis when the endoprosthesis is in the collapsed state,

a second sleeve element surrounding the plurality of retaining arches of the endoprosthesis when the endoprosthesis is in the collapsed state, and

a retaining portion defining three pockets formed therein for receiving head portions of the three retaining elements of the endoprosthesis to fix the location of the endoprosthesis relative to the handle portion and the tip portion of the catheter;

wherein a first manipulation of the handle portion moves the first sleeve element away from the handle portion to uncover the plurality of positioning arches of the endoprosthesis, thereby permitting the positioning arches to expand while the retaining portion and the second sleeve element remain stationary relative to the endoprosthesis, the second sleeve element surrounding the plurality of retaining arches of the endoprosthesis to retain the plurality of retaining arches in the collapsed state; and

wherein a second manipulation of the handle portion, separate from the first manipulation, moves the second sleeve element toward the handle portion to uncover the plurality of retaining arches of the endoprosthesis, thereby permitting the retaining arches of the endoprosthesis to expand while the first sleeve element surrounds the exactly three retaining elements of the endoprosthesis.

30. The catheter system of claim 29, wherein a third manipulation of the handle portion moves the first sleeve element away from the handle portion to uncover the exactly three retaining elements of the endoprosthesis, thereby permitting the retaining elements to expand.

31. The catheter system of claim 30, wherein the first manipulation occurs before the second and third manipulations and the second manipulation occurs before the third manipulation.

32. The catheter system of claim 30, wherein the catheter includes a first slidable element operatively connected to the first sleeve element and movable with respect to the handle portion, wherein the third manipulation of the handle portion moves the first slidable element along a longitudinal axis of the catheter.

33. The catheter system of claim 29, wherein the first manipulation occurs before the second manipulation.

34. The catheter system of claim 29, wherein the handle portion includes a mechanism limiting movement of the first sleeve during the first manipulation.

35. The catheter system of claim 29, wherein the catheter includes a first slidable element operatively connected to the first sleeve element and movable with respect to the handle portion, wherein the first manipulation of the handle portion moves the first slidable element along a longitudinal axis of the catheter.

36. The catheter system of claim 35, wherein the catheter includes a second slidable element operatively connected to the second sleeve element and movable with respect to the handle portion, wherein the second manipulation of the handle portion moves the second slidable element along the longitudinal axis of the catheter.

37. The catheter system of claim 29, wherein the plurality of retaining arches includes three retaining arches and the plurality of positioning arches includes three positioning arches.

38. The catheter system of claim 37, wherein the endoprosthesis is configured to clip a flap of a native heart valve between each positioning arch and retaining arch.