Catheter system for introducing an expandable heart valve stent into the body of a patient, insertion system with a catheter system and medical device for treatment of a heart valve defect

• US 20110288626A1
• Filed: 05/20/2010
• Published: 11/24/2011
• Est. Priority Date: 05/20/2010
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Jung, Johannes, Straubinger, Helmut, Mayer, Arnulf
• Granted Patent: US 10,856,978 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61M 2025/09141 made of shape memory alloys which take a particular shape at a certain temperature

Abstract

The invention relates to catheter system for introducing an expandable heart valve stent (150) into the body of a patient, the catheter system comprising: a catheter tip (10) having a seat portion for accommodating the stent (150) in its collapsed state and a stent holder (15) for releasably fixing the stent (150), wherein the seat portion is constituted by a first sleeve-shaped member (11) and a second sleeve-shaped member (21), said sleeve-shaped members (11, 21) being moveable relative to each other and relative to the stent holder (15), and a catheter shaft (30) for connecting the catheter tip (10) to a handle (70). The catheter shaft (30) comprising: first force transmitting means (31) connected to the first sleeve-shaped member (11), second force transmitting means (41) connected to the second sleeve-shaped member (21) and a distal end section connectable to second operating means (81) of the handle (70), and guiding means (51) having a passageway extending there between, wherein the first and second force transmitting means (31, 41) are at least partly received within the passageway such as to be moveable relative to the guiding means (51), and wherein the proximal end of the guiding means (51) terminates distal to the catheter tip (10).

Claims

1-15. -15. (canceled)

16. A catheter system for implanting a self-expandable endoprosthesis including a stent, the catheter system comprising:

a catheter tip disposed adjacent a distal end of the catheter system and configured for accommodating the endoprosthesis in a collapsed state, the catheter tip including a holder for releasably fixing the endoprosthesis to the catheter system, a first sleeve member, and a second sleeve member, wherein the first and second sleeve members are moveable relative to each other and relative to the holder;

a catheter handle disposed adjacent a proximal end of the catheter system, the catheter handle including a first operating mechanism and a second operating mechanism; and

a catheter shaft connecting the catheter tip to the catheter handle, the catheter shaft including a first tubular member having a distal end connected to the first sleeve member and a proximal end connected to the first operating mechanism, a second tubular member having a distal end connected to the second sleeve member and a proximal end connected to the second operating mechanism, and a third tubular member defining a passageway extending therein having a distal end that terminates proximally with respect to the catheter tip and having a cross-sectional size less than a cross-sectional size of the catheter tip.

17. The catheter system according to claim 16, wherein the third tubular member includes an inlet disposed adjacent a proximal end of the third tubular member and configured to permit an injection of fluid into the third tubular member.

18. The catheter system according to claim 17, wherein the third tubular member includes a check valve disposed at the proximal end of the third tubular member and configured to selectively restrict fluid from leaking out of the inlet.

19. The catheter system according to claim 16, wherein the second tubular member is disposed concentrically within the first tubular member.

20. The catheter system according to claim 16, wherein the first tubular member has a length that is substantially the same as a length of the second tubular member.

21. The catheter system according to claim 16, wherein the distal end of the first tubular member terminates in a flared section that defines a transition to the first sleeve member.

22. The catheter system according claim 16, wherein the first tubular member is made from braided wire.

23. The catheter system according claim 16, further including a fourth tubular member having a distal end connected to the holder and a proximal end connected to the catheter handle, wherein the fourth tubular member is disposed concentrically within the first tubular member and disposed concentrically outside the second tubular member.

24. The catheter system according to claim 23, wherein the distal end of the fourth tubular member is rigidly fixed to the holder and a proximal end of the fourth tubular member is rigidly fixed to the catheter handle.

25. The catheter system according to one of the claim 16, wherein the third tubular member is disposed concentrically outside the first and second tubular members.

26. The catheter system according to claim 16, wherein the distal end of the first tubular member terminates in a flared section that defines a transition to the first sleeve member, the flared section having a cross-sectional size equal to or greater than a cross-sectional size of the third tubular member.

27. The catheter system according to claim 16, wherein the third tubular member is releasably connected to the catheter handle.

28. The catheter system according to claim 16, wherein the first sleeve member and the second sleeve member overlap telescopically.

29. The catheter system according to claim 16, wherein the endoprosthesis further includes a prosthetic valve attached to the stent, and the stent and the prosthetic valve are held in a collapsed state within the catheter tip by the first and second sleeve members.

30. A method of releasing an endoprosthesis including a stent having at least one positioning hoop and a prosthetic valve attached to a portion of the stent, the method comprising:

positioning the endoprosthesis in a collapsed configuration relative to a native heart valve;

manipulating a first operating mechanism of a catheter to affect movement of a first sleeve element in a first direction toward a handle of the catheter to uncover the at least one positioning hoop and permit the at least one positioning hoop to expand while maintaining the portion of the stent and the prosthetic valve in a collapsed configuration;

positioning the at least one positioning hoop within a pocket of the native heart valve; and

manipulating a second operating mechanism of the catheter to affect movement of a second sleeve element in a second direction away from the handle of the catheter to uncover a first section of the portion of the stent and permit the first section to expand while maintaining a second section of the portion of the stent in a collapsed configuration;

wherein the first operating mechanism affects movement of the first sleeve element via a first tube extending between the handle and the first sleeve element and the second operating mechanism affects movement of the second sleeve element via a second tube extending between the handle and the second sleeve element, the first tube being disposed radially outside the second tube;

wherein the first tube and the second tube are both disposed radially within and configured to be movable relative to a third tube having a first end thereof fixedly attached to the handle of the catheter.

31. The method of claim 30, further including affecting movement of the position of the endoprosthesis relative to the native valve by manipulating the third tube.

32. The method of claim 30, further including injecting fluid through an inlet in the third tube.

33. The method of claim 30, wherein the endoprosthesis is connected to the catheter via a holder, and the holder is fixedly connected to the handle of the catheter via a fourth tube.

34. The method of claim 33, wherein the fourth tube is disposed radially outward from the second tube and radially inward of the first tube.

35. The method of claim 30, wherein the first sleeve element includes a flared region adjacent the first tube and a second end of the third tube terminates adjacent the flared region of the second sleeve element.

36. The method of claim 30, further including further manipulating the first operating mechanism in the first direction to affect further movement of the first sleeve in the first direction to uncover the second section of the portion of the stent and permit the second section to expand.

37. The method of claim 30, wherein the at least one positioning hoop is a plurality of positioning hoops.