Catheter system for introducing an expandable stent into the body of a patient

• US 9,597,182 B2
• Filed: 05/20/2011
• Issued: 03/21/2017
• Est. Priority Date: 05/20/2010
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Straubinger, Helmut, Mayer, Arnulf, Jung, Johannes
• Primary Examiner(s): Shi, Katherine M
• Assistant Examiner(s): GABR, MOHAMED GAMIL
• Application Number:
  US13/698,910
• Publication Number:
  US 20130178930A1
• Time in Patent Office: 2,132 Days
• Field of Search: 623/1, 623/11, 623/2.11, 623/2.14, 623/2.36
• 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 2/2433 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. A system for introducing an expandable stent into the body of a patient, comprising:

an end portion for accommodating the stent in a collapsed state, the end portion including a holder for releasably fixing the stent, a first sleeve, and a second sleeve, wherein the first and second sleeves have an equal outer cross-section diameter and are moveable relative to each other and relative to the holder, the first sleeve at least partially surrounding the holder;

a handle including a first operating part and a second operating part; and

a shaft including a first elongate member, a second elongate member, and a guiding tube having an outer cross-section diameter less than the outer-cross section diameter of the first and second sleeves, wherein the first elongate member and the second elongate member are at least partly receivable within the guiding tube;

wherein the first elongate member is coupled to the first sleeve and to the first operating part, and the second elongate member is coupled to the second sleeve and to the second operating part;

wherein the guiding tube is releasable from the handle independent of release of the first elongate member and the second elongate member from the handle; and

wherein a distal end of the guiding tube is tapered and abuts the first elongate member.

2. The system of claim 1, wherein an inner cross-section diameter of the second sleeve is smaller than an inner cross-section diameter of the first sleeve to accommodate at least a portion of the stent.

3. The system of claim 1, wherein the second elongate member is disposed coaxially and concentrically within the first elongate member.

4. The system of claim 3, wherein the shaft further includes a holder tube having a distal end connected to the holder and a proximal end connectable to the handle, the holder tube having an outer cross-section diameter less than the outer cross-section diameter of the first elongate member and greater than the outer cross-section diameter of the second elongate member, wherein the holder tube is disposed concentrically and coaxially with the first elongate member and the second elongate member.

5. The system of claim 4, wherein the first and second sleeves are moveable relative to the holder tube.

6. The system of claim 4, wherein the holder tube is rotatable relative to the first elongate member and the second elongate member about a longitudinal axis of the system.

7. The system of claim 4, wherein the end portion includes a holder support section distal to the holder, and the holder tube includes an extension portion having a proximal end connected to the holder and a distal end connected to the holder support section.

8. The system of claim 4, wherein the distal end of the holder tube is rigidly fixed to the holder and the proximal end of the holder tube is rigidly fixed to the handle.

9. The system of claim 1, wherein a length of the first elongate member is substantially the same as a length of the second elongate member.

10. The system of claim 1, wherein the first elongate member includes a flared portion that transitions into the first sleeve.

11. The system of claim 1, wherein a distal end of the second elongate member is connected to an end tip having an atraumatic shape, the holder support section being proximal to the end tip.

12. The system of claim 1, wherein a distal portion of the guiding tube is flexible, and a distal end of the guiding tube terminates proximal to the end portion.

13. The system of claim 1, wherein the first sleeve and second sleeve are moveable relative to the guiding tube.

14. The system of claim 1, wherein the first elongate member includes a flared portion that transitions into the first sleeve, the flared portion having an outer cross-section diameter equal to or greater than an outer cross-section diameter of the guiding tube.

15. The system of claim 1, wherein the guiding tube includes an inner lubricious liner, an outer polymeric jacket, and a coil reinforcement between the inner liner and outer jacket.

16. The system of claim 1, wherein the guiding tube includes at least one radiopaque band.

17. The system of claim 1, wherein a proximal end of the guiding tube includes a port and a check valve for injection of a fluid into the shaft.

18. The system of claim 1, further comprising a guide wire disposed within the second elongate member and moveable relative to the handle, the shaft, and the end portion.

19. The system of claim 1, wherein the shaft further includes a flexural link region, and the handle further includes a third operating part for controlling deflection of the flexural link region.

20. A system for introducing an expandable stent into the body of a patient, comprising:

an end portion for accommodating the stent in a collapsed state, the end portion including a holder for releasably fixing the stent, a first sleeve, and a second sleeve, wherein the second sleeve has an outer cross-section diameter equal to or less than an outer cross-sectional diameter of the first sleeve, the first and second sleeves being moveable relative to each other and relative to the holder;

a handle including a first operating part and a second operating part; and

a shaft including a first tube, a second tube, a holder tube having an outer cross-section diameter less than the outer cross-section diameter of the first tube and greater than the outer cross-section diameter of the second tube, and a guiding tube having an outer cross-section diameter greater than the outer cross-section diameter of the first tube and less than the outer cross-section diameter of the second sleeve;

wherein the first tube is coupled to the first sleeve and to the first operating part, and the second tube is coupled to the second sleeve and to the second operating part; and

wherein a distal portion of the guiding tube is flexible to permit navigation of the distal portion of the shaft through a blood vessel, and a distal end of the guiding tube terminates proximal to the end portion.

21. The system of claim 20, wherein the end portion includes a holder support section distal to the holder and disposed radially between the second tube and the second sleeve.

22. The system of claim 21, wherein the holder support section is tapered.

23. The system of claim 20, further comprising a guide wire comprising a radiopaque material disposed within the second tube and moveable relative to the handle, the shaft, and the end portion, wherein at least a distal portion of the guide wire has a predefined configuration.

24. The system of claim 23, wherein the guide wire includes a shape memory material.

25. The system of claim 20, wherein the guiding tube is releasable from the handle independent of release of the first elongate member, the second elongate member, and the holder tube from the handle.

26. A system for introducing an expandable stent into the body of a patient, comprising:

an end portion for accommodating the stent in a collapsed state, the end portion including a holder for releasably fixing the stent, a first sleeve, and a second sleeve, wherein the second sleeve has an outer cross-section diameter equal to or less than an outer cross-sectional diameter of the first sleeve, the first and second sleeves being moveable relative to each other and relative to the holder;

a handle including a first operating part and a second operating part; and

a shaft including a first tube, a second tube, a holder tube having an outer cross-section diameter less than the outer cross-section diameter of the first tube and greater than the outer cross-section diameter of the second tube, and a guiding tube having an outer cross-section diameter greater than the outer cross-section diameter of the first tube and less than the outer cross-section diameter of the second sleeve;

wherein the first tube is coupled to the first sleeve and to the first operating part, and the second tube is coupled to the second sleeve and to the second operating part;

wherein a distal portion of the guiding tube is flexible, and a distal end of the guiding tube terminates proximal to the end portion; and

wherein the guiding tube is releasable from the handle independent of release of the first elongate member, the second elongate member, and the holder tube from the handle.